Midweek Update

Medical / Rx research

Midweek Update

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today lauded committee passage of the Better Mental Health Care, Lower Drug Cost, and Extenders Act, which was reported out of committee 26-0.” 
  • “The legislation expands mental health care and substance use disorder services under Medicaid and Medicare, reduces prescription drug costs for seniors at the pharmacy counter, extends essential Medicaid and Medicare provisions that will expire this year, and increases Medicare payments to support physicians and other providers. * * *
  • “Click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • Fierce Healthcare adds,
    • “Under the Senate Finance proposal, the $8 billion in cuts to hospitals through the Medicaid disproportionate share hospital (DSH) payments will be eliminated, saving providers $16 billion over the next two years, according to the mark released earlier this week.
    • “Hopefully in further discussion Senators will decide not to pursue so-called ‘site neutral’ policies,” said Federation of American Hospitals President and CEO Chip Kahn in a statement. “This is no time for hospital cuts – particularly for struggling hospitals serving rural America. This ‘one-size-fits-all’ policy will ultimately threaten service resulting in limits on access to care for seniors and others who are better served receiving necessary treatment in the hospital. “
    • “The draft also includes decreasing physician reimbursements by 1.25%, a reduction from larger cuts that could better appease physician interest groups.”
  • STAT News reports
    • “Eli Lilly’s blockbuster drug tirzepatide, sold as Mounjaro for type 2 diabetes [and nicknamed the Godzilla of GLP-1 drugs], has been cleared to treat obesity, making it the second in a highly effective class of weight loss medications to enter the market.
    • “The Food and Drug Administration’s long-awaited approval of the injectable drug, which will be marketed under the name Zepbound for obesity, is a milestone for Lilly. It also introduces stiff competition for Novo Nordisk, which has had to limit starter doses of its obesity treatment Wegovy due to ongoing shortages. * * *
    • “Lilly will sell Zepbound at a list price of $1,059.87 per month, about the same price as Mounjaro and about 20% lower than the price of Novo’s Wegovy. Lilly is also introducing a savings card program for people with commercial insurance.
    • “Lilly expects the drug to be available in American pharmacies after Thanksgiving. In an effort to prevent future shortages, the company plans to have roughly doubled its manufacturing capacity by the end of the year, CEO David Ricks said on a conference call with reporters. Only about 5 million people in the U.S. receive any form of GLP-1 treatment, Ricks said, but there are roughly 50 million Americans who would be eligible for Zepbound and who have commercial insurance that covers obesity treatments.
    • “We know with such an effective medication there’ll be a lot of demand,” Ricks said. “We’re stepping up to that challenge and hope to fulfill it in the coming years.”
  • Ka-ching!!
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC) today released three reports focusing on different groups of women in the federal government: American Indian and Alaska Native (AIAN) women, African American women, and Hispanic women and Latinas.
    • “The reports examined fiscal year (FY) 2020 data to compare the participation, retention, advancement, and pay of each group of women to three different groups: the total federal workforce, all women, and men of the same ethnicity or race. Results show that employment outcomes for these three groups of women were not equal to the comparison groups. Understanding the challenges these groups of women face in the federal workplace can help agencies better address these inequalities.”

From the public health and research front,

  • The Wall Street Journal reports that children in mental health crises have been surging into hospital emergency rooms.
    • “Broadly, children’s demand for emergency mental-health services has eased from the pandemic’s extreme highs, according to an analysis of records across more than 1,100 hospitals by the research arm of Epic Systems, a medical record software company. Still, the rates remain elevated. 
    • “For adults, the data on trips to emergency departments for psychiatric reasons during the pandemic is limited, but doctors say they are more used to seeing such cases. E.R.s aren’t accustomed to seeing large numbers of children in psychiatric crisis—and many are ill-equipped to handle them.”
  • STAT News reports,
    • “The radiopharmaceutical world is now approaching critical mass. There are currently around 75 such startups in the U.S., several of which have raised sizable financing rounds this year. In September, RayzeBio managed to complete an IPO — rare amid an industry slump — raising $358 million. Bayer has made a few acquisitions in the field. And last month, pharmaceutical giant Eli Lilly jumped in, acquiring Point Biopharma and its Phase 3 radiopharmaceutical treatment for prostate cancer for $1.4 billion.
    • “Investors and executives are optimistic these investments will pay off not just for venture capitalists, but for cancer patients. But just how much they can benefit the field remains to be seen. To achieve anything, radiopharmaceutical companies must hurriedly address supply and production challenges — issues that have handicapped other promising areas of oncology drug development.”
  • and
    • Vaccines work well to prevent cancers caused by the human papillomavirus (HPV). So well, in fact, that it may be time to review HPV screening protocols, according to the somewhat provocative conclusion of a new study examining the occurrence of genital HPV types eight years after immunization, published Wednesday in Cell Host & Microbe.
  • and
    • “In American health care, overtreatment is common. Recently though, there has been a subtle shift in the opposite direction. It’s possible that “less is more” is catching on.
    • “Now, some providers are asking what the line between necessary and unnecessary really is. The results are encouraging, suggesting that, in some cases, it may be possible to achieve the same health outcomes with less treatment — and fewer side effects, too.
    • “This shift is particularly noticeable in cancer care.”
  • Here is a link to the National Cancer Institute’s latest research update.
  • Gallup announced
    • “U.S. workers are optimistic that employer-sponsored wellness initiatives could enhance their wellbeing, according to data from the Bentley-Gallup Business in Society Report. When asked to rate the potential impact of six wellness initiatives on wellbeing, the top three most positively rated (based on combined extremely and somewhat positive ratings) are employers offering a four-day workweek option (77%), providing mental health days (74%) and limiting the amount of work employees are expected to perform outside of work hours (73%).”
  • Becker’s Payer Issues tells us,
    • “Increasing Medicare Advantage enrollment in rural areas did not increase rural hospitals’ financial distress or risk of closing, a study published Nov. 3 in the American Journal of Managed Care found. 
    • “Researchers studied rural hospitals in 14 states from 2008 to 2019. Medicare Advantage enrollment in rural hospital counties increased from 14.3% of Medicare beneficiaries in 2008 to 28.4% in 2019. The percentage of Medicare inpatient stays paid for by MA plans increased from 6.5% in 2008 to 20.6% in 2019. 
    • “The researchers found that when Medicare Advantage penetration increased by 1% in a county, hospitals’ financial stability increased slightly, and they experienced a 5% reduction in risk of closing. 
    • “One in 5 of the hospitals studied treated no Medicare Advantage patients during the study period.” 

