Submitted Comments

The Coalition submitted comments to the medical directors of each Medicare Administrative Contractor (MAC) with specific recommendations to improve the local coverage determinations/local coverage articles on "Skin Substitute Grafts/ Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers." Coalition recommendations spanned a broad range of issues, including: 

• Evidence: the Coalition recommended that the MACs provide the GRADE criteria or protocols utilized to evaluate CTP evidence prior to this policy becoming finalized
• Reconsideration processes: the Coalition recommended that the MACs remove the product-by-product evaluation from the LCD and instead place in an Appendix or in the LCA so the entire LCD does not have to be reopened every time new evidence is reviewed; urged the MACs to provide an efficient and timely process for manufacturers to submit additional published evidence or other data to support movement of products located within the non-covered Group 3 to the covered Group 2 list.
• Implementation timeline: the Coalition recommended that patients on a current plan of care protocol when the policy is implemented be grandfathered so they are able to complete the plan of care established by their clinician based on current LCD language. 

See comments

• CTPs/(skin substitutes)
• Medicare Administrative Contractors (MACs)

The Coalition provided oral testimony at the open public feedback sessions that each Medicare Administrative Contractor (MAC) held to collect stakeholder input on the proposed LCD "Skin Substitute Grafts/Cellular & Tissue-Based Products for the Treatment of DFU and VLU.”  Coalition testimony urged:

• consistency in the evidence that is being accepted by the MAC and transparency as to what metrics were utilized to review the evidence,
• transparency in its criteria for product coverage and requested that the MACs publish what they consider an adequate trial design and outcome to gain coverage,
• clarity on the time frame and process a manufacturer will need to undertake when submitting evidence for consideration.

The comments below were delivered to: CGS Administrators (5/16/2024); First Coast Service Options (5/23/2024); National Government Services (5/16/2024); Noridian Healthcare Solutions (J-E on 5/16/2024; J-F on 5/16/2024); Novitas Solutions (5/24/2024); Palmetto GBA (5/29/2024) and WPS Insurance Corporation (5/22/2024). 
See oral testimony

In comments submitted to the FDA's proposed rule on classification of certain wound dressings and the accompanying requirements for premarket approval applications, the Coalition flagged the many "gaps and ambiguities" in the current policy, the reduced availability of wound dressing products that could result, and the harm this could cause to wound management and patient outcomes. Given these significant concerns, the Coalition requested that the Agency withdraw the policy for futher vetting. "Limiting access to these products could lead clinicians to prescribe more systemic antibiotics, which will adversely affect antibiotic resistance and stewardship initiatives. Furthermore, if FDA wants to proceed, in addition to the impact analysis, we request that it publish a new proposed classification rule and companion guidance with details regarding special controls and test standards that are currently lacking, estimates of the true cost of the proposed rule so as to ensure currently marketed products stay on the market with their current indications and without the need to submit new 510(k)s," the Coalition wrote. 

See Coalition Comments

The Coalition submitted comments to CMS's proposed 2024 Hospital Outpatient Prospective Payment System (HOPPS) focused on the CTPs (skin substitutes) section of the proposed rule, flagging patient access issues as well as inconsistency in the way products are being treated in both payment and coverage depending on the HCPCS code being issued despite the products all being categorized as skin substitutes. The Coalition recommended that CMS withdraw its policy to package payment and instead utilize ASP +6 for all skin substitutes and publish all data in the pricing data file. "Given the mandatory submission of ASP for all skin substitutes, CMS should use the data that is already being provided to it to form the payment for any given skin substitute," the Coalition wrote. To address inequities in the current payment system that continue to create barriers to access, the Coalition elevated the following recommendations - each of which was endorsed by the Agency's Advisory Panel on Hospital Outpatient Payment:

1. assign the existing CPT® add-on codes (15272, 15276, 15274, and 15278) and HCPCS codes (C5272, C5276, C5274, and C5278) to appropriate APC groups allowing for separate payment; and issue an exception to separately pay for these add-on codes.
2. assign the CPT and HCPCS codes for the same size wound, regardless of anatomical location on the body, to the same APC groups.
3. assign all new CTPs with both Q and A HCPCS codes to the low-cost APC groups until a manufacturer provides cost information to CMS.
4. realign both the high-cost and low-cost application procedure codes to higher paying APC groups that reflect the current average sales prices of all CTPs.
5. not assign CTPs that are not in sheet form (e.g., gel, powder, ointment, foam, liquid, or injected) to any APC group.

