Monday Roundup

COVID-19

Monday Roundup

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) launched a new national campaign today to inform the public about common respiratory viruses and available vaccines. The campaign, Risk Less. Do More., aims to increase awareness of vaccines that reduce serious illness from influenza (flu), COVID-19, and respiratory syncytial virus (RSV) in high-risk populations and to limit the spread of these viruses among all Americans.” * * *
    • “For more information on the Risk Less. Do More. campaign, please visit RiskLessDoMore.hhs.gov.”
    • “For more information about respiratory illnesses, please visit cdc.gov/RiskLessDoMore.”
  • The American Hospital Association News lets us know,
    • “The Organ Donation and Transplantation Alliance has created new resources for health care providers to encourage more organ donation and transplants. It has launched an educational guide to enhance collaboration between organ procurement organizations, transplant centers and hospitals. The Alliance last week hosted a workshop complementing the guide launch. An on-demand learning pathway video and other supporting materials will be available in September.”
  • Federal News Network tells us,
    • “The Biden administration says federal agencies are getting rid of office space they no longer need, and will shed millions of square feet in the coming years, now that many federal employees are on a hybrid schedule of in-office and work-from-home days.
    • “The Office of Management and Budget, in a sweeping report released earlier this month, said telework-eligible federal employees are working in their offices about 60% of the time.
    • “That hybrid schedule allows agencies to reevaluate their office space needs, and shed excess leased and government-owned real estate.
    • “While agencies reach more durable, long-term decisions about their telework and work environment posture, they are also considering the impacts of these changes on their real property portfolios,” OMB wrote. “Agencies have undertaken considerable work to dispose of unneeded property, reduce costs, and improve overall utilization of real estate.”

From the public health and medical research front,

  • The New York Times reports,
    • “In the study, which was published Monday in the journal Nature Medicine, researchers transformed deep brain stimulation — an established treatment for Parkinson’s — into a personalized therapy that tailored the amount of electrical stimulation to each patient’s individual symptoms.
    • “The researchers found that for Mr. Connolly and the three other participants [with Parkinson’s Disease], the individualized approach, called adaptive deep brain stimulation, cut in half the time they experienced their most bothersome symptom.
    • “Mr. Connolly, now 48 and still skateboarding as much as his symptoms allow, said he noticed the difference “instantly.” He said the personalization gave him longer stretches of “feeling good and having that get-up-and-go.”
    • “The study also found that in most cases, patients’ perceived quality of life improved. “That’s very important,” said Dr. Sameer Sheth, a professor of neurosurgery at Baylor College of Medicine who was not involved in the research.
    • “Although the study was small, it represents the strides being made in using brain implants and artificial intelligence to personalize treatment for neurological and psychiatric disorders — essentially developing pacemakers for the brain.”
  • STAT News points out,
    • “The distress from receiving a cancer diagnosis is something that clinicians widely anticipate in patients, but suffering often doesn’t just afflict the patient. It can blanket an entire household, burdening spouses and other family members with stress and anxiety and the exhausting routine of treating a life-threatening disease.
    • “But while standards exist for assessing and managing distress in patients, it’s often “hidden” in family members, sometimes with devastating consequences, said Weiva Sieh, an epidemiologist at MD Anderson Cancer Center. In a study published in JAMA Oncology on Thursday, spouses of cancer patients were found to be at significantly higher risk of suicide attempt and death compared to those married to people without cancer.  
    • “Psychosocial distress in cancer patients themselves are better anticipated, widely known, and accepted,” said Sieh, who did not work on the study but wrote an accompanying editorial in JAMA Oncology. “This problem is not extremely well recognized. Fortunately, mental health is often treatable. It’s just a question of recognizing it.”
  • MedPage Today notes,
    • “Primary care practitioners (PCPs) provided the majority of prescriptions for HIV preexposure prophylaxis (PrEP) in the U.S., but the odds of patients filling a PrEP prescription were better when it came from an infectious disease (ID) specialist, according to a cross-sectional study.”
  • Fierce Healthcare asserts that “Insurers push ‘food is medicine’ interventions but rarely weigh in on ultra-processed food.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Rochester, Minn.-based Mayo Clinic reported an operating income of $449 million (8.9% margin) in the second quarter, a substantial improvement on the $300 million operating gain (5.9% margin) it posted in the same period last year.
    • “Second-quarter revenue increased 12.1% year over year to $5 billion while expenses grew by 9.4% to $4.6 billion, according to financial documents published Aug. 19. Solid patient volumes and increased donor contributions drove revenue growth during the second quarter. 
    • “Labor costs increased 7% year over year to $2.6 billion while supplies and services expenses rose 13.3% to $1.6 billion. The 7% increase in labor costs — which accounted for 56.9% of total second-quarter expenses — is attributed to staff growth to accommodate higher volumes and a 4% annual salary increase for all allied health staff.
    • “After factoring in nonoperating items, including philanthropy and returns from investments, Mayo reported a net income of $613 million in the second quarter, compared to $547 million in the second quarter of 2023.” 
  • Healthcare Dive adds,
    • “Bankruptcy filings in the healthcare sector have slowed so far in 2024 after spiking last year, according to a report by healthcare restructuring advisory firm Gibbins Advisors.
    • “This year is on track to see 58 filings by healthcare companies with at least $10 million in liabilities, compared with 79 cases in 2023.
    • “But the decline doesn’t necessarily mean the financial headwinds driving bankruptcies have lessened, according to the advisory firm. Restructuring could be taking place outside of courts, and case volumes might increase later this year, Clare Moylan, principal at Gibbins Advisors, said in a statement.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb’s highly anticipated schizophrenia drug KarXT is fast approaching a September deadline for the Food and Drug Administration to decide on approval. Yet competition already looms for a market that’s estimated to soon be worth billions of dollars.
    • “KarXT, a so-called muscarinic agonist, may become the first new kind of schizophrenia drug in decades. Close behind it is AbbVie’s emraclidine, which works in a similar fashion.
    • “People with schizophrenia experience a broad range of symptoms, from hallucinations and delusions to cognitive impairments and social withdrawal. Clinical testing has shown that, like KarXT, emraclidine, which AbbVie acquired from Cerevel Therapeutics in a multibillion-dollar deal, is effective at controlling symptoms without the debilitating side effects or drawbacks of traditional antipsychotics, which cause almost three-quarters of patients to abandon treatment.
    • “But experts say once-daily dosing versus twice-daily treatment, and a potentially more gut-friendly formulation, may give emraclidine an edge over KarXT, which Bristol Myers Squibb acquired in a $14 billion acquisition of Karuna Therapeutics.”
  • MedCity News considers “Why Primary Care Physicians Are Reluctant to Join Value-Based Care.”

Weekend Update

David Ermer–CMS, Congress, COVID-19, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The House of Representatives and the Senate remain on their August recess until September 9.
  • Roll Call reported on August 14,
    • “New Jersey Democratic Gov. Phil Murphy intends to appoint his former chief of staff, George Helmy, to fill the Senate seat that Sen. Bob Menendez will vacate next week, multiple New Jersey media outlets reported Wednesday evening, citing sources.
    • “Helmy, who has most recently worked as executive vice president and head of external affairs for RWJBarnabas Health, will serve until the end of the 118th Congress. The seat for the full term starting in January will be filled by the winner of the November election between Rep. Andy Kim, the Democratic nominee, and Republican Curtis Bashaw.”
  • On August 16, the Congressional Budget Office released to the House Oversight and Accountability Committee a report on H.R. 7868, the FEHB Protection Act.
    • The problematic aspect of the bill is that it focuses on tightening up oversight of family member eligibility when OPM does not give FEHB plans the information to confirm that plan enrollees are paying the proper premium or any premium for their coverage, which creates a yawning gap in internal controls. OPM can cure this problem by implementing the HIPAA 820 enrollment roster transaction.

