Midweek Update

Uncategorized

Midweek Update

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

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.”

Thursday Miscellany

David Ermer–Uncategorized–

From Washington, DC

  • OPM’s supplemental Postal Service Health Benefits Program final rule was published in the Federal Register today.
  • The FEHBlog is disappointed that OPM is pursuing a modified version of its Part D opt out penalty when 2025 Medicare Part D benefits are so obviously generous. Everyone should put more effort into promoting the advantages of 2025 Part D benefits, e.g., $2000 out of pocket maximum.
  • The FEHBlog also is disappointed that OPM is declining to share Medicare coordination of benefits information, such as Medicare beneficiary identifiers, with FEHB and PSHB carriers when for 35 years the FEHB Act has required OPM in combination with HHS to provide carriers with a Medicare coordination of benefits database. 5 U.S.C. Sec. 8910(d).
  • Govexec encourages federal employees to consider enrolling in a high deductible FEHB plan for 2025 so that they can enjoy the triple tax-free benefits of a health savings account.
  • Reg Jones writing in FedWeek discusses vesting in the federal retirement system.
  • Per an HHS press release,
    • Today, HHS Secretary Xavier Becerra released the following statement in response to new fluid supply increases from Baxter, Inc.:
    • “I am encouraged by reports that Baxter anticipates restarting the highest throughput manufacturing line at Baxter’s North Cove facility next week – sooner than originally expected. There’s more to do, including meeting regulatory requirements of the product manufactured on the restarted line, but this is good news for partners and patients. This progress is the result of a strong public-private partnership. We have quickly facilitated the import of product from six facilities around the world. We have made it easier for hospitals to produce their own IV fluid during the shortage. And HHS will continue to use all necessary authorities to bolster supply and mitigate impact to patients. I want to thank everyone for their continued work on this important part of the recovery process.”

From the public health and medical research front,

  • A “USDA/HHS Fact Sheet [explains the new actions that the] Biden-Harris Administration [is taking] * * * to Halt the Spread of Bird Flu, including in California and Washington.
  • The New York Times adds,
    • “A Missouri resident who shared a home with a patient hospitalized with bird flu in August was also infected with the virus, federal officials reported on Thursday.
    • “But symptomatic health care workers who cared for the hospitalized patient were not infected, testing showed. The news eased worries among researchers that the virus, H5N1, had gained the ability to spread more efficiently among people.
    • “Still, the number of human cases is rising in the United States. California said this week that it had confirmed 15 human cases of bird flu. Washington State has reported two poultry workers who are infected and five others presumed to be positive.
    • “There are 31 confirmed cases in the country, but experts have said the figure is likely to be an undercount. “Additional cases may be found as investigations continue,” Dr. Nirav Shah, the principal deputy director of the Centers for Disease Control and Prevention, said at a news briefing on Thursday.”
  • The AP reports,
    • “A California-based produce company was the source of fresh onions linked to a deadly E. coli food poisoning outbreak at McDonald’s, officials with the restaurant chain said Thursday. Meanwhile, other fast-food restaurants — including Taco Bell, Pizza Hut, KFC and Burger King — pulled onions from some menus.
    • “McDonald’s officials said that Taylor Farms, of Salinas, California, sent onions to one distribution facility, which led the fast-food chain to remove Quarter Pounder hamburgers from restaurants in several states. McDonald’s didn’t say which facility it was.
    • “An outbreak tied to the burgers has sickened at least 49 people in 10 states, including a person who died, federal health officials have said. Investigators said they were focused on slivered onions as a potential source of the infections.” * * *
    • “Officials with the U.S. Food and Drug Administration did not confirm that the agency is investigating Taylor Farms. A spokesperson said Thursday that the agency is “looking at all sources” of the outbreak.”
  • ABC News tells us,
    • “Thousands of bottles of a popular antidepressant medication are being recalled due to the presence of what the National Library of Medicine describes as a toxic chemical, according to a notice from the U.S. Food and Drug Administration.
    • “The recall involves the medication duloxetine, which is sold under the brand name Cymbalta, according to the FDA’s notice of the voluntary recall, which began Oct. 10.
    • “Duloxetine is part of a class of drugs known as SNRIs, or selective serotonin/norepinephrine reuptake inhibitors, that are used to treat anxiety, depression and other mood disorders, according to the FDA.”
  • NIH Director, Dr. Monica Bertagnolli, writes in her blog,
    • “You’ve surely seen fruit flies in your kitchen, perhaps hovering around a bowl of citrus fruits or over a glass of wine. While these insects might not seem especially brainy, typical fruit fly behaviors depend on a complex brain that’s wired to solve many of the same problems human brains do. Their nervous systems and brains must pick up on tempting scents and send the right signals through their bodies to move from one place to another to find food. Fruit flies form long-term memories, engage in social interactions with other fruit flies, and navigate over long distances. Though smaller than a poppy seed, the fruit fly brain is packed with hundreds of thousands of neurons and millions of neural connections all wired precisely to make those behavioral feats possible.
    • “Now, a scientific team supported by the NIH Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®, has unveiled the first complete map, or connectome, of every neural connection within the brain of an adult female fruit fly. This important milestone in brain science, reported in nine papers in Nature, details more than 50 million connections between nearly 140,000 neurons. As the first complete map of a connectome of any adult animal, it offers critical information about how complex brains are wired to send and receive signals underlying normal brain functions.” * * *
    • “While there’s still a lot to learn about how the human brain is wired and how it works, the fruit fly connectome serves as an important step toward developing the tools and capabilities required for mapping larger-brained animals and, eventually, the human brain, with its more than 80 billion neurons and 100 trillion connections. The connectome and the many exciting discoveries and developments yet to come will be critical for bringing much needed advances in understanding and one day treating a wide range of human brain disorders, including Alzheimer’s disease, Parkinson’s disease, severe depression, and addiction.”

From the U.S. healthcare business front,

  • Beckers Hospital Review shares information on Health Grade awards for hospital special care.
  • The American Journal of Managed Care informs us,
    • “Value-based care prioritizes patient outcomes and cost reduction, requiring alignment of reimbursement models and financial sustainability management.
    • “Private insurers are reforming payment models, but aligning specialty care with value-based goals remains challenging.
    • “Financial pressures and data integration are key hurdles in transitioning to value-based care, necessitating innovative partnerships.
    • “Educating patients about value-based care options is essential to reduce unnecessary emergency department visits and improve care outcomes.”
  • and
    • “Social determinants of health significantly influence health care costs across Medicare, Medicaid, and private insurance programs.
    • “Educational attainment and social isolation notably affect Medicaid expenditures, with higher costs linked to lower education and increased isolation.
    • “Neighborhood quality and economic stability are key factors in Medicare spending, impacting costs based on access to parks and financial confidence.
    • “Medical discrimination and debt collection contact are associated with increased private insurance expenditures.
    • “Integrating SDOH into policy could help manage healthcare costs and promote health equity, though challenges persist in implementation.”
  • Ken Kaufmann from Kaufmann Hall opines that “Changing American Demographics Make Hospital Operations Harder,” and he offers some ideas to help hospitals out.

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, Telehealth, U.S. Healthcare, Uncategorized–

From Washington, DC

  • An HHS fact sheet lets us know,
    • ‘Following storm damage from Hurricane Helene at Baxter International Inc.’s facility in North Carolina, the U.S. Department of Health and Human Services (HHS) and its subagencies continue taking action to support access to intravenous (IV) fluids, including ensuring restoration of key production sites, protecting products, and opening imports, in partnership with manufacturers, distributors, hospitals, and other stakeholders. As a result of these steps, hospitals have 50% more product available to them now compared to right after the hurricane. Baxter has moved and begun distributing more than 450 truckloads of product from their North Carolina facility over the past 10 days and is already importing additional product from their foreign plants. FDA acted quickly to conduct scientific and regulatory assessments to help facilitate the temporary importation of 23 different IV and peritoneal (PD) fluids from five Baxter facilities around the world. Baxter communicated that supply availability is continually improving, and they expect to further increase customer allocations to 90%-100% of historical levels for many IV solution product codes no later than the end of the year. These supply improvements, combined with increased output from other manufacturers, will help hospitals get more of the product they need over the coming weeks.
    • ‘HHS, Food and Drug Administration (FDA), the Administration for Strategic Preparedness and Response (ASPR), and the Centers for Disease Control and Prevention (CDC) continue to use all available authorities to protect patients, support supply, and keep stakeholders informed, in partnership with manufacturers, distributors, hospitals, and other stakeholders. Additionally, HHS is announcing additional information about the airlift of Baxter products into the U.S. from international facilities, with first flights scheduled for October 19.‘
  • The New York Times reports,
    • “The Veterans Affairs Department is investigating whether Acadia Healthcare, one of the country’s largest chains of psychiatric hospitals, is defrauding government health insurance programs by holding patients longer than is medically necessary, according to three people with knowledge of the inquiry.
    • “The investigation, led by the agency’s inspector general, comes three weeks after Acadia told investors that it was facing scrutiny for its admissions practices from several other federal investigators, including prosecutors in Manhattan and a grand jury in Missouri. The company, which relies on government insurance programs like Medicare and Medicaid for much of its revenue, said it was also expecting to receive inquiries from the Securities and Exchange Commission and other agencies.
    • “Acadia told investors that it was “fully cooperating with authorities and, at this time, cannot speculate on whether the outcome of these investigations will have any impact on its business or operations.” The company has denied claims that it was improperly holding patients and has said that all decisions about care are made by licensed medical professionals.”
  • STAT News informs us,
    • “Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $63 billion in 2023, a 23.4% increase from the previous year, according to the Health Resources & Services Administration, which oversees the program.
    • “The data mark a steady rise in sales under the 340B Drug Discount Program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% — but could be higher — off all outpatient drugs to hospitals and clinics that primarily serve lower-income patients. There are more than 12,000 entities participating in the program, a number that has grown substantially.
    • “Since it began more than 30 years ago, the program has ballooned and fed into the national clash over the cost of medicines. Some $38 billion in prescription medications were purchased under the 340B program in 2020, for instance, which was up from $16.2 billion in 2016. And this fast-paced trajectory has triggered a battle between the pharmaceutical and hospital industries.”

