Thursday Miscellany

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington DC, where the air quality index was code red today —

  • The Supreme Court is down to its final four pending decisions from the October 2022 term. The final decision day is tomorrow morning
  • The EEOC Chair made the following noteworthy comment on today’s Supreme Court decision on affirmation action in college admissions:
    • “Today’s Supreme Court decision effectively turns away from decades of precedent and will undoubtedly hamper the efforts of some colleges and universities to ensure diverse student bodies. That’s a problem for our economy because businesses often rely on colleges and universities to provide a diverse pipeline of talent for recruitment and hiring.  Diversity helps companies attract top talent, sparks innovation, improves employee satisfaction, and enables companies to better serve their customers”.
    • “However, the decision in Students for Fair Admissions, Inc. v. President & Fellows of Harvard College and Students for Fair Admissions, Inc. v. University of North Carolina does not address employer efforts to foster diverse and inclusive workforces or to engage the talents of all qualified workers, regardless of their background. It remains lawful for employers to implement diversity, equity, inclusion, and accessibility programs that seek to ensure workers of all backgrounds are afforded equal opportunity in the workplace.”
  • Govexec tells us
    • “The Supreme Court on Thursday ruled against the U.S. Postal Service in its attempts to require any employee to work on Sundays, even when it conflicted with their religious observances. 
    • “In a unanimous decision [interpreting Title VII of the Civil Rights Act of 1964], the top court reversed decades of precedent in determining that employers like USPS have to demonstrate more than a de minimis burden to avoid their otherwise mandated obligations to provide reasonable religious accommodations. The justices sent the case back to a lower court to determine whether, given the specifics of the case, the Postal Service could come up with other means to keep a letter carrier on the payroll without requiring him to work on Sundays.”

From the public health front —

  • The American Hospital Association informs us
    • “As proposed by its Advisory Committee on Immunization Practices, the Centers for Disease Control and Prevention [(CDC)] today recommended a single dose of the GSK or Pfizer Respiratory Syncytial Virus vaccine for people aged 60 and older who decide with their health care provider that the vaccine would benefit them. The Food and Drug Administration last month approved the vaccines for use in individuals 60 and older. The first U.S.-licensed vaccines to protect against RSV, they are expected to be available this fall.”
  • The CDC announced
    • “CDC Director Rochelle P. Walensky, M.D., M.P.H. adopted the 2023-2024 Advisory Committee on Immunization Practices’ (ACIP) recommendations on annual influenza (flu) vaccination for everyone 6 months and older in the United States on June 27, 2023.  There were small changes to the annual recommendations around flu vaccination, including an acknowledgement of the updated flu vaccine composition for the 2023-2024 flu season and a change in the recommendations for vaccination of people with egg allergies. Dr. Walensky’s adoption of the ACIP recommendations makes them official CDC policy. * * *
    • The recommended timing of flu vaccination has not changed. September and October are the best times for most people to get vaccinated.
  • The Department of Health and Human Services announced
    • “[Its] Office of the Assistant Secretary for Health (OASH) is releasing a draft framework to support and accelerate smoking cessation, building on supports that are already in place for people who want to quit. This framework will be a roadmap to enhance collaboration and coordination across HHS—and with federal and nonfederal stakeholders—to drive further progress toward smoking cessation and to deliver equitable outcomes for all persons in America. HHS is seeking public input on the framework before it is finalized.
    • “The public comment period will be open for 30 days starting June 30, 2023, through July 30 at 11:59 PM ET. HHS is committed to transparency and providing opportunities for public participation during the development of the Framework.
    • “Anyone can comment. Each responding entity (person or organization) is requested to submit only one response via email to HHSSmokingCessationFramework2023@hhs.gov as a Word document, Portable Document Format (PDF), or in the body of an email. Please include “Request for Information: Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation” in the subject line of the email message.”
  • The Society for Human Resource Management offers employers strategies for reducing record-level employee stress.
  • Roll Call reports
    • “Only one-third of individuals diagnosed with hepatitis C have been cured in the decade since cures for the disease became available, according to a study published Thursday from the Centers for Disease Control and Prevention.
    • “Hepatitis C is a viral inflammation of the liver that can be asymptomatic yet spread through blood or other bodily fluids. Without treatment, hepatitis C is a chronic condition that can lead to liver cancer, liver failure or other comorbidities. 
    • “The Food and Drug Administration approved the first highly effective direct-acting antiviral drugs to cure hepatitis C in 2013. Treatment occurs over the course of 8 to 12 weeks and has a 95 percent success rate.
    • “But almost 15,000 Americans still die from hepatitis C annually. * * *
    • “Francis Collins, the former longtime NIH director who leads the White House National Hepatitis C Elimination Program, said the data “highlights an urgency for a bold response to hepatitis C.”

From the health plan design front

  • Fierce Healthcare discusses
    • “Following the COVID-19 pandemic, the rising tide of mental health concerns—particularly among children and adolescents—has been a major focus in the industry.
    • “But it’s not a new problem. Behavioral health needs have been on the rise for some time, and that’s why in 2018 the team at Elevance Health’s Carelon established the Suicide Prevention Program, which deploys data and predictive models to identify people at risk sooner and avoid potential self-harm or suicide events. 
    • “Suicide is the second-leading cause of death for young people, and rates have increased by 56% in the last 20 years. Through the prevention program, Carelon saw a reduction of more than 20% in suicidal events among adolescents and young adults with commercial coverage.
    • I”n addition, this corresponded to a 30% decrease in per member per month behavioral health spending.”
  • The Society for Human Resource Management identifies four ways to boost employee satisfaction with high deductible plans connected with health savings accounts.

From the generative AI front,

  • Beckers Hospital Review notes,
    • “Johnson City, Tenn.-based Ballad Health is using artificial intelligence to identify potential medication errors and improve pharmacy workflows, the health system said June 29. 
    • “Ballad is using a medication safety monitoring platform from MedAware for this effort. The platform monitors drug prescriptions in real-time and compares this information against patient data from the health system’s EHR to flag potentially dangerous or fatal drug interactions. 
    • “The Ballad Health Innovation Center and Ballad Ventures, the system’s venture capital subsidiary, is funding the project with MedAware.

