At a Glance…
- Congress moves on a CR to avoid a shutdown
- CURES 2.0 facing an uncertain future
- FDA releases a report on their EUA process for COVID-19 tests
- And more…
Congress works to avoid government shutdown on October 1
Current federal funding runs out on September 30th as Congress has not passed any of the FY23 appropriations bills. They must pass a continuing resolution (CR) by then to avoid a government shutdown, which they are expected to do. The details of the CR are still being fiercely negotiated, including on subjects like the length of it, whether energy-permitting reform is included, additional Ukraine aid, an extension of the FDA user fee authorization, disaster aid for Puerto Rico, and other priorities.
The FDA Prescription Drug User Fee Act (PDUFA) expires on September 30th, and if it lapses the FDA would be forced to layoff thousands of employees as the fees fund roughly half of the FDA’s budget. There have been ongoing negotiations this year on a robust reauthorization and reform of PDUFA, which may proceed separately in December when the CR is expected to expire and Congress considers passing an omnibus funding and authorization bill. Current expectations are that a five-year extension of PDUFA will be included in the CR, leaving open the future of issues like regulations for diagnostics, dietary supplements, cosmetics, and other issues.
CURES 2.0 facing a rocky future
During what was likely the final House Energy and Commerce markup of the year, Rep. DeGette (D-CO) announced that her and retiring Rep. Upton (R-MI)’s CURES 2.0 legislation was supposed to have been marked up, but had to be pulled due to Republican Members threatening to offer “poison pill” amendments to the bill. The future of the bill remains in doubt as what was a broadly bipartisan bill gets tangled in partisan politics. Pieces of the legislation may be included in a December omnibus bill, but the likelihood of full passage this Congress dims. CURES 2.0 is a sweeping bill that would reform how the US conducts biomedical research, including provisions for speeding up the delivery of groundbreaking cures and the authorization for the Advanced Research Projects Agency for Health, or ARPA-H.
FDA Director Califf calls for more robust data and transparency
Commissioner Robert M. Califf is pushing the FDA to generate more robust data to defend its decisions following the release of a congressional report detailing attempts by top Trump administration officials to influence the agency’s pandemic response. Federal regulators “open the door for political or financially driven meddling when we don’t have the highest quality evidence for decision-making,” Califf said. The remarks come as the FDA is conducting an ongoing data modernization plan to better collect evidence that can be used to defend agency decision making. Califf has also made combating health misinformation a priority of his tenure, and said the FDA aims to work with outside partners to promote accurate information on Covid-19 vaccine and therapeutic decisions, as well as other regulatory actions.
Decades of underinvestment in public health data systems limited the effectiveness of government reactions to COVID-19 and increasingly to monkeypox. The federal government invested heavily over the past decade to modernize the data systems of private hospitals and health care providers, doling out more than $38 billion in incentives to shift to electronic health records. That has enabled doctors and health care systems to share information about patients much more efficiently. But while the private sector was modernizing its data operations, state and local health departments were largely left with the same fax machines, spreadsheets, emails and phone calls to communicate. States and localities need $7.84 billion for data modernization over the next five years, according to an estimate by the Council of State and Territorial Epidemiologists and other nonprofit groups. Another organization, the Healthcare Information and Management Systems Society, estimates those agencies need nearly $37 billion over the next decade.
ASPE released a roadmap for better incorporating mental health and substance abuse care
The Assistant Secretary for Planning and Evaluation (ASPE) at HHS released a roadmap for better incorporating mental health and substance abuse care in a coordinated way into the larger healthcare system. HHS has identified opportunities to build a more diverse workforce prepared to practice in integrated settings, even outside of traditional health care settings such as a hospital or clinic. HHS programs can help recruit, train, and support a diverse workforce capable of offering services that are fully integrated and culturally and linguistically appropriate. HHS has additionally identified opportunities for making this care more affordable for patients who are beneficiaries of government health insurance programs.
FDA Inspector General released a report on EUA for COVID-19 testing
The Office of the Inspector General of the FDA released a report on the Emergency Use Authorization (EUA) for the development and availability of COVID-19 tests, and found that the process led to less reliability in testing. They found that in using its EUA authority, FDA made calculated decisions to increase availability of COVID-19 testing, but these decisions often came at a potential cost to test quality. FDA authorized tests using lower levels of evidence to support developers struggling to access clinical samples. FDA's decision to accept all EUA requests resulted in a record number of submissions-often low-quality and from developers lacking experience with FDA's processes. The IG report recommended that FDA assess and revise its guidance for test EUA submissions, create templates for future emergency, and expand capacity, among other recommendations.
