Happy Pi Day!

Happy Pi Day!

Photo by Taso Katsionis on Unsplash

From Washington, DC

  • The bipartisan leadership of the Senate Finance Committee are pressing Congress for prescription benefit manager reform.
    • Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo R-Idaho, today renewed their call for the passage of their bipartisan legislation to crack down on pharmacy benefit managers (PBMs) and their shadowy tactics that are driving up the cost of prescription drugs and forcing pharmacies across the country to close their doors.
    • Ahead of a press conference this morning where Senators Wyden and Crapo were joined by pharmacy and patient advocates to press for PBM reform, the Senators sent a letter to their Finance Committee colleagues reaffirming their commitment to getting their legislation across the finish line as soon as possible this Congress.
  • FEHBlog observation — Read this Brookings Institution article to understand why the Senator’s position may be overwrought.
  • STAT News reports,
    • “Novo Nordisk’s newly won permission to market the heart benefits of its obesity drug Wegovy could provide a backdoor way to expand access to the drug for people on Medicare, experts told STAT.
    • “Currently, Medicare is prohibited by law from covering medications for obesity treatment alone. While companies that manufacture wildly popular anti-obesity medications and their allies haven’t been successful in lobbying Congress to change the law, the Food and Drug Administration’s move could give doctors an avenue to prescribe the medications to some Medicare patients.
    • “Wegovy’s new label indicates that the drug can be used to reduce the risk of major heart complications for people who are overweight or obese and have existing heart disease, Novo said in a statement Friday.
    • “This is definitely… an opportunity for patients with both cardiovascular disease and obesity to potentially get this drug when they couldn’t get it just for obesity alone,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF.”
  • MedPage Today tells us,
    • “The FDA granted accelerated approval to resmetirom (Rezdiffra) as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH), also now referred to as metabolic dysfunction-associated steatohepatitis (MASH).
    • “A once-daily oral agent, resmetirom is a liver-directed thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH; the drug is specifically indicated for NASH patients with moderate to advanced liver fibrosis, consistent with stages F2 to F3 fibrosis, and should be used along with diet and exercise, according to the agency.
    • “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, MD, of FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
    • “A result of non-alcoholic fatty liver disease (NAFLD) progression, NASH can lead to liver fibrosis and dysfunction, raising the risk of transplant and hepatocellular carcinoma. The condition is often associated with hypertension and diabetes.
    • “According to some estimates, 6 million or more Americans have NASH with stages F2 to F3 fibrosis, a number only expected to increase in the coming years.”
  • Healthcare IT News fills us in on an interesting conversation between the Deputy Coordinator of Health Information Technology and the CDC Director at the HIMSS conference in Orlando.

From the public health and medical research front,

  • The New York Times reports,
    • “Teen pregnancy increases the chances that a young woman will drop out of school and struggle with poverty, research has shown. Teenagers are also more likely to develop serious medical complications during pregnancy.
    • “Now a large study in Canada reports another disturbing finding: Women who were pregnant as teenagers are more likely to diebefore their 31st birthday. The trend was observed among women who had carried teen pregnancies to term, as well as among those who had miscarried.
    • “The younger the person was when they became pregnant, the greater their risk was of premature death,” said Dr. Joel G. Ray, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto and the first author of the study. It was published in JAMA Network Open on Thursday.
    • “Some people will argue that we shouldn’t be judgmental about this, but I think we’ve always known intuitively that there’s an age that is too young for pregnancy,” he added.
  • The Washington Posts informs us,
    • “A new study calls into question the extent of the maternal mortality crisis in the United States, which has long posted a disproportionately high rate of maternal deaths compared with peer nations.
    • “Data classification errors have inflated U.S. maternal death rates for two decades, according to the study published Wednesday in the American Journal of Obstetrics & Gynecology. Instead of the maternal death rate more than doubling since 2002, it has remained flat, researchers found.
    • “There has been a lot of alarm and apprehension surrounding the fact that some of these reports show a threefold increase in maternal mortality, and that is not what we found. We found low and stable rates,” said K.S. Joseph, the study’s lead author and professor in the departments of obstetrics and gynecology and the School of Population and Public Health at the University of British Columbia in Vancouver. * * *
    • “Some experts say the study’s biggest takeaway is the persistent racial disparities, with many pregnant Black people experiencing more medical complications involving Caesarean sections, postpartum hemorrhaging and preterm births. However the data is calculated, the pattern remains the same, said Colleen Denny, an associate professor in the department of obstetrics and gynecology and director of family planning at NYU Langone Hospital as well as a fellow of the American College of Obstetricians and Gynecologists.
    • “We should be targeting a lot of our public outreach to focus on conditions that are affecting patients of color while they’re pregnant,” said Denny, who was not involved with the study.”

From the cybersecurity front,

  • UHC updated its Change Healthcare cyberattack response website today.
    • “Palo Alto Networks Unit 42 experts are on the ground, collaborating diligently with UnitedHealth and their partners to restore operations and ensure a swift and secure resolution following the recent disruption. To date we have reviewed and protected a large majority of infrastructure, including the server and application space, and assisted in bringing critical services back online that allowed for more than 9 million prescriptions to be filled.” 
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services March 13 released additional information on the Medicare accelerated and advance payments that hospitals, physicians and others impacted by the Change Healthcare cyberattack may apply for through their Medicare Administrative Contractors. According to CMS, the MACs aim to review requests and notify most providers/suppliers of the outcome of their request within five business days of receipt.
  • Aetna provides a good example of the information that other carriers are sharing with their network providers and members about the Change Healthcare situation.

From the U.S. healthcare business front,

  • EBRI offers new research about health savings accounts.
    • HSA balances continued to increase over the course of the year, despite higher spending on health care. Continuing a trend observed post-COVID-19 pandemic, patient spending on health care increased in 2022. Still, average end-of-year HSA balances were higher than average beginning-of-year balances. Average balances increased at an even faster rate in 2022, conditional on those accounts receiving either an employee or employer contribution over the course of the year. 
    • Accounts that received an employer contribution saw higher total contributions and were more likely to invest. Employers seeking to help their workers engage with their HSAs may find employer contributions to be a useful tool, as accountholders who received an employer contribution on their behalf had higher average total contributions and were more likely to invest. Our analysis indicates, however, that these accountholders were also more likely to take more frequent and larger distributions. 
    • Most accountholders took a distribution in 2022. More than half of the HSAs in EBRI’s database saw a distribution in 2022, and the average distribution was $1,868. 
    • Relatively few HSAs are invested. One of the largest advantages HSAs offer is the ability to invest assets within the account. However, our analysis reveals that only 13% of accountholders invested their HSAs in assets other than cash. 
    • Age and tenure play a major role in HSA utilization. Consistent with previous findings, accountholder age — as well as accountholder tenure — is closely related to average balances, contributions, and distributions, as well as the propensity to invest. On average, older accountholders contributed more to their HSAs, had higher balances, more frequently took distributions, and had a higher likelihood of investing at least some portion of their HSA in assets other than cash.”
  • McKinsey and Co. shares its report on the future of Medicare Advantage.
    • “The Medicare Advantage program is undergoing its biggest shifts in more than two decades. Payers can take steps now to mount a strategic, agile response as the changes unfold.”

