Thursday Report

Government Contracting

Thursday Report

David Ermer–ACA, CDC, FDA, Generative AI, Government Contracting, HSA, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Mark Tegethoff on Unsplash

Happy first day of Spring!

From Washington, DC,

  • Per Becker’s Health IT,
    • The American Hospital Association and Health-ISAC are alerting hospitals to a social media post alleging plans for a coordinated, multi-city terrorist attack on healthcare facilities in the coming weeks.
    • The organizations said they are sharing the information as a precaution and remain in close contact with the FBI. They plan to provide updates as more details emerge, according to a March 20 news release.
    • The AHA and Health-ISAC said there is no information available to corroborate or discount the threat’s credibility.
    • “Generally, foreign terrorist groups do not publicize their upcoming attacks. However, this widely viewed post may encourage others to engage in malicious activity directed toward the health sector, so threats of this nature should be taken seriously,” the news release reads. “Security teams should review emergency management plans and spread awareness of the potential threat internally.”
  • Health Affairs Forefront offers reflections on the 15th anniversary of the Affordable Care Act, which will be marker on March 23, and an idea about how to add high deductible plans with health savings accounts to marketplace plans, which in the FEHBlog’s view is a great idea.
  • The American Hospital Association News tells us,
    • The Equal Employment Opportunity Commission and the Department of Justice yesterday announced the release of two documents warning against unlawful discrimination related to diversity, equity and inclusion in the workplace. A one-pager, “What To Do If You Experience Discrimination Related to DEI at Work,” and a Q&A, “What You Should Know About DEI-Related Discrimination at Work,” are based on Title VII, existing EEOC policy and Supreme Court precedent. 
    • “DEI is a broad term that is not defined in Title VII of the Civil Rights Act of 1964,” the agencies said. “In the past five years, DEI policies, programs, and practices have become increasingly prevalent in many of our nation’s largest and most prominent businesses, universities, and cultural institutions. The widespread adoption of DEI, however, does not change longstanding legal prohibitions against the use of race, sex, and other protected characteristics in employment.”
  • and
    • The Food and Drug Administration today issued an alert on a potentially high-risk issue with Calyxo CVAC Aspiration Systems. In patients who have thick fluid in their kidneys at the start of the procedure, the system can cause reduced fluid overflow, potentially leading to excessive pressure in the kidneys. Serious death or injury could occur if the increased pressure is not addressed. Calyxo has reported one death associated with the issue.
  • Per an HHS news release,
    • “Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potential health risks of contaminants in human foods. Chemical contaminants include a broad range of chemical substances that may be present in food and that have the potential to cause harm.”
  • The President today signed an executive order implementing the following policy,
    • “The Federal Government spends approximately $490 billion per year on Federal contracts for common goods and services — the types of goods and services purchased by nearly every executive department and agency (agencies) — making it the largest buyer of goods and services in the world.  As a matter of sound management, these standardized procurement functions should be carried out in the most efficient and effective manner possible for the American taxpayer. The General Services Administration was established in 1949 through the Federal Property and Administrative Services Act, 40 U.S.C. 101 et seq., to provide “an economical and efficient system” for the core procurement services for agencies (40 U.S.C. 101).  It is time to return the General Services Administration to its original purpose, rather than continuing to have multiple agencies and agency subcomponents separately carry out these same functions in an uncoordinated and less economical fashion.”
  • Federal News Network discusses the EO here.
  • Bloomberg Law reports,
    • “The US Agriculture Department is preparing to spend as much as $100 million to combat bird flu by soliciting proposals for new poultry vaccines and virus detection methods.
    • “Officials plan to announce the funding opportunity for companies including vaccine manufacturers on Thursday, according to a USDA email obtained by Bloomberg Government and verified by two congressional staff granted anonymity to discuss the not-yet-public plan. 
    • “The solicitation announcement is expected to seek proposals that prevent, treat, or research bird flu infections, according to the Wednesday email signed by Tucker Stewart, the deputy assistant secretary for USDA’s Office of Congressional Relations.
    • “The money would be the agency’s latest step toward rolling out a $1 billion bird flu response plan that Agriculture Secretary Brooke Rollins announced in February. Rollins has downplayed the role vaccines will play in fighting the virus since announcing the strategy, citing high costs and low effectiveness rates.” 

From the public health and medical research front,

  • NBC News informs us,
    • “Prescriptions for ADHD medications have been spiking in recent years, with the sharpest increase among middle-aged and older women. They’re also the least likely to misuse the prescription stimulants, a new study found.
    • “The rise among women ages 35 to 64 has been substantial. At the end of 2022, 1.7 million women in this age group were prescribed stimulants such as Adderall and Ritalin for ADHD, compared to 1.2 million prescriptions in 2019.
    • “There’s been an overall jump in ADHD prescriptions since the pandemic and the rise of telehealth. The new analysis, published in JAMA Psychiatry by researchers at the National Institute on Drug Abuse, also looked into how the medications are being misused — that is, taking more of the drugs than prescribed, taking them at times that differed from what the doctor ordered or using medication from someone else’s prescription.” 
  • Cardiovascular Business points out,
    • “Using cannabis significantly raises a person’s myocardial infarction risk, even if they are young and otherwise quite healthy, according to the research team behind two new studies. The first is a retrospective analysis that was just published in JACC Advances, while the other is a meta-analysis being presented at ACC.25, the American College of Cardiology’s annual conference. 
    • “Asking about cannabis use should be part of clinicians’ workup to understand patients’ overall cardiovascular risk, similar to asking about smoking cigarettes,” Ibrahim Kamel, MD, clinical instructor at the Boston University Chobanian & Avedisian School of Medicine and the lead author of both studies, said in a statement. “At a policy level, a fair warning should be made so that the people who are consuming cannabis know that there are risks.”
    • “Kamel et al. performed a retrospective study of more than 4.6 million adults 50 years old or younger. All participants were free of significant cardiovascular comorbidities with no prior coronary artery disease. The average follow-up period was more than three years. Overall, the group found that cannabis use significantly increased a person’s risk of a myocardial infarction, ischemic stroke, heart failure and cardiovascular death.”
  • Per Healio,
    • “Markers of subclinical heart damage were observed among individuals who smoke cigarettes, even decades after quitting, according to a study published in the Journal of the American College of Cardiology.
    • “New data from the Cross-Cohort Collaboration-Tobacco Work Group showed that cigarette smoking was associated with elevated markers of inflammation, thrombosis and atherosclerosis, all of which decreased after cessation, except for coronary calcium, which remained elevated 30 years later.
    • “Understanding the mechanisms of smoking-related injury and the most sensitive biomarkers of subclinical harm is critical to clinical trial planning and tobacco regulatory policy, and might be important for planning studies and informing regulatory of new and emerging tobacco products as well,” Michael J. Blaha, MD, MPH, professor of medicine and director of clinical research at the Ciccarone Center for the Prevention of Cardiovascular Disease at Johns Hopkins Medicine, told Healio. “The degree to which new and emerging tobacco products affect these same biomarkers will need to be explored.”
  • On the bright side, the Wall Street Journal illustrates how “Drug Overdoses Are on the Decline, in Charts. Fatalities from drugs including fentanyl are down from recent peaks.”
  • The AP reports,
    • “Nestle USA is recalling certain batches of its Lean Cuisine and Stouffer’s frozen meals for possible contamination with “wood-like material” after a report of potential choking. 
    • “The recall applies to limited quantities of meals with best-before dates between September 2025 and April 2026. They include Lean Cuisine Butternut Squash Ravioli, Lean Cuisine Spinach Artichoke Ravioli, Lean Cuisine Lemon Garlic Shrimp Stir Fry and Stouffer’s Party Size Chicken Lasagna. The products were distributed to major stores in the U.S. between September 2024 and this month. No products beyond those listed are affected. 
    • “Nestle officials said they are working with the U.S. Food and Drug Administration and the Agriculture Department and investigating the source of the wood-like material. The company said it launched the recall after consumers reported the problem, including at least one potential choking incident.”
  • Per Healio,
    • “Adults with insulin-treated type 2 diabetes had greater HbA1c reductions and larger improvement in time in range with use of an automated insulin delivery system compared with standard care, according to findings from a new trial.”
  • Per BioPharma Dive,
    • “On Wednesday, Novartis gave a more detailed look at long-awaited clinical data that the company believes will help secure a broad approval for a successor drug to its blockbuster gene therapy Zolgensma.
    • “The drug, code-named OAV101, shares the same active ingredient as Zolgensma, which in 2019 gained U.S. approval for the treatment of a rare, muscle-wasting illness known as spinal muscular atrophy. Zolgensma, though, is injected into the veins, and is only cleared for use in patients under two years of age. Novartis has spent years trying to show OAV101, which is shot right into the spine, can be a safe and effective therapy for older kids.”

From the artificial intelligence front,

  • STAT News reports,
    • A panel of experts at a leading specialty society announced in a new clinical guideline that they have decided not to decide whether to recommend AI-assisted colonoscopies.
    • “After reviewing studies and using existing information to model outcomes, experts enlisted by the American Gastroenterological Association determined that using AI definitely increases adenoma detection rate (ADR), or colonoscopies that find polyps. But they figure, with low certainty, that using AI in screening only leads to 2 fewer colorectal cancer-related deaths per 10,000 people over 10 years. Citing a close call and fuzzy evidence, the panel decided not to issue a recommendation.”
  • MedTech Dive explains, “Quest, Google team on gen AI; GE Healthcare plans autonomous imaging; GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.” For details read the article.
  • RAND concludes “AI Models Are Skilled at Identifying Appropriate Responses to Suicidal Ideation, but Professionals Still Needed.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “GE HealthCare launched its Invenia Automated Breast Ultrasound Premium system Thursday that features artificial intelligence tools.
    • “The system, which has premarket approval from the Food and Drug Administration, is designed to help better detect breast cancer in women with dense breasts.
    • “Detecting breast cancer in this patient population with mammography can be difficult for radiologists because both dense tissue and cancerous masses appear white in images, according to the American Cancer Society.
    • “Automated breast ultrasound produces clearer and more detailed images and has been shown in multiple studies to improve the sensitivity of detecting invasive cancer in dense breasts when used alongside mammography.”
  • and
    • “Post-acute care technology companies Medalogix and Forcura announced their merger Wednesday.
    • “The companies aim to create a platform for streamlining patient care transitions and better connect post-acute care providers to the broader healthcare system. Berkshire Partners, a Boston-based private equity firm, will be the majority owner of the combined company, which is not yet named, according to a news release. Chicago-based private equity firm The Vistria Group will be the largest minority shareholder, the release said.
    • “Financial terms of the deal were not disclosed.”
  • Per Fierce Pharma,
    • “Optum Rx is shifting its payment models to better meet the needs of pharmacies and consumers, the pharmacy benefit manager announced Thursday.
    • “The company said it will shift to a cost-based model, which will better align with “the costs pharmacies may face due to manufacturer pricing actions.” The PBM expects the change to be a positive one for the more than 24,000 independent and community pharmacies it works with, along with its members.
    • “Optum said it will begin to roll out the updated models now and intends to have a full implementation in place by January 2028.”
  • MedCity News lets us know,
    • “Evvy, a women’s health company, is now offering fertility insights through its vaginal microbiome test, the company announced on Tuesday.
    • “New York City-based Evvy is a direct-to-consumer company. Its vaginal microbiome test, starting at $129, checks for bacteria and fungi (or microbes) in people’s vaginas. After taking the test, people receive a report that explains the microbes found in the vagina and the health conditions related to those microbes. Based on the results, consumers receive a customized treatment plan and a one-on-one virtual session with a coach.
    • “Now, the test results include a section on fertility insights. Users of the test receive a “protective score,” which is a measure of protective bacteria like Lactobacillus. This is associated with improved fertility, lower inflammation and better pregnancy outcomes.”
  • Per BioPharma Dive,
    • “Sanofi agreed to pay $600 million for a therapy in early human testing that may have the ability to “reset” a patient’s immune system and ward off debilitating inflammatory diseases.
    • “The treatment, dubbed DR-0201, is known as a bispecific myeloid cell engager. It’s designed to engage specific immune cells that can prompt the body to deplete disease-causing B cells. It’s shown promise in preclinical and Phase 1 studies, Sanofi said. 
    • “As part of the deal announced Thursday, Sanofi agreed to pay as much as $1.3 billion more to privately held Dren Bio if DR-0201 succeeds in reaching certain development and launch goals. The French drugmaker expects to take over the DR-0201 program in the second quarter.”

Happy Pi Day!