OSTP has a confirmed Director
The Senate voted to confirm Dr. Arati Prabhakar to lead the White House Office of Science and Technology Policy (OSTP) in a 56-40 vote. Dr. Prabhakar will be the first woman, immigrant, and person of color confirmed to lead the office. She will play a critical role in shaping biomedical research priorities, such as the Cancer Moonshot. She is expected to be officially sworn-in in the coming days.
House Committee released a report on preparing health care infrastructure for the climate crisis
The House Ways and Means Committee released a report that examines how the climate crisis impacts health care organizations and the climate impact and carbon footprint of health systems. All providers are vulnerable, and the time to prepare is now, rather than after operations have been compromised and residents of affected areas have nowhere to go for care. Failing to prepare health care systems and supply chains for extreme weather events has the potential to result in more death and suffering in the years ahead. And failing to establish the infrastructure and process to measure, track and reduce health sector GHG emissions will exacerbate and accelerate the climate impact on the health system.
Texas judge strikes down ACA requirements for preventative services without cost sharing
The Affordable Care Act (ACA) requires most individual and group health plans to cover preventive services, screenings, and vaccines without copayments coinsurance, or deductibles. This requirement benefitted almost 152 million people in 2020 and has led to increases in cancer screening and vaccinations, improved access to contraceptives, and earlier detection and treatment of chronic health conditions, like hypertension and diabetes. In a case filed by conservative groups, Texas federal court judge Reed O’Connor struck down these programs. He also found that the U.S. Preventive Services Task Force were not lawfully appointed under the Constitution because they were not nominated by the president and confirmed by the Senate; the USPSTF approved of nearly half of all of the recommended preventative services in the ACA. He also ruled that requiring plans to pay for HIV prevention drugs violates the Religious Freedom Restoration Act.
This ruling may lead to competitive health plans bringing back copays for preventative services. This could destabilize the health insurance markets as insurers would be able to design their preventative services to attract healthier people and discriminate against sicker ones. Experts have pointed to HIV prevention and contraception as services most likely to be targeted. The ruling is expected to be appealed.
What I’m reading:
Scholars and researchers are increasingly concerned about the implications of the Supreme Court’s anti-science rulings. Tollefson writes in Nature how recent rulings have all been underpinned by a rejection of substantial evidence on how the rulings would affect public health and safety. Wendy Parmet, who co-directs the Center for Health Policy and Law at Northeastern University in Boston, Massachusetts, was quoted saying: “In some cases they are elevating individual rights, and in others they are dismantling individual rights, but the through line is that they are dismissive of science and the real-world impact of their decisions.”
CDC released a report finding that more than 80% of pregnancy-related deaths were preventable, highlighting the importance of quality improvement initiatives to ensure that patients are getting the pregnant and postpartum care they need. Among pregnancy-related deaths with information on timing, 22% of deaths occurred during pregnancy, 25% occurred on the day of delivery or within 7 days after, and 53% occurred between 7 days to 1 year after pregnancy. Leading causes of death included mental health conditions (23%), excessive bleeding (14%), cardiac conditions (13%), infections (9%). Examples of prevention recommendations include wider access to insurance coverage to improve prenatal care initiation and follow-up after pregnancy, providing opportunities to prevent barriers to transportation to care, and the need for systems of referral and coordination.
Kane and Mandel wrote for the Progressive Policy Institute about the importance of better aligning incentives in combatting antimicrobial resistance (AMR) infections. The overuse of antibiotics and poor infection control during the height of the COVID-19 pandemic may have exacerbated the rise of AMR infections, which kill over 35,000 Americans a year. They call for policymakers to curtail the overuse of antimicrobials in medicine, limiting the use of antimicrobials in agriculture, and investing in the development of new antimicrobials.
Racial biases in practice and technology create health disparities that lead to far worse health outcomes for communities of color. Bhavani et al wrote in JAMA about how forehead temperature checks disproportionately miss fevers in Black patients, which lead to fewer notifications to health workers such as sepsis alerts to systematize timely triage and antibiotic administration.
Kimport wrote in Science that the Supreme Court’s Dobbs decision will lead to more criminalization of activities during pregnancy, more abortion denials, and more abortions after the first trimester. Following Dobbs, we can expect a dramatic increase in the surveillance and criminalization of activities during pregnancy and inequality in how that happens. In states that ban abortion, people whose pregnancies do not end with a live birth (including miscarriages, stillbirths, and abortions) are potentially suspect and at risk of civil and/or criminal penalties. Laws banning abortion will not affect only people seeking abortion; the increase in surveillance and criminalization will affect all pregnant people.