From the public health and medical research front,

  • Fortune Well identifies where COVID has been spiking in the U.S. this summer.
    • “In the four-week period ended Aug. 10, the national test positivity rate was 15.6%. During that time, five states in the South-Central U.S. saw the highest test positivity, 21%. These states collectively make up the CDC’s Region 6:
      • Arkansas
      • Louisiana
      • New Mexico
      • Oklahoma
      • Texas
    • “States in Region 9—Arizona, California, Hawaii, and Nevada—had the next-highest four-week positivity rate, 18.8%. Ten other states across two Midwestern regions were also above the national average. No state—as well as the District of Columbia, Puerto Rico, and the Virgin Islands—had a positivity rate below 10%.”
  • The Washington Post lets us know,
    • “The Centers for Disease Control and Prevention is warning clinicians to be on the lookout for a viral disease that is spread by small flies and some types of mosquitoes and that causes sudden fever, severe headaches and chills.
    • “Cases of Oropouche virus disease have been climbing in South America and the Caribbean in the past two years and turned deadly for the first time this year.
    • “The CDC advisory issued Friday recommends that pregnant people reconsider nonessential travel to Cuba, which reported its first confirmed case in June.”
  • and
    • “Though appendectomies have been the gold standard of care since before the turn of the 20th century, doctors have been treating appendicitis with antibiotics since the 1950s, as soon as they became available — a “dark secret” in the surgery world, says David R. Flum, professor of surgery and director of the Surgical Outcomes Research Center at the University of Washington. A 1959 paper detailed the use of antibiotics to treat nearly 500 people (a mix of adults and children) with appendicitis. They were — and still are — often used in people whose appendicitis is so advanced that surgery risks spreading the infection further. The military relied on antibiotics for service members who got appendicitis while in inaccessible locations, like submarines.
    • “But the treatment didn’t get wider attention until the late 1990s and early 2000s, Flum says, when researchers began to collect data on how often antibiotics don’t work and found that failure was not as common as they thought.
    • “Then came two large, randomized trials in adults. In the first, published in 2015, 257 adults received an antibiotic treatment. Seventy of those patients, or 27 percent, had to have an appendectomy within one year. But the rest were fine.
    • “A second, larger study of 1,552 adults had similar results: Twenty-nine percent of the 776 people who received antibiotics underwent surgery within 90 days; 4 percent of people in the antibiotics group had serious adverse events, compared with 3 percent in the appendectomy group. The New England Journal of Medicine published the results in 2020. The same year, the American College of Surgeons added nonoperative management as an option in its guidelines for treating appendicitis.
    • “It wasn’t a slam dunk, but the studies showed that antibiotics could be a good choice.”
  • The New York Times discusses “The Painkiller Used for Just About Anything. In huge numbers, older people are taking gabapentin for a variety of conditions, including itching, alcohol dependence and sciatica.”
    • “It’s crazy how many [off label] indications it’s used for,” said Dr. Michael Steinman, a geriatrician at the University of California, San Francisco, and a co-director of the U.S. Deprescribing Research Network. “It’s become a we-don’t-know-what-else-to-do drug.”
    • “What has fueled this multipurpose popularity? “The history of gabapentin is really a history of uses getting ahead of the evidence,” said Dr. Joseph Ross, an internist and health policy researcher at Yale School of Medicine.” * * *
    • Dr. Steinman called it a “sticky” drug. He was an author of a 2022 study on older adults who were prescribed gabapentin after surgery, most commonly hip and knee replacements. One in five refilled the prescription more than three months later, when “presumably their surgical pain has long since resolved,” he said.
    • As older patients seek to find relief from chronic pain, “we don’t have a lot of great options,” Dr. Steinman said of health care providers. Prescribers try to avoid opioids, and nonsteroidal anti-inflammatories like ibuprofen are recommended only for short-term use.
    • Some find relief from medical cannabis, topical medications like creams and patches, and non-pharmacological approaches such as acupuncture, therapeutic massage and exercise.
    • “Often the single best thing I can do for patients with pain is to get them to physical therapy,” Dr. Steinman added.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Orlando Health has offered to buy Steward Health Care’s three “Space Coast” Florida properties, including three hospitals and a medical practice, for $439 million, according to a court document filed Wednesday.
    • “Bankrupt Steward Health Care and Orlando Health have entered into a binding asset purchase agreement to sell Rockledge Regional Medical Center, Melbourne Regional Medical Center, Sebastian River Medical Center. The proposed deal also includes Steward Medical Group Practices in East Central Florida.
    • “According to the court document, filed in U.S. bankruptcy court in the southern district of Texas, Steward designated Orlando Health a “stalking horse bidder,” which is the first to negotiate a purchase agreement with a debtor in bankruptcy. The bidder sets a minimum price and protects the debtor from low bids.
    • “The purchase agreement for Steward’s northern Florida assets is for $439.42 million in cash, according to the court document.
    • “Orlando Health’s bid will be subject to higher or better-qualified bids received by August 26, at which time a bankruptcy court-approved auction may occur, according to a press release from Steward Health Care.”
  • The Wall Street Journal adds
    • “Steward Health Care System was in such dire straits before its bankruptcy that its hospital administrators scrounged each week to find cash and supplies to keep their facilities running. 
    • “While it was losing hundreds of millions of dollars a year, Steward paid at least $250 million to its chief executive officer, Dr. Ralph de la Torre, and to his other companies during the four years he was the hospital chain’s majority owner.
    • “Steward filed for bankruptcy in May, becoming one of the biggest hospital failures in decades.” * * *
    • “The Senate Committee on Health, Education, Labor and Pensions in a bipartisan vote authorized an investigation and subpoenaed de la Torre to testify at a Sept. 12 hearing.”

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.”

Tuesday Tidbits

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Roundup

David Ermer–CDC, Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports,
    • “A new initiative from the Biden administration aims to quell a varied series of consumer “headaches” by reducing their extraneous time and processes, including for federal employees trying to file health insurance claims.
    • “Detailed in a memo Monday, the “Time Is Money” initiative would touch upon processes across multiple industries that the White House deemed deliberate, time-consuming and burdensome for consumers, such as procuring refunds, canceling subscriptions and filing insurance claims.”  * * *
    • “The memo also outlined plans by the Office of Personnel Management to make it easier for employees on the Federal Employees Health Benefits and Postal Service Health Benefits plans to submit out-of-network claims online, would provide them with better information about which providers are in-network and how to appeal claim denials. 
    • “The proposed OPM requirements are part of a larger proposal within the initiative that would focus on streamlining the insurance claims process, with the Labor and Health and Human Services secretaries calling on insurance carriers to simplify their claims process and move it online, while also improving information access and call center times.” * * *
    • OPM officials were unable to respond by press time to questions about how and when the requirements will be rolled out. 
  • The FEHBlog doubts that many people submit health insurance claims. Dental claims may be a different story.
  • Here’s a link to an HHS and Labor Secretary message to health insurer CEOs about the new initiative.
  • Federal News Network points out six federal workforce bills pending in Congress that are worth tracking.

