Friday Factoids

Government Contracting

Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Government Contracting, Medical / Rx research, Medicare, Mental health care, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The battle to empower the federal government to negotiate lower prices for Medicare enrollees was years in the making. The war has just begun. 
    • “After years of opposition from the pharmaceutical industry and lawsuits seeking to halt the law that led to the new prices, resistance paled and legal efforts failed. The talks settled into a sometimes testy back and forth: hundreds of pages of paperwork, offers and rejected counteroffers, then rounds of meetings in windowless rooms with strict rules on how many people could attend.
    • During the meetings, many manufacturers lowered counter offers while federal officials moved up from their initial offers, said Meena Seshamani, director of the Center for Medicare and a deputy administrator of Medicare’s parent agency, the Centers for Medicare and Medicaid Services.” * * *
    • “Round two is just around the corner. 
    • “Companies and officials are already preparing for negotiations over more drugs that could take a bigger bite out of high drug costs, and possibly their bottom lines. Next up are prices of 15 more drugs the government will identify by Feb 1. 
    • “The two sides are also fighting over how the talks should work. Among the drug industry’s demands: clarity on how CMS determines the price of a drug. Drug companies are also fighting the agency’s potential changes for next year, including possibly cutting back the number of in-person meetings to fewer than three.”
  • Federal News Network informs us,
    • “Scores of House Democrats are calling on the Postal Service to adopt stricter workplace protections for extreme heat.
    • “The 77 House Democrats are calling on USPS to “immediately implement” the standards in the workplace heat rule the Occupational Safety and Health Administration (OSHA) proposed last month.
    • “Proactively implementing this rule would save lives by ensuring that your workforce is protected with the most up-to-date heat safety standards,” the lawmakers wrote in a letter to Postmaster General Louis DeJoy.
    • “The proposed rule, if finalized, would be the nation’s first-ever federal heat rule.”
  • and
    • “Federal employees on official travel will soon enjoy another bump in reimbursable travel costs, as the General Services Administration has increased per diem rates for lodging and meals.
    • “Starting Oct. 1, the reimbursable daily limit will rise to $178, from $166 last year. This increase marks the third consecutive year feds saw lodging rates go up, while rates for meals and incidental expenses (M&IE) last went up in 2022.
    • “The standard per diem lodging rate within the continental United States (CONUS) went up from $107 to $110, while the rates for M&IE increased from a range of $59 to $79, to a range of $68 to $92.
    • ‘Agencies [and experience rated FEHB contractors] use per diem rates to reimburse employees for lodging and M&IE during official travel. Even with inflation growth in the U.S. now losing steam, the continued increase in per diem rates reflect the persistent rise in overall costs that Americans face across the board.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention tells us,
    • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is elevated in most areas.
    • 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
  • Minnesota CIDRAP adds,
    • “Nationally, wastewater detections of SARS-CoV-2 are at the very high level for the second straight week. The highest levels are still in the West and South, followed by the Midwest and the Northeast. The CDC’s latest update, however, shows downward trends from high levels in the South and Midwest.” 
  • The Washington Post reports,
    • “Federal authorities are preparing to approve updated coronavirus vaccines targeting the latest virus variants late next week, a move that could make shots available before Labor Day, according to a federal health official and a person familiar with the plans who spoke on the condition of anonymity to discuss a confidential process.
    • “The mRNA shots manufactured by Pfizer-BioNTech and Moderna designed to target the KP.2 variant can hit the market within days of approval by the Food and Drug Administration. A third protein-based vaccine made by Novavax, preferred by people who are cautious about mRNA vaccines or who have had bad reactions to them, will probably take longer to be approved and will be distributed in subsequent weeks, according to the federal health official.
    • “Consumers should be able to start getting shots at pharmacies within a week after approval and at doctor’s offices soon after.”
  • and
    • “The Food and Drug Administration on Friday authorized the first at-home [, over the counter,] syphilis test amid surging cases of the bacterial infection and calls from federal health officials for innovative strategies to detect the disease.
    • “The manufacturer, NowDiagnostics, anticipates the 15-minute test called First to Know, being available in pharmacies, major retail stores and online as early as September. FDA staff hailed the new product as an advancement in testing for sexually transmitted illnesses but noted that an additional test by a health-care provider is needed to confirm a positive result.
    • “Syphilis was nearly eliminated in the 1990s, but rates have since soared to a 70-year high. Between 2018 and 2022, cases rose nearly 80 percent, according to the most recent data from the Centers for Disease Control and Prevention.
  • Per BioPharma Dive,
    • “Pfizer and BioNTech on Friday said a combination flu and COVID-19 shot they’ve been developing met one of its main goals in a Phase 3 trial but missed another, leaving the vaccine’s future in doubt. 
    • ‘The study tested Pfizer and BioNTech’s vaccine against separately administered, marketed COVID and flu shots in more than 8,000 people between the ages of 18 and 64. While the combination vaccine spurred a comparable immune response against COVID and influenza A, it didn’t meet that mark against the “B” strain of the flu.  
    • “As a result, two companies are “evaluating adjustments” that would improve the vaccine’s performance against influenza B while discussing next steps with health authorities.”
  • STAT News adds,
    • “The National Institutes of Health said Thursday that an antiviral often used to treat mpox did not resolve patients’ symptoms faster than placebo in a randomized trial.
    • “The results are notable because the drug, tecovirimat, has rarely been studied clinically for mpox, despite its wide use during the 2022 and 2023 outbreaks in the U.S. and Europe.”  
  • The American Medical Association shares “Top health tips sleep medicine physicians want you to know.”
  • Per Healio,
    • “Among a select group of women with uterine factor infertility, uterus transplant was feasible and associated with a high live birth rate after successful graft survival, data from a case series show.
    • “In an analysis of the Dallas Uterus Transplant Study (DUETS), researchers also found that although adverse events were common, including complications requiring surgical intervention, infants born to women who received a uterine transplant had no congenital abnormalities or developmental delays, though follow-up of the cohort is ongoing.
    • “We show that uterus transplantation is not only feasible and safe, but also associated with a success rate that is comparable with and even favorable to other infertility treatments,” Liza Johannesson, MD, PhD, of the Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center, told Healio. “[What is] important is that the children born after uterus transplant are healthy and developing normally.”
  • Medscape offers an interview with a Harvard medical professor about preventing dementia.
    • “Hello. This is Dr JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a new report on the preventability of dementia that is both exciting and paradigm-shifting. The new study, published in The Lancet by the Lancet Commission on Dementia, estimates that close to 50% of cases of dementia worldwide can be prevented or delayed by improving 14 modifiable risk factors.”

From the U.S. healthcare business front,

  • MedCity News discusses the future of retail healthcare.
  • Behavioral Health Business lists the 40 fastest growing behavioral health companies in the U.S.
  • Per Reuters,
    • “Older Americans are having little success getting prescriptions for weight-loss drug Wegovy covered by Medicare despite the federal healthcare program’s decision to pay for patients with obesity at risk of heart disease, according to their doctors.
    • “In interviews with Reuters, seven obesity and heart disease specialists from various parts of the United States said their prescriptions for the Novo Nordisk (NOVOb.CO), opens new tab drug have been denied repeatedly by the healthcare companies that administer Medicare drug benefits, with some prescriptions approved only following an appeal for each application.”
  • Per Fierce Healthcare,
    • “Massachusetts’ governor has announced that deals in principle have been reached for Steward Health Care’s four remaining hospitals in Massachusetts.
    • “Should the deals be finalized, Lawrence General Hospital will operate both campuses of Holy Family in Haverhill and Methuen. Lifespan would take over operations of Morton Hospital and Saint Anne’s Hospital. Boston Medical Center will take over operations of Good Samaritan Medical Center.
    • “Boston Medical Center also intends to operate Saint Elizabeth’s down the line. The state is first taking control of the hospital through eminent domain, according to an announcement from the governor’s office.”

