Response to Comments: DL37228 Wound Care

The research on diabetic ulcers is undeniable. Thousands of our patients will suffer delayed healing and increased infection risk with many leading to amputation. I understand the need to reduce overuse of certain procedures but an outright denial of all payments is not the way. Study why the codes are being overused and what can be done to reimburse adequately for the visits and there would be no need for the ban. The knowledge, advanced dressings needed and skill required for a wound care visit far outweighs the payment allowed for a focused office visit. Fix the reimbursement problems and the debridement issue disappears. Dr. James McGuire Clinical Professor and Wound Center Director Temple University School of Podiatric Medicine Philadelphia Pa.

Diabetic Foot Ulcers (DFUs) have always been included for coverage under neuroischemic ulcerations. There is nothing in the draft LCD regarding outright non-coverage of debridement for DFU nor was that the intent. The question on the reconsideration was should DFUs be labeled for coverage IN ADDITION to the already accepted neuroischemic ulcers. The underlying premise being DFU is a type of neuroischemic ulcer. For clarity, DFUs have been added to the LCD L37228 Wound Care under listed covered conditions for debridement. ICD-10 codes for diabetic foot ulcers remain covered in Group 1 Codes in A55909 Billing and Coding: Wound Care.

Someone was asleep when you came up with this one. It borders on patient abuse! Infections, admissions, amputations, will skyrocket. You are out of touch to even consider this. Bryan C. Markinson, DPM

Comments are non-specific and do not reference what part of the LCD they have concerns over. The comments are not of value to the reconsideration request.

WPS has proposed a Wound Care LCD that says debridement is NOT NECESSARY & NOT COVERED for:
1. Diabetic foot ulcers
2. Stage II pressure ulcers
3. ANY ulcer not deeper than the layer of skin
I am commenting on this proposal. Removing calloused skin before they become ulcers is a minor procedure that keeps the patient active and healthy. It is preventive and effective.    Debborah Burch

The comment does not provide supportive literature to address the diabetic foot ulcers or Stage II ulceration concerns. The reconsideration does not discuss treatment of calluses.

On behalf of the physicians at Siouxland Podiatry (Dr. Greg McCarthy, Dr. Marty Kelley and Dr. Sara Oelke) I would like to express our concern over LCD Wound Care L37228 and would like your reconsideration on this matter.

This LCD no longer covers debridement that is necessary for chronic, non-pressure ulcers (not all diabetic patients with ulcers have neuropathy) and for Stage II pressure ulcers. This can potentially increase the likelihood of poor patient outcomes as well as increase overall costs (due to worsening wounds, infection, amputation, hospitalizations).

Ulcers “limited to the breakdown of skin” should also be included.

Debridement is medically necessary for any Stage II ulcer, any diabetic foot ulcer and other chronic, non-pressure ulcers with a severity “limited to breakdown of skin” when devitalized tissue is present. Extensive research has proved this.         Greg McCarthy, DPM, FACFAS

The comments are understood and WPS agrees. DFUs have to this point been approved for debridement and categorized under neuro and ischemic ulceration. It is clear there is consensus not all DFU fall into those categories. See the final LCD for changes in coverage to include DFU (now formally listed) and Stage II pressure ulcers.

I am writing in regard to an online post I read which stated that debridement for diabetic foot ulcers, stage 2 pressure ulcers and others were no longer going to be paid services. Is this true? As a podiatrist /wound care specialist who sees these patients daily, I can’t stress enough the importance of routine wound debridement in wound healing. If true, I fear many patients will be placed at unnecessary risk of inadequate wound care, which leads to greater risk of limb loss and mortality. Glenn Aufseeser, DPM, FAPWCA, CWSP

This comment shows the misunderstanding to the proposed LCD. The draft LCD reflected NO CHANGE to the existing LCD that has been in publication. Stage II pressure ulcers have not been included because of a lack of evidence (to this point) to support the need for debridement. Nothing in this draft LCD was changing that stance, rather affirming the previous stance. DFU have been covered when coded under neuro/ischemic ulceration. DFU are not being removed from the LCD. The reconsideration request was to add the terminology specific to DFUs in addition to the neuroischemic ulcers. These comments have been accepted and this change will happen. See the final LCD publication.

Thirty of the following template comments were received from: Ann Heiman, MPT, MBA; Sharon L.Dunn, PT, PhD; Heather Willemssen, RN; Denise Van Zee, Billing and Scheduling; Nicolle Samuels, MSPT, CLT-LANA, CWS, CKTP; Steven Blom, DPT; Danielle J. Rowland, OTD, OTR/L; Brock Bills, DPT; Sara Nelson, PT, DPT; Travis Bolstad, PT, DPT; Haley Jorgensen, SPT3; Justine Van Zee SPT-3; Ali Deering, SPT-3 Colton Johnson, SPT-1; Abby Mettler SPT, M.Ed, ATC; Ember Newman, SPT2; Courtney Kirkeide University of South Dakota DPT '20; Glen Zevenbergan; Karen Bock, PT, MPT; Elaine Armantrout, PT, DSc; Karen A. Gibbs, PT, PhD, DPT; Daryl Lawson PT, DSc; Susan Zhang PT; Amy Pearson, MA, PT, CWS; Anne Gallentine, Physical Therapist, Certified Wound Specialist; Carmen Liebelt, PT, DPT, MBA, WCC, DWC; Lisa Cabral Physical Therapist, Certified Wound Specialist, Certified Lymphedema Therapist; Karen Gainer, JD; Kate McKenney, PT, CWS; Lori Thorp, PT, MS, MBA; Sheila Dolan, PT WCC; Tricia Kelly BSN, RN, WCC, OMS; Andrea Lightfoot BSN, RN WOCN; Kari Gabehart WCC FNP-BC; Lisa Haggitt DPT, CCS; Christina Fields, PT, MPT, CCS; and William Farr, PT MPT OMPT

I am writing in response to the request for comments on the Wisconsin Physician Services Insurance Corporation’s (WPS) draft Local Coverage Determination (LCD): Wound Care (DL37228).

I am a physical therapist practicing in a rural setting where I evaluate and treat patients of all ages with a wide array of conditions and diagnoses including patients with various wounds. I see patients as outpatients, inpatients (acute, observation, swing bed), and on home health. My coworker, who specializes in wound care, sees mainly all of the patients with wounds. She has patients traveling from various surrounding towns/cities due to her excellent care and treatment results and has been able to provide a valuable service to this area.

As a physical therapist and AVP of therapy services, I appreciate the opportunity to provide feedback to WPS on the proposed LCD. While I appreciate WPS’ recognition of the valuable role of physical therapists in the delivery of wound care, I take issue with several provisions included within the proposed LCD.

Wound Care: (DL37228)

I urge WPS to modify the draft LCD in accordance with the recommendations put forth in my detailed comments below.

Recommendation 1: Do not require a physician order for therapy/wound care services.

Physical therapists are authorized to deliver physical therapy services without an order or referral under state law; as such, the physician order requirement is not consistent with contemporary physical therapist practice. Every state, the District of Columbia, and the US Virgin Islands (USVI) have recognized the safety and benefits of direct access to physical therapy by removing from their statutes all or some of the referral requirements or order provisions for evaluation and treatment by physical therapists. In all of these states, physical therapists are “self-referring” or “ordering” and are furnishing services to their patients with limited or no restrictions. Specifically, in 20 states, laws are silent on the need for an order or referral, indicating there are no restrictions or limitations on accessing physical therapist services; in 27 states, the District of Columbia, and the USVI, individuals have access to a physical therapist’s evaluation and treatment with varying limitations, such as a time or visit limit, or a referral requirement for a specific treatment intervention; and in 3 states, patients have more limited access to physical therapist services—
for instance, physical therapist services may be restricted to patients with a previous medical diagnosis or who are subjects of a previous physician referral.

Further, pursuant to Medicare Benefit Policy Manual, Chapter 15 Section 220.1.1, “there is no Medicare requirement for an order.”

Moreover, wound care is within a physical therapist’s scope of practice. Acting within their scope of practice, physical therapists perform sharp debridement of devitalized tissue in addition to other wound healing procedures, such as pulsed lavage with suction; electrical stimulation; high-frequency ultrasound; contact and noncontact low-frequency ultrasound; monochromatic infrared energy; laser; negative pressure wound therapy; ultraviolet light therapy; Unna boot application; short-stretch bandaging; multilayer compression bandaging; contact casting; and lymphatic drainage techniques. Pursuant to the American Physical Therapy Association’s (APTA) Guide to Physical Therapist Practice, the physical therapist provides “application of therapeutic methods and techniques to enhance wound perfusion and establish an optimal environment for wound healing by any of the following mechanisms: facilitation of cellular changes needed for wound healing, removal of nonviable tissue, removal of wound exudate, elimination of peripheral edema, and management of scar tissue. Methods and techniques may include debridement, dressing selection, orthotic selection, protective and supportive device recommendations and modifications, biophysical agents, and topical agents.”¹

No state practice act prohibits physical therapists from practicing wound management. Nine state practice acts specifically state that “integumentary protection and repair” interventions are within the physical therapist’s scope of practice, and seven indicate that “wound care” is within the physical therapist’s scope of practice. In states that do not mention specific wound management interventions, physical therapists are allowed to perform wound/integumentary interventions as described in the Guide to Physical Therapist Practice. Additionally, no state practice act prohibits physical therapists from performing debridement, and, in fact, 20 state practice acts specifically indicate that debridement is within the physical therapist’s scope of practice.

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¹Guide to Physical Therapist Practice. 2014. Chapter 37: Integumentary Repair and Protection Techniques. American Physical Therapy Association. http://guidetoptpractice.apta.org/content/1/ SEC37.body?sid=10df2c43-070f-4c07-ac70-f548437b0e1a

Physical therapists can provide evaluation and treatment therapy/wound care services without the need for an order or referral from any other health care professional in accordance with state law (or where allowed by state law). Therefore, I strongly recommend that WPS modify the LCD to eliminate the physician order requirement for therapy/wound care when furnished by a physical therapist.

Recommendation 2: Do not require a plan of treatment to be signed before treatment.

Physical therapists enter the profession with a Doctor of Physical Therapy (DPT) degree, as all currently accredited physical therapist education programs offer a DPT only.² Physical therapists’ entry-level education uniquely prepares them in wound management. In fact, the physical therapist’s in-depth knowledge and skill in movement science, body system screening, anatomy, and pathophysiology provide the perfect foundation for practitioner involvement in the early detection, direct wound management, and prevention of integumentary system compromise. Principles of range of motion, stretching and strengthening, gait training, positioning, and soft tissue mobilization, common in all entry-level programs, in addition to pulsed lavage, sound, electrical, and mechanical energies for wound cleansing, debridement, edema reduction and control, and tissue stimulation, are vital interventions in a comprehensive plan of care focused on wound closure and return to function. Additionally, appropriate use of active biophysical agents unique to physical therapist training and education can be equally important.

The education that physical therapists obtain in wound management is greater than for most disciplines that provide wound care, including physicians and nurses. There is significant wound-specific content included in APTA documents regarding integumentary content for physical therapist entry-level education: Minimum Skills³, Normative Model,⁴ and the Wound Management Guide⁵. Additionally, some advanced knowledge and skill topics are shown to give an idea of content obtained at the postgraduate (continuing education, mentoring, and work experience) level for specialized practice in wound management. A complete list of advanced knowledge and skill expectations required for board certification in wound management can be found on the American Board of Wound Management (ABWM) website⁶. Additionally, there is now a wound management specialty within the physical therapy profession, demonstrating physical therapists’ expertise in this area. The combined information of both entry-level and post-professional knowledge and skill clearly demonstrates the many ways in which the physical therapist can manage wound care comprehensively and contribute as a member of the wound care team.

²http://www.capteonline.org/uploadedFiles/CAPTEorg/State Boards/MasterListofAccreditedPTPrograms.pdf#search=%22DPT%22.
³Minimum Required Skills of Physical Therapist Graduates at Entry-Level. American Physical Therapy Association. http://www.apta.org/uploadedFiles/APTAorg/About Us/Policies/BOD/Education/MinReqSkillsPTGrad.pdf.
⁴American Physical Therapy Association. A Normative Model of Physical Therapy: Version 2007. https://iweb.apta.org/Purchase/ProductDetail.aspx?Product_code=E-47-07
⁵APTA’s academy on clinical electrophysiology and wound management guide for integumentary/wound management content in professional physical therapist education. 2014. American Physical Therapy Association. http://www.apta.org/uploadedFiles/APTAorg/Educators/Curriculum Resources/Section/GuideIntegWoundinEducation.pdf
⁶http://www.abwmcertified.org/abwm-certified/cws/cws-how-to-prepare

Pursuant to the Medicare Benefit Policy Manual, Chapter 15 Section 220.1.3(B), the Centers for Medicare and Medicaid Services (CMS) already requires that a physician (or nonphysician practitioner) certify the therapist’s plan of care within 30 days of the initial therapy treatment, albeit compliance with the physician signature requirement is a logistical and administrative burden on physical therapy providers and physicians, taking valuable time and resources away from delivering patient care. The physical therapist performs due diligence in seeking physician signature/approval of the plan of care; however, the financial burden falls on the physical therapist if a signature is not obtained. Accordingly, although an unintended consequence, care frequently is delayed while awaiting a physician signature—often after multiple requests—placing the beneficiary’s health at risk due to the delay. Potential detriment to the patient if physical therapist intervention is delayed includes infection, hospitalization, surgery, and death, all of which increase costs to both the Medicare Trust Fund and the Medicare beneficiary. There is absolutely no doubt that requiring physician signature prior to initiating a care plan would result in significantly longer delays in patient care and substantial increases in administrative burden.

Further, imposing new documentation requirements on physical therapists, without justification, directly contradicts CMS’ claim that its top priority is putting patients first under the “Patients over Paperwork” initiative—the agency’s own internal process to reduce unnecessary burden, increase efficiencies, and improve the beneficiary experience.

Additionally, imposing such a requirement adds no meaningful oversight to that which is already present, as physical therapists are already working collaboratively with the physician, and this policy would only serve to harm the collaborative partnership between the two providers. Physical
therapists’ involvement in a collaborative approach to wound care often reduces and even eliminates impediments to wound therapy. As outlined below, physical therapists play an integral and collaborative role in wound care in the acute, outpatient, and skilled nursing settings.

Acute. In acute care settings, physical therapists routinely provide treatment to patients with complicated burns, traumatic injuries, and postsurgical wounds. Additionally, many patients with acute illness and injury are susceptible to further insult from pressure and skin organ failure. Since payment in the acute care setting is based on diagnosis-related groups, it is important for patient care to be efficient and collaborative in nature. In this setting, physical therapists contribute to the wound management team by provision of risk assessment, functional mobility training, direct management of open wounds, positioning, pressure redistribution, exercise, and application of biophysical agents for pain reduction and tissue healing, patient and caregiver education, and disposition of care once discharged from the acute care setting.
Outpatient. In outpatient settings, patients may be more medically stable but can present with complex open wounds. In this setting, physical therapists might utilize wound management techniques such as debridement, compression, total contact casting, and the application of biophysical technologies including negative pressure, pulsed lavage, and electrical stimulation. Incorporation of therapeutic exercise into the wound management plan is also important as is maximizing functional movement. While the focus on function is not specific to outpatient, improving mobility and independence frequently is a primary goal in this setting as many patients wish to return to work, family, and social obligations, and have a positive quality of life.

Skilled Nursing. Patients in the skilled nursing setting often are frail, typically not medically stable, have little independent mobility, and may have extensive wound care needs complicated by multiple comorbidities that significantly reduce healing potential. For these reasons, the team approach to wound management is especially important in skilled nursing. In this setting, the physical therapist’s role focuses not only on physical rehabilitation and pressure risk assessment/intervention, but also may have a strong emphasis on examination and evaluation of the entire patient. Screening and monitoring techniques are important, since specialty physicians typically are available only on a monthly basis (if at all) in this setting, placing a stronger responsibility on physical therapists to track changes in patient status. The physical therapist also may be the primary provider of sharp debridement for patients with open wounds.

It is nonsensical to require the physician to sign the plan of treatment prior to treatment. Therefore, because the administrative burden of this regulation is already untenable, the proposed LCD language is inconsistent with CMS policy, and adopting this requirement would result in significant delays to care, with adverse physical harm to the patient, I strongly recommend that WPS not require the plan of treatment to be signed prior to treatment.

Recommendation 3: Revise the weekly progress note requirement to align it with the Medicare Benefit Policy Manual Chapter 15.

