Submitted Comments

October 14, 2019

The Alliance submitted comments to the United States Pharmacopeia's  (USP) draft Medicare Model Guidelines advocating for creation of a new subcategory for wound care products. Under the current policy, wound care products are in the “Dermatological, Other” category that includes a long list of products for a variety of conditions with varying severity, such as acne and lice treatments. The Alliance requested that the USP add a subcategory titled “wound care” under Dermatology to distinguish the chronic wound products from other subcategories in Dermatology, which would also better protect coverage of wound care products under Medicare Part D.

Read Alliance comments
September 27, 2019
The Alliance submitted comments to CMS addressing relevant wound care provisions in its CY2020 Hospital Outpatient Prospective Payment System. Comments flagged concerns and provided recommendations on a range of topics including:
  • The broad sweep to move all therapeutic services from direct to general supervision
  • The implementation of prior authorization for procedures that are often utilized to treat chronic wounds that threaten both life and limb
  • Payment methodologies for CTPs
  • Lump-sum episode based payment for a wound care episode
  • The single Ambulatory Payment Classification (APC) proposal and C-APC methodologies 
  • Inaccurate APC Group assignments for CTPs due to facilities' incorrect coding/billing, which for years has resulted in APC Group assignments that fail to reflect the true costs of the CTPs.

September 27, 2019

The Alliance submitted detailed comments to CMS on a range of provisions in the proposed Physician Fee Schedule that impact wound care providers. Comments focused on:

  • Evaluation and Management Codes
  • The conclusions of three RAND Corporation reports utilized in the report to support certain provisions (CMS had contracted RAND to collect data on the number and level of post-operative visits for surgical global codes provided to Medicare beneficiaries)
  • Relative Value Units (RVUs) for Physical Therapy
  • Practice Expense (PE) RVUs for Disposable Negative Pressure Wound Therapy (CPT Codes 97607 & 97608)
  • Open Wound Debridement (CPT Codes 97597 and 97598)
  • Ultrasonic Wound Assessment (CPT Code 97610)
  • The process of removing measures from the MIPs for being “topped out”

Read Alliance comments
September 9, 2019

The Alliance submitted comments to CMS in response to the proposed updates in the CY 2020 Home Health Prospective Payment System. The Alliance noted concern with CMS’ proposal to reduce the Requests for Anticipated Payment (RAP), asking that CMS consider the cash flow requirements of new home health agencies who also have capitalization needs and smaller agencies and those in rural areas have a significant need for cash flow support. The Alliance also strongly opposed the removal of pain measures from the Home Health Quality Reporting Program (HH QRP) and the Home Health Consumer Assessment of Healthcare Providers and Systems (HHCAHPS surveys). While CMS reports that elimination of the measure is in line with the agency’s broader efforts to address the opioid epidemic, the Alliance flagged that pain remains an issue that is important to patients served in the home health setting  and there is no evidence to suggest that the use of these measure is linked to opioid misuse.


August 12, 2019

The Alliance submitted comments to CMS in response to its Request for Information regarding Patients Over Paperwork related to reporting and documentation requirements, coding and documentation requirements for Medicare or Medicaid payments, and prior authorization procedures. Our comments focused on several key issues, including:

  • NCCI edits
  • HCPCS coding reform
  • Local coverage decisions (LCDs) versus coverage articles (LCAs)
  • Prior authorization
  • Billing for disposable negative pressure wound therapy in home health care setting
  • Implementation timing of rules issued by CMS

Read Alliance Comment
July 23, 2019

The Alliance submitted comments to AHRQ regarding its draft Technical Brief (TB) and Supplemental Evidence and Data for Systematic Reviews (SEADS) report on “Skin Substitutes for Treating Chronic Wounds.” Comments summarized the problematic procedural issues surrounding the report and raised concern that only 3 of the 83 studies submitted were accepted for consideration - excluding of most of the evidence submitted from the expanded evidence search that had deliberately been re-opened. "Stakeholders have the right to review the next version of the draft to ensure that the corrections were made, the evidence was utilized correctly and read whether any conclusions were altered as a result," emphasized the Alliance. "We urge AHRQ to release the next draft of the technical review with an additional public comment period prior to final publication."
Read Alliance Comment


July 21, 2019
The Alliance responded to AHRQ's request for information on "The Impact and Use of Evidence-Based Practice Center (EPC) Evidence Reviews." Our comments noted that AHRQ reviews in the wound care space tend to be "myopic", with significant errors and with key questions that are too narrowly focused to impact coverage.  We provided suggestions to AHRQ on how the evidence reviews can be more useful and impactful to the wound care space, including: Require key investigators to actually practice in the area of the report; Conduct assessments/reviews  independent of coverage or payment; and, Utilize real-world data/evidence and/or registry data when reviewing chronic wound care issues.
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March 11, 2019

The Alliance attended the March 11 Physician-Focused Payment Model Technical Advisory Committee (PTAC) meeting and provided comments on the PTAC proposal regarding “Bundled Payment for All Inclusive Outpatient Wound Care Services in Non Hospital Based Setting.” The Alliance complimented the PTAC’s Preliminary Review Team (PRT) on the very extensive background work that they did in preparation for this meeting. The Alliance was in agreement with the PTAC’s preliminary results that the proposal as written has a number of structural flaws and elements that were not sufficiently developed and thus should not move forward as it is currently written.

Read Alliance Comment

March 8, 2019
The Alliance submitted comprehensive comments to the AHRQ Draft Technology Assessment (TA) Report on “Skin Substitutes for Treating Chronic Wounds.”  Comments focused on a broad range of issues in the document, including the "Guiding Questions" that framed the document, the "Risk of Bias" section, the conclusions reached, and the pervasive use of the term "skin substitute" instead of Cellular and/or Tissue-Based Products (CTPs). "There was recognition by the AHRQ that real world evidence would be beneficial.  Yet, AHRQ either eliminated or did not review any studies which would provide real world data and help to answer some of the questions posed in this TA.  Until AHRQ reviews real world evidence for CTPs, the Alliance believes that this TA is incomplete," concluded the Alliance in its submitted comments.

February 17, 2019

Following initial comments (Dec. 2018) addressing Noridian’s local coverage articles A56155 and A56156 on "Amniotic Membrane-Derived Skin Substitutes” and an initial response from Noridian, the Alliance sent a follow-on letter in February 2019. The letter requests withdrawal of the policy and outlines why ithe Alliance believes that Noridian followed improper procedure. “The Coverage Articles made substantive changes to reduce Medicare coverage but did not follow CMS’s rules for changing coverage and are not a substitute for an LCD. They improperly attempt to achieve the same goal as an LCD because they state comprehensively that the use of amniotic membrane derived skin substitutes for treatment of any condition other than a DSU or VSU is 'not reasonable and necessary and non-covered.' These Coverage Articles also are not a clarification of an existing policy or CMS regulation already in effect, as is the case with other Coverage Articles. Rather, the Coverage Articles created a new substantive standard for Medicare coverage."

The Alliance will be meeting with Noridian in March to further discuss this issue.

Read Alliance Letter

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