Thursday Miscellany

CDC

Thursday Miscellany

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

David Ermer–CDC, Congress, Federal employment benefits, Generative AI, HSA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Roll Call reports,
    • “Sen. John Thune [R SD] on Wednesday was elected the next Senate majority leader, as Republicans are set to take over the chamber in January — and with a demanding President-elect Donald Trump poised to return to power.
    • “Having defeated Texas Sen. John Cornyn and Florida Sen. Rick Scott, the fourth-term South Dakotan will replace Mitch McConnell of Kentucky in January as the chamber’s top Republican. McConnell had held the top GOP spot since taking his party’s leadership reins in early 2007, making him minority leader in six Congresses and majority leader in three Congresses.
    • “Thune defeated Cornyn 29-24 on the day’s second ballot, with Scott eliminated from contention after the first ballot, according to a source inside the Capitol’s Old Senate Chamber, where Republicans chose their next leader.
    • “Senate Republicans also selected Sens. James Lankford, R-Okla., as Republican Conference vice chair; Shelley Moore Capito, R-W.Va., as Republican Policy Committee chair; John Barrasso, R-Wyo., as assistant majority leader; Tim Scott, R-S.C., as National Republican Senatorial Committee chair; and Tom Cotton, R-Ark., as Republican Conference chair.”
  • Tuesday night, the AP results for control of the House now stand at 218 Republicans vs. 208 Democrats with 218 seats constituting a majority. Decision Desk HQ already had awarded control of the House to the Republicans, 219 Republicans vs. 211 Democrats.
  • Federal News Network lets us know,
    • “The House passed the Social Security Fairness Act Tuesday evening in a vote of 327 to 75, bringing the removal of the Windfall Elimination Provision and the Government Pension Offset closer than ever to reality.
    • “Social Security’s WEP and GPO have been around for decades. The two provisions reduce and, in some cases, fully cancel out Social Security benefits for Civil Service Retirement System annuitants and other public sector employees who have worked in state and local government, as well as their spouses, widows and widowers.
    • “The House’s vote came after Reps. Abigail Spanberger (D-Va.) and Garret Graves (R-Pa.), the original cosponsors of the reintroduced Social Security Fairness Act, filed a discharge petition in September to try to push the bill toward a vote. About one week later, the petition reached the 218-signature threshold needed to force the bill to the House floor.” * * *
  • OPM yesterday released a fact sheet titled OPM Highlights its Key Actions under Biden Administration’s AI Executive Order.
  • Govexec tells us,
    • “The Office of Personnel Management reported a slight increase in the backlog of pending federal employee retirement claims in October, though still a marked improvement from the same period last year.
    • “OPM received 6,872 new retirement requests from departing federal workers last month, an increase of around 1,250 more claims than in September. Though OPM cleared 6,458 claims—itself an increase of around 150 claims from the previous month—the backlog ticked up by around 400 cases to 14,908. OPM’s goal is a “steady state” of 13,000 pending retirement claims.
    • “Despite that, the average time it takes to process a retirement claim fell from 63 to 62 days, as measured on a monthly basis.” * * *
    • Now the legislation faces its next hurdle: passage in the Senate. The Senate’s companion to the Social Security Fairness Act currently has 62 cosponsors. * * *
    • “Unlike the House, the Senate does not have a discharge petition procedure — the strategy that Spanberger and Graves used to force the floor vote in the House.
    • “In the Senate, we have the votes to defeat a filibuster, but it has to be brought to a vote,” John Hatton, NARFE’s staff vice president of policy and programs, told The Federal Drive with Tom Temin. “But somebody may object to proceeding, which could cause a two-week or so delay in getting it through.”
  • Per a government press release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), announced today the launch of the Behavioral Health Workforce Career Navigator, designed to help current and aspiring behavioral health professionals identify state requirements for a range of behavioral health careers. The navigator supports President Biden and Vice President Harris’ commitment to expanding America’s behavioral health workforce, a key element of the Administration’s Unity Agenda for the Nation.”

