Midweek update

COVID-19

Midweek update

David Ermer–CMS, Congress, COVID-19, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC —

  • Politico reports,
    • “The Senate Finance Committee is releasing the next in its parade of legislation targeted at pharmacy benefit managers — an industry that Democrats and Republicans on Capitol Hill argue drives up the cost of drugs.
    • “Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) — along with Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) — plan to unveil legislation that would require PBMs, which manage prescription drugs for health insurers, to report a broader range of data about their business practices. The lawmakers seek comment on their proposal.
    • “The bill would require PBMs to submit annual reports to the Medicare drug plans that detail information about the treatments the plan covers, the discounts PBMs negotiate with drugmakers on medicines and the fees they collect.
    • “It’s the latest in a plan from Wyden and Crapo, who released a roadmap in April of PBM-focused legislation they want the committee to pursue.”
  • The Senate Finance Committee adds,
    • “Senate Finance Committee Chair Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) today announced that the committee will mark up legislative proposals to modernize and enhance federal prescription drug programs on Wednesday, July 26th at 2 p.m. The committee package will focus on addressing pharmacy benefit manager practices that have grown increasingly complex and opaque in recent years at the expense of patients and taxpayers.”
  • The American Hospital Association further informs us,
    • “The House Education & Workforce Committee July 12 voted 39-0 to pass legislation (H.R. 4509) that would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and impose civil monetary penalties on hospitals that violate the requirement. * * *
    • “In other action, the committee also passed bills that would strengthen price transparency requirements for commercial group health plans (H.R. 4507); require that the plans’ contracts with service providers allow the employer/plan fiduciary to access all de-identified claims and encounter data (H.R. 4527); and require the plans to further report to the employer/fiduciary their financial arrangements with pharmacy benefit managers (H.R. 4508).”

From the public health front —

  • Beckers Clinical Leadership and Infection Control tells us,
    • “After identifying a new COVID-19 omicron subvariant — EU.1.1, a descendant of XBB.1.5 — in late June, its growth has slowed, according to the CDC. 
    • “Right now, the subvariant accounts for only 1.1 percent of cases in the U.S., data shows. Nationwide, hospitalizations and deaths both continue to decline. The CDC’s most recent data shows that hospitalizations decreased by 0.8 percent as of July 1, and deaths decreased by 9.1 percent in the same one-week period.
  • CNN reports
    • Childhood cancer diagnoses in the US have been trending up for more than a decade, according to a study published Tuesday in the Journal of the National Cancer Institute.
    • There were 14,381 new childhood cancer diagnoses in the US in 2019: about 177 new cases for every 1 million children and teens up to age 19. Incidence rates have dropped since reaching a peak in 2016 but are still about 8% higher than they were in 2003, when there were about 165 new cases for every 1 million children and teens.
    • “Overall, cancer is very rare in children and adolescents, and the increases were small,” said Dr. David Siegel, a pediatric oncologist and an epidemiologist with the US Centers for Disease Control and Prevention’s cancer division who was the lead author of the study. “Past studies have also reported increased survival rates. So the combination of increases in incidence and decreases in deaths means that there are more and more cancer survivors that need long-term care and resources.”
  • The U.S. Census Bureau issued a report examining “Racial/Ethnic Disparities in Disability by Health Condition.”
    • “The data show patterns in health-related disability among adults age 40 and older and key differences by sex, race and Hispanic origin.
      • “Among findings:
      • “Women were more likely than men to have health conditions that limited their daily activities.
      • “Asian (non-Hispanic) adults reported the lowest rates (17.2%) of disability-related health conditions.
      • “Black (non-Hispanic) adults (31.8%) and those reporting Other or multiple-race non-Hispanic identity (42.9%) were among those with higher rates.
  • The All of Us Program released its July 2023 Medical Minutes.

From the Rx coverage front

  • Per Healthcare Dive,
    • Major pharmacy benefits manager CVS Caremark is partnering with drug discounter GoodRx on a joint program to bring down out-of-pocket drug costs, the companies announced Wednesday.
    • Commercially insured customers will be able to pay GoodRx’s discounted pricing when filling commonly prescribed generic prescriptions at in-network pharmacies. The payments will be automatically applied to their deductibles and out-of-pocket limits.
    • The program, called Caremark Cost Saver, will be available for tens of millions of CVS Caremark clients’ members at in-network pharmacies starting January 2024.
  • Per Beckers Payer Issues,
    • ‘About two-thirds of patients who take popular weight loss drugs end their regimen within a year, according to a Prime Therapeutics study released July 11.
    • ‘Prime, a pharmacy benefit manager owned by 19 Blue Cross Blue Shield companies, analyzed pharmacy and medical claims of 4,255 patients who took GLP-1 receptor agonists — such as Ozempic and Wegovy — for weight loss in 2021. The study found only 32 percent of patients continued their weight loss treatment after one year. 
    • “The majority of patients aren’t getting the value of the product and there’s waste, especially with an expensive therapy,” Patrick Gleason, PharmD, Prime’s assistant vice president for health outcomes and a co-author of the analysis, told Reuters. “I was a little bit surprised by the persistency rate.”
  • STAT News delves into how Medicare Advantage plans are approaching the FDA’s approval of the infused Alzheimer’s drug Leqembi. The most illuminating part of the article concerns the Mayo Clinic.
    • As a condition of coverage, Medicare rolled out a new patient registry to collect more information from physicians prescribing Leqembi. Information is supposed to be submitted every six months. Physicians who had previewed the registry said it appeared to function, though many clinics are still finalizing protocols for prescribing Leqembi.
    • “I’m not sure it’s sufficiently detailed to answer the [coverage with evidence development] questions that the [national coverage decision] put forth. We and others would need to collect more detailed information to understand the true benefits and risks of the medicine,” said Ronald Petersen, the director of the Mayo Clinic Alzheimer’s Disease Research Center.
    • Mayo Clinic isn’t prescribing Leqembi yet, as it’s planning to launch an Alzheimer’s treatment clinic in October, Petersen said. He said there has been interest from patients, but it “hasn’t been a landslide.”
    • Petersen is hoping to start a new research study at Mayo Clinic to do more detailed monitoring on patients. To start, Mayo physicians will likely only agree to treat patients in the geographic area close to the facility so they can oversee the follow-up appointments.
    • “We’d be more than happy to share our data with broader communities or merge it with data from CMS. It is incumbent upon all of us to share data to learn from each other what works,” Petersen said.

From the U.S. healthcare business front —

  • MedPage Today points out
    • “Private equity acquisitions of U.S. physician practices have risen dramatically over the last decade, driving up consumer prices in the process, according to a new report.
    • “In 2012, there were 75 private equity deals for physician practices across a range of specialties; in 2021, there were 484, marking a more than six-fold increase, Richard Scheffler, PhD, of the University of California Berkeley, and colleagues found.
    • “Over the entire period, the largest number of deals occurred in dermatology (376), ophthalmology (276), gastroenterology (120), and primary care (118), collectively accounting for 81% of the activity, Scheffler and colleagues wrote in the report, a joint effort by the American Antitrust Institute, the Nicholas C. Petris Center on Health Care Markets and Consumer Welfare at the University of California Berkeley, and the Washington Center for Equitable Growth.”

