National Coverage Determinations Proposed for Removal (November 2013)

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) list of National Coverage Determinations Proposed for Removal. America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

General Comments

AHIP and our member health plans encourage CMS to ensure that all patients receive safe, effective and evidence-based healthcare services. Our members support an expedited administrative process by CMS, using specific transparent criteria, to remove National Coverage Determinations (NCDs) that were last reviewed 10 years ago or more. Upon reviewing the list of 10 services CMS proposed to retire, our members support retiring these 10 NCDs. Our members agree with CMS that this streamlined process is a more efficient way to monitor national policies and ensure health benefits for Medicare beneficiaries remain current.

Thank you for the opportunity to comment on this important issue.

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December 23, 2013

Marilyn Tavenner
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mail Stop 314G
200 Independence Avenue, S.W.
Washington, DC 20201

Dear Administrator Tavenner,

The American Academy of Dermatology Association (AADA) represents more than 17,000 practicing dermatologists in the United States. The AADA is committed to excellence in medical and surgical treatment of skin disease, advocating high standards in clinical practice, education, and research in dermatology and dermatopathology while supporting and enhancing patient care to reduce the burden of disease. We would like to provide comments in response to the Centers for Medicare and Medicaid Services (CMS) publication notice 78 FR 48164-69 published in the August 7, 2013 edition of the Federal Register related to the updating process used for opening, deciding, or reconsidering national coverage determinations (NCD).

At this time, the AADA would specifically like to focus our comments on NCD 140.5 Laser Procedures. This NCD has an effective date of 5/1/1997. The AADA respectfully requests that CMS reconsider its position on the proposed removal of this NCD. The AADA has remained proactive in addressing the proper use of laser procedures through continuing medical educational meetings, practice management resources and workshops. Also the AADA has worked continuously at the level of the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) and RBRVS Update Committee (RUC) panels addressing topics of concern to the practice of Dermatology. We share a dedication towards providing the most appropriate and effective medical services to Medicare beneficiaries. The removal of NCD 140.5 would adversely impact a significant number of Medicare beneficiaries who benefit from medically necessary laser procedures when afflicted with severe diseases and conditions such as psoriasis, malignant skin lesions, vascular lesions, vitiligo, poikiloderma, dermatitis, rosacea, recalcitrant human papilloma virus lesions and nail fungus.

There are few, if any Local Coverage Determinations (LCDs) that focus on Laser Procedures. For that reason, NCD 140.5 is the best and most appropriate guide currently in use. The AADA agrees with the outline of indications and limitations of NCD 140.5 currently in place to determine coverage. Additionally this NCD does not affect or require any new related coding changes. The AADA strongly agrees that coverage of laser procedures should remain restricted to practitioners with training in the surgical management of the disease or condition being treated. To ensure that patients receiving laser procedures are treated by physicians with the highest medical training and education, we are attaching to this letter the American Academy of Dermatology’s (AAD) Position Statement on The Practice of Dermatology: Protecting and Preserving Patient Safety and Quality Care. This Position Statement outlines the scope of practice of Dermatology and is the guiding principle for all dermatologists to practice ethical medicine with the highest possible standards to ensure that the best interests and welfare of each patient are guaranteed.

Once again, the AADA would like to respectfully request that CMS reconsider its decision to remove NCD 140.5 and furthermore provide an active status to this national policy. This NCD can be found on CMS’ NCD Database http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx and is also being added to this letter as an attachment.

We look forward to further discussing this topic should additional information be requested or needed. Please contact Ana Maria Bustos, Senior Manager of Coding and Reimbursement, at 847-240-1814 or abustos@aad.org if we can provide clarification on our comments.

Sincerely,

Dirk M. Elston, MD, FAAD
President, American Academy of Dermatology Association

CC:
Lisa A. Garner, MD, FAAD, Vice President
Brett M. Coldiron, MD, FAAD, President-Elect
Suzanne Olbricht, MD, FAAD, Secretary-Treasurer
Marta Jane VanBeek, MD, MPH, FAAD, Chair, Council on Government Affairs, Health Policy, and Practice
Elaine Weiss, JD, Executive Director and CEO

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December 27, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Determinations (NCDs) Proposed for Expedited Removal

Dear Dr. Jacques:

The American College of Cardiology (ACC) is transforming cardiovascular care and improving heart health through continuous quality improvement, patient-centered care, payment innovation and professionalism. The College is a 43,000 member nonprofit medical society comprised of physicians, nurses, nurse practitioners, physician assistants, pharmacists and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at http://www.cardiosource.org/ACC.

The ACC appreciates this opportunity to comment on the NCDs proposed for expedited removal according to CMS’ newly defined process. We find review of policies more than 10 years old in this fashion is a commonsense approach. Interested parties can suggest reasons an NCD should be retained, request a complete reconsideration of the NCD with all it entails, support CMS’ proposed removal, or tacitly support CMS’ proposed removal by remaining silent.