From the healthcare spending front —

  • Healthcare Dive relates
    • “Healthcare costs are expected to rise 7% next year as inflation drives providers to seek rate increases from insurers and pharmaceutical costs rise, according to PwC’s annual report.
    • “The consultancy, which surveyed actuaries at insurers that offer group and individual plans, said the increase outstrips its predictions for 2022 and 2023, which were 5.5% and 6% respectively.
    • “Some trends are pushing costs down, like the availability of more biosimilar drugs and a shift toward cheaper outpatient care. A number of other factors are expected to be cost neutral but key to watch, including health plans’ investment in value-based care, COVID-19 impacts, behavioral healthcare utilization, health equity initiatives, price transparency rules and Medicaid redeterminations, PwC said.
  • and
    • “Primary care physicians saw their compensation rise faster than other medical and surgical specialties in 2022, as significant E/M coding changes enacted by the CMS kicked into gear and volume stabilized coming out of the pandemic.
    • “Medical groups and healthcare organizations reported a 6.1% increase in primary care compensation in 2022 compared to 2021 in the AMGA’s most recent compensation survey published on Wednesday. That’s compared to 1.5% and 1.6% increases for medical and surgical specialties, respectively.
    • “Medical groups’ revenue increased faster than compensation gains for physicians, a trend the AMGA said could be due to groups using more revenue to address higher expenses as supply and labor costs soared.”
  • Health Payer Intelligence points out
    • “Individuals with depression, anxiety, or both who are enrolled in large employer-sponsored health plans have higher out-of-pocket spending than individuals without such diagnoses, according to an issue brief from the Peterson-KFF Health System Tracker.
    • “These findings of higher health spending among privately insured individuals receiving treatment for depression and/or anxiety come at a time of rising health costs. Health insurance is already expensive for enrollees with private insurance, and treatment for mental health conditions can further escalate these costs,” the brief noted.
    • “The researchers used large employer health plan claims from the 2021 MerativeMarketScan Commercial Database. Nine percent of adult, large employer-sponsored health plan enrollees had a depression or anxiety diagnosis or both.
    • “Members with a generalized anxiety disorder (anxiety) diagnosis, a depression diagnosis, or both spent, on average, $1,501 per year in out-of-pocket costs. This was nearly double the $863 in average annual out-of-pocket healthcare spending that individuals without one of these diagnoses spent.
    • “Moreover, total annual spending, including out-of-pocket healthcare costs, was 1.9 times higher for individuals with one of these diagnoses than those without one. Utilization was also twice as high for those diagnosed, who typically visited a provider’s office 7.4 times per year, while those without a diagnosis visited 3.2 times per year on average.

From the Food and Drug Administration (FDA) front —

  • The Wall Street Journal reports
    • “The promise of gene therapy has arrived for thousands of Americans with the most common and severe form of hemophilia.
    • “The U.S. Food and Drug Administration approved the first gene therapy for hemophilia A on Thursday, giving patients a long-awaited option for avoiding the burden of regular infusions and injections.
    • “That’s a complete game-changer for quality of life,” said Mike Reutershan, a 38-year-old medicinal chemist with hemophilia who lives in suburban Boston. “You don’t have to carry a bag of medicine around with you.” 
    • “The FDA approved the new gene therapy, called Roctavian and made by BioMarin Pharmaceutical, for adults with a severe form of the disease. Roctavian is infused just once.  
    • “Priced at $2.9 million, the drug now ranks among the most expensive in the world. But the price is in line with the cost of other new gene therapies, a groundbreaking type of treatment that replaces a missing or faulty gene.”
  • Cardiovascular Business informs us
    • “Just eight days after approving the first anti-inflammatory drug for cardiovascular disease, the U.S. Food and Drug Administration (FDA) has made another historic approval focused on cardiovascular health. 
    • “The agency announced Wednesday, June 29, that it has approved donislecel, a new pancreatic islet cellular therapy made from the pancreatic cells of deceased donors, for the treatment of type 1 diabetes among adult patients with severe hypoglycemia. Donislecel is marketed and sold by Chicago-based CellTrans under the brand name Lantidra
    • “This represents the first time the FDA has approved a cellular therapy for type 1 diabetes.”
  • Biopharma Dive calls attention to ten clinical trials to watch in the second half of this year.  

 

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The U.S. Supreme Court released three more opinions this morning. The Wall Street Journal reports
    • “The Supreme Court rejected a bid by Norfolk Southern to limit its state-court liability in states where it does relatively little business, ruling Tuesday that states can require companies to submit to their courts’ jurisdiction as a condition of doing business within their borders.
    • “While the case involved a long-pending workplace lawsuit filed by a retired railway employee from Virginia, Justice Neil Gorsuch, writing for a 5-4 majority of the justices, linked the issue to a Norfolk Southern train’s Feb. 3 derailment in East Palestine, Ohio.”
  • The Supreme Court has pending seven more decisions from its October 2022 term. The next decision day will be Thursday morning.
  • Beckers Hospital Review tells us,
    • “The Federal Trade Commission has proposed changes to the premerger notification form in addition to premerger notification rules implementing the Hart-Scott-Rodino Act, which requires organizations to report large transactions to the FTC and Justice Department for antitrust review.
    • “The HSR Act and its implementing rules related to mergers and acquisitions involve completing HSR Forms and waiting a specified period of time before completing the transaction.
    • “The proposed HSR changes would help the agencies to more effectively screen transactions for potential competition issues within the waiting period, which is generally 30 days. The FTC said that this competition review is important to identify deals that require in-depth investigations to determine whether they would violate antitrust laws and, if so, to seek to block the proposed transaction.”
  • HHS Inspector General announced posting
    • “its final rule implementing information blocking penalties. The final rule establishes the statutory penalties created by the 21st Century Cures Act. If OIG determines that an individual or entity has committed information blocking, they may be subject up to a $1 million penalty per violation.
    • “The final rule does not impose new information blocking requirements. OIG incorporated regulations published by the Office of the National Coordinator for Health Information Technology (ONC) as the basis for enforcing information blocking penalties. For more information on ONC’s information blocking regulations see: Information Blocking.
    • “To report complaints about information blocking, please visit the ONC Information Blocking Portal or the OIG Hotline.”
  • HR Dive points out the steps that covered employers to take to comply with the Pregnant Workers Fairness Act, which took effect today.

