Midweek Update

Patient safety

Midweek Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Hill informs us,
    • “Blockbuster weight-loss drug Wegovy could bankrupt the U.S. health care system unless the price drops, according to a staff report released Wednesday from the office of Senate Health Committee Chair Bernie Sanders (I-Vt.). 
    • “Unless prices dramatically decline, Wegovy and weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs, the report concluded.
    • “Pricing drugs based on their value cannot serve as a blank check, or the sole determinant for how we understand what to pay for essential goods,” the report stated. As important as these drugs are, they will not do any good for the millions of patients who cannot afford them.” 
    • “The report ups the pressure from Sanders on Danish drugmaker Novo Nordisk to lower the price of Wegovy and Ozempic.”
  • The good Senator has a point here. Drug manufacturers need a dose or two of price reasonableness.
  • STAT News reports,
    • “A House subcommittee on Thursday advanced legislation that would extend some pandemic-era telehealth policies in Medicare for two years, bringing the panel’s approach in line with another committee.
    • “During the pandemic, Congress extended flexibilities that changed what kinds of care Medicare beneficiaries could receive over telehealth and where. Originally, the House Energy and Commerce health subcommittee had considered a bill that would have enacted the policies permanently, but amended the legislation Thursday to pare it down to a two-year extension. The bill passed to the full committee unanimously on a 21-0 vote.
    • “The approach is in line with that of another panel, the House Ways and Means Committee, which passed a two-year extension earlier this month. Both bills include similar provisions that would pay for the extension in part through reforms to the way in which pharmacy middlemen operate.”
  • American Hospital Association News shares,
    • “The AHA shared a series of proposals to strengthen rural health care with the Senate Finance Committee for a hearing May 16 titled, “Rural Health Care: Supporting Lives and Improving Communities.” The proposals include policies promoting flexible payment options; ensuring fair, timely and adequate reimbursement; bolstering the workforce; and improving maternal health. During the hearing, several members focused on access to obstetric services and augmenting the number of medical residency slots awarded to rural hospitals. Jeremy P. Davis, MHA, president and CEO of AHA-member Grande Ronde Hospital in La Grande, Ore., and other health care leaders and policy researchers testified.”
  • The Department of Health and Human Services celebrates the Administration’s mental healthcare accomplishments.
  • The New York Times reports,
    • “The Food and Drug Administration on Thursday approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer, and have a life expectancy of four to five months. * * *
    • “Each year, about 35,000 Americans are diagnosed with small cell lung cancer and face a grim prognosis. The cancer usually has spread beyond the lung by the time it is detected. * * *
    • “The drug tarlatamab, or Imdelltra, made by the company Amgen, tripled patients’ life expectancy, giving them a median survival of 14 months after they took the drug. Forty percent of those who got the drug responded.
    • “After decades with no real advances in treatments for small cell lung cancer, tarlatamab offers the first real hope, said Dr. Anish Thomas, a lung cancer specialist at the federal National Cancer Institute who was not involved in the trial.
    • “I feel it’s a light after a long time,” he added.”
  • Tammy Flanagan, writing in Govexec, discusses FEHB annuitant reactions to Part D EGWP offerings in various FEHB plans for 2024.
  • Federal News Network notes,
    • After a couple years of uncertainty, satisfaction among federal employees is beginning to rise at many agencies.
    • In a preview of the latest Best Places to Work in the Federal Government rankings, out of the top 10 agencies in each of the four categories — large, midsize and small agencies, as well as agency subcomponents — prioritizing employee engagement was the common thread, the Partnership for Public Service said.
    • “At a time when our nation faces both critical challenges and exciting opportunities at home and abroad, an engaged federal workforce is vitally important,” Max Stier, president and CEO of the Partnership for Public Service, said in a statement. “The top-ranked agencies have excelled at keeping their workforces engaged and motivated and, as a result, they are well positioned to deliver results for the public.” * * *
    • “The Environmental Protection Agency, Energy Department, Office of Personnel Management and National Credit Union Administration all moved up in the rankings and increased their overall scores.” 
  • The CDC is promoting its new and improved website.

