Thursday Miscellany

OPM

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “Two U.S. senators are aiming to crack down on deceptive or misleading online promotion of weight-loss and other prescription drugs by telehealth firms and social-media influencers who profit from their posts.
    • “New bipartisan legislation proposed by Sens. Dick Durbin (D., Ill.) and Mike Braun (R., Ind.) would authorize the Food and Drug Administration to warn and potentially impose costly fines on those who post false information online about medicines or omit important information about a drug’s safety risks.
    • “One impetus for the bill, according to a Senate aide, is the 2024 reporting by The Wall Street Journal about how social media has fueled demand for Ozempic and Wegovy from Novo Nordisk as well as other drugs used for weight loss. The Journal found that posts on platforms such as TikTok, YouTube and Instagram often omit information about difficult side effects, and that some influencers and companies profit from the posts.”
  • Healthcare Dive informs us,
    • “Top executives at major pharmacy benefit managers are standing behind recent testimony on the Hill that put them in hot water with the chair of the powerful House Oversight Committee.
    • “Chair James Comer, R-Ky., accused Patrick Conway, the CEO of UnitedHealth’s Optum Rx; Adam Kautzner, the president of Cigna’s Express Scripts; and David Joyner, the president of CVS’ Caremark, of lying during a July hearing, and gave them until Wednesday to correct their statements or face potential fines or jail time.
    • “Optum Rx, Caremark and Express Scripts have responded to Comer and declined to change any testimony, the companies confirmed. The House Oversight Committee is “reviewing the PBMs’ written responses as well as the additional documents and information they provided,” according to a spokesperson.”
  • Per Fierce Healthcare,
    • “Steward Health Care CEO Ralph de la Torre, M.D., defied a subpoena to testify before Congress Thursday morning, leading heads of the investigating committee to promise civil enforcement and criminal charges for the executive.
    • “During the summer, the Senate Committee on Health, Education, Labor and Pensions (HELP) had voted to issue its first subpoena in over 40 years. Chairman Bernie Sanders, D-Vermont, said at the time that de la Torre needed to “explain to Congress the financial chicanery that made him extremely wealthy while the hospitals he managed went bankrupt.”
    • “Sanders and Committee Ranking Member Bill Cassidy, M.D., R-Louisiana, said Thursday that de la Torre’s legal team suggested he would be in attendance until they received a letter eight days ago. The letter informed the committee that he would not be attending out of concern that his testimony could harm the company’s ongoing bankruptcy proceedings. His legal counsel also suggested that the senators planned to turn their hearing into a “pseudo-criminal proceeding.”
    • “The committee overruled the letter a day later and told de la Torre to show up anyway. He did not.”
  • American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention Sept. 12 released a rural health strategic plan which includes the agency’s key priorities, objectives and outcomes in rural health for the next five years. The CDC’s priorities include advancing results-based engagement with partners and communities to address rural health challenges, strengthening rural health infrastructure and the workforce, advancing rural health science and improving rural health preparedness and response capacity. As part of the fiscal year 2023 Congressional appropriations, CDC created an Office of Rural Health to coordinate its growing rural health portfolio across the agency.”
  • Per HHS press releases,
    • “Today, the Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Health (OASH) and the Health Resources and Services Administration (HRSA), announce a Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984. * * *
    • “The proposed rule change, if finalized, would remove clinical research and institutional review board (IRB) requirements for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. The proposed rule, Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act, is based on rigorous analysis of clinical data.
    • “If the proposed rule is finalized, HHS expects this rule will allow a larger number of transplant centers to conduct HOPE Act kidney and liver transplants and will help reduce the stigma and health disparities associated with HIV. 
    • “Public comments on the NPRM are due 30 days after publication of the NPRM in the Federal Register on October 15, 2024, at 11:59 PM ET. The NPRM may be viewed or downloaded at: Federal Register: Public Inspection: Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act.”
  • and
    • “Today, the U.S. Department of Health and Human Services, through the Office of Research Integrity (ORI), finalized the 2024 Public Health Service (PHS) Policies on Research Misconduct. This rule updates the 2005 regulation and clarifies requirements for addressing research misconduct in PHS-funded research.” * * *
    • “The research landscape has changed over the past 20 years with new technology, scientific advances, and globalization, which increases the need for ORI to remain nimble and collaborative. ORI is committed to keeping up with the needs of the research community,” said ORI Director Sheila Garrity. “The Final Rule aims to adapt to our current time, support our colleagues in the research community, and fortify ORI’s role in fostering research integrity and preserving public trust in science for future generations.”
    • “The Final Rule takes effect January 1, 2025, and becomes applicable on January 1, 2026. In the coming months, ORI plans to release sample policies and guidance to help prepare PHS-funded entities. The Final Rule can be found here https://www.federalregister.gov/public-inspection/2024-20814/public-health-service-policies-on-research-misconduct.”
  • FedWeek discusses the all-important Five-Year Rule which generally is a prerequisite for continuing FEHB and FEGLI coverage into federal retirement.

From the public health and medical research front,

  • STAT News reports,
    • “Disease investigators have not been able to determine how a person in Missouri with no known exposures to animals or poultry became infected with an H5 bird flu virus, the principal deputy director of the Centers for Disease Control and Prevention said Thursday.
    • “But Nirav Shah said the ongoing investigation has turned up no evidence of onward spread of the virus, suggesting this case may turn out to be a one-off infection that defies explanation.
    • “Here’s the bottom line: Our influenza surveillance system is designed to find needles in haystacks,” Shah said at a news briefing. “Here in this case, we found such a needle, but we don’t know how it got there. Our investigation continues, and we will keep everyone updated as we learn more.”
  • and
    • “Gilead said Thursday that its twice-yearly antiviral reduced the risk of HIV infections by 96% compared to an expected rate of infection in a second pivotal trial, paving the way for the likely approval of the drug for pre-exposure prophylaxis, or PrEP.
    • “The study, which enrolled cisgender men, transgender women, transgender men, and gender nonbinary individuals who have sex with partners assigned male at birth, also showed that the antiviral, called lenacapavir, was 89% more effective than a daily pill called Truvada.
    • “Specifically, two out of the 2,180 participants taking lenacapavir contracted HIV, while nine out of the 1,087 individuals in the Truvada group did.
  • The New York Times reports,
    • One dozen of 36 cinnamon products tested by a consumer group contained elevated levels of lead, according to a study released on Thursday that reinforced concerns about metals in foods after tainted cinnamon applesauce poisoned dozens of children last year.
    • The study, by Consumer Reports, documented levels that were far lower than the amounts discovered last year.
    • The Consumer Reports team tested the spice and found high levels in lead in 12 items sold at discount stores and ethnic markets, with lead levels reaching 3.5 parts per million. New York, the only state with tough lead standards in spices, recalls spices — among them curry powder, chili powder, cumin and five-spice powder — with more than one part per million of lead. Consumer Reports advised that people throw out items with that amount.
  • The American Hospital Association News lets us know,
    • “The AHA Sept. 12 released a new report that found hospital and health system performance on key patient safety and quality measures was better in the first quarter of 2024 than it was prior to the COVID-19 pandemic, and that hospitals made these improvements while caring for patients with more significant health care needs.  
    • “Hospitals and health systems are continuously working to advance patient safety and quality — which is always the hospital field’s top priority,” said AHA President and CEO Rick Pollack. “This report shows hospitals have made significant improvements on pre-pandemic performance in key patient safety outcomes. Hospitals’ commitment to improving patient outcomes and enhancing the patient experience continues to drive these efforts forward.”  
       
  • Beckers Hospital Review points out,
    • “Among 95 patients who are overweight or obese, an experimental daily pill from Novo Nordisk reduced their mean body weight by 13.1%, NBC News reported Sept. 10. 
    • “Novo Nordisk, the manufacturer of Ozempic, Wegovy, and other popular GLP-1 drugs, shared the phase 1 trial results at the European Association for the Study of Diabetes annual meeting. 
    • “The Denmark-based company recruited 124 patients and randomly assigned them either a placebo or its daily pill candidate, amycretin, to take for 12 weeks. Amycretin is a GLP-1 and protein-based unimolecular amylin, according to an abstract on the association’s website. 
    • “The trial’s primary endpoint was the number of treatment-emergent adverse events — which were found to be mild to moderate — and body weight changes were a key exploratory endpoint. The weight reduction results are “remarkable,” according to the abstract.
  • Per MedPage Today,
    • “The FDA warned that fezolinetant (Veozah), a hormone-free pill for moderate to severe hot flashes caused by menopause, could cause rare but serious liver injury.
    • “If women experience any signs or symptoms suggesting liver injury, they should stop fezolinetant, the agency said. Symptoms include new-onset fatigue, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or right upper quadrant pain.
    • “Treatment discontinuation may prevent worsening liver injury and may potentially return liver function to normal, the FDA explained.”
  • Per an NIH press release,
    • “National Institutes of Health (NIH) researchers and collaborators have found that being a carrier for sickle cell disease, known as having sickle cell trait, increases the risk of blood clots, a risk that is the same among diverse human populations that may not traditionally be associated with sickle cell disease. The study provides estimated clinical risks for people with sickle cell trait, which can inform clinical practice guidelines. Researchers examined the largest and most diverse set of people with sickle cell trait to date, which includes data from over 19,000 people of various ancestral backgrounds with sickle cell trait.  
    • The study, published in Blood Advances was led by researchers at National Human Genome Research Institute (NHGRI), part of NIH, The Johns Hopkins University School of Medicine, Baltimore, and the company 23andMe, South San Francisco, California.  * * *
    • “This study, therefore, provides important insights about patterns of venous blood clots and suggests a unique mechanism of blood clotting in people with sickle cell trait,” said Rakhi Naik, M.D., clinical director for the Division of Hematology at Johns Hopkins University, Baltimore, who co-led the study. “Knowing the risks of blood clots in people with sickle cell trait is important for situations such as surgeries or hospitalizations, which add to the risk of developing serious blood clots.” 
    • Over 2 million people in the United States have sickle cell trait. People with sickle cell trait have one copy of the genomic variant that causes sickle cell disease, a genetic condition that causes red blood cells to become rigid and sticky, which blocks blood flow. While people with sickle cell trait typically do not have any associated health complications, they are carriers for sickle cell disease. In rare cases, sickle cell trait has been found to be a risk factor for health complications such as muscle breakdown, presence of blood in the urine and kidney disease.  
  • Per Healio,
    • “Nearly one in 20 adults in the U.S. are estimated to have atrial fibrillation, many more than previous studies had indicated, according to new data out of the University of California, San Francisco.
    • “Atrial fibrillation doubles the risk of mortality, is one of the most common causes of stroke, increases risks of heart failure, myocardial infarction, chronic kidney disease and dementia, and results in lower quality of life,” Jean Jacques Noubiap, MD, PhD, postdoctoral scholar at University of California, San Francisco, said in a press release. “Fortunately, atrial fibrillation is preventable, and early detection and appropriate treatment can substantially reduce its adverse outcomes.”
  • The Institute for Clinical and Economic Review announced the release of a Draft Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease. The Public comment period now open until October 8, 2024; Requests to make oral comment during public meeting also being accepted.

From the U.S. healthcare business front,

  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.
    • Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.” 
  • McKinsey and Company explain why the U.S. physician shortage isn’t going anywhere.
  • STAT News reports,
    • “A new [medical debt relief model] pioneered in North Carolina shows how hospitals could make money off of a larger national program.
    • “In North Carolina, hospitals are set to collect billions in federal money to cancel patients’ medical debt and implement new policies to help prevent debt from accumulating in the first place. The funding comes as part of the state’s Medicaid expansion.
    • “Hospitals have significant political power to work federal programs to their advantage, and the template opens the door to other creative ways to use taxpayer funds to pay providers for medical debt. Read the full case study here.”
  • Beckers Payer Issues notes,
    • “Anthem Blue Cross Blue Shield is requesting payments from some providers it alleges falsified patients’ medical records when prescribing Ozempic, Bloomberg reported Sept. 12. 
    • “A spokesperson for Elevance Health, which owns Anthem BCBS, told Bloomberg it contacted a small number of providers about repayments for Ozempic prescribed to their patients. In some cases, the amount of repayment requested was more than $1 million. 
    • “Representatives for Elevance told Bloomberg that Anthem BCBS only covers Ozempic for patients with Type 2 diabetes. The drug is not approved by the FDA for weight loss, but is often prescribed off-label for that purpose.” 
  • Per Becker’s Hospital Review,
    • “A Wilmington, Del.-based physician has agreed to pay more than $1 million to settle allegations he violated the False Claims Act by ordering medically unnecessary durable medical equipment for Medicare and Federal Employees Health Benefits Program patients. 
    • “Vishal Patel, MD, referred patients for more than 1,750 orthotic devices between February 2018 and April 2019, according to a Sept. 11 Justice Department news release. The department alleged that Dr. Patel had no medical relationship with these patients and the referrals were based on brief reviews of their medical charts. 
    • “Medicare and the Federal Employees Health Benefits Program paid more than $400 on average for each device, according to the release. The patient files were provided to Dr. Patel by RediDoc, a telemedicine company whose owners pleaded guilty in 2022 to their roles in a $64 million fraud scheme. 
    • “The claims resolved by Dr. Patel’s settlement are only allegations and there has been no determination of liability, according to the release.”  