Read Coalition Comments

• CMS
• CTPs/(skin substitutes)
• HOPPS

The Coalition submitted comments to CMS' proposed 2024 Medicare Physician Fee Schedule voicing opposition to the Agency's proposal to treat CTPs (skin substitutes) as “incident to supplies” when furnished in non-facility settings and to include the costs of these products as resource inputs in establishing practice expense RVUs for associated physician’s services, rather than reimburse them separately. The Coalition outlined specific concerns, requested that CMS withdraw the proposal, and recommended instead that CMS maintain and enforce ASP pricing – "the most consistent pricing for CTPs that should and can be utilized across payment settings."
Read Coalition Comments

• CMS
• CTPs/(skin substitutes)
• Physicians Fee Schedule

The Coalition submitted comments to the proposed FY 2024 Hospital Inpatient Prospective Payment System (IPPS) highlighting support for the proposal related to the Hospital Harm – Pressure Injury electronic clinical quality measure (eCQM) included in the draft rule. "The Coalition supports and encourages the continued development of quality measures that assess wound care outcomes, as wound care clinicians should be required to report on measures that relate to the care that they deliver allowing CMS to effectively track and report the quality of that care. As such, we support the inclusion and adoption of the Hospital Harm - Pressure Injury eCQM. This measure is designed to reduce pressure injury prevalence through rate transparency utilizing complete data extraction of Electronic Health Records (EHR). We believe that pressure injury rate transparency will lead hospitals to identify and implement best practice improvements, which will reduce hospital-acquired pressure injuries," the Coalition wrote.
Read Coalition comments.

Following oral remarks made at CMS' January 2023 Skin Substitutes Town Hall meeting, the Coalition submitted written comments to expand upon its remarks and reiterate to the Agency that the proposed seismic changes to the payment methodology for CTPs ("skin substitutes") will lead to significant limitations on the access to care for numerous patient populations including but not limited to: minorities, patients in rural areas and patients with diabetes. "The bundling of skin substitutes is not in the best interest of Medicare beneficiaries who are likely going to be subjected to unnecessary anesthesia and longer waits to get their wounds treated as operating room time is difficult to come by. Most importantly, as a result of the potential to limit access to care, there could be increases in infections, amputations, and sadly, loss of life," wrote the Coalition. The Coalition urged CMS to NOT move forward with any proposed rulemaking for CY 2024, but instead to issue a "framework document" – as it did for 505 (2)(b) drugs – to allow for substantive information to be provided by the Agency for stakeholders to react to in a more informed fashion.  
Read Coalition comments

The Coalition provided oral comment at the Skin Substitutes Town Hall convened by CMS to collect stakeholder feedback related to changes in payment and terminology of skin substitute products under the Physician Fee Schedule. The Coalition provided perspective to the Agency on its four proposed questions, addressing: 1) What should we consider as part of CMS efforts to ensure consistent, fair, and appropriate payment for services and products across different settings of care? 2) How could we ensure that valuation under the PFS adequately accounts for variability in relative resource costs of different skin substitute products as supplies within the Practice Expense Relative Value Unit (PE RVU) methodology? 3) Are there similarly resourced groups of products/services that could inform how payment might be stratified without risking access to services? 4) What should we consider as alternatives regarding any potential changes to terminology?
The Coalition urged CMS to be more transparent and provide more information to stakeholders before any rulemaking on this issue takes place and recommended that the Agency issue a framework document prior to any rulemaking for stakeholders to respond to.

See Coalition Testimony

The Coalition submitted comments to Cigna Government Services (CGS) on its draft LCD for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36690) and the accompanying Local Coverage Article addressing Billing and Coding (DA56696). The Coalition voiced concerns that CGS created an LCD/LCA that was virtually verbatim to what was issued by Novitas and First Coast, whose own policies were fraught with clinical inaccuracies and were not supported by current clinical evidence. Specific policy provisions addressed in the Coalition's comments include:
- Application limitation over a 12 week timeframe
- Tissue Reference Group (TRG) letters
- Evidentiary requirements
- Coverage decisions being made in an article

The Coalition voiced its concerns with CGS's proposed LCD/LCA on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers with oral testimony at the Medicare Administrative Contractors' public meeting recommending that CGS withdraw the draft, then work with stakeholders and the CAC to craft a more accurate policy based on the most currently available evidence. The Coalition elevated its concern that CGS issued an LCD/LCA that is verbatim to what was issued by Novitas and First Coast, without doing its own due diligence to evaluate the evidence supporting the policies. The Coalition emphasized its concerns with:

1. The allowance of only 4 applications of a specific product is an arbitrary application limitation not based on evidence.
2. The inappropriateness of language in the policy that refers to CTPs as "surgical supplies" - which is clinically incorrect.
3. The lack of clarity and transparency on the specific evidence required of manufacturers in order for their products to be placed in the Group 2 covered product listing.
4. The lack of evidence to substantiate the significant changes that CGS is attempting to make. 

See Coalition Testimony