Monday Roundup

Rx coverage

Monday Roundup

David Ermer–CMS, COVID-19 vaccine, Medical / Rx research, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

Happy Bobby Bonilla Day!

“The calendar has turned to July 1, and that means one thing: It’s time for Mets fans everywhere to wish each other a Happy Bobby Bonilla Day! Why? On Monday, 61-year-old Bobby Bonilla will collect a check for $1,193,248.20 from the New York Mets, as he has and will every July 1 from 2011 through 2035.”

The FEHBlog is not a Mets fan. It’s a fun story.

From Washington, DC,

  • The American Hospital Association News reports,
    • “Changes to the Centers for Medicare & Medicaid Services’ Hospital Price Transparency Rule took effect July 1. Going forward, hospitals are required to use a standard machine-readable file format, which includes some new data elements, such as the negotiated rate methodology and an accuracy and completeness statement.”  
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced more than $200 million to support 42 programs across the country aimed at improving care for older Americans, including those experiencing Alzheimer’s disease and related dementias.”
    • “HRSA’s Geriatrics Workforce Enhancement Program will train primary care physicians, nurse practitioners, and other health care clinicians to provide age-friendly and dementia-friendly care for older adults.  The program also focuses on providing families and other caregivers of older adults with the knowledge and skills to help them best support their loved ones.” * * *
    • “For a full list of award recipients, visit: https://bhw.hrsa.gov/funding/apply-grant/gwep-awardees.”
  • The Washington Post lets us know,
    • “The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals, citing the company’s refusal to take down about two dozen patents for its asthma and COPD inhalers, according to confidential agency documents reviewed by The Washington Post.
    • “The FTC last week sent a civil investigative demand — effectively a subpoena — ordering Teva to provide internal communications, analysis and financial data related to the contested patents listed in a federal registry known as the Orange Book. The agency has argued that pharmaceutical companies such as Teva have wrongly made minor tweaks to their products to keep patents in the Orange Book and fend off generic competition. Teva charges hundreds of dollars for inhalers in the United States that the company sells for a fraction of the price overseas.
    • “Teva has until July 24 to cooperate with the FTC’s demand.”
  • The New York Times reports,
    • “The Supreme Court on Monday gave companies more time to challenge many regulations [under the Administrative Procedure Act], ruling that a six-year statute of limitations for filing lawsuits begins when a regulation first affects a company rather than when it is first issued.
    • “The ruling in the case — the latest in a series of challenges to administrative power this term — could amplify the effect of the blockbuster decision last week overturning a foundational legal precedent known as Chevron deference, which required federal courts to defer to agencies’ reasonable interpretations of ambiguous statutes. That decision imperils countless regulations, particularly on the environment, and advances a longstanding goal of the conservative legal movement.
    • “The vote was 6 to 3, split along ideological lines. Justice Amy Coney Barrett, writing for the conservative majority, rejected the government’s argument that the time limit to sue begins when an agency issues a rule.
    • FEHBlog note — The Supreme Court has completed its October 2023 term.

From the public health and medical research front,

  • Per an NIH press release,
    • “A Phase 1 trial testing the safety of an experimental nasal vaccine that may provide enhanced breadth of protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19, is now enrolling healthy adults at three sites in the United States. The National Institutes of Health (NIH) is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases.” * * *
    • “The study aims to enroll 60 adult participants, ages 18 to 64 years old, who previously received at least three prior doses of an FDA-approved or -authorized mRNA COVID-19 vaccine. The trial sites are Baylor College of Medicine, Houston; The Hope Clinic of Emory University, Decatur, Georgia; and New York University, Long Island. Hana M. El Sahly, M.D., at the Baylor College of Medicine Vaccine Research Center, is leading the study.” * * *
    • “More information about the trial is available at clinicaltrials.gov using the identifier NCT06441968.”
  • MedPage Today informs us,
    • “Getting an mRNA COVID-19 shot during the first trimester of pregnancy didn’t lead to an increased risk of major structural birth defects, a multisite retrospective cohort study found.
    • “Major structural birth defects occurred in 1.48% of infants after a first-trimester vaccination and in 1.41% of those without a first-trimester vaccination (adjusted prevalence ratio 1.02, 95% CI 0.78-1.33), Elyse Kharbanda, MD, MPH, of the HealthPartners Institute in Bloomington, Minnesota, and colleagues reported in JAMA Pediatrics.”
    • “Additionally, secondary analyses revealed that there were no significant differences between groups when birth defects were grouped by organ system.
    • “These findings should provide reassurance to pregnant people and their obstetric care practitioners,” the authors concluded.”
  • The Washington Post relates,
    • “People with leg amputations were able to control their prosthetic limbs with their brains in a significant scientific advance that allows for a smoother gait and enhanced ability to navigate obstacles, according to a study published Monday in the journal Nature Medicine.
    • “By creating a connection between a person’s nervous system and their prosthetic leg, researchers at the K. Lisa Yang Center for Bionics at MIT and Brigham and Women’s Hospital paved the way for the next generation of prostheses.
    • “We were able to show the first full neural control of bionic walking,” said Hyungeun Song, first author of the study and a postdoctoral researcher at MIT.”
  • Beckers Hospital Review points out,
    • “The national supply of the cancer drug cisplatin now exceeds demand, FDA Commissioner Robert Cailiff, MD, said June 28. 
    • “The drug, which treats multiple cancers, had been in shortage since February 2023. The shortage occurred after the FDA halted imports from Intas Pharmaceuticals’ manufacturing plant in India in late 2022 due to quality issues. In May 2023, 70% of cancer centers lacked sufficient cisplatin supply, according to a report from the National Comprehensive Cancer Network. 
    • “Low supplies of cisplatin and other cancer drugs have complicated treatments for many patients, with some U.S. cancer centers still struggling to maintain adequate supplies.” 
  • The Washington Post and Consumer Reports identify cures for constipation.
  • BioPharma Dive calls attention to ten clinical trials to watch in the second half of 2024.

From the U.S. healthcare business front,

  • Mercer explains why healthcare cost – and volatility – has CFOs worried. 
    • “As we head towards the third quarter of 2024, top concerns around health programs are affordability for both employees and employers, the potential impact of GLP-1s on cost trends, and the increased volatility in claims. For fully insured sponsors, claims volatility makes it difficult to predict cost from year to year, while self-insured sponsors may also experience the effects of claims volatility within a given year. Healthcare trends have been impacted by broader economic inflationary pressures with a lag, and the environment will remain challenging for some time to come. While we expect medical cost trends to be similar to last year’s, we see growing cost pressure from prescription drugs, which account for approximately one-third of total health plan costs.”
    • The article compiles Mercer’s findings from a survey of eighty CFOs.  
  • Beckers Hospital Review notes,
    • “If current trends continue, Michael Murphy, PharmD, said all payers will come to recognize pharmacists as healthcare providers by the end of the decade. 
    • “Dr. Murphy, the American Pharmacists Association’s adviser for state government affairs, said there has been “an explosion” of health plans increasing coverage for pharmacists’ services. In a June 26 blog post, he said momentum is building among commercial plans and state Medicaid fee-for-service and managed care plans. 
    • “Pharmacists are being enrolled as providers in much the same way that health plans enroll physicians, nurse practitioners and physician assistants,” Dr. Murphy said. “Pharmacists are also billing for their services in similar ways as other providers. Often, pharmacists submit the same billing codes that other healthcare providers submit for a comparable visit.”
  • STAT News reports,
    • “For 15 years, a formidable CEO-CFO duo often called “the two Tonys” ushered their St. Louis-based health system through a period of explosive growth, adding hospital after hospital until it became one of the country’s biggest health systems.
    • “The year after former CEO Anthony Tersigni and former finance chief Anthony Speranzo stepped down, their sprawling empire of roughly 140 hospitals underwent the ultimate stress test: the Covid-19 pandemic. Ascension has lost almost $4 billion on operations from fiscal 2020 through fiscal 2023, triggering deals to offload almost 30 hospitals. Just last week, Ascension said it would sell its remaining five hospitals in Alabama.
    • “They are going hard on the expense side,” said Stephen Infranco, managing director and head of the nonprofit health care team at S&P Global. “It’s a wait and see approach to how successful it is.”
    • “In a statement, Ascension spokesperson Sean Fitzpatrick said reviewing the hospital portfolio is an ongoing exercise at Ascension. “We are constantly looking for opportunities to prudently prune and grow our care delivery system in an effort to best serve patients in our communities,” he said.”
  • Per Fierce Healthcare,
    • “Amedisys, a large home health provider, plans to divest a number of care centers to an affiliate of VitalCaring Group in advance of its planned merger with UnitedHealth Group later this year.
    • “VitalCaring also acquired some UnitedHealth Group care centers in the deal, according to a filing with the U.S. Securities and Exchange Commission on Friday.
    • “The completion of the divestiture hinges on the closing of the merger between Amedisys and UnitedHealth Group, which is expected to close in the second half of 2024, Amedisys said in the SEC filing.” * * *
    • “This news is unsurprising and relatively on schedule,” wrote Matt Larew, a healthcare research analyst and partner at William Blair in an analyst note. “In May, a report originally surfaced that UnitedHealth and Amedisys were working with regulators on a divestment package of over 100 locations and a short time after it was reported that VitalCaring had emerged as the buyer.”
  • Per Healthcare Dive,
    • “Health technology startup Fabric is acquiring Walmart’s telehealth assets as the retailer exits its healthcare delivery business. 
    • “Fabric, which offers patient intake, care navigation and telehealth services, said Friday it purchased Walmart’s MeMD for an undisclosed amount. MeMD, which Walmart acquired in 2021, provides virtual behavioral, urgent and primary care benefits for 30,000 corporate partners and five million members.
    • “Walmart said in April it would close its healthcare business, citing a challenging reimbursement environment and growing operational costs that limited profitability.”
  • and
    • “Amazon is folding its telehealth marketplace into primary care chain One Medical, unifying its healthcare delivery services under a single brand — and placing One Medical in front of the eyes of engaged telehealth customers, potentially creating a new source of subscriptions.
    • “Amazon is rebranding the marketplace, previously called Amazon Clinic, to Amazon One Medical Pay-Per-Visit. The service, which automatically connects patients to a provider via virtual video or messaging for a flat fee, is also getting more affordable.
    • “Messaging visits are $29, down from around $35, and video visits are $49, down from $75.”