From the public health front —

  • The Washington Post reports,
    • “For the first time in two decades, malaria infections have been confirmed in people who did not travel outside the United States, leading federal health authorities to warn about the potential for transmission of the mosquito-born disease within the nation’s borders.
    • “Four people in Sarasota County, Fla., and one in Cameron County, Tex., were confirmed as having been infected between late May and late June through local transmission. All have gotten treatment and are recovering as health officials watch for additional cases, the Centers for Disease Control and Prevention said.
    • “Although the potentially fatal disease was once endemic, it was declared eliminated in the United States in 1951. About 2,000 people are diagnosed with malaria in the nation each year, but those cases have involved trips abroad. For a handful who came down with the disease in recent months, that was not the case.
    • “The risk of getting malaria in the United States “remains extremely low,” the CDC said. Still, experts said Americans should be aware of the possibility and take steps to prevent mosquito bites.”
  • The CDC discusses a recent study examining the health impact of widening the age range eligible for cost-free in-network diabetes type 2 testing.
  • The Health and Human Services Department “releasedreport showcasing evidence-based interventions to support physical activity among adults ages 65 years and older. By the year 2030, 1 in every 5 Americans will be age 65 or over. More than 85 percent of older adults currently have at least 1 chronic health condition. The growing population of older adults can gain substantial health benefits and prevent or manage chronic disease by engaging in physical activity.”

From the Rx coverage front —

  • Health Affairs lets us know that
    • “Using Medicare claims, we documented US prescribing patterns for originator biologic trastuzumab (Herceptin), a targeted cancer therapy, and five biosimilar entrants since 2019. The first biosimilar captured a dominant share, but over time, average sales prices of all products declined, and later entrants became dominant in some states. Despite strong brand loyalty to the first biosimilar, competitive pressure increased with subsequent entrants.”
  • Beckers Hospital Review relates
    • “With about a dozen cancer drugs on back order and no clear end to the shortages, the American Society of Clinical Oncology and the Society of Gynecologic Oncology recently advised clinicians to ration chemotherapy supplies. 
    • “The updated guidelines recommend curbing or halting pharmaceutical treatment for patients with “recurrent, agent-resistant cancers” — which means saving therapies for patients with a better chance of surviving. 
    • “The national cancer care group also recommended extending the time between treatments when appropriate; lessening waste by “optimizing vial size, dose rounding and using multi-use vials”; and providing support services to patients and clinicians experiencing “shortage-related distress.”
    • “Two cancer drugs in shortage that treat multiple cancers and cost about $20 per vial, cisplatin and carboplatin, have been in shortage for months. One of the main suppliers for the drugs ended operations in late 2022 after FDA investigators found numerous quality infractions and ruined reporting documents. In another inspection, the agency found more quality issues, which could further delay expected recovery. 
    • “The FDA allowed a China-based drug company to produce and import cisplatin, and the agency is working to boost carboplatin supplies.”

From the studies front —

  • The National Institutes of Health announced
    • “In people with Alzheimer’s disease, the underlying changes in the brain associated with dementia typically begin many years—or even decades—before a diagnosis. While pinpointing the exact causes of Alzheimer’s remains a major research challenge, they likely involve a combination of genetic, environmental, and lifestyle factors. Now an NIH-funded study elucidates the role of another likely culprit that you may not have considered: the human gut microbiome, the trillions of diverse bacteria and other microbes that live primarily in our intestines.
    • “Earlier studies had showed that the gut microbiomes of people with symptomatic Alzheimer’s disease differ from those of healthy people with normal cognition [2]. What this new work advances is that these differences arise early on in people who will develop Alzheimer’s, even before any obvious symptoms appear.
    • “The science still has a ways to go before we’ll know if specific dietary changes can alter the gut microbiome and modify its influence on the brain in the right ways. But what’s exciting about this finding is it raises the possibility that doctors one day could test a patient’s stool sample to determine if what’s present from their gut microbiome correlates with greater early risk for Alzheimer’s dementia. Such a test would help doctors detect Alzheimer’s earlier and intervene sooner to slow or ideally even halt its advance.”
  • Fierce Healthcare informs us
    • “Medicare Advantage (MA) beneficiaries given home-delivered meals in the four weeks after being discharged from a hospital were not only less likely to be readmitted within 30 days, they were also less likely to die, according to a study in JAMA Health Forum.
    • “The 2018 Chronic Care Act gave MA plans greater leverage to address the social determinants of healthcare. In addition to giving insurers an impetus for launching dietary programs, the act also covers transportation for beneficiaries and other at-home services.
    • “The study states that “nearly three-quarters of MA plans offered meals as a supplemental benefit in 2022, mostly driven by expectations of downstream cost savings based on findings from earlier observational studies of community-based nutrition programs, and desires to maintain market parity in an increasingly competitive MA space.
    • “Beginning in January 2021, Kaiser Permanente Southern California (KPSC) began offering home-delivered meals to eligible MA enrollees. The comparative cohort study in JAMA Health Forum examines data from 4,032 KPSC MA enrollees who’d been hospitalized for heart failure and 7,944 who’d been hospitalized for other reasons after they’d been discharged from Jan. 1, 2021, to Jan. 31, 2022. The data come from 15 hospitals in the KPSC network.”

In U.S. healthcare business news —

  • Healthcare Dive reports
    • “Walgreens missed Wall Street earnings expectations in its third fiscal quarter and cut its 2023 outlook, citing macro factors including a weak respiratory season and falling demand for COVID-19 tests and vaccines.
    • “The pharmacy chain did beat the Street’s revenue expectations with a topline of $35.4 billion, up 9% year over year, thanks in part to its expanding U.S. Healthcare segment, which includes value-based medical group VillageMD.”

