Of all the things that irritate physicians about health insurance, prior authorization might be at the top of the list. That didn’t stop the U.S. Centers for Medicare & Medicaid Service (CMS) from imposing a prior authorization requirement for the implant of spinal stimulators and for cervical fusion with disc removal in the calendar year 2021 Medicare outpatient prospective payment system, however.

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 draft version of the U.S. Medicare national coverage analysis for blood-based biomarker tests for colorectal cancer (CRC) engendered a large body of support, but several stakeholders recommended that the Centers for Medicare & Medicaid Services (CMS) avoid prescriptiveness regarding the sensitivity and specificity for any tests that would be covered under the policy.

Two U.S. federal agencies at the Department of Health and Human Services (HHS) have finalized rules that affect how drug and device makers interact with the health care system, but under the Congressional Review Act, neither rule can go into effect until February 2021. This timeline comes up a couple of weeks after President-elect Joseph Biden is sworn in, thus raising the risk that the new administration at HHS will either modify or overturn these rules altogether.

Regulation of the digital health space is in some respects fundamentally different from traditional hardware medical devices, a fact that was highlighted during a Nov. 12 webinar hosted by the U.S. FDA. Nonetheless, several participants in the webinar made the point that the twin problems of coverage and reimbursement are critical issues for digital health as well, a problem that some see as requiring more collaboration between the FDA and the Centers for Medicare & Medicaid Services (CMS).

As might be expected, device makers have a lot of nice things to say about a recent proposal by the U.S. Centers for Medicare & Medicaid Services (CMS) to automatically cover technologies designated as breakthrough devices by the FDA. However, two trade associations and the Medicare Payment Advisory Commission (MedPAC) all expressed serious misgivings about a proposal to define the term “reasonable and necessary” as possibly contingent on private payer coverage.