End of Week Update

U.S. Healthcare

End of Week Update

David Ermer–Congress, FDA, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC

  • Roll Call offers the history of the August Congressional recess, which began on Thursday. The recess gives the staff time to prepare for the big September legislative push.
  • Roll Call adds
    • “Days after it was passed by the House, the Senate cleared legislation Thursday evening that aims to overhaul the organ transplant system in the United States.
    • “The bill now goes to President Joe Biden’s desk for his signature.
    • “The bill would give the Department of Health and Human Services the authority to expand competition for contracts related to the operation of the Organ Procurement and Transplantation Network, which matches donor organs with patients waiting for transplants.
    • “The legislation comes as the Biden administration moves to open up the contracting process that has allowed one company to manage the system for nearly 40 years, despite claims of mismanagement that has allowed patients to die on waiting lists.
    • “The management of the U.S. organ transplant system needs serious reform,” said Sen. Bill Cassidy, R-La., a co-sponsor of the Senate companion version of the bill and the ranking member of the Senate Health, Education, Labor and Pensions Committee. “Breaking up this monopoly will increase competition, save lives and improve the system. Glad to see our legislation pass Congress and look forward to it becoming law.”
  • NBC News and STAT News let us know that both Houses of Congress are preparing legislation to hopefully solve the Nation’s widespread drug shortage.
  • AHA News adds,
    • “In the wake of tornado damage last week to a large Pfizer sterile injectables plant in North Carolina, the Food and Drug Administration July 28 posted a list of products made at the facility that have less than three months of inventory in the supply chain. According to Pfizer, there does not appear to be any major damage to production areas at the 250-acre site, but about 40,000 pallets of supplies and finished goods stored in the facility’s high-rise warehouse were damaged. The company said it is working to restart production and explore alternative manufacturing locations and will update the information as it learns more. Meanwhile, the company said it is allocating products in its hospital portfolio.”
  • Also, per AHA News
    • “The Centers for Medicare & Medicaid Services July 28 issued its final rule updating hospice payments for fiscal year 2024. CMS finalized a 3.1% ($780 million) net increase to FY 2024 payments as compared with FY 2023. This update includes a 3.3% market basket, reduced by a 0.2% productivity adjustment.”
  • The Food and Drug Administration approved
    • “RiVive, 3 milligrams (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose. This is the second nonprescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription. The timeline for availability and the price of this nonprescription product will be determined by the manufacturer.”

From the U.S. healthcare business front —

  • Beckers Payer Issues informs us that health insurer “Centene recorded $1.06 billion in net income in the second quarter of 2023 after recording a $172 million loss over the same period last year, according to the company’s earnings report released July 28.”
  • BioPharma Dive reports
    • “Biogen is making one of the biggest business bets in its 45-year history, announcing Friday a deal to buy Reata Pharmaceuticals and its newly approved rare disease drug for approximately $7.3 billion.
    • “The Cambridge, Massachusetts-based biotechnology company will pay $172.50 per Reata share, which represents a premium of about 59% over the stock’s closing price Thursday. Biogen expects to fund the deal with cash on hand as well as additional debt.
    • “Acquiring Reata gives Biogen access to Skyclarys, a drug for the neuromuscular condition Friedreich’s ataxia that gained U.S. approval in March. The disease is uncommon, affecting an estimated 5,000 people in the U.S. And its clearance was controversial, following years of back-and-forth with the Food and Drug Administration.”
  • and
    • “AstraZeneca has reached a deal to acquire a group of early-stage gene therapy programs and related technologies from Pfizer, the British drugmaker’s most significant move to date in the field of genetic medicine.
    • “Per deal terms, AstraZeneca’s rare disease division Alexion will pay up to $1 billion to acquire the programs and novel “capsids,” the protein shells that protect gene therapies as they’re delivered into the body. AstraZeneca intends to use those capsids to develop genetic therapies with “improved safety and efficacy profiles,” the company said Friday.
    • “AstraZeneca will pay royalties on sales of any commercial products that arise from the deal. Alexion also intends to “welcome talent from Pfizer” who were working on the research, an area the drugmaker has cut back on in favor of more advanced gene therapy programs.”
  • Per BNA News,
    • “Employer-sponsored health plans are investigating the possibility of organizing risk pools to help finance the high cost of prescription drugs.
    • “They are eyeing asking for government help in setting up risk pools that would help cover costs for so-called orphan drugs that treat rare diseases, as well as for high-cost gene and cell therapies. Risk pools are funds collected from groups of employers that would be used to pay for high-cost drugs.
    • “Employers are particularly worried about high-cost drugs that can run more than $1 million. Even with stop-loss insurance, which covers high claims costs, employers can end up footing the bill after a drug is covered the first year.”

