Monday Roundup

Medicare

Monday Roundup

David Ermer–CMS, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • CMS issued a World AIDS HIV Day Fact Sheet today.
    • “Approximately 1.2 million people in the United States are living with HIV, which disproportionately affects men and underserved communities. While it was once a deadly diagnosis, HIV is now a health condition that people can manage through their lifetimes with access to safe, appropriate, high-quality treatment and support services. Thanks to the advancement of science, U=U, or undetectable equals untransmittable, means that people with HIV with an undetectable viral load cannot sexually transmit the virus to others, transforming lives and reducing stigma.
    • “The Centers for Medicare & Medicaid Services (CMS) is proud to celebrate World AIDS Day 2024 with the theme “Collective Action: Sustain and Accelerate HIV Progress” through our continuous focus to provide affordable, accessible, high-quality care to all individuals enrolled in our programs, including people with HIV/AIDS. CMS is helping to drive progress across each of its strategic pillars and its commitment to advance equity, expand access, engage partners, drive innovation, protect programs, and foster excellence.”
  • Per a House of Representatives press release,
    • “Today, the Select Subcommittee on the Coronavirus Pandemic concluded its two-year investigation into the COVID-19 pandemic and released a final report titled “After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward.” * * *
    • “On Wednesday, December 4, 2024, at 10:30am, the Select Subcommittee will hold a markup of the final report and officially submit the report to the Congressional record. Ahead of the markup, the Select Subcommittee will also release additional supporting materials and recommendations.
    • “The full, 520-page final report can be found here.”
    • The Committee’s summary of the final report can be found in the press release.
  • My Federal Retirement discusses the health reimbursement account tools found in consumer driven FEHB and PSHB plans.
  • Modern Healthcare reports,
    • “UnitedHealthcare and Centene have received higher Medicare Advantage star ratings for the 2025 plan year after the Centers for Medicare and Medicaid Services revised their scores.
    • “On Monday, CMS published updated Medicare Advantage Star Ratings program data that reveal the agency increased the quality ratings for 12 UnitedHealthcare contracts and seven Centene contracts, each of which comprise multiple Medicare Advantage plans. CMS issued 2025-star ratings for all Medicare Advantage insurers in October.” * * *
    • “Centene gained its sole four-star contract under the recalculations CMS disclosed Monday. Two UnitedHealthcare contracts were upgraded to five stars and three to four stars, giving the UnitedHealth Group subsidiary 37 contracts rated at least four stars.
    • “The U.S. District Court for the Eastern District of Texas ordered CMS to redo UnitedHealthcare’s scores last month in a case involving how the agency evaluated the company’s call center services. Centene initiated a similar lawsuit in October, which is still on the docket, as is a complaint from Humana. Elevance Health and Blue Cross and Blue Shield of Louisiana sued over their scores on different grounds.”

From the public health and medical research fronts,

  • STAT News explores “Why have U.S. bird flu cases been so mild?” Here are the hypotheses considered in the article:
    • “Hypothesis: The way in which the virus is being transmitted — along with the amount of virus exposure — is limiting the severity of disease
    • “Hypothesis: The version of H5N1 circulating in the U.S., the 2.3.4.4b clade, is inherently less dangerous to people.”
    • “Hypothesis: People are less susceptible to severe infection from H5N1 than we used to be.”
    • “Hypothesis: Public health officials were previously unaware of a significant number of mild H5N1 cases in humans, leading to a dramatic overestimation of H5’s feared case fatality rate. Only now are we getting a true picture of the spectrum of infection.”
  • Per BioPharma Dive,
    • “The American Diabetes Association, a high-profile advocacy group, is warning against widespread use of compounded versions of popular weight loss and diabetes drugs like Wegovy and Zepbound.
    • “The group on Monday released an official guidance statement that recommends doctors avoid prescribing unapproved, off-brand versions of the medicines, which have been so in demand their manufacturers, Novo Nordisk and Eli Lilly, have had difficulty keeping up supply.
    • “We urge health care professionals to consider this guidance statement due to concerns around the safety, quality, and effectiveness of compounded versions of these products,” said Joshua Neumiller, the ADA’s president-elect and a co-author of the statement.”
  • The New York Times proposes five questions to ask your doctor when deciding whether to undergo a hysterectomy.
  • Medscape tells us,
    • “Novocure said on Monday its experimental therapy extended the lives of patients with a form of advanced pancreatic cancer when combined with chemotherapy, achieving the primary goal in a late-stage trial.
    • “The therapy uses Tumor Treating Fields, or electric fields, to kill cancer cells while sparing most nearby healthy cells, using a portable device placed on the skin near the tumor.
    • ‘In the study, TTFields therapy concomitant with chemotherapy helped patients live for an average of 16.20 months, compared to 14.16 months in patients treated with chemotherapy alone, Novocure said.
    • ‘The treatment’s safety was consistent with prior clinical studies, the company said.
    • “The therapy also helped improve survival rates over time, according to Novocure. The rate of overall survival, or the length of time a patient lives from the start of treatment, improved by 13% at 12 months and by 33% at 24 months, the company said.”
  • and
    • “Individuals with normal body mass index (BMI) measurements may still face an increased risk for colorectal cancer (CRC) if they have central obesity, characterized by excess fat around the abdomen.”
  • Consumer Reports, writing in the Washington Post, points out “tools to help you remember when to take pills. Poor medication adherence results in an estimated 125,000 deaths each year.

From the U.S. healthcare business front,

  • Fierce Healthcare honors ten women of influence in healthcare. Kudos to them.
  • Modern Healthcare reports,
    • “GE HealthCare will take on full ownership of the drug company Nihon Medi-Physics in a transaction with Sumitomo Chemical that is expected to close in early 2025, the company announced Monday.
    • “Nihon Medi-Physics’ portfolio includes radiopharmaceuticals for neurology, cardiology and oncology that are used in clinical imaging to help diagnose Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies and coronary artery disease. The GE HealthCare-Sumitomo Chemical is subject to regulatory review and the companies did not disclose the terms of the deal.
    • “GE HealthCare has owned half of Nihon Medi-Physics since 2004, when former parent company General Electric obtained the stake as part of its acquisition of drugmaker Amersham.”
  • and
    • “Community Health Systems’ Northwest Healthcare acquired 10 urgent care centers in Arizona from Carbon Health.
    • “The transaction grows Northwest’s network across the Tucson, Arizona, area to more than 80 care sites, according to a Monday news release. One of the 10 centers was not in operation when the deal closed and is awaiting a certificate of occupancy from the state of Arizona, a CHS spokesperson said.
    • “Financial details of the deal were not disclosed.”
  • Beckers Hospital Review informs us,
    • “Pittsburgh-based UPMC reported an operating loss of $57.6 million (-0.7% margin) in the third quarter ended Sept. 30, 2024, up from a $191 million operating loss (-2.8% margin) reported during the same time period in 2023, according to the system’s most recent financial report.”
  •  and
    • “Despite an end to the recent IV fluid shortage being in sight, hospital administrators may continue to adjust standard practices, KFF Health News reported Nov. 27.”  * * *
    • “Falls Church, Va.-based Inova Health System’s chief of research stewardship, Sam Elgawly, MD, told KFF Health News that the system has dropped its IV fluid usage by 55% since early October.
    • “There has been increasing literature over the last 10 to 20 years that indicates maybe you don’t need to use as much,” Dr Elgawly told KFF Health News. “[The shortage] accelerated our sort of innovation and testing of that idea.”
    • “Read the full KFF Health News report here.”
  • Per BioPharma Dive,
    • “Novartis could pay close to $3 billion for brain drugs developed by PTC Therapeutics, per a deal announced Monday.
    • “At the center of the deal is an experimental medicine, PTC518, which is currently being tested as a potential treatment for Huntington’s disease in a roughly 250-person clinical trial. The main portion of that study should complete early next year. But ahead of those results, PTC has entered into an exclusive licensing agreement that gives Novartis rights to the medicine as well as related molecules.
    • “The deal is set to close before the end of March, according to the companies. If it does, PTC will get $1 billion upfront. The New Jersey-based drugmaker could receive milestone payments worth up to $1.9 billion, in addition to royalties on any PTC518 sales outside the U.S.”
  • and
    • “Swiss pharmaceutical giant Roche is spending around $1 billion to acquire a San Diego-based biotechnology company that’s trying to treat certain cancers and rare diseases with a slate of cell therapies and genetic medicines.
    • “The deal, announced Tuesday, has Roche paying $9 per share of Poseida Therapeutics. Poseida investors may additionally receive as much as $4 per share more via a so-called contingent value right if the biotech’s drug programs hit specific research and commercial milestones. The acquisition is expected to close sometime between January and the end of March.
    • “The two companies were already working together through a licensing agreement inked in 2022. Terms of the new deal suggest Roche sees even more promise in Poseida’s gene editing technologies, which are being used to create allogeneic, or “off-the-shelf,” cell therapies that don’t rely on a patient’s own donor cells. Roche’s offer is 215% above Poseida’s closing share price on Monday — representing one of the largest premiums paid in a big-ticket biopharma acquisition over the past several years.”

Friday Factoids

David Ermer–CDC, CMS, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC

  • Federal News Network points out three reasons why federal and postal employees and annuitants should consider their FEHB plan options before Open Season ends on December 9.
  • FedWeek updates its Open Season FAQs for the benefit of Postal employees and annuitants.
  • The Government Accountability Office released a report comparing employer sponsored plans against Affordable Care Act marketplace plans.
    • “In 2023, about 165 million individuals in the U.S. got their health coverage through an employer and about 16 million got coverage through Affordable Care Act Marketplaces.
    • “Comparing the costs of these plans isn’t straightforward. For example, people with employer-sponsored plans pay their premiums with pre-tax dollars. People with Marketplace plans pay their premiums with after-tax dollars. Other factors (e.g., geographic area, level of coverage) can also affect costs.
    • “We estimated that people with employer-sponsored plans had lower average premiums, but their average contributions to those premiums were higher than those in Marketplace plans.”
  • Beckers Payer Issues informs us,
    • “Some insurers are sounding the alarm that Medicare coverage of weight loss drugs could increase premiums. 
    • “On Nov. 26, CMS issued its proposed rule for Medicare Advantage plans in 2026. The rule included a proposal to allow the program to pay for weight loss drugs for individuals with obesity. 
    • “The coverage would also extend to Medicaid beneficiaries. The White House estimated more than 7 million people would be eligible for weight loss drugs if coverage is expanded. 
    • Ceci Connolly, president of the Alliance of Community Health Plans, called the proposal “irresponsible, without further analysis and stakeholder engagement.” 
    • “We are deeply concerned with the proposed coverage expansion of weight-loss drugs in Medicare and Medicaid,” Ms. Connolly said. “The excessive prices drugmakers command for GLP-1s have enormous cost consequences for consumers, taxpayers and employers.” 
    • “The organization represents 30 nonprofit health plans.”
  • STAT News reports,
    • “Bristol Myers Squibb has filed a lawsuit accusing the Biden administration of unlawfully preventing the company from using rebates to pay hospitals that participate in a federal drug discount program, the fourth large pharmaceutical company to attempt a change in payment terms in recent weeks.
    • “The drugmaker sought that move for its widely prescribed Eliquis blood thinner, but the U.S. Department of Health and Human Services maintained such a switch would violate federal law. The agency recently made the same determination in rejecting moves by Johnson & Johnson and Eli Lilly to change payment terms, both of which filed lawsuits. Sanofi also wants to change payment terms but has not filed a lawsuit.
    • ‘In its lawsuit, Bristol argued that the 340B Drug Discount Program is rife with waste and abuse. The program was created three decades ago to help hospitals and clinics care for low-income and rural patients. Drug companies that want to take part in Medicare or Medicaid must offer their medicines at a discount — typically, 25% to 50%, but sometimes higher — to participating hospitals and clinics.
    • “However, Bristol had an additional motive for filing its suit. Eliquis was selected by Medicare for price negotiations. And the agency wants manufacturers to ensure the 340B discount and maximum fair price under the Inflation Reduction Act are not applied to the same drug. By offering rebates instead of discounts, the company is trying to avoid this conundrum. J&J stated the same concern in its lawsuit.”

