Friday Factoids

Friday Factoids

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From Washington, DC

  • The American Medical Association News informs us,
    • “The Departments of Health and Human Services, Labor and the Treasury Oct. 27 issued a proposed rule intended to improve how the No Surprises Act independent dispute resolution process functions in response to feedback and challenges shared by stakeholders. The public will have 60 days to submit comments. The rule would require plans to include claim adjustment reason codes and remittance advice remark codes, among other new information, with the initial payment or notice of payment denial for certain items and services subject to the NSA protections. The rule proposes changes to the batching requirements so that Items and services could be batched in the same payment determination if they are: furnished to a single patient on one or more consecutive dates of service and billed on the same claim form (a single patient encounter); billed under the same service code or a comparable code under a different procedural code system; or anesthesiology, radiology, pathology and laboratory items and services billed under service codes belonging to the same Category I CPT code section, as specified in the agencies’ guidance. Batched items would be limited to 25 items or services in a single dispute. Lastly, the proposed rule would amend certain requirements related to the open negotiation period preceding the IDR process, the initiation of the process, the dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees.”
  • The proposed rule will be published in the Federal Register next Friday, November 3, and the proposal creates a sixty-day public comment period.
  • Here’s a link to the government’s fact sheet on the proposed rule.
  • The FEHBlog noticed that the proposed rule would run open negotiations through the government’s IDR portal, which will increase the government’s administrative costs. It strikes the FEHBlog that the proposed rule could have established a process for the open negotiation for the parties to follow. The proposed rule will require health plan system changes, which is always expensive.
  • Also today, the Department of Health and Human Services wrote to stakeholders, including health plans, reminding them the cost of Paxlovid and other Covid drugs is shifting from the government to the private sector beginning on November 1.
  • STAT News reports,
    • “The Food and Drug Administration on Thursday approved an Eli Lilly drug that takes a new approach to treating ulcerative colitis, a chronic inflammatory disease that can cause intense gastrointestinal pain and distress.
    • “The therapy, dubbed Omvoh, is an antibody that blocks IL-23p19, an immune signaling molecule that plays a key role in sustaining the disease. It’s the first treatment to target this particular pathway in ulcerative colitis. The drug’s approval comes after two late-stage trials found that patients taking Omvoh showed a significant improvement in symptoms after both three months and a year compared with those given a placebo, and that the therapy had minimal side effects.
    • “Omvoh’s list price will be $9,593 per month for intravenous delivery and $10,360 per dose injected beneath the skin. A company spokesperson told STAT that patients who have the drug covered by commercial insurance may pay as little as $5 per month for up to 30 months.”

From the public health front,

  • Health Payer Intelligence points out,
    • “Americans are feeling more optimistic about their well-being than last year, but financial concerns and mental health challenges are still negatively impacting their health, according to a report from The Cigna Group.
    • “The second annual Vitality in America study reflects responses from 10,000 adults collected in June 2023 by Morning Consult. The study uses the Evernorth Vitality Index, a subjective measure of health and well-being, to assess Americans’ experiences with personal health, finances, and job satisfaction.
    • “Almost half of respondents said they look forward to each new day, up from 43 percent in 2022. However, fewer adults said they prioritize their physical health (39 percent), feel capable of managing their emotions (45 percent), and can financially support themselves (40 percent).
    • “The top driver of stress among US adults was finances (40 percent), followed by housing conditions (25 percent), work (25 percent), family or social relationships (25 percent), and health (24 percent).”
  • Per Fierce Healthcare,
    • “More patients are accessing their medical records online via patient portals or apps and are doing so more often than in years past, according to the Office of the National Coordinator for Health IT (ONC).
    • “From 2020 to 2022, the portion of U.S. adults who reported being offered access to their medical records by a provider or insurer increased 24% to about 3 in 5, the office wrote in a recent data brief. The percentage who said they were offered access and used it jumped 50% during the same period, from 38% to 57%, according to ONC.
    • “Together these findings demonstrate increased patient demand for and use of online health information by individuals in recent years,” the office wrote in the brief, citing data from the 6,252-respondent 2022 Health Information National Trends Survey.
    • “Patients who were offered access to their online medical records also used them more frequently—54% reported accessing their records at least three times during 2022, compared to 38% in 2020 and 26% in 2017.”
  • Healthcare IT News notes,
    • “The emergence of telehealth during the COVID-19 pandemic and the resulting surge in the adoption of telemedicine are helping address patients’ needs without major signs of safety concerns, according to a study by Kaiser Permanente.
    • “The study, published in the Annals of Internal Medicine, analyzed more than 1.5 million adult patients at Kaiser Permanente Northern California in 2021, and compared treatment and follow-up visits among primary care telemedicine (video and telephone) and in-person office visits.
    • “Of the 2,357,598 primary care visits analyzed, just over half (50.8%) utilized telemedicine, which broke down to just under 20% composed of video visits and 31.3% telephone visits.
    • “The findings indicate that medication prescriptions were lower for video and telephone visits at 38.4% and 34.6%, respectively, compared to in-person visits at 46.8%. Additionally, follow-up appointments within seven days were less frequent for in-person visits (1.3%) compared to video (6.2%) and telephone (7.6%) visits.”
  • Per Medscape,
    • “Among the 3188 people with type 2 diabetes who were adherent to their tirzepatide (Mounjaro, Lilly) regimen in four pivotal trials of the agent, a quarter achieved at least a 15% cut from their baseline body weight after 40–42 weeks of treatment, and researchers found seven baseline variables that were significantly linked with a higher incidence of this level of weight loss.
    • “These findings help inform which people with type 2 diabetes are most likely to achieve greater body weight reduction with improved cardiometabolic risk factors with tirzepatide,” say the authors.”
  • HR Dive offers advice to employers about how to extend a helping hand to employees in their first trimester of pregnancy.

From the U.S. healthcare business front,

  • Mercer Consulting offers plan design advice to self-fund health plan sponsors. For example,
    • “Commit to affordable plan designs. One of the biggest reasons people delay care is because they can’t afford to pay for care. Encourage use of preventive care and chronic condition management. 
    • “Provide advocacy support to help plan members get to the most appropriate care and setting. 
    • “Review the emerging spectrum of virtual care for options to help rein in costs while making care more accessible and affordable to plan members. 
    • “Now is the time to consider the long list of network options that exist in the market today and could result in cost savings.   
    • “If you haven’t explored reference-based pricing, you might want to do so. The protections offered by the No Surprises Act make this a more attractive and less risky option for plan members. 
    • “Make mental health a priority. People with medical conditions often have mental health needs. People with mental health needs often develop medical conditions. It is an investment you can’t afford to overlook. 
    • “Focus on pharmacy. Prescription drug costs are a top driver of medical plan cost increases mostly associated with new drugs and the cost of specialty drugs.” 
  • The Wall Street Journal reports,
    • Big Pharma is almost finished with the cough and cold medicine business.
    • French drug giant  Sanofi said Friday it plans to spin off its consumer-health business, which includes well-known brands like allergy medicine Allegra and the pain treatments IcyHot and Aspercreme.
    • — to hive off a division selling over-the-counter medicines and other retail products to focus on more commercially lucrative but scientifically riskier prescription drugs.
    • Once the split is completed as early as the fourth quarter of next year, there will be just one consumer-health business left under the umbrella of a big drugmaker parent. Germany’s Bayer will be the largest drugmaker with such a business. 
    • Sanofi and its rivals have made the moves in the hunt for higher margins and faster sales growth. “It allows Sanofi to become a pure-play biopharma company. We’ll be more agile and more focused in our areas of key areas of strength,” Chief Executive Paul Hudson said.
    • Yet the companies lose the crutch of a reliable source of cash flow and now face more pressure to hit on breakthrough medicines with large sales potential.

Midweek update

Photo by Manasvita S on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “The House elected GOP Rep. Mike Johnson of Louisiana as speaker Wednesday, with the staunch conservative overcoming the divisions that had paralyzed the chamber after a band of hard-liners ousted Kevin McCarthy three weeks ago.
    • “The choice of Johnson, aligned with former President Donald Trump, came after House Republicans nominated and then dumped a series of leadership candidates, prompting some members to wonder whether any colleague could thread the needle in the deeply divided conference. With a speaker now in place, lawmakers can return to work, with many eager to pass aid for Israel and address a looming government-funding deadline next month.”
  • STAT News tells us,
    • “A Senate health panel on Wednesday voted to send President Biden’s nominee to lead the National Institutes of Health to the chamber’s floor, moving Monica Bertagnolli one step closer to taking the longtime vacant role of permanent director.
    • “The Senate HELP Committee advanced her nomination on a 15-6 vote, with many Republicans voting in support and only Chairman Bernie Sanders (I-Vt.) breaking with the Democratic caucus to vote against her. * * *
    • “Her nomination will now move to the Senate floor for a full vote, though it is unclear when that will be scheduled.”
  • The NIH National Cancer Institute shares its weekly research highlights.
  • The American Hospital Association News points out,
    • “Starting Oct. 25, consumers can preview their 2024 health coverage options at the federally facilitated Health Insurance Marketplace. Open enrollment for the 2024 marketplace runs Nov. 1 through Jan. 15, with coverage starting Jan. 1 for consumers who enroll by midnight on Dec. 15. The Centers for Medicare & Medicaid Services expects that 96% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies.”
  • FedWeek calls attention to the fact that the U.S. Office of Personnel Management’s Inspector General has released its annual report identifying top management challenges.

