Monday Roundup

Rx coverage

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they made in cases involving the federal government employee Covid vaccine mandate on the ground that the President had withdrawn the mandate.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.” 

Friday Factoids

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Happy Hanukkah

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

From Washington, DC,

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

In federal benefit news,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Hugo Clément on Unsplash

From Washington, DC

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

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Tidbits

David Ermer–AHRQ, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • The Medicare open enrollment period ends on Thursday, December 7. The Federal Benefits Open Season ends next Monday, December 11. While the Affordable Care Act open enrollment period continues into next month, December 15 is the last day to enroll if you want your coverage to begin on January 1, 2024.
  • FEHB open season changes take effect on January 1, 2024, for annuitants and on January 14, 2024, for federal employees. January 14 is the beginning of the first pay period in 2024.
  • Govexec tells us,
    • “In a memo to agency heads on Friday, OPM Associate Director for Workforce Policy and Innovation Veronica Hinton announced that the government’s HR agency had added shared certification functionality to the agency-facing portion of USAJOBS through a tool called Talent Pools.
    • “The Office of Personnel Management is proud to announce a new USAJOBS feature, Talent Pools, to ‘advertise’ available shared certificates of candidates across government,” Hinton wrote. “These certificates, issued under delegated examining procedures through the Competitive Service Act or an OPM-run cross government hiring action, contain candidates who have applied to an open announcement, have been assessed and are available for agencies’ consideration.”
    • “Hinton argued that the new feature should be a boon to agency hiring managers and job applicants alike by removing unnecessary and often duplicative red tape.”
  • Federal News Network informs us,
    • “Federal employees working in cyber now have a way to develop skills, while also seeing what it’s like to work at another agency.
    • “In the hopes of boosting retention of cyber employees, the Office of Personnel Management launched a new platform Monday for agencies to advertise openings in the cyber workforce rotation program.
    • “The rotation program lets agencies offer temporary assignments to federal employees who are currently working in IT, cyber or cyber-related positions in government. Eligible employees can apply for and work at a different agency for between six months and one year before returning to their home agency.
    • “The cyber rotations will advance career opportunities and support employee engagement, satisfaction and retention,” OPM said.”
  • The U.S. Preventive Services Task Force released two draft recommendation statements for public comment.
    • “Grade B — The USPSTF recommends exercise interventions to prevent falls in community-dwelling adults age 65 years or older who are at increased risk for falls.
    • Grade C — The USPSTF recommends that clinicians individualize the decision to offer multifactorial interventions to prevent falls to community-dwelling adults age 65 years or older who are at increased risk for falls. Existing evidence indicates that the overall net benefit of routinely offering multifactorial interventions to prevent falls is small. When determining whether this service is appropriate for an individual, patients and clinicians should consider the balance of benefits and harms based on the circumstances of prior falls, presence of comorbid medical conditions, and the patient’s values and preferences.”
    • The public comment period on the draft recommendation statements and the related draft evidence reviews ends on January 8, 2024. These recommendations would continue the current grades for these recommendations, last issued in 2018.