From the public health and medical research front,

  • The Wall Street Journal tells us,
    • “More than 1 in 4 people over age 65 fall each year. Earlier this month, the veteran TV host and comedian Jay Leno was one of them. Leno, 74, left his hotel near Pittsburgh looking for a bite to eat. It would have been a long walk to the restaurant, so he took a shortcut down a grassy hill. A tumble on the slope left him with a broken wrist and significant bruises to his face and entire left side. 
    • “Leno still managed to do his comedy act that night. He was luckier than many fall victims. Every year falls among older Americans result in about 3.6 million emergency room visits and 1.2 million hospital stays, at a cost of roughly $80 billion. Nationwide, 41,000 senior citizens die from falls annually, according to the Centers for Disease Control and Prevention. In recent years, prominent figures such as comedian Bob Saget, former Connecticut Sen. Joe Lieberman and Ivana Trump died after a fall.
    • “And despite progress in care and prevention techniques, a University of Michigan study found that the number of falls goes up about 1.5% every year. “It could be that efforts aren’t working—or that they are, by mitigating even worse potential injury risk in the population,” said Geoffrey Hoffman, a gerontologist at the University of Michigan. “Either way, more investment in prevention and funding for fall education and prevention programs would help.” 
    • “The CDC operates a program known as STEADI (Stopping Elderly Accidents, Deaths and Injuries) to assist healthcare providers in screening older patients for fall risk factors, such as a history of falls, vision problems, inadequate vitamin D intake and foot problems. In one common test, the patient must get up from a chair, walk 10 feet, turn around, walk back and sit down. If this takes more than 12 seconds, they are deemed to be at risk for a fall.
    • “Earlier this year, Rep. Carol Miller of West Virginia, a Republican, introduced legislation to make fall-risk assessment part of Medicare’s annual wellness benefit for all seniors. The bill, known as the SAFE Act, would also direct the Department of Health and Human Services to report annual statistics about falls to Congress.”
  • Medscape discusses new data supporting the most promising treatments for long Covid.
  • Per an NIH press release,
    • “Children of mothers who took certain antiseizure medications while pregnant do not have worse neurodevelopmental outcomes at age 6, according to a long-running study funded by the National Institutes of Health (NIH). The study was published in JAMA Neurology.
    • “Controlling seizures during pregnancy is an important part of prenatal care for women with epilepsy, but for years, the effects of newer antiseizure medications on their children was unknown,” said Adam Hartman, M.D., program director at NIH’s National Institute of Neurological Disorders and Stroke (NINDS). “One major component of this study was correlating the cognitive abilities of children with maternal blood levels of the drugs. This opens the door to future work and might inform better dosing strategies.”
    • “Treating epilepsy during pregnancy is challenging, as some antiseizure medications, primarily older drugs such as valproate, are known to cause serious birth defects and cognitive problems in children, including lower IQ and autism spectrum disorders. Newer antiseizure drugs that are widely used today are generally considered safe, but little is known about whether they affect cognition in children after fetal exposure.”
  • The Washington Post reports,
    • “A farm that supplies organic, pasture-raised eggs for Costco has issued a recall for more than 10,000 products sent to 25 retail locations in five southern states.
    • “Handsome Brook Farms said the eggs, which were sold in packs of 24 under the label of Kirkland Signature, could be contaminated with salmonella. The recalled eggs were sent to Costco stores in Alabama, Georgia, North Carolina, South Carolina and Tennessee, the farm said. The affected products were sent beginning Nov. 22 and bear the UPC 9661910680, along with the code 327 and a “use by” date of Jan. 5, 2025, printed on the side.
    • “Handsome Brook Farms, which is working with the Food and Drug Administration on the recall, said no one has reported being sickened by the eggs. Salmonella is a bacteria that can cause diarrhea, fever and abdominal cramps, according to the FDA. More severe cases can be fatal, and children, elderly people and those with weakened immune systems are more vulnerable to more acute infections.”
  • NBC News adds,
    • “An Arizona produce company is recalling all sizes of its whole, fresh American cucumbers in 26 states and parts of Canada because they could be contaminated with salmonella, it said.
    • “SunFed said in an announcement posted online Thursday by the Food and Drug Administration that cucumbers it sold from Oct. 12 to Nov. 26 were recalled because of the potential contamination, which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.
    • “The recalled cucumbers were packaged in bulk cardboard containers marked with the SunFed label or in generic white boxes or black plastic crates with stickers naming the grower, according to the company.
    • “The produce was distributed in 26 states: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Maryland, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.”
  • The CDC notes that “Due to the Thanksgiving holiday, the weekly respiratory virus data and summaries will not update on Friday, November 29, 2024. Data updates will resume on Monday, December 2, 2024.”  Lo siento.

From the U.S. healthcare business front,

  • Health Affairs Scholar lets us know,
    • As policymakers continue to grapple with rising health care costs and prices, understanding trends and variations in inpatient prices among hospital characteristics is an important benchmark to allow policymakers to craft targeted policies. In this study, we provide descriptive trends on variation in inpatient prices paid by commercial health plans stratified by hospital characteristics using data from Health Care Cost Institute’s employer-sponsored insured claims data.
    • Our analyses found evidence of considerable variation among inpatient price levels and growth among system affiliation and profitability. Prices among system-affiliated hospitals grew from $14,281.74 in 2012 to $20,731.95 in 2021, corresponding to a 45.2% increase during this period. On the other hand, prices among independent hospitals grew more slowly, from $13,460.50 in 2012 to $18,196.90 in 2021, corresponding to a 35.2% increase.
    • We did not observe a similar trend in growth rates among case mix index by hospital characteristics, implying that differential inpatient price growth is not driven by changes in case mix by hospital characteristics. Heterogeneity in hospital prices and price growth by type of hospital suggests that public and private policymakers aiming to rein in health spending should consider policies that address this variation.
  • Per BioPharma Dive
    • “For drug companies, predicting how much money a product will make is a risky endeavor. If the estimate ends up being far off, then investors may question how well a developer understands its own business or the markets in which it operates. That’s especially true when the prediction is too high.
    • “Analysts on Wall Street were therefore surprised last month to hear Intra-Cellular Therapies, which never much entertained this guessing game, say that its brain-rebalancing drug Caplyta would reach $5 billion in annual sales sometime in the next decade. This year alone, the New Jersey-based company expects $665 million to $685 million in net product sales from Caplyta. * * *
    • “Known scientifically as lumateperone, Caplyta is already approved to treat schizophrenia and bipolar depression and could be cleared for major depressive disorder as early as next year. Intra-Cellular licensedthe drug from Bristol Myers Squibb in 2005, just a few years after the company formed and right as big pharma really started backing away from neuroscience and psychiatry. Now, the company has about 530 sales reps and plans to expand again in preparation for the move into major depression.”
    • In the article, BioPharma Dive interviews Sharon Mates, Intra-Cellular’s founder and CEO.
  • Modern Healthcare reports,
    • “Tim Barry, the CEO of VillageMD, has left the company following a rocky few years mired by its failure to help execute on a healthcare push launched by majority-owner Walgreens Boots Alliance.
    • “It’s unclear exactly when Barry left the Chicago-based company, but VillageMD Chief Operations Officer Jim Murray replaced him “effective immediately,” assuming all day-to-day leadership responsibilities, spokeswoman Molly Lynch said in a statement to Crain’s today.
    • “VillageMD reaffirms its commitment to providing high-quality, accessible healthcare services for individuals and communities across the United States,” Lynch said. She declined to provide additional information about the transition.
    • “Barry co-founded VillageMD in 2013 as a primary care company focused on value-based care, growing to hundreds of locations across the country.”

Happy Thanksgiving!

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–

The FEHBlog will be back on Friday.

From Washington, DC,

Transition News

  • Govexec tells us,
    • “President-elect Trump has reached an agreement with the Biden administration that will allow his teams to deploy throughout federal government, ending a standoff that had blocked official presidential transition efforts taking place. 
    • “Transition staff assigned to each agency, known as landing teams or agency review teams, will now physically enter headquarters offices throughout government. Once there, they will meet with assigned career senior executive staff, receive already drafted briefings on agency activities and begin the process of exchanging information about existing projects and future priorities.”
  • STAT News reports,
    • “President-elect Trump has chosen Stanford University professor Jay Bhattacharya to lead the National Institutes of Health, his transition announced Tuesday.
    • “If confirmed by the Senate, Bhattacharya would be in charge of implementing the incoming Trump administration’s bold goals to reform the agency. 
  • The Wall Street Journal adds,
    • “Bhattacharya is both a doctor and economist who became known during the Covid-19 pandemic as a co-author of the Great Barrington Declaration, a document that called for ending lockdowns and isolating the vulnerable so that young, healthy people could get infected and build up immunity in the population. 
    • “Other doctors and public-health researchers, including then-infectious disease chief Dr. Anthony Fauci, criticized the document and said its approach was flawed and would lead to unnecessary deaths.”
  • The Hill notes,
    • “President-elect Trump’s choice for deputy secretary of Health and Human Services is Jim O’Neill, an investor and historically close associate of billionaire Peter Thiel, the president-elect said Tuesday.”