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • BioPharma Dive reports
    • The U.S. House of Representatives voted Monday to approve legislation that would restrict U.S. companies from working with five China-based biotechnology firms on clinical development, research and manufacturing, in an attempt to secure the pharmaceutical supply chain.
    • The Biosecure Act passed 306-81 under a procedure used to pass relatively noncontroversial legislation. It was left out of a large Department of Defense bill that cleared the House in June, but may yet need to be included in a Senate version of that defense bill for it win support in that chamber.
    • The legislation would prohibit the federal government from contracting with the five “companies of concern” or any biotech that has a contract with those companies. Drugmakers with current contracts would have until 2032 to allow those deals to expire before being subject to the law.
  • Roll Call and Govexec bring us up to date on FY 2025 appropriations measures under consideration on Capitol Hill.
  • Govexec tells us,
    • “A bipartisan pair of lawmakers on Tuesday filed a discharge petition seeking to force a vote on the House floor on a measure that would eliminate a pair of controversial tax rules that reduce the retirement benefits of some ex-government workers.
    • “Reps. Abigail Spanberger, D-Va., and Garret Graves, R-La., are the lead sponsors of the Social Security Fairness Act (H.R. 82), a measure introduced last year that would eliminate Social Security’s windfall elimination provision and government pension offset.” * * *
    • “Though the bill has widespread support in Congress among both parties—with more than 300 cosponsors in the House alone—the chamber’s leadership has balked at allowing the bill to receive a floor vote. If Spanberger and Graves can secure at least 218 signatures among House lawmakers, they can then force such a vote to take place.”
  • FedWeek reminds us,
    • “September 30 is the end of the “special enrollment period” in which Postal Service retirees eligible for Medicare Part B but not currently enrolled in it may elect that coverage without the standard penalty for enrolling more than three months beyond first eligibility, which typically is on turning age 65.” * * *
    • “Further information on the special enrollment period is here.
    • “Meanwhile, the announcement of plans, coverage terms and premium rates in both the FEHB and the PSHB for 2025 is just ahead. That announcement commonly comes in late September or early October, with fuller information provided just ahead of the open season for enrolling or changing current enrollments, which this year will run November 11-December 9.”
  • Newfront poses a Q&A,
    • “Question: What steps do employers need to take to ensure their coverage meets the ACA affordability standard in 2025?
    • “Short Answer: The 2025 ACA affordability threshold increases to 9.02%. The easiest way to ensure affordability in 2025 is to meet the federal poverty line affordability safe harbor by offering at least one medical plan option (that provides minimum value) for which the monthly employee-share of the premium for employee-only coverage does not exceed $113.20. Otherwise, employers will need to calculate the applicable affordability threshold under one of the other safe harbor approaches, which are based on employee compensation levels.”
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), recently awarded $68 million in grants for suicide prevention and mental health care programs. Addressing the U.S. mental health crisis and preventing suicide are top priorities of the Biden-Harris Administration and part of President Biden’s Unity Agenda.
    • “Every September we recognize Suicide Prevention Month as a time to raise awareness—to remind those struggling that they are not alone and that there is hope. Many people who have experienced suicidal thoughts are alive today because they got help,” said HHS Secretary Xavier Becerra, “The Biden-Harris Administration is deeply committed to expanding and improving suicide prevention in order to save lives. That is why we launched the 988 Suicide & Crisis Lifeline two years ago and why we continue to invest in suicide prevention programs that help save lives across this country.”
  • The Census Bureau posted its report with 2023 statistics on health insurance coverage in the United States based on information collected in the Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
    • “Of the subtypes of health insurance coverage, employment-based insurance was the most common, covering 53.7 percent of the population for some or all of the calendar year, followed by Medicaid (18.9 percent), Medicare (18.9 percent), direct-purchase coverage (10.2 percent), TRICARE (2.6 percent), and VA and CHAMPVA coverage (1.0 percent).
    • “While the private coverage rate was statistically unchanged between 2022 and 2023, the employment-based coverage rate declined by 0.7 percentage points to 53.7 percent in 2023. At the same time, the rate of direct-purchase coverage increased by 0.3 percentage points to 10.2 percent in 2023.”

From the public health and medical research front,

  • Modern Healthcare reports,
    • “Cost, wait times, transportation problems and negative interactions with healthcare professionals are driving U.S. women to delay medical care or skip it altogether, according to a recent Deloitte survey.
    • “Half of the approximately 1,000 women who responded to the consultancy’s 2024 Health Care Consumer Survey said they had forgone care in the past year, compared with 37% of men, Deloitte said in a report Tuesday.
    • “Deloitte paired the results of its survey — which asked a representative sample of roughly 2,000 people in February 2024 about how everyone in the country could have quality medical care — with an analysis of claims data. It found that although women require on average almost 10% more health services than men, they’re about 35% more likely to say they’ve skipped or delayed care.”
  • JD Supra offers “5 Tips for Employers to Prepare for Cold, Flu, and COVID Season.”
  • The Centers for Disease Control and Prevention suggest five actions that communities can take to reduce suicides.
  • Per National Institutes of Health press releases,
    • “A scientific team supported by the National Institutes of Health (NIH) has created a preclinical blood test to identify adults most likely to develop severe respiratory conditions, including chronic obstructive pulmonary disease (COPD). The blood test analyzes 32 proteins that scientists determined accurately predicted an adult with an increased likelihood for requiring medical care for or dying from severe respiratory illness. The risk score was based on lung health data collected from nearly 2,500 U.S. adults over a 30-year period. The findings were published in the American Journal of Respiratory and Critical Care Medicine(link is external).
    • “We are still not ready for this test to be used in practice, but it’s a promising advance,” said James P. Kiley, Ph.D., director of the Division of Lung Diseases at NIH’s National Heart, Lung, and Blood Institute (NHLBI), which funded the study. “It consolidates insights from decades of breathing tests and medical evaluations into a single tool that has the potential to identify patients at risk for severe disease and complications.”
  • and
    • “Providing optional syphilis tests to most people seeking care at a large emergency department led to a dramatic increase in syphilis screening and diagnosis, according to a National Institutes of Health (NIH)-supported study of nearly 300,000 emergency department encounters in Chicago. Most people diagnosed had no symptoms, which suggests that symptom-based testing strategies alone could miss opportunities to diagnose and treat people with syphilis. The results were published today in the journal Open Forum Infectious Diseases.
    • “The Centers for Disease Control and Prevention (CDC) estimates that adult and congenital syphilis cases increased by 80% and 183% respectively between 2018 and 2022. Improved syphilis diagnosis strategies will be essential for reaching populations such as pregnant women and people with limited access to health care. The optimal model for syphilis screening has not been identified, particularly for preventing congenital syphilis. Previous literature supports targeted emergency department syphilis screenings based on clinical factors such as active symptoms or pregnancy. However, the screening criteria used in those models would not capture most people whose syphilis is asymptomatic.”
  • Here is a link to NIH’s Research Matters report covering “Deep brain stimulation for Parkinson’s | Brain-computer interface for speech | Glucose metabolism and Alzheimer’s disease.”
  • Per STAT News,
    • “The first late-stage trial of a GLP-1 drug in young children with obesity showed the treatment helped lower body mass index. But the findings also raise questions about whether obesity medications, some of which are currently approved for teenagers, should also be given to children at such a young age.”
  • Per Medscape
    • “Sustained participation in a community-based structured exercise program is linked to a reduced risk for all-cause hospitalization among older adults, but the benefits varied by gender {favoring women], according to a new study.”
  • Ruh roh. Bloomberg Prognosis lets us know,
    • “I [the reporter] was exposed to Covid at a family get-together in upstate New York last month. Two days later, I woke up feeling awful — sniffles, fatigue and fever. So I swabbed both nostrils with the last Covid test in our cabinet. 
    • “To my great surprise, it was negative, and I went back to sleep. When I tested again two days later, it turned positive in seconds. I started to wonder: Are home Covid tests bad at detecting the latest variants?
    • “The short answer is no, the doctors I spoke with told me. But that answer comes with a big caveat. It turns out the way the immune system interacts with the virus these days means home tests may not turn positive until several days after you get sick.”
  • More ruh roh. The New York Times reports,
    • “Two years before a deadly listeria outbreak [earlier this year], U.S. inspectors warned that conditions at a Boar’s Head plant posed an “imminent threat” to public health, citing extensive rust, deli meats exposed to wet ceilings, green mold and holes in the walls.
    • ‘But the U.S. Agriculture Department did not impose strict measures on the plant, in Jarratt, Va., which could have ranged from a warning letter to a suspension of operations.
    • “Since then, other inspections found that many of the problems persisted, but again, the plant continued to process tons of beef and pork products, including liverwurst.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “More providers are opting out of contracts with Medicare Advantage plans as national insurers reconfigure their networks, leaving patients in limbo.
    • “Medicare Advantage enrollment and profitability surged in recent years as a growing number of seniors sought plans with minimal copays and extra benefits not offered in traditional Medicare. However, Medicare Advantage enrollment growth has slowed and insurance companies’ earnings per member have declined over the past year as insurers grapple with stiffer competition, higher medical costs and utilization, lower reimbursement rates and stricter regulatory oversight.” * * *
    • “This is just the start of insurers’ squeeze on Medicare Advantage markets and provider contracts, the effects of which will grow as Medicare Advantage enrollment is expected to account for about 60% of all Medicare membership by 2030, consultants, analysts and policy experts said.
    • “This is the first year that MA plans have really hammered hospitals, and I think it will get uglier,” industry consultant Paul Keckley said.
    • “Health systems have walked away from in-network agreements or looked to scale up as a buffer and negotiating tool.”
  • and
    • “The American Medical Association released its updated list of Current Procedural Terminology codes for 2025, adding 270 new universal codes used for billing healthcare services and reimbursing providers.
    • “The organization announced 420 updates to its list Tuesday, with several revisions and additions for genetic testing, digital health services like remote patient monitoring and care involving artificial intelligence.”
  • Even more ruh roh. The American Hospital Association News complains,
    • “Hospitals and health systems are seeing significant increases in administrative costs, including due to burdensome practices by commercial insurers that often delay and deny care for patients, according to a new report released Sept. 10 by the AHA. 
    • “Many hospitals and health systems are forced to dedicate staff and clinical resources to appeal and overturn inappropriate denials, which alone can cost billions of dollars every year,” the report notes. 
    • “Among other findings, the report highlights recent data from Strata Decision Technology showing that administrative costs alone account for more than 40% of total expenses hospitals incur in delivering care to patients. In addition, between 2022 and 2023, care denials increased an average of 20.2% and 55.7% for commercial and Medicare Advantage claims, respectively.” 
  • Per Fierce Healthcare,
    • “UnitedHealth Group’s Optum Rx will join its peers in the big three pharmacy benefit managers by pulling Humira from some of its preferred formularies, according to a report from Reuters.
    • “Instead, it will recommend a cheaper biosimilar as the preferred option beginning Jan. 1, 2025, according to the article. Amgen’s Amjevita biosimilar will be among the options.
    • “CVS Health’s Caremark announced similar steps in April, and Cigna’s Express Scripts unit followed suit in August. Prescriptions for Sandoz’s Hyrimoz biosimilar spiked after CVS removed Humira from its major commercial formularies, according to a report in Stat.
    • “Reuters reported that UnitedHealth will continue to offer Humira coverage until the biosimilars are awarded an interchangeable designation from the Food and Drug Administration, which is expected in 2025.”

