Thursday Report

FDA

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%.”

Midweek Update

David Ermer–ACA, CDC, Congress, Electronic health records, FDA, Medical / Rx research, NIH, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reported this morning
    • “A bipartisan group of lawmakers introduced legislation to break up pharmacy-benefit managers, the drug middlemen that have now faced yearslong scrutiny from Congress and the Federal Trade Commission.
    • “A Senate bill, sponsored by Sens. Elizabeth Warren (D., Mass.) and Josh Hawley (R., Mo.), would force the companies that own health insurers or pharmacy-benefit managers to divest their pharmacy businesses within three years.
    • “A companion bill, which sponsors say draws on a history of government prohibitions on joint ownership within industries, was also introduced in the House on Wednesday.
    • “If passed, the legislation would be the most far-reaching intervention yet into the operations of pharmacy-benefit managers, known as PBMs, and their parent companies, cutting off a major source of revenue for the companies and frustration for patients.”
  • STAT News added this afternoon,
    • “A proposed Senate bill that would prohibit companies that control health insurers or pharmacy benefit managers from owning pharmacies rattled investors on Wednesday, but some Wall Street analysts believe the legislation is unlikely to gain much traction, at least for now.
    • “The bipartisan bill, which would require divestiture within three years, is aimed at what the lawmakers call an “inherent conflict of interest” that has forced Americans to pay more for medicines and hastened the demise of independent pharmacies. A companion bill, that refers to a history of government prohibitions on joint ownership within industries, is scheduled to be introduced in the House.” * * *
    • Wall Street watchers believe the lower stock prices are an overreaction. Although the insurers are a juicy target, various factors suggest the bill is far from a sure bet, given the upcoming change in administrations. Securities analysts believe other legislative priorities will get more attention, despite a focus on health care matters more broadly.”
  • The Wall Street Journal also lets us know,
    • “The House voted Wednesday to approve a nearly $900 billion annual defense policy bill that includes a controversial provision that would block some transgender medical care for minors covered by the military’s healthcare program.
    • “The package, which sets national defense standards and priorities for the 2025 fiscal year, notably calls for a 14.5% pay raise for junior enlisted service members, dwarfing the 4.5% pay raise included for all other members of the armed forces. The package passed 281-140, with most Republicans voting for the bill but more than half of Democrats voting no.
    • “The 1,800-page National Defense Authorization Act would increase the national security budget to $895 billion, about a 1% increase from last year’s total, less than inflation. * * *
    • “The NDAA authorizes appropriations but doesn’t provide budget authority, making it a guide to what military spending is ultimately passed separately by Congress. It is set to be the 64th consecutive NDAA successfully passed through Congress—a rarity in what has increasingly become a divided and chaotic legislature. 
    • “The bill is now expected to be fast-tracked in the Senate, where the chamber will likely pass it before Congress leaves at the end of next week. From there, it would go to President Biden’s desk, where he is expected to sign it.”
  • Federal News Network tells us,
    • “With just a few weeks left in the year for President Joe Biden to finalize the 2025 federal pay raise, House and Senate Democrats are calling for a larger pay boost than the currently planned raise for civilian federal employees on the General Schedule.
    • “In a letter sent to Biden Wednesday morning, a group of 22 Democrats pushed for what they said should be “pay parity” between civilian and military federal employees. Currently, civilian and military personnel are slated for likely different pay raises for 2025.
    • “We believe it is imperative you revise your budget to align military and civilian employee pay raises,” the lawmakers, led by Sens. Tim Kaine (D-Va.) and Mark Warner (D-Va.), and Rep. Steny Hoyer (D-Md.), wrote in the letter, shared with Federal News Network.
    • “Currently, most civilian employees are on track to receive a 2% federal pay raise beginning in January, according to the alternative pay plan Biden sent to congressional leaders in August. In contrast, military personnel are expected to likely receive a 4.5% raise for 2025. Although the raise amounts appear to be heading in those two directions, neither raise amount is final just yet. Unless Congress or Biden opts for a different pay plan, the 2% raise is expected to become final through signing an executive order by the end of December.”
  • The American Hospital Association News informs us,
    • The Senate Dec. 10 unanimously passed legislation reauthorizing the Emergency Medical Services for Children Program (H.R. 6960) for an additional five years. The program provides funding for equipment and training to help hospitals and paramedics treat pediatric emergencies. The program was authorized at $24.3 million per year from 2025-2029. The bill was passed by the House in May.”
  • and
    • “The Department of Health and Human Services Dec. 11 published a final rule implementing provisions related to the Trusted Exchange Framework and Common Agreement. The rule is intended to advance equity, innovation and interoperability by promoting the use and exchange of electronically captured health information as specified in certain provisions of the Health Information Technology for Economic and Clinical Health Act of 2009.  
    • “The provisions today’s final rule adopts were first proposed in August as part of a much larger rule and will be effective 30 days after it is officially published in the Federal Register.”
  • The New York Times relates,
    • “In the final days of the Biden administration, the Food and Drug Administration is seeking White House approval to propose a drastic reduction in the amount of nicotine in cigarettes, a longstanding goal of public health experts that has faced stiff opposition from the powerful tobacco lobby.
    • “The F.D.A. submitted the proposal to the Office of Management and Budget only on Tuesday, a sign that the move was perhaps more wishful and symbolic than realistic for a White House juggling many late-term agenda items. And traditionally, the budget office’s review of agency proposals can take months.”
  • Per Fierce Pharma,
    • “As Donald J. Trump gradually fills out his cabinet, the President-elect’s latest pick could bode well for biopharma business development over the next four years.
    • “Trump on Tuesday nominated Andrew Ferguson to lead the U.S. Federal Trade Commission (FTC). Ferguson is one of two Senate-confirmed Republican FTC commissioners appointed by President Joe Biden, Reuters notes.
    • “At the same time, Trump said in a post on Truth Social that he plans to nominate Mark Meador, a partner at the law firm Kressin Meador Powers, to become an FTC commissioner. Should he be confirmed for the job, Meador will take over the spot currently filled by FTC chair Lina Khan, whose term at the antitrust agency has expired, the news agency said.”

