Submitted Comments

Items Related to CTPs/(skin substitutes)

October 16, 2020

Alliance Opposes Payment Cuts for Physician & Physical Therapy Services in CMS’ Proposed CY2021 Physician Fee Schedule

October 2020 – In comments submitted to the Center for Medicare and Medicaid Services (CMS), the Alliance of Wound Care Stakeholders voiced its opposition to payment cuts from five to nine percent for surgical procedures and nine percent for physical therapy services as CMS proposes in its CY2021 Physician Fee Schedule. The Alliance also called on CMS to (1) Adopt all of the American Medical Association’s RUC recommendations including updated E/M values in procedure codes with 10- and 90-day global periods; (2) Maintain a patient’s home as an originating site even when the public health emergency expires; (3) Include additional telehealth codes for physical therapy services, and more.

Additionally, in comments submitted to CMS' CY2021 Hospital Outpatient Prospective Payment System proposed updates, the Alliance flagged concerns with provisions dealing with coding and payment for Cellular and/or Tissue based Products for skin wounds (CTPs, also known as skin substitutes). The Alliance supported inclusion of synthetic CTPs in the definition of “skin substitutes” but expressed significant concerns with the Agency’s proposed establishment of a unique C code to define an entire class of non-branded products and the placement of these products in the OPPS high cost payment package.
See Alliance News Update Summarizing Comments

October 2, 2020

Comments to CMS Proposed CY2021 Hospital Outpatient Prospective Payment System

The Alliance submitted comments to CMS’s proposed CY2021 Hospital Outpatient Prospective Payment System. Our comments:

  • Encouraged use of the “Cellular and/or Tissue Based Products for Wounds “(CTPs)  terminology in policymaking, in place the currently used “skin substitutes.”
  • Supported inclusion of Synthetic CTPs in the definition of “skin substitutes” but expressed significant concerns with the Agency’s proposed establishment of the code C1849 (“Skin substitute, synthetic, resorbable skin substitute per square centimeter) to define an entire class of non- branded products and its placement in the OPPS high cost payment package. The Alliance reviewed the impacts of this code as proposed and submitted a number of alternative recommendations.  
  • Requested that Hyperbaric Oxygen Therapy be added to the list of services that require direct supervision
  • Sought clarification on how provider based departments should make decisions on the level of service assigned to code G0463 (hospital outpatient clinic visit) once the new 2021 E/M guidelines are in place.
August 14, 2020

Comments to CMS Advisory Panel on Hospital Outpatient Payment

The Alliance provided written and oral comments to CMS' August 2020 CMS Advisory Panel on Hospital Outpatient Payment. Comments focused on provisions related to "synthetic skin substitutes" and included recommendations to:
  • Eliminate the new code C1849 – synthetic skin substitutes resorbable and require any synthetic skin substitute to apply for an appropriate HCPCS Q code to be considered a “skin substitute.”
  • Remove placement of the C1849 synthetic skin substitute products from the high cost tier.
  • Change the current “skin substitute” terminology to “cellular and or tissue based products for skin wounds."
Read Alliance comments
August 11, 2020

Co-Signed Letter to the Senate Finance Committee

The Alliance co-signed a letter to the Senate Finance Committee expressing concern regarding legislation (S. 4295) that would allow Health and Human Services to extend the period of Medicare pass-through status in the hospital outpatient setting to any product with that status during the COVID public health emergency. As written, the proposed legislation would allow products that have already had well over the statutory period of two-to-three years to have extended pass-through time – in some cases, more than double the statutory limit. The letter focused on the impact such a pass-through extension would have on CTPs and noted the importance of ensuring access to all CTP products in the market to support clinical choice and patient value. “Extending the pass-through term of CTP products well beyond the normal pass-through period drastically detracts from that effort. We believe this skews patient access as it incentivizes use of these CTP pass- through products over others in an otherwise established market,” the letter stated.
Read Co-Signed Letter
June 4, 2020

Letter to MACs addressing payment policies for home care, assisted living and nursing homes

The Alliance submitted a letter to three Medicare Administrative Contractors (MACs) addressing payment policies for services provided in the home (POS 12), assisted living facilities (POS 13), and nursing facilities (POS 32). In comment to Palmetto, National Government Services (NGS) and Wisconsin Physician Services (WPS), the Alliance suggested that for practitioners providing wound care  in these sites, application of cellular and/or tissue products for skin wounds (CTPs) and disposable negative pressure wound therapy services be paid at the applicable Medicare physician non-facility rate. "We submit that Policy Manual provisions along with the waivers that have been issued support our request…We are concerned that [MACs] have not been covering these services in these settings, even though there is a dire need to provide care to these patients.  Enabling payment of these proven wound care therapies (already covered by Medicare) would allow access to care while reducing the risk of COVID transmission for vulnerable wound care beneficiaries," the Alliance wrote. 
Letter to Palmetto
Letter to NGS
Letter to WPS
May 29, 2020

Comments to CMS COVID-19 Public Health Emergency Interim Final Rule

The Alliance has continued our proactive wound care advocacy with CMS surrounding the waivers and flexibilities implemented in policies addressing medical care amid the COVID-19 crisis. In comments to CMS's Interim Final Rule, the Alliance supported the Agency’s implementation of many policies while also pursuing clarification on several specific provisions that we'd flagged in our April 6th letterto the Agency that still have not been addressed. These included advocacy on issues related to surgical dressing benefits, negative pressure wound therapy billing, CTP co-pays, reimbursement and increased access for alternative methods of debridement, documentation requirements,  and more. The Alliance provided specific policy recommendations and requested that CMS add to its series of upcoming "Office Hours" teleconferences a call specific to wound care as well as one for DME suppliers/providers and manufacturers of medical equipment.
Read Alliance comments
March 31, 2020

Letter to CMS regarding CTP Payment Methodology Definitions

The Alliance submitted recommendations  regarding payment methodologies for cellular and/or tissue based products for skin wounds (CTPs) for the Agency to consider prior issuing proposed rulemaking for Calendar Year 2021. The Alliance highlighted that there are many differing interpretations of the three payment methodologies that CMS has been considering: Episodic Payment, Single APC, and Comprehensive APC. The Alliance outlined its  understanding of each methodology, and sought to clarify if its definitions and interpretations were correct. "Once we come to an understanding of the definitions, we can better offer our specific recommendation," the Alliance informed CMS. 

February 3, 2020

Comments to Texas Medicaid Draft Policy on Wound Care Management Services

In written comments, the Alliance alerted Texas Medicaid to the many provisions within its Draft Policy on Wound Care Management Services that are out of date with current standards of good wound care practice. Comments addressed policy provisions surrounding CTPs, negative pressure wound therapy (NPWT and dNPWT), surgical dressings, debridement, documentation, prior authorization and more, and included specific recommendations to update the policy as it moves from draft to final. 
Read Alliance Comments

July 23, 2019

Comments to AHRQ Draft Technical Brief on “Skin Substitutes for Treating Chronic Wounds”

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


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.

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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