Midweek update

Telehealth

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Generative AI, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Mount Rushmore

From Washington, DC —

  • STAT News reports
    • “Senators on the Finance Committee on Wednesday nearly unanimously passed a bill to clamp down on drug middlemen but kicked the can down the road on some of the more challenging policies.
    • “The bill would offer some more transparency into the business practices of pharmacy benefit managers, ensure PBMs aren’t skimming off of the money they send to insurers, prohibit them from overcharging insurers, and ensure certain fees in the Medicare program aren’t tied to a drug’s price.”
  • From the Senate Finance Committee, “click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • The House Ways and Means Committee relates,
    • “Congresswoman Nicole Malliotakis, a member of the House Committee on Ways and Means, today announced her legislation, the Protecting Patients from Middlemen Act, passed out of the full committee and will be included in the committee’s Health Care Price Transparency Act of 2023.
    • “Specifically, Malliotakis’ legislation, which was introduced in partnership with Rep. Brad Wenstrup (OH-02), would prohibit prescription drug plans and Pharmacy Benefit Managers (PBMs) in Medicare Part D or Medicare Advantage from charging patients more in drug cost-sharing that the net price of the drug.”
  • AHA News tells us,
    • “The House Ways and Means Committee July 26 voted 25-16 to pass the Health Care Price Transparency Act (H.R. 4822), legislation that would impose additional site-neutral payment cuts and regulatory burdens on off-campus hospital outpatient departments, impose additional Medicare sequester cuts on hospitals, and codify and make changes to hospital price transparency regulations. * * *
    • “In other action today, the committee voted 23-17 to pass the Providers and Payers COMPETE Act (H.R. 3284), AHA-opposed legislation that would impose new regulatory responsibilities on the Department of Health and Human Services regarding consolidation.”
  • Federal News Network informs us,
    • “Federal retirees, and employees looking to retire, have some new resources to help them through the often long and thorny retirement process.
    • “A new series of video tutorials from the Office of Personnel Management lays out, step by step, a couple of key items on the federal retirement to-do list.
    • “With the three new videos, OPM said it hopes to reduce the number of errors from federal retirees when trying to log in to manage their online retirement accounts. And in theory, the videos should also help reduce wait times at retirement services call centers, OPM said, now that more detailed information is readily available to feds who get caught up in some of the early steps of the process.”
  • Forbes reports
    • “The FDA has approved Octapharma’s drug Balfaxar, which is used by patients who require surgery but have seen a reduction in blood clotting factors due to being treated with the blood thinner warfarin.” 

From the public health front —

  • Employee Benefits News offers expert views on the current state of Covid.
  • The National Institutes of Health announced
    • “Researchers have found that people with obstructive sleep apnea have an increased cardiovascular risk due to reduced blood oxygen levels, largely explained by interrupted breathing. Obstructive sleep apnea has long been associated with an increased risk of cardiovascular issues, including heart attack, stroke, and death, but the findings from this study, partially supported by the National Institutes of Health and published in the American Journal of Respiratory and Critical Care Medicine, show the mechanism mostly responsible for the link.
    • “These findings will help better characterize high-risk versions of obstructive sleep apnea,” said Ali Azarbarzin, Ph.D., a study author and director of the Sleep Apnea Health Outcomes Research Group at Brigham and Women’s Hospital and Harvard Medical School, Boston. “We think that including a higher-risk version of obstructive sleep apnea in a randomized clinical trial would hopefully show that treating sleep apnea could help prevent future cardiovascular outcomes.”
  • Medscape considers where exercise boosts cognition.
  • Fierce Healthcare lets us know,
    • “One in three counties in the U.S. is considered a maternal healthcare desert.
    • “Since that statistic was dropped back in October 2022 by March of Dimes, care in corners of the country has only continued to dry up. In response to the crisis, providers are using every seed in their seed bag and looking to “multimodal” technology strategies to predict health emergencies before they happen.
    • “Those multimodal approaches combine telehealth, remote patient monitoring (RPM) and text messages to identify high-risk patients. High blood pressure monitoring and hypertension screening are currently recommended for pregnant patients by the U.S. Preventive Services Task Force, as heart disease and stroke are two of the leading causes of maternal mortality.
    • “Lucienne Ide, M.D., is the CEO of the digital health company Rimidi. She sees the country teetering on an inflection point.
      • “We’re at this fork in the road of looking at what we could do with technology, identifying high-risk women and getting them into the programs where we’re proactively and earlier identifying something dangerous and doing something about it,” Ide told Fierce Healthcare.
      • “But the alternate narrative is really, really bad, and it’s going to get worse. It’s not like, ‘Here we are today, and we could do better.’ No, here we are today, and it’s going to get worse, but we can actually do better,” she said.

From the U.S. healthcare business front —

  • Per Fierce Healthcare,
    • “As hospitals acquire ambulatory care centers, consumers are more likely to be forced to pay outpatient facility fees for routine care traditionally covered by physician offices at lower costs.
    • “These new costs, appearing seemingly out of nowhere to the average consumer through out-of-pocket spending and premium increases, can add up to hundreds or thousands of dollars in additional expenses for a patient, according to a report from Georgetown University’s Center on Health Insurance Reforms.
    • “Outpatient facility fees cover a hospital’s operational expenses. But when hospitals acquire physician practices, that usually generates another outpatient facility bill, eventually passing on the cost to the patient. Consumers are often unaware that they are now responsible for an extra cost.”
  • Healio reports that the growth of telehealth in cancer care continued after the initial surge during the COVID-19 pandemic.
  • Per Healthcare Dive, the path toward reducing physician burnout is widening.
    • “Amazon has become the latest tech giant to announce a clinical documentation service that allows providers to automatically create medical notes using generative AI.
    • “The Amazon Web Services tool announced Wednesday, called HealthScribe, allows providers to build clinical applications that use speech recognition and generative AI to create transcripts of patient visits, identify key details and create summaries that can be entered into an electronic health record.
    • “HealthScribe is being previewed for two specialties: general medicine and orthopedics. An Amazon spokesperson said AWS could expand to additional specialties based on client feedback. HealthScribe costs users a set amount per second of audio processed each month.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, COVID-19, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Department of Labor announced
  • STAT News adds,
    • “The new rule would force insurers to evaluate their own networks to measure not just whether they’re offering adequate mental health and addiction coverage but also whether patients are truly accessing it.
    • “This rule will ensure that we have true parity,” Neera Tanden, President Biden’s domestic policy advisor, said during a press call. “It will help ensure we finally fulfill the promise of mental health parity required under the law, to ensure that mental health is covered just like physical health.”
  • The public comment deadline will occur in late September.
  • The FEHBlog notes that health plans cannot coerce providers into their networks. The FEHBlog thought that hub and spoke tele-mental health networks would fill the gap, but that apparently hasn’t happened.
  • AHIP announced
    • “AHIP, the American Medical Association (AMA), and the National Association of ACOs (NAACOS) today announced the release of data-sharing best practices that organizations may voluntarily adopt to support a sustainable future for value-based care. The playbook, The Future of Sustainable Value-Based Care and Payment: Voluntary Best Practices to Advance Data Sharing, is intended to advance the adoption of value-based care arrangements in the private sector that could have a greater impact on the quality and equity of care and ease participation by fostering voluntary alignment of data sharing practices.”
    • Check it out.
  • The National Coordinator for Health Information Technology released on July 20, 2023,
    • “ONC Standards Bulletin 2023-2 (SB23-2) [which] describes the background of United States Core Data for Interoperability (USCDI) and the development of the USCDI Version 4 (USCDI v4) * * *. USCDI is a standard developed and adopted by ONC on behalf of the U.S. Department of Health and Human Services (HHS) that sets the technical and policy foundation for the access, exchange, and use of electronic health information to support nationwide, interoperable health information exchange. USCDI benefits a wide range of entities, individuals, and other interested parties, including federal agencies supporting health and healthcare, hospitals, research organizations, clinicians, and health IT developers. ONC publishes new versions of USCDI annually, with a draft version in January and a final version in July. This publishing cadence keeps pace with medical, technological, and policy changes. USCDI v4 includes new data elements that advance the Biden-Harris Administration’s priorities of advancing equity, diversity, and access across all healthcare settings.
    • “SB23-2 describes the ONC approach for the continued expansion of USCDI, as well as the specific priorities for adding new data elements to USCDI v4. This bulletin also includes discussion of the feedback received on the Draft USCDI v4, including recommendations received from the ONC Health IT Advisory Committee (HITAC).”
  • The U.S. Preventive Services Task Force gave a draft inconclusive grade for “screening for speech and language delay and disorders in children age 5 years or younger.” The USPSTF previously gave the same grade to the screening service in 2015. The public comment deadline is August 21, 2023.
  • FedSmith notes that the OPM final rule expanding FEDVIP eligibility will add “over 70,000 federal employees and 118,000 Postal employees” to the pool of employees eligible for FEDVIP.