From the public health and medical research front,

  • Per Beckers Hospital Review,
    • “Leapfrog is winding down 2023 by recognizing 132 hospitals with its Top Hospital Award, a distinction for hospitals that demonstrate the highest performance in the U.S. on quality and patient safety. 
    • “Awarded hospitals are divided into four groups: general hospitals (34), children’s hospitals (8), rural hospitals (15) and teaching hospitals (75). Methodologies for the awards in each category can be found here. Seventeen more hospitals were awarded this year compared to last.”
    • The article lists all 132 recognized hospitals by state.
  • and
    • United Health Foundation released its 2023 America’s Health Rankings Dec. 5, which analyzes the overall health of the 50 states and this year identifies a record-high and rising prevalence of chronic conditions. 
    • For the 2023 rankings, UHF analyzed 87 measures across five categories of health: social and economic factors, physical environment, behaviors, clinical care and health outcomes. This year, eight chronic conditions — arthritis, depression, diabetes, asthma, cancer, cardiovascular diseases, chronic obstructive pulmonary disease and chronic kidney disease — reached their highest levels since America’s Health Rankings began tracking these measures in 1990. 
  • STAT News reports,
    • “Given the widespread acceptance that the current flu vaccines could use improvement, are mRNA shots the answer? As the scientific world waits for published data on which to formulate conclusions, STAT spoke to influenza and vaccine experts who see some significant benefits of applying mRNA technology to the production of flu vaccine — but also some serious challenges mRNA manufacturers will face breaking into this already crowded market.” 
    • In short, it’s messy.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health, the nation’s largest drugstore chain, will move away from the complex formulas used to set the prices of the prescription drugs it sells, shifting to a simpler model that could upend how American pharmacies are paid. 
    • “Under the plan, CVS’s roughly 9,500 retail pharmacies will get reimbursed by pharmacy-benefit managers and other payers based on the amount that CVS paid for the drugs, in addition to a limited markup and a flat fee to cover the services involved in handling and dispensing the prescriptions. Today, pharmacies are generally paid using complex measures that aren’t directly based on what they spent to purchase specific drugs.
    • “A similar payment model, sometimes known as “cost plus,” has been promoted by entrepreneur Mark Cuban’s eponymous pharmacy company, among others, which have said it brings greater clarity and accountability to drug pricing.  * * *
    • “The company will call the payment model CostVantage. When it starts rolling out next year, the new prices will first become available to consumers paying cash for their prescriptions using an array of drug discount cards. 
    • “In 2025, the setup will be incorporated into CVS pharmacies’ contracts with pharmacy-benefit managers covering drugs paid for under employer plans.
    • “CVS will also introduce a new option for clients of its PBM, CVS Caremark, that will work in tandem with the new retail pharmacy-payment scheme. The new PBM product, called TrueCost, will be based on the net cost of drugs with defined fee structures, the company said. Employers and other clients will have the choice to use it or not.”
  • Fierce Healthcare adds,
    • “After spending nearly $20 billion to pick up Signify Health and Oak Street Health this year, CVS rebranded its health services business to “CVS Healthspire” as it plots its long-term growth strategy.
    • “During the Forbes Healthcare Summit in New York City on Monday, CVS chief executive officer Karen Lynch said Healthspire will encompass CVS’ pharmacy services business, its care delivery assets, including home health company Signify Health and Medicare-focused primary care player Oak Street Health, as well as its new Cordavis operation. Cordavis is a new segment CVS launched in August that aims to work with drugmakers to bring additional biosimilars to market.”
  • BioPharma Dive points out,
    • “Johnson & Johnson expects its pharmaceuticals division will bring to market 20 new therapies for cancer, immune and neurological diseases by 2030, an outlook that underpins the industry giant’s forecast for sales growth of between 5% and 7% through the end of the decade.
    • “Seven of those anticipated drugs have the potential to earn more than $5 billion each in peak annual sales, J&J said Tuesday as part of a business review held three months after the company split off its consumer division. The separation left J&J slimmer, but focused on its higher-margin pharmaceuticals and medical device businesses.
  • Per Healthcare Dive,
    • “Next year is set to be another “make or break” year for nonprofit hospitals as they continue to weather staffing shortages and heightened inflation, according to a report from credit ratings agency Fitch Ratings released on Tuesday.
    • “The outlook for the sector is still “deteriorating” — a rating that’s been in place since August 2022. Fitch does not forecast credit downgrades en masse in the coming year. However, downgrades and negative outlooks will likely continue to outpace upgrades and positive outlooks.
    • “The single largest differentiator in performance will be hospitals’ ability to attract and retain staff in a hypercompetitive landscape, said Kevin Holloran, Fitch senior director and sector head, in a statement.” 

Post Thanksgiving Extra

David Ermer–No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

The FEHBlog noted his plan on Wednesday to hold off on future posts until Cybersecurity Saturday. A pleasant Thanksgiving holiday resulted in the FEHBlog preparing this Friday Extra.

