Thursday Miscellany

Thursday Miscellany

From Washington, DC —

  • Medscape tells us
    • “The US Food and Drug Administration (FDA) [on July 31] cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.
    • “The device helps identify lesions in real time, and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.”
  • MedPage Today lets us know,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously — 10 to 0 — in favor of nirsevimab (Beyfortus) for protecting a wide swath of at-risk infants from respiratory syncytial virus (RSV).
    • “At a meeting on Thursday, ACIP recommended that all infants younger than 8 months who are born during or approaching their first RSV season receive one dose of nirsevimab.
    • “The advisory committee also voted 10-0 to recommend that children 8 to 19 months who are at increased risk of severe RSV and approaching their second RSV season receive one dose of the monoclonal antibody against RSV.
    • As a result of this action, FEHB plans and health plans generally must cover the preventive service with no cost sharing when delivered in-network.
  • The Labor Departments Office of Federal Contract Compliance Programs announced
    • “a final rule titled “Pre-enforcement Notice and Conciliation Procedures.”
    • “The final rule modifies the agency’s earlier rule, “Nondiscrimination Obligations of Federal Contractors and Subcontractors: Procedures to Resolve Potential Employment Discrimination” which took effect on December 10, 2020. * * *
    • “To learn more, read Acting Director Michele Hodge’s blog about the final rule here. You can also read the Final Rule here.  
    • “The final rule will take effect on September 5, 2023.”

From the public health front —

  • UPI reports, “In examining real-world data on the long-term health of elderly patients who received the COVID-19 vaccine, researchers at Brown University and Boston-based Hebrew SeniorLife determined that the Moderna variety was the safest and most effective for older adults.”
  • The Washington University School of Medicine announced,
    • “Scientists at Washington University in St. Louis have developed a breath test that quickly identifies those who are infected with the virus that causes COVID-19. The device requires only one or two breaths and provides results in less than a minute.
    • “The study is available online in the journal ACS Sensors. The same group of researchers recently published a paper in the journal Nature Communications about an air monitor they had built to detect airborne SARS-CoV-2 — the virus that causes COVID-19 — within about five minutes in hospitals, schools and other public places.”
  • MedPage Today informs us
    • “Thymectomy carried a substantially increased risk of all-cause mortality and cancer for adults, a “landmark” study showed.
    • “Adults who had undergone thymectomy had at least double the risk of all-cause mortality and cancer at 5 years post-surgery compared with matched patients who had undergone cardiothoracic surgery without thymectomy * * *.
    • “Incidental thymectomy is common during cardiothoracic surgery due to the pyramid-shaped organ’s location in the chest in front of the heart where surgeons need to access the surgical field.
    • “While the thymus plays a critical role in normal immune system development, it was thought to be safe to remove in adulthood, “particularly since the thymus naturally involutes with age,” the researchers noted.
    • “Their conclusion from the study was that the thymus continues to be functionally important for human health in adulthood.”
  • HHS’s Agency for Healthcare Research and Quality has made available a
    • Toolkit for Improving Perinatal Safety, a second bundle of AHRQ tools is available to improve the safety culture of labor and delivery (L&D) units. The second bundle provides resources that align the toolkit’s adaptive care processes with the clinical care processes recommended in the Alliance for Innovation on Maternal Health (AIM) program.
    • “The new tools are designed to help L&D units reduce obstetric hemorrhage and severe hypertension in pregnancy, two leading known causes of preventable maternal mortality and severe maternal morbidity in the United States.”
  • On a related note, Fierce Healthcare reports
    • “To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.”To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.
    • “HCSC said it wants to increase access to providers and reduce gaps in healthcare as well as engage and educate residents about maternal and infant well-being. The customer-owned health insurer plans to install the program in the states in which it operates: Illinois, Montana, New Mexico, Oklahoma and Texas.
    • “The initiative will first launch in the Lone Star State, HCSC said.
    • “We’re collaborating with trusted community organizations and partners, leveraging their knowledge, experience and talents on a local level,” HCSC Chief Clinical Officer Monica Berner, M.D., said in a press release. “We seek to build healthier communities by using our resources to respond to societal needs.”
  • KFF News points out that “Doctors Sound Alarm About Child Nicotine Poisoning as Vapes Flood the US Market.”

From the U.S. healthcare business front —

  • Beckers Payers Issues notes
    • “The Cigna Group raised its year-end revenue projections to $190 billion and reported a 6 percent decrease in shareholders’ net income, according to the company’s second quarter earnings published Aug. 3.
    • “Total revenues in the second quarter were $48.6 billion, up 7 percent year over year.
    • “In the second quarter, net income was nearly $1.5 billion, down 6 percent from $1.6 billion year over year. The company cited an absence of income from recently divested businesses, including the sale of businesses to Chubb in six countries and divestiture from a joint venture in Turkey.
    • “Evernorth pharmacy revenues rose 7 percent year over year to $35.2 billion. The insurance side of the business, Cigna Healthcare, reported second-quarter revenues of $12.7 billion, up 11 percent from the previous year.
    • “The company’s medical loss ratio was 81.2 percent in the second quarter, compared to 80.7 percent during the same period last year.”
  • Healthcare Dive adds
    • “Investors were concerned about medical cost trends coming into the second quarter, but health insurers have largely bucked the worst of rising expenses. Cigna, one of the last major payers to report earnings, was no different.
    • “We planned and priced for more normalized levels of utilization this year. Our year-to-date claims experience has been broadly in line with this expectation,” Cigna CFO Brian Evanko said in a Thursday morning call with investors.”
    • Cigna’s medical loss ratio, or how much of the premium dollar is spent on patient care, was 81.2% in the second quarter, according to new financial results — better than analysts expected.
  • Healthcare Dive also reports
    • “Telehealth company Amwell lowered its 2023 revenue outlook after missing analyst expectations and racking up another non-cash goodwill impairment charge in the second quarter.
    • “The company now expects to bring in revenue between $257 million and $263 million for the year, compared with earlier guidance of $275 million to $285 million, Amwell said in second-quarter results released Wednesday. 
    • “Amwell’s revenue declined 3% year over year to $62.4 million in the quarter. The telehealth vendor posted a net loss of $93.5 million, which included a $27.3 million goodwill impairment charge to make up for the “sustained decrease” in Amwell’s stock and market capitalization, according to an SEC filing.”
  • Fierce Healthcare lets us know
    • “UnitedHealthcare tapped 66 not-for-profit organizations spread over 12 states to receive grant funding to help expand access to care.
    • “The $11.1 million in grant funding, which falls under UnitedHealthcare’s Empowering Health program, aims to help improve the healthcare options of individuals living in underserved communities by addressing the social determinants of health, the insurance giant said. Specifically, it’ll target food insecurity, social isolation, behavioral health issues and health literacy efforts.
    • “Some of the organizations to receive funds include the Upstate Foundation in Syracuse, New York, CHRIS 180 in Atlanta and Trellis in Minneapolis and Saint Paul.”

