Thursday Miscellany

Obesity

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • OPM’s proposed supplemental Postal Service Health Benefits Program rule was posted on the Federal Register’s public inspection list today. The proposed rule will be published in the Federal Register tomorrow and the comment deadline will be thirty days thereafter.
  • The American Hospital News informs us,
    • “The Senate Committee on Health, Education, Labor and Pensions May 23 passed legislation that included proposals on mental health and emergency pediatric services during a markup session. The AHA submitted a statement for the hearing, expressing support for the passage of the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act (S. 3679), which would reauthorize grants for health care providers to establish programs offering behavioral health services for front-line workers, as well as a national education and awareness campaign providing health leaders with evidence-based solutions to reduce health care worker burnout. The AHA also expressed support for the bill as a member of the Healthcare Workforce Coalition, which earlier this week sent a letter to Senate HELP Committee leadership.” 
  • and
    • “The AHA praised Congress May 23 for their support and introduction of the bipartisan Hospital Inpatient Services Modernization Act, which would grant a five-year extension to the hospital-at-home program. 
    • “Standing up a H@H program requires logistical and technical work, with an investment of time, staff and money,” AHA wrote in letters to Senate and House leaders. “In addition to being approved for the federal waiver, some providers must navigate additional regulatory requirements at the state level. For some, this whole process could take a year or more to complete before that first patient is seen at home. A longer extension of the H@H program would provide much-needed stability for existing programs to continue providing care to their patients, and it would give time for others to start programs allowing more patients to benefit from this innovative program.” 
  • and
    • “The AHA May 23 submitted statements for a House Ways and Means Subcommittee on Health hearing on challenges for private physician practices, and a House Budget Committee hearing on the budgetary effects of consolidation in health care. For the Ways and Means Committee hearing, AHA noted how physicians are challenged by increased costs, inadequate reimbursements and administrative burdens from public and private insurer practices.”  
  • Healthcare Dive lets us know,
    • “Drugmakers are allowed to limit and impose conditions on pharmaciesthey send discounted drugs to under the 340B program, [the U.S. Court of Appeals for the D.C. Circuit] ruled Tuesday.
    • “The ruling is a win for drug manufacturers, who were previously threatened with fines from the federal government for violating guidance regarding which pharmacies they would send discounted drugs to.
    • “The Court of Appeals upholds a prior District Court ruling, which sided with drugmakers Novartis Pharmaceuticals and United Therapeutics after they sued the HHS in 2021. It’s the latest ruling regarding the controversial 340B drug program — a separate appellate court also ruled with drugmakers early last year.”
  • STAT News tells us,
    • “An independent panel of advisers to the Food and Drug Administration recommended the agency approve Guardant Health’s blood-based colon cancer detection test. If the agency follows the recommendation, it will clear an early hurdle for the test’s broader adoption.
    • “The expert panel spent hours listening to presentations from Guardant, the FDA, and members of the public before voting on the screening test, called Shield. The panel’s nine voting members then voted on whether the test was safe, effective, and whether its benefits outweigh its risks, with eight, six, and seven panelists endorsing those views, respectively.
    • “FDA approval is a requirement for winning coverage from the Centers for Medicare and Medicaid Services, which could be the difference between Guardant’s test becoming widespread — or irrelevant.” 