From the Federal Employee Benefits Open Season front, FedSmith provides a healthcare roadmap for federal retirees. Govexec provides its perspective on Open Season planning here.

From the public health front,

  • Politico reports,
    • “So far, 12 million people, or about 3.6 percent of the population, have gotten the shot in the five weeks since it hit pharmacy shelves — though reporting lags mean it’s likely a bit higher, Centers for Disease Control and Prevention Director Mandy Cohen said.
    • “More people, by far — 16 million — have gotten their annual flu vaccine, Cohen said, attributing the difference to long-held routines.”
  • From Fierce BioTech,
    • “As Americans flock to nearby orchards for festive bouts of autumn apple picking, Insulet is celebrating a particularly bountiful stateside Apple harvest itself.
    • “The diabetes device maker has earned FDA clearance for the iPhone version of an app allowing users to control their Omnipod 5 insulin pumps from their own smartphones. Meanwhile, the app has been available to Android owners since the pump’s full U.S. launch began a year ago.
    • “In Insulet’s Monday announcement about the Apple clearance, Eric Benjamin, the company’s chief product and customer experience officer, hailed the impending launch of the app as a “significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes.”
  • Morning Consult informs us,
    • “28% of U.S. adults said they are interested in taking prescription GLP-1 drugs like Ozempic, Mounjaro or Wegovy for weight loss, a share relatively consistent with August and April surveys. 
    • “Consumers who have heard “a lot” about the drugs, have weight-related health conditions or have higher incomes are most likely to be interested in taking the medications.
    • “The impacts of weight loss drugs on the health industry are clear, but other sectors, like food and retail, are likely to feel the effects of changing consumer preferences. Brands that create products and services to help support a more health-conscious consumer will be best-positioned to weather disruption from Ozempic or future weight loss drug innovations.”
  • Per MedTech Dive,
    • “Boston Scientific shared pivotal trial results on Wednesday that showed promising results for its drug-eluting balloon in treating patients with repeat blockages.
    • “The company’s Agent drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries at one year, according to data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference. Boston Scientific was the study sponsor.”
  • BioPharma Dive lets us know,
    • “Patients with Alzheimer’s disease may have another treatment option in the not-too-distant future, as newly released data appear to support a more convenient version of the closely watched medicine Leqembi.
    • “Developed by partners Eisai and Biogen, Leqembi is the only Alzheimer’s medicine of its type with a full approval from the Food and Drug Administration. It’s specifically for patients in the early stages of the disease, and is given as an hourlong, intravenous infusion once every two weeks.
    • “Eisai and Biogen have been testing whether a different form of Leqembi, an under-the-skin injection, can be as safe and effective as the already marketed version. On Wednesday, at a medical conference in Boston, researchers presented results from a study of nearly 400 participants that suggests the two forms are roughly comparable.”
  • The New York Times reports,
    • “In the year after the Supreme Court ended the constitutional right to abortion, something unexpected happened: The total number of legal abortions in the United States did not fall. Instead, it appeared to increase slightly, by about 0.2 percent, according to the first full-year count of abortions provided nationwide.
    • “This finding came despite the fact that 14 states banned all abortions, and seven imposed new limits on them. Even as those restrictions reduced the legal abortion rate to near zero in some states, there were large increases in places where abortions remained legal. Researchers said they were driven by the expansion of telemedicine for mail-order abortion pills, increased options and assistance for women who traveled, and a surge of publicity about ways to get abortions.”

From the U.S. healthcare business front,

  • Beckers Hospital Review notes, “Newsweek has released the top 600 U.S. hospitals ranked by state, sorted by a score that factors recommendations, patient experience, quality and patient-reported outcome measures.” The article identifies the top hospital on the Newsweek scale in each State and DC.   
  • Beckers Payer Issues tells us how payer accountable care organizations (ACOs) fared in 2022.
  • Beckers Hospital Review also interviews an executive from a Texas hospital about how the facility is planning to emerge from Chapter 11 bankruptcy.
  • Per Fierce Healthcare,
    • “An otherwise strong Q3 performance across HCA Healthcare’s businesses was marred by news that the for-profit’s recently integrated physician staffing joint venture will be bleeding tens of millions of dollars per quarter for the foreseeable future.”
  • and
    • “UnitedHealth Group is making a $5 million investment in Enable Ventures, a fund that aims to improve the lives of people with disabilities.
    • “The investment will back companies that can create better quality of life, offer resources to entrepreneurs with disabilities and provide support to people with disabilities who are unemployed or underemployed. Enable puts a focus on providing the technologies and tools necessary to upskill or reskill people with disabilities to help them enter or reenter the workforce, according to the announcement.
    • “Catherine Anderson, senior vice president of health equity strategy at UnitedHealth Group, told Fierce Healthcare in an interview that backing Enable aligns with the company’s broader investment strategy around health equity.”

Monday Roundup

Photo by Sven Read on Unsplash

From Washington DC

  • The Wall Street Journal reports
    • “A bid by House Majority Whip Tom Emmer (R., Minn.) to serve as the House Republicans’ pick to be speaker will test whether the strong ties he built recruiting candidates and counting votes will overcome doubts from some anti-establishment lawmakers aligned with former President Donald Trump.
    • “Candidates are expected to pitch their colleagues at a forum on Monday evening ahead of an internal vote to designate a new Republican speaker nominee as soon as Tuesday morning. Beyond winning the GOP ballot, the speaker nominee will face the uphill battle to unite almost all Republicans to have a chance of winning the House vote, given Republicans’ narrow 221-212 majority.  * * *
    • “To become House speaker designate, the winning candidate must garner a majority of the votes cast within the Republican conference. The internal House GOP conference voting could go multiple rounds, with the candidate receiving the fewest number of votes dropping out after each round until a candidate wins 50% of the vote plus one. After that, the House speaker-designate must win support from a majority in the House, hitting 217 of the 433 House votes if all members show up and cast a vote for an individual.
    • “In an effort to prevent holdout candidates from delaying the process, GOP Rep. Mike Flood of Nebraska is circulating a unity pledge, which lawmakers can sign saying that they promise to back the party’s speaker designee in a House floor vote. His spokeswoman on Monday morning said that all of the candidates except [Rep. Gary] Palmer [R Alabama] have signed on.”
  • Govexec tells us
    • “Lawmakers from both parties last week revived legislation that would allow most federal employees who began their careers as temporary or seasonal workers to make catch-up contributions to their pensions so that they can retire on time.
    • “The Federal Retirement Fairness Act (H.R. 5995), introduced by Reps. Derek Kilmer, D-Wash., Gerry Connolly, D-Va., Don Bacon, R-Neb., and David Valadao, R-Calif., would allow employees enrolled in the Federal Employees Retirement System who began their careers in government as temporary workers to make catch-up contributions to their defined benefit pensions to cover for the time before they had permanent positions and were unable to contribute to their retirement accounts. The legislation was last introduced in 2021 but failed to garner support.”
  • Labor Department Assistant Secretary for Employee Benefits Security Lisa Gomez writes in her blog about Breast Cancer Awareness Month.
  • BioPharma Dive informs us,
    • “The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizer’s shot Penbraya in teenagers and young adults for protection against the five most common disease-causing serogroups.
    • “Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. While meningococcal disease is rare, it can be serious and even deadly.
  • EMPR adds that the “Food and Drug Administration (FDA) has approved Zituvio (sitagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
  • Per Medtech Dive,
    • Medtronic said Monday it received approval from the Food and Drug Administration for an extravascular defibrillator designed to treat abnormal heart rhythms and prevent sudden cardiac arrest, which can lead to death within minutes if not treated immediately.
    • Unlike traditional implantable cardioverter defibrillators, which have lead wires running between a pulse generator and the heart, Medtronic’s Aurora EV-ICD places a lead outside of the heart and veins.
    • The Aurora EV-ICD was a PMA submission to the FDA, Medtronic spokesperson Tracy McNulty said in an email. “We estimate the current global EV-ICD market to be between $300-$350 million, and expect the EV-ICD market to reach $1 billion 10 years out from the Aurora launch,” McNulty said.