From the U.S. healthcare business front,

  • The Segal Company highlights fraud, waste, and abuse trends in this fourth quarter of 2023.
  • Healthcare Dive provides the biggest takeaways from health insurers’ third-quarter earnings.
  • KFF offers
    • “One new analysis shows that the typical beneficiary has a choice of 43 Medicare Advantage plans as an alternative to traditional Medicare for 2024. That is the same number available as in 2023, but more than double the number of plans offered in 2018, which shows how this market is attractive to both enrollees and insurers.
    • “In addition, the typical person covered under traditional Medicare can choose among 21 Medicare stand-alone prescription drug plans (PDPs), the second analysis shows. The number of PDP options for 2024 is lower and the number of Medicare Advantage prescription drug plan (MA-PD) options is higher than in any other year since Part D started, reflecting the broader trend toward Medicare Advantage.”
  • Fierce Healthcare informs us,
    • “A recent federal district court ruling against the office overseeing the 340B Drug Pricing Program has opened the doors for hospitals to more broadly claim discounts, healthcare legal experts say.
    • “The decision in Genesis Healthcare, Inc. v. Becerra, handed down Friday by the U.S. District Court of South Carolina, establishes that “at least some of [the] interpretative policies surrounding the 340B definition of the patient are inconsistent with the 340B statute,” Anil Shankar, a partner at Foley & Lardner, told Fierce Healthcare.
    • “This is a stunning decision that will have the attention of every 340B stakeholder,” he said. “… This creates new opportunities for 340B-covered entities to purchase 340B for their patients and suggests that [the Health Resources and Services Administration’s (HRSA’s)] audit processes will need to change.”
  • and
    • “Building on its One Medical deal, Amazon is now offering a One Medical for Prime membership, including 24/7 virtual care, for $9 per month, or $99 a year. That’s $100 less than the standard One Medical membership fee, according to the company.
    • “Prime members can add up to five additional memberships, each for just $6 a month, or $66 annually.
    • “The One Medical for Prime membership fee covers unlimited access to 24/7 virtual care nationwide, including video chats with licensed providers and access to an in-app “Treat Me Now” feature that lets users get fast care for common concerns like cold and flu, skin issues, allergies, urinary tract infections.”

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Roll Call informs us,
    • “House Republicans are aiming to reach a consensus this week on a stopgap funding measure that would get a vote next week before the current continuing resolution runs out on Nov. 17.
    • “During a Monday night leadership meeting, Speaker Mike Johnson, R-La., floated a “laddered CR” that would extend funding for four bills through Dec. 7 and the rest through Jan. 19. Johnson said Tuesday after meeting with the GOP conference that a stopgap bill running into January “with certain stipulations” is also on the table.
    • “The new speaker said he would be revealing his spending plan “in short order” but did not share any details Tuesday morning after House Republicans met to discuss the options. However, Senate Democrats are pushing for a stopgap measure into early December, with Dec. 8 as the preferred end date, according to sources familiar with the consideration.”
  • The Washington Post reports,
    • “The Senate on Tuesday voted 62 to 36 to confirm cancer surgeon Monica M. Bertagnolli as the director of the National Institutes of Health, ensuring that America’s flagship biomedical agency will have a permanent leader following a months-long dispute involving a key senator that threatened to derail her nomination.
    • “Bertagnolli will be the second woman ever to lead the nearly $48 billion agency, which plays a central role in the U.S. scientific agenda by funding grants to hundreds of thousands of researchers, overseeing clinical trials on its Maryland campus and supporting other endeavors to develop drugs and therapeutics.”
  • The U.S. Preventive Services Task Force gave brand new “inconclusive” recommendations to the following services:
    • The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening performed by primary care clinicians for oral health conditions, including dental caries or periodontal-related disease, in adults.
    • The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening performed by primary care clinicians for oral health conditions, including dental caries, in children and adolescents aged 5 to 17 years.
  • Federal News Network points out,
    • “In October, 6,924 new [federal and postal retirement] claims were filed, an increase of 156 more than September. OPM also processed fewer retirement claims last month. The agency said it processed 6,098 claims, a  2,781 drop from the previous month.
    • “Initial retirement cases in October completed in less than 60 days on average took 42 days to process, up 2 days from the previous month, while initial cases that were processed in more than 60 days on average took 113 days.  That’s a 9 day improvement from September.
    • “Along with the increase of the claims backlog, the monthly average processing time in days grew from 70 to 73. But there is some good news: The fiscal year-to-date average processing time in days decreased from 77 to 73 days in October.”

In FEHBP news,

  • Per the Federal Times,
    • “Millions of federal employees and their family members will be able to shop for health benefits beginning Monday. 
    • “Open enrollment, spanning for four weeks, could overlap with a government shutdown if Congress fails to extend the current continuing resolution or pass a spending package by next Friday. More than a month into fiscal 2024, the government is still operating on last year’s funding levels after Congress passed a last-minute stopgap bill on Sept. 30.
    • “As the name implies, a shutdown means that many agency offices close and employees whose work is outside of national security, health and “life or death” services are sent home without pay. However, the office that oversees the Federal Employee Health Benefits program and open season is funded by a trust that does not rely on annual appropriations.
    • “There are sufficient amounts in these trust funds to operate them throughout the duration of any lapse in appropriations,” according to the White House’s Office of Personnel Management.
    • “Thus, employees will be able to participate in open season in the event of a shutdown. And coverage will not lapse during this time either, either for medical or dental and vision.”
  • Federal News Network considers, in consultation with Kevin Moss from Consumers’ Checkbook, “six reasons feds why should take a look [at available FEHB plans] during Open Season this year.”

From the public health and research front,

  • The American Hospital Association News tells us,
    • “Over 3,700 babies were born with syphilis in 2022, 32% more than in 2021 and 10 times more than in 2012, the Centers for Disease Control and Prevention reported Nov. 7. Almost 9 in 10 cases last year could have been prevented with timely testing and adequate treatment, the agency said, and urged emergency departments, syringe service programs, prisons/jails and maternal and child health programs to use rapid syphilis testing and treatment during pregnancy and other settings to consider immediate treatment if a patient tests positive and faces obstacles to ongoing care.
    • “The congenital syphilis crisis in the United States has skyrocketed at a heartbreaking rate,” said CDC Chief Medical Officer Debra Houry, M.D. “New actions are needed to prevent more family tragedies. We’re calling on healthcare providers, public health systems, and communities to take additional steps to connect mothers and babies with the care they need.” 
  • The National Institutes of Health announced,
    • “In a small study, researchers at the National Institutes of Health have found that positron emission tomography (PET) scans of the heart may identify people who will go on to develop Parkinson’s disease or Lewy body dementia among those at-risk for these diseases. The findings, published in the Journal of Clinical Investigation and led by scientists at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH, may advance efforts to detect the earliest changes that years later lead to Parkinson’s disease and Lewy body dementia.
    • “In 34 people with Parkinson’s disease risk factors, researchers conducted PET scans of the heart to gain insight into levels of the neurotransmitter norepinephrine. They found that the scans could distinguish individuals who would later be diagnosed with Parkinson’s or Lewy body dementia—both are brain diseases caused by abnormal deposits of the protein alpha-synuclein that form clumps known as Lewy bodies. The research was conducted at the NIH Clinical Center, currently the only location for F-dopamine PET scanning.”
  • The Wall Street Journal reports on ways to control sugar consumption
    • People assume they can build up the willpower to completely avoid sweets or restrict them to tiny amounts, but cutting them out increases the chances of overeating later, says Dr. Judson Brewer, a neuroscientist and psychiatrist at Brown University and author of a forthcoming book about eating habits. 
    • “Willpower is more myth than muscle,” says Brewer.
    • “Unsurprisingly, a fully permissive approach to sugar won’t work for kids, says Crystal Karges, a San Diego-based dietitian who works with families. Still, she doesn’t encourage restriction. One strategy she suggests is to offer sweets alongside regular meals in order to normalize the treats. 
    • “Brewer, the neuroscientist, suggests another alternative to restricting yourself: Find your “pleasure plateau.” Rather than cutting out treats entirely, train yourself to pay close attention to how a treat is tasting as you eat it and note when you stop enjoying the taste of it. 
    • “Practicing attentive eating or mindfulness over time can help your body feel the rewards of limiting sugar consumption, which can be anything from having more energy to fewer cravings to weight loss, Brewer says. 
    • “Keeping your home well-stocked with healthy snacks, alongside indulgent treats, is helpful. In her own home, [University of Minnesota professor Dianne] Neumark-Sztainer says roughly 70% of the food options are nutritious and lack added sugar, including whole grains, fruits and vegetables. 
    • “She doesn’t recommend most people count the amount of sugar they eat each day, which can increase anxiety. “Try to look at the whole picture and not to make a big deal about it,” she says.”

