President Biden released his FY24 budget
President Biden released his FY24 budget, officially kicking off the congressional budget process for this fiscal year. Congress has until October 1 to pass appropriations to fund the government or trigger a government shut down. This year’s budget negotiations are happening under the shadow of the House Republican Majority insisting on as of yet undetermined spending cuts before they raise the debt limit. Even without these larger negotiations, this fiscal year will be more difficult for Congress with the chamber controls split with significantly different demands and priorities. This makes the President’s Budget a statement of priorities and values rather than an indicator of the final fiscal allocations.
The President’s Budget is calling for AHRQ to be funded at $447.5 million, an increase of $74 million, or 19.8 percent, over the FY23 enacted level of $373.5 million. This budget would call for significant increases in health service research, data, and dissemination with an additional $59 million investment, bringing this function up to $170 million. Other highlights include:
- $19 million to support health systems research on delivering patient-centered, coordinated care to those with Long COVID.
- $59 million in new and continuing investigator-initiated health services research funding to improve the performance of healthcare systems in producing high-quality care, including $3 million to advance health equity in healthcare delivery.
- $11 million in new research funding directed to revitalizing and reforming primary care.
- $10 million for research to prevent, identify, and provide integrated treatment for opioid and multiple substance abuse disorders in ambulatory care settings.
- $5 million to expand behavioral healthcare activities by supporting primary care practices in providing integrated care in under-resourced communities and with under-served populations.
- $7.4 million to support the Administration’s initiative to improve maternal healthcare.
- $2 million to establish Centers of Excellence in Telehealthcare Implementation. These centers will generate essential new evidence to understand access, equity, and quality issues that may inform policy decisions.
- $7.4 million to advance the Department of Health and Human Services (HHS) efforts to coordinate and align ongoing state-level efforts to develop all-payer claims databases to inform policymaking in the public and private sectors.
- $6.5 million increase to allow the U.S. Preventive Services Task Force to expand the number of clinical preventive services reviews in FY 2024, thereby increasing the number of final recommendations in future years and increasing transparency and patient engagement.
CMS ready to step in on Medicaid eligibility checks
The Centers for Medicare & Medicaid Services will “step in and stop” states that fail to follow agency guidance or aren’t properly prepared to handle the massive caseload of redeterminations, Jonathan Blum, principal deputy administrator and chief operating officer of the Center for Medicare & Medicaid Services, told lawyers at an American Health Law Association conference in Baltimore. Blum’s remarks come amid concerns by lawmakers and others that 15 million people nationwide could lose their Medicaid coverage—many due to procedural reasons—in the coming months. Eligibility checks had been halted during the Covid-19 pandemic, but Congress passed a provision late last year allowing them to resume.
FDA criticizes insurers for doing too little on drug research
Insurers must do more to help providers participate in clinical trials that can confirm the effectiveness of drugs granted accelerated approval, Food and Drug Administration Commissioner Robert Califf, M.D., told a room full of payer executives. Califf spoke about how to improve the accelerated approval process during a session at the AHIP 2023 Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. The remarks come as the FDA has new powers granted by Congress to get drug companies to finish trials for drugs after they reach the market via accelerated approval. “I am not aware of a major effort by insurance plans to help people get studies done,” Califf said. “What I am hearing from clinicians is that it is hard to do research in the current environment. There are negative incentives to do it.”
NCHS data finds that Covid worsened health outcomes among pregnant women
The National Center for Health Statistics reported that 1,205 pregnant women died in 2021, representing a 40 percent increase in maternal deaths compared with 2020, when there were 861 deaths, and a 60 percent increase compared with 2019, when there were 754. The count includes deaths of women who were pregnant or had been pregnant within the last 42 days, from any cause related to or aggravated by the pregnancy. A separate report by the Government Accountability Office has cited Covid as a contributing factor in at least 400 maternal deaths in 2021, accounting for much of the increase. Even before the pandemic, the United States had the highest maternal mortality rate of any industrialized nation. The coronavirus worsened an already dire situation, pushing the rate to 32.9 per 100,000 births in 2021 from 20.1 per 100,000 live births in 2019. The racial disparities have been particularly acute. The maternal mortality rate among Black women rose to 69.9 deaths per 100,000 live births in 2021, 2.6 times the rate among white women. From 2020 to 2021, mortality rates doubled among Native American and Alaska Native women who were pregnant or had given birth within the previous year, according to a study published on Thursday in Obstetrics & Gynecology.
Supply chain challenges lead to increased number of drug shortages, according to Senate report
Children's medication, antibiotics and treatment for ADHD are among a number of drugs that have been in short supply in recent months — and the shortages of critical medications are only rising. From 2021 to 2022, new drug shortages increased by nearly 30%, according to the report prepared by Democrats on the Senate Homeland Security and Governmental Affairs Committee. Shortages have been caused by economic drivers, reliance on foreign sources and poor visibility of the pharmaceutical supply chain, the report said. The committee report highlights that neither the federal government nor the pharmaceutical industry has the capability to assess the full supply chain, from the starting materials, to the finished dosage and to purchasers and providers. Many drug manufacturers have moved overseas over the last several decades because foreign governments have offered tax and logistical incentives as well as fewer regulations, the report said.
