Friday Factoids

Medical / Rx research

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the No Surprises Act front,

  • The American Hospital Association informs us,
    • “The U.S. District Court for the Eastern District of Texas, for a third time, ruled to set aside certain regulations implementing the No Surprises Act. In this case, the Texas Medical Association, joined by several air ambulance providers and supported by an amicus filed by the AHA, successfully argued that the methodology for how insurers calculate the qualifying payment amount tilts the arbitration process in insurers’ favor.” 
  • The Centers for Medicare and Medicaid Services adds,
    • “On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services, Case No. 6:22-cv-450-JDK (TMA III), vacating certain portions of 86 Fed. Reg. 36,872, 45 C.F.R. § 149.130 and 149.140 , 26 C.F.R. § 54.9816-6T and 54.9817-1T, 29 C.F.R. § 2590.716-6 and 2590.717-1, and 5 C.F.R. § 890.114(a) as well as certain portions of several guidance documents. As a result of the TMA III decision, effective immediately, the Departments have temporarily suspended all Federal IDR process operations until the Departments can provide additional instructions. Disputing parties should continue to engage in open negotiation.”
  • The FEHBlog hopes that the federal regulators move to stay this decision pending appeal to the U.S. Court of Appeals for the Fifth Circuit. That court is already reviewing Judge Kernodle’s first decision modifying the final No Surprises Act implementing rule (No. 23-40217).

From Washington, DC —

  • STAT News tells us,
    • “With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different.
    • “In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention [CDC] and the Food and Drug Administration [FDA] detailed the various countermeasures available to combat COVID-19, RSV, and influenza, and discussed the expected timing on the rollouts of these tools. They spoke on condition that their names and titles would not be disclosed.
    • “We are in our strongest position yet to be able to fight COVID-19 as well as the other viruses that are responsible for the majority of fall and winter hospitalizations,” one CDC official said. “We also have more tools, including … for the first time ever, vaccines for all three of the major fall and winter respiratory viruses — influenza, Covid, and RSV. Our goal, our imperative, our task is to make sure we’re using those tools.”
    • “The updated Covid vaccines have not yet been cleared by the FDA, but that must be coming in the next two and a half weeks or so, because a meeting of the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, has been slated for Sept. 12. ACIP must vote on whether to recommend the updated vaccines — and the recommendation must be endorsed by CDC Director Mandy Cohen — before they can begin to be used. The federal officials said the vaccine rollout would begin by mid-September.”
  • The CDC also updated flu vaccine information for the 2023-24 flu season.
  • Per the U.S. Department of Justice,
    • “[On Wednesday, August 23, 2023,] Deputy Attorney General Lisa O. Monaco delivered opening remarks at a roundtable meeting of senior Justice Department officials and investigative partners to announce the results of a coordinated, nationwide enforcement action to combat COVID-19 fraud, which included 718 enforcement actions – including federal criminal charges against 371 defendants – for offenses related to over $836 million in alleged COVID-19 fraud. Deputy Attorney General Monaco also announced the launch of two additional COVID-19 Fraud Enforcement Strike Forces: one at the U.S. Attorney’s Office for the District of Colorado and one at the U.S. Attorney’s Office for the District of New Jersey. These two strike forces add to the three strike forces launched in September 2022 in the Eastern and Central Districts of California, the Southern District of Florida, and the District of Maryland.”

From the medical and Rx research fronts —

  • BioPharma Dive reports,
    • “Two weeks ago, Danish drugmaker Novo Nordisk released results of a large trial showing its weight loss drug Wegovy can help prevent heart attacks and strokes in overweight people with cardiovascular disease. It followed up on those landmark data Friday with further evidence the injectable drug helps protect the heart.
    • “In people with a form of heart failure, Wegovy reduced disease symptoms and improved quality of life and exercise duration by more than placebo, according to results from the trial, codenamed “STEP-HFpEF.” The data were released at the European Society of Cardiology meeting and published in The New England Journal of Medicine.
    • “The newly released data could further help Novo persuade insurers to provide broader coverage for Wegovy, which carries a list price of more than $17,000 a year. Insurers might be more open to offering coverage if they know the shot can avert expensive hospitalizations and episodes of care.
    • “Broad coverage also could help Novo retain its lead over rival Eli Lilly, which has a similarly acting drug Mounjaro that is approved to treat diabetes but not yet weight loss.”
  • MedPage Today points out,
    • A novel 14-year risk score helped identify people from age 50 onward at risk for all-cause dementia, a large U.K. study showed.
    • The tool, called the U.K. Biobank Dementia Risk Score (UKBDRS), was developed and validated in two U.K. cohorts, reported Raihaan Patel, Ph.D., of the University of Oxford in England, and co-authors.