From the U.S. healthcare business front,

  • Per STAT News,
    • “Sage Therapeutics set the price of Zurzuvae, its recently approved treatment for postpartum depression, at $15,900 for a 14-day course of therapy. The once-daily pill will be launched in December, co-marketed with Biogen. 
    • “Eisai reported sales of 300 million yen ($2 million) for Leqembi, its treatment for Alzheimer’s disease, in the company’s fiscal second quarter. Approximately 800 people were receiving treatment with Leqembi as of Oct. 27, the company said.” 
  • Beckers Payer Issues ranks the major health insurers by third-quarter medical loss ratios.
  • Per Healthcare Dive,
    • “E-prescribing giant Surescripts has acquired ActiveRADAR, a company that aims to find cheaper medication alternatives.
    • “ActiveRADAR, formerly known as RxTE Health, evaluates drugs in 165 therapeutic categories to identify clinical equivalents, then uses health plan-specific data to determine alternative medications that could reduce costs for employers and patients, according to the company.
    • “The deal, announced on Monday, makes ActiveRADAR a wholly owned subsidiary of Surescripts, according to a company spokesperson. Terms of the deal weren’t disclosed.”
  • Forbes offers “Five considerations for health plan leaders using AI-enabled prior authorization and utilization management.”

Monday Roundup

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

From Washington, DC,

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

From the public health and research front,

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

From the U.S. healthcare business front,

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

Weekend Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC

  • Tomorrow afternoon, the House Rules Committee will take up HR 4664, the financial services and general government appropriations bill that includes OPM and FEHB funding. The bill includes the typical FEHB appropriations provisions — the abortion coverage restriction, the contraceptives coverage mandate, and the prohibition against applying full Cost Accounting Standards coverage to experience-rated FEHB plan carriers.
  • The Federal Benefits Open Season begins next Monday, November 13, and ends on Monday, December 11, 2023. OPM has refreshed the Open Season website with 2024 plan information.

From the public health and research front,

  • NPR Shots discusses the impact of chronic drug shortages on hospitals and patients.
  • The Washington Post reports that “the hunt quickens” for vaccines and antibody therapies against opioids. For example,
    • “The federal government recently awarded an additional $14.8 million for research into a monoclonal antibody that would target fentanyl — the nation’s deadliest street drug — by binding to its molecules before they can invade the brain and shut down breathing. Cessation Therapeutics, a North Carolina biotech company, touts its monoclonal antibody as a way both to prevent overdoses and to treat overdoses and opioid addiction.”
  • Fortune Well tells us,
    • “Whether you snag some vitamin C at the first sign of a cold or stock up on probiotics to keep your gut health in check, you’re not alone in turning to dietary supplements—an estimated 75% of Americans use them.
    • “Among the various types, vitamin K is gaining popularity due to its potential benefits for healthy aging. Specifically, it is thought to aid in the prevention of age-related conditions such as osteoporosis and cardiovascular disease.”
  • Medscape informs us,
    • “Prescriptions for semaglutide jumped 150% in the past year, with an 80% increase in prescriptions written per provider, new data suggest.
    • “Among more than 350,000 prescribers in the nationwide DrFirst network between December 2022 and June 2023, prescriptions for the weight loss formulation Wegovy rose sixfold while those for Ozempic, the lower-dose version for treating type 2 diabetes, increased by 65%.”
  • and
    • “With nutrient-stimulated hormone therapies for obesity in phase 3 trials and activin-receptor inhibitors in the next upcoming drug class, highly effective treatments for obesity are on the horizon.
    • “We are at a watershed [moment] brought on by the recent introduction of highly effective antiobesity medications,” said Ania M. Jastreboff, MD, PhD, in a lecture at ObesityWeek.
    • “Jastreboff, from Yale University and the Yale Center for Weight Management, New Haven, Connecticut, provided an overview of the many nutrient-stimulated hormone-based antiobesity therapies in late phases of development — including dual and triple therapies with glucagon-like peptide 1 receptor agonists (GLP-1 RAs), glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon, and amylin.”
  • and
    • “New research suggests terminating metformin may raise the risk for dementia in older adults with type 2 diabetes, providing more evidence of metformin’s potential neuroprotective effects.”
  • and, last but not least,
    • “T3D-959, an oral dual delta/gamma peroxisome proliferator-activated nuclear receptor (PPAR) agonist, has shown promise in a phase 2 randomized, placebo-controlled study of adults with mild-to-moderate Alzheimer’s disease (AD).”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson said Thursday that Republicans are considering a new approach to stopgap funding that would extend pieces of current appropriations for different time periods, effectively setting up a series of funding cliffs while avoiding a single deadline that could trigger a partial government shutdown for all agencies.
    • “With current funding for the entire government set to expire on Nov. 17, Johnson has proposed a CR to extend funding through Jan. 15, though that date is the federal Martin Luther King Day holiday. But the Louisiana Republican said at a press conference some GOP members raised the idea of a “laddered CR” to extend funding on a piecemeal basis.”
  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released a discussion draft including policies aimed at expanding mental health care under Medicaid and Medicare and reducing prescription drug costs for seniors at the pharmacy counter. The package also includes essential Medicaid and Medicare provisions that will expire this year, as well as changes to Medicare payment to support physicians and other professionals. The Committee intends to advance these legislative proposals, in addition to pharmacy benefit manager (PBM) reforms previously passed out of the Committee in July, and pursue full Senate passage and enactment. As part of that process, the Committee intends to hold a markup on Wednesday, November 8 at 10 a.m. In keeping with Finance Committee rules, the Chairman’s Mark will be released 48 hours in advance of the markup.”
  • It was a very busy day for the Centers for Medicare and Medicaid Services. We learned from the American Hospital Association that
    • The Centers for Medicare & Medicaid Services Nov. 2 issued a final rule that increases Medicare hospital outpatient prospective payment system rates by a net 3.1% in calendar year 2024 compared to 2023. This includes a 3.3% market basket update, offset by a 0.2% cut for productivity.
    • In a statement shared with the media, AHA Executive Vice President Stacey Hughes said “The AHA is concerned that CMS has again finalized an inadequate update to hospital payments. Today’s increase for outpatient hospitals of only 3.1% comes in spite of persistent financial headwinds facing the field. Most hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging day to day. Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, which is why the AHA is urging Congress for additional support by the end of the year.” 
    • The rule also finalizes several changes to the hospital price transparency rule, including requiring a new standard format with an additional data element and a completeness and accuracy affirmation statement. CMS also makes updates to streamline the enforcement process. Compliance dates for the changes range from Jan. 1, 2024, to Jan. 1, 2025. Most formatting changes take effect July 1, 2024.
  • and
    • “Following last year’s unanimous Supreme Court decision in favor of the AHA and others, the Department of Health and Human Services Nov. 2 issued a final rule outlining the agency’s remedy for the unlawful payment cuts to certain hospitals that participate in the 340B Drug Pricing Program. 
    • “HHS’ final rule contains two central components. First, HHS will repay 340B hospitals that were unlawfully underpaid from 2018 to 2022 in a single lump sum payment. The final rule contains the calculations of the amounts owed to the approximately 1,600 affected 340B covered entity hospitals. Second, HHS finalizes a policy to recoup funds from those hospitals that received increased rates for non-drug services from 2018 to 2022. HHS will recoup these funds by adjusting the outpatient prospective payment system conversion factor by minus 0.5% starting in calendar year 2026 (one year later than HHS had originally proposed and as AHA advocated), making this adjustment until the full amount is offset, which the department estimates to be 16 years.
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “Following years of litigation and a unanimous Supreme Court win, the AHA is very pleased that 340B hospitals finally will be reimbursed in full for what HHS unlawfully withheld from them for five years. The one-time, lump-sum repayment hospitals will soon receive will help them to continue providing high-quality care to their patients and communities. However, HHS made a grievous mistake in choosing to claw back billions of dollars from America’s hospitals, especially those that serve rural, low-income and other vulnerable communities. HHS decided to ignore hundreds of comments from hospitals and other providers explaining why this Medicare cut is both illegal and unwise. The AHA will continue to review this rule and consider all available options going forward.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 2 released its calendar year 2024 final rule for the physician fee schedule. The rule will cut the conversion factor by 3.4%, to $32.74 in CY 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a budget-neutrality adjustment. 
    • “As urged by the AHA, CMS addressed the fact that on Jan. 1 practitioners who render telehealth services from home would have been required to report their home address on enrollment and claims forms. The agency delayed this provision until Jan. 1, 2025, and solicits comments on the issue for future rulemaking.
    • “In addition, the agency finalized a revised definition of the substantive portion of a split (or shared) visit. Specifically, for CY 2024, for purposes of Medicare billing, the definition of “substantive portion” means more than half of the total time spent by the physician and non-physician practitioner performing the split (or shared) visit or a substantive part of the medical decision-making.
    • “CMS finalized its proposals to advance access to behavioral health services. First, CMS will implement regulations as directed by the Consolidated Appropriations Act of 2023 to create a new benefit category for marriage and family therapists and mental health counselors under Part B, who will be eligible to provide telehealth services and behavioral health integration services. CMS also established new payment codes for mobile psychotherapy for crisis services as required by the CAA. Separately, the agency will apply an adjustment to psychotherapy services payments billed with a new increased complexity code and will increase the payment rate for the substance use disorder bundle.”
  • What’s more, AHA News reports,
    • “The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, Nov. 2 sued the federal government to bar enforcement of an unlawful, harmful and counterproductive rule that has upended hospitals’ and health systems’ ability to share health care information with the communities they serve, analyze their own websites to enhance accessibility, and improve public health.  * * *  
    • “Today’s lawsuit challenges a “Bulletin” issued by HHS’ Office for Civil Rights. The December 2022 “Bulletin” restricts hospitals from using standard third-party web technologies that capture IP addresses on portions of hospitals’ public-facing webpages that address health conditions or health care providers. For example, under HHS’ new rule, if someone visited a hospital website on behalf of her elderly neighbor to learn more about Alzheimer’s disease, a hospital’s use of any third-party technology that captures an IP address from that visit would expose that hospital to federal enforcement actions and significant civil penalties.”  
  • The U.S. Office of Personnel Management announced “the recipients of the 2023 Presidential Rank Awards (PRA) chosen by President Joe Biden. The PRAs are one of the most prestigious awards in the career civil service, recognizing the important contributions of public servants across the federal government.” Congratulations to the recipients.   

