Weekend Update

Rx coverage

Weekend Update

David Ermer–CDC, CMS, Congress, Cybersecurity, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • Reuters adds, “U.S. President Joe Biden will put forth his proposed U.S. spending plan [tomorrow] March 11, according to the White House Office of Management and Budget.”
  • Today, the Department of Health and Human Services posted a letter to healthcare leaders about the Change Healthcare cyberattack.
    • We urge insurance companies and other payers to:
      • Make interim payments to impacted providers. Larger payers in particular have the balance sheet stability to advance payments. Payers have the opportunity to stop-gap the cash flow concerns by stepping in with bridge payments [FEHBlog note — assuming that the payer doesn’t rely on Change Healthcare for backend claims processing.}
      • In particular, for Medicaid plans, consider making interim payments to impacted providers.
      • Ease the administrative burden on providers by simplifying electronic data interchange requirements and timelines and by accepting paper claims. 
      • Pause prior authorizations and other utilization management requirements; use all available leeway on deadlines.
  • The Washington Post further reports,
    • “Federal health officials on Saturday said they would offer emergency funding to physicians, physical therapists and other professionals that provide outpatient health care, following a cyberattack that crippled the nation’s largest processor of medical claims and left many organizations in financial distress.
    • “The Centers for Medicare and Medicaid Services also announced that it would make advance payments available to suppliers that bill through Medicare Part B, which serves a wide array of health-care organizations. Officials had previously announced a similar program to make emergency payments available for hospitals that had been ensnared by the Feb. 21 hack of Change Healthcare, a unit of UnitedHealth Group, and have struggled to get paid for more than two weeks. The emergency funds represent upfront payments made to health-care providers and suppliers based on their expected future claims. * * *
    • “It’s going to help significantly,” added Farzad Mostashari, the CEO of Aledade, the nation’s largest network of independent physician practices. Mostashari had previously warned that as many as 25 percent of physician practices were in financial distress.”

From the public health and medical research front,

  • According to the Centers for Disease Control,
    • “Activity Levels Update:
      • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 20 jurisdictions experienced high or very high activity compared to 26 jurisdictions previous week.
      • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
      • “Influenza test positivity remained stable nationally. COVID-19 and RSV test positivity decreased compared to the previous week.
      • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, has decreased to moderate.
    • “Reported on Friday, March 8th, 2024.“
  • Fortune Well offers advices on pregnancy in advance maternal age (at age 35 or older).
  • The Washington Post tells us,
    • “Tai chi, a gentle Chinese martial art involving slow movements, outperformed moderate aerobic exercise in lowering blood pressure in a recent clinical trial.
    • “An analysis, published in JAMA Network Open, tracked 342 18- to 65-year-olds with prehypertension, or blood pressure that is slightly higher than normal, between late July 2019 and mid-January 2022. * * *
    • “These findings support the important public health value of Tai Chi to promote the prevention of cardiovascular disease in populations with prehypertension,” the researchers conclude. Other research continues to explore the potential benefits of tai chi. The exercises are associated with better balance, fall reduction, and benefits for patients with conditions such as arthritis and fibromyalgia.”
  • Bloomberg discusses measles prevention practices for adults born after 1957.
    • “[Katrine Wallace, an epidemiologist at University of Illinois Chicago] says, adults are sufficiently protected from the measles if one of these four things applies to you:
      • “You had measles at some point in your life.
      • “You were born before 1957.
      • “You’ve had two doses of a measles-containing vaccine if you spend time in a high-risk setting for transmission, like schools or hospitals. 
      • Y”ou’ve had one dose of a vaccine if you don’t spend time in high-risk settings. 
      • “Kids and teens need one or two doses for protection depending on their age.” 
    • If you aren’t sure whether you’ve been vaccinated or had the measles, you can get what’s called an MMR titer test, which is available commercially at various labs for about $129, Wallace advises.
  • The Wall Street Journal delves into the development of individual body organ tests.
    • “Measuring organ age is the latest frontier in the world of biological age, the idea that your body’s physical age can be different from its chronological one. For example, a 50-year-old man hypothetically might have physical health that more closely resembles that of a 53-year-old, with, say, a 51-year-old heart and a 54-year-old brain.
    • “Knowing the age of your organs might one day help you prevent and treat disease. In theory, if you knew that your heart was aging too fast, you could take steps to ward off heart disease.
    • “Heart aging predicts future heart disease, and brain aging predicts future dementia,” says Hamilton Oh, one of the paper’s lead authors and a graduate student at Stanford.
    • “Walking into your doctor’s office and getting a simple test to determine your organ age is likely still a ways off, but the concept is gaining interest among researchers, doctors and people focused on their own longevity and health. Scientists caution that more research is needed before such a technology might be ready for mainstream use. Some also say that parts of the recent study made too many assumptions.”

From the U.S. healthcare business front,

  • The Dispatch informs us,
    • “A 2021 study published by the RAND Corporation found that, even after rebates and other discounts, U.S. prescription drug prices were, on average, nearly twice as high as those in countries including Canada, France, Germany, Japan, and the United Kingdom. A 2024 study, also conducted by the RAND Corporation for the Office of the Assistant Secretary for Planning and Evaluation, similarly found that 2022 drug prices in the U.S. were nearly three times higher than those in the 33 Organisation for Economic Co-operation and Development (OECD) countries used in the comparison.
    • “However, the study also found that, on average, unbranded generic drugs were about a third cheaper in the U.S. than in other comparison countries, meaning Americans are actually paying less for these drugs than they would elsewhere. “This finding suggests that robust price competition in U.S. unbranded generic markets continues to drive savings for consumers and health care payers relative to spending on these drugs in other countries,” the study said. Even though generic drugs make up 90 percent of U.S. prescription volume, the substantially higher cost for brand-name drugs still results in a higher average cost for all drugs in the U.S. than elsewhere, according to the report.”
  • HR Dive lets us know,
    • “Judge J. Campbell Barker of the U.S. District Court for the Eastern District of Texas vacated the National Labor Relations Board’s joint employer rule late Friday. The rule was set to go into effect Monday.
    • “The new rule would be “contrary to law” and “arbitrary and capricious,” Barker ruled. The court had been considering a legal challenge brought in November by the U.S. Chamber of Commerce, along with other business groups. 
    • “Federal agencies and employers now await a possible court decision on the U.S. Department of Labor’s independent contractor rule, also set to go in effect Monday.”

Happy International Women’s Day

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, NIH, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Dulcey Lima on Unsplash

The International Foundation of Employee Benefit Plans celebrates International Women’s Day. “International Women’s Day is an ideal time to pause and reflect on the status of women in the workforce—both how far we’ve come and how far we still need to go to achieve true gender equality. “

Mercer Consulting adds, “Women are hugely concerned about the state of their personal finances – and too often, employers have fallen short of providing the support their people need. For too long, financial health has trailed behind physical and mental health on the list of employers’ priorities. Now is the time to act!” The article explains how to act.

From Washington, DC,

  • The Wall Street Journal reports,
    • The Senate on Friday passed a $460 billion spending bill to keep the U.S. government operating, taking a potential shutdown for several agencies off the table for the rest of the fiscal year.
    • In a 75-22 vote, Senate lawmakers approved budgets for federal agencies including the Agriculture, Justice, Transportation and Interior departments through the end of September, just hours before some agencies were scheduled to run out of money. The vote came after several nervous hours of negotiations over votes on amendments demanded by Republicans as a condition for the final vote.
    • The measure now heads to President Biden for approval.
  • Healthcare Finance News adds,
    • “A 3.34% physician payment reduction began January 1. [spending] The legislation  [includes] a prospective increase of 1.68% to Medicare physician reimbursement effective March 9, according to MGMA.
    • “Medical groups would still be left with a 1.69% reduction in reimbursement for the rest of the year.”
  • Fierce Healthcare informs us,
    • “[On Thursday night,] President Joe Biden promised the country further action on prescription drug prices, insurance coverage and reproductive care access during a State of the Union Address that doubled as an early campaign speech.
    • With a presidential election months away, the White House hasn’t held back from promoting its recent efforts on issues at the front of voters’ minds such as the cost of American healthcare and abortion. Though Biden’s address included several calls for policy support from Congress, he wasn’t shy about making his pitch directly to watching voters who could tip the scales in his office’s favor. * * *
    • “Biden asked Congress to build upon the Inflation Reduction Act (IRA) to increase the number of products subject to Medicare drug price negotiations.
    • Rather than the current 20-drug-per-year limit, Biden asked lawmakers for the authority to negotiate prices for 50 drugs a year, or “500 different drugs over the next decade,” he said.
    • “Additionally, the president called to extend the $2,000 out-of-pocket cap on prescription Medicare drugs (set to go into effect in 2025) to all private insurance.
    • “Per the fact sheets, he is also pushing for a similar expansion of another IRA requirement—that drug manufacturers pay rebates to Medicare for certain drug price increases that exceed inflation—to the commercial market. He illustrated that goal during the address by calling for Medicare’s $35-per-month cap on insulin to apply “to every American.”
  • The U.S. Office of Personnel Management issued its FEHB and PSHB technical guidance to carriers who are preparing 2025 benefit and rates proposals in response to the February 8, 2024, call letter.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “A large clinical trial meant to confirm the benefits of a new ALS medication has instead failed, dealing a major blow to the therapy’s developer as well as patients who had hung their hopes on it.
    • “Amylyx Pharmaceuticals disclosed Friday morning that the drug, known as Relyvrio in the U.S., didn’t meet the trial’s main or secondary goals. Though well-tolerated by participants, Relyvrio was not significantly better than a placebo at changing the trajectory of their disease.
    • “For Amylyx, the results are a monumental setback. The Massachusetts-based biotechnology company was built entirely around Relyvrio, which received approval from the Food and Drug Administration in the fall of 2022. Early sales made Amylyx profitable – a rare victory for any young drugmaker. * * * By the end of September, nearly 4,000 of the roughly 30,000 ALS patients in the U.S. were on Relyvrio, according to Amylyx’s estimates. * * *
    • “Now, the company’s future is unclear. Before Relyvrio’s approval, Amylyx co-founders Justin Klee and Joshua Cohen pledged, at the request of a top FDA official, to pull their drug from the market should confirmatory testing fail.
    • “In a statement, Amylyx said that sometime in the next eight weeks, it will share its plans for Relyvrio, which “may include voluntarily withdrawing [the drug] from the market.” The company also intends to discuss the new results with regulators, doctors and the broader amyotrophic lateral sclerosis community.
    • “In the meantime, Amylyx will pause promoting the product.”
  • STAT News tells us,
    • “In a surprise move, the Food and Drug Administration has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved, even as many outsiders expected the medicine to receive regulatory clearance this month.
    • “The drug, donanemab, succeeded in its Phase 3 trial, resulting in a 35% slowing of Alzheimer’s disease progression versus placebo. But Lilly on Friday said that the FDA expects to call a meeting of an advisory committee to review the trial, saying that the agency had told the company “it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design” of the study.
    • “A date for the meeting has not been set yet.
    • “Lilly previously said a regulatory decision was expected by the end of 2023, but had already pushed that back to the first quarter of 2024. In its statement Friday, it said simply that “the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024.”

