Thursday Miscellany

COVID-19 vaccine

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Medicare, Rx coverage, Telehealth–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Senate Finance Committee held a hearing today about “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs.”
  • Mercer Consulting informs us
    • “Two key House committees voted this week to send a series of health care bills to the House floor, including legislation to make permanent the ability of health savings account-qualifying high-deductible health plans (HSA-qualifying HDHPs) to cover telehealth and other remote care services on a predeductible basis. Originally enacted as part of the 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act, this flexibility was most recently extended as part of the 2023 Consolidated Appropriations Act, and now is set to expire on Dec. 31, 2024, for calendar-year plans (later for noncalendar-year plans).”
  • “The U.S. Department of Health and Human Services (HHS) released the STI Federal Implementation Plan to detail how various agencies and departments across the federal government are taking a comprehensive approach to making meaningful and substantive progress in improving public health. This new plan builds on other key HHS actions to protect the public’s health by addressing the growing threat of sexually transmitted infections (STIs) in America.”
    • Roll Call identifies potential obstacles to implementing this plan.
  • Govexec reports
    • “As smoke from Canadian wildfires moves into the Northeast and Mid-Atlantic regions of the United States, triggering air quality warnings in several cities, the Office of Personnel Management on Thursday reminded agencies to protect the health of federal workers who ordinarily may work or commute to work amid the hazardous haze.”
      • Healthcare Dive discusses health system reactions to this problem.
        • “Hospitals in the northeastern U.S. are keeping an eye on air quality as smoke from Canadian wildfires envelops the region. Most health systems contacted by Healthcare Dive did not report significant spikes in patient volumes yet, but they said they’re continuing to monitor the situation.
        • “Millions of people live in areas currently under air quality alerts, and meteorologists say conditions may not significantly improve for a few more days.
        • “Health systems in the region are urging residents to stay indoors and use masks — particularly snug-fitting N95s — when traveling outside. Though everyone should limit their time outdoors, it’s especially important for older people, children and pregnant women as well as those with conditions like heart or lung disease or asthma, according to Kristin Fless, a pulmonologist at RWJBarnabas Health Medical Group.”
  • The Wall Street Journal relates
    • “Ashish Jha, the White House Covid-19 czar, will be leaving his post next week in the latest sign the Biden administration is confident the country is on stronger footing in its fight against the virus.
    • “Jha plans to leave June 15 and return July 1 to his previous position as dean of Brown University’s School of Public Health. He will be the last of the administration’s rotating Covid-19 czars. Instead, the director of the White House’s nascent Office of Pandemic Preparedness and Response Policy, who hasn’t been named, will advise the president and coordinate federal responses to various biological and pandemic threats.”

From the  public health front —

  • Mercer Consulting tells us
    • Our research over the past few years has tracked the ways employers are working to align employee benefit programs with their organizations’ overarching DEI goals. For Pride month, here’s a round-up of survey results relating to health and well-being benefits of particular importance to the LGBTQ+ community.
    • Here’s a link to the article.
  • The American Hospital Association reports
    • “The first data on the safety of a third mRNA COVID-19 vaccine dose among young children show that a third dose is safe for children ages 6 months to 5 years old, similar to findings for doses one and two, the Centers for Disease Control and Prevention reportedtoday, based on reports to the Vaccine Adverse Event Reporting System and v-safe voluntary smartphone health checker for use after vaccination.
    • “This study’s findings can reassure health care professionals, parents, and caregivers that a third dose of COVID-19 vaccine is safe for children ages 6 months to 5 years and can protect them from severe illness,” CDC said.
    • “While CDC recommends that all children ages 6 months through 5 years old receive at least 1 bivalent mRNA COVID-19 vaccine dose, vaccination rates among this age group have been low.”
  • Health Payer Intelligence informs us
    • “Group health insurance plan members with high healthcare spending often have one or more of the same five chronic diseases, according to a fast facts sheet from the EBRI Center for Research on Health Benefits Innovation (EBRI CRHBI).
    • “The study covered healthcare claims from 8.6 million group insurance health plan members using 2021 data from the Merative MarketScan Commercial Database. Members were 65 years of age or younger and the health plans covered a variety of types.
    • “Five conditions were very common among the group health insurance plan members with the highest healthcare spending: heart disease, respiratory conditions, musculoskeletal conditions, nervous system conditions, and skin disorders. A couple of these are among the most expensive chronic diseases in the US. They are also some of the most common comorbidities.”

From the Rx coverage front —

  • BioPharma Dive notes that tomorrow a Food and Drug Administration advisory committee will consider recommending that the FDA give full marketing approval to the Alzheimer’s drug Leqembi.
    • “A closely watched Alzheimer’s disease medicine appears to be heading toward broader approval, as documents released Wednesday show the Food and Drug Administration appears to have few concerns with it.”
  • BioPharm Dive also tells us that “After years of disappointment, cancer vaccines show new promise. Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.”
    • “Moderna is testing its shot, mRNA-4157, together with Merck’s immunotherapy Keytruda in people with melanoma who have had their primary tumors removed. The goal of such “adjuvant” treatment is to prevent cancer from returning.
    • “In December, the company reported the two drugs reduced the relative risk of death or recurrence by 44% over Keytruda alone. The new data came from an analysis of the risk of cancer spreading to distant organs or tissues, or “distant metastasis free survival.”
    • “One-third of patients who receive Keytruda in this setting experience such spread, driving researchers’ work to come up with better options. “We know that patients with distant metastases experience more morbidity and mortality,” said Adnan Khattak, a clinical professor at Edith Cowan University in Australia, who presented the Moderna data at ASCO.
    • “In the combination trial, mRNA-4157 and Keytruda reduced the risk of distant spread or death by 65% compared to Keytruda alone.”
  • The Associated Press reports
    • “A growing shortage of common cancer treatments is forcing doctors to switch medications and delaying some care, prominent U.S. cancer centers say.
    • “The National Comprehensive Cancer Network said Wednesday that nearly all the centers it surveyed late last month were dealing with shortages of carboplatin and cisplatin, a pair of drugs used to treat a range of cancers. Some are no longer able to treat patients receiving carboplatin at the intended dose or schedule. 
    • “Dr. Kari Wisinski has had to turn to other treatments for some patients or switch the order in which people receive their drug combinations. She said she’s done that “hoping that within three months there will be a better carboplatin supply.” * * *
    • “The U.S. Food and Drug Administration has taken some steps to try to ease the chemotherapy shortage. The agency is allowing the temporary importation of some foreign-approved versions of cisplatin from factories registered with the FDA.”
  • Beckers Hospital Review adds “Seventy percent of the 20 most commonly prescribed medications from GoodRx are in shortage, according to databases from the FDA and the American Society of Health-System Pharmacists.” The article goes on to list the drugs subject to shortages.

