Acupuncture for Chronic Low Back Pain

August 14, 2019

Tamara Syrek Jensen, JD, Director, Evidence and Analysis Group
David Dolan, Lead Analyst, Evidence and Analysis Group
Susan Miller, MD, Lead Medical Officer, Evidence and Analysis Group

RE: National Coverage Analysis (NCA) for Acupuncture for Chronic Low Back Pain (CAG- 00452N)

Dear Ms. Syrek Jensen, Mr. Dolan, and Dr. Miller:

On behalf of the Board of Directors of the National Center for Acupuncture Safety and Integrity (NCASI), we appreciate the opportunity to comment on the Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N).

We strongly oppose the proposed training requirements for clinicians to provide acupuncture.
The requirement for “a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM)” is a barrier: this proposed training requirement would prohibit over 50% of licensed acupuncturists from furnishing acupuncture. We request that supervision by other licensure types be removed.

We propose the following training requirements for clinicians to provide acupuncture:
Physicians (as defined in 1861(r)(1)), physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and licensed acupuncturists may furnish acupuncture in accordance with applicable state requirements.

Thank you and if you have any questions, please feel free to contact us.

Sincerely,

NCASI, Board of Directors
www.acupuncturesafety.org

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To whom it may concern:

This is an amazing opportunity for acupuncture to show its effectiveness for chronic low back pain, but I find it imperative that it is limited to licensed acupuncturist as credited by NCCAOM. Other health professionals have limited class hours and training on proper treatment using all of the tools acupuncture has to offer. Those credited by NCCAOM have atteneded an accredited graduate school that is a the least amount of time 3 years, and gives a much broader and deeper understanding of how to effectively treat a injury with acupuncture.

Please hear this and act accordingly.

Thank you.

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First of all I want to thank the CMS for their consideration of this topic. This represents a giant step towards the incorporation of acupuncture into national health care.

My petition/comment is regarding the section that includes “auxiliary providers”: to please be changed to more clearly name “Licensed Acupuncturists or Acupuncture Physicians”. The qualifications for auxiliary providers exactly describe this licensure group.

Also I would like to comment/ask that the supervision required during the study portion be done only by an MD. Supervision by other licensure types does not have a precedent, nor does it add in any way to the safety or quality of the trials.

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I am a Licensed Acupuncturist practicing in California as a Primary Health Care Provider since 1994.

I support Medicare adding Acupuncture as an mandatory benefit.In fact I worked with a coalition of Acupuncturists for 3 years from 1994 to 1997 towards this goal. We complied with everything asked of us by Medicare, including working with the FDA and getting Acupuncture needles taken off the experimental device list. At that time Acupuncture Needles were the lowest adverse event medical device in the US History of medical devices!

I support Medicare studying the efficacy of Acupuncture and adding it as a mandatory medical benefit to all Medicare insured people. However it is very important to the public and our profession, that Licensed Acupuncturist perform and supervise the treatments. We want to have only those with adequate training be involved in delivering care, so that the public is receiving safe and effective care at all times. Even is safety was not an issue, which it is, we have a right to our scope of practice being respected and protected as it is for all other medical professions. Just because Acupuncture works and is gaining acceptance, does not give anyone or any group the right to take it from the professionals who are the experts in it.

Sincerely, Carolyn Pole, L.Ac.

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Dear CMS,

I am writing to advocate for the inclusion of acupuncture for chronic low back pain (“CLBP”) into Medicare. In this comment I will focus on:

1. The growing consensus that acupuncture is helpful for CLBP and the need for public policies to reflect that consensus.
2. Navigating common concerns with regard to acupuncture studies, particularly in RCTs.
3. The importance of specifying that Licensed Acupuncturists are included as providers in any implemented policies/guidelines/legislation.

1. Growing consensus

Because the CMS investigators may already be aware of the longstanding research literature regarding acupuncture for CLBP, I would like to highlight one recent – and significant - point of consensus. In the July 15, 2019 issue of American Family Physician (the journal of the influential American Academy of Family Physicians), reviewers concluded that acupuncture should receive an evidence rating of “A” in the treatment of CLBP; this was offered on the basis of “Consistent findings from multiple systematic reviews of RCTs”. (See https://www.aafp.org/afp/2019/0715/p89.html or Am Fam Physician. 2019 Jul 15;100(2):89-96.)

While a range of data should be considered in CMS’s evaluation, I would suggest that this significant judgment from American Family Physicians provides public policymakers and legislators with a solid rationale for covering acupuncture for CLBP through Medicare.

There is also an important social aspect to this development. Since many family doctors rely on American Family Physician and its evidence summaries, it is reasonable to assume that many Medicare patients will hear from their family physician that acupuncture could likely help their CLBP. These will be patients who will have to decide between potentially inexpensive (but hazardous) treatment with opioids on the one hand verses acupuncture on the other. It seems reasonable that Medicare patients might want their coverage to mirror their physicians’ recommendations for safe and effective – and affordable - acupuncture therapy.

2. Navigating common concerns with regard to acupuncture studies, particularly RCTs.

As a Licensed Acupuncturist who graduated from the Maryland University of Integrative Health with a Doctor of Oriental Medicine degree (reflecting approximately 3700 hours of training), I have read many acupuncture studies – and the skeptical critiques of those studies. Often the skeptics of acupuncture point to the similar effect sizes between “true acupuncture” and “sham acupuncture” and make the accusation that acupuncture is merely a placebo.

From the standpoint of a practicing acupuncturist, there are good reasons why these effect sizes may be similar. One has to do with the quality of the “true” acupuncture in trials which (for the sake of uniformity) is often a generic treatment that is not properly differentiated and individualized according to the principles of Chinese medicine. It is therefore reasonable to suggest that results in the real-world acupuncture clinic (where the heuristics of Chinese medicine are properly practiced) are likely to exceed the results of the “true” acupuncture of the research world.

Moreover, the “sham” acupuncture applied during research trials is rarely, if ever, a physiologically inert control. This is because any stimulation of acupuncture points (even with a toothpick, acupressure, etc.) appears capable of evoking some sort of somatic response.

There is a further complication with “sham” acupuncture: historical acupuncture literature recognizes “meridians” that extend beyond the 12 “primary meridians” used in studies. “Sinew meridians” exist as whole regions between the 12 primaries. So, when trialists attempt to needle areas other than the 12 primary meridians as sham controls, they are invariably needling “sinew meridians”. Needling or stimulating a sinew meridian constitutes a treatment…just a treatment of a different sort, and this shows up in the effect sizes of “sham” acupuncture.

For these reasons, I would suggest that CMS investigators not be swayed by dismissive arguments that use “sham” acupuncture effect sizes to discount positive research outcomes. The most telling comparison for effect sizes in acupuncture studies is not between “true” and “sham”, but between “true” acupuncture and no treatment.

3. The importance of specifying that Licensed Acupuncturists are included as providers in any implemented policies/guidelines/legislation.

Finally, I feel that it is important to specify in any potentially adopted policies, guidelines and/or legislation that Licensed Acupuncturists be listed as eligible providers of acupuncture for CLBP. While I am happy to see any licensed provider who is well-trained offer the gift of acupuncture to patients, acupuncture is like any other discipline in that extensive training begets deeper competence. Licensed Acupuncturists are specialists that undergo training that far exceeds the requirements of any other acupuncture certification. While trained MDs, DOs, etc. are certainly capable of performing acupuncture safely, Medicare subscribers should also have access to the providers who specialize in the field of acupuncture and have the most extensive tools and resources to care for them. Licensed acupuncturists train extensively and specifically in the field of acupuncture in order to bring the richest depths of the modality to life in the treatment room.

Thank you considering these critical concerns in your deliberations!

Respectfully submitted,

Daniel Melton, DOM, L.Ac.

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Aug 14, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

As a Licensed Acupuncturist in the state of Colorado and a Doctor of Oriental Medicine in the state of Colorado, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a stakeholder affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹ The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE).³ We propose alternate language for this section in toto that simply reads:

Dear Mr. Dolan and Dr. Miller,

My name is Jessica Sylvanson and I am a licensed acupuncturist in the state of Colorado where I have practiced for 13 years. I am happy to see that CMS is proposing to conduct this study on Acupuncture for chronic low back pain, as it is something I treat regularly with very favorable outcomes. I am hopeful that this treatment will be available to Medicare and Medicaid patients, and help give them alternatives to opioids.

However, I am writing today regarding acupuncturists participation in the CMS acupuncture study. A letter was sent by the Acupuncture Association of Colorado. I concur with these statements, and want to further add my concerns about the qualification of, "a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM)."

This certification is not required by every state for licensure and is not representative of a national standard for the profession of acupuncture. The NCCAOM examinations can be used as one of many criteria for state licensure (in lieu of a state licensing examination), but other equivalent examinations can be used as well. California has its own examination that is of extremely high quality and is maintained by the California Acupuncture Board. Some states accept both the California Acupuncture Board's exam and the NCCAOM exam. Some states also specify in statute that if an exam of equal or greater quality emerges they will accept that as well.

The NCCAOM certification is a separate product which requires the passage of their examinations and a fee. It can be purchased directly on graduation from an entry level degree program and after that is renewed every four years. Furthermore, they have recently allowed any acupuncturist in California who didn't take their exam to purchase this certification without any further action on their part. This certification does not represent any specialized training, it is merely a continuing education verification. After it's initial purchase, it is renewed every four years to show that the certification holder has completed 15 continuing education credits a year that have been approved by the NCCAOM. However, there are states that govern their own CEU credits as well with equal or greater standards.

In my state of Colorado the NCCAOM current certification is not required for continued licensure of an acupuncturist. Even in states where it is required for continued licensure there are many acupuncturists practicing who have been "grandfathered" in.

The reality is there is absolutely no evidence or studies that show that acupuncturists who choose or are mandated to purchase this certification are safer or more effective than those who do not. Standards for entry level degree programs for acupuncture are maintained by the ACAOM (www.ACAOM.org) and are set at a minimum of 1950 hours of course work with a minimum of 660 hours of clinical skills work. My entry level degree program exceeded that with over 3000 hours of coursework with 1200 hours of clinical skills internships. These programs are where the KSA's and safety are taught for our profession. There are schools in other countries that also maintain high standards and should be considered as a qualification for state licensure as well.

Please consider changing your criteria for this study. The main criterion for acupuncturists, as it is listed for physicians, should be state licensure. The "current certification" from the NCCAOM is not a national standard and actually excludes approximately 50% or more of the profession. I have been licensed and practicing in Colorado for 13 years, and this requirement would personally prohibit me from participating in your study. I currently have many patients who would qualify and would not be able to participate either.

Thank you for your time and consideration of these comments and best wishes for the proposed study,
Jessica Sylvanson, L.Ac.

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Thank you for the time you have spent reviewing the evidence and reference citations submitted for the Jan/Feb 2019 comment period. I appreciate your decision to require STRICT-A reporting guidelines for future funded research. Thank you.

To your decision about acupuncturists/auxiliary personnel being supervised “auxiliary personnel furnishing acupuncture must be under direct supervision…”, what is your reference point for this? My understanding is that supervisory language is needed because Medicare law does not currently list licensed acupuncturists (LAcs) as “covered providers”. However, direct clinical supervision is unnecessary. LAcs are licensed independent practitioners (LIPs) by state law. For CMS coverage purposes in this decision, why not just administrative supervision by a physician (simplest choice most consistent with current practices) or indirect clinical supervision (not consistent with current practices, but a possible workaround for a special case like running a clinical research study).

For more about licensed acupuncturists as LIPs, I recommend this citation:
Gale M, Hospital Practice: Recognition of Acupuncturist as a Licensed Independent Practitioner (LIP). Meridians: JAOM, 2016 3(4): 11-16, 41.
http://www.meridiansjaom.com/files/MERIDIANSJAOM_A003.4.pdf

However, this article was published in 2016 and there have since been 2 major professional updates since this paper that also support LAcs as LIPs, and they are:

(1) the official BLS standard occupational code for acupuncturists, 29-1291 Acupuncturist, was published in 2018 https://blog01.thehospitalhandbook.com/2018/02/the-bls-standard-occupational-code-for.html and

(2) the VA unique staffing code for acupuncturists was published 2/07/2018, 5005/100 Staffing—Acupuncturist. [Also, please note this VA staffing code as an update to your reference to its potential publication on p. 22 of this decision memo, CAG-00452N.] https://blog01.thehospitalhandbook.com/2018/02/the-va-occupational-code-for-licensed.html

I am looking forward to seeing how CMS’s work here coincides with NCCIH HEAL initiatives and my colleagues working in hospital-based practice and other settings your decision directly affects. Thank you for your work.

Respectfully,
Megan Kingsley Gale, MSAOM
The Hospital Practice Handbook Project for Acupuncturists and Their Hospital Sponsors
www.thehospitalhandbook.com

I appreciate all your work on this task. This comment is to provide you with more background information/research citations on mechanisms of action. I noticed about p. 8 under "Background" and acupuncture, before "III. History of Medicare Coverage", on "mechanisms of action" for acupuncture, you may not be aware of some of the research citations. I recommend references labeled about #13 or 14 through 31 (citations related to mechanisms of action) on the Evidence Based Acupuncture webpage, "Acupuncture: An Overview of Scientific Evidence" https://www.evidencebasedacupuncture.org/acupuncture-scientific-evidence/

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

August 14, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

As a Licensed Acupuncturist in private practice in the State of North Carolina since 2005 and a Diplomate in Oriental Medicine with the National Certification Commission of Acupuncture and Oriental Medicine, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. Licensed acupuncturists seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales.

Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹

The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). ³ We propose alternate language for this section in toto that simply reads:

While as a licensed acupuncturists I strongly support the proposed study of acupuncture for chronic low back pain and would like to thank the CMS for its consideration of this topic, I am also concerned about some of the details in the proposal.

The requirement of NCCAOM certification beyond California state licensure is an onerous burden that will exclude many qualified practitioners from participating.

In addition, the provision that licensed acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists is counter to California state law and should be corrected.

Thank you for your consideration of my comments and for providing this opportunity. Acupuncture stands as one of the most promising options for the non-pharmacological treatment of pain when practiced by licensed acupuncturists, and I am excited to see CMS begin its diligent work in this study.

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A review of literature on acupuncture for pain quickly reveals severe design flaws when licensed acupuncturists are not included in the design and execution of acupuncture trials. Many studies do not take into consideration the breadth of information that acupuncturists have on the subject, including nuances of theory, diagnosis, and implementation, and the design is often overly simplistic to the point of making the results useless.

I'm very excited that more acupuncture research is being done, but insufficiently designed and executed studies dilute the body of knowledge that research is intended to reveal.

To this end, these, here are some comments/ recommendations to augment the proposed study:

1. All licensed acupuncturists to be included in this study
2. Recognition of the California Acupuncture Licensing Exam to be equivalent to the NCCAOM exam for the purposes of this study.
3. Licensed acupuncturists to be recognized as independent practitioners, without the need for supervision by physician assistants, nurse practitioners, and/or clinical nurse specialists

Including licensed acupuncturist at all stages of acupuncture research, from design to implementation, is the only way to develop useful, conclusive data about the efficacy of acupuncture for pain.

In an age of abuse and overuse of pain medications, it is vital that this research be done well.

Thank you.

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Dear Mr. Dolan and Dr. Miller:

I am a licensed acupuncturist in California and I am nationally certified by the NCCAOM as a diplomate in Oriental Medicine. I practice in Pasadena, CA. I am also a member of CalATMA. Thank you for requesting comments regarding efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare.

I have the same concerns as CalATMA, as stated in their letter dated 8/4/19 to you, regarding the language in the proposed decision memo. The language (regarding those practitioners who may perform acupuncture in their state) may affect the decisions made based on the outcomes of the studies.

Please review the information as outlined in the CalATMA letter and consider changing the language to reflect what they recommend - that "Licensed acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture".

Thank you for your consideration of my comments and for providing this opportunity for our field. I believe that acupuncture can be very beneficial to help patients manage pain and to provide overall wellness and good health.

Sincerely,
Jean Tom, LAc

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

July 24, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

As a Member of the Acupuncture Society of New York (ASNY) and the American Society of Acupuncturists, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As my colleagues in the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

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To David Dolan, Dr. Miller, and team

Thanks to CMS for studying the effects of Acupuncture for chronic low back pain! Having my Doctorate in Acupuncture and Chinese Medicine combined with over 13 years of clinical experience, I know first hand how effective acupuncture treatments can be for low back pain and other pains.

While this is an exciting first step, based of the wording of the initial memo I have some concerns and comments.
First the wording about WHO is qualified to perform acupuncture needs to be clarified as Licensed Acupuncturists are by far the most qualified with over 3,000 hours of training dedicated to acupuncture, which in no way can be compared to a medical professional who takes a 50-300 hour course in acupuncture. They are not close to being proficient in the skills it takes to safely, effectively, and consistently apply acupuncture treatments anywhere near the level that a licensed acupuncturist can.
So with that being said I would like to see the following section adjusted:

"Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnelmay furnish acupuncture if they meet all applicable state requirements and have:

I am a practicing L.Ac. In the states of Hawaii, NY and CA. I am so happy to hear that there is a study on the affects of acupuncture on low back pain.
I am concerned that the study will be conducted with many practitioners with lower training hours than an L.Ac. In the state of Hawaii only L.Ac’s can practice acupuncture. No MDs,No PTs no one except trained licensed acpincturist. My trading consisted of 4 years of graduate Masters of Science. Approx 3,000 plus hours of training. As you would not call an electrician for a plumbing problem not should you conduct a study without only full trained acupuncturist on board in the study, conducting the treatments.
This is a beautiful medicine that the WHO supports. Make sure that L.Ac’s are the practitioners doing the treatments.

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The California Acupuncture License has never been licensed by NCCAOM, so the above regulation makes California acupuncturists unable to participate the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. ! I hope CMS.gov will amend this rule!

Acupuncture treatment begins with acupuncturist, not by Western Physician assistants, nurse practitioners, clinical nurse specialists or other medical personnel; therefore, acupuncturists should be supervised and manage by their own committees, assisted by the National Health Administration, rather than being supervised by Western doctors and medical staff to conduct the research to secure the acupuncture professional! Thank you!

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Dear Dr. Miller and Mr. Dolan,

I am so grateful for the efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a Licensed Acupuncturist (L.Ac.) I want to seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below: Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

I'm an acupuncturist at Wasatch Community Acupuncture, a large non-profit clinic that offers acupuncture on a $15-$40 sliding scale. We are members of the national cooperative called the People's Organization of Community Acupuncture (POCA), that is committed to making acupuncture accessible and affordable. I have been practicing acupuncture for over 8 years and chronic low back pain is one of the most common ailments that we treat. As with any medicine acupuncture doesn't work 100% of the time but it works much of the time and has the potential to change peoples quality of life. Acupuncture changed my life of chronic pain, which I why I became an L.Ac. If access is increased and more people receive acupuncture for things like chronic low-back pain the need for and use of pain medications will dramatically decrease. Acupuncture is minimally invasive and inexpensive, making it ideal for chronic issues. Acupuncture also has a relaxing effect on the nervous system, many patients also report a reduction in their stress and anxiety levels, an added bonus. Please, if possible make acupuncture a part of Medicare services.

Also, if Medicare/Medicaid should cover acupuncture for those with chronic low back pain, I hope that your agency will work with all licensed acupuncturists. If they have a valid state license, then they are qualified. Please do not limit this only to acupuncture practitioners who maintain national certification with the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). Every licensed practitioner takes the NCCAOM board exam or the very similar California exam. There is no difference in the quality of care that comes from acupuncturists who pay to keep their national certification and those who do not. Thank you for your consideration of this important issue.

Kristen Phipps

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I am writing to protest dysfunctional errors and misconceptions in CMS's proposed study of acupuncture for chronic low back pain, which, if adopted, would jeopardize public safety by inverting the training/education/licensing hierarchy by putting untrained and unqualified personnel in supervisory positions over licensed acupuncturists who have more training in acupuncture safety and efficacy than mid-level providers.

The proposed document would allow certain non-acupuncturists to provide acupuncture services,without specifying training, education and licensing for such practitioners, thus jeopardizing public safety.

It excludes California licensed acupuncturists who have not also been certified by the NCCAOM. This makes no sense, as California currently has among the most stringent and highest educational and safety standards for licensing acupuncturists in the U.S.

It labels licensed acupuncturists as "auxiliary personnel." In California and many other states, Licensed/Certified Acupuncturists are by statute primary care providers and independent medical professionals with Doctorate degrees, with more education and training requirements than mid-level providers such as physician assistants and nurses.

It initiates support for supervision of acupuncturists by physician assistants, nurse practitioners and/or clinical nurse specialists. See above objections.

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Thank you for your interest in and considering covering acupuncture for Medicare and Medicaid patients. These patient populations have long awaited the inclusion of acupuncture treatments as part of their insurance plans. So many private insurance plans, and Medical, have already included it in their coverage since it is recognized and has been established by numerous studies that acupuncture is beneficial in the treatment of pain. And as you know, the opioid crisis emphasizes the importance of utilizing non-prescription drugs to treat pain. In my private practice, as well as at Kaiser Permanente, where I work part-time, most patients I treat are over the age of 65, and have experienced a reduction in low back pain, as well as an improved quality of life.

The practice of acupuncture is an academic, as well as hands on, endeavor, and only properly educated and trained persons should be allowed to needle, primarily to ensure patient safety. Medical doctors in most states have an abbreviated education route they can pursue to perform acupuncture under their license. And the only other party that obtains such licensure in the U.S. is a licensed acupuncturist or state equivalent. It would be prudent and less costly for CMS to clearly state the certification/licensure requirements for those performing acupuncture treatments to “licensed acupuncturists or state equivalent”.

While licensed acupuncturists in California are primary health care providers, I believe an MD for the CMS study purposes is necessary. Firstly, I am not aware of any precedence of an MD not being involved in such a large and important study, and secondly, the study needs to be considered valid by the medical community.

Thank you for this opportunity to comment on our national healthcare.

Sincerely,
Grace S. Ouchida, L.Ac.
Doctoral Candidate, Pacific College of Oriental Medicine, 2020

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The proposed document would allow certain non-acupuncturists to provide acupuncture services, which defeats the purpose of even calling it acupuncture. Acupuncturists set other healthcare practitioners apart because of our unique diagnosis and treatment methods. To an allopathic-trained professional, acupuncture is not well understood and the use of acupuncture methods may or may not have the efficacy that results from acupuncture applied according to it's original theory.

The document also excluded California licensed acupuncturists who have not also been certified by the NCCAOM. This is an unnecessary step, as the national certifying body is not essential to the efficacious practice of acupuncture certified by the state wherein the acupuncturist practices.

The document labeled licensed acupuncturists as "auxiliary personnel", and it initiated support for supervision of acupuncturists by physician assistants, nurse practitioners and/or clinical nurse specialists.As stated earlier, these requirements are unnecessary for the validation of proof that acupuncture is efficacious.

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First, we are grateful to the CMS for conducting a clinic trial investigating acupuncture’s effectiveness to treat chronic low back pain in geriatric patients. We understand the need that federal health care legislators seek further evidence for the effectiveness of acupuncture in order to justify federal coverage with medicare. Despite any previous effective clinical trials involving acupuncture in the past, we understand that it needs to be on their terms and conducted within their system of research. We also would like to acknowledge and support the ASA letter and its points of argument as valid and important points of reflection for the CMS to consider. Furthermore, we would like to shed light on further topics of consideration for the CMS committee members to contemplate.

Traditional Chinese Medicine (TCM) has been an empirical based medicine for over 3,000 years in China. Acupuncture is one tool out of many for a doctor practicing TCM. The theories and etiologies of TCM are the foundation for formulating a diagnosis and treatment. Selecting specific acupuncture points, how to combine them in a treatment and how to manipulate them are based off of the theories and etiologies rooted in TCM. Acupuncture greatly depends on the quality of TCM education the practitioner received, their clinic experience treating patients and the effective results with their modalities of treatment utilized. Effective acupuncture cannot be learned solely in a weekend seminar or via adjunct CEU courses. Furthermore, one cannot obtain the same level of effective results as a qualified TCM practitioner if one is to approach TCM from any other medical frame of mind.

Regarding the specific topic of chronic low back pain in geriatric patients, it is important to first explain that there are several categories to describe and treat this condition from the point of view of TCM. Firstly, western medical etiologies describe low back pain by structure such as muscular tissue damage, bone damage, ligament damage or nerve damage. Causes of pathology may be described as due to old age, inflammation, trauma, bone degeneration, etc. or entirely idiopathic. While at the same time TCM understands these same problems and treats them, there is a different understanding as to the description of the etiologies and pathologies, why these pathologies occur and how to approach treatment. In TCM there is never an idiopathic diagnosis.

Here listed, are brief examples of different TCM etiologies and pathologies for low back pain. Typically, a two step treatment protocol is involved, treating the branch (i.e. pain symptoms) and then addressing the root cause (i.e. bone degeneration or poor blood circulation). TCM nomenclature describes a unique understanding of pathophysiological functions in the body and are how they are utilized.

Pain that presents “horizontally” across the lower back - this is due to the concept of kidney yang and kidney yin deficiency or due to the overuse of the kidney’s energy, which in turn depletes the kidney from its normal function (i.e. due to high sexual activity).

Pain that presents “vertically” following the lumbar vertebrae - this may include old injuries due to trauma from sports, an accident or previous surgical interventions. (i.e. scar tissue, bone degeneration, bulging discs) Pain that presents both vertically and horizontally is due to pathological temperature abnormalities in the body, particularly cold & damp. Local climates play a role in this type of pathology (i.e. living in northern climates). It is the goal of the TCM practitioner to stop pain symptoms and then proceed to resolve the underlying pathology. If the techniques of acupuncture are not effective enough then it becomes impossible to stop the pain and move on to treat the root cause. A nurse practitioner, physician assistant, M.D., or physical therapist do not possess the understanding or skills of TCM in order to effectively treat a patient with acupuncture in order to resolve pathology, unless they have gone through proper education and training in the theories, etiologies and treatment protocols of TCM. This is required for any other medical practitioner to yield effective results.

As for the selection of representatives of the acupuncture industry for clinical testing, including participants in the design and implementation process, criteria can not solely fall under the qualifications set forth by the NCCAOM (National Certification Commission for Acupuncture and Oriental Medicine). This would exclude practitioners licensed in the states of California and Nevada, who exceed those qualifications of the NCCAOM standards. This is a significant exclusion due to the fact that California acupuncturists represent approx. 40% of registered practitioners in the U.S.

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It is wonderful that CMS has chosen tostudy the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a a Board Certified and Licensed Acupuncturist (L.Ac.) meeting the criteria listed below::

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

I request that the proceeding language of “Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements...” be adjusted so that Licensed Acupuncturist are listed in this list, rather than including the main profession of acupuncture under the title of “auxiliary personnel”. As a profession who has studied many years and maintains high standards of care to practice it is important that LIcensed Acupuncturists are named in this statement and throughout the documents.

This language creates a number of problems and is not consistent with existing law in most places. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.

1 The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

I ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Another statement that is confusing and not reflecting the reality of practicing professional acupuncturists across the country is that we are not supervised by any other profession. So the statement below may apply to this specific trial, however this is not consistent with state laws governing acupuncture by Licensed Acupuncturists. I hope that CMS will respect and remember that Licensed Acupuncturists are already a professional group providing services and are governed by State laws.

“Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist”

While I understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. I ask that this portion be revised.

Thank you for the opportunity to comment and your consideration.

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Dear Sir/Madam,

I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As many Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

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Thank you very much for considering this topic! I treat people of all ages for pain with acupuncture, with great success. I welcome this opportunity for study of acupuncture’s effectiveness in treating pain. Acupuncture has been treating pain effectively for thousands of years. In fact, there are many published scientific studies available through NIH and PubMed already. A few years ago I did a review of the research into acupuncture and compiled some of it, drawing upon studies that had good controls, were reproducible, and which pertained to common pain and disease conditions. I published this in a book about acupuncture entitled, “Acupuncture Revolution: The Science And Healing Power Of Acupuncture.”

I treat pain patients of all ages and help relieve them of their pain. The idea that Medicare would recognize the value of acupuncture in pain relief is exciting.

I would like to request that the section that includes “auxiliary providers” be changed to more precisely name “Licensed Acupuncturists or state equivalent.” The qualifications for auxiliary providers exactly describe this licensure group.

In the state of Florida where I practice acupuncture, four years of education are required before becoming eligible to sit for the National Board Exams (NCCAOM), and in Florida acupuncturists are qualified as primary care providers and go by the appellation, “Acupuncture Physician.” I would suggest that the supervision required during the study portion be done only by an MD. Supervision by other licensure types does not have a precedent and does not add in any way to the safety and quality of the trials.

In any research endeavor, drawing upon the training, licensure, and expertise of a specific profession will add to the quality of work. Please help to make this study as expert, effective and precise as it can be by drawing on the most highly educated and skilled in the practice of acupuncture: Licensed Acupuncturists. We must not settle for anything less.

Thank you!

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I wish to take a moment to thank the CMS for their consideration of this topic. This represents a massive step towards the incorporation of acupuncture into national health care, which I believe to be an important and effective aspect currently not utilized.

I would like to ask that the section that includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describe this licensure group already but without specific titles being mentioned, there is likely to be unintended dis-inclusion.

Our state(MN) already requires robust training at or above the national standards for the practice of acupuncture. We are not only nationally certified but licensed through the board of medical practice after exhaustive training at a masters or doctoral level minimum. We practice on our own without the need for supervision or direct referral from an MD but also within hospitals and other healthcare settings in collaboration with them.

I would like to ask that the supervision required during the study portion be done only by an MD. Supervision by other licensure types does not have a precedent, nor does it add in any way to the safety or quality of the trials.

Overall this is is a very good thing that you are doing, but it is critical that the research include work being done by L.Acs (Licensed acupuncturists) as they are the primary providers of this service in the United States by an overwhelming majority and would have the most experience applicable to the care you seek to study.

A few points and a Summary of Current Research and Medical Standards Supporting Acupuncture:
A comprehensive study commissioned by the Department of Veterans Affairs found acupuncture to have a positive effect in the treatment chronic pain, migraine and tension headache.
The same study found a potentially positive effect in dysmenorrhea, cancer pain, labor pain, insomnia, post-operative nausea and vomit, depression, and smoking cessation.
Acupuncture outperforms placebo in relieving the most common types of chronic pain: headache, low back, neck, shoulder and knee pain.
Acupuncture significantly outperforms standard care in headache, low back, neck, and knee pain.
Acupuncture is superior to most forms of physical therapy in the treatment of knee osteoarthritis.
Acupuncture can reduce the risk of nausea and vomiting after surgery, with minimal side effects.
In a prospective study involving 229,230 patients, acupuncture was found to be a relatively safe treatment with a low risk of serious side effects.
The American College of Physicians recommends acupuncture as a first-line treatment for acute, subacute, and chronic low back pain.
The American College of Chest Physicians recommends acupuncture for cancer patients when pain, nausea, vomiting, or other side effects of chemotherapy are poorly controlled.
The Joint Commission includes acupuncture as one of the non-pharmacological strategies that has a role in pain management in hospitals, nursing homes, and outpatient care.
The FDA’s 2017 Draft Revisions for Prescriber Education for Extended-Release and Long-Acting Opioids states that acupuncture “can play an important role in managing pain, particularly musculoskeletal pain and chronic pain”.

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Greetings,

I am a licensed acupuncturist in the state of Oregon, practicing since 2009, after I completed the required 4-year graduate program in Acupuncture and Oriental Medicine. This was the entry-level required amount of training to be licensed in the U.S. Upon graduation, I had completed 8 years of college-level education. I just completed a 2-year doctorate degree in Acupuncture and Oriental Medicine, and now have a specialization in treating Aging Populations and Women's Health.

I am writting to you now in regards to the Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N). First of all, I would like to thank you for the recognition of the studied and proven efficacy of acupuncture for low back pain, among many other pain-related conditions. In the current time of our opioid crisis, it is vital that citizens have access to quality and effective alternatives to powerfully addictive pain medications for relief from debilitating pain. The current language of this proposal creates numerous problems for the public and current acupuncture providers. It is understandable that this issue may require significant consideration; it is complex and takes familiarization to fully apprehend. The text of greatest concern and relevance is the part about "and auxiliary personnel":

It is in the best interest of the public health that the practitioners who are administering acupuncture are the most highly trained in that specialization. I hear all the time form colleagues throughout the country who are discriminated against by insurance companies, which will allow other medical practitioners to provide acupuncture for reimbursement, but not acupuncturists themselves, who are without a doubt the most well trained and able to provide effective therapy. This is, according to the Provision 2706 of the Affordable Care Act, illegal, as this act requires parity among licensed medical providers. It is vital that the language set forth that will dictate the law of the land state explicitly that the training of those providing acupuncture be more than adequate to ensure not only efficacy of a complex medical treatment within a well established foundational medical model, but safe and not painful or traumatic for for pateints. This is the language we propose:

"We propose alternate language for this section in toto that simply reads:

August 14, 2019

Via Electronic Submission

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd., Mail Stop S3-02-01
Baltimore, MD 21244-1850

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Ms. Syrek Jensen,

On behalf of the Medical Device Manufacturers Association (MDMA), a national trade association representing hundreds of innovative companies in the field of medical technology, I am writing to provide MDMA’s comments regarding the Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N). MDMA is supportive of a comprehensive, multi-modal approach to pain management. We have expressed this support numerous times to representatives from the Department of Health and Human Services (HHS), CMS, Members of Congress and other policy makers. In fact, we supported recommendations from the HHS Pain Management Best Practices Inter-Agency Task Force that recognized the need for a multi-modal approach to pain management and acknowledged the need for patients to have access to a number of treatment options including acupuncture as well as medical device enabled interventions. We respectfully request that CMS also consider how its coverage policies could be revised to improve access to FDA approved or cleared medical devices indicated to treat chronic back pain.

MDMA provides educational and advocacy assistance to innovative and entrepreneurial medical technology companies, and it is our mission to ensure that patients have timely access to safe and effective medical products that improve health outcomes. Our members, the majority of which are small to mid-sized, research driven medical device companies, have a strong record of delivering innovative therapies to patients suffering from chronic diseases and life-threatening conditions while lowering the cost of care. Many of these medical device technologies can help patients suffering from a number of painful symptoms, including chronic low back pain, through non-invasive, minimally-invasive and other procedures.

