Weekend update

CDC

Weekend update

David Ermer–CDC, Congress, Medical / Rx research, Mental health care, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The lede item necessarily is this Fortune Well warning dated August 13

  • “Patients who take blockbuster drugs like Wegovy or Ozempic for weight loss may face life-threatening complications if they need surgery or other procedures that require empty stomachs for anesthesia. This summer’s guidance to halt the medication for up to a week may not go far enough, either.
  • “Some anesthesiologists in the U.S. and Canada say they’ve seen growing numbers of patients on the weight-loss drugs who inhaled food and liquid into their lungs while sedated because their stomachs were still full — even after following standard instructions to stop eating for six to eight hours in advance.”
  • The drugs can slow digestion so much that it puts patients at increased risk for the problem called pulmonary aspiration, which can cause dangerous lung damage, infections and even death, said Dr. Ion Hobai, an anesthesiologist at Massachusetts General Hospital in Boston.
  • “This is such a serious sort of potential complication that everybody who takes this drug should know about it,” said Hobai, who was among the first to flag the issue.

From the healthcare policy front —

  • Congress is on a State/District work break this week. There are no out-of-town hearings scheduled.
  • NPR Shots predicts that a recently proposed rule will improve hospital price transparency. Fingers crossed.

From the public health front –

  • Fortune Well identifies and explains the four daily habits of “truly happy” people.
  • The Drug Enforcement Administration’s public education website explains the dangers of
    • “Xylazine – often called “tranq” – is a drug adulterant that DEA has detected in a growing number of overdose deaths, despite the FDA authorizing it only for veterinary use.
    • “Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.”
  • Cardiovascular Business points out that,
    • “The U.S. Food and Drug Administration (FDA) has announced that Datascope, a subsidiary of Getinge, is recalling certain Cardiosave intra-aortic balloon pumps (IABPs) due to a risk that the devices could stop working unexpectedly. This is a Class I recall, which means the FDA believes using one of these IABPs “may cause serious injuries or death.” 
    • “These devices are designed to provide temporary support to a patient’s left ventricle. Electrical failures have caused some of them to turn off with no warning, however, putting the patient’s health at immediate risk. 
    • “Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death,” according to the FDA’s advisory.”
    • This is the fourth cardiac care device to be recalled in 2023.
  • mHealth Intelligence says that “Using survey data on patient attitudes toward mental health services and depression screening, a new study indicated that Black American Women are comfortable with using voice or video calls to communicate with mental health providers.”
  • Patient Engagement HIT informs us,
    • Only a fifth of the nearly 2.5 million adults with opioid use disorder received medication for the disease 2021, leaving millions without access to addiction treatment, according to new data from the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC).
    • The report, published as a research note in JAMA Network Open, also showed sociodemographic health disparities in opioid use disorder treatment access, with Black people, women, individuals who were unemployed, and those in non-metropolitan areas being less likely to receive treatment.
    • The study looked particularly at medication-assisted treatment, or MAT, which is considered the gold standard in OUD therapy. Drugs like buprenorphine, methadone, and naltrexone have all proven effective for OUD treatment.

In early medical/drug research news,

  • Precision Vaccinations reports
    • While the U.S. government has recently licensed monoclonal antibody therapies (LEQEMBI®), anti-amyloid vaccines may offer a convenient, affordable, and accessible means of preventing and treating Alzheimer’s Disease (AD).
    • The Lancet’s eBioMedicine recently published a paper that concludes that an immunotherapeutic vaccine candidate targeting toxic forms of aggregated beta-amyloid in the brain to treat and prevent AD.
    • Published on July 29, 2023, this research paper concludes Vaxxinity, Inc. UB-311 is an active immunotherapy, “was safe and well-tolerated,” with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer’s disease (AD).
    • And UB-311 could offer multiple competitive advantages over licensed passive immunotherapies, including less frequent dosing, a more convenient mode of administration, improved accessibility, and cost-effectiveness.

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “Federal spending on Medicare Advantage bonus payments has risen every year since 2015, and will reach at least $12.8 billion this year — an increase of nearly 30% from 2022, according a new KFF analysis.
    • “Rapid growth in bonus payments has implications for Medicare spending and beneficiary premiums, especially since spending on the bonuses has grown faster than MA enrollment overall, researchers said.
    • “UnitedHealthcare — the biggest MA insurer — will receive the largest total payments at $3.9 billion. Kaiser Permanente has the highest per-enrollee bonuses at $523.”
  • and
    • “The Department of Justice is requesting more data from Amedisys regarding its proposed $3.3 billion acquisition by UnitedHealth, a move that will push back the timeline of the deal.
    • “The home health and hospice provider disclosed in a filing with the SEC on Thursday that it received a second request for information from regulators on August 4 regarding the merger.
    • “UnitedHealth announced plans to acquire Amedisys in June, after the Louisiana-based provider reneged on an existing merger agreement with Option Care Health.”

Monday Roundup

David Ermer–CDC, CMS, COVID-19, Federal employment benefits, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • Fedscoop reports
    • “The Office of Personnel Management is expecting to conduct a four-month trial of a new online retirement application platform for federal employees later this year, FedScoop has learned.
    • “In a letter to lawmakers, which was obtained by this publication through a Freedom of Information Act request, agency director Kiran Ahuja said OPM will conduct an approximately 120-day pilot in coordination with the National Finance Center, which is a federal agency division under the United States Department of Agriculture.
    • “Responding to questions from lawmakers, including Sen. Dick Durbin, D-Il., Ahuja wrote: “Between the electronic employee data received from the payroll center and the online retirement application, RS will receive all the information necessary to process a retirement application electronically.”
    • “She added: “The pilot will likely last 120 days, at which point RS will evaluate the results and determine the appropriate next steps to expand the program.” 
  • The Federal Times says that “Unions representing more than 900,000 federal workers are pushing back against President Joe Biden’s plan to bring back more in-person work for federal employees, citing contract terms and the benefits of a hybrid workforce.”
  • The FEHBlog had time today to redline the proposed amendments to the mental health parity rule in the existing rule, 45 C.F.R. Sec. 146.136. The FEHBlog thought that the proposed amendment would downplay the complicated non-quantitative treatment limitation (NQTL) provisions in favor of more direct requirements to improve access to, and lower costs for, mental health and substance use disorder care. Au contraire, the regulators seek to achieve these goals via the NQTL rules, which will become hyper-complicated. It’s disappointing, considering that parity could be achieved much more efficiently by covering medical/surgical and mental health/substance use disorder care under a unified set of rules.

