Happy Veterans Day!

Medicare

Happy Veterans Day!

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

Thanks to all those who served our great country.

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

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

From Washington, DC

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

From the public health and medical research front

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

From the U.S. healthcare business front,

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

Friday Factoids

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Roundup

David Ermer–Medical / Rx research, Medicare, Obesity, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Healthcare Dive offers its perspective on the final Calendar Year 2025 Medicare payment rule issued last Friday.
  • Cardiovascular Business adds,
    • “The Centers for Medicare and Medicaid Services (CMS) has finalized a new payment policy that more than doubles the Medicare reimbursements hospitals receive for performing coronary computed tomography angiography (CCTA) exams. 
    • “Under its new 2025 Medicare Hospital Outpatient Prospective Payment System, CMS moved CCTA into a higher ambulatory payment classification (APC). CCTA revenue codes 75572, 75573 and 75574 all now fall under APC 5572.
    • “This update raised the CCTA payment rate from $175 all the way to $357.13.
    • “CCTA utilization is expected to skyrocket throughout the United States now that the payment rate has increased. One medical society is already celebrating the news.
    • “We’re thrilled with the CMS’s ruling, which better aligns with the cost of providing CCTA services,” Ahmad Slim, MD, chair of the Society of Cardiovascular Computed Tomography (SCCT) Health Policy and Practice Committee, said in a statement. “This is a huge win for U.S. providers as well as the entire cardiac imaging community, ultimately improving patient access to this essential diagnostic tool, which aligns with the society’s overall mission.”
  • STAT News points out,
    • “Medicare regulators on Friday finalized rules to pay for some mental health apps, a breakthrough for digital therapeutics companies that have struggled for a foothold in the health care system.
    • “The new rule creates codes that allow clinicians to bill Medicare for providing the apps and related services to their patients. Beginning January 1, 2025, the codes will enable payment for mental health apps authorized by the Food and Drug Administration under a specific regulation that includes just a handful of treatments for conditions like depression and substance use disorder. 
    • “The codes to cover the apps, which regulators call digital mental health treatment devices, were first proposed for the 2025 Centers for Medicare and Medicaid Services Physician Fee Schedule in July and were finalized with some minor changes after comments from industry and the public.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “AstraZeneca said its experimental weight loss pill was well tolerated by patients in an early-stage clinical trial.
    • “The Anglo-Swedish drugmaker’s closely watched weight loss pill, AZD5004, showed 5.8% weight loss after four weeks of treatment among patients with type 2 diabetes, it said Monday during the ObesityWeek conference in San Antonio, Texas.
    • “The trial of the once-daily drug—which mimics a gut hormone known as GLP-1 to control blood sugar and suppress appetite—showed no severe side effects among patients with dosages of up to 50mg.
    • “Investors are paying close attention to the safety and tolerability profile of experimental weight loss drugs. Roche Holding shares slumped 4.5% in early European trading in September after the company said its oral weight-loss drug candidate was generally well tolerated, but some patients showed gastrointestinal side effects.”
  • What’s more, BioPharma Dive tells us,
    • “New results from a small study of Viking Therapeutics’ oral obesity drug raised expectations among Wall Street analysts that the experimental tablet could prove superior among the growing ranks of would-be competitors to the popular weight loss treatments Wegovy and Zepbound.
    • “The updated data, presented over the weekend at a medical conference, showed treatment with the highest dose of Viking’s drug led to an average weight loss of about 8% after just four weeks. Adjusting for the placebo group’s results, the average change was nearly 7%, Viking said Monday.
    • “Viking had previously disclosed results for the first five doses tested in the study back in March. The new results come from three higher dose groups involving 27 people. Notably, the data showed the higher doses were not associated with meaningfully higher rates of gastrointestinal side effects like vomiting and nausea.”
  • Per Becker’s Hospital Review,
    • “Wegovy may significantly reduce hospital admissions for any cause and overall length of stay, according to a new analysis of data from Novo Nordisk’s phase 3 SELECT trial. 
    • “Compared to patients taking a placebo, those taking Wegovy (2.4 milligrams of semaglutide) were less likely to be hospitalized for any reason. Findings presented Nov. 3 during a session at the annual ObesityWeek conference showed admissions for any cause occurred in 33.4% of patients taking Wegovy, compared to nearly 37% in the placebo cohort. 
    • “The new findings are based on an analysis of data from Novo Nordisk’s multicenter, randomized Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity trial (SELECT), which began in 2018 and enrolled more than 17,000 adults in 41 countries.” 
  • The American Medical Association shares top tips that hematologists want their patients to know.
  • Consumer Reports, writing in the Washington Post, lets us know “How to pick a yogurt that tastes great and is good for you. Beyond traditional and Greek, there’s skyr and kefir, yogurts made with plant milks, and more.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Novant Health has completed its purchase of BlueCross BlueShield of South Carolina’s UCI Medical Affiliates, a company that manages and provides administrative services for urgent care centers and physical therapy facilities. 
    • “The acquisition includes 52 urgent care centers and 20 clinics across South Carolina that are part of UCI Medical subsidiaries Doctors Care and Progressive Physical Therapy, according to a news release. Financial details were not disclosed.”
  • Kaufmann Hall informs us about a recent 14-minute-long podcast,
    • “Following the COVID-19 pandemic, UMass Memorial Health in Worcester, Massachusetts began to pilot a new hospital-at-home program: one for postpartum patients. Benjamin Hamar, MD, Director of the Maternity Center at UMass Memorial and a member of the Maternal-Fetal Medicine Division, joins the podcast to tell host J. Carlisle Larsen more about the first-in-the-nation model.”
  • Per BioPharma Dive,
    • “Novo Nordisk is investing further in obesity and metabolic disease, signing a deal to use Ascendis Pharma’s delivery technology to advance a long-acting GLP-1 drug as well as develop products in diabetes and cardiovascular conditions, Ascendis said Monday.
    • “Per deal terms, Novo could pay up to $285 million in immediate and milestone-based fees to Ascendis for the GLP-1 drug, depending on its progress toward approval. In addition, Ascendis could receive up to $77.5 million for each additional drug developed.
    • “Ascendis has won Food and Drug Administration approval of two products using its extended-release technology, both in rare conditions. In partnering with Novo, Ascendis would gain entry into conditions that have blockbuster sales potential.”
  • The Hill reports,
    • “Supermarket chain Kroger has finalized a nearly $1.4 billion agreement to settle the majority of the claims made by states, counties and Native American tribes that accused the company of helping fuel the opioid epidemic. 
    • “Payments are expected to begin early next year. The amount includes up to $1.2 billion for state and local governments where it operates, $36 million to Native American tribes and about $177 million to cover lawyers’ fees and costs.”  * * *
    • “Kroger is one of the country’s largest grocery chains, operating stores in 35 states.  
    • “The finalization of this settlement, originally reached in September 2023, will deliver over $1.2 billion in support of opioid abatement efforts nationwide while resolving nearly all the outstanding opioid-related claims against the company,” a Kroger spokesperson said in a statement.  
    • “The company previously said the settlement is not an admission of wrongdoing or liability 
    • “In addition to the monetary payments, Kroger has agreed to injunctive relief that requires its pharmacies to monitor, report, and share data about suspicious activity related to opioid prescriptions.” 