Thursday Miscellany

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

From Washington DC —

  • Roll Call reports
    • “[T]he monthlong August recess [which the House began this afternoon] virtually ensures there is no longer enough time to complete fiscal 2024 appropriations by Oct. 1, given that the full Senate has yet to take up any of its bills and the House passed only one.
    • “The Senate now has only four weeks in September to make headway on appropriations, and the House is scheduled to be in session only 12 days that month unless plans change.
    • “Speaker Kevin McCarthy, R-Calif., and Senate Majority Leader Charles E. Schumer, D-N.Y., met Thursday to discuss the appropriations process. McCarthy said he asked Schumer to “get into conference early before Sept. 30 so we can try to get this done.”
  • The American Hospital Association informs us,
    • “The Senate Appropriations Committee today voted 26-2 to approve legislation that would provide $224.4 billion in funding for the departments of Labor, Health and Human Services, and Education in fiscal year 2024, a 7% cut below the prior fiscal year.”
    • “The Centers for Medicare & Medicaid Services today released its fiscal year 2024 Inpatient Rehabilitation Facility Prospective Payment System final rule. The rule increases payments by an estimated 4%, or $355 million, in FY 2024 relative to 2023.”
    • The Centers for Medicare & Medicaid Services today released its fiscal year 2024 final rule for the inpatient psychiatric facility prospective payment system, which updates the IPF payment rate by a net 2.4% in FY 2024.”
    • “The AHA today joined AHIP, the American Medical Association, and Blue Cross Blue Shield Association in urging the Centers for Medicare & Medicaid Services not to implement its proposed HIPAA prior authorization standards for claims attachments due to conflicting regulatory proposals, which “would create the very same costly burdens” that administrative simplification seeks to alleviate.”
      • The last item surprised the FEHBlog.
  • STAT News tells us
    • “To narrow the nation’s deeply entrenched health disparities, a permanent entity with regulatory powers should be created by the president to oversee health equity efforts across the entire federal government, says a report issued Thursday by the National Academies of Science, Engineering, and Medicine.
    • “In its many recommendations, the committee that wrote the report called for Congress to create a scorecard to assess how new federal legislation might affect health equity; urged all federal agencies to conduct an equity audit of current policies; asked the Centers for Disease Control and Prevention to create and facilitate the widespread use of measurements of social determinants of health, including racism; and urged the Office of Management and Budget to oversee efforts to improve the poor and sporadic collection of data about the nation’s racial and ethnic groups.”

From the public health front —

  • The New York Times lets us know,
    • “A new analysis of data from a large clinical trial of healthy older adults found higher rates of brain bleeding among those who took daily low-dose aspirin and no significant protection against stroke.
    • “The analysis, published Wednesday in the medical journal JAMA, is the latest evidence that low-dose aspirin, which slows the clotting action of platelets, may not be appropriate for people who do not have any history of heart conditions or warning signs of stroke. Older people prone to falls, which can cause brain bleeds, should be particularly cautious about taking aspirin, the findings suggest.
    • “The new data supports the recommendation of the U.S. Preventive Services Task Force, finalized last year, that low-dose aspirin should not be prescribed for preventing a first heart attack or stroke in healthy older adults.
    • “We can be very emphatic that healthy people who are not on aspirin and do not have multiple risk factors should not be starting it now,” said Dr. Randall Stafford, a medical professor and epidemiologist at Stanford University.”
  • The Wall Street Journal relates,
    • “To reduce your cancer risk, you don’t need to make it all the way to the gym: You could start by bringing in the groceries. 
    • “People who recorded just under four minutes of vigorous movement every day had a roughly 17% reduced cancer risk compared with people who didn’t log any high-intensity movement, a study published Thursday in the journal JAMA Oncology concluded. The link was stronger for cancers in which exercise has previously been connected to lower risks, including breast, colon, endometrial and bladder cancer. 
    • “The study followed more than 22,000 people who reported that they didn’t exercise but logged minute-long bursts of activity such as walking uphill or carrying shopping bags. It adds to evidence connecting physical activity to better health, even when the movement is modest.
    • “Short bursts of vigorous activity are clearly important for cancer risk at the population level,” said Elizabeth Salerno, a biobehavioral scientist at the Siteman Cancer Center at Washington University in St. Louis, who wasn’t involved in the research. “It’s never too late to get moving in small ways, whether that be parking farther away at the store or taking the stairs.”

Following up on FEHBlog posts from earlier this week —

  • Becker’s Hospital Review identifies “[t]hirteen essential drugs made at Pfizer’s Rocky Mount, N.C., facility — which was recently damaged by a tornado — have a vulnerability score higher than 90 percent, according to a July 26 report from United States Pharmacopeia. 
  • Becker’s Payer Issues offers an overview of Cigna’s defense to “a lawsuit in California that accuses the payer of denying large batches of members’ claims without individual review, thereby denying them coverage for certain services.”