Friday Factoids

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

From Washington, DC,

  • Govexec tells us,
    • “President Biden formalized his plan to provide civilian federal workers with an average pay increase of 2% next year, in a letter to congressional leaders Friday.
    • “Last March, Biden first announced the pay raise plan as part of his fiscal 2025 budget proposal, marking a significant decrease from previous pay raises of 5.2% in 2024 and 4.7% in 2023. Friday’s announcement confirms that, if implemented, federal employees will see an across-the-board boost of 1.7% to basic pay and an average 0.3% increase to locality pay, a slight departure from the traditional 0.5% of the overall raise figure being set aside for locality adjustments.”
  • and
    • “In accordance with a 2021 Biden administration executive order promoting voting access, OPM in 2022 began requiring agencies to provide federal employees up to four hours of administrative leave to vote in federal, state, local, tribal and territorial elections, which can be used both on Election Day and during early voting. Additionally, agencies must provide an additional four hours of paid leave to employees who serve as election judges or observers.
    • “In a memo to agency heads Thursday, acting OPM Director Rob Shriver reminded agencies of the new voting leave rules.”
  • The Washington Post reports,
    • “Tens of thousands of D.C. residents on Friday will begin receiving letters with good news. That medical debt weighing them down? Poof, it’s gone.
    • “D.C. has deals in place to cancel $42 million in medical debt for 62,000 residents, through a partnership with a nonprofit that has helped cities and states across the country purchase the debt for pennies on the dollar, city officials said.
    • “The program is one way, they say, to ease a financial burden that can have ramifications for jobs, housing and physical and mental health, and disproportionately impacts people of color.
    • “In the District, about 60 percent of the total debt relief will benefit 36,000 residents making $25,000 or less, and 80 percent of residents receiving the relief live in D.C. Zip codes that are majority Black or Latino, city officials said.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention lets us know,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.”
    • “COVID-19
      • “COVID-19 activity is elevated nationally, with continued increases in many areas and early signs of decline in others. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
      • “National vaccination coverage for COVID-19, influenza, and RSV vaccines was low for children and adults for the 2023-24 respiratory illness season. RSV, influenza, and COVID-19 vaccines are available to provide protection during the 2024-25 respiratory illness season.”
  • The University of Minnesota’s CIDRAP adds,
    • “Wastewater SARS-CoV-2 detections are still at the very high level and are highest in the South. Though levels are dropping in the West, they are rising in the South, Midwest, and Northeast, the CDC said.
    • “Meanwhile, wastewater tracking from WastewaterSCAN shows that detections nationally are still at the high level, with no clear trend up or down over the past 3 weeks. The group, however, noted an upward trend in the Midwest.”
  • and
    • “The US Food and Drug Administration (FDA) today announced that it has granted emergency use authorization for Novavax’s updated COVID-19 vaccine. 
    • “Approval of the protein-based vaccine comes about a week after the FDA green-lighted the two updated mRNA vaccines—made by Moderna and Pfizer-BioNTech—which target the KP.2 variant. The Novavax vaccine targets JN.1, the parent of KP.2.
    • “Novavax’s updated vaccine is authorized for people ages 12 and older.” 
  • The New York Times reports,
    • “Wegovy, the popular obesity drug, may have yet another surprising benefit. In a large clinical trial, people taking the drug during the pandemic were less likely to die of Covid-19, researchers reported on Friday.
    • “People on Wegovy still got Covid, and at the same rate as people randomly assigned to take a placebo. But their chances of dying from the infection plunged by 33 percent, the study found. And the protective effect occurred immediately — before participants had lost significant amounts of weight.
    • “In addition, the death rate from all causes was lower among subjects taking Wegovy, a very rare finding in clinical trials of new treatments. The result suggests that lower life expectancy among people with obesity is actually caused by the disease itself, and that it can be improved by treating obesity.
    • “Stunning,” Dr. Jeremy Faust, an emergency room physician at Brigham and Women’s Hospital who wrote an editorial accompanying the study, said of the data. The study was published in The Journal of the American College of Cardiology.”
  • What’s more, STAT News informs us,
    • “Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment.
    • “Researchers combined data on nearly 4,000 patients across four trials who had heart failure with reduced ejection fraction (or HFpEF) and found that 5.4% of those treated with Wegovy experienced cardiovascular-related death or heart failure events, compared with 7.5% of those who received placebo. This translated to a 31% risk reduction.
    • “On heart failure events, defined as hospitalizations or urgent care visits, Wegovy cut the risk by 41%. On cardiovascular-related deaths, it reduced the rate by 18%, but this result was not statistically significant, according to the data, presented Friday at the annual meeting of the European Society of Cardiology and published in the Lancet.”
  • and
    • “An experimental drug from Alnylam Pharmaceuticals substantially cut the risk of death and serious cardiovascular complications among patients with an increasingly diagnosed heart disease, likely teeing up the medicine to be a new option for patients, but one that will face competition from another treatment [from Bridge Bio] also nearing potential approval. 
    • “The full results from the Phase 3 HELIOS-B study, presented here Friday at the European Society of Cardiology’s annual meeting, bolstered the case that the drug, vutrisiran, can offer added benefits for patients with the progressive disease, known as ATTR-CM. Top-line data were released in June.
  • Per FiercePharma,
    • “As a new deadly strain of mpox continues its global spread, Emergent BioSoultion’s smallpox vaccine ACAM2000 has officially joined the ranks of FDA-approved defense measures against the virus.
    • ‘The FDA signed off on the vaccine’s use as an mpox disease preventive in those deemed to be at a high risk for infection.” * * *
    • “Emergent last week linked up with the U.S. government and the World Health Organization (WHO) to donate 50,000 doses of ACAM2000 to the impacted countries the Democratic Republic of Congo, Burundi, Kenya, Rwanda and Uganda through relief organization Direct Relief.” 
  • Here’s food for weekend thought. NBC News reports,
    • “For adults who struggle to get the recommended amount of quality sleep, new research suggests “catching up” those lost hours on the weekends may significantly decrease the risk of heart disease. 
    • “Many people build up “sleep debt” during the week, hoping to make up for it by getting extra hours over the weekend. Sleep debt is the difference between how much quality sleep we need — at least seven hours each night — and how much we actually get, according to the Cleveland Clinic.
    • “In a new analysis being presented Sunday at the European Society of Cardiology Congress in London, cardiovascular researchers based in China found that people who got the most sleep on the weekend were 19% less likely to develop heart disease, compared with a group who slept the fewest extra hours those two days.  
    • “Previous research has shown that not getting enough sleep is associated with poor health. However, there has been little research into how getting extra sleep on the weekend affects the heart.

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “U.S. hospitals reported strong operating margins on growing patient volumes in July, according to new data from analytic solutions firm Strata.
    • “Hospitals’ median year-to-date operating margin climbed from 4.9% in June to 6.5% in July amid increasing demand for both inpatient and outpatient services, according to the report.
    • “Still, expense increases were “sizable” in July, Strata said. Non-labor expenses, including for drugs and supplies, grew at a quicker clip than labor costs year over year.”
  • and
    • “Steward Health Care has signed definitive agreements to sell four Massachusetts hospitals and is close to finalizing agreements to transition two other facilities to new operators, according to documents filed in U.S. federal bankruptcy court Thursday.
    • “Rhode Island-based Lifespan Health System will pay $175 million for the operating licenses, buildings and land associated with St. Anne’s Hospital in Fall River and Morton Hospital in Taunton, according to the purchase agreement. Massachusetts-based Lawrence General Hospital plans to take over both Holy Family Hospital campuses in Methuen and Haverhill for approximately $28 million.
    • “Steward is “continuing to work to finalize” deals to sell St. Elizabeth’s Medical Center and Good Samaritan Medical Center to Boston Medical Center, according to a press release Thursday.”
  • Beckers Hospital Review identifies five major health system mergers yet to close.
  • Per Fierce Healthcare,
    • “Pennsylvania-based insurer and care delivery network Highmark Health recorded $7.4 billion in revenue and $223 million in net income during the second quarter.
    • “Combined with first-quarter results, Highmark’s revenue is 8% higher year over year compared to the first half of 2023.
    • “Executives credited Highmark Health Plans, United Concordia Dental and HM Insurance Group for the robust results.
    • “Highmark Health continues to be financially strong and stable, positioning our organization to adapt and succeed as the healthcare landscape continues to evolve,” said Carl Daley, chief financial officer and treasurer of Highmark Health, in a news release.
    • “After entering southeastern Pennsylvania, with plans to launch Medicare Advantage products in 2025, the health plan’s segment said membership was stronger than anticipated. 
    • “Still, high pharmaceutical costs, utilization trends and Medicaid redeterminations are headwinds to the business.”

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–

From Washington, DC,

  • AARP tells us,
    • “By 2029, more than 4 million people with a Medicare drug plan who do not receive the program’s low-income subsidy will hit the annual [$2000 out of pocket cost] ceiling and see savings when they go to fill their prescriptions, according to a new report published by AARP. * * * [The new cap takes effect January 1, 2025.] * * *
    • “The amount of money each person will save under the new law [the Inflation Reduction Act (IRA)}will vary depending on the medications a person takes and how much they have to pay for them. An estimated 1.4 million adults with a Medicare prescription drug plan who reach the new out-of-pocket cap between 2025 and 2029 are expected to see an average annual savings of $1,000 or more, the AARP report shows. More than 420,000 Medicare Part D enrollees will save $3,000-plus.”
    • This is one on many reasons why FEHB annuitants with Part A or B coverage should consider enrolling in an FEHB Part D EGWP plan or Medicare Advantage with Prescription Drugs (MAPD) plan for 2025. Of course, under OPM’s proposed rule, PSHB annuitants would lose their PSHB drug coverage if they opt out of participating in a Part D EGWP plan or an MAPD for 2025. The FEHBlog does not understand why OPM finds it necessary to create an opt out penalty in view of the generous Part D benefits available next year.
  • Fierce Pharma points out a report finding that the IRA’s provisions intended to juice the sales of biosimilar drugs to hospitals has had limited impact so far.
  • Per a Congressional press release,
    • “House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) today [August 28] is calling on the CEOs of three major Pharmacy Benefit Managers (PBMs)—CVS Caremark, Express Scripts, and Optum Rx—to correct the record for statements made during their appearance before the House Oversight Committee at a hearing titled, “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part III: Transparency and Accountability.”
    • “‘At the House Oversight Committee’s hearing, the PBM chief executives made statements that contradict the Committee’s and the Federal Trade Commission’s findings about the PBMs’ self-benefitting practices that jeopardize patient care, undermine local pharmacies, and raise prescription drug prices. The chief executives for CVS Caremark, Express Scripts, and Optum Rx claimed they do not steer patients to PBM-owned pharmacies. The executives also made claims contradicting the Committee’s and FTC’s findings regarding contract negotiations, contract opt outs, and payments to pharmacies.”
    • The PBM replies are due by September 11, 2024. 
  • Tammy Flanagan, writing in Govexec, fills us in on Social Security survivor benefits.
  • Per a HRSA press release,
    • “Today, the Health Resources and Services Administration (HRSA) announces that for the first time in the 40-year history of the Organ Procurement and Transplantation Network (OPTN), the OPTN Board of Directors—the governing board that develops national organ allocation policy—is now separately incorporated and independent from the Board of long-time OPTN contractor, the United Network for Organ Sharing (UNOS). HRSA has awarded an OPTN Board Support contract to American Institutes for Research to support the newly incorporated OPTN Board of Directors. 
    • “These critical actions to better serve patients by breaking up the monopoly that ran the nation’s organ allocation system are part of the OPTN modernization plan announced by HRSA in March 2023. Prior to these steps, the national body responsible for developing organ allocation policy for the country—the OPTN—and the corporate entity contracted to implement the policy—UNOS—shared the exact same Board of Directors. The new board support contractor will be accountable to HRSA and will organize a special election for a new OPTN Board of Directors with a focus on eliminating conflicts of interest and ensuring that data, evidence, and the voices of clinical leaders, scientific experts, patients, and donor families are driving action and accountability. Moving forward, no member of the OPTN Board can sit on an OPTN vendor’s board of directors.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration announced a final rule that raises the minimum age for certain restrictions on tobacco product sales. These requirements are in line with legislation signed in December 2019 that immediately raised the federal minimum age of sale of tobacco products in the United States from 18 to 21 years of age. Once implemented, the requirements are expected to help decrease underage tobacco sales.  
    • “Beginning Sept. 30, retailers must verify with photo identification the age of anyone under the age of 30 who is trying to purchase tobacco products, including e-cigarettes. Previously, this requirement applied to anyone under the age of 27. It’s important for retailers to request and examine photo IDs to verify age from anyone under 30, regardless of appearance, as research has shown that it is difficult for retailers to accurately determine the age of a customer from appearance alone. 
    • “Additionally, starting Sept. 30, retailers may not sell tobacco products via vending machine in facilities where individuals under 21 are present or permitted to enter at any time. Previously, this prohibition applied to facilities where individuals under 18 were present or permitted to enter at any time. These, and the other changes made by the final rule, aim to maximize the public health impact of the original December 2019 legislation.”
  • The American Hospital Association lets us know,
    • “The U.S. Department of Health and Human Services will not appeal its loss in American Hospital Association v. Becerra. The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, last November sued HHS to bar enforcement of a new rule adopted in guidance by the Office for Civil Rights titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates,” which prevented hospitals and health systems from using standard third-party web technologies that capture IP addresses on key portions of their public-facing webpages. A federal district court in the Northern District of Texas June 20 held that the OCR bulletin’s new rule “was promulgated in clear excess of HHS’s authority under HIPAA.” HHS Aug. 29 officially withdrew its notice of appeal, finalizing the AHA’s victory in this case.”

