| | | | |  | | By Daniel Payne, Erin Schumaker and Ruth Reader | | | | | 
Thune could lead the Senate GOP come November. | Francis Chung/POLITICO | The end of the current Congress could bring a spate of health care legislation later this year, Sen. John Thune (R-S.D.) told the American Hospital Association at the trade group’s annual meeting in Washington this week. Thune could have a big say in what gets done. He’s a contender to lead Senate Republicans during a lame-duck session because Minority Leader Mitch McConnell is stepping down after the November elections. Thune’s forecast: He wants to make permanent rules permitting eased access to telehealth for Medicare patients that Congress approved at the height of the pandemic. The Connect for Health Act, a bipartisan bill from Thune and his colleagues, would remove restrictions on telehealth use based on geography or the classification of providers. “I’m hopeful,” he said of passing the legislation. “We have to figure out how to pay for it, but I think we can do that in the context of a broader bill.” Budget scorekeepers expect eased telehealth rules would raise Medicare costs because the service is usually easy to use and might spur patients to call their doctors more often. What else? Reforms to the way pharmacy benefit managers, the middlemen between insurers and drugmakers, operate; changes to how Congress sets Medicare payment rates for doctors; and updates to a program that helps hospitals serving poor communities pay for medicines — could all move, Thune said. Though some of those policies could offer savings to pay for telehealth changes, some could bring competing costs. And as for AI? Thune urges lawmakers not to assert too much authority in the artificial intelligence landscape, encouraging an innovation-forward approach that puts more control in the hands of the health industry, “using a light touch rather than a heavy hand.” “We want to make sure that we are mitigating, if possible, some of the riskier applications,” he said. But “a lot of that’s just, again, basic transparency.” Last fall, Thune teamed with Sen. Amy Klobuchar (D-Minn.) on a bill that would subject some AI systems to Commerce Department oversight.
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Litchfield, Conn. | Shawn Zeller/POLITICO | This is where we explore the ideas and innovators shaping health care. Large-scale cancer vaccine trials should report results within the next couple years, according to Harvard Medical School Professor Catherine J. Wu, raising hope for patients. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Ruth Reader at rreader@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp.
| | |  Doudna sees uses big and small for the gene-editing technology she co-invented. | AP | Gene-editing technology could one day be used to treat a wide range of diseases, from cancer to mental illness. Nobel Prize-winning biochemist Jennifer Doudna told an audience at the National Institutes of Health this week that scientists are grappling with how to make CRISPR, the gene-editing technology she co-invented, more affordable and accessible. Why it matters: In December, the Food and Drug Administration approved two therapies to treat sickle cell disease, a painful inherited condition in which red blood cells don’t function properly. “What’s extraordinary about this type of therapy is that it’s ideally a one-and-done treatment that can correct a disease-causing mutation, or in the case of sickle cell disease, override the effect of a genetic mutation,” Doudna said. “We’re still, I think, at the very beginning of this field and what will be possible with CRISPR.” Even so: High cost and complicated delivery mechanisms are holding CRISPR back. The list price for the one-time sickle cell treatment exceeds $2 million. In addition, CRISPR involves invasively collecting patients’ cells and editing them in a laboratory. “We are very excited and imagine a day when that won’t be necessary, and it could be possible to deliver the CRISPR genome editors directly in the patients,” Doudna said. Doudna is working on a project with the Innovative Genomics Institute, the California research organization she founded, that involves making targeted changes to individual genes. On the lighter side: Doudna pointed to the CRISPR tomato that Japan approved. Doudna is growing her own purple CRISPR tomato in her garden, she said, adding, “It has a snapdragon gene in it, so it’s kind of fun.”
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Europe's trying to figure out how to regulate psychedelic medicines, just as the U.S. is. | Getty | How psychedelics might help people with intractable health conditions is a challenge regulators are grappling with on both sides of the Atlantic. The European Medicines Agency, the EU equivalent of the U.S. Food and Drug Administration, is wrapping up a workshop in Amsterdam on psychedelics today. A key issue under discussion: how to regulate psychedelic drugs used in conjunction with therapy. “This doesn’t fit the frames that we have: It’s either a pill or it’s psychotherapy,” Robert Schoevers, a psychiatrist from the University Medical Center Groningen, told our team in Europe. “There’s those who are leaning toward ‘this is a pill with support’ on one extreme, and the others that this can only be applied within a … more lasting psychotherapy frame,” he said. Schoevers is leading the first clinical trial fully funded by the EU to study the effects of psilocybin — aka magic mushrooms — on patients with chronic obstructive pulmonary disease, including emphysema and chronic bronchitis; multiple sclerosis; treatment-resistant Parkinson’s disease; and amyotrophic lateral sclerosis, or ALS. In America: The FDA is considering Lykos Therapeutics’ application for talk therapy combined with MDMA, also known as ecstasy, as a treatment for post-traumatic stress disorder. The FDA granted Lykos’ application priority review and set an Aug. 11 target date for deciding whether to approve it. The House Veterans' Affairs Health Subcommittee advanced a bill on Tuesday directing the VA secretary to produce a report for Congress within six months of the FDA approving a psychedelic drug. "These therapies have a huge potential to help us address the mental health and suicide crisis among our veterans," said Rep. Jack Bergman (R-Mich.), who co-sponsored the bill. Should the bill become law, the secretary must report on his decision of whether to include the newly approved or licensed psychedelic drug in the VA formulary — and his justification for that choice. Rep. Derrick Van Orden (R-Wis.), another bill sponsor, said the suicide crisis among veterans with PTSD is a driving force behind the legislation. "I am not fully sold on these psychedelic things," he said. "But I'm unwilling to go to another damn funeral because we didn't try everything we could." | | | | Follow us on Twitter | | | | Follow us | | | | |
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