Midweek Update

Federal employment benefits

Midweek Update

David Ermer–CDC, COVID-19, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC

  • Govexec informs us,
    • “A new website has made available a database of anyone serving in a top-ranking position in the federal government, offering new insight that advocates said will boost transparency and better prepare new administrations to transition into power.  
    • “The Office of Personnel Management launched the site to comply with the Periodically Listing Updates to Management (PLUM) Act, which so far includes the names, roles and pay levels of more than 8,000 executives in government.
    • “OPM said that figure will grow to 10,000 as it ensures compliance and updates the list over the coming months. It will include senior leaders at every federal agency, including all 4,000 political appointees, Senior Executive Service members and other top or non-competitively appointed officials. “
  • The Department of Health and Human Services tells us,
    • On Wednesday, January 3, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra met virtually with long-term care facility (LTCF) leaders to express concerns about low vaccination rates among nursing home residents and remind industry leaders of their obligations to offer the COVID-19 vaccine to residents and staff.
    • Today’s conversation was a follow-up call from a previous HHS virtual meeting on December 21 with LTCF leaders to discuss the Centers for Disease Control and Prevention’s (CDC) December 2023 report finding that just 33% of long-term care facility residents were up to date with their COVID-19 vaccinations. The Centers for Medicare & Medicaid Services (CMS) requires all nursing homes to offer COVID-19 vaccines to residents and staff and educate them on their benefits.
  • FedWeek notes,
    • “Fraud against the federal retirement program is continuing, an inspector general report has said, with lack of reporting to OPM on the deaths of beneficiaries the most common means.
    • “These unreported deaths may allow payments to continue because of program vulnerabilities or intentional fraud on the part of bad actors. Sometimes, CSRS or FERS improper payments continue for years and cost tens of thousands of dollars before discovery,” says the IG’s latest summary of its investigative activities.”
  • FEHBlog note — The government needs a better system to keep track of deaths.

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

  • The New York Times reports,
    • “The holidays have come and gone, and once again Americans are riding a tide of respiratory ailments, including Covid. But so far, this winter’s Covid uptick seems less deadly than last year’s, and much less so than in 2022, when the Omicron surge ground the nation to a halt.
    • “We’re not seeing the signs that would make me think that we’re heading into another severe wave,” said Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. “So far, we’re in relatively good shape.”
    • “Still, * * * just a fraction of the most vulnerable people have received the latest Covid shots, she noted.
    • “It’s not too late,” Dr. Rivers added. “We have not even reached peak yet for Covid, and once you reach peak, you still have to get down the other side.” That leaves plenty of time for the vaccine to provide some protection.”
  • Beckers Hospital Review adds,
    • “COVID-19 and flu admissions continue to climb across the country, with the majority of states now reporting high levels of respiratory virus activity. 
    • “Overall, 31 states reported high levels of respiratory virus activity for the week ending Dec. 23. Included in this total are a growing number of states seeing “very high” activity levels: Alabama, California, Colorado, Georgia, Louisiana, Mississippi, Nevada, New Jersey, New Mexico, North Carolina, South Carolina, Tennessee, Virginia and New York City. Two weeks ago, just five states reported very high levels.” 
  • Medscape notes
    • “While COVID has now claimed more than 1 million lives in the United States alone, these aren’t the only fatalities caused at least in part by the virus. A small but growing number of Americans are surviving acute infections only to succumb months later to the lingering health problems caused by long COVID.
    • “Much of the attention on long COVID has centered on the sometimes debilitating symptoms that strike people with the condition, with no formal diagnostic tests or standard treatments available, and the effect it has on quality of life. But new figures from the US Centers for Disease Control and Prevention (CDC) show that long COVID can also be deadly.
    • “More than 5000 Americans have died from long COVID since the start of the pandemic, according to new estimates from the CDC.”
  • STAT News alerts us,
    • “One in three heart patients live with anxiety, depression, and ongoing stress, according to a 2023 meta-analysis of over 100 studies. But even in the age of 24/7 monitoring via implantable loop recorders and wearables, many patients are without professional support for the mental and emotional social aspects of coping with heart disease.
    • “The technology of cardiology is locked down. People get that. What’s not locked down is the patient experience,” said Sam Sears, professor of health psychology at East Carolina University, and the author of over 200 research studies on psychological interventions for heart health. “The human factors in all this just don’t get addressed as a standard of care.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cigna is in advanced talks to sell its Medicare business in an about-face for the health-insurance giant, which had been expanding its footprint in the fast-growing sector. 
    • “Cigna, which has been running an auction for the business, known as Medicare Advantage, is now in exclusive talks to sell it to Health Care Service Corp. for between $3 billion and $4 billion, according to people familiar with the matter. 
    • “Should there be a deal, it would mark a major expansion for HCSC, a big nonprofit health insurer that is the parent of Blue Cross Blue Shield plans in five states including Texas and Illinois. HCSC has long been a powerful player in its home states, but the deal would give it a significant Medicare business and far broader reach. Cigna is offering Medicare plans in 29 states for 2024.
  • Drug Channels offers its annual “reality check on U.S. drug pricing.”
  • Per Fierce Healthcare,
    • “Solera Health, a chronic condition management platform for payers and employers, is expanding its platform to include virtual specialty care facilitated by several new clinical partners.
    • “Solera’s HALO Platform is an omni-condition management tool that aims to address high-cost chronic conditions, mostly serving commercial populations. The latest expansion into virtual specialty care furthers the company’s value-based care mission by widening access to specialist docs in a low-cost setting, executives told Fierce Healthcare.
    • “The new capabilities leverage partnerships with two new partners, 9am.health and Vori Health, as well as an existing partner, Oshi Health.
    • “Each partner specializes in addressing high-cost conditions, from obesity and diabetes to musculoskeletal pain to GI conditions. They offer a health coach, nutritionist, peer support and other support services while also coordinating with a patient’s primary or in-person care doc.”
  • Health Payer Intelligence looks at employer-sponsored plan trends for 2024.

Tuesday Tidbits

David Ermer–FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The U.S. Census Bureau informs us,
    • “[T]he U.S. population [was projected to be] 335,893,238 on New Year’s Day, an annual increase of 1,759,535 or 0.53%.
    • “In January 2024, the United States is expected to experience a birth every 9.0 seconds and one death every 9.5 seconds. Meanwhile, net international migration is expected to add one person to the U.S. population every 28.3 seconds. The combination of births, deaths and net international migration increases the U.S. population by one person every 24.2 seconds.
    • “The projected world population on Jan. 1, 2024, is 8,019,876,189, up 75,162,541 (0.95%) from New Year’s Day 2023. During January 2024, 4.3 births and 2.0 deaths are expected worldwide every second.”
  • The Internal Revenue Service released the Employers’ Tax Guide to Fringe Benefits for use in 2024.
  • Federal News Network discusses four ways federal pay practices have changed for 2024.
  • The Food and Drug Administration accounts for its recent actions.

