Midweek update

Midweek update

Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call informs us,
    • “Congress appears poised to leave town before Christmas without a topline spending agreement, which could doom the chances of getting full-fledged fiscal 2024 appropriations bills done in January.
    • “If there’s no deal on spending limits this week, lawmakers will essentially be out of time to work out the details of the 12 annual appropriations bills by Jan. 19, the first of two deadlines set in the last continuing resolution. The next deadline is Feb. 2, leaving little time to complete the last, larger batch of bills, particularly with the House scheduled to be in recess the week of Jan. 22.
    • “House Republicans remain far apart from both parties in the Senate and House Democrats on the total allocations appropriators have to parcel out to the dozen subcommittees so they can wrap up their bills.”
  • Health Affairs Forefront informs us,
    • Today, Micah Hartman and colleagues at the Centers for Medicare and Medicaid Services (CMS), including the National Health Expenditure Accounts Team, released their 2022 healthcare spending report.
    • The team finds that healthcare spending in the US grew 4.1 percent from 2021, reaching $4.5 trillion in 2022, which is a faster rate of growth than in 2021 but slower than in 2020.
    • They determine that the rate of growth has become more consistent with the prepandemic average annual growth rate of 4.4 percent.
    • Among other findings, they determine that the health share of GDP returned to a nearly prepandemic level in 2022, although this result was partly influenced by economywide inflation. 
    • In 2022, the insured share of the population reached 92.0 percent (a historic high), as private health insurance and Medicaid enrollment continued to experience strong growth.
  • Here’s a link to the CMS Fact Sheet on this report.
  • “The U.S. Department of Health and Human Services (HHS) through the Office of the National Coordinator for Health Information Technology (ONC) today finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. This follows the release of the HTI-1 proposed rule in April 2023. The HTI-1 final rule advances patient access, interoperability, and standards.”
    • Here’s a link to the Fierce Healthcare article on this action.
  • Health Affairs Forefront offers an article by two top government experts on what’s next with TEFCA.

From the U.S. public health and medical research front,

  • Beckers Hospital Review points out,
    • “JN.1 is now the fastest-growing COVID-19 variant in the U.S., accounting for around 21% of cases, data from the CDC shows.
    • “The strain is closely related to BA.2.86, which first caught experts’ attention over the summer because of its large number of mutations in the spike protein. JN.1 has a single additional change in its spike protein, the L455S mutation, which experts say has some immune-evasion properties worth keeping an eye on.
    • “The continued growth of JN.1 suggests that it is either more transmissible or better at evading our immune systems,” the CDC said in a recent update about the variant. “At this time, there is no evidence that JN.1 presents an increased risk to public health relative to other currently circulating variants.” 
  • The New York Times reports,
    • “The nausea and vomiting that often define the first trimester of pregnancy are primarily caused by a single hormone, according to a study published on Wednesday in the journal Nature. Researchers said that the discovery could lead to better treatments for morning sickness, including rare, life-threatening cases of it.
    • “The study confirms prior research that had pointed to the hormone, called GDF15. The researchers found that the amount of hormone circulating in a woman’s blood during pregnancy — as well as her exposure to it before pregnancy — drives the severity of her symptoms.”
  • The New York Times also offers an expert opinion on how to close the large addiction treatment gap.
    • “The single most important thing lawmakers and health officials could do to usher in such changes is to improve their oversight of the addiction treatment industry. Too many states have not updated their regulations for addiction treatment facilities since the 1960s or ’70s. Many rely instead on independent accrediting agencies to separate good programs from bad ones. That approach frequently fails, as secret shopper studies and innumerable investigative reports have shown. “Accrediting organizations should feel humiliated by what we’ve seen from facilities that have their stamp of approval,” said Keith Humphreys. “But their incentive is to accredit everyone, because that’s how they get paid.”
  • Medscape notes,
    • “New recommendations to screen for heart failureperipheral arterial disease (PAD), and type 1 diabetes risk, along with new obesity management guidance, are among many updates to the American Diabetes Association’s (ADA’s) Standards of Care for 2024.
    • “The Standards of Care are essentially the global guidelines for the care of individuals with diabetes and those at risk,” ADA chief scientific and medical officer Robert Gabbay, MD, PhD, said during a briefing announcing the new Standards.”
  • Per MedPage Today,
    • “A high-dose recombinant influenza vaccine (Flublok Quadrivalent) was more protective than an egg-based standard-dose influenza vaccine in adults, according to results of a cluster-randomized, observational study.
    • Among adults ages 50 to 64, the high-dose vaccine was 15.3% more effective in preventing influenza than the standard-dose vaccine (95% CI 5.9-23.8, P=0.002) and 15.7% more effective against influenza A (95% CI 6.0-24.5, P=0.002), reported Nicola Klein, MD, PhD, from the Kaiser Permanente Vaccine Study Center in Oakland, California, and colleagues in the New England Journal of Medicine.
    • “Although the relative benefit of the high-dose vaccine appears to be modest, “reducing breakthrough influenza cases by 15% would provide a substantial public health benefit, especially during more severe influenza seasons,” Klein told MedPage Today in an email.”
  • and
    • Moderna’s mRNA-based RSV vaccine was effective at preventing RSV-associated lower respiratory tract disease in adults ages 60 and older, according to results of the randomized ConquerRSV trial.
    • The mRNA-1345 vaccine was 83.7% effective (95.88% CI 66%-92.2%) in preventing RSV-associated lower respiratory tract disease with at least two signs or symptoms, and similarly effective (82.4%) against lower respiratory tract disease with at least three signs or symptoms (96.36% CI 34.8%-95.3%), Eleanor Wilson, MD, of Moderna in Cambridge, Massachusetts, and colleagues reported in the New England Journal of Medicine. * * *
    • “An important consideration will be how much protection an mRNA vaccine provides during subsequent RSV seasons and whether subsequent boosting will be appropriate,” Angela Cohn, MD, and Aron Hall, DVM, MSPH, from the National Center for Immunization and Respiratory Diseases at the CDC in Atlanta, wrote in an accompanying editorial. “Such questions about duration of immunity, along with reactogenicity and cold-chain considerations, remain important areas for further evaluation in the implementation of mRNA vaccines.”
  • The National Institute on Drug Abuse announced,
    • The percentage of adolescents reporting they used any illicit substances in 2023 continued to hold steady below the pre-pandemic levels reported in 2020, with 10.9% of eighth graders, 19.8% of 10th graders, and 31.2% of 12th graders reporting any illicit drug use in the past year, according to the latest results from the Monitoring the Future survey. Reported use for almost all substances decreased dramatically between 2020 and 2021, after the onset of the COVID-19 pandemic and related changes like school closures and social distancing. In 2022, most reported substance use among adolescents held steady at these lowered levels, and these latest data show that this trend has continued into 2023.