From the public health and medical research front,

  • Per MedPage Today,
    • “A possible case of H5N1 bird flu virus in a California child has been linked to raw milk consumption and is under investigation by state health officials and the CDC.
    • “The patient experienced fever and vomiting after drinking raw milk and has since recovered, according to an announcement by Marin County Public Health. Officials said that the risk to the public remains low, as there was no evidence of person-to person transmission between the child and her family members.
    • “The case stands out for being outside the usual farm work setting.”
  • The New York Times adds,
    • “Domestic cats could provide an unexpected new route for the bird flu virus H5N1 to evolve into a more dangerous form, according to a new study published on Monday.
    • “In the year since the virus began circulating in dairy cattle, it has killed many cats, primarily on farms with affected herds. It has also sickened at least 60 people, most of whom had close contact with infected dairy cows or poultry.
    • “So far, H5N1 does not spread easily among people, although studies have suggested that just one or two key mutations could allow the virus to make that leap.
    • “There is no evidence that cats have spread H5N1 to people and they may not represent a major avenue for the evolution of bird flu, experts said. Still, if a cat were simultaneously infected with H5N1 and a seasonal flu virus, the H5N1 virus could potentially acquire the mutations it needed to spread efficiently among people.”
  • ABC News reports,
    • “The rates of late-stage breast cancer at diagnosis have risen among women in all racial and ethnic groups, but Black women have been hit the hardest, according to a new study published in the journal Radiology.
    • “The study, which looked at data from 2004 to 2021, found that advanced breast cancer rates have risen among women of all ages, with the sharpest increases in young women aged 20 to 39, and women over 75.
    • “Black women experience advanced diagnoses 55% more often than white women and are more likely to die from the disease, the study found.
    • “While mammography does save lives by catching cancer earlier, fewer than 70% of eligible women are up to date on their screenings, the study found.
    • “This trend is particularly alarming because early detection significantly improves survival. Five-year survival rates drop drastically from 99% for early-stage breast cancer to just 31% when the cancer is more advanced and has already spread to other parts of the body, the study found.”
  • BioPharma Dive adds,
    • “An experimental breast cancer drug developed by Eli Lilly met its main goal in a Phase 3 study, helping people with a form of HER2-negative, ER-positive disease stay alive and progression free for longer than standard hormone-suppressing therapies, according to data disclosed Wednesday.
    • “When combined with Lilly’s approved medicine Verezenio, the experimental drug, called imlunestrant, also helped women stay alive and progression free longer than treatment with imlunestrant alone regardless of their mutation status, according to results of the EMBER-3 trial presented at the San Antonio Breast Cancer Symposium. The data were also published in The New England Journal of Medicine.”
  • Per a National Institutes of Health press release,
    • “National Institute of Health (NIH) scientists have made a significant breakthrough in understanding how “bad” cholesterol, known as low-density lipoprotein-cholesterol or LDL-C, builds up in the body. The researchers were able to show for the first time how the main structural protein of LDL binds to its receptor – a process that starts the clearing of LDL from the blood – and what happens when that process gets impaired.
    • “The findings, published in Nature, further the understanding of how LDL contributes to heart disease, the world’s leading cause of death, and could open the door to personalizing LDL-lowering treatments like statins to make them even more effective.
    • “LDL is one of the main drivers of cardiovascular disease which kills one person every 33 seconds, so if you want to understand your enemy, you want to know what it looks like,” said Alan Remaley, M.D., Ph.D., co-senior author on the study who runs the Lipoprotein Metabolism Laboratory at NIH’s National Heart, Lung, and Blood Institute.” * * *
    • “The study findings could open new avenues to develop targeted therapies aimed at correcting these kinds of dysfunctional interactions caused by mutations. But, as importantly, the researchers said, they could also help people who do not have genetic mutations, but who have high cholesterol and are on statins, which lower LDL by increasing LDLR in cells. By knowing precisely where and how LDLR binds to LDL, the researchers say they may now be able to target those connection points to design new drugs for lowering LDL from the blood.” 
  • STAT News points out,
    • “Gilead said Tuesday that it will soon begin Phase 3 testing for a drug it believes could prevent HIV infection with just a single shot every year.
    • “Such a medicine, if proven effective, would be the closest thing to a vaccine the HIV field has produced in four decades of research. The company plans to begin the trial next year, with an eye toward regulatory filings in late 2027.”

From the U.S. healthcare business report,

  • Health Affairs reports,
    • “Numerous studies show that employer plans pay providers significantly more than Medicare, but less is known about prices in nongroup plans sold both on and off the Marketplaces established by the Affordable Care Act (ACA), where narrow networks and low-cost insurers are more prevalent.
    • “We estimated prices for three market segments (Marketplace nongroup, off-Marketplace nongroup, and employer small group) and three types of services (professional, outpatient hospital, and inpatient hospital) relative to a Medicare benchmark.
    • “We used 2021 claims data covering virtually all enrollment in ACA risk-adjusted plans. In aggregate, in 2021, Marketplace prices were 152 percent of Medicare prices, whereas the prices paid in small-group employer plans were 179 percent of Medicare prices.
    • “Comparing across market segments, relative to employer small-group plans, Marketplace professional prices were 6.9 percent lower, inpatient prices were 13.3 percent lower, and outpatient prices were 26.3 percent lower. Off-Marketplace prices fell between Marketplace and employer small-group prices.
    • “The finding that nongroup prices were significantly lower than prices paid by employer small-group plans—more so than indicated by prior research—is important for understanding federal subsidies and affordability for nongroup coverage and evaluating policies such as a nongroup public option with prices capped at a percentage of Medicare prices.”
  • Per Healthcare Dive,
    • “For the first time in 27 months, Fitch Ratings is revising its credit outlook for the nonprofit hospital sector — lifting it from deteriorating to neutral in its 2025 outlook report and adding that hospitals have made “enough meaningful strides” to warrant the revision.
    • “Hospitals have seen “steady improvement” on operating margins, according to the Monday report. The trend is attributable to providers’ success controlling labor expense growth, as well as stronger cash flows and equity returns.
    • “Fitch predicts margins will continue to improve, with operators reporting median operating figures between 1% and 2% in 2025. However, if President-elect Donald Trump announces cuts to Medicaid or supplemental Medicaid funds, margins could be adversely impacted and the sector’s outlook may be reverted to deteriorating.”
  • Modern Healthcare informs us,
    • “Labcorp has completed its acquisition of select non-hospital lab assets from Ballad Health, the independent laboratory company said Wednesday. A purchase price was not immediately available.
    • “Johnson City, Tennessee-based Ballad Health will retain operations of its inpatient and emergency department laboratory services, as well as lab services for hospital-based practices, according to a news release.” * * *
    • “The latest deal continues a trend of health systems selling off parts of their laboratory business to save on costs and focus on other areas of their operations. Independent lab companies often can provide a higher volume of tests at a lower cost compared with hospitals performing tests at their own facilities.” 