From the public health and medical research front,

  • Medscape explains the other health conditions, besides diabetes and obesity, that GLP-1 drugs might treat. It’s an impressive list.
  • STAT News reports,
    • “Reducing or eliminating alcohol consumption reduces the risk of developing oral cavity and esophagus cancers, according to a special report from the International Agency for Research on Cancer. But more data are needed to conclude whether the same is true for several other cancer types, including colorectal, breast, and liver cancer.
    • “Even so, it is likely that reducing or ceasing to drink alcohol will lessen the risk of these cancers, said Farhad Islami, a cancer epidemiologist at the American Cancer Society and an author of the report. “Given that many of these cancers have similar mechanistic pathways, we think we will see a similar association with reduction or cessation,” he said. “That’s why we recommend more studies, so we can have stronger evidence.”
  • BioPharma Dive points out ten clinical trials that are worth watching in the first half of 2024.

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “BJC HealthCare and Saint Luke’s Health System closed their merger on Monday, about seven months after the Missouri-based systems announced plans to combine.The combined organization will operate under the BJC HealthCare brand in its eastern region, serving St. Louis and southern Illinois. The Kansas City region will retain the Saint Luke’s brand name. The new system has a combined workforce of 44,000 employees, according to a Tuesday announcement.”
  • MedTech Dive notes,
    • “Roche reached an agreement to acquire LumiraDx’s point-of-care testing technology, the companies announced on Dec. 29.
    • “Roche will pay $295 million upfront and an additional amount up to $55 million to fund Lumira’s point-of-care technology platform business until the acquisition closes. 
    • “The acquisition comes as Lumira faces a potential delisting amid declining revenue.”
  • Health Payer Intelligence identifies trends in health insurer strategies for 2024. “In 2024, payer strategies will include improving health equity partnerships, differentiating their Medicare Advantage plans, and offering care navigation.”
  • Healthcare IT News offers an interview with “[t]wo investment bankers discuss the players in the telehealth sector, the main financial backers, the dynamics between venture capital and private equity, and more.
  • Beckers Hospital Review tells us,
    • “Feeling blue? Your employer might have an AI app for that, The Wall Street Journal reported Dec. 27. 
    • “Workplaces increasingly are offering employees access to digital mental health tools, including AI chatbots meant to mimic therapists and wellness apps that diagnose mental health conditions, the report said. Over the summer, a survey of 457 U.S. companies conducted by professional services company WTW found that about one-third offer a “digital therapeutic” for mental health support. Another 15% were considering adding one by 2025. 
    • “The capabilities and goals of these services vary. Amazon gives employees free access to the app Twill, which uses AI to track users’ moods and create “personalized mental-health plan(s).” A construction workers’ union in Ohio will begin offering access to Wysa, a self-described “emotionally intelligent” AI chatbot that encourages users to “vent or just talk through negative thoughts and emotions” and “let it help you cope with pandemic anxiety and lockdowns.” 

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Medical / Rx research, No Surprises Act, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec informs us,
    • “President Biden on Thursday issued an executive order implementing his plan to provide civilian federal workers with an average 5.2% pay raise next month.
    • “As first proposed in his fiscal 2024 budget plan last March, the increase amounts to a 4.7% across-the-board boost to basic pay, alongside an average 0.5% increase in locality pay. As authorized in the fiscal 2024 National Defense Authorization Act, which Biden is expected to sign this week, military service personnel also will see an average 5.2% pay raise next year.
    • “An average 5.2% pay increase marks the largest authorized for federal workers since the Carter administration adopted a 9.1% average raise in 1980, as well as a 0.6% increase over last year’s raise, which itself marked a 20-year high.”
  • STAT News reports
    • “Lawmakers are facing down a Jan. 19 deadline to renew a variety of expiring health care programs, so they just tucked away an extra $1.8 billion in a Medicare reserve fund in the NDAA, a Senate aide confirmed. They achieved the savings by extending the Medicare sequester’s end date, and then used some of the funds to pay for World Trade Center Health Program policies to support 9/11 survivors and first responders.
    • “The additional savings went to the Medicare piggy bank, formally known as the Medicare Improvement Fund, referred to in wonky circles as the MIF. Lawmakers will be able to pull from the MIF early next year as they weigh how to fund community health centers and stave off pay cuts to safety-net hospitals. It’s not a fortune, but it’s also nothing to sneeze at, given hospitals are panicked about the prospect of a payment policy passing that would save the federal government $3.7 billion over the next decade. It also gives them some wiggle room if they need to do another short-term extension of the programs.”
  • The American Hospital Association News relates,
    • “The Departments of Health and Human Services, Labor and Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types. Given the significant backlog resulting from the suspension of operations, the agencies today further extended the deadlines to March 14, 2024, for any IDR deadlines that fell in the suspension timeframe of Aug. 3 through Dec. 14, 2023, or currently have an initiation deadline between Dec. 15, 2023, and March 13, 2024. CMS announced extensions for additional dispute processes, including additional response time for requests for information, extension requests for offer submissions, and additional time to select a certified IDR entity for disputes.”
  • A bipartisan group of Senators sent a letter to the ACA regulators telling them
    • “We are writing in support of the recent decision from the U.S. District Court for the District of Columbia that vacated the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule provision that permitted the use of copay accumulator adjustment programs (AAPs) and remanded to the U.S. Department of Health and Human Services (HHS) to interpret the definition of “cost-sharing.” * * *
    • We are disappointed in HHS’s decision to file a notice of appeal of the decision and HHS’s articulated intention to not take any enforcement action against health insurance issuers or health plans that fail to count copay assistance toward the patient’s maximum annual limitation on cost-sharing. Instead of appealing the court’s ruling, we urge you to adopt policies from the 2020 NBPP that strike the right balance of preserving a plan’s ability to control costs while also putting the patient first.”
  • The 2020 NBPP permitted copay accumulators as long as State law did not object. “To date, 19 states, the District of Columbia, and Puerto Rico have banned or limited the use of copay accumulators.
  • Bloomberg reports,
    • “Some of the largest US hospital chains and most prestigious academic medical centers have violated federal rules by not posting the prices they charge for care, according to records obtained by Bloomberg News.
    • “For-profit HCA Healthcare Inc., the nation’s largest hospital system, and big nonprofit operators including Ascension and Trinity Health have been cited for failing to make prices fully available to the public, enforcement letters Bloomberg obtained through a public records request show. So have marquee facilities such as New York Presbyterian Weill Cornell Medical Center, Emory University Hospital and the Hospital of the University of Pennsylvania.
    • “The records reveal the challenges US regulators face as they try to force long-hidden prices into the open to address decades of rising medical expenses. Since 2021, hospitals have been required to be more transparent about what they charge. However, government data show that among 1,750 hospitals regulators evaluated as of early December, about 1,300 facilities — nearly 20% of the hospitals in the US — have been warned they violated rules. 
    • “Most corrected errors after they were pointed out, and officials charged with enforcing the rules say they’ve seen more hospitals complying. Regulators are also working to make the price data more useful.”
  • The U.S. Preventive Services Task Force released a final research plan for prostate cancer screening. Its most recent March 2018 recommendation fell below the A or B level grades required for no-cost coverage when provided in-network. The next stage will be a proposed 2024 recommendation.
    • “The Task Force keeps recommendations as current as possible by routinely updating existing recommendations and developing new recommendations. A multistep process is followed for each recommendation. The Task Force uses gold standard methods to review the evidence and is transparent at each step of the recommendation development process.”