From the public health and medical research front,

  • The Hill informs us,
    • “The rash of measles outbreaks around the country has sparked concerns that the U.S. risks losing its status as a country where the disease has been eliminated, a distinction held since 2000.
    • “As of last week, 41 measles cases have been confirmed across 15 states and New York City, according to the Centers for Disease Control and Prevention (CDC). That puts the nation already on track to surpassing the 58 total cases that were detected in 2023.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services unveiled a new Framework to accelerate smoking cessation and reduce smoking- and cessation-related disparities.  This action is part of a broader Department-wide effort to advance the Biden Cancer Moonshot goal of reducing the death rate from cancer by at least half over 25 years.
    • “Every person in America should have access to the tools and programs they need to quit smoking. And we must encourage and assist every person in America who wants to quit smoking to do so,” said Secretary Xavier Becerra. “This framework focuses on advancing equity, engaging communities, and coordinating, collaborating, and integrating evidence-based approaches across every facet of our government and society. The Biden-Harris Administration will continue these efforts until smoking is no longer the leading cause of preventable death in the United States, and the communities that remain the most vulnerable get the help they need.”
    • “The HHS Framework to Support and Accelerate Smoking Cessation – PDF provides a unifying vision and set of common goals to help drive progress towards cessation, especially in populations and communities that experience smoking- and cessation-related disparities. It is focused specifically on supporting and accelerating the cessation of combusted tobacco products, including cigarettes, cigars, little cigars, and cigarillos among people of all ages.”
  • The National Institutes of Health announced,
    • “A topical liquid, silver diamine fluoride (SDF), can stop tooth decay in young children, according to a large clinical trial funded by the National Institutes of Health. The preliminary results, published in Pediatric Dentistry, showed that 54% of cavities stopped progressing after SDF treatment, compared to 21% of those treated with a placebo. The study was funded by the National Institute of Dental and Craniofacial Research (NIDCR), part of NIH.
    • “SDF is cleared by the Food and Drug Administration for treating dental sensitivity and is used off label to treat tooth decay, also known as cavities or dental caries. It can be easily and painlessly swabbed onto cavities and has been widely used for management of tooth decay in other countries for decades. Studies suggest that the silver in SDF kills cavity-causing microbes and helps stop destruction of the tooth, while the fluoride helps to rebuild and strengthen the tooth.
    • “Current treatments for severe early childhood caries rely on restoration and tooth extraction, which can involve general anesthesia,” said lead investigator Margherita Fontana, D.D.S., Ph.D., of the University of Michigan. “These interventions are expensive, cavities often return, and anesthesia can have long-term effects on a developing brain. We didn’t really have any other options until recently — SDF is a game changer.”
  • The New York Times relates,
    • “Increasingly, doctor visits by adolescents and young adults involve mental health diagnoses, along with the prescription of psychiatric medications.
    • “That was the conclusion of a new study that found that in 2019, 17 percent of outpatient doctor visits for patients ages 13 to 24 in the United States involved a behavioral or mental health condition, including anxiety, depression, suicidal ideation, self-harm or other issues. That figure rose sharply from 2006, when just 9 percent of doctor’s visits involved psychiatric illnesses.
    • “The study, published Thursday in JAMA Network Open, also found a sharp increase in the proportion of visits involving psychiatric medications. In 2019, 22.4 percent of outpatient visits by the 13-24 age group involved the prescription of at least one psychiatric drug, up from 13 percent in 2006.”
  • The Wall Street Journal points out,
    • “More parents with young children are taking melatonin to sleep. And some of them are going to the emergency room after their children took melatoninaccidentally. 
    • “The number of children who visited emergency rooms for unsupervised melatonin consumption increased 420% from 2009-2020, federal data showed. Melatonin was implicated in some 7% of recent E.R. visits for children 5 and younger who had taken medication without supervision. 
    • “The good news: Very few of those children were hospitalized. Typically, mild drowsiness, headaches or dizziness are the worst side effects after children consume melatonin, according to America’s Poison Centers.
    • “Adults have long used melatonin, a hormone the brain produces in response to darkness, to regulate their sleep. It is sold widely as a dietary supplement.”
  • The MIT Technology Review lets us know,
    • “As a fetus grows in the womb, it sheds cells into the amniotic fluid surrounding and protecting it. Now researchers have demonstrated that they can use those cells to grow organoids, three-dimensional structures that have some of the properties of human organs—in this case kidneys, small intestines, and lungs. These organoids could give doctors even more information about how fetal organs are developing, potentially enhancing prenatal diagnoses of conditions like spina bifida.
    • “These aren’t the first organoids produced from fetal cells. Other groups have grown them from discarded fetal tissue. But this group is among the first to grow organoids from cells taken from amniotic fluid, which can be extracted without harming the fetus.
    • “The entire concept is really groundbreaking,” says Oren Pleniceanu, a stem cell biologist and head of the Kidney Research Center at Sheba Medical Center and Tel-Aviv University who has also been working on organoids from amniotic fluid. This ability to get fetal cells from the amniotic fluid, “it’s like a free biopsy,” he says. But he points out that there’s still room for improvement when it comes to describing the cells that are present. “It’s not that easy to define which cells these are,” he says.”  

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “The No Surprises Act, which aims to protect patients from costly surprise medical bills is becoming “an unmitigated disaster for employers,” according to the head of the one of the largest industry groups for employer-sponsored health plans. 
    • “The trends are bad and getting significantly worse, and I really do worry that we’re going to see a trend towards much higher inflationary factors,” Shawn Gremminger, president and CEO of the National Alliance for Healthcare Purchaser Coalitions, said at a Georgetown University forum on the No Surprises Act Thursday.
    • “The law has largely protected consumers from “surprise” bills in emergencies and when they receive care from out-of-network medical providers at facilities that are in their insurance networks.
    • “But employers and health insurers that pay the bills say they are increasingly alarmed at high awards private-equity owned providers are winning in arbitration, which they say could lead to higher premiums for both employers and their enrollees, as well as higher out-of-pocket costs for consumers.”
  • How does one square this report with yesterday’s CBO report about the savings that the NSA is producing? Providers generally accept the qualifying payment amounts the No Surprises Act requires them to pay.
  • The Employee Benefit Research Institute posted an Issue Brief about “Health Savings Account Balances, Contributions, Distributions, and Other Vital Statistics: Evidence From the EBRI HSA Database”
  • Healthcare Dive offers details on UHC updates on the Change Healthcare situation.
    • Change Healthcare systems are expected to come back online starting in mid-March, about a month after a cyberattack disabled the technology firm, parent company UnitedHealth Group said Thursday. 
    • Electronic payments will be available beginning March 15, and electronic prescribing is fully functional as of Thursday. Change will start testing its claims network and software on March 18, with plans to restore service through that week.
    • UnitedHealth also said it would give additional financial relief to providers, including advancing funds weekly and expanding the temporary financing program it announced earlier this month.
  • Healthcare Dive also delves into Cigna’s announcement that
    • “Cigna is moving to limit how much health insurance providers and employers have to pay for pricey and in-demand obesity medications.
    • “The insurer plans to cap annual price increases for the drugs, called GLP-1 receptor agonists, at 15% for employers and plans participating in a weight loss management program offered by its pharmacy benefit manager.
    • “It’s the first financial guarantee available in the market for the drugs, according to the payer. Cigna’s health services division Evernorth, which includes PBM Express Scripts, announced the news on Thursday before the insurer’s investor day in New York City.”
  • Business Insurance adds,
    • “Cigna Group’s Evernorth Health Services is launching an outpatient behavioral health practice to integrate mental health services with medical care, Forbes reports. The new service, currently available in six states and Washington, D.C., guarantees an appointment with a clinician matching the patient’s unique goals and preferences within 72 hours. Evernorth plans a nationwide rollout by early 2025.”
  • Beckers Health IT notes,
    • “The average cost per email for patients to message their provider was $39, according to data compiled and reported by Peterson-Kaiser Family Foundation.
    • “KFF examined data from the Health Care Cost Institute on physician and outpatient claims from 2020 and 2021 for patients under the age of 65 years old with employer-sponsored insurance. Billing codes for email interactions were first introduced in 2020 amid the COVID-19 pandemic for providers to bill insurers for at least 5 minutes spent responding to patient-initiated emails.
    • “The analysis focused on email messages associated with charges. Researchers found the average claim for emailed correspondence was $39, and patients paid around $25 out of pocket, according to the report. Depending on their benefits package, some patients paid up to $40 out of pocket.”
  • Per Fierce Healthcare,
    • “Renton, Washington-based Providence closed out its year with a -4.1% operating margin and a $596 million net loss but touted “significant progress in operating performance” and an 8.7% year-over-year gain in total operating revenues outpaced by a 7.3% rise in total operating expenses.
    • “The 51-hospital Catholic system was coming off a year of heavy expenses and organizational upheaval. In 2022, it had logged a -6.4% operating margin from a $1.7 billion operating loss, which included $247 million tied to a restructuring it had launched to address spending, as well as a $2.7 billion net loss (excluding $3.4 billion tied to its split with Hoag Memorial Hospital Presbyterian).
    • “This time around, Providence whittled its operating losses down to about $1.2 billion and highlighted gains in volumes. Specifically, it saw a 4% uptick in acute adjusted admissions, a 5% increase in case-mix adjusted admissions and a 3% decline in length of stay “as access to post-acute care improved.” Non-acute volumes also grew 2% on the back of an 11% increase in outpatient surgeries and procedures.”
  • Beckers Payer Issues points out three BCBS companies reporting 2023 losses “due to ongoing trends such as rising utilization in the Medicare Advantage space and growing demand for weight loss drugs. 

Thursday Miscellany

David Ermer–Cybersecurity, HSA, Medical / Rx research, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Congressional Budget Office posted a presentation about “CBO’s Approach to Estimating the Budgetary Effects of the No Surprises Act of 2021.”
    • “This presentation describes CBO’s approach to estimating the budgetary effects of the No Surprises Act. The stated aim of the No Surprises Act was to protect patients from surprise billing. The law:
    • “Established protections for patients receiving out-of-network care,
    • “Established an arbitration process for resolving payment disputes, and
    • “Directed arbiters to consider the qualifying payment amount, defined as the median in-network rate, as the benchmark for payment (with other factors).
    • “CBO projected that reductions in prices paid to providers would reduce insurers’ costs, in turn reducing premiums by roughly 1 percent and reducing federal deficits from 2021 to 2030 by a total of $17 billion.”
  • The Internal Revenue Service warned consumers to “Beware of companies misrepresenting nutrition, wellness and general health expenses as medical care for FSAs, HSAs, HRAs and MSAs.”
  • Fedweek tells us,
    • “In a series of recent reports, the OPM inspector general’s office said it has identified misspending in the FEHB program, which adds to the cost of premiums both for the enrollees and the government, but that legal barriers prevent the program from recouping some of that amount.
    • “A report covering the last three months of 2023 is typical in noting that the FEHB program is precluded from pursuing cases under the Anti-Kickback Statute, which makes it illegal for health care providers to knowingly and willfully accept bribes or other forms of remuneration in return for activities such as patient referrals.”
  • Query me this. How can there be misspending when Congress decided in 1996 not to apply this law to the FEHBP because it is operated by commercial entities? It’s sour grapes.
  • Federal News Network informs us,
    • The Office of Personnel Management’s retirement backlog made huge improvements in claims processed for February reaching 10,025, the highest number since April 2023. OPM received  8,794 claims in February and managed to process more than 3,000 claims compared to January.
    • After seeing a large increase in the inventory backlog in January, OPM made small improvements shrinking the backlog by 1,231  to a total of 19,591 claims in February. With a slight decrease in the backlog, OPM is still over 6,000 claims above the steady goal of 13,000.
    • OPM also saw improvements for the average processing time for February,  reaching 47 days, setting a new record.

