Thursday Report

Federal employment benefits

Thursday Report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, No Surprises Act, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • This evening, the House of Representatives turned down the President-elect approved, 121-page long version of the Continuing Resolution this evening. The Wall Street Journal adds that “Talk circulated among lawmakers about a possible weeklong funding extension, which would push the shutdown deadline past Christmas. But that too would need bipartisan support to get through the Senate.” The current CR funding the federal government expires at 12:01 AM on December 21.
  • Govexec informs us,
    • “The House passed a compendium of veterans care proposals, packaged into a single bill, on Monday, sending it to the president’s desk in the waning days of the congressional session. 
    • “The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (S.141) — which provides the Veterans Affairs Department with everything from community care improvements to expanded home care and educational assistance benefits — cleared the chamber in a 382-12 vote Monday night after previously passing the Senate by unanimous consent on Dec. 12.
    • “The legislation serves as an omnibus package of previous House and Senate bills designed to improve VA community care offerings, quality care standards and other programs, while offering benefit increases for veterans and some providers. 
    • “We worked hard to craft this legislation to put veterans – not government bureaucracy – at the core of it,” said House Veterans Affairs Committee Chairman Mike Bost, R-Ill., in a statement. “The Dole Act will do that by expanding economic opportunities, simplifying the disability claims process, reforming services for aging veterans, opening more doors for mental health support and a lot more.”
  • Federal News Network lets us know,
    • “Federal agencies will be closed on Tuesday, Dec. 24, President Joe Biden announced, giving federal employees an extra day off the day before Christmas.
    • “The president made the announcement via an executive order that he signed Thursday.
    • “All executive departments and agencies of the Federal Government shall be closed and their employees excused from duty on Tuesday, December 24, 2024, the day before Christmas Day,” the executive order states.”
  • Modern Healthcare reports,
    • “A mandatory hospital payment model finalized this year by the Centers for Medicare and Medicaid Services could make earnings uncertain for providers, researchers said.
    • “Under the Transforming Episode Accountability Model, or TEAM, hospitals could lose out on an average of $500 per episode of care covered in the model, according to a December report from the Institute for Accountable Care. But the forecast results vary widely: Hospitals in the Minneapolis-St. Paul region could gain an average of $900 per episode of included care, the report said, while Denver providers stand to lose $1,300 per episode, on average. 
    • Beginning in 2026, TEAM sets 30-day episode-based payments for lower-extremity joint replacements, femur fracture surgeries, spinal fusions, coronary artery bypass grafts and major bowel procedures. CMS will set bundled payments for these services based on regional benchmarks. In other words, hospitals will need to reduce spending for select care to a threshold set by their neighbors, or risk having to make up the difference.  
    • “It creates a really strong incentive” to manage costs, said Rob Mechanic, executive director of the Institute for Accountable Care, an independent nonprofit initially funded by the National Association of ACOs. On the flip side, he said, the regional benchmarks mean hospitals can significantly reduce their costs but still lose money.
    • The government selected 741 hospitals to participate in the five-year model, which gives safety-net hospitals extra time to prepare before taking on downside risk. Since the model is mandatory, hospitals can’t opt out. Ambulatory surgical centers are not included. According to the IAC report, the covered services represent about 15% of Medicare revenue, on average, for participating hospitals.

From the judicial front,

  • The Wall Street Journal reports,
    • “Federal prosecutors charged ex-Ivy Leaguer Luigi Mangione with murder and stalking Thursday for the Dec. 4 shooting of UnitedHealth executive Brian Thompson, alleging he was arrested with a notebook stating an intent to “wack” the CEO of an insurance company.” * * *
    • “The latest charges, brought by the Manhattan U.S. attorney’s office, mean federal prosecutors could pursue a death-penalty case against him.” * * *
    • The new federal charges capped a whirlwind day that began in Pennsylvania, where Mangione agreed at a hearing to waive his right to contest his transfer to New York. He had been detained in Pennsylvania since his arrest last week.”

In Food and Drug Administration News,

  • Healthcare Dive relates,
    • “The Food and Drug Administration on Thursday reaffirmed its assessment that Mounjaro and Zepbound, popular drugs for diabetes and obesity, are no longer in shortage,
    • “The agency’s decision will largely prevent so-called compounding pharmacies from making off-brand copies of the drug, closing a lucrative market niche that had opened as Eli Lilly, the drug’s maker, found itself unable to meet skyrocketing demand.
    • “However, the FDA won’t take enforcement action against compounding pharmacies until early next year, a grace period the agency said is to “avoid unnecessary disruption to patient treatment.”
  • Per STAT News,
    • “Ionis Pharmaceuticals on Thursday won Food and Drug Administration approval for a therapy that treats patients with a rare and deadly genetic disease that impedes the body’s ability to break down fats, setting the stage for the company to kick off the first solo drug launch in its 35-year history.
    • “The treatment, Tryngolza, also known by its scientific name of olezarsen, was approved for patients with familial chylomicronemia syndrome, or FCS, on the basis of late-stage trial results showing the therapy lowered triglyceride levels and was generally safe. Patients on the drug were less likely to develop an inflamed pancreas, an excruciating and sometimes life-threatening complication.
    • “Ionis executives believe the drug could also help patients with more common forms of sky-high triglycerides and have ongoing trials aiming to show that. If the drug is approved for more common conditions, market analysts have forecasted that Tryngolza could bring in $1.8 to $2 billion in peak sales.”
  • and
    • “Spinal cord injuries dramatically reduce a person’s mobility and independence, but a new device could aid rehabilitation efforts.
    • “Onward Medical received Food and Drug Administration clearance on Thursday for its non-invasive spinal cord stimulator, the ARC-EX. In a recent trial, the stimulator boosted hand sensation and strength in 72% of participants. While the treatment cannot replace rehabilitative therapy, device users rave about its effects.
    • “They tell patients the golden window of recovery is that first year or two,” said Sherown Campbell, one of the trial participants who signed up after he broke his neck wrestling in 2014. “I’ve made significant progress since then. I didn’t think that I would be able to move as much as I do, or I guess, as close to normal as I am.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is announcing a final rule to update the definition of the nutrient content claim “healthy.” There is an ever-growing crisis of preventable, diet-related chronic diseases in the U.S. that requires immediate action. The updated “healthy” claim marks an important step in fulfilling the FDA’s nutrition priorities, which are part of a whole-of-government approach to address this crisis. This rule will help ensure that consumers have access to more complete, accurate, and up-to-date nutrition information on food labels.
    • “The “healthy” claim has been updated to help consumers find foods that are the foundation of a healthy dietary pattern and could also result in the development of healthier foods. Manufacturers can voluntarily use the “healthy” claim on a food package if a product meets the updated definition.”
  • The Wall Street Journal adds,
    • “Under the updated claim, eggs, nuts and seeds, olive oil and higher-fat fish such as salmon will now qualify to use the “healthy” claim. Examples of products that qualified as healthy under the original claim but not the updated one include fortified white bread, highly sweetened yogurt, and highly sweetened cereals.
    • The agency said it would work with interested parties to support use of the updated claim, adding it had entered a partnership with grocery-delivery company Instacart to help shoppers find products.
    • Both the original and updated claims have limits on saturated fat and sodium. The updated claim has a limit on added sugars, while ending the limit on total fat.

From the public health and medical research front,

  • The American Hospital News lets us know,
    • “Life expectancy in the U.S. grew an average of 10.8 months in 2023, to 75.8 years for men and 81.1 years for women, according to a report by the Centers for Disease Control and Prevention. The overall death rate declined by 6%.  
    • “The 10 leading causes of death were unchanged from 2022, with heart disease, cancer and unintentional injuries remaining the top three. COVID-19 dropped from fourth to 10th, which moved stroke up to fourth, followed by chronic lower respiratory diseases, Alzheimer’s disease, diabetes, kidney disease, and chronic liver disease and cirrhosis.”
  • Per Healio,
    • “As many as 15 million adults in the United States have a 10% or greater risk for heart failure, results of a research letter published in Annals of Internal Medicine showed.
    • “The majority of those at higher risk for heart failure (HF) had uncontrolled modifiable risk factors for the condition, including obesity and hypertension, according to the researchers.
    • “Identifying populations at such a risk, along with implementing prevention strategies, “has the potential for dramatic public health impact,” the researchers wrote.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes in her blog,
    • “Clinical trials are essential for advancing new treatments that improve patient care and lives. But far too many clinical trials face challenges in identifying and enrolling eligible trial participants. Now, an NIH-led team has introduced an artificial intelligence (AI) tool that promises to speed up the process of matching patients to clinical trials to help boost enrollment. They call it TrialGPT.
    • “As reported in Nature Communications, TrialGPT takes advantage of large language models, a type of AI that can generate human-like responses to questions and explanations familiar to users of ChatGPT. The research team adapted it for matching patients to thousands of possible clinical trials in a data-efficient and transparent way. While earlier studies have shown the potential for using this type of AI for answering clinical questions, designing clinical trials, and retrieving initial lists of potential trials, TrialGPT is the first end-to-end solution, generating a list of potential trials before more precisely matching and ranking them. The team’s preliminary testing of this tool suggests TrialGPT can achieve a high degree of accuracy while cutting the time required of clinicians for screening patients. * * *
    • “In a pilot user study conducted at NCI, the researchers compared patient-trial evaluations based on short summaries about six patients made by one medical expert with TrialGPT and another who made the same evaluation manually without TrialGPT. Both experts conducted evaluations with and without AI to account for any differences in their speed or skill. The study found that clinicians using TrialGPT could generate similarly accurate lists of trial options in 40% less time.
    • “More study is needed to assess TrialGPT’s practical application in real-world settings across diverse groups of patients. But these findings already show the remarkable potential of AI technology for connecting patients to relevant trial opportunities, with tremendous potential for speeding trial recruitment and treatment advances while giving clinicians more time for other tasks only humans can do, including caring for their patients.”
  • The National Heart, Lung and Blood Institute offers an update featuring the “latest research on hypertension, educational resources on blood donation, and more.”
  • The Wall Street Journal reports,
    • “Roche said a Parkinson’s disease experimental drug missed its primary goal in a mid-stage trial, the second setback this week for candidate treatments for the neurodegenerative condition.
    • “The update from the Swiss pharmaceutical giant came after Belgian peer said a similar drug candidate for Parkinson’s developed jointly with Novartis failed to meet key goals in a clinical trial.
    • “Roche said Thursday that its drug candidate, prasinezumab, didn’t delay progression of motor symptoms in the trial, which included early-stage Parkinson’s patients, to an extent considered statistically significant.
    • “However, the company said the drug did show potential clinical efficacy, as well as positive trends on several other goals of the trial and was well tolerated. Roche will continue to evaluate the data and work together with health authorities to decide on next steps, it said.”
  • Per BioPharma Dive,
    • “Merck & Co. has long been dominant in cancer immunotherapy, with its drug Keytruda earning 40 approvals en route to becoming the world’s best-selling medicine. But the New Jersey-based drugmaker has had difficulty finding a successor, and a Monday announcement is the latest evidence.
    • “In a statement, Merck said it will end development of two experimental cancer drugs that are currently in late-stage testing. One, called vibostolimab, is aimed at a target called TIGIT. The other, favezelimab, homes in a protein named LAG-3. Both were being evaluated in combinations with Keytruda and have been touted by Merck as a way to extend Keytruda’s market advantage beyond 2028, when its main U.S. patent will expire.”