From the Medicare front —

  • Beckers Payer Issues informs us
    • “The FDA and CMS are discussing how to handle obesity drugs in Medicare, Bloomberg Law reported June 7. 
    • “The two agencies are in talks over “what to do about obesity drugs,” FDA Commissioner Robert Califf said at the Biotechnology Innovation Organization convention in Boston. Mr. Califf’s comments indicate CMS could expand weight loss benefits, according to Bloomberg Law’s report. 
    • “New GLP-1 drugs to treat obesity and diabetes can be expensive, costing upward of $10,000 a year without insurance coverage. GLP-1 drugs, including Ozempic, Trulicity, Victoza and Mounjaro, are used to treat Type 2 diabetes. Wegovy and Saxenda are approved for weight loss.  
    • “Under current law, Medicare is prohibited from covering weight loss drugs. Drug manufacturers are lobbying Congress to require the program to pay for the drugs. Proposed legislation to pay for the drugs has stalled. 
    • “The drugs could have a big effect on Medicare Part D spending. If 10 percent of people with obesity covered by Medicare were prescribed a brand-name semaglutide, a type of GLP-1, the drug would cost Medicare $26.8 billion annually, according to a study published in the New England Journal of Medicine in March.”
  • and
    • “Medicare spending per person grew by an average of 4.6 percent annually between 2000 and 2022, according to a June 6 analysis from KFF. 
    • “KFF analyzed data from the 2023 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. 
    • “KFF said the “influx of the Baby Boomer Generation added many relatively younger, healthier people to the Medicare beginning in 2011,” while the share of adults aged 80 and older enrolled in the program also continues to grow. Growth in healthcare spending is attributed to this increased volume and use of services, along with the availability of new technologies and rising prices.”
      • 2018: $13,579
      • 2019: $14,189
      • 2020: $14,373
      • 2021: $15,139
      • 2022: $15,727

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.

Weekend update

David Ermer–CDC, Congress, COVID-19 vaccine, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Capitol Hill, the House of Representatives and the Senate will be in session this week for Committee business and floor voting.

From the Omicron and siblings front, Scientific American discusses how often people should receive the Covid vaccine.

  • “The bivalent booster now available in the U.S. came out in September 2022. It was formulated to cover the COVID-causing virus’s Omicron strains BA.4 and BA.5 and the original strains from 2020. After an initial wave of people received the booster in the fall and early winter, the rate of vaccinations has dropped.
  • “A number of fully vaccinated and boosted people would like another booster for additional protection, Schaffner says, but a much larger population has not yet received any booster at all. Only 16.7 percent of the U.S. population(about 55 million people) have had the latest one—far fewer than officials had hoped. “That’s clearly been a source of considerable disappointment to everyone in public health,” Schaffner says. “The current public health thrust is not to give people an additional booster but to get people to take the firstbivalent booster.”
  • “The CDC says it continues to monitor emerging data but maintains its recommendation of one updated COVID vaccine for eligible people aged six months and older. “Too few people, particularly those who are older and at high risk for severe COVID-19, have taken advantage of getting an updated COVID-19 vaccine. And we encourage eligible individuals to speak with their health care provider and consider receiving one,” says CDC representative Kristen Nordlund.”

From the U.S. healthcare business front —

  • Medscape considers whether doctors will start retiring en masse soon.
    • “The double whammy of pandemic burnout and the aging of baby boomer physicians has, indeed, the makings of some scary headlines. A recent surveyby Elsevier Health predicts that up to 75% of healthcare workers will leave the profession by 2025. And a 2020 study conducted by the Association of American Medical Colleges (AAMC) projected a shortfall of up to 139,000 physicians by 2033.
    • “We’ve paid a lot of attention to physician retirement,” says Michael Dill, AAMC’s director of workforce studies. “It’s a significant concern in terms of whether we have an adequate supply of physicians in the US to meet our nation’s medical care needs. Anyone who thinks otherwise is incorrect.”
  • Revcycle Intelligence discusses healthcare mergers and acquisitions that occurred in the first quarter of 2023.
    • “Healthcare merger and acquisition activity generated $12.4 billion in the first quarter of 2023, marking a significant year-over-year increase, according to a Kaufman Hall report.
    • “The M&A Quarterly Activity Report revealed there were 15 transactions in Q1 2023, down only slightly from the post-pandemic high of 17 in Q4 2022. The number of transactions increased compared to Q1 2022, when 12 deals were announced.
    • “The seller or smaller party had an average revenue of $827 million in Q1 2023, falling below the average size of $852 million in Q4 2022. One mega-merger was announced in Q1 2023—a transaction where the smaller party has an annual revenue exceeding $1 billion. This year’s mega-merger was between New Mexico-based Presbyterian Health Services and Iowa-based UnityPoint Health.”

From the fraud, waste, and abuse front, Fierce Healthcare reports

  • “Eighteen people, some of them practicing medical doctors, were criminally charged with participating in healthcare fraud schemes that exploited the COVID-19 pandemic and allegedly raked in $490 million.
  • “The schemes resulted from false billings to federal programs and theft from federally funded pandemic programs, according to the Department of Justice in a news release.
  • “In the widespread fraud takedown, federal authorities also targeted suppliers of COVID-19 over-the-counter tests who exploited federal partners by shipping tests to patients who did not want or need them. And the feds went after individuals who filed fraudulent claims to the Provider Relief Fund (PRF) and the manufacturers and distributors of fake COVID-19 vaccination record cards.
  • T”wo of the most significant criminal cases in this latest sweep were filed by federal prosecutors in the Central District of California.
  • “Dr. Anthony Hao Dinh allegedly bilked the federal government out of $150 million and he used these fraud proceeds for high-risk options trading, losing over $100 million, according to the Justice Department in an announcement on April 20.

From the healthy living front

  • The Wall Street Journal tells us,
    • “An ounce of prevention may be worth a pound of cure, but medical schools have traditionally given little weight to instruction on how to help patients live healthier lives.
    • “The future could look different as schools and residency training programs have begun to embrace a field known as lifestyle medicine, weaving teaching on nutrition, exercise and other healthy behaviors into the core curriculum of medical education. This new push aims to provide doctors with tools to tackle chronic but often preventable conditions such as heart disease, stroke and diabetes that affect six in ten adults in the U.S.
    • “Incorporating lifestyle medicine into medical-school curricula can resolve the inadequacies that exist in preparing physicians for the growing challenge of chronic disease,” says Jennifer Trilk, professor of biomedical sciences and director of lifestyle-medicine programs at the University of South Carolina School of Medicine Greenville, which in 2017 became the first medical school in the U.S. to incorporate more than 80 hours of lifestyle-medicine training over four years of undergraduate education.”
  • NPR Shots offers an explanation of “Unraveling a hidden cause of [female] UTIs — plus how to prevent them.
  • Fortune Well explains why “a diet rich in certain foods may help protect against miscarriage, new research says. Here’s what to eat—and avoid—if you’re pregnant or trying to conceive.