From the public health and medical research front,

  • MedPage Today relates,
    • “Over the last 2 years, most new cases of mpox in the U.S. occurred in unvaccinated people, and less than 1% occurred in people who were fully vaccinated against the disease, according to CDC data.
    • “Among 32,819 U.S. mpox cases reported to the CDC from May 2022 to May 2024, only 0.8% occurred among people who had received two doses of the mpox vaccine Jynneos, while 75% of cases occurred among unvaccinated people, reported Sarah Anne Guagliardo, PhD, of the CDC’s Mpox National Response Team, and colleagues in the Morbidity and Mortality Weekly Report.
    • “Despite a perceived increase in [mpox] infections among fully vaccinated persons during 2024, this report indicates that, to date, persistent vaccine-derived immunologic response among persons who received the 2-dose vaccine series exists,” the authors wrote.”
  • and
    • “An at-school vaccination program in France significantly increased human papillomavirus (HPV) vaccine coverage, according to results of the PrevHPV cluster randomized trial.
    • “Among girls and boys ages 11 to 14 years, a school-based program offering HPV vaccinations significantly increased median HPV vaccination coverage by an adjusted 5.5 percentage points after 2 months of the intervention, Morgane Michel, PhD, of the Universite Paris Cite, and colleagues reported in JAMA Network Open.
    • “The intervention consisted of three components: free at-school HPV vaccination, education and motivation of adolescents and their parents, and a training program for general practitioners (GPs). “Free HPV vaccination on school premises was the only component that consistently and significantly increased vaccination coverage,” Michel and colleagues wrote.”
  • STAT News observes,
    • “You’d think if there were a vaccine that would prevent tens of thousands of cases of cancer a year, people would want it for themselves and for their kids.
    • “But new data being released Thursday ahead of the annual meeting of the American Society of Clinical Oncology show that just isn’t the case.
    • “The data showed that the vaccine reduced the risk of HPV-related cancers by 56% in men and 36% in women — numbers that actually probably understate the efficacy of the vaccine because participants in this observational study likely got the vaccine too late to prevent all HPV infections. The data were analyzed by researchers led by Jefferson DeKloe, a research fellow at Thomas Jefferson University. * * *
    • “There is not really any debate, at this point, that this vaccine would prevent tens of thousands of cases of cancer a year if it were used more widely. It’s a miraculous product, and we should be using it.”
  • KFF reports
    • “This brief examines disparities in mental health care by race and ethnicity and other factors based on data from the 2023 KFF Racism, Discrimination and Health Survey, a large, nationally representative survey based on responses from over 6,000 adults. The survey provides unique data on access to the health care system and how factors such as racism and discrimination impact these experiences and overall health and well-being. Key findings include:
    • “Among adults who report fair or poor mental health, White adults (50%) are more likely to say they received mental health services in the past three years compared with Black (39%) and Hispanic adults (36%). Across racial and ethnic groups, about half of all adults (53%) who report that they received mental health services said they were very or extremely helpful.
    • “Adults identify cost concerns and scheduling difficulties as primary barriers to mental health care, and Hispanic, Black, and Asian adults disproportionately report additional challenges, such as finding a provider who can understand their background and experiences, lack of information, or stigma or embarrassment. Among adults who received or tried to receive mental health care, Asian (55%), and Black (46%) adults are more likely to report difficulty finding a provider who could understand their background and experiences compared to their White counterparts (38%). Among those who thought they needed mental health care but did not try to find a provider, Hispanic adults are more likely than White adults to say the main reason was they didn’t know how to find a provider (24% vs. 11%) and/or that they were afraid or embarrassed to seek care (30% vs. 18%).
    • “Adults who report unfair treatment or negative experiences with a provider are twice as likely as those without these experiences to say they went without needed mental health care. Four in ten (41%) adults who report they were treated unfairly or with disrespect by a health care provider and about one-third (35%) of adults who say they’ve had at least one negative experience with a health care provider say they did not get mental health services they thought they needed compared to smaller shares of those who do not report these experiences (18% and 15%, respectively).
    • “Reported awareness of the 9-8-8 mental health hotline remains low overall, particularly among Black, Hispanic, and Asian adults. As of Summer 2023, about one in five (18%) adults say they have heard a lot or some about 9-8-8, with Black (16%), Hispanic (11%), and Asian (13%) adults less likely to say they have heard about 9-8-8 than White adults (21%). At the same time, about one in five (21%) adults say they or a family member has ever experienced a severe mental health crisis that resulted in serious consequences such as homelessness, hospitalization, incarceration, self-harm, or suicide, with this share rising to 39% among young (ages 18-29) White adults.”
  • and
    • “Alcohol use disorder (AUD) is often an underrecognized substance use disorder (SUD) despite its substantial consequences. Over half of US adults (54%) say that someone in their family has struggled with an alcohol use disorder, making it the most prevalent non-tobacco substance use disorder. Yet, only one-third of adults view alcohol addiction as a crisis, compared to over half who see opioids as such. Federal data show that 1 in 10 people had an alcohol use disorder in the past year, over 4 in 10 alcohol users report binge drinking in the past month, and per capita alcohol consumption is higher than the decade prior. Treatment rates for alcohol use disorders are notably low, especially for the use of medication, a recommended AUD treatment component. Although the opioid crisis has been declared a public health emergency by the U.S. Department of Health and Human Services since 2017, no similar declaration exists regarding alcohol deaths. However, HHS has set a priority goal of reducing emergency department visits for acute alcohol use, mental health conditions, suicide attempts, and drug overdoses by 10% by 2025.”