Monday Report

David Ermer–Congress, FDA, Medical / Rx research, Medicare, Rx coverage, SDOH, U.S. Healthcare–
  • The Wall Street Journal reports,
    • “The all-out pursuit of the criminal suspect who gripped the public’s imagination for nearly a week ended on Monday at a McDonald’s in central Pennsylvania, about a half mile from the Greyhound bus station in a nondescript part of this town.
    • “A worker there noticed something familiar about a lone customer on Monday morning and called the local police. Soon 26-year-old Luigi Mangione, the subject of a massive manhunt and the man police suspect murdered UnitedHealthcare Chief Executive Brian Thompson in Manhattan last week in a targeted killing, was in custody.
    • ‘When, at last, he was unmasked—and unhooded—the mystery man at the heart of the brazen and apparently carefully plotted attack was even more of a riddle than expected. Held up as folk hero by some for striking a blow against America’s health insurers, he turned out to be a high-achieving product of elite schools, an affluent Ivy Leaguer who harbored anti-capitalist leanings that may have played a role.
    • “A review of his reading diet suggested that, at some point, his ideas about activism had crossed into an interest in violence. In January he wrote a chilling review on the Goodreads book-review site of Theodore John Kaczynski’s “Industrial Society and Its Future,” also known as “The Unabomber Manifesto.” He gave it four stars. 
    • “In Mangione’s review, he wrote: “A take I found online that I think is interesting”:
    • “Had the balls to recognize that peaceful protest has gotten us absolutely nowhere and at the end of the day, he’s probably right…. When all other forms of communication fail, violence is necessary to survive. You may not like his methods, but to see things from his perspective, it’s not terrorism, it’s war and revolution.”
  • The New York Times adds,
    • “Luigi Mangione will most likely be transferred to a Pennsylvania state correctional facility this evening, according to Gov. Josh Shapiro. Mangione faces two felony charges related to a firearm and false ID, and three misdemeanors — two relating to possession and use of a false ID and one relating to possession of an instrument of a crime.”
  • Per Beckers Hospital Review, United Health Group CEO Andrew Witty, whom Modern Healthcare named as the most influential person on U.S. healthcare, remarked to employees last Friday:
    • “I’m sure everybody has been disturbed by the negative and in many cases vitriolic media and commentary that has been produced over the last few days, particularly in the social media environment,” Mr. Witty said. “There are very few people in the history of the U.S. healthcare industry who had a bigger positive effect on American healthcare than Brian.”
    • “Our role is a critical role, and we make sure that care is safe, appropriate and is delivered when people need it,” he said. “We guard against the pressures that exist for unsafe care or for unnecessary care to be delivered in a way which makes the whole system too complex and ultimately unsustainable.”
  • Healthcare Dive reminds us that “Hospitals seek to prevent, mitigate attacks on clinical staff. After attacks on healthcare workers soared during the COVID-19 pandemic, providers have scrambled to address heightened violence in their workplaces.”

From Washington, DC,

  • STAT News reports,
    • “Legislation to restrict U.S. drugmakers from using key Chinese contract manufacturers was dealt a major blow when senators left it out of a must-pass defense budget bill this weekend.
    • “The BIOSECURE Act would prohibit pharmaceutical and biotechnology companies from using services or equipment from Chinese “companies of concern,” including WuXi AppTec and WuXi Biologics, in work that is contracted or funded by the U.S. federal government. Industry has come to rely heavily on those companies for contract manufacturing and other important services. Without the WuXi companies, costs for those services would go up.”  
  • Politico adds,
    • “It’s crunch time for Democrats and Republicans to come to a deal on a health care package to attach to government funding.
    • “The soft deadline for releasing bill text for a stopgap funding patch is usually the Sunday before the deadline. That means it would have to be out by Dec. 15 ahead of the Dec. 20 deadline. House Speaker Mike Johnson has targeted this week to release the legislation, leaving little time for lawmakers to agree on a health care package.
    • “Several other issues must still be resolved, including disaster-aid spending, which could complicate efforts on health care provisions.
    • “The state of play: Republicans and Democrats exchanged offers last week on a health care package. They aren’t far apart on some issues that might be easier to resolve — extending telehealth and hospital-at-home care rules and averting doctor pay cuts — but have significant differences to reconcile, including how to pay for it.
    • “Democrats propose regulations for pharmacy benefit managers — companies that negotiate drug prices for insurers or employers — that go beyond Republicans’ offer. Republicans propose repealing a Biden-era rule to increase nursing home staffing, a move they had already planned for next year. Democrats are also pushing to extend enhanced Affordable Care Act plan subsidies, but it’s not necessarily a line in the sand.
    • “Other issues being discussed include a potential compromise on legislation aimed at cracking down on Chinese biotechs. That didn’t hitch a ride on a negotiated version of a must-pass defense policy bill, the National Defense Authorization Act, released Saturday.
    • “If both sides agree to negotiate in good faith, a deal shouldn’t be that far away — in theory, at least. Republicans could have incentive to walk away when they will gain full control of Washington in weeks, while Democrats could force Republicans to come to a deal with a slim House majority next Congress.”
  • The American Hospital Association News tells us,
    • The AHA Dec. 9 said it supports a potential Medicare $2 Drug List Model, where people enrolled in a Part D plan would have access to certain prescription drugs for a low, fixed copayment no higher than $2 for a month’s supply per drug.  
    • “Providing low, fixed copayments for common generic drugs, as CMS proposed, could help increase medication adherence and improve health outcomes,” AHA wrote. “This model would standardize cost sharing for certain drugs for beneficiaries with Medicare Part D enrolled in a participating plan and their health care providers.” 
    • The AHA provided recommendations for how to account for shortages in the approved drug list and for public rulemaking to update the drug list annually, as well as feedback on potential quality measures for the model. Additional details on the request for information can be found on the M2DL webpage.

