Midweek update

Medical / Rx research

Midweek update

David Ermer–Generative AI, Medical / Rx research, Mental health care, Patient safety, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC —

  • STAT News tells us,
    • “Ahead of a major Food and Drug Administration meeting on a new Alzheimer’s treatment this week, several Democratic lawmakers are ratcheting up their criticism of how the Biden administration is planning to handle a potential approval this summer.
    • “Sen. Bernie Sanders (I-Vt.), who leads the Senate’s health committee, wrote to health secretary Xavier Becerra on Wednesday asking him to ”use the full extent” of his authority to ensure Medicare doesn’t pay the list price of $26,500 for Eisai and Biogen’s Leqembi.”

From the U.S. healthcare business front —

  • Healthcare Dive informs us,
    • “The financial performance of the seven largest publicly traded U.S.-based insurers remains stable so far this year, despite “continued challenges” in the healthcare sector, according to a report out Tuesday from credit ratings agency Fitch Ratings.
    • “Though persistent staffing shortages and high inflation has been pressuring healthcare providers, the largest payers, which Fitch estimates to account for about 70% of the privately ensured U.S. population, reported a 7.7% operating EBITDA margin in the first quarter compared with 7.6% during the same period in 2022.
    • “However, the report noted that cost pressures at the provider level could impact payer and provider contract negotiations and cause premium rates to increase over the next few years, contributing to “heightened public discourse around healthcare costs for consumers.”
  • Per the Lown Institute —
    • A recent New York Times investigation found that Allina Health System, a nonprofit health system in the Midwest, has been rejecting patients for appointments if they have unpaid medical bills. If patients amass at least $1,500 in medical debt three separate times, they may not be allowed to come back to a clinic or hospital until they pay up. In many cases, Allina’s electronic health record system precludes doctors from making new appointments with patients that have unpaid debt.
    • The policy, which was started in 2006, applies to patients struggling with chronic conditions like diabetes and depression, and is even applied to children. The Times heard from doctors and patients who described being unable to complete medical forms that children needed to enroll in day care or show proof of vaccination for school. Allina’s dominance in the region also means that patients who are rejected for care–especially patients in rural areas–may have trouble finding other providers. 
    • How is a nonprofit system allowed to deny needed care for patients with debt? While nonprofit hospitals are required by federal law to accept any patient for emergency care regardless of ability to pay, the same requirement doesn’t apply to non-emergency care. 
    • Because there aren’t regulations against this practice, Allina is not alone in rejecting patients with debt. According to a 2022 KFF Health News investigation of 528 hospitals sampled nationwide, 55 indicated in their written policy that they do allow deniels of non-emergency care for patients with medical debt, 22 said this is allowed but not current practice, and 85 others had no information in their policy on whether or not they do this. (Allina Health Faribault Medical Center was included in this last group, but no other Allina hospitals were included in the study). Among the hospitals that allow for care denials are within some of the largest nonprofit systems in the country, including Ascension, Indiana University Health, Cedars-Sinai Medical Center, Mayo Clinic, Trinity Health, and more.

From the healthcare research front, BioPharma Dive offers its wrap-up report on the ASCO conference held in Chicago this week.

From the SDOH front —

  • Healthcare Dive points out,
  • “Patients of color, or those on public insurance, are still at increased risk for certain adverse events compared to White patients, regardless of high hospital safety ratings, according to a report out Wednesday from the Leapfrog Group.
  • “Although higher hospital safety ratings generally correspond with fewer adverse safety events, the report found that pattern doesn’t hold true for patients of color or those on Medicare or Medicaid, who were more likely to experience adverse events after surgery, including sepsis, blood clots and respiratory failure.
  • “Rather than suggesting problems with individual hospitals, the data points to a “systemic issue impacting the quality of care for Black and Hispanic patients and those with public insurance plans,” according to the report.”

From the mental healthcare front, Health Payer Intelligence discusses six strategies that payers can use to promote behavioral health prevention, along with a strong provider network.

From the litigation front —

  • Fierce Healthcare reports
    • “A federal appeals court held a brief hearing Tuesday afternoon to hear from attorneys on both sides as it decides whether to lift a nationwide freeze on a lower court’s ruling that struck down preventive care protections in the Affordable Care Act (ACA).
    • “A panel of judges at the Fifth Circuit Court of Appeals, based in New Orleans, issued a stay on the District Court ruling while the appeals process plays out, though it could choose to lift the stay following Tuesday’s hearing. Legal experts expect a decision on the pause in short order.”
  • The FEHBlog is willing to bet the ranch that the panel will uphold the existing stay.

From the generative AI front —

  • Healthcare Dive relates
    • “Google is linking up with longtime collaborator Mayo Clinic to explore generative artificial intelligence’s applications in the hospital, the tech giant announced Wednesday morning.
    • “Mayo will use a Google Cloud tool that lets organizations create chatbots and search applications using generative AI to answer complex questions and produce summaries faster than traditional search functionalities.
    • “Mayo could improve the efficiency of clinical workflows and make it easier for clinicians and researchers to find information, Google said.”

In federal employee benefits news, Federal News Network tells us

  • “The Office of Personnel Management’s backlog of retirement claims dropped by 2,259 in May. OPM received 6,096 claims, just over 2,200 fewer than in April, which saw 8,298. OPM processed 8,355 claims, bringing down the inventory backlog to 18,125, the lowest it has been since June 2020, when it reached 17,432.
  • “OPM still has improvements to make, as the inventory backlog is more than 5,000 claims above the steady state goal of 13,000.”

Tuesday Tidbits

David Ermer–Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front —

  • STAT News reports,
    • “Ten years ago, clinicians in a handful of hospitals around the United States began sequencing the genomes of apparently healthy babies, seeking to understand how the technology might turn up hidden genetic disorders that aren’t being caught by routine newborn blood testing. New research from one such trial suggests the impact of having that kind of information extends far beyond the baby whose DNA is being decoded.
    • “In a study published Monday in the American Journal of Human Genetics, researchers from Mass General Brigham and Boston Children’s Hospital reported that of the first 159 infants to undergo screening through genomic sequencing, 17 were discovered to have unanticipated mutations in disease-associated genes.
    • “Over the next three to five years, in the majority of the 17 infants’ families, these discoveries prompted parents and other relatives to get additional testing that led to uncovering the cause of diseases running through their family trees. In three cases, mothers who learned they carried a gene that drastically elevated their risks of certain cancers chose to undergo prophylactic surgeries to reduce those risks — a finding that the lead researcher says undercuts ethical objections to informing families of genetic findings even when they aren’t immediately actionable for the newborn.
    • “This is a real-world rebuttal to the prevailing notion that we should not be sharing adult-onset disease-risk variants in children,” said Robert Green, a medical geneticist at Harvard and Brigham and Women’s Hospital who leads the BabySeq study that produced the new research. “There are ethicists who say a child should not be used as a genetic canary in a coal mine — that one member of a family should not be used without their consent as the access point for a whole family, but I’d like to challenge that. Look at these mothers. We arguably saved their lives. Are you really going to put that up against a theoretical loss of autonomy at some point in the child’s future?”
  • Health Day tells us,
    • “Women who consistently adhered to mammography guidelines had better odds for survival if they were then diagnosed with breast cancer, study found.
    • “Delays in screening can contribute to being diagnosed with advanced disease.
    • “The findings were to be presented [last] Sunday at the annual meeting of the American Society of Clinical Oncology in Chicago. Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.
    • “There has been much debate about when to start breast cancer screening, how often screening should occur, and how many screening exams are necessary. “This study suggests that a missed breast cancer screening has consequences,” said Dr. Arif Kamal, chief patient officer for the American Cancer Society.”
  • The NIH Director discusses “Encouraging First-in-Human Results for a Promising [mRNA] HIV Vaccine.”
  • As we enter the summer months, Bloomberg Prognosis provides insights into suncreens.