Midweek update

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.”

Happy Memorial Day

Today we honor our service members who died for our Country. While many of my forebearers served, it was the son of one of the FEHBlog’s first cousins, Army Capt. Eric T. Paliwoda, who died in combat. Next January 2 will mark the 20th anniversary of his death in Iraq. Rest in peace. Never forget.

The Senate is in session this week for floor voting and Committee business, while the House of Representatives, which had planned to take a District work break, will resume floor voting and hold a Rules Committee meeting tomorrow.

The Wall Street Journal reports

  • “The path to a tentative agreement to raise the debt limit started in January with the election of Kevin McCarthy as House speaker on the 15th ballot, after he made conservatives a host of promises to cut spending and gave them the ability to oust him if he wavered.
  • “It ended with President Biden caving from his pledge not to negotiate and the two sides crafting an accord that neither the right nor left wanted, which places new limits on spending for two years and raises the nation’s borrowing limit for the same period. 
  • “The agreement represents a compromise, which means not everyone gets what they want,” Biden said. “That’s the responsibility of governing.” McCarthy called the deal an “agreement in principle” and warned: “We still have a lot of work to do.”

The agreement has been reduced to legislative language that the House of Representatives will consider on Wednesday. Roll Call describes the deal in English. The Senate is expected to take up the bill on Friday if all goes well. The FEHBlog at least expects it will.

From the miscellany department —

  • Last week, the Centers for Medicare and Medicaid Services proposed a rule to improve prescription drug price transparency in Medicaid.
  • The Wall Street Journal explains why “Early detection of dementia can help people make important decisions and weigh possible treatments. But getting a diagnosis can be difficult.”
    • “Getting an early and correct diagnosis for dementia gives those with the condition time to make financial and legal plans while they still can. A timely diagnosis could become even more important with new drugs, such as Biogenand Eisai’s Leqembi and Eli Lilly’s donanemab that help slow decline in early stages of Alzheimer’s. The drugs wouldn’t be used to treat frontotemporal dementia, or FTD, but they hold promise for future treatments across a broader spectrum of dementia.” * * *
    • “Yet, dementia remains difficult to diagnose. About half of those affected go undiagnosed, according to studies on dementia diagnosis and prevalence. 
    • “Doctors who specialize in dementia cite several reasons for high undiagnosed rates, including a shortage of specialists such as cognitive neurologists, geriatric psychiatrists and gerontologists, and limited access to tests, including certain PET scans that help reveal specific abnormalities in the brain but may not be covered by insurance. Blood tests to detect Alzheimer’s risk aren’t widely used.  
    • “Many individuals, family members and primary-care doctors are reluctant to talk about dementia because they are afraid, embarrassed or think nothing can be done. Early symptoms are often attributed to stress, lack of sleep and forgetfulness.”
  • NPR Shots reports on the “intriguing” results of a study of multivitamin use by older Americans.
  • Fortune Well tells us
    • Symptoms of prostate cancer [the second deadliest cancer in the U.S.] can vary widely, and some patients don’t show symptoms at all, according to the U.S. Centers for Disease Control and Prevention. The following symptoms, however, may be telltale signs:
      • Difficulty beginning to urinate
      • Weak urine flow, or interrupted flow
      • Frequent urination
      • Trouble fully emptying bladder
      • Pain or burning while urinating
      • Blood or semen in urine
      • Back, hip, and/or pelvis pain that doesn’t go away
      • Painful ejaculation
    • Patients diagnosed in early stages of the condition can have a “high expectation of cure,” Knudsen says, and “can continue to have a wonderful quality of life.” In fact, the five-year survival rate for prostate cancer detected early is virtually 100%, Siddiqui says.
    • The outlook for late-diagnosed patients, however, is not nearly as rosy. There is no “durable cure” for such cancer, Knudsen points out. The five-year survival rate for advanced prostate cancer is only 31%, according to Siddiqui.
    • When it comes to prostate cancer prevention, “what’s good for your heart is good for your prostate,” Oh advises. He encourages men to pack their diets full of leafy green veggies and colorful fruits, and to limit dairy and barbecued meat, which are associated with a higher risk of prostate cancer and aggressive prostate cancer.

Tuesday’s Tidbits

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.”

Midweek update

Photo by Manasvita S on Unsplash

From Washington DC, Roll Call informs us,

“Negotiators tapped by President Joe Biden and Speaker Kevin McCarthy to hash out a debt limit compromise were racing against the clock Wednesday to get some principles down on paper that could be written into legislative text in time for votes as early as next week.

“Both the president and his chief GOP counterpart on Capitol Hill said they thought a deal was possible. Biden is scheduled to return Sunday from his trip to Japan for the G-7 summit, telling reporters at the White House on Wednesday he’d be back for “final negotiations” and that he’d hold a press conference upon his return.

“I’m confident that we will get the agreement on the budget, that America will not default,” Biden said. “Every leader in the room understands the consequences if we fail to pay our bills.”

