Congress is on the campaign trail until sometime after the national election on November 5.
The Supreme Court will hold its opening conference of its October term 2024 tomorrow. Among the cert petitions to be considered is the State of Oklahoma’s challenge to a 10th Circuit opinion holding that ERISA preempts an Oklahoma PBM reform law (No. 23-1213). That opinion is helpful to FEHB carriers. A Supreme Court decision to grant Oklahoma’s petition would be posted on FriCBS day October 4. A Supreme Court decision to deny Oklahoma’s petition or ask the Solicitor General for her views would be posted on Monday October 7.
MedCity News delves into the FTC’s recent administrative complaint against the big three PBMs’ handling of insulin pricing.
From the public health and medical research front,
CBS News reports that “Free COVID tests [from the federal government] are back. But there are more accurate tests for sale.”
“Three-dimensional imaging outperformed older digital mammography at reducing anxiety-producing callbacks for more breast cancer testing, a new study shows. The research, published this month in the journal Radiology also suggests the newer technology might find more worrisome cancers earlier during routine screenings.
“Lead author Dr. Liane Philpotts, a Yale School of Medicine radiology professor, hailed 3D mammography, also known as digital breast tomosynthesis or DBT, as “a win, win, win.”
“We have the benefit of a lower recall rate, or fewer false positives. We have increased cancer detection, and we have a lower rate of advanced cancers,” she said. “So it’s truly a game changer.” * * *
“Still, the new study, fails to definitively answer the question of whether newer, more expensive 3D mammography finds troublesome breast cancers earlier than 2D mammography, sparing women harsh treatment and saving lives, an accompanying editorial says.
“The verdict won’t come until 2030, at the conclusion of a large-scale randomized controlled trial comparing 3D to 2D mammography, according to the editorial written by two Korea University Guro Hospital radiology professors.
“Pending the 2030 trial results, the editorial concludes, the new study provides “indirect evidence suggesting the potential of DBT screening in improving survival outcomes.”
Fortune Well asks us “Getting enough sleep but still exhausted? These 7 types of rest can help.”
“Suicide rates are lower in U.S. counties with more health insurance coverage and broadband internet access and higher income, a recent Centers for Disease Control and Prevention analysis suggests.
“The report analyzed more than 49,000 suicide deaths in 2022 from the National Vital Statistics database. Researchers compared county suicide rates to the percent of residents with health insurance coverage, households with broadband access and households with income above the federal poverty level.
‘The overall U.S. suicide rate in 2022 was 14.2 per 100,000 people, the CDC report said. Suicide rates were highest among non-Hispanic American Indians or Alaska Natives (27.1 per 100,000 population) and White people (17.6 per 100,000). The suicide rate for boys and men was nearly four times higher than for girls and women (23 per 100,000 for males vs. 5.9 per 100,000 for females). Rural residents and those ages 45 to 64 (19 per 100,000) and 24 to 44 (18.9 per 100,000) had the highest suicide rate, according to the CDC report.”
“Dr. Ralph de la Torre, a former heart surgeon who built and became the face of Steward Health Care and its network of neglected hospitals, is stepping down from the company Tuesday and will no longer serve as board chairman and chief executive, the company said in a statement to the Globe Saturday.
“With his affinity for luxury yachts and corporate jets, de la Torre became a symbol of greed in for-profit health care, amid mounting stories this year of patients harmed by shortages of staff and critical supplies at Steward hospitals. De la Torre is believed to hold a majority of shares in the private company, which was one of the nation’s largest for-profit, private health care systems, and is now being taken apart in bankruptcy proceedings.”
“The Food and Drug Administration on Friday approved Regeneron Pharmaceuticals and Sanofi’s inflammatory disease drug Dupixent for a common lung condition. The decision could significantly expand use of what is already one of the industry’s best-selling medicines.
“Dupixent is now cleared for use as an add-on maintenance treatment for adults with a certain kind of chronic obstructive pulmonary disease, or COPD, that can’t be controlled with other medications.
“The decision makes Dupixent the first biologic medicine approved in the U.S. for COPD, a lung disease that makes it difficult to breathe and is typically treated with inhaled medicines. Regeneron estimates about 300,000 people in the U.S. have the specific type of COPD that would make them eligible for treatment with Dupixent, which is administered via injection under the skin.”
“When independent hospitals are acquired by multi-hospital health systems, they experience boosts to profitability and efficiency, according to a new study published in the Journal of Political Economy Microeconomics this week.
“Acquired hospitals saw profitability increase by about $14 million per year, on increased consumer prices and cuts to nonclinical staff.
“However, when corporate-owned hospitals are acquired by other health systems, they do not experience similar efficiency gains, the study found, suggesting there is likely a limit to how much consolidation can benefit hospital performance.”
“Today, the Centers for Medicare & Medicaid Services (CMS) announced that average premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program will remain stable in 2025. Average premiums are projected to decline in both the MA and Part D programs from 2024 to 2025. Enhancements adopted in the 2025 MA and Part D Final Rule, as well as payment policy updates in the 2025 MA and Part D Rate Announcement, support this stability and increase enrollee protections and access to care for people with Medicare. In addition, the Inflation Reduction Act is reducing prescription drug costs and delivering more comprehensive benefits than ever before, including an annual $2,000 cap on out-of-pocket drug costs. CMS is committed to ensuring these programs work for people with Medicare, that they have access to strong and stable choices, and that they have the information they need to make informed choices about what is best for them.
“CMS is releasing this key information, including 2025 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2024, to December 7, 2024, to help people with Medicare determine the best Medicare coverage option for their health care needs. * * *
“For more information on MA and Medicare Part D offerings for 2025, view the fact sheet.
“To view the premiums and costs of 2025 Medicare Advantage and Part D plans, please visit https://www.cms.gov/medicare/coverage/prescription-drug-coverage. Select the 2025 landscape source file in the downloads section of the webpage. This year, CMS has combined the Landscape files into one file, instead of five individual files as was the case historically, and made additional enhancements to improve the end-user experience and simplify the format. The accompanying readme file at the link above provides important notes about the format and file columns.
Beckers Payer Issues offers ten notes on the CMS press release.
The American Hospital Association News lets us know,
“The Health Resources and Services Administration Sept. 27 sent a final warning letter to Johnson & Johnson urging the company to inform the agency by Monday, Sept. 30 that it would halt its proposed 340B rebate model scheduled to go into effect next month.
“As outlined in HRSA’s September 17, 2024, letter, if J&J proceeds with implementing its rebate proposal without Secretarial approval, it will violate section 340B(a)(1) of the Public Health Service Act,” HRSA wrote today. “If J&J has not notified HRSA that it is ceasing implementation of its rebate proposal by September 30, 2024, HRSA will begin the process outlined in J&J’s Pharmaceutical Pricing Agreement related to terminating the agreement. In addition, if J&J moves forward with implementation of its rebate proposal, HRSA will initiate a referral to the HHS Office of Inspector General pursuant to 42 U.S.C. § 256b(d)(1)(B)(vi).”
“Postmaster General Louis DeJoy is telling lawmakers the Postal Service is ready to handle a high volume of mail-in ballots ahead of Election Day.
“DeJoy told members of the House Appropriations Committee on Thursday that USPS has a “track record of success” delivering ballots.
“In 2020, at the height of the COVID-19 pandemic, USPS delivered 99.89% of ballots from voters to election officials within seven days.
“That year, when USPS delivered a “historically high number of ballots,” DeJoy said they accounted for just 0.1% of its annual mail volume.
“We will be even better prepared for 2024,” DeJoy said. “Our network is designed to readily handle a surge in mail volume, just like we do every election and holiday season.”
“DeJoy recommends voters mail their ballots early, at least seven days before their state’s election deadline.”
From the public health and medical research front,
The Centers for Disease Control and Prevention announced today,
“Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated.
“COVID-19
“There are continued signs of declines in COVID-19 activity in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are decreasing. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
“Vaccinations to prevent fall respiratory virus have started for the 2024-25 respiratory illness season with 4.5% of adults 18 years and older reporting receipt of the updated 2024-25 COVID-19 vaccine and 9.6% reporting receipt of an influenza vaccine. Among adults 75 years and older, 34.0% reported ever receiving an RSV vaccine. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
Wastewater levels for COVID-19 remain high but low for RSV and influenza. Of flu cases identified through specimens testing, the H1N1 strain accounts for 53.5% of cases, H3N2 for 46.5%, and influenza B for 1.2%. Influenza test positivity for the week ending on September 21 was 0.6%.
“A new study on COVID-19’s effects on US infants notes that the proportion of hospitalized babies of mothers vaccinated during pregnancy plunged from 18% in October 2023 to 4% in April 2024, underscoring the need for increased vaccine uptake.
“And another report estimates that unexpected infant deaths jumped as much as 14% in 2021 relative to pre-pandemic totals.”
“A pair of new studies on COVID-19 antiviral drugs suggest that resistance mutations that emerge after treatment with nirmatrelvir-ritonavir (Paxlovid) or remdesivir (Veklury) are rare and that almost a third of US adults have never heard of Paxlovid.”
The American Hospital Association News points out,
“The National Foundation for Infectious Diseases Sept. 25 released a survey showing that less than one in five U.S. adults are concerned about themselves or a family member getting a respiratory virus infection this fall and winter. The survey, conducted in August, found that 20% are concerned about COVID-19, 17% are concerned about flu, 17% are concerned about pneumococcal disease and 16% are concerned about respiratory syncytial virus. Additionally, it found that while 67% of adults agree that an annual flu vaccination is the most effective way to prevent flu-related hospitalizations and deaths, 45% said they do not plan to or are unsure if they will receive a flu vaccine this season, and 38% said they definitely plan to. Regarding COVID-19, 26% of adults said they will definitely get an updated vaccine. Among those for whom a vaccine is recommended, only 21% said they will definitely get an RSV vaccine and 24% said they would definitely receive one against pneumococcal disease.”
“A possible cluster of bird-flu infections in Missouri has grown to include eight people, in what may be the first examples of person-to-person transmission in the United States, the Centers for Disease Control and Prevention reported on Friday.
“If confirmed, the cases in Missouri could indicate that the virus may have acquired the ability to infect people more easily. Worldwide, clusters of bird flu among people are extremely rare. Most cases have resulted from close contact with infected birds.
“Health officials in Missouri initially identified a patient with bird flu who was hospitalized last month with unusual symptoms. The patient may have infected one household member and six health care workers, all of whom developed symptoms, according to the C.D.C.
“Investigators have not yet confirmed whether any of those seven individuals were infected with the virus, called H5N1, leaving open the possibility that they had Covid or some other illness with flulike symptoms.”
“Major heart defects are more common — but still rare — in babies conceived through certain fertility treatments, including in vitro fertilization, researchers reported on Thursday in the largest study of its kind.
“The research, which included medical records of more than seven million Nordic children, also bolstered evidence that I.V.F. is associated with a small but significant uptick in birth abnormalities.
“It’s an increased risk, but the absolute risk is very small,”said Dr. Ulla-Britt Wennerholm, the senior author of the paper and a professor of obstetrics and gynecology at the University of Gothenburg in Sweden.
“I think that’s a reassuring finding, actually.”
“The study focused on children born between 1984 and 2015 in Denmark, Sweden, Norway and Finland as a result of a class of fertility treatments called assisted reproductive technology, the most common of which is I.V.F.”
“Prostate cancer presents a tricky screening challenge. Catching it early could mean dodging a painful journey with advanced cancer. Yet a sizable majority of prostate cancers are “indolent” — slow growing tumors that most likely would never metastasize during the patient’s lifetime, and whose treatment would do more harm than good.
