Weekend update

OPM

Weekend update

David Ermer–Congress, Medical / Rx research, OPM, U.S. Healthcare–

Happy Easter! Yesterday, the FEHBlog read about a 1964 Italian film called the Gospel According to St. Matthew. The FEHBlog found and watched the film on the Concierge Channel following two UConn basketball victories. The film is available on YouTube.

From Washington, DC,

  • Congress continues it break from Capitol Hill this week.
  • Last Wednesday, OPM’s PBM pharmacy benefits panel at the FEHB carrier conference featured a New Jersey attorney who was warning that plan sponsors can be held liable for PBM contracting mismanagement, pointing to the Lewandowski v. Johnson & Johnson case.   Here is a link to the defense counsel’s letter to the federal district court in New Jersey describing Johnson & Johnson’s strong (in my opinion) defenses in that ERISA case and a link to a related 1st Circuit ERISA opinion from earlier this year.  In any case, as the FEHBlog pointed out at the conference, FEHB plans are exempt from ERISA as governmental plans.

From the public health and medical research front,

  • The Washington Post reports,
    • “More than three-quarters of sudden infant deaths involved multiple unsafe sleep practices, including co-sleeping, a recent analysis suggests.
    • “A study published in the journal Pediatrics looked at 7,595 sudden infant death cases in a Centers for Disease Control and Prevention registry between 2011 and 2020. The majority of deaths occurred in babies less than 3 months old.
    • “The statistics revealed that 59.5 percent of the infants who died suddenly were sharing a sleep surface at the time of death, and 75.9 percent were in an adult bed when they died. Though some demographic factors such as sex and length of gestation were not clinically significant, the researchers found that the babies sharing a sleep surface were more likely to be Black and publicly insured than those who didn’t share sleep surfaces. Soft bedding was common among all the infants who died, and 76 percent of the cases involved multiple unsafe practices.
    • “The analysis mirrors known risk factors for sudden infant death. Current recommendations direct parents and other caretakers to provide infants with firm, flat, level sleep surfaces that contain nothing but a fitted sheet. Though room sharing reduces the risk of sudden infant death, CDC officials discourage parents from sharing a sleep surface with their child.”
  • Fortune Well tells us,
    • “Oral health isn’t one of the most exciting self-care practices—but it’s an important one. What’s going on in your mouth is a strong indicator of your overall well-being. So, brushing and flossing every day isn’t just a bid for your dentist’s approval, it’s a win for your overall health. 
    • “Experts say there’s one more way to look after your teeth and gums: rinsing your mouth with water after you eat. * * *
    • “Every time you eat, your saliva breaks food down for digestion which will create an acid byproduct,” explains Lilya Horowitz, DDS, of Domino Dental in Brooklyn, New York. “This leads to more biofilm and plaque buildup, so rinsing with a neutral or basic water can help lower the pH in the mouth.” In an acidic environment or an environment below 4.5 pH, the enamel of the teeth will start to break down.”
  • MedPage Today lets us know,
    • Starting medication for alcohol use disorder (MAUD) at hospital discharge reduced readmission risk, a cohort study suggested.
    • Of nearly 10,000 alcohol-related hospitalizations of Medicare beneficiaries, only 2% (192) involved initiation of MAUD at the time of discharge, Eden Bernstein, MD, of Massachusetts General Hospital in Boston, and colleagues found.
    • In this small number, MAUD initiation at discharge was linked with a 42% decreased incidence of returning to the hospital within 30 days (incident rate ratio [IRR] 0.58, 95% CI 0.45-0.76, the researchers reported in JAMA Network Open. 
  • MedTech Dive informs us,
    • “Exact Sciences shared early results of a test it is developing with Mayo Clinic to screen for esophageal cancer and its precursors.
    • “The test, called Oncoguard Esophagus, uses an encapsulated sponge device to collect esophageal cells. DNA is extracted from the cells and processed in a PCR assay. The results from the assay are run through an algorithm, which provides a positive or negative result, Paul Limburg, Exact Sciences’ chief medical officer of screening, wrote in an email. 
    • “The test, which is designed to be less invasive than an endoscopy, detected esophageal adenocarcinoma and Barrett’s esophagus, a known precursor to the cancer, according to results published in Clinical Gastroenterology and Hepatology. The National Institutes of Health and Exact Sciences funded the study.”
  • Per Medscape,
    • “Artificial intelligence (AI) has identified two plant-based bioactive compounds with potential as glucagon-like-peptide-1 receptor (GLP-1R) agonists for weight loss as possible alternatives to pharmaceutical weight-loss drugs, but with potentially fewer side effects and oral administration.
    • “Using AI, the work aimed to identify novel, natural-derived bioactive compounds that may activate the GLP-1R, which is the site of action of existing weight loss pharmaceutical drugs including semaglutide (Wegovy, Novo Nordisk) and dual agonist tirzepatide (Zepbound, Eli Lilly).
    • “Presenter Elena Murcia, PhD, of the Structural Bioinformatics and High-Performance Computing Research Group & Eating Disorders Research Unit, Catholic University of Murcia, Murcia, Spain, will be sharing her work at the upcoming European Congress on Obesity (ECO 2024) in May.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s Surest is the organization’s fastest growing commercial health plan, boasting no deductibles and a shoppable healthcare experience built around price transparency.
    • “In March, Aon published an analysis of medical and pharmacy spending among Surest members in 2021 and 2022, totaling more than 92,000 and 156,000, respectively. Aon compared the experience of Surest members to that of a control group composed of members from a multi-employer database with matching geography, demographics, and medical and mental health comorbidities during the same time periods.
      • “Surest members had $365 lower total spend per-member per-year in 2021 and $412 lower spend in 2022.
      • “Surest’s total cost of care was 7.5% lower in 2021 and 7.7% lower in 2022.
      • “Results in 2022 were driven by 96.7% lower allowed medical claims and 78.8% lower allowed drug claims.
      • “Key drivers of cost efficiencies in 2022 were 93.1% lower professional spend and 71.5% lower specialty pharmacy spend.”
  • Healthexec and KFF discuss the state of concierge medicine.
    • “Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.
    • “It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.”

Thursday Miscellany

David Ermer–CDC, CMS, COVID-19, Medical / Rx research, Medicare, NCQA, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Per HHS press releases, HHS issued the following proposed rules released today (links are to fact sheets);
    • a proposed rule to update Medicare payment policies and rates for the Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) for fiscal year (FY) 2025,
  • and
    • a proposed rule (CMS-1810-P) that would update Medicare hospice payments and the aggregate cap amount for fiscal year (FY) 2025,
  • and
    • “a proposed rule that would update Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility Prospective Payment System (SNF PPS) for fiscal year (FY) 2025.” 
  • Here is the fact sheet for the Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) final rules regarding short-term, limited-duration insurance (STLDI) and independent, noncoordinated excepted benefits coverage under the Affordable Care Act released today. 
  • Per the American Medical Association News,
    • The Office of Management and Budget March 28 released its final updated standards for Federal agencies on maintaining, collecting and presenting data on race and ethnicity. Last updated in 1997, the revised Statistical Policy Directive Number 15 is the product of an OMB Interagency Technical Working Group on Race and Ethnicity Standards. While SPD 15 does not mandate race and ethnicity data collection by federal agencies, it requires federal agencies to adhere to standardized data definitions, collection and presentation practices wherever they do collect or use such data. Among other changes, the revised SPD 15 requires that race and ethnicity be collected using a single question with multiple responses, superseding OMB’s previous requirement to collect Hispanic ethnicity as a separate question. In addition, SPD 15 adds a category for Middle Eastern or North African (MENA) as a minimum reporting category and requires federal agencies to collect more detailed information on race and ethnicity beyond the seven minimum reporting categories. However, agencies may request and receive exemptions from OMB in instances where the potential benefit of more detailed data do not justify the additional burden to the agency or the public, or where the collection of more detailed data would threaten privacy or confidentiality. 
    • The updated SPD 15 is effective immediately. However, federal agencies have until March 28, 2029, to bring existing data collection and reporting activities into compliance with the updated SPD 15 and must submit action plans to OMB on how they will comply with the requirements by Sep. 28, 2025.
  • OPM made a passing reference to this guidance today on the second day 0f the OPM carrier conference.
  • The Labor Department’s Office of Federal Contractor Compliance Programs issued “Updated Annual Hiring Benchmark and New Benchmark Resources” for the veteran’s affirmative action in employment law that applies to FEHB carriers.

From the public health and medical research front,

  • Mercer discusses weight management in the era of GLP-1 drugs.
  • The NIH Director, in her blog, points out that an “Immune Checkpoint Discovery Has Implications for Treating Cancer and Autoimmune Diseases.”
  • The Washington Post reports,
    • “Diabetes, air pollution and alcohol consumption could be the biggest risk factors for dementia, study has found.
    • “Researchers compared modifiable risk factors for dementia — which is characterized by the impairment of memory, thinking and reasoning — and studied how these factors appear to affect certain brain regions that are already particularly vulnerable to Alzheimer’s disease and schizophrenia.
    • “The research, based on brain scans of nearly 40,000 adults, between ages 44 and 82, in Britain was published Wednesday in Nature Communications.”
  • Health Day informs us,
    • “Some folks struggling with obesity appear to be hampered by their own genes when it comes to working off those extra pounds, a new study finds.
    • “People with a higher genetic risk of obesity have to exercise more to avoid becoming unhealthily heavy, researchers discovered.
    • “Genetic background contributes to the amount of physical activity needed to mitigate obesity. The higher the genetic risk, the more steps needed per day,” said senior researcher Douglas Ruderfer, director of the Center for Digital Genomic Medicine at Vanderbilt University Medical Center in Nashville, Tenn.”
  • MedPage Today lets us know,
    • “For adults who are immunocompromised, the updated 2023-2024 COVID-19 vaccine reduced risk of hospitalization compared with not getting the shot, according to CDC data.
    • “Vaccine effectiveness against hospitalization was 38% in the first 7 to 59 days after receipt of the updated monovalent XBB.1.5 COVID vaccine, and 34% in the 60 to 119 days after receipt, reported Ruth Link-Gelles, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.
    • “However, despite the positive effect, only 18% of people in this high-risk population had received the updated COVID vaccine, “representing a missed opportunity to prevent severe COVID-19,” the authors wrote.”
  • Medscape notes,
    • “Starting an exercise regimen with others can be a powerful fitness motivator, and new research spotlights the strategy’s particular importance for older adults.
    • “In a randomized clinical trial in JAMA Network Open, older adults who talked with peers about their exercise program were able to increase and sustain physical activity levels much better than those who focused on self-motivation and setting fitness goals.
    • “Such self-focused — or “intrapersonal” — strategies tend to be more common in health and fitness than interactive, or “interpersonal,” ones, the study authors noted. Yet, research on their effectiveness is limited. Historically, intrapersonal strategies have been studied as part of a bundle of behavioral change strategies — a common limitation in research — making it difficult to discern their individual value.
    • “We’re not saying that intrapersonal strategies should not be used,” said study author Siobhan McMahon, PhD, associate professor and codirector of the Center on Aging Science and Care at the University of Minnesota, in Minneapolis, Minnesota, “but this study shows that interpersonal strategies are really important.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The first major U.S. health insurers have agreed to start paying for the popular anti-obesity drug Wegovy for certain people on Medicare with heart-related conditions.
    • “CVS Health,  Elevance Health, and Kaiser Permanente said they would cover 
    • “Novo Nordisk’s Wegovy for the use of reducing the risk of heart attacks and strokes in people who have cardiovascular disease, meet body-weight criteria and are covered by a Medicare drug-benefit plan.
    • “Elevance, which operates many Blue Cross and Blue Shield health plans, also said it would extend coverage to people insured by a commercial plan.
    • “Some of the plans, including Kaiser Permanente’s, are making the coverage change effective immediately, while others, including those served by Elevance, will do so in the coming weeks.”
  • Axios informs us,
    • “The federal process for resolving billing disputes for out-of-network care has to date yielded payouts well above what Medicare and most in-network private insurers would pay providers, according to a new Brookings Institution analysis provided first to Axios. 
    • “Why it matters: That could lead to downstream effects like higher premiums — quite the opposite of what Congress intended when it passed a law banning surprise medical bills in 2020.
    • “What they found: Brookings analyzed Centers for Medicare and Medicaid Services data on arbitration decisions to settle disputed claims during the first half of 2023. 
    • “Researchers specifically focused on emergency care, imaging and neonatal and pediatric critical care.
    • “Across the three categories, median payouts were at least 3.7 times what Medicare would pay, Brookings found. 
    • “For emergency care and imaging, the median decision was at least 50% higher than the most generous payments commercial plans historically made, on average, for in-network care. 
    • “Similar estimates weren’t available for neonatal and pediatric critical care.
    • “The analysis concludes that there is a “realistic possibility” that the law will wind up raising in-network prices and, in turn, premiums.
    • “That’s the opposite of what the Congressional Budget Office predicted would happen.”
  • Interesting study but its conclusion is undercut by the fact that many providers accept the qualifying payment amount the the plans initially pay under the No Surprises Act.
  • Per Healthcare Dive,
    • Walgreens reported an almost $6 billion net loss in the second quarter, according to financial results released Thursday. Nearly all of that sum was attributable to the declining value of a single play: VillageMD, the primary care chain into which Walgreens has poured billions of dollars, but which has generated disappointing returns to date.
    • Walgreens was forced to write down VillageMD’s value after its financial team flagged a mismatch in the subsidiary’s value as recorded in its balance sheet and its value in the market, CFO Manmohan Mahajan told investors on a Thursday morning call. That discrepancy led Walgrens to record a $5.8 billion goodwill impairment charge.
  • and
    • “UCI Health has completed its $975 million purchase of four Southern California hospitals from Tenet Healthcare, the academic health system said Tuesday. Tenet announced the sale in February as part of an ongoing effort to fund debt repayment.”
  • and
    • “Ascension has signed a definitive agreement to divest three hospitals and an ambulatory surgical center in northern Michigan to MyMichigan Health, the health systems said Tuesday. 
    • “The deal includes Ascension St. Mary’s in Saginaw, Ascension St. Joseph in Tawas City, Ascension St. Mary’s in Standish and ambulatory surgery center and emergency department Ascension St. Mary’s Towne Center in Saginaw. Related care sites and physician practices are also included. 
    • “Ascension has recently sold other hospitals as the nonprofit expands its ambulatory and telehealth footprint.”