Friday Factoids

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

From Washington, DC,

  • Lots of CMS announcements today.
    • Calendar Year (CY) 2025 Medicare Physician Fee Schedule Final Rule (Fact Sheet)
      • “By factors specified in law, average payment rates under the PFS will be reduced by 2.93% in CY 2025, compared to the average amount these services were paid for most of CY 2024. The change to the PFS conversion factor incorporates the 0% overall update required by statute, the expiration of the temporary 2.93% increase in payment for CY 2024 required by statute, and a relatively small estimated 0.02% adjustment necessary to account for changes in work relative value units (RVUs) for some services. This amounts to an estimated CY 2025 PFS conversion factor of $32.35, a decrease of $0.94 (or 2.83%) from the current CY 2024 conversion factor of $33.29.”
    • CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (Fact Sheet)
      • “In accordance with Medicare law, CMS is finalizing an update to OPPS payment rates of 2.9% for hospitals that meet applicable quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4% reduced by a 0.5 percentage point productivity adjustment.
      • “In the CY 2019 OPPS/ASC final rule with comment period, CMS finalized a proposal to apply the hospital market basket update to ASC payment system rates for an interim period of five years (CY 2019 through CY 2023). The CY 2024 OPPS/ASC final rule with comment period extended the interim period for an additional two years (through CY 2024 and CY 2025).
      • “Accordingly, using the hospital market basket update, CMS is finalizing an update factor to the ASC payment rates for CY 2025 of 2.9%. The update applies to ASCs meeting relevant quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4% reduced by a 0.5 percentage point productivity adjustment.”
    • Calendar Year 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (Fact Sheet)
      • “For CY 2025, CMS is increasing the ESRD PPS base rate to $273.82, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.7%. The CY 2025 ESRD PPS final rule also includes changes to the methodology for calculating the ESRD facility wage index, changes to the Low-Volume Payment Adjustment (LVPA) methodology, and several changes to the ESRD outlier policy.”
  • Per an October 30, 2024, CMS press release.
    • CMS updated the ‘Birthing-Friendly’ designation icons on Care Compare for the first time since rolling out the initiative in October 2023. Hospitals that attested to the Maternal Morbidity Structural measure in the Hospital Inpatient Quality Reporting Program received the designation. The icons will be refreshed using updated data from CY 2023. CMS created the designation to identify hospitals and health systems that participate in a statewide or national perinatal quality improvement collaborative program and that implement evidence-based care to improve maternal health. Eighty percent of pregnancy-related deaths are preventable, and Black, American Indian and Alaska Native, and Native Hawaiian and Pacific Islander people have the highest rates of pregnancy-related death. The ‘Birthing- Friendly’ designation is a step towards ensuring that all pregnant and post-partum people can find high-quality maternity care. 
  • Bloomberg adds,
    • The [Medicare physician fee schedule] rule quickly elicited calls for Congress to overhaul the way Medicare sets payment rates. Federal law requires that any payment increases be offset by equal cuts elsewhere in the program.
    • “To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” said a statement from Bruce A. Scott, president of the American Medical Association. 
    • “For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas,” Scott said.
  • and
    • “Overall Medicare payments to home health agencies will increase by 0.5%, or $85 million, next year under a final rule released Friday.
    • “The total amount reflects a 2025 payment increase of 2.7%, or $445 million, according to the rule (RIN 0938-AV28) from the Centers for Medicare & Medicaid Services. But that amount would be offset by an estimated 1.8% payment cut of $295 million as part of a “permanent behavior adjustment” based on the assumption that home health agencies altered their billing and coding activity to maximize reimbursements in previous years.
    • “The payment offsets are part of a CMS plan to use future rulemaking to recover billions of dollars in apparent overpayments.”
  • The American Hospital Association reminds us,
    • “Beginning Nov. 1 through Jan. 15, individuals and families can enroll in or change their health coverage options through the Health Insurance Marketplace. The Centers for Medicare & Medicaid Services expects that 97% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies. AHA’s #GetCovered page offers resources to help people choose the best coverage for themselves and their families.”  
       
