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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDSCO eyes recognition of ASTM standards; Device makers, docs blast radiation oncology payment model.
Several telehealth bills are in circulation on Capitol Hill, but U.S. federal government agencies have expressed concerns about the potential for fraud and abuse, and the impact on Medicare spending. Despite those concerns, two key members of the House Energy and Commerce (E&C) Committee, Reps. Frank Pallone (D-N.J.) and Anna Eshoo (D-Calif.), said during a March 2 hearing that they have misgivings about those cautionary views of telehealth, suggesting that any related legislation will aggressively expand Medicare coverage of telehealth.
The separate “pass-through” payment Medicare provides for new, high-cost Part B drugs that are part of certain hospital procedures in the U.S. may be an incentive for hospitals to use those drugs rather than less expensive alternatives, according to a new Government Accountability Office (GAO) report.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Noridian overpaid for facet-joint injections; Hill-Rom patient lift recalled; New legislation directed to heart valve disease.
The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being.
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.
Stryker Corp. reported Jan. 27 that per-share earnings for the fourth quarter of 2020 reached $2.81, but organic sales fell roughly 1%, largely an artifact of the COVID-19 pandemic. The company’s acquisition of Wright Medical Group NV, of Amsterdam, is part of a source of optimism for the company, however, as is the fact that the company’s sales in emerging markets continue to buoy Stryker’s outlook for 2021.
COVID-19 undoubtedly will be the top U.S. health care priority for the 117th Congress and the incoming Biden administration, but that doesn’t mean prescription drug prices are no longer an issue. A raft of new-year price increases, many for already costly drugs, is ensuring drug pricing remains high on the congressional agenda.
As is the case with many national governments, the U.S. federal government does not routinely measure its activities in the calendar year, but we at BioWorld don’t share that outlook. CY 2020 was odd in more ways than one from a regulatory standpoint, and thus we offer our version of a regulatory top 10 for a year that might not look much better in the rear-view mirror than it has looked as a current event.
Telehealth has been topical in the U.S. for several years now, but the COVID-19 pandemic lent new urgency to the question of Medicare coverage. However, there are a number of related enforcement issues that could dampen adoption and increase the legal risk for both health care professionals and developers of telehealth-related products.