From the public health and medical research front,

  • STAT News lets us know,
    • “The Centers for Disease Control and Prevention issued a new risk assessment of the H5N1 bird flu virus circulating in dairy cows on Friday, increasing slightly its estimate of the chance it poses of triggering a pandemic.
    • “The new assessment, developed using the CDC’s influenza risk assessment tool or IRAT, gauged the risk the virus might someday cause a pandemic at 5.79, up from a previous score of 5.12 from an assessment of a related virus conducted in April 2023. Both numbers are within what the CDC tool terms a “moderate” risk of 4.0 to 7.9. Some swine influenza viruses and the H7N9 bird flu virus have scored higher than this version of H5N1 using the IRAT process.” * * *
    • “Vivien Dugan, director of the CDC’s influenza division, cautioned that the IRAT is a tool for government planning purposes, and isn’t meant to gauge the risk for the public. The agency still characterizes the risk H5N1 poses to the general public as low.”
  • Per an NIH press release,
    • “A National Institutes of Health (NIH)-supported study has found that routine lab tests may not be useful in making a long COVID diagnosis for people who have symptoms of the condition. The study, part of NIH’s Researching COVID to Enhance Recovery (NIH RECOVER) Initiative and published in the Annals of Internal Medicine, highlights how challenging it can be to identify and diagnose a novel illness such as long COVID.” * * *
    • “Future work will use RECOVER’s biobank of cohort samples such as blood and spinal fluid, to develop more novel laboratory-based tests that help us better understand the pathophysiology of long COVID,” said Kristine Erlandson, M.D., professor of medicine-infectious disease at the University of Colorado Anschutz Medical Campus, Aurora.”
  • BioPharma Dive tells us,
    • “Pfizer on Monday said its RSV vaccine Abrysvo led to strong immune responses in immunocompromised adults given the shot in a late-stage study.
    • “The results came from a sub-study of a Pfizer-run Phase 3 trial testing two doses of Abrysvo in adults at risk of severe lower respiratory tract disease associated with respiratory syncytial virus, or RSV. Vaccination was well-tolerated, Pfizer said, and led to a “strong neutralizing response” against RSV subtypes A and B.
    • “The data add to evidence of the effectiveness of Abrysvo, which faces competition from GSK’s rival vaccine Arexvy and Moderna’s mResvia, which gained Food and Drug Administration approval in May.”
  • Beckers Hospital Review informs us,
    • “Labels for GLP-1 medications, like Ozempic and Mounjaro, might see more approved uses as researchers study the drugs’ effects on sleep apnea, dementia and other health issues. Meanwhile, oncologists are looking at a GLP-1 role in cancer care.
    • “Several studies have shown the therapies — currently approved for Type 2 diabetes and weight loss — can diminish the risk of multiple cancers:
      • “Compared with Type 2 diabetes patients taking insulin, those who took the medications were less likely to develop 10 of 13 obesity-related cancers, one study found. 
      • “In another study of Type 2 diabetes patients, GLP-1 users saw a decreased risk of colorectal cancer than those who took insulin, metformin, SGLT2 inhibitors, sulfonylureas and thiazolidinediones. 
      • “Both bariatric surgery and GLP-1 use reduced the risk of obesity-related cancers in a retrospective analysis, according to data presented at the American Society of Clinical Oncologists meeting in June. Post-surgery, the risk declined 22%; with GLP-1s, the risk fell 39%. 
    • “The results are promising, but oncologists will need to see more research before they change their practices.”
  • Per Health Day,
    • “Folks can overcome their genetic risk for type 2 diabetes through healthy diet and regular exercise, a new study says.
    • “A healthy lifestyle reduced the risk of type 2 diabetes by 70% among a group of people with a high genetic likelihood of developing the metabolic disorder, researchers found.
    • “In fact, healthy behaviors had a greater impact on their risk than it did for people with a low genetic propensity for type 2 diabetes, results showed. A healthy diet and exercise had a statistically insignificant impact on the diabetes risk of those with low-risk genetics, researchers found.
    • “Nevertheless, “these findings encourage everyone to make lifestyle changes that promote health,” said lead researcher Maria Lankinen, a lecturer in nutrition with the University of Eastern Finland.
    • “That’s because all participants tended to achieve better blood sugar control and lost weight if they engaged in a healthy lifestyle, researchers said.”
  • The Wall Street Journal notes,
    • “Multiple servings of milk, cheese or yogurt have long been a staple of American nutrition advice. Now a growing number of researchers and doctors say you need less dairy than you think, and maybe even none at all.
    • “The U.S. government, which recommends that adults eat three servings of dairy a day, is taking a fresh look at its guidance. A committee of scientific advisers is analyzing diets with lower amounts of dairy to study what happens to people’s nutrient levels. That is the first step toward possibly changing the recommendation in the next update of the country’s dietary guidelines. Other countries already recommend less dairy than the U.S. does.
    • “The problem? Dairy-rich diets have been linked to increased risks of cardiovascular diseaseand certain cancers in some studies. Foods like ice cream, full-fat cheese and pizza are high in calories and saturated fat. 
    • “However, the research isn’t clear-cut. Some studies link dairy foods to a lower risk of heart disease, some cancers and Type 2 diabetes. When it comes to milk, scientists can’t agree on whether full fat or skim is better. 
    • “Long story short: Go ahead and enjoy your Greek yogurt and that mozzarella in your caprese salad. Just don’t have too much; some experts say one serving a day—one cup of yogurt or 1.5 ounces of the cheese—is good.” 
  • The New York Times warns us,
    • “Even light drinking was associated with an increase in cancer deaths among older adults in Britain, researchers reported on Monday in a large study. But the risk was accentuated primarily in those who had existing health problems or who lived in low-income areas.
    • “The study, which tracked 135,103 adults aged 60 and older for 12 years, also punctures the long-held belief that light or moderate alcohol consumption is good for the heart.
    • “The researchers found no reduction in heart disease deaths among light or moderate drinkers, regardless of this health or socioeconomic status, when compared with occasional drinkers.
    • “The study defined light drinking as a mean alcohol intake of up to 20 grams a day for men and up to 10 grams daily for women. (In the United States, a standard drink is 14 grams of alcohol.)
    • “We did not find evidence of a beneficial association between low drinking and mortality,” said Dr. Rosario Ortolá, an assistant professor of preventive medicine and public health at Universidad Autónoma de Madrid and the lead author of the paper, which was published in JAMA Network Open.
    • “On the other hand, she added, alcohol probably raises the risk of cancer “from the first drop.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “U.S. nonprofit hospitals and health systems’ median days of cash on hand hit a 10-year low in 2023, falling below 200 days for the first time in a decade, according to a report from S&P Global Ratings.
    • “Cash flow did not meaningfully improve from 2022 to 2023, the report said. However, operating expenses grew only modestly at 5%, following a steep 17% growth rate in 2022.
    • “While the sector is making incremental progress toward financial recovery, performance metrics are still below providers’ financial targets. The authors also noted a growing gap between the sector’s top performers and weaker providers.”
  • The American Journal of Managed Care examines “Hospitals’ Strategies to Reduce Costs and Improve Quality: Survey of Hospital Leaders.”
    • “Takeaway Points
    • “A decade after the implementation of value-based payment models, little is known about the strategies hospitals currently use to improve outcomes and reduce costs.
    • “On average, across 20 strategies in 4 domains—inpatient, post-acute, outpatient, and community resources for vulnerable patients—hospitals reported having implemented between 65% and 89% of the strategies queried.
    • “A higher proportion of hospitals participating in bundled payments implemented interventions aimed at reducing post-acute care compared with other hospitals (78.3% vs 37.6%; P < .0001), but patterns were otherwise similar.
  • Beckers Hospital Review looks into why Kaiser Permanente is having success with its retail clinics located inside Target stores in southern California.
  • Beckers Payer Issues explores UnitedHealthcare’s approach to consumerism in 2024.
  • Fierce Healthcare reports,
    • While customer satisfaction with mail order pharmacies is continuing to grow, brick-and-mortar pharmacies are falling behind, according to a new survey from J.D. Power.
    • The firm’s annual Pharmacy Survey found that retail pharmacies saw overall satisfaction scores decrease by more than 10 points, while scores for mail order pharmacies grew by six. The survey found that consumers visiting brick-and-mortal facilities are facing long-wait times and issues in ordering prescriptions, which is worsening the experience.
    • What brick-and-mortar pharmacies do best is communicate clearly with consumers, according to the survey, with 89% of customers indicating that messages from the pharmacist were offered clearly and understood.
    • However, there’s a trust gap. Only 51% said they view their pharmacist as trustworthy, and the same percentage said prescriptions were filled quickly.
    • Building that trust is critical to improving the consumer experience, Christopher Lis, managing director of global healthcare intelligence at J.D. Power, told Fierce Healthcare in an email interview.
    • [T]here is room for improvement for mail order pharmacies as well, the study found. While the key factor consumers enjoy is the convenience of ordering prescriptions, just 18% of consumers said that their pharmacy has a well-designed digital experience.
  • Per Fierce Pharma,
    • “Ascendis Pharma should be well prepared for the U.S. launch of its hormone replacement therapy for hypoparathyroidism, which was approved on Friday by the FDA.
    • “After all, the company was initially set to bring the drug to the market 15 months ago before the FDA rejected it with a surprise complete response letter (CRL). Then three months ago, Ascendis again was ready to roll before the U.S. regulator said it needed an additional three months to make its decision.
    • “Finally, Copenhagen-based Ascendis is now good to go with once-daily Yorvipath (palopegteriparatide), also known as TransCon PTH, which is the first FDA-approved product for hypoparathyroidism in adults.
    • Ascendis expects the initial supply to be available in the first quarter of next year with the potential to move the launch up to the fourth quarter this year, as the company has requested FDA approval to commercialize doses it has already made.
  • and
    • “With Gilead Sciences’ stated focus to grow in oncology, the company’s recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. But, with a unique pre-exposure prophylaxis (PrEP) offering for HIV that could “redefine” the market, the drugmaker is touting lofty ambitions there, too.
    • “After scoring an FDA approval for Sunlenca (lenacapavir) to treat multidrug-resistant HIV, Gilead launched the drug at end of 2022. The drug’s every-six-month dosing schedule has yet to show its full potential given that it must still be paired with other daily drugs to form a complete regimen. The indication isn’t exactly a major sales driver, as Sunlenca’s approved patient population represents just 2% of adults with HIV.
    • “That approval was just “the beginning of the rest of this journey,” Gilead’s vice president of clinical development Jared Baeten, M.D., Ph.D., said in an interview at the time. Now, the company is looking to another milestone late next year with the planned commercial launch of Sunlenca as a long-acting PrEP med, CEO Daniel O’Day said on Gilead’s second-quarter earnings call.” 

