Thursday Miscellany

Obesity

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.”

Friday Factoids

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Per an HHS press release,
    • “Today, United States Surgeon General Dr. Vivek Murthy released a Surgeon General’s Advisory on the Mental Health and Well-Being of Parents, highlighting the urgent need to better support parents, caregivers, and families to help our communities thrive.
    • “Over the last decade, parents have been consistently more likely to report experiencing high levels of stress compared to other adults. 33% of parents reporting high levels of stress in the past month compared to 20% of other adults. When stress is severe or prolonged, it can have a harmful effect on the mental health of parents and caregivers, which in turn also affects the well- being of the children they raise. Children of parents with mental health conditions may face heightened risks for symptoms of depression and anxiety and for earlier onset, recurrence, and prolonged functional impairment from mental health conditions.” * * *
    • “The work of parenting is essential not only for the health of children but also for the health and future of society. Better supporting parents will require policy changes and expanded community programs that will help ensure parents and caregivers can get paid time off to be with a sick child, secure affordable childcare, access reliable mental health care, and benefit from places and initiatives that support social connection and community.” * * *
    • “You can read the full Advisory here.”
  • Fedweek recounts OPM sub regulatory guidance to carriers who are adding a Postal Service Health Benefits plan to their offerings for 2025.
    • “For the purposes of this [guidance], FEHB plan HRAs, Personal Care Accounts or similar medical funds for qualified medical expenses provided as part of the medical plan, will be referred collectively as OPM HRAs.
    • “OPM is instructing Carriers offering FEHB HDHPs and CDHPs to carry over any OPM HRA credits remaining as of December 31, 2024, for eligible Postal Service enrollees from FEHB plans to PSHB plans as detailed below. This policy is only applicable when an eligible Postal Service enrollee is enrolled in or is automatically enrolled in a PSHB HDHP or CDHP with an OPM HRA offered by the same Carrier as their 2024 FEHB plan. Those FEHB Carriers not offering a PSHB HDHP or CDHP with an OPM HRA will need to inform their Postal Service enrollees that their HRA credits will be forfeited.”

From the public health and medical research front,

  • The CDC’s Advisory Committee on Immunization Practices released recommendations for 2024-25 flu season vaccines today. Here is a link to a summary of those recommendations.
  • Beckers Hospital Review tells us,
    • “GLP-1s reduced mortality and complications from cardiovascular events, according to a study published Aug. 22 in Diabetes, Obesity and Metabolism: A Journal of Pharmacology and Therapeutics.” * * * 
    • “Jeffrey Wessler, MD, a cardiologist with New Hyde Park, N.Y.-based Northwell Health, shared his perspective on GLP-1s and patient adherence with Becker’s earlier in August. 
    • “There are certainly some downstream issues with GLP-1s,” he said. “But for adherence, which is a prime issue for many cardiac medications that work really well in a clinical trial setting, that is not really an issue. People want to take it. It is really transforming how I think about managing an early stage cardiometabolic patient.”
  • BioPharma Dive lets us know, “After an FDA rejection, here’s what’s next in the psychedelics pipeline. By rejecting the first MDMA therapy this month, the FDA signaled to the psychedelic drug field that the road to approval isn’t easy.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Kaiser Permanente’s Risant Health plans to pour well over $1 billion in capital into Cone Health after its acquisition.
    • “The nonprofit pledged a minimum of $1 billion in capital funds to Cone for five years once the deal has closed to support investments in facilities, health equity initiatives and other capital projects, according to financial documents published Tuesday.” * * *
    • “The Cone transaction is expected to close in early 2025, subject to regulatory approval. Cone would operate independently but draw resources and support from Risant. 
    • “Cone reported $164 million in net income in the first nine months of its fiscal 2024, which ends Sept. 30, compared with $104 million in the year-ago period.”
  • STAT News shares the downside of Lilly’s GLP-1 drug announcement yesterday.
    •  “[A] deeper look at the announcement suggests the new offering may not expand access as much as the company indicates. 
    • “Doctors noted that the price of the vials [of Zepbound] will still be out of reach for many patients, and only the starter doses will be offered in the vials, not the higher doses that many patients need to achieve significant weight loss. Additionally, not all patients will be able to pick up vials; they will only be available to patients who are paying for their own medication without insurance and who exclusively order through Lilly’s online portal.
    • “On the same day Lilly launched the vials, it also quietly increased costs for other patients. Before, people who have commercial insurance but don’t have coverage for Zepbound could apply for a savings coupon to get the pens, at whichever dose, for $550 a month, but on Tuesday Lilly raised that price to $650 a month — a move that wasn’t mentioned in the press release.”
  • Per MedTech Dive,
    • “Illumina said Tuesday the Food and Drug Administration has approved its TruSight Oncology (TSO) Comprehensive test.
    • ‘The test uses Illumina’s Nextseq 550Dx sequencing instrument to detect variants in 517 genes using nucleic acids extracted from solid tumor tissue samples.
    • “Illumina also received two companion diagnostic indications for the test, positioning physicians to use TSO Comprehensive to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo cancer drugs.”
  • Financial Advisor IQ informs us,
    • “The expected cost of future health care and medical expenses for a 65-year-old retiring this year has reached an average of $165,000, which is 5% more than in 2023 and more than double what it was in 2002, Fidelity Investments says in a new report.
    • “Fidelity estimates that about 10% of the total outlay will go toward out-of-pocket prescription drug costs, 43% toward Medicare Plan B and Part D premiums, and the remaining 47% to “other medical expenses,” such as co-payments and deductibles. 
    • “The study suggests that many Americans may be unprepared to manage their health in retirement: The average American estimates the total health care costs in retirement to be much less — about $75,000 — Fidelity said it found in a separate report published last year.”

Friday Factoids

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

From Washington, DC

  • Fedweek posted an August update on implementation of the Postal Service Health Benefits Program (“PSHBP”).
    • “At least one major insurance carrier, FEP Blue Cross Blue Shield, has already sent letters to current participants letting them know that a plan similar to their current plan has been conditionally approved and stating that they’ll share more details on the PSHB benefits and premiums “later this year, in time for Open Season”
    • “The USPS reports new plan details will be available as of September 15, and will be sent out via hard mail in the weeks that follow.
    • “The USPS says that participants will receive a “crosswalk letter” in late October showing the new plan into which the USPS intends to enroll them. If you agree, there’s nothing to do: you’ll be enrolled in that plan.”
  • The FEHB enrollees who may be in for a surprise are those who currently participate in an FEHB plan that is not participating in the PSHBP. In October, OPM will enroll those folks in the lowest cost nationwide plan option that is not a high deductible plan or charge associate member dues. Those folks will have an opportunity to change plans during the regular federal benefits open season. The FEHBlog expects that the PSHBP navigators will be lending a helping hand to those folks, particularly those eligible for Medicare.
  • The Postal Times reminds us,
    • “If you were an annuitant entitled to Medicare Part A (typically at age 65) as of Jan. 1, 2024, and did not enroll in Medicare Part B, you and your covered eligible family members may be able to participate in a one-time PSHB Special Enrollment Period (SEP) for Medicare Part B from April 1 through Sept. 30, 2024. Those who choose to enroll during the SEP will have the late enrollment penalty paid for by the Postal Service. Eligibility letters were sent to annuitants and eligible family members in March 2024. If you have misplaced the notification letter mailed to you or believe that you are eligible to participate in the PSHB SEP and did not receive a notification letter, call the PSHB Navigator toll-free help line at 833-712-PSHB (7742) or email retirementbenefits@usps.gov.”
  • Speaking of the Postal Service, Federal News Network lets us know,
    • “The Postal Service is planning to roll out several changes next year to drive down its operating costs and ensure more reliable service to most of its customers.
    • “USPS says the next step of its network modernization plan, which will happen next year, is to get mail and packages to their destination in fewer trips between mail processing plants and post offices.
    • “The agency expects these adjustments will not only help it squeeze $3 billion of annual overhead costs out of its operations, but enable faster delivery of mail and packages to customers within 50 miles of the agency’s largest regional mail processing plants.
    • “For customers outside that 50-mile radius, however, USPS, anticipates ”some mail and packages will experience a longer service standard,”  according to a filing submitted to its regulator on Thursday. 
    • “In those cases, mail and packages in those more rural areas will remain in transit for about a day longer before reaching their final destination.
    • “USPS, however, told the Postal Regulatory Commission that these changes will have a “net positive impact” on service for first-class mail, packages and marketing mail, and will be delivered “at the same level of service or faster,” for most customers.”
  • The American Hospital News expresses distress because
    • Johnson & Johnson announced Aug. 23 that it would be fundamentally changing the way it makes 340B pricing available for two of its most popular products, Stelara and Xarelto. Starting Oct. 15, J&J will require all disproportionate share hospitals participating in the 340B Drug Pricing Program to purchase these drugs at full price and submit data to J&J. Upon verification of the drug’s 340B status, DSHs would receive a rebate for the discounted 340B price.
    • Last week, the AHA contacted the Health Resources and Services Administration for more information as soon as it was made aware that J&J was considering these actions. HRSA notified the AHA today that it has informed J&J that its rebate model is inconsistent with the 340B statute and that this model has not been approved by the Secretary of the Department of Health and Human Services. HRSA further informed the AHA that it has told J&J that HRSA will take appropriate action as warranted.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention (“CDC”) announced today,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in many areas. * * * “Nationally, the wastewater viral activity level for COVID-19 is currently very high.“
    • “COVID-19
      • Many areas of the country are continuing to experience increases in COVID-19 activity, though other areas are experiencing declines in COVID-19 activity following increases this summer. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • RSV
      • “Nationally, RSV activity remains low.
    • Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • “High-dose (HD) and adjuvanted influenza vaccines offered the best protection for people aged 65 years and older against symptoms and hospitalization during the 2022-23 flu season, concludes a real-world study published this week in Clinical Infectious Diseases.
    • “High-dose flu vaccines contain four times the standard dose (SD), while adjuvanted vaccines contain an extra immune-boosting ingredient. In 2022, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended high-dose, adjuvanted, or recombinant (cell-based) vaccines over SD vaccines for older adults, who are at elevated risk for severe disease and flu-related hospitalization and death.”
  • The New York Times reports,
    • “After a years long lull thanks to Covid-19 precautions like isolation and distancing, whooping cough cases are now climbing back to levels seen before the pandemic, according to data from the Centers for Disease Control and Prevention.
    • “So far this year, there have been 10,865 cases of whooping cough, or pertussis, nationwide. That’s more than triple the number of cases documented by this time last year, and is also higher than what was seen at this time in 2019. Doctors say these estimates are most likely an undercount, as many people may not realize they have whooping cough and therefore are never tested.
    • “The pandemic delayed routine childhood vaccinations, including those that protect against whooping cough, and led to fewer pregnant women getting vaccinated. Those factors have likely contributed to the current uptick in cases, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center. Pertussis cases tend to peak in the summer and fall, he said, and so it’s particularly critical to be aware of the disease now, as children head back to school and respiratory illnesses pick up.”
  • Bloomberg tells us,
    • “US teenagers aren’t getting vaccinated against HPV at the same pace as before the Covid pandemic, a trend that could imperil efforts to control a common cause of cervical and other cancers.
    • “Immunization rates have stagnated for kids aged 13 to 17 for the past two years, according to data that the Centers for Disease Control and Prevention published Thursday. Meanwhile, routine shots for diseases like tetanus and meningitis have returned to pre-pandemic levels, according to the CDC survey, which analyzed results from nearly 17,000 teenagers.
    • “The trend could cause alarm among public health officials. Each year, human papillomavirus causes more than 21,000 cases of cancer in women and about 16,000 in men. * * *
    • “This is the only vaccine I know of that prevents cancer,” said Sunil Sood, a pediatrician who specializes in infectious disease at Northwell Health in New York. “Putting it like that has been known to make a difference” to parents who might be resistant to having their children vaccinated, he said.”
  • Per MedCity News, “Side Effects are Limiting GLP-1 Drug Efficacy: How Can Personalization Offer a Solution? By integrating digitization and machine learning, there is an opportunity to deliver personalized care to all patients and scale precision dosing with minimal physician involvement, maximizing the effectiveness and accessibility of these drugs.”
    • “There is a clear and unique opportunity to apply dose optimization to GLP-1s to improve real-world persistence and adherence, supporting patients to continue treatment long enough to experience the full benefits, such as positive cardiovascular outcomes. We know clinicians are seeing the need for this and are already making necessary interventions but struggling still to find a scalable solution. Pairing drugs with proven digital solutions, within a single label, can facilitate personalization across the GLP-1 market, improving the effectiveness of these drugs and diminishing side effects. Not only can pharma leverage this approach to deliver best-in-class clinical and commercial outcomes, but it also promises to revolutionize disease management, enhancing patient safety and outcomes by tailoring treatment to individual needs, truly bringing precision care to all.”
  • Pulmonary Advisor notes, “About two-thirds of adults who smoked wanted to quit in 2022, although fewer than 10% were successful, according to study findings published in the Morbidity and Mortality Weekly Report.

