Thursday Miscellany

No Surprises Act

Thursday Miscellany

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

From Washington, DC

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

From the U.S. healthcare business front,

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

Friday Factoids

David Ermer–No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC

  • The AMA News says,
    • “The Centers for Medicare & Medicaid Services today released a FAQ explaining how it will handle the administrative fee for out-of-network providers and group health plans that initiate payment disputes under the No Surprises Act’s independent dispute resolution process on or after Aug. 3, when a federal judge vacated nationwide a six-fold increase in the fee. According to the FAQ, the fee for disputes initiated on or after Aug. 3 or unpaid before Aug. 3 will return to $50 per party until the Departments of Health and Human Services [HHS}, Labor, and the Treasury set a new fee amount.
    • “The judge also vacated nationwide the department’s restrictions on batching related claims in a single payment dispute. In response to the ruling, CMS has suspended the IDR process, including the ability to initiate new disputes. The agency said the departments intend to reopen the portal for new disputes soon and will notify interested parties at that time.”
  • Bear in mind that the independent dispute resolution entities will continue to charge $400 to $500 per party on top of the government’s fee.

From the Rx coverage front —

  • KFF Health News notes
    • Basics — “Leqembi [the recently approved Alzheimer’s Disease infused drug] is very effective at removing amyloid plaques (a protein that clumps between neurons) from people’s brains. But it doesn’t reverse cognitive decline or prevent future deterioration.”
    • Benefits — Research suggests that patients notice a “clinically meaningful” change in cognitive performance — a noticeable alteration in their ability to think, remember, and perform daily tasks — when scores rise at least 1 point on an 18-point scale used to measure Leqembi’s impact. But the change detected after 18 months for patients taking this medication was only 0.45%.
    • Side Effects — The drugmaker reported 17% of patients taking Leqembi experienced swelling in the brain and 13% had brain bleeds. Most of these side effects occurred during the first three months of treatment and were resolved without serious consequences four months later. In slightly more than 1 in 4 cases, there were also infusion-related side effects — chills, aches, nausea, vomiting, a spike or drop in blood pressure, and more. A little-discussed side effect is a reduction in brain volume associated with Leqembi and other anti-amyloid therapies. “We don’t know what this will mean to patients long term, and that’s concerning,” Alberto Espay, a professor of neurology at the University of Cincinnati College of Medicine said.
    • Not all patients will qualify. “I’m very carefully selecting the patients I think will be appropriate, focusing on people with mild cognitive symptoms who are otherwise healthy,” said Erik Musiek, an associate professor of neurology at the Washington University School of Medicine in St. Louis.
    • Costs could be considerable. Costs for Leqembi are difficult to calculate since Medicare officials haven’t announced what the government [Part B] will pay for services. But the University of Southern California estimates that a year’s worth of care, including the $26,500 cost of the medication, could total about $90,000, according to Schneider. A separate analysis by the Institute for Clinical and Economic Review suggests that all the medical services necessary to administer the drug, monitor patients, and undertake needed testing could total an average of $82,500 yearly on top of Leqembi’s direct cost.
  • Medscape informs us,
    • “A novel triple agonist to receptors for three nutrient-stimulated hormones led to weight loss as high as 24% among people with overweight or obesity but who did not have type 2 diabetes when used at the highest tested dose for 48 weeks. The results are from a phase 2 study of retatrutide that was published in The New England Journal of Medicine on August 9.
    • “This level of weight loss is “unprecedented” for a medication administered for 48 weeks, commented Mary-Elizabeth Patti, MD in an editorial that accompanied the report.
    • “The findings “offer further optimism…that effective pharmacologic management of obesity and related disorders is possible,” writes Patti, a principal investigator at the Joslin Diabetes Center in Boston.”
  • BioPharma Dive reports,
    • The Food and Drug Administration has conditionally approved a new medicine for multiple myeloma, offering patients with hard-to-treat forms of the blood cancer another therapy option.
    • “The medicine, which was developed by Johnson & Johnson and will be sold under the brand name Talvey, is what’s known as a bispecific antibody. A first of its kind, Talvey binds to both “CD3,” a protein found on T cells, and “GPRC5D,” a protein found on malignant blood plasma cells, bringing the two together so the immune system has a better shot at identifying and fighting cancer.
    • “The FDA based its decision on a clinical trial that enrolled multiple myeloma patients whose disease persisted after at least four other therapies. The trial found just under three-quarters of participants responded in some way to J&J’s drug, with roughly a third going into remission. Regulators have requested additional testing to confirm the benefits of Talvey and to keep it on the market.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Healthcare merger and acquisition activity hit a three-year low in the second quarter of this year, according to a report by accounting firm and consultancy KPMG. 
    • “The analysis tallied 245 deals in the second quarter of 2023, a decrease of 7% compared to the same period last year and a 41% decline from the second quarter in 2021. 
    • “Ongoing financial pressures — like potential interest rate hikes, political divisions and uncertainty about valuations of acquisition targets — could keep M&A low in the second half of the year. But some of those headwinds are expected to lighten up as sell-side valuations continue to contract and companies look to divest non-core assets, giving deal-making a boost during the first half of 2024, the report noted.”
  • Fierce Healthcare tells us
    • “While major payers issued warnings to investors ahead of second-quarter earnings about rising utilization rates, patients returning to deferred services did not prevent these companies from turning a profit.
    • “UnitedHealth Group led the way yet again in profitability for the second quarter as well as the first half of 2023, according to company earnings reports. The healthcare giant posted $5.5 billion in profit for the quarter and $11.1 billion through the first six months of the year.
    • “By comparison, the next-highest company for second-quarter profit was CVS Health at $1.9 billion. CVS also reported the second-highest profit for the first half of 2023 with $4 billion, according to the filings.
    • “UnitedHealth also tops the list for revenue in the second quarter and first sixth months of the year. The company reported $92.9 billion in second-quarter revenue and $184.8 billion in midyear revenue.”
  • The AHA News reports on its President Rick Pollack’s views on controlling medical consumer debt. Of course, Mr. Pollack does not mention lowering healthcare prices which is a straight line to debt reduction. Rather, he focuses on adding administrative burdens to health insurers and plans and reducing consumer choice of health plans.