From the public health and medical research front,

  • National Institutes of Health Director Dr. Monica Bertagnolli writes in her blog, about “Advancing a Whole-Person Approach to Women’s Health Research.”
    • “NIH has committed $200 million in fiscal year 2025 to supporting cross-cutting research focused on the health needs of women. We also issued a Notice of Special Interest to highlight our interest in receiving project applications on diseases and conditions that impact women differently, disproportionately, and uniquely across nearly all NIH Institutes and Centers. We are already considering close to 300 new applications for women’s health research projects.
    • “The whole-person approach to women’s health allows researchers and clinicians to address unique needs throughout a woman’s lifetime and to provide a more complete picture of women’s health. It also must be integrated into all stages of the research process—from identifying innovative research questions, to producing impactful scientific and clinical results, to developing ways to equitably adopt new treatments. It begins with science that convenes researchers and clinicians from different disciplines to accelerate progress through combined efforts and knowledge. The White House Initiative on Women’s Health Research calls for this comprehensive approach, renewing NIH’s commitment to research that addresses the needs of women everywhere. It demands that we approach this work with urgency, putting women and their lived experiences at its center of a focus on translating insights from biology and society into better health.
    • “Links:
  • The Washington Post reports,
    • “A Canadian teenager infected with bird flu — that country’s first case involving a locally acquired infection — is in critical condition and experiencing difficulty breathing, health officials said Tuesday.
    • “The previously healthy British Columbia teen went to a hospital emergency room Nov. 2 with initial symptoms of pink eye, fever and cough, conditions common to many respiratory illnesses, Bonnie Henry, provincial health officer, said during a news conference. The teen was sent home.
    • “But after the patient’s condition deteriorated, the teen was admitted to BC Children’s Hospital in Vancouver late Friday.
    • “So far, no one who came into contact with the teen has fallen ill.” * * *
    • “On Wednesday, the Public Health Agency of Canada confirmed the H5N1 diagnosis in the teen and said genomic sequencing indicates the virus is related to the bird flu viruses from the ongoing outbreak in poultry in British Columbia, which is related to wild birds.”
  • STAT News informs us,
    • “U.S. drug overdose deaths are plummeting, putting the country on pace for its first year with fewer than 100,000 overdose deaths since 2020 — a powerful, if bleak, symbolic milestone.
    • “Reported drug deaths fell nearly 17% during the 12-month period ending in June, to 93,087, according to new statistics released this week by the Centers for Disease Control and Prevention. 
    • “The epidemic’s toll remains immense but is substantially lower than the 111,615 lives lost to overdose during the 12 months ending in June 2023. Fentanyl, the potent illicit opioid that now dominates the U.S. illicit drug supply, contributed to a large majority.” 
  • Per Health Day,
    • “Even as the pressures of the pandemic began to ebb, Americans’ growing dependence on alcohol did not, a troubling new study shows.
    • “Two years into the globe-altering health crisis, the percentage of Americans who consumed alcohol — which had already spiked between 2018 and 2020 — inched even further up in 2021 and 2022. Not only that, but more folks reported heavy or binge drinking, the findings published Tuesday in the Annals of Internal Medicine revealed.
    • “Our results provide national data to draw further attention to the potential alcohol-related public health effects that may remain from the pandemic,” the researchers wrote in their research. “Potential causes of this sustained increase include normalization of and adaptation to increased drinking due to stress from the pandemic and disrupted access to medical services.” 
  • Per MedTech Dive,
    • “Livanova said Monday a trial of its obstructive sleep apnea (OSA) implant met its primary safety and efficacy endpoints, positioning the company to seek approval once the analysis is complete.  
    • “The randomized trial linked Livanova’s aura6000 to improvements on measures of OSA severity and blood oxygen after six months of treatment with the hypoglossal nerve stimulator. The hypoglossal nerve controls the tongue muscles.
    • “Leerink Partners analysts said the results were largely in line with outcomes seen in a trial of Inspire Medical Systems’ rival device. The analysts see ways that Livanova could differentiate its device but said the company “may have a difficult time breaking into the sleep apnea market.”
  • Fierce Pharma points out,
    • “Following an impressive data drop this summer highlighting the potential for Eli Lilly’s tirzepatide to stave off progression to Type 2 diabetes in prediabetic patients, the Indianapolis-based drugmaker is laying out full results from its longest completed study of the dual GIP/GLP-1 receptor agonist to date.
    • “In the three-year SURMOUNT-1 trial, tirzepatide curbed the risk of disease progression to Type 2 diabetes by 94% versus placebo in adult prediabetes patients who were obese or overweight, Lilly said in a release Wednesday. The number represents a pooled result from three tirzepatide doses (5 mg, 10 mg and 15 mg) studied in the trial.
    • “Putting those results into perspective, one new case of diabetes could be prevented for every nine patients treated with tirzepatide, which is marketed in the U.S. as Mounjaro for Type 2 diabetes and as Zepbound for obesity, Lilly said.
    • “Overall, nearly 99% of patients on tirzepatide remained diabetes-free at the end of the trial’s 176-week treatment period, the company added. 
    • ‘Further, at the 193-week mark, which followed a 17-week off-treatment follow-up period, only 2.4% of patients on Lilly’s drug were diagnosed with Type 2 diabetes compared to 13.7% of patients in the study’s placebo cohort.
  • Beckers Hospital Review identifies “nine new drug shortages to know, according to databases compiled by the FDA and the American Society of Health-System Pharmacists.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Self-funded employer clients of Aetna have access to SimplePay Health, a new healthcare plan design that provides employees and other plan members with essentially an interest-free line of credit to pay for care and requires no out-of-pocket costs due at the time of service, Aetna said in a Oct. 15 press release.
    • “The plan requires only copays for medical services and prescription drugs up to the plan member’s out-of-pocket maximum, with no deductibles or coinsurance costs. Each plan member is mailed a monthly statement — which Aetna compared to a credit card statement — that summarizes all medical and pharmacy claims from the prior 30 days.
    • “Payment terms are generally chosen by the plan sponsor, Amie Benedict, president, diversified commercial solutions at Aetna, said in an email to HR Dive, but payment plans are generally between 12 to 18 months long. “SimplePay will work with members requiring longer payment periods,” Benedict said.” * * *
    • “Aside from SimplePay, UnitedHealthcare company Surest also offers a plan model to self-funded employers without coinsurance or deductibles.
    • “Jim Winkler, chief strategy officer at the Business Group on Health, said in an interview that SimplePay, Surest and similar products are designed to curate a set of preferred healthcare providers and encourage plan members to use these providers by keeping down out-of-pocket costs.
    • “This is especially the case for “shoppable” care, or care that is neither urgent nor emergency in nature and for which employees can select from a variety of providers, Winkler said. “In these shoppable moments, these programs are designed to ensure that the right choice is the easy choice.”
  • Fierce Healthcare fills us in on the first day of its Fierce Health Payer Summit here in beautiful Austin Texas.
  • Corporate Synergies exposes “The Myths Preventing Employees from Embracing HSA-Qualified Plans.”
  • Per BioPharma Dive,
    • “BioNTech is buying into one of the hottest areas of oncology, agreeing to pay $800 million to acquire China-based Biotheus and, with it, a type of drug some analysts think could rival Merck & Co.’s dominant immunotherapy Keytruda.
    • “The deal will hand BioNTech full global rights to a dual-targeting drug that’s designed to block two proteins: the PD-L1 “checkpoint” targeted by Keytruda and another called VEGF that’s coopted by tumors to fuel their growth.
    • “This specific type of “bispecific antibody” is newly on drugmakers’ radar screens after Summit Therapeutics wowed the cancer field with data showing its drug ivonescimab outperformed Keytruda in a head-to-head lung cancer trial.”

