Midweek Update

OPM

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.”

Weekend Update

David Ermer–Congress, OPM, U.S. Healthcare–

From Washington, DC,

  • The Government Accountability Office posted a report on public health preparedness.
    • “Health and Human Services was initially charged with coordinating the federal response to a 2022 global outbreak of mpox—a smallpox-related virus.
    • “State and local jurisdictions cited challenges in the federal response such as difficulty accessing and using vaccines and tests, which may have led to unnecessary suffering. We added HHS’s leadership and coordination of public health emergencies to our High Risk List earlier in 2022 due to similar issues in past responses.
    • “We recommended that HHS adopt a coordinated, department-wide program that incorporates input from external stakeholders to identify and resolve challenges.”
  • FedSmith offers its take on OPM’s benefit administration letter about tightening FEHB eligibility oversight.
    • “OPM will use its newly completed FEHB Master Enrollment Index (MEI) to run queries that can spot certain enrollment irregularities in existing enrollments. If any are found that raise questions, OPM will notify agencies to review those enrollments.”
    • In the FEHBlog’s view, the Master Enrollment Index will not be reliable until OPM starts using the HIPAA 820 electronic enrollment roster transaction which will allow carriers to reconcile individual enrollments with premiums received.

From the public health and medical research front,

  • The Washington Post reports on ongoing efforts to create a global pandemic preparedness accord.
    • “The United States has signaled its support for a legally binding agreement, including leveraging its purchasing power to expand access to medicines around the world. But the United States, like many European Union countries, is the object of mistrust because it is the seat of the powerful pharmaceutical industry, which is reluctant to relax control over manufacturing know-how.”
  • Fortune Well discusses how to keep your water bottle clean.
    • “Like many people, Carl Behnke regularly totes a water bottle around throughout his day. From the office to the gym and back home again, Behnke is rarely without it. But Behnke is also an associate professor in the school of hospitality and tourism management at Purdue University, and when he discovered a “biofilm” on the inside of his water bottle while cleaning it, it got his wheels turning. “I realized I probably wasn’t as diligent about cleaning my water bottle as I should be,” he explains. “And that made me curious: if someone who knows about food safety isn’t diligent, what about everyone else?”
    • “That question led to a study, conducted by Behnke and a cohort of academics and scientists into how reusable bottle contamination levels are affected by usage and cleaning behaviors. The group set about to measure contamination levels of water bottles, and to understand how those levels are affected by usage and cleaning behaviors. If you’re regularly drinking water from a reusable bottle, their findings might prompt you to reconsider your own water bottle handling practices.  * * *
    • “Dr. Yuriko Fukuta, assistant professor of medicine—infectious diseases at Baylor College of Medicine, agrees. “We’re constantly touching our water bottles with our mouths and hands, so it’s easy to transmit bacteria to them, and then it just grows,” she says “In some cases, this can make you sick, especially if you have a weaker immune system.” * * *
    • According to Fukuta, your best bets are bottles with a wide mouth, which make them easy to clean and dry, those with a built-in straw that keeps your hands away if possible.
    • If your goal is to keep your water bottle from turning into a germy breeding ground, the simplest approach is Behnke’s, which he changed after conducting the research. “I rinse my bottle once a day,” he says, “and wash it once a week, using good detergent, a bottle brush, and a spray of Clorox bleach.”

Midweek Update

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Federal Times and Federal News Network discuss OPM’s plans to tighten internal controls over family member eligibility in the FEHBP. OPM’s actions will shift the burden of monitoring family member eligibility from the FEHB plans to employing agencies, which is where the responsibility belongs.
  • OPM also should be filling the greatest internal control gap in the FEHB – the fact that OPM does not allow carriers, which bear the insurance risk, to reconcile premium payments to individual enrollees. A cost effective solution is available by implementing the HIPAA 820 electronic enrollment roster transaction which systematically generates such reconciliations.
  • Per BioPharma Dive,
    • “Alvotech and Teva on Tuesday won Food and Drug Administration approval for Selarsdi, the second biosimilar poised to challenge Johnson & Johnson’s blockbuster psoriasis drug, Stelara.
    • “The FDA cleared Selarsdi for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children who are at least 6 years old. The companies said they expect to begin selling the medicine on or after Feb. 21, 2025, a delayed introduction due to a legal settlement with J&J.
    • “The two companies are likely to enter the market after Amgen, which won approval for an interchangeable biosimilar called Wezlana in October. Amgen is also subject to a legal settlement, and the company has said its product will launch no later than Jan. 1, 2025.”
  • Healthcare Dive had the time to report on the CBO report on Medicare Accountable Care Organizations which the FEHBlog noted yesterday.
    • “Accountable care organizations led by independent physicians save Medicare more money than other types of ACOs, according to a new Congressional Budget Office review of existing research.
    • “Independent physician-led ACOs have clear financial incentives to reduce hospital care to lower spending, while hospital-led ACOs — which earn more revenue when patients are admitted — do not, the CBO found. Hospitals also have less direct control over what services patients receive.
    • “ACOs with a larger proportion of primary care providers also saved Medicare more money, along with ACOs whose initial spending was higher than their peers in the same region, according to the report.”
  • The FEHBlog’s primary care provider practices in such an ACO.

