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:

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.

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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.
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September 17, 2021
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
September 13, 2021
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
June 22, 2021
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.

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April 16, 2021
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."
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March 15, 2021
In both oral and written comments submitted to Noridian regarding its draft wound care LCD (DL38902) , the Coalition flagged two key issues for the MAC to address: an incorrect definition of “advanced dressings” that needs to be expanded, and inconsistencies between the LCD (DL38902) and its accompanying LCA on billing and coding (DA58565) that have the effect of placing limits on debridement utilization parameters that are not included in the LCD. 

See Coalition Comments
November 2, 2020
The Coalition submitted comments to CMS' proposed rule regarding Medicare Coverage of Innovative Technology (MCIT) and the new definition of “reasonable and necessary." The Coalition encouraged CMS to establish a payment system for MCIT devices allowing for appropriate reimbursement - as without appropriate payment, the expanded MCIT coverage will be meaningless. We also recommended inclusion of provisions preventing the MACs from denying coverage of any technology eligible for new technology add-on payments or transitional passthrough payments. With regard to "reasonable and necessary," the Coalition expressed concerned about language which permits CMS to use commercial insurance medical policies for Medicare purposes.  "The Coalition is extremely concerned that CMS will cherry pick commercial payers that restrict coverage and therefore," we wrote in comments. "At this time, we do not support any definition of 'reasonable and necessary' that goes outside of what has already been published and adhered to in the Program Integrity Manual."
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October 5, 2020
The Coalition submitted comments to CMS' Proposed CY2021 Hospital Outpatient Prospective Payment System. Our comments primarily focused on the provisions relating to synthetic CTPS, and we urged CMS to:
  • Eliminate the new code C1849 ((“Skin substitute, synthetic, resorbable skin substitute per square centimeter) as it is inappropriate and not consistent with the coding for any/all other CTPs,
  • Remove placement of the C1849 synthetic CTP products from the high cost tier,
  • Require any synthetic CTP to apply for an appropriate HCPCS Q code to be considered a CTP.
Read Coalition Comments
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