 

Happy International Women’s Day

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

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 discussesNewsweek‘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. 

Midweek update

Photo by Manasvita S on Unsplash
  • Roll Call informs us,
    • “Congressional leaders reached an agreement on final fiscal 2024 appropriations bills Wednesday that will pave the way for lawmakers to wrap up the process in two packages in the coming days and weeks, sources familiar with the deal said.
    • “Funding for agencies covered by the Agriculture, Energy-Water, Military Construction-VA and Transportation-HUD bills would be extended from March 1 through March 8, joining the Interior-Enviroment and Commerce-Justice-Science bills in the first tranche. Lawmakers are expected to release text of the stopgap spending measure as soon as Wednesday.
    • “Appropriators are aiming for text for the first tranche by Sunday in order for the House to be able to turn around and vote Wednesday, before Thursday gets swallowed up by President Joe Biden’s State of the Union address. In theory, that would give the Senate time to get the first package to Biden’s desk before the impacts of a partial shutdown on those agencies subject to the new March 8 deadline are felt.
    • “Stopgap funding for the remaining six bills, which had been set to lapse March 9, would last through March 22, giving lawmakers enough time to finish turning the deal into legislative text and getting them through both chambers. That package will consist of the Defense, Labor-HHS-Education, Homeland Security, Financial Services, State-Foreign Operations and Legislative Branch measures.” (FEHBlog note — FEHB appropriations are included in the Financial Services bill.]
  • and
    • “Mitch McConnell’s announcement [today] that he will voluntarily end his record-setting reign as Senate Republican leader drew praise and some derision Wednesday, as a contest to succeed him that was already underway began to move out from behind the scenes.
    • “Potential candidates to replace McConnell include the “three Johns,” as they’re known, who have all served as deputies under McConnell in recent years. South Dakota Sen. John Thune, currently the No. 2 Senate Republican; Wyoming Sen. John Barrasso, the current conference chair; and Texas Sen. John Cornyn, a former GOP whip who termed out of leadership, could all make a run for party leader.” 
  • The Bipartisan Policy Center adds,
    • “An additional factor affecting FY2024, which runs from October 1, 2023, through September 30, 2024, and FY2025 is the Fiscal Responsibility Act or FRA—the bipartisan debt limit deal that set discretionary spending levels for two years. The FRA includes a provision that reduces spending caps in the deal and enforces a sequester (an across-the-board cut) if one or more agencies are covered by a CR after April 30, 2024. There is some uncertainty over whether a full-year CR would trigger this April 30 provision. The executive branch’s Office of Management and Budget (OMB) is ultimately responsible for making that decision.”
  • STAT News reports,
    • “In a bid to combat prescription drug costs, the White House will hold a listening session on Monday in search of ways to reform pharmacy benefit managers, according to people familiar with the plans.
    • “The list of attendees includes representatives from the federal government and industry, who are expected to provide insights into how the largest pharmacy benefit managers determine which medicines are covered by insurers and employers, as well as prices that are paid at pharmacy counters. Critics say these middlemen rely on an opaque process that drives up costs for patients and taxpayers.
    • “Among those invited is Mark Cuban, whose Cost Plus Drug Company is trying to transform the marketplace by avoiding the largest middlemen when reaching benefits agreements with employers. He will “just convey what our experience has been at Cost Plus and, if they ask, [make] suggestions on what we think can make things better,” he told us when asked about his expectations for the meeting.”

From the public health and medical research front,

  • The American Hospital Association News tells us,
    • “Centers for Disease Control and Prevention Director Mandy Cohen, M.D., Feb. 28 endorsed a recommendation by its Advisory Committee on Immunization Practices that adults ages 65 years and older receive an additional updated 2023-2024 COVID-19 vaccine dose. 
    • “Today’s recommendation allows older adults to receive an additional dose of this season’s COVID-19 vaccine to provide added protection,” Cohen said. “Most COVID-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk.”
    • “CDC continues to recommend that everyone stay up to date on their COVID-19 vaccines, especially people with weakened immune systems.”
  • The Wall Street Journal adds,
    • “The CDC’s final decision ensures most health plans cover the inoculations without an out-of-pocket charge when furnished in-network].
    • “Most Covid-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk,” CDC Director Dr. Mandy Cohen said.”
  • The National Institutes of Health announced,
    • “Frequent cannabis smoking may significantly increase a person’s risk for heart attack and stroke, according to an observational study supported by the National Institutes of Health. The study, published in the Journal of the American Heart Association, uses data from nearly 435,000 American adults, and is among the largest ever to explore the relationship between cannabis and cardiovascular events.   
    • “The study, funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, found that daily use of cannabis — predominately through smoking — was associated with a 25% increased likelihood of heart attack and a 42% increased likelihood of stroke when compared to non-use of the drug. Less frequent use was also associated with an increased risk of cardiovascular events. Weekly users showed a 3% increased likelihood of heart attack and a 5% increased likelihood of stroke.
    • “Around 75% of the study respondents reported that they mainly used cannabis by smoking the drug. Approximately 25% of the respondents reported using cannabis by some method other than smoking, such as vaping, drinking, or eating the drug.
    • “We know that toxins are released when cannabis is burned, similar to those found in tobacco smoke,” said corresponding author Abra Jeffers, Ph.D., a data analyst at Massachusetts General Hospital in Boston and formerly a researcher at the Center for Tobacco Control Research and Education at the University of California, San Francisco, where she conducted the study as part of her postdoctoral work.
    • “We’ve known for a long time that smoking tobacco is linked to heart disease, and this study is evidence that smoking cannabis appears to also be a risk factor for cardiovascular disease, which is the leading cause of death in the United States,” Jeffers said. “Cannabis use could be an important, underappreciated source of heart disease.”
  • MedPage Today lets us know,
    • “Mortality from colorectal cancer (CRC) decreased significantly in patients who were offered early screening with fecal occult blood testing (FOBT), a large prospective cohort study showed.
    • “Cancer-specific mortality decreased significantly by 14% in patients who underwent early screening for CRC, as compared with a control group that received late or no invitations to participate in screening. Excess mortality decreased by 16% in the exposure group.
    • “The results probably underestimated the true impact of screening with FOBT, as some participants in the control group underwent testing, reported Johannes Blom, MD, PhD, of the Karolinska Institutet in Stockholm, and co-authors in JAMA Network Openopens in a new tab or windowClinicians and patients now have greater confidence that CRC screening reduces the risk of dying of CRC.”
  • The Society for Human Resource Management offers ten tips to Support Mental Health in Multigenerational Workplaces.”
  • MedTech Dive informs us,
    • “Johnson & Johnson has started patient enrollment in a pivotal trial to evaluate its Laminar left atrial appendage (LAA) elimination device for reducing stroke risk due to blood clot formation in the heart, the company said Tuesday.
    • “The investigational device exemption study will enroll 1,500 patients with atrial fibrillation (AFib), a common form of irregular heart rhythm, at up to 100 U.S. sites.
    • “J&J, which acquired privately held Laminar for $400 million in November, is among the medtech companies aiming to challenge Boston Scientific, whose Watchman implant leads the fast-growing market for LAA devices.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review lists the 43 U.S. hospitals listed in Newsweeks top 250 hospital worldwide. U.S. hospital form four of the top five.
    • 1. Mayo Clinic-Rochester (Minn.)
    • 2. Cleveland Clinic
    • 4. The Johns Hopkins Hospital (Baltimore)
    • 5. Massachusetts General Hospital (Boston)
  • Per Healthcare Dive,
    • “Universal Health Services is guiding to a stronger 2024 than analysts had expected after beating Wall Street’s revenue expectations in fourth-quarter results released Tuesday.
    • “The massive for-profit hospital operator expects to bring in revenue between $15.4 billion and $15.7 billion this year, which represents almost 9% year-over-year growth at the midpoint. In comparison, UHS grew revenue almost 7% last year, ending 2023 with $14.3 billion. The system’s profit was $717.8 million, up 6%.
    • “UHS was helped in the fourth quarter from better-than-expected behavioral health volumes, despite continued cost pressures from physician subsidy expenses and the ongoing Medicaid redetermination process.”
  • Per Fierce Healthcare,
    • “Danbury, Connecticut-based Nuvance Health is joining Northwell Health, New York’s largest provider and private employer, under a strategic merger agreement unveiled Wednesday.
    • “The deal, which still requires regulatory signoffs, would create a healthcare network of more than 28 hospitals, over 1,000 care sites, nearly 100,000 staff and 14,500 employed providers, the two nonprofits said in their joint announcement.
    • “This partnership opens a new and exciting chapter for Northwell and Nuvance and provides an incredible opportunity to enhance both health systems and take patient care and services to an even higher level,” Michael Dowling, president and CEO of Northwell Health said in the announcement. “We have similar missions in providing high-quality care for patients in the communities we serve. We look forward to building on the care that Nuvance Health’s 14,000 staff members and providers deliver each and every day.”
  • Health Equity explains why employer matching contributions to employee health savings accounts can be game changer when trying to lower healthcare costs.
    • “When implementing an HSA contribution plan, it’s helpful to structure the program in a way that is not only cost-effective but also encourages adoption. Seed options are a good way to encourage HSA use because they directly help employees with healthcare costs. You can make seed contributions in several ways, such as:
      • A lump sum
      • Smaller amounts throughout the year
      • Or a combination of both tactics
    • “To boost adoption, consider offering an HSA-qualified plan with lower premiums than your regular plan. This way, the choices cost about the same. For instance, you could offer a PPO plan with a $400 monthly premium or an HSA-qualified plan with a $200 monthly premium and an extra $200 monthly employer seed.
    • “It’s not uncommon for organizations to seed the first year of an employee’s HSA to help them transition into the plan, but few make the important switch to a match system to continue encouraging contributions.
    • “According to HealthEquity research, only 12% of employers provide a contribution match compared to 68% who offer a seed.”