From the public health and medical research front,

  • HR Dive relates,
    • “Physical health in the U.S. has worsened since the onset of the COVID-19 pandemic, a shift that could have detrimental effects on employers, according to Gallup survey results released Dec. 14. 
    • “Both obesity and diabetes are on the rise, Gallup found. The percentage of U.S. adults Gallup determined to have diabetes is 38.4%, up 6 percentage points from 2019 and a hair behind the record high 39.9% recorded last year. The number of respondents who said they have diabetes hit a new high of 13.6%, an increase of 1.1 points since 2019, per Gallup. 
    • “These health effects have practical implications for the U.S. economy. After controlling for factors such as age, income and education, workers with poor physical health — and poor wellbeing generally — suffer greatly enhanced levels of unplanned absenteeism and healthcare utilization (and associated costs) than do their counterparts,” Dan Witters, research director of the Gallup National Health and Well-Being Index, said.”
  • Per Medscape,
    • “A new frontier of brain-based therapies — from GLP-1 agonist drugs thought to act on reward and appetite centers to deep brain stimulation aimed at resetting neural circuits — has kindled hope among [obese] patients like Smith and the doctors who treat them. The treatments, and theories behind them, are not without controversy. They’re expensive, have side effects, and, critics contend, pull focus from diet and exercise. 
    • “But most agree that in the battle against obesity, one crucial organ has been overlooked.
    • “Obesity, in almost all circumstances, is most likely a disorder of the brain,” said Casey Halpern, MD, an associate professor of neurosurgery at the University of Pennsylvania. “What these individuals need is not simply more willpower, but the therapeutic equivalent of an electrician that can make right these connections inside their brain.”
  • The Wall Street Journal similarly reports,
    • “What if the best way to treat your chronic back pain is by retraining your brain?
    • “That’s the premise of a novel approach to chronic pain. Many people feel pain even after a physical injury has healed or when doctors can’t find a physical cause. The approach, called “pain reprocessing therapy,” tries to train the brain not to send false pain signals. Some early results are promising.
    • “In a study published last year in JAMA Psychiatry, 66% of a group of people who did the therapy for a month were pain-free or nearly pain-free up to a year later.
    • “The treatment is still largely in the research stages and typically not covered by insurance, but is being performed in a growing number of centers, including the VA Eastern Colorado Health Care System, which plans to start two clinical trials of the technique next year.” 
  • The American Hospital Association News reports,
    • “A CDC study released Dec. 21 found low COVID-19 and flu vaccination coverage for most adults, and low RSV vaccination coverage for adults aged 60 and older. Antiviral treatments are also being underused, and COVID-19 rebound can happen whether patients receive any, the study said. Among other findings, the report said that most nursing home residents have not received an updated COVID-19 vaccine or RSV vaccine for residents aged 60 and older using shared clinical decision-making.”
  • Unfortunately, Patient Engagement HIT points out,
    • “Few Providers Use [ICD-10] Z-Codes to Document Social Determinants of Health.
    • “Use of Z-codes to document social determinants of health is low, and there are differences in which patients get a Z-code documented, two unrelated studies showed.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “The labor outlook is stabilizing for U.S. nonprofit hospitals as employment increases and healthcare job openings decline, according toa new report from Fitch Ratings. 
    • “Hospital and ambulatory healthcare services payrolls have risen for 22 and 34 consecutive months respectively, according to the credit ratings agency. Wage growth has remained “relatively flat” at 4%. 
    • “Though the statistics indicate the hot labor market is cooling, Fitch said recruitment is still“hyper-competitive.” Health systems may need to offer higher salaries and better benefits to attract talent and dissuade skilled labor from seeking early retirement, the report said.” 
  • BioPharma Dive notes
    • “As ALS research booms, one treatment center finds itself in the spotlight.
    • “Mass General’s Healey Center is at the forefront of ALS research and care.
    • “Still, the complexities of the disease and of drug development have brought hard-felt losses.”
  • Per Fierce Healthcare,
    • “Two of southern California’s largest pediatric providers are planning to come together in 2024.
    • “The parent companies of Children’s Hospital of Orange County (CHOC) and Rady Children’s Hospital-San Diego announced Wednesday an agreement to merge under the new banner of Rady Children’s Health.
    • “The arrangement, which is subject to regulatory review, stands to help the organizations improve patient outcomes, increase access to care, accelerate treatment research and bolster their clinical and nonclinical workforces, the children’s hospitals said in their joint reveal.”

Midweek Update

David Ermer–Congress, COVID-19, Federal employment benefits, U.S. Healthcare–

From Washington, DC,

  • Govexec informs us
    • “So, 2023 is just about history. And Congress, having spent most of our last trip around the sun in political paralysis not surprisingly ran out the year’s clock in the same hardly decorous manner. 
    • “And, frankly, for feds that’s the good news. How so? Each year federal retirees and Social Security recipients get a cost-of-living adjustment that is carefully—if imperfectly—tabulated using a formula that crunches hard inflation data from the wider economy. Current federal employees, on the other hand, get their pay boost—if any—only by way of a political process. This process is governed under the Federal Employees Pay Comparability Act, or FEPCA. And when Congress does not act on this matter in a given year, then the federal pay adjustment comes from a stroke of the president’s pen. 
    • “This year, since Congress took its final recess without passing the customary appropriations bill, the White House almost certainly will issue an alternative pay plan along the lines President Biden proposed months ago: 4.7% base increase and, taking into account locality pay, an average pay boost of 5.2%.” 
  • Per Fierce Healthcare,
    • “The number of people signing up for coverage on Healthcare.gov has crossed 15 million, according to new data from the Biden administration.
    • “The Department of Health and Human Services said Wednesday that as of Dec. 15, 15.3 million people have chosen plans on the Affordable Care Act’s exchanges, surpassing previous records. On that day alone, 745,000 secured marketplace plans, the highest single day ever.
    • “Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure said in a release that sign-ups are currently up 33% year-over-year.
    • “Dec. 15 was the deadline to secure a plan that kicks in on Jan. 1.”
  • The National Academies of Science posted August 2023 workshop proceedings about “Dietary Patterns to Prevent and Manage Diet-Related Disease Across the Lifespan.”

