Weekend update

Medical / Rx research

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.”

Thursday Miscellany

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

From Washington, DC —

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

From the public health front —

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

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

From the U.S. healthcare business front,

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

Weekend update

David Ermer–Congress, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Both Houses of Congress will be in session this week for floor voting and Committee business. Both Houses go on month-long State / District work breaks next week.
  • HR Dive reports
    • “The U.S. Senate on Thursday confirmed the nomination of Democrat Kalpana Kotagal to the U.S. Equal Employment Opportunity Commission. Her nomination as commissioner gives the workplace rights enforcement agency a Democratic majority. 
    • “The Senate voted 49-47 in favor of the Ohio native Thursday [July 13], after invoking cloture Wednesday. Kotagal will serve as the fifth commissioner of the agency with a term expiring July 1, 2027.” 

From the public health front,

  • Fierce Healthcare discusses an interesting United Healthcare population health program called Catalyst which operates in 28 states.
  • NPR Shots advises avoiding heat stroke and staying healthy when it’s hot outside.

From the medical research front,

  • The Wall Street Journal offers an essay about research underway to “get rid of menopause.”
    • “Imagine if women never reached menopause, that dreaded middle-age milestone—or could delay it, or decide when to have it.
    • “Women could remain fertile longer and would have more choice about when to start a family. They wouldn’t struggle with symptoms like hot flashes, mood swings and brain fog in the prime of their careers and family lives.
    • “Even more significantly, women might live longer and healthier lives. Though menopause—a full year without a menstrual cycle—is associated with the end of fertility, it also marks another profound but less recognized change. When the ovaries stop functioning and releasing important hormones, biological aging in women speeds up, increasing the risk of numerous health problems.
    • “Menopause is the single biggest accelerant of the diseases of aging for women across the board, whether it’s heart disease and stroke, autoimmune disorders, osteoporosis or cognitive decline,” says Piraye Yurttas Beim, founder and CEO of a biotech startup called Celmatix focused on improving ovarian health. “It’s the end of the function of a key organ in our body, and we should not normalize it any more than we would normalize tooth decay, osteoarthritis or cognitive decline.” * * *
    • “At Celmatix, the startup founded by Beim, researchers are seeking to develop what’s called an activator of the AMH hormone. A woman could take a drug to reduce the loss of follicles and eggs in her reserve and thus maintain optimal ovarian health and then go off the drug when she wants more eggs to be released to try to get pregnant.”

Friday Factoids

David Ermer–Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the U.S. healthcare business front –

  • Healthcare Dive tells us
    • “All eyes were on UnitedHealth’s medical costs when the health insurance giant reported second-quarter financial results on Friday, but rising outpatient utilization among seniors that spooked investors left the payer’s earnings largely unscathed.
    • “UnitedHealth’s medical loss ratio — the share of premiums spent on healthcare costs — was 83.2% in the quarter, higher than the 81.5% notched in the second quarter last year but lower than analyst expectations.
    • “In the second quarter, outpatient care activity among seniors was a few hundred basis points above our expectations,” UnitedHealth CFO John Rex said on a Friday morning call with investors. “Specific orthopedic and cardiac procedures have increased far above that level of variation.”
  • The Wall Street Journal adds
    • “Americans of all ages are seeking far more mental-health care for conditions including anxiety, depression and substance-use problems.
    • “UnitedHealth Group, parent of the nation’s biggest health insurer, said the percentage of people getting psychological visits and other services was up by double digits just since last year, and it believes the shift represents a long-term change. The company said people feel increasingly comfortable seeking help for behavioral-health issues, but it sees a continuing shortage of mental-health-care providers that is leading to problems with access.
    • “The rising use of behavioral-health care was one driver of higher healthcare costs flagged by the company during a call discussing its second-quarter financial results, which overall beat analysts’ expectations.”
  • BioPharma Dive reports
    • “Eli Lilly has agreed to acquire privately held biotechnology company Versanis in a deal that will add an experimental antibody to Lilly’s pipeline of medicines for obesity.
    • “The companies did not disclose a purchase price, but said in a statement Friday that upfront and milestone payments by Lilly to Versanis shareholders could be worth as much as $1.9 billion.
    • “Founded in 2021 by Aditum Bio, Versanis is built around a drug licensed from Novartis. The antibody, called bimagrumab, is designed to block cellular communication via two types of protein regulators and is being studied in people who are overweight or obese.”
  • Beckers Payer Issues points out that “Competition between Blue Cross Blue Shield companies is increasing after a 2022 antitrust settlement that struck down some agreements limiting competition between BCBS Association members, according to a July 13 report from Advisory Board.“
  • Per Reuters
    • “An influential U.S. drug pricing watchdog raised the price estimate of two experimental gene therapies from Vertex Pharmaceuticals (VRTX.O)/CRISPR Therapeutics and bluebird bio (BLUE.O) to as much as $2.05 mln, saying the new price can be cost effective to treat sickle cell disease.
    • “A price of up to $2.05 million a year, higher than the prior estimate in April of up to $1.9 million would meet some commonly used thresholds for cost effectiveness, the Institute for Clinical and Economic Review (ICER) said.”

