Friday Factoids

Medicare

Friday Factoids

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplas

From Washington, DC,

  • The Washington Post reports
    • Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) this week wrote to eight pharmaceutical company CEOs, urging them to remove 130 patents from a key federal registry, according to letters shared with The Washington Post. The Democrats are targeting Novo Nordisk, including some of its patents related to expensive drug Ozempic; GlaxoSmithKline; and other companies that produce asthma and diabetes medications.
    • The 130 patents are among more than 300 patents that the Federal Trade Commission in April identified as “junk patent listings” that should be removed from the registry and are blocking competitors from producing cheaper alternatives. Monday is the deadline for the companies to remove the patents or reaffirm that they believe the patents are legal, according to a person who spoke on the condition of anonymity to detail the private enforcement process.
  • STAT News tells us,
    • “The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50.”The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50.
    • “Arexvy, which was the first RSV vaccine approved, now becomes the first to be available to adults under the age of 60 who are not pregnant. Prior to this FDA decision, Arexvy was licensed for use in people 60 and older.”
  • Tammy Flanagan writing in Govexec discusses the state of federal civil service retirement: CSRS and FERS.
  • Govexec adds,
    • “The government’s backlog of pending retirement claims from federal workers hit an eight-year low last month. “The government’s backlog of pending retirement claims from federal workers hit an eight-year low last month.
    • “The Office of Personnel Management’s retirement process and subsequent backlog has long dogged the federal government’s HR agency, frustrating agencies and departing federal employees alike, in large part due to paper-based legacy personnel systems.
    • “But last year, OPM instituted a number of measures to try to make immediate improvements to the process, including dedicating more resources and manpower during the early-year busy season for retirement claims and setting up a new dashboard for claimants to better understand the process and avoid common pitfalls.
    • “In May, OPM received 6,751 new retirement applications, a slight decrease from the 6,901 it received the previous month. But after a modest decrease in the number of claims actually processed in April, the agency increased its pace again last month, processing 8,793 claims.
    • “By the end of the month, the backlog had fallen to 14,035, compared to 16,077 pending claims at the end of April. That marks the smallest retirement backlog OPM has experienced since May 2016, when it also finished the month with a backlog of 14,035 applications.”

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • Summary
      • Seasonal influenza, COVID-19, and RSV activity is low nationally.
    • COVID-19
      • Most key indicators are showing low levels of activity nationally. However, COVID-19 test positivity has increased to 4.5%. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 30 states and territories, declining or likely declining in 1 state or territory, and are stable or uncertain in 18 states and territories, based on Rt estimates of epidemic growth. An increasing proportion of the variants that cause COVID-19 are projected to be KP.3 and LB.1 (CDC COVID Data Tracker: Variant Proportions).
    • Influenza
    • RSV
      • Nationally, RSV test positivity remains low. Hospitalization rates are low in all age groups.
    • Vaccination
  • The Washington Post offers background on bird flu — How it spreads, milk and egg safety and more.
  • The New York Times reports,
    • “The American Cancer Society has begun an ambitious, far-reaching study focusing on a population that has long been overlooked, despite high rates of cancer and cancer-related deaths: Black women.”The American Cancer Society has begun an ambitious, far-reaching study focusing on a population that has long been overlooked, despite high rates of cancer and cancer-related deaths: Black women.
    • “The initiative, called VOICES of Black Women, is believed to be the first long-term population study of its size to zero in specifically on the factors driving cancer prevalence and deaths among Black women.
    • “Researchers plan to enroll 100,000 Black women without cancer, ages 25 to 55, in Washington, D.C., and 20 states where most Black American women reside. The subjects will be surveyed twice a year about their behaviors, environmental exposures and life experiences, and followed for 30 years; any cancers they may develop will be tracked.
    • “Similar studies by the American Cancer Society in the past yielded critical lessons about what causes cancer — for example, identifying cigarette smoking as a cause of lung cancer and linking red- and processed-meat consumption to increased risk of colon cancer.”
  • STAT News points out,
    • “The moment when a person stops taking their antidepressant is fraught. Not only can patients see their psychiatric symptoms return, but they can experience a wide variety of new symptoms in the days and weeks immediately following the medication change.
    • “Symptoms like nausea and headache can be manageable, and typically begin and end within days of ending the medication. But more disruptive effects like insomnia, irritability, and sensory disturbance, or even severe ones like suicidal ideation or lethargy, can lead patients to reconsider their decision to stop treatment, even when they resolve relatively rapidly.
    • “A new systematic review of studies on antidepressant discontinuation published on Tuesday in The Lancet Psychiatry provides insight into the frequency and gravity of those symptoms. The review, which included 79 studies capturing 21,000 patients, found that about 15% experienced withdrawal symptoms after weaning from antidepressants. In 2 to 3% of the cases, the symptoms were severe.
    • “The analysis “is an important and long overdue contribution to the research literature,” said Awais Aftab, a professor of psychiatry at Case Western Reserve University School of Medicine, who did not participate in the study. It confirms that withdrawal symptoms do happen with clinically relevant frequency, and should be managed with care. But it demonstrated a lower incidence than recent estimates based on online surveys, which generated public alarm when they suggested symptoms may occur in half or more of the patients.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Humana and CVS, two of the largest Medicare Advantage insurers in the country, are poised to seriously downgrade their plan benefits and geographic presence next year as they chase profits in the privately run Medicare program.”Humana and CVS, two of the largest Medicare Advantage insurers in the country, are poised to seriously downgrade their plan benefits and geographic presence next year as they chase profits in the privately run Medicare program.
    • “As a result, hundreds of thousands of Medicare Advantage seniors — and the billions in revenue they represent — could come up for grabs, representing a significant opportunity for insurers looking to take on more members despite ongoing challenges in MA.
    • “The size of the turnover depends on a number of factors. Deciding which benefits to cut versus keep is a tough calculus, and there are guardrails from the federal government limiting cutbacks, experts say.
    • “Those decisions have been made — bids were due to the CMS on Monday. However, it will be months before the industry knows how much turbulence Humana and CVS might cause in their drive to bolster profits next year, and which insurers might benefit.
    • “Of the national payers, market leader UnitedHealth may be best situated to pick up switching seniors, solidifying its dominance in MA, experts say.
    • “I think there will be a huge shakeup,” Alexis Levy, the managing director of health consultancy Chartis’ payer advisory practice, said.”
  • Beckers Payer Issues notes,
    • “Artificial intelligence has the potential to lower internal and member costs, for insurers while also increasing profits, but the industry has largely not embraced these opportunities, according to a June 5 analysis from McKinsey.”Artificial intelligence has the potential to lower internal and member costs, for insurers while also increasing profits, but the industry has largely not embraced these opportunities, according to a June 5 analysis from McKinsey.
    • “Incremental approaches will continue to yield only minor savings, as we have seen to date across most of the industry,” the analysts wrote. “To capture full value, payers must reimagine the end-to-end processes of each domain.”
    • “Three key takeaways: 
      • 1. “If payers fully implemented already available generative AI and automation technologies, on average they could save 13-25% on administrative costs, 5-11% on medical costs and increase revenues by 3-12%.
      • 2. “Marketing and sales, utilization management, and IT are the divisions with the largest potential opportunities when using AI.
      • 3. “Payers that want to better use AI technology should have these six key things: a strategic plan, the right talent, a conducive operating model, technological capabilities, consumable data and the ability to ensure adoption and scale.
      • “In general, most payers are ill-equipped to pursue this opportunity,” the analysts wrote. “To do so, they have to close the gap that exists between their current capabilities and those needed to fully address the six areas outlined above.”
  • STAT News relates,
    • “Amid rising concern over prescription drug shortages, a new report finds that the number of shortages has increased over the past decade, most are lasting longer than ever before, and the problem is affecting medicines used to treat a wide range of maladies.
    • “Specifically, the average shortage lasted for more than three years in 2023 compared to about two years in 2020, and 27 of the 125 drugs in short supply were not available for more than five years. And 53% of new shortages occurred among generic sterile injectable medicines, according to the report from U.S. Pharmacopeia, an independent organization that develops standards for medicines.
    • “Meanwhile, most medicines for which shortages existed cost less than $5; nearly one-third of injectables cost less than $2; and two-thirds of solid oral medicines cost $3 or less. These low prices also translated into more product discontinuations, which rose by 40% from 2022 to 2023, and from 100 drugs to 140 during that time. This was also the highest rate of product discontinuations since 2019.
    • “A key culprit, according to U.S. Pharmacopeia, often are thin profit margins. “Economic pressures, especially the very low prices that generics manufacturers recover for many medicines, along with contracts that are frequently broken, have left our generic medicine supply chain fragile,” said Anthony Lakavage, senior vice president for global external affairs, in a statement.”