From the public health and medical research front,

  • STAT News reports good news,
    • “A new monoclonal antibody product to protect against respiratory syncytial virus was 90% effective at preventing little children from being hospitalized with RSV, according to new data from the first season it was in use.
    • “The data, published Thursday in Morbidity and Mortality Weekly Report, a Centers for Disease Control and Prevention publication, looked at how well Beyfortus worked in the children whose parents managed to secure a scarce dose of the drug. These are the first real-world data showing how effective the product was in the United States.
    • “It’s basically really good news,” said Sean O’Leary, a professor of pediatrics at the University of Colorado School of Medicine and a pediatric infectious diseases specialist at Children’s Hospital Colorado. “In some clinical trials we see some level of effectiveness … but then when it’s rolled out in the real world, for any number of potential reasons, things don’t work out as well as they had in the clinical trials.”
    • “In this case, it’s great. The point estimate they came up with is even better than in the clinical trials,” said O’Leary, who was not involved in the study.
    • “AstraZeneca and Sanofi jointly developed Beyfortus, which is sold in the U.S. by Sanofi.”
  • and
    • “A pill being developed by Danish drugmaker Novo Nordisk may lead to greater weight loss than the obesity therapy Wegovy, the company reported Thursday, citing early data.
    • “In a Phase 1 trial, participants experienced an average of 13.1% weight loss after 12 weeks of taking the experimental oral medicine amycretin, according to data presented at an investor meeting. In comparison, in an earlier Phase 3 trial of the injectable drug Wegovy, people taking Wegovy lost about 6% of their body weight over the same time period. * * *
    • “Novo Nordisk isn’t the only pharma company working on a pill. An experimental pill being developed by Eli Lilly led to 14.7% weight loss in a 36-week, Phase 2 trial. Pfizer had been developing an oral medication, as well, but opted to shut down that product’s developmentdue to disappointing trial results.
    • “Many other companies are also testing oral obesity drugs, according to the STAT Obesity Drug Tracker.”

From the U.S. healthcare business front,

  • Beckers Hospital Review considers why healthcare cyberattacks last so long.
    • “The cyberattack on Change Healthcare that has caused disruptions across a wide swath of the industry has entered its third week. But why do these IT outages last so long?
    • “It’s a combination of ensuring that the hackers are no longer in the system and securing the vulnerability that allowed them to breach it in the first place, according to John Riggi, national advisor for cybersecurity and risk at the American Hospital Association.
    • “The victim must figure out how the bad guys broke into their network, where they are, throw them out and then seal that technical ‘hole,'” Mr. Riggi told Becker’s. * * *
    • “But Mr. Riggi, who spent more than two decades at the FBI, said it could take even longer to fully recover. “These disruptions could linger for several months or a year, and legacy systems that may not have been backed up or destroyed during the attack may become totally unrecoverable,” he said.”
  • United Healthcare offers a March 7 update on its Change Healthcare cyber response website.
  • Beckers Hospital Review also names ten drugs poised to be best seller this year and discusses “Newsweek‘s 2024 “America’s Greatest Workplaces for Women” ranking, which includes hospitals and health systems.”
  • Business Insurance reports,
    • While inflation in the general economy has slowed since 2022, workers compensation payment growth is still at levels higher than in 2020, experts with the Workers Compensation Research Institute said Tuesday.
    • Changes in medical care utilization and mix of services continue to affect workers comp pricing, and the recent trend of health care labor shortages, especially in nursing, is also contributing to higher costs, panelists said during a session at the 2024 WCRI Issues & Research Conference.
  • The Hill relates,
    • Drugmaker Boehringer Ingelheim plans to cap the out-of-pocket costs for all its inhalers at $35 per month after coming under fire from Democratic lawmakers over pricing. 
    • The company announced Thursday that the program will start June 1. It’s aimed at patients with employer-sponsored insurance, and those who are underinsured and uninsured, meaning they likely have to pay cash. 

Monday Roundup

David Ermer–CDC, Congress, COVID-19 testing, Cybersecurity, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • American Hospital Association (“AHA”) News tells us
    • The House and Senate Appropriations Committees March 3 released a package of six appropriations bills that would fund certain federal agencies through fiscal year 2024 and contains certain health care provisions of interest to hospitals. The House is expected to consider the legislation by March 6 and the Senate later this week.  
    • The health care provisions would eliminate Medicaid disproportionate share hospital cuts for FY 2024 and delay FY 2025 DSH cuts to Jan. 1, 2025; extend the Medicare-dependent hospital and enhanced low-volume hospital programs through December 2024; reduce a 3.34% physician payment cut that began Jan. 1; and extend the Community Health Centers, National Health Service Corps, and Teaching Health Centers Graduate Medical Education programs through December.
  • Govexec points out the eight biggest agency and program reforms in this package.
  • STAT News informs us that a “small group of policymakers and business people” spoke out against the three big prescription benefit manager at today’s White House listening session.
    • “The big three [pharmacy benefit managers] are everything wrong with this industry,” said Mark Cuban, who co-founded the Cost Plus Drug Company and is trying to cut out the middlemen with a website that sells mostly generic medicines directly to consumers. As part of the effort, his company is also working with smaller pharmacy benefit managers that do not rely on fees in hopes of appealing to employers.
    • “Along with Cuban, the session also featured remarks from Kentucky Gov. Andy Beshear who, as the state’s attorney general, investigated pharmacy benefit managers; Federal Trade Commission Chair Lina Khan, who is currently probing these companies; and Sandra Clarke, executive vice president and chief operating officer at Blue Shield of California, which is pursuing a new pharmacy model.”
  • The FEHBlog does not understand why the White House does not also listen to the PBMs and their supporters. Perhaps that will be the next listening session.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced today that all manufacturers participating in the first cycle of Medicare drug price negotiations have responded with counteroffers. This news comes after HHS sent initial offers on February 1, as the agency was empowered to do by President Biden’s lower cost prescription drug law, the Inflation Reduction Act. This law is a cornerstone of the Biden-Harris Administration’s efforts to lower prescription drug costs. * * *
    • “The recently launched website LowerDrugCosts.gov is a resource to help people with Medicare understand how the Inflation Reduction Act may help lower their out-of-pocket drug costs. As part of that effort, today, HHS added 50 state-by-state infographics plus DC and Puerto Rico that are accessible on LowerDrugCosts.gov by clicking on the interactive map. These new, plain language infographics are meant to assist with continuing education and outreach on the new benefits made available through the Inflation Reduction Act.”
  • Beckers Hospital Review reports,
    • “PatientRightsAdvocate.org report from Feb. 29 found that just 689 (34.5%) of 2,000 hospitals it examined were fully compliant with federal price transparency rules. 
    • “That is down from 721 (36%) that were found to be fully compliant from the organization’s last report, released in July.” 

From the Food and Drug Administration (FDA) front,

  • The AHA News relates,
    • “The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19. The OSOM Flu SARS-CoV-2 Combo Home Test is authorized for use to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens from people aged 14 and older when conducted at least twice over three days with at least 48 hours between tests. 
    • “In other news, the FDA last week recommended health care providers monitor patients with the Hintermann Series H3 Total Ankle Replacement system for potential device failure, and patients with certain implantable BioZorb breast tissue markers for potential serious complications.” 
  • eMPR notes,
    • “The Food and Drug Administration (FDA) has approved Rybrevant (amivantamab-vmjw) in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.”

From the public health and medical research front,

  • The New York Times reports,
    • “Alcohol-related liver disease is the leading cause of death from excessive drinking — and while it’s curable in the earliest stages, many people don’t realize they have it until it’s too late to reverse.
    • “Annual deaths caused by the disease are on the rise in the United States, having climbed 39 percent in recent years, according to new data from the Centers for Disease Control and Prevention. Death rates are highest in men and adults aged 50 to 64, though they are increasing more quickly among women and younger adults.
    • “People who are drinking are drinking more heavily than they were before, so I think that is the biggest factor,” said Dr. Jessica Mellinger, an assistant professor of gastroenterology and hepatology at the University of Michigan Medical School. And, she added, “we’re seeing that for the first time in this country, women are drinking as much as men.”
  • The American Medical Association tells us what doctors wish their patients knew about nutrition, which encourages patients to limit alcoholic beverage intake.
  • STAT News lets us know,
    • “Having Covid-19 increases a person’s risk of developing an autoimmune disease in the year after infection, a large study out of South Korea and Japan reports, but vaccination helps decrease that risk.
    • “Researchers used the medical records of 10 million Korean and 12 million Japanese adults to see whether those who had Covid were more likely to be diagnosed with autoimmune inflammatory rheumatic diseases, or AIRDs, in the year following infection. AIRDs include rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, mixed connective tissue disease, vasculitis, and other conditions. The Covid group was compared with an uninfected control group and a group of patients who had influenza during the same period from 2020 to 2022.”
  • The National Institutes of Health Director, in her blog, relates,
    • “We’re living in an especially promising time for biomedical discovery and advances in the delivery of data-driven health care for everyone. A key part of this is the tremendous progress made in applying artificial intelligence to study human health and ultimately improve clinical care in many important and sometimes surprising ways. One new example of this comes from a fascinating study, supported in part by NIH, that uses AI approaches to reveal meaningful sex differences in the way the brain works.
    • “As reported in the Proceedings of the National Academy of Sciences, researchers led by Vinod Menon  at Stanford Medicine, Stanford, CA, have built an AI model that can—nine times out of ten—tell whether the brain in question belongs to a female or male based on scans of brain activity alone. These findings not only help resolve long-term debates about whether reliable differences between sexes exist in the human brain, but they’re also a step toward improving our understanding of why some psychiatric and neurological disorders affect women and men differently.”
  • Per BioPharma Dive,
    • “The effects of an experimental medicine for a common liver disease strengthened with time in a clinical trial, giving the drug’s developer, Akero Therapeutics, a chance to rebound from a setback last year.
    • “Akero previously said the trial hit its main goal. After six months of treatment, 39% of patients with metabolic dysfunction associated steatohepatitis on a low dose of the drug and 41% on a high dose had a meaningful reduction in liver scarring and no worsening of their disease, versus 20% of placebo recipients. New results disclosed Monday show that 75% of those on a high dose and 46% on a low dose hit that mark after two years, compared to 24% of placebo patients.
    • “The most common side effects associated with treatment were mild-to-moderate cases of diarrhea, nausea and increased appetite. The 15 serious adverse events reported were “generally balanced across dose groups,” though Akero didn’t provide specifics. Three patients on the high dose stopped treatment.”

From the U.S. public health front,

  • CNBC and Fierce Healthcare bring us to date on the Change Healthcare situation. Of note,
    • “As a growing number of groups put pressure on the administration, the White House is reportedly considering short-term financial relief to support hospitals navigating the fallout of the cyberattack against Change Healthcare.
    • “The news was first reported by Politico and attributed to an anonymous senior administration official. In a series of recent meetings at the deputy level, the White House’s National Security Council reportedly discussed options that would not require support from Congress. Instead, it is exploring ways to tap into funding programs overseen by Health and Human Services, the Center for Medicare & Medicaid Services and the Department of Veterans Affairs to support healthcare organizations.
    • “This cashflow issue has been at the forefront since the beginning of last week for us,” the senior administration official told Politico. The agency is also reportedly pushing UnitedHealth Group to provide more transparency about when it can restore Change systems.
    • “The Biden administration is also considering whether to declare the hack a “significant cyber incident,” a rarely used designation that would trigger a special crisis management playbook, according to media reports.”
  • The Wall Street Journal adds these tidbits about the impending launch of Perigo’s over the counter female contraceptive pill called Opill.
    • “Dublin-based Perrigo has shipped its Opill to major U.S. retailers and expects it to be widely available by the end of the month. The company said it would sell a one-month pack for $19.99 and a three-month pack for $49.99.
    • “Opill, which uses the hormone progestin to suppress ovulation, was shown to be 98% effective at preventing pregnancy when used as directed, beating out other over-the-counter methods such as condoms and spermicide. Other prescription methods that require a doctor’s visit, such as intrauterine devices, are more effective. * * *
    • “The drugmaker wouldn’t confirm which stores will carry its product, but said all major retailers and online marketplaces would sell it. Pharmacy giant Walgreens is advertising the pill as “coming soon” on its website.
    • “Perrigo will also sell its product on its website, including a six-month pack for $89.99. The company said it would ship the pills in discreet packaging to online buyers.”
  • Becker’s Hospital Review identifies twelve U.S. health systems with strong finances.
  • The FEHBlog tried to keep readers abreast of noteworthy business announcement from last week’s VIVE conference. MedCity News helpfully lists nine of them.