From the public health front —

  • U.S. News reports
    • “Both coronavirus emergency department visits and test positivity increased, according to CDC data. The agency no longer tracks COVID-19 cases. Instead, it focuses on hospitalizations and deaths, which don’t yet show an increase.
    • “The CDC reported last week that it was the first time since January that COVID-19 metrics showed an increase. The uptick is small, but it’s a notable reversal after months of declining coronavirus numbers.
    • “Certain COVID-19 indicators continued their recent rise last week, according to data from the Centers for Disease Control and Prevention.”
  • HHS’s Agency for Healthcare Research and Quality issued a roundtable report about “Optimizing Health and Function as We Age.”
  • Yahoo News tells us,
    • “Drugmaker Pfizer Inc said over 30 drugs, including injections of painkiller fentanyl and anesthetic lidocaine, may see supply disruption after a tornado destroyed a warehouse at its Rocky Mount, North Carolina, plant last week.
    • “The company sent a letter late last week to its hospital customers saying it had identified around 64 different formulations or dosages of those more than 30 drugs produced at the plant that may experience continued or new supply disruptions.
    • “The company has placed limits on how much supply of those drugs its customers can buy.”
  • Medscape shares CDC guidance about the two new RSV vaccines for adult that the FDA and CDC recently approved.
    • “Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinician, say authors of a Centers for Disease Control and Prevention report published Friday.
    • “Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.“

From the U.S. healthcare business front,

  • BioPharma Dive informs us,
    • “Biogen on Tuesday said it will eliminate 1,000 jobs as part of a cost-cutting drive that it expects will save $1 billion in annual operating expenses by 2025.
    • “The company plans to invest $300 million of those savings into product launches as well as research and development, which it has spent the first half of this year reorganizing under new CEO Chris Viehbacher.
    • “There’s been a complete redesign of Biogen,” Viehbacher said on a conference call with analysts. “This is an opportunity to make sure that in this year, before we get into [new] product launches, that we are truly fit for growth.”
  • STAT News lets us know that “As Alzheimer’s drugs hit the market, the race for early detection blood tests heats up” and offers an interview with the American Medical Association’s new president Dr. Jesse Ehrenfeld.
  • Fierce Health relates,
    • “Teladoc’s second-quarter revenue jumped 10% to $652 million, boosted by strong growth in its BetterHelp direct-to-consumer mental health segment.
    • “The telehealth giant also narrowed its losses this past quarter to a net loss of $65 million, or a loss of 40 cents per share, compared to a loss of $3 billion for the second quarter of 2022. Both results beat Wall Street estimates.
    • “The Zacks Consensus Estimate for Teladoc’s second-quarter earnings per share was pegged at a loss of 44 cents and revenue of $649 million.”

In low-value care news, the National Institutes of Health tells us, “A device known as a pessary, thought promising for reducing preterm birth risk due to a short cervix, appears no more effective than usual medical care, according to a study funded by the National Institutes of Health. A pessary is a rounded silicone device that fits around a cervix that has shortened, to keep it from opening and leading to miscarriage or preterm birth. The device is typically removed before the 37th week of pregnancy.”

Tuesday Tidbits

David Ermer–ACA, Generative AI, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front,

  • Health Affairs reports
    • “National health expenditures are projected to grow 5.4 percent, on average, over the course of 2022–31 and to account for roughly 20 percent of the economy by the end of that period. The insured share of the population is anticipated to exceed 92 percent through 2023, in part as a result of record-high Medicaid enrollment, and then decline toward 90 percent as coverage requirements related to the COVID-19 public health emergency expire. The prescription drug provisions of the Inflation Reduction Act of 2022 are anticipated to lower out-of-pocket spending for Medicare Part D enrollees beginning in 2024 and to result in savings to Medicare beginning in 2031.”
  • The U.S. Preventive Health Services Task Force gave an inconclusive grade to screening for lipid disorders in children and adolescents 20 years or younger.
  • The Wall Street Journal offers ways to protect yourself and your family against the ill effects of forever chemicals that may be in your tap water or else in your homes.

From the regulatory front,

  • The Food and Drug Administration “published a safety communication to warn consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, and Well-Being Reality. The devices have not been reviewed by the FDA. The safety and effectiveness of these devices have not been established to diagnose, treat, or cure medical conditions.”
  • HMFA informs us
    • “Hospital price transparency regulations are undergoing changes heading into their fourth year as CMS seeks to step up enforcement while making compliance more straightforward.
    • “As part of the 2024 proposed rule for hospital outpatient payments, CMS is adding to the requirement for hospitals to maintain a machine-readable file of their charges for services. In addition, enforcement actions against hospitals would be publicized even before assessment of civil monetary penalties.
    • “CMS said the impetus for the proposed technical requirements is feedback from “interested parties” that the files would be more beneficial if they were more standardized.
    • “In particular, IT specialists have indicated that the current flexibilities and lack of encoding specifications hinder the machine-readability of the data in the files, presenting a barrier to the intended use of the data,” CMS wrote. “Additionally, hospitals have asked us for more specificity on how they should publicly display their standard charge information, with an emphasis on how they should explain and display their payer-specific negotiated charges.”
    • “The agency also said enforcement would be easier if the files were more consistent.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “In the past 10 years, there has been a dramatic shift in physician practice ownership as less than half of doctors now work in private practices, according to a new analysis.
    • “Between 2012 and 2022, the share of physicians working in private practices fell by 13 percentage points from 60.1% to 46.7%.
    • “In contrast, the share of physicians working in hospitals as direct employees or contractors increased from 5.6% to 9.6% in the same 10-year time period, and the share of physicians working in practices at least partially owned by a hospital or health system increased from 23.4% to 31.3%, according to a benchmark analysis the American Medical Association. * * *
    • “In 2022, 4.5% of physicians worked in a practice owned by a private equity group, similar to the percentage in 2020 when the AMA first added private equity to the analysis.
    • “According to the analysis, there also has been a redistribution of physicians from small to large practices. The share of physicians in small practices (10 or fewer physicians) shrank from 61.4 % to 51.8% between 2012 and 2022. Conversely, the share of physicians in large practices (50 physicians or more) grew from 12.2% to 18.3% in the same 10-year time period.
    • “The shares of physicians in mid-sized practices (those with 11 to 24 and 25 to 49 physicians) remained relatively stable over the last decade.”
  • BioPharma Dive informs us,
    • “Biotechnology startup creator Flagship Pioneering is teaming up with Pfizer to develop 10 new drug candidates, with each company pledging to invest $50 million in the new effort.
    • “Together, Flagship and Pfizer will take stock of the technologies available to the former firm and its affiliated startups, hunting for opportunities to develop medicines aligned with Pfizer’s research priorities. Per deal terms announced Tuesday, Pfizer will fund the development of selected medicines, each of which it can choose to acquire later.
    • “The collaboration involves Flagship’s “Pioneering Medicines” initiative, which has struck similarly structured deals in the recent past with Novo Nordisk and the Cystic Fibrosis Foundation.”
  • Healthcare Dive relates,
    • “Teladoc Health is expanding its partnership with Microsoft, announcing plans to add artificial intelligence tools for clinical documentation to its telehealth platform for hospitals and health systems.
    • “The companies will work to integrate Microsoft Azure’s OpenAI Service and Cognitive Services and Microsoft-owned Nuance’s Dragon Ambient eXperience into its Solo platform, allowing physicians to automatically transcribe clinical notes during virtual patient exams.
    • “Teladoc’s medical group also plans to use DAX Express, a version of the medical scribe that uses the large language model GPT-4 and doesn’t require human authentication, the New York-based telehealth vendor said. Financial terms of the deal were not disclosed.”

From the Rx coverage front, the Drug Channel blog delves into the biosimilars’ challenge to Humira. The article illustrates the relatively new distinction between low-list drug prices and high-list drug prices. Low list prices do not include a manufacturer rebate. The FEHBlog understands that the distinction is driven by the Inflation Reduction Act.