From the public health and medical research front,

  • The American Medical Association lets us know “what doctors wish patients knew about endometriosis.”
  • BioPharma Dive adds in a Deep Dive, “Endometriosis drug research, long underfunded, confronts familiar problems in women’s health. Up to 10% of women globally have endometriosis, yet the often-misunderstood disease largely remains off of drugmakers’ radar screens.”
  • Consumer Reports, writing in the Washington Post, reflects, “Meds like Wegovy are all over the news. But are they right for you, especially if you’re older than the average user?”
  • Per a press release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of suzetrigine (Vertex Pharmaceuticals) for the treatment of acute pain. 
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.” * * *
    • “The Evidence Report will be the subject of a virtual public meeting of the Midwest CEPAC on February 28, 2025. During the meeting, the independent council will vote on key questions raised in the report. Registration for the virtual public meeting is now open.“
  • The Wall Street Journal relates,
    • “GSK’s blood-cancer drug Blenrep showed positive overall survival data in a late-stage trial, increasing the likelihood for the treatment to return to market next year.
    • “The data showed that Blenrep, in combination with other drugs, reduced the risk of death by 42% in patients with multiple myeloma whose first treatment didn’t work or who had severe side effects, compared with Johnson & Johnson’s Darzalex, the British pharma giant said Monday.
    • “This represents a survival improvement of nearly three years compared with Darzalex combinations, supporting the potential for Blenrep combinations to become the new standard of care, GSK said.
    • “The U.S. Food and Drug Administration’s approval of Blenrep is expected on July 23, marking a comeback for the treatment in the U.S. In November 2022, the company withdrew the treatment after a trial revealed that Blenrep, then used alone, didn’t outperform an existing treatment.”
  • STAT News reports from the American Society of Hematology’s conference being held in San Diego
    • “From STAT’s Andrew Joseph: AbbVie said this morning that its drug tavapadon succeeded in another Phase 3 study in Parkinson’s disease, helping improve patients’ symptoms and quality of life.
    • “The TEMPO-2 trial tested flexible doses of tavapadon, ranging from 5 to 15 milligrams a day, in patients with early Parkinson’s. The study met its primary endpoint, with patients on the drug showing a greater improvement after 26 weeks on a scale that measures symptoms and quality of life versus those on placebo. Specifically, patients on the study drug had an improvement of 10.3 points on the scale, known as MDS-UPDRS, while those on placebo saw a 1.2-point worsening, a statistically significant difference.
    • “Tavapadon, a daily pill, works by partially activating the D1 and D5 dopamine receptors. In addition to the new flexible-dosing trial, the drug has also had positive Phase 3 trials when tested only at a high dose and when tested in combination with common dopamine therapy.
    • “AbbVie plans to submit tavapadon to the FDA next year. It acquired the drug through its purchase of Cerevel Therapeutics, a deal whose centerpiece was an experimental schizophrenia drug called emraclidine. Last month, however, AbbVie reported that emraclidine failed in two studies.”
  • and
    • “Johnson & Johnson and Genmab’s multiple myeloma drug Darzalex reduced the risk of disease progression by 51% among people with the pre-symptomatic, or “smoldering,” form of the disease, when compared with those who were only actively monitored for progression, according to new data presented at ASH on Monday.
    • “There are no approved treatments for smoldering multiple myeloma; patients are typically checked regularly through blood tests and other assessments. In a trial called AQUILA, J&J enrolled 390 people with smoldering myeloma at high risk of progression and randomized about half to receive Darzalex, with the others only monitored for progression. Patients were then evaluated for a median of nearly five and a half years.
    • “After five years, 63% of trial participants treated with Darzalex were alive and hadn’t progressed, compared to 41% of those who were actively monitored. Of those receiving Darzalex, 93% were still alive after five years, versus 87% of those in the control group. J&J has already asked regulators in the U.S. and Europe to approve Darzalex for smoldering multiple myeloma.
  • and
    • “Patients from disadvantaged neighborhoods were 33% less likely to receive a lifesaving bone marrow transplant, and faced a higher risk of death without one, new research from Fred Hutchinson Cancer Center that was presented at ASH shows. That said, survival rates post-transplant were consistent across socioeconomic groups.
    • “It really drills down on some of these social determinants of health as being access barriers for patients,” Jeff Auletta, the health equity chief at the National Marrow Donor Program, who was not involved in the study, told STAT.”
  • BioPharma Dive informs us,
    • “One year on from the landmark U.S. approval of two powerfully effective gene therapies for sickle cell disease, the treatments have been barely used, a sluggish start that reflects the myriad challenges of launching them.
    • “While some five-dozen people with the blood disorder have begun the treatment process for one or the other therapy, only two had actually received an infusion through mid-November, according to the therapies’ developers, Vertex Pharmaceuticals and Bluebird bio. That’s because the process typically lasts at least several months, involving a precise choreography of medical consultations, preparatory treatments and bespoke manufacturing of the two personalized therapies, called Casgevy and Lyfgenia.” * * *
    • “Some 100,000 people in the U.S. are estimated to have sickle cell. Vertex and Bluebird believe somewhere between one-sixth and one-fifth of that total population may be eligible for Casgevy and Lyfgenia, but only a slice will likely seek them out in the first few years.
    • “[Dr. Martin] Steinberg, [a hematologist] at Boston Medical Center, believes the current gene therapies will remain something of a niche product for the time being. “As we get more skillful at getting patients through the process, that won’t be as much of a stumbling block. Maybe we will be able to do one a month or so [at Boston Medical Center],” he said. “But it’s still too early for us to know if this is going to be realistic.”