CMS does not require physical therapists to complete a weekly progress note. Pursuant to Medicare Benefit Policy Manual Chapter 15, Section 220.3(D), the progress report provides justification for the medical necessity of treatment. The minimum progress report period shall be at least once every 10 treatment days. Moreover, there already exist significant requirements for documentation to support the billing. Per Medicare Benefit Policy Manual Chapter 15, Section 220.3(E), documentation must include “identification of each specific intervention/modality provided and billed, for both timed and untimed codes, in language that can be compared with the billing on the claim to verify correct coding...”

In addition, it appears that WPS has ignored the fact that many beneficiaries are seen on a less frequent basis than once per week. Thus, requiring providers to document each week that the patient was not
treated only serves to further invoke provider frustration, stress, and administrative burden, doing nothing to contribute to the delivery of high-quality, cost-effective care. For these reasons, I strongly recommend that WPS modify the progress note requirement to align with current CMS policy, which is that the progress report shall be completed at least once every 10 treatment days.

Conclusion

I thank WPS for the opportunity to comment on the Draft LCD L37228: Wound Care. I stand ready to work with WPS to identify a solution that will safeguard the financial health of the Medicare program while ensuring that beneficiaries have adequate access to high-quality wound care services. Thank you for your consideration.

Please see the following references: IOM 100.02 Medicare Benefit Policy Manual, Chapter 15 , Section 220.1.3 Certification and Recertification of Need for Treatment and Therapy Plan of Care is the physician’s/non-physician practitioner’s (NPP) approval of the plan of care. Certification requires a dated signature on the plan of care or some other document that indicates approval of the plan of care. Outpatient therapy services furnished to a beneficiary by a provider or supplier are payable only when furnished in accordance with certain conditions. The following conditions apply: A plan for furnishing such services has been established by a physician/NPP or by the therapist providing such services and is periodically reviewed by a physician/NPP* (see 42CFR424.24(c), §220.1.2);

• Services are or were furnished while the individual is or was under the care of a physician It is appropriate that treatment begins when a plan is established.

Initial Certification of Plan: should obtain certification as soon as possible after the plan of care is established, unless the requirements of delayed certification are met. “As soon as possible” means that the physician/NPP shall certify the initial plan as soon as it is obtained, or within 30 days of the initial therapy treatment

CMS guidance is clear per the Medicare Benefit Policy Manual that physician/NPP be an integral part of the care plan. A certification is required and it requires a dated signature of the physician/NPP. Therefore, WPS rejects the request to eliminate need for a physician order entirely. CMS guidance states the therapist may develop the plan and must obtain initial certification "as soon as possible." This does not imply the certification be obtained prior to treatment. WPS continues to feel an order is needed from a physician/NPP for the services. Although the entire care plan is not needed, there should be a physician order prior to the initiation of the services. The care plan can then be developed by the therapist, implemented and signed "as soon as possible" then by the physician/NPP. Please see the final article for changes in the language to reflect this more clearly.

I am a Podiatrist who is passionate about saving limbs and saving lives. Patients with diabetes/high risk comorbidities will inevitably suffer with wounds on their lower extremities and will need wound care/debridement/management at some point in their lives. This takes special health care team members such as but not limited to Cardiovascular surgery, Vascular surgery, Infectious Disease, Podiatry, Physical Therapists, Nurses, and Social Workers. Patients who do not receive proper care are at risk of losing not just their lower extremity but also their life.

Just ask yourself one question: would you want your leg amputated if you had a wound?

I believe every one of us would say no. Then please do not pass the LCD DL37228 as you are denying excellent and paramount healthcare for those individuals faced with limb loss.

Thank you for your time,     Seung-Jae Song, DPM

Thank you for the comments. Please see Response Number 6.

My name is Kara Gainer and I am the Director of Regulatory Affairs for the American Physical Therapy Association. Over the last several days, I have been alerted by several APTA members who have attempted to submit comments on DL37228: Wound Care that their comments are not being accepted.

These individuals are sending their comments in an attachment to this email address, but are receiving the response: WPS is unable to accept links due to our security guidelines. Please provide the information in an attachment so we may be able to review your supporting literature appropriately.

From the forwarded emails I have received from our members, it appears that WPS’ email system is flagging external emails and sending a warning: DO NOT CLICK links or open attachments unless you recognize the sender and know the content is safe. However, these are valid comments from individual clinicians that are being sent as an attachment, not a link. Is there another way you would suggest our clinicians submit their comments? For example, should they not submit the comments as an attachment, and instead embed the comments into the body of the email? Or is WPS able to modify its email settings to ensure these emails with attachments are coming through?

We want to ensure all of our members’ comments are being taken into consideration.    Kara R. Gainer, JD

Due to WPS security, encrypted messages or links are unable to be reviewed. Inquirer notified of proper protocols.

This is a very serious policy that you are considering. Do you realize it’s implications? Have you spent any time in an office that regularly sees wounds on the foot or any other part of the body? Do you understand what you are about to do and the profound effect you are going to have on patient care and the increased burden on the healthcare system including increased expense with the implementation of this policy?

I would invite any policymaker to a podiatrist‘s office. We see wounds on a daily basis that, if not caught early enough, would lead to amputation. Many look innocuous but underneath is a volcano about to erupt.

With the implementation of this policy, amputations rates will rise, healthcare expenses will rise and most importantly, patient care will be compromised. It saddens me when policymakers who know nothing about what they are deciding put patients at increased risk.

Please, visit a podiatrists’ office and see what you are voting on and do not allow this proposal to pass.
Walter G. Warren, DPM, CPed Indiana Podiatry Group

Please see Response Number 6 and the final changes to the LCD and Billing and Coding Article.

Encrypted message from Jared Overman

Due to WPS security, encrypted messages or links are unable to be reviewed. Inquirer notified of proper protocols.

As a Podiatric physician, residency trained, with more than. 27 years’ experience, please understand deride meant of ulcers is very important and a standard of care as wound exudate and hypertrophic skin. At wound edges needs to be debrided sharply to aid healing as these things serve to inhibit it , guaranteed. These are services we must be reimbursed for as Obamacare has hurt providers badly already and we need to make a living too.               James Lewandowski , Grand Island, NE

WPS agrees with the importance of debridement for wound healing. Please see the changes made to the final LCD and Billing and Coding Article.

I am the sole on call podiatrist at a critical access hospital in rural California. I care for many underserved patients with diabetic, vascular, and pressure ulcers. The proposed change to the LCD code is ridiculous. Ulcer debridement prevents amputation. Hospital admit and surgery is far more expensive than an office visit. Please reconsider this poorly thought out proposal.          George Rivello DPM AACFAS

WPS agrees diabetic wound care is important and debridement may be needed and warranted. Please see changes made to the final LCD.

Your proposed change in LCD cannot possibly have gotten approved by any medical person involved in wound care. To not debride any diabetic ulcer is to guarantee increased morbidity and complications. Wounds don’t heal if they are contaminated with necrotic debris or slough. Such material is just a breeding ground for bacteria. The literature is clear on this. Not only that, but diabetic ulcers have phenotypically abnormal tissue in the area, resulting in prolific callus formation rather than good epithelial migration. The best way to address this is to aggressively remove callus. This proposed policy is bad from the get-go.

As for grade II pressure ulcers, that’s a no brainer. Any PU that gets debrided is by definition grade III or higher. So this proposal is really just a clarification to practitioners to learn proper documentation. No objections to this part. Kenneth Newman M.D.

WPS agrees. The intent of the LCD was not to exclude debridement of DFUs. They have had coverage under neuroischemic wounds. Please see the final changes to the LCD and Billing and Coding Article for further clarification.

Re:draft local coverage determination (LCD) DL37228, which states:

1. Debridement for diabetic foot ulcers is not necessary and not covered
2. Debridement for stage II pressure ulcers is not necessary and not covered
3. Debridement of ANY ulcer not deeper than the layer of skin is not necessary and not covered.
I disagree with the statements 1-3. They are not always true and if there is no treatment and evaluation of Stage I and II severe complications will ensue requiring hospitalizations, surgery, and ultimately amputation. This would be a terrible policy to implement. Simon Young, DPM

Comments reviewed. Please see the final changes to the LCD and Billing and Coding Article.

As follow up from the WPS open meeting 10/21/2019 specifically relating to the wound care discussions, attached are the clinical practice guidelines that Dr. Noel requested I submit for their inclusion at upcoming CAC meetings.  Jule Crider , Executive Director AAWCM

The following documents were submitted as attachments: 2012 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections; Part of the 2019 IWGDF Guidelines on the Prevention and Management of Diabetic Foot Disease; Wound Repair and Regeneration: Guidelines for the treatment of diabetic ulcers; The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine

IDSA guidelines state debridement aimed at removing debris, eschar and surrounding callus has moderate to strong evidence. IWGDF guidelines state 1. Remove slough, necrotic tissue and surrounding callus of a diabetic foot ulcer with severe ischemia into account. (GRADE Strength of recommendation: Strong; Quality of evidence Low) The European Wound Management Association (EWMA) states that the emphasis in wound care for DFUs should be on radical and repeated debridement. Guideline for the treatment of DFU: Guideline #3.1: Remove all necrotic or devitalized tissue by surgical, enzymatic, mechanical, biological, or autolytic debridement. (Level II; detailed discussion of debridement is in Wound Preparation Guidelines.) A clinical practicee guideline (SVS, APMA, SVM): Recommendation 4: Considering lack of evidence for superiority of any given debridement technique, we suggest initial sharp debridement with subsequent choice of debridement method based on clinical context, availability of expertise and supplies, patient tolerance and preference, and cost-effectiveness (Grade 2C).Based on the reviewed documentation and guidelines DFU should be debrided when necessary. Although this was already covered under neuroischemic ulcerations, WPS agrees it is necessary to specifically reference DFU as an entity for debridement coverage. Please see the final LCD changes.

The proposed change to the LCD removing diabetic foot ulceration as a covered benefit is dangerous. These patients are often sick with multiple co-morbidities. Amputation rates if you take away dfu debridement will increase dramatically. This will result in increased unnecessary hospitalizations, and loss of limbs. Losing a limb in a diabetic patient has terrible mortality rates associated with as well as increased risk for loss of contra-lateral limb. This decision if approved will prove catastrophic for many of my diabetic patients. Pleas, I urge you, do not remove debridement of dfu from the LCD. Heidi Monaghan, DPM, FACFAS, CWS-P

WPS did not and does not have the intent to remove treatment for DFU. Debridement was covered under neuroischemic ulcerations. See final LCD for changes.

I would like to thank Dr. Holzmacher and the other WPS medical directors and administrative staff for the opportunity to comment on the WPS Wound Care LCD.

As you know our concern is that since the issuance of LCD L37228 on Wound Care, effective April 2018, WPS no longer provides coverage of debridement specifically for Stage II pressure ulcers, diabetic foot ulcers without neuropathy or neuroischemia, and chronic non-pressure ulcers with a tissue severity of “limited to breakdown of skin.”

WPS’ policies are inconsistent with the established standard of care for the treatment of wounds – the universally and widely accepted best practice for any wound exhibiting devitalized tissue is to debride that wound – regardless of the type of wound or its cause. The standard of care for the treatment of wounds has always included debridement of devitalized tissue ie. Necrotic tissue, slough, debris, abnormal granulation tissue and infected tissue. This devitalized tissue when present has been shown to harbor bacteria and to inhibit wound healing. The standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is based on the condition of the wound itself regardless of what medical conditions the patient has.

Additionally, WPS wound policy now sharply contrasts the policies of the majority of its MAC counterparts. Of the seven other MACs, five have LCDs that cover debridement, and while all have requirements for coverage, none limits ulcer types, other than WPS. WPS wound care policy now also sharply contrasts CMS policies that address standards of wound care. One example is the NCD for Hyperbaric Oxygen Therapy contained on the Internet-Only Manual. The CMS hyperbaric oxygen policy includes “diabetic wounds of the lower extremities” as a qualifying condition providing the “patient has failed an adequate course of standard wound therapy”. CMS further states in the policy that “standard wound care in patients with diabetic wounds includes”: “debridement by any means to remove devitalized tissue and maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings”.

WPS wound policy also ignores recommendations of the National Pressure Ulcer Advisory Panel (NPUAP). Their recommendations state– “there is strong informed clinical consensus to support the role of debridement in wound bed preparation, despite the ethically understandable lack of randomized controlled trials directly comparing debridement to no debridement in human subjects”

The concept of wound bed preparation has been around for over 3 decades. Studies have shown support for “TIME” (Tissue debridement, Infection control, Moisture balance and Epithelial or Edge advancement). The TIME framework consists of comprehensive strategies that can be applied to the management of different types of wounds to maximize the potential for wound healing. It promotes principles of wound bed preparation, including that debridement is necessary to restore the wound base in cases where the tissue is non-viable or deficient. The TIME model is taught in allopathic and osteopathic medical school curriculum as well as podiatric medical schools (Temple University School of Podiatric Medicine).

There is broad clinical consensus regarding the need for and benefit of debridement to remove devitalized tissue in order to improve visualization of the wound, remove necrotic tissue or foreign bodies, reduce bacterial load, prepare the wound bed, and stimulate healing. We see this in guidelines issued separately by the Wound Healing Society, the International Working Group on the Diabetic Foot, and the NPUAP, in addition to cross-society guidelines issued by APMA in collaboration with counterparts focused on vascular medicine and surgery. Peer reviewed clinical decision support tools like UpToDate also call for the removal of devitalized or necrotic tissue for proper wound care.

For example - the Wound Healing Society provides updated guidelines for treating diabetic foot ulcers

Guideline 3.1 - directs providers to remove all necrotic tissue by surgical, enzymatic, mechanical, biological or autolytic debridement;
Guideline 4.2 – states, initial debridement is required to remove the obvious necrotic tissue, excessive bacterial burden, and cellular burden of dead and senescent cells. Maintenance debridement is needed to maintain the appearance and readiness of the wound bed for healing.

Another example is The International Working Group on the Diabetic Foot has addressed treatment of chronic diabetic foot ulcers, noting that the majority of national guidelines emphasize that debridement is essential to good wound care.

In looking at the various research and clinical practice guidelines that WPS used to support its position it seems that WPS selectively pulled out statements that supported their position but made no mention of the other statements and conclusions that did not support their position. One example is the Management of the Diabetic Foot, A Clinical Practice Guideline by the Society for Vascular Surgery in Collaboration with the APMA and the Society for Vascular Medicine. This paper does not divide diabetic ulcers into groups based on depth or neuropathy or PAD. But rather it refers to diabetic ulcers as a whole and states that the patient demographics related to diabetic foot ulceration are typically for patients with long standing diabetes. Risk factors for ulceration include neuropathy, PAD, deformity, limited ankle ROM, high plantar foot pressures, minor trauma, previous ulceration or amputation and visual impairment. When WPS selectively chooses neuropathic ulcers and neuroischemic ulcers it ignores the other risk factors making up the other 10-15 % of diabetic ulcers ie. Those with other risk factors such as deformity, ankle equinus, high plantar pressure etc.

Conclusion

Prohibiting coverage for these types of ulcers places patients at risk for worse outcomes, and places providers in the position of having to choose between providing care that is inconsistent with their medical training, clinical guidelines, and the standard of care or foregoing reimbursement for medically necessary care that vulnerable patients need. Prohibiting coverage of standard wound care for these wounds can also jeopardize the patient’s ability to qualify for other advanced treatments such as grafts and HBO based on CMS policies.

APMA and IPMS strongly urges WPS to reconsider and revise the proposed LCD and finalize updates that would provide for coverage of debridement services for stage II pressure ulcers, diabetic foot ulcers without neuropathy or neuroischemia, and chronic non-pressure ulcers with “severity limited to breakdown of skin” when devitalized tissue is present.

Patrick is a 70 y/o male who is a long-time patient of mine. Patrick has type II diabetes and his last HgA1c was 7.9. Patrick travels to his job at the Salvation Army and to my office via the city bus system. He has the misfortune of having a pair of pancakes for feet with severe bunion deformities and hammer toe deformities. He wears diabetic accommodative shoes and inserts which are a covered benefit from Medicare.

Patrick periodically presents to my office with blisters, abscesses or fully ulcerated wounds at his callus sites or at his bony deformities. I treat these occasional wounds with the standard for wound care which includes initial debridement and subsequent debridement as required.