From the public health and medical research front

  • The Center for Disease Control and Prevention announced,
    • “COVID-19 activity is declining in all 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 all areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels.
      • “The XEC variant is estimated to comprise 7-16% among circulating viruses as of October 12, 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,
    • “CDC wastewater tracking shows that [COVID] viral levels remain low, with levels currently highest in the northeast. The latest data from WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, show that detections are in the medium category nationally, with a downward trend over the last 3 weeks. It said the South and West are currently at the low level.”
  • The AP tells us,
    • “Teen smoking hit an all-time low in the U.S. this year, part of a big drop in the youth use of tobacco overall, the government reported Thursday.
    • “There was a 20% drop in the estimated number of middle and high school students who recently used at least one tobacco product, including cigarettes, electronic cigarettes, nicotine pouches and hookahs. The number went from 2.8 million last year to 2.25 million this year — the lowest since the Centers for Disease Control and Prevention’s key survey began in 1999.
    • “Reaching a 25-year low for youth tobacco product use is an extraordinary milestone for public health,” said Deirdre Lawrence Kittner, director of CDC’s Office on Smoking and Health, in a statement. However, “our mission is far from complete.”
    • “A previously reported drop in vaping largely explains the overall decline in tobacco use from 10% to about 8% of students, health officials said.”
  • The UMN CIDRAP mentions,
    • “Including preset treatment orders in the electronic medical records of children with ear infections dramatically improved compliance with antibiotic treatment guidelines, researchers reported at IDWeek 2024.
    • “In a study conducted at the University of Colorado/Children’s Hospital Colorado, researchers analyzed data on 34,324 children aged 61 days to 18 months who visited emergency and urgent care centers in the health system for acute otitis media (AOM) from January 2019 to September 2023. Their aim was to assess the effectiveness of a bundled intervention for AOM that included an electronic health record (EHR) order set (implemented in April 2021) that pre-selected a 5-day antibiotic course for children 24 months and older and a local clinical care pathway (implemented in December 2022) that encouraged observation and pain management for children with non-severe AOM. 
    • “Presenting author Joana Dimo, DO, a doctoral fellow at the University of Colorado, said the bundle was developed to address a common problem in antibiotic prescribing for AOM: while most cases (up to 75%) resolve without antibiotics, most children receive antibiotics, often for longer than needed.
    • “We noticed at our institution that children were being prescribed a lot of antibiotics for ear infections, and that the duration of antibiotics was longer than we thought necessary,” Dimo said at a press briefing.”
  • Per Fierce Pharma,
    • “After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy.
    • “The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up as a first-line treatment for adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.
    • “With the green light, Vyloy becomes the first U.S.-approved anti-CLDN18.2 drug. The transmembrane protein, also known as Claudin-18.2, has become a red-hot target in the oncology field, ginning up interest from the likes of AstraZeneca, Leap Therapeutics, Legend, Moderna and other companies.
    • ‘Friday’s approval specifically covers Vyloy in combination with fluoropyrimidine- and platinum-containing chemotherapy. Patients must have the CLDN18.2 positivity of their tumors confirmed through testing, and, to that end, the FDA has simultaneously approved a new companion diagnostic from Ventana Medical Systems and Roche.”
  • Per BioPharma Dive,
    • “An experimental antibody drug developed by Merck & Co. significantly reduced the incidence of disease due to respiratory syncytial virus infections as well as related hospitalizations in infants, the company said Thursday.
    • “Called clesrovimab, the antibody met all the goals of a Phase 2b/3 study testing it in more than 3,600 healthy pre- and full-term infants. A dose of clesrovimab lowered RSV disease incidence by 60%, and RSV-associated hospitalizations by 84%, compared to placebo through five months post-treatment.
    • “While three RSV vaccines are approved in the U.S. for older adults, only one antibody drug — Sanofi and AstraZeneca’s Beyfortus — is cleared for all infants entering their first RSV season. If approved, clesrovimab would compete with Beyfortus.”
  • and
    • “Gilead will no longer sell its combination drug Trodelvy to treat bladder cancer, announcing Friday it had agreed with the Food and Drug Administration to withdraw it following negative trial results.
    • “The FDA granted Trodelvy accelerated approval for bladder cancer in 2021, based on results that found it shrank tumors in people whose disease had progressed following treatment with chemotherapy and immunotherapies like Merck & Co.’s Keytruda. But a confirmatory study, titled TROPiCS-04, failed to show the medicine helped people live longer.
    • “Trodelvy’s withdrawal is one of several conditional approvals that have been rescinded in recent years, most notably among the “PD-1” class of drugs that includes Keytruda and Bristol Myers Squibb’s Opdivo. The Trodelvy decision, however, came months after negative trial results, a sign the FDA has become more vigilant about resolving so-called “dangling” accelerated approvals.’

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “CVS Health replaced CEO Karen Lynch on Thursday as the healthcare and pharmacy giant’s financial challenges mount.
    • “CVS’ new chief executive is David Joyner, a company veteran who most recently headed up CVS’ pharmacy benefit manager Caremark. Lynch, who held the top spot at CVS since 2021 and previously led insurer Aetna, stepped down “in agreement with the company’s Board of Directors,” according to a release. 
    • “The company also pulled earnings guidance provided last quarter due to higher medical costs in its Aetna health benefits segment. CVS’ stock fell more than 7% in early morning trade Friday following the news.”
  • The Wall Street Journal adds,
    • “Roger Farah, chairman of CVS’s board of directors, will also become executive chair.” * * *
    • “Joyner and Farah said in an interview with the Journal that CVS will now move forward intact. 
    • “We believe that we have a really important part to play in terms of simplifying and delivering a better healthcare experience for this country,” Joyner said. CVS’s assembled assets will allow it “to actually deliver on the promises that we’ve made, and now it’s all about execution.” * * *
    • “CVS will also report that medical costs are still running higher than expected, an issue that has come up in other insurers’ recent reports. Aetna’s medical loss ratio, or the share of premiums spent on healthcare costs, will be around 95.2%, compared with analysts’ expected 91.1%.”
  • Modern Healthcare reports,
    • “Cigna Group has revived efforts to combine with its smaller rival Humana Inc. after merger talks fell apart late last year, according to people familiar with the matter. 
    • “The two health insurance giants have held informal discussions recently about a potential deal, said the people who asked to not be identified because the talks aren’t public. The discussions are in early stages, they added.
    • Cigna is looking to close the sale of its Medicare Advantage business in the coming weeks before committing to any other transactions, one of the people said.
  • Beckers Hospital Review lets us know,
    • “Shifting care from in-person to virtual settings could reduce total medical claims spending by 2.3% to 3.1%, according to an Oct. 17 study from Solera Health.
    • “The research analyzed longitudinal medical claims data from 50 million commercially insured U.S. adults. The study first identified patients eligible for virtual care based on an outpatient visit for a qualifying diagnosis over a six-month period. Researchers then reviewed the previous 12 months of claims to assess whether patients’ conditions were uncomplicated or complex, followed by a 12-month forward analysis to evaluate whether their conditions remained controlled or became uncontrolled after their initial in-person visit. 
    • “According to estimates from CMS on private insurer spending in 2022, this shift to virtual care could result in cost savings of over $50 billion each year.”
  • Per Fierce Healthcare,
    • “Cancer continues to be employers’ biggest treatment cost, driving up healthcare spending. 
    • “Costs for cancer-related medical services and drugs are expected to reach nearly $250 billion in the U.S. by 2030—a 34% increase since 2015, according to a study by the American Association for Cancer Research.
    • “And, while oncology accounts for only 1% of claims volumes, it makes up 15% of the overall employer healthcare spend, according to a report by The Mahoney Group.
    • “Health tech company Color Health is doubling down on its play for employer-sponsored cancer care, building on its work with the American Cancer Society (ACS) to offer comprehensive cancer management.
    • The company developed a fully integrated virtual cancer clinic for employers, unions and health plans that is designed to support individuals from screening and early detection through diagnosis, treatment and survivorship.
    • “Color, a platform for large-scale care delivery, is rolling out its virtual cancer clinic to more than 45 employers, health plans and unions across the country. The offering will be made available to customers starting January 2025.”