From Washington, DC,

  • CMS issued a No Surprises Act toolkit for consumer advocates.
  • Federal News Network tells us,
    • “As it’s the middle of open season, those eligible have until Dec. 12 to enroll or make changes to their plans under TRICARE – the Defense Department’s healthcare system – for 2024.
    • “The two main plans eligible for enrollment are TRICARE Prime, which includes the U.S. Family Health Plan, and TRICARE Select. TRICARE Open Season does not apply to its premium plans – TRICARE Young Adult, TRICARE Reserve Select and TRICARE Retired Reserve. TRICARE Open Season also does not apply to those who are eligible for Medicare or those using TRICARE For Life. It also does not apply to active duty service members. These groups do not have to do anything during the Open Season.
    • “Open Season is an opportunity for you to evaluate the health care coverage that your family has and to see if you need to change plans or if you want to stay in the current plan that you’re in,” Zelle Zim, who’s on TRICARE’s policy and programs team, said at a TRICARE event on Wednesday. “You also have the opportunity to enroll in a new plan during TRICARE Open Season.”

In public health and medical research news,

  • Healthcare Dive informs us,
    • “Rates of completion for high-risk diagnostic tests and referrals were lower when ordered during a telehealth visit compared with an in-person appointment, according to a study published in JAMA Network Open. 
    • “For telehealth orders, 43% were completed during the designated time frame compared with 58% of tests and referrals requested during in-person appointments, and 57% of those ordered without any visit at all. 
    • “Failure to get tests or complete referrals is a leading cause of diagnostic errors, and safety risks can be a particular concern in primary care due to the large number of potential diagnoses, researchers said.” 
  • STAT News points out,
    • “Overdose deaths among pregnant or postpartum people skyrocketed between 2018 and 2021, according to new research published Wednesday in JAMA Psychiatry.
    • “The study, conducted by the National Institute on Drug Abuse (NIDA) and the National Institutes of Health, compared the incidence of maternal deaths for overdose of commonly misused psychotropic drugs (such as heroin and other opioids, including synthetic ones, or cocaine) among girls and women aged 10 to 44.
    • “The spike in overdose deaths was especially high among women ages 35 to 44. In 2018, the rate was 4.9 overdose maternal deaths per 100,000 mothers with a live birth; in 2021, the rate was 15.8 per 100,000. The rate of overdose death for all age groups also increased significantly, from 6.9 per 100,000 mothers in the first half of 2018 to 12.2 in the second half of 2021.”
  • Beckers Hospital Review reports, “There’s been a slight slowdown in reports of new drug shortages before the winter holiday season, but six medications recently entered the list of ongoing shortages, which includes about 300 drugs.” Becker’s article lists those six drugs.

From the U.S. healthcare business front,

  • Beckers Payer Issues notes that Blue Cross licensees are “diving into” direct healthcare delivery. “BCBS plans have spent 2023 reorganizing to better compete with larger insurers through corporate restructuring, M&A or the launch of healthcare delivery subsidiaries.”
  • Per Fierce Healthcare,
    • “Pharmacy benefit management giant Optum Rx is aiming to address maternal and fetal health by leaning on the power of independent pharmacies.
    • “The Road to Healthy Baby program launched earlier this year in three states—Louisiana, Michigan and New Mexico—and offers pregnant patients prenatal checkups and vitamins at an independent pharmacy. The initiative is part of a broader push by the PBM that seeks to harness the power of these pharmacies.
    • “Through the program, a pregnant person who maintains their prenatal vitamins across three prescriptions or a 90-day supply will receive a care kit with key items that help during pregnancy and after the baby is born.
    • “Optum has also deployed grants to local diaper banks to ensure new mothers have access to necessary supplies. Katie McCarey, vice president of pharmacy strategy and product innovation at Optum Rx, told Fierce Healthcare that the company has found in some markets that new mothers often have just one or two diapers available each day for their babies.”
  • and
    • “UPMC’s operations dipped into the red this quarter as volumes and their associated care delivery costs and insurance claims continue to climb.
    • “The Pittsburgh-based integrated nonprofit system reported Tuesday a $191 million operating loss (-2.8% operating margin) and a $421.8 million change in net assets (without donor restrictions) for the three months ended Sept. 30. During the same time a year prior, UPMC had logged a $114.5 million operating income (1.8% operating margin) and $272.6 million drop in its net assets (without donor restrictions).
    • “The organization is now sitting at a $176.5 million operating loss (-0.9%) year to date despite its strong start to 2023. Its bottom line reflects a $244.7 million net decline over nine months.
    • “In a release announcing the financial results, UPMC Executive Vice President and Chief Financial Officer stressed that the system is “staying to true its commitments” surrounding capital investments ($517 million year to date) despite industry-wide workforce challenges and other headwinds.”
  • Healthcare Dive highlights five major healthcare company bankruptcy filings in 2023. “Bankruptcies have spiked this year as federal COVID-19 funding lapsed and heightened interest rates, regulatory changes and labor shortages squeezed the sector.”