Tuesday Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Happy Veterans Day!

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

Thanks to all those who served our great country.

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.”

Thursday Miscellany

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Medical / Rx research, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Susie Wiles, who led Donald Trump’s presidential run, will become his White House chief of staff when he retakes the presidency next year, the campaign said Thursday, making her the first woman to hold that role in U.S. history. * * *”
    • “Those who have worked with her say she is unflappable behind her trademark mirrored sunglasses, avoids the limelight and is quick to give her team credit for her stack of victories.
    • “Every campaign she’s been involved with, she’s been a calming presence,” longtime Florida lobbyist and Wiles ally Brian Ballard told the Journal. “He saw in her the DNA of a winner.”
  • Federal News Network interviews principal Thiago Glieger, a principal of RMG Advisors about getting organized for the Federal Employee Benefits Open Season, which starts next Monday.
  • The Wall Street Journal reports,
    • “U.S. health officials proposed banning an ingredient used in popular oral decongestants, a step toward removing dozens of cold medicines from store shelves. 
    • “The Food and Drug Administration on Thursday proposed removing the ingredient, known as oral phenylephrine, from its list of approved over-the-counter ingredients after determining the drug doesn’t work at relieving stuffy noses.
    • “The agency took action after The Wall Street Journal had reported that some recent studies found oral phenylephrine in certain medicines was ineffective at relieving nasal congestion. CVS Health had already said it would pull some decongestants containing phenylephrine and no longer sell them. 
    • “After taking public comment, the FDA could issue a final decision that would end sales of medicines containing the ingredient, including certain versions of Benadryl, Mucinex and Tylenol. The agency said it would give drugmakers time to remove the products from the market or reformulate them. 
    • “The earliest a potential ban would take effect is 2026.
    • “Instead of taking pills that contain phenylephrine to clear congestion, people can take pills made from pseudoephedrine, antihistamines or nasal sprays, including those with phenylephrine. Physicians and pharmacists say the alternatives are effective.”
  • Beckers Hospital Review adds,
    • “The FDA has updated the labels for all GLP-1 receptor agonists, including popular medications Ozempic, Wegovy, Saxenda and Mounjaro, to include a new warning about the risk of pulmonary aspiration during general anesthesia or deep sedation, Medscape reported Nov. 6. 
    • “The updated warning, issued Nov. 5, stems from rare postmarketing reports of patients who experienced pulmonary aspiration, when food or liquid enters the lungs, while undergoing elective surgeries or procedures requiring anesthesia despite following fasting guidelines prior to surgery.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) released the 2021–2023 Progress Report – PDF for the Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. The progress report provides a high-level overview of progress on select federal agency programs, policies, research, and other activities during fiscal years 2021–2023.”
    • “The progress report features an at-a-glance table of the status of seven core indicators and seven disparities indicators, which were identified in the national plan as a quantitative approach to measuring progress on STI prevention and care in the United States. The most recently available data reveal that seven of the indicators have met or are moving toward annual targets and that seven have not met or are moving away from annual targets. Of this latter group, six indicators relate to syphilis, which is the focus of the National Syphilis and Congenital Syphilis Syndemic Federal Task Force led by HHS Assistant Secretary for Health, Admiral Rachel Levine, M.D.”