From the public health front —

  • U.S. News and World Report informs us
    • A new coronavirus strain has taken over as the top variant circulating in the U.S.
    • EG.5 was responsible for more than 17% of new coronavirus cases over the past two weeks, according to data from the Centers for Disease Control and Prevention. That’s the highest prevalence of any strain circulating, rising above the so-called “arcturus” variant, which caused nearly 16% of infections. * * *
    • XBB.1.5, which will be the target of the updated COVID-19 vaccines coming in the fall, is decreasing in the U.S. Still, health experts say that the shot should work on other omicron subvariants as well.
    • Health officials hope that the upcoming fall booster campaign will increase protection against the coronavirus ahead of a potential fall and winter wave.
  • Reuters points out
    • “Five major U.S. health systems said they would offer Eisai and Biogen’s promising new Alzheimer’s drug Leqembi after working out payment and administrative policies, and how to assess and monitor patients, most likely in the next month or two.
    • “Leqembi, which won full U.S. regulatory approval last month, is the first treatment proven to slow progression of the mind-robbing disease for people in the earliest stages of Alzheimer’s.
    • “The disease affects an estimated 6.5 million people, most of whom are part of the U.S. government’s Medicare plan for people 65 and older.
    • “The patients are lining up. They want to be treated, but it’s difficult to rush right into it,” said Dr. James Galvin, who heads the Alzheimer’s research program at the University of Miami Miller School of Medicine.
    • “Neurologists at the Mayo Clinic in Rochester, Minnesota, Chicago’s Northwestern Memorial and Los Angeles’ Cedars-Sinai all said they plan to roll out the drug in the next few months. Cleveland Clinic and Utah’s Intermountain health system said they have not started offering it.”
  • Per Health Day,
    • “By age 75 years, approximately half the global population can expect to develop a mental disorder, according to a study published online July 30 in The Lancet Psychiatry.
    • “John J. McGrath, Ph.D., from Queensland Centre for Mental Health Research in Brisbane, Australia, and colleagues used data from 156,331 adult participants in the World Mental Health surveys (2001 to 2022; 29 countries) to estimate age-of-onset distributions, lifetime prevalence, and morbid risk for mental disorders.
    • “The researchers found that the lifetime prevalence of any mental disorder was 28.6 percent for male respondents and 29.8 percent for female respondents. By age 75 years, the morbid risk for any mental disorder was 46.4 percent for male respondents and 53.1 percent for female respondents. At 15 years, the conditional probabilities of first onset peaked, with a median age of onset of 19 years for male respondents and 20 years for female respondents. Alcohol use disorder and major depressive disorder were the two most prevalent disorders for male respondents, while major depressive disorder and specific phobia were most prevalent for female respondents.”

From the No Surprises Act front

  • According to Healthcare Dive,
    • “A Texas judge has vacated portions of the No Surprises Act dispute resolution process after the state’s medical group argued it was illegal and overly favorable to health insurers, leading the HHS to once again suspend arbitrations until further notice.
    • “Judge Jeremy Kernodle for the Eastern District of Texas on Thursday vacated regulators’ increase of the dispute resolution administrative fee to $350 and the “batching rule,” which allowed arbitration processes only on claims with the same service code.
    • “The judgment removes barriers for providers to file dispute resolution claims and will likely increase the volume of claims, especially from physician groups and hospital outpatient departments, according to a health lawyer.”
  • CMS adds
    • Effective August 7, 2023, the Departments have directed certified IDR entities to resume processing single and bundled disputes where the administrative fees have been collected (or the deadline for collecting fees expired) before August 3, 2023. Additionally, the Departments have directed certified IDR entities to resume processing batched disputes where the IDR entity determined that the batched dispute was eligible and collected administrative fees (or the deadline for collecting fees expired) before August 3, 2023. Processing of other disputes remains temporarily suspended.
  • The federal government appealed one of Judge Kernodle’s decisions in favor of the Texas Medical Association and may appeal this one too. The FEHBlog has no problem with Judge Kernodle’s batching rule. He thinks that the regulators should ladder the administrative fee based on the sum of the QPAs in dispute. The higher the sum; the higher the fee. By the way, the government’s administrative fee is on top of the independent dispute entity’s fee, which runs from $400 to $500 fee per party.

In other U.S. healthcare business news —

  • Fierce Healthcare relates
    • “Large health systems are scooping up independent hospitals, and that consolidation negatively affects employers, insurers and patients, according to a new analysis backed by Blues giant Elevance Health.
    • However, the American Hospital Association was quick to dispute the findings, with CEO Rick Pollack telling Fierce Healthcare in an email that the analysis “draws absurd conclusions about the impact of healthcare systems on access to care, cost and quality.”
  • Beckers Payer Issues ranks health insurers by commercial membership here.
  • Beckers Hospital Review names three U.S. hospitals that announced shutdown plans last week.

Thursday Miscellany

David Ermer–ACA, AHRQ, CDC, COVID-19, FDA, Telehealth, U.S. Healthcare–

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

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.”

Thursday Miscellany

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

From Washington, DC —

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

From the public health front —

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

From the telehealth and artificial intelligence fronts, we learn from

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

From the U.S. healthcare business front

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

 

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

The FEHBlog hopes his readers enjoyed their Fourth of July weekend. The FEHBlog certainly did.

From Washington, DC —

  • FedWeek informs us
    • “The House version of the annual defense authorization bill would require DoD and OPM to conduct a “comprehensive review of the civilian workforce on FEHB to ensure that all family members and dependents who are currently receiving benefits are in fact eligible.”
    • “The language, inserted as an amendment to a bill that could come to floor voting in the upcoming weeks, would be the most concrete response to date regarding an issue that has been the subject of repeated warnings from OPM’s inspector general’s office and most recently from the GAO: ineligible persons being covered in the program as family members.”
  • FEHBlog note — The largest internal control problem with FEHB eligibility stems from the fact that OPM does not take advantage of the HIPAA 820 electronic enrollment roster, which allows health plan carriers to reconcile premium to headcount. For example, if the carrier finds via the HIPAA 820 that it is not receiving premiums on a self and family enrollee, then the outcome may be disenrolling the individual and their covered family members in a fair way. In the FEHBlog’s view, it does not make sense to move forward with a family member eligibility audit until the HIPAA 820 transaction is operational in FEHB. That is the most logical first step.
  • Federal News Network provides us with background on OPM’s new employee assistance program guidance. In the FEHBlog’s opinion, OPM should team up EAPs with FEHB plans in order to better coordinate their respective coverages.
  • Fedweek also explains for the benefit of federal and postal employees how to continue FEGLI coverage into retirement.
  • Healthcare Dive relates
    • “The CMS is proposing to cut Medicare reimbursements to home health agencies by 2.2% next year, or $375 million less than providers received in 2023, according to draft regulation released Friday. 
    • “The agency said the proposed rule includes a 2.7% payment bump that’s offset by a 5.1% cut related to the Patient-Driven Groupings Model, which aimed to better sort patients into different payment categories by clinical need and other factors.
    • “The reimbursement changes also reflect an estimated 0.2% increase due to an updated fixed-dollar loss ratio, according to regulators.”