From the U.S. healthcare business front —

  • Healthcare Dive points out,
    • “HCA Healthcare beat Wall Street expectations in the second quarter and raised its full-year outlook off of increases in admissions, emergency room visits and surgeries, as more patients returned to hospitals for care.
    • “HCA, the largest for-profit hospital operator in the country, reported revenue of $15.9 billion in results released Thursday, up from $14.8 billion in the second quarter of 2022. 
    • “HCA’s results were solid, but below elevated investor expectations, analysts commented. That led HCA’s stock to fall 3% in Thursday morning trade following the earnings release.
    • “The Nashville, Tennessee-based operator saw demand for services increase broadly in the second quarter.
    • “Admissions, emergency room visits, inpatient surgeries and outpatient surgeries were up 2.2%, 3.7%, 1.8% and 3.3%, respectively, on a year-over-year basis.”
  • MedCity News tells us,
    • “More than 600 rural U.S. hospitals are at risk of closing due to their financial instability — that’s more than 30% of the country’s rural hospitals. For half of these 600 hospitals, the risk of closure is immediate, according to a new report from the Center for Healthcare Quality and Payment Reform (CHQPR).
    • “All states have rural hospitals that are at risk of closing except for five: Delaware, Maryland, New Jersey, Rhode Island and Utah. In over half of all U.S. states, a quarter or more of rural hospitals are at risk of closure. In 16 states, 40% or more are at risk.”
  • MPRNews reports,
    • “Sanford Health and Fairview Health Services said Thursday they are dropping plans to merge, a proposal that would have created a health care system giant in the Upper Midwest.
    • “A spokesperson with Sanford Health said Sanford’s board of trustees made the decision to stop the process at a noon meeting Thursday and informed Fairview CEO James Hereford a few hours later.” 
  • Fierce Healthcare notes
    • “Hello Alpha, a virtual primary care platform, has launched a weight management program for employers that supports sustained weight loss through the lens of whole-person primary care.
    • “The program, Ahead with Alpha, treats and screens for health needs by combining weight loss support with care for more than 100 other medical conditions. The approach combines cost-saving benefits with rapidly-evolving innovations in obesity medicine, the company said.
    • “Members in the program also receive weight loss support like medication management, nutrition counseling with a registered dietitian and progress tracking. And, the program will migrate patients who have successfully lost weight into a lower-cost maintenance program.
    • “Hello Alpha has treated more than 50,000 patients with excess weight and, on average, they experience a sustained 15% reduction in body mass index after 10 or more months in the program, executives said in a press release. That experience has endowed Hello Alpha with expertise in prior authorization, step therapy and formulary management, they said. 
    • “Health can’t be measured in just one metric, as many point solutions claim,” Gloria Lau, Hello Alpha’s co-founder and CEO, said in a press release. “These fragmented solutions that focus on only one aspect of health are creating point-solution fatigue and skepticism. Employers are questioning if these siloed programs deliver real ROI.”

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.”

Monday Roundup

David Ermer–FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • OPM has finalized a rule
    • “to expand eligibility for enrollment in the Federal Employees Dental and Vision Insurance Program (FEDVIP) to additional categories of Federal employees and certain Postal employees. This rule also updates the provisions on enrollment for active duty service members who become eligible for FEDVIP as uniformed service retirees pursuant to the National Defense Authorization Act of 2017 (fiscal year 2017 (FY17) NDAA). In addition, this rule adds exceptions to decrease an enrollment type and to cancel an enrollment for certain enrollees who may become eligible for dental and/or vision services from the Department of Veterans Affairs (VA).” 
  • Per Medscape, the Food and Drug Administration
    • “today approved quizartinib (Vanflyta) for adults with acute myeloid leukemia (AML) that carries the FLT3-ITD genetic mutation.
    • “The FDA also approved the LeukoStrat CDx FLT3 Mutation Assay to determine whether patients have this mutation.
    • “The agency granted quizartinib a first-line indication for use in combination with standard chemotherapy — cytarabine and anthracycline induction followed by cytarabine consolidation — and as maintenance monotherapy afterward, in adults whose tumors express FLT3-ITD.” * * *
    • “In a company press release, the drug’s manufacturer Daiichi Sankyo said quizartinib will be available in the US soon.”
  • Per Fierce Healthcare, the Federal Trade Commission expanded its war on prescription benefit managers by withdrawing earlier guidance that protected PBMs.

