Tuesday Tidbits

U.S. Healthcare

Tuesday Tidbits

David Ermer–Congress, FDA, NIH, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Roll Call provides this wrap up.
    • “With no prospect for a border security deal in sight, the Senate was preparing to leave town for the holidays and punt an emergency war funding package into the new year.
    • “Majority Leader Charles E. Schumer, D-N.Y., acknowledged Tuesday that reaching a bipartisan deal on policies to stem the flow of migrants at the southern border would not come together in time for a vote this week. 
    • “While we’ve made important progress over the past week on border security, everyone understands that we have more work to do and it’s going to take more time,” Schumer said on the floor.”
  • The Census Bureau reports, “Births in 2023 once again began to outpace deaths in over half of U.S. states as mortality declined, inching closer to pre-pandemic levels, according to U.S. Census Bureau population estimates released today.”
  • The Food and Drug Administration tells us,
    • “Today, the FDA approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder. As part of a clinical evaluation, the AutoGenomics Inc. AvertD test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure. The AvertD test, a prescription-use only genetic laboratory test for patients 18 years and older, is to be used only with patients who consent to the test and have no prior use of oral opioid analgesics.
    • “Today, the FDA refreshed the Know Your Treatment Options for COVID-19 Consumer Update and reminded consumers that they have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use. In addition, more therapies are being tested in clinical trials to evaluate whether they are safe and effective in treating COVID-19.” 
  • HHS’s Agency for Healthcare Research and Quality has issued its 2023 National Healthcare Quality and Disparities report.
  • The International Foundation of Employee Benefits Plans tells us,
    • “The Internal Revenue Service (IRS) released Notice 2024-01 providing the percentage increase for calculating the qualifying payment amounts (QPAs) for items and services furnished in 2024 under sections 9816 and 9817 of the Internal Revenue Code. These provisions, added by the No Surprises Act, provide protections against surprise medical bills in certain circumstances. The QPA calculation is required in the case of a plan or issuer that does not have sufficient information to calculate the median of the contracted rates for the same or similar item or service provided in a geographic region. 
    • “For such an item or service furnished in a subsequent year (before the first sufficient information year for the item or service with respect to such plan or coverage or before the first year for which an eligible database has sufficient information to calculate a rate under 29 CFR 2590.716-6(c)(3)(i), and 45 CFR 149.140(c)(3)(i) in the immediately preceding year), the plan or issuer must calculate the QPA by increasing the QPA amount determined for the item or service for the year immediately preceding the subsequent year, by the percentage increase in the U.S. city average consumer price index (CPI-U) over the preceding year.
    • “The percentage increase in the CPI-U for items and services provided in 2024 over the preceding year is the average CPI-U for 2023 over the average CPI-U for 2022. Pursuant to this calculation, the percentage increase from 2023 to 2024 is 1.0543149339. Plans and issuers may round any resulting QPAs to the nearest dollar.”
  • The American Hospital Association News informs us,
    • “The Department of Labor Dec. 19 [proposed to] rescind a 2018 final rule which modified the definition of “employer” under federal law such that more individuals, including sole proprietors, were eligible to participate in association health plans based on geography or industry. That provision was previously vacated by a federal judge in 2019 and was appealed by the Trump Administration. In 2021, a stay was requested by the Biden Administration while it worked on a proposed rule to rescind the 2018 final rule.” 
  • The New York Times offers an overview of the approaches the Congress is considering to ease prescription drug shortages.