Weekend Update

David Ermer–CDC, Congress, COVID-19, Medical / Rx research, OPM–

From Washington, DC,

  • The House of Representatives and the Senate are on District / State work breaks until September 9.
  • Federal News Network reports,
    • “After more than a year of pressure building in Congress, lawmakers now have more answers on federal telework levels, return-to-office policies and office space plans from the White House.
    • “In a report the Office of Management and Budget sent to Congress Friday afternoon, shared with Federal News Network, the Biden administration released details on agencies’ varying policies and approaches to where and how federal employees work, as well as federal real estate holdings and plans to improve office space utilization.
    • “While noting that more than half of the federal workforce is not able to telework at all, OMB reported that agencies are on average exceeding the administration’s 50% in-the-office goal for telework-eligible feds. Governmentwide, roughly 61% of the work hours that telework-eligible federal employees performed have been in person, according to time and attendance data OMB collected from the 24 CFO Act agencies during two pay periods in May.
    • “Also based on agencies’ time and attendance data, OMB reported that out of about 2.2 million federal employees:
    • “About 54% of federal employees worked fully in person due to the nature of their work
    • “About 46% of federal employees were eligible for telework
    • “About 10% of federal employees worked fully remotely.

From the public health and medical research front,

  • Per NPR Shots,
    • “Four years after SARS-CoV2 sparked a devastating global pandemic, U.S. health officials now consider COVID-19 an endemic disease.
    • “At this point, COVID-19 can be described as endemic throughout the world,” Aron Hall, the deputy director for science at the CDC’s coronavirus and other respiratory viruses division, told NPR in an interview.
    • “That means, essentially, that COVID is here to stay in predictable ways. 
    • “The classification doesn’t change any official recommendations or guidelines for how people should respond to the virus. But the categorization does acknowledge that the SARS-CoV2 virus that causes COVID will continue to circulate and cause illness indefinitely, underscoring the importance of people getting vaccinated and taking other steps to reduce their risk for the foreseeable future.” * * *
    • “We’re going to have to continue to live with COVID,” says Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. “It’s one more thing people have to deal with. It’s another reason your kids might miss school, or you might miss work or another thing to think about when planning gatherings. We’re stuck with it.”
  • The Washington Post lets us know,
    • “Mammogram callbacks are common — about 10 out of every 100 womenare told they need more imaging after an initial screening, according to the American College of Radiology — but can be scary, especially if you have to wait for an appointment. The vast majority of the callbacks, however, turn out to be false alarms, according to the American Cancer Society. Fewer than 1 in 10 women who return for more imaging have cancer.
    • “Women should never ignore a callback, which usually involves more extensive pictures, known as a diagnostic mammogram, and sometimes will require a sonogram and biopsy, experts say. Early detection of breast cancer usually means less-invasive treatment and high survival, more than 90 percent five years out, experts say.
    • “Callbacks happen frequently and with good reason, because we want to be sure,” says Karen E. Knudsen, chief executive officer of the American Cancer Society. “Most of the time, nothing is wrong. But if you get a callback, make the appointment.”
  • and
    • “Women who have not been very physically active over the years were 40 percent more likely to experience a fall when they reached their 70s, according to new research published in the British Journal of Sports Medicine.
    • “The study involved over 11,700 participants (with an average age of 54) in the Australian Longitudinal Study on Women’s Health, which has been following the health of over 57,000 Australian women in four different age cohorts.
    • “For this study, which lasted 18 years, women born from 1946 to 1951 reported every three years how much exercise they had been getting. That level of weekly physical activity participation was based on the total of three types of exercise: walking briskly and moderate and vigorous leisure activity. When participants were age 68 to 73, they were also asked about falls and related injuries they had experienced.”
  • Fortune Well offers tips on how to improve your chances of becoming a SuperAger.
    • “Some people have won the longevity lottery—they are among the lucky few known as SuperAgers. 
    • “In a relatively new field, researchers are examining what contributes to people in their 80s and 90s having stronger brain power than their peers. Many are wondering if those findings can be distilled into a longevity routine or pill to help everyone become a SuperAger. Is it possible to increase your odds of becoming a SuperAger? 
    • “It’s not inevitable that we will become disabled and sick as we get older. What we’re learning from these unique individuals is that it is biologically plausible for us to live long and healthy,” says Dr. Sofiya Milman, the director of the Human Longevity Studies at Einstein’s Institute for Aging Research and the lead investigator of the SuperAgers Family Study, which has enrolled 550 SuperAgers since 2022. “Once we know what causes longevity, that it’s not a disease, we can then create therapies that will promote that biological longevity, and ultimately, that’s the goal of what we’re doing.” 