From the public health / research front,

  • MedPage Today points out,
    • “Children infected with the Omicron variant of SARS-CoV-2 appear to be infectious for about 3 days after a positive test, researchers found.
    • “In a small study of 76 kids ages 7 to 18, the median duration of infectivity was 3 days for both vaccinated and unvaccinated children, Neeraj Sood, PhD, of the University of Southern California, and colleagues reported online in a JAMA Pediatrics research letter.
    • “The vast majority of children who get COVID are symptomatic for 1 to 3 days,” co-author Eran Bendavid, MD, MS, of Stanford University, told MedPage Today. “Basically that correlates with how long the virus is causing disease in their body.”
  • and
    • “Maternal mRNA COVID-19 vaccination during pregnancy was associated with lower risks of poor neonatal outcomes, including neonatal death, according to a population-based retrospective cohort study from Canada.”
  • Health Day notes,
    • “Gun homicide rates went down in 2022, following increases reported during the pandemic.
    • “But race still played an outsized role, with Black people continuing to have the highest firearm homicide rates, and by a wide margin.
    • “American Indian/Alaska Natives were the only groups to see an increase again in 2022.
  • The Wall Street Journal reports
    • “The age women start taking menopausal hormone therapy and the kind they take might affect their chances of developing dementia later in life, a new study found.
    • “Women have struggled for years with whether to take hormone therapy when they go through menopause. The medication can help relieve troubling symptoms such as hot flashes and night sweats. However, years of conflicting research on whether the therapy can lead to other health problems, including breast cancer, dementia and heart attacks, has left many women confused about what to do.
    • “This new study suggests that hormone therapy might lower—or at least not raise—your dementia risk if you take it in midlife. For older women, the study found some signs that the medication might raise it.
  • mHealth Intelligence explains that “The shift to telebehavioral healthcare during the COVID-19 pandemic is linked to fewer disruptions in psychotherapy services, indicating telehealth can be effective in supporting the continuity of these services, a new study shows.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Physicians’ decisions to leave their practices is a complex choice “with multiple interdependent factors,” and is not solely impacted by burnout, pay or frustrations with electronic health records, according to a new qualitative study published in ​​the Journal of the American Board of Family Medicine.
    • “The study, which interviewed physicians who left their ambulatory care practices between 2018 and 2021, found that they were motivated to increase time off, have more flexibility or receive higher earnings. However, other departing physicians reported higher compensation would not have persuaded them to stay.
    • “Physician practices can better retain clinicians by addressing risk factors for departure including workflow distribution across team members and ensuring adequate staffing, the report said.”
  • The Wall Street Journal reports,
    • Roche Holding has agreed to buy the developer of a bowel-disease treatment from Roivant Sciences, a company started by Republican presidential candidate Vivek Ramaswamy, and Pfizer in a deal worth more than $7 billion.
    • “The Swiss pharmaceutical giant said Monday it would pay $7.1 billion upfront for Telavant Holdings and make a near-term milestone payment of $150 million. Roche said the deal gives it rights to commercialize Telavant’s RVT-3101 drug candidate, which has shown promise for inflammatory bowel disease and could have potential in other indications in the U.S. and Japan. 
    • “The deal is the latest example of a big pharma company turning to the deal table to bolster its pipeline of autoimmune drugs. Merck earlier this year agreed to pay more than $10 billion to buy Prometheus Biosciences, which is developing a drug for inflammatory bowel disease that would compete with Telavant’s candidate.”
  • Per Fierce Healthcare
    • “Folx Health, a virtual provider focused on LGBTQ+ health, is now in-network with Cigna, Evernorth and Blue Shield of California.
    • “Other payer partners include Blue Cross and Blue Shield of Texas and Optum for behavioral health service in Colorado and Florida, according to Folx Health’s website. Through the collaboration, insured patients can use therapy and mental health medication management with Folx’s LGBTQ-specialized clinicians. 
    • “Folx offers virtual primary care, gender-affirming care and mental health services. Making that care in-network will deliver its patients significantly lower out-of-pocket costs, per the company.”
  • Assured Partners offers HSA and FSA Account Reminders for Year-End.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Washington, DC,

  • The Wall Street Journal reports,
    • Republican speaker nominee Rep. Jim Jordan was weighing whether to embark on a third-floor vote after a plan to temporarily put caretaker speaker Rep. Patrick McHenry in charge of the House ran into sharp objections from conservatives.
    • “I am still running for speaker, and I plan to go to the floor and get the votes and win this race,” Jordan said initially after leaving a heated closed-door meeting of House Republicans. The Ohio conservative said the plan to elect a temporary speaker didn’t have the support of the conference.
    • In the evening, Jordan met in a House office with detractors. As some trickled out, there was no sign he had managed to change their minds, and Jordan wouldn’t say after the meeting whether he still intended to hold another floor vote. 
  • The New York Times adds, “Mr. Jordan said he would push for another vote to become speaker, scheduled for Friday at 10 a.m., even though he was bleeding support and calls were increasing for him to step aside.”
  • The Society for Human Resource Management informs us,
    • “The U.S. Supreme Court has agreed to hear two cases that will impact the power of federal agencies to implement regulations on employers.
    • “On Oct. 13, the court decided to hear Relentless v. Department of Commerce, in which the owners of three fishing companies in Rhode Island and Massachusetts sued to challenge the federal government’s authority to require them to partially pay for federal monitors on their boats. The justices willconsider that case in tandem with a similar case, Loper Bright Enterprises v. Raimondo, which involves the same requirement for fishing companies in New Jersey.
    • “In both cases, the justices will decide whether to overturn the long-standing Chevron precedent, which holds that when Congress wrote a statute without a clear meaning, courts should defer to the federal agency applying the law, unless its directives were unreasonable. Federal departments and agencies that enforce employment laws could be impacted.”
  • In yesterday’s post, the FEHBlog called attention to AHIP’s public comments on the proposed rule, making changes to the current mental health parity rules. AHIP asked the regulators to try again. Per Fierce Healthcare,
    • “The Blue Cross Blue Shield Association (BCBSA) echoed AHIP in its comments, arguing that additional clarity around the changes is necessary. The organization said it could lead patients to care that is not recommended, worsening outcomes.
    • “We share the administration’s goal of expanding access to affordable mental health support, but we’re concerned it could become harder—not easier—for patients to get the care they need,” said David Merritt, BCBSA’s senior vice president of policy and advocacy, in a statement.
    • “This rule could push us in the wrong direction by forcing health plans to remove important protections that ensure patients are receiving safe, medically necessary, effective care,” Merritt added. “We’ll continue to work with our partners, the administration and Congress to improve both access and quality for Americans.”
    • “The Alliance for Community Health Plans said the updates create “an entirely new regulatory schema” that would actually impede insurers looking to address mental health parity.
    • “The ERISA Industry Committee, or ERIC, said many of the proposals “reflect an overreach of agency authority under the statute” and that they would be burdensome for employer-sponsored health plans. The changes, ERIC said, could drive up costs for families and force significant changes to benefit designs.
    • “Unfortunately, the proposed regulations are so unworkable, it is unclear how compliance could ever be achieved while continuing to offer these important benefits,” said James Gelfand, CEO of ERIC, in a statement. “The Departments’ proposals are written in a way that sets plans up to fail.”
  • The FEHBlog agrees.
  • Reuters tells us,
    • “The U.S. health regulator [the Food and Drug Administration] has approved Hyloris Pharmaceuticals’ drug for post-operative pain, the Belgium-based company said on Wednesday, adding that it expects to launch the non-opioid treatment in the United States by early next year.
    • “The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally.
    • “Maxigesic IV, a combination of paracetamol with ibuprofen solution for infusion, helps reduce pain and inflammation without the risk of opioid addiction that resulted in more than half a million deaths in the U.S. during 1999 to 2020.”

