Submitted Comments

September 5, 2023
Via submitted comments and testimony to CMS’ Advisory Panel on Hospital Outpatient Payment, the Alliance submitted five recommendations to correct inadequacies in payments for CTPs ("skin substitutes") and remove barriers to access. If accepted and implemented by CMS in upcoming Hospital Outpatient Prospective Payment System updates, these recommendations would positively impact wound care by correcting flaws in the payment that have negatively impacted reimbursement for CTPs and removing barriers to access for these important wound care products. The recommendations were overwhelmingly approved by the Panel and elevated in its  report to CMS:
  1. Assign the existing CPT® add-on codes (15272, 15276, 15274, 15278) and HCPCS codes (C5272, C5276, C5274, C5278) to appropriate APC groups allowing for separate payment and issue an exception to separately pay for these add-on codes.
  2. Assign the CPT and HCPCS codes for the same size wound, regardless of anatomical location on the body, to the same APC groups.
  3. Assign all new CTPs with both Q and A HCPCS codes, to the low-cost APC groups until a manufacturer provides cost information to CMS.
  4. Realign both the high-cost and low-cost application procedure codes to higher paying APC groups that reflect the current average sales prices of all CTPs. Consistently publish and use the ASP of all CTPs.
  5. Don’t assign CTPs that are not in sheet form (e.g., gel, powder, ointment, foam, liquid, or injected) to any APC group because these products are not allowed to use the current application codes of 15271-15278 or C5271-C5278, which drives the APC group assignment.

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August 30, 2023
Submitted “Request for Immediate Response” letters to Novitas, FCSO & CGS medical directors regarding their LCDs/LCAs on CTPs (skin substitutes) for the treatment of diabetic foot ulcers/venous leg ulcers that were issued as final with substantive new provisions that were not contained in the draft issued for comment, that failed to reflect stakeholder comments, and that contained arbitrary utilization parameters and other restrictive provisions that created significant barriers to quality patient care. The letters flagged numberous clinical issues and procedural process concerns as well as included a detailed collection of Alliance members’ clinical and operational questions in need of clarity.

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August 29, 2023
The Alliance submitted comments to CMS's proposed 2024 Home Health Prospective Payment System Rate Update, with a focus on provisions related to the scope of the benefit and payment for lymphedema compression treatment items. The Alliance recommended inclusion a mechanism to allow for fair payment to health professionals on the time used for measurement, fitting and training around clinical compression garments, bandages, and accessories. Alliance comments also addressed provisions that include home health quality reporting program and wound care. 

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August 24, 2023
The Alliance sent a second letter to Guidewell Source, the parent company of Medicare Administrative Contractors Novitas Solutions and First Coat Service Options, reminding Guidewell's CEO and General Counsel to the negative patient care implications of the final LCDs/LCAs on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The letter, also sent to Novitas and FCSO, highlighted the detailed list of operational questions in need of clarity, and requested that the MACs withdraw these coverage policies and develop new ones that is more clinically accurate and reflective of wound care community-wide stakeholder input.

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August 21, 2023
The Alliance submitted comments CMS on its proposed outline of a new Transitional Coverage of Emerging Technologies (TCET) pathway for certain devices designated as “breakthrough” by the FDA. While the Alliance applauds efforts by CMS bring medically necessary and valuable products to market faster, the proposal does not go far enough, the Alliance told CMS. "This proposal contains a lengthy evidence development process without a predictable or transparent coverage pathway – which was purportedly the purpose of the TCET being issued. There is no accountability being placed on the Agency to ensure the process is speedy and timeframes for review are met." Read more,

