Thursday Miscellany

Mental health care

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.”

Tuesday Tidbits

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, NIH, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fierce Healthcare reports,
    • “The Centers for Medicare & Medicaid Services (CMS) is creating a voluntary demonstration program to support changes to Medicare Part D under the Inflation Reduction Act (IRA).
    • “The agency also finalized bid information for contract year 2025, with a base beneficiary premium increase of $2.08 for people with Part D.
    • “The IRA is designed to limit yearly premium increases from contract year 2024 to 2029. Because Part D and prescription drug plans can result in plan price variation for beneficiaries, CMS is creating the Part D Premium Stabilization Demonstration to “improve premium stability for participating stand-alone prescription drug plans,” according to a news release.
    • “This should result in a smoother rollout in how the IRA requires Medicare to support Part D prescription plans. The program will test whether even more financial requirements would improve the Part D program, a senior CMS official said Monday afternoon.”
  • Here is the link to the CMS fact sheet for the Part D demonstration project and bid information.
  • American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services July 30 issued a final rule updating hospice payment rates for fiscal year 2025. Overall, CMS finalized a 2.9% net increase to payments compared with FY 2024. This includes a 3.4% market basket update and a 0.5 percentage point cut for productivity. As a result of this increase, the hospice payment cap will be increased from $33,494.01 to $34,465.34. CMS also finalized adoption of the most recent Office of Management and Budget statistical area delineations, which will affect the wage index used by some providers. In addition, the rule adopts a new patient-level data collection tool to replace the existing Hospice Item Set and also adds two new process measures beginning in FY 2028.”
  • Here is a link to the CMS fact sheet on the hospice payment rates.
  • The Washington Post informs us,
    • “The Centers for Disease Control and Prevention is launching a $5 million initiative to provide seasonal flu shots this fall to about 200,000 livestock workers in states hardest hit by the bird flu outbreak.
    • “Workers on poultry, dairy and pig farms are at greatest risk of being simultaneously exposed to seasonal flu and the H5N1 bird flu that has infected at least 172 dairy herds in 13 states, according to the Department of Agriculture. Such exposures raise the rare risk of the two viruses exchanging genetic material, a process known as reassortment, to create a new influenza virus that “could pose a significant public health concern by becoming more efficient at spread and potentially more severe,” Nirav Shah, CDC’s principal deputy director, said at a news briefing Tuesday. Widespread seasonal flu vaccination would reduce that risk, he said.
    • “Thirteen farmworkers have been infected in the outbreak. All had mild symptoms and recovered.
  • Per an HHS press release,
    • Today, the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of the 2023 National Survey on Drug Use and Health (NSDUH), which shows how people living in United States reported their experience with mental health conditions, substance use and pursuit of treatment. The 2023 NSDUH report includes selected estimates by race, ethnicity and age group. The report is accompanied by two infographics offering visually packaged highlight data as well as visual data by race and ethnicity.
  • The press release includes key findings from the survey.
  • MedTech Dive tells us about how a “[p]atient shares a day in the life with diabetes at FDA’s first Home Health Hub meeting. The initiative, led by new CDRH Acting Director Michelle Tarver, is intended to improve health equity by including people’s living conditions in device design.”
  • The Assistant Secretary of Labor for Employee Benefit Security seeks in her blog to “raise awareness and break the silence surrounding minority mental health.
  • HHS’s Office for Civil Rights amended its Change Healthcare Cybersecurity Incident FAQ three to read as follows:
    • “3. Have Change Healthcare or UHG filed a breach report with HHS?
    • “A: Yes, on July 19, 2024, Change Healthcare filed a breach report with OCR concerning a ransomware attack that resulted in a breach of protected health information. Change Healthcare’s breach report to OCR identifies 500 individuals as the “approximate number of individuals affected”. This is the minimum number of individuals affected that results in a posting of a breach on the HHS Breach Portal. Change Healthcare is still determining the number of individuals affected. The posting on the HHS Breach Portal will be amended if Change Healthcare updates the total number of individuals affected by this breach. HIPAA breach reports filed on the HHS Breach Portal may be amended as the breach report form allows a filer to file an initial breach report or an addendum to a previous report.”
  • Per a press release from the U.S. Attorney for the District of Massachusetts,
    • “Burlington County Eye Physicians (BCEP), an ophthalmology practice with locations in New Jersey and Pennsylvania, and Dr. Gregory H. Scimeca, an ophthalmologist and the owner of BCEP, have agreed to pay $469,232 to resolve allegations that they submitted and caused the submission of false claims for payment for medically unnecessary transcranial doppler (TCD) tests to Medicare and the Federal Employee Health Benefit (FEHB) Program in violation of the False Claims Act. 
    • “A TCD test is a noninvasive diagnostic test that can be used to estimate the blood flow through certain blood vessels in the brain. Medicare and the FEHB Program reimburse healthcare providers for both performing the test and for interpreting the test results. When a physician does not perform the test, but interprets the results of the test, they only can bill for their professional services of interpreting the test. A physician cannot bill for interpreting the test when they merely review another physician’s interpretation of the results.”  