Monday Roundup

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

From Washington, DC —

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

From the public health front —

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

From the No Surprises Act front

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

In other U.S. healthcare business news —

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

Friday Factoids

David Ermer–COVID-19, FDA, HSA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The Food and Drug Administration announced today
    • “approv[ing Sage Therapeutic’s] Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a healthcare provider in certain healthcare facilities.
  • STAT News informs us
    • “A new White House task force on drug shortages held a rare in-person meeting last Friday with representatives from hospitals, drugmakers, pharmacies, and others in the drug supply chain to brainstorm policies for stemming shortages of cancer drugs.
    • “The meeting at the Eisenhower Executive Office Building focused on immediate steps that could help alleviate shortages, such as allowing temporary importation of drugs from other countries, according to an attendee and three others with knowledge of the discussion. It also touched on purchasing issues.”
  • HR Dive relates
    • “The National Labor Relations Board on Wednesday reversed its Trump-era stance that allowed employers to maintain certain handbook policies, such as those mandating a respectful workplace (Stericycle, Inc. and Teamsters Local 628).
    • “The shift means all policies that restrict employee speech and actions must be reviewed — “and very likely rewritten,” according to Peter Spanos, a partner at law firm Taylor English.”

From the public health front —

  • The Leapfrog Group now offers ratings on maternity care services.
  • Health Day relates,
    • “A micronutrient in human breast milk may provide significant benefit to developing newborn brains, according to new research that sheds light on the link between nutrition and brain health.
    • “Scientists looked at this sugar molecule in rodents and in human neurons. They said the micronutrient, called myo-inositol, may lead to improved infant formulas.
    • “The current research does indicate that for circumstances where breastfeeding is not possible, it may be beneficial to increase the levels of myo-inositol in infant formula,” said study co-author Thomas Biederer.
    • “Myo-inositol may also play a part in the aging brain, according to the research conducted at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) at Tufts University in Boston.”
  • STAT News lets us know,
    • “Early-stage cancer diagnoses decreased by nearly 20% in the first year of the Covid-19 pandemic. A new study published in Lancet Oncology emphasizes how, because of disruptions in care, patients were more likely to get diagnosed with deadly metastatic disease — across nearly all cancer types.
    • “This study is the most comprehensive analysis of cancer diagnoses during the pandemic, using a nationwide registry that captures over 70% of all cancers in the United States. The starkest decline was observed after the initial shutdowns, with the regular 70,000 monthly cancer diagnoses (captured by the study’s inclusion criteria) being cut in half in April 2020.”
  • KFF News offers polling data on consumer interest in the new injectable weight loss drugs and their attitudes toward pharmaceutical companies and “A Look at the Latest Suicide Data and Change Over the Last Decade” in our country.

From the U.S. healthcare business front —

  • The Kaiser Foundation announced
    • “For the quarter ending June 30, 2023, Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their respective subsidiaries (KFHP/H) reported operating revenues of $25.2 billion and operating expenses of $24.4 billion compared to operating revenues of $23.5 billion and operating expenses of $23.4 billion in the same period of the prior year. Operating income was $741 million for the second quarter of the year compared to operating income of $89 million in the second quarter of 2022.
    • “Like all health systems, Kaiser Permanente is experiencing ongoing cost headwinds and volatility driven by inflation, labor shortages, and the lingering effects of the pandemic on access to care and service.
    • “Due to favorable financial market conditions, Kaiser Permanente benefited from strong investment income with other income (net of other expenses) of $1.3 billion for the second quarter, compared to a $1.4 billion loss in the second quarter of 2022. For the second quarter, net income was $2.1 billion compared to a net loss of $1.3 billion in the same period of 2022.”
  • Healthcare Dive points out
    • “Patrick Conway is stepping up as CEO of UnitedHealth pharmacy benefit manager OptumRx effective immediately, according to a Thursday post on the executive’s LinkedIn, as part of a leadership shakeup at the healthcare giant.
    • “Conway is replacing Heather Cianfrocco, who is pivoting to president of Optum. Cianfrocco will lead the division’s pharmacy and care delivery capabilities, per UnitedHealth’s website.
    • “Cianfrocco replaces John Prince as Optum president. Prince has departed the company to serve as a senior advisor to private equity firm TPG, according to his LinkedIn.”
  • EBRI announced
    • “A new research report published today by the Employee Benefit Research Institute (EBRI) found that cost-sharing shifted from deductibles to copayments and coinsurance among enrollees in HSA-eligible health plans for a number of services impacted by IRS Notice 2019-45. The report, “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Employee Choice of Health Plan and Cost Sharing,” analyzed claims data to quantify the effect of expanding pre-deductible coverage on enrollee choice of health plan and cost-sharing.
    • “In response to IRS Notice 2019-45, three-quarters of large employers and health plans offering HSA-eligible health plans expanded pre-deductible coverage for medications and services that prevent the exacerbation of chronic conditions. As a result, it is not surprising that when examining medical claims, cost-sharing shifted from deductibles to copayments and coinsurance for enrollees in HSA-eligible health plans,” explained Paul Fronstin, Ph.D., director, Health Benefits Research, EBRI. “The percentage of cost sharing paid through deductibles fell for antidepressants, insulin and other glucose-lowering agents, statins, beta blockers and inhaled corticosteroids.”
  • Health Payer Intelligence updates us on the status of provider challenges to the No Surprises Act’s arbitration rules.
    • “The legal challenges highlight the difficulties of prioritizing affordable healthcare for consumers. With payers and providers holding opposing views, federal policymakers must reach a conclusion that benefits both sides and improves costs for consumers.
    • “If federal agencies cannot establish reasonable guidelines for the IDR process, Americans may face an inflationary federal IDR process that results in higher premiums and healthcare costs, according to Georgetown University’s O’Neill Institute.
    • “There is a strong urgency to determine concrete guidelines, given the high amount of disputes that payers and providers have submitted through September 2022, a CMS report indicated.”
  • Behavioral Health Business reports
    • “The Cigna Group (NYSE: CI) has seen a historic but expected rise in behavioral health benefits utilization in recent years. 
    • “These insights, presented by the health care insurance and service conglomerate’s executives, echo others made by UnitedHealth Group (NYSE: UNH) executives on their second-quarter earnings call. 
    • “As it relates to what we’re seeing in terms of trends in terms of utilization, behavioral health has certainly been growing at a strong clip, not just this year, but for the past few years,” Brian Evanko, The Cigna Group’s CFO said Thursday on the company’s second-quarter earnings call. “Part of that is by design as we engage with our customers. And over time, that’s a good thing because the more utilization we see in behavioral health services, [the more] it helps to defray core medical costs.”

