Thursday Miscellany

FDA

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–Congress, COVID-19, FDA, Medical / Rx research, Medicare, Obesity, Telehealth, U.S. Healthcare–

From Washington DC

Photo by Thought Catalog on Unsplash
  • Fierce Healthcare tells us,
    • “U.S. Senators Sheldon Whitehouse and Bill Cassidy want to reform how primary care providers get paid through Medicare, and they also want to hear from the healthcare industry about the best way to do it.
    • “Whitehouse, a Democrat from Rhode Island, and Cassidy, a physician and Republican from Louisiana, introduced a bipartisan bill, the Pay PCPs Act, S. 4338, on Wednesday to better support and improve pay for high-quality primary care providers. 
    • “The legislation serves as a marker for future primary care legislation and is intended to solicit feedback on a number of important policy questions, the lawmakers said. * * *
    • “Whitehouse and Cassidy also issued a request for information for feedback on policy questions. Feedback can be submitted to physician_payment@cassidy.senate.govuntil July 15, 2024.”
  • Govexec informs us about a mark-up of federal employee telework bills at a Senate Homeland Security and Governmental Affairs committee meeting today.
  • Barrons reports,
    • “Social Security recipients could receive a 3.2% raise next year, according to an estimate based on Wednesday’s inflation result. * * *
    • “The Social Security Administration will announce the actual COLA for 2025 in October, once inflation data from the third quarter are complete. The raise will be equal to the percentage gain in the average level of CPI-W for the third quarter of 2024 from the average for the same period in 2023.
    • “In their annual report, the Medicare Trustees estimated that the standard monthly Part B premium could rise to $185 next year, a 5.9% increase from this year’s $174.70. Part B premiums, which are automatically deducted from Social Security checks, are one of the fast-growing costs in retirement, [independent consultant Mary] Johnson says.
  • Plan Sponsor lets us know,
    • “The ERISA Advisory Council voted during a meeting Wednesday to focus its attention on issues related to welfare plan claims and appeals and qualified default investment alternatives. The council will study these issues and make recommendations to the Employee Benefit Security Administration later this year as per its mandate from the Department of Labor. * * *
    • “Members also considered a review of pension death audit service providers in light of the Central States and Special Financial Assistance controversy in which the Central States pension fund received $127 million in SFA funds for 3,479 dead participants. This error occurred because the plan did not have access to the Social Security death master file and the money was repaid. Since death audit providers also lack access to the DMF, there was concern among some members about how an auditor can certify a death audit at all.”
    • In the FEHBlog’s opinion, it is dumbfounding that pension and health benefit plans are not allowed access to the DMF.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The U.S. saw a slight decline in the number of new overdose deaths last year, marking a rare improvement in a still-raging national fentanyl crisis, preliminary federal data show. 
    • “There were about 107,500 overdose deaths in 2023, down 3% from the year before and the first decline in five years, according to estimates from the Centers for Disease Control and Prevention. One factor was fewer deaths pegged to opioids including the nation’s deadliest drug, the potent synthetic fentanyl, the CDC’s preliminary numbers show. 
    • “It’s the direction we want to be going,” said Mary Sylla, director of overdose prevention policy and strategy at the National Harm Reduction Coalition, which advocates for measures such as easy-to-access medicine to reverse overdoses.
    • “I just hope we can continue the trend, and I hope we double-down on the evidence-based interventions that save peoples’ lives,” Sylla said.”
    • FEHBlog note — Amen to that.
  • The Centers for Disease Control announced,
    • “Approximately 4,000 unintentional drowning deaths occur annually in the United States, and demographic disparities exist.
    • “Compared with unintentional drowning death rates in 2019 (pre–COVID-19 pandemic), rates were significantly higher during 2020, 2021, and 2022, with highest rates among children aged 1–4 years, non-Hispanic American Indian and Alaska Native persons, and non-Hispanic Black or African American persons. National survey data revealed that 55% of U.S. adults have never taken a swimming lesson, and swimming lesson participation differed by demographic characteristics.
    • “The U.S. National Water Safety Action Plan provides recommendations for drowning prevention actions, including increasing access to basic swimming and water safety skills training for all persons, which could reduce disparities in unintentional drowning deaths.”
    • FEHBlog observation — Focus on training children aged 1-4 years.
  • MedPage Today notes,
    • “Patients hospitalized with COVID-19 were more likely to die than those hospitalized with influenza during the fall and winter of 2023-2024, according to an analysis of Veterans Affairs data.
    • “Among over 11,000 patients hospitalized for either illness during this past fall and winter, 5.7% of patients with COVID-19 died within 30 days of admission versus 4.24% of patients with influenza, reported Ziyad Al-Aly, MD, of the VA St. Louis Health Care System, and colleagues.
    • “After adjusting for variables, the risk of death in people hospitalized for COVID-19 was 35% higher (adjusted HR 1.35, 95% CI 1.10-1.66), the authors detailed in a research letter in JAMA.”
  • Cardiovascular Business adds,
    • “Heart failure (HF) patients who received a COVID-19 vaccine are significantly less likely to be hospitalized for HF symptoms or die for any reason, according to new data presented at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC). 
    • “The analysis included data from more than 651,000 adult Korean residents with HF. The average patient age was 69.5 years old, and 50% were men. Approximately 83% of patients were fully vaccinated against COVID-19, meaning they received two or more doses of an approved vaccine. 
    • “The study’s authors compared 73,559 vaccinated patients with 73,559 unvaccinated patients, matching them 1:1 according to age, sex, comorbidities and other relevant patient attributes. The median follow-up period was six months. 
    • “Overall, COVID-19 vaccination was associated with an 82% lower risk of all-cause mortality, 47% lower risk of hospitalization for HF and 13% lower risk of testing positive for COVID-19. Vaccinated patients also had lower rates of stroke, heart attack, myocarditis/pericarditis and venous thromboembolism during that six-month period.”  
  • Beckers Hospital Review points out,
    • “Ozempic, Mounjaro and other GLP-1s do not increase the risk of surgical complications, according to research published May 14 in Diabetes, Obesity and Metabolism. 
    • “Nearly a year after the American Society of Anesthesiologists recommended patients skip a dose of their GLP-1s — which are medications approved for Type 2 diabetes and weight loss — because of regurgitation and aspiration risks, a review of 130 million patient records found no increased risk. 
    • “GLP-1s can delay gastric emptying, which can minimize the effect of normal fasting rules before elective surgeries. Soon after the ASA published the guidance, surgery departments across the U.S. updated their preoperative care processes to align with the guideline.” 
  • The Washington Post reports,
    • “The Food and Drug Administration this week moved to expand screening for potentially lethal cervical cancer by allowing women to collect test samples themselves, a move that reproductive health advocates view as crucial to stamping out the preventable disease.
    • “For the first time, women will be able to gather samples for testing in private rooms inside offices of primary-care doctors, at urgent-care clinics and even pharmacies — an advance that could presage home testing.
    • “Advocates hope the method will make it easier for women of color and those living in rural and underserved communities to screen for human papillomavirus — HPV — which can lead to a cancer that afflicts 11,000 each year. It comes as the National Cancer Institute has ramped up study of self-collection, partnering with 25 medical schools and cancer centers across the country to gauge use of collecting vaginal samples at home and at health-care facilities. * * *
    • “The collection method was greenlit for the previously approved HPV test Onclarity, manufactured by BD (Becton, Dickinson and Company). The test is expected to be available in summer and will be part of a study of self-collection, the company said in a news release Wednesday.
    • “Roche also received sign off for the self-collection method for its cobas HPV Test, and has been collaborating with the NCI’s study, the company said in a news release. * * *
    • “This literally just opens up another option for a different demographic of people that might not feel comfortable, that might not have access [and] may not have time” to get tested otherwise, said Irene O. Aninye, chief science officer for the Society for Women’s Health Research, a group focused on advancing women’s health and promoting research.”
  • STAT News relates,
    • “Eisai and Biogen said today that they’ve filed an application with the FDA to sell their Alzheimer’s drug Leqembi through an autoinjector for maintenance dosing. That means patients would first go through an initiation phase with the current regimen of IV infusions, but then transition into weekly injections for maintenance.
    • “If approved, this would be a significantly more convenient option for patients, since infusions require patients once every two weeks to travel to a medical facility and receive the infusion for an hour.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Chicago-based CommonSpirit is pushing for change in the dynamics of payer-provider relationships and is “taking a firm stance on contract renewals so payers absorb a share of inflation,” management said in financial documents published May 15. 
    • “The 142-hospital system said one of the most critical levers for health systems to maintain financial stability is to receive the revenue and cash flow they are entitled to for services provided. 
    • “The news comes shortly after CommonSpirit split with Anthem Blue Cross Blue Shield of Colorado. The breakup, which affects commercial and Medicare Advantage members, means 11 of CommonSpirit’s hospitals and more than 40,000 of its patients in the state are now out of network with the insurer. 
    • “It was never our intent to leave the Anthem Blue Cross Blue Shield network, only to work together in good faith toward a balanced agreement,” CommonSpirit said in a statement on its website. 
    • “The system said that it is willing to continue working toward a new agreement with Anthem but its previous proposals “failed to offer terms that fairly reimburse for services provided to its members, and equitably cover the burden to get reimbursed timely and accurately.”
  • Per Fierce Healthcare,
    • “Uber Health will begin rolling out a new solution designed for caregivers this summer, the company announced at its annual product event Wednesday. 
    • “Uber Caregiver will allow individuals to add a caregiver to their Uber profile. That caregiver can then see and spend that person’s health benefits on eligible services, request rides to doctors’ appointments or order groceries. The caregiver will get real-time updates along the way and have access to a chat feature to communicate with the Uber driver as needed.
    • “Individuals will need to use the Uber app to participate. Uber also offers a way for those who need help to request a ride by calling 1-833-USE-UBER from a phone with texting capabilities. The phone line also supports some health benefits cards.”
  • and
    • “Digital maternal health company Babyscripts announced a partnership Tuesday with Lyft Healthcare to offer sponsored rides for people who are pregnant or postpartum and face barriers to transportation.
    • “Though Babyscripts is a digital-first, tele-maternal health company, it acknowledges that pregnant individuals also need in-person care. 
    • “Access is one of the biggest challenges to maternal health and infant health—and a patient’s outcomes can come down to whether or not they go to their doctor appointments,” Anish Sebastian, CEO and co-founder of Babyscripts, said in a statement.”