From the public health and medical research front,

  • The Washington Post reports,
    • “The suicide rate for U.S. children 8 to 12 years old has steadily climbed in the past decade and a half, with a disproportionate rise among girls, data released Tuesday by the National Institute of Mental Health shows.
    • “The findings, published in the journal JAMA Network Open, highlight pervasive issues regarding mental health that affect U.S. children daily, the study authors said.
    • “The authors of the study blame no single reason for the increase, but experts not involved in the study say the problem is multifaceted, citing technology, social media and guns as the main culprits.
    • “Between 2001 and 2022, 2,241 children ages 8 to 12 — known as preteens — died by suicide. While suicide rates were decreasing until 2007, they increased by about 8 percent each year from 2008 to 2022.
    • “From 2001 through 2007, 482 children ages 8 to 12 died by suicide at a rate of 3.34 per 1 million “preteens. From 2008 to 2022, the number of suicides in that age group rose to 1,759, with a rate of 5.71 per 1 million.”
  • Per STAT News,
    • “If millions of Americans no longer qualify for a statin or a blood pressure medication based on a new calculator updated to better predict their risk, that could lead to 107,000 more heart attacks and strokes over 10 years, a new study estimates.
    • “The research paper, published Monday in JAMA, is the second in two months drawing attention to widely used medicines designed to prevent the leading cause of death in the United States.
    • “The research is creating a buzz in cardiology circles while two medical societies formulate new guidelines to inform practice, weighing the new risk models and existing thresholds that trigger prescriptions.
    • “This is concerning that we could reverse eligibility for many millions of Americans,” Raj Manrai, assistant professor of biomedical informatics in the Blavatnik Institute at Harvard Medical School and senior author of the new study, said in an interview. “We really need to reexamine the other side of the equation here, which is how those risk estimates are going to be used by patients and physicians to decide who and when individuals receive preventative care, particularly statins and antihypertensive blood pressure medications.”
  • Per a National Institutes of Health (NIH) press release,
    • “A new global study sponsored by the National Institute of Allergy and Infectious Diseases has determined that cabotegravir, an antiretroviral medication used for HIV treatment, is safe for use before and during pregnancy. The study analyzed the pregnancy and infant outcomes of using long-acting injectable cabotegravir in more than 300 pregnant women. These findings fill an important knowledge gap that will help increase access to HIV treatment for cisgender women before, during, and after pregnancy.” 
  • NIH also posted a summary of recent medical research developments.
  • STAT News relates,
    • “A new study suggests that an older GLP-1 drug may help protect the brains of people with early Alzheimer’s disease, supporting the case for further research on the class of medications — originally developed for obesity and diabetes — in neurological diseases.
    • “The Phase 2 randomized trial, led by researchers at Imperial College London, tested Novo Nordisk’s liraglutide, the predecessor to Ozempic and Wegovy, in patients with early Alzheimer’s disease over one year. The study did not meet the primary endpoint of change on a measure of how much sugar the brain uses for energy, but it showed that patients on the drug had nearly 50% less shrinking in parts of the brain that control memory and learning and that treated participants had a slightly slower decline in cognitive function.”
  • CNN adds,
    • “A growing set of evidence suggests that using semaglutide could lead to decreased substance use, and a large new study shows a promising link between the medication and tobacco use. But experts emphasize that much more research is needed before using the medications off-label for smoking cessation.
    • “In a study published Monday in the journal Annals of Internal Medicine, researchers tracked the medical records of more than 200,000 people who started medications to treat type 2 diabetes, including nearly 6,000 people using semaglutide medications such as Ozempic.
    • “Over the course of a year, people who started using semaglutide were significantly less likely to have medical encounters for tobacco use disorders, prescriptions for medications for smoking cessation or counseling for smoking cessation than those who started other diabetes medications such as insulin and metformin.
    • “The study authors note that the reasons individuals might be less likely to seek medical treatment for tobacco use disorder vary widely; it could suggest that their tobacco use decreased or that they’ve become less willing to seek help to quit smoking, for example.”

From the U.S. healthcare business front,

  • Reuters points out,
    • “Four pharmaceutical companies involved in the first U.S. negotiations over prices for the Medicare program said they do not expect a significant impact on their businesses after seeing confidential suggested prices from the government for their drugs that will take effect in 2026.
    • “Top executives from Bristol Myers Squibb (BMY.N), opens new tab, Johnson & Johnson (JNJ.N), AbbVie (ABBV.N), and AstraZeneca (AZN.L), which have five of the 10 drugs chosen for the first wave of negotiations, described their newly informed views on quarterly conference calls.”
  • Modern Healthcare notes,
    • “Drug prices are expected to increase 3.81% next year, propelled by expensive cell and gene therapies and glucagon-like peptide agonists.
    • “The estimate from Vizient, a group purchasing organization, tops the company’s 2024 drug cost growth projection of 3.42%. Vizient uses recent provider purchasing data to forecast what hospitals and health systems might pay for drugs after discounts and rebates.”
  • The Wall Street Journal reports,
    • “Pfizer’s quarterly results beat Wall Street estimates and the drugmaker raised its outlook, denoting strong demand for its non-Covid products. * * *
    • “Pfizer’s revenue was boosted by several acquired products and recent commercial launches, which offset a decline from its Covid-19 vaccine Comirnaty, and unfavorable foreign currency translation. Excluding Covid products, revenue rose 14% on the year.
    • “Chief Financial Officer David Denton said this was the first quarter of top-line growth since the end of 2022, when Pfizer’s Covid-related revenues peaked.
    • “Pfizer Chief Executive Albert Bourla said in an interview the company is making progress on its strategy to drive growth and improve the company’s share price through dealmaking, including its $43 billion acquisition of cancer-maker; cost-cutting programs; and launching new medicines.
    • “We are progressing on all cylinders,” he said.”
  • Per STAT News,
    • “Shares of Merck fell 9% Tuesday after the company reported that in the second quarter, it saw a decrease in shipments of its HPV vaccine Gardasil in China, a significant market for the drug.
    • “The company brought in $2.48 billion in sales of Gardasil in the second quarter, slightly lower than estimates of $2.5 billion made by analysts polled by Visible Alpha.
    • “Despite the Gardasil hit, Merck raised guidance for full-year sales to $63.4 to $64.4 billion from the previously guided $63.1 to $64.3 billion. The company lowered guidance for full-year earnings, though, to $7.94 to $8.04 per share from the previously forecasted $8.53 to $8.65, due to expenses related to the acquisition of ophthalmology-focused biotech EyeBio.”
  • Per Healthcare Dive,
    • “Google will not renew its contract with Amazon’s primary care subsidiary One Medical, ending a longstanding agreement that gave Google employees access to discounted medical care, the companies confirmed to Healthcare Dive.
    • “The contract loss is a major blow for the provider. Google was One Medical’s largest customer, accounting for 10% of its revenue in 2020. That figure dipped slightly in 2021, after which One Medical stopped disclosing its finances publicly.
    • “The decision is not because One Medical was acquired by Google rival Amazon last year, a Google spokesperson said. The current contract will expire at the end of 2024.”
  • and
    • “Mental telehealth coverage has contracted slightly since the government declared an end to the COVID-19 public health emergency last year, according to a new study published in JAMA.
    • “The study, which analyzed over 1,000 outpatient mental health treatment facilities, found that publicly owned mental health treatment facilities were less likely to have adopted telehealth services at all, and more likely to have discontinued them after the Biden administration ended the COVID PHE, compared to privately owned facilities.
    • “The results come as lawmakers are considering whether to permanently expand telehealth flexibilities to providers this year, after the federal government enacted temporary policies that expanded access to telehealth services during the pandemic.”
  • The Washington Post gives us a heads up on the test run of drones to deliver cardiac care to patients in North Carolina.
    • “What if the first responder on the scene of a cardiac arrest were a drone carrying an automated external defibrillator?
    • “When every second counts, public safety professionals are increasingly eyeing drones — which can fly 60 miles an hour and don’t get stuck in traffic — to deliver help faster than an ambulance or EMT.
    • “Starting in September, 911 callers in Clemmons, N.C., may see a drone winging its way to those suffering a cardiac arrest. Under a pilot program operated jointly by the Forsyth County Sheriff’s Office, local emergency services, the Clinical Research Institute at Duke University and drone consulting firm Hovecon, drone pilots from the sheriff’s department will monitor 911 calls and dispatch drones.”
  • The Wall Street Journal lets us know,
    • “Theranos’s ambitions for a finger-prick blood test are finally being realized—by other companies.
    • “”Since May, needle-phobic people in Austin, Texas, have been able to visit pharmacies for routine medical tests on drops of blood squeezed from their fingertips, rather than the usual way of plunging a needle into a vein in the arm and drawing large vials of blood. 
    • The rise and fall of Theranos—the Silicon Valley startup that promised to revolutionize blood testing but ended dissolved, with its founder Elizabeth Holmes convicted of fraud—cast a pall over the idea that critical medical tests could be run on mere drops of blood.
    • “Demand for alternatives to standard blood draws never went away, however. And companies—including Becton Dickinson and Babson Diagnostics, which make the tests rolling out in Austin—have been working out technological kinks that foiled Theranos.”
    • FEHBlog observation: As the old saying goes, timing is everything.