From the U.S. healthcare business front,

  • EBRI offers an Issues Brief concerning “Trends in Self Insured Health Coverage; ERISA at 50.”
  • Per MedTech Dive,
    • “Stryker said Thursday it has agreed to acquire Vertos Medical, an Aliso Viejo, California-based company whose minimally invasive technology treats chronic lower back pain, for an undisclosed sum.
    • “The Vertos procedure, which can be performed in an outpatient setting, is designed to provide pain relief for patients with lumbar spinal stenosis by restoring space in the spinal canal and reducing nerve compression.
    • “This acquisition strengthens our minimally invasive pain management portfolio with differentiated treatments and expands our reach across ambulatory surgery centers,” Andy Pierce, head of Stryker’s medical and surgical equipment and neurotechnology business, said in a statement.”

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The battle to empower the federal government to negotiate lower prices for Medicare enrollees was years in the making. The war has just begun. 
    • “After years of opposition from the pharmaceutical industry and lawsuits seeking to halt the law that led to the new prices, resistance paled and legal efforts failed. The talks settled into a sometimes testy back and forth: hundreds of pages of paperwork, offers and rejected counteroffers, then rounds of meetings in windowless rooms with strict rules on how many people could attend.
    • During the meetings, many manufacturers lowered counter offers while federal officials moved up from their initial offers, said Meena Seshamani, director of the Center for Medicare and a deputy administrator of Medicare’s parent agency, the Centers for Medicare and Medicaid Services.” * * *
    • “Round two is just around the corner. 
    • “Companies and officials are already preparing for negotiations over more drugs that could take a bigger bite out of high drug costs, and possibly their bottom lines. Next up are prices of 15 more drugs the government will identify by Feb 1. 
    • “The two sides are also fighting over how the talks should work. Among the drug industry’s demands: clarity on how CMS determines the price of a drug. Drug companies are also fighting the agency’s potential changes for next year, including possibly cutting back the number of in-person meetings to fewer than three.”
  • Federal News Network informs us,
    • “Scores of House Democrats are calling on the Postal Service to adopt stricter workplace protections for extreme heat.
    • “The 77 House Democrats are calling on USPS to “immediately implement” the standards in the workplace heat rule the Occupational Safety and Health Administration (OSHA) proposed last month.
    • “Proactively implementing this rule would save lives by ensuring that your workforce is protected with the most up-to-date heat safety standards,” the lawmakers wrote in a letter to Postmaster General Louis DeJoy.
    • “The proposed rule, if finalized, would be the nation’s first-ever federal heat rule.”
  • and
    • “Federal employees on official travel will soon enjoy another bump in reimbursable travel costs, as the General Services Administration has increased per diem rates for lodging and meals.
    • “Starting Oct. 1, the reimbursable daily limit will rise to $178, from $166 last year. This increase marks the third consecutive year feds saw lodging rates go up, while rates for meals and incidental expenses (M&IE) last went up in 2022.
    • “The standard per diem lodging rate within the continental United States (CONUS) went up from $107 to $110, while the rates for M&IE increased from a range of $59 to $79, to a range of $68 to $92.
    • ‘Agencies [and experience rated FEHB contractors] use per diem rates to reimburse employees for lodging and M&IE during official travel. Even with inflation growth in the U.S. now losing steam, the continued increase in per diem rates reflect the persistent rise in overall costs that Americans face across the board.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention tells us,
    • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • COVID-19
      • “Many areas of the country are continuing to experience increases in COVID-19 activity, though other areas are experiencing declines in COVID-19 activity following increases this summer. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.”
    • Influenza
    • RSV
      • “Nationally, RSV activity remains low.”
    • Vaccination
  • Minnesota CIDRAP adds,
    • “Nationally, wastewater detections of SARS-CoV-2 are at the very high level for the second straight week. The highest levels are still in the West and South, followed by the Midwest and the Northeast. The CDC’s latest update, however, shows downward trends from high levels in the South and Midwest.” 
  • The Washington Post reports,
    • “Federal authorities are preparing to approve updated coronavirus vaccines targeting the latest virus variants late next week, a move that could make shots available before Labor Day, according to a federal health official and a person familiar with the plans who spoke on the condition of anonymity to discuss a confidential process.
    • “The mRNA shots manufactured by Pfizer-BioNTech and Moderna designed to target the KP.2 variant can hit the market within days of approval by the Food and Drug Administration. A third protein-based vaccine made by Novavax, preferred by people who are cautious about mRNA vaccines or who have had bad reactions to them, will probably take longer to be approved and will be distributed in subsequent weeks, according to the federal health official.
    • “Consumers should be able to start getting shots at pharmacies within a week after approval and at doctor’s offices soon after.”
  • and
    • “The Food and Drug Administration on Friday authorized the first at-home [, over the counter,] syphilis test amid surging cases of the bacterial infection and calls from federal health officials for innovative strategies to detect the disease.
    • “The manufacturer, NowDiagnostics, anticipates the 15-minute test called First to Know, being available in pharmacies, major retail stores and online as early as September. FDA staff hailed the new product as an advancement in testing for sexually transmitted illnesses but noted that an additional test by a health-care provider is needed to confirm a positive result.
    • “Syphilis was nearly eliminated in the 1990s, but rates have since soared to a 70-year high. Between 2018 and 2022, cases rose nearly 80 percent, according to the most recent data from the Centers for Disease Control and Prevention.
  • Per BioPharma Dive,
    • “Pfizer and BioNTech on Friday said a combination flu and COVID-19 shot they’ve been developing met one of its main goals in a Phase 3 trial but missed another, leaving the vaccine’s future in doubt. 
    • ‘The study tested Pfizer and BioNTech’s vaccine against separately administered, marketed COVID and flu shots in more than 8,000 people between the ages of 18 and 64. While the combination vaccine spurred a comparable immune response against COVID and influenza A, it didn’t meet that mark against the “B” strain of the flu.  
    • “As a result, two companies are “evaluating adjustments” that would improve the vaccine’s performance against influenza B while discussing next steps with health authorities.”
  • STAT News adds,
    • “The National Institutes of Health said Thursday that an antiviral often used to treat mpox did not resolve patients’ symptoms faster than placebo in a randomized trial.
    • “The results are notable because the drug, tecovirimat, has rarely been studied clinically for mpox, despite its wide use during the 2022 and 2023 outbreaks in the U.S. and Europe.”  
  • The American Medical Association shares “Top health tips sleep medicine physicians want you to know.”
  • Per Healio,
    • “Among a select group of women with uterine factor infertility, uterus transplant was feasible and associated with a high live birth rate after successful graft survival, data from a case series show.
    • “In an analysis of the Dallas Uterus Transplant Study (DUETS), researchers also found that although adverse events were common, including complications requiring surgical intervention, infants born to women who received a uterine transplant had no congenital abnormalities or developmental delays, though follow-up of the cohort is ongoing.
    • “We show that uterus transplantation is not only feasible and safe, but also associated with a success rate that is comparable with and even favorable to other infertility treatments,” Liza Johannesson, MD, PhD, of the Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center, told Healio. “[What is] important is that the children born after uterus transplant are healthy and developing normally.”
  • Medscape offers an interview with a Harvard medical professor about preventing dementia.
    • “Hello. This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a new report on the preventability of dementia that is both exciting and paradigm-shifting. The new study, published in The Lancet by the Lancet Commission on Dementia, estimates that close to 50% of cases of dementia worldwide can be prevented or delayed by improving 14 modifiable risk factors.”

