Tuesday Tidbits

Federal employment benefits

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.” 

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Per a Senate press release,
    • “Lawmakers are calling on the Government Accountability Office (GAO) to review the Medicare Part D Premium Stabilization Demonstration recently announced by the Centers for Medicare & Medicaid Services (CMS), noting its dubious legality and the danger it poses to health care affordability for seniors.  The effort comes as part of a letter to GAO from U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho), U.S. House Ways and Means Committee Chair Jason Smith (R-Missouri) and U.S. House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Washington).
    • “Through new taxpayer-financed policy adjustments, the demonstration seemingly intends to deflate seniors’ premiums that are otherwise slated to increase dramatically following the counterintuitive, haphazardly-written Inflation Reduction Act’s drug price provisions.  However, the agency has not produced any budgetary analysis and appears to lack a clear statutory basis or credible research goals for the proposal.  Crapo, Smith and McMorris Rodgers request GAO review the demonstration’s legality under section 402 of the Social Security Amendments of 1967; what budgetary analysis CMS undertook in developing the demonstration; and the estimated budgetary impact of the demonstration.”
  • FedWeek discusses similarities and differences between the House and Senate appropriations bills concerning federal workforce issues. For example,
    • “Both of the appropriations bills meanwhile would continue several long-running workplace policies that must be renewed annually. These include a general requirement that FEHB plans cover prescription contraceptives but not abortion; a ban on training not directly related to an employee’s official duties; and a ban on studying commercial type federal jobs for possible contracting-out.”
  • Reg Jones, writing in FedWeek, explains the nuts and bolts of FEHB coverage of young adult children.
  • Govexec informs us,
    • “The federal government’s dedicated HR agency reported a slight uptick in its backlog of pending federal employee retirement claims for the second straight month in July.
    • “Last month, the Office of Personnel Management reported that it received 6,451 new retirement requests, a decrease of roughly 450 cases from June. But despite increasing its output by more than 300 cases, processing 5,994 claims was not enough to stop the backlog from climbing from 15,340 in June to 15,797 last month.
    • “OPM’s goal is a “steady state” backlog of 13,000 pending claims in any given month. Since the backlog hit an eight-year low of 14,035 in May, the backlog has increased by nearly 1,800 cases.
    • “As a result, the monthly average processing time for a federal worker’s retirement request has increased from 61 days in May to 65 at the end of last month. Measured since the beginning of fiscal 2024 last October, the average wait time has remained static at 61 days since March.”

From the public health and medical research front,

  • The New York Times reports,
    • “In 2021, a survey by the Centers for Disease Control and Prevention on teen mental health focused on a stark crisis: Nearly three in five teenage girls reported feeling persistent sadness, the highest rate in a decade.
    • “But the newest iteration of the survey, distributed in 2023 to more than 20,000 high school students across the country, suggests that some of the despair seen at the height of the pandemic may be lessening.
    • “Fifty-three percent of girls reported extreme depressive symptoms in 2023, down from 57 percent in 2021. For comparison, just 28 percent of teenage boys felt persistent sadness, about the same as in 2021.
    • “Suicide risk among girls stayed roughly the same as the last survey. But Black students, who reported troubling increases in suicide attempts in 2021, reported significantly fewer attempts in 2023.” * * *
    • “For young people, there is still a crisis in mental health,” said Kathleen Ethier, head of the C.D.C.’s adolescent and school health program. “But we’re also seeing some really important glimmers of hope.”
  • WorldatWork informs us
    • “Current events and uncertainty about what the future holds is causing anxiety to increase at an alarming rate among U.S adults, according to the American Psychiatric Association’s 2024 mental health poll. This year’s version of the annual APA poll showed 43% of surveyed adults feel more anxious than they did last year, up from 37% in 2023 and 32% in 2022.
    • “According to the poll, which surveyed more than 2,200 adults, people are particularly anxious about current events, with 77% citing the economy as their greatest worry, while 73% of adults are anxious about the 2024 presidential election and 69% are anxious about gun violence.
    • “Other anxiety-inducing topics cited in the survey include safety related to family, self and identity; issues related to health; the ability to pay bills; climate change; the opioid epidemic; and advances in technology impacting day-to-day life. Americans also cited issues such as stress, sleep and social connections as contributing factors to their mental health.”
    • The article explains steps employers can take to help their employees with such problems.
  • The Wall Street Journal reports on an encouraging new approach to rotator cuff surgery that is based on the tooth structure of python snakes.
    • “When it comes to rotator cuff tendon tears, surgeons are trying to repair soft tissue back to bone, which is really stiff,” said Iden Kurtaliaj, lead author of the paper and a former biomedical engineering graduate student at Columbia. “So, if python snakes are capable of grasping soft tissue without tearing through it, [we thought] ‘Can we apply this concept to rotator cuff repairs?’”
    • “The device attaches to the shoulder bone and the tendon like a python grabs its prey, according to Kurtaliaj. In early experiments, the implant doubled the strength of repairs compared with commonly used suture restoration.”
    • The approach needs more refinement and government approval before it’s ready for prime time.
  • The New York Times lets us know,
    • “The United States spent $43 billion annually on screening to prevent five cancers, according to one of the most comprehensive estimates of medically recommended cancer testing ever produced.
    • “The analysis, published on Monday in The Annals of Internal Medicine and based on data for the year 2021, shows that cancer screening makes up a substantial proportion of what is spent every year on cancer in the United States, which most likely exceeds $250 billion. The researchers focused their estimate on breast, cervical, colorectal, lung and prostate cancers, and found that more than 88 percent of screening was paid for by private insurance and the rest mostly by government programs.
    • “Dr. Michael Halpern, the lead author of the estimate and a medical officer in the federally funded National Cancer Institute’s health care delivery research program, said his team was surprised by the high cost, and noted that it was likely to be an underestimate because of the limits of the analysis.
    • “For Karen E. Knudsen, the chief executive of the American Cancer Society, the value of screening for the cancers is clear. “We are talking about people’s lives,” she said. “Early detection allows a better chance of survival. Full stop. It’s the right thing to do for individuals.”
  • The Wall Street Journal warns us,
    • “Drinking water is crucial for preventing dehydration and keeping the body functioning, particularly in the heat of the summer. But consuming too much over a short period can lead to health problems including disorientation, nausea, vomiting and, in severe cases, seizures or death.
    • “Overhydration could be a growing issue, some researchers say, as more people train for endurance competitions like marathons, heat waves become more frequent and reusable water bottles become a staple of everyday life. The message of staying hydrated is so ubiquitous that 40-ounce, stainless-steel tumblers have become status symbols. 
    • “People have this fear that they’re always dehydrated or underhydrated and they need to fix that regularly,” said Colleen Muñoz, director and co-founder of the Hydration Health Center at the University of Hartford. “That’s probably not usually the case.”
    • “Water intoxication isn’t as well-known as dehydration. That can make it difficult to pinpoint the cause of symptoms, which can be similar to those associated with heat exhaustion or heat stroke, said Rayven Nairn, senior dietitian for student health and well-being at Johns Hopkins University.” 
  • Per a National Institutes of Health press release,
    • “A new study from the NIH National Institute of Neurological Disorders and Stroke on the occurrence of active epilepsy in sexual and gender minorities (SGM) highlights the importance of health disparities research. It found that SGM individuals—those who identify as gay, lesbian, bisexual, queer, transgender, non-binary, or gender-diverse—are twice as likely to report active epilepsy compared to their non-SGM counterparts. “Active epilepsy” means a person has been diagnosed with epilepsy and has had more than one seizure in the past year or is currently taking anti-seizure medication.” 