Happy Flag Day!

David Ermer–ACA, CMS, Congress, FDA, No Surprises Act, Rx coverage, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Washington DC —

  • The Senate Finance Committee announced
    • “Senate Finance Chairman Ron Wyden (D-Ore.), Senate Finance Ranking Member Mike Crapo (R-Idaho) alongside U.S. Senators Bob Menendez (D-N.J.), Marsha Blackburn (R-Tenn.), Jon Tester (D-Mont.), Roger Marshall (R-Kan.), today introduced the Patients Before Middlemen (PBM) Act to delink the compensation of pharmacy benefit managers (PBMs) from drug price and utilization in order to better align incentives that will help lower prescription drugs costs for Medicare Part D beneficiaries.”
  • Fierce Healthcare informs us
    • “While national health spending growth slowed in 2022, that trend isn’t likely to stick around.
    • “Experts at the Centers for Medicare & Medicaid Services’ Office of the Actuary predict that health spending growth will outstrip growth in the economy over the next decade, according to a study published in Health Affairs. Between 2022 and 2031, the actuaries predict spending will increase by 5.4% on average each year, faster than the estimated annual gross domestic product growth of 4.6%.”
  • As the French say, Plus ça change, plus c’est la même chose (literally the more it changes, the more it’s the same thing”.
  • CMS made its No Surprises Act website more consumer friendly.

In conference news, MedPage Today fills us in on the American Medical Association conference and Smartbrief does the same for the AHIP conference.

From the Rx coverage front —

  • Beckers Hospital Review tells us,
    • “Mark Cuban Cost Plus Drug Co. considered selling insulin but found the price doubled with shipping costs, CEO and co-founder Alex Oshmyansky, MD, PhD, said June 13 at the AHIP conference. * * *
    • “We were working on bringing in an insulin product to the market for quite some time,” he said at the conference. “We did actually bring one to the market, we did it as sort of a closed beta pilot to see what consumer response would be. But ultimately, direct to consumer mail-order it was $35 for a month’s supply but $65 for the shipping and handling. It didn’t quite make sense within our model. We almost viewed it as a solved problem from the consumer perspective at this point. You know, almost everyone has access to $35 insulin in one form or another now.”
  • Reuters reports,
    • “Pfizer (PFE.N) has warned that a drug used to treat syphilis and other bacterial infections in children could run out by the end of June because it has had to prioritize versions made for adults due to a spike in syphilis infections in that population.
    • “Supply of the pediatric version of the drug, Bicillin L-A, is expected to be exhausted by the end of this quarter, the company said in a letter to the U.S. health regulator dated Monday. Pfizer said in an email on Tuesday that the pediatric formulations of the antibiotic are not widely used.”
  • Medscape informs us
    • The US Food and Drug Administration (FDA) has expanded the indication for linaclotide (Linzess) to children as young as age six years with functional constipation, making it the first approved treatment for pediatric functional constipation.
    • The recommended dosage in pediatric patients is 72 mcg orally once daily.
    • Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
    • There is no known underlying organic cause, and there are typically multiple contributing factors, the FDA notes in a statement announcing the approval.

From the U.S. healthcare business front —

  • Healthcare Dive notes,
    • “Pent-up demand for delayed healthcare during the COVID-19 pandemic is pressuring medical costs for health insurers that had a financial windfall during the pandemic amid low utilization.
    • “UnitedHealth, the parent company of the largest private payer in the U.S., expects its medical loss ratio — the share of premiums spent on member’s healthcare costs — to be higher than previously expected in the second quarter of 2023, due to a surge in outpatient care utilization among seniors,” CFO John Rex said Tuesday during Goldman Sachs’ investor conference.”
  • Fierce Healthcare relates,
    • “Cerner brought in $1.5 billion in revenue in the latest quarter, boosting strong growth for enterprise software giant Oracle. The health IT company also generated $5.9 billion in revenue for Oracle’s 2023 fiscal year, which ended May 31.
    • “Oracle’s revenue reached an all-time high of $50 billion last year, driven by growing demand for its cloud offerings from companies deploying AI.”