Friday Factoids

David Ermer–CDC, Government Contracting, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The New York Times reports,
    • A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart.
    • The tiny Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions. * * *
    • “When reporting on outsize bleeding rates related to the Impella devices, Dr. Desai, of Yale, has also noted that its payments are far higher than the balloon pump, creating an urgent need for rigorous studies of how to best treat patients.
    • “You hate to think this is part of that story, but I think we would be naïve to think that that couldn’t be part of the story,” he said.”
  • The Labor Department’s Office of Federal Contractor Compliance Programs announced,
    • “Contractors that meet certain jurisdictional thresholds have an obligation to develop and maintain written Affirmative Action Programs (AAPs).
    • “The Contractor Portal is OFCCP’s platform where covered federal contractors and subcontractors must certify, on an annual basis, whether they are meeting their requirement to develop and maintain annual AAPs. The portal allows multiple users from individual organizations to register, manage records, and certify each establishment and/or functional/business unit, as applicable.
    • “Beginning April 1, 2024, federal contractors will be able to certify the status of their AAPs for each establishment and/or functional/business unit, as applicable. The deadline for certifying compliance is July 1, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 9 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high or very high activity the previous week. This week no jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.   
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.  
    • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, remains low.
    • “Reported on Friday, March 29th, 2024.“
  • The Hill informs us,
    • “Tuberculosis rates in the U.S. rose by 16 percent in 2023, marking the third year that cases went up following nearly 30 years of decline.
    • In the most recent Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC), the number of TB cases in 2023 totaled at 9,615, a jump of 1,295 over 2022.
    • “The last time annual TB cases in the U.S. were higher than 9,500 was in 2012, when 9,906 were detected. As the report noted, TB cases had declined for 27 years, reaching a record low of 7,171 in 2020 before creeping back up.
    • “While there is a vaccine for tuberculosis, the CDC notes that it’s mostly used in countries with a high prevalence of TB and isn’t recommended for use in the U.S. due to low risk of infection.
    • “In a January report to Congress, the United States Agency for International Development attributed the rise in TB cases globally to the disruptions brought on by the COVID-19 pandemic.
    • “After two years of COVID-19-related disruptions to TB prevention, diagnosis, and treatment efforts, 2023 had the highest number of people diagnosed and started on treatment since the beginning of the disease’s global monitoring in 1995 that affected access to and provision of health services – due in part to concerted efforts to recover from the pandemic’s devastating global impact,” the agency said.”
  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention issued a health advisory Thursday [March 27] about a rise in rare but severe forms of meningococcal infections. These bacterial infections can cause potentially life-threatening inflammation of the membranes surrounding the brain and spinal cord.
    • “The CDC says 422 cases were reported in 2023, the highest annual number seen since 2014. Of the 94 cases with known outcomes, 17 died. Since March 25, 143 cases have been reported to the CDC — 62 more cases than what was seen over the same time period in 2023.
    • “The spike is notable in part because infections are disproportionately affecting people ages 30 to 60, as well as African American individuals and those with HIV. Typically, infants younger than 1, teenagers and young adults ages 16 to 23 as well as individuals older than 85 have a higher risk of contracting meningococcal disease.
    • “The agency says health-care experts should increase monitoring for meningitis symptoms, and the public should take steps to prevent its spread.
    • “We’re not recommending any unusual precautions,” said Lucy McNamara, an epidemiologist in the meningitis and vaccine-preventable diseases branch at the CDC.
    • “We would like for the general public to be aware of the symptoms of meningococcal disease and to contact their health-care provider if they or members of their family have those symptoms,” she said, adding that officials also “want to make sure that they’re up to date for meningococcal vaccinations.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb’s cancer pill Krazati helped people with a certain kind of non-small cell lung cancer live longer without their disease progressing and shrank tumors at a higher rate than those given chemotherapy, the company said Thursday.
    • “The data could help Bristol Myers persuade the Food and Drug Administration to convert Krazati’s conditional approval into a full clearance, potentially giving it an advantage over Amgen’s rival drug Lumakras. Amgen’s bid to gain confirmatory approval was unsuccessful, and the company has four years to complete another trial testing its pill.
    • “Both Krazati and Lumakras target tumors harboring a mutation in a gene called KRAS — a long-sought goal of drugmakers. While their uptake is currently modest, both Bristol Myers and Amgen are working to expand their use into earlier lines of treatment and other types of cancer.”

From the U.S. healthcare business front,

  • CNN calls our attention to the fact
    • “For the first time, women in the US can walk into a store and buy a supply of birth control pills right off the shelf, without the need for a prescription or health insurance.
    • “Opill, the first oral contraceptive approved by the US Food and Drug Administration for over-the-counter use, has arrived at most stores in certain retail pharmacy chainssuch as CVS, Walgreens and Walmart.
    • “The product is “is now available at CVS.com and through the CVS Pharmacy app and is arriving at more than 7,500 CVS Pharmacy stores in the coming weeks,”spokesperson Matt Blanchette said in an email. “For added privacy and convenience, customers will be able to choose same-day delivery or buy online and pick-up in store.”
    • “Walgreens began offering Opill in late March, spokesperson Samantha Stansberry said.
    • “The product “will be available at Walgreens nationwide in the family planning aisle and behind the pharmacy,” Stansberry said in an email. “Customers can also purchase the product online for 30-minute Pickup, 1-hour Delivery, or ship to home.”
    • “At Walmart, “it is currently available on walmart.com and will be in stores in early April,” spokesperson Tricia Moriarty said in an email.”
  • Kaufmann Hall issued its March National Hospital Flash Report on March 27.
    • “Key Takeaways
      • “Margins this month were at 3.96%, continuing a strong start to 2024. However, data
        this month do not reflect the full impact of the Change Healthcare outage, which
        began February 21st.
      • “Gross revenue continues to rise at a faster rate than net revenue, highlighting payer
        mix changes. Bad debt and charity care have also risen over the last few years.
      • “Revenue growth is primarily being driven from the outpatient setting. There
        continues to be a decline in inpatient revenue and increase in outpatient revenue.”
  • STAT News lets us know,
    • “Diabetes drugs are too expensive in the U.S., and insulin is infamously six to 13 timesmore expensive here than in comparable high-income countries. And blockbuster GLP-1 drugs, too, could be a lot less expensive, according to an investigationpublished this week in JAMA Network Open, with a simple change: robust generic competition.
    • “The study, led by Melissa Barber, a Yale postdoctoral fellow, and conducted in collaboration with Doctors Without Borders, a nonprofit medical organization working in low-resource and emergency settings, found that making a generic vial of insulin could cost $61 to $111 per year — 97% less than than the current market price in the U.S., based on an estimate that factors in a 10% to 50% profit margin. * * *
    • “Findings for the cost of making GLP-1 biosimilars were along the same lines. Researchers calculated that the cost of producing a patient’s monthly supply of a GLP-1 drug would range from $0.75 to $72.50; currently, Ozempic costs about $1,000 a month in the U.S, $155 in Canada, and less than $60 in Germany, according to a statement by Sen. Bernie Sanders, who cited the study as evidence of pharmaceutical overpricing and called on Novo Nordisk to lower the price of Ozempic.”
  • and
    • “The staff of the Institute for Clinical and Economic Review, or ICER, are known as the nerds of the drug industry: bespectacled killjoys who emerge a few times a year to scold drugmakers for pricing their latest cancer or MS advance far beyond reason.
    • “But last year, they sat down and concluded a forthcoming treatment was worth up to $3.9 million — more than any medicine in history, more than a 45-year supply of Humira, the autoimmune drug often held up as an emblem of America’s runaway drug spending. 
    • “It was a testament to the power of a new class of gene therapies to deliver something pharma so rarely does: Genuine cures. The treatment, approved last week as Lenmeldy, may allow some babies born with an ultra-rare neurodegenerative disease called metachromatic leukodystrophy, or MLD, to grow up and live essentially normal lives.
    • “David Rind, ICER’s chief medical officer, compared Lenmeldy to Zolgensma, a gene therapy approved in 2019 for spinal muscular atrophy that the nonprofit estimated could be worth up to $2.1 million. * * *
    • “Lenmeldy, Rind said, is still overpriced. Orchard Therapeutics, Lenmeldy’s developer, is tacking on an additional $325,000, for a $4.25 million total. But its price falls closer to those estimates, as a percentage, than the vast majority of medicines it reviews.”
  • Healthcare Dive brings us “inside CVS Health’s push to transform customer experience. The transformation, led by Deloitte Digital, focused on increasing customer feedback to identify pervasive issues and closing the loop on customer inquiries.”
  • Beckers Payer Issues relates,
    • “UnitedHealth Group has named CFO John Rex as president of the company. 
    • “Mr. Rex is taking over the president role from COO Dirk McMahon, who plans to retire. UnitedHealth Group has not announced a successor in the COO role. Mr. McMahon spent 20 years in various leadership positions at UnitedHealth Group, and was named president and COO in 2021.  
    • “According to a March 28 regulatory filing, Mr. Rex will assume the president role April 1, in addition to his current position as CFO.” 

Happy Leap Day!

David Ermer–CDC, Congress, Cybersecurity, Government Contracting, Medicare, Mental health care, Obesity, SDOH, U.S. Healthcare–
Photo by Joe Caione on Unsplash

From Washington, DC,

  • Politico reports,
    • “The Senate approved a stopgap funding bill Thursday night for President Joe Biden’s signature, thwarting a partial government shutdown on Saturday and buying more time to finalize half a dozen spending bills that congressional leaders aim to pass next week.
    • “Congress now officially has until March 8 to clear that initial six-bill bundle, which leaders struck a deal on earlier this week. But they’re still working on an agreement to fund the rest of the government, including the military and some of the biggest domestic programs, before a second deadline on March 22. The upper chamber cleared the measure in a 77-13 vote, following votes on four Republican amendments that were defeated on the floor.”
  • The U.S. Preventive Services Task Force posted for public comment a draft research plan concerning Primary Care Interventions for Tobacco and Nicotine Use Prevention and Cessation in Children and Adolescents. The comment period ends on March 27, 2024.
  • The Labor Department’s Office of Federal Contract Compliance Programs created an updated website for the “The Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA) [which] is a law that prohibits federal contractors and subcontractors from discriminating in employment against protected veterans and requires employers take affirmative action to recruit, hire, promote, and retain these individuals.”
  • Yesterday, the Politico Pulse posted a story on a December 2022 Government Accountability Office report, released January 9, 2023, criticizing OPM’s internal controls over FEHB family member eligibility. Here is a link to the GAO’s website for the report which offers August 2023 updates on OPM’s efforts to implement GAO’s recommendations. Here’s are FEHBlog recommendations for GAO and OPM:
    • Family member eligibility hinges on the enrollee’s eligibility. OPM needs to have the payroll offices implement the HIPAA 820 enrollment roster electronic transaction which allows carriers to reconcile premiums to actual headcount. Use of the HIPAA 820 will be a huge step toward confirming the accuracy of family member eligibility and the 50% of FEHB enrollees who have self only coverage.
    • The Politico article suggests that the high cost of a family member eligibility audit discourages OPM from implementing one for the FEHBP. Auditors do their work based on samples. Arrange for a family member eligibility audit using statistically appropriate samples which will disclose, at the very least, the scope of the problem.