A Busy Thursday

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • STAT News tells us,
    • “A House committee overwhelmingly passed four bills on Thursday that would expand Medicare coverage of obesity drugs and cancer screening blood tests and place guardrails around Medicare’s discretion in covering drugs and devices approved by the Food and Drug Administration.
    • “[By a 36-4 bipartisan vote],the House Ways & Means Committee passed obesity drug coverage legislation that would offer a limited pathway for adults 65 and older to get their weight loss drugs paid for by Medicare. Right now, Medicare is prohibited from covering medications used for weight loss, like Wegovy and Zepbound. 
    • “However, the new plan is significantly more restrictive than prior proposals. It’s primarily targeted at making sure that people currently taking weight loss drugs don’t get kicked off when they enter the Medicare program, such as by turning 65.” * * *
    • “Another bill that gained even more support would expand Medicare coverage of cancer screening. The legislation passed on a 38-0 vote. 
    • “Medicare is allowed to pay for FDA-approved tests that diagnose diseases, but it doesn’t cover tests that simply screen healthy people for cancer. The bill would open the door for Medicare to pay for cancer screening tests, including Grail’s Galleri.” 
  • MedPage Today informs us,
    • “Value-based care — in which medical practices are paid based on the value of their care, not on volume — is a good idea but the Centers for Medicare & Medicaid Services (CMS) need to improve its implementation, doctors and a healthcare executive told members of the House Ways & Means Health Subcommittee.
    • “I am a proponent of the need to move to value-based care, improving quality while decreasing wasteful spending and ensuring access,” Robert Berenson, MD, an institute fellow at the Urban Institute in Washington, D.C., said at Wednesday’s subcommittee hearing on improving value-based care for patients and providers. “However, I believe that value-based payment as a mechanism to promote better care delivery has gotten off track and needs a thorough reevaluation and reformulation.”
  • Fierce Pharma relates,
    • “Leading health legislators say they are focused on reducing prescription drug prices while minimizing unintended consequences of the Inflation Reduction Act (IRA).
    • “House Rep. Scott Peters, D-California, and Rep. Mariannette Miller-Meeks, R-Iowa, shared their priorities during a program put on by The Hill and the Alliance for Aging Research.
    • “Peters stressed that the drug manufacturing industry needs to stay in the U.S., unlike how the country let chip manufacturing business slip away and go offshore. He also wants lawmakers to budget healthcare expenditures differently.
    • “Innovation might cost more money upfront, even if it saves money down the line,” he said. “In the Budget Committee, which I also serve on, we’re talking about how to think about balancing the budget over time. If we don’t think about the future costs of all these diseases, as part of that calculation, I think we’re going to miss the mark.”
  • Per CMS fact sheets,
    • On June 26, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) proposed rule, which would update Medicare payment policies and rates for Home Health Agencies (HHAs). These changes can support timely admission to home health services, which has demonstrated improvements for patient outcomes and reducing risk of hospital readmissions. 
  • and
    • “On June 27, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule 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, 2025.
    • “For CY 2025, CMS is proposing to increase the ESRD PPS base rate to $273.20, which would increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.2%.”
  • HHS’s Office for Civil Rights announced,
    • “At the HHS Office for Civil Rights, we believe patient privacy is essential to ensuring high quality reproductive health care. HHS OCR is encouraging HIPAA covered entities and business associates to begin implementing the new HIPAA Privacy Rule to Support Reproductive Health Care Privacy to help protect patient privacy and ensure compliance later this year. To aid in this, we have compiled resources for both community members and HIPAA Covered Entities or Business Associates. 
      • “For resources to help communicate with stakeholders and community members click here.
      • “For a fact sheet summary of the rule click here (en español).
      • “To hear directly about the rule from Director Melanie Fontes Rainer click here (en español).
      • “To view a recorded briefing by Deputy Director for Health Information Privacy, Data and Cybersecurity Timothy Noonan click here.
      • “For a model attestation for a requested use or disclosure of protected health information potentially related to reproductive health care click here.
    • “The effective date of the Final Rule was June 25, 2024. This is the date that HIPAA covered entities and their business associates may begin implementing the new requirements. Covered entities and business associates are not required to comply with the new requirements until December 23, 2024, except for the new changes to the HIPAA Notice of Privacy Practices which has a compliance date of by February 16, 2026.”
  • Healthcare Dive lets us know,
    • “The U.S. Supreme Court ruled 6-3 on Thursday to allow Idaho doctors to perform abortions to stabilize a patient’s life and health. 
    • “However, the court declined to take up the fundamental legal question underlying the case: whether a federal law mandating hospitals provide medical services during emergencies [known as EMTALA] supersedes near-total state abortion bans.
    • “It is the court’s first ruling on statewide abortion restrictions since Roe v. Wade was overturned in 2022, ending the constitutional right to abortion in the United States.”
  • CMS observed,
    • “CMS’ first responsibility is to the people we serve, including anyone who steps into the emergency department of a Medicare-participating hospital. If any individual believes their EMTALA rights have been violated, they should continue to report the circumstances to CMS or their state survey agency. To the maximum extent permitted by law, we will continue to investigate complaints and hold hospitals accountable to provide the emergency stabilizing treatment that EMTALA has required for decades.”
  • The Wall Street Journal reports,
    • “The Supreme Court rejected a bankruptcy plan for OxyContin-maker Purdue Pharma that would have allocated billions of dollars from members of the wealthy Sackler family to combat opioid addiction in exchange for shielding them from civil lawsuits over their alleged role in fueling the drug epidemic.
    • “The 5-4 decision marks a victory for the minority of opioid victims who voted to reject the settlement plan because they want to continue pressing lawsuits against the Sackler family members who own Purdue, and a loss for the majority of opioid victims and state and local governments who voted to accept it.”
    • “The high court said U.S. bankruptcy law doesn’t allow for a release of the Sacklers’ legal liabilities stemming from their ownership of Purdue when not all opioid-related plaintiffs have accepted the terms offered by the company’s family owners, whose wealth has been estimated at $11 billion.” * * *
    • “Thursday’s ruling—among the highest-profile bankruptcy decisions ever from the high court—weakens the ability of corporations and their insiders to use bankruptcy to resolve mass litigation alleging they harmed consumers. 
    • “The Sacklers didn’t file for bankruptcy themselves and didn’t agree to place “anything approaching their full assets on the table” for distribution to opioid victims, [Justice Gorsuch] wrote [for the Court’s majority]. “Yet they seek a judicial order that would extinguish virtually all claims against them for fraud, willful injury, and even wrongful death, all without the consent of those who have brought and seek to bring such claims,” he wrote. 
    • “Nothing in U.S. bankruptcy law authorizes that outcome, [Justice] Gorsuch said.
  • Fierce Pharma adds,
    • “The Supreme Court decision sends the case back to bankruptcy court for future deliberations, according to a statement from Connecticut Attorney General William Tong.”