From the U.S. healthcare business front,

  • MedCity News discusses the future of retail healthcare.
  • Behavioral Health Business lists the 40 fastest growing behavioral health companies in the U.S.
  • Per Reuters,
    • “Older Americans are having little success getting prescriptions for weight-loss drug Wegovy covered by Medicare despite the federal healthcare program’s decision to pay for patients with obesity at risk of heart disease, according to their doctors.
    • “In interviews with Reuters, seven obesity and heart disease specialists from various parts of the United States said their prescriptions for the Novo Nordisk (NOVOb.CO), opens new tab drug have been denied repeatedly by the healthcare companies that administer Medicare drug benefits, with some prescriptions approved only following an appeal for each application.”
  • Per Fierce Healthcare,
    • “Massachusetts’ governor has announced that deals in principle have been reached for Steward Health Care’s four remaining hospitals in Massachusetts.
    • “Should the deals be finalized, Lawrence General Hospital will operate both campuses of Holy Family in Haverhill and Methuen. Lifespan would take over operations of Morton Hospital and Saint Anne’s Hospital. Boston Medical Center will take over operations of Good Samaritan Medical Center.
    • “Boston Medical Center also intends to operate Saint Elizabeth’s down the line. The state is first taking control of the hospital through eminent domain, according to an announcement from the governor’s office.”

Thursday Miscellany

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

From Washington, DC

  • Fierce Healthcare lets us know,
    • “The Department of Health and Human Services’ technology office dropped a new proposed rule on Thursday that would require healthcare entities that contract with HHS to use government-certified health information technology. 
    • “One group said the proposed rule could expand ASTP/ONC’s scope beyond setting standards for electronic health records (EHRs) to include data systems used by public health entities and insurers’ information systems. The proposed rule could potentially impact the regulation of artificial intelligence and cybersecurity in healthcare, a source said.
    • “The  Office of the Assistant Secretary of Technology Policy’s proposed rule, “Acquisition Regulation: Information Technology; Standards for Health Information Technology” proposes that health IT meet ONC standards requirements when: solicitations and contracts issued by or on behalf of HHS entities involve implementing, acquiring or upgrading health IT where individually identifiable health information (IIHI) is exchanged; and, health IT is used by healthcare providers, health plans, or health insurance issuers under HHS contracts.
    • “The proposed rule would also include healthcare providers who have been eligible to participate in CMS’s health IT-focused incentive programs.”
  • MedTech Dive tells us,
    • “The Centers for Medicare and Medicaid Services shared a final notice on Wednesday for a new pathway to cover breakthrough medical devices. 
    • “The pathway, called Transitional Coverage for Emerging Technologies (TCET), is intended to expedite Medicare coverage of new medical devices. On average, it takes about five years after a device is authorized by the Food and Drug Administration to gain national Medicare and commercial insurance coverage, according to a survey by the Stanford Byers Center for Biodesign. 
    • “The CMS plans to accept up to five candidates per year for the TCET pathway, with the goal of finalizing a national coverage determination within six months of FDA market authorization for technologies that are accepted. The devices must have the FDA’s breakthrough designation, meaning they provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
    • “Medtech lobbying firm Advamed pushed back on the five devices per year cap. CEO Scott Whitaker said in a Thursday statement that the limit “demonstrates clearly to Congress the need for greater resources at CMS” and the exclusion of diagnostics from the pathway is “disappointing.” 
  • The Congressional Research Service posted a legal sidebar titled “Private Equity Investments in Healthcare: Selected Enforcement Issues.”
  • STAT News reports,
    • “A federal judge [who sits on the bench of the U.S. District Court for the Southern District of Ohio] on Thursday tossed out a U.S. Chamber of Commerce lawsuit challenging Democrats’ drug pricing law.”
    • “The decision is yet another loss for the pharmaceutical industry and its allies, which have filed lawsuits across the country arguing that the Inflation Reduction Act, which created a drug price negotiation program in Medicare, is unconstitutional. So far, they have lost every one.” * * *
    • “Because the case wasn’t filed in the correct court, Judge Newman didn’t address substantive issues about whether the law is constitutional or not.
    • “Medicare officials are expected to release the outcome of the price negotiations for the first 10 drugs in the program by Sept. 1.”
  • Per Federal Network News,
    • “The Postal Service is seeing steady growth in revenue, but not enough to outpace its substantial operating costs.
    • “USPS saw a $2.5 billion net loss for the third quarter of fiscal 2024 — higher than the $1.7 billion net loss it saw for the same period last year.
    • “USPS reported $18.8 billion in revenue this quarter — 1% higher than revenue for the same quarter last year. It’s also the agency’s fourth consecutive quarter of revenue growth.
    • “However, the agency also saw a more than 4% increase in its operating costs, which grew to more than $21 billion for the quarter.
    • “Postmaster General Louis DeJoy said Thursday that USPS plans to accelerate efforts to cut costs and boost revenue.”

From the public health and medical research front,

  • The Hill reports,
    • “Fewer U.S. adults today say it is important to get children vaccinated than in recent years, according to a Gallup poll published Wednesday.
    • “In the July survey, only 40 percent of U.S. adults said it is “extremely important” for parents to vaccinate their children, a marked decline from the 58 percent who said the same in 2019 and the 64 percent who said the same in 2001.
    • “The drop over the last two decades is similarly stark when tracking the combined percentage who said vaccinating children is either “extremely” or “very” important. Taken together, 69 percent of U.S. adults hold this view now, down from 84 percent in 2019 and from 94 percent in 2001.” * * *
    • “The poll included phone interviews conducted July 1-21, with 1,010 adults. The margin of error is 4 percentage points.”
  • The New York Times points out,
    • “Scientists have developed a new weapon against H.I.V.: a molecular mimic that invades a cell and steals essential proteins from the virus.
    • “A study published in Science on Thursday reported that this viral thief prevented H.I.V. from multiplying inside of monkeys.
    • “The new therapeutic approach will soon be tested in people, the scientists said. Four or five volunteers with H.I.V. will receive a single injection of the engineered virus. “This is imminent,” said Leor Weinberger, a virologist at the University of California, San Francisco, who led the new study.” * * *
    • “Asher Leeks, a virologist at Yale University who was not involved in the research, said that it represented a big step forward in the study of so-called cheating viruses. Researchers have been investigating them for decades, but only in recent years have scientists like Dr. Weinberger tried turning them into medical treatments.”
  • Per a Cleveland Clinic press release,
    • New Cleveland Clinic research shows that consuming foods with erythritol, a popular artificial sweetener, increases risk of cardiovascular events such as heart attack and stroke. The findings, from a new intervention study in healthy volunteers, show erythritol made platelets (a type of blood cell) more active, which can raise the risk of blood clots. Sugar (glucose) did not have this effect.
    • Published in Arteriosclerosis, Thrombosis and Vascular Biology, the research adds to increasing evidence that erythritol may not be as safe as currently classified by food regulatory agencies and should be reevaluated as an ingredient. The study was conducted by a team of Cleveland Clinic researchers as part of a series of investigations on the physiological effects of common sugar substitutes. * * *
    • “I feel that choosing sugar-sweetened treats occasionally and in small amounts would be preferable to consuming drinks and foods sweetened with these sugar alcohols, especially for people at elevated risk of thrombosis such as those with heart disease, diabetes or metabolic syndrome,” Dr. Stanley Hazen advises. “Cardiovascular disease builds over time, and heart disease is the leading cause of death globally. We need to make sure the foods we eat aren’t hidden contributors.”
  • The Wall Street Journal reports,
    • “Millions of people are flocking to drugs like Ozempic and Wegovy to lose weight and treat health problems. Doctors say one group that could benefit from the drugs is missing out: seniors.
    • “For older people, these medications can help in ways that go beyond losing weight, physicians say. Fewer pounds can lead to more mobility and better balance, allowing older people to become more active. That can boost mood, overall health, and sometimes makes the difference between walking freely or using a wheelchair or cane. 
    • “Doctors say they’re hearing more from older people who are interested in taking the drugs. However, seniors face [Medicare] insurance hurdles to get the drugs covered. And doctors note that older people need to be careful about losing muscle mass when on the drugs, as well as possible interactions with other medications.    
    • “Nine percent of people 65 and older reported taking GLP-1 medications, such as Ozempic, Wegovy and Zepbound, compared with 19% of people ages 50 to 64, according to a May KFF poll.
    • “These drugs would really benefit seniors but there’s always these additional worries,” says Dr. Sun Kim, an associate professor in the division of endocrinology at Stanford University School of Medicine. “I think sometimes we prioritize the risk over benefit when people get older.” 
  • and
    • “Doctors are now capable of saving the lives of babies born at 22 weeks and, in rare cases, a week earlier, with improved techniques to help tiny lungs develop and protect fragile skin and organs. Hospitals with extensive experience resuscitating extremely premature babies report survival rates as high as 67% for babies born at 22 weeks.
    • “Some U.S. hospitals aren’t sufficiently equipped or capable of pulling off the new advances. Others have chosen not to offer the care, saying it is likely to fail, is expensive—typically more than $100,000 a child, and sometimes much more—and subjects tiny, fragile infants to needless pain and the risk of long-term disabilities. 
    • “Instead, they often provide comfort care: wrapping the newborn in a blanket, placing it on the mother’s chest and sometimes giving medicines to ease the child’s final moments.
    • “The difference can be a matter of life or death for the roughly 8,000 infants born between 22 and 24 weeks gestation in the U.S. each year.
    • “Doctors agree that babies born at 25 or 26 weeks can and should be treated as long as they don’t have other complications, while those born at 20 weeks or less are too small to save.
    • “In between is a “gray zone,” as doctors call it, where newborns’ fate can depend on which hospital happens to be delivering.”
  • STAT News tells us,
    • “Since its emergence in 2020, Covid has jumbled the list of the 10 leading causes of deaths in the United States. It roared into third place in 2020 but has now fallen to 10th place, the National Center for Health Statistics reported Thursday. 
    • “Heart disease and cancer remained the first and second leading causes of death, followed by unintentional injuries as No. 3. Overall, deaths in 2023 were 6.1% lower than 2022.
    • “We’re going in the wrong direction for heart disease. We’re going a tad in the right direction for cancer,” said Eric Topol, founder and director of the Scripps Research Translational Institute. A cardiologist and geneticist, he was not involved in the analysis. “A lot of things that are highest on this list, there’s a lot of things we can do to prevent them. And hopefully we’ll keep seeing the numbers come down. But if you just look at pre-pandemic to now, it’s not a good trend.”
  • Per Healio,
    • “The Simplera Continuous Glucose Monitor features a one-hand, two-step insertion process for the sensor that does not require additional tape.
    • “The [recently] FDA-approved device is part of Medtronic’s smart multiple daily injection system.

