Monday Roundup

Obesity

Monday Roundup

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

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

From Washington, DC

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

From the public heal

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

From the U.S. healthcare business front,

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

Monday Roundup

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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


Friday Factoids

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

David Ermer–CDC, Congress, Medical / Rx research, NCQA, Obesity, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • [On Monday July 21, the House of Representatives passed] “the Billion Dollar Boondoggle Act, was already approved by the Senate in March. 
    • “It would require agencies to report annually to Congress about their projects that are more than five years behind schedule or are $1 billion or more over budget. 
    • “Specifically, the measure would require an explanation for the delay or cost increase as well as a justification for any award, incentive fee or other type of bonus awarded with respect to the project. 
    • “It’s a bad day for boondoggles, but a very good one for taxpayers!” bill sponsor Sen. Joni Ernst, R-Iowa, said in a statement following House passage.” 
  • and
    • “The House also cleared the GOOD Act, which would mandate agencies to post their guidance documents online in a single location on the day they are issued. 
    • “Unfortunately, agency guidance documents are difficult to find, leaving Americans and small businesses guessing, and oftentimes struggling, to comply with the law. The Guidance Out of Darkness Act rights this wrong by requiring federal agencies to be transparent about interpretations of the law through publishing guidance in an easily accessible, online location,” said House Oversight and Accountability Chairman James Comer, R-Ky., who also sponsored the bill, in a statement. “Laws should not be implemented based on guidance that’s kept in the dark.”
    • “It also would require agencies to publish previously issued guidance documents that are still in effect to the same website.”
    • This bill now goes to the Senate for consideration.
  • Govexec also informs us,
    • “The Office of Personnel Management on Thursday finalized new regulations intended to ensure that federal workers who are temporarily promoted are paid appropriately for the duration of their detail.” * * *
    • “The new rule will go into effect on Aug. 26. In a memo to agency HR directors, OPM Associate Director for Workforce Policy and Innovation Veronica Hinton sought to reassure agencies that the new rule only applies in certain circumstances, providing an FAQ on the issue.”
  • The Washington Post tells us,
    • “A Senate committee Thursday formally opened a bipartisan investigation into Steward Health Care, the nation’s largest physician-led hospital system, and voted to subpoena the company’s CEO, alleging that Steward executives had mismanaged the system’s finances and put patient care at risk.
    • “Steward, a for-profit company that owns 31 hospitals across the country, is in bankruptcy proceedings and has been seeking to sell its hospitals. Community leaders and health workers in states served by Steward’s facilities, such as Massachusetts, have blamed Steward leaders for extravagant paydays even as hospitals struggled to meet mortgage payments and cover other expenses. The Justice Department also has been probing the company over allegations of fraud.”
    • “Senators on the Health, Education, Labor and Pensions Committee echoed those concerns Thursday and said Steward warranted a national spotlight on Capitol Hill, accusing the hospital system’s leaders of “outrageous corporate greed” that harmed access to medical services, such as spending nearly $100 million on a pair of private jets. Lawmakers on the committee have been investigating the system for months.”