From the U.S. healthcare business front,

  • Per HR Dive,
    • “Employers may continue to use the most recent Form I-9 until May 31, 2027, U.S. Citizenship and Immigration Services said last week, extending the document’s expiration date.
    • “HR professionals must ensure they’re using the form with an Aug. 1, 2023, edition date, according to the agency. Newly downloaded forms will bear the new expiration date but employers may — for now — continue using any previously downloaded or printed forms bearing the previous July 31, 2026, expiration date. 
    • “Either form may be used until its respective expiration date,” USCIS said in a statement. However, “[e]mployers are encouraged to update their electronic Forms I-9 systems to use the [2027] expiration date as soon as possible and must do so no later than July 31, 2026,” it said.
  • Per Legal Dive,
    • “States and local governments should prohibit employers from using non-disclosure and non-disparagement agreements to keep employees from speaking out about sexual and other types of harassment, the American Bar Association says.
    • “NDAs … have effectively resulted in silencing people who experience sexual assault, sexual harassment, and other forms of harassment and discrimination in the workplace, preventing accountability for those who commit these harms and allowing the behavior to persist,” the ABA says.” * * *
    • “The resolution comes at a time when employers could be turning to NDAs even more if a nationwide ban on noncompete agreements takes effect this fall. The Federal Trade Commission passed the ban, but it faces court challenges, one of which has resulted in a partial stay. 
    • “Should the ban take effect, employers are likely to lean more heavily on other types of agreements, like non-disparagement agreements and other types of NDAs, to protect their interests from employees who leave to work for a competitor or to start a competing business.”

Friday Factoids

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Food and Drug Administration turned down an ecstasy-based drug.
    • “The agency rejected use of the drug, known as MDMA, along with mental-health therapy in the treatment of post-traumatic stress disorder.  It asked Lykos Therapeutics, which had sought the approval, to test the drug therapy further, the company said Friday.
    • “The decision is a setback for decades of efforts to legalize psychedelics and a disappointment for veterans advocates and other groups that have been seeking a new, better medicine for treating the 13 million Americans with post-traumatic stress.
    • “Yet it isn’t a surprise, after FDA staff and expert advisers raised questions about the studies evaluating whether the MDMA drug from Lykos Therapeutics worked safely.
    • “Lykos said the FDA told the company it couldn’t approve the drug therapy based on the data submitted to date. The company said it would ask the FDA to reconsider its decision, as well as to discuss the agency’s recommendations for submitting another application.”
  • The Washington Post adds,
    • “The Food and Drug Administration on Friday approved a nasal spray for serious allergic reactions to food, medications and insect stings, marking the first needle-free treatment for such conditions.
    • “The epinephrine nasal spray is administered as a single dose in one nostril and will serve as a critical alternative to treating emergency allergic reactions without an injection, the agency said.
    • “The two-milligram spray, called Neffy, is designed to block allergic reactions, including a serious condition called anaphylaxis, which can happen within seconds or minutes of being exposed to an allergen.
    • “The decision introduces an alternative to auto-injector devices such as the EpiPen for blocking severe allergic reactions. It also vindicates the approach of Neffy manufacturer ARS Pharmaceuticals, which pitched its product as a superior way of treating anaphylaxis that overcomes people’s hesitation to inject themselves or someone else. Anaphylaxis can cause constriction of the airway.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “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, with substantial increases in the southern United States. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, 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’s CIDRAP adds,
    • Wastewater detections continue to rise steadily and are now at the very high level. Levels continue to trend upward in all US regions and are highest in the West, followed by the South and Midwest. Test positivity for COVID is still rising and is at 17.6% nationally, up 1.2% compared to the previous week. Test positivity is highest in the region that includes Texas and surrounding states. 
  • and
    • “Among US children born in the past 30 years, childhood vaccines have prevented an estimated 508 million cases of illness, 32 million hospitalizations, and 1.1 million deaths, resulting in direct savings of $540 billion and societal savings of $2.7 trillion, according to a study yesterday in Morbidity and Mortality Weekly Report.
    • “Researchers from the Centers for Disease Control and Prevention (CDC) analyzed data since 1994, when the US Vaccines for Children (VFC) program was launched to cover the cost of vaccines for children whose families might not be able to afford them. They assessed the impact of routine childhood immunizations among both VFC-eligible and non–VFC-eligible children born from 1994 to 2023 for nine vaccines: diphtheria and tetanus toxoids and acellular pertussis vaccine; Haemophilus influenzae type b conjugate vaccine; poliovirus vaccines; measles, mumps, and rubella vaccine; hepatitis B vaccine; varicella vaccine; pneumococcal conjugate vaccine; hepatitis A vaccine; and rotavirus vaccine.”
  • Health Day lets us know,
    • “U.S. doctors should be on the lookout for a more severe strain of mpox that is spreading widely in parts of Africa, federal health officials warned Wednesday.
    • “The alert, issued by the U.S. Centers for Disease Control and Prevention, came just hours after the World Health Organization’s Director-General Dr. Tedros Adhanom Ghebreyesu tweeted that he will be gathering a group of advisers to decide whether the mpox outbreak in Africa should be declared a public health emergency of international concern.
    • “Cases of what is known as the clade 1 strain of mpox haven’t yet been reported outside of central and eastern Africa, the CDC noted in its alert. But the likelihood of additional spread prompted the agency to recommend that doctors in this country consider this more dangerous strain of mpox in patients who have recently been in the Democratic Republic of Congo (DRC) or any neighboring country (Angola, Burundi, Central Africa).
    • “Still, “due to the limited number of travelers and lack of direct commercial flights from DRC or its neighboring countries to the United States, the risk of clade I mpox importation to the United States is considered to be very low,” the CDC added.”
  • The American Hospital Association News alerts us,
    • “The AHA yesterday sent a Special Bulletin to members notifying them of concerns by the American Red Cross, America’s Blood Centers and the Association for the Advancement of Blood and Biotherapies about the nation’s low supply of blood levels. Each of those organizations is urging individuals to donate to boost supplies. The blood groups said this summer’s record heat, as well as recent disruptions in blood collections in the Southeast United States — including a cyberattack on OneBlood and the Tropical Storm Debby — have created additional challenges for blood collection. The AHA is urging its members to ask their communities to donate blood.”
  • Medscape offers a commentary explaining why “Sex, Marriage, Race, Education: Four Factors Account for 18 Years of Life Expectancy.”
  • The FEHBlog post about a link to a Cleveland Clinic press release was missing the following quote from the document.
    • “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,” [lead researcher] 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.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Merck & Co. has struck a deal worth up to $1.3 billion to buy an investigational drug targeting B-cell associated diseases.
    • “Merck on Friday said it will pay an initial $700 million to acquire full global rights to clinical-stage bispecific antibody CN201 from privately held biotechnology company Curon Biopharmaceutical.
    • “Merck said CN201 is currently in studies in patients with relapsed or refractory non-Hodgkin’s lymphoma and B-cell acute lymphocytic leukemia.
    • “The Rahway, N.J., drugmaker said it plans to evaluate CN201 as a treatment for B-cell malignancies and to investigate its potential to provide a novel, scalable option for the treatment of autoimmune diseases.
    • “Merck said Curon also is eligible to receive up to $600 million in milestone payments associated with the development and regulatory approval of CN201.
    • “The company said it expects to complete the acquisition in the third quarter, adding that it will book a pretax charge of about $750 million, reflecting the upfront payment and other related costs.”
  • and
    • “Novo Nordisk had a big head start in the race to dominate the weight-loss market. But Eli Lilly is catching up fast.
    • “The two companies’ divergent earnings reports this week showed that Indianapolis-based Lilly is moving faster than its Denmark-headquartered counterpart in the race to win the GLP-1 war.” 
  • Healthcare Finance notes,
    • “Johns Hopkins Health Plans is wading further into the artificial intelligence waters with a partnership meant to ensure member compliance with the No Surprises Act.
    • “By adopting InsightPro from MDI NetworX, Johns Hopkins Health Plans (JHHP) is addressing what it sees as an issue surrounding the No Surprises Act: While the law created transparency for patients and protection against unexpected billing, it also brought new compliance requirements that left many health plans “scrambling,” according to Johns Hopkins.
    • “Ryan O’Donnell, chief operating officer for Johns Hopkins Health Plans, called the technology “innovative” and said it would ensure members have accurate, up-to-date provider information, and would promote trust in the company’s services.”
  • Kaufmann Hall posted an infographic on the state of American medical debt.
    • About 8% of American adults have at least some medical debt, although this percentage is much higher among certain populations including those in poor health, the uninsured, and Black Americans. The 14% of Americans who owe over $10K carry over three-quarters of the nation’s total medical debt burden. In contrast, the nearly 50% of Americans who owe less than $2K are responsible for just 5% of the medical debt total. Reporting changes recently implemented by the three major credit rating agencies have reduced the impact of medical debt on other aspects of consumers’ financial health, but mostly for smaller medical debtholders. By excluding medical debt in collections for less than a year as well as medical debt of less than $500 from appearing on credit reports, the share of Americans whose medical debt affects their credit score has dropped to 5%. 

