Tuesday Tidbits

NIH

Tuesday Tidbits

David Ermer–ACA, CDC, FDA, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Yesterday, the Supreme Court invited the Solicitor General to submit a brief expressing her views on the 10th Circuit’s decision in PCMA v. Mulready which is favorable to ERISA and Medicare preemption of state PBM reform laws.
  • The Solicitor General typically submits a brief favoring Supreme Court review no later than December so that the Court can hear the case in its current term. If the Solicitor General opposes Supreme Court review, her brief likely will be submitted next April.
  • The FEHBlog hopes that the Solicitor General files an April 2025 brief.
  • Also yesterday, the Defense Department announced a one-year pilot program to provide no-cost supplemental health support services to DoD civilian employees serving in Japan after a yearlong effort to identify and address concerns regarding access to medical care.
    • “This pilot is called the Pilot Health Insurance Enhancement for DoD Civilian Employees in Japan and will assist [11,000] eligible civilian employees with health care navigation and upfront costs associated with accessing Japan’s healthcare system.
    • “To be eligible, the employee must be enrolled in a participating health plan through the Federal Employees Health Benefits (FEHB) program. The enrollment window for eligible employees will be the Federal Benefits Open Season, which runs this year Nov. 11 through Dec. 9. Federal Benefits Open Season allows federal civilians to enroll in or change health care options.
    • “The services provided under this pilot will begin Jan. 1, 2025, when participants can use the services and access support through a call center. The call center will be open 24/7 and staffed with bilingual service representatives who will assist callers with identifying their needs, make appointments with provider offices, and issue payment guarantees up front. Dependents are not eligible for services during the pilot, which runs through Sept. 29, 2025. * * *
    • “The Office of the Assistant Secretary of Defense for Health Affairs will oversee the pilot program and has awarded a $4.2 million contract to International SOS Government Services Inc., which is also the prime contractor for the TRICARE Overseas Program. The contract for this pilot is being funded by the military departments, defense agencies and DoD field activities that have civilian employees working in Japan.
    • “Active-duty service members and TRICARE Prime beneficiaries have prioritized access to health care in military hospitals and clinics based on current federal law and DoD policy. DoD civilians who are not TRICARE beneficiaries may use military health facilities on a space-available basis. [This unfortunate 2023 policy change led to this pilot.]
    • “Agreements with FEHB insurance carriers who currently provide coverage for DoD civilian employees in Japan will be established to provide direct billing agreements. Non-appropriated Fund (NAF) employees are eligible for this program if enrolled in an Aetna International plan.”
  • The FEHBlog finds it odd that the DOD pilot does not cover eligible family members.
  • Health Affairs Forefront provides even more details on the lengthy proposed 2026 Notice of Benefit and Payment Parameters for the ACA marketplace released last Friday.
  • Federal News Network tells us,
    • “After making improvements for two months, the Office of Personnel Management retirement backlog saw a decline in claims received and processed claims for the month of September.
    • “OPM received 5,618 claims in September, 1,465 less than the month of August’s claims received. OPM processed 6,302 claims in September, 1,400 less than in August.”
    • That appears to be a wash to the FEHBlog.

From the public health and medical research front,

  • American Hospital News informs us,
    • “The Centers for Disease Control and Prevention last week confirmed the first two human cases of H5 bird flu in California. The individuals were workers who had contact with infected dairy cows, CDC said. There have been 16 total human cases of H5 bird flu reported in humans across the country this year, with six being linked to exposure to sick or infected dairy cows, nine with exposure to infected poultry, and one case in Missouri with an origin that has yet to be determined. The CDC’s risk assessment of a bird flu outbreak for the general public remains low.”
  • Per BioPharma Dive,
    • “Vaccine maker GSK unveiled new data Tuesday showing its respiratory syncytial virus vaccine Arexvy protected older adults over three seasons against disease caused by infection.
    • “Across the entire time period, one dose of Arexvy was 63% effective against RSV broadly, and 67% effective against severe disease, GSK said. However, the shot’s efficacy waned, falling to an estimated 48% in the third season alone.
    • “Currently, the Centers for Disease Control and Prevention doesn’t recommend a second RSV vaccine dose. While GSK described the three-season data as evidence of the shot’s “significant health impact,” it said that “over time, revaccination is expected to be required to maintain an optimal level of protection.”
  • CNN reports,
    • “A new study found that having your arm in the wrong position during blood pressure checks — either at home or the doctor’s office — can result in readings “markedly higher” than when your arm is in the recommended position: appropriately supported on a table with the middle of the cuff positioned at heart level.
    • “This suggests that not consistently having your arm positioned and supported appropriately during a blood pressure reading might result in a misdiagnosis of high blood pressure, which some experts worry could possibly lead to unnecessary treatment.
    • “The study, published Monday in the journal JAMA Internal Medicine, found that having your arm resting in the lap during a blood pressure reading can lead to an overestimated systolic blood pressure measurement by 3.9 mm Hg and overestimated diastolic reading by 4 mm Hg. And having your arm hang by your side can lead to an overestimated systolic reading by 6.5 mm Hg and overestimated diastolic reading by 4.4 mm Hg.”
  • Per Healio,
    • “A blood test for men at the time of a metastatic prostate cancer diagnosis may predict treatment response and survival, according to study results.
    • “The test could help oncologists decide which patients should receive standard treatment and who might derive more benefit from a clinical trial, researchers concluded.”
  • The Washington Post lets us know,
    • “Children should spend up to two hours a day outside to reduce their risk of myopia, or nearsightedness, according to a new consensus report from the National Academies of Sciences, Engineering and Medicine. At least one of those hours should take place during the school day, the report says.
    • “Myopia is a condition in which distant objects are blurry but close-up objects look clear. The National Academies report cites research indicating a significant rise in myopia worldwide.”
  • The National Institutes of Health posted the latest issue of “Women’s Health In Focus at NIH, Volume 7, Issue 3, 2024.” This is a quarterly publication of NIH’s Office of Research on Women’s Health.
  • The International Foundation of Employee Benefit Plans offers flu season advice to employers.

From the U.S. healthcare business front,

  • The KFF-Peterson Health Tracker shares a “chart collection explores how health spending is expected to grow in coming years, based on National Health Expenditure (NHE) projections from federal actuaries. A related chart collection explores how U.S. health spending has changed over time using historical data, and an interactive tool allows users to explore health spending changes over time.”
  • Modern Healthcare reports,
    • “Four large nonprofit health systems created a new company to use as a testing ground for boosting access to drugs, improved care coordination for Medicare Advantage patients and streamlined billing processes.
    • “Baylor Scott & White Health, Memorial Hermann Health System, Novant Health and Providence are the founding members of Longitude Health. Each health system has made an undisclosed financial commitment to fund Longitude, which is a Delaware-based holding company owned and managed by its founders.
    • “The health system-led, for-profit entity plans to form three operating companies that will essentially act as startups on pharmaceutical development, care coordination and billing. Chief executive officers of the participating systems make up the Longitude board, along with Longitude CEO Paul Mango, former chief of staff at the Centers for Medicare and Medicaid Services.
    • “Executives hope to create additional operating companies and attract more health systems and investors over the next year.”
  • Beckers Hospital Review adds, “The U.S. spent $99 billion on both oral and clinician-administered cancer therapies in 2023, according to a report published in April by analytics firm IQVIA. As cancer drug prices continue to increase, spending is projected to grow.”
  • Per Fierce Pharma,
    • “As the eastern U.S. braces for another storm in the form of Hurricane Milton, at least one major drugmaker is stepping up to support Florida locals and preserve access to critical medical supplies and drugs.
    • “Pfizer—which opened a global hub in Tampa, Florida, in 2021—is setting out to bolster emergency services, pool donations and ease medical supply needs as Milton touches down this week, the company’s CEO, Albert Bourla, Ph.D., said in a post on X (formerly Twitter) Tuesday.
    • “Like many people, I have watched with a heavy heart as the scale of the damage caused by Hurricane Helene has become fully evident,” the chief executive said. “Now it seems Hurricane Milton is heading toward the Tampa area, where we have a major Pfizer facility.”
    • “In light of the impending natural disaster, Bourla said Pfizer is pledging all it can to support the community during this trying time.”
  • Per MedTech Dive,
    • “Baxter said Monday it has made progress restoring a North Carolina manufacturing plant damaged by Hurricane Helene. 
    • “Rain and storm surge from Hurricane Helene flooded the plant and damaged access bridges. So far, Baxter has not identified any structural damage to the facility. The Marion, North Carolina, site is the company’s largest manufacturing facility and produces dialysis solutions and IV fluids.
    • “Baxter is resuming shipments of dialysis products to hospitals and patients after a temporary hold last week.”
  • and
    • “Mercury Medical has recalled 1,300 emergency breathing support devices in response to a problem that can affect ventilation of the patient.
    • “The Food and Drug Administration, which published an alert about the problem Monday, categorized the action as a Class I recall. Mercury asked customers to stop the use and distribution of the affected devices.
    • “No reported injuries or deaths have been associated with the issue, but the FDA said affected products could cause serious adverse health consequences.”
  • Beckers Hospital Review points out,
    • “A group representing companies that produce copycat versions of Eli Lilly weight loss medications has filed a lawsuit against the FDA following the agency’s recent decision to remove the drugs from its shortage list, Bloomberg reported Oct. 7. 
    • “The Outsourcing Facilities Association, along with compounding pharmacy FarmaKeio Superior Custom Compounding, alleged the FDA acted arbitrarily and failed to provide prior notice regarding its decision. 
    • “The plaintiffs asserted that the shortage of Lilly’s drugs is not truly over and argued that the FDA’s action limits patient access to essential medications. The lawsuit seeks to overturn the FDA’s removal of Lilly’s weight loss drugs from the shortage list. 
    • “With the FDA announcement, many patients who relied on compounded versions of the medications now face the choice of switching to higher priced brand-name medications or seeking alternatives from Novo Nordisk.” 
  • Per SHRM, Mercer Consulting predicts
    • “Employers may be cautious about pay due to economic concerns, but they are planning to stay consistent with salaries next year—at least for now.
    • “On average, U.S. employers are budgeting for 3.3% merit increases and 3.6% increases for their total salary budgets for nonunionized employees, according to new data from consulting firm Mercer, which surveyed more than 1,100 employers to gauge what pay will look like in 2025. These numbers are the same as the actual pay increases that employers delivered in 2024.
    • “Mercer’s analysis also found that, in addition to remaining consistent with salary increases, employers are planning to promote just under 10% of their employees in 2025. For companies with a separate promotion budget, the average promotion increase budget for 2025 is 1%, down slightly from 1.1% in 2024.
    • “There are variations in compensation projections across industries, Mercer found. For example, technology and life sciences reported above-average compensation budgets, with merit and total increase budgets at 3.5% and 3.9%, respectively. On the other end of the spectrum, retail and wholesale reported merit and total increase budgets of 3.1% and 3.3%, respectively.”

Thursday Miscellany

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

From Washington, DC

  • The Wall Street Journal reports,
    • “Eli Lilly has finally made enough supply of its popular medicine tirzepatide to meet soaring demand, which should help the company widen its share of the booming weight-loss drug market.
    • “The Food and Drug Administration said late Wednesday that Lilly had resolved the shortage. It had started in 2022, just months after the drug was introduced with the brand Mounjaro for diabetes. Tirzepatide was approved as Zepbound in late 2023 as a weight-loss treatment.
    • ‘The milestone means that compounding pharmacies that make knockoff versions of tirzepatide will likely face new restrictions on what they can produce.
    • “The compounding pharmacies had legal cover to sell knockoff tirzepatide as long as it was on the FDA shortage list, and many patients turned to these products as a cheaper alternative. Yet in announcing the end of the shortage, the FDA said federal law bars compounders from making copies of drugs that aren’t on the shortage list, though they may make certain amounts.
    • “This essentially precludes compounded tirzepatide from being produced commercially,” BMO Capital Markets analysts said.” * * *
    • “Lilly’s rival, Novo Nordisk, also has been expanding its production capacity to resolve shortages of a similar drug, semaglutide, sold as Ozempic for diabetes and Wegovy for weight loss. The lowest dose of Wegovy is currently in shortage, while higher Wegovy doses and all Ozempic doses are available, according to the FDA shortage list.”