Tuesday Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Roundup

David Ermer–Congress, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Hill reports,
    • “Senate Majority Leader Chuck Schumer (D-N.Y.) on Monday said he is “pleased” with Speaker Mike Johnson’s (R-La.) plan to avoid a government shutdown.
    • “Schumer noted that Johnson’s “laddered” stopgap spending bill — which funds four bills through Jan. 19 and the remaining eight through Feb. 2 — is “far from perfect,” but indicated the “clean” measure provides a path to funding the government for the next two months.”
  • The Department of Health and Human Services tells us,
    • “Today, amid new data released on substance use across the nation, the Biden-Harris Administration reiterated President Biden’s clear and urgent call for Congress to provide critical additional resources to strengthen addiction treatment and crack down on drug trafficking.
    • “Today’s new data from the 2022 National Survey on Drug Use and Health (NSDUH) show there were more than 48 million Americans who experienced a substance use disorder in 2022. Of the 48 million Americans struggling with substance use disorder, three out of every four did not get treatment. While the Biden-Harris Administration has made historic progress in expanding access to life-saving public health services and stopping the flow of illicit drugs like fentanyl into American communities, the nation is facing an unprecedented epidemic that requires the full support and funding of Congress.”
  • Govexec informs us,
    • “The Office of Personnel Management on Thursday released new guidance spelling out ways that federal agencies can implement a recent executive order aimed at making it easier for military spouses to have a career in public service. * * *
    • “In a memo to agency heads, OPM Director Kiran Ahuja said the government’s forthcoming strategic plan for hiring and retaining military spouses will be released later this year. But in the meantime, she offered a few avenues where agencies can take action now to improve their performance on the issue.”

In FEHB news, The Federal Times, Govexec, Federal News Network, and FedSmith offer advice to participants in the Federal Benefits Open Season.