From the U.S. healthcare business front,

  • We have another report on healthcare spending trends.
    • “Greater use of diagnostic testing and advances in medical technology and treatments are among the factors pushing medical trends higher than the rate of inflation, according the 45th National Healthcare Trend Survey, published by Buck, a Gallagher company, an integrated HR, pensions, and benefits consulting, technology, and administration services firm. The company has been monitoring medical trend factors used by health insurers and third-party administrations to project employers’ future healthcare costs since 1999.
    • “The survey of nearly 100 health insurers and health plan administrators covering more than 100 million plan participants predicts even higher medical trend factors in the future due to providers renegotiating higher fees with insurers, as well as other changes occurring in the healthcare industry. Compared to the prior survey released in May 2023, the latest trends are up 50 to 100 basis points.”
  • Reuters reports,
    • “More than a quarter of 152 employers surveyed by the Business Group on Health said they would use virtual providers to oversee obesity drug prescriptions next year.
    • “Boeing (BA.N), Hilton (HLT.N), and Fortune Brands (FBIN.N) are among companies that have signed up for or expanded deals with virtual healthcare providers, according to sources familiar with the matter.
    • “Truist analyst Jailendra Singh forecasts the market for virtual obesity drug management could reach $700 million in 2024 and grow to as much as $9 billion longer term, assuming providers charge around $30 per member, per month, and $50 for physician appointments.”
  • The Wall Street Journal reports,
    • Pfizer PFE  shares tumbled to their lowest close in more than nine years, after the giant drugmaker overestimated Covid-19 vaccine use and the company was forced to warn about its prospects.
    • “Shares fell 6.7% on Wednesday because the company, which has lost $140 billion in market cap this year, said its revenue could fall next year and issued 2024 guidance below analyst expectations.”

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC,

  • The U.S. Supreme Court granted the federal government’s request to direct three U.S. Courts of Appeals to vacate decisions they made in cases involving the federal government employee Covid vaccine mandate on the ground that the President had withdrawn the mandate. In short, the Court held that the cases are moot.
  • Bloomberg reports,
    • “Employer groups are lining up behind legislation headed to the House floor that would prevent medical groups owned by hospitals from charging more for services than private providers. 
    • “The Lower Costs, More Transparency Act (H.R. 5378) includes provisions that would require “site-neutral” payments for drug administration in off-campus hospital outpatient departments. The measure, which has bipartisan support, could come to a vote in the House as early as Monday. 
    • “Although the measure only applies to Medicare, employers say site-neutral payments could spill over to reduce costs for commercial plans. They argue the additional fees hospital-owned practices are charging aren’t necessary for services that can be safely performed in a doctor’s office, while hospitals counter that the legislation will lead to reduced oversight and lower quality of care.” * * *
    • The American Hospital Association blasted site neutral proposals.
  • P.S. The House of Representatives passed H.R. 5378 by a bipartisan 320-71 vote.
  • According to a press release, “AHIP is pleased to announce the appointment of Mike Tuffin as its next President and CEO, effective January 8, 2024. Tuffin returns to AHIP having served as its Executive Vice President for Public Affairs from 2003 to 2012. He succeeds Julie Simon Miller, AHIP’s General Counsel, who has served as Interim CEO since September 2023.” Good luck.
  • The Sequoia Project is releasing five new TEFCA resources. TEFCA will be the long-overdue backbone for connecting the country’s various electronic health record networks.
  • Mercer Consulting discusses Rx legislative activity to watch in 2024.

From the public health front,

  • Beckers Hospital Review tells us,
    • “Data from the CDC and anecdotal reports form hospital officials suggest respiratory syncytial virus infections have peaked in the U.S., allaying concerns that the nation could see simultaneous surges of COVID-19, flu and RSV.
    • “We think we’re near the peak of RSV season or will be in the next week or so,” CDC Director Mandy Cohen, MD, told NBC News in a Dec. 1 report. 
    • “National data aligns with that forecast. Weekly emergency department visits for RSV had been on the rise since September. Now, they may be coming down again, CDC data indicates. There were 22,321 ED visits for RSV for the week ending Dec. 2, the latest for which data are available. That’s down from 23,500 in the previous week. PCR test positivity rates also fell slightly to 11.7 from 12.7 in the previous week.” 
  • The Washington Post adds,
    • “Up to 5.4 million people in the United States already have been sick with the flu this fall, according to data compiled by the Centers for Disease Control and Prevention. The agency also estimates that flu has caused as many as 55,000 hospitalizations and 4,600 deaths from Oct. 1 through Dec. 2.
    • “As flu season progresses, usually peaking between December and February, the CDC plans to update its tally of flu-related cases weekly. The flu, or influenza, is a highly contagious respiratory infection caused by viruses that spread from person to person, often via droplets expelled through coughing or sneezing.
    • “The flu, like colds and other respiratory illnesses, is more common in cold weather as people tend to spend more time indoors, where viruses can pass more easily from person to person. Also, health experts believe the flu virus survives better in cold weather and cold, dry air weakens people’s resistance.”
  • The CDC has posted the latest COVID statistics.
  • The AP reports,
    • “Health officials on Friday released the first nationally representative estimate of how many U.S. adults have chronic fatigue syndrome: 3.3 million.
    • “The Centers for Disease Control and Prevention’s number is larger than previous studies have suggested, and is likely boosted by some of the patients with long COVID. The condition clearly “is not a rare illness,” said the CDC’s Dr. Elizabeth Unger, one of the report’s co-authors. 
    • “Chronic fatigue is characterized by at least six months of severe exhaustion not helped by bed rest. Patients also report pain, brain fog and other symptoms that can get worse after exercise, work or other activity. There is no cure, and no blood test or scan to enable a quick diagnosis.”
  • Beckers Hospital Review informs us,
    • “Patients taking Novo Nordisk’s weight loss drug Wegovy in 2021 and 2022 were three times more likely to continue taking the medication a year later compared to older weight loss therapies, according to a study published Dec. 6 in Obesity
    • “Researchers from Cleveland Clinic evaluated about 1,000 EHRs between January 2015 and July 2023 among patients who were taking anti-obesity medications. The EHRs were collected from a large health system in Ohio and Florida. 
    • “The weight loss drug with the highest adherence was Wegovy (semaglutide), with 40% of Wegovy patients still filling prescriptions after a year. In comparison, the adherence of orlistat, liraglutide, naltrexone-bupropion and phentermine-topiramate after 12 months ranged between 0% and 19%.” 
  • The American Medical Association lets us know what doctors wish their patients knew about pickleball injuries.

From the U.S. healthcare business front,

  • MedCity News identifies five trends shaping healthcare business strategies for 2024.
    • M&A
    • Generative AI
    • Workforce Challenges
    • Outsourcing
    • Affordability
  • Per Fierce Healthcare and because many FEHB plans offer global coverage
    • “More than half of global health insurers are expecting significant increases in healthcare costs over the next several years, according to a new report.
    • “Analysts at advisory firm WTW surveyed 266 insurers across 66 countries and found that 58% are bracing for “higher or significantly higher” cost increases in the three upcoming years. The report found that global medical costs increased by 10.7% in 2023, a record high and up from a 7.4% increase in 2022.
    • “The average cost trend insurers expect is 9.9% next year, which accounts for variations in rates between regions. For example, the estimated rate of cost increases decreased from 10.9% in 2023 to 9.3% in 2024, while it’s projected to rise from 11.3% in 2023 to 12.1% in 2024 in the Middle East and Africa, according to the report.”
  • Fierce Healthcare also reports,
    • “Healthcare technology giant Epic is leveraging its massive clinical research database, with data on 226 million patients, to develop a next-generation decision support tool for clinicians.
    • “Elevance Health, formerly Anthem and the nation’s second-largest insurer, leverages its clinical data platform, called Health OS, and artificial intelligence to help providers close gaps in care and reduce burdensome paperwork, according to CEO Gail Boudreaux.
    • “The insurer’s goal is to break down data silos and integrate data on patients’ physical, mental and social health into a longitudinal patient record within electronic health record (EHR) systems, Boudreaux said during the Forbes Healthcare Summit this week in New York City.”
  • Beckers Hospital Review identifies the eight most influential drugs approved by the FDA this year, according to GoodRx, while the Institute for Clinical and Economic Review (ICER)
    • published its latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States. Among the top 10 drugs with net price increases in 2022 that had substantial effects on US spending, ICER determined that eight lacked adequate new evidence to support any price increase. The analysis also found that one of three Medicare Part B drugs with high list price increases in 2021 lacked adequate supporting new evidence, directly raising annual out-of-pocket expenses for Medicare patients by up to $680 per year.”
  • Beckers Payer Issues offers seven prior authorization updates.
  • Beckers Hospital Review identifies nine hospitals already cleared to administer the new CRISPR treatment for sickle cell anemia that FDA approved last week. Also, “[re]ad more about the treatment and experts’ reactions here.” 