Tuesday Tidbits

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’s Tidbits

Photo by Patrick Fore on Unsplash

From the public health front —

  • Health Affairs launched a new publication called Health Affairs Scholar. Health Affairs also made available its lead article in the new publication titled “Ten Health Policy Challenges for the Next Ten Years.”
  • MedPage Today reports
    • “An increase in pediatric type 2 diabetes cases that began during school closures amid the COVID-19 pandemic has not returned to baseline, according to a retrospective study.
    • “Compared with the year before COVID emerged, the number of new pediatric type 2 diabetes cases ballooned during the first year of the pandemic (March 2020 through February 2021; P=0.005), and then jumped again during the second year (March 2021 through February 2022; P=0.0006), reported Esther Bell-Sambataro, MD, of Nationwide Children’s Hospital and the Ohio State University in Columbus, during ENDO 2023opens in a new tab or window, the annual meeting of the Endocrine Society.”
  • The Food and Drug Administration adds
    • “Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by mouth to treat pediatric type 2 diabetes. Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.
    • “Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, M.D., M.P.H., associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”
  • Also from the FDA
    • “Today, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. 
    • “We believe this guidance and the launch of the pilot program are important steps towards addressing safety risks posed by the use of poorly performing laboratory-developed tests,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments.”
  • The National Institutes of Health informs us
    • “A recent follow-up analysis of data from an international, National Institutes of Health-funded clinical trial suggests daily low-dose aspirin increases the risk of anemia in people age 65 years and older by approximately 20%. Given these findings, older adults on low-dose aspirin and their care providers may want to consider periodic monitoring of red blood cells or hemoglobin. Anemia in older adults is associated with functional decline, increased fatigue, disabilities, depressive symptoms, and cognition problems.
    • “Published in the Annals of Internal Medicine, scientists from the Aspirin in Reducing Events in the Elderly (ASPREE) study examined the effect of long-term low-dose aspirin use on incident anemia and the effect of aspirin on changes in hemoglobin concentration, as well as ferritin levels, as an indicator of iron deficiency. The researchers found that low-dose aspirin led to increased incident anemia in otherwise healthy older adults at enrollment, independent of major bleeding.”
  • The U.S. Preventive Services Task Force released a new recommendation — “Adults 64 years or younger, including pregnant and postpartum persons: Screen for anxiety. Grade: B” — and reissued a 2014 recommendation — “Adults, including pregnant and postpartum persons, and older adults (65 years or older): Screen for major depressive disorder (MDD). Grade: B.”
  • ICD10 Monitor alerts us
    • “The Centers for Disease Control and Prevention (CDC) released the ICD-10-CM codes for the 2024 fiscal year (FY) on Friday, June 16. This release included 395 additions, 25 deletions, and 13 revisions. The deletions are due to the expansion of the diagnosis codes. The total ICD-10-CM codes for FY 2024 is 74,044. These codes will be effective starting with Oct. 1, 2023, visits or discharges.”

From the federal employment front —

  • FedWeek tells us
    • “A hearing set for this week on three high-profile work backlogs likely will add to the pressure from House Republicans for agencies to reduce their levels of telework.
    • “The hearing in the House federal workforce subcommittee will “examine the backlogs of military and civil service personnel records requests, the Social Security Administration’s customer service line and disability claims, and passport backlogs. This hearing will also examine what steps agencies are taking to clear backlogs and provide timely service and support to the American people,” according to the panel.”
  • Govexec reports
    • “An advisory council dedicated to examining issues related to federal employee compensation issued no new recommendations for changes to the map of locality pay areas in a newly released report, instead urging quick implementation of proposals that already received a green light from the president’s pay agent.
    • “In a report dated Feb. 4 but only published by the Office of Personnel Management this month, the Federal Salary Council said none of the regions currently being studied by the Bureau of Labor Statistics regarding the pay disparity between federal workers and private sector employees currently meet the criteria to become locality pay areas.
    • “Instead, the council, which is made up of a mix of presidentially appointed federal human resources experts and representatives of unions and other federal employee organizations, focused its report on reiterating a series of recommendations approved last December by the president’s pay agent, a body made up of OPM Director Kiran Ahuja, Office of Management and Budget Director Shalanda Young and then-Labor Secretary Marty Walsh. But in order for those recommendations to be implemented, OPM must first issue regulations.
    • “In terms of discreet additions to the map of locality pay areas, the salary council urged swift action to implement the new locality pay areas of Fresno, Calif.; Reno, Nev.; and Spokane, Wash. Additionally, Dukes and Nantucket counties, Mass., would join the Boston locality pay area; Huron County, Mich., will join the Detroit locality pay area; and Pacific and San Juan counties, Wash., would be included in the Seattle locality pay area. And Greensville County and the city of Emporia in Virginia would both become part of the Richmond locality pay area.”
  • and
    • “The U.S. Postal Service is preparing layoff notices that could take effect in September, notifying staff earlier this month of the potential for workforce reductions. 
    • “USPS is allowing impacted workers to apply for lateral or downgraded positions, anticipating it can absorb the employees elsewhere. The changes will affect non-union staff in the logistics division serving in management positions. James Lloyd, a USPS director for labor relations policies and programs, said the reductions were developed “based on an evaluation of staffing criteria and manager levels” by headquarters personnel.”

From the U.S. healthcare business front —

  • HHS’s Agency for Healthcare Quality and Research released its annual update to the Compendium of U.S. Health Systems.
    • “The Compendium of U.S. Health Systems includes information on U.S. health systems, defined in this analysis to include at least one hospital and at least one group of physicians providing comprehensive care, and who are connected with each other and with the hospital through common ownership or joint management. The Compendium is updated on a regular basis, with the newest files released in June 2023:
    • 2021 Compendium (New)
    • 2020 Compendium (New)
    • 2018 Compendium
  • Beckers Hospital Review ranks 35 health systems by revenue.
  • BioPharma Dive reports
    • “Eli Lilly has agreed to buy Dice Therapeutics for about $2.4 billion in a deal that gives the pharmaceutical giant a promising oral autoimmune disease drug in clinical testing.”
    • “Lilly will buy Dice, a young biotechnology company that went public in 2021, for $48 per share in cash, the companies announced Tuesday. The purchase price equates to a roughly 42% premium to Dice shares’ closing price Friday and about 40% above the average trading price over the last month.
    • “The deal is expected to close in the third quarter, pending regulatory clearance and the tender of a majority of Dice’s outstanding stock.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC, the House Rules Committee held a four-hour hearing on the debt ceiling compromise bill (HR 3746) this afternoon. The Wall Street Journal adds

“House Republican leaders projected confidence Tuesday that the debt-ceiling deal struck with President Biden would draw enough support to pass, while some conservative lawmakers angrily denounced the agreement.