From the U.S. healthcare business front —

  • STAT News and EndPoints offer fascinating interviews respectively with Susan Galbraith, head of AstraZeneca’s oncology research and development and Emma Walmsley, the Glaxo Smith Kline (GSK) chief executive officer.
  • Beckers Hospital Review ranks health systems by operating margins.
  • The Wall Street Journal examines why “a growing group of physicians are ditching medicine’s traditional career path and hitting the road as temporary doctors-for-hire.”
  • Kaiser Foundation News reports that doctors of osteopathy are filling the growing MD gap in rural areas of the U.S.
  • MedCity News reports that “Doulas — who provide physical, emotional and informational support to expectant mothers — have shown to improve maternal health outcomes, but there’s little insurance coverage of their services. That’s starting to change, however, particularly in Medicaid programs.”
  • Fierce Healthcare tells us,
    • “Evernorth has inked a strategic partnership with CarepathRx Health System Solutions that aims to boost access to specialty pharmacy care.
    • “Through the partnership, the two will provide integrated specialty pharmacy services to CHSS’ growing clientele, which includes more than 600 hospitals, health systems and physicians. This will allow these providers to diversify the ways they can support patients, according to an announcement.
    • “As part of the partnership, Evernorth will make a “significant minority investment” in CHSS that it expects to close late in the second quarter or in the third quarter of 2023.”
  • and
    • “Humana’s primary care arm opened its 250th clinic in Dallas on Tuesday, marking another milestone in the insurer’s growth in the provider space.
    • “The Medicare Advantage giant has established a multiyear effort to continue scaling CenterWell and expects to open between 30 and 50 centers per year through 2025. In addition to the senior-focused primary care clinics, CenterWell also houses Humana’s home health business, another key strategic focus, and is sister to the Conviva Care Center brand.
    • “Collectively, Humana’s Primary Care Organization cares for 266,000 seniors across its markets.
    • “The ongoing expansion cements CenterWell as one of the country’s fastest-growing providers of value-based, senior-focused care. It operates clinics in 12 states: Arizona, Florida, Georgia, Kansas, Kentucky, Louisiana, Missouri, Nevada, North Carolina, South Carolina, Tennessee and Texas.”

From the litigation front —

  • Roll Call tells us,
    • “Drugmaker Merck & Co. Inc. sued the federal government Tuesday, seeking an injunction against parts of last year’s reconciliation law that allow the Health and Human Services Department to negotiate for lower prices on [a certain subset of prescription] drugs.
    • “The lawsuit, filed in the U.S. District Court for the District of Columbia, argues that the negotiation program is “extortion” and violates the Fifth Amendment by not paying the company “just compensation” for its products.
    • “By coercing Merck to provide its drug products at government-set prices, the Program takes property for public use without just compensation in violation of the Fifth Amendment,” Robert Josephson, Merck’s executive director of global media relations, said in a statement.”
  • Beckers Payer Issues relates,
    • “A federal judge in St. Louis issued a preliminary injunction barring former Cigna executive Amy Bricker from working for CVS Health, while a lawsuit over her noncompete clause moves forward. 
    • “In the June 5 order, Judge Ronnie White said that Ms. Bricker is prohibited from providing any services to CVS Pharmacy, CVS Health, any of its entities or any other business that is “engaged in a business similar to, or that competes with, the business of Cigna.” She is also barred from disclosing Cigna trade secrets or confidential information.” 

From the miscellany / tidbits department

  • The Office of National Health Information Technology Coordinator released
    • “the draft USCDI+ Quality data element list for public comment on the eCQI Resource Center website. This release provides an initial, high-level picture of the USCDI+ initiative in action. It is a harmonized set of data elements for quality measurement that could be used to support measurement and reporting across a wide number of quality programs. ONC requests feedback on this draft list by 11:59pm ET on June 30, 2023, particularly its level of completeness, level of specificity, and the usefulness of companion guidance.
    • “The draft USCDI+ Quality is the most recent milestone for the USCDI+ initiative, which supports our federal agency partners to build on the USCDI standard adopted by ONC in 2020 and was first described in this blogfrom October 2021. The draft USCDI+ Quality includes data elements in the USCDI; however, as a core data set, the USCDI standard itself does not include each data element needed for quality measurement use cases. Through USCDI+ Quality, ONC is seeking to extend from the USCDI model to establish a consistent baseline of harmonized data elements for a wide range of CMS and other quality measurement use cases. Once mature, the USCDI+ Quality data element list can inform technical specifications and implementation guidance needed to enable more flexible, modernized, and robust approaches to standardizing and sharing data.”
  • Fierce Healthcare adds,
    • “The roughly half of American smartphone users with iPhones will notice new health and privacy features on their devices starting today.
    • “In addition to iPhones being equipped with new health features, Apple’s update will give iPad and Apple Watch users access to new tools. All three platforms will gain features that encourage healthy behaviors, reduce the risk of myopia, or nearsightedness, and provide ways to assess and address depression, according to the company. The new features were announced as part of Apple’s Worldwide Developers Conference 2023Monday.
    • “By bringing the Health app to the iPad, the tech giant hopes to inspire even more Apple users to take a proactive approach to their health.
    • “Our goal is to empower people to take charge of their own health journey. With these innovative new features, we’re expanding the comprehensive range of health and wellness tools that we offer our users across iPhone, iPad and Apple Watch,” said Sumbul Desai, M.D., Apple’s vice president of Health, in a press release. “Mental health and vision health are important, but often overlooked, and we’re excited to introduce features that offer valuable new insights to provide users with an even better understanding of their health. These insights help support users in their daily decisions and offer more informed conversations with their doctors.”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • Healthcare Finance tells us,
    • “On Tuesday, the American Medical Association, the Institute for Healthcare Improvement (IHI) and Race Forward officially launched Rise to Health, a call to action for providers, payers, pharma and professional societies to make health equity a priority.
    • “Rise to Health will have enforcement teeth in the form of establishing a set of measures across numerous participants.
    • “That’s what we are observing as a critical defining difference,” said IHI president and CEO Dr. Kedar Mate. 
    • “Dr. Aletha Maybank, AMA chief health equity officer and senior vice president called it “collective accountability.”
    • “We need data measurement,” Maybank said. “There’s a whole measurement component, with input from different folks.”
    • “Rise to Health: A National Coalition for Equity in Health Care has been in the works for about two years. Its ten founders include the AMA, American Hospital Association and AHIP.”
  • The American Hospital Association reports,
    • “The FDA today told AHA that is has worked with Qilu Pharmaceuticals and Apotex Corp. to temporarily import cisplatin, a drug used in chemotherapy, after a national shortage. FDA said it is carefully assessing the overseas product for quality to ensure it is safe for U.S. patients. The agency issued a “Dear Health Care Provider” letter with details and updated its drug shortage database with more information.”

