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Presented by Blue Cross Blue Shield Association: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | | |  | | By Sarah Owermohle and Adam Cancryn | | | With help from Joanne Kenen 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. | | | — FDA is in a pickle with booster decisions after an expert panel bucked dispensing third doses to the broader population. — Top government scientists are doing cleanup, insisting this is in line with the administration’s plans and could evolve soon. — Sen. Sinema opposes the prescription drug plan throwing the latest roadblock onto the multitrillion-dollar reconciliation package. WELCOME TO MONDAY PULSE. One of your authors is a William & Mary alum contemplating crashing this commencement speech. Who knows, the other might, too. Send college guesses and tips to sowermohle@politico.com and acancryn@politico.com. | | A message from Blue Cross Blue Shield Association: Millions more Americans could gain access to high-quality health insurance coverage by expanding Medicaid. Let’s close the low-income coverage gap and create a more equitable health care system that works better for everyone. Learn how. | | | | | | THE BOOSTER FUTURE — FDA advisers upped the ante for an already complicated booster rollout with a vote Friday that made it clear: They don’t think the broader population needs a third vaccine just yet. The vaccine advisory panel voted unanimously to recommend a third dose of Pfizer and BioNTech’s vaccine for people 65 and older but went 16-2 against shelling it out to people above age 16. While FDA doesn’t have to follow its advisers’ recommendations, it generally does — except this time around is unlike any other. Today is the day that top health officials and President Joe Biden said that broad booster rollout would begin. That vaccine experts and some FDA regulators themselves don’t believe it’s the right time for most adults, throwing another wrench in the Biden administration’s vaccine messaging. What’s next: FDA could issue its label for the third vaccine by the time you read this. A separate CDC panel meets this week to outline parameters for administering the vaccine which — depending on FDA’s label — could involve defining who is high-risk and therefore should get the shot before others. Lauren Gardner writes that the FDA panel endorsed boosters for frontline health care workers in an unofficial straw poll Friday. Spotted: Here is a sentence we didn’t see writing in 2021 — Former Trump official Paul Alexander, ousted for trying to meddle with CDC reports on Covid risk, defended rapper Nicki Minaj’s viral vaccine comments. “People want to make this a joke and parody it, etc., but this is a very, very, serious consideration,” he said at the end of a public comment period, when he suggested that there was not enough safety data for coronavirus vaccines and fertility (there is no evidence that the shots impact fertility). A little more: Lauren is on the latest episode of POLITICO Dispatch with an inside at the contentious debate among federal health officials over booster shots — and why the advisory panel ultimately made its decision. | | | | 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. | | | | | COLLINS, FAUCI TALK BOOSTER DISSENT — The top NIH scientists hit the Sunday shows — four total — to argue that the FDA advisers’ vote is in line with the Biden administration’s booster plan and ever-evolving with the pandemic, Brianna Crummy writes. “It would surprise me if it does not become clear over the next few weeks that the administration of boosters may need to be enlarged based upon the data that we've already seen both in the U.S. and in Israel,” NIH Director Francis Collins said on “Fox News Sunday.” He added on CBS’ “Face the Nation” that the FDA’s guidance will evolve, as it should. “This is the way it ought to be. Science sort of playing out in a very transparent way, looking at the data coming from multiple places, our country, other countries, and trying to make the best decision for right now.” National Institute of Allergy and Infectious Diseases Director Anthony Fauci also made the case on NBC and ABC that the Friday vote is in line with Biden’s plan but that the “proper regimen” will include the original two shots plus a booster for everyone — eventually. “I believe that there's a good chance that as we get into the coming months, into the next year, that you will see the data pointing to the benefit of having a much broader blanket of people,” Biden’s chief medical adviser said on “Meet the Press.” SINEMA OPPOSES DRUG PRICING PLAN — Arizona Democrat Kyrsten Sinema is opposed to the current prescription drug pricing proposals in both the House and Senate bills, two sources familiar with her thinking told POLITICO’s Laura Barrón-López. Sinema also doesn’t back a pared-back alternative being pitched by House Democratic centrists that would limit the drugs subject to Medicare negotiation, they say. Sinema met with President Joe Biden on Sept. 15 to discuss the social spending package, in which party leaders hope to include the Medicare prescription drug pricing proposal. She’s made her resistance to the current House prescription drug negotiation proposal clear to the White House, according to one of the sources, but it’s unclear whether she’s immovable. It's the latest headache for the White House and Democratic leadership struggling to push through a $3.5 trillion package that both Sinema and Sen. Joe Manchin (D-W. Va.) have argued is too costly. The two senators met with Biden the same day. “As she committed, Kyrsten is working directly in good faith with her