Monday Report

David Ermer–ACA, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Fierce Healthcare lets us know,
    • “One week before President-elect Donald Trump’s inauguration, the Biden administration is finalizing a rule that sets new standards for the individual market under the Affordable Care Act.
    • “First proposed in October, the rule protects consumers from having their coverage swapped unwittingly. Brokers and agents that violate this policy, and pose other “unacceptable” risks, can be suspended. The rule will go into effect on Wednesday.
    • “The rule also amends the risk adjustment program through user fee rates, new calculations to the Basic Health Program (BHP) and reporting to the ACA Quality Improvement Strategy (QIS), designed to improve member outcomes.”
  • Here is a link to CMS’s fact sheet on the final Affordable Care Act (“ACA”) rule titled “HHS Notice of Benefit and Payment Parameters for 2026” and a link to the rule itself.
  • The ACA regulators today withdrew an October 28, 2024, proposed rule which would have “expand access to coverage of recommended preventive services without cost sharing in the commercial market, with a particular focus on reducing barriers to coverage of contraceptive services, including over the counter (OTC) contraceptives.”
  • FedSmith confirms,
    • “President-elect Donald Trump has nominated Scott Kupor as the Director of the Office of Personnel Management (OPM). 
    • “Kupor would lead an OPM organization that has grown under the Biden administration. It now has a larger budget and workforce. 
    • “For fiscal year 2025, the Biden administration proposed a budget of $465.8 million for OPM, which is an increase of about 21% compared to the enacted budget of $385.7 million in fiscal year 2023.”
  • The U.S. Office of Personnel Management posted on the Federal Register’s Public Inspection List a final rule which, according to Govexec, “will standardize the maps relied upon to determine the locality pay rates for white- and blue-collar federal workers across the U.S.” effective October 1, 2025.
  • Pew Research reports on what the data says about federal and postal workers.
  • Federal News Network notes,
    • “The Postal Service is offering early retirement buyouts to mail handlers who work in the agency’s mail processing facilities, and other USPS employees who work in a variety of support positions.
    • “USPS, in a memo obtained by Federal News Network, is offering lump-sum incentive payments worth up to $15,000 to eligible mail handlers who agree to a voluntary early retirement in the coming months.
    • “The agency reached an agreement with the National Postal Mail Handlers Union, which represents 47,000 mail handlers nationwide, as well as the American Postal Workers Union, which represents 222,000 active and retired postal clerks, mail processors and sorters, as well as other USPS occupations.
    • “Federal News Network reached out to both unions for comment.

From the judicial front,

  • The American Hospital Association News reports,
    • The U.S. Chamber of Commerce Jan. 13 filed a lawsuit against the Federal Trade Commission, saying changes made by the FTC to premerger notification rules under the Hart-Scott-Rodino Act are “unnecessary and unlawful.”
    • In a statement, the Chamber said the FTC “has failed to justify the need to subject every merger filing to its new burden. During the rulemaking process it never contemplated alternative, less burdensome approaches and understates the costs and overstates the benefits of changing the rule as part of its final analysis. Subjecting thousands of routine mergers and acquisitions to these additional burdens will slow down normal business transactions and increase costs, hurting the economy in the process.”
    • The FTC finalized changes to the premerger notification rules, form and instructions under the HSR Act in October. The AHA expressed disappointment with the FTC’s changes, saying that the rule “functions as little more than a tax on mergers… The agency already has more than enough information about hospital transactions, and it has shown no hesitation in challenging them. The final rule will just require hospitals to divert time and resources away from patient care towards needless compliance costs.