Midweek Update

David Ermer–Congress, Federal employment benefits, Medicare, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • From a Senate press release,
    • Today, Senator Rick Scott and Senator Tom Carper announced the bipartisan FEHB Protection Act to stop fraud within the Federal Employee Health Benefits (FEHB) program, the largest employer-sponsored health insurance program in the country which covers eight million federal employees, retirees and family members. The FEHB Protection Act will codify Government Accountability Office (GAO) and Office of Inspector General (OIG) recommendations to require the Office of Personnel Management (OPM) to verify eligibility before adding family members, additionally, the bill requires an audit and removal of those ineligible for the program to ensure taxpayer dollars are used wisely and program benefits are protected for truly eligible individuals. This legislation follows a study conducted by the GAO at Senator Scott’s request, which revealed that OPM’s mismanagement of the FEHB program allowed ineligible individuals to obtain employer-sponsored health coverage at the hefty price tag of approximately $1 billion in taxpayer dollars every year.
    • The FEHBlog doubts the accuracy of GAO’s projection because half of the FEHB enrollment is self only and FEHB family sizes are notoriously small. In any case, this approach will not solve the problem because OPM reports enrollment actions and premiums separately even though using the HIPAA 820 electronic enrollment roster transaction would allow carriers to confirm receipt of premium for each enrollee systematically.
  • From the American Hospital Association News,
    • The Centers for Medicare & Medicaid Services March 27 finalized a rule proposed in 2022 to standardize Medicaid and CHIP enrollment and renewal processes and make it easier for eligible children and adults to stay covered. According to CMS, the final rule eliminates CHIP waiting periods, annual and lifetime coverage limits and the practice of locking children out of coverage if a family is unable to pay premiums; improves the transfer of children from Medicaid to CHIP when a family’s income rises; gives individuals at least 15 days to provide additional information when applying for the first time and 30 days to return documentation when renewing coverage; prohibits conducting renewals more often than every 12 months; and prohibits in-person interviews for older adults and those with disabilities. The rule takes effect 60 days after publication in the April 2 Federal Register.
  • and
    • The Centers for Medicare & Medicaid Services March 27 released the fiscal year 2025 proposed rule for inpatient rehabilitation facilities, which would update IRF payments by an estimated 2.8% overall (or $280 million) in FY 2025. This includes a 3.2% market basket update, which is reduced by a 0.4% productivity adjustment. IRF payments would be further decreased by an estimated $25 million due to the proposed update for outlier payments.
  • and
    • The Department of Health and Human Services’ Administration for Strategic Preparedness and Response and Centers for Medicare & Medicaid Services this week released a guide to health plan resources for health care providers impacted by the Change Healthcare cyberattack, including health plan contact information, noting in an accompanying letter that many providers continue to face significant disruptions as a result of the cyberattack or difficulty getting information from health plans about prospective payments and other flexibilities. The letter also encourages providers to review HHS’ voluntary cybersecurity performance goals.
  • It is worth adding that the United Healthcare Group updated its Change Healthcare Cyberattack response page today.

From the public health front,

  • The Washington Post reports,
    • “On Monday, government leaders in Puerto Rico declared a dengue epidemic after a spike in cases of the mosquito-borne disease hit the island.
    • “From the start of the year through March 10, there were 549 cases, including 341 hospitalizations and 29 severe cases, according to the most recent data provide by the Puerto Rico Department of Health. Cases are concentrated in cities including San Juan, Bayamon, Guaynabo and Carolina.
    • “Between 2010 and 2020, more than 30,000 dengue cases were reported from four U.S. territories, with Puerto Rico reporting the most. In 2012, Puerto Rico reported 199 deaths, which was the last time the commonwealth declared a dengue epidemic.”
  • The Wall Street Journal ponders,
    • “How closely should you be tracking your blood-sugar levels? * * *
    • “Soon, people without diabetes will be able to buy a monitor without needing to cajole a doctor into prescribing them one. The Food and Drug Administration recently approved the over-the-counter sale of a continuous glucose monitor, also known as a CGM. The devices allow people to continuously monitor their blood sugar levels.
    • “People who obsess over their health data or have an unhealthy relationship with food should avoid CGMs, most doctors say. Users might misinterpret normal glucose fluctuations as unhealthy, causing anxiety and prompting them to restrict certain foods. It isn’t clear that healthy patients would benefit from using a CGM over the long term.
    • “However, people at higher risk of developing diabetes, and those who are interested in working with their doctors to make lifestyle changes, might find it helpful. The technology could spot early signs of insulin resistance, possibly helping otherwise healthy people avoid Type 2 diabetes, some doctors say. 
    • “If we identify these patients sooner, we can suggest lifestyle modifications as well as maybe the initiation of weight-loss medications,” says Dr. Brenda Dorcely, an endocrinologist at NYU Langone Health.” 

Tidbits from the OPM FEHB carrier conference

  • The FEHBlog attended OPM’s virtual FEHB carrier conference today. Here are some tidbits.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Beleaguered health system Steward Health Care has agreed to sell its physician network, Stewardship Health, to healthcare behemoth UnitedHealth Group for an undisclosed sum, according to documents filed with Massachusetts regulators on Tuesday.
    • “Under the deal, UnitedHealth’s care delivery subsidiary Optum Care would acquire Steward’s nine-state footprint of primary care providers and clinicians. It will also acquire all of Stewardship’s stock. 
    • “The Health Policy Commission, an independent Massachusetts agency tasked with monitoring state healthcare spending, will have 30 days to assess the potential impact of a Optum-Steward deal on healthcare costs, quality and access, HPC director David Seltz said in a statement. Already, some legislators and health M&A experts are urging a close review of the transaction, citing antitrust concerns.”
  • Per MedTech Dive,
    • “Johnson & Johnson is in talks to acquire Shockwave Medical, The Wall Street Journal reported Tuesday, citing people familiar with the matter.
    • “A deal could come in the next few weeks. However, the report noted that talks could fall through, or another company could pick up Shockwave. J&J and Shockwave both told MedTech Dive they do not comment on market rumors or speculation.
    • “Shockwave makes medical devices that break up calcium deposits in coronary arteries using sound pressure waves, a technique called intravascular lithotripsy (IVL).”
  • Beckers Payer Issues offers an interview with Aetna’s chief medical officer about managed care lessons from Medicaid to Medicare.

Midweek Update

David Ermer–CMS, Congress, COVID-19, Cybersecurity, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., and his top lieutenants on Wednesday morning moved to quell reservations among their conference about the emerging $1.2 trillion-plus final spending package headed for a vote likely on Friday, while their Democratic counterparts did likewise in a separate meeting.
    • “Appropriators were scrambling under a tight timeline to finish drafting the measure, which is taking longer than expected due to a last-minute decision to write a full-year Homeland Security bill. But Johnson told reporters after a GOP conference meeting that text is expected as soon as Wednesday afternoon.
    • “Other sources expected the bill drop to slip to Thursday, with the standard “reading out” of the DHS title, to catch any errors before posting, not even expected to begin until later Wednesday. But no matter: Lawmakers said they expect the chamber to vote as soon as Friday, regardless of a 72-hour review rule. * * *
    • “Final passage wouldn’t come until this weekend at the earliest, and senators are working to accommodate Sen. Susan Collins, R-Maine, who has never missed a vote but will be attending her mother’s funeral on Saturday. That could push votes off until Sunday or Monday, though few are worried at this point about the effects of such a brief funding lapse. 
    • “I don’t think we’ll do a [continuing resolution],” Johnson said.”
  • The American Hospital Association (AHA) News informs us,
    • “The House Energy and Commerce Committee March 20 unanimously passed AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.”
  • and
    • “Congress should address any statutory constraints that prevent the Centers for Medicare & Medicaid Services and Department of Health and Human Services from adequately helping hospitals and other health care providers impacted by the Change Healthcare cyberattack, AHA said a letter submitted to the House Ways and Means Committee for a hearing March 20 with HHS Secretary Xavier Becerra on fiscal year 2025 funding for HHS.”
  • Govexec tells us,
    • “The top senator with direct oversight of the U.S. Postal Service is calling on its leadership to pause its overhaul of the agency’s mailing network due to potential impacts they are having on delivery, rejecting USPS assertions that is has provided transparency. 
    • “USPS should not continue its nationwide operational reforms until it can prove the changes will not negatively impact mail service, Sen. Gary Peters, D-Mich., who chairs the Senate Homeland Security and Governmental Affairs Committee, said in a letter to Postmaster General Louis DeJoy. Agency leadership said in response to the letter it has offered volumes of documents and many staff-level briefings to Congress, though Peters said USPS ignored many of his requests for additional information on its efforts and left Congress uncertain about the fallout that could befall postal customers.”
  • On March 18, 2024, the Office of Management and Budget’s Office of Information and Regulatory Affairs received for final regulatory review an OPM proposed rule with additional requirements and clarifications for the Postal Service Health Benefits Program (RIN 3206-AO59).
  • The AHA News tells us,
    • “U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced March 19, citing potential quality and performance issues. The recommendations do not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said. The agency advises health care providers to confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.”
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa M. Gomez, posted on her blog about “Health and Money Smarts for Women.”
  • Fierce Healthcare lets us know,
    • “The Employee Retirement Income Security Act, or ERISA, is turning 50 this year and lawmakers are curious to hear about how the law could be updated to increase coverage affordability and care access.
    • “Payers and providers, it turns out, have very different ideas on where Congress should focus its efforts.
    • “In response to the House Committee on Education and the Workforce’s January request for information, lobbying groups representing both sides of the industry weighed in on the act that outlines federal guidelines for employee benefit plans, including employer-sponsored group health plans.”
    • The article delves into these comments.
  • Newfront offers insights about 2024 RxDC reporting considerations. The reports are due June 1, 2025.
  • The Congressional Budget Office released a presentation about “The Federal Perspective on Coverage of medications to treat obesity. Assuming Congress allows Medicare to cover anti-obesity medications (AOM),
  • “The future price trajectory of AOMs is highly uncertain.
    • “CBO expects semaglutide to be selected for price negotiation by the Secretary of Health and Human Services within the next few years, which would lower its price (and potentially the prices of other drugs in the AOM class).
    • “CBO expects generic competition for semaglutide and tirzepatide to start in earnest in the second decade of a policy allowing Medicare Part D to cover AOMs.
    • “New AOMs are expected to become available. The new drugs might be more effective, have fewer side effects, or be taken less frequently or more easily than current medications. Those improvements could translate to higher prices, on average, even if prices decline for drugs that exist today.”
  • See also the Beckers Hospital Review article below on the next generation of AMOs.
  • Healthcare Dive tells us,
    • “The Medicare Advisory Payment Commission, which advises Congress on Medicare policy, is recommending boosting hospital payment rates by 1.5% in 2025 and base physician payment rates by 1.3% above current law, according to its annual report released Friday. 
    • “MedPAC suggested tying the rate of physician payment increasesmoving forward to the Medicare Economic Index, an annual measure of practice cost inflation. MedPAC suggested payments increase “by the amount specified in current law plus 50% of the projected increase in the MEI.”
    • “Provider groups, including the Medical Group Management Association and American Medical Association, have said the proposed payment increases are inadequate.”