From the public health and medical research front,

  • The New York Times reports,
    • “All Americans ages 6 months and older should receive one of the new Covid-19 vaccines when they become available this fall, the Centers for Disease Control and Prevention said on Thursday.
    • “The recommendation comes as the nation faces a summer wave of Covid, with the number of infections rising in at least 39 states and territories.
    • “Most Americans have acquired immunity against the coronavirus from repeat infections or vaccine doses, or both. The vaccines now offer an incremental boost, remaining effective for only a few months as immunity wanes and the virus continues to evolve.
    • “Still, across every age group, a vast majority of Americans who were hospitalized for Covid did not receive one of the shots offered last fall, according to data presented at a meeting on Thursday of the C.D.C.’s Advisory Committee on Immunization Practices.
    • “Dr. Mandy Cohen, the agency’s director, accepted the unanimous advice of the panel on Thursday to recommend another round of immunizations.”
  • The NIH Director writes in her blog,
    • “Cancer arises when changes in genes that normally control cell division lead to unchecked growth at the expense of healthy tissues. One of the most common genetic alterations across human cancers—occurring in 95% of pancreatic cancers but also many non-small cell lung cancers, colorectal cancers, and others—is in a gene known as KRAS. While promising new treatments targeting KRAS to shrink cancerous tumors have recently gained approval, less than 40% of pancreatic cancers respond to treatment with KRAS inhibitors for reasons that aren’t well understood.
    • “There’s much more to learn about how KRAS spurs cancer growth—and how KRAS-mutant cancers resist treatment with existing KRAS inhibitors. To address this need, researchers behind two studies in Science have established the most comprehensive molecular portrait yet of the workings of KRAS and how its many downstream impacts may influence outcomes for people with pancreatic cancer. The findings could lead to new treatment approaches, including ways to potentially guide treatment for individuals with pancreatic cancer, the third leading cause of cancer-related death in the U.S.
    • “These studies, supported in part by NIH, come from a team led by Channing Der  and Adrienne Cox, together with Jeffrey Klomp, Clint Stalnecker, and Jennifer Klomp, at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill. The researchers were inspired in part by the Food and Drug Administration’s recent approval of treatments that block a mutated version of KRAS that drives many pancreatic cancers. The team was also motivated by the realization that many patients whose cancers initially respond to the new treatments relapse rather quickly as the cancers find ways to reactivate underlying growth pathways.” * * *
    • “Importantly, the researchers found that the molecular signatures they’ve uncovered may predict tumor responses in patients treated with KRAS inhibitors or ERK inhibitors. Based on their findings, they suspect that the reason so many pancreatic cancers don’t respond to KRAS inhibitors may be because the drugs simply don’t block KRAS well enough—and not because the cancers no longer depend on KRAS signals for their growth. The researchers suggest it may be beneficial to monitor these underlying molecular pathways in patients to better understand treatment outcomes and guide treatment decisions.
    • “The team plans to continue exploring the role of these and other important drivers of cancer growth and treatment resistance. Ultimately, their goal is to help advance the development of the next generation of KRAS inhibitors that will work even better for many more people with pancreatic or other KRAS-driven cancers.”
  • Health Day notes,
    • “A full third of American adults take multivitamins, despite prior studies suggesting they do little to boost health.
    • “Now, a study involving almost 400,000 people finds zero benefit from multivitamin use in helping folks live longer.
    • “Among people “without a history of major chronic diseases, we did not find evidence to support improved longevity among healthy adults who regularly take multivitamins,” concluded a team led by Erikka Loftfield. She’s with the Division of Cancer Epidemiology and Genetics at the U.S. National Cancer Institute (NCI).
    • “Her team published its findings June 26 in the journal JAMA Network Open.
  • Healio calls to our attention a study finding
    • “Alcohol intake of more than 12 g per day was associated with increased risk for hypertension.
    • “Hypertension risk plateaued at higher levels of alcohol intake for men, but risk continued to rise for women.”
  • STAT News offers a detailed article titled “By the numbers: America’s alcohol-related health problems are rising fast.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Walgreens is pulling back its focus on healthcare services after the strategic shift failed to bolster the struggling retailer’s financial health.
    • “Walgreens plans to reduce its stake in value-based medical chain VillageMD, and will no longer be the company’s majority owner, CEO Tim Wentworth told investors on a Thursday morning call after announcing third quarter earnings below analyst expectations.
    • “Walgreens also plans to close a “significant portion” of its roughly 8,700 stores in the U.S., Wentworth said. The company didn’t share a specific figure, but said it is reviewing one-quarter of its stores that are underperforming financially. Walgreens has already closed hundreds of stores over the past few years.” * * *
    • “Walgreens plans to launch a retail pharmacy action plan to improve customer experience in its stores, better align its pharmacy and healthcare businesses and focus on reliable products in areas like women’s health, Wentworth said.
    • “The company is also in discussions with health insurers and pharmacy benefit managers to change how its pharmacies are paid, to create more stability in a challenging reimbursement environment.”
  • Modern Healthcare reports,
    • “At-home emergency care is gaining momentum — and could cost millions less — but reimbursement challenges create an access barrier for some patients.
    • “Deploying healthcare in patients’ homes gained traction during the COVID-19 pandemic as a way to ease overcrowding at hospitals and prevent the virus from spreading. Emergency department care at home lets patients bypass the waiting room through referrals from hospitals or primary care providers if they determine patients do not have life-threatening illnesses or injuries. While many private insurers reimburse for such care, traditional fee-for-service Medicare and Medicaid do not pay for it as a stand-alone service.
    • “Emergency department-at-home programs deploy paramedics or nurses to check vital signs, draw blood and take x-rays with portable imaging devices. Physicians supervise the visits via telehealth, then refer patients to primary care providers for further treatment or to hospital emergency departments if more complex care is needed.
    • “Healthcare technology company Medically Home and primary care provider Atrius Health, a division of UnitedHealth Group’s Optum Health, offer emergency department-care-at-home through a partnership in the Boston area. A study they published last week in the New England Journal of Medicine found more than 83% of 3,668 patients who received emergency care at home over two years did not require a trip to the hospital, saving Atrius approximately $4.5 million.
    • “Medically Home launched its service in 2020 and has served approximately 7,000 patients through contracts with three provider groups, including Atrius. The primary care provider has value-based care contracts with most of its patients and takes on the full risk for their care.”
  • FEHBlog observation: Intriguing!
  • Per Fierce Healthcare,
    • “Nineteen rural Minnesota hospitals and their 50-plus clinics have banded together to form a clinically integrated network (CIN) serving more than 750,000 people.
    • “The so-called Headwaters High-Value Network, announced Thursday, stitches the independent hospitals’ services together so that Minnesotans can coordinate their care across care sites. Together, the member groups employ about 9,000 people and bring in $1.3 billion of annual net revenue.
    • “Members of the network also said the approach will help their hospitals control rising care costs through reduced administrative burden and shared services. The CIN said it is “in discussions” with other interested rural Minnesota hospitals and “expects to grow.”
  • Beckers Hospital Review identifies the ten best states for hospital experience. Nevada leads the pack.
  • Beckers Hospital Review adds,
    • “Mark Cuban Cost Plus Drug Co. will serve as a wholesale drug distributor for all 71 hospitals affiliated with Community Health Systems, the organizations announced June 27. 
    • ‘Cost Plus Drugs launched the wholesale services in early 2024, but for the first time, the company is rolling out the offering to a large health system.
    • “The pharmaceutical company has direct relationships with 38 of the 40 largest generic manufacturers and multiple secondary distributors, according to Cost Plus Drugs’ CEO and co-founder, Alex Oshmyansky, MD, PhD.

Midweek update

David Ermer–CDC, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Derek Lamar on Unsplash

Happy Juneteenth and RIP Willie Mays.

  • Federal News Network lets us know,
    • “Especially in the federal government, change often happens slowly. But the Office of Personnel Management said it’s seeing early indications that its efforts to reform federal recruitment are starting to pay off.
    • “OPM’s initiatives over the last couple years, such as banning the consideration of salary history, creating a job portal for internship openings, and broadening eligibility for paid internships through the Pathways Program, all aim to open the doors to more candidates and make the hiring process more equitable.
    • “Even though the larger impacts of those changes are likely still further down the road, OPM Acting Director Rob Shriver said signs are pointing in the right direction, especially for OPM’s efforts centered on improving recruitment and retention of younger employees.”Even though the larger impacts of those changes are likely still further down the road, OPM Acting Director Rob Shriver said signs are pointing in the right direction, especially for OPM’s efforts centered on improving recruitment and retention of younger employees.
    • “I do think what we’re seeing is a renewed and increased interest in federal job opportunities by early-career talent,” Shriver told Federal News Network Tuesday during an event for federal interns hosted at OPM’s headquarters office.”

From the public health and medical research front,

  • MedPage Today informs us,
    • “Increasingly, research is coming out in favor of drinking as little as possible — but the exact level of risk hasn’t been made clear, according to the New York Times.
    • “A recent meta-analysis of 107 studies found that no amount of alcohol consumption improved health. It had come after one scientist noticed that many alcohol studies had a fundamental flaw: they included ex-drinkers in their “abstainers” group, who may have stopped drinking because of illness.
    • “By comparison, moderate drinkers looked healthier, according to the Times. The reevaluation found a statistically significant increase in all-cause mortality for women who drank under two drinks a day, and men who had more than three. Another study found that even one or two drinks daily can shrink the brain.
    • “So how should people think about their risk? Someone who has two drinks a week could shave a week off their life, and seven drinks a week could shave off 2.5 months, a researcher told the Times. But consume five drinks a day, and it may cost 2 years.
  • STAT News reports,
    • “For members of a large extended Colombian family, an early Alzheimer’s diagnosis is practically a grim guarantee. But new research further supports the idea that a rare genetic mutation can delay the devastating disease’s onset. * * *
    • “The findings, published on Wednesday in the New England Journal of Medicine, come five years after this research team identified a woman in the Colombian family who had two copies of the Christchurch mutation and developed Alzheimer’s 30 years later than expected. That finding suggested that the mutation had protected her, but outside researchers pointed out that it was hard to say for certain based on a single person. And they added that the mutation’s putative protection would be more convincing if researchers could show a more modest disease delay in people with one copy of the variant, found in a gene coding for a form of the protein apolipoprotein E, or APOE.
    • “The Alzheimer’s field has long been focused on removing amyloid plaques to slow disease, and the Food and Drug Administration is widely expected to approve one such drug from Eli Lilly after approving an anti-amyloid therapy from Biogen and Eisai. But the new study adds to growing evidence that supports targeting APOE. Some efforts to develop drugs that mimic the Christchurch mutation’s effects are already underway. The new study’s senior author, Joseph F. Arboleda-Velasquez, a cell biologist at Mass Eye and Ear, said these latest findings add fresh urgency to that work.”
  • Medscape adds,
    • “Healthy behaviors have been linked to a lower risk for Alzheimer’s disease (AD) but may also benefit patients already diagnosed with mild cognitive impairment (MCI) or early AD, new research suggested.
    • “After 20 weeks, patients following an intensive multimodal lifestyle intervention showed significant improvements across three measures of cognition and function and less progression on one measure when compared with usual care.”
  • Forbes tells us,
    • “Health officials across the continental U.S. are starting to warn about the annual return of West Nile virus, a potentially lethal human disease without treatments or vaccines that is rearing its head earlier than usual as the changing climate makes the environment more hospitable for the mosquitoes that spread it.”