Medicare / GLP-1 Drug News

  • The American Hospital Association News informs us,
    • “The Department of Health and Human Services Nov. 26 issued a final rule that expands access to kidney and liver transplants for individuals with HIV by removing clinical research requirements. Specifically, the rule implements a stipulation under the HIV Organ Policy Equity Act, eliminating the need for approval from the clinical research and institutional review board for kidney and liver transplants between donors with HIV and recipients with HIV. The change was based on research showing the safety and effectiveness of such transplants, HHS said. The final rule is effective Nov. 27.
    • “In tandem with the final rule, the National Institutes of Health published a notice seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung and pancreas, with a 15-day comment period.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 26 proposed changes to the Medicare Advantage and prescription drug programs for contract year 2026. Those changes would permit coverage of anti-obesity medications in the Medicare and Medicaid programs; fortify existing limitations on insurer use of internal coverage criteria and requirements for MA plans to provide coverage for all reasonable and necessary Medicare Part A and B benefits; and apply additional guardrails to insurer use of artificial intelligence to ensure it does not result in inequitable treatment or access to care. CMS also proposes to update MA and Part D plan medical loss ratio reporting requirements to improve oversight, align reporting with commercial and Medicaid reporting, and request additional information on MLR and vertical integration. 
    • “Among other provisions, the proposed rule would require MA plans to make provider directory information more widely available through the Medicare Plan Finder tool; limit enrollee cost sharing for behavioral health services to an amount that is no greater than Traditional Medicare; enhance CMS oversight of MA agent and broker marketing and communication materials; increase insurer reporting requirements related to insurer use of prior authorization and potential health equity implications; and add new requirements governing MA plan use of debit cards to administer enrollee supplemental benefits. Finally, the proposed rule would also codify several provisions in the Inflation Reduction Act, such as capping certain out-of-pocket costs in Medicare Part D, and other pharmacy-related provisions, such as new requirements for Part D sponsors on formulary inclusion and placement of generic drugs and biosimilars.” 
  • Here is a link to the CMS fact sheet about the Medicare Advantage and Part D proposed changes for 2026.
  • KFF already has issued a policy watch about CMS’s proposal to cover GLP-1 drugs for obesity under Medicare Part D and Medicaid beginning in 2026. The FEHBlog is surprised that CMS made this decision knowing that the Inflation Reduction Act has placed financial pressure on standalone Medicare Part D plans.
  • The Wall Street Journal notes,
    • The [GLP-1 drug] proposal, which would have to be finalized by the Trump administration, faces uncertain prospects.
  • In this regard, Beckers Hospital Review shares the recent comments of President-elect Trump’s nominee for HHS Secretary Robert F. Kennedy, Jr., concerning GLP-1 drugs.
  • The Wall Street Journal adds,
    • “Meantime, Mehmet Oz, the choice to run the Centers for Medicare and Medicaid Services, has said on X that the drugs “can be a big help. We need to make it as easy as possible for people to meet their health goals, period.” * * *
  • On a related note, MedCity News discusses “The Promise and Challenge of GLP-1 Medications: Ensuring ROI in Obesity Care.”

Federal Employment Tidbits

  • Federal News Network reports
    • “Federal Executive Boards are looking to expand their offerings to even more federal employees working outside of the Washington, D.C., region.
    • “After reporting successful training sessions, recruitment events and cost savings in the last fiscal year, the Office of Personnel Management sees an opportunity to extend FEBs’ reach to more than double the number of feds who can access the program’s resources.
    • “The expansion would now be possible, after the FEB program went a restructuring, as well as recently developing a new funding model, OPM said.
    • “This transformation is designed to enhance the FEBs’ effectiveness in fostering interagency collaboration, better serve the 85% of federal employees located outside Washington, D.C., and expand FEBs’ reach to areas with significant federal activity but no FEB presence,” OPM wrote in its fiscal 2023 FEB annual report, published earlier this month.”
  • FedWeek lets us know,
    • “Availability of telework has had a positive impact on recruitment and retention, a sampling of four agencies told GAO, but its effect on customer service and other agency operations is hard to gauge—and three of the four have done little to even try.
    • “The effect on productivity has become a major focus in the ongoing debate over agency telework levels that, although well below the peak of the pandemic period, remain high by historic measures. The GAO report, while not conclusive, adds information to a debate that may result in moves to restrict telework starting in January by the new Congress, the Trump administration, or both.”

FDA News

  • Per Fierce Pharma,
    • “In 2001, a Time Magazine cover story touted Novartis’ targeted leukemia treatment Gleevec (imatinib) as a new kind of “ammunition in the war against cancer.” Along with a picture of the Gleevec pills, Time exclaimed: “These are the bullets.”
    • “Twenty-three years later, patients no longer need to take a “bullet” to reap the benefits of imatinib as Shorla Oncology has scored an FDA approval for its strawberry-flavored drink version of the treatment. Dubbed Imkeldi, it becomes the first oral liquid form of imatinib, Shorla said in a press release.
    • “The therapy can help patients combat myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), gastrointestinal tumors (GIST) and cancers such as chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).”
  • Per MedTech Dive,
    • “Zimmer Biomet said Monday that it received approval for a cementless partial knee replacement implant in the U.S.
    • “The Oxford Cementless Partial Knee launched in England in 2004. The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S. The orthopedic company plans to launch the implant in the first quarter of 2025.
    • “Zimmer has identified the device as a good fit for ambulatory surgical centers (ASC) and CEO Ivan Tornos has forecast the product will be one of the top three knee growth drivers in the U.S.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “A highly anticipated obesity-drug candidate from biotech Amgen helped patients shed a significant amount of weight in a mid-stage study but fell short of the loftier expectations of some investors. 
    • “Subjects taking Amgen’s MariTide lost 20% of their body weight compared with those who received placebos, Amgen said Tuesday. Analysts had generally expected the drug to achieve weight reduction of 20% or more.
    • “About 11% of subjects dropped out of the study because of side effects, the most common of which included nausea and vomiting.”
  • BioPharma Dive offers a tracker for obesity drug trials.
  • Beckers Hospital Review relates,
    • “A new study on asthma medication Singulair has raised concerns about its potential mental health side effects, USA Today reported Nov. 24. 
    • “The study, presented by the FDA at the American College of Toxicology meeting in Austin, Texas, found that the drug binds to multiple brain receptors linked to mood, cognition, sleep and impulse control. While the research does not confirm if this binding causes harmful side effects, experts warned it could be a significant concern. 
    • “Singulair, commonly prescribed for asthma and allergy symptoms, has been linked to severe neuropsychiatric issues, including anxiety, depression, hallucinations, irritability and suicidal thoughts, USA Today reported.
    • ‘In 2020, the FDA added a boxed warning to the drug, highlighting the risk of severe mental health side effects. Since its introduction in 1998, Singulair has been associated with dozens of suicides and other psychiatric disorders, with reports of adverse effects continuing into recent years. 
    • “Despite the new findings, the FDA said it will not immediately update the drug’s label. The agency also emphasized that more research is needed to fully understand the extent of the drug’s impact on the brain, according to the report.”
  • The National Institutes of Health shares news about “Sleep and heart healing | Liver-brain communication | Characterizing sensory nerves.”
  • Beckers Hospital Review offers a “‘straight-A’ hospital’s safety playbook.”

From the U.S. healthcare business front,

  • Fierce Healthcare points out,
    • “Pittsburgh-based health insurer and provider Highmark Health has brought in $529 million in net income through the first three quarters of the year, according to its latest financial details released Tuesday.
    • “That’s on $22.1 billion in revenue through the first nine months of 2024, along with $273 million in operating gain.
    • “Highmark said that its financial performance is driven by its health plans along with increased volumes at its Allegheny Health Network (AHN). As of Sept. 30, the AHN saw a 3% increase in inpatient discharges and observations as well as 7% more outpatient registrations compared to the same time last year.
    • “In addition, the AHN logged a 5% increase in physician visits and a 6% increase in visits to the emergency room.”
  • Modern Healthcare reports,
    • “Community Health Systems scrapped a $120 million deal to sell three Pennsylvania hospitals and related facilities to WoodBridge Healthcare.
    • “CHS and WoodBridge mutually decided to dissolve the agreement Friday due to WoodBridge’s inability to satisfy funding requirements, according to a Tuesday news release. Investment banking firm Zeigler was unable to sell the bonds needed to fund the acquisition, despite earlier indications of confidence in the bond sales, WoodBridge said in a separate release.”
  • Chief Healthcare Executive (11/22, Southwick) reported, “The majority of hospital and health care facility reviews on Yelp are negative, according to a new study.” Investigators found that “in March 2020, 54.3% of reviews on Yelp were positive, but that number has dropped to 47.9%” Chief Healthcare Executive adds, “Since the second half of 2021, positive reviews haven’t surpassed 50%.” The research was published in JAMA Network Open. Thanks, Covid.

Weekend Update

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The House of Representatives and the Senate are on District / State work breaks from Capitol Hill this week due to the Thanksgiving holiday.
  • The Hill offers backgrounds on the Food and Drug Administration commissioner, Centers for Disease Control director, and Surgeon General nominees that President-elect Trump announced Friday evening.
  • STAT News reports
    • “A conservative federal judge in Texas has ruled in favor of UnitedHealth Group, saying the federal government unlawfully factored in a “disputed” phone call to lower UnitedHealth’s Medicare Advantage ratings. 
    • “The Centers for Medicare and Medicaid Services will now have to revise UnitedHealth’s 2025 Medicare Advantage ratings by taking out the call center metric, and “immediately publish the recalculated star ratings in the Medicare Plan Finder,” Judge Jeremy Kernodle wrote in his ruling.”
    • Congrats UHG.
    • “Four other large Medicare Advantage insurers — Humana, Elevance Health, Centene, and Blue Cross Blue Shield of Louisiana — have also sued Medicare for downgrading their 2025-star ratings. The lawsuits from Humana and Centene similarly involve the government’s evaluation of their call centers.”
  • Federal News Network tells us,
    • “The Office of Personnel Management has a new leader to focus specifically on federal employees working in HR. Jeff Bardwell will be the first-ever senior executive to serve as the advisor for human resources workforce programs at OPM. In the new position, Bardwell will be tasked with developing and managing the direction of the HR workforce governmentwide. His work will likely include defining HR career paths and improving HR training and professional development opportunities. Bardwell previously spent 15 years working at the Department of Homeland Security.”

From the public health and medical research front,

  • The New York Times discusses how healthcare can unnecessarily take time away from senior citizens.
    • “[S]lowing the health care treadmill — an approach Dr. Montori has called “minimally disruptive medicine” — is possible.
    • “If doctors and clinics and health care systems paid attention to ways to lessen the burden, we’d all be better off,” Dr. Ganguli said. “And some are fairly simple.”
    • “One strategy: reducing what experts call “low-value care.” Her research has confirmed what critics have pointed out for years: Older people receive too many services of dubious worth, including prostate cancer screening in men over 70 and unneeded tests before surgery.”
  • Fortune Well shares “Tips and habits for getting a good night’s rest and boosting your health.”
  • The Wall Street Journal offers an obituary for “Janelle Goetcheus, the ‘Mother Teresa of Washington, D.C.,’ dies at 84. She felt a pull to practice medicine and a call to serve God—the two were always intertwined.
    • “Goetcheus [and her husband, a Methodist minister] spent the [last] half-century treating the unhoused in Washington, D.C. She helped open clinics, organizations and warm buildings to support and care for them. She also visited patients on park benches and in the street—treating people where they are was central to her mission.
    • “Sometimes called the “Mother Teresa of Washington, D.C.,” Goetcheus was best known for co-founding Christ House with a group that included her husband, the Rev. Allen Goetcheus. A “medical respite,” Christ House is a place where men who are no longer sick enough to be in a hospital, but don’t have an appropriate place to convalesce, can live while they recover. It was also the home where the couple raised their three children and where she died, Oct. 26, at the age of 84.” * * *
    • “We wanted to learn to be with people and not just to do for people,” Goetcheus said in the oral-history interview.”
    • RIP Dr. Goetcheus.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “A growing number of companies have begun to offer employees access to menopause-related benefits in their health insurance, including paid time off, access to health providers knowledgeable about menopause, coverage of medication for menopause symptoms, and even altered work schedules and relaxed dress code options. These benefits are meant to help employees cope with symptoms such as hot flashes, depression and other physical discomforts.
    • “The benefits are designed to meet the needs of people dealing with menopause and of their employers, who are adding such coverage to help retain employees, many who have decades of experience, are in management and senior leadership positions or are in line for those posts.
    • “Among the companies offering a variety of menopause-related benefits are Microsoft, Genentech, Adobe and insurer Healthfirst.”
  • BioPharma Dive reports,
    • “The Food and Drug Administration has approved a new medicine for a deadly genetic heart condition, boosting its developer, BridgeBio Pharma, and teeing up a battle for control of a lucrative market targeted by several drugmakers.
    • “The agency on Friday cleared Attruby, known scientifically as acoramidis, for people with a cardiac form of transthyretin amyloidosis, a progressive disease that leads to heart failure and death.
    • “In testing, Attruby helped keep people alive and out of the hospital longer than those who’d received a placebo. Treatment was also associated with improvements in quality of life as well as markers of heart health.
    • “Notably, the drug is approved to prevent hospitalization or death resulting from heart complications of transthyretin amyloidosis with cardiomyopathy. Investors had been skeptical BridgeBio would earn such a distinction from regulators, leading to doubts about Attruby’scommercial prospects. 
    • “BridgeBio priced Attruby at just under $19,000 for a 28-day supply, translating to an annual list cost of about $244,000.”
  • McKinsey & Company considers what’s next for AI and healthcare.
    • In healthcare—with patient well-being and lives at stake—the advancement of AI seems particularly momentous. In an industry battling staffing shortages and increasing costs, health system leaders need to consider all possible solutions, including AI technologies. “Organizations are eager to use generative AI to help enhance how healthcare stakeholders work and operate,” write McKinsey’s Jessica Lamb and coauthors, “but some are still adopting a wait-and-see approach.” Where do you stand? Explore these insights to get up to date on AI and healthcare topics including: 
      • Adding artificial intelligence to nurses’ toolbox
      • Making coverage and cost information more understandable
      • AI impact on the payment integrity (PI) value chain
      • AI use cases in claims processing, enrollment, and underwriting.
  • HR Dive provides “a roundup of numbers from the last week of HR news — including the percentage of employers covering GLP-1s for obesity treatment [44%].”