  • Per Healthcare Dive,
    • “A bipartisan group of two dozen lawmakers is urging the Biden administration to extend telehealth prescribing flexibilities for opioid use disorder treatment. 
    • “The representatives, led by Reps. Annie Kuster, D-N.H., and Carol Miller, R-W.Va., argued flexibilities allowing telehealth prescriptions of buprenorphine without an in-person visit has increased access to treatment and reduced overdoses.
    • “But those flexibilities are set to expire at the end of the year. Lawmakers also raised concerns that the Drug Enforcement Administration could propose more stringent requirements for telehealth prescriptions of buprenorphine, a medication that be used to treat opioid use disorder, limiting its use just as overdose deaths have begun to decline.” 
  • STAT News reports,
    • “A key aspect of the Democrat-passed law to lower drug prices is significantly more expensive to the government than expected, according to nonpartisan budget experts in Congress.
    • “The redesign of the Medicare Part D drug benefit will cost $10 billion to $20 billion more next year than the Congressional Budget Office initially projected. That office estimates that a separate recently announced program to pay insurers to lower drug premiums will cost $5 billion.”
  • Per Fierce Healthcare,
    • The Biden administration could stand to take a firmer hand on hospital price transparency, especially when it is unclear whether the price data being published are even accurate, the Government Accountability Office (GAO) wrote in a Wednesday report.
      The Centers for Medicare & Medicaid Services (CMS) has required hospitals to post the prices for numerous services annually and this past summer raised the bar by ensuring hospitals were doing so using a standardized file format.
    • Numerous reports from stakeholders criticized hospitals’ compliance along the way, with hospitals themselves often saying that the requirements were burdensome and often too vague.
    • On instruction from Congress, the GAO conducted a review of the requirements, the CMS’ enforcement and whether the agency’s policy was successfully serving patients, payers and researchers.
    • The GAO interviewed 16 stakeholder groups—representing those three groups—who described difficulties making effective comparisons and compiling the data for large-scale use. These hurdles were tied to inconsistent file formats, pricing complexities that came across poorly in the machine-readable format and what they perceived to be incomplete and inaccurate data sets.
    • “While the use of hospital price transparency data has been limited so far, many stakeholders we interviewed noted that they expect use to increase over time if the data usability challenges are overcome or addressed,” the GAO wrote in the report. “Further, some stakeholders also noted that it will take health plans and employers time to figure out how to effectively use the pricing data as part of their price negotiations and their efforts to develop networks of health care providers.”
  • The GAO also issued a healthcare capsule report on treatment for drug misuse.
  • Per an HHS press release,
    • “As part of the Biden-Harris administration’s efforts to ensure Americans access to affordable medicines and strengthen American medical supply chains, the Administration for Strategic Preparedness and Response (ASPR) today announced a $12.3 million agreement with California-based Amyris to expand U.S.-based manufacturing of key starting materials and active pharmaceutical ingredients needed to make essential medicines.” 
  • Tammy Flanagan, writing in Govexec, discusses end of year retirement planning for federal couples.
  • Per an OPM press release,
    • “The U.S. Office of Personnel Management (OPM) has authorized the use of an emergency leave transfer program (ELTP) for federal employees and their families adversely impacted by Tropical Cyclone, Tropical Storm, and Hurricane Helene.    
    • “After coordinating with federal agencies to assess the impact on employees by Tropical Cyclone, Tropical Storm, and Hurricane Helene and its aftermath, OPM, in consultation with the Office of Management and Budget (OMB), has determined that the establishment of an ELTP is warranted. The establishment of an ELTP permits employees in the executive and judicial branches, or agency leave banks established under 5 U.S.C. 6363 to donate unused leave for transfer to employees within their agency or at other agencies who are severely adversely affected or have family members who are severely adversely affected by a major disaster or emergency as declared by the President and who need additional time off from work without having to use their own paid leave. This ELTP will assist federal employees in the declared disaster areas in Alabama, Florida, Georgia, North Carolina, South Carolina, Tennessee, and Virginia. Furthermore, if President Biden approves other disaster declarations because of Helene, federal employees in those areas will also become eligible for ELTP donations.”    
  • Federal News Network tells us,
    • “The Merit Systems Protection Board has brought a historic backlog of federal employee adverse action cases down to nearly zero.
    • “By the end of September, MSPB reported that it had issued decisions on 94% of the thousands of federal employee appeal cases that had been sitting stagnant during the record five-year period without a quorum. Between 2017 and 2022, vacant board seats left the agency unable to issue case decisions, and thousands of federal employees without answers on their pending appeals.
    • “As an agency, MSPB aims to protect federal employees against prohibited personnel practices, like whistleblower retaliation, by adjudicating adverse action appeals from employees. But during more than five years without a quorum — which requires at least two of the three board seats to be occupied — MSPB amassed nearly 3,800 pending cases from federal employees looking to appeal a decision on an adverse action.
    • “The process of shrinking the significant case backlog has so far taken about 2.5 years for the current MSPB members. During fiscal 2025, the board expects to fully eliminate the remaining pending cases that built up during the lack of quorum. The agency will likely take the “inherited inventory” down to zero by the end of December, according to an MSPB spokesperson.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The U.S.’s largest maker of intravenous fluids will slash shipments to hospitals after Hurricane Helene took down one of its manufacturing plants in North Carolina. 
    • “Baxter sent letters to hospitals telling them that future shipments of IV fluids would be about 40% of what they normally receive after the storm flooded its facility in Marion, N.C., Dr. Paul Biddinger, chief preparedness and continuity officer at Mass General Brigham in Boston said during a conference call Thursday. 
    • “Mass General Brigham, a prestigious hospital system, said it is continuing to treat patients normally, but is conserving its fluid supplies. This includes switching to oral hydration—Gatorade or water—for patients who are healthy enough for it, and not discarding partially used IV fluid bags when patients are moved to a different part of the hospital, Biddinger said. The organization uses hundreds of thousands of liters of IV fluids each month, and a majority of patients admitted to a hospital receive fluids at some point, Biddinger said.
    • “Right now we’re continuing all of our clinical care as we normally do,” Biddinger said. “Our intent is to preserve clinical care in the face of this shortage as long as we possibly can.” 
  • Beckers Hospital Review identifies the 73 drugs and intravenous fluids made at the flooded Baxter facility.
  • The Washington Post explains “Why fears of human-to-human bird flu spread in Missouri are overblown. Hospital workers reported respiratory symptoms after encountering a Missouri patient with H5N1 who had not been exposed to farm animals. Officials say bird flu transmission is unlikely.”
  • The NIH Director, writing in her blog, tells us,
    • “In recent years, medical researchers have been looking for ways to use artificial intelligence (AI) technology for diagnosing cancer. So far, most AI models have been developed to perform specific tasks in cancer diagnosis, such as detecting cancer presence or predicting a tumor’s genetic profile in certain cancer types. But what if an AI system could be more flexible, like a large language model such as ChatGPT, performing a variety of diagnostic tasks across multiple cancer types?
    • “As reported in the journal Nature, researchers have developed an AI system that can perform a wide range of cancer evaluation tasks and outperforms current AI methods in tasks like cancer cell detection and tumor origin identification. It was tested on 19 cancer types, leading the researchers to refer to it as “ChatGPT-like” in its flexibility. According to the research team, whose work is supported in part by NIH, this is also the first AI model based on analyzing slide images to not only accurately predict if a cancer is likely to respond to treatment, but also to validate these predictions across multiple patient groups around the world.” * * *
    • “This is all good news, but there’s much more work ahead before an AI model like this could be used in the clinic. Next steps for the researchers include training the model on images of tissues from rare cancers, as well as from pre-cancerous and non-cancerous conditions. With continued development and validation, the researchers aim to enable the system to identify cancers most likely to benefit from targeted or experimental therapies in hopes of improving outcomes for more people with cancer in diverse clinical settings around the world.”
  • Healio informs us,
    • “The addition of HPV vaccination into routine postpartum care may increase vaccination rates, which can reduce patient costs, prevent HPV-related cancers and vaccinate vulnerable populations, researchers reported in Obstetrics & Gynecology. 
    • “The postpartum period has been identified as a missed opportunity for HPV vaccination counseling and administration,” Sara E. Brenner, MD, MPH, third-year resident in the department of gynecology and obstetrics at Emory University School of Medicine, and colleagues wrote. “Many vaccinations are already given routinely in the postpartum period such as the Tdap and the measles-mumps-rubella vaccines. These are often incorporated into perinatal workflows so that patients are routinely educated on their options for vaccination during their prenatal visits and postpartum patients can receive them before leaving the hospital.”
  • The American Hospital Association News informs us about “refreshed webpages dedicated to maternal and child health. The redesigned platform offers three distinct subpages focused on Better Health for Mothers and Babies, child and adolescent health, and advocacy and policy. Hospitals and health systems are encouraged to explore the tools and resources, such as case studies, podcasts, infographics and action plans to drive their own improvement in maternal and child health.”
  • Per STAT News,
    • “Apple Watch may help keep people with Parkinson’s disease out of the hospital. That’s according to early data from a Kaiser Permanente pilot program.
    • “Since late 2023, Kaiser Permanente has been giving some of its Parkinson’s patients in California an Apple Watch app called StrivePD, developed by Rune Labs. The app uses the onboard sensors in the device to track tremors associated with the disease; dyskinesia, a side effect of medication; activity; sleep; and falls. Using Rune’s software, people can also track medication intake and other data.” * * *
    • “Kaiser and Rune presented data from 138 patients enrolled in the program at the International Congress of Parkinson’s Disease and Movement Disorders in late September. In a limited run, the program reduced patient visits to the emergency department by 42% and reduced visits to movement disorder specialists by 18%. Three-quarters of people in the program reported that they found StrivePD helpful for staying on top of medications.
    • “It’s important to note that the data is only a snapshot from the first 100 days that people are in the program. It is not a randomized control that researchers would want to see to establish the benefits of a treatment program. And the data has not been published in a peer-reviewed publication.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports this evening,
    • “U.S. dockworkers agreed to return to work after port operators sweetened their contract offer, ending a three-day strike that threatened to disrupt the American economy.
    • “The breakthrough Thursday came after port employers offered a 62% increase in wages over six years, according to people familiar with the matter.
    • “The agreement ends a strike that had closed container ports from Maine to Texas and threatened to disrupt everything from the supply of bananas in supermarkets to the flow of cars through America’s factories.”
  • Per Fierce Healthcare,
    • “Another significant legal headache related to star ratings is on the table of the federal government just days before open enrollment begins.
    • “UnitedHealthcare companies in various states are suing the Centers for Medicare & Medicaid Services (CMS) for decreasing the insurer’s star ratings unfairly. They are looking for an injunction and corrected ratings before Oct. 15.
    • “The plaintiffs allege one metric, call center customer service performance, was downgraded based on an “arbitrary and capricious assessment” of one phone call [by a CMS test caller] that lasted eight minutes. It caused the insurer to earn a four-star rating on the call center measure instead of a five-star rating.”
    • UnitedHealthcare said the star ratings downgrade would “misinform millions of current and potential customers” from choosing their plans, the insurer said in the lawsuit.
  • Per BioPharma Dive,
    • “Eli Lilly on Wednesday announced plans to spend $4.5 billion on a new facility that will use advancements in technology for research and manufacturing.
    • “Dubbed the Lilly Medicine Foundry, the new site will be located in the “LEAP Research and Innovation District” in Lebanon, Indiana. The latest infusion of cash brings Lilly’s investment in the LEAP district to more than $13 billion.
    • “The facility will allow Lilly to produce medicines for clinical trials while also researching new methods of manufacturing, the company said. Technologies developed at the foundry can then be deployed at other production sites around the world.”

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.

Thursday Miscellany

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–

From Washington, DC

  • Per a White House press release,
    • “On Thursday, September 26, 2024, the President signed into law:
    • “H.R. 9747, the ”Continuing Appropriations and Extensions Act, 2025,” which provides fiscal year 2025 appropriations to Federal agencies through December 20, 2024, for continuing projects and activities of the Federal Government.”
  • Bye, bye Congress. See you in November.
  • MedTech Dive adds,
    • “Congress has again deferred Medicare reimbursement cuts of up to 15% for clinical laboratory tests with the passage Wednesday of a short-term government funding bill.
    • “The appropriations bill pushes back by one year the implementation of Medicare payment rates scheduled to take effect in January for about 800 lab services.
    • “We are pleased that Congress has delayed pending reductions, recognizing the harm repeated Medicare reductions would have on the nation’s health care system that relies on clinical laboratory testing every day to inform patient care,” Susan Van Meter, president of the American Clinical Laboratory Association, said in a Wednesday statement.”
  • Here are links on yesterday’s OPM’s 2025 FEHBP/FEDVIP premium announcement from Govexec, Fedweek and FedSmith. Govexec also reports, “Biden administration officials said that two nationwide insurers in the federal government’s employer-sponsored health care program [Blue Cross FEP and GEHA] will offer $25,000 worth of in vitro fertilization and other fertility treatments.
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) through the Advanced Research Projects Agency for Health (ARPA-H) announced funding for the Transforming Antibiotic R&D with Generative AI to stop Emerging Threats (TARGET) project, which will use AI to speed the discovery and development of new classes of antibiotics. This program is another action to support the United States’ longstanding commitment to combating antimicrobial resistance (AMR), from groundbreaking innovation to international collaboration. The U.S. is a global leader in the fight against AMR and has a demonstrated track record of progress in protecting people, animals, and the environment from the threat of AMR domestically and globally.”