  • Govexec reports that “Most TSP funds took a tumble in October. Only two portfolios in the federal government’s 401(k)-style retirement savings program ended last month in the black, ending a three-month run of gains.”
  • STAT News relates,
    • “The hospital industry has pushed back against Medicare payment reforms for years, arguing that the policies would financially hurt rural hospitals. 
    • “Two key senators on Friday released a plan to get around that issue by reinvesting some of the money saved from payment reforms to help rural and safety-net hospitals. Hospitals that keep providing services like trauma centers, labor and delivery units, and burn units would get financial bonuses, too. 
    • “The reforms, called “site-neutral” payments, would equalize Medicare payments for some services provided at hospital outpatient departments with what the program pays physician offices for the same services. The hospital industry at large has opposed the policy because it argues hospitals should get paid more because they have to provide round-the-clock care and have higher overhead costs. 
    • “Sen. Maggie Hassan (D-N.H.), who has led efforts on the issue, partnered on the policy proposals with Sen. Bill Cassidy (R-La.), who’s in line to lead the Senate’s health committee if Republicans take control of the chamber next year and sits on the committee that regulates Medicare payments. Hassan’s current GOP partner on a stalled site-neutral bill, Sen. Mike Braun (R-Ind.), is leaving the Senate at the end of this year.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • COVID-19 activity is declining in most areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southern and southeastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae have increased in the United States, especially in young children.
    • COVID-19
      • Nationally, COVID-19 activity has continued declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. National trends in growth of COVID-19 infections are uncertain overall. Decreases are predicted in some states, and slow growth is predicted from a low level in others.
      • The XEC variant is estimated to comprise 14-22% of circulating viruses as of October 26, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • Influenza
    • RSV
      • Nationally, RSV activity remains low. However, continuing signs of increased RSV activity have been detected in the southern and southeastern United States, particularly in young children. Emergency department visits and hospitalization rates are increasing in young children in some areas.
    • Vaccination
  • ABC News tells us,
    • “The total number of dengue fever cases in the U.S. is now more than double the number recorded all of last year, federal data shows.
    • “More than 6,800 cases of dengue have been reported nationally so far this year, according to data from the Centers for Disease Control and Prevention (CDC). Of those cases, more than 4,400 were locally acquired and more than 2,300 are travel associated.
    • “Locally acquired cases mean that those infected have no history of traveling to an area where dengue normally spreads, including tropical and subtropical areas of the world.
    • “The 6,800 figure is more than double the 3,352 dengue cases reported during all of 2023, CDC data shows.
    • “Currently, Puerto Rico makes up the bulk of cases this year with more than 4,200 reported there, according to CDC data. Earlier this year, the territory declared a public health emergency amid a rise in dengue case.”
  • The American Journal of Managed Care lets us know,
    • “Early smoking cessation post-cancer diagnosis significantly improves survival, with optimal benefits seen when quitting within 6 months.
    • “The Tobacco Research and Treatment Program at MD Anderson offers free, evidence-based cessation interventions, including counseling and pharmacotherapies.
    • “The study highlights a reduced mortality risk for patients who quit smoking by 3-, 6-, and 9-months post-treatment.
    • ‘Limitations include potential bias from self-reported abstinence and lack of data on noncancer health conditions.”
  • The University of Minnesota’s CIDRAP informs us,
    • “A multistate study of publicly insured children diagnosed as having pneumonia found that one in five did not receive antibiotics, researchers reported yesterday in JAMA Network Open.
    • “But while children who didn’t receive antibiotics had slightly higher rates of treatment failure than those who did, severe outcomes were rare regardless of antibiotic treatment, the researchers found.
    • “The study authors say their findings suggest future research should aim to identify children with pneumonia who can be safely managed without antibiotics.” 
  • STAT News reports,
    • “Novo Nordisk’s weight loss drug Wegovy helped people with a fatty liver disease called MASH experience improvements in liver scarring and achieve symptom resolution, results the company sees as supporting regulatory approval.
    • “After 72 weeks in a Phase 3 trial, 37% of patients on Wegovy experienced an improvement in liver scarring, or fibrosis, with no worsening of their disease. That compared with 23% of those on placebo, according to topline results Novo announced Friday.
    • “Additionally, 63% of people on Wegovy achieved resolution of their symptoms with no worsening of fibrosis, compared with 34% of participants on placebo.
    • “Novo said the results were statistically significant.
    • “GLP-1 drugs like Wegovy are increasingly being tested in a range of conditions beyond obesity, including diseases that affect the heart, kidneys, and liver. Wegovy is already approved to prevent cardiovascular complications, and for Novo, proving that the drug helps with even more complications may help it gain broader and more streamlined insurance coverage.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Tenet Healthcare posted $5.1 billion in revenue for the third quarter, exceeding analysts’ expectations as the provider’s hospital and ambulatory segments fielded higher-than-expected patient volumes.
    • “Business in Tenet’s ambulatory care service line was particularly strong, executives said during a Tuesday morning call with investors. Adjusted earnings before interest, taxes, depreciation and amortization for Tenet’s ambulatory surgery centers and surgical hospitals sat nearly 19% higher than this time last year at $439 million.
    • “Still, the company lowered the upper end of its 2024 revenue guidance to $20.6 billion to $20.8 billion, compared to prior guidance of $20.6 billion to $21 billion. Analysts from Leerink Partners said the revision was likely due to the performance of Tenet’s hospital portfolio and the timing of several hospital divestitures.”
  • Beckers Hospital Review points out,
    • “The University of Alabama at Birmingham Health System Authority has acquired Ascension St. Vincent’s Health System, effective Nov. 1. 
    • “Under the agreement, UAB Health System assumed ownership of all Ascension St. Vincent’s care sites, including the hospitals at Birmingham, Blount, Chilton, East and St. Clair, as well as the Trussville Freestanding Emergency Department, imaging centers and other clinics that are part of Ascension Medical Group. 
    • “The transaction was valued at $450 million.” 
  • Kaufmann Hall offers an infographic “reassessing retail health disruptors” one year later.

Happy Halloween

David Ermer–CMS, COVID-19, Electronic health records, FDA, Medical / Rx research, Medicare, NIH, Obesity, Telehealth, U.S. Healthcare–
Photo by Toa Heftiba on Unsplash

From Washington, DC,

  • Tammy Flanagan, writing in Govexec, answers Federal Benefits Open Season questions from readers.
  • Bloomberg reports,
    • “The [U.S. Court of Appeals for the] Third Circuit [sitting in Philadelphia] Wednesday wrestled with the constitutionality of a government drug price negotiation plan, hearing arguments from three drugmakers and the Biden administration over alleged industry harm and violations of property and speech. 
    • “Drugmakers Johnson & Johnson, Bristol-Myers Squibb Co., and AstraZeneca PLC took their challenge against the US government’s Medicare Drug Price Negotiation Program to the US Court of Appeals for the Third Circuit. The plan, created under President Joe Biden’s landmark Inflation Reduction Act, is part of the administration’s efforts to rein in high prescription drug costs by allowing the government to negotiate prices for certain drugs with manufacturers.” 
    • This is the first federal appellate court oral argument on this issue.

From the public health and medical research front,

  • Dr. Monica Bertagnollo, the NIH Director, writes in her blog,
    • “In 2021, NIH launched the Researching COVID to Enhance Recovery (RECOVER) Initiative , a nationwide research program, to fully understand, diagnose, and treat Long COVID. We continue to learn more about this condition, in which some people experience a variety of symptoms for weeks, months, or even years after infection with SARS-CoV-2, the virus that causes COVID-19. But we’re still working to understand the underlying reasons why people develop Long COVID, who is most likely to get it, and how best to treat or prevent it.
    • “Studies have shown that for some people, SARS-CoV-2 doesn’t completely clear out after acute infection. Scientists have observed signs that the virus may persist in various parts of the body, and many suspect that this lingering virus, or remnants consisting of SARS-CoV-2 protein, may be causing Long COVID symptoms in some individuals. Now, in a new study supported by RECOVER, scientists found that people with Long COVID were twice as likely to have these viral remnants in their blood as people with no lingering symptoms. The findings, reported in Clinical Microbiology and Infection, add to evidence that Long COVID may sometimes stem from persistent infection or SARS-CoV-2 protein remnants.” * * *
    • “More study is needed to understand the causes of Long COVID symptoms in people who test negative for persistent infection, the researchers note. They are conducting follow-up studies in even more people with Long COVID, including those with compromised immune systems. They hope to learn more about what causes some people to be at higher risk for retaining some SARS-CoV-2 protein remnants and Long COVID.”
  • Per an NIH press release,
    • “Young people with severe obesity who underwent weight-loss surgery at age 19 or younger continued to see sustained weight loss and resolution of common obesity-related comorbidities 10 years later, according to results from a large clinical study funded by the National Institutes of Health (NIH).
    • “Study participants with an average age of 17 underwent gastric bypass or sleeve gastrectomy weight-loss surgery. After 10 years, participants sustained an average of 20% reduction in body mass index (BMI), 55% reduction of type 2 diabetes, 57% reduction of hypertension, and 54% reduction of abnormal cholesterol. Both gastric bypass and sleeve gastrectomy had similar results.
    • “The 55% reduction in type 2 diabetes was much higher than the rates observed in adults after weight-loss surgery (18% at seven years and 12.7% at 12 years) in a recently published NIH-funded study.
    • “Type 2 diabetes tends to progress more rapidly when it occurs in young people, and these findings demonstrate the greater health benefits and durability of bariatric surgery in youth than would be expected in similarly treated adults.”
  • JAMA Open Network tells us,
    • Question  How have autism diagnosis rates changed over time among children and adults seeking care from a network of health systems in the US?
    • Findings  In this cross-sectional study of electronic US health and insurance claims records for over 9 million individuals per year from 2011 to 2022, relative increases in autism diagnosis rates were greatest among young adults compared with all other age groups, female compared with male individuals, and some racial and ethnic minority groups compared with White individuals among children but not adults.
    • Meaning  Patterns of increase in autism diagnosis rates reflect a need for expanded health care services and continued research on sociodemographic disparities among this growing population.
  • The Institute for Clinical and Economic Review published an Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
    • Current evidence suggests that tabelecleucel provides a substantial net health benefit when compared to usual care; treatment would achieve common thresholds for cost-effectiveness if priced between $143,900 to $273,700 per treatment cycle. * * *
    • “EBV+ PTLD is a rare and often fatal cancer associated with solid organ transplant and stem cell transplant,” said ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “Unfortunately, approximately half of EBV+ PTLD cases are refractory to initial treatment or relapse, resulting in a poor prognosis. The limited evidence on tabelecleucel suggests that it provides important clinical benefits in patients with relapsed refractory EBV+ PTLD, extending survival for patients who otherwise do not usually survive beyond a few weeks to months, with few harms.” 
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on November 14, 2024. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • STAT News informs us,
    • After spending decades fixated on a single hypothesis, Alzheimer’s researchers are increasingly searching for new ways to combat the devastating neurologic disease. One such approach — precisely targeting the brain with magnetic pulses — got a boost when mid-stage trial data was presented Thursday.
    • Scientists reported that patients with mild or moderate Alzheimer’s who received the therapy, known as transcranial magnetic stimulation (TMS), experienced a 44% slowing in their rate of disease progression after a year compared to those given a sham intervention, which mimicked the procedure but delivered no treatment. That finding, which was the study’s main endpoint and was statistically significant, was based on a commonly used disease metric known as Clinical Dementia Rating sum of boxes (CDR-SB).” * * *
    • “But outside experts were quick to caution that the new results, announced at the Clinical Trials on Alzheimer’s Disease conference in Madrid, should be taken with a grain of salt. That’s because the findings come from a small Phase 2 trial conducted at a single medical center in Italy, with 32 patients completing the trial. Sinaptica, a private biotech in Cambridge, Mass. that is developing the treatment and sponsored the trial, is now planning a larger, multicenter pivotal study in hopes of confirming its findings.”