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.


Weekend Update

David Ermer–Congress, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC,

  • While the House of Representatives has begun its August recess, the Senate will continue Committee business and floor voting this week.
  • Roll Call notes,
    • “The Department of Veterans Affairs is facing a nearly $15 billion combined budget shortfall this fiscal year and next, and congressional Republicans are crying foul at the last-minute notification about a funding crisis lawmakers have little time to try to fix.
    • “VA officials told lawmakers on July 15 that the agency needs $2.9 billion in mandatory spending for veterans’ pensions and other benefits to cover a gap for the remaining months of the fiscal year ending Sept. 30. And they need another $12 billion in discretionary medical care funds for next year on top of what was provided in a March appropriations package or in the fiscal 2025 House and Senate Military Construction-VA bills.
    • “The notification came after the House passed its fiscal 2025 Military Construction-VA bill on June 5, and after the Senate Appropriations Committee marked up its version on July 11.” * * *
    • “According to agency officials, the crux of the issue is increased demand for health care services amid implementation of a 2022 law that expanded access for veterans exposed to burn pits and other toxins while serving in combat zones. Previously, veterans who got sick needed to prove their illnesses were directly tied to their military service; now, the presumption is such diseases are service-connected. [FEHBlog note — The cost of VA treatment for service-connected medical issues cannot be passed along to the FEHBP or other health plans.}
    • “Over the last 365 days, 412,867 veterans have enrolled in VA care — a 27 percent increase compared to the previous year, VA press secretary Terrence Hayes said Thursday.” * * *
    • “It’s not clear how lawmakers will move to address the shortfall.”

From the public health and medical research front,

  • The New York Times reports
    • “Scientists have made another major stride toward the long-sought goal of diagnosing Alzheimer’s disease with a simple blood test. On Sunday [July 28], a team of researchers reported that a blood test was significantly more accurate than doctors’ interpretation of cognitive tests and CT scans in signaling the condition.
    • “The study, published Sunday in the journal JAMA, found that about 90 percent of the time the blood test correctly identified whether patients with memory problems had Alzheimer’s. Dementia specialists using standard methods that did not include expensive PET scans or invasive spinal taps were accurate 73 percent of the time, while primary care doctors using those methods got it right only 61 percent of the time.” * * *
    • “The results, presented Sunday at the Alzheimer’s Association International Conference in Philadelphia, are the latest milestone in the search for affordable and accessible ways to diagnose Alzheimer’s, a disease that afflicts nearly seven million Americans and over 32 million people worldwide. Medical experts say the findings bring the field closer to a day when people might receive routine blood tests for cognitive impairment as part of primary care checkups, similar to the way they receive cholesterol tests.”
  • An author writes an opinion column in the Washington Post about visiting happy to chat park benches in London, England where she opened up with strangers thereby boosting her Vitamin S.
    • “There’s some science to this. Paul van Lange, a Dutch psychologist, labels the phenomenon “Vitamin S.” His research shows that strangers often confide in each other: “Most of our relationships include a power dynamic even if we’re unaware of it. But two strangers on a bench are equal and equally vulnerable,” he told me. And strangers don’t carry the risk of spilling our secrets to the rest of our social network. Van Lange’s studies also show that these interactions can promote mental well-being, explaining why my bench chats were such a mood booster.
    • “But Vitamin S has other benefits, too. Talking to strangers is like an exercise — we need to practice it regularly or risk losing the muscle for it. This “mental fitness” is bolstered when our brains use infrequently activated neural networks to converse with strangers.”
  • The idea has crossed the pond to the U.S.
  • The Post also discusses the summertime risks of having a pedicure.
    • “David Murgueytio had his first pedicure about two years ago in a Rockville, Md., nail salon. It also was his last.
    • “The pedicurist pushed his cuticles back with a sharp little scooped tool — “he dug in deep — and it hurt,” he says. The next morning, the big toe on his right foot was red and swollen. Two weeks later, when he finally went to a doctor, the toe had turned an alarming shade of dark green — “nearly black,” he says, “and I could hardly walk.”
    • “Murgueytio, 40, a personal trainer from Clarksburg, Md., recovered after a 14-day course of antibiotics and a warning from his doctor about taking too long to be seen, risking an infection that could spread to the rest of his body. He learned his lesson. “I’m doing my own toes now,” he says.” * * *
    • “With summer underway, it’s often tempting to go barefoot, especially at the pool or beach. This can be risky after a pedicure if the cuticles have been recently cut or trimmed, experts say.
    • “I wouldn’t walk through the sand barefoot,” says Adam Friedman, professor and chair of dermatology at the George Washington University School of Medicine and Health Sciences. “Little particles of sand can get in, causing irritation and inflammation, and introducing bacteria and other microorganisms.” (This is true for any open cuts or wounds, not just from pedicures.)”
  • Fortune Well also discusses how much water adults should drink daily.
    • “Water is essential for your body’s survival,” says Crystal Scott, registered dietitian-nutritionist with Top Nutrition Coaching. “It helps regulate your temperature, transports nutrients, removes waste, lubricates your joints and tissues, and it also plays a crucial role in maintaining the delicate balance of electrolytes and fluids in your body.” * * *
    • “The National Academy of Science, Engineering and Medicine recommends an average daily water intake of about 125 ounces for men and about 91 ounces for women. If you’re not filling up a water bottle to exactly that amount every day, you’re probably still close or even over, because you also get water from food, says Scott.
    • “You can get a lot of hydration from foods like celery, oranges, strawberries, watermelon, and cucumbers,” she says. “All are hydrating foods that can actually help supplement your water intake.” * * *
    • “For the majority of the population, the bigger issue is getting enough water. While it’s helpful to keep tabs on actual ounces, the best indicator of whether you’re well hydrated is your body. When you don’t get enough water, your body will show certain signs.
    • “Urine color is a really great indicator of hydration status,” says Scott. If your toilet water is pale yellow or clear after you pee, you’re golden. Dark yellow or amber colored urine are signs your body needs fluids.”
    • “When in doubt, go to the spout.”