In litigation news —

  • Health Payer Intelligence points out,
    • On June 13, “A federal appeals court approved an agreement between parties in Braidwood Management v Becerra, preserving the mandate requiring health plans to cover preventive care services based on recommendations from the US Preventive Services Task Force (USPSTF). * * *
    • “While the federal government works to appeal Judge O’Connor’s ruling, it cannot penalize Braidwood Management for refusing to cover USPSTF-recommended preventive care services. Additionally, if the court upholds the mandate in the appeal, the Biden administration cannot retroactively penalize the plaintiff.”

Tuesday’s Tidbits

David Ermer–Congress, No Surprises Act, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

Fierce Healthcare reports

  • “Sens. Bernie Sanders, I-Vermont, and Bill Cassidy, R-Louisiana, reached a deal on new legislation that aims to increase access to generic drugs and impose transparency measures on pharmacy middlemen.
  • “The two senators, the new leaders of the powerful Senate Committee on Health, Education, Labor and Pensions (HELP), said the legislative package will “reform pharmacy benefit managers and expand the availability of low-cost generic drugs.”
  • “The committee will hold a hearing on May 2 to consider the legislative package, which includes four bills.”

Govexec adds

  • “Sen. Tammy Duckworth of Illinois, Reps. Gerry Connolly of Virginia, Eleanor Holmes Norton of Washington, D.C., and Debbie Wasserman Schultz of Florida, all Democrats, and Rep. Nancy Mace of South Carolina, a Republican, [introduced] the Family Building FEHB Fairness Act on Tuesday, marking National Infertility Awareness Week.
  • “Duckworth said the proposed legislation would cover other IVF-related costs and expand coverage to all the different forms of assisted reproductive technology. The most common type of assisted reproductive technology by far is IVF, but there is also gamete intrafallopian transfer, zygote intrafallopian transfer and frozen embryo transfer.” 

The FEHBlog expects that fertility coverage advocates will be pleased with FEHB carrier initiatives for 2025.

From the social determinants of health front —

  • Patient Engagement HIT informs us,
    • The different social determinants of health have different impacts on healthcare quality, utilization, and outcomes, with new Humana data showing that some SDOH are more closely related to poor care quality while others are more closely related to high healthcare utilization.
    • For other SDOH, like social isolation and limited access to transportation, patients experience both poor care quality and high acute care utilization, the JAMA Network Open report showed. * * *
    • This latest study looked at which SDOH have the biggest impact on health and well-being, as measured by care quality and acute care utilization, to better determine effective SDOH interventions going forward.

From the public health front

  • The All of Us Research Program celebrates National DNA Day!
  • Medscape reminds us that unexpected weight loss can be a health warning.
    • “Our study emphasizes the importance of weight loss even in relatively healthy individuals who are free from evident cardiovascular disease (CVD), dementia, physical disability, or life-limiting chronic illness,” first author Monira Hussain, MBBS, MPH, PhD, told Medscape Medical News.
    • “Clinicians should be aware that even minor weight loss of 5% or more in older adults without life-limiting illnesses can increase mortality risk,” Hussain said. “Regular monitoring of weight changes can help early identification of associated risks.”
    • The study was published online April 10 in JAMA Network Open.
  • STAT News tells us, “Consumers turning to melatonin gummies to get some help falling asleep might be getting a lot more help than they bargained for, according to a new study published Tuesday in the Journal of the American Medical Association.”
    • “However, one dietary supplement lobbying group argued that variability in strength of the gummies studied is to be expected, and is often purposefully done by manufacturers to ensure they do not degrade overtime and thereby run afoul of the FDA’s rules. Dietary supplements are required to demonstrate they contain 100% of the listed ingredient until their expiration date, and thus manufacturers will “put an overage in to start to be sure that six months from now that when that consumer buys the product, they’re still getting 100% of what’s on the label,” according to Steve Mister, the CEO of the Council for Responsible Nutrition.
    • “Mister conceded that he did share concerns about two of the products studied — one which included no melatonin and another that included more than 300% of the advertised amount. He maintained, however, that “there is … absolutely nothing in this study that should alarm consumers.”

From the U.S. healthcare business front

  • Fierce Healthcare relates, Health insurer “Centene Corporation posted $1.1 billion in profit for the first quarter of 2023, up from $849 million in earnings in the prior year quarter. The company’s revenue was also up year-over-year, reaching $38.9 billion compared to $37.2 billion in the first quarter of 2022. The numbers fall short of Wall Street analysts’ expectations on profit but exceed their predictions on revenue, according to analysts at Zacks Investment Research.”
  • Per Healthcare Dive,
    • “Tenet Healthcare, one of the largest for-profit hospital operators in the U.S., raised its forecast for full-year profit after posting growth in case volumes that boosted revenue and net income in the first quarter.
    • “The company said on Tuesday that quarterly profit climbed 2.9% from a year earlier to $143 million, beating an earlier forecast that net income would range between $90 million and $125 million in the period..
    • “The earnings results also beat Wall Street revenue estimates, according to SVB Securities analysts. Tenet logged $5 billion in revenue, a 5.8% increase compared to the first quarter of 2022.”
  • Per MedTech Dive,
    • “Labcorp on Tuesday reported a 10% increase in its base business revenue in the first quarter and said the proposed spinoff of its clinical development unit would be completed as expected at mid-year.
    • “The company’s base business benefited from an agreement to manage laboratories for the Ascension health system, Labcorp said. That relationship contributed about 4% of Labcorp’s organic growth in the first quarter, CEO Adam Schechter said on the company’s earnings call.
    • “Labcorp is now managing laboratories in nearly 100 Ascension hospitals, Schechter said. The partnership, established early last year, covers Ascension hospital-based labs in 10 states.”

Axios updates us with developments from the No Surprises Act front.

“What we’re watching: Lawmakers in the House and Senate said they’re planning to conduct oversight of the law, with Republicans focusing on how the Biden administration is implementing it.