In FEHB news, FedWeek discusses the relationship between FEHBP and FEDVIP plans.

  • “FEDVIP is the “secondary” payer to any benefits provided under an FEHB plan. If you are enrolled in both FEDVIP and FEHB, you must provide your FEHB enrollment information during the FEDVIP enrollment process (which takes place online, on www.benefeds.com). It’s a good idea to provide your FEHB information to the medical office that is providing the dental or vision services under FEDVIP.
  • “Also, if you change your FEHB health plan during the year, you need to notify BENEFEDS immediately. If you fail to provide this information, payment of claims will be delayed.”

From the public health and research front,

  • The U.S. Preventive Services Task Force released its final research plan for “Healthy Diet, Physical Activity, and/or Weight Loss to Prevent Cardiovascular Disease in Adults: Behavioral Counseling Interventions.”
  • The NIH Director’s Blog discusses “How Double-Stranded RNA Protects the Brain Against Infection While Making Damaging Neuroinflammation More Likely.”
    • “The findings show how this tricky balance between susceptibility to infection and inflammation in the brain works in both health and disease. It also leads to the tantalizing suggestion that treatments targeting these various players or others in the same pathways may offer new ways of treating brain infections or neuroinflammatory conditions, by boosting or dampening dsRNA levels and the associated immune responses. As a next step, the researchers report that they’re pursuing studies to explore the role of dsRNA-triggered immune responses in ALS and Alzheimer’s, as well as in neuropsychiatric symptoms sometimes seen in people with lupus.”
  • The Food and Drug Administration released
    • “data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings, which were collected between March and June 2023, show that 10% of U.S. middle and high school students (2.8 million youth) reported current use of any tobacco product.
    • “Among U.S. high school students, current overall tobacco product use declined during 2022-2023 (16.5% to 12.6%). This decline was primarily attributable to reduced e-cigarette use (14.1% to 10%), which translates to 580,000 fewer high school students who reported current use of e-cigarettes in 2023. Among high school students, declines in current use were also observed during 2022-2023 for cigars and overall combustible tobacco smoking, representing all-time lows.”
    • “It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “But we can’t rest on our laurels. There’s more work to be done to build on this progress.”  