From the public health and medical research front,

  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration approved [Bristol, Myers, Squibb’s] Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.
    • “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” said Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
  • BioPharma Dive offers an excellent explanation of the various factors affecting sales of this drug.
  • KFF Health News points out that “Deadly High Blood Pressure During Pregnancy Is on the Rise.”
  • The Washington Post reports,
    • “A New York resident has died amid a nationwide listeria outbreak tied to Boar’s Head deli meat, the Centers for Disease Control and Prevention announced Wednesday, bringing the death toll to 10 in the largest outbreak of the foodborne illness since 2011.
    • “The agency also reported two new hospitalizations associated with the outbreak. In total, 59 people have been hospitalized in 19 states since late May.
    • “Deaths have occurred in Illinois, New Jersey, New York, Virginia, Florida, Tennessee, New Mexico and South Carolina. In its latest update, the CDC noted that illnesses have started to decrease. The number of sick people is probably higher than the official case count, the agency said, since those who do not seek medical care are not tested for listeria.
    • “Boar’s Head identified the production process for liverwurst at its plant in Jarratt, Va., as the culprit for contaminating the meat. This month, the company announced it would indefinitely close the southern Virginia plant and permanently discontinue liverwurst.”
  • The NIH Director writes in her blog,
    • “Genetic mutations affect nearly all human diseases. Some genetic disorders such as cystic fibrosis are caused by mutations in a single gene that a person inherits from their parents. Other diseases can be caused by changes in multiple genes or from a combination of gene mutations and environmental factors. We still have a lot to learn about the complex ways that variations in our genes affect health and disease.
    • “Researchers investigating genetic disorders have primarily studied mutations that cause our cells to alter the makeup of proteins, like the most common mutations that cause cystic fibrosis. Less research has been done on alterations called synonymous mutations, which have been called “silent” because they don’t alter the makeup of proteins, leading scientists to long assume that these kinds of mutations don’t produce any noticeable differences in our biology or health. However, recent research has shown that synonymous mutations can lead to significant changes in a cell’s ability to survive and grow. A new NIH-supported study reported in Proceedings of the National Academy of Sciences sheds additional light on the impact of synonymous mutations and their effect on the way proteins are made.” * * *
    • “The researchers behind this study, at the University of Notre Dame in Notre Dame, IN, wanted to understand how synonymous mutations may affect how much protein is made and whether proteins are folded correctly in cells. Misfolded proteins are known to play roles in numerous diseases, including cystic fibrosis, Alzheimer’s disease, and some cancers. The study team, led by Patricia L. Clark, who received an NIH Director’s Pioneer Award in 2021 for this work, has shown that synonymous mutations in a particular gene in Escherichia coli (E. coli) bacteria can alter how the encoded protein folds as it is being made, by altering the rate at which cells produce each copy of the protein. The new research goes a step further and shows that silent mutations in one gene can affect the amount of protein produced from a separate, neighboring gene.” * * *
    • “This discovery in E. coli may have important implications for understanding the bacteria’s biology and evolution. Clark’s team continues to study this system to learn more. Their findings may also prove to have broader implications for biology, including for some genetic disorders. It’s an area that warrants more study and attention, to better understand the roles that synonymous mutations may be playing in genes and their effects on human health.”
  • Per an NIH press release,
    • “Scientists at the National Institutes of Health (NIH) and their colleagues have identified a gene responsible for some inherited retinal diseases (IRDs), which are a group of disorders that damage the eye’s light-sensing retina and threatens vision. Though IRDs affect more than 2 million people worldwide, each individual disease is rare, complicating efforts to identify enough people to study and conduct clinical trials to develop treatment. The study’s findings published today in JAMA Ophthalmology.
    • “In a small study of six unrelated participants, researchers linked the gene UBAP1L to different forms of retinal dystrophies, with issues affecting the macula, the part of the eye used for central vision such as for reading (maculopathy), issues affecting the cone cells that enable color vision (cone dystrophy) or a disorder that also affects the rod cells that enable night vision (cone-rod dystrophy). The patients had symptoms of retinal dystrophy starting in early adulthood, progressing to severe vision loss by late adulthood.
    • “The patients in this study showed symptoms and features similar to other IRDs, but the cause of their condition was uncertain,” said Bin Guan, Ph.D., chief of the Ophthalmic Genomics Laboratory at NIH’s National Eye Institute (NEI) and a senior author of the report. “Now that we’ve identified the causative gene, we can study how the gene defect causes disease and, hopefully, develop treatment.”
    • “Identifying the UBAP1L gene’s involvement adds to the list of more than 280 genes responsible for this heterogeneous disease.”
  • The U.S. Preventive Services Task Force posted a “Final Research Plan for Enhanced Risk Assessment for Cardiovascular Disease: Coronary Artery Calcium Scoring.”

From the U.S. healthcare business front,

  • The FEHBlog was surprised to read in Beckers Hospital Review that
    • Johnson & Johnson will discontinue upfront 340B drug rebates for certain hospitals, raising concerns among healthcare providers and advocacy groups. The proposed policy, set to take effect Oct. 15, would prevent certain hospitals from accessing 340B discounts for Stelara, used to treat plaque psoriasis, psoriatic arthritis and other conditions; and Xarelto, a blood thinner.
  • Per Fierce Healthcare,
    • “While consumers give telehealth high marks for convenience, overall experience is fairly mixed, according to a new report.
    • “J.D. Power released its annual Telehealth Satisfaction Study on Thursday, and found patients overall gave a score of 730 out of 1,000 for direct-to-consumer telehealth platforms. Payer-provided telehealth earned a lower score of 708, which suggests patients encounter differences in quality and ease of access between providers.
    • “The study also found the highest satisfaction scores for people enrolled in Medicaid, those living in urban areas, millennials and Gen Zers. The lowest scores were among people enrolled in Medicare or commercial coverage, those living in suburban regions and members of the Boomer generation or older.”
  • McKinsey and Company explore “Reimagining healthcare industry service operations in the age of AI.”
  • KFF offers “A Snapshot of Sources of Coverage Among Medicare Beneficiaries” and tells us “Nearly 7 in 10 Medicare Beneficiaries Did Not Compare Plans During Medicare’s Open Enrollment Period.”

Midweek update

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • NBC News informs us,
    • “House Republicans on Wednesday defeated their own plan to avert a government shutdown at the end of the month, with the party divided over the length of a short-term funding bill and what, if anything, should be attached to it.
    • “It was an embarrassing blow to Speaker Mike Johnson, R-La., who had yanked the same funding package off the floor last week amid growing GOP defections, only to watch it collapse on Wednesday in a vote that seemed doomed from the start.
    • “The vote was 202-220 with two members voting present. In all, fourteen Republicans voted against the package and three Democrats voted for it.
    • “Thirteen days before money runs out for the federal government, there is still no bipartisan plan to stave off a shutdown. While the GOP-led House could try again, the focus now likely shifts to the Senate, where leaders in both parties agree a shutdown would be disastrous weeks before the election.”
  • Govexec adds,
    • “Legislation to cover a $3 billion shortfall in veterans’ benefits through the end of the month passed the House Tuesday, three days before benefits could be disrupted.  
    • “Lawmakers passed the Veterans Benefits Continuity and Accountability Supplemental Appropriations Act by voice vote Tuesday evening, sending it to the Senate ahead of a Friday deadline to ensure the Veterans Affairs Department can process benefit payments for 7 million veterans. * * *
    • “Senate Veterans’ Affairs Committee Chairman Jon Tester, D-Mont., said in a statement Tuesday that it was critical that the Senate move with haste to pass the legislation.”
  • STAT News reports,
    • “A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities, and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives.
    • “Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth. The two-year telehealth extension unanimously passed on Wednesday by the House Energy & Commerce Committee is very similar to bills advanced in May by Commerce’s health subcommittee and the House Ways & Means Committee. 
    • “The two bills set up the House position heading into negotiations with the Senate on extending the telehealth policies, which expire at the end of December.” 
  • Per Federal News Network,
    • “House Democrats are pushing harder to try to help federal employees more easily access IVF treatments. A new bill, called the Right to IVF Act, rolls together four previous bills all aiming to broaden fertility coverage nationwide. Part of the legislation would require carriers in the Federal Employees Health Benefits Program to increase their coverage of IVF for FEHB enrollees. The Democrats who introduced the bill are calling for a House floor vote, but so far, the legislation has no Republican co-sponsors.(Right to IVF Act – Reps. Gerry Connolly (D-Va.), Susan Wild (D-Pa.), Rick Larsen (D-Wash.) and Rosa DeLauro (D-Conn.))”
  • and
    • “Federal benefits for health and retirement are a major recruitment and retention influence for employees, especially for early-career talent.
    • “Women as well as individuals in younger generations ranked the importance of federal benefits more highly than older or male employees, according to the results of the 2023 Federal Employee Benefits Survey (FEBS) from the Office of Personnel Management, obtained exclusively by Federal News Network.
    • “The benefits stemming from the Federal Employees Health Benefits (FEHB) program and the paid parental leave program are particularly important to younger generations of employees, OPM’s survey showed. Specifically, 94% of millennial and Gen Z respondents said the FEHB was either “important” or “extremely important” to them, compared with 84% of baby boomers and older generations who gave the same response.
    • “It is clear that these major benefit programs have an impact on both recruiting and retaining talent in the federal government, making it critical to continuously improve these benefits to meet employee needs,” OPM wrote in the survey results.”
  • A commentator writing in Real Clear Health commends the FEHB Program for being a catalyst for change in women’s health care and suggests three improvements:
    • Provide solutions for perimenopause and menopause
    • Provide a safety net for caregivers, and
    • Provide enhanced family planning and maternal care.
  • Mercer Consulting offers FAQs on the Supreme Court’s recent Loper Bright decision.
    • “The US Supreme Court overturned a 40-year-old principle of administrative law known as the Chevron deference doctrine (Loper Bright Enterprises et al. v. Raimondo, Secretary of Commerce, et al.). That doctrine required courts to defer to administrative agencies’ reasonable interpretation of a federal law that is silent or ambiguous. Now, federal courts must exercise independent judgment when determining the best interpretation of a statute and cannot simply defer to agency interpretations, even when they are reasonable. This will likely increase courts’ scrutiny of federal agency regulations that are subject to legal challenges. These FAQs provide high-level information about the case and its potential impact on employee benefit plans and their sponsors. Also, this Mercer US Health News 15-minute video highlights the practical implications of this opinion on employer-sponsored health plans.”

From the public health and medical research front,

  • MedPage Today lets us know,
    • “The new COVID-19 variant XEC may overtake others in circulation to become dominant in the coming months, experts said but will not prompt a meaningful change in symptoms or vaccine response.” * * *
    • “XEC represents a fairly minor evolution relative to the SARS-CoV-2 diversity currently in circulation, and is not a highly derived novel variant such as those that were granted Greek letters,” like Alpha, Delta, and Omicron, Francois Balloux, PhD, a computational biologist at University College London and director of the UCL Genetics Institute, said in a Science Media Centre statement.
    • “Experts noted that while XEC may have a small advantage in transmission, available vaccines are still likely to provide protection from serious illness.
    • “XEC is a “recombinant variant of some of the other Omicron lineages that have been around for a while, and it does appear to be more immune evasive, giving it a transmissibility advantage in the population with the immunity that it has,” Amesh Adalja, MD, of the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today. “But it doesn’t really change anything, just like the last variant didn’t change anything, or the one before that, one before that, or the one before that.”
  • NBC New points out,
    • “Black women are more likely than white women to die from even the most treatable types of breast cancer, a study published Tuesday in the Journal of Clinical Oncology found.
    • “The findings, experts say, underscore that it’s racial disparities, not biology, driving the biggest differences in death rates between Black and white women. While Black women and white women are diagnosed with breast cancer at similar rates, Black women are 40% more likely to die from the disease.” * * *
    • “If you look at breast cancer data from 40 years ago, there really weren’t differences in mortality for breast cancer between Black and white women. We weren’t very good at treating and diagnosing it. But as we’ve gotten better, the gap between white and Black women has grown,” [lead author Dr. Erica] Warner said. “That is problematic, but that also tells us we have our foot on the pedal for these differences. If we can create them, we can eliminate them.” 
  • STAT News reports,
    • “A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up.
    • “On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks. 
    • “Notably, only two of 71 patients who received a high dose of therapy have shown signs of ocular inflammation, 4D said. In 2021, another leading contender, Adverum, was set back after a patient with a related disease went blind in one eye. 
    • “I think it’s very positive and there’s a good chance they’ll be able to move toward approval,” said Ron Crystal, chair of genetic medicine at Weill Cornell Medical Hospital, who has served as a scientific adviser to and has stock in Adverum.”
  • The New York Times notes,
    • “Adults under age 50 have been developing breast cancer and colorectal cancer at increasingly higher rates over the last few decades, and alcohol use may be one factor driving the trend, according to a scientific report published on Wednesday.
    • “The report, by the American Association for Cancer Research, highlights scientific breakthroughs that have led to new anticancer drugs and improved overall survival.
    • “But the authors also described a troubling pattern: Even as cancer death rates have declined, the overall incidence of several cancers has been rising inexplicably, with an especially alarming increase among younger adults in cancers of the gastrointestinal system, like colorectal cancer.
    • “The report estimates that 40 percent of all cancer cases are associated with modifiable risk factors. It recommends reducing alcohol consumption, along with making lifestyle changes such as avoiding tobacco, maintaining a healthy diet and weight, exercising, avoiding ultraviolet radiation and minimizing exposure to pollutants.”
  • Per NIH press releases,
    • “Results from a large study supported by the National Institutes of Health show that protein analyses taken during the first trimester of pregnancy did not improve predictions for identifying people at risk for experiencing conditions related to having high blood pressure during pregnancy. Since there is an urgent need to better predict people at risk for developing conditions related to having high blood pressure during pregnancy, also called hypertensive disorders of pregnancy, researchers have been studying if proteins taken from blood or urine samples could provide this insight. This study provides the largest data to date based on using protein analyses from blood samples during early pregnancy.”
  • and
    • “Researchers at the National Institutes of Health (NIH) and their collaborators have identified a protein, known as RNF114, that reverses cataracts, a clouding of the eye’s lens that occurs commonly in people as they age. The study, which was conducted in the 13-lined ground squirrel and rats, may represent a possible surgery-free strategy for managing cataracts, a common cause of vision loss.  The study published in the Journal of Clinical Investigation.
    • “Scientists have long searched for an alternative to cataract surgery, which is effective, but not without risk. Lack of access to cataract surgery is a barrier to care in some parts of the world, causing untreated cataracts to be a leading cause of blindness worldwide,” said Xingchao Shentu, M.D., a cataract surgeon and the co-lead investigator from Zhejiang University, China.” * * *
    • “According to the scientific team, these findings are proof-of-principle that it is possible to induce cataract clearance in animals. In future studies, the process will need to be fine-tuned so scientists can stimulate specific protein degradation to see how to precisely regulate protein stability and turnover. This mechanism is also an important factor in many neurodegenerative diseases, they said.”
  • and
    • “A clinical trial supported by the National Institutes of Health (NIH) was stopped early after researchers found sufficient evidence that a drug used to treat bone marrow cancer and Kaposi sarcoma is safe and effective in treating hereditary hemorrhagic telangiectasia (HHT), a rare bleeding disorder that affects 1 in 5,000 people worldwide. The trial results, which are published in the New England Journal of Medicine, detail how patients with HHT given the drug, called pomalidomide, experienced a significant reduction in the severity of nosebleeds, needed fewer of the blood transfusions and iron infusions that HHT often demands, and showed improved quality of life.
    • “Finding a therapeutic agent that works in a rare disorder is highly uncommon, so this is a real success story,” said Andrei Kindzelski, M.D., Ph.D., of NIH’s National Heart, Lung, and Blood Institute. “Before our trial, there was no reliable therapeutic to treat people with HHT. This discovery will give people who suffer with this disease a positive outlook and better quality of life.”