From the U.S. healthcare business front,

  • Per Beckers Payer Issues,
    • “Premiums for plans on the ACA marketplace will rise 7% on average in 2025, according to an analysis from Peterson-KFF Health System Tracker published Aug. 5. 
    • “Most insurers participating in the marketplace requested premium increases between 5% and 10%. Around 15% of plans requested rate decreases, and less than 10% requested rate increases higher than 15%. 
    • “The report analyzed public reports insurers made requesting premium increases. Several insurers said GLP-1 drugs, including Ozempic and Wegovy, are one of the things driving premium increases. 
    • “The pharmacy trend, especially cost, is heavily influenced by the impact of GLP-1 drugs and their use in diabetes treatment as well as the expectation for continued use with the approval for expanded indications,” Priority Health, a Michigan insurer, wrote.”
    • “Read the full report here.“
  • Per Beckers Hospital Review,
    • “Becker’s has compiled a list of the hospitals patients are most likely to recommend in every state using [recent] Hospital Consumer Assessment of Healthcare Providers and Systems data from CMS.
    • “CMS shares 10 HCAHPS star ratings based on publicly reported HCAHPS measures. The recommended hospital star rating is based on patients’ responses to the question, “Would you recommend this hospital to your friends and family?” Hospitals must have at least 100 completed HCAHPS surveys in a four-quarter period to be eligible for a star rating. Learn more about the methodology here.”
  • and
    • “More than 700 rural U.S. hospitals are at risk of closure due to financial problems, with more than half of those hospitals at immediate risk of closure.  
    • “The latest analysis from the Center for Healthcare Quality and Payment Reform, based on CMS’s July 2024 hospital financial information, reveals the financial vulnerability of rural hospitals in two categories: risk of closure and immediate risk of closure.
    • “In the first category, nearly every state has hospitals at risk of closure, measured by financial reserves that can cover losses on patient services for only six to seven years. In over half the states, 25% or more of rural hospitals face this risk, with nine states having a majority of their rural hospitals in jeopardy.
    • “The report also analyzes hospitals facing immediate threat of closure meaning financial reserves could offset losses on patient services for two to three years at most. Currently, 360 rural hospitals are at immediate risk of shutting down due to severe financial difficulties.”
    • The article breaks down by U.S. state and DC the number of hospitals in each category.
  • Per BioPharma Dive, “Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.”
  • MedTech Dive reports,
    • “Labcorp has received de novo authorization for a kitted, pan-solid tumor liquid biopsy test, the company said Friday.
    • “The product, PGDx elio plasma focus Dx, is a targeted blood test that profiles 33 cancer genes.
    • “Securing Food and Drug Administration authorization expands the cancer portfolio that Labcorp has built since buying Personal Genome Diagnostics (PGDx) for $450 million in 2022.”
  • MedCity News lets us know,
    • “Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure.
    • “In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure.”

Thursday Miscellany

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

From Washington, DC

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

From the public heal

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

From the U.S. healthcare business front,

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

Midweek update

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • At long last, the federal employee press is publicizing the Part D opt out penalty found in the proposed supplemental Postal Service Health Benefits (PSHB) Program rule.
  • Federal News Network reports, “There’s a catch in USPS insurance program for Medicare-eligible retirees. USPS annuitants who opt out of Medicare Part D will lose underlying prescription drug coverage, according to OPM’s [proposed] regulations.” Those opt out annuitants will continue to pay the full premium.
  • OPM reads the PSHB law as only offering Part D EGWP benefits to Part D eligible annuitants in the PSHBP. There is no underlying Rx coverage according to the agency’s FAQs. That statutory interpretation puts federal employees who live overseas in quite a pickle because Part D coverage is not available outside the United States.
  • In any case, it’s the FEHBlog’s legal opinion that the opt out penalty may not survive judicial review in our post-Chevron era, and because the penalty is roughly 20% of the premium, annuitants may be incented to bring a lawsuit challenging the penalty. Time will tell.
  • Govexec tells us,
    • “The Office of Personnel Management is opening a channel to provide federal employees affected by Hurricane Beryl to obtain emergency paid leave.  FEHBlog note: Beryl hit Houston TX hard.
    • “Acting OPM director Robert Shriver said in a July 19 memo that the agency had established an emergency leave transfer program, by which other federal employees may donate unused annual leave to impacted employees through the creation of agency leave banks. 
    • “Through the agency leave banks, impacted employees “who are adversely affected by a major disaster or emergency, either directly or through adversely affected family members, and who need additional time off from work” can utilize donated leave without having to use their own.” 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) has released new data on risk adjustment payments for 2023.
    • “The agency said (PDF) insurers participating on the Affordable Care Act’s exchanges will pay $10.3 billion as part of the risk adjustment program. Risk adjustment state transfers as a percent of premiums declined from 2022, according to the report.
    • “This trend is likely driven by shifts in the risk pools, according to CMS, which are likely impacted by ongoing insurer expansion into new regions.”
  • The American Hospital Association News informs us,
    • “The Substance Abuse and Mental Health Services Administration July 24 announced it is awarding $45.1 million in grants toward various behavioral health initiatives. The funding includes $15.3 million specifically planned to support children through mental health services in schools, services for those who have experienced traumatic events, and services specific to those at risk for or with serious mental health conditions.” 
  • Roll Call reports,
    • “House leaders canceled votes scheduled for next week as the GOP majority struggles to pass its fiscal 2025 appropriations bills.
    • “The decision to scrap next week’s session came a day after Republican leaders had to yank the Energy-Water spending bill from the floor amid growing doubts they could muster enough votes to pass it with their razor-thin majority. * * *
    • “GOP leaders all week had been mulling the possibility of sending members home early rather than remain in session next week as previously scheduled. Speaker Mike Johnson, R-La., said Wednesday that the decision to cancel votes next week wasn’t a direct result of problems with the appropriations bills.
    • “It’s not related to that. We’ve had a tumultuous couple of weeks in American politics and everybody’s, to be honest, still tired from our convention, and it’s just a good time to give everybody time to go home to their districts and campaign a little bit. We’ll come back and regroup and continue to work on this.”
    • “Johnson also said funeral arrangements for Rep. Sheila Jackson Lee, D-Texas, who died last weekend after a battle with pancreatic cancer, would pose logistical challenges next week. Johnson said a lot of members would want to attend the events, to be held in Houston, which could keep members away from Washington for three days.”
  • Per a Senate press release,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and five senators today introduced a bill to apply criminal penalties to rogue insurance brokers who are changing Americans’ Affordable Care Act (ACA) marketplace plans without their knowledge or consent, and take other steps to strengthen consumer health insurance protections. * * *
    • “The one-pager is available here. A summary of the bill is available here. The bill text is available here.”

