Submitted 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

The Coalition sent a letter to Guidewell Source, the parent company of Medicare Administrative Contractors Novitas and First Coat Service Options, requesting that the two MACs withdraw their proposed Local Coverage Determinations (LCDs) Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041 and DL36377) and Local Coverage Articles (LCAs): Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117 and DA57680). The Coalition informed Guidewell that many of the provisions in the policies are  contrary to clinical practice guidelines and research, and in several instances are in conflict with the very evidence cited in the draft policies. The Coalition also urged Guidewell to intervene because the draft LCDs and LCAs violate several statutory provisions – which is problematic given the negative impact to patient care and access.
See the Coalition's letter

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

The Coalition submitted comments to Novitas and First Coast Service Option expressing its major concerns with the proposed LCD (DL35041/DL36377) and LCA (DA54117/DA57680) on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The comments follow initial submission of detailed feedback in May 2022 and oral testimony at MACs' August public meeting. The Coalition again raised the following objections in its submitted comments:

• The policies are not in the best interest of patients.
• The policies are not supported by clinical evidence or guidelines. Evidence has been omitted from the policy review. What has been utilized is either not the most currently available, or is used in such a way that is contradictory to the points Novitas/FCSO is trying to make.
• There is NO new evidence to support the movement of more than 40 products from the covered to the non-covered list.

See Coalition Comments

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

The Coalition submitted comments to CMS' proposed CY 2023 Hospital Outpatient Prospective Payment System expressing significant concerns with the "skin substitute" provisions of the proposed rule. "CMS states that changes to the coding and payment of skin substitutes are being made to provide clarity and consistency...Yet the changes being proposed do the exact opposite of these goals. The Agency continues to provide incremental changes without providing details on the larger picture on how skin substitutes will be paid. In fact, the changes that the Agency is making provides little clarity – and actually the opposite – it creates more confusion," the Coalition told CMS.
See Coalition Comments

The Coalition's submitted comments to CMS's 2023 Physician Fee Schedule adamantly oppose the  proposed policy changes to the way skin substitutes (CTPs) have been coded and reimbursed in the physician’s office for over 30 years by reclassifying skin substitute products as supplies and paying for them as part of the practice expense relative value units (RVUs) for the procedure with which they are used. These seismic changes 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 Coalition told CMS. This decrease in access to care may result in the likelihood of increased infection and amputations for these patients. The Coalition urged CMS to remove the provisions or, at very least, to delay the implementation of these provisions until more clarity is provided.
Read Coalition Comments

The Coalition spoke at the First Coast Service Option and Novitas public meetings and urged the Medicare Administrative Contractors to pull the problematic draft LCDs and LCAs on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers and work with stakeholders and the CAC to craft a more accurate and well balanced policy. "Clinical evidence continues to be omitted from this policy review," the placement of 40+ products from the covered to non-covered group is not supported by evidence or a reason for the movement, and the policy "continues to be fraught with clinical inaccuracies that ultimately will be detrimental to patient care," the Coalition told CMS.  
See Coalition comments to FCSO 
See Coalition comments to Novitas

The Coalition submitted comments to CMS' draft 2023 Hospital Inpatient Prospective Payment System (IPPS) recommending that the Agency:

• Include the Hospital Harm - Pressure Injury eCQM in the CY 2023 Inpatient PPS final rule, or alternatively, propose this eCQM in next year’s CY 2024 IPPS rule.
• Reinstate the PSI-90 composite measure or create a stand-alone quality measure for PSI-03, Pressure Ulcer Rates to maintain focus on pressure ulcers/injuries.
• Adopt as proposed and include in its final rule NQF #3992 the Global Malnutrition Composite Score.

Read Coalition Comments

• CMS
• Prospective Payment System