From the public health and medical research front,

  • The New York Times informs us,
    • “With Pride events scheduled worldwide over the coming weeks, U.S. officials are bracing for a return of mpox, the infectious disease formerly called monkeypox that struck tens of thousands of gay and bisexual men worldwide in 2022. A combination of behavioral changes and vaccination quelled that outbreak, but a majority of those at risk have not yet been immunized.
    • “On Thursday, the Centers for Disease Control and Prevention warned of a deadlier version of mpox that is ravaging the Democratic Republic of Congo and urged people at risk to be vaccinated as soon as possible. No cases of that subtype have been identified outside Africa so far. But the escalating epidemic in Congo nevertheless poses a global threat, just as infections in Nigeria set off the 2022 outbreak, experts said.
    • “This is a very important example of how an infection anywhere is potentially an infection everywhere, and why we need to continue to improve disease surveillance globally,” said Anne Rimoin, an epidemiologist at the University of California, Los Angeles. * * *
    • “The C.D.C. is focusing on encouraging Americans at highest risk to become vaccinated before the virus resurges. The agency’s outreach efforts include engaging with advocacy groups and social media influencers who have broad appeal among the L.G.B.T.Q. community. In December, the agency urged clinicians to remain alert for possible cases in travelers from Congo.”
  • and
    • “Heart disease, diabetes and kidney disease are among the most common chronic illnesses in the United States — and they’re all closely connected.
    • “Adults with diabetes are twice as likely to have heart disease or a stroke compared with those who don’t have diabetes. People with diabetes — Type 1 and Type 2 — are also at risk of developing kidney disease. And when the kidneys don’t work well, a person’s heart has to work even harder to pump blood to them, which can then lead to heart disease.
    • “The three illnesses overlap so much that last year the American Heart Association coined the term cardiovascular-kidney-metabolic syndrome to describe patients who have two or more of these diseases, or are at risk of developing them. A new studysuggests that nearly 90 percent of American adults already show some early signs of these connected conditions.
    • “While only 15 percent of Americans meet the criteria for advanced stages of C.K.M. syndrome, meaning they have been diagnosed with diabetes, heart disease or kidney disease or are at high risk of developing them, the numbers are still “astronomically higher than expected,” said Dr. Rahul Aggarwal, a cardiology fellow at Brigham and Women’s Hospital in Boston and co-author of the study.
    • “The research suggests that people should pay attention to shared risk factors for these diseases early on — including excess body fat, uncontrolled blood sugar, high blood pressure and high cholesterol or triglyceride levels.”
  • BioPharma Dive points out,
    • “An experimental Roche drug helped people with obesity lose an average of nearly 19% of their body weight over six months, after adjusting for placebo, in an early-stage trial, the company said Thursday.
    • “Roche is awaiting additional data from a study of the drug, called CT-388, in people with diabetes as well as obesity. It also didn’t provide specifics on the drug’s side effect profile. CT-388 is currently only in a Phase 1 program involving 96 people. Larger and longer trials are needed before the company can ask the Food and Drug Administration for approval.
    • “Roche acquired CT-388 through a $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to capture a share of a market estimated to be worth more than $100 billion annually by early next decade.”
  • and
    • “A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.”A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.
    • “Lilly is betting that its experimental drug, dubbed insulin efsitora alfa, could provide a longer-lasting and more convenient option than daily treatment for managing diabetes. 
    • “With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes,” said Jeff Emmick, a senior vice president of product development for Lilly, in a statement on the trial results.” 
  • The National Institutes of Health Director, in her blog, discusses “Speeding the Diagnosis of Rare Genetic Disorders with the Help of Artificial Intelligence.”
  • The National Institutes of Health announced,
    • “People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.”People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.
    • “Factors linked to this increased risk included having less than a high school education; a household income less than $35,000; not seeing a friend or relative in the past month; not having someone to care for them if ill or disabled; lack of health insurance; living in a disadvantaged neighborhood; and living in a state with low public health infrastructure. Apparent treatment-resistant hypertension is defined as the need to take three or more types of anti-high blood pressure medication daily and is associated with an increased risk for stroke, coronary heart disease, heart failure, and all-cause mortality.”
  • The U.S. Preventive Services Task Force released a final research plan for “Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral Counseling Interventions.”
  • Beckers Hospital Review alerts us,
    • “In 2023, patient falls were once again the most common sentinel event reported by healthcare organizations, according to a May 15 report from The Joint Commission.
    • “The Joint Commission defines a sentinel event as a patient safety event that results in death, permanent harm, severe temporary harm or intervention required to sustain life.
    • “The accrediting body received 1,411 reports of sentinel events in 2023, on par with the volume reported in 2022. Only a small portion of all sentinel events are reported to The Joint Commission, meaning conclusions about the events’ frequency and long-term trends should not be drawn from the dataset, the organization said.
    • “In total, 96% of healthcare organizations voluntarily reported sentinel events. About 18% of events were associated with patient death, 8% with permanent harm or loss of function, 57% with severe temporary harm and 12% with unexpected additional care or extended healthcare stays.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “One reason U.S. inflation is still high: Increases in prices for procedures to prop open clogged arteries, provide intensive care for newborns and biopsy breasts.
    • “Hospitals didn’t raise prices as early in the pandemic as supermarkets, retailers and restaurants. But they have been making up ground since then. Their increases have contributed to stubbornly high inflation readings from the consumer-price index, which in April increased 3.4% from a year ago. 
    • “Hospital prices specifically jumped 7.7% last month from a year ago, the highest increase in any month since October 2010, the Labor Department said Wednesday. * * *
    • Economists said they expect higher hospital inflation to persist as recent years’ labor-market disruption continues to ripple through wages and health-insurance contracts. 
    • “We’re not expecting much slowing,” said Alan Detmeister, an economist for UBS. “This was a very large shock that we saw in the healthcare industry over Covid, and it takes years for those to pass through to the prices.”
    • Hospital price increases are responsible for about 23% of the growth in U.S. health spending each year, on average, according to an analysis by federal actuaries for the Journal. Health-insurance premiums last year shot up at the fastest rate in a decade. 
    • Premiums rise with health spending. Public employees in California saw premiums increase 11% this year, largely because of rising prices, which alone raised their premiums by 8%, said the California Public Employees’ Retirement System. 
  • Healthcare Finance adds,
    • The Centers for Medicare and Medicaid Services’ January [2024] expansion of the two-midnight rule to include Medicare Advantage plans has contributed to higher inpatient volumes and revenue growth in the first quarter of the year, according to a Strata Decision Technology report.
    • This is because inpatient services have higher reimbursement levels compared to outpatient services and the two-midnight rule concerns inpatient care.
  • Per Fierce Healthcare,
    • “Though held in check by inflation, Cleveland Clinic’s first-quarter operations trickled past last year’s tally thanks to a jump in volumes and revenues.
    • The nonprofit system reported this week a $50.2 million operating gain (1.3% operating margin), as opposed to the prior year’s $32.3 million (0.9% operating margin). Operating revenues rose 10.2% year over year to nearly $3.9 billion while operating expenses followed close behind with a 9.8% increase.
    • “Cleveland Clinic enjoyed “strong demand for both inpatient and outpatient services” during the quarter, management wrote in commentary on its operations. Compared to the prior year, acute admissions rose 6.7%, total surgical cases by 3.7% and outpatient evaluation and management visits by 3.9%.
    • “The system’s 9.4% increase in net patient service revenue was also boosted by rate increases among Cleveland Clinic’s managed care contracts that went into effect with the new year. Additionally, management wrote, “over the last few years, the system initiated national, regional and local revenue management projects designed to improve patient access throughout the system while striving to ensure the safety of patients, caregivers and visitors.”
  • According to Healthcare Dive,
    • “[Philadelphia based] Jefferson Health and [Allentown, PA, based] Lehigh Valley Health Network signed a definitive agreement Wednesday to merge. The health systems expect the deal to close later this summer, pending regulatory approval, according to a press release. Deal terms were not disclosed.”
  • Fierce Healthcare adds,
    • “UnitedHealth Group’s investments in affordable housing have topped $1 billion, with the program a keystone in its overarching strategy to address health equity and disparities.
    • “The company has made investments in housing since 2011 and, in that time, has supported the development of affordable and mixed income units across 31 states and the District of Columbia, creating more than 25,000 homes for people and families who face housing insecurity.
    • “The investments include direct funding from the company as well as those made through Low-Income Housing Investment Tax Credits and Community Reinvestment Act loans, UnitedHealth said. The company has backed both new development and rehabilitation for older locations in urban, suburban and rural markets. * * *
    • “UnitedHealth is tracking the health benefits of these investments and spent two years measuring outcomes against a baseline set by Stewards of Affordable Housing for the Future and the National Affordable Housing Trust. It found that people living in the properties it backed were more likely to receive annual checkups, with 95% having one in the past year.
    • “In addition, residents living in these locations reported better mental health compared to low-income individuals across the country.”

Midweek Update

David Ermer–FDA, Medicare, NIH, No Surprises Act, Patient safety, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

From Washington, DC,

  • The No Surprises Act regulators alert us,
    • “On October 6, 2023, the Departments and OPM issued FAQs About Consolidated Appropriations Act, 2021 Implementation Part 62 (FAQs Part 62). In FAQs Part 62, the Departments and OPM acknowledged the impact of the TMA III decision on QPAs and the significant resources and challenges associated with recalculating QPAs. Therefore, the FAQs stated that the Departments and OPM would exercise their enforcement discretion under the relevant No Surprises Act provisions for any plan or issuer, or party to a payment dispute in the Federal IDR process, that uses a QPA calculated in accordance with the methodology under the July 2021 interim final rules and guidance in effect immediately before the decision in TMA III, for items and services furnished before May 1, 2024, the first day of the calendar month that is 6 months after the issuance of FAQs Part 62. Under FAQs Part 62, this exercise of enforcement discretion applies to QPAs for purposes of patient cost sharing, providing required disclosures with an initial payment or notice of denial of payment, and providing required disclosures and submissions under the Federal IDR process.
    • “FAQs Part 62 stated that HHS would also exercise enforcement discretion under the relevant No Surprises Act provisions for a provider, facility, or provider of air ambulance services that bills, or holds liable, a participant, beneficiary, or enrollee for a cost-sharing amount based on a QPA calculated using the aforementioned method.”
    • The regulators have extended the safe harbor to services or supplies rendered before November 1, 2024. The regulators do not expect to further extend the safe harbor.
  • The Wall Street Journal reports,
    • “As part of the government’s quest to improve American eating habits, the Food and Drug Administration is considering requiring food manufacturers to put new labels on the front of packages. The labels might flag certain health risks, such as high levels of salt, sugar or saturated fat.
    • “Don’t expect to see a warning label in your grocery store soon, because the FDA is still weighing its approach. But the agency hopes that clearer food labeling could help us make healthier choices as it tackles the rise of diet-related health problems such as Type 2 diabetes and cardiovascular disease.” 
  • Fierce Healthcare discusses the new HHS rule here.

