November 18, 2021
Maverick's Update
Only What Matters In Health Information Policy
The most important news of the past week is pretty obvious: Paul Rudd was named People Magazine’s 2021 Sexiest Man Alive. The weirdly-never-ages movie star celebrated with his Ant-Man cast. If you are embarrassed to say that you have never seen Ant-Man, the Marvel movie is about a thief-turned-superhero who wears an outfit (that totally doesn’t look like an Ironman suit) with subatomic particle technology that shrinks him to ant-like size. Paul Rudd’s character, Scott Lang, is as likeable as Paul Rudd himself, so when he goes “subatomic” and falls into the “quantum realm” for five long years (the quantum realm messes with time and space, apparently), everyone is so sad that they bring him back for the big Marvel movie finale: Avengers: Endgame. And that is where the FDA comes in. More in the One Thoughtful Paragraph below.
Other news from the quantum realm:
Consumer Data Privacy Oversight Begins. On November 17, 2021, the Senate Commerce Committee held a hearing to consider Georgetown Law Professor Alvaro Bedoya’s nomination to be an FTC Commissioner and it seems fairly safe to assume that he will be confirmed quickly. He is a well-respected privacy advocate who is expected to help execute the Biden Administration’s edict to prevent unfair data collection and protect consumer privacy.
The People Have Spoken on The Future of Interoperability. Steven Posnack, Deputy National Coordinator for Health IT, posted a blog post about what interoperability will look like in 2030 (a synthesis of comments received from the industry).
One More Rule, One Less Rule, One More Technology-Related Legislative Proposal.
HHS issued a new federal rule that will require health plans to report on prescription drug spending, including their most frequently used brand prescription drugs, the most costly drugs, and drug rebates, fees, and other PBM-related information. The new rule is part of the No Surprises Act and will be enforced starting in December 2022.
CMS rescinded a Trump-era rule that allowed Medicare coverage for “breakthrough devices” (MCIT rule), now leaving only “proven pathways” for new medical devices to seek eligibility for Medicare coverage. In a shocking development, the medtech industry is opposed to the rescission of the MCIT rule.
On November 16, U.S. House Reps. DeGette (D-CO) and Upton (R-MI) introduced the latest version of the 21st Century Cures 2.0 Act. The proposal would mandate that Medicare pay for breakthrough technologies (yes, like the rule that was just rescinded as noted above), make some pandemic flexibilities to virtual health services permanent, increase federal support of genetic and genomic testing for pediatric patients with rare diseases, and includes a national testing strategy for future pandemics.
One Thoughtful Paragraph
Paul Rudd’s character in Ant-Man is not the only guy who disappears for five years and then shows up again to save the day. Please welcome back the FDA Commissioner from five years ago: Dr. Robert Califf. Right now, he works at a big tech company (you may have heard of Alphabet -- which owns both Google Health and Verily Life Sciences, where Dr. Califf splits his time). To be clear, Dr. Califf is a nominee, with no known confirmation hearing date. But we figure he makes it through a confirmation process because he did before (in 2016) and who has time to find another willing soul? Mostly, we note that if confirmed, Califf is likely to press forward with FDA’s interest in “real-world data” (“RWD” is gathered from insurers' claims databases and provider's electronic medical records) to augment clinical trial data to get drugs and devices to market faster and see how they are doing after they get to market. Dr. Califf may want to review the latest from Brookings scholar Darrell M. West, who urges better regulatory oversight of healthcare AI applications, and Yale’s Joshua Wallach and his colleagues’ notes about the limitations of using RWD-based studies in lieu of post-approval clinical trials. Mostly, we are glad Dr. Califf is having his own movie sequel after such a long search for someone to lead the agency, but think People Magazine may stick with non-aging movie stars for their next Sexiest Man Alive. Just a guess.