From the U.S. public health and medical research front,

  • The New York Times reports,
    • “Long Covid may lead to measurable cognitive decline, especially in the ability to remember, reason and plan, a large new studysuggests.
    • “Cognitive testing of nearly 113,000 people in England found that those with persistent post-Covid symptoms scored the equivalent of 6 I.Q. points lower than people who had never been infected with the coronavirus, according to the study, published Wednesday in The New England Journal of Medicine.
    • “People who had been infected and no longer had symptoms also scored slightly lower than people who had never been infected, by the equivalent of 3 I.Q. points, even if they were ill for only a short time.
    • “The differences in cognitive scores were relatively small, and neurological experts cautioned that the results did not imply that being infected with the coronavirus or developing long Covid caused profound deficits in thinking and function. But the experts said the findings are important because they provide numerical evidence for the brain fog, focus and memory problems that afflict many people with long Covid.”
  • and
    • “Alcohol-related deaths surged in the United States by nearly 30 percent in recent years, with roughly 500 Americans dying each day in 2021, according to a new study published by the Centers for Disease Control and Prevention.
    • “The study chronicled a sustained spike in drinking during the Covid pandemic that continued to rise after the shock of the lockdowns of 2020. The incidence of alcohol-related deaths was higher in men, but among women the death rate shot up at a quicker pace.
    • “I think the results of this research are really alarming,” said Dr. Michael Siegel, who is a professor of public health at Tufts University School of Medicine and was not involved in the study. “It shows that there’s been a truly substantial increase in alcohol-related deaths over the last six years.”
  • and
    • “The 2022 outbreak of mpox, previously known as monkeypox, was curbed in large part by drastic changes in behavior among gay and bisexual men, and not by vaccination, according to a new analysis published on Thursday in the journal Cell.
    • “Public health response to outbreaks often relies heavily on vaccines and treatments, but that underestimates the importance of other measures, said Miguel Paredes, lead author of the new study and an epidemiologist at the Fred Hutchinson Cancer Center in Seattle.
    • “Although the Food and Drug Administration approved a vaccinefor mpox in 2019, getting enough doses produced and into arms proved challenging for many months after the outbreak began. Vaccines for new pathogens are likely to take even longer.
    • “The new analysis suggests an alternative. Alerting high-risk communities allowed individuals to alter their behavior, such as reducing the number of partners, and led to a sharp decrease in transmission, Mr. Paredes said. In North America, the outbreak began petering out in August 2022, when less than 8 percent of high-risk individuals had been vaccinated.
    • “Public health messaging can “be really powerful to control epidemics, even as we’re waiting for things like vaccines to come,” he said.”
  • Roll Call adds,
    • “Cases of measles are rising across the country and seem to be striking counties at random, but experts say there is one thing the public health system can do to turn the tide, and that’s to stem the post-pandemic vaccine lag and get parents to vaccinate their kids.
    • “General vaccination rates, including measles vaccination, declined during the COVID-19 pandemic, as people had less access to health care and kids were unable to access in-school vaccine clinics.
    • “That, combined with a new wave of vaccine skepticism and anti-vaccine sentiment has contributed to a wave of unvaccinated kids falling sick with the once-eradicated virus.”
  • MedPage Today tells us,
    • “The benefits of vaccination against respiratory syncytial virus (RSV) for adults ages 60 and older probably outweigh the small risk of vaccine-related Guillain-Barré syndrome (GBS), the CDC’s Advisory Committee on Immunization Practices (ACIP) reaffirmed.
    • “In a presentation on the second day of the ACIP’s 2-day meeting, Amadea Britton, MD, of the CDC’s RSV adult vaccination work group in Atlanta, noted that a small number of cases of Guillain-Barre syndrome had been observed in the clinical trials for both FDA-approved RSV prefusion F protein vaccines, but that it remained unclear whether those cases were actually caused by RSV vaccination or just chance occurrences.”
  • and
    • The CDC has issued new guidance —  its first since 1988 — on identifying and responding to clusters of suicide, as tens of thousands of lives are lost to suicide each year in the U.S.
    • Though suicide clusters are rare, they “can have unique characteristics and challenges,” and “are often highly publicized and can have considerable negative effects on the community, including prolonged grief and elevated fear and anxiety about further deaths,” Michael Ballesteros, PhD, of CDC’s National Center for Injury Prevention and Control (NCIPC), and colleagues wrote in Morbidity and Mortality Weekly Report (MMWR).
  • Beckers Hospital Review informs us,
    • “The CDC is anticipating a shortage of Td vaccines — which protect against tetanus and diphtheria — as the maker of one shot has discontinued production. 
    • “As a result, the CDC has updated guidance for providers and is recommending that they switch to administering Tdap vaccines, which protect against pertussis in addition to tetanus and diphtheria, whenever possible.  
    • “MassBiologics discontinued production of its TdVax shot, and while Sanofi also manufactures a Td vaccine and is working to boost supplies, the CDC anticipates the U.S. could see a shortage of the vaccines later this year. 
    • “Because not everyone can receive the Tdap vaccine, “the limited supply of Td vaccine needs to be preserved for those with a contraindication to receiving pertussis-containing vaccines,” the CDC said in its guidance.” 
  • Medscape notes,
    • “Injectable weight loss drugs like Wegovy, Saxenda, and Zepbound have been getting all the glory lately, but they’re not for everyone. If the inconvenience or cost of weight loss drugs isn’t for you, another approach may be boosting your gut microbiome.
    • “So how does one do that, and how does it work?
    • “In theory, all you have to do is boost your gut microbiome.
    • “There are a lot of different factors naturally in weight gain and weight loss, so the gut microbiome is certainly not the only thing,” said Chris Damman, MD, a gastroenterologist at the University of Washington. He studies how food and the microbiome affect your health. “With that caveat, it probably is playing an important role.”
  • STAT News adds,
    • “New obesity drugs like Wegovy and Zepbound are currently taken once a week, indefinitely. But what if they could be taken once a year instead, like a vaccine?
    • “That’s a question that Novo Nordisk, the pharma company behind Wegovy, is exploring as it faces increased competition from other drugmakers aiming to develop similar GLP-1-based treatments for obesity.
    • “We have a very early think tank on: what would it take us, from a technology point of view and from an ecosystem point of view, to make long-lasting GLP-1 molecules?” Marcus Schindler, Novo’s chief scientific officer, said in an interview with STAT Wednesday. “Could we think about vaccine-like properties, where imagine you had, once a year, an injection with an equivalent of a GLP-1 that really helps you to maintain weight loss and have cardiovascular benefits?”