From the public health and medical research front,

  • Health Day tells us,
    • “Nearly 16% of American adults — that’s close to 1 in 6 — now has diabetes, according to the latest data from the U.S. Centers for Disease Control and Prevention.
    • “Increasing age and widening waistlines greatly increase the odds for the disease, which happens when the body doesn’t use insulin properly, resulting in high blood sugar levels. If left unchecked, diabetes can be disabling and even life-threatening.
    • “The vast majority (95%) of diabetes cases are type 2 diabetes, which occurs when the body’s cells no longer respond to insulin as they should. Insulin regulates levels of sugar in the blood. Type 2 diabetes is strongly connected to excessive weight. 
    • “The new data, collected from mid-2021 through mid-2023, found a big rise in diabetes rates since 1999-2000, when 9.7% of adult Americans had the disease.
    • ‘There was a significant gender gap in diabetes rates in 2023: Nearly 1 in 5 men (18%) have the illness, compared to 13.7% of women, according to researchers at the CDC’s National Center for Health Statistics (NCHS).”
  • and
    • “A simple nasal swab might help doctors predict the severity of a person’s COVID infection, a new study suggests.
    • “More than 70% of people with mild or moderate COVID develop certain antibodies in their nasal cavities that are linked to fewer symptoms, better immune response and faster recovery, researchers reported Nov. 6 in the journal Science Translational Medicine. * * *
    • “Researchers are working on a nasal swab test that could be used to predict how bad a person’s COVID infection will prove to be.
    • “Right now, we’re either looking at infection risk before it happens or analyzing the infection course well after recovery,” said researcher Ben Babcock, a doctoral candidate at Emory. “Imagine if we could capture the immune response in real time, right in the clinic. A just-in-time test could give physicians and patients the real-time information they need to make faster, smarter treatment decisions.”
  • STAT News informs us,
    • “For months, as human cases of H5N1 bird flu associated with an outbreak of the virus in U.S. dairy cattle have mounted, one question has loomed larger than others: how many human infections are getting missed?
    • “Farmworkers face some of the most intense exposure to the bird flu virus, but resistance from farmers and a lack of health insurance and paid sick leave in the industry have limited the amount of testing of workers and hampered public health officials’ ability to track where the virus might be spreading. Now, long-awaited results from blood testing conducted by the Centers for Disease Control and Prevention are starting to fill in the picture.
    • “The findings, published Thursday, suggest that a small but not insignificant number of H5N1 infections are going undetected among people who work with dairy cows. Blood samples taken from 115 farm workers in Michigan and Colorado over the summer found evidence of a recent infection in eight individuals — half of whom recalled being ill around the same time the cows were sick. The other half could not recall having any symptoms.
    • “Known as serological surveys, the studies involve fishing out antibodies in the blood — molecules made by the immune system in response to a pathogen’s attack that persist long after an infection is over. Finding them is a signal of past contact with a particular virus and helps scientists understand how widely it has spread. 
    • “While the new results suggest that current public health efforts are missing cases, they do not indicate that the strain of H5N1 associated with the dairy cattle outbreak has gained the ability to spread from person to person.”  
  • NBC News reports,
    • “Brie and camembert that may potentially be contaminated with listeria are being recalled, the latest in a series of food incidents in the U.S. in recent months.
    • “Savencia Cheese USA is recalling select soft ripened cheeses after routine testing found the processing equipment at the company’s Lena, Illinois, manufacturing facility may have been contaminated with the bacteria.
    • “Aldi and Market Basket, a supermarket chain in New England, are among stores that sell the cheeses, but the recalled products only had “limited regional distribution” in the U.S., according to the U.S. Food and Drug Administration. 
    • “The “few retailers” that received them have been informed of the possible contamination and are removing products from shelves, the FDA added.
    • “There are no confirmed reports of anyone getting sick so far, the agency noted.”
  • NIH Director Dr. Monica Bertagnolli writes in her blog,
    • “Digestion involves much more than just your stomach. The digestive process that fuels your body begins in your mouth each time you take a bite of food and chew. An enzyme in your saliva, called amylase, then starts to break down complex carbohydrates—or starches found in many fruits, vegetables, and grains—into simpler sugars to give you their sweet flavor followed by a burst of energy.
    • “Amylase is the reason we’re so good at turning starch into calories, but it isn’t the same for everyone. There’s plenty of genetic variation in the number of salivary amylase genes (AMY1) our cells carry and, therefore, in how much of this essential starch-busting enzyme people have. Studies have suggested a link between changes in amylase gene copy numbers over time and both the rise of agriculture and starch-heavy diets. Now a study in Science , supported in part by NIH, suggests that extra copies of AMY1 are not only connected to our ability to effectively digest carbs, but also may be more ancient than previously known, arising even before modern humans split from Neanderthals and long before the advent of farming.” * * *
    • ‘The researchers compared the modern-day amylase genes to publicly available DNA sequences from 68 ancient human samples obtained from preserved remains. This revealed that ancient hunter-gatherers already had six to eight AMY1 copies long before people started growing crops and eating high amounts of starch. In fact, genetic variation underlying the production of this enzyme had already spread across Eurasia as far back as 45,000 years ago. However, the new analyses do show an increase in amylase gene copy numbers in the last 4,000 years, as people took up farming.
    • “The study team went on to uncover evidence that the expansion of amylase genes apparently has a longer history than anyone had suspected. Intriguingly, they found three copies of AMY1 in the DNA of three of six Neanderthals and one Denisovan. Neanderthals and Denisovans are both extinct relatives of early humans. The findings suggest that an extra copy of the amylase gene may have arisen as long as 800,000 years ago. The researchers also described how those first extra AMY1 copies could lead to their continued duplications or deletions to produce the wide variation in amylase gene copy numbers seen among modern humans.
    • “This variation in amylase genes would have afforded our ancestors dietary flexibility, allowing them to adapt as diets changed over time. But these discoveries aren’t only fascinating from an evolutionary or historical point of view. They may also lead to new understandings of genetic differences among people today, with potentially important implications for our metabolisms, nutrition, and health.”
  • The Washington Post reports,
    • “Regular practice of yoga can reduce lower-back pain, improve sleep and lessen reliance on pain medication, according to a study conducted by Cleveland Clinic researchers.
    • “The randomized clinical trial studied 140 Cleveland Clinic employees who had disclosed moderate amounts of pain for at least three months. Participants who engaged in a 12-week virtual yoga program reported feeling less pain and better sleep when compared with those who did not have access to the program.”

