Midweek Update

COVID-19 vaccine

Midweek Update

David Ermer–CMS, COVID-19 vaccine, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Per an HHS press release,
    • “As part of the continued implementation of the Biden-Harris Administration’s historic prescription drug law, the Inflation Reduction Act, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), released final guidance – PDF
       today outlining the process for the second cycle of negotiations under the Medicare Drug Price Negotiation Program. The guidance also explains how CMS will help ensure people with Medicare can access drugs at the negotiated prices from the first and second cycles when those prices become effective beginning in 2026 and 2027, respectively.” * * *
    • “For the fact sheet on the Medicare Drug Price Negotiation Program Final Guidance for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027, visit https://www.cms.gov/files/document/fact-sheet-medicare-drug-price-negotiation-program-ipay-2027-final-guidance-and-mfp-effectuation.pdf – PDF“
      .
  • Modern Healthcare lets us know,
    • “Getting top quality scores will continue to be a challenge for Medicare Advantage insurers that had grown accustomed to high star ratings and lucrative bonus payments.
    • “That’s because the Centers for Medicare and Medicaid Services is elevating most of the “cut points” used to calculate 2025 Medicare Advantage star ratings, according to financial analysts and consultants who previewed the agency’s guidelines before the highly anticipated release of the latest ratings later this month. Cut points are the upper and lower thresholds for each measure that collectively generates a plan’s overall score on a one-to-five scale.
    • “Higher cut points will make it more difficult for plans to score better or even retain current ratings for individual metrics, said Alexis Levy, senior partner at HealthScape Advisors, which is part of the consultancy Chartis Group.
    • “If you’re a health plan and your performance stay the same, but the cut points move, you could lose a star rating on a given measure because you didn’t keep up with the overall market,” Levy said.”
  • The Wall Street Journal adds,
    • “Humana shares slid more than 10% Wednesday after the health insurer warned that a steep drop in the federal government’s quality ratings of its Medicare plans could hit its results in 2026.
    • “Humana said it has about 25% of its members currently enrolled in plans rated four stars and above for 2025 based on preliminary 2025 Medicare Advantage ratings data from the Centers for Medicare and Medicaid Services, down from 94% this year. 
    • ‘The quality ratings, on a scale of one to five stars, are tied to bonuses paid to insurers. The downgrade could have a huge revenue impact in 2026, with analysts suggesting a range of figures, from less than $2 billion to far higher.
    • “The scale of the drop is a shock,” said Sarah James, an analyst with Cantor Fitzgerald, who projected the shift in stars could affect nearly $3 billion in 2026 revenue if Humana isn’t able to alleviate it.”
  • FedWeek offers a generic comparison of 2025 FEHB and PSHB plans.
  • Fedsmith delves into the recent FEHB / PSHB premium increase.

From the public health and medical research front,

  • STAT News reports,
    • “U.S. health officials have run into obstacles in their efforts to determine whether a Missouri person infected with H5N1 bird flu passed the virus on to others, causing a delay that will likely fuel concerns about the possibility that there has been human-to-human transmission.
    • “The Centers for Disease Control and Prevention has blood samples from several health workers and a household contact of the Missouri case that it plans to test for antibodies that would indicate whether they too had been infected with the virus, an agency official told STAT.
    • “But the CDC has had to develop a new test to look for those antibodies because key genetic changes to the main protein on the exterior of the virus found in the Missouri case meant the agency’s existing tests might not have been reliable, Demetre Daskalakis, director of the CDC’s National Center on Immunization and Respiratory Diseases, said in an interview. He suggested it will be mid-October before the work can be completed.
    • “The antibodies that would grow in the person exposed to that virus would then be different then the antibodies that would grow in a person who had a virus without those mutations,” Daskalakis said.
    • “Developing the new test has been challenging because the sample from the patient contained so little viral material that the CDC was not able to grow whole viruses from it. Instead, its scientists have had to reverse engineer H5N1 viruses that contain the changes to use them as the basis for the new serology test, he said.”
  • Healio informs us,
    • “Adults who more frequently consumed several flavonoid-rich foods, like berries and tea, had a significantly lower risk for dementia, according to an analysis published in JAMA Network Open.
    • “Certain individuals, like those with depressive symptoms or hypertension, benefited even more from higher adherence to a flavonoid-rich diet, the researchers found.
    • “Flavonoids and flavonoid-rich foods have been previously tied to reduced risk for several diseases and health outcomes, including type 2 diabetes and mortality in those with colorectal cancer.”
  • Health Day adds,
    • “Folks who received the three doses of a COVID vaccine got heart protection, too
    • “The protection translated to reduced risk of serious heart problems stemming from a COVID infection
    • “However, the short-term risk of a serious heart complication owing to the vaccine was real but rare.”
  • Per an NIH press release,
    • “A scientific team supported by the National Institutes of Health (NIH) unveiled the first complete map of the neural connections of the common fruit fly brain. The map provides a wiring diagram, known as a connectome, and is the largest and most complete connectome of an adult animal ever created. This work offers critical information about how brains are wired and the signals that underlie healthy brain functions. The study, which details over 50 million connections between more than 130,000 neurons, appears as part of a package of nine papers in the journal Nature.  
    • “The diminutive fruit fly is surprisingly sophisticated and has long served as a powerful model for understanding the biological underpinnings of behavior,” said John Ngai, Ph.D., director of NIH’s Brain Research Through Advancing Innovative Neurotechnologies Initiative®, or The BRAIN Initiative®. “This milestone not only provides researchers a new set of tools for understanding how the circuits in the brain drive behavior, but importantly serves as a forerunner to ongoing BRAIN-funded efforts to map the connections of larger mammalian and human brains.”
  • The American Hospital Association News notes,
    • “As health care environments shift, hospitals and health systems can experience challenges in adjusting their infection and prevention control practices to accommodate the changes. AHA examined these challenges in partnership with member hospitals and Upstream Thinking and determined that using human-centered design can help identify ways to improve upon current practice. READ MORE “

From the U.S. healthcare business front,

  • KFF finds,
    • “One or two health systems controlled the entire market for inpatient hospital care in nearly half (47%) of metropolitan areas in 2022.
    • “In more than four of five metropolitan areas (82%), one or two health systems controlled more than 75 percent of the market.
    • ‘Nearly all (97% of) metropolitan areas had highly concentrated markets for inpatient hospital care when applying HHI thresholds from antitrust guidelines to MSAs.”
  • Modern Healthcare reports,
    • “Independent lab companies have continued their transaction spree in 2024, either by forming partnerships with hospitals and health systems or by outright acquiring some of their lab assets.
    • “Quest Diagnostics has announced seven acquisitions this year, including its recent purchase of select lab assets from Minneapolis-based Allina Health. Slated to close later this year are deals with OhioHealth in Columbus and University Hospitals in Cleveland.
    • ‘Meanwhile, Labcorp has closed three acquisitions this year, with Springfield, Massachusetts-based Baystate Health, Renton, Washington-based Providence Health and Services and Naples, Florida-based NCH Healthcare System. It recently announced plans to acquire the lab assets of Johnson City, Tennessee-based Ballad Health in a deal expected to close in December.”
  • The American Hospital Association News points out,
    • “The Department of Health and Human Services Sept. 30 released a statement on the dockworker strike at ports along the East and Gulf coasts, saying that immediate impacts to medicines, medical devices and other goods should be limited. HHS, the Food and Drug Administration and the Administration for Strategic Preparedness and Response are working with trade associations, distributors and manufacturers to limit impacts on consumers and assess vulnerabilities. The AHA is monitoring the situation.  
    • “According to Healthcare Ready, a nonprofit organization that works with the government, providers, and supply chain organizations to enhance the resiliency of communities before, during and after disasters, a substantial number of pharmaceuticals commonly used in the care of patients come through the ports every day. Given the shortages that already exist for many medications, and the disruption in the supply of IV solutions caused by the flooding of the Baxter plant in North Carolina, AHA will be alert for potential shortages of vital pharmaceuticals related to the strike.”
  • Per Healthcare Dive,
    • A major California health plan has struck a novel deal directly with a drug manufacturer for a cheaper version of Humira, cutting out pharmacy benefit managers — controversial middlemen in the drug supply chain that typically control access to medication — entirely.
    • As a result of the deal, Blue Shield of California will purchase a Humira biosimilar for $525 per monthly dose, significantly below the drug’s net price of $2,100.
    • The biosimilar will be available for most of BSCA’s commercial members at $0 co-pay starting Jan. 1, 2025, according to the insurer, which announced the deal Tuesday.