Speaking of war, STAT News reports

  • “A new lawsuit accuses Cigna of using an algorithm to automatically deny claims in bulk instead of individually reviewing each case, putting patients on the hook for bills the health insurer otherwise would have paid.
  • “The complaint filed Monday in the Eastern District of California says Cigna uses a system called PXDX to identify discrepancies between diagnoses and the tests and services it covers for those ailments. The company then allegedly denies claims in bulk without looking into each coverage request. California law requires insurers to give each claim a “thorough, fair, and objective investigation.”

For the past twenty years, health claims have been submitted and processed electronically. This is nothing new. The article adds that Cigna plans to mount a defense. The FEHBlog trusts that the court will see the light.

From the public health front,

  • MedPage Today tells us
    • “The prevalence of hepatitis C virus (HCV) infections in pregnant women increased 16-fold over a 21-year period, with associated higher risks of adverse perinatal outcomes, according to a cross-sectional study.
    • “Among more than 70 million hospital admissions for childbirth or spontaneous abortion in the U.S. from 1998 through 2018, the prevalence of HCV-positive pregnancies increased from 0.34 (95% CI 0.26-0.41) cases per 1,000 pregnancies to 5.3 (95% CI 4.9-5.7) cases per 1,000 pregnancies, reported Po-Hung (Victor) Chen, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, and colleagues in JAMA Network Open. * * *
    • “Overall, our data support the recommendations for universal HCV screening with each pregnancy proposed by the Centers for Disease Control and Prevention and American College of Obstetricians and Gynecologists,” Chen and team wrote. “Perinatal care and delivery may be the initial healthcare exposure for many women. These touchpoints represent an opportunity for health care professionals to identify HCV infection and link women and their children to appropriate specialist care.”

In medical and drug research news

  • The National Institutes of Health announced,
    • “Statins, a class of cholesterol-lowering medications, may offset the high risk of cardiovascular disease in people living with HIV by more than a third, potentially preventing one in five major cardiovascular events or premature deaths in this population. People living with HIV can have a 50-100% increased risk for cardiovascular disease. The findings are published in the New England Journal of Medicine.
    • “This research suggests that statins may provide an accessible, cost-effective measure to improve the cardiovascular health and quality of life for people living with HIV,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), a study funder. “Additional research can further expand on this effect while providing a roadmap to rapidly translate research findings into clinical practice.”
  • BioPharma Dive reports
    • “Roche will partner with Alnylam Pharmaceuticals to study a promising new treatment for high blood pressure, becoming the latest large drugmaker to commit in a big way to the often lengthy and expensive process of developing new medicines for the heart. 
    • “Through a deal announced Monday, Roche will pay Alnylam more than $300 million upfront to share rights to the experimental treatment, called zilebesiran. The Swiss pharmaceutical company will also fund the majority of the costs for a large clinical trial to test whether zilebesiran can lower the risk of dangerous cardiovascular events like heart attacks and strokes. 
    • “With this collaboration, we now can develop zilebesiran in a more robust way, allowing us to have cardiovascular outcomes data in hand at launch to ensure results relevant not only for health authorities but also for access and clinical practice in order to ultimately reach as many patients as possible,” Alnylam CEO Yvonne Greenstreet said in a statement.” 
  • BioPharma Dive adds
    • “Gilead Sciences has stopped a closely watched trial involving an experimental cancer drug the company acquired three years ago in a roughly $5 billion deal, marking the latest setback in the company’s plans to grow its oncology business.
    • “According to Gilead, a Phase 3 study testing its drug magrolimab in patients with the bone marrow cancer myelodysplastic syndrome, or MDS, was discontinued because treatment proved ineffective at an interim analysis. Safety findings were “consistent” with the drug’s profile and what’s typically observed with MDS patients, the company said late Friday. It didn’t provide details.
    • “Gilead acquired magrolimab through a buyout of biotechnology company Forty Seven. The drug is still being evaluated in two other pivotal trials in acute myeloid leukemia, with results expected next year. However, after Friday’s announcement, Wall Street analysts appear to be viewing those trials with more skepticism.”

From the U.S. healthcare business front —

  • MedCity News points out that “When asked what the key issues influencing benefits strategy are, 80% of employers said competition for talent, 67% said rising costs, 41% said a focus on inclusion and diversity and 39% said increasing mental health problems, according to a recent Willis Towers Watson survey.”
  • Fierce Healthcare relates
    • “While payers are facing headwinds going into the latter part of this year, the ongoing financial impacts of healthcare’s labor shortage will be felt in the hospital sector far longer, according to a new report from analysts at Moody’s Investors Service.
    • “The “acute” impacts of labor issues have tapered off, according to the report, but “the budgetary aftershocks will reverberate for years to come.” The analysts expect that the labor issues will pull down hospitals’ operating results through 2024, if not longer.
    • “For example, though conditions have improved, the industry’s nursing shortage is expected to extend through 2030, according to projections from the Bureau of Labor Statistics. This will force hospitals and other providers to develop and roll out new strategies that blunt the impacts, the Moody’s analysts said.
    • “Hospitals are benefiting from some expense relief as staffing has become easier and the need to use pricey contract labor has decreased,” the analysts wrote in the report. “But it will take time for improved margins to follow, and labor issues will remain an underlying sector challenge.”