From the SDOH front, Healthcare IT News notes “Without the need for deep learning and neural network models, researchers were able to use machine learning to extract social determinants of health information on housing challenges, financial stability and employment status from unstructured patient data in electronic health records, a new research report from Regenstrief Institute shows.”

From the plan design front —

  • HR Executive offers six ways to make a primary care strategy blossom. Check it out.
  • Fierce Healthcare lets us know
    • “The Center for Medicare and Medicaid Innovation (CMMI) has released a request for information to design a future episode-based payment model.
    • “The center is looking for feedback on questions related to care delivery, incentive structure alignment, clinical episodes, participants, health equity, quality measures and multipayer alignment, payment methodology and structure, and model overlap, according to the request.
    • “Episode-based payment models intend to address inefficiencies in traditional Medicare fee-for-service beneficiaries, where providers are paid for each item or service. This leads to “volume over value and fragment care,” according to the request.”

From the mental healthcare front,

  • KFF created a brief on the success to date of the 988 national suicide and crisis number.
    • Since its launch in July 2022, the 988 national suicide and crisis hotline has received about 4 million contacts, a 33 percent increase from the year before, according to a new KFF analysis of publicly available data through May 2023. The contacts include more than 2.6 million calls, over 740,000 chats, and more than 600,000 texts. The total number of contacts rises to almost 5 million when nearly 1 million additional contacts from the Veterans Crisis Line (VCL) are included, which were reported by the federal Substance Abuse and Mental Health Services Administration (SAMHSA), but aren’t yet publicly available.

Tuesday Tidbits

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

From Washington, DC —

  • The Senate Health Education Labor and Pensions Committee held its Superbugs hearing today.
  • STAT News informs us
    • “The witnesses largely seemed to organize behind the Pasteur Act in terms of how Congress should respond. This bipartisan legislation, which has been introduced in both the House and Senate, would encourage drug development by creating a subscription-style business model. In other words, the U.S. government would offer upfront payments to drugmakers in exchange for responsible stewardship policies and unlimited access to their antibiotics. A similar model has been successfully piloted in England over the past year, with the National Health Service planning a wider rollout to more pharmaceutical companies and to Northern Ireland, Scotland and Wales.
    • “The goal, as STAT has previously reported, is to enable pharmaceutical companies to recover their costs and make a profit — without predicating this on large volumes of antibiotics being prescribed. Helen Boucher, Dean of Tufts University School of Medicine, testified that this law would recognize these drugs “for their value, not for their use. It de-links incentives for overusing antibiotics.”
  • The Government Accountability Office released “a new report on the agency’s key findings and recommendations with an eye toward helping federal agencies be better prepared for future emergencies. GAO has regularly reported on the accountability and effectiveness of the federal government’s $4.7 trillion pandemic response since 2020.”
  • Per the White House,
    • “Today, in the continued efforts to fight the dangerous and deadly combination of xylazine mixed with fentanyl, the White House Office of National Drug Control Policy (ONDCP) released a National Response Plan to coordinate a whole-of-government response against this threat. Earlier this spring, ONDCP Director Dr. Gupta used an executive designation authority to designate fentanyl combined with xylazine as an emerging threat to the United States and proactively address this dangerous threat head-on.”
    • “Read the full National Response Plan to Fentanyl Combined with Xylazine HERE.
    • “Read about the Biden-⁠Harris Administration’s efforts to crack down on illicit fentanyl supply chains HERE.
    • “Read the Biden-Harris Administration’s National Drug Control Strategy HERE.”

From the public health front —

  • Federal News Network reports that twelve House of Representatives members are asking the Postal Service about steps being taken to protect letter carriers against the effects of high outdoor heat following the death of a letter carrier who passed away while delivering the mail in Texas.
    • “Eugene Gates Jr., a 66-year-old letter carrier in Texas, died June 20 while delivering mail during a heat wave with temperatures as high as 115 degrees. * * *
    • “The National Association of Letter Carriers, which represented Gates, said he collapsed and died in a customer’s yard while delivering mail. Gates, an Army veteran, served as a letter carrier for 36 years.
    • “Eugene was a dedicated letter carrier with a long and successful Postal Service career,” NALC National President Brian Renfroe said in a statement. “He will be greatly missed.”
  • STAT News tells us,
    • Weight loss medications from Novo Nordisk are being investigated by the European Medicines Agency after several reports of suicidal risks were referred to the watchdog, Bloomberg News reports. The regulator is looking at adverse events noted by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic. One additional case relating to thoughts of self-injury has been raised in connection with Saxenda. The agency is investigating the possible side effects in relation to patients who have used medicines containing the active ingredients semaglutide or liraglutide for weight loss. Novo’s hit weight loss drug Wegovy also contains semaglutide.
  • The Bloomberg article adds,
    • “Wegovy is currently available in the US with a warning and precaution for suicidal behavior and ideation on the label. While clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events, clinical trials of other weight management drugs have reported suicidal behavior and ideation, a spokesperson for the Food and Drug Administration said Monday.
    • “If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence,” the spokesperson said.”

