Thursday Miscellany

NIH

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Obesity, SDOH, Telehealth–

From Washington, DC,

  • Govexec informs us,
    • “The Senate on Thursday made progress on advancing bipartisan spending bills for fiscal 2025, though members of both parties acknowledged significant divisions remain between the two sides. 
    • “The chamber’s Appropriations Committee approved three of the 12 annual funding measures Congress must pass each year—those funding the departments of Agriculture and Veterans Affairs, as well as the legislative branch—in unanimous, 27-0 votes. While that marked a significant step forward in the fiscal 2025 process and an accomplishment that has eluded the panel’s House counterpart—which has advanced its bills to date only along partisan lines—the Senate could not come to a bipartisan agreement on how much money to allocate for the remaining nine funding measures.”
  • and
    • “The Senate on Wednesday voted 55-37 to confirm Anne Wagner as the third member of the Federal Labor Relations Authority, finally bringing the agency’s political leadership to nearly full strength.
    • “Similar to the National Labor Relations Board’s role overseeing collective bargaining in the private sector, the FLRA governs labor-management relations at federal agencies, with a three-member board that settles unfair labor practice complaints and other disputes between unions and management.” * * *
    • “Federal employee unions rejoiced at the news that the FLRA’s board was now fully staffed. The last 18 months of deadlock between [Colleen Duffy] Kiko and FLRA Chairwoman Susan Tsui Grundmann has meant the board could only rule in noncontroversial cases.”
  • The American Hospital Association News lets us know,
    • “The Senate Committee on Health, Education, Labor and Pensions held a hearing July 11 on medical debt. The AHA submitted a statement for the hearing that highlighted how the quality of insurance coverage is a driver of medical debt, saying that coverage for many patients is either insufficient or unavailable. The AHA discussed hospital and health system efforts offering financial and other assistance, and that hospitals absorb billions of dollars in losses for patients who cannot pay their bills, mainly due to inadequate commercial insurance coverage. To address the issue, the AHA urged Congress to restrict the sale of high-deductible health plans to individuals with the ability to afford the associated cost-sharing; prohibit the sale of health-sharing ministry products and short-term limited-duration plans that go longer than 90 days; and lower the maximum out-of-pocket cost-sharing limits, among other changes.”
    • That’s nuts, and it’s worth adding that all of the witnesses, except for one, were from the creditor side. Here’s a link to the American Enterprise Institute testimony.
  • The AHA News adds,
    • “The Centers for Medicare & Medicaid Services July 10 announced there will be 133 participants representing 772 practices for its new Making Care Primary Model. Participants in this voluntary model are from Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. The model, which began July 1 and will run through 2034, seeks to improve care management and care coordination, enable primary care clinicians to partner with health care specialists, and use community-based connections to address patients’ health needs as well as their health-related social needs such as housing and nutrition.”
  • and
    • “The Centers for Medicare & Medicaid Services recently released results of an air ambulance qualifying payment amount calculations audit on Aetna Health in Texas. The report found that Aetna used practices that did not comply with federal requirements, and strongly recommended corrective actions. Specifically, the report found that Aetna failed to “properly calculate the QPA by using claim paid amounts instead of contracted rates, and counting each claim as its own contracted rate, even when the claims were for the same amounts for the same item or service and to the same provider of air ambulance services.” Aetna may also be subjected to future audits.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Research into chronic conditions affecting women is significantly lacking, and the National Institutes of Health and other agencies should do more to investigate issues that lead to worse medical treatment for women, a new report from the National Academies of Sciences, Engineering and Medicine says.
    • “Women are disproportionately affected by chronic illnesses, including Alzheimer’s disease and depression, according to the study requested by NIH’s Office of Research on Women’s Health and published Wednesday.
    • “But inadequate research in women’s health “hinders a comprehensive understanding of the impact on women” of these and other chronic illnesses, the report’s authors write. Further research is needed, particularly for Black women, who are more likely to die of a chronic illness than White women, the study says.”
  • and
    • “Nearly 1 in 10 people infected with the coronavirus during pregnancy developed long covid, according to a study published Thursday in the journal Obstetrics and Gynecology.
    • “Thursday’s study, which highlights the consequences of the virus during pregnancy, suggests long covid is more prevalent among people infected while pregnant than in the population overall. As many as 7 percent of Americans report having symptoms associated with long covid, according to a 2022 report from the Centers for Disease Control and Prevention. Some surveys suggest a far higher incidence of long covid in the general population.” * * *
    • “I was initially surprised at the prevalence of long covid in this population,” said Torri Metz, one of the study’s lead authors and a maternal-fetal medicine specialist at University of Utah Health. “It really drew my attention to the fact I need to have this on my radar when I am seeing patients.”
  • NBC News informs us,
    • “A key mystery behind one of the most common autoimmune diseases may finally have an answer.
    • “Researchers at Northwestern Medicine and Brigham and Women’s Hospital say they’ve discovered a root cause of lupus, a disease that affects hundreds of thousands of people in the U.S. 
    • “Scientists have long suspected that a person’s genetics or hormones may predispose them to lupus, and that the disease may be triggered by environmental factors like a previous viral infection or exposure to certain chemicals.
    • “Now, a study published Wednesday in the journal Nature outlines a clear pathway for how the disease likely develops, pointing to abnormalities in the immune systems of people with lupus.”
  • Neurology Advisor points out,
    • “The prevalence of stroke has increased by 14.6% from 2011 to 2022 among individuals aged 18 to 44 and 15.7% among those aged 65 and younger in the United States, according to a report published in Morbidity and Mortality Weekly Report.
    • “Researchers assessed trends in stroke prevalence between 2011 and 2022, using data from the Behavioral Risk Factor Surveillance System (BRFSS), a state-based surveillance system administered to noninstitutionalized civilian adults in the US in collaboration with the Centers for Disease Control and Prevention (CDC). * * *
    • “Age-standardized prevalence of stroke increased from 2.7% in 2011 to 2013 to 2.9% in 2020 to 2022, marking a 7.8% (95% CI, 4.9%-10.8%) increase in overall stroke prevalence. The researchers noted the highest stroke prevalence (7.7%; 95% CI, 7.5%-7.9%) among individuals aged 65 and older and the lowest prevalence (0.9%; 95% CI, 0.8%-1.0%) among individuals aged between 18 and 44 years.
    • “Stroke was observed to be highest (5.3%; 95% CI, 4.7%-5.9%) among the American Indian or Alaska Native group and lowest among the Asian group (1.6%; 95% CI, 1.2%-2.0%).
    • “With regard to educational level, individuals with a high-school diploma had the highest stroke prevalence (5.2%; 95% CI, 4.8%-5.4%) and those with a college degree or higher had the lowest stroke prevalence (1.7; 95% CI, 1.6%-1.8%).”
  • STAT News relates,
    • “Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, viruses, excess body weight, alcohol drinking and more. Data was from 2019 in order to avoid the influence of the pandemic, when cancer diagnoses declined because of delayed care. The results were published in the American Cancer Society’s journal, CA: A Cancer Journal for Clinicians.” * * *
    • “In the study, alcohol was associated with seven cancers: oral cavity, pharynx, larynx, colorectum, and female breast, as well as squamous cell carcinoma in the esophagus, and hepatocellular carcinoma in the liver. Beyond those, “there is accumulating evidence” that alcohol can cause other cancers, such as pancreatic cancer, said lead author Farhad Islami, senior scientific director of cancer disparity research at ACS (which funded the study). 
    • “The increased risk is because of the alcohol in alcoholic beverages, not the type of beverage,” he said. A standard alcoholic beverage in the United States has about 14 grams of pure ethanol. That looks like one 12-ounce serving of 5% ABV beer, a 5-ounce serving of 12% ABV wine, 8-10 ounces of 7% ABV hard seltzer, or 1.5 ounces of 40% ABV liquor. Research suggests the higher a person’s consumption, the higher the risk of cancer.”
  • Here is a link to the NIH Director’s blog titled this week “Sequencing Technique Detects Earliest Signs of Genetic Mutations Underlying Cancer, Aging, and More”
  • The National Institutes of Health announced,
    • “Early findings from a small clinical trial provide evidence that a new cellular immunotherapy approach may be effective in treating metastatic solid tumors. In the trial, researchers from the National Institutes of Health (NIH) genetically engineered normal white blood cells, known as lymphocytes, from each patient to produce receptors that recognize and attack their specific cancer cells. These initial findings are from people with metastatic colorectal cancer who had already undergone multiple earlier treatments. The personalized immunotherapy shrank tumors in some patients and was able to keep the tumors from regrowing for up to seven months. The findings were published July 11, 2024, in Nature Medicine.” * * *
    • “Colon cancer is just one of many solid tumors the researchers are studying. The trial is still ongoing and includes patients with different types of solid cancers.
    • “It’s just the very beginning of converting normal lymphocytes into cells capable of treating the common solid cancers,” Dr. Steven A. Rosenberg, a co-leader of the study, said. “What this study shows is that it’s possible. Once you know it’s possible, you work to improve it.”
  • Here is a link to the All of Us Program’s latest Medical Minutes.

From the U.S. healthcare business front,

  • Beckers Hospital Review tells us,
    • “As more older adults opt for Medicare Advantage plans, reimbursement fights between hospitals and insurers are increasingly centered around those contracts.
    • “According to data shared with Becker’s by FTI Consulting, there were 20 reimbursement disputes between hospitals and insurers that made headlines somewhere in the country during the second quarter, the same amount as the first quarter and slightly lower than the same period in 2023, when 24 contract disputes were reported in national or local media.
    • “Notably, a record number of Q2 disputes (15 of 20) involved Medicare Advantage plans, and 30% of disputes failed to reach a timely agreement, meaning tens of thousands of patients were left without in-network coverage. FTI has tracked media reports regarding negotiations over reimbursement rates during each quarter since early 2022.”
  • BioPharma Dive reports,
    • “On Thursday, the pharmaceutical giant [Pfizer] said it is advancing a once-daily version of an experimental and closely watched medicine called danuglipron. Pfizer based the decision on results from a small clinical trial of healthy volunteers that’s been evaluating how the body interacts with danuglipron. Studies designed to find the optimal dose of the medicine are scheduled for later this year.
    • “Umer Raffat, an analyst at the investment firm Evercore ISI, speculates that with its update Thursday, Pfizer is “likely buying time” to see more data from a backup once-daily drug it’s been developing. “Candidly, the trial that just wrapped up never answered the question on” what dose would be effective enough to compete, he wrote in a note to clients.
    • “In that backdrop, the judicious thing to do from [the] Pfizer perspective was to not overcommit — and that’s exactly what they did today,” Raffat added. They “didn’t kill [danuglipron], they said it may move forward, but not right to [Phase 3].”
  • Beckers Payer Issues adds,
    • “As insurers continue to face major financial pressures related to covering weight loss drugs, many are steering more patients toward bariatric surgery to achieve similar results.
    • “Insurance companies are seeing that they’re getting more reliable outcomes and savings in the long run if they pay for someone to have bariatric surgery,” Christine Ren Fielding, MD, told Becker’s. Dr. Ren Fielding is a professor of surgery at NYU School of Medicine, the director of the NYU Langone Weight Management Program and chief of the system’s division of bariatric surgery.
    • “If you’re a responder to appetite control caused by a GLP-1, then there’s another treatment option that will do exactly the same thing: bariatric surgery. That includes Lap-Band, sleeve gastrectomy, and gastric bypass,” she said. “Bariatric surgery is the old-fashioned way. Insurers are now putting up barriers for people who want to be covered for GLP-1s and taking down barriers for people who want to have surgery.”
  • STAT News informs us,
    • “The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant.
    • “The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.”