From the public health and medical research front,

  • The New York Times reports,
    • “A pill taken once a week. A shot administered at home once a month. Even a jab given at a clinic every six months.
    • “In the next five to 10 years, these options may be available to prevent or treat H.I.V. Instead of drugs that must be taken daily, scientists are closing in on longer-acting alternatives — perhaps even a future in which H.I.V. may require attention just twice a year, inconceivable in the darkest decades of the epidemic.
    • “This period is the next wave of innovation, newer products meeting the needs of people, particularly in prevention, in ways that we didn’t ever have before,” said Mitchell Warren, executive director of the H.I.V. prevention organization AVAC.
    • “Long-acting therapies may obviate the need to remember to take a daily pill to prevent or treat H.I.V. And for some patients, the new drugs may ease the stigma of the disease, itself an obstacle to treatment.”
  • STAT News lets us know,
    • “Eli Lilly reported positive results for its obesity drug Zepbound in obstructive sleep apnea, giving the medication a new edge in the highly competitive obesity market.
    • “The results also pave the way for Zepbound to potentially become the first approved treatment for obstructive sleep apnea, or OSA, a common disorder characterized by breathing interruptions during sleep.
    • “In one year-long Phase 3 study that looked at patients with obesity who were not on PAP therapy, a form of ventilation, those taking Zepbound experienced a reduction of 25.3 events per hour on the apnea-hypopnea index (AHI), a measure of the number of times breathing stops and becomes restricted while sleeping. That compares with a reduction of 5.3 events in patients on placebo, Lilly said in a press release Wednesday.
    • “In another Phase 3 study in patients who were on PAP therapy, those on Zepbound had a reduction of 29.3 events per hour on the AHI, compared with a reduction of 5.5 events in patients on placebo.
    • “Severe OSA is defined as having over 30 events per hour, and moderate OSA is defined as 15 to 30 events per hour.”
  • CNBC adds,
    • “Most doses of Eli Lilly’s highly popular weight loss drug Zepbound and diabetes counterpart Mounjaro will be in short supply through the second quarter of this year due to increased demand, according to an update on the Food and Drug Administration’s drug shortage database.
    • “A previous update said some doses of both treatments would have limited availability through April.
    • “The new update suggests that the insatiable demand for a buzzy class of weight loss and diabetes drugs is still trouncing supply, even as Eli Lilly and Novo Nordisk work to increase production of those treatments.” 
  • The Associated Press informs us,
    • “For decades, patients seeking medication for pain have had two choices: over-the-counter drugs like aspirin or powerful prescription opioids like oxycodone.
    • “Opioid prescriptions have plummeted over the last decade as doctors have become more attuned to the risks of addiction and misuse during the country’s ongoing drug epidemic.
    • “Vertex Pharmaceuticals recently reported positive results for a non-opioid painkiller, one of several medications the Boston-based drugmaker has been developing for various forms of pain. Patients taking the drug after surgery experienced more pain relief than those getting a placebo, although the drug didn’t meet a secondary goal of outperforming treatment with an opioid.
    • The AP interviews Vertex’s chief scientist Dr. David Altshuler about the company’s research and development plans.
  • Beckers Hospital Review tells us,
    • “In recent months, parts of the U.S. have reported outbreaks of pertussis, or whooping cough. While some regional outbreaks are expected each year, health officials are underscoring the importance of boosters in adults to protect infants from severe illness, NBC News reported April 17.  * * *
    • “The TDap vaccine is recommended for children 11 and older who have not received the DTaP series. Adults should receive a Tdap booster dose every 10 years, according to the CDC. 
    • “Anyone who comes to see [a] new baby should have had a recent inoculation with Tdap vaccine to provide a cocoon of protection around that baby,” William Schaffner, MD, professor of infectious diseases at Nashville, Tenn.-based Vanderbilt University Medical Center, told NBC News.” 

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Steward Health Care is on the clock. 
    • “The Dallas-based healthcare network has until the end of the month to prove to lenders it has the cash on hand to begin repaying its significant debts — or it could face bankruptcy proceedings. 
    • “Demonstrating solvency could be a tall order because the health system owes a lot of parties a significant amount of money, according to analysts familiar with the system. 
    • “Should Steward fail, it would be one of the largest provider bankruptcies in decades, said Laura Coordes, professor of law at the Sandra Day O’Connor College of Law at Arizona State University.” 
  • MedTech Dive notes, “Abbott looks to ‘highly productive’ device pipeline for future growth. CEO Robert Ford highlighted new and upcoming products throughout the earnings call, calling the recently approved Triclip valve a “billion-dollar opportunity.”
  • According to BioPharma Dive,
    • “An experimental drug designed to improve brain function in people with nerve-degrading disorders has failed a mid-stage study that tested it against Parkinson’s disease.
    • “The trial enrolled almost 90 participants, who once a day were given either a placebo or a drug from Sage Therapeutics called SAGE-718. Summary results released Wednesday showed no significant difference between the two groups in how their mental abilities changed over the course of six weeks, as measured by a scale clinicians use evaluate cognition. * * *
    • “Sage is still testing SAGE-718 across three additional trials that should have data this year. One, codenamed “Lightwave,” is focused on people with mild cognitive impairment and mild dementia due to Alzheimer’s disease. The other two, “Surveyor” and “Dimension,” are investigating whether the drug can help Huntington’s disease patients with cognitive impairment.”
  • Beckers Hospital Review points out and names ten of twenty most popular drugs are in shortage.