From the public health front,

  • HHS’s Agency for Healthcare Research and Quality posted for public comment an Effective Health Programs abstract on caring for Long Covid. The comment period ends on November 17, 2023.
  • Healio points out,
    • “Data show CMS’ Million Hearts CVD Risk Reduction Model, which provided payments for CVD risk assessment and reduction, reduced incidence of first-time MIs and strokes over 5 years without significant changes in Medicare spending.
    • “The results support clinical guidelines for CVD preventive care,” G. Greg Peterson, PhD, MPA, a principal researcher with Mathmatica, told Healio. “Current guidelines in the U.S., similar to those in other countries, recommend that health care practitioners calculate CVD risk scores and use the scores to engage patients in discussions about CVD prevention. Although previous studies of CVD risk scoring interventions have shown improvement in CVD risk factor control, this is the first study of a CVD risk score-focused intervention to demonstrate declines in CVD events.”
  • Health Day lets us know,
    • “Fluctuating blood pressure can be a harbinger for both dementia and heart disease, a new study finds.
    • “Ups and downs within 24 hours or even over several days or weeks were linked with impaired thinking, researchers from Australia reported.
    • “Higher variations in systolic blood pressure, the top number, were linked with stiffening of the arteries, which is associated with heart disease.
    • “Clinical treatments focus on hypertension while ignoring the variability of blood pressure,” said lead author Daria Gutteridge, a PhD candidate at the University of South Australia’s Cognitive Aging and Impairment Neuroscience Laboratory.”
  • The National Institutes of Health announced,
    • “A research team funded by the National Institutes of Health has developed a smartphone app that can track and analyze a person’s ability to move from one place to another, known as locomotion and other types of movements. Human motion analysis is used to evaluate patients with movement difficulties, to help clinicians plan surgery, and to assess the results of treatment procedures. The research team believes that using the app costs about 1% of conventional motion analysis techniques and works 25 times faster. The study appears in PLOS Computational Biology.
    • “Researchers tested their app, called OpenCap, with 100 participants. Using two or more smartphones, the app recorded sufficient quality videos to allow for web-based, artificial intelligence analysis of muscle activations, joint loads and joint movements. Data collection took 10 hours for the 100 participants, and computation of results took 31 hours. Traditionally, locomotion analysis requires fixed lab space and more than $150,000 worth of equipment, including eight or more specialized cameras to capture three-dimensional images. The captured data also takes several days to analyze by a trained expert.
    • “While current technology is too expensive for routine clinical use, according to the investigators, the app could potentially be used to help screen for disease risk, inform rehabilitation decisions, and track improvements in motion following treatment.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • CVS Health is pulling some of the most common decongestants from its shelves and will no longer sell them, after advisers to U.S. health regulators recently determined that an ingredient doesn’t work.
    • The products contain [as the only active ingredient] oral phenylephrine, an almost-century-old ingredient in versions of decongestants and over-the-counter pills, syrups and liquids to clear up congested noses.
    • An advisory panel to the Food and Drug Administration last month declared that the ingredient was ineffective when taken orally. The FDA had said in its own analysis that the oral phenylephrine formulations are safe but ineffective at standard or even higher doses.
    • The FDA hasn’t made a decision yet nor asked manufacturers or retailers to remove products from store shelves. CVS is removing phenylephrine products voluntarily.
  • Beckers Hospital Review informs us,
    • “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. “In a bankruptcy court filing Oct. 18, Rite Aid said it will close 154 stores in more than 10 states to save on rent costs, according to The New York Times. Details on the round of store closures came just days after the retail pharmacy chain filed for Chapter 11 bankruptcy protection. 
    • “Rite Aid has more than 2,000 stores in 17 states. Of the 154 planned closures, about 40 are Pennsylvania locations. Many stores in California and New York will also close, and additional store closings may be forthcoming as Rite Aid looks to shed about $4 billion in debt
    • “The Philadelphia-based company previously said it secured $3.45 billion from lenders to fund operations through the bankruptcy restructuring, with McKesson Corp. as the largest creditor. Alongside the bankruptcy filing, Rite Aid announced Jeffrey Stein as its new CEO and chief restructuring officer.”

Midweek Update

Photo by Manasvita S on Unsplash

From Washington DC,

  • The Wall Street Journal reports,
    • “GOP Rep. Jim Jordan failed again to win enough votes to be elected House speaker, as divisions hardened for House Republicans, with some lawmakers pursuing new paths to break the impasse that has paralyzed the chamber.
    • “More than two weeks after former House Speaker Kevin McCarthy (R., Calif.) was ousted, Republicans remained gripped in a fierce internal struggle over his successor. Jordan said he would keep up his campaign, but pushed off any further voting until Thursday at the earliest as mounting GOP defections on his second ballot left Republicans snarled into warring factions over what should happen next.”
  • The Federal Times informs us that the Senate is considering a bipartisan bill to improve benefits for the families of federal employees who die on the job.
  • Govexec tells us,
    • “A bipartisan trio of Senators hope to advance new legislation aimed at improving and “streamlining” federal agencies’ customer service across platforms, in part by adopting practices already employed in the private sector.
    • “Customer service at agencies that interact with members of the public has been top of mind for lawmakers and administration officials in recent years. During the height of the COVID-19 pandemic, that attention was on electronic means like phone and the Internet, while over the last 18 months, the focus turned toward in-person service as well as backlogs that cropped up over the course of the pandemic.
    • “The Improving Government Services Act (S. 2866), introduced by Sens. Gary Peters, D-Mich., James Lankford, R-Okla., and John Cornyn, R-Texas, last month but publicized Tuesday, tasks federal agencies that provide services to members of the public to develop annual customer experience action plans and submit them both to the director of the Office of Management and Budget and Congress. The Senate Homeland Security and Governmental Affairs Committee is slated to consider the bill next week.”
  • MedPage Today discusses today’s confirmation hearing for the President’s nominee to be NIH Director, Dr. Monica Bertagnolli.
    • “In laying out her vision for the agency, a key theme for Bertagnolli was equity. “NIH can and must support research that is equitable and accessible to all populations,” she said, stressing the need to diversify clinical trials.”
  • The Internal Revenue Service announced, “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2023, and before October 1, 2024, is $3.22. This is the per belly button fee that FEHB plans will owe for the current 2023 plan year next July 31, 2024.
  • HHS Office for Civil Rights issued “Resources for Health Care Providers and Patients to Help Educate Patients about Telehealth and the Privacy and Security of Protected Health Information.”
  • AHIP posted its helpful comments on the proposed mental health parity rule changes. The public comment deadline was yesterday.
  • Fedsmith offers its guidance on the upcoming Federal Employee Benefits Open Season.

From the public health front,

  • STAT News reports,
    • Treatments like Ozempic, Wegovy, and Mounjaro have been hailed for showing 15% to over 20% weight loss in trials, but those are just averages. In reality, there are big variations in how much weight people lose on the therapies, and it’s unclear what explains those differences.
    • “One way researchers are trying to figure this out is by focusing on genes.
    • “The variability is so wide that we want to understand what predicts response,” said Lee Kaplan, chief of obesity medicine at the Geisel School of Medicine at Dartmouth. Since genetics is a significant reason people develop obesity, and since early data also show that genetics may contribute to how people respond to bariatric surgery, “that would argue that there’s probably going to be a genetic contribution” to the amount of weight loss people experience on obesity drugs.”
  • Beckers Hospital Review discusses what the closure of various Walgreen’s and Rite Aid drug stores means for healthcare.
    • “The closures also disproportionately affect Black and Latino city neighborhoods, as well as rural areas, according to Serena Guo, MD, PhD, an assistant professor at the Gainesville-based University of Florida College of Pharmacy. 
    • “Closure has the potential to worsen disparities in access to pharmacies,” Dr. Guo told MarketWatch.”
  • The National Institutes of Health announced,
    • “Starting buprenorphine treatment for opioid use disorder through telehealth was associated with an increased likelihood of staying in treatment longer compared to starting treatment in a non-telehealth setting, according to a new study analyzing Medicaid data from 2019-2020 in Kentucky and Ohio. Published in JAMA Network Openthese findings(link is external) add to a growing body of evidence demonstrating positive outcomes associated with the use of telemedicine for treatment of opioid use disorder.
    • “In Kentucky, 48% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 44% of those who started treatment in non-telehealth settings. In Ohio, 32% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 28% of those who started treatment in non-telehealth settings.”
  • HealthDay points out,
    • “Researchers have identified a link between attention-deficit/hyperactivity disorder (ADHD) in adults and dementia.
    • “The risk of dementia is three times higher in adults with ADHD, according to a large study of Israelis who were followed for 17 years.
    • “More research is needed to verify the findings and understand the link.”
  • The Wall Street Journal reports,
    • Pfizer will price a course of its Covid-19 drug Paxlovid at nearly $1,400 when commercial sales begin later this year, more than double what the U.S. government has paid.
    • “Pfizer told the pharmacies and clinics that will dispense Paxlovid, in a letter dated Wednesday that was viewed by The Wall Street Journal, that a five-day course of the antiviral will list for $1,390. The U.S. government had paid $529.
    • “Health plans will probably pay much less than the list price for the pills, and most patients will have a small or no out-of-pocket cost because Pfizer is expected to offer price discounts and help patients with their out-of-pocket charges.
    • “Pfizer has already faced criticism from doctors and patient advocates that raising the price will limit patient access. Disclosure of the list price will probably fuel further criticism.”

