Submitted 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. See the Alliance's full comments to CMS below.

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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:
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."

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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.
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.

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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. Until AHRQ reviews real world evidence for CTPs, the Alliance believes that this TA is incomplete," concluded the Alliance in its submitted comments.

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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.

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December 14, 2018
The Alliance submitted a letter to Noridian in response to its coverage article published on November 8, 2018 entitled “Use of Amniotic Membrane-Derived Skin Substitutes” (A56155) and (A56156). The article stated that Noridian had determined that the clinical use of amniotic membrane-derived skin substitutes outside of the care of DFU and VSU as not reasonable and necessary and non-covered. The Alliance noted concerns that Noridian’s actions disrupt the care being provided to many Medicare beneficiaries, and questioned whether Noridian had authority to create Medicare coverage restrictions under the guise of an "article" that is not subject to public notice and comment.

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October 4, 2018
Via email, the Alliance requested clarification from WPS regarding its new A55909: Wound Care Coding Companion for Wound Care L37228. The Alliance requested the literature that WPS reviewed to eliminate coverage of specific codes related to debridement, noting that the 21st Century Cures Act requires MACs to provide the evidence utilized in making coverage decisions or eliminating coverage.

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September 24, 2018
The Alliance submitted comments to CMS in response to its proposed CY 2019 Hospital Outpatient Prospective Payment System (PPS) and Ambulatory Surgical Center Payment Systems as well as changes to the Quality Reporting Programs. The Alliance focused its comments on provisions related to:
    • CTP packaging and payment methodology
    • Pass through status for CTPs
    • Guidelines
    • Methods to control unnecessary increases in the volume of outpatient services
    • Ways to control unnecessary costs
    • Price transparency

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