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec informs us,
    • “President Biden on Thursday nominated former Labor Department Secretary Marty Walsh to serve on the U.S. Postal Service board of governors, potentially giving the administration more representation in supervising the mailing agency. 
    • “Walsh, a former Democratic mayor of Boston, would fill one of two vacancies currently open on the governing board. His nomination comes at a pivotal moment for the Postal Service, which, under the leadership of Postmaster General Louis DeJoy, is in the midst of a complete overhaul of the agency’s operations, staffing and pricing strategies. It follows a call earlier this month from dozens of House Democrats who pushed Biden to fill the vacancies to ensure increased oversight of DeJoy’s reforms. * * *
    • “The former secretary’s confirmation would give Biden his sixth nominee to sit on the board that has nine presidentially appointed, Senate-confirmed slots. Lee Moak and Bill Zollars both saw their terms expire in December and their seats have been vacant ever since. Walsh would be the fourth Democrat to sit on the board, joining three Republicans and one independent. Federal statute requires no more than five members of the board be of the same party, meaning Biden could choose another Democrat to fill the remaining vacancy.” 
  • Federal News Network discusses OPM’s February 8, 2024, call letter to FEHB and PSHB carriers for 2025 FEHB and PSHB benefit and rate proposals.
  • Bloomberg tells us that a federal judge in Delaware has thrown out Astra-Zeneca’s constitutional and statutory challenge to the government drug price negotiation provisions of the Inflation Reduction Act.
    • “Because AstraZeneca’s participation in Medicare is not involuntary, AstraZeneca does not have a protected property interest in selling drugs to the Government at prices the Government will not agree to pay. Accordingly, AstraZeneca’ s due process claim fails as a matter of law,” the judge wrote.
    • “Among other cases, Connolly pointed to Dayton Area Chamber Commerce v. Becerra on how “participation in the Medicare program is a voluntary undertaking,” and neither the Inflation Reduction Act nor any other federal law requires AstraZeneca to sell its drugs to Medicare beneficiaries.” * * *
    • “AstraZeneca’s loss is another setback for the pharmaceutical industry among the lawsuits challenging the program. A federal judge in Texas dismissed Nat’l Infusion Ctr. v. Becerra for lack of jurisdiction, and a federal judge in Ohio struck down a preliminary injunction that would have halted the program.
    • “Similar suits brought by manufacturers and industry groups are pending for Johnson & Johnson, Bristol Myers Squibb & Co., Novo Nordisk A/S, Novartis AG, Merck & Co., Boehringer Ingelheim, and the Dayton Area Chamber of Commerce in Ohio.
    • “The case is AstraZeneca Pharm. LP v. Becerra , D. Del., No. 1:23-cv-00931, memorandum opinion 3/1/24 .”
  • The Wall Street Journal reports,
    • “Pharmacy chains CVS and Walgreens will begin dispensing mifepristone, commonly known as “the abortion pill, in coming weeks.
    • The two chains said Friday they received certification to dispense the pills, following a regulatory shift last year to allow bricks-and-mortar pharmacies to offer the pill with a prescription.
    • “The companies said they would distribute the pill in a way consistent with state laws—meaning it won’t be offered in states that don’t allow legal access to abortion through 10 weeks—and will begin rolling out the pill in a handful of states. Both said they wouldn’t make mifepristone available via mail order. The drug is already available via other mail-order pharmacies and telehealth platforms.”
  • According to MedTech Dive,
    • “Boston Scientific said Friday it has received Food and Drug Administration approval for a drug-coated balloon to treat coronary in-stent restenosis, a condition in which a vessel that previously received a stent narrows again due to plaque or scar tissue.
    • “Approval for the device, which received FDA’s breakthrough designation in 2021, was supported by positive results from the prospective, randomized Agent trial that enrolled 600 patients at 40 U.S. sites, the company said.
    • “We view Agent highly favorably for its statistically significant superiority in what is a difficult-to-treat and common [in-stent restenosis] patient population, which we think could enable rapid physician adoption,” BTIG analyst Marie Thibault wrote Friday in a note to clients.”

From the public health and medical research front,

  • The Centers for Disease Control relates,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 27 jurisdictions experienced high or very high activity. This number remains stable compared to last week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity decreased nationally but is increasing in the Central region (including Iowa, Kansas, Missouri, and Nebraska). COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflect both symptomatic and asymptomatic infections, remain at high levels, particularly in the South, but are trending downward.”
  • and more specifically with regard to Covid,
    • “As the 2023-2024 fall and winter virus season ends, it’s clear that the situation surrounding COVID-19 has changed.  It is still an important health threat, but it is no longer the emergency that it once was, and its health impacts increasingly resemble those of other respiratory viral illnesses, including flu and RSV.
    • “CDC released updated Respiratory Virus Guidance in response to the decreasing risk that COVID-19 poses to the population. This updated Guidance includes strategies to protect people at highest risk of getting seriously ill and provides actionable recommendations for people with common viral respiratory illnesses, including COVID-19, flu, and RSV.
    • “Keep reading: CDC’s Updated Respiratory Virus Guidance: What to do When You Are Sick.”
  • The New York Times adds,
    • Americans with Covid or other respiratory infections need not isolate for five days before returning to work or school, the Centers for Disease Control and Prevention said on Friday, a striking sign of changing attitudes toward the coronavirus.
    • People with respiratory illnesses may resume daily activities if they have been fever-free for at least 24 hours without the aid of medications and if their symptoms are improving, agency officials said. 
    • Acknowledging that people can be contagious even without symptoms, the C.D.C. urged those who end isolation to limit close contact with others, wear well-fitted masks, improve indoor air quality and practice good hygiene, like washing hands and covering coughs and sneezes, for five days.
    • The guidelines apply to Covid, influenza and respiratory syncytial virus, among other respiratory ailments, which should make it easier for people to comply, Dr. Mandy Cohen, the C.D.C.’s director, told reporters on Friday.
  • MedPage Today notes,
    • “Early estimates suggest flu shots are performing OK in the current U.S. winter flu season.
    • “The vaccines were around 40% effective in preventing adults from getting sick enough from the flu that they had to go to a doctor’s office, clinic, or hospital, health officials said during a CDC vaccines meeting Wednesday. Children who were vaccinated were roughly 60% less likely to get treatment at a doctor’s office or hospital, they noted.
    • “Officials generally are pleased if a flu vaccine is 40% to 60% effective.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health have identified antibodies targeting a hard-to-spot region of the influenza virus, shedding light on the relatively unexplored “dark side” of the neuraminidase (NA) protein head. The antibodies target a region of the NA protein that is common among many influenza viruses, including H3N2 subtype viruses, and could be a new target for countermeasures. The research, led by scientists at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center, part of NIH, was published today in Immunity.” * * *
    • “These findings show that the NA dark side has unique, previously untapped epitopes that could be applied to the development of new vaccine and therapeutic strategies. They suggest that antibodies targeting the NA dark side could be useful in combination with antivirals or other types of antibodies for interventions against influenza, as they are effective against influenza viruses with drug-resistant mutations. The researchers also note that NA dark side targets could be included in the next generation of broadly protective vaccines against influenza.”
  • Per BioPharm Dive,
    • “Advisers to the Centers for Disease Control and Prevention are weighing updates to their recommendation older adults get vaccinated for respiratory syncytial virus, discussing changes at a meeting Thursdaythat would more forcefully encourage some individuals receive a shot.
    • “At the meeting, the Advisory Committee on Immunization Practices reviewed safety and efficacy data on RSV vaccines sold by GSK and Pfizer, as well as clinical trial data for an experimental shot from Moderna that’s nearing market.
    • “Currently, the CDC recommends adults 60 years or older discuss RSV vaccination with their physician — a process known as “shared clinical decisionmaking.” Advisers debated whether, for some individuals at higher risk, a universal recommendation would be more appropriate. They wanted more data before making a decision, however, likely at a follow-up meeting scheduled for June 26 to June 28.”

From the U.S. healthcare business front,

  • Crains Grand Rapids [Mich.] Business reports,
    • “Perrigo Co. plc expects to introduce the first oral contraceptive available in the U.S. without a physician’s prescription by mid March. 
    • “The company has “activation plans” in place to promote and drive consumer awareness of Opill at retail stores and for online sales when it goes to market, said President and CEO Patrick Lockwood-Taylor. 
    • “We expect Opill to be available to consumers in-store and online within a few weeks,” Lockwood-Taylor said during a Tuesday morning conference call to discuss Perrigo’s latest quarterly results. “You’ll find it in every store, and you’ll find it everywhere online.” 
  • Beckers Hospital Review lets us know,
    • “Cleveland Clinic posted an operating income of $64.3 million in 2023 after posting a $211.3 million loss in 2022, according to its financial report released Feb. 29. 
    • “The health system had a 0.4% operating margin for the year ended Dec. 31 after posting a -1.6% margin in 2022, according to the report. 
    • “Cleveland Clinic said the improved operating performance was driven by an 11.4% increase in operating revenues, “supported by strong patient demand for both inpatient and outpatient services, that outpaced a 9.1% increase in operating expenses in 2023 compared to 2022.”
    • “The system had a total operating revenue of $14.5 billion and total operating expenses of $13.7 billion in 2023. Cleveland Clinic said the growth in expenses was primarily driven by higher patient volumes and inflationary trends that increase salaries, wages and benefits, supply expenses and pharmaceutical costs.” 
  • According to BioPharma Dive,
    • “Pfizer believes the answer to its sliding valuation lies in oncology. 
    • “The company, which is coming off one of the worst years in its history, unveiled on Thursday a new business unit dedicated to cancer research. The division, created in the wake of Pfizer’s $43 billion buyout of Seagen last year, houses a sprawling portfolio of experimental medicines both companies discovered and acquired through deals. It also includes the marketed drugs Pfizer and Seagen have long been selling for a variety of tumor types. 
    • “Pfizer claims the pipeline it now has could produce more than eight blockbuster medicines by 2030, up from five today, and double the number of patients the company’s drugs currently treat. By then, biologic medicines should account for nearly two-thirds of its oncology revenue, up substantially from the 6% they comprise now, Pfizer said. 
    • “To achieve those goals, Pfizer will need steady sales growth and additional approvals for its currently marketed medicines. It will also need a pipeline of 16 experimental drugs across four broad areas of cancer research to come through in testing.” 

