Weekend update

Congress

Weekend update

David Ermer–Congress, Medical / Rx research, U.S. Healthcare–
Lincoln Memorial in the Fall

From Washington DC,

  • The Wall Street Journal adds.
    • “GOP lawmakers are heading into another week without a speaker will try to overcome deep divisions long enough to unify behind a new candidate, after colleagues soured on conservative firebrand Rep. Jim Jordan (R., Ohio) following a string of unsuccessful floor votes. 
    • “With the race now rebooted, nine Republican lawmakers are angling for the speaker job, jumping into the race before a Sunday deadline. 
    • “Rep. Tom Emmer (R., Minn.), who serves as the House’s majority whip, has announced a run. He already locked up an endorsement from former Speaker Kevin McCarthy (R., Calif.), who remains a popular and influential party member despite his sudden ejection from the speakership on Oct. 3. Other candidates include Kevin Hern of Oklahoma, who leads the conservative Republican Study Committee group, Byron Donalds of Florida, a political newcomer with ties to former President Donald Trump, and longtime lawmaker Pete Sessions of Texas. * * *
    • “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.”
  • The full House is scheduled to meet at 11 a.m. on Tuesday.

From the public health/research front,

  • The American Medical Association suggests seven steps that women should take to improve blood pressure control and identifies the top health tips that infectious disease doctors want their patients to know.
  • Fortune Well reports,
    • “It’s been a month since a Maryland man became the second person to receive a transplanted heart from a pig — and hospital video released Friday shows he’s working hard to recover.
    • “Lawrence Faucette was dying from heart failure and ineligible for a traditional heart transplant because of other health problems when doctors at the University of Maryland School of Medicine offered the highly experimental surgery.
    • “The Maryland team last year performed the world’s first transplant of a heart from a genetically altered pig into another dying man. David Bennett survived just two months before that heart failed, for reasons that aren’t completely clear, although signs of a pig virus later were found inside the organ. Lessons from that first experiment led to changes before this second try, including better virus testing.
    • “Attempts at animal-to-human organ transplants — called xenotransplants — have failed for decades, as people’s immune systems immediately destroyed the foreign tissue. Now scientists are trying again using pigs genetically modified to make their organs more humanlike.
    • “In Friday’s hospital video, Faucette’s doctors said the pig heart has shown no sign of rejection.”
  • Per FiercePharma,
    • “Last year, a first-of-its-kind head-to-head clinical trial between two PD-1 inhibitors went in GSK’s favor. Now, the British pharma has some new patient survival data to celebrate.
    • “Compared with Merck’s market-leading Keytruda, GSK’s Jemperli demonstrated a 25% lower risk of death in patients with newly diagnosed nonsquamous non-small cell lung cancer (NSCLC), according to new data unveiled today, Oct. 20, at the European Society for Medical Oncology (ESMO) 2023 Congress.
    • “The data come from an updated analysis of the phase 2 PERLA trial, which was the first global, head-to-head study of two PD-1 inhibitors.
    • “The number doesn’t bear statistical significance because the trial wasn’t designed to show superiority. It does, however, further prove that Jemperli behaves in a similar way as Keytruda does, Hesham Abdullah, M.D., who leads GSK’s oncology drug development, said in an interview with Fierce Pharma.”
  • MedTech Dive informs us,
    • “Shortages of medical devices and therapies are compromising patient care by delaying treatment and driving unsafe practices, according to a survey of healthcare professionals conducted by the patient safety nonprofit ECRI and the Institute for Safe Medication Practices.
    • “The survey found that supply shortages have caused surgical cases to be rescheduled, postponed or canceled and that a lack of endotracheal tubes and pulmonary artery catheters is on the cusp of impacting the ability to provide adequate clinical care.
    • “ECRI and the Institute for Safe Medication Practices used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages.”