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.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Generative AI, HSA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Washington Post reports,
    • On Thursday, FDA Commissioner Robert Califf appeared before the panel for the first time this Congress, facing a roughly four-hour grilling on a wide range of issues, from the infant formula crisis to tobacco regulation to an abortion pill. 
    • * * * Of note,
      • “The composition of a highly pathogenic strain of bird flu doesn’t appear to be resistant to current treatments already on the market for the flu, Califf said. This comes after a dairy worker in Texas was recently treated for bird flu, which has been identified in dairy cattle for the first time. 
      • “It’s always the case that when you have an actual illness you have to empirically prove that it works,” Califf said. “Fortunately right now, there’s really only one infected human that we know of, so it’s not something that we can test. But it looks good at this point.”
  • House Budget Committee Health Care Task Force (HCTF) Chair Rep. Michael C. Burgess, M.D. (R-TX) wrote an op-ed in the Hill about how to pay for 21st Century medicine.
    • “Medical advances have opened a new world of hope for patients suffering from serious and life-threatening diseases. We need to match our 21st century science with 21st century payment models and offer patients hope without breaking the budget.
    • “My legislation, the Preventive Health Savings Act, offers another new tool to help Congress identify the long-term savings generated by some of these novel therapies and assist in implementing new payment pathways.
    • “We can keep marching forward and saving lives, or we can turn the clock back. Congress needs to address these challenges by anticipating the future instead of wallowing in the past.”
  • Fierce Healthcare adds,
    • Instead of enacting public option plans, states should target reinsurance programs, a new report from the Partnership for America’s Health Care Future argues.
    • The group includes a collection of health plans, hospital groups and pharma companies brought together largely to oppose Medicare for All. This study was authored by three policy experts with the Hoover Institution at Stanford University.
  • OPM could encourage Congress to create a reinsurance pool for gene therapy treatments within FEHBP and PSHBP using the unused portion of the 1% surcharge on FEHB premiums intended to fund OPM’s FEHB / PSHB administrative costs.
  • Assistant Secretary of Labor for Employee Benefit Security Lisa Gomez wrote in her blog about how to unlock the power of prevention in the fight against cancer.
  • The Washington Post points out,
    • “Covid forced the public health field and health-care sector to work toward a shared goal of keeping people from becoming so ill that they overwhelm hospitals. Now, a group of health-care leaders — the Common Health Coalition, which represents physicians, hospitals and insurers — is trying to build upon these collaborations to better prepare localities for future health threats.”
  • Govexec.com informs us,
    • “The Office of Personnel Management issued a final rule Friday that would cull Social Security numbers from any mailed document in an effort to prevent fraud. 
    • “The rule, which was published in the Federal Register, is part of the implementation of the 2017 Social Security Number Fraud Prevention Act and is designed to help protect the identifiers, which can be used in various forms of identity theft. 
    • “The theft and fraudulent use of SSNs can result in significant repercussions for the SSN holder, as well as the entities from which SSNs were stolen,” OPM officials said in the Federal Register notice. “This direct final rule formalizes in regulation OPM’s current practice of safeguarding SSNs in mailed documents and will support efforts to protect individual privacy.”