Monday Roundup

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

From Washington, DC,

  • The Wall Street Journal reports,
    • “President Biden is calling congressional leaders to the White House as the clock ticks toward a partial government shutdown Friday night and a Ukraine aid package remains stuck.
    • “The president has called the meeting for Tuesday, seeking to break a logjam. House and Senate leaders have been working to negotiate the details of 12 funding bills totaling $1.6 trillion for federal agencies, which have been operating on temporary extensions since Sept. 30. Funding for the Transportation Department and several other agencies expires after March 1, which would affect some housing, food and veterans’ programs; the rest expires after March 8.” 
  • STAT News reports,
    • “Congress has abandoned its attempt to reform how pharmacy middlemen operate in an upcoming package to fund the federal government, 11 lobbyists and sources following the talks told STAT.”
  • and
    • “Congress will not move forward with a controversial policy to equalize certain Medicare payments to hospitals and physicians’ offices in an upcoming government funding package, five lobbyists and sources following the talks told STAT.”
  • From an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $36.9 million in notices of funding opportunities for grant programs supporting behavioral health services across the country. Additionally, HHS, through the Centers for Medicare & Medicaid Services (CMS), issued guidance that allows states to expand the pool of behavioral health care providers eligible for enhanced federal Medicaid funding, which will better support this critical workforce as well as improve access to care. The guidance also allows states to claim federal dollars for nurse advice lines.”
  • BioPharma Dive tells us,
    • “The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most popular version of AbbVie’s rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected by the FDA twice before due to manufacturing issues at a plant in Iceland.
    • “The partners didn’t announce a launch date or a price for Simlandi, which will be the 10th Humira biosimilar reach market since Amgen’s Amjevita arrived on Jan. 31, 2023. Some biosimilars have launched at a steep upfront discount while others have a list price only slightly below Humira’s to allow for negotiation over rebates.
    • “Alvotech also announced a stock sale Monday, raising around $166 million at $16.41 a share. The company had $68 million in cash and equivalents on Sept. 30, after recording losses of $275 million on $30 million in revenue through the first nine months of 2023.”
  • HR Dive informs us,
    • “A federal district court has delayed a National Labor Relations joint employer rule effective date to March 11. Friday marks the second time the start date has been delayed; NLRB previously extended a Dec. 26, 2023, start date to Feb. 26.
    • “This new rule establishes a standard for determining if two organizations are joint employers of particular employees; two entities are joint employers when they co-determine the essential terms of an individual’s employment.”
  • The Census Bureau issued a tip sheet on grandparents and co-resident grandchildren 2021.
    • “According to the 2017-2021 ACS, 5-year estimates, 8.0% of children under age 18 lived in their grandparents’ home.
    • “The proportion of children living with only their grandparents or with their grandparents and one or both parents varied across race and ethnicity. For grandchildren who lived with grandparents, it was more common to also live with both parents or their mother in the household than to live with their father or no parent in the household.
    • “Overall, about 38.6% of children under age 18 who lived with grandparents also lived with two parents. Of all race and Hispanic origin groups, Asian grandchildren had the highest percentage (70.9%) in this living arrangement.
    • “About 16.2% of grandchildren under age 18 living with grandparents were in poverty. The percentage was higher for those in grandparent-maintained households (18.6%) compared to parent-maintained households (12.1%).
    • “About 76.1% of all grandchildren under age 18 living with grandparents lived in households that received public assistance, most commonly through the school lunch program.”
  • The tip sheet drew the FEHBlog’s attention due to FEHB coverage of foster children.
  • Health Reform Beyond the Basics offers an an explanation of the ACA Summary of Benefits and Coverage

From the public health and medical research front,

  • The New York Times offers a 2024 guide to COVID symptoms and treatments.
  • CNN points out,
    • “Cases of norovirus are on the rise in the US, on par with seasonal trends, according to the most recent data from the US Centers for Disease Control and Prevention.
    • “In the week ending February 17, more than 12% of tests for norovirus – a common and very contagious virus that causes gastrointestinal symptoms – came back positive, CDC data showed. That’s up from 11.5% the week before. Cases are particularly high in the Northeast, where more than 13% of tests came back positive. Positivity rates in the region have been over 13% since late January.
    • “However, these levels are below what they were at this point last season, when about 15% of tests were positive, both nationally and in the Northeast.
    • “Outbreaks of norovirus are most common in the late fall, winter and early spring, according to the CDC.”
  • HR Daily Advisor identifies eight tips to help employees improve mental health in the face of the winter blues.
  • Medscape lets us know that “Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.”
  • The National Institutes of Health announced,
    • “Results from a large clinical trial funded by the National Institutes of Health show that an intervention for anxiety provided to pregnant women living in Pakistan significantly reduced the likelihood of the women developing moderate-to-severe anxiety, depression, or both six weeks after birth. The unique intervention was administered by non-specialized providers who had the equivalent of a bachelor’s degree in psychology—but no clinical experience. The results suggest this intervention could be an effective way to prevent the development of postpartum mental health challenges in women living in low-resource settings.
    • “In low resource settings, it can be challenging for women to access mental health care due to a global shortage of trained mental health specialists,” said Joshua A. Gordon, M.D., Ph.D., Director of the National Institute of Mental Health, part of NIH. “This study shows that non-specialists could help to fill this gap, providing care to more women during this critical period.”
    • “Led by Pamela J. Surkan, Ph.D., Sc.D.(link is external), of Johns Hopkins Bloomberg School of Public Health, Baltimore, the study was conducted in the Punjab Province of Pakistan between April 2019 and January 2022. Pregnant women with symptoms of at least mild anxiety were randomly assigned to receive either routine pregnancy care or a cognitive behavioral therapy (CBT)-based intervention called Happy Mother-Healthy Baby. The researchers assessed the participants (380 women in the CBT group and 375 women in the routine care group) for anxiety and depression six weeks after the birth of their child.
    • “The researchers found that 9% of women in the intervention group developed moderate-to-severe anxiety compared with 27% of women in the routine care group. Additionally, 12% percent of women in the intervention group developed depression compared with 41% of women in the routine care group.”
  • According to BioPharma Dive,
    • “An experimental obesity drug from Boehringer Ingelheim and Zealand Pharma succeeded in a mid-stage liver disease study, the latest evidence new weight loss medicines could also help people with metabolic dysfunction-associated steatohepatitis, or MASH.
    • “Summary results disclosed Monday show that up to 83% of trial participants treated with the companies’ drug, survodutide, experienced a significant improvement in their disease without worsening liver scarring, compared to about 18% of those given placebo. The drug met its secondary study goals, notably demonstrating a benefit on liver scarring, the companies said.
    • “Boehringer and Zealand didn’t provide many other details, leaving unanswered questions about the magnitude of survodutide’s effect. The companies also didn’t describe safety findings in depth, although they noted treatment “did not show unexpected safety or tolerability issues” at any of the three doses tested. Data will be presented at an upcoming medical meeting.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Elevance Health’s CarelonRx will begin offering a weight management program, providing its members access to digital-first coaching and wellness tools.
    • “Behavioral health and social drivers of health screenings will be included in the offerings, according to a news release. The program will help members that take, as well as those that don’t take, GLP-1 medications. It will be available to ASO-integrated clients.
    • “At CarelonRx, we want to ease the complexities of weight loss and weight management, and support healthier lifestyles for our members,” said Paul Marchetti, president of CarelonRx, in a statement. “Our weight management program is unique because it considers a member’s whole health needs, including pharmacy, medical and social drivers of health data, and creates opportunities for care coordination between nutrition and exercise experts, pharmacists, physicians and health plans.”
  • and
    • “Humana tapped data automation company Veda to improve the accuracy of its provider information and ensure seniors have real-time details about in-network providers. The partnership was announced at the ViVE 2024 conference Monday morning. * * *
    • “Founded in 2015, Veda developed an AI platform that enables payers to transform and ingest provider rosters rapidly, reducing turnaround times from weeks to hours, according to the company.
    • “Veda will use its patented automation technology to analyze, verify and standardize Humana’s data to ensure the information is accurate and comprehensive, along with real-time scoring of data quality.
    • “Accurate provider data is a key component of efficient health plan operations, care delivery, interoperability, and ultimately patient satisfaction,” Meghan Gaffney, Veda co-founder and CEO, said. “By addressing the challenges that members may face with finding in-network care providers, Humana is ensuring their members have access to the timely, high-quality care they deserve.”  
    • “Veda says its platform achieves high data accuracy, ensuring quality across networks as measured by the Centers for Medicare & Medicaid Services (CMS).”
  • and
    • “The cybersecurity incident at Change Healthcare will stretch on for at least another day, according to the latest update from Optum.
    • “The company posted early Monday morning that it is taking multiple angles to get Change’s systems back online, and stressed that it has a “high level of confidence” that other systems within Optum, UnitedHealthcare and UnitedHealth Group are unaffected. * * *
    • “In a statement to CNBC, CVS Health said that while it is continuing to fill prescriptions for customers, it’s not able to process all of its insurance claims. The pharmacy giant added that there is “no indication” that its own systems have been breached.”
  • Reuters notes,
    • “Pharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry’s embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found.
    • “The median annual list price for a new drug was $300,000 in 2023, according to the Reuters analysis of 47 medicines, up from $222,000 a year earlier. In 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published in JAMA.”
  • The Society for Human Resource Management relates,
    • “Millions more employees than expected are leaving the workplace in favor of retirement—a phenomenon that stands to have an outsized impact on employers.
    • “The U.S. currently has roughly 2.7 million more retirees than predicted, Bloomberg reports, according to a model designed by an economist at the Federal Reserve Bank of St. Louis. That’s up 80 percent from six months ago, when there were roughly 1.5 million more retirees than anticipated. By contrast, prior to the pandemic, there often were fewer retirees than expected.”

Thursday Miscellany

David Ermer–Congress, FDA, HSA, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • American Hospital Association (AHA) News reports,
    • “AHA Feb. 22 voiced support for the Child Suicide Prevention and Lethal Means Safety Act (H.R. 7265), legislation that would provide funding for training programs to help health care workers identify patients at high risk for suicide or self-harm. The bill would also provide grants to facilitate suicide prevention training at health professions schools.”  
  • and
    • “Senate Health, Education, Labor & Pensions Committee Ranking Member Bill Cassidy, R-La., Feb. 21 released a report proposing ways to modernize the existing HIPAA framework and protect health and other data not covered by HIPAA. Responding to Cassidy’s request for information on the issue last year, AHA asked Congress to urge the Department of Health and Human Services’ Office for Civil Rights to immediately withdraw a rule that would violate HIPAA and its implementing regulations; explore how to better require entities not covered by HIPAA to protect patient privacy; and strengthen HIPAA preemption.”
  • Roll Call tells us,
    • “The House Democratic Women’s Caucus has asked the biggest insurance association to urge insurers to comply with contraceptive coverage requirements and Biden administration guidance issued in January, according to a letter shared first with CQ Roll Call. * * *
    • “The Democratic Women’s Caucus wrote to AHIP President and CEO Mike Tuffin on Thursday urging the group to have its members follow the suggestions HHS outlined. 
    • “Despite repeated clarification of these requirements from the Departments, multiple investigations — including by the House Oversight Committee — have revealed that plans routinely violate the [2010 health care law] by refusing to cover certain products, imposing administrative hurdles like prior authorizations and step therapy (fail first protocols), and requiring patient cost-sharing,” wrote the 143 House members as well as 13 senators.
    • “The members asked Tuffin to respond if insurance plans will be adopting the standard and when; how plans that will not adopt the standard intend to comply with the coverage requirement and if any member plans have been using techniques to deny coverage as described in the HHS guidance. 
    • “The letter also seeks clarity on which plans have an exceptions process publicly available on their websites for when a therapeutically equivalent product does not work for a patient.
    • “The letter requests a response by March 1.”
  • MedTech Dive notes,
    • Better Therapeutics has received breakthrough device status for a digital therapeutic designed to treat adults with advanced liver disease, the company said Tuesday.
    • The Food and Drug Administration awarded the designation after seeing the results of a clinical trial that linked the digital cognitive behavioral therapy (CBT) to reductions in liver fat.
    • Better Therapeutics won FDA authorization in Type 2 diabetes in July but, like the wider digital therapeutics sector, has struggled to allay concerns about commercialization. The company has discussed substantial doubts about its ability to continue as a going concern. 
  • Mercer Consulting projects “the 2025 inflation-adjusted amounts for health savings accounts (HSAs), high-deductible health plans (HDHPs) and excepted-benefit health reimbursement arrangements (HRAs) will all rise from 2024 levels. These unofficial 2025 amounts are determined using the Internal Revenue Code (IRC)’s cost-of-living adjustment methods, the US Bureau of Labor Statistics (BLS) published Chained Consumer Price Index for All Urban Consumers (C-CPI-U) values through January 2024, and Mercer’s projected C-CPI-U values for February and March.”
  • “The U.S. Preventive Services Task Force posted today a final research plan on screening for HIV. The draft research plan for this topic was posted for public comment from November 30, 2023, to January 3, 2024. The Task Force reviewed all of the comments that were submitted and took them into consideration as it finalized the research plan. To view the final research plan, please go here.”

