CMS sends first price offers to drugmakers

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Feb 01, 2024 View in browser   By Chelsea Cirruzzo and Ben Leonard With David Lim and Robert King Driving the Day Drugmakers find out today the CMS prices for the drugs subject to Medicare negotiations. | Scott Olson/Getty Images FIRST MEDICARE DRUG PRICES GO OUT — Today, CMS is sending to drugmakers the initial prices for the 10 products selected for the first Medicare negotiations, Robert and David report. The agency didn’t divulge the exact prices it would give to companies. Drugmakers can accept the prices or negotiate with CMS before a final price is set by Sept. 1, according to an agency timeline. CMS has promised to use several factors to calculate the prices, such as whether the product has a therapeutic equivalent and the overall research and development costs. But during a call with reporters Wednesday evening, Biden administration officials declined to say how much savings the initial price offers would generate. A previous estimate showed that, between June, 2022 and May, 2023, the 10 drugs cost the federal government $50.5 billion. Biden has touted drug price negotiations to help lower health care costs for Americans as one of his signature domestic achievements since entering the White House. Democrats had pushed unsuccessfully for years to add drug price negotiation power to Medicare. “Americans pay far too much for prescription drugs. Many struggle to pay for their medication as a result,” HHS Secretary Xavier Becerra said during the call. WELCOME TO THURSDAY PULSE. At long last, my Dry January concludes! While I can’t say I saw immediate health benefits (definitely immediate financial benefits), I’m intrigued by how quitting alcohol may have improved my gut health. Send your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_. Public Health Sen. Tim Kaine told the audience at a POLITICO Live event Wednesday that he expects bipartisan health legislation to be included in an upcoming spending package. | Rod Lamkey Jr. for POLITICO ALZHEIMER’S PROGRAM RENEWAL ON THE WAY — A bipartisan effort is underway to combine two legislative priorities — reforming pharmacy benefit manager operations and boosting the health care workforce — into one health care package, POLITICO’s Daniel Payne reports. Sen. Tim Kaine (D-Va.), in an interview at the “How Fast Can We Solve Alzheimer’s” POLITICO Live event Wednesday evening, said the Senate Health, Education, Labor and Pensions Committee members are looking to combine both issues that they’ve been working on in recent months. In that larger package, he said, would be room for other health policies, including a reauthorization of the BOLD Infrastructure for Alzheimer’s Act, which bolstered research and care for people with Alzheimer’s disease. “It could easily be part of this package,” he said. “I’ll certainly push that it should be part of it.” It isn’t just the Senate that has a plan for reauthorizing the program. The bill has been reintroduced in the House, and Rep. Brett Guthrie (R-Ky.), who also spoke at the event, said there’s a sense of urgency to get it — and other big programs — reauthorized. “I think you’ll see in the very near future it [as] part of a legislative hearing,” Guthrie said. Congress is just weeks away from needing another spending package to keep the government open — and many see that package as an opportunity to get health legislation of all kinds across the finish line. “We need to do it,” Kaine said. Meanwhile: Read our five takeaways from the event.   CONGRESS OVERDRIVE: Since day one, POLITICO has been laser-focused on Capitol Hill, serving up the juiciest Congress coverage. Now, we’re upping our game to ensure you’re up to speed and in the know on every tasty morsel and newsy nugget from inside the Capitol Dome, around the clock. Wake up, read Playbook AM, get up to speed at midday with our Playbook PM halftime report, and fuel your nightly conversations with Inside Congress in the evening. Plus, never miss a beat with buzzy, real-time updates throughout the day via our Inside Congress Live feature. Learn more and subscribe here.     In Congress Family members hold photographs of children allegedly harmed by social media during a Senate Judiciary Committee hearing Wednesday. | Francis Chung/POLITICO HOW TO KEEP KIDS SAFE ONLINE — Lawmakers are stuck on how to force social media companies to do more to protect kids from mental health harms when using their platforms, POLITICO’s Ruth Reader reports. Senators from both sides of the aisle committed to holding the companies accountable Wednesday during a Judiciary Committee hearing with social media CEOs. But, a law to stop social media sites from recommending material that could harm kids — the Kids Online Safety Act, or KOSA — hasn’t been brought to the Senate floor for a vote. Though it has 46 Senate co-sponsors — 24 Republicans and 22 Democrats — Senate Majority Leader Chuck Schumer is waiting for more backing from lawmakers, according to a