Monday Roundup

FDA

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medicare, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC,

  • The Office of Personnel Management issued a Benefit Administration Letter providing guidance about an Enrollee Decision Period for Federal Long Term Care Insurance Program enrollees. The Enrollee Decision Period started today and ends on November 9, 2023.
  • The Food and Drug Administration announced
    • “approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.”
  • Roll Call adds
    • “Advisers to the Centers for Disease Control and Prevention are scheduled to discuss on Tuesday recommendations for who should receive the vaccines and when, with CDC Director Mandy Cohen expected to sign off shortly thereafter. 
    • “Drugmakers say they’re ready to begin shipping the shots immediately in accordance with the CDC’s pending guidelines.”
  • STAT News tells us, “Sen. Bernie Sanders (I-Vt.) will hold a confirmation hearing next month for Dr. Monica Bertagnolli, President Biden’s nominee to run the National Institutes of Health, he said Friday.”

From the public health front,

  • MedPage Today reports
    • “Anesthesiologists are sharply divided over how to handle the growing number of surgical patients on GLP-1 receptor agonists, given that the drugs can raise the risk of aspiration during surgery.
    • “While the leading U.S. anesthesiology society suggests that patients stop taking injectable versions of the medications for 7 days ahead of surgeryopens in a new tab or window, some anesthesiologists are turning to alternative strategies such as intubating all at-risk patients, even for minor procedures.
    • “Other anesthesiologists are calling for patients to stay off the drugs for weeks, not days, or titrate down to lower doses.
    • “This topic is being heavily discussed in the anesthesia community right now, and it’s very polarizing,” Michael Gulak, MD, a resident anesthesiologist at the University of Toronto, told MedPage Today.”

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us
    • “Nonprofit hospital expenses continued to grow last year while liquidity fell to pre-pandemic levels, according to Moody’s Investor Services. 
    • “In a Sept. 7 report, Moody’s outlined 2022 fiscal year trends based on data from 218 health systems. The report noted operating margins fell to”unsustainable levels” as median operating cash flow margin was 4.9 percent and median operating margin was -0.3 percent amid labor shortages and inconsistent patient volumes.
    • “While the industry shows signs of stabilizing in 2023, the labor environment will remain challenging,” the report states.”
  • Per Benefits Pro,
    • “Hospitals in the United States faced unprecedented challenges during the COVID-19 pandemic, and those challenges have left them floundering in the face of increased costs and workforce shortages. According to the most recent Costs of Caring report from the American Hospital Association, this combination of factors has resulted in a 17.5% increase in overall hospital expenses between 2019 and 2022. “Further exacerbating the situation is the fact that the staggering expense increases have been met with woefully inadequate increases in government reimbursement,” the report states, leading to consistently negative margins and over half of hospitals ending 2022 at a financial loss.
    • “Even so, hospital expenses per inpatient day have been steadily trending upwards for years in the U.S., whether for-profit, non-profit, or state/local government. Research from KFF shows that in 1999, the average adjusted expenses per inpatient day for state/local government hospitals was $1,004. Non-profits were at $1,139, and for-profits were at $999. As of 2021, state/local government stands at $2,742—a 173% increase. Non-profits are at $3,013 (164.5%) and for-profits at $2,296 (129.8%).”
  • MedCity News points out
    • While there are fewer rural residents enrolled in Medicare Advantage plans than micropolitan or metropolitan residents, MA enrollment in rural areas is growing much more rapidly, new research shows.
    • The KFF report, published Thursday [September 7], defines rural areas as having less than 10,000 people, micropolitan areas as having 10,000 to 50,000 people and metropolitan areas as having at least 50,000 people. The findings come when Medicare Advantage growth overall is on the rise, accounting for more than half of eligible Medicare beneficiaries in 2023.
  • Healthcare Dive relates
    • Walmart is considering buying a majority stake in value-based medical chain ChenMed, according to a Bloomberg report published Friday.
    • The retail giant is in discussions with ChenMed regarding a transaction that would value the Miami-based primary care clinic operator at several billion dollars, Bloomberg reported, citing sources familiar.
    • Terms of the deal aren’t finalized, and talks could fall through or a different buyer could emerge, Bloomberg’s sources said.
    • If a deal is announced, Walmart would become the latest retail operator to bag a primary care operator, following in the footsteps of rivals including CVS, Amazon and Walgreens.
    • ChenMed operates a network of more than 125 clinics for Medicare-eligible seniors in 15 states, according to the company’s website.