From the public health front —

  • US News and World Report informs us,
    • “Almost all Americans have some level of immunity against COVID-19 through vaccination, previous infection or both, suggests new research from the Centers for Disease Control and Prevention.
    • “The study, which was published Thursday, tested blood donations from people ages 16 years and older for antibodies against the coronavirus from July through September 2022.
    • “It found that 96% of people had antibodies by last fall. About 23% were from infection alone and 26% were from vaccination alone. Nearly 48% had hybrid immunity – a number that’s only expected to grow as the coronavirus continues to circulate.
    • “Hybrid immunity, or the combination of protection from vaccination and infection, is believed to be higher and longer lasting than protection from either source on its own.
    • “This increase in seroprevalence, including hybrid immunity, is likely contributing to lower rates of severe disease and death from COVID-19 in 2022–2023 than during the early pandemic,” the authors wrote.”
  • The American Hospital Association relates,
    • “The Centers for Disease Control and Prevention is following up on a previous alert of an outbreak of suspected fungal meningitis in Texas, which is now significantly expanded to multiple states. A total of 212 residents in 25 U.S. states and jurisdictions have been identified who might be at risk of fungal meningitis because they received epidural anesthesia at clinics in Matamoros, Mexico, during cosmetic procedures.
    • The CDC is urging all patients, including those without symptoms, who underwent medical or surgical procedures under epidural anesthesia at River Side Surgical Center or Clinica K-3 in Matamoros, Mexico, since Jan. 1, 2023, should be evaluated for fungal meningitis as soon as possible. Health care providers should immediately report possible fungal meningitis cases possibly related to this outbreak to their state or local health department.” 
  • Health Day points out,
    • “The number of American women who have diabetes when they become pregnant has increased dramatically over five years, health officials reported Wednesday. 
    • “Between 2016 and 2021, the rate of pregnancy among diabetic women has risen 27%, from about 9 per 1,000 births to 11 per 1,000 births, according to the report from the U.S. Centers for Disease Control and Prevention. 
    • “Primary reasons for this increase are most likely the ongoing obesity epidemic and the fact that more older women are having children.”
  • The Wall Street Journal offers an essay discussing why are our knees are so easy to injure.

From the research front, BioPharma Dive reports,

  • A targeted drug from Novartis reduced the risk of breast cancer returning by 25% versus standard treatment when used after surgery in people vulnerable to a relapse, according to clinical trial data released Friday.
  • The findings, which will be presented at the American Society of Clinical Oncology’s annual meeting in Chicago, give Novartis a chance at Food and Drug Administration approval for its drug in this so-called adjuvant setting. A competing therapy from Eli Lilly won a similar OK a year and a half ago.
  • Novartis announced in March that the trial, called NATALEE, had succeeded, but didn’t disclose details. The full findings now released give breast cancer doctors an opportunity to evaluate how the drug, known as ribociclib and sold as Kisqali, might fit in treatment.

Midweek update

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC —

  • The Wall Street Journal reports,
    • “The House passed a sweeping bill that suspends the federal government’s $31.4 trillion debt ceiling in exchange for spending cuts, as Republican Speaker Kevin McCarthy muscled through a deal struck with President Biden to avert a looming government default.
    • “The 314-117 vote relied on support from both Republicans and Democrats. Passage of the deal sends the measure to the Senate, where leaders have promised quick action, and Biden has said he is eager to sign the measure into law. Treasury Secretary Janet Yellen has said the government could run out of the cash it needs on June 5 to pay its bills on time and warned of severe economic damage and market disruptions unless Congress acts.
    • “The House vote marks the culmination of a hard-fought debate in the chamber, where Republicans were intent on using the debt ceiling as leverage to deeply cut deficit spending and roll back many of Biden’s signature initiatives—but ended up settling for more modest changes.
    • “The outcome showed, for now, that McCarthy has the power to deliver high-stakes deals with Democrats while still keeping his job, and bolstered Biden’s reputation as a deal maker who was willing to find a middle ground with Republicans.”
  • Healthcare Dive provides details on the healthcare provisions in the bill (HR 3746).
  • STAT News tells us
    • “As Congress considers wide-ranging reforms to pharmacy benefit managers, a top executive at CVS Health, which owns one of the largest PBMs in the country, said the company would find ways to maintain its level of profit if those reforms to things like drug rebates went into effect.
    • “There’s other ways in the economic model that we can adjust to if one of those things changes,” Shawn Guertin, CVS’ chief financial officer, said at an industry conference Wednesday. “The other important part of this, if some of these things change, it could lead to higher costs for employers and health plans.”
  • If the FEHBP’s experience with transparent prescription drug pricing is any guide, the reforms under consideration will not lower costs for employers and health plans. For example, OPM mandated full transparency of manufacturer rebates and 100% distribution of those rebates to the health plans, causing higher administrative expenses for FEHB plans. Presumably, the larger rebates and higher administrative expenses wash. OPM also mandates triennial RFP processes for PBM contracts which do produce savings.

Speaking of FEHBP, Govexec brings us up to date on Postal Service Health Benefits Program implementation. The article illustrates the support that carriers and the Postal Services, among other agencies, are providing OPM with this project. All of the major Postal unions are FEHB carriers.

Today is the deadline for FEHB carriers to submit their 2024 benefit and rate proposals to OPM. Fierce Healthcare discusses a Mercer survey of employer expectations for 2024 premiums.

From the public health front —

  • Kaiser Family Foundation News points out that medical debt is materially higher in the Diabetes Belt found in the southeastern U.S. “The CDC says the Diabetes Belt consists of 644 mostly Southern counties where rates of the disease are high. NPR found that more than half of the counties have high levels of medical debt in collections — meaning at least 1 in 5 people are affected.”
  • Healio relates
    • Compared with reoffering colonoscopy and fecal immunochemical test alone, offering a blood test as a secondary option resulted in a nearly twofold increase in colorectal cancer screening in veterans who had declined first-line screening. 
    • “We know screening prevents colorectal cancer, but participation in screening is suboptimal,” Peter S. Liang, MD, MPH, assistant professor of medicine and population health at NYU Langone Health, told Healio. “Compared to widely used screening modalities such as colonoscopy and stool-based testing, a blood test has certain advantages: It is noninvasive, can be done at point of care and does not require self-collection.”
  • Leapfrog Group calls attention to its newly released 2023 maternity care report.
  • STAT News explains why new cancer patients need navigation support
    • [P]eople * * * in this suspected peri-diagnostic period (the time between a positive finding on a screening test and leading up to a formal diagnosis and treatment) are not looking for specific answers so much as they are seeking general support.
    • Patients want a trusted person to help provide a general overview of the journey ahead. They want someone to help them through the structural and logistical challenges of our cumbersome and sometimes unresponsive health systems. They would like triage on whether their case is common enough that they can access high-quality, convenient, and accessible community care, or whether their diagnosis warrants the specialized care available at large academic medical centers. They want guidance on what sorts of questions to ask their care team. They want to know if they should pursue second opinions, and if so, how to go about getting insurance approval or the mechanics of how to actually secure an appointment.
  • Medscape reports
    • “About 10% of people infected with Omicron reported having long COVID, a lower percentage than estimated for people infected with earlier strains of the coronavirus, says a study published in The Journal of the American Medical Association.”

From the Rx coverage front —

  • The Hill reports
    • “The Food and Drug Administration (FDA) on Wednesday approved Pfizer’s vaccine to prevent the respiratory disease RSV in older adults, the company announced.
    • The approval of Pfizer’s Abrysvo marks the second authorized RSV shot for older adults in the U.S. this month, after GlaxoSmithKline won approval for its rival shot, Arexvy. “
  • Medscape informs us
    • Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter (SGLT) 1 as well as SGLT2, received marketing approval from the US Food and Drug Administration (FDA) on May 26 for reducing the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and also for preventing these same events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.
    • This puts sotagliflozin in direct competition with two SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), that already have indications for preventing heart failure hospitalizations in patients with heart failure as well as approvals for type 2 diabetes and preservation of renal function.
    • Officials at Lexicon Pharmaceuticals, the company that developed and will market sotagliflozin under the trade name Inpefa, said in a press release that they expect US sales of the agent to begin before the end of June 2023. The release also highlighted that the approval broadly covered use in patients with heart failure across the full range of both reduced and preserved left ventricular ejection fractions.
    • Lexicon officials also said that the company will focus on marketing sotagliflozin for preventing near-term rehospitalizations of patients discharged after an episode of acute heart failure decompensation.