Monday Roundup

David Ermer–ACA, COVID-19, FDA, Generative AI, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front —

  • The Wall Street Journal reports
    • “Parents have a new tool to protect their newborns from a common but potentially deadly respiratory virus that sends tens of thousands of babies to the hospital each year.
    • “The Food and Drug Administration on Monday approved the first drug to protect all infants against respiratory syncytial virus. RSV is the leading cause of hospitalization of infants in the U.S., killing as many as 300 children under the age of 5 each year.  
    • “The FDA said it approved the drug Beyfortus from Sanofi and AstraZeneca based on studies that found it safely prevented the lower respiratory tract infections caused by the virus. * * *
    • “While Beyfortus isn’t a vaccine, it has a similar objective. The injection gives infants antibodies to neutralize the virus before their immune systems are mature enough to generate them on their own.  * * *
    • “Sanofi plans to make Beyfortus available in time for this year’s RSV season. Before the drug can become widely available, CDC advisers will need to recommend the drug’s use.”  
  • The FEHBlog’s favorite columnist on Covid, the New York Times David Leonhardt, let us know, “The United States has reached a milestone in the long struggle against Covid: The total number of Americans dying each day — from any cause — is no longer historically abnormal.” Consequently, the pandemic era is over.
  • In other Covid news, Medscape tells us,
    • “An air monitor made by researchers at Washington University in St. Louis can detect COVID-19 virus in a room with an infected person within 5 minutes. 
    • “The project was a collaboration among researchers from the university’s engineering and medical schools. Nature Communications published the results of their work in the journal’s Monday edition. * * *
    • “The team tested their device both in laboratory experiments where they released aerosolized SARS-CoV-2 into a room-sized chamber, as well as in the apartments of two people who were COVID-positive.
    • “There is nothing at the moment that tells us how safe a room is,” Washington University neurology professor John Cirrito, Ph.D., in a statement. “If you are in a room with 100 people, you don’t want to find out 5 days later whether you could be sick or not. The idea with this device is that you can know essentially in real-time, or every 5 minutes if there is a live virus in the air.”
    • “Their goal is to develop a commercially available air quality monitor, the researchers said.” 
  • Cigna discusses how to help women to stay on track with screenings for common cancers.
  • KFF explains why different BMI standards apply to older folks. For example,
    • “Epidemiologic research suggests that the ideal body mass index (BMI) might be higher for older adults than younger adults. (BMI is a measure of a person’s weight, in kilograms or pounds, divided by the square of their height, in meters or feet.)
    • “One large, well-regarded study found that older adults at either end of the BMI spectrum — those with low BMIs (under 22) and those with high BMIs (over 33) — were at greater risk of dying earlier than those with BMIs in the middle range (22 to 32.9).
    • “Older adults with the lowest risk of earlier deaths had BMIs of 27 to 27.9. According to World Health Organization standards, this falls in the “overweight” range (25 to 29.9) and above the “healthy weight” BMI range (18.5 to 24.9). Also, many older adults whom the study found to be at the highest mortality risk — those with BMIs under 22 — would be classified as having “healthy weight” by the WHO.
    • “The study’s conclusion: “The WHO healthy weight range may not be suitable for older adults.” Instead, being overweight may be beneficial for older adults, while being notably thin can be problematic, contributing to the potential for frailty.”
  • According to STAT News,
    • “At the turn of the century, nearly 18 million women in the United States were battling hot flashes, night sweats, and other symptoms of menopause with hormones. But in 2002, the therapy went into a free-fall when a landmark trial suggested treating menopause with estrogen and progesterone increased the risk of breast cancer and cardiovascular disease. The study was shut down early — and a year later, prescriptions had plummeted to nearly half what they had been in 2001.
    • “More than two decades later, menopause experts have come to think about the results of the trial very differently. Newer research points to more benefits than risks for many healthy women under 60 treating menopause symptoms with hormone therapy. But many women who are good fits still aren’t getting treatment. “The pendulum has been slowly — too slowly — swinging back,” said OB-GYN Mike Green, chief medical officer of menopause telehealth company Winona. 
    • “Winona is part of a new generation of virtual-first health care companies aiming to give that pendulum a push. In the last five years, more than a dozen telehealth companies have started up to serve women in and approaching menopause, including with hormone therapy. 
    • “Women fall through the cracks,” said internist Lisa Larkin, president-elect of The Menopause Society and founder of concierge women’s health network Ms. Medicine. “That’s why the telemedicine business is booming.” 

From the Alzheimer’s Disease front,

  • Medscape tells us,
    • “Eastern and southeastern areas of the US have the highest rates of Alzheimer’s disease (AD), new research shows.
    • “Investigators at Rush University in Chicago, Illinois, found AD prevalence was highest in Maryland, New York, Mississippi, and Florida. At the county level, Miami-Dade in Florida, Baltimore in Maryland, and the Bronx in New York were among the US counties with the highest prevalence of the disease.
    • “Such geographical variations may be due to the unique make-up of regional populations, study investigator Kumar Rajan, PhD, professor of Medicine and director of Rush Institute for Healthy Aging, Rush University Medical Center, in Chicago, told Medscape Medical News.”
  • STAT News relates,
    • Medicare on Monday proposed ending restrictions on how many PET scans patients can receive to detect amyloid plaques in their brains, which will offer physicians more options as they treat patients with a new drug to slow the progression of dementia.
    • The agency that oversees Medicare had previously restricted coverage to a single scan for patients who participated in clinical studies. Advocates had warned that it could cause issues related to a new class of Alzheimer’s drugs designed to clear those plaques.
  • BioPharma Dive calls our attention to
    • “A closely watched experimental drug for Alzheimer’s disease slowed the decline patients typically experience by about half a year in a key clinical trial, according to new results released Monday.
    • “The drug, called donanemab, is being developed by Eli Lilly and works in a similar way as two other medicines recently approved in the U.S. to treat Alzheimer’s. These therapies are designed to break up clusters of “amyloid beta,” a mutated protein that forms toxic brain plaques and has long been viewed as a root cause of the disease. * * *
    • “Along with its presentation, Lilly disclosed it had completed its approval application to the FDA and expects a verdict by the end of the year. The results were also published in the medical journal JAMA.”
  • Reuters adds,
    • “Alzheimer’s disease experts are revamping the way doctors diagnose patients with the progressive brain disorder – the most common type of dementia – by devising a seven-point rating scale based on cognitive and biological changes in the patient.
    • “The proposed guidelines, unveiled by experts on Sunday in a report issued at an Alzheimer’s Association conference in Amsterdam, embrace a numerical staging system assessing disease progression similar to the one used in cancer diagnoses. They also eliminate the use of terms like mild, moderate and severe.”

From the generative AI front, Fierce Healthcare explains how Blue Cross licensee HCSC is using AI to speed up prior authorization.

From the U.S. healthcare business front,

  • The American Hospital Association informs us,
    • “The Federal Trade Commission July 14 voted 3-0 to withdraw two antitrust policy statements related to enforcement in health care markets, calling the 1996 and 2021 statements outdated. The Department of Justice withdrew the same statements in February.  
    • “AHA is deeply disappointed that the FTC made the same mistake as the DOJ in withdrawing antitrust guidelines for hospitals and other health care providers,” said AHA General Counsel & Secretary Melinda Hatton. “Over the years, AHA has urged both federal antitrust agencies to modernize the guidelines to accommodate the need for more flexibility in enforcement actions to support hospitals’ ability to navigate a changing healthcare landscape. And AHA was instrumental in securing appropriate ACO guidance that allowed hospitals to fully participate in that important program. Withdrawing all the guidance without consultation with the field is both unnecessary and reckless.”
  • According to STAT News,
    • “Sanofi will license a new CRISPR enzyme from the startup Scribe Therapeutics in a bid to be the first to develop a safer, simpler, and more scalable cure for sickle cell disease.
    • “The French drugmaker will pay Scribe $40 million upfront and promise another $1.2 billion in potential milestones to license a DNA-cutting enzyme called CasX for use in a potential single-infusion treatment for the serious blood disorder — what’s known as in vivo therapy. CasX was discovered in CRISPR pioneer Jennifer Doudna’s lab, which subsequently spun out Scribe. * * *
    • “The company will have competition on tackling sickle cell in new ways. In 2021, Novartis started collaborating with the Gates Foundation to develop an in vivo therapy. The base editing company Beam Therapeutics has presented data on an approach that still requires cells to be edited outside the body but is much less toxic. And Sana Biotechnology has a program that hopes to target stem cells with virus-like particles. None of the companies, however, have yet begun clinical trials. 

In employment news,

  • HR Dive reports,
    • “The Occupational Safety and Health Administration published Friday its final electronic recordkeeping rule requiring employers with 100 or more employees in certain industries to submit information from the agency’s Forms 300 and 301 once per year.
    • “OSHA’s rule also updates its system for determining which industries are subject to the information submission requirement. In a departure from the proposed rule, OSHA has retained the requirement for employers with 250 or more employees to electronically submit information from Form 300A once per year. Additionally, employers with 20 to 249 employees in certain designated industries will continue to be required to electronically submit information from Form 300A once per year.
    • “Per the rule, the agency will post data gathered via these submissions on a public website, with identifying information — such as employees’ names and contact information — removed. The final rule is effective Jan. 1, 2024.”