Midweek update

Photo by Hugo Clément on Unsplash

From Washington, DC

  • STAT New reports,
    • “The White House is throwing its support behind a controversial authority that allows the government to claw back patents for certain high-priced medicines, according to three sources familiar with the plans. It’s an early step that could have major ramifications for the American pharmaceutical industry, depending on whether and how federal officials actually use the authority.
    • “The administration will on Thursday issue a framework for the National Institutes of Health to more broadly use so-called “march-in rights” — a policy that allows it to seize patents from drugmakers whose products rely on federally funded research, according to the three people familiar with the plans. The framework will lay out when the agency might assert this authority, and endorse using a drug’s price in that determination, the sources said. * * *
    • “[T]he framework will likely include a number of conditions limiting its use, two sources said. The public — including pharmaceutical companies — will also get the chance to weigh in on the idea before it is finalized.”
    • Neverthless, the FEHBlog hears the litigation turbobillers revving up.
  • American Hospital Association News tells us,
    • “A bipartisan group of senators this week introduced the Protect Rural Seniors’ Access to Care Act, AHA-supported legislation that would prohibit the Health and Human Services Secretary from finalizing a proposed rule on minimum staffing for long-term care facilities.
    • “AHA has urged the Centers for Medicare & Medicaid Services not to finalize the rule and instead develop more patient- and workforce-centered approaches focused on ensuring a continual process of safe staffing in nursing facilities.
    • “Over 90 organizations have endorsed the bill, introduced by Sens. Deb Fischer, R-Neb., Roger Marshall, R-Kan., Jon Tester, D-Mont., James Lankford, R-Okla., Joe Manchin, D-W.Va., Roger Wicker, R-Miss., Kyrsten Sinema, I-Ariz., Susan Collins, R-Maine, and Angus King, I-Maine.
    • “Rep. Michelle Fischbach, R-Minn., introduced a House version of the bill in September.”
    •  Fingers crossed for the bill to enacted. The HHS rule is short sighted.

In FEHB Open Season news, Govexec, Federal News Network, and FedWeek offer tips for last-minute shoppers as we approach the end of the Federal Benefits Open Season next Monday. What’s more, FedWeek offers advice on protecting your survivor’s access to FEHB coverage.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid-19 test positivity rates increased over the summer and then stabilized earlier this fall. They have recently ticked back up, rising 1.2% for the latest week, according to the CDC’s most recent data. Emergency department visits and hospitalizations are up about 10% over the same period. 
    • “Scientists and public-health officials say that data understates the current virus spread and point to elevated levels of the virus detected in wastewater. Wastewater levels are an early warning for infections, with levels up nationally since mid-October. * * *
    • [Variant] JN.1 * * * is growing rapidly on a global level, says Jesse Bloom, a virologist and professor at Fred Hutchinson Cancer Center in Seattle. It has quickly spread in countries such as France and England. JN.1 has been detected in the U.S., though only as a blip.
    • Epidemiologist Katelyn Jetelina, a scientific adviser to the CDC and author of the “Your Local Epidemiologist” newsletter [available on Substack], says that while JN.1 isn’t growing as fast as the original Omicron in the winter of 2021-22, its current rate of growth could fuel a wave in Covid-19 cases. 
    • “If that rate continues, we should see dominance in the U.S. around Christmastime, which means that it would really jump-start a wave around New Year’s,” she says.
    • The good news, says Bloom, is that research indicates the new booster—developed to protect against the XBB variants that were dominant this summer—appears to work for the more mutated newer variants, too.
  • Here’s a link to the National Cancer Institute’s research newsletter.
  • Beckers Hospital Review informs us,
    • “More than a third of mothers — around 40 million women — are affected by lingering health issues after giving birth, according to a new study published Dec. 6 in The Lancet Global Health.
    • “However, many of the issues they report experiencing after giving birth extend long after they stop receiving postpartum care, which is where the major issues lie, according to the researchers.
    • “The authors found that after giving birth, 32% of women report low back pain, 19% experience anal incontinence, 11% experience perineal pain, 8-31% are affected by urinary incontinence, and around 11% are affected by secondary infertility issues. Mental health issues like anxiety and depression are also pervasive.”

From the U.S. healthcare business front,

  • Bloomberg reports,
    • Eli Lilly & Co.’s new weight-loss drug Zepbound is now available at US pharmacies, offering an alternative to rival medications like Novo Nordisk A/S’s Wegovy as supply issues persist. 
    • “Zepbound was approved by the US Food and Drug Administrationin early November as a treatment for people with obesity. Patients with a prescription from their doctor will now be able to get the drug, which was added to the list of available drugs for Express Scripts and Cigna Healthcare this month, Lilly said in a statement Tuesday.”
  • BioPharma Dive points out,
    • “AbbVie is restocking its drug pipeline in a big way, announcing Wednesday an $8.7 billion deal to buy neuroscience-focused Cerevel Therapeutics, just days after agreeing to a similar sized acquisition of the cancer biotechnology company ImmunoGen.
    • “Per the deal, AbbVie will pay $45 per share of Cerevel, which is developing medicines for schizophrenia, dementia and Parkinson’s disease. The buyout price is 22% higher than Cerevel stock’s closing price Wednesday and 73% above what shares closed at Friday, before rumors of a pending deal emerged. 
    • “Both companies’ boards of directors have agreed to the acquisition, which they expect will close sometime around the middle of next year.”
  • Per Fierce Healthcare,
    • “Elevance Health’s pharmacy benefit manager is launching a new digital pharmacy that aims to make it easier for members to track their prescriptions.
    • “CarelonRx Pharmacy will launch on Jan. 1, and members will be able to connect with pharmacists via text, chat or phone around the clock. The platform will also allow them to check the price of medications for comparison and track their prescriptions throughout the order process, similar to how a customer may follow a pizza order.
    • “The pharmacy will also use push notifications to keep members up-to-date on their prescriptions and will allow them to use text messaging to connect directly with representatives.”
  • and
    • “Many of the past year’s buzziest topics and omnipresent struggles will likely rear their heads as major talking points across 2024, per the year-ahead predictions of Deloitte’s healthcare industry heads.
    • “A disruptive pandemic, rapid digital transformation and mounting cost pressures have taken their toll on the industry’s decisionmakers, Deloitte’s healthcare sector leader Tina Wheeler and senior manager of its health solutions center Wendy Gerhardt wrote in a Wednesday outlook writeup.
    • “The pair highlighted a recent annual survey of 60 executives that found that only 3% of health system executives and 7% of health plan executives had a “positive” outlook for the coming year—down from the respective 15% and 40% of the prior year’s survey.
    • “However, there are some bright spots to consider as the industry undergoes convergence,” which the authors described as “the disruption of traditional health care stakeholders, entrance of new players like retailers and tech companies and the reassembly of a new ecosystem that creates opportunities.”
  • Health Payer Intelligence lets us know,
    • “Cardiovascular, diabetes, and obesity treatments are a critical part of women’s health, and employers can take steps to ensure that women have access to information and care related to their hearts, a flipbook from Northeast Business Group on Health (NEBGH) emphasized.
    • “With women comprising more than half of today’s workforce, employers are making women’s health and well-being a top priority, and rightfully so,” Candice Sherman, chief of executive officer of NEBGH, said in the press release.
    • “Cardiovascular disease in women is underdiagnosed and undertreated. Employers can play an important role in raising awareness and educating employees about heart disease and risk factors like diabetes and obesity as well as providing wellness and benefit programs that support women’s health. We developed this guide to give employers a tool to develop ways to improve the overall heart health of their workforce.”