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “Eli Lilly shares jumped after the drugmaker reported earnings that trumped analyst estimates and hiked its annual outlook.
    • “Lilly has become one of the most valuable companies listed in the U.S. due to the popularity of its medications used for obesity.
    • “Quarterly sales for diabetes drug Mounjaro totaled more than $3 billion, while weight-loss injection Zepbound, which launched late last year, rang in at $1.2 billion. Both figures beating analysts’ estimates.
    • “The strong quarter was boosted in part by additional supply of the drugs, which had been in shortage, as well as favorable pricing, Lilly said. Mounjaro prices were higher in the U.S., partly because of increased availability of the drug and lower use of savings card programs.”
  • Following up on a post from yesterday, BioPharma Dive informs us,
    • “[Mounjaro and Zepbound] are available in all dosage forms in the U.S. What that means is we can bill orders as they’re received,” said Lilly CEO David Ricks on an earnings conference call Thursday. “That does not mean that any pharmacy, or certainly every pharmacy, has all 12 dosage forms sitting on their shelves.”
    • “Ricks cautioned that, despite the change in status on the FDA’s shortage list, patients may still have to wait a few days to pick up their prescriptions.
    • “There’s not an abundance of supply. It’s more of a real-time fulfillment situation,” Ricks said. “But product is flowing and it’s flowing at a pretty high rate.”
    • “Still, he added, “the end pharmacy experience will continue to be choppy.”
  • Forbes adds,
    • “More doses of Novo Nordisk’s popular weight loss drug Wegovy are back in stock in the U.S. after years of shortages, according to the FDA, days after all dosage levels of Eli Lilly’s rival injection Zepbound became available. They’re part of a promising and growing class of drugs called GLP-1 agonists, but shortages are set to persist as pharmaceutical companies struggle to ramp up production.”
  • STAT News notes,
    • “As for-profit Tenet Healthcare slims its hospital portfolio, it found an unlikely buyer for its Alabama hospitals: Florida’s Orlando Health.  
    • “Orlando Health draws more than $6 billion in annual revenue and has a profit margin that surpasses most of its peers. A hospital system executive system leader said crossing state lines to buy five Birmingham-area hospitals is part of its focus on serving the Southeastern U.S., even though most of its 17 existing hospitals are still in Florida. 
    • “It’s not at all surprising that a multi-billion dollar health system would have ambitions of expanding beyond its home state. That’s especially true as hospital systems continue to merge at a breakneck pace, increasingly jumping across multiple states to do so. Meanwhile, study after study concludes that hospitals use their newfound market power to drive up prices.”
  • Per Beckers Hospital Review
    • “As the Medicare Advantage landscape evolves, the success of health systems hinges on their ability to adapt and excel in key areas such as star ratings and appropriate coding. 
    • “Health systems’ greatest opportunity is to enter into full-risk arrangements with health plans, shifting the focus from managing illness to maintaining wellness. However, many systems have not made the necessary investments to thrive in this value-based care model, often missing out on its potential benefits and driving ambivalence toward the MA program, according to SCAN Group CEO Sachin Jain, MD.”
  • Fierce Healthcare adds,
    • “Centene is exiting six states through its WellCare Medicare Advantage (MA) subsidiary next year, investment bank Stephens has revealed.
    • “Those six impacted states are Alabama, Massachusetts, New Hampshire, New Mexico, Rhode Island and Vermont, with approximately 12,600 members affected in New Mexico, the most of any state.
    • “In Vermont, Centene accounts for about 9% of the market share in the state. All told, all market exits will impact around 37,300 members and about 3% of Centene’s current MA membership, a research note from Stephens showed.
    • “Notably, CVS and UnitedHealthcare both maintain presences across each impacted market,” the brief said.
    • ‘The insurer will still offer its prescription drug plans in these states. Centene commands the most market share for standalone Part D in the country at 29%, data from the Centers for Medicare & Medicaid Services show.
  • Per Healthcare Dive,
    • “Walgreens is considering a full sale of its stake in VillageMD, after pouring billions of dollars into the unprofitable primary care chain. The decision, disclosed Wednesday in a securities filing, is a sharp reversal to the pharmacy behemoth’s past commitment to building out its healthcare delivery offerings.
    • “Walgreens is “currently evaluating a variety of options” in light of VillageMD’s “substantial ongoing and expected future cash requirements,” the company said in the 8-K. “These options could include a sale of all or part of the VillageMD businesses, possible restructuring options and other strategic opportunities.”
    • :If Walgreens offloads VillageMD entirely, it would be a step up from management’s previous plans for the value-based medical chain. In June, Walgreens said it would reduce ownership in VillageMD but not eliminate it entirely.”
  • STAT News lets us know,
    • “Digital Therapeutics developer Big Health this week received Food and Drug Administration clearance for SleepioRx, a prescription treatment for insomnia.
    • “Big Health already sells a wellness version of the app, called Sleepio, to employers and health plans that make the product available to their members. The app delivers a specialized type of cognitive behavioral therapy for insomnia and the company boasts that it is backed by dozens of studies.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics’ yearly financial outlook and quarterly earnings, including sales of Elevidys, its gene therapy for Duchenne muscular dystrophy, have fallen well short of Wall Street expectations.
    • “Sarepta reported Wednesday afternoon that Elevidys sales totaled roughly $122 million between April and June, down from the previous quarter and about $20 million below consensus estimates. Overall product sales of about $361 million, and 2025 revenue projections of $2.9 billion to $3.1 billion, were also lower than analysts anticipated.
    • “Still, executives assured investors that sales should soon climb following the recent decision by the Food and Drug Administration to substantially expand use of Elevidys. The market opportunity ahead of Sarepta is “absolutely massive,” said Dallan Murray, the company’s executive vice president and chief customer officer on a conference call. Sarepta shares initially fell by double digits before rebounding Thursday morning.”
  • Per MedTech Dive,
    • “Zimmer Biomet said Wednesday it agreed to buy Orthogrid Systems, a medtech company that makes artificial intelligence-based surgical guidance systems for total hip replacement. 
    • “Salt Lake City-based Orthogrid uses fluoroscopy imaging to help surgeons track the position of an implant during a hip procedure. It also has two other Food and Drug Administration-cleared solutions for hip preservation and trauma surgeries. 
    • “By using fluoroscopy instead of CT scans, Orthogrid can offer real-time navigation and a more efficient workflow for operating rooms.
    • “The solution will add to Zimmer’s current suite of tools for hip surgery. The company has its own hip application paired with its Rosa surgical robot that also uses fluoroscopy imaging. Zimmer additionally has a co-marketing agreement with HipInsight, which uses Microsoft Hololens 2 glasses to help surgeons visualize a patient’s pelvic anatomy during surgery. 
    • “By comparison, Stryker’s Mako total hip application uses CT imaging, while J&J’s Velys hip navigation uses fluoroscopy.”   

Monday Roundup

David Ermer–CMS, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Per an HHS press release,
    • “Today, to mark National Health Center Week, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA) released new data showing over 31 million total patients served at HRSA-funded health centers in 2023—an increase of 2.7 million since 2020.
    • “Community health centers play a pivotal, and growing, role in America’s health care system. They are especially important in our effort to reduce health care disparities in underserved communities,” said HHS Secretary Xavier Becerra. “More than 31 million people across the country – in every U.S. state, territory, and the District of Columbia – depend on health centers, making them a vital resource. The Biden-Harris Administration wants all Americans to have access to high-quality primary health care services, regardless of a patient’s ability to pay, and community health centers help make that possible.”
  • Beckers Hospital Review delves into the final Medicare acute inpatient prospective payment rule for fiscal year 2025 which was publicized last week.
  • The Wall Street Journal reports,
    • “Studies being used to decide whether the U.S. should authorize an ecstasy-based drug for traumatized patients missed serious side effects and were marked by bias.
    • “The Food and Drug Administration is expected within days to decide whether to approve the drug, known as MDMA, for treatment of post-traumatic stress disorder. Approval would be a milestone in decades of efforts to decriminalize the use of psychedelics. 
    • “Three people who were subjects in the studies told The Wall Street Journal that their thoughts of suicide worsened during or after testing, but their downward slides weren’t captured in trial data and therefore not reflected in the final results.” * * *
    • “FDA staffers have questioned the quality of the study results. Experts advising the agency recommended against approval, saying more safety and effectiveness evidence was needed. The Institute for Clinical and Economic Review, a nonprofit that reviews drugs and their prices, said the evidence was incomplete.
    • “The FDA told its advisers that it is looking into allegations of study misconduct and missing side effects. It told the Journal that it can’t comment on investigations until they are final, but its findings will be incorporated into its decision on the Lykos treatment.
    • “Problems with the trials mean the FDA might not be able to assess whether the treatment is safe and effective for everyone, or just some people, said experts advising the agency and bioethicists who spoke to the Journal about its findings.”