From the public health and medical research front,

  • The New York Times reports,
    • “The gap in life expectancy between men and women in the United States grew to its widest in nearly 30 years, driven mainly by more men dying of Covid and drug overdoses, according to a new study in The Journal of the American Medical Association.
    • “In 2021, women had a life expectancy of 79.3 years, compared with 73.5 years for men, the study found.
    • “It was unsettling to see,” said Dr. Brandon Yan, a resident physician at the University of California, San Francisco, and lead author of the study, which analyzed death data from the Centers for Disease Control and Prevention.
    • “We need to understand which groups are particularly losing out on years of life expectancy so interventions can be at least partially focused on these groups,” Dr. Yan said.”
  • STAT News adds,
    • “The decline in life expectancy in the U.S. suggests that advancements in medical treatment are no longer sufficient to counter ongoing public health crises, Yan said. “We have a health care system that is very advanced in treating illnesses and advanced disease. But for the most part … it is not very good when it comes to preventative care.”
  • FEHBlog note — The English were tracking life expectancy in the late 1600s.
  • Last week, the Times of London reported,
    • “Thousands of women will avoid suffering breast cancer after a pill that costs 4p a day was approved as a preventive treatment for the disease.
    • “Almost 300,000 women at higher risk will be eligible for anastrozole, which studies have shown can nearly halve the chances of developing breast cancer if taken daily for five years.
    • “Campaigners hailed the approval as a “major step forward” in efforts to tackle the disease, which is Britain’s most common cancer, with 47,000 new diagnoses each year. Until yesterday, anastrozole had been licensed for use in Britain only as a treatment, rather than a preventive measure.
    • “NHS England said 289,000 women in their 50s and 60s at moderate or high risk of breast cancer would now be eligible for the drug. They will include women with a family history of the disease, or who have faulty genes such as BRCA1, the so-called Jolie gene, that put them at greater risk.”
  • STAT News adds today,
    • “Like the better-known tamoxifen, anastrozole was first used to treat breast cancer. Then, because risk doesn’t end with treatment, the hormone-blocking drug was also prescribed to prevent cancer’s return. Ten years ago, after a clinical trial showed convincingly that the drug could prevent breast cancer, U.S. oncologists began prescribing it off-label. In the U.K., anastrozole got the nod for this use last week from the country’s Medicines and Healthcare products Regulatory Agency. * * *
    • “The two drugs approved by the U.S. Food and Drug Administration for prevention, tamoxifen and raloxifene, reduce estrogen in different ways but offer the same kind of protection. Brewster said they are used more often in the U.S. than anastrozole, possibly because of milder side effects. * * *
    • “These prevention drugs themselves are not without risk. As [Dr. Abenaa] Brewster [a professor of clinical cancer prevention at MD Anderson Cancer Center] puts it, there’s no such thing as free lunch, and when patients are healthy, their tolerance for side effects is understandably lower than when they are in treatment for active disease. Most women tolerate tamoxifen well, but there are rare side effects of uterine cancer or blood clots. Some patients taking anastrozole and raloxifene experience joint stiffness, vaginal dryness, hot flashes, or bone thinning.”
  • The New York Times Morning column observes,
    • “The changing nature of the drug crisis was predictable, because drug use is historically faddish. In the 1970s, America struggled with heroin. In the ’80s, it was cocaine. In the ’90s and early 2000s, meth. Since then, opioids have taken off.
    • “One explanation for this is what’s known as generational forgetting: Young people tend to avoid the drug that is currently causing a crisis. But because they don’t have personal experiences with the drugs that caused harm before their time, they are more willing to use those substances.
    • “Different drugs can also complement each other, and so their popularity can rise simultaneously. Opioids, for example, often cause users to doze off, which can leave those who live on the streets vulnerable to theft or rape. So opioid users sometimes use stimulants, like meth and cocaine, to stay awake. And if they receive treatment for opioid addiction, they may continue using stimulants.
    • “All of this leads to a revolving door for different kinds of drug crises. It has happened before, and it is happening again.
    • “Read Jan’s full story, which includes details about the rise of a kind of meth so pure that some are calling it “super meth.”
  • Mercer Consulting offers a Q&A about weight loss medications with their pharmacy team.
    • Do these medications have an ROI? When might plan sponsors expect to see benefits from treating obesity as a chronic disease?
    • Jon Lewis, Mercer Rx Financial Leader:  These medications represent a big investment. While everyone talks about the high list prices, it is worth noting something fairly unique here. We do have manufacturer competition which means rebates are playing a role and should be monitored.  
    • In general though, we are looking at somewhere between three to five years before you start to realize any savings. Those who are at higher risk – for example, people with a higher BMI – are likely to produce more savings. With that said, changing eligibility to a narrower BMI does have a rebate impact and should be incorporated into any weight loss strategy. 
    • But these drugs are costly. You would have to have someone who is on the drug long enough to achieve the weight loss, still be employed, and still be maintaining that weight loss over the course of three to five years to see an ROI or some form of savings. 
  • Beckers Hospital Review discusses rural hospitals’ maternity care crisis.
  • Per MedPage Today,
    • “Peanut-allergic toddlers who stayed on an investigational, epicutaneous immunotherapy skin patch reached higher levels of peanut tolerance during the second year, according to the open-label extension of the EPITOPE trial.”Peanut-allergic toddlers who stayed on an investigational, epicutaneous immunotherapy skin patch reached higher levels of peanut tolerance during the second year, according to the open-label extension of the EPITOPE trial.”