From the medical research front,

  • According to the National Science Foundation —
    • “While it’s known that sleep plays a crucial role in strengthening memory, scientists are still decoding how the process plays out in the brain overnight.
    • “U.S. National Science Foundation-supported research led by scientists at UCLA and Tel Aviv University offers new evidence from inside the human brain supporting the dominant theory of how the brain consolidates memory during sleep.
    • “The researchers found that targeted deep brain stimulation during a critical time in the sleep cycle improved memory consolidation. The result came from a novel “closed loop” system that delivered electrical pulses in one brain region that activated the cerebral cortex, synchronized with brain activity recorded in another area, the hippocampus.
    • “The research, published in Nature Neuroscience, could offer new clues to how deep brain stimulation during sleep could help patients with memory disorders, said study co-author and physician-scientist Itzhak Fried of UCLA.”

From the Medicare front, NerdWallet identifies four Medicare policies that “should come with warning labels.” Number 1 is the Part B late enrollment penalty. The article encourages picking up Part B at the first opportunity, even if health expenses at the time are modest. Granted, this article is aimed at people, like the FEHBlog, who have Medicare without supplemental employer coverage. Nevertheless, federal employees should consider the advice too.

From the Rx coverage front

  • Beckers Hospital Review notes
    • “The FDA is allowing 10 more lots of cisplatin from a China-based pharmaceutical company to be imported to the U.S. to ease the ongoing cancer drug shortage, Bloomberg reported July 10. The additional lots are set to arrive next week. 
    • “In June, federal regulators cleared four lots of cisplatin from Qilu Pharmaceutical. While the version of the drug is unapproved in the U.S., it is similar to the approved version distributed across the country. 
    • “We will continue the importation until manufacturers can meet all needs,” Chanapa Tantibanchachai, an FDA spokesperson, told Bloomberg.
    • “Shortages of the essential cancer drug began in February and have caused some cancer centers to ration cisplatin and carboplatin, another cancer drug in shortage, treatments for patients. More recently, there have been signs of supplies stabilizing.” 
  • Fierce Healthcare discusses a recent HHS report on approaches to avoiding drug shortages.
  • Following up on its recent report about the lead-covered cabling problem in our country, the Wall Street Journal points out
    • “Supplies are running out for a key antidote for life-threatening lead poisoning.
    • “The drug, named dimercaprol, has been a go-to treatment for years for the worst cases of lead poisoning. But doctors have had to scrounge for dwindling doses since the medicine’s sole manufacturer for the U.S. declared bankruptcy in February.
    • “Now that some parts of the country don’t have any supplies left, doctors have been forced to turn to other, less preferred treatments.
    • “We’re using whatever we can get, knowing it will help, but not knowing if it’s doing as good of a job,” said Dr. Diane Calello, who directs the New Jersey Poison Control Center at Rutgers New Jersey Medical School.”

In U.S. healthcare business news

  • Beckers Payer Issues tells us
    • “The Cigna Group’s network of behavioral health providers grew by more than 30 percent in 2022, according to the company’s 2022 Environmental, Social, and Governance Report.
    • “The July report said the behavioral health network has grown to include more than 300,000 mental health and substance use providers, doubling its size over the past four years. The company also nearly doubled its virtual care network, which has grown to include more than 163,000 virtual behavioral health providers. In-network providers who support cultural and race-related counseling were increased.
    • “For behavioral health providers that specifically work with children, Cigna added 27,000 providers to its network in 2022, or an increase of 19 percent. It also increased the numbers of facilities treating children by 8 percent to 2,700 total.”
  • The Wall Street Journal delves into high-priced “clinics cater[ing] to a growing number of people obsessed with fighting aging.”
    • “Practitioners at Healthy Longevity Clinic, which has locations in Boca Raton, Fla., and Prague, build patients a personalized “longevity road map.” Those maps can include recommendations for diet, exercise, sleep and supplements. Patients are encouraged to stick with the program for at least a year, over which time their bill can run between $25,000 to more than $100,000, says Petr Sramek, the clinic’s chief executive.
    • “Longevity-clinic treatments aren’t often covered by health insurance. Some providers say they work with insurers to get coverage for medications or laboratory tests. 
    • “Many clinics use membership-based models in an effort to keep client loads low enough that providers can spend time with each patient. Others are fee-for-service or use a combination of the two.”