Tuesday Tidbits

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec lets us know,
    • “The U.S. Postal Service is pausing some of the most controversial reforms to its mailing network as its leadership has agreed to the demands of a growing, bipartisan chorus in Congress. 
    • “The mailing agency has halted its plans to consolidate dozens of processing facilities until at least Jan. 1, 2025, ensuring the network overhaul is paused until after the upcoming presidential election in which millions of Americans will be voting by mail. A large swath of lawmakers across the ideological spectrum have called on Postmaster General Louis DeJoy to delay or cease the changes, some of which would shift the bulk of mail processing across state lines. 
    • “The decision marks a reversal for DeJoy, who just last week remained resolute in defending his vision as the only viable path forward for his agency. He called the issue an existential one, saying his reforms were “what we must continue to do to survive.” 
  • HHS’s Agency for Healthcare Research and Quality posted its March 2024 “NATIONAL HEALTHCARE QUALITY AND DISPARITIES REPORT CHARTBOOK ON PATIENT SAFETY.”
  • Per an FDA press release, “[o]n Monday [May 13], the FDA issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to an increased risk of false results. The FDA had also issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “The coronavirus has once again evolved, in a familiar echo of past years. Unlike earlier iterations of the virus, this new variant is not sparking widespread havoc.
    • “The Centers for Disease Control and Prevention said it is monitoring a variant called KP.2 and does not see evidence it causes more severe illness than other strains. Laboratory tests have shown that KP.2 is not causing a surge in infections or transmission, the agency said.
    • “The CDC has identified a second emergent variant, KP.1.1. But it is KP.2 that is leading the pack. Both new variants belong to a group of coronavirus variants dubbed “FLiRT” by scientists. The acronym was coined to describe a combination of mutations found in the spike protein of the SARS-CoV-2 virus. * * *
    • “KP.2 has symptoms similar to earlier versions of the virus, including fever, chills, cough and muscle or body aches.”
    • The current vaccines are effective against KP.2. [“H]ealth experts predict that the new formulation of the coronavirus expected for the fall could offer even stronger protection because it will probably be tailored to thwart the new variant.”
  • Beckers Hospital News informs us,
    • “On average, people taking Novo Nordisk’s weight loss drug Wegovy see a 10% reduction in weight, which is sustained for four years, according to findings from a major trial published May 13.  * * *
    • “Wegovy is tied to a 20% reduced risk of heart attacks and other cardiovascular events — a benefit that was seen across the board, irrespective of how much weight people lost.” 
  • STAT News adds,
    • “Novo Nordisk will test whether its GLP-1 drugs can help people with alcohol-associated liver disease, and, as part of that, will study if the treatments will change the amount of alcohol people drink.
    • “This appears to be the first time the company is getting involved in research to see if the booming class of GLP-1 diabetes and obesity drugs can affect substance consumption, a question that academic researchers have been probing but the pharmaceutical industry has so far avoided.
    • “The nine-month study will try three drugs alone and in combinations against placebo. The primary outcome being tested is change in liver scarring, or fibrosis, and one of the secondary outcomes is changes in alcohol consumption. The news of the study was first reported by Bloomberg.
    • “The medications that will be tested include the blockbuster semaglutide, sold as the diabetes drug Ozempic and obesity drug Wegovy, as well as CagriSema, a drug Novo is developing that combines semaglutide with the dual amylin and calcitonin receptor agonist cagrilintide. A third drug, NNC0194-0499, targets FGF-21, a hormone produced by the liver that plays a role in inflammation.”
  • NIH’s All of Us Program posted its latest newsletter.
  • Per an Institute for Clinical and Economic Research press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD). * * *
    • “Key Clinical Findings
    • “Although ICER attempted to explore the concerns raised about MDMA-AP and the MAPP trials, ICER was not able to assess the extent that bias influenced reporting of benefits or the frequency with which there may have been misreporting of harms. As such, ICER concluded that the current publicly available evidence is insufficient (“I”) to assess the overall net benefit of MDMA-AP. 
    • “Key Cost-Effectiveness Findings
    • “Given the “I” rating, the economic analyses of MDMA-AP in this Evidence Report are only exploratory analyses that provide insights into costs and benefits if it is assumed that the results of the MAPP trials are accurate. ICER did not calculate a health-benefit price benchmark for MDMA-AP.”
  • Benefitfocus released an “Employee Benefits Strategy Playbook for Mental Healthcare.