Friday Factoids

David Ermer–AHRQ, CDC, COVID-19, FDA, Medicare, Mental health care, NCQA, No Surprises Act, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Bloomberg News reports,
    • “Federal agencies are aiming to issue final regulations this year that aim to make the arbitration process more efficient for No Surprises Act health care payment disputes, an IRS official said.
    • “The regulations are a priority for the Treasury, Labor, and Health and Human Services departments, said IRS Office of Chief Counsel Senior Technician Reviewer Kevin Knopf during a Thursday panel at the Federal Bar Association’s Insurance Tax Seminar.
    • “The proposed rules aim to reduce certain administrative fees tied to participating in an independent dispute resolution system that arbitrates clashes between medical providers and health insurers over payments. They also aim to clarify requirements to prove that a dispute is eligible for the dispute resolution process.” 
  • The Department of Health and Human Services (“HHS”) announced,
    • “Today, on National Heat Awareness Day, the U.S. Department of Health and Human Services (HHS) is launching a new tool to help communities prepare for extreme heat and prevent heat-related illness, especially among those most at risk. The Heat and Health Index (HHI) is the first nationwide tool to provide heat-health outcome information at the ZIP code level. The HHI will help state and local officials identify communities, at the zip code level, most likely to experience negative health outcomes from heat, ensure that outreach and medical aid reach the people who need it most, and help decision-makers prioritize community resilience investments.”
  • The National Committee for Quality Assurance released a fact sheet about Mental Health Awareness Month, which ended today.
  • HHS’s Agency for Health Research and Quality tells us,
    • “As we round out Older Americans Month, it is crucial that we continue to recognize the significant contributions of older adults and the urgent need to transform and improve their healthcare. Our current system is ill-equipped to meet the complex needs of older adults, who often contend with multiple chronic conditions. This inadequacy leads to fragmented and sub-optimal care, resulting in poor health outcomes, avoidable adverse events, hospitalizations, institutionalization, and increased costs. 
    • “To meet these challenges, AHRQ remains committed to using its research capabilities to build the evidence base and identify solutions ready for action. To do so, the agency has released a Special Emphasis Notice to announce its strong interest in funding health services research to improve care quality for older adults.  Research proposals for enhancing service access, delivery, organization, and equitable distribution are welcome. In particular, AHRQ seeks research to address critical questions related to the development, implementation, evaluation, and scalability of person-centered models of care to optimize older adults’ physical and mental health, functional status, and overall well-being.” 
  • BioPharma Dive informs us,
    • The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer.
    • The vaccine, dubbed mResvia, is for the prevention of disease caused by respiratory syncytial virus, or RSV, in adults 60 years of age and older. Experts from the Centers for Disease Control and Prevention are expected to meet next month to provide recommendations on the shot’s use. Moderna had said it expects the vaccine to be available in time for the fall immunization season in the U.S.
  • The Centers for Disease Control (CDC) adds,
    • “The RSV vaccine is not currently an annual vaccine, meaning people do not need to get a dose every RSV season. Currently, CDC recommends only a single dose of RSV vaccine for adults ages 60 and older, using shared clinical decision-making. Additional surveillance and evaluation activities are ongoing to determine whether older adults might benefit from receiving additional RSV vaccines in the future. So far, RSV vaccines appear to provide some protection for at least two RSV seasons.”

From the public health and medical research front,

  • HHS posted a “Fact Sheet: In Response to H5N1, HHS and USDA Focus on Protecting Farmworkers.” For more information on the ongoing response, please visit FDA, CDC, and USDA’s ongoing H5N1 update pages.
  • STAT News reports,
    • “There are a lot of reasons why updated data on Pfizer’s Lorbrena, a treatment for non-small cell lung cancer, might not seem to be a big deal. The results are an update on the clinical trial that resulted in the Food and Drug Administration granting Lorbrena full approval in 2021, so in a sense they are not even that new. For Pfizer investors, Lorbrena isn’t that big a deal, either. The medicine, for patients whose lung tumors have particular genetic mutations, generated only $575 million last year — an amount that is up 57% from the year prior, but that still constitutes only 1% of the drug giant’s annual sales.
    • “But there is one number that makes the Lorbrena data quite eye-catching: In the updated data, the daily pill decreased the risk that cancer would progress or that a patient would die by 81% over five years.
    • “That’s a stunning number, especially when one considers that Lorbrena was not being compared to an inert placebo but to Xalkori, another Pfizer targeted cancer drug.
    • “Put a different way, 60% of the patients who received Lorbrena were alive and had not seen their tumors progress in the five years of the study, compared to 8% who received Xalkori.
    • “The data are being presented at the annual meeting of the American Society of Clinical Oncology and published in the Journal of Clinical Oncology.“
  • BioPharma Dive informs us,
    • “People with chronic myeloid leukemia, a simmering cancer of the bone marrow, are often treated with one of several targeted drugs that, over the past two decades, have helped to substantially prolong survival from the disease.
    • “Study results revealed Friday suggest that Scemblix, the newest of those therapies, can be both safer and more effective, potentially supporting wider use of it as an initial treatment. The results are from a late-stage clinical trial run by Scemblix’s maker, Novartis, and will be presented at the American Society of Clinical Oncology’s annual meeting.
    • “In the trial, dubbed ASC4FIRST, Scemblix led to treatment responses in significantly more participants than did other targeted drugs, which included the mainstay therapy Gleevec as well as more recently introduced medicines. Additionally, more people given Novartis’ drug experienced what’s called a “deep molecular response,” which over time can be considered a remission and allow treatment to be stopped.
    • “Study researchers also reported “markedly favorable safety and tolerability” for Scemblix, compared to Gleevec and the other so-called kinase inhibitors it was tested against.”
  • Medscape notes,
    • A personalized diet, created by integrating microbiome analysis with artificial intelligence (AI) algorithms, is a promising approach to the management of irritable bowel syndrome(IBS) symptoms, leading to enhanced symptom relief and greater gut microbiome diversity than a standard low–fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet, new research suggests.
  • and
    • “About 9 out of 10 people will have a genetic difference in their DNA that can impact how they respond to common medications,” said Emily J. Cicali, PharmD, a clinical associate at the University of Florida College of Pharmacy, Gainesville, Florida.
    • “Cicali is the clinical director of UF Health’s MyRx, a virtual program that gives Florida and New Jersey residents access to pharmacogenetic (PGx) tests plus expert interpretation by the health system’s pharmacists. Genetic factors are thought to contribute to about 25% or more of inappropriate drug responses or adverse events, said Kristin Wiisanen, PharmD, dean of the College of Pharmacy at Rosalind Franklin University of Medicine and Science in North Chicago, Illinois.
    • “Pharmacogenetics helps consumers avoid drugs that may not work well for them or could cause serious adverse events. It’s personalized medicine,” Cicali said.
    • “Through a cheek swab or blood sample, the MyRx program — and a growing number of health system programs, doctors’ offices, and home tests available across the United States — gives consumers a window on inherited gene variants that can affect how their body activates, metabolizes, and clears away medications from a long list of widely used drugs.”
  • The Wall Street Journal recounts the experiences of readers months after stopping GLP-1 drug treatment.

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute relates.
    • According to findings of the Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey, most plan enrollees are satisfied with their health plan, but high-deductible health plan (HDHP) enrollees are less likely to be extremely or very satisfied than traditional plan enrollees.
    • HDHP and traditional plan enrollees are both satisfied with the quality of care received and choice of doctors.
    • Differences in overall satisfaction may be driven by cost sharing. HDHP enrollees are less likely than traditional plan enrollees to be extremely/very satisfied with out-of-pocket expenses for prescription drugs and other health care services.
  • Beckers Hospital Review reports,
    • “The Justice Department has rejected bankrupt Dallas-based Steward Health Care’s suggested auction timeline for its physician group Stewardship Health to be sold to UnitedHealth Group’s subsidiary Optum. 
    • “In a May 28 bankruptcy court filing, obtained by Becker’s, Brian Boynton, principal deputy attorney general for the justice department, detailed how the debtor-in-possession financial deal between Steward and its landlord Medical Properties Trust interferes with the health system’s “obligation to comply with the United States’ antitrust review” of the Stewardship Health, Optum deal and should not be approved.”
  • and calls attention to an American Hospital Association report identifying the inpatient and outpatient services that are biggest money losers for hospitals.
  • Healthcare Dive points out,
    • “Most of the nation’s leading nonprofit healthcare providers reported progress toward financial recovery during earnings for the quarter ended March 31.
    • “However, improvements varied widely by health system, and the industry at large has a long way to go before it is back to profitability levels enjoyed pre-pandemic — if it fully rebounds at all, analysts told Healthcare Dive.
    • “Nonprofits struggled with cost challenges, confirming reports from analysts at credit rating agencies Moody’s Ratings and Fitch Ratings that predicted expenses, particularly labor costs, would continue to vex providers in 2024.
    • “Analysts also expected this year to bring a bifurcated financial recovery for the sector, where health systems that could successfully contain costs would recover more quickly.
    • “With early financial data now in for 2024, that expectation appears to be playing out.”