From the U.S. healthcare business front,

  • In MedPage Today, an emergency room physician explains the phenomenon of “induced demand” as applied to emergency facilities.
    • Induced demand is economist-speak for the concept that building more of something in high demand can actually increase demand for that thing.  * * *
    • Today, U.S. emergency departments (EDs) face a conundrum [similar to highway traffic congestion] — seemingly limitless demand for emergency services. Beginning in 2012, the annual number of ED visits nationally jumped from 131 to 150 million in just 7 years, easily outstripping population growth. A recent study in California found that from 2011 through 2019, ED visits increased 23.4% while the state’s population grew by only 5%. * * *
    • “During my 20 years as a frontline emergency medicine physician, my healthcare organization has added both a hospital and an urgent care to my service area, created additional shifts at each of our facilities, and ramped up the speed at which physicians treat patients. After a decade of well-intended capacity expansion, our ED volumes remain at an all-time high. In the context of a national healthcare worker shortage, staffing often becomes the rate-limiting step that ultimately kills further expansion attempts. As the authors of the UC Davis study gamely note, “ED expansion alone does not appear to be an adequate solution to ED crowding.” * * *
    • “[O]ne effective approach to decreasing traffic relies on the concept that one of the most effective deterrents to congestion is congestion itself. Posting highway travel times sets realistic expectations and helps drivers make wiser decisions about whether it’s worth it to continue their trip. * * * This may be what the Academic College of Emergency Physicians (ACEP) was thinking when it proposed posting wait times and triaging low acuity patients to a non-ED setting.” * * *
    • “A proliferation of alternate care options such as urgent care and telemedicine appointments now make this concept of redistributed flow all the more realistic.”
  • MedTech Dive interviewed “Stacey Churchwell, general manager of Medtronic’s cardiovascular diagnostics and services business, to discuss the company’s integration of AI algorithms for detecting abnormal heart rhythms into its insertable cardiac monitors (ICMs). The miniature devices — the latest version is about a third the size of a triple A battery — are implanted under the skin in a patient’s chest to help diagnose abnormal heart rhythms such as atrial fibrillation (AFib).” Check it out.

Tuesday Tidbits

David Ermer–Congress, Electronic health records, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Modern Healthcare reports,
    • “Lawmakers and executives from three major pharmacy benefit managers presented diametrically opposing views at a heated Capitol Hill hearing Tuesday, as major bills aimed at reining in the organizations remain stalled in Congress. 
    • “Members of the House Committee on Oversight and Accountability blamed the highly concentrated PBM industry for raising drug prices and running independent pharmacies out of business, while leaders from CVS Caremark, Express Scripts and Optum Rx all countered that the sector in fact lowers prices and supports local pharmacies.
    • “The hearing accompanied the committee’s release of a report detailing what its investigators characterized as abuses by the three large companies.”
  • Govexec lets us know,
    • “A federal employee group within the Justice Department last week made its final pitch to the federal government’s dedicated HR agency to boost the federal government’s coverage of in vitro fertilization and other assisted reproductive technology through the Federal Employees Health Benefits Program.
    • “The Department of Justice Gender Equality Network, an employee association representing nearly 2,000 workers at the Justice Department, sent acting Office of Personnel Management Director Rob Shriver three dozen testimonials from members describing the hardships they endured while trying to conceive. The move comes amid OPM’s final round of negotiations with insurance carriers over what FEHBP plans will cover next year.”
  • Federal News Network tells us,
    • “More than 15 years in the making, plans to update the federal pay system for blue-collar government employees are finally gaining some traction.
    • “A proposal to reform the Federal Wage System (FWS) has moved into the early stages of the government’s rulemaking process, the Federal Prevailing Rate Advisory Committee (FPRAC) announced during a public meeting Thursday morning.
    • “The proposal, if finalized, would amend the federal pay system for blue-collar government workers, more closely aligning it with the locality pay areas for the General Schedule (GS). An estimated 15,000 blue-collar feds would see their pay rates increase.”
  • Fierce Healthcare informs us,
    • “Walgreens has received $25 million in grant funding to conduct a decentralized clinical trial assessing how well a person vaccinated against COVID-19 is protected from future infections. 
    • “The award funding comes from a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), embedded in the U.S. Department of Health and Human Services. The partnership is BARDA’s first with a major retail pharmacy. Walgreens will conduct a phase IV observational clinical study, using COVID vaccine data, to assess correlates of protection, known as responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data.
    • “The initiative’s goal is to increase access to clinical trials. Currently, participants in a vaccine clinical trial often travel to hospitals, universities or other central locations that are far from their homes. Taking a decentralized approach through a geographically diverse retailer like Walgreens can help reach patients where they are and enable the collection of real-world data, the organizations said. The partners also hope that learning what aspects of decentralized clinical trials work for vaccine correlates of protection studies can help drive future studies at scale.”
  • The Office of National Coordinator for Health Information Technology issued a standards bulletin that is “a companion to the USCDI v5 standard document published in July 2024. This issue provides background of USCDI v5 and the new data classes and elements that support improved patient care and advance the Administration’s goals of equity, diversity, and access to health care.”
  • The Food and Drug Administration announced,
    • On Monday, [July 22,] the FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
    • “Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”
    • The most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. See full prescribing information for additional information on the safety and effectiveness of Femlyv.