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “The majority of the nation’s leading for-profit hospital systems by revenue reported net gains during the first quarter led by stronger than expected inpatient volumes.
    • “The boost in inpatient volumes and associated revenue comes just a quarter after providers said they would be betting more heavily on outpatient services to drive growth. 
    • “Increases in inpatient revenues is an area to watch as providers weigh whether and how to adjust their portfolios. Community Health Systems, for example, has been on a selling spree recently in an attempt to deleverage its balance sheets, while HCA Healthcare, Tenet Healthcare and Universal Health Services are expanding services in key markets. 
    • “Should inpatient care utilization continue to rise over multiple quarters, it could influence hospitals’ capital spending, according to research notes from analysts.”
  • BioPharma Dive tells us,
    • “Biosimilars are gaining ground. The IRA could push them further next year.
    • “As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.”
  • Modern Healthcare reports,
    • Behavioral health provider Talkspace rolled out services Tuesday to 13 million Medicare members across 11 states and will expand to 33 million members nationwide by the end of the year.
    • Talkspace services are available to those with traditional Medicare in California, Florida, New York, Ohio, New Jersey, Virginia, Missouri, Maryland, South Carolina, New Mexico and Idaho. The company plans to offer services to Medicare Advantage members later on, as well.

Friday Factoids

David Ermer–CDC, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Govexec reports,
    • “In the face of mounting pressure from lawmakers of all political stripes, watchdogs, stakeholders and even members of its own governing board, as well as another financial quarter in the red, leadership of the U.S. Postal Service is doubling down on its controversial plan to overhaul the agency. 
    • “USPS posted a net loss of $1.5 billion in the second quarter of fiscal 2024, though management noted that was trimmed to a $300 million loss after dispensing with costs outside of its control. USPS leaders boasted they have turned a $200 million profit in the first half of the fiscal year using that same metric, which marked a $600 million turnaround compared to the first six months of fiscal 2023.
    • “While First-Class mail volume has continued its longstanding decline, revenue grew in the quarter by nearly $500 million due in large part to the dramatic price increases USPS has instituted. The Postal Service has cut $100 million in costs, driven largely by a reduction in transportation expenses and slashing 9 million work hours. 
    • “On-time delivery of mail, however, has plummeted as USPS has instituted significant reforms to its network as laid out in Postmaster General Louis DeJoy’s 10-year Delivering for America plan.” 
  • HHS posted a fact sheet on new government efforts to reduce the impact of spread of avian flu H5N1
  • Senators John Fetterman (D PA) and Tina Smith (D MN) announced a bill, “the United States Senate Commission on Mental Health Act of 2024. The bill would establish a U.S. Senate Commission on Mental Health tasked with providing Congress and the president independent, expert policy recommendations to improve access to and affordability of mental health care services. * * * Full text of the bill can be found here.“

From the public health and medical research front,

  • The Centers for Disease Control tells us today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, influenza and RSV test positivity decreased compared to the previous week. COVID-19 test positivity remained stable at low levels.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”
  • STAT News reports “Harvard scientists unveil the most detailed map of the brain ever: ‘It’s an alien world inside your own head’”.
    • “On Thursday, [Dr. Jeffrey’ Lichtman and his partners unveiled the results of their [decade long] efforts in the prestigious journal Science, and also posted to the internet renderings of the human brain unlike any ever seen. They came complete with a program that allows viewers to move through a microscopic alien landscape so detailed Lichtman can’t resist waxing poetic when he talks about it.
    • “It’s an alien world inside your own head,” he said. “Neurons themselves are truly awe inspiringly beautiful. There’s no two ways about it.”
    • “True, the insights gleaned from the tiny sample have not yet unraveled the mysteries of autism, schizophrenia, or depression. They can’t yet explain the mechanics of human learning, memory, and personality on the cellular level. But they represent an important first step in that direction, and provide a tantalizing preview of the kind of insights we might see in the decades ahead.”
  • The Wall Street Journal reports,
    • “Bristol Myers Squibb said on Friday that its trial evaluating a combination of cancer treatments failed to meet its primary endpoint.
    • “The company’s trial was evaluating the cancer-drug Opdivo and concurrent chemoradiotherapy, followed by Opdivo plus Yervoy, the brand name for a monoclonal antibody, in treating unresectable, locally advanced non-small cell lung cancer. The trial’s primary endpoint was progression-free survival.
    • “Bristol Myers Squibb said it would fully evaluate the data and work with investigators to share results with the scientific community.
    • “Opdivo and certain combinations with Opdivo are approved treatments for eligible patients with non-small cell lung cancer.”
  • Per Fierce Healthcare,
    • “Cancer diagnoses are on the rise among younger adults, and a new guidebook seeks to arm employers with the tools necessary to tackle this issue.
    • “The Northeast Business Group on Health’s new toolkit highlights actions employers can take to proactively address growing rates for five types of cancer in their workforce: breast cancer, colorectal cancer, head and neck cancer, cancer of the reproductive organs and skin cancer.
    • “There’s a clear business case for putting a focus on cancer, as the cost of therapies continues to increase and patients often require treatment for the long haul, NEBGH Medical Director Mark Cunningham-Hill, M.D., told Fierce Healthcare.
    • “He said that many employers, especially larger firms, have established sophisticated and comprehensive wellness and health programs for their workers. But they can do more to “connect the dots” between those offerings and critical preventive care around cancer and conditions that increase risk factors, like obesity.”
  • USA Data relates,
    • One out of every 42 babies born in the United States in 2021 was conceived using IVF or other assisted reproductive technologies.  
    • Parents who started treatments in 2021 gave birth to 97,128 babies, a 49% increase from 2012. In 2021, 238,126 patients initiated 413,776 IVF or similar treatment cycles, up 135% from 2012. 
    • IVF was most common in Washington, DC, with 5.8% of babies conceived via IVF, Massachusetts (5.4%), and New Jersey (5.0%). Less than one percent of infants born in Puerto Rico were conceived via IVF (0.4%). Alabama (0.6%) and Arkansas (0.7%) also had low rates.  