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Obesity, U.S. Healthcare–

From Washington, DC

  • The American Hospital Association (AHA) News lets us know,
    • “The Senate March 14 approved by a vote of 54-46, a continuing resolution to fund the government through Sept. 30. The House passed, by a vote of 217-213, the bill earlier in the week. President Trump is expected to sign the measure.
    • “The bill extends certain key health care provisions that were set to expire at the end of March, including eliminating Medicaid disproportionate share hospital cuts, and extending the enhanced low-volume adjustment and Medicare-dependent hospital programs; key telehealth waivers; the hospital-at-home program; the Work Geographic Index Floor program; and add-on payments for ambulance services.”
  • Upshot — No government shutdown.
  • Fierce Healthcare adds,
    • “A last-ditch effort to pass a bipartisan healthcare package pushed aside at the end of 2024 that includes telehealth extensions and pharmacy benefit manager reform, reverses doc pay cuts and addresses the opioid crisis has failed.
    • “That legislation was brought to the floor by Senators Ron Wyden, D-Oregon and Bernie Sanders, I-Vermont, March 14 ahead of a key procedural vote [on the continuing resolution]. The senators’ bill required unanimous consent, or it would not advance. Sen. Rick Scott, R-Florida, quickly rejected the bill.”
  • Per a Senate news release,
    • “Today, the Senate overwhelmingly voted to pass the Halt All Lethal Trafficking of (HALT) Fentanyl Act. The bipartisan legislation, led by Judiciary Chairman Chuck Grassley (R-Iowa), Health, Education, Labor and Pensions Chairman Bill Cassidy, M.D. (R-La.) and Sen. Martin Heinrich (D-N.M.), would permanently classify fentanyl-related substances before their temporary Schedule I status expires on March 31, 2025. 
    • “Last month, the HALT Fentanyl Act was passed out of the Senate Judiciary Committee by a bipartisan vote of 16-5. Attorney General Pam Bondi has endorsed the legislation. President Trump’s Office of Management and Budget has confirmed that, if Congress passes the bill in its current form, the president will sign it. The legislation now heads to the House of Representatives.
    • “The HALT Fentanyl Act is a critical step towards ending the crisis that’s killing hundreds of thousands of precious American lives. I thank my Senate colleagues for passing this bill with broad, overwhelming support. I urge my House colleagues to swiftly pass the Senate version of this battle-tested, bipartisan bill to save lives, advance research and support our brave men and women in blue,” Grassley said.: * * *
    • “Download bill text HERE and a fact sheet HERE.”
  • The AHA News tells us,
    • “The Senate Finance Committee March 14 held a confirmation hearing on Mehmet Oz’s nomination for administrator of the Centers for Medicare & Medicaid Services. Oz, a doctor and former television show host, indicated that some of his priorities in the position, if confirmed, would be to reduce health care spending by improving poor health, increasing use of technology, incentivizing providers, and stopping wasteful spending, fraud and abuse. The committee will soon schedule a vote on whether to advance his nomination to the full Senate.”
  • The Wall Street Journal adds,
    • “Mehmet Oz, the Trump administration’s nominee to lead the Medicare agency, said some actions by private insurers in the Medicare Advantage program amounted to fraud and cheating, and he intended to go after them as head of the Centers for Medicare and Medicaid Services. 
    • “His comments, during his Senate confirmation hearing on Friday, were focused on industry practices that can boost insurers’ Medicare Advantage payments by documenting more diagnoses in their patients. Medicare Advantage insurers get higher payouts when patients have certain conditions. 
    • “There’s a new sheriff in town,” said Oz, a heart surgeon known for his long-running television show. He criticized “upcoding” in Medicare Advantage and said, “I pledge if confirmed I will go after it.”
  • Per Senate news releases,
    • “Sen. Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, laid out his health care priorities during a hearing to consider Dr. Mehmet Oz’s nomination to be Administrator of the Centers for Medicare and Medicaid Services (CMS). Oz committed to supporting Grassley’s efforts to lower prescription drug costs, strengthen rural health care, help kids with exceptional medical needs, preserve transitional health plans and improve the agency’s responsiveness to Congress.”
  • and
    • “At a U.S. Senate Finance Committee hearing to consider the nomination of Dr. Mehmet Oz to be Centers for Medicare and Medicaid Services (CMS) Administrator, Chairman Mike Crapo (R-Idaho) highlighted Dr. Oz’s wealth of firsthand experience as an accomplished physician and his clear vision for creating a healthier nation.  Crapo and Dr. Oz discussed how he would address the nation’s chronic disease epidemic, as well as how he might approach reforming payment programs to improve efficiency.
    • “Crapo concluded the hearing with, “There is no doubt you are qualified to serve as the next Administrator of [CMS], and I look forward to voting in favor of your nomination and am urging all of my colleagues to do the same.”
  • The AHA News informs us,
    • “The Medicare Payment Advisory Commission March 13 released its March report to Congress that includes recommendations for hospital and other Medicare payment systems for fiscal year 2026. Among the recommendations, MedPAC urged Congress to update the base payment rate for hospitals by current law plus 1%.  
    • “An update above current law is necessary given the combination of providers’ continued financial pressures, and almost two decades of sustained and substantial negative Medicare margins,” AHA wrote in a January letter to MedPAC. “Simply put, even after the recommended payment update, Medicare’s payments to hospitals would remain inadequate.” 
  • Per a Food and Drug Administration news release,
    • “Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth. The campaign, which launched in 2018 under the leadership of President Trump, was found to have prevented an estimated 444,252 American youth (age 11 to 17 at study recruitment) from starting to use e-cigarettes between 2023 and 2024.
    • “The new study, published in the peer-reviewed scientific journal American Journal of Preventive Medicine, found evidence that the campaign contributed to the nearly 70% decline in e-cigarette use among American youth that has occurred since 2019. According to the National Youth Tobacco Survey, the number of U.S. middle and high school students who currently use e-cigarettes has declined from 5.38 million in 2019 to 1.63 million in 2024, the lowest level in a decade.”

From the judicial front,

  • Politico reports,
    • “A federal appeals court has given President Donald Trump’s administration the go-ahead to enforce a pair of controversial executive orders that seek to root out diversity, equity and inclusion efforts in federal agencies and government contractors.
    • “The three-member appeals panel — including two judges appointed by Democratic presidents — lifted a lower court’s injunction that had put the policy on hold last month.
    • The ruling Friday from the panel of the Richmond, Virginia-based 4th Circuit Court of Appeals is not a final decision on the legality of Trump’s anti-DEI policy. It merely allows the government to administer the policy while litigation continues.
    • “In separate opinions explaining their votes, the three judges suggested the Trump administration should be allowed to demonstrate that it will abide by anti-discrimination laws and respect First Amendment rights as it implements the executive orders, which Trump issued on the first two days of his new term.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. COVID-19 activity is declining nationally but elevated in some areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is declining nationally but elevated in some areas of the country. Wastewater levels and emergency department visits are at low levels, and laboratory percent positivity is stable. 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
      • “Seasonal influenza activity remains elevated nationally but has decreased for four consecutive weeks. Data to date suggest the season has peaked, however, flu-related medical visits, hospitalizations, and deaths remain elevated, and CDC expects several more weeks of flu activity.
      • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity is declining in most areas of the country. 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 is low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota’s CIDRAP reports,
    • “The measles outbreak in Texas has risen by 36 cases, pushing the US case count for the year past the number for all of 2024.
    • “The outbreak of the highly contagious virus, which began in late January and is centered in the western part of the state, now stands at 259 cases, according to the latest update from the Texas Department of State Health Services (DSHS). Of those patients, 257 are either unvaccinated or have unknown vaccination status, and 201 are children ages 17 or younger. Thirty-four patients have been hospitalized, with one death in an unvaccinated child who had no known underlying conditions.
    • “Eleven counties to date have reported cases, but two thirds of the cases (174; 67%) are in Gaines County, which has one of the highest rates of school-aged children in Texas who have opted out of at least one vaccine. The county is home to a large Mennonite community with low vaccination rates.
    • “DSHS officials said they have determined that three of the case-patients previously listed as vaccinated were not vaccinated. Two had received their measles, mumps, and rubella (MMR) vaccine doses 1 to 2 days before their symptoms started and after they had been exposed to the virus. The third had a vaccine reaction that mimicked a measles infection and has been removed from the case count.”
  • The University of Minnesota CIDRAP also notes,
    • “The US Food and Drug Administration (FDA) yesterday announced the strains it recommends manufacturers include in seasonal flu vaccines for the 2025-26 flu season, and [as usual] they mirror recommendations announced by the World Health Organization (WHO) last month.” 
  • Gallup reports,
    • “Americans’ assessments of their mental and physical health are the least positive they have been in Gallup’s 24-year trend, reflecting a decadelong decline that began around 2013 and accelerated sharply with the onset of the COVID-19 pandemic in 2020.
    • “Three in four U.S. adults in Gallup’s latest annual reading rate their mental health (75%) and, separately, their physical health (76%) as either “excellent” or “good.” This contrasts with a record-high 89% rating their mental health positively as recently as 2012, and a high of 82% for physical health in 2003.
    • “As fewer Americans have rated their mental and physical health positively, most of the change has been in the percentages rating each aspect “excellent” — shrinking to 31% for mental health and 24% for physical health.”
  • The National Science Foundation points out,
    • “A team of researchers led by the recipient of a U.S. National Science Foundation Faculty Early Career Development grant has developed a new storage method for protein-based drugs that could potentially eliminate the need for refrigeration of important medicines. Using an oil-based solution and a molecule acting as a coating to enclose the proteins in these drugs, researchers demonstrated a technique to prevent the proteins from degrading rapidly — a protection that traditionally requires refrigeration.
    • “The research is led by Scott Medina at Pennsylvania State University and published in Nature Communications. It demonstrates a possible practical application to eliminate the need to refrigerate hundreds of life-saving medicines like insulin, monoclonal antibodies and viral vaccines.
    • “The work could eventually reduce the cost of refrigerating such drugs throughout the supply chain and enable greater use of protein-based therapies where constant refrigeration isn’t possible, including military environments. 
    • “Over 80% of biologic drugs and 90% of vaccines require temperature-controlled conditions. This approach could revolutionize their storage and distribution, making them more accessible and affordable for everyone,” says Medina.”
  • Per a National Institutes of Health news release,
    • “Researchers at the National Institutes of Health (NIH) have determined that dermatitis resulting from topical steroid withdrawal (TSW) is distinct from eczema and is caused by an excess of an essential chemical compound in the body. Scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) identified treatments that could be studied in clinical trials for the condition based on their potential to lower levels of the chemical compound—called nicotinamide adenine dinucleotide (NAD+), a form of vitamin B3. The findings were published today in the Journal of Investigative Dermatology.
    • “Dermatitis is characterized by inflammation, itching, or burning sensations on the skin, and can result from various conditions including TSW and eczema. Eczema, also known as atopic dermatitis, is a common cause of dermatitis and affects 10 to 30% of children and 2 to 10% of adults each year in the United States. Topical steroids—specifically glucocorticoids or topical corticosteroids—have long been used as a first-line treatment for dermatitis caused by eczema because the drugs are safe, effective, easy to apply, and considered well-tolerated.” * * *
    • “The scientists provisionally established criteria that can be used by health care providers to identify TSW in people. People who have stopped topical steroid treatment and meet the criteria may be diagnosed by practitioners as having TSW. The researchers suggest that patients identified as having TSW could be treated using the proposed mitochondrial complex I-blocking drugs.
    • “The results of this study may help practitioners identify TSW in patients and work towards developing safe and effective treatments. According to the researchers, more research is needed to determine whether all patients with TSW have an excess of NAD+, or if there are other features that define TSW. Additionally, the diagnostic criteria will help health care providers and researchers to better understand the prevalence of TSW and evaluate the effects of using topical steroids.”