In telehealth news,

  • Fierce Healthcare tells us,
    • “While payers should cover telehealth, where these services are the most valuable still requires investigation, according to a study in Information Systems Research.
    • “The Centers for Medicare & Medicaid Services made the rules about telehealth usage more flexible during the COVID-19 pandemic, and some lawmakers want to make those changes permanent. But that should not mean giving providers carte blanche approval in using the new technology, nor should payers cover all uses of telehealth, suggests a study by researchers with the University of Texas.
    • “Telehealth should not be regarded as a one-size-fits-all solution to virtualize healthcare,” the study said.
    • “Despite that, however, the study also states that “insurance plans should expand their telehealth coverage to include more providers and close the healthcare access divide in rural locations, which can reduce subsequent hospitalizations and unnecessary costs.”
    • “The authors argue that telehealth’s benefits can be seen in treating conditions and diseases with “high virtualization potential” such as mental health, skin problems, metabolic conditions and musculoskeletal diseases. However, telehealth did not significantly reduce visits to specialists or emergency departments for circulatory, respiratory or infectious diseases.
    • “Indranil Bardhan, Ph.D., one of the authors of the study, said in a press release that “people believed that telehealth would be the next big thing, the future of healthcare. But our research shows that its impact is not as straightforward as people might think. It’s more nuanced.”

Thursday Miscellany

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Wall Street Journal reports
  • STAT News adds
    • “Previous treatments for Alzheimer’s targeted the disease’s symptoms and not the underlying cause of worsening dementia. The debate among physicians is whether that 27% slowing seen with Leqembi is clinically meaningful enough to make the drug, which carries a list price of $26,500 per year, suitable for every patient who might want it.
    • “My general argument is that ‘clinically meaningful’ is personal and specific to a patient and their families, and it’s not something I or any provider can paternalistically determine,” said James Galvin, a neurologist who leads the Comprehensive Center for Brain Health at the University of Miami. “I can’t tell you what’s clinically meaningful to you.”
    • “Eisai’s trial enrolled patients with mild cognitive impairment or early-stage Alzheimer’s who also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. The drug’s label reflects the same narrowed patient population, estimated to encompass approximately 1 million people in the U.S., or just under 20% of those currently living with Alzheimer’s.
    • “In the drug’s prescribing label, the FDA recommends doctors test for a genetic mutation, affecting about 15% of people with Alzheimer’s, that increases the risks of ARIA and reduces the efficacy of Leqembi. The agency also warns doctors to take “additional caution” when considering prescribing to people who are taking blood thinners, which could increase the risk of serious brain bleeds.”
  • Here is a link to the FDA’s press release.
  • In closing, the Wall Street Journal points out
    • Drugmakers and researchers are working on dozens of potential [Alzheimer’s Disease] drugs. Next up for approval is another amyloid-reducing antibody drug, called donanemab, from Eli Lilly. In a small, mid-stage trial, donanemab also modestly slowed the cognitive decline of study subjects compared with placebo.
    • “As of early 2022, there were 143 drugs in clinical trials for Alzheimer’s disease, including 31 drugs in Phase 3, typically the last stage of testing before a drug can be approved, according to a report in Alzheimer’s & Dementia: Translational Research and Clinical Interventions.”
  • Federal News Network reports on OPM’s diminishing yet still excessive backlog of federal retirement claims.
  • Govexec tells us
    • “The Office of Personnel Management last week reminded agencies of the array of workplace flexibilities at their disposal such as leave and telework to help federal workers who have been impacted by natural disasters.
    • “The memo, distributed by OPM Director Kiran Ahuja to heads of federal agencies, corresponds with the start of the annual hurricane season and comes shortly after Typhoon Mawar caused disruptions in Guam and the Northern Mariana Islands, both of which are under U.S. jurisdiction.”

From the public health front —

  • The Associated Press reports
    • “Drinking water from nearly half of U.S. faucets likely contains “forever chemicals” that may cause cancer and other health problems, according to a government study released Wednesday.
    • “The synthetic compounds known collectively as PFAS are contaminating drinking water to varying extents in large cities and small towns — and in private wells and public systems, the U.S. Geological Survey said.
    • “Researchers described the study as the first nationwide effort to test for PFAS in tap water from private sources in addition to regulated ones. It builds on previous scientific findings that the chemicals are widespread, showing up in consumer products as diverse as nonstick pans, food packaging and water-resistant clothing and making their way into water supplies. * * *
    • “The heaviest exposures were in cities and near potential sources of the compounds, particularly in the Eastern Seaboard; Great Lakes and Great Plains urban centers; and Central and Southern California. Many of the tests, mostly in rural areas, found no PFAS.
    • “Based on the data, researchers estimated that at least one form of PFAS could be found in about 45% of tap water samples nationwide.
    • “The study underscores that private well users should have their water tested for PFAS and consider installing filters, said Faber of the Environmental Working Group. Filters containing activated carbon or reverse osmosis membranes can remove the compounds.”
  • The Wall Street Journal informs us
    • A new longitudinal study has examined the medical records of all citizens of Denmark over the age of 16, some 6.5 million people in all, for patterns of diagnosis, hospitalization and treatment for substance use between 1995 and 2021. In the paper, published in the journal JAMA Psychiatry in May, Dr. Oskar Hougaard Jefsen of Aarhus University and colleagues showed that people who had previously been diagnosed with cannabis use disorder were almost twice as likely to be diagnosed later with clinical depression. According to the Centers for Disease Control and Prevention, cannabis use disorder is characterized by craving marijuana, using it more often than intended, spending a lot of time using it, and having it interfere with friends, family and work.
    • Even more dramatically, the paper also found that people with cannabis use disorder were up to four times as likely to be diagnosed later with bipolar disorder with psychotic symptoms. As is true of many psychological disorders, the increased risk was higher in men than in women, and the more a person consumed, the greater the risk. The study did not distinguish between different forms and concentrations of cannabis.
    • Though the association was strong, the authors note that they can’t say for certain whether chronic and heavy cannabis use induces psychosis, or whether people prone to mental illness are more likely to be heavy users. It makes sense that people who feel the symptoms of incapacitating depression or mania, or who sense apparitions or voices only they can hear, might try to self-medicate with cannabis. Without a randomized controlled trial, which would be unethical in the extreme, it’s hard to untangle these strands definitively.
    • But the study is still eye-opening due to its sheer magnitude. With so many people over so many years, there is very little statistical “noise.” And because the information was gathered from the national Danish Health Registry, there were few dropouts—often a big problem in longitudinal studies. As much as possible, the researchers confirmed that the symptoms of a person’s psychiatric disorder emerged after their chronic cannabis use and diagnosis, not before, and that they compared people who were alike in all ways except the frequency of their use.
  • Beckers Hospital Review notes that “In an effort to prevent a repeat of last winter’s “tripledemic” of respiratory illnesses, public health officials are encouraging Americans to get not only a flu shot but also a COVID-19 vaccine and a new vaccine against the respiratory syncytial virus, The New York Times reported July 5.” The FEHBlog thinks that immunity created by the tripledemic will tamp down the viruses this year. Nevertheless, the FEHB plans to get all three vaccines.

From the telehealth and artificial intelligence fronts, we learn from

  • Healthcare Dive that
    • “Nearly one-third of American adults and 40% of adults under 34 report that they would be comfortable with an artificial intelligence-led primary care appointment, according to a new survey released by Outbreaks Near Me and SurveyMonkey.
    • “But the option isn’t their preference. Although survey respondents reported believing that AI in healthcare could reduce medical bias and improve diagnostic accuracy, over 80% of respondents would prefer seeing a human medical professional for prescribing pain medications, deciding when to go to the emergency room and other services.
    • “The latest survey suggests that, while AI hype may be on the upswing, entrenched patient attitudes and preferences for care could be slow to shift.”
  • and
    • “Mental healthcare led telehealth utilization for the sixth straight month in April, representing 68.4% of telehealth claim lines among privately insured patients, according to Fair Health’s April telehealth report.
    • “Although nationwide demand for telehealth services dipped by 5.4% from March to April this year, the percentage of telehealth claims related to mental health services grew for the fourth consecutive month.
  • and
    • “Telehealth patients across most medical specialties are less likely to attend follow-up appointments 90 days after a visit compared to in-person appointments, according to new research from Epic.
    • “The analysis of follow-up visits comes after a December report from Epic found most telehealth patients did not require a follow-up appointment in the three months after an initial visit. Mental health, physical medicine, and rehabilitation and pain medicine had the highest in-person follow-up rates compared to telehealth visits, according to the latest research.
    • “The[se] new telehealth stud[ies] come as federal lawmakers debate whether to make pandemic-era virtual care flexibilities permanent before they expire in 2024.”

