Submitted Comments

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

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.
Read Coalition comments

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