From the public health and medical research front,

  • The New York Times reports,
    • “The death toll of people who consumed products tainted with listeria that have been linked to Boar’s Head deli meats has risen to nine over the last three weeks, the Centers for Disease Control and Prevention said on Wednesday.
    • “In total, 57 people have been hospitalized because of the bacteria in the outbreak that started in May, the C.D.C. said. 
    • “As a result of the outbreak, the company has recalled millions of pounds of meat. The recall includes about 70 products — including those made from ham, beef and poultry — that were manufactured at its plant in Jarratt, Va. The recall mostly affects products that are sliced at the deli counter, the company said in a statement on its website.
    • “The six new deaths are one person from Florida, one person from Tennessee, one from New York, one from New Mexico and two people from South Carolina, according to health officials.”
    • “The C.D.C. is warning people not to eat the recalled deli meats. Health officials are telling consumers to check their fridges for any recalled Boar’s Head products. (The C.D.C. is telling people to look for “EST. 12612” or “P-12612” inside the USDA mark of inspection on the product labels. Some of the products have sell-by dates that last until October 2024.)”
  • The Wall Street Journal informs us,
    • “Shingles, also called herpes zoster, is a viral infection caused by the reactivation of the virus that also causes chickenpox. The virus remains dormant in the body of anyone who’s ever had chickenpox, and can reactivate at any time.
    • “Most of us think shingles is an old person’s disease and don’t even think about it until our 60s or 70s, especially since the vaccine was long recommended for people aged 60 and over. But the reality is, it can strike at any time, triggered by stress—physical or psychological—and it is often very painful. The good news is it’s often milder at younger ages.
    • “Starting in 1998, shingles rates increased across all ages for nearly two decades, including for those in their 40s, according to Centers for Disease Control and Prevention data. Rates have stabilized somewhat recently but remain higher than the 1990s.” * * *
    • “The CDC doesn’t advise getting the shingles vaccine until you’re 50 or older, at which time people typically have no out-of-pocket cost.
    • “Typically younger people experience milder cases of shingles and are less likely to develop postherpetic neuralgia, or neuropathic pain in the area where you had shingles, which can last months.
    • “But people under 50 who are immunocompromised are more at risk of developing shingles, and the CDC recommends vaccination for those people, provided they are age 18 or over.
    • “It’s unclear how long the shingles vaccine protects against infection. Doctors say it seems to offer good protection for at least up to a decade. Currently the CDC doesn’t recommend getting a booster after the initial two-shot regimen.”  
  • The National Institutes of Health Director writes in her blog,
    • “When someone receives an inactive sugar pill for their pain, the expectation of benefit often leads them to experience some level of pain relief. Researchers have long known that this placebo effect is a very real phenomenon. However, the brain mechanisms underlying the placebo effect for pain have been difficult for researchers to understand.
    • “Now, findings from an intriguing NIH-supported study in mice published in Nature offer insight into how this powerful demonstration of the mind-body connection works in the brain. Furthermore, the researchers identified a previously unknown neural pathway for pain control and suggest that specifically activating this pathway in the brain by other means could one day offer a promising alternative for treating pain more safely and effectively than with current methods, including opioids.” * * *
    • “While the experience of pain is exceedingly complex, and this research is in mice, the researchers expect that these findings will have relevance to people. The next step is to explore the role of activity in this newly discovered pain pathway in humans’ experience of the placebo effect. The hope is that with continued study it may one day be possible to target this brain area using small molecules or neural stimulation as a potentially more effective and safer means to ease pain compared to current methods.”
  • The National Cancer Institute posted its most recent cancer information highlights.
  • Cardiovascular Business points out,
    • “Artificial intelligence (AI) is being used more and more to perform opportunistic screening of computed tomography (CT) scans for a variety of diseases. This is believed to be one way care teams can potentially change the course of preventive care in the near future, and it has been a growing topic at radiology and cardiology conferences in recent years. 
    • “One study study presented at the Society of Cardiovascular CT (SCCT) 2024 meeting led by Brittany Nicole Weber, MD, PhD, director of the Cardio-Rheumatology Clinic at Brigham and Women’s Hospital, is shedding light on the potential of using opportunistic screening in CT scans to detect cardiovascular disease (CVD). This study explored the use of the HealthCCSng AI algorithm developed by Nanox, which was cleared by the FDA in 2021 to identify coronary artery calcium (CAC) in CT scans originally performed for noncardiac reasons. Weber said this strategy could significantly improve early detection and intervention in patients at risk for cardiovascular events. Coronary calcium is a marker of coronary disease on imaging and can be seen in any types of CT scans of the chest. The software can identify and quantify the calcium burden to risk stratify a patient without human intervention.
    • “Patients with autoimmune disorders are at a significantly higher risk for cardiovascular disease, largely due to systemic inflammation. However, many of these patients are not receiving the preventive therapies they need,” Weber explained in an interview with Cardiovascular Business.” 

From the U.S. healthcare business front,

  • Kauffman Hall reports,
    • “Kaufman Hall’s National Hospital Flash Report showed another month of solid performance through the first half of 2024 with a 4.1% operating margin year to date, continuing a trend of stronger performance that began in late 2023. It’s as if a light bulb turned on and has stayed on, setting up 2024 to be a better year than 2023.
    • “Before we declare victory, there are few noteworthy caveats.
      • “First, not all margins are created equally. While the month-over-month median shows improvement, the median change in margin is down, suggesting an uneven distribution of the improvement. About two-thirds of hospitals in the data through 2023 showed no change in operating margin compared to 2019. Many hospitals are running hard but running in place. This means that the improvement in the margin rests on the herculean shoulders of the remaining one third that are doing well—really well, in fact—to drive the national median up.
      • “Second, the Flash report typically reflects only a hospital’s acute care operations. If one were to add in physician enterprises and other similar non-acute care operations that negatively impact performance, margins would decline by about 200 basis points. This would bring our Calendar Year 2023 median of 2.7% in line with FY 2023 rating agency medians, which reported breakeven results.
    • “Notwithstanding these caveats, performance through the first half of 2024 suggests much improved results for full 2024. 
  • Per the Wall Street Journal,
    • “Luxury hotels such as the Waldorf Astoria, renowned for offering impeccable service to clientele, are now catering to an unexpected cadre of VIPs: newborns and their parents.
    • “Postnatal-wellness centers, modeled after ones in Taiwan and Korea, are popping up in American cities, quietly ensconced within tony hotels. For up to $1,500 per night, families leave the hospital and head to a retreat or check in for R & R later. They indulge in recovery, coaching in newborn care and pampering.
    • “Perhaps the most coveted service, however, is the 24-7 nursery staff, affording new parents that elusive treasure: sleep.”
  • Beckers Payer Issues provides seven payer executive answers to the question — what are the most dangerous trends facing payers? For example,
    • “Jen Truscott. Senior Vice President of Aetna Clinical Solutions (Hartford, Conn.):  According to the National Council on Aging, 80% of adults aged 65 and older have two or more chronic conditions. Many older adult patients seek care for health complications long after they have arisen. Care management can improve outcomes for health plan members when these programs are proactive and personalized, yet coordinated care is not utilized to its full extent across the U.S. To combat this, health plans should increase their emphasis on holistic care, effective care management programs and the power of value-based care. Our data show that four in 10 Aetna members changed their behavior — including reducing avoidable emergency room visits, improving medication adherence and choosing more cost-effective sites of care — due to our care management programs proactive outreach.”
  • HR Dive relates,
    • “Three in five U.S. workers reported living paycheck to paycheck, according to PNC Bank’s second annual Financial Wellness in the Workplace Report. And 31% of the more than 1,000 workers surveyed said they would like early access to their paycheck. 
    • “Meanwhile, 78% of the more than 500 U.S. employers surveyed said their workers were financially stressed, up from 71% in 2023. But access to financial planning benefits doubled from the previous year, jumping from 14% to 28%. 
    • “Three out of 10 workers of any generation and 4 out of 10 Generation Z workers with student loan debt report being “at a standstill” while they pay it off.”

Midweek Update

David Ermer–CDC, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Per an HHS press release,
    • “Today, United States Surgeon General Dr. Vivek Murthy released a Surgeon General’s Advisory on the Mental Health and Well-Being of Parents, highlighting the urgent need to better support parents, caregivers, and families to help our communities thrive.
    • “Over the last decade, parents have been consistently more likely to report experiencing high levels of stress compared to other adults. 33% of parents reporting high levels of stress in the past month compared to 20% of other adults. When stress is severe or prolonged, it can have a harmful effect on the mental health of parents and caregivers, which in turn also affects the well- being of the children they raise. Children of parents with mental health conditions may face heightened risks for symptoms of depression and anxiety and for earlier onset, recurrence, and prolonged functional impairment from mental health conditions.” * * *
    • “The work of parenting is essential not only for the health of children but also for the health and future of society. Better supporting parents will require policy changes and expanded community programs that will help ensure parents and caregivers can get paid time off to be with a sick child, secure affordable childcare, access reliable mental health care, and benefit from places and initiatives that support social connection and community.” * * *
    • “You can read the full Advisory here.”
  • Fedweek recounts OPM sub regulatory guidance to carriers who are adding a Postal Service Health Benefits plan to their offerings for 2025.
    • “For the purposes of this [guidance], FEHB plan HRAs, Personal Care Accounts or similar medical funds for qualified medical expenses provided as part of the medical plan, will be referred collectively as OPM HRAs.
    • “OPM is instructing Carriers offering FEHB HDHPs and CDHPs to carry over any OPM HRA credits remaining as of December 31, 2024, for eligible Postal Service enrollees from FEHB plans to PSHB plans as detailed below. This policy is only applicable when an eligible Postal Service enrollee is enrolled in or is automatically enrolled in a PSHB HDHP or CDHP with an OPM HRA offered by the same Carrier as their 2024 FEHB plan. Those FEHB Carriers not offering a PSHB HDHP or CDHP with an OPM HRA will need to inform their Postal Service enrollees that their HRA credits will be forfeited.”