From the U.S. healthcare business front —

  • Beckers Hospital Review reports
    • “The median year-to-date operating margin index for hospitals slightly improved in April to 0 percent, according to Kaufman Hall. 
    • “The neutral margin marks a slight improvement from the -0.3 percent recorded in March, according to Kaufman Hall’s latest “National Flash Hospital Report” — based on data from more than 900 hospitals.
    • “Hospitals saw increased bad debt and charity care and decreased inpatient and outpatient volumes in April, which Kaufman Hall experts correlate to the winding down of the COVID-19 Public Health Emergency, which ended May 11.” 
  • Healthcare Dive tells us
    • “Nonprofit hospital and health plan operator Kaiser Permanente announced Tuesday that it was committing $10 million to safety-net hospital and regional operator Denver Health, as the facility struggles with “unprecedented financial challenges” including increased expenses and a rise in uninsured patients.
    • “Denver Health provides care for around 30% of the city’s population — including the largest percentage of uninsured patients. The system has struggled with a rise in costs and a surge in sicker patients, with expenses totaling $1.3 billion for Denver Health in fiscal year 2022.
    • “The announcement comes as both nonprofit and for-profit hospitals across the country struggle with negative margins and pent-up financial challenges stemming from the COVID-19 pandemic, including persistent heightened contract labor costs, inflationary pressures and unfavorable payer mixes.”

From the miscellany department —

  • Bloomberg updates us on the promising hunt for a breast cancer vaccine.
  • MedCity News relates
    • About 65% of Americans believe that employer-sponsored insurance provides them with “financial peace of mind,” a new survey shows.
    • The AHIP report, published Wednesday, was conducted by Locust Street Group from April 17 to April 25 as part of AHIP’s Coverage@Work campaign, which aims to gather insights on Americans’ thoughts on employer-sponsored coverage. It included responses from 1,000 U.S. consumers with employer-sponsored coverage.
  • Beckers Payer Issues ranks the States by Medicare Advantage enrollment.
  • The Society for Human Resource Management reports
    • “In a memo released May 30, National Labor Relations Board (NLRB) General Counsel Jennifer Abruzzo announced that noncompete agreements violate the National Labor Relations Act (NLRA). The announcement, which applies to nonunionized and unionized employers, may result in unfair labor practice charges for any employer that uses noncompetes, said Thomas Payne, an attorney with Barnes & Thornburg in Indianapolis.
    • “However, a manager’s or supervisor’s noncompete would seemingly be unaffected by the memo because the NLRA applies only to nonmanagerial, nonsupervisory staff, said James Redeker, an attorney with Duane Morris in Philadelphia.  Managers and supervisors are the most likely to have noncompetes, he noted.”

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, Electronic health records, FDA, Medical / Rx research, NIH, Rx coverage–
Photo by Josh Mills on Unsplash

From Washington, DC, —

  • The New York Times reports
    • “Top White House officials and Republican lawmakers were closing in on Thursday on a deal that would raise the debt limit for two years while capping federal spending on everything but the military and veterans for the same period. Officials were racing to cement an agreement in time to avert a federal default that is projected in just one week.
    • “The deal taking shape would allow Republicans to say that they were reducing some federal spending — even as spending on the military and veterans’ programs would continue to grow — and allow Democrats to say they had spared most domestic programs from significant cuts.
    • “Negotiators from both sides were talking into the evening and beginning to draft legislative text, though some details remained in flux.”
  • The Wall Street Journal adds
    • “The Treasury Department is preparing to change how the U.S. processes federal agencies’ payments if the debt ceiling is breached, dusting off a contingency plan crafted after the 2011 borrowing-limit standoff, people familiar with the matter said.
    • “Just days away from becoming unable to pay all of the government’s bills on time unless Congress raises the debt limit, Treasury officials have been quietly laying the groundwork for potentially delaying some payments after June 1.
    • “Under the backup plan created for a debt-limit breach, federal agencies would submit payments to the Treasury Department no sooner than the day before they are due, the people familiar with the talks said. That would represent a change from the current system, in which agencies may submit payment files well before their due dates. The Treasury Department processes them on a rolling basis, often ahead of the deadlines. Some payments are already sent to the department one day early, one person said. 
    • “The plan would enable the Treasury to make daily decisions about whether it can pay all of the government’s bills the next day.”
  • Back to the New York Times,
    • “The [U.S.] House of Representatives passed legislation on Thursday that would make permanent harsh criminal penalties and strict controls on fentanyl-related drugs, with scores of Democrats joining nearly all Republicans in a vote that reflected the political challenges of tackling what both parties consider America’s most pressing drug crisis.
    • “The bill, approved by a vote of 289 to 133, would permanently list fentanyl-related drugs as Schedule I controlled substances, a designation that mandates severe prison sentences for highly addictive, nonmedicinal chemicals, and which is now set to expire at the end of 2024.
    • “The bipartisan vote reflected agreement among Republicans and a solid bloc of Democrats that stiffening penalties for fentanyl-related drugs is a necessary component of the federal response to the crisis. According to the Centers for Disease Control and Prevention, there were roughly 75,000 synthetic opioid overdose deaths in 2022, with fentanyl being a main culprit.”
  • Federal News Network informs us
    • “With many agencies’ return-to-office plans still uncertain, Republicans on the House Oversight and Accountability Committee want to take matters into their own hands.
    • “GOP committee leaders changed their strategy for trying to get more federal telework data, now reaching out directly to agency heads. In a series of 25 letters, the lawmakers asked for up-to-date  numbers of teleworking federal employees, after saying the Biden administration was “not adequately tracking the specific levels of telework.”
    • “The Biden administration “has not provided current data about the specific amount of telework occurring within federal agencies or across the entire federal workforce. Furthermore, it has provided no objective evidence concerning the impact of elevated telework on agency performance — including any deleterious impacts,” lawmakers said in the letters, published May 18.”

From the Rx coverage front —

  • Today the Food and Drug Administration granted full marketing approval to Paxlovid, the Covid treatment pill, which in the FEHBlog’s opinion, brought us to the end of the pandemic. Here’s a link to a MedPage Today report on this FDA action
  • The Institute for Clinical and Economic Research released “a Final Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH).”
    • “Independent appraisal committee narrowly voted that currently available evidence for resmetirom is adequate to demonstrate a net health benefit over lifestyle management, whereas current evidence for obeticholic acid was deemed inadequate to demonstrate a net health benefit —
    • “ICER analyses suggest resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year assuming that short-term effects on liver fibrosis translate into longer-term reductions in cirrhosis; under the same assumptions, obeticholic acid would achieve common thresholds for cost-effectiveness if priced between $32,600 – $40,400 per year.
    • “Payers should develop coverage criteria based on non-invasive testing to foster equitable access to early detection and treatment across diverse communities.
  • BioPharma Dive tells us
    • “Apellis Pharmaceuticals on Thursday became the latest drugmaker to give up on a potential treatment for amyotrophic lateral sclerosis, a neurodegenerative disorder that has frustrated researchers for decades.
    • “The decision came after a Phase 2 trial showed no benefit for the drug, known as systemic pegcetacoplan, compared with a placebo. It failed to meet the primary endpoint, measured by a statistical tool called the Combined Assessment of Function and Survival, as well as secondary goals assessing overall function, survival, lung function and muscle strength.
    • “The final results weren’t a total surprise; an independent board monitoring the study had already advised the company not to start a second, “open-label” part of the trial that would have offered the medicine to all participants after the initial 52-week research period. Apellis executives had also signaled to analysts that the trial had a low chance of success.”

