Tuesday Tidbits

Mental health care

Tuesday Tidbits

David Ermer–Congress, Electronic health records, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Modern Healthcare reports,
    • “Lawmakers and executives from three major pharmacy benefit managers presented diametrically opposing views at a heated Capitol Hill hearing Tuesday, as major bills aimed at reining in the organizations remain stalled in Congress. 
    • “Members of the House Committee on Oversight and Accountability blamed the highly concentrated PBM industry for raising drug prices and running independent pharmacies out of business, while leaders from CVS Caremark, Express Scripts and Optum Rx all countered that the sector in fact lowers prices and supports local pharmacies.
    • “The hearing accompanied the committee’s release of a report detailing what its investigators characterized as abuses by the three large companies.”
  • Govexec lets us know,
    • “A federal employee group within the Justice Department last week made its final pitch to the federal government’s dedicated HR agency to boost the federal government’s coverage of in vitro fertilization and other assisted reproductive technology through the Federal Employees Health Benefits Program.
    • “The Department of Justice Gender Equality Network, an employee association representing nearly 2,000 workers at the Justice Department, sent acting Office of Personnel Management Director Rob Shriver three dozen testimonials from members describing the hardships they endured while trying to conceive. The move comes amid OPM’s final round of negotiations with insurance carriers over what FEHBP plans will cover next year.”
  • Federal News Network tells us,
    • “More than 15 years in the making, plans to update the federal pay system for blue-collar government employees are finally gaining some traction.
    • “A proposal to reform the Federal Wage System (FWS) has moved into the early stages of the government’s rulemaking process, the Federal Prevailing Rate Advisory Committee (FPRAC) announced during a public meeting Thursday morning.
    • “The proposal, if finalized, would amend the federal pay system for blue-collar government workers, more closely aligning it with the locality pay areas for the General Schedule (GS). An estimated 15,000 blue-collar feds would see their pay rates increase.”
  • Fierce Healthcare informs us,
    • “Walgreens has received $25 million in grant funding to conduct a decentralized clinical trial assessing how well a person vaccinated against COVID-19 is protected from future infections. 
    • “The award funding comes from a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), embedded in the U.S. Department of Health and Human Services. The partnership is BARDA’s first with a major retail pharmacy. Walgreens will conduct a phase IV observational clinical study, using COVID vaccine data, to assess correlates of protection, known as responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data.
    • “The initiative’s goal is to increase access to clinical trials. Currently, participants in a vaccine clinical trial often travel to hospitals, universities or other central locations that are far from their homes. Taking a decentralized approach through a geographically diverse retailer like Walgreens can help reach patients where they are and enable the collection of real-world data, the organizations said. The partners also hope that learning what aspects of decentralized clinical trials work for vaccine correlates of protection studies can help drive future studies at scale.”
  • The Office of National Coordinator for Health Information Technology issued a standards bulletin that is “a companion to the USCDI v5 standard document published in July 2024. This issue provides background of USCDI v5 and the new data classes and elements that support improved patient care and advance the Administration’s goals of equity, diversity, and access to health care.”
  • The Food and Drug Administration announced,
    • On Monday, [July 22,] the FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
    • “Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”
    • The most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. See full prescribing information for additional information on the safety and effectiveness of Femlyv.

From the public health and medical research front,

  • The American Hospital Association News relates,
    • “The Department of Health and Human Services July 23 released an amendment to a 2013 emergency declaration under the Food, Drug and Cosmetic Act that broadens the scope in which the agency can help facilitate certain medical countermeasures in response to a public health emergency such as a pandemic. The amendment now applies to pandemic influenza A viruses and others with pandemic potential, such as the current H5N1 strain of bird flu that has infected cattle and subsequently humans in some states. Previously, the declaration specifically covered just the H7N9 strain of bird flu. The declaration would allow the Food and Drug Administration to extend the expiration date of certain medical products and allow HHS to issue an emergency use authorization for unapproved drugs, devices or products, among other actions.”
  • Per BioPharma Dive,
    • “An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded in a late-stage trial, the company said Tuesday.
    • “In a statement, Merck said the therapy, an antibody called clesrovimab, met its main safety and efficacy objectives in a placebo-controlled trial involving more than 3,600 healthy or preterm infants. Those goals included the incidence of RSV-associated lower respiratory infections requiring medical attention over the course of five months, compared to placebo, as well as the percentage of patients experiencing certain types of adverse events.
    • “A spokesperson told BioPharma Dive in an email that clesrovimab met a key secondary measure by reducing the risk of hospitalization from RSV in the trial. But the company didn’t provide specifics on that result or the rest of the study findings, which will be presented at a future medical meeting. In the meantime, Merck plans to share the data with global health authorities.”
  • Per National Institutes of Health press releases,
    • “Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
    • “Cisgender women experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during pregnancy and the postnatal period, and we need to offer them evidence-based options when they may need them most,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy.”
  • and
    • “A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive. The findings were presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
    • “We are still learning how to optimize the package of services that accompany long-acting PrEP, including HIV testing,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “The viral load testing findings observed in this study illuminate performance gaps in the current U.S. HIV testing algorithm for injectable cabotegravir PrEP.”
  • and
    • “Researchers at the National Institutes of Health (NIH) found that an artificial intelligence (AI) model solved medical quiz questions—designed to test health professionals’ ability to diagnose patients based on clinical images and a brief text summary—with high accuracy. However, physician-graders found the AI model made mistakes when describing images and explaining how its decision-making led to the correct answer. The findings, which shed light on AI’s potential in the clinical setting, were published in npj Digital Medicine.  The study was led by researchers from NIH’s National Library of Medicine (NLM) and Weill Cornell Medicine, New York City.
    • “Integration of AI into health care holds great promise as a tool to help medical professionals diagnose patients faster, allowing them to start treatment sooner,” said NLM Acting Director, Stephen Sherry, Ph.D. “However, as this study shows, AI is not advanced enough yet to replace human experience, which is crucial for accurate diagnosis.”
  • Per MedPage Today,
    • “Patients with dementia may instead have hepatic encephalopathy (HE) and should be screened with the Fibrosis-4 (FIB-4) index for cirrhosis, one of the main causes of the condition, new research suggests.
    • “The study of more than 68,000 individuals in the general population diagnosed with dementia between 2009 and 2019 found that almost 13% had FIB-4 scores indicative of cirrhosis and potential HE.
    • “The findings, recently published online in The American Journal of Medicine, corroborate and extend the researchers’ previous work, which showed that about 10% of US veterans with a dementia diagnosis may in fact have HE.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “HCA Healthcare reported second-quarter earnings that handily beat Wall Street expectations.
    • “The Nashville, Tennessee-based operator posted $17.5 billion in revenue, a net income of $1.5 billion and a 5.8% increase in same facility admissions. During a call Tuesday, HCA’s executive team attributed the company’s success to broad demand for services and an ability to manage expenses.
    • “HCA updated its full-year revenue guidance following the results. It now expects to draw between $69.8 billion and $71.8 billion, up from the originally forecast $67.8 billion to $70.3 billion.”
  • Modern Health points out,
    • “Molina Healthcare said Tuesday it is expanding into Connecticut through an agreement to acquire EmblemHealth subsidiary ConnectiCare Holding Co., for $350 million.
    • “The Farmington, Connecticut-based health insurer has approximately 140,000 members in marketplace, Medicare and other health insurance plans across the state, according to a news release. Molina said the purchase price represents a quarter of ConnectiCare’s $1.4 billion in expected 2024 revenue. The company said it will fund the deal with cash on hand and plans to close it in the first half of 2025.
    • “The ConnectiCare purchase is part of Long Beach, California-based Molina’s strategy to develop stable revenue streams and deploy capital more efficiently, President and CEO Joe Zubretsky said in the news release.
    • “The deal is Molina’s second acquisition this year. In January it completed the purchase of Bright Health Group’s California Medicare Advantage business for $425 million.”
  • Beckers Hospital Review identifies fifteen health systems that are dropping certain Medicare Advantage plans and notes,
    • Medicare Advantage accounted for around 1 in 4 inpatient hospitals days in 2022, according to a report from KFF published July 23.  * * *
    • In rural and micropolitan counties, the share of inpatient days from Medicare Advantage enrollees doubled between 2015 and 2022. 
    • Read more here. 
  • Behavioral Health Business discusses virtual applied behavioral therapy.
    • “It’s no secret that there is a steep supply-and-demand issue for applied behavior analysis (ABA) services nationwide. 
    • “The industry is relatively new, which means the pool of qualified professionals is still small compared to the need. There are less than70,000 board-certified behavior analysts in the U.S. Still, autism impacts 1 in 36 children, according to the CDC. 
    • “Many of those qualified clinicians are prioritizing flexibility in the workplace and turning to telehealth.”

Monday Roundup

David Ermer–ACA, CDC, CMS, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Healthcare Dive reports,
    • “The Biden administration is making it harder for insurance agents and brokers to change people’s plans on the federal Affordable Care Act marketplace following mounting consumer complaints about unauthorized changes.
    • “On Friday, the CMS announced agents can’t make changes to a consumer’s enrollment in the federal exchanges unless they’re already associated with that consumer. If agents and brokers are unassociated, they have to take additional steps to update a consumer’s marketplace enrollment — even with that consumer’s consent, according to the notice.
    • “Unassociated brokers will have to have a three-way call with the beneficiary and the marketplace’s call center, or have the beneficiary change their enrollment themselves through HealthCare.gov or another approved portal. The changes, which don’t apply to the 18 states (and Washington, D.C.) that run their own insurance marketplaces, took effect immediately.”
  • Per an HHS press release,
    • “The Biden-Harris Administration’s Kids Online Health and Safety Task Force, co-led by the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Commerce’s (DOC) National Telecommunications and Information Administration (NTIA), released a new report today with recommendations and best practices for safer social media and online platform use for youth. The recommendations in the report, Online Health and Safety for Children and Youth: Best Practices for Families and Guidance for Industry, underscore the Administration’s efforts to address the ongoing youth mental health crisis and support the President’s Unity Agenda for the nation. Task Force members also committed to future actions, including providing more resources for kids, teenagers and families, guidance for pediatricians and conducting more research.”
  • Healthcare Innovation lets us know,
    • “On July 17, the Office of the National Coordinator for Health IT (ONC) released the agency’s latest Data Brief and Quick Stat. According to ONC’s survey findings, 64 percent of U.S. hospitals plan to participate in TEFCA™, the Trusted Exchange Framework and Common Agreement. The agency notes that “This is an increase over 2022, when 51 percent of U.S. hospitals said they planned to participate.”
    • “Other findings:
      • “Approximately 7 out of 10 hospitals that participated in national networks or health information exchanges (HIEs) planned to participate in TEFCA, compared to 4 out of 10 hospitals that did not participate in either type of network.
      • “Hospitals with more resources, such as those that are larger, non-critical access, and affiliated with health systems, indicated greater awareness and had higher levels of planned participation in TEFCA when compared to smaller, critical access, and independent hospitals with fewer resources.
      • “The percent of hospitals that were aware of TEFCA but did not know if they would participate decreased from 23% to 9% from 2022 to 2023.”
    • FEHBlog Note — TEFCA is the government’s backbone for the healthcare electronic medical records system.