Midweek update

David Ermer–CMS, Congress, COVID-19, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC —

  • Politico reports,
    • “The Senate Finance Committee is releasing the next in its parade of legislation targeted at pharmacy benefit managers — an industry that Democrats and Republicans on Capitol Hill argue drives up the cost of drugs.
    • “Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) — along with Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) — plan to unveil legislation that would require PBMs, which manage prescription drugs for health insurers, to report a broader range of data about their business practices. The lawmakers seek comment on their proposal.
    • “The bill would require PBMs to submit annual reports to the Medicare drug plans that detail information about the treatments the plan covers, the discounts PBMs negotiate with drugmakers on medicines and the fees they collect.
    • “It’s the latest in a plan from Wyden and Crapo, who released a roadmap in April of PBM-focused legislation they want the committee to pursue.”
  • The Senate Finance Committee adds,
    • “Senate Finance Committee Chair Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) today announced that the committee will mark up legislative proposals to modernize and enhance federal prescription drug programs on Wednesday, July 26th at 2 p.m. The committee package will focus on addressing pharmacy benefit manager practices that have grown increasingly complex and opaque in recent years at the expense of patients and taxpayers.”
  • The American Hospital Association further informs us,
    • “The House Education & Workforce Committee July 12 voted 39-0 to pass legislation (H.R. 4509) that would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and impose civil monetary penalties on hospitals that violate the requirement. * * *
    • “In other action, the committee also passed bills that would strengthen price transparency requirements for commercial group health plans (H.R. 4507); require that the plans’ contracts with service providers allow the employer/plan fiduciary to access all de-identified claims and encounter data (H.R. 4527); and require the plans to further report to the employer/fiduciary their financial arrangements with pharmacy benefit managers (H.R. 4508).”

From the public health front —

  • Beckers Clinical Leadership and Infection Control tells us,
    • “After identifying a new COVID-19 omicron subvariant — EU.1.1, a descendant of XBB.1.5 — in late June, its growth has slowed, according to the CDC. 
    • “Right now, the subvariant accounts for only 1.1 percent of cases in the U.S., data shows. Nationwide, hospitalizations and deaths both continue to decline. The CDC’s most recent data shows that hospitalizations decreased by 0.8 percent as of July 1, and deaths decreased by 9.1 percent in the same one-week period.
  • CNN reports
    • Childhood cancer diagnoses in the US have been trending up for more than a decade, according to a study published Tuesday in the Journal of the National Cancer Institute.
    • There were 14,381 new childhood cancer diagnoses in the US in 2019: about 177 new cases for every 1 million children and teens up to age 19. Incidence rates have dropped since reaching a peak in 2016 but are still about 8% higher than they were in 2003, when there were about 165 new cases for every 1 million children and teens.
    • “Overall, cancer is very rare in children and adolescents, and the increases were small,” said Dr. David Siegel, a pediatric oncologist and an epidemiologist with the US Centers for Disease Control and Prevention’s cancer division who was the lead author of the study. “Past studies have also reported increased survival rates. So the combination of increases in incidence and decreases in deaths means that there are more and more cancer survivors that need long-term care and resources.”
  • The U.S. Census Bureau issued a report examining “Racial/Ethnic Disparities in Disability by Health Condition.”
    • “The data show patterns in health-related disability among adults age 40 and older and key differences by sex, race and Hispanic origin.
      • “Among findings:
      • “Women were more likely than men to have health conditions that limited their daily activities.
      • “Asian (non-Hispanic) adults reported the lowest rates (17.2%) of disability-related health conditions.
      • “Black (non-Hispanic) adults (31.8%) and those reporting Other or multiple-race non-Hispanic identity (42.9%) were among those with higher rates.
  • The All of Us Program released its July 2023 Medical Minutes.

From the Rx coverage front

  • Per Healthcare Dive,
    • Major pharmacy benefits manager CVS Caremark is partnering with drug discounter GoodRx on a joint program to bring down out-of-pocket drug costs, the companies announced Wednesday.
    • Commercially insured customers will be able to pay GoodRx’s discounted pricing when filling commonly prescribed generic prescriptions at in-network pharmacies. The payments will be automatically applied to their deductibles and out-of-pocket limits.
    • The program, called Caremark Cost Saver, will be available for tens of millions of CVS Caremark clients’ members at in-network pharmacies starting January 2024.
  • Per Beckers Payer Issues,
    • ‘About two-thirds of patients who take popular weight loss drugs end their regimen within a year, according to a Prime Therapeutics study released July 11.
    • ‘Prime, a pharmacy benefit manager owned by 19 Blue Cross Blue Shield companies, analyzed pharmacy and medical claims of 4,255 patients who took GLP-1 receptor agonists — such as Ozempic and Wegovy — for weight loss in 2021. The study found only 32 percent of patients continued their weight loss treatment after one year. 
    • “The majority of patients aren’t getting the value of the product and there’s waste, especially with an expensive therapy,” Patrick Gleason, PharmD, Prime’s assistant vice president for health outcomes and a co-author of the analysis, told Reuters. “I was a little bit surprised by the persistency rate.”
  • STAT News delves into how Medicare Advantage plans are approaching the FDA’s approval of the infused Alzheimer’s drug Leqembi. The most illuminating part of the article concerns the Mayo Clinic.
    • As a condition of coverage, Medicare rolled out a new patient registry to collect more information from physicians prescribing Leqembi. Information is supposed to be submitted every six months. Physicians who had previewed the registry said it appeared to function, though many clinics are still finalizing protocols for prescribing Leqembi.
    • “I’m not sure it’s sufficiently detailed to answer the [coverage with evidence development] questions that the [national coverage decision] put forth. We and others would need to collect more detailed information to understand the true benefits and risks of the medicine,” said Ronald Petersen, the director of the Mayo Clinic Alzheimer’s Disease Research Center.
    • Mayo Clinic isn’t prescribing Leqembi yet, as it’s planning to launch an Alzheimer’s treatment clinic in October, Petersen said. He said there has been interest from patients, but it “hasn’t been a landslide.”
    • Petersen is hoping to start a new research study at Mayo Clinic to do more detailed monitoring on patients. To start, Mayo physicians will likely only agree to treat patients in the geographic area close to the facility so they can oversee the follow-up appointments.
    • “We’d be more than happy to share our data with broader communities or merge it with data from CMS. It is incumbent upon all of us to share data to learn from each other what works,” Petersen said.

From the U.S. healthcare business front —

  • MedPage Today points out
    • “Private equity acquisitions of U.S. physician practices have risen dramatically over the last decade, driving up consumer prices in the process, according to a new report.
    • “In 2012, there were 75 private equity deals for physician practices across a range of specialties; in 2021, there were 484, marking a more than six-fold increase, Richard Scheffler, PhD, of the University of California Berkeley, and colleagues found.
    • “Over the entire period, the largest number of deals occurred in dermatology (376), ophthalmology (276), gastroenterology (120), and primary care (118), collectively accounting for 81% of the activity, Scheffler and colleagues wrote in the report, a joint effort by the American Antitrust Institute, the Nicholas C. Petris Center on Health Care Markets and Consumer Welfare at the University of California Berkeley, and the Washington Center for Equitable Growth.”

In telehealth news,

  • Fierce Healthcare tells us,
    • “While payers should cover telehealth, where these services are the most valuable still requires investigation, according to a study in Information Systems Research.
    • “The Centers for Medicare & Medicaid Services made the rules about telehealth usage more flexible during the COVID-19 pandemic, and some lawmakers want to make those changes permanent. But that should not mean giving providers carte blanche approval in using the new technology, nor should payers cover all uses of telehealth, suggests a study by researchers with the University of Texas.
    • “Telehealth should not be regarded as a one-size-fits-all solution to virtualize healthcare,” the study said.
    • “Despite that, however, the study also states that “insurance plans should expand their telehealth coverage to include more providers and close the healthcare access divide in rural locations, which can reduce subsequent hospitalizations and unnecessary costs.”
    • “The authors argue that telehealth’s benefits can be seen in treating conditions and diseases with “high virtualization potential” such as mental health, skin problems, metabolic conditions and musculoskeletal diseases. However, telehealth did not significantly reduce visits to specialists or emergency departments for circulatory, respiratory or infectious diseases.
    • “Indranil Bardhan, Ph.D., one of the authors of the study, said in a press release that “people believed that telehealth would be the next big thing, the future of healthcare. But our research shows that its impact is not as straightforward as people might think. It’s more nuanced.”