From the public health and medical research front,

  • CBS News reports
    • “The World Health Organization announced Tuesday it would step up its classification of the new COVID-19 variant JN.1 to a standalone “variant of interest” after tracking the strain’s rapid ascent around the world. Health officials have been careful to say that JN.1 has so far not been found to lead to different or more severe symptoms compared to previous variants.
    • “However, the WHO said JN.1’s “rapidly increasing spread” in multiple parts of the world was enough to warrant ungrouping the strain from its slower-moving ancestor BA.2.86.
    • “JN.1 continues to be reported in multiple countries, and its prevalence has been rapidly increasing globally and now represents the vast majority of BA.2.86 descendent lineages reported,” the WHO wrote.”
    • The article adds that the variant will receive a Greek letter if it is promoted to a variant of concern.
  • The Wall Street Journal adds,
    • “Vaccine makers Pfizer,  Moderna and Novavax have said their updated Covid-19 shots generate immune responses against JN.1’s close parent, BA.2.86. 
    • “Data shows that all of the antibodies are a really good fit, luckily, for JN.1,” said Jeremy Kamil, a virologist at Louisiana State University Health Shreveport. “That’s really good news.”
    • “Kamil pointed out that Covid-19 vaccine uptake has been low this season, some 18% of adults having gotten a shot, according to the CDC.”
  • Health Day informs us,
    • “Standard artificial intelligence (AI) models improve diagnostic accuracy, but systematically biased AI models reduce this accuracy, according to a study published in the Dec. 19 issue of the Journal of the American Medical Association.”
  • Beckers Hospital Review notes,
    • “Amid the rise of the Ozempic, Wegovy and Mounjarno, older weight loss drugs are making a comeback in 2023, just like ripped jeans.
    • “The popular new weight loss drugs gaining attention still remain inaccessible for many due to pricing, insurance coverage or lack thereof, and shortages, which is why some adults are now turning to older weight loss drugs instead, CNN reported Dec. 20.
    • “As a result, there have been increasing prescriptions for drugs that are more within grasp. According to CNN, prescriptions for bupropion — an antidepressant medication used also to aid patients in quitting smoking with a side effect of weight loss — went up 29% between 2017 and 2023. Additionally, prescriptions for another drug, phentermine — a weight loss drug approved by the FDA in 1959 — rose 34% during the same time frame, according to the outlet.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans has named this year’s top six benefit trends.
  • Per Healthcare Dive,
    • “Philadelphia-based Jefferson Health and Allentown, Pennsylvania-based Lehigh Valley Health Network announced on Monday they signed a non-binding letter of intent to combine.
    • “If approved, the merger would join Jefferson’s hospital system with Lehigh’s 13 facilities to form a 30-hospital system with more than 62,000 employees. 
    • “Jefferson Health’s chief executive, Joseph Cacchione,will remain at the helm of the new enterprise, according to the release.”
  • and
    • “Froedtert Health and ThedaCare have finalized their merger, the systems announced Tuesday. The combined Wisconsin health system will launch on Jan. 1, 2024. * * *
    • “ThedaCare’s medical network includes eight hospitals and a medical network that serve residents in 17 counties in northeast and central Wisconsin. Froedtert provides healthcare services in southeast Wisconsin through ten hospitals and 45 health centers and clinics.”
  • and
    • “UnitedHealth and its pharmacy benefit manager OptumRx are being sued by an independent pharmacy for allegedly strong-arming pharmacies into agreeing to “unconscionable” performance-based fees, threatening their financial health.
    • “Those fees, called DIR or direct remuneration fees, allow PBMs to retroactively adjust how much pharmacies are reimbursed based on their quality performance. Osterhaus Pharmacy in Iowa is suing OptumRx for allegedly coercing the pharmacies to accept one-sided contracts including the fees — which at times force pharmacies to dispense prescriptions at a loss — or lose access to the millions of beneficiaries with pharmacy benefits through the PBM.
    • “The suit seeks class action status to include thousands of independent pharmacies with similar contracts with OptumRx. Osterhaus brought a similar suit against CVS in September.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, OPM, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “The House [of Representatives] voted Thursday to clear the fiscal 2024 National Defense Authorization Act and send it to President Joe Biden for his signature.
    • “The conference report was considered under suspension of the rules, which requires a two-thirds majority. The bipartisan package easily cleared that threshold on a 310-118 vote. * * *
    • “The conference report is notable for authorizing a 5.2 percent pay raise for all military personnel, the biggest in two decades, as well as an increase in troops’ basic allowance for housing payments.”
  • Govexec adds that “Under a provision of the fiscal 2024 National Defense Authorization Act, federal agencies would be required to incorporate veterans’ military service when determining eligibility for paid leave.”
  • Back to Roll Call,
    • “The Senate planned to delay its holiday recess and stay in session next week as lawmakers signaled they could be close to a bipartisan border security deal that would clear a path for aid to Ukraine and Israel.
    • “The change in schedule came after several days of intense negotiations among senators of both parties and White House staff who were struggling to reach a deal on immigration policies designed to curb the flow of migrants at the southern border. Republicans have insisted on tougher border security as their price for additional Ukraine aid, part of a broader $110.5 billion supplemental funding package.
    • “We can get this done before we leave,” said Connecticut Sen. Christopher S. Murphy, the lead negotiator for Senate Democrats, after a Thursday morning negotiating session. “I just think if . . . the border is an emergency, if Ukraine is an emergency, then let’s act like it.” ***
    • “Even if the Senate can agree to a package combining border security with military aid to Ukraine and Israel, the measure is unlikely to become law this month. The House recessed for the year Thursday and Speaker Mike Johnson, R-La., appeared unlikely to call the chamber back into session before January.”
  • MedPage Today reviews several drug pricing developments that the Biden Administration announced this morning.
  • What’s more,
    • “HHS released a new data strategy to enhance data capabilities and accelerate progress on cancer moonshot goals,”
  • and
    • “The Biden-Harris Administration announced voluntary commitments from leading healthcare companies to harness the potential and manage the risks posed by AI.”
  • Govexec tells us,
    • “The Office of Personnel Management on Wednesday urged supervisors at federal agencies to take a more active role in managing the performance of new federal employees, including removing those who perform poorly and improving engagement to ensure they have the tools to succeed.”

