Midweek Update

CDC

Midweek Update

David Ermer–CDC, Congress, COVID-19, FDA, Medicare, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Senate Finance Committee announced,
    • Senate Finance Committee Chairman Ron Wyden, D-Ore., will convene a committee hearing on Tuesday, December 5, 2023 titled “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective.” The hearing will take place at 10:00 a.m. in Room 215 of the Dirksen Senate Office Building.
  • The American Hospital Association News notes,
    • “The House Energy and Commerce Subcommittee on Health Nov. 29 held a hearing  to explore how medical devices and hospitals are using artificial intelligence and what Congress should consider as AI in health care evolves.”
  • BioPharma Dive reports,
    • “The Food and Drug Administration’s top scientist Namandjé Bumpus will assume the role of principal deputy commissioner when longtime agency leader Janet Woodcock retires from that role in early 2024, according to an announcement Thursday.
    • “Among Bumpus’ priorities when she assumes the role will be “creating a new model” for the FDA’s Office of Regulatory Affairs, the branch that conducts inspections, monitors drug imports, and issues recalls, market withdrawals and safety alerts, Commissioner Robert Califf said in a memo to agency staff.”
  • Sequoia reminds us,
    • “Beginning in 2024, group health plans and carriers will be required to include all covered items and services in their self-service internet-based price comparison tool, as required under the Transparency in Coverage (TIC) Final Rules.
    • “As background, plans must provide participants and beneficiaries with out-of-pocket cost estimates via a user-friendly online self-service tool (and by paper upon request). The intent of this requirement is to provide individuals with real-time cost-sharing information to support making informed health care decisions. Implemented in two phases, the first phase of the price comparison tool required the first 500 items and services (as defined by the DOL) to be published in the tool effective for plan years beginning on or after January 1, 2023, and the second phase will require all other services covered by the plan to be included in the tool effective for plan years beginning on or after January 1, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control announced,
    • “CDC’s National Center for Health Statistics released two reports today examining provisional mortality data from 2022. While analysis shows the number and rate of suicides increased for the second year in a row from, overall life expectancy at birth increased by just over a year. This increase regains some of the 2.4 years of life expectancy lost between 2019 and 2021.
    • “The findings are featured in two new reports, “Provisional Life Expectancy Estimates for 2022” and “Provisional Estimates of Suicide by Demographic Characteristics: United States, 2022. * * *
    • “The increase of 1.1 years in life expectancy from 2021 to 2022 primarily resulted from decreases in mortality due to COVID-19, heart disease, unintentional injuries, cancer, and homicide. Declines in COVID-19 mortality accounted for approximately 84% of the increase in life expectancy. * * *
    • “The percentage increase in the number of suicides was greater for females (4%) than males (2%), but the provisional 2022 suicide number for males (39,255) was nearly four times that of females (10,194).”
  • Health Day points out,
    • “The prevalence of a highly mutated COVID variant has tripled in the past two weeks, new government data shows.
    • “Now, nearly 1 in 10 new COVID cases are fueled by the BA.2.86 variant, the U.S. Centers for Disease Control and Prevention reported Monday.
    • “The variant is spreading the fastest in the Northeast: Just over 13% of cases in the New York and New Jersey region are blamed on BA.2.86. * * *
    • “So far, preliminary data on the variant suggests it does not trigger more severe illness than previous variants, the WHO said in a recent risk evaluation, but the international agency still noted a recent and “substantial rise” in BA.2.86 cases.
    • “The CDC also noted that BA.2.86 variant poses a “low” public health risk.”
  • and
    • “Personal trainers can help people increase their strength and their fitness.
    • “Could a “brain coach” be just as useful in preventing Alzheimer’s’ disease?
    • “A new study suggests that personalized health and lifestyle changes can delay or even prevent memory loss for older adults at high risk of Alzheimer’s or dementia.
    • “People who received personal coaching experienced a 74% boost in their thinking and memory tests compared with those who didn’t receive such attention.
    • “This is the first personalized intervention, focusing on multiple areas of cognition, in which risk factor targets are based on a participant’s risk profile, preferences and priorities, which we think may be more effective than a one-size-fits-all approach,” said co-lead researcher Dr. Kristine Yaffe, vice chair of research in psychiatry at the University of California, San Francisco (UCSF).”
  • Healio informs us,
    • “One in four adults relied solely on medications to manage chronic pain, highlighting an opportunity to increase use of nonpharmacologic therapies, particularly in men, older adults and those with public insurance, according to researchers.
    • “Findings from this study contribute important information about use of over-the-counter pain relievers, prescriptions nonopioids and exercise, which were found to be some of the most common pain management therapies used by adults with chronic pain,” Stephanie Michaela Rikard, PhD, a health scientist at the CDC, told Healio.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cigna and Humana are in talks for a combination that would create a new powerhouse in the health insurance industry.
    • “The companies are discussing a stock and cash deal that could be finalized by the end of the year, assuming the talks don’t fall apart, according to people familiar with the matter.”
  • and
    • “A law designed to protect patients from surprise medical bills is contributing to the financial distress of some medical-service providers, which say lengthy billing disputes and payment delays with insurers are hurting their ability to stay afloat. 
    • “The No Surprises Act, which took effect last year, aims to protect patients from surprise medical bills from out-of-network healthcare providers when there are disagreements over reimbursements between insurers and providers. Previously, providers often billed patients to make up for the amounts insurers were unwilling to pay. 
    • “Numerous healthcare businesses, some owned by private equity, said the legislation is contributing to delays and reductions in payments by insurance companies, hurting their cash flows and earnings. A handful of major healthcare-service providers already have filed for chapter 11 protection this year, specifically naming the law as a major reason for their bankruptcies. These include physician-staffing companies Envision Healthcare and American Physician Partners as well as helicopter-ambulance operator Air Methods.”
  • and
    • “There are five tech companies valued at over $1 trillion. In healthcare, the closest contender is  Eli Lilly. 
    • .”This year it became the first big pharmaceutical to surpass a market capitalization of $500 billion thanks to the popularity of its obesity and diabetes medications and, to a lesser extent, its experimental Alzheimer’s drug. But hanging over Lilly and rival  Novo Nordisk is a reality that puts the brakes on big pharma’s ascent: the patent cliff.
    • “There are several reasons why there isn’t a big pharma company in the trillion-dollar club, but the boom-and-bust nature of drug development is high on the list. Unlike Apple, which hypothetically can make huge margins off the iPhone for perpetuity, U.S. drug companies have a limited period from which to profit from their innovation. As their patents expire and generic competitors enter the market, sales plunge. Pharma executives, overly focused on short-term growth, don’t often prepare their companies for that.”
  • FEHBlog notes on the Journal articles,
    • Cigna and Humana are undoubtedly aware of the firebreathing nature of anti-trust enforcers in the federal government. Cigna is focused on the commercial market while Humana currently is pulling out of that market to focus on government business. Time will tell.
    • Out-of-network doctors and air ambulance companies flying the pirate flag can avoid No Surprises Act problems by joining health plan networks.
    • Lilly’s recent growth has been impressive.
  • Reuters tells us,
    • “UnitedHealth Group on Tuesday forecast 2024 profit broadly in line with Wall Street expectations, indicating that medical costs are likely to remain elevated for the health insurance giant.
    • “The healthcare sector has this year seen a recovery in demand, especially among older patients who started returning to doctors’ clinics and hospitals for procedures they had delayed during the COVID-19 pandemic.”
  • Healthcare Dive adds,
    • “Healthcare insurers could get a slight respite from rising medical costs next year. Global costs are expected to rise 9.9% year over year in 2024, down from a 10.7% increase in 2023, according to a new survey from consultancy WTW released on Tuesday.
    • “However, that decline might not last long. Nearly three-fifths of insurers surveyed anticipate higher medical cost growth over the next three years as new medical technologies, overuse of care and members’ poor health habits drive increased spend.
    • “Many insurers told WTW they are leaning on deductibles, contracted provider networks and telehealth options to manage costs. Others are excluding coverage for healthcare such as fertility treatments or gender re-affirming care.”
  • Beckers Hospital CFO Report identifies the states with the most rural hospital closures.
    • “Since 2005, 104 rural hospitals have closed and more than 600 additional rural hospitals — 30% of all rural hospitals in the U.S. — are at risk of closing in the near future, according to the Center for Healthcare Quality and Payment Reform.”
  • Beckers Hospital Review calls attention to this development,
    • “Mayo Clinic’s board of trustees has given the green light to an initiative dubbed “Bold. Forward. Unbound.,” which involves a $5 billion redesign of Mayo Clinic’s downtown Rochester, Minn., campus. 
    • “The redesign will introduce new facilities that incorporate innovative care approaches and digital technologies, according to a Nov. 28 news release from Mayo, with a pivotal element of these being specialized “neighborhoods.” According to the health system, the neighborhood concept will offer patients a centralized location for all required services related to their specific condition, eliminating the need for navigating between different departments.”
  • Per Fierce Healthcare,
    • “Accountable care organizations do not positively influence treatment and outcomes for chronic mental health conditions for Medicare patients, according to a study in Health Affairs.
    • “For patients newly enrolled in ACOs, they saw no improvements in their depression and anxiety symptoms after one year. These patients were also 24% less likely to have their depression or anxiety treated than patients unenrolled in ACOs, and 9.8% less likely to have an evaluation and management visit for depression or anxiety with a primary care clinician.
    • “Since mental health conditions in Medicare patients are often underdiagnosed and undertreated, some have suspected that mental health illnesses are ideal conditions for ACOs to handle, but the study found that there were no significant differences in any other measures of mental health treatment.”
  • Beckers Hospital Review also names the winners of Forbes 30 under 30 in healthcare for 2024.


