Tuesday Tidbits

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Tuesday Tidbits

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • MedPage Today tells us,
    • Senators and experts on Tuesday examined the range of tools that brand-name drug manufacturers have used to keep generic and biosimilar competition at bay — from patent thickets and product hopping to “pay-for-delay” settlements — and wrestled with how to prevent such abuses.
    • “Too often the prices charged by Big Pharma do not reflect a scientific advancement,” argued Sen. Dick Durbin (D-Ill.), during a Tuesday hearing of the Senate Committee on the Judiciary. “Rather, they’re the result of skilled lawyers manipulating the patent system and skirting our nation’s competition laws.”
  • The Department of Health and Human Services announced,
    • “The Biden-Harris Administration is committed to lowering health care costs, promoting innovation, and making sure that taxpayer investments result in advancements in biomedical research that are accessible to everyone across the country.
    • “Today, the National Institutes of Health (NIH) issued a first of its kind draft policy proposal to promote equitable access to products stemming from NIH-owned inventions. By requiring organizations partnering with the NIH through patent license agreements to outline detailed plans for patient access to drugs, biologics, vaccines, or devices developed from NIH-owned inventions, we are accelerating how breakthroughs in medical research originating from the NIH’s Intramural Research Program can translate into affordable and sustainable solutions for patients across the country. NIH has released a request for information and welcomes public input to inform this new policy.”
  • The American Hospital News informs us,
    • “The Centers for Medicare & Medicaid Services May 21 announced that individuals now have the option to file an Emergency Medical Treatment and Labor Act complaint directly with the agency, in addition to the traditional process of contacting state survey agencies. The new form is the latest in a series of new resources from CMS to help educate the public about EMTALA.” 

From the public health and medical research front,

  • Beckers Hospital Review points out,
    • “The CDC is asking health officials in all 50 states to continue monitoring the prevalence of influenza as H5N1 bird flu infections among poultry and livestock increase and have begun to prompt concern over the possibility of human-to-human transmission, according to a news release shared with Becker’s.”The CDC is asking health officials in all 50 states to continue monitoring the prevalence of influenza as H5N1 bird flu infections among poultry and livestock increase and have begun to prompt concern over the possibility of human-to-human transmission, according to a news release shared with Becker’s.
    • “As of May 21, there has only been one confirmed human infection of the current H5N1 outbreak in a dairy farm employee in Texas, but no evidence of human-to-human transmission.”
  • KFF adds a report titled “Who is at Risk Amid the H5N1 Influenza Outbreak? Characteristics and Health Coverage of Animal Production Workers.”
  • The Blue Cross Blue Shield Association lets us know,
    • “Despite the explosion in demand for weight loss drugs known as GLP-1s, 58% of patients discontinue use before reaching a clinically meaningful health benefit. This is the key finding from new researchreleased by the Blue Cross Blue Shield Association (BCBSA) and conducted by Blue Health Intelligence® (BHI) based on data from nearly 170,000 commercial health plan members since the first FDA approval for a weight-loss GLP-1 in 2014.  
    • “When patients take medication, we want it to be safe and effective,” said Razia Hashmi MD, MPH, FAAFP, vice president of Clinical Affairs at BCBSA. “This study shows most people are unlikely to see lasting benefits.  Unfortunately, weight loss isn’t as simple as filling a prescription.”
    • “In the largest study using commercial data to date on this topic, BHI’s assessment also found that 30% of patients discontinued use of the medications within the first month. 
    • “This study underscores how much more we have to learn about these medications,” said Kim Keck, president and CEO of BCBSA. “The science behind these drugs is moving faster than our ability to truly understand which patients will benefit, how to sustain their success and how to pay for them. If we don’t get it right, we will drive up costs for everyone with little to show for it.” 
  • STAT News reports,
    • “Hundreds of genetic variants can nudge someone’s risk of breast cancer up or down or towards a particular subtype. The studies identifying those gene variants, though, have largely involved people with European ancestry and thus give a less accurate picture of breast cancer risk for people who are not white.
    • “That’s beginning to change. Last week, researchers published a genome-wide association study on breast cancer in roughly 40,000 people of African descent in Nature Genetics, marking a leap forward in scientists’ knowledge of breast cancer genetics in people of African ancestry.
    • “Before we started this study in 2016, there were just several thousand cases for Black Americans. It was a very small number,” said Wei Zheng, the study’s senior investigator and a cancer epidemiologist at Vanderbilt University. This study combined data from dozens of other studies and included genetic data for thousands of new participants, making it the largest combined breast cancer genetics study done with people with African ancestry.
    • “Specifically, the study compiled data from about 30 different studies investigating breast cancer in African or African American people. About 18,000 of them had breast cancer, while the other 22,000 were healthy controls, and investigators were able to scour their genetic data for specific variations that seemed closely related to breast cancer. The statistical power that comes with such numbers enabled the team to make two key advances.
    • “First, the team found 12 loci, or locations in the genome, that showed a significant association with breast cancer. Of those, the team identified variants of three genes that appear to increase the risk of triple negative breast cancer, one of the most aggressive subtypes. Since everyone has two copies or alleles of each gene, that means someone could have anywhere between one and six risk-related alleles of these three genes. Those who had all six risk-related alleles had roughly double the chance of getting triple negative breast cancer than those who only had three. * * *
    • “The other advance came when the researchers used the data to build a breast cancer risk prediction model for people with African ancestry. Such models take into account hundreds of different genetic variants that can slightly push breast cancer risk up, adding them all up into a polygenic risk score.”
  • The Wall Street Journal relates,
    • GSK’s experimental drug for asthma met its goals in the latest trial, moving a treatment with potential annual peak sales of more than 3 billion pounds ($3.81 billion) closer to market.
    • The British pharmaceutical company’s depemokimab drug reduced asthma attacks in late-stage trials for patients with severe eosinophilic asthma, a form of the disease caused by high levels of white blood cells, GSK said Tuesday.
    • Depemokimab could be the first approved drug to allow a long-term dosing interval, requiring only two injections a year. This would benefit patients exposed to multiple therapies, the company said.
    • GSK plans to submit the drug for approval for severe asthma in the U.S. in the second half of the year.
  • Per MedTech Dive,
    • “The Food and Drug Administration is seeking examples of artificial intelligence and machine learning models that can identify and predict freezing of gait events related to Parkinson’s disease. 
    • “Freezing of gait is a temporary loss of forward movement while walking. These episodes affect people’s quality of life and daily activities, but they can be difficult to measure because they often happen when patients are outside of a clinic or hospital setting. 
    • “By testing these models against its own data, the FDA hopes to better understand the ability of these technologies to provide digitally derived endpoints that could help with early disease detection and prevention or support treatment and care in the home.” 
  • From the U.S. healthcare business front,
  • Milliman tells us, “In 2024, the cost of healthcare for a hypothetical American family of four in a typical employer-sponsored health plan is $32,066, according to the Milliman Medical Index (MMI).”
  • The Wall Street Journal reports,
    • “National drugstore chains, once resistant to the retail apocalypse that swept across the U.S., are finally succumbing to competition from online shopping and discount stores.
    • “About 3,000 fewer drugstores were open for business at the start of this year compared with the same period in 2019, according to analytics company RetailStat, which tracks 15 pharmacy chains. 
    • “CVS Health, Walgreens and Rite Aid have each closed hundreds of stores since the onset of the pandemic. Online shopping has been growing and offers customers a more convenient way to buy household staples. 
    • “Competition has also increased from discount retailers such as Walmart, grocers such as Aldi, and dollar stores, which all sell many of the same items at lower prices. The spread of beauty stores such as Sephora further siphoned customers from drugstore aisles. 
    • “Everybody’s gone after a component of their business,” said Henry Fonvielle, president of the real-estate company Rappaport.”
  • STAT News notes that “Reports of telehealth’s death have been greatly exaggerated.”
    • “Virtual care isn’t in trouble. What is in trouble are the aftermarket telehealth solutions that largely function as a virtual extension of our siloed, fragmented health care system. This specific application of virtual care, which we call Telehealth 1.0, has consistently failed to bring meaningful value to patients, clinicians, and purchasers.
    • “In that sense, its collapse is a welcome development. It’s a sign that the market discerns where the real value lies in virtual care, and it validates the evolution from transactional, one-off care to more sophisticated virtual-first models.”
  • Per Healthcare Dive,
    • “UnitedHealth-owned Optum Rx, one of the biggest pharmacy benefit managers in the U.S., is launching a new drug pricing model next year meant to make payers’ spending on pharmaceuticals more predictable.
    • “The model, called Clear Trend Guarantee, combines costs that used to be separated out, including retail pharmacy, home delivery, specialty drug and rebates, into one single per-member price, according to a Monday release.
    • “Clear Trend is value-based, meaning Optum Rx will share in any savings tied to patient outcomes created in the model.”
  • Per Fierce Healthcare,
    • “The Purchaser Business Group on Health has unveiled a new purchasing agreement that aims to improve maternal health.”The Purchaser Business Group on Health has unveiled a new purchasing agreement that aims to improve maternal health.
    • “Benefits experts at retail giant Walmart and technology company Qualcomm led the initiative as co-chairs, with the goal of establishing “a collective commitment among employers and public purchasers of healthcare” to address maternal health and birth equity, according to an announcement from PBGH.
    • “The agreement centers on five key principles: deploying evidence-based, coordinated models to ensure high-quality care; ensuring timely access; promoting equitable care built on cultural humility; transparency and accountability; and value-based care.
    • “It also establishes a consensus for employers and public healthcare purchasers as to what high-quality and high-value maternity care is and outlines expectations for both insurers and providers to follow to meet that bar.”
  • Per BioPharma Dive,
    • “A decade ago, as British drugmaker AstraZeneca fought off a hostile takeover bid by Pfizer, CEO Pascal Soriot made a big promise: The company, he said, would boost sales by nearly three-quarters to reach $45 billion by 2023.”A decade ago, as British drugmaker AstraZeneca fought off a hostile takeover bid by Pfizer, CEO Pascal Soriot made a big promise: The company, he said, would boost sales by nearly three-quarters to reach $45 billion by 2023.
    • “With that goal now successfully met, Soriot on Tuesday announced a plan to push the company even higher, setting a target of $80 billion in annual sales by 2030. A slate of new medicines in metabolic and autoimmune disease headline the plan, which also involves sustaining existing businesses in respiratory disorders and cancer.
  • Beckers Hospital Review calls attention to “Fortune and PINC AI’s “15 Top Health Systems” list released May 21.”
  • McKinsey & Company discusses what’s new in consumer wellness trends.