From the public health and medical research front,

  • The Washington Post reports,
    • “More than 40 percent of women said they skipped or delayed a screening recommended by a health professional, according to a recent survey by Gallup for the medical technology company Hologic.
    • “In the survey of 4,001 adult women across the United States, 90 percent of respondents agreed that it is important to get regular preventive health screenings for cancer, heart disease, sexually transmitted infections and other key health conditions. But 43 percent also said they skipped or delayed a recommended screening, including for breast cancer, cervical cancer and colorectal cancer.
    • “The respondents cited multiple reasons for doing so: anxiety about medical tests, pain concerns, cost, lack of time or not believing a screening was necessary.
    • “In addition, only 42 percent of the participants said they were “very confident” about which health screenings they needed. Many women also had trouble finding pertinent information, with 31 percent of Gen Z women saying it was hard for them to find relevant health information.”
  • Medscape tells us,
    • “Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.
    • “A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.” * * *
    • “Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” said Millennium Health Chief Clinical Officer Angela Huskey, PharmD, in a press release.”

From the U.S. healthcare business front,

  • Fierce Healthcare names the most influential minority executives in healthcare. Kudos to that group.
  • Beckers Payer Issues points out recent physician hires to executive roles at payer organizations.
  • Fierce Healthcare informs us,
    • “Embattled Steward Health Care has canceled auctions for its hospitals in Ohio and Pennsylvania after it did not receive qualified bids for those facilities, according to a court filing.
    • “The health system said in a document filed Sunday with bankruptcy court in Texas that it is working to determine alternatives for those facilities and expects to make an announcement at a later date. It had initially set a bid deadline for June 24 for these assets, which was later pushed back to July 15.
    • “Steward filed for chapter 11 bankruptcy in the Southern District of Texas in May.”
  • Fierce Healthcare also relates,
    • “Cigna has created a new impact fund that aims to address health disparities commonly impacting local communities.
    • “The insurer’s philanthropic arm, the Cigna Group Foundation, will operate the Cigna Group Health Equity Impact Fund. Through the program, Cigna will contribute $9 million over the next three years to tackle disparities and inequities across priority states.
    • “According to an announcement, the program will initially focus in Houston, Texas and Hartford, Connecticut. By drilling down to these specific communities, Cigna said it can “optimize” the level of assistance needed to put toward the unique equity challenges they’re facing.”

Thursday Miscellany

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

From Washington, DC,

  • Modern Healthcare reports,
    • “A powerful Senate committee plans to commence a bipartisan investigation into the Steward Health Care meltdown next week.
    • “The Senate, Health, Education, Labor and Pensions Committee will convene next Thursday for a vote to officially kick off a probe into the insolvent Dallas-based health system. Steward Health Care Chair and CEO Dr. Ralph de la Torre will be subpoenaed to testify at a hearing Sept. 12, HELP Committee Chair Bernie Sanders (I-Vt.) and ranking member Dr. Bill Cassidy (R-La.) said in a news release Thursday.
    • “Given the serious harm and uncertainty Steward’s bankruptcy and financial arrangements are having on hospitals, patients and healthcare workers throughout the country, Dr. de la Torre has given us no choice but to compel him to testify at this hearing,” Sanders and Cassidy said.
    • “De la Torre declined to attend a HELP Committee hearing last month and a subcommittee session in April.
    • “We have a number of questions to ask Dr. de la Torre about the bankruptcy of Steward Health Care and the financial arrangements leading up to its insolvency. It is time for Dr. de la Torre to answer them before Congress and the American people,” Sanders and Cassidy said.
  • Federal News Network informs us,
    • “The Office of Personnel Management will soon be reopening enrollments into the government’s Flexible Spending Account program, FSAFEDS.
    • “OPM previously suspended all new enrollments in the program after a recent surge in fraudulent activity that impacted hundreds of federal employees with Flexible Spending Accounts. OPM’s inspector general said the suspension came “out of an abundance of caution,” and to try to prevent further fraud in the program.
    • “Enrollments in FSAFEDS, including any enrollments based on Qualifying Life Events (QLEs), will reopen Aug. 1, OPM wrote in an email to agency benefit officers Thursday afternoon, shared with Federal News Network. Also beginning Aug. 1, the program will transition to a “.gov” website domain, FSAFEDS.gov, rather than the current domain, FSAFEDS.com.
    • “Enrollees who missed a QLE deadline due to the pause on enrollments should still be able to make modifications once the enrollment pause is lifted, OPM said. Employees who are in that situation will have to call FSAFEDS at 877-372-3337 to request a change to the effective date for the QLE.
    • “Additionally, federal employees will be able to get reimbursed for any claims that were incurred after the effective date for the QLE, OPM said.
    • “OPM is also taking more long-term steps to address security concerns in FSAFEDS, including transitioning to Login.gov, the government’s platform for accessing government benefits and services online.”
  • Per Govexec,
    • “The Office of Personnel Management wants federal agencies to let it know how many senior executives, scientific/professionals and other senior-level personnel they estimate they will need for the next two years.
    • “OPM outlined its biennial review of agency executive allocations in a July 10 memorandum, calling on agency and department heads to examine their potential Senior Executive Service needs through fiscal 2026 and 2027 and how they may have changed. 
    • “The biennial review, which is required by statute, will give agencies until Nov. 22 to fully outline their anticipated SES needs, but they must also detail the projections of their position needs in their Senior Level and Scientific/Professional pay systems by Aug. 23. 

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “The highest numbers of breast and cervical cancer deaths are found mostly in southeastern states, according to new data from the “2024 State Scorecard on Women’s Health and Reproductive Care” released July 18 by The Commonwealth Fund.
    • “The analysis is based on 2021-22 data from publicly available sources. Learn more about the methodology here.
    • “Alabama, Arkansas, Delaware, the District of Columbia, Indiana, Kentucky, Louisiana, Mississippi, Missouri, Nevada, Oklahoma, Tennessee and West Virginia had 23.2 to 27.8 breast and cervical cancer deaths per 100,000 female population, the highest numbers in the country.”
  • The NIH Director, in her weekly blog, lets us know,
    • “Alzheimer’s disease is currently the seventh leading cause of death in the U.S. While your likelihood of developing Alzheimer’s-related cognitive impairment increases with age, risk for this disease and age of its onset depend on many factors, including the genes you carry. An intriguing new study suggests that having just one copy of a protective gene variant may be enough to delay cognitive impairment from this devastating disease in individuals who are otherwise genetically predisposed to developing early-onset Alzheimer’s dementia.
    • “The findings, from a study supported in part by NIH and reported in The New England Journal of Medicine, offer important insights into the genetic factors and underlying pathways involved in Alzheimer’s dementia. While much more study is needed, the findings have potential implications for treatments that could one day work like this gene variant does to delay or perhaps even prevent Alzheimer’s dementia.”
  • The Washington Post reports,
    • “If you want to increase your odds of living a long and healthy life, watch less television and become more physically active, because even a small amount of physical activity can improve overall health, according to an observational study published last month in JAMA Network Open.
    • “While there have been many studies showing that moderate to vigorous physical activity is associated with healthy aging, researchers wanted to know if light physical activity compared with sedentary behaviors also improves healthy aging, and if not, how can people’s time be reallocated.
    • “They found that replacing a sedentary behavior such as watching TV with even low-intensity activity — such as standing or walking around while cooking or washing clothes — increased one’s odds of healthy aging. And at work, replacing some of the time spent sitting with simple movements such as standing or walking around the office can improve health.
    • “These findings indicate that physical activity need not be high intensity to potentially benefit various aspects of health, which have especially important public health implications as older people tend to have limited physical ability to engage in moderate-to-vigorous physical activity,” Molin Wang, an associate professor in epidemiology at the Harvard T.H. Chan School of Public Health and an author of the study, wrote in an email.”
  • Per Medscape,
    • “An analysis based on a massive database of US electronic health records (EHRs) adds to evidence favoring the safety of glucagon-like peptide 1 (GLP-1) medications, finding no increased risk for many neurologic and psychiatric ailments when semaglutide was compared with other diabetes drugs.
    • “Riccardo De Giorgi, MD, DPhil, of the University of Oxford, Oxford, England, and colleagues published their research in eClinicalMedicine.”
  • Bloomberg informs us,
    • “Opioids. They’re a public-health pariah, leading to more than 80,000 overdose deaths a year. Patients worry they’ll get addicted to them. Doctors want nothing to do with them. And politicians of all stripes are calling for less dangerous options for treating pain.
    • “We are looking for absolutely anything that’s not an opioid,” says Seth Waldman, an anesthesiologist and director of pain management at Hospital for Special Surgery, a top orthopedic medicine center.
    • “Against that backdrop, the success of a safer painkiller would seem assured. A new drug, which Vertex Pharmaceuticals Inc. is developing, has been hailed as a scientific breakthrough because it treats pain without entering the brain, where opioids create addicts. The drug, suzetrigine, met its goal this year in pivotal trials for acute pain and is poised to become the first new class of pain medication in more than two decades.
    • “But all that may not be enough to loosen the grip opioids have on American medicine. Despite their dismal reputation, they have two powerful things going for them: They’re cheap, and they work. The number of opioid prescriptions has been cut by half over the past decade, but some 130 million are still doled out each year.” * * *
    • “Vertex is betting the nonaddictive properties of its drug will make it an attractive alternative to opioids. But it isn’t leaving anything to chance. Knowing it faces an uphill battle commercially, the company last year boosted its lobbying spending almost 50%, to more than $3 million. Vertex is pressing Congress for new policies that remove “structural impediments” blocking access to opioid alternatives, says Stuart Arbuckle, its chief operating officer.
    • “Vertex has scored at least one legislative victory: The No Pain Act, which goes into effect next year, provides an extra Medicare reimbursement to hospitals that prescribe alternatives to opioids. Another bill introduced this year in Congress would prohibit step therapy and limit how much Medicare patients pay out of pocket for non-opioids.
    • “Other types of new drugs face this cost hurdle, too. The rollout of new contraceptives or antibiotics has been hampered by insurers guiding doctors and patients to older, less pricey meds. The difference is that those generics haven’t been declared a public-health emergency.”
  • Mercer Consulting points out “four things employers need to know about summer heat.”
  • The New York Times reports,
    • “A daily dose of a widely used antibiotic [doxycycline] can prevent some infections with syphilis, gonorrhea and chlamydia, potentially a new solution to the escalating crisis of sexually transmitted infections, scientists reported on Thursday.
    • “Their study was small and must be confirmed by more research. Scientists still have to resolve significant questions, including whether S.T.I.s might become resistant to the antibiotic and what effect it could have on healthy gut bacteria in people taking it every day.
    • “The approach would be recommended primarily to people at elevated risk of sexually transmitted infections during certain periods, said Dr. Jeffrey Klausner, an infectious diseases physician at the University of Southern California who was not involved in the new work.
    • “The number of people who are really going to be offered this and take this is still very small,” he said. “In general, the more choices we have for people, the more prevention options we have, the better.”