From the U.S. healthcare business front,

  • KFF reports,
    • “Amid rising inflation, annual family premiums for employer-sponsored health insurance climbed 7% on average this year to reach $23,968, a sharp departure from virtually no growth in premiums last year, the 2023 benchmark KFF Employer Health Benefits Survey finds.
    • “On average, workers this year contribute $6,575 annually toward the cost of family premium, up nearly $500 from 2022, with employers paying the rest. Future increases may be on the horizon, as nearly a quarter (23%) of employers say they will increase workers’ contributions in the next two years.
    • “Workers at firms with fewer than 200 workers on average contribute nearly $2,500 more toward family premiums than those at larger firms ($8,334 vs. $5,889). In fact, a quarter of covered workers at small firms pay at least $12,000 annually in premiums for family coverage.
    • “This year’s 7% increase in average premiums is similar to the year-over-year rise in workers’ wages (5.2%) and inflation (5.8%). Over the past five years, premiums rose 22%, in line with wages (27%) and inflation (21%).”
  • Per WXYZ.com (Detroit MI),
    • “Henry Ford Health and Ascension Michigan have signed an agreement to enter into a joint venture, the latest merger between health systems in Michigan.
    • “According to the health systems, Ascensions Southeast Michigan and Genesys healthcare facilities will join with Henry Ford’s. * * *
    • According to the companies, the combined organization would employ around 50,000 team members at more than 550 sites of care across the area.”
  • Healthcare Dive adds,
    • “Thirty-nine percent of mergers and acquisitions announced in the third quarter included a hospital or health system that cited financial distress as a driver for deal, according to a report by Kaufman Hall. 
    • “Though M&A activity is continuing to trend back to pre-pandemic levels, the number of hospitals in distress shows the financial strain of the past two years, the report said. Eighteen transactions were announced in the third quarter, compared with just seven in the same period in 2021 and 10 during the third quarter in 2022.
    • “Increased costs, both for labor and other expenses, has been a significant challenge for smaller and medium-sized health systems. Now, more large systems — with annual revenue of $1 billion or more — are pointing to financial concerns as their reason for dealmaking, according to Kaufman.”
  • Beckers Payer Issues notes,
    • “In the third quarter, we completed a strategic review of our operations, assets, and investments to enhance operating efficiency, refine the focus of our investments in innovation and optimize our physical footprint,” the company wrote. “This resulted in a net charge of $697 million, comprised of the write-off of certain information technology assets and contract exit costs, a reduction in staff including the relocation of certain job functions, and the impairment of assets associated with the closure or partial closure of data centers and offices.”
    • “Elevance Health posted $1.3 billion in net income during the third quarter, a nearly 20% decrease compared to the same period last year, according to the company’s earnings report published Oct. 18.
  • and
    • “Consumers’ overall satisfaction with health insurers is up 4% over 2023, according to a report from the American Customer Satisfaction Index published Oct. 17. 
    • “Customer satisfaction with insurers reached a score of 76 out of 100, the highest in the index’s history, according to the report.” 
  • Per Fierce Healthcare,
    • “Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday.
    • “The pharmacy deliveries will be dropped, quite literally, outside a consumer’s front door within 60 minutes at no additional cost for eligible Amazon Pharmacy customers, the company said.
    • “Amazon Pharmacy is teaming up with the online retailer’s drone service, Prime Air, which kicked off commercial deliveries in the same Texas city in December.
    • “Delivery of medications via drone will be offered in College Station initially and will expand to additional cities in the coming years, an Amazon Pharmacy spokesperson said. The announcement was made this week as part of Amazon’s Delivering the Future event in Seattle focused on its latest innovations.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Rep. Jim Jordan (R., Ohio) failed to win enough votes Tuesday to be elected House speaker after more Republicans than expected joined Democrats in declining to back him, setting up lawmakers for an unpredictable second round of balloting.
    • “The favorite of the Republican base and ally of former President Donald Trump saw 20 GOP lawmakers break with him in the first round Tuesday afternoon, many more than the handful the GOP nominee could afford to lose. Democrats backed their pick, Minority Leader Hakeem Jeffries (D., N.Y.), while the Republican holdouts scattered their votes among other GOP figures.
    • “The result deflated hopes for a quick resolution of intraparty fighting * * *.
    • “After the failed vote, Republicans huddled in small groups to discuss their options. One approach would be to give more power to Speaker Pro Tempore Patrick McHenry (R., N.C.), if enough Republicans and Democrats supported the idea.”
  • The Federal Times shares the dates and deadlines to remember for FEHB open enrollment.

From the public health and research front,

  • Beckers Hospital Review informs us,
    • New weekly COVID-19 admissions are down for the fourth week straight, according to the latest data from the CDC. Meanwhile, flu and respiratory syncytial virus are starting to rise. 
    • COVID-19: COVID-19 metrics declined in the U.S. for the week ending Oct. 7. A total of 16,766 new COVID-19 admissions were reported this week, marking an 8.2% decline from the week prior. Emergency department visits related to the disease were also down nearly 18%. The decline in activity comes after about three months of steady increases in hospitalizations. Based on past trends, however, experts predict the nation may see another winter uptick in December or January — the same time of the year flu tends to peak. 
    • RSV: Cases of RSV have been slowly rising in the U.S. Overall, the positivity rate remains much lower than this time last year, though some hospitals in the South have started to see RSV hospitalizations increase. Holtz Children’s Hospital in Miami has seen a “five-fold increase for influenza and a two-fold increase for RSV,” the hospital’s chief medical officer, Barry Gelman, MD, told a local news outlet in a report earlier this month. 
    • Flu: Flu activity remains low nationally, with a positivity rate of 1.1% for the week ending Oct. 7. CDC officials told NBC News activity will likely ramp up over the next few weeks. Just over 1,100 patients with lab-confirmed flu were admitted to the hospital for the week ending Oct. 7, up slightly from the week prior. Most cases reported so far this season are influenza A.
    • Hospitalizations for flu, COVID-19 and RSV are projected to peak at the end of January. With that timeline, hospitals may see similar levels of capacity and resource strain as last respiratory virus season since peaks may overlap. Health experts have been optimistic that a collection of vaccines and a new monoclonal antibody for RSV would largely prevent severe illness and minimize capacity strain on hospitals. However, significant hurdles in accessing the shots may prevent them from reaching those most at risk of severe illness before virus season is in full swing. 
  • CIDRAP from the University of Minnesota tells us,
    • “A meta-analysis today in Antimicrobial Stewardship & Healthcare Epidemiology estimates a vaccine effectiveness (VE) of 69% for three doses of COVID-19 vaccine against long COVID, while two doses offer 37% efficacy.
    • “Led by researchers at the University of Iowa, the meta-analysis involved 24 studies on COVID-19 VE against long COVID among recipients of at least two doses of a vaccine before or after infection from December 2019 to June 2023.
    • “With the ongoing COVID-19 pandemic, a considerable proportion of individuals who have recovered from COVID-19 infection have long-term symptoms involving multiple organs and systems,” the researchers wrote.”
  • Healio points out,
    • “Adhering to a healthy lifestyle could reduce coronary health disease risk [by 25%] regardless of genetic susceptibility to abdominal obesity.
    • “The more favorable lifestyle included factors like a healthy diet and sleep habits.”
  • The NIH Directors Blog lets us know,
    • “Each year in the U.S., more than 500,000 people receive treatment for burn injuries and other serious skin wounds. To close the most severe wounds with less scarring, doctors often must surgically remove skin from one part of a person’s body and use it to patch the injured site. However, this is an intensive process, and some burn patients with extensive skin loss do not have sufficient skin available for grafting. Scientists have been exploring ways to repair these serious skin wounds without skin graft surgery.
    • “An NIH-funded team recently showed that bioprinted skin substitutes may serve as a promising alternative to traditional skin grafts in preclinical studies reported in Science Translational Medicine. The approach involves a portable skin bioprinter system that deposits multiple layers of skin directly into a wound. The recent findings add to evidence that bioprinting technology can successfully regenerate human-like skin to allow healing. While this approach has yet to be tested in people, it confirms that such technologies already can produce skin constructs with the complex structures and multiple cell types present in healthy human skin.”
  • The Washington Post discusses improving the availability of primary care in our country.
  • STAT News interviews the scientist who made Novo Nordisk an obesity drug powerhouse, Dr. Lotte Bjerre Knudsen.
    • “When the company invented a once-weekly version of the drug, called semaglutide, she spearheaded research to understand its biological impact on metabolism, cardiovascular and kidney health, and the brain. In clinical trials, semaglutide cut a person’s food intake by up to 35%, more than double the effect of liraglutide.
    • “Knudsen’s team conducted studies suggesting it achieves such dramatic results by modifying overlapping neural pathways involved in food intake, reward drives, and energy expenditure — studies that have helped prove that one molecule can, in fact, have multiple biologies. What the brain does with GLP-1 and what the gut does are two very different things. Drugs like liraglutide and semaglutide just happen to harness them both, separately, at the same time.
    • “Those lessons have led Knudsen to ask if GLP-1 might have other roles in the brain that could be exploited to therapeutic ends. One of the most promising areas she’s now focusing on is Alzheimer’s disease. Other researchers have their sights set on seeing if these drugs might help people with addiction and alcohol use disorders control their cravings.
    • “The science here is still early, Knudsen emphasized. But the fact that it exists at all owes much to her singular determination. “I’m actually quite patient,” she said. “When it comes to slowly working to progress something that could be important in the future, that needs to take its time.”

