By Ben Leonard and Chelsea Cirruzzo

With help from Daniel Payne

Sen. Bill Cassidy has received comments he requested on his proposed changes to regulations for AI in health care. | Kevin Dietsch/Getty Images

INDUSTRY ASKS ON AI — Sen. Bill Cassidy (R-La.), ranking member of the HELP Committee, recently floated changes in artificial intelligence regulation in health care and sought feedback on the potential framework.

Pulse obtained a number of the responses from groups representing members across the sector, including hospitals, health IT leaders, health plans and more. Some responses called for lawmakers and regulators to avoid creating conflicting rules and overly broad approaches.

The American Hospital Association and CHIME, which represents health IT executives, agreed with Cassidy — who is also a physician — that regulation not focusing sufficiently on specific sectors like health care could impede innovation. AHA added that such an approach might be insufficient in addressing safety issues relevant to health care.

Some, including Rep. Greg Murphy (R-N.C.), a co-chair of the GOP Doctors Caucus, have called for AI to be regulated at the state level. The Confidentiality Coalition, which represents insurer groups like AHIP, pharmacy benefit manager groups like PCMA, tech companies like Amazon and pharmaceutical companies like Amgen, disagreed with that approach.

“A single national standard that preempts state laws in this area will avoid conflicting requirements and facilitate compliance without unduly restricting innovation,” the coalition wrote.

CHIME and the Confidentiality Coalition also warned against conflicting regulations at the federal level.

“Regulatory oversight is needed; however, it should not result in duplicative mandates or worsen administrative burdens on providers and clinicians,” CHIME wrote.

Ty Bofferding, a spokesperson for the ranking member, said that Cassidy was pleased by the “substantive feedback” he received and “evaluating potential policy options.”

Situational awareness: Congress is still wrapping its arms around how to regulate AI generally, as well as in health care. There’s plenty of optimism about the technology’s power to transform care but fear about potential consequences if it goes awry.

Cassidy said that rules should target specific sectors like health care, not broad “top-down” methods.

Senate Majority Leader Chuck Schumer held a forum last month on the potential regulation of AI and is eyeing a federal policy framework. Lawmakers have generally raised concerns about bias in health care AI, as well as privacy and transparency in how algorithms work.

So far, Congress hasn’t taken substantial action, but federal agencies like the FDA and the Office of the National Coordinator for Health IT have proposals on how to regulate the technology. Reps. Anna Eshoo (D-Calif.), ranking member of the Energy and Commerce Health Subcommittee, and Dan Crenshaw (R-Texas) have introduced legislation to examine how AI might threaten biosecurity.

WELCOME TO WEDNESDAY PULSE. Are you working on AI legislation? We want to hear from you. Reach us with tips, feedback and news at [email protected] or [email protected]. Follow along @_BenLeonard_ and @ChelseaCirruzzo.

TODAY ON OUR PULSE CHECK PODCAST, host Lauren Gardner talks with POLITICO reporter Robert King, who outlines Medicare's process for negotiating prices for the first 10 drugs selected, beginning with seeking input from patients.

A message from PhRMA:

PBMs are siphoning money away from you.  They decide what you pay and what medicines you can get. PBMs steer you toward pharmacies they own that make them more money.  And, they’re creating new fees that pad their profits, but don’t benefit patients. Learn more.

Rep. Kevin McCarthy's ouster from his House speaker role could lead to further delays in funding some health programs. | Francis Chung/POLITICO

MCCARTHY OUSTED — Democrats and a small group of Republicans voted to oust former House Speaker Kevin McCarthy from his post.

It is the first time it’s ever happened in Congress — and has sent the chamber into chaos. Rep. Patrick McHenry (R-N.C.) is now speaker pro tempore, giving him the full powers of speaker until a new one is chosen. McHenry is a close ally of McCarthy.

Until a full-time speaker is chosen, focus will likely be on who takes over next, which could impede efforts to fund the government and pass legislation.

Lawmakers have until Nov. 17 to reach a deal to fund the government. Congress also let a number of health programs expire, including the global HIV/AIDS program known as PEPFAR and the SUPPORT Act tackling the opioid epidemic, and is looking to address them.