From the U.S. healthcare business front,

  • MedCity News offers an interview with Erin Fox, PharmD, MHA, who has tracked drug shortages for more than 20 years and sees no easy solutions for what has become a record run.
    • “Q: Are there any signs that this is letting up?
    • “A: Unfortunately, no. We haven’t necessarily solved some of the root causes.
    • “We have, overall, relatively few manufacturers. [FDA] halted inspections during COVID. Now they’re back, at factories that maybe haven’t been inspected for 5 or 6 years. They’re finding some things to fix. Those fixes can take anywhere from 6 to 18 months for production to get fully back on schedule.
    • “Meanwhile, other companies don’t necessarily have the capacity to ramp up production to make up the difference.
    • “It’s not the FDA’s fault. We want them to find those quality deficits. But when FDA goes out looking all at once, it can be pretty disruptive.
    • “Q: What are the typical drugs that land on the shortage list?
    • “A: Generic, injectable hospital drugs, or older drugs. They are usually pretty low cost. There’s not a lot of resilience in the supply chain for another company to make up the difference.
    • “We saw all those chemotherapy shortages last year in part because a large factory in India, (the FDA) found quality problems there. They made a large amount of the U.S. supply. The other companies were unable to quickly make up the difference.
  • Beckers Hospital Review identifies five drugs that recently wound up on the shortage list.
  • MedCity News share “Nine Requirements for an Optimal Genetic Test Benefit Program” under health plan coverage.
    • Why? “An estimated 180,000 genetic tests are on the market, with an average of 10 new tests added daily. CPT coding has yet to keep up. Only about 500 CPT codes are used for 360 times the number of tests. The resulting system is slow, inefficient, expensive, and prone to waste, fraud, and abuse. Health plans need management programs designed specifically for genetic testing, which will only grow in volume and complexity.”
  • Fortune via Yahoo Finance offers an interview with “Tilak Mandadi [who] joined CVS in 2022 as EVP of ventures and chief digital, data, analytics and technology officer at CVS. [At that time,] there were separate teams running data, analytics, IT, and other technology functions. One of his earliest projects was to combine all of those functions into an integrated organization. He also appointed chief digital technology officers to oversee each of the company’s divisions.” Check it out.

Tuesday Tidbits

David Ermer–ACA, AHRQ, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healthcare Dive lets us know,
    • “The rate of uninsured Americans is expected to rise over the next decade, largely erasing coronavirus pandemic-era gains as subsidies for plans in the Affordable Care Act marketplaces and policy stipulations keeping low-income people on Medicaid expire, according to new projections from the Congressional Budget Office.
    • “This year, just 7.7% of Americans, or 26 million people, are uninsured, according to the CBO. In comparison, 10.3% or 33.2 million Americans were uninsured in 2019.
    • “Yet an estimated 1.7 million people — mostly working-age adults — will become uninsured on average every year until the uninsured rate swells to 8.9% in 2034, the CBO projects.”
  • Modern Healthcare reports,
    • “Novant Health ended its 16-month pursuit of a $320 million deal to acquire two North Carolina hospitals from Community Health Systems after a federal appellate court on Tuesday dealt it a harsh blow.
    • “The U.S. Court of Appeals for the Fourth Circuit hit Novant’s proposed acquisition of Mooresville-based Lake Norman Regional Medical Center when a panel voted 2-1 to grant the Federal Trade Commission’s motion to stop that proposal pending appeal. Lake Norman Regional Medical Center was one of two hospitals Novant sought to purchase from Community Health Systems, along with Statesville-based Davis Regional Medical Center.
    • “A Novant spokesperson said the health system doesn’t see a way to finalize the deal given the FTC’s “continued roadblocks.” Winston-Salem, North Carolina-based Novant announced plans in February 2023 to acquire the two hospitals from Franklin, Tennessee-based Community Health Systems.”
  • Beckers Hospital Review tells us,
    • “Spending on drugs purchased at discounted 340B prices across all participating facilities went up 19% annually between 2010 and 2021, according to a June 17 report from the Congressional Budget Office. 
    • “Established by Congress in 1992, the 340B drug pricing program allows qualifying hospitals and clinics that treat low-income and uninsured patients to purchase some drugs at a discounted rate of between 25% and 50% off their normal price.
    • “Enrollment in the 340B program has drastically increased in recent years, driving up spending and also leading to more disputes between covered entities who need to obtain affordable medications for uninsured or underinsured patients and drugmakers who need to protect company profits and resources. 
    • “Cancer drugs, anti-infective agents, and immunosuppressants accounted for 70% of total 340B spending in 2021 — up from 58% in 2010 — according to data from the Health Resources and Service Administration, which was analyzed by the Congressional Budget Office.” 
  • The U.S. Preventive Services Task Force today gave a B grade to a recommended that clinicians provide or refer children and adolescents 6 years or older with a high body mass index (BMI) (≥95th percentile for age and sex) to comprehensive, intensive behavioral interventions.
  • STAT News adds,
    • “On Tuesday, the United States Preventive Services Task Force issued recommendations encouraging clinicians to provide or refer children and adolescents 6 years or older with a high body mass index to comprehensive, intensive behavioral interventions. That counters last year’s recommendation by the American Academy of Pediatrics to consider obesity drugs for kids 12 and older whose weight tops growth charts, along with encouraging better nutrition, physical activity, and behavioral therapy from age 6 on up. 
    • “The USPSTF called evidence on the benefits of pharmacotherapy “inadequate” due to the small number of studies and limited data on long-term treatment harms, asserting that at least two years of follow-up are needed to gauge the long-term outcomes of drug therapy. That assessment would go beyond BMI to include metabolic health and psychosocial functioning, among other impacts. 
    • “Wanda Nicholson, task force chair and senior associate dean of diversity and inclusion at the George Washington University School of Public Health, said the evidence is clear to support high-intensity behavioral interventions to help children and adolescents lose weight and gain better quality of life. It’s less than clear for the four drugs discussed in the task force’s analysis of current research, she said. The drugs are semaglutide (sold as Wegovy for weight loss/Ozempic for diabetes), liraglutide (Saxenda/Victoza), orlistat (Xenical, Alli), and phentermine/topiramate (Qsymia). * * *
    • “A child’s BMI — a measure many view as flawed — is considered high if it’s at or above the 95th percentile for age or sex. Nearly 20% of U.S. children fall into that category. The prevalence of high BMI rises with age and is higher among Hispanic/Latino, Native American/Alaska Native, and non-Hispanic Black children and adolescents and among children from lower-income families. The dissonance between the USPSTF’s and the AAP’s positions does not address criticism voiced last year over whether the focus on weight instead of health is misplaced. * * *
    • “USPSTF guidance from 2017 focused on screening before intervention, but the new statement instead moves directly to behavioral methods to promote a healthy weight while stopping short of suggesting GLP-1 drugs such as Wegovy. It’s a recognition that screening has become a routine part of primary care.
    • “Those intensive behavioral interventions, intended to help children achieve a healthy weight while improving their quality of life, entail 26 or more hours over one year with a health professional. That might mean physical activity, support for weight-related behavior change, and information about healthy eating.”
  • MedPage Today also discusses today’s USPSTF recommendationj.