 

Thanksgiving Weekend Update

David Ermer–CDC, Congress, COVID-19, Medicare, OPM, U.S. Healthcare–

We are halfway through the Federal Employee Benefits Open Season, which will end on December 11.

The Senate and the House of Representatives will be engaged in Committee business and floor voting this week.

Axios brings us a dental coverage update for Affordable Care Act plans and Medicare. Of note, Axios tells us that “earlier this month, the Biden administration expanded all Medicare beneficiaries’ access to dental services when they’re necessary for other medical care, like cancer treatment.”

From the public health front,

  • Axios reports
    • “The big picture: In the two years since Omicron emerged, it has continued to rank as the predominant strain in the U.S., and its subvariants are now driving most of the country’s coronavirus infections.
    • “State of play: COVID-19 is circulating in every country and remains a threat, Maria Van Kerkhove, the WHO’s technical lead on COVID-19, said in an update Tuesday.
      • “Infection from the variants now in circulation can cause anything from asymptomatic infection to severe disease, pneumonia and death, she explained.”Infection from the variants now in circulation can cause anything from asymptomatic infection to severe disease, pneumonia and death, she explained.
      • “Luckily, she added, most people are experiencing less severe symptoms because they have population-level immunity from vaccination, prior infection, or both.
    • “Zoom in: Case rates are not as high as this summer, but experts expect they may rise during the winter as they have the past three years, given colder weather that drives people indoors and holiday gatherings.”
  • The Wall Street Journal adds,
    • “Flu and RSV killed thousands of people on their own during typical winters before the pandemic. Covid isn’t killing people as it once did, but it remains the deadliest of the three—in part because it is more active year-round. 
    • “The Centers for Disease Control and Prevention predicts hospitalizations this year will be about the same as last year: well above pre-pandemic levels. Even a milder season with the three viruses circulating together would likely mean more hospitalizations than a severe season of just flu and RSV, said Jason Asher, who directs a CDC forecasting department.
    • “More illness means more disruptions to life and work. The flu alone is responsible for billions of dollars in medical and economic costs and millions of lost workdays. Covid has added to worker absences in recent winters.  * * *
    • “There’s one more virus out there for you to get,” said Justin Lessler, an infectious disease epidemiologist at the University of North Carolina. “Your risk of getting sick has probably gone up.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “About half of all people are in hospice at the end of their lives, but more than 25 percent of hospice patients enroll in the final week, according to 2021 data from the Medicare Payment Advisory Commission, which advises Congress on Medicare issues.
    • “Others among the 1.7 million Medicare patients who used hospice that year availed themselves of its services for much longer. That is reflected in data that reveal the dual nature of hospice: The median stay is only 17 days, meaning half of patients were in hospice less than 17 days and half longer than that. But the average is 92 days, which shows that some patients were in hospice for many months.”
  • The Wall Street Journal points out,
    • A healthcare hiring boom is helping offset weaker job growth in other areas of the softening U.S. economy, boosting its chances of skirting a recession.
    • The industry could serve as a strong job generator for years to come as an aging population and Covid-19 fuel widespread worker shortages and greater needs for healthcare services. 
    • Healthcare providers—including hospitals, clinics, pharmacies and doctors’ offices—accounted for 30% of U.S. job gains in the six months through October, though less than 11% of the country’s total employment, Labor Department figures show. 
    • “As behavior returns to normal—as kids go back to germ-factory indoor play spaces and daycare centers, and as people schedule elective procedures and catch up on routine scans delayed during the height of the pandemic—providers are having to staff up to keep up with demand,” said Julia Pollak, chief economist at Ziprecruiter.”