“Experts have long clashed over these considerations, with some arguing that the harms of PSA testing outstrip the benefits and others adamant that lives are saved with screening. The balance may now be shifting as researchers and physicians find methods that reduce the harms of screening, in particular with the use of MRI. A new study published in the New England Journal of Medicine on Wednesday showed using MRI scans can reduce unnecessary diagnosis and treatment of screen-detected prostate cancer by more than half.
“That result should be a reason for experts to rethink prostate cancer screening guidelines with MRI in mind, according to Jonas Hugosson, a professor of urology at the University of Gothenburg in Sweden and the study’s lead author. “In my opinion, this is the last piece of the puzzle to have real evidence that the benefits of prostate screening exceed the harms on a population level,” he said. “This paper is the message to healthcare authorities around the world to look over recommendations for men.”
“That may be easier said than done, other experts said. There may not be enough MRI infrastructure to support a prostate screening program requiring the scans.”
STAT News also calls attention to the fact that the “Sickle cell community scrambles to find safe plan after a drug is pulled from the market. Pfizer’s abrupt decision left many feeling they had no guidance on what to do next.”
“The vast majority of Americans with the disease are Black, its research long neglected, its care long suffused with racism and stigma. “There’s a lot of people in the sickle cell warrior community where they felt like, historically, they’ve been guinea pigs,” said Habib.
“This week, the feeling can cut two ways, in the sense that some patients may have been prescribed a medication that may have been dangerous, and in the sense that some are losing something helpful with no warning. It wasn’t just the news about a drug that some people had been taking daily for years; it was how it was rolled out, with little warning or guidance. One patient advocate said she was too devastated to comment. Another was so shocked she didn’t believe it at first.
“You know I’m just worried about everyone’s safety. I want to make sure no one is having extreme side effects,” said Quannecia McCruse, president and CEO of the Sickle Cell Association of Houston, who had considered quitting her Oxbryta cold turkey this week because she’s done so before and had no issues. Yet she also found the whole thing weirdly precipitous, and wondered if the drug might still end up in the medicine cabinet — perhaps for a more specific group. “Not one sickle cell person is like another.”
The New York Times identifies five common signs of dementia other than memory loss
“Women are increasingly using guns to die by suicide in the United States, challenging long-held assumptions that they will usually resort to less lethal means, according to data released on Thursday by the Centers for Disease Control and Prevention.
“Gun-related suicide is most often associated with men, largely because men are more likely than women to purchase guns and to die by suicide. But in 2020, gun-related suicides surpassed poisoning and suffocation for the first time among women and have continued to rise since then.
“Suicide attempts with guns are far more lethal than those by other means, and firearm injuries now account for more than half of all suicide deaths.
“The findings, drawn from federal health data, showed that in 2022, 20 out of every million women used a gun to die by suicide, up from 14 women in 2002. This marks a 43 percent increase. The report also found that suicide rates have risen among women over the past two decades.”
From the U.S. healthcare business front,
The Institute for Clinical and Economic Research follows up on yesterday’s FEHBlog post,
“The FDA approved Karuna Therapeutics’ xanomeline tartrate/trospium chloride (also known as KarXT) for schizophrenia yesterday.
“ICER’s Chief Medical Officer David Rind, MD, MSc stated:
“Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves. Among the important side effects of current treatments is weight gain leading to metabolic syndrome. This, in turn, places patients at risk for cardiovascular events and death. KarXT has a novel mechanism of action and, at least in the short run, does not seem to cause weight gain. This may lead to major health benefits compared with existing treatments, however current evidence on benefits and harms is limited.”
“As employers face rising costs, many are looking to rethink plan designs rather than emphasize shifting expenses to workers, according to a new WTW report. WTW released its 2024 Best Practices in Healthcare Survey on Thursday, which polled 417 employers representing 6 million workers. It found that these firms are expecting costs to balloon by 7.7% in 2025, compared to an increase of 6.9% in 2024 and 6.5% for 2023.
“Despite the increase, however, only 34% told WTW that they intend to shift those costs to employees by raising premiums. Twenty percent said they will push high-deductible health plans or account-based coverage to address costs.
“Instead, 52% said they intend to roll out programs that reduce total costs, and 51% said they would use plan designs and network models to steer workers to lower-cost and higher-quality providers.”
“On Thursday, September 26, 2024, the President signed into law:
“H.R. 9747, the ”Continuing Appropriations and Extensions Act, 2025,” which provides fiscal year 2025 appropriations to Federal agencies through December 20, 2024, for continuing projects and activities of the Federal Government.”
“Congress has again deferred Medicare reimbursement cuts of up to 15% for clinical laboratory tests with the passage Wednesday of a short-term government funding bill.
“The appropriations bill pushes back by one year the implementation of Medicare payment rates scheduled to take effect in January for about 800 lab services.
“We are pleased that Congress has delayed pending reductions, recognizing the harm repeated Medicare reductions would have on the nation’s health care system that relies on clinical laboratory testing every day to inform patient care,” Susan Van Meter, president of the American Clinical Laboratory Association, said in a Wednesday statement.”
Here are links on yesterday’s OPM’s 2025 FEHBP/FEDVIP premium announcement from Govexec, Fedweek and FedSmith. Govexec also reports, “Biden administration officials said that two nationwide insurers in the federal government’s employer-sponsored health care program [Blue Cross FEP and GEHA] will offer $25,000 worth of in vitro fertilization and other fertility treatments.
“Today, the U.S. Department of Health and Human Services (HHS) through the Advanced Research Projects Agency for Health (ARPA-H) announced funding for the Transforming Antibiotic R&D with Generative AI to stop Emerging Threats (TARGET) project, which will use AI to speed the discovery and development of new classes of antibiotics. This program is another action to support the United States’ longstanding commitment to combating antimicrobial resistance (AMR), from groundbreaking innovation to international collaboration. The U.S. is a global leader in the fight against AMR and has a demonstrated track record of progress in protecting people, animals, and the environment from the threat of AMR domestically and globally.”
From the public health and medical research front,
“Today, the U.S. Food and Drug Administration approved [Bristol, Myers, Squibb’s] Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.
“Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” said Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
BioPharma Dive offers an excellent explanation of the various factors affecting sales of this drug.
KFF Health News points out that “Deadly High Blood Pressure During Pregnancy Is on the Rise.”
“A New York residenthas died amid a nationwide listeria outbreak tied to Boar’s Head deli meat, the Centers for Disease Control and Prevention announced Wednesday, bringing the death toll to 10in the largest outbreak of the foodborne illness since 2011.
“The agency also reported two new hospitalizations associated with the outbreak. In total, 59 people have been hospitalized in 19 states since late May.
“Deaths have occurred in Illinois, New Jersey, New York, Virginia, Florida, Tennessee, New Mexico and South Carolina. In its latest update, the CDC noted that illnesses have started to decrease. The number of sick people is probably higher than the official case count, the agency said, since those who do not seek medical care are not tested for listeria.
“Boar’s Head identified the production process for liverwurst at its plant in Jarratt, Va., as the culprit for contaminating the meat. This month, the company announced it would indefinitely close the southern Virginia plant and permanently discontinue liverwurst.”
“Genetic mutations affect nearly all human diseases. Some genetic disorders such as cystic fibrosis are caused by mutations in a single gene that a person inherits from their parents. Other diseases can be caused by changes in multiple genes or from a combination of gene mutations and environmental factors. We still have a lot to learn about the complex ways that variations in our genes affect health and disease.
“Researchers investigating genetic disorders have primarily studied mutations that cause our cells to alter the makeup of proteins, like the most common mutations that cause cystic fibrosis. Less research has been done on alterations called synonymous mutations, which have been called “silent” because they don’t alter the makeup of proteins, leading scientists to long assume that these kinds of mutations don’t produce any noticeable differences in our biology or health. However, recent research has shown that synonymous mutations can lead to significant changes in a cell’s ability to survive and grow. A new NIH-supported study reported in Proceedings of the National Academy of Sciencessheds additional light on the impact of synonymous mutations and their effect on the way proteins are made.” * * *
“The researchers behind this study, at the University of Notre Dame in Notre Dame, IN, wanted to understand how synonymous mutations may affect how much protein is made and whether proteins are folded correctly in cells. Misfolded proteins are known to play roles in numerous diseases, including cystic fibrosis, Alzheimer’s disease, and some cancers. The study team, led by Patricia L. Clark, who received an NIH Director’s Pioneer Award in 2021 for this work, has shown that synonymous mutations in a particular gene in Escherichia coli(E. coli) bacteria can alter how the encoded protein folds as it is being made, by altering the rate at which cells produce each copy of the protein. The new research goes a step further and shows that silent mutations in one gene can affect the amount of protein produced from a separate, neighboring gene.” * * *
“This discovery in E. coli may have important implications for understanding the bacteria’s biology and evolution. Clark’s team continues to study this system to learn more. Their findings may also prove to have broader implications for biology, including for some genetic disorders. It’s an area that warrants more study and attention, to better understand the roles that synonymous mutations may be playing in genes and their effects on human health.”
“Scientists at the National Institutes of Health (NIH) and their colleagues have identified a gene responsible for some inherited retinal diseases (IRDs), which are a group of disorders that damage the eye’s light-sensing retina and threatens vision. Though IRDs affect more than 2 million people worldwide, each individual disease is rare, complicating efforts to identify enough people to study and conduct clinical trials to develop treatment. The study’s findings published today in JAMA Ophthalmology.
“In a small study of six unrelated participants, researchers linked the gene UBAP1L to different forms of retinal dystrophies, with issues affecting the macula, the part of the eye used for central vision such as for reading (maculopathy), issues affecting the cone cells that enable color vision (cone dystrophy) or a disorder that also affects the rod cells that enable night vision (cone-rod dystrophy). The patients had symptoms of retinal dystrophy starting in early adulthood, progressing to severe vision loss by late adulthood.
“The patients in this study showed symptoms and features similar to other IRDs, but the cause of their condition was uncertain,” said Bin Guan, Ph.D., chief of the Ophthalmic Genomics Laboratory at NIH’s National Eye Institute (NEI) and a senior author of the report. “Now that we’ve identified the causative gene, we can study how the gene defect causes disease and, hopefully, develop treatment.”
“Identifying the UBAP1L gene’s involvement adds to the list of more than 280 genes responsible for this heterogeneous disease.”
The U.S. Preventive Services Task Force posted a “Final Research Plan for Enhanced Risk Assessment for Cardiovascular Disease: Coronary Artery Calcium Scoring.”
From the U.S. healthcare business front,
The FEHBlog was surprised to read in Beckers Hospital Review that
Johnson & Johnson will discontinue upfront 340B drug rebates for certain hospitals, raising concerns among healthcare providers and advocacy groups. The proposed policy, set to take effect Oct. 15, would prevent certain hospitals from accessing 340B discounts for Stelara, used to treat plaque psoriasis, psoriatic arthritis and other conditions; and Xarelto, a blood thinner.
“While consumers give telehealth high marks for convenience, overall experience is fairly mixed, according to a new report.
“J.D. Power released its annual Telehealth Satisfaction Study on Thursday, and found patients overall gave a score of 730 out of 1,000 for direct-to-consumer telehealth platforms. Payer-provided telehealth earned a lower score of 708, which suggests patients encounter differences in quality and ease of access between providers.
“The study also found the highest satisfaction scores for people enrolled in Medicaid, those living in urban areas, millennials and Gen Zers. The lowest scores were among people enrolled in Medicare or commercial coverage, those living in suburban regions and members of the Boomer generation or older.”
McKinsey and Company explore “Reimagining healthcare industry service operations in the age of AI.”
KFF offers “A Snapshot of Sources of Coverage Among Medicare Beneficiaries” and tells us “Nearly 7 in 10 Medicare Beneficiaries Did Not Compare Plans During Medicare’s Open Enrollment Period.”