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • Employers will pay more than $15,000 on average for each employee’s healthcare in 2024, according to an analysis from consulting firm Aon. 
    • Employer-sponsored insurance costs will rise 8.5 percent in 2024, up from an average of $13,906 per employee in 2023, according to Aon’s estimates published August 22.
    • Read the full report here.
  • Fortunately, OPM’s decision to allow FEHB carriers to offer Medicare Part D EGWP arrangements in 2024 will offset the factors discussed in the Aon report.
  • Beckers Hospital Review reports,
    • “Ongoing increases in expenses were part of the drive behind lower hospital operating margins in July, according to a Syntellis report.
    • “While such margins remained positive, they contracted for the first time since rising into the black in March, the report showed. The operating margin median for July was 1.1 percent compared to 2 percent in June, but still higher than the March through May period and 2.6 percentage points higher than July 2022.
    • “While overall expenses were up 3.6 percent on the same period in 2022, labor expenses increased 2.1 percent. Supplies and drug costs were both up over 5 percent, the report said.”
  • Per Healthcare Dive,
    • “A new brief from out Wednesday from research firm KFF explores the potential of consumer cost changes and antitrust regulation when healthcare systems engage in cross-market mergers, including a body of research indicating possible healthcare price increases.
    • “Antitrust agencies have historically focused on mergers between hospitals and health systems that operate in the same geographic market, the KFF brief noted. The Federal Trade Commission has never formally challenged a cross-market merger and antitrust agencies have not developed guidelines for evaluating them.
    • “Regulating cross-market mergers, will be “on the radar” of policymakers and regulators as they become increasingly common, KFF said. Between 2010 and 2019, cross-market mergers made up 55% of hospital M&A ventures, and drove at least nine large-scale mergers since June 2021.”

Midweek update

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC –

  • STAT News informs us,
    • “The Centers for Disease Control and Prevention said Wednesday it’s too early to tell whether a new version of the SARS-CoV-2 virus that has triggered some international concern will actually prove to be disruptive.
    • “In a preliminary statement about the BA.2.86 subvariant, the CDC also revealed that updated Covid-19 vaccines should be available across the country as early as mid-September, earlier than previous estimates have placed the start of the fall booster campaign.
    • “The vaccines, made by Pfizer, Moderna, and Novavax, must first be authorized by the Food and Drug Administration and recommended by the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, and the CDC itself. The three manufacturers have said they have doses at the ready for when the FDA and CDC sign-offs come.”
  • The National Institutes of Health announced,
    • “An international research team has generated the first truly complete sequence of a human Y chromosome, the final human chromosome to be fully sequenced. The new sequence, which fills in gaps across more than 50% of the Y chromosome’s length, uncovers important genomic features with implications for fertility, such as factors in sperm production. The study, led by the Telomere-to-Telomere (T2T) Consortium, a team of researchers funded by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, was published today in Nature.”
  • Levita Magnetics, “whose mission is to help more patients get access to better surgery,” tells us,
    • “U.S. Food and Drug Administration (FDA) gave Levita clearance for its MARS™ platform.
    • “The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. Harnessing the power of both magnets and machines, MARS reduces the number of incisions and enables surgeons to have complete control during laparoscopic procedures, all in a compact footprint designed to fit into existing operating rooms.
    • “Building on the success of its first commercial product, the Levita Magnetic Surgical System®, Levita designed MARS to deliver the same patient benefits as Magnetic Surgery®, while empowering surgeons with increased control of surgical instruments and providing an efficient way for hospitals and ambulatory surgery centers (ASCs) to incorporate this new technology.”

From the public health front,

  • Ovia Health released a white paper “externally validating Ovia’s preterm birth reduction programming.
  • STAT News discusses steps being taken to cure a “severe shortage of doctors who actually specialize in treating obesity” in the United States.
    • “To ensure that all 115 million Americans with obesity have access to care, the field should focus on empowering primary care providers to treat “simple obesity,” or uncomplicated cases, said Kimberly Gudzune, medical director of the American Board of Obesity Medicine. “That, hopefully, prevents the development of some of the complications.”
    • “And this work begins in medical school and residency. For instance, [Juliana] Simonetti [,an obesity doctor at the University of Utah,] has proposed a one-month elective course on obesity at the University of Utah School of Medicine, and Freshwater has been working with the Obesity Medicine Association to incorporate education into training programs nationwide, including the local family medicine residency in Boise.”