WPS has now placed me in the position of foregoing standard wound care or providing wound debridement without being able to bill or receive reimbursement. David W. Schroeder, DPM, FACFAS

This comment is well thought out and cites numerous articles and policy positions that support the addition of DFU beyond just neuroischemic ulceration for coverage. The comments also address the other stages of wound healing and whether those should be covered. The comments make a good argument for the benefit of debridement to pressure ulcers of limited skin breakdown. Based on this comment and the cited references WPS has made several changes to the final LCD. Refer to the final LCD for further clarification.

Please do NOT consider LCD DL 37228. By ignoring early ulcer stages, we will all be paying for increased late stage complications like infection gangrene and amputation.      P. Zimmerman, DPM

Comment reviewed. It does not address the specific wounds in the reconsideration.

I am a foot and ankle specialist/podiatrist, practicing in Pennsylvania. I heard about the proposed changes to above LCD, deeming a foot and ankle wound debridement not a medically necessary procedure. It is likely easy to make those statements when you are not on the front line and treat this patients every day of your life, to see how we save their limbs, and educate them through every visit in our office. Diabetic patients are losing their limbs even from something as small as a blister on their toe caused by tight shoes, trauma, burn, leave alone pressure wounds, add on the picture also ESRD and then we can have a lengthier talk about this issue.

Before proposing certain policies changes, isn't appropriate to visit the doctor's office and see how such procedures affect outcome of the wound or limb salvage?

It is easy to talk from your position if this is not affecting you, your foot, you parent or loved ones, put yourself in this patient's shoes and then we can talk. I care about mg patients like I care about my family members, this is what sets myself and many more physicians of my specialty aside. Look at statistics and see rate of limbs saved from regular surgical debridement, whether in the office and OR and then we can discuss the issue further.

What am I going to tell my patient's when I see a wound that has a lot of slough, it is getting worst and deeper? I cannot touch it, per your insurance decision not to deem this medically necessary. Or how am I going to hold in a trial from lawsuit from patient losing his/her limb, have you and your policy dragged into it?

Please think this thoroughly and implications associated with it and then decide.        Bruni Leka, DPM

WPS policy has not been nor will be to limit treatment of DFU.

I am trying to address this ludicrous proposal in a sane way. Who in the world thought that declaring debridement of diabetic wounds, pressure wounds and dermal wounds not medically necessary was a judicious and prudent decision? Clearly, the ignorant fool(s) that have made this proposal has as much clinical experience as my 2nd grader. These wounds will NEVER heal without proper wound care- debridement is the cornerstone of wound care. The removal of nonviable tissues through selective and thorough sharp debridement is vital for successful healing, prevention of further infectious processes and preservation of limb function and salvage. The idiocy of declaring these debridement’s as not medically necessary is harmful to hundreds of thousands of patients. If this proposal passes, the persons responsible for suggesting and passing this uneducated and nonsensical proposal will be morally responsible for the increased loss of limbs and lives we are certain to witness.

This proposal must not pass.      Michelle Hinze, DPM FACFAS

Thank you for your submitted comments. Comment reviewed. It does not address the specific wounds in the reconsideration.

I am writing about the above proposed LCD 10 that states debridement is not necessary and not covered. This could not be further from the truth. Debridement is a crucial tool to facilitate wound healing and preventing the Morbidity and Mortality associated with wounds including but not limited to amputation sepsis and death. Without this tool we can expect an increased burden on our health systems.
Maureen Clinchms1 DPM

WPS policy has not been nor will be to diminish the importance of debridement. The reconsideration request was debridement for certain types of wounds. The comment appears to refer to all wounds, which is not under reconsideration and not at all the implications of the draft LCD.

The determination that diabetic ulcer debridement and debridement of stage II ulcers in the proposed LCD being not medically necessary is not true. Devitalized infected tissue can occur at any level of ulceration and good wound care dictates debridement of such tissue to prevent non-healing and infection leading to hospitalization and amputation.                    Melissa Gaffney, DPM

WPS agrees with the comment after review of comments and additional literature. Please see the final LCD, Billing and Coding Article.

In regards to the proposed LCD DL37228 for determining that debridement of a diabetic foot ulcer is not medically necessary is absolutely untrue and would be a disservice to patients with these conditions. There are several reasons why debridement is necessary including converting a stagnant non-healing chronic wound with visible scar tissue into an acute wound which is more likely to heal as well as removing bioburden, and removing excess necrotic nonviable tissue that is impeding cell migration and growth factors from entering the surface of the wound.

I challenge anyone who would say otherwise to read basic text and wound healing and how important debridement is especially for diabetic foot ulcers. David A. Kretch, DPM

WPS agrees with the comment after review of comments and additional literature. Please see the final LCD.

Serial debridement of any foot ulcer is the standard of care in any medical field. Debridement is medically necessary. There are multiple scientific articles to support this. By not covering this service, patients will be at increased risk for infection and amputation. Consider your own health in this matter. Would you want a service covered by insurance that helps one heal a foot ulcer, prevent infection/amputation?           Alex Craig D.P.M.

WPS agrees with the comment after review of comments and additional literature. Please see the final LCD.

I reviewed the letter and in principle the debridement is needed of all necrotic tissue for the stated purposes. Whether the ulcer is diabetic or otherwise, debridement when necrotic tissue is present is needed to stimulate healing. I feel that debridement, if done appropriately should not be repeated and charged for repeatedly. Perhaps allowing a debridement code for the diabetic and other ulcers should have at least a 30 days global.
Edmond B. Cabbabe, M.D., FACS

WPS agrees with the comments regarding debridement and the suggestion is noted.

In regards to the proposed LCD coverage through DL37228, may I suggest that you consult medical professionals in regards to the positive effects of wound debridement, regardless of wound stage. There is ample research stating that preventative care is medically necessary, appropriate, and in the patient’s best interest. Removing debridement as a medically necessary covered item will result in far more patient amputations, physical therapy appointments, corrective orthoses, corrective shoe/toe box fillers, disability claims, lower quality of life for the patient, etc. I urge any and all proponents of this measure to carefully consider the research and the medical necessity of wound debridement.                   Jennifer Larson, Office Manager

WPS policy has not been nor will be to diminish the importance of debridement. The reconsideration request was debridement for certain types of wounds. The comment appears to refer to all wounds, which is not under reconsideration and not at all the implications of the draft LCD.

I am writing to express my concern about the potential debridement of diabetic foot ulcers not being necessary and therefore not covered. Not only is it my medical opinion that this treatment reduces the morbidity of my patients, this is also widely supported with years of medical literature and studies. Not paying for this would be short sight and would surely lead to costly hospitalization and surgeries.                  Binh Nguyen, DPM

WPS agrees with the comments. See the final LCD and Billing and Coding Article for clarification.

The debridement of diabetic ulcers is vital to the care of this patient population and is medically necessary for the prevention of amputation, and loss of life.

I see diabetic patients in the emergency department every day that have had neglected partial thickness ulcers which have gone on to fill thickness ulcers leading to infection, sepsis, requirements for amputation, long hospital stays, and death. This leads to a tremendous expense to the healthcare system and insurance companies.

Treatment of these wounds early and aggressively with close follow up and repeated debridement is key to preventing much more expensive costs. These patients are neuropathic and have lost the "gift of pain." They will continue to walk on these wounds until they develop and lead to an abscess or a blood or bone infection.

Neglecting these patients is as dangerous of not covering prostate or breast cancer screenings, vaccines, or any other preventative treatment. Except in these cases, the course of disease can move quickly and unpredictably if no intervention is taken.

These patients are common, they are difficult to care for, and they are expensive, but if you refuse to cover the early interventions which are necessary to prevent the dangerous and expensive progression of these wounds, you are literally cutting off the feet of the diabetic community.
Adam Port DPM

WPS agrees with the comments. See the final LCD and Billing and Coding Article for clarification.

In the purposed Wound Care LCD DL37228 it states that in order to debride a wound:

“At least ONE of the following conditions must be present and documented:
Pressure Ulcer, Stage 3 or 4
Venous or Arterial insufficiency ulcers
Dehiscenced wounds
Wounds with exposed hardware or bone
Neuropathic ulcers neuroischaemic ulcers
Complications of surgically created or traumatic wounds were accelerated granulation therapy is necessary which cannot be achieved by other available topical wound treatment”

Comment:

I formally request that Diabetic foot ulcers be added to this list found in DL37228.

Rational:

Roughly 9.4 percent (100 million) of Americans have diabetes. (Source: https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html). Of those Americans with Diabetes it is estimated that 19-34% of them will experience a diabetic foot ulcer in their life time. (Source: https://www.podimetrics.com/publications/Armstrong% 202017%20Diabetic%20Foot%20Ulcers%20and%20their%20Recurrence.pdf). "Diabetic foot complications are the most common cause of nontraumatic lower extremity amputations in the industrialized world. The risk of lower extremity amputation is 15 to 46 times higher in diabetics than in persons who do not have diabetes mellitus." (Source: https://www.aafp.org/afp/1998/0315/p1325.html). The "direct costs of treating diabetic foot complications exceed the treatment costs for many common cancers. In the United States, a total of $176 billion is spent annually on direct costs for diabetes care; as much as one third of this expenditure is lower-extremity–related, constituting a substantial cost to society" (Source: https://www.podimetrics.com/publications/Armstrong% 202017%20Diabetic%20Foot%20Ulcers%20and%20their%20Recurrence.pdf). After a major amputation a diabetic has a 52-80% chance of death in the next 5 years following the amputation (Source: https://www.podiatrytoday.com/ closer-look-mortality-after-lower-extremity-amputation).

All of this can could be averted by following standard wound care; to include debridement (source: https://www.podimetrics.com/publications/Armstrong %202017%20Diabetic%20Foot%20Ulcers%20and%20their%20Recurrence.pdf).

Evidence has shown that debridement of diabetic foot ulcers enhances the healing process when combined with standard wound care for a diabetic foot ulcer.
(Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3282596/)

I understand that “neuropathic ulcers” are listed however this does not fall under a characteristic of all diabetic ulcers. Only roughly 85 percent of DFU’s are neuropathic (Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3282596/).                   Nick Jagodzinski RN, BSPH, WCC, OMS, DAPWCA

Well constructed date driven comment. WPS agrees. See the final LCD and Billing and Coding Article for coverage determination.

This is a comment on proposed policy “DL37228".

Frequent wound debridement is essential to healing diabetic wounds.

The number of debridements required for healing the wound varies from patient to patient depending on their co morbid conditions and on their response to treatment.

Failure to provide adequate wound care and failure to cover the medical treatments for appropriate wound care will lead to progression of the wounds , increased amputation rates , increased infection rates ( with associated increased cost of treating these infections) and an increase in the sepsis episodes with their associated comorbidities which may include death.

This proposed policy should be reconsidered.          Mihaela Ionescu, MD, FACP

WPS agrees with the comments. See the final LCD and Billing and Coding Article for clarification.

Please see my below comments regarding the proposed LCD DL37228:

The LCD states
No study was presented to show clear evidence that debridement improves ulcer healing.
If this mentality is used to direct the LCD, then there will be significantly more amputations, costs, morbidity and mortality. Debridement of nonviable material from ulcers is the most fundamental, evidence based clinical practices and most surely improves ulcer healing.              Troy Harris, DPM

WPS policy has not been nor will be to diminish the importance of debridement. The reconsideration request was debridement for certain types of wounds. The comment appears to refer to all wounds, which is not under reconsideration and not at all the implications of the draft LCD.

Urging WPS to reconsider this policy change and really trying to understand where this evidence/data comes from. Decades of studies have shown that chronic wounds need to be activated and augmented to an acute state to transition from stunted healing. Debridement is obvious and necessary in the treatment algorithm.       Paras Parekh, DPM.

WPS policy has not been nor will be to diminish the importance of debridement. The reconsideration request was debridement for certain types of wounds. The comment appears to refer to all wounds, which is not under reconsideration and not at all the implications of the draft LCD.

A similar letter was sent by the following: Michigan Podiatric Medical Association; Nebraska Podiatric Medical Association; Indiana Podiatric Medical Association; Missouri Podiatric Medical Association: and Iowa Podiatric Medical Society:

The undersigned physicians from the state of Kansas and the Kansas Podiatric Medical Association are writing to express grave concern regarding the proposed local coverage determination (LCD) on wound care, DL37228. Under the proposed LCD, which responds to a reconsideration request submitted by the American Podiatric Medical Association (APMA), WPS continues to prohibit coverage of debridement specifically for stage II pressure ulcers, diabetic foot ulcers without neuropathy or neuroischaemia, and chronic non-pressure ulcers with a tissue severity of “limited to breakdown of skin.” We believe this policy is inconsistent with the standard of care for the treatment of chronic wounds and harmful to patients who require access to this first-line treatment for limb-threatening ulcers, and we therefore urge WPS to revise the proposed LCD and finalize updates that would provide for coverage of debridement services for the conditions and circumstances noted above.
As physicians who routinely treat patients presenting with ulcers with varying etiology and severity, we understand that ulcers that demonstrate any type of devitalization must be debrided to maintain a clean and moist wound bed to help prevent infection and promote healing. Such devitalization may occur in stage II pressure ulcers, diabetic foot ulcers without neuropathy or without neuroischaemia, or ulcers limited to breakdown of the skin. Rather than relying on the presence of devitalization as a clinical indicator, however, the proposed LCD focuses on the type or severity of the ulcer to determine whether debridement will be covered. We believe this approach is short-sighted, and fails to put patients and their health care needs first.
Debridement of wounds with devitalization is a standard of care that is broadly accepted and practiced by clinicians of numerous specialties – so much so that it was characterized as such in a Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD), without any linked citation.1 Specifically, this NCD states:
1 National Coverage Determination 270.1: Electrical Stimulation (ES) and Electromagnetic Therapy for the
Treatment of Wounds. Downloaded from https://www.cms.gov/medicare-coverage-database/details/ncddetails.
aspx?NCDId=131&ncdver=3&DocID=270.1 on November 28, 2018.

Standard wound care includes: optimization of nutritional status, debridement by any means to remove devitalized tissue (emphasis added), maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, and necessary treatment to resolve any infection that may be present.
While APMA submitted this NCD in its reconsideration request, the proposed LCD dismissively stated that this reference was “not relevant to the request.” We disagree. We find it wholly unfathomable that a national coverage determination may recognize a standard of care that has been established over time and through routine clinical practice, yet WPS cannot accept that standard of care when making a local coverage determination. Rather than recognizing how this statement reflects the larger picture of standard wound care and management, including debridement to remove devitalized tissue, WPS narrowly focused on whether the article addressed debridement for the types of ulcers specified in the reconsideration request. This narrow approach to review of the evidence does a disservice to chronic wound patients, given that the LCD only allows standard care to be provided once a wound increases in severity.
As APMA stated in its reconsideration request, the “absence of more recent findings reflects the broad and long-standing agreement in the field of wound care regarding reasonable and necessary care for early stage or low severity ulcers.” To be sure, the challenge in providing “evidence” to support a change in the LCD has been that few researchers have undertaken and published studies that contemplate the well-accepted standard of care for wounds that exhibit devitalization.
By prohibiting debridement for stage II ulcers, diabetic foot ulcers without neuropathy or neuroischaemia, and chronic non-pressure ulcers limited to breakdown of the skin, WPS is requiring that physicians practice in a manner that is inconsistent with their medical education1, 2 and the established standard of care3, 4, 5, 6, 7, 8, 9, 10, 11. This places physicians at risk for malpractice claims and extended litigation. More importantly, however, the proposed LCD increases the risk that patients experience progression in ulcer severity and other additional complications, potentially up to and including limb loss that may have been avoidable.
For these reasons, we urge WPS to revise the proposed LCD and finalize updates that would provide for coverage of debridement services for stage II pressure ulcers, diabetic foot ulcers without neuropathy or neuroischaemia, and chronic non-pressure ulcers with severity limited to breakdown of skin when devitalization is present.
Thank you for your consideration.

