Submitted Comments
January 18, 2023
The Alliance informed CMS that it does not support the packaging of skin substitutes in the physician office, as recent experience shows that packing has not worked well for patients or for hospital outpatient departments. In addition to significant flaws in the current payment methodology, there have been issues with patient access to care as well as limiting clinician’s choice of product. "We really need to have more information from the Agency on CMS’s intent, goals or criteria for packaging skin substitutes in the physician office," the Alliance said as part of oral testimony offered at CMS' Skin Substitutes Town Hall convened to collect stakeholder feedback related to changes in payment and terminology of skin substitute products being considered under the Physician Fee Schedule. The Alliance recommended that CMS develop and put forward a policy "Framework Document" for stakeholder input prior to initiating rulemaking. In the meantime, the Alliance urged CMS to continue its longstanding policy of recognizing and providing separate payment for CTPs products under the ASP methodology. Savings could be realized, the Alliance told CMS, if all skin substitute companies to submit ASP pricing to the Agency and all companies’ ASP data are published in the ASP data file.
January 3, 2023
The Alliance submitted comments to the final 2023 Medicare Hospital Outpatient PPS rule, questioning why CMS again failed to adopt the recommendations of its Hospital Outpatient Payment Panel related to skin substitutes (CTPs) and emphasizing flaws in the Agency's rationales. In 2021 and 2022, the HOPPs panel endorsed the Alliance’s policy update recommendations to enable provider-based departments to (1) be reimbursed for an adequate amount of CTP products for larger wounds so that they do not need to absorb the cost themselves or refer patients out, and (2) to equalize the payment for CTP application for wounds/ulcers of the same size no matter the anatomic location. Yet these have not been included in the HOPPS rule. "Over the nine plus years that CMS has proposed and implemented packaging for skin substitutes, the Alliance has submitted substantive data to CMS showing that the data used and the conclusions that CMS has made as it relates to the rate setting for CTPs is flawed...CMS erroneously believes that facilities are making significant profit on skin substitutes which is perpetuating the flawed logic. As a result of this flawed logic, CMS is making decisions not in the best interest in Medicare beneficiaries who are patients with wounds/ulcers," the Alliance wrote, urging the Agency to adopt the Panel recommendations related to skin substitutes in the next round of rulemaking. See full comments below.
December 5, 2022
The Alliance joined nearly 100 medical societies and clinical associations in co-signing a letter to Congress strongly urge Congressional action to prevent the 4.5% reduction to Medicare payment rates from being implemented on January 1, 2023. The letter emphasized: "Since the Medicare Physician Fee Schedule is the only payment system within Medicare lacking an annual inflationary update, clinicians, many of whom are small business owners, contend with a wide range of shifting economic factors — such as staff salaries, building rent, and purchase of essential technology — when determining their ability to provide care to Medicare beneficiaries. We cannot overstate the importance of Congress stopping the entirety of the upcoming 4.5% reduction. Anything less will result in an across-the-board cut that will further exacerbate the significant financial hardship clinicians are already facing and undermine Medicare’s ability to deliver on its promises to seniors and future generations."
November 29, 2022
The Alliance provided comments to CMS' Request for Information; National Directory of Healthcare Providers & Services requesting that wound care and/or wound management services be identified within the directory. "The Alliance is supportive of a National Directory but is concerned that CMS will only list providers with recognized specialties. The practice of wound care is not limited to one particular medical specialty. Instead, there are many different specialists who treat patients with chronic wounds. These practitioners include but are not limited to the following: surgeons (e.g., general surgeons, vascular surgeons, plastic surgeons, and foot and ankle surgeons), vascular medicine physicians, physical medicine & rehabilitation physicians who often manage chronic wounds and amputees, podiatrists, dermatologists, nurses and nurse practitioners, infectious disease experts, physical therapists, registered dieticians, nutritionists, and primary care physicians who are in the full time practice of managing patients with wounds." In order to help patients find access to wound management services there should be a category created for providers that treat chronic wounds, the Alliance wrote.
November 18, 2022
Following oral testimony at CGS' public meeting on its draft LCD and accompanying LCA on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL366901), the Alliance submitted formal written comments to the Medicare Administrative Contractor to voice its many concerns with the draft policies. The policies are fraught with clinical inaccuracies, with statements and limitations in the policy not supported by clinical evidence or guidelines. Issues identified in Alliance comments include:
- Lack Of A Consistent And Accurate Definition Of A Chronic Non-Healing Ulcer
- Limitation of Number of Applications of CTPs in an Episode is Not Supported by the Clinical Literature
- CTPs Are NOT Surgical Supplies
- Concerns with Requiring Clinicians to Utilize the Smallest Package Size Available For Purchase From the Manufacturer
- Concerns with Not Allowing Clinicians to Switch CTP Products During Course of Treatment
- Incorrectly Describing the Application of CTPs as an Adjunct Therapy Rather than an Advanced Therapy
Concerned about the implications these policies will have on patient care and access, the Alliance recommended that CGS pull the draft policies, then work with stakeholders and its Contractor Advisory Committee (CAC) to craft a more accurate and well-balanced policy.
