|
Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | | |  | | By Sarah Owermohle and Adam Cancryn | | | With David Lim and Alice Miranda Ollstein PROGRAMMING NOTE: Morning Pulse will not publish on Monday, Oct. 11. We'll be back on our normal schedule on Tuesday, Oct. 12. Please continue to follow Pro Health Care. Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro. | | | — President Joe Biden has yet another critical health care role to fill, after Francis Collins announced he would step down as National Institutes of Health director. — The administration is clashing in public and private with a group of prominent health experts over its Covid-19 booster strategy. — Sen. Joe Manchin's insistence on including the Hyde amendment in Democrats' social spending bill has confused his colleagues. WELCOME TO WEDNESDAY PULSE — where it’s the end of an era: Joanne Kenen, who built out POLITICO’s health care team, hired and mentored countless journalists (including both PULSE authors) and led its coverage of every health policy debate across three administrations, is ending her decade-long run. It’s also the start of a new chapter: She’ll be a Journalist in Residence and faculty member at Johns Hopkins, as well as a contributing editor for POLITICO. Send tips and Joanne-isms to sowermohle@politico.com and acancryn@politico.com. | | | | A message from PhRMA: Some in Congress are considering a plan that would tie medicine prices in Medicare to those in the U.S. Department of Veterans Affairs. This misguided approach is just the latest in a series of government price-setting proposals that threaten patients’ access to medicines and future innovation. Read the five reasons tying Medicare Part D prices to the VA misses the mark. | | | | | | FINDING THE NEXT FRANCIS COLLINS — The longtime National Institutes of Health director is a rare Washington figure who transcended presidential administrations and congressional power shifts. Now, President Joe Biden needs to find him again. The search for a new leader for the world’s largest medical research agency creates another huge challenge while the White House plots the next phase of the pandemic response and struggles to find a nominee to lead the Food and Drug Administration. “We find ourselves in a deficit now: We have the largest health agency in the world, the NIH, without a leader and FDA at the same time,” said Ellen Sigal, who has chaired the Public–Private Partnerships Committee of the Foundation for the NIH and is the founder of Friends of Cancer Research. It’s not just about defending the administration’s pandemic response. Collins has appeared before Congress countless times to discuss Covid-19 origins, critical NIH research and Biden’s multibillion-dollar priority, the Advanced Research Projects Agency for Health — a proposed institute that still needs congressional backing. This has been in the works. Collins visited his longtime friend and colleague Anthony Fauci last winter and said he felt it was his time to leave. “I literally pleaded with him not to do that,” Fauci told POLITICO. It was during a Covid-19 case surge and the final months of the Trump presidency. “I said … ‘You’ve got to stick it out.’ He did. To his credit, he felt he owed it to the institution to make sure that there was stability.” What’s next: Outside experts say this could be a great time to reenergize institutes and assure lawmakers that ARPA-H will break the mold set by more than two dozen existing institutes. “It's probably a good time to have a rethink of the agency,” said Ezekiel Emanuel, a University of Pennsylvania bioethicist who spent 12 years at NIH. The White House says it expects to select Collins’ replacement before he leaves by the end of the year. | | | | Registration is OPEN for Breakthrough Summit 2021, the most important rare disease conference of the year! On Oct. 18 and 19, the National Organization for Rare Disorders will host the virtual Rare Disease and Orphan Products Breakthrough Summit. The Summit brings together the rare disease community from across the globe, including experts from patient advocacy, government, industry, media and academia, to discuss the current and critical topics in rare diseases. For access to two days of networking and dynamic programming on topics including drug pricing, genetic testing, Covid-19, equity and inclusivity, REGISTER NOW. | | | | | BEHIND BIDEN’S PUBLIC HEALTH DIVIDE ON BOOSTERS — The Biden administration’s push to widely distribute Covid-19 boosters is running into resistance within the public health community — including some top experts it’s relied on to sell the broader vaccination campaign. That was apparent during a private White House call last week, where several prominent doctors and scientists objected to the administration’s approach, people familiar with the matter told POLITICO’s Erin Banco and Adam. The health experts argued that current vaccine data doesn’t justify giving additional doses to most Americans during what one person on the call called a “very tense” discussion. That was at sharp odds with top Biden official Anthony Fauci, who countered the boosters should be given widely in hopes of cutting down on all cases — not just severe disease and death. The episode highlights a growing split between Biden’s team and the outside health experts who have served as key sources of support for the pandemic response. Until now, Biden’s “follow the science” approach had won near-universal praise from the public health community. But the booster effort — and the White House’s shaky handling of its rollout — has worried even those who believe most Americans should get another dose, yet think the Biden administration has mishandled the process. An HHS spokesperson said the administration regularly talks with outside stakeholders and is “doing all we can to offer Americans the maximum protection afforded by vaccines.” But the cracks in the Biden-public health alliance are showing at a critical time for the administration. Over the next month, officials could face thorny decisions on Moderna and Johnson & Johnson boosters, vaccines for children and whether getting shots of two different vaccines is safe. FIRST IN PULSE: ADMIN GOES BIG ON AT-HOME TESTS — The White House will announce today that the nation’s supply of at-home Covid-19 tests is on track to triple by early November, driven by recent government investments and the FDA’s emergency authorization of a test from ACON Laboratories. A White House official told POLITICO’s David Lim the administration is purchasing another $1 billion of at-home tests that will contribute to a quadrupling of the market to 200 million tests per month in December. “There will not