Midweek Update

FDA

Midweek Update

David Ermer–Congress, FDA, Medical / Rx research, Medicare, NIH, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Washington Post reports,
    • “The White House on Wednesday backed proposals to permanently stiffen penalties on synthetic-drug traffickers, monitor machines used to make fentanyl pills and close a loophole that allows criminal groups to easily ship drugs in packages.
    • “President Biden announced the initiatives as state and federal officials from both political parties grapple with how to curb a drug epidemic that has killed more than 300,000 people during his administration.
    • “The crisis is fueled by fentanyl, the potent synthetic opioid manufactured by Mexican criminal groups and smuggled into the United States. Border security has proved to be a political flash point, with Republicans hammering the White House about the failure to stop fentanyl from entering the country.”
  • American Hospital News informs us,
    • “At a Capitol Hill briefing July 31, hospital and health care leaders shared strategies and stories highlighting the importance of passing the Safety from Violence for Healthcare Employees Act (H.R. 2584/S. 2768), bipartisan legislation that would provide federal protections against violence to hospital workers.  
    • “The panel featured: Mark Boucot, president and CEO of Potomac Valley Hospital in Keyser, W.Va., and Garrett Regional Medical Center in Oakland, Md.; Rachel Culpepper, DNP, RN, general medicine service line director at Indiana University Health West Hospital in Avon, Ind.; and James Phillips, M.D., an emergency room physician in Washington, D.C. and chair of disaster medicine at the American College of Emergency Physicians. Sen. Joe Manchin, I-W.Va., author of the Senate bill, also delivered remarks.  
  • and
    • “The Centers for Medicare & Medicaid Services July 31 issued a final rule for fiscal year 2025 for the skilled nursing facility prospective payment system, which will increase aggregate Medicare spending by 4.2% or $1.4 billion compared to FY 2024. This reflects a 3% market basket update, a 1.7 percentage-point increase to counter the agency’s market basket error in FY 2023, and a 0.5 percentage point cut for productivity. CMS also revised its regulations regarding its nursing home enforcement authority to allow the agency to impose additional financial penalties on facilities where health and safety deficiencies are identified.”
  • and
    • The Centers for Medicare & Medicaid Services July 31 released the fiscal year 2025 final rule for inpatient rehabilitation facilities, which will update IRF payments by an estimated 3% overall (or $300 million) in FY 2025. This includes a 3.5% market basket update, which is reduced by a 0.5 percentage point cut for productivity. However, IRF payments will be further decreased by an estimated 0.2% ($20 million) due to the updated outlier threshold. 
  • and
    • “The Centers for Medicare & Medicaid Services July 31 issued the final rule for the inpatient psychiatric facility prospective payment system for fiscal year 2025. CMS will increase IPF payments by a net 2.5%, equivalent to $65 million, in FY 2025. This increase includes a market-basket update of 3.3% minus a productivity adjustment of 0.50 percentage points; it also accounts for an update to the outlier threshold so that estimated outlier payments will remain at 2.0% of total payments, resulting in a 0.3% decrease to aggregate payments.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced more than $68 million in Ryan White HIV/AIDS Program funding to provide family-centered medical care and essential support services for women with low incomes, infants, children, and youth with HIV. This announcement supports and advances the Biden-Harris Administration’s National HIV/AIDs Strategy.” * * *
    • “HRSA’s Ryan White HIV/AIDS Program provides a comprehensive system of HIV primary medical care, medication, and needed support services to more than 560,000 people with HIV who have low incomes. The program focuses on tailoring approaches to best meet people with HIV and their communities where they are and addressing factors, like access to food, childcare, housing, and transportation that directly affect the ability of patients to enter and stay in care.”  
  • Govexec informs us,
    • “The Senate Homeland Security and Governmental Affairs Committee on Wednesday unanimously advanced legislation codifying recent changes to the federal hiring process stressing applicants’ skills and experience over educational attainment.” * * *
    • “By a 10-1 vote, the panel [also] moved legislation expanding the list of federal positions in which employees are “further restricted” from partisan political activity under the Hatch Act. Sen. Rand Paul, R-Ky., was the lone dissenter.
    • “The bill (S. 4656), introduced by Sen. Chuck Grassley, R-Iowa, and Committee Chairman Gary Peters, D-Mich., would add employees of agency offices of inspectors general to the Hatch Act’s list of employees with additional guard rails on political activity, alongside other oversight agencies like the Office of Special Counsel and Merit Systems Protection Board and national security organizations like the National Security Agency and FBI.”

From the public health and medical research front,

  • STAT News lets us know,
    • “Patients with early Alzheimer’s disease treated with a medication developed by Eisai and Biogen for up to three years experienced less cognitive decline than what’s expected of untreated patients based on historical data, according to new study results reported Tuesday. The manufacturers said the data support long-term, continuous use of the drug.
    • “The three-year benefit seen in patients provided Leqembi remains modest — a 31% slowing of cognitive decline, slightly more than a 27% slowing previously seen in an 18-month placebo-controlled trial. It’s still unclear if the new data will convince doctors to use Leqembi continuously, or if the treatment’s benefit is clinically meaningful for patients, experts told STAT. * * *
    • “Eisai’s argument for continuing Leqembi treatment contrasts with Lilly’s approach to its [similar FDA approved] drug Kisunla. Lilly argues that once amyloid is cleared in treated patients, they can stop the therapy, making Kisunla a more convenient option, and potentially less expensive compared to continuous dosing.”
  • MPR points out,
    • “The Food and Drug Administration (FDA) has approved Zunveyl (benzgalantamine) for the treatment of mild to moderate dementia of the Alzheimer type in adults.” * * *
    • “The approval of Zunveyl is a pivotal moment in the fight against Alzheimer disease as it is only the second oral AD treatment to be approved in more than a decade,” said Michael McFadden, CEO of Alpha Cognition. “Zunveyl was designed to address a critical need for a tolerable and effective treatment that can potentially enhance patients’ daily lives with improved long-term outcomes.”
    • Zunveyl is supplied as 5mg, 10mg, and 15mg delayed-release tablets. The product is expected to be available in the first quarter of 2025. 
  • The National Cancer Institute posted its latest Cancer Information Highlights.
  • At this link, Beckers Hospital Reviews points out “eight new shortages to know about, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists”

From the U.S. healthcare business front,

  • Per Beckers Payer Issues,
    • “Humana reported $679 million in net income in the second quarter of 2024. 
    • “The company published its second quarter earnings report July 31. In Q2 2023, Humana posted $959 million in net income.
    • “Total revenue in the second quarter was $29.5 billion, up 10.4% year over year. 
    • “Humana’s medical loss ratio was 89% in the second quarter.”
  • Modern Healthcare notes,
    • “An unexpected spike in inpatient utilization during the latter half of the quarter, which continued into July, dinged Humana’s finances. Executives cited the effects of the two-midnight rule, which requires insurers to cover inpatient stays when providers expect patients to remain in the hospital for at least two midnights. The company expects this trend to persist through 2024.”
  • Healthcare Dive adds,
    • “Medicare Advantage giant Humana expects to lose a “few hundred thousand” members in its marquee business next year, after seriously shrinking its benefits and exiting markets for 2025 in a bid to boost profits, the insurer disclosed Wednesday.
    • “It’s the first time Humana has estimated membership losses from culling its plans, and squares with past guesses from market watchers. MA margins should improve as a result, setting Humana on the path to a long-term target of at least 3%, management told investors on a call. Currently, analysts peg Humana’s MA margin as basically flat, as the Kentucky-based payer has been rocked by rising medical costs among seniors in the privately run Medicare plans.
    • “However, Humana also expects to emerge from 2024 stronger from a membership perspective than it previously thought. The insurer now expects to add 225,000 MA members this year, up from its previous forecast of 150,000 new lives.”
  • Per Fierce Healthcare,
    • “In its first quarter with new CEO Chuck Divita, national telehealth provider Teladoc Health posted a net loss of $838 million in Q2 that included a nearly $800 million impairment charge attributed to falling expectations for its virtual mental health solution, BetterHelp.
    • “Teladoc is withdrawing its 2024 outlook, and its three-year business outlook based on its Q2 losses. It now expects low single-digit year-over-year revenue growth for 2024. BetterHelp’s revenue in Q2 decreased 9% from Q2 2023, to $265 million.
    • “Amid slowing growth in recent quarters with a saturated telehealth market and the abrupt departure of longtime CEO Jason Gorevic in April, the company’s net loss skyrocketed in Q2 2024 to $837.7 million, or $4.92 per share, compared to a loss of $65 million, or $0.40 per share, during the same quarter a year ago.” * * *
    • “Divita said transitioning BetterHelp to accept insurance is the next logical step for the company. Customers that leave the platform cite high out-of-pocket costs and lack of insurance coverage, he noted.
    • “BetterHelp expects to have the technical capabilities for insurance coverage by year-end and expects insurance contracting to roll out over the course of 2025.”
  • Per BioPharma Dive,
    • “GSK on Wednesday lowered its forecast for vaccine sales this year, citing inventory changes and shifting retail prioritization in the U.S. for its shingles shot Shingrix.
    • “The British pharmaceutical company now expect sales from its vaccines division to increase by low to mid-single digit percentages, down from the high single digit to low double-digit growth it predicted in May.
    • “Shingrix, now one of GSK’s top products, earned 832 million pounds, or about $1.1 billion, in the second quarter, down from the first three months of the year but up year to date. Sales of Arexvy, the company’s new vaccine for respiratory syncytial virus, totaled 62 million pounds as demand eased along expected seasonal patterns.”
  • Per MedTech Dive,
    • “Stryker set another record in the second quarter for installations of its Mako orthopedic robot, ahead of two planned launches of spine and shoulder features later this year.  
    • “As you’ve seen, quarter after quarter, our Mako installations are very high. That leads to future strong demand for hips and knees,” Stryker CEO Kevin Lobo told investors on Tuesday. 
    • “This is the third quarter in a row where management has noted record installations, BTIG analyst Ryan Zimmerman said in a research note. 
    • “The results drove more than 14% sales growth in Stryker’s “other orthopedics” segment to $136 million.”
  • This link provides an explanation of how the Mayo Clinic uses the Mako orthopedic robot in hip and knee replacement surgeries.
  • Per MedPage Today,
    • “Trust in physicians and hospitals decreased sharply during the COVID-19 pandemic, and higher levels of trust were tied to greater odds of getting vaccinated for COVID-19 or influenza, according to a survey study of U.S. adults.
    • “Among over 400,000 unique respondents, the proportion of adults who agreed they had “a lot of trust” in physicians and hospitals declined from 71.5% in April 2020 to 40.1% in January 2024, reported Roy Perlis, MD, MSc, of Massachusetts General Hospital in Boston, and colleagues in JAMA Network Open. * * *
    • In regression models, factors associated with lower trust as of the spring and summer of 2023 included being 25 to 64 years of age, female gender, lower educational level, lower income, Black race, and living in a rural setting. Even when the researchers controlled for partisanship, these associations persisted. * * *
    • “We as physicians and public health officials can talk until we’re blue in the face about things like vaccination and other public health behaviors,” Perlis commented. “But if people don’t trust us, it doesn’t matter — we’re talking to ourselves.” * * *
    • “Perlis and his team also gathered information about why respondents had low levels of trust. Participants with the two lowest levels of trust identified the following reasons: financial motives over patient care (35%), poor quality of care and negligence (27.5%), influence of external entities and agendas (13.5%), and discrimination and bias (4.5%).”
  • FEHBlog observation: Wow.
  • The Society for Human Resource Management tells us,
    • “After an unexpected surge in pay and benefits in the first quarter, labor costs have slowed down in the second quarter but still remains robust.
    • “The Employment Cost Index (ECI) increased 0.9% in the second quarter of the year, new data finds, after rising 1.2% last quarter, according to Bureau of Labor Statistics data released July 31. Wages and salaries increased 0.9% and benefit costs increased 1% from March 2024. Many economists forecasted that the ECI would rise 1%.
    • “Year over year, compensation costs in the U.S. for civilian workers—including pay and benefits—rose 4.1%, down slightly from the 4.2% year-over-year rise in the first quarter of 2024. Meanwhile, compensation for state and local government workers is up 4.9%.
    • “Wages and salaries grew 4.2% for the 12-month period ending in June 2024 and rose 4.6% for the 12-month period ending in June 2023, according to the BLS. Benefit costs grew 3.8% over the year and rose 4.2% for the 12-month period ending in June 2023.” * * *
    • “Although wage growth appears to be slowing, it’s still robust, said Sydney Ross, junior economic researcher at SHRM.
    • “As shown in the recent JOLTS report, employers are still dealing with a tight labor market and persistent talent shortages across key industries,” she said. “This means there will be more competition between employers for skilled talent, especially for those in specialized industries.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Medical Economics alerts us,
    • “The hot seat in Washington, D.C., could get hotter for pharmacy benefit managers (PBMs) when the Federal Trade Commission (FTC) meets next week to discuss its recent report on the drug price middlemen.
    • “Meanwhile, a consortium of pharmacy groups is demanding federal lawmakers pass reforms they say are needed to regain control of the pharmaceutical market. A PBM trade group countered that legislators need a balanced and accurate discussion, not just repetition of claims of Big Pharma, which stands to benefit if PBMs lose their price bargaining power.
    • “As public discourse about PBMs at times rises to a clamor, the FTC announced its Aug. 1 open meeting will include a presentation on the Commission’s Interim Report on Pharmacy Benefit Managers (PBMs).”
  • FEHBlog note — PBMs do a more than negotiate prices with drug manufacturers and wholesalers. For example, PBMs also seamlessly process drug claims for consumers.  
  • Beckers Hospital CFO Report tells us,
    • “The U.S. economy saw a 2.8% increase in gross domestic product in the second quarter of 2024, reflecting a spike in consumer spending, nonresidential fixed investment and private inventory investment. 
    • “The first quarter saw GDP grow only 1.4%, according to the Bureau of Economic Analysis.
    • “Consumer spending also increased in goods and services. Healthcare, utilities, recreation services, and housing led service contributors. Motor vehicles and parts, furnishing and durable household equipment, gasoline and recreational goods led goods contributors.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention (“CDC”) announced today,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity has increased in most areas.
    • “COVID-19
      • “Most areas of the country are experiencing consistent increases in COVID-19 activity. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are increasing, particularly among adults 65+. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • The University of Minnesota CIDRAP adds,
    • “Nationally, wastewater detections of SARS-CoV-2 have been at the high level over the past few weeks, with the highest levels in Western states over the summer months. However, the CDC’s latest data show though detections in the West are still the highest in the nation, the level declined in the most recent reporting week.
    • “Wastewater detections are still rising steadily in the South. In the Midwest and Northeast, detections are still increasing, but at a slower pace.”
  • STAT News points out,
    • “The number of confirmed human infections with the bird flu virus associated with the ongoing outbreak in dairy cattle has risen to 13, the Centers for Disease Control and Prevention announced Thursday, as it confirmed three additional cases in Colorado. They are currently designated simply as H5 and not H5N1 because CDC labs are still working on typing the neuraminidase, the N number in the virus’ name, STAT’s Helen Branswell reports.
    • “The cases — one of which Colorado had previously announced as a “presumptive positive” — are in people who were culling infected poultry on a farm in the state. Genetic analysis of the virus in that poultry outbreak shows that it is similar to the virus circulating in cows; it’s believed this is one of several instances where H5N1 in cow herds has spilled over into nearby poultry operations. Of the 13 human cases, 10 have been detected in Colorado, which also has the highest number of reported infected dairy herds — 51, according to the state’s Department of Agriculture. Michigan and Texas have reported two and one human case, respectively.”
  • The Detroit Free Press reports,
    • “Liverwurst and several other deli meat products produced by Boar’s Head Provisions Co., Inc., based in Jarratt, Virginia, are being recalled because they may be contaminated with the Listeria monocytogenes bacteria, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) on Friday announced.
    • “Additional deli meat products produced on the same line and same day as the liverwurst are also being recalled because of potential listeria contamination.
    • “In total, more than 207,000 pounds of products are being recalled.
    • “The FSIS is concerned because some products may be in consumers’ refrigerators and in retail deli cases.”
  • MedPage Today discusses issues with the CDC’s bird flu virus vaccine.
  • Mercer Consulting explains why GLP-1 drug dislocation calls for a holistic approach to weight-loss.
  • U.S. News and World Report informs us,
    • “Cancer growth can be fueled by flecks of ancient viral DNA lodged into the genetics of modern humans, a new study says.
    • “Overall, about 8% of the human genome is made of bits of DNA left behind by viruses that infected our primate ancestors, researchers say.
    • “Called “endogenous retroviruses,” these DNA fragments have long been considered harmless junk littering the modern human genetic profile, researchers said.
    • “But new research shows that when reawakened, these ancient viral strands can help cancer survive and thrive, researchers reported July 17 in the journal Science Advances.
    • “What’s more, shutting up these viral voices from the past can make cancer treatments more effective, researchers found.
    • “Our study shows that diseases today can be significantly influenced by these ancient viral infections that until recently very few researchers were paying attention to,” said senior researcher Edward Chuong. He’s an assistant professor of molecular, cellular and developmental biology at the University of Colorado, Boulder’s BioFrontiers Institute.”