From the public health and medical research front,

  • MedPage Today calls our attention to the following
    • “More than 134,000 cancers might have gone undiagnosed during the first 10 months of the COVID-19 pandemic, according to a study of national trends in cancer incidence.
    • “Annual cancer incidence fell almost 30% short of the expected rate from March through December 2020. The difference represented potentially 134,395 undiagnosed cancers during that period. Diagnosis of early- and late-stage cancers declined. Prostate, breast, and lung cancers accounted for the most potential missed cases. Overall, rates of “screenable” cancers decreased by 13.9% versus expected rates. * * *
    • “It is important that we continue to evaluate the trends identified in this study as U.S. cancer incidence data for years after 2020 become available,” the authors wrote. “Pandemic-associated disruptions will continue to affect rates of cancer incidence, and how long it will be until we fully recover is still unknown.”
    • “Beyond incidence, it is important that we measure the pandemic’s contribution to future trends in cancer mortality and survival,” they added. “With a near 10% reduction from expected rates in overall late-stage incidence from March to December 2020, there will undoubtedly — and unfortunately — be a subsequent rise in cancer mortality. How substantial a rise and for how long will provide a more complete picture of the consequences of COVID-19 disruptions on the burden of cancer in the U.S.”

The Wall Street Journal reports that “There’s No Easy Way to Stop Taking Ozempic. Those who go off weight-loss drugs risk regaining weight, but staying on them forever isn’t always a realistic option.” Quite a conundrum. The article discusses approaches to stopping the medicine and alternatives, such as bariatric surgery.

  • The National Institutes of Health announced,
    • “A research project supported by the National Institutes of Health has developed a tool to rapidly and inexpensively diagnose sarcoidosis, a chronic inflammatory disease marked by the growth of tiny lumps called granulomas in the lungs and other organs in the body. The tool, which uses a simple blood test, could allow for selective use of more invasive diagnostic tests often used to identify the disease. The findings published in the American Journal of Respiratory and Critical Care Medicine.
    • “Currently, diagnosing sarcoidosis isn’t a straightforward process, and requires tissue removal and testing with additional screenings to rule out other diseases, such as tuberculosis or lung cancer,” said James Kiley, Ph.D., Director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute, part of NIH. “Using a blood test will help diagnose faster, particularly in those organs that are more challenging to biopsy and with less harm to the patient.”
  • The NIH Director, in her blog discusses “A Potential New Way to Prevent Noise-Induced Hearing Loss: Trapping Excess Zinc.”
    • “Hearing loss is a pervasive problem, affecting one in eight people aged 12 and up in the U.S.1 While hearing loss has multiple causes, an important one for millions of people is exposure to loud noises, which can lead to gradual hearing loss, or people can lose their hearing all at once. The only methods used to prevent noise-induced hearing loss today are avoiding loud noises altogether or wearing earplugs or other protective devices during loud activities. But findings from an intriguing new NIH-supported study  exploring the underlying causes of this form of hearing loss suggest it may be possible to protect hearing in a different way: with treatments targeting excess and damaging levels of zinc in the inner ear.”
  • STAT News points out “Embryo loss is integral to [in vitro fertilization] IVF. [The] Alabama ]Supreme Court]’s ruling equating embryos with children jeopardizes its practice.” For more information, listen to this Advisory Opinions podcast from the Dispatch.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Fourteen organizations representing providers, payers, consumer technology companies and employers are teaming up to cut through the noise and raise higher standards for finding digital health solutions that work and are worth the investment.
    • “The new Digital Health Collaborative, supported by the Peterson Health Technology Institute, brings together provider groups, purchasers and end users and initial work will focus on pulling together a national purchaser survey, grantmaking and convenings, the organization said.
    • “The Peterson Health Technology Institute formed in July 2023, armed with $50 million in funding, to evaluate digital health technologies and help cut through the hype to identify innovations that actually benefit patients. PHTI focused on providing independent, evidence-based assessments of emerging products, something that is currently lacking in the market.”
  • BioPharma Dive tells us,
    • “Moderna shares rose by as much as 10% Thursday morning after the COVID-19 vaccine developer reported fourth quarter profit that beat Wall Street expectations of a net loss during the final three months of 2023.
    • “Full-year sales of $6.7 billion matched estimated numbers Moderna disclosed in January, but were down by about two-thirds versus 2022 as COVID vaccination rates declined substantially last year. The company has restructured its manufacturing operations in response to match the lower demand.
    • “Moderna forecasts $4 billion in sales this year, with some expected to come from an experimental vaccine for respiratory syncytial virus that’s under regulatory review in the U.S. and several other countries.”
  • McKnight’s Long Term Care News lets us know,
    • “A shortage of registered nurses in the first two years of the pandemic was probably temporary, according to a new report. That’s because the workforce rebounded in 2022 and 2023, the authors said. Even still, a lot of RNs aren’t going back to hospitals and are moving into other settings including nursing homes and long-term care communities, authors of the report said.
    • “The study, published on Feb. 16 in JAMA Health Forum, noted that the workforce of RNs fell by about 100,000 employees in 2021. That decrease was the largest drop in a single year in the past 40 years. In 2022, hiring started to go back up, according to data from the US Bureau of the Census Current Population Survey. 
    • “The data included RNs between the ages of 23 and 69 who were employed between 1982 and 2023. The researchers also used another cohort of data on employment trends by birth year and age to project the age distribution and employment of RNs through the year 2035. There were 455,085 RNs included in the study. In 2022 and 2023, there were 3.35 million full-time RNs, which is 6% higher than in 2019 when there were 3.16 million nurses.”
  • Per Healthcare Dive,
    • “Walgreens is planning to close its remaining VillageMD clinics in Florida as the beleaguered retail giant continues to cut costs.
    • “VillageMD operated 52 clinics in Florida, but 14 have closed to date. The remainder will shutter by March 15, according to multiple news reports citing Walgreens. The closures fully exit VillageMD from Florida, one of its largest markets and a key target for value-based primary care chains given the state’s large population of elderly patients with chronic health needs.
    • “Walgreens did not share details of what’s driving the closures. But analysts say Walgreens may have struggled getting enough doctors and patients into the smaller clinics, which are co-located within Walgreens stores.”
  • Beckers Hospital News notes,
    • “Grubhub has teamed up with CVS Pharmacy to deliver health and wellness products to consumers in 48 states. 
    • “Grubhub users can now access thousands of products on the mobile ordering and delivery platform from more than 6,000 CVS locations nationwide. * * *
    • “CVS is the second national drugstore chain to partner with Grubhub, behind Rite Aid. Walgreens has also teamed up with Doordash and Uber to deliver medications and other health products.”
  • Per HR Dive,
    • “Business advocates and the U.S. Department of Labor can resume their fight over independent contractor regulations, the 5th U.S. Circuit Court of Appeals decided Monday (Coalition v. Su).
    • “The litigation began after the Biden administration in 2021 nixed a Trump-era rule on the issue. Business groups challenged that withdrawal, arguing DOL overstepped its authority. A federal district court judge agreed, and the Biden administration appealed that ruling to the 5th Circuit. The appeals court issued a stay pending DOL’s publication of a new rule.
    • “Biden’s DOL finalized its own version of the regulations in January, with a March 11 effective date, leading the 5th Circuit to lift its stay Monday at the request of the business groups. The court also vacated the lower court’s opinion at DOL’s request, sending it back for the court to revisit.
    • “Considering this and other litigation related to the new regulations, a court could very well put the upcoming rules on hold, an employment law attorney told HR Dive last month; but with the effective date just weeks away, employers should monitor developments closely, he said.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, Medical / Rx research, Mental health care, NIH, No Surprises Act, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Beckers Health IT informs us,
    • “U.S. lawmakers introduced bipartisan legislation Feb. 16 to better match patients with their EHRs.
    • “U.S. Reps. Mike Kelly, R-Pa., and Bill Foster, PhD, D-Ill., sponsored the Patient Matching and Transparency in Certified Health IT, or MATCH IT, Act of 2024.
    • “Patient matching errors have led to unnecessary expenses, medical mistakes, and even patient deaths,” Mr. Kelly said in a Feb. 16 news release. “This bipartisan legislation works to improve interoperability between healthcare systems and decrease these fixable matching errors, all while protecting patient privacy.”
  • STAT News tells us,
    • “Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. The therapy, called Amtagvi or lifileucel from Iovance, is the first cell therapy approved for a solid tumor.
    • “It’s so exciting and gratifying,” said Allison Betof Warner, a cell therapy researcher and physician at Stanford University who has worked on Amtagvi. “This is a game-changing moment for our field. We’ve seen huge success of cellular therapy for hematologic malignancies, and we’ve yet to capitalize on that for solid tumors. This is hopefully the first of many to come.”
    • “In a Phase 2 clinical trial, titled C-144-01, 153 patients who had already been on a median of three prior lines of therapy received lifileucel, and 31% of them responded to therapy. “These are in very late line patients. They’ve exhausted every standard care option,” Betof Warner said. “The most promising part of this therapy for me is that 42% of patients who responded were still responding for 18 months or longer. It’s truly incredible.”
    • “The therapy is not expected to work for every patient, partially because the regimen has high toxicity. It will also be expensive. The therapy is expected to be priced at $515,000.”
  • Beckers Hospital Review adds, “Buzz for gene therapies is loud, but drugmakers struggle to get treatments off the ground.”
    • “A major barrier for many companies in the space is sheer cost to develop these advanced medical therapies. Though the Biden administration and CMS announced Jan. 30 plans to bring down prices for gene edited therapies, progress will take time. 
    • “The number of patients being treated with the existing gene therapies that are approved and available on the market is expected to decline year over year by nearly 33%, according to Bloomberg.”
  • Per the Food and Drug Administration,
    • “On Friday, the FDA published an Outbreak Advisory for an investigation of E. coli O157:H7 linked to raw cheddar cheese. The FDA recommends that consumers, restaurants, and retailers do not eat, sell, or serve Raw Farm-brand Raw Cheddar Cheese (block or shredded) and to throw it away. This is an ongoing investigation and the FDA will update the Advisory should additional consumer safety information become available.”
  • BioPharma Dive reports,
    • “AstraZeneca’s targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally advanced or metastatic lung tumor, following a Food and Drug Administration approval Friday.
    • “The FDA cleared Tagrisso together with chemotherapy based on results showing the combination reduced the risk of disease progression or death versus Tagrisso alone, which is currently the first-line standard for non-small cell lung cancer that harbors mutations in a gene known as EGFR.
    • “Over the weekend, meanwhile, AstraZeneca reported new clinical trial data showing Tagrisso outperformed placebo following chemoradiotherapy for Stage 3 EGFR-mutated non-small cell lung cancer that couldn’t be surgically removed. The results, which AstraZeneca will share with regulators, could further support early use of Tagrisso.”