“Enrollees in the Federal Employees Health Benefits (FEHB) program are about to see the largest annual increase in their health insurance costs in at least a decade.
“Beginning in January, federal employees and annuitants enrolled in FEHB will pay 13.5% more, on average, toward their health care premiums, according to data the Office of Personnel Management released Wednesday.
“The significant premium increase for FEHB plan year 2025 follows a 7.7% jump for 2024, and an 8.7% increase in 2023. OPM said the increase reflects changes in the market over the last year, and generally aligns with other programs in the commercial market.
“The premium increases are due to the impact of price increases by providers and suppliers, increased utilization of certain prescription drugs and behavioral health spending,” OPM said. “Industry-wide cost pressures affect FEHB and PSHB rates similarly.” * * *
“Across the 42 health carriers for 2025, FEHB participants will see 64 plans and a total of 130 plan options.
“PSHB participants will, by contrast, have 69 plan options offered across 30 health carriers. That includes seven fee-for-service carriers and 23 health maintenance organizations (HMOs) available through the PSHB.”
Here is a link to OPM’s 2025 FEHB/PSHBP premiums website.
Federal Employees Health Benefits (FEHB)
“The 2025 biweekly maximum government contribution for most employees and annuitants (72% of the weighted average) is $298.08 for Self Only, $650.00 for Self Plus One, and $714.23 for Self and Family. The monthly maximum government contribution (72% of the weighted average) is $645.84 for Self Only, $1,408.33 for Self Plus One and $1,547.50 for Self and Family.
“For 2025, the biweekly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollments with a government contribution are $414.00, $902.78, and $991.99, respectively. The monthly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollments with a government contribution are $897.00, $1,956.02, and $2,149.31, respectively.”
Postal Service Health Benefits (PSHB)
“The 2025 biweekly maximum government contribution for most employees and annuitants (72% of the weighted average) is $286.09 for Self Only, $618.40 for Self Plus One, and $672.95 for Self and Family. The monthly maximum government contribution (72% of the weighted average) is $619.86 for Self Only, $1,339.87 for Self Plus One and $1,458.06 for Self and Family.
“For 2025, the biweekly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollment with a government contribution are $397.35, $858.89, and $934.65, respectively. The monthly program-wide weighted average premiums for Self Only, Self Plus One, and Self and Family enrollments with a government contribution are $860.93, $1,860.93, and $2,025.08, respectively.”
“In contrast to the large increases for FEHB and PSHB premiums, the average premium rate increases for the Federal Employees Dental and Vision Insurance Program (FEDVIP) will be relatively small in 2025.
“Premiums will rise for FEDVIP dental plans by 2.97% on average, while vision plans will go up by 0.87%, OPM said.
“FEHB and PSHB participants will both be able to select from seven dental carriers offering 14 nationwide plan options for 2025. There will also be 10 nationwide vision plans available nationwide across five different carriers next year.”
Here is a link to the OPM website with 2025 FEDVIP premiums.
“Congress passed legislation on Wednesday to fund the government into December and send more than $230 million in emergency funding to the Secret Service.
“Lawmakers had a deadline of Monday to pass new financing bills and avoid a government shutdown. The new legislation extends that deadline to Dec. 20 and funds the government at current levels until then.
“House Speaker Mike Johnson (R-La.) relied on support from Democrats — rather than just his own GOP majority — to approve the funding. The House earlier rejected a measure Johnson preferred that would have extended the deadline into March and included a new requirement to prove citizenship when registering to vote in federal elections. The Senate passed it very quickly later Wednesday evening on a bipartisan basis.
“The short-term spending bill, also known as a continuing resolution or CR, will set up a frenzied year-end period to pass annual spending bills before the next president takes office.”
“Democrats on Wednesday launched a legislative push to extend federal subsidies that defray the cost of health insurance for millions of Americans. The effort tees up another Affordable Care Act fight that could stretch into next year — and perhaps challenge the next president.
“Sens. Jeanne Shaheen (D-N.H.) and Tammy Baldwin (D-Wis.) introduced legislation to make permanent tax credits that lower the cost of plans sold through the Affordable Care Act. Rep. Lauren Underwood (D-Ill.), who helped craft the initial legislation to create the expanded tax credits almost four years ago, introduced companion legislation in the House. Senate Majority Leader Charles E. Schumer (D-N.Y.) and House Minority Whip Katherine Clark (D-Mass.) joined Shaheen and Underwood at a news conference to unveil the legislation Wednesday.
“Congress must “take swift action at the first legislative opportunity to make the tax credits permanent,” Underwood said in an interview.”
“The Senate voted unanimously Wednesday to hold Steward Health Care CEO Ralph de la Torre in contempt of Congress, asking the Justice Department to pursue criminal charges against the hospital executive for failing to comply with a congressional subpoena.
“It is the first time since 1971 that the Senate has asked the Justice Department to pursue criminal contempt charges against an individual, lawmakers said. Steward, a for-profit company that owns about two dozen hospitals across the country, is engaged in bankruptcy proceedings and has been seeking to sell its hospitals.
“Community leaders and health workers in states served by Steward’s facilities have blamed the company’s leaders for extravagant paydays even as hospitals struggled to meet mortgage payments and cover other expenses. The Justice Department also has been investigating the company regarding allegations of fraud.”
“About 43% of Medicare beneficiaries who received remote patient monitoring didn’t get allthree components of the service, including the monitoring device, education and setup, and treatment management.
“Medicare doesn’t have critical information about the remote monitoring it pays for — like what data is being monitored, what types of devices beneficiaries use and which provider ordered the service — complicating oversight efforts, according to the OIG.”
“The Biden administration has finalized a rule targeting fraudulent billing in Medicare’s largest value-based care program, after concerning reports of spiking spending on urinary catheters.
“The anomalous billing had the potential to hurt accountable care organizations, or ACOs, in the Medicare Shared Savings Program by impairing their ability to capture shared savings. ACOs are groups of providers that assume responsibility — and occasionally, financial risk — to care for a group of patients.
“However, the CMS’ rule finalized Tuesday shields ACOs by excluding payments for suspect catheter billing codes from the 2023 performance year.”
“Medicare will begin compensating hospitals for providing quality data to support “age-friendly” medical care as the government seeks to bolster private sector efforts to adapt to the aging population.
“Starting in January, hospitals will report on a slew of measures to assess whether they are improving care for older patients in emergency departments, operating rooms and other settings. The Centers for Medicare and Medicaid Services laid out the new policy in the Medicare Inpatient Prospective Payment System final rule for fiscal 2025, which it published last month.”
“Today, the 988 Suicide & Crisis Lifeline announced that the process to start routing cellular phone calls to 988 contact centers based on the caller’s approximate location, versus by area code — known as “georouting” — began last week with two major U.S. wireless carriers that combined make up about half of all wireless calls to 988. The U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and the 988 Network Administrator, Vibrant Emotional Health, have been working with all of the major U.S. cell phone carriers for more than a year to improve call routing to 988 so that callers on a cell phone can be connected more locally to centers that are better equipped to provide nearby resources and services.”
From the public health and medical research front,
“Nearly 1 in 3 Americans may have an undiagnosed iron deficiency, a problem that can lead to fatigue, brain fog and difficulty concentrating, a new study suggests.
“An analysis of data from more than 8,000 adults in the U.S. revealed that 14% had low iron blood levels, a condition known as absolute iron deficiency, while 15% had the right iron levels but their bodies couldn’t use the essential mineral properly, known as functional iron deficiency, according to the report published Tuesday in JAMA Network Open.
“Doctors don’t typically screen adults for iron deficiency, which is why the condition has been overlooked in many people.
“The researchers weren’t surprised at the results, however. There had been hints in other studies suggesting iron deficiency might be more widespread than doctors assume.”
“You might think that people would be lining up to get a highly effective vaccine for a relatively common disease that can cause such pain, but that’s not the case. The CDC recommends two doses of Shingrix for everyone 50 and older, yet only 18.6 percent of people in the United States in this age group have received at least one dose, according to CDC data from 2021.
“Jonathan Lowe says many people don’t understand how bad shingles can be.
“A television reporter and anchor in Charlotte, Lowe was diagnosed with shingles in March, and it took five months for him to fully recover and start anchoring a newscast again.”
The Wall Street Journal reports,
“Pfizer said it is voluntarily withdrawing all lots of its sickle-cell drug Oxbryta in all markets where it is approved, two years after acquiring its parent company Global Blood Therapeutic in a $5.4 billion deal.
“The drugmaker said Wednesday the decision is based on clinical data that now indicate the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle-cell patient population.
“Pfizer also said it has notified regulatory authorities about its latest findings about Oxbryta.”
“Adults with opioid use disorder who receive a higher daily dose of the opioid addiction treatment medication buprenorphine may have a lower risk of subsequent emergency department visits or use of inpatient services related to behavioral health (such as for mental health and substance use disorders) than adults receiving the recommended dose, according to an analysis funded by the National Institutes of Health (NIH). These findings suggest that higher buprenorphine doses could be more effective in managing opioid use disorder, which may be particularly relevant for improving treatment for those who use fentanyl, a major driver of the overdose crisis.” * * *
“These findings build upon accumulating evidence of the safety and efficacy of higher doses of buprenorphine. Studies have shown that more than 16 mg of buprenorphine is safe and well tolerated in people with opioid use disorder in emergency department and outpatient treatment settings, and that higher buprenorphine doses are associated with improved retention in treatment for opioid use disorder.”
The National Cancer Institute posted its Cancer Information Highlights on “GI Problems | Whole-Body Effects of Cancer | Potential Drug Targets.”
“Wall Street analysts greeted research announcements from Amgen about two immunology medicines with skepticism, saying the results suggest the drugs won’t pose a major challenge to market leaders.
“Amgen shared the top-line results from two Phase 3 trials during an investor presentation Tuesday. In the first, Amgen’s experimental rocatinlimab showed statistically significant improvement versus placebo for patients with atopic dermatitis, a form of eczema. In the second study, the drug Uplizna succeeded in treating generalized myasthenia gravis.
“But in research notes published following the presentation, analysts called the rocatinlimab results disappointing, saying the drug needed to show an especially high efficacy profile to counter safety concerns. The Uplizna findings, meanwhile, suggest Amgen has a viable second-line contender to treat myasthenia gravis but likely won’t threaten Argenx’s Vyvgart as a first-line choice, analysts said.”
“Medtronic and Siemens Healthineers have partnered to expand accessto pre- and post-operative imaging technologies for spine surgery, the companies said Wednesday at the North American Spine Society annual meeting.
“The firms will co-market Siemens Healthineers’ Multitom Rax X-ray imaging system and integrate it into Medtronic’s AiBLE suite of products for spine surgery.
“Skip Kiil, Medtronic’s president of cranial and spinal technologies, said in a statement the partnership should reduce variability and improve patient outcomes.”
“Roche launched the first test using the company’s technology to simultaneously detect up to 12 respiratory viruses.
“The launch, announced Tuesday, enables users of Roche’s Cobas 5800, 6800 and 8800 molecular diagnostic analyzers to test for pathogens including influenza A and B, RSV and the COVID-19 virus.
“The test is available for labs in countries that accept CE marks. Roche plans to file for 510(k) clearance in the U.S. in the fourth quarter. The company is targeting a respiratory molecular diagnostics market that it has predicted will be worth 1.7 billion Swiss francs by 2027, the equivalent of about $2 billion according to Wednesday’s exchange rate.”
Beckers Hospital Review identifies the 25 most expensive inpatient drugs, and tells us,
“A recent study from Harvard Medical School introduced TxGNN, an innovative AI tool designed to identify potential drug candidates for over 17,000 rare and neglected diseases.
“The research, published in Natural Medicine Sept. 25, found that TxGNN is nearly 50% more effective at identifying drug candidates and 35% more accurate in predicting contraindications than existing methods.