From the U.S. healthcare business front,

  • The Wall Street Journal looks at the drug shortage problem from the perspective of a courageous American who invested in a failing Amoxicillin plant located in Bristol, TN.
    • “A cavernous factory in northeastern Tennessee, by the Virginia border, is one of the last in the country that makes a vitally important medicine.
    • “Each day the USAntibiotics plant churns out a million doses of the crucial antibiotic amoxicillin that promise to cure Americans of everything from earaches to pneumonia—and ease a pressing shortage for children.
    • “But the plant’s prospects are dim. It can’t charge enough to cover overhead, because competitors sell their wares at bargain prices. USAntibiotics isn’t close to breaking even.
    • “It’s not for lack of trying,” said Rick Jackson, a health-staffing businessman who rescued the factory from near bankruptcy two years ago and has poured more than $38 million into purchasing and refurbishing it.
    • “The generic drug business has become a hostile environment for American companies. Prices for the often-critical medicines have dropped so low that it has become difficult for U.S. manufacturers to compete with companies overseas.”  * * *
    • “Jackson is holding out hope the federal government will help the plant. But if it doesn’t in the next year and a half, he said would shut the factory down.
    • “It’s not a failure yet,” Jackson said. “If there is a way to do it, we’ll figure it out.”
    • FEHBlog note – Hopefully the front-page WSJ article will help generate outside investment.
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Friday raised its forecast for revenue and profit per share this year after a second quarter in which sales of its older products and new drugs surpassed analyst expectations.
    • “The “beat and raise” followed similarly strong earnings reports this week from AstraZeneca, Roche, Sanofi and AbbVie, all of which upped either their revenue or profit estimates for 2024. Shares in Bristol Myers rose by nearly 9% in Friday morning trading on the news.
    • “Between April and June, Bristol Myers reported earning $12.2 billion in sales, 6% higher than Wall Street consensus forecasts. Second quarter earnings per share were $2.07 on an adjusted basis, 27% higher than estimated, according to Leerink Partners analysts.”Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies.[1] The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.
  • Cardiovascular Business reports,
    • “Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies. The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • “A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • “If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.”
    • FEHBlog note: Bravo.

Midweek Update

David Ermer–AHRQ, CDC, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal adds,
    • “A summer Covid wave is hitting the country, but there’s one consolation: Your chances of developing long Covid have fallen since the start of the pandemic. 
    • “That’s the finding from a new study in the New England Journal of Medicine. It concluded that about 10% of people infected with the virus’s original strain developed long Covid. By contrast, the risk of developing long Covid dropped to 3.5% with the virus’s Omicron variant among vaccinated people. For the unvaccinated, the risk was 7.7.%.
    • “Researchers defined long Covid as people who experienced persistent and debilitating symptoms such as a racing heartbeat or brain fog, or other new health problems linked to the initial illness, a month or more after their infection.
    • “About 70% of the drop in long Covid cases was due to vaccination and 30% because of changes in the virus itself, the study determined. 
    • “Four years since the start of the pandemic, we’re getting used to periodic waves of Covid cases, including the uptick we’re seeing now, driven by Omicron subvariants. The threats of severe illness and lingering health problems have significantly subsided, though they haven’t disappeared.”
  • Beckers Hospital Review reports,
    • “As the House Committee on Oversight and Accountability investigates pharmacy benefit managers regarding alleged anticompetitive practices, the committee scheduled a hearing with leaders of the top three PBMs. 
    • “On July 23, [at 10 am ET], members of the House Committee on Oversight and Accountability plan to ask executives at Express Scripts/Evernorth, CVS Caremark and OptumRx about the alleged anticompetitive policies, which committee members say raise prescription drug costs, harm independent pharmacies and obstruct patient care. 
    • “The three PBMs account for about 80% of the market share. 
    • “The called witnesses are Adam Kautzner, PharmD, president of Evernorth Care Management and Express Scripts; David Joyner, executive vice president of CVS Health and president of CVS Caremark; and Patrick Conway, MD, CEO of OptumRx.”
  • The FEHBlog discovered today that on July 11, 2024, Rep. Gary Palmer (R Ala.) introduced House Jt. Resolution 187 which reads,
    • “Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That Congress disapproves the rule submitted by the Office of Personnel Management relating to Postal Service Reform Act; Establishment of the Postal Service Health Benefits Program (89 Fed. Reg. 37061), and such rule shall have no force or effect.”
  • The cited rule is the OPM’s May 2024 supplemental rule implementing the PSHBP. In the FEHBlog’s opinion, the provision of the rule which offends Rep. Palmer (and the FEHBlog) for that matter is found in an OPM FAQ:
    • “While the proposed rule reflects that Medicare Part D-eligible annuitants and their Part D-eligible family members would be automatically group enrolled into the Part D EGWP, it reflects that they may choose to opt out of receiving prescription drug coverage through the PSHB Part D EGWP. This proposed rule provides, consistent with the statute, that the Part D EGWP offered by their PSHB plan is the only PSHB prescription drug benefit available for Part D-eligible PSHB annuitants and their Part D-eligible covered family members. As proposed, Medicare Part D-eligible annuitants and their family members who choose to opt out of or disenroll from the PSHB plan’s Part D EGWP would not have access to prescription drug benefits through their PSHB plan and would not pay a lower premium than those enrolled in the Part D EGWP.“
  • Nothing in the Postal Service Reform Act suggests that Congress intended to impose such a penalty. It’s a penalty because OPM does not reduce the premium for members who are deprived of their plan’s prescription drug benefits. Furthermore, when Congress included a mandate for PSHBP annuitants to enroll in Part B, it also provided grandfathering protections and exemptions. The Part D penalty applies across the board.
  • In any case, because Part D benefits will feature improvements such as a $2,000 out of pocket cost maximum for 2025, the carrot approach to incenting Part D EGWP enrollment should be tried first.
  • The American Hospital Association News lets us know,
    • “The Administration for Strategic Preparedness and Response July 16 announced it will work with the Department of Commerce on an assessment of the active pharmaceutical industrial base to better understand the pharmaceutical supply chain and how it has changed since the COVID-19 pandemic. The assessment is based on a survey conducted last winter. The study will inform federal strategies and funding decisions related to the API supply chain and raise awareness of potential supply chain issues, such as the current limited domestic manufacturing capabilities and other potential issues. The study will survey more than 200 companies, including manufacturers, distributors, suppliers and customers. A Bureau of Industry and Security webpage answers FAQs about the project.”

From the public health and medical research front,

  • STAT News tells us,
    • “The Centers for Disease Control and Prevention just released a trove of data on Americans with disabilities that found that more than a quarter of U.S. adults have a disability — over 70 million people, a bump from prior years. This slice of the population was also much more likely to report long Covid symptoms such as chronic fatigue and brain fog. This comorbidity looms large for many disabled communities as another surge in Covid cases sweeps the country.
    • “The data, gathered in 2022, is part of the agency’s Disability and Health Data System, which has annual state and national-level data stretching back to 2016. This is the first year that the agency has released long Covid data, finding that 11% of people with disabilities had long Covid symptoms while only 7% of people without disabilities reported symptoms.
    • “For many disabilities, the highest populations exist in a swath that extends from the Deep South and Louisiana up to Appalachian communities in West Virginia and Ohio. Disability benefits claims are typically highest in these areas, but for long Covid, the geography shifted west. Idaho and other states along the Continental Divide saw much higher rates of symptoms, with Montana recording the highest prevalence at 18%.”
  • The New York Times adds,
    • “A large new study provides some of the strongest evidence yet that vaccines reduce the risk of developing long Covid.
    • “Scientists looked at people in the United States infected during the first two years of the pandemic and found that the percentage of vaccinated people who developed long Covid was much lower than the percentage of unvaccinated people who did. 
    • “Medical experts have previously said that vaccines can lower the risk of long Covid, largely because they help prevent severe illness during the infection period and people with severe infections are more likely to have long-term symptoms.
    • “But many individuals with mild infections also develop long Covid, and the study, published Wednesday in The New England Journal of Medicine, found that vaccination did not eliminate all risk of developing the condition, which continues to affect millions in the United States.”
  • STAT News also informs us,
    • “A study published Wednesday in the Journal of Clinical Oncology found that certain unmatched donors, or people whose bone marrow does not as closely resemble that of the patient’s, provided similar outcomes to matched donors so long as patients receive a key drug called cyclophosphamide to prevent dangerous complications. That suggests that patients who need a transplant might be able to safely consider both matched and some unmatched donors, vastly expanding the pool of potential acceptable donors for all patients, though particularly those of African, Latino, or Asian ancestry.
    • “It’s much harder to find a match for most of my patients. Looking to people who are donor unrelated and aren’t a perfect match for my patients has become the norm,” said Sekeres, who is the chief of hematology at Sylvester Cancer Center at the University of Miami and did not work on the study. “That’s why this study really resonated with me. The classic teaching is you want a perfect match as opposed to less than perfect. What this study suggests is, if you use the right drugs after transplant, it may not be as big of a deal.”
    • “If so, up to roughly 84% of African American patients might have a potential donor in the national registry. Currently, less than 30% of African American patients have a potential match in the NMDP registry, previously called the National Marrow Donor Program.”
  • Per BioPharma Dive,
    • “A closely watched obesity pill being developed by Roche helped people in a small Phase 1 trial lose 7.3% of their body weight over four weeks when taken once daily — 6.1 percentage points more than those given a placebo, the company said Wednesday.
    • “The data comes two months after the Swiss drugmaker disclosed trial results from another obesity drug in its pipeline, which showed the once-weekly injection helped reduce body weight by 19% over six months. Roche disclosed more detailed data for that drug, indicating none of the trial participants stopped taking it due to side effects — a reason users might quit taking Wegovy or Zepbound.
    • “The two drugs came from Roche’s $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to enter a market estimated to be worth more than $100 billion annually by early next decade.”
  • Beckers Hospital Review interviews NYU Langone’s bariatric surgery chief about the first GLP-1 generic and other GLP-1 issues.
  • Per a National Institutes of Health press release,
    • “A neuroimaging study of young people who exhibit a persistent pattern of disruptive, aggressive, and antisocial behavior, known as conduct disorder, has revealed extensive changes in brain structure. The most pronounced difference was a smaller area of the brain’s outer layer, known as the cerebral cortex, which is critical for many aspects of behavior, cognition and emotion. The study, co-authored by researchers at the National Institutes of Health (NIH), is published in The Lancet Psychiatry.
    • “Conduct disorder has among the highest burden of any mental disorder in youth. However, it remains understudied and undertreated. Understanding brain differences associated with the disorder takes us one step closer to developing more effective approaches to diagnosis and treatment, with the ultimate aim of improving long-term outcomes for children and their families,” said co-author Daniel Pine, M.D., chief of the Section on Development and Affective Neuroscience in NIH’s National Institute of Mental Health. “Critical next steps are to follow children over time to determine if differences in brain structure seen in this study are a cause of conduct disorder or a long-term consequence of living with the disorder.”
  • The National Cancer Institute posted its latest cancer information highlights.
  • The Institute of Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of acoramidis (BridgeBio Pharma, Inc.), tafamidis (Vyndamax®/Vyndaqel®, Pfizer Inc.), and vutrisiran (Amvuttra®, Alnylam Pharmaceuticals, Inc.) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).”
  • AHRQ’s Patient Safety Network informs us,
    • “Patients presenting to the emergency department (ED) are triaged to prioritize care based on level of illness. In this study, 2,543 patients presenting to an ED in Switzerland were asked to self-triage using an electronic symptom-checker. (Patients were triaged and treated based on standard-of-care nurse triage.) Recommendations were given regarding time to treat (e.g., emergency) and point-of-care (e.g., self-care) and subsequently evaluated by three panels of experts. Fifty of the 2,543 patients were judged as undertriaged, but none were judged as potentially hazardous.”