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.

Monday Roundup

David Ermer–CDC, Congress, Medical / Rx research, Obesity, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Fierce Healthcare tells us
    • “A slew of bills targeting enhanced access to care within rural communities have, to the applause of the hospital industry, passed through committee to the full House of Representatives.
    • “The rural care bills that made it through the Ways and Means Committee’s Wednesday markup broadly support the financial stability of designated Critical Access Hospitals (CAHs) and Rural Emergency Hospitals (REH) along with other smaller hospitals serving rural communities [, among other objectives discussed in the article].
    • “These included The Preserving Emergency Access in Key Sites Act of 2024 (PEAKS Act), which expands increased emergency ambulance services coverage for patients served by CAHs; The Rural Hospital Stabilization Act, which authorizes new grants funding for investments into CAHs, REHs and small rural hospitals staving off potential closure; and The Second Chances for Rural Hospitals Acts, which expands the eligibility requirements for low-volume hospitals that wish to become REHs.”
  • Per an HHS press release,
    • “Today, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the winners of the FentAlert Challenge, which sought innovative ideas from U.S. youth, aged 14-18, to develop a community strategy to educate their peers about fentanyl and fake pills ― and prevent drug overdose deaths. The Challenge supports primary prevention efforts prioritized in the Department of Health and Human Services (HHS) Overdose Prevention Strategy, a key element of the Biden-Harris Administration’s Unity Agenda’s focus on beating the opioid crisis. The Challenge received almost 200 entries from across the country.
    • “The announcement launched National Prevention Week (NPW) (May 12-18), which celebrates the possibilities of prevention science and offers a platform to showcase substance use prevention activities across the country.”
  • Federal News Network lets us know,
    • “The nation’s top doctor is prescribing more attention to federal employees’ mental health and well-being.
    • But now in a hybrid work environment, that task has become remarkably more challenging, U.S. Surgeon General Vivek Murthy said.
    • “I do think that there are a lot of positives to having flexibility to be able to work from home — reduced commute times, time with family, being able to pick your kids up from school, be home for family dinner, while also not sacrificing your work,” Murthy said Thursday during a mental health and wellness event at the Office of Personnel Management. “But I think one of the things we also have to realize is that all of these choices come with trade-offs.”
    • “One of those trade-offs, he said, is that it can become harder to build social connections among coworkers — something that’s crucial for an agency’s operations overall.
    • “When people feel connected to other people in the workplace, that actually positively impacts their creativity, their productivity, and ultimately contributes to their engagement and retention,” Murthy said. “Creating opportunities for people to come back in person periodically, creating more intentional opportunities for people to be able to connect and learn about one another virtually, those become increasingly important when you’re in a hybrid work environment.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Do you know how old your heart is? And does it even matter? 
    • “More online calculators, wearable devices and medical tests are attempting to estimate your heart’s age. The companies and organizations behind the tools say that having insight into your heart health can prompt you to make lifestyle changes to help stave off cardiovascular disease down the road.
    • “It’s an extension of our newfound obsession with “biological age,” the concept that your body, or parts of it, can be physically aging faster or slower than your actual age. And that by knowing those ages, you can take control to live longer and healthier. 
    • “As for the heart, scientists say the tools can be a helpful jumping-off point for conversations with doctors about habit changes or medications before heart disease sets in. 
    • But you should take the results with a grain of salt, doctors and researchers say. The age calculations tend to be imprecise and don’t capture all of your possible risk factors, such as family history, air pollution, pregnancy complications or genetic variations. 
    • “It’s pretending to quantify something for you specifically that is just directionally true,” says Dr. Gregory Katz, a cardiologist at NYU Langone Heart. “It’s based on a true story, but it’s not actually a true story.”
  • Bloomberg Prognosis discusses “advances in treating brain cancer using different forms of immunotherapy — CAR-T, which uses engineered T-cells, and a messenger RNA-based therapeutic vaccine.”
  • Bloomberg also notes,
    • “Patients could wean themselves off blockbuster drugs such as Ozempic or Wegovy without piling the pounds back on, according to a scientific study.
    • “Data [from a small study] presented at the European Congress on Obesity in Venice, Italy on Sunday provides some of the first evidence that it could be possible to stop taking Novo Nordisk’s Ozempic or Wegovy and not regain any weight that has been lost — as long as a healthy lifestyle is maintained. * * *
    • “The Danish study of patients using semaglutide, which is the active ingredient in Ozempic and Wegovy, alongside a weight management program run through the Embla app, suggests that tapering the drug — instead of a hard stop — could potentially prevent weight regain. 
    • “However, just 353 patients were in the sample of patients who stopped semaglutide, which is a small study size. These patients had reached their target weight and reduced their semaglutide dose over nine weeks. Patients continued to lose weight as they tapered, losing an average of 2.1% over the nine weeks. * * *
    • “The combination of support in making lifestyle changes and tapering seems to allow patients to avoid regaining weight after coming off semaglutide,” said Henrik Gudbergsen, lead researcher and Embla’s chief medical officer, in a statement.”
  • STAT News informs us,
    • “Reluctance among dairy farmers to report H5N1 bird flu outbreaks within their herds or allow testing of their workers has made it difficult to keep up with the virus’s rapid spread, prompting federal public health officials to look to wastewater to help fill in the gaps.
    • “On Tuesday, the Centers for Disease Control and Prevention is expected to unveil a public dashboard tracking influenza A viruses in sewage that the agency has been collecting from 600 wastewater treatment sites around the country since last fall.
    • “The testing is not H5N1-specific; H5N1 belongs to the large influenza A family of viruses, as do two of the viruses that regularly sicken people during flu season. But flu viruses that cause human disease circulate at very low levels during the summer months. So the presence of high levels of influenza A in wastewater from now through the end of the summer could be a reliable indicator that something unusual is going on in a particular area.
    • “Wastewater monitoring, at least at this stage, cannot discern the sources — be they from dairy cattle, run-off from dairy processors, or human infections — of any viral genetic fragments found in sewage, although the agency is working on having more capability to do so in the future.”
  • The Washington Post offers Consumer Reports guidance on how to reduce your exposure to plastics in food (and elsewhere).