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “St.-Louis-based Ascension reported a $79 million operating loss (-0.3% margin) for the 10 months ending April 30, a substantial improvement on the $1.2 billion operating loss in the previous 10-month period. 
    • “The results include $402 million in one-time, non-cash write-downs and non-recurring losses.
    • “In May and June 2024, operations were hampered by the May ransomware attack, resulting in reduced revenues from the associated business interruption along with costs incurred to address the issues and other business-related expenses.
    • “Despite this incident, Ascension drove a $1.2 billion operational improvement year over year for the 10 months ending April 30. The 136-hospital system’s economic improvement plans focused on volume growth, rates and pricing, and cost levers. 
    • “The results are a notable improvement on the $3 billion operating loss (-5.5% margin) reported in fiscal year 2023. Including the cyberattack, Ascension reported a $1.8 billion (-4.9% margin) loss in FY 2024. 
    • “Ascension is also reorganizing its portfolio with several transactions in multiple markets.”
  • Healthcare Dive tells us,
    • “Community Health Systems’ Northwest Urgent Care has signed a definitive agreement to purchase 10 Arizona urgent care centers from Carbon Health for an undisclosed price, according to a press release this week.
    • “The acquisition, which is expected to close in the fourth quarter, will grow CHS’ integrated health network to more than 80 care sites in the Tucson, Arizona region, according to CHS.
    • “The acquisition is a reversal from CHS’ recent string of hospital divestitures, which have been integral to helping the operator deleverage its portfolio.”
  • Per BioPharma Dive,
    • “Organon has agreed to buy Roivant’s dermatology subsidiary Dermavant for $175 million upfront plus more than $1 billion in potential additional payments if certain milestones are hit.
    • “With the acquisition, Organon will gain Dermavant’s cream called Vtama, which was approved in 2022 to treat plaque psoriasis. The medicine is also awaiting action from the Food and Drug Administration that could expand its use to include atopic dermatitis, commonly known as eczema.
    • “Approval in eczema, expected in the fourth quarter, would trigger a $75 million payment, Organon said Wednesday. The deal also includes $950 million in potential commercial milestone payments as well as tiered royalties on net sales to Dermavant shareholders. Roivant owns the majority of Dermavant.”
  • Fierce Healthcare points out,
    • “If a patient receives a continuous glucose monitor device through their medical benefit, they may be more adherent and may have lower costs, according to a new analysis.
    • “Researchers at CCS, which offers clinical services and home delivery for medical supplies for people with chronic conditions, published the peer-reviewed study this week in the Journal of Medical Internet Research Diabetes (JMIR) and found that patients who secured the monitors through their medical coverage had 23% higher rates of adherence.
    • “The study included data on 2,356 people, with 1,178 in the pharmacy benefit group and 1,178 in the durable medical equipment cohort. In addition to greater adherence, the study found that people who received the devices through their medical benefit had 35% lower average annual total costs of care.
    • “And, for patients who were not adherent to their devices, there was a higher rate of reinitiation (22%) for those in the medical benefit compared to those who received the glucose monitors through their pharmacy benefit (11%).”
  • Per MedTech Dive,
    • “Zimmer Biomet will phase out sales of its CPT Hip System by December due to concerns about the risk of thigh bone fractures, the Food and Drug Administration said in a Tuesday notice. 
    • “Despite plans to pull the device, the FDA said it is still concerned about the hip system being implanted in new patients, and it is “working with the manufacturer to address these concerns.” 
    • “Earlier this month, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) flagged a higher risk of thigh bone fracture after surgery with the CPT Hip System, compared with similar hip replacement devices. While the analysis is currently unpublished, the British Hip Society and the British Orthopaedic Association advised against using the implant for elective surgery unless in exceptional circumstances.”

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association (AHA) News tells us,
    • “Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Bob Casey, D-Pa., Sept. 11 introduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with building on its current efforts addressing sepsis care. New efforts would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, including the Centers for Medicare & Medicaid Services on sepsis quality measures, and the development and implementation of a sepsis outcome measure. The bill also includes a voluntary recognition program for hospitals which maintain effective sepsis programs or improve their programs over time.”  
  • The University of Minnesota’s CIDRAP lets us know,
    • “A National Academies of Sciences, Engineering and Medicine report recommends five actions to transition the National Wastewater Surveillance System (NWSS)—developed as a response to the COVID-19 pandemic—to a forward-looking version for both endemic and emerging pathogens.
    • “The paper, released yesterday, is the second and final report by the Academies’ Committee on Community Wastewater-Based Infectious Disease Surveillance done at the behest of the Centers for Disease Control and Prevention (CDC).
    • “The CDC launched the NWSS with the US Department of Health and Human Services to centralize the detection and quantification of pathogen biomarkers that people shed into the sewer system.
    • “Whereas clinical laboratory testing tracks individual cases of infection, sampling and analysis at the wastewater treatment plant level (termed community-level wastewater surveillance) provide aggregate data from the homes, businesses, and other institutions that share a common sewer system,” the committee wrote.”
  • CMS has launched a public facing website and posted a consumer fact sheet about the Medicare Prescription Payment Plan which will take effect January 1, 2025.
  • Healthline offers a projection of 2025 IRMAA brackets applicable to Medicare Parts B and D coverage for higher income beneficiaries.
  • Tammy Flanagan, writing in Govexec, offers thirteen things to know about long-term care planning.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention posted their weekly summary concerning respiratory illnesses in the U.S. today.
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • “COVID-19
      • “COVID-19 activity remains elevated nationally, but there are continued signs of decline in many areas. 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. 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.”
  • Ruh roh. The New York Times reports,
    • “Someone who lived with a Missouri resident infected with bird flu also became ill on the same day, the Centers for Disease Control and Prevention reported on Friday.
    • “The disclosure raises the possibility that the virus, H5N1, spread from one person to another, experts said, in what would be the first known instance in the United States.
    • “On Friday night, C.D.C. officials said that there was “no epidemiological evidence at this time to support person-to-person transmission of H5N1,” but that additional research was needed.
    • “The coincidental timing of the illnesses, especially outside flu season, concerned independent experts. H5N1 has been known to spread between close contacts, including those living in the same household.
    • “And neither the initial patient nor the household contact had any known exposure to the virus via animals or raw milk.
    • “Neither patient has been identified, and details are scant. The household contact was not tested, so officials cannot be sure that the individual actually was infected with the bird flu virus.”
  • More ruh roh. Health Day points out,
    • “U.S. obesity rates keep rising, with 1 in every 5 people in every state reported to be obese in 2023
    • “In 23 states, 35% or more of the population is now obese
    • “Tackling unhealthy weight gain as early as childhood may be key to turning these numbers around.”
  • The NIH Director cheers us up by writing in her blog,
    • In Parkinson’s disease, neurons in parts of the brain gradually weaken and die, leading people to experience worsening problems with movement and other symptoms. While the causes of this disease aren’t fully known, studies have suggested the Parkinson’s brain lacks fuel to power dopamine-producing neurons that are essential for movement. When too many of those neurons are lost, Parkinson’s disease symptoms appear. But what if there was a way to boost energy levels in the brain and stop the neurodegenerative process in its tracks?
    • While the findings are preliminary, an NIH-supported study reported in Science Advances takes an encouraging step toward this goal. The key element, according to the new work, is an energy-producing enzyme known as phosphoglycerate kinase (PGK1). In fact, these latest preclinical findings in models of the disease suggest that boosting this enzyme in the brain even slightly may be enough to restore energy and afford some protection against Parkinson’s disease.
    • The team, led by Timothy Ryan and Alexandros Kokotos , Weill Cornell Medicine, New York City, was inspired by recent discoveries suggesting an unexpectedly important role for PGK1 in protecting the normal function of neurons. They knew PGK1 plays an essential role in the pathway through which cells use glucose to generate and store energy in the form of adenosine 5′-triphosphate (ATP) molecules. The surprise came when studies showed the drug terazosin, which is used to treat high blood pressure and enlarged prostate, has an unexpected side effect: it enhances PGK1 activity, although perhaps weakly. * * *
    • “For the approximately one million Americans with Parkinson’s disease today, current treatments help to relieve symptoms but don’t stop the disease from progressing. These new findings raise the possibility that terazosin or drugs that enhance PGK1 activity even more may fuel the brain, helping to protect essential dopamine-producing neurons to treat or even prevent Parkinson’s disease, as well as other neurodegenerative conditions where PGK1 may play a role.”
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has established a pandemic preparedness research network to conduct research on high-priority pathogens most likely to threaten human health with the goal of developing effective vaccines and monoclonal antibodies. Currently, many of the diseases caused by these pathogens have no available vaccines or therapeutics, and investing in this research is key to preparing for potential public health crises—both in the United States and around the world. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) expects to commit approximately $100 million per year to fund the program, pending the availability of funds.
    • “The Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness network—called ReVAMPP—will focus its research efforts on “prototype pathogens,” representative pathogens from virus families known to infect humans, and high-priority pathogens that have the potential to cause deadly diseases. By studying specific prototype pathogens, scientists will build a knowledge base that could be applied to other related viruses. For example, NIAID’s earlier work on the Middle East respiratory syndrome coronavirus (MERS-CoV) played a crucial role in understanding and developing safe and effective treatments and vaccines for SARS-CoV-2, the virus that caused the COVID-19 pandemic. The ReVAMPP network will study viruses from virus families that have caused human disease for millennia—many of which have the potential to become pandemic threats in the future.
    • “In the wake of the COVID-19 pandemic and ongoing outbreaks of emerging infectious diseases, the need for robust pandemic preparedness is evident,” said NIAID Director Jeanne M. Marrazzo, M.D., M.P.H. “The ReVAMPP network will enable researchers to fill key knowledge gaps and identify strategies to develop safe and effective medical countermeasures for targeted virus families before the need becomes critical.”
  • STAT News reports,
    • “A new drug — approved by regulators last month — has shown it can delay tumor progression, meaning patients could get more years to work and travel and be with their families before subjecting themselves to the rigors of the more pernicious treatments, which can lead to a range of health and cognitive problems. It is one of the first major brain tumor breakthroughs in decades.
    • “It gives you more time to do the things you love to do and lets you live a more normal life,” said [a patient], who enrolled in the trial that led to the approval of the drug, called Voranigo and developed by the privately held French firm Servier.
    • “Taken as a daily pill, Voranigo, or vorasidenib, is a signal to researchers and other pharmaceutical companies that success in this field is possible. It’s also the first targeted therapy designed specifically for this brain cancer, homing in on a genetic mutation that drives tumor formation and bringing the type of the success seen in lung and breast cancers to among the most difficult-to-treat tumors. 
    • “The drug, which has a list price of nearly $480,000 a year, is approved for patients with specific types of brain tumors — gliomas and astrocytomas — that are categorized as grade 2, a few thousand of which are diagnosed every year in the U.S. (Brain tumors are graded on a scale of 1 to 4, with higher grades indicating tumors that are more aggressive.) It’s also only meant for people who have particular mutations in one of two related genes, known as IDH1 or IDH2, who account for the large majority of low-grade glioma patients. Now, researchers are starting to test it in combination with other treatments in more advanced brain cancers. 
    • “I was in the field for 38 years, and when you can count the number of approved drugs on one hand, you know you’ve got a difficult disease to treat,” said Mark Gilbert, who recently retired as chief of the National Cancer Institute’s neuro-oncology branch.” 