From the public health and medical research front,

  • The Centers for Disease Control issued a health alert.
    • “to alert healthcare providers to low vaccination rates against influenza, COVID-19, and RSV (respiratory syncytial virus). Low vaccination rates, coupled with ongoing increases in national and international respiratory disease activity caused by multiple pathogens, including influenza viruses, SARS-CoV-2 (the virus that causes COVID-19), and RSV, could lead to more severe disease and increased healthcare capacity strain in the coming weeks. In addition, a recent increase in cases of multisystem inflammatory syndrome in children (MIS-C) following SARS-CoV-2 infection in the United States has been reported
    • “Healthcare providers should administer influenza, COVID-19, and RSV immunizations now to patients, if recommended. Healthcare providers should recommend antiviral medications for influenza and COVID-19 for all eligible patients, especially patients at high-risk of progression to severe disease such as older adults and people with certain underlying medical conditions.
    • “Healthcare providers should also counsel patients about testing and other preventive measures, including covering coughs/sneezes, staying at home when sick, improving ventilation at home or work, and washing hands to protect themselves and others against respiratory diseases.”
  • Mercer Consulting notes,
    • “With the release in August of the first orally administered medication for postpartum depression, now is a good time to review plan coverage and overall employer support for maternal health. While there are risk factors, postpartum mental health issues can happen to anyone within a year of birth and are often made worse by a lack of social support, including from the workplace. Sadly, the Centers for Disease Control and Prevention reported that mental-health conditions have become the leading cause of maternal death, contributing to nearly one in four pregnancy-related deaths.” 
  • The Robert Wood Johnson Foundation shares its five best health equity stories of 2023.
  • EHR Intelligence adds, “The Regenstrief Foundation has awarded LOINC and Health Data Standards at Regenstrief Institute a $4.4 million grant to support a global initiative to standardize social determinants of health (SDOH) data into EHR systems.”
  • The CDC reports about “Teenagers in the United States: Sexual Activity, Contraceptive Use, and Childbearing, 2015–2019.”
    • “In 2015–2019, 40.5% of never-married female teenagers (3.8 million), and 38.7% of never-married male teenagers (3.8 million) had ever had vaginal intercourse with an opposite-sex partner. For females this percentage was stable across the four time points, but for males this percentage decreased from the 2002 (45.7%) and 2011–2015 (44.2%) time points.
    • “For teen males, use of any contraception at first sex increased across the four time points, from 82.0% in 2002 to 92.1% in 2015–2019, while no consistent trend was seen for teen females.
    • “Nearly four out of five female teenagers (77.3%) in 2015–2019 used a method of contraception at first sex. Among female teenagers, ever-use of long-acting reversible contraception, which includes intrauterine devices and contraceptive implants, increased from 5.8% to 19.2% from 2011–2015 to 2015–2019.”
  • Beckers Hospital Review lets us know,
    • “Results from a phase 2 trial found a drug-vaccine combination developed by Merck and Moderna cut the risk of recurrence or death in patients with severe melanomas by 49%.
    • “The experimental therapy involves an mRNA vaccine from Moderna in combination with Merck’s cancer drug Keytruda. Patients with resected stage 3 or 4 melanoma who received the combination therapy were 49% less likely to die or have their cancer return within three years, compared to those who received only Keytruda.
    • “The findings build on results from an earlier phase study that followed patients for two years, the drugmakers said in a Dec. 14 news release.” 
  • Bloomberg Prognosis informs us,
    • “Obesity researchers are only beginning to explore what happens after people lose weight with GLP-1 drugs such as Wegovy or Zepbound. Most trials of the drugs have only lasted a year or so. While some type of long-term drug therapy is likely to be needed — just as it is with other diseases like high blood pressure — exactly what form it will take is a big unknown, says Robert Kushner, an obesity doctor at Northwestern University Feinberg School of Medicine.
    • “This whole idea of maintenance is a huge black hole,” Kushner told my colleague Madison Muller in a recent interview. “We’re going into this area but we don’t have the long-term game figured out.”
  • Per Medscape,
    • “For researchers involved with sleep disorders, developing a pharmacologic treatment for obstructive sleep apnea (OSA) is a bit like searching for the holy grail. P K Schweitzer and colleagues have published the results of the randomized MARIPOSA study assessing a combination of two medicinal products known as AD109, one of the products having an antimuscarinic effect (aroxybutynin), and the other a noradrenergic effect (atomoxetine), in treating this condition. These molecules increase the activity of the dilator muscles in the upper airways by activating the genioglossus muscle with a synergic effect on the upper respiratory tract during sleep. * * *
    • [T]hese results herald important scientific benefits if we consider that Colin Sullivan’s original 1981 research paper, which ushered in the CPAP era, presented the results of just five participants. 
  • The Wall Street Journal reports,
    • “A year and a half of treatment with the new Alzheimer’s drugs has been shown to reduce the chance of progression to mild stage dementia by about 10%. This benefit comes with notable risks, including small patches of brain bleeding and swelling, which can cause falls and confusion and may require stopping the drug. And there are other barriers. The new Alzheimer’s therapies are very expensive—one year of lecanemab therapy is priced at $26,500. They are difficult to deliver, require an extensive work-up to determine eligibility and involve intensive monitoring for side effects. As many as 8 million Americans are estimated to be living with mild cognitive impairment, but only about 8% to 17.4% will meet all the criteria to take one of these drugs, according to a study published last month in the journal Neurology.”

From the U.S. healthcare business front,

  • Merck Consulting looks back at top benefit trends from 2023 that it expects to carry over into 2024.
  • Beckers Hospital Review explains
    • “Healthcare leaders have been talking about the transition to value-based care for years, but without significant movement away from fee for service. That could all change in the next three years.
    • “The current economic climate, with tightening margins and increased costs, is pushing health systems to finally make a move.
    • “We will continue to see margin pressure resulting from reimbursement rates not keeping pace with inflationary trends that are escalating staffing and supply chain costs,” said Cliff Megerian, MD, CEO of University Hospitals in Cleveland. “As a result, you will see health systems optimizing their operations, which may include footprint re-evaluation, increasing focus on value-based care and greater utilization of digital technology, such as remote monitoring and telehealth services.”
    • “Dr. Megerian also sees more partnerships and expanded services as the growth mechanism for health systems instead of the traditional brick-and-mortar projects and acquisitions.”
  • Per Fierce Healthcare,
    • “Most insurer markets are highly concentrated, including many regions where a single payer dominates at least half of the market share, according to a new analysis from the American Medical Association.
    • “The AMA [hardly a neutral observer] released an updated look at concentration in payer markets and found that across product lines, 73% of metropolitan statistical areas were highly concentrated in 2022. In most (90%) regions, a single payer owns a 30% market share, and in 48% of markets, one payer controls at least 50% of the share.
    • “In 11% of markets, a single insurer has a 70% or higher market share, according to the report.”
  • Per Healthcare Dive,
    • “Private equity firm KKR is in talks to buy a 50% stake in healthcare data analytics firm Cotiviti from Veritas Capital, according to The Wall Street Journal. 
    • “The deal, which sources familiar said could be finalized in the coming weeks, would value the health technology company at about $11 billion. Veritas acquired Cotiviti in a take-private deal valued at $4.9 billion in 2018. 
    • “If the purchase is finalized, it would also rate among the largest U.S. private equity deals announced this year, according to the WSJ.” 