Kansas Podiatric Medical Association:

Jennifer Phillips, DPM and the following undersigned:

Warren W. Abbott, DPM  Heidi C Hagen, DPM  Scott Gordon, DPM
Ali Davis, DPM  Jon Morgan, DPM  Steve Sitek, DPM
Barry E. Wesselowski, DPM FACFAS  Joseph Svoboda, DPM  Steven Geduldig, DPM
Corin Wilde, DPM  Lawrence Gaston Jr. DPM  Thomas Boldry, DPM
David Blancho, DPM  Mark Edward Landry, DPM  Todd M. Van Wyngarden, DPM
David Laha, DPM, DPM  Michael Nachlas, DPM  Elsie Kreidler
Dr. Nicholas Posge, DPM  Richard Krause, DPM

Michigan Podiatric Medical Association: Derek Dalling,Executive Director

Jodie Sengstock, DPM and the undersigned:

Aaron Rives, DPM Gary Wasiak, DPM Michael L. Gerber, DPM
Ahmad Farah, DPM Guy Pupp, DPM Michael Munson, DPM
Alaa Mansour, DPM Harold Sterling, DPM Michelle Jupin, DPM
Alan Stiebel, DPM Harvey Lefkowitz, DPM Norman H. Brant, DPM
Alicia Ward, DPM Hatim T. Burhani, DPM Peter Gregory, DPM
Andrea Simons, DPM Howard D. Kane, DPM Rachel A Samsel-Militello, DPM
Andrew Mastay, DPM Howard Reznick, DPM Radu Dan Purtuc, DPM
Andrew Miller, DPM James E. Dewitt, DPM Randy K. Kaplan, DPM
Anthony Giordano, DPM Jay O. Meyer, DPM Randy Semma, DPM
Anthony Mollica, DPM Jeff Frederick, DPM Rauby Mohindroo, DPM
Arthur B. Kellert, DPM Jeff Mossel, DPM Razi Ahmed, DPM
Barry Sorkin, DPM Jeffrey B. Klein, DPM Rebecca Sundling, DPM
Barth Wolf, DPM Jeffrey Schwalb, DPM Robert Monfore, DPM
Benjamin Martin, DPM Jeffrey Stone, DPM Roger DeYoung, DPM
Brandon West, DPM
John Arsen, DPM Rory Cocks, DPM
Brent Van Til John D. Miller, DPM Sarah Stewart, DPM
Brett W. Butler, DPM John N. Evans, DPM Scott E. Byron, DPM
Brian G. Loder, DPM Joseph Silver, DPM Scott Hughes, DPM
Brian Goodwin, DPM Kathleen Bickle, DPM Shawn Reiser, DPM
Brian Goosen, DPM Kendall Tabor, DPM Sheryll Gildo, DPM
Brian M. Schmidt, DPM Kevan Kreitman, DPM Siraj Panchbhaiya, DPM
Bruce Jacob, DPM Kevin Garfield, DPM Stacy Uebele, DPM
Bruce Kaczander, DPM Kevin J. Piebenga, DPM Stefano M Militello
Bruce Meyers, DPM Khatija Ahmed, DPM Stephanie Carollo, DPM
Bryan West, DPM Kristi Ledbetter, DPM Steve Sheridan, DPM
Charles A. Borchard, DPM Lawrence Brown, DPM Tamara Marie Whitaker Bay, DPM
Charles M. Johnson, DPM Lawrence Rubin, DPM Tara Scott, DPM
Christopher Bussema, DPM Maninder Deswal, DPM Tara Stock, DPM
Craig J. Pilichowski, DPM Marc Borovoy, DPM Terry Federlein
Crystal Holmes, DPM Margaret Andrews, DPM Theodore Bens, DPM
David Mansky, DPM Marie Delewsky, DPM Tomasz Biernacki, DPM
David Moss, DPM Mark Squire Trevor Neal, DPM
Dean W. Singer, DPM Marshall Solomon, DPM Vaishnavi Bawa, DPM
Dennis Leveille, DPM FACFAS Mathew Pade Vicki Anton-Athens, DPM
Bruce Tabak, DPM Matthew K. Brown, DPM Viktoriya Barg, DPM
Steven Glickman, DPM Matthew Lappenga, DPM Walter Coleman DPM
Travis Piper, DPM Michael David, DPM William Stych, DPM
Edmund Kowalchick, DPM Michael G. Meyers, DPM Youssef Aoun, DPM
Elizabeth A. Horton, DPM Michael Holland, DPM Zeeshan Husain, DPM
Gary Kaplan, DPM Michael Kelley, DPM

Nebraska Podiatric Medical Association

Jon Goldsmith, DPM and the undersigned:

Alicia M. Ericksen, DPM Jordan Sikes, DPM Patrick Moore, DPM
Chad Summy, DPM Joshua Vest, DPM Robert Colligan, DPM
Charles M. Halverson, DPM Joshua Wray, DPM Robert Greenhagen, DPM
Clint Schafer, DPM Kara Krejci-Reed, DPM Scot Bandel, DPM
Derek Miller, DPM Mark Willats, DPM Shannon M. Lensing, DPM
Kevin Larsen, DPM Michael Powers, DPM Sylvia Trotter, DPM
Elizabeth Marie Klawitter, DPM Michael Zimmerman, DPM Torrey Rassfeld, DPM
Glenn P. York, DPM Michelle Hinze, DPM Wayne V. Videtich, DPM
James Whelan, DPM Nathan Penney, DPM Zackary Gangwer, DPM, FACFAS
Jason Bailey, DPM Nicholas Olari, DPM John Tennity, DPM
Patrick J. Nelson, DPM

Indiana Podiatric Medical Association Matt Solak, Executive Director

Wendy Winckelbach, DPM and the undersigned:

Aaron Warnock, DPM J. Karl Winckelbach, DPM Paul Sommer, DPM
Alex Kor, DPM James Meade, DPM Pratap Gohil, DPM
Alisha Kay Jones, DPM Jane Koch, DPM Richard A. Stanley, DPM
Amanda Vujovich, DPM Jason Woods, DPM Richard L. Isaacson, DPM
Andrew Rader, DPM Jeff Leibovitz, DPM Richard Loesch, DPM
Angie Glynn, DPM Jerwana Laster, DPM Romesh Dhaduk, DPM
Austin Muranaka, DPM Jesse Murphy, DPM Sandra Hudak, DPM
Brad Legge, DPM Jonathan Norton, DPM Sandra Raynor, DPM
Brandon Baker, DPM Jonathan Truchan, DPM Sarah Standish, DPM
Brandt Dodson, DPM Karl Fulkert, DPM Scott Neville, DPM
Brian Damitz, DPM Khawar Malik, DPM Scott Schulman, DPM
Cathy Coker, DPM Lisa Lanham, DPM Stella DeHeer
Charlotte Ann Reisinger, DPM Lorin Mickelsen, DPM Susan DeHeer
Chris Grandfield, DPM Marc Bruell, DPM Tarick Abdo, DPM
Christopher Winters, DPM Mark A. Lazar, DPM Thomas E. Freeman II, DPM
Corey Groh, DPM Michael Salcedo, DPM Timothy Howard, DPM
Cynthia Grundy, DPM, FACFAS MatthewParmenter,DPM, FACFAS,CWS Tod C. Huntley, MD
Damian Dieter, DPM Michael C. Lyons II, DPM Tod S. Reed, DPM
Daniel S. Miller, DPM Michael Carroll, DPM Tracy Warner, DPM
David F. Ray, DPM Michael Marasco, DPM Vincent. J. Coda. DPM
David Gurvis, DPM Michael S. Nirenberg, DPM Walter Warren, DPM, CPed
David Powell, DPM Mieasha Barksdale, DPM Wendy Goldstein, DPM
David Sullivan, DPM Miranda Goodale, DPM William Adams, DPM
Donald McGowan, DPM Natasha Mandula, DPM William K. Oliver, DPM
Elizabeth Vulanich, DPM Nathan Graves, DPM Zahid Ladha, DPM
Eugene S Pawlak, DPM Nick W. Jones
Francis Bean, DPM Patrick A. DeHeer, DPM
George Tsoutsouris, DPM Patrick Warner

Iowa Podiatric Medical Society

Kevin Kruse, JD, CAE
Dave Schroeder, DPM and the undersigned:

Alyssa Zacharjasz, DPM Howard Cox, DPM Mindi Dayton, DPM
Americo Lagone, DPM Inderjit Panesar, DPM Nathan Shumway, DPM
Benjamin J Willis, DPM Jana Poock, DPM Navin Gupta, DPM
Brian Hunziker, DPM Janice Gates, DPM Nicholas Schmerbach, DPM
Brian Rarick, DPM Jason Keppler, DPM Nicole Jedlicka, DPM
Charles Gilarski, DPM Jeffrey Olson, DPM Patrick Barnes, DPM
Charles Henty Allison, DPM Jill H. Scholz, DPM Patrick J. Weires, DPM
Christina Finken, DPM John F. Hamm, DPM Pauline Seymour, DPM
Christopher J. Considine, DPM John G. Erickson, DPM Philip J. Morreale, DPM
Chuck Cibula, DPM John Whitt, DPM Randy Joe Metzger, DPM
Collin Pehde, DPM Joseph Kukla, DPM Robert Caldwell, DPM
Dana Plew, DPM Joseph Newman, DPM Robert Eells, DPM
David Groen, DPM
Joshua Modlin, DPM Robert Kelsey, DPM
David Hemmes, DPM Julie Albrecht, DPM Robert Moratz, DPM
David Yount, DPM Kara Franzen, DPM Ronald D. Lee, DPM
John K. Hart, DPM Katherine Frush, DPM Ronald G. Cervetti, DPM
Steven E. Craig, DPM Kathie Whitt, DPM Ronald M. Kane, DPM
Edee Renier, DPM Kelsey Harvey, DPM Sara Oelke, DPM
Edward Prikaszczikow, DPM Kelsey Sukovaty, DPM Sean McMurray, DPM
Elizabeth Jacobsen, DPM Kevin Mulvey, DPM Stephen Solomon, DPM
Eric Jensen, DPM Kevin Smith, DPM Steven Ostiguy, DPM
Erin Ward, DPM Kimberly Harmon, DPM Tara Brock, DPM
Eugene Nassif, Jr, DPM Kirk Neustrom, DPM Theresa Hughes, DPM
Greg Valkosky, DPM Mark A Saathoff, DPM Tiffany Hauptman, DPM
Gregg Corrigan DPM Mark Beers, DPM Timothy Blankers, DPM
Gregory Lantz, DPM Mark Hartman, DPM Timothy Holcomb, DPM
Gregory McCarthy, DPM Marty J Kelley, DPM Timothy Joseph Quagliano, DPM
Gregory S. Duncan DPM Matthew C. McKnight, DPM Todd Dolphin, DPM
Hannah Johnk, DPM Michael Arnz, DPM Todd Miller, DPM
Heather L. Perry, DPM Michael Orosz, DPM W. Ashton Nickles, DPM

Missouri Podiatric Medical Association Steven Carroll, Executive Director

David Carron, DPM, President
Lindsay Barth, DPM, CAC Representative and the undersigned:

Akilis Theoharidis, DPM Seth Anderson, DPM Stephanie Jameson, DPM
John Holtzman, DPM David S. Carron, DPM Jared Visser, DPM
Richard Brandel, DPM Lincoln R. Nowlin, DPM Michael Lowhorn, DPM
Anthony Sikoutris, DPM Shari Kaminsky, DPM Terry Sanders, DPM
Joseph Drago, DPM Terrence G. Klamet, DPM Jeff L. Harsch, DPM, FACFAS
Richard Norlin, DPM Sharon Anderson, DPM Michael N. Fine, DPM
Arthur M. Weisman, DPM Edward Cline, DPM Thomas Kirisits, DPM
Karl Collins, DPM Louis Aquino, DPM Jeffrey Appleman, DPM
Robert R. Shemwell, DPM Sheldon Fleishman, DPM Mitch Dorris, DPM
Bob A. Shemwell, DPM Edward S Stein, DPM Timothy Oldani, DPM
Katherine Besselman, DPM Marianne Misiewicz , DPM Jeffrey S. Boberg, DPM
Russell Grimes, DPM Shelly Chadee Nancy Gasparovic, DPM
Brian Broadhead, DPM Geoffrey Bricker, DPM Veda Lewis-Simmons, DPM
Kathleen K. Appleman, DPM Matthew Nielsen, DPM Joel Foster, DPM
Ryan Frank, DPM Shelly Menne Patrick Anderson McShane, DPM
Christian Wunderlich, DPM Jacob Lamb, DPM Vincent L. Travisano, DPM
Kori H. Taylor, DPM Michael D. Weiss, DPM Radmila Samardzija, DPM
Samuel Wood, DPM Shelly Sedberry, MS, DPM Zachary Zobens, DPM
David Millward, DPM James D. Sills-Powell, DPM
Kurt W. Kaufman, DPM Michael Horwitz, DPM

The comments reiterate the concerns of the initial reconsideration request. Although WPS disagrees with some of the comments, particularly with focusing on that pertinent to the request, WPS has decided to make several changes to the final LCD. See the final LCD and Billing and Coding for clarification.

I am writing in response to the request for comments on the Wisconsin Physician Services Insurance Corporation’s (WPS) draft Local Coverage Determination (LCD): Wound Care (DL37228).

I am an occupational therapy supervisor of out-patient lymphedema services at Michigan Medicine. Our LE lymphedema patients are frequently scheduled and coordinated for treatment for lymphatic drainage following their PT wound care appointments. Working together in this manner ensures that the patient’s needs are being addressed in timely manner with delivery of standard of excellence in patient care.

I appreciate the opportunity to provide feedback to WPS on the proposed LCD. While I appreciate WPS’ recognition of the valuable role of physical therapists in the delivery of wound care, I take issue with several provisions included within the proposed LCD.                   Carole Dodge, OTRL, CHT

Comments appreciated but, not relevant to the reconsideration.

On behalf of our member physicians in the states serviced by Wisconsin Physicians Service Insurance Corporation (WPS), the American Podiatric Medical Association (APMA) and the WPS podiatric Carrier Advisory Committee (CAC) representatives write to express grave concern regarding the proposed Local Coverage Determination (LCD), “Wound Care”, DL37228. Under the proposed LCD, which responds to our reconsideration request, WPS continues to prohibit coverage of debridement specifically for stage II pressure ulcers, diabetic foot ulcers without neuropathy or neuroischaemia, and chronic non-pressure ulcers with a tissue severity of “limited to breakdown of skin.” We believe this policy is inconsistent with the standard of care for the treatment of chronic wounds and harmful to patients who require access to this first-line treatment for limb-threatening ulcers. We therefore urge WPS to revise the proposed LCD and finalize updates that would provide coverage of debridement services for the conditions and circumstances noted above.
Limitations of WPS’ Approach to Evidence Review for the APMA Reconsideration Request
We are concerned that WPS’ review of the submitted evidence was too narrow to reach the correct conclusion regarding coverage of debridement for the above-listed ulcers. In our reconsideration request, we specified the following logical progression:

• Argument 1: Stage II pressure ulcers, ulcers with severity limited to breakdown of skin, and all diabetic foot ulcers can present with biofilm and/or devitalized tissue.i,ii
• Argument 2: Debridement is medically reasonable and necessary for ulcers that contain
• Logical Conclusion: Debridement is medically reasonable and necessary for Stage II pressure ulcers, ulcers with severity limited to breakdown of skin, and all diabetic foot ulcers that contain biofilm or devitalized tissue.

We note that this approach is necessary given the limited availability of direct evidence to support debridement for wound care. However, as stated by the National Pressure Ulcer Advisory Panel (NPUAP), “there is strong informed clinical consensus to support the role of debridement in wound bed preparation, despite the ethically understandable lack of randomized controlled trials directly comparing debridement to no debridement in human subjects.”v

For Argument 1 and Argument 2, we presented articles supporting each statement (see citations provided above). Additionally, we argued that diabetic foot ulcers require separate coverage under the LCD given that there are some diabetic ulcers that do not fall under the category of ulcers with neuropathy or neuroischaemia, and we presented evidence in support of this statement as well.vi Consistent with Argument 1, these diabetic foot ulcers can also present with biofilm or devitalized tissue.
However, rather than reviewing the evidence to determine whether our arguments were supported, and then drawing logical conclusions, WPS narrowly focused on whether each article addressed debridement for the types of ulcers specified in the reconsideration request. This narrow approach to WPS’ review of the evidence fails to accept clinically important and valid evidence that supports a thorough understanding of standard wound care and management practices, including debridement to remove biofilm and devitalized tissue – regardless of the type of wound.
It also fails to acknowledge the challenges that accompany evidence development when standards of care are clearly established, as noted in the NPUAP statement above. Rather than take a narrow approach to review of evidence, we urge WPS to instead review the evidence, as intended, to draw reasonable logical conclusions regarding the medical necessity of debridement for the above-specified ulcers.
Diabetic Foot Ulcers Separate from Neuropathic and Neuroischaemic Ulcers
Below we present additional evidence supporting the existence of diabetic foot ulcers that do not qualify as neuropathic or neuroischaemic ulcers.