From the public health and medical research front,

  • Axios points out,
    • “More than half of U.S. newborns now appear to be protected by new RSV vaccines, according to updated Centers for Disease Control and Prevention data.
    • “Why it matters: The virus is considered the second leading cause of death worldwide during the first year of a child’s life. The data suggests demand was strong despite broader vaccine skepticism and the potential for confusion over more childhood immunization options.”
  • The Wall Street Journal discusses a related RSV vaccine (Beyfortus) shortage — “A new antibody that protects babies from a deadly virus proved far more popular than drugmaker Sanofi expected.”
    • Beyfortus seller Sanofi in March last year set aggressive targets for how many doses to make, yet still underestimated demand. Some pediatricians delayed ordering immunizations because they didn’t know whether insurers would cover the $495 doses. And the U.S. government decided in August—months after Sanofi had locked in the number of doses it would make—to add the shot to the Vaccines for Children program, a federal initiative that covers children who are uninsured or on Medicaid, buying more than half of the doses.
    • Sanofi said it sought to distribute its shots equitably in the face of “unprecedented” demand and is working to increase supply for the next RSV season. 
  • HHS’s Agency for Healthcare Quality and Research issued a Medical Expenditure Panel Survey about “Characteristics of Young Adults Aged 18-24 Who Had Ever Used an Electronic Nicotine Product, 2021.”
    • “Nearly one-third (30.6 percent) of U.S. adults ages 18-24 reported ever having used an electronic nicotine product.
    • “More than one-third (38.3 percent) of non-Hispanic White young adults reported ever having used an electronic nicotine product, nearly double the rate for Hispanic young adults and 12 percentage points higher than for non-Hispanic Black young adults.”
  • Medpage Today notes,
    • “Nearly all medication abortions obtained via telehealth, whether via video or secure text messaging, were completed without further intervention and without adverse events, the prospective CHAT study found.
    • “Among over 6,000 abortions, 97.7% (95% CI 97.2-98.1) were completed without further intervention, and the completion rate was similar for patients who had video calls (98.3%) or used text messaging (97.4%), reported Ushma Upadhyay, PhD, MPH, of the University of California San Francisco, and colleagues.
    • “Less than 1% of patients had a serious abortion-related adverse event (0.25%) or were treated for an ectopic pregnancy (0.16%), and 1.3% of abortions were followed by emergency department visits, the authors wrote in Nature Medicine.”
  • The FEHBlog has subscribed to a Substack series called “Your Local Epidemiologist.”
    • “Your Local Epidemiologist (YLE)” is written by Dr. Katelyn Jetelina, M.P.H. Ph.D.—an epidemiologist, wife, and mom of two little girls. During the day, she is a senior scientific consultant to several organizations, including CDC. At night, she writes this newsletter. Her main goal is to “translate” the ever-evolving public health world so that people will be well-equipped to make evidence-based decisions. This newsletter is free, thanks to the generous support of fellow YLE community members.”
    • Check it out.
  • Medpage Today offers an expert medical opinion concerning
    • “News surfaced last week suggesting a potential shift in COVID-19 isolation guidanceopens in a new tab or windowfrom the CDC. The planned guidance, which is expected to be released this spring for public comment, indicates a significant switch in how COVID-19 is conceptualized. The guidance would bring COVID-19 into line with how other common respiratory viruses are managed: with isolation recommended until the individual has mild and improving symptoms, and is fever-free (without pharmaceutical aid) for 24 hours.”
    • “With the news of the proposed guidance, many voices rose up to immediately attack the proposed guidance as a capitulation and not evidence-based. This was similar to the refrain from opponents when the federal or state governments dropped or loosened mask requirements or guidance.
    • “I was not one of themopens in a new tab or window.
    • “Indeed, I welcome the proposed guidance change because it reflects the progress that has been made in the management of COVID-19. When evaluating this guidance, it is critical to understand that SARS-CoV-2, the cause of COVID-19, is situated among the myriad respiratory viruses that infect humans.”
  • Medscape lets us know,
    • “Availability of telehealth services for mental healthcare varies widely from state to state, a new study shows. One fifth of all facilities contacted reported no mental telehealth options and wait times for those that did ranged from 4 days to > 2 months, depending on the state.”
  • The National Institutes of Health announced,
    • “To prevent an emerging genomic technology from contributing to health disparities, a scientific team funded by the National Institutes of Health has devised new ways to improve a genetic testing method called a polygenic risk score. Since polygenic risk scores have not been effective for all populations, the researchers recalibrated these genetic tests using ancestrally diverse genomic data. As reported in Nature Medicine, the optimized tests provide a more accurate assessment of disease risk across diverse populations.
    • “Genetic tests look at the small differences between individuals’ genomes, known as genomic variants, and polygenic risk scores are tools for assessing many genomic variants across the genome to determine a person’s risk for disease. As the use of polygenic risk scores grows, one major concern is that the genomic datasets used to calculate the scores often heavily overrepresent people of European ancestry.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “After federal legislation protecting consumers from surprise medical bills was implemented, a growing number of medical claims were in network, according to a new analysis.
    • “The No Surprises Act went into effect on Jan. 1, 2022. From the fourth quarter of 2021 to the first quarter of 2022, in-network care as a percentage of all claim lines nationally increased 2.3%, according to the study by nonprofit Fair Health.
    • “It’s the latest research suggesting No Surprises has been successful in lowering the amount of unexpected out-of-network bills, though the rollout of the law has been tied up in lawsuits, and regulators currently face a backlog of billing disputes between payers and providers.”
  • and
    • “Insurers brace for continued Medicare Advantage medical costs. The big question coming out of the health insurance earnings season is how much elevated utilization among seniors is carrying over into 2024.”
  • EndPoint News points out,
    • “Cigna’s venture unit just made a bet on a startup focused on cardiometabolic conditions that wants to play a role in prescribing GLP-1 medications.
    • “9amHealth said on Tuesday it raised $9.5 million in a Series A extension led by The Cigna Group Ventures. It adds to $16 million from the Series A raised in April 2022 by the startup, which provides virtual visits, prescriptions and lab tests related to conditions like hypertension, type 2 diabetes and weight management.”
    • “Cigna’s investment comes as health plans and pharmacy benefit managers (the PBM Express Scripts is a subsidiary of Cigna) are grappling with how to cover the high cost of GLP-1 medications for conditions like type 2 diabetes and weight loss. It’s among the first investments from an insurance company’s venture arm into a startup prescribing the drugs, which have turned into huge blockbusters and prompted broad conversations about their cost — and benefit — to the healthcare system.”
  • The Wall Street Journal reports,
    • “Pharmaceutical companies are spending billions of dollars to develop drugs that can target cancer like guided missiles.
    • “Therapies known as antibody-drug conjugates, which help deliver chemotherapy directly to tumors, have gotten most of the attention and are farthest along: 
    • “Pfizer’s $43 billion acquisition of biotech Seagen Inc. last year underscored how hot the field has become. 
    • “More quietly, a concept known as radiopharmaceuticals is also gaining ground. In recent months, interest in this space has led to a rise in dealmaking. The idea is similar to ADCs in that a patient receives an old treatment—in this case, a radioactive particle instead of chemotherapy drugs—but it is bound with a molecule that can chase down tumor cells. The technology is at a more nascent stage, but a steady growth of venture capital money and acquisitions by large pharmaceutical companies means this could well become a key part of the fight against cancer in the next decade or so.”
  • HR Dive discusses an EEOC lawsuit against a Georgia retirement community “for firing a 78-year-old receptionist after repeatedly asking her to retire. “The right to decide a retirement age lies with an employee, not their employer,” an EEOC official said.

Happy Presidents’ Day

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC

From the public health and medical research front,

  • ABC News reports,
    • “Half of all states are seeing high levels of respiratory virus activity, new federal data updated Friday shows.
    • “Currently, 25 states plus New York City and Washington, D.C., are experiencing “high” or “very high” levels of respiratory illness activity, according to the Centers for Disease Control and Prevention (CDC).
    • “While this is higher than the 23 states experiencing “high” or “very high” activity levels last week, it is fewer than the peak of 38 states reporting “high’ or ‘very high’ levels the week ending Dec. 30. * * *
    • “Adults over age 65 continue to have the highest rates of both COVID and flu hospitalizations.”
  • Fortune Well informs us,
    • “Vaccines that protect against severe illness, death and lingering long Covid symptoms from a coronavirus infection were linked to small increases in neurological, blood, and heart-related conditions in the largest global vaccine safety study to date.
    • “The rare events — identified early in the pandemic — included a higher risk of heart-related inflammation from mRNA shots made by Pfizer Inc., BioNTechSE, and Moderna Inc., and an increased risk of a type of blood clot in the brain after immunization with viral-vector vaccines such as the one developed by the University of Oxford and made by AstraZeneca Plc. 
    • “The viral-vector jabs were also tied to an increased risk of Guillain-Barre syndrome, a neurological disorder in which the immune system mistakenly attacks the peripheral nervous system.”
  • and
    • “They say anything men can do, women can do better—which may include reaping the health benefits of regular exercise. That’s according to a new study published today in the Journal of the American College of Cardiology.
    • “An international team of researchers from the U.S. and China showed that women who exercise regularly have a significantly lower risk of an early death or a fatal cardiovascular event than men who do the same. On top of that, the advantage holds true even when women put in less effort.
    • “The observational study, which analyzed the exercise habits of more than 400,000 U.S. adults, found that compared to being inactive, engaging in regular physical activity lowered women’s mortality risk by 24%. Men saw a 15% reduction in risk.
    • “Women who worked out also had a 36% reduced risk of a fatal cardiovascular event, such as a stroke or heart attack, than their inactive peers. Among men, those who were physically active showed a 14% reduced risk.”
  • The Washington Post reports,
    • “About 1 in 4 U.S. adults 65 and older — more than 14 million people — suffer a fall each year, according to the Centers for Disease Control and Prevention.
    • “Falls are the leading cause of injury among those 65 and older, even though not all falls result in an injury, the CDC says. About 37 percent of older people who have fallen have sustained an injury that required medical treatment or activity restrictions. For instance, the CDC reports that 95 percent of hip fractures result from a fall, and falls also are the most common cause of traumatic brain injuries.
    • “The National Institute on Aging notes that the odds of falling increase with age, but falls often can be prevented. Standard suggestions include fall-proofing your home space (making sure all stairs have hand rails and are well-lit, eliminating most throw rugs and keeping walk spaces clutter-free), careful management of medications (especially those that can cause dizziness or confusion), having regular vision checks and staying as active as possible (including doing exercises to maintain strength and balance).”
  • STAT News tells us,
    • “Niacin, or vitamin B3, has long been a U.S. public health darling to the point that it is added, by law, to cereal products. But a new study published Monday in Nature Medicine points to a potentially concerning effect of an excess of the vitamin: It may increase the risk of cardiovascular disease.
    • “The study looked into two cohorts of patients without active heart disease, 60% of whom were treated with statins, and found a strong association between a metabolic product of excess niacin and an increased risk of major adverse cardiovascular events such as a heart attack or stroke. One in four of the people in the study had excess niacin, which doubled their risk of major cardiovascular events to levels comparable with diabetes or a previous heart attack.
    • “It’s a fairly sizable risk. It’s on par with what we consider other large risks,” said Stanley Hazen, the section head of preventive cardiology and cardiac rehabilitation at the Cleveland Clinic and senior author of the study. “This opens up the door; it lays the foundation for new studies and new interventions from both a diagnostic and therapeutic perspective to try to reduce inflammation and cardiovascular disease.”
  • Per Medscape,
    • “A plant-based diet, low in dairy and meat but rich in fruits, vegetables, grains, and nuts, can improve sexual and urinary health in patients treated for local prostate cancer, new research showed.
    • “The findings, published on February 13, 2024, in the journal Cancer, bolster previous research showing plant-based diets can reduce the risk for recurrence and improve survivorship in men with prostate cancer.
    • “The current study shows for the first time an association between eating more plant-based food with better scores for quality of life among patients diagnosed with prostate cancer,” Stacy Loeb, MD, a urologist in the Departments of Urology and Population Health at NYU Langone Health, in New York City, who led the research.”
  • and
    • Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