From the U.S. healthcare business front,

  • The American Hospital News lets us know,
    • “Baxter announced Oct. 31 that it has restarted its North Cove, N.C. facility’s highest-throughput IV solutions manufacturing line, which normally accounts for nearly 25% of the site’s total production and approximately 50% of its one-liter IV solutions — the most commonly used size by hospitals and clinics. The earliest new products could begin shipment is late November, Baxter said. The company is continuing to assess and repair equipment at the facility and is working with the Food and Drug Administration to resume operation in phases. Baxter said it does not have a timeline on when production at the facility will be restored to pre-Hurricane Helene levels.” 
  • Healthcare Dive relates,
    • “Cigna CEO David Cordani threw cold water on speculation that the health insurer is interested in acquiring rival Humana during a call with investors on Thursday.
    • “Despite reports earlier this fall that the two payers had reopened deal talks, Cigna plans to use excess cash to buy back shares, Cordani said while discussing Cigna’s third quarter results.
    • “Cigna handily beat Wall Street expectations in the quarter with revenue of $63.7 billion, up 30% year over year after strong demand for specialty drugs spurred growth in its health services division. However, an investment loss of $1 billion tied to the waning value of primary care chain VillageMD drove Cigna’s profit down to $739 million, compared to $1.4 billion same time last year.”
  • Risk & Insurance points out,
    • “Employers that implement strategies like value-based drug formularies and tiered provider networks are experiencing lower health care costs, according to a survey by the National Alliance of Healthcare Purchaser Coalitions.
    • “The survey, which included responses from 188 employers, sheds light on the ongoing challenge of rising health care costs and the various approaches being taken to address this issue, which has significant implications for both businesses and employees.”
  • Modern Healthcare informs us,
    • “Steward Health Care completed the $245 million sale of its physician group, Stewardship Health, to private equity-owned Rural Healthcare Group.
    • “As part of the transaction, Kinderhook Industries, the private equity firm that owns Rural Healthcare Group, plans to rebrand the combined company as Revere Medical, Kinderhook said Thursday in a news release. The acquisition adds about 5,000 employed and affiliated Stewardship physicians across nine states to Revere’s network of 17 primary care clinics in Tennessee and North Carolina.
    • “Revere plans to invest in Stewardship infrastructure and technology and has pledged to allow patients to stay with their doctors, according to the release.
    • “The Stewardship team is excited for this next chapter with Revere Medical as it provides a committed partner focused on quality care and improving the clinic experience for providers, clinic teams, and patients,” Dr. Joseph Weinstein, president of Stewardship, said in the release.
    • “The Stewardship sale is one of the last remaining transactions in Steward’s Chapter 11 bankruptcy restructuring.”
  • Per Fierce Healthcare,
    • “Optum Rx is rolling out a slate of new programs that seek to support independent pharmacies in managing costs and more complex patient needs.
    • “The first offering under this initiative is Optum’s new Independent Pharmacy Network, which is available as an add-on for its pharmacy benefit management clients. In contracts that select this option, independent and community pharmacies will receive 5% higher reimbursements for generics and 0.2% higher for branded drugs.
    • “The PBM said this program follows other changes enacted to support independent pharmacies; for instance, it does not collect direct and indirect remuneration, or DIR, fees and removed clawbacks for independent facilities.”
  • and
    • “Teladoc Health had a better quarter than Wall Street expected, posting $640.5 million in revenue and losing less per share than expected, at $0.19. Quarterly revenue decreased by 3% from 2023 and was down slightly from Q2’s $642.4 million.
    • “In the Q3 earnings call, Teladoc executives stressed the stability of the U.S. virtual care segment, which has gained millions of users since last year. It called BetterHelp a “company in transition,” as the company pivots hard to offset the cost of a $790 million impairment charge in the second quarter.
    • “BetterHelp, Teladoc’s virtual mental health solution, continue to drag down its performance as the segment’s revenue fell 10% year-over-year, coming in at $256.8 million in Q3.”
  • Per Fierce Pharma,
    • “Bristol Myers’ $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company’s ongoing efficiency push. 
    • “BMS management is “reviewing overall spending and prioritizing investments that will deliver the best long-term returns,” CEO Chris Boerner, Ph.D., said during a call Thursday. The New Jersey-based pharma is on track to deliver on its existing $1.5 billion cost-saving target by the end of next year, the CEO confirmed.
    • “We see the drive for greater operational excellence as a continuous process,” Boerner continued. “As such, we are exploring opportunities to further improve productivity and efficiency over the coming quarters.”
    • “Later during the call, CFO David Elkins said BMS is “continuing to look for efficiencies in our cost base, and you’ll continue to hear more about that.”
  • Per BioPharma Dive,
    • “Sales of GSK’s top-selling vaccines fell sharply during the third quarter amid lower demand, sending shares in the British pharmaceutical company down 3% in U.S. trading Wednesday.
    • “GSK, which had downgraded its vaccine sales forecasts in July, did so again Wednesday in reporting earnings for the third quarter. The company now expects vaccine sales to decline by low single digits versus last year.
    • “During the third quarter, sales of GSK’s shingles vaccine dropped by 7% compared to the same period in 2023, while sales of its shot for respiratory syncytial virus, Arexvy, plunged by 72% year over year.
    • “In a presentation, GSK attributed the drop of Arexvy to several factors, including a narrower recommendation from the Centers for Disease Control and Prevention, prioritization of COVID vaccinations in the U.S. and lower rates of RSV infections this season.
    • “The decline mirrored that of Pfizer’s competing vaccine Abrysvo, sales of which came in lower this quarter compared to last year’s. Pfizer also cited the CDC recommendation, which focuses on vaccination for adults 75 years or older, as well as those between 60 and 74 years who are at higher risk of disease. Previously, the CDC had urged all adults 60 and older — for whom both Arexvy and Abrysvo are approved — to discuss vaccination with their doctor.”
  • Per Healthcare Dive,
    • “Oracle will launch a new artificial intelligence-backed electronic health record next year, the technology giant said Tuesday.
    • “The EHR will allow clinicians to use voice for navigation and search. It will also integrate the company’s clinical AI agent and tools for data analysis and tracking patient flow through the hospital.
    • “The new record marks a major health initiative for Oracle, which acquired EHR vendor Cerner for more than $28 billion in 2022. “This isn’t a refurbished Cerner EHR,” Seema Verma, executive vice president and general manager of Oracle Health and Life Sciences, said during the Oracle Health Summit on Tuesday. “Because in this day and age, you can’t leverage modern technology by bolting new innovation to something built in the 1990s.”