From the U.S. healthcare business front,

  • Per Fierce Pharma,
    • “GoodRx is joining forces with drugmaker Boehringer Ingelheim to make its Humira biosimilar adalimumab available at an affordable price.
    • “The pharmaceutical company will offer citrate-free adalimumab-admb at a cash price available only on GoodRx, according to an announcement. This will allow anyone with a prescription to obtain the drug at one of 70,000 pharmacies nationwide, even if they’re uninsured.
    • “Beginning on July 18, Boehringer and GoodRx will offer high-concentration and low-concentration formulas of the drug in auto-injectors or pre-filled syringes at a price of $550 per two pack. The companies said that this is a 92% discount compared to a Humira prescription.”
  • Per Beckers Hospital Review,
    • “The FDA is allowing Mark Cuban Cost Plus Drug Co. to temporarily import a syphilis drug that has been in shortage for more than a year. 
    • “Penicillin G benzathine injection fell into low supply in April 2023, and since then, clinicians have been rationing the product. In January, the FDA issued a temporary authorization for French drugmaker Laboratoires Delbert to import penicillin G benzathine. 
    • “On July 17, the FDA updated its post on the drug’s shortage. To address the scarcity, the agency cleared Cost Plus Drugs to import the medication from Laboratórios Atral.
    • “The Portugal-based drug company will export two presentations of Lentocilin (benzathine benzylpenicillin tetrahydrate), according to FDA documents.
    • “Cost Plus Drugs is selling this medication to healthcare businesses for less than $15, the company said in July 17 post on X.” 
  • Segal Consulting relates,
    • “The average stop-loss coverage premium increase is 9.4 percent for the nearly 240 health plans in Segal’s 2024 national medical stop-loss dataset.”
    • “The average includes groups that increased specific stop-loss deductible levels and/or aggregating specific stop-loss deductibles resulting in an overall reduced rate action. The average premium increase for groups that maintained similar specific stop-loss benefit levels as the prior year is 11.5 percent.”
  • Per Fierce Healthcare,
    • “Telehealth giant Teladoc is partnering with startup Brightline to extend virtual mental healthcare services for children, adolescents and their families.
    • “Through the partnership, members under the age of 18 will have access to Brightline’s behavioral health solutions through Teladoc’s virtual “front door,” the companies said.
    • “The collaboration with Brightline builds on Teladoc’s existing mental health offerings and expands access to care to members of all ages, a Teladoc spokesperson said.”
  • Beckers Hospital Review identifies seven U.S. hospitals that have received brain tumor care certification by the Joint Commission.
    • Chippenham and Johnston-Willis Hospital, Richmond, VA
    • Hackensack (N.J.) University Medical Center Hackensack
    • Jewish Hospital, Cincinnati, OH
    • Pitt County Memorial Hospital, Greenville, N.C.
    • Santa Barbara (Calif.) Cottage Hospital
    • St. Vincent Hospital and Health Care Services, Indianapolis, IN
    • Texas Health Harris Methodist Hospital – Fort Worth, TX
  • Healthcare Dive lets us know,
    • “Humana has made a minority investment in Healthpilot, a company that aims to help beneficiaries choose Medicare plans, the insurer said Wednesday. Financial terms of the deal weren’t disclosed.
    • “Healthpilot uses an artificial intelligence model to recommend Medicare Advantage, Medicare supplement and prescription drug plans based on enrollee information.
    • “Healthpilot will continue to recommend plans options from other payers following the investment, Humana said in the release. 

Midweek Update

David Ermer–AHRQ, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal adds,
    • “A summer Covid wave is hitting the country, but there’s one consolation: Your chances of developing long Covid have fallen since the start of the pandemic. 
    • “That’s the finding from a new study in the New England Journal of Medicine. It concluded that about 10% of people infected with the virus’s original strain developed long Covid. By contrast, the risk of developing long Covid dropped to 3.5% with the virus’s Omicron variant among vaccinated people. For the unvaccinated, the risk was 7.7.%.
    • “Researchers defined long Covid as people who experienced persistent and debilitating symptoms such as a racing heartbeat or brain fog, or other new health problems linked to the initial illness, a month or more after their infection.
    • “About 70% of the drop in long Covid cases was due to vaccination and 30% because of changes in the virus itself, the study determined. 
    • “Four years since the start of the pandemic, we’re getting used to periodic waves of Covid cases, including the uptick we’re seeing now, driven by Omicron subvariants. The threats of severe illness and lingering health problems have significantly subsided, though they haven’t disappeared.”
  • Beckers Hospital Review reports,
    • “As the House Committee on Oversight and Accountability investigates pharmacy benefit managers regarding alleged anticompetitive practices, the committee scheduled a hearing with leaders of the top three PBMs. 
    • “On July 23, [at 10 am ET], members of the House Committee on Oversight and Accountability plan to ask executives at Express Scripts/Evernorth, CVS Caremark and OptumRx about the alleged anticompetitive policies, which committee members say raise prescription drug costs, harm independent pharmacies and obstruct patient care. 
    • “The three PBMs account for about 80% of the market share. 
    • “The called witnesses are Adam Kautzner, PharmD, president of Evernorth Care Management and Express Scripts; David Joyner, executive vice president of CVS Health and president of CVS Caremark; and Patrick Conway, MD, CEO of OptumRx.”
  • The FEHBlog discovered today that on July 11, 2024, Rep. Gary Palmer (R Ala.) introduced House Jt. Resolution 187 which reads,
    • “Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That Congress disapproves the rule submitted by the Office of Personnel Management relating to Postal Service Reform Act; Establishment of the Postal Service Health Benefits Program (89 Fed. Reg. 37061), and such rule shall have no force or effect.”
  • The cited rule is the OPM’s May 2024 supplemental rule implementing the PSHBP. In the FEHBlog’s opinion, the provision of the rule which offends Rep. Palmer (and the FEHBlog) for that matter is found in an OPM FAQ:
    • “While the proposed rule reflects that Medicare Part D-eligible annuitants and their Part D-eligible family members would be automatically group enrolled into the Part D EGWP, it reflects that they may choose to opt out of receiving prescription drug coverage through the PSHB Part D EGWP. This proposed rule provides, consistent with the statute, that the Part D EGWP offered by their PSHB plan is the only PSHB prescription drug benefit available for Part D-eligible PSHB annuitants and their Part D-eligible covered family members. As proposed, Medicare Part D-eligible annuitants and their family members who choose to opt out of or disenroll from the PSHB plan’s Part D EGWP would not have access to prescription drug benefits through their PSHB plan and would not pay a lower premium than those enrolled in the Part D EGWP.“
  • Nothing in the Postal Service Reform Act suggests that Congress intended to impose such a penalty. It’s a penalty because OPM does not reduce the premium for members who are deprived of their plan’s prescription drug benefits. Furthermore, when Congress included a mandate for PSHBP annuitants to enroll in Part B, it also provided grandfathering protections and exemptions. The Part D penalty applies across the board.
  • In any case, because Part D benefits will feature improvements such as a $2,000 out of pocket cost maximum for 2025, the carrot approach to incenting Part D EGWP enrollment should be tried first.
  • The American Hospital Association News lets us know,
    • “The Administration for Strategic Preparedness and Response July 16 announced it will work with the Department of Commerce on an assessment of the active pharmaceutical industrial base to better understand the pharmaceutical supply chain and how it has changed since the COVID-19 pandemic. The assessment is based on a survey conducted last winter. The study will inform federal strategies and funding decisions related to the API supply chain and raise awareness of potential supply chain issues, such as the current limited domestic manufacturing capabilities and other potential issues. The study will survey more than 200 companies, including manufacturers, distributors, suppliers and customers. A Bureau of Industry and Security webpage answers FAQs about the project.”

From the public health and medical research front,

  • STAT News tells us,
    • “The Centers for Disease Control and Prevention just released a trove of data on Americans with disabilities that found that more than a quarter of U.S. adults have a disability — over 70 million people, a bump from prior years. This slice of the population was also much more likely to report long Covid symptoms such as chronic fatigue and brain fog. This comorbidity looms large for many disabled communities as another surge in Covid cases sweeps the country.
    • “The data, gathered in 2022, is part of the agency’s Disability and Health Data System, which has annual state and national-level data stretching back to 2016. This is the first year that the agency has released long Covid data, finding that 11% of people with disabilities had long Covid symptoms while only 7% of people without disabilities reported symptoms.
    • “For many disabilities, the highest populations exist in a swath that extends from the Deep South and Louisiana up to Appalachian communities in West Virginia and Ohio. Disability benefits claims are typically highest in these areas, but for long Covid, the geography shifted west. Idaho and other states along the Continental Divide saw much higher rates of symptoms, with Montana recording the highest prevalence at 18%.”
  • The New York Times adds,
    • “A large new study provides some of the strongest evidence yet that vaccines reduce the risk of developing long Covid.
    • “Scientists looked at people in the United States infected during the first two years of the pandemic and found that the percentage of vaccinated people who developed long Covid was much lower than the percentage of unvaccinated people who did. 
    • “Medical experts have previously said that vaccines can lower the risk of long Covid, largely because they help prevent severe illness during the infection period and people with severe infections are more likely to have long-term symptoms.
    • “But many individuals with mild infections also develop long Covid, and the study, published Wednesday in The New England Journal of Medicine, found that vaccination did not eliminate all risk of developing the condition, which continues to affect millions in the United States.”
  • STAT News also informs us,
    • “A study published Wednesday in the Journal of Clinical Oncology found that certain unmatched donors, or people whose bone marrow does not as closely resemble that of the patient’s, provided similar outcomes to matched donors so long as patients receive a key drug called cyclophosphamide to prevent dangerous complications. That suggests that patients who need a transplant might be able to safely consider both matched and some unmatched donors, vastly expanding the pool of potential acceptable donors for all patients, though particularly those of African, Latino, or Asian ancestry.
    • “It’s much harder to find a match for most of my patients. Looking to people who are donor unrelated and aren’t a perfect match for my patients has become the norm,” said Sekeres, who is the chief of hematology at Sylvester Cancer Center at the University of Miami and did not work on the study. “That’s why this study really resonated with me. The classic teaching is you want a perfect match as opposed to less than perfect. What this study suggests is, if you use the right drugs after transplant, it may not be as big of a deal.”
    • “If so, up to roughly 84% of African American patients might have a potential donor in the national registry. Currently, less than 30% of African American patients have a potential match in the NMDP registry, previously called the National Marrow Donor Program.”
  • Per BioPharma Dive,
    • “A closely watched obesity pill being developed by Roche helped people in a small Phase 1 trial lose 7.3% of their body weight over four weeks when taken once daily — 6.1 percentage points more than those given a placebo, the company said Wednesday.
    • “The data comes two months after the Swiss drugmaker disclosed trial results from another obesity drug in its pipeline, which showed the once-weekly injection helped reduce body weight by 19% over six months. Roche disclosed more detailed data for that drug, indicating none of the trial participants stopped taking it due to side effects — a reason users might quit taking Wegovy or Zepbound.
    • “The two drugs came from Roche’s $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to enter a market estimated to be worth more than $100 billion annually by early next decade.”
  • Beckers Hospital Review interviews NYU Langone’s bariatric surgery chief about the first GLP-1 generic and other GLP-1 issues.
  • Per a National Institutes of Health press release,
    • “A neuroimaging study of young people who exhibit a persistent pattern of disruptive, aggressive, and antisocial behavior, known as conduct disorder, has revealed extensive changes in brain structure. The most pronounced difference was a smaller area of the brain’s outer layer, known as the cerebral cortex, which is critical for many aspects of behavior, cognition and emotion. The study, co-authored by researchers at the National Institutes of Health (NIH), is published in The Lancet Psychiatry.
    • “Conduct disorder has among the highest burden of any mental disorder in youth. However, it remains understudied and undertreated. Understanding brain differences associated with the disorder takes us one step closer to developing more effective approaches to diagnosis and treatment, with the ultimate aim of improving long-term outcomes for children and their families,” said co-author Daniel Pine, M.D., chief of the Section on Development and Affective Neuroscience in NIH’s National Institute of Mental Health. “Critical next steps are to follow children over time to determine if differences in brain structure seen in this study are a cause of conduct disorder or a long-term consequence of living with the disorder.”
  • The National Cancer Institute posted its latest cancer information highlights.
  • The Institute of Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of acoramidis (BridgeBio Pharma, Inc.), tafamidis (Vyndamax®/Vyndaqel®, Pfizer Inc.), and vutrisiran (Amvuttra®, Alnylam Pharmaceuticals, Inc.) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).”
  • AHRQ’s Patient Safety Network informs us,
    • “Patients presenting to the emergency department (ED) are triaged to prioritize care based on level of illness. In this study, 2,543 patients presenting to an ED in Switzerland were asked to self-triage using an electronic symptom-checker. (Patients were triaged and treated based on standard-of-care nurse triage.) Recommendations were given regarding time to treat (e.g., emergency) and point-of-care (e.g., self-care) and subsequently evaluated by three panels of experts. Fifty of the 2,543 patients were judged as undertriaged, but none were judged as potentially hazardous.”