  • The Washington Post adds,
    • “More people in the United States say they are using marijuana daily or near daily, compared with people who say they are drinking alcohol that often, according to a new study.
    • “In 2022, about 17.7 million people reported daily or near-daily marijuana use, compared with 14.7 million people who reported drinking at the same frequency, said the report, which was based on more than four decades of data from the National Survey on Drug Use and Health. It was the first time the survey recorded more frequent users of cannabis than alcohol, the report added.
    • “The research was published Wednesday in the peer-reviewed journal Addiction. The research window spans the years 1979 to 2022, and the 27 surveys that were analyzed involved more than 1.6 million participants during that time frame.”
  • STAT News reports,
    • “Enticed by the immense market opened by GLP-1 weight loss drugs Wegovy and Zepbound, a handful of biotech companies are trying to develop next-generation, longer-lasting therapies based on a very different approach: RNA interference.
    • “This Nobel Prize-winning science works by degrading the biological blueprints that RNA use to make proteins — without the genetic instructions, the troublesome proteins are never made and the gene is essentially muted.
    • “If the companies succeed, it would be a significant shift in the obesity treatment revolution, away from weekly drugs targeting hormones to medications that could be given much less frequently — twice a year or even less — and pinpoint genetic contributors to weight.
    • “Scientists at Regeneron and Alnylam are aiming to silence a gene expressed in the brain called GPR75, what Regeneron Chief Scientific Officer George Yancopoulos calls the “laziness gene.” Through sequencing of almost 650,000 people, they found that those with a mutation to the gene have a lower body-mass index and lower risk of obesity.
    • “Alnylam has also homed in on the INHBE gene, expressed in the liver. Scientists found that people with mutations in the gene have a lower waist-to-hip ratio — a surrogate for abdominal fat, the type of fat that’s especially harmful and is linked to cardiovascular problems. Other companies like Wave Life Sciences and Arrowhead Pharmaceuticals have caught on and are also pursuing RNAi therapies aimed at blocking INHBE.”
  • Medscape explains the scientific impact of the recent creation of a map of the human ovary.
  • BioPharma Dive takes “An early look at cancer drug study results; Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting give a peek at anticipated datasets from Immunocore, Merck & Co., J&J and Arcus.”
  • The NIH Director writes in her blog,
    • “Human consciousness requires a person to be both awake and aware. While neuroscientists have learned a great deal from research about the underlying brain networks that sustain awareness, surprisingly little has been known about the networks that keep us awake.
    • “Now, an NIH-supported team of researchers has mapped the connectivity of a neural network they suggest is essential for wakefulness, or arousal, in the human brain. According to the researchers, this advance, reported in Science Translational Medicine , is essential for understanding human consciousness. It may also lead to new ways of understanding what happens in the brain when people lose consciousness, with potentially important implications for treating those who have entered a coma or vegetative state.
    • “The team—led by Brian Edlow , Massachusetts General Hospital and Harvard Medical School, Boston, and Hannah Kinney , Boston Children’s Hospital and Harvard Medical School—set out to map the brain network that sustains wakefulness in a manner similar to earlier research that identified the default mode network, which influences awareness. Default networks in the brain are most active when people are at rest rather than focused on a goal-oriented task.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Express Scripts — one of the largest pharmacy benefit managers in the country — has notched a major partnership with independent pharmacies, amid contentious relations between the two industries.
    • “The Cigna-owned PBM unveiled a collaboration on Thursday with pharmacy network CPESN USA to coordinate care delivery for seniors on Medicare with hypertension and diabetes, two common chronic conditions. CPESN’s independent pharmacies will also help identify at-risk patients and improve medication management, according to a release.
    • “Express Scripts and CPESN plan to expand the partnership based on client feedback, said a spokesperson for Evernorth, Cigna’s health services business and the division that includes Express Scripts. Financial terms of the partnership were not disclosed.”
  • Per Fierce Healthcare,
    • “After several years of modest or declining growth, the average pay for doctors jumped 5.9% in 2023, rebounding from a decline of 2.4% in 2022.”After several years of modest or declining growth, the average pay for doctors jumped 5.9% in 2023, rebounding from a decline of 2.4% in 2022.
    • “Most medical specialties experienced positive growth in 2023, with the top 10 seeing annual growth rates exceeding 7%, according to the 2024 Physician Compensation Report from professional medical network Doximity. 
    • “Among specialties, hematology and family medicine claimed the top two spots, with double-digit percentage growth compared to 2022 (12.4% and 10.2%, respectively).” 
  • Beckers Hospital Review lists the forty highest paid physician specialties based on this report.
  • Beckers Health IT calls attention to Newsweek’s list of “the top digital health companies in the U.S. for 2024, including a breakout of 50 data analytics companies.”
  • Beckers Hospital Review identifies “10 new drug shortages, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.”