“The bill advanced (7-6 vote) past a closely watched procedural hurdle in the Rules Committee late Tuesday, and a final House vote is expected as soon as Wednesday night. While the bill appears on track to gain sufficient Republican and Democratic votes to pass the House and then the Senate by the June 5 deadline, it could still run into procedural obstacles, complicating the race to avoid an unprecedented default.”

From the public health front —

  • The University of Minnesota informs us
    • “[As of last Friday] the two main metrics that the Centers for Disease Control and Prevention (CDC) uses to track US COVID-19 activity—hospitalizations and deaths—continue to decline, according to the latest data. Hospitalizations for COVID are down 11% compared to a week ago, and deaths from the virus are down 13.3%.
    • “The hospitalization map, which reflects activity by county, replaces the CDC’s earlier community levels, and there are currently only a few hot spots, some in Texas and in small portions of Nebraska and Louisiana.
    • “Early indicators—regional test positivity and emergency department (ED) visits—also show no signs of increase. Test positivity at the national level is 4.3%, down 0.7% from a week ago. The only region showing a slight increase is the part of the Southwest that includes California, Nevada, and Arizona. Only 0.5% of ED visits last week were due to COVID, down 10.8% from the previous week. There are no major rises in COVID positivity in wastewater surveillance.”
  • HHS’s Agency for Healthcare Quality and Research issued a report on “Treated Prevalence of Commonly Reported Health Conditions, 2016 to 2020.”
  • PBS informs us,
    • “The United States grew older, faster, last decade.
    • “The share of residents 65 or older grew by more than a third from 2010 to 2020 and at the fastest rate of any decade in 130 years, while the share of children declined, according to new figures from the most recent census.
    • “The declining percentage of children under age 5 was particularly noteworthy in the figures from the 2020 headcount released Thursday. Combined, the trends mean the median age in the U.S. jumped from 37.2 to 38.8 over the decade.
    • “America’s two largest age groups propelled the changes: more baby boomers turning 65 or older and millennials who became adults or pushed further into their 20s and early 30s. Also, fewer children were born between 2010 and 2020, according to numbers from the once-a-decade head count of every U.S. resident. The decline stems from women delaying having babies until later in life, in many cases to focus on education and careers, according to experts, who noted that birth rates never recovered following the Great Recession of 2007-2009.”

From the Rx coverage front —

  • Fierce Healthcare updates us on the soaring employee demand for anti-obesity drugs.
  • Also, Fierce Healthcare relates,
    • “Optum Rx is rolling out new programs aimed at supporting independent and rural pharmacies in closing care gaps beginning in June.
    • “The pharmacy benefit manager said Tuesday that the new initiatives will focus on three key areas: helping patients in underserved areas connect to community resources, improving maternal and fetal health by boosting access to key supplies and deploying community pharmacies to address healthcare deserts.
    • :The new initiatives kick off what Optum said is a “broader, industry-leading commitment to bridge resource gaps in the community.”
    • “These initiatives provide opportunities not only to help patients but also to offer appropriate compensation that recognizes the clinical expertise and unique capabilities our community and independent pharmacy partners have to meet the needs of their patients,” said Heather Cianfrocco, CEO of Optum Rx, in the release.”

From the medical and prescription drug research front

  • The NIH Director’s blog tells us,
    • “Biomedical breakthroughs most often involve slow and steady research in studies involving large numbers of people. But sometimes careful study of even just one truly remarkable person can lead the way to fascinating discoveries with far-reaching implications.
    • “An NIH-funded case study published recently in the journal Nature Medicine falls into this far-reaching category [1]. The report highlights the world’s second person known to have an extreme resilience to a rare genetic form of early-onset Alzheimer’s disease. These latest findings in a single man follow a 2019 report of a woman with similar resilience to developing symptoms of Alzheimer’s despite having the same strong genetic predisposition for the disease [2].
    • “The new findings raise important new ideas about the series of steps that may lead to Alzheimer’s and its dementia. They’re also pointing the way to key parts of the brain for cognitive resilience—and potentially new treatment targets—that may one day help to delay or even stop the progression of Alzheimer’s.”
  • BioPharma Dive reports
    • “An experimental hemophilia drug developed by Pfizer significantly reduced bleeding frequency compared to on-demand or preventive clotting factor proteins, the drugmaker said Tuesday. Called marstacimab, the drug was not associated with the kind of dangerous blood clotting that has delayed or sidelined similarly acting drugs from Novo Nordisk and Bayer.
    • “If approved, marstacimab would compete with established medicines like Roche’s Hemlibra as well as newer treatments like CSL Behring’s gene therapy Hemgenix and Sanofi’s long-acting drug Altuviiio. These therapies offer options for patients beyond regular infusions of engineered clotting factor proteins.
    • “Marstacimab requires a weekly subcutaneous shot, while Hemlibra can be administered subcutaneously as infrequently as once every four weeks after an initial dosing phase. Gene therapies like Hemgenix, or another from BioMarin Pharmaceutical that’s now under review, are intended to be a one-and-done treatment, although their long-term durability has not been proven.”

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Nonprofit hospital operator Ascension Healthcare reported a loss from operations of $1.8 billion on revenue of $21.3 billion for the nine months ending March 31, as it struggled with higher operating costs and sustained revenue challenges driven by continued impacts of the COVID-19 pandemic and inflationary pressures.
    • “An improvement in total surgical volumes, especially outpatient surgeries and emergency room visits, didn’t outpace growing expenses for Ascension, which increased by $804 million year over year in the nine-month period.”
  • Per Fierce Healthcare
    • “Advocate Health, the newly formed marriage of major nonprofits Advocate Aurora Health and Atrium Health, reported a $10.4 million operating income (0.1% operating margin) and $578.7 million net gain in its first-ever Q1 earnings report, released Tuesday.
    • “The 67-hospital entity tallied more than $7.54 billion in total revenue during the three months ended March 1 thanks to year-over-year increases across each of its major divisions—Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist.”

From the litigation front, STAT News reports, “A federal appeals court ruled Tuesday Purdue Pharma can shield its owners — members of the wealthy Sackler family — from thousands of lawsuits over the role the company played in the opioid crisis in exchange for a contribution of up to $6 billion to a proposed bankruptcy settlement. * * * The U.S. Court of Appeals for Second Circuit, though, ruled a U.S. bankruptcy court was correct in approving the immunity and, moreover, that it was “equitable and appropriate under the specific factual circumstances of this case.” The decision reverses a ruling made last December by a federal judge had sided with the U.S. Trustee. The case now goes back to U.S. bankruptcy court to approve the settlement, although the U.S. Trustee could ask the U.S. Supreme Court to review the appeals court ruling.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

Roll Call tells us,

“President Joe Biden and Speaker Kevin McCarthy on Tuesday tapped proxies to negotiate directly over how to increase the debt limit with time running short before the government runs too low on funds.”

and

“Lawmakers are beginning to think about changing their plans and staying in Washington in the coming weeks as a standoff over increasing the debt limit bears down. Members of both parties’ leadership said on Tuesday that plans for the Senate to recess next week and the House to leave town the following week could shift.”