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
  • Govexec observes “The Office of Personnel Management’s inspector general last month reported that the federal government’s dedicated HR agency faces taller tasks in the form of launching a health insurance program for postal workers and verifying enrollees’ eligibility for the Federal Employees Health Benefits Program.”
  • While Govexec accurately reflects the substance of the OIG’s report, the FEHBlog disagrees with the OIG conclusions for the following reasons —
    • The OIG and GAO focus on family member eligibility issues. FEHB carriers, or their underwriters, hold the FEHB Program’s insurance risk. The biggest eligibility issue is that OPM does not use the HIPAA 820 enrollment roster transaction which would allow carriers to electronically reconcile individual enrollees with the premiums. This remains a yawning internal gap for the FEHBP.
    • OPM intelligently is assigning Postal employees and annuitants to their appropriate PSHB plan this month. OPM is electronically notifying carriers about these enrollments and OPM is mailing notices to these folks about their enrollments which can be changed during Open Season. If OPM’s new enrollment system breaks down (see healthcare.gov in 2013), the FEHBlog is certain that OPM has a Plan B for making PSHB enrollment change. In the FEHBlog’s view, OPM’s plan provides a high likelihood that the PSHB will timely launch on January 1, 2025.
  • Sequoia reminds us,
    • “The Centers for Medicare and Medicaid Services (CMS) issued Final Rules on how and when civil monetary penalties may be imposed when Responsible Reporting Entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting obligations.
    • “Under MSP rules, group health plans are required to submit certain information to CMS on plan participants that are dual enrolled in the group health plan and Medicare. By doing so, CMS can better identify when another party should pay primary, thereby avoiding unnecessary claims payment mistakes.
    • “Generally, a group health plan RRE is the insurer for fully insured plans and the third-party administrator (TPA) for self-funded plans. Employers are not likely to be an RRE, or otherwise have direct reporting obligations, unless as plan administrator they both self-fund and self-administer the plan. However, employers will need to provide any required information requested by the RRE (i.e., insurer or TPA) for them to accurately submit the reporting on the employer’s group health plan to CMS.
    • “Penalties against an RRE are up to $1,000 (as adjusted) per instance of noncompliance for each calendar day that a record is late, with a maximum annual penalty of $365,000 per instance. Penalties may be waived if RREs can show “good faith efforts” to report any records identified by CMS as being noncompliant. Also, CMS will apply a five-year statute of limitations on assessing civil monetary penalties for violations of mandatory reporting requirements.”
    • Important Dates
      • December 11, 2023: Effective date for the Final Rules.
      • October 11, 2024 / TODAY: Earliest date the provisions of the Final Rules will be applied.
      • October 11, 2025: Start date for compliance review and penalty enforcement.
      • April 1, 2026: CMS begins quarterly compliance audit; reviewing a random sample of 250 new records per quarter for a total of 1,000 records per year.
  • Bloomberg lets us know,
    • “Medicare patients changed to outpatient “observation status” after they were initially hospitalized now have a chance to appeal their reclassification under a rule finalized by the Biden administration on Friday. 
    • “The rule (RIN 0938-AV16) would implement a 2020 ruling by the US District Court for the District of Connecticut in a class action involving a dispute over Medicare’s obligation to pay for hospitalizations and long-term care for elderly patients.”
  • The Wall Street Journal reports,
    • “Teva Pharmaceuticals will pay $450 million to resolve allegations that the generic drug manufacturer submitted false claims and violated a federal law that prohibits the payment of kickbacks to generate federal healthcare business or induce patient referrals.
    • “The Justice Department on Thursday said the settlement amount was based on the company’s, whose U.S. headquarters is in Parsippany, N.J., ability to pay. As part of the settlement, there was no admission of wrongdoing on Teva’s part.
    • ‘Teva said it is pleased to put these matters in the past in order to focus on developing and providing access to medicines for patients who need them.”
  • The American Hospital Association News points out,
    • A survey released Oct. 9 and funded by the American Foundation for Suicide Prevention, the Suicide Prevention Resource Center and the National Action Alliance for Suicide Prevention, a public-private partnership whose members include the AHA, shows 63% of U.S. adults are aware of the 988 Suicide and Crisis Lifeline, a 6% increase from 2022. The survey also found that 71% of adults feel comfortable contacting a mental health hotline, while 15% said they have used one previously. Among other findings, 91% of U.S. adults perceive mental health as equal to or more important than physical health, but 49% feel that physical health is treated as more important.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19 activity is declining in most areas. Seasonal influenza is low nationally. Signs of increased RSV activity have been detected in the southeastern United States, including Florida, particularly 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.
      • “The new XEC variant is estimated to comprise 7-16% among circulating viruses as of October 12, 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 southeastern United States, including Florida, particularly in young children.
    • “Vaccination
      • “Vaccinations to prevent fall respiratory viruses have started for the 2024-25 fall and winter virus season. RSV, influenza, and COVID-19 vaccines are available to provide protection.
  • The University of Minnesota’s CIDRAP tells us,
    • “The California Department of Public Health (CDPH) reported today that the US Centers for Disease Control and Prevention (CDC) has confirmed two of its latest probable H5 avian flu cases, as it reported another likely case based on state testing, which if confirmed would raise the state’s total to seven.
    • “California’s flurry of human cases is occurring amid an ongoing surge of outbreaks affecting the state’s dairy farms, which are concentrated in the Central Valley. Also today, the CDC shared the latest findings from genetic sequencing, which so far show no worrying changes.”
  • and
    • “Genetic sequencing has identified a second cluster of tecovirimat-resistant mpox infections in the United States—the first of its kind involving interstate spread. Researchers from the US Centers for Disease Control and Prevention (CDC) and partners from five affected states reported their findings yesterday in Morbidity and Mortality Weekly Report.
    • “The first Tpoxx-resistant cluster was identified in California in late 2022 and early 2023 in people who hadn’t previously been treated with the drug. The new report describes a new unrelated cluster among 18 people with no previous treatment across multiple states. * * *
    • “In vitro testing of seven samples showed resistance to Tpoxx. Whole-genome sequencing showed that the resistance mutations came from a common ancestor but were distinct from the earlier California cluster.
    • “Researchers said because not all viruses from mpox cases are sequenced, the findings likely underestimate the prevalence of the newly identified drug-resistant variant. They added that more surveillance is needed, as well as adherence to CDC Tpoxx use protocols. Also, they wrote that the findings underscore the need for more treatments for mpox, along with smallpox biothreat preparedness.”
  • Reuters reports,
    • “Roughly 15.5 million U.S. adults have attention-deficit hyperactivity disorder, and most of them struggle with gaining access to treatment for the condition, according to data from a U.S. study released on Thursday.
    • “Only about one-third of those reporting a diagnosis of ADHD said they had received a prescription for a stimulant drug used to treat it in the previous year, researchers reported in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
    • “In addition, nearly three quarters of those with a prescription for a stimulant drug reported difficulty getting it filled because the medication was unavailable.
    • “Worldwide, around 2% to 5% of adults experience ADHD symptoms such as inattention, hyperactivity, and impulsivity. This study provides the first prevalence data on ADHD in U.S. adults since 2003.”
  • The Wall Street Journal informs us,
    • “The Food and Drug Administration approved Pfizer’s Hympavzi to prevent or reduce bleeding episodes in patients with certain kinds of hemophilia, the pharmaceutical company said.
    • “The approval is for patients with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX inhibitors, Pfizer said Friday.
    • “Hympavzi, also known as marstacimab, can be given subcutaneously every week for routine prophylaxis in patients aged 12 and up as an alternative to intravenous infusions that are often administered multiple times a week, Pfizer said.
    • “The FDA said the drug is the first non-factor and once-weekly treatment for hemophilia B. The agency said the approval provides “a new treatment option that is the first of its kind to work by targeting a protein in the blood clotting process.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Thursday approved a new Roche drug for breast cancer. Called Itovebi, the drug has been cleared for use with Pfizer’s Ibrance and endocrine therapy in people whose HR-positive, HER2-negative breast tumors have a mutation called PIK3CA.
    • It’ll compete for market share with Novartis’ Piqray, another medicine targeting PIK3CA mutations. Itovebi is one of five drugs Roche aims to add to its portfolio of breast cancer treatments, which already includes the targeted therapies Herceptin, Perjeta and Kadcyla. 
  • Per Health Day,
    • “It’s never too late for a person to quit smoking, even if they’re elderly, a new study finds.
    • “Dropping the smokes even as late as 75 can meaningfully increase a person’s life expectancy, researchers reported recently in the American Journal of Preventive Medicine.
    • “Seniors aged 75 will lose on average more than four years of life if they keep smoking, compared to people who never smoked, researchers found.
    • “On the other hand, a 75-year-old smoker who quits has a 14% chance of gaining at least one extra year of life, and a 65-year-old smoker a 23% chance.
    • “And about 8% of those who quit at age 75 gain at least four years of life compared to those who keep smoking, researchers found.
    • “Quitting smoking is the single best thing anyone at any age can do to increase their life expectancy, researchers concluded.”

From the U.S. healthcare business front,

  • MedTech Dive relates,
    • “Fresenius Medical Care said Thursday it will increase its production of IV fluid and peritoneal dialysis (PD) products as the U.S. manages shortages due to Hurricane Helene’s effect on the supply chain.
    • “The company is maximizing production capacity at its international sites to help add supply amid an industrywide supply shortage of PD products and IV fluids, according to the update. Fresenius Medical Care is also exploring other options to address the shortage at the Department of Health and Human Services’ request.”
  • Beckers Payer Issues offer new payer game plans for improving women’s health.
  • Fierce Healthcare provides details on the latest Medicare Advantage star scores.
  • Modern Healthcare notes,
    • “Mary Beth Jenkins will become the president and CEO of University of Pittsburgh Medical Center Health Plan starting Jan. 1. 
    • “Jenkins was also named president of UPMC Insurance Services Division and an executive vice president of the system. She will succeed Diane Holder, who plans to retire Dec. 31 after 40 years with UPMC.
    • “Jenkins has been executive vice president of UPMC Insurance Services Division and chief operating officer of UPMC Health Plan since 2023. She joined Pittsburgh-based UPMC in 1998.” 
  • Optum offers HSA plans tips on personalized member communications strategies.

Thursday Miscellany

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “Eli Lilly has finally made enough supply of its popular medicine tirzepatide to meet soaring demand, which should help the company widen its share of the booming weight-loss drug market.
    • “The Food and Drug Administration said late Wednesday that Lilly had resolved the shortage. It had started in 2022, just months after the drug was introduced with the brand Mounjaro for diabetes. Tirzepatide was approved as Zepbound in late 2023 as a weight-loss treatment.
    • ‘The milestone means that compounding pharmacies that make knockoff versions of tirzepatide will likely face new restrictions on what they can produce.
    • “The compounding pharmacies had legal cover to sell knockoff tirzepatide as long as it was on the FDA shortage list, and many patients turned to these products as a cheaper alternative. Yet in announcing the end of the shortage, the FDA said federal law bars compounders from making copies of drugs that aren’t on the shortage list, though they may make certain amounts.
    • “This essentially precludes compounded tirzepatide from being produced commercially,” BMO Capital Markets analysts said.” * * *
    • “Lilly’s rival, Novo Nordisk, also has been expanding its production capacity to resolve shortages of a similar drug, semaglutide, sold as Ozempic for diabetes and Wegovy for weight loss. The lowest dose of Wegovy is currently in shortage, while higher Wegovy doses and all Ozempic doses are available, according to the FDA shortage list.”