From the U.S. healthcare business front,

  • The Wall Street Journal explores the question “Why Are Americans Paying So Much More for Healthcare Than They Used To?”
    • “National healthcare spending increased 7.5% year over year in 2023 to $4.867 trillion, or $14,570 per person, according to data released Wednesday by the Centers for Medicare and Medicaid Services. 
    • “Total spending on healthcare goods and services, everything from prescription drugs to back surgeries, accounted for 17.6% of gross domestic product, a measure of goods and services produced by the U.S. economy.
    • “The 7.5% rise represented a much faster pace of growth than the 4.6% increase in 2022. It came as pandemic federal funding for the healthcare sector expired and private health insurance enrollment increased. More people with insurance led to increased demand for medical procedures, and spending on hospital care grew at the fastest pace since 1990. Spending on drugs also rose, including for medications to treat diabetes and obesity.  
    • “A full 92.5% of Americans were covered by insurance last year, and 175.6 million, or just over half the population, got it through their employer, according to the government’s new annual data. 
    • “Over 65 million Americans are on Medicare, a government health-insurance program mainly for people ages 65 and older, and nearly 92 million are on Medicaid, a state-federal program for the low-income and disabled.”
  • STAT News relates,
    • “Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found.
    • “Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other medicines before insurers approve a prescription. The formularies are run by health plans, pharmacy benefit managers, and the U.S. Department of Veterans Affairs.
    • “But only 81% of the formularies scored well on a fourth criterion: cost-sharing, which is the portion of expenses paid by insured individuals. Although there is a caveat: This particular metric was based on a subset of just three drugs that were deemed to be fairly priced based on a cost-effectiveness assessment — the Mounjaro type 2 diabetes treatment, and the Wegovy and Qsymia obesity drugs.
    • “Meanwhile, transparency into coverage information for three gene therapies — Zynteglo for combating beta thalassemia, the Hemgenix hemophilia B treatment, and Roctavian for treating hemophilia A — remains less than optimal. Of the six formularies covering the therapies, 83% provided clinical criteria, cost-sharing information was only available in two or three, and none provided site of care information.”
  • Per Fierce Healthcare,
    • “Tech platform Uno Health is rolling out a self-service guide that shows users financial savings they could be eligible to obtain.
    • “The tool boasts of its ability to save the average user $4,500 a year after asking just a few questions. It is designed to improve accessibility and simplify the application process for everything ranging from federal and state health programs, heating bills, phone and internet services and the Supplemental Nutritional Assistance Program.
    • ‘These programs and benefits can be difficult for individuals to sift through, potentially leaving hundreds, or thousands, of dollars on the table if they do not enroll. Uno Health CEO Anna de Paula Hanika, formerly at Clover Health and Google, says the tool is an encapsulation of the company’s broader offerings.
    • “She said at least 50% of Medicare members are eligible for, but not enrolled in, other financial assistance programs. That figure increases to nearly 90% for Medicaid members. Unused benefits strain health programs and insurers.”

Thursday Report

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec tells us,
    • “Senate Majority Leader Chuck Schumer told unions and federal employee groups Wednesday that he will schedule a vote on the Senate floor on legislation to repeal two controversial tax provisions that reduce some public servants’ retirement benefits just weeks before the end of the congressional session and Democrats’ control of the chamber.
    • “Schumer’s remarks came at a rain-soaked rally, organized by lawmakers and organized labor on Capitol Hill in support of the Social Security Fairness Act (H.R. 82), which passed the House by a 327-75 vote last month.” * * *
    • “If enacted, the legislation would repeal Social Security’s windfall elimination provision and government pension offset. The windfall elimination provision reduces the Social Security benefits of retired federal employees who spent a portion of their careers in the private sector in addition to a federal, state or local government job where Social Security is not intended as an element of their retirement income, such as the Civil Service Retirement System. And the government pension offset reduces spousal and survivor Social Security benefits in families with retired government workers.”
  • FedSmith adds,
    • “The OPM retirement backlog has dropped to levels not seen since 2016. As of the end of November 2024, the total outstanding retirement claims at the Office of Personnel Management is 13,844. The last time it was at or below that level was June 2016 when it was 13,529.
    • “OPM received 6,808 new retirement claims in November and processed 7,872. It took an average of 55 days to process claims.
    • “So far in 2024, the average level of the OPM retirement backlog is 16,083. The average number of retirement claims submitted by federal employees to OPM each month has been 7,558, and the average number processed each month is 7,599.
    • “The end of a year is the peak time for federal employees to retire, so it’s good news for federal employees who plan to retire soon that the number of pending retirement claims at OPM has fallen as the end of 2024 approaches.
    • “However, even though most federal employees retire at the end of a calendar year, the impact on the processing doesn’t hit until January. The peak time at OPM for processing retirement claims is January through March, and January is typically the month with the largest spike in the retirement backlog based on past data. For example, the OPM retirement backlog grew by 46% last January.”
  • BioPharma Dive lets us know,
    • “When the Food and Drug Administration took Eli Lilly’s Zepbound and Mounjaro off of its drug shortage list in October, companies making cheap “compounded” versions found themselves in a bind.
    • “By ending compounders’ ability to manufacture and sell their off-brand versions in bulk, the FDA’s decision also left some patients wondering how they would be able to access the popular obesity and diabetes drugs at an affordable price. About 12% of American adults have taken a GLP-1 medication, according to a May poll from KFF Health. And compounded versions may account for as much as 20% of all GLP-1 prescriptions, CNN reported.
    • “But when the FDA backed down, letting compound pharmacies resume their activities for the time being, the industry was left in something of a limbo. * * *
    • “The FDA said it will issue another update Dec. 19, although it’s possible it will be another extension of the review. The agency said in a late November joint status update to a court hearing the compounders’ challenge that it had not yet made a determination, according to Beaver.
    • “In the interim period, FDA has indicated it does not intend to take enforcement action against the continued compounding of tirzepatide,” Beaver said.
    • “With a new presidential administration set to take over next month, the FDA may simply wait.”
  • STAT News adds,
    • “Eli Lilly, which has been directing patients to various telehealth sites as it sells its blockbuster obesity medication Zepbound, is broadening its reach, announcing a partnership Wednesday with major telehealth platform Ro.
    • “Under the new agreement, Ro patients who are prescribed Zepbound will be able to get vials of the drug through its app. Previously, Lilly had only made these vials, which are priced lower than its injectable pens, available to patients who filled prescriptions through an online portal created by Lilly, called LillyDirect.”
  • MedTech Dive offers “four takeaways from the FDA’s first digital health advisory committee. Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology.”

From the judicial front,

  • Reuters informs us,
    • “The U.S. Department of Health and Human Services overstepped its authority when it boosted Medicare reimbursements to hospitals in low-wage areas to help them recruit and retain staff, a divided federal appeals court ruled on Wednesday.
    • “A 2-1 panel of the San Francisco-based 9th U.S. Circuit Court of Appeals found that HHS’s 2020 policy shift ran afoul of the law governing Medicare, the federal health insurance program for seniors and some people with disabilities.
    • “The decision was a victory for a group of 53 California hospitals that sued HHS in 2020 in Los Angeles federal court, saying their Medicare reimbursements were cut by a total of about $3.8 million to make up for the increased payments to hospitals in low-wage areas.
    • “HHS said earlier this year that it would not continue the policy in 2025, meaning that Wednesday’s decision will affect only reimbursements for past years going back to 2020.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “When a woman learns she has breast cancer, her reaction is often: take it out. Now doctors say that might not always be necessary.
    • “Some women with the earliest stages of breast cancer could be carefully monitored, undergoing surgery and radiation only if the disease advances, new data suggests.
    • “The strategy is akin to one already used in early prostate cancer, as doctors are increasingly looking at whether they can pull back on some cancer therapies, to spare patients side effects and costs.
    • “This is really the first study to confirm our suspicions that there’s a subset of low-risk patients that could do just as well without surgery,” said Dr. Nancy Chan, a breast-cancer specialist at NYU Langone’s Perlmutter Cancer Center, who wasn’t involved in the study. “It’s really encouraging.” * * *
    • “It was a data-free zone because we already treated it like a cancer,” said Dr. E. Shelley Hwang, a breast-cancer surgeon at Duke Cancer Institute, who led the trial. “We didn’t know what we could dial back on.”
    • Hwang and her colleagues recruited some 950 women ages 40 and older with a type of low-risk DCIS that is sensitive to hormones. The women were split into two groups: One was recommended standard care—surgery with or without radiation—while the other was recommended mammograms every six months. The monitoring group could opt for surgery at any time and had to get surgery if the disease progressed.
    • Most women in both groups took hormone therapy to help keep cancer growth in check. Some 17% of women in the monitoring group ended up getting surgery, and some assigned to the treatment group declined to get an operation.
    • Two years later, the rates of women who developed invasive breast cancer were similar between the groups, less than 10%, the researchers found. The women also reported comparable rates of anxiety, a concern when doctors are considering dialing-back treatment.
    • Women who got standard care reported more arm problems and breast pain, but that resolved over time. The results were published in the academic journals JAMA and JAMA Oncology and presented at the San Antonio Breast Cancer Symposium on Thursday.
  • STAT News points out,
    • “Pfizer said Thursday its drug Ibrance showed efficacy in a group of breast cancer patients who do not currently have access to the medicine, potentially expanding its use.
    • “Ibrance, which generates annual sales of $4.3 billion, is currently used for patients whose tumors are positive for the estrogen receptor (ER) and negative for a second biomarker, called HER2. That population represents 70% of women with breast cancer. But the new results are in patients whose tumors test positive for both the estrogen receptor and HER2, a population that represents 10% of breast cancer patients.”
  • The New York Times relates,
    • “Over the last 20 years, clinicians have increasingly recognized that A.D.H.D. symptoms, which begin in childhood, can linger into adulthood, and that some groups — like women and people of color— are more likely to be underdiagnosed early in life. Now, with the rise of telemedicine, increased awareness of A.D.H.D. and changing attitudes about mental health treatment, new A.D.H.D. diagnoses are surging among older Americans.
    • “An analysis by Truveta, a health care data and analytics company, shows that the rate of first-time A.D.H.D. diagnoses has been on the rise since 2021, but the increase has occurred only among people 30 and older. From January 2021 to October 2024, the rate of first-time diagnoses rose about 61 percent among those ages 30 to 44 and 64 percent among those ages 45 to 64.
    • “As a result, about 31 percent of first-time diagnoses are now among people ages 30 to 44, the largest proportion of any age group. (In 2018, younger adults took the top spot.)
    • “The analysis, which was done at the request of The New York Times, drew on Truveta’s database of 30 health systems, which included more than one million people who had received first-time A.D.H.D. diagnoses.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes,
    • “In people with brain tumors known as diffuse gliomas, cancerous cells often spread and invade nearby tissue to mix with healthy cells. As a result, it can be challenging for neurosurgeons to differentiate cancerous from healthy tissue during surgery as is required to safely remove as much of the cancer as possible. Many patients with glioma are found to have residual tumor after surgery, which can mean additional surgeries, earlier recurrence, and decreased survival. But research is showing that artificial intelligence (AI) tools could enable doctors to not only predict if a cancer will respond to treatment, but also to differentiate cancerous from healthy tissue rapidly enough to guide more brain surgeries in real time.
    • “In one promising example of this, an NIH-supported study in Nature  recently reported the development of an open-source, AI-based diagnostic system that can determine in just 10 seconds if part of a cancerous brain tumor that could be removed still remains. The new system, called FastGlioma, combines rapid, user-friendly, optical microscopy with AI models trained on diverse data, including over 11,000 surgical specimens and 4 million microscopy images, to give surgeons needed answers very quickly.
    • “Today, neurosurgical teams locate residual tumor during surgery guided by MRI or fluorescent imaging. The research team for this study—led by Todd Hollon , University of Michigan Health, Ann Arbor, and Shawn Hervey-Jumper , University of California, San Francisco—reports that the new system significantly outperforms current methods for identifying tumor remains, working faster and more accurately.” * * *
    • “The presence of residual tumor tissue following surgery is a significant and costly public health problem in the U.S. and around the world, for brain cancers and other solid cancers alike. The research team reports that FastGlioma can already accurately detect residual tumor in many other brain cancer types, including both adult and childhood brain cancers, suggesting it has potential to one day serve as a general-purpose tool for guiding brain tumor surgeries. The researchers also plan to explore the system’s application to other cancers, including lung, prostate, breast, and head and neck cancers. Through this kind of work, the researchers hope this tool and others like it can help unlock the potential of AI for improving cancer care in the years ahead.”
  • Per MedPage Today,
    • “Postmarketing data on obeticholic acid (Ocaliva) identified a risk for serious liver injury in primary biliary cholangitis (PBC) patients without cirrhosis, the FDA said in a safety communication on Thursday.
    • “The agency’s review of a mandated clinical trial “found that some cases of liver injury in patients without cirrhosis resulted in liver transplant. This risk was notably higher for patients taking Ocaliva compared with a placebo,” the FDA said.”
  • Per Beckers Hospital Review,
    • “The FDA has placed a hold on all clinical studies of vaccines for respiratory syncytial virus in infants due to safety concerns following a trial involving two mRNA-based vaccine candidates from Moderna. 
    • “A briefing document released by the FDA ahead of the Vaccine and Related Biological Products Advisory Committee revealed that a phase 1 trial evaluating two RSV vaccines in infants aged 5 to 8 months was paused in July after five severe cases of RSV-related illness were reported among infants receiving the vaccine candidates.” * * *
    • “VRBPAC will review the safety data and discuss implications for the future development of RSV vaccines for infants Dec. 12.” 