From the public health and medical research front,

  • The Centers for Disease Control let us know earlier 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, 1 jurisdiction experienced high activity compared to 6 jurisdictions experiencing high activity the previous week. [The outlier jurisdiction is North Dakota.]  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 Washington Post offers detailed background on prostate cancer following former NIH Director Francis Collins announced that he has the disease.
  • The Wall Street Journal reports,
    • “The European Union’s drug regulator found no link between the class of medicines behind 
    • “Novo Nordisk’s blockbuster Ozempic and Wegovy treatments and reports of suicidal thoughts in patients.
    • “A study by a European Medicines Agency committee had been looking at potential links between the popular weight-loss and diabetes drugs and reports of suicidal and self-harming thoughts from people using them, but it said Friday that the evidence doesn’t support a causal association.
    • “The U.S. Food and Drug Administration came to the same conclusion in January while British health authorities are carrying out their own review.”
  • Today, the FEHBlog heard an OptumRx speaker at a local conference describe the following demographic characteristics of members of employer sponsored plans who use GLP-1 weight loss drugs.
    • 4 out of 5 are women
    • Average age range is 35-54 with a concentration in the 45 to 54 age range.
    • Average BMI is 35. According to the Cleveland Clinic, “Class III obesity, formerly known as morbid obesity, is a complex chronic disease in which a person has a body mass index (BMI) of 40 or higher or a BMI of 35 or higher and is experiencing obesity-related health conditions.”
  • Bear in mind that most employer sponsored plans do not cover retirees while the FEHBP does. The FEHBlog expects that the speaker provided a useful perspective on GLP-1 use among active employees participating the FEHP. KFF remind us the there are plenty of Medicare beneficiaries using GLP-1 drugs for diabetes.
    • In 2022, Medicare gross total spending reached $5.7 billion on Ozempic (semaglutide), Rybelsus (semaglutide), and Mounjaro (tirzepatide), all of which it covered for diabetes that year, according to just-released Medicare drug spending data [before manufacturer rebates]. That was up from $57 million in 2018. 
  • The Optum speaker also remarked that biosimilar competition caused Abbvie to lower the price of its blockbuster Humira drug by 30% in 2023. He explained that it takes time for biosimilars to gain market share when the brand drug drops its price substantially.
  • Per Fierce Healthcare,
    • “Approximately 40,000 women die of breast cancer in the U.S. each year.
    • “One way of reducing that number is ensuring access to preventive screenings such as mammograms. But health-related social needs can have an impact on a woman’s chance of being up to date with her mammogram. For example, women are less likely to get a mammogram if they feel socially isolated, have lost a job or don’t have reliable transportation, according to a recent Centers for Disease Control and Prevention (CDC) Vital Signs report.”
  • The New York Times provides expert opinions on whether artificial intelligence mammograms are worth the cost.
    • “The Food and Drug Administration has authorized roughly two dozen mammography A.I. products. Some of these are being rolled out to patients in a small number of clinics and tested by other hospitals that want to be certain of the value these tools provide before offering them to patients. 
    • “There is currently no billing code that radiologists can use to charge insurance providers for the technology. That means some centers may punt the cost to patients, charging between $40 to $100 out of pocket for an A.I. analysis. Other hospitals may absorb the cost and offer the additional analysis for free. Still others may keep the technology for research until they are more certain of the value it can provide to patients.
    • “It will take some time for A.I. to become part of routine care, which would lead insurance companies to consider reimbursing their cost. Until then, most patients don’t need A.I. for their mammograms, said Dr. Katerina Dodelzon, a radiologist who specializes in breast imaging at NewYork-Presbyterian/Weill Cornell Medical Center, though it might provide some extra reassurance for those who are particularly anxious about their results.”
  • Medscape tells us,
    • “Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.
    • “Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower income countries.
    • “The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. 
    • “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “More than three-fourths of all U.S. doctors are now employed by hospitals, health insurers, private equity or other corporate entities, as rampant consolidation continues to shrink the number of independent physicians, according to new data.
    • “Between 2019 and 2024, more than 44,000 medical practices were acquired, according to the report published Thursday by Avalere Health, commissioned by the Physicians Advocacy Institute. As a result, nearly 60% of medical practices are now owned by corporations.
    • “As of January 2024, physician practice ownership by corporations — including health insurers, pharmacy chains and PE firms — exceeded ownership by hospitals and health systems for the first time, 30.1% to 28.4%. However, hospitals employ more than half of all U.S. physicians, while other corporations employ a little over one-fifth.”
  • MedTech Dive informs us,
    • “Roche has received the Food and Drug Administration’s breakthrough device designation for a blood test to support earlier diagnosis of Alzheimer’s disease, the Swiss drug and diagnostics company said Thursday.
    • “The test, once approved, could help healthcare providers identify whether amyloid pathology, a marker for Alzheimer’s disease, is present or absent in patients.
    • “The Elecsys pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly. * * *
    • “New and emerging Alzheimer’s therapies aimed at slowing cognitive decline in the earlier stages of the disease call for confirmation of amyloid pathology, yet the only methods currently cleared for that task are cerebrospinal fluid (CSF) tests and amyloid positron emission tomography, or PET, scan imaging, according to Roche.”
  • Per BioPharma Dive, while “new postpartum depression drugs are here, diagnosis, treatment hurdles still stand in the way. Two Sage Therapeutics medicines are approved for the condition. But uptake of the first has been minimal, while the launch of the second [which is a pill] is still getting off the ground.”
  • The Employee Benefit Research Institute made available a new paper on high deductible health plans with health savings accounts.
    • “The purpose of this paper is to examine the impact of plan type on use of health care services and spending. The analysis focuses on enrollees in HSA plans and PPO enrollees who are in health plans with deductibles large enough to be HSA eligible as a way of isolating the impact of the HSA on use of health care services.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Medical / Rx research, Medicare, NIH, OPM, Patient safety, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • This morning, the Senate Finance Committee held a hearing to “discuss how to update and strengthen Medicare’s guarantee of high-quality health benefits for the next generation of America’s seniors.”
  • Healthcare Dive informs us,
    • “Lawmakers lauded the benefits of telehealth during a hearing Wednesday, but House members also raised questions about cost, quality and access that still need to be answered as a year-end deadline looms.
    • “As a December deadline draws closer, legislators are working to hash out details about extending or making pandemic-era telehealth flexibilities in Medicare permanent. 
    • “During an hours-long House Energy and Commerce subcommittee hearing, lawmakers considered 15 different legislative proposals surrounding telehelath access, noting changes in Medicare will impact decisions of private insurers.
    • “There’s an urgent need to extend these flexibilities because it’s going to run out,” said Rep. Anna Eshoo, D-Calif. “We need to take action on this.” 
  • STAT News adds,
    • “More than a quarter of outpatient antibiotics are inappropriately prescribed, and telehealth could exacerbate the problem: Studies have suggested that virtual visits, on average, result in more antibiotic prescribing than in-person visits. But not all telehealth is created equal — and research is beginning to untangle which approaches are more likely to result in unnecessary antibiotics. In turn, national telehealth guidelines and standards are fighting back by prioritizing safe and effective virtual prescribing practices.
    • “It’s hard to draw conclusions about antibiotic prescribing via telehealth because it comes in so many flavors, said Guillermo Sanchez, a physician assistant and epidemiologist with the office of antibiotic stewardship at the Centers for Disease Control and Prevention. Telemedicine can be provided by direct-to-consumer companies in one-off visits or by large, integrated health systems; via message, phone, or video.
    • “In a recent literature review, Sanchez and his colleagues found studies showing antibiotics were prescribed similarly in virtual and in-person appointments, as well as research that showed higher prescribing in virtual visits — especially for upper respiratory infections that rarely need antibiotics.
    • “But one thing is clear: There’s plenty of room for improvement.”
  • American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention April 11 updated its strategy to improve data exchange with health care organizations and other public health authorities to better detect and monitor public health threats. Among other priorities for 2024-2025, the strategy calls for using the Office of the National Coordinator for Health Information Technology’s Trusted Exchange Framework and Common Agreement to enable faster sharing of data between health care and public health; expanding core data sources to detect and monitor threats, including wastewater, hospitalization and hospital bed capacity; and prioritizing data to address health disparities and promote health equity.”
  • STAT News reports,
    • “Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer has projected — according to a document obtained by STAT.
    • “Medicare’s actuaries expect the drug Leqembi, made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medicare program $3.5 billion in 2025, a spokesperson for the Centers for Medicare and Medicaid Services confirmed to STAT. That projection forecasts a large increase in uptake over the next year and a half.
    • “The estimate was buried in a new CMS document that addressed questions about next year’s payments for Medicare Advantage plans, which cover more than 33 million people and serve as the alternative to the traditional Medicare program.
    • “I think CMS’ estimates demonstrate an incredible demand for Alzheimer’s treatments and possibly suggest broader use than I think was originally conceived,” said Ameet Sarpatwari, an assistant professor of medicine at Harvard Medical School who studies pharmaceutical costs and outcomes. “That raises the question: What are we, as taxpayers, willing to spend on this drug with limited resources?”
  • The U.S. Office of Personnel Management announced,
    • “The U.S. Office of Personnel Management (OPM) issued a final rule today on the Pathways Programs designed to significantly expand opportunities for early career talent in the federal government. The final rule is one of the most significant actions the federal government has taken since the program’s inception 14 years ago. Updates include expanding skills-based hiring through qualifying career programs, raising the ceiling for starting salaries for recent graduates, and easing the path for interns to be converted into permanent positions, including lowering the number of hours required to convert and expanding the time given to agencies to complete such a conversion.  
    • “In addition, OPM will soon release new web-based guidance, an updated Pathways Program Handbook, an updated Pathways Toolkit for federal managers and supervisors, and will host a series of webinars and office hours targeted at HR professionals, hiring managers, educational institutions, and other key stakeholders.”  

