Submitted Comments

The Alliance submitted comments to CGS Administrators proposed LCD “Non-Invasive Vascular Studies" (DL34045), flagging areas of the policy that are not reflective of current practice or standards of care. Comments addressed a range of issues in the wording of the policy including: inconsistencies in the descriptions of providers permitted to order/perform non-invasive vascular studies, credentialing definitions, accreditation standards and documentation burdens. 

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The Alliance responded to CMS' Request for Information (RFI) issued in September to obtain stakeholder feedback  on the potential consolidation of four Medicare Administrative Contractors (MAC) jurisdictions into two jurisdictions, as well as to obtain feedback on extending MAC contracts to ten years. In its response, the Alliance emphasized the need for improved CMS oversight and transparency in MAC operations as well as provided feedback on issues spanning staffing and staff training, care disruption concerns, Contractor Advisory Committee (CAC) engagement, evidence evaluation processes, provider communications, prior authorization, appeals, reconsideration requests, and more.

• Medicare Administrative Contractors (MACs)

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As part of the CAC (Contractor Advisory Committees) Engagement Coalition, the Alliance sent a co=signed letter to CMS' Coverage and Analysis Group that identified meaningful opportunities to improve the engagement of clinicians in local Medicare policy development. The letter elevated specific recommendations regarding how MACS could work more collaboratively with Contractor Advisory Committees (CACs) and other advisory panels and addressed bringing more transparency and stakeholder input into the development of local coverage and payment policies.

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The Alliance submitted comprehensive comments to CMS’ proposed CY 2025 Hospital Outpatient Prospective Payment System (CMS-1809-P). Alliance feedback and recommendations focused on a range of provisions impacting wound care, including:

• CTPs/Skin Substitutes: The Alliance once again forwarded recommendations that CMS’s own HOPPS Advisory Panel has endorsed year after year: that CMS update provisions to (1) Enable provider-based departments to be reimbursed for CTP product for larger wounds by paying separately for select add-on codes; (2) Equalize payment for the application of CTPs on wounds/ulcers regardless of anatomic location under a consistent APC code, and (3) Place all new CTPs with "Q" or "A" HCPCS codes in low-cost APCs, unless or until a manufacturer provides CMS with cost data suggesting otherwise. The Alliance's submission to CMS flagged many deficiencies/inaccuracies in the Agency’s “response to comments” that CMS published as rationale for not adopting these previously suggested changes. The Alliance provided correction and clarity on the "response to comments"  to further advance CMS consideration of these recommended policy updates.
• Total Contact Casting (TCC): The Alliance requested that CMS again follow the endorsement of its HOPPS Advisory Panel and pay hospital outpatient departments a separate APC for the TCC (APC 5102) when a debridement or graft is performed on the same date of service – something currently denied because of an inaccurate NCCI edit that has been put in place. The Alliance re-forwarded its and the Panel's recommendation that CMS consider HCPCS code 29445 (Application of rigid total contact leg cast) a separately payable code when performed concurrently on the same date of service as select HCPCS codes related to debridement and skin substitute grafts so that facilities can be paid for this separately identifiable service that is not included in the debridement or application of CTPs, and patients can recieve this care.
• Alliance comments also addressed provisions on Blood and Blood Derived Products, Telehealth and Prior Authorization.

See the Alliance’s full comments below.

• CTPs/(skin substitutes)
• Prior Authorization
• HOPPS

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The Alliance submitted comprehensive comments to CMS’ proposed CY 2025 Medicare Physician Fee Schedule (CMS- 1807-P). Alliance comments and recommendations focused on a range of provisions impacting wound care, including:

• National payment for autologous blood-derived products (HCPCS code G0465): The policy included national pricing for this product category  but at an inadequate payment rate that would challenge clinicians’ ability offer these treatments and perpetuate access issues. The Alliance urged CMS appropriately account for the current cost and professional time and effort required to deliver these  wound care treatments. To address this the Alliance recommended that CMS:
  • Change the proposed CPT skin substitute-aligned crosswalk codes to more clinically aligned and appropriate epidermal & dermal autograft codes;
  • Include appropriate RVUs for debridement in the total RVU calculation for G0465 (or clarify that debridement can be billed separately if it is not included); and
  • Remove provisions restricting a provider from billing for more than one unit of G0465 per day so that patients with multiple foot wounds can to be treated.
• CTPs/skin substitutes for skin wounds: The Alliance urged CMS to:
  • Adopt a universal ASP reimbursement methodology for all CTPs - under both “Q” & “A” HCPCS codes;
  • Use the Agency’s full enforcement authority to ensures it receives complete ASP data from manufacturers, including discounts and rebates; and
  • Publish all ASPs for CTP products in the pricing data file, which ultimately could mitigate the concerns that are driving CMS to consider disruptive payment approaches such as bundling.
• Physician Payment Cuts: The Alliance flagged that the proposed 2.8% conversion factor reduction fails to support clinicians and encouraged CMS to work with Congress to ensure that payments to clinicians are adjusted each year with an inflationary update.
• MIPS Value Pathway: The Alliance sought CMS feedback and collaboration on the potential creation of a Chronic Wound Management MVP that could make it possible for the many different types of practitioners involved to collaborate in such a way as to properly associate quality and cost.
• Physical therapy assistant supervision: The Alliance supported the change in supervision requirement from direct to general, consistent with the standards applied in nearly all settings paid under Medicare.
• Alliance comments also addressed provisions related to caregiver training services,  telehealth, the Medicare Diabetes Prevention Program, and the global surgery package.