From the public health and medical research front,

  • The CDC’s Advisory Committee on Immunization Practices released recommendations for 2024-25 flu season vaccines today. Here is a link to a summary of those recommendations.
  • Beckers Hospital Review tells us,
    • “GLP-1s reduced mortality and complications from cardiovascular events, according to a study published Aug. 22 in Diabetes, Obesity and Metabolism: A Journal of Pharmacology and Therapeutics.” * * * 
    • “Jeffrey Wessler, MD, a cardiologist with New Hyde Park, N.Y.-based Northwell Health, shared his perspective on GLP-1s and patient adherence with Becker’s earlier in August. 
    • “There are certainly some downstream issues with GLP-1s,” he said. “But for adherence, which is a prime issue for many cardiac medications that work really well in a clinical trial setting, that is not really an issue. People want to take it. It is really transforming how I think about managing an early stage cardiometabolic patient.”
  • BioPharma Dive lets us know, “After an FDA rejection, here’s what’s next in the psychedelics pipeline. By rejecting the first MDMA therapy this month, the FDA signaled to the psychedelic drug field that the road to approval isn’t easy.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Kaiser Permanente’s Risant Health plans to pour well over $1 billion in capital into Cone Health after its acquisition.
    • “The nonprofit pledged a minimum of $1 billion in capital funds to Cone for five years once the deal has closed to support investments in facilities, health equity initiatives and other capital projects, according to financial documents published Tuesday.” * * *
    • “The Cone transaction is expected to close in early 2025, subject to regulatory approval. Cone would operate independently but draw resources and support from Risant. 
    • “Cone reported $164 million in net income in the first nine months of its fiscal 2024, which ends Sept. 30, compared with $104 million in the year-ago period.”
  • STAT News shares the downside of Lilly’s GLP-1 drug announcement yesterday.
    •  “[A] deeper look at the announcement suggests the new offering may not expand access as much as the company indicates. 
    • “Doctors noted that the price of the vials [of Zepbound] will still be out of reach for many patients, and only the starter doses will be offered in the vials, not the higher doses that many patients need to achieve significant weight loss. Additionally, not all patients will be able to pick up vials; they will only be available to patients who are paying for their own medication without insurance and who exclusively order through Lilly’s online portal.
    • “On the same day Lilly launched the vials, it also quietly increased costs for other patients. Before, people who have commercial insurance but don’t have coverage for Zepbound could apply for a savings coupon to get the pens, at whichever dose, for $550 a month, but on Tuesday Lilly raised that price to $650 a month — a move that wasn’t mentioned in the press release.”
  • Per MedTech Dive,
    • “Illumina said Tuesday the Food and Drug Administration has approved its TruSight Oncology (TSO) Comprehensive test.
    • ‘The test uses Illumina’s Nextseq 550Dx sequencing instrument to detect variants in 517 genes using nucleic acids extracted from solid tumor tissue samples.
    • “Illumina also received two companion diagnostic indications for the test, positioning physicians to use TSO Comprehensive to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo cancer drugs.”
  • Financial Advisor IQ informs us,
    • “The expected cost of future health care and medical expenses for a 65-year-old retiring this year has reached an average of $165,000, which is 5% more than in 2023 and more than double what it was in 2002, Fidelity Investments says in a new report.
    • “Fidelity estimates that about 10% of the total outlay will go toward out-of-pocket prescription drug costs, 43% toward Medicare Plan B and Part D premiums, and the remaining 47% to “other medical expenses,” such as co-payments and deductibles. 
    • “The study suggests that many Americans may be unprepared to manage their health in retirement: The average American estimates the total health care costs in retirement to be much less — about $75,000 — Fidelity said it found in a separate report published last year.”

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fedweek lets us know,
    • “Another report to Congress has estimated an annual $1 billion cost to the FEHB program from ineligible persons being covered as family members, a cost that is passed on to both enrollees and the government in the form of higher premiums.
    • “The Congressional Budget Office estimate—agreeing with one last year from the GAO—was done in an analysis of S-4035, which is pending a vote in the full Senate after Congress reconvenes September 9. A counterpart bill, HR-7868, has cleared the House committee level, as well.
    • “The bills would require agencies to verify the eligibility of dependents enrolled in the FEHB when the employee or annuitant starts or changes a dependent’s enrollment; require OPM to audit dependents’ enrollment in the program; and expand fraud risk assessments of the program to include information on ineligible enrollees. * * *
    • “CBO expects that implementing the bill would cause enrollment to decline by about 100,000 people, on average, in each year over the 2025-2034 period. Verifications of eligibility during open season would cause a decline of about 10,000 people, on average, in each year over the same period,” it says.
    • However, that estimate “is subject to significant uncertainty because no similar verification audit of the FEHB program has been undertaken,” it added.
  • FEHBlog sermonette — About ten years ago, OPM added a provision to the FEHB standards contracts providing that the carriers would foot the bill for any family member eligibility audits. OPM never has performed a verification audit due to the FEHB program’s size. However, audits are based on sampling, and surely a sample-based audit of various geographic regions where federal and postal employees live (e.g., Washington, DC and nearby counties, Texas, Florida, etc.) would have told OPM whether or not it has a family member eligibility problem.
  • OPM does have a more glaring enrollment problem because OPM separately reports enrollment and premiums to carriers. Consequently, carriers, which carry the insurance risk, do not have the opportunity to confirm that enrollees in their records (based on OPM’s data) are paying the proper premiums for selected self only or other than self only coverage. What is the sense of nailing down family member coverage when no one knows whether the enrollee is paying the proper or any premium?
  • For close to twenty years, CMS, which implements HIPAA’s electronic standards, has made available an electronic enrollment roster transaction known as the HIPAA 820, which would allow FEHB carriers to reconcile enrollment and premiums at the individual level using computer systems. That’s a massive gap in internal controls that needs to be corrected without further delay, in the FEHBlog’s humble opinion. All that OPM has to do is tell the payroll offices to use the HIPAA 820. End of sermonette.
  • Per a company press release,
    • Maximus has been awarded a $20 million contract from the Office of Personnel Management (OPM) to serve as the Contact Center Services Provider for the agency’s new Postal Service Health Benefits Program. This program will provide health insurance to eligible Postal Service employees, annuitants, and their eligible family members starting in 2025.
    • Maximus will be leading the customer support effort to answer calls and emails for OPM’s new, enhanced customer service platform dedicated to assisting eligible individuals access health insurance benefits. Maximus will leverage offerings from its Total Experience Management (TXM) solution, including state-of-the-art telephony, customer relationship management, and call quality reporting tools to provide best-in-class customer service.
    • “The Postal Service Health Benefits Program is an invaluable benefit for the U.S. Postal Service workforce, and Maximus is uniquely positioned to develop this new contact center and Customer Experience (CX) approach based on more than 30 years of experience working with OPM,” said Larry Reagan, Senior Managing Director, Federal Civilian Market, Maximus. “Our senior team has vast experience standing up new customer service programs at scale for federal agencies to deliver a range of services, including disaster recovery, education, and health benefit services.”
  • Healthcare Dive tells us,
    • “An expensive drug for weight loss could become one of Medicare’s costliest medications, even if the majority of patients are ineligible for coverage, according to a study published on Monday in the Annals of Internal Medicine.
    • “The analysis found 3.6 million people are highly likely to be eligible for semaglutide like Wegovy, a GLP-1 that’s effective at treating obesity. More liberal definitions of eligibility could increase that number to 15.2 million patients.
    • “If all newly eligible patients received semaglutide, spending in Medicare’s Part D prescription drug benefit could increase by $34 billion to $145 billion each year, according to the study. Even if the government narrowly defined eligibility, federal spending on the medicine could still exceed $10 billion annually.”
  • Medscape adds,
    • “Now that the U.S. government has negotiated prices for some Medicare program drugs effective in 2026, Wall Street analysts are betting on a 2027 list that will include Novo Nordisk’s blockbuster Ozempic for diabetes and have a limited impact on Big Pharma. [FEHBlog note — Wegovy is the weight loss version of Ozempic. Medicare by statute does not cover weight loss drugs.]
    • “Other possible 2027 candidates include Pfizer’s cancer drugs Ibrance and Xtandi, GSK’s asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta, Teva’s Huntington’s disease treatment Austedo and Abbvie’s irritable bowel syndrome drug Linzess, according to five analysts as well as researchers and company executives.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS) announced more than $558 million in funding to improve maternal health, building on the Biden-Harris Administration’s commitment to reducing the nation’s high maternal mortality rate through the White House Blueprint for Addressing the Maternal Health Crisis. The Health Resources and Services Administration (HRSA), an agency of HHS, is awarding more than $440 million in funding to expand voluntary, evidence-based maternal, infant, and early childhood home visiting services for eligible families across the country. In addition, the Centers for Disease Control and Prevention (CDC) announced a new investment of $118.5 million, over five years, to 46 states, six territories, and freely associated states to continue building the public health infrastructure to better identify and prevent pregnancy-related deaths.” * * *
    • “For a complete list of Maternal, Infant, and Early Childhood Home Visiting Program awardees, visit https://mchb.hrsa.gov/programs-impact/programs/home-visiting/maternal-infant-early-childhood-home-visiting-miechv-program/fy24-awards.”
  • A Federal News Network Data Dive tells us, “USPS improves on-time delivery in delay ‘hotspots’, but faces year-end challenges. Postal experts say USPS improvements to on-time delivery are needed, and must continue, for Congress to allow these plans to keep moving forward.”

From the public health and medical research front,

  • Beckers Hospital Review reports on an August 23, 2024, press conference that leaders of the CDC, HHS and FDA held to discuss the upcoming respiratory virus season.
  • The American Medical Association informs us about what doctors wish their patients knew about lung cancer screening.
    • “Lung cancer causes about 160,000 U.S. deaths a year, which is greater than the toll of the next three most common cancers—colon, breast and prostate—combined. Yet only about 30% of lung cancer cases are diagnosed early. Most patients are diagnosed at a far less treatable, later stage of the disease. And with about 20% of lung cancer deaths preventable, evidence-based screening recommendations for high-risk patients offers the best hope to catch the disease early and provide the best chance for effective treatment.”
  • Medscape looks into how old is too old to undergo a screening colonoscopy.
  • The National Institutes of Health (NIH) issued a medical research report this afternoon.
  • Per an NIH press release,
    • “So-called low-intensity blood stem cell transplants, which use milder conditioning agents than standard stem cell transplants, do not appear to damage the lungs and may help improve lung function in some patients with sickle cell disease (SCD), according to a three-year study of adults who underwent the procedure at the National Institutes of Health (NIH).
    • “Damage to lung tissue and worsened lung function is a major complication and leading cause of death in people with sickle cell disease, a debilitating blood disorder. The new study, published today in the Annals of the American Thoracic Society, helps answer whether less intensive types of transplants, which tend to be better tolerated by many adults, by themselves either cause or promote further harm to the lungs.
    • “By using a low-intensity blood stem cell transplant for sickle cell disease, we may be able to stop the cycle of lung injury and prevent continued damage,” said study lead Parker Ruhl, M.D., an associate research physician and pulmonologist at NIH. “Without the ongoing injury, it’s possible that healing of lung tissue might occur, and this finding should help reassure adults living with sickle cell disease who are considering whether to have a low-intensity stem cell transplant procedure that their lung health will not be compromised by the transplant.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group’s philanthropic arm has released a new deep dive into maternal and infant health, underscoring socioeconomic disparities in women’s health.
    • “The study found that American Indian/Alaska Native, Black and Hawaiian/Pacific Islander women had maternal mortality rates that were between 2.5 and 4.5 times higher than other ethnic groups. Severe maternal morbidity was, in 2020, two times higher among Black mothers than white mothers, and 1.5 times higher among Black mothers compared to Hispanic mothers.
    • “There were also racial disparities identified in low-birth weight, according to the study. Low birth weight rates were 2.1 times higher among babies born to Black mothers compared to infants born to white mothers.
    • “There were some bright spots in the data, however. Between 2008 and 2011 and 2018 to 2021, there were improvements to infant mortality rates among some racial groups. The study found improvements of 15% among infants born to white mothers, 12% among babies born to Black mothers and 9% for babies born to Hispanic mothers.
    • “Lisa Saul, M.D., national medical director of maternal child health at UnitedHealthcare, said in a press release that analyses like this are critical to developing targeted solutions to key challenges.”
  • Beckers Hospital Review informs us,
    • “After about 18 months since the FDA greenlit preventive COVID-19 medication Pemgarda for emergency use, the agency has tweaked its decision. 
    • “The agency has narrowed the medicine’s emergency use authorization. It is now OK to use when “the combined national frequencies of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%,” the FDA said in an Aug. 26 letter to the drug’s maker, Invivyd. 
    • “Pemgarda (pemivibart) is authorized for the pre-exposure prophylaxis of COVID-19 in some adults and children older than 12. Eligible patients are those who have a moderate-to-severe immune compromise and are unlikely to have an adequate response to a COVID-19 vaccine.
    • “Early data indicate that COVID-19 variant KP.3.1.1 may have substantially reduced susceptibility to Pemgarda. As of Aug. 17, the variant accounted for 36.8% of COVID-19 infections, according to CDC data. If this percentage surpasses 90%, Pemgarda’s emergency use authorization could be revoked.”
  • Per MedTech Dive,
    • “Insulet received U.S. clearance Monday for its Omnipod 5 system for Type 2 diabetes management — a first for the industry — making automated insulin delivery to control blood sugar available to millions of additional people living with diabetes.
    • “The system’s tubeless pump automatically adjusts insulin levels based on data from a continuous glucose monitor (CGM), replacing manual dosing. Since its approval for Type 1 patients in 2022, Omnipod 5 has become the most prescribed insulin pump in the U.S. and has more than 250,000 users globally, Insulet Chief Medical Officer Trang Ly said in an interview with MedTech Dive.
    • “Ly discussed the product’s launch for Type 2 diabetes patients, partnerships with other device makers and how the company is working to win over doctors reluctant to prescribe insulin pump therapy.”
    • Check out the interview.