From the public health and medical research front,

  • The American Hospital Association News relates,
    • “The Department of Health and Human Services July 23 released an amendment to a 2013 emergency declaration under the Food, Drug and Cosmetic Act that broadens the scope in which the agency can help facilitate certain medical countermeasures in response to a public health emergency such as a pandemic. The amendment now applies to pandemic influenza A viruses and others with pandemic potential, such as the current H5N1 strain of bird flu that has infected cattle and subsequently humans in some states. Previously, the declaration specifically covered just the H7N9 strain of bird flu. The declaration would allow the Food and Drug Administration to extend the expiration date of certain medical products and allow HHS to issue an emergency use authorization for unapproved drugs, devices or products, among other actions.”
  • Per BioPharma Dive,
    • “An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded in a late-stage trial, the company said Tuesday.
    • “In a statement, Merck said the therapy, an antibody called clesrovimab, met its main safety and efficacy objectives in a placebo-controlled trial involving more than 3,600 healthy or preterm infants. Those goals included the incidence of RSV-associated lower respiratory infections requiring medical attention over the course of five months, compared to placebo, as well as the percentage of patients experiencing certain types of adverse events.
    • “A spokesperson told BioPharma Dive in an email that clesrovimab met a key secondary measure by reducing the risk of hospitalization from RSV in the trial. But the company didn’t provide specifics on that result or the rest of the study findings, which will be presented at a future medical meeting. In the meantime, Merck plans to share the data with global health authorities.”
  • Per National Institutes of Health press releases,
    • “Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
    • “Cisgender women experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during pregnancy and the postnatal period, and we need to offer them evidence-based options when they may need them most,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy.”
  • and
    • “A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive. The findings were presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
    • “We are still learning how to optimize the package of services that accompany long-acting PrEP, including HIV testing,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “The viral load testing findings observed in this study illuminate performance gaps in the current U.S. HIV testing algorithm for injectable cabotegravir PrEP.”
  • and
    • “Researchers at the National Institutes of Health (NIH) found that an artificial intelligence (AI) model solved medical quiz questions—designed to test health professionals’ ability to diagnose patients based on clinical images and a brief text summary—with high accuracy. However, physician-graders found the AI model made mistakes when describing images and explaining how its decision-making led to the correct answer. The findings, which shed light on AI’s potential in the clinical setting, were published in npj Digital Medicine.  The study was led by researchers from NIH’s National Library of Medicine (NLM) and Weill Cornell Medicine, New York City.
    • “Integration of AI into health care holds great promise as a tool to help medical professionals diagnose patients faster, allowing them to start treatment sooner,” said NLM Acting Director, Stephen Sherry, Ph.D. “However, as this study shows, AI is not advanced enough yet to replace human experience, which is crucial for accurate diagnosis.”
  • Per MedPage Today,
    • “Patients with dementia may instead have hepatic encephalopathy (HE) and should be screened with the Fibrosis-4 (FIB-4) index for cirrhosis, one of the main causes of the condition, new research suggests.
    • “The study of more than 68,000 individuals in the general population diagnosed with dementia between 2009 and 2019 found that almost 13% had FIB-4 scores indicative of cirrhosis and potential HE.
    • “The findings, recently published online in The American Journal of Medicine, corroborate and extend the researchers’ previous work, which showed that about 10% of US veterans with a dementia diagnosis may in fact have HE.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “HCA Healthcare reported second-quarter earnings that handily beat Wall Street expectations.
    • “The Nashville, Tennessee-based operator posted $17.5 billion in revenue, a net income of $1.5 billion and a 5.8% increase in same facility admissions. During a call Tuesday, HCA’s executive team attributed the company’s success to broad demand for services and an ability to manage expenses.
    • “HCA updated its full-year revenue guidance following the results. It now expects to draw between $69.8 billion and $71.8 billion, up from the originally forecast $67.8 billion to $70.3 billion.”
  • Modern Health points out,
    • “Molina Healthcare said Tuesday it is expanding into Connecticut through an agreement to acquire EmblemHealth subsidiary ConnectiCare Holding Co., for $350 million.
    • “The Farmington, Connecticut-based health insurer has approximately 140,000 members in marketplace, Medicare and other health insurance plans across the state, according to a news release. Molina said the purchase price represents a quarter of ConnectiCare’s $1.4 billion in expected 2024 revenue. The company said it will fund the deal with cash on hand and plans to close it in the first half of 2025.
    • “The ConnectiCare purchase is part of Long Beach, California-based Molina’s strategy to develop stable revenue streams and deploy capital more efficiently, President and CEO Joe Zubretsky said in the news release.
    • “The deal is Molina’s second acquisition this year. In January it completed the purchase of Bright Health Group’s California Medicare Advantage business for $425 million.”
  • Beckers Hospital Review identifies fifteen health systems that are dropping certain Medicare Advantage plans and notes,
    • Medicare Advantage accounted for around 1 in 4 inpatient hospitals days in 2022, according to a report from KFF published July 23.  * * *
    • In rural and micropolitan counties, the share of inpatient days from Medicare Advantage enrollees doubled between 2015 and 2022. 
    • Read more here. 
  • Behavioral Health Business discusses virtual applied behavioral therapy.
    • “It’s no secret that there is a steep supply-and-demand issue for applied behavior analysis (ABA) services nationwide. 
    • “The industry is relatively new, which means the pool of qualified professionals is still small compared to the need. There are less than70,000 board-certified behavior analysts in the U.S. Still, autism impacts 1 in 36 children, according to the CDC. 
    • “Many of those qualified clinicians are prioritizing flexibility in the workplace and turning to telehealth.”

Monday Roundup

David Ermer–ACA, CDC, CMS, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Healthcare Dive reports,
    • “The Biden administration is making it harder for insurance agents and brokers to change people’s plans on the federal Affordable Care Act marketplace following mounting consumer complaints about unauthorized changes.
    • “On Friday, the CMS announced agents can’t make changes to a consumer’s enrollment in the federal exchanges unless they’re already associated with that consumer. If agents and brokers are unassociated, they have to take additional steps to update a consumer’s marketplace enrollment — even with that consumer’s consent, according to the notice.
    • “Unassociated brokers will have to have a three-way call with the beneficiary and the marketplace’s call center, or have the beneficiary change their enrollment themselves through HealthCare.gov or another approved portal. The changes, which don’t apply to the 18 states (and Washington, D.C.) that run their own insurance marketplaces, took effect immediately.”
  • Per an HHS press release,
    • “The Biden-Harris Administration’s Kids Online Health and Safety Task Force, co-led by the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Commerce’s (DOC) National Telecommunications and Information Administration (NTIA), released a new report today with recommendations and best practices for safer social media and online platform use for youth. The recommendations in the report, Online Health and Safety for Children and Youth: Best Practices for Families and Guidance for Industry, underscore the Administration’s efforts to address the ongoing youth mental health crisis and support the President’s Unity Agenda for the nation. Task Force members also committed to future actions, including providing more resources for kids, teenagers and families, guidance for pediatricians and conducting more research.”
  • Healthcare Innovation lets us know,
    • “On July 17, the Office of the National Coordinator for Health IT (ONC) released the agency’s latest Data Brief and Quick Stat. According to ONC’s survey findings, 64 percent of U.S. hospitals plan to participate in TEFCA™, the Trusted Exchange Framework and Common Agreement. The agency notes that “This is an increase over 2022, when 51 percent of U.S. hospitals said they planned to participate.”
    • “Other findings:
      • “Approximately 7 out of 10 hospitals that participated in national networks or health information exchanges (HIEs) planned to participate in TEFCA, compared to 4 out of 10 hospitals that did not participate in either type of network.
      • “Hospitals with more resources, such as those that are larger, non-critical access, and affiliated with health systems, indicated greater awareness and had higher levels of planned participation in TEFCA when compared to smaller, critical access, and independent hospitals with fewer resources.
      • “The percent of hospitals that were aware of TEFCA but did not know if they would participate decreased from 23% to 9% from 2022 to 2023.”
    • FEHBlog Note — TEFCA is the government’s backbone for the healthcare electronic medical records system.