Midweek Update

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

From Washington DC

Photo by Thought Catalog on Unsplash
  • Fierce Healthcare tells us,
    • “U.S. Senators Sheldon Whitehouse and Bill Cassidy want to reform how primary care providers get paid through Medicare, and they also want to hear from the healthcare industry about the best way to do it.
    • “Whitehouse, a Democrat from Rhode Island, and Cassidy, a physician and Republican from Louisiana, introduced a bipartisan bill, the Pay PCPs Act, S. 4338, on Wednesday to better support and improve pay for high-quality primary care providers. 
    • “The legislation serves as a marker for future primary care legislation and is intended to solicit feedback on a number of important policy questions, the lawmakers said. * * *
    • “Whitehouse and Cassidy also issued a request for information for feedback on policy questions. Feedback can be submitted to physician_payment@cassidy.senate.govuntil July 15, 2024.”
  • Govexec informs us about a mark-up of federal employee telework bills at a Senate Homeland Security and Governmental Affairs committee meeting today.
  • Barrons reports,
    • “Social Security recipients could receive a 3.2% raise next year, according to an estimate based on Wednesday’s inflation result. * * *
    • “The Social Security Administration will announce the actual COLA for 2025 in October, once inflation data from the third quarter are complete. The raise will be equal to the percentage gain in the average level of CPI-W for the third quarter of 2024 from the average for the same period in 2023.
    • “In their annual report, the Medicare Trustees estimated that the standard monthly Part B premium could rise to $185 next year, a 5.9% increase from this year’s $174.70. Part B premiums, which are automatically deducted from Social Security checks, are one of the fast-growing costs in retirement, [independent consultant Mary] Johnson says.
  • Plan Sponsor lets us know,
    • “The ERISA Advisory Council voted during a meeting Wednesday to focus its attention on issues related to welfare plan claims and appeals and qualified default investment alternatives. The council will study these issues and make recommendations to the Employee Benefit Security Administration later this year as per its mandate from the Department of Labor. * * *
    • “Members also considered a review of pension death audit service providers in light of the Central States and Special Financial Assistance controversy in which the Central States pension fund received $127 million in SFA funds for 3,479 dead participants. This error occurred because the plan did not have access to the Social Security death master file and the money was repaid. Since death audit providers also lack access to the DMF, there was concern among some members about how an auditor can certify a death audit at all.”
    • In the FEHBlog’s opinion, it is dumbfounding that pension and health benefit plans are not allowed access to the DMF.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “The U.S. saw a slight decline in the number of new overdose deaths last year, marking a rare improvement in a still-raging national fentanyl crisis, preliminary federal data show. 
    • “There were about 107,500 overdose deaths in 2023, down 3% from the year before and the first decline in five years, according to estimates from the Centers for Disease Control and Prevention. One factor was fewer deaths pegged to opioids including the nation’s deadliest drug, the potent synthetic fentanyl, the CDC’s preliminary numbers show. 
    • “It’s the direction we want to be going,” said Mary Sylla, director of overdose prevention policy and strategy at the National Harm Reduction Coalition, which advocates for measures such as easy-to-access medicine to reverse overdoses.
    • “I just hope we can continue the trend, and I hope we double-down on the evidence-based interventions that save peoples’ lives,” Sylla said.”
    • FEHBlog note — Amen to that.
  • The Centers for Disease Control announced,
    • “Approximately 4,000 unintentional drowning deaths occur annually in the United States, and demographic disparities exist.
    • “Compared with unintentional drowning death rates in 2019 (pre–COVID-19 pandemic), rates were significantly higher during 2020, 2021, and 2022, with highest rates among children aged 1–4 years, non-Hispanic American Indian and Alaska Native persons, and non-Hispanic Black or African American persons. National survey data revealed that 55% of U.S. adults have never taken a swimming lesson, and swimming lesson participation differed by demographic characteristics.
    • “The U.S. National Water Safety Action Plan provides recommendations for drowning prevention actions, including increasing access to basic swimming and water safety skills training for all persons, which could reduce disparities in unintentional drowning deaths.”
    • FEHBlog observation — Focus on training children aged 1-4 years.
  • MedPage Today notes,
    • “Patients hospitalized with COVID-19 were more likely to die than those hospitalized with influenza during the fall and winter of 2023-2024, according to an analysis of Veterans Affairs data.
    • “Among over 11,000 patients hospitalized for either illness during this past fall and winter, 5.7% of patients with COVID-19 died within 30 days of admission versus 4.24% of patients with influenza, reported Ziyad Al-Aly, MD, of the VA St. Louis Health Care System, and colleagues.
    • “After adjusting for variables, the risk of death in people hospitalized for COVID-19 was 35% higher (adjusted HR 1.35, 95% CI 1.10-1.66), the authors detailed in a research letter in JAMA.”
  • Cardiovascular Business adds,
    • “Heart failure (HF) patients who received a COVID-19 vaccine are significantly less likely to be hospitalized for HF symptoms or die for any reason, according to new data presented at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC). 
    • “The analysis included data from more than 651,000 adult Korean residents with HF. The average patient age was 69.5 years old, and 50% were men. Approximately 83% of patients were fully vaccinated against COVID-19, meaning they received two or more doses of an approved vaccine. 
    • “The study’s authors compared 73,559 vaccinated patients with 73,559 unvaccinated patients, matching them 1:1 according to age, sex, comorbidities and other relevant patient attributes. The median follow-up period was six months. 
    • “Overall, COVID-19 vaccination was associated with an 82% lower risk of all-cause mortality, 47% lower risk of hospitalization for HF and 13% lower risk of testing positive for COVID-19. Vaccinated patients also had lower rates of stroke, heart attack, myocarditis/pericarditis and venous thromboembolism during that six-month period.”  
  • Beckers Hospital Review points out,
    • “Ozempic, Mounjaro and other GLP-1s do not increase the risk of surgical complications, according to research published May 14 in Diabetes, Obesity and Metabolism. 
    • “Nearly a year after the American Society of Anesthesiologists recommended patients skip a dose of their GLP-1s — which are medications approved for Type 2 diabetes and weight loss — because of regurgitation and aspiration risks, a review of 130 million patient records found no increased risk. 
    • “GLP-1s can delay gastric emptying, which can minimize the effect of normal fasting rules before elective surgeries. Soon after the ASA published the guidance, surgery departments across the U.S. updated their preoperative care processes to align with the guideline.” 
  • The Washington Post reports,
    • “The Food and Drug Administration this week moved to expand screening for potentially lethal cervical cancer by allowing women to collect test samples themselves, a move that reproductive health advocates view as crucial to stamping out the preventable disease.
    • “For the first time, women will be able to gather samples for testing in private rooms inside offices of primary-care doctors, at urgent-care clinics and even pharmacies — an advance that could presage home testing.
    • “Advocates hope the method will make it easier for women of color and those living in rural and underserved communities to screen for human papillomavirus — HPV — which can lead to a cancer that afflicts 11,000 each year. It comes as the National Cancer Institute has ramped up study of self-collection, partnering with 25 medical schools and cancer centers across the country to gauge use of collecting vaginal samples at home and at health-care facilities. * * *
    • “The collection method was greenlit for the previously approved HPV test Onclarity, manufactured by BD (Becton, Dickinson and Company). The test is expected to be available in summer and will be part of a study of self-collection, the company said in a news release Wednesday.
    • “Roche also received sign off for the self-collection method for its cobas HPV Test, and has been collaborating with the NCI’s study, the company said in a news release. * * *
    • “This literally just opens up another option for a different demographic of people that might not feel comfortable, that might not have access [and] may not have time” to get tested otherwise, said Irene O. Aninye, chief science officer for the Society for Women’s Health Research, a group focused on advancing women’s health and promoting research.”
  • STAT News relates,
    • “Eisai and Biogen said today that they’ve filed an application with the FDA to sell their Alzheimer’s drug Leqembi through an autoinjector for maintenance dosing. That means patients would first go through an initiation phase with the current regimen of IV infusions, but then transition into weekly injections for maintenance.
    • “If approved, this would be a significantly more convenient option for patients, since infusions require patients once every two weeks to travel to a medical facility and receive the infusion for an hour.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Chicago-based CommonSpirit is pushing for change in the dynamics of payer-provider relationships and is “taking a firm stance on contract renewals so payers absorb a share of inflation,” management said in financial documents published May 15. 
    • “The 142-hospital system said one of the most critical levers for health systems to maintain financial stability is to receive the revenue and cash flow they are entitled to for services provided. 
    • “The news comes shortly after CommonSpirit split with Anthem Blue Cross Blue Shield of Colorado. The breakup, which affects commercial and Medicare Advantage members, means 11 of CommonSpirit’s hospitals and more than 40,000 of its patients in the state are now out of network with the insurer. 
    • “It was never our intent to leave the Anthem Blue Cross Blue Shield network, only to work together in good faith toward a balanced agreement,” CommonSpirit said in a statement on its website. 
    • “The system said that it is willing to continue working toward a new agreement with Anthem but its previous proposals “failed to offer terms that fairly reimburse for services provided to its members, and equitably cover the burden to get reimbursed timely and accurately.”
  • Per Fierce Healthcare,
    • “Uber Health will begin rolling out a new solution designed for caregivers this summer, the company announced at its annual product event Wednesday. 
    • “Uber Caregiver will allow individuals to add a caregiver to their Uber profile. That caregiver can then see and spend that person’s health benefits on eligible services, request rides to doctors’ appointments or order groceries. The caregiver will get real-time updates along the way and have access to a chat feature to communicate with the Uber driver as needed.
    • “Individuals will need to use the Uber app to participate. Uber also offers a way for those who need help to request a ride by calling 1-833-USE-UBER from a phone with texting capabilities. The phone line also supports some health benefits cards.”
  • and
    • “Digital maternal health company Babyscripts announced a partnership Tuesday with Lyft Healthcare to offer sponsored rides for people who are pregnant or postpartum and face barriers to transportation.
    • “Though Babyscripts is a digital-first, tele-maternal health company, it acknowledges that pregnant individuals also need in-person care. 
    • “Access is one of the biggest challenges to maternal health and infant health—and a patient’s outcomes can come down to whether or not they go to their doctor appointments,” Anish Sebastian, CEO and co-founder of Babyscripts, said in a statement.”

Tuesday Tidbits

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Govexec lets us know,
    • “The U.S. Postal Service is pausing some of the most controversial reforms to its mailing network as its leadership has agreed to the demands of a growing, bipartisan chorus in Congress. 
    • “The mailing agency has halted its plans to consolidate dozens of processing facilities until at least Jan. 1, 2025, ensuring the network overhaul is paused until after the upcoming presidential election in which millions of Americans will be voting by mail. A large swath of lawmakers across the ideological spectrum have called on Postmaster General Louis DeJoy to delay or cease the changes, some of which would shift the bulk of mail processing across state lines. 
    • “The decision marks a reversal for DeJoy, who just last week remained resolute in defending his vision as the only viable path forward for his agency. He called the issue an existential one, saying his reforms were “what we must continue to do to survive.” 
  • HHS’s Agency for Healthcare Research and Quality posted its March 2024 “NATIONAL HEALTHCARE QUALITY AND DISPARITIES REPORT CHARTBOOK ON PATIENT SAFETY.”
  • Per an FDA press release, “[o]n Monday [May 13], the FDA issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to an increased risk of false results. The FDA had also issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus.” 