  • “Senate health committee ranking member Bill Cassidy (R-La.) noted that “the courts continue to toss out the way that the administration has implemented [the law]. So, oversight hearings, we’re going to have some discussions in the HELP Committee. I think that’s all appropriate.”
  • “A federal judge in Texas has ruled in favor of providers in two of the lawsuits.
  • “Florida Republican Rep. Vern Buchanan, chair of the Ways and Means Health Subcommittee, said the committee would hold a hearing on the topic in June. A GOP committee aide said “the hearing schedule was fluid,” but given the bipartisan interest, “this is a strong potential topic” for a hearing.

“Yes, but: When asked, lawmakers weren’t sure what Congress might be able to do to fix providers’ issues, though some are open to new legislation.”

The FEHBlog is on record favoring that the Administration’s approach to implementing the law in a way that controls healthcare spending.

Midweek Update

David Ermer–Congress, Electronic health records, HSA, No Surprises Act, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC —

Roll Call brings us up to date on the debt ceiling issue. “House Republicans unveiled legislation Wednesday to pair their favored spending cuts and energy and regulatory policies with a debt limit increase lasting through early next year.” “Measure viewed as a ‘conversation starter’ with government cash crunch seen as early as June.”

The Wall Street Journal informs us that the U.S. Supreme Court extended its stay of an injunction restricting sales of an abortion pill from midnight tonight to midnight Friday.

  • “The justices have three primary options. They could grant the emergency requests and leave mifepristone on the market indefinitely during litigation, which could preserve the status quo for many months. They could leave the pill in place temporarily and agree to review the case in full, even though lower courts aren’t done reviewing it. Or they could deny the emergency appeals outright.” 

As anticipated, Health Affairs Forefront has posted here and here helpful articles explaining the final 2024 Notice of Benefit and Payment Parameters released earlier this week.

From the U.S. healthcare business front —

  • Beckers Payer Issues tells us,
    • Elevance Health posted double-digit revenue growth and beat investor expectations in the first quarter of 2023, according to the company’s earnings report published April 19.
    • “Elevance Health is off to a strong start in 2023, driven by our continued focus on whole health and advancing health beyond healthcare,” President and CEO Gail Boudreaux said.
  • Beckers Hospital Review adds,
    • Mark Cuban is creating an independent pharmacy network to “serve patients more widely” after pitching the idea to local pharmacy owners in February. 
    • Mark Cuban Cost Plus Drug Co. has operated as a mail-order, online pharmacy since January 2022, but with its latest endeavor, the business is looking to expand access to its portfolio of more than 1,000 prescription drugs.
    • The collaboration between independent pharmacies and Cost Plus Drugs includes a “Team Cuban Card,” which acts like an insurance card at pharmacy checkouts. 
    • Independent pharmacists interested in partnering with Cost Plus Drugs were asked to complete an interest form with the company detailing the type of pharmacy they run and how patients access the services offered. So far, Cost Plus Drugs has 36 affiliate locations, with five in Florida, seven in Indiana, six in New Jersey and 18 in Texas. The company said it will add new sites every month.
    • This is part of a larger movement to prevent more local pharmacy closures, Mr. Cuban told Becker’s. 
  • STAT News reports
    • Because Johnson & Johnson is the largest healthcare company in the world, its financial fortunes tend to be a bellwether for the industry at large. And parsing J&J’s positive results from the last quarter, released yesterday, analysts see hope that the pharmaceutical business is in good shape despite a difficult macroeconomic environment.

From the HIMSS conference —

  • Med City News shares a conference presentation by “Glen Tullman — CEO of care navigation company Transcarent, as well as former CEO of Allscripts and Livongo. Mr. Tullman discussed what he thinks the future of healthcare will look like during the HIMSS conference in Chicago. He laid out five predictions, including an increased focus on consumer expectations and more investment in AI.”
  • Fierce Healthcare points out
    • Companies like Best Buy and VillageMD are disrupting the traditional healthcare industry by bringing a more consumer-centric approach to providing medical services.
    • During a keynote address Wednesday morning at HIMSS23, executives at these so-called “disrupters” shared their vision for the future of care delivery.
  • You will find HIMSS links to its sessions here and here.

From the Rx and medical test coverage front —

  • The Institute for Clinical and Economic Research issued a white paper
    • Evaluating Best Practices and Potential Reforms for White Bagging, Brown Bagging, and Site of Service Policies that Seek to Address High Markup in Drug Prices
      • — White bagging, brown bagging, and site of service policies developed by payers can reduce significant markup costs for clinician-administered drugs but have sparked concerns and legislative action related to their impact on patients and providers —
      • — White paper evaluating best practices and potential policy reforms was informed by input from a diverse set of hospitals, provider groups, and payers.
  • Medscape delves into the debate over the optimal time period for using weight loss drugs.
  • The Wall Street Journal examines new blood tests that offer early detection of cancers and Alzheimer’s Disease.
    • “Questions include who should be getting them, and what patients should do about positive results.”