From the public health and medical research front,

  • JAMA provides the following key points from a recent study,
    • “Question  What is the impact of dietary sodium intake on blood pressure in middle-aged to elderly individuals?
    • “Findings  In this prospectively allocated diet order crossover study of 213 individuals, 1 week of a low-sodium diet resulted in an average 8–mm Hg reduction in systolic blood pressure vs a high-sodium diet, with few adverse events. The low-sodium diet lowered systolic blood pressure in nearly 75% of individuals compared with the high-sodium diet.
    • “Meaning  In this trial, the blood pressure–lowering effect of dietary sodium reduction was comparable with a commonly used first-line antihypertensive medication.”
  • Newly installed NIH Director Monica Bertagnolli offers her first Director’s blog on the topic of “Turning Discoveries to Health for All.”
  • Axios reports, “The new highly effective class of anti-obesity drugs has often been talked about as an alternative to bariatric surgery — but medications like Wegovy are increasingly being paired with the procedure.”
    • “Between 20% and 35% of patients who receive the most commonly performed bariatric surgery gain back most of the weight or fail to hit a certain target for body mass index.
    • “Combining one of the GLP-1s with bariatric surgery or endoscopic bariatric therapy, which is a less invasive procedure, “provided significant weight loss” when compared with those procedures alone, according to a systemic review of 11 studies that was published in the Journal of the Endocrine Society this month.
    • “The drugs will revolutionize for sure the landscape of bariatric treatment,” Enrique Elli, a bariatric surgeon at the Mayo Clinic, told Axios. “As a surgeon, I welcome these drugs because I think that will make bariatric surgery even more effective.”
  • The Wall Street Journal points out, “Hemp Gummies Are Sending Hundreds of Kids to Hospitals. Surge of THC products, vapes has states struggling to regulate the booming market.”
    • “The market has boomed in recent years, especially since 2021. Estimates of its size vary, but research firm Whitney Economics approximates the hemp-derived cannabinoids market at $28 billion—about the same size as craft beer and legal marijuana. About 10% of that figure represents products containing cannabidiol, or CBD, which isn’t intoxicating. ***
    • “The FDA has warned that the intoxicating products are dangerous to children but has said it needs Congress to pass a new law that would allow it to regulate cannabis products generally.
    • “This is a serious public health issue, and a solution is urgently needed,” said Patrick Cournoyer, who helps lead the committee studying cannabis for the FDA.
    • “Federal lawmakers have asked cannabis experts and companies to weigh in on possible legislation. Many of those invested in the debate hope Congress will address the issue in the Farm Bill next year.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Federal antitrust agencies on Monday finalized stricter guidelines for mergers and acquisitions that could make it more difficult for healthcare deals to close.
    • “The guidelines lay out a framework that the Department of Justice and Federal Trade Commission use when reviewing proposed deals and that the courts can reference in overseeing challenges. However, the guidelines are not legally binding themselves.
    • “The final merger guidelines are not meaningfully different from draft guidelines the DOJ and FTC released in July, according to antitrust experts.”
  • KFF has posted a report captioned “Recent Trends in Medicaid Outpatient Prescription Drug Utilization and Spending.”
    • Key findings include:
      • Even though Medicaid enrollment reached historic levels during the continuous enrollment period, Medicaid prescription drug utilization remained below FY 2017 levels through FY 2022.
      • Net spending (spending after rebates) on Medicaid prescription drugs is estimated to have grown in recent years, increasing from $29.8 billion in FY 2017 to $43.8 billion in FY 2022, a 47% increase.
      • Despite lower utilization, Medicaid spending on prescription drugs has increased, and both states and the federal government continue to take action to combat rising costs.
    • These findings are noteworthy because, typically, Medicaid receives the lowest available prices for prescription drugs.

