Get Up to Speed With Recent Wound Care Policy Updates

The Fall is a busy time in the policy world, as government agencies such as the Centers for Medicare and Medicaid Services (CMS) finalize policies for the fiscal year ahead such as the CY 2022 Physician Fee Schedule and more. Get up to speed on the latest payment and coverage policies that can impact wound care with this update from the Alliance of Wound Care Stakeholders.

Real world evidence: The Food and Drug Administration (FDA) is opening up the door to more real-world evidence (RWE) in 2022 and beyond with two new draft guidance documents issued: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (September) and Data Standards for Drug and Biological Product Submissions Containing Real-World Data (October). The acceptability of RWE has huge implications for wound care product development and payer coverage. Real-world evidence will be a focus at the Alliance’s upcoming Wound Care Evidence Summit, May 19–20, 2022. Mark your calendars. Registration opens on Dec. 1.

The 2022 Physician Fee Schedule: In November, CMS issued its 2022 updates and policy changes for Medicare payments under the Physician Fee Schedule (PFS). This 2,000+ page annually issued policy includes clinical staff labor rates, telehealth, evaluation and management (E/M) visits and more. Specific to wound care are updates—and some cuts—impacting payment for skin substitutes (also known as cellular- and tissue-based products for wounds, or CTPs) and synthetic skin substitutes, compression application, disposable negative pressure wound therapy (dNPWT) and more. See CMS’ fact sheet and the Alliance’s comments to the Agency.

2022 Hospital Outpatient Payments: In November CMS also issued its final CY 2022 Hospital Outpatient Prospective Payment System that guides Medicare payment rates for hospital outpatient and Ambulatory Surgical Center (ASC) services. Amid the policy’s provisions addressing areas spanning payment rates and prior authorizations are specific provisions addressing coding and payment CTPs (skin substitutes). See CMS’ fact sheet on updates for 2022 and the Alliance’s comments to the Agency.

Pneumatic Compression Coverage: Medicare Administrative Contractors Noridian and CGS issued in September a proposed local coverage determination (LCD) on Pneumatic Compression Devices (DL33829) stating that the use of pneumatic compression devices for the treatment of critical limb ischemia (CLI) is not “reasonable and necessary” for purposes of Medicare reimbursement. The Alliance has submitted written comments to strongly disagree with this conclusion.

Wound and Ulcer Care Coverage: Noridian also issued this fall a final LCD on Wound and Ulcer Care (L38904) as well as a final policy article on Billing and Coding for Wound and Ulcer Care (A58567).

Medicare Coverage of Innovative Technology: CMS repealed in November the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (originally published in January 2021), citing concerns that the regulation was not in the best interests of Medicare beneficiaries and needed additional consideration. The repeal notice included a public comment period to collect feedback on future rulemaking to explore an expedited coverage pathway for innovative technologies and a regulatory definition of the “Reasonable and Necessary” standard for Medicare coverage. See CMS’s fact sheet and the Alliance feedback to the Agency.

Marcia Nusgart, RPh, is the executive director of the Alliance of Wound Care Stakeholders—an association of medical specialty societies, clinical and patient associations whose mission is to promote quality care and access to products and services for people with wounds. Through advocacy and educational outreach in the regulatory, legislative, and public arenas, the Alliance unites leading wound care organizations and experts to advocate on public policy issues that may create barriers to patient access to treatments or care.

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