See the Alliance's full comments below. 

• CMS
• CTPs/(skin substitutes)
• Physician Fee Schedules
• Prospective Payment System (PPS)

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The Alliance submitted comments to CMS' proposed CY 2025 Home Health Prospective Payment System Update (CMS-1803-P) with a focus on provisions impacting wound care, including:

• Implementation issues surrounding the Lymphedema Treatment Act: The Alliance again flagged its ongoing concern that no coding and payment provisions have been put in place in  Home Health PPS provisions enacting the Lymphedema Treatment Act to ensure that qualified health professionals (“QHPs”) can get reimbursed for the measuring, fitting, and training services they provide when furnishing patients with lymphedema compression treatment item. "We request that CMS ensure payment is provided to the individuals that render these critical services, and to provide patients with meaningful options in seeking measuring and fitting services from the QHP of their choosing....Suppliers are being compensated for all of these despite not performing any of the services. This was not the intent of Congress and is impacting patient access and patient care. Compensating DME suppliers, but not QHPs, for work that QHPs are performing is an inefficient and inequitable use of Medicare dollars, disincentivizes the use of lymphedema clinician/therapists’ expertise in garment selection and diminishes patient choice in the provision of their care," the Alliance wrote. 

Alliance comments also addressed:

• Home health payment rate reductions
• Conditions of Participation (CoPs) standard
• Quality reporting: social determinants of health
• Disposable negative pressure wound therapy
• Initial and comprehensive assessments by physical therapists

• Negative Pressure Wound Therapy (NPWT)
• Prospective Payment System (PPS)
• lymphedema

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Prior to submitting detailed written comments to CMS in September, the Alliance presented its specific recommendations to relieve barriers to access of CTPs ("skin substitutes") in the hospital outpatient setting to the Agency's Advisory Panel on Hospital Outpatient Payment at its Aug. 26th public meeting. The Alliance's oral testimony focused on the same five recommendations that have been presented to - and approved by - the HOPPS Panel in previous years. Although supported by its expert panel, CMS has yet to adopt and implement them.

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In response to a Request for Information from Congress to collect stakeholder input, the Alliance provided a detailed collection of specific recommendations to strengthen the 21st Century Cures Act. With a unique wound care perspective, the Alliance letter focused on issues including: real world evidence, national and local coverage decision processes, local coding and billing article processes, the Coverage with Evidence Development paradigm, Contractor Advisory Committee engagement, the National Correct Coding Initiatives (NCCI), reconsideration request timelines, and more.

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The Alliance submitted comments to the medical directors of each Medicare Administrative Contractor (MAC) with specific recommendations to improve the local coverage determinations/local coverage articles on "Skin Substitute Grafts/ Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers." The Alliance provided detailed comments and substantive recommendations focused on the following key areas in need of resolution and clarity:

• Evidence, and the need for a consistent and equally applied methodology for the MACs assess and determine sufficient evidentiary support for coverage.
• Reconsideration processes, and the imperative for a predictable, consistent process under which manufacturers can submit new evidence for MACs review in a timely fashion so that there is a pathway to gain coverage as new evidence becomes available.
• Number of applications and treatment duration, with recommendations to more accurately reflect current peer-reviewed clinical evidence by increasing the number of applications allowed, and to recognize in the policy the needs of specific patient populations - like those with larger sized or deeper wounds - who will require more applications.
• Implementation timeline, with a request that MACs provide an extended implementation period to avoid interruptions to patient care.

See Alliance recommendations to the MACs to achieve better balanced, fair and clinically accurate policies, below.

• CTPs/(skin substitutes)
• LCDs
• Medicare Administrative Contractors (MACs)

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The Alliance provided oral testimony at the open public feedback sessions that each Medicare Administrative Contractor (MAC) held to collect stakeholder input on the proposed LCD "Skin Substitute Grafts/Cellular & Tissue-Based Products for the Treatment of DFU and VLU.”  The Alliance voiced support for the proposed LCD language permitting additional applications beyond the 4 application limit and the extension of the 12-week treatment period based on medical necessity with documentation provided in the patients’ medical record. The Alliance also requested more transparency and consistency regarding the evidentiary bar being applied to determine if coverage will be provided - noting that there are a number published, peer-reviewed studies supporting a range of products that for unknown reasons were not included on the MACs’ list of evidence reviewed. Finally, the Allianced encouraged the MACs to ensure they provide enough time to implement the LCD, once finalized, so not to negatively impact patient care. The comments below were delivered to: CGS Administrators (5/16/2024); First Coast Service Options (5/23/2024); National Government Services (5/16/2024); Noridian Healthcare Solutions (J-E on 5/16/2024; J-F on 5/16/2024); Novitas Solutions (5/24/2024); Palmetto GBA (5/29/2024) and WPS Insurance Corporation (5/22/2024). More detailed written comments will be submitted by the June 8 submission deadline. 

• CTPs/(skin substitutes)
• Medicare Administrative Contractors (MACs)

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