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Kaiser Permanente kicked off 2024 with $935 million of operating income (3.4% operating margin) and over $2.7 billion of net income when excluding a one-time, $4.6 billion net asset gain from its Geisinger Health acquisition, according to topline first-quarter numbers shared late Friday.
    • “The performance handily outpaces the $233 million operating income (0.9% operating margin) and $1.2 billion bottom line of last year’s opening quarter.
    • “Still, the integrated nonprofit noted that its operating income was still “below historical first-quarter trends leading up to the pandemic” due to industry-wide cost pressures around high utilization, care acuity and elevated goods and services expenses. The top of the year is typically bolstered by the timing of the open enrollment cycle, and then followed by steady revenue but rising expenses, the organization explained.”
  • RAND reports
    • “Prices paid to hospitals during 2022 by employers and private insurers for both inpatient and outpatient services averaged 254 percent of what Medicare would have paid, with wide variation in prices among states, according to a new RAND report.
    • “Some states (Arkansas, Iowa, Massachusetts, Michigan, Mississippi) had relative prices under 200 percent of Medicare, while other states (California, Florida, Georgia, New York, South Carolina, West Virginia, Wisconsin) had relative prices that were above 300 percent of Medicare.
    • “Even as the number of hospitals and insurance claims analyzed has grown across multiple rounds of the RAND Hospital Price Transparency Study the state-level average price has remained above 200 percent of Medicare—from 247 percent of Medicare prices in 2018 to 224 percent in 2020 and to 254 percent in 2022.”
  • Fierce Healthcare also points out
    • “Foley & Lardner released a new state survey of telehealth insurance laws that tracks the changes in the legal landscape from 2019, before the COVID-19 public health emergency, until April 2024.
    • “The survey includes key figures on each state’s telehealth commercial insurance coverage and payment/reimbursement laws.
    • “Nearly all states have adopted a telehealth statute as of April 2024. Of particular note is the number of states that expanded audio-only coverage, states that implemented coverage and payment parity for mental and behavioral health provided via telehealth, and states that passed reimbursement and parity laws.” 
  • Following up on Cybersecurity Saturday, Fierce Healthcare noted earlier today,
    • “Ascension said it is communicating with several government organizations and for the first time referred to its cybersecurity event as a “ransomware incident” in an update posted this weekend. 
    • “The 140-hospital health system said that it is still working to investigate and restore its systems—a process that is “making progress” but “will take time to complete” across each of its care sites. 
    • “In the meantime, the system said it has notified law enforcement and other government bodies including the FBI, the Cybersecurity and Infrastructure Security Agency (CISA) and the Department of Health and Human Services, among others.” 

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.

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.”

Thursday Miscellany

David Ermer–CMS, Congress, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Washington Post reports,
    • “Congressional leaders unveiled Thursday a $275 million bill to boost federal research, physician training and public awareness about menopause, a campaign led by prominent female lawmakers and boosted by the star power of actor Halle Berry.
    • “The bipartisan Senate bill, the Advancing Menopause Care and Mid-Life Women’s Health Act, is led by Sen. Patty Murray (D-Wash.), chair of the Senate Appropriations Committee, and has support from Sens. Lisa Murkowski (R-Alaska), Tammy Baldwin (D-Wis.), Susan Collins (R-Maine) and other lawmakers. The legislation has been championed by Berry, who has discussed her experience with menopause-related misdiagnoses and joined female senators at a news conference Thursday at the U.S. Capitol.”
  • The Wall Street Journal lets us know,
    • “Drunken-driving deaths in the U.S. have risen to levels not seen in nearly two decades, federal data show, a major setback to long-running road-safety efforts.
    • “At the same time, arrests for driving under the influence have plummeted, as police grapple with challenges like hiring woes and heightened concern around traffic stops. 
    • “We are really stuck in some quicksand,” said James Fell, who has been studying impaired driving since 1967 and is a principal research scientist at NORC at the University of Chicago, a nonpartisan research organization.
    • “About 13,500 people died in alcohol impairment-related crashes in 2022, according to data released in April by the National Highway Traffic Safety Administration. That is 33% above 2019’s toll and on par with 2021’s. The last time so many people died as a result of accidents involving intoxicated drivers was in 2006.”
  • The Society for Human Resource Management notes,
    • “Compensation growth kicked up more than expected in the first quarter of the year in another sign of persistent inflation.
    • “Workers were paid 1.2 percent more in the first three months of 2024 than in the fourth quarter of 2023, according to the Employment Cost Index (ECI), released April 30 by the U.S. Bureau of Labor Statistics (BLS). That’s up from the 0.9 percent climb in the fourth quarter of 2023. Wages and salaries increased 1.1 percent, as did benefits costs, from December 2023. Many economists forecasted that the ECI would rise 1 percent.
    • “Year over year, compensation costs—including pay and benefits— in the U.S. for civilian workers rose 4.2 percent, an uptick from the 4.1 percent year-over-year rise in the final quarter of 2023. Meanwhile, compensation for state and local government workers is up 4.8 percent.
    • “Wages and salaries grew 4.4 percent for the 12-month period ending in March 2024 and rose 5 percent for the 12-month period ending in March 2023, according to the BLS. Benefits costs grew 3.7 percent over the year and rose 4.5 percent for the 12-month period ending in March 2023.”