Tuesday’s Tidbits

David Ermer–COVID-19, COVID-19 vaccine, Electronic health records, FDA, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front

The Wall Street Journal reports

  • Americans seeking messenger RNA vaccines for Covid-19 for the first time will get one, updated shot targeting both the Omicron variant and the original strain of the virus under new moves rolled out Tuesday by federal health officials. 
  • The Food and Drug Administration also authorized a second booster of the updated shots for people at high risk of Covid-19, specifically people 65 years and older or people who have weak immune systems.
  • The agency’s actions mark the latest tweaks to Covid-19 vaccines, and could be followed up by further efforts to simplify the complicated vaccination regimen, perhaps by enshrining plans for a once-a-year shot for most people.
  • “The agency believes that this approach will help encourage future vaccination,” said Dr. Peter Marks, head of the FDA’s division that oversees vaccines. “Covid-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination.”

The U.S. Preventive Services Task Force maintained its I or incomplete grade for “visual skin examination by a clinician to screen for skin cancer in adolescents and adults.” In other words, USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of this screening examination.

The Department of Health and Human Services made available a readout from the Secretary’s roundtable on Black maternal health.

  • One critical action the Administration has taken to move the needle was implementing the state option to extend Medicaid’s postpartum coverage from two months to twelve months, a lifesaving opportunity made possible by President Biden’s American Rescue Plan (ARP) and made permanent by the Consolidated Appropriations Act, 2023 (CAA, 2023), which President Biden signed into law earlier this year. So far, 31 states and DC have signed on. Congresswoman Robin Kelly – who also sponsors the MOMMA’s Act, which aims to prevent maternal mortality – helped champion this extension. 
  • Participants who lead community organizations helped shine a light on what effective, scalable solutions can look like, and the outcomes speak for themselves.
  • Jennie Joseph shared that by removing barriers to care for women at higher risk for maternal mortality and morbidity, her organization has never had a mother or baby die in 25 years, and of the 1,200 patients served since 2020, only five babies were born premature.
  • Aza Nedhari remarked that her organization’s Home Visitation Program, which provides expectant and new parents with culturally congruent comprehensive home visiting services during pregnancy and postpartum, has supported over 2,000 families and has facilitated a zero percent mortality rate since 2015.

From the obesity treatment front

Healthcare Dive tells us.

  • Telehealth giant Teladoc Health is expanding its physician-based care product for employers to weight management and prediabetes, as interest explodes in drugs meant for diabetes control that are being more frequently prescribed for weight loss, resulting in nationwide shortages.
  • The medications, called GLP-1 drugs, include Novo Nordisk’s Ozempic, which has been at the center of a national conversation about health, weight loss and medication access as more people, especially celebrities, use the drug to lose weight.
  • The provider-based program, which includes access to a Teladoc-employed doctor for a personalized care plan, along with daily coaching with digital tools, will become available for diabetes prevention and weight management in the third quarter, the company told Healthcare Dive.

Beckers Payer Issues adds.

  • UnitedHealth Group CEO Andrew Witty told investors [last week] it is “good news” that there are innovations being made in weight management. 
  • “We need to get focused on the facts and reality of this marketplace. We need to really be clear about which patients really do benefit from these medicines and make sure we properly understand how they’re going to use those medicines,” Mr. Witty said. “So there’s a lot still to learn, I think, as these things progress through their final phases.”

From the interoperability front

  • HIMSS reports on its sessions held today.
  • The American Hospital Association relates.
    • About 84% of hospitals had posted a machine-readable file containing rate information by the end of first-quarter 2023, up from 65% the previous quarter, according to a report released today by Turquoise Health. The report also found that 183 commercial health insurers representing over 95% of U.S. commercially insured lives were publishing machine-readable files of their in-network negotiated rates and out-of-network allowed amounts, up from 68 in July 2022.

From the U.S. healthcare business front

  • The Wall Street Journal reports
    • Hospitals are joining the gig economy. 
    • Some of the nation’s largest hospital systems including Providence and Advocate Health are using apps similar to ride-hailing technology to attract scarce nurses. An app from ShiftKey lets workers bid for shifts. Another, CareRev, helps hospitals adjust pay to match supply, lowering rates for popular shifts and raising them to entice nurses to work overnight or holidays.
    • The embrace of gig work puts hospitals in more direct competition with the temporary-staffing agencies that siphoned away nurses during the pandemic. The apps help extend hospitals’ labor pool beyond their employees to other local nurses who value the highly flexible schedules of gig work. 
    • The shift is among many ways hospitals are revamping hiring, schedules and pay to give nurses more control and to fill staffing gaps created by persistent labor shortages. Vacancies are straining many hospitals’ operations despite recent hiring gains at hospitals and reports of softer demand from some temporary-staffing companies.
  • Healthcare Dive informs us
    • Pharmacists are arguing they should play a more active role in care teams by being allowed to practice the full scope of their license, according to comments at the HIMSS conference in Chicago.
    • Nearly half of U.S. counties have shortages of primary care providers, with just one of those doctors for every 1,500 people, while 61% of those counties have a high volume of retail pharmacy locations that could help make up the deficit, according to new data from health IT network Surescripts.
    • But pharmacists at HIMSS say they need access to a greater range of medical data to get there.
  • OPM held a session on this topic on the first day of its FEHB carrier conference on March 29.
  • Beckers Payer Issues reports
    • CVS Health has named Brian Kane as executive vice president and president of Aetna, effective September 1.
    • Mr. Kane will report directly to CVS President and CEO Karen Lynch. He is replacing Daniel Finke, who is stepping down for health reasons, according to an April 17 news release.

From the tidbits/miscellany department

  • The National Association of Letter Carriers calls attention to the fact that the Postal Service has issued Postal Service Health Benefits Program fact sheets for Postal employees and annuitants.
  • The Drug Channels blog makes ten predictions about how the Inflation Reduction Act will impact market access and drug channels.
  • Govexec predicts expanded childcare options and higher pay for childcare workers based on an executive order that the President signed today.

PSHBP IFR Released

David Ermer–CMS, COVID-19 vaccine, Medicare, OPM–

This afternoon, OPM’s Postal Service Health Benefits Program Interim Final Rule was timely posted on the Federal Register’s website. The FEHBlog estimates that deadline for public comment on the rule is Monday June 5, 2023.

From the Omicron and siblings front, Becker’s Hospital Review tells us

“The FDA is planning to make another COVID-19 booster that targets omicron available for high-risk individuals, The Washington Post reported April 3.

“Under the authorization, people 65 and older and those with weakened immune systems would be eligible to receive a booster dose four months after their last bivalent shot.

“The policy will be “permissive,” meaning the agency will allow people to get another booster but will not definitively recommend it, sources familiar with the matter told the Post.

