Comment 1: Several commenters support and encourage the new draft LCD for applying skin substitutes for wounds. Many support the LCD’s statement that “all products with FDA clearance/approval or designated 361 HCT/P exemptions used in accordance with the product’s individual application guidelines will be equally considered for the purpose of this LCD”. This expansion will enable physicians to make appropriate decision on medially necessary CTP products.

Response: Thank you

Comment 2: Commenter supports the proposed LCD’s updated classification of products into four groups defined as human skin allograft, allogeneic matrices, composite matrices, and acellular matrices.

Response: Thank you

Comment 3: several  commenters are concerned with the specific conservative care parameters required prior to application specific to venous stasis ulcers (VLU) be present for three months with conservative care for at least 30 days. Literature supports the four week observation period for all wounds and ulcers
Requested revision of this to, presence of a venous stasis ulcer that has been unresponsive to appropriate wound care for at least 30 days with documented compliance.

Several commenters ask what CGS considers appropriate wound care.

Response: The LCD is very clear as to what CGS considers appropriate wound care and those 4 weeks or more of wound care is required.

The LCD states:
Standard treatment of chronic lower extremity ulcers or skin loss (e.g., DFU or VLU) primarily includes infection and edema control, mechanical offloading, mechanical compression or limb elevation, debridement of necrotic or infected tissue, and management of concomitant and inciting medical issues (blood glucose control, tobacco use). Maintenance of a therapeutic environment with appropriate dressings to preclude further trauma facilitates development of healthy granulation tissue and encourages re-epithelialization. A wound that fails to show evidence of healing by contraction and advancement of epithelial margins following 4 weeks of optimization, including all aspects of standard therapy, is considered a chronic non-healing wound and falls into the auspices of this LCD. The fundamental basis for non-healing of a wound is of paramount importance and must be corrected prior to consideration of additional therapy.

Comment 4: Comment received requesting draft LCD include coverage only for products that meets threshold based on clinical efficiency and published studies as outlines in CMS program integrity manual chapter 13.

Response: The LCD already does this by accepting products that are FDA approved and/or meet FDA requirements for cellular based tissue products.

Comment 5: Add to human skin grafts from placenta/cord human tissue as well as cadavers.

Response: CGS will remove the term cadavers from the first bullet point under bioengineered skin substitutes.

Comment 6: Under regulatory status #1 commenter would like the following information added, products are recovered, processed, and distributed in compliance with FDA Good Tissue Practices and American Association of Tissue Banks (AATB) standards, maintain the necessary registration with the FDA, and undergo routine FDA inspection.

Response: CGS will add to the policy before finalizing.

Comment 7: Request to add the following under #10 in the documentation requirements: “each product material is for single-use only, and is not for use on multiple patients.”

Response: CGS will add before finalizing the policy.

Comment 8: Commenter would like a list of covered products to be included since Medicare Advantage programs use the Medicare MAACs LCD and if a list of covered products is not given the advantage program switched to a commercial payer policy.

Response: A list of covered product is included in the draft policy and will be included in the final version. A list of application HCPCs codes is also included in the CPT/HCPCS section.

Comment 9: Commenter would like the language above group 2 list of CPT/HCPCS codes to include the following language but would prefer the removal of the list of products from the policy.

The policy states that “all products … will be equally considered … and may be considered reasonable and necessary,” yet the policy states in Group 2 Paragraph, only the HCPCS codes listed may be covered: “Any HCPCS code that is not included in this list will not be separately reimbursed.”  Specific to this second statement in Group 2 Paragraph, a concern is that the list may not be inclusive of all Cellular and/or Tissue Based Products for Wounds (CTPs).  This could result in excluding new products that are subject to this draft LCD.  The commenter believes that misinterpretation and omission of products may result. 

The commenter requests that frequent and routine updates be scheduled to ensure the list remains current. In addition, since some products are FDA cleared, rather than approved, or are not subject to FDA approval or clearance, we request that the terminology in Group 2 Paragraph, “FDA approval” be modified.  Commenter proposes the following language: “May not be an all-inclusive list. New products and HCPCS codes will be considered eligible for coverage subject to meeting the necessary regulatory requirements and criteria of this policy.”  We respectfully request that this language be considered and addressed prior to issuing this policy in final.