“The model links conditions to existing drugs, both FDA-approved and experimental, by leveraging data on DNA, clinical notes and gene activity. The model also offers insights into potential side effects, potentially speeding up the lengthy drug discovery process.
“TxGNN has been made available for free, encouraging its adoption by clinician-scientists in the search for new therapies.”
The New York Times reports that “Health care systems have been putting therapists’ progress reports online, much to the surprise (and anger) of some patients.”
“Starting in 2021, the federal government required all U.S. health care systems to share clinicians’ visit notes electronically, often referred to as open notes, as part of the 21st Century Cures Act. This includes therapy progress notes, which typically provide information about the client’s appearance and mood, a diagnosis, the treatment plan and any progress the client has made toward therapy goals.” * * *
“The 21st Century Cures Act allows clinicians to block notes in certain circumstances — for example if there’s a chance that the patient could become suicidal or homicidal after reading it.
“Steve O’Neill, a licensed clinical social worker and the director of behavioral health for OpenNotes, the organization at Beth Israel that has pushed for transparency between clinicians and patients, said that he temporarily blocked his notes from a patient who initially became psychotic and holed up in her apartment after reading them.
“There needs to be more research, Dr. Blease said, examining whether patients with severe mental illness could experience emotional harm or even self-injury after reading open notes.
“Dr. O’Neill has observed that some patients benefit from reading the notes alongside a clinician or in group therapy. It’s important that the patient not feel “ambushed,” he added.
Novo Nordisk’s top executive vowed to reopen price negotiations with insurers covering the company’s obesity and diabetes drugs at a congressional hearing on Tuesday in which lawmakers pressed Novo to lower the cost of the fast-selling medicines.
At the hearing, Novo CEO Lars Fruergaard Jørgensen said the company would consider new talks with insurers about the list prices of Wegovy and Ozempic if they follow through on a pledge to keep the medicines on their formularies. Novo has claimed that insurers have previously pulled coverage of its other medicines — such as insulins — once the company lowered list prices, because it resulted in less revenue for payers afterwards.
“If it works in a way where patients get access to a more affordable medicine, and we have certainty that it actually happens and not like when we lowered prices in prior rounds — that less people got access to our medicine — we will be positive towards it,” Jørgensen said.” * * *
[Senate HELP Committee Chair Bernie] Sanders [I VT] came to the hearing with, what he claimed, is a commitment from Cigna [Express Scripts], UnitedHealth Group [/ Optum Rx] and CVS Health [/ Caremark] to commit to covering the two drugs even if lower list prices lead to lower rebates. The initiative for doing so was the difference in list and after-rebate prices for Wegovy and Ozempic in the U.S. compared to other countries.”
Here is a link to the Federal Trade Commission’s public administrative complaint against Express Scripts, Caremark, and Optum Rx over insulin rebates.
“The chair of the powerful Senate Finance Committee is pressing hospitals on their compliance with federal emergency care law amid mounting reports that patients who need lifesaving abortions are being turned away.
“Sen. Ron Wyden, D-Ore., sent letters to eight hospitals in states with abortion restrictions on Monday, asking about policies and procedures they have in place around the Emergency Medical Treatment and Active Labor Act, or EMTALA.
“Wyden also asked for a list of personnel involved in deciding when terminating a pregnancy is the appropriate course of treatment, and what legal and human resource support is offered to them by the hospital.”
CMS has created a website for its new civil monetary penalty program applicable to Section 111 reporting that will take effect on October 5, 2024, and will hold a compliance webinar on October 15, 2024, at 1 pm ET.
“Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), announced actions to increase the supply of mpox vaccine, supporting the U.S. Government commitment to make over a million combined doses of mpox vaccines available to the global mpox response. This is the largest international donation of the JYNNEOS mpox vaccine to date, which just received regulatory approval from WHO last week.”
“Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced nearly $75 million to support health care services in rural America. Funding will launch new opioid treatment and recovery services in rural communities, strengthen maternal health care in the South, and help rural hospitals stay open. HRSA Administrator Carole Johnson attended an event yesterday in Wilson, North Carolina, where she discussed the impact of this investment in rural health care.” * * *
“The Biden administration issued a final rule Tuesday designed to address suspicious billing for durable medical equipment that may have cost the Medicare program more than $2 billion.
“The problem involving urinary catheters has disproportionately affected accountable care organizations, the groups of doctors, clinicians, and hospitals that provide coordinated care for beneficiaries in traditional Medicare.
“After detecting the spike in billing in early 2023, the Centers for Medicare & Medicaid Services stopped payment on almost all of the claims and began an investigation.
“They found the activity “was attributed to a small group of durable medical equipment supply companies,” and “determined that the beneficiaries did not receive catheters and were not billed directly, physicians did not order these supplies, and supplies were not needed,” said a CMS fact sheet. Since then, the top 15 billers of suspicious catheter claims have had their Medicare enrollment revoked.
“The CMS rule (RIN 0938-AV20) excludes payments involving certain billing codes for durable medical equipment from calculations used to assess an ACO’s financial performance in 2023.”
From the public health and medical research front,
“Obesity drug startup Metsera on Tuesday reported its first clinical data since launching in April with $290 million in venture funding. The data come from a Phase 1 trial of a drug, MET-097, that’s designed to have longer-lasting effects than injectable GLP-1 therapies like Novo Nordisk’s Wegovy. The results show that a weekly administration of the highest dose tested stimulated weight loss of 7.5% over 36 days, “matching, or potentially exceeding,” currently marketed and investigational anti-obesity medications, Metsera chief medical officer Steve Marso said in a statement. Metsera claimed the findings are supportive of once-monthly dosing and will start mid-stage trials in the fourth quarter, with results expected next year.”
“Cancer incidence trends in 2021 largely returned to what they were before the COVID-19 pandemic, according to a study by researchers at the National Institutes of Health (NIH). However, there was little evidence of a rebound in incidence that would account for the decline in diagnoses in 2020, when screening and other medical care was disrupted. One exception was breast cancer, where the researchers did see an uptick in diagnoses of advanced-stage disease in 2021. The study appears Sept. 24, 2024, in the Journal of the National Cancer Institute.
“A previous study showed that new cancer diagnoses fell abruptly in early 2020, as did the volume of pathology reports, suggesting that many cancers were not being diagnosed in a timely manner. To determine whether these missed diagnoses were caught in 2021, possibly as more advanced cancers, researchers from NIH’s National Cancer Institute (NCI) compared observed cancer incidence rates for 2021 with those expected from pre-pandemic trends using data from NCI’s Surveillance, Epidemiology, and End Results Program.”
“A full recovery in cancer incidence should appear as an increase over pre-pandemic levels (also known as a rebound) to account for the missed diagnoses. The researchers looked at cancer overall, as well as five major cancer types that vary in how they are typically detected: through screening (female breast and prostate cancer), due to symptoms (lung and bronchus and pancreatic cancer), or incidentally during other medical procedures (thyroid cancer).
“Cancer incidence rates overall and for most specific cancers approached pre-pandemic levels, with no significant rebound to account for the 2020 decline. However, in addition to an uptick in new diagnoses of advanced breast cancer in 2021, the data also provided some evidence of an increase in diagnoses of advanced pancreatic cancer. Also, new diagnoses of thyroid cancers in 2021 were still below pre-pandemic levels.
“The researchers concluded that 2021 was a transition year that was still affected by new variants and new waves of COVID-19 cases, which continued to impact medical care. They said the findings highlight the need for ongoing monitoring to understand the long-term impacts of the pandemic on cancer diagnoses and outcomes.”
“The US government plans to make more at-home Covid-19 tests available for free this month as the country heads into respiratory virus season with high levels of the coronavirus already circulating.
“Each household will be able to order another round of four free at-home test kits starting at the end of September at COVIDTests.gov.
“More than 900 million test kits have been delivered directly to US residents through the COVIDTests.gov program, according to the US Department of Health and Human Services.
“COVID-19 testing can help you know if you have COVID-19 so you can decide what to do next, like getting treatment to reduce your risk of severe illness and taking steps to lower your chances of spreading the virus to others,” the agency said.
“This next set of tests – the program’s seventh round of distribution – will be able to detect currently circulating variants and can be used as people prepare for year-end holiday gatherings.”
The Washington Post reports that “Doctors and patients struggle with starting and stopping GLP-1 medications with little guidance.”
“The FDA is having second thoughts about the broad labels it has granted PD-1 inhibitors in newly diagnosed stomach cancer, questioning whether restrictions should be placed on products from Bristol Myers Squibb and Merck & Co. plus a stomach cancer hopeful from BeiGene.
“In a briefing document prepared for an Oncologic Drugs Advisory Committee meeting slated for Thursday, the FDA suggested that PD-1 inhibitors may not be suitable for certain patients with HER2-negative gastric cancer who have low PD-L1 expression, even though these immunotherapies have shown life-extension benefits in broad study populations.”
“An EY report prepared for the AHA shows that tax-exempt hospitals and health systems delivered $10 in benefits to their communities for every dollar’s worth of federal tax exemption in 2020, the most recent year for which comprehensive data is available. It represents an increase from $9 in benefits from the prior year despite efforts in battling the COVID-19 pandemic.”
“Prudential Financial is re-entering the U.S. stop-loss insurance market, targeting employers with at least 100 employees, offering coverage for medical, prescription drug, dental, vision, and short-term disability claims, BenefitsPro reports. Prudential aims to leverage its experience under the leadership of Jessica Gillespie, who is head of Prudential’s group insurance products. The stop-loss market has seen significant price hikes, with some competitors dissatisfied with their financial outcomes.”
“Health insurance companies are increasingly covering prescriptions written by pharmacists as states expand pharmacists’ prescribing authority through “test to treat” legislation, Forbes reports. This shift aims to improve access to medications amid a shortage of primary care physicians. Major insurers like Cigna and Blue Cross and Blue Shield of Illinois are adapting their coverage policies accordingly.”
“Every day, patients send hundreds of thousands of messages to their doctors through MyChart, a communications platform that is nearly ubiquitous in U.S. hospitals.
“They describe their pain and divulge their symptoms — the texture of their rashes, the color of their stool — trusting the doctor on the other endto advise them.
“But increasingly, the responses to those messages are not written by the doctor — at least, not entirely. About 15,000 doctors and assistants at more than 150 health systems are using a new artificial intelligence feature in MyChart to draft replies to such messages.
“Many patients receiving those replies have no idea that they were written with the help of artificial intelligence. In interviews, officials at several health systems using MyChart’s tool acknowledged that they do not disclose that the messages contain A.I.-generated content.
“The trend troubles some experts who worry that doctors may not be vigilant enough to catch potentially dangerous errors in medically significant messages drafted by A.I.”
The House of Representatives and the Senate are in session this week for Committee business and floor voting. The members of Congress hit the campaign trail next week until they return to Capitol Hill in November following the national election for a lame duck session.
“In its ongoing commitment to support women’s health, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), today launched an innovative grant program to provide almost $9 million to improve women’s health coverage and access to critical health benefits. These funds may be used to develop activities and launch educational campaigns to address disparities in access to reproductive health care and maternal health outcomes – many of which often result from challenges women face when trying to access information about available benefits or coverage, including for contraception and other family planning services. The Expanding Access to Women’s Health program grantees include the District of Columbia and the following 14 states: Arkansas, Colorado, Hawaii, Massachusetts, Maine, Mississippi, Nebraska, New Hampshire, New Jersey, New Mexico, Pennsylvania, Vermont, Washington, and Wisconsin.”
“Fewer hospitals will face high readmissions penalties in 2025 as rates of reimbursement cuts stabilize for providers.