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC,

  • STAT News informs us,
    • “The Senate health care committee will consider a sweeping bill next week meant to combat the opioid epidemic, according to four lobbyists and a congressional aide familiar with the legislation. 
    • “The proposal would reauthorize a number of programs first created by the SUPPORT Act, an addiction-focused bill that Congress first passed in 2018. Many of those programs’ authorizations expired earlier this year, however, leading addiction treatment advocates to fret that lawmakers — and specifically the committee’s chairman, Sen. Bernie Sanders (I-Vt.) — no longer view the issue as a priority.    
    • “If passed, the legislation would mark Capitol Hill’s first major action this year on the addiction crisis. Current data shows that roughly 110,000 Americans are dying of drug overdoses each year. Roughly 85,000 of those overdoses involve opioids.” 
  • The Department of Health and Human Services announced,
    • “Today, United States Surgeon General Dr. Vivek Murthy is launching the 5-for-5 Connection Challenge, calling on Americans to take five actions over five days to build more connection in their lives. Dr. Murthy recently issued this challenge to students across the country on his “We Are Made to Connect” College Tour, which concluded just last week. Now, as we enter the holiday season, the 5-for-5 Connection Challenge aims to inspire people of all ages to build, strengthen, and prioritize their relationships.
    • “For the next two weeks, from December 4th – December 15th, the Surgeon General will encourage people to take five actions over five days that express gratitude, offer support to, or ask for help from people in their lives. These types of actions are outlined in the Surgeon General’s Advisory on Our Epidemic of Loneliness – PDF as some of the ways that people can catalyze social connection. As outlined in the Advisory, social connection can advance physical, mental, and cognitive health, and it is even associated with a decreased risk of mortality.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration is evaluating the potential for plastic syringes made in China to suffer problems such as leaks and breakages.
    • “Officials began the investigation after receiving information about quality issues associated with “several Chinese manufacturers of syringes” that made them concerned that some devices “may not provide consistent and adequate quality or performance.”
    • “The FDA is advising consumers and healthcare providers to check where syringes are made and “consider using syringes not manufactured in China, if possible.” The advice applies to plastic syringes used for injecting fluids into, or withdrawing fluids from, the body.”

In FEHB Open Season news, Govexec offers helpful, last-minute advice from Kevin Moss.

From the public health and medicare research front,

  • U.S. News and World Report points out,
    • “After a period of limited change, COVID-19 activity is increasing again especially in the Midwest and Mid-Atlantic regions,” the CDC said in a report published Friday.
    • “Federal health officials are likely watching the increase given that they expect a “moderate” winter wave of coronavirus and this could be the start of it. Holiday gatherings and travel are also typically followed by an increase in coronavirus cases and hospitalizations.
    • “COVID-19 vaccination rates, meanwhile, have been disappointing for many.
    • “CDC Director Mandy Cohen told Congress this week that about 16% of Americans have gotten the updated COVID-19 vaccine.
    • “That’s not enough,” Cohen said.”
  • Beckers Hospital Review notes,
    • “So far this year, the CDC estimates there have been at least 1.8 million illnesses, 17,000 hospitalizations, and 1,100 deaths from flu in the U.S. 
    • “Influenza A continues to be the dominant strain in circulation, making up around 82% of cases, while influenza B is only accounting for around 18%. 
    • “Louisiana and South Carolina are still reporting the highest levels of flu activity in the country. 
    • “Nine states are experiencing high activity levels, but less than the two states above, including: California, New Mexico, Texas, Mississippi, Alabama, Georgia, Colorado, Florida and Tennessee. 
    • “Cases are also high in New York City and Puerto Rico.”
  • The Journal of the American Medical Association presented the following study results:
    • Question  Is smoking still decreasing among US adults and do the trends vary by age, income, and race and ethnicity?
    • Findings  In this cross-sectional study of 353 555 adults responding to the 2011 to 2022 National Health Interview Surveys, adults younger than 40 years had dramatic declines in smoking prevalence during the last decade, especially among those with higher incomes. In contrast, relatively slow declines were observed among adults aged 40 to 64 years, with no decrease in smoking among those 65 years or older.
    • Meaning  These findings suggest that the precipitous decline in smoking among younger adults should be maintained, but that additional efforts are required to further reduce smoking in older adults.”
  • The American Medical Association explains “What doctors wish patients knew to improve their mental health.”
  • Per Endocrinology Advisor, “Decreased mortality risk is associated with concomitant reductions in glycated hemoglobin (HbA1c) and body weight among patients with type 2 diabetes, according to study results published in Diabetes Obesity and Metabolism.”