• Gupta et al. vii note in Table 1 that there are three major types of diabetic foot ulcers, including ischemic ulcers only, without neuropathy.
• Lipsky et al.viii note that diabetic foot infections (DFIs) usually arise either in a wound caused by some form of trauma, in addition to ulcers that arise as a consequence of neuropathy.

Presence of Biofilm and/or Devitalization in Stage II Pressure Ulcers, All Diabetic Foot Ulcers, and Chronic Non-Pressure Ulcers with Tissue Severity of “Limited to Breakdown of Skin”
Below we present additional support to demonstrate the potential presence of biofilm and/or devitalization in Stage II pressure ulcers, all diabetic foot ulcers, and chronic non-pressure ulcers with tissue severity of “limited to breakdown of skin”:

• Pullen et al. ix document the need for and use of debridement for stage II pressure ulcers that exhibited fibrinous and/or necrotic slough.
• Schultz et al.x offer consensus guidelines that specify that “Biofilms are present in most chronic wounds, and are likely to be located both on the surface and in deeper wound layers, but may not be present uniformly across or within the wound.”

With respect to Stage II pressure ulcers, in particular, we recognize that WPS relies on the NPUAP guidelines for determining that these ulcers would not be devitalized and therefore not require debridement. However, we have concerns that the NPUAP staging classifications do not adequately capture all potential ulcers. Specifically, it is not clear how ulcers with partial thickness skin loss with slough would be characterized. NPUAP specifies that Stage II ulcers demonstrate “partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister.”
NPUAP also specifies that Stage III ulcers demonstrate full thickness tissue loss.xi Under these classifications, ulcers with partial thickness skin loss with slough are not recognized at all, even though such ulcers routinely manifest in the course of ulcer progression. As applied by WPS, this gap in the NPUAP classification system has resulted in patients losing access to first-line wound care that can treat and manage wounds early, before they increase in severity and harm.
Debridement as a Reasonable and Medically Necessary Standard of Care for Ulcers that

Contain Biofilm or Devitalized Tissue
Below we present additional evidence demonstrating that debridement of ulcers with biofilm or devitalized tissue is a reasonable and medically necessary standard of care, including for stage II pressure ulcers, diabetic foot ulcers without neuropathy or neuroischaemia, and chronic non-pressure
ulcers with a tissue severity of “limited to breakdown of skin.”

• Many sources detail the “TIME” or “DIME” principles of wound bed preparation, which include that if tissue is non-viable or deficient, then debridement is necessary to restore the wound base and extracellular matrix proteins (see Dowsett and Newtonxii; Gupta et. alxiii; Halim et al. xiv, and Sibbald et al. xv as examples). This paradigm is included in medical school curricula on appropriate wound management, including the vast majority of colleges of podiatric medicine.xvi
• Attinger and Bulanxvii provide a comprehensive overview of the role of debridement in wound care, including detailing why debridement is necessary for wound care and the role that debridement plays in wound healing. It specifically mentions debridement of skin.
• Lavery et al.xviii offer updated guidelines for treatment of diabetic foot ulcers from the Wound Healing Society (WHS). Guideline 3.1 directs wound care providers to remove all necrotic or devitalized tissue by surgical, enzymatic, mechanical, biological, or autolytic debridement. Likewise, Guideline 4.2 specifies that initial debridement is required to remove the obvious necrotic tissue, excessive bacterial burden, and cellular burden of dead and senescent cells. Maintenance debridement is needed to maintain the appearance and readiness of the wound bed for healing. These guidelines are largely mirrored in previous 2006 WHS guidelines (see Steed et alxix), demonstrating the well-established nature of this standard of care. These same guidelines are also reflected in Marston et al.xx, which provides updated guidelines for treatment of venous ulcers, which may include chronic
  ulcers that are limited to breakdown of skin. Both guidelines specify that the aim of wound bed preparation is to convert the molecular and cellular environment of a chronic wound to that of an acute healing wound.
• Game et al. xxi provide guidance on treatment of chronic diabetic foot ulcers and reflect the conclusions based on a systematic review undertaken by the International Working Group on the Diabetic Foot. Recommendation 2 addresses removal of slough, necrotic tissue, and surrounding callus, and notes that the majority of national guidelines emphasize that debridement is an essential part of good wound care.
• Armstrong and Asiaxxii report via UpToDate, an online subscription-based resource of peer-reviewed content run by Wolters Kluwer, that “wounds that have devitalized tissue, contamination, or residual suture material require debridement prior to further wound management” and that “debridement of necrotic tissue is important for ulcer healing.”
  UpToDate supports daily clinical decision support activities for physicians across 25 different specialties, consistent with clinical evidence.
• Hingorini et al.xxiii also provide clinical guidelines for management of diabetic feet, including recommending sharp debridement of all devitalized tissue and surrounding callus material from diabetic foot ulcerations at 1- to 4-week intervals. These guidelines reflect a multi-disciplinary collaboration across the Society for Vascular Surgery, the Society for Vascular Medicine, and APMA.
• Lipsky et al.xxiv likewise provide clinical practice guidelines from the Infectious Diseases Society of America for the diagnosis and treatment of diabetic foot infections. They specify in recommendation 7 that clinicians should debride any wound that has necrotic tissue or surrounding callus. In recommendation 42, they note that diabetic patients with a foot wound should receive appropriate wound care, which usually includes debridement,
  which is aimed at removing debris, eschar, and surrounding callus. They also note that “assessment for infection requires first debriding any necrotic material or callus,” and they also detail the benefits of debridement as it relates to infection prevention and treatment.
• Wounds Internationalxxv also demonstrates that debridement of devitalized tissue reflects the standard of care internationally. Wounds International specifies that “debridement should remove all devitalised tissue, callus, and foreign bodies down to the level of viable bleeding tissue.” It also specifies that treatment of biofilms should “aim to disrupt the biofilm burden through regular, repeated debridement and vigorous wound cleansing.”
• Snyder et al.xxvi translate the standard of care into a standardized checklist for evaluating lower extremity chronic wounds to assist clinicians in optimizing patient care. Included in the checklist is a step focused on removal of unhealthy tissue from the wound through debridement. Snyder et al. note that, while a healthy wound bed should heal without debridement, the presence of necrotic or nonviable tissue will determine whether a wound
  requires debridement.
• Schultz et al.xxvii offer consensus guidelines specifying that “Debridement is one of the most important treatment strategies against biofilms” along with other treatment strategies, and also notes that “surgical or conservative sharp wound debridement (CSWD) are effective ways to help remove biofilm from the surface of an open wound in which biofilm is suspected.”
• Wolcott et al.xxviii find that sharp debridement facilitates therapeutic treatment of biofilm by increasing susceptibility to antibiotic treatments.
• Wolcott, Kennedy, and Dowdxxix and Malone and Swansonxxx also discuss the value of debridement for biofilm.
• Wilcox JR, Carter MJ, and Covington Sxxxi demonstrate in wounds of all causes that frequent debridement healed more wounds in a shorter time.

Prohibiting debridement for various types of ulcers that exhibit biofilm or devitalization, including stage II pressure ulcers, diabetic foot ulcers without neuropathy or neuroischaemia, and chronic non-pressure ulcers limited to breakdown of the skin, fails patients by increasing their risk for complications and withholding medically necessary care until wounds increase in severity. It is also inconsistent with care provided throughout the rest of the Medicare program, as WPS is the only Medicare administrative contractor (MAC) to prohibit debridement for these specific types of wounds. Finally, it places providers in the untenable position of having to choose between either providing care that is inconsistent with their medical training, clinical guidelines, and the standard of care, thereby placing them at liability for malpractice claims, or foregoing reimbursement for medically necessary care that supports their ability to continue in the practice of medicine.

Conclusion

For the reasons noted above, we urge WPS to revise the proposed LCD and finalize updates that would provide for coverage of debridement services for stage II pressure ulcers, diabetic foot ulcers without neuropathy or neuroischaemia, and chronic non-pressure ulcers with severity limited to breakdown of skin when biofilm or devitalization is present. David G. Edwards, DPM, President; Gail M. Reese, JD Assistant Director

The comment is reviewed and well received with numerous references to pertinent literature. WPS agrees with the comment. See the final LCD and Billing and Coding Article for more clarification.

On behalf of the American Association for Wound Care Management (“AAWCM”), I am pleased to submit comments in response to the Draft Wound Care LCD DL37228. AAWCM is a nonprofit trade association representing the interests of hospital-based wound care clinics, wound care clinicians and people with chronic and non-healing wounds. Through advocacy in regulatory, legislative and public arenas, our mission is to promote access to quality multidisciplinary wound care in a hospital-based setting.
We are writing to express our deep concern that the Draft LCD, as currently written, continues to unreasonably restrict or prohibit a number of well-established care practices– without reasonable clinical justification. These restrictions are preventing providers from using clinically appropriate medical interventions in a manner consistent with current clinical literature and clinical practice. Specifically, we are troubled by the continued limitation of coverage for debridement and the lack of scientific evidence to support the care restrictions in the Draft Wound Care LCD DL37228.

These are not new concerns they date back to the Final Wound Care LCD 37228 which became effective 4/16/2018. These concerns were noted by The Alliance of Wound Care Stakeholders and the American Podiatric Medical Association (APMA) in their many detailed requests for clarification, correction and ultimately a reconsideration on that LCD.

Since the release of the Final Wound Care LCD, clinicians and hospitals have been denied payments for providing services to wound care patients while adhering to debridement recommendations detailed in at least five separate specialty society clinical care guidelines. (Per Dr. Noel’s request, copies of these guidelines were provided to WPS electronically after the Open Meeting on 11/22/2019.) Had clinicians provided care based on the WPS Wound Care LCD coverage policy instead of accepted standard clinical practice, patients would have received substandard and potentially limb threatening care. ²

In both the prior Final Wound Care LCD and this Draft Wound Care LCD, WPS incorrectly limited the practice of appropriate debridement in several ways. Below, we list the inappropriate limitations along with our rationale and recommendations for revised language.
1. WPS removed debridement coverage for chronic non-pressure ulcers when the severity is classified as “limited to breakdown of skin” by eliminating codes ICD-10 L97.111-L98.497 in the Local Coverage Article.

Because of these omissions, providers have been denied payment for appropriately using these codes. Despite several requests for justification for removal of these codes, WPS has not provided sound evidence or rational for their exclusion. Rather, WPS simply stated there was inadequate evidence to support inclusion.

As noted above, we submitted the clinical practice guidelines from five specialty societies outlining the appropriate use of debridement. The Alliance of Wound Care Stakeholders and APMA submitted numerous articles since the April 2018 implementation date and in their comments on this draft. We echo those examples of strong evidence.

Further, adding to the evidence, we highlight a recent article by Tettelback et al¹. This article details evidence of the benefit of debridement through a sub analysis of RCT data evaluating the thoroughness of debridement and its influence on healing outcomes. Results of the Cox regression analysis found that variation in the thoroughness of debridement played an important role in ultimate healing outcomes.

¹ Tettelback et al A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicenter, randomized, controlled study of 110 patients from 14 wound clinics. Int Wound J. 2018: 1-111 https://doi.org/10.1111/iwj.12976

Finally we would note that WPS historically included these codes prior to April 2018 and that all other MACs with wound care LDCs currently cover these codes.
We respectfully request that WPS revise the companion Local Coverage Article and reinstate ICD-10 codes L97.111-L98.497.
2. WPS instructs providers to bill an Evaluation and Management (E/M) code when the severity is classified “as limited to breakdown of skin” and a debridement was performed. (Note: a separately identifiable service distinct from the debridement is not typically performed during routine wound care visits).

This WPS instruction is contrary to coding guidelines which require that a procedure be coded to the highest level of specificity which would be the use of CPT codes 97597 and 97598. Billing an E/M creates a compliance issue as the coder would be billing for reimbursement and not the service that was performed. Since coders will not deviate from coding convention that requires them to code the procedure rendered to the highest degree of specificity, providers are currently being denied payment for providing appropriate care. 3

We request WPS comply with CPT coding requirements and allow debridement coverage (CPT code 97597/97598) for chronic non pressure ulcers with a tissue severity of limited to breakdown of skin.
3. WPS lists conditions which must be present and documented in order for a debridement to be covered. WPS includes Neuropathic and Neuroischaemic Ulcers but not Diabetic Foot Ulcers (DFUs).

While many diabetic ulcers have a neuropathic or neuroischaemic component not all do. A diabetic patient can have an ulcer caused by ischemia with small vessel disease but without neuropathy. By narrowing the list to only include patients with a neuropathic component, WPS is limiting debridement to a subset of diabetic ulcers. When asked about this deletion, WPS claims there is insufficient evidence for inclusion.
However, debridement of DFUs (not just those with a neuropathic component) is the accepted standard of care as outlined in clinical practice guidelines and numerous articles about the treatment of chronic wounds. Further, WPS does not cite any evidence to the contrary to justify exclusion of DFUs from the list.
Because of the vast number of conditions represented by over 1700 distinct ICD-10 diagnoses codes of wounds or ulcers that require debridement, we recommend WPS eliminate the list of conditions that need to be met in order to perform a debridement. This rationale would be consistent with other MACs (i.e. Novitas, NGS, FSCO). Both Novitas and FCSO state the following in their LCD “It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM codebook appropriate to the year in which the service is rendered for the claim(s) submitted.
If WPS decides to go forward with this list, we respectfully request the addition of Diabetic Ulcers.

AAWCM appreciates the opportunity to submit comments to WPS on this draft coverage guidance and thanks you for your consideration of our feedback and concerns. Further, as our membership includes a broad group of wound care practitioners with extensive chronic wound care knowledge and experience and organizations with wound care specific databases, we would be pleased to serve as a resource to you now or in the future. Jule Crider, Executive Director, American Association for Wound Care Management

1 Tettelback et al A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicenter, randomized, controlled study of 110 patients from 14 wound clinics. Int Wound J. 2018: 1-111 https://doi.org/10.1111/iwj.12976

After review of comments and additional literature, WPS agrees with the commenter. See the final LCD and Billing and Coding Article for clarification on policy.

MiMedx Group, Inc. thanks you for the opportunity to comment on DL37228 Wound Care and the accompanying billing article A5509, which are under reconsideration. We appreciate that WPS honors reconsideration requests from the public and thereby allows thorough examination of guiding coverage criteria.

As Health Policy Director for MiMedx, I would also like to say I enjoyed the opportunity to be at the recent open meeting in Madison. I greatly appreciated the time the WPS team took after the meeting to speak with the attendees. As my first time attending a WPS open meeting, it was nice to put some faces to names.

It would be helpful to me if you could send a very brief response so that I know this went through. Thank you—we truly appreciate your time and consideration!

Attached please find:

 Dear Dr. Holzmacher and the WPS Policy Team,
MiMedx Group, Inc. thanks you for the opportunity to comment on DL37228 Wound Care and the accompanying billing article A5509, which are under reconsideration. We appreciate that WPS honors reconsideration requests from the public and thereby allows thorough examination of guiding coverage criteria.

Firstly, we offer support for much of the proposed LCD. Specifically, the current document does a good job of recognizing the variability of the needs of wounds by not imposing an arbitrary cap on debridement per year. While reduction in wound area is an important measure of healing, we are also especially heartened that the LCD continues to recognize other important indicators, such as appropriateness of drainage, inflammation, swelling and pain.

MiMedx is aware that other commenters have requested that WPS review and give rightful weight to guidelines put forth by the Infectious Diseases Society of America, Society for Vascular Surgery, International Working Group on the Diabetic Foot, Wound Healing Society, and Wounds International. MiMedx also agrees with other commenters who point out that inclusion of “neuropathic” and “neuroischemic” ulcers does not adequately cover the needs of the Diabetic Foot Ulcer (DFU) population, since many DFUs are neither neuropathic nor neuroischemic.

Debridement is the gold standard across all chronic wound types; MiMedx echoes the requests of other commenters on this matter, but wishes to add the data, articles and comments below as part of the considered evidence.

In terms of items under reconsideration, we submit comments on the following:

1. New data that supports the inclusion of DFUs on the list of etiologies appropriate for debridement 
2. Inconsistency between the LCD (omission of DFUs) versus the article (inclusion of DFUs) as diagnoses appropriate for debridement
3. A disconnect between current AMA CPT code descriptors versus the proposed LCD regarding selective debridements

A: New data from patients enrolled in a Randomized Controlled Trial supports the inclusion of Diabetic Foot Ulcers on the list of etiologies appropriate for debridement

In relation to Diabetic Foot Ulcers, the current proposed LCD states under Analysis of Evidence, that “No study was presented to show clear evidence that debridement improves ulcer healing.”