From the U.S. healthcare business front,

  • Per a press release,
    • The Institute for Clinical and Economic Review (ICER) today published its latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States, highlighting the top 10 drugs with substantial net price increases in 2023. ICER determined that five of those drugs lacked adequate evidence to support any price increase, which resulted in a total of $815 million incremental added costs to US payers in 2023. The five drugs with unsupported price increases are Biktarvy, Darzalex, Entresto, Cabometyx, and Xeljanz.
    • Downloads: Final Report
    • “We continue to see list price increases that are far above the rate of inflation for many of the costliest drugs,” stated Foluso Agboola, MBBS, MPH, ICER’s Vice President of Research. “These price hikes resulted in over $800 million in excess costs to the US health care system in just one year alone. This impacts everyone in the country, especially patients and their families. Over the past few years, ICER has played a role in highlighting substantial price increases. Since launching this report in 2019, we have noticed a decrease in the number of drugs that have significant price hikes without any new clinical evidence. In this report, half of the drugs we assessed had price increases in the setting of new evidence of additional benefits or reduced harm, while the other half lacked such evidence to support their higher price tag.”
  • STAT News discusses “AI versus AI: The emerging arms race over health insurance denials. New startups are harnessing artificial intelligence to appeal denials by health insurers.
    • “Like many Americans, Holden Karau said she was fed up with health insurance. * * *
    • Karau’s company, FightHealthInsurance.com, is one of many upstart businesses seeking to harness the power of artificial intelligence to combat denials by health insurers that block access to medical services.
    • “There’s a lot of technology on the insurance side to automate denials,” Karau said. “I think it’s time to build the tools for patients and providers.”
    • “Her company, and its companions in the market, are just getting off the ground. But they promise to help automate appeals for providers and patients, making it much faster and easier to contest denials that often go unchallenged.”
  • Beckers Hospital Review shares weight loss drug fills by states.
    • “Alaska recorded the highest percentage of medication fills for weight loss drugs this year, according to data from GoodRx. 
    • “To assess state-level trends, GoodRx examined fill rates for all medications, excluding vaccines, from a nationally representative sample between Jan. 1 and Oct. 31. The figures below reflect the percentage of total medication fills for GIP and GLP-1 drugs prescribed for either diabetes or weight loss indications. Medications for Type 2 diabetes included Ozempic, Mounjaro, Victoza and liraglutide, while medications prescribed for weight loss included Wegovy, Zepbound, Saxenda, Qsymia and phentermine.
    • “Regionally, states in the South had higher fill rates for medications prescribed for diabetes while states in the Northeast had the highest fill rates for medications prescribed for weight loss.” 
  • and points out “US News’ 118 maternity care access hospitals.”
    • “On Dec. 10, U.S. News & World Report released its annual Best Hospitals for Maternity Care ratings, which also recognize hospitals providing services to underserved communities.
    • “U.S. News identified 118 hospitals as Maternity Care Access Hospitals for providing maternity services in areas that would otherwise lack access to such care.
    • “To qualify, these hospitals met specific geographic and quality criteria. They were eligible if they were the only hospital providing maternity care within their county, and the county had fewer than 60 obstetric providers per 10,000 births. Alternatively, hospitals qualified if they were the only facility within a 15-mile radius and were located in a county with fewer than 128 obstetric providers per 10,000 births.”
  • Per Fierce Healthcare,
    • “Centene released its earnings guidance for 2025 as a part of its investor day on Thursday.
    • “The health insurer expects to bring in between $166.5 billion and $169.5 billion in revenue for the year, including between $154 billion and $156 billion in premium and service revenue, according to the announcement. It also estimates earnings per share of at least $7.25 in 2025.
    • “The company is bracing for elevated utilization trends to continue as well, according to the announcement. It projects a medical loss ratio of between 88.4% and 89%.”

Weekend update

David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare, Uncategorized–
  • The Wall Street Journal reports
    • “Days after a hooded and masked man fatally shot a UnitedHealthcare executive in Manhattan, investigators have learned key details about the gunman’s stay in the city and how he planned his crime.
    • “Investigators are looking at the possibility that the shooter might be a disgruntled ex-employee of Brian Thompson’s insurance company or an angry client, according to NYPD Chief of Detectives Joseph Kenny. Investigators have been in touch with Thompson’s family, but there is no indication the shooting involved his private life, police said.
    • “New York Mayor Eric Adams told reporters Saturday that police have a name for the suspect but declined to disclose it pending the investigation. “The net is tightening,” the mayor said outside a Police Athletic League event in Harlem, according to footage from MSNBC. A New York police spokesman late Saturday said he couldn’t confirm that the department has the name of a suspect.
    • “The shooter might have used a large handgun, or possibly a veterinary gun, a firearm used to put down animals that doesn’t make a lot of noise, police said.
    • “The assailant likely left New York on a bus early Wednesday, not long after he fatally shot Thompson outside a hotel in Midtown Manhattan, investigators said. But he left behind a critical piece of evidence: the backpack he wore during the shooting and apparently abandoned in Central Park. Police found a bag there Friday afternoon.

From Washington, DC,

  • OPM reminds us,
    • “OPM has extended Open Season for the Postal Service Health Benefits Program through Friday, December 13th at 11:59 pm EST. This extension is only for the PSHBP. This does not extend to FEHB or other benefits programs. The deadline for FEHB remains 11:59 pm, in the location of your electronic enrollment system, on Monday, December 9th.”
  • Federal News Network tells us,
    • “Office of Personnel Management Acting Director Rob Shriver sees several areas of opportunity to build on the forward momentum to reform federal hiring and retention.
    • “During the Biden administration, the President’s Management Agenda focused one of its key priorities on strengthening and empowering the federal workforce. Though the efforts of the PMA are now coming to a close, administration officials pointed to promising signs of an improving federal hiring process.
    • “For example, the Biden administration has taken steps to keep the ball rolling on a push toward skills-based hiring. In April, the White House announced plans to transition the government’s primary job series for federal IT specialists away from college degree requirements over the next year.
    • “This really picked up on an initiative from the prior administration, and we’ve been grinding through the implementation of that,” Shriver said in an interview with Federal News Network at a Dec. 4 White House event. “But there are also a lot of challenges to implementing true skills-based hiring.”