From the U.S. healthcare business front,

  • Kaufmann Hall released its October 2024 National Hospital Flash Report. Here are the key takeaways:
    • “Overall, October data show continued stability. Revenue, average length of stay, and other indicators show stable performance.
    • “Outpatient revenue continues to grow. Revenue growth has been steady over the past few years, indicating a shift in how patients seek care.
    • “Discharges per calendar day increased compared to the previous month. This has led to a decrease in overall expenses on a volume adjusted basis, though supplies and drug expenses continue to grow.”
  • Beckers Hospital Review points out “ten health systems that recently had their outlooks upgraded by Fitch Ratings or Moody’s Investors Service.”
  • ALM Think Advisor explains why “Drug Cost Planning Is About More Than Choosing Plans.”
    • “Smart clients who want good benefits likely are paying higher premiums.
    • “One subtle short-term threat: skimpier coverage.
    • “A long-term concern: the fate of the new $2,000 annual out-of-pocket spending cap.”
  • MedTech Dive tells us,
    • “ECRI placed artificial intelligence-enabled applications at the top of its list of health technology hazards in 2025.
    • “ECRI, which released the list last week, said biases in the AI training data “can lead to disparate health outcomes or inappropriate responses,” adding that the technology can provide false or misleading outputs. The issues led the patient safety group to warn that putting too much trust in AI can result in inappropriate care decisions. 
    • “Other top health technology hazards for 2025 include the unmet technology support needs of home care patients, cybersecurity threats and substandard or fraudulent medical devices.”

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.”

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, FDA, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec let us know,
    • “The top House Republicans for veterans’ issues are pushing a new measure to codify and expand privatized health care on the taxpayer dime, reigniting a controversial issue that is likely to come back to the fore under President-elect Trump. 
    • “The Complete the Mission Act would serve as a followup to the 2018 Mission Act that Trump signed into law, which streamlined and expanded veterans’ access to private sector care paid for by the Veterans Affairs Department. Congress passed the Mission Act on a bipartisan basis to follow a 2014 law with similar goals, but lawmakers have since disagreed over its implementation. 
    • “The new bill, introduced by House Veterans Affairs Committee Chairman Mike Bost, R-Ill., would ensure existing access standards for private sector “community care” are codified in law. Those rules allow veterans living more than a 30-minute drive on average from the nearest VA facility to access the community care network for services such as primary care, mental health and some extended care. For specialized care, veterans must live more than a one-hour drive from the nearest VA facility. They can also access private care when a close VA facility does not provide the service they are seeking, or when their VA doctor recommends it. 
    • “Bost’s measure would expand extended care options in the private sector and bar VA from considering telehealth availability when calculating community care eligibility. It would also require VA to consider veterans’ preference of where to seek treatment. The bill would create a three-year pilot in which patients could enroll in non-VA outpatient mental health or substance use treatment without requiring.”
  • Federal News Network informs us,
    • “Agency leaders in charge of combatting fraud are highlighting the importance of workforce training and data sharing, as the White House touts a deep decline in the governmentwide rate of improper payments.
    • “The Office of Management and Budget last week reported the governmentwide rate improper payment rate had fallen to 3.97%, the lowest since 2014. The rate has dropped by nearly 50% since fiscal 2021, when improper payments and fraud soared amid emergency COVID relief spending.
    • “The total amount of improper and unknown payments in fiscal 2024 was $161.5 billion, compared to just under $236 billion in fiscal 2023, according to data posted on PaymentAccuracy.gov.
    • “The White House said the past year’s progress was driven by “a government-wide approach focused on improving up-front controls, prioritizing fraud prevention, and driving increased collaboration between agencies and their inspectors general.”
  • The Internal Revenue Service announced that “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2024, and before October 1, 2025, is $3.47.
  • The Office of Personnel Management’s Inspector General released her latest semi-annual report to Congress.
  • Adam Fein, writing in his Drug Channels blog, shares four revelations about Minnesota’s first 340B program transparency report.