From the public health and medical reseaarch front,

  • The International Foundation of Employee Benefit Plans offers guidance on designing the best oncology benefits.
  • The National Cancer Institute posted its latest research highlights.
  • Beckers Hospital Review points out,
    • “Many physicians in obesity medicine have observed a trend among their patients: Those with obesity begin taking a weight loss drug like Wegovy, and their other chronic conditions improve or clear up entirely. “Many physicians in obesity medicine have observed a trend among their patients: Those with obesity begin taking a weight loss drug like Wegovy, and their other chronic conditions improve or clear up entirely. 
    • “As a result, some physicians are embracing an “obesity first” approach in which they treat obesity first with drugs approved for that purpose, anticipating other related conditions, such as high blood pressure and arthritis, will also improve as patients begin to lose weight, according to  a June 19 report from The New York Times. 
    • “We are treating the medical condition of obesity and its related complications at the same time,” Stefie Deeds, MD, an internist and obesity medicine specialist at a private practice in Seattle, told the Times. Dr. Deeds is also an assistant professor at the University School of Washington in Seattle. 
    • “The approach marks a shift from traditional medical practice in which patients with obesity are prescribed a number of medications to treat conditions that often accompany obesity, and advised to make diet and exercise changes. In some cases, patients are happy to be taking a single drug, experts said. 
    • “But there’s no firm consensus that this approach works, and not all physicians are on board. A primary care physician told the Times he leans toward an “obesity last” approach in which he starts by treating obesity-related conditions with drugs known to work for those conditions. If related conditions didn’t improve, only then would he discuss obesity drugs with patients.” 
  • MedPage Today notes, “Adding financial incentives to meal incentive therapies for for teens with severe obesity helped improve weight and body fat, but not cardiometabolic risk factors, a randomized study found.”
  • Per BioPharma Dive,
    • “Intra-Cellular Therapies plans to seek clearance to sell its medicine Caplyta for patients with depression after a second-late stage study of the drug succeeded. 
    • “Caplyta, also known as lumateperone, is currently approved for patients suffering from schizophrenia and depressive episodes associated with bipolar disorder. Intra-Cellular now wants to add major depressive disorder to the list.
    • T”he latest study followed 480 patients already medicated to treat depression. Patients who randomly received Caplyta as an add-on to existing therapy showed a significantly better response on scales that measure depression symptoms compared with participants who received a placebo, Intra-Cellular said Tuesday.”
  • The Washington Post reports for what it’s worth.
    • “Sedentary coffee drinkers had a 24 percent reduced risk of mortality compared with those who sat for more than six hours and didn’t drink coffee, according to the lead author of a study published recently in the journal BMC Public Health.”
    • “The finding, which was not part of the original article, was calculated at The Washington Post’s request and provided by Huimin Zhou, a researcher at the Medical College of Soochow University’s School of Public Health in China and the lead author of the study on coffee and health.”

From the U.S. healthcare business front,

  • MedTech Dive relates,
    • “Boston Scientific has agreed to acquire Silk Road Medical, a maker of stroke prevention devices, for $27.50 per share in cash, or an equity value of about $1.26 billion, the companies said Tuesday.
    • “Silk Road’s products are the only commercially available devices for use during a minimally invasive procedure called transcarotid artery revascularization (TCAR) to treat patients with carotid artery disease, according to Boston Scientific.
    • “We view the deal as largely inexpensive for Boston yet meaningful enough to move the needle on growth in the peripheral interventions business,” J.P. Morgan analyst Robbie Marcus said in a note to clients.”
  • Per Fierce Healthcare,
  • and
    • “Insured patients are often better off buying their generic prescriptions through their health insurance benefits than through Mark Cuban Cost Plus Drug Company, though those without insurance could find cost savings in over a quarter of their pharmacy fills, according to a study published Friday in JAMA Health Forum.
    • “Across a sample of nearly 844 million prescription pharmacy fills logged among 124 generic drugs in 2019, researchers found that nearly 100 million (11.8%) would have reduced out-of-pocket spending for patients if they had been acquired through the billionaire-backed manufacturer and distributor.”

Monday Roundup

David Ermer–CDC, CMS, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The U.S. Office of Personnel Management recently posted new Postal Service Health Benefits Program FAQs concerning its May 2024 proposed rule supplementing existing guidance on that program. The public comment period on that proposed rule is next Monday June 24.
    • Here’s an FAQ on a point that the FEHBlog mentioned but he has not seen in any other publication:
      • While the proposed rule reflects that Medicare Part D-eligible annuitants and their Part D-eligible family members would be automatically group enrolled into the Part D EGWP, it reflects that they may choose to opt out of receiving prescription drug coverage through the PSHB Part D EGWP. This proposed rule provides, consistent with the statute, that the Part D EGWP offered by their PSHB plan is the only PSHB prescription drug benefit available for Part D-eligible PSHB annuitants and their Part D-eligible covered family members. As proposed, Medicare Part D-eligible annuitants and their family members who choose to opt out of or disenroll from the PSHB plan’s Part D EGWP would not have access to prescription drug benefits through their PSHB plan and would not pay a lower premium than those enrolled in the Part D EGWP. An individual who opts out of or disenrolls from the Part D EGWP would be allowed to enroll again during the next open season or an applicable Qualifying Life Event (QLE) if they wish.
  • Federal News Network tells us,
    • “While years in the making, the Office of Personnel Management’s upcoming plans to try to cut down on unneeded health insurance costs will also arrive to open arms from the Government Accountability Office.
    • “Beginning in 2025, OPM is adding stricter eligibility requirements to try to root out ineligible enrollees in the Federal Employees Health Benefits (FEHB) program — something that’s been high on GAO’s radar for at least the last few years. A 2022 GAO report showed that OPM spends up to $1 billion each year on ineligible participants erroneously enrolled in FEHB.
    • “One of the biggest benefit systems in the country, and for decades, nobody checked these things,” Comptroller General Gene Dodaro told lawmakers on the House Oversight and Accountability Committee during a June 13 hearing. * * *
    • “Current FEHB eligibility determination and enrollment is highly decentralized and requires cooperation between nearly 100 employing offices responsible for determining eligibility and enrolling more than 8 million members,” OPM said in April. “If funded, OPM could extend this same central enrollment system to all FEHB enrollments, which would allow OPM to manage and make consistent all FEHB enrollments and remove individuals who cease to be eligible for the program.”
    • “OPM, as part of its fiscal 2025 budget request, is proposing legislation to build a centralized enrollment system for FEHB. With a central database, OPM would be able to more quickly address the problem and avoid the spending errors. That system, if it’s implemented, would be modeled after the centralized system OPM just recently built for the upcoming Postal Service Health Benefits program.”
      • FEHBlog note — While all of this is welcome progress, the most glaring, and as yet unresolved, internal control issue is that OPM reports enrollment and premiums to carriers separately rather than using the HIPAA standard electronic enrollment roster transaction 820 which would allow carriers to reconcile each enrollee with his or her premium payments. Carriers are entitled to this reconcilable information because they hold the insurance risk on these plans. Moreover, shouldn’t we make sure that the enrollee is paying the correct premium before checking family member eligibility?
  • The New York Times reports,
    • “The U.S. surgeon general, Dr. Vivek Murthy, announced on Monday that he would push for a warning label on social media platforms advising parents that using the platforms might damage adolescents’ mental health.
    • “Warning labels — like those that appear on tobacco and alcohol products — are one of the most powerful tools available to the nation’s top health official, but Dr. Murthy cannot unilaterally require them; the action requires approval by Congress.”
  • STAT News adds,
    • “His call to action on Monday was more strident, garnering praise from advocates of stricter social media controls, especially for young people. “Yes, this is a consumer product that is unsafe for children and teens,” wrote NYU social psychologist Jonathan Haidt, a strong proponent of limiting phone time, on X.
    • “But for several experts operating in this field, the type and extent of social media harm exacted on children isn’t quite as clear as Murthy seems to suggest. Indeed, said Michaeline Jensen, a psychologist at the University of South Carolina, Greensboro, there isn’t sufficient evidence to conclude social media is safe — but there isn’t enough to conclude the opposite, either.
  • STAT News also lets us know,
    • “The Food and Drug Administration on Monday approved Merck’s new pneumococcal vaccine for adults 18 and older.
    • “The vaccine, which will be sold under the name Capvaxive, is designed to protect against pneumococcal pneumonia, which hospitalizes about 150,000 adults in the United States every year and kills about 1 in 20 who develop it, according to the National Foundation for Infectious Diseases. * * *
    • “Before Capvaxive can be put into use, it must receive a recommendation from the CDC. The Advisory Committee on Immunization Practices, which advises the CDC on vaccination policy, meets next week for one of its three regularly scheduled meetings. A draft agenda for the meeting shows that a vote on Capvaxive is scheduled for Thursday, June 27.”
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services announced on Monday that is gearing up to end a program that offered financial assistance to providers impacted by the cyberattack on Change Healthcare.
    • “The agency said that the accelerated and advance payment program launched in response to the hack will end on July 12. The initiative sought to ease cash-flow disruptions that were caused by the cyberattack.