From the U.S. healthcare business front,

  • The New York Times reports,
    • “It’s easy to make a medical case for blockbuster weight loss drugs like Wegovy and Zepbound, which have been shown to prevent heart attacks and strokes and save lives.
    • “But for the employers and government programs being asked to pay for the medications, the financial case for them is less clear. Are the drugs’ benefits worth their enormous cost?
    • “The answer right now is no, according to a new study published on Friday in the journal JAMA Health Forum, by researchers at the University of Chicago.
    • “To be considered cost effective by a common measure used by health economists, the price of Novo Nordisk’s Wegovy would need to be cut by over 80 percent, to $127 per month, the researchers concluded. And Eli Lilly’s Zepbound would be cost effective only if its price fell by nearly a third, to $361 per month. (Zepbound warranted a higher price, the researchers said, because it produced greater benefits in clinical trials.)”
  • Per STAT News,
    • “Biotech company Altimmune announced in an investor call yesterday that it will study its obesity drug, which targets receptors of the GLP-1 and glucagon hormones, in alcohol use disorder, as mounting evidence supports the potential of GLP-1 drugs to help with addiction.
    • “Altimmune executives think that their molecule, called pemvidutide, could be particularly helpful for liver conditions, since there are glucagon receptors located in the liver. The company has already been studying the drug in weight loss and in the liver disease MASH, and are now expanding into alcohol-related conditions.
    • “The company plans to start a study in alcohol use disorder in the second quarter of this year, and another study in alcohol-related liver disease in the third quarter.
    • “Eli Lilly has also started studying mazdutide, a GLP-1/glucagon drug it’s developing with Chinese biotech Innovent, in alcohol use disorder. Lilly CEO Dave Ricks has said the company also plans to test obesity drugs in other areas of addiction, like nicotine and drug use disorders.
    • “Novo Nordisk is running a study of its obesity drugs in alcohol-related liver disease but has not yet started any trials in addiction.”
  • Per Beckers Hospital CFO Report,
    • As healthcare organizations continue to navigate shifting financial and operational landscapes, new data from Kaufman Hall and Strata highlights significant trends in physician productivity, compensation, and costs.
    • In the fourth quarter, median work relative value units per full-time physician varied across specialties, with medical specialties leading at 7,139 wRVUs. Physician compensation followed a similar pattern, with surgical specialists earning the highest median paid compensation at $491,000 per FTE.
    • Despite an encouraging increase in net revenue per physician, rising expenses remain a challenge. These figures underscore the mounting financial pressures and workforce challenges facing healthcare organizations. For executives, balancing rising costs, evolving productivity demands, and compensation structures will be critical in sustaining financial stability and operational efficiency.
  • Beckers Hospital Review points out ten drugs poised to be top sellers next year.

Thursday Report

David Ermer–Congress, Federal employment benefits, Government Contracting, Medical / Rx research, Mental health care, OPM, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Per a Senate press release,
    • “U.S. Senate Democratic Whip Dick Durbin (D-IL) today delivered a speech on the Senate floor highlighting his Drug-price Transparency for Consumers (DTC) Act, a bill he is introducing with Senator Chuck Grassley (R-IA) that would require price disclosures on advertisements for prescription drugs in order to empower patients and reduce Americans’ colossal spending on medications. The Government Accountability Office (GAO) has found that prescription drugs advertised directly to consumers accounted for 58 percent of Medicare’s spending on drugs between 2016 and 2018, while a 2023 study in the Journal of the American Medical Association found that two-thirds of advertised drugs offered “low therapeutic value.” By requiring direct-to-consumer (DTC) advertisements for prescription drugs to include a disclosure of the list price, patients can make informed choices when inundated with drug commercials and pharmaceutical companies may reconsider their pricing and advertising tactics.  In recent years, the pharmaceutical industry has sued to keep the prices of their drugs out of their TV advertisements.”
  • Politico reports,
    • Republican funding leaders have made an opening offer to Democrats as the two parties launch negotiations toward a deal to fund the government before the mid-March shutdown deadline.
    • Congress’ top appropriators gathered privately Thursday evening in the Capitol for an hour-long “four corners” meeting — the first concrete step toward a bipartisan funding agreement as Republican leaders begin to embrace the idea of a cross-party accord that funds the government and raises the debt limit, while also potentially boosting disaster aid and border security funding. The beginning of negotiations follows months of inaction on a bipartisan government funding plan, after lawmakers first punted beyond the October start of the fiscal year and then again resorted to a stopgap measure in December, pushing the spending cliff into the first months of the new Trump administration.
  • Federal News Network tells us,
    • “Agencies have until the end of the day Friday to revise their telework policies and begin ordering federal employees to work onsite full-time, according to a return-to-office memo from the Office of Personnel Management Wednesday evening.
    • “OPM is recommending agencies target a 30-day deadline to be in full compliance with the return-to-office directive President Donald Trump signed on his first day in office. Trump’s executive order told agencies to return their federal employees to work at the office “as soon as practicable.” The order also called for agencies to end “remote work arrangements” and require employees to work in person full-time, while leaving room for some exemptions.”
  • FedSmith lets federal and postal employees know the best dates to retire in 2025.
  • Per an OFCCP news release,
    • On January 21, 2025, the White House and President Donald Trump issued an Executive Order: “Ending Illegal Discrimination and Restoring Merit-Based Opportunity”, which revoked Executive Order 11246. For 90 days from the date of this order, Federal contractors may continue to comply with the regulatory scheme in effect on January 20, 2025.  
    • The Office of Federal Contract Compliance Programs shall immediately cease:
      • Promoting “diversity”.
      • Holding Federal contractors and subcontractors responsible for taking “affirmative action”; and
      • Allowing or encouraging Federal contractors and subcontractors to engage in workforce balancing based on race, color, sex, sexual preference, religion, or national origin.
    • It is important to note that requirements under Section 503 of the Rehabilitation Act, 29 U.S.C. 793, and the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA), 38 U.S.C. 4212, both enforced by OFCCP, are statutory and remain in effect.

From the judicial front,

  • MedPage Today informs us,
    • “Members of the family who own Purdue Pharma, the maker of oxycodone hydrochloride (OxyContin), and the company itself, agreed to pay up to $7.4 billion in a new settlement to lawsuits over the toll of the powerful prescription painkiller, New York Attorney General Letitia James announced Thursday.
    • “The deal, agreed to by Purdue Pharma, the Sackler family members who own the company, and lawyers representing state and local governments and thousands of victims of the opioid crisis, represents an increase of more than $1 billion over a previous settlement deal that was rejected last year by the U.S. Supreme Court.
    • “The Sacklers agreed to pay up to $6.5 billion, Purdue to pay $900 million, for a total of $7.4 billion.
    • “It’s among the largest settlements reached over the past several years in a series of lawsuits by local, state, Native American tribal governments, and others seeking to hold companies responsible for a deadly epidemic. Aside from the Purdue deal, others worth around $50 billion have been announced — and most of the money is required to be used to stem the crisis.
    • “The deal still needs court approval, and some of the details are yet to be ironed out. An arm of the Department of Justice opposed the previous settlement, even after every state got on board, and took the battle to the U.S. Supreme Court. But under President Donald Trump, the federal government is not expected to oppose the new deal.”
  • The Washington Post reports,
    • The Supreme Court cleared the way Thursday for a major corporate transparency law that requires millions of businesses to make new ownership disclosures in an effort to combat financial crimes.
    • The high court lifted a block on the enforcement of the Corporate Transparency Act while a federal Circuit Court of Appeals based in New Orleans weighs the law’s constitutionality.
    • “The act, which passed in 2021, requires most U.S. businesses to disclose which of its owners control more than 25 percent of the stock or hold a similar stake in equity. The law aims to expose bad actors who create shell companies to disguise their identities while carrying out money laundering, tax fraud, drug trafficking or the financing of terrorism. It would affect more than 32 million businesses.”
  • Per Fierce Healthcare,
    • “An arbitrator has determined Prime Therapeutics violated federal and state antitrust laws against the AIDS Healthcare Foundation (AHF) and independent pharmacies.
    • “In a ruling (PDF) handed down Jan. 17, the AHF was awarded more than $10 million and injunctive relief after Prime Therapeutics was found to engage in horizontal price-fixing with Cigna’s pharmacy benefit manager (PBM), Express Scripts.
    • “Prime is a PBM owned by Blue Cross Blue Shield state plans. It has more than 20 million patients in its network affected by the collaboration.
    • “Prime was told to end its reimbursement structure for drugs under a long-standing collaboration with Express Scripts and to reimburse underpayments since June 30. The cozy relationship between Prime and Express Scripts allowed Prime to reimburse drugs and services the AHF provides to health plans, where Prime is the PBM, at a lower rate.”

From the public health and medical research front,

  • The New York Times reports,
    • “A study of more than 30,000 British adults diagnosed with attention deficit hyperactivity disorder, or A.D.H.D., found that, on average, they were dying earlier than their counterparts in the general population — around seven years earlier for men, and around nine for women.
    • “The study, which was published Thursday in The British Journal of Psychiatry, is believed to be the first to use all-cause mortality data to estimate life expectancy in people with A.D.H.D. Previous studies have pointed to an array of risks associated with the condition, among them poverty, mental health disorders, smoking and substance abuse.
    • “The authors cautioned that A.D.H.D. is substantially underdiagnosed and that the people in their study — most of them diagnosed as young adults — might be among the more severely affected. Still, they described their findings as “extremely concerning,” highlighting unmet needs that “require urgent attention.”
    • “It’s a big number, and it is worrying,” said Joshua Stott, a professor of aging and clinical psychology at University College London and an author of the study. “I see it as likely to be more about health inequality than anything else. But it’s quite a big health inequality.”
  • The American Hospital Association News notes,
    • “Perinatal mental health disorders affect countless mothers during pregnancy and postpartum, yet access to comprehensive care remains a challenge. Hospitals are stepping up to fill this gap, creating innovative programs that address the unique mental health needs of mothers during this critical period. A recent panel hosted by the AHA and the Policy Center for Maternal Mental Health highlighted the efforts of two trailblazing hospitals: Woman’s Hospital in Baton Rouge, La., and the University of Colorado Hospital Anschutz Medical Campus. READ MORE.” 
  • Per MedPage Today,
    • “Early Alzheimer’s pathology was not consistently linked to depressive symptoms in people without clinical dementia, cross-sectional data suggested.
    • “In people with normal cognition, depressive symptoms and amyloid pathology were not associated with each other (OR 1.13, 95% CI 0.90-1.40, P=0.29), reported Julie Oomens, PhD, of Maastricht University in the Netherlands, and co-authors.
    • “However, in people with mild cognitive impairment, the presence of depressive symptoms was tied to a lower likelihood of amyloid pathology (OR 0.73, 95% CI 0.61-0.89, P=0.001), Oomens and colleagues said in JAMA Psychiatry.
    • “The findings suggest that other mechanisms may underlie the previously seen associations between depressive symptoms and cognitive decline in late life, Oomens and colleagues observed.
    • “This large-scale study including data from 49 cohorts included in the Amyloid Biomarker Study shows that depressive symptoms were not consistently associated with a higher frequency of amyloid pathology in persons without dementia,” Oomens told MedPage Today. “This means that the earlier identified association between depressive symptoms and cognitive decline is likely not explained by Alzheimer’s disease pathology.”
  • and
    • Considering a risk score generated from multiple genetic variants linked to chronic obstructive pulmonary disease (COPD) caught undiagnosed cases of the disease better than conventional risk factors and respiratory symptoms alone, a study showed.
    • Adding the COPD polygenic risk score (PRS) to the Lung Function Questionnaire clinical risk score significantly improved the area under the curve by 0.03 to 0.06, suggesting a 3 to 6 percentage point increase in accuracy in identifying spirometry-defined, moderate to severe COPD, as researchers led by Matthew Moll, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, reported in JAMA.
  • and
    • “Intermittent explosive disorder (IED), characterized by impulsive aggression and poorly regulated emotional control, was associated with multiple classes of comorbidities, an analysis of 117.7 million healthcare records showed.
    • “Of 30,000 individuals with an IED diagnosis during their lifetime, 95.7% had at least one other psychiatric diagnosis, reported Yanli Zhang-James, MD, PhD, of SUNY Upstate Medical University in Syracuse, and co-authors in JAMA Psychiatry.
    • “All psychiatric subcategories and 92% of psychiatric diagnoses were significantly associated with IED, with hazard ratios (HRs) ranging from 2.1 for substance use disorder to 76.6 for disorders of adult personality and behavior.”
  • Per tctMD,
    • “Patients who have hypertension while lying down, even if their blood pressure is normal while sitting up, have greater CVD and mortality risks in the decades to come, according to an analysis of the Atherosclerosis Risk in Communities (ARIC) study.
    • “Through more than 25 years of follow-up, supine hypertension was associated with greater risks of fatal and nonfatal coronary heart disease, heart failure, stroke, and all-cause death, lead author Duc Giao, MD (Harvard Medical School, Boston, MA), and colleagues report in a study published online Wednesday in JAMA Cardiology.
    • “The results didn’t differ based on whether patients were taking antihypertensive medications or whether they also had seated hypertension. Although risks of adverse outcomes were greatest in patients with both seated and supine hypertension, those with high supine BP alone carried greater hazards compared with those with elevations only when seated.
    • “Our conclusion was that not only is supine blood pressure an important risk factor for cardiovascular disease, but also it’s possible we could be missing a high-risk state by simply focusing on the seated position,” senior author Stephen Juraschek, MD, PhD (Beth Israel Deaconess Medical Center and Harvard Medical School), told TCTMD. “There might be more information to be gathered when we lie people flat and measure their blood pressure in the lying position.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “UnitedHealth Group has named Tim Noel as the next CEO of UnitedHealthcare, replacing Brian Thompson, who was killed in New York City in December.
    • “Noel has been at the health care conglomerate since 2007 and most recently led UnitedHealthcare’s Medicare division — one of the company’s most important and profitable lines of health insurance. Its Medicare Advantage and Medigap supplemental plans made up almost half of UnitedHealthcare’s $300 billion of revenue last year.”
  • Per Healthcare Dive,
    • “Elevance’s profits took a serious hit in the fourth quarter of 2024, falling to $418 million — down more than half from $856 million in the prior-year period — amid higher medical costs in the safety-net Medicaid program, according to financial results released Thursday morning.
    • “Yet the insurer’s earnings were in line with analyst expectations after a hard year. Investors also found reason for optimism in revenue growth, with Elevance’s topline of $45 billion up about 6% year over year. Elevance’s stock, and shares in managed care peers, rose in Thursday morning trading following the results.
    • “Still, Elevance’s guidance for 2025 implies the insurer expects spending to remain elevated this year, and some market watchers are concerned about the health of Elevance’s growth outlook for privatized Medicare plans — another source of shrinking margins.”
  • On a related note, Kaufmann Hall discusses the “Next Phase of Inorganic Payer Growth.”
  • Modern Healthcare adds,
    • “The number of Chapter 11 bankruptcy filings in healthcare dropped significantly in 2024 from the previous year, though filings still hit historically high levels.
    • “Fifty-seven healthcare companies with more than $10 million in liabilities filed for bankruptcy protection in 2024, the second-highest level since 2019, according to a report released Thursday from Gibbins Advisors. But the 2024 total is still down from 79 filings in 2023.
    • “Pharmaceutical companies topped the list with 14 bankruptcy filings, followed by 11 senior care companies and 10 clinics and physician practices. Bankruptcy filings for clinics and physician practices hit the highest level in the past six years, according to the report.
    • “Five hospital groups filed for bankruptcy protection in 2024, compared with 12 groups in 2023. However, one of those groups, Steward Health Care, involved more than 30 hospitals and marked the largest bankruptcy in the hospital sector in decades, the report noted.”