From the public health front —

  • CBS News reports
    • “Nearly 1 in 4 U.S. adults and older teens had still not caught COVID-19 by the end of last year, according to new estimates from the Centers for Disease Control and Prevention, while 77.5% had antibodies from at least one prior infection. The figures are based on the final batch of results from the agency’s nationwide studies of antibodies in Americans ages 16 and up. * * *
    • “Virtually every American ages 16 and older — 96.7% — had antibodies either from getting vaccinated, surviving the virus or some combination of the two by December, the CDC now estimates. The study found 77.5% had at least some of their immunity from a prior infection. * * *
    • Rates were similar among men and women. Black and White people also have similar prior infection rates, between 75% and 80%. 
    • Among other racial and ethnic groups, Asian Americans had the smallest proportion of people with antibodies from a prior infection, at 66.1%, while Hispanic people had the highest, at 80.6%.

From the Rx and medical devices coverage front —

  • BioPharma Dive points out
    • “Moderna on Wednesday said it’s submitted applications to regulatory agencies around the world in a bid to win approval of a new vaccine to fight respiratory syncytial virus, or RSV, in older adults.
    • “The company filed with regulatory agencies in Europe, Switzerland and Australia and began a rolling submission to the U.S. Food and Drug Administration for the vaccine, which is currently known as mRNA-1345. Future applications are planned for other nations as well.
    • “Moderna’s submissions come two months after the FDA approved the first RSV vaccine, developed by GSK. The agency cleared a second RSV shot from Pfizer weeks later. Both products are approved for use in patients who are at least 60 years old, the same group Moderna aims to treat.”
  • Forbes reports
    • “On Wednesday, medtech giant Abbott announced that its new leadless pacemaker system, Aveir DR, has been approved by the FDA. This is the first time the FDA has given a thumbs up to a device of this type for two different chambers of the heart, which opens up this technology to nearly any patient who needs a pacemaker.
    • “From a clinical perspective, we know that leadless pacing offers a number of important advantages to patients in terms of getting away from the complications related to traditional pacemakers,” says Leonard Ganz, a cardiologist and Abbot’s chief medical officer for cardiac rhythm management. “This will expand the number of patients who can benefit from leadless pacing many, manyfold,” he tells Forbes.” * * *
    • “Although pacemakers have been life-changing for millions of people, they do carry downsides, explains Ganz, in particular, risk of infection both from the surgical procedure needed to implant them as well as the leads themselves should their insulation become compromised. Leadless pacemakers, by contrast, are much smaller, don’t require surgical implantation and have no wires connected to the heart. Instead, they are injected using a catheter in a vein and placed directly in the heart in a way that allows for removal if need be. All of these factors significantly reduce the risk of complications.
    • “The first leadless pacemaker, manufactured by Medtronic, was cleared by the FDA in 2016. Abbott’s first leadless pacemaker, the Aveir VR, was approved by the FDA in March 2022. [In contrast to the new Abbott device, b]oth of these products only work in a single chamber of the heart. About 80% of the patients that require a pacemaker need shocks in two cardiac chambers in order to keep the desired heart rhythm.”
  • The New York Times discusses “food noise,” which the new weight loss drugs dissipate.
    • “The active ingredient in Ozempic and Wegovy is semaglutide, a compound that affects the areas in the brain that regulate appetite, Dr. Gabbay said; it also prompts the stomach to empty more slowly, making people taking the medication feel fuller faster and for longer. That satiation itself could blunt food noise, he said.
    • “There’s another theoretical framework for why Ozempic might quash food noise: Semaglutide activates receptors for a hormone called GLP-1. Studies in animals have shown those receptors are found in cells in regions of the brain that are particularly important for motivation and reward, pointing to one potential way semaglutide could influence cravings and desires. It’s possible, although not proven, that the same happens in humans, Dr. Hwang said, which could explain why people taking the medication sometimes report that the food (and, in some cases, alcohol) they used to crave no longer gives them joy.”

From the U.S. healthcare business front

  • Segal Consulting delves into health plan prior authorization practices.
  • The Wall Street Journal reports that “Some hospitals that spent big on nurses during the pandemic are now short on cash; Distressed institutions are closing unprofitable services, selling assets to avoid default on debts.” Ruh-roh!
  • Forbes reports
    • “Rite Aid reported a quarterly loss of more than $306 million as the drugstore chain grapples with the loss of customers from its Elixir pharmacy benefits business as executives work to turn around the struggling drugstore chain.
    • “Rite Aid, which has closed more than 140 unprofitable stores in the last two years, reported a fiscal first-quarter loss of $306.7 million, or $5.56 per share, for the period ended June 3, 2023. That compares with a loss of $110.2 million, or $2.03 per share, in last year’s first quarter.”

From the fraud, waste, and abuse front, HealthTech explains how the Justice Department is using advanced analytics to combat healthcare fraud.

From the medical research front, the National Institutes of Health announced that “The first clinical trial of a three-month TB treatment regimen is closing enrollment because of a high rate of unfavorable outcomes with the investigational course of treatment.” The FEHBlog appreciates NIH’s transparency.

Friday Factoids

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Rx coverage–

On the day I return to Texas, the DC air quality improved from unhealthy to unhealthy for sensitive groups, all due to wildfire smoke. The air quality in Dripping Springs, TX, where the FEHBlog lives, is good.

Also from Washington, DC, the Supreme Court closed its October 2022 term today.

Politico tells us

  • “It’s CDC Director Rochelle Walensky’s last day at the agency, but she’s still thinking a lot about the agency’s work ahead.
  • “She’s been working to smooth potential bumps in a transition, in contact with her successor, Mandy Cohen — an Obama administration alum and formerly North Carolina’s top public health official.
  • “And she looks to stay in the game, telling Pulse she’s “eagerly wanting to champion health and public health from a new perch,” though she’s been vague about what that might be.”

