Pathways' Pick of the Week: New From CMS

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CMS proposes carotid stenting coverage expansion, and more Medicare news. Excerpted from Pathways' Picks July 12: Medicare Mélange and More from FDA, Europe, and China.

Carotid stent coverage expansion

A significantly larger population would be covered by Medicare to undergo carotid artery stenting outside of clinical trials under a July 11 proposal from CMS. The proposed National Coverage Determination would also remove current approval requirements for facilities that want to perform the procedure and it would institute a new “shared decision-making interaction” that would need to be documented between practitioner and patient. Currently, carotid stenting, which is an alternative to open surgery for preventing stroke, only receives Medicare coverage outside of a clinical trial in symptomatic patients at high risk for surgery with artery stenosis of 70% or higher. Under the proposal, stenting could be covered broadly in standard risk, symptomatic patients with 50% or higher stenosis and in asymptomatic patients with 70% or higher bcoverage of more tests, including Castle Bioscience DecisionDx-Melanoma and InterPace BiosciencesPancraGEN tests. The LCD had been scheduled to take effect July 17. The contractors say they plan to issue a new proposed LCD for comment soon. They didn’t state a reason for withdrawing the LCD, but some experts suggest it may have been because of the substantial differences between an original 19-page proposed LCD and the much longer final version. Home equipment updates. New payments and other reimbursement updates to durable medical equipment are being implemented by CMS in its recently published 2024 home health payment proposed rule. In particular, the agency is adding new documentation requirements for beneficiary refills of DME products. The agency is also codifying a congressional requirement that Medicare make a distinct payment for a disposable device use lockage. Regional Medicare administrative contractors (MACs) will have discretion to cover additional patients. Comments on the proposal are due August 10.

Home equipment updates

New payments and other reimbursement updates to durable medical equipment are being implemented by CMS in its recently published 2024 home health payment proposed rule. In particular, the agency is adding new documentation requirements for beneficiary refills of DME products. The agency is also codifying a congressional requirement that Medicare make a distinct payment for a disposable device used in negative pressure wound therapy (NPWT). Finally, it is implementing a new benefit category for compression items used to treat lymphedema.

Open payments posted

CMS updated its Open Payments database with 2022 disclosures. The database records financial relationships between drug and device manufacturers and healthcare providers, relying on mandatory annual disclosure reports from the companies. Drug and device firms spent a total of $12.59 billion on payments or other “transfers of value” (training, meals, etc.) to providers last year, according to CMS.   

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