Midweek Report

David Ermer–CMS, Congress, Government Contracting, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash
  • From a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) will hold a nomination hearing on Wednesday, January 29, at 10:00AM to consider Robert F. Kennedy Jr. to be Secretary of the U.S. Department of Health and Human Services.” 
  • In the meantime, Dorothy Fink is serving as acting HHS Secretary.
  • FedWeek shares “the key portions of the guidance from OPM on the federal hiring freeze issued by the new Trump administration that addresses issues including general and special exceptions, movement and promotions of current employees and a prohibition on using contractors to fill vacated positions.”
  • The President issued an executive order revoking the affirmative action requirements of E.O. 11246 which President Lyndon Johnson signed in 1965. This action relieves federal government contractors and subcontractors with a contract valued at $100,000 or more and 50 employees or more of the burden to develop and implement a detailed affirmative action program. These businesses remain subject to federal and state laws prohibiting discrimination in employment, e.g., Title VII of the 1964 Equal Employment Opportunity Act.
  • The American Hospital Association News reports,
    • “The Department of Health and Human Services Health Resources and Services Administration is accepting applications until April 22 for its four-year Rural Maternity and Obstetrics Management Strategies Program. HRSA will award up to three cooperative agreements for up to $1 million per year for establishing rural obstetric networks to improve maternity care and access in rural communities. The program runs from Sept. 30, 2025, through Sept. 29, 2029.”

From the judicial front,

  • Per Fierce Healthcare,
    • “The feds intend to appeal a judge’s decision that would force them to recalculate UnitedHealthcare’s Medicare Advantage (MA) star ratings.
    • “The Centers for Medicare & Medicaid Services (CMS) submitted a filing Tuesday in Texas district court saying that it would appeal the November ruling to the Fifth Circuit Court of Appeals. Further details were not included in the court filing.
    • “Judge Jeremy Kernodle of Texas’ Eastern District Court ruled on Nov. 22 that the CMS would have to recalculate UnitedHealth’s MA scores. 
    • “At the center of the case is a single foreign language test phone call that was made to one of UnitedHealthcare’s call centers. The CMS categorized the call as “unsuccessful” because it was disconnected before the test caller could fully engage with a customer service agent, according to UnitedHealth’s lawsuit, which was filed in early October.“
  • The Groom Law Group discusses pending ERISA litigation.

From the public health and medical research front,

  • USA Today reports,
    • “The beer, spirits and wine industries were already prepared for a continued lull in sales for 2025, then came the U.S. surgeon general’s call for cancer warning labels on alcoholic beverages.
    • “Add that buzz kill to a flight of other challenges facing the booze business: Dry January – and its sober-curious companion in fall, Sober October – along with the thriving year-round embrace of lower-alcohol and non-alcohol options, especially by younger consumers.
    • “Suddenly, moderation is sweeping the nation. Nearly half of Americans (49%) say they plan to drink less in 2025 – up from 41% who said that was their plan in 2024, according to a new survey, released Tuesday, commissioned by advertising and sales measurement technology firm NCSolutions.”
  • STAT News tells us,
    • “Immune checkpoint inhibitors, drugs that can help make the immune system recognize and destroy cancer more aggressively, are one of the most important medicines in cancer treatment today. Merck’s Keytruda has been used against dozens of different cancers in millions of patients, making it the top-selling drug in the world, with over $25 billion in revenue in 2023. Opdivo, from Bristol Myers Squibb, earned $10 billion in 2023.
    • “Now, a new class of drugs may be emerging to challenge the dominance of these first-generation checkpoint inhibitors. Experts said a certain type of bispecific antibody seems to have hit upon a crucial combination of two cancer targets: the proteins VEGF and either PD-1 or PD-L1. “It’s exactly that,” said Özlem Türeci, the CMO and co-founder of BioNTech. “I think that the anti-PD-1 or PD-L1 and VEGF concept can be a very broad, pan-tumor platform: the next-generation checkpoint modulator.”
  • MedPage Today informs us,
    • “Beneficial pediatric obesity treatment response was associated with a reduced risk of obesity-related events in young adults, a nationwide prospective cohort study in Sweden showed.
    • “Compared with poor response, good response to obesity treatment was associated with lower risk of type 2 diabetes (adjusted HR [aHR] 0.42, 95% CI 0.23-0.77), dyslipidemia (aHR 0.31, 95% CI 0.13-0.75), and bariatric surgery (aHR 0.42, 95% CI 0.30-0.58), reported Emilia Hagman, PhD, of the Karolinska Institute in Sweden, and colleagues.”
    • “Obesity remission showed similar reduced risks, as well as reduced risk of hypertension (aHR 0.40, 95% CI 0.24-0.65). Good response in obesity treatment or obesity remission was associated with a reduced risk of mortality (aHR 0.12, 95% CI 0.03-0.46), though treatment response was not associated with reduced risk for depression or anxiety, they noted in JAMA Pediatrics.
    • “The long-term effects of treating obesity in childhood were largely unknown,” Hagman told MedPage Today in an email. “Many people believe that because maintaining weight loss is so challenging, early treatment might not make a real difference in reducing the risk of serious health problems like type 2 diabetes, high blood pressure, or heart disease later in life. Our research helps answer this critical question and shows the importance of addressing obesity early.”
  • HCPLive adds,
    • “Patient factors, including sociodemographic, healthcare, and clinical elements, were linked to the initiation of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), in a population with obesity without type 2 diabetes (T2D).1
    • “Among more than 97,000 commercially insured adults in a recent cohort study, approximately 2.0% began semaglutide treatment within 6 months of an obesity diagnosis, with sex, insurance plan, and medication use found to be relevant factors for medication initiation.
    • “The association of these factors with semaglutide initiation were quantified using multivariable logistic regression, and use of common medications, insurance plan structure, employer industry type, and sex were all significantly associated with semaglutide initiation,” wrote the investigative team, led by Andrew C. Stokes, PhD, department of global health, school of public health, Boston University.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency exchange rates would temper sales growth this year.
    • “Adjusted earnings per share reached $2.04 in the fourth quarter, higher than the Wall Street consensus of $2.01 and Leerink Partners’ estimate of $1.96, Leerink analyst David Risinger wrote in a note to clients. The company’s sales rose 5.3% to $22.5 billion during the quarter, in line with estimates
    • “Full-year 2024 revenue increased to $88.8 billion from $85.2 billion in 2023. For this year, J&J expects revenue to climb to between $89.2 billion and $90 billion, with a mid-point of $89.6 billion, less than the consensus estimate of $91.1 billion. Shares of the company dropped about 3% in early trading Wednesday, even as the overall market rose.”
  • BioPharma Dive adds,
    • “Johnson & Johnson expects changes in Medicare’s prescription drug benefit will negatively impact its sales by about $2 billion this year, a modest headwind for a pharmaceuticals division the company anticipates will otherwise continue growing.
    • “The changes are the result of a redesign under the Inflation Reduction Act to Medicare’s Part D benefit, which covers outpatient drug treatment. The 2022 law capped annual out-of-pocket spending by people enrolled in Part D to $2,000 beginning this year, and required drugmakers provide additional discounts within certain phases of coverage, among other tweaks.
    • “J&J provided its estimate of the redesign’s financial impact Wednesday alongside earnings for the fourth quarter. In doing so, the company follows Pfizer, which late last year forecast the changes would have a $1 billion net negative impact on 2025 revenue.
    • “The Part D redesign brought on by the Inflation Reduction Act is proving consequential to drugmakers’ business even as the law’s provisions allowing Medicare to negotiate certain drug prices get more attention. Three drugs marketed in whole or in part by J&J were picked by the Biden administration for the first round of negotiations that wrapped up last summer.”
  • The American Hospital Association News points out,
    • “Baxter notified customers on Jan. 22 that allocations for two sodium chloride IV solutions have been increased to 100%. According to Baxter, the products will have a one- to two-week lag time while they progress through the full distribution network after implementing changes. AHA members have notified the association of two- to three-week lag times in some cases following previous allocation updates.”
  • Per Fierce Healthcare,
    • “Credit downgrades for nonprofit hospitals again outpaced upgrades across 2024, though the difference between the two narrowed compared to the year before, according to a review of three credit agencies’ rating actions published Wednesday.
    • “Moody’s, S&P and Fitch collectively issued 95 downgrades and 37 upgrades in 2024, as opposed to 116 and 33 in 2023, wrote Kaufman Hall Managing Director Lisa Goldstein.
    • “She and her firm expect the trend to continue into 2025 “given a growing reliance on government payers, labor challenges and a competitive environment.”
    • “Policy and funding changes will also cast uncertainty into the mix in 2025 and may cause credit deterioration in future years,” she wrote on Kaufman Hall’s website.”
  • Healthcare Dive adds, “Providers to target efficiency, supply chain resilience in 2025. Health systems will work to expand their supply chains and ink nontraditional partnerships in 2025, while trimming excessive AI programs and nonclinical staff.”
  • Meanwhile MedTech Dive notes, “AI in medtech is taking off. Here are 4 trends to watch in 2025. New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.”
  • Per a news release,
    • The Institute for Clinical and Economic Review (ICER) today announced a new analysis it plans to release on an annual basis titled the “Launch Price and Access Report” which will examine launch pricing for FDA-approved treatments. This report will review the affordability and access of the treatments and their value to the overall health system.
    • “There is no better time to provide an independent analysis on trends in launch pricing – both list and net – and patient access,” stated ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “ICER typically evaluates promising treatments that pose potential affordability challenges for the U.S. health system. Through this work, ICER will continue to work towards a health system where the pricing of innovative treatments are tied to value, while still ensuring affordability and access for patients.”  * * *
    • “The report is expected to be released in the fourth quarter of 2025.”
  • Alan Fein, in his Drug Channels blog, discusses “The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars.”