BenefitsLink pointed out that the Internal Revenue Service released a revenue procedure identifying inflation-adjusted high deductible health plan and health savings account amounts for use in 2024 just in time for FEHB high deductible health plan benefit proposals due May 31.

STAT News reports

“In an unexpected move, the Federal Trade Commission on Tuesday filed a lawsuit to block Amgen from acquiring Horizon Therapeutics, claiming the $27.8 billion deal would make it possible for Amgen to develop monopolies through a tactic that manipulates health coverage and drives up consumer costs.

“At issue is a practice known as bundling. Simply put, a drug company combines two or more medicines in a package deal for health plans and pharmacy benefit managers, which determine lists of medicines that are covered by insurance. The practice has previously sparked concerns that a drug company will unfairly offer higher rebates for bundles in order to win favorable placement.”

From the medical and drug research fronts —

  • The National Institute of Health informs us,
    • “A study from the National Institutes of Health shows that new cases of chronic pain occur more often among U.S. adults than new cases of several other common conditions, including diabetes, depression, and high blood pressure. Among people who have chronic pain, almost two-thirds still suffer from it a year later. These findings come from a new analysis of National Health Interview Survey (NHIS) data by investigators from the National Center for Complementary and Integrative Health (NCCIH) at the NIH, Seattle Children’s Research Institute, and University of Washington, Seattle, and are published in JAMA Network Open.”
  • The New York Times reports
    • “The man should have gotten Alzheimer’s disease in his early 40s — he had a gene mutation that guaranteed it, or so it seemed. Scans of his brain even revealed severe atrophying and the hallmarks of the disease: rough, hard, amyloid plaques and spaghetti-like tangles of tau proteins. But the fatal brain disease did not appear until the man was 67.
    • “Now an intense research effort has discovered why. The man was protected because another mutation in a different gene blocked the disease from entering his entorhinal cortex. That tiny area of the brain is a hub for neurons involved in memory, recognition of objects, navigation and time perception. And it is there that scientists believe that Alzheimer’s disease begins.
    • “A paper on the finding was published Monday in the journal Nature Medicine.
    • More than six million people in the United States have Alzheimer’s, a disease that has been notoriously difficult to treat. Yet here was a man with a mutation that causes the most severe and rapidly progressing form of Alzheimer’s. And his disease was delayed for two decades. If a drug could do what the mutation did, resulting in most people getting Alzheimer’s very late in life, the outcome could be transformative.”

From the SDOH front,

  • the National Institutes of Health shared
    • “New research shows that the economic burden of health disparities in the United States remains unacceptably high. The study, funded by the National Institute on Minority Health and Health Disparities (NIMHD), part of the National Institutes of Health,  revealed that in 2018, racial and ethnic health disparities cost the U.S. economy $451 billion, a 41% increase from the previous estimate of $320 billion in 2014. The study also finds that the total burden of education-related health disparities for persons with less than a college degree in 2018 reached $978 billion, about two times greater than the annual growth rate of the U.S. economy in 2018.”

From the AI department,

  • Beckers Payer Issues informs us
    • Payers are putting artificial intelligence to work. 
    • Google recently launched a new AI-powered cloud program for prior authorization and claims processing. Elevance Health is piloting AI-powered concierge care for members. 
    • Becker’s asked 18 payer executives how AI will transform the insurance industry. [The interview squibs are available in the article.]

From the patient front, here is a link to HHS’s Agency for Healthcare Quality and Research March 2023 Chartbook on Patient Safety.

Monday Roundup

Photo by Sven Read on Unsplash

From Washington DC —

  • The Wall Street Journal reports,
    • “Time isn’t on Washington’s side.
    • “With the U.S. facing a potentially economy-shaking default as soon as next month, logistical hurdles, disagreements on the scope of any talks, a tight legislative calendar and a late start are complicating negotiations over raising the debt ceiling.
    • “President Biden said Monday that the next meeting with congressional leaders will come Tuesday, while responding “no” when asked if there were updates regarding the talks with Republicans. House Speaker Kevin McCarthy (R., Calif.) said that the two sides remain “far apart” and that he would like a deal to be done by this weekend.” * * *
    • “A second meeting with the president and congressional leaders that was originally set to take place on Friday was postponed until early this week. The House and Senate are scheduled to be in session simultaneously for just one more week this month, and Mr. Biden is set to travel overseas for a Group of Seven meeting. Moreover, Republican leaders have so far rejected any short-term debt deal to buy more time.”
  • According to the White House’s briefing room,
    • “President Biden announced his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH), the world’s preeminent biomedical research organization. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader who has the vision and leadership needed to deliver on NIH’s mission to seek fundamental knowledge and promote human health.”  

From the litigation front, the American Hospital Association informs us

“The U.S. Court of Appeals for the 5th Circuit today temporarily restored an Affordable Care Act requirement that most health plans cover certain preventive services without cost sharing. The 5th Circuit ordered that this requirement remain in effect for everyone (except the few health plans challenging the requirement) until it issues a final decision in the case, which is expected later this year. A federal judge in Texas recently vacated the requirement nationwide, prompting the Department of Health and Human Services and plaintiff to appeal the decision and seek this temporary stay.”

From the public health front —

  • HealthDay tells us,
    • “Older Americans are dying of falls at more than double the rate of 20 years ago — with women, men and all racial groups showing increases, according to a new study.
    • “In 2020, the study found, just over 36,500 Americans age 65 and up died of a fall-related injury. That was up from roughly 10,100 deaths in 1999.
    • “Adjusted for age, those numbers translated into a more than twofold increase in the rate of fall-related deaths among older Americans: from 29 per 100,000 in 1999, to 69 per 100,000 in 2020.” * * *
    • The National Council on Aging has a tool for older adults to check their risk of falls.

From the Rx coverage front —

  • MPR relates
    • “The Food and Drug Administration’s (FDA) Pulmonary-Allergy Drug Advisory Committee voted 16:6 in favor for adults, and 17:5 in favor for children (<18 years of age and ≥30kg), that available data support a favorable benefit-risk assessment for neffy® in the treatment of severe allergic reaction (Type 1), including anaphylaxis, for adults and children who weigh more than 30kg. * * *
    • “While not bound to the committee’s recommendations, the FDA does take them into consideration when making final decisions on approval. If approved, neffy would be the first needle-free epinephrine product to treat severe allergic reaction. A decision is expected by mid-2023.”
  • The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension.
  • The Wall Street Journal delves into “How to Get Your Health Insurance to Cover Ozempic and Other Drugs Used for Weight Loss; Tips for checking whether your health plan will pay for a prescription and then getting authorization.”
  • Per Hub International,
    • “CMS recently released its updated Medicare Part D guidelines that can be used by group health plan sponsors to determine whether their plans’ prescription drug coverage is creditable for 2024 and to update the information needed for required Part D disclosures to eligible individuals and to CMS.
    • “To help determine whether prescription drug coverage is creditable, CMS has released the following 2024 parameters for the standard Medicare Part D prescription drug benefit:
      • Deductible: $545 (up from $505 in 2023);
      • Initial coverage limit: $5,030 (up from $4,660);
      • Out-of-pocket threshold: $8,000 (up from $7,400);
      • Total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are not eligible for the coverage gap discount program: $11,477.39 (up from $10,516.25 in 2023); and
      • Estimated total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are eligible for the coverage gap discount program: $12,447.11 (up from $11,206.28).”