Weekend update

David Ermer–Congress, Employee Wellness Programs, Generative AI, Mental health care, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC —

From the mental health coverage front —

  • Fierce Healthcare tells us,
    • “The United Health Foundation, the company’s philanthropic arm, each year releases America’s Health Rankings, which dive into major healthcare trends across the country. The latest analysis of that data examines how different populations are experiencing the rising tide of mental health concerns.
    • “For example, adults with disabilities were 3.5 times more likely to report frequent mental distress and 3.5 times more likely to have had a major depressive episode in the last year.
    • “This data is highlighting the need to take a closer look,” said Yusra Benhalim, M.D., senior national medical director at Optum Behavioral Health Solutions, in an interview. “I think we need to kind of lean in a little bit more and understand what the experience is like for individuals with disabilities.”
  • Health Affairs Forefront considers whether the private sector lead in addressing this mental health equity crisis. The FEHBlog thinks it can.

From the generative AI front —

  • The Wall Street Journal reports,
    • “Hundreds of doctors across the U.S. have entrusted recordings of their private talks with patients to a startup promising to turn the conversations into usable medical records through artificial intelligence.
    • “The technology makes multiple errors while producing the reports, such as failing to use correct medical terminology and adding medicines a patient isn’t taking, according to current and former workers.
    • “To fix those errors, health-tech startup DeepScribe relies on 200 human contractors to listen to the medical conversations and revise the records, the company’s founders said. The workers also use Google searches to find billing codes.”
  • This reminds the FEHBlog of a situation that occurred nearly thirty years ago. A client decided to use then new scanning technology to feed paper claims into its claims system for auto-processing. The client wound up needing at least a hundred people to correct errors in the scans. Over time the technology improved, and human assistance dropped off to reasonable levels. The FEHBlog is certain that, in due time, generative AI will be able to create these reports without human assistance.

From the U.S. healthcare business front, NPR warns providers have begun to bill patients and their health plans for responding to messages posted on the provider’s patient portal. Before long, generative AI will be able to reply on the doctor’s behalf.

From the wellness front, Fortune Well shares expert advice on four habits that aging folks need to adopt, besides exercise, to stay fit.

Check out last Monday’s Econtalk episode in which Russ Roberts interviews Lydia Dugdale about her book, the Lost Art of Dying.

Friday Factoids

David Ermer–Generative AI, HIPAA Privacy and Security Rules, HSA, OPM, Patient safety, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us, “The Office of Personnel Management on Friday proposed new regulations aimed at granting federal agencies greater flexibility in selecting new federal employees during the hiring process.” The public comment deadline is September 19, 2023.
  • Federal News Network offers a table of federal government return-to-office policies.
  • The Society for Human Resource Management informs us,
    • “The U.S. Citizenship and Immigration Services (USCIS) announced Friday a new Form I-9—which has been streamlined and shortened—that employers should use beginning Aug. 1, 2023.
    • “Employers may continue to use the older Form I-9 (Rev. 10/21/19)  through Oct. 31., 2023. After that date, they will be subject to penalties if they use the older form. The new version will not be available for downloading until Aug. 1.  
    • “Additionally, the U.S. Department of Homeland Security (DHS) issued a final rule that allows the agency to create a framework under which employers could implement alternative document examination procedures, such as remote document examination. The new form subsequently has a checkbox to indicate when an employee’s Form I-9 documentation was examined using a DHS-authorized alternative procedure.
    • “At this time, the final rule only allows employers using E-Verify to use alternative verification methods.”
  • Healthcare Dive notes
    • “The Federal Trade Commission and the HHS’ Office for Civil Rights are warning hospitals and telehealth companies about embedding online tracking technologies on their websites or apps, saying the trackers risk exposing consumers’ personal health data to third parties. 
    • “The trackers, like the Meta Pixel or Google Analytics, collect identifiable information about users and could reveal information about health conditions, diagnoses, treatments, frequency of visits and more, the agencies wrote in a letter to about 130 health systems and telehealth providers.
    • “The warning marks the latest move from regulators regarding the healthcare industry’s use of tracking technologies, which monitor user behavior on websites. Sharing consumers’ health data with third parties, like advertisers, has been a recent target of FTC oversight.”