From the public health and medical research front,

  • Cardiovascular Business informs us,
    • “Heart surgeons with the WVU Heart and Vascular Institute have made a bit of history, performing the world’s first combined robotic aortic valve replacement (AVR) and coronary artery bypass grafting (CABG) procedure—all through one small incision. Patients requiring these procedures typically undergo open-heart surgery. 
    • “The patient in question, 73-year-old Poppy McGee, presented with a history of stroke, brain surgery and ongoing weight loss. She was referred to Vinay Badhwar, MD, executive chair of the WVU Heart and Vascular Institute and chair of WVU’s department of cardiovascular and thoracic surgery, who initially recommended open-heart surgery. However, when McGee and her family heard that the odds of dying exceeded 10%, they inquired about less invasive treatment options. 
    • “Badhwar, a known pioneer of robotic aortic valve replacement (RAVR) and other robotic surgical techniques, said his team had developed a new technique for combining AVR and CABG—but it had not yet been tested on a patient. After a long discussion with McGee and her family about the risks, she agreed to the new-look surgical treatment.
    • “The combined surgery occurred on Oct. 31, 2024. Both the AVR and the CABG were performed using the same small incision on the far right of McGee’s chest. The surgery was a success, and a detailed account is expected to publish in The Annals of Thoracic Surgery.” ***
    • “Goya Raikar, MD, a member of Badhwar’s robotics team and an assistant professor a WVU, highlighted the progress this successful procedure represents for their work on advancing robotic surgical techniques.
    • “Until now, the main exclusion for us to perform a robotic approach has been the coexistence of valve and coronary artery disease,” he said. “Building on our experience with robotic aortic valve surgery, this new approach may help us extend robotic surgery options to many more patients.”  
  • The Hill lets us know,
    • “A more potent form of fentanyl is contributing to the thousands of overdose deaths that happen every year, health officials warn.
    • “An extremely powerful derivative of fentanyl, called carfentanil, was detected in 513 overdose deaths between 2021 and early 2024, according to a report from the Centers for Disease Control and Prevention (CDC). 
    • “Carfentanil was designed to tranquilize large animals and is estimated to be 10,000 times stronger than morphine and 100 times stronger than fentanyl.  
    • “Just 2 milligrams is needed to tranquilize an elephant; that same amount is powerful enough to kill 50 people, according to a Department of Veteran Affairs report.
    • “Drug overdose deaths overall have been declining since 2023, according to the CDC. But they remain high in the United States, and the majority are connected to illegally manufactured fentanyls (IMFs).
    • “Carfentanil-related overdose deaths are becoming less rare, highlighting the “ever-changing illegal drug supply” that threatens the progress made in reducing overdose deaths, according to the report.” * * *
    • “Carfentanil-related deaths continued to rise this year, with a total of 238 people dying from the drug by June — a roughly 720 percent increase from the first half of 2023 to the first half of 2024.”
  • Per Medscape,
    • “Vaccines for treating and preventing cancer have long been considered a holy grail in oncology.
    • “But aside from a few notable exceptions — including the human papillomavirus (HPV) vaccine, which has dramatically reduced the incidence of HPV-related cancers, and a Bacillus Calmette-Guerin vaccine, which helps prevent early-stage bladder cancer recurrence — most have failed to deliver.
    • “Following a string of disappointments over the past decade, recent advances in the immunotherapy space are bringing renewed hope for progress.
    • “In an American Association for Cancer Research (AACR) series earlier this year, Catherine J. Wu, MD, predicted big strides for cancer vaccines, especially for personalized vaccines that target patient-specific neoantigens — the proteins that form on cancer cells — as well as vaccines that can treat diverse tumor types.
    • “A focus on neoantigens that arise from driver mutations in different tumor types could allow us to make progress in creating off-the-shelf vaccines,” said Wu, the Lavine Family Chair of Preventative Cancer Therapies at Dana-Farber Cancer Institute and a professor of medicine at Harvard Medical School, both in Boston.”
  • Fortune Well points out five symptoms that men over 40 should never ignore.
    • “Unexplained fatigue
    • “Chest discomfort
    • “Swelling in lower extremities
    • “Changes in exercise tolerance, and
    • “Loss of morning erections.”
  • NPR Shots reminds us,
    • “[I]nstead of chilling out in front of the TV after you polish off a scrumptious dessert, consider venturing out for a walk. It’s one of the easiest things you can do to boost your health after a meal, and even a short stroll can yield big benefits.
    • “The concept of post-meal walks has been around for centuries, notes Loretta DiPietro, a professor of exercise and nutrition science at the George Washington University Milken Institute School of Public Health.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “BioAge Labs said it is terminating a mid-stage study of its obesity drug candidate azelaprag in combination with Eli Lilly’s tirzepatide due to safety concerns, causing its share price to slide by three-quarters in after-hours trading Friday.
    • “Eleven people who received azelaprag in STRIDES, BioAge’s Phase 2 study, showed elevated levels of liver enzymes that can warn of potential organ damage. As a result, the company is discontinuing dosing and halting further enrollment.
    • “The San Francisco Bay Area company raised $170 million in February and banked a $198 million initial public offering in September to fund its ambitious foray into metabolic drugs, not long after it pivoted from making treatments for age-related diseases.”
  • MedTech Dive adds,
    • “Edwards Lifesciences predicted Wednesday that an expanded indication in transcatheter aortic valve replacement (TAVR) and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.
    • “Edwards anticipates mid-2025 approval for TAVR in people with asymptomatic severe aortic stenosis, the company said during an investor day event.
    • “The Sapien TAVR system is Edwards’ biggest product but has seen growth slow this year as hospital heart teams dealt with capacity constraints. Hospitals, however, are investing to increase capacity and avoid delays in patient treatment, which will support prioritization of aortic stenosis cases long term, Edwards said in its presentation.” 
  • The Journal of Accountancy lets us know,
    • “A federal district court, finding that the Corporate Transparency Act (CTA) is likely unconstitutional, issued an order Tuesday prohibiting the enforcement of the CTA and the beneficial ownership information (BOI) reporting rule in the CTA’s accompanying regulations.
    • “The injunction, which according to the court should apply nationally, was issued in Texas Top Cop Shop, Inc. vs. Garland, No. 4:24-CV-478 (E.D. Texas 12/3/24).
    • “Under the injunction, the CTA and the BOI reporting rule cannot be enforced, and reporting companies need not comply with the CTA’s Jan. 1, 2025, BOI reporting deadline pending a further order of the court.
    • “The Financial Crimes Enforcement Network (FinCEN), which enforces the CTA, is reviewing the order, a spokesperson said Wednesday, pointing out that other courts have denied similar requests. The Justice Department (DOJ) filed a notice of appeal on Thursday night.
    • “An AICPA statement, released before the DOJ notice of appeal, acknowledged the potential effects of the injunction and urged CPAs assisting clients with BOI reporting to be prepared.
    • “Under the injunction, FinCEN is barred from enforcing BOI filing requirements while the case is pending,” the statement said. “Best practices dictate that at a minimum those assisting clients with BOI report filings gather the required information from the clients and are prepared to file the BOI report if the injunction is lifted. While it is unlikely that the injunction will be lifted prior to the final outcome of the proceedings, we advise being prepared in the event that there is a reversal.”

Thursday Report

David Ermer–ACA, CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, OPM, Telehealth, U.S. Healthcare–

Healthcare Dive shares observations and news about yesterday’s murder of United Healthcare’s CEO Brian Thompson.

Yahoo News delves into the investigation of Mr. Thompson murder by the New York City Police Department. The FEHBlog has the utmost confidence that this investigation will end with at least one arrest.