  • Per Healthcare Dive,
    • “A bipartisan group of two dozen lawmakers is urging the Biden administration to extend telehealth prescribing flexibilities for opioid use disorder treatment. 
    • “The representatives, led by Reps. Annie Kuster, D-N.H., and Carol Miller, R-W.Va., argued flexibilities allowing telehealth prescriptions of buprenorphine without an in-person visit has increased access to treatment and reduced overdoses.
    • “But those flexibilities are set to expire at the end of the year. Lawmakers also raised concerns that the Drug Enforcement Administration could propose more stringent requirements for telehealth prescriptions of buprenorphine, a medication that be used to treat opioid use disorder, limiting its use just as overdose deaths have begun to decline.” 
  • STAT News reports,
    • “A key aspect of the Democrat-passed law to lower drug prices is significantly more expensive to the government than expected, according to nonpartisan budget experts in Congress.
    • “The redesign of the Medicare Part D drug benefit will cost $10 billion to $20 billion more next year than the Congressional Budget Office initially projected. That office estimates that a separate recently announced program to pay insurers to lower drug premiums will cost $5 billion.”
  • Per Fierce Healthcare,
    • The Biden administration could stand to take a firmer hand on hospital price transparency, especially when it is unclear whether the price data being published are even accurate, the Government Accountability Office (GAO) wrote in a Wednesday report.
      The Centers for Medicare & Medicaid Services (CMS) has required hospitals to post the prices for numerous services annually and this past summer raised the bar by ensuring hospitals were doing so using a standardized file format.
    • Numerous reports from stakeholders criticized hospitals’ compliance along the way, with hospitals themselves often saying that the requirements were burdensome and often too vague.
    • On instruction from Congress, the GAO conducted a review of the requirements, the CMS’ enforcement and whether the agency’s policy was successfully serving patients, payers and researchers.
    • The GAO interviewed 16 stakeholder groups—representing those three groups—who described difficulties making effective comparisons and compiling the data for large-scale use. These hurdles were tied to inconsistent file formats, pricing complexities that came across poorly in the machine-readable format and what they perceived to be incomplete and inaccurate data sets.
    • “While the use of hospital price transparency data has been limited so far, many stakeholders we interviewed noted that they expect use to increase over time if the data usability challenges are overcome or addressed,” the GAO wrote in the report. “Further, some stakeholders also noted that it will take health plans and employers time to figure out how to effectively use the pricing data as part of their price negotiations and their efforts to develop networks of health care providers.”
  • The GAO also issued a healthcare capsule report on treatment for drug misuse.
  • Per an HHS press release,
    • “As part of the Biden-Harris administration’s efforts to ensure Americans access to affordable medicines and strengthen American medical supply chains, the Administration for Strategic Preparedness and Response (ASPR) today announced a $12.3 million agreement with California-based Amyris to expand U.S.-based manufacturing of key starting materials and active pharmaceutical ingredients needed to make essential medicines.” 
  • Tammy Flanagan, writing in Govexec, discusses end of year retirement planning for federal couples.
  • Per an OPM press release,
    • “The U.S. Office of Personnel Management (OPM) has authorized the use of an emergency leave transfer program (ELTP) for federal employees and their families adversely impacted by Tropical Cyclone, Tropical Storm, and Hurricane Helene.    
    • “After coordinating with federal agencies to assess the impact on employees by Tropical Cyclone, Tropical Storm, and Hurricane Helene and its aftermath, OPM, in consultation with the Office of Management and Budget (OMB), has determined that the establishment of an ELTP is warranted. The establishment of an ELTP permits employees in the executive and judicial branches, or agency leave banks established under 5 U.S.C. 6363 to donate unused leave for transfer to employees within their agency or at other agencies who are severely adversely affected or have family members who are severely adversely affected by a major disaster or emergency as declared by the President and who need additional time off from work without having to use their own paid leave. This ELTP will assist federal employees in the declared disaster areas in Alabama, Florida, Georgia, North Carolina, South Carolina, Tennessee, and Virginia. Furthermore, if President Biden approves other disaster declarations because of Helene, federal employees in those areas will also become eligible for ELTP donations.”    
  • Federal News Network tells us,
    • “The Merit Systems Protection Board has brought a historic backlog of federal employee adverse action cases down to nearly zero.
    • “By the end of September, MSPB reported that it had issued decisions on 94% of the thousands of federal employee appeal cases that had been sitting stagnant during the record five-year period without a quorum. Between 2017 and 2022, vacant board seats left the agency unable to issue case decisions, and thousands of federal employees without answers on their pending appeals.
    • “As an agency, MSPB aims to protect federal employees against prohibited personnel practices, like whistleblower retaliation, by adjudicating adverse action appeals from employees. But during more than five years without a quorum — which requires at least two of the three board seats to be occupied — MSPB amassed nearly 3,800 pending cases from federal employees looking to appeal a decision on an adverse action.
    • “The process of shrinking the significant case backlog has so far taken about 2.5 years for the current MSPB members. During fiscal 2025, the board expects to fully eliminate the remaining pending cases that built up during the lack of quorum. The agency will likely take the “inherited inventory” down to zero by the end of December, according to an MSPB spokesperson.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The U.S.’s largest maker of intravenous fluids will slash shipments to hospitals after Hurricane Helene took down one of its manufacturing plants in North Carolina. 
    • “Baxter sent letters to hospitals telling them that future shipments of IV fluids would be about 40% of what they normally receive after the storm flooded its facility in Marion, N.C., Dr. Paul Biddinger, chief preparedness and continuity officer at Mass General Brigham in Boston said during a conference call Thursday. 
    • “Mass General Brigham, a prestigious hospital system, said it is continuing to treat patients normally, but is conserving its fluid supplies. This includes switching to oral hydration—Gatorade or water—for patients who are healthy enough for it, and not discarding partially used IV fluid bags when patients are moved to a different part of the hospital, Biddinger said. The organization uses hundreds of thousands of liters of IV fluids each month, and a majority of patients admitted to a hospital receive fluids at some point, Biddinger said.
    • “Right now we’re continuing all of our clinical care as we normally do,” Biddinger said. “Our intent is to preserve clinical care in the face of this shortage as long as we possibly can.” 
  • Beckers Hospital Review identifies the 73 drugs and intravenous fluids made at the flooded Baxter facility.
  • The Washington Post explains “Why fears of human-to-human bird flu spread in Missouri are overblown. Hospital workers reported respiratory symptoms after encountering a Missouri patient with H5N1 who had not been exposed to farm animals. Officials say bird flu transmission is unlikely.”
  • The NIH Director, writing in her blog, tells us,
    • “In recent years, medical researchers have been looking for ways to use artificial intelligence (AI) technology for diagnosing cancer. So far, most AI models have been developed to perform specific tasks in cancer diagnosis, such as detecting cancer presence or predicting a tumor’s genetic profile in certain cancer types. But what if an AI system could be more flexible, like a large language model such as ChatGPT, performing a variety of diagnostic tasks across multiple cancer types?
    • “As reported in the journal Nature, researchers have developed an AI system that can perform a wide range of cancer evaluation tasks and outperforms current AI methods in tasks like cancer cell detection and tumor origin identification. It was tested on 19 cancer types, leading the researchers to refer to it as “ChatGPT-like” in its flexibility. According to the research team, whose work is supported in part by NIH, this is also the first AI model based on analyzing slide images to not only accurately predict if a cancer is likely to respond to treatment, but also to validate these predictions across multiple patient groups around the world.” * * *
    • “This is all good news, but there’s much more work ahead before an AI model like this could be used in the clinic. Next steps for the researchers include training the model on images of tissues from rare cancers, as well as from pre-cancerous and non-cancerous conditions. With continued development and validation, the researchers aim to enable the system to identify cancers most likely to benefit from targeted or experimental therapies in hopes of improving outcomes for more people with cancer in diverse clinical settings around the world.”
  • Healio informs us,
    • “The addition of HPV vaccination into routine postpartum care may increase vaccination rates, which can reduce patient costs, prevent HPV-related cancers and vaccinate vulnerable populations, researchers reported in Obstetrics & Gynecology. 
    • “The postpartum period has been identified as a missed opportunity for HPV vaccination counseling and administration,” Sara E. Brenner, MD, MPH, third-year resident in the department of gynecology and obstetrics at Emory University School of Medicine, and colleagues wrote. “Many vaccinations are already given routinely in the postpartum period such as the Tdap and the measles-mumps-rubella vaccines. These are often incorporated into perinatal workflows so that patients are routinely educated on their options for vaccination during their prenatal visits and postpartum patients can receive them before leaving the hospital.”
  • The American Hospital Association News informs us about “refreshed webpages dedicated to maternal and child health. The redesigned platform offers three distinct subpages focused on Better Health for Mothers and Babies, child and adolescent health, and advocacy and policy. Hospitals and health systems are encouraged to explore the tools and resources, such as case studies, podcasts, infographics and action plans to drive their own improvement in maternal and child health.”
  • Per STAT News,
    • “Apple Watch may help keep people with Parkinson’s disease out of the hospital. That’s according to early data from a Kaiser Permanente pilot program.
    • “Since late 2023, Kaiser Permanente has been giving some of its Parkinson’s patients in California an Apple Watch app called StrivePD, developed by Rune Labs. The app uses the onboard sensors in the device to track tremors associated with the disease; dyskinesia, a side effect of medication; activity; sleep; and falls. Using Rune’s software, people can also track medication intake and other data.” * * *
    • “Kaiser and Rune presented data from 138 patients enrolled in the program at the International Congress of Parkinson’s Disease and Movement Disorders in late September. In a limited run, the program reduced patient visits to the emergency department by 42% and reduced visits to movement disorder specialists by 18%. Three-quarters of people in the program reported that they found StrivePD helpful for staying on top of medications.
    • “It’s important to note that the data is only a snapshot from the first 100 days that people are in the program. It is not a randomized control that researchers would want to see to establish the benefits of a treatment program. And the data has not been published in a peer-reviewed publication.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports this evening,
    • “U.S. dockworkers agreed to return to work after port operators sweetened their contract offer, ending a three-day strike that threatened to disrupt the American economy.
    • “The breakthrough Thursday came after port employers offered a 62% increase in wages over six years, according to people familiar with the matter.
    • “The agreement ends a strike that had closed container ports from Maine to Texas and threatened to disrupt everything from the supply of bananas in supermarkets to the flow of cars through America’s factories.”
  • Per Fierce Healthcare,
    • “Another significant legal headache related to star ratings is on the table of the federal government just days before open enrollment begins.
    • “UnitedHealthcare companies in various states are suing the Centers for Medicare & Medicaid Services (CMS) for decreasing the insurer’s star ratings unfairly. They are looking for an injunction and corrected ratings before Oct. 15.
    • “The plaintiffs allege one metric, call center customer service performance, was downgraded based on an “arbitrary and capricious assessment” of one phone call [by a CMS test caller] that lasted eight minutes. It caused the insurer to earn a four-star rating on the call center measure instead of a five-star rating.”
    • UnitedHealthcare said the star ratings downgrade would “misinform millions of current and potential customers” from choosing their plans, the insurer said in the lawsuit.
  • Per BioPharma Dive,
    • “Eli Lilly on Wednesday announced plans to spend $4.5 billion on a new facility that will use advancements in technology for research and manufacturing.
    • “Dubbed the Lilly Medicine Foundry, the new site will be located in the “LEAP Research and Innovation District” in Lebanon, Indiana. The latest infusion of cash brings Lilly’s investment in the LEAP district to more than $13 billion.
    • “The facility will allow Lilly to produce medicines for clinical trials while also researching new methods of manufacturing, the company said. Technologies developed at the foundry can then be deployed at other production sites around the world.”