From the public health and medical research front,

  • STAT News reports,
    • “The hope for many cancer patients who go through surgery is that they’ll be cured after the surgeon removes the tumor. The question that lingers is whether they got it all out — if the surgery happened in time before cancer cells scattered off of the primary tumor to seed unseen metastases or if some microscopic malignancy was left behind near the original cancer site.
    • “To answer this question, clinicians are increasingly turning to blood tests that detect circulating tumor DNA, known as ctDNA. The idea is that finding tumor DNA in the blood probably means that cancer cells are still growing somewhere in the body, even at a low level. These tests are starting to be used in a variety of cancers — and for the most part, clinicians agree that if the test is positive, the cancer will likely recur. The trouble is that scientists aren’t sure what should happen next.
    • “We are all recognizing that if a patient has detectable circulating tumor DNA, it’s not a question of if the cancer’s coming back, but when,” said Van Morris, a gastrointestinal medical oncologist at MD Anderson Cancer Center. “The field recognizes the power of this tool, but I think there remain many questions of how best do we utilize that in the day-to-day management of patients.”
    • “Some of those questions include whether clinicians should step up the intensity of treatment if patients are positive for ctDNA, whether they should step down treatment if patients are negative for ctDNA, or how long they should treat patients. And if you do any of these things, it’s still not clear if that would have any meaningful impact on patients’ overall survival or quality of life in most settings. The only way to answer these questions will be by confirming hypotheses in prospective randomized trials, which are ongoing.”
  • Per BioPharma Dive,
    • “New data showcase promise, growing pains of CAR-T in autoimmune disease.
    • “While one expert described clinical trial results to date as “unprecedented,” reports of relapses in some patients drew questions about the therapies’ ultimate potential.”
  • The Washington Post and Consumer Reports points out,
    • “Five diet changes that can help lower blood pressure.
    • “Adding potassium and cutting back on alcohol can help reduce the need for meds if you have hypertension, or even prevent it in the first place.”
  • The Washington Post reports,
    • “Born last November, Fern had blood drawn from her heel for North Carolina’s mandatory newborn screening, which tested for more than 60 medical conditions. Nothing was found. That could have been the end of the story. Instead, Tiffany and her husband, Matthew Vogt, a physician and scientist in Durham, decided to take the nonprofit research institute RTI International up on a groundbreaking offer.
    • “Free of charge, parents in North Carolina can have experts conduct a more extensive scan and review their baby’s entire genetic blueprint for 200 different conditions. One is Pendred syndrome, a condition not covered by the standard, more limited newborn screening.
    • “Researchers in North Carolina and New York are studying whether this far more comprehensive approach can save lives and improve children’s health. Two decades after scientists sequenced the first human genome, the two studies reflect the rapid emergence of a new kind of health care called genomic medicine, spawned by that landmark achievement.
    • “Early results show that genome sequencing is identifying conditions not disclosed through the traditional newborn screening required by all 50 states. Since the study in North Carolina began in September 2023, researchers have examined the genomes of more than 1,800 babies; 40 were deemed likely to have medical conditions that were not previously diagnosed. One newborn was flagged as likely to have two previously undiagnosed conditions.
    • “Some of those were for potentially life-threatening conditions,” said Holly Peay, lead investigator for the Early Check program led by RTI International.
    • “Since launching the GUARDIAN program with its collaborators in September 2022, New York State has sequenced the genomes of more than 10,000 babies; 299 tested positive for one of the 450 conditions the state has focused on.
    • “For one child, it was even lifesaving,” said Wendy Chung, head of pediatrics at Boston Children’s Hospital, who is leading New York’s study.”
  • The National Institutes of Health announced,
    • “The prevalence of chronic hypertension in pregnancy in the United States doubled from 2007-2021, but only about 60% of those with the potentially life-threatening condition were treated with antihypertensive medications, according to a National Institutes of Health (NIH)-supported study of nearly 2 million pregnancies. The study, which was funded by NIH’s National Heart, Lung, and Blood Institute (NHLBI), did not explore the reasons for the increase, but rising maternal age, growing obesity rates, and other factors likely played a role, according to researchers. The findings were published today in the journal Hypertension.
    • “These findings are deeply concerning because of the high rate of U.S. maternal mortality, which is linked to chronic hypertension in pregnancy,” said study lead Stephanie Leonard, Ph.D., an epidemiologist at Stanford University School of Medicine in California. “Despite the availability of safe and effective treatments for chronic hypertension, the study speaks to an urgent need for improvement in care for this serious condition.” * * *
    • “To manage hypertension during pregnancy, experts recommend that women check their blood pressure at home and keep it under control, visit with a doctor often, and take antihypertensive medications as prescribed.”
  • Per a Substance Abuse and Mental Health Services Administration press release,
    • “Researchers from the Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA), Centers for Medicare & Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC) found that among a cohort of 137,000 Medicare beneficiaries who experienced a nonfatal overdose in 2020, almost 24,000 (17.4%) experienced a subsequent nonfatal overdose, and about 1,300 (1%) died from overdose in the following year. Results were published today in JAMA Internal Medicine, identifying both effective interventions and significant gaps in care.
    • “People who have experienced one overdose are more likely to experience another,” said Miriam E. Delphin-Rittmon, Ph.D., HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “But we found that when survivors received gold-standard care such as medications for opioid use disorder and naloxone, the chances of dying from an overdose in the following year drop dramatically. In short, medications for opioid use disorder, opioid overdose reversal medications, and behavioral health supports save lives.”
    • “The study identifies effective, lifesaving interventions following initial nonfatal overdoses. The odds of dying from a subsequent lethal overdose decreased among cohort members who received methadone (58% lower odds), buprenorphine (52% lower odds), or behavioral health assessment or crisis services (75% lower odds). The risk of overdose mortality among those who filled a prescription for naloxone was also reduced by 30%.
    • “However, significant gaps in care were also noted. Only 4.1% of the cohort received medications for opioid use disorder (MOUD), and only 6.2% filled a prescription for naloxone, commonly known as Narcan, despite these being gold-standard interventions. Beneficiaries receiving MOUD waited a mean of 72 days between their nonfatal overdose and receiving medication.”
  • STAT News reports,
    • “E-cigarettes were about as effective at helping people quit smoking as the gold-standard pharmaceutical drug, varenicline, according to a clinical trial published Monday in JAMA Internal Medicine.
    • “The trial randomized 458 people who smoked daily and wanted to quit to receive either a nicotine-containing e-cigarette and placebo tablets, varenicline and an e-cigarette without nicotine, or a placebo tablet and a nicotine-free e-cigarette for 12 weeks. All three groups were also given intensive tobacco cessation counseling.
    • “After 26 weeks, roughly equal percentages of participants using varenicline and e-cigarettes — 43.8 percent and 40.4 percent, respectively — had stopped smoking. The difference in quit rates between the two groups was not statistically significant.
    • “The JAMA study is the first published randomized controlled trial to compare varenicline, also known as Chantix, directly to e-cigarettes. Several studies have demonstrated that e-cigarettes can help adults quit smoking. However, most studies have compared e-cigarettes to placebo alone, or to nicotine replacement therapy, such as patches and lozenges, which help smokers manage their withdrawal symptoms.
    • “The trial is likely to cause a stir within the tobacco-control community, which has been bitterly divided over the question of whether e-cigarettes are a help or hindrance for adults who smoke cigarettes, and whether they should be recommended by doctors as a way to kick a smoking habit. While countries like the United Kingdom actively encourage smokers to use these products to help them quit cigarettes, nations including the United States and Japan have been far more conservative. Backers of e-cigarettes say this study shows the U.K. has the right idea.”

From the U.S. healthcare business front,

  • In Medicare Advantage STAR ratings news, Modern Healthcare tells us,
    • “Nonprofit health insurance companies historically have outperformed for-profit competitors on star ratings and could be disadvantaged when their rivals are boosted, but the Alliance of Community Health Plans doesn’t see a concern.
    • “It is equitable that plans that are going to have their scores recalculated for ’24 and have a change in their revenue have a chance to modify their ’25 bids because they were at a different place when they submitted it,” said Michael Bagel, associate vice president of public policy at the trade group for nonprofit insurers.
    • “Allowing only insurers that get increased scores to resubmit bids could provoke lawsuits, Meekins said. “There’s still the potential for legal challenges to that because there’s a bit of game theory that goes into the bid process and what you think other people are going to do,” he said.
    • “CMS has not said how it will handle star ratings for 2025, whether it will reinstitute the methods the courts overturned on technical grounds or whether it will appeal the Elevance Health and SCAN Health Plan decisions.”
  • Beckers Hospital Review identifies “37 health systems with strong operational metrics and solid financial positions, according to reports from credit rating agencies Fitch Ratings and Moody’s Investors Service released in 2024.”
  • Fierce Healthcare offers a special report naming “the top 10 nonprofit health systems by 2023 operating revenue.”
  • MedCity News relates
    • “Retailers are facing several headwinds in healthcare in 2024. Walmart and Dollar General both recently ended healthcare endeavors, and CVS Health is reportedly looking for a private equity partner for Oak Street Health (which it acquired in 2023). VillageMD, which is backed by Walgreens, is shuttering numerous clinics.
    • “Still, Mary Langowski, executive vice president and president of U.S. healthcare at Walgreens Boots Alliance, sees a strong future for retailers in healthcare.
    • “I happen to be very bullish on the role of retail in healthcare and frankly, having a very central role in healthcare,” she said. “And part of that is because over 80% of people want health and wellness offerings in a pharmacy and in a retail setting. Consumers want the ease, they want the convenience of it. And those are important things to keep in mind, that demand is there.”
    • “Langowski, who joined Walgreens in March, made these comments during a Tuesday fireside chat at the AHIP 2024 conference held in Las Vegas. She added that what the industry is seeing is not an “evolution” of whether retailers will exist in healthcare, but a shift around what the “right model is going to be.” 
  • The Washington Post notes,
    • “If your doctor can’t see you now, maybe the nurse practitioner can.
    • “Nurse practitioners have long been a reliable backstop for the primary-care-physician shortfall, which is estimated at nearly 21,000 doctors this year and projected to get worse.
    • “But easy access to NPs could be tested in coming years. Even though nearly 90 percent of nurse practitioners are certified to work in primary care, only about a third choose the field, according to a recent study.
    • “Health-care workforce experts worry that NPs are being lured toward work in specialty practices for the same reason that some doctors steer clear of primary care: money.”