From the public health and medical research front,

  • The Washington Post reports,
    • “More than 40 percent of women said they skipped or delayed a screening recommended by a health professional, according to a recent survey by Gallup for the medical technology company Hologic.
    • “In the survey of 4,001 adult women across the United States, 90 percent of respondents agreed that it is important to get regular preventive health screenings for cancer, heart disease, sexually transmitted infections and other key health conditions. But 43 percent also said they skipped or delayed a recommended screening, including for breast cancer, cervical cancer and colorectal cancer.
    • “The respondents cited multiple reasons for doing so: anxiety about medical tests, pain concerns, cost, lack of time or not believing a screening was necessary.
    • “In addition, only 42 percent of the participants said they were “very confident” about which health screenings they needed. Many women also had trouble finding pertinent information, with 31 percent of Gen Z women saying it was hard for them to find relevant health information.”
  • Medscape tells us,
    • “Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.
    • “A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.” * * *
    • “Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” said Millennium Health Chief Clinical Officer Angela Huskey, PharmD, in a press release.”

From the U.S. healthcare business front,

  • Fierce Healthcare names the most influential minority executives in healthcare. Kudos to that group.
  • Beckers Payer Issues points out recent physician hires to executive roles at payer organizations.
  • Fierce Healthcare informs us,
    • “Embattled Steward Health Care has canceled auctions for its hospitals in Ohio and Pennsylvania after it did not receive qualified bids for those facilities, according to a court filing.
    • “The health system said in a document filed Sunday with bankruptcy court in Texas that it is working to determine alternatives for those facilities and expects to make an announcement at a later date. It had initially set a bid deadline for June 24 for these assets, which was later pushed back to July 15.
    • “Steward filed for chapter 11 bankruptcy in the Southern District of Texas in May.”
  • Fierce Healthcare also relates,
    • “Cigna has created a new impact fund that aims to address health disparities commonly impacting local communities.
    • “The insurer’s philanthropic arm, the Cigna Group Foundation, will operate the Cigna Group Health Equity Impact Fund. Through the program, Cigna will contribute $9 million over the next three years to tackle disparities and inequities across priority states.
    • “According to an announcement, the program will initially focus in Houston, Texas and Hartford, Connecticut. By drilling down to these specific communities, Cigna said it can “optimize” the level of assistance needed to put toward the unique equity challenges they’re facing.”

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.”

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, NIH, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fierce Healthcare tells us
    • “A bipartisan quartet of House representatives have introduced a bill peeling back restrictions on new or expanded physician-owned hospitals.
    • “The Physician Led and Rural Access to Quality Care Act, brought late last week, would create an exception to an Affordable Care Act’s ban that aimed to reduce conflicts of interest in care. Specifically, it would permit new physician-owned hospitals to open in rural areas that are at least 35 miles from another existing hospital or critical access hospital (or 15 miles in difficult-to-traverse areas).
    • “The new bill would also sunset a prohibition on expanding any existing physician-owned hospitals.”
    • FEHBlog note: The bill pits the American Medical Association (pro) against the American Medical Association (con).
  • Per a Department of Health and Human Services press release,
    • “Today, CMS is releasing the final part two guidance – PDF regarding plan outreach and education for the Medicare Prescription Payment Plan, which aims to ensure that people with Medicare prescription drug coverage, especially those most likely to benefit, are aware of the payment option. Starting in 2025, the Medicare Prescription Payment Plan provides the option to people with Medicare prescription drug coverage to spread the costs of their prescription drugs over the calendar year rather than paying in full at the pharmacy counter each time they fill a prescription. People with Medicare must opt into the Medicare Prescription Payment Plan to utilize the new benefit. Notably, this payment option launches at the same time that all individuals with Medicare prescription drug coverage will begin to have their annual out-of-pocket prescription drug costs capped at $2,000, providing needed financial relief for high prescription drug costs.” * * *
    • “Today’s Medicare Prescription Payment Plan final part two guidance, which complements the final part one guidance – PDF released on February 29, is also accompanied by the release of the final Medicare Prescription Payment Plan model materials. Medicare Part D plans can use the model materials when communicating to Part D enrollees about the Medicare Prescription Payment Plan.” * * *
    • “For the fact sheet on the final part two guidance for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/fact-sheet-medicare-prescription-payment-plan-final-part-two-guidance.pdf – PDF
    • “For the updated Information Collection Request (ICR) for the Medicare Prescription Payment Plan model plan materials, please visit: https://www.cms.gov/files/zip/medicare-prescription-payment-plan-model-materials.zip
    • “For an updated implementation timeline for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/medicare-prescription-payment-plan-timeline.pdf – PDF“
  • Another HHS press release brings us up to date on improvements to the 988 mental health lifeline which was launched two years ago today.
  • Healio adds,
    • “Since the launch of the 988 Suicide & Crisis Lifeline in 2022, counselors have answered more than 10 million calls, texts and chats from people seeking help for suicidal thoughts and mental health crises, according to HHS officials.
    • “During a press conference, HHS Deputy Secretary Andrea Palm said the lifeline “has become one of the most effective first-line responses that we have to help individuals who feel alone and without options.” * * *
    • “HHS has invested nearly $1.5 billion into the lifeline, according to an agency press release. It has lines that are tailored to people who speak Spanish, veterans, American Sign Language (ASL) users and the LGBTQI+ community. Since these lines were added to the 988 lifeline in 2023, there have been about 20,000 chats and texts with Spanish speakers, more than 475,000 texts, calls and chats with LGBTQI+ individuals and approximately 20,000 videophone contacts with ASL users.
    • “Among all contacts over the past 2 years, about 1.7 million were texts, according to the release. In the past year, HHS reported a 51% increase in texts and a 34% increase in calls, with support provided by more than 200 contact centers nationwide.”
  • CMS shares the following statement from CMS Administrator Chiquita Brooks-LaSure:
    • “Remembering Gail R. Wilensky, Ph.D., a health care policy savant who knew how to work across the aisle. Her Influence and leadership can still be felt today. She was very generous to the CMS leaders who served after her, including me. My deepest condolences to her loved ones. CMS is grateful for her service to our country.”
    • FEHBlog note — Dr. Wilensky, who passed away on July 11 at age 81, served as CMS (then HCFA) Administrator for President George H. W. Bush.
  • Per the AHA News,
    • “The AHA July 16 urged the Center for Medicare and Medicaid Innovation not to implement its newly proposed Increasing Organ Transplant Access Model as currently constructed, expressing concerns about many of its design features. The proposed mandatory payment model would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals would increase access to kidney transplants while preserving or enhancing the quality of care and reducing Medicare expenditures. AHA said that IOTA features could exacerbate inequities and negatively impact quality of care. Specifically, AHA said the IOTA model would add unnecessary disruption and uncertainty to the transplant ecosystem, potentially incentivize sub-par matches given the heavy emphasis on volume and would be discordant with other regulatory requirements.” 