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • Govexec tells us,
    • “President Biden formalized his plan to provide civilian federal workers with an average pay increase of 2% next year, in a letter to congressional leaders Friday.
    • “Last March, Biden first announced the pay raise plan as part of his fiscal 2025 budget proposal, marking a significant decrease from previous pay raises of 5.2% in 2024 and 4.7% in 2023. Friday’s announcement confirms that, if implemented, federal employees will see an across-the-board boost of 1.7% to basic pay and an average 0.3% increase to locality pay, a slight departure from the traditional 0.5% of the overall raise figure being set aside for locality adjustments.”
  • and
    • “In accordance with a 2021 Biden administration executive order promoting voting access, OPM in 2022 began requiring agencies to provide federal employees up to four hours of administrative leave to vote in federal, state, local, tribal and territorial elections, which can be used both on Election Day and during early voting. Additionally, agencies must provide an additional four hours of paid leave to employees who serve as election judges or observers.
    • “In a memo to agency heads Thursday, acting OPM Director Rob Shriver reminded agencies of the new voting leave rules.”
  • The Washington Post reports,
    • “Tens of thousands of D.C. residents on Friday will begin receiving letters with good news. That medical debt weighing them down? Poof, it’s gone.
    • “D.C. has deals in place to cancel $42 million in medical debt for 62,000 residents, through a partnership with a nonprofit that has helped cities and states across the country purchase the debt for pennies on the dollar, city officials said.
    • “The program is one way, they say, to ease a financial burden that can have ramifications for jobs, housing and physical and mental health, and disproportionately impacts people of color.
    • “In the District, about 60 percent of the total debt relief will benefit 36,000 residents making $25,000 or less, and 80 percent of residents receiving the relief live in D.C. Zip codes that are majority Black or Latino, city officials said.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention lets us know,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.”
    • “COVID-19
      • “COVID-19 activity is elevated nationally, with continued increases in many areas and early signs of decline in others. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • The University of Minnesota’s CIDRAP adds,
    • “Wastewater SARS-CoV-2 detections are still at the very high level and are highest in the South. Though levels are dropping in the West, they are rising in the South, Midwest, and Northeast, the CDC said.
    • “Meanwhile, wastewater tracking from WastewaterSCAN shows that detections nationally are still at the high level, with no clear trend up or down over the past 3 weeks. The group, however, noted an upward trend in the Midwest.”
  • and
    • “The US Food and Drug Administration (FDA) today announced that it has granted emergency use authorization for Novavax’s updated COVID-19 vaccine. 
    • “Approval of the protein-based vaccine comes about a week after the FDA green-lighted the two updated mRNA vaccines—made by Moderna and Pfizer-BioNTech—which target the KP.2 variant. The Novavax vaccine targets JN.1, the parent of KP.2.
    • “Novavax’s updated vaccine is authorized for people ages 12 and older.” 
  • The New York Times reports,
    • “Wegovy, the popular obesity drug, may have yet another surprising benefit. In a large clinical trial, people taking the drug during the pandemic were less likely to die of Covid-19, researchers reported on Friday.
    • “People on Wegovy still got Covid, and at the same rate as people randomly assigned to take a placebo. But their chances of dying from the infection plunged by 33 percent, the study found. And the protective effect occurred immediately — before participants had lost significant amounts of weight.
    • “In addition, the death rate from all causes was lower among subjects taking Wegovy, a very rare finding in clinical trials of new treatments. The result suggests that lower life expectancy among people with obesity is actually caused by the disease itself, and that it can be improved by treating obesity.
    • “Stunning,” Dr. Jeremy Faust, an emergency room physician at Brigham and Women’s Hospital who wrote an editorial accompanying the study, said of the data. The study was published in The Journal of the American College of Cardiology.”
  • What’s more, STAT News informs us,
    • “Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment.
    • “Researchers combined data on nearly 4,000 patients across four trials who had heart failure with reduced ejection fraction (or HFpEF) and found that 5.4% of those treated with Wegovy experienced cardiovascular-related death or heart failure events, compared with 7.5% of those who received placebo. This translated to a 31% risk reduction.
    • “On heart failure events, defined as hospitalizations or urgent care visits, Wegovy cut the risk by 41%. On cardiovascular-related deaths, it reduced the rate by 18%, but this result was not statistically significant, according to the data, presented Friday at the annual meeting of the European Society of Cardiology and published in the Lancet.”
  • and
    • “An experimental drug from Alnylam Pharmaceuticals substantially cut the risk of death and serious cardiovascular complications among patients with an increasingly diagnosed heart disease, likely teeing up the medicine to be a new option for patients, but one that will face competition from another treatment [from Bridge Bio] also nearing potential approval. 
    • “The full results from the Phase 3 HELIOS-B study, presented here Friday at the European Society of Cardiology’s annual meeting, bolstered the case that the drug, vutrisiran, can offer added benefits for patients with the progressive disease, known as ATTR-CM. Top-line data were released in June.
  • Per FiercePharma,
    • “As a new deadly strain of mpox continues its global spread, Emergent BioSoultion’s smallpox vaccine ACAM2000 has officially joined the ranks of FDA-approved defense measures against the virus.
    • ‘The FDA signed off on the vaccine’s use as an mpox disease preventive in those deemed to be at a high risk for infection.” * * *
    • “Emergent last week linked up with the U.S. government and the World Health Organization (WHO) to donate 50,000 doses of ACAM2000 to the impacted countries the Democratic Republic of Congo, Burundi, Kenya, Rwanda and Uganda through relief organization Direct Relief.” 
  • Here’s food for weekend thought. NBC News reports,
    • “For adults who struggle to get the recommended amount of quality sleep, new research suggests “catching up” those lost hours on the weekends may significantly decrease the risk of heart disease. 
    • “Many people build up “sleep debt” during the week, hoping to make up for it by getting extra hours over the weekend. Sleep debt is the difference between how much quality sleep we need — at least seven hours each night — and how much we actually get, according to the Cleveland Clinic.
    • “In a new analysis being presented Sunday at the European Society of Cardiology Congress in London, cardiovascular researchers based in China found that people who got the most sleep on the weekend were 19% less likely to develop heart disease, compared with a group who slept the fewest extra hours those two days.  
    • “Previous research has shown that not getting enough sleep is associated with poor health. However, there has been little research into how getting extra sleep on the weekend affects the heart.

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “U.S. hospitals reported strong operating margins on growing patient volumes in July, according to new data from analytic solutions firm Strata.
    • “Hospitals’ median year-to-date operating margin climbed from 4.9% in June to 6.5% in July amid increasing demand for both inpatient and outpatient services, according to the report.
    • “Still, expense increases were “sizable” in July, Strata said. Non-labor expenses, including for drugs and supplies, grew at a quicker clip than labor costs year over year.”
  • and
    • “Steward Health Care has signed definitive agreements to sell four Massachusetts hospitals and is close to finalizing agreements to transition two other facilities to new operators, according to documents filed in U.S. federal bankruptcy court Thursday.
    • “Rhode Island-based Lifespan Health System will pay $175 million for the operating licenses, buildings and land associated with St. Anne’s Hospital in Fall River and Morton Hospital in Taunton, according to the purchase agreement. Massachusetts-based Lawrence General Hospital plans to take over both Holy Family Hospital campuses in Methuen and Haverhill for approximately $28 million.
    • “Steward is “continuing to work to finalize” deals to sell St. Elizabeth’s Medical Center and Good Samaritan Medical Center to Boston Medical Center, according to a press release Thursday.”
  • Beckers Hospital Review identifies five major health system mergers yet to close.
  • Per Fierce Healthcare,
    • “Pennsylvania-based insurer and care delivery network Highmark Health recorded $7.4 billion in revenue and $223 million in net income during the second quarter.
    • “Combined with first-quarter results, Highmark’s revenue is 8% higher year over year compared to the first half of 2023.
    • “Executives credited Highmark Health Plans, United Concordia Dental and HM Insurance Group for the robust results.
    • “Highmark Health continues to be financially strong and stable, positioning our organization to adapt and succeed as the healthcare landscape continues to evolve,” said Carl Daley, chief financial officer and treasurer of Highmark Health, in a news release.
    • “After entering southeastern Pennsylvania, with plans to launch Medicare Advantage products in 2025, the health plan’s segment said membership was stronger than anticipated. 
    • “Still, high pharmaceutical costs, utilization trends and Medicaid redeterminations are headwinds to the business.”

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, FDA, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Govexec reports,
    • “Republican leaders on the House Homeland Security Committee want to know what the Biden administration is doing about Havana syndrome, mysterious brain injuries that became public in 2016 after State Department officials in Cuba’s capital city were affected. 
    • “We are deeply alarmed that these incidents continue to take place here and abroad, and that there has been little to no explanation from the administration as to who or what has caused these phenomena,” wrote full committee Chairman Mark E. Green, R-Tenn., and Counterterrorism, Law Enforcement and Intelligence Subcommittee Chairman August Pfluger, R-Texas, in a letter to National Security Advisor Jake Sullivan Tuesday. 
    • “The brain injuries, referred to as anomalous health incidents, include symptoms of headaches, pain, nausea, disequilibrium and hearing loss. Additional reports of similar symptoms later emerged from federal employees in other countries such as China, Russia, Vietnam, Colombia and various parts of Europe.
    • “Green and Pfluger, who have held numerous hearings and briefings on this matter, requested a committee briefing from the National Security Council. They also urged the administration to prioritize expending unused funds allocated to provide care for AHI victims and to fully implement the HAVANA Act, a 2021 law that authorizes payments to impacted intelligence, diplomatic and other governmental personnel.”  
  • Reuters informs us,
    • “The U.S. Navy has received more than 546,500 claims for compensation from people impacted by decades of contaminated water at Marine Corps Base Camp Lejeune in North Carolina, a new court filing shows, putting it squarely among the largest injury cases of all time.
    • “That number may fluctuate up or down by a few thousand, the government said in the filing, opens new tab. The U.S. Navy is reviewing additional claims received up to the Aug. 10 deadline and removing claims that are found to be duplicates.
    • “The number of administrative claims filed with the U.S. Navy – a step claimants must have taken by the Aug. 10 deadline to receive compensation for injuries they attribute to the water – surpasses the nearly 400,000 lawsuits filed over 3M Co’s military-issue earplugs, which is regarded as the largest multidistrict litigation in history.”
  • The Chair and Ranking Member of the House Education and Labor Committee sent a letter to the Assistant Secretary of Labor who handles ERISA matters. The letter asks the Assistant Secretary about the Department’s efforts to “address troubling practices of certain group health plan service providers.”
  • Federal News Network interviews Colleen Heller-Stein, the first career fed to lead the CHCO Council.