From the miscellany department —

  • The National Institutes of Health announced
    • “Initial findings from a study of nearly 10,000 Americans, many of whom had COVID-19, have uncovered new details about long COVID, the post-infection set of conditions that can affect nearly every tissue and organ in the body. Clinical symptoms can vary and include fatigue, brain fog, and dizziness, and last for months or years after a person has COVID-19. The research team, funded by the National Institutes of Health, also found that long COVID was more common and severe in study participants infected before the 2021 Omicron variant.
    • The study, published in JAMA, is coordinated through the NIH’s Researching COVID to Enhance Recovery initiative, a nationwide effort dedicated to understanding why some people develop long-term symptoms following COVID-19, and most importantly, how to detect, treat, and prevent long COVID. The researchers hope this study is the next step toward potential treatments for long COVID, which affects the health and well-being of millions of Americans.
  • The New York Times discusses the miraculous case of a paralyzed man who has begun to walk again thanks to brain and spine “implants that provided a “digital bridge” between his brain and his spinal cord, bypassing injured sections” of his body.
  • HealthDay relates
    • “Older Americans are increasingly likely to log into “patient portals” to access their health care information — but confidence levels vary. 
    • “About 78% of people aged 50 to 80 now use at least one patient portal, according to the new University of Michigan (U-M) National Poll on Healthy Aging. 
    • “Five years ago, just 51% in this age range used patient portals, the researchers said. 
    • “The poll also found that 55% of those who used patient portals had done so in the past month. About 49% had accounts on more than one portal. 
    • “This surge is partly due to the increase in use of telehealth visits, said Denise Anthony, the U-M School of Public Health professor who worked on the poll.
    • “This change makes access to secure portals even more important for older adults who want to see their doctors and other health care providers virtually. It also makes the disparities we found in our poll even more troubling,” Anthony said in a Michigan Medicine news release. 
    • “Older adults with annual household incomes below $60,000, and those who were Black or Hispanic, had lower rates of portal use. These groups were also less likely to say they’re comfortable using a portal.”
  • The Washington Post reports
    • “U.S. authorities have seized increasing quantities of illegal ketamine, according to new research, a trend that coincides with the psychedelic drug’s rising popularity as a treatment for mental health ailments.
    • “The number of ketamine seizures by federal, state and local law enforcement in the United States increased from 55 in 2017 to 247 in 2022, while the total weight increased by more than 1,000 percent over that time, according to a letter published Wednesday in JAMA Psychiatry. Most of the ketamine was in powder form, which could raise the risk of being adulterated with deadly drugs such as fentanyl.”

Midweek update

David Ermer–Congress, Electronic health records, End of the PHE, NE, Generative AI, Medical / Rx research–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “Negotiators worked Wednesday to reach an agreement on reining in government spending, which has emerged as the central hurdle to a deal to raise the debt ceiling, with a possible government default just a week away.
    • “U.S. stocks extended declines Wednesday, reflecting rising anxieties about the debt ceiling, with the Dow Jones Industrial Average posting a fourth-straight session of losses.
    • “The White House has offered a spending freeze for next year, while GOP negotiators have insisted that any deal must result in lower discretionary spending, calling it a critical step in starting to address the country’s growing debt, which now stands at $31.4 trillion.”

Healthcare Dive, MedPage Today, and Fierce Healthcare discuss a House Oversight and Accountability Committee hearing on prescription benefit managers held yesterday.

The House Energy and Commerce Committee cleared a bunch of healthcare-related bills for floor consideration today.

STAT News tells us, “Matt Eyles, CEO of America’s Health Insurance Plans, is leaving by this October, the lobbying group said Wednesday.” Good luck, Mr. Eyles.

From the public health front —

  • Helen Branswell, writing in STAT News, points out
    • :An impressive number of vaccines and monoclonal antibody products are racing toward the end of the development pipeline, with two products aimed at protecting children expected to receive approval from the Food and Drug Administration by autumn. One, a maternal vaccine developed by Pfizer, received a recommendation last week from FDA’s vaccine advisory committee.
    • “But there are sizable hurdles standing in the way of the implementation of these products, hurdles that could see the promise they offer squandered because of bureaucracy, health systems that don’t interact with one another, and steep price tags.”
  • Ms. Branswell discusses the hurdles with experts on the matter.
  • Forbes reports
    • This week, Achieve Life Sciences announced that its drug, cytisinicline, saw strong results in its latest phase III trial. While the drug has been used for decades in eastern Europe, it’s not yet been approved by the FDA. The drug works by targeting the nicotine receptors in the brain, CEO John Bencich tells Forbes. “It works to reduce the satisfaction you get while smoking, but also helps with the cravings and withdrawal symptoms.” 
    • The study, which followed 792 patients, had patients take the drug for either 6 weeks or 12 weeks. Both patients who received the drug and those who got a placebo also went through a behavioral program about quitting smoking. The company says that over 30% of those who took the drug for 12 weeks stopped smoking completely in the last four weeks of the study, compared to less than 10% in the placebo group. For six weeks of treatment, the drug had a nearly 15% success rate compared to 6% in the placebo group. The company saw similar success in a smaller study it reported in the spring on the success of the drug in helping patients quit vaping. Patients will be monitored for 24 weeks after completing the cessation program, and the company expects to file a new drug application with the FDA in the first half of 2024. 
  • This week’s Econtalk podcast offers an interview between host Russ Roberts and University of Chicago economist Casey Mulligan about the macroeconomic angles of public health issues, like the Covid pandemic. Check it out.

From the interoperability front,

  • Fierce Healthcare relates
    • The total number of Epic customers pledging to join the electronic medical record provider in its participation in the Trusted Exchange Framework and the Common Agreement (TEFCA) has jumped to 27. 
    • After announcing the participation of 20 health systems plus health tech company KeyCare and health information exchange OCHIN on Monday, five more organizations have joined the pledge including Kaiser Permanente.
    • According to Matt Doyle, interoperability software development lead at Epic, the EMR company is optimistic that nearly all of the 2,000 hospitals and 600,000 clinicians that use Epic across the country will participate. 
  • Let’s go.

From the generative AI front,

  • Patient Engagement HIT tells us
    • Can ChatGPT really replace doctors? Probably not, at least for right now, as surveying shows that patient trust in chatbots and generative AI in healthcare is relatively low.
    • The report from The University of Arizona Health Sciences showed that around half of patients don’t fully trust AI-powered medical advice, like the information issued from chatbots like ChatGPT. Instead, patients still trust and prefer their traditional healthcare providers.
    • However, patients may be more receptive to chatbot medical advice if the AI is guided by a doctor’s or human’s touch.

Tuesday’s Tidbits

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

From Washington, DC, the Wall Street Journal explains,

“President Biden and Democratic leaders in Congress approached this year’s debt-ceiling drama with a consistent mantra: They would absolutely never, ever, under any circumstances, negotiate over raising the country’s borrowing level.

“But now they are very much negotiating on the debt limit, just about a week before the June 1 date when the Treasury Department estimates the U.S. could run out of measures to avoid default. Talks are underway about how to find a package of spending cuts and other measures acceptable to enough Republicans and Democrats to clear Congress, with House Speaker Kevin McCarthy (R., Calif.) and Biden meeting Monday and planning further talks to craft a deal framework in coming days.

“We’re not there yet” on a deal, said McCarthy on Tuesday. White House press secretary Karine Jean-Pierre said: “While areas of disagreement remain, the president, the speaker and their teams will continue to discuss the path forward.”

Govexec adds,

“Most non-defense federal agencies appear headed for at least a spending freeze next fiscal year—if not an outright cut—as President Biden has offered to back down from his proposed spending increases in exchange for an increase to the government’s debt ceiling. 

House Republicans, who are spearheading negotiations with the White House to avoid a debt default that could occur as soon as June 1, have rejected that proposal, holding out for cuts compared to current spending levels. The two sides have been locked in marathon negotiations for the last week, agreeing to some costccc-cutting measures but remaining far from an overall agreement.”