The Department of Health and Human Services announced

  • “actions to lower health care costs and implement President Biden’s lower cost prescription drug law – the Inflation Reduction Act (IRA) – which is already saving covered seniors and people with disabilities hundreds of dollars annually.
  • “HHS released revised drug price negotiation guidance from the Centers for Medicare & Medicaid Services (CMS). The guidance is a critical step in implementing the IRA, which finally took on Big Pharma and will allow Medicare to negotiate lower drug prices on behalf of people with Medicare. * * * “
  • “HHS today also announced that President Biden’s cap on insulin costs at $35 per month will go into effect for people who get their insulin through Medicare Part B and Medicare Advantage with use of a traditional pump starting tomorrow, July 1, 2023. Millions of people with Medicare Part D are already benefiting from the Inflation Reduction Act’s $35 monthly cap on insulin costs, and if these rules for Part B and Part D had been in effect in 2020, 1.5 million beneficiaries would have saved an average of $500 per year.
  • “More information on the Medicare Drug Price Negotiation Program is available at https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation
  • “To read more on how the $35 insulin cap is already benefiting seniors and other Medicare enrollees across the country, visit: https://aspe.hhs.gov/reports/insulin-affordability-ira-data-point.”

From the public health front, MedPage Today informs us

  • “Drug overdose deaths with xylazine involvement have multiplied, with age-adjusted death rates 35 times higher in 2021 than in 2018, the CDC reported.
  • “The age-adjusted rate of drug overdose deaths involving the animal sedative, also known as “tranq,” rose from 0.03 per 100,000 people to 1.06 per 100,000, Merianne Rose Spencer, PhD, MPH, a researcher at the CDC’s National Center for Health Statistics in Hyattsville, Maryland, and co-authors reported in Vital Statistics Rapid Release. * * *
  • “While never approved for human use, xylazine has increasingly been found adulterating other drugs, particularly fentanyl. It slows breathing and heart rate, lowers blood pressure to unsafe levels, complicates efforts to reverse opioid overdoses with naloxone (Narcan), and can lead to serious flesh wounds.”

From the medical research front, the National Institutes of Health announced

  • “Insights into healing and aging were discovered by National Institutes of Health researchers and their collaborators, who studied how a tiny sea creature regenerates an entire new body from only its mouth. The researchers sequenced RNA from Hydractinia symbiolongicarpus, a small, tube-shaped animal that lives on the shells of hermit crabs. Just as the Hydractinia were beginning to regenerate new bodies, the researchers detected a molecular signature associated with the biological process of aging, also known as senescence. According to the study published in Cell Reports, Hydractinia demonstrates that the fundamental biological processes of healing and aging are intertwined, providing new perspective on how aging evolved.
  • “Studies like this that explore the biology of unusual organisms reveal both how universal many biological processes are and how much we have yet to understand about their functions, relationships and evolution,” said Charles Rotimi, Ph.D., director of the Intramural Research Program at the National Human Genome Research Institute (NHGRI), part of NIH. “Such findings have great potential for providing novel insights into human biology.”

From the healthcare spending front, Mercer Consulting explains what’s happening with the boatload of claims data that health plans began posting to their websites last year.

  • “It’s been almost a year since group health plan sponsors and issuers, in order to comply with the Transparency in Coverage final rule, posted machine-readable files (MRFs) that contain in-network negotiated charges for every medical service with every provider in their networks. This data had previously been considered by insurers as proprietary and confidential, but the government saw the need to put more data about the cost of healthcare into the hands of consumers. There have been eye-opening reports in the past revealing wide discrepancies in the price of medical services from one healthcare facility to the next; the hope was that making price data freely available would make these kinds of studies much easier to do. Given that the data has been available to the public since July 2022, why haven’t we seen more stories on the cost of healthcare in the United States? What happened to all that medical price data?
  • “Well, it’s certainly out there. By some estimates, over 700 terabytes of MRF data have been published since last summer. * * *
  • “While we’re excited about the possibilities for this price data, we’ll need to be patient as the market moves to put more of it to use. Importantly, this data also underpins the final leg of the transparency regulations, which requires real-time benefit cost estimators be made available to the public for 500 shoppable services this year and for everything else by 2024. So if you haven’t already, make sure your data partners are ready for this next step of compliance.
  • “While we are still a long way from achieving price transparency in health care, this data is a crucial starting point.”

From the Rx coverage front, BioPharma Dive discusses Biomarin Phamaceutical’s plans to market its FDA-approved hemophilia gene therapy in the U.S.

  • “BioMarin’s chief commercial officer, Jeff Ajer, told investors during a conference call Thursday afternoon that the first priority of the launch will be getting the country’s largest hemophilia treatment centers to use Roctavian. The FDA approved the therapy for certain people living with severe hemophilia A, a group that totals around 2,500 in the U.S. by BioMarin’s estimates.
  • “Like other approved gene therapies, Roctavian is expensive. BioMarin set its list price at $2.9 million, which Ajer said translates to net revenue of approximately $1.9 million. The company expects to record between $50 million and $150 million in Roctavian revenue this year. BioMarin is also tying the drug’s price to patient outcomes, promising a warranty that will reimburse insurers up to 100% if patients don’t respond, and a pro-rated rebate for the first four years if the response wanes.  
  • “But unlike most available gene therapies, Roctavian treats a disease with a variety of available options. BioMarin argues that its therapy would likely save the healthcare system money over time. Many hemophilia A patients are currently treated multiple times a week with “replacement Factor,” medicines that supply them with the key blood-clotting protein they’re missing. These treatments are costly too, at about $800,000 per year for the typical patient, according to BioMarin.”

Thursday Miscellany

David Ermer–CDC, FDA, Generative AI, HSA, Mental health care, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC, where the air quality index was code red today —

  • The Supreme Court is down to its final four pending decisions from the October 2022 term. The final decision day is tomorrow morning
  • The EEOC Chair made the following noteworthy comment on today’s Supreme Court decision on affirmation action in college admissions:
    • “Today’s Supreme Court decision effectively turns away from decades of precedent and will undoubtedly hamper the efforts of some colleges and universities to ensure diverse student bodies. That’s a problem for our economy because businesses often rely on colleges and universities to provide a diverse pipeline of talent for recruitment and hiring.  Diversity helps companies attract top talent, sparks innovation, improves employee satisfaction, and enables companies to better serve their customers”.
    • “However, the decision in Students for Fair Admissions, Inc. v. President & Fellows of Harvard College and Students for Fair Admissions, Inc. v. University of North Carolina does not address employer efforts to foster diverse and inclusive workforces or to engage the talents of all qualified workers, regardless of their background. It remains lawful for employers to implement diversity, equity, inclusion, and accessibility programs that seek to ensure workers of all backgrounds are afforded equal opportunity in the workplace.”
  • Govexec tells us
    • “The Supreme Court on Thursday ruled against the U.S. Postal Service in its attempts to require any employee to work on Sundays, even when it conflicted with their religious observances. 
    • “In a unanimous decision [interpreting Title VII of the Civil Rights Act of 1964], the top court reversed decades of precedent in determining that employers like USPS have to demonstrate more than a de minimis burden to avoid their otherwise mandated obligations to provide reasonable religious accommodations. The justices sent the case back to a lower court to determine whether, given the specifics of the case, the Postal Service could come up with other means to keep a letter carrier on the payroll without requiring him to work on Sundays.”