The FEHBlog offers less encouraging news from the public health front —

  • The Wall Street Journal reports
    • “For decades, advances in healthcare and safety steadily drove down death rates among American children. In an alarming reversal, rates have now risen to the highest level in nearly 15 years, particularly driven by homicidesdrug overdoses, car accidents and suicides.
    • “The uptick among younger Americans accelerated in 2020. Though Covid-19 itself wasn’t a major cause of death for young people, researchers say social disruption caused by the pandemic exacerbated public-health problems, including worsening anxiety and depression. Greater access to firearms, dangerous driving and more lethal narcotics also helped push up death rates.
    • “Between 2019 and 2020, the overall mortality rate for ages 1 to 19 rose by 10.7%, and increased by an additional 8.3% the following year, according to an analysis of federal death statistics led by Steven Woolf, director emeritus of the Center on Society and Health at Virginia Commonwealth University, published in JAMA in March. That’s the highest increase for two consecutive years in the half-century that the government has publicly tracked such figures, according to Woolf’s analysis. * * *
    • “Many public-health experts say they don’t think the end of the pandemic will reverse the rise in death rates among young people. Rivara predicts these problems will continue due to persistent issues around mental health and the accessibility of guns.
    • “[Dr. Elizabeth] Wolf said demand for child and adolescent psychiatric services still outstrips supply in her Richmond, Va., office. Patients are on months long waiting lists to see a psychiatrist that accepts insurance.”  
  • Digging deeper, the Journal informs us,
    • “Overdose deaths in the U.S. edged higher in 2022, a federal estimate showed, marking only the second time drugs killed more than 100,000 people in a year. 
    • “The Centers for Disease Control and Prevention on Wednesday released a provisional count of overdose deaths last year that indicated the toll of the fentanyl crisis leveling off after two years of surges during the Covid-19 pandemic. The CDC counted 109,680 overdose deaths in 2022 compared with 109,179 deaths from a similar 2021 projection. For overdose deaths to hover at such a high level demonstrates how fentanyl’s ubiquity and potency continue to threaten the lives of illicit drug users. 
    • “I’m glad to see us not get worse, but it’s hard to celebrate,” said Dr. Chad Brummett, an anesthesiologist and co-director of the Opioid Research Institute at the University of Michigan.”
  • STAT News adds
    • “More than a quarter of American adults are depressed, a 10% surge from nearly a decade ago, according to the latest Gallup survey.
    • “The data come as the Biden administration tries to overhaul mental health care costs and boost the number of health care workers licensed to practice behavioral health care. Congress in this year’s budget also allotted hundreds of millions of dollars to mental health care grants and programs, many of them trained on children or substance misuse.”
  • On a related note
    • McKinsey Consulting explores how virtual hospitals could offer respites to overwhelmed health systems.
    • Health Affairs Forefront discusses approaches to integrating behavioral health with primary care.
    • Employee Benefits News identifies three coverage categories that can reduce healthcare disparities and lower costs — 1) Colon cancer screening (Hey OPM, the article suggests giving a free day off to employees who undergo screening colonoscopies); 2) Basic dental care, and 3) fertility coverage.

From the Rx coverage front, the New York Times reports,

“Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels.

“Hospitals are scouring shelves for supplies of a drug that reverses lead poisoning and for a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce following the winter flu season when doctors and patients frantically chased medicines for ailments like strep throat. Even children’s Tylenol was hard to find.

“Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns.

“The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying causes of the faltering generic drug market, which accounts for about 90 percent of domestic prescriptions.”

No bueno.

From the human resources front, HR Dive relates,

  • “Employers cannot automatically revoke reasonable accommodations related to COVID-19, despite the dissolution of the “public health emergency” status for the pandemic, the U.S. Equal Employment Opportunity Commission cautioned employers Monday. “Employers may evaluate accommodations granted during the public health emergency, and, in consultation with the employee, assess whether there continues to be a need for reasonable accommodation based on individualized circumstances,” the agency said. 
  • “The warning came as EEOC announced updates to its technical guidance, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” including additional accommodation examples and tips for preventing COVID-related harassment.
  • “The EEOC highlighted that accommodations include low-cost or free measures, such as uninterrupted work time, a quiet workspace or noise-canceling headphones to facilitate that.”

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington DC —

  • The Wall Street Journal reports
    • “Rochelle Walensky will be stepping down as director of the Centers for Disease Control and Prevention in June, the agency said Friday.
    • “Dr. Walensky decided to step aside, after more than two years in the job, as the Biden administration prepares to end the national health emergency around Covid-19 next week and just hours after the World Health Organization declared the crisis was over.
    • “Her departure is another indication the U.S. is moving into a new phase of its response to the virus, which health experts say is still a threat but not spreading like it had, and hospitalizations and deaths are nearing new lows.”
  • The Washington Post adds
    • “Neera Tanden will replace Susan Rice as head of President Biden’s Domestic Policy Council, the White House announced Friday, becoming the first Asian American to serve in the role.
    • “I am pleased to announce that Neera Tanden will continue to drive the formulation and implementation of my domestic policy, from economic mobility and racial equity to health care, immigration and education,” Biden said in a statement.
    • “Tanden, 52, has served as senior adviser and staff secretary to Biden since 2021, overseeing aspects of the president’s domestic, economic and national security teams. Tanden also held policy advising positions in the Clinton and Obama administrations, and was the former president of the Center for American Progress, a liberal think tank.”

From the public health front —

  • The Wall Street Journal informs us,
    • “The World Health Organization declared an end to the Covid-19 emergency, signaling that one of the most deadly and economically devastating pandemics in modern history is receding as the disease that caused it becomes a routine illness. 
    • Covid-19 is here to stay, but the pandemic has been in a downward trend for more than a year because people around the world have built up immunity to the virus, the WHO said on Friday. Mortality has decreased, and there is less pressure on health systems. The trends have enabled most countries to return to prepandemic life, even as Covid-19 continues to spread.
    • “It’s therefore with great hope that I declare Covid-19 over as a global health emergency,” said WHO Director-General Tedros Adhanom Ghebreyesus.
  • Here are links to the CDC’s Covid Data Tracker and Weekly Fluview which continue to support the ending of U.S. Covid public health emergency next Thursday, May 11.
  • U.S. News and World Report ranks U.S. states by mental health depression rates.
    • “Around 1 in 5 American adults have dealt with a form of depression, with data also indicating symptoms are most prevalent among young adults and women.
    • “According to the most recent survey data collected through the Behavior Risk Factor Surveillance System, which is administered by the Centers for Disease Control and Prevention, a median of about 21% of the U.S. adult population in 2021 had ever been told they have a form of depression. That’s the highest the share has been in comparative data collected since 2011.”
  • NBC News points out that
    • “Prolonged and unexplained bouts of diarrhea, stomachaches and spots of blood during bowel movements may be signs of early-onset colorectal cancer — a disease that’s increasingly found in young adults not old enough to qualify for colonoscopies.
    • “The most troubling early symptom is rectal bleeding, a possible sign of colon cancer that’s not comfortably discussed beyond the bathroom.
    • “It can be difficult or embarrassing to talk about,” said Dr. Matthew Kalady, the director of the division of colon and rectal surgery at the Ohio State University Comprehensive Cancer Center. “But the reality is everybody deals with something like this,” and it’s important to understand what’s normal and what’s not, he said.
    • “The new research from Washington University School of Medicine in St. Louis, published Thursday in the Journal of the National Cancer Institute, included 5,075 people with early-onset colorectal cancer.”