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two decades ago, the shocking results of a major women’s health study challenged the safety of menopause hormones, and overnight, millions of women and their doctors abandoned the drugs — a reluctance that lingers today.
    • “Now, a long-term follow-up of the Women’s Health Initiative (WHI) shows that the reaction was largely overblown. The new research found that for many younger menopausal women — typically those under 60 — the benefits of the drugs probably outweigh the risks for the short-term treatment of menopause symptoms, including hot flashes and night sweats.
    • “The new analysis, published in JAMA, shows that younger women starting menopause and experiencing symptoms can take hormone treatments for several years with a lower likelihood of adverse effects.
    • “Women in early menopause with bothersome symptoms should not be afraid to take hormone therapy to treat them, and clinicians should not be afraid to prescribe them,” said JoAnn Manson, chief of the division of preventive medicine at Brigham and Women’s Hospital and the paper’s first author.”
  • The New York Times informs us,
    • “Baby aspirin is routinely prescribed to people who survive heart attacks. But there’s another vulnerable group who benefit from daily low-dose aspirin: pregnant women at risk of developing pre-eclampsia, life-threatening high blood pressure.
    • “It’s a factor in up to one in 20 pregnancies in the United States, and one of the leading causes of maternal mortality nationwide. Pre-eclampsia is the top cause of maternal death among Black women, who die of pregnancy-related complications at rates almost triple those of white women.
    • “But not enough pregnant women are getting the word that low-dose aspirin can help. Now leading experts are hoping to change that.”
  • STAT News tells us,
    • “Extensive testing of pasteurized commercially purchased milk and other dairy products from 38 states has found no evidence of live H5N1 bird flu virus, Food and Drug Administration officials said at a press briefing Wednesday.
    • “The results confirmed findings of earlier testing of a more limited number of samples and add weight to the FDA’s conclusion that pasteurized milk products are safe for consumption despite a widespread outbreak of cows infected with H5N1.
    • “These additional, preliminary results further affirm the safety of the U.S. commercial milk supply,” Donald Prater, acting director of the FDA’s Center of Food Safety and Applied Nutrition, told reporters.”
  • The National Institutes of Health announced,
    • “Recurring feelings of anger may increase a person’s risk of developing heart disease by limiting the blood vessels’ ability to open, according to a new study supported by the National Institutes of Health. The study, published in the Journal of the American Heart Association (JAHA), shows for the first time that anger is linked to this vascular impairment — a precursor to the kind of long-term damage that can lead to heart attack and stroke.
    • “We’ve long suspected, based on observational studies, that anger can negatively affect the heart. This study in healthy adults helps fill a real knowledge gap and shows how this might occur,” said Laurie Friedman Donze, Ph.D., a psychologist and program officer in the Clinical Applications and Prevention Branch of the National Heart, Lung, and Blood Institute (NHLBI), which funded the study. “It also opens the door to promoting anger management interventions as a way to potentially help stave off heart disease, the leading cause of death in this country.”
    • “While a brief spurt of occasional anger is normal and generally has a benign impact on the heart, it is recurring or frequent anger the researchers said raises concern. “If you’re a person who gets angry all the time, you’re having chronic injuries to your blood vessels,” said study leader Daichi Shimbo, M.D., a cardiologist at Columbia University Irving Medical Center in New York City. “It’s these chronic injuries over time that may eventually cause irreversible effects on vascular health and eventually increase your heart disease risk.”

From the U.S. healthcare business front,

  • Healthcare Dive notes,
    • “CVS had a significantly worse first quarter than the healthcare giant — or Wall Street — expected, after its insurance arm failed to adequately prepare for seniors’ high use of medical care, especially in inpatient facilities.
    • “The Rhode Island-based company’s health services segment — usually a reliable driver of growth — also saw its revenue and income fall in the quarter as its pharmacy benefit manager adjusted to the loss of a major contract with insurer Centene.
    • “CVS slashed its earnings expectations for 2024 on Wednesday following the results. It’s the second time the company has lowered financial expectations this calendar year.” 
  • Fierce Healthcare adds,
    • “CVS has quietly acquired Hella Health, a startup Medicare Advantage (MA) broker based in New York City, according to a post on LinkedIn.
    • “Financial terms of the deal were not disclosed, but Hella Health CEO and founder Rafal Walkiewicz wrote in the post that the combination allows the healthcare giant to further bolster its suite of technology platforms, especially those offered directly to the senior population.
    • “Through this combination, CVS Health will expand its multi-payer technology platform to include a wide range of insurance offerings, supported by trusted advisors and agents, to provide a simple, direct-to-consumer Medicare shopping and enrollment experience,” Walkiewicz wrote.”
  • The Leapfrog Group released its Spring 2024 Hospital Safety Grades.
  • Per BioPharma Dive,
    • “GSK on Wednesday raised its financial forecasts for the year following strong quarterly sales of its vaccines and HIV medicines. 
    • “GSK said vaccine sales surged 16% compared to the same period a year ago, a number driven by revenue totals for its shingles shot Shingrix and RSV vaccine Arexvy. New public immunization programs in Europe and other international market drove sales of Shingrix, while Arexvy continued to take more market share than Pfizer’s rival RSV shot Abrysvo.  
    • “The company now expects its 2024 sales to grow at the higher end of the 5% to 7% range it previously projected, and for annual adjusted earnings per share to climb 8% to 10%. Still, GSK warned that growth could slow later this year amid shifting seasonal patterns for vaccinations and changes in market dynamics.”

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.”

Tuesday Tidbits

David Ermer–COVID-19, Cybersecurity, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Because this is the FEHBlog, the lede tonight necessarily is OPM’s announcement naming the carriers who are currently prepared Postal Service Health Benefit Program benefit and rate proposals. Good luck to them all.
  • FedWeek notes,
    • “President Biden has issued an open letter to federal employees thanking them for their “tireless service on behalf of our country.”
  • and
    • “While seeking a January 2025 raise of 2 percent (see related story), the White House’s fiscal 2025 budget proposal cites several initiatives related to federal pay.
    • “In addition to year-to-year pay increases, the Administration is pursuing structural reforms to enhance the competitiveness of the Federal pay system,” it says.
  • Reg Jones, writing in Fedweek, fills us in on benefits available upon the death of a federal employee or annuitant.
  • The Department of Health and Human Services provided a readout from “Biden-Harris Administration Convening with Health Care Community Concerning Cyberattack on Change Healthcare. Leaders from HHS, White House, DOL, and the health care community convened to discuss ways to mitigate harms to patient and providers caused by the cyberattack.”
  • The Food and Drug Administration “advised consumers in Some Medicines and Driving Don’t Mix to make sure they know if their prescription or over-the-counter medication can cause side effects that may make it unsafe to drive. Most medications won’t affect consumers’ ability to drive safely or operate other heavy machinery, but some do.”
  • The Buck consulting firm points out why “maintaining creditable coverage may prove difficult for some employer sponsored plans in 2025.”
  • STAT News discusses the treatment impact of new federal methadone rules.
    • “The federal government is reforming methadone care for the first time in over two decades. But how far do the changes actually go?
    • “To many methadone clinics, the Biden administration’s recent refresh of the rules governing opioid treatment programs represents an unprecedented opportunity to offer care that is more compassionate and responsive to patients’ needs. To many patient advocates, however, it simply nibbles around the edges. 
    • “The reality is likely somewhere in between: It will depend, in large part, on whether state-level regulators embrace the changes, and whether individual clinics actually implement them. In reform-oriented states, and at patient-centered clinics, the new rules could make a world of difference for people seeking addiction treatment.” 
  • The Office of National Coordinator for Healthcare Information Technology, Micky Tripathi, in his blog, looks forward to “HTI-2 & ONC’s Commitment to Furthering the Vision of Better Health Enabled by Data.”

