Monday Roundup

No Surprises Act

Monday Roundup

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Mental health care, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports
    • “House Republicans unveiled a stopgap funding measure Sunday night that would avoid a partial government shutdown next month and provide border security measures sought by conservatives. But passage even in the GOP-controlled House was already in doubt as some hard-liners came out against the measure Sunday night while the ink on it was barely dry.
    • “The draft continuing resolution would extend current funding through Oct. 31, while cutting 8.1 percent from all nondefense accounts except for the Department of Veterans Affairs and disaster relief. That extension would give lawmakers an extra month to try to complete fiscal 2024 appropriations that are otherwise needed by Sept. 30. * * *
    • “The bill is set for floor consideration this week, along with the fiscal 2024 Defense spending bill that stalled last week when conservative detractors threatened to vote against the rule needed to take it up.”
  • Politico discusses where we stand with the proposed mental health parity rule changes.
    • “The Biden administration’s proposal substantially expands the law Bush signed. It would mandate that insurers analyze the outcomes of their coverage to ensure there’s equivalent access to mental health care and take action to comply if they’re falling short.
    • “Insurers respond: AHIP, the lobbying group for insurers, says the situation is more complicated than Biden makes out, and workforce shortages are behind barriers to access.
    • “For years, health insurance providers have implemented programs and strategies to expand networks and increase access,” AHIP spokesperson Kristine Grow said in a statement.
    • “The administration has set a deadline for comments on its proposed rules for early October; insurers and their allies are asking for more time to respond.
    • “The ERISA Industry Committee, which represents large employers’ benefit interests, joined AHIP, among other associations, employers and health plans, in writing to administration officials to ask that the comment period on the proposed rules be extended. They warned that the rules could create “unnecessary burdens” for providers, insurers and patients and “unintentionally” impede access to care.”
  • The Centers for Medicare and Medicaid Services (CMS) announced on its No Surprises Act website today:
    • “Federal IDR Process update: Certain functions of the Federal IDR Process are temporarily paused in response to the TMA III Court Order.  On September 5, 2023, the Departments directed certified IDR entities to resume making eligibility and conflict of interest determinations and encouraged disputing parties to continue engaging in open negotiations.  The Departments expect to direct certified IDR entities to resume issuing payment determinations for some disputes very soon.”
  • The Office of Management and Budget’s Office of Information and Regulatory Affairs has completed work on a regulation that will affect the FEHB:
    • AGENCY: HHS-CMS RIN: 0938-AT86 Status: Concluded
    • TITLE: Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061) Section 3(f)(1) Significant: No
    • STAGE: Final Rule Economically Significant: No
    • RECEIVED DATE: 03/01/2022 LEGAL DEADLINE: Statutory
    • REVIEW EXTENDED
    • COMPLETED: 09/11/2023 COMPLETED ACTION: Consistent with Change
  • The FEHBlog will be watching the Federal Register for this one.
  • CMS also “finalized a rule to streamline enrollment in the Medicare Savings Programs (MSPs), making coverage more affordable for an estimated 860,000 people.”