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The battle to empower the federal government to negotiate lower prices for Medicare enrollees was years in the making. The war has just begun. 
    • “After years of opposition from the pharmaceutical industry and lawsuits seeking to halt the law that led to the new prices, resistance paled and legal efforts failed. The talks settled into a sometimes testy back and forth: hundreds of pages of paperwork, offers and rejected counteroffers, then rounds of meetings in windowless rooms with strict rules on how many people could attend.
    • During the meetings, many manufacturers lowered counter offers while federal officials moved up from their initial offers, said Meena Seshamani, director of the Center for Medicare and a deputy administrator of Medicare’s parent agency, the Centers for Medicare and Medicaid Services.” * * *
    • “Round two is just around the corner. 
    • “Companies and officials are already preparing for negotiations over more drugs that could take a bigger bite out of high drug costs, and possibly their bottom lines. Next up are prices of 15 more drugs the government will identify by Feb 1. 
    • “The two sides are also fighting over how the talks should work. Among the drug industry’s demands: clarity on how CMS determines the price of a drug. Drug companies are also fighting the agency’s potential changes for next year, including possibly cutting back the number of in-person meetings to fewer than three.”
  • Federal News Network informs us,
    • “Scores of House Democrats are calling on the Postal Service to adopt stricter workplace protections for extreme heat.
    • “The 77 House Democrats are calling on USPS to “immediately implement” the standards in the workplace heat rule the Occupational Safety and Health Administration (OSHA) proposed last month.
    • “Proactively implementing this rule would save lives by ensuring that your workforce is protected with the most up-to-date heat safety standards,” the lawmakers wrote in a letter to Postmaster General Louis DeJoy.
    • “The proposed rule, if finalized, would be the nation’s first-ever federal heat rule.”
  • and
    • “Federal employees on official travel will soon enjoy another bump in reimbursable travel costs, as the General Services Administration has increased per diem rates for lodging and meals.
    • “Starting Oct. 1, the reimbursable daily limit will rise to $178, from $166 last year. This increase marks the third consecutive year feds saw lodging rates go up, while rates for meals and incidental expenses (M&IE) last went up in 2022.
    • “The standard per diem lodging rate within the continental United States (CONUS) went up from $107 to $110, while the rates for M&IE increased from a range of $59 to $79, to a range of $68 to $92.
    • ‘Agencies [and experience rated FEHB contractors] use per diem rates to reimburse employees for lodging and M&IE during official travel. Even with inflation growth in the U.S. now losing steam, the continued increase in per diem rates reflect the persistent rise in overall costs that Americans face across the board.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention tells us,
    • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • COVID-19
      • “Many areas of the country are continuing to experience increases in COVID-19 activity, though other areas are experiencing declines in COVID-19 activity following increases this summer. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.”
    • Influenza
    • RSV
      • “Nationally, RSV activity remains low.”
    • Vaccination
  • Minnesota CIDRAP adds,
    • “Nationally, wastewater detections of SARS-CoV-2 are at the very high level for the second straight week. The highest levels are still in the West and South, followed by the Midwest and the Northeast. The CDC’s latest update, however, shows downward trends from high levels in the South and Midwest.” 
  • The Washington Post reports,
    • “Federal authorities are preparing to approve updated coronavirus vaccines targeting the latest virus variants late next week, a move that could make shots available before Labor Day, according to a federal health official and a person familiar with the plans who spoke on the condition of anonymity to discuss a confidential process.
    • “The mRNA shots manufactured by Pfizer-BioNTech and Moderna designed to target the KP.2 variant can hit the market within days of approval by the Food and Drug Administration. A third protein-based vaccine made by Novavax, preferred by people who are cautious about mRNA vaccines or who have had bad reactions to them, will probably take longer to be approved and will be distributed in subsequent weeks, according to the federal health official.
    • “Consumers should be able to start getting shots at pharmacies within a week after approval and at doctor’s offices soon after.”
  • and
    • “The Food and Drug Administration on Friday authorized the first at-home [, over the counter,] syphilis test amid surging cases of the bacterial infection and calls from federal health officials for innovative strategies to detect the disease.
    • “The manufacturer, NowDiagnostics, anticipates the 15-minute test called First to Know, being available in pharmacies, major retail stores and online as early as September. FDA staff hailed the new product as an advancement in testing for sexually transmitted illnesses but noted that an additional test by a health-care provider is needed to confirm a positive result.
    • “Syphilis was nearly eliminated in the 1990s, but rates have since soared to a 70-year high. Between 2018 and 2022, cases rose nearly 80 percent, according to the most recent data from the Centers for Disease Control and Prevention.
  • Per BioPharma Dive,
    • “Pfizer and BioNTech on Friday said a combination flu and COVID-19 shot they’ve been developing met one of its main goals in a Phase 3 trial but missed another, leaving the vaccine’s future in doubt. 
    • ‘The study tested Pfizer and BioNTech’s vaccine against separately administered, marketed COVID and flu shots in more than 8,000 people between the ages of 18 and 64. While the combination vaccine spurred a comparable immune response against COVID and influenza A, it didn’t meet that mark against the “B” strain of the flu.  
    • “As a result, two companies are “evaluating adjustments” that would improve the vaccine’s performance against influenza B while discussing next steps with health authorities.”
  • STAT News adds,
    • “The National Institutes of Health said Thursday that an antiviral often used to treat mpox did not resolve patients’ symptoms faster than placebo in a randomized trial.
    • “The results are notable because the drug, tecovirimat, has rarely been studied clinically for mpox, despite its wide use during the 2022 and 2023 outbreaks in the U.S. and Europe.”  
  • The American Medical Association shares “Top health tips sleep medicine physicians want you to know.”
  • Per Healio,
    • “Among a select group of women with uterine factor infertility, uterus transplant was feasible and associated with a high live birth rate after successful graft survival, data from a case series show.
    • “In an analysis of the Dallas Uterus Transplant Study (DUETS), researchers also found that although adverse events were common, including complications requiring surgical intervention, infants born to women who received a uterine transplant had no congenital abnormalities or developmental delays, though follow-up of the cohort is ongoing.
    • “We show that uterus transplantation is not only feasible and safe, but also associated with a success rate that is comparable with and even favorable to other infertility treatments,” Liza Johannesson, MD, PhD, of the Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center, told Healio. “[What is] important is that the children born after uterus transplant are healthy and developing normally.”
  • Medscape offers an interview with a Harvard medical professor about preventing dementia.
    • “Hello. This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a new report on the preventability of dementia that is both exciting and paradigm-shifting. The new study, published in The Lancet by the Lancet Commission on Dementia, estimates that close to 50% of cases of dementia worldwide can be prevented or delayed by improving 14 modifiable risk factors.”

From the U.S. healthcare business front,

  • MedCity News discusses the future of retail healthcare.
  • Behavioral Health Business lists the 40 fastest growing behavioral health companies in the U.S.
  • Per Reuters,
    • “Older Americans are having little success getting prescriptions for weight-loss drug Wegovy covered by Medicare despite the federal healthcare program’s decision to pay for patients with obesity at risk of heart disease, according to their doctors.
    • “In interviews with Reuters, seven obesity and heart disease specialists from various parts of the United States said their prescriptions for the Novo Nordisk (NOVOb.CO), opens new tab drug have been denied repeatedly by the healthcare companies that administer Medicare drug benefits, with some prescriptions approved only following an appeal for each application.”
  • Per Fierce Healthcare,
    • “Massachusetts’ governor has announced that deals in principle have been reached for Steward Health Care’s four remaining hospitals in Massachusetts.
    • “Should the deals be finalized, Lawrence General Hospital will operate both campuses of Holy Family in Haverhill and Methuen. Lifespan would take over operations of Morton Hospital and Saint Anne’s Hospital. Boston Medical Center will take over operations of Good Samaritan Medical Center.
    • “Boston Medical Center also intends to operate Saint Elizabeth’s down the line. The state is first taking control of the hospital through eminent domain, according to an announcement from the governor’s office.”

Friday Factoids

David Ermer–CDC, Government Contracting, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The New York Times reports,
    • A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart.
    • The tiny Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions. * * *
    • “When reporting on outsize bleeding rates related to the Impella devices, Dr. Desai, of Yale, has also noted that its payments are far higher than the balloon pump, creating an urgent need for rigorous studies of how to best treat patients.
    • “You hate to think this is part of that story, but I think we would be naïve to think that that couldn’t be part of the story,” he said.”
  • The Labor Department’s Office of Federal Contractor Compliance Programs announced,
    • “Contractors that meet certain jurisdictional thresholds have an obligation to develop and maintain written Affirmative Action Programs (AAPs).
    • “The Contractor Portal is OFCCP’s platform where covered federal contractors and subcontractors must certify, on an annual basis, whether they are meeting their requirement to develop and maintain annual AAPs. The portal allows multiple users from individual organizations to register, manage records, and certify each establishment and/or functional/business unit, as applicable.
    • “Beginning April 1, 2024, federal contractors will be able to certify the status of their AAPs for each establishment and/or functional/business unit, as applicable. The deadline for certifying compliance is July 1, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 9 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high or very high activity the previous week. This week no jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.   
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.  
    • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, remains low.
    • “Reported on Friday, March 29th, 2024.“
  • The Hill informs us,
    • “Tuberculosis rates in the U.S. rose by 16 percent in 2023, marking the third year that cases went up following nearly 30 years of decline.
    • In the most recent Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC), the number of TB cases in 2023 totaled at 9,615, a jump of 1,295 over 2022.
    • “The last time annual TB cases in the U.S. were higher than 9,500 was in 2012, when 9,906 were detected. As the report noted, TB cases had declined for 27 years, reaching a record low of 7,171 in 2020 before creeping back up.
    • “While there is a vaccine for tuberculosis, the CDC notes that it’s mostly used in countries with a high prevalence of TB and isn’t recommended for use in the U.S. due to low risk of infection.
    • “In a January report to Congress, the United States Agency for International Development attributed the rise in TB cases globally to the disruptions brought on by the COVID-19 pandemic.
    • “After two years of COVID-19-related disruptions to TB prevention, diagnosis, and treatment efforts, 2023 had the highest number of people diagnosed and started on treatment since the beginning of the disease’s global monitoring in 1995 that affected access to and provision of health services – due in part to concerted efforts to recover from the pandemic’s devastating global impact,” the agency said.”
  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention issued a health advisory Thursday [March 27] about a rise in rare but severe forms of meningococcal infections. These bacterial infections can cause potentially life-threatening inflammation of the membranes surrounding the brain and spinal cord.
    • “The CDC says 422 cases were reported in 2023, the highest annual number seen since 2014. Of the 94 cases with known outcomes, 17 died. Since March 25, 143 cases have been reported to the CDC — 62 more cases than what was seen over the same time period in 2023.
    • “The spike is notable in part because infections are disproportionately affecting people ages 30 to 60, as well as African American individuals and those with HIV. Typically, infants younger than 1, teenagers and young adults ages 16 to 23 as well as individuals older than 85 have a higher risk of contracting meningococcal disease.
    • “The agency says health-care experts should increase monitoring for meningitis symptoms, and the public should take steps to prevent its spread.
    • “We’re not recommending any unusual precautions,” said Lucy McNamara, an epidemiologist in the meningitis and vaccine-preventable diseases branch at the CDC.
    • “We would like for the general public to be aware of the symptoms of meningococcal disease and to contact their health-care provider if they or members of their family have those symptoms,” she said, adding that officials also “want to make sure that they’re up to date for meningococcal vaccinations.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb’s cancer pill Krazati helped people with a certain kind of non-small cell lung cancer live longer without their disease progressing and shrank tumors at a higher rate than those given chemotherapy, the company said Thursday.
    • “The data could help Bristol Myers persuade the Food and Drug Administration to convert Krazati’s conditional approval into a full clearance, potentially giving it an advantage over Amgen’s rival drug Lumakras. Amgen’s bid to gain confirmatory approval was unsuccessful, and the company has four years to complete another trial testing its pill.
    • “Both Krazati and Lumakras target tumors harboring a mutation in a gene called KRAS — a long-sought goal of drugmakers. While their uptake is currently modest, both Bristol Myers and Amgen are working to expand their use into earlier lines of treatment and other types of cancer.”