In announcing this proposal, HHS Secretary Alex Azar said, “Today’s proposal represents the Trump Administration’s commitment to providing Americans with access to a wide array of options to support their health…Defeating our country’s epidemic of opioid addiction requires identifying all possible ways to treat the very real problem of chronic pain, and this proposal would provide patients with new options while expanding our scientific understanding of alternative approaches to pain.” Unfortunately, many pain patients are currently denied access to alternative approaches, like medical devices, due to coverage and payment policies that do not cover or adequately cover the cost of the technology used in a procedure. We respectfully request that CMS consider ways to revise coverage policies to improve access to FDA approved or cleared medical devices indicated to treat chronic back pain.

While former Food and Drug Administration (FDA) Commissioner Gottlieb has stated before Congress that there are over 200 medical devices approved or cleared to treat pain, sadly existing coverage and payment policies deny patients access to many of these non-opioid, non-pharmacological treatments and disincentivize against broader provider adoption. Recent comments in the proposed rule to the calendar year (CY) 2020 Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system indicate that CMS does not believe there is enough evidence to review OPPS/ASC payments for incentives against non-opioid alternatives. We respectfully disagree with this assessment. As you know, true patient access is only realized when each of the three stools in the reimbursement process – coding, coverage and payment – are aligned. The payment challenges are exacerbated by a lack of coverage, which is often referred to as the “valley of death” for medical technology innovation. This is the time between FDA approval or clearance and establishing appropriate and adequate reimbursement with CMS. For large companies, the delay is impactful; however, for many of the small companies that MDMA represents, it is an existential threat.

We are aware of companies that have obtained FDA 510(k) clearance for the treatment of chronic low back pain with compelling evidence to support efficacy, and the patient population they serve would benefit from expanding the proposed decision memo to include their technology, as well as similar technologies and treatment options. Their clearance included multi-site, double-blinded clinical studies and demonstrated significant reduction in patient pain. Longer term tracking indicates continued reduction in patient pain. The low-level laser based procedure is non-invasive with no known side effects. This is just one example of the many medical device enabled interventions that can help patients suffering from chronic low back pain. MDMA respectfully requests that CMS works to expand access to include additional non-opioid alternatives of a similar risk-class by revising coverage policies to improve access to FDA approved or cleared medical devices indicated to treat chronic back pain.

Thank you for the opportunity to provide our comments. I would welcome an opportunity to discuss this issue with you further. Please feel free to contact me by phone at (202) 354-7171.

Sincerely,
Mark B. Leahey
President & CEO, MDMA

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[PHI Redacted] I want to thank the CMS for your consideration of this important topic if adding acupuncture to Medicare so more Americans can receive it's benefits.

However, in reading how the CMS proposes to investigate acupuncture here are a few recommendations:

1. The section that includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describe this licensure group.
2. I also ask that the supervision required during the study portion be done only by an MD as others do not have the proper training and it is unnecessary.

Thank you for you time,

Regards,
MVB

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I have some significant concerns about this proposal as follows:

The proposed document would allow certain non-acupuncturists to provide acupuncture services. Only Licensed acupuncturists in good standing (or those who've completed their Masters of Science in Oriental Medicine, including clinic hour requirements) should be allowed to practice acupuncture.

• It excludes California licensed acupuncturists who have not also been certified by the NCCAOM. The CALE (California Acupuncture Licensing Exam) and the NCCAOM testing requirements have been deemed equivalent.
• It labels licensed acupuncturists as "auxiliary personnel". This wouldn't fly with Chiropractors, Physical Therapists or any other profession, why is it okay here?

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As an licensed Acupuncturist for 19 years. Thank CMS for your consideration of this topic that study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare.

i am seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹

The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE).³ We propose alternate language for this section in toto that simply reads:

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California licensees represent nearly one-third of all licensed acupuncturists (LAcs) in the USA. Along with other relevant stakeholders who will be affected by the decisions made based on the outcomes of these planned studies, we are concerned about problems created by the language of the proposed decision memo and inconsistencies with existing law. We are seeking clarification on several issues as outlined below.

While 2,147 licensed California acupuncturists are additionally certified by the NCCAOM, current state law does not require NCCAOM certification for licensure or practice, nor does it require supervision by an MD. The California Acupuncture Licensing Exam (CALE) has been certified to be equivalent to the NCCAOM certification exams by the NCCAOM itself, following extensive independent authentication. Our current educational requirement of 3,000 hours of didactic and clinical training exceed the minimum NCCAOM requirements as adopted by 47 states and District of Columbia. Although California has more licensed acupuncturists than any other state, more required training than most other states, and certified exam equivalency, the current framing excludes 10,038 qualified active California licensed acupuncturists while creating ambiguity with use of the term “auxiliary personnel” in its proposed decision memo.

CMS for its consideration of this topic which represents an important step towards the incorporation of acupuncture into national health care.

• Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:
  • A masters or doctoral level degree in acupuncture or Oriental Medicine o from a school accredited by the Accreditation Commission on
  • AcupunctureandOrientalMedicine(ACAOM);
  • a current certification by the National Certification Commission for
  • AcupunctureandOrientalMedicine(NCCAOM);and
  • maintained licensure in a U.S. state or territory to practice acupuncture.

we propose alternate language for this section in toto as follows:

• Licensed acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

We strongly object to the term “auxiliary personnel” as the default term for licensed acupuncturists, who have obtained the unique Bureau of Labor Statistics (BLS) designation 29-1199.01 Acupuncturist, especially since we collectively have more training in this specialty than any other designation. We request that the term “licensed acupuncturists” be used and included, where appropriate, in all data collected and reported from these studies and in all documentation related to recruiting, study methods, and other coverage based on the outcomes of the studies requested by CMS, so that those decisions should be based on the actual provision of care which would include not only the number of treatments and the techniques prescribed, but also the training, licensure and proper designation of the State laws and regulations designate our LAcs as primary healthcare physicians in the arena of Workers Compensation4 in Labor Code Division 4 §3209.3 5and specifically allow acupuncturists to practice autonomously as independent providers without direct or indirect supervision by an MD or any other supervisor. Only five designated licensures are permitted to practice acupuncture in California: LAcs, physicians and surgeons (without additional certification), and dentists and podiatrists who have also completed a certification course in acupuncture6. All other licensures are prohibited from practicing acupuncture unless they also hold an acupuncture license. This prohibition includes Physical Therapists, Physician Assistants, nurse practitioners, and clinical nurse specialists. State law also specifically prohibits supervision of acupuncturists by physicians, dentists, or podiatrists for training or tutorial purposes unless they are also a licensed acupuncturist. Thus, the use of “auxiliary providers” seems to attempt to allow participation by providers who would not otherwise qualify for inclusion unless they were already LAcs, while excluding 10,038 qualified LAcs who have met and/or exceeded licensing and education standards in California. This represents an exclusion of about 26% of all eligible, qualified acupuncturists in the USA. Therefore, regarding the following text of the proposed decision memo, as follows:

While we understand the need for direct supervision by a physician during the official research study, it is inconsistent with California state law and with every other state law that licensed acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. As mentioned previously, certain aspects of California law prohibit supervision of acupuncturists by professionals who are not themselves licensed acupuncturists. There is no precedent for the inclusion of these professionals as supervisors of acupuncturists, nor does it improve patient safety, study design or provision, or any other aspect of the validation, assessment, or decision-making process of this effort. Licensed acupuncturists have an outstanding safety profile documented in all states regulating licensure. We ask that the terms “physician assistant” and “nurse practitioner/clinical nurse specialist” be removed in order to revise this portion for consistency with state laws.

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Thank you for considering acupuncture as a potentially effective treatment for chronic low back pain. As a Licensed Acupuncturist, I have worked at several Community Acupuncture clinics across Massachusetts; chronic low back pain is one of the most common reasons people seek acupuncture. I see how much acupuncture improves quality of life for my patients, and appreciate any step toward making this treatment more widely available.

In almost all states, there are already Licensed Acupuncturists providing safe and effective acupuncture treatments. In the state of Massachusetts, where I practice, acupuncturists are licensed by the Board of Registration in Medicine. Licensed Acupuncturists must meet stringent educational requirements and pass board exams administered by the NCCAOM.

With the understanding that supervision of MDs is necessary for a clinical trial, I urge you to consider that there is no precedent for any other medical professionals to supervise Licensed Acupuncturists providing acupuncture treatment. Please amend your section that includes “auxiliary providers” to clearly name “Licensed Acupuncturists or state equivalent”.

As Secretary of the People’s Organization of Community Acupuncture (POCA) I would also like to bring your attention to POCA’s resources: we are a multi-stakeholder cooperative of Community Acupuncture patients, providers, clinics. Community Acupuncture is a model for providing a high volume of acupuncture treatments for a low cost per treatment. More information is available at pocacoop.com

POCA has also supported the first adverse events reporting database for acupuncture, available online at https://acupunctureconsumersafety.net/

Thanks for taking the time to read my comment.

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Thank you for the consideration of this topic. This represents a massive step towards the incorporation of acupuncture into national health care and will help direct patients to acupuncture providers with the proper training necessary to serve this patient population.

Collectively we ask that the section that includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists (LAc), Doctors of Acupuncture (DAOM or DACM) or state equivalent” be included in the language. The qualifications for auxiliary providers exactly describe this licensure group. All others would be considered not qualified.

In California Licensed Acupuncturists(LAc) and Doctors of Acupuncture and Oriental Medicine (DAOM) and Doctors of Acupuncture and Chinese Medicine (DACM) are designated as Primary Care Providers and do not require supervision or a referral from another medical provider. LAcs have over 3000 hours of training, DACMs have 6 months of additional competencies for the designation of "doctor" and DAOMs have an additional 2 year clinical doctorate with advanced clinical skills and background in research. Both DAOMs and DACMs are doctors in the state of CA.

I personally work for an FQHC in California and I see MediCal patients daily for back pain with tremendous success. Patients are very enthusiastic about the treatment and receive pain relief that is not controlled with medication or physical medicine. Acupuncuture provided by an LAc, DAOM or DACM does not require supervision or referral from an MD.

Supervision by other licensure types does not have a precedent, nor does it add in any way to the safety or quality of the trials.

Acupuncture providers allowed to participate in CMS should have a degree from a 4+ year accredited acupuncture program in the United States and be licensed as an LAc, DACM or DAOM. These are the only existing acupuncture degree titles allowable in the state of CA. Other states may have other degree titles such as DOM or Acupuncture Physician.

Thank you for your consideration. Trials of this nature would be a good fit for FQHCs that have already been providing pain management services for back pain using LAc, DAOM and DACMs.

Respectfully, Dr. Gretchen Seitz, DAOM, LAc, Dipl OM, AC, CH

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Mr. Dolan & Dr. Miller,

Thank you for efforts made on behalf of the Centers for Medicare & Medicaid Services (CMS) to study acupuncture for chronic low back pain in Medicare populations. Additionally, thank you for the opportunity to provide acupuncture to Medicare patients who are participating in approved trials.

However, the current language of the Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N) threatens to obstruct significant numbers of licensed acupuncturists from participating in current and future trials.

I jin my colleagues in requisition that the language of the proposed memo be updated:

• to include ‘licensed acupuncturists’
• and remove physician assistants, nurse practitioners/clinical nurse specialists, and auxiliary personnel, since acupuncture/dry needling are not within their scopes of practice.

Furthermore, it is appropriate to remove requirements for physician supervision. Acupuncture is a licensed profession that is regulated by legislation in 48 states and the District of Columbia.

In order to apply for licensure, the majority of states require that acupuncturists: graduate from an accredited graduate school, pass national or state examinations, and are certified in clean needle technique.

Numerous states require practitioners pass National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) examinations before applying for licensure, and some, but not all require this certification be maintained in order to continue licensure.

The state of California has the largest number of licensed acupuncturists of all of the United States and provides its own examination that is separate from the NCCAOM.

The NCCAOM currently represents 18,105 acupuncturists, but it is estimated that there are approximately 30,000-35,000 licensed acupuncturists in the United States.

I request that the requirement for current NCCAOM certification be removed and replaced with ‘licensed acupuncturist’ so that all qualified licensed acupuncturists can deliver treatment to Medicare recipients. As it stands, not only does this requirement obstruct nearly half of our profession from administering treatment to Medicare recipients, it also obstructs the majority of providers in California.

As determined by statutes and legislation across the nation, licensed acupuncturists have complete autonomy to administer acupuncture and to bill insurance without referral from the patient’s primary medical doctor. I suggest that CMS develop framework that is similar to the US Department of Veterans Affairs (VA). The Standardized Episode of Care (SEOC) coverage defined by the VA allows covered individuals to receive 12 acupuncture sessions from licensed acupuncturists without any prior authorization8, and an additional 8 treatments for chronic conditions upon demonstrating continued improvement from the acupuncture treatment.

The VA acupuncture coverage reimburses licensed acupuncturists, without any prior authorization for CPT codes that are specific to acupuncture (97810, 97811, 97813, 97814) and evaluation and management codes (99201-99205).

Looking forward, to keep acupuncture sustainable, we need to move towards increased reimbursement rates at a 10% rate annually for the above CPT codes for both Medicaid and Medicare.

Moving to cover acupuncture for Medicare patients with chronic low back pain represents a great accomplishment for patients looking to receive safe alternatives for pain management, and for practitioners who deserve to be reimbursed for their work.

Thank you for considering our suggestions to ensure that licensed acupuncturists are correctly represented moving forward, and thank you for all of your work on this project thus far.

Sincerely,
Janet L. Borges, MSTCM, Dipl. A.C & C. H. (NCCAOM), L.Ac.

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August 14, 2019

We appreciate the opportunity to respond to the Proposed Decision Memo regarding acupuncture for chronic low back pain (cLBP).

We first would like to ask for the CMS to correct how it classified the Acupuncture Now Foundation (ANF) in the Proposed Decision Memo. You indicated the ANF was one of several “professional associations” who offered comments. The ANF is not a professional association. We are a public benefit educational non-profit (501c3). Our work focuses on benefiting the public, not the acupuncture profession.

As an organization with the goal of serving the interest of the public, we are concerned by the decision proposed in this memo, as it appears to be at odds with that goal. The opioid crisis is the worst public health epidemic of modern time, wreaking havoc on millions of people and entire communities. It is also a unique epidemic in that it resulted from a tragic failing by key decision-makers to accurately evaluate the benefit-to-harm ratio of a pain management therapy.

The CMS decision-makers now have an opportunity to support the use of a therapy that its own research found to have a much better benefit-to-harm ratio. After months of compiling and evaluating the most recent evidence on acupuncture for cLBP, the CMS’ research uncovered a surprisingly high number of systematic reviews/meta-analyses. All eight of these studies were published within the last five years and met CMS’ inclusion criteria. Systematic reviews and meta-analyses are high-level research evidence. All eight studies found acupuncture to be effective for cLBP, with some of them verifying acupuncture’s excellent safety record, and one endorsing its cost effectiveness. Yet, despite such sound evidence, the CMS is proposing that this is not evidence enough because none of the reviews specifically targeted Medicare-aged subjects.

Some of the studies reviewed by the CMS reported subjects with an average age of up to 59 years. The CMS did not offer, nor were we able to uncover, any scientific evidence or rationale suggesting that acupuncture found to be effective on adults in their 50s would not be effective for those aged 65 and over. Those of us who practice acupuncture on Medicare-aged patients observe little to no change in the level of effectiveness between adult age groups.

Adding to the urgency to expand third-party coverage for acupuncture is the fact that several U.S. evidence-based medical guidelines now recommend acupuncture for chronic pain conditions, including cLBP, but physicians complain that they cannot follow those guidelines due to their patients’ lack of insurance coverage for non-drug therapies like acupuncture. In 2017, 37-State Attorney Generals signed a letter to a health insurance lobbying group imploring to expand coverage for non-drug therapies, including acupuncture, to help combat the opioid crisis. Considering Medicare has never covered acupuncture, they could have just as well have addressed that letter to the CMS.

In a July 24th 2019 Washington Post editorial, CMS Administrator Seema Verma wrote about how slow Medicare coverage policies are to adopt new innovations, saying: “The result is innovation stagnation and limited access to new treatments. The president’s budget includes several proposals that attempt to address this.”

We trust the CMS is sincere in its goal to do all it can to combat the opioid epidemic and understand that doing something as innovative as approving acupuncture for the first time may meet with the innovation stagnation Administrator Verma complained of. While it would be preferable in a perfect world for the CMS to have research that targeted Medicare-aged patients, the world of pain management in the age of the opioid crisis is far from perfect. Considering that cLBP is the top reason why Medicare patients are prescribed opioids, that physicians are being put in a position where they may not be able to follow guidelines recommending acupuncture, and that the CMS has researched eight systematic reviews/meta-analyses all with positive findings, we hope this would prompt the CMS to find a way to confront this stagnation and avoid making Medicare cLBP patients wait years for the results of new studies with no guarantee of coverage even then.

We also hope CMS will be clearer in acknowledging that the studies it already reviewed constitute a strong body of evidence showing that acupuncture is effective for cLBP and that the statement CMS made in the proposed decision memo referring to the evidence as “promising but not convincing” is referring only to Medicare-aged patients. We ask this because acupuncture is constantly questioned by a small group of critics often quoted in the media who claim that its positive clinical results are due to the placebo effect, even though the latest evidence shows otherwise. If the CMS made it clear that the evidence it complied and reviewed was convincing for the adult age groups under 65 years of age, it would help those of us who advocate for the expanded use of acupuncture and its third-party coverage based on the latest evidence.

Opioids kill, acupuncture does not. While this proposed delay goes on, Medicare will continue to cover the cost of opioids and other risky drugs, but not acupuncture. For these reasons, we believe CMS’ decision to at least delay approving coverage for acupuncture for cLBP is a sign of misplaced priorities and we ask CMS to reconsider this proposal.

Our Suggestions and Questions.

We urge CMS to find a way to accept the evidence it already has as sufficient to classify acupuncture for cLBP as medically necessary, even if it is a provisional approval until other studies can be carried out. The state of Missouri is currently taking this approach to curb the opioid crisis, i.e. providing coverage for acupuncture and other non-drug therapies to the state’s Medicaid population diagnosed with chronic pain while additional studies are ongoing. https://dss.mo.gov/mhd/providers/education/files/2019-Complementary-Alternative-Therapy-Training.pdf

If the CMS determines that there is no other path toward approval except collecting data specific to Medicare-aged patients, it could try conducting an individual patient data meta-analysis using raw patient-specific data from the eight trials recently reviewed. This would help CMS understand how many patients of Medicare age were in those trials and what the outcomes among them were. This would be less time-consuming and more cost-effective to complete, as those studies may already provide the additional answers that the CMS seeks regarding Medicare-aged patients.

If the CMS considers it necessary to make cLBP Medicare patients wait on acupuncture coverage until the additional studies are conducted and reviewed, we would like to highlight below some important limitations to the CMS’ trial guidelines that should be carefully considered and addressed to allow for better quality research.

Limited Trials vs. Striving for Maximum Therapeutic Benefit

In the comments the Acupuncture Now Foundation submitted to the CMS on this matter in February, we pointed out that due to a lack of clinical practice guidelines for acupuncture practice, many acupuncture studies are conducted in a way that does not allow acupuncture to reach its maximum therapeutic benefit (MTB). There are no trial reporting guidelines (including those in STRICTA) that require researchers to state if their study was attempting to achieve acupuncture’s MTB or if it was designed to only investigate a limited application of acupuncture. While limited-application studies have their place within research, they would not be appropriate for answering the questions the CMS is trying to answer around the effectiveness of acupuncture on Medicare-aged patients suffering from cLBP.

There are two main factors that differentiate studies investigating a limited application of acupuncture from those attempting to achieve MBT. The first is that limited-application studies do not allow for an optimal dosage of acupuncture (frequency and total number of treatments). The second is the involvement of “acupuncturists” with limited training. The proposed “covered indications for CMS approved studies” do not adequately address these two challenges, risking the acceptance of trials that are by design unable to effectively measure the full benefits of acupuncture.

While acupuncture done with sub-optimal treatment dosage or by acupuncturists with sub-optimal training could still yield positive benefits, they will not likely be as effective, thus leading to false negatives. As such, the CMS should not use evidence from limited-application trials as the basis to determine whether acupuncture is medically necessary for cLBP.

Acupuncture is Dose Dependent

Just as a drug trial would need to establish the optimal dosage of the drug being studied to investigate its MTB, studies investigating acupuncture’s potential MTB need to establish the adequate dosage of acupuncture. This is achieved through a combination of adequate frequency of treatments over a long enough period of time. CMS is proposing studies utilizing “A minimum 12-week acupuncture intervention”. Although 12 weeks is an acceptable minimum timeframe to study acupuncture for cLBP, we are concerned that there are no requirements for a minimum number of treatments throughout the 12 weeks.

In the CMS’ decision memo on Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N), the CMS seemed to appreciate the importance of therapeutic dosage in specifying Medicare would cover up to 36 sessions over 12 weeks. 36 treatments over 12 weeks would also be a reasonable protocol for acupuncture treatment frequency for cLBP patients. Although such frequency may appear higher than the average treatment frequency in the U.S., it is cost factors and especially the lack of insurance coverage that limits many patients from getting the optimal number of treatments. In China, where there is socialized medicine, the standard is to start with daily or every other day treatments, and dozens of treatments are often required to achieve MYB when treating chronic conditions like cLBP. At a minimum, we recommend requiring at least two treatments per week for at least 6-8 weeks that could then tapper down to once a week over the next 4-6 weeks.

In our February submission to CMS, we included a section titled “Acupuncture is Dose Dependent”, where we described evidence showing that the effectiveness of acupuncture for chronic conditions increases with more frequent treatments carried out over longer periods of time. We cited references of several acupuncture trials to support this perspective. A good example of a study that utilized an adequate dosage of treatments allowing acupuncture to reach MTB is “ Effectiveness of Acupuncture as Adjunctive Therapy in Osteoarthritis of the Knee A Randomized, Controlled Trial” by Brian M. Berman, MD; Lixing Lao, PhD; Patricia Langenberg, PhD; Wen Lin Lee, PhD; Adele M.K. Gilpin, PhD; and Marc C. Hochberg, MD (Ann Intern Med. 2004;141:901-910).

Training and Qualifications of Acupuncturists Involved in Trails

Guidelines regarding who can perform acupuncture in CMS approved studies are unclear. They do not mention the types of providers who would typically have the highest required level of training and competency testing, i.e. Licensed Acupuncturists. It is also unclear whether CMS will allow this type of providers to take part in the studies if they are not licensed as physician assistants or nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)). CMS makes it clear that it will allow physicians to furnish acupuncture in these studies “in accordance with applicable state requirements.” However, most states do not require physicians to have any training or pass any competency exams in acupuncture. Although STRICTA has a requirement to report the years of experience the participating acupuncturists have, it does not require reporting the acupuncturists’ training.

Given these limitations in the requirements for approved studies, CMS could end up accepting studies that involve physicians with no acupuncture training and result in the application of a limited number of treatments, which are factors not conducive for acupuncture to reach its MTB.

As these studies will be employed to determine whether acupuncture is recognized by CMS as medically necessary, we urge the CMS to address these two major challenges in the study design protocol so as to avoid pre-introducing biases into the research. We specifically ask for CMS to clarify both the minimum number of treatments required to be done over the 12-week timeline and to establish guidelines for ensuring that the acupuncturists providing the treatments and developing the clinical protocols in these studies are well trained. The ANF would be happy to work with CMS to improve these protocols.

More on Acupuncturists’ Training and Legal Status

We understand that the laws regarding what types of providers can legally practice acupuncture vary from state to state. We also can appreciate that your standards for who can administer acupuncture in these studies may get even more complicated due to Medicare billing requirements. However, there is a real concern among acupuncture providers that the manner in which CMS describes what types of providers will be allowed to perform acupuncture in these studies may disqualify Licensed Acupuncturists as a type of provider who could bill for those services, even in the event of CMS eventually approving the procedure of acupuncture for Medicare coverage.

CMS states that “Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.” It seems the “auxiliary personnel” could be a “Licensed Acupuncturist”, although this is not explicit. The vast majority of acupuncture treatments carried out in the U.S. are performed by Licensed Acupuncturists in private practice or in small clinic settings where there is no direct supervision by physicians, physician assistants, or nurse practitioners/clinical nurse specialists. If CMS’ current guidelines on who can perform acupuncture in these trials are also being used to test how acupuncture providers could eventually bill Medicare for that procedure, we ask that CMS gives careful consideration to this point. By requiring direct supervision by someone with no required training in acupuncture, CMS is greatly limiting the pool of the most experienced acupuncturists who could potentially participate in these studies and eventually treat and bill under Medicare.

Questions we ask CMS to address:

It is our understanding that CMS will respond to public input and so we ask that you please respond to the following:

We thank you for the opportunity to provide comments on this important policy decision process and we again offer our expertise to support you with this or any further NCAs on acupuncture.

Matthew Bauer, L.Ac.
President, The Acupuncture Now Foundation
mbauer@acunow.org

John McDonald, B.H.Sc(Ac), M.Ac, Phd, FAACMA
Vice President, The Acupuncture Now Foundation
President, The Acupuncture Now Foundation Australia

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I am the clinic manager at Wasatch Community Acupuncture, a large non-profit clinic that offers acupuncture on a $15-$40 sliding scale in Salt Lake City, Utah. We are members of the national cooperative called the People's Organization of Community Acupuncture (POCA), which is committed to making acupuncture as accessible and affordable as possible.

Our clinic has been open for over ten years, and we do over 17,000 treatments a year. We have extensive experience in treating people with chronic low back pain.

As with any medicine, acupuncture doesn't work 100% of the time, but it works much of the time and has the potential to change people's quality of life. If access is increased and more people are able to receive acupuncture for things like chronic lower back pain, the need for and use of pain medications will dramatically decrease.

Acupuncture is minimally invasive and inexpensive, making it ideal for chronic issues including lower back pain. Because acupuncture also has a relaxing effect on the nervous system, many patients report a reduction in their stress and anxiety levels. I urge you to include acupuncture as a treatment for lower back pain.

Also, if Medicare/Medicaid should decide cover acupuncture for those with chronic lower back pain, your agency should work with all licensed acupuncturists as providers. If an acupuncturist has a valid state license, then he or she is qualified to perform acupuncture. Please do not limit this only to acupuncture practitioners who maintain national certification with the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM), which is what the Veterans Administration did. Most states require either the NCCAOM board exams or the very similar California or other state exams. There is no difference in the quality of care that comes from acupuncturists who pay to keep their national certification after their boards are completed and those who do not; the same is true for states that use alternatives to the NCCAOM boards.

Thank you for your consideration on this important issue.

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August 14, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Ms. Syrek Jensen and Colleagues:

The National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) appreciates the opportunity to provide comments to the Centers for Medicare and Medicaid Services’ (CMS) Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (cLBP) (CAG-00452N). The NCCAOM applauds CMS’ proposed decision to allow acupuncture services from an NCCAOM Board-Certified Acupuncturist for Medicare beneficiaries participating in sanctioned research to determine acupuncture’s effect on cLBP. Facilitating research among Medicare beneficiaries will help strengthen the evidence base demonstrating acupuncture as an effective, safe, and affordable pain-management option.

The NCCAOM’s comments focus on three major points:

1. The importance of CMS maintaining its requirement that practitioners providing acupuncture hold a current NCCAOM certification.
2. upervision requirements.
3. Evidence demonstrating the efficacy, safety, and cost-effectiveness of acupuncture for cLBP.

As the nation’s only certifying body for acupuncturists, the NCCAOM seeks to ensure the public’s safety and well-being while advancing the professional practice of acupuncture by establishing and promoting national, evidence-supported standards of competence and credentialing. The National Commission for Certifying Agencies accredits the NCCAOM’s three certification programs, making NCCAOM the gold standard for acupuncture certification.

Since its inception in 1982, the NCCAOM has issued more than 25,000 certificates in acupuncture, Oriental medicine, and Chinese herbology. Currently, the NCCAOM certifies 1,200-1,500 acupuncturists annually and represents more than 18,000 nationally certified practitioners.

NCCAOM Diplomates (National Board-Certified Acupuncturists) must recertify every four years to maintain their certifications. Recertification includes 60 hours of Professional Development Activity/continuing education—30 of these hours must include retraining in acupuncture core competencies. Recertifying Diplomates must also complete at least four hours of safety and ethics training, including education on blood-borne pathogens, clean-needle technique, and CPR re-certification. NCCAOM Board-Certified Diplomates must agree and adhere to the NCCAOM Code of Ethics. Diplomates who violate the NCCAOM Code of Ethics may face certification denial, probation, suspension, or revoked certification.

The certification standards Diplomates meet by passing one of the NCCAOM examinations in Foundations of Oriental Medicine, Acupuncture with Point Location, and Biomedicine represent the minimum requirements necessary for acupuncturists to deliver acupuncture safely and competently without physician supervision. The Biomedicine exam, in particular, ensures that the NCCAOM Diplomates have the knowledge to know when to refer a patient to a physician or other healthcare practitioner.

In addition, it allows acupuncturists to communicate effectively with western medical practitioners. To pass the NCCAOM Biomedicine Examination, candidates must demonstrate knowledge, skills, and abilities in referral and safety, uphold professional ethics, and perform practice management in compliance with all federal and state laws.

In recent years, the NCCAOM has worked directly with federal agencies to establish certification programs to verify competency and ensure access to the NCCAOM Diplomates in the federal arena. This includes creating a distinct classification code with the Bureau of Labor Statistics for Acupuncturists, and developing a qualification standard within the Veterans Health Administration (VHA) for acupuncture practitioners, which states that VHA-hired acupuncturists “…must be board certified through the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). The board certification must be current and the acupuncturist must abide by the certifying body's requirements for continuing education.”

NCCAOM Board-Certification requirements do not reduce or inhibit access to acupuncture practitioners—the requirement actually ensures that those furnishing these services have met nationally recognized standards for training, competency, and adherence to safety protocol.

NCCAOM certification is especially critical for acupuncturists because education and training requirements significantly differ among state acupuncturist licensure laws and not all state acupuncturist licensure laws require Board certification. Forty-seven states (and the District of Columbia) have practice acts in place to define and regulate the practice of acupuncture. Of these, 22 require NCCAOM Board Certification for acupuncture licensure. Twenty-six more use NCCAOM examinations as a portion of the licensure requirements. As a result, all states except California require candidates to either pass the NCCAOM examinations or obtain NCCAOM certification.

In fact, NCCAOM Diplomates practice across the country including the three unregulated states: Alabama, Oklahoma and South Dakota. As written, the decision memo would exclude those acupuncturists in these states, and the NCCAOM suggests that CMS waive the state licensure requirement for the states where licensure is not available.

California, which has its own licensing exam, has over 3,800 NCCAOM-Certified Acupuncturists, as many California acupuncturists choose to become NCCAOM certified. California-licensed acupuncturists can also apply for NCCAOM certification under a time-limited route after demonstrating good standing under California licensure and other requirements (for details visit: https://www.nccaom.org/certification/california-route/). California created this route after performing an exam audit and equivalency study, which resulted in the California Acupuncture Board recommending legislation requiring the NCCAOM exams in California.

The NCCAOM stands by the NCCAOM Board-Certification process and its examinations as they demonstrate achievement, safety, quality, and competence in the practice of acupuncture. The NCCAOM’s state-level work continues to help improve state licensure requirements to protect patients across the country, and the NCCAOM works closely with state governments to provide information and support for any developments with acupuncture practice acts.

It is important that CMS recognize National Board Certification as a method for ensuring competency standards, adequate training, and patient safety. As noted above, three states currently do not license acupuncturists, which presents major quality and patient-safety issues—and makes Board certification essential. As such, the requirement that those providing acupuncture services be NCCAOM-certified is critical to ensuring competence and Medicare beneficiaries’ safety.

The NCCAOM notes that the proposed decision memo includes a provision that acupuncturists deliver services as auxiliary personal under “direct supervision.” The challenge is that the majority of board-certified acupuncturists do not practice under any sort of physician supervision. They are in private practice. Most physicians do not have any acupuncture training and do not have the qualifications to supervise from a patient-safety perspective. Physicians who have training are usually NCCAOM Board Certified. The NCCAOM suggests that if CMS has to have a supervision requirement, CMS define it as “general supervision.”

In fact, acupuncturists qualified under the proposal should have the capacity to be principal investigators (PI) on studies to ensure the studies are well constructed. In the past, research efforts have wasted significant resources on poorly constructed studies by PIs with limited understanding of acupuncture as a medicine and not just the placement of needles.

The body of evidence showing acupuncture’s efficacy for cLBP continues to grow. The following studies specifically pertain to acupuncture for CLBP:

1. Brinkhaus B, Witt CM, Jena S, et al. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med. 2006 Feb 27; 166(4):450-7. Doi: 10.1001/archinte.166.4.450. PMID: 16505266.
2. Brinkhaus B, Witt CM, Jena S, et al. Interventions and physician characteristics in a randomized multicenter trial of acupuncture in patients with low-back pain. J Altern Complement Med. 2006 Sep;12(7):649-57. doi: 10.1089/acm.2006.12/649. PMID: 16970535.
3. Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, et al. AHRQ Comparative Effectiveness Reviews. Noninvasive Treatments for Low Back Pain. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016.
4. Furlan AD, Yazdi F, Tsertsvadze A, et al. A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain. Evid Based Complement Alternat Med. 2012;2012:953139.
5. Gao H, Wei C. Extra point acupuncture treatment of 36 cases of acute lumbar sprain [in Chinese]. Journal of Gansu College of Traditional Chinese Medicine. 2006;2006:49-50.
6. Haake M, Muller HH, Schade-Brittinger C, et al. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007 Sep 24;167(17):1892-8. doi: 10.1001/archinte.167.17.1892. PMID: 17893311.
7. Hasegawa TM, Baptista AS, de Souza MC, Yoshizumi AM, Natour J. Acupuncture for acute non-specific low back pain: a randomised, controlled, double-blind, placebo trial. Acupunct Med. 2014;32:109-15. [PMID: 24316509] doi:10.1136/acupmed-2013-010333.
8. Jin M, Chen J. Acupuncture treatment for 40 cases of acute lumbar sprain [in Chinese]. Journal of Gansu College of Traditional Chinese Medicine. 2008;2006:49-50.
9. Lam M, Galvin R, Curry P. Effectiveness of acupuncture for nonspecific chronic low back pain: a systematic review and meta-analysis. Spine (Phila Pa 1976). 2013 Nov 15;38(24):2124-38.
10. Lan J. Analysis of application of acupuncture analgesia in acute lumbar sprain [in Chinese]. Journal of Community Medicine. 2009:68-9.
11. Lee JH, Choi TY, Lee MS, Lee H, Shin BC, Lee H. Acupuncture for acute low back pain: a systematic review. Clin J Pain. 2013;29:172-85. [PMID: 23269281] doi:10.1097/AJP.0b013e31824909f9.
12. Liu L, Skinner M, McDonough S, Mabire L, Baxter GD. Acupuncture for low back pain: an overview of systematic reviews. Evid Based Complement Alternat Med. 2015;2015:328196.
13. Montes LA, Valenzuela MJ. Effectiveness of low back pain treatment with acupuncture [in Spanish]. Biomedica. 2017 Jun 2;38(0);54-60. Doi:10.7705/biomedical.v38i0.3546. PMID: 29809328.
14. Standaert CJ, Friedly J, Erwin MW, et al. Comparative effectiveness of exercise, acupuncture, and spinal manipulation for low back pain. Spine (Phila Pa 1976). Oct 1 2011;36(21 Suppl):S120-130.
15. Thomas KJ, MacPherson H, Thorpe L, et al. Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ. 2006 Sep 23;333(7569):623. doi: 10.1136/bmj.38878.907361.7C. PMID: 16980316.
16. Vas J, Aranda JM, Modesto M, Benitez-Parejo N, Herrera A, Martinez-Barquin DM, et al. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial. Pain. 2012;153:1883-9. [PMID: 22770838] doi:10.1016/j.pain.2012.05.033
17. Wellington J. Noninvasive and alternative management of chronic low back pain (efficacy and outcomes). Neuromodulation. 2014 Oct;17 Suppl 2:24-30.