From the public health and medical research front,

  • BioPharma Dive reports,
    • “Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday.
    • “A majority of patients receiving the highest dose of the drug, which is specially designed to penetrate brain tissue, saw their amyloid levels drop below detectable levels after 12 weeks, Roche executives said in an investor presentation on the pharmaceutical giant’s neurology pipeline.”
  • Reuters tells us, “Pfizer  said on Tuesday its drug, Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen [in 2023].
  • MedPage Today lets us know,
    • “Pragmatic implementation of an automated online behavioral obesity treatment program that included 9 months of active maintenance helped people with overweight or obesity lose a clinically significant amount of weight by 12 and 24 months, a randomized trial showed. * * *
    • “This pattern persisted at 24 months, reported J. Graham Thomas, PhD, of the Weight Control and Diabetes Research Center in Providence, Rhode Island, and colleagues in JAMA Internal Medicine.
    • “This study shows that a fully automated online obesity treatment program can produce beneficial results for many patients in real-world primary care settings,” Thomas told MedPage Today. “We were encouraged to find that the online weight-loss program performed just as well in real-world primary care practices as it does in our previous highly controlled clinical trials.”
    • “These patients lost weight “at rates comparable” to those seen in studiesopens in a new tab or window in which the researchers were completely hands-on in every aspect of the program, he added.
    • “Because the treatment program is online and fully automated, Thomas said it is quite practical for widespread implementation across primary care practices. “The data show that the primary care clinicians were able to implement the program independently, and patients were able to use it successfully.”
  • Beckers Hospital Review adds,
    • “Hospital transplant departments have strict cutoffs for patients with higher body mass indexes because of the increased risk of complications, but GLP-1s such as Ozempic and Wegovy are helping more patients be eligible for surgery. 
    • “Potential transplant donors and diabetic patients who otherwise would not be able to undergo surgery because of their BMI are now quickly dropping weight. Popular GLP-1s, including Ozempic, and GLP-1s and glucose-dependent insulinotropic polypeptides, such as Mounjaro and Zepbound, are dramatically helping these weight loss efforts.” 
  • Medscape cautions,
    • “Novo Nordisk’s CEO on Friday said the company was working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of patient harm across the world.
    • “This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drugmaker, told Reuters. * * *
    • “Jorgensen, echoing comments from the FDA’s Califf, also said compounded semaglutide in the United States was a serious health issue, and that the raw materials, or active pharmaceutical ingredients (API), for these products were coming from unregulated facilities in Asia and elsewhere. 
    • “We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product,” he said.
    • “While fake drugs often do not contain any of the medication advertised, compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. Because Wegovy and Ozempic are in short supply, they can be legally produced by licensed pharmacies in the U.S.
    • “Further reports obtained by Reuters through FOIA requests show that one person died last year from abnormal blood clotting after taking a drug that was advertised as compounded semaglutide. Three others suffered severe vomiting and nausea, sensory loss in their legs, and a drop in blood platelet levels.”
  • The U.S. Census Bureau announced,
    • “An additional 573,000 people died in the United States during the first year of the COVID-19 pandemic but “excess mortality” at the national level masks substantial variations by state, age, sex, and race and ethnicity, according to new U.S. Census Bureau research recently published in Demography.
    • “Excess mortality” refers to deaths from any cause above what is expected from recent mortality trends.
    • “This research shows the pandemic widened the mortality gap between the nation’s Black and White populations and completely erased the mortality advantage of the Hispanic population in relation to the non-Hispanic White population.”
  • The National Institutes of Health announced‘,
    • “Two phase 2 clinical trials to test the safety and effectiveness of three treatments for adults with autonomic nervous system dysfunction from long COVID have begun. The autonomic nervous system acts largely unconsciously and regulates bodily functions, such as heart rate, digestion and respiratory rate. Symptoms associated with autonomic nervous system dysfunction have been among those that patients with long COVID say are most burdensome. The trials are part of the National Institutes of Health’s Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program to fully understand, diagnose and treat long COVID. Other RECOVER phase 2 clinical trials testing treatments to address viral persistence and neurological symptoms, including cognitive dysfunction (like brain fog), launched in July 2023. * * *
    • “People 18 years of age and older who are interested in learning more about these trials can visit https://trials.RECOVERCovid.org/autonomic or ClinicalTrials.gov and search identifier NCT06305793, NCT06305806 and NCT06305780. Please do not contact the NIH media phone number or email to enroll in these trials.”
  • The Wall Street Journal warns,
    • “Ultra-processed foods may not only affect our bodies, but our brains too.
    • “New research suggests links between ultra-processed foods—such as chips, many cereals and most packaged snacks at the grocery store—and changes in the way we learn, remember and feel. These foods can act like addictive substances, researchers say, and some scientists are proposing a new mental-health condition called “ultra-processed food use disorder.” Diets filled with such foods may raise the risk of mental health and sleep problems. 
    • “The science is still early and researchers say there is a lot they don’t know. Not all ultra-processed foods are equal, some scientists say, adding that some might be good for you. A diet high in ultra-processed foods has been linked with obesity, Type 2 diabetes, cancer and cardiovascular disease, but researchers are still figuring out exactly why, beyond calorie counts and nutrient composition. 
    • “Makers of foods such as processed meats and muffins defend their products, and note that there isn’t a consistent, universally accepted definition of ultra-processed food.”

From the HIMSS Conference in Orlando,

  • HIMSS offers an article about “Google Cloud’s debut of new genAI advancements for healthcare at HIMSS24. In total, the company is offering its cloud clients updates to Vertex AI Search, Healthcare Data Engine and MedLM, designed to improve patient care.”

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Nearly half of U.S. workers don’t have the benefits they need at work, according to the results of a survey by Perceptyx, an employee experience company. Of the 1,500 full-time employees surveyed, 59% said they had “benefits envy” of friends’ and family members’ healthcare coverage.
    • “When it comes to benefits equity, the survey found that medical, maternity and mental health are the “magic trifecta,” Emily Killham, senior director of people analytics, research and insights at Perceptyx, said. “When employees have access to all three, women and men feel equally that their needs are met.”
    • “Yet 53% of those surveyed said they don’t have mental health coverage, 51% don’t have maternity leave, and 25% don’t have any medical benefits, per the results.”
  • Beckers Hospital Review informs us,
    • “Healthgrades recognized 832 hospitals with its 2024 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 79 of those hospitals received both awards. 
    • “The dual recipients spanned 27 states. Texas had the most dual recipients with 13 honorees — including four Baylor Scott and White Health and four Houston Methodist hospitals.”
    • The article lists the dual recipients.
  • Beckers Payer Issues relates,
    • “Selective contracting with primary care physicians may be one factor behind lower per-patient expenses in Medicare Advantage, a study published in the March edition of Health Affairs found. 
    • “The study examined 4,456,037 traditional Medicare patients who visited 151,679 primary care physicians. The physicians who participated in Medicare Advantage networks had $433 lower costs per patient than the regional average of physicians. 
    • “The quality measures for physicians participating in Medicare Advantage were similar to the regional average, the study found. 
    • “Physicians who did not participate in any MA networks cost $1,617 more per patient per year than those participating in MA networks, and they had lower quality measures. 
    • “The findings suggest that “managed care tools, particularly selective contracting with primary care physicians” contribute to lower costs in Medicare Advantage, the authors concluded. Though the differences in cost are most likely attributable to differences in practice style, that could also serve as a mechanism for plans to select healthier patients, the authors wrote.” 
  • Health Payer Intelligence adds,
    • “The average Medicare Advantage premium has remained low and stable, with many beneficiaries choosing plans with a zero-dollar monthly premium, according to data from eHealth, Inc.
    • “eHealth’s seventh annual Medicare Index Report includes data from over 190,000 applications for Medicare insurance products submitted to eHealth during the annual enrollment period for 2024 coverage.
    • “The average monthly premium for Medicare Advantage plans chosen by eHealth customers for 2024 is $9, the same as last year and up slightly from $6 in 2022. The popularity of plans with zero-dollar premiums contributed to the low average.”
  • HealthDay informs us,
    • “The cost to American families of caring for a child with a mental health condition jumped by almost a third between 2017 and 2021.
    • “It now costs an average $4,361 more per year for a U.S. family to care for a child with a mental health condition, compared to families without such children, a new study has found.” 

Monday Roundup

David Ermer–AHRQ, COVID-19, Electronic health records, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “President Biden proposed Monday a $7.3 trillion budget for the next fiscal year that would raise taxes on wealthy people and large corporations, trim the deficit and lower the costs of prescription drugs, child care and housing.
    • “The proposal isn’t expected to gain momentum in Congress, but will be a cornerstone of Biden’s re-election campaign as he looks to contrast his economic policies with those of presumed Republican presidential nominee Donald Trump. The administration has yet to reach an agreement with Congress on the budget for the current fiscal year, which began Oct. 1, and House Republicans have blasted Biden’s new proposal as reckless.
    • “The fiscal 2025 budget would cut the deficit by $3 trillion over the next decade, and it would raise taxes by a net total of $4.9 trillion, or more than 7% above what the U.S. would collect without any policy changes.” 
  • Here’s a link to the OMB page for the FY 2025 budget.
  • The Department of Health and Human Services offers a fact sheet on the budget measures impacting health insurance.
  • Govexec delves into the significant program reforms found in the budget details.
  • Federal News Network adds,
    • “For 2025, the White House is pushing for a more modest 2% federal pay raise for the roughly 1.5 million federal employees on the General Schedule.
    • “If enacted, most civilian federal employees would see the boost to their paychecks starting in the first full pay period of January 2025. Military members would receive a 4.5% raise next year, according to the budget request.
    • “The percentage adjustment would be the smallest pay raise since President Joe Biden took office. Federal employees received raises of 5.2%, 4.6% and 2.7%, in 2024, 2023 and 2022, respectively. In all three years, Biden’s federal pay raise proposals were finalized without intervention from Congress.
    • “The Biden administration said it opted for the smaller raise proposal for 2025 due to financial constraints agencies are expected to face over the next fiscal year.”
  • The U.S. Office of Personnel Management posted its FY 2025 Congressional Budget Justification and Annual Performance Plan. Here are OPM’s legislative proposals for FEDVIP and FEHBP/PSHBP:
    • “Expand Family Member Eligibility Under FEDVIP;
    • “Expand FEDVIP to Certain Tribal Employers;
    • “Expand FEHB to Tribal Colleges and Universities;
    • “Preempt State/Local Taxation of FEDVIP Carriers to Align with FEHB Carriers;
    • “Shorten FEDVIP Contract Terms to Allow Flexibility for New Carriers;
    • “Require Coverage of Three Primary Care Visits and Three Behavioral Health Visits Without Cost-Sharing;
    • “Limit Cost-Sharing for Insulin at $35 per Month.”
  • These proposals generally are retreads from earlier performance plans. If at first you don’t succeed, etc.