From the U.S. healthcare business front,

  • The Kaiser Family Foundation released a “KFF Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs.” Here are the key finding from the poll:
    • “The latest KFF Health Tracking Poll finds that about one in eight adults (12%) say they have ever taken a GLP-1 agonist – an increasingly popular class of prescription drugs used for weight loss and to treat diabetes or prevent heart attacks or strokes for adults with heart disease – including 6% who say they are currently taking such a drug. The share who report ever taking these drugs rises to four in ten (43%) among adults who have been told by a doctor that they have diabetes, a quarter who have been told they have heart disease, and one in five (22%) who have been told by a doctor that they are overweight or obese in the past five years1. Public awareness of GLP-1 drugs has increased in the past year, with about one-third (32%) of adults now saying they have heard “a lot” about these drugs, up from 19% in July 2023.
    • “Most adults who have taken GLP-1 drugs say they took them to treat a chronic condition including diabetes or heart disease (62%), while about four in ten say they took them primarily to lose weight.
    • “About half (54%) of all adults who have taken GLP-1 drugs say it was difficult to afford the cost, including one in five (22%) who say it was “very difficult.” While most insured adults who have taken these drugs say their insurance covered at least part of the cost, even among insured adults about half (53%) say the cost was difficult to afford2.
    • “While 8% of adults ages 65 and older say they have taken a GLP-1 medication for a chronic condition, just 1% say they have ever taken a GLP-1 drug to lose weight, which may reflect Medicare’s lack of coverage for prescription drugs used for weight loss. Nearly four in ten (37%) adults ages 65 and older report being told by a doctor they are overweight or obese in the past five years.
    • “With Medicare currently prohibited by law from covering prescription drugs used for weight loss, six in ten adults say they think Medicare should cover the cost of these drugs when prescribed for weight loss for people who are overweight, including more than half of Democrats, independents and Republicans. Similar shares of the public continue to support Medicare coverage of these drugs for weight loss even after hearing arguments for and against this proposal.”
  • Per BioPharma Dive,
    • “Sanofi will pay vaccine maker Novavax $500 million and take a small equity stake in the Maryland-based company as part of a broad COVID-19 shot alliance, the companies announced Friday.
    • “Through the deal, Sanofi will gain rights to co-market Novavax’s protein-based COVID vaccine globally, excepting certain countries, and a license to combine it with Sanofi’s existing influenza shots. Sanofi will also hold a non-exclusive right to use Novavax’s soap bark tree-derived adjuvant in other products it develops.
    • “Starting next year, Sanofi will book sales of Novavax’s COVID shot and pay Novavax double-digit percentage royalties. The French pharmaceutical company will also support certain R&D, regulatory and commercial expenses.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.”Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.
    • “After updating the app in February, Tandem received 224 injury reports in about two months. The reports related to an issue that caused the app to crash and relaunch, resulting in excessive use of Bluetooth and potentially draining the battery of the connected insulin pump.
    • “The FDA categorized the event as a Class I recall because of the life-threatening potential for pumps to deliver too little insulin. Tandem corrected the fault in an app update in March.”
  • The Wall Street Journal explains why “Getting Alzheimer’s treatment to those who need it poses particular challenges.” For example
    • “The problem isn’t this drug. Sure. It has risks, et cetera,” said Jason Karlawish, co-director, of the Penn Memory Center at the University of Pennsylvania. “But the problem was the drug and the system — namely with a system of care for its delivery.”
    • “Karlawish said his memory center infused its first patient with Leqembi on November 16. He said that in the six months since, the number of patients who have received the drug there has climbed into the double-digits, reaching roughly 50 people. That, he said, required setting up an infrastructure that “either didn’t exist or existed in bits that had to be put together.”
  • MedCity new points out,
    • “Navigation challenges are the top reason consumers stop seeing healthcare providers, while experience issues are the main reason consumers leave their health insurer, a new survey found.
    • “The Accenture report, released last week, surveyed more than 9,700 insured consumers and 8,000 consumers who sought or received care in the prior year. The survey is a follow-up to a 2021 report, which examined why people are loyal or not loyal to their payer or provider.
    • “We wanted to leverage our patient and member experience surveys to continue to track the state of consumerism in health care, assessing how providers and health insurers perform across a number of key touchpoints that drive selection, loyalty, value and ease of use,” said Sarah Sinha, a managing director in Accenture’s health business, in an email.”
  • Insurance Business tells us,
    • “Offering support across a variety of functions including customer service, claims processing, underwriting, and fraud detection, the capability of AI to analyze large datasets and process information will continue to revolutionize insurance.
    • “Nirmal Ranganathan, vice president of engineering, AI, at Rackspace Technology, spoke with Insurance Business on how insurance companies can take advantage of AI to generate cost savings across their businesses.”
    • Check it out.

