With help from Lauren Gardner and Katherine Ellen Foley
Programming note: We’ll be off this Monday for Memorial Day but will be back in your inboxes on Tuesday.
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— A House panel is pressing health plans about covering birth control.
— CMS is bolstering hospital oversight amid high Covid-19 transmission.
— Califf’s slew of congressional hearings is over for now, but baby formula questions are only growing.
FIRST IN PULSE: HOUSE PANEL LAUNCHES BIRTH CONTROL PROBE — The House Committee on Oversight and Reform late Thursday dispatched letters to nine of the largest pharmacy benefit managers and insurers questioning whether they readily provide birth control at no cost to patients, a requirement established in the Affordable Care Act.
In letters to top executives of Express Scripts, Cigna, Aetna, CVS, Anthem, Optum Rx, Humana, UnitedHealth and Prime Therapeutics, Oversight Chair Carolyn Maloney (D-N.Y.) wrote, “Information obtained by the Committee suggests that plans and issuers may not be fully complying with the ACA’s requirements, potentially depriving enrollees of access to critically important reproductive health care.”
The committee cited research showing plans weren’t covering contraceptives without cost-sharing or omitting associated costs — like office visits and device insertion — under the no-costs umbrella. The ACA also requires that plans provide a clear exceptions process for when patients are denied coverage, but only 2 in 42 assessed plans do so.
A timely moment. With the overturn of Roe v. Wade looming, advocates have pushed for more accessible and low-cost contraceptive options and even over-the-counter birth control pills.
“I am deeply troubled by reports that health plans and issuers may not be fully complying with the ACA’s requirement to cover contraceptives at no cost, potentially depriving patients of access to critically important reproductive health care,” Maloney said in a statement.
The companies have until June 9 to answer a range of committee questions, including which contraceptive options are excluded from their formularies and how many included options were FDA approved after 2011.
CMS QUESTIONS HOSPITAL COVID TRANSMISSION — The Centers for Medicare and Medicaid Services is investigating hospitals where many patients have contracted Covid-19 infections after cases spiked to record highs this year, our Rachael Levy reports.
Jon Blum, the agency’s principal deputy administrator and chief operating officer, told POLITICO on Wednesday that the regulator is focusing on facilities with Covid outbreaks, taking into account patient and health workers’ safety complaints, a change from the agency’s “less rigorous” process early in the pandemic.
“We have really pivoted to a world where we are going to be surveying and holding facilities compliant,” Blum said. But he also declined to say how many hospitals have been cited for lax Covid precautions, citing “ongoing activities.”
CMS is asking Congress for more funds to meet these surveying efforts. Blum said congressional funding earlier in the pandemic strengthened the agency’s process, and he was hopeful that Congress would approve its budget request after the White House recently called for improved patient safety.
Blum said the agency won’t publicize facilities’ transmission rates. However, he said, the agency will publish online facilities’ staff vaccination rates this fall, which may help consumers determine a hospital’s risk.
Hospitals supply the Department of Health and Human Services with data about suspected infections acquired during their patients’ stays. In January, during the Omicron surge, more than 3,000 patients were infected with Covid each week, a record high for the pandemic, Rachael found in an analysis of those figures.
CALIFF COMPLETES HILL OVERSIGHT ONSLAUGHT — Thursday’s hearing marked FDA Commissioner Robert Califf’s third appearance on Capitol Hill in one week to explain the FDA’s response to the baby formula crisis, Lauren writes.
All eyes on the mailroom: Several senators in the HELP Committee took Califf to task for the FDA’s Wednesday testimony before the House Energy and Commerce Oversight Subcommittee, when he disclosed that senior agency officials didn’t promptly receive the whistleblower complaint due to “mailroom issues.”
The mailroom issue “was downplayed today,” committee member Sen. Richard Burr (R-N.C.) told Lauren. “It’s hard to run from statements that you’ve made before, especially when they’re 24 hours old.”
Abbott’s not ready: Califf insisted that Abbott has a long list of items to take care of before it can reopen the plant, contradicting an executive’s testimony Wednesday that the company would be ready “the first week of June.”
Where to lay blame: Califf said he doesn’t think firing people — or “castigating” agency employees — over the issue is “necessarily the solution to a problem like this.”
Still, he insisted he’s intent on reforming the agency. “I wouldn’t have come back if I wasn’t planning on changing it,” Califf said.
Biden’s support continues: When asked whether President Joe Biden still has confidence in FDA and Califf, White House press secretary Karine Jean-Pierre said Thursday: “Yes, yes and yes.”