From the U.S. healthcare front,

  • Healthcare Dive points out,
    • “Elevance reported solid second-quarter results on Wednesday — including $2.3 billion in profit — but the company still lowered long-term revenue growth guidance for its health insurance business. That disconnect raised red flags for analysts.”
    • “Changing revenue growth forecasts for health benefits in the middle of the year “is unusual,” commented Jefferies analyst David Windley in a Wednesday note. “We can’t identify a single, large item that would compel [the reduction] off-cycle.”
    • “During a call with investors Wednesday, Elevance management cited several factors for dropping the guidance, including significant member losses from Medicaid redeterminations and Medicare Advantage bids for 2025 that could slow growth.”
  • Fierce Pharma reports,
    • “As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations.”
    • “While J&J is “not in alignment” with IRA or its price setting process, the company has accepted the reality of the situation and baked assumptions about the future costs of its drugs into its growth projections through the end of the decade, Jennifer Taubert, EVP, worldwide chairman, innovative medicine at J&J, said on an analyst call Wednesday.
    • “As it stands, J&J currently expects to grow its business by 3% next year and then 5% to 7% out through 2030, Taubert said.”
  • Per Fierce Healthcare,
    • “Electronic health record messages to patients drafted by generative AI were of similar quality and accuracy to those written by healthcare professionals, according to a newly published study conducted using queries from NYU Langone Health patients.”
    • “The analysis, headed by researchers at the system’s affiliate NYU Grossman School of Medicine, had 16 primary care physicians rate AI and human drafts without knowing how each was written.
    • “Among a sample of 334 AI-drafted messages and 169 from professionals (both physicians and non-physicians), the raters found both sets to be on par regarding informational content, completeness and whether the grader would use the draft or start again from scratch.”
    • “The findings “suggest chatbots could reduce the workload of care providers by enabling efficient and empathetic responses to patients’ concerns,” study lead William Small, M.D., of the medical school, said in a release.”

Friday Factoids

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • Per a Congressional press release,
    • “U.S. Sen. Chuck Grassley (R-Iowa) today applauded the enactment of the bipartisan Maternal and Child Health Stillbirth Prevention Act, a bill [(H.R. 4581)] he championed alongside U.S. Rep. Ashley Hinson (R-Iowa) and U.S. Sens. Bill Cassidy (R-La.) and Jeff Merkley (D-Ore.). The law will help curb infant mortality by enabling evidence-based stillbirth efforts to qualify for federal funding.
    • “Stillbirth prevention researchers and advocates will now have more resources to advance their work. Especially given modern medical and technological capabilities, no family should have to endure the heartbreak of a stillbirth. Many thanks to everyone – Iowa organizations in particular – who’s had a hand in advancing our commonsense bill into law. Today’s win will have a domino effect for expectant families nationwide, for years to come,” Grassley said.  
    • “Today is a huge milestone in our fight to end stillbirth, the unexpected loss of a baby after more than 20 weeks of pregnancy. I am proud to have worked with so many incredible advocates, many of whom have endured the heartbreak of stillbirth, to bring this vital legislation across the finish line and expand federal resources for stillbirth prevention. I thank President Biden for signing this bipartisan legislation into law, and I will continue my work to improve maternal health care access for more healthy moms and healthy babies,” Hinson said. “
  • Fierce Pharma lets us know,
    • “Thursday, the Senate unanimously the bipartisan Affordable Prescriptions for Patients Act [(S. 150)], which looks to limit the number of patents drugmakers can assert in litigation on individual biological products. The bill aims to fight “patent thicketing,” a tactic the branded drug industry uses to delay or thwart competition.
    • “Patent thicketing occurs when drug companies stack secondary drug patents to create a complex web of intellectual property that’s hard for generic or biosimilars developers to navigate. AbbVie, for example, was able to keep its top-selling immunology drug Humira from U.S. competition for two decades by leveraging a web of 250 patents, patient access group Patients for Affordable Drugs Now (P4ADNow) said in a press release.
    • “This long-overdue legislation would promote competition and lower prices for patients without standing in the way of innovation, and I urge my colleagues in the House to pass it as soon as possible,” bill sponsor Sen. John Cornyn, R-Texas, said in a statement. 
    • “Reining in patent thickets would create $1.8 billion in taxpayer savings over the span of a decade, the Congressional Budget Office has forecast.”
  • AXIOS reports
    • “The Biden administration on Wednesday rolled out its latest election-year initiative on women’s health, proposing standards that would require the hospital industry to invest billions in maternity care improvements to remain in Medicare. * * *
    • “Hospitals would have to keep basic resuscitation equipment available in labor and delivery rooms, document maternal health training for staff and have written policies for transferring patients to other hospitals.
    • “All hospitals offering emergency services — even if they lack an obstetrics unit — would be required to have proper protocols and supplies for emergency deliveries and other needs.
    • “Hospitals not following these standards could eventually be booted from the Medicare and Medicaid programs.”
  • The American Hospital Association News adds,
    • “An infographic released by the University of Minnesota Rural Health Research Center highlights the decline of maternity care access in rural counties across the U.S. from 2010-2022, finding that nearly 59% of rural counties did not have any hospital-based obstetric services as of 2022.
    • “Researchers categorized rural counties based on population as micropolitan (having a town of 10,000-50,000 residents) and non-core (without a town of at least 10,000 residents). They found that micropolitan counties with hospital-based obstetric care declined from about 81% in 2010 to nearly 74% in 2022. Noncore counties declined from 34% in 2010 to nearly 26% in 2022.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP tells us,
    • “Respiratory illness viruses as a whole remain at low levels, but many parts of the countries are experiencing consistent increases in COVID-19 activity, which has been trending upward from very low levels, the US Centers for Disease Control and Prevention (CDC) said today in its latest updates.
    • “Test positivity, emergency department (ED) visits, and hospitalizations—the main markers the CDC uses to gauge virus activity—are all rising, especially in both seniors and the western states. * * *
    • “The percentage of ED visits for COVID, considered an early indicator, rose 23.5% last week compared to the week before. Levels were higher in the West and the South than in the rest of the country.” * * *
    • “The dashboard at WastewaterSCAN a national wastewater monitoring system based at Stanford University in partnership with Emory University, shows SARS-CoV-2 detections at the high level, especially in the West, South, and East, with an upward trend over the past 21 days.
    • “In its latest variant update, posted on July 6, the CDC said the proportion of KP.3 detections continues to rise, up from 31.3% to 36.9% over the 2-week monitoring period. KP.3 is one of the JN.1 offshoots with mutations that allow it to better evade immunity from earlier infection or vaccination.” 
  • Per Fierce Pharma,
    • “Trials have already shown that Novo Nordisk’s semaglutide can cut the risk of cardiovascular events and kidney disease. Now a study from the University of Oxford indicates that the company’s semaglutide type 2 diabetes drug Ozempic can reduce the risk of dementia compared with another popular diabetes medicine.
    • “The research—which was designed to demonstrate if Ozempic could cause neurologic problems—showed instead that it produced a 48% decline in dementia when compared to Merck’s type 2 diabetes drug Januvia (sitagliptin).” * * *
    • “Prior studies have determined that diabetics have a greater risk of developing dementia. Those with type 2 diabetes are at an elevated risk for Alzheimer’s, according (PDF) to studies cited by the Alzheimer’s Association.” * * *
    • “Elsewhere, Lilly’s GLP-1/GIP therapy tirzepatide—which is the compound used to manufacture its type 2 diabetes drug Mounjaro and obesity treatment Zepbound—was recently shown to lower blood pressure. Researchers are still studying whether many of these benefits accrue from the treatment or from the weight loss they provide.”
  • The National Institutes of Health announced,
    • Using health data from almost 213,000 Americans who experienced reinfections, researchers have found that severe infections from the virus that causes COVID-19 tend to foreshadow similar severity of infection the next time a person contracts the disease. Additionally, scientists discovered that long COVID was more likely to occur after a first infection compared to a reinfection. The study, funded by the National Institutes of Health’s (NIH) Researching COVID to Enhance Recovery (RECOVER) Initiative, is published in Communications Medicine.
    • “About 27% of those with severe cases, defined as receiving hospital care for a coronavirus infection, also received hospital care for a reinfection. Adults with severe cases were more likely to have underlying health conditions and be ages 60 or older. In contrast, about 87% of those who had mild COVID cases that did not require hospital care the first time also had mild cases of reinfections.
    • “Reinfections were defined as having occurred at least two months after a first infection. They were found to occur most frequently when omicron variants were circulating in late 2021 and early 2022. Waning immunity and increased exposure to the coronavirus, including the highly-infectious variants, likely accounted for the uptick.
    • “Scientists also discovered that regardless of the variant, long COVID cases were more likely to occur after a first infection compared to a reinfection.”
  • The Wall Street Journal reports,
    • “Human lifespan has a limit and we might have reached it.
    • “S. Jay Olshansky, who studies the upper bounds of human longevity at the University of Illinois Chicago, believes people shouldn’t expect to live to 100. Most, he contends, will reach between 65-90.
    • “Biology is holding us back, Olshansky said. Human evolution favors growth and reproduction, not living to excessive ages. As people grow older, their cells and tissues accumulate damage. Breakdowns of one kind or another happen more frequently and get increasingly difficult to repair. Scientists believe there are likely many genes that affect lifespan. Aging is a complex process that isn’t well-understood.
    • “Olshansky knows his viewpoint isn’t popular. 
    • “The longevity business is booming. People are flocking to longevity meetings and taking compounds they hope will extend their lives. Investors are backing scientists researching techniques to reprogram cells to a younger state with the goal of restoring functions that diminish with age. Longevity influencers argue that if they can live long enough, scientific breakthroughs will keep them going indefinitely.” * * *
    • “Jan Vijg, chair of genetics at Albert Einstein College of Medicine in the Bronx, reached a similar conclusion from a different angle. He has studied the maximum verified age the oldest people died at in different countries. The maximum age at death increased gradually at least from the 1950s until the 1990s, when it appeared to plateau.
    • “He isn’t surprised that Jeanne Calment, a French woman who died in 1997 at 122, still holds the world record of the oldest verified age at death. There are now hundreds of millions more people who have reached old age under optimal conditions—benefiting from clean water, antibiotics, improved treatments for top killers such as heart disease and cancer, and healthier lifestyles. 
    • “If lifespan had no limit, some of those centenarians would have broken Calment’s record by now, he argued.” 
    • “It seems this is the end,” Vijg said.

From the U.S. healthcare business front,

  • Beckers Clinical Leadership identifies the 94 emergency departments across our country that the Emergency Nurses Association has recognized “for their commitment to quality, safety and a healthy work environment.”
  • Per Fierce Pharma,
    • “Even through an onslaught of biosimilar launches that began early last year, AbbVie’s big-selling Humira has been able to retain most of its lucrative market. Still, though, the drug’s star power is on the decline.
    • “Biosimilar manufacturer Samsung Bioeps has tracked the impact of Humira biosim launches in its latest market report, finding that Humira’s slice of the market has dropped to 82%.
    • “Sandoz’ Hyrimoz, under its Cordavis co-label, is responsible for “most biosimilar gains,” according to the report. Cordavis is CVS Health’s new biosimilar subsidiary, which launched with Hyrimoz as its first product.
    • “Back in April, CVS Caremark removed branded Humira from its national commercial formularies, causing Hyrimoz prescriptions to skyrocket, analysts at Evercore ISI noted at the time. Through April 25, Hyrimoz was responsible for 82% of Humira biosimilar prescriptions, IQVIA data revealed. The successful launch has so far pushed Sandoz to revenue gains of 6% during the first quarter.”
  • The Wall Street Journal arranged for a palliative medicine doctor to write an essay about dying at home. It’s worth a look.
    • Research suggests that 70% of Americans want to die at home. More seem to be doing so, at least partly owing to the Covid-19 pandemic. In a study of where people died in 32 countries between 2012 and 2021, published in Lancet’s eClinicalMedicine in January, the authors found a rise in home deaths in most countries, including the U.S., during the pandemic, which they largely interpreted as progress.
    • The truth is more complicated. Now, 10 years into my career as a palliative medicine physician, I know that there is much more to a “good” death than its location. Presuming a home death is a success obscures important questions about the process: Did this person die comfortably? Did their caregivers have the resources and guidance they needed? Was dying at home a choice or simply the only option?