Thursday Miscellany

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington DC,

  • Federal News Network lets us know,
    • “For federal employees, a bill pending in the Senate would bring expanded coverage of fertility treatments through the Federal Employees Health Benefits (FEHB) program.
    • “But the Right to IVF Act, which Sens. Tammy Duckworth (D-Ill.), Patty Murray (D-Wash.) and Cory Booker (D-N.J.) introduced last week, did not garner the 60 votes needed to move forward with a floor vote Thursday afternoon. Almost all Republicans voted against the measure to advance the legislation, resulting in a 48-47 tally.
    • “The legislation rolls together three previous bills all aiming to improve access and insurance coverage for in-vitro fertilization (IVF). In part, the bill would have impacts specifically on FEHB enrollees. One component of the Right to IVF Act aims to set higher requirements for FEHB carriers to offer IVF coverage.
    • “The Office of Personnel Management increased FEHB carrier requirements for IVF treatments for plan year 2024. But the legislation looks to further extend the requirements of IVF to cover both treatments and medications, as well as expanding to more types of assisted reproductive technology (ART).”
  • Many large FEHB plans cover ART procedures. Competition will cause other plans to follow their lead.
  • Federal News Network also identifies House of Representatives policy riders to FY 2025 appropriations bills that are relevant to federal employees and their benefit programs.
  • The American Hospital Association News relates,
    • “The House Energy and Commerce Health Subcommittee June 13 held a hearing about transitioning to value-based care. The AHA submitted a statement to the subcommittee for the hearing, expressing support for value-based care and sharing principles the Center for Medicare and Medicaid Innovation should consider when designing alternative payment models. Those principles include adequate on-ramp and glidepath to transition to risk; adequate risk adjustment; voluntary participation and flexible design; balanced risk versus reward; guardrails to ensure participants don’t compete against themselves when they achieve optimal cost savings and outcomes; and upfront investment incentives.” 
  • Healthcare Dive informs us,
    • “The Supreme Court on Thursday unanimously ruled an anti-abortion group contesting the Food and Drug Administration’s approval of the abortion pill mifepristone does not have a legal basis to sue, putting an end to a drawn-out and high-profile court battle.
    • “The court held the plaintiffs’ “desire to make a drug less available to others” did not give them standing to challenge the FDA’s actions around mifepristone.
    • “The plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact,” Justice Brett Kavanaugh wrote in the court’s opinion. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
  • The Wall Street Journal adds,
    • “An appeals panel [in August 2023] rolled back much of the [district court’s] ruling, saying it was too late to challenge the drug’s original approval. But the appeals court did find that the plaintiffs had standing to sue, and it ruled the FDA’s efforts beginning in 2016 to make the pill more available were unlawful. The Supreme Court had previously put that ruling on hold, preserving the status quo of widespread mifepristone access while it considered the case. * * *
    • “The pill case won’t be the last time the justices weigh in on abortion access this term. The court in the next couple of weeks is expected to decide a separate case out of Idaho that centers around the question of whether a federal law that requires hospitals to provide stabilizing care for patients at risk of death or serious injury trumps state abortion bans that allow doctors to perform the procedure only if a woman’s life is in jeopardy.”
  • STAT News notes,
    • “Both President Biden and former President Trump love to claim credit for getting more Americans $35 insulin.
    • “But the credit should actually go to a giant pharmaceutical company — just the type that both men claim to have challenged.
    • “Eli Lilly, an $800 billion pharma giant and one of three insulin manufacturers in the United States, first proposed an experiment allowing Medicare insurance plans to offer $35 monthly insulin in 2019, CEO David Ricks and former Medicare agency chief Seema Verma said in interviews with STAT.
    • “It is true. We approached CMS with that idea,” Ricks said, referring to the government Medicare agency.
    • “Verma gave Ricks credit. “He is an unsung hero. He was actually the mastermind of all of this,” she said.”
  • Per Department of Health and Human Services press releases,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded more than $11 million to 15 organizations to establish new residency programs in rural communities. HHS Secretary Xavier Becerra and White House Domestic Policy Advisor Neera Tanden announced the new awards while visiting rural health clinic in Wisconsin Rapids, Wisconsin today. Building on HRSA’s Enhancing Maternal Health Initiative, one program will create the first obstetrics and gynecology Rural Track Program in the country, and six others will develop new family medicine residency programs with enhanced obstetrical training in rural communities.”
    • “For more information about the Rural Residency Planning and Development Program, visit https://www.hrsa.gov/rural-health/grants/rural-health-research-policy/rrpd.”
  • and
    • “The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is announcing up to $500 million in Project NextGen funding to plan and execute multiple Phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.
    • “We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” said HHS Secretary Xavier Becerra. “We are making progress on the development of cutting-edge treatments, such as vaccines administered as a nasal spray or as a pill. The Biden-Harris Administration won’t stop until we have the next generation of innovative vaccines, therapeutics, and other tools to protect against COVID-19, or any other pathogen that could threaten the American public.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Avoid raw milk. Lay off cheeses made with unpasteurized milk. And cook your beef to medium- or well-done temperatures.
    • “These are the precautions that public health officials and doctors recommend as they track the H5N1 bird flu outbreak in U.S. cattle. Ten states have H5N1 outbreaks in cows, according to the Centers for Disease Control and Prevention, and at least three U.S. dairy farmworkers have been diagnosed with bird flu. 
    • “A man in Mexico contracted a different strain of bird flu—H5N2—earlier this month and died, though he died from underlying conditions, according to the Mexican government.
    • “Doctors and federal officials say the public health risk of getting H5N1 is currently very low unless you work on a farm, and stress that there has been no evidence of human-to-human transmission. What’s raised concern is that the most recent case—found in a dairy worker in Michigan earlier this month—had respiratory symptoms unlike the previous two cases where the primary symptom was pinkeye. 
    • “Viruses with respiratory symptoms are more contagious and transmissible than conjunctivitis, or pinkeye, so doctors and scientists say they are watching closely. For now, it has been more than a week since the worker tested positive and there have been no known cases of transmission.”  
  • The NIH director in her weekly blog tells us,
    • We know stress can take a toll on our mental health. Yet, it’s unclear why some people develop stress-related mental health disorders and others don’t. The risk for developing a stress-related mental health disorder such as post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) depends on a complex interplay between the genetic vulnerabilities we are born with and the impact of traumatic stress we experience over our lifetimes.
    • Given this complexity, it’s been difficult for researchers to pinpoint the underlying biological pathways in the body that ultimately produce changes associated with PTSD, major depression, or other mental health conditions. Now, a study reported in a special issue of Science on decoding the brain uses a comprehensive approach to examine multiple biological processes across brain regions, cell types, and blood to elucidate this complexity. It’s an unprecedented effort to understand in a more holistic way the essential biological networks involved in PTSD and MDD. * * *
    • “There’s clearly much more to discover in the years ahead. But these insights already point to important roles for known stress-related pathways in fundamental brain changes underlying PTSD and MDD, while also revealing more novel pathways as potentially promising new treatment targets. With further study, the researchers hope these findings can also begin to answer vexing questions, such as why some people develop PTSD or major depression after stressful events and others don’t.”
  • STAT News points out that “With placenta-on-a-chip, researchers hope to gauge how drugs and toxins impact pregnancy.”
    • “[Mechanical engineer Nicole] Hashemi and her colleagues received a three-year, $350,000 grant from the National Science Foundation to advance their current placenta-on-a-chip model. They plan on designing systems that can be integrated into the model to help collect data in real time. Hashemi told STAT that one system could look at changes in the shapes of cells when exposed to chemicals or physical stressors.
    • “The placenta-on-a-chip technology is simple but potentially powerful, and similar efforts are being made to replicate the environments of other human organs. The small chip is usually about the size of a rubber eraser, etched with tiny channels through which fluids move — offering a simplified, functional model of an organ to test drugs or to study the progression of disease. Researchers can grow cells and run fluids that act like blood through chambers in the chip to create environments similar to those in the human body.
    • “According to Dan Huh, a professor of bioengineering at the University of Pennsylvania and a leader in developing many organs-on-a-chip including the placenta and lung, maintaining the environment is almost like tricking the cells into thinking that they’re still in the body so that they “do what they’re supposed to do.”
  • MedPage Today tells us,
    • “Disrupted access to prescription stimulants for patients with attention deficit-hyperactivity disorder (ADHD) may increase risks of injury or overdose, the CDC warned on Thursday following the indictment of an online ADHD medication prescriber over fraud allegations.
    • “Several ADHD stimulants such as immediate-release amphetamine (Adderall) are already in shortage, and the new federal healthcare fraud indictment may further disrupt care for as many as 50,000 patients with ADHD, the CDC detailed.
  • The Journal of the American Medical Association released a research letter about trends in Naloxone dispensing from U.S. retail pharmacies.
    • “Naloxone prescriptions dispensed from retail pharmacies increased from 2019 to 2023, with the largest single-year increase observed in 2022. This increase may reflect efforts to expand naloxone prescribing, including state-level standing orders3 and clinical practice guidelines. Although statistically significant increases were observed among most prescriber specialties between 2019 and 2023, nearly two-thirds of dispensed naloxone was prescribed by advanced practitioners and primary care specialties in 2023. Continued efforts such as evidence-based academic detailing and electronic health record alerts can support clinicians in prescribing naloxone.
    • “The observed decrease in retail pharmacy–dispensed naloxone prescriptions during Q3 and Q4 2023 may be due to naloxone becoming available over the counter,4 though trend analysis indicated the decline was not statistically significant. Studies have found that over-the-counter naloxone has a higher out-of-pocket cost than insurance-paid naloxone prescriptions,5 indicating the continued importance of prescribed naloxone and naloxone accessed in community-based settings. * * *
    • “Although naloxone dispensing has increased in recent years, opportunities remain to expand access given the continued high burden of opioid overdoses,1 such as by increasing co-prescribing of naloxone for patients with high-risk opioid prescriptions2,6 and reducing financial barriers.5“

