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:

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.
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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.
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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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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.
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October 4, 2020

The Coalition submitted comments to the CY 2021 proposed physician fee schedule. We:

  • Recommended that CMS add codes for disposable negative pressure wound therapy (dNPWT) to the eligible telehealth list, 
  • Opposed CMS failure to adopt ALL of the RUC recommended work and time values for the revised office visit E/M codes for CY 2021, including and especially the RUC’s recommendation of commensurately including the updated E/M values in procedure codes with 10 and 90 day global periods.
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July 3, 2020
The Coalition submitted comments to CMS's COVID-19 Public Health Emergency Second Interim Final Rule that provided additional policy and regulatory revisions to provide flexibility during the pandemic. The Coalition focused on issues facing the wound care supplier and manufacturing communities, with specific recommendations for CMS to consider. These included:
  • Delaying the DME competitive bidding program;
  • Streamline Medicare billing for disposable negative pressure wound therapy (NPWT) furnished at home onto the standard form used by home health agencies;
  • Prioritizing DMEPOS suppliers’ access to personal protective equipment for treating COVID-19 patients in their homes;
  • Waiving all pre-authorization requirements for DMEPOS patients during the emergency period;
  • Extending appeals deadlines, postponing Medicare audits, and defering overpayment recoupment so that DMEPOS providers and suppliers can focus on caring for patients and provide meaningful products and services to impacted patients;
  • Adding select codes for negative pressure wound therapy (NPWT) using disposable, non-durable medical equipment to the eligible telehealth list.

See Coalition Comment
June 26, 2020
Following a February 2020 comment letter to CMS requesting that  a Hospital Harm - Pressure Injury electronic clinical quality measure (eCQM) be included in the CY 2021 Inpatient Prospective Payment System rulemaking, the Coalition sent a June follow-on communique to the Agency noting "While this measure was included in the proposed CY 2020 rulemaking, it was not included in the final CY 2020 Inpatient PPS rule nor was it included in the recent CY 2021 proposed rule.  We are disappointed that the Agency did not include these measures and hope that the Agency reconsiders placing it into the CY 2021 final rule or at the very least propose its inclusion in the CY 2022 proposed rule."

See Coalition Comment

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