From the U.S. healthcare front,

  • Healthcare Dive points out,
    • “Elevance reported solid second-quarter results on Wednesday — including $2.3 billion in profit — but the company still lowered long-term revenue growth guidance for its health insurance business. That disconnect raised red flags for analysts.”
    • “Changing revenue growth forecasts for health benefits in the middle of the year “is unusual,” commented Jefferies analyst David Windley in a Wednesday note. “We can’t identify a single, large item that would compel [the reduction] off-cycle.”
    • “During a call with investors Wednesday, Elevance management cited several factors for dropping the guidance, including significant member losses from Medicaid redeterminations and Medicare Advantage bids for 2025 that could slow growth.”
  • Fierce Pharma reports,
    • “As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations.”
    • “While J&J is “not in alignment” with IRA or its price setting process, the company has accepted the reality of the situation and baked assumptions about the future costs of its drugs into its growth projections through the end of the decade, Jennifer Taubert, EVP, worldwide chairman, innovative medicine at J&J, said on an analyst call Wednesday.
    • “As it stands, J&J currently expects to grow its business by 3% next year and then 5% to 7% out through 2030, Taubert said.”
  • Per Fierce Healthcare,
    • “Electronic health record messages to patients drafted by generative AI were of similar quality and accuracy to those written by healthcare professionals, according to a newly published study conducted using queries from NYU Langone Health patients.”
    • “The analysis, headed by researchers at the system’s affiliate NYU Grossman School of Medicine, had 16 primary care physicians rate AI and human drafts without knowing how each was written.
    • “Among a sample of 334 AI-drafted messages and 169 from professionals (both physicians and non-physicians), the raters found both sets to be on par regarding informational content, completeness and whether the grader would use the draft or start again from scratch.”
    • “The findings “suggest chatbots could reduce the workload of care providers by enabling efficient and empathetic responses to patients’ concerns,” study lead William Small, M.D., of the medical school, said in a release.”

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, NIH, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fierce Healthcare tells us
    • “A bipartisan quartet of House representatives have introduced a bill peeling back restrictions on new or expanded physician-owned hospitals.
    • “The Physician Led and Rural Access to Quality Care Act, brought late last week, would create an exception to an Affordable Care Act’s ban that aimed to reduce conflicts of interest in care. Specifically, it would permit new physician-owned hospitals to open in rural areas that are at least 35 miles from another existing hospital or critical access hospital (or 15 miles in difficult-to-traverse areas).
    • “The new bill would also sunset a prohibition on expanding any existing physician-owned hospitals.”
    • FEHBlog note: The bill pits the American Medical Association (pro) against the American Medical Association (con).
  • Per a Department of Health and Human Services press release,
    • “Today, CMS is releasing the final part two guidance – PDF regarding plan outreach and education for the Medicare Prescription Payment Plan, which aims to ensure that people with Medicare prescription drug coverage, especially those most likely to benefit, are aware of the payment option. Starting in 2025, the Medicare Prescription Payment Plan provides the option to people with Medicare prescription drug coverage to spread the costs of their prescription drugs over the calendar year rather than paying in full at the pharmacy counter each time they fill a prescription. People with Medicare must opt into the Medicare Prescription Payment Plan to utilize the new benefit. Notably, this payment option launches at the same time that all individuals with Medicare prescription drug coverage will begin to have their annual out-of-pocket prescription drug costs capped at $2,000, providing needed financial relief for high prescription drug costs.” * * *
    • “Today’s Medicare Prescription Payment Plan final part two guidance, which complements the final part one guidance – PDF released on February 29, is also accompanied by the release of the final Medicare Prescription Payment Plan model materials. Medicare Part D plans can use the model materials when communicating to Part D enrollees about the Medicare Prescription Payment Plan.” * * *
    • “For the fact sheet on the final part two guidance for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/fact-sheet-medicare-prescription-payment-plan-final-part-two-guidance.pdf – PDF
    • “For the updated Information Collection Request (ICR) for the Medicare Prescription Payment Plan model plan materials, please visit: https://www.cms.gov/files/zip/medicare-prescription-payment-plan-model-materials.zip
    • “For an updated implementation timeline for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/medicare-prescription-payment-plan-timeline.pdf – PDF“
  • Another HHS press release brings us up to date on improvements to the 988 mental health lifeline which was launched two years ago today.
  • Healio adds,
    • “Since the launch of the 988 Suicide & Crisis Lifeline in 2022, counselors have answered more than 10 million calls, texts and chats from people seeking help for suicidal thoughts and mental health crises, according to HHS officials.
    • “During a press conference, HHS Deputy Secretary Andrea Palm said the lifeline “has become one of the most effective first-line responses that we have to help individuals who feel alone and without options.” * * *
    • “HHS has invested nearly $1.5 billion into the lifeline, according to an agency press release. It has lines that are tailored to people who speak Spanish, veterans, American Sign Language (ASL) users and the LGBTQI+ community. Since these lines were added to the 988 lifeline in 2023, there have been about 20,000 chats and texts with Spanish speakers, more than 475,000 texts, calls and chats with LGBTQI+ individuals and approximately 20,000 videophone contacts with ASL users.
    • “Among all contacts over the past 2 years, about 1.7 million were texts, according to the release. In the past year, HHS reported a 51% increase in texts and a 34% increase in calls, with support provided by more than 200 contact centers nationwide.”
  • CMS shares the following statement from CMS Administrator Chiquita Brooks-LaSure:
    • “Remembering Gail R. Wilensky, Ph.D., a health care policy savant who knew how to work across the aisle. Her Influence and leadership can still be felt today. She was very generous to the CMS leaders who served after her, including me. My deepest condolences to her loved ones. CMS is grateful for her service to our country.”
    • FEHBlog note — Dr. Wilensky, who passed away on July 11 at age 81, served as CMS (then HCFA) Administrator for President George H. W. Bush.
  • Per the AHA News,
    • “The AHA July 16 urged the Center for Medicare and Medicaid Innovation not to implement its newly proposed Increasing Organ Transplant Access Model as currently constructed, expressing concerns about many of its design features. The proposed mandatory payment model would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals would increase access to kidney transplants while preserving or enhancing the quality of care and reducing Medicare expenditures. AHA said that IOTA features could exacerbate inequities and negatively impact quality of care. Specifically, AHA said the IOTA model would add unnecessary disruption and uncertainty to the transplant ecosystem, potentially incentivize sub-par matches given the heavy emphasis on volume and would be discordant with other regulatory requirements.” 