However, data from two recent DFU RCTs address this question by examining adequate debridement as a subset of healing in both the control arm (Standard of Care) as well as in the treatment arm (Standard of Care + Advanced Therapy).^1,2 Please see enclosed full-text studies: Tettelbach et al., 2019 and Tettelbach et al., 2018.

Although the primary goal of the RCTs was to evaluate the efficacy of dehydrated Human Amnion Chorion Membrane (dHACM) or dehydrated Human Umbilical Cord (dHUC), retrospective evaluation regarding the adequacy of wound debridement was used to examine clinical and demographic factors influencing healing.

Both RCTs utilized a team of blinded physician adjudicators (who did not have enrollees in the studies), as well as the Silhouette camera ((ARANZ Medical, Christchurch, New Zealand). The Silhouette camera, is an imaging device that precisely and consistently measures the area, depth and volume of wounds and their healing progress, was used to obtain wound measurements at all study sites. Wound measurements were taken pre-debridement as well as post-debridement.

The physician adjudicators were blinded to study site and patient group assignment. The purpose of the blinded adjudication was to assess healing, but also adequacy of debridement for each patient, for each visit where debridement occurred. Per study protocol, frequency and voracity of wound debridement was at the discretion of the site investigator, although use of chemical debridement agents was not allowed. Coupled with the multi-center, multi-state study design, this increases the likelihood that this data subset more accurately captures “real-world” debridement practices.
For both studies, adequate debridement was defined retrospectively as occurring when post-debridement images revealed exposure of healthy tissue in the ulcer with no significant eschar, callous, necrotic tissue or foreign material present in or around the wound.

Below are the statistics specific to debridement, as published in each of the studies. MiMedx believes that this new, quantifiable evidence shows the value of debridement in the healing trajectory of Diabetic Foot Ulcers.

EpiFix (dHACM) study outcomes related to debridement¹
Per-Protocol (PP)

• Subjects identified in the PP cohort as having inadequate debridement were 71% less likely to heal within 12 weeks when controlling for covariates. (p=0.005)

Intent-To-Treat (ITT)

• Subjects identified in the ITT cohort as having inadequate debridement were 64% less likely to heal within 12 weeks, when controlling for covariates. (p=0.022)

EpiCord (dHUC) study outcomes related to debridement 2

Intent-To-Treat

• Intent-to-Treat with adequate debridement with EpiCord & SOC – 96% healed at 12 weeks (p<0.001)
• Intent-to-Treat with adequate debridement with SOC alone – 65% healed at 12 weeks (p<0.001)

The studies provide evidence that sharp debridement in chronic DFUs influences rates of healing. The EpiFix study outlines the beneficial mechanism of action associated with debridement: “Sharp debridement facilitates growth factor delivery by restoring the expression of growth factor receptors that are not properly expressed at the non-healing edge of chronic ulcers, thus making insensitive cells more responsive to exogenous growth factor therapy.” ^1,3

B: Inconsistency between the LCD (omission of Diabetic Foot Ulcers) versus the article (inclusion of Diabetic Foot Ulcers) as diagnoses appropriate for debridement

As outlined above in Point A, MiMedx registers concern for the omission of Diabetic Foot Ulcers as an etiology appropriate for debridement, and therefore reimbursement for debridement. MiMedx also comments that because of discrepancies in LCD language versus the billing article code lists, the overall intent that WPS has for DFU debridement is not clear:

• Within the LCD:
  • The Coverage Indications, Limitations and/or Medical Necessity declines to list DFUs as a condition appropriate for debridement.
  • The Rationale for Determination makes it clear that the omission of DFUs is purposeful, but points to one study that speaks to the positive effect of debridement on neuropathic diabetic foot ulcers.
    
    
• However, billing and coding article A55909 is at odds with the LCD:
  • Group 1 paragraph outlines that it inclusive to both types of sharp debridement (selective 97597-97598 and excisional 11042-11047).
  • Group 1 specifically lists diabetic foot ulcer codes: E08.621, E09.621, E10.621, E11.621 and E13.621. These DFU codes do not have a neuropathic component, and are therefore are at odds with the explanations and exclusions given within the LCD. The reader is left confused.
  • Moreover, Group 1 differs with the LCD in terms of what is left out: Group 1 does not include any diabetic codes that are descriptive of neuropathy or polyneuropathy. These codes are captured within the ICD-10 classification with the suffixes .40, .42, .42, and .43. As an example with type I Diabetes:
  • E10.40—Type I diabetes with diabetic neuropathy unspecified
  • E10.41—Type I diabetes with diabetic mononeuropathy
  • E10.42—Type I diabetes with diabetic polyneuropathy
  • E10.43—Type I diabetes with diabetic autonomic (poly) neuropathy

MiMedx submits that the LCD (which does not allow for debridement of DFUs unless they are neuropathic) and the article (which allows for the debridement of all DFUs, but does not list any diabetic neuropathy codes) are out-of-sync, leading to confusion among providers and other readers. Based on the clinical evidence and guidelines submitted in point A, above, we request that the LCD be updated to include Diabetic Foot Ulcers and to bring the LCD into alignment with the article and (most importantly) good and widely-accepted clinical practice.

We also note that the article does not list any non-pressure chronic ulcer codes with descriptors “limited to breakdown of skin.” Please note that ulcer selection in both the EpiFix and EpiCord RCTs (described in point A, above) comprised partial and full thickness ulcers. We believe these studies speak to the value of debridement in all depths of DFU, including shallower ulcers captured by ICD-10 codes “limited to breakdown of skin.” Along those lines, we are including resources (full text articles) reflecting that the majority of open chronic wounds, including Wagner Grade I and II DFUs, are susceptible to biofilm.4,5 Malone et al. notes that biofilms were identified in >78% of biopsies of chronic wounds. It has also become scientifically accepted that biofilm in a chronic wound bed can upregulate inflammation (as expressed by an increased level of MMPs, interleukins) thus delaying wound closure and putting the patient at risk for complicationsno matter the depth of the wound bed. Sharp excisional debridement is the best-known mechanism to remove (effectively) biofilm from a hard-to-heal wound bed. Therefore, MiMedx urges WPS reflect the value of debridement for all depths of diabetic wounds, by including the full range of non-pressure chronic ulcer codes (including those “limited to breakdown of skin”) within both the LCD language and code series within the article.

C: A disconnect between AMA CPT code descriptors versus LCD regarding selective debridements

Lastly, MiMedx echoes other commenters in urging WPS to reexamine its use of code descriptors versus coverage within the LCD. We find the language surrounding selective debridements to be inconsistent, and therefore confusing to providers and other readers.

• The use of scissors forceps for selective debridement code 97597 and 97598. Please note that the official 2019 Current Procedural Terminology (CPT) description, as issued by the American Medical Association, specifically allows for the use of scissors and forceps to compliantly capture these codes.
  
  The current LCD acknowledges this in some places. However, in the LCD section labeled: “The following services may be done during wound care services and can be medically necessary, but they are not considered wound debridement services and wound debridement CPT codes should not be used,” it states that a scalpel or curette must be used or else a debridement code should not be applied. This is at direct odds with the selective debridement code description and is a point of confusion for the reader as well as other commenters.
  
  
• The removal of fibrin and biofilm under code 97597 and 97598. Please note that the official 2019 CPT descriptors for 97597 and 97598 specifically allow the compliant use of these codes to capture the removal of fibrin and biofilm as well as exudate and debris. Unlike with excisional debridement codes 11042-11047, use of 97597 and 97598 is not predicated upon removal of devitalized tissue. Language within the current LCD that points toward removal of fibrin, exudate and biofilm as not meeting the definition of any debridement code is at odds with the official code description and is confusing to providers and other readers.

In summary, MiMedx again thanks WPS for acknowledging the need to re-examine this LCD, by implementing the defined public reconsideration processes. We reiterate our support for much of the document, and appreciate the thoughtfulness and expertise behind it.

As a reminder, MiMedx is the manufacturer of two industry-leading placental membrane grafts (EpiFix and EpiCord). Please note that MiMedx is dedicated to continuous and rigorous scientific and clinical investigation of its placental products. The primary purpose of the two Randomized Controlled Trials (above) was to examine the clinical efficacy of EpiFix and EpiCord under well-powered, randomized, multi-center and multi-state studies. We are pleased with the results, which for both products showed a significant improvement in healing (as defined by complete closure with no drainage) in comparison to those ulcers treated by Standard of Care (SOC) alone:

However, as a company, we are also pleased to provide secondary data that enhances the understanding of wound healing overall. The most successful use of our grafts is dependent on the cornerstone of good standard of care, even prior to the initiation of treatment with our advanced therapies. For diabetic foot ulcers, adequate debridement is integral to good standard of care. Through the submission of new published clinical data, as well as our reflections as a public consumer of the published LCD and article, we hope to have successfully painted the picture that allows inclusion of DFUs for debridement under WPS, along with greater alignment and clarity between the WPS LCD and article.

• Our MiMedx formal comments on the draft LCD
• The following full text articles as enclosures:
  1. Tettelbach W, Cazzell S, Reyzelman AM, Sigal F, Caporusso JM, Agnew PS. A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics. Int Wound J. 2019 Feb;16(1):19-29.
  2. Tettelbach W, Cazzell S, Sigal F, Caporusso JM, Agnew PS, Hanft J, Dove C. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Int Wound J. 2019 Feb;16(1):122-130. doi: 10.1111/iwj.13001. Epub 2018 Sep 24. PMID: 30246926
  3. Malone M, Bjarnsholt T, McBain AJ, James GA, Stoodley P, Leaper D, Tachi M, Schultz G, Swanson T, Wolcott RD. The prevalence of biofilms in chronic wounds: a systematic review and meta-analysis of published data. J Wound Care. 2017 Jan 2;26(1):20-25.
  4. Oates A, Bowling F, Boulton, A, Bowler P, Metcalf D, McBain, A. The visualization of biofilms in chronic diabetic foot wounds using routine diagnostic microscopy methods. Journal of Diabetes Research. Volume 2014, Article ID 153586 http://dx.doi.org/10.1155/2014/153586

William Tettelbach, MD
Jennie Feight, MS, CPC, CPMA, CPC-I

Comments reviewed and agree with commenter. Attached literature reviewed. WPS agrees and please see final LCD and Billing and Coding Article for clarification on policy.

The American Occupational Therapy Association (AOTA) is the national professional association representing the interests of more than 213,000 occupational therapists, occupational therapy assistants, and students of occupational therapy. The science-driven, evidence-based practice of occupational therapy enables people of all ages to live life to its fullest by promoting health and minimizing the functional effects of illness, injury, and disability. Occupational therapy practitioners help to improve Medicare beneficiaries’ quality of life and participation in meaningful life occupations. We appreciate the opportunity to comment on Wisconsin Physicians Service Insurance Corporation (WPS’s) draft local coverage determination (LCD) for Wound Care (referred to hereinafter as “draft LCD”).

AOTA offers the following comments and recommendation for your consideration

Occupational Therapists Are Providers of Wound Care Services

Wound care is well within the scope of practice for occupational therapy practitioners with regards to the prevention and amelioration of wounds and their impact on daily life. Occupational therapy practitioners routinely work with individuals who are at risk for and have sustained wounds. A number of clinical details and case scenarios regarding occupational therapy practitioners’ role in wound care can be found in AOTA’s official document, The Role of Occupational Therapy in Wound Care¹. AOTA’s Model Definition of Occupational Therapy for State Practice Acts² includes wound care as being within the Occupational Therapy scope of practice, as does its Scope of Practice official document.³ Occupational therapists and occupational therapy assistants routinely work with individuals and populations who are at risk for or have sustained wounds, and they provide many types of wound care interventions, which are outlined in the AOTA official document cited above.

¹ The Role of Occupational Therapy in Wound Management - Official Document (2018)
² AOTA Definition of Occupational Therapy Practice for AOTA Model Practice Act (2011)
³ Scope of Practice Document official AOTA document (2014)

Therefore AOTA was pleased to see that the draft LCD specifically references “therapist” as a general term in the document which would allow occupational therapy practitioners to be reimbursed for the essential care they provide to individuals with wounds (as indicated in the note posted to the draft LCD in the Medicare Coverage Database (MCD)):

“When wound care is provided by the Therapist, for either in or out patient wound care, the medical record is required to have the following documentation…” Page 2 of 2 AOTA Comments Proposed LCD: Wound Care (DL37228).

However, AOTA respectfully requests that the LCD also reference the role of occupational therapy assistants (OTA) in providing wound care interventions under the supervision of the occupational therapist. Therefore, to be inclusive of therapy assistants, we urge WPS to use the phrase “therapist and therapy assistant” rather than simply “therapist”, so that the revised language would read as follows:

“When wound care is provided by the Therapist or Therapy Assistant, for either in or out patient wound care, the medical record is required to have the following documentation…”

AOTA also noted that under “Synopsis of Changes”, WPS referenced a revision of language for clarification to expand “therapist” acting within their scope of practice and licensure may provide debridement services (97597/97598). Our review of the draft LCD as well as the associated Local Coverage Article for Billing and Coding: Wound Care did not find that specific language, although we do note that the article does indicate that “The documentation must also reflect that the skill set of a therapist was required to perform this service [CPT Codes 97597, 97598, and 11042-11047] in the given situation.” An occupational therapist or occupational therapy assistant is bound by the Occupational Therapy Code of Ethics (2015) to demonstrate competency in the services they perform.⁴ Therefore, we respectfully request that the language from the Local Coverage Article for Billing and Coding: Wound Care (substituting the phrase “therapist or therapy assistant” for “therapist”, as referenced above) also be included in the debridement language in the LCD so as to provide consistency and clarity.

Additionally, AOTA noted that in the Documentation section, while the above referenced note posted to the draft LCD revises the sentence and first bullet point (“Physician order(s) for therapy /wound care services and signed plan of treatment”) to remove references to “physical therapist” and “physical therapy” in favor of terminology that acknowledges all therapy practitioners, the second and seventh bullet points still reference “PT/wound care”. We want to ensure that WPS is cognizant that the current language in the draft LCD is counter to the intent of the revisions. AOTA urges WPS to make the LCD text consistent with the other revisions and read “therapy/wound care” in the final version, rather than “PT/wound care”.        Julie Lenhardt Manager, Reimbursement and Regulatory Policy

The LCD specifically list "therapists" to be inclusive of both PT and OT. WPS recognizes the ability of OT to perform wound care within the defined state scope of practice.

The Board of Directors and the Public Policy Committee of the National Pressure Injury Advisory Panel (NPIAP) (formerly known as the NPUAP), are reaching out to you in response to the Draft Local Coverage Determination for Wound Care (DL37228).

The NPIAP is an independent, not-for-profit professional organization dedicated to the prevention and management of pressure injuries. Formed in 1987, the NPIAP Board of Directors is composed of leading experts from diverse health care disciplines—all of whom share a commitment to the prevention and management of pressure injuries. The NPIAP serves as a resource to health care professionals, government, the public and health care agencies. The NPIAP welcomes and encourages the participation of those interested in pressure injury issues through the utilization of NPIAP educational materials, participation at national conferences, and support of efforts in public policy, education and research

The NPIAP suggests that further clarification, research and/or edits for this measure would be beneficial pertaining to the following points:

1. Wisconsin Physician Services (WPS) identifies conditions, which must be present and documented for a debridement to be covered. The policy states: “At least ONE of the following conditions must be present and documented:

• Pressure ulcers, Stage III or IV,..”

NPUAP would like to suggest that this list utilize the nomenclature of Pressure Injury as well as a change from roman numerals to numbers. The NPIAP Pressure Injury Definitions are:
- Pressure Injury: A pressure injury is localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by microclimate, nutrition, perfusion, co-morbidities and condition of the soft tissue.

- Stage 1 Pressure Injury: Non-blanchable erythema of intact skin Intact skin with a localized area of non-blanchable erythema, which may appear differently in darkly pigmented skin. Presence of blanchable erythema or changes in sensation, temperature, or firmness may precede visual changes. Color changes do not include purple or maroon discoloration; these may indicate deep tissue pressure injury.

- Stage 2 Pressure Injury: Partial-thickness skin loss with exposed dermis Partial-thickness loss of skin with exposed dermis. The wound bed is viable, pink or red, moist, and may also present as an intact or ruptured serum-filled blister. Adipose (fat) is not visible and deeper tissues are not visible. Granulation tissue, slough and eschar are not present. These injuries commonly result from adverse microclimate and shear in the skin over the pelvis and shear in the heel. This stage should not be used to describe moisture associated skin damage (MASD) including incontinence-associated dermatitis (IAD), intertriginous dermatitis (ITD), medical adhesive related skin injury (MARSI), or traumatic wounds (skin tears, burns, abrasions).