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Obesity, SDOH, Telehealth–

From Washington, DC,

  • Govexec informs us,
    • “The Senate on Thursday made progress on advancing bipartisan spending bills for fiscal 2025, though members of both parties acknowledged significant divisions remain between the two sides. 
    • “The chamber’s Appropriations Committee approved three of the 12 annual funding measures Congress must pass each year—those funding the departments of Agriculture and Veterans Affairs, as well as the legislative branch—in unanimous, 27-0 votes. While that marked a significant step forward in the fiscal 2025 process and an accomplishment that has eluded the panel’s House counterpart—which has advanced its bills to date only along partisan lines—the Senate could not come to a bipartisan agreement on how much money to allocate for the remaining nine funding measures.”
  • and
    • “The Senate on Wednesday voted 55-37 to confirm Anne Wagner as the third member of the Federal Labor Relations Authority, finally bringing the agency’s political leadership to nearly full strength.
    • “Similar to the National Labor Relations Board’s role overseeing collective bargaining in the private sector, the FLRA governs labor-management relations at federal agencies, with a three-member board that settles unfair labor practice complaints and other disputes between unions and management.” * * *
    • “Federal employee unions rejoiced at the news that the FLRA’s board was now fully staffed. The last 18 months of deadlock between [Colleen Duffy] Kiko and FLRA Chairwoman Susan Tsui Grundmann has meant the board could only rule in noncontroversial cases.”
  • The American Hospital Association News lets us know,
    • “The Senate Committee on Health, Education, Labor and Pensions held a hearing July 11 on medical debt. The AHA submitted a statement for the hearing that highlighted how the quality of insurance coverage is a driver of medical debt, saying that coverage for many patients is either insufficient or unavailable. The AHA discussed hospital and health system efforts offering financial and other assistance, and that hospitals absorb billions of dollars in losses for patients who cannot pay their bills, mainly due to inadequate commercial insurance coverage. To address the issue, the AHA urged Congress to restrict the sale of high-deductible health plans to individuals with the ability to afford the associated cost-sharing; prohibit the sale of health-sharing ministry products and short-term limited-duration plans that go longer than 90 days; and lower the maximum out-of-pocket cost-sharing limits, among other changes.”
    • That’s nuts, and it’s worth adding that all of the witnesses, except for one, were from the creditor side. Here’s a link to the American Enterprise Institute testimony.
  • The AHA News adds,
    • “The Centers for Medicare & Medicaid Services July 10 announced there will be 133 participants representing 772 practices for its new Making Care Primary Model. Participants in this voluntary model are from Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. The model, which began July 1 and will run through 2034, seeks to improve care management and care coordination, enable primary care clinicians to partner with health care specialists, and use community-based connections to address patients’ health needs as well as their health-related social needs such as housing and nutrition.”
  • and
    • “The Centers for Medicare & Medicaid Services recently released results of an air ambulance qualifying payment amount calculations audit on Aetna Health in Texas. The report found that Aetna used practices that did not comply with federal requirements, and strongly recommended corrective actions. Specifically, the report found that Aetna failed to “properly calculate the QPA by using claim paid amounts instead of contracted rates, and counting each claim as its own contracted rate, even when the claims were for the same amounts for the same item or service and to the same provider of air ambulance services.” Aetna may also be subjected to future audits.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Research into chronic conditions affecting women is significantly lacking, and the National Institutes of Health and other agencies should do more to investigate issues that lead to worse medical treatment for women, a new report from the National Academies of Sciences, Engineering and Medicine says.
    • “Women are disproportionately affected by chronic illnesses, including Alzheimer’s disease and depression, according to the study requested by NIH’s Office of Research on Women’s Health and published Wednesday.
    • “But inadequate research in women’s health “hinders a comprehensive understanding of the impact on women” of these and other chronic illnesses, the report’s authors write. Further research is needed, particularly for Black women, who are more likely to die of a chronic illness than White women, the study says.”
  • and
    • “Nearly 1 in 10 people infected with the coronavirus during pregnancy developed long covid, according to a study published Thursday in the journal Obstetrics and Gynecology.
    • “Thursday’s study, which highlights the consequences of the virus during pregnancy, suggests long covid is more prevalent among people infected while pregnant than in the population overall. As many as 7 percent of Americans report having symptoms associated with long covid, according to a 2022 report from the Centers for Disease Control and Prevention. Some surveys suggest a far higher incidence of long covid in the general population.” * * *
    • “I was initially surprised at the prevalence of long covid in this population,” said Torri Metz, one of the study’s lead authors and a maternal-fetal medicine specialist at University of Utah Health. “It really drew my attention to the fact I need to have this on my radar when I am seeing patients.”
  • NBC News informs us,
    • “A key mystery behind one of the most common autoimmune diseases may finally have an answer.
    • “Researchers at Northwestern Medicine and Brigham and Women’s Hospital say they’ve discovered a root cause of lupus, a disease that affects hundreds of thousands of people in the U.S. 
    • “Scientists have long suspected that a person’s genetics or hormones may predispose them to lupus, and that the disease may be triggered by environmental factors like a previous viral infection or exposure to certain chemicals.
    • “Now, a study published Wednesday in the journal Nature outlines a clear pathway for how the disease likely develops, pointing to abnormalities in the immune systems of people with lupus.”
  • Neurology Advisor points out,
    • “The prevalence of stroke has increased by 14.6% from 2011 to 2022 among individuals aged 18 to 44 and 15.7% among those aged 65 and younger in the United States, according to a report published in Morbidity and Mortality Weekly Report.
    • “Researchers assessed trends in stroke prevalence between 2011 and 2022, using data from the Behavioral Risk Factor Surveillance System (BRFSS), a state-based surveillance system administered to noninstitutionalized civilian adults in the US in collaboration with the Centers for Disease Control and Prevention (CDC). * * *
    • “Age-standardized prevalence of stroke increased from 2.7% in 2011 to 2013 to 2.9% in 2020 to 2022, marking a 7.8% (95% CI, 4.9%-10.8%) increase in overall stroke prevalence. The researchers noted the highest stroke prevalence (7.7%; 95% CI, 7.5%-7.9%) among individuals aged 65 and older and the lowest prevalence (0.9%; 95% CI, 0.8%-1.0%) among individuals aged between 18 and 44 years.
    • “Stroke was observed to be highest (5.3%; 95% CI, 4.7%-5.9%) among the American Indian or Alaska Native group and lowest among the Asian group (1.6%; 95% CI, 1.2%-2.0%).
    • “With regard to educational level, individuals with a high-school diploma had the highest stroke prevalence (5.2%; 95% CI, 4.8%-5.4%) and those with a college degree or higher had the lowest stroke prevalence (1.7; 95% CI, 1.6%-1.8%).”
  • STAT News relates,
    • “Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, viruses, excess body weight, alcohol drinking and more. Data was from 2019 in order to avoid the influence of the pandemic, when cancer diagnoses declined because of delayed care. The results were published in the American Cancer Society’s journal, CA: A Cancer Journal for Clinicians.” * * *
    • “In the study, alcohol was associated with seven cancers: oral cavity, pharynx, larynx, colorectum, and female breast, as well as squamous cell carcinoma in the esophagus, and hepatocellular carcinoma in the liver. Beyond those, “there is accumulating evidence” that alcohol can cause other cancers, such as pancreatic cancer, said lead author Farhad Islami, senior scientific director of cancer disparity research at ACS (which funded the study). 
    • “The increased risk is because of the alcohol in alcoholic beverages, not the type of beverage,” he said. A standard alcoholic beverage in the United States has about 14 grams of pure ethanol. That looks like one 12-ounce serving of 5% ABV beer, a 5-ounce serving of 12% ABV wine, 8-10 ounces of 7% ABV hard seltzer, or 1.5 ounces of 40% ABV liquor. Research suggests the higher a person’s consumption, the higher the risk of cancer.”
  • Here is a link to the NIH Director’s blog titled this week “Sequencing Technique Detects Earliest Signs of Genetic Mutations Underlying Cancer, Aging, and More”
  • The National Institutes of Health announced,
    • “Early findings from a small clinical trial provide evidence that a new cellular immunotherapy approach may be effective in treating metastatic solid tumors. In the trial, researchers from the National Institutes of Health (NIH) genetically engineered normal white blood cells, known as lymphocytes, from each patient to produce receptors that recognize and attack their specific cancer cells. These initial findings are from people with metastatic colorectal cancer who had already undergone multiple earlier treatments. The personalized immunotherapy shrank tumors in some patients and was able to keep the tumors from regrowing for up to seven months. The findings were published July 11, 2024, in Nature Medicine.” * * *
    • “Colon cancer is just one of many solid tumors the researchers are studying. The trial is still ongoing and includes patients with different types of solid cancers.
    • “It’s just the very beginning of converting normal lymphocytes into cells capable of treating the common solid cancers,” Dr. Steven A. Rosenberg, a co-leader of the study, said. “What this study shows is that it’s possible. Once you know it’s possible, you work to improve it.”
  • Here is a link to the All of Us Program’s latest Medical Minutes.

From the U.S. healthcare business front,

  • Beckers Hospital Review tells us,
    • “As more older adults opt for Medicare Advantage plans, reimbursement fights between hospitals and insurers are increasingly centered around those contracts.
    • “According to data shared with Becker’s by FTI Consulting, there were 20 reimbursement disputes between hospitals and insurers that made headlines somewhere in the country during the second quarter, the same amount as the first quarter and slightly lower than the same period in 2023, when 24 contract disputes were reported in national or local media.
    • “Notably, a record number of Q2 disputes (15 of 20) involved Medicare Advantage plans, and 30% of disputes failed to reach a timely agreement, meaning tens of thousands of patients were left without in-network coverage. FTI has tracked media reports regarding negotiations over reimbursement rates during each quarter since early 2022.”
  • BioPharma Dive reports,
    • “On Thursday, the pharmaceutical giant [Pfizer] said it is advancing a once-daily version of an experimental and closely watched medicine called danuglipron. Pfizer based the decision on results from a small clinical trial of healthy volunteers that’s been evaluating how the body interacts with danuglipron. Studies designed to find the optimal dose of the medicine are scheduled for later this year.
    • “Umer Raffat, an analyst at the investment firm Evercore ISI, speculates that with its update Thursday, Pfizer is “likely buying time” to see more data from a backup once-daily drug it’s been developing. “Candidly, the trial that just wrapped up never answered the question on” what dose would be effective enough to compete, he wrote in a note to clients.
    • “In that backdrop, the judicious thing to do from [the] Pfizer perspective was to not overcommit — and that’s exactly what they did today,” Raffat added. They “didn’t kill [danuglipron], they said it may move forward, but not right to [Phase 3].”
  • Beckers Payer Issues adds,
    • “As insurers continue to face major financial pressures related to covering weight loss drugs, many are steering more patients toward bariatric surgery to achieve similar results.
    • “Insurance companies are seeing that they’re getting more reliable outcomes and savings in the long run if they pay for someone to have bariatric surgery,” Christine Ren Fielding, MD, told Becker’s. Dr. Ren Fielding is a professor of surgery at NYU School of Medicine, the director of the NYU Langone Weight Management Program and chief of the system’s division of bariatric surgery.
    • “If you’re a responder to appetite control caused by a GLP-1, then there’s another treatment option that will do exactly the same thing: bariatric surgery. That includes Lap-Band, sleeve gastrectomy, and gastric bypass,” she said. “Bariatric surgery is the old-fashioned way. Insurers are now putting up barriers for people who want to be covered for GLP-1s and taking down barriers for people who want to have surgery.”
  • STAT News informs us,
    • “The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant.
    • “The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.”

Monday Roundup

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

From Washington, DC,

  • Roll Call lets us know,
    • “Senate Appropriations Committee leaders have agreed to add $34.5 billion in emergency spending to their fiscal 2025 bills on top of levels agreed to in last year’s debt limit negotiations, sources familiar with the talks said Monday. 
    • “Under the pact between Senate Appropriations Chair Patty Murray, D-Wash., and ranking member Susan Collins, R-Maine, defense accounts would receive an extra $21 billion in emergency spending while nondefense programs would get $13.5 billion.” 
  • Taking a gander at reginfo.gov led the FEHBlog to discover that on July 1, the final version of the simply infeasible federal mental health parity rule changes was submitted to OIRA for its review.
  • In yesterday’s post, the FEHBlog called attention to the new CMS GUIDE program. The post noted that program details would be released in early July. What do you know? Those details were posted today. The American Hospital News tells us,
    • “The Centers for Medicare & Medicaid Services July 8 announced over 400 participants in a new model focused on improving dementia care. The Guiding an Improved Dementia Experience (GUIDE) Model began July 1 and seeks to reduce strain on unpaid caregivers as well as offer care coordination and management, caregiver education and support, and respite services. CMS will also test an alternative payment for participants delivering key support services to people with dementia, including comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. People with dementia and their caregivers will have access to a care navigator to help them access services and support, including clinical services and non-clinical services such as meals and transportation through community-based organizations.”
  • The HHS Inspector General posted an impact brief on Medicare Advantage program fraud involving its risk adjustment program. The Wall Street Journal published an article the same type of fraud today.
  • STAT News informs us,
    • “The Biden administration has appealed a decision in which a federal court jury last year sided with Gilead Sciences over the rights to a pair of groundbreaking HIV pills — and at least $1 billion in royalties may be at stake.
    • “At issue is a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
    • “The U.S. Centers for Disease Control, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company refused to reach a licensing agreement despite several attempts to strike a deal.” * * *
    • “U.S. District Court Judge Maryellen Noreika narrowed the Gilead victory last March when she set aside the jury finding that CDC patents were not infringed. So the appeal filed by the U.S. Department of Justice — on behalf of HHS — refers to the only portion of the jury finding that remains, which is that the patents were invalid.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health. The agency is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products.” * * *
    • “Specifically, the revised draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers, sets out a policy that supports companies that issue certain kinds of internet-based communications (“tailored responsive communications”) to address internet-based misinformation about or related to their approved/cleared medical products when that misinformation is created or disseminated by an independent third party. For example, a company might choose to use this type of communication when a celebrity, healthcare provider or influencer, not acting on behalf of the company, posts false, inaccurate and/or misleading representations of fact about the company’s approved/cleared medical product on social media. Additionally, this revised draft guidance provides companies with many examples that illustrate the types of misinformation found online that a company might choose to address with a tailored responsive communication, along with some considerations relevant to the current digital information environment.”
  • Govexec tells us,
    • “The Office of Personnel Management lost a small modicum of ground in its fight to reduce the backlog of pending retirement claims from federal employees as the agency’s backlog of cases inched back over 15,000.
    • “In June, OPM received 6,919 new retirement requests from departing federal workers, a slight increase over the 6,751 claims it received the previous month. But the agency’s pace in processing those claims fell precipitously, completing only 5,614 claims last month compared to the 8,793 it processed in May.
    • “That deficit led to OPM’s overall backlog of pending claims to climb from 14,035—an eight-year low—in May to 15,340 at the end of June. Consequently, the monthly average processing time for a retirement application ticked up four days, from 60 in May to 64 last month, though measured since the beginning of fiscal 2024, the average processing time has remained static at 61 days for four months running.”
  • The U.S. Preventive Services Task Force is celebrating its 40th anniversary. The FEHBlog is reminded that the FEHB Act will be 65 years old on September 28, 2024.