From the public health and medical research front,

  • Per a press release, the Institute for Clinical and Economic Review published its Final Evidence Report on Treatment for Chronic Obstructive Pulmonary Disease 
    • “Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ensifentrine added to maintenance therapy compared to maintenance therapy alone; ICER calculated a health-benefit price benchmark (HBPB) for ensifentrine between $7,500 to $12,700 per year, and the therapy is priced at $35,400 per year.
  • The National Institutes of Health announced,
    • “In a new analysis of data, researchers at the National Institutes of Health (NIH) have found that taking a daily supplement containing antioxidant vitamins and minerals slows progression of late-stage dry age-related macular degeneration (AMD), potentially helping people with late-stage disease preserve their central vision. Researchers reviewed the original retinal scans of participants in the Age-Related Eye Diseases Studies (AREDS and AREDS2) and found that, for people with late-stage dry AMD, taking the antioxidant supplement slowed expansion of geographic atrophy regions towards the central foveal region of the retina. The study was published in the journal Ophthalmology.
    • “We’ve known for a long time that AREDS2 supplements help slow the progression from intermediate to late AMD. Our analysis shows that taking AREDS2 supplements can also slow disease progression in people with late dry AMD,” said Tiarnan Keenan, M.D., Ph.D., of NIH’s National Eye Institute (NEI) and lead author of the study. “These findings support the continued use of AREDS2 supplements by people with late dry AMD.”
  • Beckers Hospital Review shares ophthalmologist organization opinions on eye conditions and Ozempic use.
    • A week after a study connected Ozempic and Wegovy to an eye condition that can cause partial blindness, two ophthalmology organizations said they have “been aware of other vision changes for some time.”
    • Changing sugar levels can affect the shape of the eye’s lens, according to the American Academy of Ophthalmology and North American Neuro-Ophthalmology Society. Because of this, semaglutide, the active ingredient of Type 2 diabetes drug Ozempic and weight loss medication Wegovy, might lead to blurry vision. 
    • The ophthalmology groups said previous studies have also found that semaglutide can exacerbate diabetic retinopathy and macular complications. 
    • “The medical community has been aware of other vision changes with semaglutide for some time,” the organizations said in a July 8 joint statement. However, the research associating the drug to non-arteritic anterior ischemic optic neuropathy [NAION] is the first of its kind. 
    • “The condition restricts blood flow to the optic nerve, which causes sudden, painless loss of vision in one eye, the statement said. The research did not confirm a causal relationship between the medications and NAION, but it identified a potential link.: * * *
    • “The subjects in this study were either overweight or obese or had Type 2 diabetes. People who have diabetes are already at risk of NAION,” the organizations said. “Other risk factors for NAION include heart disease, history of heart attack, high blood pressure and sleep apnea” — health risks that also are tied to diabetes and obesity. 
    • “In response to the study, Novo Nordisk, the manufacturer of Ozempic and Wegovy, said it takes adverse event reports seriously. 
    • “The ophthalmology groups said they recommend patients continue taking the medications unless they experience a sudden vision loss.”  
  • The AHA News points out,
    • “Antimicrobial-resistant infections remained above pre-pandemic levels in 2022, the Centers for Disease Control and Prevention reported July 16. CDC data show that infections, which increased 20% during the pandemic compared to the pre-pandemic period — peaked in 2021.
    • “The increases in antimicrobial resistance (AR) burden seen in 2020 and 2021 are likely due in part to the impact of COVID-19, which pushed healthcare facilities, health departments and communities near their breaking points,” the agency notes. “This resulted in longer hospital stays for hospitalized patients (including those diagnosed with COVID-19), challenged the implementation of infection prevention and control practices and increased inappropriate antibiotic use.” 
    • “The AHA provides resources which promote the appropriate use of medical resources.”
  • Medscape summarized the June meeting decisions of the CDC’s Advisory Committee on Immunization Practices and identifies the five immunizations that adults need beyond Covid and the flu vaccines.
  • Medscape also discusses the use of remote trials to accelerate the testing of new long Covid treatments.

From the U.S. healthcare business front,

  • Beckers Payer Issues and Fierce Healthcare report on UnitedHealthcare’s second quarter financial results announced today.
    • BPI – “UnitedHealth Group posted $4.2 billion in net income during the second quarter of 2024, a 23% decline year over year.
    • “The company said it has restored the majority of affected Change Healthcare services and has provided more than $9 billion in advance funding and loans to providers. The total full year impact of the breach is estimated at $1.90 to $2.05 per share, with the company raising the estimated total cost of the attack to around $2.45 billion.”
    • FH – “UnitedHealth saw an elevated medical loss ratio in Q2, and executives pointed to the Change Healthcare cyberattack as a key factor.
    • “UnitedHealthcare had an MLR of 85.1% in the second quarter, compared to 83.2% in the prior year quarter. The insurer called out multiple elements that contributed to the elevated ratio in its earnings call on Tuesday morning. For one, UHC CEO Brian Thompson said there’s a clear difference in coding intensity after the insurer ended care waivers offered following the cyberattack.
    • “Amid the cyberattack, UnitedHealth eased prior authorization and utilization management to support cash flow to providers.”
  • Beckers Hospital Review provides details on U.S. News and World Report’s latest U.S. hospital rankings by State and by specialty.
  • pwc reports,
    • “Commercial health care spending growth is estimated to grow to its highest level in 13 years, according to PwC’s newest research into annual medical cost trend. PwC’s Health Research Institute (HRI) is projecting an 8% year-on-year medical cost trend in 2025 for the Group market and 7.5% for the Individual market. This near-record trend is driven by inflationary pressure, prescription drug spending and behavioral health utilization.
    • “HRI is also restating the 2023 and 2024 medical cost trends as higher than previously reported based on the input of health plans we surveyed and their trend experience. This unfavorable trend reflects higher than expected utilization of glucagon-like peptide-1 (GLP-1) drugs as well as higher acuity (higher levels of care) inpatient and outpatient utilization. Inpatient and outpatient utilization were driven by demand from care deferred since the pandemic, which was met by newly created capacity as sites of care shifted to outpatient, professional and ambulatory care settings.
    • “The same inflationary pressure the healthcare industry has felt since 2022 is expected to persist into 2025, as providers look for margin growth and work to recoup rising operating expenses through health plan contracts. The costs of GLP-1 drugs are on a rising trajectory that impacts overall medical costs. Innovation in prescription drugs for chronic conditions and increasing use of behavioral health services are reaching a tipping point that will likely drive further cost inflation.
    • “Meanwhile, cost deflators are not enough to offset cost inflators. The growing adoption of biosimilar medications may provide some relief, while many health plans are looking inward to find opportunities across business operations to generate additional cost savings. Today’s medical cost trend is an urgent call to action for healthcare organizations to rethink their strategies to manage the total cost of care more effectively – a challenge that is inextricably linked to the broader challenge of affordability, defined by the Affordable Care Act as the percentage of a member’s household income used for healthcare expenses.”
  • FEHBlog note — OUCH!
  • MedCity News discusses the improving state of the digital health fundraising market.

Tuesday Tidbits

David Ermer–AHRQ, Congress, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • This morning, the Federal Trade Commission released an interim staff report on its ongoing investigation of prescription benefit managers. The report was favorably received by Senators Wyden and Grassley. Healthcare Dive summarizes the report here.
  • The FEHBlog recalls when around 2009 the State of New York went after UnitedHealthcare for offering a for profit service that provided usual, reasonable and customary rates for out-of-network providers. In a legal settlement, UnitedHealthcare transferred the service to a new not-for-profit company called Fair Health. Meanwhile most health plans had switched to the Medicare Part RBRVS pricing as base for its UCR reimbursements. Nevertheless, Fair Health is still around.
  • Today, the American Hospital Association News tells us,
    • “An op-ed published July 9 in Modern Healthcare written by AHA President and CEO Rick Pollack and Catholic Health Association President and CEO Sr. Mary Haddad discusses why nonprofit hospitals need positive margins. The commentary piece seeks to add important context and education to the conversation around nonprofit hospitals’ community benefit, tax-exempt status and other issues, arguing that positive margins are necessary to maintain basic services and advance care for all patients and communities 24/7. “Barely making ends meet or operating at a financial loss should never be the goal or an acceptable status quo for any nonprofit healthcare organization,” Pollack and Haddad write. “It’s not just bad economics; it also impedes institutions’ ability to deliver services and improve health outcomes.”
  • If the regulators are considering taking a page out of the Fair Health playbook, consider this finding from a USC-Brookings report issued last September:
    • “Pre-tax operating margins for the three largest PBMs averaged a bit more than 4% of their revenues in 2022. Since PBMs’ revenues encompass both the administrative fees charged to PBMs and payers’ net payments for claims, this implies that even completely eliminating PBMs’ margins [a no-no] would only modestly reduce payers’ drug-related costs. Achieving larger reductions would require reducing the revenue captured by pharmacies or, particularly, manufacturers. Ultimately, the amount of revenue that manufacturers capture depends principally on the extent of intellectual property protections related to drugs and whether and how the prices that drug manufacturers receive are regulated.”
  • The healthcare industry is complex, to say the least, and there are no simple answers.

From the public health and medical research front,

  • “Did you know that the U.S. Preventive Services Task Force (Task Force) has a free app called Prevention TaskForce? This app can help healthcare professionals identify which screenings, counseling interventions, and preventive medications are right for their patients. It includes all current Task Force recommendations and can be searched by specific patient characteristics, such as age, sex/gender, and selected behavioral risk factors. Download the app, on mobile or desktop, to find the preventive services that can help keep your patients healthy.”
    • “For more information and to download the app, click here.”
  • STAT News reports,
    • “In a long-awaited study, patients in Australia will soon receive an IV infusion designed to transform their own immune cells into swarms of cancer-fighting drones.
    • “The trial, announced on Tuesday by Interius Biotherapeutics, will be the first to test what’s known technically as in vivo CAR-T therapy. Researchers have long hoped the approach could provide a potentially cheaper, safer, and more scalable version of the cell therapies that are curative for some blood cancer patients but remain out of reach for many. 
    • “Interius received regulatory clearance on June 28 and will dose up to 30 patients, beginning in the fall. It beat out several competitors, including one with over $1 billion in funding, to the first-in-human trial.  
    • “There are absolutely people alive out there today that would not have been without the CAR technology,” said Dora Mitchell, Interius’ senior vice president for operations. But the therapy is still only delivered in some places in the U.S. and Europe and almost nowhere else. “The vision that catalyzed the formation of Interius was: can we bring this to the masses?”
  • Healio informs us,
    • “There is insignificant evidence to support recommendations that children with autism will benefit from intensive interventions, according to the results of a meta-analysis published in JAMA Pediatrics.
    • “One of the study’s authors told Healio that in reviewing standard intervention recommendations for autism in children, she found that one recommended that children receive at least 20 hours or up to 40 hours of intensive intervention per week.
    • “This recommendation originated initially from a quasi-experimental study conducted in the ’80s that, although remarkable for the time, was flawed,” Micheal P. Sandbank, PhD, director of The Brain and Language Lab at the University of Texas at Austin, told Healio. “There have been additional studies since then, but most were quasi-experimental and compared intensive intervention with different uncontrolled supports, failing to isolate the effect of intensity specifically from the effect of providing a systematic and comprehensive intervention approach.”
  • The Washington Post explains what to know about six popular home tests for urinary tract infections, menopause, allergies, colon cancer, A1c blood sugar and thyroid conditions.

From the U.S. healthcare business front,

  • Beckers Hospital CFO report informs us,
    • “Average hospital margins year to date remained steadfast in May at 3.8%, according to Kaufman Hall’s “National Hospital Flash Report,” released July 9.
    • “Hospital financial performance remained relatively unchanged during the month of May, and the rate of change slowed for margins and other key performance indicators, which reflects stabilization,” wrote Erik Swanson, senior vice president at Kaufman Hall.
    • “The stabilization is a positive sign for hospitals after ending the year with average margins at 1.9%. The average hospital margin shot up in January to 4.6% and then decreased slightly in February and March.
    • “From April to May, the monthly average operating margin index dipped from 4.2% to 3.7%. Operating margins increased 23% year to date over the same period last year.”
  • BioPharma Dive reports,
    • “Pfizer’s top scientist Mikael Dolsten is stepping down after leading the drugmaker’s research and development for the past 15 years, a period that includes Pfizer’s remarkable success developing a COVID-19 vaccine but ends with the company at a crossroads.
    • “On Tuesday, Pfizer said it has begun searching for a successor to Dolsten, who in 2010 became chief scientific officer as well as R&D head. The process is expected to last “probably through early next year,” Pfizer said.
    • “Dolsten will help with the search and continue to serve in his current position until a successor is in place and “any necessary transition is complete,” according to Pfizer.”

