The expansions of coverage of telehealth associated with the COVID-19 pandemic will persist after the pandemic is over, even if the post-pandemic utilization does not match the current rates and types of utilization. However, speakers on a recent webinar hosted by Moses & Singer LLP of New York said that state medical licensure practices after the pandemic could be a help or a hindrance to more widespread use of telehealth, an issue stakeholders will want to track as 2021 unwinds.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
The U.S. Centers for Medicare & Medicaid Services (CMS) has posted the Medicare physician fee schedule for calendar year 2021, a document that has drawn blistering reviews from a number of stakeholders. The criticisms generally revolve around the impact of higher rates for evaluation and management (E&M) services on other rates, but there is already legislation in play on Capitol Hill that would reverse the changes wrought by increases in rates for E&M services.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Medicare overpaid for facet-joint injections; FDA posts IIE policy for non-COVID tests.
Device makers have wondered in the past whether they like the idea of the Centers for Medicare & Medicaid Services (CMS) peering over the U.S. FDA’s shoulders in premarket applications, which might be a concern as well for the Medicare program for coverage of breakthrough devices. Tamara Syrek Jensen, director of the Coverage and Analysis Group at CMS, declined to say whether her office has any influence over what would be designated as a breakthrough device by FDA, stating little more than that “we will constantly be talking with the FDA” about breakthrough devices.
The annual publication of the draft Medicare physician fee schedule (MPFS) is an event, but this year’s draft has drawn substantial criticism from across the board, despite the promise of more coverage of telehealth. The Medical Imaging & Technology Association (MITA) and a coalition of surgeons have blasted the draft as a hazard to patient access to both evaluation and management (E/M) services and surgical procedures, both of which present substantial headwinds for the medical device industry.
The Trump administration has issued an executive order designed to improve access to telehealth for Medicare beneficiaries in rural America, making permanent numerous changes that had been temporarily added for the COVID-19 pandemic. The news arrives as the Centers for Medicare and Medicaid Services (CMS) posted the draft Medicare physician fee schedule (MPFS) complete with expanded use of telehealth for a number of services.
The draft Medicare physician fee schedule (MPFS) is always an event for makers of drugs and devices, and this year is no exception. This time, the draft proposes non-controversially to formalize the specialty practice of heart failure and transplant cardiology, a move that was anticipated. While telehealth would enjoy a renewal of momentum under the terms of the draft, novel oncology drugs would be reimbursed at the wholesale acquisition cost plus 1.35 percent, a considerable shave from the current standard of WAC+6.