“The FDA is expected to announce the plan within several weeks, and the CDC is expected to quickly endorse it, sources said. “

From the anomalies front, Fierce Healthcare informs us

“Cash prices for certain hospital services were lower than the average insurance rate in nearly half of the facilities examined in a new study, which could influence rate negotiations between payers and providers. 

“The study was published Monday in the journal Health Affairs and makes use of cash price data hospitals are required to disclose for 70 shoppable services. The findings suggest that some self-insured employers pay prices higher than the cash price, which could influence future negotiations with insurers or direct talks with providers. 

“Researchers looked at the cash prices, commercial negotiated rates and chargemaster prices disclosed by 2,379 hospitals as of Sept. 9, 2022, per a federal rule that went into effect in 2021.

“The average and the median cash price made up 64% and 65% of the chargemaster rate.

“About 12% of the cash prices were set the same as chargemaster rates, and other cash prices were predominantly priced in increments of 5% off the chargemaster rates (64% of the time),” the study said. 

“The study found that the cash prices were lower than the median commercial rates in 47% of cases, most often at hospitals with government or nonprofit ownership, located outside of metropolitan areas or located in counties with relatively high uninsurance rates or low median household incomes.

“Researchers also discovered that evaluation and management services were the most likely to have a lower cash price with 55% compared with medicine and surgery at 48%.”

From the Medicare Advantage front, Healthcare Finance confirms

“Health insurers and stakeholders have expressed support for the Centers for Medicare and Medicaid Services’ plan to phase in changes to the risk adjustment model over three years, in the 2024 Medicare Advantage Program and Part D Payment Policies released Friday.

“The model changes will begin in 2024, with the full brunt of phased-in risk adjustment to take effect in 2026, according to Susan Dentzer, president and CEO of America’s Physician Groups.

“We’re satisfied with this,” said Ms. Dentzer. “They mostly listened.”

“Insurers also voiced their support for the payment increase in the 2024 Medicare Advantage and Part D Rate Announcement.

“CMS anticipates a payment increase for Medicare Advantage plans of 3.32% from 2023 to 2024 as a result of various changes, including in risk adjustment.

“This compares to the 1.03% increase in revenue proposed in the 2024 Advance Notice released in February.”

“We appreciate that CMS recognized the serious concerns with several proposed policies in the Advance Rate Notice that would affect MA enrollees in 2024, including by phasing in changes over a period of three years,” said Matt Eyles, president and CEO of AHIP.

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19 vaccine, FDA, Medicare, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The Senate Finance Committee held a hearing today on “Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers.” Fierce Healthcare reports

Sen. Ron Johnson, R-Wisconsin, said during the hearing that “this whole area is ripe for gamesmanship.” He then asked Matthew Gibbs, PharmD and Capital Rx President, what Capital Rx’s model would bring to the table that sets it apart from other players like Amazon or Mark Cuban Cost Plus Drug that are aiming to shake up the traditional PBM space.

Gibbs emphasized Capital Rx’s focus on transparency, something that sets it apart in the broader market.

“Using a price index like NADAC, which is published by CMS, they actually do the survey of the pharmacies, and getting it more robust so that it’s not voluntary—today it’s a voluntary survey—and getting responses to that will lead us to the actual drug costs,” Gibbs said. “And then you can have your nuances of Costco, Mark Cuban. And the person can actually go in and look and actually be informed about the real prices once and for all. The only way is to level set.”

“We have the tools already,” he said. “We just need to employ them.”

Meanwhile, the National Council of State Legislatures discusses the wide variety of state laws being imposed on PBMs, which only complicates matters.

In Affordable Care Act New, MedPage Today reports, “A federal judge on Thursday struck down the Affordable Care Act (ACA) provision requiring all insurers to cover certain preventive services free of charge, angering the law’s supporters.” The FEHBlog won’t delve into this case now because he expects the U.S. Court of Appeals for the Fifth Circuit to promptly stay this decision.

From the Omicron and siblings front, WebMD tells us

The CDC has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website now explains.

16.4% of people in the U.S. have gotten the latest booster that was released in September, CDC data shows.

MedPage Today opines on a World Health Organization “Booster Update: Here’s What They Got Right and Wrong.”

In FDA / drug development news —

  • Beckers Hospital Review reports
    • On May 9 and May 10, an FDA advisory panel will discuss whether to recommend the agency approve what could be the first over-the-counter birth control pill. 
    • The pill, a 0.075-milligram norgestrel tablet [manufactured by French drugmaker Laboratoire HRA Pharma], “is proposed for nonprescription use as a once-daily oral contraceptive to prevent pregnancy,” according to a document published March 29 on the Federal Register.
  • BioPharma Dive informs us
    • “Johnson & Johnson will stop developing its experimental vaccine for respiratory syncytial virus in an unexpected retreat from a high-profile research effort that had put the pharmaceutical giant among the leading companies seeking to win the first approval of a preventive shot.
    • “The company said Wednesday it will discontinue a 23,000-person Phase 3 trial, called Evergreen, of its RSV vaccine in adults following a review of its drug pipeline. The company does not plan to develop the shot for pregnant women or infants, a spokesperson confirmed.
    • “J&J’s pullback comes amid a restructuring of its infectious disease division, which was reported by Fierce Pharma in February. Its decision also thins the RSV vaccine competition, leaving GSK and Pfizer in the lead with shots that are currently under review by the Food and Drug Administration. Moderna is also developing an RSV vaccine and could file for approval this year.”

From the U.S. healthcare business front —

Healthcare Dive relates

  • Walgreens’ growing U.S. healthcare segment is continuing to bolster the retail health chain’s financial performance. The business, which includes value-based provider VillageMD, recorded $1.6 billion in sales in the second quarter, an increase of $1.1 billion from last year.
  • VillageMD sales were up 30%, including a boost from its recent acquisition of medical group Summit Health. Specialty pharmacy Shields Health Solutions grew sales 41%, while at-home care provider CareCentrix’s sales were up 25%.
  • Thanks in part to a jump in revenue in its healthcare segment, Walgreens’ results beat Wall Street expectations even as profit declined more than 20% amid lower COVID-19 vaccine volumes and test sales, higher salary costs, opioid litigation charges and costs associated with its $3.5 billion investment in its Summit acquisition.

and

  • Oak Street Health disclosed on Thursday that the antitrust waiting period for its planned sale to CVS Health has expired.
  • CVS and Oak Street filed the required notification forms under the Hart-Scott-Rodino Act with the Department of Justice and Federal Trade Commission on Feb. 24. The waiting period under the HSR Act ended Monday, according to a new proxy filing from Oak Street.
  • The disclosure means the $10.6 billion deal has cleared one regulatory hurdle — companies can’t consummate mergers until the HSR waiting period expires — but regulators could still challenge the acquisition on antitrust grounds in the future.