just be more tests on the market, but we expect much more affordable tests on the market,” the White House official said. The supply of rapid at-home Covid-19 tests has struggled to keep up with demand driven by the Delta variant, and many retail pharmacies have placed limits on the number customers can buy. The administration is also working to double the number of pharmacies participating in the government’s free testing program — which is expected to surpass 10,000 stores in the coming weeks — to 20,000 locations. The White House ultimately hopes to have 30,000 free testing sites running nationwide, including community-based testing locations. | | | |   | | | | | | MANCHIN’S ABORTION FUNDING STANCE PERPLEXES DEMS — Sen. Joe Manchin’s (D-W.Va.) insistence that the Hyde amendment be imposed on the Medicaid gap piece of Democrats’ social spending package has baffled his colleagues in the House and Senate, who say the longstanding ban on federal funding for abortion is already current law, POLITICO’s Alice Miranda Ollstein reports. “That’s a distraction,” Sen. Raphael Warnock (D-Ga.), the lead sponsor of the Medicaid policy in the Senate, told reporters Tuesday. “My Medicaid bill will do the same thing that Medicaid does now. It’ll just open it up to more people.” Senate Finance Chair Ron Wyden (D-Ore.) agreed, adding that he’s “not in favor of what Sen. Manchin is trying to do.” Manchin’s demand has thrilled anti-abortion groups like Susan B. Anthony List, whichalso contend that a new federal program covering people in states that haven’t expanded Medicaid needs to have Hyde language attached. But lawmakers and analysts disagree. New programs still need to go through an appropriations process, and “Congress hasn’t passed a budget without [the restriction] since Henry Hyde came up with it in the ‘70s,” Kaiser Family Foundation’s Alina Salganicoff said. Democratic aides add that the move is not only unnecessary, but could run afoul of the Senate reconciliation rules that similarly prevented Republicans from attaching an abortion funding ban on their Obamacare repeal bill in 2017. Manchin didn’t respond to questions about his Hyde amendment position. | | | CMMI CHIEF TALKS DRUG PRICING, MANDATORY MODELS — CMS' Innovation Center is poised to implement new drug pricing models but is waiting on what Congress may do with the price negotiation bill currently stalled by Democratic caucus divides, CMMI Director Elizabeth Fowler said in a Tuesday Alliance for Health Policy briefing. “It's been challenging to think about drug pricing while Congress is debating drug pricing legislation,” Fowler told reporters. “There's no new idea that you could bring this team that hasn't already been thought of before … I think we need to see what happens in Congress and then we stand ready to look down the road of pricing models if the time is right.” She also toed the line on implementing more mandatory models through CMMI. People who participate in those experiments “are those that are more likely to succeed, or those who are more likely to have the resources to participate, and so we're not capturing a certain segment of the provider community,” Fowler said. But that doesn’t mean a storm of new required programs. “If we do mandatory models, they need to be thought out very carefully in the context of the rest of our strategy," she added. | | | UNITEDHEALTH MANDATES VACCINATIONS — UnitedHealth, one of the nation’s largest health care companies, is the latest to require that its front-facing employees get vaccinated against Covid-19. The company announced Tuesday it will give workers who provide care for patients until Nov. 30 to complete their vaccination series. That includes those who meet in person with customers, members, providers or suppliers, as well as those who enter UnitedHealth’s facilities. | | | | TELL US WHAT YOU THINK: Do you listen to POLITICO podcasts? We want to hear from you! Tell us what you like, what you could do without, and what you want to see in the future from the POLITICO Audio team! Your responses will help us improve our offerings and tailor our podcast content to better fit your needs. Find the survey here. | | | | | | | | HEALTH CHALLENGES IN WOMEN, CHILDREN GROWING — Rising maternal mortality and drug deaths are among the worrying measures on the rise for women in recent years, according to a new analysis of the nation’s health from the United Health Foundation. The Health of Women and Children report found maternal mortality rose by 16 percent between 2018 and 2019. Drug deaths among women also jumped by nearly a quarter in the 2017–2019 period, compared with 2014–2016. And mental distress overall rose as well, with roughly 18 percent of women in 2019 reporting poor mental health for at least 14 of the past 30 days before the survey. There are warning signs for children, too. The teen suicide rate increased across all racial and ethnic groups, while 9 percent of kids reported having anxiety in the 2019–2020 period — up from 7.5 percent in 2017–2018. “Across many measures, the report found persistent and widespread disparities that affect American women and children based on their geography, race/ethnicity, educational attainment and income level,” the report concluded. | | | For Barron’s, Josh Nathan Kazis argues that access to Merck’s Covid-19 antiviral pill could be limited over safety concerns tied to the way the drug attacks the virus. Keeping infected children out of school in hopes of limiting Covid-19’s spread may be doing more harm than good, Jeffrey Vergales and Monica Gandhi write in The Washington Post. In rural areas throughout the country, the Delta surge put providers’ telehealth services to the test, STAT’s Katie Palmer reports. | | | | A message from PhRMA: Some in Congress are considering a plan that would tie medicine prices in Medicare to those in the U.S. Department of Veterans Affairs. This misguided approach is just the latest in a series of government price-setting proposals that threaten patients’ access to medicines and future innovation.
Here are five reasons why the VA is a wrong model for Medicare:
1. Unlike Medicare Part D, the VA uses a one-size-fits-all system that restricts access to medicines.
2. The majority of VA beneficiaries rely on other sources to help supplement their drug coverage, including Medicare Part D.
3. The VA relies on quality-adjusted life year (QALY)-based assessments to set prices for medicines.
4. Imposing the VA system on Medicare is wildly unpopular with seniors.
5. Comparisons between Medicare Part D and the VA fail to acknowledge inherent structural distinctions between the two programs.
More. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