From the public health and medical research front,

  • The Washington Post relates,
    • “A twice-yearly injection could help prevent HIV infections, according to the results of a new study described by medical experts as a breakthrough.
    • “In a randomized trial involving more than 5,000 young women and girls in South Africa and Uganda, none of those who received the prevention shots contracted HIV. The results were published in the New England Journal of Medicine on Wednesday.
    • “This appears to be a new breakthrough for HIV prevention. If these injections can be widely distributed at low cost, it would dramatically reduce the risk of new HIV infections worldwide,” said Sarah Palmer, co-director of the Center for Virus Research at the Westmead Institute for Medical Research in Sydney, who was not involved in the peer-reviewed study. “It is especially encouraging this research focused on young women in Africa who are so highly at-risk for HIV infection.” * * *
    • “The shots were produced by drugmaker Gilead Sciences, which funded the trial, and some of the researchers were Gilead employees. Lenacapavir, sold under the brand name Sunlenca, is approved as a treatment for HIV infections in the United States. The goal of the trial was to prove its safety and efficacy for the prevention of infection in adolescent girls and young women. A separate trial for men is underway.”
  • ‘The New York Times reports,
    • “For the more than 310,000 women diagnosed with breast cancer every year, no matter how well the treatment goes, there is always a lingering fear. Could the disease come back, even years later? And what if it comes back in the other breast? Could they protect themselves today by having a double mastectomy?
    • “A study has concluded that there is no survival advantage to having the other breast removed. Women who had a lumpectomy or a mastectomy and kept their other breast did just as well as women who had a double mastectomy, Dr. Steven Narod of Women’s College Hospital in Toronto and his colleagues reported, using U.S. data from more than 661,000 women with breast cancer on one side.
    • “In the study, published in JAMA Oncology on Thursday, the researchers added that most women did very well — the chance of cancer in the other breast was about 7 percent over 20 years.
    • “But the study’s results may not apply to women who have a gene variant, BRCA1 or BRCA2, which greatly increases their cancer risk. For the 1 in 500 American women with this variant, cancer researchers agree that it’s worth considering a double mastectomy.” * * *
    • “Dr. Angela DeMichele, a professor of medicine and co-leader of the breast cancer program at the University of Pennsylvania “says she carefully explains to patients that they have a real choice in treatment — they don’t have to have a double mastectomy.
    • “Many women, she said, assume that the more surgery they have, the more likely they are to be cured. So, they want both breasts removed.
    • “She tells them that removing the second, healthy breast does not prevent cells from their newly diagnosed cancer from spreading to other organs and to bones. “That is why chemotherapy and hormonal therapies are so important,” she tells patients. “They are designed to kill these cells.”
  • Per Beckers Hospital Review,
    • “A newly tested combination therapy showed a higher rate of survival compared to chemotherapy alone, according to a study published July 24 in The New England Journal of Medicine.
    • “Researchers from academic institutions including Mayo Clinic in Rochester, Minn., and the Dana-Farber Cancer Institute in Boston, conducted a clinical trial testing the combination therapy of blinatumomab plus chemotherapy on the survival rates of patients with B-cell precursor acute lymphoblastic leukemia.” * * *
    • “These results are encouraging and establish a new standard of treatment for people with BCP-ALL. The addition of blinatumomab to chemotherapy reduced the risk of leukemia recurrence and death by nearly 60%,” Mark Litzow, MD, lead study author and hematologist at the Mayo Clinic Comprehensive Cancer Center, said in a July 24 news release from the Mayo Clinic.” 
  • and
    • “About 28% of knee and hip replacements are performed on people younger than 55 and the trend is expected to grow, U.S. News & World Report reported July 24.
    • “By 2030, people younger than 65 are expected to account for 52% of hip replacements and 62% for total knee replacements, according to research presented at the American Academy of Orthopedics’ annual meeting in 2023. Researchers utilized data from 5,153 patients in the American Joint Replacement Registry that had a total hip arthroplasty performed between 2012 and 2020.
    • “Many of those younger adults are former athletes.”
  • The American Medical Association lets us know what doctors wish their patients knew about pink eye.
  • The Hill notes,
    • “Teen births declined 69 percent from 2000 to 2022, according to newly released federal data, but racial and ethnic disparities continue to exist.  
    • Births declined at similar rates across all races, but Black, Native American and Hispanic teenagers still had higher birth rates in 2022 than white, non-Hispanic teens, according to the data from the Centers for Disease Control and Prevention. 
  • U.S. News and World Report adds,
    • “For the first time in two decades, the infant mortality rate in the United States has risen, new government data shows.
    • “In a report released Thursday by the U.S. Centers for Disease Control and Prevention, researchers found that more than 20,500 babies died in 2022 before the age of 1. Overall, there were 5.6 infant deaths for every 1,000 live births, a 3% increase from the year before.
    • “Infant health is one of the most important public health indicators that we have,” Amanda Jean Stevenson, a demographer and assistant professor of sociology at the University of Colorado Boulder, told CNN.
    • “The fact that [infant mortality rates] are not continuing to decrease is a very big deal. Even flat infant mortality rates are not good,” she added. “We need to see these numbers going down — and fast — because they are far too high.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Hospitals are finally emerging from the pandemic’s lasting disruption to labor markets, adding nurses and other critical workers who left the market or job hopped for higher pay. 