Additional studies show that acupuncture is an effective pain-management option for chronic pain:

• In 2017, Vickers et al., updated their 2012 meta-analysis of acupuncture research to include trials published through 2015. The research analyzed data from 39 trials and 20,827 patients to show that acupuncture was more effective than both the sham and no acupuncture controls for each pain condition (all P?1
• In Germany, a large-scale observational study examined 454,920 patients diagnosed with one or more sources of chronic-pain, including cLBP (45 percent of patients), headache (36 percent), and osteoarthritis (12 percent), who received acupuncture. Physicians rated acupuncture’s effectiveness in 22 percent of the patients as marked, 54 percent as moderate, 16 percent as minimal, and 4 percent as poor (unchanged).²
• Another German study involving 340 outpatient acupuncture practices and 1,162 patients with a mean of eight years of cLBP, received 10 treatments over a five-week period. The patients’ back pain reduced for more than six months post treatment, and the acupuncture effectiveness was almost twice that of conventional therapy.³

The American College of Physicians cites acupuncture as one of the strongly recommended treatments for back pain in guidelines published⁴ and a number of national and state agencies. A Birch, et al. article states:

“The Acupuncture Evidence Project” recently published a summary of the current evidence for acupuncture and used the GRADE evidence framework to conclude the following:

• Chronic Pain: The effect of a treatment course of acupuncture for individuals with chronic pain appears to persist over 12 months and that such a treatment course is cost-effective.
• cLBP: Moderate-to-high quality evidence for acupuncture’s effectiveness, cost-effectiveness, and safety exists for individuals with cLBP.⁶

The Department of Veterans Affairs’ Evidence Map of Acupuncture for Pain (final page Figure 1), examined all available systematic reviews and randomized-controlled trials and concluded that acupuncture had a “positive effect” on chronic pain, based on recent systematic reviews and randomized-controlled trials.⁷

When performed by properly trained and certified practitioners, acupuncture is widely recognized to be a safe, frequently effective, non-pharmacological option for treating chronic and acute pain syndromes. A 2017 Chan, et al. systematic review concluded that while some adverse events are reported, “all the reviews have suggested that adverse events are rare and often minor.”⁸ Other studies support these findings.^9,10,11

Other countries have documented cases of severe adverse events such as pierced brainstems, spinal lesions, transmitted infectious disease, punctured organs, broken needle migration, and death. These events may be associated with inadequate practitioner competence and training, which sufficient standardized regulations (e.g. NCCAOM certification) can help prevent. The following studies address safety and adverse events with acupuncture treatment:

1. Given, S., “Clean Needle Technique Manual for Acupuncturists: Guidelines and Standards for the Clean and Safe Practice of Acupuncture, 6th Edition,” National Acupuncture Foundation: Nov 2009.
2. Guerreiro de Silva, JB., Saidah, R., Megid, CB., Ramos, NA., “Adverse events following acupuncture: a prospective survey of 13,884 consultations in a university outpatient acupuncture training clinic in Brazil,” European Journal of Integrative Medicine. Vol. 6, Aug 2014.
3. Jaung-Geng Lin, Yi-Hung Chen, Xin-Yan Gao, Lixing Hao, Hyejung Lee, and Gerhard Litscher, “Clinical Efficacy, Mechanisms, and Safety of Acupuncture and Moxibustion,” Evidence-Based Complementary and Alternative Medicine, vol. 2014, Article ID 356258, 2 pages, 2014.
4. Kim, Me-Riong et al. “Safety of Acupuncture and Pharmacupuncture in 80,523 Musculoskeletal Disorder Patients: A Retrospective Review of Internal Safety Inspection and Electronic Medical Records.” Ed. Romy Lauche. Medicine 95.18 (2016): e3635. PMC. Web. 17 Nov. 2017.
5. Kim, YJ., Kim, SK., Cho, SY., Park, SU., Jung, WS., Moon, SK., Ko, CN., Cho, KH., Kim, SB., Shin WC., Park, JM., “Safety of acupuncture treatments for patients taking warfarin or antiplatelet medications: Retrospective chart review study,” European Journal of Integrative Medicine, Vol. 6, Aug 2014.
6. Lao, Lixing; Hamilton, Gayle R; Fu, Jianping; Berman, Brian M. “Is Acupuncture Safe? A Systematic Review of Case Reports.” Alternative Therapies in Health and Medicine; Aliso Viejo Vol. 9, Iss. 1, (Jan/Feb 2003): 72-83.
7. MacPherson H, Thomas K., Walters S, et al. The York acupuncture safety study: prospective survey of 34,000 treatments by traditional acupuncturists. BMJ 2001; 323:486-87.
8. Witt CM, Pach D, Brinkhaus B, et al. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed 2009; 16:91-97.
9. Wu, J., Hu, Y., Zhu, Y., Yin, P., Litscher, G., & Xu, S., “Systematic Review of Adverse Effects: a Further Step Towards Modernization of Acupuncture in China.” Evidence-based Complementary and Alternative Medicine. July 2014.

Evidence demonstrating acupuncture’s effectiveness on chronic conditions such as low-back pain continue to grow and the NCCAOM appreciates CMS considering this treatment method as a viable service for Medicare beneficiaries. While the evidence base continues to grow, the NCCAOM recognizes that most of the cited studies do not specifically address individuals from the Medicare demographic.

The forthcoming AHRQ-sanctioned studies will help close this gap and CMS’ coverage will facilitate this research. Existing evidence that shows long-term benefits of an acupuncture treatment course suggests that such a treatment plan could provide steady relief to Medicare beneficiaries from a pain- and opioid-reliance standpoint—as well as long-term cost savings.

In seeking effective methods for treating cLBP, ensuring patient-safety is critical. As such, the NCCAOM commends CMS for requiring current NCCAOM-Board Certification for any individual providing acupuncture in sanctioned research. This criterion ensures that Medicare beneficiaries receive appropriate, safe, and effective care from individuals who have the proper training and experience in acupuncture.

Thank you again for this initiative and the public-comment opportunity. The NCCAOM stands by as resource in providing expertise, evidence, and quality standards to CMS-based acupuncture services.

Sincerely,

Afua Bromley, L.Ac., MSOM, Dipl.Ac.
Chair, NCCAOM Board of Commissioners

Mina M. Larson, M.S., MBA, CAE
Chief Executive Officer
NCCAOM

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This is an important study to potentially help millions of people with a non-pharmaceutical option for pain care. It is imperative that the proper persons, Licensed Acupuncturists perform the acupuncture. This kind of language would be ideal:

Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

As well, While I understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile.

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request is that the language of the proposed be updated:

• to include‘licensed acupuncturists’
• and remove physician assistants, nurse practitioners/clinical nurse specialists, and auxiliary personnel, since acupuncture/dry needling are not within their scopes of practice.

Furthermore, it is appropriate to remove requirements for physician supervision. Acupuncture is a licensed profession that is regulated by legislation in 48 states and the District of Columbia.

2,3 In order to apply for licensure, the majority of states require that acupuncturists: graduate from an accredited graduate school, pass national or state examinations, and are certified in clean needle technique.

3,4 While numerous states require practitioners pass National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) examinations before applying for licensure, the majority do not require continued certification with this organization.

2,3 The state of California has the largest number of licensed acupuncturists of all of the United States and provides its own examination that is separate from the NCCAOM.

5,6 The NCCAOM currently represents 18,105 acupuncturists, but it is estimated that there are approximately 30,000-35,000 licensed acupuncturists in the United States.

4,7 We request that the requirement for current NCCAOM certification be removed and replaced with ‘licensed acupuncturist’ so that all qualified practitioners can deliver treatment to Medicare recipients. As it stands, not only does this requirement obstruct nearly half of our profession from administering treatment to Medicare recip in California.

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August 14, 2019

Dear Dr. Miller and Mr. Dolan:

I commend the efforts by CMS to study the effects of acupuncture for chronic low back pain in populations covered by Medicare. I would like to thank the CMS for its consideration of this topic which represents an important step towards the incorporation of acupuncture into national health care.

California licensees represent nearly one-third of all licensed acupuncturists in the USA. Along with other relevant stakeholders who will be affected by the decisions made based on the outcomes of these planned studies, I am concerned about problems created by the language of the proposed decision memo and inconsistencies with existing law. I am seeking resolutions for these problems by the following suggestions:

1. Licensed acupuncturists are the main stream providers in California, they should be included in this study.
2. I want recognition of the California Acupuncture Licensing Exam to be equivalent to the NCCAOM exam fot the purposes of this study.
3. I want licensed acupuncturists to be recognized as independent practitioners, without the need for supervision by physician assistants, nurse practitioners and/or clinical nurse specialists.

Sincerely,

Yaohui Fang, L.AC

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I have worked with many cases of chronic low back pain at an acupuncture clinic and also at a massage spa. Acupuncture can help relieve the pain, as well as Tuina massage and decompression therapy. Many senior patients come for a combo treatment at our clinic for low back pain with acupuncture and Tuina. I also see many clients at the spa with low back pain and I treat them with massage and decompression therapy. My experience tells me that seniors prefer the touch aspect, so even though at the clinic we provide only 10-15 min Tuina Massage, that is complimentary with the acupuncture treatment, they look forward to the Tuina Massage always.

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

August 14, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)
Dear Dr. Miller and Mr. Dolan,

The Connecticut Society of Acupuncturists – (CTSA) is an organization representing 411 Connecticut licensed acupuncturists and is a member of the national organization, the American Society of Acupuncturists – (ASA). We want to express our support and great appreciation for your efforts to propose a nationwide study on the treatment of chronic low back pain with acupuncture for our population covered by Medicare. We also very much thank you for allowing us to provide some commentary on this important proposed decision memo (CAG-00452N).

As CTSA licensed acupuncturists, the treatment of low back pain constitutes a very large percentage of our patient population. Our extensive training, experience and ability to determine the various factors that play into each individual’s ‘pain’ enables a more highly likely effective treatment both in the short and long term for this patient population. Acupuncture is not ‘a one small set of needles placed in the same formation fixes all’. We have concerns that if it is done in this manner and done by those far less trained in all aspects of acupuncture, the study may prove to be disappointingly less effective than its full potential could be. Hence, we’d like to urge you to integrally utilize US licensed acupuncturist who are the most highly trained and experienced in the field of acupuncture in your study.

The following aspects of your proposed decision memo were addressed by the American Society of Acupuncture in a comment letter to you dated July 24, 2019. We fully support the concerns and the specific suggested revisions.

We would like to further emphasize and provide additional comments here as well.

Regarding your language about qualified providers of acupuncture for this study:

• It is important to note, regarding that most but not all states require the national certification by the NCCAOM – National Commission for Certification in Acupuncture and Oriental Medicine. Those particular states, California, for example, do require completion of a masters, first doctorate or doctorate program from an ACAOM accredited school and additionally those states do require an exam and certification that is either equal to or greater than the requirements of the NCCAOM.
• It is also important to note that there are no PA’s, NP’s or clinical nurse specialists who would meet these requirements unless they are holding dual licensure. This aspect of the proposal gives qualification for inclusion to providers that would otherwise not qualify unless they were licensed acupuncturists.
• Connecticut licensed acupuncturists, like licensed acupuncturists of other states are highly regulated. In Connecticut, we are licensed under our Dept of Health with a clear and detailed scope of practice and Practice standards equal to the other medical professions. We, like other independent medical providers are required to retain professional liability. Acupuncture is covered in and out of network by policies covering our state employees and retirees as well as by Connecticut worker’s compensation policies.
• Licensed Acupuncturists have played a vital leadership role and treatment provision in many evidence-based studies in this country and abroad. We reiterate the ASA’s comment that the term ‘licensed Acupuncturist’ be included, where appropriate, in all data collected and reported from these studies. We would like to see clear documentation of the types and training of practitioners who are making treatment decisions and providing acupuncture treatments as well as clear documentation on the techniques used and number of treatments provided.

Regarding your proposed language about needing supervision by a physician during trial purposes:

• In most of the states, licensed acupuncturists are independent providers who not only do not need physician referral in order for our services to be rendered, but also we are not required to retain supervision after graduation beyond our several years of supervised clinical training in our ACAOM accredited schools. There we were under supervision of Doctors of Acupuncture, never PA’s, Clinical Nurses, or MD’s. Our safety record as independent practitioners is outstanding, incidents are very limited in number. Although, we realize that a team, including a supervisor is necessary for trials such as this, it should not be considered the model by which acupuncture is provided for under Medicare in the future.

Essentially, this is a wonderful proposal and by utilizing highly trained and qualified licensed acupuncturists throughout the US to help create the treatment plans and supervise the actual acupuncture treatment aspect, your efforts will without doubt create a positive outcome for this population.

Again, thank you for this opportunity to provide comment and for your consideration of such.

Sincerely,
Margaret Barili RN, LAc, Dipl.Ac.
President and the board of the Connecticut Society of Acupuncturists.

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August 14, 2019

Ms. Seema Verma
Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
P.O. Box 8016
Baltimore, Maryland 21244-8016
RE: Proposed Decision Memorandum for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Administrator Verma:

The American Chiropractic Association (ACA) appreciates the opportunity to comment on the Proposed Decision Memorandum for Acupuncture for Chronic Low Back Pain (CAG-00452N) as announced by the Centers for Medicare & Medicaid Services (CMS) on July 15, 2019. ACA is the largest professional organization in the United States representing doctors of chiropractic (DC). ACA members lead the chiropractic profession by working together with other healthcare providers, supporting meaningful research, reporting functional outcome assessment measures and pledge adherence to the highest standards of ethics and patient care, contributing to the health and well-being of the estimated 35 million Americans who seek chiropractic care each year.

ACA applauds CMS for looking at alternatives to opioids and other pharmaceuticals in addressing low back pain. However, we are also concerned with the recent Memorandum, in that doctors of chiropractic who perform acupuncture services may be omitted as a provider group allowed to provide such services, or come under the heading of “auxiliary personnel,” which would need to be supervised by a physician or a physician assistant. With this concern in mind, ACA submits the following comments particularly in response to the Decision Summary, Subpoint B. Covered Indications for CMS approved studies.

Physician Status
Doctors of chiropractic, as well as medical doctors and doctors of osteopathy, are considered “physicians” under Section 1861(r) of the Social Security Act. In addition to their well-known preeminence in the field of spinal manipulation, many have extensive training and licensure in acupuncture. Additionally, many DCs hold special certification in acupuncture from the American Board of Chiropractic Acupuncture (ABCA), or from the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM).

Chiropractic Education and Training
All doctors of chiropractic give special attention to the physiological and biochemical aspects including structural, spinal, musculoskeletal, neurological, vascular, psychological, nutritional, visceral, emotional and environmental relationships. They are extensively trained in diagnosis, so they may treat patients effectively and make timely referral to appropriate health care providers.

The diagnostic and therapeutic practice and procedures which may be employed by doctors of chiropractic are based on the extensive and intense academic and clinical training received in and through chiropractic colleges accredited by the Council of Chiropractic Education (CCE) recognized by the U.S. Department of Education.

Acupuncture in Chiropractic
Chiropractic acupuncture is an approved specialty within the chiropractic profession and is the art, science and philosophy of treating disease and injury by stimulating specific energy modulating points on the skin. Methods of stimulation include, but are not limited to needle insertion, electrical stimulation, light, heat and pressure. Chiropractic acupuncture treats a wide variety of health conditions which includes all systems and tissues of the body and focuses special attention to the relationship between the spine, nervous system and the meridian system. Chiropractic acupuncture is inclusive of all diagnostic and therapeutic principles and procedures taught in acupuncture programs sponsored by CCE accredited colleges, chiropractic state associations and post-graduate certified instructors.

Doctors of chiropractic are licensed or certified in 34 states and the District of Columbia to treat patients using acupuncture procedures.¹ In addition, chiropractors employed by the U.S. Department of Veterans Affairs (VA) may also provide acupuncture or other therapies as non-pharmacological options for veteran care.² Also, the U.S. Navy, in their on-base hospitals and clinics, recognize chiropractors licensed in acupuncture to treat active-duty patients.³

Conclusion
ACA appreciates the opportunity to provide these comments for your consideration. We specifically request clarification regarding the provider types outlined in Decision Summary, Subpoint B. Covered Indications for CMS approved studies. ACA also submits that doctors of chiropractic should be included as eligible providers to both furnish acupuncture and to supervise the furnishing of acupuncture by auxiliary personnel. As stated above, ACA believes that the capabilities of doctors of chiropractic to provide acupuncture and to supervise auxiliary personnel furnishing acupuncture are well established through a DC’s education, training, state license and/or certification in acupuncture. If you have any questions regarding our comments or need more information, please contact John Falardeau at jfalardeau@acatoday.org or at (703) 812-0214.

Sincerely,

Robert C. Jones, DC
President

1 State Requirements for Chiropractic Acupuncture http://councilofchiropracticacupuncture.org/state-requirements.html
2 U.S. Department of Veterans Affairs, Rehabilitation and Prosthetic Services https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6425
3 Department of the Navy, Bureau of Medicine and Surgery, BUMED INSTRUCTION 6320.100 https://www.med.navy.mil/directives/ExternalDirectives/6320.100.pdf

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I support Medicare/Medicaid Coverage of acupuncture treatments for people who suffer from chronic low back pain.

I practice acupuncture in a low cost/high volume Community Acupuncture clinic and I have been licensed for 3 years. Low back pain is the most common reason why patients seek acupuncture. Acupuncture is better when used early on and not as a last resort. Acupuncture is safe, effective and completely drug-free.

Acupuncture can be used on its own or in conjunction with other kinds of pain treatments or medications. I have worked with many patients who have been able to reduce their medication when they have regular access to acupuncture. Some have gotten off of opioid medications entirely.

If Medicare/Medicaid should cover acupuncture for those with chronic low back pain, your agency should work with all licensed acupuncturists. If they have a valid state license, then they are qualified. Please do not limit this only to acupuncture practitioners who maintain national certification with the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). Every licensed practitioner takes the NCCAOM board exam or the very similar California exam. There is no difference in the quality of care that comes from acupuncturists who pay to keep their national certification and those who do not.

The Centers for Medicare and Medicaid Services should also consider creating billable codes to cover ear acupuncture for the treatment of Substance Use Disorder, Trauma, and all issues related to behavioral health. SAMSHA recognizes ear acupuncture as a treatment for SUD in TIP 45 and half of the states in the US allow for non-acupuncturist health providers and lay practitioners to practice ear acupuncture if they are certified by the National Acupuncture Detoxification Association or equivalent training.

Thank you for taking my input.

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Thank you so much for studying the effects of acupuncture on low back pain! As an acupuncturist, I clearly see the benefits of acupuncture for eldery individuals experiencing chronic pain, and it would help this population so much to have Medicare coverage.

I would like to request that Licensed Acupuncturists specifically be listed as approved providers, as we have the most extensive training in acupuncture itself (class hours and internship hours) as compared to PTs, Chiropractors, MD's, etc. This will ensure that should this get approved, the patients get the absolute best quality of care from licensed acupuncturists across the country.

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I am pleased to hear that CMS is considering covering acupuncture in the future, as I am sure many of my patients who are currently on Medicare and having to pay out of pocket for treatment will be. However, I am concerned about the wording in the proposal. I believe Licensed Acupuncturists and not PAs or NPs should be listed and agree with the wording proposed by the American Society of Acupuncturists, which states as follows.

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Please note that physicians assistants, nurses and nurse practitioners have no more hours of study for licensing than do acupuncturists. In California, acupuncturists complete current educational requirement of 3,000 hours of didactic and clinical training. Additionally, I strongly object to the term “auxiliary personnel” as the default term for licensed acupuncturists, who have obtained the unique Bureau of Labor Statistics (BLS) designation 29-1199.01 Acupuncturist, especially since we collectively have more training in this specialty than any other designation. I request that the term “licensed acupuncturists” be used and included everywhere appropriate to denote an acupuncturist, in all data collected and reported from these studies and in all documentation related to recruiting, study methods, and other coverage based on the outcomes of the studies requested by CMS, so that those decisions are based on the actual provision of care which would include not only the number of treatments and the techniques prescribed, but also the training, licensure and proper designation of the providers of this service.

While I understand the need for direct supervision by a physician during the official research study, it is inconsistent with California state law and with every other state law that licensed acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. As mentioned previously, certain aspects of California law prohibit supervision of acupuncturists by professionals who are not themselves licensed acupuncturists. There is no precedent for the inclusion of these professionals as supervisors of acupuncturists, nor does it improve patient safety, study design or provision, or any other aspect of the validation, assessment, or decision-making process of this effort. Licensed acupuncturists have an outstanding safety profile documented in all states regulating licensure. We ask that the terms “physician assistant” and “nurse practitioner/clinical nurse specialist” be removed in order to revise this portion for consistency with state laws.

As an acupuncturist I demand the respect I deserve as a qualified professional. I have studied and passed rigorous exams, and practice with the refinement created by detailed and careful training. Additionally, I believe the US Centers for Medical and Medicare should also evaluate through Meta-Analysis the thousands of studies made on the subject of acupuncture. There is enormous information already at the ready to utilize in the endeavor to further understand and qualify acupuncture, not only for low backs, but for pain all over the body, for neurological complaints, for anxiety, depression, hormonal imbalances, for certain aspects of endocrine regulation and for hypertension, to name a few. A Meta Analysis is far less costly and farther reaching, hence I urge the board to consider this as another step for due diligence in the pursuit of understanding and knowing how to improve healthcare in this great country. Thank you

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The Centers for Medicare and Medicaid Services (CMS) absolutely must do the proper due diligence regarding the pending federal study of acupuncture for chronic low back pain. This means including ALL licensed acupuncturists in the study and recognizing them as independent practitioners with no need of "supervision" by western medicine. It also means excluding other practitioners who are not licensed acupuncturists but who incorporate the (IMO) questionable and dangerous practice of "dry needling" into their "treatments".

Excluding acupuncturists who are licensed and have passed the California Licensing Exam but who are not NCCAOM certified would present a strongly skewed picture of the proliferation and success of acupuncture treatment for low back pain. A great majority of excellent practitioners don't bother with the NCCAOM exam if they don't plan to practice outside of California.

Additionally, licensed acupuncturists are not "auxiliary personnel" and should not be categorized as such. Acupuncturists are recognized as primary care physicians by Workers Comp providers and most insurance companies cover acupuncture treatment for low back pain. One of the most common ailments that causes patients to seek acupuncture treatment is low back pain, thus acupuncturists are especially skilled and experienced in treating this condition.

Lastly, licensed acupuncturists are medical professionals who earn Masters and Doctoral degrees in science and then pass an intensive five hour licensing exam. It is both insulting and grossly incorrect to suggest that licensed acupuncturists need "supervision by physician assistants, nurse practitioners and/or clinical nurse specialists" - especially since the above named western medicine practitioners generally possess zero training in acupuncture or Traditional Chinese Medicine.

In light of all of the above I strongly encourage the Centers for Medicare and Medicaid Services to include the following in the proposed study of chronic low back pain:

1. All licensed acupuncturists to be included in this study
2. Recognition of the California Acupuncture Licensing Exam to be equivalent to the NCCAOM exam for the purposes of this study.
3. Licensed acupuncturists to be recognized as independent practitioners, without the need for supervision by physician assistants, nurse practitioners, and/or clinical nurse specialists

Thank you for your time.

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

July 24, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

As a Member of the Acupuncture Society of New York (ASNY) and the American Society of Acupuncturists, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As my colleagues in the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile . In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

In the state of New York, this is the relationship required by statute between a Licensed Acupuncturist and Medical Doctors or Physicians: http://www.op.nysed.gov/prof/acu/acupunbroch.htm

“Acupuncturists are independent health care providers; you do not need a physician referral to receive treatment from an acupuncturist.
By law, your acupuncturist must advise you of the importance of your seeing a physician. When this is done, you will be asked to sign a form saying that you were advised of this. You will get one copy of this form, and a second copy will become part of your record.”

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely.
Gerard Maggio LAc

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To Whom It May Concern,

Thank you for considering this study to assess acupuncture as an option for our medicare members suffering from chronic lower back pain.

I would like to express my concern over some of the proposals mentioned in the decision memo. I am a California State Licensed Acupuncturist with over 3000 hours of clinical training and am confused as to why acupuncturists with my extensive training are not mentioned as being able to participate in this study without an additional NCCAOM certification (which has been independently authenticated to be an equivalent training) or why acupuncturists have been labeled "auxillary personnel" where we are trained and certified to diagnose, treat and manage the care of patients with diseases and injuries such as "chronic low back pain" specifically.

Licensed Acupuncturists have more training in the safe and effective administration of acupuncture than any other medical profession and should be referenced as the primary administrators of care on this issue, without the need of supervision.

Thank you for taking the time to consider the contents of this comment. Please do not hesitate to reach out should you require any further information.

Kind regards,

Tamryn Hawker LAc
CALATMA Member

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First of all I would like to thank CMS for consideration of this topic. Acupuncture and Chinese medicine, when performed properly, will revolutionize the practice of medicine in the United States. I must emphasize the proper performance of acupuncture and Chinese medicine because this is a significant factor in determining the efficacy of a therapeutic modality. For example, while acupuncture and dry needling are essentially identical modalities, acupuncturists have the proper theoretical framework from which to perform acupuncture in a much more effective way than a chiropractor or physical therapist who simply learned the modality but without it's proper theoretical framework. To clarify this, I would ask that the section that includes "auxiliary providers" be changed to more clearly name "Licensed Acupuncturists or state equivalent". Along similar lines I would also recommend that the supervision required during the study portion be only done by a Medical Doctor. Supervision by any other licensure type does not have a precedent, nor does it add in any way to the safety or quality of the trials. This is only for the trial phase of course, general practice need not be supervised by an MD, and this is the current case in the state of Maryland where I practice.

I am very excited at the potential for acupuncture to be accessible to the greater public, even if at first only for chronic lower back pain. Not only does acupuncture help manage the pain without deadly opioids, but Chinese medicine perspective also allows for the identification and treatment of root causes that will improve general health and pain outcomes.

Thank you for your time,
Yaron Cohen, L.Ac., Dipl.OM.

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

To Everyone Working Very Hard to Provide Acupuncture :

Acupuncturists and recipients of Medicare applaud efforts by CMS to study the effects of acupuncture for chronic low back pain in populations covered by Medicare. I have been licensed to practice Chinese medicine and acupuncture since September of 2001. Over the years, many people with Medicare coverage have called to ask if acupuncture is covered. It would be outstanding to answer, yes Medicare covers acupuncture. Most consistently, people call to inquire about Chinese medicine and acupuncture to help reduce, or when possible, eliminate the use of medication. Medicare coverage would not only offer treatment for the root of a problem and guide people through the possibilities of reducing the use of pain medication, but also help ease financial burdens. Additionally, state licensed acupuncture providers with a Master or Doctorate in Chinese medicine are also knowledgable in identifying conditions that require referrals to other health care providers. In other words, we know when acupuncture is not the entire answer.

It is worth mentioning the Veterans Administration and the Federal Government Workman’s Compensation programs. These two government agencies have been providing acupuncture for many years. The VA and FGWC have worked through the bumps along the way and leave a clear idea of a system that works to provide federally funded acupuncture care for the veteran population.

I have been advocating for veteran health care for fourteen years, started a non-profit for veterans and their immediate family members, and now serve as a health care provider for Care in the Community (VAPC3) through the Cheyenne and Denver Veterans Administration. The VA has streamlined the process of using community care providers; combining the Choice Program and NonVACare into VAPC3. Currently, acupuncture codes use a Medicare Fee Schedule. Prior to this fairly new program that has successfully provided care for veterans closer to their home despite many necessary updates and changes, I have seen veterans through the Federal Government Workman’s Compensation program. Through FGWC, Acupuncture visits were authorized appropriately, whether for short term, post-surgery, or maintenance. The fee schedule was set by the FGWC, the process was fairly simple, calling to ask questions regarding billing was very helpful, and payments for clean claims were received exactly two weeks after post-mark date. This was at a time when hand written referrals came from the Primary Care Provider at the VA, forms were filled out by hand, and a carbon copy was retained by the health care provider. The first year I obtained authorization to see a veteran through FGWC was in 2005. I continue to be actively involved with veteran health care.

Again, thank you for considering acupuncture coverage by state licensed acupuncturists.

Daisy Lear

Also, I agree with statements in this letter from the Board of the American Society of Acupuncturists:

July 24, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

On behalf of the American Society of Acupuncturists and our 4500 members nationwide, we applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As representatives of the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, we seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹ The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE).³ We propose alternate language for this section in toto that simply reads:

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile⁴. In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely,
The Board of the American Society of Acupuncturists

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I'm an acupuncturist at Wasatch Community Acupuncture, a large non-profit clinic that offers acupuncture on a $15-$40 sliding scale. We are members of the national cooperative called the People's Organization of Community Acupuncture (POCA), that is committed to making acupuncture as accessible and affordable as possible. I've had nine years experience treating people with chronic low back pain. As with any medicine acupuncture doesn't work 100% of the time but it works much of the time and has the potential to change peoples quality of life. If access is increased and more people receive acupuncture for things like chronic low-back pain the need for and use of pain medicationgs will dramatically decrease. Acupuncture is minimally invasive and inexpensive, making it ideal for chronic issues. Acupuncture also has a relaxing effect on the nervous system so many patients also report a reduction in there stress and anxiety levels, an added bonus. Please, if possible make acupuncture a part of Medicare services.

Also, if Medicare/Medicaid should cover acupuncture for those with chronic low back pain, your agency should work with all licensed acupuncturists. If they have a valid state license, then they are qualified. Please do not limit this only to acupuncture practitioners who maintain national certification with the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). Every licensed practitioner takes the NCCAOM board exam or the very similar California exam. There is no difference in the quality of care that comes from acupuncturists who pay to keep their national certification and those who do not.

Thank you.

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[PHI Redacted] I want to thank the CMS for your consideration of this important topic if adding acupuncture to Medicare so more Americans can receive it's benefits.

However, in reading how the CMS proposes to investigate acupuncture here are a few recommendations:

1. The section that includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describe this licensure group.
2. I also ask that the supervision required during the study portion be done only by an MD as others do not have the proper training and it is unnecessary.

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To CMS:
1) Thank you for your consideration of this important and necessary topic for our national health care.
2) Please change the section indicating the inclusion of "auxiliary providers" to "Licensed Acupuncturists or state equivalent." It is extremely important for the treatments to be administered by trained and licensed acupuncturists, for the safety of patients (for example: SCUHS (Southern California University of Health Sciences) is a non-profit and regionally, state, and professionally accredited institution in CA. Graduates from the doctorate of acupuncture & Chinese medicine program must complete the training program with a minimum of 3945 hours.)
3) The supervision required during the study portion to be done only by a physician. Please remove other professionals such as physician assistants, nurse practitioners or clinical nurse specialists for supervising licensed acupuncturists, as this is inconsistent with state regulations not does it provide safety to patients.

Thank you.

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The CA board of acupuncture is parallel if not more rigorous than the NCCAOM and California licensee acupuncturists (L.Ac.) have reciprocity with NCCAOM that it does not make sense to exclude L.Ac’s.

U.S acupuncture programs range from masters to doctorate programs that include fundamental basics of anatomy, physiology, biology and chemistry like any other health profession such as physicians assistant or nursing. Acupuncturists are licensed to have the clinical autonomy of treating our own patients and it does not make sense to have a PA or NP supervise us when what we do is different from their scope of practice for chronic low back pain management. Acupuncturists are trained to exam and screen patients and know to refer patients to doctors and other specialists for concerns outside our scope of practice. Open line of communication integrating therapies is essential but direct management would be hindering, inefficient and does not benefit the patient.

Non-acupuncturists such as PT, DC etc performing acupuncture would be less effective and pose safety risks to patients since they do not have the same extensive training. PT, chiro, and other health care professionals would provide more effective care to their patients by focusing treatment protocols within their scope of practice and referring to an acupuncturist if need for additional benefits managing chronic low back.

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The Center for Inquiry (CFI) appreciates this opportunity to comment on the proposed decision memo, Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N).

CFI Is a Charitable Nonprofit Organization Dedicated to Advancing Evidence-Based Policy.
CFI is an educational and advocacy organization that promotes reason and scientific integrity in public affairs. CFI’s vision is a world where people value evidence and critical thinking, where superstition and prejudice subside, and where science and compassion guide public policy. Our comments are submitted not only on behalf of our organization, its employees, and its members but also on behalf of dozens of doctors and scientists associated with CFI and its affiliate program the Committee for Skeptical Inquiry (CSI) and CFI’s division, the Richard Dawkins Foundation for Reason & Science, with whom we work on these matters.

