NIH nominee walks the line

By Ben Leonard and Chelsea Cirruzzo

With Erin Schumaker 

Dr. Monica Bertagnolli testifies during her confirmation hearing to be the next NIH director. | Kevin Dietsch/Getty Images

IN BROAD STROKES — Dr. Monica Bertagnolli, President Joe Biden's nominee for director of the National Institutes of Health, didn’t bend to pressure from the Senate HELP Committee to state a position on prescription drug pricing during her confirmation hearing Wednesday, Erin reports.

“If you are confirmed to be the next NIH director, will you commit to reinstating and expanding the reasonable pricing clause in NIH contracts?" Chair Bernie Sanders (I-Vt.) asked.

Taxpayers deserve a fair return on their investment, Bertagnolli responded. She agreed to broadly ensure that the benefits of NIH research are affordable and available but stopped short of making the commitment Sanders asked of her.

“I cannot give further specifics at this time about the execution of that plan,” she told him.

The exchange comes after Sanders held up the National Cancer Institute director's nomination for months, vowing to oppose the administration’s health nominees until it took more actions on reducing drug costs. In September, after a deal between the federal government and the biotech company Regeneron that included a reasonable pricing clause, Sanders agreed to schedule Bertagnolli’s hearing.

Ranking member Bill Cassidy (R-La.) didn’t fare any better when he rephrased the drug-cost question, asking Bertagnolli whether she’d refrain from using the reasonable pricing clause.

Bertagnolli told him that she couldn’t commit to any particular policy.

But Bertagnolli was willing to take a stance on improving clinical trials.

“One of the other commitments I want to make is for clinical trials — since it’s been one of my core expertise — that are faster, more inclusive, more responsive to the needs of people,” she told the committee. “It’s one of the major initiatives that I’d like to see happen at NIH.”

What’s next? The committee plans to vote on Bertagnolli’s nomination Wednesday. If she’s approved, the full Senate would vote on confirmation when Majority Leader Chuck Schumer brings it to the floor.

Sanders hasn’t indicated how he’ll vote. Sen. John Barrasso (R-Wyo.), who chairs the Senate Republican Conference, said Wednesday he supported Bertagnolli’s nomination.

WELCOME TO THURSDAY PULSE. Close to 170 organizations convened by the Alliance for Connected Care, including Amazon, the ERISA Industry Committee and Walmart, are pushing Senate leadership to take up a bill that would expand access to telehealth for people on high-deductible health plans.

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TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with POLITICO health care reporter Robert King, who explains why CMS is cracking down on Medicare Advantage TV ads for what it calls misleading information and unsubstantiated claims and what the impact of the ad policing could have during Medicare’s annual open-enrollment period.

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. Cathy McMorris Rodgers says AI can help improve diagnoses but Congress needs to enact a national privacy standard to ensure the AI is trustworthy. | Francis Chung/POLITICO

HEALTH AI CONSIDERATIONS — Top lawmakers on the House Energy and Commerce Innovation, Data and Commerce Subcommittee on both sides of the aisle made it clear Wednesday: A national privacy framework is needed to ensure trustworthy artificial intelligence.

The full committee led such efforts last Congress, passing the American Data Privacy and Protection Act out of committee nearly unanimously, but it died amid opposition around preempting state laws. Lawmakers touted AI’s potential to spur innovation in several sectors, including health care, but also warned of risks.

Committee Chair Cathy McMorris Rodgers (R-Wash.) said in the first of a set of AI hearings Wednesday that the technology could help improve diagnoses in health care and help law enforcement fight the fentanyl crisis.

“Trustworthy algorithms are essential,” Rodgers said. “Failing to enact a national data privacy standard or allowing China to lead the way heightens the risk.”

Ranking member Frank Pallone (D-N.J.) expressed concern about AI-powered chatbots leaking medical information, and subcommittee ranking member Jan Schakowsky (D-Ill.) warned about AI fueling discrimination in health care.

Looking forward: It’s less clear how potential national privacy protections for data might intersect with the health care data covered under HIPAA — information from doctors, insurers and other providers. And the path forward for a national privacy framework remains unclear.