    • “HCA Healthcare and Tenet Healthcare, two of the nation’s largest hospital and surgery-center companies, reported this week their hospitals are busy and are expected to stay that way through the year. Hiring has opened up services they had closed because of the pandemic and a tight labor market, company executives say.
    • “In totality, the strength in the hospital segment has been significant,” said Dr. Saum Sutaria, Tenet’s chief executive, on a call with analysts after the company posted its earnings this week. “We feel optimism about the demand that we see.”
  • In that regard, Healthcare Dive points out,
    • “Tenet Healthcare reported second-quarter earnings Wednesday that beat analysts’ estimates, drawing in a net income of $259 million on strong demand for outpatient services. 
    • “The Dallas-based provider raised its full-year guidance again following the results. Tenet was the only major for-profit provider to raise its full-year forecast following first-quarter earnings.
    • “Tenet now expects to bring in $3.8 billion to $4 billion in adjusted earnings before interest, taxes, depreciation and amortization — a $300 million increase over previous projections.” 
  • and
    • “Universal Health Services posted a second quarter net income of $289.2 million on Thursday and modestly revised its full-year revenue guidance up by 0.3% to 1%.
    • “However, CFO Steve Filton said on the company’s earnings call that acute care hospitals experienced a “moderation of demand” for services during the quarter, with adjusted admissions increasing 3.4% year over year and surgical growth “flattening out.” 
    • “The King of Prussia, Pennsylvania-based health system reported progress on controlling expenses — notably physician fee costs, which have plagued the system for multiple quarters. Executives called further cost controls critical to UHS’ efforts to get back to pre-pandemic operating margins.”
  • Per Beckers Hospital Review,
    • “St. Louis-based Ascension has taken another step in its effort to reorganize its portfolio — a strategy designed to enhance operating performance and ensure sustainability.
    • “The latest transaction is in the Midwest. Ontario, Calif.-based Prime Healthcare has entered into an asset purchase agreement with Ascension to acquire hospitals and care sites in Illinois.”
  • and
    • “Optum is closing clinics in multiple states and laying off 524 employees across California.
    • “According to regulatory documents filed July 18, the UnitedHealth Group company will terminate the California employees from Sept. 16 through January 2025 at clinic and administrative office locations in Hayward, Glendora, Montbello, Covina, Pasadena, Long Beach, Los Angeles, Irvine, Beaumont, Redlands, Highland, El Segundo, and Cerritos. The layoffs include some remote employees in other states.”
  • Healthcare Dive further notes,
    • “Investors came into second-quarter earnings for Molina concerned about how challenges in its core Medicaid business might affect the insurer. However, Molina exceeded Wall Street’s expectations for earnings and revenue in finances released aftermarket Wednesday.
    • “Molina reported revenue of $9.9 billion, up almost 19% year over year thanks to the insurer winning new Medicaid contracts and growing its existing businesses. Net income of $301 million was down slightly year over year due to an increase in spending on Medicaid beneficiaries, but still better than analyst forecasts.
    • “Medicaid pressures should ameliorate over the back half of the year, Molina executives told investors on a Thursday morning call. Molina is also open to additional M&A, despite coming off two recent acquisitions, and plans to stand up a new business to oversee its growth strategy in dual-eligible Medicare and Medicaid plans.”
  • Per Beckers Payer Issues,
    • “CareFirst Blue Cross Blue Shield credits a critical partnership with achieving top-tier results for Type 2 diabetes care. 
    • “CareFirst partnered with Ryse Health, a chain of clinics in the Washington, D.C. and Baltimore areas, focused exclusively on managing diabetes. CareFirst members who received care at Ryse Health clinics had, on average, scores in the 95th percentile for several HEDIS measures.
  • and
    • “UnitedHealth Group will invest $25 million for housing for veterans experiencing homelessness and low and middle-income individuals. 
    • “The grant will go to the Community Solutions Large Cities Housing Fund, a $135 million fund backed by Kaiser Permanente, Wells Fargo and other large donors. The fund directly acquires apartment units. Half of these units are reserved for individuals transitioning out of homelessness, including veterans, according to a July 24 news release.” 
  • Per BioPharma Dive,
    • “Viking Therapeutics shares soared by more than 30% early Thursday after the company told investors it’s moving an experimental obesity drug into Phase 3 testing earlier than expected and exploring more convenient dosing.
    • “The medicine, dubbed VK2735, has already shown promising results in a Phase 2 trial released in February. In that study, patients lost as much as 15% of their body weight after 13 weeks of treatment with the drug, findings that suggest Viking’s option might be a future threat to blockbuster obesity medications sold by Novo Nordisk and Eli Lilly.
    • “Analysts expected the next step would be a Phase 2b trial. But late Wednesday, Viking said it’s moving directly to Phase 3 after a meeting with Food and Drug Administration officials. The company also plans to study monthly injections for the medicine, potentially offering another advantage over the once-weekly products available now.”
  • and
    • “Roche is best known for the cancer drugs that still account for much of its drug revenue. But the Swiss pharmaceutical giant spent much of its latest quarterly earnings call fielding questions about a pair of experimental weight loss medicines that have fast become important to its future growth.
    • “Roche last year acquired those medicines in a $2.7 billion deal for biotechnology company Carmot Therapeutics. One, CT-388, is an injectable therapy, while the other, CT-996, is a pill. Since May, both have since shown the potential in early trials to spur significant weight loss, adding billions to Roche’s market value and making the company a surprise player in one of the most lucrative areas of drug research.
    • “It’s going to be a huge market,” CEO Thomas Schinecker said on a conference call. “By 2035, about 50% of the world’s population will be obese.”