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two-thirds of young children in Chicago could be exposed to lead-contaminated water, according to an estimate by the Johns Hopkins Bloomberg School of Public Health and the Stanford University School of Medicine.
    • “The research, published Monday in the journal JAMA Pediatrics, estimated that 68 percent of children under the age of 6 in Chicago are exposed to lead-contaminated drinking water. Of that group, 19 percent primarily use unfiltered tap water, which was associated with a greater increase in blood lead levels.
    • “The extent of lead contamination of tap water in Chicago is disheartening — it’s not something we should be seeing in 2024,” lead author Benjamin Huynh, assistant professor of environmental health and engineering at the Johns Hopkins Bloomberg School of Public Health, said in a news release.”
  • The Wall Street Journal relates,
    • “Debi Lucas had a tremor in her arm. Her feet froze when she tried to walk and she fell into her coffee table, busting her lip. 
    • “She went to a neurologist who thought she had Parkinson’s disease. Doctors normally diagnose the neurodegenerative condition by symptoms. Lucas, 59, had them. 
    • “But the neurologist, Dr. Jason Crowell, couldn’t be sure. The symptoms might be related to a traumatic brain injury Lucas suffered in a car accident decades earlier, he thought. Or they might be from her medications. 
    • “To find an answer, Crowell turned to a new test: a skin biopsy that can detect an abnormal protein people with Parkinson’s have inside their nerves. He took samples of skin near her ankle, knee and shoulder and sent them to a lab. 
    • “The results confirmed that Lucas has Parkinson’s. The diagnosis was scary, but Lucas finally knew what was causing her symptoms. “I was glad to have a name on it,” she said. 
    • “The test sped her diagnosis, said Crowell, a movement-disorders neurologist at the Norton Neuroscience Institute in Louisville, Ky. “It just gives me more confidence,” he said. 
    • “The skin test is an important part of progress researchers are making against Parkinson’s, the second-most common age-related neurodegenerative condition, which is on the rise and a major driver of disability, dementia and death. The test Lucas received, made by CND Life Sciences, a medical technology company in Scottsdale, Ariz., is one of a few in use or development to allow doctors to diagnose Parkinson’s based on biology rather than symptoms that can take years to appear“.
  • Medscape explains “why a new lung cancer treatment is so promising.”
  • MedPage Today notes,
    • “The FDA has approved aprocitentan (Tryvio), making it the first endothelin receptor antagonist for the treatment of high blood pressure (BP), Idorsia Pharmaceuticals announced on Wednesday.
    • “The once-daily oral medication is indicated in combination with other antihypertensive drugs to lower BP in adult patients who do not have their BP controlled with other therapies.
    • “It is believed that some people may respond better to the drug’s novel mechanism, as aprocitentan is a dual endothelin receptor antagonist that works differently than conventional diuretics, renin-angiotensin-aldosterone system antagonists, calcium channel blockers, and beta-blockers used to lower BP.”
  • Beckers Hospital Review considers the three generations of weight loss drugs.
    • “Anita Courcoulas, MD, defines GLP-1s as “generation one;” dual GLP-1 and GIPs as the second; and a triple threat of GLP-1, GIP and GCGRs as the third generation of weight loss drugs. 
    • “Dr. Courcoulas is chief of Pittsburgh-based UPMC’s minimally invasive bariatric and general surgery program. She told Becker’s the next class of anti-obesity medications are finally reaching weight loss outcomes seen from gastric sleeve and bypass procedures, the two most common surgeries for trimming pounds. * * *
    • “Dr. Courcoulas said the biggest unknown is long-term durability of these medications, a concern other bariatric experts have raised. 
    • “She expects GLP-GIP-GCGR medications to gain approval and enter the U.S. market next year. 
    • “I think it’s very exciting to realize there are medications that are under investigation now that could come to market that could have even better weight loss results than the two drug [classes] we’re seeing now,” Dr. Courcoulas said.”
  • The National Institutes of Health announced,
    • “SARS-CoV-2, the virus that causes COVID-19, can damage the heart even without directly infecting the heart tissue, a National Institutes of Health-supported study has found. The research, published in the journal Circulation, specifically looked at damage to the hearts of people with SARS-CoV2-associated acute respiratory distress syndrome (ARDS), a serious lung condition that can be fatal. But researchers said the findings could have relevance to organs beyond the heart and also to viruses other than SARS-CoV-2.
    • “Scientists have long known that COVID-19 increases the risk of heart attack, stroke, and Long COVID, and prior imaging research has shown that over 50% of people who get COVID-19 experience some inflammation or damage to the heart. What scientists did not know is whether the damage occurs because the virus infects the heart tissue itself, or because of systemic inflammation triggered by the body’s well-known immune response to the virus.
    • “This was a critical question and finding the answer opens up a whole new understanding of the link between this serious lung injury and the kind of inflammation that can lead to cardiovascular complications,” said Michelle Olive, Ph.D., associate director of the Basic and Early Translational Research Program at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH. “The research also suggests that suppressing the inflammation through treatments might help minimize these complications.”
  • and
    • “An investigational gene therapy for a rare neurodegenerative disease that begins in early childhood, known as giant axonal neuropathy (GAN), was well tolerated and showed signs of therapeutic benefit in a clinical trial led by the National Institutes of Health (NIH). Currently, there is no treatment for GAN and the disease is usually fatal by 30 years of age. Fourteen children with GAN, ages 6 to 14 years, were treated with gene transfer therapy at the NIH Clinical Center and then followed for about six years to assess safety. Results of the early-stage clinical trial appear in the New England Journal of Medicine. 
    • “The gene therapy uses a modified virus to deliver functional copies of the defective GAN gene to nerve cells in the body. It is the first time a gene therapy has been administered directly into the spinal fluid, allowing it to target the motor and sensory neurons affected in GAN. At some dose levels, the treatment appeared to slow the rate of motor function decline. The findings also suggest regeneration of sensory nerves may be possible in some patients. The trial results are an early indication that the therapy may have favorable safety and tolerability and could help people with the rapidly progressive disease.
    • “One striking finding in the study was that the sensory nerves, which are affected earliest in GAN, started ‘waking up’ again in some of the patients,” said Carsten G. Bonnemann, M.D., senior author and chief of the Neuromuscular and Neurogenetic Disorders of Childhood Section at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH. “I think it marks the first time it has been shown that a sensory nerve affected in a genetic degenerative disease can actually be rescued with a gene therapy such as this.”
  • Lifesciences Intelligence reports,
    • “Recently, JAMA Network Open published a study analyzing the association between a healthy diet, sleep duration, and type 2 diabetes (T2D) risk. The study data revealed that habitual short sleep duration was linked to an increased probability of T2D by as much as 41%.
    • “Using data on 247,867 individuals from the UK biobank, researchers divided patients into groups based on their sleeping habits. The stratified groups included normal (7–8 hours per night), mildly short (6 hours per night), moderately short (5 hours per night), and extremely short (3–4 hours per night).
    • “Across all study participants, only 3.2% were diagnosed with T2D; however, the adjusted hazard ratios revealed that the prevalence of T2D was higher among shorter sleep groups. More specifically, the increased probability of T2D was identified in those who slept 5 hours or less per night. Those in the moderate short sleep group were 16% more likely to have a T2D diagnosis. Additionally, those in the extremely short sleep group had a 41% greater likelihood of being diagnosed with T2D.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease at a record-setting wholesale price of $4.25 million. 
    • “The therapy, Lenmeldy, won Food and Drug Administration approval on Monday to treat patients with early-onset metachromatic leukodystrophy, or MLD. The disease, which most often attacks infants between six months and two years of age, robs patients of the ability to walk, talk and function in the world, killing most of its earliest victims within five years of onset.
    • “Lenmeldy’s price tag will leapfrog those of the two most expensive gene therapies available in the U.S. Sarepta Therapeutics sells its Elevidys treatment for Duchenne muscular dystrophy for $3.2 million, while CSL and UniQure’s hemophilia treatment Hemgenix costs $3.5 million.”
  • MedPage Today lets us know,
    • “Despite being a growing percentage of the physician workforce, women physicians continued to be paid less than their male colleagues, a strong body of evidence shows.
    • “While the gender pay gap decreased by 2% from 2021 to 2022 — from 28% to 26% — the gap was still significant, according to online networking service Doximity’s 2023 physician compensation reportopens in a new tab or window.
    • “Women doctors in 2022 earned nearly $110,000 less per year than men physicians, on average, after adjusting for specialty, location, and years of experience. Data from individual states have backed up this figure, too. For instance, in 2022, the Maryland State Medical Society conducted a survey and found that women doctors in Maryland are paid about $100,000 less annually than men.”
  • Beckers Hospital Review lists ten common issues in pharmacies.
  • United Healthcare updated its Change Healthcare cyberattack response website today.
  • HR Daily Advisor explains how companies are exploring the limitations of employee assistance plans amid the country’s mental health crisis.
  • Forbes reports,
    • “Medical diagnosis and procedure codes are so numerous and varied that Debbie Beall, manager of coding at Houston Methodist in Texas, needs a 49-person team to translate the medical notes written by the system’s 1,600 clinicians into the codes needed to bill insurers.
    • “There is a medical code for every imaginable scenario – from “burn due to water-skis on fire” to “spacecraft collision injuring occupant” — and their specificity determines how much the insurance companies pay. Each team member processes anywhere from 70 to 250 claims per day, depending on the complexity, she said. That’s why Beall is so excited about the possibility of using artificial intelligence to speed up the job.
    • “There’s no way I’m ever going to replace coders completely with an AI system,” Beall told Forbes. But for run-of-the-mill procedures performed multiple times a day in a hospital, like X-rays and EKGs? “Yes, an AI engine can do that.”
    • “Beall was one of the first dozen or so people to test a prototype of an AI-powered medical coding tool from electronic health records giant Epic Systems, which had $4.6 billion in revenue in 2022. Based on GPT-4, the large language model that powers the viral chatbot ChatGPT, Epic’s coding assistant prototype ingests and summarizes clinician notes and then tees up the “most likely” diagnosis codes and procedures codes, along with suggestions of “other potential codes,” according to mock ups viewed by Forbes that did not include real patient information. * * *
    • “While Epic has so far focused on using generative AI in back office functions, it has also been working on a patient-facing application that wouldn’t require human review. Krause told Forbes a tool that would help explain the patient’s bill, including their deductible and outstanding balance, could be rolled out by November. “We feel like that’s a fairly benign place to start. It’s not about healthcare at that point, but it’s really about their billing,” he said. “That’s not going to harm a patient in any way.”