From the U.S. healthcare business front,

  • Modern Healthcare lets us know,
    • “Private equity firms are shifting their focus from providers to healthcare information technology and pharmaceutical services.
    • “State and federal regulatory scrutiny has deterred private equity investment in healthcare providers, PitchBook analysts said in the company’s latest healthcare services report. But regulatory oversight of healthcare-related private equity deals has slightly cooled as certain state bills stalled in the 2024 legislative session, and the report says analysts expect more private equity activity through the rest of the year.”
  • The American Hospital Association News relates,
    • “Baxter expects to restart a second IV solutions manufacturing line within the next week, the company announced Nov. 7. Along with the first line that resumed production last week, the two lines comprise approximately 50% of the North Cove, N.C., site’s total pre-Hurricane Helene production of IV solutions and about 85% of one-liter solutions production. Hospitals in clinics most commonly use the one-liter solutions. The earliest the facility could begin shipments is late this month.
    • “The company said they expect their peritoneal dialysis and irrigation solutions lines to be the next to resume production and would begin by early December. Baxter expects all lines to restart by the end of the year but does not have a timeline on when total production will return to pre-hurricane levels. The company also said today that it has evaluated and approved more than 200 allocation exception requests to support the neonatal and pediatric patient needs.
    • “In addition, Baxter announced that a second temporary bridge has been installed at the plant and is in use. The bridge will allow traffic for additional trucks and equipment. The first bridge so far has allowed transport of more than 1,000 truckloads of products, Baxter said. Prior to the hurricane, the plant had manufactured approximately 60% — or 1.5 million bags or 95 truckloads — of IV solution used every day in the U.S.”
  • Beckers Payer Issues ranks the largest payers by 3rd quarter profits.
  • Per Fierce Healthcare,
    • “CerpassRx, an independent pharmacy benefit manager, is teaming up with Waltz Health to launch a new AI-powered tool that aims to better manage specialty drug spending.
    • “Called Intelligent Specialty Engine, the tool leans on Waltz’s capabilities to offer clients real-time data analytics and management options that are designed to drive down spending, create greater transparency and improve the experience for both the patient and the plan sponsor.
    • “The PBM said that the platform is a “unique deployment” of Waltz Health’s Waltz Connect platform, which connects users to a network of both national and regional pharmacies that compete on price. It uses AI to help steer patients to “the most cost-effective and clinically appropriate pharmacies.”
  • Per BioPharma Dive,
    • “Sarepta Therapeutics is giving up on an experimental drug for Duchenne muscular dystrophy as sales rocket for its approved gene therapy for the disease.
    • “The decision to discontinue SRP-5051 was based on several factors, company executives told analysts on a conference call Wednesday. Safety concerns, feedback from the Food and Drug Administration and the “evolving landscape of Duchenne” with the approval of Sarepta’s gene therapy Elevidys all played a role, Chief Scientific Officer Louise Rodino-Klapac told analysts and investors.
    • “Elevidys revenue climbed to $181 million in the third quarter from $122 million in the second quarter, beating analyst estimates of about $160 million. Sarepta also pulled in $9.5 million in royalties from Roche, which sells the gene therapy outside the U.S.“
  • Per Fierce Pharma,
    • “Despite a mission to become a dominant cancer drug player, Gilead Sciences has as of late been locked in on its bread-and-butter antiviral franchise with an eye on the potential of its long-acting HIV med lenacapavir. 
    • “But with its cell therapy unit stalling and antibody-drug conjugate Trodelvy facing challenges, the company’s oncology ambitions were brought back under the spotlight during its third-quarter earnings report.
    • “Gilead’s once fast-growing cell therapy products have hit a wall as of late with relatively flat sales all year. Over the third quarter, lymphoma treatment Yescarta saw revenue dip 1% to $387 million compared to last year’s third quarter, while its Tecartus counterpart similarly remained flat with 2% growth to $98 million.
    • “Gilead attributed the Yescarta challenges to “increased in- and out-of-class competition” in the U.S., slightly offset by increased demand in relapsed or refractory large B-cell lymphoma (LBCL) in other regions. In terms of the outside competition, one notable rival includes Bristol Myers Squibb’s rival CD19 CAR-T Breyanzi.”
  • Per MedTech Dive,
    • “Johnson & Johnson received Food and Drug Administration approvalfor its Varipulse pulsed field ablation (PFA) system, joining Boston Scientific and Medtronic in the U.S. market for the fast-growing atrial fibrillation (AFib) treatment.
    • “Varipulse is approved to treat patients with drug-resistant, recurrent paroxysmal AFib, a common form of abnormal rhythm in the heart’s upper chambers, the company said Thursday. The platform is integrated with J&J’s Carto 3 mapping system in a single device that enables electrophysiologists to view inside the heart to position the catheter. 
    • “We are confident that this eagerly awaited platform will be a valuable tool for physicians in performing safe, effective and efficient AFib procedures with an intuitive and reproducible workflow,” Jasmina Brooks, president of electrophysiology at J&J Medtech, said in a statement.”

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.”