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Medical / Rx research, Medicare, Patient safety, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per a CMS press release,
    • “Today, the Centers for Medicare & Medicaid Services (CMS) announced that average premiums, benefits, and plan choices for Medicare Advantage (MA) and the Medicare Part D prescription drug program will remain stable in 2025. Average premiums are projected to decline in both the MA and Part D programs from 2024 to 2025. Enhancements adopted in the 2025 MA and Part D Final Rule, as well as payment policy updates in the 2025 MA and Part D Rate Announcement, support this stability and increase enrollee protections and access to care for people with Medicare. In addition, the Inflation Reduction Act is reducing prescription drug costs and delivering more comprehensive benefits than ever before, including an annual $2,000 cap on out-of-pocket drug costs. CMS is committed to ensuring these programs work for people with Medicare, that they have access to strong and stable choices, and that they have the information they need to make informed choices about what is best for them. 
    • “CMS is releasing this key information, including 2025 premiums, benefits, and access to plan options for MA and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, which runs from October 15, 2024, to December 7, 2024, to help people with Medicare determine the best Medicare coverage option for their health care needs. * * *
    • “For more information on MA and Medicare Part D offerings for 2025, view the fact sheet. 
    • “To view the premiums and costs of 2025 Medicare Advantage and Part D plans, please visit https://www.cms.gov/medicare/coverage/prescription-drug-coverage. Select the 2025 landscape source file in the downloads section of the webpage. This year, CMS has combined the Landscape files into one file, instead of five individual files as was the case historically, and made additional enhancements to improve the end-user experience and simplify the format. The accompanying readme file at the link above provides important notes about the format and file columns.    
    • “For state-by-state information, important dates, and enrollment resources for Medicare Advantage and Part D in 2025, please visit: https://www.cms.gov/files/document/2025-ma-part-d-landscape-state-state-fact-sheet.pdf.
    • “For information on the Medicare Advantage Value-Based Insurance Design Model, including plan participation in 2025, please visit: https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-value-based-insurance-design-model-calendar-year-2025-model-participation.” 
  • Beckers Payer Issues offers ten notes on the CMS press release.
  • The American Hospital Association News lets us know,
    • “The Health Resources and Services Administration Sept. 27 sent a final warning letter to Johnson & Johnson urging the company to inform the agency by Monday, Sept. 30 that it would halt its proposed 340B rebate model scheduled to go into effect next month. 
    • “As outlined in HRSA’s September 17, 2024, letter, if J&J proceeds with implementing its rebate proposal without Secretarial approval, it will violate section 340B(a)(1) of the Public Health Service Act,” HRSA wrote today. “If J&J has not notified HRSA that it is ceasing implementation of its rebate proposal by September 30, 2024, HRSA will begin the process outlined in J&J’s Pharmaceutical Pricing Agreement related to terminating the agreement. In addition, if J&J moves forward with implementation of its rebate proposal, HRSA will initiate a referral to the HHS Office of Inspector General pursuant to 42 U.S.C. § 256b(d)(1)(B)(vi).” 
  • Federal. News Network informs us,
    • “Postmaster General Louis DeJoy is telling lawmakers the Postal Service is ready to handle a high volume of mail-in ballots ahead of Election Day.
    • “DeJoy told members of the House Appropriations Committee on Thursday that USPS has a “track record of success” delivering ballots.
    • “In 2020, at the height of the COVID-19 pandemic, USPS delivered 99.89% of ballots from voters to election officials within seven days.
    • “That year, when USPS delivered a “historically high number of ballots,” DeJoy said they accounted for just 0.1% of its annual mail volume.
    • “We will be even better prepared for 2024,” DeJoy said. “Our network is designed to readily handle a surge in mail volume, just like we do every election and holiday season.”
    • “DeJoy recommends voters mail their ballots early, at least seven days before their state’s election deadline.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated.
    • “COVID-19
      • “There are continued signs of declines in COVID-19 activity in many areas. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are decreasing. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
      • “Vaccinations to prevent fall respiratory virus have started for the 2024-25 respiratory illness season with 4.5% of adults 18 years and older reporting receipt of the updated 2024-25 COVID-19 vaccine and 9.6% reporting receipt of an influenza vaccine. Among adults 75 years and older, 34.0% reported ever receiving an RSV vaccine. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • The University of Minnesota CIDRAP informs us,
    • Wastewater levels for COVID-19 remain high but low for RSV and influenza. Of flu cases identified through specimens testing, the H1N1 strain accounts for 53.5% of cases, H3N2 for 46.5%, and influenza B for 1.2%. Influenza test positivity for the week ending on September 21 was 0.6%.
  • and
    • “A new study on COVID-19’s effects on US infants notes that the proportion of hospitalized babies of mothers vaccinated during pregnancy plunged from 18% in October 2023 to 4% in April 2024, underscoring the need for increased vaccine uptake.
    • “And another report estimates that unexpected infant deaths jumped as much as 14% in 2021 relative to pre-pandemic totals.”
  • and
    • “A pair of new studies on COVID-19 antiviral drugs suggest that resistance mutations that emerge after treatment with nirmatrelvir-ritonavir (Paxlovid) or remdesivir (Veklury) are rare and that almost a third of US adults have never heard of Paxlovid.”
  • The American Hospital Association News points out,
    • “The National Foundation for Infectious Diseases Sept. 25 released a survey showing that less than one in five U.S. adults are concerned about themselves or a family member getting a respiratory virus infection this fall and winter. The survey, conducted in August, found that 20% are concerned about COVID-19, 17% are concerned about flu, 17% are concerned about pneumococcal disease and 16% are concerned about respiratory syncytial virus. Additionally, it found that while 67% of adults agree that an annual flu vaccination is the most effective way to prevent flu-related hospitalizations and deaths, 45% said they do not plan to or are unsure if they will receive a flu vaccine this season, and 38% said they definitely plan to. Regarding COVID-19, 26% of adults said they will definitely get an updated vaccine. Among those for whom a vaccine is recommended, only 21% said they will definitely get an RSV vaccine and 24% said they would definitely receive one against pneumococcal disease.”
  • The New York Times reports,
    • “A possible cluster of bird-flu infections in Missouri has grown to include eight people, in what may be the first examples of person-to-person transmission in the United States, the Centers for Disease Control and Prevention reported on Friday.
    • “If confirmed, the cases in Missouri could indicate that the virus may have acquired the ability to infect people more easily. Worldwide, clusters of bird flu among people are extremely rare. Most cases have resulted from close contact with infected birds.
    • “Health officials in Missouri initially identified a patient with bird flu who was hospitalized last month with unusual symptoms. The patient may have infected one household member and six health care workers, all of whom developed symptoms, according to the C.D.C.
    • “Investigators have not yet confirmed whether any of those seven individuals were infected with the virus, called H5N1, leaving open the possibility that they had Covid or some other illness with flulike symptoms.”
  • and
    • “Major heart defects are more common — but still rare — in babies conceived through certain fertility treatments, including in vitro fertilization, researchers reported on Thursday in the largest study of its kind.
    • “The research, which included medical records of more than seven million Nordic children, also bolstered evidence that I.V.F. is associated with a small but significant uptick in birth abnormalities.
    • “It’s an increased risk, but the absolute risk is very small,” said Dr. Ulla-Britt Wennerholm, the senior author of the paper and a professor of obstetrics and gynecology at the University of Gothenburg in Sweden.
    • “I think that’s a reassuring finding, actually.”
    • “The study focused on children born between 1984 and 2015 in Denmark, Sweden, Norway and Finland as a result of a class of fertility treatments called assisted reproductive technology, the most common of which is I.V.F.”
  • STAT News tells us,
    • “Prostate cancer presents a tricky screening challenge. Catching it early could mean dodging a painful journey with advanced cancer. Yet a sizable majority of prostate cancers are “indolent” — slow growing tumors that most likely would never metastasize during the patient’s lifetime, and whose treatment  would do more harm than good.
    • “Experts have long clashed over these considerations, with some arguing that the harms of PSA testing outstrip the benefits and others adamant that lives are saved with screening. The balance may now be shifting as researchers and physicians find methods that reduce the harms of screening, in particular with the use of MRI. A new study published in the New England Journal of Medicine on Wednesday showed using MRI scans can reduce unnecessary diagnosis and treatment of screen-detected prostate cancer by more than half.
    • “That result should be a reason for experts to rethink prostate cancer screening guidelines with MRI in mind, according to Jonas Hugosson, a professor of urology at the University of Gothenburg in Sweden and the study’s lead author. “In my opinion, this is the last piece of the puzzle to have real evidence that the benefits of prostate screening exceed the harms on a population level,” he said. “This paper is the message to healthcare authorities around the world to look over recommendations for men.”
    • “That may be easier said than done, other experts said. There may not be enough MRI infrastructure to support a prostate screening program requiring the scans.” 
  • STAT News also calls attention to the fact that the “Sickle cell community scrambles to find safe plan after a drug is pulled from the market. Pfizer’s abrupt decision left many feeling they had no guidance on what to do next.”
    • “The vast majority of Americans with the disease are Black, its research long neglected, its care long suffused with racism and stigma. “There’s a lot of people in the sickle cell warrior community where they felt like, historically, they’ve been guinea pigs,” said Habib.
    • “This week, the feeling can cut two ways, in the sense that some patients may have been prescribed a medication that may have been dangerous, and in the sense that some are losing something helpful with no warning. It wasn’t just the news about a drug that some people had been taking daily for years; it was how it was rolled out, with little warning or guidance. One patient advocate said she was too devastated to comment. Another was so shocked she didn’t believe it at first. 
    • “You know I’m just worried about everyone’s safety. I want to make sure no one is having extreme side effects,” said Quannecia McCruse, president and CEO of the Sickle Cell Association of Houston, who had considered quitting her Oxbryta cold turkey this week because she’s done so before and had no issues. Yet she also found the whole thing weirdly precipitous, and wondered if the drug might still end up in the medicine cabinet — perhaps for a more specific group. “Not one sickle cell person is like another.”
  • The New York Times identifies five common signs of dementia other than memory loss
    • Financial problems,
    • Sleep issues,
    • Personality changes,
    • Driving difficulties, and
    • Loss of smell.
  • The New York Times also notes,
    • “Women are increasingly using guns to die by suicide in the United States, challenging long-held assumptions that they will usually resort to less lethal means, according to data released on Thursday by the Centers for Disease Control and Prevention.
    • “Gun-related suicide is most often associated with men, largely because men are more likely than women to purchase guns and to die by suicide. But in 2020, gun-related suicides surpassed poisoning and suffocation for the first time among women and have continued to rise since then.
    • “Suicide attempts with guns are far more lethal than those by other means, and firearm injuries now account for more than half of all suicide deaths.
    • “The findings, drawn from federal health data, showed that in 2022, 20 out of every million women used a gun to die by suicide, up from 14 women in 2002. This marks a 43 percent increase. The report also found that suicide rates have risen among women over the past two decades.”

From the U.S. healthcare business front,

  • The Institute for Clinical and Economic Research follows up on yesterday’s FEHBlog post,
    • “The FDA approved Karuna Therapeutics’ xanomeline tartrate/trospium chloride (also known as KarXT) for schizophrenia yesterday.
    • “ICER released a Final Evidence Report assessing the comparative clinical effectiveness and value of KarXT this year. At ICER’s public meeting, the independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for KarXT compared to generically available aripiprazole. If long-term data confirm KarXT’s benefits and lack of weight gain, KarXT would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year. Karuna Therapeutics [ a subsidiary of Bristol, Myers, Squibb] priced the therapy close to the upper bound of ICER’s recommended range, at $22,500 per year.
    • “ICER’s Chief Medical Officer David Rind, MD, MSc stated:
      • “Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves. Among the important side effects of current treatments is weight gain leading to metabolic syndrome. This, in turn, places patients at risk for cardiovascular events and death. KarXT has a novel mechanism of action and, at least in the short run, does not seem to cause weight gain. This may lead to major health benefits compared with existing treatments, however current evidence on benefits and harms is limited.” 
  • Fierce Healthcare lets us know,
    • “As employers face rising costs, many are looking to rethink plan designs rather than emphasize shifting expenses to workers, according to a new WTW report.
      WTW released its 2024 Best Practices in Healthcare Survey on Thursday, which polled 417 employers representing 6 million workers. It found that these firms are expecting costs to balloon by 7.7% in 2025, compared to an increase of 6.9% in 2024 and 6.5% for 2023.
    • “Despite the increase, however, only 34% told WTW that they intend to shift those costs to employees by raising premiums. Twenty percent said they will push high-deductible health plans or account-based coverage to address costs.
    • “Instead, 52% said they intend to roll out programs that reduce total costs, and 51% said they would use plan designs and network models to steer workers to lower-cost and higher-quality providers.”