From Washington, DC

  • Federal News Network informs us,
    • “Enrollees in the new Postal Service Health Benefits program will have a few extra days of Open Season to review their plan options and make changes to their benefits for plan year 2025.
    • “The Office of Personnel Management officially extended Open Season for PSHB participants until Dec. 13, Federal News Network has learned. Participants in the Federal Employees Health Benefits program and other federal benefits programs will still see Open Season end on the original Dec. 9 deadline.
    • “OPM said the transition to the new PSHB program is “a big change” for enrollees, and it’s extending Open Season by four days to give Postal employees, annuitants and their family members additional time to look at plans and make changes as they see fit.
    • “We feel it is important to extend Open Season for customers of the PSHB program to give them ample time to shop for plans and change their elections if they want to,” OPM said.
  • Tammy Flanagan, writing in Govexec, discusses Open Season and tax savings.
  • Politico reports,
    • “The House is losing several health policy leaders after this Congress, and they’ll likely want to make their mark in their last two months on Capitol Hill.
    • “While Congress negotiates its end-of-year legislative package, some key departing lawmakers are rallying to pass projects before their terms end — although expectations for a health care package are low. Historically, Congress has sometimes shown a willingness to give outgoing lawmakers a win.”
    • Politico shares the legacy goals of the retiring House members.
  • Among the bills for possible inclusion in the lame duck health care package is S. 1339, Pharmacy Benefit Manager Reform Act. The Congressional Budget Office issued a report on this bill today.
  • The Washington Post informs us,
    • “A bipartisan group of senators grilled Food and Drug Administration officials Thursday on the agency’s failure to more tightly regulate ultra-processed foods and food dyes, highlighting a key part of the health agenda promoted by Robert F. Kennedy Jr.
    • “Kennedy, President-elect Donald Trump’s controversial pick to lead the sprawling Department of Health and Human Services, which oversees the FDA, has blamed the nation’s surge of chronic disease and declining life expectancy on ultra-processed foods — a position that aligns with Sen. Bernie Sanders (I-Vermont), who convened the hearing as chairman of the Senate health committee.
    • “Congress and the FDA have allowed large corporations to make huge profits by enticing children and adults to consume ultra-processed food and beverages loaded up with sugar, salt and saturated fat,” Sanders said Thursday, pointing to the billions of dollars the food-and-beverage industry spends on advertising.”
  • Govexec notes,
    • “The leaders of President-elect Trump’s new advisory panel aiming to slash government spending, Elon Musk and Vivek Ramaswamy, met with Republican lawmakers at the Capitol on Thursday in what leaders pitched as an informational session to share ideas. 
    • “Congressional Republicans and a handful of Democrats have embraced Trump’s Department of Government Efficiency, which will function as a non-governmental commission, and on Thursday were eager to share their ideas for identifying areas for cuts. Some Republicans cautioned, however, that the advisory panel must work through the appropriate channels and win congressional support for their initiatives. 
    • “Nearly every House and Senate member that emerged from the various meetings called them productive and suggested a unifying idea supported by both lawmakers and Trump’s designated efficiency czars: recalling teleworking employees back to the office.”  
  • Per Department of Health and Human Services press releases,
  • and
    • “Today, the U.S. Department of Health & Human Services (HHS), Office for Civil Rights (OCR), issued a “Dear Colleague” letter – PDF to help federally funded health care providers, plan grantees, and others better understand their civil rights obligations under the new final rule on Section 1557 of the Affordable Care Act (“Section 1557”).  
    • “Section 1557 provides nondiscrimination protections by requiring covered entities (e.g., recipients of Federal financial assistance, programs administered by HHS, and entities established under Title I of the Affordable Care Act (ACA)) to provide language assistance to individuals with limited English proficiency (LEP) or disability.”
  • Modern Healthcare reports,
    • “Hospitals have expanded their legal push for the federal government to boost Medicare reimbursement.
    • “More than 500 hospitals last week sued the Health and Human Services Department for allegedly miscalculating a 40-year-old Inpatient Prospective Payment System base reimbursement rate that providers say has lowered years of subsequent Medicare payments to hospitals. The lawsuit is the latest in a series of similar complaints that allege the Health and Human Services Department must increase Medicare inpatient pay.
    • “Each lawsuit challenges different batches of denied requests to amend reimbursement rates, but the arguments are largely the same. Hundreds of millions of dollars are at stake, providers allege. If the federal government changes the inpatient base pay rate, hospitals stand to not only recoup money from prior fiscal years but also increase future reimbursement rates.”
  • The American Hospital Association News tells us,
    • “A $2.8 billion settlement from Blue Cross Blue Shield to health care providers resolving a 12-year antitrust lawsuit received preliminary approval yesterday from the U.S. District Court for the Northern District of Alabama. The settlement will also “significantly improve how Providers will interact with the Blues, bringing more transparency and efficiency to their dealings, and increase Blue Plan accountability,” according to the court filing. 
    • “The lawsuit alleged that BCBS member companies violated antitrust laws by agreeing to allocate markets via exclusive service areas and fixing prices paid to health care providers through the organization’s BlueCard Program.”
  • and
    • “Approximately 988,000 consumers who currently do not have health insurance coverage through the individual marketplace have signed up for a 2025 health plan through the federally facilitated Health Insurance Marketplace, the Centers for Medicare & Medicaid Services announced yesterday. Nearly 4.4 million returning consumers have selected 2025 plans. The open enrollment period began Nov. 1 and continues through Jan. 15.”
    • The deadline for January 1, 2025, enrollments is December 15, 2024. Later enrollments will begin on February 1, 2025.
  • and
    • “The Food and Drug Administration yesterday released recommendations for streamlining the approval process for medical devices that use artificial intelligence. The guidance recommends information to include in a predetermined change control plan as part of a marketing submission for a medical device using AI. The PCCP should include a description of the device’s planned modifications; methods to develop, validate and implement the modifications; and an assessment of the modification’s impacts. FDA will then review the PCCP within the submission to ensure the device’s safety and effectiveness without needing additional marketing submissions for each modification.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “Scientists from the Scripps Research Institute are reporting that it would take just a single mutation in the version of bird flu that has swept through U.S. dairy herds to produce a virus adept at latching on to human cells, a much simpler step than previously imagined.
    • “To date, there have been no documented cases of one human passing avian influenza to another, the Scripps scientists wrote in their paper, which was published Thursday in the journal Science. The mutation they identified would allow the virus to attach to our cells by hitching itself to a protein on their surface, known as the receptor.
    • “William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center who did not participate in the study, called the research “sobering,” adding, “I had not known it would take just one mutation in the virus for it to attach itself to the receptors on human cells.
    • “However, he stressed that the H5N1 virus has been active for 20 years and “has multiplied billions upon billions upon billions of times and the spontaneous mutation that the authors describe,” has not been found, despite intense surveillance.
    • “Yoshihiro Kawaoka, a professor of virology at the University of Wisconsin, who was not involved in the latest research but has studied bird flu extensively, said that statistically, the mutation probably already exists in H5N1-infected cows and humans, given that 1 in 10,000 infectious particles of the influenza virus is a mutant.
    • “James C. Paulson, one of the paper’s authors, and several other top scientists agreed that it is statistically likely the mutation has occurred in the H5N1 virus but stressed that it has yet to be detected, and other barriers remain before the virus could be transmitted from one person to another. Paulson is a professor in the Department of Molecular Medicine at Scripps.”
  • The National Institutes of Health Director, Dr. Monica Bertagnolli, writes in her blog,
    • “Your memories of life experiences are encoded in collections of neurons in the brain that were active at the time the event took place. Later, those same patterns of neural activity are replayed in your mind to help stabilize your memories of past events. But new research suggests those memories aren’t fixed. An NIH-supported study in male mice reveals how an older memory can be “refreshed” and altered by association with newer events.
    • “The findings, reported in Nature , show that a memory of a recent negative event can become linked to the memory of a neutral event that took place days earlier, changing the way it’s remembered. This provides important insight into what we know about how the brain updates and reorganizes memories based on new information. These findings could also have implications for our understanding of neurobiological processes that might occur in the brain in memory-related mental health conditions like post-traumatic stress disorder (PTSD), when people feel stress or fear even in situations that present no danger.” *. * *
    • “Although these findings were obtained in a mouse model, according to the researchers, the study results suggest that our brains may integrate memories to form a cohesive understanding of real-world experiences in ways that offer stability and flexibility. These insights suggest that memories of the past are constantly updated and refreshed by new experiences in ways that may help us function in a world marked by constant change.
    • “The findings also suggest that negative experiences can lead us to fear seemingly unrelated places or events in ways that are detrimental. This may help to explain why for people with PTSD, exposure therapy—in which people work to overcome fears through gradual exposures to them in a safe environment—can stop being effective. The hope is that findings like these might shed light on potential new ways to treat PTSD and related disorders.”
  • Per an NIH press release,
    • “Improvements in cancer prevention and screening have averted more deaths from five cancer types combined over the past 45 years than treatment advances, according to a modeling study led by researchers at the National Institutes of Health (NIH). The study, published Dec. 5, 2024, in JAMA Oncology, looked at deaths from breast, cervical, colorectal, lung, and prostate cancer that were averted by the combination of prevention, screening, and treatment advances. The researchers focused on these five cancers because they are among the most common causes of cancer deaths and strategies exist for their prevention, early detection, and/or treatment. In recent years, these five cancers have made up nearly half of all new cancer diagnoses and deaths.
    • “Although many people may believe that treatment advances are the major driver of reductions in mortality from these five cancers combined, the surprise here is how much prevention and screening contribute to reductions in mortality,” said co-lead investigator Katrina A. B. Goddard, Ph.D., director of NCI’s Division of Cancer Control and Population Sciences. “Eight out of 10 deaths from these five cancers that were averted over the past 45 years were due to advances in prevention and screening.”
    • “A single prevention intervention, smoking cessation, contributed the lion’s share of the deaths averted: 3.45 million from lung cancer alone. When considering each cancer site individually, prevention and screening accounted for most deaths averted for cervical, colorectal, lung, and prostate cancer, whereas treatment advances accounted for most deaths averted from breast cancer.
    • “To reduce cancer death rates, it’s critical that we combine effective strategies in prevention and screening with advances in treatment,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “This study will help us understand which strategies have been most effective in reducing cancer deaths so that we can continue building on this momentum and hopefully increase the use of these strategies across the United States.”
  • The AP adds,
    • “Many moms-to-be opt for blood tests during pregnancy to check for fetal disorders such as Down syndrome. In rare instances, these tests can reveal something unexpected — hints of a hidden cancer in the woman.
    • “In a study of 107 pregnant women whose test results were unusual, 52 were ultimately diagnosed with cancer. Most of them were treated and are now in remission, although seven with advanced cancers died.
    • “They looked like healthy, young women and they reported themselves as being healthy,” said Dr. Diana Bianchi, the senior author of the government study published Wednesday in the New England Journal of Medicine.
    • “Of the discovered cancers, lymphoma blood cancers were the most common, followed by colon and breast cancers.
    • “The blood test is called cell-free DNA sequencing. It looks for fetal problems in DNA fragments shed from the placenta into the mother’s bloodstream. It also can pick up DNA fragments shed by cancer cells.”
  • NBC News relates,
    • “Prescription fills for blockbuster weight loss medications in the U.S. more than doubled in 2024, even with limited insurance coverage and high out-of-pocket costs for the treatments.
    • “That’s according to new data from drug savings company GoodRx, which examined fill trends and spending patterns for weight loss drugs such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.
    • “It offers more evidence of the insatiable demand for a buzzy class of medications called GLP-1 and GIP agonists, which have hefty list prices of roughly $1,000 per month before insurance or savings cards.”
  • More on prevention from Physicians’ Weekly,
    • “People with type 2 diabetes mellitus (T2DM) face a high risk of cardiovascular disease (CVD), but the timing of this elevated risk before diagnosis is not well understood.  
    • “Researchers conducted a retrospective study to examine CVD occurrence up to 30 years before and 5 years after a diagnosis of type 2 diabetes.  
    • ‘They included individuals diagnosed with type 2 diabetes in Denmark (2010 and 2015) n=127,092 and matched comparisons n=381,023. Conditional logistic regression was used to compute ORs for the prevalence of CVD in the 30 years before diagnosis, and Cox proportional hazards regression models to calculate HRs for 5-year CVD incidence after diagnosis.  
    • ‘The results showed that, in the 30 years before diagnosis, 14,179 (11.2%) individuals with type 2 diabetes and 17,871 (4.7%) comparisons experienced CVD. The odds of CVD were higher for individuals with type 2 diabetes, ranging from 2.18 (95% CI: 1.91-2.48) in the earliest period (25-30 years before diagnosis) to 2.96 (95% CI: 2.85-3.08) in the latest period (less than 5 years before diagnosis). After diagnosis, the 5-year CVD incidence was higher for individuals with type 2 diabetes (HR: 2.20; 95% CI: 2.12-2.27).  
    • “They concluded that individuals with type 2 diabetes experienced twice the number of CVD events compared to matched controls, starting up to 30 years before diagnosis, suggesting that early preventive strategies may be necessary.”  

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly said it would invest $3 billion to expand a recently acquired manufacturing facility to meet growing demand for its diabetes and weight-loss medicines.
    • “The drugmaker said the Kenosha County, Wis., plant expansion would extend the reach of its injectable-product manufacturing and add 750 jobs. The facility already employs around 100 people.
    • “Overall, the expanded facility would focus on manufacturing injectable medicines, device assembly and packaging for medicines across multiple therapeutic areas, the Indianapolis company said.
    • “The decision comes months after Lilly resolved shortages for its weight-loss and diabetes drugs, Zepbound and Mounjaro. Lilly’s rival, Novo Nordisk, has been expanding its production capacity to resolve shortages.”
  • Per Fierce Healthcare,
    • “Amazon has added digital musculoskeletal care company Hinge Health to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits.
    • “Hinge Health is the first digital musclosketal platform to join Amazon Health Services’ offering that aims to help people discover and enroll in digital health programs available through their employer or health plan at no additional cost.
    • “It marks the fourth company to join Amazon Health Services’ digital health benefits program, following Omada Health, as its first launch partner, Talkspace and behavioral health company Rula Health.”
  • Per Fierce Pharma,
    • “AstraZeneca has picked off another label expansion for its cancer blockbuster Imfinzi (durvalumab) as the FDA has blessed the PD-L1 inhibitor for limited-stage small cell lung cancer (LS-SCLC) patients who have not had disease progression after concurrent chemotherapy and radiation treatments.
    • “With the nod, Imfinzi becomes the first immunotherapy for LS-SCLC, an aggressive form of the disorder with a survival rate between 15% and 30% after diagnosis. The subtype includes roughly 30% of all SCLC cases. It often recurs and progresses rapidly despite initial response to standard-of-care chemo and radiation treatment.
    • “The approval is backed by results from the ADRIATIC trial which showed that, compared to placebo, Imfinzi extended patients’ lives by 27% among those who had not progressed following chemoradiotherapy. The estimated median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo.”
  • BioPharma Dive points out,
    • “Inside every human cell are thousands of snippets of genetic code that serve as the directions for creating proteins. And over the past four years, a small biotechnology company has been trying to prove that, by looking closely enough at this assembly of instructions, it can find new ways to treat diseases like Alzheimer’s, Parkinson’s and multiple sclerosis.
    • “The company, Muna Therapeutics, now has a nod of confidence from one of the world’s largest drugmakers, as it announced on Thursday a collaboration with GSK that could ultimately be worth hundreds of millions of dollars.
    • “Per deal terms, Muna will analyze brain tissue samples from a variety of sources, from healthy individuals to Alzheimer’s patients to centenarians with and without cognitive impairment. The company will then use different technologies to determine where protein instructions are (or aren’t) in those tissues, with the goal being to identify and validate new targets for Alzheimer’s drugs.”
  • RAND Healthcare shares its key findings on telehealth policy.

Midweek Update

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
The UnitedHealthcare headquarters in Minnetonka, Minn., lowered its flags to half-staff on Wednesday in honor of its CEO. 
PHOTO: KEREM YÜCEL/ASSOCIATED PRESS
  • The Wall Street Journal reports,
    • “UnitedHealth Group’s annual investor day began much like any other corporate event. There was breakfast and then around 8 a.m. Wednesday the collection of investors, executives and Wall Street analysts filed into a capacious third-floor ballroom at the Hilton Hotel in Midtown Manhattan to hear upbeat presentations about the company’s future.
    • “Unbeknown to them, one of the company’s top executives had been killed earlier that morning on the street below in what police say was a targeted attack.
    • “Brian Thompson, chief executive of UnitedHealthcare, the largest U.S. health insurer, had been steps from the Hilton’s entrance at 6:44 a.m. when an assassin wearing a dark hoodie and gray backpack stepped from behind a parked car in the predawn darkness, calmly pursued him for a few steps, and then shot him with a 9-millimeter pistol.
    • “Thompson staggered, appeared to turn toward his pursuer, and then collapsed. The killer fled down an alley and then escaped on a bike, according to police.”
  • The FEHBlog believes the Journal’s description of the killer as an “assassin” is accurate because the press and the medical community have portrayed large health insurers and PBMs as villains. (The term “assassination” usually refers to a politically motivated murder.) This erroneous portrayal stems from the decades long feud between the medical and health insurance communities that the FEHBlog has documented. It is high time for the feud to be resolved. RIP Mr. Thomson.