White House disbanding COVID-19 Response Team in May
The White House will shut down its covid response team after the public health emergency ends in May, with some staffers already departing and national coordinator Ashish Jha likely to leave the administration once his team is disbanded, according to multiple current and former officials who spoke on the condition of anonymity to describe internal operations. The move to disband the White House covid team, created in February 2020 and expanded to about three dozen staffers under President Biden, comes as the pandemic has receded from U.S. hospitals and in voters’ minds. The nation avoided a feared winter surge of virus deaths earlier this year, and while the Centers for Disease Control and Prevention still links about 2,000 deaths per week to covid, that represents the lowest death toll since the earliest days of the pandemic.
Moderna testifies to Senate HELP that they will quadruple price of COVID-19 vaccine
Moderna Inc's chief executive on defended the company's plan to quadruple the price of its COVID-19 vaccine, telling a U.S. Senate committee hearing it will no longer have the economies of scale from government procurement when the shots move into the private market. Moderna CEO Stephane Bancel was called to testify after the company flagged plans to raise the vaccine's price to as much as $130 per dose, drawing the ire of Democratic U.S. Senator Bernie Sanders, who chairs the influential Committee on Health, Education, Labor and Pensions (HELP). Sanders on Wednesday asked Bancel to reconsider the price hikes, saying they could make it unaffordable for millions of Americans and were unjustified given the government's research contributions and $1.7 billion in assistance in developing the vaccine.
ARPA-H building a procurement portfolio
Health technology vendors watching the government create a new research agency see a procurement portfolio nearing $700 million that’s come together over the last few months. A spate of recent solicitations and contract awards out of the Advanced Research Project Agency for Health signal the new agency, affiliated with the National Institutes of Health, is preparing to move from administrative planning stages to fulfilling its stated mission to be an early funder of high-impact health projects showing commercial potential. ARPA-H opened its first Agency-wide Open Broad Agency Announcement (BAA) seeking funding proposals for research aiming to improve health outcomes across patient populations, communities, diseases, and health conditions.
What I’m reading
As technology becomes a key, and sometimes necessary, component of engaging with providers and health systems, there is a risk of technologically adverse patients being left behind, creating telehealth disparities. The Mass General Brigham system is exploring the use of “digital access coordinators” to help train patients in digital health tools, such as electronic health records, registration forms, home blood pressure cuffs, and preparing for virtual visits and video calls. This program is part of the hospital system’s health equity effort, and in doing so they are recruiting these coordinators from the communities being served.
Mohottige et al wrote in JAMA about efforts to redress the harms cause by race-based equations delaying Black patients from getting onto kidney transplant lists. The US Organ Procurement and Transplantation Network (OPTN) has required transplant centers to modify the kidney transplant wait times for Black patients who might have been adversely affected. The authors discuss the need and options for additional work on eliminating racial biases in kidney function treatment.
Bernstein et al polled physicians and medical students about their practice location preferences in response to state abortion restrictions post-Dobbs. Of the 2,063 respondents, 82.3 percent of participants across all levels of training said that they would preferentially apply to states where abortion access is preserved. States that have abortion bans now are also more likely be currently facing significant physician shortages, and this research shows that recruitment efforts will be hampered. Given the dearth of research on the impact of changes in access to abortion care, the podcast, Crossing the Line, provides narrative stories from the "front lines."
Relatedly, an Idaho hospital has announced that it will stop delivering babies due to provider concerns over the criminalization of physicians and inability to retain pediatricians. Bonner General Health, the only hospital in Sandpoint, ID will no longer provide labor, delivery, and other obstetrical services, forcing residents to drive 46 miles for the nearest labor and delivery care. Finally, Dr. Simpson is a member of the new Standing Committee on Reproductive Health, Equity and Society at the National Academies of Science, Engineering, and Medicine. This initiative will evaluate the health, social, and economic implications of access to reproductive health care in the United States and globally.
It seems every day we are seeing new research and possibilities that are being driven by advances in AI. A new study that caught my eye used AI to recreate what people see by reading their brain scans. Many labs have used AI to read brain scans and re-create images a subject has recently seen, such as human faces and photos of landscapes. The new study marks the first time an AI algorithm called Stable Diffusion, developed by a German group and publicly released in 2022, has been used to do this. Using AI and fMRI data, researchers were able to recreate very convincing imitations of photos seen by study participants.
A cross-sectional study by Nguyen et al in JAMA found that female and Black principal investigators were significantly underrepresented among investigators holding 3 or more research project grants. These investigators are producing novel, impactful, and innovative research, yet remain significantly underrepresented among NIH investigators.
A survey of nurses in New Jersey found that nearly one-third of nurses in the state have left hospital bedside care due to workload and stress. If nothing changes, registered nurses will continue leaving, according to the survey, with 95% of RNs with no more than five years of experience seriously considering looking for a new job outside a hospital providing bedside care. The top two reasons given for leaving beside nursing were inadequate staffing levels (53%) and stress and burnout (51%).
The politicization of science and continued loss of trust in science continues to lead to dangerous legislation being considered in legislatures around the country. The Missouri House approved an anti-vaccination bill that would make all vaccinations optional, including in schools and workplaces that would no longer be able to require them.