From the patient safety front,

  • HHS’s Agency for Healthcare Research and Quality reminds us that this is Patient Safety Awareness Week.
  • Fierce Healthcare tells us,
    • “Through no fault of their own, clinicians who started practicing medicine in the last several years didn’t have the same early experience as those who came before them–before the pandemic laid bare critical weaknesses in our healthcare system,” Marcus Schabacker, M.D., president and CEO of ECRI, said in a release. “ECRI’s top patient safety concern is a call to action to set new clinicians up for success through a ‘total systems safety’ approach and assess and redesign the environments in which clinicians are trained, onboarded, mentored and supported.”
    • “Among the recommendations proposed by ECRI and its affiliate, the Institute for Same Medication Practices (ISMP), in the patient safety report are new collaborative partnerships between healthcare and academic to support hands-on and simulation-based learning, as were wellness programs and adopting “a culture of safety that empowers newly trained clinicians to report safety events.”
    • “Just behind new hire challenges in ECRI’s 2024 ranking was concern that healthcare staff’s workarounds for barcode medication administration systems could lead to an increase in medication safety events.
    • “These workarounds occur when drug’s barcode can’t be scanned due to damage on a label, or when a medication hasn’t yet been added to an organization’s system, ECRI explained. This can lead to back-charting, proxy scanning, unlogged medication administration and ignored system alerts, and has historically been to blame for a majority of technology-related medication safety issues, according to the report.”
  • USAA Today reports,
    • “Beginning this year, the Centers for Medicare & Medicaid Services announced it would cover navigation services for older Americans on Medicare. The agency also established billing codes for hospitals and doctors to bill health insurance companies for navigator services.
    • “The Biden administration announced that seven large private health insurance companies have agreed to cover navigator services: Aetna, Blue Cross Blue Shield of Minnesota, Elevance Health, Health Alliance Plan, Humana, Priority Health and Select Health.
    • “In addition, 40 cancer care centers and clinics will extend navigator services to patients. The list includes high-profile cancer care centers such as Dana-Farber Cancer Institute in Boston, the Duke Cancer Institute, Northwell Health and the Mayo Clinic.
    • “This is about making sure that a growing number of Americans can get access as they need it,” Arati Prabhakar, director of the White House Office of Science and Technology Policy, told USA TODAY. “The companies that have signed up to provide insurance coverage for these services … reach 150 million Americans.”

From the Food and Drug Administration front,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results that proved the medicine can protect heart health. 
    • “The agency on Friday approved use of Wegovy to reduce the risk of heart attacks, strokes or death in people with cardiovascular disease and who are either obese or overweight. The drug should be used alongside exercise and a reduced-calorie diet, the agency said. 
    • “Wegovy, part of a popular class of medicines that control blood sugar and appetite, is already approved for use in treating obesity. The drug generated about $4.5 billion in sales in 2023 despite manufacturing issues that made it difficult for the company to meet surging demand.” * * *
    • “The FDA clearance issued Friday is one step in that direction. It was based on the results of a large study, the results of which were published in The New England Journal of Medicine last year, showing that treatment with Wegovy reduced the risk of heart attack, stroke or cardiovascular death by 20% compared to a placebo.” 
  • MedTech Dive lets us know,
    • “A Food and Drug Administration advisory committee has voted that the benefits of a new agent used in Lumicell’s breast cancer imaging tool outweigh the risks.
    • “The committee, which convened last week, assessed evidence that the tool can detect residual cancer in real-time during breast conserving surgery. Detecting residual cancer during surgery could reduce the need for additional procedures.
    • “While the committee supported the risk-benefit profile of the agent, pegulicianine, by a 16-2 vote, many of the experts noted its limitations, with one panelist who voted yes saying that the “incremental benefits outweigh the small risks of anaphylaxis.”

From the public health and medical research front,

  • David Leonhardt writing in the New York Times reflects on the fourth anniversary of the beginning go of the Covid shutdown in the U.S.
  • The American Medical Association tells us what doctors wish their patient knew about sickle cell disease.
  • The Institute for Clinical and Economic Review posted a “Final Evidence Report on Treatment for Schizophrenia — An independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for KarXT compared to generically available aripiprazole; if long-term data confirm KarXT’s benefits and lack of weight gain, it would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year.
  • Beckers Hospital Review relates,
    • “Pfizer’s shortage of penicillin G benzathine injection, an antibiotic for syphilis and other bacterial infections, is now predicted to last until the end of 2024. 
    • “Pfizer previously said the medication’s supply would rebound by the end of June, but in a March 8 update on the FDA’s drug shortage website, the drugmaker said the estimated recovery date is the fourth quarter of 2024. 
    • “Two solutions are in limited availability and another, the 600,000 [iU]/1 mL solution, is unavailable until its next shipment in April. 
    • “The FDA first reported the supply issue in April 2023, and Pfizer then said it would end within five months. A year later, clinicians are rationing penicillin, and the U.S. is importing solutions from a France-based drugmaker as syphilis rates dramatically increase.”

From the HIMSS global conference front,

  • This week, HIMSS is holding its popular global conference in Orlando, Florida.

From the U.S. healthcare business front,

  • Fierce Healthcare discusses lobbying efforts to obtain a Congressional extension of Medicare’s hospital at home program.
  • Healthcare Dive notes,
    • “Elevance Health said on Monday it closed its deal to acquire infusion and drug therapy company Paragon Health.
    • “Under the deal, the insurer will expand Plano, Texas-based Paragon’s real estate footprint and scale up operations, according to the announcement. Paragon will operate under CarelonRx, Elevance’s pharmacy services segment.
    • “An Elevance spokesperson declined to share financial terms of the deal. However, Axios, citing sources familiar, reported the purchase would run Elevance over $1 billion.”
  • Beckers Hospital Review ranks 34 health systems by operating margin.
  • Medscape informs us,
    • “A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were.
    • “The civil suit alleges that Aledade, Inc.’s, billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records.
    • “Aledade did whatever it took to make patients appear sicker than they were,” according to the suit.”
  • HR Dive reminds us,
    • “The U.S. Department of Labor’s independent contractor final rule went into effect Monday, after businesses scrambled last week to have it enjoined or halted through a preliminary injunction. 
    • “DOL announced the final rule in January, more than a year after it proposed changes to its evaluation of workers’ independent contractor status in October 2022. 
    • “The new “totality-of-the-circumstances” framework uses six nonexhaustive factors to determine workers’ independent contractor status, including the nature and degree of control over the work, extent to which the work performed is an integral part of the employer’s business and permanence of the arrangement. 

Monday Roundup

David Ermer–AHRQ, CDC, FDA, Generative AI, Medical / Rx research, Obesity, Patient safety, SDOH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Tomorrow at 10 am, the House Oversight and Accountability Committee will mark up several bills including the FEHB provisions in the DRUG Act, HR 6283. It’s unfortunate that the Committee did not hold a hearing on this disruptive bill. The FEHBlog will be listening to the markup.
  • The Federal Times informs us,
    • “A pair of contracts designed to improve the quality of care in Tricare’s civilian medical networks will take effect Jan. 1, 2025, according to defense officials.
    • “The contracts are moving forward following a Jan. 31 decision in the U.S. Court of Federal Claims affirming the Defense Health Agency’s choice of TriWest Healthcare Alliance as the Tricare West Region’s new manager, denying a protest lodged by incumbent contractor Health Net Federal Services last year.  * * *
    • “Humana Government Business, the incumbent contractor for Tricare’s East Region, will continue in that role under a new deal worth up to $70.8 billion.The new contracts for the two regions have a potential combined value of $136 billion over nine years.”
  • MedTech Dive lets us know
    • “FDA panel recommends new standards for pulse oximeters amid bias concerns.
    • “Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.”
  • and
    • “Hologic has received regulatory clearance to sell an artificial intelligence (AI)-enabled cervical cancer screening system in the U.S. 
    • “The product, the Genius Digital Diagnostics System, creates digital images of Pap test slides and uses an AI algorithm to identify cells that cytologists and pathologists should review.
    • “Hologic’s clearance, announced on Thursday, comes days after BD partnered with Techcyte to promote a digital, AI-enabled cervical cancer screening test that is yet to come to market.”