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July 28, 2023
The Alliance signed on to a letter with 20+ other health/medial associations to the Centers for Medicare and Medicaid Innovation (CMMI) requesting an extension to comment on its Request for Information seeking stakeholder input regarding the design of future episode-based payment models. The RFI was published on July 18 - just days after the draft 2024 Medicare Physician Fee Schedule and Outpatient Prospective Payment System proposed rules were released for comment.
The RFI required comments within 30 days for this large and important payment issue – which we and others did not feel was sufficient time to vet within our various memberships to consolidate and provide substantive feedback. CMMI said it could not extend comment period but will provide additional opportunities to comment in rulemaking. In issuing the RFI, CMS is looking to address the inefficiencies in traditional Medicare fee-for-service, where providers are paid for each item or service, which may drive volume over value and fragment care. CMS indicated that the Innovation Center intends to design, implement, and evaluate future episode-based payment models with a focus on five strategic objectives, including advancing health equity and driving accountable care.

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July 24, 2023
The Alliance submitted comments to the FDA on its "Decentralized Clinical Trials for Drugs, Biological Products and Devices: Draft Guidance for Industry, Investigators and Other Stakeholders."  Overall supporting the guidance and its intent to expand access to diverse locations/populations, the Alliance raised several areas of concern surrounding whether the policy would have the impact that the Agency is striving to achieve. Our comments offer a series of recommendations, as well as highlight specific provisions that would benefit from additional clarity. 

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June 21, 2023
Together with 30+ clinical organizations in cardiology, podiatry and diabetology, the Alliance co-signed a letter to Congress supporting the Amputation Reduction and Compassion Act of 2023. Each year, more than 150,000 amputations are performed in the US to remove toes, legs or feet affected by advanced peripheral artery disease (PAD). This legislation would help reduce these preventable amputations by requiring Medicare, Medicaid, and plans sold on the federal healthcare exchanges to fully cover screening tests for beneficiaries who are at-risk of PAD. Early diagnosis and intervention can restore blood flow to affected limbs and reduce the risk of amputation. Originally introduced in 2021 (see full text) and reintroduced in June 2023, this legislation includes provisions to:
  • Increase access to diagnostics aimed at identifying conditions that can lead to amputation by providing coverage for PAD screenings of at-risk beneficiaries in Medicare and Medicaid;
  • Require the development of quality metrics among payers and facilities that can prevent amputations; and
  • Provide access to amputation prevention services through the development of a voluntary pilot program, including through patient risk medication and management approaches, early screening and detection, ongoing surveillance, testing, and more.
See letter below. 

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June 20, 2023
Together with 150+ organizations spanning health, technology, aging and more, the Alliance voiced its support for the CONNECT for Health Act of 2023. Last introduced in 2021 and re-introduced in June 2023, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act would expand coverage of telehealth services through Medicare, make permanent COVID-19 telehealth flexibilities, and make it easier for patients to connect with their doctors. Specifically, the legislation would:
  • Remove geographic restrictions on telehealth services and expand originating sites to include the home and other sites;
  • Allow health centers and rural health clinics to provide telehealth services;
  • Allow more eligible health care professionals to utilize telehealth services;
  • Remove unnecessary in-person visit requirement for telehealth services supporting mental health; and
  • Require more published data to learn more about how telehealth is being used, impacts of quality of care, and how it can be improved to support patients and health care providers.

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May 26, 2023
Together with the Clinical Labor Coalition, the Alliance submitted a letter to Congress in support of the recently-introduced legislation, the “Providing Relief and Stability for Medicare Patients Act of 2023” (H.R. 3674). This legislation would help mitigate cuts to office-based specialists for a targeted group of services for two years, thereby helping to avoid significant disruptions in patient access to care. "As you are aware, the discrepancy between what it costs to run a physician practice and actual payment combined with the administrative and financial burden of participating in Medicare is incentivizing market consolidation. We are concerned that the ongoing severity of recent cuts, combined with additional anticipated payment adjustments, will result in a breaking point for many physicians. Absent additional Congressional intervention via passage of H.R. 3674, the result will be more providers leaving the field, more practices being closed or sold, and a significant number of patients losing access to a variety of healthcare service in their communities."

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