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Generative AI, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC (note the FEHBlog is back in Texas after a productive week in DC)

  • The Society for Human Resource Management tells us,
    • “The National Labor Relations Board (NLRB) announced it will extend the effective date of its joint employer rule to Feb. 26, 2024, to facilitate resolution of legal challenges to the rule.
    • “The NLRB released the final rule on Oct. 26 with an implementation date of Dec. 26. The rule was published in the Federal Register on Oct. 27.
    • “U.S. Sen. Bill Cassidy, R-La., sent a letter informing the NLRB that it was out of compliance with the Congressional Review Act’s 60-day threshold rule, which mandates that the implementation of all major federal rules must be delayed 60 days from when they are received by Congress.
  • The Internal Revenue Service posted for public comment a draft version of the 2024 Employers’ Tax Guide to Fringe Benefits.

From the public health and medical research front,

  • The Associate Press reports,
    • “The U.S. flu season is underway, with at least seven states reporting high levels of illnesses and cases rising in other parts of the country, health officials say.
    • “The Centers for Disease Control and Prevention posted new flu data on Friday, showing very high activity last week in Louisiana, and high activity in Alabama, Florida, Georgia, Mississippi, New Mexico and South Carolina. It was also high in the District of Columbia and Puerto Rico, the U.S. territory where health officials declared an influenza epidemic earlier this month. * * *
    • “Traditionally, the winter flu season ramps up in December or January. But it took off in October last year, and is making a November entrance this year.”
  • STAT News offers its observations on this development.
    • “The early signals from influenza suggest the virus is settling back into the seasonal pattern it followed — to the degree the always mercurial bug follows any pattern — before the pandemic, said Alicia Budd, team lead for domestic flu surveillance at the Centers for Disease Control and Prevention. “All I can say is at this point we are at a pretty typical point in flu activity,” she told STAT.
    • “Overall, the signs to date appear to portend a winter more like what we knew before the arrival of Covid, said Megan Culler Freeman, an assistant professor of pediatrics specializing in infectious diseases at the University of Pittsburgh.
    • “Last year as early as August, children’s hospitals across the country were full to the gills … because there were so many children with respiratory distress,” Freeman said. “And I would say that this season is starting to feel a lot more normal. Only now, as we’re getting into November — even towards mid- to late- November — we’re starting to see more of our winter volume starting to begin. * * *
    • “The scientific consensus is still out about whether Covid will be a seasonal virus, transmitting primarily during cold-and-flu season. Many experts think it is heading that way, but hasn’t yet settled into that pattern.”
  • The American Medical Association explains what doctors wish their patients knew about diabetes 2. Check it out.
  • KFF informs us,
    • “Research suggests that the Novavax [Covid] vaccine is about as safe and effective as the mRNA shots. Its main disadvantage is arriving late to the scene. Vaccine uptake has plummeted since the first shots became widely available in 2021. Nearly 70% of people got the primary vaccines, compared with fewer than 20% opting for the mRNA covid boosters released last year. Numbers have dwindled further: As of Oct. 17, only 5% of people in the United States had gotten the latest covid vaccines, according to the Department of Health and Human Services.
    • “Daniel Park, an epidemiologist at George Washington University, said low rates might improve if people who felt lousy after their last mRNA shots gave Novavax a try. It protects against severe illness, but researchers struggle to specify just how effective this and other vaccines are, at this point, because studies have gotten tricky to conduct: New coronavirus variants continuously emerge, and people have fluctuating levels of immunity from previous vaccines and infections.
    • “Still, a recent study in Italy suggests that Novavax is comparable to mRNA vaccines. It remained more than 50% effective at preventing symptomatic covid four months after vaccination. Some data suggests that mixing and matching different types of vaccines confers stronger protection — although other studies have found no benefit. 
    • “Given all this, Park held out for the Novavax vaccine on account of its potentially milder side effects. “Between a demanding full-time job and two young kids at home, I wanted to stay operational,” he said. His arm was sore, but he didn’t have the 24-hour malaise accompanying his last mRNA shot.”

