The debt limit negotiations hang over all other policy
Talks continue between Speaker McCarthy and President Biden on Republican demands for raising the debt limit or triggering the first ever default in US history. Due to the complexity of Treasury payments and receipts, there is uncertainty about when the government runs out of funding authority and defaults, although experts point to the date being between June 1 and June 13. President Biden and congressional Democrats have called for a “clean” debt limit increase, i.e. without conditions, whereas Speaker McCarthy has called for the inclusion of numerous Republican priorities, including immediate budget cuts for nondefense discretionary accounts, budget caps for future appropriations, stricter filing processes for work requirements, and the repeal of most of the Inflation Reduction Act.
Congressional appropriators have paused their work as their bills will be dependent on any new limitations or caps on discretionary spending that comes from a debt limit deal. The House Appropriations Committee canceled scheduled markups on the four bills that they have released so far: Military Construction and Veterans Affairs; Agriculture, Rural Development, and the FDA; Homeland Security; and the Legislative Branch.
Nondefense discretionary accounts represent a small minority of all federal spending at less than one-sixth. AcademyHealth joined 761 other organizations in calling on Congress to reject cuts and limitations on nondefense discretionary spending and focus on investing in critical programs, from research to nutrition access, and more. Speaker McCarthy has called for cut discretionary spending back to FY22 levels and then increasing them by 1 percent per year. Adjusted for inflation and population growth, these caps would be a 58 percent cut for all programs by 2033. Budget caps are budget cuts, even if the caps grow over time.
Dr. Bertagnolli nominated for Director of NIH
President Biden has nominated Dr. Monica Bertagnolli, current Director of the National Cancer Institute (NCI), to be the Director of the National Institutes of Health (NIH). If confirmed by the Senate, Bertagnolli would be filling a role that’s been vacant for over a year. She would lead the country’s medical research agency, overseeing 27 research institutes and centers focused on different areas of medical research, such as cancer, the human genome, as well as allergy and infectious diseases. She would succeed Dr. Lawrence Tabak, who has been serving as acting NIH Director following the 2021 retirement of Dr. Francis Collins.
Federal appeals court pauses ruling against USPSTF
The U.S. Court of Appeals for the Fifth Circuit in New Orleans will put on hold a decision from March that had threatened insurance coverage for recommended services like depression screenings for teenagers and drugs that prevent transmission of H.I.V. The Justice Department had appealed the decision, and the appeals court’s stay will stand while the appeals process plays out. Earlier this year, Judge Reed O’Connor of the Federal District Court for the Northern District of Texas ruled that insurers did not have to cover any of the services that had been recommended by the United States Preventive Services Task Force since 2010. His reasoning: The task force is not appointed by Congress and therefore did not have the constitutional authority to decide what services a health insurer must cover.
Senators probing algorithmic denials in Medicare Advantage plans
Lawmakers in both parties have asked UnitedHealth Group, Humana, and CVS Health’s Aetna for internal documents that “will show how decisions are made to grant or deny access to care, including how they are using [artificial intelligence],” said Sen. Richard Blumenthal, the top Democrat on a subcommittee with the power to investigate government affairs. This oversight comes on the heels of a STAT investigation that found Medicare Advantage insurers are routinely relying on proprietary algorithms as a basis for denying care.
Green card freeze worsening nurse workforce crisis
The stream of international nurses coming to work in the United States could soon slow to a trickle because of a backlog of green card petitions at the State Department. The department announced in its May bulletin it moved the cut-off date for visa eligibility to June 1, 2022 — meaning only those who filed petitions before that date will be able to continue with their applications this fiscal year — because of soaring demand. Anyone who filed a green card petition in the past year, which could include thousands of nurses, won’t be able to proceed with their applications. Health groups say the move could devastate a nursing workforce that is plagued by staffing shortages in the aftermath of the Covid-19 pandemic.
Maternal Mental Health Hotline reporting 12k contacts in first year
The Health Resources and Services Administration (HRSA) debuted the toll-free hotline on Mother’s Day last year to help expecting or post-partum mothers struggling with their mental health. The number connects callers to counselors who provide “emotional support, resources, and referrals.” The hotline has been averaging approximately 1,000 contacts a month.
Senate HELP Committee moves on drug pricing bills
The Senate HELP Committee passed a package of bills aimed at speeding generic drug competition and reining in drug middlemen business practices. But they failed to pass an ambitious reform to the pharmacy benefit manager sector, despite strong bipartisan support for it. Chairman Bernie Sanders (I-Vt.) is pursuing the drug pricing reforms at the behest of Senate Majority Leader Chuck Schumer (D-N.Y.), who wants to hold a floor vote on an even bigger package of health bills later this year. The markup came just a day after the same panel held a major hearing on PBM and drugmakers’ role in high insulin prices.
Mifepristone case threatens to undermine the gold standard of drug approval processes
The legal battle over the Food and Drug Administration’s (FDA) approval of the abortion pill mifepristone could undermine a drug approval process considered to be the “gold standard” around the world. With oral arguments in the Texas lawsuit set to begin next week, the implications of how the 5th Circuit Court of Appeals rules are far-reaching. “The doors would be open for all sorts of plaintiffs to assert standing and could really make it very hard for the drug manufacturers who rely on the FDA’s final word on drugs,” Laurie Sobel, associate director of women’s health policy at the nonprofit KFF, told The Hill. The plaintiffs in this case are questioning the FDA’s scientific process for evaluating the benefits of drugs. According to the Alliance for Hippocratic Medicine, if the appeals court rules in favor of the plaintiffs, its effects will extend beyond abortion access: “a constant barrage of legal challenges to federal approval could discourage drugmakers from bringing new medications of all kinds to market.”
