ARTICLE SUMMARY:
In this week’s roundup: Anticipating an extension of Medicare’s hip and knee replacement bundled pay program, reforms to China’s device regulation, SUNSET delayed, MDUFA talks begin, and more updates from the EU, Switzerland, Brazil, Australia, and US FDA.
Looking ahead on the Medicare Comprehensive Care for Joint Replacement program, spotlighting China regulatory reforms, and more medtech policy from around the world.
Next Picks
What we are watching for next:
Bundled pay extension. Medicare’s bundled payment program for hip and knee replacements is set to expire after five years, but CMS is likely to extend the program in its current state for the short term and implement proposed reforms in the coming year.
The Medicare agency proposed a three-year extension to the Comprehensive Care for Joint Replacement (CJR) program in February 2020 that would be linked to reforms including a change to target price calculations and expanding the program to include outpatient joint replacement procedures. It also proposed restricting CJR to high-volume, non-rural hospitals in 34 designated regions that are required to participate and no longer allowing voluntary participation by other facilities. But CMS has yet to finalize the rule, so healthcare providers would have no time to implement the changes before the March 31 expiration. [CORRECTION: The CJR program was in fact extended by CMS in late 2020 until September 2021. CMS ultimately finalized the CJR three-year extension in on April 29, 2021.]
Market Pathways expects a final rule to be issued before March 31 that extends the program as it is currently designed—e.g., limited to inpatient procedures, allowing voluntary participation, and with current target price methods—and sets reforms in place to be implemented later this year or in early 2022. CJR features a single 90-day episode-of-care payment covering surgical and post-acute services. Device firms, which have increasingly reorganized relationships with customers and engaged in new risk-sharing care models, are championing the CJR approach, and pushed back on CMS’ proposal to restrict participation and to update its target price calculations. Meanwhile, hospitals and surgeons have grown wary of the mandatory nature of the program, arguing it restricts tailored approaches that may be more fruitful at specific facilities. (See “Medtech Backs Bundled Payments: Five Takeaways from Medicare Joint Replacement Plan Comments,” Market Pathways, July 22, 2020.)