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Government Contracting, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network offers its periodic update on the bills pending before Congress of interest to federal employees.
  • American Hospital Association News tells us that today
    • “The Department of Health and Human Services’ Office for Civil Rights released a proposed rule intended to update and clarify requirements under Section 504 of the Rehabilitation Act that prohibit discrimination on the basis of disability in programs receiving financial assistance from the department, including health care. According to HHS, the proposed rule would ensure that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities; prohibit the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when used to limit access or to deny aids, benefits and services; establish enforceable standards for accessible medical diagnostic equipment; and clarify obligations for accessible web and mobile applications and obligations to provide services in the most integrated setting appropriate to an individual’s needs. The rule will be published in the Sept. 14 Federal Register, with comments accepted for 60 days.”
  • The Federal Times points out
    • “The Office of Personnel Management received a small surge of retirement claims in July and August after applications had been falling steadily for months since January.
    • “The time it took the government to process retirements increased sharply in July to 85 days before falling back down to 74 days in August, according to data kept by OPM.
    • “Overall, the agency is sitting on an inventory of nearly 18,000 cases after it reduced its working caseload to new lows this year. About this time last year, there were 29,000 pending cases.
    • “Still, despite efforts to dispatch focus teams to address backlogs, the agency is failing to hit its target time or inventory goals, leaving retirees to wonder whether their case will be one that ends up sitting in limbo for longer. Ideally, retirement applications are processed in 60 days or fewer.”
  • CMS released its 2022 report on covered entity compliance with the HIPAA electronic transactions.
    • The transaction types experiencing the most violations during the 2020 and 2021 compliance reviews were specific to 835 [the claim transaction], 271 [Health Care Eligibility Response], and 277 [Claim Status Response] transactions. This changed slightly in 2022 as the most common transaction types experiencing violations are now 835, 271, and 834 [EOB] transactions.
    • CMS is sharing updated 2022 violation findings insights to inform and educate the industry, encourage widespread compliance, and assist covered entities with preparing for compliance reviews.
  • The Society for Human Resource Management relates,
    • The U.S. Equal Employment Opportunity Commission (EEOC) has released an updated deadline for employers to submit their demographic data. The EEO-1 Component 1 data collection for 2022 will start on Oct. 31, and the deadline for employers to file their EEO-1 reports is Dec. 5.
    • All private employers that have at least 100 employees are required to file the EEO-1 form annually, detailing the racial, ethnic and gender composition of their workforce by specific job categories.
    • Likewise, federal government contractors and first-tier subcontractors with 50 or more employees and at least $50,000 in contracts must file EEO-1 reports. State and local governments and public school systems are exempt.
  • KFF reports
    • “Over the past two years, the federal government has provided about $1 billion from the American Rescue Plan and Bipartisan Safer Communities Acts to launch the number, designed as an alternative to 911 for those experiencing a mental health crisis. After that infusion runs out, it’s up to states to foot the bill for their call centers.
    • “We don’t know what Congress will allocate in the future,” said Danielle Bennett, a spokesperson for the federal Substance Abuse and Mental Health Services Administration, which oversees 988. “But the hope is that there will be continued strong bipartisan support for funding 988 at the level it needs to be funded at and that states will also create funding mechanisms that make sense for their states.”
    • “Only eight states have enacted legislation to sustain 988 through phone fees, according to the National Alliance on Mental Illness, which is tracking state funding for the system. Others have budgeted short-term funding. But many predominantly rural states, where mental health services are in short supply and suicide rates are often higher than in more urban states, have not made long-term plans to provide support.”
  • MedPage reports,
    • When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, it left oral phenylephrine (with brands including Sudafed PE and Suphedrine PE) as the only nasal decongestant available without pharmacy assistance. But there’s one big problem: phenylephrine doesn’t work, the FDA has finally determined.
    • FDA reviewers released the results of their long-running review of the evidence this week as background for a meeting of the Nonprescription Drugs Advisory Committee to be held on September 11 and 12.
    • The article explains the conundrum this finding creates for the FDA.

From the public health front,

  • MedPage reports that “the global incidence of early-onset cancer has increased by 79% over the past three decades, researchers reported.
    • “In a comment posted on Science Media Centre, Dorothy C. Bennett, MA, PhD, of St. George’s, University of London, cautioned that the increase in new cases of early-onset cancer is based on absolute numbers, rather than age-standardized rates.
    • “The world human population increased by 46% between 1990 and 2019, which explains part of the increase in total case numbers,” she said, adding that the increase in numbers of cancer deaths in this age group (28%) was notably lower than the number of new diagnoses, “which is below the increases in total population and case numbers, indicating a fall in the average cancer death rate in this group.”
  • Per the American Heart Association,
    • Obesity-related cardiovascular disease deaths tripled between 1999 and 2020 in the U.S.
    • Such deaths were higher among Black individuals (highest among Black women) compared with any other racial group, followed by American Indian/Alaska Native people.
    • Black adults who lived in urban communities experienced more obesity-related cardiovascular disease deaths than those living in rural areas, whereas the reverse was true for all other racial groups.
  • McKinsey Health offers a podcast about getting to the bottom of the teen health crisis.

From the U.S. healthcare business front,

  • Fierce Healthcare notes, “Employers’ health benefits costs are set to rise 5.4% next year, but this spike isn’t as high as may have been feared given inflationary pressures in the broader economy, according to a new analysis from Mercer.”
  • STAT News interviews “Amazon’s chief medical officers on where the company’s health care bets are headed next.”
  • Healthcare Dive informs us,
    • “Telehealth sessions comprised 5.4% of claim lines in June, the same amount as the prior month, according to Fair Health’s Monthly Telehealth Regional Tracker.
    • “Mental health conditions continued to top the list of Fair Health’s five most common telehealth diagnoses for June. The median allowed amount billed for a one-hour psychotherapy visit was $103.
    • “But Fair Health’s tracker showed regional variations. Although telehealth use decreased overall by 2.4% in the Midwest, asynchronous telehealth claim lines for mental health conditions more than doubled in the region from 15.9% in May to 36% in June. In asynchronous telehealth, providers collect data or medical images for review, instead of meeting with a patient in real time.” 
  • Per Health Affairs,
    • “Intensive care units (ICUs) are increasingly used for hospital care, yet out-of-pocket spending for ICU hospitalizations remains poorly understood, particularly among the nearly half of the US population with commercial health insurance. Using 2008–19 MarketScan data, we compared 1,441,810 hospitalizations involving ICU services with 13,011,208 hospitalizations that did not involve ICU services.
    • “Average cost sharing, adjusted for patient and admission factors, increased from $1,137 per hospitalization in 2008 to $1,539 in 2019, or a 34 percent increase. This was driven by increasing deductibles, which rose by 163 percent.
    • “Across twenty clinical conditions whose hospitalizations commonly occurred in both ICU and non-ICU settings, ICU admission was associated with $155 higher cost-sharing (13.0 percent higher) relative to cost sharing in non-ICU hospitalizations.
    • “Patients with high-deductible plans faced the highest cost-sharing relative to those with other plan types.
    • “Patients who received out-of-network hospital care encountered higher cost-sharing relative to those admitted to in-network hospitals with in-network clinicians.”