From the public health and medical research front,

  • STAT News reports,
    • “At the annual meeting of the Menopause Society earlier this fall, researchers presented new evidence that hormone therapy can be beneficial to menopausal women’s heart health, reducing insulin resistance and other cardiovascular biomarkers. It was the latest in a long line of research showing the benefits of hormone therapy for women in menopause, which also includes alleviating symptoms like hot flashes, sleep disturbances, vaginal dryness, and pain during sex.
    • “But despite this evidence, hormone therapy’s use has plummeted over the past few decades. In 1999, almost 27% of menopausal women in the U.S. used estrogen. By 2020, less than 5% did. 
    • “So why aren’t more women in menopause taking advantage of treatments known to be effective? Misconceptions about the risks of hormone therapy are one reason, according to experts. So is the lingering cultural taboo around discussing menopause, which has created “a perfect storm for under-treatment,” said Theodoros Kapetanakis, an OB-GYN at Mount Auburn Hospital’s Endometriosis Center in Waltham, Mass.” 
  • Healio tells us.
    • “The beneficial impact of physical activity on mortality risk remained consistent across the adult lifespan, even growing stronger later in life, according to study results published in JAMA Open Network.
    • “In contrast, other modifiable health factors saw their effects on the risk for mortality decrease with increasing age.
  • RAND offers a report titled “Improving the Detection of Cognitive Impairment and the Pathway to Treatment.”‘
    • “Low cognitive ability, functional limitations, and poor physical health are strong predictors of dementia as many as 20 years before its onset. Lifestyle factors, such as never drinking alcohol or drinking excessively, never exercising, and low engagement in hobbies, are associated with cognitive impairment and dementia.
    • “Early detection of cognitive impairment helps people take mitigating actions to prepare for future loss of their financial and physical independence.
    • “Older adults’ take-up of cognitive testing is low, and many who do get tested exit the clinical care pathway before being diagnosed and receiving treatment. Take-up of cognitive tests would increase if tests were free and readily accessible. Treatments would be more palatable if they had fewer side effects and helped patients maintain independence longer.
    • “More engagement of primary care practitioners and team-based care in the clinical care pathway and the use of new technologies, such as blood-based biomarkers, could ease health care system capacity constraints on dementia specialists and reduce wait times for patients.”
  • McKinsey & Company offers ideas about “How to address healthcare inequities for people with disabilities.”
    • “Globally, people with disabilities have a mortality rate that is 2.24 times higher than those without disabilities. And although people with disabilities often have greater healthcare needs, they also experience more and higher barriers to care. McKinsey’s Dr. Mona Hammami and coauthors write that in the patient care pathway, people with disabilities are more likely to report:
      • “skipping or delaying care because of cost
      • “having difficulty securing transportation to a health facility
      • “encountering inaccessible facilities
      • “meeting workers with inadequate skills or flexibility to provide quality care
    • “This International Day of Persons with Disabilities (IDPD), examine inequities in the patient care pathway, potential interventions to overcome them, and a three-step approach to reducing inequities across communicable and non-communicable disease types.”
  • The New York Times reports
    • “Health officials have closed their investigations into an E. coli outbreak linked to raw onions on McDonald’s Quarter Pounder hamburgers that sickened more than a hundred people, the Food and Drug Administration (FDA) announced Tuesday.
    • “In total, 104 people from 14 states were sickened from the contaminated food and 34 were hospitalized. One older person in Colorado died.
    • “Officials said there did not appear to be a “continued food safety concern,” because McDonald’s had not served slivered onions — which investigators determined to be the “likely source of contamination”— on the Quarter Pounders for more than a month. The onions were recalled. And in many states, Quarter Pounders were removed from the menu altogether for several weeks.
    • “There have not been any new illnesses since McDonald’s decided to remove the onions from its menu on Oct. 22, according to the Centers for Disease Control and Prevention.”
  • Per an FDA announcement,
    • “On Monday, the FDA updated the outbreak advisory for Salmonella Typhimurium infections linked to cucumbers. As of November 26, 2024, a total of 68 people infected with the outbreak strain of Salmonella have been reported from 19 states. Of the 50 people for whom information is available, 18 have been hospitalized. No deaths have been reported. Of the 33 people interviewed, 27 (82%) reported eating cucumbers.
    • “On November 27, 2024, SunFed Produce, LLC initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. in Sonora, Mexico. On November 29, 2024, Baloian Farms of Arizona Co., Inc. initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. On December 1, 2024, Russ Davis Wholesale initiated a voluntary recall of American/slicer cucumbers and multiple products containing recalled cucumbers.
    • “The FDA is working with the recalling firms and their direct customers to determine if additional downstream customer recalls are necessary. The FDA’s investigation is ongoing.”

From the U.S. healthcare business front,

  • Modern Healthcare relates,
    • “Kaiser Permanente-backed Risant Health acquired Cone Health on Sunday, making it the second health system to join Risant in less than a year.
    • “Cone is following in the footsteps of Geisinger Health, which was folded into the newly-formed Risant in March. Kaiser created Washington, D.C.-based Risant earlier this year as a nonprofit entity to buy systems and form a national network for value-based care.” * * *
    • “Having two of these close in one year has made for a pretty busy year,” said Dr. Jaewon Ryu, CEO at Risant. “It’s great to get on the other side of the regulatory approvals and finalize welcoming [Cone] into Risant Health.”
  • Beckers Hospital Review notes,
    • “California was CommonSpirit’s top-performing market in terms of margins in the first quarter of fiscal year 2025 (the three months ending Sept. 30) but the Chicago-based system’s South region, which includes Texas and Kentucky, “remains challenged,” Benjie Loanzon, senior vice president and corporate controller, said during the company’s Dec. 2 earnings call. 
    • “We are taking a range of actions in this region, focusing on our ambulatory strategy,” Mr. Loanzon said. “We are encouraged by recent performance improvements, though a significant amount of work will be needed to reach an acceptable level [of] performance.”
    • “CFO Dan Morissette said the health system continues to look at ways to improve the South region’s performance. Key focus areas include contracting, efficiency, growth and cost containment. 
    • “Although Texas didn’t perform well in Q1, we are encouraged by other achievements in terms of the volume and cost containment,” Mr. Loanzon said. “Kentucky is the most improved market in terms of the financial performance. In terms of the volume and cost containment, it has a positive EBIDTA compared to the past.”
  • Per BioPharma Dive,
    • “Shares of Janux Therapeutics surged to record highs following the release of study results for a drug that, if ultimately successful in testing, would represent a new type of therapy for prostate cancer. 
    • “The findings come from an early-stage study testing the biotechnology company’s therapy, dubbed JANX007, in 16 people with a form of advanced prostate cancer. Data Janux first disclosed earlier this year vaulted the company’s market value past $2 billion. While early and from a small clinical trial, the new results announced Monday afternoon pushed Janux’s shares nearly 75% higher, changing hands Tuesday morning at more than $70 apiece.”‘
  • Beckers Payer Issues tells us how much health plans are paying for GLP-1 drugs.
    • The prices for some GLP-1s have dropped significantly in recent years for individuals covered by Medicare and commercial insurance, according to a new report from HHS,
    • In 2024, the U.S. list prices for a one-month supply for most GLP-1s are stable or increasing, but after payer negotiations and rebates, net prices for many GLP-1s have decreased since 2022. Net prices for GLP-1s are between 24% and 73% lower than list prices, indicating that most insurers are paying less than the manufacturer’s list price.
    • “In the net prices, we see evidence of the impact of competition as new drugs in the class enter the market,” HHS wrote. “While list prices are consistently stable or increasing, for many of these drugs, including Ozempic, Rybelsus, Saxenda, and Victoza, net prices fell.”
  • Healthcare Dive explains “Healthcare organizations must carefully vet AI tools, address patient concerns and keep an eye on standards and regulation, according to industry experts who spoke at a Healthcare Dive virtual event.”