Thursday Miscellany

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Wall Street Journal reports
  • STAT News adds
    • “Previous treatments for Alzheimer’s targeted the disease’s symptoms and not the underlying cause of worsening dementia. The debate among physicians is whether that 27% slowing seen with Leqembi is clinically meaningful enough to make the drug, which carries a list price of $26,500 per year, suitable for every patient who might want it.
    • “My general argument is that ‘clinically meaningful’ is personal and specific to a patient and their families, and it’s not something I or any provider can paternalistically determine,” said James Galvin, a neurologist who leads the Comprehensive Center for Brain Health at the University of Miami. “I can’t tell you what’s clinically meaningful to you.”
    • “Eisai’s trial enrolled patients with mild cognitive impairment or early-stage Alzheimer’s who also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. The drug’s label reflects the same narrowed patient population, estimated to encompass approximately 1 million people in the U.S., or just under 20% of those currently living with Alzheimer’s.
    • “In the drug’s prescribing label, the FDA recommends doctors test for a genetic mutation, affecting about 15% of people with Alzheimer’s, that increases the risks of ARIA and reduces the efficacy of Leqembi. The agency also warns doctors to take “additional caution” when considering prescribing to people who are taking blood thinners, which could increase the risk of serious brain bleeds.”
  • Here is a link to the FDA’s press release.
  • In closing, the Wall Street Journal points out
    • Drugmakers and researchers are working on dozens of potential [Alzheimer’s Disease] drugs. Next up for approval is another amyloid-reducing antibody drug, called donanemab, from Eli Lilly. In a small, mid-stage trial, donanemab also modestly slowed the cognitive decline of study subjects compared with placebo.
    • “As of early 2022, there were 143 drugs in clinical trials for Alzheimer’s disease, including 31 drugs in Phase 3, typically the last stage of testing before a drug can be approved, according to a report in Alzheimer’s & Dementia: Translational Research and Clinical Interventions.”
  • Federal News Network reports on OPM’s diminishing yet still excessive backlog of federal retirement claims.
  • Govexec tells us
    • “The Office of Personnel Management last week reminded agencies of the array of workplace flexibilities at their disposal such as leave and telework to help federal workers who have been impacted by natural disasters.
    • “The memo, distributed by OPM Director Kiran Ahuja to heads of federal agencies, corresponds with the start of the annual hurricane season and comes shortly after Typhoon Mawar caused disruptions in Guam and the Northern Mariana Islands, both of which are under U.S. jurisdiction.”

From the public health front —

  • The Associated Press reports
    • “Drinking water from nearly half of U.S. faucets likely contains “forever chemicals” that may cause cancer and other health problems, according to a government study released Wednesday.
    • “The synthetic compounds known collectively as PFAS are contaminating drinking water to varying extents in large cities and small towns — and in private wells and public systems, the U.S. Geological Survey said.
    • “Researchers described the study as the first nationwide effort to test for PFAS in tap water from private sources in addition to regulated ones. It builds on previous scientific findings that the chemicals are widespread, showing up in consumer products as diverse as nonstick pans, food packaging and water-resistant clothing and making their way into water supplies. * * *
    • “The heaviest exposures were in cities and near potential sources of the compounds, particularly in the Eastern Seaboard; Great Lakes and Great Plains urban centers; and Central and Southern California. Many of the tests, mostly in rural areas, found no PFAS.
    • “Based on the data, researchers estimated that at least one form of PFAS could be found in about 45% of tap water samples nationwide.
    • “The study underscores that private well users should have their water tested for PFAS and consider installing filters, said Faber of the Environmental Working Group. Filters containing activated carbon or reverse osmosis membranes can remove the compounds.”
  • The Wall Street Journal informs us
    • A new longitudinal study has examined the medical records of all citizens of Denmark over the age of 16, some 6.5 million people in all, for patterns of diagnosis, hospitalization and treatment for substance use between 1995 and 2021. In the paper, published in the journal JAMA Psychiatry in May, Dr. Oskar Hougaard Jefsen of Aarhus University and colleagues showed that people who had previously been diagnosed with cannabis use disorder were almost twice as likely to be diagnosed later with clinical depression. According to the Centers for Disease Control and Prevention, cannabis use disorder is characterized by craving marijuana, using it more often than intended, spending a lot of time using it, and having it interfere with friends, family and work.
    • Even more dramatically, the paper also found that people with cannabis use disorder were up to four times as likely to be diagnosed later with bipolar disorder with psychotic symptoms. As is true of many psychological disorders, the increased risk was higher in men than in women, and the more a person consumed, the greater the risk. The study did not distinguish between different forms and concentrations of cannabis.
    • Though the association was strong, the authors note that they can’t say for certain whether chronic and heavy cannabis use induces psychosis, or whether people prone to mental illness are more likely to be heavy users. It makes sense that people who feel the symptoms of incapacitating depression or mania, or who sense apparitions or voices only they can hear, might try to self-medicate with cannabis. Without a randomized controlled trial, which would be unethical in the extreme, it’s hard to untangle these strands definitively.
    • But the study is still eye-opening due to its sheer magnitude. With so many people over so many years, there is very little statistical “noise.” And because the information was gathered from the national Danish Health Registry, there were few dropouts—often a big problem in longitudinal studies. As much as possible, the researchers confirmed that the symptoms of a person’s psychiatric disorder emerged after their chronic cannabis use and diagnosis, not before, and that they compared people who were alike in all ways except the frequency of their use.
  • Beckers Hospital Review notes that “In an effort to prevent a repeat of last winter’s “tripledemic” of respiratory illnesses, public health officials are encouraging Americans to get not only a flu shot but also a COVID-19 vaccine and a new vaccine against the respiratory syncytial virus, The New York Times reported July 5.” The FEHBlog thinks that immunity created by the tripledemic will tamp down the viruses this year. Nevertheless, the FEHB plans to get all three vaccines.

From the telehealth and artificial intelligence fronts, we learn from

  • Healthcare Dive that
    • “Nearly one-third of American adults and 40% of adults under 34 report that they would be comfortable with an artificial intelligence-led primary care appointment, according to a new survey released by Outbreaks Near Me and SurveyMonkey.
    • “But the option isn’t their preference. Although survey respondents reported believing that AI in healthcare could reduce medical bias and improve diagnostic accuracy, over 80% of respondents would prefer seeing a human medical professional for prescribing pain medications, deciding when to go to the emergency room and other services.
    • “The latest survey suggests that, while AI hype may be on the upswing, entrenched patient attitudes and preferences for care could be slow to shift.”
  • and
    • “Mental healthcare led telehealth utilization for the sixth straight month in April, representing 68.4% of telehealth claim lines among privately insured patients, according to Fair Health’s April telehealth report.
    • “Although nationwide demand for telehealth services dipped by 5.4% from March to April this year, the percentage of telehealth claims related to mental health services grew for the fourth consecutive month.
  • and
    • “Telehealth patients across most medical specialties are less likely to attend follow-up appointments 90 days after a visit compared to in-person appointments, according to new research from Epic.
    • “The analysis of follow-up visits comes after a December report from Epic found most telehealth patients did not require a follow-up appointment in the three months after an initial visit. Mental health, physical medicine, and rehabilitation and pain medicine had the highest in-person follow-up rates compared to telehealth visits, according to the latest research.
    • “The[se] new telehealth stud[ies] come as federal lawmakers debate whether to make pandemic-era virtual care flexibilities permanent before they expire in 2024.”

From the U.S. healthcare business front

  • Beckers Payer Issues relates
    • “Eli Lilly is now the largest healthcare company in the world by market value, surpassing UnitedHealth Group, Bloomberg reported July 5. 
    • “The pharmaceutical company’s market capitalization surpassed UnitedHealth Group’s July 5 — the first time Eli Lilly has closed above UnitedHealth Group since 2013, according to Bloomberg. 
    • “Eli Lilly’s success is driven by Monjauro, its drug approved for diabetes treatment and expected to receive FDA approval for weight loss, analysts told Bloomberg. The drug is expected to net between $25 and $48 billion in sales once approved.”
  • STAT News tips its cap to Lilly’s leadership David Ricks, 55, Lilly’s CEO, and Daniel Skovronsky, 50, its chief scientific officer.
  • The American Hospital Association offers its two cents on the recent Wall Street Journal article about the state of hospital finances.
  • Fierce Healthcare tells us
    • “Baylor Scott & White Health (BSW) is adding dozens of Texas urgent care clinics to its network thanks to a newly announced deal with NextCare Urgent Care.
    • “Forty-one facilities in “fast-growing areas” such as Houston, San Antonio and Abilene will give the state’s largest nonprofit health system a foothold in new markets. The deal also catapults BSW to a new role as one of Texas’ major providers of urgent care services.
    • “We are dedicated to providing customers with as much choice as possible when seeking care,” Pete McCanna, CEO of BSW, said in a Thursday release from the system. “Through this venture, the NextCare sites across the state will be integrated into our ecosystem of offerings, which already includes 24/7 virtual care available to all Texans via MyBSWHealth.com.”
  • and
    • “Hospital outpatient departments are marking up the prices for biologic medicines more than physician offices, particularly for “innovator biologics” that have clinically equivalent and lower cost alternatives on the market, according to a new analysis from the Employee Benefit Research Institute (EBRI).
    • “These higher charges for these products among hospital outpatient departments (HOPDs) are “roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition,” the independent research group found in its review of a proprietary commercial claims database of 25 million people with private health insurance.
    • “While HOPDs tend to charge higher prices for all medicines relative to the [physician office], higher HOPD markups on biologic medicines are roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition,” Paul Fronstin, director of health benefits research at EBRI, and M. Christopher Roebuck, CEO of health policy research firm RxEconomics, wrote in the brief.”