From the U.S. healthcare business front

  • Beckers Payer Issues relates
    • “Eli Lilly is now the largest healthcare company in the world by market value, surpassing UnitedHealth Group, Bloomberg reported July 5. 
    • “The pharmaceutical company’s market capitalization surpassed UnitedHealth Group’s July 5 — the first time Eli Lilly has closed above UnitedHealth Group since 2013, according to Bloomberg. 
    • “Eli Lilly’s success is driven by Monjauro, its drug approved for diabetes treatment and expected to receive FDA approval for weight loss, analysts told Bloomberg. The drug is expected to net between $25 and $48 billion in sales once approved.”
  • STAT News tips its cap to Lilly’s leadership David Ricks, 55, Lilly’s CEO, and Daniel Skovronsky, 50, its chief scientific officer.
  • The American Hospital Association offers its two cents on the recent Wall Street Journal article about the state of hospital finances.
  • Fierce Healthcare tells us
    • “Baylor Scott & White Health (BSW) is adding dozens of Texas urgent care clinics to its network thanks to a newly announced deal with NextCare Urgent Care.
    • “Forty-one facilities in “fast-growing areas” such as Houston, San Antonio and Abilene will give the state’s largest nonprofit health system a foothold in new markets. The deal also catapults BSW to a new role as one of Texas’ major providers of urgent care services.
    • “We are dedicated to providing customers with as much choice as possible when seeking care,” Pete McCanna, CEO of BSW, said in a Thursday release from the system. “Through this venture, the NextCare sites across the state will be integrated into our ecosystem of offerings, which already includes 24/7 virtual care available to all Texans via MyBSWHealth.com.”
  • and
    • “Hospital outpatient departments are marking up the prices for biologic medicines more than physician offices, particularly for “innovator biologics” that have clinically equivalent and lower cost alternatives on the market, according to a new analysis from the Employee Benefit Research Institute (EBRI).
    • “These higher charges for these products among hospital outpatient departments (HOPDs) are “roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition,” the independent research group found in its review of a proprietary commercial claims database of 25 million people with private health insurance.
    • “While HOPDs tend to charge higher prices for all medicines relative to the [physician office], higher HOPD markups on biologic medicines are roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition,” Paul Fronstin, director of health benefits research at EBRI, and M. Christopher Roebuck, CEO of health policy research firm RxEconomics, wrote in the brief.”

 

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

The FEHBlog hopes his readers enjoyed their Fourth of July weekend. The FEHBlog certainly did.

From Washington, DC —

  • FedWeek informs us
    • “The House version of the annual defense authorization bill would require DoD and OPM to conduct a “comprehensive review of the civilian workforce on FEHB to ensure that all family members and dependents who are currently receiving benefits are in fact eligible.”
    • “The language, inserted as an amendment to a bill that could come to floor voting in the upcoming weeks, would be the most concrete response to date regarding an issue that has been the subject of repeated warnings from OPM’s inspector general’s office and most recently from the GAO: ineligible persons being covered in the program as family members.”
  • FEHBlog note — The largest internal control problem with FEHB eligibility stems from the fact that OPM does not take advantage of the HIPAA 820 electronic enrollment roster, which allows health plan carriers to reconcile premium to headcount. For example, if the carrier finds via the HIPAA 820 that it is not receiving premiums on a self and family enrollee, then the outcome may be disenrolling the individual and their covered family members in a fair way. In the FEHBlog’s view, it does not make sense to move forward with a family member eligibility audit until the HIPAA 820 transaction is operational in FEHB. That is the most logical first step.
  • Federal News Network provides us with background on OPM’s new employee assistance program guidance. In the FEHBlog’s opinion, OPM should team up EAPs with FEHB plans in order to better coordinate their respective coverages.
  • Fedweek also explains for the benefit of federal and postal employees how to continue FEGLI coverage into retirement.
  • Healthcare Dive relates
    • “The CMS is proposing to cut Medicare reimbursements to home health agencies by 2.2% next year, or $375 million less than providers received in 2023, according to draft regulation released Friday. 
    • “The agency said the proposed rule includes a 2.7% payment bump that’s offset by a 5.1% cut related to the Patient-Driven Groupings Model, which aimed to better sort patients into different payment categories by clinical need and other factors.
    • “The reimbursement changes also reflect an estimated 0.2% increase due to an updated fixed-dollar loss ratio, according to regulators.”

From the public health front —

  • CBS News reports
    • “Nearly 1 in 4 U.S. adults and older teens had still not caught COVID-19 by the end of last year, according to new estimates from the Centers for Disease Control and Prevention, while 77.5% had antibodies from at least one prior infection. The figures are based on the final batch of results from the agency’s nationwide studies of antibodies in Americans ages 16 and up. * * *
    • “Virtually every American ages 16 and older — 96.7% — had antibodies either from getting vaccinated, surviving the virus or some combination of the two by December, the CDC now estimates. The study found 77.5% had at least some of their immunity from a prior infection. * * *
    • Rates were similar among men and women. Black and White people also have similar prior infection rates, between 75% and 80%. 
    • Among other racial and ethnic groups, Asian Americans had the smallest proportion of people with antibodies from a prior infection, at 66.1%, while Hispanic people had the highest, at 80.6%.

From the Rx and medical devices coverage front —

  • BioPharma Dive points out
    • “Moderna on Wednesday said it’s submitted applications to regulatory agencies around the world in a bid to win approval of a new vaccine to fight respiratory syncytial virus, or RSV, in older adults.
    • “The company filed with regulatory agencies in Europe, Switzerland and Australia and began a rolling submission to the U.S. Food and Drug Administration for the vaccine, which is currently known as mRNA-1345. Future applications are planned for other nations as well.
    • “Moderna’s submissions come two months after the FDA approved the first RSV vaccine, developed by GSK. The agency cleared a second RSV shot from Pfizer weeks later. Both products are approved for use in patients who are at least 60 years old, the same group Moderna aims to treat.”
  • Forbes reports
    • “On Wednesday, medtech giant Abbott announced that its new leadless pacemaker system, Aveir DR, has been approved by the FDA. This is the first time the FDA has given a thumbs up to a device of this type for two different chambers of the heart, which opens up this technology to nearly any patient who needs a pacemaker.
    • “From a clinical perspective, we know that leadless pacing offers a number of important advantages to patients in terms of getting away from the complications related to traditional pacemakers,” says Leonard Ganz, a cardiologist and Abbot’s chief medical officer for cardiac rhythm management. “This will expand the number of patients who can benefit from leadless pacing many, manyfold,” he tells Forbes.” * * *
    • “Although pacemakers have been life-changing for millions of people, they do carry downsides, explains Ganz, in particular, risk of infection both from the surgical procedure needed to implant them as well as the leads themselves should their insulation become compromised. Leadless pacemakers, by contrast, are much smaller, don’t require surgical implantation and have no wires connected to the heart. Instead, they are injected using a catheter in a vein and placed directly in the heart in a way that allows for removal if need be. All of these factors significantly reduce the risk of complications.
    • “The first leadless pacemaker, manufactured by Medtronic, was cleared by the FDA in 2016. Abbott’s first leadless pacemaker, the Aveir VR, was approved by the FDA in March 2022. [In contrast to the new Abbott device, b]oth of these products only work in a single chamber of the heart. About 80% of the patients that require a pacemaker need shocks in two cardiac chambers in order to keep the desired heart rhythm.”
  • The New York Times discusses “food noise,” which the new weight loss drugs dissipate.
    • “The active ingredient in Ozempic and Wegovy is semaglutide, a compound that affects the areas in the brain that regulate appetite, Dr. Gabbay said; it also prompts the stomach to empty more slowly, making people taking the medication feel fuller faster and for longer. That satiation itself could blunt food noise, he said.
    • “There’s another theoretical framework for why Ozempic might quash food noise: Semaglutide activates receptors for a hormone called GLP-1. Studies in animals have shown those receptors are found in cells in regions of the brain that are particularly important for motivation and reward, pointing to one potential way semaglutide could influence cravings and desires. It’s possible, although not proven, that the same happens in humans, Dr. Hwang said, which could explain why people taking the medication sometimes report that the food (and, in some cases, alcohol) they used to crave no longer gives them joy.”