From the U.S. healthcare business front,

  • MedCity News notes,
    • “Eli Lilly’s cardiometabolic drug portfolio is expanding with newly approved therapies. To meet demand for those therapies and additional products to come, the company is building a new $2.5 billion manufacturing site in Germany.
    • “Construction on the new plant is on track to begin next year. Lilly expects the site will start operations in 2027, becoming its sixth manufacturing site in Europe. The company said it has invested more than $11 billion in its global manufacturing capabilities in the past three years to support the production of medicines across its portfolio.
    • “Some of Lilly’s capital investments have been closer to the Indianapolis-based drugmaker’s home. Last year, the company committed more than $2 billion to two new facilities in Lebanon, Indiana for the manufacturing of existing products and future ones, the company said in its annual report. Lilly also invested more than $1 billion in a new facility in Concord, North Carolina, for the manufacturing of injectable products and devices. Earlier this year, Lilly pledged to spend an additional $450 million to expand capacity at a site in Research Triangle Park that also makes injectable products, including new blockbuster medicine Mounjaro.”
  • Healthcare Dive points out,
    • “AstraZeneca’s new health-tech business, Evinova, launched Monday, with several big-name partnerships already in place and a goal to “better meet the needs of healthcare professionals, regulators and patients.”
    • “Evinova’s main focus will be helping to optimize their clinical trials for biotechnology companies, pharmaceutical firms and CROs, or contract research organizations, in an effort to reduce the time and costs associated with developing new medicines.
    • “Two CROs, Parexel and Fortrea, have agreed to offer Evinova’s digital health solutions to their customers. Evinova is also collaborating with Accenture and Amazon Web Services to “accelerate industry adoption and sustain and expand the global reach of its digital products.”
  • Per Fierce Healthcare,
    • “The financial outlook for major health plans is stable in the face of notable potential headwinds heading into the end of the year, according to a new report from Moody’s Investors Service.
    • “The Moody’s analysis said earnings in the third quarter were on par with reports from the second quarter and that the industry’s stability is in line with expectations. However, the researchers said they were expecting payers to face different challenges as 2023 got underway.
    • “A notable trend that emerged in the second quarter was increased utilization in Medicare Advantage (MA), which peaked in the second quarter thanks to a boost in outpatient care. While the trend did stabilize in the third quarter, “it did not get better,” the Moody’s analysts wrote.
    • “Centene was the lone exception, and it reported a lower medical loss ratio for MA in the third quarter of 2023 compared to the prior-year quarter, according to the report.”
  • and
    • “As the industry continues to debate the promise and risks of artificial intelligence in healthcare, patients are bullish on the potential for generative AI to improve access and even lower healthcare costs.
    • “More than half (53%) of U.S. consumers believe generative AI could improve access issues and shorten wait times for medical care, according to a survey by Deloitte’s Center for Health Solutions. A little less than half of consumers (46%) say it has the potential to make healthcare more affordable.”

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, OPM, SDOH, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • President Biden on Friday named W. Kimryn Rathmell to be the next director of the National Cancer Institute, where the prominent researcher will help oversee several White House-backed initiatives intended to reduce cancer deaths and accelerate clinical breakthroughs.
    • Rathmell, an expert in kidney cancer, is the chair of medicine at Vanderbilt University Medical Center in Nashville. The Stanford University-trained physician and scientist has been a member of the National Cancer Institute’s board of scientific advisers since 2018, providing guidance to the institute’s leaders on its scientific research and operations. Rathmell’s new role as head of the cancer institute, which the White House said would begin in December, does not require Senate confirmation.
  • Federal News Network tells us,
    • “The Office of Personnel Management faces a tight deadline to set up a new health insurance marketplace for Postal Service employees and retirees to enroll in new plans, starting next year.
    • “Now OPM is addressing watchdog concerns about whether the IT infrastructure supporting this new USPS marketplace is following federal cybersecurity requirements.
    • “OPM’s Office of Inspector General, in a flash audit released Friday, raised concerns about the cybersecurity steps OPM took before launching the IT systems that will run the Postal Service Health Benefits (PSHB) Program.”
  • Govexec tells us,
    • The Office of Personnel Management this week proposed new regulations delegating its authority to waive the caps on recruitment and relocation incentive payments to federal employees and job candidates to the agencies themselves, a move the federal government’s HR agency says will ease administrative burdens and accelerate the hiring process. * * *
    • “Under the new process, each agency would be required to designate an official who would be tasked with reviewing and adjudicating waiver requests. Additionally, the new regulations would eliminate the minimum service period required to receive an incentive payment. Currently set at six months, OPM argued that removal of the minimum time period would allow short-term, yet still difficult to fill positions such as paid internships to become eligible for recruitment and relocation incentives.
    • “Retention incentive payments would not change under the regulatory proposal, as OPM reported that such changes would require the passage of legislation by Congress.”
  • The Government Accountability Office issued a report on the composition of the federal workforce.
    • “The federal government aims to hire and promote a workforce that reflects the diversity of the U.S. population.
    • “We looked at a decade of federal employment trends. For example, from 2011-2021 there were minor changes in the representation of historically disadvantaged racial groups—like Black or African American and Asians—in the federal workforce. But several of these groups made gains in senior executive service positions.
    • “The percentage of Hispanic federal workers also increased. But in FY 2021, Hispanic individuals made up 10% of the federal workforce, even though they represented 18% of the civilian labor force.”
  • Reuters reports,
    • “The U.S. Centers for Disease Control and Prevention said on Thursday it has expedited the release of more than 77,000 additional doses of Sanofi (SASY.PA) and AstraZeneca’s (AZN.L) respiratory syncytial virus (RSV) drug Beyfortus.
    • “The additional doses, which the CDC said will be distributed immediately to physicians and hospitals, will help improve the availability of the drug at a time when a surge in cases of the disease is outpacing supply.
    • “Beyfortus was approved earlier this year to prevent the disease in infants and toddlers.
    • “CDC said the agency, along with the U.S. Food and Drug Administration, will continue to be in close contact with the manufacturers to ensure availability of additional doses through the end of this year and early 2024 to meet the demand.”

In FEHB News, Federal News Network offers a lengthy and informative exchange with Kevin Moss from Consumer Checkbook.

