Submitted Comments

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.

• CTPs/(skin substitutes)
• ARHQ

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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.

• CTPs/(skin substitutes)
• LCDs
• Medicare Administrative Contractors (MACs)

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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.

• CTPs/(skin substitutes)
• LCDs

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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.

• Debridement
• DMEMACs
• LCDs

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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

• CMS
• CTPs/(skin substitutes)
• Prospective Payment System (PPS)
• HOPPS

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The Alliance submitted a letter to United Healthcare, requesting that it delay implementation of “Commercial Medical Policy 2018T0592A, Skin and Soft Tissue Substitutes. ” The policy, which is scheduled to become effective October 1, 2018, will “cause significant disruption in the care of your members in outpatient, hospital, rehabilitation, skilled nursing and other settings who are currently receiving skin and soft tissue substitutes for the management of their chronic wounds,” the Alliance wrote.  “We request a meeting with you to discuss our concerns, address issues regarding improvement in health outcomes with these therapies, and to offer recommendations that will serve to improve the clinical outcomes for your member patients at lower cost of care.”

• CTPs/(skin substitutes)

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