Monday Roundup

David Ermer–CMS, Congress, FDA, Federal employment benefits, HSA, Medical / Rx research, Medicare, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec offers a commentary on why federal and postal employees should consider a high deductible plan with a health savings account in the upcoming Open Season.
    • The FEHBP misses his CareFirst HDHP/HSA when Medicare became his primary health insurer at the end of 2019. The FEHBlog likes Medicare. He wonders whether the November 5 election is causing CMS to delay announcing Medicare premiums and cost sharing for 2025. Congress should pass a law requiring CMS to release this information before the beginning of the annual Medicare Open Enrollment on October 15.
  • Beckers Hospital Review lets us know,
    • Baxter has received FDA approval to extend the shelf life of more than 50 intravenous and irrigation products by up to 12 months, now allowing for a 24-month expiry from products made before September 2024, according to an Oct. 28 news release from the company. 
    • Here are four other IV shortage updates: 
      • A completed temporary bridge has already moved more than 825 truckloads of finished products from Baxter’s North Cove, N.C. facility. A second bridge is set to open in early November. 
      • Baxter anticipates restarting its primary IV solutions line the week of Oct. 28, aiming to begin distribution of new products by mid- to late November, the release said. 
      • Nine Baxter plants are supplementing North Cove’s output to stabilize supply levels in the U.S. 
      • Conservation efforts for IV and peritoneal dialysis solutions remain crucial, with Baxter’s supporting healthcare systems on product management strategies, according to the release. 
  • Federal News Network tells us,
    • “Agencies with higher employee satisfaction scores are also getting top marks on their performance.
    • “Research from the Partnership for Public Service finds agencies that received the highest internal customer experience scores also ranked high on the Federal Employee Viewpoint Survey.
    • “Brandon Lardy, the Partnership’s senior manager for data science and Strategy, said the study is part of its ongoing work to produce customer experience metrics on par with FEVS data or its Best Places to Work in the Federal Government ranking.”
  • The Wall Street Journal reports,
    • “The Biden administration took steps to alleviate shortages of cancer drugs for children, part of a final push for one of the president’s domestic priorities: reducing the nation’s cancer burden.
    • “The federal government is testing a new way to prevent treatment disruptions for seven pediatric cancer drugs by improving communication between hospitals, nonprofits and wholesalers. Shortages of cancer medicines regularly plague hospitals and patients, sometimes forcing them to delay or change care. 
    • “No one in this country should struggle for access to the treatment they need, but kids and families facing cancer in particular,” said Danielle Carnival, an adviser to Biden who leads his “Cancer Moonshot” effort.” 