From the U.S. healthcare business and cybersecurity issues front,

  • Beckers Hospital Review informs us,
    • “Optum’s Change Healthcare confirmed Feb. 29 that it was hacked by a ransomware gang after the group claimed to have stolen massive amounts of data.
    • “Change Healthcare can confirm we are experiencing a cybersecurity issue perpetrated by a cybercrime threat actor who has represented itself to us as ALPHV/Blackcat,” an Optum spokesperson emailed Becker’s on Feb. 29. “We are actively working to understand the impact to members, patients and customers.” * * *
    • “ALPHV/Blackcat, aka BlackCat, claimed responsibility for the hack, posting on its dark web leak site that it stole 6 terabytes worth of Change Healthcare data involving “thousands of healthcare providers, insurance providers, pharmacies, etc,” Bleeping Computer reported Feb. 28. The allegedly stolen data includes medical records, patient Social Security numbers, and information on active military personnel (Change serves some military healthcare facilities).
    • “But as Politico noted Feb. 28: “Ransomware groups, which demand extortion payments in exchange for restoring or not publishing stolen data, often exaggerate their exploits as a negotiating tactic.”
    • “ALPHV/Blackcat, which has been linked to Russia, has been targeting the U.S. healthcare industry since December after the FBI disrupted its operations.”
  • STAT News adds,
    • “The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT.
    • “UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline. He said that program will last “for the next couple of weeks as this continues to go on.”
    • “McMahon’s remarks about the loan program highlight the scope of UnitedHealth’s damage control. UnitedHealth maintained it has “not determined the [cyberattack] incident is reasonably likely to materially impact our financial condition or results of operations,” according to its annual report to investors this week. But doctors and pharmacists are scrambling to find ways to get patients what they need, and to get paid. As of 2022, Change facilitated $1.5 trillion in health care transactions.”
  • HR Brew lets us know,
    • “The cost of healthcare went up last year, according to a new report from Marsh McLennan Agency (MMA), a US-based subsidiary of global brokerage Marsh. The amount that employers spent on health benefits per employee grew by 5.2%, while the estimated cost of employer contributions to premiums increased by more than $1,400, to $11,762.
    • “Healthcare inflation can affect employees, as well, the report noted, with 38% of Americans reporting they put off medical treatment in the last year due to cost concerns. MMA noted that “delayed care is associated with worse health outcomes and higher costs for patients and benefit providers.”
    • “Younger workers appear to be feeling the pinch of high health costs the most, with 74% of millennial and 56% of Gen Z patients canceling doctors’ visits because of high costs, compared to 13% of Baby Boomer patients. Putting off behavioral healthcare, in particular, can be costly for younger age groups, said Monte Masten, chief medical officer with MMA. Given these trends, employer investment in incentives may be warranted, he told HR Brew.”
  • Drug Store News alerts us,
    • “Walgreens’ VillageMD is closing six Chicago clinic locations—five standalone and one co-located with a Walgreens store, per a Telehealth & Telecare Aware report.
    • “The closures in Walgreens’ home state are set to take place April 19. These closures follow on the heels of news last week that VillageMD exited the Florida market.” 
  • Per Fierce Healthcare,
    • “Telemedicine clinic Virta Health believes its members can achieve significant and sustained improvement in weight loss, even if a patient has stopped taking a GLP-1 drug, a newly released paper in Diabetes Therapy shows.
    • “According to the company, it is a first-of-its-kind study offering an opposing viewpoint against clinical trials showing GLP-1 deprescription leading to weight regain. The results have potentially major implications for employers and plans looking to help its members improve health outcomes and fight obesity but that are concerned about rising costs amid increasing demand.
    • “This is unheard of,” said Sami Inkinen, Virta Health CEO and co-founder. “To my knowledge, nobody has published or shown this kind of data to date.”
  • Beckers Health Payer Issues points out five health insurers that “are making commitments to advance a White House initiative to end hunger and reduce diet-related disease by 2030.” 
  • Per BioPharma Dive,
    • “Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders.
    • “Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round announced Thursday, alongside Alaska Permanent Fund Corporation and The Column Group. The investment is the first announced by Cure since it debuted last year with a $350 million fund. Euclidean Capital and Saisei Ventures also participated in the round.
    • “Previously known as Ryne Bio, Kenai’s research aim is to create so-called off-the-shelf cell therapies that replace neurons. The company’s most advanced medicine is made from genetically reprogrammed stem cells and designed to treat Parkinson’s disease by restoring dopamine production.
    • “The medicine has “displayed robust survival, innervation, and behavioral rescue in preclinical models of Parkinson’s disease,” according to Kenai, which claims it could work in inherited forms of the disease as well as in cases where the exact cause isn’t understood.
    • “The company said the funding proceeds will be enough to push the medicine, named RNDP-001, into human testing and through early-stage clinical trials, which should start within the year.”

Weekend Update

David Ermer–Congress, Federal employment benefits, Government Contracting, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The House of Representatives and the Senate continue to engage in Committee business and floor voting this week. The Committee for a Responsible Federal Budget reminds us
    • “The [current continuing resolution (CR)] measure extends the “laddered” approach from the previous CR, with the first set of appropriations bills expiring on Friday, March 1: Agriculture, Energy-Water, Military Construction-VA, and Transportation-HUD (these were previously set to expire Jan. 19). The second set of appropriations bills would expire a week later, on Friday, March 8: Commerce-Justice-Science, Defense, Financial Services-General Government, Homeland Security, Interior-Environment, Labor-HHS-Education, Legislative Branch, and State-Foreign Operations bills (these were previously set to expire Feb. 2).”
  • On February 1, The Government Accountability Office
    • “issue[d] a new revision of the Generally Accepted Government Auditing Standards, also known as the “Yellow Book,” which supersedes the 2018 revision of the standards. The Yellow Book is the book of standards and guidance for government auditing—outlining the requirements that make for effective, quality audits when reviewing government programs and spending. It’s used by our federal government auditors here at GAO, as well as federal, state and local auditors; inspectors general; and auditors of entities that receive government awards. 
  • The February 1 WatchBlog post takes a closer look at this important guidance and GAO’s updates.
  • Independent auditors base their audits of experience rated FEHB plans on the Yellow Book and related OPM guidance.
  • Last Tuesday, the Accreditation Association for Ambulatory Healthcare (AAAHC) released its updated FEHB Accreditation Handbook. Employee organization plans in the FEHB Program are accredited by AAAHC.
  • Reg Jones, writing in FedWeek, offers primers on annual leave and sick leave for federal and postal employees.

From the public health front,

  • The Wall Street Journal reports,
    • “Medical centers are starting programs to identify patients’ chances of cognitive decline and recommend ways to delay or prevent it. Most patients are in their 40s to 60s; some clinics take patients as young as 18. Insurance covers some services, otherwise tests and visits can range from hundreds to thousands of dollars.
    • “Doctors in these clinics counsel patients to make personalized lifestyle changes, such as building resistance training into workouts or eating more leafy greens. They also recommend medications to treat conditions linked to Alzheimer’s risk, such as statins for high cholesterol. There’s no guarantee of preventing the disease or other forms of dementia, however, and some doctors are skeptical of these programs. * * *
    • “If every primary-care doctor in every primary-care practice did prevention well, then this program may not need to exist,” says Dr. Zaldy Tan, who heads the new Memory & Healthy Aging Program at Cedars-Sinai. “But we know that that doesn’t happen.” 
  • MedTech Dive tells us,
    • Medical devices patients can use at home, such as infusion pumps and ventilators, are the top health technology hazard of 2024, a nonprofit patient safety organization said Wednesday.
    • ECRI named at-home devices as the top hazard in response to examples of harms such as medication errors with the use of infusion pumps that suggest products “may be too complex for laypeople to use safely and effectively.”
    • The group identified inadequate or onerous device cleaning instructions as the second biggest hazard of the year, reflecting evidence that reprocessing failures can spread infections.

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing.
    • “The fund, which would be Arch’s 13th, is being put together less than two years after the firm closed a similar-sized $3 billion raise that was its largest to date. Plans were outlined in a filing Arch made this week with the Securities and Exchange Commission. The form was signed by Arch managing director and CFO Mark McDonnell.
    • “Arch declined to comment on the filing.”
  • The New York Times reports
    • “A sharp shift in health care [spending?] is taking place as more than one-third of American adults now supplement or substitute mainstream medical care with acupuncture, meditation, yoga and other therapies long considered alternative.
    • “In 2022, 37 percent of adult pain patients used nontraditional medical care, a marked rise from 19 percent in 2002, according to research published this week in JAMA. The change has been propelled by growing insurance reimbursement for clinical alternatives, more scientific evidence of their effectiveness and an increasing acceptance among patients.
    • “It’s become part of the culture of the United States,” said Richard Nahin, the paper’s lead author and an epidemiologist at the National Center of Complementary and Integrative Health, a division of the National Institutes of Health. “We’re talking about the use for general wellness, stress management use, sleep, energy, immune health.”
    • “And for pain management. The use of yoga to manage pain rose to 29 percent in 2022 from 11 percent in 2002, an increase that Dr. Nahin said reflected in part efforts by patients to find alternatives to opiates, and the influence of media and social media.”
  • Fortune Well adds,
    • “According to the Global Wellness Summit’s 2024 trends report from the Global Wellness Institute, which combines research and insights from experts in the field—including scientists, CEOs, and academics—the wellness market is surging. And it’s not expected to slow down anytime soon. 
    • “The U.S. tops the global list of countries for spending on wellness, amassing an annual market of $1.8 trillion, up 14% since 2020. On average, people in the U.S. spend $5,321 per year on wellness, coming in 5th behind the Seychelles, Switzerland, Iceland, and Aruba.”         

Friday Factoids

David Ermer–COVID-19, FDA, Government Contracting, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC,