Since its inception, CFI has been a prominent advocate of evidence- and science-based policy in all branches of government. In 2016, CFI submitted an amicus brief on behalf of many scientists, science educators, and skeptics to the U.S. Supreme Court arguing that a Texas law that restricted access to women’s reproductive health care was based on unscientific information gathered by an individual with no medical qualifications. The Court ruled in favor of CFI’s position.

In addition, CFI engages in civic education to improve scientific literacy in the United States. In 2015, as a result of CFI’s and CSI’s efforts, the Associated Press announced that it would no longer use the term skeptic to describe individuals who reject the mainstream science of climate change.

A primary focus of CFI’s work is preventing public harm from policies, initiatives, or institutions that fail to adhere to known scientific facts or principles. The “alternative medicine” industry, described in detail below, is such an institution.

One of the most egregious examples of harmful “alternative medicine” is homeopathy, a category of products based on the disproven eighteenth-century theory that when diluted to virtually nonexistent concentrations, toxic substances transfer invisible healing properties to ordinary water molecules. Not only is this theory unsupported by evidence, it violates known properties of chemistry and physics.

In April 2015, CFI testified to the Food and Drug Administration (FDA) about homeopathy’s potential harm and the need to hold homeopathic drugs to the same standards of safety and efficacy as conventional medicine.

In November 2015, following the Federal Trade Commission’s Homeopathic Medicine & Advertising Workshop, CFI filed comments urging them to stop manufacturers from falsely advertising homeopathy’s safety or efficacy until such claims can be scientifically proven.

In November 2016, the Federal Trade Commission (FTC) issued a staff report on the Homeopathic Medicine & Advertising Workshop, which cited CFI’s comments. Concurrent with the report, the FTC issued new enforcement guidance for homeopathic products, which declared that homeopathic products cannot include claims of effectiveness without “competent and reliable scientific evidence.” If no such evidence exists, homeopathic products must state this fact clearly on their labeling and state that the product’s claims are based only on eighteenth-century theories that have been discarded by modern science.

In July 2018, CFI filed suit against CVS Health, the largest retail pharmacy chain in the United States, for fraudulently marketing homeopathic products in the District of Columbia. That case is currently progressing.

The Evidence Does Not Support Acupuncture as a Safe, Effective Treatment for Chronic Low Back Pain.
The preponderance of evidence does not support the efficacy of acupuncture as a treatment for low back pain. Contrary to the claims of practitioners and proponents, acupuncture is a medically ineffective practice with no grounding in modern medical theory. Furthermore, acupuncture causes substantial harm to patients, both in its attendant risks and in the temptation to substitute it for scientifically proven treatments. First, it wastes valuable patient time and money that could be devoted to effective treatments. Even worse, the unnecessary insertion of needles into the skin can cause health complications including infection and, in at least two known cases, lung puncture. Although every medical intervention carries some risk, the adverse effects caused by acupuncture, while rare, outweigh any medical benefit because there is no benefit. For these reasons, acupuncture should not be covered under Medicare.

Multiple meta-analyses have shown that acupuncture does not outperform a placebo in relieving back pain. In properly designed double-blind controlled trials, acupuncture does not outperform “sham” acupuncture, in which needles are placed in locations not indicated by the theory of acupuncture. Nor does it outperform a placebo in which no needles are inserted into the body at all. In other words, it doesn’t matter where you stick the needles, and it doesn’t matter if you stick the needles in at all. Whatever effect is observed due to acupuncture is entirely nonspecific.

Studies purporting to show that acupuncture outperforms placebo suffer from serious design flaws that obviate their credibility. The majority of these studies do not control for the placebo effect by comparing the efficacy of acupuncture to that of a placebo. Instead, they compare the effect of other medical interventions to the effect of those interventions plus acupuncture. This design contains the serious flaw that additional interventions will nearly always appear to have greater effect than an original intervention alone, regardless of their efficacy or lack thereof.

Studies that appear to demonstrate a significant therapeutic effect of acupuncture generally fail to isolate acupuncture as an independent variable to which the hypothesized effect can be clearly attributed. For instance, a 2009 article published in Archives of Internal Medicine found no difference in outcome between individualized acupuncture, standardized acupuncture, and sham acupuncture. It did not matter whether needles were inserted in the proper locations according to the theory of acupuncture; patient results were the same. A 2013 meta-analysis published in the American Journal of Chinese Medicine found that acupuncture did not outperform sham acupuncture, leading the researchers to conclude that any temporary pain relief associated with acupuncture is not due to the needling but “is likely to be produced by the nonspecific effects of manipulation.” A 2017 study in Australia compared the analgesic effects of acupuncture alone, acupuncture plus pharmacology, and pharmacology alone. The study found no statistically significant difference between any of the three groups in pain relief in the first hour following treatment. However, after this first hour concluded, patients in the acupuncture-only group were almost twice as likely as patients in the other two groups to request “rescue medication” to treat unalleviated symptoms (at T1: P=0.016; after T1: P=0.008).

Other studies have found mixed effects suggesting a placebo effect that is not clinically relevant. The pain-relieving effect associated with acupuncture is short-lived, generally only providing relief in the moments immediately following application of the treatment.

In light of the preponderance of evidence that acupuncture is not effective for treating low back pain, further research would be a misallocation of CMS’s effort and resources. Even reimbursement for acupuncture in clinical trials testing it for low back pain would not be scientifically or medically justified. There are other funding sources for such trials, and those who believe acupuncture to be efficacious for the relief of low back pain should be the ones funding such trials, not Medicare, where funding such trials increases expenses and potentially shifts funding away from science-based medical care to study pseudoscience.

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On behalf of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons, we appreciate the opportunity to submit our comments regarding proposed coverage for acupuncture for chronic low back pain (CAG-00452N)

August 14, 2019

Tamara Syrek Jensen, Esq.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Ms. Jensen:

On behalf of the American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves (DSPN) and the AANS/CNS Section on Pain, we appreciate the opportunity to provide our comments on the Centers for Medicare & Medicaid Services’ (CMS) National Coverage Determination (NCD) for Acupuncture for Chronic Low Back Pain (CAG-00452N).

We believe that in many cases, conservative management is appropriate for patients with chronic pain before considering surgical intervention, and there may be a role for acupuncture for patients with chronic low back pain. Therefore, we are not opposed to coverage for acupuncture treatment for Medicare patients enrolled in clinical trials supported by the National Institutes of Health or in CMS-approved studies meeting Agency for Healthcare Research and Quality (AHRQ) criteria. The data appear to be conflicting regarding the benefit of acupuncture for chronic low back pain, but it may play more of a role for acute low back pain. As such, we believe that it is reasonable to support the NCD for coverage of acupuncture for acute, and possibly chronic, low back pain patients enrolled in clinical trials Although CMS has received numerous comments from providers stating that acupuncture has been in existence for thousands of years, anecdotal claims are not equal to scientific evidence.

We would also like to emphasize the importance of exhaustive diagnostic imaging and comprehensive neurological assessment to identify those individuals who would benefit most from timely surgical intervention, as opposed to non-operative measures. For some patients with a structural element to their pain, such as scoliosis, spondylolisthesis, metastatic or primary neoplastic disease, the literature demonstrates the cost-benefit of timely intervention. Delaying surgery could potentially cause harm to these patients, and no amount of acupuncture will address the underlying structural cause of the pain.

We would also like to highlight studies that demonstrate patient and cost-benefit to timely access to neuromodulation for chronic pain patients. We appreciate the recognition in the recently released HHS Pain Management Best Practices Inter-Agency Task Force Report of high-quality evidence for neuromodulation, including spinal stimulation, new waveforms, and spinal infusion pumps and the recognition regarding difficulty with insurance coverage for these procedures. This is an area of growth and innovation for chronic pain treatment. Spinal cord stimulation and dorsal root ganglion stimulation, collectively, have five level-1 studies demonstrating their efficacy in low-back and lower extremity pain. Peripheral nerve stimulation has gained popularity and effectiveness with the recognition of peripheral nerve entrapments, increased use of ultrasound and improvement in technology.

Thank you for considering our recommendations on the proposed NCD for Acupuncture. If you have any questions or need additional information, please contact us.

Sincerely,

Christopher I. Shaffrey, MD, FAANS, President
American Association of Neurological Surgeons

Ganesh Rao, MD, FAANS, President
Congress of Neurological Surgeons

Zoher Ghogawala, MD, FAANS, Chair
AANS/CNS Section on Disorders of the Spine and Peripheral Nerves

Jason M. Schwalb, MD, FAANS, Chair
AANS/CNS Section on Pain

CC: Susan Miller, MD, CMS Lead Medical Officer
David Dolan, MBA, CMS Lead Analyst

Staff Contact:
Catherine Jeakle Hill
Senior Manager, Regulatory Affairs
AANS/CNS Washington Office
25 Massachusetts Avenue, NW, Suite 610
Washington, DC 20001
Phone: 202-446-2026
E-mail: chill@neurosurgery.org

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As a licensed acupuncturist for nealrly 20 years, I know how useful acupuncture is in cases of CLBP among other complaints. While I am excited about the move towards the expansion of acupuncture into the Medicare/Medicaid systems, I am concerned with the language of the Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N). As it is currently written, it threatens to obstruct significant numbers of licensed acupuncturists from participating in current and future trials.

My request is that the language of the proposed memo be updated:

• to include ‘licensed acupuncturists’
• and remove physician assistants, nurse practitioners/clinical nurse specialists, and

It is important to note that acupuncture is a licensed profession that is regulated by legislation in 48 states and the District of Columbia. Therefore, it is appropriate to remove requirements for physician supervision.

Additionally, while numerous states require practitioners pass National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) examinations before applying for licensure, the majority do not require continued certification with this organization. Our state of Colorado does not require continued certification to maintain licensure. I would request that the requirement for current NCCAOM certification be removed and replaced with ‘licensed acupuncturist’ so that all qualified practitioners can participate.

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RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

I am so grateful for the efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a Licensed Acupuncturist (L.Ac.) I want to seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below: Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

While I understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. I ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. I am delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment. Chronic low back pain is one of the most common things I personally treat in my clinic and the reduction of pain and quality of life improvement as a result of acupuncture are impressive in my experience.

Wishing you all the best,
Jennifer Brittenham, MS, LAc

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

August 14, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

As a Member of the Acupuncture Society of New York (ASNY) and the American Society of Acupuncturists, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As my colleagues in the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

Thank you for at last beginning a process of at least studying the incorporation of acupuncture within Medicare coverage. I have been in practice for 23 years, and have been advocating and hoping for this the entire time. My patient base is largely over 60, with some in their 80s and 90s. Their income tends to be limited, and insurance coverage is crucial.

No matter how you go about this process, the thing to keep in mind is that acupuncture is a huge help to the health and quality of life of Americans over 65 (just as it is for those who are younger). Licensed acupuncturists commonly treat conditions that affect seniors disproportionately, such as arthritis, with low back pain being one of the conditions we see most often in our clinics.

Since my colleagues at the American Society of Acupuncturists have made extensive comments on this matter, I will not waste your reading time repeating everything they have written. However, I would like to emphasize a few of their points.?

“Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.”

As my colleagues explained, there are a number of problems with this description, including the relationship of California LAcs to NCCAOM certification, and it should be replaced with this simple statement or something close to it:?“Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.”

The ASA letter to Dr. Miller and Mr. Dolan adds:
‘While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile…. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist.”’

Here in New Mexico, licensed acupuncturists are designated Doctors of Oriental Medicine, and are considered physicians according to the language in our state practice act. This term reflects what we really do as first-line health care providers. It is not necessary to have a referral to see us, and we are not under supervision by medical doctors or anyone else. The state recognizes that we are thoroughly trained and that we go through testing not only at the national level but by a state exam that ensures we are qualified to practice safely and effectively. We have been licensed and regulated in our state since the 1980s.

When I was in school in the early 1990s, our program consisted of 4 academic years, on top of at least two years of other college work; it has gotten a good deal longer since. Before that, I had another degree plus most of a premed-type program of university study under my belt; this is not unusual. Many of my colleagues are also RNs or PTs in addition to their acupuncture licensure.? In other words, it would really not make a lot of sense to have practitioners other than MDs supervising licensed acupuncturists in studies. Of course it is to be hoped that anyone who supervises these studies should be well-versed in research design, no matter what their licensure category is.

I am writing these comments as an individual practitioner, but I am also the secretary of the New Mexico Society for Acupuncture and Asian Medicine.

Thank you again, and best wishes for this endeavor.

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The proposed document would allow certain non-acupuncturists to provide acupuncture services. I believe this this should define their credentials beyond NCCAOM and should be within their scope in the state they are practicing, and in the case of California, have the equivalent of NCCAOM certification according to state regulations. In Caifornia's instance, their examination is called the CALE and is equivalent, if not more strenuous and comprehensive, than the NCCAOM. This proposal excludes California licensed acupuncturists most of which have not also been certified by the NCCAOM. Until the NCCAOM is used in all states, there should be provisions that recognize this. This proposal also labels licensed acupuncturists as "auxiliary personnel". Acupuncturists should be named in this proposal, especially since they are primary care in some states like California. In California acupuncturists do not need to be supervised by physician assistants, nurse practitioners and/or clinical nurse specialists or MDs. I understand that this proposal is nationwide, but it should also align with state regulations and recognize the value that the acupuncture profession has added and the education they have.

I appreciate your consideration of the recommendations cited above.

Thank you,

Scott Phelps

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While it is strongly commendable that this study is trying to prove the efficacy of Acupuncture for chronic low back pain, the exclusion of Licensed and Board Certified Acupuncturists from the primary investigator positions and allowing non-licensed persons to perform Acupuncture instead is not only insulting to the Acupuncture profession at large, it will also undermine the efficacy of your study.

Only licensed Acupuncturists have the full knowledge and experience to impart as primary investigators to a study of this scale and importance. I strongly urge the CMS to reconsider your position in regards to this study.

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Dear CMS,
Thank you for considering including acupuncture in Medicare.

I am asking that you change the section that includes “auxiliary providers” to be changed to more clearly name “Licensed Acupuncturists or the state equivalent”. The qualifications for auxiliary providers exactly describes this licensure group.

As a certified acupuncturist in Wisconsin, I hold a Masters of Science in Traditional Chinese Medicine. I needed over 1,000 hours of training and supervised practice to obtain this degree and also passed the 4 National Acupuncture Board exams. Allowing practitioners of other fields to use acupuncture without sufficient training would be detrimental to the outcomes of the study and the overall success of using acupuncture to treat back pain in the general population.

Also, please only allow M.D.s to supervise the trials to ensure the safety and quality of the trial.

I hope that acupuncture will be covered by Medicare for back pain and other pains in the near future. I see so many patients over 65 who benefit greatly from acupuncture which allows them to decrease medications and prevent surgery. It is a very cost effective, safe and powerful form of medicine. It is unfortunate that most of my elderly patients have to pay out of pocket and therefore cannot always get all of the treatments needed to resolve their problems.

Thank you for taking all of this information into consideration.

Kind regards,
Alison Werner

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RE: Policy coverage of acupuncture for Chronic Low Back pain

Thank you for the opportunity to reply with comments on acupuncture for chronic low back pain. I really wanted to comment before you created your draft proposal. I will just put my comments in sections that you can use to discuss the policy decision on the coverage of acupuncture for chronic low back pain.

Acupuncturists in Minnesota
Acupuncturists are a new profession. Minnesota requires those that practice acupuncture to become licensed in Minnesota and those exempt from Minnesota statute are Medical Doctors and eligible chiropractors are required to be registered and certified by the Minnesota Board of Chiropractic to provide acupuncture. In Minnesota we are independent providers and work with and refer to all kinds of provider types when we provide health care services. There are some limitations to our scope to protect patient safety. https://mn.gov/elicense/a-z/?id=1083-231337#/list/appId//filterType//filterValue//page/1/sort//order/

As acupuncturists we not only provide acupuncture services but we provide skilled therapy services that may be necessary to improve a patient’s current medical condition, to maintain the patient’s current condition or to prevent or slow further deterioration of the patient’s condition. Acupuncturists are mid-level practitioners and most are considered non physician providers and I believe we should be a covered provider in Medicare Benefit Policy Chapter 15-Covered Medical and Other Health Services under the 220.2 Reasonable and Necessary Outpatient Rehabilitation Therapy and I would encourage Local Coverage Determinations to include Acupuncturists as a qualified provider. I would also like to see acupuncturists be included in Inpatient Rehabilitation Therapy as well as in emergency room care.

The following information is regarding the nature of the profession in the state on provider types. I have also included information concerning Minnesota Medicaid coverage of acupuncture and provider type that can provide acupuncture. Acupuncturists when providing acupuncture for Medicaid in Minnesota patients are no longer required to be a physician extender and the requirement to be supervised. I would request that the language regarding the provider type eligible in the studies would allow Acupuncturists to lead the studies and if the study needs the administration of a physician or similarly situated profession who is acting within his license to conduct human research studies. The language should be changed to allow flexibility to study design when states such as Minnesota have specific laws on how acupuncture is practiced without the supervision of physicians. I would like to see a Minnesota organization conduct some of the studies on acupuncture and chronic low back pain.

History: Acupuncturist’s have been licensed in the state of Minnesota since 1995. Minnesota Statute 147B establishes the practice of acupuncture when provided by Acupuncturists. The scope of acupuncture practice is as follows:

"Acupuncture practice" means a comprehensive system of health care using Oriental medical theory and its unique methods of diagnosis and treatment. Its treatment techniques include the insertion of acupuncture needles through the skin and the use of other biophysical methods of acupuncture point stimulation, including the use of heat, Oriental massage techniques, electrical stimulation, herbal supplemental therapies, dietary guidelines, breathing techniques, and exercise based on Oriental medical principles.
Acupuncturists Licensed by the Board of Medical Practice Effective September 6, 2018
Female: 459
Male: 136
Total: 595

Recent recognition by the Bureau of Labor Statistics establishes the new job title of Acupuncturists.

Information currently available through O*Net describing the scope of work of Acupuncturists shows that not only do we provide services of acupuncture but create a wellness care. https://www.onetonline.org/link/summary/29-1199.01

Provide treatment of symptoms and disorders using needles and small electrical currents. May provide massage treatment. May also provide preventive treatments.

Tasks

• Insert needles to provide acupuncture treatment.
• Maintain and follow standard quality, safety, environmental and infection control policies and procedures.
• Adhere to local, state and federal laws, regulations and statutes.
• Identify correct anatomical and proportional point locations based on patients' anatomy and positions, contraindications, and precautions related to treatments such as intradermal needles, moxibustion, electricity, guasha, or bleeding.
• Maintain detailed and complete records of health care plans and prognoses.
• Analyze physical findings and medical histories to make diagnoses according to Oriental medicine traditions.
• Treat patients using tools such as needles, cups, ear balls, seeds, pellets, or nutritional supplements.
• Develop individual treatment plans and strategies.
• Evaluate treatment outcomes and recommend new or altered treatments as necessary to further promote, restore, or maintain health.
• Collect medical histories and general health and life style information from patients.
• Dispense herbal formulas and inform patients of dosages and frequencies, treatment duration, possible side effects and drug interactions.
• Assess patients' general physical appearance to make diagnoses.
• Educate patients on topics such as meditation, ergonomics, stretching, exercise, nutrition, the healing process, breathing, or relaxation techniques.
• Formulate herbal preparations to treat conditions considering herbal properties such as taste, toxicity, effects of preparation, contraindications, and incompatibilities.
• Consider Western medical procedures in health assessment, health care team communication, and care referrals.
• Apply heat or cold therapy to patients using materials such as heat pads, hydrocollator packs, warm compresses, cold compresses, heat lamps, or vapor coolants.
• Apply moxibustion directly or indirectly to patients using Chinese, non-scarring, stick, or pole moxa.
• Treat medical conditions using techniques such as acupressure, shiatsu, or tuina.

Technology Skills

• Medical software — AcuBase Pro; Electronic health record EHR software; Qpalm Acupuncture; QPuncture II (see all 7 examples)
• Spreadsheet software — Microsoft Excel

Tools Used

• Acupuncture magnet pellet or seed — Therapeutic acupuncture magnets
• Acupuncture needle — Ear tacks
• Balance beams or boards or bolsters or rockers for rehabilitation or therapy — Positioning bolsters
• Bandage scissors or its supplies — Bandage scissors; Scissor pincettes
• Commercial use food grinders — Herb grinders
• Electric vibrators for rehabilitation or therapy — Ultrasound massagers; Vibration massagers
• Electronic blood pressure units — Blood pressure monitors
• Floor grade forceps or hemostats — Angle tip forceps; Hemostat clamps; Lockable forceps; Splinter forceps
• Foot care products — Foot rollers
• Handheld thermometer — Handheld digital thermometers
• Hypodermic needle — Filiform acupuncture needles; Intradermal acupuncture needles; Press needles; Seven-star needles; ear seeds
• Ion analyzers — Air ion testers
• Ion exchange apparatus — Ionizers
• Lancets — Lancet needles; Three-edged bloodletting needles
• Lasers — Crystal probes; Laser pens
• Mats or platforms for rehabilitation or therapy — Massage chairs; Massage tables
• Medical acoustic stethoscope or accessory — Dual head stethoscopes
• Medical diagnostic pinwheels — Wartenberg pinwheels
• Medical heat lamps or accessories — Digital heat lamps; Infrared heat lamps; Mineral wave lamps; Portable heat lamps
• Medical hydrocollators or accessories — Hydrocollator units
• Medical tuning forks — Acutonics tuning forks
• Mercury blood pressure units — Adenoid sphygmomanometers
• Needle guides — Acupuncture needle guide tubes; Needle inserters; Needle plungers
• Needle or blade or sharps disposal container or cart — Biohazard containers
• Neurological diagnostic sets — Acupuncture ear probes
• Neuromuscular stimulators or kits — Digital electronic acupunctoscopes; Electroacupuncture stimulation units; Electrical muscle stimulators, four sensor probes; Microcurrent systems; Pulsed magnetic field generators; Pen probes
• Ophthalmoscopes or otoscopes or scope sets — Otoscopes
• Reflex hammers or mallets — Babinski hammers; Buck neurological hammers; Taylor-type percussion hammers
• Steam autoclaves or sterilizers — Autoclave sterilizers
• Surgical clamps or clips or forceps or accessories — Adson forceps; Dressing forceps
• Surgical scissors — Operating scissors
• Therapeutic balls or accessories — Gua sha tools; Manaka hammers; Rolling drums
• Therapeutic heating or cooling pads or compresses or packs — Glass cupping sets; Magnetic cupping sets; Moxa extinguishers; Moxa spoons; plastic cupping sets;Therapeutic cooling packs; Therapeutic heating packs
• Therapeutic heating or cooling units or systems — Moxa boxes; Moxa burners; Moxa cans; Tiger warmers; Moxa burning bowls
• Tongue depressors or blades or sticks — Tongue depressors
• Transcutaneous electric nerve stimulation units — Trancutaneous electrical nerve stimulation TENS units
• Tweezers — Tack tweezers; Wide grip tweezers
• Vacuum pumps — Ion pumps
• Wrist exercisers for rehabilitation or therapy — Hand exercise balls; Hand rollers; Magnetic finger rings

Knowledge

• Medicine and Dentistry — Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
• Customer and Personal Service — Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
• Psychology — Knowledge of human behavior and performance; individual differences in ability, personality, and interests; learning and motivation; psychological research methods; and the assessment and treatment of behavioral and affective disorders.
• Therapy and Counseling — Knowledge of principles, methods, and procedures for diagnosis, treatment, and rehabilitation of physical and mental dysfunctions, and for career counseling and guidance.
• English Language — Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
• Biology — Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
• Sales and Marketing — Knowledge of principles and methods for showing, promoting, and selling products or services. This includes marketing strategy and tactics, product demonstration, sales techniques, and sales control systems.

Skills

• Active Listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
• Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Service Orientation — Actively looking for ways to help people.
• Social Perceptiveness — Being aware of others' reactions and understanding why they react as they do.
• Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.
• Speaking — Talking to others to convey information effectively.
• Monitoring — Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
• Reading Comprehension — Understanding written sentences and paragraphs in work related documents.
• Writing — Communicating effectively in writing as appropriate for the needs of the audience.
• Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making.
• Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
• Coordination — Adjusting actions in relation to others' actions.

Abilities

• Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
• Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
• Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
• Near Vision — The ability to see details at close range (within a few feet of the observer).
• Oral Expression — The ability to communicate information and ideas in speaking so others will understand.
• Speech Clarity — The ability to speak clearly so others can understand you.
• Speech Recognition — The ability to identify and understand the speech of another person.
• Written Comprehension — The ability to read and understand information and ideas presented in writing.
• Finger Dexterity — The ability to make precisely coordinated movements of the fingers of one or both hands to grasp, manipulate, or assemble very small objects.
• Flexibility of Closure — The ability to identify or detect a known pattern (a figure, object, word, or sound) that is hidden in other distracting material.
• Written Expression — The ability to communicate information and ideas in writing so others will understand.
• Arm-Hand Steadiness — The ability to keep your hand and arm steady while moving your arm or while holding your arm and hand in one position.
• Category Flexibility — The ability to generate or use different sets of rules for combining or grouping things in different ways.
• Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
• Visualization — The ability to imagine how something will look after it is moved around or when its parts are moved or rearranged.

Work Activities

• Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
• Assisting and Caring for Others — Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.
• Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.
• Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
• Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.
• Performing for or Working Directly with the Public — Performing for people or dealing directly with the public. This includes serving customers in restaurants and stores, and receiving clients or guests.
• Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
• Monitor Processes, Materials, or Surroundings — Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
• Thinking Creatively — Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
• Communicating with Persons Outside Organization — Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
• Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them.
• Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.
• Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used.
• Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
• Judging the Qualities of Things, Services, or People — Assessing the value, importance, or quality of things or people.
• Performing General Physical Activities — Performing physical activities that require considerable use of your arms and legs and moving your whole body, such as climbing, lifting, balancing, walking, stooping, and handling of materials.
• Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
• Provide Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
• Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.

Detailed Work Activities

• Treat patients using alternative medical procedures.
• Follow protocols or regulations for healthcare activities.
• Record patient medical histories.
• Analyze test data or images to inform diagnosis or treatment.
• Develop treatment plans that use non-medical therapies.
• Collect medical information from patients, family members, or other medical professionals.
• Evaluate patient outcomes to determine effectiveness of treatments.
• Prescribe treatments or therapies.
• Advise patients on effects of health conditions or treatments.
• Examine patients to assess general physical condition.
• Train patients, family members, or caregivers in techniques for managing disabilities or illnesses.
• Prepare medications or medical solutions.
• Evaluate treatment options to guide medical decisions.
• Treat patients using physical therapy techniques.

Work Context

• Contact With Others — 87% responded “Constant contact with others.”
• Freedom to Make Decisions — 88% responded “A lot of freedom.”
• Physical Proximity — 82% responded “Very close (near touching).”
• Structured versus Unstructured Work — 70% responded “A lot of freedom.”
• Face-to-Face Discussions — 79% responded “Every day.”
• Importance of Being Exact or Accurate — 58% responded “Extremely important.”
• Exposed to Disease or Infections — 71% responded “Every day.”
• Telephone — 54% responded “Every day.”
• Indoors, Environmentally Controlled — 84% responded “Every day.”
• Electronic Mail — 58% responded “Every day.”
• Deal With External Customers — 39% responded “Extremely important.”
• Frequency of Decision Making — 50% responded “Every day.”
• Spend Time Using Your Hands to Handle, Control, or Feel Objects, Tools, or Controls — 47% responded “Continually or almost continually.”
• Work With Work Group or Team — 33% responded “Extremely important.”
• Impact of Decisions on Co-workers or Company Results — 30% responded “Important results.”
• Letters and Memos — 56% responded “Once a week or more but not every day.”
• Spend Time Standing — 46% responded “More than half the time.”
• Coordinate or Lead Others — 25% responded “Extremely important.”
• Responsible for Others' Health and Safety — 37% responded “Moderate responsibility.”
• Time Pressure — 26% responded “Every day.”

Acupuncturists are skilled health care providers and when compared to similarly situated professions identified by the Specific Vocational Preparation as a component of Worker Characteristics information found in the Dictionary of Occupational Titles (U.S. Department of Labor, 1991).

SVP is the amount of time needed to learn the techniques, acquire the information, and develop the facility for average performance in a specific job-worker situation. SVP comes from vocational education, civilian, military, and institutional work experience, apprenticeship, and from in-plant and on-the-job training.

Level Time

1. Short demonstration only
2. Anything beyond short demonstration up to and including 1 month
3. Over 1 month up to and including 3 months
4. Over 3 months up to and including 6 months
5. Over 6 months up to and including 1 year
6. Over 1 year up to and including 2 years
7. Over 2 years up to and including 4 years
8. Over 4 years up to and including 10 years
9. Over 10 years

• Related Occupations SVP Scores

Acupuncture Registration

GENERAL INFORMATION

Among other things, doctors of chiropractic are authorized to perform rehabilitative therapies which may be done to prepare a patient for chiropractic adjustment or complement the chiropractic adjustment. Examples of rehabilitative therapies are heat, ice, water, exercise, nutrition and meridian therapy. Meridian therapy includes, among other things, acupuncture. However, before a doctor of chiropractic can perform acupuncture, they must be properly registered with the Board.

In 1995, a new statute was enacted regarding acupuncture. This statute was designed to apply to all other persons who were engaging in the practice of acupuncture, requiring them to become registered with the Board of Medical Practice. This statute specifically exempted doctors of chiropractic from this registration requirement, provided they were properly registered under the Board of Chiropractic Examiners, and that they were using the acupuncture to prepare the patient for chiropractic adjustment or complement the chiropractic adjustment. Any doctor of chiropractic who wishes to perform acupuncture without also providing chiropractic care to a patient, may do so provided they are appropriately registered under the Board of Medical Practice.
APPLICATION PREREQUISITES

A doctor of chiropractic wishing to become registered to perform acupuncture in conjunction must submit an Acupuncture application. An application may be acquired though this website or by calling the board office at (651) 201-2850.

In order for a doctor of chiropractic to be eligible to perform acupuncture in conjunction with their practice, they must show evidence of 100 hours of acupuncture related education consisting of at least 85% classroom/hands-on, or submit an affidavit stating that they have a specified amount of education and experience. In addition, they must pass the Acupuncture Examination administered by the National Board of Chiropractic Examiners, or the examination administered by the National Certification Commission on Acupuncture and Oriental Medicine (NCCAOM). For more information please see Minn. R. 2500.3000, Subd.2.

https://mn.gov/boards/chiropractic-examiners/licensee/acupunctureregistration.jsp

Application of Rehabilitative Services for Chiropractors

Questions have come up recently about the connection between chiropractic care and therapies commonly referred to as “rehabilitative” or “adjunctive” therapies. These may include, by way of example, ultrasound, cryotherapy, nutritional counseling, acupuncture (for those properly registered), exercise, traction, or other similar therapies, as described in more detail at https://www.revisor.leg.state.mn.us/rules/?id=2500.0100.
Minnesota Statutes states that these therapies must be used to: “...prepare the patient for chiropractic adjustment or to complement the chiropractic adjustment. The procedures may not be used as independent therapies or separately from chiropractic adjustment.” [ https://www.revisor.mn.gov/statutes/?id=148.01 ] The Board does not interpret this statute to mean that such therapies must be delivered on the same day as an adjustment, or even by the same chiropractor who delivered the adjustment. In fact, there are occasions when delivering such a therapy on the same day as the adjustment may be dangerous to the patient, and it is up to the doctor to utilize careful clinical judgment when utilizing rehabilitative therapies proximate to the delivery of chiropractic care. Doctors are reminded, however, that they may be required to defend such decisions before the Board when the delivery of such therapies is so remote in time or relation to chiropractic adjustment that a clinical connection becomes difficult to determine.

https://mn.gov/boards/chiropractic-examiners/currentissues/#App%20rehab

Acupuncturists when providing care for Medicaid recipients.

Minnesota Medicaid has covered acupuncture for chronic pain for over 20 years. The first policy of coverage including acupuncture for chronic pain allowed providers that were physicians who provided acupuncture and acupuncturists who worked under a physician licensed as a physician extender. The language was changed with a federal waiver to include all provider types who provide acupuncture in Minnesota to include physicians, chiropractors who use acupuncture as adjunct to the manipulation and are registered to provide acupuncture and licensed acupuncturists.

Acupuncture coverage was expanded to include care for the following conditions:

• Acute pain
• Chronic pain
• Depression
• Anxiety
• Schizophrenia
• Post-traumatic stress disorder
• Insomnia
• Smoking cessation
• Restless legs syndrome
• Menstrual disorders
• Xerostomia (dry mouth) associated with:
• Sjogren’s syndrome
• Radiation therapy
• Nausea and vomiting associated with:
• Post-operative procedures
• Pregnancy
• Cancer care

https://www.dhs.mn.gov/main/idcplg?IdcService=GET_DYNAMIC_CONVERSION&RevisiionMethod=LatestReleased&dDocName=DHS16_166324

Acupuncturists are also identified to provide to Medicaid patients the following as a physician extender:
Education or counseling is the primary reason for the visit:
services to healthy individuals for the purpose of promoting health and anticipatory guidance (i.e., family planning, smoking cessation, infant safety, etc.).
Education or counseling is the primary reason for the visit: services to people with symptoms, a diagnosis or an established illness (i.e., prenatal, joint care, pain, HIV, asthma).
Refer also to nutritional, diabetic and weight reduction guidelines.
https://www.dhs.mn.gov/main/idcplg?IdcService=GET_DYNAMIC_CONVERSION&RevisiionMethod=LatestReleased&dDocName=ID_008926

Physician Extenders in Minnesota Medicaid

MHCP covers health services provided by a physician extender under the supervision of the physician. Physician extender services are not covered unless they replace or substitute for the physician service.

Physician Extender: PA or APRN who chooses not to enroll with MHCP, genetic counselor, registered nurse, licensed acupuncturist or pharmacist who is in one of the following professional environments:

• Employed by the physician provider
• Employed by the same provider organization that employs the physician
• Supervised by a physician

Scope of the study for chronic low back pain

While I appreciate that we are starting somewhere to study acupuncture for chronic low back pain. I would like to see studies on acupuncture treatment to include all forms of chronic pain, acute pain, spinal pain and postlaminectomy syndrome/failed back syndrome. While starting with low back pain is a good start what about those that suffer from acute low back pain or low back pain that a patient ends up in the emergency department? Let alone the list of all other types of chronic, acute or emergency pain. Minnesota has done studies in the emergency department that looked at acute pain and found that acupuncture can reduce pain and the anxiety in the emergency department setting and can sometimes outperform iv morphine. Current hospital coverage under Medicare I do not believe will cover acupuncture.