In human resources news,

  • Per HR Dive,
    • “UPS will expand an ‘emergency child care initiative’ for U.S.-based front-line workers, the company announced Tuesday. The program, a partnership with Patch Caregiving, was piloted from August 2022 through January at a Northern California site. 
    • “According to UPS, 80% of eligible employees participated in the emergency daycare program, which helped the company avoid more than 120 unplanned absences. UPS also reported a significant reduction in employee turnover in the pilot group — from 31% to 4%.
    • “UPS will expand the program to additional shifts at the California pilot site and some Pennsylvania facilities this quarter. It will add additional facilities in 2024.”

Friday Factoids

David Ermer–CMS, Congress, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • “Rep. Jim Jordan withdrew his bid to become House speaker Friday, after the fiery conservative lost a pair of public and private votes, sending divided House Republicans back to the starting line in their weekslong quest to elect a leader and pass urgent legislation. * * *
    • “Jordan’s departure from the race has swung the door open for broader competition. Already Republican Study Committee Chairman Kevin Hern (R., Okla.) and Rep. Pete Sessions (R., Texas) had announced interest in the job, while House Majority Whip Tom Emmer (R., Minn.) was quickly endorsed by McCarthy. A handful of others also were considering bids.”
  • Healthcare Dive informs us,
    • “Sens. Kevin Cramer, D-N.D., and Angus King Jr., I-Maine, sent a letter to CMS Administrator Chiquita Brooks-LaSure on Thursday, asking the agency to withhold its controversial staffing mandate for long-term care facilities. 
    • “The CMS proposal issued last month would require nursing facilities, including veterans homes, to have at least one registered nurse on duty at all times and provide three hours of care per resident per day, with 0.55 hours coming from registered nurses. An analysis from KFF last month found 81% of nursing facilities nationwide would need to hire additional staff to meet the requirements.
    • “In the letter, the senators warned that many markets, including their home states, may not have enough nurses to meet requirements, which could cause some long-term care facilities to close and disrupt care for veterans.”
  • The American Hospital Association News announces,
    • “Oct. 28 is National Prescription Drug Take Back Day, an opportunity for the public to safely dispose of unwanted or expired tablets, capsules, patches and other solid forms of prescription drugs. The Saturday event offers free and anonymous disposal of unneeded medications at almost 5,000 local drop-off locations nationwide. Over more than 10 years, the Drug Enforcement Administration event has collected 8,650 tons of old, unwanted or expired medications, including opioid and other drugs susceptible to diversion, misuse and abuse. DEA offers posters and other materials to help hospitals and other partners promote the event in their community. Collection sites should be open from 10 a.m. to 2 p.m. local time.”

From the public health front,

  • HealthDay tells us,
    • “Two servings of red meat a week raise your risk of type 2 diabetes by 62%, new research shows.
    • “The risk applies to both processed and unprocessed red meat. 
    • “Replacing one daily serving of red meat with nuts, legumes or dairy can significantly reduce diabetes risk, researchers say.”
  • The Wall Street Journal reports,
    • “A potential blockbuster weight-loss drug still years away from U.S. regulatory approval is already being sold online, another example of a thriving gray market for unapproved weight-loss medications, according to a Wall Street Journal review.
    • “The Journal found hundreds of merchants offering the new drug, which is being developed by Eli Lilly and is called retatrutide. Most appear to be Chinese sellers shipping directly to U.S. consumers from sites such as Made-in-China.com. Some of the sites, including ones that appear to be based in the U.S., have marketed their products via posts on  Facebook, LinkedIn and Reddit. A handful have run paid ads on Instagram and Google. A fitness influencer has offered it for sale via his newsletter.  * * *
    • “In a statement, the FDA said it would continue to investigate reports of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response. 
    • “Excitement over retatrutide jumped in June when Lilly reported Phase 2 trial results that showed the drug led to an average weight loss of up to 24% over 48 weeks. That could prove better than Lilly’s already-approved drug Mounjaro. Researchers in a Lilly-funded study showed that tirzepatide, Mounjaro’s active ingredient, is the most effective medication currently being prescribed for weight loss.”  
  • The Journal adds
    • “Much of the focus has understandably been on obesity drugs’ sticker price—more than $10,000 annually—and how their usage by millions of Americans could create a budgetary crisis. 
    • “But an analysis by the American Enterprise Institute shows that the net price—what the manufacturers get—is much lower.
    • “The discount for GLP-1 drugs such as Wegovy, Ozempic, Mounjaro and Rybelsus ranged from 48% to 79%, according to the study. Ozempic, for example, is listed at $936 a month, but the manufacturer received $290 on average. Interestingly, Wegovy, currently the only one of those drugs approved by the Food and Drug Administration for obesity, had the smallest discount.
    • “Once Eli Lilly’s Mounjaro, which is approved for diabetes but frequently prescribed off-label for weight loss, gets an expected FDA nod for obesity this year, “competition for formulary placement will likely put downward pressure on net prices for those indications in that scenario,” wrote the authors of the analysis.”
  • The FEHBlog continues to believe that the prices should be lower.