   

Midweek Update

David Ermer–CMS, Cybersecurity, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Federal News Network builds on OPM’s March 12 press release about the Postal Service Health Benefits Program launch in January 2025.
  • STAT News calls attention to healthcare points that you might have missed in the President’s FY 2025 budget. For example,
    • “The budget proposes for the first time a change to the law that would let pharmacists fill prescriptions for brand-name biologics with biosimilars without doctor permission. The measure is part of the administration’s plan to lower drug costs. * * *
    • “Besides budget boosts for behavioral health services, research, and the 988 crisis hotline, the administration is asking Congress for legislative changes to make mental health care more accessible. Those include eliminating Medicare’s 190-day lifetime limit on psychiatric services in hospitals, which it estimates would cost the program $2.9 billion over 10 years. * * *
    • “Medicare would also have to cover three behavioral health visits without cost-sharing, a move that could cost $1.5 billion over a decade. Biden wants to extend this requirement to private insurers as well, at an estimated cost of $428 million over that time.”
  • HealthDay informs us,
    • The White House on Wednesday launched a nationwide call for more training and better access to the lifesaving opioid overdose drug naloxone.
    • Called the Challenge to Save Lives from Overdose, the initiative urges organizations and businesses to commit to train employees on how to use opioid overdose medications, to keep naloxone in emergency kits and to distribute the drug to employees and customers so they might save a life at home, work or in their communities.
    • “Today, we’re calling on organizations and businesses — big and small, public and private — across the country to help ensure all communities are ready to use this lifesaving tool to reduce opioid deaths,” the White House said in a fact sheet announcing the new initiative. “As the drug supply has gotten more dangerous and lethal, we’re asking allies to join us because we all must do our part to keep communities safe.”
  • The CDC is offering free webinars on the RxDC process on March 27 and April 3.

From the Change Healthcare situation front,

  • United Healthcare updated its Change Healthcare situation response website this afternoon.
  • The HHS Office for Civil Rights, which enforces the HIPAA Privacy and Security Rule, issued a Dear Colleague letter about the Change Healthcare situation and announced opening an investigation of UHC about cyberattack and its fallout.
  • The Congressional Research Service posted an insight report titled “The Change Healthcare Cyberattack and Response Considerations for Policymakers.’
  • The American Medical Association explained how providers can navigate the Change Healthcare situation.

From the public health and medical research front,

  • The New York Times reports,
    • “Early detection of colon cancer can prevent a majority of deaths from this disease, possibly as much as 73 percent of them. But just 50 to 75 percent of middle-aged and older adults who should be screened regularly are being tested.
    • “One reason, doctors say, is that the screening methods put many people off.
    • “There are two options for people of average risk: a colonoscopy every 10 years or a fecal test every one to three years, depending on the type of test.
    • “Or, as Dr. Folasade P. May, a gastroenterologist at UCLA Health puts it, “either you take this horrible laxative and then a doctor puts an instrument up your behind, or you have to manipulate your own poop.”
    • “But something much simpler is on the horizon: a blood test. Gastroenterologists say such tests could become part of the routine blood work that doctors order when, for example, a person comes in for an annual physical exam. * * *
    • “A study published on Wednesday in The New England Journal of Medicine found that a blood test searching for such [colon cancer] DNA called Shield and made by the company Guardant Health detected 87 percent of cancers that were at an early and curable stage. The false positive rate was 10 percent.
    • “But there is a caveat to the blood test: While it detects cancers, it misses most large polyps, finding just 13 percent of them. In contrast, the fecal test detects 43 percent and a colonoscopy finds 94 percent, Dr. Carethers said.
    • “While polyps are usually harmless, a few can turn into cancers, so doctors want to find all of them and remove them to prevent cancers from forming.”
  • The Department of Health and Human Services posted a fact sheet on in vitro fertilization across our country.
  • BioPharma Dive tells us,
    • “Merck on Wednesday announced plans to start clinical trials testing a newer version of its vaccine for human papillomavirus, or HPV, as well as a different regimen of the shot it currently sells.
    • “The trials are bids to improve upon vaccines Merck currently markets as Gardasil and Gardasil 9. One will test a shot meant to provide protection against more strains of HPV. The other will evaluate a single-dose regimen of Gardasil 9. Both studies should begin in the fourth quarter of this year. 
    • “Gardasil is approved for use against genital warts and to prevent several cancers caused by stains of HPV. The vaccine is one of Merck’s top-selling products and still growing. It generated $8.9 billion in sales in 2023, up 29% from the previous year.” 
  • STAT News informs us,
    • “For four decades, researchers and companies searched for ways to replace the broken blood-clotting genes that cause hemophilia, a multibillion dollar effort designed to turn a chronic, sometimes debilitating disease into a curable one. 
    • “But the first two gene therapies have so far been met with crickets. Only a handful of patients with hemophilia B, the rarer form of the disease, appear to have been treated worldwide since Hemgenix was approved in November 2022. After Roctavian was approved for hemophilia A last June, only three patients were treated through the rest of the year.
    • “The issue doesn’t appear to be access. Hemgenix and Roctavian, marketed by the Australian biotech CSL Behring and the San Francisco biotech BioMarin, are Malibu-mini-mansion expensive: $3.5 million and $2.9 million, respectively. But current hemophilia treatments can run over $1 million per year. So most insurers have been happy to pay the lump sum.
    • “​​You can’t blame the payers this time,” said Michael Sherman, former chief medical officer of the nonprofit insurer Harvard Pilgrim.” 
  • The National Cancer Institute posted research highlights.
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have discovered that symptoms of attention-deficit/hyperactivity disorder (ADHD) are tied to atypical interactions between the brain’s frontal cortex and information processing centers deep in the brain. The researchers examined more than 10,000 functional brain images of youth with ADHD and published their results in the American Journal of Psychiatry. The study was led by researchers at NIH’s National Institute of Mental Health and National Human Genome Research Institute. * * *
    • “The findings from this study help further our understanding of the brain processes contributing to ADHD symptoms—information that can help inform clinically relevant research and advancements.”
  • The Institute for Clinical and Economic Review published a “Final Evidence Report on Treatments for Paroxysmal Nocturnal Hemoglobinuria. — Independent appraisal committee voted that current evidence is not adequate to demonstrate a net health benefit for iptacopan over C5 inhibitor; committee voted that the evidence is adequate to demonstrate a net health benefit for add-on danicopan compared to C5 inhibitor alone.”
  • Medscape relates,
    • “Chronic smoking remains a major cause of premature mortality on a global scale. Despite intensified efforts to combat this scourge, a quarter of deaths among middle-aged adults in Europe and North America are attributed to it. However, over the past decades, antismoking campaigns have borne fruit, and many smokers have quit before the age of 40 years, enabling some case-control studies.
    • “Among those abstainers who made the right choice, the excess mortality attributable to smoking over a lifetime would be reduced by 90% compared with controls who continued smoking. The estimated benefit is clear, but the analysis lacks nuance. Is smoking cessation beneficial even at older ages? If so, is the effect measurable in terms of magnitude and speed of the effect? An article published online on February 8, 2024, in The New England Journal of Medicine Evidenceprovided some answers to these questions.”

From the HIMSS conference front,

  • Healthcare IT News reports “Samsung focuses on intuitive mobile tech and wearables at HIMSS24. These technologies can help cure healthcare worker burnout, patient confusion and inefficient communications between care teams, says a top exec and nurse.”
  • Forbes explains why AI is taking center stage at the conference.
    • “At the HIMSS conference in Orlando, healthcare leaders, including CIOs, CMIOs, CNIOs, and other C-suite members, were focused on AI as the central theme. They explored how healthcare organizations can better utilize their clinical data. They identified security, AI platforms, and workforce optimization as the three main areas for healthcare AI development.”
  • In related news, Health IT Analytics lets us know,
    • “Researchers from Mount Sinai have been awarded a four-year, $3 million grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) to develop artificial intelligence (AI)-driven prediction models to flag risk of cardiovascular disease events in patients with obstructive sleep apnea.
    • “The American Heart Association (AHA) indicates that obstructive sleep apnea increases patients’ risk of cardiovascular disease, including coronary artery disease, hypertension and stroke. The use of continuous positive airway pressure (CPAP) machines is often prescribed to treat sleep apnea, but evidence to suggest the benefits of CPAP use in relation to cardiovascular event rates is limited.
    • “To bridge this gap, the research team will build machine learning (ML) tools to identify obstructive sleep apnea patients at high risk for atherosclerosis progression and cardiovascular events like stroke and heart attack.”

In other U.S. healthcare business news,

  • The Wall Stree Journal reports,
    • “People seeking a popular new weight-loss drug will have a new home-delivery option from a familiar name: Amazon.com.
    • “Amazon Pharmacy, which has sold prescription medicines online since 2020, will now handle some of the home delivery of anti-obesity therapy Zepbound and other Eli Lilly drugs that are ordered through the drugmaker’s new direct-to-consumer service, the companies said Wednesday.
    • “The service, called LillyDirect, connects patients with telehealth services specializing in obesity that can write prescriptions for Zepbound or another weight-loss drug. The service also arranges for a prescription to be processed and mailed directly to customers.” 
  • The Society for Human Resource Management notes,
    • “According to the latest Employer Costs for Employee Compensation report, released March 13 by the U.S. Bureau of Labor Statistics (BLS), employers spent 3.8 percent more on wages and benefits in December 2023 compared to September 2023.
    • “Total employer compensation costs for private-industry workers averaged $43.11 per hour worked in December 2023. Wages and salaries averaged $30.33 per hour worked and accounted for 70.4 percent of employer costs, while benefit costs averaged $12.77 per hour worked and accounted for the remaining 29.6 percent, according to the BLS report.
    • :That’s a significant jump from the total employer compensation costs for those same workers last fall, and one indicating that despite slowing compensation growth over the past year, bigger hikes are not yet over.”

Tuesday Tidbits

David Ermer–COVID-19, Cybersecurity, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Because this is the FEHBlog, the lede tonight necessarily is OPM’s announcement naming the carriers who are currently prepared Postal Service Health Benefit Program benefit and rate proposals. Good luck to them all.
  • FedWeek notes,
    • “President Biden has issued an open letter to federal employees thanking them for their “tireless service on behalf of our country.”
  • and
    • “While seeking a January 2025 raise of 2 percent (see related story), the White House’s fiscal 2025 budget proposal cites several initiatives related to federal pay.
    • “In addition to year-to-year pay increases, the Administration is pursuing structural reforms to enhance the competitiveness of the Federal pay system,” it says.
  • Reg Jones, writing in Fedweek, fills us in on benefits available upon the death of a federal employee or annuitant.
  • The Department of Health and Human Services provided a readout from “Biden-Harris Administration Convening with Health Care Community Concerning Cyberattack on Change Healthcare. Leaders from HHS, White House, DOL, and the health care community convened to discuss ways to mitigate harms to patient and providers caused by the cyberattack.”
  • The Food and Drug Administration “advised consumers in Some Medicines and Driving Don’t Mix to make sure they know if their prescription or over-the-counter medication can cause side effects that may make it unsafe to drive. Most medications won’t affect consumers’ ability to drive safely or operate other heavy machinery, but some do.”
  • The Buck consulting firm points out why “maintaining creditable coverage may prove difficult for some employer sponsored plans in 2025.”
  • STAT News discusses the treatment impact of new federal methadone rules.
    • “The federal government is reforming methadone care for the first time in over two decades. But how far do the changes actually go?
    • “To many methadone clinics, the Biden administration’s recent refresh of the rules governing opioid treatment programs represents an unprecedented opportunity to offer care that is more compassionate and responsive to patients’ needs. To many patient advocates, however, it simply nibbles around the edges. 
    • “The reality is likely somewhere in between: It will depend, in large part, on whether state-level regulators embrace the changes, and whether individual clinics actually implement them. In reform-oriented states, and at patient-centered clinics, the new rules could make a world of difference for people seeking addiction treatment.” 
  • The Office of National Coordinator for Healthcare Information Technology, Micky Tripathi, in his blog, looks forward to “HTI-2 & ONC’s Commitment to Furthering the Vision of Better Health Enabled by Data.”