Thursday Miscellany

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.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • STAT News reports
    • “The Biden administration is making its opening offers to pharmaceutical companies in its brand-new Medicare drug price negotiation program on Thursday, administration officials said. And that’s about all they said.
    • “The offers will not be made public unless a manufacturer chooses to publicly disclose information about the talks, a senior administration official said. Companies have until March 2 to either accept the government’s offer or propose a counteroffer. The Biden administration will publish the final prices by Sept. 1 of this year after the negotiation process ends. 
    • “The negotiated prices won’t take effect until 2026. 
    • “The first 10 drugs up for negotiation are Bristol Myers Squibb’s blood thinner Eliquis, Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, Johnson & Johnson’s blood thinner Xarelto, Merck’s diabetes drug Januvia, AstraZeneca’s diabetes drug Farxiga, Novartis’ heart failure treatment Entresto, Amgen’s rheumatoid arthritis drug Enbrel, Johnson & Johnson and AbbVie’s blood cancer treatment Imbruvica, J&J’s anti-inflammatory medicine Stelara, and Novo Nordisk insulins that go by names including Fiasp and NovoLog.”
  • Here is a link to PhRMA’s views on the development.
    • “The bottom line: This process is a black box that allows a few government bureaucrats to make politicized decisions about the value of medicines and with no accountability to patients or the public.”
  • BioSpace adds,
    • “A federal court in Delaware heard arguments Wednesday in a key lawsuit challenging Medicare drug-negotiation provisions of the Inflation Reduction Act (IRA). Reportsfrom inside the courtroom suggested that the judge was skeptical of the arguments raised by plaintiff AstraZeneca, though experts told BioSpace this is just an early step in what could be a protracted series of legal battles.
    • “While no ruling on AstraZeneca’s motion for summary judgment is expected for about a month, court activity will heat up over the next few weeks, as a total of 10 cases from pharma companies and groups have challenged various aspects of the IRA’s Medicare drug-pricing provisions. Other plaintiffs include MerckNovartisJohnson & JohnsonBristol Myers SquibbBoehringer Ingelheim, Novo Nordisk and the lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA).