From the U.S. healthcare business front,

  • The New York Times reports,
    • Boar’s Head announced on Friday that it would indefinitely shut down the troubled Virginia deli meat plant that it acknowledged had caused a deadly listeria outbreak, killing nine people and sickening dozens more in 18 states.
    • The company also said it had identified liverwurst processing as the source of contamination and would permanently discontinue the product.
    • “Given the seriousness of the outbreak, and the fact that it originated at Jarratt, we have made the difficult decision to indefinitely close this location,” the company said in a statement posted on its website Friday. The shutdown affects about 500 workers in Jarratt, Va., a small rural town whose economic livelihood largely depended on the plant’s business.
  • Per Fierce Healthcare,
    • “Employers are bracing for a third straight year with health benefit costs increasing more than 5%, according to a new report from Mercer.
    • “The organization released preliminary findings from its annual National Survey of Employer-Sponsored Health Plans and found that the total health benefit cost for individual employees is expected to increase by 5.8% in 2025. This accounts for any cost-reduction initiatives that employers may take on.
    • “The survey, based on responses from 1,800 employers across the country, estimates that with no cost-reduction efforts, expenses would increase by 7% per worker.”
  • and
    • “Elevance Health has entered into a deal to acquire Indiana University Health Plans, the company’s Anthem Blue Cross unit announced this week.
    • “Should the deal close, IU Health Plans will operate as part of Anthem in the Hoosier State, according to the press release. Financial terms of the sale were not disclosed.
    • “IU Health Plans provides Medicare Advantage plans to 19,000 people across 36 counties and has a 4.5-star rating from the Centers for Medicare & Medicaid Services. It also has 12,000 fully insured commercial plan members, according to the release.” * * *
    • “The parties expect the deal to close at the end of 2024.”
  • Per Beckers Hospital Review,
    • “Oakland, Calif.-based Kaiser Permanente received approval from the San Jose (Calif.) planning commission during a Sept. 11 meeting to move forward with plans to demolish its existing San Jose Medical Center and build a new hospital.
    • “Kaiser Permanente San Jose is excited about this new facility, which will provide greater access to high-quality care and medical services to our members and patients in the greater San Jose community,” a spokesperson for Kaiser shared with Becker’s in a Sept. 12 statement. 
    • “The project, which the health system shared initial plans for in February, would demolish the current 250,000-square-foot hospital and develop a new 685,000-square-foot hospital, central utility plant and a five-level parking garage, resulting in the addition of around 800 new employees.
    • “It would also increase bed count from 247 to 303, according to project highlights during the meeting.” 
  • Per Healthcare Dive,
    • “Steward Health Care exited a federal bankruptcy court hearing on Wednesday absolved of billions of dollars in outstanding lease agreements and with a plan to keep the majority of its remaining hospitals open.
    • “Under the deal, Steward’s landlord, Medical Properties Trust, will forgive approximately $7.5 billion in outstanding obligations and allow Steward to receive $395 million in proceeds from a recent hospital sale in Florida in order to pay its lenders and unsecured creditors, according to testimony from the health system’s chief restructuring advisor, John Castellano.
    • “In exchange, Steward will waive its rights to pursue lawsuits against the real estate investment trust.”
  • Per Fierce Pharma,
    • “When Roche’s Genentech gained approval for Ocrevus in 2017, the first-in-class infused drug quickly became the best-selling treatment in a crowded multiple sclerosis (MS) market. Three years later, Novartis’ next-in-class Kesimpta stole some of Ocrevus’ thunder, offering a convenience edge with its once-monthly, at-home prefilled injection. 
    • “Now, Genentech has responded with a new formulation as the FDA has endorsed a subcutaneous version of Ocrevus. While it can’t match the at-home convenience of Kesimpta, subcutaneous Ocrevus Zunovo, with its twice-a-year, under-the-skin dosing regimen, provides an attractive option.
    • “This is something than can be provided in clinics and doesn’t require people to go to an infusion center,” David Jones, Genentech’s medical director for MS, said in an interview. “This will expand access to individuals who may not be able to access Ocrevus now, especially for reasons like geography or rural setting, individuals that might have challenges with their healthcare provider.”
    • “Ocrevus Zunovo can be injected in 10 minutes, compared to the two-plus hours needed for an infusion of the drug. For patients who experience side effects, the intravenous infusion can take up to four hours.” 
  • and
    • “It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company’s initial launch plans last year.
    • “The agency was originally slated to issue its verdict on Tecentriq in its under-the-skin formulation last September but the drug’s manufacturing processes needed updating, Roche’s delivery technology partner Halozyme Therapeutics said in a filing at the time. The tweaks, which a Roche spokesperson said were made in response to the FDA’s evolving requirements, were expected to wrap up in 2023 to support a 2024 launch. The world-first approval for the formulation came in the U.K. last year. 
    • “Now, the therapy has been cleared for use in the U.S. in all of the Tecentriq adult formulation’s indications, including types of lung, liver, skin and soft tissue cancers. The new version uses Halozyme’s Enhanze drug delivery tech to subcutaneously inject the product over seven minutes, compared to the 30 to 60 minutes needed for an IV infusion.
    • “By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Roche’s chief medical officer and head of global product development Levi Garraway, M.D., Ph.D., said in a press release.”

Midweek Update

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

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson’s plan to tie a six-month spending extension to a voting restriction bill pushed by former President Donald Trump was stymied Wednesday as the Louisiana Republican was forced to pull the package from the floor schedule.
    • “Johnson announced his decision midday in the face of certain defeat instead of pushing forward with the planned vote around 4:30 p.m. He said GOP leaders would continue to work on the package to try to shore up votes over the weekend, in hopes of bringing it back to the floor as soon as next week.
    • “The whip is going to do the hard work and build consensus. We’re going to work through the weekend on that,” Johnson told reporters shortly before the House convened at noon. “No vote today because we’re in the consensus-building business here in Congress. With small majorities, that’s what you do. …We’re having thoughtful conversations, family conversations, within the Republican conference, and I believe we’ll get there.”
    • “Despite vowing to push forward with the current text, the speaker and his allies will likely need to pivot to a new strategy to avoid a partial government shutdown at the end of the month — or wait and see if the Senate will take action to move its funding extension to mid-December.”
  • Per Healthcare Dive,
    • “More than 300 telehealth and provider organizations are urging Congress and the Biden administration to extend pandemic-era virtual prescribing flexibilities for controlled substances before they expire at the end of the year.
    • “In letters sent to Congressional leaders Tuesday, the groups asked lawmakers to pass a two-year extension of the flexibilities, which allowed clinicians to prescribe some controlled substances via telehealth without an in-person evaluation. The organizations, who want the extension included in an end-of-year legislative package, also pushed the White House to work with the Drug Enforcement Administration and other agencies to avoid an expiration of the telehealth prescribing changes.
    • “The groups argue the window for proposing a new rule is rapidly closing, and an extension would give regulators more time to figure out how to balance access to care and drug enforcement.”
  • Federal News Network discusses FEHB coverage of GLP-1 weight loss drugs.
  • Reg Jones, writing in FedWeek, explains the scope of retiree benefits for Benefits for those with less than a full federal career.
  • KFF posted “a new KFF analysis finds that federal spending on Medicare Advantage bonus payments will total at least $11.8 billion in 2024, a decrease of $1 billion from last year.” 

From the public health and medical research front,

  • NBC News reports,
    • “The number of pregnant women forced to travel farther to deliver their babies — or go without prenatal care entirely — is growing.
    • “A March of Dimes report published Tuesday found that over a third of U.S. counties (35.1%) are what the group calls “maternity care deserts,” meaning they don’t have a single doctor, nurse, midwife or medical center specializing in maternity care.
    • “More than 2.3 million women of childbearing age lived in one of these counties in 2022, when the data was collected for the new report, up from 2.2 million in 2020.
    • “The number of babies born in these counties also rose, from 146,000 to more than 150,000. 
    • “It’s getting worse over time,” said Ashley Stoneburner, lead report author and director of applied research and analytics at the March of Dimes.”  * * *
    • “States in which pregnant women had to travel the farthest to seek medical maternity care included Alaska, Hawaii and Montana.”
  • The New York Times informs us,
    • “About one in six adults — and about a quarter of adults younger than 30 — use chatbots to find medical advice and information at least once a month, according to a recent survey from KFF, a nonprofit health policy research organization.
    • “Supporters hope A.I. will empower patients by giving them more comprehensive medical explanations than a simple Google search might. “Google gives you access to information. A.I. gives access to clinical thought,” said Dave deBronkart, a patient advocate and blogger.
    • “Researchers know very little about how patients are using generative A.I. to answer their medical questions. Studies on this topic have been largely focused on hypothetical medical cases.
    • “Dr. Ateev Mehrotra, a public health researcher and professor at Brown University who studies patient uses for A.I. chatbots, said he doesn’t think experts have grasped just how many people were already using the technology to answer health questions.
    • “We’ve always thought that this is something coming down the pipe, but isn’t being used in big numbers right now,” he said. “I was quite struck by such a high rate” in the KFF survey.”
  • The National Cancer Institute posted its most recent cancer information highlights on the following topics: “Young Adults | Ancient Viruses | Cell Therapy.”
  • Per a National Institute of Health press release,
    • “Newborns who had an atypical pattern of metabolites were more than 14 times as likely to die of sudden infant death syndrome (SIDS), compared to infants who had more typical metabolic patterns, according to a study funded in part by the National Institutes of Health. Metabolites are molecules produced by the body’s various chemical reactions. Researchers found that infants who died of SIDS had a specific pattern of metabolites compared to infants who lived to their first year. The researchers believe that checking for this pattern could provide a way to identify infants at risk for SIDS. The study was conducted by Scott Oltman, M.S., of the University of California San Francisco School of Medicine, and colleagues. It appears in JAMA Pediatrics.
    • “SIDS is the sudden, unexplained death of an infant younger than 1 year of age that remains unexplained after a complete investigation.​ From more than 2 million infants born in California, researchers compared newborn screening test results of 354 SIDS cases to those of 1,416 infants who survived to at least one year old. The state screens all its newborns for many serious disorders. Test results include checking for metabolites that are markers for disorders and conditions. In the study, infants identified with the highest risk metabolic profile involving eight metabolites were 14.4 times more likely to have SIDS than infants with the lowest risk metabolic profile.
    • “The authors say that testing for metabolic patterns may provide a way to identify infants at risk for SIDS soon after birth, which could inform efforts to reduce SIDS risk. Similarly, research on the biochemical pathways that produce the metabolites linked to SIDS may yield insights into the causes of SIDS and ways to reduce its risk. NIH funding for the study was provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).”
  • Per Fierce Healthcare,
    • “Remote physiologic monitoring company Cadence released data showing that rural patients at Lifepoint Health clinics who took part in Cadence’s Type 2 diabetes and hypertension programs had better outcomes than their urban counterparts.
    • “The data are a result of the companies’ three-year partnership. Brentwood, Tennessee-based Lifepoint is deploying remote monitoring throughout its 60 community hospital campuses, more than 60 rehabilitation and behavioral health hospitals and more than 250 other sites of care. Together, they are serving 4,600 patients. About two-thirds of patients in the remote monitoring programs for diabetes and hypertension lived in rural or underserved areas.
    • “The data, released Wednesday by Cadence, show that 10% more patients achieved their target blood glucose level in rural areas than patients in urban areas—63% compared to 53%—and they achieved better blood glucose reduction.”
  • Per BioPharma Dive,
    • “Sanofi and Regeneron plan to make a second attempt at expanding use of their blockbuster drug Dupixent to people with a chronic skin condition that causes hives.
    • “The Food and Drug Administration rejected the companies’ initial application in chronic spontaneous urticaria, or CSU, last year, requesting additional efficacy data to support the new use. On Wednesday, Sanofi and Regeneron said they now have the results they need to try again and said they plan to submit a new application to the FDA by the end of the year.
    • “The trial, known as LIBERTY-CUPID Study C, enrolled patients with CSU who had uncontrolled symptoms and were taking antihistamines. Patients who added Dupixent to their treatment regimen had almost a 50% reduction in itch and urticaria activity scores, compared with those who received a placebo, Sanofi and Regeneron said.”

From the U.S. healthcare business front,

  • Beckers Hospital Review ranks 36 health systems by second quarter 2024 revenue.
  • ALM Benefits Pro tells us, “U.S. employer health plan medical spending has been rising more quickly for the plan enrollees who rank in the top 10% in terms of claims than for other enrollees, researchers report in a new paper published by the American Journal of Managed Care.”
  • Modern Healthcare reports,
    • “Aetna is leaning into technology it believes will alleviate patient and provider headaches from burdensome utilization management rules, Chief Medical Officer Dr. Cathy Moffitt said.
    • “To expedite care and reduce administrative obstacles, the health insurance company intends to automate about one-third of preapproval requests from providers this year, Moffitt, also a senior vice president at parent company CVS Health, said in an interview. But Aetna is walking a fine line as health insurers face backlash over how they incorporate technologies such as algorithms and artificial intelligence into the preapproval process.”
  • and
    • “Steward Health Care received approval from a U.S. Bankruptcy Court judge to sell three of its Florida hospitals to Orlando Health in a $439 million deal. 
    • “Orlando Health, the highest bidder for the facilities, is acquiring Melbourne Regional Medical Center, Rockledge Regional Medical Center and Sebastian River Medical Center, all in Florida, according to a Tuesday court filing.”
  • Per Fierce Healthcare,
    • “More Kaiser Permanente members in Colorado will soon be able to visit CommonSpirit Health hospitals for their inpatient and emergency care, the nonprofit giants announced Tuesday.
    • “Beginning “in early 2025,” Kaiser will integrate physicians and other employees into four Metro Denver area hospitals—St. Anthony Hospital in Lakewood, St. Anthony North Hospital in Westminster, Longmont United Hospital in Longmont and OrthoColorado Hospital (an orthopedic and spine specialty hospital) in Lakewood.
    • “Physicians who will be working at these centers under the strategic partnership will include hospitalists and surgeons alongside specialists such as cardiologists and pulmonologists, according to the announcement.”

