NIH Director Francis Collins to step down

From: POLITICO Pulse - Tuesday Oct 05,2021 02:04 pm
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Quick Fix

— Francis Collins, NIH Director for three presidents, will resign today according to sources familiar.

Democrats begin again with trillions of dollars in social priorities even as progressives say they’ve already compromised enough.

HHS finalized a rule reversing Trump’s abortion funding limit that saw a fifth of providers quit the program.


WELCOME TO TUESDAY PULSE. Lasers aren’t just for distracting cats anymore. Send tips and your favorite fat bears 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.

 
Driving the Day

COLLINS TO RESIGNThe National Institutes of Health Director plans to announce his resignation after nearly three decades at the agency, including 12 years at the helm, POLITICO scooped Monday.

The 71-year-old physician-geneticist led the agency under three consecutive presidents — making him the first presidentially appointed NIH director to serve in more than one administration and the longest-serving NIH director, Megan Wilson, Sarah and Erin Banco write.

During the coronavirus pandemic, Collins has been on the front lines urging Americans to wear masks and get vaccinated. While the public criticized other top health officials, accusing them of partisan behavior in the coronavirus response, Collins often presented a calm and friendly face on TV shows and airwaves.

Collins, who led the global effort to sequence the human genome and discovered the gene for cystic fibrosis, has spoken at length about his conversion from atheism to Christianity. In 2006 he penned a book in 2006 called “The Language of God: A Scientist Presents Evidence for Belief.” A year later, he founded the BioLogos Foundation, a group that aims to reconcile religion and science.

His departure had been in the works for some time, one person familiar said. Officials from NIH, the Department of Health and Human Services and the White House did not immediately respond to requests for comment.

What’s next: It’s not clear who will take Collins’ place, especially during a critical time for NIH research, pandemic response and new ventures like the multibillion-dollar Advanced Research Project Agency for Health. Principal Deputy Director Lawrence Tabak could become acting director, but in the meantime the White House adds another high-profile health appointment to its list alongside FDA director.


DEMOCRATS BEGIN THE BARGAINING (AGAIN) — While an agreement on the multitrillion-dollar social spending package remains elusive, Democratic leaders publicly admit it won’t be $3.5 trillion.

What now: It may end up in the range of $1.9 to $2.3 trillion, less than half of the $6 trillion progressives initially sought, POLITICO’s Marianne LeVine, Burgess Everett, and Sarah Ferris report.

And yet, Senate progressives are still split over whether they’re willing to accept a smaller package. Despite Biden telling Democrats his proposed range last week, Sen. Bernie Sanders (I-Vt.) reiterated that $3.5 trillion was already a compromise, while Sen. Elizabeth Warren (D-Mass.) noted the Senate already agreed to a $3.5 trillion budget blueprint in August.

“It's time for [Senate Majority Leader Chuck] Schumer to bring them in and try to get to a number,” said Sen. Jon Tester (D-Mont.), referring to Sens. Kyrsten Sinema (D-Ariz.) and Joe Manchin (D-W.Va.). “Chuck has to do that. He has to bring them in … Nobody can do it except him because anything that we agree on doesn't matter.”

How it happens: Biden in a Friday meeting on the Hill pushed Democrats to think of ways to limit key policies, such as “means-testing” certain proposals and imposing income-based limits. Progressives are opposed to those limits, but moderates aren’t making it easier.

Sinema on Saturday blasted Democratic leadership for delaying the vote on the physical infrastructure package — which progressives refuse to back without a vote on social spending. But critics — including a brutal cold open on ‘Saturday Night Live ’ this weekend — argue the Arizona senator hasn’t sent out clear priorities to move the ball forward.

Sinema has said she privately shared her priorities with Biden and Schumer, but most of her colleagues don’t know exactly where she stands, Marianne, Burgess and Sarah write.

Meanwhile: Outside groups are trying to save their top priorities. The advocacy coalition Southerners for Medicaid Expansion is sending a series of handwritten letters to Biden from low-income people in states that have yet to expand Medicaid, pleading for him to prioritize closing the coverage gap as part of the reconciliation package.

BIDEN REVERSES TRUMP ABORTION LIMIT — The administration Monday released a final rule scrapping a Trump-era regulation that barred abortion providers from receiving federal funds and banned all grantees from making abortion referrals.

The new policy, first proposed in April, largely returns the Title X federal family planning program to the way it ran for decades before 2019, POLITICO’s Alice Miranda Ollstein writes. But there are some updates, including a requirement that service sites offer "culturally and linguistically appropriate, inclusive, trauma-informed" family planning care, which HHS Assistant Secretary for Health Rachel Levine said is an attempt to help the program better serve people of color and others who have been historically underserved.