Response: CGS agrees to add the language requested before finalizing.

Comment 10: Commenter would like CGS to use the old title, Application Cellular and /or Tissue-based Products for Wounds, Lower Extremities, for the new policy as well as replace skin substitutes with cellular and /or tissue-based products for wounds (CTPs).
Several commenters would like skin substitutes to be replaced with Cellular Tissue based products (CTPs) as this is a more accurate term to describe the products than skin substitutes. As well as FDA does not allow these products to not be called skin substitutes because they do not actually substitute for skin.

Response: CGS will change the title and all references of skin substitutes to read cellular or tissue based products (CTP) before finalizing the policy.

Comment 11: Would like the following sentence deleted as it implies there is no data supporting the improvement in response time for any CTP covered in the policy over standard care when there is clinical evidence available for many of the products in the policy that support improved healing for wounds that failed to progress with standard care approaches.

“Currently, no product has demonstrated individual superiority for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) of the lower extremity, and, frequently such products are utilized inappropriately.”

Response:  The sentence above will be kept in the policy as it states that there is no individual product that shows superiority.

Comment 12: Commenter has several changes in wording in the policy they would like to see take place before the draft becomes final.

• “A wound that fails to show evidence of healing by contraction and advancement of epithelial margins following 4 weeks of optimization, including SOC, is considered a chronic non-healing wound and falls into the auspices of this LCD. The fundamental basis for non-healing of a wound is of paramount importance and must be corrected prior to consideration of additional therapy.”

  This is not always clinically possible some can be corrected and are appropriate to correct prior to the application. There are systemic conditions that contribute to the wound response to healing that are not always correctable or require correction prior to treating a patient with a CTP.

  Please consider revising the sentence to, The fundamental basis for non-healing of a wound is of paramount importance and must be assessed and treated as appropriate per patient prior to consideration of additional therapy.

Response: We agree that systemic illnesses can and do influence wound healing. That is why we require control of these systemic processes prior to designating failure of standard care. We do not plan on changing this sentence or requirement at this time.

• “For purposes of this LCD a Failed Response is defined as an ulcer or skin deficit that has failed to respond to documented appropriate wound-care measures, has increased in size or depth, or has not changed in baseline size or depth and has no indication that improvement is likely (such as granulation, epithelialization or progress towards closing).”

  A failed response can also be when there has been minimal response from baseline depth or size.

  Please consider revising to, For purposes of this LCD a Failed Response is defined as an ulcer or skin deficit that has failed to respond to documented appropriate wound-care measures, has increased in size or depth, or has had minimal or no change in baseline size or depth and has no indication that improvement is likely (such as granulation, epithelialization or progress towards closing).

Response: CGS does not see any significant change in language requested by the commenter. To add the word “minimal” clouds the intent of the LCD and will lead to confusion in the provider community.

• Please consider revising this sentence, “Medicare covers application of skin substitutes to Ulcers or Wounds with Failed Response that are:

  • Partial- or full-thickness ulcers, not involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts, with a clean granular base.

  Since some of the products in the policy also have coverage indications for covering tendon and/or muscle to, Partial- or full-thickness ulcers, not involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts (except when a CTP product has an indication for these structures), with a clean granular base.

Response: CGS will review the language and clarify if the product is approved for use involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts as indicated by package labeling it would be the exception and allowed.

• Application of a skin substitute graft for lower extremity chronic wound (DFU and VLU) will be covered when the following conditions are met for the individual patient:

  • “Presence of neuropathic diabetic foot ulcer(s) having failed to respond to documented conservative wound care measures of greater than four weeks, during which the patient is compliant with recommendations, and without evidence of underlying osteomyelitis or nidus of infection.”