From the U.S healthcare business front.

  • Per Fierce Healthcare,
    • “It shouldn’t come as much of a surprise that employers are putting a focus on managing healthcare costs in the coming year. And a new analysis from WTW highlights some of the areas in which they’re aiming to address these expenses.
    • “The consultancy surveyed 457 employers representing 7.3 million workers in June and July, and it found that 62% of firms are planning to roll out programs to address cost and mental health as part of a broader strategy around health and wellness.
    • “More than two-thirds of companies (69%) said they’ll be focusing on costs, and 63% said they’ll be addressing mental health care, according to the report.
    • “Regina Ihrke, senior director for health and benefits at WTW, told Fierce Healthcare that while employers are highly concerned about potential healthcare costs increases, they’re trying to strike a balance between managing those costs and designing a benefits package that draws in and retains top talent.”
  • and
    • “Ilant Health, a new virtual provider targeting obesity treatment, has launched out of stealth with $3 million in funding. 
    • “Founded on the belief that obesity care will only transform healthcare if it is part of the system, Ilant plans to partner with employers and payers. The startup is led by Elina Onitskansky, who previously served as senior vice president and head of strategy at Molina Healthcare.”
  • Mhealth intelligence considers whether retailers have the inside track on virtual care and identifies technologies that support payer claim processing systems.

Thursday Miscellany

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Mental health care, SCOTUS, U.S. Healthcare–
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

David Ermer–ACA, Congress, COVID treatment, Federal employment benefits, Medical / Rx research, NIH, Rx coverage, Telehealth, U.S. Healthcare–
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 Open, these 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

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

David Ermer–Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
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-B, Transmittal of Health Coverage Information Returns;
    • “(2) Form 1094-C, Transmittal of Employer-Provided Health Insurance Offer and Coverage Information Returns;
    • “(3) Form 1095-B, Health Coverage; and
    • “(4) Form 1095-C, Employer-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.

Weekend update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • The Medicare open enrollment period began today. It ends on December 7, 2023.