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “Eli Lilly’s ingredient for Type 2 diabetes medication Mounjaro and its new weight loss drug, Zepbound, significantly lowered patients’ blood pressure by up to 10.6 mmHg, according to a new study published Feb. 5. 
    • “The study recruited about 500 adult patients with a body mass index at or more than 27, or the overweight range. Compared to a placebo, tirzepatide — the active pharmaceutical ingredient of Mounjaro and Zepbound — reduced blood pressure for participants taking 5, 10 and 15 milligrams each week. The patients were not diabetic and either had normal blood pressure or high blood pressure that was under control.” 
  • STAT News reports,
    • “Amgen is trying a unique strategy with its obesity drug candidate: testing whether it can wean patients toward lower or less frequent doses over time.
    • “Very early data hints that Amgen’s candidate, called MariTide, may provide longer-lasting weight loss than highly popular obesity drugs on the market like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. Amgen is already seeing if that means its drug could also be dosed differently from Novo and Lilly’s products, which are costly and expected to be taken consistently for life.
    • “In an ongoing Phase 2 trial, Amgen’s researchers will first titrate participants up on MariTide, but then after some time, see if the drug can still be effective when transitioning patients to a less intensive dosing regimen, executives said in an interview.
    • “Could there be an opportunity for an induction maintenance-type of strategy for a molecule like MariTide?” said Narimon Honarpour, senior vice president of global development at Amgen, referring to a strategy used for anti-inflammatory drugs in which high, rapid doses are given at the start and then lower or less frequent doses are used for maintenance in the long run.”
  • HHS’s Agency for Healthcare Research and Quality released a rapid evidence report about deprescribing to reduce medical harms in older adults.
    • “Deprescribing has emerged as a clinical practice to reduce polypharmacy and use of potentially inappropriate medications (PIMs) and serve as a mechanism for quality improvement and increased patient safety. The purpose of this rapid response is to summarize recent literature on the use of deprescribing to improve the safety of medication use among older adults (age ≥ 65 years).”
  • CBS News reports,
    • “Preterm and early-term births in the U.S. have increased from 2014 to 2022, raising risks to babies, according to new data from the Centers for Disease Control and Prevention.
    • “Data released Wednesday from the CDC’s National Center for Health Statistics shows the preterm birth rate — meaning delivery before 37 completed weeks of pregnancy — rose 12% during that time period, while early-term birth rates, at 37 to 38 completed weeks, rose 20%. 
    • “This is compared to full-term births, which are those delivered at 39 to 40 weeks.
    • “Using data from the National Vital Statistics System, the analysis only looks at singleton births, since multiple births like twins and triplets tend to be born at earlier gestational ages, the authors note.
    • “Gestational age is a strong predictor of short- and long-term morbidity and early mortality,” the authors write. “Births delivered preterm are at the greatest risk of adverse outcomes, but risk is also elevated for early-term compared with full-term births.”
  • MedCity News points out,
    • “Mayo Clinic has entered into a collaboration with TruLite Health — Mayo is helping the Phoenix-based startup develop its software platform designed to address providers’ clinical bias. The health system said it chose to collaborate with TruLite because of the platform’s potential to mitigate health inequities and enhance patient outcomes at the point of care.”
  • Per Fierce Healthcare,
    • “Artificial intelligence can help identify easy to miss patients who might be good candidates for a palliative or hospice care referral, a recent pilot at Mass General Brigham (MGB) revealed.
    • “The results of the findings were presented Friday at the Value-Based Payment Summit.
    • “Timely end-of-life care benefits patients. Patients and their families may also be more open to a conversation about goals of care during a hospital stay, MGB said in presentation slides shown to Fierce Healthcare.” 

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Holdings, the controlling shareholder of Danish drugmaker Novo Nordisk, will buy contract manufacturer Catalent for $16.5 billion in a take-private deal the companies announced Monday.
    • “In a related transaction, Novo Nordisk has agreed pay its parent company $11 billion to take over three Catalent plants in Italy, Belgium and Indiana to help expand production of its GLP-1 drugs Ozempic and Wegovy. Demand for the latter, which is approved in the U.S. for treating obesity, has greatly exceeded supply, forcing Novo Nordisk to restrict access.
    • “Novo Nordisk and Catalent already work together at the three sites, which employ more than 3,000 staff.”
  • and
    • “On Monday, Johnson & Johnson said one of its most closely watched experimental medicines appears to have positive effects on two autoimmune diseases, providing further support to a drug that, by the company’s estimates, could eventually generate billions of dollars in annual sales.
    • “J&J didn’t release any data, but rather said the drug hit the main goals of a mid-stage clinical trial testing it in patients with Sjögren’s disease as well as a late-stage study focused on generalized myasthenia gravis, a rare condition known in short as gMG. The company plans to present more detailed results from both studies at upcoming medical meetings, and to engage with regulators about the path to approval in gMG.”
  • Per Healthcare Dive,
    • “Cano Health filed for Chapter 11 bankruptcy late Sunday, as the beleaguered primary care chain works to bolster its financials. 
    • “The filing is part of a restructuring support agreement with the majority of its lenders. Cano said it expects to emerge from restructuring during the second quarter this year, adding that the process will help it reduce debt and allow it to search for a strategic partner or buyer.
    • “Cano also announced it reached an agreement to receive $150 million in debtor-in-possession financing to fund its operations during restructuring.”
  • and
    • “Medicare Advantage rate changes proposed by regulators last week are upsetting Humana’s funding expectations for 2025.
    • “If finalized as proposed, the MA changes will lower Humana’s benchmark funding by around 160 basis points compared to a flat rate environment, the health insurer disclosed in a filing with the Securities and Exchange Commissionon Monday.
    • “The discrepancy is because the CMS didn’t factor in persistently elevated medical costs into how it calculates rates, Humana said. However, regulators could do so in the final rule. Despite the uncertainty, the insurer reaffirmed its earnings outlook for 2025.”
  • Per Fierce Healthcare,
    • “Rural providers feel financially stable, with most planning to expand existing service lines to increase revenue, a new survey has found (PDF).
    • “The survey was conducted by accounting firm Wipfli and reached 106 rural healthcare organizations across 26 states. Respondents included a mix of critical access hospitals, rural health clinics and others.
    • “Overall, most respondents are cautiously or completely optimistic about their financial viability. About 40% said their financial stability is higher than it was a year ago, and the portion of those who think they are in a better place than they were five years ago also rose compared to 2023. Despite challenges like high inflation, dwindling COVID-19 relief funds and flat reimbursement rates, growing optimism suggests rural providers learned how to manage unpredictability during the pandemic, the report said. * * *
    • Entering 2024, rural healthcare leaders are most concerned about revenue capture, digital capabilities and people management.
  • HR Morning offers nine tips on maximizing core health benefits.
  • The Society for Human Resource Management discusses best practices for hybrid work models.

Weekend Update

David Ermer–Congress, Federal employment benefits, Government Contracting, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The House of Representatives and the Senate continue to engage in Committee business and floor voting this week. The Committee for a Responsible Federal Budget reminds us
    • “The [current continuing resolution (CR)] measure extends the “laddered” approach from the previous CR, with the first set of appropriations bills expiring on Friday, March 1: Agriculture, Energy-Water, Military Construction-VA, and Transportation-HUD (these were previously set to expire Jan. 19). The second set of appropriations bills would expire a week later, on Friday, March 8: Commerce-Justice-Science, Defense, Financial Services-General Government, Homeland Security, Interior-Environment, Labor-HHS-Education, Legislative Branch, and State-Foreign Operations bills (these were previously set to expire Feb. 2).”
  • On February 1, The Government Accountability Office
    • “issue[d] a new revision of the Generally Accepted Government Auditing Standards, also known as the “Yellow Book,” which supersedes the 2018 revision of the standards. The Yellow Book is the book of standards and guidance for government auditing—outlining the requirements that make for effective, quality audits when reviewing government programs and spending. It’s used by our federal government auditors here at GAO, as well as federal, state and local auditors; inspectors general; and auditors of entities that receive government awards. 
  • The February 1 WatchBlog post takes a closer look at this important guidance and GAO’s updates.
  • Independent auditors base their audits of experience rated FEHB plans on the Yellow Book and related OPM guidance.
  • Last Tuesday, the Accreditation Association for Ambulatory Healthcare (AAAHC) released its updated FEHB Accreditation Handbook. Employee organization plans in the FEHB Program are accredited by AAAHC.
  • Reg Jones, writing in FedWeek, offers primers on annual leave and sick leave for federal and postal employees.