From the public health and medical research front,

  • NBC News reports,
    • “The number of women dying while pregnant is returning to pre-pandemic levels following a worrisome 2021 spike, a new report from the Centers for Disease Control and Prevention shows.
    • “In 2022, 817 U.S. women died either while pregnant or soon after giving birth, down from 1,205 the previous year.
    • “If you look at 2021, we had such a sharp increase as we were really still in the pandemic and still dealing with disruptions of care, the fear of coming into the healthcare space and the inability to access care during that time,” said Dr. Veronica Gillispie-Bell, an OB-GYN at Ochsner Medical Center in Kenner, Louisiana. She was not involved in the new report, which was published Thursday by the CDC’s National Center for Health Statistics.”
  • mHealth Intelligence tells us,
    • “Telehealth-based interventions can help lower the risk of readmissions and emergency department (ED) visits after abdominal surgery, according to new research published in JAMA Network Open.
    • “The study notes that amid the digital healthcare boom of the COVID-19 pandemic, telehealth technologies were applied in areas where they were previously not used, including surgery. Though the use of telehealth in surgery is growing, the study authors noted that there is little research on how telehealth utilization affects patient safety in abdominal surgery.
    • “Thus, the researchers conducted a systematic review and meta-analysis to evaluate whether telehealth-based interventions reduce complications, readmissions, and postoperative ED visits among abdominal surgery patients. They searched PubMed, Cochrane Library, and Web of Science databases from inception through February 2023 to identify randomized clinical trials (RCTs) and nonrandomized studies that compared perioperative telehealth interventions with usual care and reported at least one patient safety outcome.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “Cigna has written off more than half of its multibillion-dollar investment in VillageMD amid the declining value of the primary care chain.
    • “Cigna invested $2.5 billion into VillageMD in late 2022, with the goal of accelerating value-based care arrangements for employer clients by tying VillageMD’s physician network with Cigna’s health services business, Evernorth — hopefully reaping profits from shared savings as a result.
    • “But on Thursday, Cigna wrote off $1.8 billion of that investment, citing VillageMD’s lackluster growth after its majority owner Walgreens elected to close underperforming clinics. The writedown drove Cigna’s shareholder earnings down to a net loss of almost $300 million, compared to profit of $1.3 billion in the same time last year.”
  • Per BioPharma Dive,
    • “Sales of Novo Nordisk’s obesity drug Wegovy slowed over the first three months of 2024, compared to the fourth quarter last year, as lower realized prices and continued supply constraints curbed growth from the in-demand medicine.”Sales of Novo Nordisk’s obesity drug Wegovy slowed over the first three months of 2024, compared to the fourth quarter last year, as lower realized prices and continued supply constraints curbed growth from the in-demand medicine.
    • “Still, the $1.3 billion in first quarter sales Novo reported for Wegovy was twice the total in the first quarter of 2023. The company has been working to boost supply and, in January, gradually started increasing the number of Wegovy “starter” doses.
    • “Wegovy gained competition last November with the U.S. approval of Eli Lilly’s Zepbound, which brought in $517 million in sales in its first quarter on the market. Citing data from analytics company Iqvia, Novo said that, while new prescriptions of Zepbound are tracking slightly ahead of Wegovy, its drug has larger market share.”
  • and
    • “Pfizer’s rare disease drug Vyndaqel may be its least well known blockbuster medicine. The pharmaceutical company’s COVID-19 vaccine became a household name during the pandemic, while its other top-sellers for blood clots, breast cancer and pneumococcal infections are routinely and widely advertised on TV.
    • “Yet during the first quarter, it was Vyndaqel that outperformed expectations, delivering sales that substantially exceeded Wall Street forecasts. The drug, which treats the cardiac form of a rare disease called transthyretin amyloidosis, brought in $1.1 billion between January and March, 25% higher than the consensus estimate of just over $900 million.”
  • MedCity News considers whether “Walmart’s decision to shutter its healthcare division reflects just how difficult it is to achieve profitability in the primary care and telehealth markets. Experts think retailers simply aren’t prepared to handle the bevy of challenges that come along with delivering healthcare — but could this news also be a sign of the system being broken?”
  • Bloomberg tells us,
    • “Amid the GLP-1 craze, companies including Quest Diagnostics and Labcorp are offering a suite of blood tests intended to help doctors decide if drugs like Wegovy and Zepbound are the right choice for their patients. So far, business is booming.”

Thursday Miscellany

David Ermer–CDC, COVID-19, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “American women are giving birth at record-low rates. 
    • “The total fertility rate fell to 1.62 births per woman in 2023, a 2% decline from a year earlier, federal data released Thursday showed. It is the lowest rate recorded since the government began tracking it in the 1930s. * * *
    • “Total fertility estimates the number of children a woman would give birth to in her lifetime. The estimates don’t account for what women actually decide in later years, said Brady Hamilton, a co-author of the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
    • “The number of births last year was the lowest since 1979, according to provisional data. About 3.59 million children were born in the U.S. in 2023, a 2% drop compared with 3.66 million in 2022. 
    • “The figures are provisional and likely to adjust slightly when final data are released later this year.”
  • The Congressional Budget Office shared a new presentation that “provides a brief summary of CBO’s long-term projections of federal health care spending, the distribution of federal subsidies for health care, the drivers of cost growth in health care, and options for reducing federal spending on health care.”
  • The Internal Revenue Service released a fact sheet that “provides answers to frequently asked questions (FAQs) addressing the tax treatment of work-life referral services (sometimes also called caregiver or caretaker navigation services) provided by an employer to an employee. Under certain circumstances, the value of such referral services can be excluded from gross income and employment taxes as a de minimis fringe benefit.”