From the public health and medical research front

  • ABC News relates,
    • “So far, only 25 cases of West Nile virus have been reported in 14 states, according to data from the Centers for Disease Control and Prevention. This is lower than the 117 cases reported at the same time last year. * * *
    • “Mosquitoes typically become infected with the virus after feeding on infected birds and then spread it to humans and other animals, the federal health agency said. Cases typically begin rising in July and are highest in August and September, CDC data shows.
    • “The majority of people with the virus do not have symptoms, but about one in five will experience fever along with headaches, body aches, joint pain, diarrhea, vomiting or a rash. Most symptoms disappear but weakness and fatigue may last for weeks or months.
    • “About one in 150 will develop severe disease leading to encephalitis, which is inflammation of the brain, or meningitis, which is inflammation of the membranes that surround the brain and spinal cord — both of which can lead to death. So far this year, 11 of the 25 cases have resulted in neuroinvasive disease, according to the CDC.
    • “There are currently no vaccines or specific treatments available for West Nile virus. The CDC recommends rest, fluids and over-the-counter medications. For those with severe illness, patients often need to be hospitalized and receive support treatments such as intravenous fluids.
    • “To best protect yourself, the CDC suggests using insect repellant, wearing long-sleeved shirts and pants, treating clothing and gear and taking steps to control mosquitoes. This last step includes putting screens on windows and doors, using air conditioning and emptying out containers with still water.”
  • The New York Times adds,
    • “As the bird flu outbreak in dairy cows has ballooned, officials have provided repeated reassurances: The virus typically causes mild illness in cows, they have said, and because it spreads primarily through milk, it can be curbed by taking extra precautions when moving cows and equipment.
    • “A new study, published in Nature on Tuesday, presents a more complex picture.
    • “Some farms have reported a significant spike in cow deaths, according to the paper, which investigated outbreaks on nine farms in four states. The virus, known as H5N1, was also present in more than 20 percent of nasal swabs collected from cows. And it spread widely to other species, infecting cats, raccoons and wild birds, which may have transported the virus to new locations.
    • “There’s probably multiple pathways of spread and dissemination of this virus,” said Diego Diel, a virologist at Cornell University and an author of the study. “I think it will be really difficult to control it at this point.” * * *
    • Although many infected cows did recover on their own, the researchers found, two farms reported a spike in cow deaths. On the Ohio farm, 99 cows died over the course of a three-week outbreak, a mortality rate roughly twice as high as normal.
    • “I think the potential for this virus to cause very serious disease has been downplayed a bit,” said Richard Webby, an influenza expert at St. Jude Children’s Research Hospital, who was not involved in the new study. “That has probably hurt the response.”
    • “Still, Dr. Diel noted, the cause of these deaths remains unknown. “Whether the mortality observed in those cases was due directly to influenza or whether the influenza infection led to a secondary bacterial infection, I think that’s a question that remains to be answered,” he said.”
  • Per BioPharma Dive,
    • “An experimental gene therapy from Pfizer succeeded in a Phase 3 study of people with hemophilia A, overcoming safety concerns that had put the trial on hold for almost a year.
    • “The treatment, giroctocogene fitelparvovec, is a one-time infusion designed to help patients produce a protein called Factor VIII that’s needed for normal blood clotting. Currently, people with hemophilia A use infusions of Factor VIII to prevent bleeding episodes.
    • “In the AFFINE study, researchers followed 75 patients for at least 15 months after they received Pfizer’s therapy. Study participants had fewer bleeding episodes and higher levels of Factor VIII, compared with standard prophylactic treatment before the infusion, Pfizer said Wednesday. Only one treated patient returned to prophylactic infusions.”
  • Healio notes that “In a single-center cohort of patients with heart failure and obesity, weight-loss surgery led to improved clinical outcomes including reduced BMI and HbA1c and less reliance on diuretics, researchers reported.”
  • mHealth Intelligence reports,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Humana’s CenterWell is planning to open 23 clinics at Walmart locations in four states, the company announced Wednesday.
    • “The health clinics will operate in space that previously held Walmart’s own clinics, according to the announcement. CenterWell intends to have the locations across Florida, Georgia, Missouri and Texas fully equipped, staffed and opened by the first half of 2025.
    • “The locations will operate under both the CenterWell and Conviva brands, providing senior-focused primary care. CenterWell is the fastest-growing senior-focused primary care provider in the nation, Humana said.”
  • Per Healthcare Dive,
    • “S&P Global Ratings analysts have downgraded Walgreens Boot Alliance by two notches, to ‘BB’ from ‘BBB-’, which puts the drugstore company into speculative-grade territory.
    • ‘Analysts Diya Iyer and Hanna Zhang cited guidance for the year “notably below” their expectations, and said “material strategic changes, limited cash flow generation, and large maturities in coming years are key risks to the business.”
    • “The company is struggling in its retail business as well as its pharmacy operations, they said in a Friday client note. In the U.S., margins are taking a hit on the pharmacy side from reimbursement pressure and on the retail side from declining sales volume and higher shrink. They expect Walgreens’ S&P Global Ratings-adjusted EBITDA margin to decline more than 100 basis points this fiscal year, dipping below 5%, from 6% last year, though the company’s cost cuts will counter that somewhat.”
  • MedTech Dive points out the top five medtech deals in the first half of 2024.
  • Per HR Dive,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

    Friday Factoids

    David Ermer–CDC, COVID-19, Cybersecurity, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–

    From Washington, DC,

    • Govexec reports,
      • “The Office of Personnel Management on Thursday encouraged federal agencies to conduct their own analyses to correct potential pay disparities within their workforces.
      • “In 2021, President Biden signed a sweeping executive order aimed at improving diversity, equity, inclusion and accessibility at federal agencies, including provisions requiring the creation of a governmentwide strategic plan on the issue and that the OPM director consider banning the use of past salary history to set pay during the hiring process. OPM followed through on that edict earlier this year.
      • “In a memo to agency heads Tuesday, acting OPM Director Ron Shriver highlighted OPM’s governmentwide study of pay gaps in the federal workforce, which found that in 2022, the gender pay gap was 5.6%, meaning women on average earned about 94 cents for every dollar male federal workers earned. The figure marks a slight improvement over the 2021 gender pay gap of 5.9% and is significantly better than the nationwide gender pay disparity of 16%.
      • “Shriver directed that federal agencies that operate their own pay systems governing at least 100 employees must now conduct the same review of pay policies that OPM did for the General Schedule, Federal Wage System and Senior Executive Service workforces. And he encouraged all agencies to conduct their own gap analyses to search for pay disparities along gender or racial and ethnic lines affecting their own workforces, regardless of pay system.”
    • HHS’s Administration for Strategic Preparedness and Response announced,
      • “awards totaling $18.5 million to two U.S. companies to expand the nation’s manufacturing of key starting materials and active pharmaceutical ingredients needed to make essential medicines. The awards are the first through ASPR’s BioMaP-Consortium, a public-private partnership established in January 2024.
      • “ASPR is committed to expanding our nation’s domestic manufacturing infrastructure,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “Today’s announcement advances our efforts to build resilient U.S.-based supply chains for pharmaceutical ingredients and mitigate risk and reliance on foreign supplies. Having this capability in the U.S. is critical for our emergency preparedness.”
      • “California-based Antheia will receive approximately $11 million to support U.S.-based production of pharmaceutical ingredients, and Virginia-based Capra Biosciences will receive approximately $7.5 million to leverage its bioreactor platform to manufacture three active pharmaceutical ingredients.” 
    • Mercer Consulting projects that for 2025 the health flexible spending account contribution limit will increase by $100 from $3200 to $3300 and the carryover limit will increase from $640 to $660.”

    From the public health and medical research front,

    • The CDC tells us today
      • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in many areas.
      • COVID-19
        • Many areas of the country are experiencing consistent increases in COVID-19 activity. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are increasing, particularly among adults 65+. CDC will continue to closely monitor trends in COVID-19 activity.
      • Influenza
      • RSV
        • Nationally, RSV activity remains low.
      • Vaccination
    • The University of Minnesota’s CIDRAP notes,
      • Along with the CDC’s report of high wastewater levels of SARS-CoV-2, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, notes that detections are in the high category, with no significant trend up or downward over the past 3 weeks. It said all regions of the country are in the high category, except for the Midwest, which is at the medium level.
    • STAT News adds,
      • “STAT spoke with experts in infectious disease, virology, and public health to find out what people need to know about this summer’s Covid surge.
      • “One key message: Despite the increase in cases, the protection people have built up thanks to rounds of vaccination and prior infections is still sparing the vast majority of people from severe illness.”
      • “Once you really get a decent immunity, you may get the virus again, but you’re probably not going to get very sick from it,” said Aaron Glatt, chair and professor of medicine at Mount Sinai South Nassau.”