The removal of NCD 20.17 for Noninvasive Tests of Carotid Function seems appropriate for most of the services it describes. However, one could also interpret removal of services described as “Doppler flow velocity,” “Ultrasound Imaging including Real Time,” or “B-Scan and Doppler Devices” to mean that national coverage for a service commonly used to diagnose patients with carotid stenosis was removed. It would be incorrect for CMS to remove coverage for duplex scan of extracranial arteries (CPT codes 93880 and 93882).

Fortunately, it appears these services should still be covered under NCD 220.5 for Ultrasound Diagnostic Procedures. If CMS intends to continue covering carotid duplex studies under NCD 220.5, we suggest it would be reasonable to remove NCD 20.17. Other than carotid duplex studies, NCD 20.17 describes services for which coverage determination can be appropriately made by contractors. When the proposal to remove NCD 20.17 is finalized, we request CMS specifically state that coverage for duplex scan of extracranial arteries will continue under NCD 220.5.

Thank you for your time and consideration. If you have questions or require additional information, please contact James Vavricek, Senior Specialist for Regulatory Affairs, at 202-375-6421 or jvavricek@acc.org.

Sincerely,

John Gordon Harold, MD, MACC, MACP, FESC, FCCP, FAHA
President

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The American Academy of Audiology is the world's largest professional organization of, by, and for audiologists, representing nearly 12,000 members. The American Academy of Audiology (the “Academy”) promotes quality hearing and balance care by advancing the profession of audiology through leadership, advocacy, education, public awareness, and support of research.

The Academy appreciates the opportunity to comment on the retirement of the CMS tinnitus masking National Coverage Determination (NCD). The Academy supports retirement of the tinnitus masking NCD in light of the fact that the current evidence indicates that tinnitus maskers are not experimental. The Academy would be happy to provide CMS with the applicable research studies upon request.

Thank you for the opportunity to provide comment on this important matter.

Sharmila Sandhu,Esq.
American Academy of Audiology

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December 23, 2013

The Honorable Marilyn B. Tavenner
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building, Room 445-G
200 Independence Avenue, SW
Washington, DC 20201

RE: NCD Manual Citation 160.17 – L-DOPA

Dear Ms. Tavenner,

The Parkinson’s Action Network (PAN), on behalf of the undersigned organizations and clinical experts, appreciates the opportunity to provide comments on the National Coverage Determination (NCD) decision for L-DOPA (NCD Manual Citation 160.17), published on November 27, 2013 on CMS.gov. PAN supports retaining L-DOPA’s NCD for diagnostic laboratory tests, inpatient hospital services, and outpatient physical therapy services as outlined in citation 160.17.

As a community, we support the continued accessibility of clinically proven effective treatments, like L-DOPA, for the estimated 500,000 to 1 million Americans living with Parkinson’s disease, a progressive, neurodegenerative disorder for which there is no cure.

Since its discovery and initial application over 40 years ago, L-DOPA has been hailed as the “gold standard” of therapy to ease the symptoms of people diagnosed with Parkinson’s disease. It continues to be part of an established treatment regimen, and as recognized by the current NCD, may be utilized in a variety of diagnostic and treatment scenarios.

Presently, the NCD places limitations on L-DOPA coverage for the specific indications listed in 160.17 to ensure that services are not covered unless they meet a standard of medical necessity. We see no reason to further limit the accessibility of these services by removing 160.17 from the NCD, effectively mandating localized coverage determinations. Because Parkinson’s disease affects each individual differently, it is critical that CMS preserves national coverage for certain L-DOPA services to ensure that all members of the Parkinson’s community have covered access regardless of geographic location.

Thank you once again for the opportunity to provide comments as you consider this important proposal. Please do not hesitate to contact me at arick@parkinsonsaction.org or PAN’s Senior Government Relations Manager, Jamie Tucker (jtucker@parkinsonsaction.org), with any questions.

Sincerely,

Amy Comstock Rick, CEO, Parkinson’s Action Network

Todd Sherer, PhD., CEO, The Michael J. Fox Foundation for Parkinson’s Research

Joyce A. Oberdorf, President and CEO, National Parkinson Foundation

Carol J. Walton, CEO, The Parkinson Alliance

Michael J. Aminoff, MD, DSc, FRCP, University of California, San Francisco

Nina M. Browner, MD, University of North Carolina, Chapel Hill

Robert E. Burke, MD, Alfred and Minnie Bressler Professor of Neurology, Columbia University Medical Center