  • Govexec informs us,
    • “According to the Biden administration’s quarterly update of its progress in fulfilling the President’s Management Agenda, released last month, the White House is keeping pace with its stated goals of strengthening the federal workforce and modernizing customer experience. 
    • “The latest Performance.gov post touts 5,800 new hires targeted for roles created by the Bipartisan Infrastructure Law and promises eight new pooled hiring efforts to support multi-agency hiring in fiscal 2024, amid other milestones situated across multiple strategy goals. 
    • “Likewise, the goal of making it easier for the public to interact with the federal government’s life experience services is progressing with the stand-up of several pilot programs, and its High Impact Service Providers are aligning operations and workforce capacity to eventually begin reporting customer feedback data.” 
  • BioPharma Dive reports,
    • “For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers there.
    • “The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the safety and supply of medicines shipped from abroad. Supporters have argued that importing drugs from Canada, where medicines cost far less than in the U.S., could help rein in pharmaceutical costs. * * *
    • “The pharmaceutical industry, which has vehemently opposed importation plans, may also sue to block Florida’s plan.
    • “We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” a spokesperson for the industry lobby PhRMA said in an email. “PhRMA is considering all options for preventing this policy from harming patients.”
  • Note the FEHBlog is ambivalent about this decision.
  • The Federal Times discusses a contract protest related delay in implementing new TRICARE contracts.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid is surging again, four years after the pandemic began, as a new virus subvariant becomes dominant in the U.S. and as people gather indoors to escape cold weather.
    • “Rising wastewater virus levels and hospitalizations underscore the latest winter Covid surge. One driver is JN.1, the latest offshoot of the virus to take over in the U.S. and an Omicron subvariant. The Centers for Disease Control and Prevention on Friday estimated that JN.1 represents roughly 62% of cases nationwide.
    • “The good news is measures of severe illness—hospitalizations and deaths—remain below last winter’s highs and far lower than the pandemic’s peaks. But the virus remains dangerous for some and a major nuisance for many as people return to work and school after holiday breaks.
    • “The world has seen a steady cycle of new Omicron subvariants ever since that offshoot rapidly took over more than two years ago. When new versions become dominant, it indicates that they have some advantage, whether through their ability to evade immune defenses or easily spread from person to person.”
  • The FEHBlog credits Omicron for being an upper respiratory infection, which is much less dangerous than the initial waves of Alpha and Delta Covid, which were lower respiratory infections.
  • The CDC’s FluView notes,
    • “Seasonal influenza activity is elevated and continues to increase in most parts of the country.
    • “Outpatient respiratory illness has been above baseline1 nationally since November and is above baseline in all 10 HHS Regions.
    • “The number of weekly flu hospital admissions continues to increase.
    • “During Week 52, of the 651 viruses reported by public health laboratories, 581 (89.2%) were influenza A and 70 (10.8%) were influenza B. Of the 342 influenza A viruses subtyped during Week 52, 300 (87.7%) were influenza A(H1N1) and 42 (12.3%) were A(H3N2).”
  • Behavioral Health Business discusses
    • “How Fentanyl has changed Opioid Use Disorder Treatment,”
  • and
    • “Top behavioral health trends for 2024.”
  • The American Medical Association offers top health tips obesity medicine physicians want you to know.
  • The National Institutes of Health Director announced in her blog,
    • “Nearly 35 million people in communities across the U.S. have type 2 diabetes (T2D), putting them at increased risk for a wide range of serious health complications, including vision loss, kidney failure, heart disease, stroke, and premature death.1 While we know a lot about the lifestyle and genetic factors that influence diabetes risk and steps that can help prevent or control it, there’s still a lot to learn about the precise early events in the body that drive this disease.
    • “When you have T2D, the insulin-producing beta cells in your pancreas don’t release insulin in the way that they should. As a result, blood sugar doesn’t enter your cells, and its levels in the bloodstream go up. What’s less clear is exactly what happens to cause beta cells and the cell clusters where they’re found (called islets) to malfunction in the first place. However, I’m encouraged by some new NIH-supported research in Nature that used various large datasets to identify key signatures of islet dysfunction in people with T2D.”
  • The NIH further announced,
    • “Semaglutide, a highly popular medication approved by the U.S. Food and Drug Administration to treat obesity and manage type 2 diabetes, was associated with a 49% to 73% lower risk of first-time or recurring suicidal ideations compared to other medications for controlling obesity and type 2 diabetes that work via different mechanisms. These findings provide evidence that semaglutide – which helps regulate appetite and insulin levels by targeting glucagon-like peptide 1 receptors (GLP1R) in the body – does not appear to increase the risk of suicidal ideation, contrary to the claims of some anecdotal reports. Published today in Nature Medicine and paired with a related Research Briefing(link is external), the study was co-led by scientists at Case Western Reserve University and the National Institute on Drug Abuse (NIDA), National Institutes of Health.”
  • Per the American Medical Association,
    • “The AP (1/4, Neergaard) reports, “Seizures during sleep are a potential cause of at least some cases of sudden unexplained death in childhood, or SUDC, researchers at NYU Langone Health reported Thursday after analyzing home monitoring video that captured the deaths of seven sleeping toddlers.” The study “offers the first direct evidence of a seizure link,” although “scientists also have found that a history of fever-related seizures was about 10 times more likely among the children who died suddenly than among youngsters the same age.” The findings were published in the journal Neurology.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “The cost of treating a COVID-19 hospital patient in the hospital rose by 26% over the first two years of the pandemic, more than five times the rate of medical inflation during that time, according to a newly published analysis of 1.3 million admissions.
    • “On average and after adjustments, direct treatment costs for a COVID-19 hospital admission rose from $10,394 in March 2020 to $13,072 in March 2022, a gain that researchers said landed alongside increased use of breathing assistance machines.
    • “Such technologies proved to be costly; stays in which a COVID-19 patient required extracorporeal membrane oxygenation (ECMO), for instance, averaged $36,484 and increased by 35% over the course of the study period, they wrote in JAMA Network Open.
  • Forbes reports,
    • “Health insurance giant Elevance Health said it has agreed to acquire Paragon Healthcare, Inc., a provider of infusion services to patients.
    • “Elevance said Paragon provides infusion services to patients through its “omnichannel model of ambulatory infusion centers, home infusion pharmacies, and other specialty pharmacy services.” Financial terms of the deal for privately held Plano, Texas-based Paragon were not disclosed.
    • “It’s the latest effort by Elevance Health to bolster its specialty pharmacy business and pursue its strategy to treat the whole health of the person. Last year, Elevance Health, which operates Blue Cross and Blue Shield health plans in 14 states, closed on its acquisition of BioPlus, a specialty pharmacy.”
  • Healthcare Dive reports,
    • “Tom Cowhey, a financial executive at CVS who stepped into the interim CFO role late last year, has been permanently named to the post, the company announced on Friday.
    • “In October, Cowhey replaced Shawn Guertin, who served as CFO and president of health services. Guertin, who has been on a leave of absence due to family health reasons, will now officially leave CVS later this year, the company said. 
    • “Cowhey joined CVS in early 2022 after previously serving as CFO of Surgery Partners. Before that, he worked at Aetna in strategy and finance positions, before the health insurer was acquired by CVS.”
  • The American Medical Association lets us know,
    • “Significant changes in the Current Procedural Terminology (CPT®) code set for immunizations reflect the changing nature of how COVID-19 is being addressed as actions transition from a public health emergency response to combatting emerging variants much like the flu.
    • “One significant change involves the consolidation of more than 50 previous codes to streamline reporting of immunizations for COVID-19. A new vaccine-administration code, 90480, was approved for reporting the administration of any COVID-19 vaccine for any patient. This replaces all previously approved, product-specific vaccine-administration codes. * * *
    • “Additionally, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an advisory group of the FDA, recommended that the COVID-19 vaccine for the 2023–2024 vaccination season be a monovalent vaccine that contains the XBB.1.5 strain, and noted that a number of COVID-19 vaccine products will no longer be recommended for use. The streamlined structure brings greater alignment between CPT and the current COVID-19 vaccine reporting environment.
    • “The new coding system will allow for new vaccines for new variants whenever they come up without having to do a new code,” said Samuel “Le” Church, MD, MPH, a member of the CPT Editorial Panel and vice-chair of its Immunization Coding Caucus.”
  • Mercer Consulting offers seven breakthrough benefit strategies to explore this year.

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Government Contracting, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network offers its periodic update on the bills pending before Congress of interest to federal employees.
  • American Hospital Association News tells us that today
    • “The Department of Health and Human Services’ Office for Civil Rights released a proposed rule intended to update and clarify requirements under Section 504 of the Rehabilitation Act that prohibit discrimination on the basis of disability in programs receiving financial assistance from the department, including health care. According to HHS, the proposed rule would ensure that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities; prohibit the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when used to limit access or to deny aids, benefits and services; establish enforceable standards for accessible medical diagnostic equipment; and clarify obligations for accessible web and mobile applications and obligations to provide services in the most integrated setting appropriate to an individual’s needs. The rule will be published in the Sept. 14 Federal Register, with comments accepted for 60 days.”
  • The Federal Times points out
    • “The Office of Personnel Management received a small surge of retirement claims in July and August after applications had been falling steadily for months since January.
    • “The time it took the government to process retirements increased sharply in July to 85 days before falling back down to 74 days in August, according to data kept by OPM.
    • “Overall, the agency is sitting on an inventory of nearly 18,000 cases after it reduced its working caseload to new lows this year. About this time last year, there were 29,000 pending cases.
    • “Still, despite efforts to dispatch focus teams to address backlogs, the agency is failing to hit its target time or inventory goals, leaving retirees to wonder whether their case will be one that ends up sitting in limbo for longer. Ideally, retirement applications are processed in 60 days or fewer.”
  • CMS released its 2022 report on covered entity compliance with the HIPAA electronic transactions.
    • The transaction types experiencing the most violations during the 2020 and 2021 compliance reviews were specific to 835 [the claim transaction], 271 [Health Care Eligibility Response], and 277 [Claim Status Response] transactions. This changed slightly in 2022 as the most common transaction types experiencing violations are now 835, 271, and 834 [EOB] transactions.
    • CMS is sharing updated 2022 violation findings insights to inform and educate the industry, encourage widespread compliance, and assist covered entities with preparing for compliance reviews.
  • The Society for Human Resource Management relates,
    • The U.S. Equal Employment Opportunity Commission (EEOC) has released an updated deadline for employers to submit their demographic data. The EEO-1 Component 1 data collection for 2022 will start on Oct. 31, and the deadline for employers to file their EEO-1 reports is Dec. 5.
    • All private employers that have at least 100 employees are required to file the EEO-1 form annually, detailing the racial, ethnic and gender composition of their workforce by specific job categories.
    • Likewise, federal government contractors and first-tier subcontractors with 50 or more employees and at least $50,000 in contracts must file EEO-1 reports. State and local governments and public school systems are exempt.
  • KFF reports
    • “Over the past two years, the federal government has provided about $1 billion from the American Rescue Plan and Bipartisan Safer Communities Acts to launch the number, designed as an alternative to 911 for those experiencing a mental health crisis. After that infusion runs out, it’s up to states to foot the bill for their call centers.
    • “We don’t know what Congress will allocate in the future,” said Danielle Bennett, a spokesperson for the federal Substance Abuse and Mental Health Services Administration, which oversees 988. “But the hope is that there will be continued strong bipartisan support for funding 988 at the level it needs to be funded at and that states will also create funding mechanisms that make sense for their states.”
    • “Only eight states have enacted legislation to sustain 988 through phone fees, according to the National Alliance on Mental Illness, which is tracking state funding for the system. Others have budgeted short-term funding. But many predominantly rural states, where mental health services are in short supply and suicide rates are often higher than in more urban states, have not made long-term plans to provide support.”
  • MedPage reports,
    • When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, it left oral phenylephrine (with brands including Sudafed PE and Suphedrine PE) as the only nasal decongestant available without pharmacy assistance. But there’s one big problem: phenylephrine doesn’t work, the FDA has finally determined.
    • FDA reviewers released the results of their long-running review of the evidence this week as background for a meeting of the Nonprescription Drugs Advisory Committee to be held on September 11 and 12.
    • The article explains the conundrum this finding creates for the FDA.