    From the U.S. healthcare business front,

    • The American Hospital Association News lets us know,
      • “A non-malicious global technology outage that began in the early morning of July 19 is continuing to affect many industries and is having varying effects on hospitals and health systems across the country. The outage was caused by a faulty software update issued by the cybersecurity firm CrowdStrike, which is widely used by businesses and government agencies that run on Microsoft computers. 
      • “CrowdStrike is actively working with customers impacted by a defect found in a single content update for Windows hosts,” the organization posted on its website early today. “Mac and Linux hosts are not impacted. This is not a security incident or cyberattack. The issue has been identified, isolated and a fix has been deployed. We refer customers to the support portal for the latest updates and will continue to provide complete and continuous updates on our website. We further recommend organizations ensure they’re communicating with CrowdStrike representatives through official channels.
      • “CrowdStrike’s webpage includes more information about the issue and workaround steps organizations can take. The Cybersecurity and Infrastructure Security Agency also posted an alert on the incident.” 
    • The Hill reports,
      • “After peaking during the COVID-19 pandemic, physician burnout has dipped under 50 percent for the first time in four years, but doctors say working conditions in the medical field remain far from ideal. 
      • “A survey published by the American Medical Association (AMA) this month found that 48.2 percent of physicians in 2023 experienced at least one symptom of burnout, down nearly 15 percent from when this metric peaked in 2021. 
      • “Reported job satisfaction rose from 68 percent to 72.1 percent between 2022 and 2023, while job stress dropped in the same time frame, going from 55.6 percent to 50.7 percent. 
      • “It’s good news and it’s bad news,” Steven Furr, president of the American Academy of Family Physicians, told The Hill. “It’s good news that the numbers have gone down but still they’re higher than what we’d like them to be.” 
      • “The AMA has tracked physician burnout rates since 2011 along with the Mayo Clinic and Stanford Medicine. Prior to the pandemic, burnout rates ranged from 43.9 percent in 2017 to 54.4 percent in 2014.” 
    • mHealth Intelligence points out,
      • “Telehealth visits at United States hospitals skyrocketed during the COVID-19 pandemic, rising 75 percent between 2017 and 2021; however, adoption was uneven, with hospitals citing challenges to electronic health information exchange, according to a new study.
      • “Published in the Journal of General Internal Medicine, the study examined US hospitals’ adoption of telehealth before and during the pandemic, aiming to provide targeted policy implications.” * * *
      • “The researchers found that telehealth encounters increased from 111.4 million in 2020 to 194.4 million in 2021, a 75 percent jump. Additionally, hospitals offering at least one form of telehealth increased from 46 percent in 2017 to 72 percent in 2021.
      • “However, the adoption was not uniform across hospitals. Larger, nonprofit, and teaching hospitals were more likely to adopt telehealth than their counterparts. Notably, the study found no significant telehealth adoption disparities between hospitals in urban and rural areas.
      • “Further, more than 90 percent of hospitals allowed patients to view and download medical records, but only 41 percent permitted online data submission. One-quarter (25 percent) of hospitals identified certified health IT developers, such as EHR vendors, as frequent culprits in information blocking.
      • “Most US hospitals also reported challenges in exchanging health information electronically, with 85 percent citing barriers related to vendor interoperability.
      • “The researchers concluded that comprehensive policy interventions are necessary to address telehealth adoption and other IT-related disparities across the US healthcare system.”

    Thursday Miscellany

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

    From Washington, DC,

    • Modern Healthcare reports,
      • “A powerful Senate committee plans to commence a bipartisan investigation into the Steward Health Care meltdown next week.
      • “The Senate, Health, Education, Labor and Pensions Committee will convene next Thursday for a vote to officially kick off a probe into the insolvent Dallas-based health system. Steward Health Care Chair and CEO Dr. Ralph de la Torre will be subpoenaed to testify at a hearing Sept. 12, HELP Committee Chair Bernie Sanders (I-Vt.) and ranking member Dr. Bill Cassidy (R-La.) said in a news release Thursday.
      • “Given the serious harm and uncertainty Steward’s bankruptcy and financial arrangements are having on hospitals, patients and healthcare workers throughout the country, Dr. de la Torre has given us no choice but to compel him to testify at this hearing,” Sanders and Cassidy said.
      • “De la Torre declined to attend a HELP Committee hearing last month and a subcommittee session in April.
      • “We have a number of questions to ask Dr. de la Torre about the bankruptcy of Steward Health Care and the financial arrangements leading up to its insolvency. It is time for Dr. de la Torre to answer them before Congress and the American people,” Sanders and Cassidy said.
    • Federal News Network informs us,
      • “The Office of Personnel Management will soon be reopening enrollments into the government’s Flexible Spending Account program, FSAFEDS.
      • “OPM previously suspended all new enrollments in the program after a recent surge in fraudulent activity that impacted hundreds of federal employees with Flexible Spending Accounts. OPM’s inspector general said the suspension came “out of an abundance of caution,” and to try to prevent further fraud in the program.
      • “Enrollments in FSAFEDS, including any enrollments based on Qualifying Life Events (QLEs), will reopen Aug. 1, OPM wrote in an email to agency benefit officers Thursday afternoon, shared with Federal News Network. Also beginning Aug. 1, the program will transition to a “.gov” website domain, FSAFEDS.gov, rather than the current domain, FSAFEDS.com.
      • “Enrollees who missed a QLE deadline due to the pause on enrollments should still be able to make modifications once the enrollment pause is lifted, OPM said. Employees who are in that situation will have to call FSAFEDS at 877-372-3337 to request a change to the effective date for the QLE.
      • “Additionally, federal employees will be able to get reimbursed for any claims that were incurred after the effective date for the QLE, OPM said.
      • “OPM is also taking more long-term steps to address security concerns in FSAFEDS, including transitioning to Login.gov, the government’s platform for accessing government benefits and services online.”
    • Per Govexec,
      • “The Office of Personnel Management wants federal agencies to let it know how many senior executives, scientific/professionals and other senior-level personnel they estimate they will need for the next two years.
      • “OPM outlined its biennial review of agency executive allocations in a July 10 memorandum, calling on agency and department heads to examine their potential Senior Executive Service needs through fiscal 2026 and 2027 and how they may have changed. 
      • “The biennial review, which is required by statute, will give agencies until Nov. 22 to fully outline their anticipated SES needs, but they must also detail the projections of their position needs in their Senior Level and Scientific/Professional pay systems by Aug. 23. 