From the Rx coverage front,

  • BioPharma Dive points out,
    • “A closely watched, experimental Roche medicine may be helping lung cancer patients live longer, spurring renewed optimism about an emerging class of immunotherapy treatments.
    • “The data come from an interim analysis of a Phase 3 trial pairing the drug, tiragolumab, with a marketed Roche immunotherapy called Tecentriq in patients with non-small cell lung cancer. Roche completed the analysis in February, but never publicly disclosed its findings, which were inadvertently released on its website Tuesday night and discovered by Wall Street analysts. The company is expected to provide the final study results either late this year or early next.”
  • Per Fierce Healthcare,
    • “CVS Health has launched a new segment that aims to work with drugmakers to bring additional biosimilars to market.
    • “The new, wholly owned subsidiary, called Cordavis, aims to develop a biosimilar portfolio with the goal of expanding access to these drugs across the country. Increased uptake of biosimilars can drive down costs of pricey brand drugs that otherwise lack market competition, CVS said.”

From the U.S. healthcare business front,

  • Forbes delves into Amazon’s recently expanded Amazon Clinic product.
    • “With Amazon Clinic, one of the world’s biggest technology companies is looking to infuse the black box of healthcare pricing with some actual transparency. Login to the site and you’ll see that a person who tests positive for Covid-19 in Wyoming can pay $35 for a message-based conversation with a doctor, who will respond within an hour and 45 minutes. Or $40 to get a response in 30 minutes. A video visit costs $74 with a wait time of around an hour and 30 minutes.
    • “Amazon isn’t directly providing the medical services. Instead, the tech giant has contracted with four different startups to provide message and video appointments for around 30 medical conditions. The result is a dynamic marketplace where customers can see pricing, wait times and the typical number of prescription refills upfront. “If you want the lower cost provider, you can choose that. If you are actually prioritizing the speed at which someone is getting back to you, you can prioritize that as well,” Nworah Ayogu, chief medical officer and general manager of Amazon Clinic tells Forbes. “We think really being able to surface different options for different customers lets them choose what’s important to them.”
  • Per Fierce Healthcare,
    • “Most Americans support the idea of value-based care but don’t understand or resonate with the term, according to new research from United States of Care. 
    • “USofCare is a self-described nonpartisan think tank focused on building a more equitable healthcare system. Its latest research relied on (PDF) virtual focus groups with a dozen participants, a national survey that reached 1,000 respondents and a “ReMesh” session, or an AI-driven feedback collection platform that engaged 100 participants more deeply.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Federal Times says,
    • “Members of Congress are urging the Office of Personnel Management to ensure providers of its health insurance program do not exclude same-sex couples and single individuals from seeking the same artificial reproductive procedures that other federal employees do.”
  • The FEHBlog believes that this expresssed concern misunderstands OPM’s 2024 call letter and technical guidance which focus on fertility coverage and requires carriers to cover artificial insemination, which is typically used by same-sex couples and single individuals.
  • KFF tells us,
  • “A new proposal from the Centers for Medicare & Medicaid Services * * * would authorize Medicare payments to health care professionals to train informal caregivers who manage medications, assist loved ones with activities such as toileting and dressing, and oversee the use of medical equipment. * * *
  • “Several details of CMS’ proposal have yet to be finalized. Notably, CMS has asked for public comments on who should be considered a family caregiver for the purposes of training and how often training should be delivered.
  • “If you’d like to let CMS know what you think about its caregiving training proposal, you can comment on the CMS siteuntil 5 p.m. ET on Sept. 11. The expectation is that Medicare will start paying for caregiver training next year, and caregivers should start asking for it then.”

From the public health front,

  • The Centers for Disease Control announced the availability of flu shots for the 2022-23 flu season and offers flu shot finder tool.
  • Beckers Hospital Review informs us
    • “Health officials have started monitoring BA.2.86 — a highly mutated version of the COVID-19 virus. Not much is known yet about the newly detected lineage, though its large number of mutations has prompted the World Health Organization and CDC to begin tracking the strain. 
    • “The World Health Organization added BA.2.86, dubbed “Pirola” on social media by scientists closely tracking evolutionary changes in the virus, to its list of variants under monitoring Aug. 17. Shortly after, the CDC also said it has started tracking the lineage. 
    • “CDC is gathering more information and will share more about this lineage as we learn it,” the agency said on the social media platform X, formerly known as Twitter. So far, BA.2.86 has been detected in Israel, Denmark, the U.S. and the U.K. So far, only six cases of the new strain have been identified, with the single U.S. case detected in Michigan.” 
  • STAT News discusses the low rates of lung cancer screening in the U.S. notwithstanding the fact that lung cancer is the deadliest cancer in our country.
  • The National Institutes of Health informs us
    • “Past-year use of marijuana and hallucinogens by adults 35 to 50 years old continued a long-term upward trajectory to reach all-time highs in 2022, according to the Monitoring the Future (MTF) panel study, an annual survey of substance use behaviors and attitudes of adults 19 to 60 years old. Among younger adults aged 19 to 30, reports of past-year marijuana and hallucinogen use as well as marijuana and nicotine vaping significantly increased in the past five years, with marijuana use and vaping at their highest historic levels for this age group in 2022. The MTF study is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and is conducted by scientists at the University of Michigan’s Institute for Social Research, Ann Arbor.
    • “While binge drinking has generally declined for the past 10 years among younger adults, adults aged 35 to 50 in 2022 reported the highest prevalence of binge drinking ever recorded for this age group, which also represents a significant past-year, five-year, and 10-year increase.
    • “Substance use is not limited to teens and young adults, and these data help us understand how people use drugs across the lifespan,” said NIDA director, Nora Volkow, M.D. “Understanding these trends is a first step, and it is crucial that research continues to illuminate how substance use and related health impacts may change over time. We want to ensure that people from the earliest to the latest stages in adulthood are equipped with up-to-date knowledge to help inform decisions related to substance use.”