Midweek Update

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare, Wellness–

From Washington, DC

  • Modern Healthcare tells us,
    • “Congress took the first step Wednesday to extend expiring telehealth rules, hospital at home services and other programs aimed at rural hospitals.
    • “The House Ways and Means Committee passed the Preserving Telehealth, Hospital, and Ambulance Access Act of 2024 by a vote of 31-0, setting it up for passage by the full House later this year. * * *
    • “One potentially controversial provision in the bill requires pharmacy benefit managers that work with Medicare Part D plans to de-link the compensationthey pay themselves from the rebates they secure based on drugs’ high list prices. Rep. Brad Schneider (D-Ill.) said the provision will save the government about $500 million, although official estimates were not yet available. The provision does not apply to the broader commercial market, though Schneider and Rep. Nicole Malliotakis (R-N.Y.) both called for expansion of the provision to the commercial market. Large PBMs oppose such provisions.”
  • Govexec lets us know,
    • “A new report from the Congressional Budget Office found that a gap between the combined pay and benefits of federal workers and their private sector counterparts has nearly disappeared between 2015 and 2022, raising new questions about President Biden’s proposed 2% average pay raise for the federal workforce in 2025.
    • “Federal policymakers generally rely on one of two reports comparing the compensation of federal and private sector workers. First is an annual analysis compiled by the Bureau of Labor Statistics for review by the Federal Salary Council, which compares only the wages of similar jobs, is the preferred citation of Democrats and federal employee unions. * * *
    • “CBO’s analysis, which is typically conducted every five years and is preferred by conservatives, compares “total compensation”—wages plus the cost of benefits like health care, paid leave and retirement—of federal and private sector employees with similar educational backgrounds. This model has traditionally concluded that the cost of federal employees’ pay and benefits is moderately higher than their counterparts in the private sector, although federal workers with master’s or professional degrees still tend to earn less.
    • “The latest version of CBO’s report, which was released last month, covers only 2022, rather than the traditional 2015-2020 period, due to the economic upheaval caused by the COVID-19 pandemic. It found that the total compensation gap between federal and private sector jobs cratered between 2015 and 2022, falling from 17% in its last analysis to just 5%.”
  • Per May 8 HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is announcing the Increasing Organ Transplant Access (IOTA) Model. The proposed model, which would be implemented by the CMS Innovation Center, aims to increase access to kidney transplants for all people living with end-stage renal disease (ESRD), improve the quality of care for people seeking kidney transplants, reduce disparities among individuals undergoing the process to receive a kidney transplant, and increase the efficiency and capability of transplant hospitals selected to participate. This proposed model would build on the Biden-Harris Administration’s priority of improving the kidney transplant system and the collaborative efforts between CMS and the Health Resources and Services Administration (HRSA) to increase organ donation and improve clinical outcomes, system improvement, quality measurement, transparency, and regulatory oversight.” * * *
    • “The proposed rule on the Increasing Organ Transplant Access Model can be accessed from the Federal Register at https://www.federalregister.gov/public-inspection/current. Standard provisions are included in the proposed rule that would be applicable to all Innovation Center model participants that begin participation in a model on or after January 1, 2025.
    • “View – PDF a fact sheet on the Increasing Organ Transplant Access Model.
    • “More information on the Increasing Organ Transplant Access Model is available on the model webpage.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $46.8 million in notices of funding opportunities to promote youth mental health, grow the behavioral health workforce, improve access to culturally competent behavioral care across the country, and strengthen peer recovery and recovery support. President Biden made tackling the mental health crisis and beating the opioid epidemic key pillars in his Unity Agenda for the nation. Today’s announcement will help communities transform how they address behavioral health.”
  • Beckers Clinical Leadership notes,
    • “Starting this summer, rural health clinics seeking Medicare reimbursement can apply through a new accreditation program from The Joint Commission. 
    • “On May 7, The Joint Commission said it has received deeming authority from CMS for a new rural health clinic accreditation program, which is meant to support patient safety improvements by reducing variation and risks in the delivery of primary care and personal health services.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Geneoscopy received Food and Drug Administration approval for its Colosense noninvasive colorectal cancer screening test, the company said Monday.
    • “The stool-based test, which Labcorp will offer, is approved for screening people aged 45 years or older who are at average risk of developing colorectal cancer. The indication puts Geneoscopy in competition with Exact Sciences’ Cologuard test.
    • “Geneoscopy focused on the opportunity in people aged under 50 years in its statement about the approval. Around 2% of people in that cohort used a stool-based test in 2021, but Evercore ISI and TD Cowen analysts expect Colosense to have a limited impact on Exact.”
  • STAT News points out,
    • “The Apple Watch has secured a new qualification from the Food and Drug Administration that could make the smartwatch an appealing tool for medical device companies hoping to illustrate the benefits of a common heart procedure.
    • “Last week, the Apple Watch’s Atrial Fibrillation History feature became the first digital tool qualified under the Medical Device Development Tools (MDDT) program. Released in 2022, the feature estimates a user’s A-fib burden, or how much time they spend in atrial fibrillation, which is an irregular heart rhythm that can cause shortness of breath and fatigue, and is also linked to an increased risk of stroke.
    • “The qualification means that FDA has determined in advance that sponsors can use the feature as a secondary endpoint in clinical trials without having to do additional work. Specifically, the Apple Watch is qualified for use as a secondary endpoint in clinical trials for cardiac ablation devices, which reduce the electrical signals that cause A-fib by scarring the heart with extreme heat or cold energy. Pulsed field ablation is the latest version of the technology, using a controlled electric field to scar tissue rather than the riskier thermal energy.”
  • Regulatory Focus notes,
    • “The US Food and Drug Administration (FDA) is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs, said Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research (CDER).
    • “Cavazzoni made these remarks during a webinar hosted by the Alliance for a Stronger FDA on Monday, during which, she said “we strongly encourage manufacturers not to stop manufacturing as the result of an inspection.” She added that manufacturers sometimes shut down production lines based on what they are hearing during the inspection, which she said could worsen shortages.”

From the public health and medical research front

  •  The Washington Post reports that “Olive oil use [is] associated with lower risk of dying from dementia. An observational study has found that regular olive oil consumption may have cognitive health benefits.”
    • “Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.”Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.
    • “We don’t believe it’s one compound or two. The olive oil has the phenolic antioxidants, which are very important for protecting against oxidative stress,” Vasiliou said. “But there is a lot of other stuff that’s going on there.”
  • Per MedPage Today,
    • “Use of cannabis and nicotine together during pregnancy was associated with higher risks for infant death and maternal and neonatal morbidity compared with no exposure to either substance, with dual-use risk estimates higher than with either substance alone, a retrospective population-based cohort study.
    • “Compared with use of neither substance, the risk of infant death was more than twice as high with combined use in pregnancy after controlling for possible confounders (adjusted risk ratio [aRR] 2.18, 95% CI 1.82-2.62), reported Jamie O. Lo, MD, MCR, of Oregon Health & Science University in Portland, and colleagues.
    • “By comparison, risks were 65% higher with cannabis use only (aRR 1.65, 95% CI 1.41-1.93) and 62% higher with nicotine use only (aRR 1.62, 95% CI 1.45-1.80) versus no exposure, the researchers detailed in JAMA Network Open.
    • “Lo told MedPage Today in an email that she and her colleagues were surprised to see the increased infant death rate in the combined cannabis and nicotine users compared with those using each substance alone.
    • “We also did not expect so many maternal and neonatal/infant outcomes to be worse with combined cannabis/nicotine use,” she added.”
  • The National Cancer Institute posted its periodic cancer information highlights.
  • The National Institutes of Health announced,
    • The National Institutes of Health (NIH) will launch clinical trials to investigate potential treatments for long-term symptoms after COVID-19 infection, including sleep disturbances, exercise intolerance and the worsening of symptoms following physical or mental exertion known as post-exertional malaise (PEM). The mid-stage trials, part of NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, will join six other RECOVER studies currently enrolling participants across the United States testing treatments to address viral persistence, neurological symptoms, including cognitive dysfunction (like brain fog) and autonomic nervous system dysfunction. The new trials will enroll approximately 1,660 people across 50 study sites to investigate potential treatments for some of the most frequent and burdensome symptoms reported by people suffering from long COVID.
    • “People 18 years of age and older who are interested in learning more about these trials can visit trials.RECOVERCovid.org(link is external) or ClinicalTrials.gov and search identifiers NCT06404047, NCT06404060, NCT06404073, NCT06404086, NCT06404099, NCT06404112.” 
  • BioPharma Dive reports,
    • “A profoundly deaf baby who received Regeneron’s experimental gene therapy was able to hear normally within six months, the company announced Wednesday.
    • “The data, presented at a medical conference, build on initially promising research released in October. The baby was dosed at 11 months of age, one of the youngest children in the world to receive gene therapy for genetic deafness, Regeneron said. A second patient, treated at age 4, also showed hearing improvements at a six-week assessment, the company said.
    • “Both children suffer from a type of deafness caused by mutations in a gene known as otoferlin. The initial research on Regeneron’s DB-OTO therapy is part of an ongoing Phase 1/2 trial known as CHORD enrolling infants and children in the U.S., U.K. and Spain.

