Submitted Comments

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)

Read More

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)

Read More

The Alliance submitted a letter informing Acumen that we cannot support the Non-Pressure Ulcers Episode-Based Cost Measure as currently written and articulating the many reasons the current version does not accurately capture the data necessary for a fair, reliable, accurate measure. The Alliance provided specific recommendations and refinements while emphasizing several key areas of concern, including:

• Costs being attributed to clinicians inappropriately: clinicians being held accountable for the work of other clinicians.
• Costs being attributed to a clinician for care provided in hospitals or facilities not associated with the clinician’s TIN.
• Tests being performed outside of a clinician TIN which they have no control over, yet which are being attributed to them.

As the measure will be considered for potential use in the cost performance category of the Merit-based Incentive Payment System (MIPS), it is important for it to be based on fair, meaningful and correct criteria. The Alliance offered to conduct an educational session on wound care to better inform Acumen’s work on the measure.

Read More

In a co-signed letter with the American Physical Therapy Association, American Occupational Therapy Association, and Lymphedema Advocacy Group, the Alliance urged CMS to modify its lymphedema compression garments payment structure to ensure that clinicians are compensated for the measuring, fitting, and training services they provide. This would ensure that beneficiaries have flexibility to receive these services from either their lymphedema therapist or their DME supplier, the letter advocated, noting that the current policy doesn’t assure payment to the therapists who render these services.

Read More

As CMS embarks on CY 2025 rulemaking, the Alliance submitted a letter urging the Agency to support patient access to CTPs (skin substitutes), level the playing field for manufacturers, and reduce Medicare Part B costs by adopting a universal average sales price (ASP) reimbursement methodology for all CTP products. The Alliance voiced concern, again, about  the Agency's past bundling proposals, which would be detrimental to patients—particularly among patients with large and/or more complex wounds. 

Read More

In comments submitted to the FDA's proposed rule on classification of certain wound dressings and companion amendments, the Alliance requested that the Agency withdraw the policy for further vetting. Alliance comments flagged the many "gaps and ambiguities" in the current policy, the reduced availability of wound dressing products that could result if the policy is implemented and the harm this could cause to patient care. "Though we agree with FDA that creating a classification regulation may provide added benefits regarding regulatory expectations, we believe the current proposal will create much greater confusion about requirements for wound dressings, and result in the unnecessary withdrawal of many important products from the market to the detriment of clinicians and their patients. These regulatory actions may result in clinicians using more antibiotic products, exacerbating the very resistance problems that FDA is trying to address through regulations on antiseptic-based wound dressings and washes. Therefore, the Alliance respectfully requests that FDA withdraw its current proposal, and if it desires to proceed, we ask that it publish a more detailed proposed rule, with companion guidance, addressing the points raised stakeholder comments," the Alliance wrote.

Read More

The Alliance submitted comments supporting the intentions of FDA's draft guidance Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices, which would make use of real-world data and RWE for clinical trials and in expanding indications for use on already approved or cleared devices. We reminded the FDA that CMS and private payers do not accept this type of data for most products - including medical devices - for coverage purposes. As such, even if the FDA adopts/permits real world data/evidence for regulatory decision making, unless CMS and commercial payers also accept real world data/evidence, manufacturers would need to provide one type of evidence for the FDA and another for payers for coverage and payment purposes. The Alliance encouraged the FDA to dialogue with CMS and offered to serve as a resource and convener so that dialogue focused on  realistic and workable solutions can move forward.

• FDA

Read More

The Alliance co-signed a letter with aligned vascular and cardiology groups (American Venous Forum, Outpatient Endovascular and Interventional Society & others) to address Aetna's medical policy revision to Policy 0382 Intravascular Ultrasound, Policy 0295 Peripheral Atherectomy and Thrombectomy Devices, and Peripheral Vascular Intervention Clinical Guidelines. The letter flagged inconsistencies with medical society guidelines and current evidence and requested that the "experimental" designation for Intravascular Ultrasound (IVUS) for select interventions be removed.

Read More

The Alliance submitted a letter to the Congressional Joint Committee on Public Health supporting “An Act Relative to the Definition of Podiatry” (H.R.2150/S.1453) – legislation that would modernize the podiatric scope of practice law in Massachusetts to allow podiatrists to treat the foot, ankle, and lower leg.

Read More

The Alliance submitted comments to the Partnership for Quality Measurement supporting expansion of the Global Malnutrition Composite Score in the Hospital Inpatient Quality Reporting (IQR) program from 65 years of age and older to 18 years of age and older. Inclusion of MUC2023-114 will ultimately improve patient care outcomes through standardized identification and treatment of malnutrition.

Read More