Lab practices go under the microscope

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May 07, 2024 View in browser   By Ben Leonard and Chelsea Cirruzzo With Kelly Hooper Driving The Day Gain-of-function research is the focus of a new White House policy that imposes tighter oversight for high-risk studies. | Kena Betancur/Getty Images ‘GAIN-OF-FUNCTION’ CRACKDOWN — The Biden administration is tightening oversight of high-risk "gain-of-function" research after controversy over the origins of the Covid-19 pandemic heightened scrutiny of the practice, POLITICO’s Carmen Paun reports. The White House's Office of Science and Technology Policy issued a new policy beginning a year from now that applies to federal agencies funding research that could lead to disease outbreaks or other serious health threats. It also includes research that could threaten agriculture, animal health or national security. The details: Researchers who want to increase a pathogen's transmissibility or virulence or create a new toxin must submit a risk-mitigation plan to the agency funding the work. The agency will assess risks and benefits when deciding on funding. The policy will apply to researchers studying coronaviruses, including the one that caused the pandemic and the Ebola and mpox viruses. Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security and a former Biden administration official in charge of Covid testing, said the new protocols are common sense. “It seems like this is the kind of policy that a member of the public who is not studying these issues on a day-in, day-out basis, this is the kind of thing that they would assume was already in place,” he said. The bigger picture: U.S. agencies are split on Covid’s origins, which have been a point of contention. The National Intelligence Council favors a theory of natural origin, while the FBI and Department of Energy think it stemmed from a lab. Gain-of-function research has come under scrutiny, with theories centering around a lab in Wuhan, China, where the NIH funded coronavirus research. Many have called for stronger oversight over risky research. Lawmakers on both sides of the aisle have said China has blocked efforts to determine Covid’s origins. Rep. Brad Wenstrup (R-Ohio), chair of the House Select Subcommittee on the Coronavirus, which is looking into Covid’s origins, has said he’s leaning toward an accidental lab leak as the cause and hopes that artificial intelligence can replace gain-of-function research. WELCOME TO TUESDAY PULSE. We’re very happy to report that there are very cute ducklings at the Capitol Reflecting Pool. Reach us and send us your tips, news and scoops at bleonard@politico.com or ccirruzzo@politico.com. Follow along @_BenLeonard_ and @ChelseaCirruzzo.   THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists. Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.     In Congress Both chambers of Congress are set to take up several health policy hearings this week. | Francis Chung/POLITICO THE WEEK AHEAD — Congress is in session this week and has a plethora of hearings slated on health care. A House Ways and Means Committee markup of a two-year extension of eased Medicare telehealth rules will arguably be the most consequential: The pandemic-era rules making it easier for older Americans to use telehealth are set to expire at the end of the year, and it’s growing increasingly likely that Congress won’t yet make them permanent. The legislation being considered Wednesday would extend those rules through the end of 2026. It would also require a watchdog report analyzing fraudulent claims for laboratory tests. Lawmakers will also consider several other bills related to rural health care. We’re following a number of other hearings, including: — A House Appropriations subcommittee hearing today on the Drug Enforcement Administration’s budget request, with DEA Administrator Anne Milgram testifying — A House Small Business Committee hearing Wednesday examining how “regulatory burdens” impact small businesses in health care — A Senate Appropriations subcommittee hearing Wednesday on the FDA’s budget request for the agency, with Commissioner Robert Califf testifying — A Senate Budget Committee hearing Wednesday on “alleviating administrative burdens” in the sector, with a focus on minimizing paperwork and costs — A Senate Foreign Relations Committee hearing Thursday, where lawmakers will consider John Nkengasong’s nomination to be ambassador-at-large for global health security and diplomacy AROUND THE AGENCIES A BRIGHTER TRUST FUND PICTURE — Medicare and Social Security will be able to fully pay for benefits longer than previously thought amid stronger-than-expected economic growth, according to an annual trustees’ report released Monday, Kelly reports. Medicare’s hospital fund, which covers Medicare Part A, will be able to fully pay claims through 2036, five years longer than projected in last year’s report. Social Security’s combined trust funds are expected to be able to pay full benefits until 2035, one year later than projected last year, according to the trustees. Key context: The report comes two months after President Joe Biden’s budget proposed increasing the Medicare tax on incomes above $400,000 to help extend the solvency of the Hospital Insurance trust fund. That proposal is unlikely to advance in Congress. Trustees attributed the improved estimate for its hospital fund to several factors, including a policy change that corrected for the way medical education expenses are accounted for in Medicare Advantage rates starting in 2024, a stronger-than-expected economy that produced higher payroll tax revenue and lower-than-expected Medicare expenses in 2023. Even so: Medicare still faces long-term financial shortfalls that Congress would need to take action on to keep the program solvent. The funding would require raising the 2.9 percent payroll tax to 3.25 percent or cutting Medicare’s hospital expenditures by 8 percent, according to the trustees report. DIGITAL HEALTH TELEHEALTH STATE TRENDS — The pandemic significantly shook up states’ approach to telehealth, according to a new report from law firm Foley & Lardner's telemedicine and digital health team. Here are the firm's main takeaways:  — More than a third of states passed legislation permanently enshrining audio-only telemedicine coverage for health plans, but payment rates vary. — As of this year, 33 states have laws on telehealth payment parity or payment rates, up from 16 states five years ago. But the group said many of the laws aren’t “true payment parity” and some have parity for only virtual mental health care. — After the public health emergency ended, many states amended laws to bar health plans from requiring that in-network providers use specific virtual care software. — Fears of lower quality of care via telemedicine didn’t come to pass. “Waiving the telehealth laws during the PHE did not result in widespread quality of care failures nor increase fraud [and] abuse,” attorneys Nathaniel Lacktman, Jacqueline Acosta and Jessica Warwick wrote. CASH STARTS TO FLOW — Around 800,000 people will begin to get notices that they can receive refunds from a Federal Trade Commission settlement with virtual mental health firm BetterHelp over data misuse claims, the FTC said Monday. People who received services between August 2017 and December 2020 will be eligible. The $7.8 million agreement was tied to allegations that the company shared sensitive health data with third parties for advertising purposes despite saying it wouldn’t. The company agreed to change several business practices and was barred from sharing health data with Meta and others for advertising purposes. The settlement wasn’t an admission of wrongdoing, the company said, adding that its practices were “industry-standard.” The bigger picture: The development comes amid a broader crackdown by the FTC on sharing consumer health data. Last month, it updated a 2009 data breach rule to clarify that breaches include unauthorized data-sharing with third parties, including advertisers.   LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.     Names in the News Former Sen. Richard Burr (R-N.C.) will lead the U.S. Chamber of Commerce’s business coalition to fight back against the Biden administration’s proposal to exercise so-called march-in rights in an effort to lower drug prices. After he departed Congress last year, he joined DLA Piper to lead its health policy strategic consulting practice. Lindsey Bornstein has joined McDermott, Will & Emery as a PR manager. She was previously at Hogan Lovells. WHAT WE'RE READING STAT reports on NYU professors working with Juul executives without disclosing the relationships to Congress or academic journals. The Associated Press looks at a gene that could be responsible for some cases of Alzheimer’s disease. POLITICO’s Ruth Reader reports on retail giants struggling in health care.   Follow us on Twitter Dan Goldberg @dancgoldberg Chelsea Cirruzzo @chelseacirruzzo Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM Sophie Gardner @sophie_gardnerj Kelly Hooper @kelhoops Robert King @rking_19 Ben Leonard @_BenLeonard_ David Lim @davidalim Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker Megan R. Wilson @misswilson   Follow us

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