From the public health and medical research front,

  • Per a Food and Drug Administration press release,
    • “Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.”
  • Beckers Hospital Review offers three notes on the FDA action.
  • The Wall Street Journal adds,
    • “The two shots [Pfizer and Moderna] will be available to anyone over 6 months of age, a move that comes as Covid hospitalizations continue to climb and remain higher than they were at this time last year, according to data from the Centers for Disease Control and Prevention. 
    • “Doctors say everyone who is eligible should get a shot. But older people who have skipped other recent vaccine updates should especially consider it. 
    • “I saw a lot of people in the hospital who got a lot of shots in the beginning of the pandemic and then didn’t get any shots for a year or two years,” said Dr. Peter Chin-Hong, a professor of medicine at University of California-San Francisco and an infectious-disease specialist. * * *
    • “Unless you’re very concerned about acquiring Covid right now, my recommendation would be to get it in September or October,” said Dr. William Schaffner, a professor of preventive medicine at the Vanderbilt University School of Medicine. “That will provide the best protection throughout the winter season.” 
    • “The CDC recommends people get one of the new vaccines by the end of October. Both will be available at local clinics and pharmacies.” 
  • The American Hospital Association News lets us know,
    • “The Food and Drug Administration Aug. 22 granted emergency use authorization for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-19 Dual Test is authorized for use by laboratories to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens. The Flowflex Plus COVID-19 and Flu A/B Home Test is authorized for home use for people aged two and older.” 
  • The American Medical Association lets us know what doctors wish their patients knew about pre-eclampsia.
  • MedPage Today suggests that “Europe Offers Clues for Solving America’s Maternal Mortality Crisis.”
  • The Brown and Brown consulting group makes an urgent call for employers worldwide to become more aware of the risk of suicide among their employees and engage in suicide prevention efforts.
  • Beckers Hospital Review shares patient safety goals at top rated U.S. hospitals.
  • Per HealthDay, “The overdose-reversing drug naloxone can help save the lives of people whose hearts have stopped due to an opioid OD, a new study shows.”
  • The Institute for Clinical and Economic Review’s “independent appraisal committee voted that current evidence is not adequate to demonstrate net health benefits for imetelstat added to best supportive care when compared to best supportive care alone; treatment [for the treatment of anemia in patients with low-to-intermediate risk myelodysplastic syndrome] would meet common thresholds of cost effectiveness if priced between $94,800 to $113,000 per year, therapy currently priced at approximately $365,000 per year.”

From the U.S. healthcare business front,

  • Modern Healthcare tells us,
    • A federal judge’s ruling this week that blocked the Federal Trade Commission’s near-total ban on noncompete clauses in employment contracts is creating more uncertainty for healthcare employers as they await the agency’s next move.
    • Federal regulators have cracked down on what they view as anticompetitive behavior in recent years, particularly in healthcare. The FTC’s nationwide noncompete ban will no longer take effect Sept. 4, but that doesn’t mean the issue is resolved.
    • Noncompete agreements are common in the healthcare industry. Many organizations, including hospitals, health systems, physician groups, insurance companies and pharmacy benefit managers, use the agreements in employment contracts to protect business interests and ensure competitors don’t obtain proprietary information.” * * *
    • “The FTC has said Tuesday’s ruling does not remove its authority to challenge noncompete bans on a case-by-case basis.”
    • “There’s not going to be any certainty on this for a while,” said Jason Weber, an employment attorney at law firm Polsinelli.” * * *
    • “Polsinelli’s Weber said companies should try to reduce confusion by educating employees on the ruling and emphasizing that noncompete obligations remain in effect.
    • Weber said employers also have a good opportunity to assess their existing agreements and reevaluate whether noncompete clauses are essential to protecting their businesses. For example, employers could use less-restrictive options such as non-solicitation covenants, he said.” 
  • Beckers Payer Issues lists,
    • “Several insurers [that] landed on Forbes’ annual ranking of the “Best Employers by State.” 
    • “The 2024 ranking, published Aug. 20, sorts 1,294 top employers in the U.S. by state. Forbes surveyed more than 160,000 employees at companies with more than 500 people. Respondents evaluated their current employers, employers they’d worked with in the past two years and organizations they knew through their industry. 
    • “Insurers appeared among the top employers in most states, except for Alaska, Delaware, Washington, D.C., Idaho, Maine, Mississippi, Montana, Oklahoma, Rhode Island, Vermont and Wyoming.” 
  • Medscape relates,
    • “Most physicians oppose the way standardized relative value units (RVUs) are used to determine performance and compensation, according to Medscape’s 2024 Physicians and RVUs Report. About 6 in 10 survey respondents were unhappy with how RVUs affected them financially, while 7 in “10 said RVUs were poor measures of productivity.
    • The report analyzed 2024 survey data from 1005 practicing physicians who earn RVUs.” * * *
    • “[O]ver half of clinicians said alternatives to the RVU system would be more effective, and 77% suggested including qualitative data.” 
  • Per Fierce Healthcare,
    • “A Thursday afternoon [bankruptcy] sale hearing scheduled for several Steward Health Care hospitals was shelved in favor of an amended bankruptcy court itinerary hashing out multiple disputes related to the company’s pending deals for hospitals in Florida and Pennsylvania.”  ***
    • “Though not the focus on Thursday’s hearing, Steward’s counsel also opened the hearing with quick updates on developments in Massachusetts and Ohio.
    • “For the former, Candace Arthur, who represents Steward, said that the company’s estate is “very close to the finish line and still fully engaged in mediation” regarding the deal announced last week.
    • “As for Ohio, where closure notices were issued yesterday for two Steward hospitals, Arthur described those filings as “a deadline thing.”

Tuesday Tidbits

David Ermer–Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Per a Senate press release,
    • “U.S. Senator Sherrod Brown (D-OH) announced [on August 12, 2024] the introduction of legislation to make it easier for workers without 4-year college degrees, including veterans, to get federal jobs, and to promote hiring based on workers’ skills rather than the degree they attain.
    • “The Federal Jobs for STARs Act would make federal jobs more accessible for non-degree-holders by taking steps to reduce or remove unnecessary educational requirements and making it easier for Ohioans to search on USAJOBS.com for jobs that match their experience and skills.
  • Federal News Network lets us know,
    • “New instances of fraud in the government’s Flexible Spending Account program, FSAFEDS, are dwindling. But the investigation into the issue remains ongoing. In total, fraudulent activity in the Office of Personnel Management benefits program has now cost more than $1 million. OPM has been working with FSAFEDS vendor HealthEquity to secure impacted federal employee accounts and add security measures to the program. OPM’s inspector general office is also working with the FBI to look into the issue further. But OPM said there’s so far no evidence of the FSAFEDS systems being compromised.”
  • Per a CMS press release,
    • “CMS is encouraging pharmacies and other affected parties to prepare now for the expected transition of coverage from Medicare Part D to Medicare Part B for Preexposure Prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. We expect to release the final National Coverage Determination (NCD) in late September 2024. Coverage under Part B will begin once we release the final NCD.
    • “Do you have questions about pharmacy enrollment?  We’re going to answer your questions so you can prepare your pharmacy for Part B coverage of PrEP for HIV during Pharmacy Enrollment Office Hours on Thursday August 22 from 3:30-4:30 pm ET. 
    • “Register for this webinar. After you register, you’ll receive a confirmation email with information about joining the webinar.”
  • The American Hospital Association News informs us,
    • “The AHA Aug. 13 commented to the Medicare Payment Advisory Commission in anticipation of the commission’s 2024-2025 cycle. The AHA urged MedPAC to carefully consider the negative consequences for beneficiaries, providers and communities if Medicare payments to 340B hospitals are cut; reconsider its pursuit of inpatient rehabilitation facility-skilled nursing facility site-neutral payment policy; support updates to physician reimbursement that more adequately account for inflation; and recommend repealing in-person visit requirements for tele-behavioral health services.