Weekend update

David Ermer–CDC, Congress, Federal employment benefits, OPM, U.S. Healthcare–

From Washington, DC,

  • The American Medical Association reports,
    • “As of today, patients and physicians have a clear-eyed view on how to protect Medicare from injurious cuts. A bipartisan group of House members— led by Reps. Greg Murphy, M.D., (R-N.C), Danny Davis, (D-Ill.), Brad Wenstrup, D.P.M. (R-Ohio), Jimmy Panetta (D-Calif.), Larry Bucshon, M.D. (R-Ind.) and Michael Burgess, M.D. (R-Texas)—introduced HR 6683 that would eliminate the pending 3.37 percent cuts to Medicare payments. These cuts threaten healthcare access for seniors as well as the viability of physician practices, including many in rural and underserved areas. Canceling the cut is a good new year’s resolution.”
  • The Federal Benefits Open Season ends tomorrow, December 11.
    • OPM explains that “The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday, December 11, 2023, for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) ends at 11:59 pm, in the location of your electronic enrollment system, on Monday, December 11, 2023.”

From the public health front,

  • Fortune Well provides background on pneumonia, the lung disease that is the number one cause of hospital admission in children and adults.
  • Bloomberg Prognosis delves into the old saying, “Feed a cold and starve a fever,” which dates back to the 16th century. Well, it turns out that your best bet is to feed colds and fevers according to Bloomberg.
  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention on Friday warned clinicians and the public about an outbreak of a rare but deadly tick-borne disease that hospitalized five patients in Southern California, killing three of them, after they traveled to or lived in a Mexican border city in recent months.
    • “Rocky Mountain spotted fever (RMSF) is transmitted by the bite of infected ticks that live primarily on dogs. It’s rare in the United States but it has emerged at epidemic levels in northern Mexico, where more than 2,000 cases, resulting in hundreds of deaths, have been reported in the past five years.
    • “In a health advisory issued late Friday, the CDC said the five patients had been diagnosed since late July. All had traveled to or lived in the city of Tecate, in the northern Mexican state of Baja California, within two weeks of getting sick. All five sought care in hospitals in Southern California, including four pediatric patients. CDC officials declined to provide more details about the individuals to protect their privacy. Three of the patients were U.S. residents, and two were siblings who lived in Mexico. Two deaths were pediatric patients and one was an adult, CDC officials said.”
  • The Post also discusses nitazenes, a street opioid more potent than fentanyl.
    • “Naloxone, the commonly used overdose reversal drug, can revive nitazene users. But nitazenes may complicate rescue efforts if users or medical personnel do not know the drugs have been consumed. In a study published in August, researchers found that a small group of emergency room patients who had taken nitazenes needed more naloxone than people overdosing on fentanyl. Two patients who ingested a compound known as metonitazene suffered heart attacks. One died, according to the study in JAMA Network Open.
    • “The concerns about nitazenes being more potent than fentanyl were confirmed by the study,” said Alex F. Manini, a study co-author and a professor of emergency medicine at the Icahn School of Medicine at Mount Sinai in New York.”

We have big news from the U.S. healthcare business front.

  • The Wall Street Journal reported this afternoon,
    • “Cigna abandoned its pursuit of a tie-up with  Humana that would have created a roughly $140 billion giant in the health-insurance industry.
    • “The companies couldn’t come to an agreement on price and other financial terms, according to people familiar with the matter. In the near term, Cigna is turning its focus toward smaller, so-called bolt-on acquisitions. * * *
    • “Instead, Bloomfield, Conn.-based Cigna plans an additional $10 billion of stock buybacks, bringing its total planned repurchases to $11.3 billion. * * *
    • “Humana, the No. 2 Medicare insurer, remains in the midst of its own succession handoff. Humana said in October that Jim Rechtin—previously chief executive of Envision Healthcare—would take over as president and chief operating officer, effective Jan. 8. Rechtin is then to take over as chief executive officer from Bruce Broussard in the back half of 2024.” 