Thursday Miscellany

David Ermer–Congress, Obesity, OPM, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Federal News Network lets us know,
    • “The Senate passed a $3 billion supplemental funding bill, allowing the Department of Veterans Affairs to pay veterans’ benefits without delay.
    • “The Senate unanimously passed the supplemental funding bill in a voice vote Thursday. This bill now heads to President Joe Biden’s desk to be signed into law.
    • “VA Secretary Denis McDonough tweeted Thursday that the supplemental funding “will go directly to earned benefits” for about 7 million veterans and their families.”
  • Roll Call reports,
    • “The House is gearing up to go first on a bipartisan stopgap funding package early next week after nailing down the particulars this weekend, lawmakers said Thursday.
    • “The measure would extend current funding levels, with some “anomalies” allowing for higher rates, likely through Dec. 13, a source familiar with the talks said. The plan is to be ready to go with text of the package over the weekend so members can have time to review it before voting early next week.
    • “Rep. Mike Simpson, R-Idaho, a senior Appropriations Committee member, said he expects the continuing resolution to hit the floor around “the first of the week.” The deadline to get a bill through both chambers without triggering a partial government shutdown is Sept. 30, though it is more like Friday, Sept. 27, since that’s the last scheduled day in session.
    • “Simpson said there was some discussion of going an extra week beyond Dec. 13, but that there was basic agreement not to interfere with the holidays. “I’d like to have it done before [Dec. 31] so we can actually have our appropriations staff have a Christmas,” he said.
    • “Senate Majority Leader Charles E. Schumer, D-N.Y., earlier Thursday teed up a separate legislative vehicle in his chamber that could be used to carry a bipartisan deal in case of any House holdups. 
    • “But it appeared that by Thursday afternoon, House Republicans were on board with avoiding a shutdown, even if it meant making tough concessions to the other side.”
  • Healthcare Dive tells us,
    • “On Thursday, a powerful Senate committee voted unanimously to advance two resolutions holding Steward Health Care CEO Ralph de la Torre in contempt for refusing to testify before the committee last week.” * * *
    • “The Senate will consider whether to adopt the measures — civil enforcement, which instructs Senate Legal Counsel to bring a civil suit against de la Torre in the District Court for the District of Columbia; or a criminal contempt resolution, which would refer the matter to the U.S. Attorney for the District of Columbia for criminal prosecution.”
  • Per HHS press releases,
    • Today, the Health Resources and Services Administration (HRSA), an agency within the U.S. Department of Health and Human Services (HHS), announced $240 million in awards to launch and expand mental health and substance use disorder services in more than 400 community health centers across the country that care for more than 10 million people. Health centers are trusted community providers and a primary source of care for individuals across the country who are uninsured, underinsured, or enrolled in Medicaid – making them well-positioned to respond to the urgent need for behavioral health services that are high quality, stigma-free, culturally competent and readily accessible.  These grants will help expand access to needed care to help tackle the nation’s mental health and opioid crises – two pillars of the Biden-Harris Administration’s Unity Agenda for the nation.
  • and
    • Today, the Health Resources and Services Administration (HRSA) at the Department of Health and Hunan Services (HHS) announced the first ever multi-vendor contract awards to modernize the nation’s organ transplant system to improve transparency, performance, governance, and efficiency of the organ donation and transplantation system for the more than 100,000 people on the organ transplant waitlist.
    • The Organ Procurement and Transplantation Network (OPTN) has long faced critiques about lack of transparency, potential for conflicts of interest, IT reliability issues and other structural challenges. As part of the Administration’s transformation of the OPTN, for the first time in 40 years, multiple contractors will provide their expertise and proven experience to improve the national organ transplant system. This transition from a single vendor to multiple vendors to support OPTN operations is a critical step in advancing innovation in the transplant system to better serve patients and their families and implements the bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act signed by the President in September 2023.
  • The U.S. Office of Personnel Management announced the availability of new online resources about the Postal Service Health Benefits Program.
    • Resources include a new landing page with details for PSHB enrollees; information about auto-enrollment where Postal employees will be automatically transitioned from their current plan to a comparable plan in the new PSHB program; and a page providing information on cost savings for enrollees who are also signed up for Medicare Part B or Medicare Advantage through PSHB. 
  • Tammy Flanagan, writing in Govexec, poses a Medicare quiz for federal annuitants.
  • Fedweek offers tips to federal retirees on whom to notify when you move residences.

From the public health and medical research front,

  • The New York Times reports,
    • “This year’s [prestigious] Lasker-DeBakey Clinical Medical Research Award went to three scientists for their work on GLP-1, the hormone that led to drugs like Wegovy (the same compound is the basis for Ozempic), which have transformed the treatment of obesity. They are Dr. Joel Habener, Svetlana Mojsov and Lotte Bjerre Knudsen.
    • “Each of the three honorees played a role at a key moment: finding the new hormone; finding the biologically active shorter form of GLP-1; and, finally, showing that the shorter form elicits weight loss.
    • “Of course, as almost always happens in science, many others also played key roles, and the Lasker Foundation mentioned some as part of its citation. And one of the honorees, Dr. Mojsov, is receiving what many deem a long overdue recognition.”
  • Per Beckers Hospital Review,
    • “Cancer survivors with overweight and obesity showed a 13.9% increased risk of developing a second cancer and a 33.2% increased risk of developing a second cancer related to obesity, according to a study published Sept. 17 in JAMA Open Network. 
    • “Researchers from the American Cancer Society analyzed data from 26,894 cancer survivors in the Cancer Prevention Study II Nutrition study. Participants were surveyed starting in 1992 with follow-up occurring through 2017. Of all participants, 42% were overweight and 17.2% were obese at the time of their first cancer diagnosis.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans informs us,
    • “High-dollar claimants continue to concern employer-sponsored health plans in the U.S. Those that self-fund and purchase medical stop-loss coverage have seen premiums continuing to rise over 10% annually, as reported by the 2024 Aegis Risk Medical Stop-Loss Premium Survey, cosponsored by the International Society of Certified Employee Benefit Specialists. In its 18th edition, this year the survey measured over $1 billion in annual premium across more than 1,100 stop-loss policies and covering more than 1.1 million employees.
    • “When asked about the type of catastrophic health claimants that are their top two or three concerns in the next year, responding plan sponsors cited cancer and specialty pharmacy as the two most prominent. Top claimant concerns include:
      • “Cancer/neoplasms, including leukemia—83%
      • “Specialty pharmacy—50%
      • “Gene and cell therapies—29%
      • “Heart/cardiovascular—27%
      • “Newborn/infant care—24%
      • “Lengthy inpatient hospital stays—23%.
  • Per Beckers Hospital Review,
    • “Five years ago, Dallas-based Tenet Healthcare embarked on a new chapter in the health system’s journey, reducing its debt profile and having its ambulatory surgery center business drive a greater portion of the company’s performance, according to CEO and Chair Saum Sutaria, MD. 
    • “Tenet committed to deleveraging the company, realizing the fair value of assets through divestitures and growing its ambulatory business, United Surgical Partners International, by capitalizing on the shift to outpatient procedures at lower costs.
    • “The proceeds from asset sales reflect their high quality, helping us reduce leverage, which now provides strategic and financial flexibility for future growth,” Dr. Sutaria said Sept. 9 during the Wells Fargo Healthcare Conference. “Our ability to deleverage the company with the types of proceeds we’ve generated … has been very good. We are seeing the company at a place where the leverage generates not only a degree of strategic and financial flexibility, but stability for the organization’s ability to invest in growth over the next few years.”
    • “Tenet, now a 52-hospital system, significantly improved its leverage position this year, selling nine hospitals in high-growth markets in California and South Carolina for a total of $3.9 billion. It also plans to sell its majority stake in five more Alabama hospitals for $910 million this fall. 
    • “Proceeds from these hospital sales are being used to reduce the health system’s debt and expand its outpatient footprint through strategic ASC acquisitions and de novo developments.” 

Midweek update

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • NBC News informs us,
    • “House Republicans on Wednesday defeated their own plan to avert a government shutdown at the end of the month, with the party divided over the length of a short-term funding bill and what, if anything, should be attached to it.
    • “It was an embarrassing blow to Speaker Mike Johnson, R-La., who had yanked the same funding package off the floor last week amid growing GOP defections, only to watch it collapse on Wednesday in a vote that seemed doomed from the start.
    • “The vote was 202-220 with two members voting present. In all, fourteen Republicans voted against the package and three Democrats voted for it.
    • “Thirteen days before money runs out for the federal government, there is still no bipartisan plan to stave off a shutdown. While the GOP-led House could try again, the focus now likely shifts to the Senate, where leaders in both parties agree a shutdown would be disastrous weeks before the election.”
  • Govexec adds,
    • “Legislation to cover a $3 billion shortfall in veterans’ benefits through the end of the month passed the House Tuesday, three days before benefits could be disrupted.  
    • “Lawmakers passed the Veterans Benefits Continuity and Accountability Supplemental Appropriations Act by voice vote Tuesday evening, sending it to the Senate ahead of a Friday deadline to ensure the Veterans Affairs Department can process benefit payments for 7 million veterans. * * *
    • “Senate Veterans’ Affairs Committee Chairman Jon Tester, D-Mont., said in a statement Tuesday that it was critical that the Senate move with haste to pass the legislation.”
  • STAT News reports,
    • “A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities, and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives.
    • “Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth. The two-year telehealth extension unanimously passed on Wednesday by the House Energy & Commerce Committee is very similar to bills advanced in May by Commerce’s health subcommittee and the House Ways & Means Committee. 
    • “The two bills set up the House position heading into negotiations with the Senate on extending the telehealth policies, which expire at the end of December.” 
  • Per Federal News Network,
    • “House Democrats are pushing harder to try to help federal employees more easily access IVF treatments. A new bill, called the Right to IVF Act, rolls together four previous bills all aiming to broaden fertility coverage nationwide. Part of the legislation would require carriers in the Federal Employees Health Benefits Program to increase their coverage of IVF for FEHB enrollees. The Democrats who introduced the bill are calling for a House floor vote, but so far, the legislation has no Republican co-sponsors.(Right to IVF Act – Reps. Gerry Connolly (D-Va.), Susan Wild (D-Pa.), Rick Larsen (D-Wash.) and Rosa DeLauro (D-Conn.))”
  • and
    • “Federal benefits for health and retirement are a major recruitment and retention influence for employees, especially for early-career talent.
    • “Women as well as individuals in younger generations ranked the importance of federal benefits more highly than older or male employees, according to the results of the 2023 Federal Employee Benefits Survey (FEBS) from the Office of Personnel Management, obtained exclusively by Federal News Network.
    • “The benefits stemming from the Federal Employees Health Benefits (FEHB) program and the paid parental leave program are particularly important to younger generations of employees, OPM’s survey showed. Specifically, 94% of millennial and Gen Z respondents said the FEHB was either “important” or “extremely important” to them, compared with 84% of baby boomers and older generations who gave the same response.
    • “It is clear that these major benefit programs have an impact on both recruiting and retaining talent in the federal government, making it critical to continuously improve these benefits to meet employee needs,” OPM wrote in the survey results.”
  • A commentator writing in Real Clear Health commends the FEHB Program for being a catalyst for change in women’s health care and suggests three improvements:
    • Provide solutions for perimenopause and menopause
    • Provide a safety net for caregivers, and
    • Provide enhanced family planning and maternal care.
  • Mercer Consulting offers FAQs on the Supreme Court’s recent Loper Bright decision.
    • “The US Supreme Court overturned a 40-year-old principle of administrative law known as the Chevron deference doctrine (Loper Bright Enterprises et al. v. Raimondo, Secretary of Commerce, et al.). That doctrine required courts to defer to administrative agencies’ reasonable interpretation of a federal law that is silent or ambiguous. Now, federal courts must exercise independent judgment when determining the best interpretation of a statute and cannot simply defer to agency interpretations, even when they are reasonable. This will likely increase courts’ scrutiny of federal agency regulations that are subject to legal challenges. These FAQs provide high-level information about the case and its potential impact on employee benefit plans and their sponsors. Also, this Mercer US Health News 15-minute video highlights the practical implications of this opinion on employer-sponsored health plans.”