From the public health and medical research front,

  • BioPharma Dive reports,
    • “Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday.
    • “A majority of patients receiving the highest dose of the drug, which is specially designed to penetrate brain tissue, saw their amyloid levels drop below detectable levels after 12 weeks, Roche executives said in an investor presentation on the pharmaceutical giant’s neurology pipeline.”
  • Reuters tells us, “Pfizer  said on Tuesday its drug, Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen [in 2023].
  • MedPage Today lets us know,
    • “Pragmatic implementation of an automated online behavioral obesity treatment program that included 9 months of active maintenance helped people with overweight or obesity lose a clinically significant amount of weight by 12 and 24 months, a randomized trial showed. * * *
    • “This pattern persisted at 24 months, reported J. Graham Thomas, PhD, of the Weight Control and Diabetes Research Center in Providence, Rhode Island, and colleagues in JAMA Internal Medicine.
    • “This study shows that a fully automated online obesity treatment program can produce beneficial results for many patients in real-world primary care settings,” Thomas told MedPage Today. “We were encouraged to find that the online weight-loss program performed just as well in real-world primary care practices as it does in our previous highly controlled clinical trials.”
    • “These patients lost weight “at rates comparable” to those seen in studiesopens in a new tab or window in which the researchers were completely hands-on in every aspect of the program, he added.
    • “Because the treatment program is online and fully automated, Thomas said it is quite practical for widespread implementation across primary care practices. “The data show that the primary care clinicians were able to implement the program independently, and patients were able to use it successfully.”
  • Beckers Hospital Review adds,
    • “Hospital transplant departments have strict cutoffs for patients with higher body mass indexes because of the increased risk of complications, but GLP-1s such as Ozempic and Wegovy are helping more patients be eligible for surgery. 
    • “Potential transplant donors and diabetic patients who otherwise would not be able to undergo surgery because of their BMI are now quickly dropping weight. Popular GLP-1s, including Ozempic, and GLP-1s and glucose-dependent insulinotropic polypeptides, such as Mounjaro and Zepbound, are dramatically helping these weight loss efforts.” 
  • Medscape cautions,
    • “Novo Nordisk’s CEO on Friday said the company was working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of patient harm across the world.
    • “This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drugmaker, told Reuters. * * *
    • “Jorgensen, echoing comments from the FDA’s Califf, also said compounded semaglutide in the United States was a serious health issue, and that the raw materials, or active pharmaceutical ingredients (API), for these products were coming from unregulated facilities in Asia and elsewhere. 
    • “We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product,” he said.
    • “While fake drugs often do not contain any of the medication advertised, compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. Because Wegovy and Ozempic are in short supply, they can be legally produced by licensed pharmacies in the U.S.
    • “Further reports obtained by Reuters through FOIA requests show that one person died last year from abnormal blood clotting after taking a drug that was advertised as compounded semaglutide. Three others suffered severe vomiting and nausea, sensory loss in their legs, and a drop in blood platelet levels.”
  • The U.S. Census Bureau announced,
    • “An additional 573,000 people died in the United States during the first year of the COVID-19 pandemic but “excess mortality” at the national level masks substantial variations by state, age, sex, and race and ethnicity, according to new U.S. Census Bureau research recently published in Demography.
    • “Excess mortality” refers to deaths from any cause above what is expected from recent mortality trends.
    • “This research shows the pandemic widened the mortality gap between the nation’s Black and White populations and completely erased the mortality advantage of the Hispanic population in relation to the non-Hispanic White population.”
  • The National Institutes of Health announced‘,
    • “Two phase 2 clinical trials to test the safety and effectiveness of three treatments for adults with autonomic nervous system dysfunction from long COVID have begun. The autonomic nervous system acts largely unconsciously and regulates bodily functions, such as heart rate, digestion and respiratory rate. Symptoms associated with autonomic nervous system dysfunction have been among those that patients with long COVID say are most burdensome. The trials are part of the National Institutes of Health’s Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program to fully understand, diagnose and treat long COVID. Other RECOVER phase 2 clinical trials testing treatments to address viral persistence and neurological symptoms, including cognitive dysfunction (like brain fog), launched in July 2023. * * *
    • “People 18 years of age and older who are interested in learning more about these trials can visit https://trials.RECOVERCovid.org/autonomic or ClinicalTrials.gov and search identifier NCT06305793, NCT06305806 and NCT06305780. Please do not contact the NIH media phone number or email to enroll in these trials.”
  • The Wall Street Journal warns,
    • “Ultra-processed foods may not only affect our bodies, but our brains too.
    • “New research suggests links between ultra-processed foods—such as chips, many cereals and most packaged snacks at the grocery store—and changes in the way we learn, remember and feel. These foods can act like addictive substances, researchers say, and some scientists are proposing a new mental-health condition called “ultra-processed food use disorder.” Diets filled with such foods may raise the risk of mental health and sleep problems. 
    • “The science is still early and researchers say there is a lot they don’t know. Not all ultra-processed foods are equal, some scientists say, adding that some might be good for you. A diet high in ultra-processed foods has been linked with obesity, Type 2 diabetes, cancer and cardiovascular disease, but researchers are still figuring out exactly why, beyond calorie counts and nutrient composition. 
    • “Makers of foods such as processed meats and muffins defend their products, and note that there isn’t a consistent, universally accepted definition of ultra-processed food.”

From the HIMSS Conference in Orlando,

  • HIMSS offers an article about “Google Cloud’s debut of new genAI advancements for healthcare at HIMSS24. In total, the company is offering its cloud clients updates to Vertex AI Search, Healthcare Data Engine and MedLM, designed to improve patient care.”

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Nearly half of U.S. workers don’t have the benefits they need at work, according to the results of a survey by Perceptyx, an employee experience company. Of the 1,500 full-time employees surveyed, 59% said they had “benefits envy” of friends’ and family members’ healthcare coverage.
    • “When it comes to benefits equity, the survey found that medical, maternity and mental health are the “magic trifecta,” Emily Killham, senior director of people analytics, research and insights at Perceptyx, said. “When employees have access to all three, women and men feel equally that their needs are met.”
    • “Yet 53% of those surveyed said they don’t have mental health coverage, 51% don’t have maternity leave, and 25% don’t have any medical benefits, per the results.”
  • Beckers Hospital Review informs us,
    • “Healthgrades recognized 832 hospitals with its 2024 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 79 of those hospitals received both awards. 
    • “The dual recipients spanned 27 states. Texas had the most dual recipients with 13 honorees — including four Baylor Scott and White Health and four Houston Methodist hospitals.”
    • The article lists the dual recipients.
  • Beckers Payer Issues relates,
    • “Selective contracting with primary care physicians may be one factor behind lower per-patient expenses in Medicare Advantage, a study published in the March edition of Health Affairs found. 
    • “The study examined 4,456,037 traditional Medicare patients who visited 151,679 primary care physicians. The physicians who participated in Medicare Advantage networks had $433 lower costs per patient than the regional average of physicians. 
    • “The quality measures for physicians participating in Medicare Advantage were similar to the regional average, the study found. 
    • “Physicians who did not participate in any MA networks cost $1,617 more per patient per year than those participating in MA networks, and they had lower quality measures. 
    • “The findings suggest that “managed care tools, particularly selective contracting with primary care physicians” contribute to lower costs in Medicare Advantage, the authors concluded. Though the differences in cost are most likely attributable to differences in practice style, that could also serve as a mechanism for plans to select healthier patients, the authors wrote.” 
  • Health Payer Intelligence adds,
    • “The average Medicare Advantage premium has remained low and stable, with many beneficiaries choosing plans with a zero-dollar monthly premium, according to data from eHealth, Inc.
    • “eHealth’s seventh annual Medicare Index Report includes data from over 190,000 applications for Medicare insurance products submitted to eHealth during the annual enrollment period for 2024 coverage.
    • “The average monthly premium for Medicare Advantage plans chosen by eHealth customers for 2024 is $9, the same as last year and up slightly from $6 in 2022. The popularity of plans with zero-dollar premiums contributed to the low average.”
  • HealthDay informs us,
    • “The cost to American families of caring for a child with a mental health condition jumped by almost a third between 2017 and 2021.
    • “It now costs an average $4,361 more per year for a U.S. family to care for a child with a mental health condition, compared to families without such children, a new study has found.” 

Monday Roundup

David Ermer–AHRQ, COVID-19, Electronic health records, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “President Biden proposed Monday a $7.3 trillion budget for the next fiscal year that would raise taxes on wealthy people and large corporations, trim the deficit and lower the costs of prescription drugs, child care and housing.
    • “The proposal isn’t expected to gain momentum in Congress, but will be a cornerstone of Biden’s re-election campaign as he looks to contrast his economic policies with those of presumed Republican presidential nominee Donald Trump. The administration has yet to reach an agreement with Congress on the budget for the current fiscal year, which began Oct. 1, and House Republicans have blasted Biden’s new proposal as reckless.
    • “The fiscal 2025 budget would cut the deficit by $3 trillion over the next decade, and it would raise taxes by a net total of $4.9 trillion, or more than 7% above what the U.S. would collect without any policy changes.” 
  • Here’s a link to the OMB page for the FY 2025 budget.
  • The Department of Health and Human Services offers a fact sheet on the budget measures impacting health insurance.
  • Govexec delves into the significant program reforms found in the budget details.
  • Federal News Network adds,
    • “For 2025, the White House is pushing for a more modest 2% federal pay raise for the roughly 1.5 million federal employees on the General Schedule.
    • “If enacted, most civilian federal employees would see the boost to their paychecks starting in the first full pay period of January 2025. Military members would receive a 4.5% raise next year, according to the budget request.
    • “The percentage adjustment would be the smallest pay raise since President Joe Biden took office. Federal employees received raises of 5.2%, 4.6% and 2.7%, in 2024, 2023 and 2022, respectively. In all three years, Biden’s federal pay raise proposals were finalized without intervention from Congress.
    • “The Biden administration said it opted for the smaller raise proposal for 2025 due to financial constraints agencies are expected to face over the next fiscal year.”
  • The U.S. Office of Personnel Management posted its FY 2025 Congressional Budget Justification and Annual Performance Plan. Here are OPM’s legislative proposals for FEDVIP and FEHBP/PSHBP:
    • “Expand Family Member Eligibility Under FEDVIP;
    • “Expand FEDVIP to Certain Tribal Employers;
    • “Expand FEHB to Tribal Colleges and Universities;
    • “Preempt State/Local Taxation of FEDVIP Carriers to Align with FEHB Carriers;
    • “Shorten FEDVIP Contract Terms to Allow Flexibility for New Carriers;
    • “Require Coverage of Three Primary Care Visits and Three Behavioral Health Visits Without Cost-Sharing;
    • “Limit Cost-Sharing for Insulin at $35 per Month.”
  • These proposals generally are retreads from earlier performance plans. If at first you don’t succeed, etc.