From the public health front,

  • MedPage reports that “the global incidence of early-onset cancer has increased by 79% over the past three decades, researchers reported.
    • “In a comment posted on Science Media Centre, Dorothy C. Bennett, MA, PhD, of St. George’s, University of London, cautioned that the increase in new cases of early-onset cancer is based on absolute numbers, rather than age-standardized rates.
    • “The world human population increased by 46% between 1990 and 2019, which explains part of the increase in total case numbers,” she said, adding that the increase in numbers of cancer deaths in this age group (28%) was notably lower than the number of new diagnoses, “which is below the increases in total population and case numbers, indicating a fall in the average cancer death rate in this group.”
  • Per the American Heart Association,
    • Obesity-related cardiovascular disease deaths tripled between 1999 and 2020 in the U.S.
    • Such deaths were higher among Black individuals (highest among Black women) compared with any other racial group, followed by American Indian/Alaska Native people.
    • Black adults who lived in urban communities experienced more obesity-related cardiovascular disease deaths than those living in rural areas, whereas the reverse was true for all other racial groups.
  • McKinsey Health offers a podcast about getting to the bottom of the teen health crisis.

From the U.S. healthcare business front,

  • Fierce Healthcare notes, “Employers’ health benefits costs are set to rise 5.4% next year, but this spike isn’t as high as may have been feared given inflationary pressures in the broader economy, according to a new analysis from Mercer.”
  • STAT News interviews “Amazon’s chief medical officers on where the company’s health care bets are headed next.”
  • Healthcare Dive informs us,
    • “Telehealth sessions comprised 5.4% of claim lines in June, the same amount as the prior month, according to Fair Health’s Monthly Telehealth Regional Tracker.
    • “Mental health conditions continued to top the list of Fair Health’s five most common telehealth diagnoses for June. The median allowed amount billed for a one-hour psychotherapy visit was $103.
    • “But Fair Health’s tracker showed regional variations. Although telehealth use decreased overall by 2.4% in the Midwest, asynchronous telehealth claim lines for mental health conditions more than doubled in the region from 15.9% in May to 36% in June. In asynchronous telehealth, providers collect data or medical images for review, instead of meeting with a patient in real time.” 
  • Per Health Affairs,
    • “Intensive care units (ICUs) are increasingly used for hospital care, yet out-of-pocket spending for ICU hospitalizations remains poorly understood, particularly among the nearly half of the US population with commercial health insurance. Using 2008–19 MarketScan data, we compared 1,441,810 hospitalizations involving ICU services with 13,011,208 hospitalizations that did not involve ICU services.
    • “Average cost sharing, adjusted for patient and admission factors, increased from $1,137 per hospitalization in 2008 to $1,539 in 2019, or a 34 percent increase. This was driven by increasing deductibles, which rose by 163 percent.
    • “Across twenty clinical conditions whose hospitalizations commonly occurred in both ICU and non-ICU settings, ICU admission was associated with $155 higher cost-sharing (13.0 percent higher) relative to cost sharing in non-ICU hospitalizations.
    • “Patients with high-deductible plans faced the highest cost-sharing relative to those with other plan types.
    • “Patients who received out-of-network hospital care encountered higher cost-sharing relative to those admitted to in-network hospitals with in-network clinicians.”

Midweek Update

David Ermer–Congress, COVID-19, Government Contracting, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington DC,

  • Govexec informs us,
    • “The House and Senate appeared headed for a short-term spending deal when lawmakers return to Washington following the August recess, with leaders from both chambers suggesting they are pursuing that path to avoid a shutdown in October. 
    • “The continuing resolution would keep agencies funded at their current levels through early December, House Speaker Kevin McCarthy, R-Calif., told his caucus this week. Senate Majority Leader Chuck Schumer, D-N.Y., said on Wednesday he met with McCarthy a few weeks ago, and the two leaders agreed to pass a stopgap that would last “a few months.” 
    • “I thought that was a good sign,” Schumer told MSNBC. 
    • “Separately on Tuesday, Schumer said the short-term measure would allow lawmakers to come together on full-year appropriations.”
  • Federal News Network says,
    • For the second year in a row, the General Services Administration announced an increase to per diem lodging rates for federal employees.
    • Starting Oct. 1, base daily traveling allowances for feds will increase to $166 from $157 last year. That increase is thanks to an uptick in the standard per diem lodging rate for the Continental United States (CONUS), which will increase from $98 to $107. GSA did not make any changes to the per diem tiers for meals and incidental expenses. Those will remain in the range of $59 to $79, with the standard rate remaining at $59. * * *
    • GSA also offers a calculator tool to let feds search by city, state, zip code or map to figure out the exact amount of their per diem.
  • The Federal Acquisition Regulation cost principles apply these per diems to official travel by FEHB experience-rated carriers.

From the public health front,

  • The Washington Post reports,
    • Most cancers in the United States are found in people age 65 and older, but a new study shows a concerning trend: Cancer among younger Americans, particularly women, is on the rise, with gastrointestinal, endocrine and breast cancers climbing at the fastest rates.
    • A study published Wednesday in JAMA Network Open showed that while cancers among older adults have declined, cancers among people younger than 50 have increased slightly overall, with the largest increases among those aged 30 to 39.
    • “This is a population that has had less focus in cancer research, and their numbers are getting bigger, so it’s important to do more research to understand why this is happening,” said Paul Oberstein, director of the Gastrointestinal Medical Oncology Program at NYU Langone’s Perlmutter Cancer Center, who was not involved in the study.
  • STAT News points out
    • “Cancer patients, doctors, and patient advocates alike are struggling with the wide-ranging effects of the ongoing chemotherapy drug shortages. The platinum-based drugs carboplatin and cisplatin have been hard to keep in stock for months now, affecting most U.S. cancer centers: 93% have reported carboplatin shortages, and 70% have reported shortages of cisplatin.
    • “While patients with various types of cancer have been impacted by the shortages, those with ovarian cancer are among the groups most affected — both because the disease is relatively common, with women having a 1 in 78 chance of getting it in their lifetime, and because the drugs that are most effective in treating it are the ones now in short supply.
    • “While there are alternatives to the use of platinum drugs to treat ovarian cancer, none of them work quite as well. Carboplatin, in particular — in combination with the chemotherapy drug paclitaxel — has remained unchallenged as the go-to for ovarian cancer, in particular when the treatment could be curative rather than palliative.
  • Forbes relates
    • “New Covid omicron subvariant EG.5, or “Eris,” is now the dominant strain in the U.S., surpassing XBB.1.16 (or “Arcturus”), according to new data from the Centers for Disease Control and Prevention.
    • “EG.5 made up 17.3% of all cases in the two-week period from July 23 to August 5, a large jump from the 0.4% of cases it made up between April 30 and May 13.
    • “The World Health Organization classified EG.5 as a “variant of interest” Wednesday, which is a step below a variant of concern—WHO previously labeled it a “variant under monitoring” on July 19.
    • “While EG.5 may cause an increase in cases, WHO said it poses a low risk to public health in comparison to other omicron offspring because there’s no evidence it causes more severe cases.
    • “It is a recombinant strain—the result of two Covid variants combining during the replication process, which can occur if a person is infected with two variants at the same time—of the omicron family and a descendant of another strain labeled XBB.1.9.2.
    • “EG.5 has an extra mutation on its spike called mutation 465, which is present in about 35% of coronavirus sequences worldwide—a lot of the XBB variants have mutation 465, though experts don’t know what comes with the mutation.”