From the public health and medical research front,

  • MedPage Today lets us know,
    • “The new COVID-19 variant XEC may overtake others in circulation to become dominant in the coming months, experts said but will not prompt a meaningful change in symptoms or vaccine response.” * * *
    • “XEC represents a fairly minor evolution relative to the SARS-CoV-2 diversity currently in circulation, and is not a highly derived novel variant such as those that were granted Greek letters,” like Alpha, Delta, and Omicron, Francois Balloux, PhD, a computational biologist at University College London and director of the UCL Genetics Institute, said in a Science Media Centre statement.
    • “Experts noted that while XEC may have a small advantage in transmission, available vaccines are still likely to provide protection from serious illness.
    • “XEC is a “recombinant variant of some of the other Omicron lineages that have been around for a while, and it does appear to be more immune evasive, giving it a transmissibility advantage in the population with the immunity that it has,” Amesh Adalja, MD, of the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today. “But it doesn’t really change anything, just like the last variant didn’t change anything, or the one before that, one before that, or the one before that.”
  • NBC New points out,
    • “Black women are more likely than white women to die from even the most treatable types of breast cancer, a study published Tuesday in the Journal of Clinical Oncology found.
    • “The findings, experts say, underscore that it’s racial disparities, not biology, driving the biggest differences in death rates between Black and white women. While Black women and white women are diagnosed with breast cancer at similar rates, Black women are 40% more likely to die from the disease.” * * *
    • “If you look at breast cancer data from 40 years ago, there really weren’t differences in mortality for breast cancer between Black and white women. We weren’t very good at treating and diagnosing it. But as we’ve gotten better, the gap between white and Black women has grown,” [lead author Dr. Erica] Warner said. “That is problematic, but that also tells us we have our foot on the pedal for these differences. If we can create them, we can eliminate them.” 
  • STAT News reports,
    • “A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up.
    • “On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks. 
    • “Notably, only two of 71 patients who received a high dose of therapy have shown signs of ocular inflammation, 4D said. In 2021, another leading contender, Adverum, was set back after a patient with a related disease went blind in one eye. 
    • “I think it’s very positive and there’s a good chance they’ll be able to move toward approval,” said Ron Crystal, chair of genetic medicine at Weill Cornell Medical Hospital, who has served as a scientific adviser to and has stock in Adverum.”
  • The New York Times notes,
    • “Adults under age 50 have been developing breast cancer and colorectal cancer at increasingly higher rates over the last few decades, and alcohol use may be one factor driving the trend, according to a scientific report published on Wednesday.
    • “The report, by the American Association for Cancer Research, highlights scientific breakthroughs that have led to new anticancer drugs and improved overall survival.
    • “But the authors also described a troubling pattern: Even as cancer death rates have declined, the overall incidence of several cancers has been rising inexplicably, with an especially alarming increase among younger adults in cancers of the gastrointestinal system, like colorectal cancer.
    • “The report estimates that 40 percent of all cancer cases are associated with modifiable risk factors. It recommends reducing alcohol consumption, along with making lifestyle changes such as avoiding tobacco, maintaining a healthy diet and weight, exercising, avoiding ultraviolet radiation and minimizing exposure to pollutants.”
  • Per NIH press releases,
    • “Results from a large study supported by the National Institutes of Health show that protein analyses taken during the first trimester of pregnancy did not improve predictions for identifying people at risk for experiencing conditions related to having high blood pressure during pregnancy. Since there is an urgent need to better predict people at risk for developing conditions related to having high blood pressure during pregnancy, also called hypertensive disorders of pregnancy, researchers have been studying if proteins taken from blood or urine samples could provide this insight. This study provides the largest data to date based on using protein analyses from blood samples during early pregnancy.”
  • and
    • “Researchers at the National Institutes of Health (NIH) and their collaborators have identified a protein, known as RNF114, that reverses cataracts, a clouding of the eye’s lens that occurs commonly in people as they age. The study, which was conducted in the 13-lined ground squirrel and rats, may represent a possible surgery-free strategy for managing cataracts, a common cause of vision loss.  The study published in the Journal of Clinical Investigation.
    • “Scientists have long searched for an alternative to cataract surgery, which is effective, but not without risk. Lack of access to cataract surgery is a barrier to care in some parts of the world, causing untreated cataracts to be a leading cause of blindness worldwide,” said Xingchao Shentu, M.D., a cataract surgeon and the co-lead investigator from Zhejiang University, China.” * * *
    • “According to the scientific team, these findings are proof-of-principle that it is possible to induce cataract clearance in animals. In future studies, the process will need to be fine-tuned so scientists can stimulate specific protein degradation to see how to precisely regulate protein stability and turnover. This mechanism is also an important factor in many neurodegenerative diseases, they said.”
  • and
    • “A clinical trial supported by the National Institutes of Health (NIH) was stopped early after researchers found sufficient evidence that a drug used to treat bone marrow cancer and Kaposi sarcoma is safe and effective in treating hereditary hemorrhagic telangiectasia (HHT), a rare bleeding disorder that affects 1 in 5,000 people worldwide. The trial results, which are published in the New England Journal of Medicine, detail how patients with HHT given the drug, called pomalidomide, experienced a significant reduction in the severity of nosebleeds, needed fewer of the blood transfusions and iron infusions that HHT often demands, and showed improved quality of life.
    • “Finding a therapeutic agent that works in a rare disorder is highly uncommon, so this is a real success story,” said Andrei Kindzelski, M.D., Ph.D., of NIH’s National Heart, Lung, and Blood Institute. “Before our trial, there was no reliable therapeutic to treat people with HHT. This discovery will give people who suffer with this disease a positive outlook and better quality of life.”

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “St.-Louis-based Ascension reported a $79 million operating loss (-0.3% margin) for the 10 months ending April 30, a substantial improvement on the $1.2 billion operating loss in the previous 10-month period. 
    • “The results include $402 million in one-time, non-cash write-downs and non-recurring losses.
    • “In May and June 2024, operations were hampered by the May ransomware attack, resulting in reduced revenues from the associated business interruption along with costs incurred to address the issues and other business-related expenses.
    • “Despite this incident, Ascension drove a $1.2 billion operational improvement year over year for the 10 months ending April 30. The 136-hospital system’s economic improvement plans focused on volume growth, rates and pricing, and cost levers. 
    • “The results are a notable improvement on the $3 billion operating loss (-5.5% margin) reported in fiscal year 2023. Including the cyberattack, Ascension reported a $1.8 billion (-4.9% margin) loss in FY 2024. 
    • “Ascension is also reorganizing its portfolio with several transactions in multiple markets.”
  • Healthcare Dive tells us,
    • “Community Health Systems’ Northwest Urgent Care has signed a definitive agreement to purchase 10 Arizona urgent care centers from Carbon Health for an undisclosed price, according to a press release this week.
    • “The acquisition, which is expected to close in the fourth quarter, will grow CHS’ integrated health network to more than 80 care sites in the Tucson, Arizona region, according to CHS.
    • “The acquisition is a reversal from CHS’ recent string of hospital divestitures, which have been integral to helping the operator deleverage its portfolio.”
  • Per BioPharma Dive,
    • “Organon has agreed to buy Roivant’s dermatology subsidiary Dermavant for $175 million upfront plus more than $1 billion in potential additional payments if certain milestones are hit.
    • “With the acquisition, Organon will gain Dermavant’s cream called Vtama, which was approved in 2022 to treat plaque psoriasis. The medicine is also awaiting action from the Food and Drug Administration that could expand its use to include atopic dermatitis, commonly known as eczema.
    • “Approval in eczema, expected in the fourth quarter, would trigger a $75 million payment, Organon said Wednesday. The deal also includes $950 million in potential commercial milestone payments as well as tiered royalties on net sales to Dermavant shareholders. Roivant owns the majority of Dermavant.”
  • Fierce Healthcare points out,
    • “If a patient receives a continuous glucose monitor device through their medical benefit, they may be more adherent and may have lower costs, according to a new analysis.
    • “Researchers at CCS, which offers clinical services and home delivery for medical supplies for people with chronic conditions, published the peer-reviewed study this week in the Journal of Medical Internet Research Diabetes (JMIR) and found that patients who secured the monitors through their medical coverage had 23% higher rates of adherence.
    • “The study included data on 2,356 people, with 1,178 in the pharmacy benefit group and 1,178 in the durable medical equipment cohort. In addition to greater adherence, the study found that people who received the devices through their medical benefit had 35% lower average annual total costs of care.
    • “And, for patients who were not adherent to their devices, there was a higher rate of reinitiation (22%) for those in the medical benefit compared to those who received the glucose monitors through their pharmacy benefit (11%).”
  • Per MedTech Dive,
    • “Zimmer Biomet will phase out sales of its CPT Hip System by December due to concerns about the risk of thigh bone fractures, the Food and Drug Administration said in a Tuesday notice. 
    • “Despite plans to pull the device, the FDA said it is still concerned about the hip system being implanted in new patients, and it is “working with the manufacturer to address these concerns.” 
    • “Earlier this month, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) flagged a higher risk of thigh bone fracture after surgery with the CPT Hip System, compared with similar hip replacement devices. While the analysis is currently unpublished, the British Hip Society and the British Orthopaedic Association advised against using the implant for elective surgery unless in exceptional circumstances.”