Midweek Update

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Govexec reports,
    • “Federal agencies have not implemented roughly half of the 428 recommendations that the Government Accountability Office has made to improve preparedness following the COVID-19 pandemic, which has killed 1.2 million Americans. 
    • “In a report published on Aug. 1, the watchdog reviewed its oversight work concerning COVID-19 and the approximately $4.65 trillion Congress provided in response. GAO found that agencies haven’t addressed 220 of its recommendations. 
    • “Reflecting on federal agencies’ emergency response actions and our recommendations can reveal lessons from the COVID-19 pandemic for federal agencies. These lessons can help federal agencies identify actions that successfully facilitated the implementation of the federal response and should be incorporated into future emergency response plans. Other lessons can help federal agencies identify weaknesses in their response to the pandemic and identify areas for improvement,” GAO investigators wrote.”
  • 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), awarded nearly $9 million to 18 HRSA-funded health centers to improve access to life-saving cancer screenings in underserved communities. Health centers will partner directly with National Cancer Institute-Designated Cancer Centers to expedite patient access to cancer care and treatment. These awards advance the Biden Cancer Moonshot mission to prevent 4 million cancer deaths by 2047 and end cancer as we know it. This effort builds on work supported by the 21st Century Cures Act to expand use of proven cancer prevention and early detection strategies to reduce cancer risk in all populations.”
  • Federal News Network tells us about OPM telework guidance issued today.
    • “In the federal government’s case, remote work is distinct from telework. Federal employees with remote work agreements perform their job duties at a location away from their normal work site without the expectation of regularly returning to that site. In contrast, federal employees with telework agreements, by OPM’s definition, can perform their work away from the office — but are still expected to come to the worksite “on a regular and recurring basis.”
    • “OPM’s new guidance doesn’t change the definitions for federal remote work or telework, which are set in law, but rather provides additional clarifying guidance on how agencies should approach their workplace arrangements moving forward. In the document, OPM details what factors agencies should consider as they hammer out their remote work posture — both as it currently exists, as well as what it will look like in the future.
    • “The guidance builds on the Office of Management and Budget’s April 2023 memo that called on agencies to strike a balance between in-person work and telework, as well as 2021 OPM guidance that told agencies to weave telework and remote work into their workforce culture. Following those documents, OPM said human capital leaders and other senior executives asked for additional guidance on how to ensure agencies are relatively consistent as they consider changes to their remote work arrangements.
    • “OPM said it’s still up to each agency to determine the right balance for workplace flexibilities, such as remote work, for their employees. Agencies can decide if they want to offer remote work in the first place. They also have the authority to determine how they’d like to use the flexibility, and what positions are potentially good candidates for the alternative workplace arrangements.”

