Submitted Comments

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.

READ ALLIANCE 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

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.

Read Comments
Read Noridian'S  e-mail response
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. 

Read Alliance emaiL

 

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

Read Alliance Comments    Attachment A to comments       Attachment B to comments
September 21, 2018
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 10, 2018
The Alliance submitted comments to CMS' proposed CY 2019 Physician Fee Schedule supporting specific provisions to ease paperwork/documentation burdens, including:
  • Changing the required documentation of the patient’s history to focus only on the interval history since the previous visit; 
  • Eliminating the requirement for physicians to re-document information that has already been documented in the patient’s record by practice staff or by the patient; 
  • Allowing physicians to choose between current documentation guidelines, documenting by time only, or documenting by medical decision making only; 
  • Removing the need to justify providing a home visit instead of an office visit. 
However,  the Alliance also used its comments to voice its strong opposition to the consolidation of Evaluation and Management codes and the corresponding reduction in payment for E/M services for those that provide the most complex care. The Alliance submitted a series of examples of unintended consequences that the proposal would create and urged CMS not to move forward with that provision. 
Read Alliance Comment
August 7, 2018
The Alliance submitted comments addressing the AmeriHealth Caritas Clinical Policy on Full-body Hyperbaric Oxygen Therapy (HBO2). While supportive of the need for safe and effective HBO2 and the need for policies that minimize administrative burdens while still being easy to implement and enforce, the Alliance identified clinically inaccurate and/or unsubstantiated information within the policy to be addressed as the policy is revised.

Read the Alliance comment.
August 3, 2018
The Alliance submitted a letter to Congress supporting the Lymphedema Treatment Act (S. 498, H.R. 930). The Alliance recommended that Congress grant CMS the statutory authority to cover compression bandages and garments for lymphedema under the Medicare benefit, noting that this change could have a substantial impact via improved outcomes and quality of life, reduced costs for beneficiaries and the health care system, and decreased federal spending. 

Read Alliance comment.
July 22, 2018
The Alliance submitted comments to CMS in response to its request for comments on “Pre-Claim Review Demonstration for Home Health Services.” While the Alliance understands that the rationale for bringing this failed demonstration project back is to address issues of fraud and abuse, we noted in comments that the policy would create a significant administrative burden on home health agencies. Most concerningly, it would have a tremendous negative impact on the access to care for beneficiaries in order for CMS to target a few “bad apples.”

Read Alliance comment. 
logo
Email: marcia@woundcarestakeholders.org
Phone: 301.530.7846
Fax: 301.530.7946
5225 Pooks Hill Road
Suite 627 South
Bethesda, Maryland 20814
Follow us on:
linkedin