Submitted Comments
March 6, 2023
The Alliance submitted comments to CMS proposed rule on Advancing Interoperability and Improving Prior Authorization (PA) Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies. While the Alliance is supportive of the Agency’s proposal to streamline PA process, we expressed concern about the lack of provisions addressing payer accountability. "Payers need to be held accountable or the changes proposed will have little effect," the Alliance wrote. For example, in the proposal, CMS states that if a provider does not hear back from the payer in the timeframe proposed then the provider "should contact the payer." This certainly does not streamline the burden on providers, the Alliance noted, and does not hold payers accountable for their lack of response. The Alliance encouraged CMS to include payer accountability provisions as this proposal moves towards finalization.
February 10, 2023
The Alliance submitted comments to the director and deputy director of CMS' Hospital and Ambulatory Policy Group to augment oral comments shared at the Agency's January 2023 Skin Substitute Town Hall. "Any efforts by the Agency that will curtail access to CTPs will have a direct impact on infection and amputation rates," wrote the Alliance, noting that CMS "has failed to provide any assessment of this impact or details about its rationale for the change such as: an impact analysis, details on how CMS will implement bundling in the physician office setting, the criteria used for setting the rates, or the reasons for making this seismic change. Moreover, the Agency has not demonstrated that the bundling of these products will not impact access to these products, especially to our greatly underserved Medicare patient populations who suffer disproportionately." The Alliance included a list of detailed questions for the Agency to address and suggested that CMS develop a framework document where such questions could be answered - and vetted with stakeholders - prior to any new rulemaking taking place.
January 23, 2023
The Alliance, together with 100+ clinical and medical professional society organizations representing more than one million healthcare providers, co-signed a letter to the new 118th Congress urging "comprehensive, transformative reforms" to the Medicare payment system over the next several years. The letter points to declining Medicare payments and the lack of an annual inflationary update in the Physician Fee Schedule, even though clinicians — many of whom are small business owners — contend with a wide range of shifting economic factors. "Year-over-year cuts, combined with a paucity of available alternative payment/value-based care models, clearly demonstrate that the Medicare payment system is broken...Reform is imperative to sustaining medical practices and ensuring a robust workforce to care for the growing number of America’s seniors. We again ask Congress to work with us on long-term, substantive payment reforms and urge Congressional hearings as soon as possible."
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.