From the U.S. healthcare business front,

  • MedTech Dive points out,
    • “More complete data from a clinical trial of Novo Nordisk’s Wegovy weight loss drug have rekindled the debate over how the treatment will affect patient demand for medical devices and procedures.
    • “The findings from the SELECT study, presented at a major heart meetingover the weekend, showed a 20% reduction in risk on a composite goal of heart attack, stroke or cardiovascular death, compared to a placebo, in overweight and obese patients with heart disease. But the data were inconclusive on a narrower measure of cardiovascular death alone.
    • “The data overall confirm a cardiovascular benefit for patients, but mixed results on secondary endpoints do not alter the outlook for heart device makers such as Boston Scientific, Medtronic and Edwards Lifesciences, Mizuho analyst Anthony Petrone said Monday in a report to clients.”
    • “At first blush, we see the final SELECT data as neutral for cardiovascular names,” he wrote.
  • BioPharma Dive informs us,
    • “Novartis is deepening its investment in cancer cell therapy, licensing an experimental project developed by Legend Biotech that is in early-stage trials for two types of lung cancer, the smaller company said Monday.
    • “Novartis will pay Legend $100 million upfront to secure rights to the cell therapy, called LB2102, and could send Legend up to $1 billion more if clinical, regulatory and commercial milestones are met. Legend will complete Phase 1 testing, after which Novartis will assume development responsibilities.
    • “Legend said Novartis may use in its development plan its new T-Charge manufacturing platform, which aims to reduce the time it takes to make cancer-fighting cells outside the body as well as improve their durability. Cell therapies like Novartis’ Kymriah can induce long-lasting responses in patients, but they require a weeks long manufacturing process that carries the risk of failure or patient progression.”

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

The FEHBlog is back in DC for the workweek. So let’s get started with news from the Washington, DC, front,

  • The continuing resolution funding the federal government expires on Friday, November 17.
  • The Wall Street Journal reports,
    • “House Speaker Mike Johnson (R., La.) unveiled a two-step short-term spending proposal that would keep money flowing to federal agencies into early next year, in a bid to stave off a partial government shutdown late [this] week. 
    • “* * * According to a document obtained by The Wall Street Journal, if the two-step plan doesn’t pass, House Republicans will turn to what they call a full-year continuing resolution, keeping spending flat—although it would contain “appropriate adjustments to meet our national security priorities.” * * *
    • “The announcement marks a major test for Johnson, who now needs to sell the plan to House Republicans, a group that has been hard to unify on federal spending. Republicans have a 221-212 majority, with Rep. Gabe Amo of Rhode Island, a Democrat, yet to be sworn in after winning an open seat.”
  • OPM.gov reminds us that the Federal Benefits Open Season begins at midnight November 13. The Open Season ends on December 11, 2023.
  • MedPage Today notes,
    • A proposed federal policy aims to protect older Americans from contracting HIV by offering free preventive medication, the latest effort to catch up to much of Europe and Africa in stemming the spread of the virus.
    • Under the plan from the Biden administration, Medicare would cover patients’ full cost of pre-exposure prophylaxis (PrEP) drugs, which prevent HIV transmission. The drugs would be free in pill form and — for the first time — as long-acting injectables through the government insurance program designed for those 65 and older. Those 50 and over make up half of all people in the U.S. already living with HIV.
  • The FEHBP and other group health plans have been covering PrEP since at least 2020.
  • The Washington Post informs us,
    • “Publishing in the journal Health Affairs, researchers looked at data from the Health Professional Shortage Area (HPSA) program, zeroing in on physician density and mortality. Introduced in 1965, the HPSA program designates areas in need of more physicians and offers bonuses, loan repayment, visa waivers, higher reimbursements and other benefits to doctors who choose to practice and serve Medicare patients in specific communities.
    • “The researchers analyzed outcomes in HPSAs and areas without the designation between 1978 and 2015, matching 844 shortage counties with similar counties with enough providers. Using a variety of statistical methods designed to sift through dense demographic factors, the analysis yielded few clues that HPSA leads to higher physician numbers or reduces deaths. Some small effects were seen, but the changes were statistically insignificant, the researchers write.”

