Questions about new health AI rules

From: POLITICO Pulse - Friday Dec 22,2023 03:21 pm

Dec 22, 2023

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By Chelsea Cirruzzo and Ben Leonard

Presented by

PROGRAMMING NOTE: We’ll be off next week for the holidays but back to our normal schedule on Tuesday, Jan. 2.

With Megan R. Wilson

Driving the Day

AI REG REACTION — HHS has new rules set to take effect in 2025 mandating artificial intelligence developers reveal more about how their algorithms work, Ben reports.

There’s support in the industry, but Pulse also heard skepticism about how effective the rules might be and questions about liability and scope.

The backstory: The Office of the National Coordinator for Health IT unveiled sweeping rules last week for AI used in most hospitals and doctor's offices. In short, the ONC regulations will require software developers to provide more data to customers to help providers determine whether AI products are “fair, appropriate, valid, effective and safe.”

The reaction: Major groups including the Coalition for Health AI — with members including Google, Microsoft and Duke Health — praised the rules.

“Putting some standards in place is really important,” Michael Pencina of Duke AI Health and the coalition’s co-founder told Pulse. “They found the right balance, for the most part, about putting things forward but not being overly prescriptive.”

Agency interaction: Still, there are questions about how ONC and the FDA, which also regulates AI-enabled medical devices, will work together. Cybil Roehrenbeck, executive director of the AI Healthcare Coalition, told Pulse that she wished ONC would treat products already regulated by the FDA differently.

The FDA’s scrutiny should count for something, Roehrenbeck said.

ONC said in its rule that it worked with the FDA to align regulations to reduce the compliance burden for AI developers covered by both agencies’ rules.

Liability: Roehrenbeck said that the ONC rules’ reliance on individual clinicians to make calls about AI’s trustworthiness also raises liability concerns. ONC said those are outside of the scope of its rule.

“If a medical device fails, we know how to move through that process,” Andrew Tomlinson, director of regulatory affairs at the American Health Information Management Association, told Pulse. “We need to have that same process for AI.”

And Roehrenbeck said she's gotten several questions about what algorithms the rules apply to, and that she's hopeful for more clarity.

The agency said the rule has a broad scope, covering models not directly involved in clinical decision-making that can affect care delivery, like those aiding supply chains.

An ONC spokesperson said the agency appreciates the “robust public feedback” and welcomes more of it.

WELCOME TO OUR LAST EDITION OF PULSE FOR 2023. Thanks for your readership, feedback, and tips all year! We’ll be back in 2024. Please keep sending your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard _.

TODAY ON OUR PULSE CHECK PODCAST, host Chelsea Cirruzzo talks with POLITICO health care reporter Daniel Payne about the ways artificial intelligence is already used across the medical landscape and how regulators are responding.

Listen to today’s Pulse Check podcast

A message from PhRMA:

PBMs decide if medicines get covered and what you pay, regardless of what your doctor prescribes. PBMs say they want patients to pay less, yet they often deny or limit coverage of lower-cost generics and biosimilars. Instead PBMs cover medicines with higher prices so they make more money. Learn more.

Lobby Watch

GRAIL LOBBIES UP — Cancer diagnostics company Grail added to its lobbying roster in Washington, hiring high-powered lobbying firms BGR Group and Williams and Jensen to work on issues including Medicare coverage for multi-cancer detection tests, Megan reports.

At BGR Group, Grail has former top health aide to ousted Speaker Kevin McCarthy (R-Calif.) Ryan Long in its corner. He is giving both "strategic counsel" to the company and advocating on issues related to oncology and multi-cancer diagnostics and screening, according to disclosures.

Long, who left Capitol Hill in October, has a one-year cooling off period during which he cannot lobby any members or staffers in leadership offices — but confirmed he is free to lobby the rest of the House and Senate, in addition to the Biden administration.