From the U.S. healthcare business front,

  • CNN calls our attention to the fact
    • “For the first time, women in the US can walk into a store and buy a supply of birth control pills right off the shelf, without the need for a prescription or health insurance.
    • “Opill, the first oral contraceptive approved by the US Food and Drug Administration for over-the-counter use, has arrived at most stores in certain retail pharmacy chainssuch as CVS, Walgreens and Walmart.
    • “The product is “is now available at CVS.com and through the CVS Pharmacy app and is arriving at more than 7,500 CVS Pharmacy stores in the coming weeks,”spokesperson Matt Blanchette said in an email. “For added privacy and convenience, customers will be able to choose same-day delivery or buy online and pick-up in store.”
    • “Walgreens began offering Opill in late March, spokesperson Samantha Stansberry said.
    • “The product “will be available at Walgreens nationwide in the family planning aisle and behind the pharmacy,” Stansberry said in an email. “Customers can also purchase the product online for 30-minute Pickup, 1-hour Delivery, or ship to home.”
    • “At Walmart, “it is currently available on walmart.com and will be in stores in early April,” spokesperson Tricia Moriarty said in an email.”
  • Kaufmann Hall issued its March National Hospital Flash Report on March 27.
    • “Key Takeaways
      • “Margins this month were at 3.96%, continuing a strong start to 2024. However, data
        this month do not reflect the full impact of the Change Healthcare outage, which
        began February 21st.
      • “Gross revenue continues to rise at a faster rate than net revenue, highlighting payer
        mix changes. Bad debt and charity care have also risen over the last few years.
      • “Revenue growth is primarily being driven from the outpatient setting. There
        continues to be a decline in inpatient revenue and increase in outpatient revenue.”
  • STAT News lets us know,
    • “Diabetes drugs are too expensive in the U.S., and insulin is infamously six to 13 timesmore expensive here than in comparable high-income countries. And blockbuster GLP-1 drugs, too, could be a lot less expensive, according to an investigationpublished this week in JAMA Network Open, with a simple change: robust generic competition.
    • “The study, led by Melissa Barber, a Yale postdoctoral fellow, and conducted in collaboration with Doctors Without Borders, a nonprofit medical organization working in low-resource and emergency settings, found that making a generic vial of insulin could cost $61 to $111 per year — 97% less than than the current market price in the U.S., based on an estimate that factors in a 10% to 50% profit margin. * * *
    • “Findings for the cost of making GLP-1 biosimilars were along the same lines. Researchers calculated that the cost of producing a patient’s monthly supply of a GLP-1 drug would range from $0.75 to $72.50; currently, Ozempic costs about $1,000 a month in the U.S, $155 in Canada, and less than $60 in Germany, according to a statement by Sen. Bernie Sanders, who cited the study as evidence of pharmaceutical overpricing and called on Novo Nordisk to lower the price of Ozempic.”
  • and
    • “The staff of the Institute for Clinical and Economic Review, or ICER, are known as the nerds of the drug industry: bespectacled killjoys who emerge a few times a year to scold drugmakers for pricing their latest cancer or MS advance far beyond reason.
    • “But last year, they sat down and concluded a forthcoming treatment was worth up to $3.9 million — more than any medicine in history, more than a 45-year supply of Humira, the autoimmune drug often held up as an emblem of America’s runaway drug spending. 
    • “It was a testament to the power of a new class of gene therapies to deliver something pharma so rarely does: Genuine cures. The treatment, approved last week as Lenmeldy, may allow some babies born with an ultra-rare neurodegenerative disease called metachromatic leukodystrophy, or MLD, to grow up and live essentially normal lives.
    • “David Rind, ICER’s chief medical officer, compared Lenmeldy to Zolgensma, a gene therapy approved in 2019 for spinal muscular atrophy that the nonprofit estimated could be worth up to $2.1 million. * * *
    • “Lenmeldy, Rind said, is still overpriced. Orchard Therapeutics, Lenmeldy’s developer, is tacking on an additional $325,000, for a $4.25 million total. But its price falls closer to those estimates, as a percentage, than the vast majority of medicines it reviews.”
  • Healthcare Dive brings us “inside CVS Health’s push to transform customer experience. The transformation, led by Deloitte Digital, focused on increasing customer feedback to identify pervasive issues and closing the loop on customer inquiries.”
  • Beckers Payer Issues relates,
    • “UnitedHealth Group has named CFO John Rex as president of the company. 
    • “Mr. Rex is taking over the president role from COO Dirk McMahon, who plans to retire. UnitedHealth Group has not announced a successor in the COO role. Mr. McMahon spent 20 years in various leadership positions at UnitedHealth Group, and was named president and COO in 2021.  
    • “According to a March 28 regulatory filing, Mr. Rex will assume the president role April 1, in addition to his current position as CFO.” 

Happy Leap Day!

David Ermer–CDC, Congress, Cybersecurity, Government Contracting, Medicare, Mental health care, Obesity, SDOH, U.S. Healthcare–
Photo by Joe Caione on Unsplash

From Washington, DC,

  • Politico reports,
    • “The Senate approved a stopgap funding bill Thursday night for President Joe Biden’s signature, thwarting a partial government shutdown on Saturday and buying more time to finalize half a dozen spending bills that congressional leaders aim to pass next week.
    • “Congress now officially has until March 8 to clear that initial six-bill bundle, which leaders struck a deal on earlier this week. But they’re still working on an agreement to fund the rest of the government, including the military and some of the biggest domestic programs, before a second deadline on March 22. The upper chamber cleared the measure in a 77-13 vote, following votes on four Republican amendments that were defeated on the floor.”
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan concerning Primary Care Interventions for Tobacco and Nicotine Use Prevention and Cessation in Children and Adolescents. The comment period ends on March 27, 2024.
  • The Labor Department’s Office of Federal Contract Compliance Programs created an updated website for the “The Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA) [which] is a law that prohibits federal contractors and subcontractors from discriminating in employment against protected veterans and requires employers take affirmative action to recruit, hire, promote, and retain these individuals.”
  • Yesterday, the Politico Pulse posted a story on a December 2022 Government Accountability Office report, released January 9, 2023, criticizing OPM’s internal controls over FEHB family member eligibility. Here is a link to the GAO’s website for the report which offers August 2023 updates on OPM’s efforts to implement GAO’s recommendations. Here’s are FEHBlog recommendations for GAO and OPM:
    • Family member eligibility hinges on the enrollee’s eligibility. OPM needs to have the payroll offices implement the HIPAA 820 enrollment roster electronic transaction which allows carriers to reconcile premiums to actual headcount. Use of the HIPAA 820 will be a huge step toward confirming the accuracy of family member eligibility and the 50% of FEHB enrollees who have self only coverage.
    • The Politico article suggests that the high cost of a family member eligibility audit discourages OPM from implementing one for the FEHBP. Auditors do their work based on samples. Arrange for a family member eligibility audit using statistically appropriate samples which will disclose, at the very least, the scope of the problem.

From the U.S. public health and medical research front,

  • The New York Times reports,
    • “Long Covid may lead to measurable cognitive decline, especially in the ability to remember, reason and plan, a large new studysuggests.
    • “Cognitive testing of nearly 113,000 people in England found that those with persistent post-Covid symptoms scored the equivalent of 6 I.Q. points lower than people who had never been infected with the coronavirus, according to the study, published Wednesday in The New England Journal of Medicine.
    • “People who had been infected and no longer had symptoms also scored slightly lower than people who had never been infected, by the equivalent of 3 I.Q. points, even if they were ill for only a short time.
    • “The differences in cognitive scores were relatively small, and neurological experts cautioned that the results did not imply that being infected with the coronavirus or developing long Covid caused profound deficits in thinking and function. But the experts said the findings are important because they provide numerical evidence for the brain fog, focus and memory problems that afflict many people with long Covid.”
  • and
    • “Alcohol-related deaths surged in the United States by nearly 30 percent in recent years, with roughly 500 Americans dying each day in 2021, according to a new study published by the Centers for Disease Control and Prevention.
    • “The study chronicled a sustained spike in drinking during the Covid pandemic that continued to rise after the shock of the lockdowns of 2020. The incidence of alcohol-related deaths was higher in men, but among women the death rate shot up at a quicker pace.
    • “I think the results of this research are really alarming,” said Dr. Michael Siegel, who is a professor of public health at Tufts University School of Medicine and was not involved in the study. “It shows that there’s been a truly substantial increase in alcohol-related deaths over the last six years.”
  • and
    • “The 2022 outbreak of mpox, previously known as monkeypox, was curbed in large part by drastic changes in behavior among gay and bisexual men, and not by vaccination, according to a new analysis published on Thursday in the journal Cell.
    • “Public health response to outbreaks often relies heavily on vaccines and treatments, but that underestimates the importance of other measures, said Miguel Paredes, lead author of the new study and an epidemiologist at the Fred Hutchinson Cancer Center in Seattle.
    • “Although the Food and Drug Administration approved a vaccinefor mpox in 2019, getting enough doses produced and into arms proved challenging for many months after the outbreak began. Vaccines for new pathogens are likely to take even longer.
    • “The new analysis suggests an alternative. Alerting high-risk communities allowed individuals to alter their behavior, such as reducing the number of partners, and led to a sharp decrease in transmission, Mr. Paredes said. In North America, the outbreak began petering out in August 2022, when less than 8 percent of high-risk individuals had been vaccinated.
    • “Public health messaging can “be really powerful to control epidemics, even as we’re waiting for things like vaccines to come,” he said.”
  • Roll Call adds,
    • “Cases of measles are rising across the country and seem to be striking counties at random, but experts say there is one thing the public health system can do to turn the tide, and that’s to stem the post-pandemic vaccine lag and get parents to vaccinate their kids.
    • “General vaccination rates, including measles vaccination, declined during the COVID-19 pandemic, as people had less access to health care and kids were unable to access in-school vaccine clinics.
    • “That, combined with a new wave of vaccine skepticism and anti-vaccine sentiment has contributed to a wave of unvaccinated kids falling sick with the once-eradicated virus.”
  • MedPage Today tells us,
    • “The benefits of vaccination against respiratory syncytial virus (RSV) for adults ages 60 and older probably outweigh the small risk of vaccine-related Guillain-Barré syndrome (GBS), the CDC’s Advisory Committee on Immunization Practices (ACIP) reaffirmed.
    • “In a presentation on the second day of the ACIP’s 2-day meeting, Amadea Britton, MD, of the CDC’s RSV adult vaccination work group in Atlanta, noted that a small number of cases of Guillain-Barre syndrome had been observed in the clinical trials for both FDA-approved RSV prefusion F protein vaccines, but that it remained unclear whether those cases were actually caused by RSV vaccination or just chance occurrences.”
  • and
    • The CDC has issued new guidance —  its first since 1988 — on identifying and responding to clusters of suicide, as tens of thousands of lives are lost to suicide each year in the U.S.
    • Though suicide clusters are rare, they “can have unique characteristics and challenges,” and “are often highly publicized and can have considerable negative effects on the community, including prolonged grief and elevated fear and anxiety about further deaths,” Michael Ballesteros, PhD, of CDC’s National Center for Injury Prevention and Control (NCIPC), and colleagues wrote in Morbidity and Mortality Weekly Report (MMWR).
  • Beckers Hospital Review informs us,
    • “The CDC is anticipating a shortage of Td vaccines — which protect against tetanus and diphtheria — as the maker of one shot has discontinued production. 
    • “As a result, the CDC has updated guidance for providers and is recommending that they switch to administering Tdap vaccines, which protect against pertussis in addition to tetanus and diphtheria, whenever possible.  
    • “MassBiologics discontinued production of its TdVax shot, and while Sanofi also manufactures a Td vaccine and is working to boost supplies, the CDC anticipates the U.S. could see a shortage of the vaccines later this year. 
    • “Because not everyone can receive the Tdap vaccine, “the limited supply of Td vaccine needs to be preserved for those with a contraindication to receiving pertussis-containing vaccines,” the CDC said in its guidance.” 
  • Medscape notes,
    • “Injectable weight loss drugs like Wegovy, Saxenda, and Zepbound have been getting all the glory lately, but they’re not for everyone. If the inconvenience or cost of weight loss drugs isn’t for you, another approach may be boosting your gut microbiome.
    • “So how does one do that, and how does it work?
    • “In theory, all you have to do is boost your gut microbiome.
    • “There are a lot of different factors naturally in weight gain and weight loss, so the gut microbiome is certainly not the only thing,” said Chris Damman, MD, a gastroenterologist at the University of Washington. He studies how food and the microbiome affect your health. “With that caveat, it probably is playing an important role.”
  • STAT News adds,
    • “New obesity drugs like Wegovy and Zepbound are currently taken once a week, indefinitely. But what if they could be taken once a year instead, like a vaccine?
    • “That’s a question that Novo Nordisk, the pharma company behind Wegovy, is exploring as it faces increased competition from other drugmakers aiming to develop similar GLP-1-based treatments for obesity.
    • “We have a very early think tank on: what would it take us, from a technology point of view and from an ecosystem point of view, to make long-lasting GLP-1 molecules?” Marcus Schindler, Novo’s chief scientific officer, said in an interview with STAT Wednesday. “Could we think about vaccine-like properties, where imagine you had, once a year, an injection with an equivalent of a GLP-1 that really helps you to maintain weight loss and have cardiovascular benefits?”