From the public health and medical research front,

  • STAT News reports,
    • “If one can point to anything good about the H5N1 bird flu outbreak in dairy cattle — to be honest, there’s nothing good about this situation — it’s the timing. Transmission of the virus through U.S. dairy herds took off when last winter’s flu season was effectively over, making the job of looking for people infected with H5N1 an easier task in theory, though there have been plenty of human hurdles impeding those efforts.
    • “But in the months since the outbreak was first detected, the spread of the virus in cows has not been contained, with infections reported in 380 herds in 14 states so far. Now, with cold and flu season looming, it is likely to become significantly more difficult for the country’s public health departments to track the virus. 
    • “If one can point to anything good about the H5N1 bird flu outbreak in dairy cattle — to be honest, there’s nothing good about this situation — it’s the timing. Transmission of the virus through U.S. dairy herds took off when last winter’s flu season was effectively over, making the job of looking for people infected with H5N1 an easier task in theory, though there have been plenty of human hurdles impeding those efforts.
    • “But in the months since the outbreak was first detected, the spread of the virus in cows has not been contained, with infections reported in 380 herds in 14 states so far. Now, with cold and flu season looming, it is likely to become significantly more difficult for the country’s public health departments to track the virus.”
  • Beckers Hospital Review names the ten most health and the ten least health cities in our country.
    • “Detroit leads the list of cities with the least healthy populations, while San Jose, Calif., has the healthiest residents, according to a new ranking published Oct. 28 by Forbes Advisor, a financial services and personal finance website affiliated with Forbes.
    • “In making its determination, Forbes Advisor compared the 46 most populated U.S. cities with available data across eight metrics. Metrics ranged from the number of heart disease deaths per 100,000 residents to the percentage of adults who report physical inactivity.
    • “Data for the analysis comes from the City Health Dashboard and the Census Bureau. Read more about the methodology here.”
    • Austin, Texas, where the FEHBlog lives, is listed as the city with the second healthiest population, following San Jose, California.
  • Consumer Reports, writing in the Washington Post, discuss “seven winning dietary supplements for sleep, bone health and more. As for which brands, the key is choosing products that have been verified to be free of contaminants and to contain what their labels claim.”
  • Per National Institutes of Health press releases,
    • “A study from researchers at National Institutes of Health (NIH) and their collaborators revealed a significant genetic risk factor for kidney disease in people from Ghana and Nigeria. Their study demonstrated that having just one risk variant in a gene known as APOL1 can significantly increase the risk of developing kidney disease. APOL1 is important for the immune system and variants of the gene are linked to increased risk of chronic kidney disease. The study is published in the New England Journal of Medicine and was conducted by researchers from the Human Heredity and Health in Africa (H3Africa) Kidney Disease Research Network.
    • “Previous research established that genomic variants in APOL1 increase the risk of developing chronic kidney disease among African Americans. However, not much is known about how these genomic variants affect people from West African countries, where many African Americans derive genetic ancestry. Studying how these genomic variants contribute to chronic kidney disease in West Africans and people with West African ancestry can also help inform the risk of kidney disease in many Americans.”
  • and
    • “A highly pathogenic avian influenza (HPAI) H5N1 virus, isolated from the eye of a farm worker who became infected through contact with dairy cows, was lethal in mice and ferrets infected in a high-containment laboratory environment, according to a new study in Nature. The study investigators also found that the virus isolated from the worker, who experienced mild inflammation of the cornea (conjunctivitis), could be transmitted through the air between separated ferrets and might be capable of binding to and replicating in human respiratory tract cells.
    • “The virus isolated from the worker is called huTX37-H5N1 and has a mutation (PB2-E627K) frequently seen in avian influenza viruses that replicate in mammals, typically making virus replication more efficient. These mutations underscore the need for continued monitoring and evaluation of viruses from the current H5N1 outbreak.
    • “The study also showed that a bovine H5N1 virus is susceptible to the antiviral drugs favipiravir and baloxavir marboxil (brand name Xofluza) of the polymerase inhibitor class, as well as the neuraminidase inhibitor zanamivir. The virus is less sensitive to oseltamivir (Tamiflu), another neuraminidase inhibitor.” * * *
    • “In summary, this study characterizes the huTX37-H5N1 isolate, finding that it may be capable of replicating in cells of the respiratory tract in humans, that it is pathogenic in mice and ferrets, and that it is capable of being transmitted by the respiratory route in ferrets. The authors note that “based in these observations, every effort should be made to contain HPAI H5N1 outbreaks in dairy cattle to limit the possibility of further human infections.”
  • From the U.S. healthcare business front,
  • AHIP shows us where our healthcare dollar goes.
  • For experience rated FEHB plans, which serve the vast majority of subscribers, the profit is less than one cent of each dollar. Other FEHB plans can enjoy the 2.4 cents profit.
  • Beckers Hospital Review points out “50 things to know about hospital consolidation and what consolidation means for the future of healthcare.
  • Per Fierce Healthcare
    • “Leaders at UnitedHealth Group and Amedisys are set to meet with the Department of Justice this week in hopes of avoiding a potential attempt to block their $3.3 billion merger deal, according to media reports.
    • “Bloomberg reported that the “last rites” meeting is generally the last step before regulators decide to intervene in a deal or not. It’s possible that the antitrust enforcers will allow the two companies to move forward with the deal with some changes that address competition concerns, according to the article.
    • “People familiar with the matter told Bloomberg there has been no definitive decision to challenge the deal. The DOJ will need to make a choice by the end of the month, based on an arrangement with UHG and Amedisys, according to the article.”
  • and
    • “Elevance Health plans to acquire home health company CareBridge in a deal that’s reportedly worth $2.7 billion.
    • “Elevance CEO Gail Boudreaux told investors on the company’s earnings call earlier this month that the company’s Carelon division “recently” entered into a deal to acquire CareBridge. 
    • “Further details on the transaction have not yet been disclosed. The Nashville Business Journal, where CareBridge is based, reported that Elevance Health would pay $2.7 billion for the home health company. The article called CareBridge the “fastest growing” company in the Tennessee city.
    • “On the call, Boudreaux said that CareBridge will “serve as the foundation for Carelon’s home health business, and we’re excited to continue to serve all its customers and members.” CareBridge provides value-based care in the home and community for people with complex and chronic conditions.”
  • and
    • “Universal Health Services (UHS) beat analysts’ estimates for third-quarter revenue as its top line grew 11% from 3.963 billion to reach $3.96 billion thanks to solid growth by its acute care hospitals and behavioral health care services.
    • “A year ago, UHS brought in $3.56 billion in revenue in the third quarter of 2023.
    • “The King of Prussia, Pennsylvania-based for-profit health system reported that adjusted admissions rose 1.5% from a year ago. Meanwhile, the total number of days patients stayed increased by 2% as compared to the same period in 2023.” * *
    • “The company also saw net revenue per adjusted admission rise by 7% while net revenue per adjusted patient day increased by 6.5% as compared to the third quarter of 2023. Net revenue from hospital services rose by 9.2% during the third quarter of 2024.
    • “UHS has approximately 96,700 employees and, through its subsidiaries, operates 27 inpatient acute care hospitals and 333 inpatient behavioral health facilities as well 40-plus outpatient facilities and ambulatory care access points. UHS also has an insurance offering and a physician network.”
  • Per Healthcare Dive,
    • “Providence is expanding its presence in the home care market after the nonprofit health system agreed to launch a joint venture this week with home care provider Compassus.
    • “The JV, which will be called Providence at Home with Compassus, will offer home health, hospice, community-based palliative care and private duty caregiving services. 
    • “Compassus will manage operations, according to a press release. The JV will operate 24 home health locations in Alaska, California, Oregon and Washington, and 17 hospice and palliative care locations in Alaska, California, Oregon, Texas and Washington. There’s no timeline yet on when the parties might finalize the proposed JV, and the deal is still pending regulatory review in Oregon.”
  • The Wall Street Journal reports,
    • “AbbVie has agreed to buy Aliada Therapeutics, a biotechnology company backed by Johnson & Johnson, for $1.4 billion in cash in a deal that adds a potential therapy for Alzheimer’s disease to AbbVie’s neuroscience pipeline.
    • “AbbVie on Monday said Aliada’s lead investigational asset, ALIA-1758, is an anti-pyroglutamate amyloid beta antibody that uses a novel blood-brain barrier-crossing technology and is in development for the treatment of the memory-robbing disease.” * * *
    • “The deal is slated to close by the end of the year.”