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. 

Midweek Update

David Ermer–AHRQ, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal adds,
    • “A summer Covid wave is hitting the country, but there’s one consolation: Your chances of developing long Covid have fallen since the start of the pandemic. 
    • “That’s the finding from a new study in the New England Journal of Medicine. It concluded that about 10% of people infected with the virus’s original strain developed long Covid. By contrast, the risk of developing long Covid dropped to 3.5% with the virus’s Omicron variant among vaccinated people. For the unvaccinated, the risk was 7.7.%.
    • “Researchers defined long Covid as people who experienced persistent and debilitating symptoms such as a racing heartbeat or brain fog, or other new health problems linked to the initial illness, a month or more after their infection.
    • “About 70% of the drop in long Covid cases was due to vaccination and 30% because of changes in the virus itself, the study determined. 
    • “Four years since the start of the pandemic, we’re getting used to periodic waves of Covid cases, including the uptick we’re seeing now, driven by Omicron subvariants. The threats of severe illness and lingering health problems have significantly subsided, though they haven’t disappeared.”
  • Beckers Hospital Review reports,
    • “As the House Committee on Oversight and Accountability investigates pharmacy benefit managers regarding alleged anticompetitive practices, the committee scheduled a hearing with leaders of the top three PBMs. 
    • “On July 23, [at 10 am ET], members of the House Committee on Oversight and Accountability plan to ask executives at Express Scripts/Evernorth, CVS Caremark and OptumRx about the alleged anticompetitive policies, which committee members say raise prescription drug costs, harm independent pharmacies and obstruct patient care. 
    • “The three PBMs account for about 80% of the market share. 
    • “The called witnesses are Adam Kautzner, PharmD, president of Evernorth Care Management and Express Scripts; David Joyner, executive vice president of CVS Health and president of CVS Caremark; and Patrick Conway, MD, CEO of OptumRx.”
  • The FEHBlog discovered today that on July 11, 2024, Rep. Gary Palmer (R Ala.) introduced House Jt. Resolution 187 which reads,
    • “Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That Congress disapproves the rule submitted by the Office of Personnel Management relating to Postal Service Reform Act; Establishment of the Postal Service Health Benefits Program (89 Fed. Reg. 37061), and such rule shall have no force or effect.”
  • The cited rule is the OPM’s May 2024 supplemental rule implementing the PSHBP. In the FEHBlog’s opinion, the provision of the rule which offends Rep. Palmer (and the FEHBlog) for that matter is found in an OPM FAQ:
    • “While the proposed rule reflects that Medicare Part D-eligible annuitants and their Part D-eligible family members would be automatically group enrolled into the Part D EGWP, it reflects that they may choose to opt out of receiving prescription drug coverage through the PSHB Part D EGWP. This proposed rule provides, consistent with the statute, that the Part D EGWP offered by their PSHB plan is the only PSHB prescription drug benefit available for Part D-eligible PSHB annuitants and their Part D-eligible covered family members. As proposed, Medicare Part D-eligible annuitants and their family members who choose to opt out of or disenroll from the PSHB plan’s Part D EGWP would not have access to prescription drug benefits through their PSHB plan and would not pay a lower premium than those enrolled in the Part D EGWP.“
  • Nothing in the Postal Service Reform Act suggests that Congress intended to impose such a penalty. It’s a penalty because OPM does not reduce the premium for members who are deprived of their plan’s prescription drug benefits. Furthermore, when Congress included a mandate for PSHBP annuitants to enroll in Part B, it also provided grandfathering protections and exemptions. The Part D penalty applies across the board.
  • In any case, because Part D benefits will feature improvements such as a $2,000 out of pocket cost maximum for 2025, the carrot approach to incenting Part D EGWP enrollment should be tried first.
  • The American Hospital Association News lets us know,
    • “The Administration for Strategic Preparedness and Response July 16 announced it will work with the Department of Commerce on an assessment of the active pharmaceutical industrial base to better understand the pharmaceutical supply chain and how it has changed since the COVID-19 pandemic. The assessment is based on a survey conducted last winter. The study will inform federal strategies and funding decisions related to the API supply chain and raise awareness of potential supply chain issues, such as the current limited domestic manufacturing capabilities and other potential issues. The study will survey more than 200 companies, including manufacturers, distributors, suppliers and customers. A Bureau of Industry and Security webpage answers FAQs about the project.”

From the public health and medical research front,

  • STAT News tells us,
    • “The Centers for Disease Control and Prevention just released a trove of data on Americans with disabilities that found that more than a quarter of U.S. adults have a disability — over 70 million people, a bump from prior years. This slice of the population was also much more likely to report long Covid symptoms such as chronic fatigue and brain fog. This comorbidity looms large for many disabled communities as another surge in Covid cases sweeps the country.
    • “The data, gathered in 2022, is part of the agency’s Disability and Health Data System, which has annual state and national-level data stretching back to 2016. This is the first year that the agency has released long Covid data, finding that 11% of people with disabilities had long Covid symptoms while only 7% of people without disabilities reported symptoms.
    • “For many disabilities, the highest populations exist in a swath that extends from the Deep South and Louisiana up to Appalachian communities in West Virginia and Ohio. Disability benefits claims are typically highest in these areas, but for long Covid, the geography shifted west. Idaho and other states along the Continental Divide saw much higher rates of symptoms, with Montana recording the highest prevalence at 18%.”
  • The New York Times adds,
    • “A large new study provides some of the strongest evidence yet that vaccines reduce the risk of developing long Covid.
    • “Scientists looked at people in the United States infected during the first two years of the pandemic and found that the percentage of vaccinated people who developed long Covid was much lower than the percentage of unvaccinated people who did. 
    • “Medical experts have previously said that vaccines can lower the risk of long Covid, largely because they help prevent severe illness during the infection period and people with severe infections are more likely to have long-term symptoms.
    • “But many individuals with mild infections also develop long Covid, and the study, published Wednesday in The New England Journal of Medicine, found that vaccination did not eliminate all risk of developing the condition, which continues to affect millions in the United States.”
  • STAT News also informs us,
    • “A study published Wednesday in the Journal of Clinical Oncology found that certain unmatched donors, or people whose bone marrow does not as closely resemble that of the patient’s, provided similar outcomes to matched donors so long as patients receive a key drug called cyclophosphamide to prevent dangerous complications. That suggests that patients who need a transplant might be able to safely consider both matched and some unmatched donors, vastly expanding the pool of potential acceptable donors for all patients, though particularly those of African, Latino, or Asian ancestry.
    • “It’s much harder to find a match for most of my patients. Looking to people who are donor unrelated and aren’t a perfect match for my patients has become the norm,” said Sekeres, who is the chief of hematology at Sylvester Cancer Center at the University of Miami and did not work on the study. “That’s why this study really resonated with me. The classic teaching is you want a perfect match as opposed to less than perfect. What this study suggests is, if you use the right drugs after transplant, it may not be as big of a deal.”
    • “If so, up to roughly 84% of African American patients might have a potential donor in the national registry. Currently, less than 30% of African American patients have a potential match in the NMDP registry, previously called the National Marrow Donor Program.”
  • Per BioPharma Dive,
    • “A closely watched obesity pill being developed by Roche helped people in a small Phase 1 trial lose 7.3% of their body weight over four weeks when taken once daily — 6.1 percentage points more than those given a placebo, the company said Wednesday.
    • “The data comes two months after the Swiss drugmaker disclosed trial results from another obesity drug in its pipeline, which showed the once-weekly injection helped reduce body weight by 19% over six months. Roche disclosed more detailed data for that drug, indicating none of the trial participants stopped taking it due to side effects — a reason users might quit taking Wegovy or Zepbound.
    • “The two drugs came from Roche’s $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to enter a market estimated to be worth more than $100 billion annually by early next decade.”
  • Beckers Hospital Review interviews NYU Langone’s bariatric surgery chief about the first GLP-1 generic and other GLP-1 issues.
  • Per a National Institutes of Health press release,
    • “A neuroimaging study of young people who exhibit a persistent pattern of disruptive, aggressive, and antisocial behavior, known as conduct disorder, has revealed extensive changes in brain structure. The most pronounced difference was a smaller area of the brain’s outer layer, known as the cerebral cortex, which is critical for many aspects of behavior, cognition and emotion. The study, co-authored by researchers at the National Institutes of Health (NIH), is published in The Lancet Psychiatry.
    • “Conduct disorder has among the highest burden of any mental disorder in youth. However, it remains understudied and undertreated. Understanding brain differences associated with the disorder takes us one step closer to developing more effective approaches to diagnosis and treatment, with the ultimate aim of improving long-term outcomes for children and their families,” said co-author Daniel Pine, M.D., chief of the Section on Development and Affective Neuroscience in NIH’s National Institute of Mental Health. “Critical next steps are to follow children over time to determine if differences in brain structure seen in this study are a cause of conduct disorder or a long-term consequence of living with the disorder.”
  • The National Cancer Institute posted its latest cancer information highlights.
  • The Institute of Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of acoramidis (BridgeBio Pharma, Inc.), tafamidis (Vyndamax®/Vyndaqel®, Pfizer Inc.), and vutrisiran (Amvuttra®, Alnylam Pharmaceuticals, Inc.) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).”
  • AHRQ’s Patient Safety Network informs us,
    • “Patients presenting to the emergency department (ED) are triaged to prioritize care based on level of illness. In this study, 2,543 patients presenting to an ED in Switzerland were asked to self-triage using an electronic symptom-checker. (Patients were triaged and treated based on standard-of-care nurse triage.) Recommendations were given regarding time to treat (e.g., emergency) and point-of-care (e.g., self-care) and subsequently evaluated by three panels of experts. Fifty of the 2,543 patients were judged as undertriaged, but none were judged as potentially hazardous.”