From the public health and medical research front,

  • MedPage Today tells us,
    • “The hunt for a signal of excess sudden cardiac deaths among young people after COVID-19 vaccination left Oregon health officials empty-handed, they reported.
    • “Investigators searched death certificates for Oregon residents 16-30 years old who died from cardiac or undetermined causes of death from June 2021 to December 2022 and tried to match these deaths with mandatory statewide records of mRNA COVID vaccination, according to Juventila Liko, MD, and Paul Cieslak, MD, both of the Oregon Health Authority’s Public Health Division in Portland, in the CDC’s Morbidity and Mortality Weekly Report.”
  • The NIH Director in her blog lets us know,
    • “Colorectal cancer is a leading cause of death from cancer in the United States. We know that risk of colorectal cancer goes up with age, certain coexisting health conditions, family history, smoking, alcohol use, and other factors. Researchers are also trying to learn more about what leads colorectal cancer to grow and spread. Now, findings from a new study supported in part by NIH add to evidence that colorectal tumor growth may be driven by a surprising bad actor: a microbe that’s normally found in the mouth.
    • :The findings, reported in Nature, suggest that a subtype of the bacterium Fusobacterium nucleatum has distinct genetic properties that may allow it to withstand acidic conditions in the stomach, infect colorectal tumors, and potentially drive their growth, which may lead to poorer patient outcomes. The discoveries suggest that the microbe could eventually be used as a target for detecting and treating colorectal cancer.”
  • Beckers Hospital Review points out,
    • “The number of ongoing drug shortages in the U.S. is at its highest since 2001 — when the American Society of Health-System Pharmacists began tracking data. There are now 323 medications in low supply. 
    • “The reasons for 3 in 5 shortages are unknown, the ASHP said in a report released April 11. Supply and demand are cited for 14% of shortages, manufacturing problems for 12%, business decisions for 12% and raw material issues for 2%. 
    • “Basic and life-saving products are in short supply, including oxytocin, Rho(D) immune globulin, standard of care chemotherapy, pain and sedation medications and ADHD [attention-deficit/hyperactivity disorder] medications,” the ASHP said. 
    • “The top five drug classes in shortages are central nervous system agents, antimicrobials, hormone agents, chemotherapies, and fluid and electrolyte therapies.” 
  • Mercer Consulting alerts us,
    • “Are you ready for the 75-year plus workforce? That’s the question Dr. Charlotte Yeh from AARP Services Inc. asked our webcast participants when she sat down with Mercer’s Kate Brown to discuss how longevity is changing workforce demographics.
    • “In the last 100 years, the 65+ age group has grown five times faster than the rest of the population. What’s even more surprising are projections that people aged 75+ will constitute the fastest-growing age band in the civilian workforce between now and 2030! As an employer, are you prepared for these changing demographics?
    • “In this conversation, Dr. Yeh debunks common myths about older workers – including their inability to use technology to perform essential job functions. In fact, studies show that age-diverse workforces contribute to increased revenue and profit margins – perhaps not surprising given that people 50 and older, contribute $8.3 trillion dollars to the economy. At the same time, working later in life can provide seniors with purpose and social connections, both essential to health and happiness.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Hospitals and health systems have kicked off the calendar year with a flurry of merger and acquisition deals reflecting several different strategic trends driving providers in 2024.
    • “Twenty transactions were unveiled in the first quarter, marking the highest volume of dealmaking Kaufman Hall’s seen within the sector since 2020, according to a report from the healthcare consulting firm released Thursday.
    • “The deals involved organizations of varying sizes and types, the firm wrote, and appeared motivated by a combination of new and old health system trends — for instance, smaller community systems flocking to larger organizations with stable finances, or portfolio realignments among for-profit and non-profit systems alike.”
  • According to Beckers Hospital Review,
    • “Less than 20% of the nation’s hospitals were recognized for excellent patient safety ratings and the highest level of adherence to federal price transparency rules. 
    • “On April 9, the Health Transformation Alliance, The Leapfrog Group and Turquoise Health honored 472 hospitals across 42 states. Each of the organizations received a Leapfrog “A” safety rating and the highest price transparency score from Turquoise Health. 
    • “We encourage all hospitals to look to these industry leaders in both patient safety and price transparency as a model for how to provide patient-centered, high-quality care,” Robert Andrews, CEO of Health Transformation Alliance, said in a news release. “In following their example and commitment to safety and price transparency, we believe the healthcare industry can collectively strive towards better health outcomes for all.”

From the legal news front,

  • Biopharma Dive reports,
    • “The U.S. Department of Justice on Wednesday accused Regeneron of defrauding Medicare by knowingly inflating the average sales price for its top-selling eye drug Eylea.
    • “In a lawsuit filed in U.S. District Court in Massachusetts, prosecutors alleged Regeneron failed to disclose hundreds of millions of dollars in price concessions given to drug distributors in the form of credit card fee reimbursements. As a result, they said, the average sales price for Eylea, which Medicare uses to set payment to doctors, was higher than it should have been.
    • “Regeneron’s tactics also gave it an unfair competitive advantage over rivals, the Justice Department said. Eye clinics were able to get Regeneron’s drug for the discounted cash price while at the same time reaping the benefits of credit card rewards such as “cash back.” At some practices, doctors took turns using their personal credit cards to buy the drug, the lawsuit said. * * *
    • “In a statement to BioPharma Dive, Regeneron said it believes the allegations are “without merit” and show a “fundamental misunderstanding of drug price reporting standards.” The company added that it will defend itself in court.” 
  • The U.S. Attorney for the Southern District of Florida announced,
    • “On April 10, a substance abuse facility owner was sentenced to four years in federal prison, followed by three years of supervised release, and ordered to pay $4,444,417.65 in restitution, for defrauding the Federal Employees Health Benefits Program (FEHBP) of over $4 million. The sentence comes after the defendant entered a guilty plea in February.
    • “Joseph Toro, 39, of Jupiter, Florida, owned and operated Reawakenings Wellness Center (RWC), a substance abuse facility that treated patients, including FEHBP beneficiaries, from 2013 until January 2018, when RWC was evicted from their location in Miramar, Florida. After the RWC eviction, Toro continued to submit FEHBP insurance claims, using personal identifying information of former RWC patients, for substance abuse treatment that was never provided. To do so, he called the FEHBP hotline, impersonated former patients, and changed their mailing addresses to addresses that he controlled so he could obtain the fraudulent insurance reimbursement checks. For over a year, Toro submitted fraudulent claims on behalf of 29 former RWC patients for over $6.7 million in substance abuse treatment that he knew RWC never provided. As a result of Toro’s fraudulent claims, he obtained nearly $4.2 million in proceeds from the FEHBP. Toro also applied for and obtained a $150,000 Economic Injury Disaster Loan (EIDL) from the U.S. Small Business Administration (SBA) during the COVID-19 pandemic. That application misrepresented that RWC had five employees and grossed over $1.4 million in 2019, when in truth RWC had shut down years prior.”