From the public health and research front,

  • Fortune Well informs us
    • The medicine in the diabetes drug Mounjaro [the Godzilla of GLP-1 drugs] helped people with obesity or who are overweight lose at least a quarter of their body weight, or about 60 pounds on average when combined with intensive diet and exercise, a new study shows.
    • By comparison, a group of people who also dieted and exercised but then received dummy shots lost weight initially but then regained some, researchers reported Sunday in the journal Nature Medicine.
    • “This study says that if you lose weight before you start the drug, you can then add a lot more weight loss after,” said Dr. Thomas Wadden, a University of Pennsylvania obesity researcher and psychology professor who led the study.
    • The results, which were also presented Sunday at a medical conference, confirm that the drug made by Eli Lilly & Co. has the potential to be one of the most powerful medical treatments for obesity to date, outside experts said.
  • The FDA has approved Mounjaro as a diabetes treatment but not a weight loss treatment yet.
  • The New York Times tells us,
    • “An Oxford University researcher and her team showed that digital wearable devices can track the progression of Parkinson’s disease in an individual more effectively than human clinical observation can, according to a newly published paper.
    • “By tracking more than 100 metrics picked up by the devices, researchers were able to discern subtle changes in the movements of subjects with Parkinson’s, a neurodegenerative disease that afflicts 10 million people worldwide.
    • “The lead researcher emphasized that the latest findings were not a treatment for Parkinson’s. Rather, they are a means of helping scientists gauge whether novel drugs and other therapies for Parkinson’s are slowing the progression of the disease.”
  • The Washington Post interviews “physician Rosanne Leipzig, vice chair for education at the Brookdale Department of Geriatrics and Palliative Medicine at the Icahn School of Medicine at Mount Sinai in New York.” Dr. Leipzig is the author of “Honest Aging: An Insider’s Guide to the Second Half of Life.” The reporter described the book as “the most comprehensive examination of what to expect in later life I’ve come across in a dozen years covering aging.”
  • The Washington Post also reports,
    • “The United States faces a “bloody transfusion problem” that is fueling preventable deaths and putting national security at risk, three military and civilian physicians write in a JAMA opinion essay.
    • “The JAMA op-ed, published Oct. 12, highlights blood transfusions’ importance in emergency care. Emergency transfusions can decrease deaths, especially when given early, the physicians write. But not enough healthcare facilities and emergency vehicles are equipped for the procedures, they add, which presents a “substantial risk to our nation’s security infrastructure.”
    • “One reason is the national blood supply, which the writers call “tenuous” because of its reliance on volunteers, as well as problems with blood storage and the places where blood is collected and processed.
    • “The physicians cite a 2020 Health and Human Services report that characterized the national blood supply system as “struggling.” That report said blood availability is hindered by issues with donor recruitment, an aging donor population and problems funding collection centers.”

From the U.S. healthcare business front,

  • MedTech Dive points out,
    • “Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales.”Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales.
    • “The company plans to sell the Dexcom G7 CGM at launch and is looking to offer additional CGM systems from other manufacturers, according to the company.
    • “Customers who want to buy a CGM will be routed to the virtual care platform Wheel, where clinicians will determine a patient’s eligibility and write a prescription. Pharmacy tech provider HealthDyne will receive and process prescriptions, and consumers can then purchase the CGMs on Best Buy’s website for home delivery.”
  • BioPharma Dive notes,
    • “Pfizer said on Friday afternoon it plans to cut billions of dollars in spending and lay off staff as it adjusts to lower demand for its COVID-19 drug Paxlovid and vaccine Comirnaty. 
    • “The pharmaceutical company is also significantly revising down its revenue forecast to between $58 billion and $61 billion for the year, a $9 billion cut from its previously issued guidance. 
    • “The bulk of that adjustment is due to the return by the U.S. governmentof nearly 8 million treatment courses of Paxlovid labeled under the drug’s emergency clearance. Distribution of that product will be stopped in November as Pfizer shifts to selling Paxlovid commercially, which it now expects to begin on a wide scale in January. The antiviral treatment won full U.S. approval in May.”