From the public health and medical research front,

  • USA Today lets us know,
    • “The KP.3.1.1 COVID-19 variant is the dominant strain of the virus, the latest projections from the Centers for Disease Control and Prevention (CDC) show.
    • “The agency’s Nowcast data tracker, which displays COVID-19 estimates and projections for two-week periods, projects the KP.3.1.1 variant accounting for 27.8% of positive infections, followed by KP.3 at 20.1% in the two-week stretch starting July 21 and ending Aug. 3.
    • “The KP.3.1.1 variant is very similar to other circulating variants in the United States. All current lineages are descendants of JN.1, which emerged in late 2023,” Rosa Norman, a spokesperson at the CDC, previously told USA TODAY.
    • “At this time, we anticipate that COVID-19 treatments and vaccines will continue to work against all circulating variants. CDC will continue to monitor the severity of variants and will monitor vaccine effectiveness.”
  • Bloomberg reports,
    • “Some CVS Health Corp. pharmacies are selling out of at-home Covid tests as a summer surge in infections drives up demand.
    • “As of Friday afternoon [August 2], CVS’s website showed that all brands of tests were out of stock at many locations in cities including Houston, Austin and Reno, Nevada. 
    • “The company said that 91% of its stores have at least one brand of test in stock. While the company “has seen an uptick in purchases” of the tests, it’s “quickly sending product to impacted stores,” a spokesperson said in an email.”
  • Per MedPage Today,
    • “Intermittent calorie restriction improved executive function and memory measures in cognitively intact older adults, an exploratory pilot study suggested.
    • “The 8-week randomized clinical trial of 40 overweight, cognitively normal older adults with insulin resistance examined the effect of two interventions — a 5:2 intermittent fasting plan versus a “healthy living” diet based on portion control and calorie reduction guidelines from the U.S. Department of Agriculture — on brain health. The 5:2 intermittent fasting group had 2 days of food intake of 480 calories/day (two meal replacement shakes), and 5 days of a healthy living diet.
    • “Both interventions improved executive function and memory, with intermittent fasting showing better results on certain cognitive measures, said Dimitrios Kapogiannis, MD, of the National Institute on Aging (NIA) and the Johns Hopkins University School of Medicine in Baltimore, in a poster presented at the Alzheimer’s Association International Conference.” * * *
    • “Many people think that eating a healthy diet or following an intermittent fasting regimen are good ways to stave off cognitive decline during aging, but our study actually provided supporting evidence,” Kapogiannis told MedPage Today.
    • “Our study lays the groundwork for larger clinical trials that will examine a variety of dietary interventions that will help people have good brain health and live healthier, longer lives,” he said.”
  • Beckers Clinical Leadership informs us,
    • “More than half of patients hospitalized and treated for pneumonia receive differing diagnoses during their stays, according to a study published in Annals of Internal Medicine. 
    • “Researchers from the University of Utah Health and the nearby VA Healthcare System, both based in Salt Lake City, measured the rates of concordance and discordance in pneumonia diagnoses. They followed three states: initial diagnosis in the emergency department, initial chest image reports and discharge diagnosis. 
    • “Among more than 2 million admissions at VA hospitals across the U.S., 36% of patients were admitted with a pneumonia diagnosis but not a corresponding discharge diagnosis. Another 33% had a discharge diagnosis of pneumonia but not an admission diagnosis. The study focused on admissions between 2015 and 2022.” * * *
    • “In conclusion, the authors of the latest study said physicians and patients should be aware of this high level of uncertainty about pneumonia diagnoses.

From the U.S. healthcare business front,

  • The Peterson/KFF Health System Tracker considers what drives health spending in the U.S. compared to other countries.
    • “The United States spends significantly more on healthcare than comparable countries do, and yet has worse health outcomes. Much of the national conversation has focused on spending on retail prescription drugs and insurer profits and administrative costs as key drivers of health spending in the United States. The Inflation Reduction Act, signed into law by President Biden in 2022, includes several provisions aimed at lowering the cost of these prescription drugs. While it is true that many brand-name retail prescription drugs are priced higher in the U.S. than in peer countries, health spending data indicates that other spending categories – particularly hospital and physician payments – are primary drivers of the U.S.’s higher health spending.” 
  • Risk and Insurance points out,
    • “Only about half of U.S. employers effectively manage health care costs, with nearly all organizations experiencing health plan premium increases, according to Gallagher’s 2024 U.S. Physical & Emotional Wellbeing Report.
    • “The report, which surveyed 3,552 organizations, found that employers ranked the high costs of medical services (68%) and specialty drugs (44%) as their top health care cost management challenges.” * * *
    • “Access the report on Gallagher’s website.”
  • Per BioPharma Dive,
    • “All doses of tirzepatide, the drug Eli Lilly sells as Zepbound for obesity and Mounjaro for diabetes, are now available in the U.S. after months of shortages made the in-demand medicine hard to obtain.
    • “Two dose strengths of Zepbound and another two of Mounjaro had been listed in short supply on a database maintained by the Food and Drug Administration as recently as early last week, before the agency updated the drug’s status to available on Friday.
    • “Lilly reports second quarter earnings on Thursday, when sales and supply of tirzepatide are likely to be the main focus of analyst questions. The company in April raised its financial forecasts for the year by $2 billion due to revenue growth for Zepbound and Mounjaro, which together brought in $2.3 billion between January and March.”
  • Per Healthcare Dive,
    • “Walgreens has once again cut its stake in drug distributor Cencora as the struggling pharmacy chain looks to boost funding.
    • “The Illinois-based retailer announced last week it was selling more shares in Cencora for roughly $1.1 billion in proceeds. The sales lower Walgreens’ stake in Cencora to approximately 10% from 12%.
    • “Walgreens said it will use the money to pay down debt and to fund its operations as it continues to pivot to a health services strategy.”
  • Per MedTech Dive,
    • “Johnson & Johnson said Friday [August 2] it launched Velys Spine, a surgical robot and standalone navigation platform. 
    • “The 510(k)-cleared system, which J&J developed with eCential Robotics, is designed to provide guidance on the placement of screws in freehand and robotic-assisted spine surgeries. 
    • “J&J’s Depuy Synthes plans to make the system available commercially in the first half of 2025. The system will join other Velys offerings J&J has cited as a growth driver in its hip and knee businesses.”
  • Per Fierce Healthcare,
    • “Steward Health Care will lay off about 1,200 workers in Massachusetts by the end of the month as it moves to close two hospitals in the state.
    • “The health system will let go 753 employees at its Carney Hospital and 490 workers at its Nashoba Valley Medical Center, according to a Worker Adjustment and Retraining Notification (WARN) report filed with state regulators on July 29.
    • “On Thursday, a federal judge cleared the way for embattled Steward Health Care to close Carney Hospital and Nashoba Valley Medical Center by the end of August. Those are two of the eight hospitals that the health system operates in the Bay State.”
  • and
    • “For the first time as a public company, Clover Health is announcing its first quarterly net profit, the company said ahead of its second quarter earnings call.
    • “Clover declared a net income of $7.2 million and an adjusted EBITDA of $36.2 million, both figures a substantial improvement year-over-year.
    • “I am delighted that our performance continues to validate Clover’s differentiated, technology-centric approach to healthcare, driven by our insurance offering and its ability to generate meaningful returns while leading with physician-choice for our members,” said Clover Health CEO Andrew Toy in a statement. “Through our Clover Assistant technology and integrated care management platform, we aim to empower physicians to improve clinical outcomes and lower the total cost of care for people with chronic diseases. This allows us to partner with a much wider range of physicians than other plans.”
    • “Insurance revenue also soared 11% higher year-over-year to $349.9 million due to member retention and growth, whereas the company’s medical cost ratio (MCR) improved to 71.3%, down from 77.9% the quarter before.”
  • and
    • “Cigna unveiled the first round of grant winners in a program announced earlier this year that seeks to address the rising tide of mental health needs among youth.
    • “The funding will be distributed to 22 awardees, Cigna said on Monday. For close to half of the recipients, it’s the first time they’re securing funding from Cigna or its philanthropic arm, the Cigna Group Foundation, according to an announcement.
    • “Cigna said it will distribute $9 million as part of the program. The organizations will focus on tackling post-pandemic stress and distress among kids aged five to 18, according to the release. There will be a particular emphasis on outreach in schools or related settings, Cigna said.”

Thursday Miscellany

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

From Washington, DC

  • The American Hospital Association News reports,
    • “The Centers for Medicare & Medicaid Services Aug. 1 issued a final rule that will increase Medicare inpatient prospective payment system rates by a net 2.9% in fiscal year 2025, compared with FY 2024, for hospitals that are meaningful users of electronic health records and submit quality measure data. This 2.9% payment update reflects a hospital market basket increase of 3.4% as well as a productivity cut of 0.5%. CMS expects overall payments to increase by $2.9 billion, which includes a $200 million decrease in disproportionate share hospital payments (due to a decrease in the uninsured rate), a $300 million increase in new medical technology payments, and a $400 million decrease in rural health payments if the Medicare-dependent hospital and enhanced low-volume adjustment programs are not extended by legislation.
    • “In a statement shared with the media, Molly Smith, AHA group vice president for public policy, said, “CMS’ payment updates for hospitals will exacerbate the already unsustainable negative or break-even margins many hospitals are already operating under as they care for their patients. The AHA is deeply concerned about the impact these inadequate payments will have on patient access to care, especially in rural and underserved communities.”
  • and
    • “The Centers for Medicare & Medicaid Services Aug. 1 finalized policy changes to the long-term care hospital standard rate payment system that will increase payments by 2.0%, or $45 million, in fiscal year 2025 relative to FY 2024. This includes a 3.0% market basket update, a cut of 0.5 percentage points for productivity, and a cut related to outlier payments, among other policies. Specifically, due to an increase in the outlier threshold, CMS will reduce outlier payments as a percentage of total LTCH PPS standard federal payment rate payments by 0.8%. CMS also finalized a rebasing of the LTCH market basket using a 2022 base year.  
    •  “In a statement shared with the media, Molly Smith, AHA group vice president for public policy, said, “We are troubled that the final long-term care hospital outlier threshold is nearly 30% higher than it is currently. Since FY 2021, this figure has increased by more than 180%, which forces these hospitals to absorb hundreds of thousands of dollars in additional losses when caring for the sickest patients. This increase will create serious access issues for patients and put additional burden back on acute-care hospitals and other providers that do not specialize in caring for this unique patient population.”
  • CMS also posted a guidance alert titled “Clarification of Medicare Secondary Payer (MSP) Recovery Against Awards Made Under the Camp Lejeune Justice Act (CLJA).”
  • Per a Senate Finance Committee press release,
    • “U.S. Senator Ron Wyden, D-Ore., and U.S. Senator Marsha Blackburn, R-Tenn., today introduced bipartisan legislation to address the persistent shortage of health professionals. The bill, the Health Workforce Innovation Act, provides federal support for innovative, community-led partnerships to educate and train more health care workers, especially in rural and underserved communities.” * * *
    • “The Health Workforce Innovation Act would establish a new federal grant program to support community health centers and rural health clinics to carry out innovative, community-driven models to train and develop a pipeline of a wide range of allied health professionals, including through partnerships with high schools, community colleges and other entities.” * * *
    • “The bill text is here. The one-pager is here.”  
  • MedPage Today summarizes the Federal Trade Commission’s open meeting on prescription benefit managers held this morning.
  • KFF notes,
    • “A new KFF analysis examines some of the forces that are likely to shape Medicare Part D premiums in 2025, explaining how and why premiums might change.
    • “Changes to the Part D benefit in the Inflation Reduction Act will mean lower out-of-pocket costs for Part D enrollees but higher costs for Part D plans overall, leading to concerns about possible premium increases. CMS is taking steps to mitigate potential premium increases through a new demonstration program for stand-alone drug plans, as well as payment changes designed to bring greater stability to the Part D market in 2025.
    • “The Inflation Reduction Act includes a provision to cap growth in the base beneficiary premium to 6%. Although the cap doesn’t apply to the individual premiums that plans charge, it does help to limit premium increases. Actual Part D plan premiums for 2025 will be announced in September. Medicare’s annual open enrollment period runs from October 15 to December 7.”
  • Tammy Flanagan, writing in Govexec, offers “retirement planning pro-tips for feds, some crucial tips for every stage of your federal career.”