From the public health front,

  • The Wall Street Journal reports,
    • “Medical centers are starting programs to identify patients’ chances of cognitive decline and recommend ways to delay or prevent it. Most patients are in their 40s to 60s; some clinics take patients as young as 18. Insurance covers some services, otherwise tests and visits can range from hundreds to thousands of dollars.
    • “Doctors in these clinics counsel patients to make personalized lifestyle changes, such as building resistance training into workouts or eating more leafy greens. They also recommend medications to treat conditions linked to Alzheimer’s risk, such as statins for high cholesterol. There’s no guarantee of preventing the disease or other forms of dementia, however, and some doctors are skeptical of these programs. * * *
    • “If every primary-care doctor in every primary-care practice did prevention well, then this program may not need to exist,” says Dr. Zaldy Tan, who heads the new Memory & Healthy Aging Program at Cedars-Sinai. “But we know that that doesn’t happen.” 
  • MedTech Dive tells us,
    • Medical devices patients can use at home, such as infusion pumps and ventilators, are the top health technology hazard of 2024, a nonprofit patient safety organization said Wednesday.
    • ECRI named at-home devices as the top hazard in response to examples of harms such as medication errors with the use of infusion pumps that suggest products “may be too complex for laypeople to use safely and effectively.”
    • The group identified inadequate or onerous device cleaning instructions as the second biggest hazard of the year, reflecting evidence that reprocessing failures can spread infections.

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing.
    • “The fund, which would be Arch’s 13th, is being put together less than two years after the firm closed a similar-sized $3 billion raise that was its largest to date. Plans were outlined in a filing Arch made this week with the Securities and Exchange Commission. The form was signed by Arch managing director and CFO Mark McDonnell.
    • “Arch declined to comment on the filing.”
  • The New York Times reports
    • “A sharp shift in health care [spending?] is taking place as more than one-third of American adults now supplement or substitute mainstream medical care with acupuncture, meditation, yoga and other therapies long considered alternative.
    • “In 2022, 37 percent of adult pain patients used nontraditional medical care, a marked rise from 19 percent in 2002, according to research published this week in JAMA. The change has been propelled by growing insurance reimbursement for clinical alternatives, more scientific evidence of their effectiveness and an increasing acceptance among patients.
    • “It’s become part of the culture of the United States,” said Richard Nahin, the paper’s lead author and an epidemiologist at the National Center of Complementary and Integrative Health, a division of the National Institutes of Health. “We’re talking about the use for general wellness, stress management use, sleep, energy, immune health.”
    • “And for pain management. The use of yoga to manage pain rose to 29 percent in 2022 from 11 percent in 2002, an increase that Dr. Nahin said reflected in part efforts by patients to find alternatives to opiates, and the influence of media and social media.”
  • Fortune Well adds,
    • “According to the Global Wellness Summit’s 2024 trends report from the Global Wellness Institute, which combines research and insights from experts in the field—including scientists, CEOs, and academics—the wellness market is surging. And it’s not expected to slow down anytime soon. 
    • “The U.S. tops the global list of countries for spending on wellness, amassing an annual market of $1.8 trillion, up 14% since 2020. On average, people in the U.S. spend $5,321 per year on wellness, coming in 5th behind the Seychelles, Switzerland, Iceland, and Aruba.”         

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Mental health care, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Federal News Network informs us
    • “Agencies don’t have to worry about a 1% sequestration on discretionary funds kicking in for a few more months.
    • “The Office of Management and Budget says the requirement to reduce discretionary spending under the Fiscal Responsibility Act (FRA), signed into law in June, wouldn’t take effect until “after full year appropriations are enacted, or April 30, whichever comes first.”
    • “OMB will take no action on Jan. 1, 2024, and no additional action should be taken by agencies to reduce impacted discretionary funding, even though a short-term continuing resolution will be in effect at that time,” OMB wrote in frequently asked questions on 2024 discretionary spending sent to agencies on Dec. 22. “If any discretionary appropriation account remains on a short-term CR past April 30, OMB is required to issue a final sequestration report that compares the annualized appropriation levels provided by all discretionary appropriations bills under current law as of April 30 against the [FRA’s] section 102 interim spending limits. A breach of the section 102 spending limits would require OMB to order a sequestration to bring the current law discretionary appropriations in line with those interim spending limits.”
  • Govexec identifies the federal agencies with the greatest increases and decreases in employee morale in 2023 according to OPM’s 2023 Federal Employee Viewpoint Survey.
  • Fedweek offers a summary of OPM’s current regulatory activities.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Immune-boosting drugs have revolutionized cancer care. Now doctors are experimenting with cutting them off.  
    • “Immunotherapies unleash the immune system on tumors. They have extended the lives of people with melanoma, lung and bladder cancers. They have also been a boon for drugmakers, generating global sales of $44 billion in 2022, according to Leerink Partners analysts. 
    • “But some patients are getting more of the drugs than they need, exposing them to side effects and costs they could avoid without risking their cancer recurring. Preliminary research suggests taking the drugs at a lower dose or for a shorter period could be sufficient, but drugmakers haven’t funded the studies needed to confirm the findings. 
    • “We don’t know when to stop,” said Dr. Jedd Wolchok, an oncologist focused on melanoma at Weill Cornell Medicine in New York. * * *
    • “Recalibrating care toward less treatment is a fraught undertaking. Drug companies won’t fund studies exploring whether patients can do as well with less of their products, doctors said. Some doctors and patients worry about pulling back before exhausting their best chance to beat the disease.
    • “There was this dogma that more is better,” said Dr. Mark Ratain, an oncologist at the University of Chicago. 
    • “He is trying to recruit cancer patients to study whether they could do as well with less of Merck’s Keytruda or Bristol-Myers Squibb’s Opdivo, so-called immune checkpoint inhibitors. After three years, he has found just 60 of the 260 patients he wants, and most medical centers have declined to join the trial. “It was going to be difficult to convince people,” he said.”
  • Beckers Payer Issues interviews Kofi Essel, MD, Elevance Health’s first food as medicine program director. Dr Essel “sat down with Becker’s to discuss how Elevance is building a food as medicine strategy intended to eventually touch and improve the lives of its more than 47 million members nationwide.” Check it out.
  • MedPage Today tells us,
    • “The 988 lifeline routes callers to a network of more than 200 state and local call centers that are financially supported by the Substance Abuse and Mental Health Services Administration (SAMHSA), as well as state and local governments. In its first year, according to a July press release from SAMHSA, the lifeline answered nearly 5 million calls, texts, and chats from people looking for help with suicide, mental health, and substance use-related crises; that’s 2 million more contacts than the lifeline received in the previous 12 months, when it was a 10-digit phone number. (That 10-digit number — 800-273-8255 — is still in operation.)
    • “So far, 1.5 years in, things seem to be going well overall, said Michele Gilbert, MPH, senior policy analyst at the Bipartisan Policy Center in Washington, D.C. “Luckily, the implementation of 988 has seen some real success,” Gilbert said in a phone interview. “A lot of the operations have gone relatively smoothly.”
    • “Debbie Plotnick, MSS, executive vice president for state and federal advocacy for Mental Health America, agreed. “We have seen tremendous increases in the number of people who call, and even more importantly, what has improved dramatically is the wait time to speak to an actual human being,” she told MedPage Today. “Going back a couple of years, it could have been up to, like, 2 minutes, and now it’s within 30 or 40 seconds that you are actually connected to a live human being.”
    • “That decrease in wait time may not sound like a lot, but it’s actually “huge,” Plotnick said. “If you’re at the point where you’re going to hurt yourself and you don’t know if anybody in the world cares, 2 minutes can really feel like an eternity. But now calls are being answered very quickly.” She also praised the lifeline’s addition of text and chat options, as well as special lines for veterans, for Spanish speakers, and for LGBTQ+ callers.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • “The median hospital operating margin rose to 2% in November after holding steady at 1.6% in September and October, but escalating expenses — including rising drug costs — remain a concern as 2023 draws to a close, according to a Dec. 21 report from Syntellis Performance Solutions, which includes data from more than 1,300 hospitals.
    • “U.S. hospitals began the year with a median operating margin of -0.9%, but that figure has steadily increased and looks set to end the year at a healthier level around the 2% mark in December. November was the ninth consecutive month of positive operating margins. 
    • “While the median hospital margin remains far below pre-pandemic levels, it has shown significant progress in recent months as hospitals continue their recovery after more than a year of negative results. 
  • The Wall Street Journal reports,
    • “Drug company Bristol-Myers Squibb struck a $4.1 billion deal to buy  RayzeBio in a bet on a re-emerging cancer drug technology.
    • “RayzeBio develops radiopharmaceutical drugs, which use targeted forms of radiation that are delivered directly to cancer cells. Earlier products using the technology struggled commercially, but further research led to another wave of promising therapies that can attack tumors while limiting damage to surrounding healthy cells.  * * *
    • “Bristol said the RayzeBio deal is slated to close in the first half of 2024.”
  • and
    • AstraZeneca has agreed to buy Gracell Biotechnologies for a transaction value of $1.2 billion, as part of the former’s efforts to grow its cell therapies business.
    • The acquisition will help grow AstraZeneca’s pipeline of cell therapies for potential treatment of cancer and autoimmune diseases.
    • The transaction is expected to close in the first quarter of next year, AstraZeneca said. 