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Cigna has hiked its membership expectations for 2023. The health insurer previously expected to lose commercial members in the back half of the year, prepping for an economic downturn that might cause Americans to lose their jobs — and subsequently, their insurance.
    • “But the expected economic downturn has yet to materialize, leading Cigna to say on Thursday it expects to add at least 1.6 million members this year, up 200,000 lives from previous forecasts.
    • “We’ve not seen the disenrollment levels we incorporated into our prior outlook,” said CFO Brian Evanko on a Thursday call with investors. Cigna also raised its revenue and adjusted earnings per share outlook for 2023, after releasing third-quarter earnings.”
  • and
    • “Amwell posted a growing net loss in the third quarter as the telehealth firm notched another hefty goodwill impairment charge.
    • “The Boston-based company’s losses reached $137.1 million — a 94% increase from the same period in 2022 —  including $78.9 million in impairment charges linked to sustained decreases in its share price and market capitalization. Revenue declined 11% year over year to $61.9 million. 
    • “But a recent contract with the Department of Defense’s Health Agency that aims to digitize the military healthcare system “fortifies our path to profitability,” expanding Amwell’s reach within the public sector, CEO Ido Schoenberg said on a call with investors Wednesday.”
  • BioPharma Dive adds
    • “Novo Nordisk and Eli Lilly on Thursday reported strong sales growth for their rival GLP-1 metabolic disease drugs, setting up a 2024 showdown as the latter company’s latest product Mounjaro nears approval as a weight-loss rival to Novo’s Wegovy.
    • “Both companies cautioned about potential supply constraints, however. Wegovy still has limited availability at the starter dose, and Lilly CEO David Ricks said there is a need to increase manufacturing capacity “pretty dramatically from the current levels.
    • “Wegovy sales jumped nearly five-fold to 21.7 billion Danish krone, or about $3.1 billion, through the first nine months of this year, according to Novo. Sales of Ozempic, which is approved as a diabetes drug but used off-label in weight loss, were 65.7 billion krone, a 58% rise. * * *
    • “Lilly on Thursday revealed equally promising sales numbers for Mounjaro, which is so far approved only as a blood sugar-lowering agent for people with Type 2 diabetes. Sales of the dual-acting drug were $3 billion for the first nine months of 2023, which will be its first full year on the market. It is now Lilly’s second-biggest seller after another GLP-1 drug called Trulicity, sales of which have declined as Mounjaro’s have grown.
    • “A Food and Drug Administration decision on approving Mounjaro, known also as tirzepatide, in obesity should come by the end of 2023 * * *.”
  • The Wall Street Journal points out
    • “Both Lilly and Denmarks Novo Nordisk, which makes Ozempic and its sister drug Wegovy, are struggling to meet skyrocketing demand for their medications. There is no quick fix for that given the complexity of building out manufacturing capacity for the injections. Both companies are investing billions of dollars a year to try to catch up. * * *
    • “Keeping up with demand requires investments in factories that take years to build. Morgan Stanley analysts recently forecast the global anti-obesity market would be worth $77 billion by 2030. Mounjaro, Ozempic and Wegovy are injectables, which are complex to manufacture. Some oral medications currently in clinical trials, such as Lilly’s orforglipron, are smaller molecules, which are simpler to make. Supply constraints may only be truly remedied whenorals come to the market, the analysts said.”

Midweek update

David Ermer–Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “The House elected GOP Rep. Mike Johnson of Louisiana as speaker Wednesday, with the staunch conservative overcoming the divisions that had paralyzed the chamber after a band of hard-liners ousted Kevin McCarthy three weeks ago.
    • “The choice of Johnson, aligned with former President Donald Trump, came after House Republicans nominated and then dumped a series of leadership candidates, prompting some members to wonder whether any colleague could thread the needle in the deeply divided conference. With a speaker now in place, lawmakers can return to work, with many eager to pass aid for Israel and address a looming government-funding deadline next month.”
  • STAT News tells us,
    • “A Senate health panel on Wednesday voted to send President Biden’s nominee to lead the National Institutes of Health to the chamber’s floor, moving Monica Bertagnolli one step closer to taking the longtime vacant role of permanent director.
    • “The Senate HELP Committee advanced her nomination on a 15-6 vote, with many Republicans voting in support and only Chairman Bernie Sanders (I-Vt.) breaking with the Democratic caucus to vote against her. * * *
    • “Her nomination will now move to the Senate floor for a full vote, though it is unclear when that will be scheduled.”
  • The NIH National Cancer Institute shares its weekly research highlights.
  • The American Hospital Association News points out,
    • “Starting Oct. 25, consumers can preview their 2024 health coverage options at the federally facilitated Health Insurance Marketplace. Open enrollment for the 2024 marketplace runs Nov. 1 through Jan. 15, with coverage starting Jan. 1 for consumers who enroll by midnight on Dec. 15. The Centers for Medicare & Medicaid Services expects that 96% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies.”
  • FedWeek calls attention to the fact that the U.S. Office of Personnel Management’s Inspector General has released its annual report identifying top management challenges.

From the Federal Employee Benefits Open Season front, FedSmith provides a healthcare roadmap for federal retirees. Govexec provides its perspective on Open Season planning here.

From the public health front,

  • Politico reports,
    • “So far, 12 million people, or about 3.6 percent of the population, have gotten the shot in the five weeks since it hit pharmacy shelves — though reporting lags mean it’s likely a bit higher, Centers for Disease Control and Prevention Director Mandy Cohen said.
    • “More people, by far — 16 million — have gotten their annual flu vaccine, Cohen said, attributing the difference to long-held routines.”
  • From Fierce BioTech,
    • “As Americans flock to nearby orchards for festive bouts of autumn apple picking, Insulet is celebrating a particularly bountiful stateside Apple harvest itself.
    • “The diabetes device maker has earned FDA clearance for the iPhone version of an app allowing users to control their Omnipod 5 insulin pumps from their own smartphones. Meanwhile, the app has been available to Android owners since the pump’s full U.S. launch began a year ago.
    • “In Insulet’s Monday announcement about the Apple clearance, Eric Benjamin, the company’s chief product and customer experience officer, hailed the impending launch of the app as a “significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes.”
  • Morning Consult informs us,
    • “28% of U.S. adults said they are interested in taking prescription GLP-1 drugs like Ozempic, Mounjaro or Wegovy for weight loss, a share relatively consistent with August and April surveys. 
    • “Consumers who have heard “a lot” about the drugs, have weight-related health conditions or have higher incomes are most likely to be interested in taking the medications.
    • “The impacts of weight loss drugs on the health industry are clear, but other sectors, like food and retail, are likely to feel the effects of changing consumer preferences. Brands that create products and services to help support a more health-conscious consumer will be best-positioned to weather disruption from Ozempic or future weight loss drug innovations.”
  • Per MedTech Dive,
    • “Boston Scientific shared pivotal trial results on Wednesday that showed promising results for its drug-eluting balloon in treating patients with repeat blockages.
    • “The company’s Agent drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries at one year, according to data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference. Boston Scientific was the study sponsor.”
  • BioPharma Dive lets us know,
    • “Patients with Alzheimer’s disease may have another treatment option in the not-too-distant future, as newly released data appear to support a more convenient version of the closely watched medicine Leqembi.
    • “Developed by partners Eisai and Biogen, Leqembi is the only Alzheimer’s medicine of its type with a full approval from the Food and Drug Administration. It’s specifically for patients in the early stages of the disease, and is given as an hourlong, intravenous infusion once every two weeks.
    • “Eisai and Biogen have been testing whether a different form of Leqembi, an under-the-skin injection, can be as safe and effective as the already marketed version. On Wednesday, at a medical conference in Boston, researchers presented results from a study of nearly 400 participants that suggests the two forms are roughly comparable.”
  • The New York Times reports,
    • “In the year after the Supreme Court ended the constitutional right to abortion, something unexpected happened: The total number of legal abortions in the United States did not fall. Instead, it appeared to increase slightly, by about 0.2 percent, according to the first full-year count of abortions provided nationwide.
    • “This finding came despite the fact that 14 states banned all abortions, and seven imposed new limits on them. Even as those restrictions reduced the legal abortion rate to near zero in some states, there were large increases in places where abortions remained legal. Researchers said they were driven by the expansion of telemedicine for mail-order abortion pills, increased options and assistance for women who traveled, and a surge of publicity about ways to get abortions.”