From the healthcare studies front —

  • Bloomberg tells us the story behind a breast cancer scare. Last week, I noticed a breast cancer study report that struck the FEHBlog as overblown, and it turns out that this report is the breast cancer scare that Bloomberg discusses.
  • NBC News reports
    • “Losing weight — even if some pounds are gained back — may help your heart over the long term, according to a study published Tuesday in the journal Circulation: Cardiovascular Quality and Outcomes.
    • “The findings may be welcome news to those who have found it difficult to keep weight off and feared the risks thought to be associated with gaining weight back.
    • “In the new study, researchers analyzed data from 124 clinical trials with a total of more than 50,000 participants. They found that risk factors for heart disease and Type 2 diabetes decreased for people who lost weight through intensive behavioral programs. The diminished risk persisted for years after they were done with the programs, even if some, but not all, of the weight came back.”
    • “The whole time your weight is less than it would otherwise have been, your risk factors for heart disease are lower than they would have been,” co-author Susan Jebb, a professor of diet and population health at the University of Oxford in the United Kingdom, said in an email.
  • The Centers for Disease Control announced 
    • The expanded availability of opioid use disorder-related telehealth services and medications during the COVID-19 pandemic was associated with a lowered likelihood of fatal drug overdose among Medicare beneficiaries, according to a new study.
    • “The results of this study add to the growing research documenting the benefits of expanding the use of telehealth services for people with opioid use disorder, as well as the need to improve retention and access to medication treatment for opioid use disorder,” said lead author Christopher M. Jones, PharmD, DrPH, Director of the National Center for Injury Prevention and Control, CDC. “The findings from this collaborative study also highlight the importance of working across agencies to identify successful strategies to address and get ahead of the constantly evolving overdose crisis.”

From the healthcare quality front, Beckers Hospital Review relates

CVS and Optum have struggled to integrate behavioral health into their payer-provider models, Behavioral Health Business reported.

For Optum, the challenges lie in integrating all the different IT systems from the providers the company has bought, Trip Hofer, the CEO of Optum Behavioral Health Solutions, said at the news outlet’s VALUE conference. For example, Optum in 2022 acquired Kelsey Seybold Clinic, a medical group in Houston with 500 healthcare professionals.

“Kelsey Seybold says, ‘Trip, here’s my issue. I have access problems for depression, stress and anxiety for adults.’ And I’m like, ‘Well, we have a ton of solutions for you,'” Mr. Hofer said, according to the March 27 story. “Six months later, we still can’t get it implemented because it’s like, ‘Well, how do I get data back to them?'”

Deborah Fernandez-Turner, DO, deputy chief psychiatric officer of CVS payer subsidiary Aetna, said at the conference that it’s time-consuming and complex to build behavioral health into payer-provider companies.

CVS, for instance, has started bringing mental health providers and virtual behavioral health access into its MinuteClinics, according to the story.

Keep on truckin’

The FEHBlog had planned to discuss the OPM-AHIP carrier conference in this post. However, the second day of the conference was postponed today due to a power outage affecting the webinar operations. The second day will be rescheduled, and the FEHBlog will bring readers up to date then.

Tuesday’s Tidbits

David Ermer–COVID-19 vaccine–
Photo by Patrick Fore on Unsplash

From our Nation’s capital, the Wall Street Journal reports

President Biden said Tuesday he would nominate Julie Su, the No. 2 official at the Labor Department, to lead the agency, maintaining continuity within a department that played a prominent role in averting a rail strike last year.

Ms. Su, the current deputy secretary, was widely seen as the leading candidate to succeed departing Secretary Marty Walsh. Asian-American lawmakers and advocacy groups threw their support behind her, lobbying Mr. Biden to tap his first Asian-American cabinet secretary. Ms. Su, age 54, is Chinese-American.

The nomination now heads over to the Senate for its approval. The Secretary of Labor, the HHS Secretary, and the Treasury Secretary / IRS form the agencies responsible for the overseeing the Affordable Care Act.

From the Food and Drug Administration (FDA) front —

Endpoint News informs us

Pfizer and BioNTech are seeking full [FDA marketing] approval for their Omicron-targeted bivalent Covid shot, and they’re following an FDA advisory committee’s advice on “harmonizing” vaccine compositions.

The partners have filed a supplemental BLA for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as both a primary dose or a booster for patients over the age of 12. That means unvaccinated children and adults could skip the original primary series and receive a bivalent shot first.

The move is in response to an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) vote last month, intended to clear up confusion around varying primary and booster dose formulations and utilize vaccines that better target currently circulating strains of Covid.

MedPage Today relates

In two somewhat close votes, an FDA panel of outside experts recommended the agency approve Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, despite concerns over the potential risk for Guillain Barré syndrome.

By a tally of 7-4 for safety and efficacy (with one abstention in each case), the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said the evidence favors the RSV prefusion F protein vaccine (RSVPreF) — which carries a proposed trade name of Abrysvo — for reducing RSV-related lower respiratory tract infections in adults 60 and up.

However, VRBPAC members showed reservations ranging from the largely health study population, rather than the more vulnerable group of older adults who need the vaccine most, to the limited number of events for the main outcomes.

The Wall Street Journal reports

Federal regulators approved a drug to treat a debilitating disease using data collected about patients over decades, creating an opening for researchers of other rare conditions who often struggle to prove their treatments work.

The Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc.’s drug Skyclarys, or omaveloxolone, for treating the neurological disorder Friedreich’s ataxia in adults and adolescents age 16 and older.

The FDA last year said results from a single clinical trial didn’t sufficiently demonstrate the drug slows the progression of a disease that causes progressive damage to the spinal cord, muscle weakness, and movement problems and often kills people by age 35. Instead of running another trial, Reata submitted additional data including an analysis from a so-called natural history study that has continued to collect information about patients for more than two decades.

“Data created by patient communities can be regulatory grade,” said Annie Kennedy, chief of policy, advocacy and patient engagement at the EveryLife Foundation for Rare Diseases, a nonprofit advocacy group. “This approval is proof of that principle.”

MedPage Today adds

The FDA issued an import alert Tuesday to clamp down on the illegal importation of xylazine, an animal tranquilizer showing up more and more in illicit drugs.

“This action aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals,” the agency said in a press release.

Veterinarians legitimately use drug products containing xylazine to sedate large animals such as horses and deer, but it is not safe for use in people and may cause serious and life-threatening side effects, the FDA noted. However, “it has been identified as a contaminant found in combination with opioids such as illicit fentanyl, and in combination with other illicit products that contain stimulants such as methamphetamine and cocaine. People who use illicit drugs may not be aware of the presence of xylazine.”

From the U.S. healthcare front —

The American Health Association points out

Hospitals continue to experience the same challenges that made 2022 the worst financial year since the start of the COVID-19 pandemic, including higher labor expenses and lower patient volumes, according to the latest report on hospital finances from Kaufman Hall. Hospital operating margins fell from -0.7% in December 2022 to -1% in January 2023, following persistent negative margins throughout last year. Notably, drug expenses have increased 12% compared to YTD 2020. 