Tuesday Tidbits

David Ermer–CDC, CMS, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Reuters reports,
    • “Journey Medical (DERM.O) said on Monday the U.S. Food and Drug Administration has approved its drug for the treatment of a long-term skin condition called rosacea.
    • “Rosacea is a skin condition causing chronic inflammation of the facial skin and is often classified into four types.
    • “The oral antibiotic, branded Emrosi, was approved to treat lesions associated with inflammatory rosacea, which causes persistent redness and small pus-filled bumps on the face.”
  • Per Federal News Network,
    • “Of all the areas the Federal Employee Viewpoint Survey (FEVS) measures, federal employees’ views of senior leadership may be one of the trickier categories to unpack.
    • “The “leaders lead” category on FEVS typically results in lower scores from federal employees than the category measuring views of immediate supervisors. But the senior leadership score for this year’s survey still increased from 61% to 63% between 2023 and 2024, the Office of Personnel Management reported last month. Looking back a bit further, employees’ views of senior leadership have risen 4% since 2022.
    • “It’s certainly a positive finding in the governmentwide results of the 2024 FEVS, but looking more deeply at the survey results, there appears to be variation based on how closely situated employees are to their agency’s headquarters.
    • “In a FEVS data dashboard, OPM’s breakdown of results by each Federal Executive Board (FEB) geographic region shows that federal employees located in the “Eastern” FEB — or those closer to many agency headquarters — have higher scores than those working in the areas covered by the Western FEB, who are for the most part geographically farther from headquarters.”
  • From the public health and medical research front,
  • The American Hospital Association lets us know,
    • “Reports of cases of pertussis, also known as whooping cough, are currently five times higher compared to last year, according to the Centers for Disease Control and Prevention. The rise indicates the U.S. is returning to pre-pandemic patterns of typically 10,000-plus cases each year, and that mitigation measures such as masking and remote learning during the pandemic lowered transmission, the CDC said. The agency said that vaccination is the best way to prevent pertussis, but it expects cases to continue to increase among vaccinated and unvaccinated populations.” 
  • The Wall Street Journal adds,
    • “If you’ve had a lingering cough recently, there is a chance the culprit wasn’t Covid-19, flu or RSV, but mycoplasma pneumoniae.
    • “Levels of this milder lung infection—which can lead to “walking pneumonia”—are 10 times greater than last year, according to the Centers for Disease Control and Prevention [“CDC”]. Though the CDC doesn’t officially track the disease, it issued an alert last month noting the rise in cases. Levels of walking pneumonia, so named because patients often feel well enough to go about their normal daily activities, typically peak every three to seven years.
    • “Chris Edens, lead of the CDC team that tracks Legionella and atypical pathogens, said the agency saw a rise of cases in late spring. It peaked in August, then declined a bit. The decrease might not last, he adds, noting “levels seem to be flattening out or maybe even ticking back up.”
    • “Cases of walking pneumonia are up across all age groups, with children 17 and under experiencing the largest rise, says Edens.”
  • The CDC reminds us that November is diabetes month. The agency offered its quick pre-diabetes test.
  • BioPharma Dive tells us,
    • “A medicine built around a more precise form of CRISPR gene editing appeared to work as designed in its first clinical trial test, developer Beam Therapeutics said Tuesday. But the death of a trial participant could renew concerns about an older drug used alongside Beam’s genetic medicine.
    • “Beam’s medicine uses a technology known as base editing to activate a gene in stem cells collected from people with sickle cell disease, an inherited blood condition that can cause debilitating pain and a constellation of other symptoms.
    • “Data shared by Beam from the first handful of patients treated in the trial show the company successfully edited those cells in a laboratory. When later reinfused back into patients’ bodies, they matured into red blood cells that were more durable and less likely to warp into the sharp-edged crescents associated with the disease.
    • “However, one of the patients died from lung damage that was judged by their physician and the trial’s monitoring committee as related to an old chemotherapy drug commonly used prior to stem cell transplants. The Food and Drug Administration also reviewed the case. 
    • “Called busulfan, this drug is known to be toxic. But it is effective at creating an opening in the bone marrow for newly edited stem cells to take root, a necessary step for infusing gene editing therapies like Beam’s.
    • “Beam is working on a solution to sidestep busulfan and, on Tuesday, also released data from testing in monkeys showing how it may work.”
  • Per Medpage Today.
    • “Greater use of virtual mental health care services was linked to a lower risk of suicide-related events, according to a retrospective cohort study.
    • “The study of more than 16,000 veterans with prior mental health diagnoses showed that a 1% increase in the proportion of mental health care received through telehealth services was associated with a 2.5% decrease in suicide-related events, Kertu Tenso, PhD, of Boston University School of Public Health, and co-authors reported in JAMA Network Open.”
  • Per Healio,
    • “Ex-smokers with a light lifetime smoking burden had a CVD [cardiovascular disease] risk shortly after quitting similar to those who have never smoked, results from a cohort analysis showed.
    • “However, findings from the retrospective study suggest that ex-smokers who smoked heavily may need to restrain from smoking for more than 25 years to have a cardiovascular risk similar to those who have never smoked.”
  • MedCity News suggests “A Recipe for Better Obesity Care: Integrating GLP-1s with Food as Medicine. Nutrition isn’t a supplement — it’s foundational to metabolic health. It’s time we integrate more ‘Food as Medicine’ initiatives alongside the GLP-1 therapies that are gaining traction.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Three independent pharmacies have filed separate lawsuits accusing GoodRx, which markets a prescription drug discount card, of conspiring with several pharmacy benefit managers to fix reimbursement fees, the latest skirmish over the opaque pharmaceutical supply chain in the U.S.
    • “At issue are the behind-the-scenes transactions involving generic drugs, which account for an estimated 90% of the prescriptions written in the U.S. and, consequently, represent a lucrative market. The lawsuits claim, however, that GoodRx and some of the largest PBMs coordinate their reimbursement policies in a way that has deliberately reduced fees for the pharmacies.”
    • “The “anti-competitive” tactic has contributed to deteriorating finances for a growing number of independent pharmacies, according to the lawsuits, which noted “thousands” of local drug stores have closed in recent years. The pharmacies argued the dispute is one of several over reimbursement fees that, ultimately, favor pharmacies affiliated with the PBMs themselves.
    • “The upshot of this scheme is that the conspiring PBMs, by coordinating their reimbursement decisions through GoodRx, never pay pharmacies more for generic drugs than any rival PBM has agreed to pay in its separate negotiations with those pharmacies. This is nothing more than price fixing,” argued a lawsuit filed by Community Care Pharmacy, which is based in Michigan and sued only GoodRx.”
  • Modern Healthcare informs us,
    • “Signify Health is tapping into resources from parent company CVS Health to grow the number of in-home services it can provide.
    • “Signify conducts in-home health evaluations for patients, and if needed, connects them to primary care or other follow-up services. It works with health plans to identify members who could benefit from an evaluation. CVS acquired Signify a year-and-a-half ago in a $8 billion deal, just a couple of months before closing a $10.6 billion acquisition of primary care provider Oak Street Health.
    • “Joining CVS — which also includes the core retail pharmacy, insurer Aetna and pharmacy benefit manager Caremark — brought Signify into a larger ecosystem with opportunities to increase its care coordination offerings. In October, CVS ousted former CEO Karen Lynch, who oversaw the Signify deal and other efforts to diversify the parent company’s assets.
    • “That hasn’t affected Signify President Paymon Farazi’s plans to expand the kinds of services the company can provide as part of its in-home health evaluations. Farazi said in an interview his aspirations for Signify range from adding more diagnostic tests to moving into clinical care.”
  • MedCity News discusses five healthcare companies which attracted one of its journalist’s attention at the HLTH24 conference.
  • Per MedTech Dive,
    • “The Centers for Medicare & Medicaid Services granted transitional pass-through (TPT) payment status to Medtronic and Recor Medicalfor renal denervation devices to treat high blood pressure.
    • “The TPT program provides additional funding to hospitals to encourage use of new Food and Drug Administration-approved therapies as the CMS gathers cost data to determine future reimbursement rates under the Medicare outpatient prospective payment system. The companies announced the coverage decisions on Friday.
    • “Jason Weidman, president of Medtronic’s coronary and renal denervation business, called the payment approval for the Symplicity Spyral catheter an “important milestone” for the company’s renal denervation procedure because it will reduce cost barriers for healthcare systems. The company has pegged the market as a $1 billion-plus opportunity.”
  • Beckers Hospital Review relates,
    • “Altamonte Springs, Fla.-based AdventHealth has partnered with Walmart to open a hybrid primary care clinic inside one of its stores [located in Corbin, Kentucky]. * * * Since Walmart shuttered its own retail health clinics and virtual care service, it has been leasing space to health systems, including Chesterfield, Mo.-based Mercy.”