From the U.S. healthcare front,

  • Healthcare Dive points out,
    • “Elevance reported solid second-quarter results on Wednesday — including $2.3 billion in profit — but the company still lowered long-term revenue growth guidance for its health insurance business. That disconnect raised red flags for analysts.”
    • “Changing revenue growth forecasts for health benefits in the middle of the year “is unusual,” commented Jefferies analyst David Windley in a Wednesday note. “We can’t identify a single, large item that would compel [the reduction] off-cycle.”
    • “During a call with investors Wednesday, Elevance management cited several factors for dropping the guidance, including significant member losses from Medicaid redeterminations and Medicare Advantage bids for 2025 that could slow growth.”
  • Fierce Pharma reports,
    • “As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations.”
    • “While J&J is “not in alignment” with IRA or its price setting process, the company has accepted the reality of the situation and baked assumptions about the future costs of its drugs into its growth projections through the end of the decade, Jennifer Taubert, EVP, worldwide chairman, innovative medicine at J&J, said on an analyst call Wednesday.
    • “As it stands, J&J currently expects to grow its business by 3% next year and then 5% to 7% out through 2030, Taubert said.”
  • Per Fierce Healthcare,
    • “Electronic health record messages to patients drafted by generative AI were of similar quality and accuracy to those written by healthcare professionals, according to a newly published study conducted using queries from NYU Langone Health patients.”
    • “The analysis, headed by researchers at the system’s affiliate NYU Grossman School of Medicine, had 16 primary care physicians rate AI and human drafts without knowing how each was written.
    • “Among a sample of 334 AI-drafted messages and 169 from professionals (both physicians and non-physicians), the raters found both sets to be on par regarding informational content, completeness and whether the grader would use the draft or start again from scratch.”
    • “The findings “suggest chatbots could reduce the workload of care providers by enabling efficient and empathetic responses to patients’ concerns,” study lead William Small, M.D., of the medical school, said in a release.”

Weekend Update

David Ermer–Congress, Medical / Rx research, Obesity, Rx coverage, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Fierce Healthcare discusses a Senate Special Committee on Aging hearing about healthcare price transparency held last Thursday July 11.
    • “If consumers or business departments received a major charge on their monthly statements with no pricing breakdown or itemized receipts, many would demand more information if not outright refuse to pay.
    • “But that’s not the case in healthcare, where unexpected fees billed from insurers and hospitals and multiplicative markups are delivered after the fact and with little explanation.
    • “That was the message senators heard loud and clear during a Thursday morning hearing of policy researchers and purchasers of commercial insurance for employees and union members.” * * *
    • [Ranking Member Sen. Mike} Braun [R Ind.] kept the legislative focus squarely on price transparency, highlighting a bipartisan package he brought with Sens. John Hickenlooper, D-Colorado; Bernie Sanders, I-Vermont; Chuck Grassley, R-Iowa; and Tina Smith, D-Minnesota, earlier this year.
    • That bill, the Health Care PRICE Transparency Act 2.0 [S. 1130], received the explicit support of multiple witnesses and other price transparency advocacy groups whose written comments were entered into the hearing’s record. It would impose data sharing standards, require negotiated rates and cash prices on machine-readable files rather than estimates, increase maximum annual noncompliance penalties and give group health plans the right to audit and review claims data.