Thursday Miscellany

David Ermer–AHRQ, CMS, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Per an HHS press release,
    • “Today, leaders from the U.S. Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP), and the Substance Abuse and Mental Health Services Administration (SAMHSA) joined recovery advocates to kick off observance of the 35th National Recovery Month at the second annual SAMHSA Walk for Recovery. The National Walk for Recovery supports and celebrates recovery from substance use and/or mental health conditions while reducing stigma.
    • “In addition to hosting the walk, SAMHSA published the Gallery of Hope which features over 250 visual art entries submitted to the Art of Recovery project. The gallery highlights the transformative impact of art on mental health and substance use recovery. * * *
    • “Recovery Month, observed every September since 1989, promotes evidence-based substance use disorder and mental health treatment and recovery support practices and serves as an opportunity to celebrate the achievements of tens of millions of people in recovery and reduce stigma surrounding substance use and mental health issues. Over 65 million people consider themselves in recovery from substance use and/or mental health issues according to the 2023 National Survey on Drug Use and Health (NSDUH), among adults 18 or older in America. SAMHSA’s National Recovery Month Toolkit is available online and features recovery resources, social media assets, and weekly themes and messaging.”
  • American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services Sept. 5 published a list of participants for the Transforming Episode Accountability Model. TEAM is a mandatory payment model that will bundle payment to acute care hospitals for five types of surgical episodes. The AHA June 10 urged CMS to make the model voluntary, however the mandatory model was finalized in the CY 2025 Inpatient Prospective Payment System Final Rule.”
  • Per Fierce Pharma,
    • “A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. The FDA has converted Filspari’s conditional nod in the kidney disease IgA nephropathy (IgAN) into a full approval.
    • “As part of the conversion Thursday, the FDA has removed a specific urine protein level requirement from Filspari’s label. Now, the only condition for treatment with Filspari is that patients be at risk of disease progression.
    • The adjustment will allow Filspari to reach more patients who’re at lower risk of progression, Travere CEO Eric Dube, Ph.D., said in a recent interview. The company will be able to promote Filspari’s ability to preserve kidney function, and the full approval could give more doctors confidence to start using the drug, he added.
    • During a drug launch, “those later adopters oftentimes look for things like guidelines, support or advocacy from their peers, or in this case, also full approval,” Dube said. “So we do expect that there’s going to be a broader set of nephrologists prescribing.”
  • Federal News Network informs us,
    • “The Postal Service is bringing back a holiday surcharge for some of its package services, as the agency prepares for its busy year-end peak season.
    • “The new prices will take effect on Oct. 6, 2024, and will last through Jan. 19, 2025. USPS announced the return of the holiday surcharge in a press release Thursday.
    • “USPS waived the surcharge last year, in the hopes that that lower prices would help the agency capture a bigger share of the lucrative holiday package business from private-sector competitors like UPS, FedEx and Amazon.
    • “USPS said in a press release Thursday that the temporary price adjustment will “help cover extra handling costs to ensure a successful peak season.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “The California Department of Food and Agriculture Aug. 30 reported cows in three dairy herds tested positive for bird flu. No human cases were confirmed in association with this incident. Both the California Department of Health and the Centers for Disease Control and Prevention consider the risk of bird flu to the general public as low. As of yesterday, there have been 13 total positive cases of H5 bird flu in humans, according to the CDC.” 
  • The New York Times reports,
    • “The number of teenagers who reported using e-cigarettes in 2024 has tumbled from a worrisome peak reached five years ago, raising hopes among public health officials for a sustained reversal in vaping trends among adolescents.
    • “In an annual survey conducted from January through May in schools across the nation, fewer than 8 percent of high school students reported using e-cigarettes in the past month, the lowest level in a decade.
    • “That’s far lower than the apex, in 2019, when more than 27 percent of high school students who took the survey reported that they vaped — and an estimated 500,000 fewer adolescents than last year.
    • “The data is from the National Youth Tobacco Survey, a questionnaire filled out by thousands of middle and high school students that is administered each year by the Food and Drug Administration and the Centers for Disease Control and Prevention.”
  • The Washington Post points out,
    • “A new study adds to a growing body of evidence that Parkinson’s disease, long believed to have its origins in the brain, may begin in the gut.
    • “Gastrointestinal problems are common in patients with neurodegenerative disorders, to the point where a condition known as “institutional colon” was once thought to afflict those who lived in mental health institutions. In Parkinson’s disease, the entire gastrointestinal tract is affected, causing complications such as constipation, drooling, trouble swallowing and delayed emptying of the stomach. These symptoms often appear up to two decades before motor symptoms such as rigidity or tremor.
    • “People have, for the longest time, described Parkinson’s disease as a top-down disease — so, it starts in the brain and then percolates down to the gut, and that’s why patients have issues with their gastrointestinal tract,” said study author Subhash Kulkarni, an assistant professor at Beth Israel Deaconess Medical Center. “Another hypothesis suggests that, in many patients, it may be a bottom-up approach, where it starts in the gut and goes all the way up to the brain.”
    • “Kulkarni and his colleagues found that people with upper gastrointestinal conditions — in particular, ulcers or other types of damage to the lining of the esophagus, stomach, or upper part of the small intestine — were far more likely to develop Parkinson’s disease later in life. The study was published online Thursday in JAMA Network Open.”
  • The NIH Director writes in her blog,
    • “Each year in the U.S. there are about 18,000 new spinal cord injuries, which damage the bundle of nerves and nerve fibers that send signals from the brain to other parts of the body and can affect feeling, movement, strength, and function below the injured site. A severe spinal cord injury can lead to immediate and permanent paralysis, as our spinal cords lack the capacity to regenerate the damaged tissues and heal.
    • “So far, even the most groundbreaking regenerative therapies have yielded only modest improvements after spinal cord injuries. Now, an NIH-supported study reported in Nature Communications offers some new clues that may one day lead to ways to encourage healing of spinal cord injuries in people. The researchers uncovered these clues through detailed single-cell analysis in what might seem an unlikely place: the zebrafish spinal cord.
    • “Why zebrafish? Unlike mammals, zebrafish have a natural ability to spontaneously heal and recover after spinal cord injuries, even when the injuries are severe. Remarkably, after a complete spinal cord injury, a zebrafish can reverse the paralysis and start swimming again within six to eight weeks. Earlier studies in zebrafish after spinal cord injury found that this regenerative response involves many types of cells, including immune cells, progenitor cells, neurons, and supportive glial cells, all of which work together to successfully repair damage. * * *
    • “In future work, the researchers plan to conduct similar studies in the many other cell types known to play some role in spinal cord healing in zebrafish, including supportive glia and immune cells. They’re also continuing to explore how the activities they see in the zebrafish spinal cord compare to what happens in mice and humans. With much more study, these kinds of findings in zebrafish may lead to promising new ideas and even treatments that encourage neural protection, flexibility, and recovery in the human nervous system after spinal cord injuries.”
  • The “Institute for Clinical and Economic Review publishes Evidence Report on treatments for Transthyretin Amyloid Cardiomyopathy — Current evidence suggests that tafamidis and acoramidis provide a net health benefit when compared to no disease-specific therapy; these treatments would achieve common thresholds for cost-effectiveness if priced between $13,600 to $39,000 per year.” * * * “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC on September 20, 2024.”
  • The U.S. Preventive Services Task Force posted a final research plan for “Early Allergen Introduction to Prevent Food Allergies in Infants: Counseling.
  • Per Reuters,
    • “There is no link between mobile phone use and an increased risk of brain cancer, according to a new World Health Organization-commissioned review of available published evidence worldwide.
    • “Despite the huge rise in the use of wireless technology, there has not been a corresponding increase in the incidence of brain cancers, the review, published on Tuesday, found. That applies even to people who make long phone calls or those who have used mobile phones for more than a decade.”
  • FEHBlog comment: Whew!
  • Per MedPage Today,
    • “Having a medical condition was associated with an increased risk of suicide in a dose-response-like manner, such that the higher the burden of disability, the higher the risk of suicide, according to an observational study in Denmark.
    • “An analysis of more than 6.6 million people found that nine medical condition categories including 31 specific conditions were associated with a statistically significant increased risk of suicide, with the exception of endocrine disorders, reported Søren Dinesen Østergaard, MD, PhD, of Aarhus University Hospital, and co-authors.
    • “The associations were most pronounced for gastrointestinal conditions (incidence rate ratio [IRR] 1.7, 95% CI 1.5-1.8), cancers (IRR 1.5, 95% CI 1.4-1.6), and hematological conditions (IRR 1.5, 95% CI 1.3-1.6), they wrote in JAMA Psychiatry.
    • “The risk was highest in the first 6 months following diagnosis and subsequently faded over time, although the risk after certain medical conditions remained elevated up to 15 years after onset.”

From the U.S. healthcare business front,

  • Beckers Payer Issues provides context to Modern Healthcare’s story in yesterday’s post about HCSC offering a no deductible plan design. It’s a trend.
  • Modern Healthcare adds today,
    • “Cigna Group CEO David Cordani underscored the booming state of the company’s health services business and outlined the unit’s potential growth opportunities during Morgan Stanley’s annual Global Healthcare Conference on Thursday.
    • “Cordani said the company sees opportunities to capitalize on the $400 billion specialty pharmacy market and to drive more business for its pharmacy benefit manager, Express Scripts.
    • “Cigna has been charting strong growth this year for its Evernorth Health Services business as it pulls out of the lucrative Medicare Advantage market, and it’s already seeing positive returns. Evernorth, which houses Cigna’s specialty pharmacy and pharmacy benefits businesses, generated more than 80% of its total revenue in the second quarter ended June 30.
    • “Cordani highlighted Evernorth’s successes as the segment announced another low-cost biosimilar product. Early next year, eligible members will have access to a biosimilar for Johnson & Johnson’s Stelara arthritis drug with no out-of-pocket cost at its specialty pharmacy. Cordani said the new offering could save each member $4,000 annually.”
  • Per Fierce Healthcare,
    • “Over the past several years, Humana has made significant strides in growing its senior-focused primary care business, and a new study highlights areas where it’s seeing success in this model.
    • “The study, conducted by the Humana Healthcare Research team along with Harvard researcher J. Michael McWilliams, M.D., Ph.D., digs into data from six senior-focused primary care organizations on more than 421,000 patients who were enrolled in Medicare Advantage coverage in 2021.
    • “It found that patients in these organizations had 17% more primary care visits across the board. This included 39% more visits among Black patients and 21% more among low-income patients, which can address disparities faced by these populations.
    • “The study also suggests that patients who are engaged with a senior-focused primary care model see better outcomes on multiple quality measures including cancer screenings, medication adherence and controlled blood pressure. The researchers did note that future analysis is necessary to refine these findings.”
  • Modern Healthcare notes,
    • “Ochsner Health is expanding its digital medicine program to offer weight management, the health system said Wednesday.
    • “Some [program] patients will have access to popular weight loss medications including glucagon-like peptide agonists, Ochsner said in a release. The digital medicine program has previously focused on patients with hypertension, Type 2 diabetes and hyperlipidemia.” * * * 
    • “Ochsner is the latest organization seeking to leverage the popularity of GLP-1 medications such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. GLP-1s have led many organizations to offer virtual weight management services, including Mayo Clinic. The Rochester, Minnesota-based organization said in January it’s testing a telehealth weight loss offering through its diet program.”  
  • Per Healthcare Dive,
    • “Henry Ford Health and Ascension will launch their joint venture in Michigan at the start of October, moving eight Ascension and Genesys hospitals and an addiction treatment center under the Henry Ford brand, the companies said on Wednesday.
    • “Detroit-based Henry Ford will double in size once the joint venture launches, growing its acute care footprint from five to 14 hospitals.
    • “The no-cash deal, announced nearly a year ago, is expected to create an organization with more than $10.5 billion in annual operating revenue. Henry Ford CEO Bob Riney will serve as the CEO of the new entity.”
  • and
    • “Female physicians and doctors who work in nonrural practices deliver more care via telehealth, according to a study published this week in Health Affairs. 
    • “The research also found differences in virtual care utilization by specialty. For example, 23% of psychiatrists delivered all or nearly all of their visits through telehealth, compared with fewer than 1% for physicians in all other specialties. 
    • “The findings offer insight into long-term patterns of telehealth utilization in the U.S. and help show how virtual care might be affecting care access and outcomes, the study authors wrote.”
  • Per Kauffman Hall,
    • Hospital financial performance remains strong this year, with continued stabilization in the month of July. Outpatient revenue and average lengths of stay showed signs of improvement.
    • The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for July was 4.1%.
    • The recent [/July] issue of the National Hospital Flash Report covers these and other key performance metrics.
  • Per MedTech Dive,
    • “Abbott is working to integrate its newest continuous glucose monitor (CGM) with Beta Bionics’ automated insulin delivery (AID) system.
    • “The companies plan to connect Beta Bionics’ iLet Bionic Pancreas to Abbott’s Freestyle Libre 3 Plus CGM, according to the Wednesday announcement. Readings from the CGM will help iLet calculate insulin doses for automated delivery.
    • “Beta Bionics said the integration, which is scheduled to launch in the fourth quarter, will be the first of its kind for Freestyle Libre 3 Plus in the U.S. Abbott also has AID partnerships with Insulet and Medtronic.”