From Washington, DC,

  • The AP tells us that all of the House of Representatives elections have been called, and the final 2025 split is 220 Republicans and 215 Democrats.
  • STAT News reports,
    • “Negotiations over a large health care policy package are heating up this week as Congress hurtles toward a government funding deadline at the end of the month.
    • “Congressional Republicans on Tuesday made an offer to Democrats that included a three-year extension of pandemic-era telehealth flexibilities in Medicare, some reforms in how pharmacy middlemen operate, a Medicare pay bump for doctors, funding for community health centers, and extensions of public health programs in Medicare and Medicaid, according to a copy obtained by STAT. 
    • “However, Republicans proposed paying for the policies with a full repeal of the Biden administration’s controversial nursing home staffing rule, which sets minimum staffing requirements. Repealing the rule would have saved the federal government $22 billion. Democrats are unwilling to repeal their own administration’s policy, so the offer is a no-go, five sources familiar with the talks told STAT. 
    • “Negotiations are ongoing.” 
  • and
    • “In an unexpected move, the U.S. Patent & Trademark Office has withdrawn a controversial proposal that was designed to prevent pharmaceutical companies from abusing the patent system.
    • “Specifically, the proposed rule was crafted to stem the use of so-called patent thickets, which are wielded by drug companies to delay the arrival of lower-cost generic medicines in the marketplace. Essentially, thickets are collections of numerous patents that critics contend add only incremental changes to a drug and, therefore, produce little to no additional benefit to patients.
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services Dec. 4 announced that drug manufacturers bluebird bio, inc. (manufacturer of Lyfgenia) and Vertex Pharmaceuticals (manufacturer of Casgevy) will participate in its Cell and Gene Therapy Access Model. [Both of the drugs are “Food and Drug Administration-approved gene therapies for sickle cell disease.]
    • “The voluntary model will test whether a CMS-led approach to developing and administering outcomes-based agreements for cell and gene therapies improves Medicaid beneficiaries’ health outcomes, broadens access to innovative treatment and reduces health care expenditures. The CGT Access Model launches in January, and states can choose to begin participation anytime between then and January 2026. The state application portal will also go live this month and remain open through Feb. 28, 2025. In addition, states may apply for optional model funding by Feb. 28, 2025, through the notice of funding opportunity.”
  • Kevin Moss, writing in Govexec, offers last minute advice for Federal Employee Benefits Open Season which ends December 9.

From the public health and medical research front,

  • During the Covid pandemic the FEHBlog’s go to columnist was David Leonhardt from the New York Times. This morning, Mr. Leonhardt wrote about the bird flu.
    • Caitlin “Rivers, the Johns Hopkins epidemiologist, recently published a book on preventing outbreaks called “Crisis Averted.” In it, she argues that one of the most effective public health strategies is honesty: Experts should level with people, rather than telling selective truths intended to shape behavior in paternalistic ways (as happened during Covid).
    • “When I spoke with Rivers this week, I asked for some truth telling about bird flu. “As an epidemiologist, I’m worried,” she said. “I’m not worried as a mom or a member of my community. It’s not a threat that is imminent.”
    • “But H5N1 bears watching. It is changing and spreading in uncertain ways, and it already presents a threat to many animals and to people who work closely with them.”
  • Well put.
  • BioPharma Dive informs us,
    • “Zepbound, an in-demand weight loss drug from Eli Lilly, helped people in a large clinical trial lose significantly more weight over 18 months than Novo Nordisk’s rival treatment Wegovy, results released by Lilly Wednesday show.
    • “The head-to-head results are a key finding that may help Lilly wrest greater share of a pharmaceutical drug market that’s forecast to eventually exceed $100 billion in annual sales. For that reason, Lilly’s study, called SURMOUNT-5, has long been circled by investors and analysts on Wall Street as one of the year’s most important drug studies.
    • “Lilly only disclosed summary data in its Wednesday statement, indicating it will share fuller findings at a medical meeting next year. According to the results Lilly made available, trial volunteers with obesity or who were overweight with related health problems lost an average of 20.2% of their bodyweight from taking Zepbound, significantly more than those who received Wegovy, who lost 13.7% on average. That translated to an average of 50 pounds lost among Zepbound-treated participants, versus 33 pounds for those on Wegovy.
    • “Nearly one-third of people given Zepbound experienced weight loss of 25% or more, compared to 16% in the Wegovy group, Lilly said.
    • “For both drugs, the most common side effects were gastrointestinal and, according to Lilly, generally mild to moderate in severity. Side effects are being closely watched, as commercial use of Zepbound and Wegovy has shown many people taking them later discontinue treatment.”
  • Gallup lets us know,
    • “Fifty-one percent of working women in the U.S. report feeling stressed a lot of the day yesterday (vs. 39% of men). Additionally, 42% of working women say their job has had a somewhat or extremely negative impact on their mental health over the last six months (vs. 37% of men). The consequential ripples of women’s wellbeing affect organizations as declines in wellbeing are associated with lower engagement, higher burnout and increased participation in job-seeking behaviors.” * * *
    • “Programs and managers alone cannot make progress if employees do not feel that their organization has a strong culture of wellbeing. If employees doubt leadership’s commitment to wellbeing initiatives or worry about negative repercussions for accessing them, they may avoid engaging with these offerings. This avoidance can lead to resources being overlooked and employee needs remaining unmet, ultimately affecting the company’s bottom line. Building a culture of wellbeing starts with leaders demonstrating desired behaviors, fostering open communication about the importance of wellbeing, actively highlighting available resources, and making the employee experience a central focus of their organizational strategy.”
  • The Washington Post relates,
    • “Splash pads found in public parks across the United States are linked to thousands of cases of waterborne diseases that leave a calling card of diarrhea, fever and vomiting, the Centers for Disease Control and Prevention reported this week.
    • “More than 10,000 children became ill from 1997 to 2022 after using splash pads, and most of those outbreaks were attributed to cryptosporidium, a parasite that causes diarrhea and spreads through contaminated water.
    • “No deaths were blamed on the infections, but the CDC said families need to be more vigilant about the proper use of splash pads. The agency also encouraged parents to avoid using public aquatic centers if their children have diarrhea.”
  • Per MedPage Today,
    • “Blocking blood flow to the site of knee arthritis can reduce pain and potentially prevent the need for knee replacement surgery, a new study says.
    • “The procedure, called genicular artery embolization (GAE), improved patients’ quality of life by 87% and their pain by 71% at a one-year follow-up, researchers report.
    • “Our study found that GAE can effectively reduce knee pain and improve quality of life early after the treatment, with these benefits being maintained over the long term, especially for people who haven’t had success with other treatments like physical therapy or pain medications,” said lead researcher Dr. Florian Nima Fleckenstein, an interventional radiologist at Charité – University Hospital Berlin in Germany.”
  • and
    • “Traces of nine essential metals and non-essential metals in urine were linked with lower cognitive performance and the risk of future dementia, a large prospective study showed.
    • “The study assessed concentrations of the essential metals cobalt, copper, manganese, and zinc, and the non-essential metals arsenic, cadmium, lead, tungsten, and uranium.
    • “Comparing the top and bottom percentiles of exposure to all nine metals, the hazard ratio of dementia was 1.71 (95% CI 1.24-3.89), reported Arce Domingo-Relloso, PhD, of the Columbia University Mailman School of Public Health in New York City, in JAMA Network Open.” * * *
    • “Identifying modifiable risk factors and groups at higher risk for Alzheimer’s and dementia is crucial, Domingo-Relloso observed.
    • “This study not only shows that exposure to metals is associated with cognitive decline, but more importantly, carrying at least one copy of the APOE4 allele could modify this association, which opens the door to the creation of early risk assessment tools based on individuals’ genetic and environmental exposure profiles,” she told MedPage Today.“

From the U.S. healthcare business front,

  • The New York Times reports
    • “Over 500 hospitals have closed their labor and delivery departments since 2010, according to a large new study, leaving most rural hospitals and more than a third of urban hospitals without obstetric care.
    • “Those closures, the study found, were slightly offset by the opening of new units in about 130 hospitals. Even so, the share of hospitals without maternity wards increased every year, according to the study, published on Wednesday in JAMA, a prominent medical journal. Maternal deaths remained persistently high over that period, spiking during the pandemic.”
  • Modern Healthcare lets us know,
    • “The largest pharmacy benefit managers are heralding an era of transparency, and the demand for these new models may suggest their traditional spread pricing approach will fade.
    • “Amid growing complaints and evolving market dynamics, CVS Health subsidiary CVS Caremark, UnitedHealth Group unit OptumRx and Cigna division Express Scripts — which together control nearly 60% of the market, according to the American Medical Association — are pitching customers “transparent” PBM services that promise more flexible designs, more predictable pricing and, potentially, lower costs.
    • “It’s our responsibility to continue to drive and reshape the way drug pricing is in this country. Make it more transparent to make it easier to understand,” said Prem Shah, group president of CVS Health who oversees its pharmacy and PBM divisions. “This is our step and our movement to do exactly that.”
    • “These transparent PBM alternatives emerged as clients demand greater insight into how their money is spent. At the same time, lawmakers have grilled PBM executives and regulators continue investigating their business practices.”
  • Per Fierce Healthcare,
    • “CVS Health has announced further leadership appointments as the healthcare giant navigates choppy financial waters.
    • “Len Shankman will step into the role of president for pharmacy and consumer wellness, CVS announced. Shankman, who has risen up the ranks of CVS’ pharmacy division since 2002, will lead strategy for the company’s retail pharmacies and stores. * * *
    • “In addition to Shankman’s appointment, CVS revealed that Lucille Accetta has been tapped as its chief pharmacy officer. In this position, she’ll lead the charge in advocating for the role of the pharmacist and in finding ways to leverage their expertise across CVS’ enterprise.”
  • The AP relates,
    • “Nearly three out of 10 U.S. drugstores that were open during the previous decade had closed by 2021, new research shows.
    • “Black and Latino neighborhoods were most vulnerable to the retail pharmacy closures, which can chip away at already-limited care options in those communities, researchers said in a study published Tuesday in Health Affairs.
    • “The trend has potentially gained momentum since the study’s timeframe, because many drugstores are still struggling. In the last three years, the major chains Walgreens and CVS have closed hundreds of additional stores, and Rite Aid shrank as it went through a bankruptcy reorganization.
    • “Drugstores have been dealing with shrinking reimbursement for prescriptions, rising costs and changing customer shopping habits. The chains have been closing money-losing stores and transferring prescription files to more profitable locations.” * * *
    • “The study found that more than 29% of the nearly 89,000 retail U.S. pharmacies that operated between 2010 and 2020 had closed by 2021. That amounts to more than 26,000 stores.
    • “Researchers using data from the National Council for Prescription Drug Programs found that the number of U.S. pharmacies had actually increased from 2010 to 2017 because of store openings, but the pace of closings picked up starting in 2018.”