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • Eli Lilly is now distributing a single-dose vial form of its popular weight loss medicine Zepbound that it says people with a valid prescription can obtain for a cash price that’s 50% less than the current cost of other GLP-1 drugs for obesity.
    • The single-dose vials are available through Lilly’s online service LillyDirect as a self-pay option, which could appeal to people without employer insurance coverage or those who don’t qualify for the company’s savings card program, Lilly said.
    • A four-week supply of Zepbound single-dose vials at a 2.5 milligram dose will cost $399, while the 5 milligram dose will cost $549. While those prices are well below the $1,060 monthly list price of Zepbound’s injector pen formulation, they’re not far from the drug’s estimated net price after accounting for rebates and discounts to insurers, according to a client note from Evercore ISI analyst Umer Raffat.
  • Per Healthcare Dive,
    • “Pfizer on Tuesday launched a direct-to-consumer service it claims will help people schedule telehealth appointments, fill prescriptions and access savings programs for the company’s migraine, COVID-19 or influenza medicines.
    • “Dubbed PfizerForAll, the online service will provide resources for people looking to obtain treatment for migraine, COVID or the flu, or to schedule vaccinations for diseases like pneumococcal pneumonia and respiratory syncytial virus.
    • “The platform aims to “streamline the path for those seeking better health,” Aamir Malik, Pfizer’s chief U.S. commercial officer, said in a statement. The company said it is working with partners UpScriptHealth, Alto Pharmacy and Instacart.”
  • MedCity News notes,
    • “Waltz Health, a digital health company focused on prescription drugs, launched Waltz Connect on Monday. The new solution aims to reduce the cost of specialty medications.
    • “Chicago-based Waltz Health was founded in 2021 and serves payers and pharmacies. It has a product called Marketplace Search, which allows users to search for any prescription and see the range of prices available at their pharmacy. It also works with health plans to bring its marketplace solutions into their pharmacy benefit.
    • “The company’s Waltz Connect product supports payers and focuses on specialty medications. When a specialty prescription is submitted for a member, Waltz Connect redirects it to the most suitable pharmacy, regardless of the pharmacy’s network status with the payer. This routing is based on the member’s benefit design and several factors, including price, turnaround time, fulfillment accuracy, member experience and adherence rates. These factors can be customized by drug class or specific drugs. Health plans also receive information on the member’s condition, prescription onboarding, the selected pharmacy’s contact information, expected fulfillment turnaround time and the number of refills.”
  • and discusses the pros and cons of artificial intelligence for health insurers. “With so much hinging on technology that is the subject of so much hype, it is important to understand where AI actually helps at present — and where it most definitely does not.”
  • Beckers Hospital Review points out,
    • “Boston-based Mass General Brigham’s Home Hospital program has expanded to 70 beds, making it the largest home hospital in the country, according to a news release shared with Becker’s.
    • “The capacity increase was accompanied by expanded clinical care teams and the creation of dedicated roles within Home Hospital created. The system has also incorporated medical assistants into the care model and expanded the ambulance services to meet growing demand.
    • “Since its launch in January 2022, the program has had more than 4,000 patient admissions and saved more than 20,000 acute care hospital-based bed days. The average patient stays in a Home Hospital bed is 5 days.”
  • and
    • Where Steward’s 31 hospitals stand
      • From seeking Chapter 11 protection on May 6 to sharing plans to close four of its hospitals across Massachusetts and Ohio that would result in a combined 2,187 layoffs, Dallas-based Steward Health Care has experienced a great deal of turbulence over the last year.
      • As the for-profit health system continues to push back bid deadlines and sale hearings for many of its hospitals, the status of each facility remains in question, leaving community members, healthcare workers and state and local lawmakers concerned.
      • Below, Becker’s has provided a list of Steward’s 31 hospitals by state, per the health system’s website, and the most recent information regarding each facility. [FEHBlog note — Beckers plans to keep this list updated.]
  • Per Fierce Healthcare,
    • “Aetna will cover intrauterine insemination as a medical benefit for eligible plans, a move the insurer called a “landmark policy change.” 
    • “Intrauterine insemination, or IUI, is usually only covered if employers offer a separate fertility benefit plan, according to an Aug. 26 news release from Aetna. 
    • “The change will apply to fully insured Aetna commercial plans. * * *
    • “Expanding IUI coverage is yet another demonstration of Aetna’s commitment to women’s health across all communities, including LGBTQ+ and unpartnered people,” Cathy Moffitt, MD, Aetna’s chief medical officer, said in the news release. “This industry-leading policy change is a stake in the ground, reflecting Aetna’s support of all who need to use this benefit as a preliminary step in building their family.”
  • Medscape adds,
    • “In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
    • “The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
    • :A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee-based firm that provides navigation and coordination services to oncology practices and insurers.”

Friday Factoids

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

From Washington, DC

  • Fedweek posted an August update on implementation of the Postal Service Health Benefits Program (“PSHBP”).
    • “At least one major insurance carrier, FEP Blue Cross Blue Shield, has already sent letters to current participants letting them know that a plan similar to their current plan has been conditionally approved and stating that they’ll share more details on the PSHB benefits and premiums “later this year, in time for Open Season”
    • “The USPS reports new plan details will be available as of September 15, and will be sent out via hard mail in the weeks that follow.
    • “The USPS says that participants will receive a “crosswalk letter” in late October showing the new plan into which the USPS intends to enroll them. If you agree, there’s nothing to do: you’ll be enrolled in that plan.”
  • The FEHB enrollees who may be in for a surprise are those who currently participate in an FEHB plan that is not participating in the PSHBP. In October, OPM will enroll those folks in the lowest cost nationwide plan option that is not a high deductible plan or charge associate member dues. Those folks will have an opportunity to change plans during the regular federal benefits open season. The FEHBlog expects that the PSHBP navigators will be lending a helping hand to those folks, particularly those eligible for Medicare.
  • The Postal Times reminds us,
    • “If you were an annuitant entitled to Medicare Part A (typically at age 65) as of Jan. 1, 2024, and did not enroll in Medicare Part B, you and your covered eligible family members may be able to participate in a one-time PSHB Special Enrollment Period (SEP) for Medicare Part B from April 1 through Sept. 30, 2024. Those who choose to enroll during the SEP will have the late enrollment penalty paid for by the Postal Service. Eligibility letters were sent to annuitants and eligible family members in March 2024. If you have misplaced the notification letter mailed to you or believe that you are eligible to participate in the PSHB SEP and did not receive a notification letter, call the PSHB Navigator toll-free help line at 833-712-PSHB (7742) or email retirementbenefits@usps.gov.”
  • Speaking of the Postal Service, Federal News Network lets us know,
    • “The Postal Service is planning to roll out several changes next year to drive down its operating costs and ensure more reliable service to most of its customers.
    • “USPS says the next step of its network modernization plan, which will happen next year, is to get mail and packages to their destination in fewer trips between mail processing plants and post offices.
    • “The agency expects these adjustments will not only help it squeeze $3 billion of annual overhead costs out of its operations, but enable faster delivery of mail and packages to customers within 50 miles of the agency’s largest regional mail processing plants.
    • “For customers outside that 50-mile radius, however, USPS, anticipates ”some mail and packages will experience a longer service standard,”  according to a filing submitted to its regulator on Thursday. 
    • “In those cases, mail and packages in those more rural areas will remain in transit for about a day longer before reaching their final destination.
    • “USPS, however, told the Postal Regulatory Commission that these changes will have a “net positive impact” on service for first-class mail, packages and marketing mail, and will be delivered “at the same level of service or faster,” for most customers.”
  • The American Hospital News expresses distress because
    • Johnson & Johnson announced Aug. 23 that it would be fundamentally changing the way it makes 340B pricing available for two of its most popular products, Stelara and Xarelto. Starting Oct. 15, J&J will require all disproportionate share hospitals participating in the 340B Drug Pricing Program to purchase these drugs at full price and submit data to J&J. Upon verification of the drug’s 340B status, DSHs would receive a rebate for the discounted 340B price.
    • Last week, the AHA contacted the Health Resources and Services Administration for more information as soon as it was made aware that J&J was considering these actions. HRSA notified the AHA today that it has informed J&J that its rebate model is inconsistent with the 340B statute and that this model has not been approved by the Secretary of the Department of Health and Human Services. HRSA further informed the AHA that it has told J&J that HRSA will take appropriate action as warranted.

From the public health and medical research front,

  • The Centers for Disease Control and Prevention (“CDC”) announced today,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in many areas. * * * “Nationally, the wastewater viral activity level for COVID-19 is currently very high.“
    • “COVID-19
      • Many areas of the country are continuing to experience increases in COVID-19 activity, though other areas are experiencing declines in COVID-19 activity following increases this summer. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations remain elevated, particularly among adults 65+ and children under 2 years. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • RSV
      • “Nationally, RSV activity remains low.
    • Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • “High-dose (HD) and adjuvanted influenza vaccines offered the best protection for people aged 65 years and older against symptoms and hospitalization during the 2022-23 flu season, concludes a real-world study published this week in Clinical Infectious Diseases.
    • “High-dose flu vaccines contain four times the standard dose (SD), while adjuvanted vaccines contain an extra immune-boosting ingredient. In 2022, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended high-dose, adjuvanted, or recombinant (cell-based) vaccines over SD vaccines for older adults, who are at elevated risk for severe disease and flu-related hospitalization and death.”
  • The New York Times reports,
    • “After a years long lull thanks to Covid-19 precautions like isolation and distancing, whooping cough cases are now climbing back to levels seen before the pandemic, according to data from the Centers for Disease Control and Prevention.
    • “So far this year, there have been 10,865 cases of whooping cough, or pertussis, nationwide. That’s more than triple the number of cases documented by this time last year, and is also higher than what was seen at this time in 2019. Doctors say these estimates are most likely an undercount, as many people may not realize they have whooping cough and therefore are never tested.
    • “The pandemic delayed routine childhood vaccinations, including those that protect against whooping cough, and led to fewer pregnant women getting vaccinated. Those factors have likely contributed to the current uptick in cases, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center. Pertussis cases tend to peak in the summer and fall, he said, and so it’s particularly critical to be aware of the disease now, as children head back to school and respiratory illnesses pick up.”
  • Bloomberg tells us,
    • “US teenagers aren’t getting vaccinated against HPV at the same pace as before the Covid pandemic, a trend that could imperil efforts to control a common cause of cervical and other cancers.
    • “Immunization rates have stagnated for kids aged 13 to 17 for the past two years, according to data that the Centers for Disease Control and Prevention published Thursday. Meanwhile, routine shots for diseases like tetanus and meningitis have returned to pre-pandemic levels, according to the CDC survey, which analyzed results from nearly 17,000 teenagers.
    • “The trend could cause alarm among public health officials. Each year, human papillomavirus causes more than 21,000 cases of cancer in women and about 16,000 in men. * * *
    • “This is the only vaccine I know of that prevents cancer,” said Sunil Sood, a pediatrician who specializes in infectious disease at Northwell Health in New York. “Putting it like that has been known to make a difference” to parents who might be resistant to having their children vaccinated, he said.”
  • Per MedCity News, “Side Effects are Limiting GLP-1 Drug Efficacy: How Can Personalization Offer a Solution? By integrating digitization and machine learning, there is an opportunity to deliver personalized care to all patients and scale precision dosing with minimal physician involvement, maximizing the effectiveness and accessibility of these drugs.”
    • “There is a clear and unique opportunity to apply dose optimization to GLP-1s to improve real-world persistence and adherence, supporting patients to continue treatment long enough to experience the full benefits, such as positive cardiovascular outcomes. We know clinicians are seeing the need for this and are already making necessary interventions but struggling still to find a scalable solution. Pairing drugs with proven digital solutions, within a single label, can facilitate personalization across the GLP-1 market, improving the effectiveness of these drugs and diminishing side effects. Not only can pharma leverage this approach to deliver best-in-class clinical and commercial outcomes, but it also promises to revolutionize disease management, enhancing patient safety and outcomes by tailoring treatment to individual needs, truly bringing precision care to all.”
  • Pulmonary Advisor notes, “About two-thirds of adults who smoked wanted to quit in 2022, although fewer than 10% were successful, according to study findings published in the Morbidity and Mortality Weekly Report.