Following up on the tornado that struck a Pfizer factory in Rocky Mount, NC, STAT News reports

  • “Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does not appear to have caused “any major damage” to areas that produce medicines.
  • “The company reported most damage from the storm occurred at a warehouse that stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance personnel. As a result, it remains unclear about the extent to which destruction at the facility — which produces nearly 8% of all sterile injectables used in U.S. hospitals — will exacerbate a growing shortage of prescription drugs across the country.”

The Food and Drug Administration also issued a report on the incident.

From the medical malpractice front, STAT News points out

  • “A new study published this week in BMJ, * * * estimates that “371,000 people die every year following a misdiagnosis, and 424,000 are permanently disabled — a total of 800,000 people suffering “serious harm,” said David Newman-Toker, the lead author of the paper and a professor of neurology at Johns Hopkins School of Medicine and director of its Center for Diagnostic Excellence. Settling on an exact number is hard because many cases of misdiagnosis go undetected, he said. It could be fewer than his study identified or more — between half a million and a million — though in any event, it would be the most common cause of death or disability due to medical malpractice. 
  • “He likens the issue of misdiagnosis to an iceberg, saying cases leading to death and disability are but a small fraction of the problem. “We focused here on the serious harms, but the number of diagnostic errors that happen out there in the U.S. each year is probably somewhere on the order of magnitude of 50 to 100 million,” he said. “If you actually look, you see it’s happening all the time.” 
  • “But misdiagnoses typically don’t lead to severe consequences because, most times, people aren’t visiting the doctor with a serious condition. “The risk level just walking through the door in the doctor’s office that something horrible is going to happen to you because of a diagnostic error is actually quite low,” said Newman-Toker.”

In related news “[The American Hospital Association] AHA today released its quarterly Health Care Plan Accountability Update, featuring the latest news on AHA efforts to hold commercial health insurers accountable for policies that can delay care for patients, burden health care providers and add unnecessary costs to the health care system. READ MORE.”

From the factoid front —

  • HealthEquity suggests three ways to drive health savings account plan adoption.
  • Beckers Payer Issues points out how seven payers are using artificial intelligence.
  • MedTech Dive reports, “Intuitive Surgical posted strong robotic volume growth in the second quarter and raised its full-year procedure outlook but said patient interest in new weight-loss drugs is curbing demand for bariatric surgeries.”

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Electronic health records, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • Govexec informs us
    • “The Senate continues to advance spending bills without controversy and with bipartisan support, offering hope that lawmakers will avoid a lapse in appropriations this fall. 
    • “The [Senate Appropriations Committee] has now approved eight of the 12 annual must-pass spending measures, most of which have won unanimous approval. Sen. Patty Murray, D-Wash., who chairs the appropriations committee, announced Thursday her panel would hold votes on the final four funding packages next week. Murray said ahead of Thursday’s votes that she was focusing on passing bills “that can actually be signed into law.”  * * *
    • “The House Appropriations Committee has approved 10 of the 12 spending bills, all largely along party-line votes. House Speaker Kevin McCarthy, R-Calif., said on Wednesday he planned to bring those to the House floor soon, adding his intention was to have the process complete before current funding expires on Sept. 30. Without commenting on the vast differences between the two sets of bills, McCarthy called it “a positive” that the Senate was already moving its spending measures.”
  • The Affordable Care Act regulators issued a letter encouraging employers and other plan sponsors to extend the special employer-sponsored health plan enrollment period for employees who lost Medicaid or CHIP coverage for themselves or family members beyond the sixty days required by law.  
  • The Department of Health and Human Services released guidance “to clarify the prohibition at 45 CFR § 162.412(b) that a health plan may not require a healthcare provider that has been assigned an NPI to obtain an additional NPI.” However, “it does not prohibit a health plan from requiring that a subpart that does not have a unique NPI obtain a unique NPI as a condition of enrollment with the health plan.”
  • The American Academy of Actuaries posted its annual report outlining the factors likely to drive premium changes in the individual and small group insurance markets for the next plan year, in this case, 2024. 

From the public health front —

  • MedPage Today informs us,
    • “A second booster with an mRNA bivalent vaccine offered the best protection against severe COVID-19 due to the Omicron BA.5 variant in older adults, and protection appeared to wane less than with the monovalent shot, a large retrospective study out of Italy showed.”
  • The National Institutes of Health announced
    • “Omega-3 fatty acids, which are abundant in fish and fish oil supplements, appear promising for maintaining lung health, according to new evidence from a large, multi-faceted study in healthy adults supported by the National Institutes of Health. The study provides the strongest evidence to date of this association and underscores the importance of including omega-3 fatty acids in the diet, especially given that many Americans do not meet current guidelines. Funded largely by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, the study results were published in the American Journal of Respiratory and Critical Care Medicine.” 
  • Cigna Healthcare offers five tips for healthier sleep.