From the artificial intelligence front —

  • This week’s episode of the Econtalk podcast features an artificial intelligence discussion between host Russ Roberts and his guest Tyler Cowen. Russ Roberts suggests using ChatGPT to formulate questions for your doctor or your parents’ or your kids’ doctors.
  • Bloomberg examines the use of AI by drug manufacturers.
  • Medcity News looks into the use of AI by pharmacists and PBMs.

From the miscellany department —

  • Fierce Healthcare points out, “Million-dollar claims per million covered employees rose 15% in the past year and 45% from 2019 to 2022, according to a report by Sun Life, a life and disability insurance company.”
  • EHR Intelligence reports,
    • “The Health IT End-Users Alliance has released a consensus statement regarding collecting and using social determinants of health (SDOH) data to support health equity.
    • “The Alliance brings together health information professionals, physicians, hospitals, and other front-line healthcare providers to advance end-user perspectives in health IT policy and standards development.
    • “The statement calls for additional efforts to standardize and increase the uniform collection and reporting of SDOH. The group also calls for more training on collecting this data, better use of appropriate tools and processes to manage and share SDOH, and ongoing research to support these efforts.”
  • Employee Benefit News notes, “Thirteen FSA and HSA-eligible expenses that may surprise you.”

Monday Roundup

Photo by Sven Read on Unsplash

From our Nation’s capital, OPM released its Fiscal Year 2024 Congressional Budget Justification document, which is part of the federal budget process. Of interest to the FEHBlog is this OPM goal:

Improve customer experience by making it easier for Federal employees, annuitants, and other eligible persons to make a more informed health insurance plan selection. 

By September 30, 2023, complete user-centered design and develop a minimum viable product for a new, state-of-the-art Decision Support Tool that will give eligible individuals the necessary information to compare plan benefits, provider networks, prescription costs, and other health information important to them and their families.

Federal News Network tells us about a related Office of Management and Budget analytical perspective on federal workforce issues.

The Office of Management and Budget, in one of its analytical perspectives supplementing the Biden administration’s 2024 budget request, said federal workers’ pay is “increasingly hamstrung” by statutory requirements “that curb the ability of agencies to reward talent, including for specialized occupations, in a national competitive job environment.”

From the Rx coverage front —

The Wall Street Street Journal reports

Eisai Co.’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year. 

Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.

An estimated 167,954 veterans receiving care through the VA have Alzheimer’s dementia, according to government estimates. To qualify for Leqembi, patients must be over 65, have early-stage symptoms and elevated brain amyloid, sticky protein fragments, which the drug is designed to remove.

STAT News describes the VA’s step as “unexpected,” which is an understatement because CMS does not plan to issue a Medicare national coverage decision until mid-year. STAT News adds

The [VA] published a guide on its formulary saying coverage will extend to any veteran who meets specified criteria, including an MRI scan within the previous year, amyloid PET imaging consistent with Alzheimer’s and a staging test indicating mild Alzheimer’s dementia. There is also a long list of criteria that would exclude veterans.

The agency can negotiate prices for drugs, but the price it will pay for Leqembi was not listed and the Eisai spokesperson did not offer a cost. Leqembi has an annual wholesale price of $26,500, although the Institute for Clinical and Economic Review recently said the treatment should cost between $8,900 and $21,500 per year to be considered cost effective.

Under federal law, the VA can bill other health plans (including FEHB but not Medicare) for non-service related care such as this drug. For this reason, this VA action opens the back door to FEHB coverage of Leqembi.

From the end of the public health emergency front —

The Society for Human Resource Management offers its take on how employers should prepare for the end of the PHE, now less than two months away.

The American Hospital Association points out

The Food and Drug Administration will end 22 COVID-19-related policies when the public health emergency ends May 11 and allow 22 to continue for 180 days, including temporary policies for outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective equipment practices for sterile compounders not registered as outsourcing facilities, the agency announced. FDA plans to retain 24 COVID-19-related policies with “appropriate changes” and four whose duration is not tied to the PHE, including its recently revised policy for COVID-19 tests

From the Rx business front —

BioPharma Dive informs us

Pfizer has agreed to buy Seattle-based Seagen for $43 billion in a blockbuster deal that would unite the pharmaceutical giant with a biotechnology company that pioneered a new type of tumor-killing medicine.

The acquisition is the largest Pfizer has attempted since its 2009 purchase of Wyeth, and is the most sizable in the drug industry by value since AbbVie’s $63 billion buyout of Allergan in 2019.

Acquiring Seagen gives Pfizer control of the top-selling lymphoma medicine Adcetris as well as a pipeline of cancer treatments that’s yielded three new drug approvals in the past three years. Seagen specializes in a type of cancer therapy known as an antibody-drug conjugate, and has steadily improved on the technology since its founding in 1997.

STAT News relates

Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion.

The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.

The French pharma giant will now own TZield outright, paying $25 per share to acquire Provention — a 273% premium over Friday’s closing stock price.

In recognition of Patient Safety Awareness Week

  • The HHS Agency for Healthcare Quality and Research’s Director Robert O. Valdez, Ph.D., M.H.S.A. explains how AHRQ is sharpening its focus on diagnostic safety.
  • Beckers Hospital Review reports
    • The pediatric mental health crisis is the most pressing patient safety concern in 2023, the Emergency Care Research Institute said on March 13. 
    • The ECRI, which conducts independent medical device evaluations, annually compiles scientific literature and patient safety events, concerns reported to or investigated by the organization, and other data sources to create its top 10 list.
    • Here are the 10 patient safety concerns for 2023, according to the report: 
      • 1. The pediatric mental health crisis
      • 2. Physical and verbal violence against healthcare staff
      • 3. Clinician needs in times of uncertainty surrounding maternal-fetal medicine
      • 4. Impact on clinicians expected to work outside their scope of practice and competencies
      • 5. Delayed identification and treatment of sepsis
      • 6. Consequences of poor care coordination for patients with complex medical conditions
      • 7. Risks of not looking beyond the “five rights” to achieve medication safety
      • 8. Medication errors resulting from inaccurate patient medication lists
      • 9. Accidental administration of neuromuscular blocking agents
      • 10. Preventable harm due to omitted care or treatment
  • The U.S. Department of Labor announced on March 10
    • the launch of a series of online dialogues to gather ideas and other public input on how health policies can support workers’ mental health most effectively.
    • The crowdsourcing will focus on four areas of concern for people with mental health conditions, including benefits policies that meet their needs, access to workplace care and supports, the reduction of related social stigmas, disparities faced by people in underserved communities, shortages of behavioral health professionals, and the establishment of state resource systems.
    • Part of the department’s ePolicyWorks initiative, the dialogues will remain open until April 3. Input received will inform the next meeting of the Mental Health Matters: National Task Force on Workforce Mental Health Policy
  • Healthexec calls attention to FDA recalls of certain eyedrops.