From the patient safety front,

  • HHS’s Agency for Healthcare Research and Quality reminds us that this is Patient Safety Awareness Week.
  • Fierce Healthcare tells us,
    • “Through no fault of their own, clinicians who started practicing medicine in the last several years didn’t have the same early experience as those who came before them–before the pandemic laid bare critical weaknesses in our healthcare system,” Marcus Schabacker, M.D., president and CEO of ECRI, said in a release. “ECRI’s top patient safety concern is a call to action to set new clinicians up for success through a ‘total systems safety’ approach and assess and redesign the environments in which clinicians are trained, onboarded, mentored and supported.”
    • “Among the recommendations proposed by ECRI and its affiliate, the Institute for Same Medication Practices (ISMP), in the patient safety report are new collaborative partnerships between healthcare and academic to support hands-on and simulation-based learning, as were wellness programs and adopting “a culture of safety that empowers newly trained clinicians to report safety events.”
    • “Just behind new hire challenges in ECRI’s 2024 ranking was concern that healthcare staff’s workarounds for barcode medication administration systems could lead to an increase in medication safety events.
    • “These workarounds occur when drug’s barcode can’t be scanned due to damage on a label, or when a medication hasn’t yet been added to an organization’s system, ECRI explained. This can lead to back-charting, proxy scanning, unlogged medication administration and ignored system alerts, and has historically been to blame for a majority of technology-related medication safety issues, according to the report.”
  • USAA Today reports,
    • “Beginning this year, the Centers for Medicare & Medicaid Services announced it would cover navigation services for older Americans on Medicare. The agency also established billing codes for hospitals and doctors to bill health insurance companies for navigator services.
    • “The Biden administration announced that seven large private health insurance companies have agreed to cover navigator services: Aetna, Blue Cross Blue Shield of Minnesota, Elevance Health, Health Alliance Plan, Humana, Priority Health and Select Health.
    • “In addition, 40 cancer care centers and clinics will extend navigator services to patients. The list includes high-profile cancer care centers such as Dana-Farber Cancer Institute in Boston, the Duke Cancer Institute, Northwell Health and the Mayo Clinic.
    • “This is about making sure that a growing number of Americans can get access as they need it,” Arati Prabhakar, director of the White House Office of Science and Technology Policy, told USA TODAY. “The companies that have signed up to provide insurance coverage for these services … reach 150 million Americans.”

From the Food and Drug Administration front,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results that proved the medicine can protect heart health. 
    • “The agency on Friday approved use of Wegovy to reduce the risk of heart attacks, strokes or death in people with cardiovascular disease and who are either obese or overweight. The drug should be used alongside exercise and a reduced-calorie diet, the agency said. 
    • “Wegovy, part of a popular class of medicines that control blood sugar and appetite, is already approved for use in treating obesity. The drug generated about $4.5 billion in sales in 2023 despite manufacturing issues that made it difficult for the company to meet surging demand.” * * *
    • “The FDA clearance issued Friday is one step in that direction. It was based on the results of a large study, the results of which were published in The New England Journal of Medicine last year, showing that treatment with Wegovy reduced the risk of heart attack, stroke or cardiovascular death by 20% compared to a placebo.” 
  • MedTech Dive lets us know,
    • “A Food and Drug Administration advisory committee has voted that the benefits of a new agent used in Lumicell’s breast cancer imaging tool outweigh the risks.
    • “The committee, which convened last week, assessed evidence that the tool can detect residual cancer in real-time during breast conserving surgery. Detecting residual cancer during surgery could reduce the need for additional procedures.
    • “While the committee supported the risk-benefit profile of the agent, pegulicianine, by a 16-2 vote, many of the experts noted its limitations, with one panelist who voted yes saying that the “incremental benefits outweigh the small risks of anaphylaxis.”

From the public health and medical research front,

  • David Leonhardt writing in the New York Times reflects on the fourth anniversary of the beginning go of the Covid shutdown in the U.S.
  • The American Medical Association tells us what doctors wish their patient knew about sickle cell disease.
  • The Institute for Clinical and Economic Review posted a “Final Evidence Report on Treatment for Schizophrenia — An independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for KarXT compared to generically available aripiprazole; if long-term data confirm KarXT’s benefits and lack of weight gain, it would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year.
  • Beckers Hospital Review relates,
    • “Pfizer’s shortage of penicillin G benzathine injection, an antibiotic for syphilis and other bacterial infections, is now predicted to last until the end of 2024. 
    • “Pfizer previously said the medication’s supply would rebound by the end of June, but in a March 8 update on the FDA’s drug shortage website, the drugmaker said the estimated recovery date is the fourth quarter of 2024. 
    • “Two solutions are in limited availability and another, the 600,000 [iU]/1 mL solution, is unavailable until its next shipment in April. 
    • “The FDA first reported the supply issue in April 2023, and Pfizer then said it would end within five months. A year later, clinicians are rationing penicillin, and the U.S. is importing solutions from a France-based drugmaker as syphilis rates dramatically increase.”

From the HIMSS global conference front,

  • This week, HIMSS is holding its popular global conference in Orlando, Florida.

From the U.S. healthcare business front,

  • Fierce Healthcare discusses lobbying efforts to obtain a Congressional extension of Medicare’s hospital at home program.
  • Healthcare Dive notes,
    • “Elevance Health said on Monday it closed its deal to acquire infusion and drug therapy company Paragon Health.
    • “Under the deal, the insurer will expand Plano, Texas-based Paragon’s real estate footprint and scale up operations, according to the announcement. Paragon will operate under CarelonRx, Elevance’s pharmacy services segment.
    • “An Elevance spokesperson declined to share financial terms of the deal. However, Axios, citing sources familiar, reported the purchase would run Elevance over $1 billion.”
  • Beckers Hospital Review ranks 34 health systems by operating margin.
  • Medscape informs us,
    • “A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were.
    • “The civil suit alleges that Aledade, Inc.’s, billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records.
    • “Aledade did whatever it took to make patients appear sicker than they were,” according to the suit.”
  • HR Dive reminds us,
    • “The U.S. Department of Labor’s independent contractor final rule went into effect Monday, after businesses scrambled last week to have it enjoined or halted through a preliminary injunction. 
    • “DOL announced the final rule in January, more than a year after it proposed changes to its evaluation of workers’ independent contractor status in October 2022. 
    • “The new “totality-of-the-circumstances” framework uses six nonexhaustive factors to determine workers’ independent contractor status, including the nature and degree of control over the work, extent to which the work performed is an integral part of the employer’s business and permanence of the arrangement. 

Happy International Women’s Day

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, NIH, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Dulcey Lima on Unsplash

The International Foundation of Employee Benefit Plans celebrates International Women’s Day. “International Women’s Day is an ideal time to pause and reflect on the status of women in the workforce—both how far we’ve come and how far we still need to go to achieve true gender equality. “

Mercer Consulting adds, “Women are hugely concerned about the state of their personal finances – and too often, employers have fallen short of providing the support their people need. For too long, financial health has trailed behind physical and mental health on the list of employers’ priorities. Now is the time to act!” The article explains how to act.

From Washington, DC,

  • The Wall Street Journal reports,
    • The Senate on Friday passed a $460 billion spending bill to keep the U.S. government operating, taking a potential shutdown for several agencies off the table for the rest of the fiscal year.
    • In a 75-22 vote, Senate lawmakers approved budgets for federal agencies including the Agriculture, Justice, Transportation and Interior departments through the end of September, just hours before some agencies were scheduled to run out of money. The vote came after several nervous hours of negotiations over votes on amendments demanded by Republicans as a condition for the final vote.
    • The measure now heads to President Biden for approval.
  • Healthcare Finance News adds,
    • “A 3.34% physician payment reduction began January 1. [spending] The legislation  [includes] a prospective increase of 1.68% to Medicare physician reimbursement effective March 9, according to MGMA.
    • “Medical groups would still be left with a 1.69% reduction in reimbursement for the rest of the year.”
  • Fierce Healthcare informs us,
    • “[On Thursday night,] President Joe Biden promised the country further action on prescription drug prices, insurance coverage and reproductive care access during a State of the Union Address that doubled as an early campaign speech.
    • With a presidential election months away, the White House hasn’t held back from promoting its recent efforts on issues at the front of voters’ minds such as the cost of American healthcare and abortion. Though Biden’s address included several calls for policy support from Congress, he wasn’t shy about making his pitch directly to watching voters who could tip the scales in his office’s favor. * * *
    • “Biden asked Congress to build upon the Inflation Reduction Act (IRA) to increase the number of products subject to Medicare drug price negotiations.
    • Rather than the current 20-drug-per-year limit, Biden asked lawmakers for the authority to negotiate prices for 50 drugs a year, or “500 different drugs over the next decade,” he said.
    • “Additionally, the president called to extend the $2,000 out-of-pocket cap on prescription Medicare drugs (set to go into effect in 2025) to all private insurance.
    • “Per the fact sheets, he is also pushing for a similar expansion of another IRA requirement—that drug manufacturers pay rebates to Medicare for certain drug price increases that exceed inflation—to the commercial market. He illustrated that goal during the address by calling for Medicare’s $35-per-month cap on insulin to apply “to every American.”
  • The U.S. Office of Personnel Management issued its FEHB and PSHB technical guidance to carriers who are preparing 2025 benefit and rates proposals in response to the February 8, 2024, call letter.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “A large clinical trial meant to confirm the benefits of a new ALS medication has instead failed, dealing a major blow to the therapy’s developer as well as patients who had hung their hopes on it.
    • “Amylyx Pharmaceuticals disclosed Friday morning that the drug, known as Relyvrio in the U.S., didn’t meet the trial’s main or secondary goals. Though well-tolerated by participants, Relyvrio was not significantly better than a placebo at changing the trajectory of their disease.
    • “For Amylyx, the results are a monumental setback. The Massachusetts-based biotechnology company was built entirely around Relyvrio, which received approval from the Food and Drug Administration in the fall of 2022. Early sales made Amylyx profitable – a rare victory for any young drugmaker. * * * By the end of September, nearly 4,000 of the roughly 30,000 ALS patients in the U.S. were on Relyvrio, according to Amylyx’s estimates. * * *
    • “Now, the company’s future is unclear. Before Relyvrio’s approval, Amylyx co-founders Justin Klee and Joshua Cohen pledged, at the request of a top FDA official, to pull their drug from the market should confirmatory testing fail.
    • “In a statement, Amylyx said that sometime in the next eight weeks, it will share its plans for Relyvrio, which “may include voluntarily withdrawing [the drug] from the market.” The company also intends to discuss the new results with regulators, doctors and the broader amyotrophic lateral sclerosis community.
    • “In the meantime, Amylyx will pause promoting the product.”
  • STAT News tells us,
    • “In a surprise move, the Food and Drug Administration has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved, even as many outsiders expected the medicine to receive regulatory clearance this month.
    • “The drug, donanemab, succeeded in its Phase 3 trial, resulting in a 35% slowing of Alzheimer’s disease progression versus placebo. But Lilly on Friday said that the FDA expects to call a meeting of an advisory committee to review the trial, saying that the agency had told the company “it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design” of the study.
    • “A date for the meeting has not been set yet.
    • “Lilly previously said a regulatory decision was expected by the end of 2023, but had already pushed that back to the first quarter of 2024. In its statement Friday, it said simply that “the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024.”