From the Food and Drug Administration front,

  • The Washington Post reports,
    • “The long quest for powerful non-opioid drugs that treat pain without risk of addiction is nearing a milestone, in the form of a pill that could soon win approval from the Food and Drug Administration.
    • “If successful, the drug developed by Vertex Pharmaceuticals would offer a possible alternative to potent prescription painkillers such as oxycodone, which was once heavily marketed by drug companies and fueled an epidemic of dependency and death.
    • “Independent experts say it remains too early to know how revolutionary the Vertex drug, suzetrigine, will be. The company’s application that is pending before the FDA, which could be approved by the end of January, is for relatively short-term pain. It is based on successful clinical trials in people recovering from two types of surgeries, as well as a safety study that monitored participants over about six weeks.
    • “Vertex is still exploring whether the drug can be safely and effectively used for chronic, longer-lasting pain.”
  • Cardiovascular Business points out,
    • “The U.S. Food and Drug Administration (FDA) has announced that Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry (MCOT) devices after certain high-risk electrocardiogram (ECG) events were never routed to trained cardiology technicians as intended. This is a Class I recall, the FDA’s most serious classification.
    • “This issue, which lasted from July 2022 to July 2024, has been associated with 109 patient injuries and two patient deaths. Some of the health events included suspected cases of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia and second- or third-degree atrioventricular block.
    • “On Dec. 18, 2024, Philips and its subsidiary, Braemar Manufacturing, sent all customers impacted by the failure an Urgent Medical Device Correction and information on how to review which patients may need to have their data reprocessed.”
  • and
    • “The U.S. Food and Drug Administration (FDA) has now cleared more than 1,000 clinical artificial intelligence (AI)algorithms to be used commercially for direct patient care in the United States. Cardiology is No. 2 among all healthcare specialties with 161 FDA clearances; some of those are even approved for multiple specialties.
    • “Radiology is by far the king of AI FDA clearances with 758 algorithms, making up about 76% of all clinical AI in the U.S. Neurology comes in at an extremely distant third place with 35 algorithms. There are 15 other specialities with cleared AI, but they each number less than 20 algorithms.
    • “The FDA updated its AI-enabled device approval list in late December, which showed the agency technically reached the 1,000 mark back in September. The first AI algorithm was cleared in 1996, and the number of submissions to the FDA has accelerated very rapidly in the past few years. The agency is now clearing an average of about 20 AI algorithms per month, and the FDA says that number is expected to rise in the coming years.”
  • Fierce Healthcare adds,
    • “The Peterson Health Technology Institute launched an artificial intelligence task force to puzzle out the value of in-demand AI technologies for healthcare delivery organizations.
    • “The task force has been operational for six months, Caroline Pearson, executive director of the PHTI, said in an interview. It will be led by Prabhjot Singh, M.D., Ph.D., a physician and co-founder of CHW Cares, which sold to Oak Street Health in 2022, and Margaret McKenna, former chief technology officer at Devoted Health. Both Singh and McKenna are advisers to the PHTI.
    • “There are about 60 people on the task force from a dozen healthcare systems, including UC San Diego Health, Intermountain Health, Mass General Brigham, Providence, Ochsner Health and MultiCare. Pearson also said there are many C-suite executives on the task force including CEOs, chief financial officer and chief information officers.
    • “They’re not AI cheerleaders,” Pearson said. “They’re just trying to run effective, efficient healthcare systems.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19 activity has increased in most areas of the country. Seasonal influenza activity remains elevated across the country. RSV activity is very high in many areas of the country, particularly in young children.
    • “COVID-19
      • “COVID-19 activity has increased in most areas of the country, with high COVID-19 wastewater levels, increasing emergency department visits and elevated laboratory percent positivity. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity is very high in many areas of the country, particularly in young children. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.”
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • Speaking of wastewater, the Your Local Epidemiologist newsletter, to which the FEHBlog subscribes, explains,
    • We’re seeing a lot of [H5N1] virus in California’s cows and birds. California is the number one state for dairy cattle, and so far, 703 herds have tested positive for H5N1. That’s more than 2/3 of all the dairy farms in the state. Plus, 93 commercial or backyard poultry flocks, accounting for about 22 million animals, have also been infected.
    • Unfortunately, we don’t have the wastewater testing capabilities yet to differentiate between humans and animals. A recent preprint showed wastewater is picking up viruses from animals (rather than humans) through milk dumping, animal sewage, and bird contamination. We are also relying on epidemiologists’ accounts on the ground to sort through the signals.
  • Per an NIH news release,
    • “New findings from the National Institutes of Health’s (NIH) Researching COVID to Enhance Recovery (RECOVER) Initiative suggest that infection with SARS-CoV-2, the virus that causes COVID-19, may be associated with an increase in the number of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) cases. According to the results, 4.5% post-COVID-19 participants met ME/CFS diagnostic criteria, compared to 0.6% participants that had not been infected by SARS-CoV-2 virus.  RECOVER is NIH’s national program to understand, diagnose, prevent, and treat Long COVID.
    • “The research team, led by Suzanne D. Vernon, Ph.D., from the Bateman Horne Center in Salt Lake City, examined adults participating in the RECOVER adult cohort study to see how many met the IOM clinical diagnostic criteria for ME/CFS at least six months after their infection. Included in the analysis were 11,785 participants who had been infected by SARS-CoV-2 and 1,439 participants who had not been infected by the virus. Findings appear in the Journal of General Internal Medicine.