spokesperson. The support: Lawmakers are concerned about youth mental health. Thirty percent of teen girls seriously considered suicide in 2021, according to the CDC’s most recent youth risk behavior survey. Even some tech executives back the law, including the CEOs of LinkedIn, Snap and X, formerly known as Twitter. The concerns: Some Democrats are wary of moving forward with legislation that Democratic constituency groups oppose, including the American Civil Liberties Union and dozens of LGBTQ+ advocacy groups. In 2022, the groups wrote to lawmakers, saying KOSA would force social media companies “to use invasive filtering and monitoring tools; jeopardizing private, secure communications; incentivizing increased data collection on children and adults; and undermining the delivery of critical services to minors.” What’s next? Lawmakers are open to some compromise, such as on the enforcement aspect of the bill. At the Agencies MA RATE RAISE — Medicare Advantage rates could increase next year under a CMS proposal released Wednesday — but it doesn’t go as far in tackling overpayments as some liberal lawmakers had hoped, Robert reports. The CMS proposal would raise rates by 3.7 percent in 2025, giving plans an extra $16 billion compared with this year. The insurance industry had anxiously awaited the update, as some of the biggest Medicare Advantage providers have recently told Wall Street that their business is struggling. PANDEMIC PRESCRIBING MADE PERMANENT — HHS made a pandemic-era flexibility permanent Wednesday: The agency finalized rules that will allow providers to prescribe buprenorphine — a treatment for opioid use disorder — through telehealth without an in-person visit, POLITICO’s Carmen Paun and Ben report. The Substance Abuse and Mental Health Services Administration said the rule, which applies only to certified opioid treatment programs, makes drug therapy more accessible. Why it matters: The opioid epidemic continues to ravage the country, with more than 100,000 fatal drug overdoses annually. What’s inside the rule: It allows for buprenorphine prescribing through audio-only telehealth; gives providers in opioid treatment programs more flexibility to decide when to give their patients methadone to take at home; and eliminates outdated words like “detoxification” to avoid stigmatization, among other changes. What’s next? The rules go into effect on April 2, and the compliance date is April 2, 2026. DEA is working on proposed rules for virtual prescribing of controlled substances like buprenorphine after 2024 when eased pandemic rules expire. It’s unclear when those will be proposed, but DEA has said it will finalize them by the fall. CPAP RECALL UPDATE — Since the FDA began investigating the breakdown of foam in Philips Respironics medical devices, it has received thousands of reports from consumers, Chelsea writes. Background: Philips pulled millions of sleep devices, including CPAP machines and ventilators, from shelves in June 2021 after it became known that the foam used in the devices to cut down sound and vibration can break down and be inhaled by patients. On Wednesday, the FDA said it received more than 7,000 medical device reports, including 111 reports of death, between July 1 and September 30, 2023 — as part of the 116,000 medical device reports and 561 deaths reported since April 2021. Company spokesperson Elco van Groningen told Pulse in an email that Philips investigates all complaints, and based on its investigations, “Philips Respironics has found no conclusive data linking these devices and the deaths reported.” He added that the number of complaints is “not typically but rather directly correlated to the increased awareness” from the recall. The investigation update comes after the company said Monday it wouldn’t sell new continuous positive airway pressure or bilevel positive airway pressure sleep therapy devices in the U.S. until it meets certain terms of a consent decree with the Department of Justice, David reports. WHAT WE'RE READING The Wall Street Journal reports on the financial fall of DNA testing company 23andMe. POLITICO’s Lauren Gardner reports on Biogen ceasing production of landmark Alzheimer’s drug Aduhelm. STAT reports on undiagnosed reversible liver disease in some dementia patients.   DON’T MISS POLITICO’S GOVERNORS SUMMIT: Join POLITICO on Feb. 22 to dive into how Governors are wielding immense power. While Washington remains gridlocked, governors are at the center of landmark decisions in AI and tech, economic development, infrastructure, housing, reproductive health and energy. How are they setting the stage for the future of American politics, policies and priorities? How are they confronting major challenges? Explore these questions and more at the 2024 Governors Summit. REGISTER HERE.       Follow us on Twitter Dan Goldberg @dancgoldberg Chelsea Cirruzzo @chelseacirruzzo Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM 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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