From the U.S. healthcare business front —

  • Healthcare Dive tells us,
    • “Cigna Group raised its full-year guidance for adjusted earnings per share, revenue and customer growth as it reported first-quarter results Friday, including total revenue up 6% year over year at $46.5 billion. The insurer’s net income, at $1.3 billion, increased from $1.2 billion in the year-ago period. 
    • “Cigna posted a medical loss ratio of 81.3%, down from 81.5% in the prior-year quarter and better than internal expectations. This was partly based on lower COVID-19 costs. Claims for COVID, flu and respiratory syncytial virus were lower than expected in the quarter while non-viral care needs were more normalized, executives said on a call with investors Friday. * * *
    • “In discussing pharmacy benefit management arm Express Scripts, executives said they are aware of public and political pressure to lower drug costs, but are prepared to adapt as needed. “We are confident in our ability to earn sustainable and attractive margins for our services under a variety of legislative scenarios,” [CEO David] Cordani said.”
  • Fierce Healthcare relates that
    • “Option Care Health, a provider of post-acute care and infusion services, will shell out $3.6 billion to acquire home health and hospice firm Amedisys.
    • “The deal will create a massive provider of post-acute care services encompassing more than 16,500 employees and 674 care centers in 46 U.S. states, with a projected $6.2 billion in annual revenue. The combination of the two will enable the companies to beef up capabilities and expand their footprints as care options increasingly move into patients’ homes.
    • “Combining Amedisys’ home health, hospice, palliative and high-acuity care services with Option Care Health’s home and alternate site infusion services will create a leading independent platform for home and alternate site care, according to the executives in a press release.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the public health front —

  • MedPage Today tells us
    • “COVID-19 dropped to the fourth leading cause of death in 2022, down from third place in 2020 and 2021, according to provisional mortality data from the CDC.
    • “Taking its place was “unintentional injury,” which followed heart disease and cancer as the longstanding top killers, reported Farida B. Ahmad, MPH, and colleagues in Morbidity and Mortality Weekly Report (MMWR).”
  • The New York Time reports
    • “Births and pregnancies in the United States have been on a long-term decline. A new data analysis provides one reason: It’s becoming less common for women to get pregnant when they don’t want to be.
    • “The analysis, released Thursday in the journal Demography by researchers at the Guttmacher Institute, estimates the number of pregnancies in the United States — there is no single official count — and examines women’s feelings about the timing of their pregnancies.” 
  • The New York Times Morning column points out that state legislatures are embracing harm avoidance approaches to drug addiction. ” The approach focuses on mitigating the potential dangers of drugs, not necessarily encouraging users to abstain, e.g., legalizing fentanyl testing strips.”

From the mental healthcare front —

  • The Department of Health and Human Service recognizes “this Mental Health Awareness Month, [by] bringing attention to mental health and how essential it is to overall health and wellbeing [via] a fact sheet providing a snapshot of various efforts made by HHS over the past year.
  • Per Govexec,
    • “The Office of Personnel Management encouraged agencies to highlight the variety of mental health resources available to federal employees, and highlighted a new interagency effort to connect feds with mental health-related tools and events.
    • “In a memo to agency heads marking the start of Mental Health Awareness Month, OPM Director Kiran Ahuja said protecting the physical and mental well-being of federal workers is a “top priority” for the administration.
    • “We encourage agency leaders to remind employees about the importance of cultivating healthy wellness habits, which include caring for one’s mental health on a proactive rather than reactive basis,” she wrote. “Initiating regular conversations surrounding mental and emotional well-being is instrumental in normalizing and destigmatizing receiving mental health treatment and fostering a healthier workforce.”
    • “Ahuja said a new interagency listserv called Mindful Fed will offer tools and activities that federal employees can use to maintain their mental health. * * *
    • “Federal workers seeking to join the new listserv can email Mindful-FED-subscribe-request@listserv.gsa.gov, Ahuja wrote.”

From the U.S healthcare business front —

Healthcare Dive informs us,

  • Hospital margins continued to stabilize in March, but remained razor thin as inflation drove up supply and drug costs, according to Kaufman Hall’s national hospital flash report.
  • Hospitals reported flat median year-to-date operating margins, an improvement from almost a year of negative margins, according to the report.
  • “While it appears that hospital finances are stabilizing, that doesn’t mean that all is well,” said Erik Swanson, senior vice president of Data and Analytics with Kaufman Hall, in a statement.
  • Expenses, driven by economic inflation, hampered hospitals and outpaced a 24% month-over-month increase in profitability and a 12% increase in revenue.

and

  • “U.S. telehealth use totaled 5.5% of medical claim lines in February, a drop of 6.8% from January, according to Fair Health’s monthly telehealth tracker.
  • “In February, telehealth use declined in the four U.S. census regions: It dropHelaped by 8.7% in the Midwest, 8.3% in the South, 6.2% in the West and 1.5% in the Northeast.
  • “COVID-19 dropped out of the top five telehealth diagnoses nationally. The top diagnosis on telehealth claim lines was mental health conditions.”