From the public health and medical research front,

  • Per a press release, the Institute for Clinical and Economic Review published its Final Evidence Report on Treatment for Chronic Obstructive Pulmonary Disease 
    • “Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ensifentrine added to maintenance therapy compared to maintenance therapy alone; ICER calculated a health-benefit price benchmark (HBPB) for ensifentrine between $7,500 to $12,700 per year, and the therapy is priced at $35,400 per year.
  • The National Institutes of Health announced,
    • “In a new analysis of data, researchers at the National Institutes of Health (NIH) have found that taking a daily supplement containing antioxidant vitamins and minerals slows progression of late-stage dry age-related macular degeneration (AMD), potentially helping people with late-stage disease preserve their central vision. Researchers reviewed the original retinal scans of participants in the Age-Related Eye Diseases Studies (AREDS and AREDS2) and found that, for people with late-stage dry AMD, taking the antioxidant supplement slowed expansion of geographic atrophy regions towards the central foveal region of the retina. The study was published in the journal Ophthalmology.
    • “We’ve known for a long time that AREDS2 supplements help slow the progression from intermediate to late AMD. Our analysis shows that taking AREDS2 supplements can also slow disease progression in people with late dry AMD,” said Tiarnan Keenan, M.D., Ph.D., of NIH’s National Eye Institute (NEI) and lead author of the study. “These findings support the continued use of AREDS2 supplements by people with late dry AMD.”
  • Beckers Hospital Review shares ophthalmologist organization opinions on eye conditions and Ozempic use.
    • A week after a study connected Ozempic and Wegovy to an eye condition that can cause partial blindness, two ophthalmology organizations said they have “been aware of other vision changes for some time.”
    • Changing sugar levels can affect the shape of the eye’s lens, according to the American Academy of Ophthalmology and North American Neuro-Ophthalmology Society. Because of this, semaglutide, the active ingredient of Type 2 diabetes drug Ozempic and weight loss medication Wegovy, might lead to blurry vision. 
    • The ophthalmology groups said previous studies have also found that semaglutide can exacerbate diabetic retinopathy and macular complications. 
    • “The medical community has been aware of other vision changes with semaglutide for some time,” the organizations said in a July 8 joint statement. However, the research associating the drug to non-arteritic anterior ischemic optic neuropathy [NAION] is the first of its kind. 
    • “The condition restricts blood flow to the optic nerve, which causes sudden, painless loss of vision in one eye, the statement said. The research did not confirm a causal relationship between the medications and NAION, but it identified a potential link.: * * *
    • “The subjects in this study were either overweight or obese or had Type 2 diabetes. People who have diabetes are already at risk of NAION,” the organizations said. “Other risk factors for NAION include heart disease, history of heart attack, high blood pressure and sleep apnea” — health risks that also are tied to diabetes and obesity. 
    • “In response to the study, Novo Nordisk, the manufacturer of Ozempic and Wegovy, said it takes adverse event reports seriously. 
    • “The ophthalmology groups said they recommend patients continue taking the medications unless they experience a sudden vision loss.”  
  • The AHA News points out,
    • “Antimicrobial-resistant infections remained above pre-pandemic levels in 2022, the Centers for Disease Control and Prevention reported July 16. CDC data show that infections, which increased 20% during the pandemic compared to the pre-pandemic period — peaked in 2021.
    • “The increases in antimicrobial resistance (AR) burden seen in 2020 and 2021 are likely due in part to the impact of COVID-19, which pushed healthcare facilities, health departments and communities near their breaking points,” the agency notes. “This resulted in longer hospital stays for hospitalized patients (including those diagnosed with COVID-19), challenged the implementation of infection prevention and control practices and increased inappropriate antibiotic use.” 
    • “The AHA provides resources which promote the appropriate use of medical resources.”
  • Medscape summarized the June meeting decisions of the CDC’s Advisory Committee on Immunization Practices and identifies the five immunizations that adults need beyond Covid and the flu vaccines.
  • Medscape also discusses the use of remote trials to accelerate the testing of new long Covid treatments.

From the U.S. healthcare business front,

  • Beckers Payer Issues and Fierce Healthcare report on UnitedHealthcare’s second quarter financial results announced today.
    • BPI – “UnitedHealth Group posted $4.2 billion in net income during the second quarter of 2024, a 23% decline year over year.
    • “The company said it has restored the majority of affected Change Healthcare services and has provided more than $9 billion in advance funding and loans to providers. The total full year impact of the breach is estimated at $1.90 to $2.05 per share, with the company raising the estimated total cost of the attack to around $2.45 billion.”
    • FH – “UnitedHealth saw an elevated medical loss ratio in Q2, and executives pointed to the Change Healthcare cyberattack as a key factor.
    • “UnitedHealthcare had an MLR of 85.1% in the second quarter, compared to 83.2% in the prior year quarter. The insurer called out multiple elements that contributed to the elevated ratio in its earnings call on Tuesday morning. For one, UHC CEO Brian Thompson said there’s a clear difference in coding intensity after the insurer ended care waivers offered following the cyberattack.
    • “Amid the cyberattack, UnitedHealth eased prior authorization and utilization management to support cash flow to providers.”
  • Beckers Hospital Review provides details on U.S. News and World Report’s latest U.S. hospital rankings by State and by specialty.
  • pwc reports,
    • “Commercial health care spending growth is estimated to grow to its highest level in 13 years, according to PwC’s newest research into annual medical cost trend. PwC’s Health Research Institute (HRI) is projecting an 8% year-on-year medical cost trend in 2025 for the Group market and 7.5% for the Individual market. This near-record trend is driven by inflationary pressure, prescription drug spending and behavioral health utilization.
    • “HRI is also restating the 2023 and 2024 medical cost trends as higher than previously reported based on the input of health plans we surveyed and their trend experience. This unfavorable trend reflects higher than expected utilization of glucagon-like peptide-1 (GLP-1) drugs as well as higher acuity (higher levels of care) inpatient and outpatient utilization. Inpatient and outpatient utilization were driven by demand from care deferred since the pandemic, which was met by newly created capacity as sites of care shifted to outpatient, professional and ambulatory care settings.
    • “The same inflationary pressure the healthcare industry has felt since 2022 is expected to persist into 2025, as providers look for margin growth and work to recoup rising operating expenses through health plan contracts. The costs of GLP-1 drugs are on a rising trajectory that impacts overall medical costs. Innovation in prescription drugs for chronic conditions and increasing use of behavioral health services are reaching a tipping point that will likely drive further cost inflation.
    • “Meanwhile, cost deflators are not enough to offset cost inflators. The growing adoption of biosimilar medications may provide some relief, while many health plans are looking inward to find opportunities across business operations to generate additional cost savings. Today’s medical cost trend is an urgent call to action for healthcare organizations to rethink their strategies to manage the total cost of care more effectively – a challenge that is inextricably linked to the broader challenge of affordability, defined by the Affordable Care Act as the percentage of a member’s household income used for healthcare expenses.”
  • FEHBlog note — OUCH!
  • MedCity News discusses the improving state of the digital health fundraising market.