Monday Roundup

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call lets us know,
    • “Senate Appropriations Committee leaders have agreed to add $34.5 billion in emergency spending to their fiscal 2025 bills on top of levels agreed to in last year’s debt limit negotiations, sources familiar with the talks said Monday. 
    • “Under the pact between Senate Appropriations Chair Patty Murray, D-Wash., and ranking member Susan Collins, R-Maine, defense accounts would receive an extra $21 billion in emergency spending while nondefense programs would get $13.5 billion.” 
  • Taking a gander at reginfo.gov led the FEHBlog to discover that on July 1, the final version of the simply infeasible federal mental health parity rule changes was submitted to OIRA for its review.
  • In yesterday’s post, the FEHBlog called attention to the new CMS GUIDE program. The post noted that program details would be released in early July. What do you know? Those details were posted today. The American Hospital News tells us,
    • “The Centers for Medicare & Medicaid Services July 8 announced over 400 participants in a new model focused on improving dementia care. The Guiding an Improved Dementia Experience (GUIDE) Model began July 1 and seeks to reduce strain on unpaid caregivers as well as offer care coordination and management, caregiver education and support, and respite services. CMS will also test an alternative payment for participants delivering key support services to people with dementia, including comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. People with dementia and their caregivers will have access to a care navigator to help them access services and support, including clinical services and non-clinical services such as meals and transportation through community-based organizations.”
  • The HHS Inspector General posted an impact brief on Medicare Advantage program fraud involving its risk adjustment program. The Wall Street Journal published an article the same type of fraud today.
  • STAT News informs us,
    • “The Biden administration has appealed a decision in which a federal court jury last year sided with Gilead Sciences over the rights to a pair of groundbreaking HIV pills — and at least $1 billion in royalties may be at stake.
    • “At issue is a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
    • “The U.S. Centers for Disease Control, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company refused to reach a licensing agreement despite several attempts to strike a deal.” * * *
    • “U.S. District Court Judge Maryellen Noreika narrowed the Gilead victory last March when she set aside the jury finding that CDC patents were not infringed. So the appeal filed by the U.S. Department of Justice — on behalf of HHS — refers to the only portion of the jury finding that remains, which is that the patents were invalid.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health. The agency is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products.” * * *
    • “Specifically, the revised draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers, sets out a policy that supports companies that issue certain kinds of internet-based communications (“tailored responsive communications”) to address internet-based misinformation about or related to their approved/cleared medical products when that misinformation is created or disseminated by an independent third party. For example, a company might choose to use this type of communication when a celebrity, healthcare provider or influencer, not acting on behalf of the company, posts false, inaccurate and/or misleading representations of fact about the company’s approved/cleared medical product on social media. Additionally, this revised draft guidance provides companies with many examples that illustrate the types of misinformation found online that a company might choose to address with a tailored responsive communication, along with some considerations relevant to the current digital information environment.”
  • Govexec tells us,
    • “The Office of Personnel Management lost a small modicum of ground in its fight to reduce the backlog of pending retirement claims from federal employees as the agency’s backlog of cases inched back over 15,000.
    • “In June, OPM received 6,919 new retirement requests from departing federal workers, a slight increase over the 6,751 claims it received the previous month. But the agency’s pace in processing those claims fell precipitously, completing only 5,614 claims last month compared to the 8,793 it processed in May.
    • “That deficit led to OPM’s overall backlog of pending claims to climb from 14,035—an eight-year low—in May to 15,340 at the end of June. Consequently, the monthly average processing time for a retirement application ticked up four days, from 60 in May to 64 last month, though measured since the beginning of fiscal 2024, the average processing time has remained static at 61 days for four months running.”
  • The U.S. Preventive Services Task Force is celebrating its 40th anniversary. The FEHBlog is reminded that the FEHB Act will be 65 years old on September 28, 2024.

From the public health and medical research front,

  • The New York Times reports,
    • “The process for diagnosing a child with autism heavily relies on a parent’s description of their child’s behavior and a professional’s observations. It leaves plenty of room for human error.
    • “Parents’ concerns may skew how they answer questionnaires. Providers may hold biases, leading them to underdiagnose certain groups. Children may show widely varying symptoms, depending on factors like culture and gender.
    • “A study published Monday in Nature Microbiology bolsters a growing body of research that suggests an unlikely path to more objective autism diagnoses: the gut microbiome.
    • “After analyzing more than 1,600 stool samples from children ages 1 to 13, researchers found several distinct biological “markers” in the samples of autistic children. Unique traces of gut bacteria, fungi, viruses and more could one day be the basis of a diagnostic tool, said Qi Su, a researcher at the Chinese University of Hong Kong and a lead author of the study.”
  • The American Medical Association tells us what doctors wish their patient knew about heat stroke.
  • The Wall Street Journal discusses the right and wrong ways for people to snack.
    • “America is a nation of snackers. A lot of us are doing it wrong. 
    • “Noshing outside of traditional mealtimes isn’t inherently bad. A snack can stave off hunger, boost energy, provide important nutrients and keep us from overeating later. But snacking can also lead us to eat extra calories and overdo it on sodium, added sugars and saturated fats, which can raise our risk of heart disease and obesity. 
    • “How to snack better? Reach for food combinations that keep you fuller longer: Pair carbs like apple slices with protein and fats, like peanut butter. Or try yogurt with berries. Then plan your snack times, and watch out for the minefield that is evening snacking.”
  • The Washington Post and Consumer Reports offer information about “an aggressive tick species spreading across the U.S. Lone star ticks don’t spread Lyme disease, but they can transmit other serious diseases and are linked to a mysterious meat allergy. And the threat is growing.”
    • “Lone star ticks have long been firmly established in the Southeastern United States. In recent decades, however, their numbers have been increasing in Midwestern and Northeastern states. Between 2017 and 2021, according to CDC data, nearly half of reported ehrlichiosis cases were in five states: Arkansas, Missouri, New York, North Carolina and Tennessee.”
  • The CDC has posted FAQs on infertility. “This page has definitions and frequently asked questions related to infertility. It has important information about infertility, including common misconceptions, risk factors, and treatment options.”
  • Beckers Hospital Review points out,
    • “GLP-1 drugs such as Ozempic and Wegovy may lower the risk of developing certain obesity-related cancers, according to a new study from researchers at Case Western Reserve University in Cleveland. 
    • “Researchers found people with type 2 diabetes who were being treated with the medications were significantly less likely to develop 10 of 13 obesity-associated cancers than those taking insulin, according to the findings published July 5 in JAMA Network Open. The retrospective study is based on an analysis of the medical records of over 1.6 million type 2 diabetes patients from 2005 to 2018.
    • “The risk was reduced by more than half for gallbladder cancer, meningioma, pancreatic cancer and hepatocellular carcinoma. Esophageal, colorectal, endometrial, ovarian, multiple myeloma and kidney were among the other cancers for which there was a significant risk reduction. The study did not find a difference in cancer risk reduction among those treated with GLP-1s compared with those taking metformin, an older diabetes drug. 
    • “In an interview with Bloomberg, Arif Kamal, MD, chief patient officer at the American Cancer Society and who was not involved in the research, called the new evidence on GLP-1s “compelling.”
  • Per Fierce Pharma,
    • “In examining the electronic records of more than 18,000 overweight or obese adults in the United States, health data analytics company Truveta found that Lilly’s tirzepatide helped patients lose more weight than Novo’s semaglutide, with the effects growing over time.
    • “Results of the study, which looked at data from May of 2022 and September of 2023, were published Monday in the JAMA Internal Medicine monthly review.
    • “”After use of tirzepatide for three months, patients lost an average of 5.9% of their body weight compared to 3.6% for semaglutide. Over a year’s time, those on tirzepatide lost an average of 15.3% of their body weight compared to 8.3% for semaglutide users.
    • Additionally, tirzepatide patients were much more likely to lose 15% of their body weight than those using semaglutide. While 42% of those on tirzepatide reached the benchmark after one year of treatment, only 18% of those on semaglutide could say the same. 
    • “Lilly’s tirzepatide is the active ingredient found in its diabetes product Mounjaro and its obesity treatment Zepbound, while Novo’s semaglutide is the compound used to make its diabetes blockbuster Ozempic and its obesity follow-on Wegovy.
    • “Importantly, the Truveta study looked at the drugs that are approved for diabetes. The authors noted that “future studies are needed to compare versions labeled for weight loss.”
  • Per an NIH press release,
    • “A series of experiments with highly pathogenic H5N1 avian influenza (HPAI H5N1) viruses circulating in infected U.S. dairy cattle found that viruses derived from lactating dairy cattle induced severe disease in mice and ferrets when administered via intranasal inoculation. The virus from the H5N1-infected cows bound to both avian (bird) and human-type cellular receptors, but, importantly, did not transmit efficiently among ferrets exposed via respiratory droplets. The findings, published in Nature, suggest that bovine (cow) HPAI H5N1 viruses may differ from previous HPAI H5N1 viruses and that these viruses may possess features that could facilitate infection and transmission among mammals. However, they currently do not appear capable of efficient respiratory transmission between animals or people.”
  • MedPage Today lets us know,
    • “Extended-release 7-day injectable buprenorphine was safe and tolerable for most patients who had minimal-to-mild opioid withdrawal, a nonrandomized trial found.
    • “Among 100 adult patients with minimal-to-mild opioid withdrawal scores who were given a 24-mg dose of extended-release buprenorphine, only 10 people (10%, 95% CI 4.9%-17.6%) saw a 5-point or greater jump in withdrawal symptoms within 4 hours of injection, reported Gail D’Onofrio, MD, of the Yale School of Medicine in New Haven, CT, and colleagues.” * * *
    • “The study examined whether patients with untreated opioid use disorder (OUD) and minimal-to-mild withdrawal could tolerate a 7-day dose of buprenorphine. Patients with OUD typically aren’t treated with medication until they are in significant withdrawal, due to fear of precipitated withdrawal. For that reason, “[n]o one has ever even attempted to give buprenorphine in that [0 to 7] range,” D’Onofrio said.” * * *
    • “[This is a real game-changer for emergency physicians and clinicians, even in the clinic, who would be able to induce people on buprenorphine much earlier than they previously could have,” D’Onofrio said.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY has agreed to buy biopharmaceutical company Morphic Holding MORF for $3.2 billion in a deal that bolsters the drugmaker’s immunology pipeline.
    • “Eli Lilly on Monday said it would pay $57 a share for Morphic, a 79% premium to Friday’s closing price of $31.84 for the Waltham, Mass., company.
    • “Morphic is developing therapies for the treatment of serious chronic diseases, with a lead program targeting the inflammatory bowel diseases ulcerative colitis and Crohn’s disease.
    • “Eli Lilly late last year won U.S. Food and Drug Administration approval of its Omvoh treatment for moderately to severely active ulcerative colitis in adults.
    • “Indianapolis-based Eli Lilly said it expects to complete the acquisition, which isn’t subject to any financing conditions, in the third quarter.”
  • Modern Healthcare relates,
    • “More than half of people surveyed would feel just as safe getting hospital-level care at home as they would in a facility, according to the University of Southern California’s Schaeffer Center for Health Policy and Economics.
    • “Healthcare systems across the country are placing big bets on hospital-at-home programs, pushing access to more rural communities and lobbying state Medicaid programs to reimburse for the service. A Centers for Medicare and Medicaid Services waiver reimbursing for acute care at home expires at the end of this year, but bipartisan members of Congress are backing legislation that would provide Medicare reimbursement for another five years. More than 330 hospitals across 37 states offer hospital-level care at-home programs through the CMS Acute Hospital Care at Home waiver.” * * *
    • “The survey did not require participants to have prior experience with hospital-level care at home or knowledge of the service. It did provide participants with a brief explanation of how hospital-at-home programs operate.”
  • Per Fierce Healthcare,
    • “A recent proposal to report prior authorization to insurance plans through CPT codes was withdrawn at the eleventh hour when its physician advocate made an unexpected discovery: For certain codes and in very narrow circumstances, the prior auth requirements were already in place.
    • “Alex Shteynshlyuger, M.D., director of urology with New York Urology Specialists, had previously brought forward a time-based proposal that would ensure physicians are compensated for time spent on prior auth claims. He believed the changes would also reduce the number of claim requirements imposed by plans and limit the amount of appeals and could lead to better patient outcomes.
    • “Following the proposal, however, the American Medical Association (AMA) informed Shteynshlyuger that prior authorization is already explicitly mentioned in official procedure descriptions for half a dozen CPT codes. This required Shteynshlyuger to withdraw the proposal so he could revise and resubmit at a later date.
    • “Each CPT code includes a short description detailing the type of visit or examination. Longer descriptions—where the prior auth mentions were contained—are also stored in databases that can be purchased, but those are rarely encountered.
    • “As a matter of fact, I’ve never seen the long description in my lifetime,” said Shteynshlyuger.”
  • and
    • “Nearly 5 million fewer people delayed care from 2019 to 2022, a study from the Urban Institute with funding from the Robert Wood Johnson Foundation revealed.
    • “The study shows 4.75 million non-elderly Americans skipped necessary medical care, dropping from 12.1% to 9.7% in 2022.
    • “For families below 138% of the federal poverty line, there was a 27% reduction in cost barriers. A 19% reduction was evident for families between 138% and 249% of the federal poverty line.
    • “Researchers say these outcomes are a direct result of the Medicaid continuous coverage requirements and enhanced tax credits.
    • “Our findings show significant improvements in health insurance coverage and healthcare access under federal and state policy changes enacted during the public health emergency,” said Michael Karpman, principal research associate at the Urban Institute, in a statement. “The continued unwinding of the Medicaid continuous coverage requirement and the potential expiration of enhanced Marketplace subsidies after 2025 could make these gains in coverage and access difficult to sustain.”