From the public health and medical research front,

  • The Washington Post reports,
    • “The coronavirus has once again evolved, in a familiar echo of past years. Unlike earlier iterations of the virus, this new variant is not sparking widespread havoc.
    • “The Centers for Disease Control and Prevention said it is monitoring a variant called KP.2 and does not see evidence it causes more severe illness than other strains. Laboratory tests have shown that KP.2 is not causing a surge in infections or transmission, the agency said.
    • “The CDC has identified a second emergent variant, KP.1.1. But it is KP.2 that is leading the pack. Both new variants belong to a group of coronavirus variants dubbed “FLiRT” by scientists. The acronym was coined to describe a combination of mutations found in the spike protein of the SARS-CoV-2 virus. * * *
    • “KP.2 has symptoms similar to earlier versions of the virus, including fever, chills, cough and muscle or body aches.”
    • The current vaccines are effective against KP.2. [“H]ealth experts predict that the new formulation of the coronavirus expected for the fall could offer even stronger protection because it will probably be tailored to thwart the new variant.”
  • Beckers Hospital News informs us,
    • “On average, people taking Novo Nordisk’s weight loss drug Wegovy see a 10% reduction in weight, which is sustained for four years, according to findings from a major trial published May 13.  * * *
    • “Wegovy is tied to a 20% reduced risk of heart attacks and other cardiovascular events — a benefit that was seen across the board, irrespective of how much weight people lost.” 
  • STAT News adds,
    • “Novo Nordisk will test whether its GLP-1 drugs can help people with alcohol-associated liver disease, and, as part of that, will study if the treatments will change the amount of alcohol people drink.
    • “This appears to be the first time the company is getting involved in research to see if the booming class of GLP-1 diabetes and obesity drugs can affect substance consumption, a question that academic researchers have been probing but the pharmaceutical industry has so far avoided.
    • “The nine-month study will try three drugs alone and in combinations against placebo. The primary outcome being tested is change in liver scarring, or fibrosis, and one of the secondary outcomes is changes in alcohol consumption. The news of the study was first reported by Bloomberg.
    • “The medications that will be tested include the blockbuster semaglutide, sold as the diabetes drug Ozempic and obesity drug Wegovy, as well as CagriSema, a drug Novo is developing that combines semaglutide with the dual amylin and calcitonin receptor agonist cagrilintide. A third drug, NNC0194-0499, targets FGF-21, a hormone produced by the liver that plays a role in inflammation.”
  • NIH’s All of Us Program posted its latest newsletter.
  • Per an Institute for Clinical and Economic Research press release,
    • “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD). * * *
    • “Key Clinical Findings
    • “Although ICER attempted to explore the concerns raised about MDMA-AP and the MAPP trials, ICER was not able to assess the extent that bias influenced reporting of benefits or the frequency with which there may have been misreporting of harms. As such, ICER concluded that the current publicly available evidence is insufficient (“I”) to assess the overall net benefit of MDMA-AP. 
    • “Key Cost-Effectiveness Findings
    • “Given the “I” rating, the economic analyses of MDMA-AP in this Evidence Report are only exploratory analyses that provide insights into costs and benefits if it is assumed that the results of the MAPP trials are accurate. ICER did not calculate a health-benefit price benchmark for MDMA-AP.”
  • Benefitfocus released an “Employee Benefits Strategy Playbook for Mental Healthcare.

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “The majority of the nation’s leading for-profit hospital systems by revenue reported net gains during the first quarter led by stronger than expected inpatient volumes.
    • “The boost in inpatient volumes and associated revenue comes just a quarter after providers said they would be betting more heavily on outpatient services to drive growth. 
    • “Increases in inpatient revenues is an area to watch as providers weigh whether and how to adjust their portfolios. Community Health Systems, for example, has been on a selling spree recently in an attempt to deleverage its balance sheets, while HCA Healthcare, Tenet Healthcare and Universal Health Services are expanding services in key markets. 
    • “Should inpatient care utilization continue to rise over multiple quarters, it could influence hospitals’ capital spending, according to research notes from analysts.”
  • BioPharma Dive tells us,
    • “Biosimilars are gaining ground. The IRA could push them further next year.
    • “As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.”
  • Modern Healthcare reports,
    • Behavioral health provider Talkspace rolled out services Tuesday to 13 million Medicare members across 11 states and will expand to 33 million members nationwide by the end of the year.
    • Talkspace services are available to those with traditional Medicare in California, Florida, New York, Ohio, New Jersey, Virginia, Missouri, Maryland, South Carolina, New Mexico and Idaho. The company plans to offer services to Medicare Advantage members later on, as well.

Midweek Update

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare, Wellness–

From Washington, DC

  • Modern Healthcare tells us,
    • “Congress took the first step Wednesday to extend expiring telehealth rules, hospital at home services and other programs aimed at rural hospitals.
    • “The House Ways and Means Committee passed the Preserving Telehealth, Hospital, and Ambulance Access Act of 2024 by a vote of 31-0, setting it up for passage by the full House later this year. * * *
    • “One potentially controversial provision in the bill requires pharmacy benefit managers that work with Medicare Part D plans to de-link the compensationthey pay themselves from the rebates they secure based on drugs’ high list prices. Rep. Brad Schneider (D-Ill.) said the provision will save the government about $500 million, although official estimates were not yet available. The provision does not apply to the broader commercial market, though Schneider and Rep. Nicole Malliotakis (R-N.Y.) both called for expansion of the provision to the commercial market. Large PBMs oppose such provisions.”
  • Govexec lets us know,
    • “A new report from the Congressional Budget Office found that a gap between the combined pay and benefits of federal workers and their private sector counterparts has nearly disappeared between 2015 and 2022, raising new questions about President Biden’s proposed 2% average pay raise for the federal workforce in 2025.
    • “Federal policymakers generally rely on one of two reports comparing the compensation of federal and private sector workers. First is an annual analysis compiled by the Bureau of Labor Statistics for review by the Federal Salary Council, which compares only the wages of similar jobs, is the preferred citation of Democrats and federal employee unions. * * *
    • “CBO’s analysis, which is typically conducted every five years and is preferred by conservatives, compares “total compensation”—wages plus the cost of benefits like health care, paid leave and retirement—of federal and private sector employees with similar educational backgrounds. This model has traditionally concluded that the cost of federal employees’ pay and benefits is moderately higher than their counterparts in the private sector, although federal workers with master’s or professional degrees still tend to earn less.
    • “The latest version of CBO’s report, which was released last month, covers only 2022, rather than the traditional 2015-2020 period, due to the economic upheaval caused by the COVID-19 pandemic. It found that the total compensation gap between federal and private sector jobs cratered between 2015 and 2022, falling from 17% in its last analysis to just 5%.”
  • Per May 8 HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is announcing the Increasing Organ Transplant Access (IOTA) Model. The proposed model, which would be implemented by the CMS Innovation Center, aims to increase access to kidney transplants for all people living with end-stage renal disease (ESRD), improve the quality of care for people seeking kidney transplants, reduce disparities among individuals undergoing the process to receive a kidney transplant, and increase the efficiency and capability of transplant hospitals selected to participate. This proposed model would build on the Biden-Harris Administration’s priority of improving the kidney transplant system and the collaborative efforts between CMS and the Health Resources and Services Administration (HRSA) to increase organ donation and improve clinical outcomes, system improvement, quality measurement, transparency, and regulatory oversight.” * * *
    • “The proposed rule on the Increasing Organ Transplant Access Model can be accessed from the Federal Register at https://www.federalregister.gov/public-inspection/current. Standard provisions are included in the proposed rule that would be applicable to all Innovation Center model participants that begin participation in a model on or after January 1, 2025.
    • “View – PDF a fact sheet on the Increasing Organ Transplant Access Model.
    • “More information on the Increasing Organ Transplant Access Model is available on the model webpage.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $46.8 million in notices of funding opportunities to promote youth mental health, grow the behavioral health workforce, improve access to culturally competent behavioral care across the country, and strengthen peer recovery and recovery support. President Biden made tackling the mental health crisis and beating the opioid epidemic key pillars in his Unity Agenda for the nation. Today’s announcement will help communities transform how they address behavioral health.”
  • Beckers Clinical Leadership notes,
    • “Starting this summer, rural health clinics seeking Medicare reimbursement can apply through a new accreditation program from The Joint Commission. 
    • “On May 7, The Joint Commission said it has received deeming authority from CMS for a new rural health clinic accreditation program, which is meant to support patient safety improvements by reducing variation and risks in the delivery of primary care and personal health services.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Geneoscopy received Food and Drug Administration approval for its Colosense noninvasive colorectal cancer screening test, the company said Monday.
    • “The stool-based test, which Labcorp will offer, is approved for screening people aged 45 years or older who are at average risk of developing colorectal cancer. The indication puts Geneoscopy in competition with Exact Sciences’ Cologuard test.
    • “Geneoscopy focused on the opportunity in people aged under 50 years in its statement about the approval. Around 2% of people in that cohort used a stool-based test in 2021, but Evercore ISI and TD Cowen analysts expect Colosense to have a limited impact on Exact.”
  • STAT News points out,
    • “The Apple Watch has secured a new qualification from the Food and Drug Administration that could make the smartwatch an appealing tool for medical device companies hoping to illustrate the benefits of a common heart procedure.
    • “Last week, the Apple Watch’s Atrial Fibrillation History feature became the first digital tool qualified under the Medical Device Development Tools (MDDT) program. Released in 2022, the feature estimates a user’s A-fib burden, or how much time they spend in atrial fibrillation, which is an irregular heart rhythm that can cause shortness of breath and fatigue, and is also linked to an increased risk of stroke.
    • “The qualification means that FDA has determined in advance that sponsors can use the feature as a secondary endpoint in clinical trials without having to do additional work. Specifically, the Apple Watch is qualified for use as a secondary endpoint in clinical trials for cardiac ablation devices, which reduce the electrical signals that cause A-fib by scarring the heart with extreme heat or cold energy. Pulsed field ablation is the latest version of the technology, using a controlled electric field to scar tissue rather than the riskier thermal energy.”
  • Regulatory Focus notes,
    • “The US Food and Drug Administration (FDA) is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs, said Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research (CDER).
    • “Cavazzoni made these remarks during a webinar hosted by the Alliance for a Stronger FDA on Monday, during which, she said “we strongly encourage manufacturers not to stop manufacturing as the result of an inspection.” She added that manufacturers sometimes shut down production lines based on what they are hearing during the inspection, which she said could worsen shortages.”