From the EHR interoperability front, check out this fascinating Computer World update

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • More than three years after the onset of the COVID-19 pandemic, only 1% of primary care clinicians surveyed by the Larry A. Green Center and the Primary Care Collaborative believe their practice has fully recovered from its impacts, and 61% characterize U.S. primary care as “crumbling.”
    • “Nearly 80% of respondents felt the current workforce is undersized to meet patient needs, and just 19% of clinicians report their practices are fully staffed.
    • “The results are emblematic of a “larger national crisis,” and policymakers must act to reinforce primary care, said Rebecca Etz, co-director of the Larry A. Green Center, in a statement. “ … It is not a matter of if, but when there will be another pandemic … If we don’t act soon, primary care won’t be there when it happens.
  • Beckers Hospital Review tells us,
    • “Severe winds from an EF-3 tornado on July 19 crushed a North Carolina Pfizer manufacturing plant that made nearly 25 percent of the drugmaker’s sterile injectables used by U.S. hospitals. 
    • “The facility manufactured and stored injectable drugs, and 50,000 pallets of therapies were destroyed by wind and rain, according to local news outlets, NBC affiliate WRAL and CBS affiliate WNCN. 
    • “At 1.4 million square feet, the facility was one of the largest sterile injectable plants in the world, according to Pfizer’s website. The site made nearly 400 million products every year, including solutions of anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers.
    • “The tornado touched down in Rocky Mount, N.C., at 12:36 p.m., according to a tweet from the county’s government.
    • “Pfizer said there are no reports of workers with serious injuries.” 
  • The Wall Street Journal reports,
    • “A surge in heart procedures and higher demand for cold and flu medicines helped Johnson & Johnson report solid gains in revenue and profit for the second quarter.
    • “J&J’s quarterly earnings are regarded as a bellwether for healthcare because the company has large pharmaceutical, medical-device and consumer-health divisions. The overall improvement in J&J’s results suggests an easing of some of the challenges that have dogged health-product makers in recent years: supply-chain constraints, hospital staffing shortages and Covid-19 pandemic restrictions. “You now have hospital staffing much more on a routine cadence,” J&J Chief Financial Officer Joseph Wolk said in an interview Thursday.” 
  • Healthcare Dive adds,
    • “Abbott on Thursday posted a decline in second-quarter net earnings as demand for its COVID-19 testing supplies continued to wane, but the company raised the outlook for its base business on higher sales of its medical devices and nutrition products.
    • “Excluding COVID-19 tests, organic sales exceeded the company’s expectations with a nearly 12% increase in the quarter.”
  • The Society for Human Resource Management explores the limited impact that the Supreme Court’s affirmative action in education decision may have on employer affirmative action and diversity, equity, inclusion, and accessibility programs.

Midweek Update

David Ermer–Congress, COVID-19, FDA, OPM, U.S. Healthcare–

From Washington, DC,

  • Fedweek compares the House and Senate versions of the appropriations bill that funds OPM and the FEHBP.
  • The Federal Times reports,
    • “Reproductive health advocacy groups and Democratic lawmakers are pressing the Office of Personnel Management on why some insurers offer fewer infertility treatments than they’re required to in federal employee health plans.
    • “In a letter to OPM Director Kiran Ahuja obtained by Federal Times, Rep. Gerry Connolly (D-Va.) and Sen. Tammy Duckworth (D-Ill.) said certain providers under the Federal Employee Benefits Program — which serves 8 million beneficiaries — are denying coverage of standard fertility preservation treatments. * * *
    • “For the 2023 plan year, OPM announced it was requiring all FEHB carriers to “provide coverage for standard fertility preservation procedures for … iatrogenic infertility.” Per KFF, “Iatrogenic, or medically induced, infertility refers to when a person becomes infertile due to a medical procedure done to treat another problem, most often chemotherapy or radiation for cancer.”
  • The Federal Times article contends that FEHB plans are not fully compliant with this mandate. OPM has created a process for members to ask for OPM review of claim decisions (following internal plan reconsideration). This process can work out any compliance kinks.
  • InsiderNJ adds,
    • “Today, U.S. Senator Cory Booker (D-NJ) and U.S. Representative Rosa DeLauro (D-CT) reintroduced the bicameral Access to Infertility Treatment and Care Act, legislation that would require more health insurers to provide coverage for infertility treatment, as well as fertility preservation services for individuals who undergo medically necessary procedures that may cause infertility, such as chemotherapy. * * *
    • “The full text of the bill can be found here.”
  • AHA News informs us,
    • “The Federal Trade Commission and Department of Justice July 19 released for comment through Sept. 18 updated guidance describing how the agencies review mergers and acquisitions to determine compliance with federal antitrust laws. The agencies said the document outlines 13 principles they may use when determining whether a merger is unlawfully anticompetitive and clarifies the frameworks and tools they may use when analyzing a merger with respect to each guideline. 
    • “FTC and DOJ initiated the update with a request for public input in January 2022, and plan to use the comments to update the draft before finalizing the guidelines. For more on the draft guidelines, see the agencies’ fact sheet. AHA intends to submit comments on the proposed guidelines.”
  • Washington Technology tells us,
    • “Maximus is locked in a protest fight after the U.S. Postal Service chose Deloitte Consulting for a $175 million contract to the consulting firm to build a new health benefits system.
    • “By 2025, USPS plans to move that new system for delivering health insurance benefits to its employees. USPS tasked Deloitte Consulting to build the system that would include enrollment processing, eligibility determinations, data analytics and other features, according to solicitation documents on GovTribe.
    • “Maximus filed a protest with the Government Accountability Office on Tuesday to challenge the award. The Office of Personnel Management is managing the contract on behalf of the Postal Service. * * *
    • “A decision from GAO is due Oct. 26.”
  • Cardiovascular Business points out that “The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling nearly 350,000 implantable cardiac devices due to continued issues with their ability to deliver high voltage therapy when necessary.”