From the public health and medical research front,

  • The New York Times reports,
    • “The process for diagnosing a child with autism heavily relies on a parent’s description of their child’s behavior and a professional’s observations. It leaves plenty of room for human error.
    • “Parents’ concerns may skew how they answer questionnaires. Providers may hold biases, leading them to underdiagnose certain groups. Children may show widely varying symptoms, depending on factors like culture and gender.
    • “A study published Monday in Nature Microbiology bolsters a growing body of research that suggests an unlikely path to more objective autism diagnoses: the gut microbiome.
    • “After analyzing more than 1,600 stool samples from children ages 1 to 13, researchers found several distinct biological “markers” in the samples of autistic children. Unique traces of gut bacteria, fungi, viruses and more could one day be the basis of a diagnostic tool, said Qi Su, a researcher at the Chinese University of Hong Kong and a lead author of the study.”
  • The American Medical Association tells us what doctors wish their patient knew about heat stroke.
  • The Wall Street Journal discusses the right and wrong ways for people to snack.
    • “America is a nation of snackers. A lot of us are doing it wrong. 
    • “Noshing outside of traditional mealtimes isn’t inherently bad. A snack can stave off hunger, boost energy, provide important nutrients and keep us from overeating later. But snacking can also lead us to eat extra calories and overdo it on sodium, added sugars and saturated fats, which can raise our risk of heart disease and obesity. 
    • “How to snack better? Reach for food combinations that keep you fuller longer: Pair carbs like apple slices with protein and fats, like peanut butter. Or try yogurt with berries. Then plan your snack times, and watch out for the minefield that is evening snacking.”
  • The Washington Post and Consumer Reports offer information about “an aggressive tick species spreading across the U.S. Lone star ticks don’t spread Lyme disease, but they can transmit other serious diseases and are linked to a mysterious meat allergy. And the threat is growing.”
    • “Lone star ticks have long been firmly established in the Southeastern United States. In recent decades, however, their numbers have been increasing in Midwestern and Northeastern states. Between 2017 and 2021, according to CDC data, nearly half of reported ehrlichiosis cases were in five states: Arkansas, Missouri, New York, North Carolina and Tennessee.”
  • The CDC has posted FAQs on infertility. “This page has definitions and frequently asked questions related to infertility. It has important information about infertility, including common misconceptions, risk factors, and treatment options.”
  • Beckers Hospital Review points out,
    • “GLP-1 drugs such as Ozempic and Wegovy may lower the risk of developing certain obesity-related cancers, according to a new study from researchers at Case Western Reserve University in Cleveland. 
    • “Researchers found people with type 2 diabetes who were being treated with the medications were significantly less likely to develop 10 of 13 obesity-associated cancers than those taking insulin, according to the findings published July 5 in JAMA Network Open. The retrospective study is based on an analysis of the medical records of over 1.6 million type 2 diabetes patients from 2005 to 2018.
    • “The risk was reduced by more than half for gallbladder cancer, meningioma, pancreatic cancer and hepatocellular carcinoma. Esophageal, colorectal, endometrial, ovarian, multiple myeloma and kidney were among the other cancers for which there was a significant risk reduction. The study did not find a difference in cancer risk reduction among those treated with GLP-1s compared with those taking metformin, an older diabetes drug. 
    • “In an interview with Bloomberg, Arif Kamal, MD, chief patient officer at the American Cancer Society and who was not involved in the research, called the new evidence on GLP-1s “compelling.”
  • Per Fierce Pharma,
    • “In examining the electronic records of more than 18,000 overweight or obese adults in the United States, health data analytics company Truveta found that Lilly’s tirzepatide helped patients lose more weight than Novo’s semaglutide, with the effects growing over time.
    • “Results of the study, which looked at data from May of 2022 and September of 2023, were published Monday in the JAMA Internal Medicine monthly review.
    • “”After use of tirzepatide for three months, patients lost an average of 5.9% of their body weight compared to 3.6% for semaglutide. Over a year’s time, those on tirzepatide lost an average of 15.3% of their body weight compared to 8.3% for semaglutide users.
    • Additionally, tirzepatide patients were much more likely to lose 15% of their body weight than those using semaglutide. While 42% of those on tirzepatide reached the benchmark after one year of treatment, only 18% of those on semaglutide could say the same. 
    • “Lilly’s tirzepatide is the active ingredient found in its diabetes product Mounjaro and its obesity treatment Zepbound, while Novo’s semaglutide is the compound used to make its diabetes blockbuster Ozempic and its obesity follow-on Wegovy.
    • “Importantly, the Truveta study looked at the drugs that are approved for diabetes. The authors noted that “future studies are needed to compare versions labeled for weight loss.”
  • Per an NIH press release,
    • “A series of experiments with highly pathogenic H5N1 avian influenza (HPAI H5N1) viruses circulating in infected U.S. dairy cattle found that viruses derived from lactating dairy cattle induced severe disease in mice and ferrets when administered via intranasal inoculation. The virus from the H5N1-infected cows bound to both avian (bird) and human-type cellular receptors, but, importantly, did not transmit efficiently among ferrets exposed via respiratory droplets. The findings, published in Nature, suggest that bovine (cow) HPAI H5N1 viruses may differ from previous HPAI H5N1 viruses and that these viruses may possess features that could facilitate infection and transmission among mammals. However, they currently do not appear capable of efficient respiratory transmission between animals or people.”
  • MedPage Today lets us know,
    • “Extended-release 7-day injectable buprenorphine was safe and tolerable for most patients who had minimal-to-mild opioid withdrawal, a nonrandomized trial found.
    • “Among 100 adult patients with minimal-to-mild opioid withdrawal scores who were given a 24-mg dose of extended-release buprenorphine, only 10 people (10%, 95% CI 4.9%-17.6%) saw a 5-point or greater jump in withdrawal symptoms within 4 hours of injection, reported Gail D’Onofrio, MD, of the Yale School of Medicine in New Haven, CT, and colleagues.” * * *
    • “The study examined whether patients with untreated opioid use disorder (OUD) and minimal-to-mild withdrawal could tolerate a 7-day dose of buprenorphine. Patients with OUD typically aren’t treated with medication until they are in significant withdrawal, due to fear of precipitated withdrawal. For that reason, “[n]o one has ever even attempted to give buprenorphine in that [0 to 7] range,” D’Onofrio said.” * * *
    • “[This is a real game-changer for emergency physicians and clinicians, even in the clinic, who would be able to induce people on buprenorphine much earlier than they previously could have,” D’Onofrio said.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY has agreed to buy biopharmaceutical company Morphic Holding MORF for $3.2 billion in a deal that bolsters the drugmaker’s immunology pipeline.
    • “Eli Lilly on Monday said it would pay $57 a share for Morphic, a 79% premium to Friday’s closing price of $31.84 for the Waltham, Mass., company.
    • “Morphic is developing therapies for the treatment of serious chronic diseases, with a lead program targeting the inflammatory bowel diseases ulcerative colitis and Crohn’s disease.
    • “Eli Lilly late last year won U.S. Food and Drug Administration approval of its Omvoh treatment for moderately to severely active ulcerative colitis in adults.
    • “Indianapolis-based Eli Lilly said it expects to complete the acquisition, which isn’t subject to any financing conditions, in the third quarter.”
  • Modern Healthcare relates,
    • “More than half of people surveyed would feel just as safe getting hospital-level care at home as they would in a facility, according to the University of Southern California’s Schaeffer Center for Health Policy and Economics.
    • “Healthcare systems across the country are placing big bets on hospital-at-home programs, pushing access to more rural communities and lobbying state Medicaid programs to reimburse for the service. A Centers for Medicare and Medicaid Services waiver reimbursing for acute care at home expires at the end of this year, but bipartisan members of Congress are backing legislation that would provide Medicare reimbursement for another five years. More than 330 hospitals across 37 states offer hospital-level care at-home programs through the CMS Acute Hospital Care at Home waiver.” * * *
    • “The survey did not require participants to have prior experience with hospital-level care at home or knowledge of the service. It did provide participants with a brief explanation of how hospital-at-home programs operate.”
  • Per Fierce Healthcare,
    • “A recent proposal to report prior authorization to insurance plans through CPT codes was withdrawn at the eleventh hour when its physician advocate made an unexpected discovery: For certain codes and in very narrow circumstances, the prior auth requirements were already in place.
    • “Alex Shteynshlyuger, M.D., director of urology with New York Urology Specialists, had previously brought forward a time-based proposal that would ensure physicians are compensated for time spent on prior auth claims. He believed the changes would also reduce the number of claim requirements imposed by plans and limit the amount of appeals and could lead to better patient outcomes.
    • “Following the proposal, however, the American Medical Association (AMA) informed Shteynshlyuger that prior authorization is already explicitly mentioned in official procedure descriptions for half a dozen CPT codes. This required Shteynshlyuger to withdraw the proposal so he could revise and resubmit at a later date.
    • “Each CPT code includes a short description detailing the type of visit or examination. Longer descriptions—where the prior auth mentions were contained—are also stored in databases that can be purchased, but those are rarely encountered.
    • “As a matter of fact, I’ve never seen the long description in my lifetime,” said Shteynshlyuger.”
  • and
    • “Nearly 5 million fewer people delayed care from 2019 to 2022, a study from the Urban Institute with funding from the Robert Wood Johnson Foundation revealed.
    • “The study shows 4.75 million non-elderly Americans skipped necessary medical care, dropping from 12.1% to 9.7% in 2022.
    • “For families below 138% of the federal poverty line, there was a 27% reduction in cost barriers. A 19% reduction was evident for families between 138% and 249% of the federal poverty line.
    • “Researchers say these outcomes are a direct result of the Medicaid continuous coverage requirements and enhanced tax credits.
    • “Our findings show significant improvements in health insurance coverage and healthcare access under federal and state policy changes enacted during the public health emergency,” said Michael Karpman, principal research associate at the Urban Institute, in a statement. “The continued unwinding of the Medicaid continuous coverage requirement and the potential expiration of enhanced Marketplace subsidies after 2025 could make these gains in coverage and access difficult to sustain.”

Friday Factoids

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

From Washington, DC,

  • Federal News Network tells us,
    • “Although the federal workforce on the whole is relatively diverse, much of that diversity is condensed on the lower end of the General Schedule.
    • “It’s a demographic trend that has persisted for years, but there may be a few early signs of change, according to a July 1 workforce report from the Partnership for Public Service that uses data from FedScope.
    • “Data from fiscal 2023 shows that 60% of the federal workforce is white, 19% of federal employees are Black and 10% are Hispanic. By comparison, for the nationwide workforce, 76% of employees are white, 13% are Black and 19% are Hispanic.
    • “Breaking down diversity by GS level, the Partnership’s data report shows that white federal employees make up a much larger portion of the workforce at GS-7 and up through the Senior Executive Service, taking up many mid- and top-level technical roles as well as many supervisory positions.” * * *
    • “The long-time workforce trend is beginning to change, albeit slowly, the Partnership said. Between 2022 and 2023, the percentage of people of color in the SES rose 1%, from 25% to 26%.
    • “Similar trends occur when breaking down the workforce by gender. Overall, women make up 45% of the federal workforce, while men comprise 55%. But again, men make up a larger portion of higher-level GS positions as well as SES roles. There appears to be a similar trend toward a more equal balance between men and women in the SES, the Partnership’s report showed.”
  • STAT News informs us,
    • “A federal judge ruled against Boehringer Ingelheim’s challenge to the new Medicare drug price negotiation program, handing the pharmaceutical industry its latest in a string of legal losses.
    • “The company had argued before the U.S. District Court of Connecticut that the drug pricing law was unconstitutional under four different parts of the Constitution, and also that Medicare officials had violated procedural laws. Judge Michael Shea ruled against Boehringer Ingelheim on each point in a decision published late Wednesday.
    • “Boehringer Ingelheim did not immediately respond to a request for comment on the ruling. The company’s diabetes drug Jardiance was one of the first medicines selected for the negotiation program.
    • “Federal judges have also ruled against drugmakers including AstraZeneca, Bristol Myers Squibb, and Johnson & Johnson, and trade groups including the brand-drug lobby PhRMA and the U.S. Chamber of Commerce in their lawsuits challenging the law.”
  • HR Dive lets us know,
    • “A Texas federal judge on Wednesday granted a tax services firm’s motion for a preliminary injunction of the Federal Trade Commission’s nationwide ban on noncompete agreements in employment contracts and has stayed its effective date for the plaintiffs.
    • “Judge Ada E. Brown of the U.S. District Court for the Northern District of Texas held that FTC violated the Administrative Procedure Act and exceeded its statutory authority by issuing the ban, which she said has a “substantial likelihood” of being found arbitrary and capricious.
    • “Brown said the injunction is limited in scope to the plaintiffs and plaintiff-intervenors named in the suit; it is not a nationwide injunction. She added that the court would rule on the merits of the agency’s action on or before Aug. 30, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control announced today,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • “COVID-19
      • “Some areas of the country are experiencing consistent increases in COVID-19 activity, including increases in COVID-19 test positivity and emergency department visits and increases in rates of COVID-19–associated hospitalizations among adults 65+ at several sites. However, nationally COVID-19 activity remains low. Recent increases in activity level are from very low levels in April and May 2024, when they were lower than at any time since March 2020. CDC will continue to closely monitor trends in COVID-19 activity.
    • “Influenza
    • “RSV
      • Nationally, RSV activity remains low.
    • “Vaccination
  • The New York Times adds,
    • “Many of us associate Covid with respiratory issues. But some people who get sick with the virus never experience a sore throat, coughing or body aches, said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco. Certain people end up feeling more like they have food poisoning than anything else.
    • “That’s because coronavirus is “like throwing a bomb in your body,” said Dr. Ken Cadwell, a professor of medicine at the University of Pennsylvania who studies how Covid affects the gut. “You’re going to feel that in multiple different organs, not just the lungs.”
    • The article offers tips on how to spot Covid symptoms.
  • The Washington Post discusses cancerphobia in an era when cancer deaths have been falling and provides cancer prevention tips.
  • The Food and Drug Administration announced,
    • “On Wednesday, the FDA updated the advisory for the investigation of Salmonella illnesses linked to cucumbers. The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Salmonella Africana and Salmonella Braenderup infections with 449 illnesses in 31 states and the District of Columbia.
    • “While originally reported as two separate outbreaks, CDC and FDA combined these two outbreak investigations as they shared several similarities, including when and where illnesses occurred, the demographics of ill people, and the foods they reported eating before they became sick.
    • “Laboratory, epidemiological, and traceback data have determined that cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, are a likely source of illnesses in this outbreak; however, this grower does not account for all the illnesses in this outbreak. Bedner Growers, Inc.’s cucumber growing and harvesting season is over. There is no product from this farm on the market and likely no ongoing risk to the public.”
  • Per MedPage Today,
    • “GLP-1 receptor agonists lowered the risk of several obesity-associated cancers, a retrospective analysis of electronic health records suggested.
    • “Compared with insulin, GLP-1s were associated with a lower risk for developing 10 of 13 cancers in people with type II diabetes, reported Nathan Berger, MD, of the Case Western Reserve University in Cleveland, and colleagues in JAMA Network Open.
    • “No decrease in cancer risk was associated with GLP-1 receptors compared with metformin.
    • “This study adds to the growing body of evidence supporting the pleiotropic effects of GLP-1 receptor agonists on cancer prevention, including obesity-associated cancers,” co-author and medical student Lindsey Wang, also of Case Western Reserve University School of Medicine, told MedPage Today. (Berger passed away before the study was published.)
  • Per Healio,
    • “Many women aged 75 years and older are aware of the importance of breast cancer screening and desire to continue screening regardless of health status or age, according to a scoping review published in BMC Women’s Health.
    • “Very few studies have been undertaken to understand the motivations of women to screen or to establish screening participation rates among women aged 75 and older,” Virginia Dickson-Swift, PhD, senior research fellow at the Violet Vines Centre for Rural Health Research at La Trobe Rural Health School at La Trobe University, Australia, and colleagues wrote. “This is surprising given that increasing age is recognized as a key risk factor for the development of breast cancer, and that screening is offered in many locations around the world every 2 years up until age 74 years.” * * *
    • “Decision aids may be effective in improving knowledge of the benefits and harms of breast screening as many women reported poor knowledge, according to the authors. A pilot study of eight women in the U.S. utilizing decision aids demonstrated that 62.5% of women planned to continue receiving mammography. In this study, agreeing that their physician would recommend mammography dropped from 80% to 62.5% after exposure to the decision aid. These results suggest that decision aids might result in fewer women continuing breast cancer screening beyond age 75 years.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Pharmaceutical giant AbbVie paid health care providers roughly $145.7 million last year to promote its drugs, according to a STAT analysis of newly released government data.”
    • “The massive sum spent by AbbVie, the maker of the mega blockbuster anti-inflammatory drug Humira, is the most a pharmaceutical company has spent on marketing to doctors since such data became available in 2017. The figure includes compensation for consulting and other services like speaking fees, lodging and travel for doctors, and meals, as well as a small number of payments made directly to hospitals.
    • “The payments, made public by the Centers for Medicare and Medicaid Services, provide an insight into AbbVie’s marketing in the immediate aftermath of the company losing its monopoly on Humira, which dominated the company’s balance sheets for the better part of the last two decades. The payments show that the company is being far more aggressive in targeting doctors than competitors of comparable size.
    • “Pfizer, whose revenues are on par with AbbVie’s, spent roughly $32 million last year. Merck spent about $22 million. These totals don’t include subsidiaries that are reported separately from their parent companies.”
  • Managed Care Executive assures us that notwithstanding this colossal effort, biosimilars to Humira are gaining market share due to PBM actions and legal changes.
  • PCMA points out various PBM efforts to reach out to the rural community.
  • The Wall Street Journal suggests that the Walmart model does not work in healthcare.
    • “To put it bluntly, primary care is hard,” said Stephanie Davis, an analyst at Barclays. The problem for Walmart, said Craig Garthwaite, a strategy professor at Northwestern University, is that in medicine you can’t really build economies of scale by driving the costs of such things as purchasing and advertising down to charge lower prices and gain market share. In a doctor’s office, your big-ticket costs are the people: A family physician might make something like $250,000, while a nurse practitioner is paid around $150,000. 
    • “None of that is scalable,” he said. “Each one of those doctors can only work eight to 10 hours a day. So you can’t run the business the same way.” * * *
    • “That doesn’t mean that there isn’t plenty of money to be made from the doctor’s office. But the value won’t come from charging a flat fee for, say, an annual checkup. Instead, for large companies, the doctor needs to be a conduit for capturing value elsewhere. Big hospital systems have been at this for a long time. They acquire or join with doctor groups to control patient traffic to higher-margin procedures. A primary-care doctor controlled by New Jersey-based Atlantic Health System, for instance, might refer a patient to a urologist within that same system.  
    • “That approach really hasn’t helped patients. Instead, it has raised the cost of care, giving giant hospitals billions of dollars in additional revenue.” 
  • Similarly, mHealth Intelligence examines the limitations of the current telehealth market.