From the public health and medical research front

  •  The Washington Post reports that “Olive oil use [is] associated with lower risk of dying from dementia. An observational study has found that regular olive oil consumption may have cognitive health benefits.”
    • “Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.”Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.
    • “We don’t believe it’s one compound or two. The olive oil has the phenolic antioxidants, which are very important for protecting against oxidative stress,” Vasiliou said. “But there is a lot of other stuff that’s going on there.”
  • Per MedPage Today,
    • “Use of cannabis and nicotine together during pregnancy was associated with higher risks for infant death and maternal and neonatal morbidity compared with no exposure to either substance, with dual-use risk estimates higher than with either substance alone, a retrospective population-based cohort study.
    • “Compared with use of neither substance, the risk of infant death was more than twice as high with combined use in pregnancy after controlling for possible confounders (adjusted risk ratio [aRR] 2.18, 95% CI 1.82-2.62), reported Jamie O. Lo, MD, MCR, of Oregon Health & Science University in Portland, and colleagues.
    • “By comparison, risks were 65% higher with cannabis use only (aRR 1.65, 95% CI 1.41-1.93) and 62% higher with nicotine use only (aRR 1.62, 95% CI 1.45-1.80) versus no exposure, the researchers detailed in JAMA Network Open.
    • “Lo told MedPage Today in an email that she and her colleagues were surprised to see the increased infant death rate in the combined cannabis and nicotine users compared with those using each substance alone.
    • “We also did not expect so many maternal and neonatal/infant outcomes to be worse with combined cannabis/nicotine use,” she added.”
  • The National Cancer Institute posted its periodic cancer information highlights.
  • The National Institutes of Health announced,
    • The National Institutes of Health (NIH) will launch clinical trials to investigate potential treatments for long-term symptoms after COVID-19 infection, including sleep disturbances, exercise intolerance and the worsening of symptoms following physical or mental exertion known as post-exertional malaise (PEM). The mid-stage trials, part of NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, will join six other RECOVER studies currently enrolling participants across the United States testing treatments to address viral persistence, neurological symptoms, including cognitive dysfunction (like brain fog) and autonomic nervous system dysfunction. The new trials will enroll approximately 1,660 people across 50 study sites to investigate potential treatments for some of the most frequent and burdensome symptoms reported by people suffering from long COVID.
    • “People 18 years of age and older who are interested in learning more about these trials can visit trials.RECOVERCovid.org(link is external) or ClinicalTrials.gov and search identifiers NCT06404047, NCT06404060, NCT06404073, NCT06404086, NCT06404099, NCT06404112.” 
  • BioPharma Dive reports,
    • “A profoundly deaf baby who received Regeneron’s experimental gene therapy was able to hear normally within six months, the company announced Wednesday.
    • “The data, presented at a medical conference, build on initially promising research released in October. The baby was dosed at 11 months of age, one of the youngest children in the world to receive gene therapy for genetic deafness, Regeneron said. A second patient, treated at age 4, also showed hearing improvements at a six-week assessment, the company said.
    • “Both children suffer from a type of deafness caused by mutations in a gene known as otoferlin. The initial research on Regeneron’s DB-OTO therapy is part of an ongoing Phase 1/2 trial known as CHORD enrolling infants and children in the U.S., U.K. and Spain.

From the U.S. healthcare business front,

  • MedCity News informs us,
    • “About a third of employers are integrating value-based care into their employer-sponsored insurance, according to a new survey. Another third of employers are determining the “best-fit strategies for their organization” when it comes to accountable care.
    • “The report was published Sunday by the Milken Institute with support from Morgan Health, a JPMorgan Chase healthcare unit for employer-sponsored insurance. The Milken Institute is a nonprofit think tank focused on financial, physical, mental and environmental health. The survey received responses from 72 employers of varying sizes and industry types.
    • “The researchers found that when making health benefit decisions, expanding preventive care, improving access to primary care and focusing on whole-person health are the top three tenets of accountable care. The lowest-ranked tenets are reducing health outcome disparities and increasing access to digital care.”
  • Fierce Healthcare adds,
    • “Employers are in a strong position to lead the charge in changing the conversation around obesity care, according to a new report from the Milken Institute.
    • “The group released a how-to guide employers of all sizes can use to push for obesity to be recognized as a chronic condition, driving a more multifaceted model for care and addressing the stigma that exists around weight.
    • “The guidebook notes that obesity and conditions related to it are having a major impact on healthcare costs, accounting for $425.5 billion in costs for the civilian workforce, according to a recent study. This includes higher medical costs for both employers and employees as well as costs related to absenteeism.
    • “Sarah Wells Kocsis, director of the Center for Public Health at the Milken Institute and one of the paper’s authors, told Fierce Healthcare that employers are starting to take notice of this issue and lead a conversation that’s “decades in the making.”
    • “We’re really at an inflection point,” she said. “Our goal here is to put this in writing and explain what a strong case there is to think about obesity as a chronic disease.”
  • HealthDay explains,
    • “Worries over health-related costs are plaguing the minds of older Americans of all backgrounds, a new poll suggests.
    • “Five of the six health-related issues that most people found very concerning had to do with health care costs, according to results from the University of Michigan National Poll on Healthy Aging. 
    • “And the sixth issue – financial scams and fraud – also had to do with money, results show.
    • “In this election year, these findings offer a striking reminder of how much health care costs matter to older adults,” Dr. John Ayanian, director of the University of Michigan Institute for Healthcare Policy and Innovation, where the poll is based, said in a news release. The poll is supported by AARP and Michigan Medicine, U-M’s academic medical center.
    • “Overall, 56% of people over 50 said they’re concerned about the cost of medical care for older adults, poll results show.”
  • Per mHealth Intelligence,
    • New research reveals that a text message and telephone-based virtual care approach can improve rates of screening, identification, and treatment of maternal mental health conditions.
    • Published in Health Affairs, the study assessed an intervention that addresses various barriers to adopting maternal mental health screening and referral to treatment. Medical University of South Carolina researchers noted that perinatal mental health disorders, perinatal substance use disorders (SUDs), and intimate partner violence are common during pregnancy and the postpartum year. According to data from the Mental Health Leadership Alliance, maternal mental health conditions affect 800,000 families each year in the United States.
  • BioPharma Dive offers a helpful database of patent expiration dates for thirty top-selling medicines.

Tuesday Tidbits

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

From Washington DC,

  • STAT News tells us
    • “A new bill set to be considered on Wednesday by the House Ways & Means Committee would extend for two years telehealth flexibilities for Medicare enrollees that were adopted during the Covid-19 pandemic, and look to reform drug industry middlemen to pay for it. [FEHBlog note — The bill focuses on PBMs serving Medicare Prescription Drug Plans.]
    • “At the end of the official public health emergency, Congress extended flexibilities that changed where and what kinds of care people could receive over telehealth, but those rules are set to expire at the end of the year.  * * *
    • “Lawmakers discussed reforming PBMs in spending talks earlier this year, but ultimately failed to come to an agreement. The December deadline will be another chance for Congress to take action. * * *
    • “The new bill language will be marked up by lawmakers and may be subject to changes before it receives a vote. A likely path to passage is inclusion in a year-end spending package.”
  • AP reports,
    • “The go-broke dates for Medicare and Social Security have been pushed back as an improving economy has contributed to changed projected depletion dates, according to the annual Social Security and Medicare trustees report Monday.
    • “Still, officials warn that policy changes are needed lest the programs become unable to pay full benefits to retiring Americans. 
    • “Medicare’s go-broke date for its hospital insurance trust fund was pushed back five years to 2036 in the latest report, thanks in part to higher payroll tax income and lower-than-projected expenses from last year. * * *
    • “Meanwhile, Social Security’s trust funds — which cover old age and disability recipients — will be unable to pay full benefits beginning in 2035, instead of last year’s estimate of 2034. Social Security would only be able to pay 83% of benefits.”
  • The New York Times relates,
    • “The White House has unveiled tighter rules for research on potentially dangerous microbes and toxins, in an effort to stave off laboratory accidents that could unleash a pandemic.
    • “The new policy, published Monday evening, arrives after years of deliberations by an expert panel and a charged public debate over whether Covid arose from an animal market or a laboratory in China. * * *
    • “The new policy, which applies to research funded by the federal government, strengthens the government’s oversight by replacing a short list of dangerous pathogens with broad categories into which more pathogens might fall. The policy pays attention not only to human pathogens, but also those that could threaten crops and livestock. And it provides more details about the kinds of experiments that would draw the attention of government regulators.
    • “The rules will take effect in a year, giving government agencies and departments time to update their guidance to meet the new requirements.”

From the public health and medical research front,

  • EHS Today adds,
    • “With the FDA’s approval of naloxone as an OTC drug, workplaces now have access to a lifesaving tool. and therefore, it should be included in workplace first aid kits, says the International Safety Equipment Association (ISEA). ISEA publishes the ANSI/ISEA Z308.1-2021 standard.
    • “According to the U.S. Bureau of Labor Statistics, 525 people died from overdoses at work in 2022
    • “In a March 2024 statement, the White House challenged leaders to increase training and access to opioid overdose reversal medications, keeping the medications in first aid kits, and distributing the medications to employees and customers so they might save a life at home, work, or in their communities.”  
  • Medscape informs us,
    • “All obesity interventions eventually lead to a plateau in weight, where further loss ceases despite ongoing efforts. But the duration of continuous weight loss before hitting a plateau is longer with both glucagon-like peptide 1 (GLP-1) receptor agonist drugs and gastric bypass surgery than with dietary restriction, primarily because they alter how weight loss affects appetite, not energy expenditure.
    • “That’s the conclusion from a new mathematical modeling study based on published data. The study showed that both GLP-1 agonists and Roux-en-Y gastric bypass (RYGB) surgery act to weaken the increase in appetite that normally occurs with time after weight loss attained through dietary restriction alone.
    • “The average time to weight loss plateau occurred within 12 months with dietary restriction vs 24 months in studies of tirzepatide (a dual glucose-dependent insulinotropic polypeptide/GLP-1 agonist), semaglutide, and RYGB, according to Kevin D. Hall, PhD, chief of the integrative physiology section at the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.
    • “The findings were published in Obesity.
    • “Both RYGB and tirzepatide resulted in greater weight loss than semaglutide, but plateau timing of the three was roughly the same at 24 months. “The timing of the plateau is a different question than how much weight they lost,” Hall told Medscape Medical News.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lets us know,
    • “Dallas-based Steward Health Care has placed its 31 U.S. hospitals up for purchase to help offload its $9 billion debt after the health system filed for Chapter 11 bankruptcy, Reuters first reported May 7.
    • “During a court hearing May 7 in Houston, Steward attorney Ray Schrock told U.S. Bankruptcy Judge Chris Lopez that the for-profit health system is aiming to keep all of its hospitals open and to finalize the sale of the facilities by the end of this summer, the news agency reported.
    • “Our goal remains that there are zero hospitals closed on our watch,” Mr. Schrock said, according to Reuters. “There’s going to be a change in ownership in many hospitals, we recognize that. But we don’t want to see any of these communities fail to be served.”
  • Healthcare Dive offers more details on this bankruptcy proceeding.
  • Per Fierce Healthcare,
    • “Telehealth company Amwell continues to struggle in the stock market, and both its bottom- and top-line results in the first quarter missed Wall Street analysts’ estimates.
    • “The company, formerly American Well, brought in revenue of $59.5 million in the first quarter, down 7% from $64 million a year ago, and it reported a quarterly loss of $73.4 million, according to its first-quarter financial results (PDF). That compares to a loss of $398 million during the same quarter last year when it took a hefty impairment charge as a result of its stock market performance. * * *
    • “But, the virtual care giant is plotting accelerated revenue growth and a path to EBITDA profitability in 2026, boosted by a major contract with the Defense Health Agency (DHA).” 