Midweek Update

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

From Washington, DC

  • Govexec tells us,
  • “The House Oversight and Accountability Committee on Wednesday advanced legislation [HR 7868] aimed at preventing improper payments in the employer-sponsored health insurance program for federal workers, as well as to ensure roughly 1,200 U.S. Customs and Border Protection officers receive the enhanced retirement benefits they were promised. * * *
  • “Rep. Jamie Raskin, D-Md., the committee’s ranking member, sought unsuccessfully to amend the bill to include language that would authorize additional funding go to OPM to cover the cost of the audit, but Committee Chairman James Comer, R-Ky., expressed a willingness to amend the bill before it reaches the House floor authorizing a specific dollar figure, based on analysis from the Congressional Budget Office. The CBO does not “score” legislation until it has advanced out of committee.”
  • A client of the FEHBlog called to his attention today this April 1, 2024, Centers for Medicare and Medicaid Services (CMS) Part D instruction which calmed the FEHBlog’s nerves about the 2025 notice of creditable coverage which FEHB plans must issue:
    • “Creditable Coverage
    • “Consistent with IRA changes, we are revising the regulatory definition of creditable coverage at § 423.56(b) to reflect that discounts paid under the Manufacturer Discount Program are not taken into account when determining actuarial value. Given various concerns raised by commenters and the significant changes to the Part D benefit for CY 2025 as a result of the redesign, CMS will continue to permit use of the creditable coverage simplified determination methodology, without modification to the existing parameters, for CY 2025 for non-EGWP group health plan sponsors not applying for the retiree drug subsidy under section 1860D-22(a) of the Act. The Final Program Instructions also specify that CMS will re-evaluate the continued use of the existing simplified determination methodology or establish a revised one for CY 2026 in future guidance.”
  • The FEHBlog loves simplicity.  
  • Fierce Healthcare informs us,
    • “The Biden administration is proposing a 2.6% increase for inpatient hospitals’ payments for the coming fiscal year, a $3.3 billion increase over the current year’s payout, as well as other policy adjustments intended to shore up surgical care coordination, drug supply, emergency preparedness monitoring, maternal health and care for the underserved.
    • “The potential updates came under Centers for Medicare & Medicaid Services (CMS)’s proposed Inpatient Prospective Payment Systems (IPPS) rule and the Long-Term Care Hospital pay rule, which were unveiled Wednesday afternoon.
    • “Hospitals that participate in the IPPS Quality Reporting Program and meaningfully use electronic records are projected to get a 2.6% increase to payments for fiscal year 2025, which begins in October. The pay raise is based on a projected hospital market basket update of 3%, which is reduced by a projected 0.4 percentage point productivity adjustment, according to a release on the rule.
    • “Long-term care hospitals are looking at a proposed 2.8% pay increase, which is a 1.6% or $41 million bump over the current year. This is “primarily due to the proposed update to the rate partially offset by a projected decrease in high-cost outlier payments in FY 2025 compared to FY 2024,” CMS wrote in a release.”
  • The Washington Post reports,
    • “The Environmental Protection Agency has finalized the nation’s first drinking water standard for “forever chemicals,” a group of persistent human-made chemicals that can pose a health risk to people at even the smallest detectable levels of exposure.
    • “The new rules are part of the Biden administration’s efforts to limit pollution from these per- and polyfluoroalkyl substances, or PFAS, which can persist in the environment for centuries. Exposure to PFAS has been linked to an increased risk of certain types of cancer, low birth weights, high cholesterol, and negative effects on the liver, thyroid and immune system.
    • “EPA officials estimate that the federal rule will reduce PFAS exposure in drinking water for about 100 million people.
    • “This is the first time the EPA has set a drinking water standard for a new contaminant since 1996. Some states — including Maine, Massachusetts, New Jersey and Washington — have already passed drinking water standards for certain PFAS.”
  • Govexec explains employer-sponsored dental benefits for federal employees and annuitants.
  • Reg Jones, writing in Fedweek, discusses “Extended Health Insurance Benefits for Children of Deceased Federal Employees and Retirees.”