Monday Roundup

David Ermer–CMS, Congress, Medical / Rx research, Medicare, OPM, Patient safety, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Bloomberg reports,
    • “House lawmakers worked over the weekend on a stopgap measure needed to fund the US government beyond a Nov. 17 deadline, Speaker Mike Johnson said.
    • “While Johnson didn’t mention the proposed length of the extension in a Fox News Sunday interview, he has floated a Jan. 15 timeline since being elected speaker in October.
    • “The extension “would allow us time” to continue the appropriations process, which involves bringing 12 spending bills to the House floor for passage, the Louisiana Republican said.”
  • The FEHBlog watched the House Rules Committee pass a rule on the financial services and general government appropriations bill (HR 4664), which means that the bill will be brought to the House floor this week.
  • From the other side of Capitol Hill,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released the Chairman’s Mark of a legislative package to expand mental health care and substance use disorder services under Medicaid and Medicare, reduce prescription drug costs for seniors at the pharmacy counter, extend essential Medicaid and Medicare provisions that will expire this year, and increase Medicare payments to support physicians and other providers.
    • “The Committee will hold a markup on the legislation on Wednesday, November 8, at 10 a.m.
    • “The Chairman’s Mark can be found here. A section by section can be found here. A CBO analysis can be found here.
    • “Amendments and additional information will be posted here on Tuesday, November 7, after 12 p.m.”
  • The U.S. Office of Personnel Management announced,
    • “The U.S. Office of Personnel Management (OPM) released governmentwide results of the 2023 OPM Federal Employee Viewpoint Survey (FEVS) today. The OPM FEVS is the largest annual survey of government employees in the world that tracks how federal employees view their current work environment, including workforce management, policies, and new initiatives. OPM FEVS is an unmatched government data asset that collects employee feedback from more than 80 executive agencies to assist in driving improvement and supporting the workforce to serve the American people.   
    • “This year’s Federal Employee Viewpoint Survey highlights that federal employees remain remarkably resilient, increasingly engaged, and value diversity, equity, inclusion, and accessibility in the workplace,” said Kiran Ahuja, Director of the Office of Personnel Management. “These encouraging results provide opportunities for agencies to build momentum and support their workforce to leverage workplace flexibilities, continue advancing DEIA, and remain motivated to continue delivering for the American people.”  
  • The Centers for Medicare and Medicaid Services proposed a new Medicare Advantage Program rule that covers multiple topics.
  • Health Payer Intelligence adds,
    • “Medicare Advantage beneficiaries experience higher quality care and better health outcomes than fee-for-service beneficiaries, according to a report from Harvard and Inovalon.
    • “Researchers used Inovalon’s claims data to assess care quality for people enrolled in Medicare Advantage and those with Medicare fee-for-service between 2015 and 2019.”
  • Healthcare Dive reports,
    • “Healthcare employment growth fell across the board during the COVID-19 pandemic. Some sectors have had more difficulty rebounding than others, according to a new study — especially skilled nursing facilities, which face a controversial federal push for more staffing.
    • “Employment in hospitals increased 0.4% per quarter before the pandemic, but that growth rate shrunk to 0.03% during COVID-19, according to the study published in JAMA. By comparison, employment at skilled nursing facilities was already declining before COVID, dropping at a rate of 0.2% per quarter. During the pandemic, the rate of job losses accelerated to 1.1%.
    • “The Biden administration is seeking to impose mandatory nursing staffing minimums at skilled nursing facilities, or SNFs. The nursing home industry largely opposes the rule, arguing there are not enough workers available to meet the staffing mandate.” 

From the public health and research front,

  • The FEHBlog took the RSV vaccine today. The pharmacist who administered the injection told him the RSV vaccine are expected to be a once-every-decade experience for adults like the Tdap vaccine.
  • American Hospital News informs us,
    • “The more than 11,000 patients who received care during the first 16 months of the Acute Hospital Care at Home initiative had a low mortality rate and minimal complications related to escalations back to the brick-and-mortar hospital, according to a study reported Friday in JAMA Health Forum. CMS launched the initiative in November 2021 to address the COVID-19 public health emergency and concerns about hospital bed capacity. The Consolidated Appropriations Act of 2023 extended the CMS initiative through December 2024.
    • “The law also requires hospitals to provide additional data to CMS to monitor the quality of care, and for CMS to undertake a comprehensive study of the AHCAH initiative by September 30, 2024,” the authors note. “This study, data review, and additional monitoring will be important for identifying best practices that support safe and effective inpatient-level care delivered in the home environment.”
  • Per Fierce Healthcare,
    • “U.S. hospitals made gains to reduce healthcare-acquired infections (HAIs) but saw patient experiences further deteriorate in the latest release of an independent watchdog’s twice-yearly safety report.
    • “According to The Leapfrog Group, the sector has significantly reduced the incidences of Methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs) after reaching five-year highs during the COVID-19 pandemic.
    • “Specifically, 66% of the almost 3,000 general hospitals polled by the group improved their performance on at least one of the three HAIs. Nineteen percent improved across all three of the infection measures, while 16% either worsened or made no improvement.
    • “Now that we have pre- and post-pandemic data for patient safety measures, we are encouraged by the improvement in infections and applaud hospitals for reversing the disturbing infection spike we saw during the pandemic,” Leah Binder, president and CEO of The Leapfrog Group, said in a release.”
  • Here is a link to the Leapfrog Group report.
  • Beckers Hospital Review adds, “A comparison of data from CMS and The Leapfrog Group suggests that a hospital’s strong performance in one national quality rating system does not necessarily mean it will be a top performer in another.”
  • The New York Times Magazine gives us a story about the use of bariatric surgery on teenagers.

From the U.S. healthcare business front,

  • Reuters reports,
    • “Cigna is working with an investment bank to evaluate options for its Medicare Advantage business, which could fetch several billions of dollars in a potential divestment, the sources said.
    • “The discussions with interested parties, including other companies and private equity firms, are at an early stage, and Cigna may decide to keep the business, the sources added, requesting anonymity because the matter is confidential.”
  • Per Beckers Hospital Review,
    • “Oakland, Calif.-based Kaiser Permanente reported $156 million in operating income (0.6% margin) for the third quarter, up from a $75 million operating loss (-0.3% margin) in the third quarter of 2022. 
    • “For the three months ended Sept. 30, Kaiser’s health plan, hospitals and their respective subsidiaries posted $24.9 billion in revenue and $24.7 billion in expenses, compared to $24.3 billion and $24.3 billion, respectively, in the same period of the prior year. 
    • “Net income for the third quarter was $239 million, up from a net loss of $1.5 billion in the third quarter of 2022.”
  • and
    • “As operating margins inch upward, hospitals are trending to profitability. But their performance still isn’t at pre-pandemic levels. 
    • “For the first three quarters of 2023, hospital operating margins were up 19% and operating EBIDA was up 11% compared to the same period last year, according to Kaufman Hall’s October National Hospital Flash Report. Net operating revenue per calendar day saw a 6% increase and even inpatient revenue was up 3%. Compared to 2020, year-to-date operating margins in September were down 2% and operating EBIDA margins were down 9%.”