From the U.S. healthcare business front

  • Segal Consulting delves into health plan prior authorization practices.
  • The Wall Street Journal reports that “Some hospitals that spent big on nurses during the pandemic are now short on cash; Distressed institutions are closing unprofitable services, selling assets to avoid default on debts.” Ruh-roh!
  • Forbes reports
    • “Rite Aid reported a quarterly loss of more than $306 million as the drugstore chain grapples with the loss of customers from its Elixir pharmacy benefits business as executives work to turn around the struggling drugstore chain.
    • “Rite Aid, which has closed more than 140 unprofitable stores in the last two years, reported a fiscal first-quarter loss of $306.7 million, or $5.56 per share, for the period ended June 3, 2023. That compares with a loss of $110.2 million, or $2.03 per share, in last year’s first quarter.”

From the fraud, waste, and abuse front, HealthTech explains how the Justice Department is using advanced analytics to combat healthcare fraud.

From the medical research front, the National Institutes of Health announced that “The first clinical trial of a three-month TB treatment regimen is closing enrollment because of a high rate of unfavorable outcomes with the investigational course of treatment.” The FEHBlog appreciates NIH’s transparency.

Monday Roundup

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

From Washington DC —

Photo by Sven Read on Unsplash
  • Federal News Network reports,
    • “The House and Senate armed services committees each finished their work on their versions of next year’s defense authorization bill within a day of one another, with both key committees approving overall funding levels that closely match the Biden administration’s 2024 funding request of $842 billion in discretionary DoD spending.
    • “The Senate Armed Service Committee’s bill, approved behind closed doors on Friday, would authorize $844 billion next year, while the House version, debated in a public session a day earlier, would match the administration’s request.
    • “Another area of commonality: both committees endorsed the administration’s proposed pay increase for military service members, making it highly likely that they’ll receive a 2024 increase of 5.2%, the largest military pay raise since 2002.
    • “For now, the measures do not include language that would grant the administration’s request for the same pay raise for federal civilian workers. A provision to achieve that could still be added when the bills reach the House and Senate floors; however, a large faction of House Republicans is pushing an alternative plan that would make all civil servants’ pay increases “merit-based.”
  • The Centers for Medicare and Medicaid Services issued,
    • “a proposed rule that proposes to update payment rates and policies and includes requests for information under the end-stage renal disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2024. This rule also proposes an update to the Acute Kidney Injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2024. In addition, the rule proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2024, CMS is proposing to increase the ESRD PPS base rate to $269.99, increasing total payments to ESRD facilities by approximately 1.6 percent. The CY 2024 ESRD PPS proposed rule also includes several proposals and requests for information related to ESRD PPS payment policies.
  • The National Institutes of Health announced,
    • “The Biden-Harris Administration awarded $50 million to launch the Persistent Poverty Initiative, an initiative to alleviate the cumulative effects of persistent poverty on cancer outcomes by building research capacity, fostering cancer prevention research, and promoting the implementation of community-based programs. The Persistent Poverty Initiative is the first major program to address the structural and institutional factors of persistent poverty in the context of cancer. It is coordinated by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). These awards create five new Centers for Cancer Control Research in Persistent Poverty Areas that will advance key priorities of the Administration’s Cancer Moonshot — to reduce inequities in the structural drivers of cancer and prevent more cancers before they start by reducing tobacco use and making sure everyone has access to healthy food.”
  • FedScoop informs us,
    • “Most federal government employees will receive between four and eight additional hours of leave time in 2023, the U.S. Office of Personnel Management said.
    • “The 2023 leave year ending Jan. 13, 2024, will have 27 pay periods, OPM said in a memo sent on Monday to human resource directors of U.S. government agencies. That means most federal employees will receive an additional pay period’s worth of leave in 2023, which could be four, six, or eight hours depending on their accrual rate, according to the memo.
    • “The change doesn’t apply to agencies whose first pay period was Jan. 8, 2023, as they will have 26 pay periods, the memo said. 
    • “While most federal workers will get more leave time, the maximum carryover amount for annual leave – 240 hours for most employees and 360 hours for overseas employees – won’t change, OPM said. It encouraged agencies to remind affected workers to use any time over that limit before the end of the leave year so they don’t lose it.”

From the public health front —

  • CBS News tells us,
    • The Centers for Disease Control and Prevention is now separately tracking several new COVID-19 variants, the agency announced Friday, adding more Omicron descendants to an increasingly complex list of new strains that are competing nationwide. 
    • Among the new variants now being tracked by the CDC is EU.1.1, a strain first designated by scientists earlier this year over its rapid ascent in some European countries. 
    • The variant is a more distant descendant of the XBB.1.5 variant that had surged earlier this year, with a handful of more mutations to its spike protein that may be driving its spread. 
    • The CDC estimates that EU.1.1 is now 1.7% of U.S. cases nationwide but may have already reached as much as 8.7% of cases in the region spanning Colorado, Montana, North Dakota, South Dakota, Utah and Wyoming.
    • It is too early to know whether EU.1.1 will lead to new or different symptoms in the U.S.
  • FEHBlog note — Reassuringly, the variants remain descendants of the late, great Omicron.
  • Helio informs us,
    • “Prenatal lifestyle interventions delivered by an allied health professional, with individual delivery formats and a moderate number of sessions, decreased gestational weight gain., according to data published in JAMA Network Open.
    • “In addition, researchers observed associations with reduced gestational weight gain among physical activity and mixed behavioral interventions. 
    • “These findings suggest that future pragmatic research should focus on testing and evaluating components to inform implementation in varied antenatal care settings, including those with limited resources, to optimize population benefits for pregnant individuals and the next generation,” the researchers wrote.”