    • “ME/CFS is a complex, serious, and chronic condition that often occurs following an infection. ME/CFS is characterized by new-onset fatigue that has persisted for at least six months and is accompanied by a reduction in pre-illness activities; post-exertional malaise, which is a worsening of symptoms following physical or mental activity; and unrefreshing sleep plus either cognitive impairment or orthostatic intolerance, which is dizziness when standing. People with Long COVID also experience some or all of these symptoms.
    • “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least three months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems. People with Long COVID report a variety of symptoms including fatigue, pain, and cognitive difficulties.
    • “Dr. Vernon and her team determined that new incidence cases of ME/CFS were 15 times higher than pre-pandemic levels.
    • “These findings provide additional evidence that infections, including those caused by SARS-CoV-2, can lead to ME/CFS.”
  • The American Hospital Association News tells us,
    • The San Francisco Department of Public Health Jan. 10 announced a presumptive positive case of H5N1 bird flu in a child after they experienced symptoms of fever and conjunctivitis. The child was not hospitalized and has since fully recovered, the agency said. An initial investigation by SFDPH did not reveal how the child may have contracted the virus, and the department is continuing to investigate.
  • Per Medscape,
    • More than 15 million people, accounting for 4.6% of the US population, were diagnosed with at least one autoimmune disease from January 2011 to June 2022; 34% were diagnosed with more than one autoimmune disease.
    • Sex-stratified analysis revealed that 63% of patients diagnosed with autoimmune disease were women, and only 37% were men, establishing a female-to-male ratio of 1.7:1; age-stratified analysis revealed increasing prevalence of autoimmune conditions with age, peaking in individuals aged ≥ 65 years.
    • Among individuals with autoimmune diseases, 65% of patients had one condition, whereas 24% had two, 8% had three, and 2% had four or more autoimmune diseases (does not add to 100% due to rounding).
    • Rheumatoid arthritis emerged as the most prevalent autoimmune disease, followed by psoriasis, type 1 diabetes, Grave’s disease, and autoimmune thyroiditis; 19 of the top 20 most prevalent autoimmune diseases occurred more frequently in women.
    • Source: https://www.jci.org/articles/view/178722
  • The American Medical Associations shares what doctors wish their patients knew about Parkinson’s Disease.
  • The New York Times reports,
    • “The number of people in the United States who develop dementia each year will double over the next 35 years to about one million annually by 2060, a new study estimates, and the number of new cases per year among Black Americans will triple.
    • “The increase will primarily be due to the growing aging population, as many Americans are living longer than previous generations. By 2060, some of the youngest baby boomers will be in their 90s and many millennials will be in their 70s. Older age is the biggest risk factor for dementia. The study found that the vast majority of dementia risk occurred after age 75, increasing further as people reached age 95.
    • “The study, published Monday in Nature Medicine, found that adults over 55 had a 42 percent lifetime risk of developing dementia. That is considerably higher than previous lifetime risk estimates, a result the authors attributed to updated information about Americans’ health and longevity and the fact that their study population was more diverse than that of previous studies, which have had primarily white participants.
    • “Some experts said the new lifetime risk estimate and projected increase in yearly cases could be overly high, but they agreed that dementia cases would soar in the coming decades.”
  • Health Day considers whether “Doctors Can Estimate Life Expectancy After a Dementia Diagnosis?”
    • “Updated estimates give a better picture of how long a person will live following a dementia diagnosis.
    • “Age plays a factor in how long people have left.
    • “Women tend to have longer life expectancy than men.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “Johnson & Johnson on Monday said it has agreed to acquire Intra-Cellular Therapies, a developer of drugs for diseases of the brain, for $132 per share, or about $14.6 billion.
    • “The announcement of the deal, which if completed would be the largest acquisition of a biotechnology company since early 2023, came on the first day of the J.P. Morgan Healthcare Conference, an industry meeting that’s known for dealmaking.
    • “The chief prize in buying Intra-Cellular is a medicine known as Caplyta that’s approved in the U.S. to treat schizophrenia and bipolar depression. The biotech recently asked the Food and Drug Administration to expand Caplyta’s clearance to include major depressive disorder, which affects about 10 times as many people as have schizophrenia and a little more than three times as many as have bipolar depression.”
  • and
    • “Eli Lilly has turned to a biotechnology startup for help building its pipeline of cancer drugs, agreeing on Monday to purchase an experimental cancer drug from privately held Scorpion Therapeutics for as much as $2.5 billion.
    • “As part of the deal, Scorpion will spin out a new, independent company that will hold its other assets as well as inherit its employees. Lilly will take a minority stake in the new company, which will be owned by Scorpion’s current shareholders, among them Atlas Venture, Vida Ventures and Omega Funds.
    • “Current Scorpion CEO Adam Friedman will lead the new company along with other members of the startup’s management.”
  • and
    • “Late last week, Biogen made an unsolicited offer to buy one of its partners, brain drug developer Sage Therapeutics.
    • “The two biotechnology companies have worked together over the past four years on a mood-stabilizing medicine known as Zurzuvae. They split research costs and, after the medicine got approved as a treatment for postpartum depression, began sharing profits.
    • B”ut Biogen now wants Zurzuvae all to itself. In a Jan. 10 letter to Sage’s top executive Barry Greene, Biogen CEO Christopher Viehbacher wrote that his company’s experience selling nervous system drugs would “enable more streamlined operations and efficient commercial execution” around Zurzuvae, which, in turn, should improve patient access.” 

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