Midweek Update

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

From Washington, DC,

  • The Michael J. Fox Foundation tells us
    • “On July 2, 2024, President Biden signed the National Plan to End Parkinson’s Act into law.”
    • “Now that the bill has been signed into law, the U.S. Department of Health and Human Services (HHS) will establish the National Parkinson’s Project, a first-ever federal initiative to prevent and cure Parkinson’s disease, treat its symptoms and slow or stop its progression. It will also establish a federal advisory council that will provide recommendations and guidance for making progress against Parkinson’s disease and atypical parkinsonisms.”
  • A Labor Department press release informs us,
    • “The U.S. Department of Labor has released a proposed rule with the goal of protecting millions of workers from the significant health risks of extreme heat. If finalized, the proposed rule would help protect approximately 36 million workers in indoor and outdoor work settings and substantially reduce heat injuries, illnesses and deaths in the workplace.”  * * *
    • “The proposed rule would require employers to develop an injury and illness prevention plan to control heat hazards in workplaces affected by excessive heat. Among other things, the plan would require employers to evaluate heat risks and — when heat increases risks to workers — implement requirements for drinking water, rest breaks and control of indoor heat. It would also require a plan to protect new or returning workers unaccustomed to working in high heat conditions.” * * *
    • “Employers would also be required to provide training, have procedures to respond if a worker is experiencing signs and symptoms of a heat-related illness, and take immediate action to help a worker experiencing signs and symptoms of a heat emergency. ” 
  • An HHS press release adds,
    • “FEMA and the U.S. Department of Health and Human Services (HHS) are encouraging everyone to plan and act now to protect themselves against the dangers of heat-related illness and deaths. Extreme heat is the leading cause of death among all weather-related hazards in the U.S., but this health impact is largely preventable. The Centers for Disease Control and Prevention (CDC) estimates that at least 1,220 people in the U.S. are killed by heat events each year. Older adults, young children, and those individuals with health conditions, such as asthma or diabetes are at a greater risk for heat-related illnesses.” * * *
    • A Full List of Heat and Health Resources That Can Help: The list can be found at 2024 HHS Resources on Heat and Health – PDF.
  • The Washington Post lets us know,
    • “The Food and Drug Administration has decided to revoke its authorization for the use of a stabilizer for fruity and citrus-flavored food and beverages, known as brominated vegetable oil (BVO), because it is unsafe.
    • “The agency concluded that the intended use of BVO in food is no longer considered safe,” the agency said in a statement Tuesday. It added that based on studies conducted in collaboration with the National Institutes of Health, it found that BVO has “the potential for adverse health effects in humans.”
    • “The vegetable oil is modified with bromine, a natural chemical element that can be used as an alternative to chlorine in swimming pools and is often used as a fire retardant. It has also been used in sedatives.”
    • “BVO is an ingredient in a handful of sports drinks and sodas, but according to the FDA, “today, few beverages in the U.S. contain BVO.” Sugary soda consumption in the United States has also been falling for more than two decades. Perhaps the best-known drink in the United States that still contains BVO is Sun Drop citrus soda, as well as some store-brand orange, pineapple and citrus-flavored sodas from Giant, Food Lion, Walmart and others.”
  • Reg Jones, writing in FedWeek, discusses the leave without pay program for federal employees.
  • BioPharma Dive points out five FDA decisions that may be issued in the third quarter of 2024.
  • Federal News Network reports,
    • “With a net gain of more than 80,000 civilian employees during fiscal 2023, the federal workforce posted yet another year of growth.
    • “Between 2019 and 2023, more than 140,000 employees joined the civil service, an increase of about 7%, according to data that the non-partisan, non-profit Partnership for Public Service compiled and released this week.
    • “The majority of the growth in the past couple of years occurred in 2023 alone — the federal workforce grew by 4% in just that one year, the Partnership said. The latest increase brings the grand total of full-time federal employees to just over 2 million.
    • “These professionals play a crucial role in protecting our national security, promoting public health, driving economic development and more,” the Partnership wrote in its data report, published Monday. “They are a fundamental part of a well-functioning government.”

From the public health and medical research front,

  • The Washington Post reports,
    • “Three years after President Biden hoped July 4, 2021, would mark the country’s independence from covid, the coronavirus is still here as new variants drive yet another summer uptick.
    • “The country is indeed free from the waves of mass death that once overwhelmed hospitals and morgues, as well as policies restricting how Americans had fun and went to school and work.
    • ‘But just as the American Revolution didn’t fully eradicate the British threat (see: the War of 1812), the coronavirus remains a public health issue, inflicting milder but disruptive illness on most people and posing a greater danger to the medically vulnerable.” * * *
    • “Experts say wastewater data is best interpreted as a way of understanding which way the virus is trending.
    • “We have consistently seen over the past three years that there is a winter surge and there is also a summer surge,” Marlene Wolfe, program director for WastewaterSCAN, a private initiative that tracks municipal wastewater data, and an assistant professor of environmental health at Emory University’s Rollins School of Public Health. “Right now, we are waiting to see whether we actually will see a downturn over the next couple of weeks and we’ve hit the peak here, or whether those levels will actually go up.”
  • GovCIO notes,
    • “Health policy officials are targeting new elements for U.S. Core Data for Interoperability (USCDI) standards to help researchers and developers speak the same language for technology around cancer care and treatment.
    • “How do we think about these additional data elements to solve particular use cases so that our federal agency partners can programmatically build on that for the programs that they have and it allows everyone to be tethered and based on what the health care delivery system already supports?” National Coordinator for Health IT Micky Tripathi, who also recently assumed a dual role as acting chief AI officer at the Department of Health and Human Services, said at a May summit.
    • “Health agencies are building a pipeline of cancer data elements for USCDI. Tripathi said ONC partners have already agreed upon the first set of data elements that aligns with reporting requirements. Agencies involved include ONC, the National Cancer Institute (NCI), the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS).”
  • STAT News discloses,
    • “A new observational study on Wednesday reported for the first time a potential link between Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy and an eye condition that can cause vision loss.
    • “After hearing anecdotes of patients on the diabetes and obesity drugs experiencing nonarteritic anterior ischemic optic neuropathy, or NAION, researchers at Massachusetts Eye and Ear analyzed data from a registry of patients at their institution to see if there was a broad trend.
    • “Among 710 patients with type 2 diabetes, there were 17 cases of NAION in patients prescribed semaglutide (the scientific name of both drugs). This translated to a cumulative rate of 8.9% over three years. That compares with six cases in patients prescribed non-GLP-1 diabetes drugs, calculated as a cumulative rate of 1.8%. Through statistical analyses, the researchers estimate that there was a 4.28 times greater risk of developing the condition in patients prescribed semaglutide, according to the study, published in JAMA Ophthalmology.
    • “Studying 979 patients who had overweight or obesity, researchers found 20 cases of NAION in people prescribed semaglutide, calculated as a cumulative rate of 6.7%. In comparison, there were three cases in people prescribed non-GLP-1 obesity drugs, calculated as a cumulative rate of 0.8%. The researchers estimate that there was a 7.64 times greater risk of developing the condition in patients prescribed semaglutide.”
  • Per a National Institutes of Health press release,
    • “Results from a large study supported by the National Institutes of Health show that protein analyses taken during the first trimester of pregnancy did not improve predictions for identifying people at risk for experiencing conditions related to having high blood pressure during pregnancy. Since there is an urgent need to better predict people at risk for developing conditions related to having high blood pressure during pregnancy, also called hypertensive disorders of pregnancy, researchers have been studying if proteins taken from blood or urine samples could provide this insight. This study provides the largest data to date based on using protein analyses from blood samples during early pregnancy.
    • “For this study, researchers analyzed 6,481 proteins from 1,850 study participants who had a first pregnancy between 2010 and 2013. Participants provided a blood sample during the study enrollment and had study check-ins during their second and third trimesters, after delivery, and two to seven years after their pregnancy. The protein analysis was used in different modeling equations to assess if proteins or their combinations with clinical data, such as maternal age and cardiovascular disease risks, during early pregnancy could provide clues for the 753 participants who experienced a hypertensive disorder of pregnancy. The conditions assessed included gestational hypertension, marked by high blood pressure that typically develops after 20 weeks of pregnancy, and preeclampsia, a significant rise in blood pressure after 20 weeks of pregnancy that can damage organs and is marked by elevated levels of protein in the urine.
    • “The prediction models, which included three different types of assessments, did not significantly improve risk predictions for these events. If the models did show predictive ability, they did not drastically improve criteria physicians currently use to assess risks. These criteria currently include risk factors such as having obesity, diabetes, high blood pressure, or a baby later in life.”
  • The NEJM Catalyst offers an article
    • “highlight[ing] the persistent challenges and opportunities surrounding the impact of value-based care (VBC) arrangements on patient safety, despite the widespread adoption of VBC models. In the context of recent declines in patient safety, the authors contend that this crucial component of health care value has not received sufficient attention in most VBC contracts.
    • “The authors propose strategies for how payers can integrate patient safety measures into VBC contracts and align financial incentives with quality performance, drawing on the example of Elevance Health’s initiative, the Quality-In-Sights: Hospital Incentive Program. In this program, patient safety measures comprise 80% of the overall score.
    • “The program suggests that a sustained and productive collaboration between payers and providers offers potential for integrating patient safety measures into VBC models to drive clinical improvements and financial efficiencies, but it requires commitment from all stakeholders in the health care ecosystem.”
  • Per MedPage Today,
    • “E-cigarette use among individuals eligible for [USPSTF recommended] lung cancer screening was independently associated with a reduced likelihood of screening, a cross-sectional study of U.S. adults revealed.” * * *
    • “Former smokers who use e-cigarettes remain at increased risk of lung cancer and should be targeted by interventions to improve adherence to LCS [lung cancer screening],” Wang and co-authors concluded.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “More than two dozen Medicare Advantage insurers received higher quality marks for 2024, based on a STAT review of new data released July 2 by the federal government.
    • “Ten health insurance companies, including UnitedHealth Group’s UnitedHealthcare and CVS Health’s Aetna, received critical upgrades in some of their offerings that will allow them to earn hundreds of millions of dollars in extra taxpayer-funded bonuses.”
  • Beckers Payer Issues offers more details on the plans that got a boost to five stars due to the CMS action.
  • Beckers Payer Issues also informs us,
    • “Walmart has held talks with Humana about a potential sale of its shuttered Walmart Health clinics, Fortune reported July 2. 
    • “Multiple sources familiar with the situation told Fortune that Walmart has held discussions with potential buyers for its clinics, including Humana, the only potential buyer named in the report. It is unclear if talks are ongoing, according to the publication.”
  • The Wall Street Journal reports,
    • “GSK struck a deal to buy the rights to CureVac’s CVAC -6.59%decrease; red down pointing triangleCovid-19 and flu vaccines for up to 1.45 billion euros ($1.56 billion), in a bid to regain ground lost to newcomers to the vaccine market during the pandemic.
    • “The deal bolsters the U.K. pharmaceutical company’s vaccine portfolio at a time when bird-flu concerns are boosting demand. Vaccines accounted for roughly a third of GSK’s sales last year.
    • “GSK’s deal with CureVac follows in the footsteps of a vaccine licensing agreement between Sanofi and Novavax in May valued at up to $1.4 billion.
    • “Both GSK and Sanofi were among the biggest makers of vaccines before the pandemic, but fell behind rivals and new entrants that launched shots based on messenger RNA, or mRNA, technology as Covid-19 turbocharged demand. The mRNA-based vaccines that were widely used to combat Covid-19 use messenger ribonucleic acid instead of an actual bacteria or virus in the production process.”
  • Plan Advisor lets us know,
    • “Many employers are spending money on benefits that do not match the objectives of their workforce, based on a recent survey by Payroll Integrations, which connects payroll provider programs with employers.
    • “According to Payroll Integrations’ recent survey, summarized in the 2024 State of Employee Financial Wellness Report, only 18% of workers expressed interest in the programs their employers are now funding. While 41% of employers indicated they intend to increase their spending on financial education and planning services, workers would rather see their employers make larger investments in retirement plans (43%) and health insurance (54%).
    • “Employees are feeling the financial pressure from inflation, higher costs of living and the rise of insurance costs and now, more than ever, employers feel a responsibility to step in to help support their financial well-being,” said Doug Sabella, Payroll Integrations’ CEO, in a release that accompanied the report. “But there’s a clear disconnect between what employers think employees want in terms of financial wellness offerings and benefit programs and what employees feel they need to make a difference.”
    • “While workers in Generation Z want their companies to make lifestyle benefits top priority, older generations place more emphasis on health care and retirement, Payroll Integrations found. Baby Boomers ranked pensions as the most essential benefit, Gen X and Gen Y workers selected additional compensation, Millennials prioritized health savings accounts, and Gen Z employees picked lifestyle compensation.”