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.”

Thursday Miscellany

David Ermer–Congress, Electronic health records, FDA, Medical / Rx research, Mental health care, NIH, Obesity, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Happy Summer Solstice in our northern hemisphere of Mother Earth.

From Washington, DC,

  • Federal News Network lets us know,
    • “With both Senate and House lawmakers advancing legislation that aligns with President Joe Biden’s 2% federal pay raise request, civilian federal employees appear to be a step closer to a smaller pay bump for 2025.
    • “The Senate Armed Services Committee’s version of the fiscal 2025 National Defense Authorization Act last week showed support for a 2% raise for DoD civilian workers and a 4.5% raise for military members. In a vote of 22-3 on June 13, committee lawmakers advanced the 2025 NDAA to the full Senate for consideration. The House passed its version of the NDAA last week.
    • “Although the NDAA’s provisions only apply to Defense Department employees, both civilian DoD workers and the rest of the civilian federal workforce on the General Schedule would see the same percentage added to their paychecks, if the raise is enacted.
    • “In House appropriations legislation, committee lawmakers remained silent on the topic of the federal pay raise, indicating a likely alignment with the president’s raise proposal. The GOP-led committee advanced legislation for a fiscal 2025 spending package last week along party lines. The Senate Appropriations Committee has not yet released its versions of fiscal 2025 spending legislation.”
  • The American Hospital Association News tells us,
    • “A United States District Court Judge in Texas today ruled in favor of the AHA, Texas Hospital Association, and hospital plaintiffs, agreeing that Department of Health and Human Services “bulletins” that restrict health care providers from using standard third-party web technologies that capture IP addresses on portions of their public-facing webpages were unlawful final rules and vacating the March 2024 Revised Bulletin.
    • “It’s easy for eyes to glaze over at a thirty-page opinion discussing the administrative esoterica accordant with HIPAA compliance,” United States District Court Judge Mark Pittman wrote today. “But this case isn’t really about HIPAA, the Proscribed Combination, or the proper nomenclature for PHI in the Digital Age. Rather, this is a case about power.…  While the Proscribed Combination may be trivial to HHS, it isn’t for covered entities diligently attempting to comply with HIPAA’s requirements.…  The Court GRANTS the Hospitals’ request for declaratory judgment and DECLARES that the Proscribed Combination, as set forth in the HHS Bulletin of March 18, 2024, is UNLAWFUL, as it was promulgated in clear excess of HHS’s authority under HIPAA.”
  • Bravo!
  • In an interview with Healthcare Dive, Micky Tripathi, the National Coordinator for Health Information Technology, discusses his agency’s artificial intelligence strategy.
  • The House Committee on Education and the Workforce announced that “On Thursday, June 27, at 10:15 a.m., the Subcommittee on Health, Employment, Labor, and Pensions, chaired by Rep. Bob Good (R-VA), will hold a hearing titled “Examining the Policies and Priorities of the Employee Benefits Security Administration.”
  • Kevin Moss, writing in the Federal Times, reminds postal annuitants over the age of 65 and without Medicare Part B about the ongoing, late enrollment penalty free Special Enrollment Period. available to future PSHBP members.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has substantially loosened limits on the first gene therapy for Duchenne muscular dystrophy in a decision that could greatly expand its use even as questions remain about its effectiveness.
    • “The agency on Thursday made the therapy, called Elevidys and sold by biotechnology company Sarepta Therapeutics, available to people with Duchenne who are at least four years of age and have mutations in a specific gene, regardless of whether they can still walk.
    • “For those who are still ambulatory the agency also converted Elevidys’ conditional approval to full, meaning its market availability in that setting is no longer contingent on additional tests. The clearance for Duchenne patients who are non-ambulatory is conditioned on the results of a Phase 3 study called Envision that’s currently underway.”

From the public health and medical research front,

  • Cardiology Business informs us,
    • “The American College of Cardiology (ACC) this week published a report card on the excess cardiovascular mortality among Black Americans between 2000-2022.[1] The ACC said it highlights the “persistent and tragic inequities” in cardiovascular care and outlines the years of life lost to the Black community because of higher cardiovascular disease death rates.
    • “The report showed the Black population experienced 1.6 million excess deaths overall and millions of potential life-years lost. Heart disease was the leading cause of age-adjusted excess mortality among Black Americans. This includes deaths due to ischemic heart disease, hypertension, cerebrovascular disease and heart failure.
    • “Our study reveals that Black Americans, because of their higher cardiovascular mortality rates compared with white Americans, have suffered almost 800,000 excess deaths, which translates to about 24 million additional years of life lost between 2000 and 2022,” Journal of the ACC incoming editor-in-chief Harlan M. Krumholz, MD, SM, FACC, who is also senior author of the study, said in a statement. “This staggering figure highlights the critical need for systemic changes in addressing cardiovascular inequities.”
    • “Krumholz said the goal of the report card is to promote accountability and serve as a catalyst for action that addresses the ongoing problem.”
  • The National Institutes of Health’s Director writes in her blog,
    • “Drug-resistant bacteria are responsible for a rise in serious, hospital-acquired infections, including pneumonia and sepsis. Many of these bacteria are classified as “gram-negative,” and are harder to kill than “gram-positive” bacteria. Unfortunately, the limited number of antibiotics that can help combat these dangerous infections can also damage healthy microbes in the gut, leaving people at risk for other, potentially life-threatening infections. Such antibiotic-induced disruption has also been linked in studies to irritable bowel syndrome, colon cancer, and many other health conditions.
    • “There’s a great need for more targeted antibiotics capable of fending off infectious gram-negative bacteria while sparing the community of microbes in the gut, collectively known as the gut microbiome. Now, in findings reported in the journal Nature , a research team has demonstrated a promising candidate for the job. While the antibiotic hasn’t yet been tested in people, the findings in cell cultures suggest it could work against more than 130 drug-resistant bacterial strains. What’s more, the study, supported in part by NIH, shows that this compound, when given to infected mice, thwarts potentially life-threatening bacteria while leaving the animals’ gut microbiomes intact. * * *
    • “These new findings, while promising, are at an early stage of drug discovery and development, and much more study is needed before this compound could be tested in people. It will also be important to learn how rapidly infectious gram-negative bacteria may develop resistance to lolamicin. Nevertheless, these findings suggest it may be possible to further develop lolamicin or related antibiotic compounds targeting the Lol system to treat dangerous gram-negative infections without harming the microbiome.”
  • Per an NIH press release,
    • “Researchers at the National Institutes of Health (NIH) have developed a non-chemotherapy treatment regimen that is achieving full remissions for some people with aggressive B-cell lymphoma that has come back or is no longer responding to standard treatments. The five-drug combination targets multiple molecular pathways that diffuse large B-cell lymphoma (DLBCL) tumors use to survive.
    • “In a clinical trial at NIH’s National Cancer Institute, researchers tested the combination of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (called ViPOR) in 50 patients with DLBCL, the most common type of lymphoma. The treatment shrank tumors substantially in 26 of 48 (54%) evaluable patients, with 18 (38%) of those patients’ tumors disappearing entirely, known as a complete response. At two years, 36% of all patients were alive and 34% were free of disease. These benefits were seen mainly in people with two specific subtypes of DLBCL.
    • “The findings were published June 20, 2024, in the New England Journal of Medicine.
  • NIH also posted the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)  Director’s Update for Summer 2024.
  • STAT News points out,
    • “Gestational diabetes affects one in seven expecting women globally and rates of this troubling condition are rising. Blood glucose levels that become elevated for the first time during pregnancy can lead to severe complications, such as preeclampsia, and increase the risk of stillbirth. And while the condition typically resolves after birth, it is linked to a tenfold increase in the risk of developing type 2 diabetes, along with risks for the child including obesity, cardiovascular disease, and neurodevelopmental disorders. 
    • “Gestational diabetes has long been diagnosed between weeks 24 and 28 of pregnancy. But a recent randomized control study called Treatment of Booking Gestational Diabetes Mellitus, or TOBOGM, which was started in 2018 and whose results were published earlier this year, found that treating gestational diabetes before week 20 reduced the risk of severe perinatal complications, including preterm birth, low birthweight, stillbirth, and respiratory distress. The early treatment was most effective in women who had high blood glucose levels after an oral glucose tolerance test, which measures how well the body can metabolize the sugar in a very sweet, Gatorade-like drink. 
    • “In some cases, women are tested early when they have risk factors such as high blood pressure, obesity, or previous gestational diabetes. But between 30% and 70% of all gestational diabetes cases could be detected much earlier — by the twentieth week of a pregnancy, according to a series published on Thursday in The Lancet by an international group of gestational diabetes researchers.” 
  • and
    • When they work, immunotherapy drugs called checkpoint inhibitors can shrink cancers and, in some cases, eradicate tumors altogether. These drugs, which include Keytruda and Opdivo, are prescribed to hundreds of thousands of patients a year for dozens of different kinds of cancer — but they only work for a minority of them. Most patients ultimately end up progressing or relapsing.
    • In two separate [small] clinical trials published in Science on Thursday, researchers found that adding a drug called a JAK inhibitor created an unexpected synergy with checkpoint inhibitor therapy. The combination helped a majority of patients respond to the immunotherapy and, in one trial, overcome resistance to checkpoint inhibitors.
  • Per Biopharma Dive,
    • “Twice-yearly shots of a Gilead Sciences HIV drug were so effective at preventing infections in a large late-stage clinical trial that study monitors recommend the company stop testing early and offer the drug to all participants.
    • “The trial, called Purpose 1 and run in South Africa and Uganda, compared Gilead’s medicine lenacapavir to once-daily Truvada and background HIV infection rates among cisgender women. Lenacapavir proved superior to both, with zero HIV infections reported in the study group, Gilead said Thursday.
    • “Gilead hopes testing of twice-yearly lenacapavir will prove it an effective and more convenient preventive option for people at risk of HIV infection. The company expects data late this year or early next from another study that involves cisgender men who have sex with men as well as certain groups of people who are transgender or gender non-binary.”
  • Optum discusses “New innovative treatments for hemophilia B, RSV, COPD” in its new edition of its Drug Pipeline Insights Report.
  • Per Medscape,
    • “A single course of treatment with emotional awareness and expression therapy (EAET) was associated with a significantly greater reduction in chronic pain severity than cognitive-behavioral therapy (CBT), the current psychotherapeutic gold standard, a new study suggested.”
    • “Two thirds of the patients who received EAET reported at least a 30% reduction in pain compared with 17% of those who received CBT. The randomized clinical trial also showed that individuals with depression and anxiety responded more favorably to EAET, a novel finding.
    • The study is one of only a few to directly compare EAET with CBT.”