From the U.S. healthcare business front,

  • STAT News notes,
    • “Here at ObesityWeek, one of the largest conferences on obesity, Novo Nordisk and Eli Lilly are displaying more than a dozen studies that together carry the message: Our blockbuster weight loss treatments will be worth it for society.
    • “But experts point out that much of this company-funded research does not include the cost of the drugs themselves, which sell at more than $10,000 per year in the U.S. and are meant to be taken indefinitely. * * *
    • “As more economic analyses emerge, these questions of how worth it the new obesity drugs are will continue to be top of mind for clinicians, said Jamy Ard, president-elect of The Obesity Society and co-director of the Atrium Health Wake Forest Baptist Weight Management Center.
    • “We are stewards of the resources,” said Ard, who has consulted for Novo and Lilly. “If we are skeptical about the cost-effectiveness of the treatment, where we know that our patient populations can’t afford a certain therapy, then we’re not going to prescribe it. We’re not going to encourage health plans to approve the treatment or make treatment available to people if we think that there are better ways to spend those health care dollars.”
    • In the FEHBlog’s view, the manufacturers are not taking into account the rapidly growing number of people who may receive a prescription for these drugs.
  • Per Healthcare Dive,
    • “One Medical has quietly rebranded the senior care clinics it acquired from its 2021 buy of Iora Health to “One Medical Seniors” in an effort to better synchronize the two businesses.
    • “The rebrand, and ongoing efforts to expand the ability of One Medical clinics to treat a wider variety of patient populations, are likely to help the primary care provider nab more clients, analysts said.
    • “People need to know who they’re doing business with or receiving care from. And that’s especially true when you look at the senior population,” said Arielle Trzcinski, a principal analyst at Forrester who focuses on the digital and retail health markets. “So being able to apply the One Medical brand to Iora — it’s a trusted brand. So there’s an opportunity for net new customers.”
  • MedCity News observes,
    • “Rite Aid filed for Chapter 11 bankruptcy protection on Sunday amid decreasing sales, billions of dollars in debt and more than a thousand lawsuits claiming the chain filled illegal prescriptions for opioids. In order for the company to get back on its feet, experts say it will have to start acting more like its competitors, such as Walgreens and CVS, by leaning more into care delivery, forging strong payer partnerships, and improving its digital offerings.”

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House Republicans’ speaker nominee Rep. Jim Jordan (R., Ohio) won over some pivotal holdouts Monday as broader GOP opposition to his bid appeared to crumble, moving him closer to winning the gavel in a floor vote as soon as Tuesday afternoon.
    • “I feel real good about the momentum we have. It’s real close,” Jordan told reporters, citing recent endorsements and saying he was ready to move forward on Tuesday at noon. “We’re going to elect a speaker tomorrow; that’s what I think is going to happen.”
  • The U.S. Office of Personnel Management announced,
    • “[T]he Biden Administration has exceeded its goal of selecting 5,800 targeted positions helping implement the Bipartisan Infrastructure Law (BIL), a once-in-a-generation investment in America’s infrastructure and competitiveness. Over the last two years, OPM has served as a strategic workforce partner for seven federal agencies and supported surge hiring for key positions, including engineers, scientists, project managers, IT & HR specialists, construction managers, and many more. 
    • “The agencies included in targeted hiring positions are the Department of Agriculture, Department of Commerce, Department of Energy, Department of Homeland Security, Department of the Interior, Department of Transportation, and the Environmental Protection Agency.”
  • Govexec introduces us to the Partnership for Public Service’s Service to America Medal winners. Mazaal tov to the winners.
  • Thompson Reuters points out that last week, the Internal Revenue Service “released the final versions of the following 2023 Affordable Care Act (ACA) forms:
    • “(1) Form 1094-BTransmittal of Health Coverage Information Returns;
    • “(2) Form 1094-CTransmittal of Employer-Provided Health Insurance Offer and Coverage Information Returns;
    • “(3) Form 1095-BHealth Coverage; and
    • “(4) Form 1095-CEmployer-Provided Health Insurance Offer and Coverage.
    • The forms do not contain substantive changes.”

From the public health front,

  • The New York Times reports,
    • “A team of scientists is proposing a new explanation for some cases of long Covid, based on their findings that serotonin levels were lower in people with the complex condition.
    • “In their study, published on Monday in the journal Cell, researchers at the University of Pennsylvania suggest that serotonin reduction is triggered by remnants of the virus lingering in the gut. Depleted serotonin could especially explain memory problems and some neurological and cognitive symptoms of long Covid, they say.
    • “This is one of several new studies documenting distinct biological changes in the bodies of people with long Covid — offering important discoveries for a condition that takes many forms and often does not register on standard diagnostic tools like X-rays.
    • “The research could point the way toward possible treatments, including medications that boost serotonin. And the authors said the biological pathway that their research outlines could unite many of the major theories of what causes long Covid: lingering remnants of the virus, inflammation, increased blood clotting and dysfunction of the autonomic nervous system.
    • “All these different hypotheses might be connected through the serotonin pathway,” said Christoph Thaiss, a lead author of the study and an assistant professor of microbiology at the Perelman School of Medicine at the University of Pennsylvania.
    • “Second of all, even if not everybody experiences difficulties in the serotonin pathway, at least a subset might respond to therapies that activate this pathway,” he said.”
  • Last Friday, the Department of Health and Human Services announced,
    • “[T]he selection of initial next-generation vaccine candidates and more than $500 million in awards for Project NextGen – kick-starting planning for Phase 2b clinical trials and technologies that advance innovative next-generation vaccine and therapeutics platforms.
    • “The Biden-Harris Administration is committed to keeping people safe from COVID-19,” said HHS Secretary Xavier Becerra. “By investing in next-generation vaccines and treatments, we can improve our ability to respond to new variants, reduce transmission, stop infections, and save lives. Through Project NextGen, we are combining research and development expertise at HHS with the lessons learned throughout the pandemic to protect our nation from COVID-19.” 
    • “The over $500 million announced today builds on the over $1.4 billion awarded in August – accelerating products toward clinical trials and potential commercial availability.”
    • “The vaccine selections and funding announced today are important steps forward for Project NextGen – with vaccine and therapeutics candidates moving quickly to clinical trials that will start in the coming months,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “The technologies that BARDA is investing in, from intranasal vaccines to self-amplifying mRNA, will bolster our protection against COVID-19 for years to come.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us that UnitedHealth Group executives and the FEHBlog are of one mind.
    • “UnitedHealth Group wants to lower the price of GLP-1 drugs such as Ozempic and Wegovy, but it needs drug manufacturers to get on board, executives said. 
    • “On an Oct. 13 call with investors, UnitedHealth Group CEO Andrew Witty said prices have to come down for more people to access the drugs. 
    • “We’re very positive about the potential for another tool in the toolbox to help folks manage their weight,” Mr. Witty said. “We recognize that has potential benefits, but we’re struggling, and frankly our clients are struggling, with the list prices which have been demanded of these products in the U.S., which are running at about 10 times the level of prices paid in Western Europe.” 
  • Per Biopharma Dive,
    • “Novo Nordisk said Monday it will spend up to $1.3 billion to buy an experimental hypertension drug from Singapore-based KBP Biosciences, adding to a string of acquisitions that builds out its metabolic disease business behind the blockbuster diabetes drug Ozempic.
    • “The pill, called ocedurenone, is in a Phase 3 trial in people with chronic kidney disease and uncontrolled high blood pressure. Results are due next year, and Novo said it plans to begin additional Phase 3 trials in other cardiovascular and kidney disease indications.
    • “Novo is putting its profits from accelerating Ozempic sales to work, having cut late-summer deals to buy a Danish metabolic startup called Embark Biotech and a Canadian metabolic company called Iversago. That followed on the billion-dollar-plus deals to buy rare disease drug developer Forma Therapeutics in 2022 and genetic medicine company Dicerna in 2021.”
  • Fierce Healthcare tells us why Amazon’s chief medical officer believes Amazon can make a big impact in tackling chronic illness.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC,

  • The House Republicans have not settled on a new Speaker yet. Roll Call adds, “The delay in the effort to get 217 Republicans to back anyone for speaker is leading some House members to start reconsidering the idea that Speaker Pro Tempore Patrick T. McHenry is little more than a placeholder.”
  • This morning, the Social Security Administration announced
    • “Social Security and Supplemental Security Income (SSI) benefits for more than 71 million Americans will increase 3.2 percent in 2024. * * *
    • “The maximum amount of earnings subject to the Social Security tax (taxable maximum) will increase to $168,600.”
  • Federal News Network explains how the Social Security announcement impacts federal annuitant cost of living adjustments for 2024.
  • This afternoon, the Centers for Medicare and Medicaid Services announced Medicare Part B premiums for 2024 and more, e.g., income-adjusted premiums for Parts B and D.
    • “The standard monthly premium for Medicare Part B enrollees will be $174.70 for 2024, an increase of $9.80 from $164.90 in 2023. The annual deductible for all Medicare Part B beneficiaries will be $240 in 2024, an increase of $14 from the annual deductible of $226 in 2023. 
    • “The increase in the 2024 Part B standard premium and deductible is mainly due to projected increases in health care spending and, to a lesser degree, the remedy for the 340B-acquired drug payment policy for the 2018-2022 period under the Hospital Outpatient Prospective Payment System.
    • “Beginning in 2023, individuals whose full Medicare coverage ended 36 months after a kidney transplant and who do not have certain other types of insurance coverage can elect to continue Part B coverage of immunosuppressive drugs by paying a premium. For 2024, the standard immunosuppressive drug premium is $103.00.”
  • FedSmith shares Medicare basics for federal employees and annuitants.
  • Fierce Healthcare reports on a discussion of Medicare Advantage at the HLTH conference held in Las Vegas this week.