From the public health and medical research front,

  • The AP reports,
    • “It’s easier than ever for doctors to prescribe a key medicine for opioid addiction since the U.S. government lifted an obstacle last year. But despite the looser restrictions and the ongoing overdose crisis, a new study finds little change in the number of people taking the medication.
    • “Researchers analyzed prescriptions filled by U.S. pharmacies for the treatment drug buprenorphine. The number of prescribers rose last year after doctors no longer needed to get a special waiver to prescribe the drug, while the number of patients filling prescriptions barely budged.
    • “Buprenorphine, which helps with cravings, comes in a pill or film that dissolves under the tongue. It costs about $100 a month. A common version of buprenorphine is Suboxone. Nurse practitioners, physician assistants and doctors can prescribe it.
    • “People think this is a very complicated medicine and that it requires some sort of complex knowledge to use, when that’s just not the case,” said Dr. Ryan Marino of Case Western Reserve University School of Medicine in Cleveland who has treated hundreds of people with buprenorphine. He had no role in the study.”
  • MedPage Today lets us know,
    • “Taste dysfunction was gone 1 year after exposure to COVID-19, but smell loss remained for some people, a national cross-sectional study showed.
    • “Empirically measured taste function didn’t differ between individuals who had acute SARS-CoV-2 infection a year earlier and uninfected people, reported Shima Moein, MD, PhD, of Sensonics International in New Jersey and the University of Pennsylvania in Philadelphia, and co-authors.
    • “However, olfactory dysfunction was present in 30.3% of individuals with prior COVID-19 compared with 21% of those who had no history of COVID infection (OR 1.64, 95% CI 1.18-2.27), Moein and colleagues noted in JAMA Network Open.
    • “Long-term taste loss after COVID may reflect damage to olfactory epithelium, not taste buds, the researchers suggested. Olfactory deficits were greatest for those diagnosed with COVID when the original untyped and Alpha viral variants were prevalent.
    • “Our study sheds light on a critical yet often overlooked aspect of the COVID-19 pandemic: the pervasive impact of smell loss on affected individuals,” Moein told MedPage Today. “Despite its prevalence, smell loss has remained largely neglected by healthcare professionals and policymakers, leading to a lack of awareness and support for affected individuals.”
  • and
    • “A majority of pregnant individuals or those trying to become pregnant were interested in getting a maternal respiratory syncytial virus (RSV) vaccine once it became available, a nationwide survey found.
    • “Of 1,528 respondents, 54% said they were “very likely” to get an RSV vaccine during pregnancy, Jennifer Saper, MD, of the Ann & Robert H. Lurie Children’s Hospital in Chicago, and colleagues reported in Pediatrics.
    • “I am excited by the findings that over half of pregnant, or trying-to-be-pregnant people are interested in the RSV vaccine in pregnancy,” Saper told MedPage Today in an email. “This means to me that there are a lot of opportunities to try to protect infants against RSV.”
  • The Dana Farber Cancer Institute shares five things to know about advances in the treatment of multiple myeloma.

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Bristol Myers Squibb will cut 6% of its workforce in a restructuring meant to save $1.5 billion in costs by the end of next year. 
    • “The layoffs will affect some 2,200 employees, the company said Thursday. It’s also trimming its pipeline of experimental medicines, consolidating its array of offices and laboratories and reducing “third party” spending.
    • “Our focus remains on strengthening the company’s long-term growth profile,” said company CEO Christopher Boerner, in a statement on the restructuring, which was announced alongside earnings for the first quarter.” 
  • and
    • “AstraZeneca’s revenue and profits grew at a rapid clip over the first three months of the year, beating Wall Street expectations as use of the British drugmaker’s flagship cancer drugs widened. 
    • “Total company revenue climbed 17% to $12.7 billion and operating profit jumped 22% to $3.1 billion, compared to the first quarter last year, the company said.
    • “Both the revenue and profit figures surpassed consensus forecasts by 7%, according to a note from Leerink Partners analyst Andrew Berens. The strong earnings were a recovery from the fourth quarter, when lower-than-expected sales and higher costs meant AstraZeneca missed profit estimates.”
  • Per Fierce Healthcare,
    • “Evernorth’s Accredo arm will make a Humira biosimilar available to patients with no out-of-pocket costs, the company announced Thursday.
    • “Accredo is the specialty pharmacy segment within Evernorth Health Services, which also houses Express Scripts, eviCore data analytics and MDLIVE telehealth services. [Cigna owns Evernorth.] Beginning this June, the low- and high-concentration biosimilar will be produced for Evernorth’s private label distributor, Quallent Pharmaceuticals, in partnership with multiple manufacturers. * * *
    • “Most patients will be able to secure the biosimilar products for $0 out-of-pocket through the copay assistance programs offered at Quallent beginning in June, Evernorth said.”
  • and
    • “Walgreens is expanding its specialty pharmacy services to offer gene and cell therapy services, supported by a dedicated 18,000-square-foot center in Pittsburgh, the company announced Thursday.
    • “The service is part of the retail pharmacy company’s newly integrated business unit, Walgreens Specialty Pharmacy, that rolls up all its specialty pharmacy segment assets, including AllianceRx. The new business, formerly called AllianceRx Walgreens Pharmacy, is under the Walgreens U.S. retail pharmacy segment.
    • “Walgreens said its integrated model enables it to work with payers, health plans and pharma with a specialty pharmacy offering independent of pharmacy benefit managers (PBMs).”
  • Beckers Health IT informs us,
    • “UnitedHealth Group’s Optum Virtual Care is shutting down, Endpoints News reported April 24.
    • “News of the closure of the company’s telehealth business came shortly after Optum employees took to social media beginning April 18 regarding a reduction in force they say occurred across the organization.
    • “Virtual care has been and will continue to be a core part of our comprehensive, integrated care delivery model designed to provide care to people where, when and how they prefer,” an Optum spokesperson told Becker’s. “We continually review the capabilities and services we offer to meet the growing and evolving needs of our businesses and the people we serve. As always, we will support affected team members with job placement resources and seek to deploy them where possible to any open roles within the company.”

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Federal News Network lets us know,
    • “Enrollees in the Federal Employees Health Benefits (FEHB) program just began seeing better coverage of in-vitro fertilization (IVF) for the first time this year. But some members of Congress are looking to take things a step further.
    • “More than 175 House and Senate Democrats are urging the Office of Personnel Management to require every FEHB carrier to expand their offerings and cover costs for both infertility treatments and medications, starting in plan year 2025.
    • “That requirement “would reflect the reality that IVF is one of the most effective treatments for families struggling with infertility, and growing in popularity, with its usage nearly doubling from 2012 to 2021,” the lawmakers, led by Rep. Gerry Connolly (D-Va.) and Sen Tammy Duckworth (D-Ill.), wrote in a letter to OPM Tuesday.”
  • The Congressional letter does not reflect the fact that at least one option of many large FEHB plans do cover IVF treatments and likely more plans will offer that coverage for 2025 due to competition because growing families are good FEHB customers.
  • The Department of Health and Human Services released the 2024 National Strategy for Suicide Prevention (National Strategy) and accompanying Federal Action Plan. * * * To learn more about the 2024 National Strategy for Suicide Prevention and Federal Action Plan, visit www.hhs.gov/nssp.”
  • The Food and Drug Administration announced,
    • “a new initiative aimed to help reimagine the home environment as an integral part of the health care system. The Home as a Health Care Hub is intended to enable solutions that seamlessly integrate medical devices and health care, prevention and wellness into people’s lives and may: 
      • “Help medical device developers consider novel design approaches. 
      • “Aid providers to consider opportunities to extend care options and educate patients.
      • “Generate discussions on value-based care paradigms.
      • “Open opportunities to bring clinical trials and other evidence generation processes to underrepresented communities.”
  • The American Hospital Association News tells us,
    • “The Federal Trade Commission April 23 voted 3-2 to issue a final rule that would ban as an unfair method of competition contractual terms that prohibit workers from pursuing certain employment after their contract with an employer ends. The final rule does not apply to existing agreements with executives earning more than $151,164 annually who are in policymaking positions. In addition, although the Commission recognized that it does not have jurisdiction over not-for-profit entities, it reserved the right to evaluate an entity’s non-profit status and noted that some “entities that claim tax-exempt nonprofit status may in fact fall under the Commission’s jurisdiction.” Specifically, it stated that “some portion of the 58% of hospitals that claim tax-exempt status as nonprofits and the 19% of hospitals that are identified as State or local government hospitals in the data cited by AHA likely fall under the Commission’s jurisdiction and the final rule’s purview.”
    • “The rule takes effect 120 days after publication in the Federal Register and includes model language that employers can use to communicate to workers.  The United States Chamber of Commerce has already indicated that it will file suit to challenge the final rule.”
  • Healthcare Dive adds
  • HR Dive notes,
    • “The U.S. Department of Labor said Tuesday it will publish a final rule raising the Fair Labor Standards Act’s minimum annual salary threshold for overtime pay eligibility in a two-step process. Starting July 1, the threshold will increase from $35,568 to $43,888 per year. It will then increase to $58,656 on Jan. 1, 2025.
    • “The changes will expand overtime pay eligibility to millions of U.S. workers, the agency said. DOL’s 2025 threshold represents a jump of about 65% from the Trump administration’s 2019 rule and is slightly higher than the $55,068 mark that DOL proposed in 2023.
    • “The threshold will automatically update every three years using current wage data — which would next occur on July 1, 2027 —  but DOL said in the proposed rule that updates may be temporarily delayed if the department chooses to engage in rulemaking to change its methodology or update mechanism.”
  • Per FedWeek,
    • “The inspector general’s office at OPM has posted a warning against calling a phone number once associated with the agency’s Employee Express FEHB enrollment site (888-353-9450), saying the number “is currently in use by fraudsters/bad actors who have practiced financial exploitation tactics.”
    • “This phone number was provided on U.S. Department of State human resources notices to employees and Foreign Service retirees. It may also be or have been provided on other participating federal agencies’ human resources or information. This customer service phone number is no longer in use by OPM or the federal government,” it says.”