From the obesity drug front —

  • STAT News reports,
    • “Almost half of Americans would be willing to spend up to $100 a month for new weight loss medicines such as Wegovy, and one-third say they would indefinitely pay whatever they can afford to get the drugs, according to a new survey by STAT and The Harris Poll.
    • “Although 47% say they would only spend the money up to a point — such as losing a certain amount of weight, or up until a special event — demand is so great that nearly one-quarter said they would pay up to $250 each month. And another 17% percent are willing to shell out as much as $500 each month. The survey, which polled 2,046 U.S. adults, was conducted earlier this month.”
  • and
    • An experimental pill from Eli Lilly led to 14.7% weight loss on the highest dose in a 36-week trial, heating up the growing competition among drugmakers to develop an effective oral obesity therapy.
    • The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year. The full results, published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the American Diabetes Association conference.
    • Nonetheless, an overwhelming majority — 84% — believe insurance companies should cover the injectable medicines, which carry list prices ranging from $900 to $1,300 a month.
  • Meanwhile, Healthcare Dive relates,
    • “Pfizer is scrapping of one of two experimental weight-loss pills it’s been developing after spotting signs of potential safety concerns in clinical testing.  
    • “The company on Monday said the decision to stop testing of the pill, lotiglipron, was made after receiving the results from drug-drug interaction studies and observing liver enzyme elevations in early- and mid-stage tests. Patients with liver enzyme spikes, which can be signs of organ damage, didn’t have side effects or require treatment, Pfizer said.  
    • “Pfizer will now focus on its other, similar weight-loss prospect, danuglipron, which so far hasn’t had such concerns. Danuglipron is currently in Phase 2 testing in Type 2 diabetes and obesity, and could move into late-stage development by the end of the year.”  

In other Rx and medical device news

  • Biopharma Dive identifies five Food and Drug Administration (FDA) decisions to watch for in this third quarter of 2023.
  • Beckers Hospital Review points out
    • The FDA has given a fast-track designation to a drug designed to prevent infection from both influenza A and B strains created by San Diego-based Cidara Therapeutics, according to a June 22 news release.
    • The novel drug, CD388, is being developed alongside Janssen Pharmaceuticals primarily for flu prevention in adults who are high risk as well as for individuals for whom flu vaccines “are either ineffective or contraindicated,” the release states. 
    • The FDA’s decision could prove to be timely as early data from the flu season that is currently underway in the Southern Hemisphere is showing that both influenza A and B are both circulating.
  • MedTech Dive notes
    • “Dexcom next year will introduce a continuous glucose monitor aimed at the 25 million non-insulin-using Americans with Type 2 diabetes.
    • “The CGM, which is based on the Dexcom G7, will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.
    • “Dexcom’s analysis shows those patients want help understanding the effect of lifestyle on blood glucose and staying off insulin, leading the company to develop a revised set of features for the new device.” 

From the U.S. healthcare business front

  • The Wall Street Journal reports
    • “UnitedHealth Group will acquire Amedisys for $101 a share, or nearly $3.29 billion, upending a prior deal for the home-health provider to combine with Option Care Health
    • “Amedisys said Monday that it has agreed to a takeover by UnitedHealth’s Optum health-services arm in which each Amedisys share will be converted into the right to $101 in cash. 
    • “Amedisys will become a wholly owned subsidiary of UnitedHealth when the transaction is completed. UnitedHealth’s UnitedHealthcare is the biggest U.S. health insurer. Its Optum business includes a sprawling network of physician groups, surgery centers and other assets.” * * *
    • “The companies didn’t provide an expected closing date on the acquisition, which still needs to be approved by regulators and Amedisys shareholders. 
    • “The combination is likely to draw close antitrust scrutiny from the Federal Trade Commission. Optum will be seeking to take over the No. 2 competitor in the home-health business after recently absorbing the No. 3 company, according to analysts. * * *
    • “When it announced its offer for Amedisys, UnitedHealth said it was confident it could secure approval for the combination, partly because of how fragmented the home-health business is.”
  • Health Payer Intelligence points out
    • “What will happen to the volume and value of mergers and acquisitions in 2023? This is a question at the forefront of payers’ minds as the healthcare industry emerges from the uncertainties of the coronavirus pandemic.
    • “The twelve months ending on May 15, 2023, witnessed strong merger and acquisition volume despite various challenges, according to a report from PwC. At the end of the report’s timeframe, the volume of deals was nearly twice as high as the period of 2018 to 2020.
    • “Still, health services deals dipped slightly, dropping by four percent from 2022. Volume dropped from 1,738 in 2022 to 1,661 as of May 15, 2023.
    • “Deal values declined significantly by 15 percent. In 2022, deal value amounted to $100 billion. In the study’s timeframe, deal value totaled $85 billion. Megadeal values, specifically, have been more than halved in the last two years since 2021, a trend which might continue due to rate hikes.”

Weekend update

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The FEHBlog is back in DC this week.

And speaking of Washington, DC —

  • The U.S. Supreme Court has ten decisions to issue from its October 2022 term. Last week, the Supreme Court issued seven decisions. Its next decision day is Tuesday, June 27.
  • Last Friday, the President issued an Executive Order on Strengthening Access to Affordable, High Quality Contraception and Family Planning Services.
    • “Sec. 2.  Improving Access and Affordability Under the Affordable Care Act.  (a)  The Secretaries of the Treasury, Labor, and Health and Human Services (Secretaries) shall consider issuing guidance, consistent with applicable law, to further improve Americans’ ability to access contraception, without out-of-pocket expenses, under the Affordable Care Act.  In doing so, the Secretaries shall consider actions that would, to the greatest extent permitted by law:
    •           “(i)   ensure coverage of comprehensive contraceptive care, including all contraceptives approved, granted, or cleared by the Food and Drug Administration, without cost sharing for enrollees, participants, and beneficiaries; and
    •           “(ii)  streamline the process for patients and healthcare providers to request coverage, without cost sharing, of medically necessary contraception.
    •      “(b)  The Secretaries shall consider additional actions, as appropriate and consistent with applicable law, to promote increased access to affordable over-the-counter contraception, including emergency contraception.”
  • From the public health / medical research front –
  • Bloomberg Prognosis offers guidance on Covid boosters.
    • In April, a CDC advisory committee on immunization practices showed just how rapidly we can lose the protections vaccines offer, Wallace points out. A review of data from 20 states revealed the bivalent booster’s effectiveness in those 65 and older fell to 65% in the first two months. That dropped to 45% in four months and plummeted to 22% in six months.
    • Those numbers are part of the reason higher-risk people are offered second doses of the bivalent shot.
    • “If people are in these groups, I would not hesitate to take advantage of this additional protection, as well as considering taking other prevention strategies, like masking in indoor public spaces,” says Wallace.
    • If you’re unsure, a healthcare provider can explain which dosing strategy is right for you. 
  • Medscape informs us
    • Can common anti-depressants prevent COVID-19 infection? That’s the suggestion of research in BMC Medicine, based on infection trends among more than 5,600 mental health care patients in the United Kingdom from April to December 2020.
    • The report says that selective serotonin reuptake inhibitors (SSRIs) were particularly effective in blocking COVID-19 transmission.
    • “Mental health patients with a recent (previous 90 days) prescription for an SSRI had an almost 40% reduction in the likelihood of a positive COVID-19 test,” wrote the Center for Infectious Disease Research & Policy (CIDRAP) at the University of Minnesota.
    • Research showed that 27.7% of COVID-19-negative patients had taken at least one antidepressant medication within the last 90 days before they were admitted to a mental health care facility, compared to just over 16% of COVID-19 positive patients.  * * *
    • “The results of this study hint at the potential clinical benefit” of SSRIs on COVID-19 infection, said the lead author, Oleg Glebov of King’s College London, in a press release.
  • The Raleigh News Observer reports
    • “Until recently, if a heart stopped beating, it couldn’t be donated. Donor hearts typically come from patients determined to be brain dead, from which doctors can extract the beating organ and transplant it into its new owner. But a new study from Duke researchers found that using a heart that has been “reanimated” by a machine works just as well as traditional transplants. This method could expand the pool of heart donors by 30%, said Dr. Adam DeVore, a Duke researcher and author on the paper. DeVore said this method allows doctors to salvage hearts from a group of patients who previously had been unable to donate.
    • “Duke’s own heart transplant clinic has greatly benefited by drawing from this new pool of donors. DeVore said the program has doubled in size in the last year, which he credits in part to the new method.”
  • Emergency room physician Edwin Leap writes in his blog that heart attacks are on the rise in younger people.
    • “While I certainly try not to inflame anyone’s fears, I write this to say that people should be attentive to their symptoms. Even a person who is relatively young should be cautious if they have chest pain, difficulty breathing, profound weakness or dizziness/passing out. Of course, associated symptoms can include nausea, unexpected sweating (or diaphoresis), numbness or tingling in arms or face, or pain into jaw, neck or back. Of course, symptoms in women can be more subtle can can simply involve profound fatigue.
    • “What may be equally important is the idea that we should be take good care of ourselves. In the face of an increased level of risk for heart disease, it’s a good time to lose weight, exercise, stop smoking and eat a healthy diet. I would also suggest that everyone take their existing prescriptions, try hard to control their blood glucose in diabetes, manage their blood pressure and all the rest. We can’t control all of our health risks, but the ones which we can, we certainly should.
    • “Furthermore, even young people should find a primary care physician if possible, and establish a relationship with that physician. The screening exams that they perform, the regular exams, the attention to your health that they provide can truly be lifesaving.”
  • In the FEHBlog’s view, health plans should help all of their members connect with a primary care physician. Leverage that network.

