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The Health 202

A newsletter briefing on the health-care policy debate in Washington.

Robert Califf needs Republicans to help confirm him as FDA commissioner

The Health 202

A newsletter briefing on the health-care policy debate in Washington.

Good Monday morning — today we're soliciting your best Thanksgiving recipes, especially anything pumpkin pie-related. Send us all the dish at rachel.roubein@washpost.com.

Below: A controversial, pricey Alzheimer's drug is partially to blame for a large hike in Medicare premiums, and Biden's social spending bill could be up for a vote this week. But first:

Some Democrats aren't keen on Califf

The Senate will again consider Robert Califf to lead the Food and Drug Administration. But his nomination is already facing resistance from a handful of Democrats who opposed his Obama-era confirmation. 

On Friday, President Biden chose Califf to serve as FDA commissioner, ending a months-long search to pick a permanent leader for the beleaguered agency worn down by the pandemic. Several Democratic senators — such as Sen. Joe Manchin (D-W.Va.) — were quick to express reservations over Califf’s ties to the drug industry and the FDA’s record on cracking down on addictive opioids.

Still, that won’t tank his nomination. In a statement, Biden pointed to Califf’s bipartisan support back in 2016, when he was easily confirmed in an 89-to-4 vote to helm the agency during the last year of the Obama administration. 

What that means: Califf will almost certainly need GOP votes again. Five years ago, many Republicans viewed him as a skilled scientist who wasn’t hostile to the drug industry, our colleague Laurie McGinley reports. 

  • The résumé: Califf is a cardiologist and a researcher known for his expertise in clinical trials. Before leading the agency, he did a year-long stint as deputy commissioner for medical products and tobacco. Since leaving the government, he’s advised Google Health and its spinoff, Verily Life Sciences.
  • The reaction: “Many FDA experts welcomed the nomination, seeing Califf as an experienced hand who is unlikely to make abrupt changes as the agency navigates a tumultuous period,” Laurie writes.

A word from Manchin:

Manchin vs. White House

The most forceful concerns Friday came from Manchin and Sen. Richard Blumenthal (D-Conn.), who were among just four senators to vote against Califf in 2016. Sen. Ed Markey (D-Mass) and former Sen. Kelly Ayotte (R-N.H.) also opposed his nomination, while Sen. Bernie Sanders (I-Vt.) missed the vote. 

  • Manchin said he outright opposes Biden’s FDA pick. “Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backward not forward.”
  • Blumenthal said he has the same “grave reservations” as before. Back then, the senator argued the FDA lacked adequate opioid oversight and didn’t believe Califf brought a fresh perspective to the issue.
  • However, 65 of the 89 senators who originally voted for Califf as FDA commissioner are still serving in the chamber, per an analysis from The Post’s Dan Diamond.

The White House sought to tamp down concerns, expressing confidence that he would be confirmed. 

  • “We feel he’s a qualified person who has the exact experience for this moment,” press secretary Jen Psaki said.
Lay of the (Senate) land

The Senate HELP Committee is charged with holding a hearing on Califf’s nomination and advancing it to a vote before the full chamber. 

It’s unclear how quickly that will happen. The panel expects to receive Califf’s nomination referral this week, according to a committee aide, who said the panel “looks forward to scheduling a hearing on his nomination as soon as possible.”

  • Califf received support Friday from Sen. Patty Murray (D-Wash.). She chairs the panel and said she “look[s] forward to working with him.”
  • Sen. Richard Burr (R-N.C.), the HELP committee's ranking member, previously voted for the nominee. He praised Califf’s “unwavering commitment to patients as a respected clinician, researcher and adviser” during a confirmation hearing in 2015.
  • Burr hasn’t yet said where he stands this time around. Califf, a longtime Duke University researcher, has ties to the senator’s home state, though Burr wasn’t consulted by the White House on the pick, according to a Burr spokesperson.

During his nomination hearing, Califf will likely face tough questions from a few key senators. In the past, Califf has consulted for several pharmaceutical firms and, since 2014, received more than $93,000 in consulting fees and travel and lodging expenses, Laurie notes, citing the federal government’s Open Payments database.

  • Sen. Maggie Hassan (D-N.H.) conveyed concern Friday over the FDA’s record on opioids, but didn’t specifically call out qualms with Califf. (A spokesperson declined to comment on how the senator would vote.)
  • Sanders had expressed opposition to Califf during the Obama years, saying he “was not convinced that he would stand up to the greed of the pharmaceutical industry.” (A spokesperson didn’t comment.)

Politico's David Lim:

Agency alert

Big hike in Medicare premiums partially due to pricey Alzheimer’s drug

Seniors will see a roughly 14.5 percent increase in their monthly premiums for outpatient care, as the administration weighs whether to cover a new Alzheimer’s treatment that would have a massive impact on Medicare’s finances.