    From the public health and medical research front,

    • Beckers Hospital Review tells us,
      • “The highest numbers of breast and cervical cancer deaths are found mostly in southeastern states, according to new data from the “2024 State Scorecard on Women’s Health and Reproductive Care” released July 18 by The Commonwealth Fund.
      • “The analysis is based on 2021-22 data from publicly available sources. Learn more about the methodology here.
      • “Alabama, Arkansas, Delaware, the District of Columbia, Indiana, Kentucky, Louisiana, Mississippi, Missouri, Nevada, Oklahoma, Tennessee and West Virginia had 23.2 to 27.8 breast and cervical cancer deaths per 100,000 female population, the highest numbers in the country.”
    • The NIH Director, in her weekly blog, lets us know,
      • “Alzheimer’s disease is currently the seventh leading cause of death in the U.S. While your likelihood of developing Alzheimer’s-related cognitive impairment increases with age, risk for this disease and age of its onset depend on many factors, including the genes you carry. An intriguing new study suggests that having just one copy of a protective gene variant may be enough to delay cognitive impairment from this devastating disease in individuals who are otherwise genetically predisposed to developing early-onset Alzheimer’s dementia.
      • “The findings, from a study supported in part by NIH and reported in The New England Journal of Medicine, offer important insights into the genetic factors and underlying pathways involved in Alzheimer’s dementia. While much more study is needed, the findings have potential implications for treatments that could one day work like this gene variant does to delay or perhaps even prevent Alzheimer’s dementia.”
    • The Washington Post reports,
      • “If you want to increase your odds of living a long and healthy life, watch less television and become more physically active, because even a small amount of physical activity can improve overall health, according to an observational study published last month in JAMA Network Open.
      • “While there have been many studies showing that moderate to vigorous physical activity is associated with healthy aging, researchers wanted to know if light physical activity compared with sedentary behaviors also improves healthy aging, and if not, how can people’s time be reallocated.
      • “They found that replacing a sedentary behavior such as watching TV with even low-intensity activity — such as standing or walking around while cooking or washing clothes — increased one’s odds of healthy aging. And at work, replacing some of the time spent sitting with simple movements such as standing or walking around the office can improve health.
      • “These findings indicate that physical activity need not be high intensity to potentially benefit various aspects of health, which have especially important public health implications as older people tend to have limited physical ability to engage in moderate-to-vigorous physical activity,” Molin Wang, an associate professor in epidemiology at the Harvard T.H. Chan School of Public Health and an author of the study, wrote in an email.”
    • Per Medscape,
      • “An analysis based on a massive database of US electronic health records (EHRs) adds to evidence favoring the safety of glucagon-like peptide 1 (GLP-1) medications, finding no increased risk for many neurologic and psychiatric ailments when semaglutide was compared with other diabetes drugs.
      • “Riccardo De Giorgi, MD, DPhil, of the University of Oxford, Oxford, England, and colleagues published their research in eClinicalMedicine.”
    • Bloomberg informs us,
      • “Opioids. They’re a public-health pariah, leading to more than 80,000 overdose deaths a year. Patients worry they’ll get addicted to them. Doctors want nothing to do with them. And politicians of all stripes are calling for less dangerous options for treating pain.
      • “We are looking for absolutely anything that’s not an opioid,” says Seth Waldman, an anesthesiologist and director of pain management at Hospital for Special Surgery, a top orthopedic medicine center.
      • “Against that backdrop, the success of a safer painkiller would seem assured. A new drug, which Vertex Pharmaceuticals Inc. is developing, has been hailed as a scientific breakthrough because it treats pain without entering the brain, where opioids create addicts. The drug, suzetrigine, met its goal this year in pivotal trials for acute pain and is poised to become the first new class of pain medication in more than two decades.
      • “But all that may not be enough to loosen the grip opioids have on American medicine. Despite their dismal reputation, they have two powerful things going for them: They’re cheap, and they work. The number of opioid prescriptions has been cut by half over the past decade, but some 130 million are still doled out each year.” * * *
      • “Vertex is betting the nonaddictive properties of its drug will make it an attractive alternative to opioids. But it isn’t leaving anything to chance. Knowing it faces an uphill battle commercially, the company last year boosted its lobbying spending almost 50%, to more than $3 million. Vertex is pressing Congress for new policies that remove “structural impediments” blocking access to opioid alternatives, says Stuart Arbuckle, its chief operating officer.
      • “Vertex has scored at least one legislative victory: The No Pain Act, which goes into effect next year, provides an extra Medicare reimbursement to hospitals that prescribe alternatives to opioids. Another bill introduced this year in Congress would prohibit step therapy and limit how much Medicare patients pay out of pocket for non-opioids.
      • “Other types of new drugs face this cost hurdle, too. The rollout of new contraceptives or antibiotics has been hampered by insurers guiding doctors and patients to older, less pricey meds. The difference is that those generics haven’t been declared a public-health emergency.”
    • Mercer Consulting points out “four things employers need to know about summer heat.”
    • The New York Times reports,
      • “A daily dose of a widely used antibiotic [doxycycline] can prevent some infections with syphilis, gonorrhea and chlamydia, potentially a new solution to the escalating crisis of sexually transmitted infections, scientists reported on Thursday.
      • “Their study was small and must be confirmed by more research. Scientists still have to resolve significant questions, including whether S.T.I.s might become resistant to the antibiotic and what effect it could have on healthy gut bacteria in people taking it every day.
      • “The approach would be recommended primarily to people at elevated risk of sexually transmitted infections during certain periods, said Dr. Jeffrey Klausner, an infectious diseases physician at the University of Southern California who was not involved in the new work.
      • “The number of people who are really going to be offered this and take this is still very small,” he said. “In general, the more choices we have for people, the more prevention options we have, the better.”

    From the U.S. healthcare business front,

    • Per Fierce Pharma,
      • “GoodRx is joining forces with drugmaker Boehringer Ingelheim to make its Humira biosimilar adalimumab available at an affordable price.
      • “The pharmaceutical company will offer citrate-free adalimumab-admb at a cash price available only on GoodRx, according to an announcement. This will allow anyone with a prescription to obtain the drug at one of 70,000 pharmacies nationwide, even if they’re uninsured.
      • “Beginning on July 18, Boehringer and GoodRx will offer high-concentration and low-concentration formulas of the drug in auto-injectors or pre-filled syringes at a price of $550 per two pack. The companies said that this is a 92% discount compared to a Humira prescription.”
    • Per Beckers Hospital Review,
      • “The FDA is allowing Mark Cuban Cost Plus Drug Co. to temporarily import a syphilis drug that has been in shortage for more than a year. 
      • “Penicillin G benzathine injection fell into low supply in April 2023, and since then, clinicians have been rationing the product. In January, the FDA issued a temporary authorization for French drugmaker Laboratoires Delbert to import penicillin G benzathine. 
      • “On July 17, the FDA updated its post on the drug’s shortage. To address the scarcity, the agency cleared Cost Plus Drugs to import the medication from Laboratórios Atral.
      • “The Portugal-based drug company will export two presentations of Lentocilin (benzathine benzylpenicillin tetrahydrate), according to FDA documents.
      • “Cost Plus Drugs is selling this medication to healthcare businesses for less than $15, the company said in July 17 post on X.” 
    • Segal Consulting relates,
      • “The average stop-loss coverage premium increase is 9.4 percent for the nearly 240 health plans in Segal’s 2024 national medical stop-loss dataset.”
      • “The average includes groups that increased specific stop-loss deductible levels and/or aggregating specific stop-loss deductibles resulting in an overall reduced rate action. The average premium increase for groups that maintained similar specific stop-loss benefit levels as the prior year is 11.5 percent.”
    • Per Fierce Healthcare,
      • “Telehealth giant Teladoc is partnering with startup Brightline to extend virtual mental healthcare services for children, adolescents and their families.
      • “Through the partnership, members under the age of 18 will have access to Brightline’s behavioral health solutions through Teladoc’s virtual “front door,” the companies said.
      • “The collaboration with Brightline builds on Teladoc’s existing mental health offerings and expands access to care to members of all ages, a Teladoc spokesperson said.”
    • Beckers Hospital Review identifies seven U.S. hospitals that have received brain tumor care certification by the Joint Commission.
      • Chippenham and Johnston-Willis Hospital, Richmond, VA
      • Hackensack (N.J.) University Medical Center Hackensack
      • Jewish Hospital, Cincinnati, OH
      • Pitt County Memorial Hospital, Greenville, N.C.
      • Santa Barbara (Calif.) Cottage Hospital
      • St. Vincent Hospital and Health Care Services, Indianapolis, IN
      • Texas Health Harris Methodist Hospital – Fort Worth, TX
    • Healthcare Dive lets us know,
      • “Humana has made a minority investment in Healthpilot, a company that aims to help beneficiaries choose Medicare plans, the insurer said Wednesday. Financial terms of the deal weren’t disclosed.
      • “Healthpilot uses an artificial intelligence model to recommend Medicare Advantage, Medicare supplement and prescription drug plans based on enrollee information.
      • “Healthpilot will continue to recommend plans options from other payers following the investment, Humana said in the release. 

    Monday Roundup

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

    From Washington, DC,

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

    From the public health and medical research front,

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

    From the U.S. healthcare business front,

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

    Midweek Update

    David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Patient safety, U.S. Healthcare–