From the medical research front,

  • STAT News relates that “An innovative eye stem cell transplant could help restore vision in people with chemical injuries”
  • Medscape dives into the issue of whether artificial kidneys can replace dialysis.

From the Rx coverage front,

  • The Institute for Clincical and Economic Research reminds us
    • “ICER’s 2022 obesity management Final Evidence Report included subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma). We found that semaglutide used for weight loss would achieve common thresholds for cost-effectiveness if priced between $7,500 – $9,800 per year. The current annual estimated net price is over $13,000.
    • “The Financial Times quoted ICER’s Chief Medical Officer, David Rind, MD:
      • “At current prices, ICER estimated that only 0.1 percent could be treated within five years without ‘major budget disruptions’ for the insurers. ‘The options are to move money away from other healthcare, raise premiums, or taxes if you’re the government, or manufacturers could lower the price to a cost-effective price and still make enormous amounts of money because enormous numbers of patients want this,’ Rind says.” 

From the U.S. healthcare business front

  • Forbes reports,
    • “Blue Shield of California said Thursday it will soon work with several companies to manage the prescriptions of its nearly 5 million health plan members, including Amazon Pharmacy, Cuban’s company and a fast-growing pharmacy benefit manager known as Abarca, which will “pay prescription drug claims.” Financial terms of the arrangement were not disclosed.
    • “But CVS Caremark will continue to provide specialty pharmacy services for Blue Shield “members with complex conditions, including education and high-touch patient support,” the health plan said.
    • “And it’s the specialty pharmacy business that may be a bigger deal to CVS and patients looking for a better deal on their costliest medicines.”
  • Per MedCity News,
    • “Fee-for-services payment models in the primary care ecosystem are doing a poor job of keeping Americans healthy and reducing the nation’s massive amount of healthcare spending, two CEOs of primary care companies said during a recent webinar. They argued that stakeholders in the primary care space need to come together to support more value-based care arrangements to reduce costs, advance population health and improve the patient experience.”
  • Per Healthcare Dive,
    • Rochester, Minnesota-based Mayo Clinic on Thursday reported increased operating revenue and income year over year in its second quarter earnings, driven by higher outpatient visits and surgical cases.
    • The nonprofit posted $4.5 billion in operating revenue, up 10.8% year over year, and $300 million in operating income. Operating expenses rose 7.5% compared to the prior-year period, totaling nearly $4.2 billion, though the cost of salaries and benefits increased at a slower rate this quarter compared with last year.
    • The earnings mark the second consecutive quarter of increased operating margins for Mayo, as the health system attempts to turn around after a rocky 2022 when its operating profit was cut in half.

Thursday Miscellany

David Ermer–Medical / Rx research, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network says,
    • “The largest payroll provider for federal employees is at risk, and if there aren’t improvements soon, hundreds of thousands of employees could see the impacts immediately.
    • “The National Finance Center, an agency housed in the Agriculture Department, is struggling with legacy IT systems, limited funding, low staffing — and even building maintenance issues. In a new nine-month study, the National Academy of Public Administration said NFC must take immediate action or else risk being unable to provide payroll services to more than 170 agency customers, spanning some 650,000 federal employees.
    • “It is unthinkable that the U.S. government could find itself in a position where it could not pay a sizeable portion of the federal workforce — but it could happen, at least in the short term,” the NAPA report, published earlier this month, said.”
  • Ruh-roh.
  • In other puzzling news, Healthcare Dive informs us that a committee advising Congress on how to avoid surprise billing with ground ambulance charges decided against using the No Surprises Act IDR process but does not appear to have a good alternative. The committee meets again in October and plans to submit its report to Congress later this year.