From the public health and medical research front,

  • MedPage reports,
    • “The updated 2023-2024 COVID-19 vaccine was approximately 54% effective against symptomatic SARS-CoV-2 infection in adults, and was also effective against the JN.1 variant, which became predominant in January, CDC researchers said.
    • “Overall, vaccine effectiveness against symptomatic COVID was 57% for people ages 18 to 49 years and 46% for people ages 50 and older, reported Ruth Link-Gelles, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.”
  • and
    • “Military personnel stationed at Camp Lejeune from 1975 to 1985 had at least a 20% higher risk for a number of cancers than those stationed elsewhere, federal health officials said Wednesdayin a long-awaited study about the North Carolina base’s contaminated drinking water.
    • “Federal health officials called the research one the largest ever done in the U.S. to assess cancer risk by comparing a group who live and worked in a polluted environment to a similar group that did not.”
  • American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 updated it Overdose Prevention and Response Toolkit, which includes basic information on overdose prevention and treatment as well as specific guidance and resources for health care providers and prescribers.”
  • The Institute for Clinical and Economic Review released
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of iptacopan (Novartis) and danicopan (Alexion Pharmaceuticals) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). While important health benefits for patients were shown in clinical trials for both agents, there is uncertainty about long-term efficacy and safety. ICER’s model for iptacopan, which is already FDA-approved, using a shared-savings approach (described in more detail below), suggests that the drug would need to be priced 70% lower than the current list price to meet commonly accepted thresholds. For danicopan, which is not yet FDA-approved, ICER’s model suggests the price would need to be between $12,300 and $13,100 per year to achieve common thresholds for cost-effectiveness.
    • “This Evidence Report will be reviewed at a virtual public meeting of the California Technology Assessment Forum (CTAF) on February 16, 2024.”
  • NPR discusses aging.
    • I used to flinch at the topic of aging. Is there anything we can do about the inevitable?
    • But recently I’ve been digging into a new wave of longevity research that is making it an exciting time to be an aging human — which is all of us.
    • It turns out, we all age at varying rates. Super-agers may have great genes, but research shows our habits and routines — everything from what we eat and how we move our bodies to who we spend our time with — matter a lot, when it comes to aging well.
    • Now, the next frontier is to target the basic biology of aging and come up with new interventions to slow it down.
    • Many scientists are optimistic that we’re on the cusp of breakthroughs. Not only to help us live longer, but — more importantly — to extend the number of years we live with good health.
    • This is the goal of researchers at the Human Longevity Lab at the Northwestern University Feinberg School of Medicine. They’re recruiting study participants so they can test what kinds of interventions may slow the rate of aging.
  • The reporter describes participating in this study.
  • HealthDay informs us,
    • “Adolescent substance use is associated with psychiatric symptoms, including suicidal thoughts, according to a research letter published online Jan. 29 in JAMA Pediatrics.
    • “Brenden Tervo-Clemmens, Ph.D., from the University of Minnesota in Minneapolis, and colleagues examined associations between commonly used substances and psychiatric symptoms among adolescents in two samples: students from 36 Massachusetts high schools who completed the 2022 to 2023 Substance Use and Risk Factor (SURF) Survey and analogous self-reported items from the 2021 Youth Risk Behavior Survey (YRBS). Data were included for 15,626 SURF participants and 17,232 YRBS participants.
    • “The researchers found significant, moderate dose-dependent associations for alcohol, cannabis, and nicotine use with worse psychiatric symptoms, including suicidal thoughts in SURF and YRBS, depressive or anxiety symptoms and inattention or hyperactivity in SURF, and general mental health in YRBS.” 
  • Memory Care Business notes,
    • “A new global effort is underway to accelerate the prevention, diagnosis and management of Alzheimer’s and other forms of dementia. 
    • “The effort, dubbed the Alzheimer’s Moonshot, was announced by StartUp Health in partnership with the Alzheimer’s Drug Discovery Foundation’s Diagnostics accelerator and Gates Ventures, the private office of entrepreneur Bill Gates. 
    • “The Alzheimer’s effort is among a new series of “moonshots” from StartUp Health. The efforts also have taken aim at other health challenges, such as Type 1 diabetes, with the goal of bringing together like-minded company founders and researchers in those spaces.”
  • The Washington Post reports,
    • “An international team led by scientists at Stanford University has discovered a probable explanation for a decades-old biological mystery: why vastly more women than men suffer from autoimmune diseases such as lupus and rheumatoid arthritis.
    • “Women account for about 80 percent of the people afflicted with autoimmune diseases, a collection of more than 100 ailments that burden a combined 50 million Americans, according to the nonprofit Autoimmune Association. In simple terms, these illnesses manipulate the body’s immune system to attack healthy tissue.
    • “In a paper published Thursday in the journal Cell, researchers present new evidence that a molecule called Xist — pronounced like the word “exist” and found only in women — is a major culprit in these diseases.
    • “Better understanding of this molecule could lead to new tests that catch autoimmune diseases sooner and, in the longer term, to new and more effective treatments, researchers said.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Tenet Healthcare has disclosed a pair of new and completed hospital transactions alongside projections that next week’s 2023 financial report “will be above the high end” of its guidance.”
  • and
    • “New Jersey providers Saint Peter’s Healthcare System and Atlantic Health System have taken the first step toward a merger they said would include “significant investments” in the Catholic system’s service area.”
  • and
    • “Hospitals and health systems closed out the year on a high note with margins up more than 15% from 2022, according to Kaufman Hall.”
    • “The firm’s latest sector-wide monthly report pointed to an increase in year-to-date operating margin index, from 1.9% through November to 2.3% at the end of the year. On a single-month basis, the operating margin index rose from 3.2% to 4.6% at the same cutoffs.
    • “These improved margins indicate that hospitals and health systems are taking the necessary steps to adapt to this new environment,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a release. “While finances are approaching historic levels, today’s care and business models look very different. Organizations have had to adjust how and where they’re delivering services to better meet patient preferences.”
  • Healthcare Dive lets us know,
    • “Healthcare executives prioritize data considerations when it comes to using generative artificial intelligence, which could prevent them from successfully integrating the hot button technology, according to a report by consultancy Deloitte. 
    • “While 82% of 60 respondents rated data availability, quality and reliability as a top consideration for implementing generative AI, only 45% cited mitigating biases or patient education on the technology and its risks as their greatest considerations when implementing the technology.
    • “Data is important, but the industry needs a “robust overarching framework” that focuses equally on governance, consumer needs and worker concerns, the report’s authors wrote.”
  • STAT News reports,
    • Merck reported earnings for the fourth-quarter and 2023. On 2024 guidance, Merck said it expects sales in the range of $62.7-$64.2 billion, or a 6% increase at the midpoint. Current Street consensus is $63.5 billion. Adjusted earnings are forecast to be between $8.44 and $8.59 per share.
    • More pharma earnings from Roche and Sanofi.
  • and
    • “Novavax, the company whose corporate missteps repeatedly sidelined an effective Covid-19 vaccine, is relying on demand for booster doses to remain solvent. And the latest update isn’t exactly encouraging.
    • “The company said yesterday that it would lay off another 12% of its staff, expanding on a cost-cutting plan disclosed last year. In the end, Novavax will have reduced its workforce by about 30% compared to 2023, part of an effort to reduce its expenses in the months to come.”
  • NewFront offers guidance on correcting mistaken health savings account distributions.


 

The FEHBlog is back!!

On Friday, the FEHBlog flew from Austin to Washington, DC, having left his briefcase at home. As a result he did not have his laptop or his FEHBlog log in information over the weekend. He is back in action today.

