Policy Updates on Surgical Dressings, Wound Dressing Classifications, and More

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The Alliance of Wound Care Stakeholders has been busy the last few months with advocating for better policy on a range of issues affecting the wound clinic. Here is a roundup on what we’ve been doing and what results we’ve gotten.
 
Achieved updates in surgical dressing policy after educating durable medical equipment Medicare Administrative Contractors (DMEMACs) about issues. Following submission of a letter to the Centers for Medicare and Medicaid Services (CMS) contractors flagging concerns, the Alliance met with CMS DMEMAC medical directors in January to elevate the ongoing surgical dressings claims processing issues and inconsistent denials that have created a lack of access to alginate and other fiber gelling dressings. The Alliance also addressed issues regarding surgical dressing modifier quantity limitations and a lack of alignment in the claims processing system with the HCPCS and modifiers when a category of dressing is used for multiple wounds. We shared recommendations for process improvements and, at the DMEMAC medical directors’ request, submitted proposed policy revision language for consideration to address issues.
 
As a result of this advocacy: the DMEMACs published a February update to their joint surgical dressing policy article with the policy revisions recommended by the Alliance.
 
Led advocacy effort to seek withdrawal of Food and Drug Administration (FDA) proposed rule on classification of wound dressings with antimicrobials. The Alliance submitted comprehensive comments to the FDA's proposed rule and companion amendments on classification of wound dressings and washes that contain antimicrobials (eg, silver, polyhexamethylene biguanide, hypochlorous acid, and iodine) and other chemicals (eg, honey, petrolatum). Following release of the policy, the Alliance quickly formed a member workgroup of regulatory experts to assess impacts and develop recommendations, met with FDA staff to voice concerns, educated members, and mobilized stakeholders to submit aligned comments requesting withdrawal of the policy for further vetting given its many ambiguities and gaps.
 
The proposed rule would create "much greater confusion about requirements for wound dressings and result in the unnecessary removal of many important products from the market," the Alliance wrote in comments emphasizing that this could result in clinicians using more antibiotic products and exacerbating the very resistance problems that FDA is trying to address.
 
Pursued update to Medicare Part B HCPCS reimbursement of blood-derived products. In letters to MAC medical directors, the Alliance worked with law firm Epstein Becker Green to request an update to the Medicare Part B HCPCS reimbursement of blood-derived products. The letter emphasized that current policies do not reflect the work and costs associated with the preparation and administration of these products and flagged the MACs’ frequent denial of these claims despite the National Coverage Determination (NCD) for platelet-rich plasma and blood-derived products. The Alliance also sent a similar letter to CMS, then met with senior staff of the Agency's Hospital Ambulatory and Policy Group in February. A meeting with MAC medical directors has also been requested.
 
Flagged concerns with Acumen episode-based cost measure for non-pressure ulcers. CMS contracted with Acumen last year to develop an episode-based cost measure that is focused on any type of chronic ulcer that is not a pressure ulcer (ie, diabetic foot ulcers, venous leg ulcers, arterial ulcers, etc.). This is an important initiative to wound care clinicians as this measure will be considered for potential use in the Merit-based Incentive Payment System (MIPS). There could be significant negative consequences for wound care providers if the measure is not based on fair, meaningful and correct criteria.
 
Thus, after participating on several calls and reviewing field testing results, the Alliance informed Acumen in a March letter that we cannot support the measure as currently written. We flagged concern such as: costs 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, and tests being performed outside of a clinician TIN yet which are being attributed to them. We inquired why Acumen did not reflect the input of its clinical expert workgroup and requested an opportunity to discuss concerns.
 
Urged CMS to modify payment policy for measurement and fitting for lymphedema compression garments. In a letter co-signed with the American Physical Therapy Association, American Occupational Therapy Association, and Lymphedema Advocacy Group, the Alliance again 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 DME supplier, the letter advocated, noting the current policy doesn’t assure payment to the therapists who render these services.
 
Encouraged FDA/CMS dialogue on real-world evidence. 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. We reminded FDA that CMS and private payers currently do not accept RWE for coverage purposes. As such, even if the FDA permits RWE/RWD for regulatory decision making, unless CMS and commercial payers also accept it, manufacturers will need to provide one type of evidence to the FDA and another to payers for coverage and payment purposes. We encouraged FDA to dialogue with CMS and offered to serve as a resource and convener.

Requested revisions to Aetna policies, peripheral vascular intervention guidelines. The Alliance co-signed a letter with vascular and cardiology groups (including Alliance member the American Venous Forum) 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 for select interventions be removed.
 
Keep up with our 2024 advocacy work and ongoing activities here.  

Marcia Nusgart, RPh, is founder and CEO of the Alliance of Wound Care Stakeholders, the leading voice of wound care advocacy for the past 21 years. The Alliance unites leading wound care clinical organizations and experts through advocacy and educational outreach in the regulatory, legislative and public arenas to advocate on public policy issues that may create barriers to patient access to treatments or care. With a key focus on coding, coverage and reimbursement, quality measures and wound care research, the Alliance elevates the visibility and united voice of wound care providers to regulators and policymakers. Learn more here.