Pallone expressed concern that the House’s recent turmoil — especially ahead of a looming government shutdown deadline — could impact how much could be done on the issue.

Schumer said Wednesday that the chamber will hold its second AI forum next week, focusing on innovation — including “unlock[ing] new cures.” Sen. Mike Rounds (R-S.D.) and an artificial intelligence working group will also host a panel discussion today on AI in health care alongside Schumer and Sens. Martin Heinrich (D-N.M.) and Todd Young (R-Ind.)

SENATE EYES HEALTH COSTS — The Senate Budget Committee examined ways to help rein in health care spending on Wednesday.

Chair Sheldon Whitehouse (D-R.I.) raised concerns that the U.S. spends more on health care than many peer countries but has a lower life expectancy than them. He floated tackling the “dizzying web of administrative tasks” facing providers that add to costs, boosting transparency, addressing consolidation and moving toward value-based care.

Ranking member Chuck Grassley (R-Iowa) pointed to fighting fraud, reducing red tape and administrative burdens and boosting price transparency and competition as key starting points. He supports a shift to value-based care but added that lawmakers need to “accurately account for what’s working and what’s not working,” citing a recent Congressional Budget Office estimate that the Center for Medicare and Medicaid Innovation is on pace to increase spending by more than $1 billion through 2030.

The committee didn’t tackle specific legislation, but the discussion reflects lawmakers’ deliberations as both chambers look to reduce health care spending.

GO INSIDE THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO is proud to partner with the Milken Institute to feature a special edition of our Future Pulse newsletter at the 2023 Milken Institute Future of Health Summit from November 6-8. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators solving the biggest public health issues to ensure a healthier, more resilient future for all. SUBSCRIBE TODAY TO RECEIVE EXCLUSIVE COVERAGE.

PAXLOVID LIST PRICE — Pfizer will set its list price for Covid-19 antiviral Paxlovid at $1,390 per five-day treatment course, more than twice what the federal government had paid, a company spokesperson confirmed.

The new list price — which reflects costs before insurers, manufacturers and pharmacy benefit managers can lower prices — comes as the drug moves to the commercial market. The federal government had paid about $530 per course.

“Pricing for PAXLOVID is based on the value it provides to patients, providers, and health care systems due to its important role in helping reduce COVID-19-related hospitalizations and deaths,” the spokesperson said in a statement. “The list price does not necessarily reflect the price a patient will pay.”

The emergency use authorization-labeled treatment course will still be free for patients until the end of the year, and it will stay free for the uninsured and patients on Medicaid and Medicare through 2024. The Wall Street Journal first reported the news.

FLORIDA SYSTEM TO PAY UP — Miami-based Jackson Memorial Hospital is paying back $122 million to the state for getting too much money from a pool meant to reimburse hospitals for treating low-income residents, POLITICO’s Robert King and Arek Sarkissian report.

The settlement agreement, obtained by POLITICO, was reached on Sept. 28 between the hospital system and state and federal governments. It aims to resolve a series of billing errors dating back to 2010.

The errors were discovered by Jackson Memorial Hospital during a Justice Department audit. Most of Florida’s Medicaid program is regulated by the state Agency for Health Care Administration, and agency spokesperson Bailey Smith said that Jackson, the state’s second-largest hospital system, self-reported the error.

Jackson incorrectly billed the state’s Low Income Pool program, which is provided to people who are uninsured or underinsured.

A Jackson official said the error was an honest mistake. Over several years, the hospital system pursued reimbursement for medical services while trying to adhere to state regulatory guidelines that it believed was in accordance with federal requirements.

A message from PhRMA:

Kevin Ban is joining ixlayer’s clinical advisory board. He’s global chief medical officer at Walgreens Boots Alliance.

Meg Barron, previously of the AMA; David Silk, previously of TMRW Life Sciences; and Vanessa Juth, previously of Accenture, are joining the Peterson Health Technology Institute. 

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POLITICO's Janaki Chadha reports on New York City getting a new biomedical research hub.

STAT reports on the “Ozempic panic.”

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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