From the U.S. healthcare business front,

  • Fierce Healthcare profiles ten women of influence in U.S. healthcare. Check it out.
  • BioPharma Dive reports
    • “Roche on Monday agreed to acquire biotechnology company Carmot Therapeutics in a deal that bulks up the Swiss pharmaceutical giant’s pipeline with a group of weight loss drugs in early clinical testing.
    • “Roche will pay $2.7 billion upfront for the Berkeley, California-based Carmot. Roche could owe as much as $400 million more in future payments to Carmot shareholders, among them The Column Group and RA Capital, if certain milestones are met. The companies expect the acquisition to close next year.
    • “The deal hands Roche a trio of drugs in human testing for obesity, an area of pharmaceutical research that has been catalyzed by the success of weight loss medicines like Wegovy and Zepbound. Their progress has fueled a gold rush among large drugmakers, a number of which are either advancing in-house medicines or inking deals to acquire new prospects.”
  • and
    • “The Food and Drug Administration granted conditional approval to Eli Lilly’s oral cancer drug Jaypirca in two types of blood cancer, expanding its use from a rare type of lymphoma to people with leukemia and lymphoma patients who have previously received two other treatments, the company said Friday.
    • “Jaypirca is the fourth of a group of drugs called BTK inhibitors, a class that includes AbbVie and Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence. It gained approval earlier this year and posted $42 million in sales through Sept. 30.
    • “With this approval, Jaypirca can now be used in chronic lymphocytic leukemia or small lymphocytic lymphoma after patients have been treated with AbbVie and Roche’s Venclexta and another BTK inhibitor. Lilly said a Phase 3 trial meant to confirm Jaypirca’s accelerated approval has already met its primary goal.”
  • HR Dive discusses “Why EAPs go unused despite growing mental health awareness; Many factors contribute to the historic underutilization of employee assistance programs, despite their value as an access point to quality care.”
  • Medscape offers an infographic on how doctors grade their EHR systems while MedCity News explains how improved coding quality by healthcare providers can prevent denials and improve cash flow.
  • Health Payer Intelligence adds,
    • “Payers are investing in healthcare IT resources to support cost optimization and improve member experience, according to a study from EY-Parthenon and KLAS Research.
    • “As payers face operational and financial pressures, they are turning to healthcare IT solutions for help. Researchers sought to understand what strategies payers prioritize, how much they spend on healthcare IT resources, and what future investments look like.
    • “The study findings reflect responses from over 100 executives across payer entities serving commercial, Medicare, and Medicaid populations. Around 70 percent of respondents were traditional payers; the remaining were provider-sponsored, third-party administrators, and management services organizations.”
  • According to Healthcare Dive,
    • “A merger between major health insurers Cigna and Humana would go through the wringer of an intense antitrust review, but could come out finalized, experts say.
    • “Though, to receive the regulatory green light, a combined company would probably have to emerge looking different from the Cigna and Humana of today. * * *
    • “Gaining regulatory approval — especially if a challenge further ties up the process in the courts — could set a deal’s finalization back by a year or more. But, due to a lack of direct competition between the two, Cigna and Humana could be allowed to combine, creating a healthcare powerhouse with roughly $300 billion in annual revenue.”
  • and
    • “For-profit hospital chain HCA Healthcare’s Houston affiliate announced last week it completed its acquisition of 11 free-standing emergency departments from SignatureCare Emergency Centers. 
    • “HCA Houston Healthcare, which operates a network of 13 hospitals and nine outpatient surgery centers, now has 26 free-standing emergency departments in the area in addition to hospital-based emergency rooms, according to a Friday press release.
    • “The SignatureCare centers will be re-branded to HCA Houston ER 24/7. Financial terms of the deal were not disclosed.
  • and
    • “Rural hospital chain Lifepoint Health and Ascension Saint Thomas announced a joint venture last week to co-own Highpoint Health, a four-hospital system in Tennessee currently operated by Brentwood, Tennessee-based Lifepoint.
    • “The hospitals and care sites will be co-branded with Ascension Saint Thomas, but will be majority-owned and operated by Lifepoint, according to the release. The companies declined to comment on the cost of the buy-in.
    • “The health systems have partnered before. Ascension Saint Thomas partnered with Kindred Rehabilitation Services, a Lifepoint business unit, in 2022 to jointly own Ascension Saint Thomas Rehabilitation Hospital in Nashville.” 

Weekend Update

From Washington, DC,

  • The Federal Benefits Open Season ends a week from tomorrow.
  • KFF News provides a helpful overview of the recently proposed Affordable Care Act notice of benefit and payment parameters.
  • The New York Times reports,
    • “A small group of Republican senators on Friday called on President Biden to ban travel from China to protect against an outbreak of respiratory illnesses in children there, even as scientists and global and American health officials said there were no signs of a threatening new pathogen.
    • “Instead, those experts said, the evidence so far pointed to a surge of age-old infectious agents such as influenza, driven by the colder weather and China’s emergence from stringent Covid lockdowns. The World Health Organization said last week that China had shared data about its outbreak, including laboratory results from infected children, that did not show any unusual pathogens.
    • “Dr. Mandy Cohen, the director of the Centers for Disease Control and Prevention, echoed that assessment on Friday. She said American officials had also been in touch with Chinese authorities, academic experts and health workers.
    • “What we have all been able to ascertain is that there is no novel pathogen,” she said. “This is all related to upticks of known viruses and bacteria in their pediatric population.”

From the public health front,

  • NPR Shots tells us,
    • “There’s just not much that’s very effective for treating the common cold,” said Dr. Lauren Eggert, clinical assistant professor in the Pulmonary Allergy and Critical Care Division at Stanford University. * * *
    • “She opens a database called UpToDate, which physicians use as a resource when they want to see the summary of evidence for medications targeting specific concerns. The conclusions for cold and flu remedies are disconcerting:
      • “Antihistamines, vitamins and herbal remedies are deemed ineffective.
      • “Cough syrups, decongestants, expectorants, and zinc may have minimal or uncertain benefits.
      • “Nasal sprays and analgesics like Tylenol and ibuprofen may be effective.”
  • The American Medical Association lets us know what doctors wish their patients knew about Covid oral anti-virals, Paxlovid and molnupiravir.
  • Medscape points out,
    • Breast cancer has a worse prognosis when diagnosed during pregnancy or postpartum. Methods for early detection are needed, as evidenced every day in the multidisciplinary unit for treating pregnancy-associated breast cancer, which operates within the Breast Unit at the Vall d’Hebron University Hospital in Barcelona, Spain.
    • “The team working in this field is led by Cristina Saura, PhD, who is also head of the Breast Cancer Group at the Vall d’Hebron Institute of Oncology (VHIO). The results of a study recently published in Cancer Discovery show, for the first time, that breast milk from breast cancer patients contains circulating tumor DNA (ctDNA) that can be detected by a liquid biopsy of the milk.”

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Yesterday, OPM’s Office of Inspector General posted its Semi-annual Report to Congress for September 30, 2023. OPM has not yet posted its Management Response thereto.
  • The HHS Office of Inspector General also issued its latest Semi-annual Report to Congress.
  • Federal News Network reports that federal employees in Japan continue to experience healthcare access problems.
  • The Director of HHS’s Agency for Healthcare Research and Quality explains how the Biden Administration is tackling financial strains on healthcare consumers.

From the public health and medical research front,

  • Beckers Clinical Leadership tells us,
    • “CDC Director Mandy Cohen, MD, said the season of respiratory syncytial virus is in “full swing” as flu slowly begins and COVID-19 leads the most hospitalizations and deaths, CNN reported Nov. 30. 
    • “What to know about COVID-19, RSV and flu:
      • COVID-19: Dr. Cohen said while COVID-19 is “relatively low,” it remains the primary reason for new respiratory admissions and deaths. In November, each week saw between 14,000 and 18,000 hospitalizations and about 1,000 deaths. 
        • “The CDC revealed a new wastewater data tracking dashboard to track local and national trends per variant, and the dashboard also tracks mpox viruses. 
        • “Between Nov. 1 and Nov. 20, the most recent CDC information available, the proportion of wastewater sites reporting high increases of SARS-CoV-2 samples grew from 22% to 32%. During the same time, the proportion of wastewater sites finding decreasing samples slimmed from 60% to 49%. 
      • RSV: “Hospitalizations for RSV have been slightly rising, with RSV accounting for 0.5% of all hospitalizations in late October and 0.8% as of Nov. 18, according to the CDC. Ten states and New York City are reporting high levels of respiratory virus activity. Louisiana and South Carolina reported “very high” respiratory virus activity levels and Alabama, California, Colorado, Florida, Georgia, Mississippi, New Mexico and Texas are seeing “high” levels.
      • Flu: “The flu season is beginning as national estimates reveal 3.9% of healthcare visits were for flu for the week ending Nov. 25, a 0.2 percentage point increase from the prior week.  Most of the U.S. is reporting an increase in flu, with hot spots appearing in the South Central, Southeast, Mountain and West Coast regions. Twenty-five states and territories are reporting minimal flu activity.
        • “Hospitalizations for flu have grown for the third consecutive week.” 
  • The Wall Street Journal reports,
    • “The Centers for Disease Control and Prevention is urging people to avoid eating certain cantaloupe products amid a salmonella outbreak that has resulted in at least two deaths in the U.S.
    • “At least 117 people across 34 states have become sick after eating contaminated cantaloupe since mid-October, according to the CDC. At least 61 people have been hospitalized and two have died in Minnesota. The federal agency said the number of people sickened by the outbreak is likely much higher.
    • “The agency said it’s particularly concerned about the outbreak because the illnesses have been severe and some have occurred in long-term-care facilities and child-care centers. Fourteen people in long-term-care facilities and seven children who attended child-care facilities have been sickened, the CDC said.”
  • STAT News informs us,
    • “Advances in treatments for congenital heart abnormalities mean more patients are living into adulthood, with over 2 million adults estimated to have the condition in the U.S. But that means more are also developing heart failure as they grow older — and many aren’t receiving proper care.
    • “A new study published this week in the Journal of the American Heart Association found that while hospitalizations of adults with congenital heart disease stayed stable from 2010 to 2020, the proportion of admissions for those who have heart failure more than doubled from 6.6% to 14%.
    • “These patients with heart failure also had worse outcomes after hospitalization, with an 86% higher risk of death, a 73% higher risk of major heart and brain complications, and a 26% higher risk of hospital readmission.
    • “The findings suggest that adults with congenital heart disease who also have heart failure are an especially high-risk population, and they may need closer monitoring and unique treatment regimens.”
  • Health Day offers these key takeaways from recent study results:
    • “Sticking to your scheduled mammograms can significantly reduce your risk of death from breast cancer
    • “Women who got all their scheduled mammograms had a 66% to 72% reduced risk of breast cancer death
    • “Regular mammograms make it more likely that breast cancers can be caught early, when they are more treatable.”
  • Mercer Consulting discusses why an end to HIV in our country is in sight and shares five ways to address HIV in the workplace.
  • The American Hospital Association News adds
    • “Nine out of 10 people receiving medical care for HIV through the Ryan White HIV/AIDS Program in 2022 were virally suppressed, meaning they cannot sexually transmit the virus if they take their HIV medication as prescribed, according to the latest annual data from the Health Resources and Services Administration program.”