    From Washington, DC,

    • The Michael J. Fox Foundation tells us
      • “On July 2, 2024, President Biden signed the National Plan to End Parkinson’s Act into law.”
      • “Now that the bill has been signed into law, the U.S. Department of Health and Human Services (HHS) will establish the National Parkinson’s Project, a first-ever federal initiative to prevent and cure Parkinson’s disease, treat its symptoms and slow or stop its progression. It will also establish a federal advisory council that will provide recommendations and guidance for making progress against Parkinson’s disease and atypical parkinsonisms.”
    • A Labor Department press release informs us,
      • “The U.S. Department of Labor has released a proposed rule with the goal of protecting millions of workers from the significant health risks of extreme heat. If finalized, the proposed rule would help protect approximately 36 million workers in indoor and outdoor work settings and substantially reduce heat injuries, illnesses and deaths in the workplace.”  * * *
      • “The proposed rule would require employers to develop an injury and illness prevention plan to control heat hazards in workplaces affected by excessive heat. Among other things, the plan would require employers to evaluate heat risks and — when heat increases risks to workers — implement requirements for drinking water, rest breaks and control of indoor heat. It would also require a plan to protect new or returning workers unaccustomed to working in high heat conditions.” * * *
      • “Employers would also be required to provide training, have procedures to respond if a worker is experiencing signs and symptoms of a heat-related illness, and take immediate action to help a worker experiencing signs and symptoms of a heat emergency. ” 
    • An HHS press release adds,
      • “FEMA and the U.S. Department of Health and Human Services (HHS) are encouraging everyone to plan and act now to protect themselves against the dangers of heat-related illness and deaths. Extreme heat is the leading cause of death among all weather-related hazards in the U.S., but this health impact is largely preventable. The Centers for Disease Control and Prevention (CDC) estimates that at least 1,220 people in the U.S. are killed by heat events each year. Older adults, young children, and those individuals with health conditions, such as asthma or diabetes are at a greater risk for heat-related illnesses.” * * *
      • A Full List of Heat and Health Resources That Can Help: The list can be found at 2024 HHS Resources on Heat and Health – PDF.
    • The Washington Post lets us know,
      • “The Food and Drug Administration has decided to revoke its authorization for the use of a stabilizer for fruity and citrus-flavored food and beverages, known as brominated vegetable oil (BVO), because it is unsafe.
      • “The agency concluded that the intended use of BVO in food is no longer considered safe,” the agency said in a statement Tuesday. It added that based on studies conducted in collaboration with the National Institutes of Health, it found that BVO has “the potential for adverse health effects in humans.”
      • “The vegetable oil is modified with bromine, a natural chemical element that can be used as an alternative to chlorine in swimming pools and is often used as a fire retardant. It has also been used in sedatives.”
      • “BVO is an ingredient in a handful of sports drinks and sodas, but according to the FDA, “today, few beverages in the U.S. contain BVO.” Sugary soda consumption in the United States has also been falling for more than two decades. Perhaps the best-known drink in the United States that still contains BVO is Sun Drop citrus soda, as well as some store-brand orange, pineapple and citrus-flavored sodas from Giant, Food Lion, Walmart and others.”
    • Reg Jones, writing in FedWeek, discusses the leave without pay program for federal employees.
    • BioPharma Dive points out five FDA decisions that may be issued in the third quarter of 2024.
    • Federal News Network reports,
      • “With a net gain of more than 80,000 civilian employees during fiscal 2023, the federal workforce posted yet another year of growth.
      • “Between 2019 and 2023, more than 140,000 employees joined the civil service, an increase of about 7%, according to data that the non-partisan, non-profit Partnership for Public Service compiled and released this week.
      • “The majority of the growth in the past couple of years occurred in 2023 alone — the federal workforce grew by 4% in just that one year, the Partnership said. The latest increase brings the grand total of full-time federal employees to just over 2 million.
      • “These professionals play a crucial role in protecting our national security, promoting public health, driving economic development and more,” the Partnership wrote in its data report, published Monday. “They are a fundamental part of a well-functioning government.”

    From the public health and medical research front,

    • The Washington Post reports,
      • “Three years after President Biden hoped July 4, 2021, would mark the country’s independence from covid, the coronavirus is still here as new variants drive yet another summer uptick.
      • “The country is indeed free from the waves of mass death that once overwhelmed hospitals and morgues, as well as policies restricting how Americans had fun and went to school and work.
      • ‘But just as the American Revolution didn’t fully eradicate the British threat (see: the War of 1812), the coronavirus remains a public health issue, inflicting milder but disruptive illness on most people and posing a greater danger to the medically vulnerable.” * * *
      • “Experts say wastewater data is best interpreted as a way of understanding which way the virus is trending.
      • “We have consistently seen over the past three years that there is a winter surge and there is also a summer surge,” Marlene Wolfe, program director for WastewaterSCAN, a private initiative that tracks municipal wastewater data, and an assistant professor of environmental health at Emory University’s Rollins School of Public Health. “Right now, we are waiting to see whether we actually will see a downturn over the next couple of weeks and we’ve hit the peak here, or whether those levels will actually go up.”
    • GovCIO notes,
      • “Health policy officials are targeting new elements for U.S. Core Data for Interoperability (USCDI) standards to help researchers and developers speak the same language for technology around cancer care and treatment.
      • “How do we think about these additional data elements to solve particular use cases so that our federal agency partners can programmatically build on that for the programs that they have and it allows everyone to be tethered and based on what the health care delivery system already supports?” National Coordinator for Health IT Micky Tripathi, who also recently assumed a dual role as acting chief AI officer at the Department of Health and Human Services, said at a May summit.
      • “Health agencies are building a pipeline of cancer data elements for USCDI. Tripathi said ONC partners have already agreed upon the first set of data elements that aligns with reporting requirements. Agencies involved include ONC, the National Cancer Institute (NCI), the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS).”
    • STAT News discloses,
      • “A new observational study on Wednesday reported for the first time a potential link between Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy and an eye condition that can cause vision loss.
      • “After hearing anecdotes of patients on the diabetes and obesity drugs experiencing nonarteritic anterior ischemic optic neuropathy, or NAION, researchers at Massachusetts Eye and Ear analyzed data from a registry of patients at their institution to see if there was a broad trend.
      • “Among 710 patients with type 2 diabetes, there were 17 cases of NAION in patients prescribed semaglutide (the scientific name of both drugs). This translated to a cumulative rate of 8.9% over three years. That compares with six cases in patients prescribed non-GLP-1 diabetes drugs, calculated as a cumulative rate of 1.8%. Through statistical analyses, the researchers estimate that there was a 4.28 times greater risk of developing the condition in patients prescribed semaglutide, according to the study, published in JAMA Ophthalmology.
      • “Studying 979 patients who had overweight or obesity, researchers found 20 cases of NAION in people prescribed semaglutide, calculated as a cumulative rate of 6.7%. In comparison, there were three cases in people prescribed non-GLP-1 obesity drugs, calculated as a cumulative rate of 0.8%. The researchers estimate that there was a 7.64 times greater risk of developing the condition in patients prescribed semaglutide.”
    • Per a National Institutes of Health press release,
      • “Results from a large study supported by the National Institutes of Health show that protein analyses taken during the first trimester of pregnancy did not improve predictions for identifying people at risk for experiencing conditions related to having high blood pressure during pregnancy. Since there is an urgent need to better predict people at risk for developing conditions related to having high blood pressure during pregnancy, also called hypertensive disorders of pregnancy, researchers have been studying if proteins taken from blood or urine samples could provide this insight. This study provides the largest data to date based on using protein analyses from blood samples during early pregnancy.
      • “For this study, researchers analyzed 6,481 proteins from 1,850 study participants who had a first pregnancy between 2010 and 2013. Participants provided a blood sample during the study enrollment and had study check-ins during their second and third trimesters, after delivery, and two to seven years after their pregnancy. The protein analysis was used in different modeling equations to assess if proteins or their combinations with clinical data, such as maternal age and cardiovascular disease risks, during early pregnancy could provide clues for the 753 participants who experienced a hypertensive disorder of pregnancy. The conditions assessed included gestational hypertension, marked by high blood pressure that typically develops after 20 weeks of pregnancy, and preeclampsia, a significant rise in blood pressure after 20 weeks of pregnancy that can damage organs and is marked by elevated levels of protein in the urine.
      • “The prediction models, which included three different types of assessments, did not significantly improve risk predictions for these events. If the models did show predictive ability, they did not drastically improve criteria physicians currently use to assess risks. These criteria currently include risk factors such as having obesity, diabetes, high blood pressure, or a baby later in life.”
    • The NEJM Catalyst offers an article
      • “highlight[ing] the persistent challenges and opportunities surrounding the impact of value-based care (VBC) arrangements on patient safety, despite the widespread adoption of VBC models. In the context of recent declines in patient safety, the authors contend that this crucial component of health care value has not received sufficient attention in most VBC contracts.
      • “The authors propose strategies for how payers can integrate patient safety measures into VBC contracts and align financial incentives with quality performance, drawing on the example of Elevance Health’s initiative, the Quality-In-Sights: Hospital Incentive Program. In this program, patient safety measures comprise 80% of the overall score.
      • “The program suggests that a sustained and productive collaboration between payers and providers offers potential for integrating patient safety measures into VBC models to drive clinical improvements and financial efficiencies, but it requires commitment from all stakeholders in the health care ecosystem.”
    • Per MedPage Today,
      • “E-cigarette use among individuals eligible for [USPSTF recommended] lung cancer screening was independently associated with a reduced likelihood of screening, a cross-sectional study of U.S. adults revealed.” * * *
      • “Former smokers who use e-cigarettes remain at increased risk of lung cancer and should be targeted by interventions to improve adherence to LCS [lung cancer screening],” Wang and co-authors concluded.”