Happy Thanksgiving!

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

The FEHBlog will be back on Friday.

From Washington, DC,

Transition News

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

Medicare / GLP-1 Drug News

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

Federal Employment Tidbits

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

FDA News

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Roundup

David Ermer–CDC, CMS, FDA, Medical / Rx research, SCOTUS, Telehealth, U.S. Healthcare–

From Washington, DC,

Photo by Sven Read on Unsplash
  • Govexec tells us,
    • “The U.S. Postal Service said it is well positioned to handle a blitz of mail and packages ahead of the holiday season, though it will confront its busiest time of the year after once again hiring fewer seasonal employees. 
    • “USPS will bring on just 7,500 temporary workers to help the agency complete processing and delivery efforts, with employees having started as early as October and staying on as late as mid-January. That is down slightly from its target of 10,000 hires last year and precipitously from 45,000 in 2021. Postal management has maintained that its efforts to convert nearly 200,000 part-time staff to full-time, career employees over the last several years has mitigated its need to onboard seasonal workers. “
  • The American Hospital Association News lets us know,
    • “More than 496,900 consumers who currently do not have health insurance coverage have signed up for a 2025 health plan through the federally facilitated Health Insurance Marketplace, the Centers for Medicare & Medicaid Services reported last week. They join over 2.5 million returning consumers who selected plans for 2025 during the open enrollment period. Open enrollment began Nov. 1 and continues through Jan. 15. Last year, 21.4 million people signed up for coverage.” 
  • Per an HHS press release,
    • “The Administration for Strategic Preparedness and Response (ASPR), part of the U.S. Department of Health and Human Services, today announced two additional Defense Product Act (DPA) Title III Active Pharmaceutical Ingredient (API) investments focused on solving ongoing drug shortages. These new investments seek to rebuild and protect the U.S. public health supply chain as an essential part of national defense.” * * *
    • “Under DPA Title III, ASPR’s Office of Industrial Base Management and Supply Chain (IBMSC) will provide $32.4 million to Manus Bio, Inc., a private company in Waltham, Massachusetts, to expand its facilities for the production of key starting materials for essential medicines. Manus will utilize biomanufacturing and incorporate a continuous flow process which enables automated multi-step chemical synthesis. Manus has developed a suite of optimized microbial chassis which gives access to more than 150,000 natural products, known as bioalternatives, including terpenoids, polyketides, phenylpropanoids, and flavonoids.  
    • “ASPR IBSMC also will provide up to $12 million to Antheia, Inc., a private pharmaceutical ingredient manufacturer located in Menlo Park, California. Antheia’s biomanufacturing platform leverages bioengineering and computational biology to produce critical drug substances in an efficient and scalable one-step fermentation process. Antheia will focus on key starting materials and APIs used in the production of essential medicines.”
  • KFF considers “how [a bunch of] pending health-related lawsuits could be impacted by the incoming Trump Administration.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Bird flu, a virus that can also affect humans, has been discovered in a batch of raw milk sold in California store refrigerators, state regulators said Sunday. While there have been no reported illnesses in this most recent case, it comes just a few days after a child tested positive for bird flu for the first time in U.S. history.
    • “A batch of whole raw milk from Raw Farm that has a “best by” date of Nov. 27, 2024, has been recalled after Santa Clara County health officials detected bird flu in a sample purchased for testing, the California Department of Public Health said in a news release. The farm is in Fresno County.
    • “Retailers have been notified to pull the product from their refrigerator racks, the state health department said. Consumers who may have it in their homes are advised not to drink it.”
  • MedPage Today adds,
    • “Last week, it was reported that an infant died from a Listeria infection in an outbreak tied to ready-to-eat-meat products. Meanwhile, recalls continue after an outbreak of Escherichia coli from bagged organic carrots led to 15 hospitalizations and a death.
    • “What seems like a marked rise in reports of foodborne illnesses in recent months may not be an illusion — but experts say the reasons behind a presumed increase may be more related to how we track these outbreaks than the outbreaks themselves.”
  • The American Medical Association explains what doctors wish their patients knew about peripheral artery disease.
  • Consumer Reports, writing in the Washington Post, tells us “Sugar substitutes are everywhere. How safe are they to eat? Manufacturers are responding to growing demand by using non-sugar sweeteners to replace some or all of the sugar in many foods and drinks.”
  • Per STAT News,
    • “Alector Therapeutics said Monday that its Phase 2 trial for an experimental Alzheimer’s antibody failed, dealing a blow to what had been one of the leading dark horse approaches to treating the neurodegenerative disease.
    • “The drug, called AL002, is designed to activate a group of surveilling neuronal immune cells called microglia. It was among several efforts, now in or nearing clinical trials, predicated on the notion that modulating the brain’s immune system could slow the degenerative disease. 
    • “In the 381-person trial, however, patients who received AL002 didn’t decline more slowly than patients who were on placebo, as measured by a scale called the Clinical Dementia Rating Sum of Boxes. Alector said the trial also failed to show an effect on secondary measures of cognition and function, or on biomarkers associated with the disease, such as amyloid levels.”
  • Per Fierce Pharma,
    • “Incyte’s previously disclosed phase 3 win in relapsed or refractory follicular lymphoma (R/R FL) sent the company racing to file an expansion bid for its Monjuvi (tafasitamab) by year-end. Now, a clearer picture of the drug’s success in the patient population has been revealed courtesy of a research paper published ahead of this year’s American Society of Hematology Annual Meeting & Exposition.
    • “In the phase 3 inMIND study, Monjuvi—added to Bristol Myers Squibb’s Revlimid and Roche’s Rituxan—triggered a 57% reduction in the risk of disease progression, relapse or death in R/R FL patients compared with those who were treated with placebo, Revlimid and Rituxan, according to the paper.
    • “Researchers determined a median investigator-assessed progression free survival of 22.4 months for the treatment arm versus 13.9 months for the control group. The benefits in progression-free survival were consistent across subgroups, the researchers said.”
  • and
    • “After a recent failed showing in a breast cancer subgroup raised doubts around AstraZeneca’s Truqap, the first-in-class AKT inhibitor is making inroads in a prostate cancer subtype.
    • “High-level results from the company’s ongoing CAPltello-281 phase 3 study demonstrated that a combination of Truqap, Johnson & Johnson’s Zytiga and androgen deprivation therapy (ADT) delivered statistically significant and clinically meaningful improvements on the trial’s primary endpoint of radiographic progression-free survival (rPFS), AZ said on Monday.
    • “The trial compared the regimen versus the standard-of-care Zytiga and ADT in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC), a specific type of prostate cancer with a particularly poor prognosis, AZ said in its Monday press release.”
  • Per BioPharma Dive,
    • “Adding Merck & Co.’s new cardiovascular drug Winrevair to background therapy helped people with severe lung hypertension stay alive and avoid invasive medical care longer than those who only received background therapy, the company said Monday.
    • “Data from the ZENITH trial could potentially expand use of a drug that’s now forecast to earn $5 billion a year at its peak. A trial steering committee stopped the trial early at an interim checkpoint because data indicated the Winrevair combination clearly outperformed placebo, Merck said.
    • “Merck obtained Winrevair in 2021 with its $11 billion acquisition of Acceleron in 2021. The pharmaceutical company is looking for sales of heart disease drugs to drive growth in coming years as its biggest seller, the cancer treatment Keytruda, loses market exclusivity later in the decade.”
  • and
    • “An experimental, muscle-preserving drug from Biohaven fell short of its goal in a Phase 3 study of people with spinal muscular atrophy, but showed enough promise in its effects on body composition that the company plans to advance it as a treatment for obesity.
    • “A regimen of Biohaven’s drug, taldefgrobep alfa, and a standard SMA therapy didn’t significantly improve motor function after 48 weeks compared to treatment with a typical SMA medicine and placebo. Biohaven didn’t provide full study data in a Monday statement, but claimed it found “efficacy signals” in certain subgroups and plans to discuss potential paths forward in SMA with U.S. regulators.
    • “Treatment was associated with positive changes on body composition, Biohaven said. The “overall strength and consistency” of those findings has encouraged the company to “rapidly advance” the drug into a placebo-controlled Phase 2 trial in obesity by the end of the year.”