Alec Aramanda, who most recently served as the Medicare staffer for Republicans on the House Energy and Commerce Committee, is among the lobbyists on the Williams and Jensen contract. Disclosure forms say that the firm will work on a pair of bills that would allow Medicare to cover the tests Grail produces. Aramanda joined the firm last month. He did not respond to a request for comment.

Biotech giant Illumina, which purchased Grail in 2021, announced earlier this week it would be divesting from the company following years of fighting with antitrust regulators over the deal. According to the recently released lobbying disclosures, the two firms' work for Grail began on Dec. 1.

"As Congress prioritizes bipartisan legislation that helps ensure Medicare has the authority to cover multi-cancer early detection tests, Grail continues to educate on the science and engage on access barriers to cancer screening," a company spokesperson said in an email.

EYES ON THE PRIZE — Lobbyists for business and consumer groups are planning a slew of calls and meetings with lawmakers and staff in the first weeks of 2024 and considering ad buys — hoping to push stricter disclosure requirements on insurers, pharmacy benefit managers, hospitals and other health facilities over the finish line, Megan reports.

“We're going to take a break so members and staff can enjoy time with their families, but they'll start to hear from us again before they even get back to Washington,” said Adam Buckalew, a lobbyist representing Better Solutions for Healthcare, a coalition that includes AHIP and the American Benefits Council.

Earlier this month, the House passed a sweeping health package that would expand Trump-era regulations requiring hospitals and insurers to post their prices and negotiated rates for services — and the Senate has signaled an interest in moving the proposal. Lawmakers in both chambers have advanced measures that would force pharmacy benefit managers — the intermediaries between drugmakers and insurers — to be more transparent about their business operations.

The moves are part of a yearlong effort in Congress to address rising health care costs — an issue that could become particularly potent in the 2024 election year.

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At the Agencies

NALOXONE IN FEDERAL BUILDINGS — HHS and the General Services Administration, which oversees federal real estate, have updated nearly 15-year-old safety guidance to say that federal facilities should have naloxone, an opioid overdose-reversal drug, on site.

The updated guidance builds upon 2009 recommendations that agencies have automated external defibrillators to treat people having heart attacks. The new guidance recommends that AED stations be converted into “safety stations” that also have naloxone and items to stop hemorrhaging.

Public Health

HOLIDAY RESPIRATORY ILLNESS OUTLOOK — Nearly 172,500 people went to the emergency room last week for the flu, Covid-19 or respiratory syncytial virus, according to CDC data.

While the agency says numbers are lower than seen this same time last year, they also indicate that the respiratory illness season, which typically lasts through the winter months, has yet to peak.

According to CDC data, more than half of ER visits for the week ending Dec. 16 were for the flu and one-third were for Covid-19. RSV made up around 13 percent of visits. Most of the patients were children under 12 years old — whose visits have been increasing since October.

Yet, vaccination rates remain low with fewer than half the population receiving a flu shot and less than 10 percent taking the latest Covid shot.

Nursing home residents, a vulnerable population that the CDC has prioritized in its vaccination campaign, have a slightly higher rate: As of Dec. 10, 33 percent of nursing residents had received the latest Covid shot.

Meanwhile, 17 percent of adults 60 and older have gotten their RSV shot.

Names in the News

The Government Accountability Office announced five new Health Information Technology Advisory Committee members: Dr. Lee Fleisher of the University of Pennsylvania School of Medicine, Dr. Katrina Parrish of Humana, Dr. Randa Perkins of the H. Lee Moffitt Cancer Center, Rochelle Prosser of Orchid Healthcare Solutions and Dr. Mark Sendak of the Duke Institute for Health Innovation.

WHAT WE'RE READING

POLITICO’s Robert King reports on Congress’ decision to skip town without addressing a pending cut to doctor Medicare payments, which could cause new headaches for practices and patients, according to doctor groups who are seeking help from CMS.

The Washington Post reports on the baffling rise in colon cancer among young people.

Dr. Zeke Emanuel, senior fellow at the Center for American Progress, explains in STAT why health costs are the one exception to inflation.

A message from PhRMA: