Midweek Update

Mental health care

Midweek Update

David Ermer–Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, NIH, OPM, U.S. Healthcare, Uncategorized–
Photo by Mel on Unsplash

From Washington, DC,

  • Here’s a link to a the brief text of Senate bill 4811 that would allow over 100,000 reservists and National Guard members who also are federal employees to transfer from the FEHB to the lower cost Tricare Reserve Select healthcare program effective January 1, 2025.
  • Kevin Moss, writing in Govexec, points out the advantages of FEHB high deductible health plans.
  • Beckers Hospital Review alerts us,
    • “A Senate committee opened an investigation into Novo Nordisk’s list prices for Ozempic and Wegovy, Novo Nordisk’s diabetes and weight loss drugs. 
    • “In an April 24 letter to Novo Nordisk’s CEO, the Senate Committee on Health, Education, Labor, and Pensions said Ozempic and Wegovy are “exorbitantly expensive,” which restricts access to the drugs for millions of Americans. 
    • “In the U.S., a four-week supply of Ozempic costs $969, and Wegovy is $1,349. That’s up to 15 times more than what Novo Nordisk charges in Canada, Europe and Japan, the letter said. 
    • “In 2023, pharmacies, clinics and hospitals spent more than $38 billion on the two products, which contain the same drug, semaglutide. They were the No. 1 pharmaceutical expense for U.S. healthcare, according to research published April 24.”
  • STAT News confirms,
    • “Spending on GLP-1 drugs like Ozempic and Wegovy ballooned last year and they’re set to cost the U.S. health care system and the federal government still more this year and beyond, two new reports released Wednesday show.
    • “One study from the American Society of Health-System Pharmacists found that GLP-1 treatments were a main driver of the increase in overall drug spending by health entities such as pharmacies and hospitals last year. In particular, expenditures on Novo Nordisk’s semaglutide — sold as Ozempic for diabetes and Wegovy for obesity — doubled to $38.6 billion, making the drug the top-selling medicine in 2023.
    • “The other report, by health policy research organization KFF, looked at the impact of the recent approval of Wegovy to prevent cardiovascular complications. Medicare is barred from covering drugs for weight loss purposes, but the new approval means the federal payer can now cover Wegovy when prescribed to reduce heart risks. As a result, Medicare could spend $2.8 billion in a year on the single drug, the researchers conservatively estimate.
    • “Taken together, the reports provide a window into the pressure that GLP-1 drugs could place on overall health care spending going forward, especially as more people take the medications. The treatments have been in short supply, but drugmakers are ramping up manufacturing capacity to meet the unprecedented demand from patients. The pharma companies are also seeking approval for even more indications like heart failure and sleep apnea.”
  • The New York Times reports,
    • “The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing suite of antimicrobial drugs.
    • “The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is often a first-line therapy for women with uncomplicated U.T.I.’s, meaning the infection is confined to the bladder and has not reached the kidneys. The drug will be marketed in the U.S. as Pivya and will be made available by prescription to women 18 and older. * * *
    • “Utility Therapeutics, the U.S. company that acquired the rights to pivmecillinam, said it would be available in 2025. The company is also seeking F.D.A. approval for an intravenous version of the drug that is used for more serious infections and is usually administered in a hospital setting.
    • “Health practitioners said they were elated to have another tool in their arsenal given the growing challenge of antimicrobial resistance, which makes existing medications less effective as pathogens mutate in ways that allow them to survive a course of antibiotics.”
  • As we learned yesterday, “Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.” MedCity News adds,
    • “Ojemda is available as an immediate-release tablet or an oral suspension, both administered once weekly. Dosing of the Day One drug is according to body surface area, which is consistent with dosing for other pediatric medications, Blackman said. Day One has set a $33,816 wholesale price for a 28-day supply. That means the annual cost of the therapy will top $440,000. Ojemda’s price is the same for all packages of the drug and will not change as a child grows and needs higher doses, Chief Commercial Officer Lauren Merendino said.
    • “The two formulations of Ojemda can be taken at home, which minimizes disruption to the lives of patients and families, Merendino said. Day One’s goal is to establish Ojemda as the physician’s first choice of therapy for pLGG. Merendino said the drug should become available in about two weeks.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Dairy cows must be tested for bird flu before moving across state lines, under a federal order issued Wednesday, as evidence mounts that the virus is more widespread than feared among cows in the United States.
    • Biden administration officials said the move is meant to contain transmission of the virus known as H5N1 and to reduce the threat to livestock, but they maintained that the risk to humans remains low. * * *
    • “An order issued by the U.S. Agriculture Department that takes effect Monday requires every lactating dairy cow to be tested before moving across state lines. Cows carrying the virus would have to wait 30 days and test negative before being moved, officials said. Positive test results would trigger additional requirements for herd owners to disclose information, including the movement of animals, to aid epidemiologic investigations, and for laboratories and state veterinarians to report cases to the USDA.
    • “Requiring positive test reporting will help USDA better understand this disease and testing before interstate movement will limit the spread of the virus,” Mike Watson, administrator of the USDA’s Animal and Plant Health Inspection Service, told reporters.
    • “This is an evolving situation, and we are treating it seriously and with urgency,” he said.”
  • The International Foundation of Employee Benefit Plans discusses “What Health Plan Sponsors Should Know About the Emerging Mental Health Needs of Youth.”
  • The National Cancer Institute released its latest Cancer Information Highlights.
  • The National Institutes of Health announced,
    • “In a proof-of-concept study, researchers demonstrated the effectiveness of a potential new therapy for Timothy syndrome, an often life-threatening and rare genetic disorder that affects a wide range of bodily systems, leading to severe cardiac, neurological, and psychiatric symptoms as well as physical differences such as webbed fingers and toes. The treatment restored typical cellular function in 3D structures created from cells of people with Timothy syndrome, known as organoids, which can mimic the function of cells in the body. These results could serve as the foundation for new treatment approaches for the disorder. The study, supported by the National Institutes of Health (NIH), appears in the journal Nature.
    • “Not only do these findings offer a potential road map to treat Timothy syndrome, but research into this condition also offers broader insights into other rare genetic conditions and mental disorders,” said Joshua A. Gordon, M.D., Ph.D., director of the National Institute of Mental Health, part of NIH.”
  • A primary care expert writing in Medscape offers a commentary on the new Shield blood test available for colon cancer screening.
    • “We will need to be clear [to patients] that the blood test is not yet endorsed by the USPSTF or any major guideline group and is a second-line test that will miss most precancerous polyps. As with the stool tests, it is essential to emphasize that a positive result must be followed by diagnostic colonoscopy. To addend the cancer screening maxim I mentioned before, the blood test is not the best test for CRC, but it’s probably better than no test at all.”
  • Health IT Analytics tells us,
    • “Researchers from the University of Virginia (UVA) have developed a machine learning tool designed to assess and predict adverse outcome risks for patients with advanced heart failure with reduced ejection fraction (HFrEF), according to a recent study published in the American Heart Journal.
    • “The research team indicated that risk models for HFrEF exist, but few are capable of addressing the challenge of missing data or incorporating invasive hemodynamic data, limiting their ability to provide personalized risk assessments for heart failure patients.
    • “Heart failure is a progressive condition that affects not only quality of life but quantity as well,” explained Sula Mazimba, MD, an associate professor of medicine at UVA and cardiologist at UVA Health, in the news release. “All heart failure patients are not the same. Each patient is on a spectrum along the continuum of risk of suffering adverse outcomes. Identifying the degree of risk for each patient promises to help clinicians tailor therapies to improve outcomes.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Prices for surgery, intensive care and emergency-room visits rise after hospital mergers. The increases come out of your pay. 
    • “Hospitals have struck deals in recent years to form local and regional health systems that use their reach to bargain for higher prices from insurers. Employers have often passed the higher rates onto employees. 
    • “Such price increases added an average of $204 million to national health spending in the year after mergers of nearby hospitals, according to a study published Wednesday by American Economic Review: Insights. 
    • “Workers cover much of the bill, said Zack Cooper, an associate professor of economics at Yale University who helped conduct the study. Employers cut into wagesand trim jobs to offset rising insurance premiums, he said. “The harm from these mergers really falls squarely on Main Street,” Cooper said. 
    • “Premiums are rising at their fastest pace in more than a decade, driven up by persistently high inflation across the economy. Rising costs have fueled contentious negotiations that have led some hospitals and insurers to cancel contracts, leaving patients in the lurch. 
    • “Hospital mergers make the price pressures worse.” 
  • Per BioPharma Dive,
    • “Biogen has seen “encouraging early trends” in the launch of its postpartum depression pill Zurzuvae, revealing in first quarter earnings drug sales that surpassed the estimates of Wall Street analysts.
    • “Biogen said sales of Zurzuvae between January and March hit $12 million, up from $2 million in the fourth quarter of 2023 and doubling consensus estimates of $5 million to $6 million. The company didn’t, however, reveal the number of prescriptions filled for Zurzuvae, making demand for the drug difficult to track. 
    • “Zurzuvae, which was discovered by Biogen partner Sage Therapeutics and approved by the Food and Drug Administration last August, is the only pill available specifically meant to treat postpartum depression, or PPD. But its sales prospects are uncertain, as the condition often goes undiagnosed, and many who are diagnosed don’t receive treatment.”  
  • STAT News tells us,
    • “A year ago, when Novo Nordisk announced it would cut the price of multiple insulin products by up to 75%, President Biden, lawmakers, and patient groups all counted the move as a win.
    • But several months later, Novo decided to discontinue one of those products, the basal insulin Levemir.
    • “Though the insulin won’t officially be off the market until the end of this year, patients are already running into supply disruptions and insurance cutoffs, leaving them with few options. The discontinuation, which is happening only in the U.S., has now drawn alarm from some Democratic senators, who sent a letter to Novo last week demanding an explanation.
    • “The turn of events highlights a key gap in policy efforts: Even if officials can get drugmakers to cut prices, the companies can choose to just pull a drug off the market, without guaranteeing that other manufacturers will continue to make the compound.”
  • Beckers Payer Issues informs us,
    • “Humana reported $741 million in net income in the first quarter of 2024. 
    • “The company published its first quarter earnings report April 24, beating investor expectations. In Q1 2023, Humana posted $1.2 billion in net income.
    • “Total revenue in the first quarter was $29.6 billion, up 10.7% year over year. 
    • “Humana’s medical loss ratio was 88.9% in the first quarter, which the company projects will rise to about 90% for the full year.”
  • Beckers Hospital Review notes,
    • “Cleveland Clinic’s eHospital program has expanded and now monitors 248 patient beds in ICUs and other units across the organization’s network.
    • “The eHospital program launched in 2014 as a pilot in one intensive care unit. The program is centered around a component known as the “bunker,” an operations center on Cleveland Clinic’s main campus. The operations center is staffed from 7 p.m. to 7 a.m. daily by a team consisting of two critical care nurses and a physician. Their primary responsibility is to monitor patients across various ICU units within the Cleveland Clinic network.”
  • and identifies the 25 most expensive hospital drugs.
    • “Keytruda (pembrolizumab) was nonfederal hospitals’ costliest drug expense in 2023, according to research published April 24 in the American Journal of Health-System Pharmacy. 
    • “In 2021 and 2022, COVID-19 drug Veklury (remdesivir) was the No. 1 pharmaceutical expense for the nation’s hospitals. Most medicines on the list saw modest changes from the prior year except for TNKase (tenecteplase), a cardiovascular therapy that cost hospitals 87.9% more in 2023.” 

Tuesday Tidbits

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

From Washington, DC,

  • Federal News Network lets us know,
    • “Enrollees in the Federal Employees Health Benefits (FEHB) program just began seeing better coverage of in-vitro fertilization (IVF) for the first time this year. But some members of Congress are looking to take things a step further.
    • “More than 175 House and Senate Democrats are urging the Office of Personnel Management to require every FEHB carrier to expand their offerings and cover costs for both infertility treatments and medications, starting in plan year 2025.
    • “That requirement “would reflect the reality that IVF is one of the most effective treatments for families struggling with infertility, and growing in popularity, with its usage nearly doubling from 2012 to 2021,” the lawmakers, led by Rep. Gerry Connolly (D-Va.) and Sen Tammy Duckworth (D-Ill.), wrote in a letter to OPM Tuesday.”
  • The Congressional letter does not reflect the fact that at least one option of many large FEHB plans do cover IVF treatments and likely more plans will offer that coverage for 2025 due to competition because growing families are good FEHB customers.
  • The Department of Health and Human Services released the 2024 National Strategy for Suicide Prevention (National Strategy) and accompanying Federal Action Plan. * * * To learn more about the 2024 National Strategy for Suicide Prevention and Federal Action Plan, visit www.hhs.gov/nssp.”
  • The Food and Drug Administration announced,
    • “a new initiative aimed to help reimagine the home environment as an integral part of the health care system. The Home as a Health Care Hub is intended to enable solutions that seamlessly integrate medical devices and health care, prevention and wellness into people’s lives and may: 
      • “Help medical device developers consider novel design approaches. 
      • “Aid providers to consider opportunities to extend care options and educate patients.
      • “Generate discussions on value-based care paradigms.
      • “Open opportunities to bring clinical trials and other evidence generation processes to underrepresented communities.”
  • The American Hospital Association News tells us,
    • “The Federal Trade Commission April 23 voted 3-2 to issue a final rule that would ban as an unfair method of competition contractual terms that prohibit workers from pursuing certain employment after their contract with an employer ends. The final rule does not apply to existing agreements with executives earning more than $151,164 annually who are in policymaking positions. In addition, although the Commission recognized that it does not have jurisdiction over not-for-profit entities, it reserved the right to evaluate an entity’s non-profit status and noted that some “entities that claim tax-exempt nonprofit status may in fact fall under the Commission’s jurisdiction.” Specifically, it stated that “some portion of the 58% of hospitals that claim tax-exempt status as nonprofits and the 19% of hospitals that are identified as State or local government hospitals in the data cited by AHA likely fall under the Commission’s jurisdiction and the final rule’s purview.”
    • “The rule takes effect 120 days after publication in the Federal Register and includes model language that employers can use to communicate to workers.  The United States Chamber of Commerce has already indicated that it will file suit to challenge the final rule.”
  • Healthcare Dive adds
  • HR Dive notes,
    • “The U.S. Department of Labor said Tuesday it will publish a final rule raising the Fair Labor Standards Act’s minimum annual salary threshold for overtime pay eligibility in a two-step process. Starting July 1, the threshold will increase from $35,568 to $43,888 per year. It will then increase to $58,656 on Jan. 1, 2025.
    • “The changes will expand overtime pay eligibility to millions of U.S. workers, the agency said. DOL’s 2025 threshold represents a jump of about 65% from the Trump administration’s 2019 rule and is slightly higher than the $55,068 mark that DOL proposed in 2023.
    • “The threshold will automatically update every three years using current wage data — which would next occur on July 1, 2027 —  but DOL said in the proposed rule that updates may be temporarily delayed if the department chooses to engage in rulemaking to change its methodology or update mechanism.”
  • Per FedWeek,
    • “The inspector general’s office at OPM has posted a warning against calling a phone number once associated with the agency’s Employee Express FEHB enrollment site (888-353-9450), saying the number “is currently in use by fraudsters/bad actors who have practiced financial exploitation tactics.”
    • “This phone number was provided on U.S. Department of State human resources notices to employees and Foreign Service retirees. It may also be or have been provided on other participating federal agencies’ human resources or information. This customer service phone number is no longer in use by OPM or the federal government,” it says.”

From the public health and medical research front,

  • The Wall Street Journal reports, “Removing ovaries with a hysterectomy might increase risk of heart disease, stroke and dementia.”
    • “A removal of the ovaries before menopause and before age 46 years may cause an acceleration of the aging processes across many organs, for example, the brain, and many tissues of the body, for example, the bones,” says Dr. Walter Rocca, who is a professor of epidemiology and neurology at the Mayo Clinic in Rochester, Minn., and has written studies on the topic. * * *
    • “Rocca was co-author of a 2021 Jama Network Open study that found that women under 46 who removed both of their ovaries with or without a hysterectomy had an increased risk of mild cognitive impairment and performed worse on cognitive tests 30 years later compared with women who didn’t undergo the procedure.
    • “Another study Rocca co-wrote found that women who had ovaries removed before age 50 faced higher risks for several conditions years later, including heart disease and osteoporosis.
    • Other studies have linked the procedures to an increased risk of dementia, Parkinson’s disease and accelerated aging.
    • “Sometimes, patients push to have their ovaries out at a younger age to help with symptoms such as pelvic pain or to avoid a subsequent surgery, says Dr. Daniel Breitkopf, chair of OB-GYN at Mayo Clinic and a member of ACOG’s board of directors. He usually advises waiting.
    • “I would rather do an oophorectomy five or 10 years later so then we have five to 10 years of benefit of those ovaries on your health,” he says.” 
  • The Washington Post informs us,
    • “Viral fragments of bird flu have been identified in samples of milk taken from grocery store shelves in the United States, a finding that does not necessarily suggest a threat to human health but indicates the avian flu virus is more widespread among dairy herds than previously thought, according to two public health officials and a public health expert who was briefed on the issue.
    • “The Food and Drug Administration said Tuesday that it had been testing milk samples throughout the dairy production process and confirmed the detection of viral particles “in some of the samples,” but it declined to provide details.
    • “The presence of genetic fragments of the virus in milk is not unexpected. Pasteurization typically works to inactivate pathogens, said Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health. It generally does not remove genetic material, Nuzzo said, but typically renders pathogens unable to cause harm to people.”
    • “The greater concern, however, “is that it’s showing up in a lot more samples, meaning the infection is more widespread in dairy herds than we thought,” said one public health official, who spoke on the condition of anonymity to share information not yet made public.”
  • STAT News tells us,
    • “Day One Biopharmaceuticals said Tuesday the Food and Drug Administration gave accelerated approval to its targeted pill for one of the most common forms of childhood brain tumors, pediatric low-grade glioma.
    • “The weekly pill, previously known as tovorafenib, will be marketed as Ojemda. These tumors generally regress when patients become adults, but toxic treatments are often needed to keep them at bay until then. The hope is that Ojemda can spare some children from, for example, radiation, which can devastate tumors but also healthy tissue throughout the brain and bring lifelong consequences.  * * *
    • “Day One plans to release a price Wednesday morning. 
    • “The authorization is particularly notable because industry has historically developed few drugs for children with cancer, instead focusing on adults, where there is a larger market.” 
  • Per BioPharma Dive,
    • “Neurocrine Biosciences, a drugmaker focused on the brain and nervous system, said Tuesday that one of its experimental medicines succeeded in a clinical trial evaluating it as a treatment for major depression.
    • “The medicine hit the Phase 2 trial’s main goal as well as “key secondary endpoints,” according to Neurocrine, which plans to meet with the Food and Drug Administration to discuss a path to late-stage testing. If positive results continue to pile up, the medicine could become the first of its kind to secure an approval.
    • “Eiry Roberts, Neurocrine’s chief medical officer, called the newly released data “very encouraging” and reflective of the medicine’s potential to alleviate many of the symptoms associated with major depressive disorder.”
  • HealthDay relates,
    • “The dangerous heart rhythm disorder called atrial fibrillation is becoming more common in middle-aged people, a new study warns.
    • “More than a quarter of patients at the University of Pittsburgh Medical Center (UPMC) seeking care for A-Fib during the last decade were younger than 65, researchers found.
    • “That’s much higher than the 2% prevalence of A-Fib commonly estimated among non-seniors, researchers said.
    • “Common knowledge among cardiologists is that, in people under 65, A-Fib is extremely uncommon and not detrimental. But there really hasn’t been any data to back that up,” said lead researcher Dr. Aditya Bhonsale, a UPMC cardiac electrophysiologist.
    • “The study also found that younger patients with A-Fib were more likely to die or to be hospitalized for heart failure, stroke or heart attack.”
  • Medscape discusses four recently FDA approved therapies that “are likely to be particularly important for primary care clinicians.” 

From the U.S. healthcare business front,

  • Health Payer Intelligence reports,
    • “Provider markups on specialty drugs increased 2024 commercial health insurance premiums by $13.1 billion, according to research from Oliver Wyman commissioned by AHIP.
    • “Provider-administered drugs can be delivered directly to providers from a specialty pharmacy—known as white bagging—or providers can purchase the drugs from the manufacturer or distributor and store the drug until the patient needs it, also called buy and bill.
    • “In the buy-and-bill method, hospitals and physicians can add a markup to the drug, which patients are responsible for paying. Delivering drugs through white bagging is generally more affordable for patients and payers because pharmacies do not add markup charges.
  • mHealth Intelligence relates, “Though telehealth utilization resulted in improvements in some healthcare utilization and quality measures, it was also linked to a 1.6 percent increase in healthcare spending, according to new research published in Health Affairs.”
  • STAT News adds,
    • “In the early days of the pandemic, as social distancing forced patients out of doctors’ offices, health care organizations scrambled to offer care online. In turn, health care accreditation organizations rushed to tweak their standards, filling a void in best practices for virtual visits.
    • “But as telehealth has matured, accreditation bodies — typically nonprofits that offer a seal of approval to organizations that pass their audits — are trying to address the nuance of digital care head-on. Today, the Joint Commission announced a new telehealth accreditation that will launch on July 1. Later that month, the National Committee for Quality Assurance plans to release its own virtual care standards, with applications for a new accreditation opening in November.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • ICER and NEWDIGS at Tufts Medical Center “have collaborated to publish a new white paper today that provides clear policy and market solutions to help manage the challenges of paying for gene therapies. The paper, entitled, “Managing the Challenges of Paying for Gene Therapy: Strategies for Market Action and Policy Reform,” was developed with input from a diverse set of patient advocacy groups, payer organizations, large and small biopharmaceutical manufacturers, providers, and others.”
    • “The specific policy reforms and market-based tools ICER and NEWDIGS identify in the paper are intended to help the US health system address these challenges to achieve more equitable and affordable access for patients to the growing number of gene therapies expected to be approved in the coming years. Options such as value-based pricing, value-based outcomes contracts, warranties, subscription insurance models, installment payment arrangements, and a federal carve-out benefit program are explored. For each option, the white paper analyzes the relative advantages and potential unintended consequences, along with suggestions for implementation, and an exploration of unique opportunities for combination or layered approaches.
    • “Gene therapies have the possibility to transform thousands of lives, but only if we ensure sustainable access to them for all patients,” said Sarah K. Emond, MPP, President and CEO of ICER. “It is incumbent upon the entire health care system to focus on innovative payment solutions that can address the challenges of paying for high-cost, one-time treatments. This paper should help stakeholders understand the menu of options available to move beyond responding to the high costs with reduced access, while meaningfully addressing the concerns around clinical uncertainty and budget impact.”
    • “Each condition, therapy and payer is unique, so a single solution cannot satisfy all situations,” said Mark Trusheim, Strategic Director of NEWDIGS. “With a menu of options which can be combined in a single contract or assembled from existing market offerings, each community can construct the most effective approach to ensuring appropriate patient access in their area.”
  • Reuters reports,
    • “Eli Lilly (LLY.N), said on Monday that it will acquire a manufacturing facility from Nexus Pharmaceuticals to produce injectable medicines.
    • “Lilly expects production at the facility based in Pleasant Prairie, Wisconsin, to begin at the end of 2025.”
    • “Soaring demand for GLP-1 agonists, a class of highly effective diabetes and obesity drugs which suppress appetite and promote a feeling of fullness, has led to constrained supply for drugmakers such as Lilly and Danish drugmaker Novo Nordisk.”
  • Beckers Payer Issues lets us know,
    • “A merger between Humana and Cigna could still be in the cards according to one analyst, Bloomberg reported April 22. 
    • “The math now works for a [Cigna and Humana] fusion,” Jeffries analyst David Windley wrote April 22. Since the two companies abandoned a proposed merger in December, Cigna’s stock prices have risen by 37% and Humana is down 31%, according to Bloomberg. 
    • “Cigna could strike a deal to acquire Humana for around $420 per share, Mr. Windley wrote in a note to clients. An acquisition would add to Cigna’s growth if it does not pay more than $470 per share for the company, according to Jeffries.” 
  • Per Fierce Healthcare,
    • “About a week ago, cybersecurity experts identified posts from the criminal group RansomHub that suggested the data from the Change Healthcare hack was up for sale.
    • “Those listings have since been pulled, according to a twitter post from Brett Callow, a threat analyst at Emsisoft. It’s unclear at present what led the group to suspend the sale, as they were seeking an additional ransomware payout from Change’s parent company UnitedHealth Group.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Healthcare Dive informs us,
    • “Providers and drugmakers are once again at odds over the 340B drug discount program: this time, over a rule finalized by the Biden administration on Thursday making changes to its dispute resolution process.
    • “The final rule, which will become effective in mid-June, is meant to make dispute resolution more accessible and efficient, according to the Health Resources and Services Administration, or HRSA, the agency that oversees 340B. Along with lowering barriers to enter the process, the rule requires parties to make a good faith effort to resolve disputes before bringing them to arbiters and creates an appeals process if either party doesn’t like the result.
    • “Provider groups the American Hospital Association and 340B Health said the rule should streamline the arbitration process and preserve the integrity of the controversial program. Meanwhile, pharmaceutical lobby PhRMA said the new process “panders to 340B hospitals” while ignoring drugmakers’ concerns.”
  • KFF lets us know,
    • “Federal data from 2019 shows just 4% of potentially eligible enrollees participated in the program, a figure that appears to have held steady through 2023, according to a Mathematica analysis. About 12,000 physicians billed Medicare under the CCM mantle in 2021, according to the latest Medicare data analyzed by KFF Health News. (The Medicare data includes doctors who have annually billed CCM at least a dozen times.)
    • “By comparison, federal data shows about 1 million providers participate in Medicare.
    • Even as the strategy has largely failed to live up to its potential, thousands of physicians have boosted their annual pay by participating, and auxiliary for-profit businesses have sprung up to help doctors take advantage of the program. The federal data showed about 4,500 physicians received at least $100,000 each in CCM pay in 2021. * * *
    • “This program had potential to have a big impact,” said Kenneth Thorpe, an Emory University health policy expert on chronic diseases. “But I knew it was never going to work from the start because it was put together wrong.”
    • “He said most doctors’ offices are not set up for monitoring patients at home. “This is very time-intensive and not something physicians are used to doing or have time to do,” Thorpe said.”
  • Reg Jones offers “A Refresher Course on FEGLI Life Insurance” in FedWeek.

From the public health and medical research front,

  • The Centers for Disease Control reports today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, 2 jurisdictions experienced high activity compared to 1 jurisdiction experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.  
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.” 
  • The National Institutes of Health announced,
    • “Despite Food and Drug Administration (FDA)-approval of seven next-generation antibiotics to fight infections caused by resistant “gram-negative” bacteria, clinicians frequently continue to treat antibiotic-resistant infections with older generic antibiotics considered to be less effective and less safe, according to a study by researchers at the National Institutes of Health’s (NIH) Clinical Center. Researchers examined the factors influencing doctors’ preference for newer antibiotics over traditional generic agents to shed light on the decision-making processes among clinicians when treating patients with challenging bloodstream infections caused by gram-negative bacteria and significant comorbidities.
    • “The study revealed that at a considerable proportion of hospitals, particularly smaller facilities located in rural areas, staff were reluctant to adopt newer antibiotics. Researchers identified a large cost disparity between older and newer classes of antibiotics; the newer drugs can cost approximately six times more than the older medications, which could disincentivize prescribing.
    • “Researchers also highlight that next-gen agents are prescribed more often at hospitals where lab results that show the medications are effective against a patient’s bacterial infection are reported to prescribers. Scientists suggest that earlier and more widespread availability of such lab testing might improve use. Additionally, authors recommend that future public health policies and economic strategies on further development and use of similar antibiotics should be designed to identify and overcome additional barriers.
    • “Gram-negative bacteria are a class of bacteria resistant to multiple drugs and increasingly resistant to most antibiotics. According to the Centers for Disease Control and Prevention, they are able to find new paths of resistant and pass along genetic material that enables other bacteria to become drug resistant.”
  • The American Hospital Association News adds,
    • “In clinical trials involving 220,000 patients at 59 HCA Healthcare hospitals, algorithm-driven computerized alerts helped clinicians better identify the appropriate antibiotic for 28% of patients with pneumonia and 17% of patients with urinary tract infections, according to studies funded by the Centers for Disease Control and Prevention published April 19 in JAMA. To reduce antibiotic resistance, physicians treating patients with a low risk for antibiotic-resistant bacteria were prompted to give standard-spectrum antibiotics.”In clinical trials involving 220,000 patients at 59 HCA Healthcare hospitals, algorithm-driven computerized alerts helped clinicians better identify the appropriate antibiotic for 28% of patients with pneumonia and 17% of patients with urinary tract infections, according to studies funded by the Centers for Disease Control and Prevention published April 19 in JAMA. To reduce antibiotic resistance, physicians treating patients with a low risk for antibiotic-resistant bacteria were prompted to give standard-spectrum antibiotics.
    • “Pneumonia and urinary tract infections are two of the most common infections requiring hospitalization and a major reason for overuse of broad-spectrum antibiotics,” said Sujan Reddy, M.D., medical officer in CDC’s Division of Healthcare Quality Promotion. “The INSPIRE trials have found a highly effective way to help physicians follow treatment recommendations to optimize antibiotic selection for each patient. These trials show the value of harnessing electronic health data to improve best practice.”
  • Health IT Analytics tells us,
    • “Artificial intelligence (AI)-driven tools can improve the skin cancer diagnostic accuracy of clinicians, nurse practitioners and medical students, according to a study published last week in npj Digital Medicine.
    • “The researchers underscored that AI-based skin cancer diagnostic tools are developing rapidly, and these tools are likely to be deployed in clinical settings upon appropriate testing and successful validation.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Alvotech and U.S. commercial partner Teva have signed a “long-term agreement” with an unspecified company to boost access to their biosimilar version of AbbVie’s blockbuster drug Humira, Alvotech said Friday. An Alvotech spokesperson declined to provide specifics.
    • “The deal comes seven weeks after the Food and Drug Administration approved Alvotech’s biosimilar, Simlandi, which the agency previously rejected multiple times. For patients to receive treatment, Alvotech and Teva must first cut deals with drug wholesalers, pharmacies and insurers that negotiate prices before agreeing to cover the therapy.
    • “CVS Health, whose pharmacy benefit manager is the country’s largest by prescription claims, removed Humira from its national formularyon April 1. Wall Street analysts have already reported substantial declines in Humira prescriptions over the last few weeks, when compared to the same period in 2023.”
  • According to Beckers Hospital Review,
    • “Change Healthcare has reinstated 80% of the functionality for its claims, payment and pharmacy services following a February ransomware attack, the company said.
    • “Those three areas represent most of Change Healthcare’s customers and continue to be restored, according to an April 16 earnings call from parent company UnitedHealth Group.
    • “Now we’ve still got work to do,” said Roger Connor, CEO of OptumInsight, the UnitedHealth unit that includes Change, during the call. “We’ve got another set of products coming online … in the coming weeks, but pleased with that progress.”
  • The AHA News reports,
    • “Patients went out-of-network 3.5 times more often to see a behavioral health clinician than a medical/surgical clinician in 2021, and up to 20 times more often for certain behavioral health visits, according to a new study by RTI International. For example, patients went out-of-network 8.9 times more often to see a psychiatrist, 10.6 times more often to see a psychologist, 6.2 times more often for acute behavioral inpatient care, and 19.9 times more often for sub-acute behavioral inpatient care.”
  • The Wall Street Journal reports,
    • “Social media is displacing physicians as the trusted authorities on whether patients should take one of the medicines. People are not only deciding to take a weight-loss drug—called GLP-1s— based on posts by friends and influencers but sometimes also skipping their doctor to go with one mentioned online.
    • “The virtual word-of-mouth can come across as authentic and accessible. People say they appreciate the tips and support they get from other online users. But many influencers and friends on social media play up all the pounds a person lost while playing down side effects that can be nasty, such as painful headaches and bouts of vomiting. Some omit the risks altogether.
    • “Unlike company drug advertisements, social-media posts don’t have to describe a drug’s side effects, suggest other resources or tell people to speak with their doctors.”
  • Ruh roh. This is why health plans are offering coaching services to these folks.

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The U.S. National Guard Association informs us,
    • “More than 100,000 drilling National Guardsmen and Reservists who are full-time federal employees would be eligible to purchase TRICARE Reserve Select health care under legislation introduced in both the House and Senate last week.
    • “Most drilling Guardsmen and Reservists have been able to buy low-cost TRS for more than 15 years. But the 2008 law that created the current program excluded these service members from the more-expensive Federal Employees Health Benefits program. This exclusion includes the Guard and Reserve’s dual-status technicians. And while a provision in the fiscal 2020 National Defense Authorization Act lifts this prohibition, the change does not take effect until 2030.
    • “The Servicemember Healthcare Freedom Act of 2024 would allow federal employees to enroll in TRS once the legislation is enacted. The bill was introduced by Sen. Richard Blumenthal, D-Conn., and co-sponsored by Sens. Kyrsten Sinema, I-Ariz., Tina Smith, D-Minn., and John Fetterman, D-Pa., in the Senate. Reps. Jen Kiggans, R-Va., and Andy Kim, D-N.J., introduced the measure in the House. Kim is the Democratic co-chair of the House National Guard and Reserve Caucus.
    • “The legislation affects roughly 113,000 Guardsmen and Reservists, according to a fact sheet from Blumenthal’s office. This figure includes approximately 67,000 Guard and Reserve dual-status technicians, who must be drilling service members to maintain their full-time employment.
    • “Cost is often the big difference between TRS and FEHBP. For example, the widely used FEHBP Blue Cross Basic Option costs $150 a month for a single adult, per Blumenthal’s office. The same TRS coverage is $51.95 a month. The average family of four spent $657.04 each month on health care though FEHBP last year, according to the same fact sheet. Family plans through TRS cost $246.87 a month. * * *
    • “TRS also provides continuity of care during service members’ mobilizations and demobilizations.”
  • The Office of Personnel Management issued a press release about a “New Benefits Administration Letter to Promote the Integrity of the Federal Employees Health Benefits Program.” This was the action discussed in Federal Times and Federal News Network articles that the FEHBlog discussed yesterday. The press release adds,
    • “OPM has proposed legislation in its FY2025 Congressional Budget Justification which would enable OPM consistent access to funds from the Employee Health Benefits Fund to build a Central Enrollment system for the FEHB Program. Current FEHB eligibility determination and enrollment is highly decentralized and requires cooperation between nearly 100 employing offices responsible for determining eligibility and enrolling more than 8 million members. These benefits are delivered by 68 health insurance carriers in 2024.     
    • “Since 2022, and following passage of the Postal Service Reform Act, OPM began developing the Postal Service Health Benefits Program to include a centralized enrollment platform. The PSHB accounts for more than 20 percent of current FEHB enrollees. If funded, OPM could extend this same central enrollment system to all FEHB enrollments, which would allow OPM to manage and make consistent all FEHB enrollments and remove individuals who cease to be eligible for the program. ”   
  • OPM also should provide carriers with HIPAA 820 electronic enrollment rosters to systematically reconcile premiums to individual enrollees, thereby assuring that each enrollee is paying the appropriate premium.
  • WTW, a major consulting firm, posted an article about the final 2025 notice of benefits and payment parameters which calls attention to a point on which the FEHBlog has not yet focused.
    • CMS adopted a rule to remove the regulatory prohibition on issuers from including routine non-pediatric dental services as an essential health benefit (EHB). This change would allow states to update their EHB-benchmark plans to add routine adult dental services as an EHB, removing regulatory and coverage barriers to expanding access to adult dental benefits. 
    • If a self-insured [or any FEHB] plan adopts a state benchmark plan that covers non-pediatric dental as an EHB and that plan covers non-pediatric dental, then the plan could not impose annual or lifetime dollar limits on that coverage (unless the coverage meets the requirements to be an excepted benefit or limited scope dental).
  • The American Hospital Association News reports,
    • “The Federal Trade Commission, Justice Department and Department of Health and Human Services April 18 launched HealthyCompetition.gov, an online portal for the public to report potentially unfair and anticompetitive health care practices. The FTC and the Justice Department’s Antitrust Division plan to review complaints for the appropriate agency to investigate if it raises sufficient concern under antitrust laws or HHS authorities.”
  • HR Dive tells us,
    • “The U.S. Supreme Court held Wednesday that employees challenging discriminatory transfers at work do not need to prove they suffered “significant” harm under Title VII of the Civil Rights Act of 1964; instead, they need only prove harm was done. 
    • “To demand ‘significance’ is to add words to the statute Congress enacted,” the high court ruled in Muldrow v. City of St. Louis. “It is to impose a new requirement on a Title VII claimant, so that the law as applied demands something more than the law as written. That difference can make a real difference for complaining transferees.”
    • “In the case, a police sergeant alleged she was transferred out of the intelligence division because of her sex and given less “prestigious” duties, a worse schedule and fewer job perks.”
  • The U.S. Census Bureau reports,
    • “The percentage of adults age 65 and older covered by both private health insurance and Medicare decreased from 47.9% in 2017 to 39.6% in 2022, reflecting older adults’ increased reliance on Medicare coverage alone.
    • “Dual coverage rates decreased almost every year during that period, except from 2020 to 2021, while rates of Medicare coverage alone significantly increased during the same period, from 37.6% to 44.8%, according to a new analysis of data from the 2023 Current Population Survey Annual Social and Economic Supplement (CPS ASEC). 
    • “Much of the increase in the share of older adults relying solely on Medicare was driven by a drop in the share of those also receiving private coverage.”
  • Although OPM waited much too long to allow FEHB plans the opportunity to offer Part D EGWPs, OPM to its credit has not followed the lead of many private employers which leave their retirees to Medicare alone.
  • The Social Security Administration has made available an interview with its new Commissioner Martin O’Malley who discussed his top priorities: “1) Reduce call wait times, 2) Issue faster disability decisions, 3) Resolve inequities in overpayments and underpayments.”

From the public health and medical research front,

  • Per MedPage Today,
    • “The CDC and FDA are warning about a multistate outbreak of Salmonella typhimuriumopens in a new tab or window infections linked to fresh basil sold at Trader Joe’s stores in over two dozen states.
    • “Twelve cases have been reported across seven states as of April 17, including one hospitalization. Exposure to fresh organic basil from Trader Joe’s prior to illness was confirmed in seven of eight individuals with additional case information.
    • “Miami-based Infinite Herbs, which makes the basil, has agreed to a voluntary recall, and the herbs have been pulled from store shelves.
    • “If you already bought organic basil from Trader Joe’s and removed it from the packaging or froze it and cannot tell if it was Infinite Herbs-brand, do not eat or use it and throw it away,” the FDA said in its statementopens in a new tab or window.
    • “The product was sold in a 2.5-oz clamshell-style container at Trader Joe’s stores in Washington, D.C., and 29 statesopens in a new tab or window, with most east of the Mississippi River. Cases have been reported in Florida, Georgia, Minnesota, Missouri, New Jersey, Rhode Island, and Wisconsin.
    • “An investigation is ongoing to determine whether additional products are linked to the illnesses, the FDA noted.”
  • The NIH Director, in her blog, pointed out,
    • “Pregnancy and childbirth are often thought of as joyful times. Yet, we know that mental health conditions including perinatal depression, anxiety, and post-traumatic stress disorder (PTSD) are common complications during and after pregnancy, and this is contributing to a maternal health crisis in this country.
    • “Now, a trio of NIH-supported studies reported in the journal Health Affairs show that diagnosis and treatment of mental health conditions such as anxiety, depression, and PTSD during pregnancy and in the first year after giving birth rose significantly in Americans with private health insurance from 2008 to 2020. While these are encouraging signs of increasing mental health awareness and service use, these studies also showed that this increase hasn’t happened equally across all demographic groups and states, making it clear there’s more work to do to ensure that people from all walks of life have access to the care they need, regardless of their race, ethnicity, geographic location, financial status, or other factors. * * *
    • “It will be important to learn in future studies more about those who may still not be receiving the mental health care they need. The researchers report plans to look deeper into changes that have taken place at the state level and the impact of the pandemic and the rise of telehealth since 2020. Other recent NIH-supported research suggests that relatively straightforward interventions to reduce postpartum anxiety and depression can be remarkably effective. The key step will be not only identifying interventions that work, but also figuring out how to deliver effective treatments to the people who need them.”
  • According to BioPharma Dive,
    • “Cerevel Therapeutics, a biotechnology company in the midst of being acquired by AbbVie, on Thursday said a Parkinson’s disease treatment it’s developing succeeded in a late-stage clinical trial.
    • “The treatment, called tavapadon, helped keep the disease’s disruptive motor fluctuations at bay, extending the total time of symptom control by just over one hour, compared to a placebo. This difference in “on” time was statistically significant, Cerevel said.
    • “Tavapadon also significantly reduced the amount of “off” time that treated study participants experienced, meeting a secondary goal of the Phase 3 study. People with Parkinson’s often cycle between these “on” and “off” periods as the effects of mainstay drugs like levadopa and carbidopa wane. In Cerevel’s study, tavapadon was given as an adjunctive therapy, meaning it was added on top of levadopa.”
  • The Washington Post reports,
    • “The nation’s largest coalition of obstetricians issued an urgent warning Thursday calling on doctors to expand testing for syphilis during pregnancy amid a surge of cases in recent years.
    • “The American College of Obstetricians and Gynecologists updated its recommendations, advising a routine blood screening at the first prenatal visit and screenings in the third trimester of pregnancy and at birth. This contrasts with previous recommendations, which called for testing in the third trimester exclusively for individuals living in communities with high syphilis rates and for those at risk of syphilis exposure during pregnancy.
    • “We’re always trying to create healthier families, and some of the diseases that we can easily diagnose and treat are things that we should prioritize, especially when they can be devastating to a baby,” said Laura E. Riley, chair of the obstetrician coalition’s immunization work group. Riley helped write the guidance. * * *
    • “In April 2023, the Food and Drug Administration announced a shortage of penicillin in the United States attributed to increased demand.
    • “To combat the ongoing shortages, the FDA granted temporary approval for a French drug, Extencilline, which is used for syphilis treatment but is not FDA-approved. While the Food, Drug, and Cosmetic Act prohibits importing unapproved drugs into the United States, the secretary of Health and Human Services can authorize temporary importation and distribution of such drugs to address shortages until domestic production returns to normal levels.
    • “Riley said the updated guidance from the obstetricians group is essential because it makes physicians aware of the alternative treatment for syphilis amid the shortage.
    • “In June 2023, the maker of penicillin, Pfizer, said it would prioritize making the drug available, with the shortage expected to be relieved within the next few months of this year.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “Elevance Health posted $2.2 billion in net income during the first quarter, a nearly 13% increase compared to the same period last year, according to the company’s earnings report published April 18.
    • “First quarter results reflect disciplined execution of our strategic initiatives during a dynamic time for our industry,” President and CEO Gail Boudreaux said. “We are making significant progress expanding Carelon’s capabilities, scaling our flywheel for enterprise growth, and delivering results for all stakeholders. Given the solid start to the year, we have increased our outlook for full year earnings.”
    • “Total revenues in the first quarter were $42.6 billion, a 1% increase year over year.
    • “Total expenses in the first quarter were $39.6 billion, a 0.2% increase.
    • “Net income was $2.2 billion in the first quarter, up 12.9% from the same period last year. 
    • “Elevance raised its full-year earnings outlook to $37.20 in earnings per share.”
  • Modern Healthcare lets us know,
    • “CVS Health is opening Oak Street Health primary care clinics at its retail pharmacy stores — a move that hasn’t always worked out for competitors.
    • “CVS acquired primary care provider Oak Street last May for $10.6 billion and announced plans to add 50 to 60 Oak Street clinics in 2024. Most of those clinics are expected to be standalone locations, including some located in closed CVS stores. But CVS also is piloting a setup that replaces much of the retail space in existing stores with clinics.
    • “Walgreens executives say they remain confident in the VillageMD investment, although the focus has shifted away from expansion and more toward ramping up profitability in VillageMD’s strongest markets.
    • “CVS may have a different experience. Its expansion plan for Oak Street has a slower pace than what Walgreens tried, said Jack Slevin, vice president of healthcare services equity research at Jefferies. CVS’ model is dedicating a lot of space to the Oak Street clinics and pharmacy operations, which would allow for more patient volume, he said.
    • “[CVS is] giving them enough space that it feels like a true Oak Street location,” Slevin said. “If you look at the Walgreens strategy on the square footage side, it was very much more bolting on a smaller Village practice to a Walgreens store that was going to look very much the same.”
  • The FEHBlog also ran across the following consulting firm opinion pieces that are worth a gander:
    • A Brown and Brown paper on the role of employers in advancing health equity.
    • A RAND paper discussing why employers delay coverage for FDA newly approved drugs.
      • FEHBlog takeaway :”The FDA has steadily increased the speed at which it approves new drugs over the last two decades. In 2023, the agency approved 55 new drugs, up from 21 in 2003. The great majority of drugs are now approved through its accelerated program, leaving the FDA wide open to criticism that its standards are too low and that it is simply acting as a rubber stamp for pharmaceutical companies. Under the accelerated program, the FDA grants approval for the drug to be put on the market and later grants full approval after clinical trials confirm a drug’s effectiveness.”
    • A McKinsey Health Institute paper on improving mental health services for children.
      • “As part of the McKinsey Health Institute’s (MHI’s) Conversations on Health series, Erica Coe and Kana Enomoto, coleaders at MHI, discussed this challenge and how to prioritize the mental health needs of children and adolescents with Zeinab Hijazi, PsyD, the global lead on mental health at UNICEF.”

OPM Director Resigns

David Ermer–AHRQ, Congress, COVID-19 vaccine, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • Federal News Network reports,
    • Kiran Ahuja, director of the Office of Personnel Management, will be stepping down from her position in early May, OPM announced Tuesday. * * *
    • Ahuja decided to leave the position due to ongoing health concerns and a recent death in the family, an agency spokesperson said. Once Ahuja vacates her position as the top-most OPM official in the coming weeks, OPM Deputy Director Rob Shriver will begin serving as acting director. * * *
    • “Kiran leaves an incredible legacy as a strong and indefatigable champion of the 2.2 million public servants in the federal workforce,” OPM’s Shriver said in a statement. “Under Kiran’s leadership, OPM has bounced back stronger than ever and partnered with agencies across government to better serve the American people. Kiran represents the very best of the Biden-Harris administration, and I am honored to call her a dear colleague and friend.”
  • Here are links to today’s relevant House of Representatives Committee hearings — one “Examining Health Sector Cybersecurity in the Wake of the Change Healthcare Attack” and the other “ERISA’s 50th Anniversary: the Path to Higher Quality, Lower Cost Health Care.”
  • STAT News reports,
    • “President Joe Biden’s administration will help 50 countries identify and respond to infectious diseases, with the goal of preventing pandemics like the Covid-19 outbreak that suddenly halted normal life around the globe in 2020.
    • “U.S. government officials will offer support in the countries, most of them located in Africa and Asia, to develop better testing, surveillance, communication, and preparedness for such outbreaks in those countries.
    • “The strategy will help “prevent, detect and effectively respond to biological threats wherever they emerge,” Biden said in a statement Tuesday.
    • “The Global Health Security Strategy, the president said, aims to protect people worldwide and “will make the United States stronger, safer, and healthier than ever before at this critical moment.”
  • The Congressional Budget Office issued a report about past performance and future directions of Medicare Accountable Care Organizations.
  • One Digital tells us,
    • “The 2023 EEO-1 Component 1 data collection window opens on April 30, 2024 and ends June 4, 2024. Private-sector employers with 100 or more employees or federal contractors with 50 or more employees must submit workforce demographic data. The EEO-1 Component 1 report is a mandatory annual data collection. Covered employers must submit data by job category and sex and race or ethnicity to the Equal Employment Opportunity Commission (EEOC). Updates to the data collection will be posted to the EEOC’s dedicated EEO-1 Component 1 website.
    • “The 2023 EEO-1 Component 1 Instruction Booklet and 2023 EEO-1 Component 1 Data File Upload Specifications are available on the EEOC’s dedicated EEO-1 Component 1 website. Employers must file their information through the EEO-1 Component 1 Online Filing System (OFS) either through manual data entry or data file upload. The EEO-1 Component 1 online Filer Support Message Center (i.e., filer help desk) will also be available on Tuesday, April 30, 2024, to assist filers with any questions they may have regarding the 2023 collection.”

From the public health and medical research front,

  • Value Penguin lets us know,
    • “Some much-needed good news for U.S. citizens: Between the first quarters of 2021 and 2023, the national age-adjusted death rate fell by 17.7%, according to the latest ValuePenguin study.
    • “Our study also looked at death rates by cause and the leading causes by state. Perhaps unsurprisingly given increased vaccination access and herd immunity, COVID-19 deaths fell most precipitously over that time. Deaths from most other causes showed a decline, too.”
  • HHS’s Agency for Healthcare Quality and Research released a Medical Expenditure Panel Survey with the following highlights
    • “In 2021, the top 1 percent of the population ranked by their healthcare expenditures accounted for 24 percent of total healthcare expenditures, while the bottom 50 percent accounted for less than 3 percent.
    • “Persons in the top 1 percent expenditure tier had an average of $166,980 in healthcare expenditures in 2021, nearly $30,000 higher than in 2019 or 2018. In 2020, persons in the top 1 percent expenditure tier had average expenditures that were more than $20,000 higher than in 2019 or 2018.
    • “Persons aged 65 and older and non-Hispanic Whites were disproportionately represented in the top expenditure tiers. 
    • “Inpatient stays accounted for about 26 percent of healthcare expenses for persons in the top 5 percent expenditure tier.
    • “More than three-quarters of aggregate expenses for persons in the top 5 percent expenditure tier were paid for by private insurance or Medicare.
    • “Among adults in the top 5 percent expenditure tier, 78.1 percent had two or more priority conditions.”
  • MedPage Today relates,
    • “Independent reviewers confirmed a causal relationship between the first mRNA COVID-19 vaccines and myocarditis, and also determined that, more broadly, intramuscular shots can cause a series of shoulder injuries.
    • “At the same time, the National Academies of Sciences, Engineering, and Medicine (NASEM) committee rejected a causal relationship between the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 (Comirnaty and Spikevax, respectively) mRNA COVID vaccines and female infertility, Guillain-Barré syndrome, Bell’s palsy, thrombosis with thrombocytopenia syndrome (TTS), and myocardial infarction.”
  • According to the University of Minnesota’s CIDRAP,
    • “A study yesterday in JAMA Internal Medicine demonstrates that 22% of hospitalized adults aged 50 years or older with respiratory syncytial virus (RSV) infection experienced an acute cardiac event—most frequently acute heart failure (16%). Moreover, 1 in 12 of infected patients (8.5%) had no documented underlying cardiovascular disease.
    • “RSV is associated with annual totals of up to 160,000 US hospitalizations, 10,000 deaths, and $4 billion in direct healthcare costs among adults age 65 years or older.
    • “Despite evidence of considerable RSV-associated morbidity, mortality, and health care expenditure, the potential severity of RSV infection in adults has historically been underappreciated by public health professionals and clinicians,” the authors write. RSV is rarely tested for in the clinical settings, and symptoms usually mirror other respiratory diseases, they add.” 
  • and
    • “New research conducted at US primary and urgent care sites shows that antibiotics didn’t provide any benefit for patients with a cough caused by an acute lower respiratory tract infection (LRTI).
    • “In fact, the findings, published yesterday in the Journal of General Internal Medicine, show that receipt of an antibiotic was associated with a small but significant increase in the duration of cough overall compared with those who didn’t receive an antibiotic. Even for those patients with a confirmed bacterial infection, the time until illness resolution was the same whether or not the patients received an antibiotic.
    • “Patients who received an antibiotic also had a higher overall disease severity over the entire course of their illness compared with those who didn’t.
    • “The study authors say the results of the Enhancing Antibiotic Stewardship in Primary Care (EAST-PC) study, which is the largest observational study to date on LRTIs in US primary and urgent care settings, are yet another indication that clinicians should be more prudent about using antibiotics for LRTIs.”
  • BioPharma Dive informs us,
    • “An antipsychotic drug from Intra-Cellular Therapies appears to also work as an add-on therapy for depression, according to clinical trial results the New York-based biotechnology company released Tuesday.
    • “The large trial enrolled almost 500 patients with major depression and hit its main goal as well as “key secondary endpoints,” the company said in a statement. It found that, over a six-week period, depressive symptoms significantly declined in study volunteers given Intra-Cellular’s drug plus antidepressants compared to those given a placebo and antidepressants.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth estimates costs from the Change Healthcare cyberattack could reach $1.6 billion this year, executives said on Tuesday. However, the managed care giant maintained its full-year earnings guidance, suggesting the financial fallout from the attack on the massive claims clearinghouse may be less serious than feared.
    • “The hit comes from direct response efforts like recovering Change’s clearinghouse platform and paying higher medical costs after its insurance arm suspended some utilization management processes, in addition to the loss of Change’s revenue.
    • “In the first quarter alone, the cyberattack cost UnitedHealth $872 million, according to financial results posted Tuesday.”
  • Beckers Payer Issues adds,
    • “Rising medical cost trends aren’t going down, but they are stabilizing, UnitedHealth Group executives say. 
    • “CEO Andrew Witty told investors April 16 that pent-up demand and increased health system capacity following the COVID-19 pandemic drove rising costs through 2023, but the trend was a “one-off.” 
    • “We don’t see anything like that. We see much more stabilization. We haven’t seen a step-down from that trend, but we certainly see that kind of sustained activity without aggressive acceleration,” Mr. Witty said. 
    • “Every major insurer reported rising costs in the Medicare Advantage population in the last months of 2023. While a few insurers, including Humana and CVS Health, cut their 2024 earnings guidance based on the trend, UnitedHealth Group maintained it can weather the storm. 
    • “The company reported its first-quarter earnings April 16. UnitedHealthcare’s medical loss ratio was 84.3% in the first quarter, compared to 82.2% the year prior and down from 85% in the fourth quarter of 2023.”
  • and
    • “UnitedHealth Group plans to bring Change Healthcare back stronger than it was before it suffered the largest cyberattack in the history of the U.S. healthcare system. 
    • “On an April 16 call with investors, UnitedHealth Group CEO Andrew Witty said it is “important for the country” that UnitedHealth Group owns Change. 
    • “Without UnitedHealth Group owning Change Healthcare, this attack likely would still have happened. It would have left Change Healthcare, I think, extremely challenged to come back,” Mr. Witty said. “Because it is a part of UnitedHealth Group, we’ve been able to bring it back. We’re going to bring it back much stronger than it was before.” 
  • Medscape offers a slideshow on 2023 physician compensation.
  • Beckers Payer Issues notes,
    • “Elevance Health will enter a partnership with private equity firm Clayton, Dubilier & Rice to develop advanced primary care models. 
    • “The joint effort will operate across multiple states and commercial, individual, Medicare and Medicaid markets, according to an April 15 news release. The payer-agnostic platform will serve more than 1 million members, the companies said. 
    • “The deal is financed primarily “through a combination of cash and our equity interest in certain care delivery and enablement assets of Carelon Health,” according to the news release. The two companies did not disclose the financial terms of the deal, and it is not expected to have a material impact on Elevance’s 2024 earnings. 
    • “The partnership will bring together two CD&R assets, digital platform Apree Health and Florida-based provider group Millennium Physician Group, and Carelon Health. Several Carelon Health clinics, part of Elevance Health, will provide care to members with chronic and complex conditions.” 
  • Beckers Hospital Review lets us know,
    • “About nine months after the FDA fully approved an Alzheimer’s drug for the first time, the medicine is trudging through insurance barriers and hesitations from potential patients, the Chicago Tribune reported April 12. * * *
    • “One of its manufacturers, Eisai, predicted 10,000 patients would begin treatment by the end of March. Eisai executives have since backed away from that forecast, but they say sales are increasing, according to the Tribune. 
    • “CMS covers Leqembi, and so do about 75% of commercial plans in the U.S., a spokesperson for the drugmaker said. But, for the upwards of 6 million Americans who are diagnosed with Alzheimer’s disease, the medication has not made a splash as patients worry about side effects and contraindications.”
  • and
    • “Multiple April bankruptcy court filings revealed that Camp Hill, Pa.-based Rite Aid has plans to shutter 53 additional locations across nine states after it filed for Chapter 11 bankruptcy and shared it will close 154 locations last October. 
    • “The “notice of additional closing stores” filings, obtained by Becker’s, revealed the stores are located in Pennsylvania, New Jersey, New York, Ohio, California, Massachusetts, Michigan, Virginia and Maryland.” 

Monday Roundup

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

From Washington, DC,

  • Federal News Network tells us,
    • “The Biden administration has now ended many of the policies that previously dictated agencies’ health and safety responses to the COVID-19 pandemic. But for federal employees, the administration is still offering some on-the-job flexibility for the foreseeable future.
    • “One of the few remaining policies from a series of 2021 executive orders lets federal employees still take up to four hours of paid administrative leave to get COVID-19 vaccine booster shots, the Office of Personnel Management said in an April 12 memo.
    • “The administration strongly encourages federal employees to get recommended doses of updated COVID-19 vaccines even when receiving those vaccines is not a job requirement,” OPM Director Kiran Ahuja said in the memo addressed to agency heads. “Vaccines remain the best tool we have in our toolbox to combat COVID-19. They are safe, effective and free.”
    • “For federal employees, the offered administrative leave will cover the time it takes to get the COVID-19 booster shot, as well as feds’ travel time to and from the vaccination site. As is standard, employees should get approval from their supervisors before taking leave for this purpose, OPM said. Four hours is the maximum OPM is allotting, but federal employees should only take off as much time as they actually need to get the shot.”
  • OPM should take the same approach with cancer screening services, such as colonoscopies and mammographies.
  • The American Hospital Association News reports,
    • “The Change Healthcare cyberattack was a significant event that caught many off guard, said the Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure, reiterating the agency’s commitment to supporting impacted hospitals. Brooks-LaSure stated the Administration is listening to stakeholders and when possible, facilitating solutions, noting the importance of meeting the needs of providers.
    • “In addition, Brooks-LaSure celebrated important improvements CMS made to promote greater transparency for prior authorization criteria. CMS took steps earlier this year finalizing new regulations to streamline and reduce burden associated with the prior authorization process in Medicare Advantage and fee-for-service and managed care programs for Medicaid and the Children’s Health Insurance Program.  
    • “CMS continues to hear from patients and providers over some commercial insurer prior authorization denials and delays, Brooks-LaSure said, noting that the volume of frustration has “just exploded.” The private sector, she said, has an opportunity to step up with solutions of their own to address concerns.
    • “I’ve told the health plans this: it doesn’t have to all be regulated [by the federal government], there may be things that they can do,” Brooks-LaSure said.”
  • Beckers Payer Issues adds,
    • “AHIP’s chief executive criticized the hospital lobby’s response to the Change Healthcare cyberattack as “opportunistic” and “maintaining the status quo.”
    • “AHIP President and CEO Mike Tuffin pointed to comments that hospital lobbyists made to the media about the hack being “another talking point” to prevent health systems from implementing site-neutral payments, as well as an industry association’s opposition to cybersecurity mandates.
    • “Insisting on maintaining the status quo simply makes the healthcare system a more inviting target for the ever-more sophisticated hacking operations targeting the sector,” Mr. Tuffin wrote in the April 12 article. “Instead of taking a constructive leadership role in what can be done to protect consumers and the system moving forward, the hospital lobby chooses to use the moment to point fingers and shirk responsibility.”
    • “Rather than “playing politics,” all industry stakeholders should be focusing on preventing and preparing for future healthcare cyberattacks, he said.”
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission announced on Monday its final rule implementing the Pregnant Workers Fairness Act, clarifying that abortion is included under “pregnancy, childbirth or related medical conditions” that are protected under the PWFA.
    • “EEOC said this interpretation of the law’s text is “consistent with the Commission’s and courts’ longstanding interpretation of the same phrase in Title VII.” It also noted that employees are entitled to the law’s provisions even if they have not worked for an employer for a specific length of time.
    • “EEOC had originally slated the rule for publication at the end of 2023, but the commission’s deadline passed without a rule in place. The rule is scheduled to be published in the Federal Register Friday, and will take effect 60 days after publication, approximately mid-June.”
  • The Government Accountability Office released a report on selected States regulation of pharmacy benefit managers.

From the public health and medical research front,

  • The Washington Post considers why
    • “Rural Americans ages 25 to 54 — considered the prime working-age population — are dying of natural causes such as chronic diseases and cancer at wildly higher rates than their age-group peers in urban areas, according to the report. * * *
    • “The USDA researchers analyzed mortality data from the Centers for Disease Control and Prevention from two three-year periods — 1999 through 2001, and 2017 through 2019. In 1999, the natural-cause mortality rate for rural working-age adults was only 6 percent higher than that of their city-dwelling peers. By 2019, the gap had widened to 43 percent.” * * *
    • “The USDA’s findings were shocking but not surprising, said Alan Morgan, CEO of the National Rural Health Association. He and other health experts have maintained for years that rural America needs more attention and investment in its health care systems by national leaders and lawmakers.”
  • “MedPage Today editor-in-chief Jeremy Faust, MD, talks with Monica Bertagnolli, MD, the 17th director of the National Institutes of Health (NIH), about the day-to-day work at the NIH on pandemic preparedness, the importance of looking for new approaches to testing, and the status of long COVID research.”
  • Healio points out,
    • “Physical activity patterns that included vigorous exercise, housework or walking were associated with lower stroke risk.
    • “Watching TV and commuting were linked to higher risk for stroke.”
  • Per Medscape,
    • “Low- to moderate-intensity physical exercise in patients with severe mental illness is linked to improved medication adherence, regardless of medication type or duration of illness, new research shows.
    • “The positive association between adherence and moderate physical activity emphasizes that physical activity improves overall health and functional status. Promoting physical activity can be a valuable and integrated strategy that can be easily implemented into our routine clinical practice,” said study investigator Rebecca Silvestro, MD, Department of Psychiatry, Università degli studi della Campania Luigi Vanvitelli in Naples, Italy.
    • “The findings were presented at the European Psychiatric Association 2024 Congress.” 

From the U.S. healthcare business front,

  • STAT News reports,
    • “The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., surged to 36% from just 5% during the first week of April, thanks to the expanding reach that CVS Health has over the prescription drug market.
    • “The big jump was attributed to one particular biosimilar called Hyrimoz, which is manufactured by Sandoz, a former unit of Novartis that is a leading supplier of generic and biosimilar medicines. However, Hyrimoz is jointly marketed with Cordavis, a new subsidiary that CVS created last August specifically to sell any number of biosimilar medicines in the U.S.
    • “This connection is crucial to the sudden jump in Hyrimoz prescriptions. How so? On April 1, CVS Caremark, which is one of the largest pharmacy benefit managers in the U.S., removed Humira from its major national formularies for health plans that cover about 30 million lives. Formularies are the lists of medicines that are covered by health insurance.
    • “The move quickly shifted market share to Hyrimoz. During the week ending March 29, the number of new prescriptions written for the biosimilar was about 640, but rose to nearly 8,300 in the week ending April 5, according to a report to investors by Evercore ISI analyst Elizabeth Anderson. That pushed the share for all Humira biosimilars to 36%, with Hyrimoz contributing 93% of the growth.”
  • Health Leaders Media discusses three ways that independent physician practices can maintain their independence.
  • According to BioPharma Dive,
    • “Roche’s new dual-acting blood cancer drug Columvi combined with chemotherapy helped people with a type of lymphoma live longer than people given Rituxan and chemo, the company said Monday. The data could help Roche persuade the Food and Drug Administration to convert Columvi’s conditional OK into a full approval.
    • “Roche didn’t disclose full data from the Phase 3 “Starglo” trial in people with diffuse large B-cell lymphoma whose disease advanced after initial treatment and who weren’t eligible for stem cell transplants. The results will be presented at an upcoming medical meeting, the company said.
    • “Columvi is a new type of drug called a “bispecific” antibody that triggers an immune response to cancer cells. A competitor developed by Genmab and AbbVie has also gained accelerated approval and could have confirmatory data later this year, while the FDA rejected a bispecific from Regeneron because its confirmatory trial isn’t far enough advanced.”
  • MedTech Dive reports,
    • “Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday.
    • “Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type.
    • “Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company.”

Thursday Miscellany

David Ermer–CMS, FDA, Medical / Rx research, Medicare, Mental health care, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an HHS press release,
    • Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is finalizing policies that continue to strengthen enrollee protections and guardrails to ensure Medicare Advantage and Medicare Part D (Part D) prescription drug plans best meet the needs of people with Medicare. The Contract Year (CY) 2025 Medicare Advantage and Part D final rule builds on existing CMS policies to promote competition, increase access to care, including important behavioral health services, and protect individuals from inappropriate marketing and prior authorization. * * *
    • [For example,] CMS is finalizing greater flexibility for Part D plans to substitute, more quickly, lower cost biosimilar biological products (biosimilars) for their reference products so that enrollees may have faster access to equally effective, but potentially more affordable, drug treatment options. * * *
    • View a fact sheet on the final rule at cms.gov/newsroom.
  • From the AHA News,
    • “Primary care providers who commit to practicing two years in a health professional shortage area can initially receive up to $75,000 in loan repayment under the National Health Service Corps Loan Repayment Program, $25,000 more than previously and the first significant increase in 30 years, the Health Resources and Services Administration announced April 4. Participants who extend their service beyond two years can receive additional funding under the program. HRSA also will offer up to $5,000 in additional loan repayment to participants who can demonstrate fluency in Spanish and commit to practice in a high-need area serving patients with limited English proficiency.”
  • The International Foundation of Employee Benefit Plans lets us know,
    • “The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPAEA) requires group health plans that provide mental health or substance use disorder (MH/SUD) benefits to offer parity between coverage of physical health conditions and mental health conditions. The Department of Labor (DOL) Employee Benefits Security Administration (EBSA) enforces MHPAEA and reports annually to Congress on how agency investigators are working with plan sponsors and administrators to bring them into compliance.
    • “Recent DOL reports on MHPAEA enforcement indicate several pitfalls that self-funded plan sponsors and their administrative service providers should avoid in order to be compliant with mental health parity rules. A new priority in the 2023 report was impermissible exclusions of key treatments for MH/SUD.
    • One-Minute Summary
      • Recognize that autism spectrum disorder, opioid use disorder and eating disorders are mental health conditionsand therefore treatment of these disorders are mental health benefits covered by mental health parity laws.
      • Blanket exclusions of ABA therapy for autism spectrum disorder, nutritional counseling for eating disorders, and medication-assisted treatment (MAT) and medications for opioid use disorder (MOUD) are impermissible.
      • Methods that participants use to access care should be in parity. Prior authorization, gatekeepers such as EAP referrals and telehealth are impermissible barriers to access mental health benefits.
  • Per an OPM press release,
    • In the first week of the Biden-Harris Administration, President Biden revoked an Executive Order issued by the previous Administration that risked altering our country’s long-standing merit-based civil service system, by creating new excepted service schedule, known as “Schedule F,” and directing agencies to move potentially large swathes of career employees into this new excepted service status. This attempt would have stripped career civil servants of their civil service protections that ensure that decisions to hire and fire are based on merit, not political considerations.  
    • The [OPM] final rule [released today] advances these important policy goals by:  
      • Clarifying that the status and civil service protections an employee has accrued cannot be taken away by an involuntary move from the competitive service to the excepted service, or from one excepted service schedule to another. Once a career civil servant earns protections, that employee retains them unless waived voluntarily.  
      • Clarifying that the phrase “confidential, policy determining, policymaking, or policy-advocating” positions—a term of art to describe positions that lack civil service protections—means noncareer, political appointments. This rule prevents that exception from being misapplied to career civil servants.  
      • Establishing procedural requirements for moving positions from the competitive service to the excepted service and within the excepted service. This change both creates transparency and establishes an appeals process for federal employees when any such movement is involuntary and characterized as stripping employees of their civil service protections.   

From the public health and medical research front,

  • The Society for Human Resources Management tells us,
    • “Anxiety has skyrocketed in recent years, now becoming the top mental health issue plaguing workers, new data shows.
    • “An analysis of more than 300,000 U.S. cases from mental health provider ComPsych found that nearly a quarter of people (24 percent) who reached out to ComPsych for mental health assistance in 2023 did so to get help with anxiety.
    • “That makes anxiety the No. 1 presenting issue reported by U.S. workers, topping depression, stress, relationship issues, family issues, addiction and grief, ComPsych said.”
  • MedPage Today notes,
    • New U.S. hepatitis C infections dropped slightly in 2022, a surprising improvement after more than a decade of steady increasesopens in a new tab or window, federal health officials said Wednesday.
    • Experts are not sure whether the 6% decline is a statistical blip or the start of a downward trend. Seeing 2023 and 2024 data, when it’s available, will help public health officials understand what’s going on, said Daniel Raymond, director of policy at the National Viral Hepatitis Roundtable, an advocacy organization.
    • “We’ve had a decade of bad news … I am cautiously encouraged,” he said. “You always want to hope something like this is real, and a potential sign that the tide has turned.”
  • STAT News reports,
    • “The booming class of GLP-1 drugs that includes Ozempic and Wegovy is not only effective for diabetes and obesity, but is also showing early potential to help with conditions involving the brain, like mental health disorders, Alzheimer’s, and even, as new study results suggest — Parkinson’s disease.
    • “In a Phase 2 trial, patients with early Parkinson’s disease taking an older GLP-1 diabetes drug called lixisenatide experienced no worsening of motor symptoms over a year, in contrast to patients on placebo who did, according to the study, published Wednesday in the New England Journal of Medicine.
    • “The difference between the groups — as measured by a test looking at someone’s tremors and rigidity — was small, almost but not quite reaching what is deemed to be a clinically significant difference. Still, the authors said they were encouraged that patients on the drug did not get worse, and the findings add to a growing body of research that suggests this class of medications holds potential as a new way of addressing Parkinson’s, a slow-moving, debilitating disorder that currently lacks any treatments that can halt disease progression.”
  • and
    • “Moderna may be best known for its Covid-19 vaccine, but since its start, it’s always been set on developing therapies.
    • “It’s run into some hurdles as it’s pioneered turning mRNA — the strand of genetic material that’s at the heart of Moderna’s approach — into medicines. But the company’s vision of making cells into their own drug factories is showing signs of progress.
    • “On Wednesday, scientists reported interim results from an early study of Moderna’s most advanced rare-disease therapy, a treatment for propionic acidemia, a metabolic condition in which the body makes defective versions of enzymes that are required to break down fats and proteins. While the study primarily focused on safety and testing different doses, some patients — most of the participants were children — saw a reduction in the life-threatening metabolic emergencies that can crop up with the disease.
    • “And while most patients reported such side effects as fever and vomiting, they broadly wanted to stay on the drug even after the trial period wrapped up, according to the study, published in the journal Nature.”

From the U.S. healthcare business front,

  • American Hospital Association News informs us,
    • “Almost half of rural hospitals had negative total margins in 2022 and negative patient care margins both before and after the COVID-19 pandemic, according to a report prepared for the AHA by faculty at the Virginia Commonwealth University College of Health Professions. When provider relief funds are excluded from margins, the average total margin for rural hospitals was lower in 2022, the most recent year with data available, than in any year since 2017.” 
  • Mercer Consulting looks at the performance of exclusive provider organizations.
    • “We’re seeing growing adoption of network configurations that differ from the traditional broad PPO network. This might mean eliminating out-of-network benefits, offering a plan with a narrow network of high-performing providers, or both. According to our Survey on Health and Benefit Strategies for 2024, 24% of large employers (those with 500 or more employees) now offer a medical plan option with a High-Performance Network curated by a carrier. Most often, these are plans offered by a national carrier in which the providers are a subset of the carrier’s larger Preferred Provider Organization network and are selected based on quality and cost metrics. A few independent provider networks (for example, Centivo and Imagine Health) have gained some traction as well. The largest employers are moving the fastest – 38% of companies with 20,000 or more employees offer some type of high-performance network.” 
  • Healthcare Dive reports,
    • “Walmart is pushing back expansion plans for its health center superstores, as retail giants struggle to right-size their primary care networks.
    • “The company plans to open 22 health centers this year, according to a Walmart spokesperson. Previously, the retail giant said it would open more than 30 locations in 2024.
    • “Walmart plans to open 18 centers in Texas and another four in the Kansas City metro area, the spokesperson said. The clinic openings will start this month in Houston, and run throughout the fall.”
  • According to BioPharma Dive,
    • “Amylyx Pharmaceuticals is pulling from market one of the few approved treatments for ALS.
    • “Rarely do drugmakers voluntarily withdraw products. In Amylyx’s case, the decision comes just weeks after a large clinical trial meant to confirm the benefits of its medicine instead found it no better than a placebo at slowing the fatal, nerve-destroying disease.
    • “Starting Thursday, the medicine, which is sold as Relyvrio in the U.S. and Albrioza in Canada, will no longer be available for new patients. Those who are taking it and wish to continue may enter a free drug program. Additionally, a phase of that large trial that allows participants to continue on Relyvrio remains ongoing.”
  • MedTech Dive points out,
    • “The Food and Drug Administration granted de novo clearance to an AI tool to help clinicians predict and diagnose sepsis, the first time the agency has authorized such a tool.
    • “The Sepsis Immunoscore software, developed by Chicago-based Prenosis, provides a risk score for clinicians on a patient having or developing sepsis within 24 hours. The score is based on 22 parameters, including respiratory rate, blood pressure and white blood cell count. 
    • “Hospitals already use early sepsis detection tools, despite lacking FDA review. The agency clarified in a final guidance in 2022 that clinical decision support software that provides a risk score or probability of a condition should be regulated as a medical device.”

Monday Roundup

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

From Washington, DC,

  • American Hospital News tells us,
    • “The Centers for Medicare & Medicaid Services April 1 finalized proposed changes to Medicare Advantage plan capitation rates and Part C and Part D payment policies for calendar year 2025, which the agency estimates will increase MA plan revenues by an average 3.7% from 2024 to 2025.
    • “The notice implements expected changes to the Part C risk adjustment model that were finalized in the CY 2024 final rule and are being phased-in over three years, such as transitioning the model to reflect ICD-10 condition categories and using more recent data available for fee-for-service diagnoses and expenditures, in addition to providing technical updates to the methodology for CY 2025.
    • “It also finalizes technical updates to the Part C and D star ratings; includes certain adjustments to provide stability for the MA program in Puerto Rico; and implements changes to the standard Part D drug benefit required by the Inflation Reduction Act of 2022, including capping annual out-of-pocket costs for people with Medicare Part D at $2,000 in 2025.” 
  • Per an AHIP press release,
    • “Following the release of the final Medicare Advantage and Part D rate notice from the Centers for Medicare & Medicaid Services (CMS), AHIP President and CEO Mike Tuffin issued the following statement:
      • “These policies will put even more pressure on the benefits and premiums of 33 million Medicare Advantage beneficiaries who will be renewing their coverage this fall. It is important to note that the Medicare Advantage and Part D programs are already undergoing a number of significant regulatory and legislative changes. Moreover, the cost of caring for Medicare Advantage beneficiaries is steadily rising.
      • “Over the past several weeks, scores of bipartisan members of Congress and a diverse array of stakeholders have reinforced their strong support for Medicare Advantage. We appreciate these policymakers and organizations who stood up for the high-quality, affordable coverage and care seniors and people with disabilities count on in Medicare Advantage.”
    • “To view AHIP’s comment letter to CMS, click here.”
  • BioPharma Dive identifies five FDA decisions to watch in the second quarter of 2024, which began today.
  • Federal News Network tells us,
    • “The National Association of Letter Carriers tracks about 150 of these acts of heroism from its members every year. But each year, the union recognizes a select few for extraordinary acts of service.”The National Association of Letter Carriers tracks about 150 of these acts of heroism from its members every year. But each year, the union recognizes a select few for extraordinary acts of service.
    • “Some of NALC’s Letter Carrier Heroes of the Year put their own safety on the line to help save lives. Others led toy drives in their community and held annual charity concerts to make the holiday season extra special for families in need.
    • “NALC National President Brian Renfroe said letter carriers provide an essential service to their customers, and are the “eyes and ears of their communities.”
    • “No one knows our communities and our neighborhoods like letter carriers. We deliver on our routes six and even seven days a week. We get to know our customers. We get to know them better each and every day,” Renfroe said during an award ceremony last Wednesday.”
  • OPM offers a “Readout: OPM Director Kiran Ahuja Visits Houston to Tour NASA Space John Center and Deliver Remarks at the U.S. Customs and Immigration Services Naturalization Ceremony.”  
    • “Director Ahuja delivered remarks at a Naturalization Ceremony at the M.O. Campbell Educational Center. Ahuja welcomed 1,304 new citizens and presented certificates to members of the military and citizens with disabilities.   
      • “In her remarks, Ahuja shared her story and her parent’s journey to the United States, “I can still hear the pride in their voices when they spoke about coming to America and the opportunities this country opened for them. That gratitude led to a sense of purpose – to be engaged citizens; to always vote, because democracy is a gift that so many around the world live without; and to become meaningful part of the communities that we called home.”   
      • “Ahuja encouraged the group of newly naturalized citizens to be empowered by their diverse background and experiences, saying that “now that you’re here, know that you are every bit as important to America as America is to you. You are the future of this country – you will carry on the rich history of a nation made vibrant by the contributions of immigrant communities.”  
      • “Ahuja shared a note for those as new citizens looking to serve their communities and make an impact – stating, “there’s no better place to make a difference than the federal government.  We have influence in every sector and every corner of the country. Whatever your dream job is, there’s a version of it with the federal government. And no matter where you live, there are federal opportunities right there in your community.” 
  • Medscape calls attention to red flags to quicken ovarian cancer diagnosis.

From the public health and medical research front,

  • ABC News reports,
    • “Mpox, formerly known as monkeypox, cases are on the rise here in the U.S., with nearly double the number of infections compared to the same time last year, according to Centers for Disease Control and Prevention data.
    • “While the magnitude of the outbreak experienced in 2022 – where national cases topped 32,000 – is largely over, some high-risk groups need to continue taking precautions, experts say.
    • “Most of the cases that we’re seeing reported are either unvaccinated or under-vaccinated, meaning they either never received a vaccine, or they only got one dose,” Dr. Jenni McQuiston, deputy director of the CDC’s high consequence pathogens and pathology division told ABC News.
    • “The Jynneos vaccine comes in two doses and is recommended for those who have been exposed to someone with mpox as well as those who had a sex partner in the past 2 weeks who was infected. There are currently no recommendations for a booster. Locations offering the free vaccine can be found on the CDC website.
    • “Others eligible for the shot are those who identify as gay, bisexual, or a man who has sex with other men who have had more than one sexual partner or been diagnosed with more than one sexually transmitted disease in the past six months. Those with immune-compromising conditions, such as HIV, are also eligible.”
  • The American Medical Association tells us what doctors wish their patient knew about the contagious norovirus.
  • The Hill informs us,
    • “Sexually transmitted disease rates are rising among adults 55 years old and older, according to data from the Center for Disease Control and Prevention (CDC).
    • “Cases of gonorrhea have grown roughly sevenfold since 2010 among American adults older than 55, per the data.
    • “Meanwhile, the CDC numbers also show cases of chlamydia have more than quadrupled since 2010 among the same age group and syphilis cases in 2022 were nearly eight times higher.  
    • “Some researchers think STD rates are climbing in this age group because older adults are having more sex than in years past, according to reporting from The Washington Post. 
    • “On top of this, older adults rarely use protection, which increases the odds of spreading disease, according to a 2023 study published in peer-reviewed medical journal The Lancet. 
    • “This generation rarely considers using protection because they came of age at a time when sex education in school did not exist, HIV was virtually unheard of, and their main concern in seeking protection was to avoid pregnancy,” Janie Steckenrider, associate professor of political science at Loyola Marymount University and lead author of the study, writes.”
  • The Wall Street Journal reports,
    • “A person in Texas tested positive for avian influenza after exposure to dairy cattle presumed to be infected with the H5N1 bird flu, the Centers for Disease Control and Prevention said Monday. 
    • “The case marks the second known instance that a person in the U.S. has been infected with H5N1 bird flu. The person reported eye redness, or conjunctivitis, as their only symptom and is being treated with an antiviral drug. The human health risk of the bird flu remains low for the U.S. general public, the CDC said, but people with close, prolonged exposures to infected animals or their environments are at higher risk. 
    • “At this point, there’s nothing that suggests that there is any serious risk of a larger human outbreak,” said Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security. “I’m trying to understand why the cows are getting infected. That’s a really important scientific question right now.”
  • Health Day lets us know,
    • “U.S. rates of suicide by all methods rose steadily for adolescents between 1999 and 2020, a new analysis shows.
    • “During those two decades, over 47,000 Americans between the ages 10 and 19 lost their lives to suicide, the report found, and there have been sharp increases year by year. 
    • “Girls and minority adolescents have charted especially steep increases in suicides, said a team led by Cameron Ormiston, of the U.S. National Institute on Minority Health and Health Disparities.
    • “An overall increasing trend was observed across all demographics,” the researchers wrote in a study published March 29 in the journal JAMA Network Open.”
  • and
    • “There are sociodemographic disparities in human papillomavirus (HPV) vaccine uptake among 27- to 45-year-olds, according to a study published online March 28 in Human Vaccines & Immunotherapeutics.
    • “Natalie L. Rincon, from Duke University in Durham, North Carolina, and colleagues explored any sociodemographic disparities in HPV vaccine uptake among 27- to 45-year-olds using data from the 2019 National Health Interview Survey (9,440 participants).
    • “The researchers found that women had more than three times greater odds of vaccine uptake versus men (adjusted odds ratio [aOR], 3.58). Non-Hispanic Blacks were more likely (aOR, 1.36) and Hispanics were less likely (aOR, 0.73) to receive the vaccine, compared with non-Hispanic Whites. Lower odds of uptake were seen among individuals without a usual place of care (aOR, 0.72) and in those with lower educational levels (highs school: aOR, 0.62; some college: aOR, 0.83).
    • “Males are in particular need of increased knowledge of the vaccine. For oropharyngeal cancer, about 75 percent of new cases are in males,” lead author Nosayaba Osazuwa-Peters, M.D., also of Duke University, said in a statement. “As oral HPV is the primary cause of HPV-associated oropharyngeal cancer, providing the HPV vaccine to middle-aged individuals is undoubtedly an important strategy to decreasing risk of infection, persistence, and eventual HPV-associated oropharyngeal malignancy.”
  • MedPage Today notes,
    • “Dropping pack-years for lung cancer screening eligibility in favor of a simpler 20-year history of smoking could substantially increase the number of cancers detected and eliminate racial disparities as well, according to an analysis of smokers from two large cohort studies.
    • “Under current screening criteria from the U.S. Preventive Services Task Force (USPSTF), which call for a 20-pack-year history of smoking, researchers found that 58% of Black patients with lung cancer in the Southern Community Cohort Study (SCCS) would have been eligible for screening, compared with 74% of white patients with lung cancer in SCCS.
    • “But these percentages would increase to 85.3% and 82%, respectively, with the proposed 20-year duration of smoking criteria, “thus eliminating the racial disparity in screening eligibility,” reported Chi-Fu Jeffrey Yang, MD, of Massachusetts General Hospital in Boston, and colleagues in the Journal of Clinical Oncologyopens in a new tab or window.
    • “Additionally, an analysis of the Black Women’s Health Study (BWHS) showed a switch to the simpler requirement would have increased the percentage of Black women who qualified for screening from 43% to 64%.”
  • The Wall Street Journal relates,
    • “Behind the blockbuster success of drugs like Ozempic and Wegovy is a less-noticed phenomenon: Some people don’t lose much weight on them.
    • “There is wide variation in weight loss on these types of drugs, called GLP-1s. Doctors say roughly 10% to 15% of people who try them are “non-responders,” typically defined as those who lose less than 5% of their body weight. These patients, doctors say, don’t experience enough appetite reduction to result in significant weight loss.
    • “Researchers are studying why some people drop a lot of weight on them while others lose little. The answers might yield broader clues about weight loss and provide more insight into these medications, which have transformed the way Americans lose weight.
    • “Doctors believe some people might be resistant to the drugs as a result of genetic differences. Other possible reasons could include certain medical conditions and medications, how much weight a person lost before taking the drugs, and differences in how people metabolize them.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — fell by 2.8% in last year’s fourth quarter, the largest decline ever measured by SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends.
    • “A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis. Over the past year, nine biosimilar versions of the medicine were launched by other companies seeking favorable placement on formularies, the lists of drugs for which health insurance coverage is available.
    • “As these companies battled to win placement, the Humira net price fell to roughly $29,800 at the end of last year from $48,000 at the end of 2022, a nearly 38% drop, the SSR analysis found. In fact, the entire category of rheumatoid arthritis medicines saw a 30% decline in annual net pricing, the largest such drop among all type of drugs. Meanwhile, net prices for psoriasis treatments fell nearly 10%. * * *
    • There were net price gains in two categories, however, which helped offset the declines elsewhere at the end of 2023. Notably, there was a 15.4% net price increase for GLP-1 medicines, which are used to treat diabetes and obesity. This group includes Wegovy and Ozempic, which are sold by Novo Nordisk, and Mounjaro and Zepbound, which are sold by Eli Lilly.
  • Beckers Hospital Review points out ten drugs now in shortage in the U.S.
  • The Wall Street Journal reports,
    • “Mental-health urgent-care sites are proliferating across the U.S. to treat the spiraling numbers of children and adults who need mental-health care and ease a shortage of therapists that has caused many people to wait months for appointments or go to the nearest emergency room to find help.
    • “The sites are starting to change the face of mental-health treatment, offering a much-needed alternative to emergency departments—long the first point of contact for people in mental-health straits—that have become strained by an increase in visits during the pandemic. 
    • “More than 20 mental-health urgent-care centers have opened in the past year alone from Colorado to Virginia. A letter published in the journal Psychiatric Services in 2021 identified 77 of the clinics across the U.S.”
    • “The sites can provide therapy and prescribe drugs or refer patients to a higher level of care if needed, said Katherine Du, a University of Pittsburgh School of Medicine student who was lead author on the letter. Some are run by hospitals, while others were established by private-equity firms. Many are in wealthy areas, but most accept Medicaid. 
    • “We want to get upstream to prevent the crisis,” said Dr. Aliya Jones, executive medical director of behavioral health at the Luminis Health Behavioral Health Urgent Walk-In Clinic in Lanham, Md., which opened in August 2022 and serves ages 4 and older.”
  • BioPharma Dive notes,
    • “The Food and Drug Administration has approved a first-of-its-kind drug for people with the rare and serious blood disease paroxysmal nocturnal hemoglobinuria, or PNH.
    • “Called Voydeya and owned by AstraZeneca, the drug is cleared for use as an add-on therapy to the standard PNH treatments, Ultomiris and Soliris, the pharmaceutical company already sells. It’s meant for the estimated 10% to 20% of people with PNH who still experience significant “hemolysis,” or premature destruction of red blood cells, despite treatment with those other drugs.
    • “The approval builds up a business AstraZeneca inherited when it bought Alexion Pharmaceutical for $39 billion in 2020. That deal established AstraZeneca as a player in rare disease research due to Ultomiris and Soliris, which are each approved for PNH as well as other conditions. The two drugs are among AstraZeneca’s top-selling products, generating more than $6 billion in combined sales in 2023.
    • “Alexion also had drugs in its pipeline, such as Voydeya, that were meant to defend against rising competition from companies like Novartis, Roche and Amgen. The company had acquired Voydeya, previously known as danicopan, when it bought Achillion Pharmaceuticals for nearly $1 billion in 2019.”

Monday Roundup

David Ermer–Cybersecurity, Federal employment benefits, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • STAT News reminds us,
    • “The public will soon find out whether the federal government is willing to meet the health insurance industry’s demands and deposit more money into the bank accounts of next year’s Medicare Advantage plans.
    • “Budget officials within the Biden administration started reviewing final payment regulations for 2025 Medicare Advantage plans last week after more than 42,000 public comments rolled into the federal government’s inbox. Those rules will come out no later than April 1.
  • Becker’s Hospital CFO Report adds,
    • “Onerous” authorization requirements and high denial rates have health systems considering whether to drop Medicare Advantage plans, according to a report from the Healthcare Financial Management Association and Eliciting Insights. 
    • “HFMA Health System CFO Pain Points Study 2024” is based on a survey of 135 health system CFOs conducted in January. 
    • According to the report, 16% of health systems are planning to stop accepting one or more Medicare Advantage plans in the next two years. Another 45% said they are considering the same but have not made a final decision.
    • Health systems have been increasingly pushing back on Medicare Advantage. Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s last year that “it’s becoming a game of delay, deny and not pay.” Scripps terminated Medicare Advantage contracts effective Jan. 1 for its integrated medical groups. The medical groups, Scripps Clinic and Scripps Coastal, employ more than 1,000 physicians, including advanced practitioners. Mr. Van Gorder said the health system was facing an annual loss of $75 million on MA contracts.  
    • “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed,” he said.
    • Despite tensions with some health systems, the Medicare Advantage program had a 95% quality satisfaction rating among enrolled members in 2023.
  • The FEHBlog notes that MA plans are subject to the Affordable Care Act’s medical loss ratio. The medical loss ration encourages health plans to make payments to providers.
  • FedSmith lets us know,
    • The Federal Salary Council (FSC) recently proposed adding about 15,000 federal employees to existing locality pay areas for 2025 from the “Rest of the U.S.” Being added to a locality pay area usually results in higher pay for impacted employees.
    • FSC is recommending the Pay Agent add Wyandot County, OH, to the Columbus, OH, locality pay area and Yuma County, AZ, to the Phoenix, AZ, locality pay area. These recommendations do not create new locality pay areas. In this case, they are adding employees to existing pay areas using various techniques to reduce employees in the “Rest of the U.S.” and add more to higher-paying locality pay areas.
    • A proposal from the Federal Salary Council does not mean a decision to make these additions is finalized. The recommendations have to be approved by the President’s Pay Agent. That approval usually follows, although not necessarily in the recommended time frame. Once the Pay Agent decides to move ahead, the Office of Personnel Management has to issue a proposed change in the Federal Register and a final decision in the Federal Register a few months later.
  • Reg Jones, writing in Fedweek, discusses “Survivor Annuity Benefits for Children of Deceased Federal Employees and Retirees.”
  • KFF discusses Medicare spending on GLP-1 drugs, like Ozempic, to treat diabetes.
    • “Gross spending on Ozempic alone increased from $2.6 billion in 2021 to $4.6 billion in 2022, pushing it to 6th place among the top-selling drugs in Medicare Part D that year, up from 10th place the year before.  
    • “The fact that covering GLP-1s under Medicare Part D for authorized uses is already making a mark on total Part D program spending could be a sign of even higher spending to come as Part D plans are now able to cover Wegovy for its heart health benefits, and if new uses for GLP-1s are approved.”
  • CNBC adds,
    • “Americans can’t seem to get enough of weight loss drugs despite their limited insurance coverage and roughly $1,000 monthly price tags before discounts. 
    • “But some patients are willing to pay more out of pocket for those treatments than others — and it’s strongly correlated to their annual income.
    • “That’s according to a recent survey from Evercore ISI that focused on GLP-1s, which include Novo Nordisk’s weight loss injection Wegovy and diabetes counterpart Ozempic.

From the public health and medical research front,

  • The American Medical Association advises its members about measles, now at 64 cases, and tells patient what doctors wish they knew about vasectomies.
  • Medscape shares five things to know about Adult Respiratory Syncytial Virus (RSV) Infection.
  • The Washington Post features a Consumer Reports article on maintaining kidney health. “Hydration and exercise are just two of the keys to reducing the risk of kidney disease.”
  • The Society for Human Resource Management offers nine mental health questions for employee engagement surveys.
  • CNN reports,
    • “Drugmaker Eli Lilly warned this week that two of its formulations of insulin would be temporarily out of stock through the beginning of April, citing a “brief delay in manufacturing.”
    • “The 10-milliliter vials of Humalog and insulin lispro injection will be in short supply at wholesalers and some pharmacies, Lilly said in a statement posted online Wednesday [March 20]. The company said that prefilled pen versions of those medicines are still available in the US and that it continues to manufacture the 10-milliliter vials “and will ship them as soon as we can.”

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “Hospitals are adding billions of dollars in facility fees to medical bills for routine care in outpatient centers they own. Once an annoyance, the fees are now pervasive, and in some places they are becoming nearly impossible to avoid, data compiled for The Wall Street Journal show. The fees are spreading as hospitals press on with acquisitions, snapping up medical groups and tacking on the additional charges. 
    • “The fees raise prices by hundreds of dollars for widely used and standard medical care, including colonoscopies, mammograms and heart screening. 
    •  “Hospitals say facility fees help offset the extra costs that they incur to meet federal regulations. “It’s not as simple as same services, across-the-board,” said Jason Kleinman, director of federal relations for the American Hospital Association.” * * *
    • “Lawmakers and Congress have proposed limiting fees covered by Medicare, which advisers to the federal insurer have unanimously recommended. Under a bill passed by the House in December, Medicare would no longer pay hospital facility fees for chemotherapy and other drugs infused by doctors in clinics off a hospital campus, saving about $3.7 billion over 10 years. 
    • “The American Hospital Association opposes limiting the fees, saying restrictions would cut revenue to hospitals already squeezed financially by high labor costs and inflation.”   
  • Beckers Hospital CFO Report adds,
    • “Kaufman Hall’s latest “National Hospital Flash Report,” which is based on data from more than 1,300 hospitals, outlined three key areas that separate high-performing hospitals’ and low-performing hospitals when it comes to their operating performances: 
      • “Outpatient revenue. In general, hospitals with higher and accelerating outpatient revenue are more profitable.
      • “Contract labor. Hospitals that quickly reduced their percentage of contract labor demonstrate improved operating profitability. In addition, hospitals that aggressively marched down contract labor costs were correlated to rising wage rates for full-time staff. Rising wage rates appeared to attract and retain full-time staff, which has allowed those hospitals to decrease contract labor more quickly, all of which has led to increased profitability, according to the report. 
      • “Average length of stay. A lower average length of stay corresponded with improved profitability. Hospitals that hyper-focused on patient throughput — which has led to appropriate and prompt patient discharge — have also proven this to be a solid financial strategy, according to the report.”
    • “Hospitals on the other end of the scale continue to struggle, with the poorest financially performing hospitals reporting negative margins from -4% to -19%, according to Kaufman Hall. Continuation of this level of performance is unsustainable and makes it impossible to reinvestment in community care.” 
  • Per BioPharma Dive,
    • “Novo Nordisk will pay as much as $1 billion to acquire RNA drug developer Cardior and its experimental treatment for heart failure, the companies announced Monday. 
    • “Cardior’s treatment, dubbed CDR132L, is currently being tested in a mid-stage study involving 280 people with heart failure who previously experienced a heart attack. Results are expected by September, according to a U.S. clinical trial database.
    • “In addition to that study, Novo said it plans to start another Phase 2 trial in heart failure patients whose heart muscle has become thick and stiff, also known as cardiac hypertrophy. Novo, which will pay an undisclosed upfront payment to Cardior per deal terms, expects the acquisition to close in the second quarter.”
  • and
    • “Abbvie is expanding its pipeline of inflammatory disease drugs, announcing Monday a small deal to acquire biotechnology company Landos Biopharma.
    • “Per the deal, Abbvie will buy Landos for $20.42 per share, or about $138 million. Abbvie has also agreed to pay a so-called contingent value right worth $11.14 per share, or another $75 million, if certain milestones are met. The upfront price represents a premium of about 155% to the closing price Friday of Landos stock.
    • “Landos is currently running a mid-stage trial of its lead drug, dubbed NX-13, in ulcerative colitis. Abbvie is also interested in NX-13’s potential in Crohn’s disease.”
  • Per Healthcare Dive,
    • “Change Healthcare said its largest claims clearinghouses would come back online over the weekend, more than a month after a cyberattack at the technology firm disrupted the healthcare sector. 
    • “More than $14 billion in charges have been prepared for processing, according to an update from parent company UnitedHealth Group on Friday. Change’s electronic payments platform has also been restored, and the company is working on payer implementations.”

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec tells us,
    • “The Senate approved a $1.2 trillion spending package early Saturday shortly after a portion of the government was set to shut down, staving off the threat for the remainder of fiscal 2024. 
    • “The upper chamber moved to approve the measure after funding had lapsed, though shutdown procedures never commenced because an agreement was imminent. President Biden’s was expected to quickly sign the measure, which the House passed on Friday. The spending bill includes funding for the remaining parts of government that have not yet received full-year appropriations, including the departments of Defense, Treasury, Homeland Security, Labor, Health and Human Services, Education and State. 
  • Federal News Network notes,
    • “Congress is looking for details on federal telework as part of the latest government spending agreement — echoing months of return-to-office scrutiny from the House Oversight and Accountability committee.
    • “Among its many provisions, the agreement congressional appropriators reached Thursday for the back half of fiscal 2024 government spending bills lays out six new requirements on federal telework and return-to-office for federal employees.
    • “Within 90 days of the legislation’s enactment, the Office of Management and Budget will have to turn over all agencies’ return-to-office “action plans” outlined earlier this year, lawmakers said in an explanatory statement for the 2024 Financial Services and General Government bill.”
  • The House of Representatives and the Senate are on a two week long break. For those who are interested in an inside baseball approach, the Wall Street Journal examines the coalition government operating in the House of Representatives. Of course, the Democrats have a narrow majority in the Senate. All of that may change as a result of November’s national election.
  • OPM’s FEHB carrier conference will be held on Wednesday and Thursday this week.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Catherine, Princess of Wales, who Friday announced a cancer diagnosis, said she is getting preventative chemotherapy—a treatment that is given after surgery in hopes that it will increase the odds of a cure. 
    • “That the princess is undergoing preventative chemotherapy “suggests to me this is a curable cancer,” said Dr. Angela Jain, an assistant professor in the department of hematology and oncology at Fox Chase Cancer Center in Philadelphia. Jain and other doctors who spoke with The Wall Street Journal aren’t involved in Catherine’s care.
    • “Such chemotherapy, which oncologists call “adjuvant” therapy, is routinely given after surgical removal of a tumor for several months or for as long as a year, Jain said. Patients often get the treatment every two or three weeks. It doesn’t always stop the cancer from returning, but it can increase the odds of eliminating the disease.
    • “Not all cancers need chemo after surgery, but some do,” she said. “And usually you give that treatment with the hope and intention that this is a curable cancer, and chemo will reduce the risk of it coming back.” 
  • The Washington Post adds,
    • “In a recent panel at SXSW in Austin earlier this month, [Katie] Couric spoke about the rise in colorectal cancer. In particular, she hopes women better understand their risks. The risk of developing colorectal cancer is 1 in 23 for men and 1 in 25 for women, according to the American Cancer Society.  
    • “Women, especially younger women, believe this is an old man’s disease, and that’s simply not true,” she says. “Women are diagnosed with colorectal cancer as often as men. I think sometimes people get colons and prostates confused.”
    • “Less than half—44%—of Gen X women have gotten screened for colon cancer, and yet, “they are right in the sweet spot,” Couric says. And 43% of young women believe colon cancer is a men’s disease, of which nearly half think men are impacted two to three times as much as women, which is not correct, according to Medtronic, a health care technology company implementing AI in screening protocols.”  
  • and
    • “The Cancer Detectives,” a new American Experience documentary on PBS, tracks the fascinating and surprisingly frustrating backstory of the Pap smear, a cervical cancer screening test that’s now routine but was once anything but.
    • “The film takes viewers back to the days before Pap smears, a time when cervical cancer was rightfully feared by patients and doctors alike. A century ago, cervical cancer was a major killer of women. Early detection was impossible, and sexual stigma and shame kept women from discussing it.
    • “So it’s not surprising that when an immigrant physician from Greece, George Papanicolaou, nicknamed “Dr. Pap,” discovered a way to detect changes in cervical cells, his breakthrough was largely disregarded by the scientific community.
    • “It would take a massive public relations war against the unspeakable cancer to make the Pap smear a routine part of cervical cancer screening — a war waged in part by Black OB/GYN Helen Dickens, Japanese American illustrator Hashime Murayama and a group of women committed to cancer prevention.”
  • Fortune Well offers tips on how to stay in shape in your thirties, forties, and fifties. Gook luck.
  • The New York Times informs us,
    • “Most people, study after study shows, don’t take the medicines prescribed for them. It doesn’t matter what they are — statins, high blood pressure drugs, drugs to lower blood sugar, asthma drugs. Either patients never start taking them, or they stop.
    • “It’s a problem that doctors call nonadherence — the common human tendency to resist medical treatment — and it leads to countless deaths and billions of dollars of preventable medical costs each year.
    • “But that resistance may be overcome by the blockbuster obesity drugs Wegovy and Zepbound, which have astounded the world with the way they help people lose weight and keep it off. Though it’s still early days, and there is a paucity of data on compliance with the new drugs, doctors say they are noticing another astounding effect: Patients seem to take them faithfully, week in and week out.”
  • Per mHealth Intelligence,
    • “Using telehealth to provide palliative care support to rural family caregivers is a low-cost and feasible strategy for transitioning patients from hospital to home-based care, new research reveals.
    • “Conducted by researchers from the Mayo Clinic, Duke University, and the Minneapolis Veterans Affairs Health Care System, the study examines a telehealth-based palliative care support program for rural family caregivers who face challenges in accessing coordinated care for their loved ones during and after hospitalization. It also evaluated resource use, health system costs, and Medicare reimbursement pathways for this approach. Results were published in the American Journal of Hospice and Palliative Medicine.”
  • The MIT Technology News points out,
    • “Alex Zhavoronkov has been messing around with artificial intelligence for more than a decade. In 2016, the programmer and physicist was using AI to rank people by looks and sort through pictures of cats.
    • “Now he says his company, Insilico Medicine, has created the first “true AI drug” that’s advanced to a test of whether it can cure a fatal lung condition in humans. 
    • “Zhavoronkov says his drug is special because AI software not only helped decide what target inside a cell to interact with, but also what the drug’s chemical structure should be.”
  • From the Wall Street Journal,
    • “Elon Musk’s Neuralink introduced the first patient to receive its brain-computer implant, a 29-year-old diving-accident victim who showed during a livestream that he can now move a computer cursor using the device.
    • “In a nine-minute presentation streamed on Musk’s X platform Wednesday, Neuralink showed Noland Arbaugh directing the cursor around a screen to play a game of chess. Arbaugh said it feels like “using the force on a cursor,” referring to a concept from movies such as “Star Wars.” He said his surgery went well and he left the hospital after one day.
    • “Moving a computer cursor isn’t a big technical leap for brain-computer interfaces. An older brain chip first implanted in a human in 2004 also helped a paralyzed person move a cursor with only their thoughts. But the older chip must be attached to a device on the outside of the brain to transmit data, requiring wires protruding through the skin.
    • “Neuralink’s device transmits data wirelessly, and it can be used at home, outside of a laboratory setting.
    • “Another notable feature of Neuralink’s presentation was that Arbaugh was multitasking: playing chess while speaking about his experience getting the implant. Prior demonstrations of brain-computer interfaces have required dedicated attention to a particular task.”
  • and
    • “The more time you spend alone, the more likely you are to be lonely, right?
    • “Seems obvious. But it isn’t always true, according to a new study. For instance, it found that although, in general, those who spend the most time alone are the loneliest, that isn’t the case for young people; their time alone has little impact on how lonely they feel. What’s more, people who spend the least time alone tend to be slightly lonelier than those between the extremes. * * *
    • “Relationship status also was significant. Single people tended to spend more time alone than those in relationships and reported greater loneliness. Gender wasn’t a significant predictor of loneliness, the study found.
    • “The bottom line is that loneliness can’t simply be measured by the degree of a person’s social interaction.
    • “The degree of loneliness a person experiences is influenced by how much social interactions they have and by how much social interactions they feel they need,” Mehl says. “Beyond that, an important determinant of feelings of loneliness is the perceived meaning that a person derives from the social interactions they have.”