From the U.S. healthcare business front,

  • The Washington Post discusses at length hospital and emergency care at home programs.
  • Fierce Pharma informs us,
    • “After six straight quarters in which Eli Lilly or Novo Nordisk achieved the highest year-over-year revenue growth among the top companies in the biopharma industry, there was a new champion in the third quarter—and it was a major surprise.
    • “With a 32% increase in sales, Pfizer delivered the No. 1 bump among large drugmakers in the period, topping the sales growth figures for Novo (21%) and reigning champion Lilly (20%).
    • Pfizer’s performance came during a remarkable quarter of revenue growth for the industry. Of the industry’s top 20 companies by sales, nine posted double-digit increases and just three saw declines. This contrasts, for example, to the first quarter of 2023, when Novo at 27% was the only company with a double-digit increase in sales and was among only six of the top 20 drugmakers that had a year-over-year (YOY) revenue boost.”
  • Beckers Hospital Review warns that 705 rural hospitals are at risk of closure and discusses the ongoing legal battle between GLP-1 drugmakers and compound pharmacies.
  • MedCity News interviews Nworah Ayogu, head of healthcare impact at Thrive Capital, who suggests three mindset shifts that providers should adopt in order to succeed at consumer driven care.
  • Modern Healthcare reports,
    • “Mount Sinai Health System has opened a $100 million building dedicated to artificial intelligence.
    • “The Hamilton and Amabel James Center for Artificial Intelligence and Human Health is dedicated to the research and development of AI tools that can be used across the eight-hospital system, Mt. Sinai said Monday.
    • “The facility is housed in a 65,000-square-foot building on New York City’s Upper East Side near the system’s main campus. It will centralize Mount Sinai’s AI efforts in genomics, imaging, pathology, electronic health records and clinical care.”
  • MedTech Dive relates,
    • “Boston Scientific said Monday it has agreed to acquire Intera Oncology, which makes treatments for liver tumors primarily caused by metastatic colorectal cancer.
    • “Newton, Massachusetts-based Intera developed the Intera 3000 hepatic artery infusion (HAI) pump and chemotherapy drug floxuridine, both of which are approved by the Food and Drug Administration.
    • “The companies did not disclose the terms of the deal. Boston Scientific expects the acquisition to close in the first half of 2025, subject to closing conditions.”
  • Per Fierce Healthcare,
    • “Teladoc Health launched an artificial-intelligence-enabled technology that allows hospital staff to virtually detect when a patient is at risk of falling from a hospital bed. The solution, unveiled Monday and called Virtual Sitter, is now commercially available.
    • “Hospitalized patients may be at risk of falling from their hospital beds for innocuous reasons, such as needing to use the bathroom, leaning to get a cup of water or to reach a phone and contact family. Nearly 1 million hospitalized patients experience falls each year, and 30% result in lasting injuries, Teladoc Health cited in a press release.
    • “The Virtual Sitter uses AI to detect when a patient performs a movement that puts them at risk of falling. Using computer vision, the Virtual Sitter technology detects when the patient moves beyond set spatial boundaries. Teladoc’s advanced AI can distinguish the patient from other people in the room, can determine whether the patient is sitting up or lying down to determine risky movements, and tracks limb movements.
    • “On the other end of the Virtual Sitter is a hospital-trained, nonclinical staff person who can safely monitor up to 25% more patients with the technology. The AI movement detection alerts the remote staff member when a patient crosses the boundaries of the Bounding Box or moves in a risky fashion.”

Weekend Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.”