From the public health and medical research front,

  • The Wall Street Journal reports, “Removing ovaries with a hysterectomy might increase risk of heart disease, stroke and dementia.”
    • “A removal of the ovaries before menopause and before age 46 years may cause an acceleration of the aging processes across many organs, for example, the brain, and many tissues of the body, for example, the bones,” says Dr. Walter Rocca, who is a professor of epidemiology and neurology at the Mayo Clinic in Rochester, Minn., and has written studies on the topic. * * *
    • “Rocca was co-author of a 2021 Jama Network Open study that found that women under 46 who removed both of their ovaries with or without a hysterectomy had an increased risk of mild cognitive impairment and performed worse on cognitive tests 30 years later compared with women who didn’t undergo the procedure.
    • “Another study Rocca co-wrote found that women who had ovaries removed before age 50 faced higher risks for several conditions years later, including heart disease and osteoporosis.
    • Other studies have linked the procedures to an increased risk of dementia, Parkinson’s disease and accelerated aging.
    • “Sometimes, patients push to have their ovaries out at a younger age to help with symptoms such as pelvic pain or to avoid a subsequent surgery, says Dr. Daniel Breitkopf, chair of OB-GYN at Mayo Clinic and a member of ACOG’s board of directors. He usually advises waiting.
    • “I would rather do an oophorectomy five or 10 years later so then we have five to 10 years of benefit of those ovaries on your health,” he says.” 
  • The Washington Post informs us,
    • “Viral fragments of bird flu have been identified in samples of milk taken from grocery store shelves in the United States, a finding that does not necessarily suggest a threat to human health but indicates the avian flu virus is more widespread among dairy herds than previously thought, according to two public health officials and a public health expert who was briefed on the issue.
    • “The Food and Drug Administration said Tuesday that it had been testing milk samples throughout the dairy production process and confirmed the detection of viral particles “in some of the samples,” but it declined to provide details.
    • “The presence of genetic fragments of the virus in milk is not unexpected. Pasteurization typically works to inactivate pathogens, said Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health. It generally does not remove genetic material, Nuzzo said, but typically renders pathogens unable to cause harm to people.”
    • “The greater concern, however, “is that it’s showing up in a lot more samples, meaning the infection is more widespread in dairy herds than we thought,” said one public health official, who spoke on the condition of anonymity to share information not yet made public.”
  • STAT News tells us,
    • “Day One Biopharmaceuticals said Tuesday the Food and Drug Administration gave accelerated approval to its targeted pill for one of the most common forms of childhood brain tumors, pediatric low-grade glioma.
    • “The weekly pill, previously known as tovorafenib, will be marketed as Ojemda. These tumors generally regress when patients become adults, but toxic treatments are often needed to keep them at bay until then. The hope is that Ojemda can spare some children from, for example, radiation, which can devastate tumors but also healthy tissue throughout the brain and bring lifelong consequences.  * * *
    • “Day One plans to release a price Wednesday morning. 
    • “The authorization is particularly notable because industry has historically developed few drugs for children with cancer, instead focusing on adults, where there is a larger market.” 
  • Per BioPharma Dive,
    • “Neurocrine Biosciences, a drugmaker focused on the brain and nervous system, said Tuesday that one of its experimental medicines succeeded in a clinical trial evaluating it as a treatment for major depression.
    • “The medicine hit the Phase 2 trial’s main goal as well as “key secondary endpoints,” according to Neurocrine, which plans to meet with the Food and Drug Administration to discuss a path to late-stage testing. If positive results continue to pile up, the medicine could become the first of its kind to secure an approval.
    • “Eiry Roberts, Neurocrine’s chief medical officer, called the newly released data “very encouraging” and reflective of the medicine’s potential to alleviate many of the symptoms associated with major depressive disorder.”
  • HealthDay relates,
    • “The dangerous heart rhythm disorder called atrial fibrillation is becoming more common in middle-aged people, a new study warns.
    • “More than a quarter of patients at the University of Pittsburgh Medical Center (UPMC) seeking care for A-Fib during the last decade were younger than 65, researchers found.
    • “That’s much higher than the 2% prevalence of A-Fib commonly estimated among non-seniors, researchers said.
    • “Common knowledge among cardiologists is that, in people under 65, A-Fib is extremely uncommon and not detrimental. But there really hasn’t been any data to back that up,” said lead researcher Dr. Aditya Bhonsale, a UPMC cardiac electrophysiologist.
    • “The study also found that younger patients with A-Fib were more likely to die or to be hospitalized for heart failure, stroke or heart attack.”
  • Medscape discusses four recently FDA approved therapies that “are likely to be particularly important for primary care clinicians.” 