Monday Roundup

David Ermer–Congress, Generative AI, Medical / Rx research, No Surprises Act, SDOH, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The New York Times reports,
    • “The prospects for passing legislation to speed military aid to Ukraine this year are fading, as Republicans balk at striking a quick deal on immigration policy changes they have demanded in exchange for allowing the bill to move forward.
    • “After a weekend of intensive bipartisan border talks yielded progress but no breakthrough, Senator Chuck Schumer, Democrat of New York and the majority leader, acknowledged on Monday that negotiators were still far from completing a deal.
    • “It’s going to take some more time to get it done,” he said on the Senate floor on Monday afternoon, laying out plans for the week that made no mention of any votes on the aid package for Ukraine.”
  • Govexec tells us that “The Senate on Monday voted 50-11 to confirm former Maryland Gov. Martin O’Malley as commissioner of the Social Security Administration, ending a drought of more than two years in which the embattled agency lacked a permanent leader at the helm.”
  • Fierce Healthcare informs us,
    • “The Biden administration on Monday released amended fees related to independent dispute resolution under the No Surprises Act.
    • “In the amended final rule, CMS said it will instead set an administrative fee of $115 for disputes that are subject to the rule. A separate rule, which is up for comment until Jan. 2, adjusts the fees for disputes initiated after Jan. 1, 2025. * * *
    • “In addition, CMS outlined ranges for certified IDR entity fees, which the arbiters charge for determinations. Under the rule, the agency finalized a range of between $200 and $840 for a single determination and between $268 and $1,173 for batch rulings.
    • “These fees are also set annually, and IDRs can request to update them once each year, which the feds must approve.”
    • The rule takes effect on January 20, 2023.

From the public health and medical research front,

  • STAT News points out,
    • “As more data emerges that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms.
    • “A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss.
    • “In mice experiments, scientists found that the treatments, known as GLP-1-based drugs, acted through the brain to reduce inflammation throughout the body. This was over a short period of time before the mice lost weight, according to the study, published Monday in Cell Metabolism.
    • “Though the researchers only studied mice, and didn’t look at how much the reduced inflammation translates to actual health benefits, they detailed a previously unknown mechanism of GLP-1 drugs that may help explain their effects on organs throughout the body.
    • “This is a new model for the anti-inflammatory actions of GLP-1” drugs, said Daniel Drucker, senior author of the study and a senior scientist at the Lunenfeld-Tanenbaum Research Institute.”
  • JAMA Pediatrics provides good news:
    • “Question  Is maternal influenza vaccination during pregnancy associated with a reduction in influenza-associated hospitalizations and emergency department (ED) visits in infants younger than 6 months?
    • “Findings  In this case-control study of 3764 infants younger than 6 months, maternal vaccination was associated with a reduction in influenza-associated hospitalizations and ED visits in infants. Vaccine effectiveness was highest among hospitalized infants, those younger than 3 months, and those born to mothers vaccinated in the third trimester.
    • “Meaning  The findings in this study indicate that maternal influenza vaccination during pregnancy provided important protection for the infant in the first few months of life before infants are eligible for vaccination.”
  • The American Medical Association shares what doctors wish their patients knew about social drivers of health.