“While we have seen a stabilization in operating margins over the past several months, the trendline continues to show that hospitals will be in a tough spot financially for the foreseeable future,” said Erik Swanson, senior vice president of data and analytics for Kaufman Hall. “With future COVID surges possible and challenging financial months ahead for hospitals, managing cash on hand will be critical to weathering the storm.”

The Wall Street Journal explains how doctors are diagnosing patients with artificial intelligence.

From the mental health care front —

  • The Kaiser Family Foundation provides good news about the rapidly growing use of the 988 National Suicide Prevention and Crisis Hotline. “Since the launch of 988, Lifeline has received over 2.1 million contacts—consisting of over 1.43 million calls, over 416,000 chats, and more than 281,000 texts.” But, of course, the KKF study also notes some problems.
  • MedCity News tells us about a newly formed collaboration consisting of Bicycle Health, Wellpath and the Federal Bureau of Prisons that will provide virtual opioid use disorder services to those living in the Bureau’s residential reentry centers in 42 states.
  • STAT New discusses the downfall of Mindstrong, a mental health care tech / app company.
  • The Washington Post offers an intriguing look at how the human brain ages.

Midweek Update

David Ermer–Congress, COVID-19 vaccine, No Surprises Act, U.S. Healthcare–

From Washington D.C., Roll Call tells us

The federal government will run out of cash to pay all its bills sometime between July and September unless the statutory debt limit is lifted, the Congressional Budget Office [CBO] warned Wednesday.

The report by the nonpartisan budget scorekeeper could put pressure on a divided Congress to reach a deal to increase, or at least suspend, the debt limit before adjourning for the annual August recess.

[A] separate CBO report issued Wednesday underscores the challenges for both parties in making the math add up. Deficits over the next decade are now projected to grow by $3.1 trillion, or 20 percent, during the next decade from the agency’s forecast last May. 

STAT News “sat down with AMA President Jack Resneck on the sidelines of the [AMA’s Washington., D.C.] conference to talk about legislative reforms, physician burnout, and where the doctors’ lobby goes from here.” The Q&A made the FEHBlog crack up

What is the AMA stance on implementation of the law to end surprise medical bills for patients?

There’s a lot about the way those [HHS] rules were first written that went way outside of congressional intent. They put major thumbs on the scale of basically moving towards the insurers’ notion of what that value should be.

There’s so many things about those rules that basically would encourage insurers to either just say “Oh, I can pay so much less through this arbitration system that I’m just going to purposely not contract with any physicians” … or just unilaterally, dramatically lower payment rates in a way that threatens practices.

What nonsense!

Medical Economics shares a letter to Congress from a group of medical associations on the topic of value-based care.

The National Academies issued a report on “Achieving Whole Health.”

Whole health is physical, behavioral, spiritual, and socioeconomic well-being as defined by individuals, families, and communities. Whole health care is an interprofessional, team-based approach anchored in trusted relationships to promote well-being, prevent disease, and restore health. It aligns with a person’s life mission, aspiration, and purpose. It shifts the focus from a reactive disease-oriented medical care system to one that prioritizes disease prevention, health, and well-being. It changes the health care conversation from “What’s wrong with you?” to “What matters to you?”

The Office of Personnel Management released

its inaugural report: Government-wide DEIA: Our Progress and Path Forward to Building a Better Workforce for the American People. This report highlights accomplishments aligned with the Government-wide Strategic Plan to Advance DEIA in the Federal Workforce and preview priorities for 2023 consistent with Executive Order (EO) 14035.

“Whether you want to cure diseases, protect and preserve our national parks, combat climate change, or embark on missions to discover new galaxies, the Federal government is full of opportunity for the best and brightest to serve our country,” said OPM Director Kiran Ahuja. “In order to recruit and sustain the best talent, we must ensure every service-minded individual feels welcome and supported in contributing their talents to the Federal workforce. This inaugural report highlights progress made to advance diversity, equity, inclusion, and accessibility in the workplace, and we look forward to continuing the work to break down barriers to serve and help build a Federal government that draws from the strength and diversity of its people.”

Tomorrow, February 16, at 10 am ET, the Senate Commerce, Science, and Transportation Committee will hold a hearing titled “Bringing Transparency and Accountability to Pharmacy Benefit  Managers.”

This hearing will address how the “Pharmacy Benefit Manager Transparency Act” will bring transparency into PBM business practices and prohibit unfair or deceptive PBM conduct that drives up costs for consumers. The bipartisan S. 127, Pharmacy Benefit Manager Transparency Act of 2023, was introduced by Chair Cantwell and Sen. Chuck Grassley (R-Iowa), on January 27, 2023.

From the Omicron and siblings front —

STAT News reports

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution.

The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage. For those lacking sufficient insurance, the company will tap a patient assistance program. “Everyone in the U.S. will have access to Moderna’s Covid-19 vaccine regardless of their ability to pay,” the company said.

The about-face came on the same day that Sen. Bernie Sanders (I-Vt.), who chairs the Senate Committee on Health, Education, Labor, and Pensions, accused the company of “corporate greed” and scheduled a hearing next month to examine the initial decision to charge Americans for its Covid-19 shot. Moderna Chief Executive Officer Stéphane Bancel is among those expected to testify. * * *

A spokesman for America’s Health Insurance Plans, an industry trade group, suggested that health insurers will still get a bill. He sent a note saying the Advisory Committee on Immunization Practices (which advises the CDC) recently updated its list of recommended Covid vaccines and that, while beneficiaries pay nothing in cost sharing after commercialization, health plans are picking up the full cost.

No doubt about the validity of AHIP’s point.

Medscape notes, “The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.”

From the public health front —

  • The White House announced
    • “the Consumer Financial Protection Bureau (CFPB) released a new report that shows that the number of Americans with medical debt on their credit reports fell by 8.2 million from the first quarter of 2020 to the first quarter of 2022. Today’s report is consistent with a recent report from the Centers for Disease Control and Prevention (CDC) that found that the number of Americans who are part of families having trouble paying their medical bills declined by 5.5 million between 2020 and 2021. One driver of these declines is the significant increase in the number of insured Americans over this period, a result of the President’s strategy of protecting and strengthening the Affordable Care Act (ACA) and lowering health care costs. The decline also reflects continued actions by the CFPB to highlight problems with inaccurate reporting of debt in collections and put the industry on notice to correct their behavior.”
  • The Wall Street Journal reports “More older women with low-risk breast cancer could forgo radiation after surgery to avoid further side effects and costs, research showed, as some doctors work to limit tough treatments without hurting survival.” STAT News also offers an article on this topic.
  • The National Cancer Institute posts on a variety of cancer topics. For example
    • “The Food and Drug Administration (FDA) approved tucatinib (Tukysa) with trastuzumab (Herceptin) to treat HER2-positive advanced colorectal cancer. The approval was based on the MOUNTAINEER trial, in which nearly 40% of participants’ tumors shrank after receiving the drugs.”