From the U.S. healthcare business front,

  • EBRI posted Fast Facts about the changing nature of primary care in our country.
    • “Among users of primary care, 95–97 percent utilized it in an office setting prior to 2020, but only 86 percent did so from 2020–2021 as employees began using telemedicine (7–8 percent) and urgent care clinics (3–4 percent) with greater frequency due to the COVID-19 pandemic.
    • “There has been a consistent downward trend in the share of employees whose primary care office visits are at a general/family practice, falling from 42 percent in 2013 to 37 percent in 2021. In addition, primary care office visits at internal medicine providers have fallen from 21 percent in 2013 to 17 percent in 2021.
    • “Finally, the provision of primary care by a medical doctor has fallen from 9 percent in 2013 to 4 percent in 2021. In contrast, primary are provision by nurse practitioners and physician assistants has risen over time. The share of employees whose primary care office visits have been with a physician assistant rose from 2 percent in 2013 to 6 percent in 2021.
    • “The corresponding change for nurse practitioners has been from 4 percent in 2013 to 16 percent in 2021.”
  • BioPharma Dive lets us know,
    • “Pfizer will not advance a twice-daily dose of an experimental obesity drug into further testing after results from a mid-stage study showed high rates of gastrointestinal side effects and participant dropout. 
    • “Treatment did lead to significant weight loss compared to placebo over the course of the Phase 2b study. Placebo-adjusted reductions in body weight ranged from 8% to 13% at 32 weeks, Pfizer said in a statement Friday. Discontinuation rates were more than 50% on some drug doses, however.
    • “Moving forward, Pfizer will turn its focus to a once-daily version that’s currently being tested in a study meant to determine how the drug’s processed by the body. Data are expected in the first half of next year.”
  • Healthcare Dive reports,
    • “Community Health Systems announced on Friday it has completed the sale of three Florida hospitals to Tampa General Hospital for about $294 million in cash.
    • “The deal includes 120-bed Bravera Health Brooksville, 124-bed Bravera Health Spring Hill and 128-bed Bravera Health Seven Rivers, as well as their associated assets, physician clinic operations and outpatient services, according to a press release.
    • “The sale allows the for-profit hospital operator to “deliberately focus our resources in markets that we deem as most investable and that can produce greater growth and returns over the long term,” CHS CEO Tim Hingtgen said during a call with investors shortly after the divestiture was announced this summer.” 
  • MedCity News explains how payers can break down barriers that prevent access to value-based virtual care.
  • Per Fierce Healthcare,
    • Daniel Jones, who pens the investment newsletter Crude Value Insights, wrote in an analysis that because Cigna and Humana have fairly different focuses despite both being large health plans, there is potential that the merger could be viewed as more of a vertical deal than a horizontal one, which is less likely to stymie competition.
    • Cigna is a far smaller player in the Medicare Advantage space while Humana’s insurance business is overwhelmingly centered in MA. Humana, meanwhile, has limited reach in the commercial market, where Cigna has a far greater footprint.
  • Beckers Payer Issues adds,
    • “The sale of Cigna’s Medicare Advantage business would remove one hurdle in the company’s reported goal to merge with Humana, and Health Care Service Corp. might be part of that equation, Bloomberg reported Nov. 29.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC,

  • Govexec tells us,
    • “A House panel on Wednesday hosted another spirited hearing over the role of telework and remote work at federal agencies, with Democrats and agency officials extolling the practices’ impact in improving productivity to skeptical GOP lawmakers.
    • “The House Oversight and Accountability Committee’s subcommittee on government operations and the federal workforce held its long-awaited second hearing on federal agencies’ “post-pandemic” telework policies. In September, the subcommittee heard testimony from HR leaders at agencies that made a “good faith effort” to comply with the panel’s information requests on telework, and Republican committee leaders suggested Wednesday’s hearing was designed to hear from agencies whose submissions were found wanting.
    • “It is difficult for me to understand why [these agencies’] responses looked like nothing more than them phoning it in,” said Subcommittee Chairman Pete Sessions, R-Texas. “This is a serious effort by the subcommittee. It has produced questions across both sides of the aisle. Either these agencies simply do not know the answers to some or all of the questions asked, or perhaps they just don’t want to share it.”
  • The American Hospital News reports,
    • The Departments of Health and Human Services, Labor and the Treasury will give healthcare providers and insurers initiating a payment dispute through Jan. 16 under the No Surprises Act’s Independent Dispute Resolution process 10 business days to select a certified IDR entity after initiating the dispute, the Centers for Medicare & Medicaid Services announced Nov 29. 
    • “Following the reopening of the Federal IDR portal on October 6, 2023, to certain new single disputes, including disputes involving bundled payment arrangements, but excluding disputes related to air ambulance services, the Departments extended the certified IDR entity selection timeline to 10 business days until November 3, 2023,” CMS explained. “Following the expiration of that extension and the return to the three-business-day timeline, numerous disputing parties have requested that the timeline temporarily return to 10 business days. Accordingly, the Departments are announcing that disputing parties will have 10 business days to select a certified IDR entity for all disputes through January 16, 2024. This extension will be provided automatically and does not require a request by disputing parties.”
  • The U.S. Preventive Services Task Force released for public comment a draft research plan for assessing the value of screening for HIV. The public comment period ends on January 3, 2024.

In FEHB Open Season news, Tammy Flanagan, writing in Govexec, discusses the Medicare Advantage plans that may FEHB carriers have integrated into their FEHB plans.