Weekend Update

David Ermer–CDC, CMS, Congress, Medical / Rx research, Mental health care, U.S. Healthcare–

From Washington, DC,

  • The Supreme Court will end its October 2023 term tomorrow by releasing a final batch of three opinions.
  • The New York Times reports,
    • “The Biden administration said this week that it opposed gender-affirming surgery for minors, the most explicit statement to date on the subject from a president who has been a staunch supporter of transgender rights.
    • “The White House announcement was sent to The New York Times on Wednesday in response to an article reporting that staff in the office of Adm. Rachel Levine, an assistant secretary at the Department of Health and Human Services, had urged an influential international transgender health organization to remove age minimums for surgery from its treatment guidelines for minors.” * * *
    • “The Supreme Court agreed on Monday to hear a challenge — brought in part by the Biden administration — to a Tennessee law that bans treatments including puberty blockers, hormone therapy and surgery for transgender minors. This will be first time the justices will decide on the constitutionality of such statewide bans.”
  • The Washington Post lets us know,
    • House Republican leaders are asking government watchdogs to investigate health insurance sign-ups through the Affordable Care Act, citing reports that allege insurance brokers are fraudulently enrolling customers into some ACA health plans and that millions of Americans may be wrongly benefiting from federal insurance subsidies.
    • The House Energy and Commerce, Ways and Means, and Judiciary Committees requested Friday that the Government Accountability Office and the inspector general at the Department of Health and Human Services open investigations into the “astonishing level” of potential enrollment fraud, according to letters shared with The Washington Post.

From the public health and medical research front,

  • Reuters tells us,
    • “The U.S. Food and Drug Administration has begun testing more dairy products for evidence of the bird flu virus as outbreaks spread among dairy herds across the country.
    • “More than 120 dairy herds in 12 states have tested positive for bird flu since March, according to the U.S. Department of Agriculture. Federal officials have warned that further spread among dairy cows could heighten the risk of human infections.
    • “The focus of additional testing is to ensure that pasteurization inactivates the virus, said Don Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, on a call with reporters.
    • “Prior FDA testing of 297 retail dairy samples came back negative for evidence of the virus.
    • “The agency continues to strongly advise against consumption of raw milk products, Prater said.”
  • The Washington Post informs us,
    • “People over 50 with anxiety may be up to twice as likely to develop Parkinson’s disease as their peers without anxiety, a new analysis suggests.
    • “The study, published in the British Journal of General Practice, looked at primary care data from the United Kingdom. Researchers compared a group of 109,435 people 50 and older who were diagnosed with a first episode of anxiety between 2008 and 2018 with a control group of 987,691 people without anxiety.
    • “Researchers said, of those in the study, 331 patients with an anxiety diagnosis developed Parkinson’s disease over the decade, and the average patient who developed the disease did so 4.9 years after their first anxiety diagnosis.
    • “After adjusting for age, lifestyle factors, mental illness and other factors, people with anxiety were still twice as likely to develop Parkinson’s disease than those without an anxiety diagnosis. Those who developed the disease were also likelier to be male and in higher socioeconomic groups.”
  • STAT News adds,
    • “Fighting Alzheimer’s disease is a race against time. By the time most patients are diagnosed and treated, their cognitive symptoms have already advanced significantly.
    • “New research, though, pinpoints protein changes in cerebrospinal fluid highly associated with the development of Alzheimer’s disease. A better biological understanding of the brain disorder could foster new treatments and earlier intervention — as early as 20 years before onset of symptoms according to models from the study.
    • “The findings, published Wednesday in Science Translational Medicine, coincide with revised criteria from the Alzheimer’s Association that lean into the need for biology-based diagnosis and staging of the disease. The underlying biology of Alzheimer’s is still a scientific conundrum, but the approval of a drug targeting the disease’s amyloid pathology has sparked a push for blood and other tests to detect proteins associated with disease progression earlier, when treatment can be more successful.
    • “The study tracked upwards of 5,000 proteins to capture a dynamic picture of protein activity in patients with Alzheimer’s. “We take all these different proteins that we measure and we cluster them into these things called modules, that reflect different biological pathways, or processes, or cell types,” said study author Erik Johnson, assistant professor of neurology at Emory University. Those clusters of protein activity can serve as a springboard for both disease prediction and drug treatment experiments, he said.
  • Per NPR Shots,
    • “About 170 billion cells are in the brain, and as they go about their regular tasks, they produce waste — a lot of it. To stay healthy, the brain needs to wash away all that debris. But how exactly it does this has remained a mystery.
    • “Now, two teams of scientists have published three papers that offer a detailed description of the brain’s waste-removal system. Their insights could help researchers better understand, treat and perhaps prevent a broad range of brain disorders.
    • “The papers, all published in the journal Nature, suggest that during sleep, slow electrical waves push the fluid around cells from deep in the brain to its surface. There, a sophisticated interface allows the waste products in that fluid to be absorbed into the bloodstream, which takes them to the liver and kidneys to be removed from the body.
    • “One of the waste products carried away is amyloid, the substance that forms sticky plaques in the brains of patients with Alzheimer’s disease.
  • Medscape notes,
    • “Certain medications that are used to treat benign prostatic hyperplasia (BPH) are associated with a reduced risk for dementia with Lewy bodies (DLB), the second most common neurodegenerative type of dementia after Alzheimer’s disease. 
    • “Investigators found older men taking alpha-1 blockers terazosin, doxazosin, or alfuzosin (Tz/Dz/Az) were 40% less likely to develop DLB than those taking tamsulosin and 37% less likely than men taking the 5-alpha reductase inhibitors (5ARI) finasteride and dutasteride.
    • “These results are exciting because right now there are no drugs to prevent or treat dementia with Lewy bodies,” study investigator Jacob E. Simmering, PhD, of the University of Iowa in Iowa City, said in a press release. “If we can determine that an existing drug can offer protection against this debilitating disease, that has the potential to greatly reduce its effects.”
    • “The findings were published online on June 19, 2024, in Neurology.”
  • BioPharma Dive discusses “microscopic tunnels [which] are a goldmine for new medicines. Ion channel research made Vertex Pharmaceuticals one of the world’s most valuable biotechs. Now, other drug hunters have joined in, betting the field is ready to treat an array of illnesses.”
    • “It can be difficult to picture just how small a human cell is. On average, it’s one-tenth as wide as a strand of hair and 25 times smaller than a grain of salt. Tinier still are the thousands of ion channels anchored into the fluid, oily shell that encases these microscopic worlds.
    • “The channels act as canals; though, instead of water, they control the movement of electrically charged particles like sodium, potassium, calcium and chloride. When cells are stimulated in certain ways, the canals open, permitting ions to flood in or out. They then shut and return to a “resting” state. The opening and closing happens hundreds of times a second and actually jolts the cell, in essence telling it, “Something is happening, react!”
  • STAT News points out,
    • “A few years ago, the Centers for Medicare and Medicaid Services launched a big experiment. The agency wanted to see if financial incentives and penalties would improve care for people with end-stage kidney disease. So far, it hasn’t worked, a new study finds.
    • “The End-Stage Renal Disease Treatment Choices (ETC) model is a historic effort, both because it’s the largest such experiment in the history of American health care and because, unlike previous CMS Innovation Center pilot programs, it’s mandatory. About 30% of dialysis providers in the country participate, while the other 70% are used as a control group. It’s shaped like a gold-standard, randomized control trial, and run by the entity that covers the majority of health care related to end-stage renal disease, including dialysis. 
    • “Each year, providers are graded on how many patients they can move to home dialysis, which is more affordable for the health care system, and how many people go on to receive kidney transplants, among other metrics. If they do well, they receive some extra money. Those who don’t do well face financial penalties. Both amounts increase with each year of the experiment, up to an 8% bonus or 10% penalty by the end of the program.
    • “Those sticks and carrots don’t seem to be doing much. In a paper published in JAMA Health Forum on Sunday, researchers report a null effect: Providers enrolled in the experiment aren’t moving more patients to home dialysis or transplant than those in the control group.” 

Friday Factoids

David Ermer–CDC, FDA, HSA, Medical / Rx research, Mental health care, NIH, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News reports,
    • “The U.S. Supreme Court June 28 overturned a 1984 ruling in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which required courts to defer to federal agencies to interpret ambiguous laws. Decided by a 6-3 vote [written by Chief Justice Roberts], the Court held:
    • “Chevron is overruled. Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the Administrative Procedure Act requires. Careful attention to the judgment of the Executive Branch may help inform that inquiry. And when a particular statute delegates authority to an agency consistent with constitutional limits, courts must respect the delegation, while ensuring that the agency acts within it. But courts need not and under the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
  • FEHBlog observation: In short, the Supreme Court’s sensible, prospective decision creates a level playing field for American businesses and other citizens challenging administrative actions.
  • Fierce Healthcare tells us,
    • “Attorney General Merrick Garland announced Thursday [June 27, 2024,] a two-week operation in which 193 people across the country, including 76 licensed healthcare providers, were charged for their alleged participation in healthcare fraud schemes.
    • “The 145 cases highlighted by the Department of Justice (DOJ) involved over $2.75 billion of intended losses and $1.6 billion in actual losses, Garland said. Among allegations highlighted by the DOJ were medically unnecessary amniotic wound grafts, diverted HIV medications, online distribution of Adderall and other telemedicine schemes.
    • “As healthcare fraud schemes continue to evolve, so will the Justice Department’s investigative and prosecutorial strategies,” Garland said during a Thursday press conference. “Our messages to those seeking to exploit patients and defraud government programs is clear: You cannot hide your crimes. We will find you, and we will hold you accountable.”
  • Kauffman Hall reports,
    • “In late April, the Centers for Medicare & Medicaid Services (CMS) established new staffing standards for long-term care (LTC) facilities, mandating a minimum of 3.48 hours of nursing care per patient per day, with 33 minutes of that care from a registered nurse, at least one of whom must be always on site. The rule is slated to go into effect in two years for urban nursing homes and three years for rural nursing homes, with some facilities able to apply for hardship exemptions. 
    • “Although about one in five LTC facilities nationwide currently meet these staffing standards, staffing levels vary greatly by both state and facility ownership profile. In 28 states, fewer than a quarter of LTC facilities meet the new standards, and in eight states fewer than 10% of facilities are already in compliance. 
    • “Facilities in Texas are the least ready, with only 4% meeting the new staffing minimums. In terms of ownership structure, only 11% of for-profit facilities—which constitute nearly three quarters of all LTC facilities nationwide—have staffing levels that meet the new staffing minimums. 
    • “The Government Accountability Office projects this new rule will cost LTC facilities $43B over the first ten years, a significant expense at a time when recruiting and retaining nursing talent is already challenging. 
    • “Citing the risk of mass closures from facilities unable to comply, nursing home trade groups are suing to stop the mandate from going into effect, and there is also a bill advancing in the House that would repeal the staffing ratios. That bill is backed by the American Hospital Association, which fears the mandate “would have serious negative, unintended consequences, not only for nursing home patients and facilities, but the entire health continuum.”
  • HR Dive reminds us,
    • “While there’s still a small chance it could be blocked, the first step of the U.S. Department of Labor’s overtime final rule is set to go into effect Monday — raising the minimum salary threshold for overtime from $35,568 to $43,888.
    • “Almost every workplace should be prepared with needed adjustments, but there are still a few last-minute actions HR should undertake if they haven’t to protect their organizations, Victoria Lipnic, partner at Resolution Economics and former EEOC commissioner, and Jonathan Segal, partner at Duane Morris LLP, said at a Monday panel at the Society for Human Resource Management’s annual conference.”
    • The three items are explained in the article. 