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.

Monday Roundup

David Ermer–Congress, FDA, Generative AI, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Healthcare Dive reports,
    • “The Senate Finance Committee is considering policies to create more stability in Medicare payments for doctors, an update cheered by physician groups that have long lobbied for reforming how the insurance program reimburses clinicians.
    • “Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, released the white paper on Friday proposing Medicare adjust payments to account for inflation, a key goal for physicians that argue government reimbursement hasn’t kept pace with rising costs.
    • “The Senate Finance Committee is also interested in exploring ways to use incentives to increase provider participation in alternative payment models, and potential changes to Medicare’s budget neutrality requirements, which require the CMS to cut payment to certain specialties to raise it for others.”
  • Fedweek tells us
    • The Senate Homeland Security and Governmental Affairs Committee has passed:
      • S-4035, to require that when FEHB enrollees seek to add a family member to their coverage based on a qualifying life event that the event has occurred and that the individual is eligible for coverage; require the OPM to consider coverage of ineligible individuals when conducting FEHB fraud risk assessments; require a comprehensive audit be conducted of family members currently enrolled; and require OPM to disenroll any ineligible individual found to be receiving FEHB coverage.
  • STAT News lets us know,
    • “Executives from the three major pharmacy benefit manager companies have been invited to testify before the House Committee on Oversight and Accountability next month, four sources familiar with the planning told STAT.
    • “Executives from Optum, CVS Caremark, and Express Scripts, owned by Cigna, were asked to testify before the panel on June 4. * * *
    • “Lawmakers are next eyeing action in December, when a number of health care programs and authorities are expiring.
    • “Ipsita Smolinski, founder and managing director of the consulting firm Capitol Street, said she believes some PBM reforms will pass in December, but not ones that are detrimental to the industry’s business model.
    • “They are largely Medicare and Medicaid, and provide minimal system savings,” she said.”
  • The U.S. Office of Personnel Management announced,
    • “Today, the U.S. Office of Personnel Management (OPM) highlights key actions taken to recruit, hire, and train AI and AI-related talent into the federal government. OPM’s efforts support the AI in Government Act of 2020 and President Biden’s landmark Executive Order on Safe, Secure, and Trustworthy AI.   
    • “Recruiting AI talent ensures the federal government can use the latest technology to tackle global challenges, improve government services, and better support the American public,” said OPM Acting Director Rob Shriver. “As a strategic partner to federal agencies, OPM has taken a number of actions that will set agencies up to compete for top talent in this critical field now and in the future.” 

From the public health and medical research front,

  • The Washington Post and Consumer Reports tell us about “Heart checkups you should have and those you can probably skip.”
  • Per MedTech Dive,
    • “Physician enthusiasm for new pulsed field ablation systems suggests the treatment will be rapidly adopted, to the benefit of device makers bringing the products to market, said analysts who attended the Heart Rhythm Society’s (HRS) annual meeting over the weekend.
    • “Talk about pulsed field ablation (PFA), a catheter-based cardiac ablation technique to treat atrial fibrillation (AFib), dominated the meeting in Boston.
    • “The amount of data and discussions on pulsed field ablation (PFA) was almost overwhelming, with late-breaking data presentations packed by physicians,” Citi Research analyst Joanne Wuensch said in a report to clients Sunday. * * *
    • “PFA is seen as a potentially safer alternative to traditional radiofrequency and cryoablation to treat AFib, the most common form of irregular heart rhythm. Shorter operating times are viewed as another advantage.
    • “Antiarrhythmic drugs are currently recommended as the first treatment for AFib but are associated with adverse events, according to the HRS. PFA differs from thermal ablation to disable cardiac cells by using electricity instead of heat or extreme cold.”
  • Medscape discusses how artificial intelligence fits into clinical practice.
  • MedPage Today informs us,
    • “The FDA approved the first interchangeable biosimilars to aflibercept (Eylea) to treat macular degeneration, according to an announcementopens in a new tab or window from the agency.
    • “As interchangeable biosimilars, aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz) have the same approved indications as the reference product: diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and neovascular age-related macular degeneration (AMD). Like reference aflibercept, the two biosimilars are administered via intravitreal injection.
    • “The FDA pointed out in the announcement that a biosimilar “has no clinically meaningful differences” from the reference product, which means that patients “can expect the same safety and effectiveness from the biosimilar as they would the reference product.” Interchangeability means that the biosimilar met other requirements and may be substituted for the reference product without consulting the prescriber.”

From the U.S. healthcare business front,

  • STAT News relates,
    • “Americans, especially Medicare beneficiaries, are getting more medical care these days. Demand from aging Baby Boomers is keeping people in doctor’s offices, and health care providers are continuing to build capacity post-Covid.
    • “Those trends — the same ones that tanked health insurance stocks a few weeks ago — made a strong mark on nonprofit health systems’ first quarter financial reports. STAT took a look at 20 large nonprofit health systems and found that all but four reported higher operating and net margins in the first three months of 2024 compared with the same period in 2023. Hospitals are seeing more patients and cutting down on the expensive contract labor they relied on during the Covid-19 pandemic. And they’re seeing strong investment gains on the non-operating side.”
  • The Wall Street Journal reports,
    • “Hims & Hers Health shares soared after the company said it would add injectable weight-loss drugs to its platform, granting access to the popular treatments to its telehealth patients.
    • “The company on Monday said it now offers access to GLP-1 injections in addition to its oral weight-loss treatments, giving users a broader option to choose from. It will be providing a compounded form of the injections that use the same active ingredients as the popular drugs Ozempic and Wegovy, which are facing shortages that are limiting access for some patients.
    • “The price for compounded GLP-1 injections will start at $199 a month. Its oral medication offering starts at $79 a month. Both are not available in all states.
    • “Hims & Hers said it plans to make branded GLP-1 options available to customers once consistent supply is available through the pharmacies’ wholesaler.”
  • Per Healthcare Dive,
    • “Steward offered specifics on how it intends to auction off its assets in motions filed in bankruptcy court last week, including a timeline for selling its hospitals and physician group as well as contingency plans, including possible closures, if the assets fail to lure qualified bidders.
    • “The physician-owned healthcare network, which filed for Chapter 11 bankruptcy earlier this month, operates 31 hospitals and a physician group, Stewardship Health, in Massachusetts, Arizona, Ohio, Pennsylvania, Arkansas, Louisiana, Texas and Florida. 
    • “All of its assets are up for sale — and Steward is looking to sell quickly, according to the filings.
    • “Steward says it is in advanced discussions with Optum and hopes to finalize an agreement in the near-term for the company to serve as the stalking horse bidder for its physician group, Stewardship Health — the initial bid that sets the floor price during auction.” 
  • NBC News notes,
    • “Many of the ADHD medication shortages that have plagued the U.S. for the last two years have now been resolved, the Food and Drug Administration says. Yet some doctors and patients report they are still struggling to get prescriptions filled.
    • “Dr. Royce Lee, a psychiatrist at the University of Chicago Medicine, said supply has gotten better but it’s still an issue for about a third of the patients he writes prescriptions for. This often means he still has to call around to pharmacies to see if they have the medications in stock, switch patients to different drugs, and deal with insurance companies to confirm coverage.
    • “I do see signs of the shortages easing up,” Lee said. “But there are still enough shortages that every day we’re having to put in a little bit of work for prescriptions that need to be changed or hunted down.”
    • “I think a lot of people are still not getting their treatments,” he added.”