Weekend Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Congress remains on the campaign trail until the lame duck session begins November 12.
  • On October 7, the Supreme Court invited the Solicitor General to file a brief in a Tenth Circuit ERISA preemption case, Mulready v. PCMA, No. 23-1213, expressing the views of the United States. The case bears on FEHB preemption of state PBM laws regulating PBM contracts with FEHB carriers. Because the national election will result in a new President on January 20, 2024, it’s likely that the Solicitor General will not submit a brief in this case until next Spring.
  • Beckers Payer Issues offers a useful perspective on HHS OIG and other investigative reports alleging that Medicare Advantage plans game the Medicare program by arranging for plan nurses to visit plan members to conduct health risk assessments.
    • “In a statement published Oct. 24, Mary Beth Donahue, president and CEO of the Better Medicare Alliance, said the report “paints a misleading picture of in-home health assessments.” 
    • “The Better Medicare Alliance is backed by major insurers. 
    • “Medicare Advantage is designed to achieve a better overall understanding of individuals’ health, and in-home assessments are a crucial part of this model,” Ms. Donahue said. “This information ensures seniors get the resources they need. We have supported codified best practices for these assessments and will continue to do so.” 
    • “In an Oct. 24 statement, AHIP, the trade association representing insurers, said CMS did not concur with key recommendations in the OIG’s report. 
    • “The agency did not concur with recommendations from the OIG to restrict payments for diagnoses found during in-home visits. 
    • “In its statement, AHIP said that health risk assessments are “one of many tools” MA plans use to identify chronic conditions and prevent these conditions from becoming more serious. 
    • “Whether they occur in the patient’s home or in a clinical office setting, the HRA offers an opportunity for the health plan and provider to obtain a complete evaluation of the patient’s physical, behavioral, and mental health needs, medications, health risks, and environmental factors that affect health,” the association said.” 
  • Cardiovascular Business tells us,
    • “Medtronic has received U.S. Food and Drug Administration (FDA) approval for its new Affera mapping and ablation system with the Sphere-9 catheter, an all-in-one electrophysiology offering capable of pulsed field ablation (PFA) and radiofrequency (RF) ablation. The system was approved to treat persistent atrial fibrillation (AFib) and cavotricuspid isthmus-dependent atrial flutter. It previously received CE mark approval in March 2023.
    • “Medtronic is now the first company to offer two FDA-approved PFA systems for the treatment of AFib. The company’s PulseSelect PFA system gained FDA approval in December 2023. 
    • “The Sphere-9 catheter at the heart of this system includes a 9 mm lattice tip designed to deliver wide-area circumferential ablations. It can provide either pulsed field or RF energy, a feature that puts more treatment options at the fingertips of operators than other commercially available PFA offerings. 
    • “The significance of this innovative technology should be underscored; Affera is a game changer for treatment of AFib and atrial flutter,” Vivek Reddy, MD, director of cardiac arrhythmia services for the Mount Sinai Health System in New York City and a known leader in ablation technologies, said in a statement. “The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of AFib.”

From the public health and medical research front,

  • The AP reports,
    • “McDonald’s announced Sunday that Quarter Pounders will again be on its menu at hundreds of its restaurants after testing ruled out beef patties as the source of the outbreak of E. coli poisoning tied to the popular burgers that killed one person and sickened at least 75 others across 13 states.
    • “The U.S. Food and Drug Administration continues to believe that slivered onions from a single supplier are the likely source of contamination, McDonald’s said in a statement. It said it will resume selling the Quarter Pounder at affected restaurants —- without slivered onions — in the coming week.
    • “As of Friday, the outbreak had expanded to at least 75 people sick in 13 states, federal health officials said. A total of 22 people had been hospitalized, and two developed a dangerous kidney disease complication, the Centers for Disease Control and Prevention said. One person has died in Colorado.”
  • Fortune Well identifies 17 factors that may play a role in whether a person suffers a stroke.
    • Stroke rates are rising, with over half a million Americans having a first stroke every year. But up to 80% of strokes may be preventable, which is why it’s so important to understand and mitigate your risk factors.
    • That’s according to the American Stroke Association, which this week released its first new clinical guidelines for strokes in a decade. 
  • Fortune Well also shares four lessons about “leadership, parenting, and setbacks” that the UPS Stores president learned from suffering a severe heart attack at age 47.
    • “Sarah Casalan remembers several clear details from the night of her heart attack two years ago: First, she kept thinking she had indigestion from the hamburger she’d made herself for dinner the night before, though it was unusual, considering her “iron stomach.” But then she felt so awful that she lay on the bathroom floor, sweaty and nauseous, for over an hour—and found she could not get up.
    • “That was when the alarm bells went off, though I couldn’t, even at that moment, imagine I was having a heart attack,” says Casalan, president of the UPS Store Inc. and a single mom to two boys who were 6 and 7 at the time. After all, she was just 47, active, and in generally good health. “And why would I think I was having a heart attack without chest pain?” 
    • “Casalan eventually got herself up and to her mom, who happened to be visiting that night, and from there “it was a total of about five minutes between the realization that I could be having a heart attack to unconsciousness.” Turns out she was suffering from full blockage in her left ascending artery—prompting a heart attack known as a “widowmaker”—which has just a 12% survival rate outside of hospitals for women. (Doctors have since theorized that it could’ve been brought on by having had an “overly inflamed” heart after a bout with COVID.)”
  • Per Medscape,
    • “A new study provides real-world evidence to support the potential repurposing of glucagon-like peptide 1 receptor agonists (GLP-1 RAs), used to treat type 2 diabetesand obesity, for prevention of Alzheimer’s disease (AD). 
    • “Adults with type 2 diabetes who were prescribed the GLP-1 RA semaglutide had a significantly lower risk for AD compared with their peers who were prescribed any of seven other antidiabetic medications, including other types of GLP-1 receptor–targeting medications. 
    • “These findings support further clinical trials to assess semaglutide’s potential in delaying or preventing AD,” the investigators, led by Rong Xu, PhD, with Case Western Reserve School of Medicine, Cleveland, Ohio, write. 
    • “The study was published online on October 24 in Alzheimer’s & Dementia.”
  • and
    • “For patients with metabolic dysfunction–associated steatotic liver disease (MASLD) and diabetes, treatment with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) may protect against progression to cirrhosis and mortality; however, the protective benefits do not extend to patients who already have cirrhosis, a new study found.”
  • The Wall Street Journal reports,
    • “Imagine being able to control a computer with your thoughts—even more easily and quickly than using your hands. That is the goal of Precision Neuroscience. Using brain-computer interfaces, it aims to transform the lives of people with physical challenges.
    • “The Wall Street Journal’s Rolfe Winkler spoke with Michael Mager, co-founder and chief executive of Precision Neuroscience, and Benjamin Rapoport, the company’s co-founder and chief science officer. [The article provides] edited excerpts of their discussion at the annual WSJ Tech Live conference.

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “HCA Healthcare took a $50 million financial hit in the third quarter due to the impacts of the back-to-back hurricanes Helene and Milton, which slammed facilities in North Carolina, Georgia and Florida.
    • “The for-profit health system told investors on Friday morning that it expects to feel the effects of the two storms in the fourth quarter as well, with additional hurricane-related costs likely to be between $200 million and $300 million, according to a press release.
    • “HCA noted that these projections do not account for insurance recoveries it may receive.” 
  • ‘Beckers Payer Issues tell us,
    • “Eighteen insurers have exited Medicare Advantage markets for 2025, with more than 1.8 million people currently enrolled in plans that will not exist next year, according to OliverWyman.
    • “Market exits by Humana, Aetna, and UnitedHealthcare collectively affect nearly 70% of those 1.8 million individuals.
    • “It’s important to highlight that these plan exits reflect members who will not be automatically moved into other products, even if one was available,” OliverWyman analysts wrote. “While these plan exits may seem alarming, carriers in many of these markets have introduced new products or have other products that members can switch to for 2025.”
  • Per Beckers Hospital Review,
    • ‘U.S. Bankruptcy Court Judge Christopher Lopez approved the sale of seven Dallas-based Steward Health Care hospitals to Healthcare Systems of America, an affiliate of Glendale, Calif.-based American Healthcare Systems during an Oct. 25 court hearing.
    • “Steward sought Chapter 11 protection May 6 and has been working to sell its 31 hospitals.
    • “The Steward hospitals are Houston-based St. Joseph Medical Center, Port Arthur-based Medical Center of Southeast Texas, Coral Gables (Fla.) Hospital, Hialeah (Fla.) Hospital, Miami-based North Shore Medical Center, Lauderdale Lakes, Fla.-based Florida Medical Center and Hialeah, Fla.-based Palmetto General Hospital. 
    • “Healthcare Systems of America has been interim manager of the hospitals and Steward’s West Monroe, La. -based Glenwood Regional Medical Center since Sept. 11.”