In other health care cost news —

Beckers Payer Issues relates

Employer-sponsored plans pay much higher rates for physician-administered drugs than Medicare, a research letter published Feb. 10 in JAMA Health Forum found. 

Researchers at the Healthcare Cost Institute compared per-unit prices for the 10 most expensive and 10 most common physician-administered drugs from 2016 to 2020. 

For the most commonly used drugs, employer-sponsored plans paid prices up to 3,350 percent higher than Medicare. For midazolam, employer-sponsored plans paid 30 times more than Medicare for the same drug, and they paid 20 times more for ondansetron. 

For the most expensive drugs, employer-sponsored plans did not pay as extreme markups, the researchers found. Markups were  54 percent more than Medicare at the high end, and employer-sponsored plans paid similar prices to Medicare rates for some drugs. 

Read the full study here. 

Thank heavens OPM is allowing FEHB plans to offer Medicare Part D EGWPs for the Medicare prime members next year.

Health Payer Intelligence informs us “Out-of-pocket costs for buprenorphine prescriptions for opioid use disorder treatment decreased between 2015 and 2020, but costs varied by payer, according to a study published in JAMA Network Open.”

From the U.S. healthcare business front

Beckers Payers Issues advises

The nation’s largest payers have filed their fourth quarter earnings reports, revealing which have the most U.S. commercial members.
Commercial includes fully- and self-insured members

Commercial enrollment rankings in 2022:

  1. Elevance Health: 31.4 million
  2. UnitedHealth Group: 26.7 million
  3. Cigna: 22 million
  4. CVS Health (Aetna): 17 million
  5. Centene: 2.5 million
  6. Humana: 986,000

Healthcare Dive reports

  • After more than two decades together, CommonSpirit Health and AdventHealth are dissolving their joint venturemanaging hospital operations in Colorado and western Kansas. 
  • The management company, Centura, operates one of the largest hospital networks in the region, with 20 hospitals and a network of outpatient practices.
  • In a release on Tuesday, the systems said the partnership had reached its “natural maturity.” CommonSpirit and AdventHealth didn’t lay out a timeline for the transition.

and

Elevance has closed its deal to acquire specialty pharmacy BioPlus, the insurer announced Wednesday, after first announcing the buy in November 2022.

The acquisition builds off the Indianapolis-based insurer’s promise to acquire companies around its health services business, with Elevance CEO Gail Boudreaux announcing at a November industry conference that the insurer planned to grow “very aggressively” into adjacent care services.

Beckers Hospital Review tells us

Walgreens has agreed to buy the assets of defunct digital pharmacy Medly for $19.35 million, according to a bankruptcy court filing.

Medly declared bankruptcy in December, months after its founder stepped down and it laid off more than half its staff. A judge approved the acquisition of Medly’s assets, including its files, inventory and intellectual property, Feb. 7 in U.S. Bankruptcy Court for the District of Delaware.

Medly raised $100 million in 2020, positioning itself as a digital competitor to retail pharmacies such as Walgreens and CVS.

Monday Roundup

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

From our Nation’s capital, Federal News Network informs us

The Office of Management and Budget filled a key personnel and performance leadership role with a familiar name.

Federal News Networks has confirmed that Loren DeJonge Schulman is starting as the new associate director for performance and personnel management today.

She replaces Pam Coleman, who left in August after 20 months in that role.

DeJonge Schulman joins OMB from the Partnership for Public Service where she was vice president of research, evaluation and modernizing government for the last two-plus years. In that role, she helped lead the Best Places to Work in Government rankings and focused on issues around improving federal workforce management.

The U.S. Office of Personnel Management announced

The U.S. Office of Personnel Management (OPM) has announced the Finalists for this year’s Presidential Management Fellows (PMF) Program. Of the more than 10,000 individuals from around the world who applied for the program, 850 Finalists were chosen. The large number of applications to this competitive program marks a record number of applications over the past ten years.  

“Presidential Management Fellows are the next generation of government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2023 PMF finalists. We cannot wait to see what you will accomplish in public service.”  * * *

PMFs are appointed to a two-year, full-time Federal position with salary and benefits, where they apply their skills while engaging in leadership development training that includes experiential learning, cohort-based interactive training, and optional rotational experiences. 

In Omicron and siblings news, BioPharma Dive informs us

The U.S. has agreed to buy 1.5 million additional doses of Novavax’s COVID-19 vaccine as part of preparations for the government’s planned transition from bulk purchases to private market sales.

The agreement, announced Monday by Novavax, will support development of an updated version of the company’s shot in line with the Food and Drug Administration’s plan to annually match COVID vaccines to the most prevalent virus variants. It will also aid the company in developing smaller dose vials, which are less logistically challenging.

Novavax did not disclose the cost of the purchases, which are funded under an existing $1.6 billion contract with the government. Its shot uses a vaccine technology that has long been a mainstay and that the company claims remains an important option for those who cannot or will not take the messenger RNA-based shots from Pfizer and Moderna.

From the public health front —

  • The Washington Post discusses a horrifying CDC report on the mental health of high school students.
    • “Teen girls across the United States are ‘engulfed in a growing wave of violence and trauma,’ according to federal researchers who released data Monday showing increases in rape and sexual violence, as well as record levels of feeling sad or hopeless.”
    • In its report, the CDC steered attention to the nation’s schools, saying activities there can make a profound difference in the lives of teens. It recommended improved access to mental health services, more classroom management training for teachers, school clubs that foster gay-straight alliances, high-quality health education and enforcement of anti-harassment policies. Ideally, schools would take on multiple initiatives.”
  • NBC News reports “A handful of factors, such as education, income and job type, may increase the likelihood that people in their mid-50s will still be mentally sharp, a new study finds.”

From the No Surprises Act front, Healthcare Dive adds

One in five Americans still report receiving surprise bills, despite the ban. That’s in part because the law has notable exceptions — for example, ground ambulances were excluded from the ban, though they’re a frequent source of the bills.

In January, the HHS said it’s received significantly more requests to resolve payment disputes than the department expected.

STAT News delves into the ground ambulance billing issue today. It’s worth noting at the risk of belaboring the obvious that air ambulances are considerably more expensive than ground ambulances.

The FEHBlog was surprised to read about the number of arbitration requests in January given the Texas Medical Association’s contention that the new $350 per party arbitration fee would suppress the numbers of arbitrations. In the FEHBlog’s view, providers should place more focus on the open negotiation phase of the process.

From the electronic health records front, HealthITBuzz alerts us

A little over a year ago, we announced the completion of a critical 21st Century Cures Act requirement by publishing the Trusted Exchange Framework and Common Agreement (TEFCA). This milestone established a clear infrastructure model and governing approach for nationwide health information exchange.