From the public health and medical research front,

  • The New York Times looks back at the Omicron variant of Covid which has been with us for two years now. While the earlier commanding Covid variants caused dangerous lower respiratory infections, Omicron causes more manageable upper respiratory infections.
  • Medscape informs us about encouraging developments that may lead to long Covid tests.
    • “[A] new preprint study suggests that the elevation of certain immune system proteins are a commonality in long COVID patients and identifying them may be an accurate way to diagnose the condition.
    • “Researchers at Cardiff University School of Medicine in Cardiff, Wales, United Kingdom, tracked 166 patients, 79 of whom had been diagnosed with long COVID and 87 who had not. All participants had recovered from a severe bout of acute COVID-19.”
  • STAT News reports,
    • “The rosiest of revenue projections for treatments like Wegovy and Zepbound rely on a future in which their use goes beyond diabetes and obesity and into Alzheimer’s disease and substance use disorders. But GLP-1 drugs’ pathway to pharmaceutical ubiquity is a little cloudier than it might seem.
    • “Take for example alcohol use disorder, or AUD. This week, a case study published in the Journal of Clinical Psychiatry reported that six patients diagnosed with AUD received Wegovy for weight loss and experienced significant reductions in their symptoms, sparking more interest in the potential of GLP-1 treatments in addiction. According to Leerink analyst David Risinger, there are at least six other mid-stage studies testing whether Novo Nordisk’s drug can treat AUD or nicotine dependence, each reading out in the coming years.
    • “The problem is that not one of those studies is sponsored by Novo, which has been noncommittal about running the costly, large-scale trials that would be required to win FDA approval in addiction. Physicians could prescribe a GLP-1 drug off-label, but manufacturers are already struggling to meet demand for patients with diabetes or obesity, leaving little supply for speculative indications.”
  • MedPage Today points out,
    • “Younger onset age of coronary heart disease was tied to higher risks of incident all-cause dementia, Alzheimer’s disease, and vascular dementia, a large prospective cohort study in Great Britain showed.
    • “Each 10-year decrease in coronary heart disease onset age was associated with a 25% increased risk of all-cause dementia, a 29% increased risk of Alzheimer’s disease, and a 22% increased risk of vascular dementia (all P<0.001), reported Fanfan Zheng, PhD, of the Chinese Academy of Medical Sciences and Peking Union Medical College in Beijing, and co-authors in the Journal of the American Heart Association.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “The United States faces a serious shortage of primary care physicians for many reasons, but one, in particular, is inescapable: compensation.
    • “Substantial disparities between what primary care physicians earn relative to specialists like orthopedists and cardiologists can weigh into medical students’ decisions about which field to choose. Plus, the system that Medicare and other health plans use to pay doctors generally places more value on doing procedures like replacing a knee or inserting a stent than on delivering the whole-person, long-term healthcare management that primary care physicians provide.
    • “As a result of those pay disparities, and the punishing workload typically faced by primary care physicians, more new doctors are becoming specialists, often leaving patients with fewer choices for primary care.
    • “There is a public out there that is dissatisfied with the lack of access to a routine source of care,” said Christopher Koller, president of the Milbank Memorial Fund, a foundation that focuses on improving population health and health equity. “That’s not going to be addressed until we pay for it.”
  • and
    • “Renton, Washington-based Providence’s operations tallied $310 million of net losses (-4.3% operating margin) during the third quarter and now sit $857.3 million in the hole (-4% operating margin) through nine months, according to filings and other financial information released this week by the nonprofit.
    • “Providence’s leadership was quick to highlight the system’s performance improvements relative to 2022, when the Catholic organization had posted a nearly $1.1 billion operating loss (-5.6% operating margin) across nine months.
    • “Rising demand, reduced length of stay, lower premium pay and better workforce retention and recruitment each helped Providence chip away at the losses, the organization wrote in an accompanying release, though lingering expense pressures and revenue roadblocks still held operations below break even.”
  • and
    • “The Cleveland Clinic logged another negative operating margin and nine figures of net losses during the three months ended Sept. 30, according to unaudited financial statements released this week.
    • “The nonprofit reported a $14.9 million operating loss (-0.4% operating margin) for the third quarter of 2023.
    • “This was an improvement over the same period in 2022, when the system logged a $28.3 million operating loss (-0.9% operating margin), and a narrow increase over the $21.4 million operating loss (-0.6% operating margin) of the immediately preceding quarter.
    • “In commentary accompanying the results, Cleveland Clinic’s management highlighted a 10.1% year-over-year rise in third-quarter operating revenue that outpaced the 9.6% bump in operating expenses.”
  • Beckers Payer Issues notes,
    • “Blue Cross Blue Shield of Arizona is looking to the payer-provider example set by Kaiser Permanente as the Phoenix-based company expands its primary care subsidiary Prosano Health Solutions, the Phoenix Business Journal reported Nov. 20.
    • “BCBSAZ opened its first Prosano facility in Maricopa County this year, with several more locations opening in the Phoenix area in 2024. Prosano launched in January for BCBSAZ employees, with 1,800 employees and their dependents enrolling. 
    • “A new health plan, the BlueSignature Prosano PPO plan, will be offered to employer groups in 2024 and provide access to the Prosano care centers. The new care centers offer access to a primary care team, behavioral health practitioners, lab services, same-day appointments, virtual options, and a selection of the most needed prescriptions. An expansion to Tucson is planned for 2025.”
  • MedPage lets us know,
    • “Optum Health now counts 90,000 doctors — some 10% of the physician workforce — as employees or affiliates, company leadership announced.
    • “The company, which is a part of UnitedHealth Group, said during an investor conference on Wednesday that it acquired or hired nearly 20,000 doctors in 2023 alone, according to reports. It also counts an additional 40,000 advanced practice clinicians among its ranks.
    • “The figures, reported by Amar Desai, MD, CEO of UnitedHealth’s Optum Health division, make Optum Health the largest employer of physicians in the U.S., and UnitedHealth is the country’s largest private health insurer.”
  • STAT News reports,
    • “AbbVie will pay $10 billion for the biotech firm Immunogen, the company said Thursday, acquiring an approved treatment for ovarian cancer and buying into a burgeoning area of oncology.
    • “Under the agreement, AbbVie will pay $31.26 per share in cash for Immunogen, a nearly 100% premium to the company’s recent trading price. Central to the deal, expected to close in the middle of next year, is Elahere, an Immunogen product that won Food and Drug Administration approval for advanced ovarian cancer in 2022.
    • “Elahere is among a surging class of cancer medicines called antibody-drug conjugates, or ADCs, which are designed to deliver a targeted dose of chemotherapy directly to tumor cells while sparing healthy tissues. AbbVie’s acquisition is the latest multibillion-dollar deal in the space, following Merck’s $22 billion agreement with ADC specialist Daiichi Sankyo and Pfizer’s $43 billion buyout of Seagen earlier this year.”

Midweek Update

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

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.”

Happy Thanksgiving!

Following this post, The FEHBlog will reappear on Saturday for Cybersecurity Saturday. The FEHBlog wishes his readers a Happy Thanksgiving.