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.” 

Friday Factoids

David Ermer–CDC, Congress, COVID-19 vaccine, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Govexec reports,
    • “In the face of mounting pressure from lawmakers of all political stripes, watchdogs, stakeholders and even members of its own governing board, as well as another financial quarter in the red, leadership of the U.S. Postal Service is doubling down on its controversial plan to overhaul the agency. 
    • “USPS posted a net loss of $1.5 billion in the second quarter of fiscal 2024, though management noted that was trimmed to a $300 million loss after dispensing with costs outside of its control. USPS leaders boasted they have turned a $200 million profit in the first half of the fiscal year using that same metric, which marked a $600 million turnaround compared to the first six months of fiscal 2023.
    • “While First-Class mail volume has continued its longstanding decline, revenue grew in the quarter by nearly $500 million due in large part to the dramatic price increases USPS has instituted. The Postal Service has cut $100 million in costs, driven largely by a reduction in transportation expenses and slashing 9 million work hours. 
    • “On-time delivery of mail, however, has plummeted as USPS has instituted significant reforms to its network as laid out in Postmaster General Louis DeJoy’s 10-year Delivering for America plan.” 
  • HHS posted a fact sheet on new government efforts to reduce the impact of spread of avian flu H5N1
  • Senators John Fetterman (D PA) and Tina Smith (D MN) announced a bill, “the United States Senate Commission on Mental Health Act of 2024. The bill would establish a U.S. Senate Commission on Mental Health tasked with providing Congress and the president independent, expert policy recommendations to improve access to and affordability of mental health care services. * * * Full text of the bill can be found here.“

From the public health and medical research front,

  • The Centers for Disease Control tells us today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, 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, influenza and RSV test positivity decreased compared to the previous week. COVID-19 test positivity remained stable at low levels.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, is minimal.”
  • STAT News reports “Harvard scientists unveil the most detailed map of the brain ever: ‘It’s an alien world inside your own head’”.
    • “On Thursday, [Dr. Jeffrey’ Lichtman and his partners unveiled the results of their [decade long] efforts in the prestigious journal Science, and also posted to the internet renderings of the human brain unlike any ever seen. They came complete with a program that allows viewers to move through a microscopic alien landscape so detailed Lichtman can’t resist waxing poetic when he talks about it.
    • “It’s an alien world inside your own head,” he said. “Neurons themselves are truly awe inspiringly beautiful. There’s no two ways about it.”
    • “True, the insights gleaned from the tiny sample have not yet unraveled the mysteries of autism, schizophrenia, or depression. They can’t yet explain the mechanics of human learning, memory, and personality on the cellular level. But they represent an important first step in that direction, and provide a tantalizing preview of the kind of insights we might see in the decades ahead.”
  • The Wall Street Journal reports,
    • “Bristol Myers Squibb said on Friday that its trial evaluating a combination of cancer treatments failed to meet its primary endpoint.
    • “The company’s trial was evaluating the cancer-drug Opdivo and concurrent chemoradiotherapy, followed by Opdivo plus Yervoy, the brand name for a monoclonal antibody, in treating unresectable, locally advanced non-small cell lung cancer. The trial’s primary endpoint was progression-free survival.
    • “Bristol Myers Squibb said it would fully evaluate the data and work with investigators to share results with the scientific community.
    • “Opdivo and certain combinations with Opdivo are approved treatments for eligible patients with non-small cell lung cancer.”
  • Per Fierce Healthcare,
    • “Cancer diagnoses are on the rise among younger adults, and a new guidebook seeks to arm employers with the tools necessary to tackle this issue.
    • “The Northeast Business Group on Health’s new toolkit highlights actions employers can take to proactively address growing rates for five types of cancer in their workforce: breast cancer, colorectal cancer, head and neck cancer, cancer of the reproductive organs and skin cancer.
    • “There’s a clear business case for putting a focus on cancer, as the cost of therapies continues to increase and patients often require treatment for the long haul, NEBGH Medical Director Mark Cunningham-Hill, M.D., told Fierce Healthcare.
    • “He said that many employers, especially larger firms, have established sophisticated and comprehensive wellness and health programs for their workers. But they can do more to “connect the dots” between those offerings and critical preventive care around cancer and conditions that increase risk factors, like obesity.”
  • USA Data relates,
    • One out of every 42 babies born in the United States in 2021 was conceived using IVF or other assisted reproductive technologies.  
    • Parents who started treatments in 2021 gave birth to 97,128 babies, a 49% increase from 2012. In 2021, 238,126 patients initiated 413,776 IVF or similar treatment cycles, up 135% from 2012. 
    • IVF was most common in Washington, DC, with 5.8% of babies conceived via IVF, Massachusetts (5.4%), and New Jersey (5.0%). Less than one percent of infants born in Puerto Rico were conceived via IVF (0.4%). Alabama (0.6%) and Arkansas (0.7%) also had low rates.  