From Washington, DC,

  • The White House issued a fact sheet about new actions taken by the White House Task Force on Reproductive Healthcare Access which is marking the 51st Anniversary of Roe v. Wade. Of note to the FEHB Program, the Fact Sheet discusses
    • “Strengthen[ing] Contraception Access and Affordability for Women with Private Health Insurance. The Administration is committed to ensuring that women have access to contraception—an essential component of reproductive health care that has only become more important in the wake of the Supreme Court’s decision to overturn Roe v. Wade—and reducing barriers that women face in accessing contraception prescribed by their provider. The Departments of the Treasury, Labor, and Health and Human Services (HHS) are issuing new guidance [ACA FAQ 64] to clarify standards and support expanded coverage of a broader range of FDA-approved contraceptives at no cost under the Affordable Care Act. This action builds on the progress already made by the Affordable Care Act to expand access to affordable contraception for millions of women nationwide.
    • “In addition, the Office of Personnel Management will strengthen access to contraception for federal workers, retirees, and family members by issuing guidance to insurers participating in the Federal Employee Health Benefits Program that incorporates the Departments’ guidance. OPM will also newly require insurers that participate in the Federal Employee Health Benefits Program to take additional steps to educate enrollees about their contraception benefits.”
  • You may recall that OPM issued comprehensive guidance for carriers on contraceptive coverage in Carrier Letter No. 2022-17 back in the summer of 2022.
  • The FEHBlog was surprised that new ACA FAQ 64 does not announce a decision on whether group health plans are required to cover the new over-the-counter female contraceptive Opill which is not yet reached pharmacy shelves. The FEHBlog expects that the regulators will requires that group health plans cover Opill with no cost sharing when purchased at a network pharmacy.
  • In related news, the HHS and Centers for Medicare and Medicaid Services announced:
    • “launch[ing] a series of actions to educate the public about their rights to emergency medical care and to help support efforts of hospitals to meet their obligations under the Emergency Medical Treatment and Labor Act (EMTALA). As part of this comprehensive plan, the Department will:
      • “Publish new informational resources on CMS’s website to help individuals understand their rights under EMTALA and the process for submitting a complaint if they are denied emergency medical care;
      • “Partner with hospital and provider associations to disseminate training materials on providers’ obligations under EMTALA; 
      • “Convene hospital and provider associations to discuss best practices and challenges in ensuring compliance with EMTALA; and
      • “Establish a dedicated team of HHS experts who will increase the Department’s capacity to support hospitals in complying with federal requirements under EMTALA.”
  • In sum, HHS Secretary Xavier Becerra also sent a “letter to Medicare plans, health insurance issuers, and State Medicaid and CHIP programs about upholding their [contraceptive coverage] bligations under federal law.
    • Secretary Becerra wrote: ‘From day one, the Biden-Harris Administration has made clear that women should have access to the healthcare they need, including contraception and other family planning services. I’m writing to reaffirm that access to reproductive healthcare is a core priority of the U.S. Department of Health and Human Services.’”
  • American Hospital News tells us,
    • “A Department of Veterans Affairs policy that provides free emergency suicide prevention care has helped nearly 50,000 veterans and former service members in its first year, the VA announced last week. The policy allows the agency to provide, pay for or reimburse for eligible individuals’ emergency suicide care, transportation costs and follow-up care at any VA or non-VA facility for up to 30 days of inpatient care and 90 days of outpatient care.”
  • CMS issued its latest top ten Section 111 reporting issues for group health plans.
  • Fierce Healthcare informs us,
    • Truveta, the real-world data analysis company backed by dozens of health systems and other life sciences groups, won a multi-million-dollar contract from the Centers for Disease Control and Prevention (CDC) to assist with the agency’s research into maternal health, pediatric care and respiratory viruses, including COVID-19.
    • “The company will let the CDC tap into its collection of more than 100 million patients’ deidentified, normalized electronic health record data.
    • “The Bellevue, Washington-based collective receives the information from its 30 health system members, which include major providers like Providence, Trinity Health and Tenet Healthcare. Together, the members provide over 18% of the country’s daily clinical care.”

From the public health and medical research front,

  • U.S. New and World Report lets us know,
    • “Coronavirus hospital admissions last week decreased for the first time in more than two months, according to data from the Centers for Disease Control and Prevention. Though the number remains elevated, weekly hospitalizations fell by nearly 10% week over week.
    • “More than 32,800 new COVID-19 hospital admissions were reported over the week ending Jan. 13, and over 27,800 Americans on average each day were considered currently hospitalized due to the disease during the same time frame, according to CDC data.
    • “Despite test positivity (percentage of tests conducted that were positive), emergency department visits, and hospitalizations remaining elevated nationally, COVID-19 rates have stabilized, or in some instances decreased,” the CDC said in a post on Friday.”
  • The CDC’s Fluview from last Friday notes,
    • “Seasonal influenza activity remains elevated in most parts of the country.
    • “After several weeks of increases in key flu indicators through the end of 2023, two weeks of decreasing or stable trends nationally have been noted. CDC will continue to monitor for a second period of increased influenza activity that often occurs after the winter holidays.
    • “Outpatient respiratory illness has been above baseline nationally since November and is above baseline in all 10 HHS regions.
    • “The number of weekly flu hospital admissions has decreased slightly for two consecutive weeks.”
  • Medpage Today points out,
    • “Several recent measles outbreaks have public health officials concerned — and are drawing attention to rising childhood vaccine exemptions and renewing calls for increased measles awareness.
    • “Philadelphia’s health department confirmed nine casesof the illness as of Tuesday, which spread at local health facilities and a daycare. At least three of the infections were in unvaccinated children, according to ABC News.
    • “As of January 12, two counties in Washington state noted “3 lab-confirmed and 3 [epidemiologically]-linked measles cases have been identified among unvaccinated adults.” Delaware identified 20-30 people who were exposed to measles at the Nemours Children’s Hospital a few days earlier. * * *
    • “Katelyn Jetelina, MPH, PhD, epidemiologist and author of the “Your Local Epidemiologist” newsletter, calls the recent measles outbreaks a potential symptom of “collective amnesia” in a recent newsletter, writing, “As generations age, the memory of mid-20th-century diseases like measles fade. … Some don’t know why this disease is bad or if this vaccine is safe. This is understandable.”
  • The FEHBlog subscribes to the Your Local Epidemiologist on Substack and he finds it to be worth the money.
  • NBC News reports,
    • “After decades of good news in the fight against cervical cancer — marked by decades of steady declines in cases and deaths — a new report suggests that some women are being left behind. * * *
    • “Among women in their 30s and early 40s, incidence has been edging upward. Diagnosis of cervical cancer among women ages 30 to 44 rose almost 2% a year from 2012 to 2019.
    • “We need to make sure we are not forgetting about that generation that was a little too old for HPV vaccination,” said Jennifer Spencer, an assistant professor at the Dell Medical School at University of Texas-Austin who studies population health.
    • “Fortunately, the cancers found in 30- and 40-something women were mostly early, curable tumors, said Ahmedin Jemal, senior author of the new report and the cancer society’s senior vice president for surveillance and health equity science. About 13,800 American women are diagnosed with cervical cancer each year and 4,360 die from the disease.”