Thomas L. Davis, MD, Vanderbilt University

Alessandro Di Rocco, MD, New York University

Ariel Deutch, PhD., Vanderbilt University

Albert Yung-Pai Hung, MD, PhD., Harvard University

Joseph Jankovic, MD, Baylor College of Medicine

Zoltan Mari, MD, Johns Hopkins University

John C. Morgan, MD, PhD., Georgia Regents University

Michael S. Okun, MD, University of Florida

Fernando Pagan, MD, Georgetown University

Rajesh Pahwa, MD, University of Kansas

Peter Schmidt, PhD., National Parkinson Foundation

Tanya Simuni, MD, Northwestern University

Carlos Singer, MD, University of Miami

Mark Stacy, MD, Duke University

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December 26, 2013

Centers for Medicare & Medicaid Services
Director, Coverage and Analysis Group
7500 Security Blvd.
Baltimore, MD 21244

RE: List of National Coverage Determinations Proposed for Removal

Director:

We appreciate the opportunity to comment on the List of National Coverage Determinations Proposed for Removal. Our company, Trimedyne, is a manufacturer of lasers and disposable fiber optic delivery services for use in a variety of surgical applications. The company was founded in 1980 and has been actively developing new products to deal with age-related illnesses and medical conditions that impact millions of lives.

We are very supportive of CMS’ efforts to expedite the coverage review process and to ensure that all existing NCDs continue to be clinically pertinent. It is our understanding that the intent of the review of the NCDs that are older than 10 years since their most recent review is to identify those policies where: 1) local contractor discretion will better serve the needs of Medicare beneficiaries; 2) the technology is generally acknowledged to be obsolete and no longer marketed; 3) the NCD has been superseded by subsequent Medicare policy; or 4) the benefit category determination is no longer consistent with a category in the Act.

We do not believe this is the case with the proposed removal of NCD 140.5 Laser Procedures. Moreover, we believe the removal of this NCD will have serious negative consequences for Medicare beneficiary access to the safest, most cost-effective treatment options available. The use of lasers for a variety of surgical procedures has become a standard part of generally accepted medical practice in the US. In 2007 the American College of Surgeons adopted a policy statement indicating “surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is a part of the practice of medicine. The American College of Surgeons believes that surgery using lasers, pulsed light, radiofrequency devices, or other means is a part of the practice of medicine and constitutes standard forms of surgical intervention.”

The presence or absence of national coverage determinations has a significant impact on the availability of state-of-the-art procedures for the Medicare population. In a study of the impact of the NCD on bariatric surgery, the authors concluded that the NCD resulted in improved outcomes for Medicare beneficiaries, including shorter lengths of stay and reduced complication rates(1). While no data exists on the specific impact of the Laser Procedures NCD, laser technology has been proven time and again in clinical studies to provide patients with a less invasive, less costly and more effective alternative to traditional surgical techniques. Removal of the NCD will jeopardize patient access and could result in increased expenditures for the Medicare program.

In a study conducted on Laser Assisted Disc Decompression (LADD) in the Medicare population(2), it was found that LADD resulted in an 80% success rate for Medicare patients undergoing treatment of non-sequestered herniated nucleus pulposus, which is comparable or better than outcomes cited in previous literature for traditional surgical methods. LADD offered the elderly the opportunity to have the surgery on an outpatient basis under local anesthesia with a shorter recovery time and faster return to activity than would have been possible with an open laminectomy. The cost of surgical care for a single level LADD procedure is estimated at one-third the cost of a single level lumbar excision.

Laser surgery has been shown to have significant advantages across a variety of specialties including urology, orthopedics, ENT, gynecology, GI and general surgery. Its advantages, documented in clinical literature, include:

• significantly lower cost
• same-day surgery
• less trauma physically and psychologically
• small incision and less scaring
• reduced likelihood of readmissions
• minimum blood loss
• no significant dissection of muscle, bone, ligament
• local anesthesia
• less challenging to medically high risk and obese patients
• no significant incidence of infection
• minimal use of analgesics postoperatively

Removal of the Laser Procedures NCD may result in limited and inconsistent access to procedures that have been proven to be highly cost effective for the Medicare population. We view this as a significant step backwards for a technology that has been vetted in clinical studies and has become a standard of care for beneficiaries across the country. In addition, it is likely to result in a significant increase in Medicare costs. It will also place a significant burden on local carriers to make decisions on innumerable laser procedures that could result in further delays for patients and increased administrative expense for the Medicare program. We do not believe the removal of the NCD will accomplish any of the goals that were intended as part of the NCD review and removal recently promulgated by CMS. We urge CMS to reconsider its decision to remove the NCD.

Regards,

Glenn Yeik
President & COO
Trimedyne, Inc.

(1) Improved Bariatric Surgery Outcomes for Medicare Beneficiaries After Implementation of the Medicare National Coverage Determination, Ninh T. Nguyen, MD, et.al. JAMA Surgery, January 2010, Arch Surg 2010; 145(1): 72-78.
(2) Laser Assisted Disc Decompression: An Alternative Treatment Modality in the Medicare Population. G. David Casper, MD. et.al. J Okla State Med Assoc., Vol 89, January 1996, page 11-15

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