From the public health and medical research front,

  • STAT News points out,
    • “Flu activity in many parts of the United States is starting to rise more rapidly, signaling that flu season is on the horizon, the Centers for Disease Control and Prevention reported Friday.
    • “With Americans set to travel for Thanksgiving gatherings next week, people who’ve been waiting to get a flu shot should think about acting now, Alicia Budd, the CDC’s team lead for domestic flu surveillance, told STAT.
    • “Really what we’re seeing is a more sharp increase in activity, week over week, and we know from experience when that happens often times we are entering into that period of even more increased activity,” Budd said. “It’s a great time for people to get vaccinated, if they’ve been holding off.”
  • ABC News states,
    • An estimated 36 million adults in the United States have received the updated COVID-19 vaccine as of Monday according to new data from the federal government.  Additionally, about 3.5 million children have also gotten the updated shot, according to the survey, which is a sample size of the U.S. population, from the Centers for Disease Control and Prevention. This is roughly equal to the number of Americans who had received the bivalent booster — which was targeted against different COVID variants — by this time last year.
  • The Wall Street Journal reports,
    • “The Food and Drug Administration said it is screening cinnamon shipments from several countries as part of its investigation of illnesses potentially linked to pouches of cinnamon-flavored applesauce.
    • “The federal agency said this week it believes the cinnamon used in these products could be the source of lead contamination. There have been 34 reports of lead-related illnesses potentially tied to the recalled products. 
    • “The FDA, which has been investigating the lead illnesses since October, said they are potentially linked to contaminated children’s fruit puree and applesauce pouches. WanaBana,  Weis Markets and Schnucks brands have recalled cinnamon-flavored fruit puree and applesauce pouches.”
  • CNN reports,
    • “The rate of premature birth in the United States remains high, especially in the southern region of the country, according to the infant and maternal health nonprofit March of Dimes.
    • “The group’s annual “report card” on US maternal and infant health, released Thursday, says that the nation’s preterm birth rate – the rate of babies born before 37 weeks gestation – was 10.4% in 2022, down only 1% from 2021’s rate, which was the highest in more than a decade.
    • “We went from 10.5% to 10.4%. It’s flat,” said Dr. Elizabeth Cherot, president and chief executive officer of March of Dimes. “A slight change is just not big enough in that direction.”
  • Per NBC News,
    • The rate of child and teen cancer deaths in the U.S. fell 24% from 2001 to 2021, according to a CDC report released Thursday. The report looked at death rates, for Black, Hispanic and non-Hispanic whit youths up to 19 years old. These groups comprised 92% of all youth cancer deaths in 2021, the report noted.
  • Per STAT News, while Wegovy and Zepbound ride high, interest in weight loss drugs that preserve muscle is surging.
    • [B]iotech startups are hoping to use those [earlier Johns Hopkins] findings to create what they believe will be better weight loss medications. In the last several months, multiple companies have disclosed they are testing drugs that preserve or grow muscle while reducing fat, as shown in the updated STAT Obesity Drug Tracker. They hope that their drugs, possibly when used in conjunction with existing obesity treatments, will result in healthier weight loss.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • Rochester, Minnesota-based Mayo Clinic reported increased year-over-year operating revenue and income in its third-quarter earnings, on higher outpatient visits and surgical cases.
    • The nonprofit posted $4.5 billion in operating revenue, up 8.2% year over year, and $302 million in operating income. Operating expenses rose 4.8% year over year, totaling nearly $4.2 billion.
    • The earnings mark the third quarter Mayo has posted net income after the operator struggled last year. The health system reported profits last year that were half its 2021 returns, after contract labor expenses increased 37% year over year. 
  • and
    • For-profit operator Tenet Healthcare has agreed to sell three of its hospitals in South Carolina for about $2.4 billion in cash to Winston-Salem, North Carolina-based Novant Health. 
    • Proceeds from the deal, which is expected to close in the first quarter in 2024, will primarily go toward paying debt, Tenet said in a news release. 
    • Under the agreement, Dallas-based Tenet’s financial services subsidiary Conifer Health Solutions will also provide revenue cycle management for the hospitals and their related operations under an expanded 15-year contract. 
  • and
    • CommonSpirit Health reported a $441 million operating loss in the first quarter of the 2024 fiscal year on increased expenses.
    • The system expects a California assistance fund — due to be approved later this fall — to offset its operational losses slightly. However, CommonSpirit’s net loss ballooned to $738 million in the quarter as investments faltered, compared to a $413 million loss same time last year, according to its earnings report filed Wednesday
    • In the report, CommonSpirit also outlined plans to expand its ambulatory care footprint next year after a string of recent outpatient acquisitions in multiple states, despite liquidity concerns.

Tuesday Tidbits

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

From Washington, DC,

  • The New York Times reports,
    • “The House passed legislation on Tuesday to keep federal funding flowing into early 2024, after Democrats stepped in to rescue a plan opposed by many Republicans to avert a government shutdown at the end of the week.
    • “A coalition of Democrats and mainstream Republicans overcame the opposition of G.O.P. conservatives to approve the bill under special expedited procedures that required a supermajority. That approach, hatched by Speaker Mike Johnson, amounted to a gamble that a substantial number of Democrats would rally to help pass a package that Mr. Johnson’s own party was unwilling to back.
    • “The vote was 336 to 95, clearing the two-thirds threshold required for passage. In the end, 209 Democrats and 127 Republicans joined to pass the bill. Ninety-three Republicans opposed it, as did two Democrats.
    • “Senator Chuck Schumer of New York, the majority leader, told reporters that he wanted the Senate to vote on the bill “as soon as possible.”
  • The American Academy of Pediatrics News announced,
    • “The advisory was issued after the Food and Drug Administration (FDA) received 22 reports of high blood lead levels (BLLs) in children who consumed recalled fruit pouches that contain high levels of lead. The recall includes WanaBana brand apple cinnamon fruit puree pouches, Schnucks brand cinnamon applesauce pouches and Weis brand cinnamon applesauce pouches.”
  • ICD Monitor points out that “the new Healthcare Common Procedural Coding System (HCPCS) codes were released on Nov. 6. These codes include supplies, medications, implants, surgeries, etc. The latest release contained 553 changes and updates to the coding system . . . .
  • The Acting NIH Director Lawrence Tabak released his farewell issue of the NIH Directors blog.
    • “I congratulate Dr. Monica Bertagnolli as she takes the helm as the next permanent NIH director. Dr. Bertagnolli—an outstanding physician scientist—is a strong leader who will bring fresh, bold new ideas to NIH and the biomedical research enterprise. I know she’ll be in good hands thanks to the outstanding staff across NIH and the leadership in the Department of Health and Human Services. I look forward to supporting her efforts and continuing to ensure that NIH research optimizes health for all people.”