From the U.S. healthcare business front,

  • MedCity News informs us,
    • “About a third of employers are integrating value-based care into their employer-sponsored insurance, according to a new survey. Another third of employers are determining the “best-fit strategies for their organization” when it comes to accountable care.
    • “The report was published Sunday by the Milken Institute with support from Morgan Health, a JPMorgan Chase healthcare unit for employer-sponsored insurance. The Milken Institute is a nonprofit think tank focused on financial, physical, mental and environmental health. The survey received responses from 72 employers of varying sizes and industry types.
    • “The researchers found that when making health benefit decisions, expanding preventive care, improving access to primary care and focusing on whole-person health are the top three tenets of accountable care. The lowest-ranked tenets are reducing health outcome disparities and increasing access to digital care.”
  • Fierce Healthcare adds,
    • “Employers are in a strong position to lead the charge in changing the conversation around obesity care, according to a new report from the Milken Institute.
    • “The group released a how-to guide employers of all sizes can use to push for obesity to be recognized as a chronic condition, driving a more multifaceted model for care and addressing the stigma that exists around weight.
    • “The guidebook notes that obesity and conditions related to it are having a major impact on healthcare costs, accounting for $425.5 billion in costs for the civilian workforce, according to a recent study. This includes higher medical costs for both employers and employees as well as costs related to absenteeism.
    • “Sarah Wells Kocsis, director of the Center for Public Health at the Milken Institute and one of the paper’s authors, told Fierce Healthcare that employers are starting to take notice of this issue and lead a conversation that’s “decades in the making.”
    • “We’re really at an inflection point,” she said. “Our goal here is to put this in writing and explain what a strong case there is to think about obesity as a chronic disease.”
  • HealthDay explains,
    • “Worries over health-related costs are plaguing the minds of older Americans of all backgrounds, a new poll suggests.
    • “Five of the six health-related issues that most people found very concerning had to do with health care costs, according to results from the University of Michigan National Poll on Healthy Aging. 
    • “And the sixth issue – financial scams and fraud – also had to do with money, results show.
    • “In this election year, these findings offer a striking reminder of how much health care costs matter to older adults,” Dr. John Ayanian, director of the University of Michigan Institute for Healthcare Policy and Innovation, where the poll is based, said in a news release. The poll is supported by AARP and Michigan Medicine, U-M’s academic medical center.
    • “Overall, 56% of people over 50 said they’re concerned about the cost of medical care for older adults, poll results show.”
  • Per mHealth Intelligence,
    • New research reveals that a text message and telephone-based virtual care approach can improve rates of screening, identification, and treatment of maternal mental health conditions.
    • Published in Health Affairs, the study assessed an intervention that addresses various barriers to adopting maternal mental health screening and referral to treatment. Medical University of South Carolina researchers noted that perinatal mental health disorders, perinatal substance use disorders (SUDs), and intimate partner violence are common during pregnancy and the postpartum year. According to data from the Mental Health Leadership Alliance, maternal mental health conditions affect 800,000 families each year in the United States.
  • BioPharma Dive offers a helpful database of patent expiration dates for thirty top-selling medicines.

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.”

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, FDA, Medical / Rx research, NCQA, NIH, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DCm

  • The Wall Street Journal reports,
    • “House Democratic leaders said they would block any effort to remove Speaker Mike Johnson (R., La.), moving to protect the Republican leader from retaliation by his hard-right flank following the passage of a sweeping foreign-aid package that included funding for Ukraine.”
  • This is a smart move because accord to what the FEHBlog has been reading, the Democrats are likely to retake the House of Representatives in the fall election.
  • The Journal also relates,
    • “The Federal Trade Commission is challenging hundreds of pharmaceutical patent listings in an effort to smooth the path to more affordable alternatives to brand-name drugs—including blockbusters such as Ozempic and Victoza.
      • “The crackdown is the latest assault against what the agency regards as drugmakers’ patent ploys intended to stall generic competition.
      • “At issue is what is called the Orange Book, a document published by the Food and Drug Administration that lists patents relevant to brand-name pharmaceuticals. Under a law meant to encourage generics, if a generics maker can successfully challenge listed patents, it can be granted a period of exclusivity before other generics are approved. But a challenge to an Orange Book patent, should a brand-name manufacturer decide to fight in court, also delays a generic’s approval for 30 months.
      • “The FTC says that drugmakers needlessly list oodles of extra patents in the Orange Book, delaying generic alternatives and artificially keeping prices high.”
  • HealthLeaders Media adds,
    • “Medicare Part D saved nearly $15 billion over six years with the use of “skinny label” generics, a new report says.
    • “However, the program is imperiled by a lawsuit claiming patent infringement, researchers at Brigham and Women’s Hospital and Harvard Medical School said in a research letter published on Monday in Annals of Internal Medicine.
    • “The researchers are urging Congress to “reinforce the skinny-label pathway by creating a safe harbor that protects manufacturers engaged in skinny labeling from induced patent infringement laws.”
    • “Skinny labels permit the use of generics for conditions that are not specified by brand-name drug makers and allow the cheaper generics to enter the market before the patent of the brand-name drug expires. 
  •  The U.S. Preventive Services Task Force finalized a breast cancer screening recommendation today.
    • The Task Force now recommends that all women get screened for breast cancer every other year starting at age 40 [previously age 50 for USPSTF purposes and 40 for Affordable Care Act purposes] and continuing through age 74. This is a B grade. More research is needed about whether and how additional screening might help women with dense breasts stay healthy and on the benefits and harms of screening in women older than 75. These are I statements.
  • The New York Times adds,
    • “In 2009, the task force raised the age for starting routine mammograms to 50 from 40, sparking wide controversy. At the time, researchers were concerned that earlier screening would do more harm than good, leading to unnecessary treatment in younger women, including alarming findings that lead to anxiety-producing procedures that are invasive but ultimately unnecessary.
    • “But now breast cancer rates among women in their 40s are on the rise, increasing by 2 percent a year between 2015 and 2019, said Dr. John Wong, vice chair of the task force. The panel continues to recommend screening every two years for women at average risk of breast cancer, though many patients and providers prefer annual screening. * * *
    • “Weighing in again on a hotly debated topic, the task force also said there was not enough evidence to endorse extra scans, such as ultrasounds or magnetic resonance imaging, for women with dense breast tissue.
    • “That means that insurers do not have to provide full coverage of additional screening for these women, whose cancers can be missed by mammograms alone and who are at higher risk for breast cancer to begin with. About half of all women aged 40 and older fall into this category.”
  • For Affordable Care Act preventive services coverage purposes, HHS’s Human Resources and Services Administration, not the USPSTF, is the final decision maker regarding the scope of women’s healthcare preventive services.