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.

Friday Factoids

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

From Washington, DC

  • NBC 10 Buffalo NY reports
    • Capital District Physicians’ Health Plan (CDPHP) will no longer be offering its plan for Federal Government employees. A spokesperson for CDPHP said this affects about 6,000 members.
    • “At the beginning of 2024, due to compounding regulations and rising administrative costs, CDPHP made the difficult decision to exit the Federal plan at the end of this plan year,” said the spokesperson. “Federal plan employees will need to select a new plan/carrier during this year’s Open Season.”
    • The FEHBlog remembers an OPM FEHB carrier conference which featured a CDPHP speaker due to the quality of the Plan’s services.
    • OPM does pile benefit and administrative costs on FEHB carriers. The straw that may have broken the camel’s back was OPM’s January 2023 mandate to cover GLP-1 drugs for obesity. That unexpected cost still reverberates in FEHB premiums today.
    • The FEHBlog is not saying that OPM should not have mandated GLP-1 drugs for obesity. The FEHBlog is saying that OPM should have put that mandate in a call letter for benefit and rate proposals so that plans could build the cost into their premiums as federal procurement law requires.
  • The OPM Inspector General weighed in again on the Postal Service Health Benefits Program implementation process.
  • The Miller and Chevalier law firm lets us know,
    • “On October 17, 2024, the Internal Revenue Service (IRS) issued Notice 2024-75 to expand preventive care benefits permitted by a high deductible health plan (HDHP) under section 223(c)(2)(C) of the Internal Revenue Code. The guidance states that over-the-counter (OTC) contraceptives and male condoms, types of breast cancer screenings beyond mammography, and certain types of diabetes care all qualify as preventive care.” * * *
    • “Notice 2024-75 is generally effective for plan years that begin on or after December 30, 2022.”
    • “In related concurrent guidance, the IRS issued Notice 2024-71, which provides a safe harbor for amounts paid for condoms by use by the taxpayer, spouse, or dependent under section 213(d) of the Code. “
  • The American Hospital Association tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 25 launched a preview of health coverage options available through the Open Enrollment Period for the HealthCare.gov marketplaces, set to open on Nov. 1. The Administration also announced Deferred Action for Childhood Arrivals recipients will be eligible to enroll in a marketplace plan and may be eligible for other benefits to lower health insurance out of pocket costs. As part of this year’s open enrollment, CMS updated the HealthCare.gov webpage and made it mobile-friendly to ease the enrollment process. The ACA marketplace open enrollment runs from Nov. 1 to Jan. 15.”
  • Here is a link to the related CMS fact sheet.
  • Per JD Supra,
    • “On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health programs for medically unnecessary urine drug tests and provided illegal kickbacks to physicians.
    • “Precision Toxicology, headquartered in San Diego, CA, is one of the nation’s largest urine drug testing laboratories. According to the fact recitation in the settlement documents, Precision allegedly submitted false claims for drug tests to Medicare, Medicaid, TRICARE, the Federal Employees Health Benefits Program (FEHBP), and the Department of Veterans Affairs (VA) for a period of approximately 10 years. The drug test claims submitted to the programs were allegedly medically unreasonable and unnecessary. Specifically, Precision allegedly utilized nonallowable blanket orders for urine drug tests without physician authorization and offered free point-of-care drug test cups to physicians in exchange for referrals, in violation of the Anti-Kickback Statute.”