From the public health and medical research front,

  • MedCity News tells us,
    • “There are more than 123 million people in the U.S. living with obesity, and this prevalence is largely due to a lack of access to care, environmental factors, stigma and inadequate coverage, according to a new report. Tackling these issues will take a “multifaceted approach,” the report states.
    • “The publication was released last week in the American Journal of Managed Care and was funded by the Diabetes Leadership Council, a nonprofit patient advocacy organization. The researchers conducted an internet search of relevant studies and government reports.
    • “Our goal is to ensure that people are getting the right treatment at the right time for them. And we understand that this looks differently for everybody … and not everyone fits the same mold,” said Erin Callahan, chief operating officer of Diabetes Leadership Council and Diabetes Patient Advocacy Coalition, in an interview. “So our goal is to ensure that people are well cared for and have equitable access to the things they need along any part of their medical journey.”
  • Cardiovascular Business notes,
    • “Over the past few decades, research has clearly shown that there are distinct characteristics of ischemic heart disease in women that are not seen in men. While women often need tailored diagnostic approaches for diagnosis and treatment, the one-size-fits-all approach using the male heart disease presentations as the standard of care has likely impacted female mortality in terms of cardiac deaths, which is the No. 1 killer in the world for both men and women.
    • “Emily Lau, MD, director of the Cardiometabolic Health and Hormones Clinic at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, shed light on the critical issue of gender differences in chest pain imaging evaluations in sessions at the American College of Cardiology (ACC) 2024 meeting earlier this year. She spoke with Cardiovascular Business about her presentation.
    • “Women are more likely to present with non-obstructive coronary disease,” Lau explained. “This means they may not have significant blockages in their arteries, but they still experience symptoms of heart disease.”
  • Beckers Hospital Review points out,
    • “Adverse drug reactions [affecting the skin] are a known risk of antibiotic use, but it has been unclear which drug classes carry the highest risk — until now. 
    • “To crack at this mystery, researchers in Toronto analyzed two decades worth of data on hospitalizations and emergency department visits for serious skin reactions in older adults, according to a study published Aug. 8 in JAMA. They compared the results for each drug class to macrolides. 
    • “Among the 21,758 older adults, the antibiotics most strongly associated with serious skin conditions were sulfonamides, cephalosporins, nitrofurantoin, penicillins and fluoroquinolones. 
    • For the 2,852 hospitalized patients, the average length of stay was six days, 9.6% required transfer to a critical care unit and 5.3% died in the hospital. 
    • “When clinically appropriate, the researchers recommended prescribers use lower-risk antibiotics.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Kaiser Permanente reported a $2.1 billion net gain in the second quarter, representing a solid end to the nonprofit hospital and health plan’s financial performance in the first half of its fiscal year, according to an analyst.
    • “Kaiser’s operating margin rose to 3.1%, up from 2.9% the same time last year. The Oakland, California-based health system reported an operating income of $908 million as revenues grew at a faster clip than expenses.
    • “The second quarter marked the first time Geisinger Health’s financial performance was fully integrated into Kaiser’s earnings. While Kaiser did not break out Geisinger’s results, one analyst estimated the system contributed up to $2 billion in revenue during the quarter.”
  • and
    • “Orthopedics device company Stryker said Monday it has reached an agreement to acquire Care.ai, a company that offers artificial intelligence-based tools for hospitals. The Orlando, Florida-based startup makes patient monitoring, virtual rounding and AI-assisted decision support tools based on a network of sensors. 
    • “Stryker did not immediately respond to questions about the price or timing of the acquisition.
    • “The acquisition comes about two weeks after Stryker CEO Kevin Lobo forecast a “very active deal pipeline” for the second half of the year.”
  • Per Fierce Healthcare,
    • “Steward Health Care has agreed to sell its physicians network, Stewardship Health, to Rural Healthcare Group, which is owned by a private equity group.
    • “The embattled health system signed a definitive agreement to sell Stewardship, one of the largest primary care provider organizations in the country, for a proposed purchase price of $245 million, according to court documents filed in federal bankruptcy court Aug. 12. The court documents (document 1953 and 1954) can be found on an online portal set up for court filings and other restructuring information about Steward Health Care.
    • “RHG, an affiliate of PE firm Kinderhook Industries, will buy Stewardship through Brady Health Buyer, a company set up by Kinderhook to complete the transaction, according to court documents.
    • “Kinderhook offered $245 million in cash for Stewardship, according to court documents.
    • “The sale is subject to bankruptcy court and regulatory approval.”
  • Per BioPharma Dive,
    • “Galderma on Tuesday said the Food and Drug Administration has approved its antibody drug Nemluvio for adults with prurigo nodularis, a chronic skin condition characterized by intense itch.
    • “A subcutaneous injection, Nemluvio works by blocking cellular signaling via a cytokine called IL-31. Results from two Phase 3 clinical trials showed treatment helped to reduce itch intensity, clear skin and improve sleep, compared to a placebo.
    • “In an email, Galderma declined to disclose the price it plans to charge for Nemluvio. The company said the drug will be available in the coming weeks.” 
  • Per MedTech Dive,
    • “Medtronic said Monday it received Food and Drug Administration approval for deep brain stimulation (DBS) technology that is implanted while the patient is under general anesthetic.
    • “Surgeons traditionally perform DBS procedures, a treatment for medical conditions like epilepsy and Parkinson’s disease, while the patient is awake. However, a series of studies have shown there may be benefits to putting the patient to sleep for the procedure.
    • “Medtronic said it is the first company to receive FDA approval to offer DBS surgery while a patient is asleep or awake. U.S. surgeons have used DBS devices off-label in asleep patients for years.”
  • and
    • “Baxter has agreed to sell its Vantive kidney care business to private equity firm Carlyle Group for $3.8 billion, the companies said Tuesday. Carlyle is partnering with Atmas Health in the investment. 
    • “Carlyle formed Atmas Health in 2022 with healthcare executives Kieran Gallahue, Jim Hinrichs and Jim Prutow to focus on acquiring assets in the medical technology, life science tools and diagnostics sectors. Gallahue will become chairman of Vantive, working with Vantive CEO Chris Toth.
    • “Baxter will target annual operational sales growth of 4% to 5% after the Vantive transaction is complete.”
  • Per Stat News,
    • “The unwinding of Illumina’s ill-fated acquisition of Grail earlier this year left investors and the genomics community with a pressing question: What kind of company is Illumina going to be going forward?
    • “CEO Jacob Thaysen on Tuesday made clear that the sequencing firm, which controls about 80% of the current DNA-sequencer market, is essentially returning to its traditional role of creating instruments for researchers in academia, the biopharma industry, and health care settings.”
  • The Wall Street Journal examines the state of the hospital at home business. “Institutions say it is safe and opens hospital beds, but policymakers fear it’s too pricey and lacks strict standards.”
  • Risk & Insurance alerts us that “Employers are expanding comprehensive wellbeing programs to meet employee needs, while adopting varied cost management strategies amid rising health and drug costs, a Gallagher benchmarking report finds. * * * View the complete benchmark report, including breakouts by region and employer size, on Gallagher’s website.” 

Monday Roundup

David Ermer–CMS, COVID-19 vaccine, Medical / Rx research, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

Happy Bobby Bonilla Day!

“The calendar has turned to July 1, and that means one thing: It’s time for Mets fans everywhere to wish each other a Happy Bobby Bonilla Day! Why? On Monday, 61-year-old Bobby Bonilla will collect a check for $1,193,248.20 from the New York Mets, as he has and will every July 1 from 2011 through 2035.”

The FEHBlog is not a Mets fan. It’s a fun story.

From Washington, DC,

  • The American Hospital Association News reports,
    • “Changes to the Centers for Medicare & Medicaid Services’ Hospital Price Transparency Rule took effect July 1. Going forward, hospitals are required to use a standard machine-readable file format, which includes some new data elements, such as the negotiated rate methodology and an accuracy and completeness statement.”  
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced more than $200 million to support 42 programs across the country aimed at improving care for older Americans, including those experiencing Alzheimer’s disease and related dementias.”
    • “HRSA’s Geriatrics Workforce Enhancement Program will train primary care physicians, nurse practitioners, and other health care clinicians to provide age-friendly and dementia-friendly care for older adults.  The program also focuses on providing families and other caregivers of older adults with the knowledge and skills to help them best support their loved ones.” * * *
    • “For a full list of award recipients, visit: https://bhw.hrsa.gov/funding/apply-grant/gwep-awardees.”
  • The Washington Post lets us know,
    • “The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals, citing the company’s refusal to take down about two dozen patents for its asthma and COPD inhalers, according to confidential agency documents reviewed by The Washington Post.
    • “The FTC last week sent a civil investigative demand — effectively a subpoena — ordering Teva to provide internal communications, analysis and financial data related to the contested patents listed in a federal registry known as the Orange Book. The agency has argued that pharmaceutical companies such as Teva have wrongly made minor tweaks to their products to keep patents in the Orange Book and fend off generic competition. Teva charges hundreds of dollars for inhalers in the United States that the company sells for a fraction of the price overseas.
    • “Teva has until July 24 to cooperate with the FTC’s demand.”
  • The New York Times reports,
    • “The Supreme Court on Monday gave companies more time to challenge many regulations [under the Administrative Procedure Act], ruling that a six-year statute of limitations for filing lawsuits begins when a regulation first affects a company rather than when it is first issued.
    • “The ruling in the case — the latest in a series of challenges to administrative power this term — could amplify the effect of the blockbuster decision last week overturning a foundational legal precedent known as Chevron deference, which required federal courts to defer to agencies’ reasonable interpretations of ambiguous statutes. That decision imperils countless regulations, particularly on the environment, and advances a longstanding goal of the conservative legal movement.
    • “The vote was 6 to 3, split along ideological lines. Justice Amy Coney Barrett, writing for the conservative majority, rejected the government’s argument that the time limit to sue begins when an agency issues a rule.
    • FEHBlog note — The Supreme Court has completed its October 2023 term.

From the public health and medical research front,

  • Per an NIH press release,
    • “A Phase 1 trial testing the safety of an experimental nasal vaccine that may provide enhanced breadth of protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19, is now enrolling healthy adults at three sites in the United States. The National Institutes of Health (NIH) is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases.” * * *
    • “The study aims to enroll 60 adult participants, ages 18 to 64 years old, who previously received at least three prior doses of an FDA-approved or -authorized mRNA COVID-19 vaccine. The trial sites are Baylor College of Medicine, Houston; The Hope Clinic of Emory University, Decatur, Georgia; and New York University, Long Island. Hana M. El Sahly, M.D., at the Baylor College of Medicine Vaccine Research Center, is leading the study.” * * *
    • “More information about the trial is available at clinicaltrials.gov using the identifier NCT06441968.”
  • MedPage Today informs us,
    • “Getting an mRNA COVID-19 shot during the first trimester of pregnancy didn’t lead to an increased risk of major structural birth defects, a multisite retrospective cohort study found.
    • “Major structural birth defects occurred in 1.48% of infants after a first-trimester vaccination and in 1.41% of those without a first-trimester vaccination (adjusted prevalence ratio 1.02, 95% CI 0.78-1.33), Elyse Kharbanda, MD, MPH, of the HealthPartners Institute in Bloomington, Minnesota, and colleagues reported in JAMA Pediatrics.”
    • “Additionally, secondary analyses revealed that there were no significant differences between groups when birth defects were grouped by organ system.
    • “These findings should provide reassurance to pregnant people and their obstetric care practitioners,” the authors concluded.”
  • The Washington Post relates,
    • “People with leg amputations were able to control their prosthetic limbs with their brains in a significant scientific advance that allows for a smoother gait and enhanced ability to navigate obstacles, according to a study published Monday in the journal Nature Medicine.
    • “By creating a connection between a person’s nervous system and their prosthetic leg, researchers at the K. Lisa Yang Center for Bionics at MIT and Brigham and Women’s Hospital paved the way for the next generation of prostheses.
    • “We were able to show the first full neural control of bionic walking,” said Hyungeun Song, first author of the study and a postdoctoral researcher at MIT.”
  • Beckers Hospital Review points out,
    • “The national supply of the cancer drug cisplatin now exceeds demand, FDA Commissioner Robert Cailiff, MD, said June 28. 
    • “The drug, which treats multiple cancers, had been in shortage since February 2023. The shortage occurred after the FDA halted imports from Intas Pharmaceuticals’ manufacturing plant in India in late 2022 due to quality issues. In May 2023, 70% of cancer centers lacked sufficient cisplatin supply, according to a report from the National Comprehensive Cancer Network. 
    • “Low supplies of cisplatin and other cancer drugs have complicated treatments for many patients, with some U.S. cancer centers still struggling to maintain adequate supplies.” 
  • The Washington Post and Consumer Reports identify cures for constipation.
  • BioPharma Dive calls attention to ten clinical trials to watch in the second half of 2024.