- Stage 3 Pressure Injury: Full-thickness skin loss Full-thickness loss of skin, in which adipose (fat) is visible in the ulcer and granulation tissue and epibole (rolled wound edges) are often present. Slough and/or eschar may be visible. The depth of tissue damage varies by anatomical location; areas of significant adiposity can develop deep wounds. Undermining and tunneling may occur. Fascia, muscle, tendon, ligament, cartilage and/or bone are not exposed. If slough or eschar obscures the extent of tissue loss this is an Unstageable Pressure Injury.

- Stage 4 Pressure Injury: Full-thickness skin and tissue loss Full-thickness skin and tissue loss with exposed or directly palpable fascia, muscle, tendon, ligament, cartilage or bone in the ulcer. Slough and/or eschar may be visible. Epibole (rolled edges), undermining and/or tunneling often occur. Depth varies by anatomical location. If slough or eschar obscures the extent of tissue loss this is an Unstageable Pressure Injury.

- Unstageable Pressure Injury: Obscured full-thickness skin and tissue loss Full-thickness skin and tissue loss in which the extent of tissue damage within the ulcer cannot be confirmed because it is obscured by slough or eschar. If slough or eschar is removed, a Stage 3 or Stage 4 pressure injury will be revealed. Stable eschar (i.e. dry, adherent, intact without erythema or fluctuance) on the heel or ischemic limb should not be softened or removed.
- Deep Tissue Pressure Injury: Persistent non-blanchable deep red, maroon or purple discoloration Intact or non-intact skin with localized area of persistent non-blanchable deep red, maroon, purple discoloration or epidermal separation revealing a dark wound bed or blood filled blister. Pain and temperature change often precede skin color changes. Discoloration may appear differently in darkly pigmented skin. This injury results from intense and/or prolonged pressure and shear forces at the bone-muscle interface. The wound may evolve rapidly to reveal the actual extent of tissue injury or may resolve without tissue loss. If necrotic tissue, subcutaneous tissue, granulation tissue, fascia, muscle or other underlying structures are visible, this indicates a full thickness pressure injury (Unstageable, Stage 3 or Stage 4). Do not use DTPI to describe vascular, traumatic, neuropathic, or dermatologic conditions.

2. The policy states: “At least ONE of the following conditions must be present and documented:

• Pressure ulcers, Stage III or IV,..”

NPIAP has concerns with the verbiage of “Pressure ulcers; Stage III and Stage IV” excluding all other pressure injuries from inclusion for debridement. NPUAP believes that Unstageable should be included as part of this list. For example, it is quite often that it is clinically appropriate for an Unstageable Pressure Injury to require debridement, which is often more than once, to provide the necessary care. NPIAP suggests adding this condition to the list. NPIAP suggests adding additional language of “Should a DTPI, or Stage 2 progress to an unstageable, Stage 3 or Stage 4 requiring debridement then documentation supporting this must be included in the medical record for reimbursement of the debridement.”
The NPIAP would be happy to continue our ongoing collaboration with Wisconsin Physicians Services and CMS to support the educational needs associated with the full understanding of these terms and measures necessary for accurate clinical classification/staging. Thank you for the opportunity to comment.

Sarah Holden-Mount, PT, CWS Public Policy Chair
Jill M. Cox, PhD, RN, APN-C, CWOCN Public Policy Chair
Janet Cuddigan, PhD, RN, CWCN, FAAN President

Comments have been reviewed and after review, WPS agrees with comments and suggested language changes. See final LCD and Billing and Coding Article for details.

On behalf of the Alliance of Wound Care Stakeholders (“Alliance”) I am submitting comments on the Draft Local Coverage Determination for Wound Care (DL37228). The Alliance is a nonprofit multidisciplinary trade association of physician specialty societies, clinical and patient associations whose mission is to promote evidence-based quality care and access to products and services for people with chronic wounds including diabetic foot, venous stasis, pressure and arterial ulcers. Our clinical specialty societies and organizations not only possess expert knowledge in treating complex chronic wounds, but also in wound care research.

The Alliance has been on the record four times to address our concerns with how WPS is limiting coverage on debridement and not providing adequate scientific evidence to support its coverage policy. We provided comments to the draft LCD in June 2017 and followed it up with both formal letters and emails in June and October 2018 as well as in February 2019 requesting clarification of clinically inaccurate information in the final LCD.

After reading WPS’s decision to not update its wound care LCD, the Alliance once more reiterates our concerns with this flawed policy including:

1. This current LCD as well as the LCD issued in 2017 seem to have no foundation in medical evidence or clinical practice guidelines and are not supported by meaningful citations in the bibliography. This is in violation of CMS’s Program Integrity Manual.
2. The rationale for WPS rejecting the evidence submitted in the APMA reconsideration is not reasonable.
3. WPS eliminated a significant number of CPT codes related to debridement of other chronic non-pressure ulcers when the severity is classified as limited to breakdown of skin without providing adequate evidence for eliminating these codes.
4. WPS eliminated codes related to post-thrombotic syndrome with ulcer and inflammation and chronic venous hypertension without providing adequate evidence for eliminating these codes.
5. WPS has specifically identified a limited number of conditions which must be present in order to provide a debridement, yet left out a significant number of conditions which require it. There is evidence to support that debridement is the standard of care when treating patients with wounds; therefore either WPS should not include a list of conditions or add a rather lengthy list of conditions such as: diabetic foot ulcers, Stage II pressure ulcers, deep tissue injury, osteomyelitis just to name a few.
6. WPS seems to have taken liberties with CPT codes that have already been established by the AMA, accepted by CMS, and utilized verbatim by other contractors and private insurers. WPS does not have the discretion to change CPT code descriptors to suit their purpose and cover certain items within the code while denying others. This is in direct violation of CMS’s Program Integrity Manual.
7. WPS included NPWT information within this LCD, which conflicts with an already existing DMEMAC NPWT LCD. Therefore, this conflicting information is confusing to providers. It is baffling why WPS needs to provide utilization parameters in this policy when there is a DMEMAC policy already in place.
8. There are clinical errors/inaccuracies contained in the policy, as has been identified previously but ignored by WPS.

Our specific comments follow.

WPS Draft Wound Care LCD Has No Foundation in Medical Evidence or Clinical Practice Guidelines and Is Not Supported By Citations Listed In The Bibliography

In this draft Wound Care LCD, WPS has decreased coverage for debridement, limited the codes accepted for coverage and limited the conditions that are required to be present in order for a debridement to be performed. The evidence that WPS has cited since 2017 in the LCD bibliography to support its decision to decrease coverage is not sufficient nor is it supportive of the language in the policy. We submit that language in the LCD does not have any foundation in medical evidence.

Clinical experts have provided WPS with evidence to support their positions that debridement is a standard of care to treat patients with wounds as well as to reinstate the codes which were eliminated and expand the limited list of conditions which need to be met to perform a debridement (if they need to be listed out at all). However, none of that evidence has been cited in the WPS bibliography.

According to CMS’s Program Integrity Manual (PIM) 13.7.1, the evidence supporting an LCD “shall be based on the strongest evidence available”. The initial action in gathering evidence to support LCDs shall always be a search of published scientific literature for any available evidence pertaining to the item or service in question. WPS not only did not gather all the evidence that exists when developing this LCD, it used data that is not clinically sound nor comports to the standards of practice based on clinical practice guidelines. The evidence that WPS has cited is not compelling to demonstrate that the debridement procedures which WPS eliminated are

either unsafe and/or ineffective. WPS has also not brought forth expert consensus among clinicians and scientists that debridement for these types of ulcers or conditions are medically unnecessary. Yet, WPS specifically identifies certain procedures which are acceptable for a debridement and do not list others – such as diabetic foot ulcers - without providing evidence to justify its position. Many of the Alliance’s clinical association and physician specialty society members have clinical practice guidelines which very clearly provide evidence that not only is debridement the standard of care for wound care, but also is necessary for appropriate wound healing. However, none of these practice guidelines seem to be reviewed by WPS or they would have been cited in the bibliography for this LCD.

It is very unusual for clinical practice guidelines established by specialty societies and associations, which clearly identify a standard of care, to be ignored by Medicare contractors. Yet, WPS has done just that. For the most part, the clinical evidence that is stated in the reference section of the Wound Care LCD bibliography is not topical or relevant to debridement. The Alliance submits that the language in this policy which limits coverage of debridement by eliminating CPT codes for coverage as well as limiting the conditions that need to be present to perform a debridement flies in the face of standards of care and best practices. Furthermore, WPS does not provide the necessary evidence to support its position to do so. WPS has continuously ignored the clinical community and the evidence provided by them. WPS has continually ignored requests for evidence that was utilized in forming its decisions. While there has been evidence placed in the bibliography, none of it supports the WPS position to decrease coverage OR to eliminate coverage for established CPT codes. Based on the evidence cited in the bibliography, and more importantly the evidence that was omitted, the Alliance submits that WPS has failed to adhere to the above PIM guidelines for limiting and/or decreasing coverage as well as rejecting the APMA reconsideration request.

Alliance recommendation: The Alliance recommends that when developing LCDs WPS ensures that it not only utilizes its experts (CAC members), but also reviews ALL clinical evidence including clinical practice guidelines. This will help to ensure that WPS is meeting their requirements under the PIM. Furthermore, when citing evidence utilized in the policy to support WPS positions, the Alliance recommends creating subheadings to identify what evidence was used to support each section in the policy. This not only helps the reader to better understand whether the evidence cited was used to create policy language for example for ultrasound, maggot therapy or debridement, but will also allow stakeholders to better identify what evidence was not reviewed by WPS. This will assist exerts to better be able to provide WPS appropriate evidence to review.

The Rationale for WPS Rejecting the Evidence Submitted in the APMA Reconsideration is Not Reasonable

WPS was dismissive of evidence provided to it not only through the reconsideration request submitted by the American Podiatric Medical Association (APMA), but also of evidence provided by the Alliance as requested by the MAC. One example of the dismissiveness includes the information cited from the Electrical Stimulation NCD. WPS stated that this reference was “not relevant to the request.” Yet, within the CMS NCD, CMS addressed a standard of care and specifically stated within that NCD:

“ Standard wound care includes: optimization of nutritional status, debridement by any means to remove devitalized tissue, maintenance of a clean moist bed of granulation tissue with appropriate moist dressings, and necessary treatment to resolve any infection that may be present”.

While this national coverage determination recognized a standard of care that has been established over time and through routine clinical practice, we have grave concerns that WPS completely dismissed this evidence citing that the NCD did not address debridement for the types of ulcers specified in the reconsideration request. Again, the point of providing the NCD language was to highlight CMS recognition of debridement as a standard of care. WPS did not find that language to be compelling or on point to accept the NCD evidence submitted.

The manner in which WPS dismissed all the evidence submitted to it follows the same pattern - if the study was not specifically on point, it was dismissed. This is concerning. Debridement is the standard of care. Evidence development when standards of care are clearly established is not typical. WPS would be hard pressed to find studies on point as a result. But, there are studies and clinical practice guidelines that clearly establish debridement is the standard of care. Thus, the rationale that studies need to be specific to a certain type of condition or they will not be accepted is not reasonable. Furthermore, by WPS not accepting the absolute fact that debridement is the standard of care and thereby limiting the debridement that can be performed is not only harmful to patients, it is harmful to clinicians who can be subjected to malpractice for not adhering to their clinical practice guidelines and/or standards of care.

Alliance recommendation: Experts have provided evidence to justify debridement as the standard of care when treating patients with wounds. WPS needs to revise the LCD accordingly.

Chronic Non-Pressure Ulcers When The Severity Is Classified As Limited To Breakdown Of Skin

WPS has removed debridement coverage for chronic non-pressure ulcers when the severity is classified as “limited to breakdown of skin”. The CPT® manual describes 97597 as the appropriate code to utilize when only epidermis and/or dermis are debrided. This WPS policy is contradictory to the definition and goals of debridement that is included in the WPS “Coverage Indication, Limitations and/or Medical Necessity” section of the Wound Care LCD which states: “Debridement is defined as the removal of foreign material and/or devitalized or contaminated tissue from or adjacent to a traumatic or infected wound until surrounding healthy tissue is exposed.”

Since the WPS LCD states that a debridement is proper for “the removal of foreign material and/or devitalized or contaminated tissue from or adjacent to a traumatic or infected wound until surrounding healthy tissue is exposed”, CPT code 97597 and 97598 would be used to remove devitalized tissue from the dermis or epidermis level. However, WPS is instructing that providers bill an E/M code when the severity is classified “as limited to breakdown of skin”. This is contrary to common coding and billing practices. It is our understanding that physicians and hospitals should code procedures to the most specific 2 codes, which in this case would be 97597 and 97598, if the ulcers are greater than 20 sq.cm. The Alliance urges WPS to comply with CPT coding and allow debridement coverage (CPT code 97597/97598) for chronic non pressure ulcers with a tissue severity of limited to breakdown of skin (this coverage is consistent with all other Medicare Administrative Contractors (MACs) and other 3rd party payers (commercial insurance companies).

Furthermore, the rationale provided to the Alliance for leaving out diagnosis codes with respect to chronic non-pressure ulcers when the severity is classified as “limited to breakdown of skin (ICD- 10 L97.111 – L98.497) was that the main purpose of the policy is to “discuss wound care for wounds that are refractory to healing or have complicated healing cycles either because of the nature of the wound itself or because of complicating metabolic and/or physiological factors”.

We have the following concerns with respect to this rationale:

1. First, other jurisdictions, including Novitas and FCSO state the same point in their policies yet still permit these codes to be utilized as they recognize the necessity of debridement for these types of wounds.
2. Second, these codes were included in the WPS policy prior to 2017 when WPS revised its LCD for wound care. The decrease in coverage was not supported by any evidence in the bibliography contained in the LCD. If there is a decrease in coverage, WPS is required to have provided the evidence it used to justify the decreased coverage.
3. Finally, under this policy, WPS is allowing patients to become sicker by not permitting clinicians to appropriately treat their patients by providing a clinically sound procedure - which is not only clinically appropriate - but established in standards of care. Furthermore, WPS is creating a deficiency in the level of care that a patient receives in its jurisdiction compared to others; thereby, creating an imbalance in patient care. A patient in Texas and Florida will get different care than a patient in the WPS jurisdiction. This is not the intent of the program. WPS is creating inequity in the standard of care of patients with the same conditions in other parts of the country who are clinically covered. This is contrary to the integrity and intent of the Medicare program. In addition to creating inequity in the standard of care patients receive, the Alliance would appreciate WPS explaining its intent in creating this disparity.

Alliance recommendation: Once again, the Alliance recommends that the diagnosis codes related to chronic non-pressure ulcers when the severity is classified as “limited to breakdown of skin (ICD- 10 L97.111 – L98.497) be reinstated.

Post-thrombotic Syndrome with Ulcer and Inflammation and Chronic Venous Hypertension

In addition to chronic non-pressure ulcers when the severity is classified as “limited to breakdown of skin (ICD- 10 L97.111 – L98.497), WPS has omitted numerous ICD-10 codes that support medical necessity for post-thrombotic syndrome with ulcer and inflammation and chronic venous hypertension.

Alliance recommendation: These codes need to be reinstated for similar reasons as stated above.

Conditions That Need To Be Met In Order To Perform Debridement

WPS identifies conditions which must be present and documented in order for a debridement to be covered. The policy states: “At least ONE of the following conditions must be present and documented:

• Pressure ulcers, Stage III or IV,
• Venous or arterial insufficiency ulcers,
• Dehiscenced wounds,
• Wounds with exposed hardware or bone,
• Neuropathic ulcers,
• Neuroischaemic ulcers,
• Complications of surgically created or traumatic wound where accelerated granulation

The Alliance is very concerned that WPS has decided to list out a limited number of conditions that need to be met in order for a debridement to be performed and covered. There are 1,747 distinct ICD-10 diagnosis codes of wounds and ulcers that require debridement. To limit the conditions that must be present in order for a clinician to be permitted to perform a debridement is clinically unsound and unreasonable. A patient who requires a debridement of a wound does not always have one of the conditions present that WPS has identified in this LCD. Yet debridement IS the standard of care when treating patients with a chronic wound– whether their condition is listed in this policy or not.