From the value-based care front, Health Payer Intelligence notes

CareFirst BlueCross BlueShield (CareFirst) has formed a strategic alliance with Aledade, Inc. (Aledade), offering independent primary care physicians tools and resources to improve healthcare affordability and effectiveness, supporting CareFirst member physicians in achieving value-based care goals.

Through this value-based relationship, CareFirst member physicians can leverage specialists, including onsite business support for physician practices, a technology platform that works with more than 100 different EHRs, and healthcare regulatory and policy expertise.

From the medical debt front, Healthcare Dive reports

  • Hospitals are a prime source of medical debt in America that hits underserved populations hardest, despite charity care programs and financial assistance policies, according to a new analysis from the Robert Wood Johnson Foundation.
  • Of the 15% of U.S. adults with past-due medical debt, almost two-thirds owe some or all of that debt to hospitals, according to research from the Urban Institute. That medical debt disproportionately affects underserved populations, such as low-income individuals and people with disabilities, researchers found.
  • While medical debt remains a persistent financial burden in the U.S., a new analysis from the Urban Institute highlights how targeting hospital billing could ameliorate the problem.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the U.S. healthcare business front, the Wall Street Journal reports

Amazon.com Inc. will be able to close its purchase of 1Life Healthcare Inc., the operator of the One Medical line of primary-care clinics, without a legal challenge by antitrust enforcers.

The Federal Trade Commission won’t sue in time to block the $3.9 billion deal, including debt, but will continue its investigation of the merger, an agency spokesman said. The decision clears a path for Amazon to substantially expand its healthcare offerings and operate physical medical clinics. Amazon has invested in the healthcare space for years, including with an online pharmacy and other health ventures.

“The FTC’s investigation of Amazon’s acquisition of One Medical continues,” FTC spokesman Douglas Farrar said. “The commission will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.”

Becker’s Hospital Review offers two articles on Mark Cuban’s Cost Plus Drug Co.

  • In one article, BHR observes
    • As news outlets, celebrities, swingers on Reddit and people on Twitter praise Cost Plus Drug for its low prices on hundreds of generics, some of its products are more expensive than options at local pharmacies, KHN reported using GoodRx data. 
    • For example, one presentation of amoxicillin-clavulanate, an antibiotic currently in shortage, is $267.60 at Cost Plus Drug Co. and $109.44 at the average community pharmacy. 
    • Mr. Cuban told the outlet that its analysis was not comprehensive because of the company’s pricing model, which is a 15 percent markup, $3 for labor per drug and $5 for shipping. Because the shipping cost is overall and not for each medication, Mr. Cuban said his pharmacy can still offer a cheaper sale. 
  • In the other article, BHR informs us that the Cost Plus Drug Co., which already has business arrangements with three prescription drug managers, is contacting independent pharmacies for business.

From the public health front, February is Low Vision Awareness Month.

  • The BrightFocus Foundation proclaimed
    • Global vision and brain research non-profit BrightFocus Foundation celebrates the U.S. Food and Drug Administration’s (FDA) approval of Syfovre (pegcetacoplan injection), the first-ever treatment to slow the progression of vision loss from geographic atrophy, an advanced form of dry age-related macular degeneration and a leading cause of blindness. 
    • “Today’s FDA approval of Syfovre provides hope to the more than five million people worldwide who are at risk of permanent vision loss from geographic atrophy,” said BrightFocus President and CEO Stacy Pagos Haller. “This first-of-its-kind treatment is a momentous step forward in vision research and will make a meaningful difference in the lives of millions of people.” 
    • An estimated one million people in the U.S. have geographic atrophy, an advanced and severe form of age-related macular degeneration in which regions of cells in the retina waste away and die (atrophy). This progressive and irreversible disease can lead to permanent vision loss. Nearly 20 million adults in the U.S. have some form of age-related macular degeneration (AMD), almost double the previous estimate of 11 million people, according to a new report.    
    • People living with geographic atrophy often experience emotional hardships including anxiety, feeling powerless, and frustration. Approximately one in three have recently withdrawn from their social lives because of their disease, and BrightFocus offers a free AMD community group and educational audio chats for affected individuals.
    • Syfovre is expected to be available by the beginning of March through select specialty distributors and specialty pharmacies nationwide.

The New York Times Morning column criticizes the public health system for undertreating people with opioid use disorder, obesity and mental health issues, among other problems.

Similarly, HHS’s Agency for Healthcare Research and Quality calls attention to the underuse of cardiac rehabilitation in our country.

From the Rx coverage front —

  • BioPharma Dive explains that while the last decade’s lapse of patents impacted blockbuster small-molecule drugs, this decade’s lapse impacts specialty drugs such as Humira and Keytruda. Time will tell whether patients will convert to biosimilar drugs as quickly as they converted to generic drugs when patents lapse.
  • STAT News reports on “A battle between Vertex and insurers [over copay assistance accumulators] is leaving cystic fibrosis patients with crushing drug costs. Copay assistance accumulators prevent co-pay assistance from accumulating toward the plan’s out-of-pocket payments maximum required by the Affordable Care Act.
  • The Institute for Clinical and Economic Research related a final evidence report on treatments for multiple sclerosis.

From the medical research front, STAT News reports

An experimental antibody that delivers lethal radiation directly to the bone marrow improved the outcomes of stem cell transplants for older patients with relapsed leukemia — and may change the way transplant medicine is practiced.

The antibody-radiation treatment, called Iomab-B, is being developed by Actinium Pharmaceuticals, a small drugmaker based in New York.

In the results of a Phase 3 clinical trial presented Saturday, 22% of patients with acute myeloid leukemia who were administered Iomab-B to prepare their bone marrow for transplants had durable remissions lasting six months or more. None of the patients in the study who received conventional care prior to transplant achieved durable remissions.

Amazing.

From the miscellany / tidbits department

  • The U.S. Preventive Services Task Force proposes to renew the following Grade A recommendation:
    • The USPSTF recommends that all persons planning to or who could become pregnant take a daily supplement containing 0.4 to 0.8 mg (400 to 800 μg) of folic acid.
    • The public comment period on this renewal is open until March 20, 2023/
  • Beckers Payer Issues reports
    • Anthem BCBS ColoradoIndianaMissouri and Nevada are rolling out virtual primary care to more members.
    • Eligible commercial members will gain access to a virtual care team that conducts an initial health screening, creates a personalized care plan, and then provides care services, according to a Feb. 7 news release.
    • The virtual care services will take place through Anthem’s app, Sydney Health. The app offers 24/7 medical text chat, preventive wellness visits, support services, including new prescriptions and refills, and in-network referrals.
    • Virtual primary care is now available to eligible individuals enrolled in Anthem’s fully insured plans and certain large group administrative services clients.