From the public health and medical research fronts,

  • MedPage Today discusses four exceptional papers from JAMA Open Forum.
    • Item 1: Smartphone App Decreases Distracted Driving
    • Item 2: Vaping and Secondhand Nicotine Exposure in Kids
    • Item 3: New Data Adds Confidence to RSV Vaccine Safety During Pregnancy
    • Item 4: Mental Health Care Access Via Telehealth Decreased After the COVID Emergency Period.
  • The Washington Post points out
    • “A study published in the journal Alcohol: Clinical & Experimental Research looked at the reasons young adults give for not drinking, which researchers say could help in crafting public health messaging aimed at reducing alcohol abuse.
    • “Researchers focused on 614 participants who took online surveys about their alcohol use from mid-February to mid-May 2022. Participants were an average of 21.5 years old, and the majority were White (64.5 percent) and male (54.2 percent). About 65 percent were college students.
    • “Among the respondents, 49.9 percent said they were moderate drinkers, with 31.5 percent reporting binge drinking five to nine drinks in a row in the prior two weeks and 18.6 percent reporting “high-intensity drinking” of 10 or more drinks on a day in the previous two weeks, researchers at the University of Michigan’s Institute for Social Research and Texas State University report. The study was funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.”
  • The Wall Street Journal warns,
    • “With their fitness-influencer endorsements and wellness sheen, energy drinks have become more appealing to women. They’ve also become a go-to for teenage girls and young women with eating disorders.  
    • “Overconsumption of low-cal, highly caffeinated energy drinks is on the rise among young women with unhealthy eating and exercise habits, say doctors at more than a dozen of the nation’s top hospitals and eating-disorder treatment centers. Taking in too much caffeine can cause serious health problems, especially for people who aren’t eating enough, doctors say.   
    • “Brands like Celsius and Alani Nu pitch themselves as fitness aids, and, in the case of Celsius, claim to boost metabolism and burn fat. Attaining a toned body, the brands’ social-media posts suggest, looks as easy as sipping a can of the sparkling sugar-free beverages before a sweat sesh.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “The rural hospital collaborative in North Dakota has secured two value-based contracts with commercial insurers and more are expected this year, building momentum for those considering similar alliances.
    • “Cibolo Health in October created the Rough Rider High-Value Network comprised of 23 critical access hospitals in North Dakota. The rural hospital advisory firm has since helped launch a similar venture in Minnesota and is in early talks to expand the model in several other states, CEO Nathan White said.
    • “The Rough Rider network inked a Medicare shared savings contract with CVS Health and a contract with Blue Cross Blue Shield of North Dakota that includes quality-based payments and shared savings, White said. Other payers are interested in Medicare Advantage and accountable care organization contracts, he added.”
  • Healthcare Dive lets us know,
    • “Geisinger will begin a $880 million expansion of its Danville, Pennsylvania-based medical center next year, with plans to include a new 11-story medical tower, the system said Tuesday.
    • “The project will include a larger emergency department, expanded intensive care units and operating suites, as well as private rooms for each patient.
    • “The Risant Health-owned nonprofit plans to execute the expansion in phases, with a target completion date of 2028.” 
  • HR Dive informs us,
    • “With the Great Resignation far in the rearview mirror, companies now are facing another challenge: what to do when employees stay.
    • “The U.S. quit rate — often used as a measure of turnover — has remained steadily at 2.2% for the past seven months, according to the Bureau of Labor Statistics’ Job Openings and Labor Turnover Summary released July 2. 
    • “The lull in employee exits is the perfect time for employers to work on succession planning and enhancing their value proposition, according to Lauren Geer, senior vice president and chief human resources officer of IAC, a holding company to media and internet brands including Dotdash Meredith, Care.com and Angi.
    • “It’s quieter now, but I don’t think we can rest on our laurels by any means or pat ourselves on the back for what a great job we’re doing retaining our employees,” Geer said. “Now’s the time to get the house in order, because I do think there’ll be a time when the employee market picks up.” 