 

Happy Juneteenth

David Ermer–Congress, Generative AI, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Photo by Derek Lamar on Unsplash

Mercer Consulting offers us this background

  • “On June 19 this year, 96 year-old Opal Lee will once again invite others to join her on a 2.5 mile Walk for Freedom in Fort Worth, Texas. Known as the “Grandmother of Juneteenth,” Opal began campaigning decades ago for a national holiday to commemorate the anniversary of the day in 1865 when news of the Emancipation Proclamation finally reached the enslaved people in Galveston, Texas. In 2016, at age 89, Opal began a symbolic walk from Fort Worth to Washington D.C. in an effort to get 100,000 people to sign a petition to create the holiday. She was transported from city to city where she would walk 2.5 miles, representing the 2.5 years it took for freedom to reach Texas. By the time she made it to Washington, she had obtained over 1.5M signatures. In June 2021, her efforts succeeded – a bill to make Juneteenth a federal holiday was passed by Congress and signed into law by President Joe Biden.  
  • “Juneteenth has long been celebrated by Black people; Opal Lee has vivid memories of celebrating Juneteenth as a child in East Texas with music, food, and games. Since the creation of the federal holiday, more employers are recognizing its importance and embracing their role in promoting Juneteenth in the workplace. In 2021, just 9% of employers had made Juneteenth a paid company holiday. That jumped to 33% in 2022 and rose again this year, to 39%.”

Mercer Consulting adds

  • “For employers, the JAMA Open Network study [on healthcare disparities] underscores the pressing need to expand provider networks to be inclusive of diverse clinicians. By improving networks, and actively working with partners to dismantle barriers and biases within healthcare, we can begin to empower employees with choice – the ability to connect with providers who better understand their unique needs, experiences, and challenges. Diverse physician networks lead to stronger doctor-patient relationships, which ultimately lead to better health outcomes for marginalized populations.”

From Washington, DC —

  • The U.S. Supreme Court handed down five opinions last week. NPR identifies the remaining cases that it is tracking. (One of them the Indian Child Welfare Act was decided last week in favor of the Indian tribes.)
  • Last week, OMB’s Office of Information and Regulatory Affairs posted its Spring 2023 federal regulatory agenda. Here is a link to the OPM agenda. OPM is planning a second Postal Service Health Benefits Program rule and a rule that would accelerate the effective date of FEHB coverage for new federal employees.

Healthcare Dive reports

  • “The group that advises Congress on Medicare policy released a new report Thursday [June 15] with recommendations on telehealth, overpayments to Medicare Advantage plans and site-neutral payments across some outpatient care settings.
  • “The Medicare Payment Advisory Commission, or MedPAC, included telehealth in the report to satisfy a mandate from Congress after virtual care surged during the COVID-19 pandemic. Telehealth coverage under Medicare was limited before the public health emergency, and it was expanded to preserve access to care.
  • “The report found fee-for-service Medicare spending for telehealth care was $4.8 billion in 2020 and $4.1 billion in 2021, more than 30 times greater than 2019. Early findings show more telehealth use was associated with little change in quality, slightly improved access to care for some beneficiaries and slightly increased costs to Medicare.”

From the MD opinion front —

  • An emergency room doctor writing in MedPage Today gives us his take on the fentanyl crisis.
  • An oncologist writing in STAT News gives us her take on the cancer drug shortage. Her article’s title says it all: “Cancer drug shortages should have patients rioting in the streets.”

From the generative AI front, Healthcare IT News tells us, “An NYU Langone Health [large language model] LLM can predict hospital readmissions. The large language model is still in testing, but the AI tool had a median accuracy score of 77.8% compared to a physician score of 62.8%. The code base is now available to all healthcare organizations [via GitHub].

From the semaglutide drug front —

  • The Wall Street Journal reports that these drugs designed for weight loss also may bring alcohol and tobacco use from an addiction to a controllable level.
  • Politico discusses manufacturer lobbying efforts to convince Congress to cover these drugs for weight loss unconnected to diabetes.
  • Bloomberg informs us
    • “Some dosages of Eli Lilly & Co.’s Mounjaro are again in shortage, the latest in a line of recurring supply issues caused by patients using the diabetes medication as a weight-loss treatment.
    • “The latest shortage will result in “intermittent backorders” for three of six doses through July, according to an update posted by the US Food and Drug Administration on its website on Friday.
    • “Lilly spokesperson Jessica Thompson said the backorders were “due to continued dynamic patient demand” and would affect the three highest doses of Mounjaro. She also said the company is investing in expanding manufacturing capacity.”

From the miscellany front –

  • CNBC reports
    • “Bristol Myers Squibb on Friday sued the Biden administration over Medicare’s new powers to slash drug prices, the third such lawsuit to be filed against the program in a matter of days.
    • “The lawsuit filed in federal district court in New Jersey argues the Medicare negotiations violate the First and Fifth Amendments of the U.S. Constitution.
    • “Bristol Myers Squibb has asked the court to declare the program unconstitutional and prevent the Health and Human Services Department from forcing the company to enter negotiations.
    • “Bristol Myers Squibb’s arguments mirror those lodged last week by Merck, the first company to sue the federal government over the drug negotiations. The U.S. Chamber of Commerce has also sued HHS over the program with similar arguments.”
  • Fierce Healthcare relates
    • “Simple HealthKit has inked a deal with Walmart to bring at-home diagnostic tests, including diabetes, respiratory wellness and sexual wellness labs, to the largest retailer in the world.
    • “Through the retail giant’s website, customers can purchase tests bolstered by Simple HealthKit’s end-to-end healthcare infrastructure, including testing, follow-up and treatment. The digital health company’s HbA1c test identifies key markers for Type 2 diabetes. Respiratory wellness tests include influenza A, influenza B and respiratory syncytial virus. In light of a decrease in sexual health testing during the pandemic, customers can test for three of the most common STDs at home, chlamydia, gonorrhea and trichomoniasis.”
  • Health Payer Intelligence points out
    • Employer-sponsored health plan enrollment among nonelderly Americans will grow after 2025, accompanied by higher private payer premiums, a Health Affairs study found.
    • The study used Congressional Budget Office projections to estimate future coverage trends. However, the researchers noted many uncertainties embedded in these trends, including future economic, policy, and healthcare utilization changes. * * *
    • After 2025, enhanced subsidies will end and employment will increase, driving more people to employer-sponsored coverage. Approximately 157 million individuals may have employer-sponsored coverage in 2027. By 2033 this population will grow to 159 million.
    • Private-payer premiums will also trend upward from 2023 through 2033. In 2023, the private payer premium growth rate will be 6.5 percent. Premiums will grow 5.9 percent from 2024 to 2025 and 5.7 percent from 2026 to 2027. By 2033, the average premium increase will be 4.6 percent.
  • Of course, depending on the outcome of the 2024 federal election, it is possible that the ACA subsidies could be made permanent in 2025. Time will tell.