From the U.S. healthcare business front,

  • The Wall Street Journal lets us know,
    • “A major health insurer says it will jettison the complicated system that Americans use to pay for drugs and create something that aims to be better, with partners including Amazon.com and the entrepreneur Mark Cuban.
    • “Blue Shield of California said it is dropping CVS Health’s Caremark, the pharmacy-benefit manager it currently uses, which negotiates drug prices and wraps in other services such as a mail-order pharmacy.
    • “Instead, Blue Shield, a nonprofit health plan with about 4.8 million members, will work with a selection of companies that each perform a designated function. Amazon will offer at-home drug delivery. Cuban said Mark Cuban Cost Plus Drug Company will provide access to low-cost medications, including through retail pharmacies. Another company, Abarca, will process drug claims.
    • “Blue Shield said that working with its partners, it aims to negotiate prices with pharmaceutical makers in a way that is different from the typical approach—with a simple net price structure that is supposed to eliminate rebates and hidden fees. 
    • “Blue Shield executives said that with one company handling many aspects of how drugs are procured through the system, it is often hard to track the flow of payments accurately.”
  • Health Payer Intelligence also discusses this new unbundled PBM arrangement and related developments.
  • The Segal Co. points out,
    • “The average stop-loss coverage premium increase is 8.4 percent for the nearly 250 health plans in Segal’s national medical stop-loss database’s 2023 dataset.
    • “The average includes groups that increased specific stop-loss deductible levels and/or aggregating specific stop-loss deductibles resulting in an overall reduced rate action. The average premium increase for groups that maintained similar specific stop-loss benefit levels as the prior year is 13.4 percent.”
  • Fierce Healthcare notes
    • “Tech company HealthEdge polled more than 2,800 insured people to delve into their attitudes toward their health plan and where they think payers can improve the experience.
    • “The survey asked respondents what they think insurers should be doing to improve satisfaction. Five steps ranked highest:
      • “Offer members incentives and/or rewards for healthy behaviors.
      • “Ensure they can easily access their medical records.
      • “Connect them to providers who offer care based on their preferences and personal traits.
      • “Provide high-quality customer service.
      • “Deploy tools and information that members can use to avoid high-cost care.”
  • From the miscellany department,
  • MedPage Today tells us,
    • “Few people with early Alzheimer’s disease met eligibility criteria for the new anti-amyloid monoclonal antibody treatments lecanemab (Leqembi) and aducanumab (Aduhelm), cross-sectional data from the Mayo Clinic Study of Aging showed.
    • “Of 237 people with mild cognitive impairment or mild dementia and increased brain amyloid on PET, clinical trial inclusion and exclusion criteria narrowed the number who would qualify for a lecanemab trial to 19 or 8% of the cohort, reported Maria Vassilaki, MD, Ph.D., of the Mayo Clinic in Rochester, Minnesota, and co-authors. * * *
    • “Our study results show only a small percentage of people with early Alzheimer’s disease may be eligible to receive treatment, mostly due to chronic health conditions and brain scan abnormalities common in older adults,” Vassilaki said in a statement.”
  • Fierce Healthcare relates,
    • “Kaiser Permanente has launched a multichannel support center to better address the social needs of members and nonmembers.
    • “The Community Support Hub is a self-service online directory of community resources. It also includes a call center for referral assistance. The solution will enable Kaiser to have more touch points with patients and better address the overall health of its communities.
    • “Many people need more than high-quality medical care to stay healthy, which is why we’re continuing to support our members beyond clinical walls to seamlessly connect them to the community resources they need to live healthy, thriving lives,” Bechara Choucair, M.D., senior vice president and chief health officer, said in a press release.
    • “If you’re not a KP member, your friend is, your neighbor is,” Vice President of Social Health Anand Shah, M.D., told Fierce Healthcare. In effect, there is no distinction between a member and a community. “You can’t have one without the other.” 
  • BioPharma Dive reports,
    • A drug combination involving Gilead’s antibody medicine Trodelvy shrank or eliminated tumors in just over half of the lung cancer patients who received it in a closely watched Phase 2 trial, according to data released ahead of a medical meeting next month. The findings suggest Trodelvy, currently approved to treat breast and bladder cancers, may be active against lung tumors as well.
    • The study, EVOKE-02, is testing several regimens of Trodelvy and Merck & Co.’s immunotherapy Keytruda with or without chemotherapy in patients newly diagnosed with advanced non-small cell lung cancer. Full results were inadvertently published Wednesday, weeks before the data will be presented at the World Conference on Lung Cancer.

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.”

Midweek Update

David Ermer–ACA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC —

  • MedPage Today informs us
    • “In a letter to the American public, the heads of the Drug Enforcement Administration (DEA) and FDA acknowledged ongoing stimulant drug shortages [to treat ADHD] and recounted their initiatives to improve access — while calling for efforts to diminish potential overuse and misuse of these powerful medications.”
  • and
    • “Jeanne Marrazzo, MD, will be the next director of the National Institute of Allergy and Infectious Diseases (NIAID), NIH Acting Director Lawrence Tabak, DDS, PhD, announced on Wednesday.
    • “Dr. Marrazzo brings a wealth of leadership experience from leading international clinical trials and translational research, managing a complex organizational budget that includes research funding and mentoring trainees in all stages of professional development,” Tabak said in a press release. “I look forward to welcoming Dr. Marrazzo to the NIH leadership team.”
  • FedWeek explains why the federal long-term care insurance program is the “Zeppo Marx” of federal employee benefits programs and offers information about deferred annuities available to federal employees.
    • Conundrum “If you are eligible for a deferred annuity, you may elect a survivor annuity. However, you won’t be eligible either to participate in the Federal Employees Health Benefits program or acquire Federal Employees’ Life Insurance coverage.”