From Washington DC

  • Thanks to Bloomberg, the FEHBlog learned about this Congressional Research Service report on FY 2024 USPS Appropriations. To wit,
    • “On September 30, 2023, Congress passed the Continuing Appropriations Act, 2024 and Other Extensions Act (H.R. 5860; P.L. 118-15), which provides continuing FY2024 appropriations to federal agencies through November 17,
    • “Section 126 of the act increases the rate of funding for the Office of Personnel Management (OPM) to approximately $219.1 million, which is about $28.3 million above its FY2023 funding.
    • “The additional OPM funding is provided for the implementation of the Postal Service Health Benefits Program (PSHBP), a new health benefit program for eligible postal employees and retirees. Under the PSRA, OPM is required to establish and administer the PSHBP.”
  • FEHBlog note — The Postal Service also is on the financial hook for funding implementation of the PSHBP.
  • STAT News reports,
    • “Senate Democrats, led by Sen. Bernie Sanders (I-Vt.), on Tuesday mounted a public pressure campaign to get the executives of Merck, Johnson & Johnson, and Bristol Myers Squibb to testify in a January hearing on why the United States pays more for prescription drugs than other countries.
    • “All three companies have sued the Biden administration over the new Medicare drug price negotiation that congressional Democrats passed last year. Bristol Myers Squibb’s blood thinner Eliquis; Johnson & Johnson’s blood thinner Xarelto, anti-inflammatory medicine Stelara, and blood cancer treatment Imbruvica; and Merck’s diabetes drug Januvia were selected as part of the first 10 drugs to go through the negotiation process.
    • “It’s unclear whether the executives will agree to testify at the hearing, which is titled “Why “Does the United States Pay, By Far, The Highest Prices In The World For Prescription Drugs?” Sanders also put out a fundraising email just before the letter was announced, with the subject line: “The greed of the pharmaceutical industry is out of control.” It featured an op-ed he wrote for the Guardian Monday.”

In FEHB Open Season and federal retirement news,

  • Fedweek provides Reg Jones’ observations on FEHBP and Medicare Parts A and B. The Federal Times offers articles titled “A Procrastinator’s Checklist for Choosing Open Season Benefits” and “What’s driving rate hikes for federal employee health premiums?
  • The second Federal Times article is a topic that the FEHBlog follows throughout the year. In that regard, Mercer Consulting released the following survey findings last week:
    • “Mercer, a business of Marsh McLennan (NYSE: MMC), released the findings of its 2023 National Survey of Employer-Sponsored Health Plans, which found the average per-employee cost of employer-sponsored health insurance rose by 5.2% in 2023 to reach $15,797. * * *
    • “In 2022, cost rose by 3.2%, well below general inflation, which averaged 8% that year. Because healthcare providers typically have multi-year contracts with health plans, employers did not feel the full brunt of inflation last year. “Rather, inflation-driven cost increases are phasing in as contracts are renewed,” says Sunit Patel, Chief Health Actuary, Mercer. The survey shows employers project another sharp increase of 5.2% for 2024.
    • “It may take another couple of years for price increases stemming from higher healthcare sector wages and medical supply costs to be felt across all health plans,” Mr. Patel says.
    • “At the same time, inflation is only one factor behind this year’s higher cost increases. In 2023, spending on prescription drugs rose sharply. “While the effects of inflation may be relatively short-lived, new and ongoing developments in the pharmaceutical market seem likely to have a longer-term impact on health benefit cost.”
  • The Federal Times adds,
    • “Federal employees’ retirement applications take almost twice as long to process when they contain errors, leading to further delays in processing and dispensing annuities, according to a watchdog report published Monday.
    • “The Office of Personnel Management’s inspector general found that “healthy” application packages took on average 53 days to process, and “unhealthy” ones containing errors took more than 108 days, according to a random sample of applications the inspector general studied.
    • “That discrepancy needs be reflected in the data OPM reports monthly to accurately monitor whether retirement processing is improving, the IG report said.
    • “The lack of transparency for healthy versus unhealthy ‘incomplete’ application packages limits the quality of information being provided to external parties as the main cause for why Retirement Services has not met its goal for processing retirement application packages within 60 days,” according to the report.”

From the public health and medical research front,

  • Beckers Clinical Leadership tells us,
    • “Hospital and public health officials are urging people to take precautions and be mindful of where they seek care to limit capacity strain on emergency departments as respiratory virus activity heats up heading into the holiday season. 
    • “Since early September, COVID-19 metrics had mostly been trending downward or remained flat. Now they are on the rise again, though they remain far below levels seen in previous surges. There were 16,239 new admissions for the week ending Nov. 11, up 8.6% from the previous week. 
    • “Meanwhile, most of the country is seeing an uptick of flu and respiratory syncytial virus cases. Hospitalizations associated with the two infections are also ticking up, particularly among children and older adults. 
    • “The more concerning thing is the severity of some of the illness,” Hany Atallah, MD, chief medical officer Jackson Memorial Hospital in Miami, told ABC affiliate WPLG. “And we are also seeing some patients come in with more than one viral infection, so they may have RSV and flu, for example. We’re constantly trying to follow the science and encourage people to get vaccines.” 
  • The Wall Street Journal points out,
    • “Ozempic, Wegovy and their counterparts have exploded in popularity over the past year, earning billions for the drugs’ makers, transforming the American approach to weight-loss, and sparking widespread cultural discussion in a country that is already obsessed with weight
    • “That conversation lands on Thanksgiving tables this week, where some people say the drugs have boosted their confidence around food, and others say they are worried about facing questions about what they’re eating, what they’re not eating, and changes in their appearance.
    • “It’s a hot topic, and people have a lot of judgments,” says Dr. Gauri Khurana, a psychiatrist in private practice in New York City and a clinical instructor at Yale University who has prescribed the medications and helped patients manage them. * * *
    • “Doctors advise people to listen to their bodies—not their family members—when it comes to serving sizes. A balanced plate that gives priority to protein and high-fiber foods over carbohydrates and fatty foods, which tend to sit in the stomach and exacerbate the medication’s effects of delayed gastric emptying, can help patients avoid filling up too quickly or feeling nauseous.”
  • The New York Times reports,
    • “Just in time for the holiday season, the Biden administration is offering Americans a fresh round of free at-home coronavirus tests through the Postal Service.
    • “The administration revived the dormant program in September, announcing then that households could order four free tests through a federal website, covidtests.gov.
    • “Beginning Monday, households may order an additional four tests. Households that have not placed an order since the program resumed can submit two orders, for eight tests in total.”
  • The University of Minnesota informs us,
    • “A new survey of 158 hospital executives, conducted by the Sepsis Alliance, found that 90% see antimicrobial resistance (AMR) as a threat, and 88% think the problem is getting worse. The survey, conducted by Sage Growth Partners on behalf of the Sepsis Alliance, also dug into executives’ views on other related AMR issues. An 11-page report on the findings was published on the Sepsis Alliance websiteon November 17.
    • “Another top concern is the public’s lack of knowledge about AMR, with 59% of executives saying that public education of clinicians as well as patients is the largest barrier to antibiotic stewardship. Respondents recommend public service announcements covering the need for early treatment, the importance of completing treatment, and storing the drugs properly.”

From the U.S. healthcare business front,

  • Healthcare Dive asks “Where are all the nurses? Hospitals, advocates disagree on crisis; Hospitals and nursing unions disagree about what’s driving sluggish application rates for open registered nurse positions — a lack of qualified candidates or a lack of interest.”
  • BioPharma Dive notes,
    • “Roche’s Genentech unit is partnering with computing giant Nvidia in a multiyear deal that highlights the pharmaceutical industry’s growing hopes of using artificial intelligence to speed up the process of designing and developing new drugs. 
    • “By collaborating with Nvidia, Genentech expects to “significantly enhance” its existing AI research and potentially improve on the chip designer’s own software, such as its “BioNemo” platform for drug discovery. 
    • “Our teams will be continuously exchanging expertise on the advancement of science and the state-of-the-art methods emerging in accelerated computing, AI and simulation across this entire drug discovery process,” said Kimberly Powell, vice president of healthcare at Nvidia, in a briefing with reporters.”