From the public health and medical research front,

  • MedPage Today informs us that early detection is the key to longer survival rates for people afflicted with pancreatic cancer.
  • NPR tells us,
    • “If your hearing begins to decline, your risk of falling may rise.
    • “Research shows older adults with mild hearing loss are at a greater risk — more than double — of falling. Though it’s not exactly clear how hearing loss increases the risk, it’s known that falls are the top cause of death from injury among people 65 and older.
    • “Now, new evidence shows that restoring hearing through the use of hearing aids may be protective, especially when people wear them consistently. That’s according to a study published this summer in the Journal of the American Geriatrics Society.”
  • The Wall Street Journal reports,
    • “Millions of adults struggle for years with chronic low-back pain—a disabling ailment that has no easy fix.
    • “Common causes include injury, arthritis and degenerative changes in the spine. It tends to start at midlife with the natural wear and tear of aging. But often there is no clearly identifiable physical cause, leaving patients to veer from one ineffective treatment to another—including highly addictive prescription opioids.
    • “Now, researchers are working on personalized treatment plans that can address physical, emotional and psychological traits in individual patients that influence the pain they are experiencing. Physical therapy, exercise, diet and lifestyle choices often play a role. Some research is also looking at ways to retrain the brain to think differently about pain.
    • “To be sure, low-back pain can be a sign of something life-threatening, such as cancer, or a severe spine condition that requires surgery. As a result, chronic low-back pain needs to be fully evaluated. But once “red flags” are eliminated, doctors need a more precise way to determine what will work for individual patients, says Dr. Matt Mauck, a researcher and pain-medicine physician at the University of North Carolina Chapel Hill’s UNC Pain Management Center.”
  • The Institute for Clinical and Economic Review “posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension (PAH).”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Midwest CEPAC) on December 1, 2023. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans announced,
    • “A new survey report from the International Foundation of Employee Benefit Plans reveals U.S. employer coverage and considerations surrounding glucagon-like peptide-1 (GLP-1) drugs, which have historically been used to treat diabetes. These drugs were also found to cause weight loss and have been subsequently used to treat obesity.
    • “Among survey respondents, 76% provide GLP-1 drug coverage for diabetes, 27% provide coverage for weight loss, and 13% are considering covering for weight loss.
    • “In 2023, the average representation of GLP-1 drugs used for weight loss in employers’ total annual claims was 6.9%, according to survey respondents. Those who are covering GLP-1 drugs are relying heavily on utilization management (79%) to control costs. A less common approach (32%) is step therapy. Fourteen percent of employers have no cost control mechanism in place.
    • “Though GLP-1 drugs have a high price tag, they currently represent only 6.9% of annual claims, according to survey respondents,” said Julie Stich, CEBS, Vice President of Content at the International Foundation. “Employers can take this information into account when designing long-and short-term benefit strategies.”
  • Bloomberg reports,
    • “Cigna Group is taking a page from billionaire Mark Cuban’s playbook to sell medicines for a set markup, the latest sign that companies that manage drug benefits are responding to pressure from upstart competitors.
    • “Next year Cigna’s Express Scripts subsidiary will offer employers and health plans the option to pay pharmacies up to 15% above their wholesale costs, plus an extra fee for dispensing the medicines. Employers now typically pay pharmacies based on an average discount, which can result in them paying more for drugs than a pharmacy charges.”
  • Reuters notes,
    • “Elevance Health (ELV.N) and Cigna Group’s (CI.N) Express Scripts unit on Monday settled the last pending claim in a long-running contract dispute, clearing the way for Elevance to appeal the dismissal of its $14.8 billion lawsuit accusing Express Scripts of overcharging it for prescription drugs.”
  • The Albany Times-Union reports that Empire Blue Cross is changing its name to Anthem Blue Cross.
    • “The company retains the Blue Cross Blue Shield name and remains part of the Blue Cross Blue Shield Association, which serves one in three insured Americans. * * *
    • “Empire joined Anthem in 2006, and the new name represents the next stage in the company’s journey to merge with the national brand, benefiting from combined resources and capabilities of its parent company and affiliates, company executives said.”
  • Per Fierce Healthcare,
    • “BeMe, a digital behavioral health app aimed at teenagers, has inked several partnerships with major payers, including $1.5 million in investment from Blue Cross and Blue Shield of Kansas (BCBSKS).
    • “Through the investment, BeMe’s platform will be made available to 20,000 teenagers across the Sunflower State. Executives said in an announcement that tools like BeMe will become increasingly critical as youth mental health issues continue to worsen.”

Happy Veterans’ Day

David Ermer–CDC, Congress, Mental health care, Rx coverage, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Veterans Day is being observed today because November 11 is a Saturday. Thanks for your service, vets.

From Washington, DC,

  • Reuters reports,
    • “U.S. Senate Majority Leader Chuck Schumer on Thursday took a procedural step to allow the Democratic-majority chamber to pass a stopgap government funding bill before a Nov. 17 deadline to avert a partial government shutdown.”
  • and
    • “U.S. House of Representatives Republicans aim to release a stopgap measure to avert a partial government shutdown [next] Saturday”
  • and
    • “Moody’s on Friday lowered its outlook on the U.S. credit rating to “negative” from “stable” citing large fiscal deficits and a decline in debt affordability, a move that drew immediate criticism from President Joe Biden’s administration.
    • “The move follows a rating downgrade of the sovereign by another ratings agency, Fitch, this year, which came after months of political brinkmanship around the U.S. debt ceiling.”
  • Forbes offers an overview of the situation.
    • “[T]here are 12 appropriations subcommittees that comprise the U.S. budget. The Senate has made progress on three of them, passing a bipartisan combined bill on November 1 for Agriculture; Veterans Affairs and Transportation; Housing and Urban Development.
    • “The House has so far passed bills for seven of the 12 budgetary areas, although further progress this week has stalled so far. House bills have been passed along partisan lines, and so they are unlikely to attract the necessary support within the Democratic-controlled Senate. In contrast, the Senate measures have been bipartisan.
    • “In addition, the text of the bill raising the debt limit includes automatic 1% cuts to the government’s entire budget if a full one is not passed by January 1, 2024. The intent of that measure was to incentivize relatively quick progress on the budget, rather than for the cuts to actually be implemented. Still it’s another deadline consideration in the budgetary process.”
  • MedTech Dive tells us,
    • “The Federal Trade Commission is challenging patents for 17 drugs marketed by Abbvie, AstraZeneca, GSK and other pharmaceutical companies, claiming Tuesday that the intellectual property was “improperly or inaccurately listed” in a regulatory database.
    • “The notice letters are largely about products with specialized injectors or inhalers, such as Viatris’ anaphylaxis shot EpiPen and GSK’s asthma drug Advair, which rely on those devices to deliver a precise dose. The FTC said it has filed a dispute with the Food and Drug Administration seeking to have the patents removed from the database, called the Orange Book.
    • “The FTC’s action comes two months after it approved a policy statement saying the agency would “use its full legal authority” to invalidate improperly listed patents. Drugmakers are increasingly under scrutiny for creating so-called “patent thickets” that make it difficult for generic challengers to enter the market.”