    From the U.S. healthcare business front,

    • STAT News reports,
      • “More than two dozen Medicare Advantage insurers received higher quality marks for 2024, based on a STAT review of new data released July 2 by the federal government.
      • “Ten health insurance companies, including UnitedHealth Group’s UnitedHealthcare and CVS Health’s Aetna, received critical upgrades in some of their offerings that will allow them to earn hundreds of millions of dollars in extra taxpayer-funded bonuses.”
    • Beckers Payer Issues offers more details on the plans that got a boost to five stars due to the CMS action.
    • Beckers Payer Issues also informs us,
      • “Walmart has held talks with Humana about a potential sale of its shuttered Walmart Health clinics, Fortune reported July 2. 
      • “Multiple sources familiar with the situation told Fortune that Walmart has held discussions with potential buyers for its clinics, including Humana, the only potential buyer named in the report. It is unclear if talks are ongoing, according to the publication.”
    • The Wall Street Journal reports,
      • “GSK struck a deal to buy the rights to CureVac’s CVAC -6.59%decrease; red down pointing triangleCovid-19 and flu vaccines for up to 1.45 billion euros ($1.56 billion), in a bid to regain ground lost to newcomers to the vaccine market during the pandemic.
      • “The deal bolsters the U.K. pharmaceutical company’s vaccine portfolio at a time when bird-flu concerns are boosting demand. Vaccines accounted for roughly a third of GSK’s sales last year.
      • “GSK’s deal with CureVac follows in the footsteps of a vaccine licensing agreement between Sanofi and Novavax in May valued at up to $1.4 billion.
      • “Both GSK and Sanofi were among the biggest makers of vaccines before the pandemic, but fell behind rivals and new entrants that launched shots based on messenger RNA, or mRNA, technology as Covid-19 turbocharged demand. The mRNA-based vaccines that were widely used to combat Covid-19 use messenger ribonucleic acid instead of an actual bacteria or virus in the production process.”
    • Plan Advisor lets us know,
      • “Many employers are spending money on benefits that do not match the objectives of their workforce, based on a recent survey by Payroll Integrations, which connects payroll provider programs with employers.
      • “According to Payroll Integrations’ recent survey, summarized in the 2024 State of Employee Financial Wellness Report, only 18% of workers expressed interest in the programs their employers are now funding. While 41% of employers indicated they intend to increase their spending on financial education and planning services, workers would rather see their employers make larger investments in retirement plans (43%) and health insurance (54%).
      • “Employees are feeling the financial pressure from inflation, higher costs of living and the rise of insurance costs and now, more than ever, employers feel a responsibility to step in to help support their financial well-being,” said Doug Sabella, Payroll Integrations’ CEO, in a release that accompanied the report. “But there’s a clear disconnect between what employers think employees want in terms of financial wellness offerings and benefit programs and what employees feel they need to make a difference.”
      • “While workers in Generation Z want their companies to make lifestyle benefits top priority, older generations place more emphasis on health care and retirement, Payroll Integrations found. Baby Boomers ranked pensions as the most essential benefit, Gen X and Gen Y workers selected additional compensation, Millennials prioritized health savings accounts, and Gen Z employees picked lifestyle compensation.”

    Midweek Update

    David Ermer–ACA, Congress, FDA, Federal employment benefits, Medical / Rx research, SDOH, U.S. Healthcare–
    Photo by Manasvita S on Unsplash

    From Washington, DC

    • Beckers Payer Issues reports,
      • “Making expanded ACA subsidies permanent would add $335 billion to the national deficit between 2025 and 2034, the Congressional Budget Office estimated. 
      • “Premium tax credits have spurred record enrollment in ACA marketplace plans. These subsidies, implemented in 2021, are set to expire at the end of 2025 unless Congress votes to extend them. 
      • “In a June 24 letter to the chairs of the House ways and means and budget committees, the CBO estimated making subsidies permanent would cost $415 billion overall — the result of a $250 billion increase in spending and a $164 billion decrease in tax revenue. 
      • “These costs would partially be offset by a decline in offers of employment-based insurance, the CBO estimated, resulting in a total add of $335 billion to the budget.  * * *
      • “Payer executives have told investors they are optimistic Congress will cut a deal to extend the subsidies or make them permanent.”
    • Fierce Healthcare tells us,
      • “A leading Democrat and health legislator is urging the Centers for Medicare & Medicaid Services (CMS) to better enforce Medicare Part D program requirements for pharmacy benefit managers.
      • “By evading such requirements, PBMs are threatening the financial health of the country’s smaller pharmacies, Senate Finance Committee Chair Ron Wyden, D-Oregon, wrote to the agency in a letter (PDF).
      • “I am alarmed to hear reports that PBM contracting practices are straining the finances of pharmacies and directly contributing to their closures,” he said. “Specifically, I am concerned PBMs are not adhering to the new rule reining in direct and indirect remuneration (DIR) fees that took effect on January 1 and undermining Medicare’s pharmacy access standards as intended by Congress.”
    • The National Academies of Sciences, Engineering, and Medicine released a report titled “Ending Unequal Treatment: Strategies to Achieve Equitable Health Care and Optimal Health for All” which follows up on a well-known 2003 report on social determinants of health.
    • Per an FDA press release,
      • “Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. * * *
      • “Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov. All written comments should be identified with the docket number and with the title of the guidance document.”
    • Federal News Network informs us,
      • “For more than a week, federal employees enrolled in FSAFEDS have not been receiving payments for approved reimbursement claims made in their Flexible Spending Accounts.
      • “The program suspended all reimbursement payments beginning June 16 as an effort to further strengthen anti-fraud and security measures, Federal News Network confirmed with a government source who explained the issue on the condition of anonymity.
      • “At this time, the FSAFEDS is holding all claims payments out of an abundance of caution,” FSAFEDS wrote Tuesday in a post on X. “FSAFEDS has taken this action due to recently discovered fraudulent claims activity. We are working to resolve and restore all claims payment activities as soon as possible.”
      • “The pause on reimbursement payments, however, has been lifted and payments to employees should resume soon, Federal News Network has learned. FSAFEDS plans to process all reimbursements currently on hold by the end of the week.

    From the public health and medical research front,

    • MedPage Today tells us,
      • “All adults ages 75 years and older should receive a single dose of any respiratory syncytial virus (RSV) vaccine, and adults ages 60 to 74 years who are at increased risk of severe RSV disease should receive a vaccine, according to a unanimous 11-0 vote by the CDC’s Advisory Committee on Immunization Practices (ACIP).
      • “Also, people who have already received the RSV vaccine are not recommended to receive a booster, based on data that showed another dose did not improve outcomes.
      • “These recommendations supplant the current recommendation that adults ages 60 and older may receive RSV vaccination after engaging in shared clinical decision-making with their healthcare provider.
      • “There are currently three RSV vaccines available for use in older adults — GSK’s adjuvanted RSV prefusion F protein-based vaccine (Arexvy) Pfizer’s unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo), and Moderna’s mRNA-1345 vaccine (mRESVIA).
    • The American Hospital Association News notes,
      • “The Administration for Strategic Preparedness and Response June 25 announced a flu pandemic preparedness and response strategy in response to the threat of H5N1 bird flu in humans. The strategy, released through ASPR’s Biomedical Advanced Research and Development Authority, has four objectives: strategic implementation and deployment of the national pre-pandemic influenza vaccine stockpile; enhanced protection through novel vaccines; leverage therapeutics through deployment, early availability and development of novel products; and ensure rapid and effective diagnostics tools to inform rapid antiviral prescription and treatment.” 
    • BioPharma Dive calls attention to the fact “Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help? There are no drugs specifically for polycystic ovary syndrome, a chronic condition that can cause infertility. One study is testing whether Wegovy might be beneficial.”
    • Per Fierce Pharma,
      • “[Verona Pharma’s] Ohtuvayre [which the FDA approved for marketing today] becomes the first novel treatment advance in more than a decade for COPD, an inflammatory condition which restricts airflow from the lungs and leaves patients struggling to breathe. Ohtuvayre is approved as an add-on medicine with current therapies.
      • “As a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, Ohtuvayre combines two properties in one medicine, setting it apart in COPD for its ability to both open the airways of patients and reduce their inflammation.
      • “It’s really the first novel mechanism as an inhaled therapy in over 20 years for COPD,” David Zaccardelli, Verona’s CEO said in an interview with Fierce Pharma. “We believe its bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm.”
    • The Washington Post reports,
      • “A few of your favorite ice cream products might no longer be in the freezer this summer after a prominent supplier to brands such as Hershey’s and Friendly’s issued a recall notice over a potential listeria contamination.
      • “Maryland-based Totally Cool recalled products from 13 brands distributed nationwide in retail locations and through direct delivery after sampling by the Food and Drug Administration discovered the presence of Listeria monocytogenes, the bacterium that causes listeria infections, the agency said Monday.
      • “The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets, according to a list published by the FDA that includes expiration dates.”