“It is the third consecutive year in which the percentage of hospitals assessed penalties of 1% or more moderated, according to preliminary data released Friday by the Centers for Medicare and Medicaid Services. Penalties reduce the Medicare fee-for-service payments CMS makes to hospitals.
“For fiscal 2025, the number of hospitals included in the agency’s Hospital Readmissions Reduction Program is the lowest it has been in five years, with 100 fewer facilities participating than in fiscal 2021.
“The hospital readmissions performance period for fiscal 2025 pulls in claims from July 2020 through June 2023. The report is based on a rolling three-year time period, so the most recent one is the first to only include data generated after the start of the COVID-19 pandemic.”
“For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet.
“Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed (PDF) a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February [2024 for lack of standing and proper venue], punting the complaint back to a lower Texas court.
“Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease treatment.
“The FDA cleared Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). The med is the first IL-17A/F inhibitor approved to treat the three indications, UCB noted in a press release.”
From the public health and medical research front,
“About 37 percent of Gen Z men in the United States do not have an established primary care provider, according to a recent survey from the Cleveland Clinic. The survey, conducted this summer, involved 1,000 American men 18 or older living in the continental United States.
“Researchers assessed how different generations of men responded to questions about their health and health care, including whether they obtain yearly physicals, get screened based on doctors’ recommendations, and avoid smoking or vaping.
“The 37 percent of adult Gen Z men (born from 1997 through 2005) without a regular primary care provider compared with 27 percent of millennials (born from 1981 through 1996), 17 percent of Gen X respondents (1965 to 1980) and 7 percent of baby boomers and older (born before 1965).
“Nearly all the respondents said living a healthy lifestyle was a top priority, and 87 percent were concerned about how their current health habits would affect their future health. Millennials and adult Gen Zers were more likely to take care of their mental health (59 percent) than Gen X and boomers (53 percent), according to the survey.”
Consumer Reports, writing in The Washington Posts, offers tips on how to alleviate hip pain.
“Of the roughly 15 million Americans who tried to quit smoking in 2022, 5 in 6 failed. It’s a jarring statistic — and an indictment of the treatment options for an addiction that kills 480,000 people in the U.S. each year.
“The smoking-cessation drugs on the market don’t work well for the majority of people, and they come with side effects and reputations that keep some smokers from ever trying them. Despite this, there hasn’t been a new class of drug approved for the condition in nearly two decades.” * * *
“Chantix increases smokers’ success at quitting when compared to a placebo — but for every 100 people who use it, just 21 to 25 successfully stop, a recent meta-analysis found. It’s also associated with a raft of side effects, ranging from nausea to vivid dreams. Chantix, also known by its chemical name, varenicline, went generic in 2021 and can be purchased without insurance for roughly $68 for a one month supply, according to GoodRx.” * * *
“In 2019, GlaxoSmithKline wrote to the FDA urging the agency to take several steps that would align its approach toward regulating NRT products with other nations’. Specifically, the drugmaker requested that the agency embrace a “Reduce to Quit” approach, whereby smokers are encouraged to use products like nicotine gum as they gradually reduce their cigarette consumption.
“While the FDA has said it is open to this approach, which is used in countries like Germany, Canada, and the United Kingdom, the agency issued a guidance last year instructing drugmakers they would need to conduct a trial to evaluate the proposed regimen. GSK has warned that the need for another study “will make it less likely for innovator companies to pursue this indication in the U.S.”
“A new KFF analysis examines the recent decline in opioid overdose deaths, with a focus on how trends vary by age, race, gender and state.
“Provisional data from the Centers for Disease Control and Prevention show a 20% decline in deaths during the latter half of 2023 compared to the same period from the previous year.
“In the second half of 2023, White people saw the largest decline (-14%) in opioid overdose deaths while declines among Black people were about half that (-6%), compared to the same period the year before.
“All age groups experienced declines in opioid overdose deaths except one. Among people 65 and older, opioid deaths rose by 9% percent in late 2023, with factors such as low detection of substance use concerns potentially playing a role.
“In three-quarters of states, opioid deaths declined in the last six months of 2023 compared to the same period in 2022. In 2023, opioid death rates were the highest in West Virginia, Washington D.C. and Delaware, while states with the lowest opioid death rates included Nebraska, South Dakota and Iowa.
“Newer provisional and partial data for the first quarter of 2024, which is not included in this analysis, point to a continuation of the overall downward trend in opioid overdose deaths through early 2024.”
“Employers expect prescription drug costs to increase an average of 8% in 2025, making prices the highest they’ve been in 15 years, according to a news release published yesterday. Data was taken from the results of the 2025 Segal Health Plan Cost Trend Survey, an annual survey of managed care organizations, health insurers, prescription drug benefit managers (PBMs) and third party administrators (TPAs). Price inflation is the biggest factor on medical costs.
“Respondents predict that the highest rates will be reflected in all outpatient prescription drugs with an 11.4% increase, up from last year’s projected rate of 9.9%, calculated before PBM rebates. Outpatient prescription drugs trends are affected by factors such as drug price inflation, direct-to-consumer advertising and a changing drug mix.
“The increased use of drugs with the glucagon-like peptide 1 (GLP-1s) is a driving force in drug prices, due to their effectiveness in treating both type 2 diabetes and obesity, the survey reports. In 2023, obesity management was the top medical condition driving costs at 255.3%, followed by migraines at 31.4%.”
“What began as a dispute between two health tech companies over healthcare data exchange practices has now led to a federal lawsuit alleging antitrust violations.
“Venture-backed health tech company Particle Health filed an antitrust lawsuit against Epic in the Southern District of New York alleging that the electronic health records (EHR) giant is trying to muscle out competition in the payer platform market.
“The 81-page lawsuit (PDF), filed today [in the U.S. District Court for the Southern District of New York], alleges Epic engaged in monopolistic, anti-competitive practices, using its “power over EHRs to expand its dominance into the fledgling market for payer platforms,” according to the lawsuit, which was reviewed by Fierce Healthcare.
“Particle Health argues in its federal complaint that Epic has not only engaged in anticompetitive behavior but has purposefully blocked the exchange of patient information.
“In an emailed response to Fierce Healthcare, an Epic spokesperson said Particle’s claims are baseless.”
“Stryker has struck its fourth takeover in as many months, acquiring Nico Corporation to add minimally invasive solutions for brain tumor removal and stroke care to its portfolio.
“Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue. The company received clearance for a device that allows visualization of the surgical field during brain surgery in 2012 and has since expanded its portfolio.
“Stryker will slot the products into a neurocranial business that reported U.S. organic sales growth of almost 11% in the second quarter. Specifically, the devices will form part of a neurosurgical unit that Stryker called out as a growth driver in the fourth quarter of 2023. Stryker did not disclose the terms of the deal.”
“House Republican leaders on Sunday unveiled a bipartisan spending deal that would keep the government open for three more months and give the Secret Service an extra $231 million to help the agency to protect presidential candidates during the final hectic weeks of election season.
“Secret Service officials have faced questions on whether a lack of resources contributed to the security lapses that enabled a gunman to shoot Republican presidential nominee Donald Trump in the ear during a campaign rally in Butler, Pa., in July. Secret Service agents stopped a second apparent assassination attempt on Trump at his Florida golf course last weekend.
“The additional money wouldn’t be available until the agency transmits a report on the first assassination attempt to a bipartisan task force investigating the incident. It would also give Secret Service officials the flexibility to move around money within the agency to accommodate demand through the end of the year. Leaders of both parties and President Biden have said that they are open to sending additional money to the agency.”
“Legislation to repeal the Windfall Elimination Provision and the Government Pension Offset is nearing the finish line in the House.
“Just over a week after it was filed, a discharge petition for the Social Security Fairness Act has reached the 218-signature threshold needed to force the bill to a floor vote.”
“Repealing the government pension offset and windfall elimination provisions would benefit those affected by those two Social Security reductions—including current and future federal retirees under the CSRS system—by a total of $196 billion over 10 years, says a cost estimate for Congress.
“But that also means passage would increase costs by that much to that already financially troubled system, the Congressional Budget Office said in an estimate whose price tag may complicate the current push to enact that long-standing proposal this year.”
The new mental health parity rule has been published in a complete and more compact form in the Federal Register.
From the public health and medical research front,
“A second health worker who cared for a person hospitalized in Missouri with H5N1 bird flu developed mild respiratory symptoms but was not tested for influenza, the Centers for Disease Control and Prevention reported on Friday.
“The CDC said Missouri health officials didn’t learn that the health worker had symptoms until after the individual had recovered, too late to run a diagnostic test.
“CDC is in close communication with the state of Missouri in its ongoing investigation into the positive H5N1 case there, including regarding the identification of an additional symptomatic close contact,” a spokesperson for the agency told STAT via email. “The finding does not change CDC’s assessment that the risk to the public remains low.” * * *
“The CDC said that the newly identified health worker will also be asked to submit a blood sample for testing. Asked if the health care workers have agreed to provide blood samples for antibody testing, Cox said: “We should know more next week.”
“Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy, said there could be another explanation for this health care worker’s illness. At the time the confirmed case was in hospital, there was a lot of respiratory illness, including high levels of Covid-19 activity.
“We’ll have to see what the serology shows,” Osterholm said.
“This news emerged as California announced it had found seven more infected dairy herds, bringing the number of affected farms in the state to 17, and the cumulative number of infected herds in the country to 215 in 14 states. The outbreak in cattle was first confirmed in late March.”
“Immigration status, structural racism and other social factors may contribute to disparities in cardiovascular health among Asian Americans, according to a statement prepared by a group of clinicians and researchers and published in the American Heart Association journal, Circulation.
“Asian Americans are less likely than White adults to have or die of heart disease, according to the Department of Health and Human Services Office of Minority Health. But researchers in the Circulation article note that cardiovascular health can vary widely between subgroups of Asian Americans and warn that combining different subgroups of people into a single “Asian” category could mask important differences.
“A 2021 Pew Research Center analysis of federal census data found that the number of Asian Americans grew 81 percent between 2000 and 2019, making it the nation’s fastest-growing racial group. Yet the term includes people from different subgroups, including Chinese, Indian, Filipino, Vietnamese, Korean and Japanese Americans.”
“Roche’s antiviral drug Xofluza reduced influenza transmission among household contacts in a large Phase 3 study, the company said Wednesday.
“Treatment with a single dose of Xofluza within 48 hours of symptom onset lowered the likelihood an infected person passed on the virus to other individuals within the same household. Roche didn’t disclose detailed results in its press release.
“Xofluza is currently approved to treat flu symptoms and prevent infections after exposure to the virus. The new data bolster its benefits and, according to Roche, represent the first time an antiviral drug has reduced transmission of a respiratory virus in a global Phase 3 study.”
MedPage Today discusses how GLP-1 drugs have the potential to reduce healthcare costs in unexpected ways.
“Cardinal Health plans to acquire Integrated Oncology Network for $1.12 billion in cash.
“The transaction is subject to regulatory approval and expected to close later this year, a Cardinal spokesperson said.
“As part of the deal, Nashville, Tennessee-based Integrated Oncology would join Cardinal’s oncology practice alliance, Navista, and share resources for practice management services, analytics capabilities and artificial intelligence tools, according to a Friday news release.
“Integrated Oncology has more than 50 practice sites in 10 states and represents more than 100 providers, offering medical oncology, radiation, diagnostic testing and other services.
“Dublin, Ohio-headquartered Cardinal, a pharmaceutical distributor and medical product manufacturer, has about 48,000 employees operating facilities in more than 30 countries. In March, the company acquired multispecialty group purchasing organization Specialty Networks for $1.2 billion in cash.”
“Cigna is the latest health insurer to roll back its Medicare Advantage offerings next year, as the privately run Medicare plans look for ways to preserve profits amid higher costs from more seniors utilizing medical care.