From the U.S. healthcare business front,

  • EBRI offers an Issues Brief concerning “Trends in Self Insured Health Coverage; ERISA at 50.”
  • Per MedTech Dive,
    • “Stryker said Thursday it has agreed to acquire Vertos Medical, an Aliso Viejo, California-based company whose minimally invasive technology treats chronic lower back pain, for an undisclosed sum.
    • “The Vertos procedure, which can be performed in an outpatient setting, is designed to provide pain relief for patients with lumbar spinal stenosis by restoring space in the spinal canal and reducing nerve compression.
    • “This acquisition strengthens our minimally invasive pain management portfolio with differentiated treatments and expands our reach across ambulatory surgery centers,” Andy Pierce, head of Stryker’s medical and surgical equipment and neurotechnology business, said in a statement.”

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, FDA, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Govexec reports,
    • “Republican leaders on the House Homeland Security Committee want to know what the Biden administration is doing about Havana syndrome, mysterious brain injuries that became public in 2016 after State Department officials in Cuba’s capital city were affected. 
    • “We are deeply alarmed that these incidents continue to take place here and abroad, and that there has been little to no explanation from the administration as to who or what has caused these phenomena,” wrote full committee Chairman Mark E. Green, R-Tenn., and Counterterrorism, Law Enforcement and Intelligence Subcommittee Chairman August Pfluger, R-Texas, in a letter to National Security Advisor Jake Sullivan Tuesday. 
    • “The brain injuries, referred to as anomalous health incidents, include symptoms of headaches, pain, nausea, disequilibrium and hearing loss. Additional reports of similar symptoms later emerged from federal employees in other countries such as China, Russia, Vietnam, Colombia and various parts of Europe.
    • “Green and Pfluger, who have held numerous hearings and briefings on this matter, requested a committee briefing from the National Security Council. They also urged the administration to prioritize expending unused funds allocated to provide care for AHI victims and to fully implement the HAVANA Act, a 2021 law that authorizes payments to impacted intelligence, diplomatic and other governmental personnel.”  
  • Reuters informs us,
    • “The U.S. Navy has received more than 546,500 claims for compensation from people impacted by decades of contaminated water at Marine Corps Base Camp Lejeune in North Carolina, a new court filing shows, putting it squarely among the largest injury cases of all time.
    • “That number may fluctuate up or down by a few thousand, the government said in the filing, opens new tab. The U.S. Navy is reviewing additional claims received up to the Aug. 10 deadline and removing claims that are found to be duplicates.
    • “The number of administrative claims filed with the U.S. Navy – a step claimants must have taken by the Aug. 10 deadline to receive compensation for injuries they attribute to the water – surpasses the nearly 400,000 lawsuits filed over 3M Co’s military-issue earplugs, which is regarded as the largest multidistrict litigation in history.”
  • The Chair and Ranking Member of the House Education and Labor Committee sent a letter to the Assistant Secretary of Labor who handles ERISA matters. The letter asks the Assistant Secretary about the Department’s efforts to “address troubling practices of certain group health plan service providers.”
  • Federal News Network interviews Colleen Heller-Stein, the first career fed to lead the CHCO Council.

From the public health and medical research front,

  • Per a Food and Drug Administration press release,
    • “Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.”
  • Beckers Hospital Review offers three notes on the FDA action.
  • The Wall Street Journal adds,
    • “The two shots [Pfizer and Moderna] will be available to anyone over 6 months of age, a move that comes as Covid hospitalizations continue to climb and remain higher than they were at this time last year, according to data from the Centers for Disease Control and Prevention. 
    • “Doctors say everyone who is eligible should get a shot. But older people who have skipped other recent vaccine updates should especially consider it. 
    • “I saw a lot of people in the hospital who got a lot of shots in the beginning of the pandemic and then didn’t get any shots for a year or two years,” said Dr. Peter Chin-Hong, a professor of medicine at University of California-San Francisco and an infectious-disease specialist. * * *
    • “Unless you’re very concerned about acquiring Covid right now, my recommendation would be to get it in September or October,” said Dr. William Schaffner, a professor of preventive medicine at the Vanderbilt University School of Medicine. “That will provide the best protection throughout the winter season.” 
    • “The CDC recommends people get one of the new vaccines by the end of October. Both will be available at local clinics and pharmacies.” 
  • The American Hospital Association News lets us know,
    • “The Food and Drug Administration Aug. 22 granted emergency use authorization for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-19 Dual Test is authorized for use by laboratories to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens. The Flowflex Plus COVID-19 and Flu A/B Home Test is authorized for home use for people aged two and older.” 
  • The American Medical Association lets us know what doctors wish their patients knew about pre-eclampsia.
  • MedPage Today suggests that “Europe Offers Clues for Solving America’s Maternal Mortality Crisis.”
  • The Brown and Brown consulting group makes an urgent call for employers worldwide to become more aware of the risk of suicide among their employees and engage in suicide prevention efforts.
  • Beckers Hospital Review shares patient safety goals at top rated U.S. hospitals.
  • Per HealthDay, “The overdose-reversing drug naloxone can help save the lives of people whose hearts have stopped due to an opioid OD, a new study shows.”
  • The Institute for Clinical and Economic Review’s “independent appraisal committee voted that current evidence is not adequate to demonstrate net health benefits for imetelstat added to best supportive care when compared to best supportive care alone; treatment [for the treatment of anemia in patients with low-to-intermediate risk myelodysplastic syndrome] would meet common thresholds of cost effectiveness if priced between $94,800 to $113,000 per year, therapy currently priced at approximately $365,000 per year.”

From the U.S. healthcare business front,

  • Modern Healthcare tells us,
    • A federal judge’s ruling this week that blocked the Federal Trade Commission’s near-total ban on noncompete clauses in employment contracts is creating more uncertainty for healthcare employers as they await the agency’s next move.
    • Federal regulators have cracked down on what they view as anticompetitive behavior in recent years, particularly in healthcare. The FTC’s nationwide noncompete ban will no longer take effect Sept. 4, but that doesn’t mean the issue is resolved.
    • Noncompete agreements are common in the healthcare industry. Many organizations, including hospitals, health systems, physician groups, insurance companies and pharmacy benefit managers, use the agreements in employment contracts to protect business interests and ensure competitors don’t obtain proprietary information.” * * *
    • “The FTC has said Tuesday’s ruling does not remove its authority to challenge noncompete bans on a case-by-case basis.”
    • “There’s not going to be any certainty on this for a while,” said Jason Weber, an employment attorney at law firm Polsinelli.” * * *
    • “Polsinelli’s Weber said companies should try to reduce confusion by educating employees on the ruling and emphasizing that noncompete obligations remain in effect.
    • Weber said employers also have a good opportunity to assess their existing agreements and reevaluate whether noncompete clauses are essential to protecting their businesses. For example, employers could use less-restrictive options such as non-solicitation covenants, he said.” 
  • Beckers Payer Issues lists,
    • “Several insurers [that] landed on Forbes’ annual ranking of the “Best Employers by State.” 
    • “The 2024 ranking, published Aug. 20, sorts 1,294 top employers in the U.S. by state. Forbes surveyed more than 160,000 employees at companies with more than 500 people. Respondents evaluated their current employers, employers they’d worked with in the past two years and organizations they knew through their industry. 
    • “Insurers appeared among the top employers in most states, except for Alaska, Delaware, Washington, D.C., Idaho, Maine, Mississippi, Montana, Oklahoma, Rhode Island, Vermont and Wyoming.” 
  • Medscape relates,
    • “Most physicians oppose the way standardized relative value units (RVUs) are used to determine performance and compensation, according to Medscape’s 2024 Physicians and RVUs Report. About 6 in 10 survey respondents were unhappy with how RVUs affected them financially, while 7 in “10 said RVUs were poor measures of productivity.
    • The report analyzed 2024 survey data from 1005 practicing physicians who earn RVUs.” * * *
    • “[O]ver half of clinicians said alternatives to the RVU system would be more effective, and 77% suggested including qualitative data.” 
  • Per Fierce Healthcare,
    • “A Thursday afternoon [bankruptcy] sale hearing scheduled for several Steward Health Care hospitals was shelved in favor of an amended bankruptcy court itinerary hashing out multiple disputes related to the company’s pending deals for hospitals in Florida and Pennsylvania.”  ***
    • “Though not the focus on Thursday’s hearing, Steward’s counsel also opened the hearing with quick updates on developments in Massachusetts and Ohio.
    • “For the former, Candace Arthur, who represents Steward, said that the company’s estate is “very close to the finish line and still fully engaged in mediation” regarding the deal announced last week.
    • “As for Ohio, where closure notices were issued yesterday for two Steward hospitals, Arthur described those filings as “a deadline thing.”

Midweek Update

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Beckers Payer Issues explains how members of Congress receive their health benefit coverage. Of course, since 2014, the answer has been and remains the DC Affordable Care Act exchange. However, retired members of Congress often are eligible for federal pension which includes FEHB coverage with the full government contribution.
  • Federal News Network lets us know,
    • “The Office of Personnel Management is starting to see the light at the end of the tunnel on its never-ending journey to modernize its retirement systems.
    • “A pilot to test out a new online retirement application platform is showing promise with several federal payroll providers.
    • “Guy Cavallo, OPM’s chief information officer, said the pilot includes the Agriculture Department’s National Finance Center and several others to reduce both the amount of paper needed and the error rate in processing retirement applications.
      Guy Cavallo is the CIO at the Office of Personnel Management.
    • “We believe doing the online checking will help really reduce that back and forth that often is needed. We’re also rebuilding the way calculations are done, and we’re implementing a digital file system so that we can stop dealing with millions and millions of pages of paper to be part of retirement,” Cavallo said in an interview with Federal News Network. “It’s going to take many years for us to do this, but by taking the heart of that, we’re improving the way somebody starts to retirement. We’re making sure the calculation service is correct, and then we’re working to get rid of paper versions and move to digital. Those are our first three building blocks.
    • “Cavallo said the goal of the test is to test out the technology and the process changes and continually improve them. He said there is no specific time frame for how long the pilot will last.”
  • Per Beckers Hospital Review,
    • “The FDA is building a post-market surveillance program for medical devices.
    • “The agency will look for medical device-related safety issues reported in EHRs, billing claims and pharmacy data, according to a U.S. Government Accountability Office report released Aug. 15.
    • “The program will begin surveillance of two medical devices by December, with plans to increase the number of devices under investigation each year over the next five years. 
    • “There were more than 1.7 million injuries, and 83,000 deaths linked to medical device safety issues over a 10-year period, according to FDA data from 2018, the report said.”