From the public health and medical research front,

  • American Hospital Association lets us know,
    • “The Centers for Disease Control and Prevention has updated respiratory syncytial virus vaccination recommendations for adults 60 and older. Adults aged 60-74 at increased risk for RSV and all aged 75 and older are recommended a single dose of the GSK, Pfizer or Moderna vaccine. Individuals who previously received a dosage should not seek another.” 
  • The New York Times reports,
    • “When exposed to a virus, the human body marshals the immune system to fend off the intruder. Sometimes, the defense goes awry, and the body mistakenly turns against itself instead of the attacker.
    • “This sort of friendly fire drives multi-inflammatory syndrome in children, or MIS-C, a mysterious condition that in rare cases strikes children who have had a severe bout of Covid-19, according to a new study.
    • “In a subset of children with the syndrome, immune cells become confused by the similarity between a protein carried by the coronavirus, and one found throughout the human body, said Joseph DeRisi, an infectious disease expert and the president of the Chan Zuckerberg Biohub in San Francisco, who led the study. This phenomenon is called molecular mimicry, Dr. DeRisi said.
    • The study was published on Wednesday in the journal Nature. The results offer the first direct proof that Covid-19 sets off an autoimmune reaction that leads to MIS-C.”
  • The Wall Street Journal alerts us,
    • “Antidepressants are one of several classes of medications that can make people more vulnerable to heat by tampering with the body’s internal thermostat or interfering with its cooling strategies. Others include antipsychotics, diuretics, stimulants and heart medications such as beta blockers and ACE inhibitors. 
    • “The risk is growing during longer, more frequent heat waves: Last summer was the hottest on record, and this one is setting records, too. The rate of emergency-room visits for heat-related illnesses was higher last summer than in the previous five.” * * *
    • “Many of these drugs are associated with an increased risk of heat-related hospitalizations, a study published in 2020 in the journal PLOS One found. But the extent to which these drugs pose risks isn’t well studied, said Dr. Soko Setoguchi, an epidemiologist at Rutgers University who co-wrote the study. Setoguchi said people should avoid heat, not their medication.”
  • Beckers Hospital Review informs us,
    • “Neuralink, a company co-founded by Elon Musk, has successfully implanted a second brain-computer interface device into a human subject, Nature reported Aug. 6.
    • “During a podcast released Aug. 2, Mr. Musk said the new implant is functioning well, with around 400 of its 1,042 electrodes actively transmitting signals from the person’s brain.
    • “Although details regarding the recipient or the specifics of the surgery were not disclosed, Mr. Musk said the individual, similar to the first recipient, suffers from a spinal cord injury. 
    • “The procedure comes after Neuralink’s first patient had a number of threads on the implant retracted from his brain shortly after the surgery.”
  • and
    • “New York City-based Hospital for Special Surgery has the lowest hospital wide readmission rate, according to CMS’s Unplanned Hospital Visits database.
    • “The data, released July 31, is based on provider data for hospital return days, including unplanned readmission measures in 2022.”
    • The article lists “the 10 hospitals with the highest and lowest hospital wide readmission rates, along with their respective scores.”
  • STAT News notes,
    • “Novo Nordisk is pulling its regulatory submissions to expand the use of its obesity drug Wegovy for a common type of heart failure, saying that waiting for more data on cardiovascular outcomes could bolster its case.
    • “Trials of Wegovy in the condition, heart failure with preserved ejection fraction (or HFpEF), have primarily looked at the drug’s effects on symptoms and physical function. The company plans to reapply to expand Wegovy’s label early next year when it has more data on complications such as hospitalizations and cardiovascular-related deaths, Martin Lange, Novo’s head of development, said Wednesday on an earnings call.” 
  • Per a National Institutes of Health press release,
    • “A National Institutes of Health (NIH)- supported study has found race- and sex-based differences in the increased chances of survival from people who received bystander cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest. Average survival benefits for cardiac arrest, when the heart suddenly stops beating, could be three times as high for white adults compared to Black adults and twice as high for men compared to women. The findings published in Circulation.
    • “CPR saves lives — that, we know,” said Paula Einhorn, M.D., a program officer at NIH’s National, Heart, Lung, and Blood Institute (NHLBI). “Yet the disparities revealed in this research show we need to do more to understand how to ensure equitable outcomes for all patients needing CPR. We’re hoping new insights will lead to better survival * * *.” * * *
    • “Prior research already found inequities in the frequency with which bystander CPR was being performed in Black and Hispanic individuals compared to white individuals, and with women compared to men in public places. In response, CPR training awareness and programs have expanded nationally, as have online courses. Mannequins resembling a woman’s body have also been designed.
    • “Evaluating access to and the effectiveness of different types of CPR trainings could be one way to identify differences in survival outcomes and inform solutions, according to researchers. For example, future studies could inquire about whether a bystander received online or in-person training; if they practiced on women mannequins or models with black or brown skin; if multiple bystanders were around, which may indicate a person had additional support; and what kind of support from emergency dispatchers they had — and for how long — which may reveal whether a person was receiving CPR instructions for the first time. Since the arrival times of emergency medical responders were fairly similar among groups, the researchers don’t believe this factored into outcomes observed in the study. Future studies could also explore the role that underlying health conditions may have in the survival outcomes of those who needed CPR.”

From the U.S. healthcare business front,

  • MedCity News reports,
    • “Hospital finances seem to be stabilizing overall — but a closer look shows that there is a widening gap between the highest- and lowest-performing organizations, according to a report released by Kaufman Hall this week.
    • “For the report, Kaufman Hall examined data from more than 1,300 hospitals. It showed that hospitals’ year-to-date operating margin index held steady at 4.1% in June for the second month in a row.” * * *
    • “Kaufman Hall also released another report on healthcare finances this week, with this one showing that rising labor costs are here to stay.: * * *
    • “This aligns with recent research from Strata Decision Technology, which showed that healthcare providers’ labor expenses grew by 5.2% while their non-labor costs rose by 3.3% from June 2023 to June 2024. This resulted in a 4.8% increase in overall expenses during the 12-month period, according to the report.” 
  • Healthcare Dive adds
    • “Tenet Healthcare will sell its majority ownership in Birmingham, Alabama-based Brookwood Baptist Health for about $910 million to Orlando Health, the health system said Monday.
    • “The sale, which is expected to close in the fall of this year, includes 70% of Tenet’s interest in the five-hospital system, as well as affiliated physician practices and other related operations. 
    • “The deal continues Tenet’s streak of divestitures as it looks to deleverage its portfolio. This year, the system has sold nine hospitals to Novant Health, UCI Health and Adventist Health for a combined after-tax profit of $3 billion.”
  • Beckers Payer Issues discusses payer efforts to defend affiliated prescription benefit managers.
  • The Wall Street Journal reports
    • “CVS Health’s Medicare business continued to struggle in the second quarter, fueling yet another cut to its full-year earnings outlook, a new $2 billion cost-cutting plan and the departure of a top executive. 
    • “CVS bet big on attracting seniors to its Aetna Medicare Advantage health plans last year, adding one million new people to its insurance rolls in 2024. But the gamble began backfiring in the first quarter of the year as seniors used more healthcare services than in the past and the government has become stingier in how much it pays private insurers. 
    • “On Wednesday, CVS said the pressures continued into the second quarter. The company reported total revenue of $91.2 billion in the quarter, up 2.6% from a year ago, and driven in large part by growth in its Medicare and commercial insurance businesses. 
    • But much of the sales increase was eaten up by higher medical costs, and adjusted earnings per share of $1.83 in the quarter were down 17.2% from last year. 
  • Beckers Payer Issues adds,
    • “Medicare Advantage costs could rise in the second half of 2024, CVS Health CEO Tom Cowhey told investors. 
    • “On an Aug. 7 call, Mr. Cowhey said costs in inpatient care, dental and pharmacy all rose toward the end of the second quarter. The company’s guidance for the rest of the year reflects that costs in the second half of the year could be higher than the first, the CFO said.” * * *
    • “Revenues in the company’s health benefits segment are down 40% year over year. The company ousted Aetna President Brian Kane over the financial results. Ms. Lynch and Mr. Cowhey will oversee Aetna’s day-to-day operations until a successor is named.” 
  • Per BioPharma Dive,
    • “Novo Nordisk shares tumbled 7% in early trading Wednesday after the company reported lower-than-expected revenue from its blockbuster obesity franchise.
    • “Even as revenue from Wegovy and Ozempic continued to soar, the second-quarter numbers failed to reach the high expectations set by Wall Street, analysts said. Sales of the so-called GLP-1 obesity drugs were about 9% below consensus estimates, according to analysts with the investment bank Jefferies.
    • “Overall revenue for the second quarter was “borderline in line with expectations,” Stifel analyst Eric Le Berrigaud wrote in a note to clients. But the fact that older products in Novo Nordisk’s portfolio helped offset the disappointing results for obesity drugs “is not so reassuring in the long term,” he wrote. The company’s “sales composition is not good.”
  • and
    • “The first medicine approved for a liver disease known as MASH is off to a faster launch than Wall Street analysts expected, according to quarterly results disclosed Wednesday by developer Madrigal Pharmaceuticals.
    • “Madrigal said its drug Rezdiffra, which was approved by the Food and Drug Administration in March and became available the following month, generated $14.6 million in U.S. sales in the second quarter. As of June 30, more than 2,000 patients were on treatment and coverage policies were in place for more than 50% of people with commercial health insurance, the company said.
    • “While only an early snapshot, the results surpassed consensus analysts estimates of about $4 million and have encouraged Madrigal to commercialize Rezdiffra in Europe on its own. An approval decision there is expected next year. “We’re still in the early stages, but we are confident that we’re building the foundation needed to create a blockbuster medicine,” CEO Bill Sibold told analysts.”