From the U.S. healthcare business front,

  • Mercer explains why healthcare cost – and volatility – has CFOs worried. 
    • “As we head towards the third quarter of 2024, top concerns around health programs are affordability for both employees and employers, the potential impact of GLP-1s on cost trends, and the increased volatility in claims. For fully insured sponsors, claims volatility makes it difficult to predict cost from year to year, while self-insured sponsors may also experience the effects of claims volatility within a given year. Healthcare trends have been impacted by broader economic inflationary pressures with a lag, and the environment will remain challenging for some time to come. While we expect medical cost trends to be similar to last year’s, we see growing cost pressure from prescription drugs, which account for approximately one-third of total health plan costs.”
    • The article compiles Mercer’s findings from a survey of eighty CFOs.  
  • Beckers Hospital Review notes,
    • “If current trends continue, Michael Murphy, PharmD, said all payers will come to recognize pharmacists as healthcare providers by the end of the decade. 
    • “Dr. Murphy, the American Pharmacists Association’s adviser for state government affairs, said there has been “an explosion” of health plans increasing coverage for pharmacists’ services. In a June 26 blog post, he said momentum is building among commercial plans and state Medicaid fee-for-service and managed care plans. 
    • “Pharmacists are being enrolled as providers in much the same way that health plans enroll physicians, nurse practitioners and physician assistants,” Dr. Murphy said. “Pharmacists are also billing for their services in similar ways as other providers. Often, pharmacists submit the same billing codes that other healthcare providers submit for a comparable visit.”
  • STAT News reports,
    • “For 15 years, a formidable CEO-CFO duo often called “the two Tonys” ushered their St. Louis-based health system through a period of explosive growth, adding hospital after hospital until it became one of the country’s biggest health systems.
    • “The year after former CEO Anthony Tersigni and former finance chief Anthony Speranzo stepped down, their sprawling empire of roughly 140 hospitals underwent the ultimate stress test: the Covid-19 pandemic. Ascension has lost almost $4 billion on operations from fiscal 2020 through fiscal 2023, triggering deals to offload almost 30 hospitals. Just last week, Ascension said it would sell its remaining five hospitals in Alabama.
    • “They are going hard on the expense side,” said Stephen Infranco, managing director and head of the nonprofit health care team at S&P Global. “It’s a wait and see approach to how successful it is.”
    • “In a statement, Ascension spokesperson Sean Fitzpatrick said reviewing the hospital portfolio is an ongoing exercise at Ascension. “We are constantly looking for opportunities to prudently prune and grow our care delivery system in an effort to best serve patients in our communities,” he said.”
  • Per Fierce Healthcare,
    • “Amedisys, a large home health provider, plans to divest a number of care centers to an affiliate of VitalCaring Group in advance of its planned merger with UnitedHealth Group later this year.
    • “VitalCaring also acquired some UnitedHealth Group care centers in the deal, according to a filing with the U.S. Securities and Exchange Commission on Friday.
    • “The completion of the divestiture hinges on the closing of the merger between Amedisys and UnitedHealth Group, which is expected to close in the second half of 2024, Amedisys said in the SEC filing.” * * *
    • “This news is unsurprising and relatively on schedule,” wrote Matt Larew, a healthcare research analyst and partner at William Blair in an analyst note. “In May, a report originally surfaced that UnitedHealth and Amedisys were working with regulators on a divestment package of over 100 locations and a short time after it was reported that VitalCaring had emerged as the buyer.”
  • Per Healthcare Dive,
    • “Health technology startup Fabric is acquiring Walmart’s telehealth assets as the retailer exits its healthcare delivery business. 
    • “Fabric, which offers patient intake, care navigation and telehealth services, said Friday it purchased Walmart’s MeMD for an undisclosed amount. MeMD, which Walmart acquired in 2021, provides virtual behavioral, urgent and primary care benefits for 30,000 corporate partners and five million members.
    • “Walmart said in April it would close its healthcare business, citing a challenging reimbursement environment and growing operational costs that limited profitability.”
  • and
    • “Amazon is folding its telehealth marketplace into primary care chain One Medical, unifying its healthcare delivery services under a single brand — and placing One Medical in front of the eyes of engaged telehealth customers, potentially creating a new source of subscriptions.
    • “Amazon is rebranding the marketplace, previously called Amazon Clinic, to Amazon One Medical Pay-Per-Visit. The service, which automatically connects patients to a provider via virtual video or messaging for a flat fee, is also getting more affordable.
    • “Messaging visits are $29, down from around $35, and video visits are $49, down from $75.”

A Busy Thursday

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • STAT News tells us,
    • “A House committee overwhelmingly passed four bills on Thursday that would expand Medicare coverage of obesity drugs and cancer screening blood tests and place guardrails around Medicare’s discretion in covering drugs and devices approved by the Food and Drug Administration.
    • “[By a 36-4 bipartisan vote],the House Ways & Means Committee passed obesity drug coverage legislation that would offer a limited pathway for adults 65 and older to get their weight loss drugs paid for by Medicare. Right now, Medicare is prohibited from covering medications used for weight loss, like Wegovy and Zepbound. 
    • “However, the new plan is significantly more restrictive than prior proposals. It’s primarily targeted at making sure that people currently taking weight loss drugs don’t get kicked off when they enter the Medicare program, such as by turning 65.” * * *
    • “Another bill that gained even more support would expand Medicare coverage of cancer screening. The legislation passed on a 38-0 vote. 
    • “Medicare is allowed to pay for FDA-approved tests that diagnose diseases, but it doesn’t cover tests that simply screen healthy people for cancer. The bill would open the door for Medicare to pay for cancer screening tests, including Grail’s Galleri.” 
  • MedPage Today informs us,
    • “Value-based care — in which medical practices are paid based on the value of their care, not on volume — is a good idea but the Centers for Medicare & Medicaid Services (CMS) need to improve its implementation, doctors and a healthcare executive told members of the House Ways & Means Health Subcommittee.
    • “I am a proponent of the need to move to value-based care, improving quality while decreasing wasteful spending and ensuring access,” Robert Berenson, MD, an institute fellow at the Urban Institute in Washington, D.C., said at Wednesday’s subcommittee hearing on improving value-based care for patients and providers. “However, I believe that value-based payment as a mechanism to promote better care delivery has gotten off track and needs a thorough reevaluation and reformulation.”
  • Fierce Pharma relates,
    • “Leading health legislators say they are focused on reducing prescription drug prices while minimizing unintended consequences of the Inflation Reduction Act (IRA).
    • “House Rep. Scott Peters, D-California, and Rep. Mariannette Miller-Meeks, R-Iowa, shared their priorities during a program put on by The Hill and the Alliance for Aging Research.
    • “Peters stressed that the drug manufacturing industry needs to stay in the U.S., unlike how the country let chip manufacturing business slip away and go offshore. He also wants lawmakers to budget healthcare expenditures differently.
    • “Innovation might cost more money upfront, even if it saves money down the line,” he said. “In the Budget Committee, which I also serve on, we’re talking about how to think about balancing the budget over time. If we don’t think about the future costs of all these diseases, as part of that calculation, I think we’re going to miss the mark.”
  • Per CMS fact sheets,
    • On June 26, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) proposed rule, which would update Medicare payment policies and rates for Home Health Agencies (HHAs). These changes can support timely admission to home health services, which has demonstrated improvements for patient outcomes and reducing risk of hospital readmissions. 
  • and
    • “On June 27, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies and includes requests for information under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2025.
    • “For CY 2025, CMS is proposing to increase the ESRD PPS base rate to $273.20, which would increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.2%.”
  • HHS’s Office for Civil Rights announced,
    • “At the HHS Office for Civil Rights, we believe patient privacy is essential to ensuring high quality reproductive health care. HHS OCR is encouraging HIPAA covered entities and business associates to begin implementing the new HIPAA Privacy Rule to Support Reproductive Health Care Privacy to help protect patient privacy and ensure compliance later this year. To aid in this, we have compiled resources for both community members and HIPAA Covered Entities or Business Associates. 
      • “For resources to help communicate with stakeholders and community members click here.
      • “For a fact sheet summary of the rule click here (en español).
      • “To hear directly about the rule from Director Melanie Fontes Rainer click here (en español).
      • “To view a recorded briefing by Deputy Director for Health Information Privacy, Data and Cybersecurity Timothy Noonan click here.
      • “For a model attestation for a requested use or disclosure of protected health information potentially related to reproductive health care click here.
    • “The effective date of the Final Rule was June 25, 2024. This is the date that HIPAA covered entities and their business associates may begin implementing the new requirements. Covered entities and business associates are not required to comply with the new requirements until December 23, 2024, except for the new changes to the HIPAA Notice of Privacy Practices which has a compliance date of by February 16, 2026.”
  • Healthcare Dive lets us know,
    • “The U.S. Supreme Court ruled 6-3 on Thursday to allow Idaho doctors to perform abortions to stabilize a patient’s life and health. 
    • “However, the court declined to take up the fundamental legal question underlying the case: whether a federal law mandating hospitals provide medical services during emergencies [known as EMTALA] supersedes near-total state abortion bans.
    • “It is the court’s first ruling on statewide abortion restrictions since Roe v. Wade was overturned in 2022, ending the constitutional right to abortion in the United States.”
  • CMS observed,
    • “CMS’ first responsibility is to the people we serve, including anyone who steps into the emergency department of a Medicare-participating hospital. If any individual believes their EMTALA rights have been violated, they should continue to report the circumstances to CMS or their state survey agency. To the maximum extent permitted by law, we will continue to investigate complaints and hold hospitals accountable to provide the emergency stabilizing treatment that EMTALA has required for decades.”
  • The Wall Street Journal reports,
    • “The Supreme Court rejected a bankruptcy plan for OxyContin-maker Purdue Pharma that would have allocated billions of dollars from members of the wealthy Sackler family to combat opioid addiction in exchange for shielding them from civil lawsuits over their alleged role in fueling the drug epidemic.
    • “The 5-4 decision marks a victory for the minority of opioid victims who voted to reject the settlement plan because they want to continue pressing lawsuits against the Sackler family members who own Purdue, and a loss for the majority of opioid victims and state and local governments who voted to accept it.”
    • “The high court said U.S. bankruptcy law doesn’t allow for a release of the Sacklers’ legal liabilities stemming from their ownership of Purdue when not all opioid-related plaintiffs have accepted the terms offered by the company’s family owners, whose wealth has been estimated at $11 billion.” * * *
    • “Thursday’s ruling—among the highest-profile bankruptcy decisions ever from the high court—weakens the ability of corporations and their insiders to use bankruptcy to resolve mass litigation alleging they harmed consumers. 
    • “The Sacklers didn’t file for bankruptcy themselves and didn’t agree to place “anything approaching their full assets on the table” for distribution to opioid victims, [Justice Gorsuch] wrote [for the Court’s majority]. “Yet they seek a judicial order that would extinguish virtually all claims against them for fraud, willful injury, and even wrongful death, all without the consent of those who have brought and seek to bring such claims,” he wrote. 
    • “Nothing in U.S. bankruptcy law authorizes that outcome, [Justice] Gorsuch said.
  • Fierce Pharma adds,
    • “The Supreme Court decision sends the case back to bankruptcy court for future deliberations, according to a statement from Connecticut Attorney General William Tong.”