Monday Roundup

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports
    • “Weeks following the news that Office of Personnel Management Director Kiran Ahuja would step down, agency Deputy Director Rob Shriver has been appointed acting director of the federal government’s dedicated HR agency.
    • “Shriver announced the news in a post on LinkedIn. * * *
    • “According to the Vacancies Act, Shriver may serve as acting OPM director for 210 days, or until Dec. 2. If he is ultimately nominated to succeed Ahuja on a permanent basis, he likely will be able to remain in the acting director role during the Senate confirmation process, thanks to his service as her “first assistant” in a Senate-confirmed position.”
  • Federal News Network tells us,
    • “Highlighting the work federal employees and other civil servants perform, and especially noting their efforts in administrating pandemic recovery programs, President Joe Biden expressed his appreciation for public servants across the country. In keeping with tradition, the White House issued a proclamation that May 5 will mark the beginning of Public Service Recognition Week.
    • “PSRW is traditionally celebrated the first full week of May. Many federally-focused organizations, including the National Active and Retired Federal Employees Association, show appreciation for public servants during the month of May.”
  • Govexec adds,
    • “Sammie Tafoya, a foreign service officer assigned to Haiti, said she didn’t know what the State Department was when her African history professor encouraged her to apply to work there. 
    • “Whenever I wrote for his class, he said…‘I think what you are looking for — the idea of being able to push change and to be able to write to inform the people that have power to make policies — there’s actually an agency for that. It’s the State Department. It’s the Foreign Service,’” she said. 
    • “Tafoya is one of 25 finalists announced Monday for the Partnership for Public Service’s 2024 Service to America Medals. Nicknamed the Sammies after the award’s namesake, Samuel J. Heyman, who founded the nonpartisan organization, the program has been around since 2002 and honors excellence and innovation in the career federal service. 
    • “The finalists will be recognized at a reception on Thursday, and winners will be announced ahead of an awards ceremony on Sept. 11 at the Kennedy Center.  * * *
    • “A full list can be found here.” 
  • The Society for Human Resource Management informs us,
    • “On May 3, President Joe Biden vetoed a resolution to overturn the National Labor Relations Board’s (NLRB’s) joint employer rule. However, the rule has been blocked by a federal district court in Texas, and litigation might continue.
    • “Overcoming the veto by a two-thirds majority vote in the Senate and House of Representatives is unlikely. The resolution passed the House by a 206-177 vote on Jan. 12 and cleared the Senate by a 50-48 vote on April 10. SHRM had urged Biden not to veto the measure.”

From the public health and medical research front,

  • The New York Time reports,
    • “Scientists are proposing a new way of understanding the genetics of Alzheimer’s that would mean that up to a fifth of patients would be considered to have a genetically caused form of the disease.
    • “Currently, the vast majority of Alzheimer’s cases do not have a clearly identified cause. The new designation, proposed in a studypublished Monday, could broaden the scope of efforts to develop treatments, including gene therapy, and affect the design of clinical trials.
    • “It could also mean that hundreds of thousands of people in the United States alone could, if they chose, receive a diagnosis of Alzheimer’s before developing any symptoms of cognitive decline, although there currently are no treatments for people at that stage.
    • “The new classification would make this type of Alzheimer’s one of the most common genetic disorders in the world, medical experts said.”
  • and
    • “A new study, published Saturday in The Journal of the American Medical Association, revealed growing disparities in child death rates across racial and ethnic groups. Black and Native American youths ages 1 to 19 died at significantly higher rates than white youths — predominantly from injuries such as car accidents, homicides and suicides.
    • “Dr. Coleen Cunningham, chair of pediatrics at the University of California, Irvine, and the pediatrician in chief at Children’s Hospital of Orange County, who was not involved in the study, said the detailed analysis of the disparities documented “a sad and growing American tragedy.”
    • “Almost all are preventable,” she said, “if we make it a priority.”
  • The Wall Street Journal discusses efforts in the U.S. to eliminate cervical cancer using the HPV vaccine.
    • “Doctors are rallying around an audacious goal: eliminating a cancer for the first time. 
    • “Cervical cancer rates in the U.S. have dropped by more than half since the 1970s. Pap tests enable doctors to purge precancerous cells, and a vaccine approved in 2006 has protected a generation of women against human papillomavirus, a sexually transmitted infection that causes more than 90% of cervical cancers. 
    • “With this evidence that the disease is preventable, groups that have worked for decades to end polio and malaria are turning to cervical cancer, plotting to take cases down to null. The World Health Organization is urging countries to boost vaccination, screening and treatment. Doctors in the U.S. are working on a national plan.” 
  • Beckers Hospital Review lets us know,
    • “A 12-year-old boy is the first commercial patient in the world to receive an FDA-approved gene therapy for sickle cell disease, The New York Times reported May 6.
    • “Kendric Cromer is a 12-year-old boy from the suburbs of Washington, D.C., and the first to receive Lyfgenia, a gene therapy treatment created by Somerville, Mass.-based Bluebird Bio. Kendric’s treatment, which costs about $3.1 million, is covered by his family’s insurance. He underwent the first part of treatment at Washington, D.C.-based Children’s National Hospital, in which physicians removed his bone marrow stem cells, which Bluebird will genetically modify for his treatment. The modified cells will be returned in three months.
    • “The FDA gave two companies authorization to sell gene therapy to people with sickle cell disease, a genetic disorder that affects roughly 100,000 people, most of them Black. 
    • “Bluebird estimates it can only treat 85 to 105 patients each year with sickle cell or beta thalassemia, who can receive a similar gene therapy. Children’s National, meanwhile, said it can accept only 10 gene therapy patients a year.”
  • The American Medical Association points out “What doctors wish patients knew about osteoporosis.”
  • The National Institute for Mental Health updated its website about coping with traumatic events.
  • The Washington Post notes, Ultrasound technology is used in many ways. Addiction is the next frontier. The use of the high-frequency sound waves is also being adapted to treat Alzheimer’s disease, tumors and psychiatric disorders.

From the U.S. healthcare business front,

  • Fierce Healthcare offers a look at how “major payers fared in a Q1 dragged by a cyberattack, MA challenges,” and Beckers Payer Issues ranks major payers by first quarter 2023 and 2024 medical loss ratios.
  • Beckers Payer Issues discusses major Medicare Advantage insurer plans for 2025.
  • Healthcare Dive reports,
    • “Dallas-based Steward Health Care, the largest physician-led hospital operator in the country, filed for Chapter 11 bankruptcy this morning in the U.S. Bankruptcy Court for the Southern District of Texas, following months of financial struggles including missed payments to its landlord and vendors.
    • “Steward operates more than 30 hospitals across eight states, according to a spokesperson for the company. The filing marks the largest provider bankruptcy in decades, according to Laura Coordes, professor of law at the Sandra Day O’Connor College of Law at Arizona State University.” 

Friday Factoids

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • A Senate Finance Committee tells us,
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon) released a legislative proposal to address persistent economic problems leading to shortages of generic medicines plaguing America’s health care system, including chemotherapy drugs and ADHD medications. * * *
    • “The proposal, released as a discussion draft, would establish a new program in Medicare for hospitals and physicians to incentivize transparent, reliable, and resilient purchasing practices across supply-chain participants, including by driving health care providers, intermediaries (such as group purchasing organizations, or GPOs) and drug manufacturers to meet ambitious, proactive standards in securing a sustainable, high-quality supply of essential medicines for patients from all walks of life. * * *
    • “A one-page summary of the discussion draft can be found here.
    • “A section-by-section summary can be found here.
    • “The legislative text can be found here.”
  • STAT News reports,
    • “Members of Congress appear poised to advance another short-term [two year] extension of pandemic-era telehealth flexibilities instead of permanently addressing the issue, seven sources familiar with the talks said.
    • “During the Covid-19 pandemic, lawmakers allowed Medicare patients to access telehealth services in more places and with a greater variety of providers than before, but some of those flexibilities are set to expire at the end of the year. The expiration is expected to be an impetus for a broader health care package in December, when other public health programs also run out. * * *
    • “The House Ways & Means Committee is planning to mark up a two-year telehealth policy extension next week, per five sources familiar with the planning. Politico first reported the markup. According to two sources, the markup will contain entirely new language than is in the dozen or so bills that have been circulated so far.”
  • The U.S. Office of Personnel Management’s final Postal Service Health Benefits Program (PSHBP) implementation rule appeared in the Federal Register’s Public Inspection list today. The final rule will be published in the Federal Register on Monday May 6.
    • “OPM is making several changes between the interim final rule and this final rule:
      • “In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as ofJanuary 1, 2025” includes events that occur on January 1, 2025.”
      • In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as of January 1, 2025” includes events that occur on January 1, 2025.
      • “Section 890.1604(c) is reserved in anticipation of future rulemaking. [FEHBlog note — This provision creates exceptions from the Medicare Part B enrollment mandate for certain PSHBP enrollees and family members.]
      • “In § 890.1604(e), OPM is clarifying that a Postal Service annuitant or their family member who is required to be enrolled in Medicare Part B must promptly notify OPM or the Postal Service, in writing, if they choose not to enroll in or to disenroll from Medicare Part B.
      • “In § 890.1604, OPM is removing reference to the Postal Service as the entity to receive documentation of overseas residency to qualify for an exception to the Part B enrollment requirement.
      • “In § 890.1606(e), OPM is correcting a typographical error by removing the word “the” before “January 1 of the next year.”
  • A proposed follow-up PSHBP rule is pending review at OMB’s Office of Information and Regulatory Affairs. OPM further explains in the preamble.
    • “Topics OPM plans to address in more detail in the proposed rule include: reconsideration of initial decisions concerning PSHB eligibility; application of the Medicare Part B requirement and associated exceptions in specific scenarios; allocation of Reserves credits; calendar year alignment of government contribution requirements; financial reporting and actuarial calculations; premium payment prioritization from the Postal Service Retiree Health Benefits Fund; and Medicare Part D integration.” 
  • CMS also released a No Surprises Act user guide for resubmission of certain IDR cases.
    • “This user guide provides an overview of the “Notice of IDR Initiation – Resubmission” web form and the steps for successfully completing and submitting the web form. This user guide is intended to assist parties who have submitted a dispute through the Federal Independent Dispute Resolution (IDR) process and received an email from Auto-Reply-FederalIDRQuestions@cms.hhs.gov with a link to the “Notice of IDR Initiation – Resubmission” web form.
    • “The “Notice of IDR Initiation – Resubmission” web form will be sent to the initiating party if the certified IDR entity’s eligibility review of a dispute determines that one or more of the dispute line items must be resubmitted because it was improperly batched or bundled. The initiating party must complete the “Notice of IDR Initiation – Resubmission” web form by the deadline specified in the email. The non-initiating party will not need to take any action.”