From the U.S. healthcare business front,

  • Cigna issued a report on the top healthcare trends of 2024.
  • Kaiser Health News calls our attention to the following Modern Healthcare story
    • “Blue Cross Blue Shield insurers have become the first carriers to cover multimillion-dollar new gene therapies for sickle cell disease, and other insurers and Medicaid agencies are moving to follow suit. Blue Cross’ Synergie Medication Collective has inked risk-sharing agreements with drugmaker BlueBird Bio to offer its $3.1 million Lyfgenia gene therapy treatment for sickle cell disease to some self-insured employers, as well as competitor Vertex Pharmaceuticals’ $2.2 million Casgevy treatment.”
  • Per Fierce Healthcare,
    • “UnitedHealthcare is rolling out a new resource hub that seeks to make it easier for members to use wellness offerings while also easing the financial burden on employers.
    • “The UHC Hub features more than 20 different options, including wellbeing programs that target healthy living and more complex care management. Its network is built to make it easier for employers to find and purchase solutions and to make it simpler for consumers to engage.
    • “It’s not a secret that employers are feeling increasingly overwhelmed with the wide array of vendor options available to them. Samantha Baker, chief consumer officer for UnitedHealthcare’s commercial business, told Fierce Healthcare in an email that this is a pain point that comes up frequently in conversations with plan sponsors. * * *
    • “UnitedHealthcare said in an announcement that the hub builds on existing advocacy programs that it offers to clients, which help members in finding in-network providers, during a hospital discharge or in reviewing treatment and medication options.” 
  • Per Healthcare Dive,
    • “Intermountain-owned Saltzer Health said it will shut down if it cannot find a buyer by March 29, citing financial and economic challenges.
    • “The physician group said it’s in active negotiations with healthcare companies over the sale of some operations, and is “optimistic that a sale can be achieved,” according to a Thursday news release. 
    • “The health group, which is owned by Salt Lake City-based Intermountain Health, employs 450 people and serves approximately 100,000 annual patients across 11 Treasure Valley locations, according to a company spokesperson.”
  • BioPharma Dive explains why “With two biotech buyouts, schizophrenia drugs appear back on pharma’s radar. Deal documents suggest others besides Bristol Myers and AbbVie may be looking.”

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types, including previously initiated batched disputes, new batched disputes, and new single disputes involving air ambulance services. The departments also have extended the applicable deadlines to initiate new batched disputes and new single disputes involving air ambulance services, resubmit disputes determined by certified IDR entities to be improperly batched, and select or reselect a certified IDR entity. For details, see the [lengthy] announcement
  • In Department of Health and Human Services news,
  • and
    • “A paper published today in JAMA Network Open addresses the use of healthcare algorithms and provides the healthcare community with guiding principles to avoid repeating errors that have tainted the use of algorithms in other sectors. * * *
    • “The paper, Guiding Principles to Address the Impact of Algorithm Bias on Racial and Ethnic Disparities in Health and Health Care, may be found in JAMA Network Open is available here. The journal also links to an accompanying podcast interview of panel co-chairs Marshall Chin, MD, MPH, and Lucila Ohno-Machado, MD, PhD, MBA. The final EPC report, Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare, can be found here.”

In Food and Drug Administration news,

  • From Bio-Pharma Dive,
    • “The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a $1 billion buyout four years ago, clearing Welireg for use in people whose kidney tumors have progressed following treatment with two other types of medicines. 
    • “Approval was based on a trial that compared Welireg to an older therapy called everolimus. Merck’s drug reduced the risk of cancer progression or death by 25% compared with everolimus and shrank or eliminated tumors in 22% of people who received it. Welireg hasn’t yet proven it can help kidney cancer patients live longer, however. 
    • “Merck inherited Welireg when it bought biotechnology company Peloton Therapeutics. Since then, the drug’s been cleared for use in a rare condition called von Hippel-Lindau disease and now kidney cancer. Merck is studying its potential in other settings as well.”
  • From MedTech Dive,
    • “Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye.
    • “The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes.
    • “Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000.”
  • and
    • “Medtronic has gained the first approval from the Food and Drug Administration for a pulsed field ablation (PFA) system to treat atrial fibrillation (AFib), pulling ahead of other medtech companies in the race to bring the technology to the U.S. market.
    • “The treatment approach has garnered attention as a safer alternative to radiofrequency and cryoablation techniques for addressing the abnormal heart rhythm, and Boston Scientific and Johnson & Johnson are pursuing the market.
    • “Medtronic, in announcing the FDA’s approval for its PulseSelect PFA system, said the device has demonstrated a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AFib patients.”

From the public health and medical research front,

  • The New York Times offers readers’ perspectives on its article about the high and climbing number of pedestrian deaths occurring at night. “Readers share concerns like headlight glare, streetlight design and the aging of American motorists.”
  • HealthDay informs us,
    • “Diabetes drugs, including Ozempic, do not appear to increase the risk of birth defects
    • “Babies born of moms using drugs to control their type 2 diabetes had no greater risk of birth defects than those whose moms used insulin.
    • “Diabetes medications have grown in popularity over the past decade, particularly those in Ozempic’s class.”
  • The Director of the National Institute of Diabetes and Digestive and Kidney Diseases posted his Winter 2023 report.
  • Per Medscape,
    • “Living in food deserts and food swamps — areas with no access to healthy food, and areas with a plethora of unhealthy food options — may raise the risk of dying from postmenopausal breast cancer, a novel ecological study has found. 
    • “Food deserts and food swamps are both bad, but it’s worse in food swamps,” Malcolm Bevel, PhD, MSPH, with Augusta University in Georgia, told Medscape Medical News
    • “He presented his research here at the San Antonio Breast Cancer Symposium (SABCS) 2023.” 

From the U.S. healthcare business front,

  • KFF unveiled its updated
    • Health Spending Explorer, an interactive tool that allows users to explore trends in health spending by federal and local governments, insurers, nursing care, hospital, and other service providers, and consumers.
    • “The tool captures just-released 2022 data from the federal government, when national health expenditures totaled nearly $4.5 trillion. Overall spending rose 4.1% in 2022, with almost all categories of health spending experiencing growth. This rise was muted by lower federal public health spending related to the pandemic. Meanwhile, consumers’ out-of-pocket costs rose 6.6%, a large but less dramatic increase than in 2021.”
  • The Health Care Cost Institute reports,
    • “Healthcare spending continues to grow, and prices are the primary driver. Without addressing high and growing prices, efforts to make care more affordable will not be successful. One way to understand what is going on with prices in employer-sponsored insurance (ESI) is to compare negotiated rates paid in that market to Medicare payments for the same services. New analysis from the Health Care Cost Institute finds that, in 2021, ESI payments for outpatient services were, on average, 287 percent higher than Medicare payments.”
  • Beckers Hospital Review identifies the 25 largest health systems in the U.S. by number of beds, and provides the reasons for fourteen hospital closures.
  • Using the American Medical Association’s health insurance market concentration report, Beckers Payer Issues identifies the cities with the most competitive Medicare Advantage markets.
  • Reuters reports,
    • “Bluebird bio (BLUE.O) said on Thursday a large insurer had agreed to cover its newly approved sickle cell disease gene therapy, easing some investor worries about resistance from other payers over the high price of the treatment.
    • “Bluebird’s treatment, Lyfgenia, was approved along with another gene therapy Casgevy from partners Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics (CRSP.BN).
    • “Bluebird’s price of $3.1 million is nearly $1 million higher than its rival, despite Lyfgenia having a serious safety warning about blood cancer risk. That had raised concerns over whether it would get enough coverage from insurers versus its rival.”
  • and
    • “Drugmaker Novo Nordisk paid U.S. medical professionals at least $25.8 million over a decade in fees and expenses related to its weight-loss drugs, a Reuters analysis found. It concentrated that money on an elite group of obesity specialists who advocate giving its powerful and expensive drugs to tens of millions of Americans.”
  • The Employee Benefit Research Institute factors health savings accounts into the retirement funding picture for Americans.
  • Per Fierce Healthcare,
    • “Two months ago, Elevance Health and Blue Cross and Blue Shield of Louisiana hit the pause button on a potential $2.5 billion merger in the midst of regulatory scrutiny.
    • “The insurers brought the deal back to life this week, though, with BCBSLA filing an updated application on Thursday seeking to reorganize as a for-profit, which would allow it to be purchased by Elevance Health. Per the New Orleans Times-Picayune, many of the plan’s initial proposals remain, but BCBSLA has made changes to the planned nonprofit foundation that will roll out should it be finalized.
    • “The newspaper reported that the Accelerate Louisiana Initiative will receive 91% of the proceeds from the merger.
    • “In a joint statement to Fierce Healthcare, the companies said that the new “filing reflects the input and vision of our communities to ensure that we deliver on these commitments.”
  • and
    • “While its merger with Humana may have fallen through for now, Cigna is attracting plenty of interest for the rumored sale of its Medicare Advantage business, Bloomberg reported.
    • Sources close to the matter told the outlet that Health Care Service Corp. and Elevance Health are “competing” to scoop up the MA segment. Cigna is expecting that the final bids will be submitted next week, according to the report.
    • “Cigna’s Medicare Advantage unit could sell for more than $3 billion, according to Bloomberg. The article noted that talks with HCSC and Elevance Health may not ultimately lead to a sale.
    • “That Cigna was shopping for a potential buyer for its MA business was first reported in early November by Reuters. That report mentioned that Cigna could ultimately elect to hang on to the MA unit if it didn’t find an appealing deal.
  • The Institute for Clinical and Economic Review listed their top ten stories of 2023.