From the judicial front,

  • The Wall Street Journal reports,
    • “A federal appeals panel ruled that the Food and Drug Administration improperly expanded access to the widely used abortion pill mifepristone over the last seven years but left in place the drug’s original approval, teeing up the issue for review by the Supreme Court. 
    • “The ruling by a three-judge panel of the New Orleans-based Fifth U.S. Circuit Court of Appeals is the latest twist in a case that has at times threatened to pull the pill from the market nationwide.
    • “The appeals panel said pill opponents who sued the FDA had likely waited too long to challenge the drug’s original approval in 2000, and it also left in place the agency’s 2019 approval of the generic version of the pill. But the court said the FDA failed to properly scrutinize changes that eased access to mifepristone in recent years, such as allowing the drug to be administered without an in-person visit with a medical provider. * * *
    • “The appeals court decision doesn’t have immediate practical consequences because the Supreme Court in April issued an order allowing current broad levels of access to mifepristone while litigation proceeds. That is likely to ensure availability for months.”

From the U.S. healthcare business front,

  • Per Forbes
    • “Demand for nurse practitioners and primary care physicians is escalating along with their compensation as retailers from Amazon and CVS Health to Walmart and Walgreens build primary care clinics across the country.
    • “A new report from AMN Healthcare shows nurse practitioners—not doctors—topped the staffing company’s list of “most requested search engagements for the third consecutive year,” according to an annual report released Monday from AMN Healthcare’s Physician Solutions division, formerly known as Merritt Hawkins.
    • “Demand for NPs is being driven by a growing number of ‘convenient care’ providers, including retail clinics, urgent care centers and telemedicine platforms, which employ large numbers of NPs,” the report said.”
  • Beckers Hospital Review notes,
    • “Ozempic might find itself in CMS’ hands soon.
    • “Sales of the Type 2 diabetes drug in the U.S. have reached more than $3 billion so far in 2023, according to an Aug. 10 quarterly report from the drug’s maker, Novo Nordisk. CMS might try to influence the company to lower the medication’s cost, which sits at about $1,000 per month.
    • “In August 2022, President Joe Biden signed the Inflation Reduction Act, which gave Medicare Parts B and D negotiation powers for costly drugs with no generic or biosimilar competition. CMS said it will reveal by Sept. 1 which are the first 10 drugs that will see price negotiations, which are effective in 2026. This allowance will add more drugs each year. 
    • “Researchers from the Washington, D.C.-based West Health Policy Center and the University of California San Diego predicted Ozempic would be chosen for these negotiations in 2027 — when it passes 10 years on the market, one of the rules of the Inflation Reduction Act provision — according to a study published in March.”
  • Business Insurance adds,
    • “The U.S. Department of Justice has contested the Chamber of Commerce’s move to block the Medicare drug price negotiation program, stating the Chamber lacks the standing for the lawsuit and that halting the program would be detrimental to the public, The Hill reports. The Chamber had previously filed for an injunction against the program, citing potential harm to businesses and patients.”
  • Fierce Healthcare identifies “22 health systems that are charging for certain patient-provider electronic messages as of Aug. 16.” These systems are trying to squeeze the last golden egg out of the goose, in the FEHBlog’s opinion.

 

Monday Roundup

David Ermer–Congress, Government Contracting, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Politico points out that

The Senate Finance Committee will hold a hearing Thursday on the impact PBMs — the pharmaceutical middlemen that negotiate drug discounts with drugmakers and design prescription drug benefits for health plans — have on the health system.

The House Energy and Commerce Health Subcommittee is also expected to look into how much value PBMs add as part of a broader discussion about fairness in the healthcare market, according to a memo shared with [Politico].

In related news, CMS “released several Prescription Drug Data Collection (RxDC) resources on the Registration for Technical Assistance Portal (REGTAP). To view the documents, click on the link next to each document title. You may already have the links in your bookmarks.”

This guidance applies to the 2022 RxDC report that health plans must submit by June 1, 2022. Health plans submitted the first RxDc report for the 2021 reporting year last January. The No Surprises Act calls for a standard June 1 submission date for the RxDC report for the previous reporting year.

CMS also announced that the public has sixty days (to May 26) to comment on the revised Reporting Instructions.

The FEHBlog recently discovered this CMS REGTAP portal. As you can see, this portal is not just for Medicare and Medicaid. The portal includes a link to get an email announcement when REGTAP changes. REGTAPs emails are handy and not overwhelming.

From the Rx coverage front —

STAT News adds an interesting perspective on last week’s Senate hearing on Moderna Covid vaccine pricing

What, [Chairman Bernie] Sanders asked [Moderna CEO Stephane Bancel], if instead of purchasing medicines after they had been developed at high prices, the government instead paid for companies’ research, enough to ensure they make a reasonable profit? Then, Sanders said, the medicines could be made available inexpensively to anyone who needed them.

Bancel, clearly baffled by what sounded a lot like the government seizing the means of pharmaceutical production, simply said it was impossible to evaluate such a plan without details.

As much as the plan sounds like socialism, in a world where substantial quantities of new medicines are purchased by government programs, Sanders’ idea is pretty close to the way defense companies work: The government pays them substantial amounts of money to develop jet fighters, satellites, and aircraft carriers. This system is certainly not cheap, but it represents an alternative to the way medicines are developed. * * *

Whether this is a good idea or not, it probably won’t happen. Because not only is Congress unlikely to fund a $200 billion-a-year effort to replace industry research on new medicines, it won’t fund a $20 billion effort to get the government in the game, either.

Beckers Hospital Review informs us

Walgreens and Village Medical have launched a new pilot program that helps patients manage new medications prescribed during their hospital stay. 

The program, launched as a pilot in Florida and Texas, helps Walgreens and Village Medical patients manage their new prescriptions and existing ones after they are discharged from a hospital, according to a March 23 release from Walgreens. 

The aim of the program is to improve patient outcomes and decrease costs associated with hospital readmissions.

From the substance use disorder front, STAT News reports

Public health workers will soon have a new tool at their disposal to thwart a spreading danger to users of illicit drugs: xylazine test strips.

The new testing kits will allow health departments, grassroots harm-reduction groups, and individual drug users to test substances for the presence of xylazine, a sedative often referred to as “tranq.”

The toxin is increasingly common in the U.S. illicit-drug supply — especially in the Philadelphia area, but increasingly in other cities, too. Xylazine, which is typically used as a sedative in veterinary settings, can cause people to stop breathing, and also often causes severe skin wounds when injected.

While helpful for public health workers, will drug users take the time to do both tests when the two potentially fatal drugs usually are combined? FEHBlog expects that a fentanyl and xylazine test strip will be on the market soon.

From the U.S. healthcare business front —

  • Hospitals strongly oppose MEDPAC’s recommendation that Medicare Part A make a low reimbursement increase for the new federal government fiscal year, while some healthcare economists support MEDPAC’s proposal.
  • Healthcare Dive tells us
    • “CVS plans to close its acquisition of home healthcare provider Signify Health on or around Wednesday, subject to certain conditions, the company announced Monday.
    • “CVS agreed to acquire Signify for $30.50 a share in cash in September in a transaction worth roughly $8 billion.
    • “That deal will close this week as long as CVS and Signify can meet or waive the remaining conditions in their merger agreement, according to CVS. A CVS spokesperson declined to share details on the remaining conditions.
  • Beckers Hospital Review notes that another well know CEO has ripped a page out of the Mark Cuban playbook.
    • “Love.Life, a health and wellness company co-founded and run by former Whole Foods CEO John Mackey, acquired Plant Based TeleHealth, a telehealth service focusing on the prevention and reversal of chronic conditions.
    • “The company will rebrand as Love.Life Telehealth. The company offers virtual visits to patients with chronic conditions and promotes healthy behaviors, according to a March 21 Love.Life news release.
    • “Patients can sign up for half-hour appointments for $175 or hourlong appointments for $350.”
    • “Love.Life is about making lasting health and vitality achievable, and acquiring Plant Based TeleHealth accelerates our ability to help more people without geographic limitations,” Mr. Mackey said. “Appointments are available now, and we’re excited to offer telehealth services as part of the comprehensive medical offering available in our physical locations, which will begin opening in 2024.”

Thursday Miscellany

David Ermer–COVID-19, Government Contracting, Medicare, Mental health care, NIH–
Photo by Josh Mills on Unsplash

From the public health front, the Wall Street Journal reports

The cancer mortality rate in the U.S. has dropped by a third in the past three decades, a report showed, but an increase in advanced prostate cancer diagnoses threatens to reverse some hard-won gains.  

The American Cancer Society said Thursday that changes in preventive measures and screening in the past decade drove important trends in U.S. cancer incidence and outcomes. Cervical cancer rates dropped 65% from 2012 to 2019 among women in their early 20s after a generation of young women were vaccinated against human papillomavirus, or HPV, for the first time.

But a decline in the use of a controversial test for prostate cancer likely led to more men getting diagnosed at later stages, the report found, with the highest incidence and mortality among Black men. The ACS said it would invest in research on prostate cancer and programs to boost access to quality screening and treatment. 

“There’s a significant call to arms,” said Karen Knudsen, ACS’s chief executive officer. “We are not catching these cancers early when we have an opportunity to cure men of prostate cancer.” 

The report was published in the journal CA: A Cancer Journal for Clinicians. The authors at ACS analyzed federal and state cancer registries for data on cancer rates through 2019 and federal mortality data through 2020, the report said.

From the Omicron and siblings front, Bloomberg Prognosis tells us

The effects of long Covid tend to resolve within a year of mild infection, with vaccinated people at lower risk of breathing difficulties compared with unvaccinated people, according to a study.