Happy Days are Here Again!

OPM Headquarters a/k/a the Theodore Roosevelt Building

The FEHBlog was delighted to read today that OPM is encouraging FEHB carriers that OPM is encouraging FEHB carriers to incorporate Medicare Part D EGWPs in their plans for 2024. The FEHBlog has been encouraging this step for years, as readers must know.

The Medicare Part D EGWPs will cushion the FEHBP against the expenses of drugs to treat Alzheimer’s Disease and other illnesses that impact annuitants over age 65. While there are many factors at play in determining premiums, this factor standing alone would lower premiums. Thank you, OPM.

From the Omicron and siblings front, the New York Times virus briefing newsletter wished its readers well today.

Now, after three years, we’re pausing this newsletter. The acute phase of the pandemic has faded in much of the world, and many of us have tried to pick up the pieces and move on. We promise to return to your inbox if the pandemic takes a sharp turn. But, for now, this is goodbye.

The American Hospital Association informs us

In a study released today by the Centers for Disease Control and Prevention [CDC}, a single bivalent COVID-19 vaccine booster provided additional protection against omicron XBB variants in adults who previously received two to four monovalent vaccine doses. XBB-related variants account for over half of currently circulating COVID-19 variants in the United States.

“All persons should stay up to date with recommended COVID-19 vaccines, including receiving a bivalent booster dose when eligible,” the authors conclude.

and

The CDC yesterday launched a website to help consumers locate no-cost COVID-19 testing through its Increasing Community Access to Testing program, which includes pharmacies, commercial laboratories and other sites that bill the tests to government and private insurers and focus on vulnerable communities. The tests may include laboratory-based nucleic acid amplification tests and rapid antigen point-of-care tests, with results typically provided in 24-48 hours.

From the public health front

  • The Hill tells us about a CDC internal reorganization.
  • The HHS Agency for Healthcare Quality and Research provides us with an infographic and report about the three most commonly treated illnesses among older adults — hypertension, hyperlipidemia, and arthritis / other joint disorders
  • Fierce Healthcare relates, “The Biden administration is planning to release three to four new payment models on advance primary care and another enabling states to assume the total cost of care for Medicare, a top official shared.”
  • HHS’s HEAL Program Director, Dr. Rebecca Baker, discusses “Research That Offers Hope to End Addiction Long-Term.”

From the U.S. healthcare business front

Healthcare Dive reports

Elevance Health, one of the nation’s largest insurers, added more members in 2022, fueled by growth in its government business thanks to continued relaxed eligibility rules on enrollment.  

Elevance ended the year covering 47.5 million people, a nearly 5% increase from the prior-year period, driven largely by growth in Medicaid members.

In turn, total revenue climbed 13% to nearly $157 billion for the year as the insurer collected higher premium revenue from its Medicaid plans.   

Net income dipped about 1% to $6 billion for the full year as expenses climbed about 14%.  

and

The CMS announced Wednesday that a record-breaking 16.3 million people signed up for Affordable Care Act marketplace plans during the 2023 open enrollment season, a result of extended pandemic-era subsidies enacted by the American Rescue Plan.

Over 1.8 million more people enrolled in marketplace coverage compared to last year — a 13% increase, and the most amount of plan selections of any year since the launch of the ACA marketplace a decade ago, according to the CMS. The record-breaking enrollment numbers include 3.6 million first-time marketplace enrollees.

STAT News tells us

The claims have become almost ubiquitous. Hospital CEO after hospital CEO stands at a podium and promises the merger being announced will improve quality and lower costs.

Once deals close, though, there tends to be little, if any, follow-up to determine whether those things actually happened. A new Journal of the American Medical Association study adds to the growing body of evidence that they don’t. The authors looked across a large swath of the country’s hospitals and physicians found that while quality did improve marginally, the prices paid for services delivered by health system hospitals and doctors was significantly higher than their non-system peers.

“You start to feel really hopeful when you hear about this, ‘Yeah, we can really improve health care,’ and then when you look at it, it’s just not there,” said Nancy Beaulieu, a study author and research associate in Harvard Medical School’s department of health care policy.

Ruh roh.

On related note, Fierce Healthcare informs us

A top insurance lobbying group plans to press Congress this session to adopt legislation that expands the footprint of site-neutral payment reform, setting up a likely clash with hospital groups. 

The Blue Cross Blue Shield Association (BCBSA), which represents 38 Blues plans, released several policy priorities for the current Congress as part of a new report Tuesday. Some of the policies focus on changing Medicare reimbursement rates to pay the same amount to clinics whether they are independent or affiliated with a hospital. Other reforms focus on prescription drugs and spurring more participation in value-based care. 

“We’re very concerned about the increasing acquisition of physician practices by hospitals in the healthcare system,” said Kris Haltmeyer, vice president of policy analysis for BCBSA, during a reporter briefing Tuesday. 

One of the association’s major priorities is to pass a bill that would remove a grandfathering provision in the 2015 Balanced Budget Act. The provision shielded certain hospital outpatient departments from billing limits established in the law, with the exception of emergency departments. 

The association also wants to require off-campus hospital sites to get a different national provider identifier than the main facility campus. They should also use a different claim form for any professional service rendered in an office or clinic owned by a hospital but not on the campus. 

Go get ’em.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From our Nation’s capital, the Wall Street Journal reports

The Treasury Department began taking special measures to keep paying the government’s bills on Thursday as the U.S. bumped up against its borrowing limit, kicking off a potentially lengthy and difficult debate in Congress over raising the debt ceiling

With the federal government constrained by the roughly $31.4 trillion debt limit, the Treasury Department began deploying so-called extraordinary measures. Those accounting maneuvers, which include suspending investments for certain government accounts, will allow the Treasury to keep paying obligations to bondholders, Social Security recipients and others until at least early June, the department said last week.  

That gives lawmakers on Capitol Hill and the Biden administration roughly five months to pass legislation raising or suspending the debt limit. In a letter to congressional leaders on Thursday, Treasury Secretary Janet Yellen said there was “considerable uncertainty” about how long extraordinary measures can last. 

“I respectfully urge Congress to act promptly to protect the full faith and credit of the United States,” Ms. Yellen said. 

From the OPM front, OPM issued “Guidance on Increasing Opportunities for Federal Internships, Fellowships, and Other Early Career Programs” and, according to MeriTalk, held a “virtual job fair organized today by Tech to Gov in partnership with the Office of Personnel Management (OPM) is targeting a wide range of Federal government technology and related positions as part of the government’s goal to restock its tech ranks amid a slowdown in hiring by the private sector.” As daily reports of layoffs at tech companies have been appearing in the news, OPM’s timing for the job fair is opportune.

Today, benefits expert Tammy Flanagan completed her three Govexec columns on federal employee and annuitant benefit changes for this year.