From the public health and research front,

  • The U.S. Preventive Services Task Force published a draft research plan on prostate cancer screening. The draft plan is open for public comment through November 8, 2023.
  • STAT News informs us,
    • “The brain remains both the body’s most important organ and its least understood. But a draft atlas of the human brain published on Thursday gives scientists important insights into how it works and may pave the way for big advances in disease treatment and diagnosis.
    • This brain map, pieced together by hundreds of researchers from San Diego to Seattle to Stockholm, is essentially a cellular “parts list” of the human brain and a guide to how those pieces are arranged and work together. Scientists say that what they’ve already learned — including a stunning diversity of cell types in the brain — and what they’ll discover in the years to come will improve our understanding of deadly neurological diseases. * * *
    • “The recent findings, reported across 21 studies published in the journals Science, Science Advances, and Science Translational Medicine, offer some early clues. And there’s more to come. These papers are part of an ongoing undertaking researchers openly compare to the Human Genome Project in both its scope and ambition. That project sequenced the DNA of a dozen blood donors from Buffalo, N.Y. The new brain atlas was constructed from the brains of more than 100 people, including deceased donors and surgical patients.”
  • The Wall Street Journal seeks to explain the secret of living to 100 years old.
    • “If you want to live to your 100th birthday, healthy habits can only get you so far.”If you want to live to your 100th birthday, healthy habits can only get you so far.
    • “Research is making clearer the role that genes play in living to very old age. Habits like getting enough sleepexercising and eating a healthy diet can help you stave off disease and live longer, yet when it comes to living beyond 90, genetics start to play a trump card, say researchers who study aging.
    • “Some people have this idea: ‘If I do everything right, diet and exercise, I can live to be 150.’ And that’s really not correct,” says Robert Young, who directs a team of researchers at the nonprofit scientific organization Gerontology Research Group. 
    • “About 25% of your ability to live to 90 is determined by genetics, says Dr. Thomas Perls, a professor of medicine at Boston University who leads the New England Centenarian Study, which has followed centenarians and their family members since 1995. By age 100, it’s roughly 50% genetic, he estimates, and by around 106, it’s 75%.” 
  • Beckers Clinical Research points out
    • “Researchers at Boston-based Harvard Medical School and University of Oxford in England have created an AI tool to forecast which COVID-19 strains will grow in dominance, according to an Oct. 11 article in Nature
    • “The tool, called EVEscape, predicts how the virus can evolve through a model of evolutionary sequences alongside biological and structural data, according to an Oct. 11 Harvard news release. EVEscape works to forecast which future COVID-19 strains are most likely to occur. 
    • “Every two weeks, the researchers will release a ranking of COVID-19 variants. 
    • “The rankings are available here.

From the U.S. healthcare business front,

  • Reuters tells us,
    • Shares of dialysis service providers fell sharply on Wednesday after Novo Nordisk’s Ozempic showed early signs of success in delaying the progression of kidney disease in diabetes patients.
    • Colorado-based DaVita’s shares closed down about 17% and U.S.-listed shares of German rival Fresenius Medical ended 17.6% lower.
    • Novo’s announcement is the latest sign of disruption caused by the success of GLP-1 drugs, which have hit shares of food companies, providers of bariatric surgery and glucose-monitoring device makers.
    • FEHBlog note: That is wiggly whack.
  • Healthcare Dive informs us
    • “Walgreens announced a 2024 earnings outlook below Wall Street expectations on Thursday, two days after announcing a new chief executive officer who the beleaguered retailer says will help with its strategic pivot to healthcare services.
    • “Along with the release of its fourth-quarter earnings, Walgreens said it expects adjusted earnings per share for its 2024 fiscal year to be between $3.20 to $3.50, below the analyst consensus of $3.71, due to lower profit from COVID-19 testing and vaccines among other factors.
    • “On a call with investors Thursday morning, Walgreens leadership said the Deerfield, Illinois-based retailer is focused on accelerating the profitability of its U.S. Healthcare division, which includes value-based medical group VillageMD. As part of that, Walgreens plans to close 60 underperforming VillageMD clinics next year.”
  • Per Beckers Hospital Review,
    • “Nearly two years after Mark Cuban launched a mail-order pharmacy with low-cost medications, the entrepreneur and “Shark Tank” star has secured more than a dozen collaborators. 
    • “In September, Mark Cuban Cost Plus Drug Co. penned a deal with Avanlee Care, which runs an app designed to help caregivers for elderly patients. The app, called Ava, will feature an option for its users to order medications from Cost Plus Drugs. Mr. Cuban’s company also teamed up with two fertility health companies to reduce the burden of the pink tax, or inflated prices on women’s products.
    • “Cost Plus Drugs has also expanded its in-person services by signing deals with pharmacies spanning multiple states and grocery chain pharmacies, such as Kroger. The affiliate network aligns Cost Plus Drugs’ pricing with medications at independent pharmacies. 
    • “In an insurance industry shake-up, Blue Shield of California chose Cost Plus Drugs and a few other vendors to take over services historically filled by CVS Caremark, CVS Health’s pharmacy benefit manager. Mark Cuban’s company is now a preferred pharmacy network for the insurer serving 4.8 million members.”  
  • and
    • “St. Louis-based Ascension is focused on rebounding from a $3 billion operating loss (-5.6 percent operating margin) in fiscal year 2023 amid negative outlooks from two ratings agencies. 
    • “Fitch Ratings recently lowered Ascension’s outlook from stable to negative while S&P Global Ratings affirmed its negative outlook for the health system. 
    • “Despite “real progress” to resume a more typical level of operations through significant and durable cost savings initiatives, Ascension saw a new set of operational challenges in FY 2023, Fitch said in a Sept. 26 report. The system hit its 2022 operational goals largely through improved efficiencies and contract labor and productivity initiatives, but additional challenges continued to hinder operations in FY 2023.
    • “One caveat on the $3 billion operating loss is that it included a one-time, non-cash impairment loss of $1.5 billion as the carrying value of certain assets within Ascension’s markets may not be fully recoverable, according to the health system. When normalized to exclude one-time items, Ascension’s operating loss for FY 2023 was $1.39 billion (-4.9 percent margin) compared to a $1.17 billion loss (-4.2 percent margin) in FY 2022.” 

Weekend update

From Washington, DC,

  • The Senate is on State work break this week, while the House of Representatives is focusing on electing a new Speaker on Wednesday October 11.
  • The Motley Fool tells us,
    • “The most important day of the year for the more than 66 million people who receive a Social Security benefit each month is nearly here. This coming Thursday, Oct. 12, 2023, at 08:30, a.m., ET, the Social Security Administration (SSA) will announce the 2024 cost-of-living adjustment (COLA). * * *
    • “Suffice it to say, the 2024 Social Security COLA isn’t going to be anywhere close to [2023’s historic] 8.7%. It will, however, be an above-average boost to benefits.
    • “According to the latest estimate from Mary Johnson, senior Social Security policy analyst at The Senior Citizens League (TSCL), a nonpartisan senior advocacy group focused on advancing issues important to seniors, the program’s COLA is expected to hit 3.2% for 2024. Over the past 20 years, Social Security’s COLA has averaged just 2.6%.”  

From the public health front,

  • The Washington Post informs us,
    • “In a sobering analysis, researchers warn that those who’ve had childhood cancer are highly likely to face physical and mental health challenges later in life, with 95 percent developing a “significant health problem” related to their cancer or treatment by age 45.”In a sobering analysis, researchers warn that those who’ve had childhood cancer are highly likely to face physical and mental health challenges later in life, with 95 percent developing a “significant health problem” related to their cancer or treatment by age 45.
    • “The researchers reviewed 73 studies, including 39 cohort studies that followed patients over time. Publishing their findings in JAMA, they said approximately 15,000 children and adolescents through age 19 are diagnosed with cancer every year and that 85 percent of children now live five years or more beyond their diagnosis. That’s compared with just 58 percent in the 1970s, according to the American Cancer Society.
    • “The research documented a variety of concerns for young cancer survivors, ranging from subsequent hormone issues to reproductive health challenges, problems with muscles and bones, cognitive impairment and more.”
  • The New York Times lets us know,
    • “A new study has an encouraging message for Americans who shy away from Covid shots because of worries about side effects: The chills, fatigue, headache and malaise that can follow vaccination may be signs of a vigorous immune response.
    • “People who had those side effects after the second dose of a Covid vaccine had more antibodies against the coronavirus at one month and six months after the shot, compared with those who did not have symptoms, according to the new study. Increases in skin temperature and heart rate also signaled higher antibody levels”
  • MedPage Today explains why utilizing artificial intelligence may reduce maternal and infant mortality.
    • “For example, “One of the biggest threats to maternal and infant health is the unmet needs within the social determinants of health, which often directly influence mothers’ ability to access healthcare services. If a pregnant woman doesn’t have access to reliable transportation to get her to and from the doctor or lives a significant distance from one, AI can measure how that might impact health outcomes for her and her unborn child. Then, it can flag it for her doctor or health plan so they can help solve these issues before they cause larger problems.
    • “The result? Reduced racial disparities for maternal health, fewer preterm births and neonatal intensive care unit (NICU) admissions, and shorter NICU stays.” 
  • Medscape reports,
    • “Once weekly glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide (Ozempic, Novo Nordisk) significantly improved A1clevel and body weight for up to 3 years in a large cohort of adults with type 2 diabetes, show real-world data from Israel.
    • “Treatment with semaglutide was associated with reductions in both A1c (-0.77%; P < .001) and body weight (-4.7 kg; P < .001) at 6 months of treatment. These reductions were maintained for up to 3 years and, in particular, in those patients with higher adherence to the therapy.
    • “Avraham Karasik, MD, from the Institute of Research and Innovation at Maccabi Health Services, Tel Aviv, Israel, led the study and presented the work as a poster at this year’s annual meeting of the European Association for the Study of Diabetes (EASD).”