Tuesday Tidbits

David Ermer–AHRQ, Congress, Medical / Rx research, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • This morning, the Federal Trade Commission released an interim staff report on its ongoing investigation of prescription benefit managers. The report was favorably received by Senators Wyden and Grassley. Healthcare Dive summarizes the report here.
  • The FEHBlog recalls when around 2009 the State of New York went after UnitedHealthcare for offering a for profit service that provided usual, reasonable and customary rates for out-of-network providers. In a legal settlement, UnitedHealthcare transferred the service to a new not-for-profit company called Fair Health. Meanwhile most health plans had switched to the Medicare Part RBRVS pricing as base for its UCR reimbursements. Nevertheless, Fair Health is still around.
  • Today, the American Hospital Association News tells us,
    • “An op-ed published July 9 in Modern Healthcare written by AHA President and CEO Rick Pollack and Catholic Health Association President and CEO Sr. Mary Haddad discusses why nonprofit hospitals need positive margins. The commentary piece seeks to add important context and education to the conversation around nonprofit hospitals’ community benefit, tax-exempt status and other issues, arguing that positive margins are necessary to maintain basic services and advance care for all patients and communities 24/7. “Barely making ends meet or operating at a financial loss should never be the goal or an acceptable status quo for any nonprofit healthcare organization,” Pollack and Haddad write. “It’s not just bad economics; it also impedes institutions’ ability to deliver services and improve health outcomes.”
  • If the regulators are considering taking a page out of the Fair Health playbook, consider this finding from a USC-Brookings report issued last September:
    • “Pre-tax operating margins for the three largest PBMs averaged a bit more than 4% of their revenues in 2022. Since PBMs’ revenues encompass both the administrative fees charged to PBMs and payers’ net payments for claims, this implies that even completely eliminating PBMs’ margins [a no-no] would only modestly reduce payers’ drug-related costs. Achieving larger reductions would require reducing the revenue captured by pharmacies or, particularly, manufacturers. Ultimately, the amount of revenue that manufacturers capture depends principally on the extent of intellectual property protections related to drugs and whether and how the prices that drug manufacturers receive are regulated.”
  • The healthcare industry is complex, to say the least, and there are no simple answers.

From the public health and medical research front,

  • “Did you know that the U.S. Preventive Services Task Force (Task Force) has a free app called Prevention TaskForce? This app can help healthcare professionals identify which screenings, counseling interventions, and preventive medications are right for their patients. It includes all current Task Force recommendations and can be searched by specific patient characteristics, such as age, sex/gender, and selected behavioral risk factors. Download the app, on mobile or desktop, to find the preventive services that can help keep your patients healthy.”
    • “For more information and to download the app, click here.”
  • STAT News reports,
    • “In a long-awaited study, patients in Australia will soon receive an IV infusion designed to transform their own immune cells into swarms of cancer-fighting drones.
    • “The trial, announced on Tuesday by Interius Biotherapeutics, will be the first to test what’s known technically as in vivo CAR-T therapy. Researchers have long hoped the approach could provide a potentially cheaper, safer, and more scalable version of the cell therapies that are curative for some blood cancer patients but remain out of reach for many. 
    • “Interius received regulatory clearance on June 28 and will dose up to 30 patients, beginning in the fall. It beat out several competitors, including one with over $1 billion in funding, to the first-in-human trial.  
    • “There are absolutely people alive out there today that would not have been without the CAR technology,” said Dora Mitchell, Interius’ senior vice president for operations. But the therapy is still only delivered in some places in the U.S. and Europe and almost nowhere else. “The vision that catalyzed the formation of Interius was: can we bring this to the masses?”
  • Healio informs us,
    • “There is insignificant evidence to support recommendations that children with autism will benefit from intensive interventions, according to the results of a meta-analysis published in JAMA Pediatrics.
    • “One of the study’s authors told Healio that in reviewing standard intervention recommendations for autism in children, she found that one recommended that children receive at least 20 hours or up to 40 hours of intensive intervention per week.
    • “This recommendation originated initially from a quasi-experimental study conducted in the ’80s that, although remarkable for the time, was flawed,” Micheal P. Sandbank, PhD, director of The Brain and Language Lab at the University of Texas at Austin, told Healio. “There have been additional studies since then, but most were quasi-experimental and compared intensive intervention with different uncontrolled supports, failing to isolate the effect of intensity specifically from the effect of providing a systematic and comprehensive intervention approach.”
  • The Washington Post explains what to know about six popular home tests for urinary tract infections, menopause, allergies, colon cancer, A1c blood sugar and thyroid conditions.

From the U.S. healthcare business front,

  • Beckers Hospital CFO report informs us,
    • “Average hospital margins year to date remained steadfast in May at 3.8%, according to Kaufman Hall’s “National Hospital Flash Report,” released July 9.
    • “Hospital financial performance remained relatively unchanged during the month of May, and the rate of change slowed for margins and other key performance indicators, which reflects stabilization,” wrote Erik Swanson, senior vice president at Kaufman Hall.
    • “The stabilization is a positive sign for hospitals after ending the year with average margins at 1.9%. The average hospital margin shot up in January to 4.6% and then decreased slightly in February and March.
    • “From April to May, the monthly average operating margin index dipped from 4.2% to 3.7%. Operating margins increased 23% year to date over the same period last year.”
  • BioPharma Dive reports,
    • “Pfizer’s top scientist Mikael Dolsten is stepping down after leading the drugmaker’s research and development for the past 15 years, a period that includes Pfizer’s remarkable success developing a COVID-19 vaccine but ends with the company at a crossroads.
    • “On Tuesday, Pfizer said it has begun searching for a successor to Dolsten, who in 2010 became chief scientific officer as well as R&D head. The process is expected to last “probably through early next year,” Pfizer said.
    • “Dolsten will help with the search and continue to serve in his current position until a successor is in place and “any necessary transition is complete,” according to Pfizer.”