Friday Factoids

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

    From Washington DC

    • The Wall Street Journal reports,
      • “House Republicans chose Rep. Jim Jordan (R., Ohio) as their nominee for speaker, but it remained uncertain whether the fiery ally of former President Donald Trump could avoid the fate of Steve Scalise (R., La.), who also won an internal ballot but then failed to win enough broad party support to claim the gavel. * * *
      • “House Republicans will now break for the weekend with a plan to bring a vote on elevating Jordan to the speakership once they get back, giving him a few days to win over his critics.
      • “I think I can unite the conference,” Jordan said, with supporters pointing to his popularity among grass-roots Republicans.”
    • Govexec informs us,
      • “A bipartisan pair of senators on Thursday proposed legislation that would codify federal employees’ use of remote work in federal law, as well as establish stronger reporting and training requirements for telework and authorize the noncompetitive hiring of military and law enforcement spouses into remote work positions.
      • “The Telework Reform Act (S. 3015), introduced by Sens. James Lankford, R-Okla., and Kyrsten Sinema, I-Ariz., codifies the Office of Personnel Management’s administratively determined definitions of telework and remote work—including the requirement that teleworkers commute to their traditional worksite at least twice per pay period—and institutes a barrage of new reporting requirements for agencies.”
    • The Department of Health and Human Services tells us,
      • “HHS and Pfizer have reached an agreement that extends patient access to Paxlovid, maximizes taxpayer investment, and begins Paxlovid’s transition to the commercial market in November 2023. This agreement builds on HHS and Pfizer’s strong partnership over the last three years that enabled the development, manufacture, and distribution of COVID-19 vaccines and therapeutics at a record pace.
      • “HHS has consistently expressed a shared interest in jointly transitioning Paxlovid to the commercial market while ensuring that the United States taxpayer continues to receive fair and reasonable benefit from the HHS procurement of this product, with a focus on ensuring affordable access for beneficiaries in public programs like Medicare and Medicaid as well as for those who are uninsured. Per the agreement announced today, HHS and Pfizer will begin preparations for Pfizer to transition Paxlovid to the commercial market in November 2023.”
    • NBC News adds
      • “A consensus has emerged among experts who study and treat long Covid: Paxlovid seems to reduce the risk of lingering symptoms among those eligible to take it.
      • “The idea is intuitive, experts say. Paxlovid prevents the coronavirus from replicating, so researchers think it may also reduce the risk of an infection causing inflammation or organ damage, which in turn can lead to chronic illness.
      • “Clinical observations and a large study published in March support that theory. Among the 282,000 people in the study who were eligible for Paxlovid, the drug was associated with a 26% lower risk of long Covid. 
      • “Research definitely backs up that it helps prevent lingering symptoms — it helps prevent long Covid,” said Ashley Drapeau, director of the Long Covid Clinic at the GW Center for Integrative Medicine.”
    • In preparation for the beginning of the Medicare Open Enrollment period on October 15, 2023, the Centers for Medicare and Medicaid Services “released the 2024 Star Ratings for Medicare Advantage (Medicare Part C) and Medicare Part D to help people with Medicare compare health and prescription drug plans * * *.
    • Fierce Healthcare adds,
      • “Approximately 42% of Medicare Advantage plans that offer prescription drug coverage will have a star rating of four or more in 2024, marking yet another substantial decrease from 51% in 2023 and 68% in 2022.”

    In FEHB open season news,

    • The Federal Times offers advice on how to prepare for making Open Season decisions. Surprisingly, the report does not suggest comparing summaries of benefits and coverage which are a product of the Affordable Care Act.
    • Federal News Network provides a helpful interview with John Hatton, a knowledgeable NARFE executive.