From the U.S. healthcare business front,

  • Mercer Consulting notes,
    • “Despite higher healthcare cost trends, fewer than half of large employers (those with 500 or more employees) are likely to take cost-cutting measures next year like raising deductibles or copays, according to Mercer’s new Survey on Health and Benefit Strategies for 2025, with nearly 700 employer participants.
    • “Heading into 2025, employers face the challenge of addressing sharply faster cost growth while keeping healthcare affordable for their workers and offering a competitive benefit package. The survey found that medical plan options that save money by steering employees to quality, cost-efficient health providers — and potentially offer members more affordable coverage – now have significant traction with employer health plan sponsors.
    • “These plans take different forms, but over a third of large employers (36%) are now utilizing high-performance network plans or other alternative medical plans, and 29% are considering it in the near-term. * * *
    • “Many large employers indicated they want a consistent offering nationally. If this is a key priority, then an employer could explore the newer variable copay health plan options or high-performance network products offered by certain national carriers that can backfill with their broad network as needed in some geographies for a consistent national offering. Further, while considering disruption to members is important, it shouldn’t mean avoiding change entirely. A high-performance network option could be offered as a choice at enrollment that provides a richer benefit design or lower payroll contribution option as a tradeoff for the different network.
    • “Additionally, the prevalent variable copay plan options are built on top of national broad network options, so in most cases provider disruption would be minimal.
  • Newfront discusses ten spousal incentive HRA compliance considerations. Spousal incentive HRAs are health reimbursement accounts offered to employees who elect primary coverage from their spouse’s group health plan.
  • Beckers Payer Issues relates,
    • “Humata Health, a company that uses AI and machine learning to streamline prior authorization for payers and providers, has closed a $25 million investment. 
    • “The funding was led by Blue Venture Fund (majority of BCBS plans) and LRVHealth (nearly 30 health systems and payers), with participation from Optum Ventures, .406 Ventures, Highmark Ventures and VentureforGood, according to a June 20 news release.
    • “The company said it will use the funding to broaden the scope of its generative AI technologies, expand its customer base, and begin partnering with payers and other entities. Founded in 2023, the company has already partnered with 225 hospitals.”
  • The Wall Street Journal reports,
    • “Eli Lilly is stepping up its campaign against fake and counterfeit weight-loss drugs with more lawsuits against sellers of unapproved products that market themselves as Mounjaro and Zepbound.
    • “The pharmaceutical company said Thursday that it has filed legal actions against med-spas, wellness centers and other entities that sell products purportedly containing tirzepatide, the antidiabetic medication Eli Lilly sells under the brand names Mounjaro and Zepbound.”
  • STAT News interviews Bold Health’s CEO Amanda Rees on “fall prevention, ageism in health care, and ‘movement is medicine’.”
    • “When Amanda Rees was in her twenties she moved in with her grandmother, who was in her 80s, and saw first-hand the issues older adults face with falls and balance. “It really radicalized how I thought about aging,” she said. Serving as her grandmother’s caretaker inspired her to shift into health care and start Bold, a health tech startup that provides at-home digital exercise programs targeted at adults 65 and older.  
    • “Falls among older adults cost the health care system about $50 billion annually, according to the CDC. Rees hopes Bold can help older adults build strength, prevent falls and reduce hospitalizations. The Los Angeles-based startup works with Medicare Advantage members and raised $17 million during its Series A. Rees sat down with STAT to discuss building Bold, the concept of  “movement is medicine,” and the public health crisis of falls.”

Monday Roundup

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The U.S. Office of Personnel Management recently posted new Postal Service Health Benefits Program FAQs concerning its May 2024 proposed rule supplementing existing guidance on that program. The public comment period on that proposed rule is next Monday June 24.
    • Here’s an FAQ on a point that the FEHBlog mentioned but he has not seen in any other publication:
      • 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. An individual who opts out of or disenrolls from the Part D EGWP would be allowed to enroll again during the next open season or an applicable Qualifying Life Event (QLE) if they wish.
  • Federal News Network tells us,
    • “While years in the making, the Office of Personnel Management’s upcoming plans to try to cut down on unneeded health insurance costs will also arrive to open arms from the Government Accountability Office.
    • “Beginning in 2025, OPM is adding stricter eligibility requirements to try to root out ineligible enrollees in the Federal Employees Health Benefits (FEHB) program — something that’s been high on GAO’s radar for at least the last few years. A 2022 GAO report showed that OPM spends up to $1 billion each year on ineligible participants erroneously enrolled in FEHB.
    • “One of the biggest benefit systems in the country, and for decades, nobody checked these things,” Comptroller General Gene Dodaro told lawmakers on the House Oversight and Accountability Committee during a June 13 hearing. * * *
    • “Current FEHB eligibility determination and enrollment is highly decentralized and requires cooperation between nearly 100 employing offices responsible for determining eligibility and enrolling more than 8 million members,” OPM said in April. “If funded, OPM could extend this same central enrollment system to all FEHB enrollments, which would allow OPM to manage and make consistent all FEHB enrollments and remove individuals who cease to be eligible for the program.”
    • “OPM, as part of its fiscal 2025 budget request, is proposing legislation to build a centralized enrollment system for FEHB. With a central database, OPM would be able to more quickly address the problem and avoid the spending errors. That system, if it’s implemented, would be modeled after the centralized system OPM just recently built for the upcoming Postal Service Health Benefits program.”
      • FEHBlog note — While all of this is welcome progress, the most glaring, and as yet unresolved, internal control issue is that OPM reports enrollment and premiums to carriers separately rather than using the HIPAA standard electronic enrollment roster transaction 820 which would allow carriers to reconcile each enrollee with his or her premium payments. Carriers are entitled to this reconcilable information because they hold the insurance risk on these plans. Moreover, shouldn’t we make sure that the enrollee is paying the correct premium before checking family member eligibility?
  • The New York Times reports,
    • “The U.S. surgeon general, Dr. Vivek Murthy, announced on Monday that he would push for a warning label on social media platforms advising parents that using the platforms might damage adolescents’ mental health.
    • “Warning labels — like those that appear on tobacco and alcohol products — are one of the most powerful tools available to the nation’s top health official, but Dr. Murthy cannot unilaterally require them; the action requires approval by Congress.”
  • STAT News adds,
    • “His call to action on Monday was more strident, garnering praise from advocates of stricter social media controls, especially for young people. “Yes, this is a consumer product that is unsafe for children and teens,” wrote NYU social psychologist Jonathan Haidt, a strong proponent of limiting phone time, on X.
    • “But for several experts operating in this field, the type and extent of social media harm exacted on children isn’t quite as clear as Murthy seems to suggest. Indeed, said Michaeline Jensen, a psychologist at the University of South Carolina, Greensboro, there isn’t sufficient evidence to conclude social media is safe — but there isn’t enough to conclude the opposite, either.
  • STAT News also lets us know,
    • “The Food and Drug Administration on Monday approved Merck’s new pneumococcal vaccine for adults 18 and older.
    • “The vaccine, which will be sold under the name Capvaxive, is designed to protect against pneumococcal pneumonia, which hospitalizes about 150,000 adults in the United States every year and kills about 1 in 20 who develop it, according to the National Foundation for Infectious Diseases. * * *
    • “Before Capvaxive can be put into use, it must receive a recommendation from the CDC. The Advisory Committee on Immunization Practices, which advises the CDC on vaccination policy, meets next week for one of its three regularly scheduled meetings. A draft agenda for the meeting shows that a vote on Capvaxive is scheduled for Thursday, June 27.”
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services announced on Monday that is gearing up to end a program that offered financial assistance to providers impacted by the cyberattack on Change Healthcare.
    • “The agency said that the accelerated and advance payment program launched in response to the hack will end on July 12. The initiative sought to ease cash-flow disruptions that were caused by the cyberattack.