Monday Roundup

Photo by Sven Read on Unsplash

From Washington DC

  • The Wall Street Journal reports
    • “A bid by House Majority Whip Tom Emmer (R., Minn.) to serve as the House Republicans’ pick to be speaker will test whether the strong ties he built recruiting candidates and counting votes will overcome doubts from some anti-establishment lawmakers aligned with former President Donald Trump.
    • “Candidates are expected to pitch their colleagues at a forum on Monday evening ahead of an internal vote to designate a new Republican speaker nominee as soon as Tuesday morning. Beyond winning the GOP ballot, the speaker nominee will face the uphill battle to unite almost all Republicans to have a chance of winning the House vote, given Republicans’ narrow 221-212 majority.  * * *
    • “To become House speaker designate, the winning candidate must garner a majority of the votes cast within the Republican conference. The internal House GOP conference voting could go multiple rounds, with the candidate receiving the fewest number of votes dropping out after each round until a candidate wins 50% of the vote plus one. After that, the House speaker-designate must win support from a majority in the House, hitting 217 of the 433 House votes if all members show up and cast a vote for an individual.
    • “In an effort to prevent holdout candidates from delaying the process, GOP Rep. Mike Flood of Nebraska is circulating a unity pledge, which lawmakers can sign saying that they promise to back the party’s speaker designee in a House floor vote. His spokeswoman on Monday morning said that all of the candidates except [Rep. Gary] Palmer [R Alabama] have signed on.”
  • Govexec tells us
    • “Lawmakers from both parties last week revived legislation that would allow most federal employees who began their careers as temporary or seasonal workers to make catch-up contributions to their pensions so that they can retire on time.
    • “The Federal Retirement Fairness Act (H.R. 5995), introduced by Reps. Derek Kilmer, D-Wash., Gerry Connolly, D-Va., Don Bacon, R-Neb., and David Valadao, R-Calif., would allow employees enrolled in the Federal Employees Retirement System who began their careers in government as temporary workers to make catch-up contributions to their defined benefit pensions to cover for the time before they had permanent positions and were unable to contribute to their retirement accounts. The legislation was last introduced in 2021 but failed to garner support.”
  • Labor Department Assistant Secretary for Employee Benefits Security Lisa Gomez writes in her blog about Breast Cancer Awareness Month.
  • BioPharma Dive informs us,
    • “The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizer’s shot Penbraya in teenagers and young adults for protection against the five most common disease-causing serogroups.
    • “Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. While meningococcal disease is rare, it can be serious and even deadly.
  • EMPR adds that the “Food and Drug Administration (FDA) has approved Zituvio (sitagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
  • Per Medtech Dive,
    • Medtronic said Monday it received approval from the Food and Drug Administration for an extravascular defibrillator designed to treat abnormal heart rhythms and prevent sudden cardiac arrest, which can lead to death within minutes if not treated immediately.
    • Unlike traditional implantable cardioverter defibrillators, which have lead wires running between a pulse generator and the heart, Medtronic’s Aurora EV-ICD places a lead outside of the heart and veins.
    • The Aurora EV-ICD was a PMA submission to the FDA, Medtronic spokesperson Tracy McNulty said in an email. “We estimate the current global EV-ICD market to be between $300-$350 million, and expect the EV-ICD market to reach $1 billion 10 years out from the Aurora launch,” McNulty said.

From the public health / research front,

  • MedPage Today points out,
    • “Children infected with the Omicron variant of SARS-CoV-2 appear to be infectious for about 3 days after a positive test, researchers found.
    • “In a small study of 76 kids ages 7 to 18, the median duration of infectivity was 3 days for both vaccinated and unvaccinated children, Neeraj Sood, PhD, of the University of Southern California, and colleagues reported online in a JAMA Pediatrics research letter.
    • “The vast majority of children who get COVID are symptomatic for 1 to 3 days,” co-author Eran Bendavid, MD, MS, of Stanford University, told MedPage Today. “Basically that correlates with how long the virus is causing disease in their body.”
  • and
    • “Maternal mRNA COVID-19 vaccination during pregnancy was associated with lower risks of poor neonatal outcomes, including neonatal death, according to a population-based retrospective cohort study from Canada.”
  • Health Day notes,
    • “Gun homicide rates went down in 2022, following increases reported during the pandemic.
    • “But race still played an outsized role, with Black people continuing to have the highest firearm homicide rates, and by a wide margin.
    • “American Indian/Alaska Natives were the only groups to see an increase again in 2022.
  • The Wall Street Journal reports
    • “The age women start taking menopausal hormone therapy and the kind they take might affect their chances of developing dementia later in life, a new study found.
    • “Women have struggled for years with whether to take hormone therapy when they go through menopause. The medication can help relieve troubling symptoms such as hot flashes and night sweats. However, years of conflicting research on whether the therapy can lead to other health problems, including breast cancer, dementia and heart attacks, has left many women confused about what to do.
    • “This new study suggests that hormone therapy might lower—or at least not raise—your dementia risk if you take it in midlife. For older women, the study found some signs that the medication might raise it.
  • mHealth Intelligence explains that “The shift to telebehavioral healthcare during the COVID-19 pandemic is linked to fewer disruptions in psychotherapy services, indicating telehealth can be effective in supporting the continuity of these services, a new study shows.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Physicians’ decisions to leave their practices is a complex choice “with multiple interdependent factors,” and is not solely impacted by burnout, pay or frustrations with electronic health records, according to a new qualitative study published in ​​the Journal of the American Board of Family Medicine.
    • “The study, which interviewed physicians who left their ambulatory care practices between 2018 and 2021, found that they were motivated to increase time off, have more flexibility or receive higher earnings. However, other departing physicians reported higher compensation would not have persuaded them to stay.
    • “Physician practices can better retain clinicians by addressing risk factors for departure including workflow distribution across team members and ensuring adequate staffing, the report said.”
  • The Wall Street Journal reports,
    • Roche Holding has agreed to buy the developer of a bowel-disease treatment from Roivant Sciences, a company started by Republican presidential candidate Vivek Ramaswamy, and Pfizer in a deal worth more than $7 billion.
    • “The Swiss pharmaceutical giant said Monday it would pay $7.1 billion upfront for Telavant Holdings and make a near-term milestone payment of $150 million. Roche said the deal gives it rights to commercialize Telavant’s RVT-3101 drug candidate, which has shown promise for inflammatory bowel disease and could have potential in other indications in the U.S. and Japan. 
    • “The deal is the latest example of a big pharma company turning to the deal table to bolster its pipeline of autoimmune drugs. Merck earlier this year agreed to pay more than $10 billion to buy Prometheus Biosciences, which is developing a drug for inflammatory bowel disease that would compete with Telavant’s candidate.”
  • Per Fierce Healthcare
    • “Folx Health, a virtual provider focused on LGBTQ+ health, is now in-network with Cigna, Evernorth and Blue Shield of California.
    • “Other payer partners include Blue Cross and Blue Shield of Texas and Optum for behavioral health service in Colorado and Florida, according to Folx Health’s website. Through the collaboration, insured patients can use therapy and mental health medication management with Folx’s LGBTQ-specialized clinicians. 
    • “Folx offers virtual primary care, gender-affirming care and mental health services. Making that care in-network will deliver its patients significantly lower out-of-pocket costs, per the company.”
  • Assured Partners offers HSA and FSA Account Reminders for Year-End.

