| | | | |  | | By Daniel Payne and Krista Mahr | | | With Ben Leonard, David Lim, Ruth Reader and Katherine Ellen Foley
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CMS Administrator Chiquita Brooks-LaSure told POLITICO health equity and affordability were the agency's priorities for the immediate future. | Chip Somodevilla/Getty Images | BROOKS-LASURE’S ‘BIGGEST CONCERN’ — On the 13th anniversary of the ACA being signed, the Biden administration is taking a victory lap on its efforts to boost the number of people enrolled through the law. CMS Administrator Chiquita Brooks-LaSure talked with Daniel about strategies she thought were successful to grow enrollment — as well as her “biggest concern” about future enrollment. What worked: Brooks-LaSure said outreach and subsidies were key to enrolling a record 16.4 million people. That included more focused media campaigns and getting more “trusted messengers” to help people sign up, particularly in underserved communities. The message was much more powerful, too, because of federal subsidies making plans cheaper, she said. The Inflation Reduction Act, passed by Congress last summer, extended through 2025 the subsidies put in place as part of the American Rescue Plan Act shortly after President Joe Biden took office. Biden has asked Congress to make the subsidies permanent, though that is unlikely with Republicans in control of the House. “There's a big difference in being able to say to people: four out of five people can find a plan for $10 or less,” she said. By way of comparison, about two-thirds of enrollees could find a similarly priced plan in 2020 under former President Donald Trump. The celebration – which included a fawning celebration of Rep. Nancy Pelosi (D-Calif.) on Wednesday – comes as the Biden administration could see the ranks of the uninsured spike. Congress last year passed a law to end a pandemic-era program that kept states from removing anyone from the Medicaid rolls. With eligibility being checked for the first time in three years, as many as 15 million Americans could lose their government-sponsored health insurance. While many qualify for Obamacare, public health experts are certain a sizable number will fall through the cracks, which could slow progress in the administration’s goal of having everyone covered. “Knowing that you need to transition … is, I would say, our biggest concern,” she said of people losing Medicaid coverage. On drug price negotiations: Drug makers, insurance companies and patient advocates want “to understand the rules of the road and understand what kind of data they're going to need to provide,” said Brooks-LaSure, adding that CMS is meeting its timeline for developing policy. WELCOME TO THURSDAY PULSE. Some fan bases are a little stranger than others, like the Beethoven fans who saved some of his hair — recently used to decode his DNA. We don’t take hair samples — but will take your tips about health! Drop us a line at dpayne@politico.com and kmahr@politico.com. TODAY ON OUR PULSE CHECK PODCAST, host Ruth Reader talks with Krista Mahr about flaws in CDC data that led the agency to overstate how many people received Covid shots, according to a new report by the Covid States Project, a collaboration of researchers from Northeastern, Harvard, Rutgers and Northwestern universities.
| | | | A message from PhRMA: What’s a pharmacy benefit manager (PBM)? They decide if medicines get covered and what people pay for them, regardless of what your doctor prescribes. These middlemen are putting their profits before your medicines. And getting between you and your doctor. You need to see what’s going on. | | | | | | | | | TALKING TIKTOK — The House Energy and Commerce Committee is expected to grill TikTok CEO Shou Chew this morning on his app’s potential damaging effects on children, Ruth reports. The background: The hearing comes amid the debate over social media’s link to mental health issues entering other realms, like the Biden administration and the courts. Since former Meta employee Frances Haugen revealed that the company was aware its platforms can negatively impact teen mental health, Congress has become increasingly interested in protecting children from social media. At a Senate Judiciary Committee hearing earlier this year, senators heard testimony about how platform algorithms are designed to addict children to staying online. Surgeon General Vivek Murthy has said he wants kids under 14 off social media, saying many of them get exposed to harmful content and bullying. And in a new strategy, some advocates are taking social media companies to court, trying to make them pay for alleged damages to children’s mental health. What else: And more action is expected in Congress. Sens. Ed Markey (D-Mass.) and Bill Cassidy (R-La.) are working on legislation to address the issue. “Here’s the reality: asserting that TikTok stands alone as the one platform that poses a serious surveillance threat to our nation’s youth is deliberately missing the Big Tech forest for the TikTok trees,” he said Wednesday on the Senate floor. “Big Tech is knowingly and willfully fueling a youth mental health crisis.”