Friday Factoids

David Ermer–ACA, AHRQ, Congress, Federal employment benefits, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Endpoints informs us,
    • “In a landmark moment for genetic medicine and sickle cell disease patients, the FDA on Friday approved not just one but two gene therapies for the disease: Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy, marking the first-ever approval of a CRISPR-based medicine in the US, and Lyfgenia, bluebird bio’s lentiviral gene therapy.
    • “The treatments are approved for sickle cell disease patients 12 years of age and older who experience painful attacks associated with the disease. Vertex will charge $2.2 million in the US for Casgevy, while bluebird will charge $3.1 million for Lyfgenia.
    • “This is the very first time that some patients have ever imagined that they might not have to live their entire lifespan with the consequences of sickle cell disease,” Alexis Thompson, the chief of the division of hematology at Children’s Hospital of Philadelphia and investigator on the clinical trials that led to the therapies’ approvals, told Endpoints News ahead of the announcement.” * * *
    • “ICER, a drug pricing watchdog, has suggested the therapies could be cost-effective at $2 million in the US. Bluebird bio markets a gene therapy as Zynteglo for transfusion-dependent beta thalassemia as well in the US, for which it charges $2.8 million.”
  • Per Fierce Healthcare,
    • “New polling suggests voters would rather work to improve the current U.S. healthcare system and keep the Affordable Care Act in place, rather than drastically overhaul the system in favor of a national public option or Medicare for All.
    • “Three-quarters of survey respondents said they prefer fixing the current health insurance system versus starting fresh with a Medicare for All system, while 64% said Medicare should begin at the age of 60 instead of 65 and 58% believe people should be allowed to purchase health insurance beginning at the age of 50.
    • “Repealing the ACA struck a chord with respondents as just 32% of voters and only 44% of GOP voters said they support repealing the ACA. When asked if ACA subsidies should be extended, 60% said they should while only 41% of Republicans agreed.
    • “Notably, the survey was conducted on behalf of the Partnership for America’s Health Care Future, an industry group created in 2018 comprised of America’s Health Insurance Plan, the American Hospital Association, BlueCross BlueShield Association, the Federation of American Hospitals, PhRMA and other major hospital systems, payers and healthcare advocacy groups that seek to quell support and prevent passage of Medicare for All.” 
  • Healthcare Dive tells us,
    • “Hospitals are up in arms over a bill in the U.S. House of Representatives that would equalize payments for drugs administered in outpatient clinics, regardless of ownership.
    • “The American Hospital Association and the Federation of American Hospitals sent separate letters to Congress this week urging legislators to vote against the bill over the site-neutral provision, arguing it would threaten access to care by cutting hospitals’ Medicare payments.
    • “The bipartisan Lower Costs, More Transparency Act is scheduled to come up for a House vote the week of Dec. 11.”
  • Fierce Healthcare offers more information on this bill (HR 5378).
    • [T]he legislation would ban spread pricing in Medicaid, force PBMs and providers to adopt President Trump-era transparency rules, push closer toward site-neutral payment reform, extend a federal program due to expire and approve funding increases for community health centers.
  • The American Hospital Association News points out,
    • The Medicare Payment Advisory Commission Dec. 8 discussed draft payment update recommendations for 2025, which the commission will vote on in January. The draft recommendations call for Congress to update Medicare payment rates for hospital inpatient and outpatient services by the current law amount plus 1.5%, and transition to a safety-net index policy that would distribute an additional $4 billion to safety-net hospitals. They also propose that Congress:
      • Update 2025 Medicare payments for physicians and other health professional services by 50% of the Medicare Economic Index increase, and enact a non-budget-neutral add-on payment under the physician fee schedule to services provided to low-income Medicare beneficiaries.
      • Reduce the 2025 payment rate for home health agencies by 7%.
      • Reduce the 2025 payment rate for skilled nursing facilities by 3%.
      • Reduce the 2025 payment rate for inpatient rehabilitation facilities by 5%.
  • On December 6, the Biden Administration’s latest semi-annual regulatory agenda was posted. Here is a link to OPM’s agenda. Here are the FEHB rulemakings in process:
    • OPM Proposed Rule Stage Federal Employee Health Benefits Program: Effective Date of Coverage RIN 3206-AO47
    • OPM Proposed Rule Stage Postal Service Health Benefits Program: Additional Requirements and Clarifications RIN 3206-AO59
    • OPM Proposed Rule Stage Federal Employee Health Benefits Program: Decreasing Enrollment Type to Self Only RIN 3206-AO62
    • OPM Final Rule Stage Requirements Related to Air Ambulance, and Agent, and Broker Services, and Provider Enforcement RIN 3206-AO28
    • OPM Final Rule Stage Postal Service Health Benefits Program RIN 3206-AO43
  • Readers can research these rulemakings on regulations.gov by referencing the RIN.

From the public health and medical research front,

  • The Department of Health and Human Services announced
    • “In first-of-its-kind research to examine racial and ethnic disparities in the medical costs of smoking in the United States, the Department of Health and Human Services’ Agency for Healthcare Research and Quality (AHRQ) found that adults from some racial and ethnic populations benefit substantially more than others from tobacco control policies. The research, published today in the journal Tobacco Control, supports President Joe Biden’s April 2023 Executive Order calling for policymakers to examine distributional effects in cost-benefit analyses required in the rulemaking process.  This study helps inform such analyses and will benefit other research in this area.
    • “The study shows that even though adults in specific racial and ethnic populations have a lower ever-smoked rate than White adults and make more attempts to quit, their medical spending associated with smoking was twice as high, with a 41% higher rate of having multiple chronic conditions associated with smoking. * * *
    • “Disparities in medical spending, as well as adverse health outcomes, are continuing to increase over time,” said AHRQ co-author Dr. William Encinosa. “AHRQ’s results indicate that racial and ethnic populations benefit substantially from tobacco control policies, such as tobacco product regulations.”
    • “The article, “Racial and Ethnic Disparities in the Healthcare Costs and Outcomes of Smoking in the United States: 2008-2019,” is published in Tobacco Control and may be found at: https://tobaccocontrol.bmj.com/lookup/doi/10.1136/tc-2023-058136“
  • Medscape notes,
    • “Patients receiving semaglutide for weight loss show a significantly higher rate of continuing the medication at 1 year compared with less effective anti-obesity drugs. However, even among those patients, continuation declines to fewer than half of patients.
    • “We now have effective US Food and Drug Administration-approved anti-obesity medications; [however], this study shows that in a real-world setting, the vast majority of patients discontinued their prescription fills within the first year,” said first author Hamlet Gasoyan, PhD, lead author of the study and a researcher with Cleveland Clinic’s Center for Value-Based Care Research, said in a press statement.
    • “The study was published online today in the journal Obesity.”
  • HR Morning fills us in on cancer benefit trends in 2024 and how employers can support employees fighting cancer.
  • Per MedPage Today,
    • “An outbreak of Clade I mpox virus is currently spreading in the Democratic Republic of the Congo (DRC), and clinicians should be aware of the potential for transmission from people traveling from the Central African country, the CDC said Thursday in a Health Alert Network advisoryopens in a new tab or window.
    • “Of the two distinct mpox subtypes, Clade I is endemic in Central Africa, and appears to be more transmissible and causes more severe infections than the Clade II subtype. So far, no Clade I mpox infections have been detected in the U.S. during surveillance testing. The current threat for Clade I mpox in travelers remains low, the CDC said, in part because there are no direct commercial flights to the U.S. from the DRC.”

From the U.S. healthcare business front,

  • Becker’s Payer Issues explains how BCBS plans are using price transparency data.
    • “It’s been nearly two years since payers have been required to publish the costs of their in-network provider rates for covered items and services, and now Blue Cross Blue Shield plans are using that data to create actionable insights for stakeholders across the healthcare system.
    • “Much of that work is being done by Blue Health Intelligence, the data and analytics arm of the BCBS Association that is collectively owned by 17 BCBS affiliates. Becker’s sat down with BHI CEO Bob Darin to learn how Blues plans around the country are utilizing price transparency data, and the major challenges that still lie ahead.”
  • Check out the interview.
  • HR Dive reports,
    • “The U.S. government published its fall regulatory agenda Wednesday, sharing its rulemaking plans for the remainder of 2023 and early 2024.
    • “Of interest to HR professionals are U.S. Department of Labor updates on wage and hour law, workplace safety and retirement plans. Perhaps most notably, the DOL plans to finalize overtime regulations in April 2024. Final regulations for independent contractor classification — under the Fair Labor Standards Act — hang in the balance, as they were slated to be published in November, per the DOL.
    • “Separately, the U.S. Equal Employment Opportunity Commission said it will finalize Pregnant Workers Fairness Act rules in December.”
  • The Society for Human Resource Management advises
    • “With the end of the year quickly approaching, HR and benefits leaders have yet one more task to add on to their busy end-of-year checklist: reminding employees about approaching deadlines to use up remaining cash in their health care flexible spending accounts (FSAs). ***
    • “So how should employers share end-of-year news about FSAs? And what should they say?
    • “One of the best ways to remind employees is to send multiple emails during the remainder of the year, Dinich said, adding that if company leaders simply raise the issue in a company meeting, anyone who is on leave or out sick won’t get that reminder.
    • “Make sure to reiterate any terms and conditions within that email and advise on checking which expenses are eligible, so that employees can refer back to this when making claims before the end of the year,” he said. “Also ensure that it’s clear when the expiry date is, as some plans are tied to specific dates rather than defaulting to the end of the year.”