WHO calls for caution on AI due to bias and misinformation
The World Health Organization (WHO) is calling for caution to be exercised in using artificial intelligence (AI) generated large language model tools (LLMs) to protect and promote human well-being, human safety, and autonomy, and preserve public health. While WHO is enthusiastic about the appropriate use of technologies, including LLMs, to support health-care professionals, patients, researchers and scientists, there is concern that caution that would normally be exercised for any new technology is not being exercised consistently with LLMs. This includes widespread adherence to key values of transparency, inclusion, public engagement, expert supervision, and rigorous evaluation.
Senate HELP Committee will only advance HHS nominees committing to drug price cuts
Chairman Bernie Sanders informed the White House that he will strongly oppose any future nominee to a major federal health agency who is not prepared to significantly lower the price of prescription drugs in this country. The senator said that he has long-standing concerns that health leaders aren’t using all of the tools at their disposal, citing decisions at the Centers for Medicare and Medicaid Services, FDA and NIH. With the narrow Senate majority, Sen. Sanders opposition could prove definitive for nominees.
Fertility app Premom settles with FTC over risky data sharing
The company behind fertility app Premom has entered into a settlement with the Federal Trade Commission and attorneys general in Connecticut, D.C. and Oregon for allegedly sharing sensitive user information with third parties without receiving consent. Premom allegedly shared user identifiers — strings of numbers tied to individual devices — along with sensitive information such as locations with two China-based companies known for “suspect privacy practices.” This comes in a string of federal actions against digital health companies, which could mark shifting tides for an industry that until now has seen little oversight. The FTC called out digital prescription app GoodRx in February, proposing a ban on the app sharing users’ health data for advertising. And in March, mental health app BetterHelp settled with the FTC after allegedly sharing information about users’ mental health concerns with outside companies including Facebook and Snapchat. Both GoodRx and BetterHelp said at the time that the practices in question were common for the industry.
Clinical trials for mRNA universal flu vaccines begins
The National Institute of Allergy and Infectious Diseases Vaccine Research Center has started to enroll volunteers at the Duke University for its Phase 1 trial of the mRNA-based vaccine, which uses the same technology as the COVID-19 vaccines. The study will have 50 “healthy volunteers” ages 18 to 49 enrolled in the trial who will receive check ups up to one year after their vaccination. Currently, scientific experts predict which strains of the flu will be most prevalent in the country every year to determine which strains of the flu should be included in the vaccine. A universal flu vaccine would cover all the different kinds of strains of the influenza virus, as opposed to the seasonal flu vaccines on the market now.
FDA released draft guidance on generating more data on children
Drug companies should consider submitting their preliminary plans for testing therapies in children earlier than the FDA requires, the agency said. The FDA released a pair of draft guidance documents that aim to encourage drugmakers to generate more data on how well their drugs work in children, along with more safety and dosing information. Pediatricians frequently write off-label prescriptions because there isn’t enough information on how well medicines work for their patients. Most drugs haven’t been tested in children before they’re prescribed for them, according to the FDA.
What I’m reading
Two important new studies build on a generation of research into health disparities and inequity. In one study, researchers conclude that the gap in health outcomes translated into 80 million years of potential life lost — years of life that could have been preserved if the gap between Black and White mortality rates had been eliminated. The second report determined the price society pays for failing racial and ethnic health inequities: $421 billion in 2018 alone.
As the wildfire of state laws go into effect to limit or prohibit health care and health care access, more physicians are being forced to decide if they should stay where they are and possibly face discipline or criminal charges, or if they should leave the state. Dr. Suran wrote in JAMA about these challenges, where states like Idaho are considering criminalizing the administration of mRNA-derived vaccines, the closing of ob-gyn and labor and delivery facilities, and bans on gender-affirming care. This article includes interviews with 13 physicians, trainees, researchers, and legal experts on the legislative effects on health care.
I am excited to be following the “Building a Better NIH” project partnership. This project has eight different papers from a diverse group of scholars on possible paths forward for NIH. The agency is facing numerous challenges, such as an aging principle investigator pool, principle investigators spending almost half of their time on paperwork rather than active research, and the continued decline in disruptive papers being published.
A recent NIH-funded study found that children in poverty tend to have healthier brains and fewer mental health challenges if they live in states that have more generous social safety net programs. Weissman et al wrote in Nature that impoverished children tended to have smaller hippocampus regions in their brains, which is associated with memory and learning, than affluent children. However, in states with more robust welfare programs, the disparity was 34 percent narrower.
Noncitizens make up approximately 8 percent of the nonelderly population in the US, however they are expected to comprise nearly a third of the nation’s uninsured population in 2024, according to new research from the Urban Institute and Robert Wood Johnson Foundation. Two-thirds of uninsured noncitizen adults are ineligible for public health coverage based solely on their immigration status. They are also less likely to work in fields that provide health insurance as a benefit, with a third of non-citizens having employer coverage compared to 54 percent of all nonelderly people in the US.
The Supreme Court decision in Dobbs has led to wide-spread negative health outcomes for pregnant people. A new report by Grossman et al at the University of California at San Francisco identifies dozens of examples from providers of sub-standard and dangerous care that pregnant patients received because of the ruling. Patients are being harmed in significant ways because health care is being denied or delayed as a result of new abortion restrictions and bans.
According to the GAO, more than half of rural counties lack obstetric care. This reality prompted the Federal Office of Rural Health Policy, which is part of the Health Resources and Services Administration, to launch the Rural Maternity and Obstetrics Management Strategies Program, RMOMS. Ten regional efforts nationwide, have been awarded federal grants to spend on telehealth and creating networks of hospitals and clinics. This pilot program dramatically increased the access of health care for expectant mothers, but the funding is expected to run out in August. NPR discussed what that means in New Mexico.