From the U.S. healthcare business front,

  • The Kaiser Family Foundation released a “KFF Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs.” Here are the key finding from the poll:
    • “The latest KFF Health Tracking Poll finds that about one in eight adults (12%) say they have ever taken a GLP-1 agonist – an increasingly popular class of prescription drugs used for weight loss and to treat diabetes or prevent heart attacks or strokes for adults with heart disease – including 6% who say they are currently taking such a drug. The share who report ever taking these drugs rises to four in ten (43%) among adults who have been told by a doctor that they have diabetes, a quarter who have been told they have heart disease, and one in five (22%) who have been told by a doctor that they are overweight or obese in the past five years1. Public awareness of GLP-1 drugs has increased in the past year, with about one-third (32%) of adults now saying they have heard “a lot” about these drugs, up from 19% in July 2023.
    • “Most adults who have taken GLP-1 drugs say they took them to treat a chronic condition including diabetes or heart disease (62%), while about four in ten say they took them primarily to lose weight.
    • “About half (54%) of all adults who have taken GLP-1 drugs say it was difficult to afford the cost, including one in five (22%) who say it was “very difficult.” While most insured adults who have taken these drugs say their insurance covered at least part of the cost, even among insured adults about half (53%) say the cost was difficult to afford2.
    • “While 8% of adults ages 65 and older say they have taken a GLP-1 medication for a chronic condition, just 1% say they have ever taken a GLP-1 drug to lose weight, which may reflect Medicare’s lack of coverage for prescription drugs used for weight loss. Nearly four in ten (37%) adults ages 65 and older report being told by a doctor they are overweight or obese in the past five years.
    • “With Medicare currently prohibited by law from covering prescription drugs used for weight loss, six in ten adults say they think Medicare should cover the cost of these drugs when prescribed for weight loss for people who are overweight, including more than half of Democrats, independents and Republicans. Similar shares of the public continue to support Medicare coverage of these drugs for weight loss even after hearing arguments for and against this proposal.”
  • Per BioPharma Dive,
    • “Sanofi will pay vaccine maker Novavax $500 million and take a small equity stake in the Maryland-based company as part of a broad COVID-19 shot alliance, the companies announced Friday.
    • “Through the deal, Sanofi will gain rights to co-market Novavax’s protein-based COVID vaccine globally, excepting certain countries, and a license to combine it with Sanofi’s existing influenza shots. Sanofi will also hold a non-exclusive right to use Novavax’s soap bark tree-derived adjuvant in other products it develops.
    • “Starting next year, Sanofi will book sales of Novavax’s COVID shot and pay Novavax double-digit percentage royalties. The French pharmaceutical company will also support certain R&D, regulatory and commercial expenses.”
  • Per MedTech Dive,
    • “Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.”Tandem Diabetes Care is recalling a version of its t:connect app for iPhone because of a fault that could drain insulin pump batteries, the Food and Drug Administration said Wednesday.
    • “After updating the app in February, Tandem received 224 injury reports in about two months. The reports related to an issue that caused the app to crash and relaunch, resulting in excessive use of Bluetooth and potentially draining the battery of the connected insulin pump.
    • “The FDA categorized the event as a Class I recall because of the life-threatening potential for pumps to deliver too little insulin. Tandem corrected the fault in an app update in March.”
  • The Wall Street Journal explains why “Getting Alzheimer’s treatment to those who need it poses particular challenges.” For example
    • “The problem isn’t this drug. Sure. It has risks, et cetera,” said Jason Karlawish, co-director, of the Penn Memory Center at the University of Pennsylvania. “But the problem was the drug and the system — namely with a system of care for its delivery.”
    • “Karlawish said his memory center infused its first patient with Leqembi on November 16. He said that in the six months since, the number of patients who have received the drug there has climbed into the double-digits, reaching roughly 50 people. That, he said, required setting up an infrastructure that “either didn’t exist or existed in bits that had to be put together.”
  • MedCity new points out,
    • “Navigation challenges are the top reason consumers stop seeing healthcare providers, while experience issues are the main reason consumers leave their health insurer, a new survey found.
    • “The Accenture report, released last week, surveyed more than 9,700 insured consumers and 8,000 consumers who sought or received care in the prior year. The survey is a follow-up to a 2021 report, which examined why people are loyal or not loyal to their payer or provider.
    • “We wanted to leverage our patient and member experience surveys to continue to track the state of consumerism in health care, assessing how providers and health insurers perform across a number of key touchpoints that drive selection, loyalty, value and ease of use,” said Sarah Sinha, a managing director in Accenture’s health business, in an email.”
  • Insurance Business tells us,
    • “Offering support across a variety of functions including customer service, claims processing, underwriting, and fraud detection, the capability of AI to analyze large datasets and process information will continue to revolutionize insurance.
    • “Nirmal Ranganathan, vice president of engineering, AI, at Rackspace Technology, spoke with Insurance Business on how insurance companies can take advantage of AI to generate cost savings across their businesses.”
    • Check it out.