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, SCOTUS, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Fierce Healthcare reports,
    • “The House Ways and Means Committee advanced bipartisan legislation on Thursday [June 28] that would grant Medicare coverage to novel medical technologies for four years while the Centers for Medicare & Medicaid Services (CMS) makes a national coverage determination. 
    • “The new version of the bill that was voted on by Ways and Means reduces the cost of the bill by 75% of the version that the House Energy and Commerce Committee voted favorably on back in November. It allocates $10 million per year over five years to CMS for the project. 
    • “The Ensuring Patient Access to Critical Breakthrough Products Act of 2024, if passed, would give any device designated as “breakthrough” from the Food and Drug Administration (FDA) four years of Medicare coverage. Co-sponsor of the bill Rep. Susan DelBene, R-Washington, said during the hearing that it takes CMS an average of more than five years to make a national coverage determination for FDA breakthrough devices.” 
  • BioPharma Dive lets us know,
    • “The Food and Drug Administration on Tuesday approved a new Alzheimer’s disease drug from Eli Lilly, several weeks after a panel of independent experts unanimously recommended its clearance.
    • “The drug, which Lilly will sell as Kisunla, is designed to slow Alzheimer’s progression by clearing from the brain a toxic, sticky protein called amyloid that scientists have long seen as a root cause of the disease. It’s the third of its kind to reach market, following similar medicines from Eisai and Biogen.
    • “In approving Kisunla, the FDA OK’d use in a roughly similar patient population as Eisai and Biogen’s Leqembi. Labeling for the drug, also known as donanemab, recommends doctors start treatment in patients who have mild cognitive impairment or dementia due to Alzheimer’s, and who have confirmed amyloid pathology.
  • Fierce Healthcare points out,
    • “Accountable care organizations concerned they would be held responsible for bad actors exploiting the Medicare system can breathe a sigh of relief.
    • “The Centers for Medicare & Medicaid Services (CMS) stepped in Friday [June 29] and proposed a rule that ensures they are safe from unfair financial ramifications.
    • “The rule (PDF), if finalized, would exclude payment amounts for certain intermittent urinary catheters submitted from suppliers used for assessing performance year 2023 financial performance of Medicare Shared Savings Program (MSSP) ACOs. Benchmarks will be set for 2024, 2025 and 2026, the agency said in a news release.”
  • The Washington Post offers background on the underlying fraud.
    • “Medicare officials this week separately confirmed that 11 companies were collectively responsible for $3.16 billion in questionable bills for urinary catheters between January 2023 and March 2024, saying the agency had successfully blocked payments to the companies.
    • “The ACOs said they identified 12 companies engaged in the alleged fraud, which they say stretches back into late 2022 or even earlier.
    • “Gaus, a 50-year veteran of the health-care industry, said he was not aware of Medicare ever before overhauling its payment rules in response to alleged fraud — a conclusion shared by several current Medicare officials who spoke with The Post. He warned that similar schemes are likely on the horizon.
    • “These fraudsters can get patient IDs, provider IDs, and maybe use AI to glean through these massive files of patient data that they collect from everywhere,” Gaus said.”
    • FEHBlog note: The Post broke the fraud story back in February 2024.}
  • KFF discusses the health policy implications of the June 29 Supreme Court decision dispensing with the Chevron doctrine. The article concludes,
    • “Short of unlikely Congressional action to restore Chevron deference, the Supreme Court in a single decision has shifted many policy decisions from agency technical experts to federal judges, with implications for health policy that will reverberate for years to come.”
    • FEHBlog opinion — The Supreme Court decision does not object to agency fact finding, which is an appropriate field for agency technical experts. The Supreme Court held that judges, not agency technical experts, should interpret the law (see Article III of the U.S. Constitution).
  • Following any decision, the Supreme Court can issue what’s colloquially known as a GVR order in related cases. GVR stands for granting certiorari, vacating the lower court judgment, and remanding for consideration in light of a particular recent decision. Yesterday, the Supreme Court posted an orders list which includes ten Chevron doctrine related GVR decisions in cases from the U.S. Court of Appeals for the D.C. Circuit (several to that Court), plus the Fourth, Fifth, Eighth, Ninth, and Eleventh Circuits. Consequently, we will have a lot of appellate decisions interpreting Loper Bright Enterprises v. Raimondo, 603 U. S. _ (2024) before long.
  • Per an HHS press release,
    • “Following the Supreme Court’s decision in Moyle v. United States, U.S. Department of Health and Human Services Secretary Xavier Becerra and the Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure sent a letter to hospital and provider associations across the country today reminding them that it is a hospital’s legal duty to offer necessary stabilizing medical treatment (or transfer, if appropriate) to all patients in Medicare-participating hospitals who are found to have an emergency medical condition. CMS also announced that the investigation of EMTALA complaints would proceed in Idaho while litigation continues in the lower courts. * * *
    • “In 2022, CMS issued guidance – PDF to reaffirm that EMTALA requires providers offer necessary stabilizing care for patients suffering emergency medical conditions, which might include abortion care in certain situations. Today’s letter reinforces previous letters from Secretary Becerra and Administrator Brooks-LaSure to hospital and provider associations reminding them of their obligations under EMTALA.”
  • The Centers for Medicare Services posted version 7.2 of the Section 111 reporting guidance for group health plan users today.

From the public health and medical research front,

  • Beckers Hospital Review informs us,
    • “Hospitals across the country are finalizing staffing plans and issuing public warnings on fireworks safety ahead of the July Fourth holiday, when an average of around 91,000 patients visit emergency departments. 
    • “We are entirely staffed up for both the Fourth of July as well as the 5th of July,” Aekta Miglani, MD, medical director of the emergency department at Strong Memorial Hospital in Rochester, N.Y., told CBS affiliate WROC. “Every year we work really closely with our trauma division who we’re lucky to collaborate with on a regular basis, but Fourth of July is one of those holidays where we’ll be working [together] my guess is more frequently than others.” 
    • “On average, emergency departments see nearly 45,000 people daily on July 4 and 5, according to a Pew Research Center analysis of injury data from 2000 to 2018. In 2022, fireworks were involved in an estimated 10,200 injuries treated across hospital emergency departments, though physicians believe that number is much greater, since not everyone seeks care.” 
  • The Wall Street Journal compares the two FDA-approved Alzheimer’s Disease drugs – Kisunla Leqembi.
  • STAT News tells us,
    • “As the H5N1 bird flu outbreak in dairy cows enters its fourth month, the Centers for Disease Control and Prevention is taking steps to ramp up the nation’s capacity to test for the virus in people.
    • “In a call with reporters Tuesday, Nirav Shah, the CDC’s principal deputy director, emphasized that the risk to the general public remains low at this time. But given that the virus is showing no signs of slowing its push deeper into the U.S. cattle population — threatening to create lasting risks to dairy workers and giving it more chances to evolve in ways that make it better at spreading to and among humans — the agency is looking to increase the number and types of tests that can effectively detect H5N1 infections in people. * * *
    • “On Tuesday, the federal government also announced plans to support the development of messenger RNA-based pandemic influenza vaccines, including those that target H5 and H7 avian influenza viruses. BARDA, the Biomedical Advanced Research Development Authority, awarded Moderna $176 million to accelerate clinical testing of its pandemic vaccines, which are expected to enter a Phase 3 trial sometime next year. The U.S. government already has vaccine contracts and stockpiles of H5 vaccines made using other platforms by other manufacturers, including CSL Seqirus and Sanofi.”
  • The Washington Post notes,
    • “Only about 18 percent of eligible Americans were up to date with their lung cancer screenings in 2022, with compliance rates varying by state and region, according to a study published in JAMA Internal Medicine. American Cancer Society researchers analyzed data from the 2022 Behavioral Risk Factor Surveillance System, a population-based, nationwide survey of Americans.
    • “Screening eligibility was determined using 2021 U.S. Preventive Services Task Force criteria, which recommend annual lung cancer screening in high-risk individuals — defined as those with a pack-a-day cigarette habit for 20 years or more who are current smokers or have quit within the past 15 years and are between ages 50 and 80. * * *
    • “Screening can prevent deaths from lung cancer because the disease is “usually easier to treat at early stages,” according to the Centers for Disease Control and Prevention.”
  • The Wall Street Journal relates,
    • “Scientists suspect that one culprit behind your new illness might be the infection you got a couple of years ago. 
    • “The link between new health problems and your past health history appears to be particularly prevalent with Covid. A new Nature Medicine study found that health problems stemming from even mild Covid infections can emerge as many as three years afterward. The study found a greater risk three years later of problems in the gut, brain and lungs, including irritable bowel syndrome, mini-strokes and pulmonary scarring.
    • “This is different from what most people think of as “long Covid,” the debilitating chronic condition that can include fatigue, brain fog and racing heartbeat. Instead, the latest study has found an increased risk of new health conditions—things you probably wouldn’t think of as related to a prior illness—developing years later.”
    • FEHBlog note — The article states that a similar phenomenon occurred after the Spanish flu epidemic of 1918.
  • The National Cancer Institute posted new cancer information highlights today.
  • The National Institutes of Health announced,
    • “Scientists at the National Institutes of Health (NIH) have uncovered a brain circuit in primates that rapidly detects faces. The findings help not only explain how primates sense and recognize faces but could also have implications for understanding conditions such as autism, where face detection and recognition are often impaired from early childhood. The newly discovered circuit first engages an evolutionarily ancient part of the brain called the superior colliculus, which can then trigger the eyes and head to turn for a better look. This better view enables different brain areas in the temporal cortex to engage in more complex facial recognition. The study was published in the journal Neuron.
    • “Quick recognition of faces is a key skill in humans and other primates,” said Richard Krauzlis, Ph.D., of NIH’s National Eye Institute (NEI) and senior author of the study. “This newly discovered circuit explains how we’re able to quickly detect and look at faces, even if they first show up in the peripheral visual field where visual acuity is poor. This circuit could be what spotlights faces to help the brain learn to recognize individuals and understand complex facial expressions, helping us acquire important social interaction skills.”
  • The American Medical Association tells us what doctors wish their patients knew about kidney stones.
  • The Institute for Clinical and Economic Review announced,
    • “posting its revised Evidence Report assessing the comparative clinical effectiveness and value of imetelstat (Rytelo, Geron Corporation) for the treatment of anemia in myelodysplastic syndrome (MDS).  
    • “Patients that have anemia related to MDS may have to plan around frequent blood transfusions, which can significantly affect their daily activities,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “Imetelstat is a new treatment option for adults with low-to-intermediate MDS and transfusion-dependent anemia. While available clinical evidence suggests that imetelstat may reduce or eliminate the need for transfusions, its impact on the severe fatigue that often accompanies MDS anemia is less clear. There is no evidence to suggest that imetelstat reduces the progression or trajectory of MDS itself, and there are some key side effects of concern. As a result, we view the evidence as promising but inconclusive, and the current list price is not at all aligned with the modest benefit we do see.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on July 19, 2024. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “A new analysis from KFF digs into insurers’ financial performance across multiple markets and found the highest gross margins in the Medicare Advantage (MA) space.
    • “At the end of 2023, gross margins per enrollee in MA were $1,982 on average compared to $1,048 in the individual market. Medicaid was the lowest at $753 in gross margin per enrollee, and group plans fell in the middle at $910. Gross margins are a notable indicator for financial performance, though they’re not necessarily indicative of profitability as they do not account for administrative costs or tax liabilities.
    • “Gross margins in MA were similar in 2023 to those recorded in the 2022 version of the analysis, according to KFF. In 2022, MA plans averaged $1,977 per enrollee. This is despite concerns from multiple major players in this space about a spike in utilization over the course of 2023.
    • “Across most markets, gross margins have been relatively stable in recent years, though they have declined somewhat from spikes that occurred in 2020 during the initial phase of the COVID-19 pandemic,” the researchers wrote.”
  • Beckers Payer Issues lets us know,
    • “Humana provides the best customer experience to its members, according to Forrester’s “U.S. Health Insurers Customer Experience Index Rankings” for 2024.
    • “The June 17 ranking shared with Becker’s found that customer satisfaction with health insurers is on the decline, with half of the named insurers seeing lower scores compared to last year and none with improved scores. The industry’s average CX Index score dropped 2.7 points, a third straight year of declines. Average scores peaked at 70.2 out of 100 in 2021 and declined to 66.6 in 2024. 
    • [The FEHBlog notes that CareFirst, Kaiser Permanente, and UnitedHealthcare came in second, third, and fourth in the rankings.]
  • and
    • “Several Trinity Health hospitals from coast to coast are now out of network with UnitedHealthcare amid reimbursement disputes between the organizations. * * *
    • “Several of Livonia, Mich.-based Trinity’s ministries and hospitals have been renegotiating contracts with UnitedHealthcare to replace deals that expired at midnight on June 30. Deals have been reached in Florida and Iowa, but negotiations are ongoing for facilities located in Connecticut, Massachusetts, New York, Georgia, Indiana and California.”