From the public health front —

  • From Healthcare Dive, we have an opinion piece titled, “Strengthening primary care the key to fixing healthcare system woes. Primary care advocates Ann Greiner and Shawn Martin argue the U.S. needs to turn around decades of underinvestment in its primary care chassis.” Check it out.
  • The Wall Street Journal reports that some large employer-sponsored health plans, such as the University of Texas, are canceling coverage of GLP-1 agonistes, like Wegovy, for weight loss treatment due to the high cost of the drugs. The UT plan will continue to cover these drugs, like Ozempic, for diabetes treatment.
    • “The prescription-drug benefit plan for state government employees in Connecticut now requires members to obtain anti-obesity drugs through Intellihealth, a Connecticut-based, anti-obesity medical practice that offers telehealth and app-based care.  
    • “The state’s costs for the GLP-1 anti-obesity drugs for plan members have risen 50% since 2020, and are on track for $30 million annually by the end of this year, said Connecticut State Comptroller Sean Scanlon.
    • “To me, saying we’re not going to cover these anymore was a nonstarter, because these drugs do work. People want to take them,” he said.”
  • The University of Michigan’s employee health benefits program raised the deductible on Wegovy from $20 to $45.
    • “Denmark-based Novo Nordisk charges a list price of $1,349 for roughly a month’s supply of each Wegovy and Saxenda. A related drug, Ozempic, is approved to treat Type 2 diabetes and costs about $930 a month, but isn’t typically covered by insurance plans for weight loss in people without diabetes.” That price differential doesn’t make sense to the FEHBlog.
  • MedPage Today tells us
    • “An investigational vaccine that contains the nucleoprotein of the influenza A virus appeared promising as a universal flu shot that could protect against multiple strains, regardless of annual mutations, a phase IIa dose-finding study showed.”
  • CNN informs us
    • “Artificial intelligence found more breast cancers than doctors with years of training and experience and cut doctors’ mammogram reading workload almost in half, a new early-stage study found.
    • “This doesn’t mean your hospital will let a computer determine whether you have cancer any time soon. There’s still a lot more research to do, but the study, published Tuesday in the journal The Lancet Oncology, shows that AI is safe to use in breast cancer detection and could make doctors even more effective at finding cancer than they are now.”

From the U.S. healthcare front

  • Healthcare Dive reports
    • “CVS Health announced a company-wide restructuring initiative on Wednesday after the healthcare giant’s profit fell 37% year over year to $1.9 billion in the second quarter.
    • “As part of the restructuring, the Woonsocket, Rhode Island-based company plans to terminate certain initiatives. That should allow it to reallocate resources to growth areas like healthcare services and technology, CEO Karen Lynch said on a Wednesday call with investors.
    • “CVS lowered its 2024 adjusted earnings per share target from $9 to between $8.50 and $8.70 as a result of cost pressures — flat from its 2023 guidance range. CFO Shawn Guertin also told investors to “no longer rely” on the company’s target of $10 for 2025.”
  • and
    • “Humana beat Wall Street expectations on earnings and revenue in the second quarter, reporting a topline of $26.7 billion, up 13% year over year, and profit of $959 million, up 38% year over year.
    • “Rising medical utilization earlier in the quarter appears to have stabilized based on recent claims activity, management said. The payer on Wednesday reiterated the 2023 medical loss ratio guidance of between 86.3% and 87.3%.
    • “Humana also raised its Medicare Advantage membership growth expectations following the quarter. The Louisville, Kentucky-based health insurer now expects to add 825,000 MA members in 2023.”
  • Fierce Healthcare relates
    • “Amazon Clinic is expanding to all 50 states, including nationwide telehealth services to offer access to clinicians through its website and mobile app.
    • “The online retail giant unveiled Amazon Clinic back in November as a virtual medical clinic to provide care for 35 common health concerns like urinary tract infection, pink eye, and acid reflux. Launched as a message-based virtual consultation service, Amazon Clinic connects consumers with licensed clinicians who can diagnose, treat and prescribe medication for a range of common health and lifestyle conditions.
    • “The service was available in 34 states and has now been expanded nationwide and to Washington, D.C., along with the addition of video visits with providers on Amazon.com and the mobile app, the company announced in a blog post on Tuesday.
    • “Amazon Clinic is currently cash pay and does not yet accept insurance, the company said.” 
  • Beckers Payer Issues points out
    • “The first wave of UnitedHealthcare’s previously announced 20 percent reduction in prior authorization requirements takes effect Sept 1. 
    • “The remainder of the reductions will occur Nov. 1, according to an Aug. 1 post on UnitedHealthcare’s website. 
    • “The prior authorization code eliminations will take place on Sept. 1 and Nov. 1 for Medicare Advantage, commercial, Oxford, and individual exchange plans. Eliminations for community plans will take place Nov. 1. “
  • and
    • “UnitedHealthcare controls almost one-quarter of the Medicare Part D plan market, according to an analysis from KFF.
    • “The analysis, published July 26, compared market share in 2023 for major payers offering both Medicare Advantage plans and stand-alone Part D plans.
    • “Most payers analyzed, aside from Kaiser Permanente, offer both standalone plans and Medicare Advantage policies, according to KFF. CVS Health, Centene and Cigna have greater enrollment in standalone Part D plans than Medicare Advantage options, while UnitedHealthcare and Humana have more Medicare Advantage members.”
  • Benefits Pro reassures us
    • “When the Affordable Care Act was passed in 2010, it was assumed that many employers would drop workplace health insurance in response. However, a new study by the Employee Benefit Research Institute found that starting in 2015, both the percentage of employers offering health insurance and the percentage of workers eligible for such coverage began to increase.
    • “It should then come as no surprise that the percentage of workers and their families being covered by employment-based health insurance has been relatively steady over the long term,” the report said.”