From the U.S. healthcare business and cybersecurity issues front,

  • Beckers Hospital Review informs us,
    • “Optum’s Change Healthcare confirmed Feb. 29 that it was hacked by a ransomware gang after the group claimed to have stolen massive amounts of data.
    • “Change Healthcare can confirm we are experiencing a cybersecurity issue perpetrated by a cybercrime threat actor who has represented itself to us as ALPHV/Blackcat,” an Optum spokesperson emailed Becker’s on Feb. 29. “We are actively working to understand the impact to members, patients and customers.” * * *
    • “ALPHV/Blackcat, aka BlackCat, claimed responsibility for the hack, posting on its dark web leak site that it stole 6 terabytes worth of Change Healthcare data involving “thousands of healthcare providers, insurance providers, pharmacies, etc,” Bleeping Computer reported Feb. 28. The allegedly stolen data includes medical records, patient Social Security numbers, and information on active military personnel (Change serves some military healthcare facilities).
    • “But as Politico noted Feb. 28: “Ransomware groups, which demand extortion payments in exchange for restoring or not publishing stolen data, often exaggerate their exploits as a negotiating tactic.”
    • “ALPHV/Blackcat, which has been linked to Russia, has been targeting the U.S. healthcare industry since December after the FBI disrupted its operations.”
  • STAT News adds,
    • “The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT.
    • “UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline. He said that program will last “for the next couple of weeks as this continues to go on.”
    • “McMahon’s remarks about the loan program highlight the scope of UnitedHealth’s damage control. UnitedHealth maintained it has “not determined the [cyberattack] incident is reasonably likely to materially impact our financial condition or results of operations,” according to its annual report to investors this week. But doctors and pharmacists are scrambling to find ways to get patients what they need, and to get paid. As of 2022, Change facilitated $1.5 trillion in health care transactions.”
  • HR Brew lets us know,
    • “The cost of healthcare went up last year, according to a new report from Marsh McLennan Agency (MMA), a US-based subsidiary of global brokerage Marsh. The amount that employers spent on health benefits per employee grew by 5.2%, while the estimated cost of employer contributions to premiums increased by more than $1,400, to $11,762.
    • “Healthcare inflation can affect employees, as well, the report noted, with 38% of Americans reporting they put off medical treatment in the last year due to cost concerns. MMA noted that “delayed care is associated with worse health outcomes and higher costs for patients and benefit providers.”
    • “Younger workers appear to be feeling the pinch of high health costs the most, with 74% of millennial and 56% of Gen Z patients canceling doctors’ visits because of high costs, compared to 13% of Baby Boomer patients. Putting off behavioral healthcare, in particular, can be costly for younger age groups, said Monte Masten, chief medical officer with MMA. Given these trends, employer investment in incentives may be warranted, he told HR Brew.”
  • Drug Store News alerts us,
    • “Walgreens’ VillageMD is closing six Chicago clinic locations—five standalone and one co-located with a Walgreens store, per a Telehealth & Telecare Aware report.
    • “The closures in Walgreens’ home state are set to take place April 19. These closures follow on the heels of news last week that VillageMD exited the Florida market.” 
  • Per Fierce Healthcare,
    • “Telemedicine clinic Virta Health believes its members can achieve significant and sustained improvement in weight loss, even if a patient has stopped taking a GLP-1 drug, a newly released paper in Diabetes Therapy shows.
    • “According to the company, it is a first-of-its-kind study offering an opposing viewpoint against clinical trials showing GLP-1 deprescription leading to weight regain. The results have potentially major implications for employers and plans looking to help its members improve health outcomes and fight obesity but that are concerned about rising costs amid increasing demand.
    • “This is unheard of,” said Sami Inkinen, Virta Health CEO and co-founder. “To my knowledge, nobody has published or shown this kind of data to date.”
  • Beckers Health Payer Issues points out five health insurers that “are making commitments to advance a White House initiative to end hunger and reduce diet-related disease by 2030.” 
  • Per BioPharma Dive,
    • “Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders.
    • “Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round announced Thursday, alongside Alaska Permanent Fund Corporation and The Column Group. The investment is the first announced by Cure since it debuted last year with a $350 million fund. Euclidean Capital and Saisei Ventures also participated in the round.
    • “Previously known as Ryne Bio, Kenai’s research aim is to create so-called off-the-shelf cell therapies that replace neurons. The company’s most advanced medicine is made from genetically reprogrammed stem cells and designed to treat Parkinson’s disease by restoring dopamine production.
    • “The medicine has “displayed robust survival, innervation, and behavioral rescue in preclinical models of Parkinson’s disease,” according to Kenai, which claims it could work in inherited forms of the disease as well as in cases where the exact cause isn’t understood.
    • “The company said the funding proceeds will be enough to push the medicine, named RNDP-001, into human testing and through early-stage clinical trials, which should start within the year.”

Weekend Update

David Ermer–Congress, Federal employment benefits, Government Contracting, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The House of Representatives and the Senate continue to engage in Committee business and floor voting this week. The Committee for a Responsible Federal Budget reminds us
    • “The [current continuing resolution (CR)] measure extends the “laddered” approach from the previous CR, with the first set of appropriations bills expiring on Friday, March 1: Agriculture, Energy-Water, Military Construction-VA, and Transportation-HUD (these were previously set to expire Jan. 19). The second set of appropriations bills would expire a week later, on Friday, March 8: Commerce-Justice-Science, Defense, Financial Services-General Government, Homeland Security, Interior-Environment, Labor-HHS-Education, Legislative Branch, and State-Foreign Operations bills (these were previously set to expire Feb. 2).”
  • On February 1, The Government Accountability Office
    • “issue[d] a new revision of the Generally Accepted Government Auditing Standards, also known as the “Yellow Book,” which supersedes the 2018 revision of the standards. The Yellow Book is the book of standards and guidance for government auditing—outlining the requirements that make for effective, quality audits when reviewing government programs and spending. It’s used by our federal government auditors here at GAO, as well as federal, state and local auditors; inspectors general; and auditors of entities that receive government awards. 
  • The February 1 WatchBlog post takes a closer look at this important guidance and GAO’s updates.
  • Independent auditors base their audits of experience rated FEHB plans on the Yellow Book and related OPM guidance.
  • Last Tuesday, the Accreditation Association for Ambulatory Healthcare (AAAHC) released its updated FEHB Accreditation Handbook. Employee organization plans in the FEHB Program are accredited by AAAHC.
  • Reg Jones, writing in FedWeek, offers primers on annual leave and sick leave for federal and postal employees.

From the public health front,

  • The Wall Street Journal reports,
    • “Medical centers are starting programs to identify patients’ chances of cognitive decline and recommend ways to delay or prevent it. Most patients are in their 40s to 60s; some clinics take patients as young as 18. Insurance covers some services, otherwise tests and visits can range from hundreds to thousands of dollars.
    • “Doctors in these clinics counsel patients to make personalized lifestyle changes, such as building resistance training into workouts or eating more leafy greens. They also recommend medications to treat conditions linked to Alzheimer’s risk, such as statins for high cholesterol. There’s no guarantee of preventing the disease or other forms of dementia, however, and some doctors are skeptical of these programs. * * *
    • “If every primary-care doctor in every primary-care practice did prevention well, then this program may not need to exist,” says Dr. Zaldy Tan, who heads the new Memory & Healthy Aging Program at Cedars-Sinai. “But we know that that doesn’t happen.” 
  • MedTech Dive tells us,
    • Medical devices patients can use at home, such as infusion pumps and ventilators, are the top health technology hazard of 2024, a nonprofit patient safety organization said Wednesday.
    • ECRI named at-home devices as the top hazard in response to examples of harms such as medication errors with the use of infusion pumps that suggest products “may be too complex for laypeople to use safely and effectively.”
    • The group identified inadequate or onerous device cleaning instructions as the second biggest hazard of the year, reflecting evidence that reprocessing failures can spread infections.

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing.
    • “The fund, which would be Arch’s 13th, is being put together less than two years after the firm closed a similar-sized $3 billion raise that was its largest to date. Plans were outlined in a filing Arch made this week with the Securities and Exchange Commission. The form was signed by Arch managing director and CFO Mark McDonnell.
    • “Arch declined to comment on the filing.”
  • The New York Times reports
    • “A sharp shift in health care [spending?] is taking place as more than one-third of American adults now supplement or substitute mainstream medical care with acupuncture, meditation, yoga and other therapies long considered alternative.
    • “In 2022, 37 percent of adult pain patients used nontraditional medical care, a marked rise from 19 percent in 2002, according to research published this week in JAMA. The change has been propelled by growing insurance reimbursement for clinical alternatives, more scientific evidence of their effectiveness and an increasing acceptance among patients.
    • “It’s become part of the culture of the United States,” said Richard Nahin, the paper’s lead author and an epidemiologist at the National Center of Complementary and Integrative Health, a division of the National Institutes of Health. “We’re talking about the use for general wellness, stress management use, sleep, energy, immune health.”
    • “And for pain management. The use of yoga to manage pain rose to 29 percent in 2022 from 11 percent in 2002, an increase that Dr. Nahin said reflected in part efforts by patients to find alternatives to opiates, and the influence of media and social media.”
  • Fortune Well adds,
    • “According to the Global Wellness Summit’s 2024 trends report from the Global Wellness Institute, which combines research and insights from experts in the field—including scientists, CEOs, and academics—the wellness market is surging. And it’s not expected to slow down anytime soon. 
    • “The U.S. tops the global list of countries for spending on wellness, amassing an annual market of $1.8 trillion, up 14% since 2020. On average, people in the U.S. spend $5,321 per year on wellness, coming in 5th behind the Seychelles, Switzerland, Iceland, and Aruba.”         

Friday Factoids

David Ermer–COVID-19, FDA, Government Contracting, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC,