From the public health and research front,

  • NBC News reports,
    • “The number of kids whose caregivers are opting them out of routine childhood vaccines has reached an all-time high, the Centers for Disease Control and Prevention reported Thursday, potentially leaving hundreds of thousands of children unprotected against preventable diseases like measles and whooping cough. 
    • “The report did not dive into the reasons for the increase, but experts said the findings clearly reflect Americans’ growing unease about medicine in general.
    • “There is a rising distrust in the health care system,” said Dr. Amna Husain, a pediatrician in private practice in North Carolina, as well as a spokesperson for the American Academy of Pediatrics. Vaccine exemptions “have unfortunately trended upward with it.”
    • “The CDC report found that 3% of children entering kindergarten during the 2022-2023 school year were granted a vaccine exemption from their state. This is the highest exemption rate ever reported in the U.S.”
  • The Wall Street Journal points out,
    • “If you think canceling plans is always good self-care, you might want to think again. People who keep an active social calendar not only enjoy a better quality of life—they could also stave off an early trip to the grave.
    • “Loneliness and social isolation were linked to an increased risk of death from any cause, according to new research. That includes missing out on seeing loved ones, not having weekly group activities like a book club, or just often feeling lonely.
    • “Just like we need to make time in our busy lives to be physically active, we need to make time in our busy lives to be socially active,” said Julianne Holt-Lunstad, director of the Social Connection & Health Lab at Brigham Young University, who wasn’t involved in the report.
    • “A combination of several loneliness factors could be even more harmful, the data suggested. For example, having few family and friend visits was riskier when the person also lived alone.” 
  • Per Fierce Healthcare,
    • “Nearly two-thirds of specialty centers that conduct autism evaluations have wait times longer than four months, according to a new report.
    • “The report, focused on the state of pediatric autism diagnosis in the U.S., is based on a survey designed and conducted by Scott Badesch, former president of the Autism Society of America. Cognoa, maker of an FDA-approved, AI-powered diagnostic tool for autism, sponsored the study. The survey reached 111 specialty centers across the U.S., including hospitals, private practices, public health clinics, government agencies and academic entities. 
    • “Its findings underscore “how dysfunctional the current state of affairs is,” Cognoa’s CEO Sharief Taraman, M.D., told Fierce Healthcare.”
  • Medscape notes,
    • “The US Food and Drug Administration has approved fruquintinib (Fruzaqla, Takeda) for the treatment of certain adults with metastatic colorectal cancer who experience disease progression during or after prior treatment.
    • “More specifically, the approval extends to adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, in some cases, an anti-EGFR therapy.
    • “In a company press release, Takeda Pharmaceuticals said the drug “is the first targeted therapy approved for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in more than a decade.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Novo Nordisk plans to invest $6 billion to expand its drug manufacturing capacity as it tries to meet skyrocketing demand for its popular obesity and diabetes medicines Wegovy and Ozempic.
    • “The investment, announced by the Danish drugmaker Friday, will be spread over the next six years and builds on the company’s existing capital spending plans. Most of the money will go toward building a new plant for making active pharmaceutical ingredients, like the semaglutide protein that’s contained in both Wegovy and Ozempic.
    • “Construction, which will also add a new packaging facility, is expected to be completed in phases from the end of 2025 through 2029, Novo said. Once finished, the company expects the production site will employ 700 staff, with another 100 working at the packaging plant.”
  • Per Fierce Healthcare,
    • “As cold and flu season truly sets in, major home delivery platforms are now allowing customers to purchase products using their health benefits.
    • “Both DoorDash and Instacart announced this week that they would accept payments from health savings accounts and flexible spending accounts to cover the cost of health and wellness items. In particular, according to Instacart, this rollout will make it easier for people to take full advantage of their FSAs, as funds expire at the end of each year.
    • “In addition, some may find it difficult to use their HSA or FSA cards when making purchases at retail stores. Instacart said its new integration will allow for HSA and FSA payments from all retailers on its app that offer eligible items.”
  • According to the Society for Human Resource Management,
    • “According to a recent Gusto survey of over 300,000 small and midsize businesses, 30 percent of all employees in the professional services industries who get paid time off (PTO) have taken sick leave so far this year, an increase of 42 percent from 2019. 
    • “The average amount of sick time these workers have taken has increased by 15 percent since 2019 and is now 15.5 hours per year. The largest increase is among workers ages 25-34: Nearly a third (32 percent) of them have taken sick leave in 2023, compared to 28 percent of workers ages 35-54.”
  • AHIP announced,
    • AHIP joined with four other leading healthcare organizations to announce the Common Health Coalition: Together for Public Health.
    • The Common Health Coalition is focused on translating the hard-won lessons and successes of the COVID-19 pandemic response into actionable strategies that will strengthen the partnership between our healthcare and public health systems. The Coalition is the product of a joint commitment to public health made in March 2023 by founding members AHIP, the Alliance of Community Health Plans, the American Hospital Association, the American Medical Association, and Kaiser Permanente. 
    • In early 2024, the Coalition will publish recommendations informed by technical advisory groups of subject matter experts and an advisory council of public health leaders. The recommendations will focus on 4 initial priority areas:
      • spearheading greater coordination between the public health and healthcare systems;
      • building shared, well-maintained emergency preparedness plans;
      • establishing national standards for health care data that help identify health disparities; and
      • and modernizing infectious disease detection.
    • The development of these recommendations is being facilitated by ChangeLab Solutions, a national nonprofit that uses the tools of law and policy to advance health equity.