From the public health and medical research front,

  • STAT News reports,
    • “The hope for many cancer patients who go through surgery is that they’ll be cured after the surgeon removes the tumor. The question that lingers is whether they got it all out — if the surgery happened in time before cancer cells scattered off of the primary tumor to seed unseen metastases or if some microscopic malignancy was left behind near the original cancer site.
    • “To answer this question, clinicians are increasingly turning to blood tests that detect circulating tumor DNA, known as ctDNA. The idea is that finding tumor DNA in the blood probably means that cancer cells are still growing somewhere in the body, even at a low level. These tests are starting to be used in a variety of cancers — and for the most part, clinicians agree that if the test is positive, the cancer will likely recur. The trouble is that scientists aren’t sure what should happen next.
    • “We are all recognizing that if a patient has detectable circulating tumor DNA, it’s not a question of if the cancer’s coming back, but when,” said Van Morris, a gastrointestinal medical oncologist at MD Anderson Cancer Center. “The field recognizes the power of this tool, but I think there remain many questions of how best do we utilize that in the day-to-day management of patients.”
    • “Some of those questions include whether clinicians should step up the intensity of treatment if patients are positive for ctDNA, whether they should step down treatment if patients are negative for ctDNA, or how long they should treat patients. And if you do any of these things, it’s still not clear if that would have any meaningful impact on patients’ overall survival or quality of life in most settings. The only way to answer these questions will be by confirming hypotheses in prospective randomized trials, which are ongoing.”
  • Per BioPharma Dive,
    • “New data showcase promise, growing pains of CAR-T in autoimmune disease.
    • “While one expert described clinical trial results to date as “unprecedented,” reports of relapses in some patients drew questions about the therapies’ ultimate potential.”
  • The Washington Post and Consumer Reports points out,
    • “Five diet changes that can help lower blood pressure.
    • “Adding potassium and cutting back on alcohol can help reduce the need for meds if you have hypertension, or even prevent it in the first place.”
  • The Washington Post reports,
    • “Born last November, Fern had blood drawn from her heel for North Carolina’s mandatory newborn screening, which tested for more than 60 medical conditions. Nothing was found. That could have been the end of the story. Instead, Tiffany and her husband, Matthew Vogt, a physician and scientist in Durham, decided to take the nonprofit research institute RTI International up on a groundbreaking offer.
    • “Free of charge, parents in North Carolina can have experts conduct a more extensive scan and review their baby’s entire genetic blueprint for 200 different conditions. One is Pendred syndrome, a condition not covered by the standard, more limited newborn screening.
    • “Researchers in North Carolina and New York are studying whether this far more comprehensive approach can save lives and improve children’s health. Two decades after scientists sequenced the first human genome, the two studies reflect the rapid emergence of a new kind of health care called genomic medicine, spawned by that landmark achievement.
    • “Early results show that genome sequencing is identifying conditions not disclosed through the traditional newborn screening required by all 50 states. Since the study in North Carolina began in September 2023, researchers have examined the genomes of more than 1,800 babies; 40 were deemed likely to have medical conditions that were not previously diagnosed. One newborn was flagged as likely to have two previously undiagnosed conditions.
    • “Some of those were for potentially life-threatening conditions,” said Holly Peay, lead investigator for the Early Check program led by RTI International.
    • “Since launching the GUARDIAN program with its collaborators in September 2022, New York State has sequenced the genomes of more than 10,000 babies; 299 tested positive for one of the 450 conditions the state has focused on.
    • “For one child, it was even lifesaving,” said Wendy Chung, head of pediatrics at Boston Children’s Hospital, who is leading New York’s study.”
  • The National Institutes of Health announced,
    • “The prevalence of chronic hypertension in pregnancy in the United States doubled from 2007-2021, but only about 60% of those with the potentially life-threatening condition were treated with antihypertensive medications, according to a National Institutes of Health (NIH)-supported study of nearly 2 million pregnancies. The study, which was funded by NIH’s National Heart, Lung, and Blood Institute (NHLBI), did not explore the reasons for the increase, but rising maternal age, growing obesity rates, and other factors likely played a role, according to researchers. The findings were published today in the journal Hypertension.
    • “These findings are deeply concerning because of the high rate of U.S. maternal mortality, which is linked to chronic hypertension in pregnancy,” said study lead Stephanie Leonard, Ph.D., an epidemiologist at Stanford University School of Medicine in California. “Despite the availability of safe and effective treatments for chronic hypertension, the study speaks to an urgent need for improvement in care for this serious condition.” * * *
    • “To manage hypertension during pregnancy, experts recommend that women check their blood pressure at home and keep it under control, visit with a doctor often, and take antihypertensive medications as prescribed.”
  • Per a Substance Abuse and Mental Health Services Administration press release,
    • “Researchers from the Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA), Centers for Medicare & Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC) found that among a cohort of 137,000 Medicare beneficiaries who experienced a nonfatal overdose in 2020, almost 24,000 (17.4%) experienced a subsequent nonfatal overdose, and about 1,300 (1%) died from overdose in the following year. Results were published today in JAMA Internal Medicine, identifying both effective interventions and significant gaps in care.
    • “People who have experienced one overdose are more likely to experience another,” said Miriam E. Delphin-Rittmon, Ph.D., HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “But we found that when survivors received gold-standard care such as medications for opioid use disorder and naloxone, the chances of dying from an overdose in the following year drop dramatically. In short, medications for opioid use disorder, opioid overdose reversal medications, and behavioral health supports save lives.”
    • “The study identifies effective, lifesaving interventions following initial nonfatal overdoses. The odds of dying from a subsequent lethal overdose decreased among cohort members who received methadone (58% lower odds), buprenorphine (52% lower odds), or behavioral health assessment or crisis services (75% lower odds). The risk of overdose mortality among those who filled a prescription for naloxone was also reduced by 30%.
    • “However, significant gaps in care were also noted. Only 4.1% of the cohort received medications for opioid use disorder (MOUD), and only 6.2% filled a prescription for naloxone, commonly known as Narcan, despite these being gold-standard interventions. Beneficiaries receiving MOUD waited a mean of 72 days between their nonfatal overdose and receiving medication.”
  • STAT News reports,
    • “E-cigarettes were about as effective at helping people quit smoking as the gold-standard pharmaceutical drug, varenicline, according to a clinical trial published Monday in JAMA Internal Medicine.
    • “The trial randomized 458 people who smoked daily and wanted to quit to receive either a nicotine-containing e-cigarette and placebo tablets, varenicline and an e-cigarette without nicotine, or a placebo tablet and a nicotine-free e-cigarette for 12 weeks. All three groups were also given intensive tobacco cessation counseling.
    • “After 26 weeks, roughly equal percentages of participants using varenicline and e-cigarettes — 43.8 percent and 40.4 percent, respectively — had stopped smoking. The difference in quit rates between the two groups was not statistically significant.
    • “The JAMA study is the first published randomized controlled trial to compare varenicline, also known as Chantix, directly to e-cigarettes. Several studies have demonstrated that e-cigarettes can help adults quit smoking. However, most studies have compared e-cigarettes to placebo alone, or to nicotine replacement therapy, such as patches and lozenges, which help smokers manage their withdrawal symptoms.
    • “The trial is likely to cause a stir within the tobacco-control community, which has been bitterly divided over the question of whether e-cigarettes are a help or hindrance for adults who smoke cigarettes, and whether they should be recommended by doctors as a way to kick a smoking habit. While countries like the United Kingdom actively encourage smokers to use these products to help them quit cigarettes, nations including the United States and Japan have been far more conservative. Backers of e-cigarettes say this study shows the U.K. has the right idea.”

From the U.S. healthcare business front,

  • In Medicare Advantage STAR ratings news, Modern Healthcare tells us,
    • “Nonprofit health insurance companies historically have outperformed for-profit competitors on star ratings and could be disadvantaged when their rivals are boosted, but the Alliance of Community Health Plans doesn’t see a concern.
    • “It is equitable that plans that are going to have their scores recalculated for ’24 and have a change in their revenue have a chance to modify their ’25 bids because they were at a different place when they submitted it,” said Michael Bagel, associate vice president of public policy at the trade group for nonprofit insurers.
    • “Allowing only insurers that get increased scores to resubmit bids could provoke lawsuits, Meekins said. “There’s still the potential for legal challenges to that because there’s a bit of game theory that goes into the bid process and what you think other people are going to do,” he said.
    • “CMS has not said how it will handle star ratings for 2025, whether it will reinstitute the methods the courts overturned on technical grounds or whether it will appeal the Elevance Health and SCAN Health Plan decisions.”
  • Beckers Hospital Review identifies “37 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2024.”
  • Fierce Healthcare offers a special report naming “the top 10 nonprofit health systems by 2023 operating revenue.”
  • MedCity News relates
    • “Retailers are facing several headwinds in healthcare in 2024. Walmart and Dollar General both recently ended healthcare endeavors, and CVS Health is reportedly looking for a private equity partner for Oak Street Health (which it acquired in 2023). VillageMD, which is backed by Walgreens, is shuttering numerous clinics.
    • “Still, Mary Langowski, executive vice president and president of U.S. healthcare at Walgreens Boots Alliance, sees a strong future for retailers in healthcare.
    • “I happen to be very bullish on the role of retail in healthcare and frankly, having a very central role in healthcare,” she said. “And part of that is because over 80% of people want health and wellness offerings in a pharmacy and in a retail setting. Consumers want the ease, they want the convenience of it. And those are important things to keep in mind, that demand is there.”
    • “Langowski, who joined Walgreens in March, made these comments during a Tuesday fireside chat at the AHIP 2024 conference held in Las Vegas. She added that what the industry is seeing is not an “evolution” of whether retailers will exist in healthcare, but a shift around what the “right model is going to be.” 
  • The Washington Post notes,
    • “If your doctor can’t see you now, maybe the nurse practitioner can.
    • “Nurse practitioners have long been a reliable backstop for the primary-care-physician shortfall, which is estimated at nearly 21,000 doctors this year and projected to get worse.
    • “But easy access to NPs could be tested in coming years. Even though nearly 90 percent of nurse practitioners are certified to work in primary care, only about a third choose the field, according to a recent study.
    • “Health-care workforce experts worry that NPs are being lured toward work in specialty practices for the same reason that some doctors steer clear of primary care: money.”


Weekend Update

David Ermer–CDC, Congress, COVID-19, Medicare, NIH, U.S. Healthcare–

From Washington, DC,

  • Last Thursday, June 13, the House Appropriations Committee met to consider “Fiscal Year 2025 Financial Services and General Government Appropriations Act.” The measure was approved by the Committee with a vote of 33 to 24. The Committee adopted an amendment that “Requires the Office of Personnel Management (OPM) to submit a report on the coverage options currently available to federal employees that include assisted reproductive technology services and procedures.” 
  • Healthcare Dive tells us,
    • “Members of Congress are questioning the CMS Innovation Center’s progress in moving the nation’s health system to value-based care after a report found the center has increased federal spending instead of lowering it.”
    • “The Center for Medicare and Medicaid Innovation, or CMMI, was created by the Affordable Care Act more than a decade ago. The center is tasked with testing new healthcare payment and delivery models to lower costs and improve quality in government health programs.
    • “However, during at House Energy and Commerce subcommittee hearing on Thursday, some lawmakers — particularly Republicans — stressed that CMMI has failed to save money during its first 10 years and could continue to increase spending over the next decade. * * *
    • “Some legislators raised concerns about a lack of provider input into CMMI models. But a new strategic direction for CMMI, announced in 2021, should improve transparency and lay out the center’s priorities, Fowler said.
    • “Many stakeholders, including healthcare providers and various industry stakeholders, have expressed concern about the complexity, administrative burden and perceived lack of transparency involved when participating in the CMMI models,” said Rep. Bob Latta, R-Ohio.”
  • The American Medical Association lets us know,
    • “Just months after Congress again failed to stop in its entirety a pay cut that threatens Medicare patients’ access to high-quality physician care, the AMA House of Delegates made crystal clear the imperative to step up the pressure on the nation’s lawmakers and boost patient awareness about the dire need for Medicare payment reform.
    • “In a federal budget deal struck to continue operating the government, Congress in March reduced to less than 2% the 3.37% across-the-board physician pay cut that took effect in January.
    • “The House of Delegates (HOD) directed the AMA to:
      • “Increase media awareness around the 2024 AMA Annual Meeting about the need for Medicare payment reform, eliminating budget-neutrality reductions, and instituting annual cost-of-living increases.
      • ‘Step up its public relations campaign to get more buy-in from the general public about the need for Medicare payment reform.
      • “Increase awareness to all physicians about the efforts of our AMA on Medicare payment reform.
      • “Advocate for abolition of all Merit-based Incentive Payment System (MIPS) penalties in light of the current inadequacies of Medicare payments.
    • “This direction from the HOD bolsters the AMA’s aggressive efforts in leading the charge to reform the Medicare payment system.

From the public health and medical research front,

  • The Hill takes a look at the CDC’s current Covid statistics. Here’s the sentence that grabbed the FEHBlog’s attention: “[H]ospitalizations for COVID-19 remain very low nationwide. Only 0.6% of all emergency department visits were diagnosed as COVID cases last week.
  • A Buffalo, NY, television station WGRZ offers tips on how to reduce the risk of falling as you age, which is useful information for FEHB plans to share given the FEHB’s older demographics.
  • The National Institutes of Health announced today,
    • A data-driven intervention that engaged communities to rapidly deploy evidence-based practices to reduce opioid-related overdose deaths – such as increasing naloxone distribution and enhancing access to medication for opioid use disorder – did not result in a statistically significant reduction in opioid-related overdose death rates during the evaluation period, according to results(link is external) from the National Institutes of Health’s HEALing (Helping to End Addiction Long-Term) Communities Study. Researchers identified the COVID-19 pandemic and increased prevalence of fentanyl in the illicit drug market – including in mixtures with cocaine and methamphetamine – as factors that likely weakened the impact of the intervention on reducing opioid-related overdose deaths.
    • The findings were published in the New England Journal of Medicine and presented at the College on Problems of Drug Dependence (CPDD) meeting on Sunday, June 16, 2024. Launched in 2019, the HEALing Communities Study is the largest addiction prevention and treatment implementation study ever conducted and took place in 67 communities in Kentucky, Massachusetts, New York, and Ohio – four states that have been hard hit by the opioid crisis.
  • STAT News promptly followed up with an article about this NIH announcement.
    • “In statements, federal health officials cast the study as at least a partial victory. While the interventions did not meaningfully reduce overdose deaths, the officials argued, they set the stage for future action and created a framework to help hard-hit communities choose new policy approaches and begin to implement them, with the hope that with more time and without Covid-19, deaths would fall.  “In statements, federal health officials cast the study as at least a partial victory. While the interventions did not meaningfully reduce overdose deaths, the officials argued, they set the stage for future action and created a framework to help hard-hit communities choose new policy approaches and begin to implement them, with the hope that with more time and without Covid-19, deaths would fall.  
    • “[Nora] Volkow, the NIDA director, said that increasing use of stimulants like methamphetamine and cocaine, and the proliferation of fentanyl, mean society must “continue developing new tools and approaches” for preventing overdose deaths. Miriam Delphin-Rittmon, the administrator of the Substance Abuse and Mental Health Services Administration, said the study “recognizes there is no quick fix.” 
    • “And in an interview, [Redonna] Chandler, the director of the study, stressed that the results should not challenge what research has long demonstrated: There is a “mountain of evidence,” she said, supporting the belief that tools like naloxone, medications for opioid use disorder, and safer prescribing techniques, save lives. The challenge, Chandler said, lies in implementation — not the strategies themselves. 
    • “The study released Sunday, she said, “doesn’t negate, in any way, the evidence that suggests the strengths of those interventions.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington DC,