From the U.S. healthcare business front,

  • Health Payer Intelligence reports,
    • “Provider markups on specialty drugs increased 2024 commercial health insurance premiums by $13.1 billion, according to research from Oliver Wyman commissioned by AHIP.
    • “Provider-administered drugs can be delivered directly to providers from a specialty pharmacy—known as white bagging—or providers can purchase the drugs from the manufacturer or distributor and store the drug until the patient needs it, also called buy and bill.
    • “In the buy-and-bill method, hospitals and physicians can add a markup to the drug, which patients are responsible for paying. Delivering drugs through white bagging is generally more affordable for patients and payers because pharmacies do not add markup charges.
  • mHealth Intelligence relates, “Though telehealth utilization resulted in improvements in some healthcare utilization and quality measures, it was also linked to a 1.6 percent increase in healthcare spending, according to new research published in Health Affairs.”
  • STAT News adds,
    • “In the early days of the pandemic, as social distancing forced patients out of doctors’ offices, health care organizations scrambled to offer care online. In turn, health care accreditation organizations rushed to tweak their standards, filling a void in best practices for virtual visits.
    • “But as telehealth has matured, accreditation bodies — typically nonprofits that offer a seal of approval to organizations that pass their audits — are trying to address the nuance of digital care head-on. Today, the Joint Commission announced a new telehealth accreditation that will launch on July 1. Later that month, the National Committee for Quality Assurance plans to release its own virtual care standards, with applications for a new accreditation opening in November.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • ICER and NEWDIGS at Tufts Medical Center “have collaborated to publish a new white paper today that provides clear policy and market solutions to help manage the challenges of paying for gene therapies. The paper, entitled, “Managing the Challenges of Paying for Gene Therapy: Strategies for Market Action and Policy Reform,” was developed with input from a diverse set of patient advocacy groups, payer organizations, large and small biopharmaceutical manufacturers, providers, and others.”
    • “The specific policy reforms and market-based tools ICER and NEWDIGS identify in the paper are intended to help the US health system address these challenges to achieve more equitable and affordable access for patients to the growing number of gene therapies expected to be approved in the coming years. Options such as value-based pricing, value-based outcomes contracts, warranties, subscription insurance models, installment payment arrangements, and a federal carve-out benefit program are explored. For each option, the white paper analyzes the relative advantages and potential unintended consequences, along with suggestions for implementation, and an exploration of unique opportunities for combination or layered approaches.
    • “Gene therapies have the possibility to transform thousands of lives, but only if we ensure sustainable access to them for all patients,” said Sarah K. Emond, MPP, President and CEO of ICER. “It is incumbent upon the entire health care system to focus on innovative payment solutions that can address the challenges of paying for high-cost, one-time treatments. This paper should help stakeholders understand the menu of options available to move beyond responding to the high costs with reduced access, while meaningfully addressing the concerns around clinical uncertainty and budget impact.”
    • “Each condition, therapy and payer is unique, so a single solution cannot satisfy all situations,” said Mark Trusheim, Strategic Director of NEWDIGS. “With a menu of options which can be combined in a single contract or assembled from existing market offerings, each community can construct the most effective approach to ensuring appropriate patient access in their area.”
  • Reuters reports,
    • “Eli Lilly (LLY.N), said on Monday that it will acquire a manufacturing facility from Nexus Pharmaceuticals to produce injectable medicines.
    • “Lilly expects production at the facility based in Pleasant Prairie, Wisconsin, to begin at the end of 2025.”
    • “Soaring demand for GLP-1 agonists, a class of highly effective diabetes and obesity drugs which suppress appetite and promote a feeling of fullness, has led to constrained supply for drugmakers such as Lilly and Danish drugmaker Novo Nordisk.”
  • Beckers Payer Issues lets us know,
    • “A merger between Humana and Cigna could still be in the cards according to one analyst, Bloomberg reported April 22. 
    • “The math now works for a [Cigna and Humana] fusion,” Jeffries analyst David Windley wrote April 22. Since the two companies abandoned a proposed merger in December, Cigna’s stock prices have risen by 37% and Humana is down 31%, according to Bloomberg. 
    • “Cigna could strike a deal to acquire Humana for around $420 per share, Mr. Windley wrote in a note to clients. An acquisition would add to Cigna’s growth if it does not pay more than $470 per share for the company, according to Jeffries.” 
  • Per Fierce Healthcare,
    • “About a week ago, cybersecurity experts identified posts from the criminal group RansomHub that suggested the data from the Change Healthcare hack was up for sale.
    • “Those listings have since been pulled, according to a twitter post from Brett Callow, a threat analyst at Emsisoft. It’s unclear at present what led the group to suspend the sale, as they were seeking an additional ransomware payout from Change’s parent company UnitedHealth Group.”

Thursday Miscellany

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

From Washington, DC

  • This morning, the Senate Finance Committee held a hearing to “discuss how to update and strengthen Medicare’s guarantee of high-quality health benefits for the next generation of America’s seniors.”
  • Healthcare Dive informs us,
    • “Lawmakers lauded the benefits of telehealth during a hearing Wednesday, but House members also raised questions about cost, quality and access that still need to be answered as a year-end deadline looms.
    • “As a December deadline draws closer, legislators are working to hash out details about extending or making pandemic-era telehealth flexibilities in Medicare permanent. 
    • “During an hours-long House Energy and Commerce subcommittee hearing, lawmakers considered 15 different legislative proposals surrounding telehelath access, noting changes in Medicare will impact decisions of private insurers.
    • “There’s an urgent need to extend these flexibilities because it’s going to run out,” said Rep. Anna Eshoo, D-Calif. “We need to take action on this.” 
  • STAT News adds,
    • “More than a quarter of outpatient antibiotics are inappropriately prescribed, and telehealth could exacerbate the problem: Studies have suggested that virtual visits, on average, result in more antibiotic prescribing than in-person visits. But not all telehealth is created equal — and research is beginning to untangle which approaches are more likely to result in unnecessary antibiotics. In turn, national telehealth guidelines and standards are fighting back by prioritizing safe and effective virtual prescribing practices.
    • “It’s hard to draw conclusions about antibiotic prescribing via telehealth because it comes in so many flavors, said Guillermo Sanchez, a physician assistant and epidemiologist with the office of antibiotic stewardship at the Centers for Disease Control and Prevention. Telemedicine can be provided by direct-to-consumer companies in one-off visits or by large, integrated health systems; via message, phone, or video.
    • “In a recent literature review, Sanchez and his colleagues found studies showing antibiotics were prescribed similarly in virtual and in-person appointments, as well as research that showed higher prescribing in virtual visits — especially for upper respiratory infections that rarely need antibiotics.
    • “But one thing is clear: There’s plenty of room for improvement.”
  • American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention April 11 updated its strategy to improve data exchange with health care organizations and other public health authorities to better detect and monitor public health threats. Among other priorities for 2024-2025, the strategy calls for using the Office of the National Coordinator for Health Information Technology’s Trusted Exchange Framework and Common Agreement to enable faster sharing of data between health care and public health; expanding core data sources to detect and monitor threats, including wastewater, hospitalization and hospital bed capacity; and prioritizing data to address health disparities and promote health equity.”
  • STAT News reports,
    • “Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer has projected — according to a document obtained by STAT.
    • “Medicare’s actuaries expect the drug Leqembi, made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medicare program $3.5 billion in 2025, a spokesperson for the Centers for Medicare and Medicaid Services confirmed to STAT. That projection forecasts a large increase in uptake over the next year and a half.
    • “The estimate was buried in a new CMS document that addressed questions about next year’s payments for Medicare Advantage plans, which cover more than 33 million people and serve as the alternative to the traditional Medicare program.
    • “I think CMS’ estimates demonstrate an incredible demand for Alzheimer’s treatments and possibly suggest broader use than I think was originally conceived,” said Ameet Sarpatwari, an assistant professor of medicine at Harvard Medical School who studies pharmaceutical costs and outcomes. “That raises the question: What are we, as taxpayers, willing to spend on this drug with limited resources?”
  • The U.S. Office of Personnel Management announced,
    • “The U.S. Office of Personnel Management (OPM) issued a final rule today on the Pathways Programs designed to significantly expand opportunities for early career talent in the federal government. The final rule is one of the most significant actions the federal government has taken since the program’s inception 14 years ago. Updates include expanding skills-based hiring through qualifying career programs, raising the ceiling for starting salaries for recent graduates, and easing the path for interns to be converted into permanent positions, including lowering the number of hours required to convert and expanding the time given to agencies to complete such a conversion.  
    • “In addition, OPM will soon release new web-based guidance, an updated Pathways Program Handbook, an updated Pathways Toolkit for federal managers and supervisors, and will host a series of webinars and office hours targeted at HR professionals, hiring managers, educational institutions, and other key stakeholders.”  

