Friday, February 9, 2024

Senate weighs AI health care regulations

Presented by the Coalition to Protect America's Health Care: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
Feb 09, 2024 View in browser
 
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By Chelsea Cirruzzo and Ben Leonard

Presented by

the Coalition to Protect America's Health Care

With David Lim 

Driving The Day

Senate Finance Committee Chair Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) preside over a hearing

Senate Finance Committee Chair Ron Wyden (left) and ranking member Mike Crapo held a hearing Thursday on regulating the use of AI in health care. | Francis Chung/POLITICO

HOW TO REGULATE AI? The Senate Finance Committee took its first crack Thursday at examining the regulation of artificial intelligence in health care, focusing on payment policies, responsible use and accountability.

“This committee has a responsibility to ensure there are guardrails in place to protect patients, particularly in Medicare and Medicaid, and I do not believe that current laws go far enough to achieve that goal,” Chair Ron Wyden (D-Ore.) said, touting his legislation that would mandate companies assess the impacts of automated decisionmaking and require reporting to the FTC.

Ranking member Mike Crapo (R-Idaho) struck a more cautious tone, saying Congress needs to learn more about the technology before legislating.

“One-size-fits-all, overly rigid, and unduly bureaucratic laws and regulations risk stifling life-saving advances and becoming outdated before they are even codified,” Crapo said.

Here are three of Ben’s takeaways from the hearing:

Who’s paying? Lawmakers and witnesses from tech groups and universities were interested in reimbursement for AI tools. Crapo said Medicare coverage needs to keep pace with AI to avoid “access gaps” widening. Sen. Bob Menendez (D-N.J.) probed witnesses about Medicare coverage gaps.

Peter Shen, head of digital and automation for North America at Siemens Healthineers, called for a “more predictable” reimbursement strategy from CMS. Mark Sendak of the Duke Institute for Health Innovation suggested there be incentive payments like Congress did with electronic health records in a 2009 law.

Advocacy group the AI Healthcare Coalition called for a permanent Medicare payment pathway for AI in a statement for the record.

Care denials in the crosshairs: Lawmakers on both sides of the aisle were wary of AI being used to deny care en masse.

Wyden suggested that HHS might have a future role in overseeing algorithms used in processes like prior authorization. Crapo said that improper denials or delays in care “warrant government scrutiny.”

A cost-saver? Both Democrats and Republicans were optimistic that AI could help reduce costs as Congress looks to rein in rising spending.

“Perhaps we’ll actually be able to bend the proverbial cost curve down in health care. We’ve tried seemingly everything else in Washington,” Sen. Todd Young (R-Ind.) said.

WELCOME TO FRIDAY PULSE. HHS Secretary Xavier Becerra said Thursday that he’s rooting for the San Francisco 49ers in the Super Bowl this weekend — and apologized to Kansas City Chiefs tight end Travis Kelce and his mega pop star girlfriend, Taylor Swift. Ben is also cheering for the 49ers, and I, Chelsea, am watching for Taylor Swift and Usher.

Send your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_.

 

A message from the Coalition to Protect America's Health Care:

Corporate Insurers Are Focused On Banking Record Profits At Patients’ Expense. https://protecthealthcare.org/latest/who-cares-for-you

 
In Congress

 Joaquin Duato, CEO of Johnson & Johnson; Robert Davis; CEO of Merck; and Chris Boerner, CEO of Bristol Myers Squibb testify before the Senate HELP Committee

Joaquin Duato (left), CEO of Johnson & Johnson; Robert Davis (center), CEO of Merck; and Chris Boerner, CEO of Bristol Myers Squibb testify before the Senate HELP Committee. | Kevin Dietsch/Getty Images

SANDERS VS. PHARMA CEOs — Sen. Bernie Sanders (I-Vt.) spent Thursday morning bemoaning the high cost of lifesaving drugs and excoriating drugmaker CEOs at a Senate HELP committee hearing. He pointed out that drugs in the U.S. cost significantly more than in other developed countries.

The leaders of Johnson & Johnson, Merck and Bristol Myers Squibb acknowledged the affordability challenges but would not agree to lower the prices. Instead, they asked that discounts won by the pharmacy benefit managers that negotiate prescription drug prices be passed on to patients and urged Congress to protect the U.S. biopharmaceutical industry from an economic environment that hinders the discovery of new medicines.

“There is a reason why the prices [in other countries] are different, and we need to be careful because we are also seeing in those markets that they are unwilling to support innovation,” Merck CEO Robert Davis said.

E&C CHAIR TO RETIRE The top Republican on the House Energy and Commerce Committee won’t seek reelection, the latest senior Republican on the committee to announce retirement, David reports.

Rep. Cathy McMorris Rodgers (R-Wash.) was instrumental in negotiating a five-year reauthorization of the FDA's user fee program and worked closely with ranking member Frank Pallone (D-N.J.) to co-author a major consumer privacy bill last Congress.

Rep. Brett Guthrie (R-Ky.), chair of the E&C Health Subcommittee, will run to replace her, his office confirmed.