From the public health and medical research fronts,

  • STAT News lets us know today.
    • “Research is still being done to determine if all pasteurization techniques — there are multiple approaches — inactivate the [H5N1] virus. But the findings so far are reassuring. Scientists at St. Jude Children’s Hospital in Memphis, Tenn., have reported that while they could find genetic evidence of the virus in milk bought in stores, they could not grow live viruses from that milk, suggesting pasteurization kills H5N1. * * *
    • “But given the concentration of virus that researchers are seeing in milk from infected cows, they believe that raw milk — milk that has not been pasteurized — is an entirely different story.
    • “If cows that produce milk destined for the raw milk market got infected with H5N1, people who consume that milk could drink a large dose of the virus, scientists say. Thijs Kuiken, a pathologist in the department of viroscience at Erasmus Medical Center in Rotterdam, the Netherlands, said he’s heard of concentrations that would be the equivalent of a billion virus particles per milliliter of milk. He told STAT he thought authorities should ban raw milk sales while the outbreak is underway.”
  • The Washington Post reports,
    • “Postpartum depression is a leading cause of maternal death, but its diagnosis and treatment is spotty at best, negligent at worst.
    • “Now San Diego-based start-up Dionysus Digital Health is pitching a blood test to check for the condition, even before symptoms appear. The company says it has pinpointed a gene linking a person’s moods more closely to hormonal changes. The test uses machine learning to compare epigenetics — how genes are expressed — in your blood sample with benchmarks developed during a decade of research into pregnant people who did and didn’t develop postpartum depression.
    • “Researchers at Dionysus’s academic partners, the Royal’s Institute of Mental Health Research and UVA Health, have published peer-reviewedpapers affirming their findings, and the company is partnering with the Department of Defense and the National Institutes of Health for clinical trials, with the eventual goal of making the $250 test widely available and covered by insurance.” 
  • The National Institutes of Health announced,
    • “Sleep apnea and low oxygen levels while sleeping are associated with epilepsy that first occurs after 60 years of age, known as late-onset epilepsy, according to a new study funded by the National Institutes of Health (NIH) and published in Sleep. The link was independent of other known risk factors for late-onset epilepsy and sleep apnea including hypertension and stroke. The findings may help to better understand the relationship between sleep disorders and late-onset epilepsy, as well as identify potential targets for treatment.
    • “There’s increasing evidence that late-onset epilepsy may be indicative of underlying vascular disease, or neurodegenerative disease, even potentially as a preclinical marker of neurodegenerative disease,” said Rebecca Gottesman, M.D., Ph.D., chief of the Stroke Branch at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), and an author on the study. “Compared to other age groups, older adults have the highest incidence of new cases of epilepsy – up to half of which have no clear cause. Sleep apnea is common among people with epilepsy, but the association is not well understood.”
  • and
    • “Researchers have discovered that the smooth muscle cells that line the arteries of people with atherosclerosis can change into new cell types and develop traits similar to cancer that worsen the disease. Atherosclerosis is characterized by a narrowing of arterial walls and can increase risk of coronary artery disease, stroke, peripheral artery disease, or kidney disorders. The findings, supported by the National Institutes of Health (NIH), could pave the way for the use of anti-cancer drugs to counteract the tumor-like mechanisms driving the buildup of plaque in the arteries, the major cause of cardiovascular disease.
    • “This discovery opens up a whole new dimension for our understanding about therapeutic strategies for the prevention and treatment of atherosclerosis,” said Ahmed Hasan, M.D., Ph.D., program director in the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute, part of NIH. “Previous research has suggested that atherosclerosis and cancer may share some similarities, but this association has not been fully described until now.”
  • The Wall Street Journal tells us,
    • “An emerging field of research called chrononutrition indicates that choosing the right foods and meal times may improve our sleep. Some key findings: Eat dinner early. Keep consistent schedules. And, yes, drink milk.
    • You already know that fruits, veggies and lean protein are good for your health. But they can boost your sleep, too. These foods are the basis for the Mediterranean diet, which research shows may improve sleep quality, reduce sleep disturbances and boost sleep efficiency—the amount of time you spend asleep when you are in bed.” 

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “Walmart is closing its network of health clinics after failing to make them profitable, in a major setback for the retail giant’s push into healthcare.”Walmart is closing its network of health clinics after failing to make them profitable, in a major setback for the retail giant’s push into healthcare.
    • “Walmart Health launched as a one-store pilot in Georgia in 2019, and has since grown to 51 centers in five states, along with a virtual care offering. Yet the network has shown recent signs of trouble: Earlier this month, Walmart decelerated its expansion plans for the centers, which offer inexpensive, fixed-cost medical services like primary and dental care.
    • “Walmart is now closing the clinics entirely due to a challenging reimbursement environment and escalating operating costs resulting in a lack of profitability, according to a Tuesday press release. * * *
    • “In the end of Walmart Health illustrates that size alone is not a recipe for success in providing health services, according to Forrester’s Trzcinski. Walmart is the largest retailer in the U.S., with revenue of $648 billion in its most recent fiscal year.
    • “Despite building out the clinics, Walmart didn’t invest in driving adoption, including through digital health and customer experience, Trzcinski said. That caused it to fall behind other retailers that are surging ahead, such as Amazon and CVS.”
  • Per BioPharma Dive,
    • “Eli Lilly raised its revenue forecast for the year by $2 billion as sales of its GLP-1 medicines for diabetes and obesity continue to climb rapidly amid surging demand.
    • “The Indianapolis drugmaker currently can’t make its drugs Mounjaro and Zepbound fast enough, indicating in an earnings statement Tuesday that sales growth will “primarily be a function of the quantity the company can produce and ship.”
    • “Lilly is expanding manufacturing and expects greater capacity in the second half of the year. Revenue from Mounjaro, which is sold for diabetes, totaled $1.8 billion in the first quarter, while Zepbound revenue hit $517 million in its first full quarter on the U.S. market as an obesity treatment.”
  • and
    • “Lilly and Novo [Nordisk] aim to maintain their current hold on the market. Both companies are testing several experimental drugs with the goal of launching oral versions or even more effective treatments than their current products.
    • “Novo is already close to completing a Phase 3 trial program testing an oral form of Wegovy. It also has in late-stage development a combination of Wegovy with a compound called cagrilintide that acts on a gut hormone called amylin.
    • “Lilly has two drugs in Phase 3: an oral GLP-1 dubbed orforglipron that is approaching key data readouts next year and an injectable treatment called retatrutide that stimulates GLP-1, GIP and a third hormone known as glucagon. Results in obesity are due in 2026.
    • “Lilly has four experimental drugs in Phase 1 or 2, while Novo has five.
    • “[Lilly and Novo] cover all the bases,” said Clive Meanwell, CEO of Metsera, a newly launched startup that has two obesity drugs in clinical testing. “Our belief is it’s going to be a portfolio play, with mix and match, with different clinical circumstances and different markets.”
    • The article discusses similar projects from other companies.
  • Beckers Payer Issues reports,
    • “CMS and the NCQA are extending the quality data submission deadline for health plans by two weeks due to “extraordinary circumstances” caused by the cyberattack on Change Healthcare in late February.
    • “Payers will now have until 5pm Eastern Time on June 28 to report their performance on Healthcare Effectiveness Data and Information Set (HEDIS) measures to the two organizations, according to an April 29 memo from CMS. * * *
    • “The Change Healthcare cyberattack has created unprecedented challenges to healthcare organizations across the country,” Eric Schneider, MD, EVP, Quality Measurement and Research Group at NCQA, said in a statement to Becker’s. “This disruptive incident, falling in the middle of the substantial effort and commitment required for quality reporting efforts, has significantly strained resources. Recognizing these extraordinary circumstances and in alignment with CMS, we are granting a deadline extension for the submission of HEDIS Measurement Year 2023 results.” 