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • COVID-19
      • During April and May 2024, COVID-19 activity was lower than at any time since the start of the pandemic. Recent increases need to be considered from that baseline. This includes increases in COVID-19 test positivity and emergency department visits, suggesting growth in COVID-19 activity across several states, and increases in rates of COVID-19–associated hospitalizations among adults 65+ at some Western sites. While there are indications for the potential start of a summer surge, nationally COVID-19 activity remains low. CDC will continue to monitor to see if these recent increases persist.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
    • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remained low for children and adults for the 2023-24 respiratory illness season. COVID-19 vaccines continue to be recommended and can provide a layer of protection.”
  • The Hill lets us know,
    • “The CDC recommended [on June 27, 2024] that all Americans 6 months and older receive the flu vaccine, noting that it will offer protection against the against H1N1, H3N2, and a B/Victoria lineage virus.
    • “And during the 2023-24 flu season, more than 44,900 people are estimated to have died from flu complications.
    • “The CDC emphasized that it was safe to receive the flu and COVID shots at the same time.”
  • Per MedTech Dive,
    • “Cepheid said Thursday it received de novo authorization for the only molecular test in the U.S. to detect hepatitis C virus RNA directly from fingerstick blood samples. 
    • “The Food and Drug Administration authorization positions healthcare professionals to diagnose hepatitis C at the point of care. The agency said that patients could be diagnosed and treated at the same healthcare visit.
    • “Cepheid’s authorization establishes special controls, clearing other companies to bring similar tests to market in the U.S. via the 510(k) pathway.” 
  • Fierce Pharma points out,
    • “After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer and its dominant Prevnar franchise.
    • “At a meeting this week, the CDC’s Advisory Committee on Immunization Practices (ACIP) gave a unanimous vote, with one abstention, in favor of the vaccine in millions of adults. Specifically, the vaccine experts recommended the shot for adults 65 and older who have not yet received a pneumococcal conjugate vaccine, plus for those 19 to 64 with certain underlying medical conditions or other risk factors.
    • “Adults 19 years old and up who have started their pneumococcal vaccine series with Pfizer’s Prevnar 13 but have not received all of the recommended Merck’s Pneumovax 23 doses are also included in ACIP’s endorsement.
    • “The ACIP vote recognizes the clinical profile of Capvaxive for adults in the U.S., and we look forward to the CDC’s final, published recommendations,” Merck’s chief medical officer Eliav Barr, M.D., said in a press release.
    • “Capvaxive protects against 21 serotypes of the bacterial infection that comprise 84% of the pneumococcal disease contracted by adults 50 and older, according to epidemiologic data from the CDC. Pfizer’s leading pneumococcal disease vaccine, Prevnar 20, protects against 20 serotypes that comprise 52% of the disease in that population.
  • The Institute for Clinical and Economic Review announced yesterday,
    • “ICER released a Final Evidence Report assessing the comparative clinical effectiveness and value of MDMA-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD).
    • “ICER’s Chief Medical Officer David Rind, MD stated:
      • “PTSD can be a severe condition affecting nearly all aspects of an individual’s life, and many current therapeutic options are insufficient for many people with PTSD. Despite two randomized trials of MDMA-AP, functional unblinding in the trials and additional concerns around trial design and conduct led to ICER concluding that the publicly available evidence is insufficient to assess the balance of benefits and harms. It was encouraging to learn that FDA is investigating such issues, including those brought to light at our Public Meeting.”
    • “For every report, ICER follows a process that includes numerous opportunities for stakeholders to engage and be involved throughout its development. Our reports always begin with an initial scoping phase, followed by development of a Draft Evidence Report. We consider all of the public comments on the Draft Evidence Report as we put together the revised Evidence Report, which is discussed at a public meeting with patients, clinical experts, manufacturers, payers, and policy experts. After that public discussion, we release the Final Evidence Report.”
  • Per Health Day,
    • “An immunotherapy/chemotherapy combo drug can help early-stage breast cancer patients remain cancer-free following treatment, a new trial shows.
    • “The combo drug, Kadcyla, is already approved to treat patients with advanced HER2-positive breast cancer, researchers said.
    • “The new results show that stage 1 breast cancer patients who received Kadcyla stayed free of invasive cancer five years after treatment.
    • “One year of [Kadcyla] after surgery for patients with a stage 1 HER2-positive cancer leads to outstanding long-term outcomes, making it a reasonable treatment approach for select patients,” said senior study author Dr. Sara Tolaney, chief of breast oncology at Dana-Farber Cancer Institute in Boston.”
  • and
    • “Just 25% of people battling opioid use disorder are getting medications aimed at helping them quit and potentially avoid an overdose, new data shows.
    • “Boosting access to proper treatment might save countless lives.
    • “In 2022, 81,806 opioid-involved overdose deaths were reported in the United States, more than in any previous year,” noted a team led by Deborah Dowell, chief medical officer at the U.S. Centers for Disease Control and Prevention’s Division of Overdose Prevention.
    • “Dowell and her colleagues looked at data collected for 2022 as part of the National Survey on Drug Use and Health. The survey involved almost 57,000 adults.”
  • The National Institutes of Health adds,
    • “Results from a national survey indicate that many Americans, 61%, are unaware that primary care physicians can prescribe medications for opioid use disorder, and 13% incorrectly believed that they could not. The survey, funded by the National Institutes of Health (NIH), also found that 82% of the people who reported ever misusing prescription or illicit opioids expressed comfort in going to their primary care physicians for medications for opioid use disorder. Among those who had not misused opioids, a majority, 74%, reported they would be comfortable referring their loved ones to primary care for these medications.
    • “Notably, Black American respondents were most likely to incorrectly believe they could not receive medications for opioid use disorder via primary care, pointing to an important disparity in information that may further impede access to treatment. The findings suggest there is an important opportunity to increase awareness of these treatments and how to access them – using efforts that employ culturally specific strategies to reach different groups. Decades of research have shown the overwhelming benefit of existing medications for opioid use disorder, such as buprenorphine and methadone.
    • “Primary care is often people’s first point of contact in the health care system and can serve as a crucial setting to talk about addiction and receive lifesaving medications,” said Nora D. Volkow, M.D., Director of NIH’s National Institute on Drug Abuse (NIDA). “We need to provide education and support so that patients feel empowered to seek help from their primary care physician, and their doctors feel prepared to help them.”
  • Behavioral Health Business explains why “Feeding Disorder Treatment Programs Are Urgently Needed for Children with Autism.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Optum will not bid on Steward Health Care’s physician group, Stewardship Health, during the bankrupt health system’s upcoming auction, a Massachusetts state official has confirmed.
    • “The news is a major setback for Steward, which has repeatedly identified selling Stewardship as critical for its financial stabilization. 
    • “Steward took out $150 million in loans to fund the transaction in February. Its attorneys have claimed during federal bankruptcy proceedings that the sale proceeds would be enough to cover debts to certain lenders and, as recently as June 13, the Dallas-based system tied $75 million of new debtor-in-possession financing — which funds operations during restructuring — to the successful completion of a Stewardship sale.
    • “While Steward hammered the importance of selling Stewardship, it only had one public buyer at the table: UnitedHealth-owned Optum. 
  • and
    • “Amwell is implementing a reverse stock split to avoid being kicked off the New York Stock Exchange, the telehealth vendor said Friday. 
    • “The company has struggled to reach profitability, and its stock price has declined precipitously since entering the public markets in 2020. In April, the telehealth company received a warning notice from the NYSE that its stock was trading below minimum standards, closing at less than $1 per share for 30 consecutive days. 
    • “The company’s board of directors approved a 1-for-20 reverse stock split, a maneuver that consolidates the number of existing shares of stock to boost its share price. The split will be effective at market close on July 10.”
  • MedCity News shares expert observations on recent acquisitions by Kaiser Permanente’s Risant Health subsidiary.
    • “Is Risant Health the rising star of scalable, profitable value-based care models for health systems?
    • “It’s a little early to break out the champagne and toast to the company’s success, but it might soon be time to start thinking about ordering some flute glasses should a celebration be in order.”
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Rhode Island is eliminating nearly 65% of prior authorization requirements for primary care providers by early 2025. 
    • “BCBSRI reviewed data to identify some of the most common orders that create additional work for PCPs. Radiology and cardiology services lead the list of requirements being cut, and the changes will apply across commercial and Medicare plans, according to a June 27 news release. * * *
    • “BCBSRI removed all prior authorization for outpatient behavioral services in 2018. Other payers such as UnitedHealthcare, Cigna, BCBS Michigan, Point32Health and Aetna have all reduced prior authorization requirements recently.”
  • The Employee Benefits Research Institute presents an EBRI Issue Brief titled “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Medication Adherence.”
    • “IRS Notice 2019-45 allows health savings account (HSA)-eligible health plans the flexibility to cover 14 drug classes and other health services used to prevent the exacerbation of chronic conditions prior to meeting the plan deductible. In this Issue Brief, we used claims data to quantify the effect of expanding pre-deductible coverage on medication adherence among enrollees with certain chronic conditions. We found some evidence that expanding pre-deductible coverage in HSA-eligible health plans increased medication adherence in 2022, but not earlier.”