From the public health and medical research front,

  • The New York Times reports,
    • “All Americans ages 6 months and older should receive one of the new Covid-19 vaccines when they become available this fall, the Centers for Disease Control and Prevention said on Thursday.
    • “The recommendation comes as the nation faces a summer wave of Covid, with the number of infections rising in at least 39 states and territories.
    • “Most Americans have acquired immunity against the coronavirus from repeat infections or vaccine doses, or both. The vaccines now offer an incremental boost, remaining effective for only a few months as immunity wanes and the virus continues to evolve.
    • “Still, across every age group, a vast majority of Americans who were hospitalized for Covid did not receive one of the shots offered last fall, according to data presented at a meeting on Thursday of the C.D.C.’s Advisory Committee on Immunization Practices.
    • “Dr. Mandy Cohen, the agency’s director, accepted the unanimous advice of the panel on Thursday to recommend another round of immunizations.”
  • The NIH Director writes in her blog,
    • “Cancer arises when changes in genes that normally control cell division lead to unchecked growth at the expense of healthy tissues. One of the most common genetic alterations across human cancers—occurring in 95% of pancreatic cancers but also many non-small cell lung cancers, colorectal cancers, and others—is in a gene known as KRAS. While promising new treatments targeting KRAS to shrink cancerous tumors have recently gained approval, less than 40% of pancreatic cancers respond to treatment with KRAS inhibitors for reasons that aren’t well understood.
    • “There’s much more to learn about how KRAS spurs cancer growth—and how KRAS-mutant cancers resist treatment with existing KRAS inhibitors. To address this need, researchers behind two studies in Science have established the most comprehensive molecular portrait yet of the workings of KRAS and how its many downstream impacts may influence outcomes for people with pancreatic cancer. The findings could lead to new treatment approaches, including ways to potentially guide treatment for individuals with pancreatic cancer, the third leading cause of cancer-related death in the U.S.
    • “These studies, supported in part by NIH, come from a team led by Channing Der  and Adrienne Cox, together with Jeffrey Klomp, Clint Stalnecker, and Jennifer Klomp, at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill. The researchers were inspired in part by the Food and Drug Administration’s recent approval of treatments that block a mutated version of KRAS that drives many pancreatic cancers. The team was also motivated by the realization that many patients whose cancers initially respond to the new treatments relapse rather quickly as the cancers find ways to reactivate underlying growth pathways.” * * *
    • “Importantly, the researchers found that the molecular signatures they’ve uncovered may predict tumor responses in patients treated with KRAS inhibitors or ERK inhibitors. Based on their findings, they suspect that the reason so many pancreatic cancers don’t respond to KRAS inhibitors may be because the drugs simply don’t block KRAS well enough—and not because the cancers no longer depend on KRAS signals for their growth. The researchers suggest it may be beneficial to monitor these underlying molecular pathways in patients to better understand treatment outcomes and guide treatment decisions.
    • “The team plans to continue exploring the role of these and other important drivers of cancer growth and treatment resistance. Ultimately, their goal is to help advance the development of the next generation of KRAS inhibitors that will work even better for many more people with pancreatic or other KRAS-driven cancers.”
  • Health Day notes,
    • “A full third of American adults take multivitamins, despite prior studies suggesting they do little to boost health.
    • “Now, a study involving almost 400,000 people finds zero benefit from multivitamin use in helping folks live longer.
    • “Among people “without a history of major chronic diseases, we did not find evidence to support improved longevity among healthy adults who regularly take multivitamins,” concluded a team led by Erikka Loftfield. She’s with the Division of Cancer Epidemiology and Genetics at the U.S. National Cancer Institute (NCI).
    • “Her team published its findings June 26 in the journal JAMA Network Open.
  • Healio calls to our attention a study finding
    • “Alcohol intake of more than 12 g per day was associated with increased risk for hypertension.
    • “Hypertension risk plateaued at higher levels of alcohol intake for men, but risk continued to rise for women.”
  • STAT News offers a detailed article titled “By the numbers: America’s alcohol-related health problems are rising fast.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Walgreens is pulling back its focus on healthcare services after the strategic shift failed to bolster the struggling retailer’s financial health.
    • “Walgreens plans to reduce its stake in value-based medical chain VillageMD, and will no longer be the company’s majority owner, CEO Tim Wentworth told investors on a Thursday morning call after announcing third quarter earnings below analyst expectations.
    • “Walgreens also plans to close a “significant portion” of its roughly 8,700 stores in the U.S., Wentworth said. The company didn’t share a specific figure, but said it is reviewing one-quarter of its stores that are underperforming financially. Walgreens has already closed hundreds of stores over the past few years.” * * *
    • “Walgreens plans to launch a retail pharmacy action plan to improve customer experience in its stores, better align its pharmacy and healthcare businesses and focus on reliable products in areas like women’s health, Wentworth said.
    • “The company is also in discussions with health insurers and pharmacy benefit managers to change how its pharmacies are paid, to create more stability in a challenging reimbursement environment.”
  • Modern Healthcare reports,
    • “At-home emergency care is gaining momentum — and could cost millions less — but reimbursement challenges create an access barrier for some patients.
    • “Deploying healthcare in patients’ homes gained traction during the COVID-19 pandemic as a way to ease overcrowding at hospitals and prevent the virus from spreading. Emergency department care at home lets patients bypass the waiting room through referrals from hospitals or primary care providers if they determine patients do not have life-threatening illnesses or injuries. While many private insurers reimburse for such care, traditional fee-for-service Medicare and Medicaid do not pay for it as a stand-alone service.
    • “Emergency department-at-home programs deploy paramedics or nurses to check vital signs, draw blood and take x-rays with portable imaging devices. Physicians supervise the visits via telehealth, then refer patients to primary care providers for further treatment or to hospital emergency departments if more complex care is needed.
    • “Healthcare technology company Medically Home and primary care provider Atrius Health, a division of UnitedHealth Group’s Optum Health, offer emergency department-care-at-home through a partnership in the Boston area. A study they published last week in the New England Journal of Medicine found more than 83% of 3,668 patients who received emergency care at home over two years did not require a trip to the hospital, saving Atrius approximately $4.5 million.
    • “Medically Home launched its service in 2020 and has served approximately 7,000 patients through contracts with three provider groups, including Atrius. The primary care provider has value-based care contracts with most of its patients and takes on the full risk for their care.”
  • FEHBlog observation: Intriguing!
  • Per Fierce Healthcare,
    • “Nineteen rural Minnesota hospitals and their 50-plus clinics have banded together to form a clinically integrated network (CIN) serving more than 750,000 people.
    • “The so-called Headwaters High-Value Network, announced Thursday, stitches the independent hospitals’ services together so that Minnesotans can coordinate their care across care sites. Together, the member groups employ about 9,000 people and bring in $1.3 billion of annual net revenue.
    • “Members of the network also said the approach will help their hospitals control rising care costs through reduced administrative burden and shared services. The CIN said it is “in discussions” with other interested rural Minnesota hospitals and “expects to grow.”
  • Beckers Hospital Review identifies the ten best states for hospital experience. Nevada leads the pack.
  • Beckers Hospital Review adds,
    • “Mark Cuban Cost Plus Drug Co. will serve as a wholesale drug distributor for all 71 hospitals affiliated with Community Health Systems, the organizations announced June 27. 
    • ‘Cost Plus Drugs launched the wholesale services in early 2024, but for the first time, the company is rolling out the offering to a large health system.
    • “The pharmaceutical company has direct relationships with 38 of the 40 largest generic manufacturers and multiple secondary distributors, according to Cost Plus Drugs’ CEO and co-founder, Alex Oshmyansky, MD, PhD.

