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.

The U.S. Centers for Medicare & Medicaid Services (CMS) had packaged a proposal to redefine the term “reasonable and necessary” along with the proposal to cover FDA-designated breakthrough devices, but ultimately punted on the definitional question until the end of this year. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that it may be just as well that the agency didn’t expeditiously push through the reasonable and necessary question because of the enormous complexity of the proposal.

The impetus to provide more Medicare coverage of telehealth may prove irresistible, but the Medicare Payment Advisory Commission (MedPAC) has some reservations, including that telehealth payment rates should not favor companies like Dallas-based Teladoc Health Inc. over bricks-and-mortar clinics. This and other considerations are driving the commission toward a recommendation that a two-year telehealth pilot program would be more appropriate than simply jumping into a quickly broadened world of Medicare telehealth coverage.