Midweek Update

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • On Wednesday morning, OPM’s supplemental Postal Service Health Benefits Program final rule was posted on the Federal Register’s Public Inspection List. The Federal Register version of the rule is being published on Thursday October 24, a week or so earlier than expected.
  • The final rule maintains OPM’s proposed exclusion of Part D eligible Postal annuitants from their PSHB plan’s prescription drug benefits in the event that they opt out of their Plan’s Part D EGWP benefits. A Part D EGWP integrates the Plan’s benefits with Medicare Part D benefits.
  • A Part D EGWP member subjected to the Part D EGWP penalty continues to pay the full employee / annuitant premium for FEHB coverage.
  • On the brighter side, the final rule does prohibit PSHB plans from auto enrolling Part D eligible annuitants who live overseas because they cannot receive Medicare Part D coverage. OPM also created an opportunity for Postal annuitants to reverse course and join the Part D EGWP if they realize that opting out was a mistake. See 89 Fed. Reg. 85012, 85022.
  • MedPage Today reports,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) on Wednesday endorsed additional doses of COVID vaccine for high-risk groups and recommended lowering the age for adult pneumococcal vaccination from 65 to 50 years.
    • “In an update to recommendations from June in three unanimous votes, ACIP recommended a second dose of the 2024-2025 COVID vaccine for adults ages 65 and older, as well as people ages 6 months to 64 years who are moderately or severely immunocompromised, and additional (three or more) doses for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision making.
    • “The advisors also voted 14-1 to recommend a pneumococcal conjugate vaccine (PCV) for all PCV-naive adults ages 50 and older.
    • “Shortly after the ACIP meeting, CDC Director Mandy Cohen, MD, MPH, endorsed the new COVID vaccine and pneumococcal vaccine recommendations.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Tuesday expanded the approval of Pfizer’s RSV vaccine Abrysvo to include adults aged 18 to 59 years who are at an increased risk of disease from respiratory syncytial virus.
    • “The vaccine was previously cleared in adults aged 60 years and older, as well as in pregnant women who are between 32- and 36-weeks’ gestation. With the latest expansion granted by the FDA, Pfizer claims its vaccine now holds the “broadest” indication for adults.
    • “In June, the Centers for Disease Control and Prevention tightened its guidance for RSV vaccination in older adults and delayed making recommendations for adults younger than 60. Advisers to the CDC are set to discuss RSV vaccine data this week but aren’t scheduled to vote on guidance for younger adults.”
  • Healthcare Dive lets us know,
    • “Centene is suing the federal government over its 2025 Medicare Advantage star ratings, the latest in a string of lawsuits from health insurers looking to protect their scores — and the valuable revenue they represent.
    • “The lawsuit filed Tuesday in a Missouri district court accuses the HHS of mishandling a “secret shopper” call meant to assess the quality of Centene’s customer call center, and unfairly including that call in the insurer’s ratings.
    • “Several of Centene’s plans received lower scores as a result, which could cost the insurer $73 million in revenue and cause enrollees to leave the plans — “staggering consequences” from a single call, according to the suit. Centene is requesting the judge order the CMS to recalculate its ratings without including the disputed call.”

From the public health front,

  • NBC News’ Today Show offers updated details on the McDonald’s E. coli outbreak.
  • NBC News reports,
    • Not having — or losing — your sense of smell may be linked to changes in breathing that could lead to depression, social isolation or other mental and physical health problems, a new study suggests. It’s more evidence of how important this often neglected olfactory sense is. 
    • A new analysis of breathing data from 52 volunteers over a 24-hour period revealed that people with a normal sense of smell had little spikes, or “sniffs,” during each breath that were not seen in those with no sense of smell, according to the report published in Nature Communications on Tuesday.” * * *
    • “The main takeaway from the study is better insight into some of the mental issues that some Covid patients who have lost their sense of smell experience, said the study’s lead author, Lior Gorodisky, a Ph.D. candidate in the brain sciences department at the Weizmann Institute of Science in Rehovot, Israel.” * * *   
    • “The little inhalations during a breath, known as the “sniff response,” are something that most of us experience unconsciously every day, Gorodisky said. Those little sniffs tell our brains about good and bad smells. “When you go to a bakery or a flower field, once your brain has sensed the good smell of a pastry or a flower, you immediately take a deeper breath,” Gorodisky said.”
        
  • The National Cancer Institute’s latest Cancer Information Highlights concern “Easing Money Troubles | Cachexia | Nutrition.”
  • Per an NIH press release,
    • “The National Institutes of Health (NIH) has launched a proof-of-concept precision medicine clinical trial to test new treatment combinations targeting specific genetic changes in the cancer cells of people with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The trial, funded by NIH’s National Cancer Institute (NCI), aims to accelerate the discovery of more tailored treatments for these aggressive cancers of the blood and bone marrow.
    • “NCI is uniquely positioned to conduct this type of study, which is one of a series of NCI precision medicine trials that are helping pave the way for more personalized treatment of cancer,” said W. Kimryn Rathmell, M.D., Ph.D., director of NCI. “By making these trials available to patients in communities around the country, we bring cutting edge science to people where they live and ensure that what we learn from our study participants can benefit patients like them in the future.”  * * *
    • “Learn more about myeloMATCH and the sub-studies that are currently open.”

From the U.S. healthcare business front,

  • Beckers Hospital Review identifies Healthgrades’ 50 top hospitals for surgical care, by state. 
  • Fierce Healthcare tells us,
    • “Sanford Health and Marshfield Clinic Health System have signed a merger agreement, the health systems announced on Wednesday, after first revealing their intent to combine in July.
    • “The systems said the combining would enable them to significantly improve the quality of care available to people living in the rural Midwest. Should the merger complete, the combined health system’s revenue would be about $10 billion.
    • “Sanford is the largest rural health system in the United States, including 45 hospitals, 211 clinics and more than 160 senior living centers. The Sioux Falls, South Dakota-based provider employs 2,900 physicians and advanced practice providers.
    • “Marshfield, meanwhile, has 60 clinics, 11 hospitals and a children’s hospital. It employs more than 1,700 providers, according to the announcement.
    • “Each also operates a health plan, and combined membership would top 425,000, the health systems said. * * *
    • “The deal is expected to close by the end of the year.”
  • Healthcare Dive informs us about “Executives from Amazon, Walgreens, Blue Shield of California and PhRMA [who] weighed in on how to fix the much-scrutinized pharmacy benefit manager model during HLTH 2024.”