From the U.S. healthcare business front,

  • Bloomberg reports
    • “We’re seeing wide price variation even in the same hospitals on the same day based upon the negotiated prices by the differing health insurance carriers or health plans,” said Cynthia Fisher, founder and chairman of the philanthropic group Patient Rights Advocate, , which provides free price data for nearly all of the more than 6,000 hospitals in the US. “For the employers, this is eye-opening.”
    • “Patient Rights Advocate on Dec. 11 introduced a hospital pricing search tool for the public. The organization pointed to prices for an injection of cancer drug Rituximab at Rush University Medical Center in Chicago that ranged from $899.33 for the Cigna Basic/Premier medical plan for Rush employees administered through Allegiance Benefit Plan Management Inc. by the Cigna Group, to $9,260.13 for the Cigna One Health HMO.
    • “If they’re able to offer it at a tenth of the price, why should one employer pay 10 times more?” Fisher said.
    • “Cigna didn’t respond to a request for comment, and a spokesman for Rush said the hospital wasn’t “in a position to speak to something that specific so rapidly.”
    • “Being able to easily compare prices will protect health plans from billing errors and fraud by hospitals and insurers, Fisher said. “The employers and unions that design health plans will be able to benefit from being well-informed about their choices and decisions to seek the best quality of care at the lowest possible prices,” she said.
  • Beckers Hospital Review identifies the thirteen out of twenty most popular prescription drugs that are in shortage and the 25 largest health systems by number of physicians.
  • Healthcare IT News calls attention to the fact that “Now that telemedicine is mainstream, artificial intelligence is helping healthcare providers with imperatives such as patient triage. Early results are promising.”
  • According to Reuters,
    • “High cost, logistical issues and the prospect of potential treatment advances are holding back adoption of the first gene therapies for hemophilia, experts said this week during the American Society of Hematology’s (ASH) annual meeting.
    • “Experimental options discussed at the San Diego meeting included personalized treatments and next-generation gene therapies, many still in the earliest stages of testing.”
  • Benefits Pro lets us know about a “Cigna report [that] outlines the benefits, challenges of value-based care. The Cigna paper suggests that physicians, patients, and health plans tend to recognize the good aspects of VBC, but that change has been slow nonetheless in the private sector.”
  • Per Fierce Healthcare,
    • “Kroger is piloting value-based primary care clinics as it joins a growing list of retailers looking to cash in on the booming sector of senior-focused medical care.
    • “The grocery chain has teamed up with Better Health Group, a provider network, to shift some of its in-store clinics, called The Little Clinic, into primary care centers for seniors, in addition to offering regular services.
    • “Better Health Group is rolling out the value-based model at eight of Kroger’s Altanta-area stores.
    • “The clinics today provide a full range of services from your acute, convenient care to primary care-like functions. About 60% of patients that we see in the clinic don’t have an assigned or designated primary care provider. So, there’s a huge opportunity just in general to serve patients and provide longitudinal care,” said Jim Kirby, chief commercial officer for Kroger Health, in an interview with Fierce Healthcare.”

Friday Factoids

David Ermer–FDA, HSA, Medical / Rx research, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

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

In Food and Drug Administration news,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.” 

Midweek update

David Ermer–CDC, Congress, COVID-19, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
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 failure, peripheral 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.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Hill reports,
    • “Congress is struggling to lock down a deal on government funding with just days until lawmakers are set to leave town for the rest of the year, as both chambers appear to have given up on passing their own spending bills.
    • “Lawmakers had been hopeful leadership would strike a deal last week on an overall top-line level for government funding in fiscal 2024 as part of the annual appropriations process. But as negotiations continue, lawmakers say leadership is cutting it close. Congress is staring down a shutdown deadline next month, with little legislative time on the calendar.” 
  • Healthcare Dive explains the features of the Lowers Costs, More Transparency bill passed last night by the House of Representatives. The wide bi-partisan margin supporting the bill gives it more likelihood of success in the Senate.
  • American Hospital Association News tells us,
    • “The House Dec. 12 voted 386-37 to pass AHA-supported legislation (H.R. 4531) that would reauthorize key SUPPORT Act programs for patients with substance use disorder and permanently extend required Medicaid coverage for medication-assisted treatments. The Senate Health, Education, Labor & Pensions Committee today advanced its own SUPPORT Act reauthorization bill (S. 3393).”
  • Healthcare Dive informs us,
    • “Nationwide health data exchange under TEFCA, the Trusted Exchange Framework and Common Agreement, is now operational, the HHS’ Office of the National Coordinator for Health Information Technology announced on Tuesday.
    • “Five Qualified Health Information Networks, or QHINs, completed the onboarding process and are ready for data exchange: eHealth Exchange, Epic Nexus, Health Gorilla, KONZA and MedAllies.
    • “The go-live marks a significant milestone that’s been years in the making, HHS leaders said at a signing event. “I feel like we’re watching the Big Bang occur in 2023,” said Secretary Xavier Becerra.”
  • Yippee! Now, true interoperability begins. Bye, bye fax machines.
  • HHS also announced,
    • “release[ing] HHS’s National Plan to Address Alzheimer’s Disease: 2023 Update – PDF. The National Plan is a roadmap of strategies and actions of how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors. It highlights the progress made in 2023, which was an historic year for the treatment of Alzheimer’s disease and related dementias (ADRD) and care for people with this condition.”
  • The U.S. Preventive Services Task Force is proposing to retain its Grade B recommendation that
    • “Clinicians provide or refer children and adolescents age six years or older with a high body mass index (BMI) (≥95th percentile for age and sex) to comprehensive, intensive behavioral interventions.”
    • The public comment period is open until January 16, 2024.
  • MedPage adds that
    • “To reap the “moderate net benefit,” kids should have 26 or more contact hours with the behavioral interventions for up to a year, [the USPSTF] advised.
    • “USPSTF fell short of recommending pharmacologic therapy, citing a lack of evidence. This did not mean the group recommended against this type of treatment; however, behavioral interventions should be the primary effective intervention for kids’ weight loss, the task force said.”
  • The CDC offers five healthy eating tips for the holidays.
  • The GAO issued a report on the rocky implementation of the No Surprises Act’s independent dispute resolution process.