Debridement is a well known and utilized procedure in the treatment of chronic wound care. It is effective and necessary. There is evidence to support its use that both the Alliance and our clinical association members have submitted to WPS. There are numerous review articles on the preparation of the chronic wound bed to support healing and clinical practice guidelines - adopted by professional societies - which address the fundamental importance in debridement in the management of chronic wounds. While all of these guidelines cannot address each and every clinical scenario in which debridement should be performed, it is very clear that debridement is the standard of care when treating patients with wounds. Yet, it appears that if a study does not specifically address a specific condition, then WPS will not allow for that condition to be listed as one of the conditions that must be present to be able to perform a debridement – despite every clinical organization stating that it is the standard of care.

In APMA’s reconsideration request, WPS dismissed the evidence submitted because it was not specific enough to include diabetic foot ulcers in the list of conditions. However, not only was the evidence sufficient for WPS to include them in the list of conditions, but it should have also accepted clinical practice guidelines for diabetic foot ulcers which clearly state that debridement is the standard of care when treating this type of ulcer. There certainly is evidence to support diabetic foot ulcers being listed in the conditions which need to be met for a debridement to be performed. But there are many conditions which require debridement which may not have the same level of evidence as diabetic foot ulcers. The Alliance submits that when a standard of care has been established, one may not find studies for every type for every condition that debridement is medically necessary. There are studies to support debridement in the chronic wound care space for more conditions than were listed including diabetic foot ulcers as well as clinical practice guidelines, written by multiple specialty societies which highlight debridement as being the standard of care when treating this patient population for conditions that were not listed in the policy.

The Alliance does not believe that a list of conditions should be spelled out in this policy and question why WPS would limit debridement to a few conditions when so many others are present requiring debridement. We also question why WPS needs to list the conditions when debridement is the standard of care when treating wound care patients. Data exists showing that debridement is successful in helping heal patients with wounds. In fact, there is evidence so suggest that the increased frequency of debridement helps to heal a wound.

The list of evidence that WPS has placed in the bibliography attached to the LCD does not justify the limitation of conditions. It is contrary to good wound care treatment protocols and standards of care. Either WPS needs to remove the list of conditions and provide language consistent with Novitas or FCSO, significantly expand the list of conditions or state the following language in the policy to ensure that the appropriate wounds will be eligible for debridement - “Debridement to be covered for any full thickness wound/site or partial thickness wound that has evidence of progressing to a full thickness wound.”

Alliance recommendation: The Alliance recommends that WPS provide guidance that is consistent with Novitas JL and JH and the FCSO Wound Care LCDs which state the following: “It is the provider’s responsibility to select codes carried out to the highest level of specificity and select from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted. No procedure code to diagnosis code limitations are being established at this time.” Should WPS not be so inclined to do so, then the Alliance recommends either significantly expanding the list of conditions that need to be present in order for a debridement to be performed or state the following language in the policy to ensure that the appropriate wounds will be eligible for debridement - “Debridement to be covered for any full thickness wound/site or partial thickness wound that has evidence of progressing to a full thickness wound.”

Negative Pressure Wound Therapy

WPS states that “the coverage of traditional Negative Pressure Wound Therapy (NPWT) device/unit/type, or supplies is covered under the Durable Medical Equipment benefit (Social Security Act §1861(s)(6)), and providers should consult their DME LCD for specific coverage, parameters, and guidelines”. However, in the utilization parameters, WPS goes on to limit the utilization of NPWT. Specifically, the language in the policy reads, “Negative pressure wound therapy services should not exceed a 120 day period. There should be no more than 4 dressing changes per wound per month for the majority of wounds.” It is alarming that WPS is providing NPWT utilization parameters in this policy rather than just simply refer to the already well established DMEMAC NPWT LCD. This policy is creating confusion among providers which is unnecessary.

Alliance recommendation: WPS delete information on NPWT and simply refer providers to the DMEMAC NPWT policy as has been done for electrical stimulation and other services referenced in this policy.

Lack of Adherence to CPT Code Descriptors

According to the Program Integrity Manual, the MAC “shall ensure that all LCDs do not conflict with statutes, rulings, regulations, and national coverage, payment and coding practices.” Yet throughout this LCD, WPS seems to take great liberties with CPT codes that have already been established by the AMA, accepted by CMS and used verbatim by all other contractors and private payers. WPS does not have the authority or the discretion to change CPT code descriptors and cover certain items within the code while denying others. This is in direct violation of CMS’s Program Integrity Manual. There are several areas in which WPS is in error.

The Alliance has already pointed out one instance of WPS containing language contrary to CPT code descriptors in its policy in our discussion above on debridement coverage for chronic non-pressure ulcers when the severity is classified as “limited to breakdown of skin”. However, there are several more instances in the LCD where WPS has violated the PIM and altering CPT.

Specifically, the LCD states the following:

The following services may be done during wound care services and can be medically necessary, but they are not considered wound debridement services and wound debridement CPT codes should not be used.

• Removal of necrotic tissue by cleansing, scraping (other than by a scalpel or a curette), chemical application, or wet to dry or dry to dry dressing. Generally, dressing changes are not considered a skilled service. The prior dressings are different and distinct from wet to moist dressings that are used for removal of devitalized tissue from wound(s) for non-selective debridement
• Removal of non-tissue integrated fibrin exudates, crusts, biofilms or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such

The Alliance is concerned that WPS has stated that certain procedures are not considered wound debridement services and therefore wound debridement CPT codes should not be used when the CPT descriptor clearly lists those items.

CPT 97597 states, “Debridement (e.g. high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel, and forceps), open wound (e.g. fibrin, devitalized epidermis and/or dermis exudate, debris, biofilm) including topical application(s), wound assessment, use of a whirlpool, when performed and instruction(s) for ongoing care, per session, total wound(s) surface area; first 20 sq. cm or less.”

WPS states that fibrin is not covered for a debridement when it is clearly listed in the 97597 code descriptor.

Similarly, 97597 clearly lists scissors and forceps when selective debridement is performed, yet WPS limits the removal of necrotic tissue to a scalpel or curette.

The Alliance has requested on multiple occasions for WPS to adhere to the CPT code descriptor language, but two years later, we are still making that recommendation. The Alliance again recommends that WPS needs to revise this policy so that it is consistent with the CPT code descriptors and not be in violation of the Program Integrity Manual.

Finally, the policy states, “While mechanical debridement is a valuable technique for healing ulcers, it does not qualify as debridement services”. Again, WPS is taking liberties with CPT. Mechanical debridement IS classified as a non-selective debridement within CPT code 97602.

As a reminder, there are surgical debridement codes (11042 – 11047). These codes are defined by the type of tissue removed – i.e., subcutaneous, muscle, bone. There are also medical debridement codes 97597, 97598 and 97602 that are defined as open wounds. The type of instrument used does NOT define these codes.

Alliance recommendations: WPS must make the above changes to the LCD in order to adhere to CPT code descriptor language as stated above.

Specifically, the LCD states the following:

The following services may be done during wound care services and can be medically necessary, but they are not considered wound debridement services and wound debridement CPT codes should not be used.

• Removal of necrotic tissue by cleansing, scraping (other than by a scalpel or a curette), chemical application, or wet to dry or dry to dry dressing. Generally, dressing changes are not considered a skilled service. The prior dressings are different and distinct from wet to moist dressings that are used for removal of devitalized tissue from wound(s) for non-selective debridement
• Removal of non-tissue integrated fibrin exudates, crusts, biofilms or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such

The Alliance is concerned that WPS has stated that certain procedures are not considered wound debridement services and therefore wound debridement CPT codes should not be used when the CPT descriptor clearly lists those items.

CPT 97597 states, “Debridement (e.g. high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel, and forceps), open wound (e.g. fibrin, devitalized epidermis and/or dermis exudate, debris, biofilm) including topical application(s), wound assessment, use of a whirlpool, when performed and instruction(s) for ongoing care, per session, total wound(s) surface area; first 20 sq. cm or less.”

WPS states that fibrin is not covered for a debridement when it is clearly listed in the 97597 code descriptor.

Similarly, 97597 clearly lists scissors and forceps when selective debridement is performed, yet WPS limits the removal of necrotic tissue to a scalpel or curette.

The Alliance has requested on multiple occasions for WPS to adhere to the CPT code descriptor language, but two years later, we are still making that recommendation. The Alliance again recommends that WPS needs to revise this policy so that it is consistent with the CPT code descriptors and not be in violation of the Program Integrity Manual.

Finally, the policy states, “While mechanical debridement is a valuable technique for healing ulcers, it does not qualify as debridement services”. Again, WPS is taking liberties with CPT. Mechanical debridement IS classified as a non-selective debridement within CPT code 97602.

As a reminder, there are surgical debridement codes (11042 – 11047). These codes are defined by the type of tissue removed – i.e., subcutaneous, muscle, bone. There are also medical debridement codes 97597, 97598 and 97602 that are defined as open wounds. The type of instrument used does NOT define these codes.

Alliance recommendations: WPS must make the above changes to the LCD in order to adhere to CPT code descriptor language as stated above.

Conclusion

The Alliance represents almost every physician specialty society and clinical association whose members treat patients with wounds and are the experts in their fields. Many of these organizations also have clinical practice guidelines which support debridement as the standard of care when treating patients with chronic wounds. The Alliance has provided links to these guidelines in Attachment A as well as additional evidence for WPS to consider (some of which we have provided in our comments in the past which was completely ignored). While WPS has provided some evidence in its LCD, our members have informed us thnone of the evidence is compelling to demonstrate that the debridement procedures which WPS has eliminated are either unsafe and/or ineffective. WPS has also not brought forth expert consensus among clinicians and scientists that debridement of these types of ulcers is not medically necessary. These are the standards that WPS must prove when citing evidence for a reduction in coverage for a certain item or procedure. However, WPS specifically identifies certain procedures which are acceptable for a debridement yet does not list others – such as for diabetic foot ulcers without providing evidence to justify its decision to include some and exclude others, despite debridement being considered the standard of care. The Alliance has requested this information in our emails and letters, yet it has not been provided to us or in the draft LCD. Our members are appalled at this policy. Simply stated, this policy does not uphold the standard of care and is unacceptable.

We request that WPS listens to the experts who treat these patients everyday – this policy is negatively impacting the care that our members provide to their patients in the WPS jurisdiction. Chronic non-pressure ulcers when the severity is classified as limited to breakdown of skin must be covered under this policy. We request that the codes that were contained in the WPS LCD prior to the Wound Care policy being finalized in 2018 be reinstated. If WPS finds a need to list out the conditions that must be present in order to receive a debridement, then we request that diabetic foot ulcers and many other conditions be added to the list of conditions that need to be present for debridement to be covered.

We appreciate the opportunity to provide you with our comments and hope that WPS will use us as a resource to ensure that the wound care policy in its jurisdiction is clinically accurate, is not in violation of CMS policy on CPT coding and is not providing disparate coverage to the patients our members serve.
Marcia Nusgart RPh Executive Director

WPS agrees the NPWT should follow DME MAC guidance and changes will be made accordingly. Please refer to final LCD for clarification on policy.

This letter is to advise you and WPS that I disagree with the final remarks that you and WPS concluded as a result of the reconsideration of Draft Proposed LCD DL37228. Prior to my retirement this year, I was a certified wound care specialist, working in a wound care clinic for eight years. As such, I am in a position to offer opinions on the standards of wound care. Administrative physicians, such as yourself are too far removed from patient care, to offer opinions on standards in the industry. It is interesting that WPS failed to reach out to expert physicians to determine standards in wound care, but rather came to their own conclusions, without knowledge or facts of how wounds are cared for in the real world.

The conclusions you published on the reconsideration surprised me. How can you as a non-clinical wound care physician, conclude facts that go against the standard of care in the wound care industry? You had no basis for your conclusions, and consequently failed to cite the evidence to support YOUR position on this matter. You are bound by the 21st Century Cures Act to provide the reference that you used to come to the conclusions that you did. You offered unsubstantiated opinions without any evidence to support your position. You also failed to review or understand the evidence that was submitted by the organization requesting the reconsideration, the American Podiatric Medical Association. You dismissed the evidence supporting their position, and yet failed to offer evidence to support your position. This is unacceptable to the requirements of the LCD reconsideration process as defined by the 21st Century Cures Act.

WPS in not an authority in wounds or wound care and therefore should not be offering opinions which carry no weight and has no evidence to support its position. WPS has chosen to ignore recommendations by authoritative organizations such as NPUAP, APMA, and the Alliance of Wound Care Stakeholders.

Issues

1. WPS has listed which types of ulcers will be covered. This “list” represents a narrow view by including some wounds and excluding other wounds. Ulcers by definition represent tissue loss. How can WPS determine that some forms of tissue loss can have treatment and other forms cannot? It is unreasonable for ANY organization to make this determination based on opinion only.
   • No other MAC has discriminated as to which tissue defect (type of ulcer) it will cover.
   • WPS is an outlier in this regard.
   • WPS considers that ALL of the other MACs are wrong in their coverage guidelines and that WPS alone has the correct position on this matter.
   • How can WPS explain to a patient in Davenport, Iowa, who has a diabetic ulcer without neuropathy or ischemia, that treatment of the ulcer is not necessary or payable, but if she would go across the Mississippi River into Moline, Illinois, the treatment for her ulcer IS COVERED. Do we tell her that the NGS MAC is wrong in its policy, or that WPS who stands alone with this opinion is wrong?
2. WPS has determined that Stage 2 pressure ulcers and other ulcers limited only to breakdown of skin do not require debridement and has stated “No study was presented to show clear evidence that debridement improves ulcer healing.”
   • If this quote is what WPS has determined to be relevant, then why does WPS allow debridement of wounds at all? Your statement contradicts the LCD by allowing debridement of some ulcer types. Please explain this!! Now that WPS has to abide by the LCD process as outlined by the 21st Century Cures Act, either allow debridement or disallow debridement, but not both. Also as required, cite your evidence to substantiate your position on debridement.
     WPS’ policies are inconsistent with the established standard of care for the treatment of wounds – the universally and widely accepted best practice for any wound exhibiting devitalized tissue is to debride that wound – regardless of the type of wound or its cause.

In this comment letter, I tried not to repeat the arguments that other authoritative organizations have commented on. I am taking a slightly different approach to my comments by discussing common sense in medical care. WPS has over extended its authority and taken a position on wound care that is contrary to standards of wound care, and contradicts what ALL authorities worldwide have concluded. WPS has done this without ANY evidence to support its position. I am requesting that WPS reconsider its faulty position on:

1. Limiting which types of ulcers can have treatment,
2. Which ulcer depths can or cannot have debridement.

I request that WPS follow the recommendations made by the American Podiatric Medical Association
Ed Prikaszczikow, DPM

No response is warranted as there was no pertinent information to consider.

On behalf of the Coalition of Wound Care Manufacturers (“Coalition”), I am submitting comments on the Draft Local Coverage Determination for Wound Care (DL37228). The Coalition represents leading manufacturers of wound care products used by Medicare beneficiaries for the treatment of chronic wounds including but not limited to surgical dressings, pneumatic compression devices and Negative Pressure Wound Therapy (NPWT).
Our comments are address solely the issue of Negative Pressure Wound Therapy that is contained in this draft LCD. In the utilization parameter section of the LCD, the language states, “Negative pressure wound therapy services should not exceed a 120 day period. There should be no more than 4 dressing changes per wound per month for the majority of wounds.” However, this seems to conflict with the DMEMAC LCD that states: “Coverage is provided up to a maximum of 15 dressing kits (A6550) per wound per month.
We question the rationale that WPS is using to include NPWT in its policy since this is clearly within the jurisdiction of the DMEMACs and their LCDs. This is not only confusing to our members but also the clinicians who use NPWT in their practices. Thus, we recommend that WPS eliminate the information on NPWT in this draft LCD and refer providers to the DMEMAC NPWT LCD.
The Coalition appreciates WPS’s consideration of these comments and would be pleased to answer any questions related to this matter. Karen Ravitz, JD Health Care Policy Advisor
Marcia Nusgart, R.Ph. Executive Director Alliance of Wound Care Stakeholders

WPS agrees the NPWT should follow DME MAC guidance and changes will be made accordingly.

I’m writing regarding the proposed LCD for diabetic foot ulcers. The podiatry profession has a long history of preventing amputations in diabetics and other at risk patience. In my opinion implicating this LCD would markedly increase the risk of amputation for at risk patients. Please reconsider this determination as I feel it would be a catastrophe for the diabetic population. This LCD would also be a tremendous financial hardship for Medicare. There would be a dramatic increase in partial foot amputation’s as well as below the knee amputations.         Kevin C Dodson DPM(FACFAS)

Thank you for your professional opinion regarding our proposed LCD.