If you look at Local Coverage Determinations for example National Government Services L33622 Pain Management uses research supporting documents that support acupuncture treatment. I have also noticed many of the documents and research are not exclusive to the Medicare age category. I have also looked at a few other coverage determinations for both LCD and NCD that use data and supporting documents that are not totally inclusive of those Medicare beneficiary age category.

I would encourage LCDs to support acupuncture as well for all forms of chronic pain, acute pain, spinal pain and postlaminectomy syndrome/failed back syndrome both in outpatient, in patient and emergency departments. LCDs were defined in the Social Security Act Section 1869(f)(2)(B) which states “the term ‘local coverage determination’ means a determination by a fiscal intermediary or a carrier under part A or part B, as applicable, respecting whether or not a particular item or service is covered on an intermediary or carrier-wide basis under such parts, in accordance with section (a)(1)(A).” In other words, the LCD identifies if and when a service is reasonable and necessary. The contractor communicates specific covered and non-covered diagnoses in the LCDs Medicare Contractors are also given the discretion of determining any additional benefits that will be covered at the local level beyond what is already required based on NCDs. The additional benefits for services and items, and the terms by which such service will be considered reasonable and necessary, is communicated via LCDs. LCDs can address coverage requirements for items for services for which there is no NCD. The topics and coverage requirements may vary from contractor to contractor. Minnesota Medicaid covers acupuncture for a number of conditions.

Many guidelines include acupuncture as part of pain management strategies. In the draft for the CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 I submitted a document of the current guidelines that recommend acupuncture. If you would like a copy I can provide you a copy. Currently there are many workers compensation insurance that cover acupuncture and are part of guidelines for other types of pain. Please allow those to be included in your evidence of care.

I request also that the scope of the study to include Medicare beneficiaries that are 55 years old that are disabled due to chronic pain and are covered under the social security disability act.

Medicare Coverage Guideline for Chronic Low Back Pain

I am interested in seeing what the current coverage of care is provided for those Medicare beneficiaries for the treatment of chronic low back pain. I would like Medicare to provide a comprehensive guideline for beneficiaries for all chronic pain as well. When developing comprehensive coverage statements based on scientific evidence and peer review guidelines and research articles it is important to know what is currently covered.

As an acupuncturist I do not know what the current coverage is for chronic low back pain. How do we know where we are and where we want to go to improve health care delivery when we do not have our arms wrapped around what we have done and where we have to improve outcomes. In an article by Washington post they have identified injections, braces, implanted neurostimulators, and chiropractic care as well as drugs for chronic low back pain. I would like to think physical therapy is included which many physical therapist use things like manual therapy and massage in their treatment protocols. But currently I do not know what is covered.

I like that the Medicare wants to identify research and guidelines that support acupuncture in this special population. I would also like the Chronic Low Back Pain guideline coverage to discuss research that is specific to this population and the risks associated with this population. This population is at greater risk when it comes to pharmacological management of care. There are some guidelines that identify the risks. For example the Institute for Clinical Systems Improvement have created a Guideline for Low back pain; Adult Acute and Subacute. In this guideline they have a special discussion of this population for example:

Skeletal muscle relaxants:
Skeletal muscle relaxants are better than placebo but not more effective than NSAIDs in the treatment of low back pain. Sedative hypnotics are effective for treating anxiety and muscle spasms in acute pain.

Harm:

Muscle relaxants are central nervous system (CNS) depressants and cause additive sedation and other adverse effects, especially in combination with opioids. Sedative hypnotics have significant side effects, specifically in the geriatric population. Additive side effects when taken with other CNS depressants are potential for dependence and withdrawal symptoms.

Opioids:

Geriatric patients should be assessed for risk of falls, cognitive decline, respiratory malfunction, and renal malfunction before receiving opioids.

If impairment or risk is detected in a geriatric patient, consider reducing the initial opioid dose by at least 50%.

Benefit:

Doing a unique assessment for geriatric patients is important because of this group’s unique vulnerabilities. Lowering the dose of opioids may lower the risk of opioid-related harm, such as falls and respiratory suppression, in this population.

Harm:

Geriatric patients are a diverse group of patients, some more fragile and others more robust. They should not be treated as having equal risk of opioids as a group. The most fragile geriatric patients may also have contraindications to the common alternatives to opioids. This may lead to undertreatment of pain.

Benefit-Harms Assessment: Like many of the high-risk populations, using special precautions and lower doses in the geriatric population lowers the risk of opioid-related harms while also risking undertreating pain.

Patients on acute dosing of opioids are at an increased risk from falls and other accidental trauma. This is particularly so for geriatric patients. Opioids should be used cautiously for patients with past falls or at an increased risk of fracture. Some guidelines suggest prescribing half the normal initial dose when treating the elderly. Other CNS depressants such as anticholinergic medications, alpha adrenergic blockers and benzodiazepines will compound the risk of falls and fractures in patients on opioids.

Opioids can precipitate delirium in some patients. Those with significant risk factors for opioid-induced delirium include the elderly patients with cognitive impairments, polypharmacy, advanced liver or kidney disease, and patients with prior episodes of delirium precipitated by opioids. Consider these factors when dosing opioids, and educate the patient and his or her family of the risks (Manchikanti, 2012a).

Other medications have been identified as a risk for those in the Medicare beneficiary age group.

NSAID:

In a review of NSAID’s A Comprehensive Review of Non-Steroidal Anti-inflammatory Drug Use in The Elderly by Supakanya Wongrakpanich, , Amaraporn Wongrakpanich, Katie Melhado, Janani Rangaswami they identified the following but they also discuss the increased risk of falls with these medications.

Table 1. NSAIDs’ common adverse effect profile.

Gastrointestinal toxicity • Dyspepsia • Gastroduodenal ulcers • GI bleeding and perforation
Cardiovascular adverse effects • Edema • Hypertension • Congestive heart failure • Myocardial infarction • Stroke and other Thrombotic events
Nephrotoxicity • Electrolyte imbalance • Sodium retention • Edema • Reduce glomerular filtration rate • Nephrotic syndrome • Acute interstitial nephritis • Renal papillary necrosis • Chronic kidney disease

I believe that patients deserve to know the options available and the risks. I am hoping that the risks for acupuncture are also part of the discussion. Many patients are on blood thinners. I have had some doctors okay with acupuncture as long as we use precautions and others that are absolutely no. There are some aggressive needling techniques and less aggressive that do not cause much problems. But the risks are real but the benefit for some are greater.

In the last year I have been reviewing different pain guidelines, articles about insomnia, restless leg syndrome, and anxiety and depression. Part of some of these guidelines they have identified malnutrition as a potential cause or result of the condition. I would like to see patients in this population have risk assessments done regarding iron deficiency, iron excess, b12, vitamin d and thyroid disorders. I have found articles that looks at chronic kidney disease, chronic heart failure and inflammatory bowel disease that indicate iron regulation as a problem. There are articles that support b12 for those with diabetes on metformin and those with intestinal diseases. As we age we know that malnutrition is a possibility to changes in the body. Do these put this age group more at risk for chronic pain? Please if you wish to review some of the articles I have reviewed I would be willing to share.

While I support pharmacological approaches to manage pain we know that this population is at greater risks due to polypharmcology and how drugs respond in the body putting them at greater risk to harm.

Acupuncture is used to treat local areas of pain and to treat system imbalances. I would like the acupuncture studies to explain whether it is a local area treatment or is a system treatment. There are different ways in which to treat using acupuncture. Identifying acupuncture treatments as local area treatment or systemic treatment would be helpful as part of the discussion.

So for example one of the management of pain is the use of oral steroids to reduce the pain and inflammation and another strategy could be to do a local injection of a steroid. Acupuncture can be used in both capacities to influence pain.

One of the systemic benefits is that pain can have an impact on quality of life factors for example sleep, stress, energy, digestive disorders and menstrual irregularities. Acupuncture can be used to influence these disorders that are often present in patients that are experiencing pain whether it is a result of pain management pharmacy or because of the pain syndrome. Sometimes a systemic treatment to help in these quality of life factors results in a reduction of pain and improved quality of life.

I would also like to know if part of the study will discuss the tissue and how it feels. As a previous massage therapist I have had the opportunity to feel tissue in its different states. Areas of pain will often have a change in the tissue composition. I will often feel the tissue before treatment and then after the needles are pulled I will feel to see if the tissue changes and often it does. Using acupressure point’s tenderness and texture before and after treatment would be a good tool to use as well.

Thank you for considering my thoughts on the subject.

Sincerely,

Bonnie M. Abel Bolash, M.Ac., L. Ac.
Licensed Acupuncturist

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Hello,

Your proposed document would allow certain non-acupuncturists to provide acupuncture services. Non acupuncturist do not have the level of training of licensed acupuncturists, particularly in the state of California where the standards are quite high.

It excluded California licensed acupuncturists who have not also been certified by the NCCAOM. California licensure is equivalent to the NCCAOM, even by NCCAOM standards.

It labeled licensed acupuncturists as "auxiliary personnel", and

It initiated support for supervision of acupuncturists by physician assistants, nurse practitioners and/or clinical nurse specialists. Licensed acupuncturist should have the authority to practice what is within their scope of practice as it is in the state of California without oversight by other health professionals who are not skilled and trained in the same manner as licensed acupuncturists. This de-values acupuncturists' training and give extra unjust authority to other entitities.

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I write to express my solidarity with the points expressed in the letter of August 4, 2019, by the California Acupuncture and Traditional Medicine Association (CalATMA) regarding the study of the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As the proposal is written:

Thank you for addressing our concerns as professional licensed acupuncturists in the state of California.

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I work entirely with insurance patients. Because these companies have determined the limited scope of conditions they deem acupuncture useful for, I treat neck and backpain, often chronic, every day. I use bio-mechanical principles to address muscle imbalance and misfiring muscles that restrict range of motion and create pain feedback loops to the brain. Some patients are relieved immediately. But I treat quite a few who will never be without pain, and have been on heavy opioids, steroids, muscle relaxers, etc and even psych meds to deal with the inevitable mental suffering that comes with chronic pain. They love what I do. They keep coming back! A piano teacher I'll see this afternoon is thrilled his discomfort is down to 40% of what it was, and we've maintained that after a steady reduction of the worst pain! The only problems I see are that acupuncture is not known to enough people and that insurance companies often limit the number of visits that chronic pain patients may receive.

I implore you to recognize Acupuncture and Chinese Medicine as valuable remedies for not only chronic pain, but a host of other common medical complaints.

Sincerely.

Andrew C Whitelaw, LAc

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August 14, 2019
The Honorable Seema Verma
Administrator, Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: U.S. Pain Foundation Supports Proposed Decision Demo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Administrator Verma,

The U.S. Pain Foundation is a 501(3)(c) nonprofit organization that seeks to empower, educate, support, and advocate for the 50 million Americans who live with chronic pain. We support the Centers for Medicare & Medicaid Services’ (CMS) proposal to provide coverage for acupuncture for chronic low back pain (CLBP) to certain Medicare enrollees. U.S. Pain encourages public and private payer coverage of acupuncture to treat CLBP, and urges CMS to consider offering coverage to beneficiaries living with all diseases and conditions which cause chronic pain.

U.S. Pain believes in a balanced approach toward combating the twin crises of opioid abuse and misuse and chronic pain. The goals of an appropriate pain management plan should be to decrease pain and suffering, improve physical and mental functioning, and ensure improved quality of life. Increasing access and coverage of various modalities, including acupuncture, may, in addition, decrease overall medical expenses and costs to both enrollees and Medicare health plan programs. Our organization further supports an integrative and individualized approach to chronic pain management as recommended by the U.S. Department of Health and Human Services’ Pain Management Best Practices Interagency Task Force convened as part of the Comprehensive Addiction and Recovery Act (CARA).

Today, integrative approaches are being used for pain management for military personnel and veterans, symptom management in cancer patients and survivors as well as in the area of health-related behaviors. For example, the U.S. Department of Veterans Affairs (VA) medical centers and hospitals were mandated to have access to acupuncture, in addition to other complementary and integrative therapies by October of 2018. This mandate stems from results of evidence-based review by the Integrative Health Coordinating Center (IHCC) within the VA’s office of Patient Centered Care and Cultural Transformation.

Outside of the VA utilizing integrative pain management therapies for vulnerable patient populations, the American College of Physicians’ (ACP) low back pain treatment guideline cites heat therapy, massage, acupuncture and spinal manipulation as noninvasive, non-drug options for low back pain treatment. The National Academy of Sciences, Engineering, and Medicine’s Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use Consensus Study Report published in 2017 noted that “nonpharmacologic interventions for pain treatment, including acupuncture, physical therapy and exercise, cognitive behavioral therapy and mindfulness meditation, also are powerful tools in the management of chronic pain”.

With integrative and complementary therapy options receiving such wide recognition as a beneficial option for many Americans diagnosed with varied chronic pain conditions, U.S. Pain Foundation encourages CMS to endorse acupuncture as a valid treatment option for chronic low back pain. We recognize that low back pain is one of the most common causes of chronic pain, with millions of Americans experiencing low back pain at any given time, which is why the organization believes it is important for payers to cover acupuncture and other therapies not currently covered to help maintain overall daily function.

U.S. Pain Foundation encourages CMS to also consider the unique needs of individuals with various chronic pain conditions enrolled within Medicare. We know that there is no “one-size-fits-all” solution to manage chronic pain. That being said, providing opportunities for the millions of Americans riddled with pain to have access to alternative management options, such as acupuncture, may reduce pain levels and enhance a person’s overall quality of life. Opening access to acupuncture and other integrative pain treatments may also decrease the financial burdens many families and individuals experience due to missed work and high cost of health care premiums.

On behalf of those Medicare enrollees living with chronic low back pain and other, equally challenging pain conditions, U.S. Pain Foundation respectfully requests that CMS move forward with its proposed decision to provide coverage of acupuncture to chronic low back pain enrollees who meet the proposal’s criteria, but also open up coverage of acupuncture to all beneficiaries living with chronic pain conditions.

Respectfully submitted,
Nicole Hemmenway
Interim CEO, U.S. Pain Foundation

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Hello,

CMS proposes to study acupuncture for chronic low back pain, but DOES NOT MENTION Licensed Acupuncturists explicitly.

Here's a summary of my main concerns:

• The proposed document would allow certain non-acupuncturists to provide acupuncture services,
• It excludes California licensed acupuncturists who have not also been certified by the NCCAOM,
• It labels licensed acupuncturists as "auxiliary personnel", and
• It initiates support for supervision of acupuncturists by physician assistants, nurse practitioners and/or clinical nurse specialists.

Licensed acupuncturists should be included in this study, the California Acupuncture Licensing Exam to be equivalent to the NCCAOM exam for the purposes of this study, and licensed acupuncturists need to be recognized as independent practitioners, without the need for supervision by physician assistants, nurse practitioners, and/or clinical nurse specialists.

Best,

Nicolette

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Thank you for taking the time to hear our thoughts about acupuncture. As an Office Manager of an acupuncture practice, I see copious amounts of senior citizens who want to get acupuncture desperately but cannot afford it. We have kept so many patients from needing surgery just with acupuncture. If you look at the reimbursement that Carefirst pays, 15 visits would cost the insurance company $1188.75 vs the $50-1000k it costs for the surgery. By offering acupuncture, it will save Medicare millions of dollars.

A licensed acupuncturist is the most qualified practitioner for the covered practice as they have a Masters Degree and 1500-2000+ practice hours even before becoming an acupuncturist. However, when performing the study, it is imperative that an MD oversee the trials.

[PHI Redacted]

I have seen patients barely walk into the office and feel much better when leaving. When people call and are upset that they cannot come because Medicare does not cover, it breaks my heart. If they can get a affordable treatment that does not lead to opioids or surgery, then it is a perfect scenario. And honestly, if acupuncture does not work for them in about 4-5 visits, they will not continue to come. So there would not be any wasted funds unless a practitioner would tell them to keep coming like a chiro or PT would.

I cannot express how important this is to the senior community to assist in relieving their pain. I truly hope that you will consider the coverage for Medicare.

Thank you so much for your time.

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

July 24, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

As a Member of the Acupuncture Society of New York (ASNY) and the American Society of Acupuncturists, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As my colleagues in the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

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America’s Health Insurance Plans (AHIP) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) national coverage analysis for acupuncture for chronic low back pain.

AHIP is the national association whose members provide coverage for health care and related services. Through these offerings, we improve and protect the health and financial security of consumers, families, businesses, communities and the nation. We are committed to market-based solutions and public-private partnerships that improve affordability, value, access, and well-being for consumers.

We commend CMS for their decision to cover acupuncture for chronic low back pain for Medicare beneficiaries when enrolled in appropriate studies. We agree this is the right approach given the current evidence base.

We would like to highlight some of the research gaps that exist as it relates to chronic low back pain which were included in our comments submitted to you in February of this year, including for example:

Additionally, we commend CMS for outlining appropriate training requirements that physicians, physician assistants, nurse practitioners/clinical nurse specialists, and auxiliary personnel must meet if they intend to furnish these services. The risks of acupuncture are relatively low when services are delivered by a certified provider.

Again, we thank CMS for reviewing this issue. We would be happy to answer any questions you may have.

Thank you,

Kate Berry
Senior Vice President for Clinical Affairs & Strategic Partnerships

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The Physical Medicine Management Alliance (PMMA) of the National Association of Specialty Health Organization (NASHO) appreciates the opportunity to comment on Proposed Decision Memo on Acupuncture for Chronic Low Back Pain.

NASHO is one of the nation’s only organizations solely focused on fully integrating specialty health into the healthcare reimbursement model. PMMA’s mission is to promote the value of physical medicine and integrative healthcare in generating quality outcomes by advocating for increased access, facilitating collaboration with specialty providers, and enhancing patient choice.

PMMA supports evidence-based pain management for musculoskeletal disorders (MSDs) and advocacy for non-pharmacologic approaches to care, such as acupuncture, chiropractic care, physical therapy, massage therapy, and exercise therapy. These options play an important yet underutilized role in pain management. For many reasons, they are a safer alternative to opioids or other higher risk medical procedures.

While we appreciate the agency has taken the first step in providing coverage for acupuncture and understand that the proposed coverage decision is limited to clinical trials, we are concerned that the limitations outlined in the proposed decision memo will prevent most seniors from receiving the benefit of this effective non-pharmacologic, non-invasive option for pain management.

More health plans, including Medicare Advantage plans, are covering acupuncture as a treatment for chronic pain. PMMA believes there is sufficient evidence to support the decision to cover acupuncture as a “reasonable and necessary” treatment for low-back pain. In a review of multiple studies published in the Journal of the American Medical Association (JAMA), acupuncture was shown to reduce pain for a variety of conditions by 50 percent compared to sham (i.e., placebo)-acupuncture or no-acupuncture control groups (Vickers et al., 2014). Another study looked at acupuncture provided in the emergency department and found improved patient outcomes with the use of treatment method (Reinstein et al., 2016) While the study looked at a broader set of conditions beyond low-back pain it found a 38 percent decrease in pain. A 2007 study found a 33 percent improvement of lumbago with acupuncture at a six-month follow-up (Haake et al., 2007). The American Pain Society has also acknowledged that acupuncture is a reasonable treatment option for patients with chronic pain (Vickers et al., 2018).

Limited access to integrative healthcare (IH) providers who specialize in physical medicine and musculoskeletal care inhibits Medicare beneficiaries’ ability to seek alternatives beyond opioids. There are evidence-based guidelines and best-practice IH approaches inclusive of the Medicare population coupled with a growing body of evidence that supports the efficacy and effectiveness of these types of conservative treatment approaches. Musculoskeletal disorders affect one in two adults and costs billions each year. Increased access to IH can help address those costs as well as costs associated with the opioid crisis.

Thousands of Americans suffering from MSDs have been caught up in the nation’s opioid epidemic because they were not offered non-pharmacological treatment options as first-line therapy. PMMA believes expanding coverage for acupuncture would help to eliminate one of the barriers in Medicare to access IH. We applaud CMS’s proposed coverage decision which is a step closer to providing comprehensive access to care for seniors suffering from chronic pain. PMMA would welcome the opportunity to provide additional input and recommendations to CMS regarding considerations for benefit design; i.e. visit limits, copays, covered procedures, reimbursement limitations, clinical oversight, etc.

We appreciate the opportunity to provide feedback to CMS’ Coverage and Analysis Group (Group) and look forward to the final coverage decision.

Works Cited:

Vickers, A., Linde, K (2014). Acupuncture for Chronic Pain. JAMA. 311(9):955-956. https://jamanetwork.com/journals/jama/fullarticle/1835483

Reinstein AS, Erickson LO, Finch MD, Rivard RL, Kapsner CE, Dusek JA. (2016). Acceptability and Clinical Outcomes of Acupuncture provided in the Emergency Department: A Retrospective Pilot Study. Pain Med; pnv114 DOI: http://dx.doi.org/10.1093/pm/pnv114

Haake M., et al. (2007). German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med; 167(17):1892-8 https://www.ncbi.nlm.nih.gov/pubmed/17893311

Vickers, A, et al. (2018). Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. The Journal of Pain, Vol 19, No 5 (May), 2018: pp 455-474. https://www.jpain.org/article/S1526-5900(17)30780-0/abstract

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14, August, 2019

The Acupuncture Society of MA would like to thank the CMS for your consideration of this topic. It is important that a health care service used by so may patients that is provided by Licensed acupuncturists who have been trained, vetted and licensed to practice be able to provide the service they have trained for many years, typically 6-8 to provide care for patients.

To practice acupuncture in MA one must have at least 60 hours of undergraduate education and to have graduated from an ACAOM accredited acupuncture institution with a minimum of 1,905 hours of didactic/clinical education with at least 210 clinical hours in acupuncture and to have passed four national psychometric exams and obtain NCCAOM Certification. There is NO supervision requirement by a medical doctor to practice as a licensed acupuncturist in the Commonwealth of MA.

We urge you to include “Licensed Acupuncturists” under “auxiliary providers” because that is who we are and what we have been trained and licensed to do.

We ask that supervision provided during this study be done by MDs only. Supervision by other licensure types has no precedent in these kinds of studies and in no way adds to the safety or quality of the trials.

Please let us know how we can support this ongoing effort.

The ASM Board of Directors

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I support Medicare/Medicaid Coverage of acupuncture treatments for people who suffer from chronic low back pain.

Like many of my colleagues, I practice acupuncture in a low cost/high volume Community Acupuncture clinic and I have been licensed for 13 years. Low back pain is hands-down the most common reason why patients seek acupuncture, and these patients constitute a majority of our entire patient base. I always tell them "If we couldn't treat low back pain, we'd be out of business."

Acupuncture can be used on its own or in conjunction with other kinds of pain treatments or medications, such as cortisone injections. Many of my patients have been able to reduce their medication when they have access to frequent and regular acupuncture treatments Some have been able to wean their opioid medications entirely after getting regular acupuncture

If Medicare/Medicaid should cover acupuncture for those with chronic low back pain, it makes sense that your agency would work with all licensed acupuncturists. If they have a valid state license, then they are qualified. Please do not limit this only to acupuncture practitioners who maintain national certification with the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). Every licensed practitioner takes the NCCAOM board exam or the very similar California exam. There is no difference in the quality of care that comes from acupuncturists who pay to keep their national certification and those who do not.

I would also like to submit that the Centers for Medicare and Medicaid Services should consider creating billable codes to cover auricular acupuncture for the treatment of Substance Use Disorder, Trauma, and all issues related to behavioral health. SAMSHA recognizes ear acupuncture as a treatment for SUD in TIP 45 and half of the states in the US allow for non-acupuncturist health providers and lay practitioners to practice ear acupuncture if they are certified by the National Acupuncture Detoxification Association or equivalent training.

Thank you for considering this comment.

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I am member of CalATMA, we have these concerns:

We do not know the concern(s) that led CMS to not explicitly mention licensed acupuncturists as personnel permitted to furnish acupuncture in these trials. We offer the following information, in the hopes that it will help address whatever the concern(s) might be:

The requirements for licensure and bi-annual recertification are essentially identical to all other health we request that CMS revise the Proposed Decision Memo to:

• Explicitly list licensed acupuncturists (or state equivalents) who carry an active and unrestricted license in their state of practice as providers of acupuncture;
• Remove reference to "auxiliary personnel" as providers of acupuncture; and
• Remove the requirement for supervision by physician assistants or nurse practitioner/clinical nurse specialists.

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As a Member of the Association for Professional Acupuncture in Pennsylvania and the American Society of Acupuncturists, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As my colleagues in the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

In the state of Pennsylvania, Licensed Acupuncturists formerly were under physician-supervision until 2002 and then required to have physician-referral until 2006. The current Pennsylvania statute can be found here: https://www.pacode.com/secure/data/049/chapter18/subchapbtoc.html

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely.

Jeremiah Fan

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August 14, 2019

Dr. Susan Miller
Mr. David Dolan
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

To Dr. Miller and Mr. Dolan,

On behalf of Allina Health and its Penny George Institute for Health and Healing, I want to thank the Centers for Medicare and Medicaid Services (CMS) for its further interest in the effects of acupuncture to treat chronic low back pain in populations covered by Medicare and appreciate the opportunity to comment on the National Coverage Analysis for Acupuncture for Chronic Low Back Pain (CAG-00452N). Allina Health is dedicated to the prevention and treatment of illness and enhancing the greater health of individuals, families and communities throughout Minnesota and western Wisconsin. A not-for-profit health care system, Allina Health cares for patients from beginning to end-of-life through its 90+ clinics, 11 hospitals, 15 pharmacies, specialty care centers and specialty medical services that provide home care, senior transitions, hospice care, home oxygen and medical equipment, and emergency medical transportation services. Allina Health’s Penny George Institute, created in 2003, is the country’s largest integrative health center embedded in a health system.

Allina Health and the Penny George Institute believe that there is evidential proof to support Medicare coverage of acupuncture for chronic low back pain. We have included several resources for review that support our comments below. We also support the comments submitted by the American Society of Acupuncturists and the Minnesota Acupuncture Association.

First, research has shown that acupuncture is an effective intervention for chronic low back pain in Medicare-eligible populations, as well as in the population in general. Please see references #4, #5 and #8 for complete details.

Second, acupuncture can safely reduce opioid medication use, as was shown by a study of a military patient population which reduced their opioid prescriptions by 45% after providing a course of acupuncture treatments. In another study, acupuncture outperformed intravenous morphine for pain control in an ED setting. The Joint Commission listed acupuncture as an evidence-based, non-opioid option for pain. Please see references #2, #3 and #14 for complete details.

Third, two studies conducted in the UK showed that acupuncture is a cost-effective alternative to conventional care. In Minnesota, the Department of Human Services determined acupuncture to be a medically- and cost-effective treatment for chronic pain and includes it in the benefit set for Medicaid and MinnesotaCare when provided by a licensed acupuncturist or by another Minnesota licensed practitioner for whom acupuncture is within the practitioner's scope of practice and who has specific acupuncture training or credentialing. Additionally, the U.S. Veterans Health Administration (VHA) created two distinct professions of licensed acupuncturists, creating cost savings for the delivery of acupuncture and increasing utilization of acupuncture among veterans. Historically, acupuncture was provided in the VHA mostly by physician–acupuncturists and chiropractic. Please see references #1, #9, #11 and #12 for complete details.

Fourth, acupuncture has been shown to be more effective than a placebo. As stated in the conclusion of Vickers et al., one of the largest and most comprehensive meta-analyses available addressing the effect of acupuncture on chronic pain, including chronic low back pain, acupuncture performed better than sham acupuncture by a statistically significant amount. In 2018, the study was updated to determine the effect size of acupuncture for 4 chronic pain conditions, including chronic low back pain. The study found clear evidence that the effects of acupuncture persist over time with only a small decrease, approximately 15%, in treatment effect at 1 year. Please see reference #7 and #10 for complete details.

Finally, acupuncture is one of the current recommendations for chronic low back pain from the American College of Physicians. Acupuncture has proven to be an effective, affordable and safe non-pharmacological method of pain management that physicians are actively recommending to their patients. Please see reference #6 for complete details.

Appropriate acupuncture clinicians and training requirements
Allina Health urges CMS to update Medicare statute by replacing “auxiliary personnel” with “licensed acupuncturists or state equivalent.” The qualifications for auxiliary providers exactly describe this licensure group – a masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM); a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and maintained licensure in a U.S. state or territory to practice acupuncture. In 2017, the U.S. Bureau of Labor Statistics (BLS) established an independent standard occupational code (SOC-29-1291) for acupuncturists. Please see references #13 and #15 for complete details.

The need for direct supervision by a physician during trial is understandable; however, it is inconsistent with every state law that licensed acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Allina Health asks that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist.”

Allina Health thanks CMS for the opportunity to share our comments on the continued coverage consideration of acupuncture for chronic low back pain. Our organization hopes to see a new coverage determination in the future that is inclusive of the comments we have provided.

If you have any questions regarding these remarks, please feel free to contact me at Briana.NordParish@allina.com or (612) 262-6851.

Sincerely,

Briana Nord Parish
Manager, Federal Government Affairs

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As an acupuncturist in America, I believe that access to acupuncture should be possible for as many Americans as desire it. Therefore I applaud CMS's determination to explore acupuncture for low back pain in the population served by Medicare. I urge you to heed the suggestions of ASA regarding the language in your proposed research. Rather than "Physicians assistants...," I implore you to use the language: "Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture."

Additionally, please note that the placebo control of "sham acupuncture" is not a sound research tool in the practice of acupuncture. Acupuncture is a complicated procedure, and the majority of sham protocols fail to account for or control adequate aspects of the treatment. As a result, sham acupuncture is acupuncture, and comparing the two will result in poor outcomes in studies. Please refer to the 2011 SAR white paper by Langevin, Wayne, MacPherson et al, "Paradoxes in acupuncture research: Strategies for moving forward" in Evidence-Based complementary and Alternative Medicine Volume 2011 Article 180805 doi:10.1155/2011/180805 and to the 2013 meta-analysis of chronic pain trials by MacPherson, Maschino, Lewith, Foster, Witt, and Vickers "Characteristics of acupuncture treatment associated with outcome: An individual patient meta-analysis of 17,922 patients with chronic pain in randomized controlled trials" in PLOS one volume 8 issue 10 article e77438 for a profound discussion of the best practices in researching acupuncture according to the world's leading acupuncture researchers, the members of SAR, the Society for Acupuncture Research (www.acupunctureresearch.org)

Thank you for your time in reading this message. Thank you for your interest and work in increasing the range of access to our profession.

-Grace Ganel, M.Ac., L.Ac., CZB, ADS

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As a CA licensed Acupuncturist, I am very excited about our ability to practice in this arena. However, I strongly believe one should only be required to be CA licensed, and not also the NCCAOM license as well. As someone who sat for both exams, we are grateful to have the CA exam and license that is exceptionally thorough compared to the National accreditation.

Also, we are capable of practicing as independent medical practitioners, and the idea of requiring supervision by a PA or Nurse Practitioner is completely obstructionist to the flow of providing our care. It’s like the individual doesn’t know that in CA, we are primary care providers.

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I am a licensed acupuncturist with an active license in CO and and an inactive license in NY which can be reactivated upon request. My Masters degree inculded 3,000 didactic hours, approximately 1,500 in biomedicine and 1,500 in Traditional Chinese Medicine theory and application. In addition I had 1,000 of clinical training, in the student clinic and in a hospital setting at Lutheran in Brooklyn, NY, now a Langone NYU facility. In NY I worked in a private practice with a pain management specialist and at St. Vincent's Hospital off-site facility for pain managment. In CO, in addition to private practice I worked in Rose Hospital's Radiation Oncology department to help mitigate the side effects of radiation and chemotherapy as well as pre-surgery prep and post-surgery recovery.

Thank you for your consideration to include acupuncture in the treatment of low back pain. I would say a good 60% of what I see in my clinic is some type of joint pain with the low back being the most common. Indeed, I treat low back pain that has progressed to sciatica and neuropathies.

I am asking that the section that includes “auxiliary providers” be changed to more clearly named “Licensed Acupuncturists or state equivalent.” The qualifications for auxiliary providers accurately describe this licensure group.

Also, please have the supervisor to this study be an MD versus other licensed allied healthcare professionals. Supervision by other licensure types does not have a precedent, nor does it add in any way to the safety or quality of the trials.

I passed along the request for comments to my board, the AAC (Acupuncture Association of Colorado) as they would know the laws in CO to express to you we are well educated and have stringent requirements to attain licensure, and to keep it, getting recertified every 4 years.

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August 13, 2019
David Dolan
Susan Miller, MD
U.S. Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Mr. Dolan & Dr. Miller,

The Acupuncture Association of Colorado and our licensed acupuncturists thank you for efforts made on behalf of the Centers for Medicare & Medicaid Services (CMS) to study acupuncture for chronic low back pain in Medicare populations.

We thank you for the opportunity to provide acupuncture to Medicare patients who are participating in approved trials. As it stands, the language of the Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)¹ threatens to obstruct significant numbers of licensed acupuncturists from participating in current and future trials.

Our request is that the language of the proposed memo be updated:

• to include ‘licensed acupuncturists’
• and remove physician assistants, nurse practitioners/clinical nurse specialists, and auxiliary personnel, since acupuncture/dry needling are not within their scopes of practice.

Furthermore, it is appropriate to remove requirements for physician supervision. Acupuncture is a licensed profession that is regulated by legislation in 48 states and the District of Columbia.^2,3 In order to apply for licensure, the majority of states require that acupuncturists: graduate from an accredited graduate school, pass national or state examinations, and are certified in clean needle technique.^3,4 While numerous states require practitioners pass National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) examinations before applying for licensure, the majority do not require continued certification with this organization.^2,3 The state of California has the largest number of licensed acupuncturists of all of the United States and provides its own examination that is separate from the NCCAOM.^5,6 The NCCAOM currently represents 18,105 acupuncturists, but it is estimated that there are approximately 30,000-35,000 licensed acupuncturists in the United States.^4,7

We request that the requirement for current NCCAOM certification be removed and replaced with ‘licensed acupuncturist’ so that all qualified practitioners can deliver treatment to Medicare recipients. As it stands, not only does this requirement obstruct nearly half of our profession from administering treatment to Medicare recipients, it also obstructs the majority of providers in California State.^4-7

As determined by statutes and legislation across the nation, licensed acupuncturists have complete autonomy to administer acupuncture and to bill insurance without referral from the patient’s primary medical doctor.^3,5 We suggest that CMS develop framework that is similar to the US Department of Veterans Affairs (VA). The Standardized Episode of Care (SEOC) coverage defined by the VA allows covered individuals to receive 12 acupuncture sessions from licensed acupuncturists without any prior authorization⁸, and an additional 8 treatments for chronic conditions upon demonstrating continued improvement from the acupuncture treatment.⁹

The VA acupuncture coverage reimburses licensed acupuncturists, without any prior authorization for CPT codes that are specific to acupuncture (97810, 97811, 97813, 97814) and evaluation and management codes (99201-99205).^8,9 Looking forward, to keep acupuncture sustainable, we need to move towards increased reimbursement rates at a 10% rate annually for the above CPT codes for both Medicaid and Medicare.