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Obesity, SDOH, Telehealth–

From Washington, DC,

  • Govexec informs us,
    • “The Senate on Thursday made progress on advancing bipartisan spending bills for fiscal 2025, though members of both parties acknowledged significant divisions remain between the two sides. 
    • “The chamber’s Appropriations Committee approved three of the 12 annual funding measures Congress must pass each year—those funding the departments of Agriculture and Veterans Affairs, as well as the legislative branch—in unanimous, 27-0 votes. While that marked a significant step forward in the fiscal 2025 process and an accomplishment that has eluded the panel’s House counterpart—which has advanced its bills to date only along partisan lines—the Senate could not come to a bipartisan agreement on how much money to allocate for the remaining nine funding measures.”
  • and
    • “The Senate on Wednesday voted 55-37 to confirm Anne Wagner as the third member of the Federal Labor Relations Authority, finally bringing the agency’s political leadership to nearly full strength.
    • “Similar to the National Labor Relations Board’s role overseeing collective bargaining in the private sector, the FLRA governs labor-management relations at federal agencies, with a three-member board that settles unfair labor practice complaints and other disputes between unions and management.” * * *
    • “Federal employee unions rejoiced at the news that the FLRA’s board was now fully staffed. The last 18 months of deadlock between [Colleen Duffy] Kiko and FLRA Chairwoman Susan Tsui Grundmann has meant the board could only rule in noncontroversial cases.”
  • The American Hospital Association News lets us know,
    • “The Senate Committee on Health, Education, Labor and Pensions held a hearing July 11 on medical debt. The AHA submitted a statement for the hearing that highlighted how the quality of insurance coverage is a driver of medical debt, saying that coverage for many patients is either insufficient or unavailable. The AHA discussed hospital and health system efforts offering financial and other assistance, and that hospitals absorb billions of dollars in losses for patients who cannot pay their bills, mainly due to inadequate commercial insurance coverage. To address the issue, the AHA urged Congress to restrict the sale of high-deductible health plans to individuals with the ability to afford the associated cost-sharing; prohibit the sale of health-sharing ministry products and short-term limited-duration plans that go longer than 90 days; and lower the maximum out-of-pocket cost-sharing limits, among other changes.”
    • That’s nuts, and it’s worth adding that all of the witnesses, except for one, were from the creditor side. Here’s a link to the American Enterprise Institute testimony.
  • The AHA News adds,
    • “The Centers for Medicare & Medicaid Services July 10 announced there will be 133 participants representing 772 practices for its new Making Care Primary Model. Participants in this voluntary model are from Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. The model, which began July 1 and will run through 2034, seeks to improve care management and care coordination, enable primary care clinicians to partner with health care specialists, and use community-based connections to address patients’ health needs as well as their health-related social needs such as housing and nutrition.”
  • and
    • “The Centers for Medicare & Medicaid Services recently released results of an air ambulance qualifying payment amount calculations audit on Aetna Health in Texas. The report found that Aetna used practices that did not comply with federal requirements, and strongly recommended corrective actions. Specifically, the report found that Aetna failed to “properly calculate the QPA by using claim paid amounts instead of contracted rates, and counting each claim as its own contracted rate, even when the claims were for the same amounts for the same item or service and to the same provider of air ambulance services.” Aetna may also be subjected to future audits.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Research into chronic conditions affecting women is significantly lacking, and the National Institutes of Health and other agencies should do more to investigate issues that lead to worse medical treatment for women, a new report from the National Academies of Sciences, Engineering and Medicine says.
    • “Women are disproportionately affected by chronic illnesses, including Alzheimer’s disease and depression, according to the study requested by NIH’s Office of Research on Women’s Health and published Wednesday.
    • “But inadequate research in women’s health “hinders a comprehensive understanding of the impact on women” of these and other chronic illnesses, the report’s authors write. Further research is needed, particularly for Black women, who are more likely to die of a chronic illness than White women, the study says.”
  • and
    • “Nearly 1 in 10 people infected with the coronavirus during pregnancy developed long covid, according to a study published Thursday in the journal Obstetrics and Gynecology.
    • “Thursday’s study, which highlights the consequences of the virus during pregnancy, suggests long covid is more prevalent among people infected while pregnant than in the population overall. As many as 7 percent of Americans report having symptoms associated with long covid, according to a 2022 report from the Centers for Disease Control and Prevention. Some surveys suggest a far higher incidence of long covid in the general population.” * * *
    • “I was initially surprised at the prevalence of long covid in this population,” said Torri Metz, one of the study’s lead authors and a maternal-fetal medicine specialist at University of Utah Health. “It really drew my attention to the fact I need to have this on my radar when I am seeing patients.”
  • NBC News informs us,
    • “A key mystery behind one of the most common autoimmune diseases may finally have an answer.
    • “Researchers at Northwestern Medicine and Brigham and Women’s Hospital say they’ve discovered a root cause of lupus, a disease that affects hundreds of thousands of people in the U.S. 
    • “Scientists have long suspected that a person’s genetics or hormones may predispose them to lupus, and that the disease may be triggered by environmental factors like a previous viral infection or exposure to certain chemicals.
    • “Now, a study published Wednesday in the journal Nature outlines a clear pathway for how the disease likely develops, pointing to abnormalities in the immune systems of people with lupus.”
  • Neurology Advisor points out,
    • “The prevalence of stroke has increased by 14.6% from 2011 to 2022 among individuals aged 18 to 44 and 15.7% among those aged 65 and younger in the United States, according to a report published in Morbidity and Mortality Weekly Report.
    • “Researchers assessed trends in stroke prevalence between 2011 and 2022, using data from the Behavioral Risk Factor Surveillance System (BRFSS), a state-based surveillance system administered to noninstitutionalized civilian adults in the US in collaboration with the Centers for Disease Control and Prevention (CDC). * * *
    • “Age-standardized prevalence of stroke increased from 2.7% in 2011 to 2013 to 2.9% in 2020 to 2022, marking a 7.8% (95% CI, 4.9%-10.8%) increase in overall stroke prevalence. The researchers noted the highest stroke prevalence (7.7%; 95% CI, 7.5%-7.9%) among individuals aged 65 and older and the lowest prevalence (0.9%; 95% CI, 0.8%-1.0%) among individuals aged between 18 and 44 years.
    • “Stroke was observed to be highest (5.3%; 95% CI, 4.7%-5.9%) among the American Indian or Alaska Native group and lowest among the Asian group (1.6%; 95% CI, 1.2%-2.0%).
    • “With regard to educational level, individuals with a high-school diploma had the highest stroke prevalence (5.2%; 95% CI, 4.8%-5.4%) and those with a college degree or higher had the lowest stroke prevalence (1.7; 95% CI, 1.6%-1.8%).”
  • STAT News relates,
    • “Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, viruses, excess body weight, alcohol drinking and more. Data was from 2019 in order to avoid the influence of the pandemic, when cancer diagnoses declined because of delayed care. The results were published in the American Cancer Society’s journal, CA: A Cancer Journal for Clinicians.” * * *
    • “In the study, alcohol was associated with seven cancers: oral cavity, pharynx, larynx, colorectum, and female breast, as well as squamous cell carcinoma in the esophagus, and hepatocellular carcinoma in the liver. Beyond those, “there is accumulating evidence” that alcohol can cause other cancers, such as pancreatic cancer, said lead author Farhad Islami, senior scientific director of cancer disparity research at ACS (which funded the study). 
    • “The increased risk is because of the alcohol in alcoholic beverages, not the type of beverage,” he said. A standard alcoholic beverage in the United States has about 14 grams of pure ethanol. That looks like one 12-ounce serving of 5% ABV beer, a 5-ounce serving of 12% ABV wine, 8-10 ounces of 7% ABV hard seltzer, or 1.5 ounces of 40% ABV liquor. Research suggests the higher a person’s consumption, the higher the risk of cancer.”
  • Here is a link to the NIH Director’s blog titled this week “Sequencing Technique Detects Earliest Signs of Genetic Mutations Underlying Cancer, Aging, and More”
  • The National Institutes of Health announced,
    • “Early findings from a small clinical trial provide evidence that a new cellular immunotherapy approach may be effective in treating metastatic solid tumors. In the trial, researchers from the National Institutes of Health (NIH) genetically engineered normal white blood cells, known as lymphocytes, from each patient to produce receptors that recognize and attack their specific cancer cells. These initial findings are from people with metastatic colorectal cancer who had already undergone multiple earlier treatments. The personalized immunotherapy shrank tumors in some patients and was able to keep the tumors from regrowing for up to seven months. The findings were published July 11, 2024, in Nature Medicine.” * * *
    • “Colon cancer is just one of many solid tumors the researchers are studying. The trial is still ongoing and includes patients with different types of solid cancers.
    • “It’s just the very beginning of converting normal lymphocytes into cells capable of treating the common solid cancers,” Dr. Steven A. Rosenberg, a co-leader of the study, said. “What this study shows is that it’s possible. Once you know it’s possible, you work to improve it.”
  • Here is a link to the All of Us Program’s latest Medical Minutes.