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, Federal employment benefits, HSA, Medical / Rx research, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “The House overwhelmingly voted to table Rep. Marjorie Taylor Greene’s attempt to oust Speaker Mike Johnson on Wednesday night, with nearly all Republicans and most Democrats coming to Johnson’s rescue.
    • “The final tally was 359-43, with 11 Republicans and 32 Democrats voting against the motion to table Greene’s resolution. Seven Democrats voted “present.”
  • The Society for Human Resource Management tells us,
    • “The annual limit on HSA contributions for self-only coverage in 2025 will be $4,300, a 3.6 percent increase from the $4,150 limit in 2024, the IRS announced May 9. For family coverage, the HSA contribution limit will jump to $8,550, up 3 percent from $8,300 in 2024.
    • “The jump in the contribution limits is significantly less than the roughly 7 percent increase seen from 2023 to 2024.
    • “The IRS did not yet release the 2025 catch-up contribution for savers age 55 and older. It currently stands at $1,000 for 2024, unchanged from 2023.
    • “Meanwhile, for 2025, a high-deductible health plan (HDHP) must have a deductible of at least $1,650 for self-only coverage, up from $1,600 in 2024, or $3,300 for family coverage, up from $3,200, the IRS noted. Annual out-of-pocket expense maximums (deductibles, co-payments and other amounts, but not premiums) cannot exceed $8,300 for self-only coverage in 2025, up from $8,050 in 2024, or $16,600 for family coverage, up from $16,100.
    • “The IRS also announced that the excepted-benefit HRA limit will be $2,150 in 2025, up from $2,100.”
  • Here’s a link to the IRS announcement.
  • Fierce Healthcare points out,
    • “The U.S. Department of Justice announced Thursday it has established a new task force to take on healthcare monopolies and collusion.
    • “The task force, called HCMC for short, will guide the division’s enforcement strategy and policy approach in healthcare, including by facilitating policy advocacy, investigations and, where warranted, civil and criminal enforcement in healthcare markets, the agency said in a press release.”
  • Govexec lets us know,
    • “The Office of Personnel Management continued to make gains in its backlog of federal employees’ pending retirement applications, though progress has begun to slow.
    • “The federal government’s dedicated HR agency processed 7,647 claims in April. That marks a sharp decrease from the 10,711 claims handled in March but remains above the 6,901 new claims OPM received last month.
    • “Overall, the backlog of pending claims ticked down to 16,077 by the end of April, a decrease of roughly 750 from March’s backlog of 16,823. The federal government’s retirement backlog has fallen 23% since January, but remains short of OPM’s “steady state” goal of 13,000 pending claims.”
  • Fedweek explains the circumstances under which an FEHB enrollee can make coverage changes outside of Open Season. Meanwhile, Reg Jones wraps up his series on FEGLI coverage.