Friday Factoids

David Ermer–CDC, FDA, HSA, Medical / Rx research, Mental health care, NIH, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The American Hospital Association News reports,
    • “The U.S. Supreme Court June 28 overturned a 1984 ruling in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which required courts to defer to federal agencies to interpret ambiguous laws. Decided by a 6-3 vote [written by Chief Justice Roberts], the Court held:
    • “Chevron is overruled. Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the Administrative Procedure Act requires. Careful attention to the judgment of the Executive Branch may help inform that inquiry. And when a particular statute delegates authority to an agency consistent with constitutional limits, courts must respect the delegation, while ensuring that the agency acts within it. But courts need not and under the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
  • FEHBlog observation: In short, the Supreme Court’s sensible, prospective decision creates a level playing field for American businesses and other citizens challenging administrative actions.
  • Fierce Healthcare tells us,
    • “Attorney General Merrick Garland announced Thursday [June 27, 2024,] a two-week operation in which 193 people across the country, including 76 licensed healthcare providers, were charged for their alleged participation in healthcare fraud schemes.
    • “The 145 cases highlighted by the Department of Justice (DOJ) involved over $2.75 billion of intended losses and $1.6 billion in actual losses, Garland said. Among allegations highlighted by the DOJ were medically unnecessary amniotic wound grafts, diverted HIV medications, online distribution of Adderall and other telemedicine schemes.
    • “As healthcare fraud schemes continue to evolve, so will the Justice Department’s investigative and prosecutorial strategies,” Garland said during a Thursday press conference. “Our messages to those seeking to exploit patients and defraud government programs is clear: You cannot hide your crimes. We will find you, and we will hold you accountable.”
  • Kauffman Hall reports,
    • “In late April, the Centers for Medicare & Medicaid Services (CMS) established new staffing standards for long-term care (LTC) facilities, mandating a minimum of 3.48 hours of nursing care per patient per day, with 33 minutes of that care from a registered nurse, at least one of whom must be always on site. The rule is slated to go into effect in two years for urban nursing homes and three years for rural nursing homes, with some facilities able to apply for hardship exemptions. 
    • “Although about one in five LTC facilities nationwide currently meet these staffing standards, staffing levels vary greatly by both state and facility ownership profile. In 28 states, fewer than a quarter of LTC facilities meet the new standards, and in eight states fewer than 10% of facilities are already in compliance. 
    • “Facilities in Texas are the least ready, with only 4% meeting the new staffing minimums. In terms of ownership structure, only 11% of for-profit facilities—which constitute nearly three quarters of all LTC facilities nationwide—have staffing levels that meet the new staffing minimums. 
    • “The Government Accountability Office projects this new rule will cost LTC facilities $43B over the first ten years, a significant expense at a time when recruiting and retaining nursing talent is already challenging. 
    • “Citing the risk of mass closures from facilities unable to comply, nursing home trade groups are suing to stop the mandate from going into effect, and there is also a bill advancing in the House that would repeal the staffing ratios. That bill is backed by the American Hospital Association, which fears the mandate “would have serious negative, unintended consequences, not only for nursing home patients and facilities, but the entire health continuum.”
  • HR Dive reminds us,
    • “While there’s still a small chance it could be blocked, the first step of the U.S. Department of Labor’s overtime final rule is set to go into effect Monday — raising the minimum salary threshold for overtime from $35,568 to $43,888.
    • “Almost every workplace should be prepared with needed adjustments, but there are still a few last-minute actions HR should undertake if they haven’t to protect their organizations, Victoria Lipnic, partner at Resolution Economics and former EEOC commissioner, and Jonathan Segal, partner at Duane Morris LLP, said at a Monday panel at the Society for Human Resource Management’s annual conference.”
    • The three items are explained in the article. 

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • COVID-19
      • During April and May 2024, COVID-19 activity was lower than at any time since the start of the pandemic. Recent increases need to be considered from that baseline. This includes increases in COVID-19 test positivity and emergency department visits, suggesting growth in COVID-19 activity across several states, and increases in rates of COVID-19–associated hospitalizations among adults 65+ at some Western sites. While there are indications for the potential start of a summer surge, nationally COVID-19 activity remains low. CDC will continue to monitor to see if these recent increases persist.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
    • “National vaccination coverage for COVID-19, influenza, and RSV vaccines remained low for children and adults for the 2023-24 respiratory illness season. COVID-19 vaccines continue to be recommended and can provide a layer of protection.”
  • The Hill lets us know,
    • “The CDC recommended [on June 27, 2024] that all Americans 6 months and older receive the flu vaccine, noting that it will offer protection against the against H1N1, H3N2, and a B/Victoria lineage virus.
    • “And during the 2023-24 flu season, more than 44,900 people are estimated to have died from flu complications.
    • “The CDC emphasized that it was safe to receive the flu and COVID shots at the same time.”
  • Per MedTech Dive,
    • “Cepheid said Thursday it received de novo authorization for the only molecular test in the U.S. to detect hepatitis C virus RNA directly from fingerstick blood samples. 
    • “The Food and Drug Administration authorization positions healthcare professionals to diagnose hepatitis C at the point of care. The agency said that patients could be diagnosed and treated at the same healthcare visit.
    • “Cepheid’s authorization establishes special controls, clearing other companies to bring similar tests to market in the U.S. via the 510(k) pathway.” 
  • Fierce Pharma points out,
    • “After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer and its dominant Prevnar franchise.
    • “At a meeting this week, the CDC’s Advisory Committee on Immunization Practices (ACIP) gave a unanimous vote, with one abstention, in favor of the vaccine in millions of adults. Specifically, the vaccine experts recommended the shot for adults 65 and older who have not yet received a pneumococcal conjugate vaccine, plus for those 19 to 64 with certain underlying medical conditions or other risk factors.
    • “Adults 19 years old and up who have started their pneumococcal vaccine series with Pfizer’s Prevnar 13 but have not received all of the recommended Merck’s Pneumovax 23 doses are also included in ACIP’s endorsement.
    • “The ACIP vote recognizes the clinical profile of Capvaxive for adults in the U.S., and we look forward to the CDC’s final, published recommendations,” Merck’s chief medical officer Eliav Barr, M.D., said in a press release.
    • “Capvaxive protects against 21 serotypes of the bacterial infection that comprise 84% of the pneumococcal disease contracted by adults 50 and older, according to epidemiologic data from the CDC. Pfizer’s leading pneumococcal disease vaccine, Prevnar 20, protects against 20 serotypes that comprise 52% of the disease in that population.
  • The Institute for Clinical and Economic Review announced yesterday,
    • “ICER released a Final Evidence Report assessing the comparative clinical effectiveness and value of MDMA-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD).
    • “ICER’s Chief Medical Officer David Rind, MD stated:
      • “PTSD can be a severe condition affecting nearly all aspects of an individual’s life, and many current therapeutic options are insufficient for many people with PTSD. Despite two randomized trials of MDMA-AP, functional unblinding in the trials and additional concerns around trial design and conduct led to ICER concluding that the publicly available evidence is insufficient to assess the balance of benefits and harms. It was encouraging to learn that FDA is investigating such issues, including those brought to light at our Public Meeting.”
    • “For every report, ICER follows a process that includes numerous opportunities for stakeholders to engage and be involved throughout its development. Our reports always begin with an initial scoping phase, followed by development of a Draft Evidence Report. We consider all of the public comments on the Draft Evidence Report as we put together the revised Evidence Report, which is discussed at a public meeting with patients, clinical experts, manufacturers, payers, and policy experts. After that public discussion, we release the Final Evidence Report.”
  • Per Health Day,
    • “An immunotherapy/chemotherapy combo drug can help early-stage breast cancer patients remain cancer-free following treatment, a new trial shows.
    • “The combo drug, Kadcyla, is already approved to treat patients with advanced HER2-positive breast cancer, researchers said.
    • “The new results show that stage 1 breast cancer patients who received Kadcyla stayed free of invasive cancer five years after treatment.
    • “One year of [Kadcyla] after surgery for patients with a stage 1 HER2-positive cancer leads to outstanding long-term outcomes, making it a reasonable treatment approach for select patients,” said senior study author Dr. Sara Tolaney, chief of breast oncology at Dana-Farber Cancer Institute in Boston.”
  • and
    • “Just 25% of people battling opioid use disorder are getting medications aimed at helping them quit and potentially avoid an overdose, new data shows.
    • “Boosting access to proper treatment might save countless lives.
    • “In 2022, 81,806 opioid-involved overdose deaths were reported in the United States, more than in any previous year,” noted a team led by Deborah Dowell, chief medical officer at the U.S. Centers for Disease Control and Prevention’s Division of Overdose Prevention.
    • “Dowell and her colleagues looked at data collected for 2022 as part of the National Survey on Drug Use and Health. The survey involved almost 57,000 adults.”
  • The National Institutes of Health adds,
    • “Results from a national survey indicate that many Americans, 61%, are unaware that primary care physicians can prescribe medications for opioid use disorder, and 13% incorrectly believed that they could not. The survey, funded by the National Institutes of Health (NIH), also found that 82% of the people who reported ever misusing prescription or illicit opioids expressed comfort in going to their primary care physicians for medications for opioid use disorder. Among those who had not misused opioids, a majority, 74%, reported they would be comfortable referring their loved ones to primary care for these medications.
    • “Notably, Black American respondents were most likely to incorrectly believe they could not receive medications for opioid use disorder via primary care, pointing to an important disparity in information that may further impede access to treatment. The findings suggest there is an important opportunity to increase awareness of these treatments and how to access them – using efforts that employ culturally specific strategies to reach different groups. Decades of research have shown the overwhelming benefit of existing medications for opioid use disorder, such as buprenorphine and methadone.
    • “Primary care is often people’s first point of contact in the health care system and can serve as a crucial setting to talk about addiction and receive lifesaving medications,” said Nora D. Volkow, M.D., Director of NIH’s National Institute on Drug Abuse (NIDA). “We need to provide education and support so that patients feel empowered to seek help from their primary care physician, and their doctors feel prepared to help them.”
  • Behavioral Health Business explains why “Feeding Disorder Treatment Programs Are Urgently Needed for Children with Autism.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Optum will not bid on Steward Health Care’s physician group, Stewardship Health, during the bankrupt health system’s upcoming auction, a Massachusetts state official has confirmed.
    • “The news is a major setback for Steward, which has repeatedly identified selling Stewardship as critical for its financial stabilization. 
    • “Steward took out $150 million in loans to fund the transaction in February. Its attorneys have claimed during federal bankruptcy proceedings that the sale proceeds would be enough to cover debts to certain lenders and, as recently as June 13, the Dallas-based system tied $75 million of new debtor-in-possession financing — which funds operations during restructuring — to the successful completion of a Stewardship sale.
    • “While Steward hammered the importance of selling Stewardship, it only had one public buyer at the table: UnitedHealth-owned Optum. 
  • and
    • “Amwell is implementing a reverse stock split to avoid being kicked off the New York Stock Exchange, the telehealth vendor said Friday. 
    • “The company has struggled to reach profitability, and its stock price has declined precipitously since entering the public markets in 2020. In April, the telehealth company received a warning notice from the NYSE that its stock was trading below minimum standards, closing at less than $1 per share for 30 consecutive days. 
    • “The company’s board of directors approved a 1-for-20 reverse stock split, a maneuver that consolidates the number of existing shares of stock to boost its share price. The split will be effective at market close on July 10.”
  • MedCity News shares expert observations on recent acquisitions by Kaiser Permanente’s Risant Health subsidiary.
    • “Is Risant Health the rising star of scalable, profitable value-based care models for health systems?
    • “It’s a little early to break out the champagne and toast to the company’s success, but it might soon be time to start thinking about ordering some flute glasses should a celebration be in order.”
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Rhode Island is eliminating nearly 65% of prior authorization requirements for primary care providers by early 2025. 
    • “BCBSRI reviewed data to identify some of the most common orders that create additional work for PCPs. Radiology and cardiology services lead the list of requirements being cut, and the changes will apply across commercial and Medicare plans, according to a June 27 news release. * * *
    • “BCBSRI removed all prior authorization for outpatient behavioral services in 2018. Other payers such as UnitedHealthcare, Cigna, BCBS Michigan, Point32Health and Aetna have all reduced prior authorization requirements recently.”
  • The Employee Benefits Research Institute presents an EBRI Issue Brief titled “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Medication Adherence.”
    • “IRS Notice 2019-45 allows health savings account (HSA)-eligible health plans the flexibility to cover 14 drug classes and other health services used to prevent the exacerbation of chronic conditions prior to meeting the plan deductible. In this Issue Brief, we used claims data to quantify the effect of expanding pre-deductible coverage on medication adherence among enrollees with certain chronic conditions. We found some evidence that expanding pre-deductible coverage in HSA-eligible health plans increased medication adherence in 2022, but not earlier.”