From the U.S. healthcare business front,

  • Beckers Hospital Review notes, “Newsweek has released the top 600 U.S. hospitals ranked by state, sorted by a score that factors recommendations, patient experience, quality and patient-reported outcome measures.” The article identifies the top hospital on the Newsweek scale in each State and DC.   
  • Beckers Payer Issues tells us how payer accountable care organizations (ACOs) fared in 2022.
  • Beckers Hospital Review also interviews an executive from a Texas hospital about how the facility is planning to emerge from Chapter 11 bankruptcy.
  • Per Fierce Healthcare,
    • “An otherwise strong Q3 performance across HCA Healthcare’s businesses was marred by news that the for-profit’s recently integrated physician staffing joint venture will be bleeding tens of millions of dollars per quarter for the foreseeable future.”
  • and
    • “UnitedHealth Group is making a $5 million investment in Enable Ventures, a fund that aims to improve the lives of people with disabilities.
    • “The investment will back companies that can create better quality of life, offer resources to entrepreneurs with disabilities and provide support to people with disabilities who are unemployed or underemployed. Enable puts a focus on providing the technologies and tools necessary to upskill or reskill people with disabilities to help them enter or reenter the workforce, according to the announcement.
    • “Catherine Anderson, senior vice president of health equity strategy at UnitedHealth Group, told Fierce Healthcare in an interview that backing Enable aligns with the company’s broader investment strategy around health equity.”

Tuesday Tidbits

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

From Washington, DC

  • The Wall Street Journal reports,
    • “House Majority Whip Tom Emmer (R., Minn.) dropped his bid to serve as House speaker just hours after he was narrowly elected as the Republican nominee, as stiff resistance from hard-right conservatives reinforced by former President Donald Trump sank the party’s latest pick to run the chamber.
    • “His withdrawal put the Republicans back to square one for the fourth time, three weeks after hard-liners engineered the ouster of former Speaker Kevin McCarthy (R., Calif.). Republicans regrouped again late Tuesday to map out their next steps, assembling another slate of candidates and holding a fresh forum in the evening. A new vote was expected Tuesday evening.”
  • The Hill offers a potpourri of articles on this situation.
  • The American Hospital Association News informs us,
    • “The Centers for Disease Control and Prevention Oct. 23 released interim guidance for clinicians with limited access to the monoclonal antibody nirsevimab, recently approved to prevent respiratory syncytial virus in children aged 2 and under. The guidance calls for prioritizing 100 milligram doses of the treatment for infants under 6 months old and infants at high risk for severe disease due to underlying health conditions, among other recommendations.”
  • STAT News tells us,
    • “Infertility has a new definition in the U.S. — one that could make a big difference to would-be parents who are single or LGBTQ+.
    • “Last week, the American Society for Reproductive Medicine (ASRM) issued an expanded description of the condition, stating that infertility involves “the need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.”
  • It’s worth adding that for 2024, OPM adopted a broad definition of fertility coverage for the FEHBP to serve this purpose.
  • Also from STAT News,
    • “People eligible to use the only needle-free flu vaccine available in the United States may be able, next year, to give it to themselves or to eligible children at home.
    • “AstraZeneca, which makes the vaccine FluMist, announced Tuesday it has submitted to the Food and Drug Administration a supplemental biologics license application that would allow for self-administration of the vaccine by people ages 18 through 49, and would allow people 18 and older to give the vaccine to eligible children. FluMist is only licensed for use in children and adults from the age of 2 to 49 years old.”
    • “The application, which the FDA is considering, would not mean there would effectively be over-the-counter sales of FluMist, Lisa Glasser, head of AstraZeneca’s U.S. medical affairs for vaccines and immune therapies, told STAT in an interview. Rather, the vaccine, which must be stored at refrigerator temperatures, would be ordered and delivered under appropriate temperature controls, after consultation with a medical professional.
    • “Glasser said the program, if approved, would not replace the option of getting FluMist in a doctor’s office or at a pharmacy, but would be another alternative for busy families. “It is meant to enhance the ability to access influenza vaccination,” she said. “That’s the goal.”

From the public health and medical research front,

  • The NIH Directors blog points out,
    • When NIH launched The BRAIN Initiative® a decade ago, one of many ambitious goals was to develop innovative technologies for profiling single cells to create an open-access reference atlas cataloguing the human brain’s many parts. The ultimate goal wasn’t to produce a single, static reference map, but rather to capture a dynamic view of how the brain’s many cells of varied types are wired to work together in the healthy brain and how this picture may shift in those with neurological and mental health disorders.
    • So I’m now thrilled to report the publication of an impressive collection of work from hundreds of scientists in the BRAIN Initiative Cell Census Network (BICCN), detailed in more than 20 papers in Science, Science Advances, and Science Translational Medicine.1 Among many revelations, this unprecedented, international effort has characterized more than 3,000 human brain cell types. To put this into some perspective, consider that the human lung contains 61 cell types.2 The work has also begun to uncover normal variation in the brains of individual people, some of the features that distinguish various disease states, and distinctions among key parts of the human brain and those of our closely related primate cousins. * * *
    • All the data represented in this work has been made publicly accessible online  for further study. Meanwhile, the effort to build a more finely detailed picture of even more brain cell types and, with it, a more complete understanding of human brain circuitry and how it can go awry continues in the BRAIN Initiative Cell Atlas Network (BICAN). As impressive as this latest installment is—in our quest to understand the human brain, brain disorders, and their treatment—we have much to look forward to in the years ahead.”
  • Per STAT News,
    • “Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood.
    • “But now, after nearly a decade of development, the Apple Watch is being leveraged on an entirely new health frontier: Parkinson’s disease, the degenerative brain disorder that affects more than a half million Americans.
    • “While there is no cure for Parkinson’s and treatment options can be daunting, people with the disease can now turn to technology spawned by the Apple Watch to take an active role in their care much as continuous glucose monitors have helped people manage diabetes better. Over the past year, the Food and Drug Administration has cleared three Apple Watch apps from independent developers to track symptoms associated with Parkinson’s that can help inform treatment decisions for people and their doctors.”
  • and
    • “If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting, a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates (ADC)
    • “The conference opened to the news that Merck had signed one of the biggest licensing deals in industry history — worth up to $22 billion — to partner on three of the compounds from ADC specialist Daiichi Sankyo. GSK followed up with an ADC licensing announcement of its own (if a much smaller one). Multiple ADC studies were presented at the meeting’s top sessions. ADCs were, in short, the belle of the cancer research ball.
    • “The thing is, ADCs are actually quite an old approach.
    • “The industry’s been putting ADCs into the clinic for 20 years, and it’s only recently that we’ve really had a breakthrough here,” Susan Galbraith, who leads AstraZeneca’s cancer work, told STAT.
    • “ADCs are designed to deliver chemotherapy directly to tumors, possibly one day replacing the blunt-force toxic therapies that have been the backbone of cancer care for generations. The idea is that these finely crafted shipments can pack the punch of chemo while minimizing side effects. Experts are still scrutinizing the safety profiles of ADCs — they come with their own side effect concerns, and trials have included some patient deaths — but some studies are showing that patients can tolerate ADCs better than traditional chemo.”