It’s World Patient Safety Day

David Ermer–Uncategorized–
  • MedPage Today offers experts recommendations that “‘Failing Wisely’ Can Promote a Safer Healthcare System. — Don’t assume old strategies and new technologies will improve patient safety.”
  • Modern Healthcare reports,
    • “The Centers for Disease Control and Prevention is launching a program to help hospitals reduce diagnostic errors and provide more safe, accurate patient care, the agency announced Tuesday.
    • “Missed, delayed or wrong diagnoses can occur due to a variety of factors, including communication breakdowns and technological issues, said Dr. Preeta Kutty, deputy associate director for science in the division of healthcare quality promotion at the CDC. Every year, diagnostic errors contribute to around 371,000 deaths and 424,000 permanent disabilities, according to a 2023 study published in The BMJ, a peer-reviewed medical journal.
    • “The Agency for Healthcare Research Quality and Centers for Medicare and Medicaid Services worked with the CDC on recommendations for clinicians and healthcare leaders to cut down on those diagnostic errors as part of the new core elements for diagnostic excellence.
    • “The program will add to the CDC’s core elements for antibiotic stewardship and sepsis management.”
  • AHRQ released a report to Congress on September 16,
    • “The number of sepsis-related inpatient stays at non-federal acute care hospitals in the United States increased from 1.8 million in 2016 to 2.5 million in 2021, with a faster rate of increase following the emergence of COVID-19 in 2020, according to a report to Congress by the Agency for Healthcare Research and Quality (AHRQ) at the U.S. Department of Health and Human Services (HHS). The COVID 19 pandemic led to a noticeable rise in sepsis-related hospitalizations, hospital costs, and in-hospital mortality, particularly for patients with a COVID-19 diagnosis.
    • The report, titled “An Assessment of Sepsis in the United States and its Burden on Hospital Care,” responds to language in the Joint Explanatory Statement that accompanied the Consolidated Appropriations Act for Fiscal Year 2023, which directed the agency to conduct a comprehensive set of studies that calculate the morbidity, hospital readmissions, and mortality related to sepsis.  The report examines sepsis among all patients as well as among specific patient populations, including adults, pregnant women, children, and newborns.  The report also examines the association of pandemic-related changes in the healthcare system with the burden of sepsis.”

From Washington, DC,

  • Roll Call tells us,
    • “The House is set to vote Wednesday on Speaker Mike Johnson’s six-month stopgap spending plan despite near certain defeat in the face of GOP defections and almost unanimous Democratic opposition. 
    • “The bill has remained unchanged from last week, when Johnson pulled it from the floor before an expected vote. It includes a controversial elections bill that would require those registering to vote to show proof of citizenship, which Democrats say will make it more difficult for legal voters who can’t obtain the right documentation in time.
    • “Johnson, R-La., confirmed the plan in a statement Tuesday morning. He said that Congress has “an immediate obligation to do two things: responsibly fund the federal government and ensure the security of our elections.”
  • Per STAT News,
    • “The Senate failed again Tuesday to advance legislation that would protect access to in vitro fertilization, the latest partisan battle over reproductive health care amid the 2024 presidential election.  
    • “The 51-44 vote on the Right to IVF Act, which would bar state restrictions on the procedure and require insurance coverage, fell short of the 60 votes needed to pass, just as it did in June — and as Democrats expected it would. For them, the vote put many Senate Republicans on the record again as seemingly opposing broad IVF access and delivered new attack lines for an election that many see as a referendum on reproductive rights.”
  • Fedweek informs us
    • “Plans that will participate in the new Postal Service Health Benefits program, which will replace the FEHB for postal employees and retirees effective in January, will offer largely the same options they have offered in the FEHB, a fact sheet recently posted by the USPS shows.”
  • Healthcare Dive lets us know,
    • “Cigna is following through on promises to more aggressively defend its pharmacy benefit manager.
    • “On Tuesday, the healthcare company’s PBM, Express Scripts, sued the Federal Trade Commission over the agency’s recent report showing how the drug middlemen could be contributing to rising drug prices, calling the report “unfair, biased, erroneous, and defamatory.”
    • “The lawsuit asks a federal judge to order the FTC to withdraw the report and recuse FTC Chair Lina Khan from further action against Express Scripts.
    • “We don’t take this step lightly, but … we cannot let the FTC’s unlawful actions and false information stand,” Andrea Nelson, Cigna’s chief legal officer, said in a statement.”
  • The American Hospital Association News points out,
    • “The Health Resources and Services Administration Sept. 17 told Johnson & Johnson that the company’s publicly announced plans to implement a 340B rebate model “violates J&J’s obligations under the 340B statute, and HRSA expects J&J to cease implementation of it.”  
    • “Because J&J’s rebate proposal, if implemented, violates J&J’s obligations under the 340B statute, it subjects J&J to potential consequences, such as termination of J&J’s Pharmaceutical Pricing Agreement (PPA),” HRSA wrote Sept. 17. In addition, HRSA told J&J that the 340B statute provides for “[t]he imposition of sanctions in the form of civil monetary penalties” on “any manufacturer with an agreement under this section that knowingly and intentionally charges a covered entity a price for purchase of a drug that exceeds the maximum applicable price under subsection (a)(1).”
  • Per HHS press releases,
    • Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced nearly $100 million in awards to grow, support, and strengthen the health workforce and improve access to quality care in high-need areas across the country. The announcement was made in conjunction with an HHS Health Workforce Roundtable convened as part of HHS Secretary Xavier Becerra’s Health Workforce Initiative. * * * “For a list of awards, visit: https://www.hrsa.gov/about/news/fy24-workforce-award-announcements.”
  • and
    • “Today the U.S. Department of Health and Human Services, through its Administration for Community Living (ACL), delivered to Congress a progress report on federal implementation
       of the 2022 National Strategy to Support Family Caregivers
    • “The strategy presents a vision, establishes goals, and provides recommendations for ensuring that family caregivers have the support and resources they need. The strategy also includes commitments from 15 federal agencies to nearly 350 actions to implement these recommendations. Today, nearly all these actions have been completed or are in progress, and federal agencies have committed to almost 40 new actions since the strategy’s release.” * * * “Learn more about the RAISE Family Caregiving Advisory Council at ACL.gov/RAISE and the Advisory Council to Support Grandparents Raising Grandchildren at ACL.gov/SGRG.”

From the public health and medical research front,

  • The New York Times offers tips on training your tendons.
    • “When it comes to exercise, muscles and bones are clearly the stars of the show. But to feel your best and age well, you also need to take a little time each week to exercise the body’s supporting cast: connective tissues like ligaments and tendons, especially if you’ve injured them in the past.
    • “How you do it matters. What works for ligaments doesn’t work for tendons, and vice versa.
    • “Each part responds to different stimulus,” said Jay Dicharry, a professor of physical therapy at Oregon State University and the author of “Running Rewired.” “Just as you don’t treat each of your children the same, you shouldn’t treat all of your body parts the same way.”
  • The National Institutes of Health posted its latest Research Matters newsletter on topic of “Blood test for CVD risk | Smart mask | Heat-seeking mosquitoes.”
  • Per an NIH press release,
    • “Adults who use the prescription drug metformin to treat their type 2 diabetes have a lower risk of developing long COVID or dying after a COVID-19 infection than people with diabetes who take other anti-diabetes medications, according to a large study supported by the National Institutes of Health (NIH). The findings, published in the journal Diabetes Care, were based on health data from millions of U.S. patients and could have broader implications for use of metformin in long COVID prevention generally. The study is part of the NIH-funded Researching COVID to Enhance Recovery (NIH RECOVER) Initiative.”
  • MedTech Dive notes,
    • “A patient with amyotrophic lateral sclerosis has used Synchron’s brain-computer interface (BCI) technology to control his smart home, the company said Monday.
    • “The patient can use Synchron’s BCI and the Tap to Alexa feature on an Amazon Fire tablet to turn on lights, make video calls, play music and shows, read books and buy products online without using his hands or voice. 
    • “Synchron is trialing the integration between its BCI and Alexa to allow people who are severely paralyzed to interact with Amazon’s smart speaker and other connected devices in their homes.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Multispecialty care provider Summit Health is expanding its footprint in New Jersey this fall.
    • “New York-based Summit, part of Walgreens-backed VillageMD, opened a 78,000-square-foot hub facility in Fair Lawn, New Jersey, this week and plans to open another 34,000-square-foot location in Bridgewater in late October, according to a Tuesday news release. Details of the financial investment were not disclosed.
    • “Hub locations are larger than other Summit clinics, which are typically 20,000 square feet or less, and offer more specialties in one place, a spokesperson said. Patients will have access to service lines including gastroenterology, obstetrics and gynecology, orthopedics, urology and dermatology, according to the release.”
  • Per Fierce Healthcare,
    • “Amazon has added virtual behavioral health provider Talkspace to its health conditions program, a service it rolled out in January to help connect customers with virtual care benefits.
    • “Talkspace is Amazon’s second digital health partner following the initial rollout of the health conditions program with virtual-first chronic care provider Omada Health.
    • “The online retail giant launched its health conditions program to collaborate with digital health companies and help customers find and enroll in virtual care benefits available to them through their employer or health plan at no extra cost. With Omada Health, Amazon offered easier access to virtual care benefits for managing conditions like diabetes and hypertension. 
    • “Omada and Amazon announced their collaboration and the rollout of the health conditions program at the 2024 J.P. Morgan Healthcare Conference, marking the first virtual diabetes prevention, diabetes and hypertension provider available in Amazon’s digital health benefits program.
    • “By adding Talkspace to the program, individuals can discover and enroll in their health insurance benefits for mental health services at no extra cost or for a small copay, according to the companies.”
  • and
    • “Cigna is rolling out a new E-Treatment program for its members in partnership with its MDLIVE unit.
      Beginning this month, Cigna members can quickly connect for urgent care from board-certified doctors without the need for phone or video calls. They can connect to MDLIVE’s portal and submit a virtual clinical interview and typically receive a personalized diagnosis and treatment plan within an hour.
    • “The program is designed to assist in a convenient way with many common, low-risk needs like allergies, ear infections, urinary tract infections and respiratory conditions like the flu, Cigna said.
    • “Our customers lead busy lives, and getting care shouldn’t be put on the backburner,” said Heather Dlugolenski, U.S. employer strategy officer at Cigna Healthcare, in the press release. “By offering customers multiple ways to conveniently connect with board-certified clinicians, they can be more effective with their time and continue putting their health and vitality first.”
  • Per FiercePharma,
    • “An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer.
    • “The FDA has greenlighted Novartis’ Kisqali, used in combination with an aromatase inhibitor, for the adjuvant treatment of HR-positive, HER2-negative stage 2 and 3 breast cancer that’s at high risk of recurrence following surgery, the company said Tuesday.
    • “The expanded label separates Kisqali from Lilly’s Verzenio by covering patients who don’t have cancer cells in their lymph nodes. Verzenio’s first-in-class nod in HR+/HER2- breast cancer is limited to patients with nodal involvement. 
    • “Kisqali’s broad indication almost doubles the size of the patient population eligible for postsurgical adjuvant therapy within the CDK4/6 inhibitor class, Novartis noted.
    • “In November, Novartis estimated that an inclusive node-agnostic label in the adjuvant setting could translate into more than $3 billion in additional annual peak sales for Kisqali, bringing the drug’s total peak projection to $7 billion.”
  • MedCity News tells us “Three-quarters of U.S. providers and payers say they have increased their IT spending over the past year, according to a new report from Bain & Company and KLAS Research. Both providers and payers are investing in cybersecurity technology, as well as AI tools.”