Thursday Miscellany

David Ermer–CDC, CMS, FDA, Generative AI, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “President-elect Donald Trump said he would nominate environmental lawyer and vaccine skeptic Robert F. Kennedy Jr. to serve as health and human services secretary, putting a noted critic of U.S. public policy atop the country’s vast health bureaucracy. 
    • “Kennedy has promised sweeping changes to food-and-drug regulation and government-funded scientific research, in recent days saying the Food and Drug Administration’s nutrition department needed to be eliminated and warning the agency’s employees to “pack your bags.”
    • “Kennedy, 70 years old, abandoned his independent presidential bid in August and endorsed Trump, promising that he and the Republican would work to “make America healthy again.”
    • “Kennedy said on social media after his nomination that “we have a generational opportunity to bring together the greatest minds in science, medicine, industry, and government to put an end to the chronic disease epidemic.”
  • Per an HHS press release,
    • “Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced a new nationwide campaign to raise public awareness of the National Maternal Mental Health Hotline (1-833-TLC-MAMA). The National Maternal Mental Health Hotline is a cornerstone of the Biden-Harris Administration’s broader efforts to improve maternal health and supports HRSA’s ongoing initiative to reduce maternal mortality and health disparities. While mental health conditions are the leading cause of pregnancy-related deaths, more than 80 percent of pregnancy-related deaths are preventable according to the Centers for Disease Control and Prevention (CDC).
    • “As part of the campaign, HHS will collaborate with companies and organizations such as retailers, grocers, pharmacies, and health and community associations to publicize mental health resources for moms and pregnant women in everyday locations. The first six Maternal Mental Health Champions announced today have thousands of locations and a broad presence in all 50 states, Washington, D.C., Puerto Rico, and the U.S. Virgin Islands. HRSA Deputy Administrator Jordan Grossman announced this campaign in conjunction with HRSA’s latest state Enhancing Maternal Health Initiative convening in Portland, Oregon.” * * *
    • “The National Maternal Mental Health Hotline is a safe space for pregnant women and new moms to get the emotional and mental health support they need, and we want to continue to reach even more pregnant women, new moms, and their loved ones with this vital support,” said HRSA Administrator Carole Johnson. “That’s why we are excited to partner with grocery stores, pharmacies, and other organizations to help get the word out about this important resource for in communities across the country.” * * *
    • “For more information on the National Maternal Mental Health Hotline and to download new promotional materials, visit: https://mchb.hrsa.gov/national-maternal-mental-health-hotline.”
  • Healthcare Dive lets us know,
    • “The Biden administration is moving to lessen the importance of a controversial metric used to calculate valuable Medicare Advantage star ratings that’s been at the center of recent lawsuits.
    • “UnitedHealthcare, Centene and Humana have all sued the government this fall for downgrading their quality scores based on assessments of their customer support centers. Payers argued the measure had an outsized impact on final star ratings, and it now seems regulators might agree.
    • “We have already put in place that [the call center metric] is going to have a smaller weighting on star ratings moving forward,” CMS Medicare Director Meena Seshamani said Wednesday at the Milken Institute’s Future of Health Summit in Washington, D.C.”
  • Federal News Network interviews OPM Director Rob Shriver about the Federal Employee Benefits Open Season.
  • Tammy Flanagan, writing in Govexec, identifies federal and postal employee “retirement decisions that require careful consideration since they cannot be changed.”
  • Federal News Network tells us,
    • “The Postal Service is reporting a deeper financial loss than it’s seen in recent years and is calling on Congress and the incoming Trump administration to address rising costs that are beyond its control.  
    • “USPS reported a $9.5 billion net loss for fiscal 2024, despite year-over-year growth in revenue and a reduction in its controllable expenses. The agency saw a $6.5 billion loss in FY 2023. 
    • “USPS officials said 80% of the agency’s losses come from fixed costs — including pension contributions for its retirees and workers’ compensation claims for employees injured on the job.  
    • “The agency will not seek to raise mail prices in January 2025, but it plans to keep setting higher prices each July and January after that, through the end of 2027.
    • “USPS projections show the agency will end FY 2025 with a $6.9 billion net loss for FY 2025 and is falling short of its “break-even” goal under a 10-year reform plan.” 

From the public health and medical research front,

  • STAT News reports,
    • “A Canadian teenager who is in critical condition after contracting H5N1 bird flu was infected with a version of the virus that is different from the one circulating in dairy cattle in the United States, Canadian authorities announced Wednesday.
    • “The National Microbiology Laboratory in Winnipeg confirmed the infection was indeed caused by the H5N1 virus. But genetic sequencing showed that it is of a genotype that has been found in wild birds, not the version that has been circulating in dairy cattle in the U.S. 
    • “Canada has been doing surveillance in dairy cows looking for the virus, but to date has not detected it in any herds.
    • “Bonnie Henry, British Columbia’s provincial health officer, told STAT in an interview that she’d been expecting these genetic sequencing results. “That’s what we’ve been seeing consistently,” she said.”
  • HCPLive informs us,
    • “Initiation of population-wide screening for chronic kidney disease (CKD) followed by treatment with conventional CKD therapy combined with sodium-glucose cotransporter-2 (SGLT2) inhibitors would be cost-effective for US adults when initiated at 55 years of age, according to findings from a recent study.
    • “Results showed screening every 5 years combined with SGLT2 inhibitors from 55-75 years of age would cost $128,400 per quality-adjusted life year (QALY) gained. While initiation of screening at 35 or 45 years of age produced larger population health benefits, these strategies incurred additional costs totaling> $200,000 per QALY gained.
    • “In the absence of effective CKD treatment options at the time, in 2012, the US Preventive Services Task Force found insufficient evidence to show screening and early detection of CKD improved clinical outcomes. However, the recent emergence of SGLT2 inhibitors as a practice-changing therapy for CKD has prompted clinical guideline organizations to update standard of care recommendations for CKD to include these medications.”
  • Per BioPharma Dive,
    • “PTC Therapeutics on Wednesday won Food and Drug Administration approval for Kebilidi, the first gene therapy cleared in the U.S. for direct administration to the brain.
    • “The treatment is designed for patients with aromatic L-amino acid decarboxylase, or AADC, deficiency, a condition that affects the way neurons transmit information to other cells. The potentially fatal disorder typically manifests in the first six months after babies are born and affects all aspects of their lives, both physical and mental.
    • “Kebilidi is designed to deliver a functioning DDC gene into the body, correcting the genetic defect that causes the disorder. It’s administered by a neurosurgeon in four infusions in one session.”
  • Healthcare Dive relates,
    • “Increased telehealth utilization wasn’t linked to more low-value services at primary care clinics, according to a study published this week in JAMA Network Open.
    • “The research found no association between practices that used high levels of telehealth and most types of low-value care, or services that have no clinical benefit for patients and rack up costs.
    • “The findings could reassure policymakers who have raised concerns that virtual care could increase unnecessary or wasteful services and drive-up healthcare spending, the study’s authors wrote.” 
  • The Wall Street Journal reports,
    • “Intermittent fasting probably isn’t the health hack you hoped it would be.
    • “More studies suggest the tactic can help you lose weight, but likely isn’t a silver bullet for other health improvements like lowering your inflammation levels or lengthening your lifespan. And some evidence suggests fasting can make it harder to build and retain muscle.
    • “People were hoping it was this magical thing that did amazing things for them,” says Krista Varady, a professor of nutrition at the University of Illinois Chicago who has been studying intermittent fasting for 20 years. “All it does is help people eat less.”