Monday Roundup

David Ermer–CMS, FDA, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • The American Hospital Association reports
    • “The Centers for Medicare & Medicaid Services released its fiscal year 2024 final rule for the skilled nursing facility prospective payment system. The rule will increase payments by a net 4.0%, or $1.4 billion, in FY 2024 relative to FY 2023 levels. This includes a 3.0% market basket increase which was reduced by a 0.2% productivity cut, increased by a 3.6% market basket forecast error adjustment for FY 2022, and reduced by a 2.3% behavioral adjustment related to the transition to the patient-driven payment model.”
  • and
    • “The Centers for Medicare & Medicaid Services today announced the Guiding an Improved Dementia Experience (GUIDE) Model, a voluntary national Medicare payment model beginning next July that aims to help dementia patients remain at home and improve the quality of life for them and their caregivers. Participating Medicare Part B providers and suppliers will receive a monthly per-beneficiary amount for providing care management and coordination and caregiver education and support services. Certain safety net providers in the new program track will be eligible for a one-time, lump-sum infrastructure payment to support program development activities. CMS is accepting letters of interest through Sept. 15 and plans to release a request for applications this fall.” 
  • HHS issued “a statement applauding the formation of the Office of Long COVID Research and Practice to lead the Long COVID response and coordination across the federal government and, in addition, the National Institutes of Health (NIH) launch of the Long COVID clinical trials through the RECOVER Initiative.”
  • STAT News reports
    • The U.S. Preventive Services Task Force will discuss recommending Covid-19 screening, the first step in requiring insurers to permanently cover the tests at no cost to patients.
    • The national panel of experts will convene and “determine whether and how Covid-19 screening might be considered within the Task Force’s scope,” chair Michael Barry wrote in a letter to Sen. Elizabeth Warren (D-Mass.) exclusively shared with STAT.
    • Conundrum: “However, he reminded them that “our recommendations only apply to people who do not have any signs or symptoms of disease. We are exploring how testing for Covid-19 might fit within the parameters like these that govern the Task Force’s work.”

