Congress released an end of the year omnibus

Congressional negotiators released a $1.7 trillion budget deal to fund the federal government for the remainder of the fiscal year and avert a looming government shutdown. The bill includes $120.7 billion for the Department of Health and Human Services, a $9.9 billion increase over fiscal year 2022. Lawmakers have until midnight on Friday to pass the deal.

FDA requested independent report urges major reforms, including breaking up the agency over formula crisis

Following the infant formula crisis earlier this year, the FDA requested that an independent panel review the FDA’s Human Foods Program, including its culture, structure, leadership, resources, and authorities. The review found that the program was in a state of constant turmoil that hampered its ability to respond to the formula crisis. Among the suggestions that the panel had was that HHS should have separate food and drug administrations, which would elevate the visibility of both sides of the agency and separate their budgets. Experts have long pointed to the FDA’s food oversight work as being chronically understaffed and underfunded, along with consistent poor leadership.

HHS released a report on Long-COVID

HHS released the Health+ Long COVID Report, a human-centered design for Long COVID that seeks to co-create patient-centered solutions with people impacted by the condition. The report was generated by researchers conducting over a thousand hours of interviews and four workshops with people who are or were affected by Long COVID, including caregivers and practitioners. The report explores how and why the effects of long COVID, which can range from mild to severely debilitating, differ from person to person. It also notes that various social determinants of health influences how it affects the life of each patient.

FDA: Only 5% of COVID-19 clinical trials produced quality evidence

FDA Principal Deputy Commissioner Janet Woodcock said that only about 5 percent of Covid-19 clinical trials aimed at identifying or developing treatments were rigorous enough to produce quality evidence. “We hardly got any evidence … because it was every person for themselves setting up these little, as I call them, small crappy trials,” Woodcock said. She added that researchers struggled because they were competing for patients. The longtime FDA regulator said efforts to make clinical trials more affordable, expand the use of remote access to trials and increase the use of platform trials, in which researchers compare multiple intervention groups with one control group, are needed.

Congress rolls back COVID-19 vaccine mandate in the military

Congress passed the National Defense Authorization Act, which provides annual authorization for the Department of Defense. As part of negotiations, Republicans demanded and won the removal of the COVID-19 vaccine mandate for all military personnel. Military recruits are still required to have between 9 and 17 other vaccinations.

House Committee on the Coronavirus Crisis released final report

The Select Subcommittee on the Coronavirus Crisis, chaired by Rep. James E. Clyburn, released its final report on December 9. The report includes 30 recommendations to strengthen the nation’s ability to prevent and respond to public health and economic emergencies. These recommendations include: accelerating development of next-generation coronavirus vaccines and therapeutics; investing in improved financial relief and public health infrastructure; combating misinformation; and protecting relief programs from fraud. The report also reveals information about how the Trump Administration’s failure to prepare for the threat led to insufficient personal protective equipment (PPE) and results from investigations in purveyors of coronavirus misinformation.

CMS seeks to tighten restrictions on marketing Medicare Advantage plans

CMS has issued a proposed rule that would institute technical changes to Medicare Advantage and Medicare Prescription Drug Benefit Programs. The rule would restrict marketing by banning any commercials that don’t mention a specific plan name, as well as ads that use confusing words, images and logos. The rule would also increase access to behavioral health services in Advantage networks, streamline the prior authorization process, and improve drug affordability.

House Republicans call for preventing Medicare payment cuts to providers

The House GOP Doctors Caucus urged House leader to tackle looming cuts to Medicare payments to health care providers in year-end legislation. “We are concerned that severe, impending reductions to Medicare payments will result in hiring freezes, elimination of services provided to seniors, and decreased patient access to health care services…we are particularly concerned about the impact of Medicare cuts in rural and underserved communities.,” the letter, signed by 83 House Republicans, says.

ASPE finds that Medicaid Programs are turning to doula services for maternal care

State Medicaid programs are increasingly turning to doula services to help tackle the maternal health crisis, but low reimbursement rates may risk undercutting tangible progress. Medicaid programs in at least 15 states plus the District of Columbia have implemented doula services or are in the process of doing so. ASPE found that doula-assisted mothers were four times less likely to give birth to a baby with low birth weight, two times less likely to experience a birth complication involving themselves or their baby, and significantly more likely to initiate breastfeeding.” Access to doula services has been historically limited in the U.S., with greater utilization among higher-income individuals, since doula services are often not reimbursed by health coverage programs including most state Medicaid programs.

What I’m reading

The Washington Post found that nearly 90 percent of COVID-19 deaths are now in people 65 or older, the highest rate ever. While many policymakers seek to think of the pandemic as over, epidemiologists and demographers predict the trend of older, sicker and poorer people dying at disproportionate rates will continue, raising hard questions about the trade-offs Americans are making in pursuit of normalcy — and at whose expense.

Wage stagnation and worker burnout is happening across sectors and countries. More than 70,000 academics and staff members at 150 United Kingdom universities began the largest strike in the history of higher education on November 24, in protest against poor pay, unsustainable working conditions and pension cuts. Researchers have pointed to poor working conditions as eroding the future of scientific work.

Locally owned and operated community hospitals are facing difficult dilemmas as they face critical budget constraints, as they consider allowing larger systems to take over their operations, which means cuts to staff and services, or to close entirely. The US health care system puts small, locally controlled hospitals at a disadvantage. Revenue is based almost entirely on the volume of medical services a hospital provides and, by their very nature, hospitals serving rural or otherwise remote communities do not see as many patients. Scott at Vox investigated several case studies on the challenges these medical centers face.

Ranney wrote in CNN about the sudden shortages in common pediatric medications, including antibiotics. The supply chain constraints are more significant than a rise in influenza cases as the FDA has identified over 120 medications that are either unavailable or in short supply in the US. Despite the best efforts to address root causes, we still have a dysfunctional, opaque medical supply chain. There is still no easy way to scale up production to meet excess demand. And there remains a limited profit motive to do better, particularly for low-cost medications such as amoxicillin. When an ingredient goes into short supply, when demand increases (either because of real increases in demand or because of perceived need due to media coverage), when workers get sick or when a single manufacturer goes down — the system falls apart.

Rasolt wrote in Undark about the lessons that Brazil can give when it abruptly shifted from investments in research and innovation to almost eliminating investments and actively undermining education under President Jair Bolsonaro to the cautious optimism of the newly elected President Luiz Inácio “Lula” da Silva returning to power. In addition to Bolsonaro cutting investments by 90%, widespread disinformation campaigns brought anti-scientific ideologies into the mainstream, cementing distrust of science and education across large swaths of the population. This destructive process has overtly played out over the last four years in Brazil under Bolsonaro, as it has in many other parts of the world, including, of course, the United States.

The Agency for Healthcare Research and Quality (AHRQ) released a report on diagnostic errors in emergency departments, and found that nearly 6 percent of the 130 million people going into an emergency room each year are misdiagnosed, leading to 2.6 million preventable harms a year. Of those preventable harms, 370,000 are either permanently disabling or lead to the death of the patient. Over two-thirds of serious harms are attributable to just 15 diseases and linked to cognitive errors, particularly in cases with "atypical" manifestations. Scalable solutions to enhance bedside diagnostic processes are needed, and these should target the most commonly misdiagnosed clinical presentations of key diseases causing serious harms.  

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