  • The standard premium for Medicare Part B will be $170.10 for 2022, compared to the $148.50 per month this year, the Centers for Medicare and Medicaid Services announced Friday. 
  • Over the summer, the Medicare Board of Trustees estimated premiums would be $158.50, a much smaller increase.
  • For comparison’s sake: Premiums rose $3.90 from 2020 to 2021. They increased $9.10 from 2019 to 2020.

Why the substantial hike? 

  • Congress limited how much premiums could increase last year due to the pandemic.
  • The agency is also preparing in case it decides to cover the Alzheimer’s drug. The FDA approved the drug over the summer, though some experts say there’s scant evidence that it works. The treatment from drugmaker Biogen costs $56,000 annually per patient.

CMS contends seniors won’t feel the impact of the spike due to a 5.9 percent cost-of-living adjustment in their Social Security benefits. Meanwhile, one top Democrat — House Energy and Commerce Chairman Frank Pallone Jr. (D-N.J.) — is already using the hike to make the case for the party’s drug pricing ambitions. 

Most restrictions on nursing home visits are lifted

Federal regulators lifted restrictions on visits to nursing homes, citing widespread vaccinations that have helped protect residents, The Post’s Meryl Kornfield reports. The change comes after CMS restricted visits back in spring 2020 due to rising coronavirus cases. 

  • According to the new memo, facilities should allow indoor visitation at all times and for all residents, and should no longer limit the length or frequency of these visits. The agency still cautioned about risks from gathering and warned that staff vaccination rates remain lower than residents’ rates.

On the Hill

The House’s big test: The chamber is eyeing a vote on the $1.75 trillion economic package this week. It’s a crucial moment for Democrats, who would need to put aside their intraparty divisions to advance Biden’s legislative agenda.

  • Earlier this month, progressives agreed to pass Biden’s bipartisan infrastructure deal. The compromise: Moderates said they’d vote for the economic package — which includes key Democratic health priorities — this week, provided the bill is shown to not add to the deficit.
  • Still waiting: Congressional scorekeepers haven’t yet released a full accounting of the bill’s cost, though more estimates could be released this week. Noticeably absent so far are projections on the health-care provisions.
  • How quick could the Senate pass the bill? In a letter Sunday, Majority Leader Chuck Schumer (D-N.Y.) said the chamber is working to ensure the policies meet the requirements of a budgetary maneuver Democrats are using to pass the bill without any GOP votes. And Schumer is already telling House Democrats he wants to get it through the Senate as soon as possible, our newsletter pals at The Early report this morning.

Rep. Josh Gottheimer (D-N.J.)

Coronavirus

In case you missed it:

  • In interviews with congressional investigators, six current and former health officials detailed Trump administration inference with efforts by the Centers for Disease Control and Prevention last year to issue warnings and guidance about the evolving coronavirus pandemic, The Post’s Dan Diamond reports. The new information, which includes statements from former CDC senior health expert Nancy Messonnier and then-White House coronavirus coordinator Deborah Birx, confirms prior reporting and offers additional details about the pandemic response at the highest levels of government.
  • A federal appeals court on Friday halted Biden’s vaccine or testing requirement for private businesses, The Post’s Eli Rosenberg and Ann E. Marimow report. A three-judge panel of the U.S. Court of Appeals for the 5th Circuit issued the ruling after temporarily halting the policy last weekend.
  • The Oklahoma National Guard has rejected the Defense Department’s requirement for all service members to receive a coronavirus vaccine, The Post’s Alex Horton and Dan Lamonthe report.
  • California and New Mexico have joined Colorado in expanding booster eligibility to all adults, even though federal health officials have so far only greenlit the extra shots for the elderly and other high risk groups, The Associated Press’s Don Thompson reports.

Daybook

Tomorrow: In a process known as a judicial lottery, all the challenges to Biden’s vaccine and testing requirement for private businesses will be consolidated in front of one court, randomly selected from among those currently considering challenges.

Thursday: The FDA will be in federal district court facing anti-tobacco groups who say the agency has moved too slowly to limit menthol in tobacco products. The FDA’s efforts to decide which e-cigarettes can stay on the market may force it to speed up its timeline for considering menthol tobacco products and could present an early challenge for Califf, Politico reports. 

TBD: We’re keeping an eye on the FDA, which received an application last week from Pfizer to expand booster shots to all adults. The agency may make a decision on that without input from its advisory committee.

Tune in Wednesday: We’ve got two Washington Post live events on health equity. One focuses on maternal and child health. The other will focus on cancer outcomes from a health equity lens.

Sugar rush

Thanks for reading! See y'all tomorrow.

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