  • Federal News Network lets us know,
    • “For federal employees, a bill pending in the Senate would bring expanded coverage of fertility treatments through the Federal Employees Health Benefits (FEHB) program.
    • “But the Right to IVF Act, which Sens. Tammy Duckworth (D-Ill.), Patty Murray (D-Wash.) and Cory Booker (D-N.J.) introduced last week, did not garner the 60 votes needed to move forward with a floor vote Thursday afternoon. Almost all Republicans voted against the measure to advance the legislation, resulting in a 48-47 tally.
    • “The legislation rolls together three previous bills all aiming to improve access and insurance coverage for in-vitro fertilization (IVF). In part, the bill would have impacts specifically on FEHB enrollees. One component of the Right to IVF Act aims to set higher requirements for FEHB carriers to offer IVF coverage.
    • “The Office of Personnel Management increased FEHB carrier requirements for IVF treatments for plan year 2024. But the legislation looks to further extend the requirements of IVF to cover both treatments and medications, as well as expanding to more types of assisted reproductive technology (ART).”
  • Many large FEHB plans cover ART procedures. Competition will cause other plans to follow their lead.
  • Federal News Network also identifies House of Representatives policy riders to FY 2025 appropriations bills that are relevant to federal employees and their benefit programs.
  • The American Hospital Association News relates,
    • “The House Energy and Commerce Health Subcommittee June 13 held a hearing about transitioning to value-based care. The AHA submitted a statement to the subcommittee for the hearing, expressing support for value-based care and sharing principles the Center for Medicare and Medicaid Innovation should consider when designing alternative payment models. Those principles include adequate on-ramp and glidepath to transition to risk; adequate risk adjustment; voluntary participation and flexible design; balanced risk versus reward; guardrails to ensure participants don’t compete against themselves when they achieve optimal cost savings and outcomes; and upfront investment incentives.” 
  • Healthcare Dive informs us,
    • “The Supreme Court on Thursday unanimously ruled an anti-abortion group contesting the Food and Drug Administration’s approval of the abortion pill mifepristone does not have a legal basis to sue, putting an end to a drawn-out and high-profile court battle.
    • “The court held the plaintiffs’ “desire to make a drug less available to others” did not give them standing to challenge the FDA’s actions around mifepristone.
    • “The plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact,” Justice Brett Kavanaugh wrote in the court’s opinion. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
  • The Wall Street Journal adds,
    • “An appeals panel [in August 2023] rolled back much of the [district court’s] ruling, saying it was too late to challenge the drug’s original approval. But the appeals court did find that the plaintiffs had standing to sue, and it ruled the FDA’s efforts beginning in 2016 to make the pill more available were unlawful. The Supreme Court had previously put that ruling on hold, preserving the status quo of widespread mifepristone access while it considered the case. * * *
    • “The pill case won’t be the last time the justices weigh in on abortion access this term. The court in the next couple of weeks is expected to decide a separate case out of Idaho that centers around the question of whether a federal law that requires hospitals to provide stabilizing care for patients at risk of death or serious injury trumps state abortion bans that allow doctors to perform the procedure only if a woman’s life is in jeopardy.”
  • STAT News notes,
    • “Both President Biden and former President Trump love to claim credit for getting more Americans $35 insulin.
    • “But the credit should actually go to a giant pharmaceutical company — just the type that both men claim to have challenged.
    • “Eli Lilly, an $800 billion pharma giant and one of three insulin manufacturers in the United States, first proposed an experiment allowing Medicare insurance plans to offer $35 monthly insulin in 2019, CEO David Ricks and former Medicare agency chief Seema Verma said in interviews with STAT.
    • “It is true. We approached CMS with that idea,” Ricks said, referring to the government Medicare agency.
    • “Verma gave Ricks credit. “He is an unsung hero. He was actually the mastermind of all of this,” she said.”
  • Per Department of Health and Human Services press releases,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded more than $11 million to 15 organizations to establish new residency programs in rural communities. HHS Secretary Xavier Becerra and White House Domestic Policy Advisor Neera Tanden announced the new awards while visiting rural health clinic in Wisconsin Rapids, Wisconsin today. Building on HRSA’s Enhancing Maternal Health Initiative, one program will create the first obstetrics and gynecology Rural Track Program in the country, and six others will develop new family medicine residency programs with enhanced obstetrical training in rural communities.”
    • “For more information about the Rural Residency Planning and Development Program, visit https://www.hrsa.gov/rural-health/grants/rural-health-research-policy/rrpd.”
  • and
    • “The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is announcing up to $500 million in Project NextGen funding to plan and execute multiple Phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.
    • “We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” said HHS Secretary Xavier Becerra. “We are making progress on the development of cutting-edge treatments, such as vaccines administered as a nasal spray or as a pill. The Biden-Harris Administration won’t stop until we have the next generation of innovative vaccines, therapeutics, and other tools to protect against COVID-19, or any other pathogen that could threaten the American public.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Avoid raw milk. Lay off cheeses made with unpasteurized milk. And cook your beef to medium- or well-done temperatures.
    • “These are the precautions that public health officials and doctors recommend as they track the H5N1 bird flu outbreak in U.S. cattle. Ten states have H5N1 outbreaks in cows, according to the Centers for Disease Control and Prevention, and at least three U.S. dairy farmworkers have been diagnosed with bird flu. 
    • “A man in Mexico contracted a different strain of bird flu—H5N2—earlier this month and died, though he died from underlying conditions, according to the Mexican government.
    • “Doctors and federal officials say the public health risk of getting H5N1 is currently very low unless you work on a farm, and stress that there has been no evidence of human-to-human transmission. What’s raised concern is that the most recent case—found in a dairy worker in Michigan earlier this month—had respiratory symptoms unlike the previous two cases where the primary symptom was pinkeye. 
    • “Viruses with respiratory symptoms are more contagious and transmissible than conjunctivitis, or pinkeye, so doctors and scientists say they are watching closely. For now, it has been more than a week since the worker tested positive and there have been no known cases of transmission.”  
  • The NIH director in her weekly blog tells us,
    • We know stress can take a toll on our mental health. Yet, it’s unclear why some people develop stress-related mental health disorders and others don’t. The risk for developing a stress-related mental health disorder such as post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) depends on a complex interplay between the genetic vulnerabilities we are born with and the impact of traumatic stress we experience over our lifetimes.
    • Given this complexity, it’s been difficult for researchers to pinpoint the underlying biological pathways in the body that ultimately produce changes associated with PTSD, major depression, or other mental health conditions. Now, a study reported in a special issue of Science on decoding the brain uses a comprehensive approach to examine multiple biological processes across brain regions, cell types, and blood to elucidate this complexity. It’s an unprecedented effort to understand in a more holistic way the essential biological networks involved in PTSD and MDD. * * *
    • “There’s clearly much more to discover in the years ahead. But these insights already point to important roles for known stress-related pathways in fundamental brain changes underlying PTSD and MDD, while also revealing more novel pathways as potentially promising new treatment targets. With further study, the researchers hope these findings can also begin to answer vexing questions, such as why some people develop PTSD or major depression after stressful events and others don’t.”
  • STAT News points out that “With placenta-on-a-chip, researchers hope to gauge how drugs and toxins impact pregnancy.”
    • “[Mechanical engineer Nicole] Hashemi and her colleagues received a three-year, $350,000 grant from the National Science Foundation to advance their current placenta-on-a-chip model. They plan on designing systems that can be integrated into the model to help collect data in real time. Hashemi told STAT that one system could look at changes in the shapes of cells when exposed to chemicals or physical stressors.
    • “The placenta-on-a-chip technology is simple but potentially powerful, and similar efforts are being made to replicate the environments of other human organs. The small chip is usually about the size of a rubber eraser, etched with tiny channels through which fluids move — offering a simplified, functional model of an organ to test drugs or to study the progression of disease. Researchers can grow cells and run fluids that act like blood through chambers in the chip to create environments similar to those in the human body.
    • “According to Dan Huh, a professor of bioengineering at the University of Pennsylvania and a leader in developing many organs-on-a-chip including the placenta and lung, maintaining the environment is almost like tricking the cells into thinking that they’re still in the body so that they “do what they’re supposed to do.”
  • MedPage Today tells us,
    • “Disrupted access to prescription stimulants for patients with attention deficit-hyperactivity disorder (ADHD) may increase risks of injury or overdose, the CDC warned on Thursday following the indictment of an online ADHD medication prescriber over fraud allegations.
    • “Several ADHD stimulants such as immediate-release amphetamine (Adderall) are already in shortage, and the new federal healthcare fraud indictment may further disrupt care for as many as 50,000 patients with ADHD, the CDC detailed.
  • The Journal of the American Medical Association released a research letter about trends in Naloxone dispensing from U.S. retail pharmacies.
    • “Naloxone prescriptions dispensed from retail pharmacies increased from 2019 to 2023, with the largest single-year increase observed in 2022. This increase may reflect efforts to expand naloxone prescribing, including state-level standing orders3 and clinical practice guidelines. Although statistically significant increases were observed among most prescriber specialties between 2019 and 2023, nearly two-thirds of dispensed naloxone was prescribed by advanced practitioners and primary care specialties in 2023. Continued efforts such as evidence-based academic detailing and electronic health record alerts can support clinicians in prescribing naloxone.
    • “The observed decrease in retail pharmacy–dispensed naloxone prescriptions during Q3 and Q4 2023 may be due to naloxone becoming available over the counter,4 though trend analysis indicated the decline was not statistically significant. Studies have found that over-the-counter naloxone has a higher out-of-pocket cost than insurance-paid naloxone prescriptions,5 indicating the continued importance of prescribed naloxone and naloxone accessed in community-based settings. * * *
    • “Although naloxone dispensing has increased in recent years, opportunities remain to expand access given the continued high burden of opioid overdoses,1 such as by increasing co-prescribing of naloxone for patients with high-risk opioid prescriptions2,6 and reducing financial barriers.5“

From the U.S. healthcare business front,

  • The Wall Street Journal reports good news for Medicare Advantage insurers,
    • “The federal government plans to redo this year’s quality ratings of private Medicare plans, according to people familiar with the matter, a move that would deliver hundreds of millions in additional bonus payments to insurers next year.
    • “The decision by the Centers for Medicare and Medicaid Services could be announced as soon as Thursday. It comes in the wake of two court rulings that faulted the agency’s ratings, in cases filed by insurers SCAN Health Plan and Elevance Health.
    • “By paving the way for higher payments, the CMS move would provide a win for Medicare insurers at a time when their business is under pressure from rising healthcare costs and rates for next year that came in lower than investors had expected.'”
  • Mercer Consulting explores “Unlocking the power of [healthcare] price transparency data.”
  • MedTech Dive informs us,
    • “Philips has launched its Duo Venous Stent System in the U.S. to treat patients with blockages in their veins, the company said Wednesday.
    • “The implant, which won approval in December, is designed to address the root cause of chronic deep venous disease and comes in two forms for use in different types of veins. 
    • “Philips acquired the device in its 2022 takeover of Vesper Medical. The company paid 227 million euros upfront for Vesper to expand its image guided therapy business.”
  • and
    • “Medline has asked hospitals to remove thousands of endotracheal tubes because of a risk that components can tear or detach, blocking a patient’s airway. 
    • “The company recalled more than 168,000 Medline Sub-G Endotracheal Tubes and more than 13,000 kits, according to a Food and Drug Administration notice posted on May 28. The tubes are used for mechanical ventilation and have ports to prevent fluid from draining into patients’ lungs and causing pneumonia. 
    • “Medline recalled the products because the inflation tube and other components can detach or tear from the main tube, causing it to leak or deflate. If the device comes apart during use, it could also obstruct the patient’s airway or cause choking, the FDA said in a Tuesday notice.
  • and
    • “Abbott is recalling a system monitor used with the Heartmate cardiac pump because screen display issues could pose a risk to patients. The Class 1 recall affects 4,842 monitors distributed in the U.S. and worldwide, according to a June 7 database entry by the Food and Drug Administration.
    • “In an urgent medical device correction letter to physicians in May, Abbott said no serious adverse health consequences were reported and no devices are being removed from the market.
    • “The latest recall follows three others from earlier this year involving the Heartmate left ventricular assist system, the only such mechanical circulatory support device on the U.S. market after Medtronic stopped selling its Heartware pump in 2021.”