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 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. Nationally, COVID-19 infections are predicted to be growing slowly from a low level.
      • “The XEC variant is predicted to increase to 14-22% among 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 is low. However, signs of increased RSV activity have been detected in the southeastern U.S., particularly in young children.
    • “Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • Wastewater detections [of the COVID virus] remain at low levels nationally, but detections tracking a bit higher in the West and Midwest compared to other regions, according to CDC data. Similarly, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, said its monitoring has the nation at the medium level, with a downward trend over the past 3 weeks. It said the South and West are now in the low category.
  • The Food and Drug Administration informs us,
    • “Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. McDonald’s has temporarily stopped using Quarter Pounder slivered onions and beef patties in affected states. Diced onions and other types of beef patties used at McDonald’s have not been implicated in this outbreak. Additionally, Taylor Farms has initiated a voluntary recall of some onions sent to food service customers. Customers who are impacted have been contacted directly. As of Oct. 24, 75 people infected with the outbreak strain of E. coli O157:H7 have been reported from 13 states. Illnesses started on dates ranging from Sept. 27, 2024, to Oct. 10, 2024. Of 61 people with information available, 22 have been hospitalized and two people developed hemolytic uremic syndrome, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. Of the 42 people interviewed, all 42 (100%) report eating at McDonald’s and 39 people report eating a beef hamburger. Consumers who have already eaten at McDonald’s and have symptoms of E. coli infection should contact their health care provider to report their symptoms and receive care immediately. The FDA is working closely with the U.S. Department of Agriculture, the Food Safety and Inspection Service, the Centers for Disease Control and Prevention and state partners to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. Additional information will be published in the advisory as it becomes available.” 
  • The American Medical Association offers “top health tips that pediatricians want parents to know.”
  • Per Fierce Pharma,
    • “Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem.
    • “Sulopenem, which will now go by the commercial moniker Orlynvah, was approved by the FDA Friday to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative antibacterial treatment options.
    • “The FDA nod—Iterum’s first—marks the second approval this year for a uUTI medicine after two decades of stagnation in the field. It also represents the first U.S. approval for an oral penem—a class of antibiotics.
    • “Back in April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam). The penicillin antibiotic underpinning Utility’s drug had never before been cleared in the U.S., despite being approved in Europe for more than 40 years.”
  • Medscape tells us,
    • “The incidence of atrial fibrillation (AF) is on the rise, and recent joint guidelines from the American College of Cardiology and American Heart Association (ACC/AHA) stress the role of primary care clinicians in prevention and management.
    • “One in three White and one in five Black Americans will develop AF in their lifetime, and the projected number of individuals diagnosed with AF in the United States is expected to double by 2050.
    • “Cardiologists who spoke to Medscape Medical News said primary care clinicians can help control AF by focusing on diabetes and hypertension, along with lifestyle factors such as diet, exercise, and alcohol intake.
    • “It’s not just a rhythm abnormality, but a complex disease that needs to be addressed in a multidisciplinary, holistic way,” said Jose Joglar, MD, a professor in the Department of Internal Medicine at the UT Southwestern Medical Center in Dallas and lead author of the guidelines.
    • Joglar said primary care clinicians can play an important role in counseling on lifestyle changes for patients with the most common etiologies such as poorly controlled hypertension, diabetes, and obesity.”
  • STAT News lets us know,
    • “For people with obesity, surgeries that shrink, reshape, or otherwise alter the anatomy of the stomach have long reigned supreme as the surest way to weight loss. But in the last few years, with the approval of GLP-1 drugs like Wegovy and Zepbound, more and more people are opting for obesity medicines over gold-standard surgical treatments. 
    • “On a population level, among a subset of commercially insured individuals, that is the tradeoff that is happening” said Thomas Tsai, the lead author of a new study that looked at health records of 17 million privately insured Americans with obesity. It found that between 2022 and 2023, as prescriptions for GLP-1 drugs more than doubled, rates of bariatric surgery fell by 25.6%.
    • “The findings, published Wednesday in JAMA Network Open, mark a sharp turnaround from trends over the last decade, and spell an uncertain future for hospitals and clinics that derive a significant portion of their revenues from such procedures.”

From the U.S. healthcare business front

  • Beckers Payer Issues relates,
    • “Centene reported $713 million in net income in the third quarter, per its earnings report published Oct. 25.
    • “Total revenues in the third quarter were $42 billion, up 10.5% year over year.
    • “Total net earnings in the third quarter were $713 million, up 52% since the same period last year.
    • “The company reaffirmed its year-end adjusted EPS guidance of greater than $6.80.
    • ‘The company’s medical loss ratio was 89.2% in the third quarter and 87% during the same period last year.”
  • Per Healthcare Dive,
    • “Medicaid payment rates have yet to catch up with rising costs in the safety-net insurance program. However, conservative planning — along with business growth — yielded a surprisingly positive third quarter for health insurer Molina, according to analysts.
    • “Molina beat Wall Street expectations for earnings and revenue with a topline of $10.3 billion in the quarter, up 21% year over year, thanks in part to higher premiums. Profit of $326 million was up 33% year over year.
    • “Molina appears to be “beating the odds again” in Medicaid, Jefferies analyst David Windley said in a note on the payer’s results.”
  • Beckers Hospital Review points out that “Nashville, Tenn.-based HCA Healthcare posted an operating income of $1.9 billion (10.9% operating margin) in the third quarter of 2024, up from an operating income of $1.6 billion (10.1% margin) over the same period last year, according to its Oct. 25 financial report.”
  • Per MedTech Dive,
    • “Baxter plans to restart its highest throughput manufacturing line for IV solutions within the next week, “barring any unanticipated developments,” the company said on Thursday.
    • “Baxter is working to restore production at a North Carolina plant that makes about 60% of the U.S. supply of IV fluids, and is an important supplier of peritoneal dialysis solutions, according to the American Hospital Association.
    • “The company still has not shared a timeline for restoring full production at the facility after it was flooded by Hurricane Helene in early October. Baxter’s goal is to begin resuming production in phases by the end of the year.”
  • The Washington Post offers an interview with JC Scott, president and CEO of the Pharmaceutical Care Management Association (PCMA), the PBM trade association.
  • Beckers Payers Issues shares executive opinions on “opportunities payers can seize next year.”
  • Per Healthcare Dive,
    • “Cost management company MultiPlan is facing yet another lawsuit for allegedly conspiring to underpay providers — this time, from the largest physician association in the United States.
    • “The American Medical Association’s complaint, filed Thursday in an Illinois district court, accuses MultiPlan of colluding with major health insurers to set artificially low reimbursement rates for out-of-network care, forcing providers to accept payments that often don’t cover their operating costs.
    • “The litigation, which asks the judge for an injunction requiring MultiPlan to halt the illegal practices, is the latest in a long string of suits against the company. Congress is also scrutinizing MultiPlan, which denies the allegations.”