From the Rx coverage front —

  • The Wall Street Journal confirms‘ that Novo Nordisk is preparing to request Food and Drug Administration approval for a Wegovy weight loss pill.
    • “Later this year, Novo Nordisk plans to ask U.S. and European drug regulators to approve the tablet.  Novo already sells a tablet form of semaglutide, Rybelsus, to treat Type 2 diabetes, though some people use it off-label for weight loss.
    • “Novo Nordisk’s Ozempic and Wegovy therapies and Lilly’s Mounjaro have emerged as viral sensations—touted by celebrities and discussed on Facebook and TikTok—because of their potential to help people lose significant weight.
    • “These types of drugs, first approved to treat diabetes, work by mimicking gut hormones that play a role in regulating blood sugar and, it has turned out, appetite. A key gut hormone is called glucagon-like peptide-1, or GLP-1. * * *
    • “BMO Capital Markets analyst Evan David Seigerman estimated that pill forms of weight-loss drugs could make up about 15% of the total market, which he predicts will reach $100 billion in annual sales worldwide in coming years.”

From the wellness front —

  • Fortune Well interviews longevity expert Dr. Peter Attia.
    • While Dr. Peter Attia, author of New York Times bestseller Outlive: The Science and Art of Longevity, said there’s no “silver bullet” to increase one’s health span and life span, there are still a variety of longevity-linked habits that may work for you to stave off age-related disease and early mortality. 
    • “People have so much more agency over this than they will ever believe if they don’t take the step to educate themselves on it,” Attia tells Oprah Winfrey this week for a series called The Life You Want on Oprah Daily. “A lot of people think, ‘Well, this is my lot in life’…It’s not the case at all.”
    • Exercise, nutrition, sleep, and managing emotional health by engaging with others and trying new hobbies are all associated with a longer, healthier life. 
    • For Attia, moving without distraction and staying outside is his secret sauce. 
  • and
    • offers guidance on the best timing for dinner from a health standpoint.
  • The Wall Street Journal discusses the health importance of controlling salt intake.

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • MedPage Today reports
    • “On Friday, President Biden announced his intent to choose former top North Carolina health official Mandy Cohen, MD, MPH, to lead the CDC.
    • “Dr. Cohen is one of the nation’s top physicians and health leaders with experience leading large and complex organization and a proven track record protecting Americans’ health and safety,” Biden said in a statement.” * * *
    • “Cohen earned her bachelor’s degree at Cornell University in Ithaca, New York, her medical degree from the Yale School of Medicine in New Haven, Connecticut, and her master’s in public health from the Harvard Public School of Health in Boston. She completed her residency at Massachusetts General Hospital.”
  • STAT News suggests that Dr. Cohen’s political experience will benefit the CDC. Dr. Cohen’s nomination does not require Senate confirmation. Senate confirmation of CDC Directors will become a prerequisite in 2025.
  • Per Reuters,
    • “The U.S. Supreme Court on Friday preserved the Justice Department’s power to unilaterally dismiss lawsuits filed under a law that lets whistleblowers sue businesses on behalf of the government to recover taxpayer money paid to companies based on false claims in exchange for a portion of any recovery.”
    • In the FEHBlog’s opinion, this is a logical and welcome outcome as the federal government should have control over litigation brought on its behalf.
  • Per the FDA’s website,
    • “Today, the FDA posted information on its website regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. This recommendation incorporates advisory committee input and is based on the totality of the available evidence to select the vaccine composition that the FDA anticipates will best protect public health. The agency anticipates the timely submission of the data and filings to support FDA action on updated COVID-19 vaccines in order to make vaccines available this fall that meet our standards for safety, effectiveness and quality. 
    • “On Thursday, the FDA granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy. The prescribing information includes a Boxed Warning for serious or fatal cytokine release syndrome (CRS). Other warnings and precautions include neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity (ICANS), serious infections, and tumor flare. Glofitamab-gxbm should only be administered by a healthcare professional with appropriate medical support to manage severe reactions, including CRS. View full prescribing information for Columvi.”

From the miscellany department —

  • Healthcare Dive reports
    • A second major health insurer is warning investors about higher-than-anticipated outpatient care utilization that could hike medical costs, potentially cutting into profits. [UnitedHealthCare was the first.]
    • Humana filed an 8-K with the U.S. Securities and Exchange Commission on Friday morning saying elevated outpatient trends are expected to push its medical loss ratio, a marker of how much payers spend on patient care, toward the high end of its outlook for both the second quarter and the full year.
  • NPR tells us
    • Pfizer is facing a shortage of penicillin due to increased demand and more diagnoses of syphilis, the company said in a letter to its customers this week. 
    • The company said there is an “impending stock out situation” for select Bicillin L-A and Bicillin C-R prefilled syringes, Pfizer’s brand name of injectable penicillin. 
    • Prefilled Bicillin L-A pediatric syringes are expected to begin running low by the end of June, while all Bicillin C-R syringes could begin diminishing in the third quarter of this year. 
    • Inventory is predicted to start recovering in the second and third quarters of 2024, Pfizer said. 
    • Penicillin is an antibiotic used to treat various types of infections, including sexually transmitted diseases, such as syphilis and pneumonia.
  • Medscape points out
    • The American Medical Association (AMA) on Wednesday said it will advise doctors to pay less attention to body mass index (BMI) in determining if a patient is at a healthy weight, saying the measure does not predict disease risk equally well across racial and ethnic groups.
    • BMI, a ratio of weight to height, has long been used to define underweight, “normal” weight, overweight, obesity and morbid obesity, despite mounting evidence that it is an inaccurate predictor of health risks on an individual level.
    • At the influential physician group’s annual meeting in Chicago, members voted adopt a new policy that says BMI should be just one factor in determining whether a patient is at a healthy weight. Other measures such as body composition, belly fat, waist circumference, and genetic factors are also important, the AMA said. * * *
    • The AMA’s new policy also says BMI should not be used as a sole criterion for denying insurance reimbursement.
  • MedPage Today interviews the new AMA President-elect, Dr. Bruce Scott.