From the miscellany front —

  • Fierce Healthcare relates, “It’s official: Medicare Advantage (MA) enrollment accounts for just over half of all Medicare beneficiaries, according to a new analysis from the Kaiser Family Foundation.”
  • Healthcare Innovation tells us,
    • “A year ago, officials from the Center for Medicare and Medicaid Services unveiled a National Quality Strategy. In a May 1 update on the strategy, CMS officials discussed several goals, including annually increasing the percentage of digital measures used in CMS quality programs. CMS officials also said the organization would build one or more quality data systems that can receive data using the FHIR data standard by 2027.”
  • The Segal consulting firm offers a five step strategy for improving wellness programs.
  • Mercer Consulting delves into employer health benefit planning ideas for 2024.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill —

Roll Call tells us, “Senators are so far standing firm on letting Speaker Kevin McCarthy and President Joe Biden work out how to address the debt limit.” The President’s meeting with Congressional leaders will be held on May 9.

Fierce Healthcare informs us,

  • “A key Senate panel has postponed a markup hearing on several bills aimed at drug pricing until after the heads of three major drug companies and three pharmacy benefit managers appear before legislators.
  • “The Senate Health, Education, Labor and Pensions Committee convened Tuesday morning to discuss four pieces of legislation aimed at tackling the rising costs of drugs in the U.S., including a bill that would push significant reforms to the PBM industry.
  • “Instead, the committee will markup the bills on May 11, one day after hosting a blockbuster hearing on insulin and other drug pricing issues. The hearing will include testimony from Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jorgensen, Sanofi CEO Paul Hudson, CVS Health President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.”

From the public health front —

  • The National Institutes of Health announced
    • Women aged 55 years and younger have nearly double the risk of rehospitalization in the year immediately after a heart attack compared to men of similar age, according to a study supported by the National Institutes of Health. Higher rates of risk factors such as obesity, heart failure, and depression among women most likely contributed to the disparity.
    • “The findings suggest a need for closer health monitoring of the approximately 40,000 American women aged 18 to 55 years who have heart attacks each year following hospital discharge, and a better understanding of the reasons behind the different outcomes. The study, funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, was published today in the Journal of the American College of Cardiology.”
  • The U.S. Preventive Services Task Force updated its recommendation for screeening asymptomatic adults at increased risk of latent tuberculosis infection (LTBI) with the same grade B that it last gave in 2017. The FEHBlog is impressed by the USPSTF’s routine re-evaluation of its decisions.
  • The Department of Health and Human Services announced
    • “awarding the 15 winners for Phase 1 of the HHS Endocrine-Disrupting Chemicals (EDC) Innovator Award Competition. This competition was developed to identify gaps in knowledge and innovative solutions to improving women’s health by reducing EDC exposure risk.  
    • “For far too long, Black women have been overexposed to harmful endocrine-disrupting chemicals in personal care products. We created this competition to help find innovative solutions to meet this challenge, and I want to congratulate all the winners for their incredible ideas,” said HHS Secretary Xavier Becerra. “We will continue to prioritize the health of Black women by addressing the exposure risks caused by this environmental justice issue.”
  • Kaiser Family Foundation discusses community paramedic programs.
    • Most community paramedicine programs rely on paramedics, but some also use emergency medicine technicians, nurses, social workers, and other professionals, according to the 2017 survey. Programs can offer home visits, phone check-ins, or transportation to nonemergency destinations, such as urgent care clinics and mental health centers.
    • Many programs support people with chronic illnesses, patients recovering from surgeries or hospital stays, or frequent users of 911 and the ER. Other programs focus on public health, behavioral health, hospice care, or post-overdose response.
    • Community paramedics can provide in-home vaccinations, wound care, ultrasounds, and blood tests.

From the mental health care front

  • CVS Health calls our attention to
    • “A recent CVS Health® (NYSE: CVS)/Harris Poll survey found that young adults and physicians continue to see the country struggling with mental health, but most Americans aren’t seeking care.
      • “Six in 10 (60%) respondents aged 18-32 say they are concerned about their mental health, and two thirds (67%) say they know a lot of people in their community that are struggling with mental health issues.
      • “Most physicians (56%) also report declining mental health among their patients.
      • “However, only 1 in 10 (12%) Americans regularly see a mental health professional like a psychiatrist, psychologist, psychotherapist, or well-being therapist.” * *
    • “The survey also found that generations have different views of how to access mental health care.
      • “Ninety-five percent of respondents age 57+ agreed that mental health and illnesses should be taken more seriously by society, compared to 8 in 10 respondents aged 18-32 (83%).
      • “About six in 10 (58%) respondents aged 18-32 report that social media has negatively impacted their mental health, compared to just 22% of respondents age 57+.
      • “A higher number of respondents aged 33-40 believe in using technology to access care, with 85% agreeing that digital health services have made mental health more accessible.
  • The U.S. Surgeon General issued an advisory on the healing effects of social connection.
    • “Connection plays a critical role in individual, community, and societal health. This advisory calls attention to that role and offers a framework for how we can all contribute to improving social connection.”

From the U.S. healthcare business front —

  • BioPharma Dive relates
    • “Pfizer on Tuesday reported first quarter revenue that beat Wall Street forecasts despite declining by more than one-fourth compared to the same period in 2022 due to plummeting sales of the company’s COVID-19 vaccine.
    • “Sales of the COVID antiviral Paxlovid, at $4 billion for the quarter, were substantially higher than analysts expected, although the total was tied to the timing of the final delivery under a U.S. supply contract. CFO David Denton told investors that 2023 will be a “transitional” year as Paxlovid distribution shifts from government purchasing to commercial insurance.
    • “Executives affirmed guidance of 7% growth in non-COVID revenues for the full year, higher than the 5% growth in the first quarter. Hitting that target will require successful new drug launches, such as for a respiratory syncytial virus vaccine now under regulatory review and an experimental multiple myeloma treatment. Investors are also looking for better performance from drugs bought via dealmaking, such as the migraine pill Nurtec.”
  • and
    • “Johnson & Johnson has acquired rights to two experimental cell therapies for blood cancer in a move meant to build on the success it’s had developing a CAR-T treatment for multiple myeloma.
    • “The deal, announced Tuesday with the Maryland-based Cellular Biomedicine Group, has J&J paying $245 million upfront to gain access to two CAR-T therapies that have shown positive early-phase results in patients with recurrent diffuse large B cell lymphoma, or DLBCL, the most common form of non-Hodgkin lymphoma.
    • “The agreement increases J&J’s presence in the field of cell therapy. The big drugmaker already sells one treatment, known as Carvykti. The newly added therapies are in early testing or soon will be.  
  • Healthcare Dive reports
    • CVS has closed its acquisition of Oak Street Health for $10.6 billion in cash, pushing the retail health giant further into direct care delivery, CVS announced on Tuesday.
    • With the deal’s completion, CVS adds a multi-state chain of doctor-staffed medical clinics for seniors to its primary care roster.
    • CVS first announced the acquisition, which values Oak Street at $39 a share, in February.
  • On Monday,  “Blue Cross Blue Shield of Michigan and Blue Cross and Blue Shield of Vermont announced an agreement to formally affiliate and work together across both companies. The affiliation will enable the organizations to broaden the range of health plan and service solutions that will further benefit members and customer groups, while remaining within and committed to local communities in both states. The agreement is pending approval of state regulators.”