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–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.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, NIH, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital Association New tells us,
    • The House Energy and Commerce Oversight and Investigations subcommittee June 4 hosted a hearing to discuss oversight of the 340B Drug Pricing Program. AHA sent a letter to the subcommittee for the hearing, urging Congress to protect the program and highlighted its value to hospitals and health systems.
  • Roll Call offers more details on this policy issue.
  • Per a Health and Human Services press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), today welcomed 10 new states into the Certified Community Behavioral Health Clinic (CCBHC) Medicaid Demonstration Program, after they successfully developed the necessary state-level infrastructure and worked with providers in their states to develop programs that meet CCBHC standards: Alabama, Illinois, Indiana, Iowa, Kansas, Maine, New Hampshire, New Mexico, Rhode Island and Vermont. The CCBHC Medicaid Demonstration Program provides states with sustainable funding that helps them expand access to mental health and substance use services, supporting President Biden’s Unity Agenda and the Biden-Harris Administration’s efforts to tackle the country’s mental health and addiction crises. The expansion of the program directly supports the President’s national strategy to transform our behavioral health system and builds on the Administration’s previous work to build a better crisis continuum of care, including through the transition to the 988 Suicide & Crisis Lifeline, add a new mobile crisis benefit to Medicaid and new crisis codes to the Medicare program.”
  • NBC News reports,
    • A Food and Drug Administration advisory panel on Tuesday declined to recommend the approval of MDMA as a treatment for post-traumatic stress disorder, a major setback for advocates who have long pushed to include psychedelics in treating mental health disorders.
    • The two votes — one for the treatment’s efficacy and one for its safety, by the agency’s Psychopharmacologic Drugs Advisory Committee — marked the first time that FDA advisers have considered a Schedule I psychedelic for medical use. If approved by the FDA, it would be the first new treatment for PTSD in more than two decades.
    • The votes reflected panel members’ struggle to balance the need for new PTSD treatments against serious concerns about the data submitted by drugmaker Lykos Pharmaceuticals, which was marred by inconsistencies, poor study design and allegations of misconduct.
    • “It sounds like MDMA has really impacted a number of people in positive ways, but it seems that there are so many problems with the data,” said Melissa Decker Barone, an adjunct assistant professor in the department of psychiatry at the University of Maryland School of Medicine. * * *
    • Last week, the Institute for Clinical and Economic Review, a non-profit group that evaluates the cost of drugs, said patients and providers in the trial treated psychedelics “more like a religious movement than like pharmaceutical products.” * * *
    • “The decision will now go to the FDA, which is expected to make a final ruling by August 11. The committee’s vote is only a recommendation, and the agency doesn’t have to follow its advice, although it usually does.”
  • Reuters adds,
    • “The FDA’s staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain. * * *”The FDA’s staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain. * * *
    • “The FDA staff’s review for updating viral strains for vaccines in the U.S. differs from that of the World Health Organization’s advisers, who in April recommended targeting only the JN.1 strain.
    • “Since then, the subvariant KP.2 has become the dominant strain in the U.S., estimated to account for about 28.5% of cases over a two-week period ended May 25, according to data from the U.S. Centers for Disease Control and Prevention.”
  • Healthcare Dive informs us,
    • “Scan Health Plan won a lawsuit that alleged the federal government had improperly calculated its 2024 Medicare Advantage star ratings, which it argued could cost the insurer millions of dollars. “Scan Health Plan won a lawsuit that alleged the federal government had improperly calculated its 2024 Medicare Advantage star ratings, which it argued could cost the insurer millions of dollars. 
    • “The case centered around recent changes in how the CMS determined quality measures for the private Medicare plans. Scan alleged the agency didn’t follow its stated methodology, causing its rating to drop “precipitously” to 3.5 stars and risking $250 million in quality bonus payments. 
    • “The U.S. District Court for the District of Columbia ruled for the California-based insurer Monday, barring the federal government from using Scan’s original 2024 Star Rating for quality bonus decisions.”

From the public health and medical research front,

  • The New York Times reports,
    • “Surgeons removed the kidney of a genetically engineered pig from a critically ill patient last week after the organ was damaged by inadequate blood flow related to a heart pump that the woman had also received, according to officials at NYU Langone Transplant Institute.”Surgeons removed the kidney of a genetically engineered pig from a critically ill patient last week after the organ was damaged by inadequate blood flow related to a heart pump that the woman had also received, according to officials at NYU Langone Transplant Institute.
    • “The patient, Lisa Pisano, 54, who is still hospitalized, went back on kidney dialysis after the pig’s organ was removed. She lived with the transplanted organ for 47 days, Dr. Robert Montgomery, director of the institute, said. The kidney showed no signs of organ rejection.
    • “Lisa is in stable condition, and her left ventricular assist device is still functioning,” Dr. Montgomery said, referring to the heart pump. “We are hoping to get Lisa back home to her family soon.”
  • Health Day lets us know,
    • “As the H5N1 avian flu continues to spread among dairy cows in the United States, nearly 5 million doses of flu vaccine are now being prepared for possible use in humans.
    • “Since the outbreak in livestock began this spring, bird flu has been confirmed in three humans who worked on dairy farms in Texas and Michigan, and health experts are concerned the virus could mutate to the point where it could spread easily among humans.
    • “In response, vaccine maker CSL Seqirus announced last week that it has been tasked with making the additional doses of flu vaccine at its North Carolina plant.
    • “It utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response within six months of a pandemic declaration,” the company noted in a news release.”
  • ABC News relates,
    • “Cases of whooping cough are on the rise across the United States, data from the Centers for Disease Control and Prevention shows. “Cases of whooping cough are on the rise across the United States, data from the Centers for Disease Control and Prevention shows.
    • “There have been at least 4,864 whooping cough cases reported this year. This is nearly three times higher than the 1,746 cases reported at the same time last year.
    • “The number of cases for 2024 is similar to those seen in 2018-2019, before the COVID-19 pandemic.
    • “The national trends mirror those seen in many U.S. states. The Oregon Health Authority said Thursday that 178 cases have been reported as of May 29, a 770% increase from the 20 cases reported by at the same time in 2023, according to local ABC News affiliate KATU. * * *
    • “There are two types of vaccines used today to protect against whooping cough: diphtheria, tetanus, and pertussis (DTaP) vaccine for babies and children younger age 7 and tetanus, diphtheria, and pertussis (Tdap) vaccines for children aged 7 and older, adults and pregnant women.
    • “People often think ‘Well once you get vaccinated you have lifelong immunity,’ and that’s actually not the case. You certainly need to get those booster doses,” Madad said.”
  • Beckers Hospital Review points out
    • “Mississippi is the unhealthiest state in the nation for older adults in 2024, according to the United Health Foundation’s 12th annual “America’s Health Rankings Senior Report.”
    • “The May 30 report provides a comprehensive look at the health and well-being of Americans 65 and older.   
    • “State rankings were derived from 35 measures across five categories of health: social and economic factors, physical environment, behaviors, clinical care and health outcomes. The full methodology can be viewed here.“
  • The National Institutes of Health shared their most recent research insights.
  • NIH announced in various press releases,
    • “Two clinical trials have launched to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months. The studies are sponsored and funded by Gilead Sciences, Inc., and implemented through the HIV Prevention Trails Network (HPTN). The HPTN is supported by grants from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) as well as co-funding from NIDA and other NIH institutes.”
  • and
    • “A five-minute cognitive assessment coupled with a decision tree embedded in electronic medical records, known as 5-Cog, improved dementia diagnosis and care, based on a clinical trial funded by the National Institutes of Health (NIH) and conducted in an urban primary care setting. Researchers evaluated the system among 1,200 predominantly Black and Hispanic American older adults who presented to primary care with cognitive concerns. The findings appear in Nature Medicine. * * *
    • “5-Cog combines three metrics designed to test memory recall, the connection between cognition and gait, and the ability to match symbols to pictures. Importantly, these tests are easy to perform, relatively quick, and are not affected by reading level or ethnic/cultural differences among patients. * * *
    • “Cognitive impairment is often difficult to diagnose in the busy primary care setting and, as a result, beneficial care plans are likely underutilized. This can result in lack of detection, which delays the start of support services and critical planning. Underdiagnosis is even more prevalent among older Black and Hispanic patients compared to white patients, suggesting this tool may be even more valuable to the populations represented in the study.”
  • and
    • “For military members and veterans who have been diagnosed with post-traumatic stress disorder (PTSD), adding a service dog to their usual care could reduce the severity of PTSD symptoms, feelings of anxiety, and lower depression while enhancing their quality of life and psychosocial functioning, according to a study funded by the National Institutes of Health.”For military members and veterans who have been diagnosed with post-traumatic stress disorder (PTSD), adding a service dog to their usual care could reduce the severity of PTSD symptoms, feelings of anxiety, and lower depression while enhancing their quality of life and psychosocial functioning, according to a study funded by the National Institutes of Health.
    • “The trial, which is the largest nationwide study comparing service dog partnerships to usual care alone, included 156 military members and veterans diagnosed with PTSD. Participants were recruited through the database of K9s For Warriors, an accredited non-profit service dog provider. Under U.S. federal law(link is external), service dogs are “individually trained to work or perform tasks for people with disabilities.”

From the U.S. healthcare business front,

  • Per MedTech Dive,
    • “Abbott received clearance from the Food and Drug Administration for an over-the-counter glucose monitor. “Abbott received clearance from the Food and Drug Administration for an over-the-counter glucose monitor. 
    • “The device, called Lingo, first debuted in the U.K. last year as a sensor for people who don’t have diabetes to track glucose spikes. Abbott hopes to bring it to the U.S. but has shared few details about its plans. 
    • “With the recent FDA clearance, Abbott will compete with Dexcom for a new category of over-the-counter glucose monitors. Dexcom received FDA clearance for the first over-the-counter CGM in March.”
  • Per Healthcare Dive,
    • “Steward Health Care is aggressively courting new debtor-in-possession lenders to stay afloat amid its Chapter 11 restructuring process. Without additional capital, the health system says it will run out of funds by June 14.
    • “Medical Properties Trust, Steward’s landlord and initial DIP financier, appears unlikely to step up to the plate to offer more funds.
    • “The Dallas-based health system, which employs 30,000 people across eight states, declared bankruptcy last month. At the time, the real estate investment trust put up $75 million of DIP financing and said it might offer up to $225 million more, contingent upon successful asset sales.
    • “But MPT has since shown little interest in providing additional financial support for Steward. As of Friday, Steward’s attorneys told the court that MPT had made no further commitment to pony up funds, leaving the health system in immediate need of new funding.”