    From the public health service front,

    • The New York Times reports,
      • “Over the last several decades, the rates of new cases of lung cancer have fallen in the United States. There were roughly 65 new cases of lung cancer for every 100,000 people in 1992. By 2019, that number had dropped to about 42.
      • “But for all that progress, a disparity is emerging: Women between the ages of 35 and 54 are being diagnosed with lung cancer at higher rates than men in that same age group, according to a report published Thursday by researchers at the American Cancer Society. The disparity is small — one or two more cases among every 100,000 women in that age range than among men — but it is significant enough that researchers want to know more.
      • “The report adds to a mounting body of evidence that emphasizes the lung cancer risks for women in particular.
    • BioPharma Dive points out,
      • “The Food and Drug Administration on Friday approved Pfizer’s Velsipity to treat ulcerative colitis, making it the second pill of its type cleared for use in inflammatory bowel disease, the company said. Velsipity enters a market with several oral and injectable drugs which block the immune response that causes the disease, including one in its class, Bristol Myers Squibb’s Zeposia.
      • “Pfizer acquired the medicine through its $6.7 billion buyout of Arena Pharmaceuticals in 2021. The big drugmaker hopes Velisipity, which slows the entry of white blood cells into the bloodstream, can also work in other immune-related conditions like Crohn’s disease, alopecia areata and eczema.
      • “Pfizer expects to add $25 billion in revenue by 2030 from new products acquired through biotech buyouts and licensings. The additional revenue will help cushion the company against revenue declines from its COVID-19 products as well as loss of patent protection for older drugs.”
    • Per Fierce Healthcare,
      • “The Centers for Medicare & Medicaid Services has decided to remove the national coverage determination (NCD) that limits patients’ ability to qualify for new drugs, giving people with Alzheimer’s symptoms a better path to treating the condition.
      • “The policy means that amyloid PET scans will no longer be limited and will give patients a better chance of being prescribed a drug like Leqembi or Eisai, which clears beta amyloid proteins from the brain to slow the advances of Alzheimer’s.”
    • The National Institutes of Health announced,
      • Reducing overall calorie intake may rejuvenate your muscles and activate biological pathways important for good health, according to researchers at the National Institutes of Health and their colleagues. Decreasing calories without depriving the body of essential vitamins and minerals, known as calorie restriction, has long been known to delay the progression of age-related diseases in animal models. This new study, published in Aging Cell, suggests the same biological mechanisms may also apply to humans.
      • “Researchers analyzed data from participants in the Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE), a study supported by the National Institute on Aging (NIA) that examined whether moderate calorie restriction conveys the same health benefits seen in animal studies. They found that during a two-year span, the goal for participants was to reduce their daily caloric intake by 25%, but the highest the group was able to reach was a 12% reduction. Even so, this slight reduction in calories was enough to activate most of the biological pathways that are important in healthy aging.
      • “A 12% reduction in calorie intake is very modest,” said corresponding author and NIA Scientific Director Luigi Ferrucci, M.D., Ph.D. “This kind of small reduction in calorie intake is doable and may make a big difference in your health.”
    • Health IT Analytics notes,
      • The American Health Information Management Association (AHIMA) announced its Data for Better Health initiative, which aims to revolutionize healthcare through the use of social determinants of health (SDOH) data, this week at the organization’s annual conference, AHIMA23.”

    From the U.S. healthcare business front,

    • Mercer Consulting calls our attention to the “Top 10 health, leave benefit compliance and policy issues in 2024.”
    • Per Healthcare Dive,
      • “UnitedHealth Group reported third-quarter earnings on Friday that beat Wall Street expectations as the payer posted a lower-than-feared medical loss ratio. The insurer’s stabilizing medical costs followed an unexpected surge in outpatient utilization for seniors earlier this year that spooked investors.
      • “The payer’s MLR — the share of premiums spent on healthcare costs — was 82.3%. Medical costs were up compared to 81.6% last year but lower than 83.2% in the second quarter. UnitedHealth expects its medical costs to rise in the fourth quarter as patients weather seasonal illnesses and other factors, said UnitedHealth CFO John Rex on a Friday earnings call.
      • “UnitedHealth raised its 2023 adjusted net earnings per share outlook by about 1% to $24.85 to $25, up from its prior projections of $24.70 to $25. The insurer reported $8.5 billion of profit on revenue of $92.4 billion for the third quarter.”
    • The Wall Street Journal reports,
      • “Health system Kaiser Permanente reached a tentative agreement with unions that would raise wages and increase investment in staffing.
      • “The deal, which the sides announced Friday, would increase wages by 21% over four years, the unions and employer said. Now, it must be ratified by the workers before terms take effect.
      • “If the workers go along, the agreement would end a dispute that led to the largest healthcare labor action on record and prevent a second work stoppage at one of the biggest health systems in the U.S.”

    Thursday Miscellany

    David Ermer–Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
    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 sleep, exercising 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.” 