Midweek update

David Ermer–FDA, Generative AI, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC,

  • “Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra declared a Public Health Emergency (PHE) for the state of Florida to address the health impacts of Hurricane Idalia and the Administration for Strategic Preparedness and Response (ASPR) deployed approximately 68 emergency response personnel to the state. At President Biden’s direction, HHS is aiding impacted communities through the Administration’s whole-of-government response effort.”
  • The Society for Human Resource Management informs us,
    • “The Department of Labor (DOL) has proposed an increase to the Fair Labor Standards Act’s (FLSA’s) annual salary-level threshold to $55,068 from $35,568 for white-collar exemptions to overtime requirements. The department also is proposing automatic increases every three years to the overtime threshold. * * * *
    • “To be exempt from overtime under the FLSA’s “white-collar” executive, administrative and professional exemptions, employees must be paid a salary of at least the threshold amount and meet certain duties tests. If they are paid less or do not meet the tests, they must be paid 1 and a half times their regular hourly rate for hours worked in excess of 40 in a workweek. * * *
    • “Under the new rule, approximately 300,000 more manufacturing workers would be entitled to overtime pay, the Labor Department reports. A similar number of retail workers would be eligible, along with 180,000 hospitality and leisure workers, and 600,000 in the health care and social services sector.” 
  • MedCity News relates,
    • “A Bristol Myers drug that treats anemia caused by a type of blood cancer now has an FDA approval that moves it up in the hierarchy of treatments, expanding the eligible patient population and positioning the therapy to achieve its blockbuster expectations.
    • “The drug, Reblozyl, treats myelodysplastic syndromes (MDS), a group of cancers in which the immature blood cells in bone marrow do not mature to become healthy blood cells. In 2020, the FDA approved Reblozyl as a second-line treatment for the anemia resulting from MDS. The FDA decision announced late Monday makes it a first-line therapy.”
  • The National Institutes of Health announced,
    • “In a study of 152 deceased athletes less than 30 years old who were exposed to repeated head injury through contact sports, brain examination demonstrated that 63 (41%) had chronic traumatic encephalopathy (CTE), a degenerative brain disorder associated with exposure to head trauma. Neuropsychological symptoms were severe in both those with and without evidence of CTE. Suicide was the most common cause of death in both groups, followed by unintentional overdose.
    • “Among the brain donors found to have CTE, 71% had played contact sports at a non-professional level (youth, high school, or college competition). Common sports included American football, ice hockey, soccer, rugby, and wrestling. The study, published in JAMA Neurology, confirms that CTE can occur even in young athletes exposed to repetitive head impacts. The research was supported in part by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.” 

From the public health, medical research and Rx coverage fronts,

  • STAT News reports,
    • “The first Alzheimer’s therapy to clearly slow cognitive decline, approved in the United States last month, lifted the hope of patients and their families. But creating access to the program is a painfully slow process, even in Massachusetts, where large hospital systems have been preparing for months to administer the much-anticipated medicine.
    • “Thousands of patients are stuck on waiting lists across the state and nationally as hospitals struggle to ramp up infusion centers and monitoring processes for the drug, called Leqembi, while neurologists grapple with workforce and capacity constraints. * * *
    • “Hospitals say the backlog is temporary, reflecting the challenge of building from scratch a treatment infrastructure for new Alzheimer’s drugs. Leqembi, developed by Biogen and its Japanese partner, Eisai, was the first such treatment to be green-lighted by the Food and Drug Administration. The agency will evaluate a second therapy, Eli Lilly’s donanemab, later this year.”
  • and
    • “KRAS, one of the most common genetic mutations in cancer, has been one of the most tantalizing oncogenic targets for drug developers since its discovery four decades ago. An altered KRAS gene can drive cells to divide uncontrollably, propelling them down the path towards malignancy. But for most of the last four decades, any attempt to target KRAS failed, leading many researchers to doom the protein as “undruggable.”
    • “In the last few years, that attitude has sharply turned around. In 2013, Kevan Shokat, a biologist at the University of California, San Francisco, discovered a key chemical vulnerability in a specific subset of mutant oncogenic KRAS that made it possible to design small molecules that would bind to the protein. This discovery catalyzed a frenzy of drug development around KRAS inhibitors, which eventually led to the first approved KRAS drugs in the last couple of years. Those successes are now driving a new wave of early-stage innovation around the target.
    • “It broke the code for us, for KRAS,” said Ravi Salgia, chair of medical oncology and therapeutics research at the City of Hope. “That gives us more hope to say we’ve spent more than 30 years studying it. Now, great breakthroughs have occurred. Let’s keep going forward.”
    • “That includes work around new small molecules for other subsets of mutant KRAS as well as immunotherapy approaches for targeting the oncogene. These therapies could potentially treat a wide range of different KRAS-mutant cancers including lung, pancreas, and colorectal cancers.”
  • CNN tells us,
    • “A group of novel synthetic opioids emerging in illicit drugs in the United States may be more powerful than fentanyl, 1,000 times more potent than morphine, and may even require more doses of the medication naloxone to reverse an overdose, a new study suggests.
    • “Nitazenes are a synthetic opioid, like fentanyl, although the two drugs are not structurally related. In the small study published Tuesday in the journal JAMA Network Open most of the patients who overdosed on nitazenes received two or more doses of the opioid overdose reversal drug naloxone, whereas most patients who overdosed on fentanyl received only a single dose of naloxone.
    • “Clinicians should be aware of these opioids in the drug supply so they are adequately prepared to care for these patients and anticipate needing to use multiple doses of naloxone,” the researchers, from the Icahn School of Medicine at Mount Sinai in New York, Lehigh Valley Health Network based in Pennsylvania, and other US institutions, wrote in the study. “In addition, to date there has been a lack of bystander education on repeat naloxone dosing.”

