Submitted Comments

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

The Coalition submitted joint comments to Novitas and FCSO on their draft LCD for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041/DL38377) and the accompanying Local Coverage Article: Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117/DA57680). The Coalition expressed concern on a range of issues within the policy, including:

• Lack of a consistent and accurate definition of a chronic non-healing ulcer
• Description of CTPs as surgical supplies
• Limitation on number of applications of CTPs in an episode that is not supported by the clinical literature
• Requirement that clinicians use “the smallest package size available for purchase"
• Conflation of the terms “Wound” and “Ulcer” throughout the policy
• Incorrect description of the application of CTPs as an adjunct therapy rather than an advanced therapy
• Restriction on switching CTP products during course of therapy

Coalition comments
Attachment A - Group 3 Codes That Should Be Included In The Group 2 Covered Product List
Attachment B - ICD-10 Codes to be added to LCA

The Coalition submitted comments noting its disappointment in response to CMS' proposal to repeal the Medicare Coverage of Innovative Technology (MCIT). The Coalition urged CMS to not repeal the rule, and questioned its stated rationales for the repeal. Comments reminded the Agency of the many tools it has at its disposal that it could have employed – including coverage with evidence development as well as sub regulatory guidance – to move forward with implementing MCIT to help ensure that Medicare beneficiaries have expedited access to breakthrough diagnostic and therapeutic devices.
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The Coalition submitted comments to CMS'  CY 2022 Hospital Outpatient Prospective Payment System (HOPPS), flagging issues with the synthetic skin substitute section of the proposed rule. Comments focused on:
• the definition and coding of synthetic resorbable skin substitutes.
• payment inequities in provider based departments impacting Medicare beneficiary access to skin substitutes (also known as CTPs).
• the requirement to consult with the FDA Tissue Reference Group (TRG) or obtain a Request for Designation (RFD) regarding being appropriately regulated solely under section 361 of the PHS Act and the regulation in 21 CFR part 1271.
See Coalition Comments

The Coalition submitted comments to CMS' proposed CY 2022 updates to the Physician Fee Schedule and voiced objections to:

• The creation of new G codes for the application of synthetic skin substitutes;
• Considering synthetic products “incident-to” supplies;
• The packaging of skin substitutes in the physician office; and
• Using contractor pricing for synthetic skin substitutes.

The Coalition noted the impacts of these provisions and provided alternative recommendations for CMS consideration.
See Coalition comments

The Coalition submitted comments to CMS' CY 2022 Hospital Inpatient Prospective Payment System (IPPS) focused on provisions including Hospital Harm – Pressure Injury electronic clinical quality measure (eCQM) and adoption of Global Malnutrition Composite Score NQF #3592.

Read Coalition Comments

• CMS
• Prospective Payment System

The Coalition submited comments to CMS' Interim Final Rule regarding Medicare Coverage of Innovative Technology (MCIT). The Coalition applauded CMS for the rule getting innovative technologies to market faster. However, the Coalition raised concerns about issues surrounding the reasonable and necessary definition and counseled the Agency: "This portion of the rule should have been issued as a stand-alone proposal as the nature of it is separate from the MCIT rule and applies more broadly in the Medicare program. We recommend that the definition of reasonable and necessary be removed from the MCIT final rule so as to not further delay the implementation of the MCIT pathway. Then CMS can issue a stand-alone proposed rule to address the complexities of the reasonable and necessary definition by providing more clarification and addressing all the gaps that were contained in this proposal."
Read Coalition comments