  Neuropathic ulcers are a distinct type of ulcer. Diabetes is but one cause of neuropathy and not all patients with diabetic foot ulcers have neuropathy. Please consider revising to  Presence of neuropathic ulcers and diabetic foot ulcer(s) having failed to respond to documented conservative wound care measures of greater than four weeks.

Response: CGS will change the language for this before finalizing the policy.

• Several commenters would like the following paragraph removed it is problematic with the language “specifically FDA-labeled or cleared for use” would eliminate any of the allograph and amniotic tissues that do not have specific labeling or clearance-based indications for use. We do not believe this is your intention.

  The language “considered to be biologic dressings” is incorrect. None of the listed products in the draft policy are a dressing. They are all reviewed as ‘biological’ materials, tissues, substrates or matrices and approved through FDA processes and under conditions of manufacturing distinct from those required for a simple wound dressing.

  The FDA recognizes different regulatory pathways for CTPs: PMA, 510K, HDE, BLA and HCT/Ps. CTPs have different regulatory pathways depending on the source of the tissue.

  A CTP promotes wound healing by interacting directly or indirectly with the body tissues.

  There is direct biological effect in the wound bed as a result. The role of CTPs is not to cover and protect wounds but rather to stimulate endogenous healing, although whether or not an individual CTP is capable of exerting effects on wound healing must be determined by adequate evidence. Yet, a wound dressing is a material that is utilized for covering and protecting a wound, helping to maintain an optimal wound environment, and shield the wound against the environment without exerting any direct effect in the wound bed. As such, it is not correct for CGS to determine that a CTP, which is being regulated as a human HCT/P with the FDA and has broad indications not specified in its labeling, to eliminate its use based on its regulatory classification, or to designate it as a wound dressing. Furthermore, none of the products that maintain a HCPCS Q code are or should be considered a wound dressing. This is simply clinically and scientifically inaccurate. The CMS allows separate Part B coverage and payment as biologicals in the physician office. They are not part of an E&M service.

  “All listed products, unless they are specifically FDA-labeled or cleared for use in the types of wounds being treated, will be considered to be biologic dressings and part of the relevant Evaluation and Management (E/M) service provided and not separately reimbursed.

  The statement above also contradicts the following language in the policy which commenters are in agreement with as it is more accurate and represents the Q code products.

  “All products with FDA clearance/approval or designated 361 HCT/P exemption used in accordance with that product’s individualized application guidelines will be equally considered for the purpose of this LCD and may be considered reasonable and necessary”.

Response: CGS will change the language to be more clinically accurate before finalizing the policy.

• Consider changing the 10 application to 12 since some of the products labeling is for weekly applications. The policy already limits treatment to 12 weeks with a CPT and also limits continued use of a product if there is no response within “a period of four weeks past start of therapy” as this would be considered “unsuccessful treatment”. There may be cases with very large and complex wounds, that more than 10 applications would be necessary to achieve closure. It seems unethical to withhold treatment that is effective just because there is a narrow time frame. For a majority of wounds treated with a CTP, there will be less than 12 applications. The total applications should match the indications for use of all the listed products.

  Consider, not to exceed 12 applications or treatments. In situations where more than one specific product is used during an episode, it is expected that the combined number of applications or treatments will still not exceed 12. There may be exceptions for very large wounds or those associated with autoimmune compromised conditions with appropriate documentation.

Response: At this time CGS has no plans to change the number of applications in the draft before finalizing the policy. If the scenario presented were to occur, then the medical record would have clear documentation as to the medical necessity  of such a treatment plan. Upon review/appeal the appropriate evidence will be reviewed. If we see that this happens frequently we will reassess changing the number of applications.

• Documentation of smoking history, and that the patient has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation (if applicable) as well as outcome of counseling must be in the medical record.

  It is reasonable to require documenting a patient’s smoking history and that they have received counseling on the effects of smoking on surgical outcomes. It is also reasonable to recommend a patient receive treatment for smoking cessation. However, it is unrealistic and adds no value to require the physician to document “outcome of counseling”. Patients can say one thing and do another. There is no way a phys

Response: Stating the smoking status of a patient in the record would de facto document the outcome of the smoking cessation counselling. No change will be made at this time.