From the public health and medical research front,

  • The Hill informs us,
    • “The rash of measles outbreaks around the country has sparked concerns that the U.S. risks losing its status as a country where the disease has been eliminated, a distinction held since 2000.
    • “As of last week, 41 measles cases have been confirmed across 15 states and New York City, according to the Centers for Disease Control and Prevention (CDC). That puts the nation already on track to surpassing the 58 total cases that were detected in 2023.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services unveiled a new Framework to accelerate smoking cessation and reduce smoking- and cessation-related disparities.  This action is part of a broader Department-wide effort to advance the Biden Cancer Moonshot goal of reducing the death rate from cancer by at least half over 25 years.
    • “Every person in America should have access to the tools and programs they need to quit smoking. And we must encourage and assist every person in America who wants to quit smoking to do so,” said Secretary Xavier Becerra. “This framework focuses on advancing equity, engaging communities, and coordinating, collaborating, and integrating evidence-based approaches across every facet of our government and society. The Biden-Harris Administration will continue these efforts until smoking is no longer the leading cause of preventable death in the United States, and the communities that remain the most vulnerable get the help they need.”
    • “The HHS Framework to Support and Accelerate Smoking Cessation – PDF provides a unifying vision and set of common goals to help drive progress towards cessation, especially in populations and communities that experience smoking- and cessation-related disparities. It is focused specifically on supporting and accelerating the cessation of combusted tobacco products, including cigarettes, cigars, little cigars, and cigarillos among people of all ages.”
  • The National Institutes of Health announced,
    • “A topical liquid, silver diamine fluoride (SDF), can stop tooth decay in young children, according to a large clinical trial funded by the National Institutes of Health. The preliminary results, published in Pediatric Dentistry, showed that 54% of cavities stopped progressing after SDF treatment, compared to 21% of those treated with a placebo. The study was funded by the National Institute of Dental and Craniofacial Research (NIDCR), part of NIH.
    • “SDF is cleared by the Food and Drug Administration for treating dental sensitivity and is used off label to treat tooth decay, also known as cavities or dental caries. It can be easily and painlessly swabbed onto cavities and has been widely used for management of tooth decay in other countries for decades. Studies suggest that the silver in SDF kills cavity-causing microbes and helps stop destruction of the tooth, while the fluoride helps to rebuild and strengthen the tooth.
    • “Current treatments for severe early childhood caries rely on restoration and tooth extraction, which can involve general anesthesia,” said lead investigator Margherita Fontana, D.D.S., Ph.D., of the University of Michigan. “These interventions are expensive, cavities often return, and anesthesia can have long-term effects on a developing brain. We didn’t really have any other options until recently — SDF is a game changer.”
  • The New York Times relates,
    • “Increasingly, doctor visits by adolescents and young adults involve mental health diagnoses, along with the prescription of psychiatric medications.
    • “That was the conclusion of a new study that found that in 2019, 17 percent of outpatient doctor visits for patients ages 13 to 24 in the United States involved a behavioral or mental health condition, including anxiety, depression, suicidal ideation, self-harm or other issues. That figure rose sharply from 2006, when just 9 percent of doctor’s visits involved psychiatric illnesses.
    • “The study, published Thursday in JAMA Network Open, also found a sharp increase in the proportion of visits involving psychiatric medications. In 2019, 22.4 percent of outpatient visits by the 13-24 age group involved the prescription of at least one psychiatric drug, up from 13 percent in 2006.”
  • The Wall Street Journal points out,
    • “More parents with young children are taking melatonin to sleep. And some of them are going to the emergency room after their children took melatoninaccidentally. 
    • “The number of children who visited emergency rooms for unsupervised melatonin consumption increased 420% from 2009-2020, federal data showed. Melatonin was implicated in some 7% of recent E.R. visits for children 5 and younger who had taken medication without supervision. 
    • “The good news: Very few of those children were hospitalized. Typically, mild drowsiness, headaches or dizziness are the worst side effects after children consume melatonin, according to America’s Poison Centers.
    • “Adults have long used melatonin, a hormone the brain produces in response to darkness, to regulate their sleep. It is sold widely as a dietary supplement.”
  • The MIT Technology Review lets us know,
    • “As a fetus grows in the womb, it sheds cells into the amniotic fluid surrounding and protecting it. Now researchers have demonstrated that they can use those cells to grow organoids, three-dimensional structures that have some of the properties of human organs—in this case kidneys, small intestines, and lungs. These organoids could give doctors even more information about how fetal organs are developing, potentially enhancing prenatal diagnoses of conditions like spina bifida.
    • “These aren’t the first organoids produced from fetal cells. Other groups have grown them from discarded fetal tissue. But this group is among the first to grow organoids from cells taken from amniotic fluid, which can be extracted without harming the fetus.
    • “The entire concept is really groundbreaking,” says Oren Pleniceanu, a stem cell biologist and head of the Kidney Research Center at Sheba Medical Center and Tel-Aviv University who has also been working on organoids from amniotic fluid. This ability to get fetal cells from the amniotic fluid, “it’s like a free biopsy,” he says. But he points out that there’s still room for improvement when it comes to describing the cells that are present. “It’s not that easy to define which cells these are,” he says.”  

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “The No Surprises Act, which aims to protect patients from costly surprise medical bills is becoming “an unmitigated disaster for employers,” according to the head of the one of the largest industry groups for employer-sponsored health plans. 
    • “The trends are bad and getting significantly worse, and I really do worry that we’re going to see a trend towards much higher inflationary factors,” Shawn Gremminger, president and CEO of the National Alliance for Healthcare Purchaser Coalitions, said at a Georgetown University forum on the No Surprises Act Thursday.
    • “The law has largely protected consumers from “surprise” bills in emergencies and when they receive care from out-of-network medical providers at facilities that are in their insurance networks.
    • “But employers and health insurers that pay the bills say they are increasingly alarmed at high awards private-equity owned providers are winning in arbitration, which they say could lead to higher premiums for both employers and their enrollees, as well as higher out-of-pocket costs for consumers.”
  • How does one square this report with yesterday’s CBO report about the savings that the NSA is producing? Providers generally accept the qualifying payment amounts the No Surprises Act requires them to pay.
  • The Employee Benefit Research Institute posted an Issue Brief about “Health Savings Account Balances, Contributions, Distributions, and Other Vital Statistics: Evidence From the EBRI HSA Database”
  • Healthcare Dive offers details on UHC updates on the Change Healthcare situation.
    • Change Healthcare systems are expected to come back online starting in mid-March, about a month after a cyberattack disabled the technology firm, parent company UnitedHealth Group said Thursday. 
    • Electronic payments will be available beginning March 15, and electronic prescribing is fully functional as of Thursday. Change will start testing its claims network and software on March 18, with plans to restore service through that week.
    • UnitedHealth also said it would give additional financial relief to providers, including advancing funds weekly and expanding the temporary financing program it announced earlier this month.
  • Healthcare Dive also delves into Cigna’s announcement that
    • “Cigna is moving to limit how much health insurance providers and employers have to pay for pricey and in-demand obesity medications.
    • “The insurer plans to cap annual price increases for the drugs, called GLP-1 receptor agonists, at 15% for employers and plans participating in a weight loss management program offered by its pharmacy benefit manager.
    • “It’s the first financial guarantee available in the market for the drugs, according to the payer. Cigna’s health services division Evernorth, which includes PBM Express Scripts, announced the news on Thursday before the insurer’s investor day in New York City.”
  • Business Insurance adds,
    • “Cigna Group’s Evernorth Health Services is launching an outpatient behavioral health practice to integrate mental health services with medical care, Forbes reports. The new service, currently available in six states and Washington, D.C., guarantees an appointment with a clinician matching the patient’s unique goals and preferences within 72 hours. Evernorth plans a nationwide rollout by early 2025.”
  • Beckers Health IT notes,
    • “The average cost per email for patients to message their provider was $39, according to data compiled and reported by Peterson-Kaiser Family Foundation.
    • “KFF examined data from the Health Care Cost Institute on physician and outpatient claims from 2020 and 2021 for patients under the age of 65 years old with employer-sponsored insurance. Billing codes for email interactions were first introduced in 2020 amid the COVID-19 pandemic for providers to bill insurers for at least 5 minutes spent responding to patient-initiated emails.
    • “The analysis focused on email messages associated with charges. Researchers found the average claim for emailed correspondence was $39, and patients paid around $25 out of pocket, according to the report. Depending on their benefits package, some patients paid up to $40 out of pocket.”
  • Per Fierce Healthcare,
    • “Renton, Washington-based Providence closed out its year with a -4.1% operating margin and a $596 million net loss but touted “significant progress in operating performance” and an 8.7% year-over-year gain in total operating revenues outpaced by a 7.3% rise in total operating expenses.
    • “The 51-hospital Catholic system was coming off a year of heavy expenses and organizational upheaval. In 2022, it had logged a -6.4% operating margin from a $1.7 billion operating loss, which included $247 million tied to a restructuring it had launched to address spending, as well as a $2.7 billion net loss (excluding $3.4 billion tied to its split with Hoag Memorial Hospital Presbyterian).
    • “This time around, Providence whittled its operating losses down to about $1.2 billion and highlighted gains in volumes. Specifically, it saw a 4% uptick in acute adjusted admissions, a 5% increase in case-mix adjusted admissions and a 3% decline in length of stay “as access to post-acute care improved.” Non-acute volumes also grew 2% on the back of an 11% increase in outpatient surgeries and procedures.”
  • Beckers Payer Issues points out three BCBS companies reporting 2023 losses “due to ongoing trends such as rising utilization in the Medicare Advantage space and growing demand for weight loss drugs. 

Thursday Miscellany

David Ermer–Cybersecurity, HSA, Medical / Rx research, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Congressional Budget Office posted a presentation about “CBO’s Approach to Estimating the Budgetary Effects of the No Surprises Act of 2021.”
    • “This presentation describes CBO’s approach to estimating the budgetary effects of the No Surprises Act. The stated aim of the No Surprises Act was to protect patients from surprise billing. The law:
    • “Established protections for patients receiving out-of-network care,
    • “Established an arbitration process for resolving payment disputes, and
    • “Directed arbiters to consider the qualifying payment amount, defined as the median in-network rate, as the benchmark for payment (with other factors).
    • “CBO projected that reductions in prices paid to providers would reduce insurers’ costs, in turn reducing premiums by roughly 1 percent and reducing federal deficits from 2021 to 2030 by a total of $17 billion.”
  • The Internal Revenue Service warned consumers to “Beware of companies misrepresenting nutrition, wellness and general health expenses as medical care for FSAs, HSAs, HRAs and MSAs.”
  • Fedweek tells us,
    • “In a series of recent reports, the OPM inspector general’s office said it has identified misspending in the FEHB program, which adds to the cost of premiums both for the enrollees and the government, but that legal barriers prevent the program from recouping some of that amount.
    • “A report covering the last three months of 2023 is typical in noting that the FEHB program is precluded from pursuing cases under the Anti-Kickback Statute, which makes it illegal for health care providers to knowingly and willfully accept bribes or other forms of remuneration in return for activities such as patient referrals.”
  • Query me this. How can there be misspending when Congress decided in 1996 not to apply this law to the FEHBP because it is operated by commercial entities? It’s sour grapes.
  • Federal News Network informs us,
    • The Office of Personnel Management’s retirement backlog made huge improvements in claims processed for February reaching 10,025, the highest number since April 2023. OPM received  8,794 claims in February and managed to process more than 3,000 claims compared to January.
    • After seeing a large increase in the inventory backlog in January, OPM made small improvements shrinking the backlog by 1,231  to a total of 19,591 claims in February. With a slight decrease in the backlog, OPM is still over 6,000 claims above the steady goal of 13,000.
    • OPM also saw improvements for the average processing time for February,  reaching 47 days, setting a new record.

From the public health and medical research front,

  • STAT News reports good news,
    • “A new monoclonal antibody product to protect against respiratory syncytial virus was 90% effective at preventing little children from being hospitalized with RSV, according to new data from the first season it was in use.
    • “The data, published Thursday in Morbidity and Mortality Weekly Report, a Centers for Disease Control and Prevention publication, looked at how well Beyfortus worked in the children whose parents managed to secure a scarce dose of the drug. These are the first real-world data showing how effective the product was in the United States.
    • “It’s basically really good news,” said Sean O’Leary, a professor of pediatrics at the University of Colorado School of Medicine and a pediatric infectious diseases specialist at Children’s Hospital Colorado. “In some clinical trials we see some level of effectiveness … but then when it’s rolled out in the real world, for any number of potential reasons, things don’t work out as well as they had in the clinical trials.”
    • “In this case, it’s great. The point estimate they came up with is even better than in the clinical trials,” said O’Leary, who was not involved in the study.
    • “AstraZeneca and Sanofi jointly developed Beyfortus, which is sold in the U.S. by Sanofi.”
  • and
    • “A pill being developed by Danish drugmaker Novo Nordisk may lead to greater weight loss than the obesity therapy Wegovy, the company reported Thursday, citing early data.
    • “In a Phase 1 trial, participants experienced an average of 13.1% weight loss after 12 weeks of taking the experimental oral medicine amycretin, according to data presented at an investor meeting. In comparison, in an earlier Phase 3 trial of the injectable drug Wegovy, people taking Wegovy lost about 6% of their body weight over the same time period. * * *
    • “Novo Nordisk isn’t the only pharma company working on a pill. An experimental pill being developed by Eli Lilly led to 14.7% weight loss in a 36-week, Phase 2 trial. Pfizer had been developing an oral medication, as well, but opted to shut down that product’s developmentdue to disappointing trial results.
    • “Many other companies are also testing oral obesity drugs, according to the STAT Obesity Drug Tracker.”