“Cigna’s planned reductions will affect 36 plans in eight states, and include the insurer exiting at least three counties entirely, according to a notice to marketing agents published by Pinnacle Financial Services on Wednesday.
“However, the majority of those plans have low membership, and patients in most markets will have access to another Cigna MA plan, according to the notice.”
“Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday.
“The FDA has approved Sarclisa to be used in combination with bortezomib, lenalidomide and dexamethasone (VRd) to treat patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplant.
“With the expansion, Sarclisa stands to give Johnson & Johnson’s Darzalex some company in the indication. Since 2018, the J&J med has been the lone CD38 antibody approved for first-line myeloma. For that Darzalex approval, the FDA cleared the med to be paired with bortezomib, melphalan and prednisone, also for transplant-ineligible patients. That Darzalex regimen is considered outdated and not used very often these days.
“Before the latest FDA approval, Sarclisa-VRd was recently added to the National Comprehensive Cancer Network (NCCN) myeloma treatment guidelines as a preferred regimen for transplant-ineligible patients, along with VRd alone and a Darzalex-Rd combo. All three regimens bear the highest category 1 recommendation.
“We’re getting access to the biggest segment of this market, and we are leveling the playing field in a major class of drug,” Olivier Nataf, Sanofi’s global head of oncology, said in a recent interview with Fierce Pharma.”
The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs.
The agency’s administrative complaint alleges CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx steered patients toward higher priced insulin in order to bring in larger rebates from pharmaceutical manufacturers.
As a result, patients who weren’t eligible for the lower discounted price faced higher costs, the FTC alleges. Caremark, Express Scripts and Optum Rx together control about 80% of U.S. prescriptions.
The FTC has decided to try the case in the FTC’s administrative court, instead of a federal district court. Any appeal would be taken to a federal circuit court of appeals, typically the D.C. Circuit.
“CVS Caremark in a statement said it had worked to drive down insulin prices by creating new formulary options and negotiating discounts on behalf of clients. It pointed to a program available to patients at its network pharmacies offering lower-cost insulin.
“Any action that limits the use of these PBM negotiating tools would reward the pharmaceutical industry and return the market to a broken state, leaving American businesses and patients at the mercy of the prices drugmakers set,” a spokesperson said in the statement.
“Cigna Chief Legal Officer Andrea Nelson refuted the FTC’s allegations and reiterated the role PBMs such as Express Scripts play in the healthcare system. She said the case could lead to higher drug prices.
“Express Scripts intends to vigorously defend itself to protect our ability to lower drug costs for the thousands of clients and the millions of Americans we serve,” Nelson said in a statement.
“An OptumRx spokesperson said in a statement its negotiations with drugmakers and other actions have led to lower insulin costs for members.
“This baseless action demonstrates a profound misunderstanding of how drug pricing works,” the spokesperson said.”
CMS posted the presentation from the agency’s September 10 webinar about group health plan Section 111 reporting.
“The Medicaid unwinding is coming to a close, and a new analysis from KFF finds that while many people have lost coverage during this period, enrollment remains above pre-pandemic levels.
“The report estimates that more than 25 million people were disenrolled as part of the Medicaid redeterminations, while more than 56 million renewed coverage successfully. However, while millions have lost coverage, there are about 10 million more people enrolled in Medicaid and the Children’s Health Insurance Program (CHIP) compared to the start of the COVID-19 pandemic.
“KFF found that most states completed the redeterminations with higher enrollment than they reported in February 2020. In seven states, enrollment was 30% above pre-pandemic levels.
“Also playing a role is the fact that five states—Missouri, Nebraska, North Carolina, Oklahoma, and South Dakota—expanded their Medicaid programs since the pandemic began, COVID-19 said.
“There have always been people eligible for Medicaid but not enrolled, as well as people who get dropped from Medicaid for failing to complete regular renewal processes,” the researchers wrote. “During the unwinding period, many states took steps to improve their renewal systems, leading to fewer people getting dropped even though they remain eligible.”
From the public health and medical research front,
The Centers for Disease Control and Prevention announced,
“Seasonal influenza and RSV activity are low nationally and COVID-19 activity is decreasing in most areas.
“COVID-19
“There are continued signs of declines in COVID-19 activity in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are decreasing. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
“Vaccinations to prevent fall respiratory virus have started for the 2024-25 respiratory illness season with 2.8% of adults 18 years and older reporting receipt of the updated 2024-25 COVID-19 vaccine and 6.8% reporting receipt of an influenza vaccine. Among adults 75 years and older, 33.1% reported ever receiving an RSV vaccine. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.
In Covid news, The University of Minnesota’s CIDRAP adds,
“Test positivity for COVID was 13.5% last week, down from 14.9% the week before.
“Hospitalizations continue to decline but remain highest in seniors, followed by adults ages 50 to 64 and children younger than age 4 years.
“Emergency department visits dropped about 19% compared to the previous week and are now at low levels across much of the country.
“Deaths held steady, and provisional data show that the CDC received reports of 563 COVID deaths for the week ending September 14.
“Detections of SARS-CoV-2 in wastewater are still high nationally, according to CDC tacking. The highest levels remain in the West, followed by the Midwest and the South. However, all regions show downward trends.
‘The latest data from WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, show that detections are still high nationally and, in the Midwest, with no significant up or down trend over the past 3 weeks.”
“The U.S. is experiencing more than four times as many whooping cough cases compared with last year — a spike that some experts attribute to post-pandemic vaccine fatigue.
“With the increase in vaccine hesitancy that has been going on since the Covid-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” said Dr. Tina Tan, president-elect of the Infectious Diseases Society of America.
“Babies are given the DTaP vaccine, which helps protect against three diseases: pertussis, diphtheria and tetanus. The vaccine works well against diphtheria and tetanus, but is less effective over time for pertussis.
“Until next generation vaccines are developed, boosters are recommended about every 10 years, starting in the tween years, as kids start middle school.
“It’s the tweens and teens whose immunity against whooping cough has waned that are driving outbreaks in many states, experts say.”
“On Thursday, the CDC reported that 14,569 cases of whooping cough had been confirmed so far in 2024. That’s a significant increase over last year’s total of 3,475 cases.”
“The Food and Drug Administration on Friday authorized at-home use of FluMist, opening the door for needle-shy people to have easy access to a nasal spray vaccine that is potentially lifesaving.
“The approval will allow, for the first time, an alternative to the annual flu shot that parents and caregivers can give to children and that adults can use on their own outside of a health-care setting. It would still require a prescription and is expected to be available from an online pharmacy next fall.
“AstraZeneca, which makes the treatment, said it would start a FluMist Home website, where people can fill out a questionnaire that will be reviewed by a pharmacist before the treatment is shipped to a person’s home. The mist will remain available from prescribers as an in-office treatment. The current out-of-pocket cost for a dose is about $35 to $45 but may be less depending on insurance coverage.
“Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” said Dr. Peter Marks, director of the F.D.A.’s vaccine center, which authorized the at-home option.”
The American Hospital Association News points out,
Drug overdose deaths have dropped by 10% this year compared to last, according to data from the Centers for Disease Control and Prevention. This year also marked an annual decline in overdose deaths for the first time in five years. On Aug. 31, federal agencies awarded an additional $416 million to respond to the overdose crisis and support substance use treatment and recovery services. The AHA remains focused on supporting hospitals and health systems in reducing drug overdose deaths, including by providing resources to enhance opioid stewardship. Learn more from AHA’s Opioid Stewardship Hub.”
“Today, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children 2 years of age and older.
“Miplyffa is the first drug approved by the FDA to treat NPC. NPC is a rare genetic disease that results in progressive neurological symptoms and organ dysfunction. It is caused by changes in either the NPC1 or NPC2 gene, affecting the necessary transport of cholesterol and other lipids within a cell. As a result, these cells do not function as they should, ultimately causing organ damage. On average, individuals affected by this devastating disease only live for about 13 years.
“NPC is a serious disease that leads to enormous adverse impacts on patients and families. Despite extensive research efforts, there have not been approved treatments to meet the significant needs of patients,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM), in the FDA’s Center for Drug Evaluation and Research. “The first-ever approval of a safe and effective drug option for NPC will undoubtedly support the essential medical needs of those suffering.”
“A next-generation obesity drug candidate from Novo Nordisk produced modest weight loss, along with a higher rate of some psychiatric side effects like anxiety and sleep disturbances — results that pose a challenge to the pharma giant’s efforts to find novel obesity drugs that could extend its success from its blockbuster Wegovy.
“A Phase 2a trial tested monlunabant, a pill that inhibits CB1 receptors that Novo got through its acquisition of Inversago Pharma last year. Those on the lowest dose of 10 mg lost on average 6.4% of their weight at 16 weeks, compared with 0.6% in the placebo group, Novo said Friday. The study also tested higher doses of 20 mg and 50 mg, but Novo said “limited additional weight loss” was seen at these higher doses and did not disclose specific data.”
From the U.S. healthcare business front,
Beckers Hospital Review Becker’s has compiled “a list of 189 hospitals with a CMS five-star rating for care transitions” and identified the “top ranked hospitals for coronary bypass in the U.S., according to the WebMD Choice Awards.
“A price battle has broken out in the hot market for weight-loss drugs.
“Eli Lilly and Novo Nordisk, the pharmaceutical heavyweights selling the popular injections, are each dangling discounts to gain an edge and to induce health plans to pay up. The concessions are slashing as much as half off the price tags of the $1,000-plus-a-month medicines.
For people who pay out of pocket, Lilly recently introduced vials of its drug Zepbound that cost as little as $399 a month.
Price concessions are a new, major development in the burgeoning market for weight-loss drugs, after high prices and limited supplies led many health plans to refuse coverage and prompted some patients to turn to lower-priced but unapproved custom-made version.
“GE Healthcare has received 510(k) clearance for a tool designed to help clinicians assess people who may have Alzheimer’s disease, the company said Tuesday.
“The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to enable clinicians to determine the density of amyloid plaque in a patient’s brain from PET scans.Amyloid is a protein that, in Alzheimer’s, can clump up into toxic plaques in the brain. Scientists have linked the formation of those plaques to symptoms such as memory loss.
“Researchers developed the Centiloid scale, which Eisai and Eli Lilly used during the development of their recently approved Alzheimer’s drugs, to standardize amyloid imaging measures.
“Abbott ramps up Libre 3 production amid shortages. Some people are facing delays in filling prescriptions for the glucose sensor. Abbott expects to resolve the problem soon.” * * *
“Some people who use a Freestyle Libre 3 glucose sensor are facing delays getting their prescriptions filled.
“Abbott spokesperson Lindsy Delco said the delays are driven by strong demand for the Libre 3 sensors. The company is ramping up production, adding capacity to an existing manufacturing facility this month, and opening a new manufacturing facility later this year, she wrote in an email.” * * *
“If people are unable to get Libre 3 sensors through their pharmacy or mail order company, Delco recommended checking back in a few days to see if they have new supply.
“If there are prolonged delays, another option is to talk to a healthcare provider about switching to a prescription for Freestyle Libre 3 Plus, Delco said. The Food and Drug Administration cleared the newer version of the sensor last year. It has a 15-day wear time, instead of 14 days for the Libre 3. The Libre 3 Plus has supply at both pharmacies and mail-order companies, according to Abbott.”
The American Hospital Association (AHA) News tells us,
“Sens. Chuck Schumer, D-N.Y., Susan Collins, R-Maine, and Bob Casey, D-Pa., Sept. 11 introduced the SEPSIS Act, legislation which would task the Centers for Disease Control and Prevention with building on its current efforts addressing sepsis care. New efforts would include an education campaign about addressing sepsis in hospitals, improving pediatric sepsis data collection, sharing information with the Department of Health and Human Services on data collection, including the Centers for Medicare & Medicaid Services on sepsis quality measures, and the development and implementation of a sepsis outcome measure. The bill also includes a voluntary recognition program for hospitals which maintain effective sepsis programs or improve their programs over time.”