From the public health and medical research front,

  • The Centers for Disease Control informs us on May 3:
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity. Last week one jurisdiction experienced moderate activity. No jurisdictions experienced high or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.”
  • NBC News reports,
    • “New research suggests patients with an average risk of colon cancer may only need to undergo a colonoscopy screening every 15 years instead of the recommended 10. 
    • “Swedish researchers found that waiting an extra five years after a first negative colonoscopy carried about the same risk of later having a colorectal diagnosis or dying from the disease as getting screened every 10 years. Extending screening time could reduce “unnecessary invasive examinations,” according to the study published Thursday in JAMA Oncology.  * * *
    • “In an editorial accompanying the new study, gastroenterologists suggested that future screening guidelines may safely be prolonged for some people, noting that “15 has the potential to be the new 10.” * * *
    • “We do not have enough gastroenterology doctors to do a colonoscopy every 10 years in everyone over 50,” said Dr. Otis Brawley, the Bloomberg distinguished professor of oncology and epidemiology at Johns Hopkins University, who was not associated with the new research. * * *. 
    • “Employing cheaper, less invasive screening methods 10 to 15 years after a negative colonoscopy could greatly reduce the number of missed screenings, said the study’s lead author, Dr. Mahdi Fallah, head of the Risk Adapted Cancer Prevention Group at the German Cancer Research Center in Heidelberg. 
    • “The best screening test is the one that is actually done. So, if a test like colonoscopy is unaffordable for a person, an alternative cheaper valid test is much better than no test at all,” said Fallah, who is also a visiting professor in the department of clinical sciences at Lund University in Sweden.”
  • The Institute for Clinical and Economic Review announced on May 2,
    • “[We] will assess the comparative clinical effectiveness and value of tabelecleucel (“tab-cel”, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2024, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“

From the U.S. healthcare business front,

  • Kaufmann Hall announced on May 2,
    • “[Hospital m]argins and volumes declined slightly in March, which may signal more challenges ahead. Hospital outpatient revenue also fell 5%, reflecting the competitive challenges of providing outpatient care.
    • “The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for the month of March was 3.9%.
    • “The April issue of the National Hospital Flash Report covers these and other key performance metrics.
  • and
    • “Overall labor expenses and revenue continue to rise, and Q1 2024 data show that labor represented 84% of total expenses. The median investment/subsidy per provider increased 2% compared to Q1 2023.
    • “The [Q1] Physician Flash Report features the most up-to-date industry trends drawn from the same data physician groups use to track their finances and operations.”
  • Beckers Hospital Review compares Spring 2024 Leapfrog Hospital Safety Grades against CMS Star ratings for hospitals receiving high and low Leapfrog grades.
  • BioPharma Dive notes,
    • “Amgen shares soared by double digits Friday following its announcement an obesity drug it’s developing has shown enough promise to warrant advancing into late-stage testing.
    • “On an earnings call with analysts Thursday, CEO Robert Bradway said the company is “confident” in the drug’s “differentiated profile” following an internal review of interim Phase 2 study results. Full data are expected by the end of the year and should support a subsequent move into Phase 3 trials, executives said.
    • “Yet Amgen’s drug is likely at least two years away from regulators’ desks, by which time Eli Lilly and Novo Nordisk may already have successors to their weight loss medicines Wegovy and Zepbound. It will take even more time to accumulate data to prove the drug can protect heart health, a key claim for convincing commercial and federal insurers to reimburse for treatment.”
  • Healthcare Dive lets us know,
    • “Walgreens has inked a clinical trial deal with major German drugmaker Boehringer Ingelheim.
    • “Under the deal, Walgreens will find candidates who are overweight or have obesity or diabetes and connect them with a Phase III clinical trial for Boehringer’s GLP-1 drug survodutide, according to a release.
    • “Walgreens launched its clinical trials business in 2022 as part of the company’s broader pivot to health services. Since then, Walgreens has notched more than 35 clinical trials deals with life sciences companies, according to a spokesperson.”

Midweek Update

David Ermer–FDA, Medicare, NIH, No Surprises Act, Patient safety, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

From Washington, DC,

  • The No Surprises Act regulators alert us,
    • “On October 6, 2023, the Departments and OPM issued FAQs About Consolidated Appropriations Act, 2021 Implementation Part 62 (FAQs Part 62). In FAQs Part 62, the Departments and OPM acknowledged the impact of the TMA III decision on QPAs and the significant resources and challenges associated with recalculating QPAs. Therefore, the FAQs stated that the Departments and OPM would exercise their enforcement discretion under the relevant No Surprises Act provisions for any plan or issuer, or party to a payment dispute in the Federal IDR process, that uses a QPA calculated in accordance with the methodology under the July 2021 interim final rules and guidance in effect immediately before the decision in TMA III, for items and services furnished before May 1, 2024, the first day of the calendar month that is 6 months after the issuance of FAQs Part 62. Under FAQs Part 62, this exercise of enforcement discretion applies to QPAs for purposes of patient cost sharing, providing required disclosures with an initial payment or notice of denial of payment, and providing required disclosures and submissions under the Federal IDR process.
    • “FAQs Part 62 stated that HHS would also exercise enforcement discretion under the relevant No Surprises Act provisions for a provider, facility, or provider of air ambulance services that bills, or holds liable, a participant, beneficiary, or enrollee for a cost-sharing amount based on a QPA calculated using the aforementioned method.”
    • The regulators have extended the safe harbor to services or supplies rendered before November 1, 2024. The regulators do not expect to further extend the safe harbor.
  • The Wall Street Journal reports,
    • “As part of the government’s quest to improve American eating habits, the Food and Drug Administration is considering requiring food manufacturers to put new labels on the front of packages. The labels might flag certain health risks, such as high levels of salt, sugar or saturated fat.
    • “Don’t expect to see a warning label in your grocery store soon, because the FDA is still weighing its approach. But the agency hopes that clearer food labeling could help us make healthier choices as it tackles the rise of diet-related health problems such as Type 2 diabetes and cardiovascular disease.” 
  • Fierce Healthcare discusses the new HHS rule here.

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two decades ago, the shocking results of a major women’s health study challenged the safety of menopause hormones, and overnight, millions of women and their doctors abandoned the drugs — a reluctance that lingers today.
    • “Now, a long-term follow-up of the Women’s Health Initiative (WHI) shows that the reaction was largely overblown. The new research found that for many younger menopausal women — typically those under 60 — the benefits of the drugs probably outweigh the risks for the short-term treatment of menopause symptoms, including hot flashes and night sweats.
    • “The new analysis, published in JAMA, shows that younger women starting menopause and experiencing symptoms can take hormone treatments for several years with a lower likelihood of adverse effects.
    • “Women in early menopause with bothersome symptoms should not be afraid to take hormone therapy to treat them, and clinicians should not be afraid to prescribe them,” said JoAnn Manson, chief of the division of preventive medicine at Brigham and Women’s Hospital and the paper’s first author.”
  • The New York Times informs us,
    • “Baby aspirin is routinely prescribed to people who survive heart attacks. But there’s another vulnerable group who benefit from daily low-dose aspirin: pregnant women at risk of developing pre-eclampsia, life-threatening high blood pressure.
    • “It’s a factor in up to one in 20 pregnancies in the United States, and one of the leading causes of maternal mortality nationwide. Pre-eclampsia is the top cause of maternal death among Black women, who die of pregnancy-related complications at rates almost triple those of white women.
    • “But not enough pregnant women are getting the word that low-dose aspirin can help. Now leading experts are hoping to change that.”
  • STAT News tells us,
    • “Extensive testing of pasteurized commercially purchased milk and other dairy products from 38 states has found no evidence of live H5N1 bird flu virus, Food and Drug Administration officials said at a press briefing Wednesday.
    • “The results confirmed findings of earlier testing of a more limited number of samples and add weight to the FDA’s conclusion that pasteurized milk products are safe for consumption despite a widespread outbreak of cows infected with H5N1.
    • “These additional, preliminary results further affirm the safety of the U.S. commercial milk supply,” Donald Prater, acting director of the FDA’s Center of Food Safety and Applied Nutrition, told reporters.”
  • The National Institutes of Health announced,
    • “Recurring feelings of anger may increase a person’s risk of developing heart disease by limiting the blood vessels’ ability to open, according to a new study supported by the National Institutes of Health. The study, published in the Journal of the American Heart Association (JAHA), shows for the first time that anger is linked to this vascular impairment — a precursor to the kind of long-term damage that can lead to heart attack and stroke.
    • “We’ve long suspected, based on observational studies, that anger can negatively affect the heart. This study in healthy adults helps fill a real knowledge gap and shows how this might occur,” said Laurie Friedman Donze, Ph.D., a psychologist and program officer in the Clinical Applications and Prevention Branch of the National Heart, Lung, and Blood Institute (NHLBI), which funded the study. “It also opens the door to promoting anger management interventions as a way to potentially help stave off heart disease, the leading cause of death in this country.”
    • “While a brief spurt of occasional anger is normal and generally has a benign impact on the heart, it is recurring or frequent anger the researchers said raises concern. “If you’re a person who gets angry all the time, you’re having chronic injuries to your blood vessels,” said study leader Daichi Shimbo, M.D., a cardiologist at Columbia University Irving Medical Center in New York City. “It’s these chronic injuries over time that may eventually cause irreversible effects on vascular health and eventually increase your heart disease risk.”

