Flag on HHS penalties

Jan 09, 2024

Presented by Novavax

With Robert King

Driving the Day

The seal for the U.S. Department of Health and Human Services is displayed.

A proposed HHS rule that would impose high penalties on health care providers that don't share patient data is getting slammed by hospitals, doctors groups and others in the health care sector. | Jacqueline Larma/AP

‘UNFAIR’ SANCTIONS? HHS wants to penalize providers that don’t share data with patients or other providers by yanking their incentive payments, and groups across the health care sector are hammering the proposed rule.

In October, HHS proposed that hospitals be hit with penalties that could reach seven figures and cost doctors groups more than $160,000. It projected that typical hospital fines would be $394,000 and $686 for individual clinicians.

HHS would impose penalties by stopping payments for adopting electronic health records systems, with the goal of bolstering patient access as part of broader regulations preventing stifling the flow of patient data.

Groups representing providers, including hospitals and doctors, laid into the proposal, and insurers and tech groups have also piled on in written comments, for which the deadline recently passed.

Many argued the penalties are too steep, the regulations would create a substantial burden and the process needs to be clearer. Several groups called for less punitive steps like corrective action plans before penalties are levied.

“The proposed penalties are excessive, potentially overlapping and unfair,” the American Hospital Association said in its comments. “It may threaten the financial viability of economically fragile hospitals.”

A spokesperson for the Office of the National Coordinator for Health IT said the agency is “look[ing] forward” to reviewing the comments and “working toward finalizing the rule later this year.”

Here’s a sampling of comments from various groups:

Hospitals: The Federation of American Hospitals called for “educational” disincentives, at least until agencies and providers have had more practical experience dealing with claims of information blocking.

“It takes time and experience to ensure that clinicians appropriately share sensitive data without running afoul of HIPAA,” FAH wrote.

Doctors: The American Medical Association said it was concerned that the resulting penalties wouldn’t be proportional to the underlying conduct and the proposal doesn’t have a sufficient appeals process. The physician group also said the rule would dissuade participation in Medicare value-based care and quality initiatives and exacerbate Medicare payment issues.

Mental health providers: The American Psychiatric Association said providers aren't “willfully or maliciously” blocking data, and many psychiatrists might not understand how to avoid information blocking without sufficient outreach.

Tech groups: The Healthcare Information and Management Systems Society, or HIMSS, said many of its members are concerned that the regulations could repel providers from incentive programs instead of promoting data-sharing. HIMSS called for more incentives to encourage clinicians to comply.

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In Congress

Dr. Anthony Fauci arrives on Capitol Hill

Dr. Anthony Fauci (center) arrives on Capitol Hill to testify in front of the House Select Subcommittee on the Coronavirus Pandemic on Monday. | Scott Applewhite/AP

GOP TEES UP FAUCI GRILLING — House Republicans are making the NIH’s research into new viruses a pillar of their grilling of former top infectious disease expert Dr. Anthony Fauci, Robert reports.

At issue: The House Select Subcommittee on the Coronavirus Pandemic on Monday held the first of two days of closed testimony featuring the former head of the NIH’s infectious disease center. A major topic during the hearing was Fauci’s definition of gain of function, which he says aims to make viruses more transmissible to better examine them, Robert reports.

“I don’t know that every scientist who deals with this type of viral research understands his definition of operational gain of function,” said subcommittee Chair Brad Wenstrup (R-Ohio). “People have other definitions.”

That’s something “we need to look into a little bit more,” Wenstrup said.

Republicans have frequently probed gain of function and the NIH’s role in funding such research in recent years. Wenstrup said he would like to get Fauci “on the record” discussing more about his take on gain-of-function research.

The hearing resumes on Tuesday.

GOP focus: Republicans have said that Covid-19 might have leaked from China’s Wuhan Institute of Virology, which previously received HHS funding but not for gain-of-function research into coronaviruses. However, the virus’ exact origins, including natural transmission, remain unclear.

Democrats on the panel said Fauci was referring to a 2017 regulatory definition created in a guidance document. That document seeks to balance the benefits of any research into enhanced pathogens “while minimizing potential biosafety and biosecurity risks,” it said.

The guidance defines such enhanced pathogens as highly transmissible and deadly spread among humans. It also lays out the requirements for funding research into dangerous pathogens and what risk-mitigation measures are needed.

Dem response: “Fauci was able to clarify today that the layman’s term gain of function is a lot different than [what] is in the guidance document,” said Rep. Kathy Castor (D-Fla.).