From the healthcare business front,

  • The Wall Street Journal reports,
    • “China has more obese people than anywhere else in the world, and they are increasingly turning to weight-loss drugs to solve the problem.
    • “That is fueling a gray market of drug sellers and buyers, who have little trouble getting around China’s rules on the use of Ozempic. 
    • “Ozempic isn’t available for weight loss in the country, instead being reserved for the treatment of Type 2 diabetes. But users on e-commerce platforms are able to buy the shots, colloquially known as “miracle drugs,” simply by declaring they have been diagnosed with diabetes—without providing proof. 
    • “They aren’t getting a bad deal: On JD.com, a dosage of Ozempic retails for around $139. That is higher than its cost on the country’s national-insurance plan but much cheaper than the $970 some users pay in the U.S. each month. JD.com didn’t respond to requests for comment.”
  • NPR Shots notes,
    • “Bayer is the latest name-brand drugmaker to dip its toe into the world of Mark Cuban’s online pharmacy, Cost Plus Drugs. 
    • “The website offers drugs at steep discounts bypassing middlemen called pharmacy benefit managers. It mostly sells generics, but has been slowly adding brand name products as well. 
    • “Yaz birth control pills and Climara, a hormone patch for menopause, will both now be available for a fraction of their list prices, including Cost Plus’s standard 15% markup and shipping.
    • “As I look at our partnership with Cost Plus, I really look at this as a test and learn,” says Sebastian Guth, president of U.S. Pharmaceuticals at Bayer. “It’s a first initial step. We will learn and see what the results of this partnership are and may then decide to expand it further.”
  • Beckers Payer Issues points out,
    • “Some health systems are getting out of the insurance business. 
    • “In the first weeks of 2024, two health systems announced plans to sell their health insurance subsidiaries. In February, Springfield, Mass.-based Baystate Health reached a deal to sell Health New England to Point32Health. 
    • “In January, Toledo, Ohio-based ProMedica said it planned to sell its insurance subsidiary, Paramount Health, to Medical Mutual of Ohio. 
    • “Baystate Health has around 180,000 members in Medicare, Medicaid and commercial, and Paramount Health has more than 77,000 members in Medicare Advantage, commercial, individual and short-term plans. Both are set to be acquired by larger nonprofit insurers. Point32Health and Medical Mutual of Ohio each have over 1 million members.” 

Midweek Update

David Ermer–Congress, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The American Hospital Association News reports,
    • “The House Energy and Commerce Subcommittee on Health Feb. 14 held a hearing on AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.  
    • “Among other measures, the hearing highlighted legislation (H.R. 6960) to reauthorize the Emergency Medical Services for Children Program, which provides funding for equipment and training to help hospitals and paramedics treat pediatric emergencies. AHA advocated for funding the program at $28 million for fiscal year 2024.”
  • According to HHS press releases,
    • “On Wednesday, February 14, 2024, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra and leaders from across HHS met with state leaders and representatives from the National Governors Association (NGA) to announce the launch of HHS Secretary’s Postpartum Maternal Health Collaborative. The six states that have agreed to participate in the Postpartum Maternal Health Collaborative are Iowa, Massachusetts, Maryland, Michigan, Minnesota, and New Mexico.
    • “This new collaborative seeks to bring together state experts, local providers, community partners, and federal experts to develop a better understanding of the challenges being experienced among the postpartum population and support new solutions that will improve postpartum mortality. In conjunction with this new HHS collaborative, the National Governors Association launched their Improving Maternal and Child Health in Rural America State and Territory Policy Learning Collaborative. This new initiative will focus on implementing policy changes to improve maternal and child health outcomes in rural America.”
  • and
  • and
  • Meritalk adds,
    • “The Office of Personnel Management (OPM) today released its 2023 Equity Action Plan, which spotlights data as a tool to better understand barriers and advance diversity, equity, inclusion, and accessibility (DEIA) in the Federal workforce.
    • “OPM plans to advance the equitable participation of Federal employees in the Federal Employees Health Benefits (FEHB) Program by conduct a mixed methods study that will access and analyze data to identify barriers and potential solutions to accessing health benefits.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved a new regimen for pancreatic cancer, clearing Ipsen’s Onivyde to be used with chemotherapy in treating recently diagnosed metastatic tumors, the company announced Tuesday.
    • “Onivyde, which Ipsen bought from Merrimack Pharmaceuticals seven years ago, has been available for second-line use in pancreatic cancer, after tumor progression. The new OK will give physicians the option to use it earlier.
    • “The FDA’s decision was based on results from a Phase 3 trial Ipsen ran involving 770 people with metastatic pancreatic cancer. The data showed that Onivyde plus the chemo regimen FOLFOX improved survival and delayed tumor progression for longer than a combination of the drugs Abraxane and gemcitabine.”
  • Beckers Hospital Review informs us,
    • “On Feb. 14, the FDA approved Aurlumyn, the nation’s first treatment for severe frostbite. 
    • “Severe frostbite, which is estimated to affect 1% of the general population, happens when the skin and underlying tissue are frozen and blood flow is stopped. Aurlumyn (iloprost) is an injection that works by opening blood vessels, preventing blood from clotting.
    • “The skin damage from severe frostbite sometimes requires finger and toe amputations. In a trial of 47 patients, a bone scan after one week predicted that zero of the 16 study participants who received iloprost alone would need an amputation, compared to 3 of the 16 who received the drug with another experimental frostbite therapy and 9 of 15 who received another unapproved therapy alone. 
    • “Actelion Pharmaceuticals US received the drug approval.” 
  • STAT News tells us,
    • “An advisory panel to the Food and Drug Administration voted in favor of a new device from Abbott meant to treat patients with tricuspid heart valve disease. All but one of the 14 panelists said the treatment’s benefits outweighed its risks. The FDA tends to follow advisory panel recommendations.
    • “If we can help symptoms with this at a low cost in terms of risk, I think it makes a lot of sense,” said James Blankenship, a panelist and cardiologist at the University of New Mexico. 
    • “The device is called the TriClip, and it addresses a disease called tricuspid regurgitation: a heart condition that causes blood to leak backward through the tricuspid heart valve. The condition impacts 1.6 million people in the United States. Symptoms include fatigue, swelling, and atypical heart rhythms. In severe cases, the condition can lead to heart failure. 
    • “Current treatment options are drugs to reduce extra fluids or correct heart rhythm, or in more serious cases, surgery to correct the valve. Abbott hopes to cater to patients for whom medications are ineffective and surgery is too risky. The device, which clips together the disparate parts of the valve, is delivered via a catheter rather than open heart surgery.” 
  • Per an HHS press release,
    • “Today the Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services (HHS) jointly issued a Request for Information to understand how the practices of two types of pharmaceutical drug middlemen groups—group purchasing organizations (GPOs) and drug wholesalers—may be contributing to generic drug shortages.
    • “In the Request for Information (RFI) – PDF, the FTC and HHS are seeking public comment regarding market concentration among large health care GPOs and drug wholesalers, as well as information detailing their contracting practices. The joint RFI seeks to understand how both GPOs and drug wholesalers impact the overall generic pharmaceutical market, including how both entities may influence the pricing and availability of pharmaceutical drugs. The joint RFI is asking these questions to help uncover the root causes and potential solutions to drug shortages.”
  • Per Govexec,
    • “Last December, lawmakers included a new provision in the 2024 National Defense Authorization Act clarifying that “honorable” active duty military service will count toward the FMLA’s eligibility requirements, and in turn to the federal workforce’s paid parental leave benefit.
    • “In a memo to agency heads Tuesday, OPM Director Kiran Ahuja outlined how federal agencies should implement the tweak. Specifically, federal employees whose military service would put them over a year of federal service should “immediately” become eligible for the two forms of leave, dating back to Dec. 22, 2023, the day President Biden signed the NDAA into law.”

From the public health and medical research front,

  • The National Institutes of Health explains,
    • “Women who receive an mRNA-based COVID-19 vaccination or booster during pregnancy can provide their infants with strong protection against symptomatic COVID-19 infection for at least six months after birth, according to a study from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. These findings, published in Pediatrics(link is external), reinforce the importance of receiving both a COVID-19 vaccine and booster during pregnancy to ensure that infants are born with robust protection that lasts until they are old enough to be vaccinated.
    • “COVID-19 is especially dangerous for newborns and young infants, and even healthy infants are vulnerable to COVID-19 and are at risk for severe disease. No COVID-19 vaccines currently are available for infants under six months old. Earlier results from the Multisite Observational Maternal and Infant COVID-19 Vaccine (MOMIv-Vax) study revealed that when pregnant volunteers received both doses of an mRNA COVID-19 vaccine, antibodies induced by the vaccine could be found in their newborns’ cord blood. This suggested that the infants likely had some protection against COVID-19 when they were still too young to receive a vaccine. However, researchers at the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC), which conducted the study, did not know how long these antibody levels would last or how well the infants would actually be protected. The research team hoped to gather this information by following the infants through their first six months of life.”
  • STAT News lets us know,
    • “Public health messages have told us for decades that if you smoke, you should quit. And if you don’t smoke, don’t start. But a new study suggests smoking may be even worse than we thought.
    • “The study, published Wednesday in Nature, underscores the importance of never lighting up that first cigarette, based on its conclusion that smoking has much longer harmful effects on immune responses than previously understood.
    • “People who quit smoking soon regained normal function of their immune system’s power to mount fast and general innate responses to bacteria or viruses. But researchers also found that slower, more targeted adaptive T cell defenses remembered from past pathogens did not come back so soon after that last cigarette.
    • “We could see that the effect of active smoking on inflammatory responses to bacterial stimulation were lost when individuals quit smoking,” senior study author Darragh Duffy of the Institut Pasteur said about the innate response on a call with reporters. “In contrast, the effect on the T cell response was maintained for many years after the individuals quit smoking.”
  • STAT News further reports
    • “The HPV vaccine is a success story in some countries, including the U.K., where it beat estimates of how long it would take to nearly eliminate cervical cancer, the disease it is designed to prevent, among young women. And that was more than two years ago. Last month, a study in Scotland found no cases of cervical cancer in women who were vaccinated before age 14. In the U.S., it’s still a work in progress. A CDC report out today tells us that 39% of children age 9 to 17 had received at least one dose of the HPV vaccine, with rates rising with age from 7% in the youngest kids  to 57% in the oldest. Some differences in who got vaccinated:
      • “By insurance: Private health insurance (42%), Medicaid (37%), other government coverage (30%), and no insurance (21%).
      • “By neighborhood: Large central metropolitan areas (4o%), large fringe metropolitan areas (41%), and medium and small metropolitan areas (39%), and nonmetropolitan areas (30%).” 

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Elevance Health’s $2.5 billion acquisition of Blue Cross and Blue Shield of Louisiana is on pause yet again amid concerns about the impact on competition.
    • “BCBSLA posted a statement on its website Wednesday, saying that while the insurer wants to find a “strong partner” that can support it into the future, the team has also heard the skepticism in the Pelican State.
    • “We continue to hear from our stakeholders that they want Blue Cross and Blue Shield of Louisiana to remain their trusted partner in their healthcare journey, and we pursued this transaction to help us do exactly that — by changing for the better,” the insurer said. “However, it is clear that our stakeholders need more time and information to understand the benefits of the changes we have proposed.”
    • “This is why we have decided to again pause the process in our proposed transaction with Elevance Health,” BCBSLA said.”
  • BioPharma Dive notes,
    • “Sage Therapeutics said its new medicine, the first oral treatment for postpartum depression, is off to an encouraging start, with signs of demand from prescribing doctors.
    • “Sage and partner Biogen began selling the drug, Zurzuvae, in mid-December and on Wednesday Sage shared the first data from an estimated 10 days when doctors’ offices were open at the end of the month. During that time, physicians wrote about 120 prescriptions for the drug and 50 prescriptions were shipped and delivered to patients.”