From the public health front —

  • The American Hospital Association informs us
    • “As proposed by its Advisory Committee on Immunization Practices, the Centers for Disease Control and Prevention [(CDC)] today recommended a single dose of the GSK or Pfizer Respiratory Syncytial Virus vaccine for people aged 60 and older who decide with their health care provider that the vaccine would benefit them. The Food and Drug Administration last month approved the vaccines for use in individuals 60 and older. The first U.S.-licensed vaccines to protect against RSV, they are expected to be available this fall.”
  • The CDC announced
    • “CDC Director Rochelle P. Walensky, M.D., M.P.H. adopted the 2023-2024 Advisory Committee on Immunization Practices’ (ACIP) recommendations on annual influenza (flu) vaccination for everyone 6 months and older in the United States on June 27, 2023.  There were small changes to the annual recommendations around flu vaccination, including an acknowledgement of the updated flu vaccine composition for the 2023-2024 flu season and a change in the recommendations for vaccination of people with egg allergies. Dr. Walensky’s adoption of the ACIP recommendations makes them official CDC policy. * * *
    • The recommended timing of flu vaccination has not changed. September and October are the best times for most people to get vaccinated.
  • The Department of Health and Human Services announced
    • “[Its] Office of the Assistant Secretary for Health (OASH) is releasing a draft framework to support and accelerate smoking cessation, building on supports that are already in place for people who want to quit. This framework will be a roadmap to enhance collaboration and coordination across HHS—and with federal and nonfederal stakeholders—to drive further progress toward smoking cessation and to deliver equitable outcomes for all persons in America. HHS is seeking public input on the framework before it is finalized.
    • “The public comment period will be open for 30 days starting June 30, 2023, through July 30 at 11:59 PM ET. HHS is committed to transparency and providing opportunities for public participation during the development of the Framework.
    • “Anyone can comment. Each responding entity (person or organization) is requested to submit only one response via email to HHSSmokingCessationFramework2023@hhs.gov as a Word document, Portable Document Format (PDF), or in the body of an email. Please include “Request for Information: Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation” in the subject line of the email message.”
  • The Society for Human Resource Management offers employers strategies for reducing record-level employee stress.
  • Roll Call reports
    • “Only one-third of individuals diagnosed with hepatitis C have been cured in the decade since cures for the disease became available, according to a study published Thursday from the Centers for Disease Control and Prevention.
    • “Hepatitis C is a viral inflammation of the liver that can be asymptomatic yet spread through blood or other bodily fluids. Without treatment, hepatitis C is a chronic condition that can lead to liver cancer, liver failure or other comorbidities. 
    • “The Food and Drug Administration approved the first highly effective direct-acting antiviral drugs to cure hepatitis C in 2013. Treatment occurs over the course of 8 to 12 weeks and has a 95 percent success rate.
    • “But almost 15,000 Americans still die from hepatitis C annually. * * *
    • “Francis Collins, the former longtime NIH director who leads the White House National Hepatitis C Elimination Program, said the data “highlights an urgency for a bold response to hepatitis C.”

From the health plan design front

  • Fierce Healthcare discusses
    • “Following the COVID-19 pandemic, the rising tide of mental health concerns—particularly among children and adolescents—has been a major focus in the industry.
    • “But it’s not a new problem. Behavioral health needs have been on the rise for some time, and that’s why in 2018 the team at Elevance Health’s Carelon established the Suicide Prevention Program, which deploys data and predictive models to identify people at risk sooner and avoid potential self-harm or suicide events. 
    • “Suicide is the second-leading cause of death for young people, and rates have increased by 56% in the last 20 years. Through the prevention program, Carelon saw a reduction of more than 20% in suicidal events among adolescents and young adults with commercial coverage.
    • I”n addition, this corresponded to a 30% decrease in per member per month behavioral health spending.”
  • The Society for Human Resource Management identifies four ways to boost employee satisfaction with high deductible plans connected with health savings accounts.

From the generative AI front,

  • Beckers Hospital Review notes,
    • “Johnson City, Tenn.-based Ballad Health is using artificial intelligence to identify potential medication errors and improve pharmacy workflows, the health system said June 29. 
    • “Ballad is using a medication safety monitoring platform from MedAware for this effort. The platform monitors drug prescriptions in real-time and compares this information against patient data from the health system’s EHR to flag potentially dangerous or fatal drug interactions. 
    • “The Ballad Health Innovation Center and Ballad Ventures, the system’s venture capital subsidiary, is funding the project with MedAware.

From the healthcare spending front —

  • Healthcare Dive relates
    • “Healthcare costs are expected to rise 7% next year as inflation drives providers to seek rate increases from insurers and pharmaceutical costs rise, according to PwC’s annual report.
    • “The consultancy, which surveyed actuaries at insurers that offer group and individual plans, said the increase outstrips its predictions for 2022 and 2023, which were 5.5% and 6% respectively.
    • “Some trends are pushing costs down, like the availability of more biosimilar drugs and a shift toward cheaper outpatient care. A number of other factors are expected to be cost neutral but key to watch, including health plans’ investment in value-based care, COVID-19 impacts, behavioral healthcare utilization, health equity initiatives, price transparency rules and Medicaid redeterminations, PwC said.
  • and
    • “Primary care physicians saw their compensation rise faster than other medical and surgical specialties in 2022, as significant E/M coding changes enacted by the CMS kicked into gear and volume stabilized coming out of the pandemic.
    • “Medical groups and healthcare organizations reported a 6.1% increase in primary care compensation in 2022 compared to 2021 in the AMGA’s most recent compensation survey published on Wednesday. That’s compared to 1.5% and 1.6% increases for medical and surgical specialties, respectively.
    • “Medical groups’ revenue increased faster than compensation gains for physicians, a trend the AMGA said could be due to groups using more revenue to address higher expenses as supply and labor costs soared.”
  • Health Payer Intelligence points out
    • “Individuals with depression, anxiety, or both who are enrolled in large employer-sponsored health plans have higher out-of-pocket spending than individuals without such diagnoses, according to an issue brief from the Peterson-KFF Health System Tracker.
    • “These findings of higher health spending among privately insured individuals receiving treatment for depression and/or anxiety come at a time of rising health costs. Health insurance is already expensive for enrollees with private insurance, and treatment for mental health conditions can further escalate these costs,” the brief noted.
    • “The researchers used large employer health plan claims from the 2021 MerativeMarketScan Commercial Database. Nine percent of adult, large employer-sponsored health plan enrollees had a depression or anxiety diagnosis or both.
    • “Members with a generalized anxiety disorder (anxiety) diagnosis, a depression diagnosis, or both spent, on average, $1,501 per year in out-of-pocket costs. This was nearly double the $863 in average annual out-of-pocket healthcare spending that individuals without one of these diagnoses spent.
    • “Moreover, total annual spending, including out-of-pocket healthcare costs, was 1.9 times higher for individuals with one of these diagnoses than those without one. Utilization was also twice as high for those diagnosed, who typically visited a provider’s office 7.4 times per year, while those without a diagnosis visited 3.2 times per year on average.