 From the public health front —

  • Roll Call reports,
    • New HIV infections dropped 12 percent in 2021 compared to 2017, according to new Centers for Disease Control and Prevention estimates released Tuesday, with the biggest drops among young gay and bisexual men.
    • But the agency warned that HIV prevention efforts need to be accelerated to reach the national goals.
    • The data Tuesday credited the overall decrease to a 34 percent drop in infections among 13-24 year olds, with the largest declines among young gay and bisexual men. Annual HIV infections among young people decreased from 9,300 to 6,100, but among young LGBTQ men new infections dropped from 7,400 to 4,900.
  • McKinsey Health Institute released a survey shedding “light on the health perceptions and priorities of people aged 55 and older.”
    • “Among the results, unsurprisingly, is that older adults who have financial stability—no matter their country—are more likely than their peers to be able to adhere to healthy habits, including those that boost cognitive health.3 And contrary to the perception that older adults are tech laggards compared with their younger peers, the results find widespread technology adoption, especially in smartphone use, among the older adult population.”
  • The U.S. Preventive Services Task Force issued draft recommendations and evidence reviews for the following projects: Oral Health in Adults: Screening and Preventive Interventions and Oral Health in Children and Adolescents Ages 5 to 17 Years: Screening and Preventive Interventions. Both recommendations are “I” for inconclusive. The public comment submission deadline is June 30, 2023.
  • The U.S. Surgeon General Dr. Vivel Murthy circulated “a new Surgeon General’s Advisory on Social Media and Youth Mental Health – PDF. While social media may offer some benefits, there are ample indicators that social media can also pose a risk of harm to the mental health and well-being of children and adolescents. Social media use by young people is nearly universal, with up to 95% of young people ages 13-17 reporting using a social media platform and more than a third saying they use social media “almost constantly.”

From the medical research front —

  • The New York Times reports, “Researchers have for the first time recorded the brain’s firing patterns while a person is feeling chronic pain, paving the way for implanted devices to one day predict pain signals or even short-circuit them.”
  • The NIH Director’s Blog tells us, “Basic Researchers Discover Possible Target for Treating Brain Cancer.”

From the Rx coverage front —

  • The Drug Channels blog points out “The Top Pharmacy Benefit Managers of 2022: Market Share and Trends for the Biggest Companies.”
    • “We estimate that for 2022, about 80% of all equivalent prescription claims were processed by three companies: the Caremark business of CVS Health, the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group. 
    • “This concentration reflects the significant transactions and business relationships among the largest PBMs that have further concentrated market share. Five of the six largest PBMs are now jointly owned by organizations that also own a health insurer, as illustrated in Mapping the Vertical Integration of Insurers, PBMs, Specialty Pharmacies, and Providers: A May 2023 Update. 
      • “The big three PBMs’ aggregate share of claims was similar to the 2021 figure. Compared with 2021, however, Cigna’s share declined due to customer losses, while OptumRx’s share grew slightly. Two other notable market changes affected the 2022 figures:
      • “In January 2022, Caremark added the specialty business back to its Federal Employee Program (FEP) mail and clinical pharmacy services contract. The specialty portion of the FEP had transitioned to Prime Therapeutics in 2018. 
      • “In late 2022, Prime Therapeutics completed its acquisition of Magellan Rx from Centene. For 2022, Magellan Rx managed $22.9 billion in drug spend and had annual claims volume of 220.9 million. Magellan Rx annualized claims are included with Prime’s figures above.
    • “Beginning in 2024, Express Scripts will begin a five-year agreement to manage pharmacy benefits for more than 20 million Centene beneficiaries. We estimate that the Centene business will bring $35 to $40 billion in total gross pharmacy spend and more than 550 million prescriptions. This forthcoming shift of Centene’s PBM business from CVS Health’s Caremark to Cigna’s Express Scripts will significantly alter the relative position of these companies. 
  • MedPage Today informs us,
    • “The first nalmefene hydrochloride nasal spray (Opvee) won FDA approval for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and up, the agency announced.
    • “If administered quickly, the opioid receptor antagonist provides fast onset and long duration reversal of opioid-induced respiratory depression. It will be available for use by prescription in healthcare and community settings.”
  • The FDA announced
    • “approving Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. 
    • “According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines.”

From the generative artificial intelligence front, STAT News provides expert perspectives and answers readers’ common questions about AI and healthcare.

From the U.S. healthcare business front —

  • Healthcare Dive relates,
    • “The newly rebranded Intermountain Health reported $549 million in net income for the first three months of 2023, an increase from the prior-year period when the health system posted a $298 million net loss. 
    • “The Salt Lake City-based system brought in $4 billion in revenue compared with $2.8 billion in the period ended March 31 last year. 
    • “Intermountain’s expenses still climbed 44% to $3.7 billion, with a large portion coming from employee compensation and benefits at $1.7 billion. But supply costs grew too, reaching $703 million during the quarter, an increase of 46% from a year earlier.”
  • Fierce Healthcare notes,
    • “Cleveland Clinic is starting 2023 on the right side of zero, reporting Tuesday a Q1 operating income of $32.3 million (0.9% operating margin) and a net income of $335.5 million.
    • “Though the nonprofit system had reported a $1.2 billion net loss across 2022, the first quarter’s numbers continue the upward momentum Cleveland Clinic enjoyed at the end of last year.
    • “Like many health systems have reported in recent weeks, the performance is also a substantial bounce back from Q1 2022when the omicron wave dragged Cleveland Clinic to a $104.5 million operating loss (-3.4% operating margin) and a $282.5 million net loss.
    • “On a year-over-year basis, total unrestricted revenues grew 15.7% by way of a 13.3% rise in net patient revenue, to $3.1 billion, and a 37.3% increase in other restricted revenues, to $425.3 million.”

Weekend update

David Ermer–Congress, HSA, Medical / Rx research, Medicare, NIH, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

The House of Representatives will be in session for Committee business and floor voting, while the Senate will be on a State work week this week. The Senate press gallery informs us, “In today’s (5/18/23) wrap-up, Schumer reiterated that as discussions concerning the debt ceiling continue over the next week, Senators should be able to return to the Senate within a 24-hour period.”

The Wall Street Journal reports

“President Biden and House Speaker Kevin McCarthy agreed to meet Monday afternoon in a last-ditch effort to reach a deal to avoid a default on U.S. sovereign debt after negotiations to raise the federal borrowing limit reached an impasse.

“Talks between White House and House Republican negotiators largely ground to a halt this weekend, with both sides blaming the other for a failure to bridge their differences over spending levels. But Biden and McCarthy instructed their negotiating teams to resume their discussions, starting with a 6 p.m. meeting on Sunday. * * *

“There’s no agreement. We’re still apart,” McCarthy, a California Republican, told reporters at the Capitol, though he said the call with Biden was productive.” * * *

“Leaders in Washington are rushing to come up with a deal to lift the country’s borrowing limit. If they are unable to do so, the country might be unable to pay all of its bills as soon as June 1, according to an assessment by the U.S. Treasury Department.  

“Appearing Sunday on NBC, Treasury Secretary Janet Yellen said the “odds of reaching June 15th, while being able to pay all of our bills, is quite low.”

“Economists say that failure to lift the debt ceiling, and a subsequent default, would tip the economy into a recession. Moody’s Analytics predicts that a default would cost more than seven million jobs and cause the unemployment rate to move above 8%. The ratings company also predicts that the stock market would lose a fifth of its value.”

Wow.

From the plan design front, the Wall Street Journal reports

“The Internal Revenue Service on Tuesday announced the largest-ever increase to the amount Americans can set aside in health-savings accounts each year.

“For 2024, the maximum HSA contribution will be $8,300 for a family and $4,150 for an individual. That is up from $7,750 for a family and $3,850 for an individual for 2023.

“Participants age 55 and older can contribute an extra $1,000, which means an older married couple could sock away $10,300 a year, up from $9,750 this year. In the last ten years leading up to retirement, a couple could accumulate more than $100,000 in these accounts. * * *

While workers can tap 401(k)s and individual retirement accounts for medical costs, health savings accounts offer more tax savings than both traditional or Roth retirement accounts. There is no tax going in, tax-free growth and tax-free withdrawals if used for eligible healthcare expenses.”