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.”

Weekend Update

David Ermer–Congress, Federal employment benefits, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The deadline for Congress to take action on Fiscal Year 2025 appropriations is Friday December 20.
  • FedWeek lets us know,
    • “Rep. James Comer, R-Ky., is due to remain chairman of the Oversight and Accountability Committee for the 2025-2026 Congress.” * * *
    • “On the Senate side, another Kentucky Republican, Sen. Rand Paul, is set to become chairman of the Homeland Security and Governmental Affairs when the GOP takes control of that chamber.” * * *
    • “There has been no indication of a nominee for OPM director, but one potential candidate would be Michael Rigas, who was deputy director late in the first term and then acting director from March 2020 when the second of the directors confirmed in that administration resigned after disputes over the White House’s intent to move OPM’s policy functions directly under OMB. Rigas was not then nominated to become director, however.”
  • The Medicare open enrollment period ends this Saturday December 7, while the Federal Employees Benefits Open Season is scheduled to end the following Monday, December 9. It remains to be seen whether OPM will extend the first open season for the Postal Service Health Benefits Program as some have urged.
  • The FEHBlog urges OPM and PSHBP carriers to share with Postal Service annuitants over age 65 the substance of this Washington Post article about “How to take advantage of Medicare’s expanded drug benefit in 2025. “It will be easier to spread out Part D drug costs over the year, while the total annual cost of medicines will be capped at $2,000.” The new Medicare Part D features make Part D a viable alternative to folks who currently rely on manufacturer coupons.
  • The U.S. Attorney’s Office for the Southern District of Texas announced last Wednesday,
    • “A 53-year-old Sugar Land [Texas] man has agreed to pay $2,095,946 to resolve allegations he submitted false claims for the placement of electro-acupuncture devices, announced U.S. Attorney Alamdar S. Hamdani.
    • “Dr. Rajesh Bindal used the entity Texas Spine & Neurosurgery Center P.A. to conduct his medical practice. From March 16, 2021, to April 22, 2022, Bindal billed Medicare and the Federal Employees Health Benefits Program (FEHBP) for the surgical implantation of neurostimulator electrodes. 
    • “These are invasive procedures usually requiring use of an operating room. As a result, Medicare and the FEHBP pay thousands of dollars per procedure. 
    • “However, neither Bindal nor his staff performed these surgical procedures, according to the allegations. 
    • “Instead, patients allegedly received devices used for electro-acupuncture, which only involved inserting monofilament wire a few millimeters into patients’ ears and taping the device behind the ear with an adhesive. In some instances, a device sales representative or a physician assistant allegedly performed these placements, which were then billed as surgeries. All device placements took place in Bindal’s clinic, not a hospital or surgical center, and no incision was made on a patient. Most patients claimed the adhesive came loose and the device fell off on its own accord within a few days.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Many of the manufacturing jobs that are being moved overseas, replaced by automation or phased out of the American economy were mostly filled by men. As a result, other occupations traditionally dominated by women are now gaining a larger share of men, including elementary and middle-school teachers and customer-service representatives. 
    • “Still, nursing is a relative outperformer in the proportion of men joining what has long been considered a “pink collar” sector. The number of male registered nurses has increased from about 140,000 in 2000 to about 400,000 in 2023. This means that about 14% of nurses are now men, up from about 9% roughly two decades ago. 
    • “Economists at the Washington Center for Equitable Growth found that men who were becoming registered nurses tended to do so in their late 20s or early 30s rather than as their first job.”
  • and
    • “The obesity duopoly has been pierced as Amgen positions itself to have a drug on the market in a few years. While this adds competition to a market currently controlled by Eli Lilly and Novo Nordisk, it also reinforces the dominance of the makers of Wegovy and Zepbound.
    • “Amgen reported on Tuesday that its highly anticipated obesity-drug candidate, MariTide, helped patients shed around 20% of their body weight, though side effects such as nausea and vomiting were common. The company didn’t disclose detailed data, which is expected at a medical conference next year. If all goes well in a larger late-stage study, Amgen could have a drug on the market within a few years. 
    • “But what we already know suggests that Lilly and Novo Nordisk’s market leadership isn’t about to be upended. Not only did MariTide fail to outperform Lilly’s Zepbound, but both Lilly and Novo also have next-generation medications under development, with promising data showing even more impressive weight loss results.”
  • HR Dive tells us
    • “What employers should know now that the 2024 [Fair Labor Standards Act] overtime rule is vacated.
    • “One attorney cautioned against dropping workers’ recently changed nonexempt status too quickly or without careful consideration.”

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.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “In a flurry of Friday night announcements, President-elect Donald Trump said he had selected Scott Bessent, a financier who embraced MAGA, to head the Treasury Department; Russell Vought, a Project 2025 contributor, to run the White House budget office again; and Rep. Lori Chavez-DeRemer (R-Oregon) [who lost her bid for re-election] for labor secretary. The president-elect also said he had selected Janette Nesheiwat, a Fox News contributor, to serve as surgeon general; and former congressman Dave Weldon to head the Centers for Disease Control and Prevention.”
  • The HHS, Labor, and Treasury Secretaries are the principal Affordable Care Act regulators while the Office for Management and Budget carriers a lot of weight with the Office of Personnel Mangement.
  • The American Hospital Association News tells us,
    • “The AHA and 22 other organizations Nov. 22 urged Congress to pass an end-of-year health care package that includes action on alternative payment models and a scheduled physician payment cut. The organizations requested an extension of Medicare’s Advanced Alternative Payment Model incentive payments, ensure that APM qualifying thresholds remain attainable and replacement of a scheduled cut to Medicare physician payments with an update reflective of inflationary pressures.
    • “These payment reforms have generated more than $28 billion in gross savings for Medicare over the past decade,” the organizations wrote. “The Centers for Medicare & Medicaid Services (CMS) recently released results showing that the Medicare Shared Savings Program and [Accountable Care Organization] REACH Model, the largest APMs in Medicare, generated $2.8 billion in net savings for the Medicare program in 2023, while improving patient access and quality.”  
  • HHS’s HRSA shares information on federal government spending to improve rural healthcare.
  • Per MedTech Dive,
    • “The Food and Drug Administration’s medical device center unveiled Thursday a pilot program meant to speed up notices to the public about potentially high-risk product recalls.
    • “The pilot aims to improve the time between when the FDA first knows about certain corrective actions on products and when the public and healthcare providers are notified. The actions include when companies remove products from the market, correct products or update use instructions due to potentially high safety risks.
    • “The program will provide “early alerts” of potentially high-risk device removals or corrections related to cardiovascular, gastro renal, general hospital, obstetrics and gynecology and urology, according to the FDA’s Center for Devices and Radiological Health. The center added, “At this time, there is no change to any other recall process or recall communication timelines for other areas.”
    • “Michelle Tarver, the new CDRH director, said in a statement that the program is meant to increase transparency.”
  • Kevin Moss writing in Federal News Network offers an Open Season checklist for federal employees while FedWeek shares “11 FAQs: Open Season & PSHB/FEHB Switchover.”

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. Seasonal influenza activity remains low nationally. RSV activity is elevated and continues to increase in the southern, central, and eastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae remain elevated among 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. COVID-19 activity is low with no meaningful changes in infection levels predicted.
      • “CDC expects that the 2024-2025 COVID-19 vaccine will 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
      • “RSV activity is elevated and continues to increase in the southern and eastern United States. Activity is low in the rest of the country but increasing in the central and western United States. Emergency department visits and hospitalization rates are increasing in young children in the southern, central, and eastern United States.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections afforded by vaccines.”
  • The University of Minnesota’s CIDRAP tells us,
    • “The US Centers for Disease Control and Prevention (CDC) said today that its tests have confirmed H5N1 avian flu in California’s recent suspected case, involving a child who had no known exposure to infected animals.
    • “Also, California announced another confirmed H5 case in a dairy farm worker. The new developments lift the state’s total to 29 human cases of H5 avian flu and the national total since the first of the year to 55.” * * *
    • “The child is recovering, and all family members tested negative for H5 avian influenza but positive for the same common respiratory virus as the child. Contact tracing continues, and there is no sign of human-to-human spread.
    • “Investigation into the child’s exposure to H5N1 is still under way, the CDC said.”
  • The New York Times reports,
    • “The number of deaths caused by alcohol-related diseases more than doubled among Americans between 1999 and 2020, according to new research. Alcohol was involved in nearly 50,000 deaths among adults ages 25 to 85 in 2020, up from just under 20,000 in 1999.
    • “The increases were in all age groups. The biggest spike was observed among adults ages 25 to 34, whose fatality rate increased nearly fourfold between 1999 and 2020.
    • “Women are still far less likely than men to die of an illness caused by alcohol, but they also experienced a steep surge, with rates rising 2.5-fold over 20 years.
    • “The new study, published in The American Journal of Medicine, drew on data from the Centers for Disease Control and Prevention.”
  • A Wall Street Journal reporter observes
    • “After years of pushing the benign myth that a glass of wine a day is good for the heart, it seems the medical establishment has abandoned hedonists and pleasure seekers. Is there a safe amount of alcohol? It turns out no. 
    • “For this and other more amorphous reasons, I have noticed increasing numbers of people around me are sober-ish. They drink only socially or only two glasses of wine a week or only in restaurants. They are not willing to give up drinking entirely, which feels like too vast and depressing a surrender of life’s pleasures. So they make rules for themselves. 
    • “Someone I know has a new ritual of drinking a nonalcoholic beer with nuts on her terrace. Another friend told me that she used to drop by for drinks at friends’ houses in the evenings, and now it is just as often tea.”
  • Medscape discusses the side effects of GLP-1 drugs.
    • “Just a few years after some TikTok videos spiked the demand, one in eight US adults has tried Ozempic (semaglutide) or another drug in its class. Glucagon-like peptide 1 (GLP-1) receptor agonist medications have revolutionized obesity medicine.
    • “But they’re not without problems. In the early days of the social media craze, news reports often featured patients whose gastrointestinal side effects sent them to the emergency room (ER).
    • “It happened a lot then. Patients didn’t want to complain because they were losing weight, and they wound up in the ER with extreme constipation or a small bowel obstruction,” said Caroline Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.
    • “But that’s not really happening now,” she added.
    • “Research backs up her assertion: A recent clinical review of studies found that many patients still experience side effects, but only at a mild to moderate level, while the dosage increases — and the unpleasantness tapers with time. Roughly 7% of patients discontinue the medications due to these symptoms.”
  • KFF provides findings from its 2024 Women’s Health Survey concerning contraception.
  • Medical Economics informs us,
    • “More than one in five U.S. adults, which equates to 59.3 million people, were living with mental illnesses in 2022, yet just more than half of them (50.6%) had received treatment in the previous year. A new study, from West Health and Gallup, uncovered that 70% of Americans would prefer to be asked about both their physical health and their mental health during appointments with their primary care providers (PCPs).
    • ‘The West Health-Gallup Survey on Mental Health in America reported that 65% of men and 76% of women hoped to discuss both physical and mental health with their PCPs. The survey also found that 66% of U.S. adults have been asked about their mental health by their PCPs or family practitioners, whereas 32% of adults said that had never happened. Women were more likely than men (71% compared to 60%) to be asked about mental health.”
  • The University of Minnesota’s CIDRAP lets us know,
    • “Yesterday, the US Centers for Disease Control and Prevention (CDC) closed its investigation into the multistate Listeria outbreak tied to Boar’s Head deli meat after 61 cases and 10 deaths were reported.”
  • The Food and Drug Administration announced,
    • “On Thursday, the FDA updated the outbreak advisory for E. coli O21:H19 infections linked to organic whole and baby carrots supplied by Grimmway Farms. The retail-packaged organic whole carrots were in stores for purchase from August 14 through October 23, 2024. The organic baby carrots have different best-if-used-by-dates ranging from September 11 through November 12, 2024. The update includes information about recalled product being distributed to markets outside the United States and additional recalls from companies that may have used or repackaged recalled carrots from Grimmway Farms. FDA’s investigation remains ongoing.”
  • The Washington Post reports,
    • “The Detroit-based Wolverine Packing Co. recalled more than 167,000 pounds of ground beef products because of concerns that the meat may be contaminated with E. coli, according to the U.S. Department of Agriculture. The recall affects fresh products that have a use-by date of Nov. 14 and frozen products whose labels contain a production date of Oct. 22, officials said.
    • “On Nov. 13, Minnesota’s Department of Agriculture alerted the Food Safety and Inspection Service, an agency of the USDA, about a group of people who had consumed ground beef before they fell ill.
    • ‘On Nov. 20, a ground beef sample collected by Minnesota officials tested positive for E. coli O157. Federal officials determined that the products from Wolverine Packing Co. were linked to the people who had become sickened in Minnesota.
    • “At least 15 patients have been identified, and the onset of their infections range from Nov. 2 to Nov. 10, the USDA said. At least two have been hospitalized, according to Minnesota officials.
    • “The recalled products have the establishment number EST. 2574B inside the USDA mark of inspection. The items were shipped to restaurant locations nationwide, according to officials.
    • Some products may be in restaurant refrigerators or freezers, officials said.
    • “Restaurants are urged not to serve these products.”

