Submitted Comments

The Coalition is the respected and credible unified voice of manufacturers of wound care products and technologies. We advocate and educate policymakers, legislators, public and private payers and the other relevant entities to ensure patient and provider access to wound care products and services. We address a broad range of issues and product categories. Our submitted comments are below:

November 18, 2022

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 recommended that CGS pull the draft policies, then work with stakeholders and its Contractor Advisory Committee (CAC) to craft a more clinically accurate policy that is based on the most currently available evidence so that patient care will not be negatively impacted.
Read Coalition Comments




October 25, 2022
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
September 30, 2022
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
September 24, 2022
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
September 13, 2022
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
September 6, 2022
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
August 25, 2022
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
June 16, 2022
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
May 27, 2022
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
October 15, 2021
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
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