From the U.S. healthcare business front,

  • AHIP lets us know,
    • “With more than half of Americans – approximately 180 million people – receiving health care coverage through work, a new nationwide poll finds that a strong majority are satisfied with their current employer-provided plans (75%) and prefer to get their coverage through an employer rather than through the federal or state government (74%).
    • “The poll found that Americans’ satisfaction with employer-provided coverage is driven by the comprehensive coverage (49%), affordability (48%) and choice of providers (45%) their plans provide.” * * *
    • “The national survey of 1,000 people with employer-provided coverage was conducted online from July 10-19, 2024, with a margin of error of +/- 3%. 
      • “Click here to view the infographic.
      • “Click here to view the survey results.
      • “Click here to view a slide presentation of the survey results.”
  • Fierce Healthcare reports about the second day of its Fierce Health Payer Summit.
  • The FEHBlog took sometime today listening to the HCPLAN Summit, which was held in Baltimore. At the Summit, HCPLAN released the 2024 results of its Alternative Payment Models survey.
  • Adam Fein, writing in his Drug Channels blog, points out,
    • “Uh oh. As I predicted, the stand-alone Medicare Part D prescription drug plans (PDP) market is vanishing.
    • “For 2025, DCI’s exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals that the number of PDPs will drop to a historic low. What’s more, the share of plans with a preferred cost sharing pharmacy network will fall to its lowest rate in more than 10 years. Check out the distressing charts below and our review of the remaining national players (Aetna, Cigna, Humana, UnitedHealthcare, and WellCare). 
    • “The destruction of the Part D market marks yet another unintended consequence of the Inflation Reduction Act of 2022 (IRA). The IRA makes PDPs less economically viable and will drive even more seniors into Medicare Advantage Prescription Drug (MA-PD) plans—despite the challenges facing those plans. The 2025 decline will occur even after CMS gifted $7 billion to PDPs to prevent a complete collapse of the 2025 market. 
    • “Legislate in haste. Repent in leisure.”
  • STAT News reports,
    • “In a move to safeguard the company’s dominant position in cancer, Merck said Thursday it will license a new cancer drug from LaNova Medicines, a Shanghai-based firm, for $588 million upfront and as much as $2.7 billion in potential milestone payments.
    • “The cancer immunotherapy Keytruda, Merck’s most important product and the best-selling drug in the world with $23 billion in annual sales, is set to lose patent protection and face competition from generic drugmakers as early as 2028, and investors are already fretting about what will happen at Merck when revenues from the medicine begin to decline.”
  • Healthcare Dive lets us know,
    • “A group of health systems, led by Boston-based Mass General Brigham, is hoping to solve that problem. 
    • “On Wednesday, the academic medical center launched the Healthcare AI Challenge Collaborative, which will allow participating clinicians to test the latest AI offerings in simulated clinical settings. Clinicians will pit models against each other in head-to-head competition and produce public rankings of the commercial tools by the end of the year.
    • “Participating health systems say that the chance to directly compare AI products is overdue.”
  • Per Fierce Healthcare,
    • “Blue Cross Blue Shield of Massachusetts members will benefit from an expanded partnership with Maven Clinic, a new doula pilot program and more caregiving support in collaboration with Cleo, the company announced Nov. 13.
    • “Its doula program, called Accompany Doula Care, connects “racially and ethnically diverse” members with a trained doula. The pilot will collect data to assess whether the program is adequately reaching members through the birthing timeline, including prenatal visits, in-person support during childbirth and postpartum visits.
    • “Black women experience higher levels of maternal morbidity, Blue Cross’ health equity report found.
    • “Eligible Blues members will also have access to Maven Clinic’s Menopause and Midlife Health program. This program can be utilized as a buy-up for self-insured accounts, a news release explains.”
  • and
    • “Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men’s hair loss and anti-aging skin care.
    • “The new service builds on Amazon One Medical’s existing Pay-per-visit telehealth service that offers healthcare for more than 30 common conditions.
    • “The new service offers a subscription plan with low, upfront monthly pricing for a clinical visit, treatment plan, and free medication delivery. The service initially focuses on five conditions: anti-aging skin care treatment, men’s hair loss, erectile dysfunction, eyelash growth, and motion sickness.
    • “Through this service, Prime members can get anti-aging skin care treatment from $10/month; men’s hair loss solutions from $16/month; ED treatment from $19/month; eyelash growth solutions from $43/month; and treatment for motion sickness from $2/use—using Prime Rx at checkout, the company said in a blog post Thursday.”

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Washington Post reports,
    • “Republican lawmakers returned to Capitol Hill on Tuesday with some spring in their step.
    • After winning the presidency and the Senate majority, the party is on the cusp of regaining the House majority — and with it, a powerful governing trifecta in Washington.
    • “Though control of the House may not be called for days, GOP lawmakers will this week work on the assumption they’ve clinched it, pushing ahead with House leadership elections and shaping plans to reverse or overhaul much of the Biden administration’s domestic and foreign policy.
    • “Though control of the House may not be called for days, GOP lawmakers will this week work on the assumption they’ve clinched it, pushing ahead with House leadership elections and shaping plans to reverse or overhaul much of the Biden administration’s domestic and foreign policy.”
  • The Post must be tracking the AP results (214 – 206) because Decision Desk HQ has decided that the Republicans do have a majority of seats in the House (219 – 210, 218 being a majority).
  • The Wall Street Journal reports,
    • “President-elect Donald Trump picked Tesla CEO Elon Musk and biotech company founder Vivek Ramaswamy, a former Republican presidential candidate, to lead an effort to cut spending, eliminate regulations and restructure federal agencies.
    • “Trump said in a statement Tuesday night that Ramaswamy and Musk—the wealthiest person in the world, who oversees six companies including Tesla—would lead what the president-elect called the Department of Government Efficiency, or DOGE. The department’s mandate is to streamline government bureaucracy, the president-elect said.
    • “DOGE will operate outside of the federal government, Trump said, and will work with the White House Office of Management and Budget to implement its recommendations.” 
  • The American Hospital Association News lets us know,
    • “In comments Nov. 12 to majority and minority leaders of the House and Senate, the AHA requested that Congress act on key priorities for hospitals and health systems before the end of 2024. AHA urged Congress to continue providing relief from Medicaid Disproportionate Share Hospital Payment cuts; continue the Medicare-dependent Hospitals and Low-volume Adjustment programs that expire Dec. 31; reject site-neutral payment proposals; and pass the Improving Seniors’ Timely Access to Care Act (H.R. 8702/ S. 4532), legislation that would reduce the wide variation in prior authorization methods in the Medicare Advantage program.” * * * 
    • “AHA also urged Congress to extend the hospital-at-home waiver for five years through 2029; mitigate scheduled physician reimbursement cuts for 2025; and pass the Safety from Violence for Healthcare Employees Act (H.R. 2584/S. 2768), legislation that would provide federal protections from workplace violence for hospital workers, similar to protections for airport and airline workers.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 12 released a report evaluating past and present approaches to rural health. It shares how previous CMS Innovation Center models focusing on rural health have been applied to recent model development. 
    • “The report also shares themes, concepts and next steps gathered from its rural health “Hackathon,” a series of events across the U.S. that brought experts together to brainstorm solutions to rural health challenges. The top themes highlighted a need for training, regulatory changes and collaboration to help improve access to care and support transformation. The report also outlines possible considerations for future Accountable Care Organization-focused and other models.
    • “CMS’ next intention is to issue a request for application to fill the 10 open spaces for its Rural Community Hospital Demonstration. The program was directed by Congress and requires a test of cost-based payment for Medicare inpatient services for rural hospitals with fewer than 51 beds that are ineligible for critical access hospital status.”
  • OPM issued a press release today about the ongoing Open Season while Govexec informs us,
    • “Retired and active federal employees find selecting a health care plan to be more confusing than creating a will, reading Shakespeare, learning a new language or navigating a divorce, according to a new survey from the National Active and Retired Federal Employees Association. 
    • “While the process may be complex, NARFE is urging current and former federal and postal employees to look at their options for health care insurance carriers and coverage plans during this year’s open season, which lasts from Nov. 11 through Dec. 9, especially in light of premium price increases next year that will be the largest in recent memory. 
    • “John Hatton, NARFE’s staff vice president of policy and programs, told Government Executive that enrollees could be missing out on thousands of dollars in savings. 
    • “We always recommend people to take a look at their options during open season to make sure they have the coverage that they need so they’re not paying more in out-of-pocket expenses later, but also to pay less in premiums if they don’t need the coverage that they currently have,” he said. 
    • “More than half of active federal employees (57%) and retired ones (55%) in NARFE’s survey annually review their health insurance options. For this year’s open season, 60% of current feds responded that they are planning on participating compared to 47% of retirees.” 
  • RAND shares survey results about U.S. veterans’ families, which should be of interest to FEHB carriers as the federal government wisely hire a lot of veterans.
  • Meanwhile, AHIP fact checks a Wall Street Journal article criticizing the Medicare Advantage program.
  • The New York Times reports,
    • “The Justice Department and four Democratic state attorneys general on Tuesday filed an antitrust lawsuit against the giant UnitedHealth Group in an attempt to block its $3.3 billion deal to take over Amedisys, a large home health company.
    • “Unless this $3.3 billion transaction is stopped, UnitedHealth Group will further extend its grip to home health and hospice care, threatening seniors, their families and nurses,” Jonathan Kanter, the assistant attorney general who heads the department’s antitrust division, said in a statement on Tuesday.“
  • The Wall Street Journal adds,
    • “Johnson & Johnson launched a legal challenge against a federal health agency blocking the company’s quest to tighten the way it provides lucrative drug discounts to hospitals.
    • “J&J filed a lawsuit in federal court in Washington on Tuesday against the heads of the U.S. Department of Health and Human Services and one of its agencies, seeking a court ruling that says J&J’s plan is legal and to prevent the agency from rejecting it.
    • “The lawsuit escalates the pharmaceutical industry’s fight to rein in the federal drug-discount program known as 340B. The program, created in 1992, requires drugmakers to provide steep discounts on outpatient drugs to hospitals and clinics that serve uninsured and low-income patients. 
    • “The pharmaceutical industry has argued that the 340B program has strayed from its original purpose of helping safety-net hospitals. Manufacturers say they sell medicines to covered hospitals at steep discounts, but some large hospitals mark up the prices charged to both uninsured patients and insurers.”

From the public health and medical research front,

  • The New York Times reports,
    • “After decades of unrelenting increases, rates of sexually transmitted infections in the United States are showing hints of a downturn.
    • “Diagnoses of gonorrhea dipped in nearly all age groups last year, compared with 2022, and new cases of syphilis and chlamydia remained about the same, according to data released on Tuesday by the Centers for Disease Control and Prevention.
    • “The results are not yet cause for celebration.
    • “Overall, more than 2.4 million new S.T.I.s were diagnosed last year, about a million more than the figure 20 years ago. Nearly 4,000 babies were diagnosed with congenital syphilis last year, and 279 of them were stillborn or died soon after.
    • “Still, experts said they were cautiously optimistic that a resurgent tide of infections was beginning to turn.”
  • Per a National Institutes of Health press release,
    • “Researchers at the National Institutes of Health (NIH) and their collaborators have discovered a new way in which RAS genes, which are commonly mutated in cancer, may drive tumor growth beyond their well-known role in signaling at the cell surface. Mutant RAS, they found, helps to kick off a series of events involving the transport of specific nuclear proteins that lead to uncontrolled tumor growth, according to a study published Nov. 11, 2024, in Nature Cancer.
    • “RAS genes are the second most frequently mutated genes in cancer, and mutant RAS proteins are key drivers of some of the deadliest cancers, including nearly all pancreatic cancers, half of colorectal cancers, and one-third of lung cancers. Decades of research have shown that mutant RAS proteins promote the development and growth of tumors by activating specific proteins at the cell surface, creating a constant stream of signals telling cells to grow.” * * *
    • “The study also found evidence that mutant RAS proteins perform this same function in other cancer types, suggesting that this mechanism may be a general feature of cancers with mutated RAS genes.
    • “The researchers believe their finding may have potential applications for the treatment of RAS-fueled cancers. They have started to look at how this function for RAS works in pancreatic cancer in particular because there are so few effective treatments for this type of cancer.
    • “New treatment combinations could one day be developed that take this new role for RAS into consideration,” Dr. [Douglas] Lowy said.”
  • Health Day tells us,
    • “Lives lost to obesity-related heart disease have nearly tripled over the past twenty years, a new study reports.
    • “Heart disease deaths linked to obesity increased 2.8-fold between 1999 and 2020, according to findings presented today at the American Heart Association’s annual meeting in Chicago.
    • “The increase occurred especially among middle-aged men, Black adults, Midwesterners and rural residents, researchers found.
    • “Obesity is a serious risk factor for ischemic heart disease, and this risk is going up at an alarming rate along with the increasing prevalence of obesity,” lead researcher Dr. Aleenah Mohsin, a post-doctoral research fellow at Brown University in Providence, R.I., said in a news release.” * * *
    • “The National Institute of Health has more on the health risks of obesity.”