 

Midweek Update

David Ermer–CDC, Congress, COVID-19 vaccine, Generative AI, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • The New York Times reports,
    • “The chairmen of two Senate committees overseeing health policy, concerned about companies “padding their own profits” at the expense of patients, are looking into the practices of a data analytics firm that works with big insurers to cut payments to medical providers.
    • “The firm, MultiPlan, recommends what it says are fair payments for medical care, but the firm and the insurers can collect higher fees when payouts are lower. This business model could “result in an improper conflict of interest,” the chairmen of the two committees, Ron Wyden of Oregon and Bernie Sanders of Vermont, wrote in a letter to the firm’s chief executive that was released on Tuesday.
    • “The senators called on MultiPlan to meet with the committees’ staffs to discuss an investigation last month by The New York Times that found the firm’s pricing tools could leave patients with unexpectedly large bills when they see doctors outside their health plans’ networks.”
  • Govexec tells us,
    • “The Office of Personnel Management last week gave agencies a reminder that as campaign season approaches, officials should be vigilant against efforts to “burrow” political appointees into career positions in the federal government’s competitive and Senior Executive services.
    • “In a memo to agency heads, OPM’s associate director for merit system accountability and compliance Mark Lambert and associate director for workforce policy and innovation Veronica Hinton addressed the controversial practice, which is legal, albeit with a strict set of regulations to ensure political appointees are qualified for career roles they’re lined up for.”
  • KFF introduced,
    • “A new KFF resource—Health Policy 101—explains the basics on a wide range of topics about health programs and policy in the United States, such as Medicare and Medicaid, the Affordable Care Act, health care costs and affordability, women’s health issues, and the politics of health care. Health Policy 101 chapters are available online and can be downloaded in PDF format. The “101” was created to serve as a mini “textbook” for faculty and students interested in health policy. Dr. Drew Altman, KFF’s president and CEO, is the editor of the 101 series.”

From the public health and medical research front,

  • MedPage Today informs us,
    • “The updated monovalent XBB.1.5 COVID-19 vaccines were effective against Omicron subvariants circulating during the most recent respiratory virus season, but their effectiveness waned over time, according to a brief report.
    • “The three vaccines updated to target the SARS-CoV-2 XBB.1.5 subvariant — Moderna’s and Pfizer-BioNTech’s mRNA vaccines and the Novavax vaccine — were 66.8% effective against hospitalization at 4 weeks, decreasing to 57.1% after 10 weeks, wrote Dan-Yu Lin, PhD, of the UNC Gillings School of Global Public Health in Chapel Hill, North Carolina, and colleagues.
    • “Vaccine effectiveness against infection was about 52% after 4 weeks, decreasing to 33% after 10 weeks, and to 20% after 20 weeks, the New England Journal of Medicineopens in a new tab or window correspondence showed.
    • “We expected these vaccines to be effective, especially against hospitalization and death. We also expected the effectiveness to decline over time,” Lin told MedPage Today. “However, we didn’t know beforehand the levels of effectiveness or the duration of protection.”
  • The Wall Street Journal shares the view of readers who have used GLP-1 drugs.
    • “Hundreds of readers responded in the comments space and by email to Bradley Olson’s essay about his experience using a GLP-1 drug for weight loss. Readers shared stories about their own attempts to lose weight, journeys that often took place over the course of decades and included nonmedicinal strategies before the advent of GLP-1 drugs. Our readers made overwhelmingly positive comments about the medications, and in general found that the transformational impact of the GLP-1 drugs made such difficulties as getting prescriptions filled and side effects bearable. Some readers who have struggled to lose weight wrote that they found inspiration in Olson’s essay to consider trying a medical solution.” 
  • Per BioPharma Dive,
    • “A new kind of antidepressant eased symptoms and improved sleep among adults enrolled in a large Phase 3 trial, Johnson & Johnson, the drug’s developer, said Wednesday.
    • “J&J is studying the drug, called seltorexant, as an “adjunctive” therapy to background treatment with other antidepressants like SSRIs. The company’s trial enrolled adults with major depressive disorder as well as insomnia, which often accompanies depression and isn’t well treated by SSRIs.
    • “J&J didn’t disclose detailed data in its Wednesday statement. But the company did share the trial met all of its primary and secondary goals, noting the improvement in depressive symptoms among seltorexant-treated participants at study day 43 was both statistically significant and clinically meaningful.”
  • The New York Times dives into recent research on the sense of taste.
    • “The perception of taste is a remarkably complex process, starting from that first encounter with the tongue. Taste cells have a variety of sensors that signal the brain when they encounter nutrients or toxins. For some tastes, tiny pores in cell membranes let taste chemicals in.
    • “Such taste receptors aren’t limited to the tongue; they are also found in the gastrointestinal tract, liver, pancreas, fat cells, brain, muscle cells, thyroid and lungs. We don’t generally think of these organs as tasting anything, but they use the receptors to pick up the presence of various molecules and metabolize them, said Diego Bohórquez, a self-described gut-brain neuroscientist at Duke University. For example, when the gut notices sugar in food, it tells the brain to alert other organs to get ready for digestion.”
  • Healio lets us know,
    • “Women who get an epidural during delivery appear to have a marked reduction in serious complications the first few weeks after giving birth, a new study shows.
    • “A painkilling epidural can reduce risk by 35% in women for complications like heart attack, heart failure, blood infection and hysterectomy that can occur as a result of delivery, researchers reported May 22 in the BMJ.
    • “And the risk declines even more for women with known risk factors for these complications such as obesity, other health problems or prior delivery, researchers said.
    • “For those women, an epidural can reduce their risk of complications by 50%, compared to a 33% risk reduction in those without such factors.
    • “And women delivering preterm had a risk reduction of 47%, results show.”
  • and
    • “Researchers found that a questionnaire successfully identified patients with STIs who can be safely evaluated for penicillin allergy by skin test or by a two-step graded oral challenge, according to a study.
    • “Providers caring for clients with STIs are often faced with clients reporting a history of penicillin allergy (up to 15% of clients). Penicillin remains the drug of choice for the treatment of all stages of syphilis,” Rebecca A. Lillis, MD, associate professor at the Louisiana State University School of Medicine, told Healio.
    • “Ceftriaxone is the drug of choice for treatment of gonorrhea and often avoided in clients who report a penicillin allergy, resulting in suboptimal care,” she said.”
  • The National Institutes of Health announced,
    • “A team of researchers funded by the National Institutes of Health have generated the first complete chromosome sequences from non-human primates. Published in Nature(link is external), these sequences uncover remarkable variation between the Y chromosomes of different species, showing rapid evolution, in addition to revealing previously unstudied regions of great ape genomes. Since these primate species are the closest living relatives to humans, the new sequences can provide insights into human evolution.”

From the U.S. Healthcare business front,

  • Per Fierce Healthcare,
    • “A significant gap exists between health plans that have the highest consumer experience scores and those with the lowest, according to a new survey from J.D. Power.
    • “The consumer insights firm released its annual look at commercial health plans and found that overall satisfaction lands at a score of 595 out of 1,000 points, an increase of three points from 2023’s survey. However, the analysts found a 79-point gap between plans with the highest and lowest scores.
    • “Further, plans with the best consumer satisfaction ratings are getting better, while the lowest-performing plans are sliding. Scores at the highest performers increased by 20 points, while lower scores declined by eight points.
    • “In many cases, employer-sponsored health insurance is consumers’ primary window into the healthcare system,” said Christopher Lis, Ph.D., managing director of global healthcare intelligence at J.D. Power, in a press release. “Access to care, cost of care, chronic condition management—the central pillars of the consumer healthcare experience—are all heavily influenced by commercial health plans.”
  • and
    • “The proportion of hospitals meeting the Office of the National Coordinator for Health IT’s (ONC’s) bar for interoperability rose substantially from 2018 to 2023, though a focus on day-to-date data exchange will be necessary to fill some remaining gaps.
    • “According to a recent data brief from ONC, 7 in 10 nonfederal acute care hospitals reported either “routinely” or “sometimes” engaging in all four measured domains of electronic health information interoperability: sending data (92%), receiving data (87%), querying data from outside their organization (84%) and integrating outside data into their records without manual entry (78%).
    • “The 70% top line is an improvement from the 23% of 2014 and the 46% of 2018. Interoperability remained flat at 70% from 2022 to 2023, though the ONC noted that its surveys for the two years were fielded nearly back-to-back to catch up following pandemic polling delays.”
  • Beckers Payer Issues points out,
    • “UnitedHealth Group is running around 500 use-case applications for AI across the organization, CEO Andrew Witty told investors. 
    • “Speaking at a conference on May 29, Mr. Witty said some of the company’s AI efforts are “low-hanging” opportunities aimed at speeding up administrative processes. 
    • “It’s not Einstein opportunities,” he said. “These are relatively straightforward. Some of them are already underway. They play out in areas like speed, allowing call handlers to deal with issues faster than they used to.” 
    • “Heather Cianfrocco, CEO of Optum, told investors Optum’s AI efforts are focused in two areas. 
    • “One is administrative support, particularly for clinicians, giving clinicians time back at home or in the office,” Ms. Cianfrocco said. “The second area I would highlight is identifying disease progression, or emerging disease, faster.”