From the U.S. healthcare business front,

  • Per Healthcare Dive, and the FEHBlog agrees,
    • “Ensuring workers can find and access high-quality providers is key to tamping down healthcare costs and improving outcomes in the employer-sponsored insurer market, according to a study by Morgan Health and Embold Health published in NEJM Catalyst. 
    • “Employers can now access more data on the quality of care provided by clinicians, so they should take a larger role in health plan network design and steer workers toward higher-performing providers, according to the report. 
    • “Clinician quality can drive poor outcomes, missed treatments and unnecessary care, the report said. For example, among the top 10% of about 800 cardiologists in Ohio by quality rank, an average of 73% of patients with coronary artery disease were taking cholesterol-lowering statins regularly, compared with only 39% for the bottom 10% of clinicians.” 
  • The Wall Street Journal reports
    • “In a male-dominated industry, female surgeons spend more time in the operating room, and their patients endure fewer postoperative complications.
    • “That’s the conclusion of two research studies published Wednesday in JAMA Surgery. Researchers found better outcomes for patients treated by female surgeons in the sweeping reviews of millions of procedures in Canada and Sweden. 
    • “In the first study, 17 researchers in the U.S. and Canada followed the outcomes for 1.2 million patients in Canada undergoing common surgeries between 2007 and 2020.
    • “The study authors found that at both 90 days and one year following surgery, patients treated by female surgeons were less likely to experience adverse postoperative issues, including death. The outcome differences were modest, but consistent.”
  • Fierce Healthcare relates,
    • “Earlier this year, Anthem Blue Cross and Blue Shield unveiled a new virtual-first plan that harnesses artificial intelligence to streamline health services for members, the insurer announced.
    • “Now, it’s making that plan available in several additional states beginning Jan. 1. Large group fully insured or self-funding employer clients in Connecticut and Virginia can select Anthem Link Virtual First plans, which harness the power of the insurer’s Sydney app to connect members with benefits details, cost transparency information and more around the clock.
    • “Stephanie DuBois, a spokesperson for Anthem Blue Cross and Blue Shield in Connecticut, told Fierce Healthcare in an email that the plans first became available to large group self-insured employers in California, Missouri and New York as well as large group self-funded and fully insured employers in Georgia starting in July.
    • “Members can access Anthem Link Virtual First plans through Sydney Health, which is a digital member engagement platform that includes access to benefits, tools, resources and provider care 24/7,” DuBois said. “Sydney Health also offers an AI-driven symptom checker that intuitively uses the information members provide to narrow down millions of medical data points and assess specific symptoms before seeing a doctor.”

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.”

Quick Takes

David Ermer–ACA, CDC, CMS, FDA, Medicare, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Mercer Consulting informs us,
    • “The Affordable Care Act (ACA) benchmark for determining the affordability of employer-sponsored health coverage will drop significantly to 8.39% of an employee’s household income for the 2024 plan year — down from the 2023 plan-year level of 9.12%, according to IRS Rev. Proc. 2023-29. This affordability percentage can affect individuals’ eligibility for federally subsidized coverage from a public exchange, as well as employers’ potential liability for shared responsibility (or “play or pay”) assessments. Importantly, employers that use the exact safe harbor dollar amount to set employee contributions will need to reduce the current employee contribution for the lowest-cost, self-only option for the 2024 plan year.”
  • The Food and Drug Administration has “approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).”
  • Per the American Hospital Association
    • The Centers for Disease Control and Prevention Aug. 24 announced the launch of its Hospital Sepsis Program Core Elements initiative, a new program to provide hospitals with a blueprint for managing medical emergencies stemming from sepsis. The program, which is modeled after a similar effort for antibiotic stewardship, is intended as a “manager’s guide” to organizing staff and making the resources available to improve sepsis care and bring survival rates up.”
  • CMS tells us that
    • “The Medicare Shared Savings Program saved money for Medicare while continuing to support high-quality care. Specifically, the program saved Medicare $1.8 billion in 2022 compared to spending targets for the year. This marks the sixth consecutive year the program has generated overall savings and high-quality performance results. This represents the second-highest annual savings accrued for Medicare since the program’s inception more than ten years ago.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • Cigna is the latest health insurer to roll back prior authorization requirements, announcing Thursday that it will no longer require the approvals for nearly 25% of medical services.
    • Cigna plans to remove more than 600 prior authorization codes in its commercial plans, bringing Cigna’s total prior authorization removals to more than 1,100 since 2020, the payer said.
    • Cigna plans to nix another 500 or so codes for its Medicare Advantage plans before the end of this year.

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.”