From the Food and Drug Administration (FDA) front —

  • The Wall Street Journal reports
    • “The promise of gene therapy has arrived for thousands of Americans with the most common and severe form of hemophilia.
    • “The U.S. Food and Drug Administration approved the first gene therapy for hemophilia A on Thursday, giving patients a long-awaited option for avoiding the burden of regular infusions and injections.
    • “That’s a complete game-changer for quality of life,” said Mike Reutershan, a 38-year-old medicinal chemist with hemophilia who lives in suburban Boston. “You don’t have to carry a bag of medicine around with you.” 
    • “The FDA approved the new gene therapy, called Roctavian and made by BioMarin Pharmaceutical, for adults with a severe form of the disease. Roctavian is infused just once.  
    • “Priced at $2.9 million, the drug now ranks among the most expensive in the world. But the price is in line with the cost of other new gene therapies, a groundbreaking type of treatment that replaces a missing or faulty gene.”
  • Cardiovascular Business informs us
    • “Just eight days after approving the first anti-inflammatory drug for cardiovascular disease, the U.S. Food and Drug Administration (FDA) has made another historic approval focused on cardiovascular health. 
    • “The agency announced Wednesday, June 29, that it has approved donislecel, a new pancreatic islet cellular therapy made from the pancreatic cells of deceased donors, for the treatment of type 1 diabetes among adult patients with severe hypoglycemia. Donislecel is marketed and sold by Chicago-based CellTrans under the brand name Lantidra. 
    • “This represents the first time the FDA has approved a cellular therapy for type 1 diabetes.”
  • Biopharma Dive calls attention to ten clinical trials to watch in the second half of this year.  

 

Tuesday Tidbits

David Ermer–CDC, Medical / Rx research, Mental health care, NIH, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The U.S. Supreme Court released three more opinions this morning. The Wall Street Journal reports
    • “The Supreme Court rejected a bid by Norfolk Southern to limit its state-court liability in states where it does relatively little business, ruling Tuesday that states can require companies to submit to their courts’ jurisdiction as a condition of doing business within their borders.
    • “While the case involved a long-pending workplace lawsuit filed by a retired railway employee from Virginia, Justice Neil Gorsuch, writing for a 5-4 majority of the justices, linked the issue to a Norfolk Southern train’s Feb. 3 derailment in East Palestine, Ohio.”
  • The Supreme Court has pending seven more decisions from its October 2022 term. The next decision day will be Thursday morning.
  • Beckers Hospital Review tells us,
    • “The Federal Trade Commission has proposed changes to the premerger notification form in addition to premerger notification rules implementing the Hart-Scott-Rodino Act, which requires organizations to report large transactions to the FTC and Justice Department for antitrust review.
    • “The HSR Act and its implementing rules related to mergers and acquisitions involve completing HSR Forms and waiting a specified period of time before completing the transaction.
    • “The proposed HSR changes would help the agencies to more effectively screen transactions for potential competition issues within the waiting period, which is generally 30 days. The FTC said that this competition review is important to identify deals that require in-depth investigations to determine whether they would violate antitrust laws and, if so, to seek to block the proposed transaction.”
  • HHS Inspector General announced posting
    • “its final rule implementing information blocking penalties. The final rule establishes the statutory penalties created by the 21st Century Cures Act. If OIG determines that an individual or entity has committed information blocking, they may be subject up to a $1 million penalty per violation.
    • “The final rule does not impose new information blocking requirements. OIG incorporated regulations published by the Office of the National Coordinator for Health Information Technology (ONC) as the basis for enforcing information blocking penalties. For more information on ONC’s information blocking regulations see: Information Blocking.
    • “To report complaints about information blocking, please visit the ONC Information Blocking Portal or the OIG Hotline.”
  • HR Dive points out the steps that covered employers to take to comply with the Pregnant Workers Fairness Act, which took effect today.

From the public health front —

  • The Washington Post reports,
    • “For the first time in two decades, malaria infections have been confirmed in people who did not travel outside the United States, leading federal health authorities to warn about the potential for transmission of the mosquito-born disease within the nation’s borders.
    • “Four people in Sarasota County, Fla., and one in Cameron County, Tex., were confirmed as having been infected between late May and late June through local transmission. All have gotten treatment and are recovering as health officials watch for additional cases, the Centers for Disease Control and Prevention said.
    • “Although the potentially fatal disease was once endemic, it was declared eliminated in the United States in 1951. About 2,000 people are diagnosed with malaria in the nation each year, but those cases have involved trips abroad. For a handful who came down with the disease in recent months, that was not the case.
    • “The risk of getting malaria in the United States “remains extremely low,” the CDC said. Still, experts said Americans should be aware of the possibility and take steps to prevent mosquito bites.”
  • The CDC discusses a recent study examining the health impact of widening the age range eligible for cost-free in-network diabetes type 2 testing.
  • The Health and Human Services Department “released a report showcasing evidence-based interventions to support physical activity among adults ages 65 years and older. By the year 2030, 1 in every 5 Americans will be age 65 or over. More than 85 percent of older adults currently have at least 1 chronic health condition. The growing population of older adults can gain substantial health benefits and prevent or manage chronic disease by engaging in physical activity.”