Tuesday Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The House of Representatives Committee on Education and the Workforce held a hearing today to examine the policies and priorities of the Department of Health and Human Services.
  • STAT News adds
    • “A key House Republican ramped up his criticism of pharmacy benefit managers Tuesday, calling for the government to dismantle companies that have consolidated drug supply chain operations.
    • “We should break these PBMs up,” House Oversight Committee Chair James Comer (R-Ky.) said during an Education and Workforce Committee hearing. Health Secretary Xavier Becerra testified at the hearing on his department’s priorities. * * *
    • “Comer asked Becerra what the administration thinks should be done to reform PBMs.
    • “Transparency,” Becerra responded. “As they say, sunshine is the best disinfectant.”
  • STAT News reports from the Senate
    • “In another bid to lower prescription drug prices, U.S. Sen. Bernie Sanders (I-Vt.) issued a report showing that medicines developed with help from the National Institutes of Health have often cost Americans more than what is paid in other countries. And he called on the agency to reinstate a provision in federal law that would require companies to set reasonable prices when they license NIH inventions. * * *
    • “The report was issued as the Biden administration seeks confirmation of Monica Bertagnolli, who currently heads the National Cancer Institute and was nominated to run the NIH. But the confirmation cannot proceed without support from Sanders because, as chair of the Senate health committee, he controls when nominees are reviewed for positions in the Department of Health and Human Services.
    • “However, Sanders threatened that he will not proceed until the Biden administration provides a “comprehensive” plan to lower prescription drug prices. The White House reportedly responded by acknowledging that prescription drug costs remain high for many Americans and pointed to the Inflation Reduction Act, a recently enacted law that allows Medicare to negotiate prices for certain medicines.”
  • Fierce Healthcare reports
    • “The Biden administration is rolling out new flexibilities that aim to prevent procedural coverage losses as states work through a backlog of Medicaid eligibility determinations.
    • “The Department of Health and Human Services announced that managed care plans can take on a more direct role in assisting members in completing renewal forms. This extends to filling out certain parts of the paperwork on behalf of the member.
    • “In addition, states are able to delay administrative disenrollments by a month for further outreach, which will allow for greater time to fill out necessary forms and paperwork. The agency will also allow pharmacies and community-based organizations to assist in getting coverage reinstated for people who are still eligible but lost coverage for procedural reasons.
    • “Procedural disenrollment is a key concern during the Medicaid redetermination period, as many people who are at risk of losing coverage are not aware that the process is even going on. A recent analysis from KFF looking at early redetermination data found that in a number of states, large numbers of disenrollments are linked to administrative issues.”
  • and
    • “Industry hospital groups are pushing the Centers for Medicare & Medicaid Services (CMS) to consider a higher annual pay bump and to shed some light on why it believes the number of uninsured patients won’t be increasing during fiscal year 2024.
    • “In April, CMS released its proposed fiscal year 2024 Inpatient Prospective Payment Systems (IPPS) rule with a 2.8% increase in payments for the 12-month period beginning in October.
    • “The tentative pay raise for eligible participating hospitals translates to a collective $3.3 billion increase, CMS said at the time, and is based on a 3% projected hospital market basket update minus a 0.2 percentage point productivity adjustment.
    • “Comment letters submitted by the American Hospital Association (AHA) and other major hospital industry groups on Friday homed in on the 2.8% net update as “woefully inadequate” in light of cost pressures, such as inflation and labor spend, that have not subsided since the height of the COVID-19 pandemic.”

From the public health front —

  • The Wall Street Journal tells us
    • “Longevity researchers have spent decades hunting for a magic pill to slow the aging process. But the best solution—at least for now—may be the simplest one: Move more.
    • “No single thing—whether it’s regular cold plunges or off-label drugs and supplements like metformin, rapamycin or taurine—has a track record that can match exercise’s in terms of protecting against age-related diseases and helping people get more from their later years, a vast body of research shows.
    • “The muscle and bone growth stimulated by exercise can help older adults maintain their independence, lessen fatigue and protect against bad injuries from falls, the leading cause of injury-related death among those over 65. 
    • “Regular exercise can reduce the risk of developing certain age-related diseases, including Alzheimer’s, cancer, diabetes and cardiovascular disease. * * *
    • “Any amount of physical activity can help extend a person’s life, research suggests, especially for people who currently are doing very little. Federal guidelines recommend that adults get at least 150 minutes of moderate-intensity exercise a week. 
    • “A team of researchers who analyzed data on more than 650,000 adults over about a decade found that, compared with those who were inactive, those who got about half the government’s recommended physical activity added an average of 1.8 years to their lives. Those who exercised for roughly five to eight hours weekly gained an average of 4.2 years.
    • “When you think about that, in terms of how many years you’re gaining per how many minutes of activity, it’s a very sizable yield,” says Steven C. Moore, the study’s lead author and senior investigator at the National Cancer Institute.”
  • Healthcare Dive informs us
    • “Uber will soon be able to deliver groceries and other over-the-counter items to patients of its payer and provider clients, in the latest benefits expansion of its Uber Health platform.
    • “Uber Health, which already provides non-emergency medical transportation and prescription delivery, has been expanding beyond medical transportation to care coordination across multiple benefits, Catilin Donovan, the head of the division, said in an interview. Soon, provider users will have access to patient benefit data and eligibility files from their health insurers, so they can prescribe services they know are covered.
    • Uber is not yet giving specifics of Uber Health’s financial performance, but Uber Health grew bookings by 75% year over year in the first quarter. Donovan declined to say whether Uber Health was profitable.”
  • The Government Accountability Office released a watchdog report on law enforcement-oriented approaches to reducing deaths from drunk driving.
  • The All of Us campaign issued its June report.

From the medical research front,

  • The National Institutes of Health announced
    • “Repeat treatment with corticosteroid injections improved vision in people with persistent or recurrent uveitis-related macular edema better than two other therapies, according to results from a clinical trial funded by the National Eye Institute (NEI). Compared with methotrexate or ranibizumab intravitreal (in-the-eye) injections, the corticosteroid treatment achieved greater reductions in retinal swelling and was the only therapy in the study that improved vision. The report was published today in the journal Ophthalmology. NEI is part of the National Institutes of Health.”
  • The Cigna Newsroom relates,
    • “A new study by Cigna Healthcare found that site-of-care redirection is associated with favorable clinical outcomes and increased access and affordability for peg­filgrastim, an injection used to prevent infection in cancer patients. The results showed that patients experienced better outcomes when the injection was administered in a home setting rather than a nonhome setting. The study was recently published in the Journal of Clinical Pathways.
    • “This study shows that we can help improve health outcomes by providing cancer patients with treatment such as infusions in a setting where many are most comfortable – home,” said Dr. Scott Josephs, chief medical officer, Cigna Healthcare. “These findings confirm that home infusion of complex and expensive specialty medications presents new opportunities to maximize access, improve effectiveness, increase affordability, and enhance convenience for patients.”