  • Govexec informs us,
    • “According to the Biden administration’s quarterly update of its progress in fulfilling the President’s Management Agenda, released last month, the White House is keeping pace with its stated goals of strengthening the federal workforce and modernizing customer experience. 
    • “The latest Performance.gov post touts 5,800 new hires targeted for roles created by the Bipartisan Infrastructure Law and promises eight new pooled hiring efforts to support multi-agency hiring in fiscal 2024, amid other milestones situated across multiple strategy goals. 
    • “Likewise, the goal of making it easier for the public to interact with the federal government’s life experience services is progressing with the stand-up of several pilot programs, and its High Impact Service Providers are aligning operations and workforce capacity to eventually begin reporting customer feedback data.” 
  • BioPharma Dive reports,
    • “For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers there.
    • “The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the safety and supply of medicines shipped from abroad. Supporters have argued that importing drugs from Canada, where medicines cost far less than in the U.S., could help rein in pharmaceutical costs. * * *
    • “The pharmaceutical industry, which has vehemently opposed importation plans, may also sue to block Florida’s plan.
    • “We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” a spokesperson for the industry lobby PhRMA said in an email. “PhRMA is considering all options for preventing this policy from harming patients.”
  • Note the FEHBlog is ambivalent about this decision.
  • The Federal Times discusses a contract protest related delay in implementing new TRICARE contracts.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid is surging again, four years after the pandemic began, as a new virus subvariant becomes dominant in the U.S. and as people gather indoors to escape cold weather.
    • “Rising wastewater virus levels and hospitalizations underscore the latest winter Covid surge. One driver is JN.1, the latest offshoot of the virus to take over in the U.S. and an Omicron subvariant. The Centers for Disease Control and Prevention on Friday estimated that JN.1 represents roughly 62% of cases nationwide.
    • “The good news is measures of severe illness—hospitalizations and deaths—remain below last winter’s highs and far lower than the pandemic’s peaks. But the virus remains dangerous for some and a major nuisance for many as people return to work and school after holiday breaks.
    • “The world has seen a steady cycle of new Omicron subvariants ever since that offshoot rapidly took over more than two years ago. When new versions become dominant, it indicates that they have some advantage, whether through their ability to evade immune defenses or easily spread from person to person.”
  • The FEHBlog credits Omicron for being an upper respiratory infection, which is much less dangerous than the initial waves of Alpha and Delta Covid, which were lower respiratory infections.
  • The CDC’s FluView notes,
    • “Seasonal influenza activity is elevated and continues to increase in most parts of the country.
    • “Outpatient respiratory illness has been above baseline1 nationally since November and is above baseline in all 10 HHS Regions.
    • “The number of weekly flu hospital admissions continues to increase.
    • “During Week 52, of the 651 viruses reported by public health laboratories, 581 (89.2%) were influenza A and 70 (10.8%) were influenza B. Of the 342 influenza A viruses subtyped during Week 52, 300 (87.7%) were influenza A(H1N1) and 42 (12.3%) were A(H3N2).”
  • Behavioral Health Business discusses
    • “How Fentanyl has changed Opioid Use Disorder Treatment,”
  • and
    • “Top behavioral health trends for 2024.”
  • The American Medical Association offers top health tips obesity medicine physicians want you to know.
  • The National Institutes of Health Director announced in her blog,
    • “Nearly 35 million people in communities across the U.S. have type 2 diabetes (T2D), putting them at increased risk for a wide range of serious health complications, including vision loss, kidney failure, heart disease, stroke, and premature death.1 While we know a lot about the lifestyle and genetic factors that influence diabetes risk and steps that can help prevent or control it, there’s still a lot to learn about the precise early events in the body that drive this disease.
    • “When you have T2D, the insulin-producing beta cells in your pancreas don’t release insulin in the way that they should. As a result, blood sugar doesn’t enter your cells, and its levels in the bloodstream go up. What’s less clear is exactly what happens to cause beta cells and the cell clusters where they’re found (called islets) to malfunction in the first place. However, I’m encouraged by some new NIH-supported research in Nature that used various large datasets to identify key signatures of islet dysfunction in people with T2D.”
  • The NIH further announced,
    • “Semaglutide, a highly popular medication approved by the U.S. Food and Drug Administration to treat obesity and manage type 2 diabetes, was associated with a 49% to 73% lower risk of first-time or recurring suicidal ideations compared to other medications for controlling obesity and type 2 diabetes that work via different mechanisms. These findings provide evidence that semaglutide – which helps regulate appetite and insulin levels by targeting glucagon-like peptide 1 receptors (GLP1R) in the body – does not appear to increase the risk of suicidal ideation, contrary to the claims of some anecdotal reports. Published today in Nature Medicine and paired with a related Research Briefing(link is external), the study was co-led by scientists at Case Western Reserve University and the National Institute on Drug Abuse (NIDA), National Institutes of Health.”
  • Per the American Medical Association,
    • “The AP (1/4, Neergaard) reports, “Seizures during sleep are a potential cause of at least some cases of sudden unexplained death in childhood, or SUDC, researchers at NYU Langone Health reported Thursday after analyzing home monitoring video that captured the deaths of seven sleeping toddlers.” The study “offers the first direct evidence of a seizure link,” although “scientists also have found that a history of fever-related seizures was about 10 times more likely among the children who died suddenly than among youngsters the same age.” The findings were published in the journal Neurology.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “The cost of treating a COVID-19 hospital patient in the hospital rose by 26% over the first two years of the pandemic, more than five times the rate of medical inflation during that time, according to a newly published analysis of 1.3 million admissions.
    • “On average and after adjustments, direct treatment costs for a COVID-19 hospital admission rose from $10,394 in March 2020 to $13,072 in March 2022, a gain that researchers said landed alongside increased use of breathing assistance machines.
    • “Such technologies proved to be costly; stays in which a COVID-19 patient required extracorporeal membrane oxygenation (ECMO), for instance, averaged $36,484 and increased by 35% over the course of the study period, they wrote in JAMA Network Open.
  • Forbes reports,
    • “Health insurance giant Elevance Health said it has agreed to acquire Paragon Healthcare, Inc., a provider of infusion services to patients.
    • “Elevance said Paragon provides infusion services to patients through its “omnichannel model of ambulatory infusion centers, home infusion pharmacies, and other specialty pharmacy services.” Financial terms of the deal for privately held Plano, Texas-based Paragon were not disclosed.
    • “It’s the latest effort by Elevance Health to bolster its specialty pharmacy business and pursue its strategy to treat the whole health of the person. Last year, Elevance Health, which operates Blue Cross and Blue Shield health plans in 14 states, closed on its acquisition of BioPlus, a specialty pharmacy.”
  • Healthcare Dive reports,
    • “Tom Cowhey, a financial executive at CVS who stepped into the interim CFO role late last year, has been permanently named to the post, the company announced on Friday.
    • “In October, Cowhey replaced Shawn Guertin, who served as CFO and president of health services. Guertin, who has been on a leave of absence due to family health reasons, will now officially leave CVS later this year, the company said. 
    • “Cowhey joined CVS in early 2022 after previously serving as CFO of Surgery Partners. Before that, he worked at Aetna in strategy and finance positions, before the health insurer was acquired by CVS.”
  • The American Medical Association lets us know,
    • “Significant changes in the Current Procedural Terminology (CPT®) code set for immunizations reflect the changing nature of how COVID-19 is being addressed as actions transition from a public health emergency response to combatting emerging variants much like the flu.
    • “One significant change involves the consolidation of more than 50 previous codes to streamline reporting of immunizations for COVID-19. A new vaccine-administration code, 90480, was approved for reporting the administration of any COVID-19 vaccine for any patient. This replaces all previously approved, product-specific vaccine-administration codes. * * *
    • “Additionally, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an advisory group of the FDA, recommended that the COVID-19 vaccine for the 2023–2024 vaccination season be a monovalent vaccine that contains the XBB.1.5 strain, and noted that a number of COVID-19 vaccine products will no longer be recommended for use. The streamlined structure brings greater alignment between CPT and the current COVID-19 vaccine reporting environment.
    • “The new coding system will allow for new vaccines for new variants whenever they come up without having to do a new code,” said Samuel “Le” Church, MD, MPH, a member of the CPT Editorial Panel and vice-chair of its Immunization Coding Caucus.”
  • Mercer Consulting offers seven breakthrough benefit strategies to explore this year.

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Government Contracting, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network offers its periodic update on the bills pending before Congress of interest to federal employees.
  • American Hospital Association News tells us that today
    • “The Department of Health and Human Services’ Office for Civil Rights released a proposed rule intended to update and clarify requirements under Section 504 of the Rehabilitation Act that prohibit discrimination on the basis of disability in programs receiving financial assistance from the department, including health care. According to HHS, the proposed rule would ensure that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities; prohibit the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when used to limit access or to deny aids, benefits and services; establish enforceable standards for accessible medical diagnostic equipment; and clarify obligations for accessible web and mobile applications and obligations to provide services in the most integrated setting appropriate to an individual’s needs. The rule will be published in the Sept. 14 Federal Register, with comments accepted for 60 days.”
  • The Federal Times points out
    • “The Office of Personnel Management received a small surge of retirement claims in July and August after applications had been falling steadily for months since January.
    • “The time it took the government to process retirements increased sharply in July to 85 days before falling back down to 74 days in August, according to data kept by OPM.
    • “Overall, the agency is sitting on an inventory of nearly 18,000 cases after it reduced its working caseload to new lows this year. About this time last year, there were 29,000 pending cases.
    • “Still, despite efforts to dispatch focus teams to address backlogs, the agency is failing to hit its target time or inventory goals, leaving retirees to wonder whether their case will be one that ends up sitting in limbo for longer. Ideally, retirement applications are processed in 60 days or fewer.”
  • CMS released its 2022 report on covered entity compliance with the HIPAA electronic transactions.
    • The transaction types experiencing the most violations during the 2020 and 2021 compliance reviews were specific to 835 [the claim transaction], 271 [Health Care Eligibility Response], and 277 [Claim Status Response] transactions. This changed slightly in 2022 as the most common transaction types experiencing violations are now 835, 271, and 834 [EOB] transactions.
    • CMS is sharing updated 2022 violation findings insights to inform and educate the industry, encourage widespread compliance, and assist covered entities with preparing for compliance reviews.
  • The Society for Human Resource Management relates,
    • The U.S. Equal Employment Opportunity Commission (EEOC) has released an updated deadline for employers to submit their demographic data. The EEO-1 Component 1 data collection for 2022 will start on Oct. 31, and the deadline for employers to file their EEO-1 reports is Dec. 5.
    • All private employers that have at least 100 employees are required to file the EEO-1 form annually, detailing the racial, ethnic and gender composition of their workforce by specific job categories.
    • Likewise, federal government contractors and first-tier subcontractors with 50 or more employees and at least $50,000 in contracts must file EEO-1 reports. State and local governments and public school systems are exempt.
  • KFF reports
    • “Over the past two years, the federal government has provided about $1 billion from the American Rescue Plan and Bipartisan Safer Communities Acts to launch the number, designed as an alternative to 911 for those experiencing a mental health crisis. After that infusion runs out, it’s up to states to foot the bill for their call centers.
    • “We don’t know what Congress will allocate in the future,” said Danielle Bennett, a spokesperson for the federal Substance Abuse and Mental Health Services Administration, which oversees 988. “But the hope is that there will be continued strong bipartisan support for funding 988 at the level it needs to be funded at and that states will also create funding mechanisms that make sense for their states.”
    • “Only eight states have enacted legislation to sustain 988 through phone fees, according to the National Alliance on Mental Illness, which is tracking state funding for the system. Others have budgeted short-term funding. But many predominantly rural states, where mental health services are in short supply and suicide rates are often higher than in more urban states, have not made long-term plans to provide support.”
  • MedPage reports,
    • When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, it left oral phenylephrine (with brands including Sudafed PE and Suphedrine PE) as the only nasal decongestant available without pharmacy assistance. But there’s one big problem: phenylephrine doesn’t work, the FDA has finally determined.
    • FDA reviewers released the results of their long-running review of the evidence this week as background for a meeting of the Nonprescription Drugs Advisory Committee to be held on September 11 and 12.
    • The article explains the conundrum this finding creates for the FDA.

From the public health front,

  • MedPage reports that “the global incidence of early-onset cancer has increased by 79% over the past three decades, researchers reported.
    • “In a comment posted on Science Media Centre, Dorothy C. Bennett, MA, PhD, of St. George’s, University of London, cautioned that the increase in new cases of early-onset cancer is based on absolute numbers, rather than age-standardized rates.
    • “The world human population increased by 46% between 1990 and 2019, which explains part of the increase in total case numbers,” she said, adding that the increase in numbers of cancer deaths in this age group (28%) was notably lower than the number of new diagnoses, “which is below the increases in total population and case numbers, indicating a fall in the average cancer death rate in this group.”
  • Per the American Heart Association,
    • Obesity-related cardiovascular disease deaths tripled between 1999 and 2020 in the U.S.
    • Such deaths were higher among Black individuals (highest among Black women) compared with any other racial group, followed by American Indian/Alaska Native people.
    • Black adults who lived in urban communities experienced more obesity-related cardiovascular disease deaths than those living in rural areas, whereas the reverse was true for all other racial groups.
  • McKinsey Health offers a podcast about getting to the bottom of the teen health crisis.

From the U.S. healthcare business front,

  • Fierce Healthcare notes, “Employers’ health benefits costs are set to rise 5.4% next year, but this spike isn’t as high as may have been feared given inflationary pressures in the broader economy, according to a new analysis from Mercer.”
  • STAT News interviews “Amazon’s chief medical officers on where the company’s health care bets are headed next.”
  • Healthcare Dive informs us,
    • “Telehealth sessions comprised 5.4% of claim lines in June, the same amount as the prior month, according to Fair Health’s Monthly Telehealth Regional Tracker.
    • “Mental health conditions continued to top the list of Fair Health’s five most common telehealth diagnoses for June. The median allowed amount billed for a one-hour psychotherapy visit was $103.
    • “But Fair Health’s tracker showed regional variations. Although telehealth use decreased overall by 2.4% in the Midwest, asynchronous telehealth claim lines for mental health conditions more than doubled in the region from 15.9% in May to 36% in June. In asynchronous telehealth, providers collect data or medical images for review, instead of meeting with a patient in real time.” 
  • Per Health Affairs,
    • “Intensive care units (ICUs) are increasingly used for hospital care, yet out-of-pocket spending for ICU hospitalizations remains poorly understood, particularly among the nearly half of the US population with commercial health insurance. Using 2008–19 MarketScan data, we compared 1,441,810 hospitalizations involving ICU services with 13,011,208 hospitalizations that did not involve ICU services.
    • “Average cost sharing, adjusted for patient and admission factors, increased from $1,137 per hospitalization in 2008 to $1,539 in 2019, or a 34 percent increase. This was driven by increasing deductibles, which rose by 163 percent.
    • “Across twenty clinical conditions whose hospitalizations commonly occurred in both ICU and non-ICU settings, ICU admission was associated with $155 higher cost-sharing (13.0 percent higher) relative to cost sharing in non-ICU hospitalizations.
    • “Patients with high-deductible plans faced the highest cost-sharing relative to those with other plan types.
    • “Patients who received out-of-network hospital care encountered higher cost-sharing relative to those admitted to in-network hospitals with in-network clinicians.”