But Rep. Marjorie Taylor Greene (R-Ga.) told POLITICO that Fauci engaged in a more “evil version” of science in reference to gain of function and said he should be put in jail.

“It’s like a Dr. Frankenstein science that American taxpayers would never want their tax dollars used for,” she said.

ANOTHER DOC CHECKS OUT — Rep. Larry Bucshon (R-Ind.) won’t seek reelection — marking the latest departure from Congress and the GOP Doctors Caucus.

Bucshon, a cardiothoracic surgeon, has served in the House since 2011 and has been vice chair of the caucus.

“It became clear to me over the Christmas holiday with much discernment and prayer that the time has come to bring my season in public service to a conclusion,” Bucshon said in a statement Monday.

Bucshon is the latest House health policy leader to head for the exits, joining Reps. Anna Eshoo (D-Calif.), Michael Burgess (R-Texas) and Brad Wenstrup (R-Ohio), among others — a trend that’s raised concern in health policy circles. The departures of several doctors could impact Medicare payment reform efforts.

Bucshon’s impending departure narrows the field of potential Doctors Caucus chairs in the next Congress. Burgess and Wenstrup — who chair the caucus along with Rep. Greg Murphy (R-N.C.) — have pointed Pulse to Bucshon and Reps. John Joyce (R-Pa.) and Mariannette Miller-Meek s (R-Iowa) as potential replacements.

TRANSPARENCY LATEST — A deal on legislation to increase transparency requirements so far appears elusive.

The House passed sweeping legislation for pharmacy benefit managers, insurers and hospitals last month and hopes to reach an agreement with the Senate on such provisions and so-called site-neutral payments.

Senate HELP Chair Bernie Sanders (I-Vt.) told Pulse Monday that he hasn’t discussed a pact with House negotiators. Senate Finance Chair Ron Wyden (D-Ore.) told reporters that he’s spoken with the House “a number of times” and with Senate Majority Leader Chuck Schumer about it, but Wyden declined to get into details of the talks or whether there could be a deal by the Jan. 19 funding deadline.

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DIGITAL HEALTH

THE FUNDING LANDSCAPE — Investors expected 2023 to be a year for venture funding for digital health startups to return to earth after a pandemic surge and for some companies to make difficult decisions like closing their doors or selling.

But, according to investment firm Rock Health, there wasn’t a spike in those sorts of moves.

“Last year was defined by startups leveraging creative measures to avoid those difficult steps,” Rock Health wrote in a report Monday.

Overall, funding dipped close to $5 billion from 2022 to 2023, but 2023’s funding total was still $2.6 billion higher than in 2019. Still, the final quarter of 2023 was the slowest quarter for funding since the third quarter of 2019.

Investments in digital health have fallen since 2021

What’s next: The pullback on investments could impact innovators.

“2024 will require some startups to face the music (raise at a reduced valuation, seek an acquisition or exit, or shut down),” Rock Health researchers Madelyn Knowles and Mihir Somaiya wrote.

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HOME HEALTH

NEW HOSPITAL-AT-HOME DATA — Programs allowing acute hospital care at home under pandemic waivers have gained steam, though data on outcomes and effectiveness has so far been limited.

A research letter published in the Annals of Internal Medicine on Monday offered new evidence.

The researchers from Brigham and Women’s Hospital, Harvard Medical School and Johns Hopkins University Medical School, among others, examined data from more than 5,100 hospital-care-at-home patients between July 2022 and June 2023. They found “low rates” of mortality — 0.5 percent during home care and 3.2 percent after 30 days — though there wasn’t a control group.

Congress has extended the Medicare waivers through the end of 2024 and is weighing their future.

Tune in on Wednesday, Jan. 10, as POLITICO explores Taiwan's upcoming presidential election. Hear from our panel on the potential outcomes to the race and the profound implications for U.S.-China relations depending on who wins. REGISTER HERE.

WHAT WE'RE READING

Healthcare Dive reports on Elevance's lawsuit against HHS about Medicare Advantage ratings.

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Novavax is a global leader in vaccine development and research. The company is working to make safe and effective vaccines available to help protect those who need them around the world. This includes an authorized vaccine for COVID-19 that’s currently available at major retail pharmacies across the U.S. Heading into the New Year, it is a critical time to learn about your vaccine options to safeguard your health against pressing diseases. You can help protect yourself, loved ones and colleagues by getting your COVID-19 vaccine. Because protecting one of us can help protect all of us. Learn more.