From the U.S. healthcare business front,

  • Fierce Healthcare surveys the major payors’ third quarter financial results as the curtain falls on the third quarter announcement season.
  • Kaufmann Hall relates,
    • “Though most indicators were down, hospital performance remained relatively stable overall, according to September data. Both inpatient revenue and average lengths of stay increased.
    • “The recent issue of the National Hospital Flash Report covers these and other key performance metrics.”
  • and
    • “In the third quarter of this year, the median investment/subsidy per physician was $304,312—rising above $300,000 for the first time. Other expense metrics such as the total direct expense per provider FTE and labor as a percentage of total expenses increased.
    • “The Physician Flash Report features the most up-to-date industry trends drawn from the same data physician groups use to track their finances and operations.”
  • Per Modern Healthcare,
    • “Ochsner Health may expand its hospital-at-home program throughout the entire health system after successfully piloting a program in New Orleans, the nonprofit healthcare provider said Tuesday.
    • “Ochsner Health said in a news release the pilot, launched in March at Ochsner Medical Center-New Orleans, prevented either initial hospitalizations or 15-day hospital readmissions for 92% of the patients referred to the program through its emergency department and observation unit.
    • “The New Orleans-based health system offered the service through a partnership with myLaurel, a New York-based company that provides transitional and acute care to frail, elderly patients at home instead of a hospital. Patients received virtual and in-home visits from clinicians, along with lab work, medications, education about treatment plans and other services.”
  • and
    • “Cardinal Health has entered definitive agreements to acquire a majority stake in GI Alliance, a gastroenterology management services organization, and the entirety of Advanced Diabetes Supply Group, a diabetes medical equipment supplier. 
    • “Cardinal expects to acquire Advanced Diabetes Supply for an estimated $1.1 billion and 71% ownership of GI Alliance for an estimated $2.8 billion. Both deals are expected to close by early 2025, pending regulatory approvals.” 
  • STAT News relates
    • “23andMe, the genetics startup that has repeatedly captured the public imagination and then faced nearly fatal business challenges, announced Monday that it would halt its efforts to develop new medicines and lay off 40% of its workforce, focusing instead on selling genetic tests to consumers and using the resulting data for research.
    • “In closing its therapeutics division and laying off 200 people, 23andMe ended an audacious bet it made nearly a decade ago — that it could use the genetic data it had collected not only to assist drug companies but to become one itself.”
  • Per Healthcare Dive,
    • “General Catalyst released new details on its planned acquisition of Akron, Ohio-based Summa Health on Thursday, roughly one year after the venture capital firm said it was looking to buy a health system. 
    • “General Catalyst’s Health Assurance Transformation business, or HATCo, has signed a definitive agreement to purchase Summa for $485 million. The deal, alongside the health system’s current cash on hand, allows Summa to eliminate $850 million in debt — nearly all the debt the health system currently holds, according to Summa’s most recent financial results.
    • “HATCo is also pledging to spend $350 million over the first five years of its ownership to support routine operations and technology investments, plus another $200 million over seven years for “strategic and transformative” initiatives.” 
  • Per MedTech Dive,
    • “Johnson & Johnson said Tuesday it received an investigational device exemption (IDE) from the Food and Drug Administration to start a U.S. clinical trial for its Ottava surgical robot.
    • “The company said it will now prepare U.S. sites to receive Ottava systems, enroll patients and begin surgical cases as it focuses on training clinical trial investigators. J&J’s soft tissue robot will compete with Intuitive Surgical’s da Vinci system, which currently leads the market.
    • “The Ottava platform will incorporate J&J Ethicon surgical instruments designed for the robotic platform, the company said. Ottava will also have a digital system called Polyphonic that will connect surgical technologies, robotics and software, ultimately adding data and insights to support clinical decision making.”
  • and
    • “GE Healthcare has struck a deal to combine its Senographe Pristina mammography system with Radnet’s artificial intelligence-based Smartmammo workflow, the companies said Monday.
    • “The alliance positions GE to distribute Radnet software designed to help mammography centers view images, prioritize cases and support other steps in the workflow. The integration is the first part of a broader collaboration focused on imaging AI.
    • “Radnet CEO Howard Berger told analysts on an earnings call Monday that the mammogram systems “simply need a power source and a connection to the internet,” creating opportunities to image patients in “Walmart and mall locations.”

Happy Veterans Day!

David Ermer–ACA, CDC, Congress, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Megan Lee on Unsplash

Thanks to all those who served our great country.

From Washington, DC,

  • The Washington Post reports,
    • “With Republicans on the cusp of unified control of Washington, Congress appears primed to extend the deadline for a government shutdown well past President-elect Donald Trump’s inauguration.
    • “Lawmakers are discussing a temporary measure that would fund the government into March, according to two people briefed on the discussions, who spoke on the condition of anonymity because they were not authorized to speak publicly.
    • “That would give the Senate plenty of time to begin confirming Trump’s Cabinet nominees, and the House time to plot out maneuvers on tax legislation, without the threat of an imminent government shutdown. Without new legislation, financing for federal agencies will expire Dec. 20.”
  • Modern Health informs us,
    • “A Centers for Disease Control and Prevention report released Friday shows 7.6% of Americans, or 25.3 million people, lacked health insurance during the time of data collection from April to June. Although the rate represents a 0.4 percentage point increase from the year-ago period, it is consistent with 2023’s full-year uninsured rate — a historic annual low.
    • “More people have health insurance coverage than ever before — and the peace of mind that comes with it,” Health and Human Services Department Secretary Xavier Becerra said in a statement Sunday. “That is all thanks to the Affordable Care Act’s expansion of Medicaid and creation of the Marketplace.”
  • The American Hospital Association News tells us,
    • In comments Nov. 11 to the Centers for Medicare & Services on its Notice of Benefit and Payment Parameters for 2026, the AHA expressed support for navigators and other assistance personnel as CMS explores how to expand their responsibilities. Navigators and non-navigator assistance personnel work with hospitals and health systems to help connect consumers to financial assistance resources. 
    • “Navigators are already trusted community resources for navigating health insurance coverage and would be a great asset in helping to reach patients who are otherwise not accessing available financial assistance,” the AHA wrote. “We also encourage navigators and assisters to expand their enrollment counseling to help patients enroll in plans with affordable deductible and cost-sharing requirements based on the patient’s financial resources.”
  • The FEHBlog wishes he knew the objectives of the PSHB navigators and the level of their success in achieving those objectives.

From the public health and medical research front,

  • The Washington Post lets us know,
    • “About 41 percent of U.S. adults with hypertension are unaware they have it, according to a report from the National Center for Health Statistics. Left untreated, high blood pressure can increase the risk for heart disease and stroke.
    • “The American College of Cardiology defines hypertension as having systolic blood pressure of 130 mm Hg or above, or diastolic blood pressure of 80 mm Hg or above.
    • The NCHS data is drawn from a two-year survey, from August 2021 to August 2023, of the U.S. population. The survey sample “is selected through a complex, multistage design,” the NCHS report says. The survey information was collected in stages, including interviews conducted in subjects’ homes and a standardized health examination in a mobile exam site. An average of up to three blood pressure readings were taken.
    • “In adults over age 18, 48 percent of the survey’s 6,084 subjects were found to have hypertension — 60 percent of whom were aware that they had high blood pressure.” 
  • HR Dive relates,
    • “Women’s use of health benefits can influence workplace outcomes such as attendance, retention and productivity, according to a Nov. 6 report from the Integrated Benefit Institute.
    • “For instance, 89% of employed U.S. women said employer benefits positively influence overall workplace satisfaction, and 85% said benefits play a crucial role in attracting and retaining talent.
    • “In particular, benefit use was associated with fewer missed workdays, with the greatest effects seen from mental health benefits, reproductive health services and maternity care.
  • The American Medical Association points out what doctors wish their patients knew about ultra processed foods.
  • Per Healio
    • “Low-level lead poisoning remains prevalent across the United States and globally, warranting screening and identification of those at highest risk, according to a recently published review.
    • “Such poisonings are especially dangerous in children because of their adverse links to cognitive and behavioral development, the researchers pointed out in The New England Journal of Medicine.“
  • Per MedPage Today
    • “Healthy lifestyle choices in midlife may offset genetic risks for dementia, stroke, and late-life depression.
    • “Brain Care Scores measure modifiable risk factors for age-related brain diseases.
    • “Compared with lower Brain Care Scores, higher scores were tied to reduced risk of brain disease in people with genetic predisposition to such diseases.”

From the U.S. healthcare business front,

  • Beckers Payer Issues lets us know,
    • Cigna directly confirmed that it is not pursuing a merger with Humana. 
    • “The Cigna Group remains committed to its established M&A criteria and would only consider acquisitions that are strategically aligned, financially attractive, and have a high probability to close,” the company said in a Nov. 11 news release. 
  • Beckers Hospital Review relates,
    • “Oakland, Calif.-based Kaiser Permanente posted a $608 million operating loss (-2.1% operating margin) in the third quarter of 2024, down from an operating income of $156 million (0.6% operating margin) in the same quarter last year, according to its Nov. 8 financial report.  
    • “Kaiser posted an operating revenue of $29 billion in the three months ended Sept. 30, up from $24.9 billion over the same period in 2023. The system reported operating expenses of $29.6 billion in the third quarter, up from $24.7 billion over the same period last year. 
    • “The system said that it continues to experience “increased medical expenses due to higher-than-expected utilization of services, patient acuity and pharmacy costs.” Kaiser also said that its third-quarter performance also included the “impact of Medicaid and other true-ups of annual contracts that normally occur earlier in the year.”
  • STAT News reports,
    • “AbbVie said Monday that its experimental treatment for schizophrenia failed to significantly help patients in two trials, a blow to the company, which got the drug through its recent $9 billion acquisition of Cerevel Therapeutics.
    • “In Phase 2 studies, patients on different doses of the drug, called emraclidine, did not experience significant improvements on a test called the Positive and Negative Syndrome Scale (PANSS) compared with the placebo group.
    • “While we are disappointed with the results, we are continuing to analyze the data to determine next steps,” Roopal Thakkar, AbbVie’s chief scientific officer, said in a statement.”
  • Per Beckers Payer Issues,
    • “A mobile app offered to individuals covered by Centene’s Medicaid plan in Arizona improved medication adherence, and reduced healthcare visits and costs, according to a study published Oct. 21 in The American Journal of Managed Care.
    • “The study found that using the Wellth app helped Medicaid patients with chronic conditions stick to their medications more consistently and reduced unnecessary healthcare visits, ultimately leading to cost savings. The Wellth app uses financial incentives to encourage people to take their medications as prescribed.
    • “Managed care decision makers should consider these findings when deciding what types of behavioral interventions and supports to offer insurance plan members, particularly those managing chronic conditions, to reduce avoidable healthcare expenses,” the researchers wrote.”