HHS ENDS THE SUNSET RULE — The Biden administration is formally withdrawing a Trump-era rule after delaying its implementation twice.
The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule would have set a 10-year clock on thousands of health regulations, requiring agencies to periodically review them and rescind, amend or extend the policies. Nearly 3,000 rules would have been up for review in the first year alone.
Background: The Trump administration proposed the rule in early November 2020, just barely making the cutoff for a rule to be finalized before former President Donald Trump’s term ended. Biden health officials almost immediately proposed repealing the rule but opted to delay its implementation amid litigation.
Killing the rule would save nearly $70 million over 10 years and “reduce the time spent by [HHS] performing retrospective assessments and reviews of its regulations” as well as the time outside groups like nongovernmental organizations and state officials spend on assessing and providing input on expiring rules, HHS said in a document published to the Federal Register.
CDC DISPATCHES MONKEYPOX TESTS — The Centers for Disease Control and Prevention is sending supplies for monkeypox testing to at least seven states that have suspected cases, marking the latest escalation in the ongoing efforts to respond to infections in the U.S. and around the world, POLITICO’s Daniel Payne and Carmen Paun report.
The CDC is investigating nine potential cases, sending samples to labs for confirmation and a better understanding of the virus’ genetic makeup, officials said during a Thursday briefing.
Officials said it’s too early to know when the outbreak might end but noted that the last monkeypox outbreak, several years ago, didn’t lead to the virus becoming endemic as it did in some other countries.
Several countries have experienced unusual outbreaks of the virus in recent weeks. But public officials have stressed that the disease is rarely fatal and the number of cases is still relatively low — especially compared to widespread diseases like Covid-19.
NOVAVAX CONFIDENT COVID-19 SHOT WILL GET FDA GREEN-LIGHT — Novavax executives said in a press conference Thursday that they have high hopes for its two-dose Covid-19 vaccine for adults, which the FDA’s advisory committee will discuss on June 7.
The protein-based vaccine would be the first of its kind authorized in the U.S. In late-stage clinical trials, it reduced Covid-19 infection by roughly 90 percent — although those trials concluded before Omicron and its subvariants began circulating, Katherine writes.
Company executives believe the vaccine will be an alternative for those hesitant to receive an mRNA vaccine and can serve as additional booster doses. But Novavax has also been plagued by early concerns in the Biden administration that it could assure consistent, quality vaccine batches.
THE SUBSIDY CLIFF, BY THE NUMBERS — If Congress doesn’t extend or cement Affordable Care Act subsidies enacted during the pandemic, low-income Americans could see their monthly insurance costs double or even triple by year’s end, according to a Center on Budget Policy and Priorities report released Thursday.
For example: A single person making $30,000 a year would see their monthly premium more than double from $82 to $192, an annual jump of $1,320, writes Gideon Lukens, who is the center’s director of research and data analysis. Families would see some of the worst surges right around the midterm elections. Some states, like West Virginia and Wyoming, would see rates soar even higher.
The Office of the Assistant Secretary for Health has tapped B. Kaye Hayes to be Deputy Assistant Secretary for Infectious Disease and the Director of the Office of Infectious Disease and HIV/AIDS Policy. Hayes has served as acting director for the infectious disease office since September 2020 and previously served as acting deputy director and senior policy adviser for the Office on Women’s Health. Hayes also worked as an adviser for former Surgeon General and Assistant Secretary for Health David Satcher.
Judith Solomon is retiring after 17 years with the Center on Budget and Policy Priorities, where she was most recently a senior fellow focused on the Medicaid program. Solomon wrote on Twitter that she will continue to do some consulting.
Jillian Souza has joined Altria, the parent company of Juul and Philip Morris USA, as senior director for federal government affairs. Souza most recently served as chief of staff to former Rep. Devin Nunes (R-Calif.).
Stacey Johnston will chair the board of The College of Healthcare Information Management Executives’ Association for Executives in Healthcare Information Applications. Johnston currently serves as vice president and chief application officer for Baptist Health and is coming to the board to focus its efforts on data, CHIME said.
Sen. Burr has said he wants to delay the FDA user fee reauthorization amid the baby formula crisis. BioCentury’s Steve Usdin explores the possibilities.
There’s a nationwide shortage of dyes used in diagnostic imaging, delaying answers on patients’ cancers and other conditions, The New York Times’ Reed Abelson writes.
Health officials need comprehensive and timely data to fight the opioid crisis “without a blindfold,” National Institute on Drug Abuse Director Nora Volkow and NIDA’s Redonna Chandler and Jennifer Villani write.