From the U.S. healthcare business front

  • Forbes reports
    • “Uber Health is partnering with UnitedHealth Group’s Optum health services business to make paying for ancillary benefits like ride share and product delivery easier for seniors via the Uber app.
    • “Health plan benefit cards, including health spending account (HSA) and flexible spending (FSA) cards, can be added as a form of payment within the Uber app,” Optum and Uber said in statement released Sunday during HLTH 2023 in Las Vegas. “This payment option can then be used to cover eligible expenses, including health related rides (like non- emergency doctor visits), over-the-counter items and healthy food.”
  • Per Healthcare Dive,
    • “Rite Aid on Wednesday said it has failed to meet the New York Stock Exchange’s continued listing standards. The retailer is no longer in compliance with NYSE standards on minimum stock price and market capitalization. The NYSE listing standards require a $1.00 average closing share price over a 30 trading-day period. 
    • “As of midday Thursday, Rite Aid’s stock was trading at about 50 cents on the NYSE. Rite Aid now has 10 business days to formally confirm if it will seek to regain compliance and six months to do so. But the company said it, “can provide no assurances that it will be able to regain compliance with the NYSE’s continued listing standards.”
    • “News that Rite Aid faces delisting comes weeks after reports emerged that the company, which has $3.3 billion in debt, may seek to close up to 500 of its 2,200 locations as part of a possible Chapter 11 bankruptcy filing.”

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 6 reopened the No Surprises Act’s Independent Dispute Resolution [IDR] portal to out-of-network providers and group health plans initiating new single payment disputes under the No Surprises Act’s independent dispute resolution process, including single disputes involving bundled payment arrangements. The agency also released new guidance for processing these disputes.
    • “New and in-progress batched disputes and new air ambulance disputes remain temporarily suspended while the Departments of Health and Human Services, Labor and the Treasury update their guidance and operations to align with recent court orders, including an Aug. 24 ruling that set aside certain regulations implementing the IDR process and an Aug. 3 ruling that vacated nationwide a federal fee increase and batching rule for the process.”
  • In that regard, the federal regulators issued ACA FAQ 62 today, which focuses on No Surprises Act issues.
  • What’s more, a No Surprises Act IDR operations proposed rule is still undergoing review at OMB’s Office of Information and Regulatory Affairs.
  • BioPharma Dive informs us,
    • “The National Institutes of Health on Thursday said it will provide funding for three clinical trials of experimental ALS drugs, part of a broader push by the federal government to support the development of treatments for rare neurodegenerative diseases. * * *
    • “Until recently, the FDA had approved just two main medicines for the disease. Clinical testing had shown the drugs respectively offered modest benefits on function and survival.
    • “But in the last year or so, two more treatment options received nods from the FDA. Amylyx Pharmaceuticals’ Relyvrio is now cleared for the broad ALS population, while Biogen’s Qalsody is specifically for the small portion of patients who have mutations in a gene called SOD1.”
  • Per Pharmaceutical Technology,
    • “The US Food and Drug Administration (FDA) has issued a draft guidance to aid sponsors in developing biologics and drugs for stimulant use disorders. * * *
    • “FDA Center for Drug Evaluation and Research Substance Use and Behavioral Health deputy center director Marta Sokolowska said: “Currently there is no FDA-approved medication for stimulant use disorder. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps. 
    • “The guidance is one of the actions within the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as the development of evidence-based treatments for stimulant use disorder.”
  • Federal News Network points out,
    • “The Office of Personnel Management’s retirement claims backlog saw some improvement in September. OPM cut its backlog by 2,111 claims, hitting a new six-year low point in its overall inventory. OPM received 6,768 claims in September, and managed to process 8,879, shrinking the backlog to the lowest it has been in six years: 15,852.”
  • The Wall Street Journal reports,
    • “The U.S. Postal Service wants to raise the price of a stamp in what would be the third increase in a year.
    • “The postal service proposed a price of 68 cents, up 3% from the current price of 66 cents. If approved by the Postal Regulatory Commission, the price increase would go into effect on Jan. 21. 
    • “The agency raised stamp prices to 63 cents from 60 cents in January 2023. Six months later, the price of a stamp went up again, by 3 cents.”

From the public health and research front,

  • Medscape notes,
    • “Around 4 million Americans received the updated COVID-19 shots in September, according to the U.S. Department of Health and Human Services (HHS), even as some people have found it difficult to book vaccination appointments or find the vaccines at no cost.”
  • NBC News reports,
    • “People who take popular drugs for weight loss, such as Ozempic or Wegovy, may be at an increased risk of severe stomach problems, research published Thursday in the Journal of the American Medical Association finds.
    • “The brief report is the first study of its kind, the researchers say, to establish a link between the use of such drugs, called GLP-1 agonists, for weight loss and the risk of such gastrointestinal conditions. GLP-1 agonists include semaglutide — the drug found in Ozempic and Wegovy — and liraglutide, the drug used in Saxenda. Both drugs are made by Novo Nordisk. 
    • “Although rare, the incidence of these adverse events can happen. I’ve seen it happen,” said lead author Mohit Sodhi, a medical student at the University of British Columbia Faculty of Medicine in Vancouver. “People should know what they’re getting into.” 
  • Get a load of this good news. Per ALM Benefits Pro,
    • “World Mental Health Day is right around the corner and this year, there’s good news to share. The mental health of U.S. employees is finally on the rise nearly three years after the pandemic. A new study shared by Leapsome, a people enablement platform based in Germany, found that 88% of U.S. employees rate their mental health as being good or very good. 
    • “The massive improvements in mental health took place largely over the past year, with 47% of U.S. workers reporting that their mental health had improved within the last 12 months, according to the study.”
  • STAT News notes,
    • “The grand plan for Moderna’s future in respiratory viruses is to market a single shot that would protect against Covid-19, influenza, and RSV, using the scalability of mRNA to craft a first-of-its-kind product. And the first step — establishing the promise of its combination flu and Covid vaccine — is moving on as planned.
    • “Yesterday Moderna said its combo shot measured up to established flu and Covid vaccines in generating immune responses against each virus. The next step is to take that combination to Phase 3, which could lead to approval by 2025. At the same time, Moderna is awaiting FDA approval for its RSV vaccine and testing a combination that would protect against all three viruses.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Amgen on Friday closed its $27.8 billion acquisition of Horizon Therapeutics, about one month after securing clearance from U.S. antitrust regulators who had challenged the deal.
    • “With the acquisition’s completion, Amgen gains access to 12 drugs that had combined sales of $1.8 billion over the first six months of 2023. The company said it will update its sales guidance for the rest of the year when it reports third-quarter earnings.
    • “The deal is the largest in Amgen’s history, surpassing in dollar terms the 2001 buyout of Immunex. That acquisition gave Amgen Enbrel, a long-lasting blockbuster that, like several of its other major drugs, could lose market exclusivity in the coming years. That looming patent cliff has pushed the company to restock its pipeline via dealmaking.”
  • Per Fierce Healthcare,
    • “UnitedHealthcare’s Surest, which axes deductibles and provides upfront pricing data to members, is the fastest growing product among its commercial plan lineup. And a new analysis offers a look as to why.
    • “The insurance giant released Thursday an Impact Study examining some of the results Surest has seen to date and notes that members enrolled in these plans had 6% fewer emergency department visits and 13% fewer inpatient hospital admissions compared to those who were not enrolled in a Surest plan at the same employer.
    • “In addition, members enrolled in Surest plans had a 20% increase in visits to a physician and a 9% jump in preventive physical exams compared to those in other commercial plans.”
  • and
    • “Cigna’s Evernorth is launching a new, value-based care management program for its behavioral health network.
    • “The company said in an announcement that this marks a key step in collaboration with providers as the industry pushes for standardized benchmarks in behavioral health. About 44,000 providers will participate in the program at launch, according to Evernorth.
    • “Ultimately, if payers and providers align on how to measure success in treatment, it will drive better care, lower costs, and lead to improvements in collaboration. It should also ease administrative burdens for providers, according to the announcement, as at present they use a wide array of measures across multiple payers.”