Researchers examined the health records of almost 2 million people in Israel who tested for Covid-19 over a 19-month period. Over 70 long Covid conditions were analyzed within a group of infected and matched uninfected members. They also compared conditions in vaccinated versus unvaccinated people.

Their study published in the BMJ medical journal found most symptoms that developed after a mild infection lingered for several months, but returned to normal within a year.

“The long Covid phenomenon has been feared and discussed since the beginning of the pandemic,” the researchers wrote. “This nationwide dataset of patients with mild Covid-19 suggests that mild disease does not lead to serious or chronic long term morbidity.” 

Previous studies have indicated that vaccination tends to lead to milder cases of Covid infection and long Covid

From the Rx coverage front, STAT News informs us

Medicare officials have taken a step toward making a cutting-edge cancer treatment called CAR-T cell therapy available in doctor offices, in anticipation of the procedure being used for increasingly common cancer types.

CAR-T is a relatively new medical procedure that uses a person’s own cells to fight their cancer, and it offers hope of a cure for those who have run out of options. It’s a complex procedure with a lot of serious side effects that must be closely monitored, so it’s typically provided at hospitals in the inpatient setting, sometimes outpatient, and almost never in doctor offices.

There are multiple barriers to offering CAR-T cell therapies in doctor offices, according to James Essell, medical director of the Blood Cancer Center at OHC and chair of cellular therapy for the US Oncology Network, a large network of independent doctors that includes OHC. Insurers restrict coverage to facilities that specialize in the procedure, and it’s financially risky for practices. Treating a few patients would require a practice to shell out well more than $1 million for the drugs alone, and the process of getting paid is arduous and not guaranteed, Essell said. * * *

Since the first CAR-T drug, Novartis’ Kymriah, was approved in 2017, the procedure has primarily been available at major academic hospitals. That puts the treatments out of reach for patients who don’t live near those facilities. Essell said less than 20% of patients who are eligible for the treatments are able to get them. Physician practices could help make the treatment available to the other 80%.

“You really need to get this out of the university centers to allow more patients to receive this care,” he said.

Mercer Consulting discusses strategies for providing access to and managing the cost of highly expensive gene therapies.

The second half of 2022 was marked by significant activity in the gene therapy market, with several landmark FDA approvals, including Hemgenix, a $3.5M gene therapy indicated for treatment of Hemophilia B. With this hefty price tag, Hemgenix wins the title of most expensive drug in the world, knocking down the previous title holder, the $2.1M gene therapy called Zolgensma, indicated for spinal muscular atrophy. * * *

As Hemgenix and other high-cost gene therapies enter the market, employers should create a long-term comprehensive approach to managing these therapies from a clinical and cost perspective by exploring a broad spectrum of strategies. A key first step in tailoring strategies specific to your plan involves assessing the likelihood of these claims occurring in your plan’s population; ideally, such assessments should be conducted on a regular basis as the member population changes. Once you get a better understanding of your unique population and the potential risk for these claims, inventory and evaluate available vendor strategies for gaps and opportunities. This step may include reviewing your medical carrier’s utilization management programs, network strategy, and care management programs, checking for availability of outcomes-based reimbursement and other payment models, and exploring alternative approaches to funding these claims. Lastly, as the market continues to evolve, regularly engage with your medical and pharmacy vendor on availability of new strategies.

The American Hospital Association adds

The Centers for Medicare & Medicaid Services yesterday released a memo and timeline outlining how it will approach implementing the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, which will negotiate prices with drug makers for certain high-cost, sole-source drugs and apply them beginning in 2026. According to the memo, CMS plans to actively engage hospitals and other stakeholders in the policymaking process.

From the medical research front, the National Institutes of Health discusses an ongoing study on the use of deep brain stimulation to treat severe opioid addiction.

From the litigation front, a divided panel of the U.S. Court of Appeals for the Sixth Circuit today upheld a lower court’s preliminary injunction of the federal government’s government contractor mandate but similar to the approach taken by the 5th Circuit limited the scope of the protection of the injunction to the plaintiffs, here the States of Kentucky, Ohio, and Tennessee. For more information, here’s the Volokh Conspiracy article on the decision. The 5th, 6th, and 11th Circuits have all ruled against the government contractor mandate, which the Safer Federal Workforce Task Force has put on ice.

Midweek update

David Ermer–COVID-19, Federal employment benefits, Government Contracting, OPM, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the federal employment front —

  • Govexec explains how federal employees can calculate their 2023 pay raises.
  • The Federal Times discusses how the Secure 2.0 Act, part of the Consolidated Appropriations Act 2023, affects federal employee retirement programs.

Healthcare Dive identifies key trends for payers and providers in 2023.

This year’s outlook for a large chunk of the healthcare sector remains negative as inflation and pricier labor create difficult operating conditions for nonprofit providers, Moody’s Investor Service said. 

As a result, health systems and hospitals are likely to clash with insurers over desired rate increases to offset higher expenses and providers will look to increase their revenue as much as possible by bargaining for higher rates.

Becker’s Hospital CFO Report fills us in on the highlights of a Fitch Ratings webinar on healthcare

Five things to know:

  1. There will continue to be “extremely contentious” negotiations between healthcare providers and payers, Mr. Holloran said. An “above average” exiting of contracts and networks is expected.
  2. There will be far more labor strikes in 2023 with “very contentious” labor negotiations, Mr. Holloran said. Unions will be quick to move as healthcare systems seek to recruit and retain “on steroids.”
  3. Regional differences will continue to emerge. The fast-growing Southern states of Florida, Texas and Georgia will see significant capital expenditure, for example, while regions with declining populations and others will seek to tighten such expenses.
  4. There will be increased merger and acquisition activity even as the Biden administration takes a harder look at potential anti-competitive behavior. “We know everyone is talking to everyone else” about ways in which they can partner, Mr. Pascaris said. “It’s a very interesting time for M&A as increased levels of stress will likely include greater levels of M&A.”
  5. Healthcare systems cannot spend their way out of financial difficulties because the cost of labor will remain very high. The 75/75 conundrum where most systems’ revenues are fixed at 75 percent and most have a similar 75 percent fixed expense in terms of salaries and supplies is an “unstainable” model, Mr. Holloran said.

From the public health front,

  • The Secretary of Health and Human Services extended the Omicron public health emergency for another 90 days today.
  • STAT News explores “What’s standing in the way of wastewater data becoming a more mainstream public health tool.”

Moderate-to-severe hearing loss was linked with a higher prevalence of dementia, a cross-sectional study of Medicare beneficiaries showed.

Among 2,413 older adults in the National Health and Aging Trends Study (NHATS), dementia prevalence among people with moderate-to-severe hearing loss was higher than it was among people with normal hearing (prevalence ratio 1.61, 95% CI 1.09-2.38), reported Nicholas Reed, AuD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues.

But among people with moderate-to-severe hearing loss in the study, hearing aid use was associated with a lower prevalence of dementia compared with no hearing aid use (prevalence ratio 0.68, 95% CI 0.47-1.00), they wrote in a JAMA research letter.

The findings support a recent systematic review and meta-analysis that showed treating hearing loss led to cognitive benefits. They also support the availability of over-the-counter hearing aid, which people with mild-to-moderate hearing loss now can purchase directly due to new regulations.

Given the FEHB’s demographics, FEHB plans should take a look at improving health aid coverage for 2024.

From the U.S. healthcare business front

  • Fierce Healthcare reports on today’s events at the J.P. Morgan Healthcare conference.
  • The following Fierce Healthcare report from the conference caught the FEHBlog’s eye today

Fertility benefits are becoming a major lever in the ongoing talent wars, and that’s good news for Progyny.

The eight-year-old company, which provides family building and fertility benefits for employees at large firms, launched with five clients and 110,000 covered lives. Today, Progyny has more than 370 clients with 5.4 million covered lives.

“In the past year given the current macroeconomic environment, inflationary economy an a potential looming recession, despite all that, for Progyny and its members, it’s proven to be a resilient space. People aren’t foregoing and or deferring family building, in light of all those things, and companies aren’t deferring their decisions,” Pete Anevski, Progyny’s CEO, told Fierce Healthcare on the conference sidelines.

From the telehealth front, McKinsey and Company explain how healthcare organizations can tackle the following problem:

Using national claims data,3 we estimate that more than 50 million in-person visits per year could be converted to virtual or telemedicine visits if adoption were extended equally across patient segments. In general, patient segments with limited access to in-person care (for example, those in rural counties and those with lower incomes) have relatively fewer virtual visits. While many believe virtual care can improve access for the underserved, the current imbalance in usage suggests that US healthcare stakeholders could consider designing virtual-care models that address structural barriers so that virtual care is more widely accessible.

Check it out.

Federal procurement contracts, including FEHB contracts, include a clause requiring contractors to support government efforts to combat human trafficking. During the human trafficking awareness month, the Government Accountability Office reports

Tens of millions of people are victims of human trafficking each year, according to one international organization’s estimate. Human trafficking victims are often held in slave-like conditions and forced to work in the commercial sex trade or other types of servitude. The U.S. government has also found forced labor overseas in various industries producing goods imported into the U.S., such as agricultural and seafood industries.

Several U.S. government entities work with international entities to combat human trafficking. Today, for National Human Trafficking Awareness Day (January 11), our blog post looks at our work reviewing these efforts and our snapshot highlighting areas where continued attention is needed.