    Midweek Update

    David Ermer–Congress, FDA, Generative AI, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
    Photo by Manasvita S on Unsplash

    From Washington, DC

    • Roll Call reports
      • “House Majority Leader Steve Scalise’s bid for speaker was on shaky ground Wednesday as Republicans went back behind closed doors to figure out next steps even after selecting the Louisianan as their nominee during a morning conference meeting.
      • “Several conservatives said they won’t support Scalise on the floor, even as his top rival for the job, Judiciary Chairman Jim Jordan, R-Ohio, is supporting him and encouraging others to do so. Instead of kicking off the formal nominating speeches and votes on the floor Wednesday after coming into session at 3 p.m., Speaker Pro Tempore Patrick T. McHenry recessed the chamber.” * * *
      • “The House adjourned for the night before 7 p.m. An advisory from House Democrats said votes were “possible” Thursday, and the chamber is scheduled to gavel back into session at noon.”
    • On September 18, 2023, the Senate Health Education Labor and Pensions Committee will hold a hearing on the nomination of Dr. Monica Bertagnolli to be Director of the National Institutes of Health.
    • Govexec tells us,
      • “The Biden administration on Wednesday released a new requirement for agencies throughout government to think more carefully about expanding competition through their regulatory actions. 
      • “President Biden has targeted antitrust trends in the economy as a key part of his domestic agenda and the White House said the new guidance will help enforce those efforts through an “all-of-government approach to competition.” The Office of Information and Regulatory Affairs document creates frameworks for agencies as they develop and analyze potential regulatory actions. 
      • “OIRA noted that agencies can shape markets through their regulations and urged them to draft those rules to enhance competition.” 
    • Federal New Network explores the role of Janice Underwood, the first-ever governmentwide chief diversity officer and a senior leader at the Office of Personnel Management.

    From the public health and research front,

    • KFF informs us,
      • “Sepsis, the body’s extreme response to an infection, affects 1.7 million adults in the United States annually. It stems from fungal, viral, or bacterial infections, similar to what struck Madonna this year, although the singer never said whether she was diagnosed with sepsis. Treatment delays of even a few hours can undermine a patient’s chance of survival. Yet sepsis can be difficult to diagnose because some patients don’t present with common symptoms like fever, rapid heart rate, or confusion.
      • “A Biden administration rule, finalized in August, ups the ante for hospitals, setting specific treatment metrics that must be met for all patients with suspected sepsis, which could help save some of the 350,000 adults who die of infections annually. Children, too, are affected, with some estimates that 75,000 are treated each year for sepsis, and up to 20% of them die. Hospitals that fail to meet the requirements risk losing potentially millions in Medicare reimbursement for the year.
      • “Still, because the rule applies broadly, it has triggered pushback for its lack of flexibility.
      • “Efforts to reduce sepsis deaths are welcome, but “where it gets controversial becomes ‘Is this the best way to do it?’” said Chanu Rhee, an infectious disease physician and associate professor of population medicine at Harvard Medical School.”
    • Reuters reports,
      • “Novo Nordisk (NOVOb.CO) said on Tuesday it will stop a trial studying Ozempic to treat kidney failure in diabetes patients ahead of schedule because it was clear from an interim analysis that the treatment would succeed.
      • “Novo said the trial would be halted almost a year early based on a recommendation from the independent data monitoring board overseeing the study. Independent monitors can recommend stopping a trial early if there is clear evidence that a drug is going to succeed or fail based on interim analyses. * * *
      • “The Danish drugmaker said the trial was testing whether the widely used diabetes drug, which contains the active ingredient semaglutide, could delay the progression of chronic kidney disease and lower the risk of death from kidney and heart problems.
      • “Semaglutide is also the active ingredient in Novo Nordisk’s powerful weight-loss drug Wegovy.
      • “Barclays analyst Emily Field said in a note that the company’s decision affirmed the view that GLP-1 receptor agonists like Ozempic have “therapeutic benefits far beyond their original intended purpose.”
      • FEHBlog note — Why then doesn’t Novo Nordisk lower the price of this apparent cure-all?
    • Medscape adds,
      • “People taking semaglutide or liraglutide for weight management are at a higher risk for rare but potentially serious gastrointestinal issues, compared with those taking naltrexone/bupropion, according to a large epidemiologic study.
      • “Patients” taking either of these glucagon-like peptide-1 (GLP-1) receptor agonists had nine times an elevated risk for pancreatitis. They were also four times more likely to develop bowel obstruction and over 3.5 times more likely to experience gastroparesis.
      • “The research letter was published online today in the Journal of the American Medical Association.
      • “Investigators say their findings are not about scaring people off the weight loss drugs, but instead about increasing awareness that these potential adverse outcomes can happen.
      • “* * * People taking a GLP-1 agonist to treat diabetes might be more willing to accept the risks, given their potential advantages, especially for lowering the risk for heart problems, said Mahyar Etminan, PharmD, MSc, the study’s senior author and an expert in drug safety and pharmacoepidemiology at UBC. “But those who are otherwise healthy and just taking them for weight loss might want to be more careful in weighing the risk–benefit equation.”
      • “People taking these drugs for weight loss have an approximately 1%–2% chance of experiencing these events, including a 1% risk for gastroparesis, Etminan said.”
    • The Brown & Brown consulting firm offers a four-step plan for employer action to “focus on their benefits, helping to enable employees with easy access to preventive care, early detection, navigation and support specific to breast cancer.
    • The New York Times points out,
      • “The Food and Drug Administration issued an alert on Tuesday about the dangers of treating psychiatric disorders with compounded versions of ketamine, a powerful anesthetic that has become increasingly popular among those seeking alternative therapies for depression, anxiety, post-traumatic stress disorder and other difficult-to-treat mental health problems.”
    • and
      • “A new AI tool diagnoses brain tumors on the operating table;
      • “A new study describes a method for faster and more precise diagnoses, which can help surgeons decide how aggressively to operate.”