Rep. Bob Latta of Ohio, who will be the most senior Republican on the E&C Committee next Congress, is running for the chair, per two people with knowledge of the matter.

Rep. Richard Hudson of North Carolina, chair of the National Republican Congressional Committee, is also being encouraged to run for the top committee role, according to two high-level Republicans familiar with the matter. If he ultimately launches a bid, that would mean Hudson would forgo seeking another term in leadership.

 

CONGRESS OVERDRIVE: Since day one, POLITICO has been laser-focused on Capitol Hill, serving up the juiciest Congress coverage. Now, we’re upping our game to ensure you’re up to speed and in the know on every tasty morsel and newsy nugget from inside the Capitol Dome, around the clock. Wake up, read Playbook AM, get up to speed at midday with our Playbook PM halftime report, and fuel your nightly conversations with Inside Congress in the evening. Plus, never miss a beat with buzzy, real-time updates throughout the day via our Inside Congress Live feature. Learn more and subscribe here.

 
 
At the Agencies

HHS Secretary Xavier Becerra speaks at the National Press Club.

HHS Secretary Xavier Becerra speaks at the National Press Club on Feb. 8, 2024. | Chelsea Cirruzzo/POLITICO

BECERRA TALKS PRIORITIES — HHS Secretary Xavier Becerra said Thursday that a global pandemic treaty would “likely” be wrapped up by May and warned that a Supreme Court ruling on the abortion drug mifepristone could have dire consequences for other drugs, Chelsea reports.

Speaking at a National Press Club event, Becerra stuck to known talking points, touting the Biden administration’s efforts on Medicare drug pricing, promising to enforce civil rights protections in health care and reiterating the administration’s support for access to reproductive health care.

Some highlights: 

On the mifepristone case before the Supreme Court: A Supreme Court ruling on the drug’s safety could have consequences for other drugs and medical devices, Becerra said, because it could undermine the FDA.

In December, the high court said it would hear the case brought by the conservative group Alliance for Hippocratic Medicine challenging policies expanding access to mifepristone. Those policies, issued in recent years by the FDA, have allowed the pills to be prescribed online, mailed to patients and dispensed at brick-and-mortar pharmacies.

Members of the Biden administration warned that a ruling against the FDA would invite ideological challenges to other medications, from contraception to Covid shots.

On a global pandemic treaty: Despite a lack of agreement among countries, Becerra was optimistic that a deal will likely be reached this spring. “I think we get a deal because it’s indispensable,” he said.

On Covid-19: Becerra, who met earlier this week with pharmacists to urge them to ensure people don’t pay huge amounts of money for Covid therapeutics, called the commercialization of vaccines and treatments a “brave new world.” He also said limited funding from Congress on HHS’ Project NextGen, aimed at developing new Covid therapies, means the agency must “limit the number of trials.”

On work from home: In response to a federal employee’s question about whether HHS would enforce a back-to-the-office policy, the secretary responded, “Of course.”

 

A message from the Coalition to Protect America's Health Care:

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Opioids

HIGHER NALOXONE DOSE CAUSES WITHDRAWAL — People who received a high dose of naloxone, an opioid-overdose reversing drug, were more than twice as likely to experience withdrawal symptoms than those who received half that dose, but there was no significant difference in survival, a CDC report out Thursday said.

Why it matters: The FDA approved an 8-milligram version of naloxone in 2021, but no study has been done on how it compares with the 4 mg product sold over the counter.

Between March 2022 and August 2023, the New York State Department of Health gave law enforcement 4 mg and 8 mg of naloxone nasal spray to treat overdoses. People who received the higher dose were more likely to experience opioid withdrawal symptoms, such as vomiting.

Lobby Watch

FIRST IN PULSE: PRICE TRANSPARENCY AT THE BIG GAME — Power to the Patients, a nonprofit co-founded by philanthropist Cynthia Fisher that’s pushing for more transparency around health care prices, has paid big money for a Super Bowl ad featuring musical artists Lainey Wilson, Jelly Roll and Valerie June.

Jelly Roll recently appeared on Capitol Hill to plead with Congress to take action on the fentanyl crisis.

Advertisements that air during the big game often run in the millions. Power to the Patients declined to share how much they paid for the ad but said it was part of a “multimillion-dollar” campaign.

 

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Names in the News

Dr. Sean Mooney is joining the NIH’s Center for Information Technology as its director next month. He is currently a professor of biomedical informatics and medical education at the University of Washington School of Medicine.

WHAT WE'RE READING

The Guardian reports on the high rates of Maui fire survivors facing depression and respiratory issues.

NBC News reports on a CDC study that found teens report using drugs, often alone, to ease anxiety.

 

A message from the Coalition to Protect America's Health Care:

Corporate insurers delay and deny patient care and burden hospitals, which are already operating on shaky financial footing. Read more about who prioritizes patients in this head-to-head comparison: https://protecthealthcare.org/latest/who-cares-for-you

 
 

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