From the healthcare spending front —

  • Buck Consultants announced
    • “The impact of inflation is not yet fully reflected in medical trend factors, according to Buck, an integrated HR, pensions, and employee benefits consulting, technology, and administration services firm. The findings were released today in Buck’s 44th National Healthcare Trend Survey, a report that identifies trend factors that are used to project employers’ healthcare costs for 2023-2024.
    • “Buck’s annual survey of nearly 100 health insurers and health plan administrators covering more than 100 million plan participants found that while medical trend factors have yet to fully adjust for recent inflationary increases, they continue to increase at a rate consistent with trends reported in the prior survey, which will likely drive healthcare premiums higher in the coming year.
  • Health Payer Intelligence informs us,
    • “Payers with larger market shares tend to have lower prices nationally, a study published in Health Affairs confirmed.
    • “The researchers used data from Turquoise Health, a company that collects hospital price data from the hospitals’ websites, to determine the impact that payer market share can have on prices. The study covered prices for 14 potentially shoppable services with data from 1,446 acute care hospitals. The data was collected through the end of 2021.
    • “Prices were stable within hospitals but not across different payers. And the pricing was dependent, at least in part, on the payers’ market shares. * * *
    • “just as payers can use their market share to negotiate lower prices, the Congressional Budget Office (CBO) found that providers with higher market shares can use their market position to get higher reimbursement out of payers. Hospital consolidation was a key factor in price increases, the CBO report found.”

Friday Factoids

Photo by Sincerely Media on Unsplash

From the public health front —

  • Here are links to the CDC’s Covid Daily Tracker and its Fluview. It turns out that the CDC is planning one more issue of its Covid statistics review on May 12. All signs continue to support ending the PHE on May 11.
  • ABC News reports on the latest results of the Youth Risk Behavior Survey, published Thursday by the Centers for Disease Control and Prevention.
  • The GAO issued a report on government efforts to curb antibiotic resistance. The Wall Street Journal adds
    • A bipartisan group of U.S. senators and representatives introduced legislation aimed at encouraging drugmakers to develop antibiotics and antifungal drugs to address a growing public health threat. 
    • Bills that lawmakers proposed in the House and Senate on Thursday would commit $6 billion to purchasing new drugs to treat drug-resistant bacteria and fungi that federal officials designate as critically important targets. 
    • Nearly three million people in the U.S. are infected each year with bacteria immune to many antibiotics, the Centers for Disease Control and Prevention said. Some 35,000 of them die. The manufacturers of some promising antibiotics have gone bankrupt because sales of drugs needed only in emergencies are small, public-health experts said. Many big pharmaceutical companies got out of the antibiotic business years ago. 
  • The Hill tells us,
    • A record-low number of adults reported cigarette use in 2022, while reported usage of electronic cigarettes rose among adults. 
    • Preliminary survey results from the Centers for Disease Control and Prevention (CDC) found just 11 percent of American adults — or about 1 in 9 — reported they are smokers, which is a drop from 12.5 percent reported in 2020 and 2021. 
    • The new data, which is based on responses from 27,000 adults, captured an uptick in e-cigarette use among adults, from 4.5 percent who reported use in 2021 to 6 percent in 2022.
  • Fierce Pharma informs us.
    • With its next-generation pneumococcal vaccine, Pfizer has been playing catch-up with Merck in the indication’s key age group—infants. Thursday, Pfizer got to the finish line 10 months after its rival, but with a shot that offers more protection.
    • The FDA approval of Prevnar 20 covers children ages 6 weeks to 17 years and gives Pfizer a chance to continue to control a market it has dominated for two decades.
    • Prevnar 20 is Pfizer’s follow-on to Prevnar 13, offering protection against seven additional serotypes. Merck’s next-gen shot, Vaxneuvance, is a 15-valent vaccine.
    • In the U.S., the seven additional serotypes covered by Prevnar 20 have shown to be associated with antibiotic resistance and heightened disease severity, according to Pfizer. In children five and younger, the seven serotypes account for 37% of the incidence of pneumococcal disease.
  • STAT News points out
    • “To equip both clinicians and patients with the tools to prevent these [maternal health] tragedies, a group of experts * * * have developed a new, evidence-based preventive care plan for those who are at moderate to high risk of preeclampsia, a pregnancy complication that can drive blood pressure dangerously high and is a leading cause of maternal and infant deaths. The care plan, published Friday in the American Journal of Obstetrics and Gynecology, recommends a range of interventions to lower a patient’s risk, including at-home blood pressure checks, treatments like low-dose aspirin, and continuing to take any other needed heart medication, which people are often wary to do when pregnant. The plan also includes lifestyle recommendations for patients like eating a Mediterranean diet, exercising, and getting at least 7 hours of sleep per night.”

From the U.S. healthcare business front —

  • BioPharma Dive report
    • “AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January.
    • “U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes.
    • “Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker price.”
  • Becker’s Health IT provides more details about this week’s Kaiser Permanente deal with Geisinger, while Beckers ASC Review explores Optum’s physician acquisition strategy.