Weekend Update

David Ermer–CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Congress returns from the campaign trail on Tuesday to begin its lame duck session. Here is a link to this week’s Congressional Committee schedule. The continuing resolution funding the federal government expires on December 20, 2024.
  • The Federal Employee Benefits Open Season begins at 12:01 am ET Monday morning.
  • Here is a link to an Open Season advice column written by Ann Werts in FedSmith. Ms. Werts makes an interesting observation:
    • “Once you’ve determined what you’re going to compare in the plans you’re considering, there are a couple of great tools you can use to assist you. [Checkbook’s] guidetohealthplans.org is a 3rd party resource that enters the outline of coverage for every federal health plan each year. For a small subscription fee ($15.95), you can access their website to compare any set of plans. Some agencies pay for their employees to use it, so check first to see if it’s available directly through your agency. If not, you can use the code GUIDE20 to receive a 20% discount. 
    • “OPM also provides an online comparison tool. I find it more challenging to use because the output is a 17-column spreadsheet.” 
  • As Leonardo DaVinci observed, “Simplicity is the ultimate sophistication.” 
  • OPM has created an internet portal for Postal Service Health Benefit Plan enrollees to use to compare plans and select a plan. Every PSHBP enrollee should have received a letter about this process. The OPM website explains
    • “Thank you for your interest in the Postal Service Health Benefits Program!
    • “Open Season begins on November 11. To get coverage, please visit
    • “https://health-benefits.opm.gov. You can also call the PSHB Helpline at 844-451-1261.
    • “If you have technical issues with your Login.gov account, Login.gov operates a 24/7 contact center via phone or website contact form. Please visit login.gov/contact for more information.”
  • For those unfamiliar with login,gov, it’s an identity verification tool that the federal government uses with all Americans, not just PSHBP enrollees, to access IRS and Social Security portals as well as the PSHBP enrollment portal.
  • Here is a link to OPM’s public use files for FEHBP, PSHBP, and FEDVIP.
  • Kiplinger offers a better 2025 Medicare Parts B and D IRMAA chart compared to the ones in Friday’s CMS fact sheets plus more background on IRMAA.

From the public health and medical research front

  • Per Medscape
    • “Roux-en-Y gastric bypass (RYGB) produces maximal weight loss in patients with obesity compared with other surgical procedures and with weight loss drugs, according to a meta-analysis comparing the efficacy and safety of the different treatment options. 
    • “However, tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide-1 receptor agonist (GLP-1 RA), produces comparable weight loss and has a favorable safety profile, reported principal investigator Jena Velji-Ibrahim, MD, MSc, from Prisma Health–Upstate/University of South Carolina School of Medicine in Greenville. 
    • “In addition, there was “no significant difference in percentage total body weight loss between tirzepatide when comparing it to one-anastomosis gastric bypass (OAGB), as well as laparoscopic sleeve gastrectomy,” she said.” 
  • and
    • “Noninvasive surveillance with multitarget stool DNA testing or fecal immunochemical testing (FIT) could potentially match colonoscopy for reducing long-term colorectal cancer (CRC) incidence and mortality. It might also reduce colonoscopies by an estimated 15%-41%.
    • “The greatest reduction would likely be achieved by annual FIT-based surveillance, especially with FIT FOB-Gold at a threshold of at least 32 µg/g feces, according to findings from the Dutch MOCCAS study published in Gastroenterology.
    • “In this cross-sectional observational study, the multitarget DNA test outperformed FIT for detecting advanced precursor lesions, especially serrated polyps. According to long-term-impact mathematical modeling, however, DNA-based surveillance would be more costly than colonoscopy surveillance, whereas FIT would save costs.”

From the U.S. healthcare business front,

  • Altarum recently posted a report on trends in healthcare spending at the U.S. state level, including D.C. from 2019 through 2022.
  • Kaufmann Hall tells us,
    • After hearing reports from health systems about decreasing revenue capture from Medicare Advantage (MA) plans, this graphic dives into some of the trends driving this costly challenge providers are facing. MA plans’ popularity has swelled in recent years as seniors are drawn to the extra benefits and lower out-of-pocket costs. As a result, MA enrollees as a share of total inpatient days roughly doubled across all area types between 2015 and 2022. This trend has likely continued as MA penetration has only grown since 2022. This shift has been tough for providers because most MA plans require prior authorization for certain kinds of care, a burnout-driving and costly administrative demand for providers. Although the number of prior authorizations per MA enrollee has remained stable over recent years, providers are seeing more MA patients, leading to an increased burden. On top of that, the overall prior authorization denial rate jumped to 7.4% in 2022, after hovering around 5.7% for several years prior. These decisions can be overturned, but patients and providers often don’t file appeals, leading to higher rates of uncompensated care and lost revenues for providers. Unfortunately, these higher costs have brought many providers to a breaking point in contract negotiations with MA plans, leading to care disruptions that ultimately hurt patients the most.
  • Bloomberg Law reports,
    • “CVS Pharmacy Inc. and the former president of Cigna Corp.’s Express Scripts asked a federal judge to amend an injunction prohibiting her from joining CVS so that it expires at the same time as her noncompete agreement with Cigna.
    • “CVS notified Amy Bricker on Nov. 6 that it’s terminating her inactive employment status with the company, according to a motion the two filed Thursday in the US District Court for the Eastern District of Missouri. CVS and Bricker argued that fact materially changes the circumstances of the injunction because she “will not, even in the future, perform any active employment duties or responsibilities for CVS.
    • “Bricker’s termination followed a Nov. 6 quarterly earnings call where CVS publicly announced senior leadership changes.
    • “It “obviates any need” for the injunction, CVS and Bricker said, and “has the practical effect of interfering with Ms. Bricker engaging in gainful employment for longer than” the Cigna noncompete, which is set to expire Feb. 3.”

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington, DC,

  • The Hill reports
    • “Control of the House has yet to be determined, as a number of critical races remain too close to call, leaving lawmakers — and voters — waiting to see which party will hold the majority next year.
    • “The sprint to 218 seats, however, is nearing the final stretch, after a handful of additional races were called in the days following election night.
    • “Republicans had secured 216 seats in the lower chamber as of Friday morning, with Democrats trailing at 204 seats, according to Decision Desk HQ. A total of 15 races have not yet been called: Democrats are leading in eight of the contests, while GOP candidates are ahead in the other seven.”
  • CMS finally announced the Medicare Part A and B premiums and cost sharing amounts for 2025 today.
    • Medicare Part A cost sharing
      • “The Medicare Part A inpatient hospital deductible that beneficiaries pay if admitted to the hospital will be $1,676 in 2025, an increase of $44 from $1,632 in 2024. The Part A inpatient hospital deductible covers beneficiaries’ share of costs for the first 60 days of Medicare-covered inpatient hospital care in a benefit period. In 2025, beneficiaries must pay a coinsurance amount of $419 per day for the 61st through 90th day of a hospitalization ($408 in 2024) in a benefit period and $838 per day for lifetime reserve days ($816 in 2024). For beneficiaries in skilled nursing facilities, the daily coinsurance for days 21 through 100 of extended care services in a benefit period will be $209.50 in 2025 ($204.00 in 2024).” 
    • Medicare Part B premiums
      • “The standard monthly premium for Medicare Part B enrollees will be $185.00 for 2025, an increase of $10.30 from $174.70 in 2024. The fact sheets also disclose the Medicare Part B Income-Related Monthly Adjustment Amounts (IRMAA).”
    • Medicare Part B annual deductible
      • “The annual deductible for all Medicare Part B beneficiaries will be $257 in 2025, an increase of $17 from the annual deductible of $240 in 2024.  The increase in the 2025 Part B standard premium and deductible is mainly due to projected price changes and assumed utilization increases that are consistent with historical experience.”
  • Modern Healthcare reports,
    • “Many hospitals are not publishing their prices in accordance with the price transparency law, a federal watchdog’s new report found.
    • “More than a third of the 100 hospitals reviewed by the Health and Human Services Department’s Office of Inspector General did not post machine-readable pricing data files correctly, or at all, as required by the 2021 federal law, according to the report released Friday. Most of the violations were related to disclosing the rates hospitals negotiated with insurers, metadata errors and outdated information. Five hospitals did not post any machine-readable files.
    • “The OIG analyzed data from 30 hospitals that were part of the country’s three largest health systems, and the rest were part of a random sample of 5,504 facilities. Researchers reviewed hospital websites between Jan. 17, 2023, and March 14, 2023.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today.
    • “COVID-19 activity is stable or declining in most areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southern, southeastern, and mid-Atlantic United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniaehave continued to increase in young children in the United States.”
    • “COVID-19
      • Nationally, COVID-19 activity is stable or declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. Across the nation, COVID-19 infections are predicted to decline in some states and grow slowly from a low level in others.
      • “CDC expects that the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.”
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low. However, continuing signs of increased RSV activity have been detected in the southern, southeastern, and mid-Atlantic United States, particularly in young children. Emergency department visits and hospitalization rates are increasing in young children in some areas.
    • “Vaccination
      • RSV, influenza, and COVID-19 vaccines are available to provide protection and play a key role in preventing hospitalizations.
  • MedPage Today adds,
    • “If you missed the early fall pushopens in a new tab or window for flu and COVID-19 vaccines, it’s not too late.
    • “Health officials say it’s important to get vaccinated ahead of the holidays, when respiratory bugs tend to spread with travel and indoor celebrations.
    • “Those viruses haven’t caused much trouble so far this fall. But COVID-19 tends to jump in the winter months, a rise that usually starts around Thanksgiving and peaks in January.
    • “And that coincides with flu season, which tends to start in November or December and peak in January or February.
    • “It takes the body about 2 weeks to build up immunity after either shot — meaning vaccination is needed before these viruses start spreading.”
  • Per Health Day,
    • “It doesn’t take much: Adding just five minutes of exercise to your daily routine lowers your blood pressure and might cut your odds for heart disease, new research shows.
    • “The good news is that whatever your physical ability, it doesn’t take long to have a positive effect on blood pressure,” said study lead author Jo Blodgett, from University College London (UCL). “What’s unique about our exercise variable is that it includes all exercise-like activities, from climbing the stairs to a short cycling errand, many of which can be integrated into daily routines.”
    • “Her team published its findings Nov. 6 in the journal Circulation.”
  • and
    • “Women who take vitamin D supplements during a pregnancy may be giving their kids the legacy of stronger bones, new British research suggests.
    • “Children whose moms took vitamin D supplements when pregnant had stronger, denser bones at the age of 7 compared to the kids of women who didn’t, a study from the University of Southampton shows. 
    • It’s a head start on bone health that might last a lifetime, said lead researcher Dr. Rebecca Moon.
    • “This early intervention represents an important public health strategy. It strengthens children’s bones and reduces the risk of conditions like osteoporosis and fractures in later life,” said Moon, a clinical lecturer in child health at the university.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Value-based care platform Astrana Health has signed a definitive agreement with private equity firm Prospect Medical Holdings to acquire some of its assets for $745 million. 
    • “Pending regulatory approvals, Astrana would acquire Prospect Health Plan, Prospect Medical Groups, Prospect Medical Systems, RightRx and Foothill Regional Medical Center in Tustin, California. 
    • “In October, Astrana Health finalized its acquisition of management services organization Collaborative Health System from health insurer Centene for an undisclosed price. The company’s latest acquisitions are expected to close in mid-2025, according to a Friday news release from Astrana. 
    • “Astrana and Prospect Medical did not immediately respond to requests for comment.” 
  • Beckers Payer Issues ranks large payers by third quarter medical loss ratio.
  • Per Fierce Healthcare,
    • “Quest Diagnostics and Elevance Health are broadening their partnership into four more states with the goal of making it easier for patients to access in-network laboratory services.
    • “Beginning Jan. 1, Quest’s service will be available in-network in four additional states: Colorado, Georgia, Nevada and Virginia. This includes routine lab testing, advanced diagnostics and Quest’s network of pathologists, according to an announcement.
    • ‘Members who need lab services are able to schedule appointments online at one of Quest’s patient service centers as well as access test results and updates through the free myQuest mobile app.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care and Insulet executives this week touted the strong demand they’ve seen for their insulin pumps among people with Type 2 diabetes, tipping that adoption could be even greater than previously believed.
    • “Tandem CEO John Sheridan said on an earnings call Wednesday that adoption of pumps among the roughly 2 million patients with insulin-intensive Type 2 diabetes in the U.S. is about 5%. Sheridan told investors that Tandem sees that figure growing to more than 25% over the next several years. Just a few quarters ago, the company was projecting a 15% longer-term adoption rate.
    • “Interest in insulin pumps among people with Type 2 diabetes has made up a solid chunk of new users, helping to propel Tandem to a record quarter in sales.
    • “More than 30,000 people living in the U.S. with Type 2 use a Tandem pump,” Sheridan said. “If we look at it on a quarterly basis, approximately 5-10% of new customers each quarter have Type 2, which has been a consistent trend throughout the years.”
  • and
    • “Exact Sciences reported third-quarter results that fell short of analyst expectations and cut its guidance for the fourth quarter. The cut, which William Blair analysts called a “shocking guidance update,” contributed to a 23% drop in the diagnostic company’s stock Wednesday.
    • “TD Cowen analysts said in a note to investors that the third quarter was the third time in five years that Exact Sciences, which sells the Cologuard colorectal cancer screening test, has missed revenue expectations. 
    • “Screening and precision oncology sales were each 1% below Wall Street’s consensus expectations, William Blair analysts wrote in a note to investors Tuesday. Exact Sciences is forecasting a bigger shortfall for the fourth quarter, with the company lowering its total revenue guidance by 11%, or around $85 million, from the prior implied range, according to William Blair.”