From the public health and medical research front,

  • Beckers Hospital Review points out the fifteen states (and New York City), up from ten the previous week, with the highest rates of respiratory disease.
    • “Two states — Louisiana and South Carolina — reported “very high” respiratory virus activity levels. Thirteen states — Alabama, California, Colorado, Florida, Georgia, Mississippi, Nevada, New Jersey, New Mexico, North Carolina, Tennessee, Texas and Wyoming — and New York City reported “high” activity levels, which are a measure of the weekly percentage of visits to an outpatient healthcare provider or emergency department for fever and cough or sore throat.” 
  • Per STAT News,
    • “The sickle cell community has for the past few days been buzzing with news of the first-ever approved gene therapies for the devastating disease. Meanwhile, researchers at the American Society of Hematology meeting on Tuesday are reporting advances in a less expensive and more established strategy proven to cure patients: bone marrow transplant.
    • “This approach has been around for decades but required patients to have a well-matched donor and endure a hefty dose of chemotherapy, ruling out transplant as an option for the vast majority of patients. In a mid-stage trial, however, researchers said sickle cell patients who were given a gentler course of chemo and an infusion of half-matched cells fared well: They had less pain, and 95% of participants were alive two years after transplant and only 7% of recipients experienced a severe reaction caused by transplanted immune cells attacking their new home.”
  • and
    • “One of the toughest subtypes of acute leukemia involves a genetic alteration in the KMT2A gene. Many cancers with this genetic alteration end up relapsing or don’t respond to treatment, but new data presented at the annual American Society of Hematology meeting offer hope of a new targeted therapy for these patients.
    • “The study, called the Phase 2 Augment-101 trial, tested Syndax’s revumenib in patients with relapsed or refractory leukemia with these KMT2A genetic rearrangements. Overall, about 63% of the patients responded to the treatment, with many able to receive a potentially curative stem cell transplant later on, which is often the ultimate goal for patients with relapsed or refractory patients, said Ibrahim Aldoss, a hematologist-oncologist at City of Hope and the study’s presenter, in an interview.”
  • The New York Times asks why since 2009 pedestrian deaths at night continue climb?
    • “[P]ut together, it’s clear that there’s been a particularly American mix of technological and social changes over the past decade and a half. And they have all come on top of a road system and an ingrained culture that prioritizes speed over safety. Whatever has happened over this time has reversed years of progress on daytime pedestrian fatalities, too, leading to a modest increase in deaths. Nighttime, however, has the potential to amplify so many of these new risks.
    • “A transportation system that’s safer by design — as in many European countries — might better absorb any one of these dangers. Distracted drivers are safer at lower speeds. People out at night are safer with well-lit crosswalks.”
  • The New York Times furthermore reports,
    • “Zepbound, the newly approved weight loss drug, hit the market this month. People seeking out the medication may have to stay on it for the foreseeable future — potentially, for the rest of their lives — if they want to keep the weight off, new research confirms.
    • “A study published Monday followed 670 people who had taken tirzepatide, the compound in Zepbound and the diabetes drug Mounjaro, for 36 weeks. Eli Lilly, the company that makes both drugs, funded the study. Tirzepatide regulates insulin levels and slows down the emptying of the stomach. It also acts on areas of the brain that control hunger and appetite. As a result, people can lose significant weight: On average, the study participants lost around 20 percent of their body weight during that time.
    • “After that, half of the participants continued to take a high dose of tirzepatide for a year while the other half received a placebo shot. Those in the study also underwent lifestyle counseling, ensuring that they were eating fewer calories and exercising regularly.