From the Rx coverage front —

  • Health Affairs lets us know that
    • “Using Medicare claims, we documented US prescribing patterns for originator biologic trastuzumab (Herceptin), a targeted cancer therapy, and five biosimilar entrants since 2019. The first biosimilar captured a dominant share, but over time, average sales prices of all products declined, and later entrants became dominant in some states. Despite strong brand loyalty to the first biosimilar, competitive pressure increased with subsequent entrants.”
  • Beckers Hospital Review relates
    • “With about a dozen cancer drugs on back order and no clear end to the shortages, the American Society of Clinical Oncology and the Society of Gynecologic Oncology recently advised clinicians to ration chemotherapy supplies. 
    • “The updated guidelines recommend curbing or halting pharmaceutical treatment for patients with “recurrent, agent-resistant cancers” — which means saving therapies for patients with a better chance of surviving. 
    • “The national cancer care group also recommended extending the time between treatments when appropriate; lessening waste by “optimizing vial size, dose rounding and using multi-use vials”; and providing support services to patients and clinicians experiencing “shortage-related distress.”
    • “Two cancer drugs in shortage that treat multiple cancers and cost about $20 per vial, cisplatin and carboplatin, have been in shortage for months. One of the main suppliers for the drugs ended operations in late 2022 after FDA investigators found numerous quality infractions and ruined reporting documents. In another inspection, the agency found more quality issues, which could further delay expected recovery. 
    • “The FDA allowed a China-based drug company to produce and import cisplatin, and the agency is working to boost carboplatin supplies.”

From the studies front —

  • The National Institutes of Health announced
    • “In people with Alzheimer’s disease, the underlying changes in the brain associated with dementia typically begin many years—or even decades—before a diagnosis. While pinpointing the exact causes of Alzheimer’s remains a major research challenge, they likely involve a combination of genetic, environmental, and lifestyle factors. Now an NIH-funded study elucidates the role of another likely culprit that you may not have considered: the human gut microbiome, the trillions of diverse bacteria and other microbes that live primarily in our intestines.
    • “Earlier studies had showed that the gut microbiomes of people with symptomatic Alzheimer’s disease differ from those of healthy people with normal cognition [2]. What this new work advances is that these differences arise early on in people who will develop Alzheimer’s, even before any obvious symptoms appear.
    • “The science still has a ways to go before we’ll know if specific dietary changes can alter the gut microbiome and modify its influence on the brain in the right ways. But what’s exciting about this finding is it raises the possibility that doctors one day could test a patient’s stool sample to determine if what’s present from their gut microbiome correlates with greater early risk for Alzheimer’s dementia. Such a test would help doctors detect Alzheimer’s earlier and intervene sooner to slow or ideally even halt its advance.”
  • Fierce Healthcare informs us
    • “Medicare Advantage (MA) beneficiaries given home-delivered meals in the four weeks after being discharged from a hospital were not only less likely to be readmitted within 30 days, they were also less likely to die, according to a study in JAMA Health Forum.
    • “The 2018 Chronic Care Act gave MA plans greater leverage to address the social determinants of healthcare. In addition to giving insurers an impetus for launching dietary programs, the act also covers transportation for beneficiaries and other at-home services.
    • “The study states that “nearly three-quarters of MA plans offered meals as a supplemental benefit in 2022, mostly driven by expectations of downstream cost savings based on findings from earlier observational studies of community-based nutrition programs, and desires to maintain market parity in an increasingly competitive MA space.
    • “Beginning in January 2021, Kaiser Permanente Southern California (KPSC) began offering home-delivered meals to eligible MA enrollees. The comparative cohort study in JAMA Health Forum examines data from 4,032 KPSC MA enrollees who’d been hospitalized for heart failure and 7,944 who’d been hospitalized for other reasons after they’d been discharged from Jan. 1, 2021, to Jan. 31, 2022. The data come from 15 hospitals in the KPSC network.”

In U.S. healthcare business news —

  • Healthcare Dive reports
    • “Walgreens missed Wall Street earnings expectations in its third fiscal quarter and cut its 2023 outlook, citing macro factors including a weak respiratory season and falling demand for COVID-19 tests and vaccines.
    • “The pharmacy chain did beat the Street’s revenue expectations with a topline of $35.4 billion, up 9% year over year, thanks in part to its expanding U.S. Healthcare segment, which includes value-based medical group VillageMD.”

Monday Roundup

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–

From Washington DC —

Photo by Sven Read on Unsplash
  • Federal News Network reports,
    • “The House and Senate armed services committees each finished their work on their versions of next year’s defense authorization bill within a day of one another, with both key committees approving overall funding levels that closely match the Biden administration’s 2024 funding request of $842 billion in discretionary DoD spending.
    • “The Senate Armed Service Committee’s bill, approved behind closed doors on Friday, would authorize $844 billion next year, while the House version, debated in a public session a day earlier, would match the administration’s request.
    • “Another area of commonality: both committees endorsed the administration’s proposed pay increase for military service members, making it highly likely that they’ll receive a 2024 increase of 5.2%, the largest military pay raise since 2002.
    • “For now, the measures do not include language that would grant the administration’s request for the same pay raise for federal civilian workers. A provision to achieve that could still be added when the bills reach the House and Senate floors; however, a large faction of House Republicans is pushing an alternative plan that would make all civil servants’ pay increases “merit-based.”
  • The Centers for Medicare and Medicaid Services issued,
    • “a proposed rule that proposes to update payment rates and policies and includes requests for information under the end-stage renal disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2024. This rule also proposes an update to the Acute Kidney Injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2024. In addition, the rule proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2024, CMS is proposing to increase the ESRD PPS base rate to $269.99, increasing total payments to ESRD facilities by approximately 1.6 percent. The CY 2024 ESRD PPS proposed rule also includes several proposals and requests for information related to ESRD PPS payment policies.
  • The National Institutes of Health announced,
    • “The Biden-Harris Administration awarded $50 million to launch the Persistent Poverty Initiative, an initiative to alleviate the cumulative effects of persistent poverty on cancer outcomes by building research capacity, fostering cancer prevention research, and promoting the implementation of community-based programs. The Persistent Poverty Initiative is the first major program to address the structural and institutional factors of persistent poverty in the context of cancer. It is coordinated by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). These awards create five new Centers for Cancer Control Research in Persistent Poverty Areas that will advance key priorities of the Administration’s Cancer Moonshot — to reduce inequities in the structural drivers of cancer and prevent more cancers before they start by reducing tobacco use and making sure everyone has access to healthy food.”
  • FedScoop informs us,
    • “Most federal government employees will receive between four and eight additional hours of leave time in 2023, the U.S. Office of Personnel Management said.
    • “The 2023 leave year ending Jan. 13, 2024, will have 27 pay periods, OPM said in a memo sent on Monday to human resource directors of U.S. government agencies. That means most federal employees will receive an additional pay period’s worth of leave in 2023, which could be four, six, or eight hours depending on their accrual rate, according to the memo.
    • “The change doesn’t apply to agencies whose first pay period was Jan. 8, 2023, as they will have 26 pay periods, the memo said. 
    • “While most federal workers will get more leave time, the maximum carryover amount for annual leave – 240 hours for most employees and 360 hours for overseas employees – won’t change, OPM said. It encouraged agencies to remind affected workers to use any time over that limit before the end of the leave year so they don’t lose it.”