Moving to cover acupuncture for Medicare patients with chronic low back pain represents a great accomplishment for patients looking to receive safe alternatives for pain management, and for practitioners who deserve to be reimbursed for their work. Thank you for considering our suggestions to ensure that licensed acupuncturists are correctly represented moving forward, and thank you for all of your work on this project thus far.

Sincerely,
Acupuncture Association of Colorado

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

July 24, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

As a Member of the Acupuncture Society of New York (ASNY) and the American Society of Acupuncturists, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As my colleagues in the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹ The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE).³ We propose alternate language for this section in toto that simply reads:

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile⁴ . In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

In the state of New York, this is the relationship required by statute between a Licensed Acupuncturist and Medical Doctors or Physicians: http://www.op.nysed.gov/prof/acu/acupunbroch.htm

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

The ASNY Board of Directors

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While I applaud your interest in studying the benefits of acupuncture, I believe a few changes need to be made in order to achieve the most accurate results. They are as follows:

1. Licensed Acupuncturists have the highest level of training in acupuncture and represent the majority of practitioners providing acupuncture in the United States. If you truly want to study the effectiveness of acupuncture it would behoove you to remove the designation of Licensed Acupuncturists as "auxiliary personnel" and to limit non-acupuncturists from providing acupuncture. That is the only way to measure the effectiveness of services the public will actually encounter.


2. The CALE(California Acupuncture Licensing Exam) to practice in California far exceeds the NCAAOM standards, please include CALE practitioners in the study. Otherwise, there is a risk of excluding over 10,000 acupuncturists from the study.


3. Supervision of Licensed Acupuncturists by less knowledgeable health care professionals will likely impede the accuracy of the study. Licensed Acupuncturists have significant training to determine issues such as needle placement and depth on their own. Creating a hierarchy with less trained individuals actually creates health risks for the patients. While other healthcare professionals may have knowledge of anatomy they are not trained in the safety of needle angles and depth at the various acupuncture points and parts of the body. Supervision for Licensed Acupuncturists is not needed as they have the highest level of training in acupuncture among all healthcare practitioners.

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RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

I am so grateful for the efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a Licensed Acupuncturist (L.Ac.) and soon to be Doctor of Acupuncture and Chinese Medicine (I currently hold the 4 years Master's degree after my B.S. in Neuroscience for undergraduate studies), I want to seek clarification on certain aspects of the decision memo recently issued.

The text of greatest relevance is highlighted below:

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE).

We propose alternate language for this section in toto that simply reads:

• Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

"Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist."

While I understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. I ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. I am delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment. Chronic low back pain is one of the most common things I personally treat in my clinic and the reduction of pain and quality of life improvement as a result of acupuncture are impressive in my experience.

Wishing you all the best,
Montana Burns, MSOM, LAc

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

July 24, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

As a Member of the Acupuncture Society of New York (ASNY) and the American Society of Acupuncturists, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As my colleagues in the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile . In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

In the state of New York, this is the relationship required by statute between a Licensed Acupuncturist and Medical Doctors or Physicians: http://www.op.nysed.gov/prof/acu/acupunbroch.htm

“Acupuncturists are independent health care providers; you do not need a physician referral to receive treatment from an acupuncturist. By law, your acupuncturist must advise you of the importance of your seeing a physician. When this is done, you will be asked to sign a form saying that you were advised of this. You will get one copy of this form, and a second copy will become part of your record.”

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely.
Shujing Dai, L.Ac, PhD
Jing Acupuncture Service PLLC

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RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

On behalf of the American Society of Acupuncturists and our 4500 members nationwide, we applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As representatives of the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, we seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹ The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE).³ We propose alternate language for this section in to that simply reads:

• Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service. Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile.⁴ In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely,
Dr. Ahnee Min-Yau

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Dear Sir/Madam,

I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As many Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

• Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely,

Weihong Jia

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Dear Sir/Madam,

I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As many Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

• Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely,

JunYi Zhao

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Dear Dr. Miller and Mr. Dolan:

My name is Patrick Hart 'aka Dr. Skip' and I am an O.M.D., Acupuncture Physician practicing in the state of West Virginia, whose training is from the Florida College of Integrative Medicine with Doctor's Residency completed at the Conmaul Integrative Hospital in Seoul S. Korea in 2003. My license was issued in 2003 as well. Thank you for your efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a part of the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I am asking for clarification on certain aspects of the decision memo recently issued.

Greatest relevance is highlighted below:

• Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:
• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a "Licensed Acupuncturist or state equivalent". These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of NCCAOM certification exams or state board exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

• Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired. My state of practice in West Virginia requires 1800 academic hours and 300 clinical hours with continuing education requirements annually.

Further, we ask that the term "licensed acupuncturist" be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

• Auxiliary personnel furnishing acupuncture must be under the direct supervision of a licensed acupuncturist, physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms "physician assistant" and "nurse practitioner/clinical nurse specialist". In West Virginia, we are considered primary care and do not require any supervision when licensure requirements are met.

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.
Additional Information: You may be aware of Battlefield Acupuncture (https://www.militarytimes.com/news/your-military/2018/02/09/battlefield-acupuncture-yes-it-exists-and-the-military-is-using-it-to-fight-troops-pain/) and its effectiveness as a drug-free pain management modality that is being trained and utilized in our military bases and special forces. The VA has seen this modality to be of value and is included in Veterans Choice Benefits. Blue Cross of TN has recently removed Oxycontin and added acupuncture amid the opioid crisis (reference link: https://protect2.fireeye.com/url?k=0b3e738a-576b7a5a-0b3e42b5-0cc47a6a52de-0580f86fa07433b0&u=https://dailymemphian.com/article/2059/BlueCross-removes-Oxycontin-adds-acupuncture-amid-opioid-crisis). It is our hope, we can make acupuncture a standard of care. The VA considers acupuncture effective for veterans who suffer from:

• Pain associated with an injury or illness
• Nausea and vomiting after an operation or chemotherapy
• Knee pain from osteoarthritis
• Low back pain
• Depression or other mental health concerns
• Substance dependency

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First, we are grateful to the CMS for conducting a clinic trial investigating acupuncture’s effectiveness to treat chronic low back pain in geriatric patients. We understand the need that federal health care legislators seek further evidence for the effectiveness of acupuncture in order to justify federal coverage with medicare. Despite any previous effective clinical trials involving acupuncture in the past, we understand that it needs to be on their terms and conducted within their system of research. We also would like to acknowledge and support the ASA letter and its points of argument as valid and important points of reflection for the CMS to consider. Furthermore, we would like to shed light on further topics of consideration for the CMS committee members to contemplate.

Traditional Chinese Medicine (TCM) has been an empirical based medicine for over 3,000 years in China. Acupuncture is one tool out of many for a doctor practicing TCM. The theories and etiologies of TCM are the foundation for formulating a diagnosis and treatment. Selecting specific acupuncture points, how to combine them in a treatment and how to manipulate them are based off of the theories and etiologies rooted in TCM. Acupuncture greatly depends on the quality of TCM education the practitioner received, their clinic experience treating patients and the effective results with their modalities of treatment utilized. Effective acupuncture cannot be learned solely in a weekend seminar or via adjunct CEU courses. Furthermore, one cannot obtain the same level of effective results as a qualified TCM practitioner if one is to approach TCM from any other medical frame of mind.

Regarding the specific topic of chronic low back pain in geriatric patients, it is important to first explain that there are several categories to describe and treat this condition from the point of view of TCM. Firstly, western medical etiologies describe low back pain by structure such as muscular tissue damage, bone damage, ligament damage or nerve damage. Causes of pathology may be described as due to old age, inflammation, trauma, bone degeneration, etc. or entirely idiopathic. While at the same time TCM understands these same problems and treats them, there is a different understanding as to the description of the etiologies and pathologies, why these pathologies occur and how to approach treatment. In TCM there is never an idiopathic diagnosis.

Here listed, are brief examples of different TCM etiologies and pathologies for low back pain. Typically, a two step treatment protocol is involved, treating the branch (i.e. pain symptoms) and then addressing the root cause (i.e. bone degeneration or poor blood circulation). TCM nomenclature describes a unique understanding of pathophysiological functions in the body and are how they are utilized.
Pain that presents “horizontally” across the lower back - this is due to the concept of kidney yang and kidney yin deficiency or due to the overuse of the kidney’s energy, which in turn depletes the kidney from its normal function (i.e. due to high sexual activity).

Pain that presents “vertically” following the lumbar vertebrae - this may include old injuries due to trauma from sports, an accident or previous surgical interventions. (i.e. scar tissue, bone degeneration, bulging discs)
Pain that presents both vertically and horizontally is due to pathological temperature abnormalities in the body, particularly cold & damp. Local climates play a role in this type of pathology (i.e. living in northern climates).
It is the goal of the TCM practitioner to stop pain symptoms and then proceed to resolve the underlying pathology. If the techniques of acupuncture are not effective enough then it becomes impossible to stop the pain and move on to treat the root cause. A nurse practitioner, physician assistant, M.D., or physical therapist do not possess the understanding or skills of TCM in order to effectively treat a patient with acupuncture in order to resolve pathology, unless they have gone through proper education and training in the theories, etiologies and treatment protocols of TCM. This is required for any other medical practitioner to yield effective results.

As for the selection of representatives of the acupuncture industry for clinical testing, including participants in the design and implementation process, criteria can not solely fall under the qualifications set forth by the NCCAOM (National Certification Commission for Acupuncture and Oriental Medicine). This would exclude practitioners licensed in the states of California and Nevada, who exceed those qualifications of the NCCAOM standards. This is a significant exclusion due to the fact that California acupuncturists represent approx. 40% of registered practitioners in the U.S.

Regarding acupuncture research studies, a typical research participant tends to not be qualified enough to show standard results of TCM acupuncture effectiveness due to not having enough clinical experience or holding a medical degree in another field altogether. Albeit, the researchers are highly skilled in academia or a different medical field there is a tendency to have less experience in the clinical setting of TCM. As a result, the research will yield low quality results and this will not adequately represent the real effectiveness of TCM acupuncture. This is not a good benchmark or standard from which to finalize any medical or political decisions from.
To this extent, further research is required to compare the differences of the effectiveness of acupuncture in the hands of a qualified TCM practitioner vs. that of another medical practitioner such as a physical therapist, nurse or M.D. who have received “technical” training in acupuncture needling. The purpose of this research is to demonstrate the effectiveness of TCM acupuncture techniques, and to show how when utilizing these techniques, it can more effectively treat patients and helps to create cost savings to the insurance industry and medical field.

We wish for the public to benefit from acupuncture, but in the hands of qualified practitioners. Otherwise, it wastes time and money of the patient, the medical insurance companies and the federal government. Acupuncture brings with it the potential for supporting millions of people in dealing with LBP, especially in a time when non-opioid options are more needed. It will help to reduce unnecessary medical expenses by effectively treating patients with non-invasive procedures, reducing opioid dependence, reducing surgical interventions due to ineffective medical treatments, reducing recovery time and lower readmittance levels for post-operative care in hospitals. This would save insurance companies a lot of money, help share the burden of over crowded hospitals and provide low cost solutions to chronic pain management.
Thank you for your time and consideration,

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Chronic low back pain usually is caused by inflammation from lumbar disc herniation, bulging disc, stenosis, degeneration, etc. Chronic inflammation will block the energy flow and cause stagnation and affect the nerve system. Acupuncture treatment will help circulation, break down the stagnation and ease the pain from my 14 year's clinical experience.

One of my client (age 80)has severe lumbar stenosis when she came to see me 3 years ago. She kept Acupuncture treatment every two weeks and gradually reduced her steroid shots from four times a year to once a year. She's very happy that she can delay her back surgery for many years.

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

August 08, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

On behalf of the Council of Acupuncture and Oriental Medicine Associations- CAOMA and American Alliance of Acupuncture-AAOA, and our members organizations in statewide and nationwide, we appreciate highly the outcome of the report by CMS to study the effectiveness of acupuncture for chronic low back pain (cLBP), which is in the process being evaluated and covered by Medicare. CAOMA was established in the late 1980's, CAOMA has been advocating for excellence in the education and practice of Oriental medicine and Acupuncture as a primary health care profession. In the past over 30 years of advocacy, CAOMA has developed, maintained, and promoted standards of education, clinical practice, ethics in the practice of Acupuncture and Oriental medicine in the country, and work closely with other relevant stakeholders to protect the public safety and consumer interest as a professional health care organization.

In the affected by the decisions made based on the outcomes of the planned studies, CAOMA and AAOA are in line with ASA, AACMA, CalATMA.... and all other stakeholders, seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

We are in the same position and concern as ASA-America Society of Acupuncture indicated in their letter:

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.1 The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately more than one-third of those in the United States,2 and who have passed an equivalent examination: the California 1 Summary Report for: 29-1199.01 – Acupuncturists. O*Net On-Line. https://www.onetonline.org/link/summary/29-1199.01. Accessed July 23, 2018. 2 National Certification Commission for Acupuncture and Oriental Medicine. National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) Fact Sheet: Information for California Licensed Acupuncturists and Other Interested Stakeholders about the NCCAOM Acupuncture Licensing Exam (CALE). 3 We propose alternate language for this section in toto that simply reads:

• Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile4 . In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. We are encouraging to look forward CMS doing more research works on acupuncture treating more study for other pain areas besides Chronic lower back pain. and also as it stands as one of the most effective, alternative demanding, most important and cost saving options for non-pharmacological treatment.

Enclosed our letter which we are going to mail it to your Baltimore office, please find a CAOMA's publication of First Edition of " Acupuncture and Electroacupuncture Evidence-Based Treatment Guidelines", which was published on December 2004. On page 64-66 you can find detail evidence- Based content of Chronic Lower Back Pain. as well as all other pain area part of the human body. the guideline itself was utilized for the Acupuncture profession as a reference to provide for the insurance company and also then for the California worker compensation reform legislation since 2004. We are confident looking forward to participate and work together with CMS on the future research projects with the professional practitioner experts and scholars in the Acupuncture and Oriental medicine field. We truly believe, it will reach more promising improvement for the US health care system and benefit American people' health.

Sincerely,

The Board of the Council of Acupuncture and Oriental Medicine Associations

American Alliance of Acupuncture

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I am so glad that this is being studied, however, it would be important for acupuncture to be done by highly trained professionals, that is, acupuncturists.

Every day, I have older patients asking for my help with lower back pain. Many cannot afford the service because it is not covered by Medicare. My VA patients and Mass Health patients have coverage for this condition.
While it is appropriate for an MD to oversee the studies, there is no precedent for other professionals to supervise in this kind of study.

Acupuncturists in Massachusetts have at least three years of postgraduate training, which includes coursework in research and design, as well as specific, and complex interventions for lower back pain. Our approach to lower back pain is complex and effective in many cases.

I would recommend that the section that includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describe this profession.
Many many studies have already been done, I would ask you to take a look at these studies:

1) http://www.ncbi.nlm.nih.gov/pubmed?term=acupuncture%20and%20pain
http://www.ncbi.nlm.nih.gov/pubmed?term=acupuncture%20and%20back%20pain
Accessed 1/10/13.

Ambrosio EM, Bloor K, MacPherson H. Costs and Consequences of Acupuncture as a Treatment for Chronic Pain: A systematic review of economic evaluations conducted alongside randomised controlled trials. Complementary Therapies in Medicine 2012 Oct;20(5):365-374, doi 10.1016/j.ctim2012.05.002.Epub 2012 June 6

Chen XH, Geller EB, Adler MW. Electrical stimulation at traditional acupuncture sites in periphery produces brain opioid-receptor-mediated antinociception in rats. J Pharmacol Exp Ther 1996;277:654–660. [PubMed: 8627542]

Cheng K. Neuroanatomical basis of acupuncture treatment for some common illnesses. Acupuncture in Medicine 2009 Jun;27(2):61-4. doi: 10.1136/aim.2009.000455

Furlan AD, Yazdi F, Tsertsvadze A, Gross A, Van Tulder M, Santaguida L, Gagnier J, Ammendolia C, Dryden T, Doucette S, Skidmore B, Daniel R, Ostermann T, Tsouros S. A Systematic Review and Meta-Analysis of Efficacy, Cost-Effectiveness, and Safe of Selected Complementary and Alternative Medicine for Neck and Low Back Pain. Evidence-Based Complementary and Alternative Medicine 2012; Article ID 953139, 61 pages. doi:10.1155/2012/953139

Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese Acupuncture and Placebo (Sham) Acupuncture Are Differentiated by Their Effects on µ-Opioid Receptors (MORs). Neuroimaging 2009 September ; 47(3): 1077–1085. doi:10.1016/j.neuroimage.2009.05.083

Herman PM. Evaluating the Economics of Complementary and Alternative Medicine. 2012. Samueli Institute Publishers. Alexandria Virginia.

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Thank you for considering acupuncture as a medically proven treatment for low back pain. I have witnessed positive results many times over a 10 year period treating low back pain and many other painful conditions with acupuncture.

In defining "auxilliary personnel" I would respectfully request that this be modified to specifically name "Licensed Acupuncturists or state equivalent" as we have been tested nationally and licensed in our states to perform acupuncture with appropriate education.

I would also respectfully request that supervision during the study period be done only by MD or DO degreed medical professionals. Supervision by the other licensure types does not add to the safety or quality of the trials.

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I appreciate CMS's consideration of Acupuncture's efficacy for Chronic Low Back Pain (00452N)

Please also consider the following points:

1. Please allow all auxiliary providers to be only Licensed Acupuncturists or the state's equivalent. Please note that in California Acupuncturists are required to have a MS degree or equivalent of a PhD that includes supervised clinic hours before they can even sit for the State Licensure boards. Also note that, in California, only licensed Acupuncturists and trained MDs are allowed to practice acupuncture.
2. Please also consider that supervisors required in the study portion be only MDs since supervision by other licensure types won't add to safety or quality of trials and there is no precedent for such an act.

Thank you.
Sara Weinberg, MS., L.Ac

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I am writing to encourage CMS to cover acupuncture for chronic low back pain, as well as other chronic pain conditions for all Medicare beneficiaries, not just those enrolled within an approved study.

I appreciate your decision to hear from the chronic pain community because, for some, acupuncture may be an effective alternative. Researching the history of acupuncture long ago I read about surgery being performed in China with only acupuncture and no anesthesia. This ancient method deserves your serious consideration.

The American Academy of Medical Acupuncture, the American College of Physicians, and other medical organizations have endorsed acupuncture as a front line treatment for pain in general, but more specifically, for chronic low back pain. I hope you will add acupuncture to your list of covered treatments.

In appreciation-

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Thank you CMS for your consideration of this topic. This represents a massive step towards the incorporation of acupuncture into national health care.

Please modify the section that includes “auxiliary providers” to be changed to more clearly name “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describe this licensure group. Please require supervision during the study portion be done only by an MD. Supervision by other licensure types does not have a precedent, nor does it add in any way to the safety or quality of the trials.

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Thank you CMS for your consideration of this topic. This represents a massive step towards the incorporation of acupuncture into national health care.

Please includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describe this licensure group. In California, where I practice, we are required to complete 2,050 curriculum hours and 950 hours of clinical hours. After graduating from our respective Chinese medicine schools, we then of course have to pass the grueling CA state board exam, which is currently the hardest acupuncture licensing exam in the nation. Once we pass our exam, we then have to maintain a minimum of 52 hours of continuing education hours every 2 years to maintain our licensure active.

I also ask that the supervision required during the study portion be done only by an MD. Supervision by other licensure types does not have a precedent, nor does it add in any way to the safety or quality of the trials. In California, we actually do not require any supervision by an MD as we are also regarded as primary care providers.

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Luriko Ozeki, LA.c.

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TO WHO IT MAY CONCERN:

All researcher and delegate who are conducting studies of acupuncture, must have a medical background in Chinese medicine rather than Western medicine to understand how it works. Otherwise, the results of the study are unknown, which will undermine the development of acupuncture. If the policy maker is not professional nor supports TCM (Traditional Chinese Medicine), or recognizes the importance of values, or the inability to understand TCM before conducting research, the results may be unfair and biased, leading to knowledge becoming blind. Acupuncture is a specialized medicine and research should be carried out by professional acupuncturists. Western doctors have not received enough Chinese medical training like acupuncturists.

There are 396 acupuncture points in the orthodox acupuncture points of the human body. In order to find answers, do researchers need to find every acupuncture point in each patient to understand the effectiveness of acupuncture points on low back pain? If an acupuncture point has no effect, is it effective to use two acupuncture points at the same time? Or add more acupuncture points to gain effectiveness?

In order to get knowledge of efficient acupuncture points, we should understand how the Chinese people began to treat patients with acupuncture. For example, Chinese people often use UB 54 point to treat low back pain, then we should choose UB 54 point to see how many people find relief and how many people are not effected with that acupuncture point UB 54,

then we can study why certain types of patients who do not receive effective treatment, or why this acupuncture point will help some people, such as age, gender, special treatment time zone, acupuncture techniques, physical condition etc., to get better results, instead of trying many tests but without a validation guide.

Why do acupuncturists know acupuncture more than Western doctors? Because their education is all encompassing acupuncture. The technique of acupuncture is authentic, and it is based on the science of Chinese medicine, rather than the science of Western medicine. We must accept that knowledge makes the difference in the World. It is like if we only understand English but don’t understand Spanish, does not mean that Spanish is a problematic language, not good or bad, it is just different.

Especially when Western medicine does not understand acupuncture and asks acupuncturists to treat patients with their Western medical way, they often cause conflicts of opinion. As a result, the patient may be transferred back to Western medicine for medical treatment and surgery, changing back to Western medical treatment without the patient’s agreement.

Sincerely

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As a Member of the New Jersey Association of Acupuncture and Oriental Medicine (NJAAOM) and the American Society of Acupuncturists (ASA), I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As my colleagues in the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

In the state of New Jersey, Licensed Acupuncturists have direct access and do not require a physician referral. The New Jersey Acupuncture Practice Act can be found here: https://www.njconsumeraffairs.gov/Statutes/acupuncturelaw.pdf
Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely.

Jeanny Chan, MS., LAC)®

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Thank you for considering Acupuncture for Medicare patients. I'm an ex-engineer that has been doing acupuncture for 20-years and it has been of great benefit to so many people with pain, including the elderly. If you are looking for 'non-pharmaceutical solutions to pain' acupuncture is the best choice.

I was surprised to see that L.AC.'s are not the first choice. I suggest the standard“auxiliary providers” be changed to more clearly named “Licensed Acupuncturists or state equivalent.” We have the most comprehensive training, rigorous national board certification and the best experience with acupuncture as that is what we do all day.

For me, a chiropractor, naturopath or medical doctor will not compete with my efficacy until they treat 50-100 clients a week for 10-years plus. That is what it takes to be great and in my experience only L.Ac's get that kind of experience.

There is no supervision required in our specialty for L.AC.'s in my state of Arizona and none that I no of in other states or around the world. It seems superfluous or redundant to have a supervisor that understands less about what you do than you do.

I would be more than happy to demonstrate my skills for you in regards to effective lower back treatments for the elderly.
Thank you!

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Dear Dr. Miller, Mr. Dolan

As a licensed acupuncturist (AZ) for 28 years, it is such welcome news that CMS is proposing to study acupuncture for chronic low pain.

I have carefully read your proposed document, and would like to focus on two items in particular, and respectfully ask for you to please change some wording in the two areas of focus: there needs to be clarification of importance in some text regarding "auxiliary personnel" who may furnish acupuncture if they meet "all applicable state requirements". The only health care professionals who meet the standards for state acupuncture licensing, as well as for national certification, are indeed Licensed Acupuncturists. L.Ac's are not "auxiliary personnel". Other health care professions do not meet any of the listed state educational and licensing requirements that the experts/L.Ac's must meet. Your memo as written, obscures the licensing and title of the already existing designated licensure group, and gives allowance to providers that wouldn't otherwise qualify for inclusion unless they were already licensed acupuncturists. *I propose using alternate language that says: Licensed Acupuncturist or state equivalent who has an active and unrestricted license in the state may provide acupuncture. This will eliminate confusion and conflict with state laws, as well as being more inclusive of the fully qualified licensure group. And the term Lic. Acupuncturist be included where appropriate, for clarity and proper reporting.

Understandably, supervision by a physician is important for trial purposes, but there is no precedent for licensed acupuncturists to be supervised by PA's, or NP's or clinical NS, or any other group, nor does it improve excellence in the study design, safety, or any other aspect. L.Ac's are in most states independent providers, and in some states it is only L.Ac's that can provide acupuncture. And in few cases where they may be under supervision, it is only by MD's, not PA's or nurse specialists, or others..

Thank you for your time and I sincerely hope that the comments of concern that you have been receiving from the Acupuncture profession will seriously be considered and acted on with regard to our requests.

Sincerely Della Estrada L.Ac.

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I support Medicare/Medicaid Coverage of acupuncture treatments for people who suffer from chronic low back pain.

I practice acupuncture in a low cost/high volume Community Acupuncture clinic and I have been licensed for 12 years. Low back pain is the most common reason why patients seek acupuncture. Acupuncture is better when used a first line of defense, rather than a last resort. Acupuncture is minimally invasive and side effects are rare.

Acupuncture can be used on its own or in conjunction with other kinds of pain treatments or medications, such as cortisone injections. I have worked with many patients who have been able to reduce their medication when they have regular access to acupuncture. Some have gotten off of opioid medications entirely.

If Medicare/Medicaid should cover acupuncture for those with chronic low back pain, your agency should work with all licensed acupuncturists. If they have a valid state license, then they are qualified. Please do not limit this only to acupuncture practitioners who maintain national certification with the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM). Every licensed practitioner takes the NCCAOM board exam or the very similar California exam. There is no difference in the quality of care that comes from acupuncturists who pay to keep their national certification and those who do not.

The Centers for Medicare and Medicaid Services should also consider creating billable codes to cover ear acupuncture for the treatment of Substance Use Disorder, Trauma, and all issues related to behavioral health. SAMSHA recognizes ear acupuncture as a treatment for SUD in TIP 45 and half of the states in the US allow for non-acupuncturist health providers and lay practitioners to practice ear acupuncture if they are certified by the National Acupuncture Detoxification Association or equivalent training.

Thank you for taking my input.

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[PHI Redacted] I want to thank the CMS for your consideration of this important topic if adding acupuncture to Medicare so more Americans can receive it's benefits.

However, in reading how the CMS proposes to investigate acupuncture here are a few recommendations:

1. The section that includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describe this licensure group.
2. I also ask that the supervision required during the study portion be done only by an MD as others do not have the proper training and it is unnecessary.

Thank you for you time,

Regards,
Jane Anichini

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August 11, 2019

David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
RE: Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Mr. Dolan and Dr. Miller:

I am a licensed acupuncturist in California and nationally certified by the NCCAOM diplomate in Oriental Medicine. I practice in San Francisco. I am also a member of CalATMA. Thank you for requesting comments regarding efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare.

While many licensed California acupuncturists are additionally certified by the NCCAOM, current state law does not require this for licensure or practice. The California Acupuncture Licensing Exam (CALE) has been certified to be equivalent to the NCCAOM certification exams by the NCCAOM itself. Our state’s licensure requirement of 3,000 hours of didactic and clinical training exceeds the minimum NCCAOM certification requirements as adopted by most other states. Although California has more licensed acupuncturists than any other state, more required training than most other states, and certified exam equivalency, the current framing excludes over 10,000 qualified active California licensed acupuncturists while creating ambiguity with use of the term “auxiliary personnel” in its proposed decision memo.

Only five designated licensures are permitted to practice acupuncture in California: licensed acupuncturists, physicians and surgeons (without additional certification), and dentists and podiatrists who have also completed a certification course in acupuncture. All other licensures are prohibited from practicing acupuncture unless they also hold an acupuncture license. This prohibition includes Physical Therapists, Physician Assistants, nurse practitioners, and clinical nurse specialists. State law also specifically prohibits supervision of acupuncturists by physicians, dentists, or podiatrists for training or tutorial purposes unless they are also a licensed acupuncturist. Thus, the use of “auxiliary providers” seems to attempt to allow participation by providers who would not otherwise qualify for inclusion unless they were already licensed acupuncturists, while excluding over 10,000 qualified licensed acupuncturists in California and more than a quarter of all licensed acupuncturists in the USA.

I propose the following replacement text:

Licensed acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

Instead of the current proposed text:

• Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:
  • A masters or doctoral level degree in acupuncture or Oriental Medicine
  • from a school accredited by the Accreditation Commission on
  • Acupuncture and Oriental Medicine (ACAOM);
  • a current certification by the National Certification Commission for
  • Acupuncture and Oriental Medicine (NCCAOM); and
  • maintained licensure in a U.S. state or territory to practice acupuncture.

Acupuncturists have more training in this specialty than any other designation, and we have obtained the unique Bureau of Labor Statistics (BLS) designation 29 1199.01 Acupuncturist. I request that the term “licensed acupuncturists” be used and included, where appropriate, in all data collected and reported from these studies and in all documentation related to recruiting, study methods, and other coverage based on the outcomes of the studies requested by CMS. Those decisions should be based on the actual provision of care which would include not only the number of treatments and the techniques prescribed, but also the training, licensure and proper designation of the providers of this service.

It is inconsistent with California state law that licensed acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. As mentioned previously, certain aspects of California law prohibit supervision of acupuncturists by professionals who are not themselves licensed acupuncturists. There is no precedent for the inclusion of these professionals as supervisors of acupuncturists, nor does it improve patient safety, study design or provision, or any other aspect of the validation, assessment, or decision-making process of this effort. Licensed acupuncturists have an outstanding safety profile documented in all states regulating licensure. We ask that the terms “physician assistant” and “nurse practitioner/clinical nurse specialist” be removed in order to revise this portion for consistency with state laws.

Thank you for your consideration of our comments and for providing this opportunity.

Sincerely,
Joyce Wu, L.Ac. 14078

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Dear Dr. Susan Miller and Mr. David Dolan,

My name is Lucinda Toy; I have been a Licensed Acupuncturist in California since 2009. Thank you for the opportunity to comment to and for your consideration of my thoughts to the Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N).

I am pleased to learn that CMS is embarking on a proposal to study acupuncture for chronic low back pain. Acupuncture stands as one of the most promising options for non-pharmacological treatment to pain. As you are probably aware, the national Bureau of Labor Statistics (BLS) officially designated the medical occupation of Acupuncturist with its own Standard Occupational Code which it published in the BLS handbook in 2018.

I bring to your attention a request for clarification and revision to the existing text in the Proposed Decision Memo. The passage currently reads:

One may infer the explicit requirement criteria pertains to licensed acupuncturists. The omission of specifically naming “licensed acupuncturist” while identifying the specific titles of physician assistant, nurse practitioner or clinical nurse specialist as personnel who are qualified to conduct the study’s protocol is an error. While it is not inconceivable that a physician assistant, nurse practitioner or clinical nurse specialist may also meet the eligibility criteria, the only profession fully dedicated to acupuncture in America is that of a nationally certified or state licensed acupuncturist.

It is understandable that under the auspices of safety, regulation and adherence to protocol, the trial design must include the need for a qualified physician in a direct supervisory capacity of the provider performing acupuncture for the duration of the study.

It is antithetical to place in a direct supervisory role a physician assistant, nurse practitioner or clinical nurse specialist over, and who may or may not have equal training to, a licensed acupuncturist. A state licensed acupuncturist has obtained specialized training and requirements to be eligible to participate and perform the technique in this study. What qualifications are assumed that the nurse practitioner or physician has to supervise a licensed acupuncture in the administration of acupuncture technique and treatment? The supervision of a licensed acupuncturist by a non-physician is illogical unless the attending supervisor is also equally trained and certified as a licensed acupuncturist.

The following must also be considered: “real-world” clinical practice of acupuncture (i.e. outside the controlled environment of this study) without the direct supervision of a physician is within the scope of practice for a Licensed Acupuncturist, according to state regulation.

Therefore, with all due respect to the nationally recognized definition which is both inclusive and specific in nature, which names “Acupuncturist” as a professional medical provider, and to all specifically relevant providers who are trained, licensed and meet the eligibility requirements to participate in the protocol study described in the Proposed Decision Memo, I propose a consideration to alternate language of the above-excerpted section of the document to simply read:

While it may appear to be a matter of semantics, the suggested replacement text is not inconsequential to the impact of the imminently established precedence:

• The proposed study to include acupuncture for the management of low back pain suggests a significant expansion of potential support through benefits of coverage to patients who may seek effective acupuncture treatments for pain through the services of state recognized Licensed Acupuncturists;
• State Licensed Acupuncturists will likely be the providers of the majority of acupuncture services to patients beyond the duration of the proposed study.

I urge the committee to consider the choice of appropriate language and protocol of the study and I applaud CMS’ aim of the trial to assess improved outcomes of pain through acupuncture treatment.

Respectfully submitted,

Lucinda Toy
California State AC #13389
NCCAOM #112382

PS. One correction is unquestionably warranted in Section II. Background:

The correct acronym is NCCAOM.

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Hello, we have received over 50 calls in the last two years from people with Medicare interested in acupuncture for back, shoulder, and neck pain. These people are interested in trying acupuncture because nothing else has worked for them. Many of whom received positive feedback from others who found relief from acupuncture through our clinic or another practitioner.

Our clinic is interested in participating in this study. We are an hour away from Sacramento, CA, in El Dorado County, where 21% of the population is over 65 (census.gov). We have experience billing insurance with multiple companies, including BC/BS, Cigna, UnitedHealthcare, and Veteran Affairs. We serve Veterans in the area who are unable to make it to the V.A. due to distance and or their inability to see them within 60 days.