Midweek Update

David Ermer–ACA, Congress, Medical / Rx research, Medicare, NIH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Congress.gov tells us that the House Appropriations Committee’s markup of the Financial Services and General Government appropriations bill, which funds OPM and FEHB, has been postponed to June 13 at 11 am ET.
  • Modern Healthcare reports,
    • “National health expenditures rose 4.1% to $4.5 trillion in 2022, according to data the Centers for Medicare and Medicaid Services Office of the Actuary published in the journal Health Affairs Wednesday.
    • “Healthcare accounted for 17.3% of gross domestic product last year, down from 18.2% in 2021. The independent, nonpartisan CMS analysts previously projected healthcare spending would rise to $7.17 trillion, or 19.6% of gross domestic product, by 2031.
    • “Expenditures and their rate of change have stabilized since the worst phases of the COVID-19 pandemic in 2020 and 2021 caused spending to spike and healthcare as a share of GDP to increase, the actuaries’ report showed.”
  • Axios lets us know,
    • “Almost two years after the debut of a revamped national suicide hotline, its promise of a quicker, more seamless crisis response across the country is still a work in progress.
    • “Why it matters: Congress gave states $1 billion to build out the 988 hotline, amid nationwide concern over worsening mental health, with the expectation that states would establish their own own long-term funding to operate call centers and crisis services.”
    • “But those efforts have been uneven, contributing to significantly lower response times in certain states. As with much of the health care system, the level of crisis services available to people depends greatly on where they live.
    • “What they’re saying: “We want a system where everybody has a comparable experience. It seems to me we’re still a few years from that,” said Chuck Ingoglia, CEO of the National Council for Mental Wellbeing.
    • “He and other advocates and experts Axios spoke with said 988 implementation has been improving.”
  • Per the Department of Health and Human Services,
    • “Over the past decade, syphilis rates and case numbers in the U.S. have increased across all populations. In response to this surge in syphilis cases, HHS formed the National Syphilis and Congenital Syphilis Syndemic Federal Task Force led by HHS Assistant Secretary for Health Admiral Rachel Levine.
    • “Today, this task force issued new considerations for health care providers who test patients for syphilis. The new HHS document “Considerations for the Implementation of Point of Care Tests for Syphilis – PDF,” outlines four main differences between syphilis point of care tests and laboratory-based serologic syphilis tests and highlights the best settings to consider use of point-of-care tests. It also examines parameters for point of care testing program implementation and management, provides answers to common questions, and lists links to related resources.
    • “Syphilis testing is crucial, as syphilis infections can be difficult to diagnose because many of those infected may not have symptoms,” said Admiral Rachel L. Levine, MD, Assistant Secretary for Health. “The Food and Drug Administration has authorized two point-of-care tests for syphilis that can provide rapid test results during the same visit in about 15 minutes. This can help overcome barriers in our ability to timely diagnose patients in communities across the nation.”
  • Here’s a link to a new Health Affairs Forefront article on the Biden Administration’s ACA Section 1557 final rule.

From the public health and medical research front,

  • The New York Times reports,
    • “A new study linking the low-calorie sugar substitute xylitol to an increased risk of heart attack or stroke has once again raised questions about the risks and benefits of sugar substitutes.
    • “Xylitol is a sugar alcohol found naturally in fruits and vegetables, and even produced in the human body at very low levels. But it is often synthetically produced and is increasingly being added to processed foods, like candies and “low-sugar” baked goods, because it has 40 percent fewer calories than regular sugar does and doesn’t cause blood glucose to spike after a meal. The study authors said this rise in consumption was concerning, as the people most likely to turn to the sugar substitute may already be trying to manage conditions like obesity and diabetes that also increase the risk of cardiovascular issues.
    • “They may think they’re making a healthy choice by picking xylitol over sugar, yet the data argues that it is not the case.” said Dr. Stanley Hazen, the chair of cardiovascular and metabolic sciences at the Cleveland Clinic’s Lerner Research Institute and an author of the study. Last year, Dr. Hazen and his colleagues found a similar association with another sugar alcohol, called erythritol.”
  • Per the National Institutes of Health,
    • “Researchers have identified inherited genetic variants that may predict the loss of one copy of a woman’s two X chromosomes as she ages, a phenomenon known as mosaic loss of chromosome X, or mLOX. These genetic variants may play a role in promoting abnormal blood cells (that have only a single copy of chromosome X) to multiply, which may lead to several health conditions, including cancer. The study, co-led by researchers at the National Institutes of Health’s (NIH) National Cancer Institute, was published June 12, 2024, in Nature. * * *
    • “The scientists suggest that future research should focus on how mLOX interacts with other types of genetic variation and age-related changes to potentially alter disease risk.”
  • Following up on a FEHBlog post from last week, Beckers Hospital Review points out,
    • “The National Academies of Sciences, Engineering, and Medicine has proposed a more precise definition of long COVID-19.
    • “In its latest report, the group said long COVID needs to be understood as “an infection-associated chronic condition that occurs after COVID-19 infection and is present for at least three months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.” 
    • “This comes after the National Academies published research detailing more than 200 symptoms related to long COVID. 
    • “Our committee hopes this single definition, crafted with input from across research and patient communities, will help to educate the public about this widespread and highly consequential disease state,” Harvey Fineberg, MD, PhD, chair of the report’s authoring committee and president of the Gordon and Betty Moore Foundation, said in a June 11 news release.
    • “The new definition also says long COVID:
      • “Can involve any organ system and present with a range of symptoms.
      • “Can come after asymptomatic, mild, or severe SARS-CoV-2 infections.
      • “Can affect children and adults.
      • “Can be clinically diagnosed even without a biomarker.
      • “Can exacerbate preexisting conditions or present new ones.
      • “Can be delayed in onset for weeks or months following acute infection.
      • “Can resolve over a period of months or take years to resolve fully.”

From the U.S. healthcare business front,

  • MedCity News tells us,
    • “In 2021, Medicare Advantage beneficiaries spent about $2,541 less in out-of-pocket costs and premiums than beneficiaries with fee-for-service Medicare, a new report discovered.
    • “The report, released Monday, was conducted by healthcare research firm ATI Advisory and commissioned by Better Medicare Alliance, a research and lobby group for Medicare Advantage (MA). To conduct the study, the researchers used the 2019 to 2021 Medicare Current Beneficiary Survey and Cost Supplement files. The results of the study show an increase from last year’s report, which found that MA beneficiaries spent about $2,400 less than traditional Medicare on average in 2020.
    • “The researchers also found reduced spending among Medicare Advantage beneficiaries across racial and ethnic groups in 2021. Black MA beneficiaries paid $1,617 less in out-of-pocket costs and premiums than those in traditional Medicare, while Latino MA beneficiaries paid $1,593 less and White MA beneficiaries paid $2,371 less. In 2021, 25% of MA beneficiaries were Black or Latino, compared to 14% of traditional Medicare enrollees.”
  • Healthcare Dive lets us know,
    • “The Federal Trade Commission’s case aiming to block Novant Health from acquiring two Community Health Systems-owned North Carolina hospitals was dealt a series of blows this week. On Tuesday, U.S. District Court Judge Kenneth Bell ruled to deny the antitrust agency’s latest preliminary injunction against the deal. * * *
    • “Bell ruled last week the sale could go forward as planned, reasoning that the hospitals were likely to shutter entirely absent a sale, which could harm care access in the region. The judge further argued that the deal could have a net positive impact on competition in the region by allowing Novant to better compete with the area’s largest healthcare provider, Atrium Health.
    • “The FTC intends to fight that ruling in the 4th U.S. Circuit Court of Appeals. The antitrust agency filed its notice of appeal on Sunday, and petitioned a district court on Monday to pause the transaction during the appellate review.
    • “However, Bell denied the FTC’s latest request for a preliminary injunction, again citing the risk of hospital closures.”
  • Here’s a link to a law firm’s updated list of important takeaways for employees about the Pregnant Workers Fairness Act which took effect last June.

Thursday Miscellany

David Ermer–Congress, FDA, HSA, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Following up on the House Appropriations subcommittee’s approval of the Financial Services and General Government bill yesterday, Fedweek notes,
    • “By taking no position on a raise, the measure effectively endorses President Biden’s proposal for a 2 percent increase in January. That would follow the practice of most recent years of allowing the recommendation to take effect by default, and would result in the smallest raise since the 1 percent paid in January 2021. The measure however does continue longstanding language tying raises for wage grade employees to those of GS employees in an area, even though the two pay systems operate under separate locality-based rules.”
  • The Washington Post reports “Biden wants hospitals to report data on gunshot wounds.”
    • “The Biden administration is enlisting America’s doctors to help combat gun violence.
    • “About 160 health-care executives and officials have been invited to the White House today and Friday to promote public health solutions to the epidemic. A top priority, I’m told: The White House wants hospital emergency departments to collect more data about gunshot injuries their physicians treat, as well as routinely counsel patients about the safe use of firearms.”
  • Healthcare Dive informs us,
    • “A federal judge ruled Wednesday Novant Health can move forward with its plans to purchase two North Carolina hospitals from Community Health Systems, despite a request from the Federal Trade Commission to stall the deal.”A federal judge ruled Wednesday Novant Health can move forward with its plans to purchase two North Carolina hospitals from Community Health Systems, despite a request from the Federal Trade Commission to stall the deal.
    • “The antitrust agency sued to block the deal in January, claiming it would decrease competition and drive up consumer prices in the greater Lake Norman, North Carolina, area by allotting Novant more than 65% control of the region’s inpatient market.
    • “U.S. district judge Kenneth Bell denied the FTC’s request for an injunction, saying the hospitals are likely to shutter absent a deal.”
  • On a related note, the Wall Street Journal continues its series on hospital consolidation.