From the U.S. healthcare business front,

  • Beckers Hospital Review provides us with a link to Healthgrades’s latest rankings of specialty hospitals.
  • Moreover, Beckers Hospital Review reports,
    • “Since launching in 2018, hospital-owned Civica Rx works with about a third of the nation’s hospitals and manufactures 80 drugs facing shortages, NBC affiliate KSL-TV reported Oct. 22. 
    • “Seven health systems formed the pharmaceutical company after struggling for years with recurring drug shortages. The first goal was to make 14 generics constantly in short supply for hospitals, and 19 systems were founding members. 
    • “Now, some governments and hundreds of hospitals are buying from Civica Rx. 
    • “Dan Liljenquist, the chief strategy officer for Salt Lake City-based Intermountain Health, volunteer board chair of Civica Rx and a former Utah senator, told KSL-TV Civica Rx plans to scale up operations at its Petersburg, Va.-based manufacturing plant.” 
  • and
    • “Pittsburgh-based UPMC said it has entered into an integration and affiliation agreement with Washington (Pa.) Health System, according to an Oct. 23 filing.
    • “The two signed a letter of intent in June regarding the partnership. Unions have criticized the move, saying it would harm both patients and workers.
    • “UPMC will appoint about one-third of the Washington Health board directors and the system will be renamed UPMC Washington, according to the filing.
    • “The proposed transaction still has to meet regulatory and closing conditions.”
  • Per Healthcare Dive,
    • “Centene raised its 2023 outlook on Tuesday after the health insurer handily beat Wall Street expectations for earnings and revenue in its third quarter, helped by lower medical costs.
    • “Centene reported a medical loss ratio — a marker of spending on patient care — of 87%, down from the year prior. On a call with investors Tuesday morning, executives chalked the lower medical spending up to significantly more members in Affordable Care Act marketplace plans, who generally require less expensive care than members in Medicaid and Medicare. Centene grew marketplace membership 76% year over year.
    • “The ongoing effect of Medicaid redeterminations — now almost halfway complete — on membership numbers and care acuity continues to track to Centene’s expectations, CEO Sarah London said on the call. Centene still expects to lose roughly two million members once redeterminations are complete.”
  • Per Fierce Healthcare,
    • “Teladoc’s third-quarter revenue grew 8% to reach $660 million, boosted by solid performance in its chronic condition management business and steady membership growth as the company now touts 90 million users.
    • “The telehealth giant, which has been in operation for 20 years, also narrowed its losses this past quarter to a net loss of $57 million, or 35 cents per share, compared to a net loss of $73.5 million, or 45 cents per share, for the third quarter of 2022.” 
  • and
    • “Elevance Health’s CarelonRx is the latest pharmacy benefit manager to put biosimilars for popular drug Humira on its formulary, the company said this week.
    • “Beginning Dec. 1, adalimumab-adbm will be added to each of its commercial formularies, according to a blog post from CarelonRx. Cyltezo will also be added to certain formularies, and both will be offered at parity with Humira.
    • “Humira has been the bestselling drug in the U.S. for a decade, and PBMs have long awaited biosimilar products to challenge the drug’s dominance in the market. Drugs that treat inflammatory conditions, like Humira, represent a growing piece of overall drug spend.
    • “Other key PBMs, including Express Scripts and Optum, have taken similar steps. CVS Health launched a new subsidiary, called Cordavis, earlier this year that aims to work alongside drugmakers to bring additional biosimilars to market, with the first product a Humira biosimilar in collaboration with Sandoz.”

Monday Roundup

David Ermer–Congress, COVID-19, Federal employment benefits, HSA, Medical / Rx research, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
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

David Ermer–Congress, Medical / Rx research, U.S. Healthcare–
Lincoln Memorial in the Fall

From Washington DC,

  • The Wall Street Journal adds.
    • “GOP lawmakers are heading into another week without a speaker will try to overcome deep divisions long enough to unify behind a new candidate, after colleagues soured on conservative firebrand Rep. Jim Jordan (R., Ohio) following a string of unsuccessful floor votes. 
    • “With the race now rebooted, nine Republican lawmakers are angling for the speaker job, jumping into the race before a Sunday deadline. 
    • “Rep. Tom Emmer (R., Minn.), who serves as the House’s majority whip, has announced a run. He already locked up an endorsement from former Speaker Kevin McCarthy (R., Calif.), who remains a popular and influential party member despite his sudden ejection from the speakership on Oct. 3. Other candidates include Kevin Hern of Oklahoma, who leads the conservative Republican Study Committee group, Byron Donalds of Florida, a political newcomer with ties to former President Donald Trump, and longtime lawmaker Pete Sessions of Texas. * * *
    • “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.”
  • The full House is scheduled to meet at 11 a.m. on Tuesday.

From the public health/research front,

  • The American Medical Association suggests seven steps that women should take to improve blood pressure control and identifies the top health tips that infectious disease doctors want their patients to know.
  • Fortune Well reports,
    • “It’s been a month since a Maryland man became the second person to receive a transplanted heart from a pig — and hospital video released Friday shows he’s working hard to recover.
    • “Lawrence Faucette was dying from heart failure and ineligible for a traditional heart transplant because of other health problems when doctors at the University of Maryland School of Medicine offered the highly experimental surgery.
    • “The Maryland team last year performed the world’s first transplant of a heart from a genetically altered pig into another dying man. David Bennett survived just two months before that heart failed, for reasons that aren’t completely clear, although signs of a pig virus later were found inside the organ. Lessons from that first experiment led to changes before this second try, including better virus testing.
    • “Attempts at animal-to-human organ transplants — called xenotransplants — have failed for decades, as people’s immune systems immediately destroyed the foreign tissue. Now scientists are trying again using pigs genetically modified to make their organs more humanlike.
    • “In Friday’s hospital video, Faucette’s doctors said the pig heart has shown no sign of rejection.”
  • Per FiercePharma,
    • “Last year, a first-of-its-kind head-to-head clinical trial between two PD-1 inhibitors went in GSK’s favor. Now, the British pharma has some new patient survival data to celebrate.
    • “Compared with Merck’s market-leading Keytruda, GSK’s Jemperli demonstrated a 25% lower risk of death in patients with newly diagnosed nonsquamous non-small cell lung cancer (NSCLC), according to new data unveiled today, Oct. 20, at the European Society for Medical Oncology (ESMO) 2023 Congress.
    • “The data come from an updated analysis of the phase 2 PERLA trial, which was the first global, head-to-head study of two PD-1 inhibitors.
    • “The number doesn’t bear statistical significance because the trial wasn’t designed to show superiority. It does, however, further prove that Jemperli behaves in a similar way as Keytruda does, Hesham Abdullah, M.D., who leads GSK’s oncology drug development, said in an interview with Fierce Pharma.”
  • MedTech Dive informs us,
    • “Shortages of medical devices and therapies are compromising patient care by delaying treatment and driving unsafe practices, according to a survey of healthcare professionals conducted by the patient safety nonprofit ECRI and the Institute for Safe Medication Practices.
    • “The survey found that supply shortages have caused surgical cases to be rescheduled, postponed or canceled and that a lack of endotracheal tubes and pulmonary artery catheters is on the cusp of impacting the ability to provide adequate clinical care.
    • “ECRI and the Institute for Safe Medication Practices used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages.”

In human resources news,

  • Per HR Dive,
    • “UPS will expand an ‘emergency child care initiative’ for U.S.-based front-line workers, the company announced Tuesday. The program, a partnership with Patch Caregiving, was piloted from August 2022 through January at a Northern California site. 
    • “According to UPS, 80% of eligible employees participated in the emergency daycare program, which helped the company avoid more than 120 unplanned absences. UPS also reported a significant reduction in employee turnover in the pilot group — from 31% to 4%.
    • “UPS will expand the program to additional shifts at the California pilot site and some Pennsylvania facilities this quarter. It will add additional facilities in 2024.”