From the public health and medical research front,

  • STAT News tells us,
    • “Cancer vaccines have traveled a potholed road over the last decade. But as researchers from different companies and academic institutions presented promising early data at the American Association for Cancer Research annual meeting in San Diego this week, experts said there’s a collective feeling of turning a corner.
    • “There’s a lot more interest in vaccines” now that the technology is improving, said Roy Herbst, chief of medical oncology at Yale Cancer Center.”
  • MedPage Today informs us that “Taking acetaminophen (Tylenol) during pregnancy was not associated with the development of autism or attention deficit-hyperactivity disorder (ADHD) in children, a large Swedish nationwide cohort study found.”
  • The National Institutes of Health informs us,
    • “Researchers at the National Institutes of Health applied artificial intelligence (AI) to a technique that produces high-resolution images of cells in the eye. They report that with AI, imaging is 100 times faster and improves image contrast 3.5-fold. The advance, they say, will provide researchers with a better tool to evaluate age-related macular degeneration (AMD) and other retinal diseases.
    • “Artificial intelligence helps overcome a key limitation of imaging cells in the retina, which is time,” said Johnny Tam, Ph.D., who leads the Clinical and Translational Imaging Section at NIH’s National Eye Institute.”
  • Per a Neurovalens press release,
    • “Modius Stress becomes company’s second product cleared for use in US 
    • “Neurovalens, a global leader in non-invasive neuro-technology, has received medical device clearance from the US Food & Drug Administration (FDA) to treat anxiety with its Modius Stress device.
    • “Based in Belfast, Neurovalens is a health-tech company that specialises in combining neuroscience and technology to tackle a range of global health challenges. 
    • “The company’s medical devices have been designed to deliver non-invasive electrical stimulation to key areas of the brain and nervous system without the need for surgically implanted electrodes. 
    • “Modius Stress is designed to treat anxiety by delivering a small and safe electrical pulse to the head for a period of 30 minutes before bed, during which users can do other activities, such as watching TV or reading.”  
  • Per a Bristol Myers Squibb press release,
    • “Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia. Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.
    • “We are pleased to see a continued and consistent meaningful reduction in symptoms of schizophrenia across 52-weeks in an outpatient setting, beyond what was seen in the short-term, in-patient five-week trials (EMERGENT-2 and EMERGENT-3),” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. “We look forward to continued conversations with the FDA and to sharing additional data from the EMERGENT program later this year.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Vertex Pharmaceuticals on Wednesday said it would buy biotechnology company Alpine Immune Sciences and its experimental kidney disease drug for $65 per share, or approximately $4.9 billion in cash.”Vertex Pharmaceuticals on Wednesday said it would buy biotechnology company Alpine Immune Sciences and its experimental kidney disease drug for $65 per share, or approximately $4.9 billion in cash.
    • “Through the deal, which the companies expect to close in the second quarter, Vertex will gain access to povetacicept, a therapy for IgA nephropathy, or IgAN. The drug is set to enter Phase 3 testing by the end of the year. 
    • “The acquisition is the largest in Vertex’s 35-year history and comes as the company works to expand into kidney disease treatment.”
  • Beckers Hospital Review relates,
    • “Three pharmacy benefit managers accounted for nearly 80% of all prescription claims handled in 2023, according to an April 9 report from the Drug Channels Institute.
    • “To compile the list, Drug Channels analyzed estimated total equivalent prescription claims managed across the industry in 2023. CVS Caremark, Express Scripts and OptumRX managed 79% of prescription claims last year, the same percentage as in 2022.” 
  • Beckers Payer Issues lets us know,
    • “AHIP, the American Medical Association and the National Association of ACOs have released a playbook of voluntary best practices for value-based care payment arrangements. 
    • “National Association of ACOs President and CEO Clif Gaus said that in the past decade, value-based care has grown from “almost nothing to an undeniably significant aspect of our health system,” according to a joint April 10 news release from the organizations. 
    • “This iteration of the playbook synthesizes what we’ve learned over the last decade plus, so that payers, physicians, hospitals and ACOs can implement payment and delivery models that improve outcomes and lower costs,” Dr. Gaus said.” 

Monday Roundup

David Ermer–FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Federal Times tells us,
    • “The federal government again processed a high number of retirement applications last month, even though its overall pace slowed.
    • “In March, the Office of Personnel Management packaged 680 more cases than it did the month before and took in about 850 fewer applications, chopping the backlog by 14%. The rate of processing was slightly slower than in February, but the average case is still being processed in roughly two months or less, which is OPM’s goal, according to the data.”
  • STAT News reports,
    • “For decades, the Food and Drug Administration’s accelerated approval pathway has helped companies get drugs for serious unmet medical needs to patients — and the market — sooner. But about half of cancer drugs approved via this route fail to improve patient survival or quality of life in subsequent clinical trials after more than five years of follow-up, according to new findings presented Sunday at the American Association for Cancer Research annual meeting.
    • “The data come from an analysis of cancer drugs granted accelerated approval over the past decade. In some cases, failure to show clinical benefit didn’t stop the FDA from converting accelerated approvals into full approvals, and the authors note the agency’s conversion decisions have increasingly been based on less stringent evidence of a drug’s benefits.
    • “The study also found evidence that drugs granted accelerated approval, meant to be a temporary designation, are spending less time in limbo. In 2013, it took an average of 9.9 years after accelerated approval for cancer drugs to be pulled from the market if follow-up trials didn’t show a benefit; by 2017, that timing dropped to 3.6 years.
    • “The findings, presented during a press briefing at the AACR meeting, were also published in the Journal of the American Medical Association. The study’s authors say the results aren’t an argument against the use of drugs available via accelerated approval, but underscore the importance of doctors communicating both the potential benefits and uncertainty surrounding these products to patients. They urged drugmakers to more routinely collect quality-of-life data during confirmatory studies, and the FDA to press companies to gather stronger evidence of clinical benefit to support a drug’s full approval.”