Happy Hanukkah

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Hanukkah greeting template. Hand-drawn sketch illustration. Unsplash.

From Washington, DC,

  • The White House posted a fact sheet on the steps that the Administration is taking to lower health and prescription drug costs.
  • Following up on yesterday’s post, BioPharma Dive adds
    • The White House on Thursday took steps to pressure pharmaceutical companies to lower the price of drugs developed with federal funding, backing a plan that would enable the government to sidestep patent protections for those medicines.
    • New draft guidelines published by the National Institutes of Standards and Technology permit government agencies to consider “reasonableness of the price” when evaluating whether to invoke so-called march-in rights, which permit the government to suspend patents when federally funded inventions aren’t made available to the public.
    • The newly published framework gives agencies the power to act “if it appears that the price is extreme, unjustified, and exploitative of a health or safety need.” One example is a “sudden, steep price increase in response to a disaster,” although the initial cost of a drug when it’s launch can also be considered, the guidance said.
    • The agency is seeking further comment on its guidance — the product of an interagency review that began early this year — before publishing a final version.
  • The Senate Finance Committee leadership announced that “the Committee has reported legislation that was marked up in the committee in November. The “Better Mental Health Care, Lower-Cost Drugs, and Extenders Act” addresses a number of important health care priorities in the committee’s jurisdiction.”
    • “The final reported legislative text can be found here. A section by section summary can be found here.”
  • American Hospital News tells us,
    • “The House Energy and Commerce Committee Dec. 6 advanced 19 health care bills, including legislation (H.R. 6364) that would prevent Medicare from publicizing a telehealth provider’s home address when the provider delivers telehealth services from their home. AHA has additionally urged Congress to remove a requirement that these telehealth providers report their home address on Medicare enrollment and claims forms effective Jan. 1, 2025. 
    • “The committee also advanced H.R. 6545, as amended, which included provisions that were part of two other bills that had previously moved through the health subcommittee: H.R. 6366, to extend for one year the Geographic Practice Cost Index floor for physician work under the Medicare Physician Fee Schedule; and H.R. 6369, to extend the 3.5% incentive payment for eligible Advanced Alternative Payment Model participants for the calendar year 2026 period. AHA supports the extension, but would prefer Congress to restore the incentive payment to 5% and remove the legislation’s payment reductions for longstanding participants.”
  • MedPage Today offers insights into a December 5 Senate Finance Committee hearing on drug shortages.
  • The Government Accountability Office issued a report on “improper payments and fraud: how they are related but different.” OPM has focused FEHB carrier attention on this topic in 2023.

In federal benefit news,

  • FedWeek discusses how FEHB premiums compare for retirees versus employees.
  • Govexec reports,
    • “For the third time this year, the federal government’s backlog of pending retirement claims filed by departing federal workers hit a six-year low, as the Office of Personnel Management continues its focus on improving a process that has long pestered agencies and retirees alike.
    • “OPM reported Tuesday that its retirement backlog fell to 15,826 pending cases at the end of November. That’s the second time the inventory fell below 16,000 this year, and the third time this year that the backlog reached a six-year record low, dating back to when it briefly felt to around 14,000 in 2017. OPM’s goal is a “steady state” of 13,000 pending claims at any given time.
    • “In 2023, the retirement backlog has fallen in seven out of 11 months. Last month, the average processing time fell across multiple metrics. Measured on a monthly basis, the average processing time of a retirement claim fell from 73 days in October to 66 last month. And the average processing time so far this fiscal year—or since Oct. 1—fell from 73 at the end of last month to 69 days.”

From the public health and medical research front,

  • The Washington Post offers helpful advice on wounds that aren’t healing properly.
  • JAMA Network posts observations on GLP-1 drugs from last October’s Obesity Week meetings. Of note,
    • “Jacinda Nicklas, MD, MPH, gave a talk at the conference showing that females often respond better to newer antiobesity medications than males.
    • “Something that we’re gradually becoming more aware of over time is that GLP-1s, in general, seem to work better in females,” Nicklas, an associate professor of internal medicine at CU School of Medicine who specializes in obesity and women’s health, said in an interview with JAMA.
    • “Nicklas did not present new research, but instead combed through past studies of GLP-1 agonists. She said sex differences haven’t often been separated out in studies and that the majority of participants in the clinical trials are females.
    • “Digging into the data from the STEP trials of semaglutide, she said females had greater weight reduction than males. The same was true in a phase 2 clinical trial of retatrutide for treatment of obesity without type 2 diabetes. Participants who received the highest dose lost an average of 24% of their body weight but females lost much more: about 29% compared with about 20% for males.”
  • MedPage Today tells us that an “Alzheimer’s Blood Test Predicts Who Might Benefit Most From Anti-Amyloid Drugs — Novel two-cutoff approach may reduce need for confirmatory PET scans.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out that “U.S. News and World Report released a list December 5 recognizing hundreds of hospitals for maternity care.” Becker’s article includes that list.
  • Beckers Health IT notes,
    • “CVS is planning to release a new mobile healthcare app designed to function as a central hub for its healthcare services.
    • “The app, teased in a video at the company’s Dec. 5 investor meeting, can help consumers manage their prescriptions while providing access to informative health tips. 
    • “Some of the app’s other features include an augmented reality store navigation and a function that allows consumers to schedule appointments at CVS MinuteClinics and CVS-owned Oak Street Health. 
    • “An AI-powered chatbot will also be integrated into the app so consumers can get their questions answered.  
    • “CVS did not detail when the app would be released.”
  • The Wall Street Journal reports,
    • “Merck & Co. is ending a late-stage study of the combination of Keytruda and Lynparza in certain lung cancer patients due to an expected failure of the trial.
    • “The Rahway, N.J., drugmaker, which was evaluating Keytruda in combination with maintenance Lynparza in a Phase 3 study in patients with metastatic squamous non-small cell lung cancer, said it is stopping the trial for futility based on the recommendation of an independent data monitoring committee.”

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SDOH, U.S. Healthcare–
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

David Ermer–CDC, Congress, COVID-19, Electronic health records, Employee Wellness Programs, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
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.”