Thursday Miscellany

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Mental health care, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Washington, DC,

  • The Wall Street Journal reports,
    • Republican speaker nominee Rep. Jim Jordan was weighing whether to embark on a third-floor vote after a plan to temporarily put caretaker speaker Rep. Patrick McHenry in charge of the House ran into sharp objections from conservatives.
    • “I am still running for speaker, and I plan to go to the floor and get the votes and win this race,” Jordan said initially after leaving a heated closed-door meeting of House Republicans. The Ohio conservative said the plan to elect a temporary speaker didn’t have the support of the conference.
    • In the evening, Jordan met in a House office with detractors. As some trickled out, there was no sign he had managed to change their minds, and Jordan wouldn’t say after the meeting whether he still intended to hold another floor vote. 
  • The New York Times adds, “Mr. Jordan said he would push for another vote to become speaker, scheduled for Friday at 10 a.m., even though he was bleeding support and calls were increasing for him to step aside.”
  • The Society for Human Resource Management informs us,
    • “The U.S. Supreme Court has agreed to hear two cases that will impact the power of federal agencies to implement regulations on employers.
    • “On Oct. 13, the court decided to hear Relentless v. Department of Commerce, in which the owners of three fishing companies in Rhode Island and Massachusetts sued to challenge the federal government’s authority to require them to partially pay for federal monitors on their boats. The justices willconsider that case in tandem with a similar case, Loper Bright Enterprises v. Raimondo, which involves the same requirement for fishing companies in New Jersey.
    • “In both cases, the justices will decide whether to overturn the long-standing Chevron precedent, which holds that when Congress wrote a statute without a clear meaning, courts should defer to the federal agency applying the law, unless its directives were unreasonable. Federal departments and agencies that enforce employment laws could be impacted.”
  • In yesterday’s post, the FEHBlog called attention to AHIP’s public comments on the proposed rule, making changes to the current mental health parity rules. AHIP asked the regulators to try again. Per Fierce Healthcare,
    • “The Blue Cross Blue Shield Association (BCBSA) echoed AHIP in its comments, arguing that additional clarity around the changes is necessary. The organization said it could lead patients to care that is not recommended, worsening outcomes.
    • “We share the administration’s goal of expanding access to affordable mental health support, but we’re concerned it could become harder—not easier—for patients to get the care they need,” said David Merritt, BCBSA’s senior vice president of policy and advocacy, in a statement.
    • “This rule could push us in the wrong direction by forcing health plans to remove important protections that ensure patients are receiving safe, medically necessary, effective care,” Merritt added. “We’ll continue to work with our partners, the administration and Congress to improve both access and quality for Americans.”
    • “The Alliance for Community Health Plans said the updates create “an entirely new regulatory schema” that would actually impede insurers looking to address mental health parity.
    • “The ERISA Industry Committee, or ERIC, said many of the proposals “reflect an overreach of agency authority under the statute” and that they would be burdensome for employer-sponsored health plans. The changes, ERIC said, could drive up costs for families and force significant changes to benefit designs.
    • “Unfortunately, the proposed regulations are so unworkable, it is unclear how compliance could ever be achieved while continuing to offer these important benefits,” said James Gelfand, CEO of ERIC, in a statement. “The Departments’ proposals are written in a way that sets plans up to fail.”
  • The FEHBlog agrees.
  • Reuters tells us,
    • “The U.S. health regulator [the Food and Drug Administration] has approved Hyloris Pharmaceuticals’ drug for post-operative pain, the Belgium-based company said on Wednesday, adding that it expects to launch the non-opioid treatment in the United States by early next year.
    • “The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally.
    • “Maxigesic IV, a combination of paracetamol with ibuprofen solution for infusion, helps reduce pain and inflammation without the risk of opioid addiction that resulted in more than half a million deaths in the U.S. during 1999 to 2020.”

From the public health front,

  • HHS’s Agency for Healthcare Research and Quality posted for public comment an Effective Health Programs abstract on caring for Long Covid. The comment period ends on November 17, 2023.
  • Healio points out,
    • “Data show CMS’ Million Hearts CVD Risk Reduction Model, which provided payments for CVD risk assessment and reduction, reduced incidence of first-time MIs and strokes over 5 years without significant changes in Medicare spending.
    • “The results support clinical guidelines for CVD preventive care,” G. Greg Peterson, PhD, MPA, a principal researcher with Mathmatica, told Healio. “Current guidelines in the U.S., similar to those in other countries, recommend that health care practitioners calculate CVD risk scores and use the scores to engage patients in discussions about CVD prevention. Although previous studies of CVD risk scoring interventions have shown improvement in CVD risk factor control, this is the first study of a CVD risk score-focused intervention to demonstrate declines in CVD events.”
  • Health Day lets us know,
    • “Fluctuating blood pressure can be a harbinger for both dementia and heart disease, a new study finds.
    • “Ups and downs within 24 hours or even over several days or weeks were linked with impaired thinking, researchers from Australia reported.
    • “Higher variations in systolic blood pressure, the top number, were linked with stiffening of the arteries, which is associated with heart disease.
    • “Clinical treatments focus on hypertension while ignoring the variability of blood pressure,” said lead author Daria Gutteridge, a PhD candidate at the University of South Australia’s Cognitive Aging and Impairment Neuroscience Laboratory.”
  • The National Institutes of Health announced,
    • “A research team funded by the National Institutes of Health has developed a smartphone app that can track and analyze a person’s ability to move from one place to another, known as locomotion and other types of movements. Human motion analysis is used to evaluate patients with movement difficulties, to help clinicians plan surgery, and to assess the results of treatment procedures. The research team believes that using the app costs about 1% of conventional motion analysis techniques and works 25 times faster. The study appears in PLOS Computational Biology.
    • “Researchers tested their app, called OpenCap, with 100 participants. Using two or more smartphones, the app recorded sufficient quality videos to allow for web-based, artificial intelligence analysis of muscle activations, joint loads and joint movements. Data collection took 10 hours for the 100 participants, and computation of results took 31 hours. Traditionally, locomotion analysis requires fixed lab space and more than $150,000 worth of equipment, including eight or more specialized cameras to capture three-dimensional images. The captured data also takes several days to analyze by a trained expert.
    • “While current technology is too expensive for routine clinical use, according to the investigators, the app could potentially be used to help screen for disease risk, inform rehabilitation decisions, and track improvements in motion following treatment.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • CVS Health is pulling some of the most common decongestants from its shelves and will no longer sell them, after advisers to U.S. health regulators recently determined that an ingredient doesn’t work.
    • The products contain [as the only active ingredient] oral phenylephrine, an almost-century-old ingredient in versions of decongestants and over-the-counter pills, syrups and liquids to clear up congested noses.
    • An advisory panel to the Food and Drug Administration last month declared that the ingredient was ineffective when taken orally. The FDA had said in its own analysis that the oral phenylephrine formulations are safe but ineffective at standard or even higher doses.
    • The FDA hasn’t made a decision yet nor asked manufacturers or retailers to remove products from store shelves. CVS is removing phenylephrine products voluntarily.
  • Beckers Hospital Review informs us,
    • “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. 
    • “Rite Aid has more than 2,000 stores in 17 states. Of the 154 planned closures, about 40 are Pennsylvania locations. Many stores in California and New York will also close, and additional store closings may be forthcoming as Rite Aid looks to shed about $4 billion in debt. 
    • “The Philadelphia-based company previously said it secured $3.45 billion from lenders to fund operations through the bankruptcy restructuring, with McKesson Corp. as the largest creditor. Alongside the bankruptcy filing, Rite Aid announced Jeffrey Stein as its new CEO and chief restructuring officer.”