In this week’s roundup: Looking out for the Medicare inpatient rule and new technology impacts in Next Picks, Europe progresses on controversial EU-wide health technology assessment proposal, China steps forward on reg reforms, Australia clinical guide, CPT codes, Biden’s budget, and dates to remember.
What we’re watching for:
Medicare inpatient rule. Eight devices are likely to be tapped for bonus payments and many more will be under consideration in the Medicare hospital inpatient prospective payment system (IPPS) proposed rule, expected out in April.
The New Technology Add-On Payment (NTAP) is a focal point in the IPPS for device companies, and, this year, CMS says there is record interest in the program, which awards up to an extra 65% of a technology’s cost above and beyond the standard inpatient DRG payment. The agency is considering 43 NTAP applications for FY 2022, a record number that is almost 60% more than last year. Of those, 24 are for medical devices, including 14 FDA-designated Breakthrough Devices. That designation is important because CMS opened up a streamlined NTAP pathway for Breakthrough Devices two years ago allowing such products to skip the most challenging, “substantial clinical improvement,” NTAP criterion. That means those devices will get the payment as long as FDA authorizes the device and it costs enough to warrant the payment.
Eight of the Breakthroughs are already approved or cleared by FDA and, thus, are likely to get a clear-cut thumbs up in the proposed rule. Those include two single-use duodenoscopes (Boston Scientific Corp.’s Exalt Model D and Ambu Inc.’s aScope Duodeno), an artificial intelligence-guided system for evaluating cardiac ultrasounds (Caption Health Inc.’s Caption Guidance), Medtronic plc’s Harmony transcatheter pulmonary valve system, which was approved last Friday, and several others. CMS, meanwhile, will provide detailed analysis, but no up-or-down decision, for the non-Breakthrough devices in the proposed rule. A final rule will be issued in late summer or early fall.