Comment 13: Please add the following codes that appear in the 2017 proposed rule for the hospital OPPS:

Response: Since this rule is not finalized at this time CGS cannot add these codes at this time. Once the rule is finalized, changes may be made.

Comment 14: Commenter would like AlloPatch added to covered list as it is currently listed in the Application of Cellular and/or Tissue Based Products (CTPs) for Wounds of lower Extremities L34053.
Response: CGS will add any products that were added to the current policy after the drafting of DL36690 before it is finalized.

Comment 15: Comment received concerning that the following is unclear as to what combination therapy is and how it would limit the use of CTPs for a patient.
“Simultaneous use of more than one product is not covered.”

Response: CGS has seen providers use combinations of various products on one wound. At this time combination therapy or using more than one product on one wound is not covered.

Comment 16:  Would like CGS to recognize podiatrists as providers who can and do treat patients with wounds. As well as any other qualified health care professional in which this service is permitted to be performed within their state practice act.

Response:  As long as the provider stays within their scope of practice, CGS will pay them for their medically necessary services. The LCD is very clear that the treating physician must be actively treating any comorbid condition that may be hindering wound healing and that expertise must be able to be validated on request. The physician managing the systemic processes must be clearly identified. CGS will clarify that a provider treating a wound caused by a systemic condition would need to document they are aware of the condition and the patient is under the care of Dr. ___ for said condition unless (s) he is the one providing the care.

Comment 17: Comments received that would like the 12 week limitation be removed and simply state follow the FDA labeling as CTPs are only applied every 2-3 weeks with multiple treatments in a span of time beyond 12 weeks.  The provider would need to justify going beyond the 12 weeks. Also while CGS is permitting a clinician to change treatment options, this policy is still limiting a physician’s ability to change course in treating their patients upon the realization that the product chosen is not successfully working in their patient, or when the health status or wound changes. As such, this policy is not only limiting treatment options for the clinician, it is inhibiting a patient from receiving the best optimal treatment. As well as at time one CTP is used to achieve one goal and then another is utilized for closure of the wound.

Response: CGS is happy to review individual product’s labeling to determine if they require or have evidence that states the majority of treatments exceed our limitations. This LCD has regulatory guidance for the most common accepted application frequency. Exceptions do occur and CGS will handle these on a case-by-case basis on appeal as needed.

Comment 18:  Commenter would like language change concerning non-healing full thickness chronic wounds. While agreeing CTPs should not be used for wounds with a sinus tract. However, full-thickness wounds due to diabetes or venous disease as well as full thickness wounds that are the result of an abscess, trauma or injury often have exposed tendon, muscle or bone that can be appropriately treated with some CTPs that are indicted for with for wounds with exposed tendon, muscle or bone.
Please revise to:

• “lower extremity partial-or full-thickness diabetic ulcers, and venous ulcers not involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts, with a clean granular base” (except when a CTP has an indication for use over tendon, muscle, joint or bone. Use of a CTP in a wound with a sinus tract is not covered.)
• “Presence of a full thickness skin loss ulcer (any location) that is the result of abscess, injury or trauma that has failed to respond to appropriate control of infection, foreign body, tumor resection, or other disease process for a period of 4 weeks or longer.” If these full-thickness wounds involve exposed tendon, muscle or bone, only CTPs with indications for use over these structures will be covered.

Response: CGS is happy to review individual product’s labeling to determine if they require or have evidence that states the majority of treatments exceed our limitations. This LCD has regulatory guidance for the most common accepted application frequency. Exceptions do occur and CGS will handle these on a case-by-case basis on appeal as needed.

Comment 19: Would like the following removed from the limitations section since combination of therapies are used to enhance the healing of the patient.

“combination therapy with any skin substitute (CTP) will be considered not reasonable and necessary.”

Response: CGS CMDs require published peer reviewed literature in order to validate this request. CGS is happy to review this literature, if supplied by the commenter, and opine.