From the public health and medical research front,

  • The Washington Post reports
    • “A 59-year-old male resident of Mexico died after being infected with a bird flu subtype never before confirmed to have spread to humans, the World Health Organization said Wednesday.”
    • “The man, who suffered from other underlying health conditions, had no known exposure to poultry or other animals before being formally diagnosed by a laboratory with the H5N2 subtype of avian flu. The case marks the first time a human has been confirmed to be infected with this subtype, and the first time an avian H5 virus was confirmed in a person in Mexico.
    • “Due to the constantly evolving nature of influenza viruses, WHO continues to stress the importance of global surveillance,” WHO said in a statement. “This case does not change the current WHO recommendations on public health measures and surveillance of influenza,” it added, rating current risks to the general population as “low.”
  • and
    • “‘Unusual’ cancers emerged after the pandemic. Doctors ask if covid is to blame.”‘Unusual’ cancers emerged after the pandemic. Doctors ask if covid is to blame.
    • “It’s not a new idea that viruses can cause or accelerate cancer. But it will probably be years before answers emerge about covid and cancer.”
  • Mercer Consulting offers bird flu considerations for employers.
  • The NIH Director in her blog relates,
    • “The ability to communicate using only your thoughts might sound like the stuff of science fiction. But for people who don’t have the ability to speak or move due to injury or disease, there’s great hope that this may one day be possible using brain-computer interfaces (BCIs) that can “read” relevant brain signals and translate them into written or spoken words. A research team has made a preliminary advance in this direction by showing for the first time that a computerized brain implant can decode internal speech with minimal training.
    • “In the new NIH-supported study, researchers implanted such a device in a brain area known to be important for representing spoken words called the supramarginal gyrus in two people with tetraplegia, a condition marked by full body paralysis from the neck down due to cervical spinal cord injury. The researchers found that the device could decode several words the participants “spoke” only in their minds. While we are far from using such a device to decode whole sentences or even phrases, and the exact mechanisms of internal speech are still under study, the findings, reported in Nature Human Behavior , are notable because it had been unclear whether the brain signals involved in thinking words could be reproducibly translated. * * *
    • “While there is much more to learn about how to decode internal speech more reliably across individuals, the findings offer proof-of-concept for a high-performance internal speech BCI. The new research adds to a growing portfolio of rapidly advancing technologies supported by the BRAIN Initiative that could one day routinely restore the ability to communicate for those who can no longer speak or even move, including people with brain injuries, paralysis, or diseases such as amyotrophic lateral sclerosis (ALS).”
  • Per BioPharma Dive,
    • “Expert advisers to the Food and Drug Administration will need to weigh whether Eli Lilly’s experimental Alzheimer’s disease drug donanemab is widely effective or should be restricted only to people who have deposits in their brains of a toxic protein called tau, according to documents released Thursday ahead of a key regulatory meeting next week.
    • “The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well as on the risks of mild brain swelling that can result from donanemab and other drugs of its type.”The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well as on the risks of mild brain swelling that can result from donanemab and other drugs of its type.
    • “If approved, donanemab would be the third amyloid-targeted drug to launch. Biogen has withdrawn the first, called Aduhelm, after much controversy and few sales. Eisai, along with Biogen, more recently won approval of a second, called Leqembi, which brought in sales of $19 million in the first quarter.”

From the U.S. healthcare business front,

  • Health Affairs offers advice to employers about how to help employees reduce their healthcare costs.
    • “Employers, and especially small employers, may have limited ability to affect the direct causes of increasing spending—notably high prices. However, they do have some options that could lower the burden of out-of-pocket costs for their employees. Employers could partner with insurers to use more innovative cost-sharing structures in the health insurance benefits offered to their employees. In addition, they could increase the use of benefit designs that distribute costs more equitably, which may improve affordability for low- to middle-income workers.”
  • HR Dive tells us,
    • “In an era when retirement is frequently at the forefront of ageism, diversity and benefits conversations, older adults now make up a larger share of American workforce members over the age of 55. The Employee Benefit Research Institute found that adults aged 65 and older made up 29.5% of the workforce in 2023, compared to an estimated 23% in 2000.
    • “Additionally, EBRI noted that the share of Hispanic workers aged 55 and older more than doubled, with the share of older White workers dropping from about 87% to 81%.
    • “The changing demographic characteristics of the older workforce are “important considerations for employers to understand, as older workers and a more diverse work force calls for additional or new answers to the optimal design of employee benefit plans,” Craig Copeland, director of wealth benefits at EBRI, said in a release.”
  • EBRI also released a Fast Facts publication informing us that “HSAs Reduce Use of Outpatient Services and Prescription Drugs, Increase Use of Inpatient Services; Overall Spending Unaffected.”

Midweek Update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The House Appropriations Committee tells us, “Today, the House Appropriations Financial Services and General Government Subcommittee met to consider its Fiscal Year 2025 bill. The measure was approved by the Subcommittee.”
  • This bill provides appropriations for OPM and the FEHBP. The Committee summary of the bill describes its OPM appropriations as follows —
    • “Provides $477 million for the Office of Personnel Management (OPM), which is $31.4 million below the FY25 Budget Request and $29.1 million above the FY24 enacted level.”
  • Govexec informs us,
    • “Senate Democrats have vowed to move quickly on legislation protecting Americans’ access to in vitro fertilization and other forms of assistive reproductive technology, including a provision expanding federal workers’ access to those treatments as part of the government’s employer-sponsored health insurance program.
    • “On Monday, Sens. Tammy Duckworth, D-Ill., Patty Murray, D-Wash., and Cory Booker, D-N.J., introduced the Right to IVF Act, a repackaging of three separate previously introduced bills on reproductive health services.
    • “Included is the Family Building FEHB Fairness Act, first introduced last year by Duckworth, which would require the Federal Employees Health Benefits Program to cover additional costs associated with IVF, and would expand coverage to all types of assisted reproductive technology, such as gamete and zygote intrafallopian transfer.”
  • Govexec also pointed out this OPM Inspector General brief that summarizes OPM OIG recommendations that have been open for more than six months as of March 31, 2024. The FEHBlog understands why the FEHB open recommendations remain outstanding
  • Healthcare Dive lets us know,
    • “Congress appears to be inching toward injecting more transparency into a controversial program that forces drugmakers to give safety-net hospitals steep discounts on drugs.
    • “It would be a win for pharmaceutical manufacturers, which have long lobbied that hospitals be required to account for their savings in the 340B program — or that it be overhauled entirely.
    • “The latter appears unlikely, after lawmakers on both sides of the aisle expressed blanket support for 340B during a House Oversight and Investigations subcommittee hearing on Tuesday. However, members said they approved of more oversight to try and stop financial gaming in the program.
    • “Though “we’re all in support of 340B … I think nearly all of us agree that the status quo is not acceptable,” said Rep. Larry Bucshon, R-Ind.”
  • Yesterday, the U.S. Preventive Services Task Force released a final recommendation concerning “Falls Prevention in Community-Dwelling Older Adults: Interventions.” Its recommendations align with the recommendations currently in force.
  • Thompson Reuters Practical Law relates,
    • “In litigation under the No Surprises Act (NSA), a district court concluded that there is no cause of action for health providers to enforce awards involving surprise billing disputes under the NSA’s independent dispute resolution (IDR) process (Guardian Flight LLC & Med-Trans Corp. v. Health Care Serv. Corp., (N.D. Tex. May 30, 2024)).”
  • The American Hospital Association News shares the organization’s “comments [submitted’ June 5 on the Centers for Medicare & Medicaid Services’ inpatient prospective payment system proposed rule for fiscal year 2025, expressing support for several provisions, including certain policies supporting low-volume and Medicare-dependent hospitals, and several aspects of CMS’ quality-related proposals. However, AHA raised concerns about the rule’s proposed payment updates.”

From the public health and medical research front,

  • CNN reports,
    • “About 61% of US adults will have cardiovascular disease by 2050, new research from the American Heart Association predicts. The biggest driver of this trend will be the large number of people who have or will develop high blood pressure, which makes them much more likely to develop dangerous problems like a heart attack or stroke.
    • “Other cardiovascular problems include heart attacks, arrhythmias like atrial fibrillation or a-fib, heart failure and congenital heart disease. * * *
    • In the research published Tuesday, the association predicts that 45 million adults will have some form of cardiovascular disease – excluding high blood pressure – or will have a stroke in 2050, up from 28 million in 2020.
  • The New York Times reports,
    • One of the nation’s premier medical advisory organizations has weighed in on long Covid with a 265-page report that recognizes the seriousness and persistence of the condition for millions of Americans.
    • More than four years since the start of the coronavirus pandemic, long Covid continues to damage many people’s ability to function, according to the National Academies of Sciences, Engineering and Medicine, a nongovernmental institution that advises federal agencies on science and medicine.
  • and
    • “A committee of advisers to the Food and Drug Administration voted on Wednesday to update the formula for the Covid vaccine ahead of an anticipated fall immunization campaign, now an annual step to try to offer better protection against versions of the virus in circulation.
    • “The unanimous vote by the 16 advisers recommends a formula aimed at combating the variant JN.1, which dominated infections in the United States in February, or a version of it. In recent weeks, JN.1 has been overtaken by descendants known as KP.2 and KP.3.
    • “In the coming weeks, the F.D.A. is expected to formally recommend a variant target for vaccine makers for the next round of shots in the late summer or early fall. Any decision involves some educated guesswork, given that any new vaccine formula won’t be available until months after a variant becomes dominant.
    • “It’s becoming clear that the ideal timing for a vaccine composition decision remains elusive,” said Jerry Weir, an official with the F.D.A.’s vaccine division.”
  • Per Biopharma Dive,
    • “A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.”A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.
    • “Data presented at the American Society of Clinical Oncology annual meeting suggest the test can support prostate cancer diagnosis in people who are missed by other screening methods.
    • “The researchers are now comparing the saliva test to several screening methods such as fast MRI scans and prostate-specific antigen (PSA) blood tests to determine the best approach.”
  • and
    • “Eli Lilly’s drug tirzepatide — sold as Zepbound for obesity — continues to show promise in the liver disease MASH. Clinical trial data disclosed in an abstract ahead of a European medical conference indicates that, after one year, the shot helped improve liver fibrosis without worsening MASH in just over half of treated participants, compared with 30% of those given placebo. Lilly had hinted at the study’s success earlier this year, but the full data will provide a more complete view of tirzepatide’s potential. The abstract’s release comes one day after Viking Therapeutics released trial data for its MASH pill VK2809 and less than two months after Madrigal Pharmaceuticals won U.S. approval of the first MASH drug.”
  • The Institute for Clinical and Economic Research “today posted a Protocol outlining how it will conduct the fourth annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. These standards were developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies.”
  • Per MedPage Today,
    • “The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).”The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).
    • “Healthcare providers should discuss and offer doxy PEP to people in these populations with a history of at least one bacterial STI — specifically syphilis, chlamydia, gonorrhea — in the last 12 months, Lindley Barbee, MD, of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, and colleagues wrote in Morbidity and Mortality Weekly Report.”
    • “Doxy PEP represents the first new STI prevention tool in decades, at a time when innovation in the nation’s fight against STIs is desperately needed,” said Barbee in a CDC statement.
  • The National Institutes of Health announced,
    • “The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”
  • The Washington Post reports, “Male birth control gel shows promise in early-stage clinical trials. “A National Institutes of Health official said the findings marked a milestone, even if the product is probably years away.”

From the U.S. healthcare business front,

  • KFF informs us,
    • The Medical Loss Ratio (MLR) provision of the Affordable Care Act (ACA) limits the amount of premium income that insurers can keep for administration, marketing, and profits. Insurers that fail to meet the applicable MLR threshold are required to pay back excess profits or margins in the form of rebates to individuals and employers that purchased coverage.
    • In the individual and small group markets, insurers must spend at least 80% of their premium income on health care claims and quality improvement efforts, leaving the remaining 20% for administration, marketing expenses, and profit. The MLR threshold is higher for large group insurers, which must spend at least 85% of their premium income on health care claims and quality improvement efforts. MLR rebates are based on a 3-year average, meaning that rebates issued in 2024 will be calculated using insurers’ financial data in 2021, 2022 and 2023 and will go to people and businesses who bought health coverage in 2023.
    • This analysis, using preliminary data reported by insurers to state regulators and compiled by Mark Farrah Associates, finds that insurers estimate they will issue a total of about $1.1 billion in MLR rebates across all commercial markets in 2024. Since the ACA began requiring insurers to issue these rebates in 2012, a total of $11.8 billion in rebates have already been issued to individuals and employers, and this analysis suggests the 2012-2024 total will rise to about $13 billion when rebates are issued later this year.
  • TechTarget calls our attention to the fact that “As providers seek to advance patient-centered care, many behavioral health organizations are turning to their EHR vendors to support integrated care models, according to a KLAS report.” Yippee.
  • Beckers Hospital Review lets us know,
    • “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. 
    • “The sales will be conducted in two rounds. The first round, which includes the health system’s physician group, Stewardship Health, and all Steward hospitals excluding its Florida facilities and some of the Texas hospitals, will have a bid deadline of June 24 and a first sale hearing July 11.
    • “The second round includes Steward’s Florida hospitals and four of its Texas facilities, with a bid deadline of Aug. 12 and a sale hearing of Aug. 22.”
  • Beckers Payer Issues tells us about the payers that landed on the 2024 Fortune 500.