From the public health and medical research fronts,

  • Per Healthcare Dive, “New RSV vaccines can be powerful tools, but rollout poses test; The recently approved shots will slot in alongside vaccines for influenza and COVID-19 this fall, raising communication challenges for public health officials.” The article dives into the details, but health plans can help communicate new vaccines’ benefits to their members with young kids and members who have reached senior citizen status.
  • NPR reports,
    • “The mixture of stimulants like cocaine and meth with highly potent synthetic opioids is a fast-growing driver of fatal overdoses in the U.S.
    • “Since 2010, overdoses involving both stimulants and fentanyl have increased 50-fold, and now account for 32% of U.S. overdoses in 2021 and nearly 35,000 deaths, according to a study published Thursday in the scientific journal Addiction.
    • “We’re now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the U.S. overdose crisis,” says Joseph Friedman, the lead author of the study and a researcher at UCLA’s David Geffen School of Medicine. “Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances.”
  • Healio points out that based on a recent research study,
    • “Consumption of added sugar, total sugar, total glucose equivalent and fructose from added sugar and juice were linked to a higher risk for coronary heart disease.
    • “Fructose from vegetables and fruits was not.”
  • The American Medical Association informs us, “What doctors wish patients knew about social isolation.”
  • Health Day notes based on a Swedish study,
    • “Chronic acid reflux — also known as GERD — has long been thought to boost a person’s risk of esophageal cancer
    • “A new study refutes that, finding that only patients with evidence of injury to their esophagus from reflux have a higher cancer risk
    • “Researchers downplayed a “very moderate” increased risk for women, saying that it remains “extremely low.'”
  • MedPage Today calls our attention to a different Swedish study,
    • “Bariatric surgery for obesity was associated with a reduced risk of hematologic cancers in a prospective Swedish study spanning more than three decades.”
  • Per NIH,
    • “Artificial intelligence (AI) and machine learning (ML) can effectively detect and diagnose Polycystic Ovary Syndrome (PCOS), which is the most common hormone disorder among women, typically between ages 15 and 45, according to a new study by the National Institutes of Health. Researchers systematically reviewed published scientific studies that used AI/ML to analyze data to diagnose and classify PCOS and found that AI/ML based programs were able to successfully detect PCOS.
    • “Given the large burden of under- and mis-diagnosed PCOS in the community and its potentially serious outcomes, we wanted to identify the utility of AI/ML in the identification of patients that may be at risk for PCOS,” said Janet Hall, M.D., senior investigator and endocrinologist at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, and a study co-author. “The effectiveness of AI and machine learning in detecting PCOS was even more impressive than we had thought.”

From the U.S. healthcare business and quality fronts,

  • Beckers Payer Issues reports
    • The National Committee for Quality Assurance has named the best-rated health plans of 2023 based on factors that include care quality, patient satisfaction and efforts to keep improving.
    • The ratings were released Sept. 15 and are based on 2022 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover more than 200 million people. NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 1,095 plans received a rating. No Medicaid or Medicare plan received 5-stars this year.
    • Commercial plans that received a five-star rating:
      • Independent Health Association (New York)
      • Kaiser Foundation Health Plan of the Mid-Atlantic States (Washington D.C., Maryland, Virginia)
  • Per Healthcare Dive
    • ‘Hospitals have been required to post their prices for shoppable services online since 2021, but costs shared online rarely correlate to prices hospitals share with consumers on the phone, according to a new secret shopper survey.
    • ‘The study found wide variations when comparing hospitals’ online cash prices for childbirth and brain imaging with prices told to consumers who inquire over the phone.
    • ‘For example, researchers found five hospitals with online prices greater than $20,000 for vaginal childbirth but telephone prices less than $10,000. For a brain magnetic resonance imaging scan, two hospitals said the cost was more than $5,000 over the phone, but the price tag was $2,000 online.’
    • That’s a big bowl of wrong.
  • Reuters reports,
    • “Novo Nordisk (NOVOb.CO) has hired U.S. private contract manufacturer PCI Pharma Services to handle assembly and packaging of Wegovy, a source familiar with the matter said, as it races to boost output of the weight-loss drug to meet demand.
    • “Philadelphia-based PCI, which has 15 facilities in North America, Europe and Australia, is putting together the self-injection pens used to administer Wegovy, said the source, who declined to be named because the information is confidential.”
  • mHealth Intelligence tells us
    • The percentage of asynchronous telehealth claim lines for mental health conditions increased nationwide, with a particularly sharp rise in the Midwest, where it doubled between May and June, according to new telehealth usage data.
    • The data from FAIR Health’s Monthly Telehealth Regional Tracker represents the privately insured population, including Medicare Advantage and excluding Medicare Fee-for-Service and Medicaid. The tracker, launched in May 2020, uses data from FAIR Health to provide insights into month-to-month changes in the volume of telehealth claim lines and audio-only telehealth usage.
    • Nationally, telehealth remained stable at 5.4 percent of claim lines in May and June. In three US regions, telehealth use did not change during this period, but usage fell by 2.4 percent in the Midwest.

In general business news, HR Dive offers “A running list of states and localities that require employers to disclose pay or pay ranges.”

Friday Factoids

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

From the No Surprises Act front,

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

From Washington, DC —

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

From the medical and Rx research fronts —

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

From the U.S. healthcare business front,

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

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.