From the U.S. healthcare business front,

  • Healthcare Dive notes,
    • “CVS had a significantly worse first quarter than the healthcare giant — or Wall Street — expected, after its insurance arm failed to adequately prepare for seniors’ high use of medical care, especially in inpatient facilities.
    • “The Rhode Island-based company’s health services segment — usually a reliable driver of growth — also saw its revenue and income fall in the quarter as its pharmacy benefit manager adjusted to the loss of a major contract with insurer Centene.
    • “CVS slashed its earnings expectations for 2024 on Wednesday following the results. It’s the second time the company has lowered financial expectations this calendar year.” 
  • Fierce Healthcare adds,
    • “CVS has quietly acquired Hella Health, a startup Medicare Advantage (MA) broker based in New York City, according to a post on LinkedIn.
    • “Financial terms of the deal were not disclosed, but Hella Health CEO and founder Rafal Walkiewicz wrote in the post that the combination allows the healthcare giant to further bolster its suite of technology platforms, especially those offered directly to the senior population.
    • “Through this combination, CVS Health will expand its multi-payer technology platform to include a wide range of insurance offerings, supported by trusted advisors and agents, to provide a simple, direct-to-consumer Medicare shopping and enrollment experience,” Walkiewicz wrote.”
  • The Leapfrog Group released its Spring 2024 Hospital Safety Grades.
  • Per BioPharma Dive,
    • “GSK on Wednesday raised its financial forecasts for the year following strong quarterly sales of its vaccines and HIV medicines. 
    • “GSK said vaccine sales surged 16% compared to the same period a year ago, a number driven by revenue totals for its shingles shot Shingrix and RSV vaccine Arexvy. New public immunization programs in Europe and other international market drove sales of Shingrix, while Arexvy continued to take more market share than Pfizer’s rival RSV shot Abrysvo.  
    • “The company now expects its 2024 sales to grow at the higher end of the 5% to 7% range it previously projected, and for annual adjusted earnings per share to climb 8% to 10%. Still, GSK warned that growth could slow later this year amid shifting seasonal patterns for vaccinations and changes in market dynamics.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, Mental health care, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Healthcare Dive informs us,
    • “Providers and drugmakers are once again at odds over the 340B drug discount program: this time, over a rule finalized by the Biden administration on Thursday making changes to its dispute resolution process.
    • “The final rule, which will become effective in mid-June, is meant to make dispute resolution more accessible and efficient, according to the Health Resources and Services Administration, or HRSA, the agency that oversees 340B. Along with lowering barriers to enter the process, the rule requires parties to make a good faith effort to resolve disputes before bringing them to arbiters and creates an appeals process if either party doesn’t like the result.
    • “Provider groups the American Hospital Association and 340B Health said the rule should streamline the arbitration process and preserve the integrity of the controversial program. Meanwhile, pharmaceutical lobby PhRMA said the new process “panders to 340B hospitals” while ignoring drugmakers’ concerns.”
  • KFF lets us know,
    • “Federal data from 2019 shows just 4% of potentially eligible enrollees participated in the program, a figure that appears to have held steady through 2023, according to a Mathematica analysis. About 12,000 physicians billed Medicare under the CCM mantle in 2021, according to the latest Medicare data analyzed by KFF Health News. (The Medicare data includes doctors who have annually billed CCM at least a dozen times.)
    • “By comparison, federal data shows about 1 million providers participate in Medicare.
    • Even as the strategy has largely failed to live up to its potential, thousands of physicians have boosted their annual pay by participating, and auxiliary for-profit businesses have sprung up to help doctors take advantage of the program. The federal data showed about 4,500 physicians received at least $100,000 each in CCM pay in 2021. * * *
    • “This program had potential to have a big impact,” said Kenneth Thorpe, an Emory University health policy expert on chronic diseases. “But I knew it was never going to work from the start because it was put together wrong.”
    • “He said most doctors’ offices are not set up for monitoring patients at home. “This is very time-intensive and not something physicians are used to doing or have time to do,” Thorpe said.”
  • Reg Jones offers “A Refresher Course on FEGLI Life Insurance” in FedWeek.

From the public health and medical research front,

  • The Centers for Disease Control reports today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, 2 jurisdictions experienced high activity compared to 1 jurisdiction experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.  
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.” 
  • The National Institutes of Health announced,
    • “Despite Food and Drug Administration (FDA)-approval of seven next-generation antibiotics to fight infections caused by resistant “gram-negative” bacteria, clinicians frequently continue to treat antibiotic-resistant infections with older generic antibiotics considered to be less effective and less safe, according to a study by researchers at the National Institutes of Health’s (NIH) Clinical Center. Researchers examined the factors influencing doctors’ preference for newer antibiotics over traditional generic agents to shed light on the decision-making processes among clinicians when treating patients with challenging bloodstream infections caused by gram-negative bacteria and significant comorbidities.
    • “The study revealed that at a considerable proportion of hospitals, particularly smaller facilities located in rural areas, staff were reluctant to adopt newer antibiotics. Researchers identified a large cost disparity between older and newer classes of antibiotics; the newer drugs can cost approximately six times more than the older medications, which could disincentivize prescribing.
    • “Researchers also highlight that next-gen agents are prescribed more often at hospitals where lab results that show the medications are effective against a patient’s bacterial infection are reported to prescribers. Scientists suggest that earlier and more widespread availability of such lab testing might improve use. Additionally, authors recommend that future public health policies and economic strategies on further development and use of similar antibiotics should be designed to identify and overcome additional barriers.
    • “Gram-negative bacteria are a class of bacteria resistant to multiple drugs and increasingly resistant to most antibiotics. According to the Centers for Disease Control and Prevention, they are able to find new paths of resistant and pass along genetic material that enables other bacteria to become drug resistant.”
  • The American Hospital Association News adds,
    • “In clinical trials involving 220,000 patients at 59 HCA Healthcare hospitals, algorithm-driven computerized alerts helped clinicians better identify the appropriate antibiotic for 28% of patients with pneumonia and 17% of patients with urinary tract infections, according to studies funded by the Centers for Disease Control and Prevention published April 19 in JAMA. To reduce antibiotic resistance, physicians treating patients with a low risk for antibiotic-resistant bacteria were prompted to give standard-spectrum antibiotics.”In clinical trials involving 220,000 patients at 59 HCA Healthcare hospitals, algorithm-driven computerized alerts helped clinicians better identify the appropriate antibiotic for 28% of patients with pneumonia and 17% of patients with urinary tract infections, according to studies funded by the Centers for Disease Control and Prevention published April 19 in JAMA. To reduce antibiotic resistance, physicians treating patients with a low risk for antibiotic-resistant bacteria were prompted to give standard-spectrum antibiotics.
    • “Pneumonia and urinary tract infections are two of the most common infections requiring hospitalization and a major reason for overuse of broad-spectrum antibiotics,” said Sujan Reddy, M.D., medical officer in CDC’s Division of Healthcare Quality Promotion. “The INSPIRE trials have found a highly effective way to help physicians follow treatment recommendations to optimize antibiotic selection for each patient. These trials show the value of harnessing electronic health data to improve best practice.”
  • Health IT Analytics tells us,
    • “Artificial intelligence (AI)-driven tools can improve the skin cancer diagnostic accuracy of clinicians, nurse practitioners and medical students, according to a study published last week in npj Digital Medicine.
    • “The researchers underscored that AI-based skin cancer diagnostic tools are developing rapidly, and these tools are likely to be deployed in clinical settings upon appropriate testing and successful validation.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Alvotech and U.S. commercial partner Teva have signed a “long-term agreement” with an unspecified company to boost access to their biosimilar version of AbbVie’s blockbuster drug Humira, Alvotech said Friday. An Alvotech spokesperson declined to provide specifics.
    • “The deal comes seven weeks after the Food and Drug Administration approved Alvotech’s biosimilar, Simlandi, which the agency previously rejected multiple times. For patients to receive treatment, Alvotech and Teva must first cut deals with drug wholesalers, pharmacies and insurers that negotiate prices before agreeing to cover the therapy.
    • “CVS Health, whose pharmacy benefit manager is the country’s largest by prescription claims, removed Humira from its national formularyon April 1. Wall Street analysts have already reported substantial declines in Humira prescriptions over the last few weeks, when compared to the same period in 2023.”
  • According to Beckers Hospital Review,
    • “Change Healthcare has reinstated 80% of the functionality for its claims, payment and pharmacy services following a February ransomware attack, the company said.
    • “Those three areas represent most of Change Healthcare’s customers and continue to be restored, according to an April 16 earnings call from parent company UnitedHealth Group.
    • “Now we’ve still got work to do,” said Roger Connor, CEO of OptumInsight, the UnitedHealth unit that includes Change, during the call. “We’ve got another set of products coming online … in the coming weeks, but pleased with that progress.”
  • The AHA News reports,
    • “Patients went out-of-network 3.5 times more often to see a behavioral health clinician than a medical/surgical clinician in 2021, and up to 20 times more often for certain behavioral health visits, according to a new study by RTI International. For example, patients went out-of-network 8.9 times more often to see a psychiatrist, 10.6 times more often to see a psychologist, 6.2 times more often for acute behavioral inpatient care, and 19.9 times more often for sub-acute behavioral inpatient care.”
  • The Wall Street Journal reports,
    • “Social media is displacing physicians as the trusted authorities on whether patients should take one of the medicines. People are not only deciding to take a weight-loss drug—called GLP-1s— based on posts by friends and influencers but sometimes also skipping their doctor to go with one mentioned online.
    • “The virtual word-of-mouth can come across as authentic and accessible. People say they appreciate the tips and support they get from other online users. But many influencers and friends on social media play up all the pounds a person lost while playing down side effects that can be nasty, such as painful headaches and bouts of vomiting. Some omit the risks altogether.
    • “Unlike company drug advertisements, social-media posts don’t have to describe a drug’s side effects, suggest other resources or tell people to speak with their doctors.”
  • Ruh roh. This is why health plans are offering coaching services to these folks.