From the public health and medical research front,

  • “U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a white paper detailing proposals to improve the National Institutes of Health (NIH). Last year, Cassidy requested feedback from stakeholders on policies Congress could consider to modernize NIH.  * * * Read the full white paper here.  
  • The NIH Director in her blog lets us know,
    • “Precision oncology, in which doctors choose cancer treatment options based on the underlying molecular or genetic signature of individual tumors, has come a long way. The Food and Drug Administration has approved a growing number of tests that look for specific genetic changes that drive cancer growth to match patients to targeted treatments. The NCI-MATCH trial, supported by the National Cancer Institute, in which participants with advanced or rare cancer had their tumors sequenced in search of genetic changes that matched them to a treatment, has also suggested benefits for guiding treatment through genetic sequencing. But there remains a need to better predict treatment responses for people with cancer.
    • “A promising approach is to analyze a tumor’s RNA in addition to its DNA. The idea is to not only better understand underlying genetic changes, but also learn how those changes impact gene activity as measured by RNA sequencing data. A recent study introduces an artificial intelligence (AI)-driven tool, dubbed PERCEPTION (PERsonalized single-Cell Expression-based Planning for Treatments In ONcology), developed by an NIH-led team to do just this.1 This proof-of-concept study, published in Nature Cancer, shows that it’s possible to fine-tune predictions of a patient’s treatment responses from bulk RNA data by zeroing in on what’s happening inside single cells.”
  • NIH announced,
    • “Starting people with opioid use disorder on extended-release, injectable naltrexone (XR-naltrexone) within five to seven days of seeking treatment is more effective than the standard treatment method of starting within 10-15 days, but requires closer medical supervision, according to results from a clinical trial(link is external) supported by the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA). Published in JAMA Network Open, the findings suggest that this rapid treatment protocol could make XR-naltrexone more viable as a treatment option for opioid use disorder, which continues to take lives at an alarming rate.
    • “When someone is ready to seek treatment for opioid use disorder, it is crucial that they receive it as quickly as possible,” said Nora Volkow, M.D., NIDA director. “This study paves the way for more timely care with one of the three medications for opioid use disorder we have available, better supporting people in their ability to choose the treatment option that will work best for them.”
  • The U.S. Preventive Health Task Force made available for public comment a draft research plan about the “Early Introduction of Allergens to Prevent Food Allergies in Infants: Counseling.” The comment period ends on June 5, 2024.
  • The Institutes for Clinical and Economic Review
    • “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of imetelstat (Geron Corporation) for the treatment of anemia in myelodysplastic syndrome (MDS).
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.”
    • The comment deadline is June 10, 2024.
  • The Wall Street Journal explores the quest for treatments to keep weight off after taking blockbuster drugs such as Ozempic and Wegovy. Reading the article makes the FEHBlog think that that the drug manufacturers put the cart before the horse.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Some 23% of what patients owe is collected by hospitals before treatment, according to an analysis of first-quarter data this year from 1,850 hospitals by Kodiak Solutions, a healthcare consulting and software company. For the same period in 2022, the figure was 20%.
    • “They are seeking advance payment for nonemergencies, they say, because chasing unpaid bills is challenging and costly. Roughly half the debt hospitals wrote off last year was owed by patients with insurance, the Kodiak analysis found.
    • “We need those patients who are able to pay to do so,” said Leslie Taylor, a spokeswoman for University of Arkansas for Medical Sciences, which owns one general hospital in Arkansas and will—after discussing with doctors—reschedule some procedures until patients can pay.
    • “For patients, the hospitals say, knowing the cost ahead of service gives them the opportunity to comparison-shop and avoid getting walloped with a huge bill unexpectedly. * * *
    • “Still, finding money for treatment is a challenge for many American households. Half of adults say they can’t afford to spend more than $500 on medical care should they be suddenly sick or injured, a survey by health policy nonprofit KFF found. They would need to borrow. 
    • “In addition, determining how much a patient will owe can be tricky. How much each patient pays depends on their health plan, its deductible or other out-of-pocket costs and the prices the plan negotiated with a hospital to pay.” 
  • Fierce Healthcare relates that doctors are trying to add a CPT code for prior authorization which would give them health plan reimbursement for this administrative services.
  • MedTech Dive alerts us that “Surgical robots are ‘gift that will keep on giving,’ ortho firms say. Stryker, Zimmer and Globus reported double-digit sales growth in their robot segments and outlined plans for new products.”
    • “Orthopedics companies posted record robot sales in the first quarter, even as they plan new product launches in the second half of 2024.
    • “Stryker reported record installations of its Mako surgical robot in the first quarter, although it didn’t share an exact number. Jason Beach, Stryker’s vice president of finance and investor relations, said the company has seen “really good results” from direct-to-consumer ads promoting the surgical robot to people who might consider a hip or knee replacement.” 
  • Per BioPharma Dive,
    • “AstraZeneca will no longer manufacture or supply its COVID-19 vaccine Vaxzevria, announcing Tuesday it is voluntarily withdrawing the shot due to a “decline in demand,” a spokesperson wrote in an email to BioPharma Dive. 
    • “Prior to the announcement, the company had already taken steps to pull Vaxzevria from the market in Europe. It submitted a withdrawal request there in March which took effect on May 7. 
    • “The decision to withdraw the vaccine comes just after the company reported plummeting yearly sales for Vaxzevria, and reportedly admitted in court documents that the shot can cause a rare side effect that leads to a combination of blood clots and low platelet levels. AstraZeneca didn’t mention safety concerns as a reason for the vaccine’s withdrawal, however.”  

Midweek Update

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

From Washington, DC

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

From the Food and Drug Administration front,

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

From the public health and medical research front

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

From the U.S. healthcare business front,

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

Tuesday Tidbits

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

From Washington DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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