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RISE IN MORTALITY AMONG WOMEN — The mortality rate among American women and children rose between 2020 and 2021, according to a new report by the United Health Foundation.

The report, which analyzed federal data, found a 16 percent increase in mortality among women of reproductive age from 2020 to 2021 and a 7 percent increase in mortality among children, though the infant mortality rate dropped 4 percent.

Why it matters: The report highlights ongoing health challenges for women, such as a 9 percent increase in the maternal morbidity rate and a 27 percent rise in drug overdose deaths, areas the White House and lawmakers have made a priority in addressing.

Other measures highlighted included:

— A 16 percent increase in reported mental distress

— A 10 percent decline in teen births

— A 15 percent decline in smoking among women of reproductive age

The report also ranks Minnesota as the healthiest state for women in children in 2021 — thanks to its low infant mortality rate and high secondary school completion — with Mississippi listed as the least healthy state, attributed to a high mortality rate among women and infants plus high rates of child poverty.

A message from PhRMA:

FDA CLEARS NOVAVAX JAB — The FDA granted emergency use authorization to Novavax’s updated Covid-19 vaccine for people 12 and older, making it the first non-mRNA option available ahead of the fall vaccination campaign, POLITICO’s Katherine Ellen Foley reports.

In September, the CDC recommended that everyone 6 months and older get a new Covid shot amid rising hospitalizations. The agency also recommended high-risk people get an additional updated shot. At that point, the FDA had cleared Pfizer-BioNTech and Moderna shots.

Now that Novavax’s shot has been FDA-authorized, it will also fall under the CDC’s recommendations.

Those who have received prior Covid vaccines should receive one dose of the Novavax shot at least two months after their most recent vaccination, and those who have never been vaccinated should receive two shots three weeks apart.

The CDC’s endorsement means the shot will be available at no cost through private insurance, Medicare and Medicaid, plus federal programs for individuals who lost their insurance when the public health emergency ended in May.

Novavax said it anticipates the shots will be available in pharmacies this week.

A NEW POLITICO PODCAST: POLITICO Tech is an authoritative insider briefing on the politics and policy of technology. From crypto and the metaverse to cybersecurity and AI, we explore the who, what and how of policy shaping future industries. We’re kicking off with a series exploring darknet marketplaces, the virtual platforms that enable actors from all corners of the online world to traffic illicit goods. As malware and cybercrime attacks become increasingly frequent, regulators and law enforcement agencies work different angles to shut these platforms down, but new, often more unassailable marketplaces pop up. SUBSCRIBE AND START LISTENING TODAY.

STRIKE ON — More than 75,000 Kaiser Permanente health workers across several states are set to walk off the job today in what could be the largest health care strike in U.S. history, Daniel reports.

The workers, many in California, argued the need for better working conditions, including resolving staff shortages. Union leaders said Kaiser wasn’t negotiating in good faith to invest in its workers and improve gaps in its workforce.

But Kaiser’s leaders argued the group leads the industry in compensation and has worked to overcome staff shortages that have affected the sector. The strike is expected to last three days. A Kaiser spokesperson said Tuesday night that the company is “optimistic” that an agreement could be reached before work stoppages.

With some of their frustration stemming from post-pandemic effects like workforce shortages, health workers have seen new leverage from a smaller supply of labor. Some systems offer tens of thousands of dollars in sign-on bonuses for health workers as Congress continues deliberating over policy solutions to fill the labor gaps.

Axel Bernabe, the former chief of staff for New York’s Office of Cannabis Management, is now a partner at Manatt. 

Razia Hashmi has been named vice president of clinical affairs at Blue Cross Blue Shield Association. She was previously at Elevance Health. 

The Washington Post reports on the factors driving life expectancy falling in the U.S.

Healthcare Dive reports on Molina not receiving an Indiana Medicaid contract it was expected to receive.

POLITICO's Robert King has an explainer on the next steps in Medicare drug price negotiations.

A message from PhRMA:

Health insurers and PBMs can refuse to share savings that should go to you. Now they’ve got another trick. A new report shows  PBMs found new ways to profit off your prescriptions. They’ve doubled the amount of fees they charge on medicines in the commercial market. They tie these fees to the price of medicines. And experts warn this can lead PBMs to cover medicines with higher prices instead of lower-cost options. 

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