ARTICLE SUMMARY:
In this week’s roundup: A look ahead to the raft of 2022 Medicare payment rules that we expect out in the coming weeks; CDRH spotlights its guidance priorities, and more from FDA; EU notified body and legacy devices updates; China issues rules on manufacturer self-inspections that are now allowed; and updates on machine learning, MCIT politics, molecular test billing, and more.
Next Picks
What we’re watching for:
2022 pay rules. Activity is heating up toward finalizing 2022 Medicare payment policies. Both the Medical Device Manufacturers Association and AdvaMed are meeting with White House Office of Management and Budget and CMS officials this week to make a final pitch on some elements of the Physician Fee Schedule (PFS). Others are engaging policymakers on the pending hospital Outpatient Prospective Payment System/Ambulatory Surgical Center (OPPS/ASC) rule, as well as rules governing reimbursement for end-stage renal disease, home health, and one with key updates for durable medical equipment, prosthetics, and supplies (DMEPOS), all expected out in the coming weeks. All together, these rules will contain thousands and thousands of pages of policy developments with varying ranges of impact across the healthcare spectrum. Some key pending provisions include:
- POD points. Device firms are questioning a CMS PFS proposal to require so-called physician-owned distributorships (PODs) to identify themselves on the public Open Payments database. Original equipment manufacturers have complained about PODs and their subversion of device markets for years, and support more transparency for the operations. But industry trade groups say CMS’ proposed wording could end up adding to the market confusion if changes aren’t made.