Monday Roundup

David Ermer–CDC, FDA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • MedPage Today reports about FDA Commissioner Robert Califf’s speech given this past weekend.
    • “We are wowing the world in technology — much of it related to the field that you’re interested in [diabetes],” he told attendees at the keynote opening session of the American Diabetes Association Scientific Sessions. “We are not succeeding in implementation of the things that we know. We need to bring these things together so that we harness technology, particularly digital technology and AI [artificial intelligence], to the benefit of the people that we care about.” * * *
    • “High fasting glucose, poor diet, and high BMI are all in the top five factors behind death and loss of disability-adjusted life years in the U.S. And according to some sources, diabetes has now surpassed cancer as the leader in the economic cost of healthcare in the U.S., with some 34 million adults having some form of diabetes in 2020, he said. “This is an honor I’m not sure I’d want to have, but it does give you a lot of power to do things to make this better.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services June 24 released a final rule that would disincentivize health care providers for interfering with the access, exchange or use of electronic health information. AHA previously expressed concern when the rule was proposed, saying it could threaten the financial viability of economically fragile hospitals.”
    • “In the final rule, hospitals under the Medicare Promoting Interoperability Program found to have committed information blocking would experience a reduction of the market basket update by 75%. Critical access hospitals would see a reduction from 101% to 100% of reasonable costs, while clinicians in Medicare’s Merit-based Incentive Payment System would receive a score of zero in the MIPS Promoting Interoperability performance category. Providers in accountable care organizations that commit information blocking would be ineligible to participate in the Medicare Shared Savings program for at least one year and may not receive revenue they may have earned through the program.” 
  • HHS adds,
    • “This HHS final rule complements OIG’s final rule from June 2023 that established penalties for information blocking actors other than health care providers, as identified in the Cures Act (health information technology (IT) developers of certified health IT or other entities offering certified health IT, health information exchanges, and health information networks). If OIG determines that any of these individuals or entities committed information blocking, they may be subject to a civil monetary penalty of up to $1 million per violation.
    • “The Office of the National Coordinator for Health Information Technology (ONC) and CMS will host a joint information session about the final rule on June 26, 2024, at 2 pm ET. More information can be found at healthit.gov/informationblocking and via ONC’s X account, @ONC_HealthIT 
  • Per Govexec,
    • “The U.S. Postal Service is not living up to its projected cost savings from its plan to overhaul the agency, according to a new [USPS Inspector General] audit, which found the 10-year initiative is no longer offering insight for measuring the success of the reforms. 
    • “USPS is bringing in more revenue than it anticipated when it first laid out its Delivering for America plan in 2021, though its costs have also accelerated in a way it did not project. That has led to overall losses of $950 million in fiscal 2022 and $6.5 billion in fiscal 2023, despite postal management predicting it would have broken even by now.” 
  • Fierce Healthcare lets us know,
    • “The [U.S.] Supreme Court will not hear a legal challenge to the nearly $2.7 billion Blue Cross Blue Shield [antitrust] settlement. * * *
    • In a statement to Reuters, BCBSA said it welcomes the decision as well as “the opportunity to begin to implement this settlement.”

From the public health and medical research front,

  • BioPharma Dive points out
    • “An experimental medicine helped people with a deadly heart disease stay out of the hospital and live longer in a closely watched clinical trial, a finding that could pave the way for a regulatory approval and help its developer, Alnylam Pharmaceuticals, rebound from a significant setback.
    • “Trial data released Monday showed trial participants with the disease, transthyretin amyloidosis cardiomyopathy, and treated with Alnylam’s drug had a 28% lower risk of death from any cause or recurrent cardiovascular event, compared to those given a placebo. Alnylam said its drug was associated with a 33% risk reduction versus placebo among people who weren’t on another drug for the condition, Pfizer’s tafamidis, at the study’s start.”
  • and
    • “Novo Nordisk on Sunday disclosed detailed clinical trial results for an experimental hemophilia treatment dubbed Mim8, showing once-weekly and once-monthly doses of the antibody drug controlled bleeding in people with the more common “A” form of the disorder.
    • “The data, which were presented at the International Society on Thrombosis and Haemostasis Annual Congress in Thailand, fill in a positive picture for Mim8’s effectiveness and safety. Novo had said in May that the Phase 3 trial, called Frontier-2, succeeded and shared topline findings.
    • “Among people who had not previously been on preventive treatment, researchers reported zero bleeds in 86% of study participants who received once-weekly Mim8, and 95% of those given the once-monthly dose. Those figures were 66% and 65%, respectively, among people in the trial who had prior preventive treatment.”
  • Per MedTechDive,
    • “Insulet is looking to expand the label for its Omnipod 5 insulin pump for people with Type 2 diabetes. The company said Friday it recently filed with the Food and Drug Administration. 
    • “Insulet presented study results at the American Diabetes Association’s 84th Scientific Sessions that evaluated Omnipod 5 in people with Type 2 diabetes who were taking basal insulin or multiple daily injections. The results showed “substantial improvements in blood glucose outcomes and overall quality of life,” said study chair Francisco Pasquel, an associate professor of endocrinology at Emory School of Medicine.
    • “Insulet’s filing comes as other diabetes technology companies look to expand their offerings for people with Type 2 diabetes. Tandem Diabetes Care has published results showing how its T:slim x2 pump with Control IQ improved time in range for people with Type 2 diabetes, and Dexcom and Abbott recently gained FDA clearance for continuous glucose monitors tailored for people with Type 2 who don’t take insulin.”
  • Per Beckers Hospital Review,
    • “Orlando, Fla.-based AdventHealth Cancer Institute launched a first-of-its-kind bladder cancer vaccine trial that will use patient-customized mRNA vaccines.
    • “The Phase II trial participants will receive pembrolizumab combined with a customized immunotherapy injection designed using the unique proteins present in each patient’s tumors, according to a May 23 system news release. Participants will receive infusions every six weeks for one year and then receive one vaccine injection every three weeks for nine doses.
    • “This vaccine is precision medicine at its best,” Guru Sonpavde, MD, medical director of genitourinary oncology at the AdventHealth Cancer Institute, as well as a member of the trial’s global steering committee, said in the release.”
  • The Centers for Disease Control last week released a report on loneliness in the U.S. 2022. The study found that loneliness was most prevalent among sexual and gender minorities.
  • STAT News notes,
    • “New research shows that, in spite of recommendations discouraging use of aspirin in primary prevention of cardiovascular disease among older adults, nearly a third of adults 60 years and older are still using it for this very purpose.
    • “The study, published on Monday in Annals of Internal Medicine, found that 18.5 million adults 60 and older without cardiovascular disease reported using preventative aspirin in 2021. Of those, 3.3 million were using the pills without medical advice. * * *
    • “John Wong, vice chair of the USPSTF, emphasized increased physician-patient conversations in deciding how to best prevent cardiovascular disease. “There are things at the individual level our population evidence-based recommendations don’t take into account,” Wong said.
    • “If a patient and their physician decide that daily aspirin is too risky, they can still plan to manage obesity, stop smoking, and regularly screen for high blood pressure and metabolic disease, said Wong. “Those are all evidence-based, proven methods to prevent that first heart attack or first stroke.”
  • Scientific American discusses exercises that can help older Americans reduce the risk of dangerous falls.
  • The Washington Post and Consumer Reports offer “tips can help you move [heavy] objects safely — and with less effort — even as you get older.

From the U.S. healthcare business front,

  • Fierce Healthcare explores UnitedHealthcare’s top selling health insurance product Surest.
  • Beckers Hospital Review explains why “Walgreens is on a mission to attain provider status for its pharmacists.” 
  • FiercePharma reports,
    • “GLP-1 heavyweights Eli Lilly and Novo Nordisk are trading haymakers as they scale up production to meet the overwhelming demand for their revolutionary obesity drugs.
    • “A month after Lilly revealed a $5.3 billion investment to increase its manufacturing capacity, Novo has answered.
    • “On Monday, the Danish drugmaker said it will spend $4.1 billion to construct a second fill-finish plant at its sprawling campus in Clayton, North Carolina. At 1.4 million square feet, the site will match the combined floor space of Novo’s three current manufacturing sites in the state, the company said.
    • “At the new plant, Novo will produce blood sugar modulating treatments Ozempic, for diabetes, and Wegovy, for obesity. The outlay is part of Novo’s planned $6.8 billion investment in manufacturing this year, up from $3.9 billion in 2023.”     

Weekend Update

David Ermer–Congress, Mental health care, SCOTUS, U.S. Healthcare–

From Washington, DC,

From the public health and medical research front,

  • CNN reports
    • “For some people with depression, finding the right medication can be a process of trial-and-error lasting for months or even years, which can worsen symptoms.
    • “But what if doctors, when diagnosing someone with depression, could assess exactly how depression is affecting a patient’s brain and prescribe a treatment that gets it right the first time?
    • “Scientists may be a step closer to that reality, thanks to new research that has identified six subtypes — or “biotypes” — of major depression via brain imaging combined with machine learning. The study, published Monday in the journal Nature Medicine, also tested how three of those biotypes responded to different antidepressants and therapies.”
  • The Washington Post published one of its occasional Medical Mysteries articles. In this case, the Post explains why a breastfeeding mother experience crippling back pain.

From the U.S. health business front,

  • NPR Shots’ “bill of the month” features a Texas urgent care center bill.
    • “One evening last December, Tieqiao Zhang felt severe stomach pain.
    • “After it subsided later that night, he thought it might be food poisoning. When the pain returned the next morning, Zhang realized the source of his pain might not be as “simple as bad food.”
    • “He didn’t want to wait for an appointment with his regular doctor, but he also wasn’t sure if the pain warranted emergency care, he said.
    • “Zhang, 50, opted to visit Parkland Health’s Urgent Care Emergency Center, a clinic near his home in Dallas where he’d been treated in the past. It’s on the campus of Parkland, the city’s largest public hospital, which has a separate emergency room.
    • “He believed the clinic was an urgent care center, he said.”
  • In short, this in-network facility, which Mr. Zhang visited. twice, turned out to be an extension of Parkland’s emergency room, and he was hit with a $19,543 bill on which he owed $1,000 in copayments. People should be placed on notice when they will be billed at hospital rates.
  • The Wall Street Journal adds,
    • “Rising healthcare prices have long eroded American wages. They are doing that by eating into jobs. 
    • “Companies shed workers in the year after local hospitals raise their prices, new research found. Higher hospital prices pushed up premiums for employees’ health insurance, which businesses help pay for. 
    • “The new study, scheduled to be published Monday as a National Bureau of Economic Research working paper, is a comprehensive look at one-way companies manage those higher premiums: cutting payrolls. 
    • “Employers that face increases in healthcare spending respond by laying off workers who they can no longer afford to retain,” said Zarek Brot-Goldberg, an economist at the University of Chicago and one of the researchers involved in the study. 
  • Fortune Well points out,
    • “Just what is the wellness level of today’s corporate workforce? That all depends on who you ask.
    • “Because while C-suite executives overwhelmingly believe their employees are feeling mentally healthy, professionally fostered, and personally satisfied and included, many workers themselves would beg to differ.
    • “That’s according to the findings of the third annual Workplace Well-being report from Deloitte. The audit and tax consultancy firm collaborated with independent researchers Workplace Intelligence to survey 3,150 executives, managers and workers across four countries (with 57% of respondents from the U.S., and others from the U.K., Canada, and Australia) to check in on the state of human sustainability—which is the degree to which an organization values people and leaves them with greater health and well-being, stronger skills for employability, opportunities for advancement, and a heightened connection to purpose. 
    • “A whopping 82% of executives believe their company is advancing human sustainability in general—but only 56% of workers agree.
    • “Other gulfs in understanding, according to the findings: Around 90% of executives believe working for their company has a positive effect on worker well-being, skills development, career advancement, inclusion and belonging, and their sense of purpose and meaning; only 60% of workers agree.
  • On the bright side, a majority of the workers are in the agreement with the C-suite execs. It could be worse.