From the Omicron and siblings front,

MedPage Today tells us, “Real-World Data Support Bivalent COVID-19 Boosters in Older Adults — Study from Israel showa ed high level of protection in people 65 and up.” MedPage Today’s medical editor in chief Dr. Jeremy Faust comments

[T]he Israeli data really helps us understand that for 65-years-olds and over, getting a bivalent booster is going to protect against hospitalization. We don’t know how long that’s going to last, and that’s the key. If it turns out that the bivalent booster ends up having a much longer tail of effectiveness than the monovalent did, that’ll be good news, but it’ll depend upon what variants are circulating and other factors, but we are watching that.

Reuters adds

The European Union’s drug regulator has not identified any safety signals in the region related to U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech’s updated COVID-19 shot, the agency said on Wednesday.

On Friday, the U.S. Food and Drug Administration and the Centres for Disease Control and Prevention said that a safety monitoring system had flagged that the shot could possibly be linked to a type of brain stroke in older adults, according to preliminary data.

The FDA’s Vaccines and Related Biological Products Advisory Committee will consider this safety issue at a meeting on January 26.

Also from the FDA front, the Wall Street Journal informs us

U.S. drug regulators rejected Eli Lilly & Co.’s proposed new Alzheimer’s disease treatment, saying they need more data from clinical testing, according to the company.

The setback could delay a potential commercial introduction of the highly anticipated drug by at least several months, if the Food and Drug Administration eventually decides to approve it. * * *

The agency had recently approved another Alzheimer’s therapy. Earlier this month, the FDA gave early approval to a new Alzheimer’s drug from Eisai Co. and Biogen Inc.

Lilly had been hoping for an accelerated FDA approval of donanemab early this year. Now, a midyear filing of a standard drug application means an FDA decision could be pushed back into 2024, based on typical FDA timelines of taking six to 10 months to review new drug applications.

The American Hospital Association relates

In an online survey last November of 1,200 U.S. adults previously vaccinated against COVID-19, 62% had not yet received a bivalent booster dose, most often because they did not know they were eligible or the booster was available, or believed they were immune against infection, the Centers for Disease Control and Prevention reported today. After viewing information about eligibility and availability, over two-thirds of them planned to get a bivalent booster and 29% reported receiving the booster in a follow-up survey in December. To help increase bivalent booster coverage, the report recommends using evidence-based strategies to inform patients about booster recommendations and waning immunity.

From the No Surprises Act front, Healthcare Dive points out

  • Many Americans are still exposed to the potential for a surprise medical bill from an out-of-network ambulance ride, a research report published in Health Affairs found. About 28% of emergency trips in a ground ambulance resulted in a potential surprise bill, according to the research that analyzed commercial insurance claims.
  • About 85% of emergency transports were deemed out of network between 2014 and 2017, researchers found. But two-thirds of those trips are paid in full by insurers, eliminating the risk of a surprise bill.
  • The report shows the difference in pricing by ground ambulance ownership and how that affects patients’ financial exposure. * * *
  • Given the high prevalence for a potential surprise bill, protections like those afforded to consumers in the No Surprises Act may be necessary for both emergency and non-emergency transports, the authors said.

The FEHBlog is puzzled by the author’s extension of NSA protection to non-emergency transports, which the consumer should have time to manage. Congress should not overload the NSA system.

From the telehealth front, Healthcare Dive reports

  • Private insurers paid roughly the same for telehealth and in-person visits during the early days of the COVID-19 pandemic as virtual care surged, according to new research from the Kaiser Family Foundation.
  • Though it’s unclear how payment rates might have changed over the past two years, the findings call into question the argument that telehealth is saving the healthcare system money, researchers said.
  • However, researchers said that perks of telehealth included expanded access and convenience — cost benefits of which were not factored into the study.

Fierce Healthcare tells us

UnitedHealthcare is rolling out a new virtual behavioral health coaching program backed by Optum.

The offering is available as of Jan. 1 for 5 million fully insured members, and self-insured employers can purchase the program as an employer benefit. Through the program, adults with symptoms of mild depression, stress and anxiety can access support for their mental health needs through virtual modules as well as one-on-one video conferences, phone calls or messaging with coaches. * * *

Members who use virtual coaching can connect with a dedicated behavioral health coach for a 30-minute weekly audio or video call and can chat with their coach using in-app messaging between sessions.

The program lasts eight weeks, and each member will complete an assessment at the onset to identify their individual needs. Coaches use cognitive behavioral therapy techniques to assist the patient in crafting an action plan that is personalized to them.

In other UHC news, Beckers Payer Issues relates

The largest employer of physicians in the United States is not HCA, the VA, or Kaiser Permanente — it’s UnitedHealth Group’s Optum.

With at least 60,000 employed or aligned physicians across 2,000 locations in 2023, Optum has cemented itself at the forefront of the quickly changing healthcare delivery landscape. For comparison, Bloomberg reported in 2021 that Ascension employs or is affiliated with 49,000 physicians, HCA has 47,000 and Kaiser has 24,000.

Given that the Affordable Care Act limits health insurers, but not healthcare providers, profits, UHC made a smart move, in the FEHBlog’s opinion.

From the Rx coverage front, STAT News tells us

In a bid to blunt competition and address rising drug costs, Sanofi is offering a warranty that will cover the cost for any hospital if a specific medicine fails to work, marking only the second time a major pharmaceutical company has taken such a step.

In this instance, Sanofi designed a warranty program for its Cablivi medication, which is used to treat aTTP, a rare, life-threatening autoimmune blood disorder that is considered a medical emergency. The cost will be refunded for up to six doses for patients who fail to initially respond or up to 12 doses for patients whose condition worsens.

The move comes after Pfizer began offering warranties for two of its medicines, the first of which debuted in August 2021. At the time, the Pfizer effort was the first of its kind in the pharmaceutical industry. Unlike the Sanofi warranty, however, the Pfizer programs offer refunds to patients — not hospitals — if the medicines fail to work sufficiently.

Although the approaches vary, both companies are signaling their interest in differentiating themselves from competitors, not just responding to complaints about the rising cost of medicines, according to Emad Samad, president of Octaviant Financial, a firm that is promoting the use of warranties in the pharmaceutical industry.

How would these warranties redound to the benefit of third party payers?

From the miscellany front

  • Cigna offers a paper about “Digging into the Unique Drivers and Healthy Behaviors That Impact Vitality.”
  • The U.S. Preventive Services Task Force released a chart of its most impactful 2022 recommendations.
  • Fierce Healthcare reports, “The number of providers serving as [Medicare] accountable care organizations increased slightly this year thanks to the start of a new advanced model and a slew of reforms meant to reverse a slide in participation.”
  • Mercer Consulting digs into “must do” valued based care strategies.
  • The MIT Technology Review considers the prospect of gene editing for the masses using CRISPR 3.0
  • STAT News discusses the “hot mess” of legal issues associated with the FDA’s recent decision to make abortion drugs available at pharmacies.