Tuesday Tidbits

David Ermer–CDC, Electronic health records, FDA, Generative AI, Medicare, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healio informs us,
    • “An FDA panel voted that for adults with uncontrolled hypertension, the benefits of an ultrasound renal denervation device outweigh its risks.
    • Concerns about long-term durability of effect were expressed.”
  • The Department of Health and Human Services announced
    • “award[ing] more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19 for years to come.
    • “The awards announced today follow extensive coordination with industry partners and include support for clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes.”
  • The U.S. Preventive Services Task Force reaffirmed its 2019 Grade A recommendation that “clinicians prescribe preexposure prophylaxis using effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV.”
  • The Centers for Disease Control lets us know, based on a survey,
    • About 20% of women reported mistreatment while receiving maternity care.
    • About 30% of Black, Hispanic, and multiracial women reported mistreatment. 
    • Almost half (45%) of women held back from asking questions or sharing concerns during their maternity. * * *
    • Mistreatment was reported most often by Black, Hispanic, and multiracial moms and those with public insurance or no insurance.
  • That’s a big bowl of wrong. The CDC observes,
    • Respectful maternity care is free from harm and mistreatment, maintains privacy, confidentiality, and dignity, and allows for shared decision-making and continuous support.
  • The Department of Justice announced yesterday,
    • [“D]eferred prosecution agreements resolving criminal antitrust charges against Teva Pharmaceuticals USA, Inc. and Glenmark Pharmaceuticals Inc., USA. As part of those agreements, both companies will divest a key business line involved in the misconduct, and as an additional remedial measure, Teva will make a $50 million drug donation to humanitarian organizations. Teva will pay a $225 million criminal penalty — the largest to date for a domestic antitrust cartel — and Glenmark will pay a $30 million criminal penalty. Both companies will face prosecution if they violate the terms of the agreements, and if convicted, would likely face mandatory debarment from federal health care programs.
    • “The agreements each require the companies to undertake remedial measures, including the timely divestiture of their respective drug lines for pravastatin, a widely used cholesterol medicine that was a core part of the companies’ price-fixing conspiracy. This extraordinary remedy forces the companies to divest a business line that was central to the misconduct. Teva must also donate $50 million worth of clotrimazole and tobramycin, two additional drugs with prices affected by Teva’s criminal schemes, to humanitarian organizations that provide medication to Americans in need. Both Teva and Glenmark have agreed, among other things, to cooperate with the department in the ongoing criminal investigations and resulting prosecutions, report to the department on their compliance programs, and modify those compliance programs where necessary and appropriate.” 
  • Federal New Network reports that OPM released guidance for hybrid teleworkers who are covered under the Fair Labor Standards Act.
  • The Equal Employment Opportunity Commission released its new strategic plan for fiscal years 2022 through 2026
    • “The new Strategic Plan reflects our thoughtful assessment of the agency’s mission, goals, and objectives in light of current conditions and what we expect in the next few years,” said EEOC Chair Charlotte A Burrows. “It emphasizes expanding the EEOC’s capacity to eliminate systemic barriers to equal opportunity in the workplace, using technology and other tools to improve our services to the public, and achieving organizational excellence with a culture of accountability, inclusivity, and accessibility. I am grateful for the hard work of our staff across the agency who assisted in developing this plan and look forward to its successful implementation.”.

From the public health front,

  • The Washington Post explains
    • how to address the factors that may underlie the growing number of women under age 40 who are afflicted with breast cancer,
  • and
    • how to guard against germs in leafy green salads.

From the U.S. healthcare business front,

  • The FEHBlog was surprised to read in the Wall Street Journal that
    • “America’s nursing homes are fading away.
    • “The U.S. has at least 600 fewer nursing homes than it did six years ago, according to a Wall Street Journal analysis of federal data. More senior care is happening at home, and the Covid-19 pandemic caused many families to shun nursing homes while draining workers from an already short-staffed industry.
    • “The result? Frail elderly patients are stuck in hospitals, a dangerous place for seniors, waiting for somewhere to go—sometimes for months. Beds are disappearing while the need for senior care is growing. The American population 65 and older is expected to swell from 56 million in 2020 to 81 million by 2040.
  • MedPage Today notes.
    • “States that recently adopted less-restrictive policies surrounding the use of telepharmacy had fewer pharmacy deserts in the following year, a cohort study involving a dozen states showed.
    • “Compared with nearby states that made no changes, states that formally implemented or updated pro-telepharmacy policies had a 4.5% relative decrease (95% CI 1.6-7.4) in the percentage of regions defined as pharmacy deserts (P=0.001) and an 11.1% relative decrease (95% CI 2.4-22.6) in the proportion of people living in one of these deserts (P=0.03).
    • “And in general, telepharmacies tended to serve areas of high medical need, reported Jessica Adams, PharmD, of TelePharm in Iowa City, Iowa, and colleagues.
    • “As pharmacy closures and socioeconomic factors persist, pharmacy deserts are likely to expand unless policies are implemented to ensure continued access to pharmacy services,” the researchers wrote in JAMA Network Open
  • The Business Group on Health points out,
    • “Mental health needs among workforces continued to climb this year, with 77% of large employers reporting an increase and another 16% anticipating one in the future, according to Business Group on Health’s 2024 Large Employer Health Care Strategy Survey.
    • “This represents a 33 percentage-point surge over last year, when 44% of employers saw an increase in employee mental health concerns.
    • “The Business Group survey, released today in Washington, DC, also showed that cancer was still the top driver of large companies’ health care costs while rising prescription drug costs also proved to be a leading concern. Cancer overtook musculoskeletal conditions last year as the top driver of large companies’ healthcare costs and shows no sign of abating in the coming years.
    • “Yet as businesses respond to the increase in mental health needs, grapple with soaring health care costs and address issues of health equity and affordability, they will continue to invest strategically in diverse health and well-being offerings for the upcoming year, the survey also showed.”
  • Axios reports that “Middle-class Americans [who earn $50,000 to $100,000 annually] are the most likely to be saddled with medical debt, with nearly 1 in 4 — or roughly 17 million people — having unpaid medical bills, according to a report shared first with Axios from center-left think tank Third Way.”
  • Per Healthcare Dive,
    • “Epic and Microsoft announced on Tuesday an expanded collaboration focused on integrating generative artificial intelligence tools in the vendor’s electronic health records system. 
    • “The partners are working to “rapidly deploy dozens” of AI technologies, including clinical note summarization, medical coding suggestions and data exploration tools that aim to fill gaps in clinical evidence by using real-world data. 
    • “The expanded partnership is intended to speed the development of AI tools in healthcare, bringing the technology as “quickly as possible, responsibly and in partnership with providers,” according to a blog post by Eric Boyd, corporate vice president of AI platform at Microsoft.”

