Developers of apps for digital health have struggled to obtain Medicare coverage in the U.S. for their products, an impasse that seems unlikely to resolve anytime soon. Jason Bennett of CMS said on a Feb. 9 webinar that while the durable medical equipment (DME) benefit category seems like a natural fit for digital health products, there are some statutory and definitional roadblocks, including that digital health products might not be durable enough to qualify.

The process of reauthorizing critical U.S. FDA user fee agreements (UFAs) for drugs, generics and biosimilars took its first step forward in Congress Feb. 3 as the House Energy & Commerce Subcommittee on Health dipped its feet into the new enhancements included in the agreements the FDA negotiated with stakeholders over the past two years.

The COVID-19 pandemic shone a bright light on the need for and utility of telehealth, which in turn prompted the U.S. Centers for Medicare & Medicaid Services (CMS) to temporarily expand telehealth coverage. Some of those coverage policies are set to expire when the public health emergency ends, and a group of stakeholders, including the American College of Cardiology, are urging Congress to pass legislation that would make some of these benefits permanent, a potential boon for many telehealth entities.

The COVID-19 pandemic has hit supplies and devices across a broad range of categories over the past two years, and the latest addition to the list is the blood collection tube. The FDA announced that this shortage affects all types of blood collection tubes, thus affecting tubes for all uses, not just those used for testing for the SARS-CoV-2 virus.

Genetic testing for health care purposes took a hit with the onset of the COVID-19 pandemic, but there are concerns about the volume of these tests in the four years before the onset of the pandemic. The U.S. Office of Inspector General (OIG) said recently that the data suggest possible fraud and abuse of the Medicare program, and that the picture suggests a need for a more concerted regulatory effort by the CMS.

The U.S. CMS has crafted a payment policy that covers both adjunctive and non-adjunctive continuous glucose monitors (CGMs) in the final rule for durable medical equipment (DME). Medtronic plc, of Dublin, heralded the move as “a very important benefit expansion” for the company’s customers, but the expanded coverage also pays for additional CGMs that work with Medtronic insulin pumps.

While the FDA’s reaction to the results of the Nov. 30 advisory hearing for the COVID-19 therapy molnupiravir is difficult to predict, demand for rapid antigen tests may jump considerably when this or any such product is approved. That increased demand could crunch supplies of these tests due to the convergence of any such approvals, the upcoming holiday season, and the 2021-22 flu season, a convergence that could hamper efforts to roll out these new therapies.

A number of members of the U.S. House of Representatives have penned a letter to the Centers for Medicare & Medicaid Services (CMS) in support of the Medicare Coverage of Innovative Technology (MCIT) rule, the second time in recent weeks the agency has heard from Congress. The net effect of these letters is to suggest that Cures 2.0, which would provide Medicare coverage of breakthrough devices, is not on solid footing, which if true would suggest that the Biden administration’s Advanced Research Projects Agency for Health (ARPA-H) is similarly endangered.