From the public heal

  • Beckers Hospital Review lets us know,
    • “Gen Xers, born between 1965 and 1980, and millennials, born between 1981 and 1996, are at risk for 17 of the 34 existing cancer types, a new study from the American Cancer Society has revealed.
    • “An in-depth analysis of data from more than 23 million cancer patients and more than 7.3 million cancer deaths between 2000 and 2019 unveiled that incidence rates for some cancers — pancreatic, kidney, small intestinal cancers, and female liver cancer — were nearly three times higher for patients born in the 1990s than in 1955, according to the study, published July 31 in The Lancet Public Health.
    • “There were also notable increases among members of these younger generations across breast (estrogen-receptor positive), uterine corpus, colorectal, non-cardia gastric, gallbladder, ovarian, testicular, anal (male), and Kaposi sarcoma (male) cancers.
    • “Mortality rates have also increased along with the rise in cancer rates for female liver cancer, uterine corpus, gallbladder, testicular, and colorectal cancer, according to the study.
    • “The results could be “an early indicator of future cancer burden” nationwide, said Ahmedin Jemal, PhD, lead author of the study and senior vice president of surveillance and health equity science at the American Cancer Society.”
  • STAT News informs us,
    • “Eli Lilly’s obesity drug Zepbound cut the risk of complications and improved symptoms in patients with a common type of heart failure, making it the second GLP-1 drug to show positive results in the disease area after Novo Nordisk’s Wegovy.
    • “The Phase 3 trial studied patients who had heart failure with preserved ejection fraction (or HFpEF) and obesity. Some participants also had type 2 diabetes. Over two years, Zepbound cut the risk of major problems — including heart failure-related urgent visits or hospitalizations, intensification of diuretic treatment, or cardiovascular-related deaths — by 38% compared to placebo, Lilly said Thursday.
    • “Additionally, at one year, people on Zepbound had a 19.5-point improvement on the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS), a measure of symptoms, function, and quality of life. This was a 6.8-point greater improvement than patients on placebo.”
  • Medscape adds,
    • “Although obesity affects more than 1 billion people worldwide, according to a global analysis published in The Lancet, it still lacks a clear “identity” in research, social perception, and the healthcare sector. This lack of clarity hinders accurate diagnoses and treatments, while also perpetuating stigma and prejudice. Specialists argue that obesity is a chronic disease rather than just a condition that leads to other diseases.
    • “At the latest International Congress on Obesity held in São Paulo from June 26 to 29, The Lancet Commission on the Definition and Diagnosis of Clinical Obesity announced that it is conducting a global study to create a clear definition for obesity. This condition is often wrongly associated solely with individual choices. Ricardo Cohen, MD, PhD, coordinator of the Obesity and Diabetes Specialized Center at the Oswaldo Cruz German Hospital, São Paulo, Brazil, and a key researcher in the study, made the announcement. “The current definition of obesity is too broad and ineffective for our needs,” said Cohen.” * * *
    • “To address these challenges, The Lancet Commission’s study, which is expected to be published this year, aims to establish clear diagnostic criteria for adults and children. Drawing inspiration from medical disciplines with well-established diagnostic criteria, such as rheumatology and psychiatry, the research has defined 18 criteria for adults and 14 for children.”
  • The National Institutes of Health’s Director writes in her blog
    • “More than 200 million people around the world have osteoporosis, a condition that weakens bones to the point that they break easily. Women are at especially high risk after menopause due to declining levels of the hormone estrogen, which helps keep bones strong. While osteoporosis rarely has noticeable symptoms, it can lead to serious injuries when otherwise minor slips and falls cause broken bones that in turn can lead to further fracture risk and fracture-related mortality. So, I’m pleased to share NIH-supported research suggesting a surprising candidate for strengthening bones: a maternal hormone produced in the brain.
    • “The study in mice reported in Nature shows that this newly discovered hormone maintains and rebuilds bone strength in lactating females, even as estrogen levels dip and calcium is lost to the demands of milk production. 1The findings suggest this hormone—or a drug that acts similarly—could be key to treating osteoporosis and preventing and healing broken bones.
    • “The findings come from a team led by Holly Ingraham, University of California, San Francisco. The researchers knew from studies in mice and humans that a protein related to parathyroid hormone, which is made in the mammary glands, is the main driver for stripping calcium from maternal bones for milk production. As a result of this process, nursing mothers tend to lose a lot of bone. In humans, this bone loss is 10% on average, compared to nearly 30% in mice. Fortunately, these losses are reversed after lactation ends, suggesting to the researchers there must be some other bone-strengthening factor in play.” * * *
    • “In future studies, the researchers want to gain insight into the underlying mechanisms of CCN3. They also plan to explore the hormone’s potential for treating bone loss in people at increased risk, including postmenopausal women, breast cancer survivors taking estrogen blockers, and those with other conditions leading to unhealthy bone mass, such as genetic bone disorders, chronic kidney disease, or premature ovarian failure. They suggest that more immediate local uses for CCN3 include fracture repair, cartilage regeneration, and bone improvements for anchoring dental implants. It’s a great example of how finding an answer to a scientific puzzle—like how maternal bones stay strong during breastfeeding—can potentially lead to advances that help many more people.”  
  • Helio tells us,
    • “Risk for psychiatric disorder or suicide attempt is particularly high in the first year following hospitalization for heart disease, and patient support is important to lower such risk, researchers reported.
    • “A large analysis of the U.K. Biobank to understand the prevalence and risk factors for psychiatric disorder or suicide attempt following CVD hospitalization was published in the Journal of the American Heart Association.
    • “It’s crucial to pay attention to both physical and mental health after a stroke or heart disease diagnosis,” Huan Song, MD, PhD, professor of epidemiology at the West China Biomedical Big Data Center, West China Hospital, Sichuan University in Chengdu, China, said in a press release. “If you or a loved one has been hospitalized for heart disease, be aware that mental health issues may arise during recovery. It’s important to monitor for signs of anxiety, depression or suicidal thoughts. These mental health challenges are common and treatable.”