Today, we marked the next major milestone during an event at the U.S. Department of Health and Human Services (HHS) headquarters, which recognized the first set of networks to be approved to implement TEFCA as prospective Qualified Health Information Networks (QHINs). Once fully onboarded, the organizations will officially be “designated” as QHINs. At this event, HHS Secretary Becerra recognized and congratulated CommonWell Health Alliance, eHealth Exchange, Epic TEFCA Interoperability Services, Health Gorilla, Kno2, and KONZA for their willingness to voluntarily step up and meet the rigorous TEFCA eligibility requirements, terms and conditions of TEFCA participation, and commitment to a 12-month go-live timeline. Collectively, the QHIN applicants have networks that cover most U.S. hospitals, tens of thousands of providers, and process billions of annual transactions across all fifty states.

Bravissimo.

From the U.S. healthcare business front —

Cigna announced a rebranding of its businesses: The Cigna Group, the global health company; Cigna Healthcare, the health benefits provider; and Evernorth Health Services, the pharmacy, care and benefits solutions provider.

Politico, upon examining whether a new CMS policy can save rural hospitals, offers us a mixed bag:

The Rural Emergency Hospital designation, aimed at sustaining emergency rooms, outpatient care and clinics, will be a major consideration for a significant number of hospitals, according to a new report from Chartis, a health care consulting group.

The policy changes are among the largest made to the rural health system in years. Through Medicare, hospitals that agree to the program requirements are guaranteed a set amount of money for facilities and a boosted Medicare reimbursement rate.

About 400 hospitals are “most likely” to consider conversion, according to the analysis, with about 80 of those “ideal” candidates for the change — often facilities on the brink of closing without growing revenues.

Several dozen hospitals are expected to move toward the new designation in the next 12 to 18 months “because they’re right on the ropes,” Michael Topchik, national leader of the Chartis Center for Rural Health, told Pulse.

Another group will wait and see how the first group does under the new rules, he said.

Still, most of the nearly 1,600 rural hospitals aren’t interested. The designation requires giving up inpatient care, a key part of many hospitals’ business and a handful of financial incentives offered through other rural health programs.

That doesn’t mean rural hospitals are thriving, though. Closures slowed significantly during the pandemic, likely because of the government’s infusion of resources through the pandemic, but are again ticking up.

Fierce Healthcare reports

Sanford Health and Fairview Health Services have agreed to push back their planned megamerger by two months.

The health systems said in a statement that they jointly determined they should “voluntarily” move the expected closure date for the deal to May 31, according to a report in MPR News. The merger was originally set to close March 31, but Minnesota Attorney General Keith Ellison asked the two providers to delay.

The deal includes 58 hospitals, and, if the two systems are joined, they would employ more than 80,000 people.

Friday Factoids

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, FDA, Rx coverage, U.S. Healthcare, Wellness–
Photo by Sincerely Media on Unsplash

From Capitol Hill, Fierce Healthcare tells us

Two top senators have reintroduced legislation that would introduce several reforms to pharmacy benefit managers, including prohibiting clawbacks of pharmacy payments. 

Sens. Maria Cantwell, D-Washington, and Chuck Grassley, R-Iowa, reintroduced on late Thursday the Pharmacy Benefit Manager Transparency Act and the Prescription Pricing for the People Act. The move shows the lawmakers are not backing down from going after PBMs in the latest Congress. 

Congress is a piker compared to OPM, which has been successfully “going after PBM’s” for over a decade.

From the public health front

  • All of the Omicron metrics are trending down. “As of January 25, 2023, there are 118 (3.7%) counties, districts, or territories with a high COVID-19 Community Level, 855 (26.6%) with a medium Community Level, and 2,242 (69.6%) with a low Community Level.”
  • Overall, about 268.9 million people or 81% of the total U.S. population, have had a single dose of Covid vaccine, “About 229.6 million people, or 69.2% of the total U.S. population, have completed a primary series.* More than 41.6 million people, or 19.9% of the eligible U.S. population ages five years and older, have received an updated (bivalent) booster dose.”
  • The CDC’s Weekly FluView again headlines, “Seasonal influenza activity continues to decline across the country.”
  • Turning to our longest-standing public health emergency, the U.S. Drug Enforcement Administration informs us

Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.

While scientists have not conducted much research on its effects, anecdotal reports suggest that users experience symptoms similar to those encountered via opioids, namely depression of the central nervous system. More specifically, effects associated with xylazine use include dry mouth, drowsiness, hypertension, respiratory depression, and even coma. Users can develop a physical dependence to xylazine, reporting withdrawal symptoms more serious than from heroin or methadone, such as sharp chest pains and seizures.

Note: Since xylazine is not an opioid, naloxone does not reverse its effects.

  • The Food and Drug Administration proposed changing from “time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.”
  • Bloomberg relates, “Americans aren’t exercising enough.  Less than a third of US adults meet suggested benchmarks for aerobic and muscle-building activities set out by health officials, according to a new study released on Thursday.”

From the Rx coverage front, STAT News reports, “After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs.” Time will tell.

From the electronic health records front —

  • MedCity News identifies five ways to inject intelligence into the prior authorization process.
  • Fierce Healthcare points out that

“A new report from the Georgetown University Center for Children and Families seeks to make several reforms to the Transparency in Coverage rule to ensure the data are more usable and accessible by researchers. The goal is to ensure that the data can be used to help regulators and lawmakers target policies that can boost coverage affordability. 

“’The good news is that many of the access and usability problems stem from the technical specifications provided by the Centers for Medicare & Medicaid Services [CMS],’ the report said. ‘Most can be fixed through administrative action and better enforcement, with minimum cost burdens for the plans and issuers.’”

From the U.S. healthcare business front —

  • MedCity News informs us that health insurers continue to receive a C grade from Leapfrog.
  • Fierce Healthcare tells us, “The Minnesota attorney general’s office has formally asked Sanford Health and Fairview Health Services to postpone the March 31 closing date of their proposed merger as it seeks more information on the repercussions of the deal, Chief Deputy Attorney General John Keller said during a public meeting held Wednesday evening. The Midwest nonprofit health systems had announced their 58-hospital merger plans in November, saying at the time that joining together would expand care quality and access across their rural and urban markets. The resulting organization would employ nearly 80,000 people.”
  • Healthcare Dive reports, “In a lawsuit filed Thursday, Cigna alleged that Amy Bricker’s appointment to chief product officer of CVS’s consumer segment places the payer’s trade secrets at risk and violates her noncompete agreement.” 
  • The Wall Street Journal reports that CVS and Walmart pharmacies will follow Walgreen’s lead by reducing their retail pharmacy hours. “CVS, in a recent notice to field leaders, said most of its reduced hours will be during times when there is low patient demand or when a store has only one pharmacist on site, which the company said is a “top pain point,” for its pharmacists.” Walmart will be closing its pharmacy at 7 pm rather than 9 pm.