Monday Roundup

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

From Washington, DC,

  • MedTech Dive reports
    • “The Food and Drug Administration released a final rule on Mondaystrengthening its authority over laboratory developed tests (LDTs), advancing a policy that has drawn fierce opposition from healthcare industry groups.
    • “The rule amends agency regulations to make explicit that in vitro diagnostics are devices under the Federal Food, Drug and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.
    • “The FDA said it will phase out its enforcement discretion approach for LDTs so that in vitro diagnostics manufactured by a laboratory will generally fall under the same enforcement policy as other tests.”
  • HHS’s Office for Civil Rights issued frequently asked questions about the final ACA Section 1557 rule issued on Friday.
  • Bloomberg lets us know,
    • “The US Department of Labor has rescinded a Trump-era rule that made it easier for small businesses and self-employed people to use cheaper association health plans that don’t comply with all the requirements of the Affordable Care Act. 
    • “The final Biden rule (RIN:1210-AC16) on association health plans was issued by the DOL’s Employee Benefits Security Administration Monday after clearing White House review, and will take effect 60 days after its April 30 publication in the Federal Register.”
  • HHS announced,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced $105 million in funding to support more than 100 community-based organizations working to improve maternal and infant health. HRSA Administrator Carole Johnson highlighted the news during a visit to Southside Medical Center, a new Healthy Start awardee, in Atlanta, Georgia. Georgia is the second stop on HRSA’s national Enhancing Maternal Health Initiative tour. Today’s Healthy Start funding announcement will support the health care and social needs of moms and babies in high need communities to help improve community health and tackle the unacceptable disparities in maternal and infant health outcomes. * * *
    • “For the full list of award recipients, visit the Healthy Start awards page.”

From the public health and medical research front,

  • The Washington Post reports,
    • “After decreasing for 27 years, the number of U.S. residents with tuberculosis has increased every year since 2020, with 9,615 cases recorded last year in the 50 states and D.C., according to a report from the Centers for Disease Control and Prevention.”After decreasing for 27 years, the number of U.S. residents with tuberculosis has increased every year since 2020, with 9,615 cases recorded last year in the 50 states and D.C., according to a report from the Centers for Disease Control and Prevention.
    • “The finding was based on data from the agency’s National Tuberculosis Surveillance System, which collects information from state and local health departments.
    • Caused by bacteria, tuberculosis usually attacks the lungs and spreads easily from person to person through the air. People who have the disease can spread the bacteria when they cough, sneeze or simply talk. * * *
    • “The latest numbers reflect a 16 percent increase in U.S. tuberculosis cases from 2022 to 2023, and the highest number of TB cases in the country since 2013, the CDC report says. The tally also reflects increases in all age groups and among people born in the United States as well as those born elsewhere, although the report found a larger increase among people born outside the United States vs. U.S.-born individuals (18 percent vs. 9 percent).
    • “Despite the recent increases, the CDC report describes the incidence of TB in the United States as “among the lowest in the world.”
  • The New York Times tells us,
    • “Physical fitness among children and adolescents may protect against developing depressive symptoms, anxiety and attention deficit hyperactivity disorder, according to a study published on Monday in JAMA Pediatrics.
    • “The study also found that better performance in cardiovascular activities, strength and muscular endurance were each associated with greater protection against such mental health conditions. The researchers deemed this linkage “dose-dependent”, suggesting that a child or adolescent who is more fit may be accordingly less likely to experience the onset of a mental health disorder.”
  • The CDC updated its online guidance about action to fight antimicrobial resistance.
    • Antimicrobial resistance happens when germs like bacteria and fungi develop the ability to defeat the drugs designed to kill them. That means the germs are not killed and continue to grow. Antimicrobial resistance has been found in every U.S. state and country. Addressing this threat requires continued aggressive action to:
      • Prevent infections in the first place
      • Improve antibiotic and antifungal use to slow the development of resistance
      • Stop the spread of resistance when it does develop
    • We all have a role to play, from travelers, animal owners, and care givers to patients and healthcare providers. Find out how you can help.

From the U.S. healthcare business front,

  • Fierce Healthcare relates,
    • “Inpatient volume growth across HCA Healthcare’s entire hospital portfolio and other steady gains on payer mix, length of stay and operating expenses have set the large chain on a strong trajectory for 2024, executives told investors Friday.
    • “The 188-hospital for-profit reported first-quarter net income of $1.59 billion ($5.93 per diluted share) and $17.34 billion in revenues.
    • “Those numbers are up from the $1.36 billion ($4.85 per diluted share) and $15.59 billion of the same period last year, and squarely ahead of consensus estimates of $5.09 earnings per share and $16.82 billion in revenues.”
  • and
    • “Teladoc acting CEO Mala Murthy sought to assure investors Thursday that the virtual care giant is poised for future growth even as it faces pressure in a saturated telehealth market.
    • “Following the abrupt departure of longtime CEO Jason Gorevic earlier this month, Teladoc is focused on boosting its top- and bottom-line performance as its shares have come under pressure, down more than 40% year-to-date.
    • “Teladoc is in a time of transition. And, as part of this evolution, the board of directors decided that it was time to look for a new leader for our company, someone to help us write the next chapter in our growth story,” Murthy, also Teladoc’s chief financial officer, said during the company’s first-quarter earnings call Thursday.”
  • Per Beckers Hospital Review,
    • “Increased reliance on imaging for diagnosis and efficient patient care mixed with higher volumes of patients has left hospitals scrambling to meet demand with the few radiologists they have.
    • “There are over 1,400 vacant radiologist positions posted on the American College of Radiology’s job board, according to a bulletin posted on its website. The total number of active radiology and diagnostic radiology physicians has dropped by 1% between 2007 and 2021, but the number of people in the U.S. per active physician in radiology grew nearly 10%, according to the Association of American Medical Colleges. An increase in the Medicare population and a declining number of people with health insurance adds to the problem.”
  • and
    • Demand for Type 2 diabetes drug Ozempic is high across the U.S., but interest varies by state, according to research conducted by Bison Pharmacy. 
    • Bison Pharmacy, a Canadian-based prescription referral service, analyzed monthly volume data on Google searches for “Ozempic” and “Ozempic price” in each state. 
    • New York is at the top of the list and Mississippi is on the bottom.

Midweek Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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