From the U.S. healthcare business front,

  • Per Beckers Payer Issues,
    • “The Cigna Group beat investor expectations and reported major growth at Evernorth in its second quarter earnings published Aug. 1.
    • “Total revenues in the second quarter were $60.5 billion, up 24.6% year over year, and primarily driven by significant growth at Evernorth. The company reported $1.5 billion in net income, up 6%.
    • “The insurance side of the business, Cigna Healthcare, reported second-quarter revenues of $13.1 billion, up 3.4% from the previous year. As of June 30, Cigna had 19 million total medical members, down 2.4% year over year. 
    • “The company’s medical loss ratio was 82.3% in the second quarter, compared to 81.2 percent during the same period last year.”
  • and
    • “EncircleRx, a program helping employers control the cost of GLP-1 drugs for weight-loss, has reached 2 million enrollees in its first six months. 
    • “Cigna launched the program in March, which it called the “first-ever” GLP-1 management program with a financial guarantee for health plans. 
    • “GLP-1 medications approved for weight loss include Wegovy, Saxenda and Zepbound. These drugs can cost upward of $1,000 a month. On an Aug. 1 call with investors, Cigna CEO David Cordani said GLP-1s are expected to be the No.1 driver of pharmacy benefit trends for plans of all sizes in 2024. 
    • “Eric Palmer, president and CEO of Evernorth, Cigna’s health services business, told investors the program is “growing nicely,” reaching 2 million enrollees.” 
  • Healthcare Dive adds,
    • “Cigna’s chief executive is pledging to be more aggressive in defending its pharmacy benefit manager amid mounting public criticism of the drug middlemen — and as its PBM, Express Scripts, continues to drive soaring revenue for the insurance giant.
    • “That includes heavier lobbying in Washington, sponsoring more research into the value of PBMs and working more with independent pharmacists, which have been some of PBMs’ loudest critics, CEO David Cordani told investors on a Thursday morning call to discuss the payer’s second quarter results.
  • Beckers Payer Issues points out,
    • “UnitedHealthcare will launch its national gold-card program on Oct. 1. 
    • “The program will reward contracted provider groups that “consistently adhere to evidence-based care guidelines,” according to an Aug. 1 policy update from UnitedHealthcare. The program will apply to all UnitedHealthcare commercial, individual exchange, Medicare Advantage and community plans. 
    • “The payer said that details on how to determine whether a provider group has qualified for the program will be published Sept. 1. Additional details will be available on UHCprovider.com.”
  • Per BioPharma Dive,
    • “After a slow start, the launch of Biogen’s prized drug for Alzheimer’s disease is picking up, which has given company leadership more confidence that it can both drive growth and compete with a rival medicine from Eli Lilly.
    • “Sales of Biogen’s drug, Leqembi, were $40 million between April and June, more than double the total seen across the first three months of this year. On a Thursday call with reporters, CEO Chris Viehbacher said north of 5,000 people in the U.S. are taking Leqembi, though it’s “hard to know” the exact number because of how the drug is administered. Patient registries have also become “confusing” and less useful sources of information, according to Viehbacher.
    • “We’re pretty convinced Leqembi is on the right path now,” he said.”
  • and
    • “Shares of Moderna fell nearly 20% on Thursday after the company lowered its 2024 financial forecasts amid slowing sales and growing competition for its vaccines. 
    • “Alongside its second-quarter earnings report, Moderna cut its projected product sales outlook this year from $4 billion to an expected $3 billion to $3.5 billion. The biotechnology company cited multiple reasons for lowering its estimate, from expectations of lower COVID-19 vaccine sales in Europe, to deferred government contracts and tough competition from other vaccine developers. The announcement triggered a stock sell-off and “raises doubt about hitting profitability and cash burn goals,” Jefferies analyst Michael Yee wrote in a research note Thursday.
    • “Moderna rose to prominence through the development of a COVID-19 shot that was among one of the industry’s most lucrative products a few years ago. But sales have plummeted since, as COVID-19 has transitioned to an endemic disease, more business is taking place in the commercial market and massive bulk government contracts have been harder to secure.” 
  • Per Beckers Hospital Review,
    • “An examination of hospital rankings from CMS and U.S. News & World Report suggests a notable overlap in organizations recognized for high performance.
    • “All but three of U.S. News‘ 2024-25 Honor Roll hospitals also earned top marks in CMS’ Overall Hospital Star Ratings released July 31.”
    • “While the results are closely aligned, CMS and U.S. News use different methodologies and criteria for their evaluations. CMS assessed more than 4,600 hospitals nationwide on 46 hospital quality measures, assigning 381 hospitals with five stars. Measures are divided into five categories: safety of care, mortality, patient experience, readmission rates, and timely and effective care. Data reporting periods range from July 2019 to April 2022, depending on the measure.” 
  • Modern Healthcare reports,
    • “Many hospitals have struggled to offer safe and effective care in the years since the COVID-19 pandemic turned their operations upside down.
    • “The Centers for Medicare and Medicaid Services’ 2024 hospital star ratings, released Wednesday, showed more hospitals than last year performed poorly. That may be, in part, because the data submitted by hospitals was from April 2019 through March 2023 and excluded facilities’ performance on quality metrics from the first half of 2020.
    • “Last year’s ratings were based on data from 2018 through the beginning of 2022. In effect then, the data determining 2024 performance reflected more of the heart of the pandemic.
    • “Across peer groups and facility types, nearly 10% of the 2,834 hospitals CMS rated received one star, 21% got two stars, 29% got three stars, 27% earned four stars and 13% got five stars.”
  • and
    • “Jefferson Health and Lehigh Valley Health Network completed a merger Thursday that creates a $15 billion nonprofit health system serving Pennsylvania and New Jersey.
    • “Jefferson Health CEO Dr. Joseph Cacchione, who is leading the new enterprise, said the provider has its sights set on integrating the organization’s 32 hospitals and more than 700 locations over the next few years. The company will operate under the Jefferson Health brand.”
  • Healthcare Dive adds,
    • “Community Health Systems plans to sell its three hospitals in Pennsylvania to nonprofit health system WoodBridge Healthcare for $120 million, exiting the state altogether, the system said Tuesday. 
    • “The deal is expected to close in the fourth quarter, pending regulatory reviews.
    • “During CHS’ second quarter earnings call last week, CFO Kevin Hammons said the company hoped to sell upwards of $1 billion in assets this year to help pay down its debts. This transaction is part of that divestiture plan, CHS said in a statement.”

Monday Roundup

David Ermer–CDC, Medicare, Mental health care, Obesity, OPM, SCOTUS, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Kiplinger Private Finance reminds us,
    • “Beginning in 2025, people with Part D plans won’t have to pay more than $2,000 in out-of-pocket costs, thanks to a provision in the Inflation Reduction Act of 2022. The $2,000 cap will be indexed to the growth in per capita Part D costs, so it may rise each year after 2025. Part D enrollees will also have the option of spreading out their out-of-pocket costs over the year rather than face high out-of-pocket costs in any given month.”
  • The Part D EGWP benefit package is so generous for 2025 that it should sell itself. Given this juicy carrot, there is no reason why OPM chose to resort to the stick – prohibiting Part D EGBP opt outs from receiving the regular PSHBP prescription drug benefits. Hopefully, OPM will switch back to the carrot in the final PSHBP supplemental rule.
  • Govexec points out,
    • “Only 7% of the full-time civil service was under the age of 30 at the end of fiscal 2022 compared with 20% of the overall U.S. labor force, according to the Partnership. This shaky pipeline of young workers could exacerbate staffing shortages, as a 2022 White House document concluded that 30% of the federal workforce would be eligible to retire over the next five years.
    • “The underrepresentation also means that federal agencies could miss out on younger perspectives and talent, particularly from Generation Z (individuals born in the late ‘90s and early ‘00s). Gaurav Gupta — managing director of the consulting firm Kotter, which researches workforce transformation — argues that workplaces could greatly benefit from younger workers who have a “much higher propensity for change.” 
    • The article discusses approaches for attracting more Gen Zers to federal government service.
  • MedTech Dive reports,
    • “The Food and Drug Administration has approved Guardant Health’s Shield blood test as a primary screening option for colorectal cancer in average-risk adults age 45 and older, the company said Monday.
    • “Guardant is positioning the test, which can be completed during a routine doctor visit, as a more pleasant and convenient alternative to colonoscopy or stool-based tests that will encourage more people to undergo colorectal cancer screening.
    • “Shield can address a number of unscreened individuals (with a blood draw) for those not willing or unable to perform a colonoscopy or take a stool test,” Leerink Partners analyst Puneet Souda wrote in a report to clients. Still, Souda expects colonoscopy to remain the first-line screening choice of physicians based on clinical evidence, followed by Exact Sciences’ Cologuard stool test.”
  • Supreme Court journalist Amy L. Howe shares the Supreme Court’s October and November 2023 oral argument calendars. None of the scheduled cases directly impacts health plans as such.

From the public health and medical research front,

  • NBC News reports,
    • “The number of measles cases recorded this year is more than triple the total from all of last year — with five months still to go.
    • “According to data released Friday by the Centers for Disease Control and Prevention, 188 cases have been reported in 26 states and Washington, D.C. No deaths have been reported, but 93 people have been hospitalized — mostly children under 5 years old.
    • “The U.S. has seen 13 measles outbreaks this year, the largest of which took off at a migrant shelter in Chicago in March and was linked to more than 60 cases.
    • “This month, measles cases have been reported in Massachusetts, Michigan, Minnesota, New Hampshire, New York, Oregon and Vermont. Massachusetts’ case was the first in the state since early 2020.” * * *
    • “Experts attribute this year’s uptick to two main factors: declining vaccination rates in the U.S. and a rise in measles cases worldwide.
    • “Around 85% of the people who got measles this year were either unvaccinated or had an unknown vaccination status, according to the CDC. Many of the cases have been linked to international travel, meaning the disease was brought into the U.S. by travelers who were infected in other countries.”
  • STAT News tells us,
    • “With the number of U.S. dairy herds infected with H5N1 bird flu rising almost daily, fears are growing that the dangerous virus cannot be driven out of this species. That belief is amplifying calls for the development of flu shots for cows.
    • “Multiple animal vaccine manufacturers are reportedly at work trying to develop such products. And the U.S. Department of Agriculture is eagerly encouraging the effort, detailing in a notice last week what kinds of evidence would be needed to win licensing approval for cow vaccines.
    • “But a number of scientists question whether investing too heavily in this strategy is a wise approach at this point, given that there remain many outstanding questions about whether vaccinating cows would be an effective way of stopping spread of the virus in cattle in the first place. Some wonder whether farmers will be willing to absorb the costs of vaccines to prevent an infection they don’t currently view as a serious threat to their operations, or whether they would agree to the stringent post-vaccination surveillance that must go hand-in-glove with any attempt to use vaccines to solve this vexing problem.” * * *
    • “David Swayne, an avian influenza expert who worked for the USDA for nearly 30 years and is now a private consultant, agreed that vaccination of cows would have to be done as part of a more multifaceted response. “It’s not just about injecting a vaccine,” he said. “You need to then follow up to look serologically, and then you also need to follow up to make sure there’s no virus by testing, let’s say, bulk milk or something like that. Surveillance is really a critical part of any kind of vaccination program for a severe disease like [highly pathogenic avian influenza.]”
    • “Swayne acknowledged the concerns about the unanswered questions about how H5N1 is spreading in cows, but he said vaccine manufacturers should be working on vaccines while researchers are seeking those answers. Vaccines may be a necessary tool for controlling this disease in the future. “Instead of waiting until you answer all the questions on pathogenesis, it’s good to go ahead and start working on those vaccines now, so that when you get to the end, and you have all your answers, you’ve got the vaccines ready for that final step,” he said.”
  • Beckers Hospital Review lets us know,
    • “The FDA is warning healthcare providers of dosing errors associated with compounded versions of semaglutide, the active ingredient in Ozempic, Rybelsus and Wegovy.
    • “The agency has received reports of hospitalizations and adverse events tied to the issue, including gastrointestinal issues, fainting, headache, dehydration and acute pancreatitis, according to a July 26 update. 
    • “Most adverse events occurred when patients self-administered incorrect doses of weight loss drugs from multiple-dose vials, sometimes taking five to 20 times the intended amount. Several reports also involved clinicians miscalculating doses, resulting in patients receiving five to 10 times more than the intended dose. 
    • “The agency said patients’ inexperience with self-injections and confusion over different measurement units may have contributed to the errors. 
    • “FDA encourages health care providers and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe,” the agency said in the update. “Additionally, health care providers should be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available.”
    • “Learn more here.”
  • At this link, “KFF Examines the Latest Data on Calls, Texts, and Chats to the 988 National Suicide and Crisis Hotline, Two Years After Its Launch.” 