Monday Roundup

David Ermer–CMS, FDA, HSA, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • ‘A vaccine that federal regulators approved on Monday could help make the most severe cases of a dangerous respiratory illness in infants a thing of the past. 
    • ‘The Food and Drug Administration approved the first vaccine for pregnant women to protect their babies against respiratory syncytial virus during their first six months. RSV is the leading cause of infant hospitalization in the U.S. and kills as many as 300 children under 5 years old each year. 
    • ‘Pfizer’s vaccine, called Abrysvo, gives parents another way to protect their newborns, after Sanofi’s drug Beyfortus won approval in July. The FDA earlier this year also cleared a pair of RSV shots from Pfizer and GSK to protect older adultsfrom RSV. Until now, most children had to fight off infections on their own. Only babies at high risk for severe disease are eligible for a drug from the company Sobi. 
    • “We’re sort of going from famine to feast,” said Dr. Kristin Moffitt, an infectious-disease specialist at Boston Children’s Hospital. “These are huge game changers for what has typically been the most common cause of hospitalization for young infants in the U.S.” 
  • Health Payer Intelligence relates,
    • “CMS has released draft guidance detailing a new program allowing Medicare beneficiaries to pay out-of-pocket Part D costs in monthly installments.
    • “The Medicare Prescription Payment Plan is required under the Inflation Reduction Act and will take effect in 2025.
    • “The program mandates Medicare Part D plan sponsors to offer Part D beneficiaries the option to pay their out-of-pocket costs for prescription drugs monthly over a year instead of at the point of sale. Part D sponsors must pay the pharmacy the out-of-pocket cost-sharing beneficiaries would have paid if they were not in the program. Sponsors will then bill beneficiaries monthly for the cost-sharing.
    • “The program is available to all Medicare Part D beneficiaries, but CMS indicated that those incurring high out-of-pocket costs earlier in the plan year are more likely to benefit from the payment plan. The agency will develop tools to help beneficiaries decide if the program will be helpful.
    • “While the program will not reduce beneficiaries’ overall out-of-pocket costs, spreading the costs throughout the year can help ease some cost-sharing burden, CMS said. Additionally, beneficiaries will owe $0 upfront when picking up medication at the pharmacy.”

From the public health front,

  • Health Leaders Media tells us,
    • “Innovation in pediatric healthcare often focuses on the tiniest of factors affecting the tiniest of patients. And Tanja Gruber, MD, PhD, says research around the makeup and functions of the gene are enabling care providers to get a better idea of how to tackle cancer.
    • “HealthLeaders recently sat down—virtually—with Gruber, chief of pediatric hematology, oncology, and stem cell transplantation at Stanford Medicine Children’s Health to discuss innovative ideas like immunotherapy, stem cell transplants, gene therapy, and gene editing, and how they’re helping to improve outcomes for millions of children.”
    • Check it out.
  • Per the Washington Post,
    • In a study presented at the annual meeting of the American Society for Nutrition, researchers found that men who had adopted all eight habits by middle age lived 24 years longer than men whose lifestyle included few or none of the habits. Women’s life expectancy increased by 23 years for those who had adopted the eight habits compared with women who had not.
    • The study was based on data from nearly 720,000 U.S. veterans 40 and older, which is considered a nationally representative sample. Described by the researchers as “therapeutic lifestyle factors,” the eight key habits were:
      • Not smoking.
      • Being physically active.
      • Managing stress.
      • Eating a healthy diet.
      • Having good sleep hygiene.
      • Avoiding binge drinking.
      • Not being addicted to opioids.
      • Having positive social relationships.

From the U.S. healthcare business front,

  • STAT News informs us,
    • “To much of the public, the promise of telehealth is all about convenience — get the prescription you need quickly, and get it delivered right to your door. But as digital health companies build out their weight loss businesses, capitalizing on the popularity of drugs like Wegovy and Ozempic, they’re courting a very different audience: payers and employers who have a vested interest in preventing quick scripts.
    • “Payers are reeling as they try to figure out how to sustainably cover GLP-1 receptor agonists, a class of remarkably effective but expensive obesity and type 2 diabetes drugs. So in the last six months, digital health companies, including Teladoc, Found, Hello Alpha, and Calibrate, have advanced enterprise products that pair virtual visits and prescriptions with lifestyle coaching. Their hope is that more and more payers and employers will offer their programs as a way to support lasting weight loss and metabolic health — or even require them if patients want their drugs reimbursed.”