Midweek Update

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, OPM, U.S. Healthcare–
President Grover Cleveland Photo by Library of Congress on Unsplash

From Washington, DC

  • President Donald Trump was reelected following an intervening term by another President in the fashion originated in the late 1800s by President Grover Cleveland, who was a Democrat.
  • NBC News adds this afternoon,
    • “Republicans will win control of the Senate for the next two years, NBC News projects, though control of the House is still up for grabs.
    • “Senate Republicans ousted Democrats in red states to secure the majority, flipping seats in West Virginia, Montana and Ohio, states that have swung heavily to the GOP. And they held their ground in friendly states like Texas and Florida, assuring them at least 51 seats when the new Congress is sworn in next January.” * * *
    • “The GOP senators are expected to elect a new leader next week as longtime Republican leader Mitch McConnell, R-Ky., is stepping down from the role after a record 18 years. His current deputy, Sen. John Thune, R-S.D., and former deputy, Sen. John Cornyn, R-Texas, are battling to take the job when the new Congress begins.”
  • Congress’s lame duck session begins next Tuesday November 12, and it will be a busy time for the legislators. You will recall that on September 26, President Biden signed into law,
    • “H.R. 9747, the “Continuing Appropriations and Extensions Act, 2025,” which provides fiscal year 2025 appropriations to Federal agencies through December 20, 2024, for continuing projects and activities of the Federal Government.” 
  • Govexec discusses FEHB plan fertility benefit offerings for 2025.
  • WTW Consulting shares advice on how to effectively use healthcare and dependent care FSAs.
  • Per MedTech Dive,
    • “Advamed has asked for Medicare to cover supplemental imaging of patients with heterogeneously and extremely dense breast tissue.
    • “In a letter sent to the Centers for Medicare & Medicaid Services Friday, the medtech industry group said many individuals with dense breasts currently have to pay out of pocket or forgo potentially life-saving additional testing.
    • “Advamed made the request two months after the Food and Drug Administration began requiring mammographers to notify patients when they have dense breast tissue. Traditional mammography is less sensitive than other imaging technologies in dense breasts, which increases the risks of imaging to miss cancer.”

From the public health and medical research front,

  • The American Hospital Association News lets us know,
    • “The Centers for Disease Control and Prevention Nov. 6 released its annual progress report on health care-associated infections, which showed continued decreases in hospitalizations last year. There was a 16% decrease in hospital-onset methicillin-resistant Staphylococcus aureus, or MRSA; a 15% decrease in central line-associated bloodstream infections, or CLABSI; a 13% decrease in hospital-onset Clostridioides difficile (C. difficile) infection; an 11% decrease in catheter-associated urinary tract infections; and a 5% decrease in ventilator-associated events. The declines align more closely with progress made prior to the COVID-19 pandemic in 2020, the CDC said. 
    • “For inpatient rehabilitation facilities, there was a 14% decrease in hospital-onset C. difficile infection and an 8% increase in CAUTI in 2023, but no significant changes in CLABSI and hospital-onset MRSA standardized infection ratios compared with 2022. Among long-term care hospitals, there was a 13% decrease in hospital-onset C. difficile infections but no significant changes in 2023 SIRs compared with 2022. 
    • “The report recommends facilities continue reinforcing prevention practices and review HAI surveillance data to identify areas for improvement.”
  • MedPage Today tells us,
    • The FDA announced marketing authorization of a form of light therapy as the first-ever treatment for dry age-related macular degeneration (AMD).
    • LumiThera’s Valeda Light Delivery System generates light at different wavelengths to stimulate and improve the function of retinal mitochondria. The photobiomodulation (PBM) system is the first treatment shown to improve vision loss associated with dry AMD.
    • “Patients will now be able to try a non-invasive treatment that can help improve their vision earlier in the disease process,” said David Boyer, MD, of Retina Vitreous Associates Medical Group in Beverly Hills, California, in a company statement. “This is an exciting option for patients, and something doctors and patients have been waiting for.”
  • The National Cancer Institute informs us,
    • “Every year, almost 90,000 of these adolescents and young adults (AYAs)—generally defined as people between the ages of 15 and 39—receive a cancer diagnosis. And this group of patients often needs extra help navigating the complexities of cancer care.
    • “A new study has shown that a program in place for a decade at the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center substantially increased its assistance to AYAs with cancer being treated at the center. For example, there were large increases in the number of AYAs who underwent fertility counseling, a particularly important consideration for this age group. The program also substantially boosted AYA enrollment in clinical trials and helped more AYAs get other care recommended by national guidelines. 
    • “The UNC team is now working to standardize many components of the program so it can be adapted by other cancer centers, explained Jacob Stein, M.D., M.P.H., who presented the findings from an evaluation of the program in September at the American Society of Clinical Oncology’s Quality Care Symposium.
    • “A lot of [centers] are now reaching out and asking: ‘How do we do this?’” said Dr. Stein. And the timing is right for the wider availability of programs to help AYAs with cancer, he added.
    • “Studies are showing that cancer is on the rise in younger adults,” he said. “That’s a concerning trend, but there are a lot of folks now engaged and talking about cancer in AYAs in a way that we weren’t 5 or 10 years ago.”
  • and
    • “[H]ow well does telehealth perform when it comes to delivering palliative care for people with cancer, which can rely on a deeper level of connection between patients and providers than may be possible with a virtual visit?
    • “A study of 1,250 people with advanced lung cancer has now provided some insights into that question. The study found that virtual and in-person palliative care were similarly effective in improving patients’ quality of life and other important measures of well-being, according to findings published September 11 in JAMA. It also found benefits for caregivers. 
    • “The results show that “we can successfully deliver … high-quality [palliative] care in person and virtually,” said Joseph A. Greer, Ph.D., of Massachusetts General Hospital, who led the study.
    • “The study results also have implications for the accessibility of palliative care, Dr. Greer noted. Telehealth provides a way for people with cancer who live in rural areas where there may not be many palliative care providers or who don’t have reliable transportation to receive palliative care. 
    • “Many of us see the potential that telehealth can have, and studies like this go a long way to help provide the evidence” needed to demonstrate that it can be used effectively as part of something as complex as palliative care, said Roxanne Jensen, Ph.D., of NCI’s Healthcare Delivery Research Program, who was not involved in the study.” 
  • Per Healio,
    • “Respiratory syncytial virus vaccines proved highly effective at preventing hospitalization and ED visits in older adults, even in those with immunocompromising conditions, results from an observational analysis showed.
    • “The findings, published in The Lancet, are consistent with previously reported data on respiratory syncytial virus (RSV) vaccine effectiveness.”
  • Per Medscape,
    • “Nilotinib, a drug approved by the US Food and Drug Administration (FDA) to treat chronic myeloid leukemia, improved biomarkers and cognitive outcomes in patients with dementia with Lewy bodies (DLB) in a phase 2 randomized, double-blind, placebo-controlled trial. 
    • “The findings align with an earlier study that showed possible disease-modifying effects of nilotinib in patients with mild cognitive impairment or Alzheimer’s disease, as previously reported by Medscape Medical News. 
    • “We’re looking at repositioning or repurposing tyrosine kinase inhibitors for neurodegenerative diseases,” said study investigator Raymond Scott Turner, MD, PhD, of Georgetown University School of Medicine in Washington, DC.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS reported mixed third-quarter results shadowed by heightened medical costs on Wednesday, in the massive healthcare enterprise’s first earnings report with new CEO David Joyner at the helm.
    • “The Woonsocket, Rhode Island-based company beat Wall Street expectations on revenue of $95.4 billion, up more than 6% year over year. However, CVS’ net income fell to $71 million, down from almost $2.3 billion same time last year, as its Aetna insurance arm continued to struggle with higher spending.
    • “CVS appointed Steve Nelson, previously the CEO of value-based primary care company ChenMed, as president of Aetna. Nelson also ran UnitedHealthcare, the largest private insurer in the U.S., from 2016 to 2019.”
  • Health Affairs Scholar concludes,
    • “The No Surprises Act banned surprise billing and established a final-offer arbitration system, independent dispute resolution (IDR), to resolve disagreements between health plans and providers. One factor that arbiters must consider in the IDR process is the qualifying payment amount (QPA), the median contracted rate for the same or similar service in the same market as computed by health plans. We analyzed public IDR data from 2023 for the most common disputed professional service: evaluation and management of a moderate to severe emergency medicine visit. Providers won 86% of cases, with mean decisions 2.7 times the QPA. Private equity-backed providers won more often and higher monetary awards than other providers. The mean QPA was 2.4 times Medicare payments. Disputes were dominated by a small group of health plans and providers, so payments may not reflect the overall market for emergency services.”
  • Per Fierce Pharma,
    • “As other biopharma giants have divested their generics units to focus on the development and commercialization of innovative drugs, Teva has relied on its copycat business to help trigger its rebound under CEO Richard Francis.
    • “Wednesday, Teva revealed booming third-quarter sales for its generics and biosimilars. In the U.S., revenue from the knockoffs came in at $1.1 billion, which was a 30% increase year over year, or 7% sequentially. Sales of generics and biosimilars also were up 10% year over year in Europe.
    • “The figures contributed heavily to Teva’s overall success in the quarter. Its revenue of $4.3 billion topped analysts’ consensus of $4.14 billion and was a 13% gain year over year. With the result, Teva tweaked its annual guidance up by $100 million at both ends to a window of $16.1 billion to $16.5 billion.”
  • MedCity News notes,
    • “While employers are prioritizing mental and physical wellbeing programs, employees report that what they really want is financial wellbeing support, according to a new survey.
    • “The survey was released last week by WTW, a global advisory, broking and solutions company. It included responses from 535 employees at medium and large private sector employers.
    • “The organization found that 73% of employers prioritize mental wellbeing and 50% prioritize physical wellbeing. However, 66% of employees say that financial wellbeing is their biggest concern. For employers, only 23% of respondents listed this as a priority. This comes as just 41% of employees feel financially secure, according to the survey.”