From the public health and medical research front,

  • The Wall Street Journal reports
    • “The average age of hip- and knee-replacement patients is getting younger.” * * *
    • “For patients ages 45 to 64, there was a 211% increase in inpatient hip replacements and a 240% increase in inpatient knee replacements between 2000 and 2017, according to data from the U.S. Department of Health and Human Services’ Agency for Healthcare Research and Quality. (Records after 2017 are less accurate due to changes in Medicare coding.)
    • “There was also an increase in joint replacements for patients ages 65 to 84, but the rise wasn’t as steep.
    • “This tracking doesn’t include the growing share of replacements that are outpatient surgeries, which allow patients to go home the same day as their procedure. More than a million hip and knee replacement surgeries are performed in the U.S. every year.”
  • The New York Time warns us,
    • “Without a sharp pivot in state and federal policies, the bird flu virus that has bedeviled American farms is likely to find a firm foothold among dairy cattle, scientists are warning.
    • “And that means bird flu may soon pose a permanent threat to other animals and to people.
    • “So far, this virus, H5N1, does not easily infect humans, and the risk to the public remains low. But the longer the virus circulates in cattle, the more chances it gains to acquire the mutations necessary to set off an influenza pandemic.
    • “I think the window is closing on our ability to contain the outbreak,” said Dr. Krutika Kuppalli, an infectious-disease physician who worked at the World Health Organization until April.”
  • Here’s a link to the CDC’s website on the disease.
  • STAT News tells us,
    • “Lack of research into miscarriage in the U.S. — its prevalence, its causes, and how best to treat people who’ve experienced pregnancy loss — has helped to reinforce what has long been a culture of silence and shame around miscarriage. That knowledge gap means that people who miscarry, and miscarry repeatedly, like Hanson, aren’t given the emotional support they need at a time when they are most vulnerable. Equally important, they aren’t given the medical treatment, screening, and support from the health care system that might help them avert future miscarriages. And research into the possible reasons for recurrent pregnancy loss has been limited and siloed, several experts told STAT.”  * * *
    • “When Carol Gilbert, an assistant professor at the University of Nebraska Medical Center College of Public Health, examined CDC data for her 2021 Ph.D. dissertation on perinatal periods of risk, she realized that she needed more complete data for losses before 20 weeks. For public health researchers like Gilbert, incomplete data prevents them from making accurate comparisons between states.When she examined the data, she understood why the CDC doesn’t publish statistics on fetal losses before 20 weeks of gestation. 
    • The individual case data on pregnancy losses are collected by hospitals, assembled by states, and then forwarded to the CDC. But a trifecta of quality problems may explain why the CDC does not publish what data it does receive on losses before 20 weeks of gestation. First, laws regarding the gestational age at which fetal losses need to be reported vary across states. The second problem Gilbert found was that states were inconsistent in their reporting, failing to follow their own laws. This was especially true for fetal deaths between 20 and 24 weeks. 
    • “The third problem was that not all states fill forms completely, leaving out data elements like birthweight and basic maternal characteristics. Some of this is inevitable because it is difficult to weigh fetal tissue in the early stage of pregnancy loss. A CDC spokesperson told STAT that “information regarding early pregnancy losses before 20 weeks’ gestation, including ectopic pregnancies and miscarriages, is challenging to obtain as these outcomes are not routinely reported to CDC.”
  • and
    • “Rachel Gross wants to clear up misconceptions about children and Covid-19. A pediatrician and population health researcher, she recalls a time four years ago when people didn’t think children could even contract the disease. Then, after accepting kids’ vulnerability to the virus, it was thought only adults could suffer from the myriad symptoms that persist or crop up post-infection, collectively known as long Covid.
    • “Now that it’s clear kids can also develop long Covid, Gross wants to correct assumptions that the condition looks the same in adults as in children, no matter their age. In new research published Wednesday in JAMA, Gross and the RECOVER-Pediatrics Consortium report that school-age children and adolescents experience similar long Covid symptoms across multiple organ systems, but those symptoms cluster in ways that vary depending on their age while diverging to some degree from the pattern seen in adults.” * * *
    • “Gross told STAT the study’s purpose was to learn how to identify children experiencing long Covid and how these symptoms change over time. “Then we will be able to better understand the question we really want to know: Why is this happening?”
  • Medscape adds, “Severe COVID-19 was associated with elevated risks for depression and serious mental illness months after infection, especially among unvaccinated people, a cohort study involving more than 18 million individuals in the U.K. found.”

From the U.S. healthcare business front,

  • Per Beckers Hospital Review,
    • “Renton, Wash.-based Providence posted an operating loss of $123 million in the second quarter of 2024, a $79 million improvement from the $202 million loss the 51-hospital system posted during the same period last year.
    • “Operating revenues increased by 6% compared to the same period last year, according to an Aug. 21 Providence news release shared with Becker’s. Operating expenses increased 5% for the three months ended June 30. 
    • “Providence saw higher volumes in the second quarter of 2024, according to the release. Inpatient admissions and case mix adjusted admissions were both up 5% compared to the same period last year. 
    • “Despite ongoing headwinds, our strategies for renewal and recovery are driving positive results, and we remain focused on continued improvement in 2024,” Providence CFO Greg Hoffman said in the release.” 
  • and
    • “Dallas-based Steward Health Care plans to close Trumbull Regional Medical Center and Hillside Rehabilitation Hospital, both in Warren, Ohio, on or around Sept. 20 after the facilities failed to attract qualified buyers, the health system said in an Aug. 21 statement shared with Becker’s.
    • “Steward, which sought Chapter 11 protection May 6, shared that the “regrettable but unavoidable situation” has occurred due to its “significant cash constraints.”
    • “We remain hopeful we can find an alternative solution that would keep the hospitals open and preserve the jobs of our dedicated team members,” the statement said. “We want to help save this hospital and will continue to work with qualified bidders during this process.”

Weekend Update

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

From Washington, DC,

  • The House of Representatives and the Senate remain on their August recess until September 9.
  • Roll Call reported on August 14,
    • “New Jersey Democratic Gov. Phil Murphy intends to appoint his former chief of staff, George Helmy, to fill the Senate seat that Sen. Bob Menendez will vacate next week, multiple New Jersey media outlets reported Wednesday evening, citing sources.
    • “Helmy, who has most recently worked as executive vice president and head of external affairs for RWJBarnabas Health, will serve until the end of the 118th Congress. The seat for the full term starting in January will be filled by the winner of the November election between Rep. Andy Kim, the Democratic nominee, and Republican Curtis Bashaw.”
  • On August 16, the Congressional Budget Office released to the House Oversight and Accountability Committee a report on H.R. 7868, the FEHB Protection Act.
    • The problematic aspect of the bill is that it focuses on tightening up oversight of family member eligibility when OPM does not give FEHB plans the information to confirm that plan enrollees are paying the proper premium or any premium for their coverage, which creates a yawning gap in internal controls. OPM can cure this problem by implementing the HIPAA 820 enrollment roster transaction.

From the public health and medical research front,

  • Fortune Well identifies where COVID has been spiking in the U.S. this summer.
    • “In the four-week period ended Aug. 10, the national test positivity rate was 15.6%. During that time, five states in the South-Central U.S. saw the highest test positivity, 21%. These states collectively make up the CDC’s Region 6:
      • Arkansas
      • Louisiana
      • New Mexico
      • Oklahoma
      • Texas
    • “States in Region 9—Arizona, California, Hawaii, and Nevada—had the next-highest four-week positivity rate, 18.8%. Ten other states across two Midwestern regions were also above the national average. No state—as well as the District of Columbia, Puerto Rico, and the Virgin Islands—had a positivity rate below 10%.”
  • The Washington Post lets us know,
    • “The Centers for Disease Control and Prevention is warning clinicians to be on the lookout for a viral disease that is spread by small flies and some types of mosquitoes and that causes sudden fever, severe headaches and chills.
    • “Cases of Oropouche virus disease have been climbing in South America and the Caribbean in the past two years and turned deadly for the first time this year.
    • “The CDC advisory issued Friday recommends that pregnant people reconsider nonessential travel to Cuba, which reported its first confirmed case in June.”
  • and
    • “Though appendectomies have been the gold standard of care since before the turn of the 20th century, doctors have been treating appendicitis with antibiotics since the 1950s, as soon as they became available — a “dark secret” in the surgery world, says David R. Flum, professor of surgery and director of the Surgical Outcomes Research Center at the University of Washington. A 1959 paper detailed the use of antibiotics to treat nearly 500 people (a mix of adults and children) with appendicitis. They were — and still are — often used in people whose appendicitis is so advanced that surgery risks spreading the infection further. The military relied on antibiotics for service members who got appendicitis while in inaccessible locations, like submarines.
    • “But the treatment didn’t get wider attention until the late 1990s and early 2000s, Flum says, when researchers began to collect data on how often antibiotics don’t work and found that failure was not as common as they thought.
    • “Then came two large, randomized trials in adults. In the first, published in 2015, 257 adults received an antibiotic treatment. Seventy of those patients, or 27 percent, had to have an appendectomy within one year. But the rest were fine.
    • “A second, larger study of 1,552 adults had similar results: Twenty-nine percent of the 776 people who received antibiotics underwent surgery within 90 days; 4 percent of people in the antibiotics group had serious adverse events, compared with 3 percent in the appendectomy group. The New England Journal of Medicine published the results in 2020. The same year, the American College of Surgeons added nonoperative management as an option in its guidelines for treating appendicitis.
    • “It wasn’t a slam dunk, but the studies showed that antibiotics could be a good choice.”
  • The New York Times discusses “The Painkiller Used for Just About Anything. In huge numbers, older people are taking gabapentin for a variety of conditions, including itching, alcohol dependence and sciatica.”
    • “It’s crazy how many [off label] indications it’s used for,” said Dr. Michael Steinman, a geriatrician at the University of California, San Francisco, and a co-director of the U.S. Deprescribing Research Network. “It’s become a we-don’t-know-what-else-to-do drug.”
    • “What has fueled this multipurpose popularity? “The history of gabapentin is really a history of uses getting ahead of the evidence,” said Dr. Joseph Ross, an internist and health policy researcher at Yale School of Medicine.” * * *
    • Dr. Steinman called it a “sticky” drug. He was an author of a 2022 study on older adults who were prescribed gabapentin after surgery, most commonly hip and knee replacements. One in five refilled the prescription more than three months later, when “presumably their surgical pain has long since resolved,” he said.
    • As older patients seek to find relief from chronic pain, “we don’t have a lot of great options,” Dr. Steinman said of health care providers. Prescribers try to avoid opioids, and nonsteroidal anti-inflammatories like ibuprofen are recommended only for short-term use.
    • Some find relief from medical cannabis, topical medications like creams and patches, and non-pharmacological approaches such as acupuncture, therapeutic massage and exercise.
    • “Often the single best thing I can do for patients with pain is to get them to physical therapy,” Dr. Steinman added.

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Orlando Health has offered to buy Steward Health Care’s three “Space Coast” Florida properties, including three hospitals and a medical practice, for $439 million, according to a court document filed Wednesday.
    • “Bankrupt Steward Health Care and Orlando Health have entered into a binding asset purchase agreement to sell Rockledge Regional Medical Center, Melbourne Regional Medical Center, Sebastian River Medical Center. The proposed deal also includes Steward Medical Group Practices in East Central Florida.
    • “According to the court document, filed in U.S. bankruptcy court in the southern district of Texas, Steward designated Orlando Health a “stalking horse bidder,” which is the first to negotiate a purchase agreement with a debtor in bankruptcy. The bidder sets a minimum price and protects the debtor from low bids.
    • “The purchase agreement for Steward’s northern Florida assets is for $439.42 million in cash, according to the court document.
    • “Orlando Health’s bid will be subject to higher or better-qualified bids received by August 26, at which time a bankruptcy court-approved auction may occur, according to a press release from Steward Health Care.”
  • The Wall Street Journal adds
    • “Steward Health Care System was in such dire straits before its bankruptcy that its hospital administrators scrounged each week to find cash and supplies to keep their facilities running. 
    • “While it was losing hundreds of millions of dollars a year, Steward paid at least $250 million to its chief executive officer, Dr. Ralph de la Torre, and to his other companies during the four years he was the hospital chain’s majority owner.
    • “Steward filed for bankruptcy in May, becoming one of the biggest hospital failures in decades.” * * *
    • “The Senate Committee on Health, Education, Labor and Pensions in a bipartisan vote authorized an investigation and subpoenaed de la Torre to testify at a Sept. 12 hearing.”