From the U.S. healthcare business front,

  • Beckers Hospital Review tells us,
    • “As more older adults opt for Medicare Advantage plans, reimbursement fights between hospitals and insurers are increasingly centered around those contracts.
    • “According to data shared with Becker’s by FTI Consulting, there were 20 reimbursement disputes between hospitals and insurers that made headlines somewhere in the country during the second quarter, the same amount as the first quarter and slightly lower than the same period in 2023, when 24 contract disputes were reported in national or local media.
    • “Notably, a record number of Q2 disputes (15 of 20) involved Medicare Advantage plans, and 30% of disputes failed to reach a timely agreement, meaning tens of thousands of patients were left without in-network coverage. FTI has tracked media reports regarding negotiations over reimbursement rates during each quarter since early 2022.”
  • BioPharma Dive reports,
    • “On Thursday, the pharmaceutical giant [Pfizer] said it is advancing a once-daily version of an experimental and closely watched medicine called danuglipron. Pfizer based the decision on results from a small clinical trial of healthy volunteers that’s been evaluating how the body interacts with danuglipron. Studies designed to find the optimal dose of the medicine are scheduled for later this year.
    • “Umer Raffat, an analyst at the investment firm Evercore ISI, speculates that with its update Thursday, Pfizer is “likely buying time” to see more data from a backup once-daily drug it’s been developing. “Candidly, the trial that just wrapped up never answered the question on” what dose would be effective enough to compete, he wrote in a note to clients.
    • “In that backdrop, the judicious thing to do from [the] Pfizer perspective was to not overcommit — and that’s exactly what they did today,” Raffat added. They “didn’t kill [danuglipron], they said it may move forward, but not right to [Phase 3].”
  • Beckers Payer Issues adds,
    • “As insurers continue to face major financial pressures related to covering weight loss drugs, many are steering more patients toward bariatric surgery to achieve similar results.
    • “Insurance companies are seeing that they’re getting more reliable outcomes and savings in the long run if they pay for someone to have bariatric surgery,” Christine Ren Fielding, MD, told Becker’s. Dr. Ren Fielding is a professor of surgery at NYU School of Medicine, the director of the NYU Langone Weight Management Program and chief of the system’s division of bariatric surgery.
    • “If you’re a responder to appetite control caused by a GLP-1, then there’s another treatment option that will do exactly the same thing: bariatric surgery. That includes Lap-Band, sleeve gastrectomy, and gastric bypass,” she said. “Bariatric surgery is the old-fashioned way. Insurers are now putting up barriers for people who want to be covered for GLP-1s and taking down barriers for people who want to have surgery.”
  • STAT News informs us,
    • “The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant.
    • “The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.”

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.”