    From the U.S. healthcare business front,

    • Kaufmann Hall discusses the state of play in healthcare antitrust enforcement.
    • The Wall Street Journal predicts “The War Over Cheaper Ozempic Won’t End Well for Some Investors. Once Eli Lilly and Novo Nordisk increase supply of weight-loss medications, companies such as Hims & Hers may find it trickier to sell compounded versions of the drugs [due to the nuances of FDA law.]”
    • MedTech Dive points out “Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech. Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.”
    • Per Fierce Healthcare,
      • “Blue Shield of California is making it easier for members to access their personal health data through its new Member Health Record.
      • “The platform will combine health data both from claims as well as from providers in one place and is available both online and through Blue Shield’s app so members can connect virtually. The Member Health Record will first launch for a “select group” of Medicare Advantage members and will be rolled out to all of its members by the end of the year.
      • “The health record will include information on lab results, immunizations, diagnoses and conditions alongside historical health data that have been shared with the plan, including details tallied before the member joined Blue Shield.”

    Tuesday Tidbits

    David Ermer–AHRQ, CDC, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–
    Photo by Patrick Fore on Unsplash

    From Washington, DC,

    • KFF Health News reports,
      • “U.S. Surgeon General Vivek Murthy declared firearm violence a public health crisis, as gun deaths and injuries punctuate daily life in America.
      • “On nearly every day of 2024 so far, a burst of gunfire has hit at least four people somewhere in the country. Some days, communities have endured four or five such shootings.
      • “The nation’s top doctor called on policymakers to consider gun safety measures such as bans on assault weapons and high-capacity ammunition magazines and universal background checks for all firearm purchases. His advisory also urges a “significant increase” in funding for research on gun injuries and deaths, as well as greater access to mental health care and trauma-informed resources for people who have experienced firearm violence.”
    • NPR discusses what the declaration will do.
    • The U.S. Public Health Service Task Force issued a draft recommendation today which “concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.” The public comment period ends on July 22, 2024.
    • Reg Jones, writing in FedWeek, explains “Earning, Accumulating and Using Sick Leave in the Federal Government.”

    From the public health and medical research front,

    • The Washington Post reports,
      • “The Centers for Disease Control and Prevention warned clinicians, health authorities and the public Tuesday about an increased risk for dengue virus infections in the United States because of the record-breaking global incidence of the mosquito-borne viral disease.
      • “In the first six months of 2024, countries in the Americas have reported more than 9.7 million dengue cases, twice as many as in all of 2023, exceeding the highest number ever recorded in a single year, the CDC said in a health advisory. Puerto Rico declared a public health emergency because of the unusually high number of cases reported in the winter and spring, the dry season, when dengue cases are typically low.
      • “Since January, 745 dengue cases have been identified among U.S. travelers who became infected abroad, the agency said. Dengue cases typically increase during the warmest months that are yet to come. Last year, there were 1,829 travel-associated cases in the U.S. * * *
      • “With increased global and domestic incidence of dengue, the CDC is urging health-care providers to be on the lookout for dengue among people with fever who have been in areas with dengue transmission within 14 days of the start of illness. Infants, pregnant people, adults over 65 years old and people with certain medical conditions are at increased risk for severe dengue.”
    • Beckers Hospital Review lets us know,
      • “Teva Pharmaceuticals is launching the first authorized generic of Victoza, the first generic GLP-1 product available in the United States.
      • “By launching an authorized generic for Victoza (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva, said in a June 24 news release.”
    • Highlighting the importance of a generic GLP-1 product is this Wall Street Journal article reporting that
      • “Blockbuster obesity drug Wegovy has been approved in China, opening the door for maker Novo Nordisk to begin selling it in the world’s second-largest economy, where the appetite for similar treatments is surging. * * *
      • “Novo Nordisk’s Ozempic drug—which contains the same semaglutide active ingredient as Wegovy—was approved to treat diabetes in China in 2021. Sales of the drug in the country more than doubled on year in 2023, reaching 4.82 billion Danish kroner ($693.6 million).
      • “Demand for weight-loss drugs is surging in China, where the proportion of overweight and obese adults reached almost 51% in 2022, creating a frenzy among local manufacturers to develop their own versions of the popular treatments, especially as Novo Nordisk’s semaglutide patent expires there in 2026, which will pave the way for generic versions.”
    • MedPage Today notes,
      • “Disrupted circadian rhythms in cognitively normal adults were tied to higher subsequent amyloid-beta levels, prospective data showed.
      • “Higher daily variability at baseline — an indicator of fragmented 24-hour activity rhythms — was associated with higher PET amyloid burden 8 years later (β=0.15, P=0.02) after adjusting for age, sex, APOE4 status, and other factors, according to Julia Neitzel, PhD, of Erasmus University Medical Center in Rotterdam, the Netherlands, and co-authors. * * *
      • “Considerable interest surrounds the role of sleep dysfunction in the development of Alzheimer’s disease and dementia,” observed Matthew Pase, PhD, of Monash University in Victoria, Australia, who wasn’t involved with the study.
      • “If poor sleep contributes to dementia, improving sleep symptomatology could be one strategy to lower dementia risk,” he told MedPage Today.
    • NPR discusses why “Your gut microbes may influence how you handle stress.”

    From the U.S. healthcare business front,

    • Beckers Hospital Review reports,
      • “The University of Alabama System’s board of trustees unanimously approved an agreement to acquire Ascension St. Vincent’s Health System.
      • “Birmingham-based UAB will assume ownership of all Ascension St. Vincent’s care sites under the agreement, announced June 25. The transaction still needs approval from federal regulators and the Catholic Church. UAB and Ascension expect the $450 million deal to close in the fall of 2024, according to the Shelby County Reporter.
    • and
      • identifies the twenty most socially responsible hospitals in the U.S., per Lown Institute. Duke Regional Hospital, in Durham, NC, leads the pack.
    • Per Fierce Pharma,
      • “Physicians don’t mind patients choosing at-home testing options over coming in for an in-person clinic visit—in fact, they overwhelmingly support it, according to the results of a new survey.
      • “Ixlayer’s report this week is based on a poll of more than 140 U.S. physicians representing a variety of specialties. All together, nearly 90% agreed that at-home tests are more convenient to many patients and can improve access to diagnostic care, and almost as many said they believe offering at-home testing options can help speed up diagnoses and, ultimately, improve patient outcomes.
      • “There is a large subset of my patients where making routine office visits is difficult, either complicated by age, travel time, costs, or time constraints. So I see having a convenient, at-home solution as a plus for improving medical care,” one of the survey’s respondents said.
      • “The overwhelming majority of the doctors surveyed, 91% of the group, said they were open to providing at-home testing kits to their patients, and 80% agreed that the remote tests could support or even enhance the healthcare system’s existing workflows.