The U.S. FDA’s regulation of commercial speech under the First Amendment has been controversial and has handed the agency several losses in court, but Arun Rao of the U.S. Department of Justice let it be known that DOJ is still keen on commercial speech enforcement. Rao said the case of Gonzalez v. Google, which will be heard by the Supreme Court, is an example of potentially precedent-setting litigation, and that manufacturers of drugs and devices may experience an uptick in enforcement depending on where the Supreme Court lands in Gonzalez.

The Verifying Accurate Leading-edge IVCT Development (VALID) Act has been floating around Capitol Hill for the past four years, but was once again left by the wayside when Congress passed the latest round of U.S. FDA user fee legislation. Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said in a press briefing that the prospects for the legislation dim considerably if Congress does not pass the VALID Act by the end of the calendar year, raising the prospect that the FDA will act unilaterally to engage in rulemaking to deal with regulation of lab-developed tests.

The question of Medicare coverage for breakthrough devices is still in play at CMS, but managers there penned an Oct. 12 editorial that suggests that existing coverage mechanisms may have to suffice. CMS’s Lee Fleisher and Jonathan Blum said in the JAMA Internal Medicine (JAMA: IM) editorial that the agency might respond to the breakthrough device coverage question by applying the coverage with evidence development (CED) mechanism for breakthrough devices, suggesting that the policy might ultimately resemble the coverage mechanisms already available to industry.

The U.S. FDA’s agreement with industry for the fifth device user fee agreement (MDUFA V) included a pilot for the total product life cycle advisory program, or TAP, which is designed to ensure that potential device problems are addressed before production of the finished device design. However, the agency acknowledged that the TAP program will require significant numbers of new hires, which promises to be a significant hurdle given that the agency struggled to meet its hiring goals under the previous device user fee agreement.

The draft rule for the Medicare physician fee schedule (MPFS) for calendar year 2022 included a revised definition of the term “physician-owned distributorship,” or PODs, but the associated data collection requirements do not go into effect until January 2023. However, Amanda Johnston, managing attorney at Gardner Law of Stillwater, Minn., said recently that there is the possibility that this new definition could become a subject for enforcement action under the Anti-Kickback Statute (AKS), thus elevating the legal risks for device manufacturers who have not updated their compliance practices.

The Medicare coverage with evidence development (CED) program has served a vital function for coverage of medical technology for a number of years, but staff at CMS apparently see room for improvement. 

A number of devices, imaging systems and in vitro diagnostics have become available for colorectal cancer (CRC) screening over the years, several of which are of very recent origin, a marker of sustained interest and investment in these products. The problem for industry is that a new randomized trial conducted in Europe suggests that the impact of CRC screening on all-cause mortality is zero compared to no screening, a finding that could prompt policymakers to revisit their stances on screening to the detriment of sales of these devices and diagnostics.