The FEHBlog came to love the high-deductible health plan/health savings account arrangement. The Wall Street Journal endorses the FEHBlog’s viewpoint. The FEHBlog was cut off from the arrangement when he became Medicare primary in late 2019. Because the FEHBlog’s law firm has less than 20 employees, the FEHBlog found it necessary to drop his employer-sponsored coverage in favor of Medicare. Medicare coverage has been fine, but the FEHBlog misses contributing to his HSA. Younger employees should give the HDHP / HSA arrangement a close look.

The Wall Street Journal adds

“Remember one important caveat, however: If you’re sure to spend over the deductible, other plans may be more appropriate for you, such as the PPO plan that will cost you an additional $800. (You forgo the ability to save, but you also face a lower out-of-pocket maximum.) For instance, if you know with reasonable certainty that you need access to a more-expensive provider for a one-time procedure, then you should pick a plan that gives you this access, such as a PPO plan, and switch back to an HMO plan with an HDHP-and-HSA option during next year’s open-enrollment period.

“If you do end up choosing an HDHP, please remember: Do not cut back on care haphazardly, as many people do. Following a doctor’s recommendations is much more important than saving a bit of money.”

While the FEHBlog is not yet retired, he is intrigued by the Fortune Well article on cognitive decline following retirement. The article offers four ways to avoid this otherwise “universal trend.”

  1. Keep or get connected.
  2. Keep active.
  3. Keep stress to a minimum
  4. Keep working, regardless of pay.

Next stop, Walmart greeter??

From the U.S. healthcare business front, Healthcare Dive tells us

“Physician staffing firm Envision Healthcare has filed for Chapter 11 bankruptcy, citing its $7.7 billion in debt obligations, declining patient volumes, “flawed” implementation of the No Surprises Act and exclusionary health insurers as reasons for its financial decline in a restructuring announcement on Monday.

“The bankruptcy wipes out private equity firm KKR’s investment in Envision. In 2018, the PE firm shelled out over $5 billion in 2018 to take Envision private in a deal valued at $9.9 billion, including debt. Last week, The Wall Street Journal reported that an Envision bankruptcy filing would be one of the steepest losses in KKR’s history.”

From the miscellany department, NPR Shots offers articles evaluating experimental cancer treatments and looking into a new NIH study:

There’s plenty of one-size-fits-all nutrition advice. But there’s mounting evidence that people respond differently to food, given differences in biology, lifestyle and gut microbiome.

“The National Institutes of Health wants to learn more about these individual responses through a Nutrition for Precision Health study, and this week researchers began enrolling participants to take part in the study at 14 sites across the U.S.

“It’s part of the All of Us research initiative that aims to use data from a million participants to understand how differences in our biology, lifestyle and environment can affect our health.

“Holly Nicastro of the NIH Office of Nutrition Research says the goal of the precision nutrition study is to help develop tailored approaches for people. “We’ll use machine learning and artificial intelligence to develop algorithms that can predict how individuals will respond to a given food or dietary pattern,” Nicastro says.

“The study will take into account a person’s genetics, gut microbes, and other lifestyle, environmental and social factors “to help each individual develop eating recommendations that improve overall health,” Nicastro says.”

Friday Factoids

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

From Washington, DC. Roll Call informs us,

“Top negotiators for President Joe Biden and Speaker Kevin McCarthy resumed talks Friday evening to lift the nation’s borrowing cap, ending a “pause” put in place hours earlier when Republicans expressed frustration with the White House position.

“After a nearly daylong setback, White House Counselor Steve Ricchetti, White House budget director Shalanda Young, Rep. Garret Graves, R-La., and House Financial Services Chairman Patrick T. McHenry, R-N.C., resumed talks at the Capitol shortly after 6 p.m.”

From the public health front —

  • Reuters reports
    • “The U.S. Centers for Disease Control and Prevention is urging people at high risk of mpox to get two doses of Bavarian Nordic’s (BAVA.CO) Jynneos vaccine, based on new evidence from a U.S. study showing that the regimen is more effective at preventing infection than one shot.
    • “The study, published on Thursday, offered some of the first evidence on the efficacy of the Jynneos vaccine, which was deployed last year during a global outbreak of mpox that affected more than 30,000 people in the United States.”
  • and
    • “A World Health Organization (WHO) advisory group on Thursday recommended that this year’s COVID-19 booster shots be updated to target one of the currently dominant XBB variants.
    • “New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered.
    • “The group suggested no longer including the original COVID-19 strain in future vaccines, based on data that the original virus no longer circulates in human beings and shots targeting the strain produce “undetectable or very low levels of neutralizing antibodies” against currently circulating variants.
    • “COVID-19 vaccine makers like Pfizer/BioNtech (PFE.N), , Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating strains.
    • “The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected.”
  • CNBC reports
    • “NIH is enrolling patients in an early-stage clinical trial to test a universal flu vaccine based on mRNA technology.
    • “The technology is behind Moderna’s and Pfizer’s widely used Covid vaccines.
    • “Scientists hope the vaccine will protect against a wide variety of flu strains and provide long-term immunity so people do not have to receive a shot every year.” 
  • Health Payer Intelligence reminds us that the Affordable Care Act requires health plans to cover four categories of preventive services without cost-sharing when delivered in-network, not just U.S. Preventive Services Task Force Grades A and B recommendations. In addition,
    • “(1) Payers have to cover routine immunizations per the recommendations of the Advisory Committee on Immunization Practices (ACIP), a federal immunization committee. ACIP recommendations are finalized when adopted by the director of the Centers for Disease Control and Prevention (CDC). * * *
    • “(2) The ACA rules around covering preventive care services for women are based on USPSTF and ACIP recommendations. But they also consider Health Resources and Services Administration (HRSA) guidelines, which draw from the Women’s Preventive Services Initiative (WPSI) standards. To comply with the requirements of preventive care services for women, payers must fully cover well-woman visits, breastfeeding support, and screening and counseling related to intimate partner violence and other conditions and circumstances. Contraceptives approved, granted, or cleared by the Food and Drug Administration (FDA) are also covered. * * *
    • “(3) ACA preventive care coverage also encompasses services for children. These requirements are based on HRSA’s Bright Futures Project. They include well-child visits, immunizations, screenings, behavioral and developmental assessments, and more. As of May 2023, the immunization list covered conditions including but not limited to HPV, hepatitis A and B, rubella, influenza, and tetanus.” * * *
  • The Department of Health and Human Services “and the non-profit organization Baby2Baby announced a new pilot program to distribute a one-time only Newborn Supply Kit made up of essential goods and critical maternal health items to new mothers and their infants. * * * HS and Baby2Baby will first distribute 3,000 of the Newborn Supply Kits across Arkansas, Louisiana, and New Mexico – three states experiencing deep levels of family poverty – via hospitals and community-based partner organizations. Any mother giving birth during pilot implementation at one of the partner sites will be eligible to receive a kit. * * * HHS also launched a new website, www.hhs.gov/newbaby, that includes information across all Federal agencies for families on health, feeding, sleeping, child development and programmatic information.”

From the FDA front —

  • Biopharma Dive tells us
    • “A panel of Food and Drug Administration advisers on Thursday backed maternal use of Pfizer’s RSV vaccine for protecting young infants, but recommended its early use be closely monitored to confirm study safety data.
    • “The panel of outside advisers voted 14-0 that Pfizer’s vaccine, called Abrysvo, was effective in protecting infants from infections caused by respiratory syncytial virus, or RSV, when given to their mothers during pregnancy.
    • “Despite some concerns around the shot’s potential risk, they agreed in a 10-4 vote that Pfizer’s data showed it to be generally safe. The FDA, which usually follows the advice of its advisers, is expected to decide whether to approve maternal use of the shot by August. Separately, its use in older adults is due for a decision this month.”
  • MedCity News relates
    • “The inflammatory bowel disorder Crohn’s disease can be treated by several different biologic drugs administered as injections or infusions. The FDA just approved the first daily pill for the chronic condition.
    • “Rinvoq, a blockbuster AbbVie drug already approved for multiple autoimmune and inflammatory disorders, is now approved as a treatment for moderately to severely active Crohn’s disease. The decision announced Thursday specifically covers the treatment of adults whose disease has not been adequately managed by tumor necrosis factors inhibitors, a class of biologic drugs currently used to treat the disorder.”
  • “Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.”