    From the U.S. healthcare business front,

    • The VTDigger lets us know that following regulatory approval, “Blue Cross Blue Shield of Vermont can now move forward with an agreement that will make the Berlin-based nonprofit a subsidiary of the much larger Blue Cross Blue Shield of Michigan.”
    • Per Fierce Healthcare
      • “Des Moines, Iowa-based UnityPoint Health and Albuquerque, New Mexico-based Presbyterian Healthcare Services are no longer working toward a merger, the systems announced Wednesday.”
    • and
      • A new analysis finds that more pharmacists are electronically prescribing medications as they assist in managing chronic disease, which offers a peek at the next evolution in primary care.
      • * * * Lynne Nowak, M.D., Surescripts’ first chief data and analytics officer, told Fierce Healthcare in an interview at HLTH that the findings highlight the potential pharmacists and other clinicians have in addressing those access gaps.
      • “We’re not saying that pharmacists should be doing the job of a physician,” Nowak said. “They’re not trying to replace them, but just looking at this broader view of a care team and ensuring they’re all connected.”
    • STAT News reports,
      • “Bruce Broussard, CEO of health insurance giant Humana, will step down next year after leading the company for more than a decade.
      • “Humana named Jim Rechtin — who is the CEO of Envision Healthcare, the controversial physician staffing firm that is working its way through bankruptcy — as Broussard’s replacement. Rechtin will serve as president and chief operating officer starting Jan. 8 and then take over as CEO in the “latter half of 2024,” the company said in a news release.”
    • Per Healthcare Dive,
      • “Walgreens has named former Cigna executive Tim Wentworth as its new chief executive officer, the retail pharmacy company announced late Tuesday.
      • “Wentworth is replacing Roz Brewer a little over a month after she announced her unexpected departure from Walgreens.
      • “Wentworth, who will become Walgreens CEO effective Oct. 23, is the former CEO of Express Scripts, the pharmacy benefit manager acquired by Cigna in 2018. At Cigna, he led the health services business Evernorth.”
    • and
      • “CVS Health wants to create a “super app” connecting multiple omnichannel modalities of the healthcare experience, including benefits, delivery and retail channels, chief medical officer Sree Chaguturu said Tuesday at the HLTH conference in Las Vegas.
      • “A super app is a widely adopted mobile or web application that combines multiple services in one platform. Super apps are ubiquitous in Asia, but haven’t taken off in the U.S. due to a fragmented app market, concerns about advertising revenue, the country’s payment system structure and a strict regulatory environment, according to the Harvard Business Review.”
    • The WTW consulting firm offers an infographic displaying the results of their employer survey of Best Practices in Healthcare.