From the public health and medical research front,

  • The Washington Post and Consumer Reports explain what to do about jaw pain and when to worry.
  • STAT News lets us know,
    • “Cancer cases among younger people have been rising for years, a trend researchers have struggled to explain. New evidence suggests a significant factor: younger generations seem to be aging faster at the cellular level than their predecessors.
    • “A team of scientists at Washington University in St. Louis tracked data from nearly 150,000 people between the ages of 37 and 54 in the U.K Biobank, a massive biomedical database. They used nine blood-based markers to calculate their biological age, a measure that captures the overall state of a person’s cells and tissues.
    • “Sharing results on Sunday here at the American Association for Cancer Research annual meeting, they found that people born after 1965 were more likely to have a biological age that outpaced their chronological age. People with higher levels of accelerated aging had a 17% increased risk of developing any solid tumor cancer, with higher risk increases for lung, gastrointestinal, and uterine cancer.”
  • and
    • “A controversial heart pump from Abiomed reduced the number of deaths in severe heart attack patients, according to a highly anticipated randomized trial presented at the American College of Cardiology conference and published in the New England Journal of Medicine on Sunday.
    • “The trial, which took 10 years to enroll, followed 355 patients for 180 days in Denmark, Germany, and the United Kingdom who came into the hospital with a heart attack and dangerously low blood flow, known as cardiogenic shock. Half of the patients received standard care, which typically included medication and about 20% of the time included life support, and the other half received Abiomed’s left-sided heart pump, called the Impella, for 48 hours. * * *
    • “Though the Impella pump has been on the market for decades, there has never been a randomized controlled trial proving its benefit. The pump also comes with grave risks, puncturing ventricles or interfering with other heart devices if not properly inserted. Abiomed has been admonished by the Food and Drug Administration for not disclosing these risks to the agency as required under the law. Despite the safety risks and the lack of a randomized trial, the Impella has been widely adopted by interventional cardiologists, becoming a moneymaker for the device maker.
    • Several cardiologists STAT spoke with described Sunday’s results as a “striking” win for a patient population that has few treatment options proven to save lives.
  • and
    • “Novo Nordisk’s Wegovy improved symptoms and physical function in patients who had obesity, diabetes, and a common type of heart failure, boosting Novo’s attempt to get the popular drug approved for yet another usage beyond weight loss.
    • “The study, being presented here on Saturday at the American College of Cardiology conference and published in the New England Journal of Medicine, reports results from the second large trial Novo has conducted on Wegovy in heart failure with preserved ejection fraction, or HFpEF. The first trial, which showed positive results last year, was in patients who had obesity and HFpEF, but not diabetes.
    • “Novo said it submitted the results of these two trials to regulators earlier this year and is seeking approval for a new indication in HFpEF. Wegovy just last month got FDA clearancefor its first usage besides weight loss — preventing cardiovascular complications in people with heart disease.
    • “Wegovy is part of a booming class of diabetes and obesity treatments called GLP-1 drugs that deliver substantial amounts of weight loss, but they’re costly and have been slow to gain widespread insurance coverage. Getting additional indications beyond weight loss could boost drugmakers’ arguments that the drugs are worth their cost and help streamline coverage.”
  • The Wall Street Journal lets us know about “the calming power of rituals. Don’t just tell yourself to calm down: Adopting a routine for stressful moments—as many top athletes and performers do—can measurably reduce your agitation.
    • “A study by researchers at the University of Toronto showed exactly how this works. They taught subjects a physical ritual, then had them complete difficult button-pressing tests designed to induce errors, while monitoring their brain activity. The researchers were able to measure that an electrical response known as error-related negativity, or ERN, was reduced after subjects performed their rituals. In other words, participants were less focused on their mistakes, and that helped them stay closer to the moderate level of arousal ideal for performance under the Yerkes-Dodson law.
    • “No ritual has the power to make rock stars or savants out of us. We still have to contend with the realities of aptitude and proficiency and the discipline of daily practice. But rituals can give us a way to manage our nerves, dial into the skills we’ve worked so hard to achieve and give us that elusive something more that allows us to step into the spotlight and shine.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports
    • “For years now, there has been immense excitement for liquid biopsies—blood tests that can detect cancer early. Eventually, tests like the Galleri developed by Grail could revolutionize the practice of medicine by allowing patients to catch and treat the disease early.
    • “When it comes to colon cancer, though—the second biggest cause of cancer deaths behind lung cancer—blood-based tests have proved disappointing. The latest setback came last week, after privately held Freenome announced top-line results from a clinical study for the early detection of colon cancer among average-risk adults. The results failed to impress investors.  * * *
    • “The key reason Freenome’s results released last week didn’t excite investors is that they indicated the test wasn’t very good at catching precancer signs, which is the main thing doctors are looking for with early screenings. While the clinical study reported an overall 79.2% sensitivity in detecting colorectal cancer, it reported a sensitivity of 12.5% for detecting advanced adenomas, or precancerous polyps. That is far below the 42% sensitivity achieved by Cologuard [, a stool sample test.]”
  • Healthcare IT News discusses Rush Memorial’s virtual intensive care unit.
    • “The virtual ICU has enabled Rush Memorial surgeons to feel comfortable performing more surgeries, knowing there is the clinical expertise to care for those patients in recovery in the ICU.
    • “If you are considering implementing a technology like this to provide needed coverage in your hospital, I highly recommend it,” Tressler advised. “Just be sure you are finding a vendor that has done it before, that has the experience and expertise to help you set it up appropriately, as well as the flexibility to work with your existing workflows.”
  • Per Fierce Healthcare,
    • “Health insurers are gearing up to release their first-quarter results over the next several weeks, and a new analysis from Fitch Ratings finds that ongoing concern about utilization in Medicare Advantage (MA) has made for a cloudy outlook.
    • “The analysts wrote in the insurance dashboard report that payers with a significant presence in the MA space faced elevated medical loss ratios last year amid a spike in care utilization. Others, meanwhile, saw their MLRs decline last year, according to the report.
    • “The significant increase in 4Q23 senior market utilization reported by some companies creates significant uncertainty around profitability for the sector in 2024,” the analysts wrote.
    • “Despite the uncertainty, analysts at Fitch said earlier this year that the spike in utilization would likely be credit-neutral for the industry. In the dashboard report, the authors note that operating earnings before interest, taxes, depreciation and amortization was about 6.8% last year across the seven largest publicly traded insurers.”
    • “That’s a slight decrease from 7% in 2022, according to the report. These seven payers account for about 70% of membership in the U.S., according to the report.”
  • McKinsey & Co. explains how price transparency could affect U.S. healthcare markets.
    • “This article puts price transparency rules in context and explores their implications, including:
      • “the existence of price dispersion in US healthcare that is not explained by differences in quality of care
      • “how price transparency rules address some market inefficiencies driving this price dispersion but leave others unresolved
      • “that patients—if given proper incentives and information—would be interested in shopping for care that amounts to 20 to 25 percent of US healthcare claims spend, potentially unlocking gains in affordability for consumers
      • “the potential for price transparency rules, together with other innovations, such as advances in technology and analytics, to empower patients to shop for care more than ever, helping offset growth in healthcare costs
      • “implications for healthcare industry stakeholders, potential shifts in industry profit pools, and first-mover advantages for organizations that capitalize on this opportunity to improve healthcare for US consumers.”