The University of Minnesota’s CIDRAP lets us know,
“A National Academies of Sciences, Engineering and Medicine report recommends five actions to transition the National Wastewater Surveillance System (NWSS)—developed as a response to the COVID-19 pandemic—to a forward-looking version for both endemic and emerging pathogens.
“The paper, released yesterday, is the second and final report by the Academies’ Committee on Community Wastewater-Based Infectious Disease Surveillance done at the behest of the Centers for Disease Control and Prevention (CDC).
“The CDC launched the NWSS with the US Department of Health and Human Services to centralize the detection and quantification of pathogen biomarkers that people shed into the sewer system.
“Whereas clinical laboratory testing tracks individual cases of infection, sampling and analysis at the wastewater treatment plant level (termed community-level wastewater surveillance) provide aggregate data from the homes, businesses, and other institutions that share a common sewer system,” the committee wrote.”
CMS has launched a public facing website and posted a consumer fact sheet about the Medicare Prescription Payment Plan which will take effect January 1, 2025.
Healthline offers a projection of 2025 IRMAA brackets applicable to Medicare Parts B and D coverage for higher income beneficiaries.
Tammy Flanagan, writing in Govexec, offers thirteen things to know about long-term care planning.
From the public health and medical research front,
The Centers for Disease Control and Prevention posted their weekly summary concerning respiratory illnesses in the U.S. today.
“Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
“COVID-19
“COVID-19 activity remains elevated nationally, but there are continued signs of decline in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
“National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
“Someone who lived with a Missouri resident infected with bird flu also became ill on the same day, the Centers for Disease Control and Prevention reported on Friday.
“The disclosure raises the possibility that the virus, H5N1, spread from one person to another, experts said, in what would be the first known instance in the United States.
“On Friday night, C.D.C. officials said that there was “no epidemiological evidence at this time to support person-to-person transmission of H5N1,” but that additional research was needed.
“The coincidental timing of the illnesses, especially outside flu season, concerned independent experts. H5N1 has been known to spread between close contacts, including those living in the same household.
“And neither the initial patient nor the household contact had any known exposure to the virus via animals or raw milk.
“Neither patient has been identified, and details are scant. The household contact was not tested, so officials cannot be sure that the individual actually was infected with the bird flu virus.”
“U.S. obesity rates keep rising, with 1 in every 5 people in every state reported to be obese in 2023
“In 23 states, 35% or more of the population is now obese
“Tackling unhealthy weight gain as early as childhood may be key to turning these numbers around.”
The NIH Director cheers us up by writing in her blog,
In Parkinson’s disease, neurons in parts of the brain gradually weaken and die, leading people to experience worsening problems with movement and other symptoms. While the causes of this disease aren’t fully known, studies have suggested the Parkinson’s brain lacks fuel to power dopamine-producing neurons that are essential for movement. When too many of those neurons are lost, Parkinson’s disease symptoms appear. But what if there was a way to boost energy levels in the brain and stop the neurodegenerative process in its tracks?
While the findings are preliminary, an NIH-supported study reported in Science Advances takes an encouraging step toward this goal. The key element, according to the new work, is an energy-producing enzyme known as phosphoglycerate kinase (PGK1). In fact, these latest preclinical findings in models of the disease suggest that boosting this enzyme in the brain even slightly may be enough to restore energy and afford some protection against Parkinson’s disease.
The team, led by Timothy Ryan and Alexandros Kokotos, Weill Cornell Medicine, New York City, was inspired by recent discoveries suggesting an unexpectedly important role for PGK1 in protecting the normal function of neurons. They knew PGK1 plays an essential role in the pathway through which cells use glucose to generate and store energy in the form of adenosine 5′-triphosphate (ATP) molecules. The surprise came when studies showed the drug terazosin, which is used to treat high blood pressure and enlarged prostate, has an unexpected side effect: it enhances PGK1 activity, although perhaps weakly. * * *
“For the approximately one million Americans with Parkinson’s disease today, current treatments help to relieve symptoms but don’t stop the disease from progressing. These new findings raise the possibility that terazosin or drugs that enhance PGK1 activity even more may fuel the brain, helping to protect essential dopamine-producing neurons to treat or even prevent Parkinson’s disease, as well as other neurodegenerative conditions where PGK1 may play a role.”
“The National Institutes of Health (NIH) has established a pandemic preparedness research network to conduct research on high-priority pathogens most likely to threaten human health with the goal of developing effective vaccines and monoclonal antibodies. Currently, many of the diseases caused by these pathogens have no available vaccines or therapeutics, and investing in this research is key to preparing for potential public health crises—both in the United States and around the world. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) expects to commit approximately $100 million per year to fund the program, pending the availability of funds.
“The Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness network—called ReVAMPP—will focus its research efforts on “prototype pathogens,” representative pathogens from virus families known to infect humans, and high-priority pathogens that have the potential to cause deadly diseases. By studying specific prototype pathogens, scientists will build a knowledge base that could be applied to other related viruses. For example, NIAID’s earlier work on the Middle East respiratory syndrome coronavirus (MERS-CoV) played a crucial role in understanding and developing safe and effective treatments and vaccines for SARS-CoV-2, the virus that caused the COVID-19 pandemic. The ReVAMPP network will study viruses from virus families that have caused human disease for millennia—many of which have the potential to become pandemic threats in the future.
“In the wake of the COVID-19 pandemic and ongoing outbreaks of emerging infectious diseases, the need for robust pandemic preparedness is evident,” said NIAID Director Jeanne M. Marrazzo, M.D., M.P.H. “The ReVAMPP network will enable researchers to fill key knowledge gaps and identify strategies to develop safe and effective medical countermeasures for targeted virus families before the need becomes critical.”
“A new drug — approved by regulators last month — has shown it can delay tumor progression, meaning patients could get more years to work and travel and be with their families before subjecting themselves to the rigors of the more pernicious treatments, which can lead to a range of health and cognitive problems. It is one of the first major brain tumor breakthroughs in decades.
“It gives you more time to do the things you love to do and lets you live a more normal life,” said [a patient], who enrolled in the trial that led to the approval of the drug, called Voranigo and developed by the privately held French firm Servier.
“Taken as a daily pill, Voranigo, or vorasidenib, is a signal to researchers and other pharmaceutical companies that success in this field is possible. It’s also the first targeted therapy designed specifically for this brain cancer, homing in on a genetic mutation that drives tumor formation and bringing the type of the success seen in lung and breast cancers to among the most difficult-to-treat tumors.
“The drug, which has a list price of nearly $480,000 a year, is approved for patients with specific types of brain tumors — gliomas and astrocytomas — that are categorized as grade 2, a few thousand of which are diagnosed every year in the U.S. (Brain tumors are graded on a scale of 1 to 4, with higher grades indicating tumors that are more aggressive.) It’s also only meant for people who have particular mutations in one of two related genes, known as IDH1 or IDH2, who account for the large majority of low-grade glioma patients. Now, researchers are starting to test it in combination with other treatments in more advanced brain cancers.
“I was in the field for 38 years, and when you can count the number of approved drugs on one hand, you know you’ve got a difficult disease to treat,” said Mark Gilbert, who recently retired as chief of the National Cancer Institute’s neuro-oncology branch.”
Boar’s Head announced on Friday that it would indefinitely shut down the troubled Virginia deli meat plant that it acknowledged had caused a deadly listeria outbreak, killing nine people and sickening dozens more in 18 states.
The company also said it had identified liverwurst processing as the source of contamination and would permanently discontinue the product.
“Given the seriousness of the outbreak, and the fact that it originated at Jarratt, we have made the difficult decision to indefinitely close this location,” the company said in a statement posted on its website Friday. The shutdown affects about 500 workers in Jarratt, Va., a small rural town whose economic livelihood largely depended on the plant’s business.
“Employers are bracing for a third straight year with health benefit costs increasing more than 5%, according to a new report from Mercer.
“The organization released preliminary findings from its annual National Survey of Employer-Sponsored Health Plans and found that the total health benefit cost for individual employees is expected to increase by 5.8% in 2025. This accounts for any cost-reduction initiatives that employers may take on.
“The survey, based on responses from 1,800 employers across the country, estimates that with no cost-reduction efforts, expenses would increase by 7% per worker.”
“Elevance Health has entered into a deal to acquire Indiana University Health Plans, the company’s Anthem Blue Cross unit announced this week.
“Should the deal close, IU Health Plans will operate as part of Anthem in the Hoosier State, according to the press release. Financial terms of the sale were not disclosed.
“IU Health Plans provides Medicare Advantage plans to 19,000 people across 36 counties and has a 4.5-star rating from the Centers for Medicare & Medicaid Services. It also has 12,000 fully insured commercial plan members, according to the release.” * * *
“The parties expect the deal to close at the end of 2024.”
“Oakland, Calif.-based Kaiser Permanente received approval from the San Jose (Calif.) planning commission during a Sept. 11 meeting to move forward with plans to demolish its existing San Jose Medical Center and build a new hospital.
“Kaiser Permanente San Jose is excited about this new facility, which will provide greater access to high-quality care and medical services to our members and patients in the greater San Jose community,” a spokesperson for Kaiser shared with Becker’s in a Sept. 12 statement.
“The project, which the health system shared initial plans for in February, would demolish the current 250,000-square-foot hospital and develop a new 685,000-square-foot hospital, central utility plant and a five-level parking garage, resulting in the addition of around 800 new employees.
“It would also increase bed count from 247 to 303, according to project highlights during the meeting.”
“Steward Health Care exited a federal bankruptcy court hearing on Wednesday absolved of billions of dollars in outstanding lease agreements and with a plan to keep the majority of its remaining hospitals open.
“When Roche’s Genentech gained approval for Ocrevus in 2017, the first-in-class infused drug quickly became the best-selling treatment in a crowded multiple sclerosis (MS) market. Three years later, Novartis’ next-in-class Kesimpta stole some of Ocrevus’ thunder, offering a convenience edge with its once-monthly, at-home prefilled injection.
“Now, Genentech has responded with a new formulation as the FDA has endorsed a subcutaneous version of Ocrevus. While it can’t match the at-home convenience of Kesimpta, subcutaneous Ocrevus Zunovo, with its twice-a-year, under-the-skin dosing regimen, provides an attractive option.
“This is something than can be provided in clinics and doesn’t require people to go to an infusion center,” David Jones, Genentech’s medical director for MS, said in an interview. “This will expand access to individuals who may not be able to access Ocrevus now, especially for reasons like geography or rural setting, individuals that might have challenges with their healthcare provider.”
“Ocrevus Zunovo can be injected in 10 minutes, compared to the two-plus hours needed for an infusion of the drug. For patients who experience side effects, the intravenous infusion can take up to four hours.”
“It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company’s initial launch plans last year.
“The agency was originally slated to issue its verdict on Tecentriq in its under-the-skin formulation last September but the drug’s manufacturing processes needed updating, Roche’s delivery technology partner Halozyme Therapeutics said in a filing at the time. The tweaks, which a Roche spokesperson said were made in response to the FDA’s evolving requirements, were expected to wrap up in 2023 to support a 2024 launch. The world-first approval for the formulation came in the U.K. last year.
“Now, the therapy has been cleared for use in the U.S. in all of the Tecentriq adult formulation’s indications, including types of lung, liver, skin and soft tissue cancers. The new version uses Halozyme’s Enhanze drug delivery tech to subcutaneously inject the product over seven minutes, compared to the 30 to 60 minutes needed for an IV infusion.
“By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Roche’s chief medical officer and head of global product development Levi Garraway, M.D., Ph.D., said in a press release.”