- Lack Of A Consistent And Accurate Definition Of A Chronic Non-Healing Ulcer
- Limitation of Number of Applications of CTPs in an Episode is Not Supported by the Clinical Literature
- CTPs Are NOT Surgical Supplies
- Concerns with Requiring Clinicians to Utilize the Smallest Package Size Available For Purchase From the Manufacturer
- Concerns with Not Allowing Clinicians to Switch CTP Products During Course of Treatment
- Incorrectly Describing the Application of CTPs as an Adjunct Therapy Rather than an Advanced Therapy
Concerned about the implications these policies will have on patient care and access, the Alliance recommended that CGS pull the draft policies, then work with stakeholders and its Contractor Advisory Committee (CAC) to craft a more accurate and well-balanced policy.
November 4, 2022
The Alliance submitted feedback to CMS' Request for Information seeking public input on accessing healthcare and related challenges, understanding provider experiences, advancing health equity, and assessing the impact of waivers and flexibilities provided in response to the COVID-19 Public Health Emergency. The Alliance focused on the profound healthcare disparities in the outcome of chronic wounds – which disproportionately affect minority populations, and primarily affect persons with multiple comorbid conditions. Comments highlighted specific policy issues in the wound care space that negatively impacting access to care and offered recommendations and policy fixes to address these issues. Addressing the Agency's request for input on COVID 19 PHE Waivers and Flexibilities, the Alliance also specifically provided a wound care perspective on areas including telehealth and remote patient monitoring.
October 26, 2022
The Alliance elevated its concerns with CGS's proposed LCD/LCA on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers by providing oral testimony at the Medicare Administrative Contractors' public meeting. The Alliance emphasized its concern that a thorough evaluation and independent review of the evidence had not been undertaken by CGS, as this LCD mirrors the recently-issued Novitas and FCSO LCDs. The Alliance focused its comments on four main areas of concern.
- Many of the statements and limitations in the policy do not seem to have the scientific evidence to support them.
- Utilization parameters in the draft LCD seem arbitrary, will negatively impact patient care and are not supported in the evidence provided.
- There is conflicting/confusing information contained in the draft LCD that in some cases is clinically incorrect.
- There are significant procedural issues with the process in which the draft LCD was developed and released.
September 24, 2022
The Alliance sent a letter to Guidewell Source, the parent company of Medicare Administrative Contractors Novitas Solutions and First Coat Service Options, requesting that the two MACs withdraw their proposed LCDs on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041 and DL36377) and the accompanying Local Coverage Articles (DA54117 and DA57680). "As the parent company to both Novitas and FCSO, we are calling to your attention that statements in the draft LCDs and LCAs are contrary to wound care clinical practice guidelines and scientific research and they also violate several aspects of statutory and regulatory laws... the Alliance strongly recommends that this policy be withdrawn before it negatively impacts patient care."
September 23, 2022
When Novitas and First Coast Service Option re-issued for comment draft LCDs (DL35041 / DL36377) and LCAs (DA54117 / DA57680), the Alliance questioned why little previously-provided stakeholder input was reflected in the re-posted policies. “We identified many issues in our oral testimony given at April and August 2022 public meetings and in our extensive comments dated May 27. Therefore, it is baffling that First Coast and Novitas have reissued the same draft policies – without taking into consideration ANY of our or other stakeholders’ comments,” the Alliance wrote in its most recent comments submitted to the MACs in September The Alliance again took issue with the shift of 40+ products from the covered to non-covered list, flagged numerous clinical inaccuracies, and recommended that the MACSs withdraw these draft LCD/LCAs and work with their Carrier Advisory Committees (CACs) and stakeholders to craft a more accurate policy.
September 13, 2022
The Alliance submitted comments to CMS' proposed CY 2023 Hospital Outpatient Prospective Payment System expressing significant concerns with several provisions within the "skin substitute" section of the proposed rule. In its detailed feedback to CMS, the Alliance:
- Opposed CMS' renaming the term "skin substitutes" to "wound care management products."
- Opposed CMS' proposal to change CTP's HCPCS codes from “Q” codes to “A” codes (supply codes). Called out some of the concerning cross-over issues from the proposed 2023 Physician Fee Schedule and recommended that the Agency publish ASPs and continue to accept ASP pricing for inclusion in payment methodology for all CTPs in order to achieve savings and consistency.
- Urged CMS to remove patient access barriers by correcting inadequacies in CTP payments. The Alliance once again submitted the recommendation that CMS make policy updates to (1) Enable Provider-Based Departments to be reimbursed for an adequate amount of CTP products for larger wounds and (2) Equalize payment for the application of CTPs wounds of the same size, no matter where they are on the body.