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Medicare, Rx coverage, Telehealth–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Senate Finance Committee held a hearing today about “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs.”
  • Mercer Consulting informs us
    • “Two key House committees voted this week to send a series of health care bills to the House floor, including legislation to make permanent the ability of health savings account-qualifying high-deductible health plans (HSA-qualifying HDHPs) to cover telehealth and other remote care services on a predeductible basis. Originally enacted as part of the 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act, this flexibility was most recently extended as part of the 2023 Consolidated Appropriations Act, and now is set to expire on Dec. 31, 2024, for calendar-year plans (later for noncalendar-year plans).”
  • “The U.S. Department of Health and Human Services (HHS) released the STI Federal Implementation Plan to detail how various agencies and departments across the federal government are taking a comprehensive approach to making meaningful and substantive progress in improving public health. This new plan builds on other key HHS actions to protect the public’s health by addressing the growing threat of sexually transmitted infections (STIs) in America.”
    • Roll Call identifies potential obstacles to implementing this plan.
  • Govexec reports
    • “As smoke from Canadian wildfires moves into the Northeast and Mid-Atlantic regions of the United States, triggering air quality warnings in several cities, the Office of Personnel Management on Thursday reminded agencies to protect the health of federal workers who ordinarily may work or commute to work amid the hazardous haze.”
      • Healthcare Dive discusses health system reactions to this problem.
        • “Hospitals in the northeastern U.S. are keeping an eye on air quality as smoke from Canadian wildfires envelops the region. Most health systems contacted by Healthcare Dive did not report significant spikes in patient volumes yet, but they said they’re continuing to monitor the situation.
        • “Millions of people live in areas currently under air quality alerts, and meteorologists say conditions may not significantly improve for a few more days.
        • “Health systems in the region are urging residents to stay indoors and use masks — particularly snug-fitting N95s — when traveling outside. Though everyone should limit their time outdoors, it’s especially important for older people, children and pregnant women as well as those with conditions like heart or lung disease or asthma, according to Kristin Fless, a pulmonologist at RWJBarnabas Health Medical Group.”
  • The Wall Street Journal relates
    • “Ashish Jha, the White House Covid-19 czar, will be leaving his post next week in the latest sign the Biden administration is confident the country is on stronger footing in its fight against the virus.
    • “Jha plans to leave June 15 and return July 1 to his previous position as dean of Brown University’s School of Public Health. He will be the last of the administration’s rotating Covid-19 czars. Instead, the director of the White House’s nascent Office of Pandemic Preparedness and Response Policy, who hasn’t been named, will advise the president and coordinate federal responses to various biological and pandemic threats.”

From the  public health front —

  • Mercer Consulting tells us
    • Our research over the past few years has tracked the ways employers are working to align employee benefit programs with their organizations’ overarching DEI goals. For Pride month, here’s a round-up of survey results relating to health and well-being benefits of particular importance to the LGBTQ+ community.
    • Here’s a link to the article.
  • The American Hospital Association reports
    • “The first data on the safety of a third mRNA COVID-19 vaccine dose among young children show that a third dose is safe for children ages 6 months to 5 years old, similar to findings for doses one and two, the Centers for Disease Control and Prevention reportedtoday, based on reports to the Vaccine Adverse Event Reporting System and v-safe voluntary smartphone health checker for use after vaccination.
    • “This study’s findings can reassure health care professionals, parents, and caregivers that a third dose of COVID-19 vaccine is safe for children ages 6 months to 5 years and can protect them from severe illness,” CDC said.
    • “While CDC recommends that all children ages 6 months through 5 years old receive at least 1 bivalent mRNA COVID-19 vaccine dose, vaccination rates among this age group have been low.”
  • Health Payer Intelligence informs us
    • “Group health insurance plan members with high healthcare spending often have one or more of the same five chronic diseases, according to a fast facts sheet from the EBRI Center for Research on Health Benefits Innovation (EBRI CRHBI).
    • “The study covered healthcare claims from 8.6 million group insurance health plan members using 2021 data from the Merative MarketScan Commercial Database. Members were 65 years of age or younger and the health plans covered a variety of types.
    • “Five conditions were very common among the group health insurance plan members with the highest healthcare spending: heart disease, respiratory conditions, musculoskeletal conditions, nervous system conditions, and skin disorders. A couple of these are among the most expensive chronic diseases in the US. They are also some of the most common comorbidities.”

From the Rx coverage front —

  • BioPharma Dive notes that tomorrow a Food and Drug Administration advisory committee will consider recommending that the FDA give full marketing approval to the Alzheimer’s drug Leqembi.
    • “A closely watched Alzheimer’s disease medicine appears to be heading toward broader approval, as documents released Wednesday show the Food and Drug Administration appears to have few concerns with it.”
  • BioPharm Dive also tells us that “After years of disappointment, cancer vaccines show new promise. Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.”
    • “Moderna is testing its shot, mRNA-4157, together with Merck’s immunotherapy Keytruda in people with melanoma who have had their primary tumors removed. The goal of such “adjuvant” treatment is to prevent cancer from returning.
    • “In December, the company reported the two drugs reduced the relative risk of death or recurrence by 44% over Keytruda alone. The new data came from an analysis of the risk of cancer spreading to distant organs or tissues, or “distant metastasis free survival.”
    • “One-third of patients who receive Keytruda in this setting experience such spread, driving researchers’ work to come up with better options. “We know that patients with distant metastases experience more morbidity and mortality,” said Adnan Khattak, a clinical professor at Edith Cowan University in Australia, who presented the Moderna data at ASCO.
    • “In the combination trial, mRNA-4157 and Keytruda reduced the risk of distant spread or death by 65% compared to Keytruda alone.”
  • The Associated Press reports
    • “A growing shortage of common cancer treatments is forcing doctors to switch medications and delaying some care, prominent U.S. cancer centers say.
    • “The National Comprehensive Cancer Network said Wednesday that nearly all the centers it surveyed late last month were dealing with shortages of carboplatin and cisplatin, a pair of drugs used to treat a range of cancers. Some are no longer able to treat patients receiving carboplatin at the intended dose or schedule. 
    • “Dr. Kari Wisinski has had to turn to other treatments for some patients or switch the order in which people receive their drug combinations. She said she’s done that “hoping that within three months there will be a better carboplatin supply.” * * *
    • “The U.S. Food and Drug Administration has taken some steps to try to ease the chemotherapy shortage. The agency is allowing the temporary importation of some foreign-approved versions of cisplatin from factories registered with the FDA.”
  • Beckers Hospital Review adds “Seventy percent of the 20 most commonly prescribed medications from GoodRx are in shortage, according to databases from the FDA and the American Society of Health-System Pharmacists.” The article goes on to list the drugs subject to shortages.

From the Medicare front —

  • Beckers Payer Issues informs us
    • “The FDA and CMS are discussing how to handle obesity drugs in Medicare, Bloomberg Law reported June 7. 
    • “The two agencies are in talks over “what to do about obesity drugs,” FDA Commissioner Robert Califf said at the Biotechnology Innovation Organization convention in Boston. Mr. Califf’s comments indicate CMS could expand weight loss benefits, according to Bloomberg Law’s report. 
    • “New GLP-1 drugs to treat obesity and diabetes can be expensive, costing upward of $10,000 a year without insurance coverage. GLP-1 drugs, including Ozempic, Trulicity, Victoza and Mounjaro, are used to treat Type 2 diabetes. Wegovy and Saxenda are approved for weight loss.  
    • “Under current law, Medicare is prohibited from covering weight loss drugs. Drug manufacturers are lobbying Congress to require the program to pay for the drugs. Proposed legislation to pay for the drugs has stalled. 
    • “The drugs could have a big effect on Medicare Part D spending. If 10 percent of people with obesity covered by Medicare were prescribed a brand-name semaglutide, a type of GLP-1, the drug would cost Medicare $26.8 billion annually, according to a study published in the New England Journal of Medicine in March.”
  • and
    • “Medicare spending per person grew by an average of 4.6 percent annually between 2000 and 2022, according to a June 6 analysis from KFF. 
    • “KFF analyzed data from the 2023 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. 
    • “KFF said the “influx of the Baby Boomer Generation added many relatively younger, healthier people to the Medicare beginning in 2011,” while the share of adults aged 80 and older enrolled in the program also continues to grow. Growth in healthcare spending is attributed to this increased volume and use of services, along with the availability of new technologies and rising prices.”
      • 2018: $13,579
      • 2019: $14,189
      • 2020: $14,373
      • 2021: $15,139
      • 2022: $15,727

Friday Factoids

David Ermer–Congress, COVID treatment, FDA, Federal employment benefits, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC

  • The Wall Street Journal reports
    • “President Biden said negotiators were closing in on a deal to cut spending and raise the $31.4 trillion debt limit, seeking to overcome final hurdles on issues regarding the budget as well as requiring more people to work to receive federal benefits.
    • “He said talks are “very close” to reaching an agreement and that he was hopeful that there could be a breakthrough as soon as later on Friday. “I hope we’ll have some clear evidence tonight, before the clock strikes 12, that we have a deal,” he said as he departed the White House for Camp David on Friday evening.
    • “Negotiators are hoping to strike a deal soon in order to set up votes on the legislation next week. The Treasury Department, which is currently using extraordinary measures to avoid exceeding the debt ceiling, estimated Friday that the government could run out of money to pay its bills if Congress doesn’t act by June 5.
    • “Treasury had previously put the deadline as early June, saying it could come as soon as June 1. Any legislation would likely take at least several days to pass both the House and Senate.
  • Govexec tells us
    • “The federal government’s HR agency on Wednesday unveiled new guidance aimed at standardizing and revitalizing employee assistance programs across the federal government, an effort officials said would prioritize employee wellness and improve productivity.
    • “Like many private sector employers, federal agencies often offer employees access to employee assistance programs, which provide services related to maintaining one’s mental and physical health, as well as resources related to substance use issues.
    • “The Office of Personnel Management, spurred by a provision of President Biden’s management agenda tasking agencies with promoting “awareness of employee well-being and [supporting] initiatives that extend beyond the workplace,” underwent a year-long effort to design a “standardized approach” to employee wellness programs, consulting with focus groups, health experts and vendors who provide assistance programs to employers.
    • “The result is a 19-page guidance document for agencies to reassess their assistance program offerings and, if necessary, expand them.
  • The FEHBlog wonders why OPM silos its various benefit programs rather than integrate them to get more bang for the buck.