“Two U.S. senators are aiming to crack down on deceptive or misleading online promotion of weight-loss and other prescription drugs by telehealth firms and social-media influencers who profit from their posts.
“New bipartisan legislation proposed by Sens. Dick Durbin (D., Ill.) and Mike Braun (R., Ind.) would authorize the Food and Drug Administration to warn and potentially impose costly fines on those who post false information online about medicines or omit important information about a drug’s safety risks.
“One impetus for the bill, according to a Senate aide, is the 2024 reporting by The Wall Street Journal about how social media has fueled demand for Ozempic and Wegovy from Novo Nordisk as well as other drugs used for weight loss. The Journal found that posts on platforms such as TikTok, YouTube and Instagram often omit information about difficult side effects, and that some influencers and companies profit from the posts.”
“Top executives at major pharmacy benefit managers are standing behind recent testimony on the Hill that put them in hot water with the chair of the powerful House Oversight Committee.
“Chair James Comer, R-Ky., accused Patrick Conway, the CEO of UnitedHealth’s Optum Rx; Adam Kautzner, the president of Cigna’s Express Scripts; and David Joyner, the president of CVS’ Caremark, of lying during a July hearing, and gave them until Wednesday to correct their statements or face potential fines or jail time.
“Optum Rx, Caremark and Express Scripts have responded to Comer and declined to change any testimony, the companies confirmed. The House Oversight Committee is “reviewing the PBMs’ written responses as well as the additional documents and information they provided,” according to a spokesperson.”
“Steward Health Care CEO Ralph de la Torre, M.D., defied a subpoena to testify before Congress Thursday morning, leading heads of the investigating committee to promise civil enforcement and criminal charges for the executive.
“During the summer, the Senate Committee on Health, Education, Labor and Pensions (HELP) had voted to issue its first subpoena in over 40 years. Chairman Bernie Sanders, D-Vermont, said at the time that de la Torre needed to “explain to Congress the financial chicanery that made him extremely wealthy while the hospitals he managed went bankrupt.”
“Sanders and Committee Ranking Member Bill Cassidy, M.D., R-Louisiana, said Thursday that de la Torre’s legal team suggested he would be in attendance until they received a letter eight days ago. The letter informed the committee that he would not be attending out of concern that his testimony could harm the company’s ongoing bankruptcy proceedings. His legal counsel also suggested that the senators planned to turn their hearing into a “pseudo-criminal proceeding.”
“The committee overruled the letter a day later and told de la Torre to show up anyway. He did not.”
“The Centers for Disease Control and Prevention Sept. 12 released a rural health strategic plan which includes the agency’s key priorities, objectives and outcomes in rural health for the next five years. The CDC’s priorities include advancing results-based engagement with partners and communities to address rural health challenges, strengthening rural health infrastructure and the workforce, advancing rural health science and improving rural health preparedness and response capacity. As part of the fiscal year 2023 Congressional appropriations, CDC created an Office of Rural Health to coordinate its growing rural health portfolio across the agency.”
“Today, the Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Health (OASH) and the Health Resources and Services Administration (HRSA), announce a Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984. * * *
“The proposed rule change, if finalized, would remove clinical research and institutional review board (IRB) requirements for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. The proposed rule, Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act, is based on rigorous analysis of clinical data.
“If the proposed rule is finalized, HHS expects this rule will allow a larger number of transplant centers to conduct HOPE Act kidney and liver transplants and will help reduce the stigma and health disparities associated with HIV.
“Today, the U.S. Department of Health and Human Services, through the Office of Research Integrity (ORI), finalized the 2024 Public Health Service (PHS) Policies on Research Misconduct. This rule updates the 2005 regulation and clarifies requirements for addressing research misconduct in PHS-funded research.” * * *
“The research landscape has changed over the past 20 years with new technology, scientific advances, and globalization, which increases the need for ORI to remain nimble and collaborative. ORI is committed to keeping up with the needs of the research community,” said ORI Director Sheila Garrity. “The Final Rule aims to adapt to our current time, support our colleagues in the research community, and fortify ORI’s role in fostering research integrity and preserving public trust in science for future generations.”
“Disease investigators have not been able to determine how a person in Missouri with no known exposures to animals or poultry became infected with an H5 bird flu virus, the principal deputy director of the Centers for Disease Control and Prevention said Thursday.
“But Nirav Shah said the ongoing investigation has turned up no evidence of onward spread of the virus, suggesting this case may turn out to be a one-off infection that defies explanation.
“Here’s the bottom line: Our influenza surveillance system is designed to find needles in haystacks,” Shah said at a news briefing. “Here in this case, we found such a needle, but we don’t know how it got there. Our investigation continues, and we will keep everyone updated as we learn more.”
“Gilead said Thursday that its twice-yearly antiviral reduced the risk of HIV infections by 96% compared to an expected rate of infection in a second pivotal trial, paving the way for the likely approval of the drug for pre-exposure prophylaxis, or PrEP.
“The study, which enrolled cisgender men, transgender women, transgender men, and gender nonbinary individuals who have sex with partners assigned male at birth, also showed that the antiviral, called lenacapavir, was 89% more effective than a daily pill called Truvada.
“Specifically, two out of the 2,180 participants taking lenacapavir contracted HIV, while nine out of the 1,087 individuals in the Truvada group did.
One dozen of 36 cinnamon products tested by a consumer group contained elevated levels of lead, according to a study released on Thursday that reinforced concerns about metals in foods after tainted cinnamon applesauce poisoned dozens of children last year.
The Consumer Reports team tested the spice and found high levels in lead in 12 items sold at discount stores and ethnic markets, with lead levels reaching 3.5 parts per million. New York, the only state with tough lead standards in spices, recalls spices — among them curry powder, chili powder, cumin and five-spice powder — with more than one part per million of lead. Consumer Reports advised that people throw out items with that amount.
The American Hospital Association News lets us know,
“The AHA Sept. 12 released a new report that found hospital and health system performance on key patient safety and quality measures was better in the first quarter of 2024 than it was prior to the COVID-19 pandemic, and that hospitals made these improvements while caring for patients with more significant health care needs.
“Hospitals and health systems are continuously working to advance patient safety and quality — which is always the hospital field’s top priority,” said AHA President and CEO Rick Pollack. “This report shows hospitals have made significant improvements on pre-pandemic performance in key patient safety outcomes. Hospitals’ commitment to improving patient outcomes and enhancing the patient experience continues to drive these efforts forward.”
“Among 95 patients who are overweight or obese, an experimental daily pill from Novo Nordisk reduced their mean body weight by 13.1%, NBC News reported Sept. 10.
“Novo Nordisk, the manufacturer of Ozempic, Wegovy, and other popular GLP-1 drugs, shared the phase 1 trial results at the European Association for the Study of Diabetes annual meeting.
“The Denmark-based company recruited 124 patients and randomly assigned them either a placebo or its daily pill candidate, amycretin, to take for 12 weeks. Amycretin is a GLP-1 and protein-based unimolecular amylin, according to an abstract on the association’s website.
“The trial’s primary endpoint was the number of treatment-emergent adverse events — which were found to be mild to moderate — and body weight changes were a key exploratory endpoint. The weight reduction results are “remarkable,” according to the abstract.
“The FDA warned that fezolinetant (Veozah), a hormone-free pill for moderate to severe hot flashes caused by menopause, could cause rare but serious liver injury.
“If women experience any signs or symptoms suggesting liver injury, they should stop fezolinetant, the agency said. Symptoms include new-onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.
“Treatment discontinuation may prevent worsening liver injury and may potentially return liver function to normal, the FDA explained.”
“National Institutes of Health (NIH) researchers and collaborators have found that being a carrier for sickle cell disease, known as having sickle cell trait, increases the risk of blood clots, a risk that is the same among diverse human populations that may not traditionally be associated with sickle cell disease. The study provides estimated clinical risks for people with sickle cell trait, which can inform clinical practice guidelines. Researchers examined the largest and most diverse set of people with sickle cell trait to date, which includes data from over 19,000 people of various ancestral backgrounds with sickle cell trait.
The study, published in Blood Advanceswas led by researchers at National Human Genome Research Institute (NHGRI), part of NIH, The Johns Hopkins University School of Medicine, Baltimore, and the company 23andMe, South San Francisco, California. * * *
“This study, therefore, provides important insights about patterns of venous blood clots and suggests a unique mechanism of blood clotting in people with sickle cell trait,” said Rakhi Naik, M.D., clinical director for the Division of Hematology at Johns Hopkins University, Baltimore, who co-led the study. “Knowing the risks of blood clots in people with sickle cell trait is important for situations such as surgeries or hospitalizations, which add to the risk of developing serious blood clots.”
Over 2 million people in the United States have sickle cell trait. People with sickle cell trait have one copy of the genomic variant that causes sickle cell disease, a genetic condition that causes red blood cells to become rigid and sticky, which blocks blood flow. While people with sickle cell trait typically do not have any associated health complications, they are carriers for sickle cell disease. In rare cases, sickle cell trait has been found to be a risk factor for health complications such as muscle breakdown, presence of blood in the urine and kidney disease.
“Nearly one in 20 adults in the U.S. are estimated to have atrial fibrillation, many more than previous studies had indicated, according to new data out of the University of California, San Francisco.
“Atrial fibrillation doubles the risk of mortality, is one of the most common causes of stroke, increases risks of heart failure, myocardial infarction, chronic kidney disease and dementia, and results in lower quality of life,” Jean Jacques Noubiap, MD, PhD, postdoctoral scholar at University of California, San Francisco, said in a press release. “Fortunately, atrial fibrillation is preventable, and early detection and appropriate treatment can substantially reduce its adverse outcomes.”
The Institute for Clinical and Economic Review announced the release of a Draft Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease. The Public comment period now open until October 8, 2024; Requests to make oral comment during public meeting also being accepted.
“Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.
Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.”
McKinsey and Company explain why the U.S. physician shortage isn’t going anywhere.
“A new [medical debt relief model] pioneered in North Carolina shows how hospitals could make money off of a larger national program.
“In North Carolina, hospitals are set to collect billions in federal money to cancel patients’ medical debt and implement new policies to help prevent debt from accumulating in the first place. The funding comes as part of the state’s Medicaid expansion.
“Hospitals have significant political power to work federal programs to their advantage, and the template opens the door to other creative ways to use taxpayer funds to pay providers for medical debt. Read the full case study here.”
“Anthem Blue Cross Blue Shield is requesting payments from some providers it alleges falsified patients’ medical records when prescribing Ozempic, Bloomberg reported Sept. 12.
“A spokesperson for Elevance Health, which owns Anthem BCBS, told Bloomberg it contacted a small number of providers about repayments for Ozempic prescribed to their patients. In some cases, the amount of repayment requested was more than $1 million.
“Representatives for Elevance told Bloomberg that Anthem BCBS only covers Ozempic for patients with Type 2 diabetes. The drug is not approved by the FDA for weight loss, but is often prescribed off-label for that purpose.”
“A Wilmington, Del.-based physician has agreed to pay more than $1 million to settle allegations he violated the False Claims Act by ordering medically unnecessary durable medical equipment for Medicare and Federal Employees Health Benefits Program patients.
“Vishal Patel, MD, referred patients for more than 1,750 orthotic devices between February 2018 and April 2019, according to a Sept. 11 Justice Department news release. The department alleged that Dr. Patel had no medical relationship with these patients and the referrals were based on brief reviews of their medical charts.
“Medicare and the Federal Employees Health Benefits Program paid more than $400 on average for each device, according to the release. The patient files were provided to Dr. Patel by RediDoc, a telemedicine company whose owners pleaded guilty in 2022 to their roles in a $64 million fraud scheme.
“The claims resolved by Dr. Patel’s settlement are only allegations and there has been no determination of liability, according to the release.”
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