The rule will officially take effect on Nov. 8. Hundreds of clinics operated by Planned Parenthood and other providers who left the program will be able to rejoin then, while others will have to wait until early next year.

The number of people served by the program plummeted after the Trump administration imposed its version of the rule. More than 20 percent of grantees quit rather than comply, including scores of Planned Parenthood clinics and several health state departments, resulting in at least 844,000 fewer patients served.

 

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RICHARD NEAL BLASTS ADMIN’S ‘SURPRISE’ BILLING REG — House Ways and Means Chair Richard Neal (D-Mass.) rebuked the Biden administration over its latest rule implementing a ban on “surprise” medical bills, warning the regulations “do not reflect the law that Congress passed.”

In a letter sent Monday by Neal and top Ways and Means Republican Kevin Brady (R-Texas), the two accused the administration of straying from the statute when it created a process for resolving payment disputes between providers and insurers.

Under the new rule, arbiters must determine the payment for a procedure based on the median in-network rate, and deviate from that only when one side can offer a clear rationale.

That rule has infuriated providers who argue it tips the scale in favor of insurance companies — an argument echoed by Neal and Brady, who contend the law Congress passed required arbiters to consider a range of factors without giving preference or priority to any one of them.

“Such a standard affronts the provisions enacted into law, and we are concerned that this approach biases the IDR entity toward one factor (a median rate),” the two wrote in the letter to HHS Secretary Xavier Becerra, Treasury Secretary Janet Yellen and Labor Secretary Marty Walsh, which was later obtained by PULSE.

Neal and Brady added that they want the administration to send them additional written justification for how the rule’s pay-dispute language is in line with the law.

NEW COVID TEST COULD DOUBLE SUPPLYA newly authorized at-home Covid-19 test could dramatically expand rapid-test availability in the U.S., a top FDA regulator and White House spokesperson said Monday.

The FDA’s emergency authorization of Flowflex, made by San Diego-based ACON Laboratories, comes as a surge in new infections driven by the Delta variant has forced retail pharmacies to limit the number of rapid tests customers can buy, POLITICO’s David Lim writes.

ACON Laboratories is expected to be able to manufacture more than 100 million at-home tests a month by year’s end, according to the FDA. Production capacity is anticipated to rise to 200 million a month by February.

What’s next: Association of Public Health Laboratories CEO Scott Becker described the new authorization as a “really good surprise,” but argued the Biden administration must do more to educate the public on the role of at-home tests.

“It’s great to have the tools, but there also needs to be a companion PSA or some other public information that talks about when to use them, how to use them and what to do with the results,” Becker said.

 

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Names in the News

HHS SEES COVID TEAM DEPARTURES — Carlo de Notaristefani, the guru of Covid-19 vaccine production and manufacturing, has left the administration after working for 17 months on the team formerly known as Operation Warp Speed.

De Notaristefani joined the Trump administration in May 2020 to help the federal government find ways to scale the manufacturing and production of the Covid-19 vaccines. He worked alongside former Warp Speed leaders Moncef Slaoui and Gen. Gustave Perna. The Biden administration eventually changed the name of Operation Warp Speed to the Countermeasures Acceleration Group, or CAG.

Several additional CAG members, including Perna and other officials from the Department of Defense, left the team this summer, and it’s now fully under HHS leadership.

Meanwhile, Leslie Dach returned to his role as chair of Protect Our Care after a month-long stretch inside the health department, he told PULSE. Dach had joined HHS temporarily as a Covid-19 strategic planning director, where he aided messaging and policy coordination around the booster shot rollout, back-to-school procedures and preparations for children’s vaccines.

A former senior HHS aide in the Obama administration, Dach founded Protect Our Care to fight the Trump administration’s bid to repeal Obamacare. The group has since focused on aiding Biden’s health agenda, advocating particularly for lowering drug prices.

John Mix is the new chief marketing and development officer for Physicians for Human Rights. He most recently served in a similar position for Catholic Medical Mission Board Worldwide and was senior director of marketing at Human Rights Watch.

Emergent BioSolutions promoted Assal Hellmer to senior director for business communications, and Matt Hartwig to senior director for media relations. The Maryland biotech also promoted Katherine Getty to director for federal government affairs.

 

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What We're Reading

The Texas abortion ban is already complicating dire medical decisions, like a tragic moment when a doctor diagnosed anencephaly, a birth defect that’s always fatal, NPR’s Sarah McCammon writes.

About 17,000 Missourians have applied for Medicaid since August under expanded eligibility rules hashed out over the past year, the latest in what Democrats hope will entice more red states to Medicaid expansion, Kansas City Star’s Jeanne Kuang reports.

Former FDA Commissioner Scott Gottlieb told Reuters’ Julie Steenhuysen he believes the Delta variant will be the last big Covid-19 surge.

 

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.

 
 

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