Policy Briefs: What's New From FDA And CMS
This article was originally published in The Gray Sheet
Updates include an FDA safety communication for the Lariat suture device addressing use for left atrial appendage closure, new FDA draft guidance documents, and CMS proposals to cut radiation therapy payments and launch new payment models for hip and knee replacements.
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US FDA has issued a final guidance document discussing appropriate labeling for products containing heparin. The new rules reflect recent revisions to US Pharmacopeia monographs on heparin solutions.
CMS gave hospitals and other providers more time to prepare for an expanding bundled payment program targeting hip and knee implant procedures, moving a proposed Jan. 1 start date to April.
Key device updates in CMS's latest payment rules include reforms to the hospital outpatient pass-through payment process for new technology, the agency's continued march forward on "comprehensive" outpatient procedure payments, scaled-back physician cuts for radiation oncology and reimbursement for transoral GERD procedures.