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • AARP tells us,
    • “By 2029, more than 4 million people with a Medicare drug plan who do not receive the program’s low-income subsidy will hit the annual [$2000 out of pocket cost] ceiling and see savings when they go to fill their prescriptions, according to a new report published by AARP. * * * [The new cap takes effect January 1, 2025.] * * *
    • “The amount of money each person will save under the new law [the Inflation Reduction Act (IRA)}will vary depending on the medications a person takes and how much they have to pay for them. An estimated 1.4 million adults with a Medicare prescription drug plan who reach the new out-of-pocket cap between 2025 and 2029 are expected to see an average annual savings of $1,000 or more, the AARP report shows. More than 420,000 Medicare Part D enrollees will save $3,000-plus.”
    • This is one on many reasons why FEHB annuitants with Part A or B coverage should consider enrolling in an FEHB Part D EGWP plan or Medicare Advantage with Prescription Drugs (MAPD) plan for 2025. Of course, under OPM’s proposed rule, PSHB annuitants would lose their PSHB drug coverage if they opt out of participating in a Part D EGWP plan or an MAPD for 2025. The FEHBlog does not understand why OPM finds it necessary to create an opt out penalty in view of the generous Part D benefits available next year.
  • Fierce Pharma points out a report finding that the IRA’s provisions intended to juice the sales of biosimilar drugs to hospitals has had limited impact so far.
  • Per a Congressional press release,
    • “House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) today [August 28] is calling on the CEOs of three major Pharmacy Benefit Managers (PBMs)—CVS Caremark, Express Scripts, and Optum Rx—to correct the record for statements made during their appearance before the House Oversight Committee at a hearing titled, “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part III: Transparency and Accountability.”
    • “‘At the House Oversight Committee’s hearing, the PBM chief executives made statements that contradict the Committee’s and the Federal Trade Commission’s findings about the PBMs’ self-benefitting practices that jeopardize patient care, undermine local pharmacies, and raise prescription drug prices. The chief executives for CVS Caremark, Express Scripts, and Optum Rx claimed they do not steer patients to PBM-owned pharmacies. The executives also made claims contradicting the Committee’s and FTC’s findings regarding contract negotiations, contract opt outs, and payments to pharmacies.”
    • The PBM replies are due by September 11, 2024. 
  • Tammy Flanagan, writing in Govexec, fills us in on Social Security survivor benefits.
  • Per a HRSA press release,
    • “Today, the Health Resources and Services Administration (HRSA) announces that for the first time in the 40-year history of the Organ Procurement and Transplantation Network (OPTN), the OPTN Board of Directors—the governing board that develops national organ allocation policy—is now separately incorporated and independent from the Board of long-time OPTN contractor, the United Network for Organ Sharing (UNOS). HRSA has awarded an OPTN Board Support contract to American Institutes for Research to support the newly incorporated OPTN Board of Directors. 
    • “These critical actions to better serve patients by breaking up the monopoly that ran the nation’s organ allocation system are part of the OPTN modernization plan announced by HRSA in March 2023. Prior to these steps, the national body responsible for developing organ allocation policy for the country—the OPTN—and the corporate entity contracted to implement the policy—UNOS—shared the exact same Board of Directors. The new board support contractor will be accountable to HRSA and will organize a special election for a new OPTN Board of Directors with a focus on eliminating conflicts of interest and ensuring that data, evidence, and the voices of clinical leaders, scientific experts, patients, and donor families are driving action and accountability. Moving forward, no member of the OPTN Board can sit on an OPTN vendor’s board of directors.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration announced a final rule that raises the minimum age for certain restrictions on tobacco product sales. These requirements are in line with legislation signed in December 2019 that immediately raised the federal minimum age of sale of tobacco products in the United States from 18 to 21 years of age. Once implemented, the requirements are expected to help decrease underage tobacco sales.  
    • “Beginning Sept. 30, retailers must verify with photo identification the age of anyone under the age of 30 who is trying to purchase tobacco products, including e-cigarettes. Previously, this requirement applied to anyone under the age of 27. It’s important for retailers to request and examine photo IDs to verify age from anyone under 30, regardless of appearance, as research has shown that it is difficult for retailers to accurately determine the age of a customer from appearance alone. 
    • “Additionally, starting Sept. 30, retailers may not sell tobacco products via vending machine in facilities where individuals under 21 are present or permitted to enter at any time. Previously, this prohibition applied to facilities where individuals under 18 were present or permitted to enter at any time. These, and the other changes made by the final rule, aim to maximize the public health impact of the original December 2019 legislation.”
  • The American Hospital Association lets us know,
    • “The U.S. Department of Health and Human Services will not appeal its loss in American Hospital Association v. Becerra. The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, last November sued HHS to bar enforcement of a new rule adopted in guidance by the Office for Civil Rights titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates,” which prevented hospitals and health systems from using standard third-party web technologies that capture IP addresses on key portions of their public-facing webpages. A federal district court in the Northern District of Texas June 20 held that the OCR bulletin’s new rule “was promulgated in clear excess of HHS’s authority under HIPAA.” HHS Aug. 29 officially withdrew its notice of appeal, finalizing the AHA’s victory in this case.”

From the public health and medical research front,

  • The New York Times reports,
    • “The death toll of people who consumed products tainted with listeria that have been linked to Boar’s Head deli meats has risen to nine over the last three weeks, the Centers for Disease Control and Prevention said on Wednesday.
    • “In total, 57 people have been hospitalized because of the bacteria in the outbreak that started in May, the C.D.C. said. 
    • “As a result of the outbreak, the company has recalled millions of pounds of meat. The recall includes about 70 products — including those made from ham, beef and poultry — that were manufactured at its plant in Jarratt, Va. The recall mostly affects products that are sliced at the deli counter, the company said in a statement on its website.
    • “The six new deaths are one person from Florida, one person from Tennessee, one from New York, one from New Mexico and two people from South Carolina, according to health officials.”
    • “The C.D.C. is warning people not to eat the recalled deli meats. Health officials are telling consumers to check their fridges for any recalled Boar’s Head products. (The C.D.C. is telling people to look for “EST. 12612” or “P-12612” inside the USDA mark of inspection on the product labels. Some of the products have sell-by dates that last until October 2024.)”
  • The Wall Street Journal informs us,
    • “Shingles, also called herpes zoster, is a viral infection caused by the reactivation of the virus that also causes chickenpox. The virus remains dormant in the body of anyone who’s ever had chickenpox, and can reactivate at any time.
    • “Most of us think shingles is an old person’s disease and don’t even think about it until our 60s or 70s, especially since the vaccine was long recommended for people aged 60 and over. But the reality is, it can strike at any time, triggered by stress—physical or psychological—and it is often very painful. The good news is it’s often milder at younger ages.
    • “Starting in 1998, shingles rates increased across all ages for nearly two decades, including for those in their 40s, according to Centers for Disease Control and Prevention data. Rates have stabilized somewhat recently but remain higher than the 1990s.” * * *
    • “The CDC doesn’t advise getting the shingles vaccine until you’re 50 or older, at which time people typically have no out-of-pocket cost.
    • “Typically younger people experience milder cases of shingles and are less likely to develop postherpetic neuralgia, or neuropathic pain in the area where you had shingles, which can last months.
    • “But people under 50 who are immunocompromised are more at risk of developing shingles, and the CDC recommends vaccination for those people, provided they are age 18 or over.
    • “It’s unclear how long the shingles vaccine protects against infection. Doctors say it seems to offer good protection for at least up to a decade. Currently the CDC doesn’t recommend getting a booster after the initial two-shot regimen.”  
  • The National Institutes of Health Director writes in her blog,
    • “When someone receives an inactive sugar pill for their pain, the expectation of benefit often leads them to experience some level of pain relief. Researchers have long known that this placebo effect is a very real phenomenon. However, the brain mechanisms underlying the placebo effect for pain have been difficult for researchers to understand.
    • “Now, findings from an intriguing NIH-supported study in mice published in Nature offer insight into how this powerful demonstration of the mind-body connection works in the brain. Furthermore, the researchers identified a previously unknown neural pathway for pain control and suggest that specifically activating this pathway in the brain by other means could one day offer a promising alternative for treating pain more safely and effectively than with current methods, including opioids.” * * *
    • “While the experience of pain is exceedingly complex, and this research is in mice, the researchers expect that these findings will have relevance to people. The next step is to explore the role of activity in this newly discovered pain pathway in humans’ experience of the placebo effect. The hope is that with continued study it may one day be possible to target this brain area using small molecules or neural stimulation as a potentially more effective and safer means to ease pain compared to current methods.”
  • The National Cancer Institute posted its most recent cancer information highlights.
  • Cardiovascular Business points out,
    • “Artificial intelligence (AI) is being used more and more to perform opportunistic screening of computed tomography (CT) scans for a variety of diseases. This is believed to be one way care teams can potentially change the course of preventive care in the near future, and it has been a growing topic at radiology and cardiology conferences in recent years. 
    • “One study study presented at the Society of Cardiovascular CT (SCCT) 2024 meeting led by Brittany Nicole Weber, MD, PhD, director of the Cardio-Rheumatology Clinic at Brigham and Women’s Hospital, is shedding light on the potential of using opportunistic screening in CT scans to detect cardiovascular disease (CVD). This study explored the use of the HealthCCSng AI algorithm developed by Nanox, which was cleared by the FDA in 2021 to identify coronary artery calcium (CAC) in CT scans originally performed for noncardiac reasons. Weber said this strategy could significantly improve early detection and intervention in patients at risk for cardiovascular events. Coronary calcium is a marker of coronary disease on imaging and can be seen in any types of CT scans of the chest. The software can identify and quantify the calcium burden to risk stratify a patient without human intervention.
    • “Patients with autoimmune disorders are at a significantly higher risk for cardiovascular disease, largely due to systemic inflammation. However, many of these patients are not receiving the preventive therapies they need,” Weber explained in an interview with Cardiovascular Business.” 

From the U.S. healthcare business front,

  • Kauffman Hall reports,
    • “Kaufman Hall’s National Hospital Flash Report showed another month of solid performance through the first half of 2024 with a 4.1% operating margin year to date, continuing a trend of stronger performance that began in late 2023. It’s as if a light bulb turned on and has stayed on, setting up 2024 to be a better year than 2023.
    • “Before we declare victory, there are few noteworthy caveats.
      • “First, not all margins are created equally. While the month-over-month median shows improvement, the median change in margin is down, suggesting an uneven distribution of the improvement. About two-thirds of hospitals in the data through 2023 showed no change in operating margin compared to 2019. Many hospitals are running hard but running in place. This means that the improvement in the margin rests on the herculean shoulders of the remaining one third that are doing well—really well, in fact—to drive the national median up.
      • “Second, the Flash report typically reflects only a hospital’s acute care operations. If one were to add in physician enterprises and other similar non-acute care operations that negatively impact performance, margins would decline by about 200 basis points. This would bring our Calendar Year 2023 median of 2.7% in line with FY 2023 rating agency medians, which reported breakeven results.
    • “Notwithstanding these caveats, performance through the first half of 2024 suggests much improved results for full 2024. 
  • Per the Wall Street Journal,
    • “Luxury hotels such as the Waldorf Astoria, renowned for offering impeccable service to clientele, are now catering to an unexpected cadre of VIPs: newborns and their parents.
    • “Postnatal-wellness centers, modeled after ones in Taiwan and Korea, are popping up in American cities, quietly ensconced within tony hotels. For up to $1,500 per night, families leave the hospital and head to a retreat or check in for R & R later. They indulge in recovery, coaching in newborn care and pampering.
    • “Perhaps the most coveted service, however, is the 24-7 nursery staff, affording new parents that elusive treasure: sleep.”
  • Beckers Payer Issues provides seven payer executive answers to the question — what are the most dangerous trends facing payers? For example,
    • “Jen Truscott. Senior Vice President of Aetna Clinical Solutions (Hartford, Conn.):  According to the National Council on Aging, 80% of adults aged 65 and older have two or more chronic conditions. Many older adult patients seek care for health complications long after they have arisen. Care management can improve outcomes for health plan members when these programs are proactive and personalized, yet coordinated care is not utilized to its full extent across the U.S. To combat this, health plans should increase their emphasis on holistic care, effective care management programs and the power of value-based care. Our data show that four in 10 Aetna members changed their behavior — including reducing avoidable emergency room visits, improving medication adherence and choosing more cost-effective sites of care — due to our care management programs proactive outreach.”
  • HR Dive relates,
    • “Three in five U.S. workers reported living paycheck to paycheck, according to PNC Bank’s second annual Financial Wellness in the Workplace Report. And 31% of the more than 1,000 workers surveyed said they would like early access to their paycheck. 
    • “Meanwhile, 78% of the more than 500 U.S. employers surveyed said their workers were financially stressed, up from 71% in 2023. But access to financial planning benefits doubled from the previous year, jumping from 14% to 28%. 
    • “Three out of 10 workers of any generation and 4 out of 10 Generation Z workers with student loan debt report being “at a standstill” while they pay it off.”