Weekend update

From Washington, DC,

  • The Senate is on State work break this week, while the House of Representatives is focusing on electing a new Speaker on Wednesday October 11.
  • The Motley Fool tells us,
    • “The most important day of the year for the more than 66 million people who receive a Social Security benefit each month is nearly here. This coming Thursday, Oct. 12, 2023, at 08:30, a.m., ET, the Social Security Administration (SSA) will announce the 2024 cost-of-living adjustment (COLA). * * *
    • “Suffice it to say, the 2024 Social Security COLA isn’t going to be anywhere close to [2023’s historic] 8.7%. It will, however, be an above-average boost to benefits.
    • “According to the latest estimate from Mary Johnson, senior Social Security policy analyst at The Senior Citizens League (TSCL), a nonpartisan senior advocacy group focused on advancing issues important to seniors, the program’s COLA is expected to hit 3.2% for 2024. Over the past 20 years, Social Security’s COLA has averaged just 2.6%.”  

From the public health front,

  • The Washington Post informs us,
    • “In a sobering analysis, researchers warn that those who’ve had childhood cancer are highly likely to face physical and mental health challenges later in life, with 95 percent developing a “significant health problem” related to their cancer or treatment by age 45.”In a sobering analysis, researchers warn that those who’ve had childhood cancer are highly likely to face physical and mental health challenges later in life, with 95 percent developing a “significant health problem” related to their cancer or treatment by age 45.
    • “The researchers reviewed 73 studies, including 39 cohort studies that followed patients over time. Publishing their findings in JAMA, they said approximately 15,000 children and adolescents through age 19 are diagnosed with cancer every year and that 85 percent of children now live five years or more beyond their diagnosis. That’s compared with just 58 percent in the 1970s, according to the American Cancer Society.
    • “The research documented a variety of concerns for young cancer survivors, ranging from subsequent hormone issues to reproductive health challenges, problems with muscles and bones, cognitive impairment and more.”
  • The New York Times lets us know,
    • “A new study has an encouraging message for Americans who shy away from Covid shots because of worries about side effects: The chills, fatigue, headache and malaise that can follow vaccination may be signs of a vigorous immune response.
    • “People who had those side effects after the second dose of a Covid vaccine had more antibodies against the coronavirus at one month and six months after the shot, compared with those who did not have symptoms, according to the new study. Increases in skin temperature and heart rate also signaled higher antibody levels”
  • MedPage Today explains why utilizing artificial intelligence may reduce maternal and infant mortality.
    • “For example, “One of the biggest threats to maternal and infant health is the unmet needs within the social determinants of health, which often directly influence mothers’ ability to access healthcare services. If a pregnant woman doesn’t have access to reliable transportation to get her to and from the doctor or lives a significant distance from one, AI can measure how that might impact health outcomes for her and her unborn child. Then, it can flag it for her doctor or health plan so they can help solve these issues before they cause larger problems.
    • “The result? Reduced racial disparities for maternal health, fewer preterm births and neonatal intensive care unit (NICU) admissions, and shorter NICU stays.” 
  • Medscape reports,
    • “Once weekly glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide (Ozempic, Novo Nordisk) significantly improved A1clevel and body weight for up to 3 years in a large cohort of adults with type 2 diabetes, show real-world data from Israel.
    • “Treatment with semaglutide was associated with reductions in both A1c (-0.77%; P < .001) and body weight (-4.7 kg; P < .001) at 6 months of treatment. These reductions were maintained for up to 3 years and, in particular, in those patients with higher adherence to the therapy.
    • “Avraham Karasik, MD, from the Institute of Research and Innovation at Maccabi Health Services, Tel Aviv, Israel, led the study and presented the work as a poster at this year’s annual meeting of the European Association for the Study of Diabetes (EASD).”

From the U.S. healthcare business front

  • Forbes reports
    • “Uber Health is partnering with UnitedHealth Group’s Optum health services business to make paying for ancillary benefits like ride share and product delivery easier for seniors via the Uber app.
    • “Health plan benefit cards, including health spending account (HSA) and flexible spending (FSA) cards, can be added as a form of payment within the Uber app,” Optum and Uber said in statement released Sunday during HLTH 2023 in Las Vegas. “This payment option can then be used to cover eligible expenses, including health related rides (like non- emergency doctor visits), over-the-counter items and healthy food.”
  • Per Healthcare Dive,
    • “Rite Aid on Wednesday said it has failed to meet the New York Stock Exchange’s continued listing standards. The retailer is no longer in compliance with NYSE standards on minimum stock price and market capitalization. The NYSE listing standards require a $1.00 average closing share price over a 30 trading-day period. 
    • “As of midday Thursday, Rite Aid’s stock was trading at about 50 cents on the NYSE. Rite Aid now has 10 business days to formally confirm if it will seek to regain compliance and six months to do so. But the company said it, “can provide no assurances that it will be able to regain compliance with the NYSE’s continued listing standards.”
    • “News that Rite Aid faces delisting comes weeks after reports emerged that the company, which has $3.3 billion in debt, may seek to close up to 500 of its 2,200 locations as part of a possible Chapter 11 bankruptcy filing.”