From the U.S. healthcare business front,

  • Per its website,
    • “”Community Health Systems (CHS) operates 71 acute-care hospitals and more than 1,000 other sites of care, including physician practices, urgent care centers, freestanding emergency departments, occupational medicine clinics, imaging centers, cancer centers and ambulatory surgery centers.”
  • Healthcare Dive adds,
    • “Community Health Systems grew same-store surgical volumes and outpatient volumes in the second quarter, helping the Franklin, Tennessee-based system trim losses for the second consecutive quarter. However, the system still posted a net loss of $13 million for the quarter.
    • “CHS attributed its improved financial position to an early “extinguishment” of debt, reduced expenses for contract labor and increased reimbursement rates.
    • “On an earnings call Thursday, CEO Tim Hingtgen said the results speak to CHS’ solid fundamentals, and said he believes the company can continue to improve in subsequent quarters. CHS raised the midpoint of its full-year EBITDA guidance by $10 million in light of the results.”
  • Per BioPharma Dive,
    • “An experimental heart drug from biotechnology company NewAmsterdam Pharma met its main goal in the first of several Phase 3 trials, but the results fell short of investor and analyst expectations.
    • “In the trial, people with an inherited condition called heterozygous familial hypercholesterolemia who received the drug alongside other medicines saw their levels of LDL, or “bad,” cholesterol fall by 36% after three months, when adjusted for placebo, and by 41% after one year. The drug, obicetrapib, reduced other markers of heart disease while its safety was “comparable to placebo,” the company said.
    • “On a conference call, NewAmsterdam CEO Michael Davidson said the results raise the company’s confidence in other ongoing studies. But shares fell by as much as one-third in premarket trading before opening down 4% Monday morning, as investors had anticipated more powerful cholesterol-lowering effects.”
  • American Hospital Association News points out,
    • “A fact sheet released July 29 by the Coalition to Strengthen America’s Healthcare features analysis from KNG Health Consulting that shows nearly half of all hospital emergency department visits occur after-hours (between 5 p.m. and 8 a.m.), when patient care options are limited. The analysis found that children are particularly more likely to receive care at an ED outside of normal business hours. It also found that of the 136 million ED visits in 2021, 18.1 million were in rural areas, and that 34.3 million visits that year were trauma related. The AHA is a founding member of the Coalition.”
  • That means over 100 million of the ED visits were not trauma related. What’s up with that?
  • Per Fierce Pharma,
    • “A month after a CDC panel narrowed its recommendations for who should receive vaccines to protect against respiratory syncytial virus (RSV), Airfinity has put numbers to the impact, reducing the projected market value in the United States by 64% by the end of the decade.
    • “The London-based healthcare analytics company has sliced the RSV market value for seniors in the US from $4.7 billion to $1.7 billion in 2030.” * * *
    • “Much still has to be decided related to RSV vaccines. Airfinity pointed out that “future dosing recommendations could change as long-term efficacy and safety data emerge.” With recommendations for a booster every two to three years, the U.S. market could increase in annual value to between $5.2 billion and $6.6 billion, Airfinity projects.”
  • The Washington Post reports,
    • “Almost half the counties in the United States lack a single cardiologist, according to a new study that puts the decades-long rural health-care crisis into sharp relief.
    • “Researchers at Brigham and Women’s Hospital in Boston looked at all 3,143 U.S. counties and found that just over 46 percent had no cardiologist, a finding senior author Haider J. Warraich called “truly shocking.”
    • “Compounding the problem, researchers discovered that risk factors for cardiovascular disease such as smoking, diabetes, obesity and high blood pressure “were actually more prevalent in the counties that did not have a cardiologist,” said Warraich, who spent several months in 2019 moonlighting as the only cardiologist in rural Randolph County, N.C.” * * *
    • “Alexander Razavi, a cardiology fellow at Emory University School of Medicine in Atlanta, said cardiologists may need to look beyond telemedicine to additional measures to reach rural communities. Cardiology practices that serve these areas, he said, might consider extending their hours or creating mobile examination units.
    • “We need to invest and provide resources to these communities,” Razavi said.”
  • Consumer Reports, writing in the Washington Post, lets us know how to know if claims made by health products are real or just hype. Check it out.


Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Medical Economics alerts us,
    • “The hot seat in Washington, D.C., could get hotter for pharmacy benefit managers (PBMs) when the Federal Trade Commission (FTC) meets next week to discuss its recent report on the drug price middlemen.
    • “Meanwhile, a consortium of pharmacy groups is demanding federal lawmakers pass reforms they say are needed to regain control of the pharmaceutical market. A PBM trade group countered that legislators need a balanced and accurate discussion, not just repetition of claims of Big Pharma, which stands to benefit if PBMs lose their price bargaining power.
    • “As public discourse about PBMs at times rises to a clamor, the FTC announced its Aug. 1 open meeting will include a presentation on the Commission’s Interim Report on Pharmacy Benefit Managers (PBMs).”
  • FEHBlog note — PBMs do a more than negotiate prices with drug manufacturers and wholesalers. For example, PBMs also seamlessly process drug claims for consumers.  
  • Beckers Hospital CFO Report tells us,
    • “The U.S. economy saw a 2.8% increase in gross domestic product in the second quarter of 2024, reflecting a spike in consumer spending, nonresidential fixed investment and private inventory investment. 
    • “The first quarter saw GDP grow only 1.4%, according to the Bureau of Economic Analysis.
    • “Consumer spending also increased in goods and services. Healthcare, utilities, recreation services, and housing led service contributors. Motor vehicles and parts, furnishing and durable household equipment, gasoline and recreational goods led goods contributors.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention (“CDC”) announced today,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity has increased in most areas.
    • “COVID-19
      • “Most areas of the country are experiencing consistent increases in COVID-19 activity. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are increasing, particularly among adults 65+. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • The University of Minnesota CIDRAP adds,
    • “Nationally, wastewater detections of SARS-CoV-2 have been at the high level over the past few weeks, with the highest levels in Western states over the summer months. However, the CDC’s latest data show though detections in the West are still the highest in the nation, the level declined in the most recent reporting week.
    • “Wastewater detections are still rising steadily in the South. In the Midwest and Northeast, detections are still increasing, but at a slower pace.”
  • STAT News points out,
    • “The number of confirmed human infections with the bird flu virus associated with the ongoing outbreak in dairy cattle has risen to 13, the Centers for Disease Control and Prevention announced Thursday, as it confirmed three additional cases in Colorado. They are currently designated simply as H5 and not H5N1 because CDC labs are still working on typing the neuraminidase, the N number in the virus’ name, STAT’s Helen Branswell reports.
    • “The cases — one of which Colorado had previously announced as a “presumptive positive” — are in people who were culling infected poultry on a farm in the state. Genetic analysis of the virus in that poultry outbreak shows that it is similar to the virus circulating in cows; it’s believed this is one of several instances where H5N1 in cow herds has spilled over into nearby poultry operations. Of the 13 human cases, 10 have been detected in Colorado, which also has the highest number of reported infected dairy herds — 51, according to the state’s Department of Agriculture. Michigan and Texas have reported two and one human case, respectively.”
  • The Detroit Free Press reports,
    • “Liverwurst and several other deli meat products produced by Boar’s Head Provisions Co., Inc., based in Jarratt, Virginia, are being recalled because they may be contaminated with the Listeria monocytogenes bacteria, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) on Friday announced.
    • “Additional deli meat products produced on the same line and same day as the liverwurst are also being recalled because of potential listeria contamination.
    • “In total, more than 207,000 pounds of products are being recalled.
    • “The FSIS is concerned because some products may be in consumers’ refrigerators and in retail deli cases.”
  • MedPage Today discusses issues with the CDC’s bird flu virus vaccine.
  • Mercer Consulting explains why GLP-1 drug dislocation calls for a holistic approach to weight-loss.
  • U.S. News and World Report informs us,
    • “Cancer growth can be fueled by flecks of ancient viral DNA lodged into the genetics of modern humans, a new study says.
    • “Overall, about 8% of the human genome is made of bits of DNA left behind by viruses that infected our primate ancestors, researchers say.
    • “Called “endogenous retroviruses,” these DNA fragments have long been considered harmless junk littering the modern human genetic profile, researchers said.
    • “But new research shows that when reawakened, these ancient viral strands can help cancer survive and thrive, researchers reported July 17 in the journal Science Advances.
    • “What’s more, shutting up these viral voices from the past can make cancer treatments more effective, researchers found.
    • “Our study shows that diseases today can be significantly influenced by these ancient viral infections that until recently very few researchers were paying attention to,” said senior researcher Edward Chuong. He’s an assistant professor of molecular, cellular and developmental biology at the University of Colorado, Boulder’s BioFrontiers Institute.”

From the U.S. healthcare business front,

  • The Wall Street Journal looks at the drug shortage problem from the perspective of a courageous American who invested in a failing Amoxicillin plant located in Bristol, TN.
    • “A cavernous factory in northeastern Tennessee, by the Virginia border, is one of the last in the country that makes a vitally important medicine.
    • “Each day the USAntibiotics plant churns out a million doses of the crucial antibiotic amoxicillin that promise to cure Americans of everything from earaches to pneumonia—and ease a pressing shortage for children.
    • “But the plant’s prospects are dim. It can’t charge enough to cover overhead, because competitors sell their wares at bargain prices. USAntibiotics isn’t close to breaking even.
    • “It’s not for lack of trying,” said Rick Jackson, a health-staffing businessman who rescued the factory from near bankruptcy two years ago and has poured more than $38 million into purchasing and refurbishing it.
    • “The generic drug business has become a hostile environment for American companies. Prices for the often-critical medicines have dropped so low that it has become difficult for U.S. manufacturers to compete with companies overseas.”  * * *
    • “Jackson is holding out hope the federal government will help the plant. But if it doesn’t in the next year and a half, he said would shut the factory down.
    • “It’s not a failure yet,” Jackson said. “If there is a way to do it, we’ll figure it out.”
    • FEHBlog note – Hopefully the front-page WSJ article will help generate outside investment.
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Friday raised its forecast for revenue and profit per share this year after a second quarter in which sales of its older products and new drugs surpassed analyst expectations.
    • “The “beat and raise” followed similarly strong earnings reports this week from AstraZeneca, Roche, Sanofi and AbbVie, all of which upped either their revenue or profit estimates for 2024. Shares in Bristol Myers rose by nearly 9% in Friday morning trading on the news.
    • “Between April and June, Bristol Myers reported earning $12.2 billion in sales, 6% higher than Wall Street consensus forecasts. Second quarter earnings per share were $2.07 on an adjusted basis, 27% higher than estimated, according to Leerink Partners analysts.”Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies.[1] The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.
  • Cardiovascular Business reports,
    • “Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies. The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • “A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • “If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.”
    • FEHBlog note: Bravo.