From the human resources front,

  • CFO reports,
    • [A]ccording to a study released on Monday, a newer type of account — “lifestyle spending accounts,” or LSAs — has quickly become the most common employer-funded perquisite. (Unlike FSAs and HSAs, LSAs are categorized as perks because they’re funded solely by employers and are considered taxable income for employees.) * * *
    • LSAs differ from HSAs and FSAs in another key respect — employees can use them for many types of spending needs, as determined by the employer. These could include health-related purchases such as gym memberships, nutritionists, and health-care coaching, as well as spending on, for example, learning and development, family activities, commuting, pets, or charitable giving.
  • HR Morning identifies “five ways to help employees who are mental health caregivers.” Aren’t we all mental health caregivers to some extent?

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.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, FDA, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • Roll Call reports,
    • “House Republicans are planning to take up a short-term stopgap funding measure next month to avoid a partial government shutdown, Speaker Kevin McCarthy, R-Calif., told members of his conference during a Monday night call, sources familiar with the conversation said. 
    • “The continuing resolution is expected to extend current funding until early December, giving lawmakers a few extra months past the Sept. 30 deadline to complete fiscal 2024 appropriations. McCarthy said Monday that he did not want to have a continuing resolution run up to the Christmas recess, sources said. 
    • “The speaker’s announcement, which came as little surprise, served as an acknowledgment that the clock had run out for completing appropriations on time for the fiscal year that begins Oct. 1.”
  • Govexec says,
    • “Although President Biden and congressional appropriators appear to be in accord on the White House’s plan to grant federal employees their largest annual raise in more than two decades in 2024, there is still work to be done to make it a reality.
    • “Biden first proposed an average 5.2% pay increase for civilian federal workers and members of the military next year when he unveiled his fiscal 2024 budget plan. That figure marks the highest annual pay increase federal employees have seen since President Carter authorized a 9.1% raise in 1980.
    • “And although the administration and Senate Democrats have been butting heads with GOP appropriators in the House on a variety of funding issues in recent months, neither the House nor the Senate have included language in their respective spending packages to overrule the pay raise plan.”
  • The article explains the legal steps that the President must take this year to implement his pay raise plan.
  • Federal News Network informs us,
    • “In another effort to try to usher young talent into the federal workforce, the Office of Personnel Management is proposing changes to decade-old parameters for the Pathways Program.
    • “The new proposed regulations from OPM, in part, look to expand eligibility for the recent graduates’ Pathways Program, to include individuals who may not have a college degree, but who have completed different “technical education programs.” By counting experience in the Peace Corps, AmeriCorps, Job Corps and the Registered Apprenticeship Program, OPM said it hopes to make the program overall more inclusive, and help agencies attract a broader, more diverse pool of early-career applicants.”
  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) recently published new changes to further advance health equity and increase participation under the ACO REACH model.
    • “National Association of ACOs President and CEO Clif Gaus said the changes will “satisfy many concerns and stabilize future participation.” * * *
    • “Currently, there are 132 participants under ACO REACH, a value-based care model that began in January and replaced the Direct Contracting Model. The new model pushes providers to form accountable care organizations, or ACOs, for fee-for-service Medicare enrollees, and allows for providers to take on more financial risk. Participants are required to implement a health equity plan identifying disparities in care.”
  • A STAT News explains,
    • “The Inflation Reduction Act passed and signed into law a year ago attempts to deal with high drug prices paid by the U.S. government, allowing Medicare to negotiate the prices of some medicines after they have been on the market for years. (Industry would say it’s not negotiation but price-fixing.) But while the IRA is desperately needed — branded medicines cost 2.4 times more in the U.S. than in other developed countries, according to the RAND Corporation — there are ways in which it makes the situation worse.
    • “Here is the problem. The process of testing new experimental medicines takes a long time, sometimes a decade or more, and it is much longer for some objectives, such as preventing heart attacks, than others, like slightly extending the lives of terminal cancer patients.
    • “If one got to design a drug-pricing system from a blank slate, allowing drug prices to spike and then be cut after a few years would look less than ideal. It would be far better to set a lower price at the outset and not raise it but to allow a company to sell a drug for longer so the manufacturer has an incentive to fully study the benefits and risks of its medicines. * * *
    • “There are alternative models of how the drug pricing system can work. Take vaccines, for instance. They are not made nearly as expensive as, say, cancer drugs. But, in most cases, drug companies can trust that the market for them will be long and stable.
    • “This brings us back to the cancer drug shortage. All of the medicines in shortage are treatments that are generic, made into commodities by Hatch-Waxman. This problem could be changed if, say, hospitals were in a position to pay more to manufacturers who were seen as having a more stable supply.
    • “All of it is a reminder that the health care system in the U.S. is a Rube Goldberg machine created by past decisions that were made as much out of expediency as sober planning. The IRA, in particular, is another one of these decisions, pushed through a partisan Congress after the pharmaceutical lobby spent decades avoiding real change. It’s not surprising that a bill that has to be ushered in along partisan lines is not fully thought out or that many of the details are left to bureaucrats.
    • “At some point, we might want to actually design something sensible. Until then, we’d be better served by being more conscious of the mess we’re in.”