From the Rx coverage front

  • Healio tells us,
    • “Of adolescents with obesity receiving semaglutide in the STEP TEENS trial, 44.9% improved to overweight or normal weight.
    • “The odds of improving body mass index category with semaglutide were 23 times higher than placebo.”
  • STAT News adds.
    • Novo Nordisk is pausing ads for its obesity drug Wegovy as it struggles to keep up with surging demand, the latest hurdle in its rollout of the weight loss drug.
    • “To avoid stimulating further demand for this medicine, we’re pausing some key Wegovy promotional efforts,” the Danish drugmaker said in an emailed statement. “We are pausing all local television advertising and postponing planned national television advertising for Wegovy. We are also assessing our promotional efforts to healthcare professionals and adjusting accordingly.” The news was earlier reported by Endpoints.
  • Medscape informs us,
    • “Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.
    • “The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” said Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”
    • “As of earlier this month, there were 15 oncology drugs on the official US Food and Drug Administration (FDA) drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.” * * *
    • “Drug shortages in the United States have been a chronic problem for more than two decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.”

From the U.S. healthcare business front —

  • MedCity News points out,
    • “If you enter a drugstore in any major American city, there’s a good chance you might see a retail health clinic. In the past decade or so, healthcare stakeholders have gone back and forth as to whether these clinics will have a significant impact on healthcare delivery in the U.S. But a new report reveals that retail clinics are solidifying their position as a major force in the U.S. healthcare system.
    • “Retail clinic claims volumes have shot up by 200% in the past five years, according to the report, which was released Thursday by analytics company Definitive Healthcare. 
    • Claims growth for these clinics, which are usually located in stores like Walmart, CVS and Walgreens, have greatly outpaced growth in claims for urgent care centers, emergency departments and physician practices. Urgent care center claims grew by 70% in the past five years. Meanwhile, emergency room usage dropped by 1%, and primary care office claims declined by 13%.
    • As of this year, there are more than 1,800 active retail clinics across 44 states. Most of these are in major metropolitan areas, with just 2% of clinics located in rural areas. The report argued that this paucity stems from the same factors that have produced care deserts in rural America — mainly low population density and difficulty attracting workers.
    • The report also revealed that about half of all retail clinics are concentrated in the following seven highly populated states: California, Georgia, Illinois, Florida, Ohio, Tennessee and Texas.

Thursday Miscellany

David Ermer–Congress, End of the PHE, NE, FDA, Medical / Rx research, OPM, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC, Roll Call reports

“Lawmakers from both parties suggested negotiators were making progress Thursday toward a bipartisan deal that would raise the $31.4 trillion debt limit, though days of talks still lie ahead.

“Scrambling to avert a debt limit breach that Treasury Secretary Janet L. Yellen said could hit as early as June 1, negotiators are attempting to reach a framework for a deal by Sunday, when President Joe Biden returns from a trip to the G-7 summit in Japan.

“Speaker Kevin McCarthy, who is negotiating with Biden through proxies, said he is hopeful that a deal could come as soon as this weekend. In a sign of progress, the two parties have begun to exchange offers, said House Rules Chairman Tom Cole, R-Okla.

“We’ve made good progress this week, but the work continues,” said Senate Majority Leader Charles E. Schumer. “ No one will get everything they want.”

“If a deal is reached by Monday, the House would vote next week, with 72 hours notice after the text is posted. While the Senate is scheduled to be in recess next week, Schumer said his chamber would be prepared to reconvene with 24 hours’ notice to schedule a vote.”

Per STAT News

“Pharmacy benefit managers would be subject to new transparency rules under a bill that cleared a key House subcommittee, Modern Healthcare says. The Transparent PRICE Act of 2023, which received a unanimous vote in the House Energy and Commerce Committee’s Health Subcommittee, would require pharmacy benefit managers to annually provide employers with detailed data on drug spending, including acquisition costs, out-of-pocket spending, formulary-placement rationale, and aggregate rebate information. The bill also would order the Government Accountability Office to report on group health plan pharmacy networks, including those owned by health insurers.”

Fierce Healthcare discusses other healthcare actions taken by this subcommittee yesterday.

BioPharma Dive tells us

“The U.S. Supreme Court on Thursday ruled against Amgen in its decade-long battle with Sanofi and Regeneron, affirming a lower court’s decision that Amgen’s rivals did not infringe on patents the biotechnology company held on a cholesterol-lowering medicine.

“In a unanimous decision authored by Justice Neil Gorsuch, the court said two Amgen patents on its PCSK9 inhibitor Repatha fell short of a legal standard known as enablement, which requires the claimed invention be described well enough to allow a skilled person in the field to use it. * * *

“The court’s ruling could open the door for challenges to older classes of antibody therapies, [University of Illinois law professor Jacob]Sherkow said. “This decision is probably going to give challengers solace. They’re going to have good options when working with the enablement requirements to challenge competitors’ patents out there.”

From the public health front —

  • The Robert Wood Johnson Foundation released its 2023 U.S. county health rankings while the UnitedHealthFoundation issued its 2023 Seniors Report from its America’s Health Rankings Services.
  • MedPage Today informs us
    • “The CDC encouraged populations at risk of contracting mpox, formerly known as monkeypox, to get fully vaccinated against the disease as part of preparations for summer during a briefing Thursday morning.
    • “Demetre Daskalakis, MD, the White House National Mpox Response Deputy Coordinator, noted that with summer gatherings on the horizon, mpox vaccination should be considered, as should overall sexual health and wellness.
    • “Getting ‘summer ready’ means mpox vaccination, but that’s not all it means — it also means to be up to date on all of your sexual health, and that includes HIV and STIs [sexually transmitted infections] like syphilis, gonorrhea, and chlamydia,” he said.”
  • The Department of Health and Human Services posted a fact sheet with “Resources on Ways Communities Can Stay Protected from Mpox in Advance of Summer Months.”
  • The Wall Street Journal points out the important medical tests that Americans should consider undergoing over the decades of life.
  • The U.S. Preventive Services Task Force notified the public about a draft research plan concerning “Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Interventions” that is open for comment until June 14, 2023.

From the Food and Drug Administration front, the Wall Street Journal reports

“The Food and Drug Administration for the first time cleared a test to gauge a mother’s risk of severe preeclampsia, a leading cause of pregnancy-related illness and death in the U.S.  

“Thermo Fisher Scientific said Thursday that the blood test it already sells in Europe could be available in the U.S. soon. Its introduction could transform prenatal care in the U.S., doctors and maternal-health advocates said.”

Bravo.

From the U.S. healthcare business front —

  • Beckers Hospital Review notes five new details about Kaiser Permanente’s Risant Health deal.
  • Fierce Healthcare discusses provider objections to what appears to the FEHBlog to be a reasonable new prior authorization program that UnitedHealthcare is introducing. No good deed goes unpunished.

From the miscellany department —

  • STAT News relates that
    • “A multibillion-dollar science agency tasked with slashing through research bureaucracy will start its work with a plan to help people regenerate bone.
    • “The Advanced Research Projects Agency for Health, launched a little more than a year ago, announced Thursday that its first official program would target bone and joint damage from osteoarthritis, a condition affecting more than 32 million Americans.”
  • Govexec discusses FEHB coverage of Covid tests and vaccines following the end of the PHE.
  • The Equal Employment Opportunity Commission weighs in on the Title VII compliance implications of employer use of artificial intelligence to make employment decisions.