From the healthcare costs front —

  • Milliman has released its 2023 Medical Index. Milliman estimates the healthcare cost for a hypothetical family of four enrolled in a hypothetical PPO plan is $31,065, a 5.6% increase over 2022.
  • The Medical Group Management Association issued its 2023 Physician Compensation and Productivity Benchmarks.
    • “Productivity remained relatively flat or only slightly increased relative to pre-pandemic benchmarks, with the biggest change in work RVUs posted in dermatology, hematology/oncology, and family medicine (without OB). 
    • “The growth in median total compensation for primary care physicians (PCPs) doubled from 2021 (2.13%) to 2022 (4.41%), but was outpaced by inflation at 7% and 6.5%, respectively. 
    • “Surgical and nonsurgical specialists saw their change in median total compensation cool slightly in 2022, dropping from 3.89% for surgical specialists in 2021 to 2.54% in 2022, and from 3.12% for nonsurgical physicians in 2021 to 2.36% in 2022. 
    • “APPs [advanced practice providers]— who saw the biggest change in median total compensation from pre-pandemic levels — saw their 2022 growth ebb slightly to 3.70%, down from 3.98% growth in 2021.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review points out
    • “There are 293 rural hospitals at immediate risk of closure due to inflation, staffing shortages and other financial stress, according to the Center for Healthcare Quality & Payment Reform. 
    • “Hospitals at immediate risk of closure have lost money on patient services for multiple years, excluding 2020 during the pandemic, and aren’t likely to receive sufficient funds to cover the losses with public assistance ending, according to the report. These hospitals also have low reserves and more debt than assets.”
  • MedCity News relates
    • “The pandemic prompted a great need for technology-enabled care delivery, so the regulations surrounding reimbursement for these services were tossed out the window in 2020. Now that the public health emergency has ended, the healthcare industry has to figure out how it is going to pay for digital health services going forward.
    • “It’s clear that services like telehealth and remote patient monitoring have potential to provide value, but hospitals and digital health companies need to show payers clearer evidence of the outcomes these care modalities can produce, panelists argued during a Wednesday session at MedCity News’ INVEST conference in Chicago.” 
  • STAT News adds market perspective on the Food and Drug Administration’s full approval of Paxlovid, announced yesterday.
    • “The full approval for treating adults at high risk of progression to severe disease will help Pfizer expand its marketing campaign. U.S. officials plan to work through much of the government’s Paxlovid inventory, which is available for free at pharmacies around the country, before moving to a normal commercial market for the drug. Pfizer has sold the U.S. government nearly 24 million courses at around $530 a course, but it is not clear yet what price the company will charge.”

From the interoperability front —

  • The Pharmacy Times tells us
    • “Integrating Immunization Information Systems (IIS) vaccination records into claims data (collected by health insurers) increased the number of people identified as being vaccinated against COVID-19, according to the results of a study published in JAMA Network Open. Having accurate COVID-19 vaccination data is important for future COVID-19 vaccine studies that capture efficacy and safety, according to the study.
    • “When claims data were supplemented with IIS vaccination records, the proportion of participants with at least one vaccine dose rose from 32.8% to 48.1%. And when IIS vaccine records were included with claims data, the percentage of people who completed a vaccine series increased from 24.4% to 41.9%, varying by state.”
  • Per FCW
    • The Food and Drug Administration is looking to develop standardized “supersets of data” and improve data interoperability, analysis and management across the agency, an official said on Wednesday. 
    • The agency is planning to gather information and seek public input on the use of real-world data in its decision-making processes, according to Jose Galvez, deputy director for the office of strategic programs of the FDA’s Center for Drug Evaluation and Research. 
    • Galvez said at the Professional Services Council 2023 FedHealth Summit that the FDA is set to release a Federal Register notice “very shortly” to gain industry input on evaluating new types of data analysis.

Midweek Update

David Ermer–Congress, End of the PHE, NE, NCQA, NIH, OPM, Rx coverage, Telehealth, Uncategorized–
Photo by Michele Orallo on Unsplash

From Capitol Hill —

Roll Call reports

  • “The White House and congressional leaders are discussing the duration of appropriations caps and a debt limit raise as staff talks get underway in advance of the next principals meeting on Friday.
  • “A two-year appropriations deal is under consideration, according to sources familiar with the talks, along the lines of three separate laws since 2015 that were paired with suspensions of the debt limit. 
  • “The White House and top Democrats are pushing for two years of debt limit breathing room, as in the 2019 deal cut with former President Donald Trump. That law contained two years of spending caps, which Speaker Kevin McCarthy pointed out as far back as January.
  • “Such an arrangement would, in theory, remove the threat of fiscal cliffs facing lawmakers and the economy until after the 2024 elections.”

Fierce Healthcare tells us,

  • “The Senate Health, Education, Labor and Pensions (HELP) Committee convened the heads of three big pharmas—Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jørgensen and Sanofi CEO Paul Hudson—as well as the top brass at the three largest PBMs—CVS Health Executive Vice President and President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.
  • “The legislation on the docket for the HELP Committee aims to inject transparency into the pharmaceutical supply chain as well as increase access to generics. PBM reforms on the table include eliminating spread pricing models as well as clawbacks from pharmacies. * * *
  • “The HELP Committee will convene Thursday to mark up four bills that target drug pricing. Sanders said that while these measures are a priority, there’s more work to be done in addressing this issue. He added that issues with affording drugs are a broader part of the ongoing challenges around affordability in healthcare.”

Tomorrow is the last day of the Covid public health emergency, and today the Department of Health and Human Services posted a fact sheet on how the end of the PHE affects telehealth.

From the Rx coverage front, the Wall Street Journal points out

  • “Advisers to the Food and Drug Administration recommended making an oral contraceptive available without a prescription for the first time, potentially widening access to birth control for women across the country. 
  • “The panel of FDA advisers voted 17 to 0 on Wednesday that there was enough evidence for the agency to approve the medication’s sale over-the-counter. The FDA, which is expected to make a final decision this summer, doesn’t have to follow the expert panel’s advice, though it often does.
  • “The FDA approved the pill, called Opill, for prescription use in 1973. HRA Pharma, owned by Perrigo, a Dublin-based generic drugmaker, submitted its application to make Opill available over-the-counter last July. 
  • “The advisory panel said the benefits of making oral contraceptives available over-the-counter outweighed the risks.”

The cost curve is pointing down.

From the medical research front, the National Institutes of Health updates us on multiple mRNA vaccines that show promise for treating HPV-Related cancers.

From the healthcare quality front, NCQA informs us

  • “We launched our Race and Ethnicity Stratification Learning Network.
  • “The network is a free, interactive, online tool that offers data and best practices to help health plans improve how they collect race and ethnicity data on enrollees.
  • Improving data collection of race and ethnicity data is vital to improving health equity.
  • “The data available in this new resource summarize the care of 20 million people enrolled in 14 health plans that reported results on 5 HEDIS measures, stratified by race and ethnicity.
  • “Best practices we identify come from NCQA’s qualitative interviews of key staff at plans in the learning network.
  • “A report groups our findings in three areas.”

Check it out.

From the federal employment front, the Office of Personnel Management announced

  • released proposed regulations that would prohibit the use of previous salary history in setting pay for federal employment offers. Under the new proposed regulations, federal agencies would not be able to consider an applicant’s salary history when setting pay for new federal employees in the General Schedule pay system, Prevailing Rate pay system, Administrative Appeals Judge pay system, and Administrative Law Judge pay system.  
  • “These proposed regulations are a major step forward that will help make the federal government a national leader in pay equity,” said OPM Director Kiran Ahuja. “Relying on a candidate’s previous salary history can exacerbate preexisting inequality and disproportionally impact women and workers of color. With these proposed regulations, the Biden-Harris Administration is setting the standard and demonstrating to the nation that we mean business when it comes to equality, fairness, and attracting the best talent.”