From the public health front —

  • CBS News tells us,
    • The Centers for Disease Control and Prevention is now separately tracking several new COVID-19 variants, the agency announced Friday, adding more Omicron descendants to an increasingly complex list of new strains that are competing nationwide. 
    • Among the new variants now being tracked by the CDC is EU.1.1, a strain first designated by scientists earlier this year over its rapid ascent in some European countries. 
    • The variant is a more distant descendant of the XBB.1.5 variant that had surged earlier this year, with a handful of more mutations to its spike protein that may be driving its spread. 
    • The CDC estimates that EU.1.1 is now 1.7% of U.S. cases nationwide but may have already reached as much as 8.7% of cases in the region spanning Colorado, Montana, North Dakota, South Dakota, Utah and Wyoming.
    • It is too early to know whether EU.1.1 will lead to new or different symptoms in the U.S.
  • FEHBlog note — Reassuringly, the variants remain descendants of the late, great Omicron.
  • Helio informs us,
    • “Prenatal lifestyle interventions delivered by an allied health professional, with individual delivery formats and a moderate number of sessions, decreased gestational weight gain., according to data published in JAMA Network Open.
    • “In addition, researchers observed associations with reduced gestational weight gain among physical activity and mixed behavioral interventions. 
    • “These findings suggest that future pragmatic research should focus on testing and evaluating components to inform implementation in varied antenatal care settings, including those with limited resources, to optimize population benefits for pregnant individuals and the next generation,” the researchers wrote.”

From the obesity drug front —

  • STAT News reports,
    • “Almost half of Americans would be willing to spend up to $100 a month for new weight loss medicines such as Wegovy, and one-third say they would indefinitely pay whatever they can afford to get the drugs, according to a new survey by STAT and The Harris Poll.
    • “Although 47% say they would only spend the money up to a point — such as losing a certain amount of weight, or up until a special event — demand is so great that nearly one-quarter said they would pay up to $250 each month. And another 17% percent are willing to shell out as much as $500 each month. The survey, which polled 2,046 U.S. adults, was conducted earlier this month.”
  • and
    • An experimental pill from Eli Lilly led to 14.7% weight loss on the highest dose in a 36-week trial, heating up the growing competition among drugmakers to develop an effective oral obesity therapy.
    • The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year. The full results, published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the American Diabetes Association conference.
    • Nonetheless, an overwhelming majority — 84% — believe insurance companies should cover the injectable medicines, which carry list prices ranging from $900 to $1,300 a month.
  • Meanwhile, Healthcare Dive relates,
    • “Pfizer is scrapping of one of two experimental weight-loss pills it’s been developing after spotting signs of potential safety concerns in clinical testing.  
    • “The company on Monday said the decision to stop testing of the pill, lotiglipron, was made after receiving the results from drug-drug interaction studies and observing liver enzyme elevations in early- and mid-stage tests. Patients with liver enzyme spikes, which can be signs of organ damage, didn’t have side effects or require treatment, Pfizer said.  
    • “Pfizer will now focus on its other, similar weight-loss prospect, danuglipron, which so far hasn’t had such concerns. Danuglipron is currently in Phase 2 testing in Type 2 diabetes and obesity, and could move into late-stage development by the end of the year.”  

In other Rx and medical device news

  • Biopharma Dive identifies five Food and Drug Administration (FDA) decisions to watch for in this third quarter of 2023.
  • Beckers Hospital Review points out
    • The FDA has given a fast-track designation to a drug designed to prevent infection from both influenza A and B strains created by San Diego-based Cidara Therapeutics, according to a June 22 news release.
    • The novel drug, CD388, is being developed alongside Janssen Pharmaceuticals primarily for flu prevention in adults who are high risk as well as for individuals for whom flu vaccines “are either ineffective or contraindicated,” the release states. 
    • The FDA’s decision could prove to be timely as early data from the flu season that is currently underway in the Southern Hemisphere is showing that both influenza A and B are both circulating.
  • MedTech Dive notes
    • “Dexcom next year will introduce a continuous glucose monitor aimed at the 25 million non-insulin-using Americans with Type 2 diabetes.
    • “The CGM, which is based on the Dexcom G7, will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.
    • “Dexcom’s analysis shows those patients want help understanding the effect of lifestyle on blood glucose and staying off insulin, leading the company to develop a revised set of features for the new device.” 

From the U.S. healthcare business front

  • The Wall Street Journal reports
    • “UnitedHealth Group will acquire Amedisys for $101 a share, or nearly $3.29 billion, upending a prior deal for the home-health provider to combine with Option Care Health
    • “Amedisys said Monday that it has agreed to a takeover by UnitedHealth’s Optum health-services arm in which each Amedisys share will be converted into the right to $101 in cash. 
    • “Amedisys will become a wholly owned subsidiary of UnitedHealth when the transaction is completed. UnitedHealth’s UnitedHealthcare is the biggest U.S. health insurer. Its Optum business includes a sprawling network of physician groups, surgery centers and other assets.” * * *
    • “The companies didn’t provide an expected closing date on the acquisition, which still needs to be approved by regulators and Amedisys shareholders. 
    • “The combination is likely to draw close antitrust scrutiny from the Federal Trade Commission. Optum will be seeking to take over the No. 2 competitor in the home-health business after recently absorbing the No. 3 company, according to analysts. * * *
    • “When it announced its offer for Amedisys, UnitedHealth said it was confident it could secure approval for the combination, partly because of how fragmented the home-health business is.”
  • Health Payer Intelligence points out
    • “What will happen to the volume and value of mergers and acquisitions in 2023? This is a question at the forefront of payers’ minds as the healthcare industry emerges from the uncertainties of the coronavirus pandemic.
    • “The twelve months ending on May 15, 2023, witnessed strong merger and acquisition volume despite various challenges, according to a report from PwC. At the end of the report’s timeframe, the volume of deals was nearly twice as high as the period of 2018 to 2020.
    • “Still, health services deals dipped slightly, dropping by four percent from 2022. Volume dropped from 1,738 in 2022 to 1,661 as of May 15, 2023.
    • “Deal values declined significantly by 15 percent. In 2022, deal value amounted to $100 billion. In the study’s timeframe, deal value totaled $85 billion. Megadeal values, specifically, have been more than halved in the last two years since 2021, a trend which might continue due to rate hikes.”