Caleb Masuda, L.Ac., Dipl. O.M. is an acupuncturist and herbalist licensed in California and nationwide. His treatments provide relief to over 80% of the pain patients that visit him.

The best number to reach me is (530) 303-8245.
Thank you for your time,

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Acupuncture is working well with chronic lower back pain.

As medical doctor graduated at 1988. I was surgeon working in china hospital. Orthopedic surgeon, lower chronic back pain related to almost all the human's life. result is pain in lower back and tighten on back mobility. western treatment is using pain medication which block pain feeling go to brain. It could working well to easy the lower back pain by block them.
Acupuncture is working more direct on the pain & tighten muscles on lower back, it could lose the tightening muscles and improve blood circulation on pain( inflammation) lumbar region. it really did the treatment on where the problem cause.

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August 13, 2019

David Dolan, MBA
Lead Analyst
Centers for Medicare & Medicaid Services
Attention: CAG-00452N
P.O. Box 8013
Baltimore, MD 21244-1850

Submitted electronically via http://www.cms.gov

Dear Administrator Verma,

On behalf of over 34,000 orthopaedic surgeons and residents represented by the American Association of Orthopaedic Surgeons (AAOS), we appreciate the opportunity to provide comments on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N), published on July 15, 2019. According to the CDC’s National Health Interview Survey, more than one in three adults experience low back pain and adults over age 65 have the highest prevalence.¹

We commend CMS on its efforts to explore alternative therapies for chronic low back pain (CLBP) while working to reduce the impact of the opioid epidemic. This proposed decision memo touches on several issues which directly impact our membership, and we hope that you will consider our comments when making any final changes in policy.

AAOS is pleased by the consideration of acupuncture as a complementary, non-clinical remedy for CLBP. Particularly among the population served by Medicare, the use of holistic treatments that increase hope and bolster socialization through the patient-clinician relationship are growing evermore central to a patient-centered approach to care. Complementary and alternative medicine (CAM) may be a valuable supplement to traditional orthopaedic practice, and appropriate for use as an alternative to pain medication in a select group of patients.

Although the prospect of including acupuncture as a Medicare-covered treatment for CLBP is appealing, it is essential that the research methods employed to determine its effectiveness be rigorous. Some primary concerns include the uniformity of the study protocol (defined diagnoses, number of treatment episodes), study monitoring methods (re-approval process, timeframe), and the adherence to the scientific method as it relates to the duplication of studies.

Simply acknowledging statistical significance and single study efficacy in the absence of defined minimum standards for study power and peer-review would not instill confidence in practitioners for a future prescription of acupuncture.

Specifically, the issue of publication bias has been raised as having significant implications for the research of new treatment options. According to Cochrane, publication bias can be defined as the publishing or non-publishing of research results based on the nature or direction of the results.² In a study published earlier this year in The Journal of Bone and Joint Surgery, researchers analyzed 694 systematic reviews and meta-analyses to determine the proportion of studies that addressed or assessed the impact of publication bias. The results of this study found that just 42.5 percent of studies discussed publication bias and only 19.5 percent assessed publication bias.³ When determining the efficacy of acupuncture for CLBP, we trust that CMS will use research that has been thoroughly assessed for such bias.

AAOS also encourages CMS to make clear a definition of “expertise” when determining which practitioners may be reimbursed for acupuncture treatment. Given the broad scope of personnel described in the proposed decision, it would be prudent to set a minimum standard for education and experience in acupuncture for practitioners covered by Medicare.

Thank you for your time and consideration of the American Association of Orthopaedic Surgeons’ suggestions. We greatly appreciate the opportunity to share our thoughts on the use of acupuncture in the treatment of CLBP. AAOS respects CMS’ commitment to advancing research and expanding treatment options for patients. If you have any questions on our comments, please do not hesitate to contact William Shaffer, MD, AAOS Medical Director, by email at shaffer@aaos.org.

Sincerely,

/s/
Kristy L. Weber, MD, FAAOS
President, AAOS

cc: Seema Verma, MPH
Susan Miller, MD
Joseph A. Bosco, III, MD, FAAOS, First Vice-President, AAOS
Daniel K. Guy, MD, FAAOS, Second Vice-President, AAOS
Thomas E. Arend, Jr., Esq., CAE, CEO, AAOS
William O. Shaffer, MD, Medical Director, AAOS

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I support the points made in the following letter by the American Society of Acupuncturists:

David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

July 24, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

On behalf of the American Society of Acupuncturists and our 4500 members nationwide, we applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As representatives of the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, we seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and AUXILIARY PERSONEL may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California

Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

August 12, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

As an acupuncturist and registered nurse, I would like to applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a Licensed Acupuncturist (L.Ac.), I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

• Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and "auxiliary personnel" may furnish acupuncture if they meet all applicable state requirements and have:
• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• A current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• Maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹ The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination:

The California Acupuncture Licensing Exam (CALE). ³ I propose alternate language for this section 'in toto' that simply reads:

• Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, I ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While I understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. ⁴ In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. I ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. I am delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment. I personally think it is the best option for pain management based on personal and professional experiences.

Warm Regards,

Rosemary A Hersey, BSN, RN, M.Ac, L.Ac
AcuRosieRN@gmail.com
603-965-6949

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I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a representative of the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, we seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

July 24, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan, I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As representatives of the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, we seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

[PHI Redacted] I want to thank the CMS for your consideration of this important topic if adding acupuncture to Medicare so more Americans can receive it's benefits.

However, in reading how the CMS proposes to investigate acupuncture here are a few recommendations:

1. The section that includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describe this licensure group.
2. I also ask that the supervision required during the study portion be done only by an MD as others do not have the proper training and it is unnecessary.

Thank you for you time,

Regards,
(Mary Grace Bertulfo

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services 7500 Security Boulevard
Baltimore, MD 21244
August 13, 2019

Dear Dr. Miller and Mr. Dolan:

On behalf of the American Society of Acupuncturists and our 4500 members nationwide, we applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As representatives of the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, we seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹ The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE).³ We propose alternate language for this section in toto that simply reads:

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service. Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile.⁴ In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely,

The Board of the American Society of Acupuncturists

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Dear Sir/Madam,

I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As many Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

To Whom it May Concern,

Thank you for the opportunity to comment on the topic of acupuncture for low back pain.

I am a licensed acupuncturist in the state of Minnesota.

I work at the Penny George Institute for Health and Healing (Part of Allina Health). We are the largest integrative medicine clinic embedded within a large Health Care Organization in the USA.

I collaborate with MD's, Spine Surgeons, Chiropractors and physical therapists.

I have been in practice for 10 years and have seen first hand the incredible benefit that acupuncture has provided patients dealing with chronic low back pain.

Acupuncture has been shown in high quality meta-analysis to be a safe and effective drug-free option for the treatment of chronic low back pain.

Acupuncture has been shown to be cost-effective and reduce total health care expenditures.

The American College of Physicians currently have within their top recommendations, for either acute or chronic low back pain, non-pharmacological interventions, including acupuncture.

The Joint Commission recommends acupuncture as non-pharmacologic treatment for pain management.

Acupuncture has been shown to be more effective than IV morphine for pain in the ED.

Acupuncture has stood the test of time.

While I am grateful that CMS is creating this opportunity, I must must respectfully ask, "why?"

Why, when we have mounds of high quality research are we spending more time, energy and dollars to do additional research when we know beyond a reasonable doubt that acupuncture outperforms placebo acupuncture?

Why are we delaying coverage for acupuncture when provided by a trained licensed acupuncturist for patients in need?

Why with in the midst of an opioid epidemic are we continuing to deny patient's a safe and effective treatment to help ease suffering?

I would also ask CMS to update Medicare statute by replacing “auxiliary personnel” with “licensed acupuncturists or state equivalent.” The qualifications for auxiliary providers exactly describe this licensure group – a masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM); a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and maintained licensure in a U.S. state or territory to practice acupuncture. In 2017, the U.S. Bureau of Labor Statistics (BLS) established an independent standard occupational code (SOC-29-1291) for acupuncturists.

Thank you so very much for allowing me to express my thought regarding this.

Sincere Regards,
Michael Egan, L.Ac. Dipl. OM., M.O.M.

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Dear Dr. Miller and Mr. Dolan (U.S.Centers for Medicare and Medicaid Services):

As a practicing licensed acupuncturist in the state of Hawaii, I thank you for CMS efforts to study the effects of acupuncture on low back pain on those covered by Medicare.

I would like to point out, just for clarification purposes, that most if not all states in the U.S. require state and/or national certification exams for persons practicing acupuncture without supervision by PAs, NPs, or CNSs. In fact, in order to hold a licensure as an acupuncturists, we are required to undergo 3-4 yrs Master's degree education, making it unlikely that PA/NP/CNS would be able to provide acupuncture in any state unless they hold dual license.

The decision memo issue recently states: "PSs, NPs, CNSs and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements..." is unclear regarding who can provide acupuncture, since the only population able to provide acupuncture treatments and services in the U.S. are license acupuncturists.

I propose to please consider alternate language for this section that reads: "Licensed Acupuncturists or state equivalents who carry active license in that state may provide acupuncture." Thank you very much for your time and consideration. I am grateful and look forward as an acupuncture provider to offer pain management alternative beyond pain medication to Medicaid and Medicare patients. I am frequently asked by those patients whether our services are included in their plan, and I am hoping and hopeful to soon say yes.

Sincerely,
Lucia Chung LAc

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With reference to CMS National Coverage Analysis (NCA) Tracking Sheet for Acupuncture for Chronic Low Back Pain (CAG-00452N).

We would like to propose a beneficial change in which the coverage and inclusion criteria would encompass preceding noninvasive devices, that have obtained an FDA 510k related to the treatment of chronic low back.

Particularly in which, Erchonia Corp received an FDA 510k for the treatment of Chronic low back pain (K180197) in Feb 2018. The FDA clearance was granted based on a multi-site, double-blind clinical study; subjects with an average duration of low back pain of apx. 8 years achieved a 58% reduction in pain within just 3 months. The treatment also demonstrated even greater long term success as subjects that participated in the 12-month post evaluation reported an additional 17% improvement in pain. Also, notable improvement in the Oswestry Disability index (ODI) of 34% from baseline to 12-month post evaluation. Procedure was performed with a low-level laser that is completely non-invasive and with no known side effects.

We deeply appreciate the efforts of CMS looking for new health care alternates for chronic low back pain. The Erchonia FX635 laser has been proven safe and effective through FDA, for the treatment of chronic low back pain. This aligns with the goals of CMS, seeking safer and more effective options in replacement of medications and surgery.

If you would the FDA 510K letter and study results I’d be glad to send over.

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Thanks to CMS for considering and studying Acupuncture as a potential covered benefit for low back pain. I am excited about the potential for public benefit this inquiry may produce, especially in light of the opioid crisis and the need for access to non pharmacologic choices in pain management.

I am an Acupuncture Physician/Practitioner of Oriental Medicine, licensed in Pennsylvania and Florida for 27 years. Upon reading the parameters of the study it was glaringly evident to me that professional, licensed, acupuncturists like myself were omitted from mention or participation in this study and presumably from consideration as potential providers should acupuncture be accepted as an allowable treatment by CMS. I would appreciate clarification and reassurance that licensed providers of Acupuncture would be given an opportunity to participate freely as providers to serve the public with their expertise.

I am concerned for the safety of the public, the integrity of the study, and subsequent public access to acupuncture by the existing CMS provider network. Due to the inherent inconsistencies in many state laws, some CMS providers practice acupuncture with no training or verified demonstrable skills, as acupuncture is bundled within the scope of many medical licenses. How is the public served and safety assured if the responsible providers lack expertise? Yet, supporting and auxiliary personnel including nurse practitioners, physician assistants, etc., must be credentialed to the highest current standards of acupuncture. These current standards do not exceed the existing standards of a qualified trained acupuncturist, and I feel it is inappropriate to place auxiliary and supporting staff in a superior, supervisory, position in the provider hierarchy over licensed acupuncturists, many of whom have the status of primary care provider in their states. Florida is one such state and I happen to possess an active license there and would be impacted adversely if I could not serve my geriatric clientele in a fair, competitive, professional, playing field.

I am grateful to be a part of this discussion and feel we are in a pivotal, historical, moment in the history of healthcare and trust that the administrative legal process will function with high-minded precision.

Sincerely,
Ross H. Kaplan, ND,L.OM

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

August 14, 2019

Re: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan,

The Minnesota Acupuncture Association (MAA), on behalf of our members, the patients they care for and colleagues across the state of MN, applaud the effort of the CMS to further study the effects of acupuncture for chronic low back pain. The CMS has a unique position to make a meaningful impact in healthcare for the ongoing care of Americans with chronic low back pain as well as saving cost to taxpayers via offering coverage of minimally invasive non-pharmacological interventions such as acupuncture.

Our Organization
The Minnesota Acupuncture Association (MAA) is Minnesota’s statewide professional association for licensed practitioners of acupuncture. The MAA represents over 500 licensed acupuncturists across the state with a growing member base for the past decade.

Minnesota stands as a unique leader in the field of medicine. In fact, due to the growing demand acupuncture healthcare services, the state is currently home to two universities offering acupuncture programs. Furthermore, Minnesota continues to lead the way within the acupuncture profession by being one of the only states in the midwest to offer full Doctorate of Acupuncture degrees, the highest level of training available.

Language Clarification
The MAA urges CMS for clarification of some of the language within the proposed decisions. The relevant text is highlighted in the following bullet points:

Physicians assistants, nurse practitioners/clinical specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• a masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language presents certain issues and is inconsistent with existing laws and licensure in much of the country. Whereas Physicians Assistants, Nurse practitioners and other practitioners may meet the above stated requirements. Those individuals, if indeed there are such practitioners, would in fact hold dual licensure and be recognized as a Licensed Acupuncturist or the current state equivalent. The MAA strongly urges the CMS to adopt language that recognizes that a Licensed Acupuncturist or state equivalent be included within the current study. The Bureau of Labor Statistics (BLS), since 2017 has recognized and established a unique Standard Occupational Code (SOC-29-1291) for acupuncturists (6)(7). This establishes acupuncturists as a unique and therefor preferred provider for this procedure.

In addition, while the MAA recognizes the need for physician oversight during the initial trial period of this proposed study, CMS must also realize that this is outside of accepted current standards of practice and inconsistent with state licensure across the country. There is no evidence that such oversight serves to improve efficacy or safety of the procedure. We ask that this language be amended to remove such terms from the proposed study moving forward and that new language adopted specifically include terms regarding Licensed Acupuncturists or state equivalent.

Acupuncture for Chronic Low Back Pain
Rates of incidence of chronic back and neck pain are estimated to affect over 54 percent of Americans during their lifetime (1). Additionally, studies show that those individuals with chronic low back pain have increased rates of utilizing government health plans and have increased medical visits (2) with further increases in the fifth and sixth decades of life. Low back pain, both chronic and acute, have long been studied in conjunction with interventions of acupuncture. There is strong evidence to support that acupuncture has positive and sustainable effects on reducing pain, improving quality of life for sufferers, as well as lowering other types of healthcare costs such as medications and invasive procedures.

The MAA believes there is substantial evidential proof to support Medicare coverage of acupuncture for chronic low back pain. We submit the following with research to outline these key points in support of acupuncture for chronic low back pain:

• Acupuncture is effective for chronic low back pain
• Acupuncture is safe when performed by licensed practitioners
• Acupuncture can be performed at lower cost than conventional means

The American College of Physicians currently have within their top recommendations, for either acute or chronic low back pain, non-pharmacological interventions, including acupuncture (3).

Acupuncture is recognized as one of the most affordable therapies available in the current medical resource pool and considered a low risk treatment option with little to no side effects when performed by trained and licensed acupuncturists, as presented in a published review of 229,230 patients by Witt, et al, in Forsch Komplementmed Apr 2009 (4).

In May of 2012 Miller, et al., reported their findings, subsequently published in the BMC Complementary and Alternative Medicine June 2012, at the International Research Congress on Integrative Medicine and Health that post-operative joint replacement patients who received acupuncture demonstrated substantially less self-reported pain. Further published findings by Vickers, et al, in JAMA 2012 and Corbett, et al, in Osteoarthritis and Cartilage Sep 2013 (5) reporting that acupuncture is shown to be an effective treatment for acute and chronic back pain, neck pain, migraine headache and osteoarthritis of the knee.

Conclusion
The MAA would like to thank the CMS for its consideration of acupuncture for the treatment of chronic low back pain and offers its highest recommendation for the inclusion of acupuncture as an effective intervention. The MAA understands the need for studies such as these when adopting new interventions into CMS services. However there is clear evidence shown via research in recent years to clearly indicate the use of interventions such as acupuncture and should be adopted outside of the need for further studies. Including acupuncture as a Medicare benefit for the treatment of low back pain, will ultimately allow for enhanced coverage by evidence-based, non-pharmacologic pain interventions in compliance with modern and up-to-date recommendations.

Sincerely,
The Minnesota Acupuncture Association Board of Directors

Dr. Nicholas Dougherty DAOM, L.Ac
President

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As a Licensed Acupuncturist in Massachusetts, I applaud the Centers for Medicare and Medicaid Services for moving forward in studying the effects of acupuncture on low back pain. Acupuncture has proven time and again to be an effective tool for acute and chronic pain, and I look forward to seeing the results of this study.

I want to show my support for the research being done, but also would like to add to this my support for the inclusion of Licensed Acupuncturists, rather than "auxiliary providers" which is how the proposal is currently worded. Licensed Acupuncturists are thoroughly trained and qualified for this important work and should certainly be included in this study as a qualified provider of acupuncture therapy.

I also support that Licensed Acupuncturists conducting this study be supervised by a Medical Doctor, but not under a physician's assistant, nurse practitioner/clinical nurse specialist.

Thank you for your consideration of this important request.

Jennifer Alberti, LicAc
Licensed Acupuncturist, Boston, MA

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Dear Sir/Madam,

I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As many Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

Dear Sir/Madam,

I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As many Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

Dear Sir/Madam,

I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As many Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely,
Hua Gu,Ph.D.,L.Ac.

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August 12, 2019

David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services 7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Miller and Mr. Dolan,

We in the acupuncture community are grateful and supportive of your study to determine the effects of acupuncture in the treatment of low back pain. I hope that your are selecting qualified licensed professionals to provide the treatments in your studies.

I am a clinical instructor at Atlantic Institute of Oriental Medicine (ATOM) in Ft. Lauderdale, Fl. Our program leads to a Masters of Oriental Medicine and requires 3200 hours of training for completion. ATOM also offers a 2 year post graduate program to earn a Doctor of Acupuncture and Oriental Medicine. This program requires licensure and offers specialties in internal medicine. One of the goals of this program is to facilitate research.

Acupuncture and Chinese Herbal medicine have grown to be nationally accredited and state licensed in most states. They are widely accepted by the public. Most states require national board exams through NCCAOM. Some insurance companies pay for acupuncture. Many states require that when acupuncture is covered as an insurance benefit when performed by MD’s or Chiropractors (with minimal training and no board exams) it must be covered when performed by a licensed acupuncturists.

We are thrilled that your program may open to door to acupuncture for Medicare and Medicaid participants. It will improved the health and lives of millions. It will help stem the opioid epidemic. It will prevent many unnecessary, expensive surgeries. It will allow many to live healthier and happier lives. In the long run it will lead to huge cost savings for Medicare.

Thank You,

Dickie Walls DAOM

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David Dolan
Susan Miller, MD
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Mr. Dolan and Dr. Miller:

On behalf of the Northeast Ohio Opioid Consortium, I would like to express support for the Centers for Medicare and Medicaid Services’ consideration of acupuncture as a Medicare-covered treatment option for patients with chronic low back pain.

The Northeast Ohio Hospital Opioid Consortium is a hospital system-based and physician-led collaborative of healthcare organizations working together to significantly reduce the impact of the opioid epidemic in our region. We are doing so by sharing and implementing evidence-based practices; promoting policy changes; and increasing prevention efforts. Opioid Consortium partners include The Center for Health Affairs, Cleveland Clinic, MetroHealth, St. Vincent Charity Medical Center, University Hospitals, VA Northeast Ohio Healthcare System, and the Academy of Medicine of Cleveland and Northern Ohio.

America faces two inter-related public health crises—chronic pain and opioid misuse. Chronic pain is the most prevalent, costly and disabling health condition in the U.S. According to the National Academy of Medicine:
- 100 million American adults have chronic pain, and over 60% of veterans suffer from post-deployment pain.
- Painful arthritic, musculoskeletal and back/spine disorders are the leading causes of disability in the U.S.
- Chronic pain and opioid misuse together cost the U.S. economy more than $1 trillion annually.

Acupuncture is one of the oldest and most commonly used treatments in the world. Modern science has shown that acupuncture can cause multiple biological responses in the body to reduce pain, reduce inflammation and restore balance.

Over the past 10 years, the National Institutes of Health, through its National Center for Complementary and Integrative Health (NCCIH), has committed over $1.3 billion to studying complementary therapies. Among the findings are that acupuncture can provide more effective and faster analgesia than morphine, and acupuncture is a cost-effective treatment option that can create savings for patients with a variety of health conditions, including migraine, angina pectoris, severe osteoarthritis, and carpal tunnel syndrome.

Acupuncture is currently covered for Medicaid patients in nine states (CA, CT, MA, MD, MN, NJ, OR, RI, TX) and is being piloted in two additional states. It is covered by the Veterans’ Administration and many major health plans on an employer-specific basis. Finally, Blue Cross Blue Shield of Tennessee recently expanded acupuncture coverage while increasing restrictions on opioid coverage.

The Opioid Consortium sees significant potential in the use of acupuncture to provide the treatment needed by patients suffering with chronic low back pain while at the same time protecting against the risks associated with exposing patients to potentially addictive opioid medications. We support the consideration, and ultimate inclusion, of acupuncture as a covered treatment by the Centers for Medicare and Medicaid Services.

Sincerely,
Randy Jernejcic, MD
Chair, Northeast Ohio Hospital Opioid Consortium

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I want to thank CMS for consideration of the Acupuncture for Chronic Lower Back Pain Study. This represents a big step towards the incorporation of acupuncture into national health care.

Please change the section that reads: “Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist”.

The section that includes “auxiliary providers” should be changed to: “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describes this licensure group.

Florida law chapter 457 requires Licensed acupuncturists to perform acupuncture treatment. Licensed acupuncturists are primary health care providers and do not require supervision of “a physician, physician assistant, or nurse practitioner/clinical nurse specialist”. Currently under Florida laws the “physician assistant, or nurse practitioner/clinical nurse specialist” are not allowed to practice acupuncture. Not many MDs have acupuncture training. There simply are not enough MDs with Acupuncture training available to supervise licensed acupuncturists while they perform acupuncture treatment to ensure the safety or quality of the trials? Physician assistants, or nurse practitioner/clinical nurse specialists are not qualified to supervise licensed acupuncturists while they perform acupuncture treatment to ensure the safety or quality of the trials.

Please alternate language for this section in total that simply reads:

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AUGUST 12, 2019

REMINDER: CALL TO ACTION!! DEADLINE IS AUGUST 15
WHEN YOU GET TO THE COMMENT PAGE - You have to click on CMS PHI Posting Policy and spend some time reading it, then click on the box next to "I have read and understand the CMS policy regarding redaction of PHI". Then you can put in your information and leave your comment
Include some information from here
Ask that the section that includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists or state equivalent”

Also let them know that in Florida we have 2700+ hours of training with 600 hours supervised in the clinic. We are considered primary care healthcare providers.

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Dear Sir/Madam,

I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As many Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

* As an acupuncturist who treats thousands of patients a year, many of whom are suffering from back pain, I really hope the studies include acupuncture treatment that is 'distal' to the location of the pain. I say this because simply inserting the needles into the location of the pain is significantly less effective than inserting them remotely. This is probably why much of the research findings are a bit lackluster. Unfortunately acupuncture students are not taught these more effective means in school and this is why the distal methods of practicing acupuncture (ie Tung Points, Tan's Balance Method etc) are very popular continuing education classes for graduates who are not seeing the results in their practice by means of what they're taught in school. It also explains the growth of Community Acupuncture where patients are treated in a communal space while seated in recliners & back pain is relieved multiple times every day without inserting needles in the back - all at a much more affordable price. Although community acupuncturists are too busy relieving back pain (as well as many other conditions including neck & shoulder pain, carpal tunnel pain and so on) to design/perform research studies, any sincere desire to truly determine the efficacy of acupuncture for cLBP should include distal points in lieu of acupuncture at the location of pain.

* The requirement of being NCCAOM certified to conduct research or perform acupuncture is misinformed and excessive. While I recognize the need for the NCCAOM to manages the licensure exam required by many/most states for licensure, the NCCAOM has also taken the acupuncture profession hostage by charging exorbitant fees to 'maintain credentials' and fuel their political lobbying arm all while threatening those acupuncturists - either pay their dues or be forced to pay penalties and take the exams all over again if you ever want to practice in a different state...as if magically everybody forgets how to practice acupuncture because they didn't write a $400+ check or it actually costs more than a few bucks a year to store 10 kb of data on a server). I strongly believe that it is state licensure that should set the bar for everything the memo requires NCCAOM certification now and in the future. NCCAOM does not represent most acupuncturists, we're just being held hostage by their over-reaching requirements and threats.

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The Notion that CMS, is going to require that there ONLY be supervision, by an MD for this study, regarding Acupuncture's effect on Low back pain, is just Not right.

The section that includes “auxiliary providers” should be changed to more clearly name “Licensed Acupuncturists" or maybe the "equivalent” of others that at least have the same amount of training that “Licensed Acupuncturists" are required to have. The qualifications for auxiliary providers, does Not exactly describe this licensure group.

The laws in our state of Florida, for “Licensed Acupuncturists" requires they have training, that is sufficient enough to allow them, to also be considered "Licensed Primary Health Care providers" & to also be able to call, themselves - "Acupuncture Physicians" and these “Licensed Acupuncturists" do NOT have to practice under the supervision of a physician, in their daily practices and therefore, should not have to have supervision ONLY from Other Physicians, for this Trial that is being proposed by CMS, regarding and involving Acupuncture's effect on Low back pain.

Acupuncture has been around for thousands of years, used by more than 2/3rds of the world's population, for a reason. Having supervision being required, during the study portion of this Trial, for Acupuncture's effect on Low back pain, to be done "ONLY" by MD Supervision & Not by any other licensure types, does not have a precedent, nor does it add in any way - or work, in terms of protecting the safety or quality of this trial and the general Health and welfare of the general Public.

- Please Note, that supervision, for the trial phase in general, just doesn't seem necessary, to be exclusively done by MDs as their focus would be to discredit acupuncture, being done by “Licensed Acupuncturists" as they have tried to do this before

- in the state of Florida and other places - MDs are already in deep trouble, as the general population, is becoming more educated and are beginning to distrust MDs for their indiscriminate use of drugs - that are poisonous to our bodies - and not believing that what we eat and food in general, has no effect on our health; Just look at the food being served in most hospitals! Plus, the unnecessary surgeries,MDs are so willing to give and suggest and offer to their patients, with often disastrous results, sometimes even causing death. Please note, that No one has ever died from an Acupuncture Treatment!

This requirement CMS is considering of having ONLY supervision by MDs for this study, seems to be discriminatory towards all “Licensed Acupuncturists" and is threatening the possibility, of there being healing and the reduction of pain, for so many that are currently, suffering. Please Note that this kind of supervision by an MD - is Not required, or applies ever - during the general practice, done by “Licensed Acupuncturists" - as they do NOT have to practice their skills, as “Licensed Acupuncturists" under the supervision of a physician, on a daily basis - Why would this, then be deemed necessary for this trial? - I believe that CMS, should not require that there be supervision ONLY done by an MD for this study and they should consider including, an even number of MDs to be matched and monitored by “Licensed Acupuncturists".

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Thank you CMS for taking into considering acupuncture treatment in clinical studies on low back pain. As a licensed acupuncture physician in the state of Florida, I can attest to acupuncture's effectiveness in treating acute and chronic low back pain. The majority of my patients seek relief for back pain and 95% of those patients experience varying degrees of relief just after 1 treatment. Acupuncture is a cost-effective, non-pharmaceutical, and non-invasive pain management therapy. Therefore, acupuncture treatments warrant Medicare and Medicaid coverage. I am requesting the term "auxiliary providers" be changed to "Licensed Acupuncture Physician", "Doctor of Oriental Medicine" or Board Certified Licensed Acupuncturist". In the state of Florida, in order to become a Licensed Acupuncture Physician, one must graduate from a 3 year master's level accredited school. The professional master’s level Oriental Medicine program of the institution must be accredited by the Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM), which is the recognized accrediting agency for the approval of programs preparing acupuncture and Oriental medicine practitioners. The institution requires extensive training and subject matter knowledge as follows:

Graduates receive a Bachelor of Science Degree in Professional Health Studies and a Master of Science Degree in Oriental Medicine. In addition, the individual must obtain a Clean Needle Technique certification. After graduating from the institution/college s/he must obtain licensure from the Florida Board of Acupuncture and certification by the National Certification Commission For Acupuncture and Oriental Medicine (NCCAOM). To offer the highest quality of care and safety standards, it's imperative to specify providers as "Licensed Acupuncture Physician" or "Board Certified Licensed Acupuncturist" in the proposal. Thank you very much for your consideration.

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It's great that CMS is proposing acupuncture services for cLBP and as a clinician in a busy clinic that delivers ~20K txs annually I know that many people get relief from chronic LBP when they can access acupuncture, both because of affordability (or coverage) and when they need it.

However, an important distinction needs to be clarified with regard to acupuncture licensing and certification. Most states require acupuncturists to have passed a national certification exam. A few states, California, Nevada and NM, have their own exams. Many practitioners maintain their licenses by meeting their state's CEU requirement but do not keep their national certification because it is in a sense redundant with regard to CEUs, and an added expense.

VHA recently made it a requirement for those hired to be NCCAOM certified, effectively leaving out licenses in 3 states who have no need to take the national exam, and any other licensed acupuncturists in good standing who have elected not to maintain active "certification" status with NCCAOM.

For the sake of access I hope that CMS will not make this same choice.

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Thanks CMS for considering acupuncture to be covered by national health care. Acupuncture services are already covered by many commercial insurance plans. This step could bring great benefits to the patients as well as the care plans.

As for the trial, I strongly recommend that licensed acupuncture experts must involve in all the clinical trial stages of design, course of treatment and outcome evaluation. In the field of acupuncture, only licensed acupuncturists has the best knowledge of needling strategies to obtain the best effect of acupuncture. So a team of acupuncture experts should be formed to executed the clinical trial.

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

August 12, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

I am excite to hear that the CMS is going to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a Licensed Acupuncturist (L.Ac.), I am affected by the decisions made based on the outcomes of the planned studies, and therefore, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹ The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE).³ I propose alternate language for this section in total that simply reads:

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It is wonderful that you are planning to study the effects of acupuncture for chronic low back pain in populations covered by Medicare. This is a huge step towards the incorporation of acupuncture into national health care.

As a licensed acupuncturist (L.Ac.), in Massachusetts and California, I ask that you change the section that includes “auxiliary providers.” To more clearly state something to the effect of:

In order to obtain my licenses in MA and CA, I graduated from an ACAOM accredited and California approved school. I passed both the NCCAOM exams and the California boards. I maintain my licenses and certifications by meeting and exceeding required continuing education credits. In MA and CA, I am not supervised by any other health professional, including MDs. Nor do I need a referral from an MD in order to practice acupuncture.

While I understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, by and large, independent providers nationally, and have an outstanding safety profile. I ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment.

Sincerely,
Susana Byers, L.Ac.

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To Whom It May Concern:

First of all, thank you very much for considering allowing Medicare coverage for acupuncture for low back pain. It is one of the most common issues we treat, and one of the most common issues that senior citizens call us asking if Medicare will cover.

There is considerable research showing the benefits of acupuncture for chronic low back pain and many other issues. It is something that most insurance plans- including Medicaid here in Ohio and some other states- already cover.

I have a few suggestions.

1. Please make sure that the section on auxiliary providers includes a phrase similar to "Licensed acupuncturist or state equivalent." Here in Ohio we are required to have an extensive master's level education which includes over 3000 hours of training.
2. Supervision during the study period (although an onerous requirement) is sufficiently and most optimally done by an MD not another healthcare provider. There was a period in our history here in Ohio in which MD supervision was required for the first year of acupuncture license. That rule has since been eliminated.

In short, we think this is a wonderful step in the right direction to improve the quality of healthcare for all Americans. We have given just a few suggestions to improve the process.

Thank you

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Thank you, CMS, for taking the time to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As a Licensed Acupuncturist (L.Ac.) and acupuncture educator, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• Masters or doctoral-level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion unless they were already Licensed Acupuncturists. The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as in Californiawhich represents approximately one-third of Licensed Acupuncturists in the United States.

I support the American Society of Acupuncture's proposed alternate language for this section that simply reads:

Dear CMS,
As a licensed Acupuncturist in Fl for decades and former MD in China, I thank CMS for their consideration of this topic.

Acupuncture as part of the Chinese medicine has been practiced as the holistic medicine system over the world.

Many clients have been helped regarding lower back pain in particular and overall better quality of life in my decades of practice..

I applaud this initiative and it is high time.

As for the protocol of the study, I would like to recommend that the section that includes “auxiliary providers” be changed to more clearly name “Licensed Acupuncturists or state equivalent”.

This is fitting as they are the specialists delivering the service and they should be part of the study.

Lastly, I strongly recommend that the supervision required during the study portion be done only by an MD.

Thank you much for the initiative and god speed to a successful trial.

Sincerely yours,

Guansu wang

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Thank you for your consideration in using Acupuncture for chronic low back pain.

I am currently researching injury induced apoptosis from traumatic injury along the spine. I hope to publish my results after I present my findings in October. What I have found is biochemical responses to Acupuncture that can facilitate the healing process in the spinal cord through a meta-analysis. That being stated, I have clinically helped patients and worked along with other medical providers to achieve therapeutic goals in chronic low back pain.

I would like to know if it is possible to change the term auxiliary providers to clearly state Licensed Acupuncturist. It seems the qualifications explained represent this licensure group. I have over 4,432 hours of academic education not including a 5 year internship, 1 year working at a dedicated VA clinic, and additional advanced classes. This education does not include my BS in Biology. In addition to education, I had to pass several computer based exams to prove I could serve the community. A total of 4 exams and 1 hands on observation was required before I was able to ascertain my acupuncture license.