From the miscellany front —

  • Fierce Healthcare informs us, as the FEHBlog expected,
    • The federal No Surprises Act “appears” to be effectively protecting patients from the most frequent sources of unexpected medical bills, though several coverage gaps such as those relating to ground ambulance services are still leaving some patients with hefty bills, according to a new qualitative report.
    • To get a read on the consumer protection legislation after a full year of implementation, researchers from the Urban Institute and Georgetown University’s Center on Health Insurance Reforms, with backing from the Robert Wood Johnson Foundation, interviewed 32 regulators and stakeholders representing consumers, payers, hospitals, billing companies and other relevant industry subsectors.
    • These informants “largely agreed that consumers are being well protected from surprise balance bills covered under the law,” researchers wrote in the report.
  • Health Payer Intelligence notes
    • Many consumers would be interested in a type of account that was like a health savings account (HSA) in its construction but able to be attached to plans other than high deductible health plans (HDHPs), a survey from Employee Benefit Research Institute (EBRI) stated.
    • “We decided to test enrollee interest in a new type of health account similar to an HSA. Like an HSA, the new health account could be funded by both workers and employers, could be invested in the stock market, and would be portable from job to job. Earnings would grow tax free, and contributions would be capped,” the EBRI researchers explained.
    • “Unlike an HSA, this new health account would not have to be paired with a high-deductible health plan; it could be paired with any health plan.”
  • “AHIP released the latest version of its comprehensive, biennial report, Health Coverage: State-to-State 2023, which analyzes health coverage and health insurance provider industry employment for all 50 states and the District of Columbia.”

Late Week Miscellany

David Ermer–ACA, CDC, COVID-19, FDA, No Surprises Act, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Dear FEHBlog readers — The FEHBlog wrote a quick blog post for Thursday but overlooked hitting the publish button, so here are the two items from Thursday and the remainder from Friday.

Wednesday afternoon, the Affordable Care Act regulators issued ACA FAQ 59 about the Braidwood Management decision. The FAQs expressly endorsed OPM’s informal administration action last Friday using FEHB Act Section 8902(d) to endorse the U.S. Preventive Services Task Force recommendations that the decision rejected because they had no federal government endorsement. The FEHBlog wonders why HHS hasn’t pulled this page out of OPM’s playbook.

Wednesday night, the U.S. Court of Appeals for the Fifth Circuit (2-1 decision) stayed a portion of the abortion pill injunction on statute of limitations grounds in a 42-page opinion. The Fifth Circuit opinion allows the abortion pill to stay on the market with reinstated in-person medical visit prerequisites and without delivery by mail. The Attorney General has stated that he will ask the Supreme Court to weigh in. Axios reports that the Supreme Court would decide quickly.

Axios was correct because the Wall Street Journal reported that today

  • The Supreme Court temporarily blocked lower court orders that would have limited access to the abortion drug mifepristone beginning Saturday, preserving the pill’s availability while the justices weigh the Biden administration’s emergency request to leave current Food and Drug Administration approvals in place during a continuing legal battle with antiabortion groups.
  • In a pair of orders Friday, Justice Samuel Alito, who oversees emergency matters for the lower courts that limited or suspended approval of the widely used abortion pill, gave the antiabortion groups until noon Tuesday to file briefs in response to appeals by the FDA and Danco Laboratories LLC, which makes the branded version Mifeprex.
  • The temporary orders expire at 11:59 p.m. Wednesday, suggesting a high court decision on whether and to what extent mifepristone will remain available during litigation may come by then.

In other judicial news, the American Hospital Association informs us

  • The U.S. Supreme Court today unanimously reversed a 9th Circuit decision that impliedly stripped federal district courts of jurisdiction over constitutional challenges to the Federal Trade Commission structure, procedures and existence. Ruling in the FTC case and another case involving the Securities and Exchange Commission, the Supreme Court said, “The statutory review schemes set out in the Securities Exchange Act and Federal Trade Commission Act do not displace a district court’s federal-question jurisdiction over claims challenging as unconstitutional the structure or existence of the SEC or FTC.”
  • As a result of this decision, parties may bring claims in federal court alleging that “the structure, or even existence, of an agency violates the Constitution” without having to first go through costly and time-consuming administrative proceedings before the SEC or FTC.

Turning now to the federal employment front –

  • Govexec tells us
    • Office of Management and Budget guidance released Thursday tasks agencies with developing a new system to monitor their “organizational health and organizational performance” on an ongoing basis. With the new system comes an expectation that federal agencies will rely less on telework and remote work, although that must be balanced with the need to compete for talent with private sector employers who continue to offer similar workplace flexibilities, wrote OMB Deputy Director for Management Jason Miller in a blog post accompanying the memo.
  • Federal News Network reports OPM’s implementation of the Postal Service Health Benefits Program.

From the public health front

  • The Centers for Disease Control begins to bring down the curtain on its now bi-weekly review of its Covid statistics and updates us on the bird flu situation.
  • The Food and Drug Administration announced granting emergency use authorization to an improved Covid test.
  • The Robert Wood Johnson Foundation offers various perspectives on achieving joyful, healthy births for all, a worthy goal.
  • Medscape identifies troubling trends in colorectal cancer data recently released by the American Cancer Society.

From the regulatory front —

  • Mercer Consulting offers advice on the recent instructions concerning RxDC reporting for the 2022 reference year due June 1.
  • Healthcare Finance tells us
    • The Office of Civil Rights is providing a 90-day transition period for healthcare providers to come into compliance with the HIPAA Rules regarding telehealth, according to the Department of Health and Human Services OCR. 
    • The transition period will be in effect beginning on May 12 and will expire at 11:59 p.m. on August 9.
    • OCR said it would continue to exercise its enforcement discretion and not impose penalties on covered providers for noncompliance during the 90- day transition period. 
    • During the public health emergency, providers did not have to be licensed in the state where the patient was located. They were allowed to treat patients in other states. 
    • Also, under the PHE, non-HIPAA-compliant platforms were allowed as long as they were not public facing.
    • Both of these flexibilities are coming to an end with the PHE on May 11, with providers now getting a 90-day grace period.
    • Other telehealth provisions expire at the end of 2023 and 2024

