Submitted Comments

Items Related to CTPs/(skin substitutes)

March 8, 2019

Comments to AHRQ Technology Assessment on Skin Substitutes for Treating Chronic Wounds

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.

READ ALLIANCE COMMENTS
February 17, 2019

Letter to Noridian Requesting Withdrawal of Local Coverage Articles on Medicare Coverage of "Amniotic Membrane-Derived Skin Substitutes” 

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

December 14, 2018

Comments to Noridian coverage article “Use of Amniotic Membrane Derived Skin Substitutes”

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.

Read Comments
Read Noridian'S  e-mail response
September 24, 2018

Comments to CMS CY 2019 Hospital Outpatient Prospective Payment System

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

Read Alliance Comments    Attachment A to comments       Attachment B to comments
September 21, 2018

Comments to United Healthcare "Skin and Soft Tissue Substitutes" Policy

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.”

Read United Healthcare's Response 
Read Alliance Comment
September 11, 2017

Comments on the proposed CY 2018 Hospital Outpatient Prospective Payment System

The Alliance submitted comments to CMS addressing the proposed CY2018 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and quality reporting programs. Comments focused on issues with the methodology for packaging of skin substitutes (Cellular and/or Tissue Based Product for Skin Wounds, or CTPs). In response to CMS’s request for information on flexibility and efficiency opportunities to increase care, reduce costs and reduce burdens for clinicians and patients, the Alliance asked the agency to consider reform of the process it uses to assign new Healthcare Common Procedure Coding System (HCPCS) Level II billing codes to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). 
View Alliance Comment
September 6, 2016

Comments to CMS regarding the CY2017 Hospital Outpatient Prospective Payment System

The Alliance submitted comments to CMS on the CY 2017 Hospital Outpatient Prospective Payment System noting that no measures in the Hospital Outpatient Quality Reporting program are specific to wound care. The Alliance reminded CMS that there are 21 quality measures specific to the practice of wound care, fully programmed, as electronic clinical quality measures available within the U.S. Wound Registry Qualified Clinical Data Registry. Furthermore the Alliance expressed concerns on the flawed methodology CMS uses to calculate the payment for cellular and tissue-based products for wounds (CTPs, referred to in the policy as skin substitutes).
View Alliance Comment 
August 8, 2016

Comments to Cigna Government Services Local Coverage Determination (LCD) for Application of Skin Substitute for Wounds of Lower Extremities (DL36690)

The Alliance submitted comments to Cigna Government Services (CGS) on Local Coverage Determination (LCD) for Application of Skin Substitute for Wounds of Lower Extremities (DL36690). The Alliance reminded CGS that the term “skin substitutes” is clinically inaccurate and should be replaced with more inclusive descriptor “Cellular and/or tissue based products for wounds (CTPs).” The comments addressed issues in the draft policy related to the classification of products, utilization instructions, coverage limitations and confusing language in the guidance regarding its distinction when providing coverage for diabetic foot ulcer (DFU) vs. venous leg ulcer (VLU). Comments also highlighted the need for CGS to recognize podiatrists as providers who can and do treat patients with wounds, and the indications for use (IFUs) for products affected by the LCD. 
View Alliance Comment
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