    • “People who continued taking tirzepatide for an additional year lost, on average, another 5.5 percent of their body weight. Those who were switched to the placebo, however, gained 14 percent of their body weight on average. Those on the placebo also tended to have higher cholesterol, blood sugar and blood pressure than they did while taking tirzepatide, said Dr. Louis Aronne, the lead author on the study and the director for the Comprehensive Weight Control Center at Weill Cornell Medicine.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Optum Rx is launching a new weight management program aimed at improving outcomes and addressing affordability.
    • “The cost of GLP-1 drugs amid continued high demand is a key focus for pharmacy benefit managers and plan sponsors, especially as individual therapies can top $10,000 per year. Through the Optum Rx Weight Engage program, the PBM is aiming to support employers and other clients in designing benefits for their membership.
    • “The team will review the client’s goals to build a tailored program that will deploy clinical solutions as well as patient monitoring and motivation and support tools, the company said. Members can connect to an obesity management specialist who will direct them to the appropriate clinical services.”
  • Healthcare Dive reports,
    • “Healthcare prices typically rise faster than inflation, but 2023 may have bucked that trend.
    • “The cost of shoppable medical services at hospitals increased 2% in the first three quarters of the year, according to new data from Turquoise Health released Tuesday. That’s in line with the 1.9% overall growth of the economy.
    • “The findings — some of the first from new price transparency data disclosing the once-secret negotiated rates between health insurers and providers — illustrate how overall economic inflation could be catching up to faster health cost growth.”
  • STAT News notes,
    • “In its latest bid to police the pharmaceutical industry, the U.S. Federal Trade Commission sought to block Sanofi from licensing a Pompe disease treatment made by another drug company. And in response, Sanofi is ending the deal.
    • “Sanofi sought the rights to the medication from Maze Therapeutics, but the regulator argued the deal — valued at $775 million — would eliminate a “nascent competitor” that could, otherwise, challenge the monopoly Sanofi has in the market for Pompe disease treatments, according to an FTC statement. The agency had filed a complaint in a federal court in Boston and also planned to seek a preliminary injunction.”
  • BioPharma Dive adds,
    • “The scuttled deal came on the same day that the regulator gave final clearance to Pfizer’s $43 billion acquisition of Seagen, which had faced close scrutiny from the antitrust regulator. To ease the FTC’s concerns, Pfizer has agreed to donate royalties from sales of the cancer drug Bavencio to the American Association for Cancer Research.”
  • Beckers Hospital Review points out six innovative hospitals.
  • According to BioPharma Dive,
    • “AstraZeneca on Tuesday reached a deal to acquire vaccine developer Icosavax in a deal worth up to $1.1 billion. 
    • “Per deal terms, AstraZeneca will acquire Icosavax’s shares at $15 apiece, and could add another $5 per share to the buyout if certain milestones and sales targets are met. The upfront payment from AstraZeneca represents an equity value of about $838 million and a premium of about 43% to Icosavax’s closing price on Monday. The acquisition would reach $1.1 billion if AstraZeneca eventually makes the future payouts, which are known as “contingent value rights.”  
    • “Icosavax has been developing an experimental shot that simultaneously targets respiratory syncytial virus and human metapneumovirus, another lung infection. The biotech released Phase 2 study results on Tuesday showing the vaccine spurred an immune response against both viruses without causing any serious adverse events. AstraZeneca will now take over late-stage development, and, if successful, commercialization.”  

Monday Roundup

David Ermer–CDC, Congress, COVID vaccine mandate, Generative AI, Rx coverage, SCOTUS, U.S. Healthcare–
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.” 

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.”