From the public health and medical/drug research front,

  • STAT News tells us,
    • [Novo Nordisk (Novo0] in August had announced that in this trial, called Select, Wegovy reduced the overall rate of major heart problems — heart attacks, stroke, or cardiovascular-related death — by 20%. That finding, which was the primary outcome the trial set out to study, was stronger than many were expecting and led Novo’s stock to surge.
    • Novo’s obesity drug Wegovy notably cut the risk of heart attacks in a landmark cardio-vascular trial that affirms the treatment offers health benefits beyond weight loss. * * *
    • But details of the study, including risk reductions for each specific heart complication, were not released until Saturday when they were presented here — before a standing-room-only crowd — as the first major session of the American Heart Association conference. 
    • The overall 20% risk reduction in heart problems translated to 15 complications prevented for every 1,000 patients treated.
    • Wegovy specifically cut the rate of heart attacks by 28% among patients who were already taking statins and other medications to prevent heart problems, according to the results, simultaneously published in the New England Journal of Medicine. The drug also reduced the rate of cardiovascular-related deaths by 15% and strokes by 7%.
  • Per NPR Shots,
    • “For the first time, researchers have produced evidence that gene-editing can cut high cholesterol, a major risk factor for the nation’s leading killer.
    • “Preliminary results from a study involving ten patients born with a genetic condition that causes very high cholesterol found that editing a gene inside the liver can significantly reduce levels of “bad cholesterol.”
    • “The experimental treatment needs to be tested on more patients who would be followed for much longer to confirm the approach is safe and effective. But the results are being hailed as a potential landmark proof-of-concept that could eventually provide a powerful new way to prevent heart attacks and strokes.
  • The New York Times reports,
    • “A new antibiotic, the first to be developed in decades, can cure gonorrhea infections at least as effectively as the most powerful current treatment, a large clinical trial has found. The drug, zoliflodacin, is taken as a single dose, and it has not yet been approved for use in any country.
    • “But the drug was developed in a way that experts hope will make it widely accessible and will prevent widespread drug resistance. * * *
    • “Pharmaceutical companies have largely abandoned antibiotic development as unprofitable. The development of zoliflodacin represents a new model: G.A.R.D.P., which is funded by many Group of 20 countries and the European Union, developed the drug in collaboration with an American pharmaceutical company called Innoviva Specialty Therapeutics.
    • “The nonprofit sponsored the Phase 3 trial of the drug. In exchange, it holds the license to sell the antibiotic in about 160 countries, while Innoviva retains marketing rights for high-income countries. 
    • “I’ll go out on a limb and say that’s probably the only way in which we develop antibiotics going forward, because the old model is simply not going to work,” said Ramanan Laxminarayan, a senior research scholar at Princeton University who chairs the G.A.R.D.P. board.”
  • Nature adds,
    • “To forestall resistance to zoliflodacin, the drug is being developed only as a treatment for gonorrhea and other sexually transmitted infections (STIs). However, it will be up to regulatory and public health agencies to decide when and how the drug can be used.
    • “New diagnostics will also be important, says Teodora Wi, an STI specialist at the World Health Organization in Geneva. Tests that can rapidly distinguish gonorrhea from other STIs should be more widely available in the near future, but those able to identify drug resistance are further off. National surveillance programs for antibiotic-resistant gonorrhea could also guide the responsible use of zoliflodacin, Wi adds.”

From the U.S. healthcare business front,

  • Forbes reports,
    • “Weight loss prescriptions Wegovy, Rybelsus and Saxenda—along with diabetes drug Ozempic, often used off label for weight loss—are driving health costs for employers up by more than $300 per insured worker this year, new data from benefits consultancy Aon says.
    • “These GLP-1 drug costs are expected to boost healthcare spending through 2025, increasing from $324 per insured member this year up to $500 per insured health plan member in two years, new data from the benefits consultancy Aon says. By comparison, annual spending on such prescriptions in 2021 was $96 per member, Aon data shows.
    • “Employees, too, can expect higher co-payments, deductibles and premiums deducted from their paychecks because employers almost always shift part of their total premium costs onto workers, though this can vary widely depending on employer.
    • “Aon’s analysis comes from its Aon Rx claims data from nearly 500 employers and their 4.4 million health plan members. Aon said weight loss prescriptions Wegovy, Rybelsus and Saxenda have led the growth, with health spending contributions from Ozempic, which is approved to treat diabetes but is often prescribed off label by physicians for weight loss.”
  • Big money.

Happy Veterans’ Day

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

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

From Washington, DC,

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

From the public health and research front,

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

From the U.S. healthcare business front,

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