colleagues and President Biden on the proposed budget reconciliation package,” said John LaBombard, a Sinema spokesperson, who declined to discuss the prescription drug measure. “Given the size and scope of the proposal, while those discussions are ongoing we are not offering detailed comment on any one proposed piece of the package.” | | | |   | | | GOVERNORS RILED OVER BOOSTER CONFUSION — Federal public health officials are still wrestling with who should get Covid-19 booster shots and when. But state officials, absent a federal plan and facing down surges, are forging ahead, Lauren writes. Maryland Gov. Larry Hogan, a Republican, earlier this month issued executive orders authorizing booster doses for anyone 65 and older living in congregate settings like nursing homes and drug treatment centers. Last Monday, Colorado’s Democratic governor, Jared Polis, urged his state’s elderly residents to seek out third vaccine doses. The combination of aggressive state action and health experts’ pushback against Biden’s plan has amplified confusion about who needs boosters now. Some doctors are already recommending or administering boosters to patients outside of the small group of severely immunocompromised people who already qualify for the shots. “There’s been just a yoyoing of messages," said Clay Marsh, the head of West Virginia's Covid response. "We’re ready to go on the booster stuff as soon as we get the go-ahead,” West Virginia Gov. Jim Justice, a Republican, said Wednesday. The state is experiencing its worst surge yet, with no sign that new infections have begun to plateau or decline. HHS’ MONOCLONAL ANTIBODY POLICY DRAWS SENATE SCRUTINY — Alabama Sen. Tommy Tuberville is seeking more detail from HHS about its plan to control distribution of Covid-19 antibody treatments, warning it could slow shipments and penalize states most in need of the drugs. In a letter to HHS Secretary Xavier Becerra, Tuberville questioned the justification for the department reasserting authority over the treatments — and disputed concerns that rising demand from a handful of southern states would drive a shortage. “HHS and suppliers alike have assured my office that there is no supply issue, so the fundamental question is why HHS is now choosing to get involved,” he wrote. “In the days since this change was reported, my office has been inundated with pleas for help from providers whose [monoclonal antibody] orders were not fulfilled.” HHS imposed the new policy after seven states, including Alabama, accounted for 70 percent of all orders of the treatment in early September. The department will now allocate doses weekly to the entire country based on states’ caseloads and usage of the drug. | | | | SUBSCRIBE TO "THE RECAST" TODAY: Power is shifting in Washington and in communities across the country. More people are demanding a seat at the table, insisting that politics is personal and not all policy is equitable. The Recast is a twice-weekly newsletter that explores the changing power dynamics in Washington and breaks down how race and identity are recasting politics and policy in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | | | | | | FIRST IN PULSE: EXPERTS ARGUE FOR NEW CARE MODEL — Employer-sponsored health care is still falling short on costs, quality and fee-for-service care, the Duke-Margolis Center for Health Policy and JPMorgan Chase’s new health initiative argue in paper out today that argues for advanced primary care. The case: Duke-Margolis and Morgan Health lay out a framework for shifting to a per member, monthly payment model to improve care, curb medical complications and bake in transparency to bring down costs, Joanne Kenen writes. The model also includes virtual and home-based care, increasingly essential parts of the health ecosystem, particularly during the pandemic. The authors, which include former CMS administrator Mark McClellan and Morgan Health’s Dan Mendelson, argue the model can work with both large and small primary care practices in partnership with health plans, established comprehensive care providers or other parties. The problem — engaging people. Achieving “critical mass” of participating employers and providers to drive change is also difficult, even for large employers. Hear more: To hear more, tune in for a webinar at 3 p.m., with McClellan, Mendelson, CMMI’s Liz Fowler, and Avalere’s Elizabeth Carpenter. Joanne will be moderating. | | | The World Health Organization appointed former U.K. Prime Minister Gordon Brown as ambassador for global health financing. | | | Health care workers have been burned out — and it’s not getting better. HuffPost’s Brittany Wong spoke to ER doctors, mental health therapists, pharmacists and others about the never-ending struggle and how anti-vaxxers have worsened the plight. The pandemic isn’t ending, but full Covid coverage from insurers is. Most payers have reinstated co-pays and deductibles for coronavirus patients while reaping solid profits this year, The Washington Post’s Christopher Rowland reports. Energy & Commerce Chair Frank Pallone (D-N.J.) and ranking member Cathy McMorris Rodgers (R-Wash.) wrote to HHS Secretary Xavier Becerra backing a Medicare plan, instituted under former President Donald Trump, to penalize hospitals that aren’t transparent with prices. | | A message from Blue Cross Blue Shield Association: The racial health disparity crisis in the U.S. is unconscionable and unacceptable. That’s why Blue Cross and Blue Shield companies are working to reduce disparities in maternal health by 50% in 5 years – part of our multi-year commitment to promote health equity. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