From the Rx coverage front —

  • Fierce Healthcare informs us that Cigna’s Express Scripts unveiled two new programs on Thursday, Copay Assurance and ClearCare Rx, which reminds the FEHBlog of OPM’s transparent pharmacy pricing program.
  • The Institute for Clinical and Economic Research (ICER) published an
    • Evidence Report on Treatments for Non-Alcoholic Steatohepatitis [liver inflammation]
      • — Evidence suggests that both resmetirom and obeticholic acid improve liver histology without evidence yet demonstrating improved long-term outcomes; obeticholic acid has more concerning side effects —
      • — Current evidence suggests that resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year, while obeticholic acid would achieve these thresholds if priced between $32,800-$40,700 per year —
      • — At the April 28 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatments’ comparative clinical effectiveness, other potential benefits, and long-term value for money —

From the U.S. healthcare business front

  • Beckers Payer Issues reports, “UnitedHealth Group posted revenues of $91.9 billion in the first quarter of 2023, up 15 percent from $80.1 billion over the same period last year, according to the company’s earnings report released April 14.”
  • Beckers Hospital Review ranks 29 physician specialties by annual compensation.

Monday Roundup

David Ermer–Congress, Government Contracting, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Politico points out that

The Senate Finance Committee will hold a hearing Thursday on the impact PBMs — the pharmaceutical middlemen that negotiate drug discounts with drugmakers and design prescription drug benefits for health plans — have on the health system.

The House Energy and Commerce Health Subcommittee is also expected to look into how much value PBMs add as part of a broader discussion about fairness in the healthcare market, according to a memo shared with [Politico].

In related news, CMS “released several Prescription Drug Data Collection (RxDC) resources on the Registration for Technical Assistance Portal (REGTAP). To view the documents, click on the link next to each document title. You may already have the links in your bookmarks.”

This guidance applies to the 2022 RxDC report that health plans must submit by June 1, 2022. Health plans submitted the first RxDc report for the 2021 reporting year last January. The No Surprises Act calls for a standard June 1 submission date for the RxDC report for the previous reporting year.

CMS also announced that the public has sixty days (to May 26) to comment on the revised Reporting Instructions.

The FEHBlog recently discovered this CMS REGTAP portal. As you can see, this portal is not just for Medicare and Medicaid. The portal includes a link to get an email announcement when REGTAP changes. REGTAPs emails are handy and not overwhelming.

From the Rx coverage front —

STAT News adds an interesting perspective on last week’s Senate hearing on Moderna Covid vaccine pricing

What, [Chairman Bernie] Sanders asked [Moderna CEO Stephane Bancel], if instead of purchasing medicines after they had been developed at high prices, the government instead paid for companies’ research, enough to ensure they make a reasonable profit? Then, Sanders said, the medicines could be made available inexpensively to anyone who needed them.

Bancel, clearly baffled by what sounded a lot like the government seizing the means of pharmaceutical production, simply said it was impossible to evaluate such a plan without details.

As much as the plan sounds like socialism, in a world where substantial quantities of new medicines are purchased by government programs, Sanders’ idea is pretty close to the way defense companies work: The government pays them substantial amounts of money to develop jet fighters, satellites, and aircraft carriers. This system is certainly not cheap, but it represents an alternative to the way medicines are developed. * * *

Whether this is a good idea or not, it probably won’t happen. Because not only is Congress unlikely to fund a $200 billion-a-year effort to replace industry research on new medicines, it won’t fund a $20 billion effort to get the government in the game, either.

Beckers Hospital Review informs us

Walgreens and Village Medical have launched a new pilot program that helps patients manage new medications prescribed during their hospital stay. 

The program, launched as a pilot in Florida and Texas, helps Walgreens and Village Medical patients manage their new prescriptions and existing ones after they are discharged from a hospital, according to a March 23 release from Walgreens. 

The aim of the program is to improve patient outcomes and decrease costs associated with hospital readmissions.

From the substance use disorder front, STAT News reports

Public health workers will soon have a new tool at their disposal to thwart a spreading danger to users of illicit drugs: xylazine test strips.

The new testing kits will allow health departments, grassroots harm-reduction groups, and individual drug users to test substances for the presence of xylazine, a sedative often referred to as “tranq.”

The toxin is increasingly common in the U.S. illicit-drug supply — especially in the Philadelphia area, but increasingly in other cities, too. Xylazine, which is typically used as a sedative in veterinary settings, can cause people to stop breathing, and also often causes severe skin wounds when injected.

While helpful for public health workers, will drug users take the time to do both tests when the two potentially fatal drugs usually are combined? FEHBlog expects that a fentanyl and xylazine test strip will be on the market soon.

From the U.S. healthcare business front —

  • Hospitals strongly oppose MEDPAC’s recommendation that Medicare Part A make a low reimbursement increase for the new federal government fiscal year, while some healthcare economists support MEDPAC’s proposal.
  • Healthcare Dive tells us
    • “CVS plans to close its acquisition of home healthcare provider Signify Health on or around Wednesday, subject to certain conditions, the company announced Monday.
    • “CVS agreed to acquire Signify for $30.50 a share in cash in September in a transaction worth roughly $8 billion.
    • “That deal will close this week as long as CVS and Signify can meet or waive the remaining conditions in their merger agreement, according to CVS. A CVS spokesperson declined to share details on the remaining conditions.
  • Beckers Hospital Review notes that another well know CEO has ripped a page out of the Mark Cuban playbook.
    • “Love.Life, a health and wellness company co-founded and run by former Whole Foods CEO John Mackey, acquired Plant Based TeleHealth, a telehealth service focusing on the prevention and reversal of chronic conditions.
    • “The company will rebrand as Love.Life Telehealth. The company offers virtual visits to patients with chronic conditions and promotes healthy behaviors, according to a March 21 Love.Life news release.
    • “Patients can sign up for half-hour appointments for $175 or hourlong appointments for $350.”
    • “Love.Life is about making lasting health and vitality achievable, and acquiring Plant Based TeleHealth accelerates our ability to help more people without geographic limitations,” Mr. Mackey said. “Appointments are available now, and we’re excited to offer telehealth services as part of the comprehensive medical offering available in our physical locations, which will begin opening in 2024.”