From the U.S. healthcare business front,

  • HR Dive relates,
    • “Insurers are projecting medical costs will increase globally in 2025 — by about 10.4%, according to WTW’s 2025 Global Medical Trends Survey.
    • “Specifically in the U.S., insurers project a 10.2% increase in 2025, up from 9.3% this year.
    • “Notably, WTW researchers said that public healthcare systems worldwide have been overwhelmed due to high demand and low resources, which has led to people turning to private providers.”
  • Health Leaders Media discusses an Oschner Health program with myLaurel which offers value-based medical care at home.
    • “Billing arrangements are a key difference between CMS’ Acute Hospital Care at Home program and Ochsner Health’s Acute Care at Home program.
    • “The Acute Care at Home program features virtual visits with physicians, nurses, and care managers as well as in-person visits with paramedics.
    • “By reducing hospital admissions and readmissions, the Acute Care at Home program is decreasing total cost of care.”
  • Investment News reports,
    • “Despite the benefits of health savings accounts as tax-advantaged retirement savings tools, employees are largely using them to meet current healthcare expenses, according to a new survey by the Plan Sponsor Council of America.
    • “The 2024 HSA Survey, sponsored by HSA Bank, reflects responses from more than 500 employers and shows modest growth in account balances and contributions. However, it also highlights a need for greater education around the long-term benefits of HSAs.
    • “While 90 percent of eligible employees had an HSA in 2023 and three-quarters made contributions, few are leveraging them for retirement planning.
    • “Among other key insights, the survey found that only one-third of employers educate workers about using HSAs as part of their retirement strategies, and fewer than 30 percent allow participants to view their HSA balances alongside retirement accounts for a more holistic view of savings. Less than 10 percent of employers mirror HSA investment options with those available in their 401(k) plans, though interest in doing so has grown.”
  • The Wall Street Journal reports,
    • “An industry fight against lucrative drug discounts for hospitals is intensifying as another drugmaker joins the battle: Sanofi.
    • “The pharmaceutical company plans to change its policy on how it gives discounts to certain hospitals. Sanofi will require institutions to provide pharmacy and medical claims information before receiving federally mandated discounts. The company sent a letter, which was viewed by The Wall Street Journal, to hospitals outlining its new model on Friday, according to people familiar with the matter. 
    • “The French company’s plan, which would take effect early next year, comes as the industry escalates its efforts to rein in the federal program known as 340B. Eli Lilly and Johnson & Johnson this month filed separate lawsuits against the federal government for rejecting the companies’ plans to tighten the way they provide the discounts to hospitals in the program.” 
  • Per BioPharma Dive,
    • “Medtronic received Food and Drug Administration clearance for its new InPen smart insulin pen app that can recommend corrections for missed or inaccurate insulin doses at mealtime.
    • “The authorization paves the way for the launch of Medtronic’s Smart MDI system, which combines InPen with the Simplera continuous glucose monitor (CGM), the company said Wednesday. 
    • “With the clearance, Medtronic said Smart MDI will be the first system on the market to provide personalized insights on when and how much insulin to dose in real-time for people who take multiple daily injections.”

Midweek Update

David Ermer–AHRQ, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare, Uncategorized–
Photo by Tomasz Filipek on Unsplash

From Washington, DC

  • This afternoon the FEHBlog was listening to an OPM meeting about the PSHBP when someone mentioned a benefit administration letter. The FEHBlog realized that he was overdue in posting the 2025 FEHB and PSHBP Significant Plan Changes notices which appear under on OPM’s benefit administration letters page.
  • Kevin Moss, writing in Govexec, pitches the many advantages available to annuitants over age 65 who enroll in an FEHB or PSHB plan’s Medicare Part D EGWP for 2025. Mr. Moss warns readers about the income adjusted Part D premiums (IRMAA) and the Medicare bar against using manufacturer coupons. In the FEHBlog’s opinion, the combination of the Medicare Part D’s new features for 2025 — a $2000 out of pocket maximum and the Medicare Prescription Payment Plan — outclass manufacturer coupons and diminish the impact of IRMAA which in any case is much lower for Part D compared to Part B.
  • HUB International reminds us,
    • “Back in 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act first allowed HDHPs to cover telehealth and other remote care services on a first dollar basis through the end of 2021. This was initially designed to make medical care accessible during the COVID-19 pandemic, when it may not have been for many in need.
    • “Congress first resurrected this relief in April 2022 after a three-month hiatus. This relief was scheduled to end on December 31, 2022, until Congress extended it once again. This second extension is now coming to an end for plan years beginning on or after January 1, 2025.”
  • The lame duck session of Congress could pass a law extending this benefit beyond 2024.
  • The U.S. Preventive Services Taskforce presented its 14th annual report to Congress on “High-Priority Evidence Gaps Across the Lifespan, in All Communities” today.

From the public health and medical research front,

  • MedPage Today tells us,
    • “Among adults with outpatient respiratory syncytial virus (RSV) infections across six RSV seasons, roughly one in 20 were hospitalized within 28 days, according to a large cohort study that used data from three health record databases.
    • “In the cohort of over 67,000 patients with outpatient medically attended RSV infections, hospitalization rates were 4.5% to 6.2%, and 6.5% to 8.5% in a high-risk subgroup, across the three databases, reported Joshua T. Swan, PharmD, MPH, of Pfizer in New York City, and colleagues in JAMA Network Open.
    • “High-risk features included age 65 and older, asthma, chronic obstructive pulmonary disease (COPD), and congestive heart failure (CHF). Across the patients in the three databases, comorbidity prevalence were 20% to 30.5% for COPD, 14.6% to 24.4% for CHF, 14.6% to 24.4% for asthma, and 14% to 54.5% for age 65 and over.
    • “Infection rates for RSV have been underestimated, partly due to underutilization of testing for the viruses, Swan and team noted. Although there are three available vaccines against RSV, there are few approved treatments for it.”
  • and
    • “Diagnoses of postpartum depression (PPD) increased significantly across all racial and ethnic groups and prepregnancy body mass index (BMI) categories over the past decade, according to a California-based cross-sectional study.
    • “An analysis of more than 400,000 pregnancies found that prevalence of PPD doubled from 2010 to 2021 (9.4% vs 19%), according to Darios Getahun, MD, PhD, MPH, of Kaiser Permanente Southern California in Pasadena, and co-authors.
    • “While rates increased across all groups, the largest increases were seen in those who identified as Asian and Pacific Islander (280% increase) and non-Hispanic Black (140% increase), they reported in JAMA Network Open.”
  • The National Cancer Institute released cancer information highlights about “B-Cell Lymphoma | Advanced Cancer | Skin Cancer and Darker Skin.”
  • Per Fierce Pharma,
    • “It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. Now with a new nod in hidradenitis suppurativa (HS), the drug seems to be carving the path to blockbuster land with five approved indications.
    • “Bimzelx, which is the first to selectively inhibit IL-17F as well as IL-17A, was cleared to treat adults with moderate to severe forms of the disease after proving it could help patients significantly reduce signs and symptoms of the condition. HS is characterized by chronic and recurring painful nodules, abscesses and pus-discharging fistulas that can have a major impact on quality of life.
    • “UCB is “thrilled” with the milestone, head of patient impact and chief commercial officer Emmanuel Caeymaex said in a company press release.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds.
    • “Many healthcare organizations are moving past early pilot successes to enterprise scaled solutions, but are balancing AI enthusiasm against pragmatism, according to the survey from Define Ventures of C-suite and senior executive leaders from more than 60 providers and payers.
    • “Define Ventures, a venture capital firm focused on early-stage health tech companies, conducted surveys and meetings with executives from 10 of the top 20 providers and three of the top 10 payers to check the industry’s pulse on AI adoption and investment. The survey took place from August through early November.”
  • Per BioPharma Dive,
    • “Pfizer on Wednesday said it will promote Chris Boshoff to chief scientific officer and president of research and development as the giant drugmaker struggles to win back the faith of investors.
    • “Boshoff will assume his new post on Jan. 1, succeeding Mikael Dolsten, who oversaw research at Pfizer for 15 years. The company announced Dolsten’s departure in July.
    • “Boshoff currently serves as chief oncology officer and is credited with delivering 24 approved new medicines and biosimilars during his 11-year tenure at the company. Boshoff has also worked as Pfizer’s head of development in Japan and as chief development officer for oncology and rare disease.”
  • Kauffman Hall discusses the misadventures of primary care.
  • Modern Healthcare reports,
    • “Three lawsuits filed against data analytics firm MultiPlan alleging antitrust law violations for reducing pay for out-of-network providers have been consolidated into one suit seeking class action status.
    • “The American Medical Association and the Illinois State Medical Society filed suit against the company in October in federal court in Illinois. Advanced Orthopedic Center, a medical practice in Poway, California filed its suit in June in federal court in New York. Orthopedic provider Dr. Curtis Robinson filed his suit in federal court in California.
    • “The complaints, all now in the U.S. District Court for the Northern District of Illinois, allege MultiPlan has contracts with 700 large insurers, which allows them to have unfair control of market rates for provider pay.” * * *
    • “A spokesperson for MultiPlan said the company intends to fight the allegations.