From the public health front –

  • The Wall Street Journal reports,
    • “You might know a Covid-19 super-dodger who was infected with the virus but didn’t get sick. Their luck could be written in their genes. 
    • “A DNA variation that affects the immune system can boost a person’s odds of avoiding Covid-19 symptoms, a study found. The work, published Wednesday in the journal Nature, helps explain why some people infected with the virus that causes Covid-19 don’t fall ill. 
    • “The T cells of some people with the variation can find and kill the virus without having seen it before, researchers said. That is because the part of the virus their T cells home in on is similar enough to common coronaviruses they have already encountered.  
    • “There are people out there that have got strong prior immunity from their common coronavirus exposures,” said Danny Altmann, a professor of immunology at Imperial College London, who wasn’t involved in the study. The work could help researchers design better vaccines, Altmann said.” 
  • STAT News relates,
    • “Cancer drugs can burn through tumors like wildfire, killing off the vast majority of malignant cells. But a few stubborn cells often end up surviving, seeding a recurrence of the disease. The prevailing theory behind this drug resistance is built on natural selection: Among the vast and genetically diverse population of cancer cells in a tumor, some have random mutations that help these cells survive an onslaught.
    • “But this is not the full picture,” said Yogesh Goyal, a cancer researcher at Northwestern University. Goyal and his colleagues at the University of Pennsylvania demonstrated in a series of experiments that cancer cells can survive treatments just by having certain genes turned on, even if they were nearly genetically identical to cancer cells that died but had activated different genes.
    • “We think this work stands to really change how we think about therapy resistance,” said Arjun Raj, the study’s co-senior author and a bioengineer at the University of Pennsylvania.
    • “In other words, mutations alone cannot fully explain resistance to cancer therapy. Instead, researchers may need to look more closely at the assemblage of genes turned on or off at any given time in a cancer cell — what scientists call the cell’s transcriptional profile — to better understand whether it will respond to a certain drug, Goyal said.”

From the U.S. healthcare business front —

  • Healthcare Dive lets us know
    • “Elevance’s second-quarter earnings alleviated recent cost trend and utilization concerns, as the health insurer reported lower medical spending than analysts expected.
    • “The payer beat Wall Street expectations for the quarter with revenue of $43.7 billion, up 13% year over year, and profit of $1.9 billion, up 14% year over year. * * *
    • “Elevance reported a medical loss ratio of 86.4%, down 70 basis points year over year due to premium rate adjustments reflecting the post-pandemic cost of care, CFO John Gallina told investors on a Wednesday morning call.”
  • Fierce Healthcare informs us,
    • “Amar Desai, M.D., wrote in a post on LinkedIn Wednesday that he is “thrilled” to come back to the UnitedHealth Group subsidiary as the CEO of Optum Health. Desai previously spent several years in leadership roles at Optum before taking the role of president of healthcare delivery at rival CVS Health.
    • “Desai is also an associate clinical professor of medicine at the Keck School of Medicine at the University of Southern California. He previously served as president of HealthCare Partners, which was acquired in 2019 by UHG as part of DaVita Medical Group.”
  • The Society for Human Resource Management reports
    • “U.S. organizations are budgeting an average increase of 4 percent in 2024, according to consulting firm WTW, which surveyed more than 2,000 U.S. organizations for its Salary Budget Planning Survey. That number is down from the actual increase of 4.4 percent in 2023, and the 4.2 percent increase in 2022, but the projected 2024 figures remain higher than the 3.1 percent salary increase budget in 2021 as well as other increases in pre-pandemic years.”

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.