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.”

Friday Factoids

David Ermer–CDC, CMS, Congress, Electronic health records, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Department of Health and Human Services discusses its efforts to support rural healthcare.
  • Today, the proposed No Surprises Act regulation that would change current Independent Dispute Resolution processes was published in the Federal Register. OPM’s proposed FEHB rules changes are described on page 75,808 and may be found on page 75,851.
  • The Centers for Medicare and Medicaid Service issued FAQs on its new final rule imposing civil monetary penalties on Section 111 reporting violations. The rule, which impacts FEHB carriers, becomes enforceable on October 11, 2024.
  • Congressman Gerry Connolly (D VA) released a “statement in support of the Office of Personnel Management’s (OPM) expansion of infertility coverage benefits for Federal Employee Health Benefits (FEHB) program enrollees.” The FEHBlog is pleased to read about Congressman Connolly’s support.
  • The Office of the National Coordinator of Health Information Technology created a blog post titled “Coming in Hot! TEFCA Will Soon Be Live and Add Support for FHIR-Based Exchange.” The post indicates that this critically important electronic health record key to data sharing will be going live soon.
    • “Our TEFCA timelines will remain aggressive and ambitious as ONC and the RCE help support the industry to usher in a new era of data exchange for the United States.
    • “For more information on TEFCA in general, please check out the RCE resources and sign up for the RCE newsletter and monthly public calls.”
  • Govexec reports, “The Office of Personnel Management on Friday announced new plans aimed at helping the federal government’s HR agency better weather the annual surge of retirement applications from departing federal employees that occurs each winter.” Good luck.
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission opened its 2022 EEO-1 Component 1 data collection Oct. 31. Reports must be submitted by Dec. 5, the agency said in a news release. 
    • “The EEO-1 Component 1 report is a mandatory demographic data report the EEOC requires from all private-sector employers with 100 or more employees, and from certain federal contractors.
    • “EEOC’s Office of Enterprise Data and Analytics released a booklet to help filers complete the process. It has also provided a Filer Support Team Message Center and other resources, the agency said.”

From the public health front,

  • The Centers for Disease Control posted its inaugural issue of FluSight for the current flu season. Here’s the kickoff forecast.
  • Health Payer Intelligence explains how public and private payers cover healthcare for the LGBTQ+ community.
  • The Institute for Clinical and Economic Research published
    • “its third annual “Barriers to Fair Access” assessment of prescription drug coverage policies (Report |Supplemental Materials) within US commercial insurance and the Veterans Health Administration. The analysis found that major payer coverage policies for 18 drugs often met fair access criteria for cost sharing, clinical eligibility, step therapy, and provider restrictions. However, the report’s findings suggest that major improvements are needed in the transparency of coverage policy information for consumers and in detailing out-of-pocket costs for patients.” 
  • Beckers Hospital Review shares CMS statistics on emergency department wait times across our country.
  • The Wall Street Journal gives advice on how to avoid the gloom associated with turning the clock to standard time this weekend.
    • “Daylight hours affect our brain chemistry. As days grow shorter, light receptors in the eyes receive less light and send a signal to the brain about what chemicals to produce, says Lina Begdache, associate professor of health and wellness studies at Binghamton University. 
    • “Our brains begin producing more melatonin—the sleep-related hormone—and less serotonin, which enhances mood and controls appetite. When the brain starts making more melatonin at 4 p.m. due to the earlier dusk, people can feel prematurely sluggish, which can affect mood, diet, exercise and sleep patterns.  
    • “Focusing on improving one area that is affected by the time change, such as exercise, can help the others and might be more doable than trying to improve everything at once, says Begdache, the associate health and wellness studies professor.  * * *
    • “If you improve your diet, you’re more likely to exercise more. And if you exercise more, you’re more likely to sleep better,” says Begdache, who led a 2021 study on mental well-being and seasonal changes. “
  • The FEHBlog personally likes having more sunlight in the morning.

From the U.S. healthcare business front,

  • Here’s a link to the American Medical Association’s reaction to the 2024 Medicare Part B pay cut announced this week. The pay cut is a wash for FEHB carriers because the cut applicable to Medicare prime annuitants will be offset by price increases for younger members. The big problem is that the cut will drive more doctors out of Medicare Part B. When the FEHBlog, who is on traditional Medicare, lived inside the Beltway, his primary care doctor joined the crowd of local PCPs who had dropped out of Medicare. When the FEHBlog moved to Texas last year, he had no problem finding a PCP who takes Medicare, and what’s more, his PCP participates in an accountable care organization. Access to affordable healthcare and dental care is better in central Texas than inside the Beltway, at least for now. The FEHBlog agrees with the AMA that Congress needs to step up.
  • BioPharma Dive informs us,
    • “Moderna on Thursday shifted its revenue forecast for the year to “at least” $6 billion from a previous range of between $6 billion to $8 billion, a change it said reflected COVID-19 vaccination trends in the U.S.
    • “The biotechnology company also disclosed third-quarter earnings showing a net loss of $3.6 billion, driven mainly by non-cash charges of $3.1 billion related to a “manufacturing resizing” and a tax charge. Shares slumped 6% Thursday on the news but traded up Friday morning.
    • “Moderna said it plans to break even in 2026 through “disciplined investment” and launches for new products like its mRNA flu and respiratory syncytial virus vaccines as well as a combination flu and COVID shot.”
  • MedTech Dive shares medtech executives’ views on the new GLP-1 obesity drugs.
    • “Strong patient interest in GLP-1 drugs to treat obesity has prompted medtech companies to take a hard look at the potential impact on demand for procedures like bariatric surgery and products such as glucose monitors and sleep apnea devices.
    • “The potential threat to medical device sales has spooked investors, who have sold shares in companies across the sector.
    • “Fears that medications such as Ozempic, Mounjaro and Wegovy, which are used for diabetes and weight loss, will eventually reshape treatment for a variety of diseases have driven the most severe correction in the medtech sector since the onset of COVID-19, wiping out about $370 billion in market capitalization, according to Mizuho analyst Anthony Petrone.”

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.”