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • Roll Call tells us “A disagreement between Speaker Kevin McCarthy and House conservatives that jammed up legislative business last week eased Monday evening, but members of the rebel bloc made clear it may not be the end of trouble for their leadership.”
  • Govexec informs us
    • “After multiple years of significant spending increases at non-defense agencies, Congress has reverted to austerity by demanding an overall freeze of discretionary funding for domestic agencies. 
    • “The pullback, agreed to as part of a deal struck by President Biden and House Republicans to meet GOP demands for raising the debt ceiling, will force agencies to make difficult decisions as they abandon some efforts to launch new programs and grow existing ones. The 2023 Fiscal Responsibility Act set only a top-level cap for non-defense spending, leaving it to Congress to establish line-by-line funding levels across government. 
    • “The impacts will look different agency to agency,” said Rachel Snyderman, a senior associate director at the Bipartisan Policy Center and former Office of Management and Budget official.”
  • Federal News Network helpfully reviews the 71 public comments submitted to OPM in response to its April 6, 2023, interim final rule implementing the Postal Service Health Benefits Program.
  • Health Payer Intelligence relates, “AHIP offered four recommendations to the Senate Finance Committee on Consolidation and Competition (the Committee) [last week] to support healthy competition and lower healthcare spending in the healthcare industry.”

From the litigation front —

  • Yahoo News reports,
    • “The Biden administration on Monday finalized a deal to preserve the federal mandate requiring U.S. health insurers to cover preventive care like cancer screenings and HIV-preventing medication at no extra cost to patients while a legal challenge continues.
    • “The agreement, first disclosed on Friday and now finalized in a filing in the New Orleans-based 5th U.S. Circuit Court of Appeals, leaves the mandate in place nationwide while the administration appeals a court order striking it down.
    • “It does allow Texas-based Braidwood Management, one of a group of businesses and individuals that sued to challenge the mandate, to stop covering pre-exposure prophylaxis (PrEP) against HIV and other preventive services for its employees for now. The administration agreed not to take any retroactive enforcement action against the company, which operates an alternative health center if the mandate is restored on appeal.”
  • STAT News adds,
    • “The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price negotiation program on Friday, arguing that Congress tried to take too much power away from the courts.
    • “The lawsuit is the second to challenge the new program, enacted by Democrats last August in the Inflation Reduction Act, within a week’s time, but relies on different legal reasoning. Merck, which makes a diabetes drug that could be subject to negotiation, sued on Tuesday.
    • “Medicare is supposed to choose the first ten drugs to be negotiated by the program by Sept. 1. The goal of the lawsuits is to slow down or stop the process from going into effect.”

From the public health front —

  • Politico relates,
    • “The FDA’s independent advisers will discuss and recommend this week which strain of SARS-CoV-2 should be included in the newest Covid booster to be rolled out ahead of fall and winter. The FDA doesn’t have to follow its advisers’ recommendations, but it often does.
    • “Since the beginning of the year, the regulatory agency has made it clear that it will shift gears to prepare for annual Covid-19 shots as the virus becomes endemic. Now that we’re four months out from the intended rollout, the FDA must select a strain that will most likely be prevalent so manufacturers can start developing vaccines.
    • “Novavax, Pfizer-BioNTech and Moderna, the companies that manufacture the three vaccines available in the U.S., need the FDA’s recommendations to begin tweaking their existing platforms. They must also conduct clinical trials to show that the updated formulas generate a similar immune response to their existing products.”
  • MedPage Today reports,
    • “Oseltamivir (Tamiflu) has not panned out for reducing the risk of influenza hospitalization, according to a large meta-analysis.
    • “Among over 6,000 flu patients across 15 studies, the 0.14-percentage point difference in hospitalization rate between those who took oseltamivir and those who did not was not significant (RR 0.77, 95% CI 0.47-1.27), Emily McDonald, MD, MSc, of McGill University Health Centre in Montreal, and colleagues reported in JAMA Internal Medicine.
    • “I wouldn’t prescribe it to an otherwise healthy person,” McDonald told MedPage Today. “There was little evidence that it would prevent you from going to the hospital.”
    • “What’s more, she added, “it’s not completely benign. It does cause uncomfortable side effects.”
  • The Wall Street Journal reports,
    • “During the pandemic, Carl Prudhomme of Alpine, Texas, got his cancer drugs mailed directly to him from his oncologist.
    • “No longer. With the end of the Covid-19 public-health emergency, independent cancer doctors can no longer send prescriptions directly to their Medicare patients—creating hurdles for some people in rural areas who say they have to travel to get their medications. Prudhomme plans to drive the 569 miles each way to his oncologist’s office in Houston every three months to pick up his drugs in person.
    • “The Centers for Medicare and Medicaid Services in September 2021 posted a list of frequently asked questions that said independent oncologists can dispense prescriptions only to a patient who is physically in the doctor’s office at the time. 
    • “Sending oral chemotherapy drugs by mail violates the Stark law, the agency said. The law bans doctors from making referrals of Medicare and Medicaid patients to other organizations or medical businesses where they have a financial stake. The restriction also applies to other independent practices, such as urology, that have an on-site dispensing pharmacy.
    • “Roughly 30% of the more than 5,000 independent oncologists in the U.S. have on-site pharmacies in their practices, according to an analysis led by the University of Pennsylvania’s Perelman School of Medicine. 
    • “The restriction was suspended during the pandemic public-health emergency. Its return has alarmed cancer doctors who are lobbying Congress and CMS to rescind the restriction, even if that means undergoing new rule-making to do so.”

From the U.S. healthcare business front —

  • Fierce Healthcare tells us,
    • “Prior authorization has been a flashpoint for providers, and, while insurers have taken steps to ease these utilization management protocols, they still play a key role as the industry shifts to value-based care.
    • “David Brailer, M.D., executive vice president and chief health officer at the Cigna Group, told Fierce Healthcare in an interview that ultimately the goal is to ensure patients are receiving the best treatment option for them.
    • “And the insurer has seen that in more advanced value-based arrangments, it can relax prior authorization and other utilization management tools, Brailer said. 
    • “That’s going to be a few years before the market shifts,” he said. “We’ve already announced that we’re starting to step down the number of prior auths that we have.”
  • STAT News relates,
    • “Novartis said on Monday it would purchase Chinook Therapeutics for $3.2 billion upfront, picking up two drugs for a chronic kidney disease that are in late-stage clinical trials.
    • “The transaction values Seattle-based Chinook at $40 a share, compared to Friday’s closing price of under $24. The agreement includes another $300 million if certain regulatory milestones are reached.”
  • Healthcare Dive points out
    • CVS Health’s decision to shut down its two-year-old clinical trials unit means less competition for the growing group of retailers in research, but the area is still nascent and potentially challenging for new entrants, experts said.
    • “It may sort of spook some pharma companies who may think that if CVS exited, maybe these other companies will also exit, and it may make them a little bit more hesitant to partner up with the retailers,” said Sari Kaganoff, general manager of consulting at Rock Health. “At the same time, there’s a lot of opportunity, we believe, for pharma companies to use retailers for clinical trials.”
    • CVS will fully exit the clinical trials business by the end of 2024, winding down the business in phases and working with trial sponsors to ensure patients continue to receive care. 

From the Rx coverage front —

  • The Wall Street Journal informs us,
    • Kristen Ireland struggled with bulimia nervosa for years, working with a therapist and taking medications for anxiety and depression.
    • It wasn’t until her psychiatrist prescribed Victoza, a diabetes medication that works much like Ozempic, Wegovy and Mounjaro, that her binges and purges faded away.
    • “I feel free now,” said Ireland, 27 years old, who manages sports-merchandise stores in Jackson Hole, Wyo. 
    • Treating eating disorders is another potential application for a class of drugs that has taken the weight-loss world by storm. The drugs, synthetic versions of the GLP-1 hormone that act on appetite centers in the brain and gut, have helped patients lose 15% of their body weight on average
    • Some studies and the experience of doctors in the field suggest they could also help people stop binge eating.
  • CBS News discusses the side effects of these new weight loss drugs.

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

From Washington, DC —

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

From the public health front —

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

From the research front, BioPharma Dive reports,

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