From the public health and medical research front,

  • MedPage Today tells us,
    • “The hunt for a signal of excess sudden cardiac deaths among young people after COVID-19 vaccination left Oregon health officials empty-handed, they reported.
    • “Investigators searched death certificates for Oregon residents 16-30 years old who died from cardiac or undetermined causes of death from June 2021 to December 2022 and tried to match these deaths with mandatory statewide records of mRNA COVID vaccination, according to Juventila Liko, MD, and Paul Cieslak, MD, both of the Oregon Health Authority’s Public Health Division in Portland, in the CDC’s Morbidity and Mortality Weekly Report.”
  • The NIH Director in her blog lets us know,
    • “Colorectal cancer is a leading cause of death from cancer in the United States. We know that risk of colorectal cancer goes up with age, certain coexisting health conditions, family history, smoking, alcohol use, and other factors. Researchers are also trying to learn more about what leads colorectal cancer to grow and spread. Now, findings from a new study supported in part by NIH add to evidence that colorectal tumor growth may be driven by a surprising bad actor: a microbe that’s normally found in the mouth.
    • :The findings, reported in Nature, suggest that a subtype of the bacterium Fusobacterium nucleatum has distinct genetic properties that may allow it to withstand acidic conditions in the stomach, infect colorectal tumors, and potentially drive their growth, which may lead to poorer patient outcomes. The discoveries suggest that the microbe could eventually be used as a target for detecting and treating colorectal cancer.”
  • Beckers Hospital Review points out,
    • “The number of ongoing drug shortages in the U.S. is at its highest since 2001 — when the American Society of Health-System Pharmacists began tracking data. There are now 323 medications in low supply. 
    • “The reasons for 3 in 5 shortages are unknown, the ASHP said in a report released April 11. Supply and demand are cited for 14% of shortages, manufacturing problems for 12%, business decisions for 12% and raw material issues for 2%. 
    • “Basic and life-saving products are in short supply, including oxytocin, Rho(D) immune globulin, standard of care chemotherapy, pain and sedation medications and ADHD [attention-deficit/hyperactivity disorder] medications,” the ASHP said. 
    • “The top five drug classes in shortages are central nervous system agents, antimicrobials, hormone agents, chemotherapies, and fluid and electrolyte therapies.” 
  • Mercer Consulting alerts us,
    • “Are you ready for the 75-year plus workforce? That’s the question Dr. Charlotte Yeh from AARP Services Inc. asked our webcast participants when she sat down with Mercer’s Kate Brown to discuss how longevity is changing workforce demographics.
    • “In the last 100 years, the 65+ age group has grown five times faster than the rest of the population. What’s even more surprising are projections that people aged 75+ will constitute the fastest-growing age band in the civilian workforce between now and 2030! As an employer, are you prepared for these changing demographics?
    • “In this conversation, Dr. Yeh debunks common myths about older workers – including their inability to use technology to perform essential job functions. In fact, studies show that age-diverse workforces contribute to increased revenue and profit margins – perhaps not surprising given that people 50 and older, contribute $8.3 trillion dollars to the economy. At the same time, working later in life can provide seniors with purpose and social connections, both essential to health and happiness.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Hospitals and health systems have kicked off the calendar year with a flurry of merger and acquisition deals reflecting several different strategic trends driving providers in 2024.
    • “Twenty transactions were unveiled in the first quarter, marking the highest volume of dealmaking Kaufman Hall’s seen within the sector since 2020, according to a report from the healthcare consulting firm released Thursday.
    • “The deals involved organizations of varying sizes and types, the firm wrote, and appeared motivated by a combination of new and old health system trends — for instance, smaller community systems flocking to larger organizations with stable finances, or portfolio realignments among for-profit and non-profit systems alike.”
  • According to Beckers Hospital Review,
    • “Less than 20% of the nation’s hospitals were recognized for excellent patient safety ratings and the highest level of adherence to federal price transparency rules. 
    • “On April 9, the Health Transformation Alliance, The Leapfrog Group and Turquoise Health honored 472 hospitals across 42 states. Each of the organizations received a Leapfrog “A” safety rating and the highest price transparency score from Turquoise Health. 
    • “We encourage all hospitals to look to these industry leaders in both patient safety and price transparency as a model for how to provide patient-centered, high-quality care,” Robert Andrews, CEO of Health Transformation Alliance, said in a news release. “In following their example and commitment to safety and price transparency, we believe the healthcare industry can collectively strive towards better health outcomes for all.”

From the legal news front,

  • Biopharma Dive reports,
    • “The U.S. Department of Justice on Wednesday accused Regeneron of defrauding Medicare by knowingly inflating the average sales price for its top-selling eye drug Eylea.
    • “In a lawsuit filed in U.S. District Court in Massachusetts, prosecutors alleged Regeneron failed to disclose hundreds of millions of dollars in price concessions given to drug distributors in the form of credit card fee reimbursements. As a result, they said, the average sales price for Eylea, which Medicare uses to set payment to doctors, was higher than it should have been.
    • “Regeneron’s tactics also gave it an unfair competitive advantage over rivals, the Justice Department said. Eye clinics were able to get Regeneron’s drug for the discounted cash price while at the same time reaping the benefits of credit card rewards such as “cash back.” At some practices, doctors took turns using their personal credit cards to buy the drug, the lawsuit said. * * *
    • “In a statement to BioPharma Dive, Regeneron said it believes the allegations are “without merit” and show a “fundamental misunderstanding of drug price reporting standards.” The company added that it will defend itself in court.” 
  • The U.S. Attorney for the Southern District of Florida announced,
    • “On April 10, a substance abuse facility owner was sentenced to four years in federal prison, followed by three years of supervised release, and ordered to pay $4,444,417.65 in restitution, for defrauding the Federal Employees Health Benefits Program (FEHBP) of over $4 million. The sentence comes after the defendant entered a guilty plea in February.
    • “Joseph Toro, 39, of Jupiter, Florida, owned and operated Reawakenings Wellness Center (RWC), a substance abuse facility that treated patients, including FEHBP beneficiaries, from 2013 until January 2018, when RWC was evicted from their location in Miramar, Florida. After the RWC eviction, Toro continued to submit FEHBP insurance claims, using personal identifying information of former RWC patients, for substance abuse treatment that was never provided. To do so, he called the FEHBP hotline, impersonated former patients, and changed their mailing addresses to addresses that he controlled so he could obtain the fraudulent insurance reimbursement checks. For over a year, Toro submitted fraudulent claims on behalf of 29 former RWC patients for over $6.7 million in substance abuse treatment that he knew RWC never provided. As a result of Toro’s fraudulent claims, he obtained nearly $4.2 million in proceeds from the FEHBP. Toro also applied for and obtained a $150,000 Economic Injury Disaster Loan (EIDL) from the U.S. Small Business Administration (SBA) during the COVID-19 pandemic. That application misrepresented that RWC had five employees and grossed over $1.4 million in 2019, when in truth RWC had shut down years prior.”