From the U.S. healthcare business front,

  • Beckers Hospital Review considers why healthcare cyberattacks last so long.
    • “The cyberattack on Change Healthcare that has caused disruptions across a wide swath of the industry has entered its third week. But why do these IT outages last so long?
    • “It’s a combination of ensuring that the hackers are no longer in the system and securing the vulnerability that allowed them to breach it in the first place, according to John Riggi, national advisor for cybersecurity and risk at the American Hospital Association.
    • “The victim must figure out how the bad guys broke into their network, where they are, throw them out and then seal that technical ‘hole,'” Mr. Riggi told Becker’s. * * *
    • “But Mr. Riggi, who spent more than two decades at the FBI, said it could take even longer to fully recover. “These disruptions could linger for several months or a year, and legacy systems that may not have been backed up or destroyed during the attack may become totally unrecoverable,” he said.”
  • United Healthcare offers a March 7 update on its Change Healthcare cyber response website.
  • Beckers Hospital Review also names ten drugs poised to be best seller this year and discusses “Newsweek‘s 2024 “America’s Greatest Workplaces for Women” ranking, which includes hospitals and health systems.”
  • Business Insurance reports,
    • While inflation in the general economy has slowed since 2022, workers compensation payment growth is still at levels higher than in 2020, experts with the Workers Compensation Research Institute said Tuesday.
    • Changes in medical care utilization and mix of services continue to affect workers comp pricing, and the recent trend of health care labor shortages, especially in nursing, is also contributing to higher costs, panelists said during a session at the 2024 WCRI Issues & Research Conference.
  • The Hill relates,
    • Drugmaker Boehringer Ingelheim plans to cap the out-of-pocket costs for all its inhalers at $35 per month after coming under fire from Democratic lawmakers over pricing. 
    • The company announced Thursday that the program will start June 1. It’s aimed at patients with employer-sponsored insurance, and those who are underinsured and uninsured, meaning they likely have to pay cash. 

Midweek Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Federal News Network reports,
    • “The House passed a $460 billion package of spending bills Wednesday that would keep money flowing to key federal agencies through the remainder of the budget year. The Senate is expected to take up the legislation before a midnight Friday shutdown deadline.
    • “Lawmakers are negotiating a second package of six bills, including defense, in an effort to have all federal agencies fully funded before a March 22 deadline. In the end, total discretionary spending set by Congress is expected to come in at about $1.66 trillion for the full entire year. 
    • “A significant number of House Republicans have lined up in opposition to the spending packages, forcing House Speaker Mike Johnson, R-La., to use an expedited process to bring the bill up for a vote. That process requires two-thirds of the House to vote for the measure for it to pass.
    • “The House passed the measure by a vote of 339-85.”
  • The American Hospital Association News adds,
    • “The House March 5 voted 382-12 to pass the AHA-supported Preventing Maternal Deaths Reauthorization Act (H.R. 3838), bipartisan legislation that would reauthorize federal support for state-based committees that review pregnancy-related deaths to identify causes and make recommendations to prevent future mortalities. Passed by the House Energy and Commerce Committee last July, the bill also would require the Centers for Disease Control and Prevention to work with the Health Resources and Services Administration to disseminate best practices to prevent maternal mortality to hospitals and other health care providers.”
  • Per an HHS press release,
    • “Today, in support of President Biden’s Unity Agenda, the U.S. Department of Health and Human Services’ Health Resources and Services Administration (HRSA) announced the launch of nearly $50 million for HRSA’s Rural Opioid Treatment and Recovery Initiative and released the initiative’s funding application. Funding will support establishing and expanding comprehensive substance use disorder treatment and recovery services in rural areas, including by increasing access to medications for opioid use disorder, such as buprenorphine. Opioid use disorder is particularly concerning in rural communities and accessing treatment can be challenging due to geographic isolation, transportation barriers, and limited substance use disorder providers. This week, HRSA hosted more than 800 rural community leaders working at the grassroots level to build their communities’ capacity to turn the tide of the opioid epidemic. * * *
    • “Applications will be accepted through May 6, 2024, and the funding opportunity is posted at: https://grants.gov/search-results-detail/349409.
    • “To learn more about other programs under the Rural Communities Opioid Response Program, visit https://www.hrsa.gov/rural-health/opioid-response.”
  • Govexec tells us,
    • “Coming on the heels of debuting its new public-facing repository of high-ranking federal officials, the Office of Personnel Management released guidance last week outlining how agencies should report data to the website and how often. 
    • “The March 1 guidance details how agencies will comply with the Periodically Listing Updates to Management (PLUM) Act, which moved OPM away from maintaining the quadrennial Plum Book after this year to an annually updated website that offers information about senior agency leaders, Senior Executive Service members and other top or non-competitively appointed officials. 
    • “OPM officials launched the new website in January, phasing out the physical Plum Book that dated back to President Eisenhower’s 1952 request for a list of every position his administration would have to fill. 
    • “At the time of its launch, the PLUM reporting website possessed the names, roles and pay levels of more than 8,000 executives, with plans to grow to 10,000 with subsequent updates.”
  • The Hill notes,
    • “Alabama Gov. Kay Ivey (R) signed a bill Wednesday protecting in vitro fertilization (IVF) providers from the state Supreme Court’s recent ruling that frozen embryos are to be considered children. 
    • “The legislation, titled SB 159, will shield IVF providers from lawsuit or criminal charges over the “death or damage to an embryo,” during the IVF process. The bill passed by both the state Senate and House shortly before heading to Ivey’s desk Wednesday night.” 

From the FEHB front,

  • An expert, writing in Govexec, offers tips for federal retirees on making the decision whether or not to enroll in Medicare Part B. FEHBlog tip — Income adjusted Medicare Part B premiums usually are temporary while the Medicare Part B late enrollment penalty is forever.
  • Reg Jones, writing in FedWeek, discusses “Your Federal Benefits in Divorce.”

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

  • HR Morning offers employers guidance on how to improve employee health.
  • The National Institutes of Health announced,
    • “More than 70% of American Indian young adults aged 20-39 and 50% of American Indian teens have cholesterol levels or elevated fat in the blood that put them at risk for cardiovascular disease, suggests a study supported by the National Institutes of Health. In some cases, these levels — specifically high low-density lipoprotein (LDL) cholesterol, often thought of as “bad cholesterol,” — were linked to plaque buildup and cardiovascular events, such as heart attack and stroke.
    • “The findings, published in the Journal of the American Heart Association, came from a 19-year-review of the Strong Heart Family Study, part of the Strong Heart Study — the largest study of cardiovascular health outcomes and risk factors among American Indian adults. Researchers followed more than 1,400 participants, ages 15-39, between 2001-2003 and 2020. At the beginning of the study, 55% of participants ages 15-19 had abnormal cholesterol levels, as did 74% of those ages 20-29, and 78% of those ages 30-39.”
  • and
    • “Four children have remained free of detectable HIV for more than one year after their antiretroviral therapy (ART) was paused to see if they could achieve HIV remission, according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. The children, who acquired HIV before birth, were enrolled in a clinical trial funded by the National Institutes of Health in which an ART regimen was started within 48 hours of birth and then closely monitored for drug safety and HIV viral suppression. The outcomes reported today follow planned ART interruptions once the children met predefined virological and immunological criteria.”
    • “These findings are clear evidence that very early treatment enables unique features of the neonatal immune system to limit HIV reservoir development, which increases the prospect of HIV remission,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “The promising signals from this study are a beacon for future HIV remission science and underscore the indispensable roles of the global network of clinicians and study staff who implement pediatric HIV research with the utmost care.”
  • and
    • “Long-acting, injectable antiretroviral therapy (ART) suppressed HIV replication better than oral ART in people who had previously experienced challenges taking daily oral regimens and was found safe in adolescents with HIV viral suppression, according to two studies presented today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. Both studies were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, in collaboration with other NIH institutes.
    • “The HIV community is just beginning to unpack the enormous potential of long-acting antiretroviral medications for HIV treatment and prevention, and we need population-specific data for everyone to benefit,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “These findings open up new possibilities for millions of people with HIV, particularly those whose health suffers due to challenges of daily pill taking.”
  • MedPage Today lets us know,
    • “Rates of emergency surgery, serious complications, and hospital readmissions were higher among Medicare patients living in primary care shortage areas, according to a cross-sectional retrospective cohort study of data from 2015 to 2019.
    • “Medicare beneficiaries living in areas with the most severe primary care shortages had higher rates of three types of emergency surgeries compared with those living in areas with the least severe shortages (37.8% vs 29.9%; risk ratio [RR] 1.26, 95% CI 1.17-1.37, P<0.001), reported Sara Schaefer, MD, of the University of Michigan in Ann Arbor, and co-authors.
    • “Those in areas with the most severe shortages were also more likely to have serious complications (14.9% vs 11.7%; adjusted RR 1.27, 95% CI 1.12-1.44, P<0.001) and readmissions (15.7% vs 13.5%; adjusted RR 1.16, 95% CI 1.01-1.33, P=0.03), they noted in Health Affairs.
    • “However, beneficiaries in areas with the most and least severe shortages had similar rates of 30-day mortality (5.6% vs 4.8%; adjusted RR 1.17, 95% CI 0.93-1.47, P=0.17) and any complications (25.9% vs 24.5%; adjusted RR 1.05, 95% CI 0.97-1.15, P=0.21).
    • “Schaefer told MedPage Today that what surprised her most about the study was the strength of the association for the primary endpoint. Across multiple iterations of analyses, the trend remained consistent, she said.”
  • Health Day relates that according to “researchers reported March 5 in the American Heart Association journal Circulation: Arrhythmia and Electrophysiology.”
    • “Sugary and diet drinks both appear to increase the risk of atrial fibrillation.
    • “Two liters weekly of diet drinks increased risk by 20%, and sugary drinks raised risk by 10%.
    • “Conversely, one liter weekly of unsweetened fruit or vegetable juice lowered risk by 8%.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Pittsburgh-based UPMC, a 40-hospital system, has reported a 2023 operating loss of $198.3 million (-0.7% operating margin) on revenue of $27.7 billion. 
    • “Those figures compare with a $162.1 million operating gain on revenue of $25.5 billion in 2022. Expenses in 2023, totaling $27.9 billion, were approximately 10% up on 2022. That included a 13.6% jump in insurance claims expenses. 
    • “The healthcare system’s measure of inpatient activity grew 3% over the previous year while average outpatient revenue per workday rose 10% and average physician revenue per weekday grew by 9%.”
  • Beckers Hospital Review points out four U.S. hospitals with uncertain futures.
  • Beckers Hospital Review also reports,
    • “Mark Cuban Cost Plus Drug Co. plans to begin manufacturing epinephrine and norepinephrine this week at its 22,000-square-foot drug facility in Dallas, Mr. Cuban confirmed to Becker’s on March 5. 
    • “The $11 million drug manufacturing plant, which originally planned to start operating in late 2022, will focus on producing injectable drugs that often fall into shortages. 
    • “Epinephrine is an emergency treatment for severe allergy reactions, and norepinephrine is a blood pressure medication. Injection solutions of the former have been in unsteady supply since at least 2012. Neither the FDA nor the American Society of Health-System Pharmacists list norepinephrine as a current shortage. 
    • “Next on the docket are pediatric oncology drugs, according to Fortune and Politico.” 
  • Beckers Payer Issues calls attention to the fact that
    • “Twenty-six states [listed in the BPI article] now have more than half of their Medicare enrollees in Medicare Advantage plans, according to a March 5 report from Chartis, a healthcare advisory services firm. 
    • “Nationwide, half of Medicare-eligible beneficiaries are now enrolled in Medicare Advantage plans.”