From the public health front —

  • Medscape points out,
    • “The newest version of the COVID-19 vaccine will be available by the end of September, according to the CDC. 
    • “The updated vaccine still needs final sign-offs from the FDA and the CDC.
    • “We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast last week hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
    • “For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6 to 8 months since their last dose. For all other people, it’s OK to wait for the new version.”
  • AHA News adds,
    • “Receiving a COVID-19 mRNA vaccine or booster during pregnancy can benefit pregnant people and their newborn infants, according to findings from a federally funded study published in Vaccine. The study looked at 167 pregnant people who received a primary or booster vaccine, which generated antibodies that crossed to the cord blood and likely conferred some protection in their newborns. Participants who received a booster dose had substantially more antibodies in their own blood and in their cord blood, suggesting that boosting increased their newborns’ immune defenses against COVID-19.
  • STAT News reports
    • “Every year, doctors get better tools to fight cancer. Engineered cancer-killing cells, immunotherapies, targeted drugs, and more are helping clinicians cure more patients. Increasingly, though, oncologists are trying to use less radiation, long one of the main pillars of cancer therapy. In some cases, they are even keeping certain patients with low-risk tumors off radiation entirely.
    • “We are in an era of radiation omission or de-escalation,” said Corey Speers, vice chair of radiation oncology at the University Hospitals Seidman Cancer Center and Case Western Reserve University. “Radiation is perhaps one of the most precise and most effective cancer therapies we have, so it will always play an important role in cancer management, but there are situations now on an individual patient basis where radiation may not be needed.”
  • MedPage Today notes that “Incident dementia was tied to exposure to fine particulate matter, especially air pollution from wildfires and agriculture, an observational study of 28,000 adults over age 50 suggested.”

From the judicial front,

  • A unanimous panel of the U.S. Court of Appeals for the 10th Circuit ruled today that ERISA and Medicare Part D preempt certain provisions of an Oklahoma PBM reform law that purport to apply to contracts between PBMs and ERISA and Part D plans. The opinion is helpful to the FEHB Program because the “relates to” clause in the ERISA state law preemption clause, 29 U.S.C. Sec. 1144, is read. analogously or “in pari materia” with the “relates to” clause in the FEHB Act’s state law preemption clause, 5 U.S.C. Sec. 8902(m)(1). Hopefully, this new precedent will pick up steam for ERISA and FEHB preemption of state laws, which do help control premiums.

From the Rx coverage front,

  • Healthcare Dive relates
    • “Amazon on Tuesday added more than 15 new manufacturer-sponsored coupons for insulin brands and diabetes care products to its online pharmacy.
    • “The additions bring Amazon’s manufacturer coupons that are automatically applied during check-out for eligible customers to 36.
    • “The new coupons include some of the most commonly prescribed products from drugmakers including Novo Nordisk, Eli Lilly and Sanofi, including insulin vials, pens and continuous glucose monitors, according to a blog post on Amazon’s website.
  • BioPharma Dive calls attention to
    • “Radiopharmaceuticals for cancer: Making radiation precise
    • “More than a dozen startups are developing drugs that deliver a dose of radiation directly to tumors. Here’s where they stand, and why their progress is worth watching.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans informs us,
    • “U.S. corporate employers project a median healthcare cost increase of 7% for 2024, according to International Foundation of Employee Benefit Plans survey results. The 7% increase is on pace with cost trends projected last year in a similar survey conducted by the International Foundation.
    • “Plan sponsors shared their thoughts on the primary reasons contributing to a rise in medical plan costs for 2024. The top four responses are:
      • 22%—Utilization due to chronic health conditions (up from last year)
      • 19%—Catastrophic claims (same percentage as last year)
      • 16%—Specialty/costly prescription drugs/cell and gene therapy (new in the top four this year)
      • 14%—Medical provider costs (up from last year).
      • The effects of the pandemic appear to be waning as only 4% of responding employers indicated that the primary reason for cost increases is utilization due to delayed preventive/elective care during the pandemic (down from 12% last year).”
    • These factors will be largely offset by Medicare savings for those FEHB plans that are offering Medicare Part D plans for 2024, in the FEHBlog’s view.
  • Health Payer Intelligence explains,
    • “How Payers Are Reducing Prior Authorizations, Limiting Care Disruptions
    • “To limit patient care disruptions, payers have reduced prior authorization requirements for genetic testing, cataract surgeries, and physical therapy.”
  • and reports
    • “Payers prefer to utilize claims and administration platforms from vendors that are efficient, manage multiple business lines, and can meet their complex needs, according to a KLAS report.
    • “The Payer Claims & Administration Platforms 2023 report includes KLAS Decision Insights data and KLAS performance data, which reflects information about vendors and feedback from healthcare organizations.
    • “Among 28 payer organizations, 14 considered using HealthEdge’s claims and administration solutions. The vendor received an overall performance score of 76.5 on a 100-point scale. Twelve organizations considered using Cognizant, which received a score of 74.7.”
  • Healthcare Dive relates
    • “More than three years after the onset of the COVID-19 pandemic, only 1% of primary care clinicians surveyed by the Larry A. Green Center and the Primary Care Collaborative believe their practice has fully recovered from its impacts, and 61% characterize U.S. primary care as “crumbling.”
    • “Nearly 80% of respondents felt the current workforce is undersized to meet patient needs, and just 19% of clinicians report their practices are fully staffed.
    • “The results are emblematic of a “larger national crisis,” and policymakers must act to reinforce primary care, said Rebecca Etz, co-director of the Larry A. Green Center, in a statement. “ … It is not a matter of if, but when there will be another pandemic … If we don’t act soon, primary care won’t be there when it happens.”