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.”

Friday Factoids

David Ermer–CDC, Congress, COVID-19, Mental health care, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • “Lawmakers on the Senate Appropriations Committee unveiled and unanimously advanced spending legislation Thursday effectively endorsing President Biden’s planned 2% average pay increase for federal workers in January, to the chagrin of federal employee groups and advocates.
    • “The committee moved four of the 12 fiscal 2025 appropriations bills Thursday, including the Energy and Water Development; Defense; Labor, Health and Human Services; and Financial Services and General Government Appropriations acts. That last bill is traditionally the avenue by which lawmakers seek to override a president’s alternative pay plan, and the committee’s draft is silent on most federal workers’ compensation rates, effectively endorsing the White House’s plan.” * * *
    • “With the GOP-controlled House Appropriations Committee’s version of the Financial Services and General Government spending package, advanced by the panel last month on a party-line vote, similarly endorsing the White House proposal, it is unlikely federal employees will see a raise larger than 2% next year.”
  • Bloomberg Law lets us know,
    • “The Biden administration failed to persuade the Fifth Circuit to reinstate rules making median network rates a primary consideration in deciding payment disputes under a law meant to prevent “surprise” medical bills. 
    • “In a Friday ruling, the appeals court upheld a lower court decision in favor of health-care providers that had vacated the regulations implementing the No Surprises Act from the Departments of Health and Human Services, Labor, Treasury, and Office of Personnel Management.
    • “Judge Jeremy Kernodle of the US District Court for the Eastern District of Texas had ruled in 2022 that the agencies didn’t abide by the text of the health-care benefits statute in issuing requirements that arbitrators must follow in payment dispute cases between medical providers and health insurers.
    • “The US Court of Appeals for the Fifth Circuit panel’s decision agreeing that the regulations violate the Administrative Procedure Act creates another significant setback for the government in its attempt to defend the rules governing the arbitration system from a spate of litigation.” * * *
    • “The DOL, HHS, and Treasury Departments did not immediately respond to requests for comment on the decision Friday.”
  • The National Committee for Quality Assurance has released information on its measurement year 2025 HEDIS measures.
    • “For Measurement Year 2025, NCQA added three HEDIS measures, retired four measures and made smaller changes across multiple measures. We also continue the transition to Electronic Clinical Data Systems (ECDS) reporting.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration on Thursday approved a new type of cellular medicine, clearing a therapy developed by the biotechnology company Adaptimmune for a rare soft tissue cancer called synovial sarcoma.
    • “The agency granted Adaptimmune’s therapy, formerly known as afami-cel and to be sold as Tecelra, an accelerated approval for use in some people with metastatic synovial sarcoma who previously received chemotherapy. Those people must have certain immune signatures and tumors expressing a protein, MAGE-A4, that Tecelra is designed to target.
    • “The FDA based its decision on Tecelra’s ability to spur tumor responses in about 43% of people who received it in a clinical trial, with responses lasting a median of about 6 months, according to the therapy’s new labeling. Adaptimmune has to confirm those benefits in an ongoing study to maintain the approval. The company expects to submit those results next year, executives said on a Friday conference call with analysts.”

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • Summary
      • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity 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 remain elevated, 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
  • Calculated Risk adds, “COVID in wastewater is increasing – especially in the West and South.” 
  • STAT News tells us,
    • “Untreated vision loss and high LDL cholesterol have been added as two new potentially modifiable risk factors for dementia in a report released Wednesday by the Lancet Commission.
    • “These new additions join 12 other risk factors outlined by the commission, affiliated with University College London, in previous reports on dementia prevention, intervention, and care in 2017 and 2020. The other risk factors are lack of education, hypertension, physical inactivity, diabetes, social isolation, excessive alcohol consumption, air pollution, smoking, obesity, traumatic brain injury, and depression.
    • “The commission’s latest findings suggest more ways of preventing dementia than previously known, according to Gill Livingston, a professor of psychiatry at University College London and co-author on the report.
    • “A lot of surveys have asked people of 50 and above what illnesses they most are concerned about, and dementia tends to come up as the highest one,” Livingston said. “And yet there’s really quite a lot that we can do to change the scales and make it less likely.”
  • Per Fierce Healthcare,
    • “CVS Health has launched an environmental health impact program to help vulnerable Americans during extreme weather events.
    • “The program, already live for a few weeks, initially focuses on extreme heat. Using advanced environmental data analytics and patients’ medical and pharmacy data, CVS Health offers timely excessive heat alerts and outreach to at-risk patients up to a week before the event. The initiative will expand to encompass air quality events this fall. It is initially available to members of Aetna with the goal of expanding to pharmacies and MinuteClinics.” * * *
    • “Heat waves and our changing environment is just such a pressing public health threat. I don’t think it’s appreciated nearly as much as it should be,” Dan Knecht, M.D., chief clinical innovation officer for CVS Caremark, told Fierce Healthcare.” * * *
    • “Consulting with experts in climate change and public health, CVS Health determined a wet bulb temperature threshold in the mid-80s Fahrenheit. Ingesting third-party weather data, it determines regions that surpass the limit and uses its own algorithm to stratify Aetna members by their vulnerability to extreme heat. Care managers who are registered nurses then reach out by phone, using an evidence-based framework for navigating the conversations. They provide information on the symptoms of heat stroke, how to minimize heat exhaustion and local resources such as cooling centers. Many Oak Street Health centers, now owned by CVS Health, can be used as a safe space to gather during extreme temperatures, Knecht said.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Contract disputes between hospitals and health plans have become routine, but they tend to be local, affecting a handful of hospitals and the people in the surrounding communities.
    • “This latest one is different. It involves the country’s biggest private health insurer, UnitedHealthcare, and its biggest hospital chain, HCA Healthcare. If they can’t strike a deal on prices by Sept. 1, 38 hospitals and their affiliated physician groups and surgery centers across four states — Texas, Colorado, South Carolina, and New Hampshire — would become out-of-network for UnitedHealthcare members. * * *
    • “UnitedHealthcare spokesperson Cole Manbeck said in a statement that HCA issued notices to end its contracts in four markets and demanded “significant price hikes that are not affordable or sustainable.” Manbeck said UnitedHealthcare shares the goal of reaching an agreement that ensures continued access to providers. He added that the parties could reach an agreement in one market and not another. “It’s not all or nothing,” he said.”
  • Per Healthcare Dive,
    • “Private equity firms TowerBrook Capital Partners and Clayton, Dubilier and Rice entered into a definitive agreement to acquire R1 RCM for about $8.9 billion and take the company private, the revenue cycle management firm said Thursday. 
    • “TowerBrook currently controls around 36% of the company’s shares, according to a press release. Under the deal, which will take R1 private, TowerBrook and CD&R will buy the rest of the company’s outstanding stock for $14.30 per share.
    • “The acquisition comes months after another private equity firm, New Mountain Capital, offered to buy out other investors for $13.75 a share— a price some analysts thought undervalued R1.” 
  • and
    • “Amwell boosted its adjusted earnings outlook for 2024 as the telehealth vendor works to cut costs and rein in expenses.
    • “The company now expects adjusted earnings before interest, taxes, depreciation and amortization to be a loss between $150 million and $145 million. It previously estimated adjusted EBITDA losses between $160 million and $155 million.
    • “Amwell also narrowed its net loss in the second quarter. The virtual care vendor reported a loss of $49.9 million, compared with $92.5 million during the same period last year.”