Please consider supervision required during the study to only be done by a medical doctor. It would be wonderful to know the study is being observed by an individual or team that have superior knowledge in safety and qualifications.

Currently, in several states that I have a acupuncture license, only acupuncturist can perform acupuncture. Currently, there is no law that requires supervision for acupuncture.

On behalf of my patients on medicare, I thank you for your time and consideration. Living with chronic pain in the back can lead to devastation and loss of quality of living. I remember in the early 2000's having a patient with chronic back pain. Her MD said she had an addiction to pain medication and ended her prescriptions. Shortly after, I found out she had passed away. She was in so much pain, I struggled to cope with my feelings of relief for her through death. At that time, I was a lymphatic therapist and I did not know about acupuncture. Today, I know there are more options we can try to help patients to cope with pain.

Thank you very much,

Dr. Erin Murphy

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First, thank you CMS for considering acupuncture as a treatment option for chronic low back pain. Acupuncture has been frequently studied and shown to be an effective treatment option for low back pain. With the current opioid epidemic, it is crucial for patients in the USA to have access to effective non-opioid pain relief, which acupuncture can provide.

I believe that the section that includes "auxiliary providers" should be changed to a clearer and more accurate description. In its place should be "Licensed Acupuncturists or state equivalent." In California, the requirements to be a Licensed Acupuncturists are greater than the national certification (NCCAOM). California requires at least a minimum of 3,000 hours of theoretical and clinical training pursuant to California Code of Regulations, section 1399.434.

In addition, I ask that the supervision during the study portion be done only by an MD. Supervision by other licensure types does not have a precedent, nor does it add in any way to the safety or quality of the trials. Furthermore, supervision in general should only be applied for these specific trials. In California, supervision by a MD or any other licensure type is not required. In 1978 California established acupuncture as a "primary health care profession", which eliminated the requirement for a prior diagnosis or referral by a licensed physician, or dentist. Licensed Acupuncturists (L.Ac.) are considered primary health providers in California. As an example, a Licensed Acupuncturist in California can be designated as primary provider in Workers Comp.

Thank you for your time,

Christopher Lee, L.Ac.

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As being a registered physical therapist and licensed acupuncturist for more than 35 years, I have being treating countless number of low back pain patients. It is very obvious that acupuncture is a very powerful method to manage the pain and help patients to restore a quality life.

I highly welcome the CMS to start this study to look into the effectiveness of acupuncture in chronic low back pain. It can surely will contribute more evidence to the effectiveness of acupuncture.

However, this study requires the certification of National Certification Commission for Acupuncture and Oriental Medicine (NCCA) will virtually exclude the California acupuncturists, as California has its own certification exam. The California exam actually is of higher demand in the candidates' skill and knowledge. Therefore, this exclusion of the California acupuncturists will be a big drawback on the study, as you leave out the highly capable acupuncturists to participate.

Therefore, I respectfully request the study administrators to re-think the participating acupuncturists' qualification, and include the California acupuncturists.

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Dear CMS:

The purpose of this submittal is to, first, thank you for consideration of Acupuncture Coverage for treatment of Low Back Pain; and, second to strongly urge you to change wording in the proposal that reads "auxiliary providers" to more clearly name "Licensed Acupuncurist; or, state equivalent" as the profession of practitioners who are fully trained and qualified to administer this care with the most favorable outcomes read; safety & effectiveness.

The State of Texas requires Licensed Acupuncturists to have 1,800 hours of training to qualify for Board Examinations administered by The National Certification Commission of Acupuncture & Oriental Medicine, with additional Continuing Education, yearly. Others attempting the practice of Acupuncture without these stringent "Entry Level" qualifications fall far short of providing the public with safe and effective treatments.

Additionally, the supervision during the study portion you will undertake should be supervised by done only by an MD. Supervision by other types does not have a precedent nor does it add in any way to the safety or quality of the trials.

Additionally, Texas laws for performing Acupuncture by a Licensed Acupuncturist require no such supervision Acupuncture performed by a Licensed Acupuncturist is deemed safe with no need for this kind of supervision.

If this trial proves favorable for Acupuncture coverage for Low Back Pain under Medicare Guidelines, the safest and most effective treatments for Medicare Recipients will be from Licensed Acupuncturists; not others who do not have the scope and breadth of training.

Thank you for consideration of these comments.
J. Paul PT, L.Ac.

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Ref: National Coverage Analysis (NCA) for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller, Mr Dolan & CMS Committee members,

First, we are grateful to the CMS for conducting a clinic trial investigating acupuncture’s effectiveness to treat chronic low back pain (cLBP) in geriatric patients. We understand the need that federal health care legislators seek further evidence for the effectiveness of acupuncture in order to justify federal coverage with medicare. We would like to shed light on further relevant topics of consideration for the CMS committee members to contemplate.

Traditional Chinese Medicine (TCM) has been an empirical based medicine for over 3,000 years in China. Acupuncture is one tool out of many for a doctor practicing TCM. The theories and etiologies of TCM are the foundation for formulating a diagnosis and treatment. Selecting specific acupuncture points, how to combine them in a treatment and how to manipulate them are based off of the theories and etiologies rooted in TCM. Acupuncture greatly depends on the quality of TCM education the practitioner received, their clinic experience treating patients and the effective results with their modalities of treatment utilized. Effective acupuncture cannot be learned solely in a weekend seminar or via adjunct CEU courses. Furthermore, one cannot obtain the same level of effective results as a qualified TCM practitioner if one is to approach TCM from any other medical frame of mind. A nurse practitioner, physician assistant, M.D., or physical therapist do not possess the understanding or skills of TCM in order to effectively treat a patient with acupuncture in order to resolve pathology, unless they have gone through proper education and training in the theories, etiologies and treatment protocols of TCM.

Regarding the specific topic of cLBP in geriatric patients, it is important to first explain that there are several categories to describe and treat this condition from the point of view of TCM. TCM understands the same problems as described in a wetern medical diagnosis and treats them, yet there is a different understanding as to the description of the etiologies and pathologies, why these pathologies occur and how to approach treatment. It is the goal of the TCM practitioner to stop pain symptoms and then proceed to resolve the underlying pathology. If the techniques of acupuncture are not effective enough then it becomes impossible to stop the pain and move on to treat the root cause.

To help elucidate, here are brief examples of different TCM etiologies and pathologies for cLBP. Typically, a two step treatment protocol is involved, treating the branch (i.e. pain symptoms) and then addressing the root cause (i.e. bone degeneration or poor blood circulation). TCM nomenclature describes a unique understanding of pathophysiological functions in the body.

Pain that presents “horizontally” across the lower back - this is due to the concept of kidney yang and kidney yin deficiency (i.e. constitutional weakness, aging process) or due to the overuse of the kidney’s energy, which in turn depletes the kidney from its normal function (i.e. high sexual activity). Pain that presents “vertically” following the lumbar vertebrae - this may include old injuries due to trauma from sports, an accident or previous surgical interventions. (i.e. scar tissue, bone degeneration, bulging discs) Pain that presents both vertically and horizontally is due to pathological temperature abnormalities in the body, particularly cold & damp. Local climates play a role in this type of pathology (i.e. living in northern climates).

Regarding acupuncture research studies, (with all due respect) a typical research participant tends to lack adequate clinic experience to demonstrate TCM acupuncture effectiveness, albeit, the researchers are highly skilled in academia or in their particular medical field. As a result, the research outcomes do not adequately represent the real effectiveness of TCM acupuncture. This is not a good benchmark or standard from which to base any medical or political decisions from.

To this extent, further research is required to compare the differences of the effectiveness of acupuncture in the hands of a qualified TCM practitioner vs. that of another medical practitioner such as a physical therapist, nurse or M.D. who have received “technical” training in acupuncture needling, or that of another “style” of asian medicine. The purpose of this research is to demonstrate the effectiveness of TCM acupuncture techniques, and to show how when utilizing these techniques, it can more effectively treat patients and helps to create cost savings to the insurance industry and medical field.

We wish for the public to benefit from acupuncture, but in the hands of qualified practitioners. Acupuncture brings with it the potential for supporting millions of people in dealing with cLBP, especially in a time when non-opioid options are more needed. This would save insurance companies a lot of money, help share the burden of over crowded hospitals and provide low cost solutions to chronic pain management.

Thank you for your time and consideration,

Yu Dayi Chinese Medicine Clinic
Shoubin Yu, LAc (17th Generation TCM Practitioner)
Anthony DiSalvo, MSOM graduate

www.yudayimedicine.com

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I think including acupuncture for Low Back Pain in Medicare/Medicaid is a brilliant idea. I think the medical profession will find other ailments treated and alleviated in treating low back pain.

I feel that this needs to be limited to Licensed Acupuncturists. Firstly, this is a deep well of information LAc's have invested in to earn their license. This should be protected. The use of acupuncture needles is only representative to the practitioner's education. Should any other professional earn a certificate to administer these tools, they are still practicing from their own specialty and education. Chinese Medicine is deeply unique and specialized. It makes it hard to standardize — and yet it's richness and history are proven. And requires 3-4 years of study, observation, and internship practice.

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Mr. David Dolan
Susan Miller, MD
U.S. Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

August 7, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan,

The Acupuncture Society of Washington, DC (ASCD) is an organization representing licensed acupuncturists in the District of Columbia and is a member state of the national organization, American Society of Acupuncturists. We greatly appreciate the opportunity to comment on this important Proposed Decision Memo (CAG-00452N).

ASDC sincerely thanks CMS for its forward-looking and very well designed proposal making coverage available for Medicare patients participating in clinical trials of acupuncture for chronic back pain. As acupuncture clinicians, ASDC members routinely help patients greatly diminish, or even resolve, chronic low back pain, with the concomitant decrease in pain medications and medical visits, and significant improvements in quality of life. We are thrilled that CMS is facilitating controlled clinical trials of acupuncture for chronic back pain. We anticipate these trials will make the benefit of acupuncture for this condition more widely known, and ultimately will allow greater access to acupuncture for people who would benefit from it.

We do have concerns about two provisions of the proposal, both of which are related to staffing of the clinical trials. We are concerned that 1) licensed acupuncturists are not explicitly mentioned as personnel permitted to furnish acupuncture in these trials; and 2) licensed acupuncturists participating as "auxiliary personnel" must be supervised by a physician assistant or nurse practitioner/clinical nurse specialist.

The American Society of Acupuncturists (ASA) addressed these issues in a comment letter to you dated July 24, 2019. They provided the rationale for these concerns, and suggested specific revisions to the Proposed Decision Memo. We fully support the ASA's comments and proposed revisions. We would like to offer some additional information as well.

We do not know the concern(s) that led CMS to not explicitly mention licensed acupuncturists as personnel permitted to furnish acupuncture in these trials. We offer the following information, in the hopes that it will help address whatever the concern(s) might be:

* Licensed acupuncturists routinely participate in controlled clinical trials as core members of research teams. For example, several ASDC members have participated in clinical trials at the Walter Reed Army Medical Center. These licensed acupuncturists were charged with developing all of the acupuncture treatment plans and protocols, as well as the quality assurance measures, for a two-arm clinical trial of the efficacy of acupuncture for soldiers suffering from post-traumatic stress disorder (PTSD). The acupuncturists were considered essential core members of the research team. They were never considered, nor treated as, "auxiliary personnel." The study was very well-regarded within the military medical establishment, and it is likely responsible, at least in part, for widening the availability of acupuncture to soldiers suffering from PTSD.

* Licensed acupuncturists on any research team can be expected to exhibit a very high level of knowledge and professionalism, and to provide the core experience and expertise needed for meaningful studies of acupuncture's efficacy. The profession of acupuncture is highly regulated in almost all states, with education and licensing requirements paralleling those of other health professions. For example, in Washington, DC, acupuncture is regulated by the DC Board of Medicine (BOM). The requirements for licensure and bi-annual recertification are essentially identical to all other health care professions regulated by the BOM. Acupuncturists in DC must meet extensive educational requirements, and have at least a masters-level degree. Acupuncturists in DC must be Board-certified by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM), which sets rigorous testing and recertification standards, including testing of biomedical knowledge. Other states have similarly rigorous requirements.

* In most states, licensed acupuncturists act as independent providers. The 1980s-era requirement in Washington, DC for supervision by a medical doctor was removed many years ago, as it was recognized by the Board of Medicine that such supervision was unnecessary and without benefit. There has never been a requirement for supervision by a physician assistant or nurse in DC, nor elsewhere in the country to the best of our knowledge. It is not clear to us how the requirement for supervision by physician assistants or nurses in clinical trials would be beneficial. It does, however, seem that this requirement could unnecessarily constrain the principal investigator by limiting his or her staffing options.

In conclusion, we request that CMS revise the Proposed Decision Memo to:

* Explicitly list licensed acupuncturists (or state equivalents) who carry an active and unrestricted license in their state of practice as providers of acupuncture;

* Remove reference to "auxiliary personnel" as providers of acupuncture; and

* Remove the requirement for supervision by physician assistants or nurse practitioner/clinical nurse specialists.

The July 24, 2019, comments of the ASA provide the rationale for this request. As stated above, ASDC fully concurs with ASA's comments. Our comments offer additional information that we hope will bear on CMS's decision on this matter.

Thank you again for this opportunity to comment, and for your overall very thoughtful, pragmatic approach to studying acupuncture for chronic back pain. If you need additional information, please do not hesitate to contact me at 202-822-1711 or by email at info@dcacupuncture.org

Sincerely,
Dr. Amy Lewis, D.Ac., Dipl. Ac.
President, ASDC

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Thank you CMS for your consideration in this proposal. In the section that includes" auxiliary providers" please change "auxiliary providers" to" Licensed Acupuncturist." I am a licensed acupuncturist in the state of North Carolina with a strict Acupuncture Law requiring three years of formal acupuncture study from an accredited educational institution and passing a series of National Exams given by the National Certification Commission for Acupuncture and Oriental Medicine before the state license is granted. Also, please allow only MDs to provider supervision in the study period.

Thank you.
Michael Carrigan, Licensed Acupuncturist

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David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

July 24, 2019

RE: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Dr. Miller and Mr. Dolan:

On behalf of the American Society of Acupuncturists and our 4500 members nationwide, we applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As representatives of the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, we seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:

• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.¹

The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States,² and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). ³ We propose alternate language for this section in toto that simply reads:

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers⁴ In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

The Board of the American Society of Acupuncturists

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To whom it may concern at CMS,

The state association for acupuncturists in Arizona has informed its members about the following idea:

As a DAOM (Dipl. In Acupuncture and Oriental Medicine) and L.Ac (Licensed Acupuncturist), who works in a community-based MAT clinic, I’d like to thank CMS for such a positive initiative. The proposed research study covering the topic of low back pain is certainly needed, since it is one of the most common health issues we encounter in our daily practice. Making our service available for patients covered by Medicare and Medicaid will be a big step towards a better quality of care.

However, as an acupuncturist, I’d like to make a few comments about certain aspects of our profession, that unfortunately until this day, are not clear to other healthcare providers and the general public. For many years, different state associations have tried to promote our profession, and in many instances, such as is the case in Florida, our scope of practice has reached the level of a primary care physician, honoring the extensive, full-length, accredited education in acupuncture and Oriental medicine we must complete in order for us to be granted with a license. But, in many other instances, our profession is not recognized and even ignored.

The World Health Organization WHO has recognized nine practices of Traditional and complementary medicine (T&CM)¹, including acupuncture, and herbal medicine, the two best known therapies used in Traditional Chinese Medicine (TCM), a practice used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness. Therefore, it is worth noting that as practitioners of TCM, we are trained in acupuncture, Tui Na massage, Qi Gong, herbal medicine, and dietary therapy. To acquire this knowledge, we must attend whether a master’s degree program in acupuncture, which takes a minimum of three years and 1,905 hours of training, or a broader degree in Oriental medicine, which requires four years and 2,625 hours, covering theory and clinical practice, in both, biomedicine and eastern medicine disciplines as well as Chinese herbal studies.

After completing either program, students may apply to sit for a total of four NCCAOM (National Certification Commission for Acupuncture and Oriental Medicine) certification exams, including Foundations of Oriental Medicine, Biomedicine, Acupuncture with Point Location and Herbal Medicine. The NCCAOM board certification is required in 22 states, and their examinations are used in the remaining states to issue a license to practice acupuncture.

NCCAOM has also pointed out “Like any medical discipline, the safe and effective practice of acupuncture requires carefully trained professionals. NCCAOM National Board-Certified Acupuncturists undergo a training and competency verification program in sharp contrast to the less rigorous acupuncture training of non-specialized health care professionals such as chiropractors, registered nurses, or even medical doctors. These other professions typically receive at most 100-300 hours of abbreviated training and treat a limited number of pain points. NCCAOM National Board-Certified Acupuncturists are also trained in standard medical history gathering, safety, and ethics, as well as the proper methods and procedures for referring patients to outside professionals and consulting with non-acupuncturist practitioners”.²

Due to our rigorous clinical training, TCM practitioners from every corner of the country have actively pursued the proper incorporation of our profession and the practice of acupuncture into the mainstream healthcare system. Thus, when I read the proposal to conduct a study in populations covered by Medicare, I felt that a couple of things deserve to be reviewed and hopefully, changed. For instance:

It will be most appropriate to use the term “Licensed Acupuncturists or state equivalent”, instead of “auxiliary providers”, which may create confusion and somehow demotes our profession.

Furthermore, the proposal reads:

“Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist”.

As Licensed Acupuncturists, we are, in all but a very limited number of incidences, independent providers nationally, and we have an outstanding safety profile. In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. This means, in most states we are independent practitioners. While it is completely understandable that requiring the supervision of an MD, NP, PA or DO, may be adequate only to conduct a study, it is also true that any of those healthcare providers invested with that responsibility should be also licensed acupuncturists, which will guarantee patient safety, excellence in study design or provision, or any other aspect of the process, and accuracy and quality of the study.

Thank you for the opportunity to comment and for your consideration. I am thrilled to see entities like CMS doing such diligent work to study acupuncture, as it stands as one of the most promising options for non-pharmacological treatments for pain.

Best regards,

Lucy Marulanda, DAOM L.Ac
Arizona LAC # 001132

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[PHI Redacted] I applaud efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. As my colleagues in the Licensed Acupuncturist (L.Ac.) community and other relevant stakeholders affected by the decisions made based on the outcomes of the planned studies, I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxillary personnel may furnish acupuncture if they meet all applicable state requirements and have: A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM); a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and maintained licensure in a U.S. state or territory to practice acupuncture.

This language creates a number of problems and is not consistent with existing law in most locales. Specifically, there are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation. The language as it stands simply obscures the titling of an already existing, designated licensure group. It seems to attempt to give allowance for participation to providers who would not otherwise qualify for inclusion, unless they were already Licensed Acupuncturists.

The current framing also creates problems for qualified Licensed Acupuncturists who have trained overseas, as well as California based Licensed Acupuncturists, who represent approximately one-third of those in the United States, and who have passed an equivalent examination: the California Acupuncture Licensing Exam (CALE). We propose alternate language for this section in toto that simply reads:

Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

This approach would eliminate all confusion and conflicts with state laws, while being more inclusive of the full, qualified licensure group. This bullet could also be simply added to the existing list above, should preservation of that language be desired.

Further, we ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

While we understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

In the state of Pennsylvania, Licensed Acupuncturists formerly were under physician-supervision until 2002 and then required to have physician-referral until 2006. The current Pennsylvania statute can be found here: https://www.pacode.com/secure/data/049/chapter18/subchapbtoc.html
Thank you for the opportunity to comment and your consideration. We are delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely.
Nelson Van Fleet

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Thank CMS for consideration of the Acupuncture for Chronic Lower Back Pain Study. This represents a big step towards the incorporation of acupuncture into national health care.

Please change the section that reads: “Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist”.

The section that includes “auxiliary providers” should be changed to: “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describes this licensure group.

Florida law chapter 457 requires Licensed acupuncturists to perform acupuncture treatment. Licensed acupuncturists are primary health care providers and do not require supervision of “a physician, physician assistant, or nurse practitioner/clinical nurse specialist”. Currently under Florida laws the “physician assistant, or nurse practitioner/clinical nurse specialist” are not allowed to practice acupuncture. Not many MDs have acupuncture training. There simply are not enough MDs with Acupuncture training available to supervise licensed acupuncturists while they perform acupuncture treatment to ensure the safety or quality of the trials? Physician assistants, or nurse practitioner/clinical nurse specialists are not qualified to supervise licensed acupuncturists while they perform acupuncture treatment to ensure the safety or quality of the trials.

Please alternate language for this section in total that simply reads: “Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state to practice acupuncture may provide acupuncture.”

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August 11, 2019

RE: Acupuncture for Chronic Low Back Pain (CAG-00452N)

Dear Mr. Dolan and Dr. Miller:

I am a licensed acupuncturist in California and nationally certified by the NCCAOM diplomate in Oriental Medicine. I practice in Los Angeles. Thank you for requesting comments regarding efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. While many licensed California acupuncturists are additionally certified by the NCCAOM, current state law does not require this for licensure or practice. The California Acupuncture Licensing Exam (CALE) has been certified to be equivalent to the NCCAOM certification exams by the NCCAOM itself. Our state’s licensure requirement of 3,000 hours of didactic and clinical training exceeds the minimum NCCAOM certification requirements as adopted by most other states. Although California has more licensed acupuncturists than any other state, more required training than most other states, and certified exam equivalency, the current framing excludes over 10,000 qualified active California licensed acupuncturists while creating ambiguity with use of the term “auxiliary personnel” in its proposed decision memo.

Only five designated licensures are permitted to practice acupuncture in California: licensed acupuncturists, physicians and surgeons (without additional certification), and dentists and podiatrists who have also completed a certification course in acupuncture. All other licensures are prohibited from practicing acupuncture unless they also hold an acupuncture license. This prohibition includes Physical Therapists, Physician Assistants, nurse practitioners, and clinical nurse specialists. State law also specifically prohibits supervision of acupuncturists by physicians, dentists, or podiatrists for training or tutorial purposes unless they are also a licensed acupuncturist. Thus, the use of “auxiliary providers” seems to attempt to allow participation by providers who would not otherwise qualify for inclusion unless they were already licensed acupuncturists, while excluding over 10,000 qualified licensed acupuncturists in California and more than a quarter of all licensed acupuncturists in the USA.

I propose the following replacement text:

Licensed acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture. Instead of the current proposed text:

• Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:
  • A masters or doctoral level degree in acupuncture or Oriental Medicine
  • from a school accredited by the Accreditation Commission on
  • Acupuncture and Oriental Medicine (ACAOM);
  • a current certification by the National Certification Commission for
  • Acupuncture and Oriental Medicine (NCCAOM); and
  • maintained licensure in a U.S. state or territory to practice acupuncture.

Acupuncturists have more training in this specialty than any other designation, and we have obtained the unique Bureau of Labor Statistics (BLS) designation 29 1199.01 Acupuncturist. I request that the term “licensed acupuncturists” be used and included, where appropriate, in all data collected and reported from these studies and in all documentation related to recruiting, study methods, and other coverage based on the outcomes of the studies requested by CMS. Those decisions should be based on the actual provision of care which would include not only the number of treatments and the techniques prescribed, but also the training, licensure and proper designation of the providers of this service.

It is inconsistent with California state law that licensed acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. As mentioned previously, certain aspects of California law prohibit supervision of acupuncturists by professionals who are not themselves licensed acupuncturists. There is no precedent for the inclusion of these professionals as supervisors of acupuncturists, nor does it improve patient safety, study design or provision, or any other aspect of the validation, assessment, or decision-making process of this effort. Licensed acupuncturists have an outstanding safety profile documented in all states regulating licensure. We ask that the terms “physician assistant” and “nurse practitioner/clinical nurse specialist” be removed in order to revise this portion for consistency with state laws.

Thank you for your consideration of our comments and for providing this opportunity.

Sincerely,
Michael L. Fox, PhD, LAc, Diplomate of Oriental Medicine (NCCAOM)
Silverlake Acupuncture, Inc.
www.SilverlakeAcupuncture.com

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August 4, 2019

David Dolan
Susan Miller, MD
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Miller and Mr. Dolan:

On behalf of the California Acupuncture and Traditional Medicine Association (CalATMA), our members, and the 12,185 licensed acupuncturists in the state of California, we commend the efforts by CMS to study the effects of acupuncture for chronic low back pain (cLBP) in populations covered by Medicare. We would like to thank the CMS for its consideration of this topic which represents an important step towards the incorporation of acupuncture into national health care.

California licensees represent nearly one-third of all licensed acupuncturists (LAcs) in the USA(1) . Along with other relevant stakeholders who will be affected by the decisions made based on the outcomes of these planned studies, we are concerned about problems created by the language of the proposed decision memo and inconsistencies with existing law. We are seeking clarification on several issues as outlined below.

While 2,147 licensed California acupuncturists are additionally certified by the NCCAOM(2), current state law does not require NCCAOM certification for licensure or practice, nor does it require supervision by an MD. The California Acupuncture Licensing Exam (CALE) has been certified to be equivalent to the NCCAOM certification exams by the NCCAOM itself, following extensive independent authentication(3). Our current educational requirement of 3,000 hours of didactic and clinical training exceed the minimum NCCAOM requirements as adopted by 47 states and District of Columbia. Although California has more licensed acupuncturists than any other state, more required training than most other states, and certified exam equivalency, the current framing excludes 10,038 qualified active California licensed acupuncturists while creating ambiguity with use of the term “auxiliary personnel” in its proposed decision memo.

State laws and regulations designate our LAcs as primary healthcare physicians in the arena of Workers Compensation(4) in Labor Code Division 4 §3209.3 (5) and specifically allow acupuncturists to practice autonomously as independent providers without direct or indirect supervision by an MD or any other supervisor. Only five designated licensures are permitted to practice acupuncture in California: LAcs, physicians and surgeons (without additional certification), and dentists and podiatrists who have also completed a certification course in acupuncture . All other licensures are prohibited from practicing acupuncture unless they also hold an acupuncture license. This prohibition includes Physical Therapists, Physician Assistants, nurse practitioners, and clinical nurse specialists. State law also specifically prohibits supervision of acupuncturists by physicians, dentists, or podiatrists for training or tutorial purposes unless they are also a licensed acupuncturist. Thus, the use of “auxiliary providers” seems to attempt to allow participation by providers who would not otherwise qualify for inclusion unless they were already LAcs, while excluding 10,038 qualified LAcs who have met and/or exceeded licensing and education standards in California. This represents an exclusion of about 26% of all eligible, qualified acupuncturists in the USA.

Therefore, regarding the following text of the proposed decision memo, as follows:

• Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:
  • A masters or doctoral level degree in acupuncture or Oriental Medicine
  • from a school accredited by the Accreditation Commission on
  • Acupuncture and Oriental Medicine (ACAOM);
  • a current certification by the National Certification Commission for
  • Acupuncture and Oriental Medicine (NCCAOM); and
  • maintained licensure in a U.S. state or territory to practice acupuncture,

we propose alternate language for this section in toto as follows:

• Licensed acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

We strongly object to the term “auxiliary personnel” as the default term for licensed acupuncturists, who have obtained the unique Bureau of Labor Statistics (BLS) designation 29 1199.01 Acupuncturist, especially since we collectively have more training in this specialty than any other designation. We request that the term “licensed acupuncturists” be used and included, where appropriate, in all data collected and reported from these studies and in all documentation related to recruiting, study methods, and other coverage based on the outcomes of the studies requested by CMS, so that those decisions should be based on the actual provision of care which would include not only the number of treatments and the techniques prescribed, but also the training, licensure and proper designation of the providers of this service. The State of California performs a periodic occupational analysis of acupuncturists and has determined that adequate safety, training, performance and experience exists to protect the public in the areas of Patient Assessment, Diagnostic Impression, Acupuncture Treatment, Herbal Therapy, and Regulations for Public Health and Safety (7).

While we understand the need for direct supervision by a physician during the official research study, it is inconsistent with California state law and with every other state law that licensed acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. As mentioned previously, certain aspects of California law prohibit supervision of acupuncturists by professionals who are not themselves licensed acupuncturists. There is no precedent for the inclusion of these professionals as supervisors of acupuncturists, nor does it improve patient safety, study design or provision, or any other aspect of the validation, assessment, or decision-making process of this effort. Licensed acupuncturists have an outstanding safety profile documented in all states regulating licensure. We ask that the terms “physician assistant” and “nurse practitioner/clinical nurse specialist” be removed in order to revise this portion for consistency with state laws.

Thank you for your consideration of our comments and for providing this opportunity. Acupuncture stands as one of the most promising options for the non-pharmacological treatment of pain when practiced by licensed acupuncturists, and we are exuberant to see CMS begin its diligent work in this study.

Sincerely,

The Board of Trustees of California Acupuncture and Traditional Medicine Association

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Acupuncture is one of the best options for Chronic lower back pain, we have been using acupuncture treated thousands and thousands these kind patients and achieved very positive results.

12 weeks trail is good designation.

The qualification of the providers are important, Acupuncture license in that state should be the basic requirement which can ensure the safety and the treatment effects.

Also please put the acupuncturists into the CMS system.

Thank you

Dr Haihe Tian

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To Whom It May Concern,
Many thanks to Medicare and Medicaid ( CMS) for considering to study the research and possibly include acupuncture for low back pain for Medicare payment. Rather than have auxiliary providers performing acupuncture, however, I believe that only State and nationally licensed acupuncturists and Medical Doctors with acupuncture training should administer acupuncture services in the future. In most states, acupuncture study requires a four year course of study, supervision for one year by a licensed acupuncturist, and passage of extensive written, oral and practical exams in order to be certified. For this reason, only LIcensed Acupuncturists and Medical Doctors with specialized certification in acupuncture should provide acupuncture services. And during this research and study period, I strongly believe that only Medical Doctors should be supervising acupuncturists for safety and research purposes.

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I want to thank CMS for consideration of the Acupuncture for Chronic Lower Back Pain Study. This represents a big step towards the incorporation of acupuncture into national health care.

Please change the section that reads: “Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist”.

The section that includes “auxiliary providers” should be changed to: “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describes this licensure group.

Florida law chapter 457 requires Licensed acupuncturists to perform acupuncture treatment. Licensed acupuncturists are primary health care providers and do not require supervision of “a physician, physician assistant, or nurse practitioner/clinical nurse specialist”. Currently under Florida laws the “physician assistant, or nurse practitioner/clinical nurse specialist” are not allowed to practice acupuncture. Not many MDs have acupuncture training. There simply are not enough MDs with Acupuncture training available to supervise licensed acupuncturists while they perform acupuncture treatment to ensure the safety or quality of the trials? Physician assistants, or nurse practitioner/clinical nurse specialists are not qualified to supervise licensed acupuncturists while they perform acupuncture treatment to ensure the safety or quality of the trials.

Please alternate language for this section in total that simply reads:

• “Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state to practice acupuncture may provide acupuncture.”

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I want to thank CMS for consideration of the Acupuncture for Chronic Lower Back Pain Study. This represents a big step towards the incorporation of acupuncture into national health care.

Please change the section that reads: “Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist”.

The section that includes “auxiliary providers” should be changed to: “Licensed Acupuncturists or state equivalent”. The qualifications for auxiliary providers exactly describes this licensure group.

Florida law chapter 457 requires Licensed acupuncturists to perform acupuncture treatment. Licensed acupuncturists are primary health care providers and do not require supervision of “a physician, physician assistant, or nurse practitioner/clinical nurse specialist”. Currently under Florida laws the “physician assistant, or nurse practitioner/clinical nurse specialist” are not allowed to practice acupuncture. Not many MDs have acupuncture training. There simply are not enough MDs with Acupuncture training available to supervise licensed acupuncturists while they perform acupuncture treatment to ensure the safety or quality of the trials? Physician assistants, or nurse practitioner/clinical nurse specialists are not qualified to supervise licensed acupuncturists while they perform acupuncture treatment to ensure the safety or quality of the trials.

Please alternate language for this section in total that simply reads:

As a Licensed Acupuncturist (L.Ac.), I seek clarification on certain aspects of the decision memo recently issued. The text of greatest relevance is highlighted below:

Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:
"A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM); a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and maintained licensure in a U.S. state or territory to practice acupuncture."

How could you do a study on acupuncture for back pain when you are not stating CLEARLY that it is to be performed by Licensed acupuncturists only? Our profession is standardized and there are requirements of licensure to be earned.

There are no PAs, NPs or clinical nurse specialists who would meet these requirements and not also qualify to be a “Licensed Acupuncturist or state equivalent”. These individuals, if there are indeed any, would most likely hold dual licensure as a PA/NP/CNS and as a Licensed Acupuncturist. Graduation from an ACAOM accredited school and passing of the NCCAOM certification exams defines the core of this specific licensure group, which also obtained a unique Bureau of Labor Statistics (BLS) designation.

Licensed Acupuncturists or state equivalents who carry an active and unrestricted license in the state of practice may provide acupuncture.

I ask that the term “licensed acupuncturist” be included, where appropriate, in all data collected and reported from these studies. It is important to highlight the professionals providing the service in the studies for clarity and proper reporting of study methods. Future decisions on coverage will be made based on the outcomes of the studies requested by CMS, so those decisions should be based on the actual provisions of care including not only techniques used and number of treatments, but also including the training of the providers of the service.

"Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist."

WHY? While I understand the need for direct supervision by a physician during trial purposes, it is inconsistent with every state law that Licensed Acupuncturists be under the direct supervision of physician assistants, nurse practitioners or clinical nurse specialists. There is no precedent for this, nor does it improve patient safety, excellence in study design or provision, or any other aspect of the process. Licensed Acupuncturists are, in all but a very limited number of incidences, independent providers nationally, and have an outstanding safety profile. In Hawaii, for example, only Licensed Acupuncturists (not even medical doctors) can provide acupuncture. In cases where they were or remain under supervision, only medical doctors have been in that supervisory position. We ask that this portion be revised to be consistent with state laws, and remove the terms “physician assistant” and “nurse practitioner/clinical nurse specialist”.

Thank you for the opportunity to comment and your consideration. I am delighted to see CMS doing such diligent work to study acupuncture for pain, as it stands as one of the most promising options for non-pharmacological treatment.

Sincerely,
Ann Federowicz, Lac.

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