Friday Factoids

David Ermer–COVID vaccine mandate, COVID-19, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the public health report, here are the CDC’s Covid Data Tracker and the CDC’s FluView this week. Covid cases and hospitalizations continue to trend down, while Covid deaths leveled off after reaching a pandemic low last week. FluView notes, “CDC estimates that, so far this season [which runs from October through April], there have been at least 26 million illnesses, 290,000 hospitalizations, and 18,000 deaths from flu.”

The American Hospital Association adds

The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations. The Biden Administration plans to end the COVID-19 PHE declaration on May 11. The COVID-19 EUA declaration for COVID-19 diagnostics, personal protective equipment, other medical devices, and drug and biological products will remain in effect until there is no longer a “significant potential” for a COVID-19 PHE or the authorized devices or products have been approved.

From the Covid vaccine mandate front, per Fierce Healthcare, the U.S. Court of Appeals for the 5th Circuit held en banc (all of the active judges not a three judge panel), held that Feds for Medical Freedom have standing to challenge the Covid vaccine mandate on federal employees. This means that the nationwide preliminary injunction that has blocked enforcement of the mandate remains in force.

As you may recall, earlier this week, a panel of the U.S. Court of Appeals for the D.C. Circuit reached the opposite result. Such a split in decisions from different circuits is grounds for the Supreme Court to review the case, if requested (cert petition). It remains to be seen whether the end of the public health emergency also will bring down the curtain on the various Covid vaccine mandate challenges.

In other litigation news, Beckers Hospital Reviews brings us up to date on Cigna’s efforts to prevent a former executive from joining CVS Health.

From the opioids PHE front, the Wall Street Journal reports that the U.S. government has begun deploying X-ray scanners for trucks crossing the border from Mexico, first in Brownsville, Texas:

The scanners in Brownsville beam energy at a truck in varying levels of intensity. Beaming less energy at the cab allows drivers to stay inside, speeding the process. Directing more energy at the trailer produces an image of the truck that officials can use to spot suspect material within. Sometimes the payload is illicit drugs including fentanyl. * * *

The U.S. aims to deploy 123 large-scale scanners along the border by fiscal 2026, growing its ability to perform nonintrusive scans to 70% of cargo vehicles and 40% of passenger vehicles, according to the White House Office of National Drug Control Policy. Historically, the U.S. has only performed such scans on 17% of cargo vehicles and 2% of passenger vehicles, the office said.

Adding more scanning technology has to be part of an effort that includes trying to reduce drug demand and the odds overdoses will prove fatal, said David Luckey, a senior Rand Corp. researcher. He co-led a team that produced a report last year for a commission on synthetic opioids that includes members of Congress and law-enforcement agencies.

“There’s no silver bullet,” he said.

From the No Surprises Act front, HHS Secretary Xavier Becerra told the Senate Budget Committee on March 22

Becerra said the agency has received more than 10 times as many No Surprises Act claims than it expected when the law was first implemented. Many of these claims are frivolous, he said, because there is no cost to payers or providers to file a claim. 

“Everyone’s just filing all sorts of claims, and these arbitrators are trying to figure out what cases to handle,” Mr. Becerra said. “That’s what’s bogging down the system. 

The  agency is staying true to Congress’ intent with the law, Mr. Becerra said, but more legislative action is needed to deal with the high number of claims. 

“What we’re trying to do is have a system that works. I plead with you to help us make sure that we get to the legitimate cases, so a provider that’s looking for real payment, or an insurer that’s saying, You’re asking for too much,’ we can adjudicate that,” Mr. Becerra said. 

The FEHBlog is metaphysically certain that providers are submitting 99.4% of the faulty arbitration claims. While the law is working for patients, Congress should tweak that law as the good Secretary requests.

From the U.S. healthcare business front, Fierce Healthcare informs us

Average physician pay fell by 2.4% from 2021 to 2022, and that decline in physician compensation comes at a time when U.S. healthcare workers are facing significant challenges, including economic strains, a growing physician shortage issue and high rates of work-related burnout, according to the sixth annual Physician Compensation Report from professional medical network Doximity. 

Fierce Healthcare’s report is chock-a-block full of summary data from this report.

In other news

  • The New York Times reports
    • The prevalence of autism spectrum disorder in American children rose between 2018 and 2020, continuing a long-running trend, according to a study released by the Centers for Disease Control and Prevention on Thursday. In 2020, an estimated one in 36 8-year-olds had autism, up from one in 44 in 2018. The prevalence was roughly 4 percent in boys and 1 percent in girls.
    • The rise does not necessarily mean that autism has become more common among children, and it could stem from other factors, such as increased awareness and screening.
    • “I have a feeling that this is just more discovery,” said Catherine Lord, a professor of psychiatry at the University of California, Los Angeles medical school, who was not involved in the research. “The question is what’s happening next to these kids, and are they getting services?”
  • HR Dive discusses a recent survey on employee use of employer-sponsored mental health benefits.
  • CNBC tells us
    • Drugmakers Sanofi and Regeneron * * * released data on a jointly developed drug that shows promise in treating COPD.
    • The drug is already approved for asthma and some skin conditions, such as eczema, but it could become the first new treatment in over a decade for COPD. 
    • The results are a win for Dupixent, as competing COPD drugs from drugmakers such as AstraZeneca and GSK struggle to make successful strides toward approval.