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fedweek lets us know,
    • “Another report to Congress has estimated an annual $1 billion cost to the FEHB program from ineligible persons being covered as family members, a cost that is passed on to both enrollees and the government in the form of higher premiums.
    • “The Congressional Budget Office estimate—agreeing with one last year from the GAO—was done in an analysis of S-4035, which is pending a vote in the full Senate after Congress reconvenes September 9. A counterpart bill, HR-7868, has cleared the House committee level, as well.
    • “The bills would require agencies to verify the eligibility of dependents enrolled in the FEHB when the employee or annuitant starts or changes a dependent’s enrollment; require OPM to audit dependents’ enrollment in the program; and expand fraud risk assessments of the program to include information on ineligible enrollees. * * *
    • “CBO expects that implementing the bill would cause enrollment to decline by about 100,000 people, on average, in each year over the 2025-2034 period. Verifications of eligibility during open season would cause a decline of about 10,000 people, on average, in each year over the same period,” it says.
    • However, that estimate “is subject to significant uncertainty because no similar verification audit of the FEHB program has been undertaken,” it added.
  • FEHBlog sermonette — About ten years ago, OPM added a provision to the FEHB standards contracts providing that the carriers would foot the bill for any family member eligibility audits. OPM never has performed a verification audit due to the FEHB program’s size. However, audits are based on sampling, and surely a sample-based audit of various geographic regions where federal and postal employees live (e.g., Washington, DC and nearby counties, Texas, Florida, etc.) would have told OPM whether or not it has a family member eligibility problem.
  • OPM does have a more glaring enrollment problem because OPM separately reports enrollment and premiums to carriers. Consequently, carriers, which carry the insurance risk, do not have the opportunity to confirm that enrollees in their records (based on OPM’s data) are paying the proper premiums for selected self only or other than self only coverage. What is the sense of nailing down family member coverage when no one knows whether the enrollee is paying the proper or any premium?
  • For close to twenty years, CMS, which implements HIPAA’s electronic standards, has made available an electronic enrollment roster transaction known as the HIPAA 820, which would allow FEHB carriers to reconcile enrollment and premiums at the individual level using computer systems. That’s a massive gap in internal controls that needs to be corrected without further delay, in the FEHBlog’s humble opinion. All that OPM has to do is tell the payroll offices to use the HIPAA 820. End of sermonette.
  • Per a company press release,
    • Maximus has been awarded a $20 million contract from the Office of Personnel Management (OPM) to serve as the Contact Center Services Provider for the agency’s new Postal Service Health Benefits Program. This program will provide health insurance to eligible Postal Service employees, annuitants, and their eligible family members starting in 2025.
    • Maximus will be leading the customer support effort to answer calls and emails for OPM’s new, enhanced customer service platform dedicated to assisting eligible individuals access health insurance benefits. Maximus will leverage offerings from its Total Experience Management (TXM) solution, including state-of-the-art telephony, customer relationship management, and call quality reporting tools to provide best-in-class customer service.
    • “The Postal Service Health Benefits Program is an invaluable benefit for the U.S. Postal Service workforce, and Maximus is uniquely positioned to develop this new contact center and Customer Experience (CX) approach based on more than 30 years of experience working with OPM,” said Larry Reagan, Senior Managing Director, Federal Civilian Market, Maximus. “Our senior team has vast experience standing up new customer service programs at scale for federal agencies to deliver a range of services, including disaster recovery, education, and health benefit services.”
  • Healthcare Dive tells us,
    • “An expensive drug for weight loss could become one of Medicare’s costliest medications, even if the majority of patients are ineligible for coverage, according to a study published on Monday in the Annals of Internal Medicine.
    • “The analysis found 3.6 million people are highly likely to be eligible for semaglutide like Wegovy, a GLP-1 that’s effective at treating obesity. More liberal definitions of eligibility could increase that number to 15.2 million patients.
    • “If all newly eligible patients received semaglutide, spending in Medicare’s Part D prescription drug benefit could increase by $34 billion to $145 billion each year, according to the study. Even if the government narrowly defined eligibility, federal spending on the medicine could still exceed $10 billion annually.”
  • Medscape adds,
    • “Now that the U.S. government has negotiated prices for some Medicare program drugs effective in 2026, Wall Street analysts are betting on a 2027 list that will include Novo Nordisk’s blockbuster Ozempic for diabetes and have a limited impact on Big Pharma. [FEHBlog note — Wegovy is the weight loss version of Ozempic. Medicare by statute does not cover weight loss drugs.]
    • “Other possible 2027 candidates include Pfizer’s cancer drugs Ibrance and Xtandi, GSK’s asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta, Teva’s Huntington’s disease treatment Austedo and Abbvie’s irritable bowel syndrome drug Linzess, according to five analysts as well as researchers and company executives.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced more than $558 million in funding to improve maternal health, building on the Biden-Harris Administration’s commitment to reducing the nation’s high maternal mortality rate through the White House Blueprint for Addressing the Maternal Health Crisis. The Health Resources and Services Administration (HRSA), an agency of HHS, is awarding more than $440 million in funding to expand voluntary, evidence-based maternal, infant, and early childhood home visiting services for eligible families across the country. In addition, the Centers for Disease Control and Prevention (CDC) announced a new investment of $118.5 million, over five years, to 46 states, six territories, and freely associated states to continue building the public health infrastructure to better identify and prevent pregnancy-related deaths.” * * *
    • “For a complete list of Maternal, Infant, and Early Childhood Home Visiting Program awardees, visit https://mchb.hrsa.gov/programs-impact/programs/home-visiting/maternal-infant-early-childhood-home-visiting-miechv-program/fy24-awards.”
  • A Federal News Network Data Dive tells us, “USPS improves on-time delivery in delay ‘hotspots’, but faces year-end challenges. Postal experts say USPS improvements to on-time delivery are needed, and must continue, for Congress to allow these plans to keep moving forward.”

From the public health and medical research front,

  • Beckers Hospital Review reports on an August 23, 2024, press conference that leaders of the CDC, HHS and FDA held to discuss the upcoming respiratory virus season.
  • The American Medical Association informs us about what doctors wish their patients knew about lung cancer screening.
    • “Lung cancer causes about 160,000 U.S. deaths a year, which is greater than the toll of the next three most common cancers—colon, breast and prostate—combined. Yet only about 30% of lung cancer cases are diagnosed early. Most patients are diagnosed at a far less treatable, later stage of the disease. And with about 20% of lung cancer deaths preventable, evidence-based screening recommendations for high-risk patients offers the best hope to catch the disease early and provide the best chance for effective treatment.”
  • Medscape looks into how old is too old to undergo a screening colonoscopy.
  • The National Institutes of Health (NIH) issued a medical research report this afternoon.
  • Per an NIH press release,
    • “So-called low-intensity blood stem cell transplants, which use milder conditioning agents than standard stem cell transplants, do not appear to damage the lungs and may help improve lung function in some patients with sickle cell disease (SCD), according to a three-year study of adults who underwent the procedure at the National Institutes of Health (NIH).
    • “Damage to lung tissue and worsened lung function is a major complication and leading cause of death in people with sickle cell disease, a debilitating blood disorder. The new study, published today in the Annals of the American Thoracic Society, helps answer whether less intensive types of transplants, which tend to be better tolerated by many adults, by themselves either cause or promote further harm to the lungs.
    • “By using a low-intensity blood stem cell transplant for sickle cell disease, we may be able to stop the cycle of lung injury and prevent continued damage,” said study lead Parker Ruhl, M.D., an associate research physician and pulmonologist at NIH. “Without the ongoing injury, it’s possible that healing of lung tissue might occur, and this finding should help reassure adults living with sickle cell disease who are considering whether to have a low-intensity stem cell transplant procedure that their lung health will not be compromised by the transplant.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group’s philanthropic arm has released a new deep dive into maternal and infant health, underscoring socioeconomic disparities in women’s health.
    • “The study found that American Indian/Alaska Native, Black and Hawaiian/Pacific Islander women had maternal mortality rates that were between 2.5 and 4.5 times higher than other ethnic groups. Severe maternal morbidity was, in 2020, two times higher among Black mothers than white mothers, and 1.5 times higher among Black mothers compared to Hispanic mothers.
    • “There were also racial disparities identified in low-birth weight, according to the study. Low birth weight rates were 2.1 times higher among babies born to Black mothers compared to infants born to white mothers.
    • “There were some bright spots in the data, however. Between 2008 and 2011 and 2018 to 2021, there were improvements to infant mortality rates among some racial groups. The study found improvements of 15% among infants born to white mothers, 12% among babies born to Black mothers and 9% for babies born to Hispanic mothers.
    • “Lisa Saul, M.D., national medical director of maternal child health at UnitedHealthcare, said in a press release that analyses like this are critical to developing targeted solutions to key challenges.”
  • Beckers Hospital Review informs us,
    • “After about 18 months since the FDA greenlit preventive COVID-19 medication Pemgarda for emergency use, the agency has tweaked its decision. 
    • “The agency has narrowed the medicine’s emergency use authorization. It is now OK to use when “the combined national frequencies of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%,” the FDA said in an Aug. 26 letter to the drug’s maker, Invivyd. 
    • “Pemgarda (pemivibart) is authorized for the pre-exposure prophylaxis of COVID-19 in some adults and children older than 12. Eligible patients are those who have a moderate-to-severe immune compromise and are unlikely to have an adequate response to a COVID-19 vaccine.
    • “Early data indicate that COVID-19 variant KP.3.1.1 may have substantially reduced susceptibility to Pemgarda. As of Aug. 17, the variant accounted for 36.8% of COVID-19 infections, according to CDC data. If this percentage surpasses 90%, Pemgarda’s emergency use authorization could be revoked.”
  • Per MedTech Dive,
    • “Insulet received U.S. clearance Monday for its Omnipod 5 system for Type 2 diabetes management — a first for the industry — making automated insulin delivery to control blood sugar available to millions of additional people living with diabetes.
    • “The system’s tubeless pump automatically adjusts insulin levels based on data from a continuous glucose monitor (CGM), replacing manual dosing. Since its approval for Type 1 patients in 2022, Omnipod 5 has become the most prescribed insulin pump in the U.S. and has more than 250,000 users globally, Insulet Chief Medical Officer Trang Ly said in an interview with MedTech Dive.
    • “Ly discussed the product’s launch for Type 2 diabetes patients, partnerships with other device makers and how the company is working to win over doctors reluctant to prescribe insulin pump therapy.”
    • Check out the interview.

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • Eli Lilly is now distributing a single-dose vial form of its popular weight loss medicine Zepbound that it says people with a valid prescription can obtain for a cash price that’s 50% less than the current cost of other GLP-1 drugs for obesity.
    • The single-dose vials are available through Lilly’s online service LillyDirect as a self-pay option, which could appeal to people without employer insurance coverage or those who don’t qualify for the company’s savings card program, Lilly said.
    • A four-week supply of Zepbound single-dose vials at a 2.5 milligram dose will cost $399, while the 5 milligram dose will cost $549. While those prices are well below the $1,060 monthly list price of Zepbound’s injector pen formulation, they’re not far from the drug’s estimated net price after accounting for rebates and discounts to insurers, according to a client note from Evercore ISI analyst Umer Raffat.
  • Per Healthcare Dive,
    • “Pfizer on Tuesday launched a direct-to-consumer service it claims will help people schedule telehealth appointments, fill prescriptions and access savings programs for the company’s migraine, COVID-19 or influenza medicines.
    • “Dubbed PfizerForAll, the online service will provide resources for people looking to obtain treatment for migraine, COVID or the flu, or to schedule vaccinations for diseases like pneumococcal pneumonia and respiratory syncytial virus.
    • “The platform aims to “streamline the path for those seeking better health,” Aamir Malik, Pfizer’s chief U.S. commercial officer, said in a statement. The company said it is working with partners UpScriptHealth, Alto Pharmacy and Instacart.”
  • MedCity News notes,
    • “Waltz Health, a digital health company focused on prescription drugs, launched Waltz Connect on Monday. The new solution aims to reduce the cost of specialty medications.
    • “Chicago-based Waltz Health was founded in 2021 and serves payers and pharmacies. It has a product called Marketplace Search, which allows users to search for any prescription and see the range of prices available at their pharmacy. It also works with health plans to bring its marketplace solutions into their pharmacy benefit.
    • “The company’s Waltz Connect product supports payers and focuses on specialty medications. When a specialty prescription is submitted for a member, Waltz Connect redirects it to the most suitable pharmacy, regardless of the pharmacy’s network status with the payer. This routing is based on the member’s benefit design and several factors, including price, turnaround time, fulfillment accuracy, member experience and adherence rates. These factors can be customized by drug class or specific drugs. Health plans also receive information on the member’s condition, prescription onboarding, the selected pharmacy’s contact information, expected fulfillment turnaround time and the number of refills.”
  • and discusses the pros and cons of artificial intelligence for health insurers. “With so much hinging on technology that is the subject of so much hype, it is important to understand where AI actually helps at present — and where it most definitely does not.”
  • Beckers Hospital Review points out,
    • “Boston-based Mass General Brigham’s Home Hospital program has expanded to 70 beds, making it the largest home hospital in the country, according to a news release shared with Becker’s.
    • “The capacity increase was accompanied by expanded clinical care teams and the creation of dedicated roles within Home Hospital created. The system has also incorporated medical assistants into the care model and expanded the ambulance services to meet growing demand.
    • “Since its launch in January 2022, the program has had more than 4,000 patient admissions and saved more than 20,000 acute care hospital-based bed days. The average patient stays in a Home Hospital bed is 5 days.”
  • and
    • Where Steward’s 31 hospitals stand
      • From seeking Chapter 11 protection on May 6 to sharing plans to close four of its hospitals across Massachusetts and Ohio that would result in a combined 2,187 layoffs, Dallas-based Steward Health Care has experienced a great deal of turbulence over the last year.
      • As the for-profit health system continues to push back bid deadlines and sale hearings for many of its hospitals, the status of each facility remains in question, leaving community members, healthcare workers and state and local lawmakers concerned.
      • Below, Becker’s has provided a list of Steward’s 31 hospitals by state, per the health system’s website, and the most recent information regarding each facility. [FEHBlog note — Beckers plans to keep this list updated.]
  • Per Fierce Healthcare,
    • “Aetna will cover intrauterine insemination as a medical benefit for eligible plans, a move the insurer called a “landmark policy change.” 
    • “Intrauterine insemination, or IUI, is usually only covered if employers offer a separate fertility benefit plan, according to an Aug. 26 news release from Aetna. 
    • “The change will apply to fully insured Aetna commercial plans. * * *
    • “Expanding IUI coverage is yet another demonstration of Aetna’s commitment to women’s health across all communities, including LGBTQ+ and unpartnered people,” Cathy Moffitt, MD, Aetna’s chief medical officer, said in the news release. “This industry-leading policy change is a stake in the ground, reflecting Aetna’s support of all who need to use this benefit as a preliminary step in building their family.”
  • Medscape adds,
    • “In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
    • “The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
    • :A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee-based firm that provides navigation and coordination services to oncology practices and insurers.”