| | | | DOWNLOAD THE POLITICO MOBILE APP: Stay up to speed with the newly updated POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need, reimagined. DOWNLOAD FOR iOS– DOWNLOAD FOR ANDROID. | | | | | | | | DEFENDING DECISIONS — HHS Secretary Xavier Becerra defended CMS’ decision surrounding Medicare coverage of Alzheimer’s disease treatments in testimony on the Hill, Ben reports. Lawmakers — mostly Republican — hit CMS for its decision not to cover Aduhelm outside of clinical trials. The FDA granted accelerated approval to the drug in 2021. CMS’ decision applied to the entire class of drugs, subsequently including Leqembi, which also received accelerated approval earlier this year. It could apply to future therapies. The agency said last month that it wasn’t going to reconsider the move, saying there wasn’t enough evidence to support doing so. In a Senate Appropriations subcommittee hearing, Sen. Susan Collins (R-Maine), ranking member of the full committee, as well as Labor-HHS subcommittee chair Shelley Moore Capito (R-W.Va.), laid into the agency’s decision. "CMS has all the evidence that it could possibly need,” Collins said, calling for more funding specifically for Alzheimer’s research. “CMS needs to stay in its lane.” Becerra defended the decision, saying the process the FDA uses is different from CMS’. “CMS has to remain consistent in the way it treats any drugs,” Becerra said. “As soon as they collect the evidence that lets them believe they can move to a different level or stage, they would.”
| | | | A message from PhRMA:   | | | | | | ADVISERS STOP SHORT OF ENDORSING BIOGEN’S ALS DRUG — The FDA’s expert panel on neurological drugs on Wednesday failed to find that available data on Biogen's amyotrophic lateral sclerosis drug candidate showed it would benefit patients, Katherine reports. The panel voted 3-5 with one abstention against recommending the drug's full approval at this time. Biogen conducted a Phase III clinical trial in which 108 participants were randomized to receive either the candidate, called tofersen, or a placebo. After 28 weeks, the trial had failed to slow ALS’ progression, according to multiple metrics. But when the company created an open-label extension of the trial in which all participants received the drug, there was some evidence that after a year the drug could slow the progression of the fatal disease. There was also evidence in both the Phase III trial and the open-label extension that tofersen reduced the concentration of a protein called neurofilament light chain in participants. The panel voted unanimously that the reduction of neurofilament light chain would likely correlate with future benefits of the drug. With this vote, the panel signaled that it believed tofersen could still be a good candidate for the agency's accelerated approval pathway, which allows drugs to come to market conditionally for serious diseases with unmet need. Biogen asked the FDA to grant tofersen accelerated approval last year. If the FDA gives it this conditional approval, the company must conduct an additional randomized trial to prove the drug benefits patients. The FDA doesn’t have to follow its panel’s advice, but it often does.
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Senate HELP Committee Chair Sen. Bernie Sanders, I-Vt., left, greets Moderna CEO and Director Stephane Bancel before Bancel's testimony to the committee on the price of the COVID-19 vaccine, Wednesday, March 22, 2023, on Capitol Hill in Washington. | Jacquelyn Martin/AP Photo | PROMISES MADE, PROMISES KEPT? — Moderna CEO Stéphane Bancel made the trek to Capitol Hill on Wednesday and sparred with senators over his company’s planned price hike for its Covid-19 vaccine, David reports. Senate HELP Chair Bernie Sanders (I-Vt.) argued that Moderna has a moral obligation to price its vaccine at an affordable level given the roughly $12 billion in taxpayer funds the company received to speed clinical trials and deliver its vaccine. “I cannot say that the price will be lower than other countries,” Bancel said when asked by Sanders whether the U.S. will pay higher prices for the company’s vaccine than other nations. The pharma executive maintained that the proposed $130 list price is in line with the shot’s value and that the company has fulfilled its obligations to the federal government. The role of the NIH: Sanders said he received a letter from the NIH on March 17 which asserts that three NIH scientists “are co-inventors” of Moderna’s vaccine and were “integral members of a collaborative team of scientists working to design and produce” it. But Bancel said that Moderna disagrees with the NIH assessment and is working within the rules of the U.S. intellectual property system.
| | | POLITICO’s Adam Cancryn and Lauren Egan report on the deteriorating relationship between Moderna and the White House. KHN reports on what to expect at the end of the Public Health Emergency.
| | | | A message from PhRMA: Insurers and their PBMs don’t want you to see that you could be paying more than they are for your medicines. Rebates and discounts can significantly lower what insurers and PBMs pay for medicines. These savings can reduce the cost of some brand medicines by 50% or more. But insurers and PBMs aren’t required to share those savings with you at the pharmacy counter.
They don’t want you to see that they use deductibles, coinsurance and other tactics to shift more costs on to you. Or that the three largest PBMs control 80% of the prescription drug market. Or that last year they blocked access to more than 1,150 medicines, including medicines that could have lowered costs for you at the pharmacy.
PBMs and insurance practices are shrouded in secrecy, they need to be held accountable. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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