From the research front —

  • Cardiovascular Business informs us
    • “Researchers at Harvard University have found that a new hydrogel ink, infused with gelatin fibers, makes it possible to 3D print a functional heart ventricle that beats like a human heart. The group shared its findings in Nature Materials, noting that the same technique can be used to 3D print heart valves, dual-chambered hearts and more.[1]
    • “People have been trying to replicate organ structures and functions to test drug safety and efficacy as a way of predicting what might happen in the clinical setting,” first author Suji Choi, PhD, a research associate with the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), said in a prepared statement. 
    • “Creating these complex structures with 3D printing alone has never been possible, Choi et al. explained—until now.”
  • STAT New points out
    • “Unlike today’s crowded market of SSRIs, prescribed once and taken for months, years, or even indefinitely, zuranolone, developed by Sage Therapeutics, promises something different.
    • “It’s a rapid-acting drug, designed to kick in within the first three days of treatment. The patient takes the medication for 14 days, and then stops. Re-dosing occurs on an as-needed basis.
    • “The Food and Drug Administration is expected to decide whether to approve zuranolone for major depressive disorder and for postpartum depression by Aug. 5. And while Meier had a favorable experience with the drug, it has a checkered clinical trial history: a positive outcome, followed by a negative outcome, followed by another positive outcome.
    • “If approved, zuranolone could give psychiatrists something they’ve been looking for: Drugs that provide relief for their patients more quickly. Zuranolone’s mechanism of action, different than that of other antidepressants, also adds a new type of tool — “pliers,” perhaps — to a toolbox that’s full up on “screwdrivers” and “hammers” already, said Olusola Ajilore, a professor of psychiatry at the University of Illinois Center for Depression and Resilience.”
  • The Wall Street Journal reports
    • “Ultrasound, the decades-old technology known for giving early glimpses of unborn babies, could hold a key to a problem that has long challenged drug developers: getting medicines to hard-to-reach places to treat diseases like Alzheimer’s and cancer.
    • “A cutting-edge approach that combines ultrasound waves with tiny bubbles of inert gas injected into the bloodstream can get more chemotherapy to tumor cells and enable drugs to breach one of the most stubborn frontiers in the human body—the blood-brain barrier. It is also being explored as a new way to deliver gene therapy.
    • “There’s an extremely wide variety of where this sort of drug delivery or augmentation with ultrasound and bubbles can take us,” says Flemming Forsberg, professor of radiology and director of ultrasound physics at Thomas Jefferson University in Philadelphia. The effectiveness of drugs in treating diseases like cancer, Alzheimer’s and Parkinson’s is often limited by poor penetration into tissues, he says, whether in the brain or in tumors in other parts of the body.”

From the U.S. healthcare business front —

  • Tenet Healthcare announced its second quarter 2023 financial results today. Per Becker’s ASC Review,
    • “Tenet Healthcare’s second quarter net income hit $123 million, according to its financial report published July 31. 
    • “Here are four more ASC takeaways:
      • “1. Tenet’s $123 million net income in the second quarter of 2023 is an increase of $85 million over the company’s net income in the second quarter of 2022. 
      • “2. Net operating revenues for the company’s ambulatory care segment was $942 million in the second quarter of 2023. 
      • “3. The $942 million number marks a 22.2 percent increase compared to the second quarter 2022 figure — driven by surgical case growth, acquisition and opening of new facilities, service line growth and improved price yielding. 
      • “4. Same-facility systemwide surgical cases were up 6.6 percent in the quarter and 7.2 percent since the start of 2023.” 
  • Fierce Healthcare tells us
    • “Last year, Blues plan giant Anthem unveiled a corporate rebrand as Elevance Health, a move it said better illustrated its ambitions to be more than just a health plan.
    • “Now, the company is updating the branding for its Amerigroup segment to Wellpoint in a bid to better align the government insurance business with its push toward whole health, Elevance Health tells Fierce Healthcare exclusively. The rebrand will roll out in January 2024, pending regulatory approvals, in six states: Arizona, Iowa, New Jersey, Tennessee, Texas and Washington.
    • “Amerigroup plans in Maryland already took on the Wellpoint brand earlier this year. The insurer emphasized that while Amerigroup’s plans may be gaining a new name, the benefits that members enjoy today won’t be changing in tandem.
    • “Felicia Norwood, president of government health benefits for Elevance Health, told Fierce Healthcare that deploying the new name will help “simplify our health plan brands and make it easier for our customers to understand and do business with us over time.”
  • From the patient safety front —
  • STAT News relates
    • “Five elderly people have been blinded in one eye by a severe side effect after receiving injections of a newly approved treatment for eye disease from Apellis Pharmaceuticals. The frequency of this side effect — a severe type of eye inflammation — is low but its cause remains unknown.
    • “The new safety information related to the Apellis drug, called Syfovre, was presented Saturday by a committee of eye disease experts at the annual meeting of the American Society of Retinal Specialists (ASRS).
    • “Apellis cooperated with the ASRS analysis but the company also announced its own internal review Saturday that found fewer cases of retinal occlusive vasculitis, a type of severe eye inflammation that blocks blood flow to the retina and can result in blindness. The rate of retinal occlusive vasculitis reported remains “very rare,” the company said, adding that there is no evidence linking the drug product or its manufacturing to the severe side effect.”
  • The New York Times reports that federal courts have rejected Johnson & Johnson’s bankruptcy defense to the talc class action lawsuits. Johnson & Johnson continues to assert the defense on appeal and elsewhere.

Thursday Miscellany

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

From Washington DC —

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

From the public health front —

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

Following up on FEHBlog posts from earlier this week —

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

From the U.S. healthcare business front —

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

Tuesday Tidbits

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

From Washington, DC —

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

From the public health front —

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

From the U.S. healthcare business front,

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

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

Monday Roundup

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

From Washington, DC

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

Speaking of war, STAT News reports

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

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

From the public health front,

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

In medical and drug research news

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

From the U.S. healthcare business front —

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