From the U.S. healthcare business front,

  • The Wall Street Journal reports good news for Medicare Advantage insurers,
    • “The federal government plans to redo this year’s quality ratings of private Medicare plans, according to people familiar with the matter, a move that would deliver hundreds of millions in additional bonus payments to insurers next year.
    • “The decision by the Centers for Medicare and Medicaid Services could be announced as soon as Thursday. It comes in the wake of two court rulings that faulted the agency’s ratings, in cases filed by insurers SCAN Health Plan and Elevance Health.
    • “By paving the way for higher payments, the CMS move would provide a win for Medicare insurers at a time when their business is under pressure from rising healthcare costs and rates for next year that came in lower than investors had expected.'”
  • Mercer Consulting explores “Unlocking the power of [healthcare] price transparency data.”
  • MedTech Dive informs us,
    • “Philips has launched its Duo Venous Stent System in the U.S. to treat patients with blockages in their veins, the company said Wednesday.
    • “The implant, which won approval in December, is designed to address the root cause of chronic deep venous disease and comes in two forms for use in different types of veins. 
    • “Philips acquired the device in its 2022 takeover of Vesper Medical. The company paid 227 million euros upfront for Vesper to expand its image guided therapy business.”
  • and
    • “Medline has asked hospitals to remove thousands of endotracheal tubes because of a risk that components can tear or detach, blocking a patient’s airway. 
    • “The company recalled more than 168,000 Medline Sub-G Endotracheal Tubes and more than 13,000 kits, according to a Food and Drug Administration notice posted on May 28. The tubes are used for mechanical ventilation and have ports to prevent fluid from draining into patients’ lungs and causing pneumonia. 
    • “Medline recalled the products because the inflation tube and other components can detach or tear from the main tube, causing it to leak or deflate. If the device comes apart during use, it could also obstruct the patient’s airway or cause choking, the FDA said in a Tuesday notice.
  • and
    • “Abbott is recalling a system monitor used with the Heartmate cardiac pump because screen display issues could pose a risk to patients. The Class 1 recall affects 4,842 monitors distributed in the U.S. and worldwide, according to a June 7 database entry by the Food and Drug Administration.
    • “In an urgent medical device correction letter to physicians in May, Abbott said no serious adverse health consequences were reported and no devices are being removed from the market.
    • “The latest recall follows three others from earlier this year involving the Heartmate left ventricular assist system, the only such mechanical circulatory support device on the U.S. market after Medtronic stopped selling its Heartware pump in 2021.”

Monday Roundup

David Ermer–FDA, Medical / Rx research, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “Big tobacco companies and their critics agree on at least one thing: The illegal, fruit-flavored, disposable vapes that are popular among teenagers have flooded the U.S. market and federal regulators haven’t done enough to stop it.
    • “The Food and Drug Administration and Justice Department said Monday they are stepping up enforcement by forming a multiagency task force to go after the illegal distribution and sale of e-cigarettes.
    • “Disposable vaping devices, almost none of which are authorized for sale by the FDA, represent more than 30% of U.S. e-cigarette sales in stores tracked by Nielsen, according to an analysis by Goldman Sachs. Many of them are imported from China. Breeze Pro and Elfbar, both of which were ordered off the market last year by the FDA, remain the top two disposable e-cigarette brands in the U.S.”
  • Per BioPharma Dive,
    • “An experimental and closely watched medicine for Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration. “An experimental and closely watched medicine for Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration.
    • “On Monday, the panel unanimously voted that the medicine, developed by Eli Lilly and known as donanemab, appears to be an effective treatment for certain Alzheimer’s patients. The experts also concluded, by an 11-0 vote, that the drug’s benefits outweigh its risks, despite some safety concerns.
    • “I thought the evidence is very strong and the trials [show] the effectiveness of the drug,” said Dean Follman, a panelist and assistant director of biostatistics at the National Institute of Allergy and Infectious Diseases.”
  • Federal News Network tells us,
    • “Postmaster General Louis DeJoy is billing the Postal Service’s survival from the worst days of the COVID-19 pandemic as an unsung comeback story — but the agency is still writing its next chapter, as it figures out how to stay financially healthy in the long term.
    • “DeJoy, speaking Monday at the National Postal Forum in Indianapolis, said he inherited a “broken business model” when he took office in June 2020 — and that the agency was months away from running out of cash at the height of the COVID-19 pandemic.
    • “Failure to adequately adapt to social, economic, technological, and industrial changes have destroyed giants in their industry – Kodak, Motorola, Blockbuster – in just a few short years,” DeJoy said in his keynote address. “The demands of the changes experienced by the Postal Service were magnitudes greater. In addition, these organizations did not have a Congress or a regulator to contend with.”
    • “Four years into his tenure as postmaster general, DeJoy is defending USPS changes under this 10-year reform plan — some elements of which USPS is temporarily pausing, after bipartisan scrutiny from Congress.”

From the public health and medical research front,

  • BioPharma Dive lets us know,
    • “Moderna on Monday said a combination flu and COVID-19 shot it’s developing met the goal of a late-stage study, eliciting higher immune responses to the two viruses than did available vaccines when tested among adults 50 years or older.
    • “Dubbed mRNA-1083, the shot is made up of Moderna’s second-generation COVID vaccine and a candidate for influenza, which have each been tested on their own in separate trials. The company pit mRNA-1803 against Spikevax, its approved COVID vaccine, and against flu shots from drugmakers Sanofi and GSK.
    • “Moderna said the data showed a single dose of mRNA-1083 was statistically equivalent, or “non-inferior,” to giving those vaccines together. It plans to present full results at an upcoming medical meeting, and to discuss next steps with regulators.”
  • STAT News reports,
    • “It’s a familiar scene for patients during a routine primary care visit. The doctor scans blood test results, notes high cholesterol flagged by a standard calculator to assess risk of heart attack or stroke, then decides — and ideally discusses — whether to recommend taking a statin to cut the risk over time.
    • “That conversation may happen less often if changes in the risk model presented by the American Heart Association in November translate into new guidelines for prescribing statins. Those guidelines haven’t been recalibrated yet, but a new analysis suggests that the new risk model could mean far fewer Americans — as many as 40% less than current calculators say — would be candidates for cholesterol-lowering drugs to prevent cardiovascular disease.”
  • NBC News informs us,
    • “New research points to a better way to measure obesity than body mass index.” New research points to a better way to measure obesity than body mass index.
    • “Body mass index was first developed in 1832 and has been the standard way to estimate a person’s body fat since the 1980s. The calculation, however, has come under increasing scrutiny in recent years.
    • “One major critique of BMI is that it doesn’t look at how much of a person’s weight is fat, and where fat is distributed around the body. It also doesn’t take into account the other elements that make up a person’s body composition beyond fat, including muscle, bone, water and organs.
    • “Fat distribution and body composition can vary dramatically among different people with the same BMI,” Wenquan Niu, a professor at the Capital Institute of Pediatrics in Beijing, wrote in an email.
    • “Because muscle is much denser than fat, BMI skews higher in people who are very muscular but have less body fat, like athletes, Niu said. On the other end of the spectrum, BMI can be underestimated in older people with much less muscle mass and more body fat.
    • ‘In a study published last week in JAMA Network Open, Niu and his colleagues showed that a different measurement, called the body roundness index, is a more precise way to estimate obesity.”
    • While BMI estimates a person’s body fat using just two measurements, height and weight, BRI also incorporates hip and waist circumferences to estimate how much total fat and visceral fat someone has. Visceral fat is a type of deep belly fat that surrounds the organs and can be more harmful to health.
  • Medscape offers an update on new oral weight loss drugs and tells us,
    • Fewer than one in five people eligible for lung cancer screening reported being up to date with screening in 2022, though patient navigation added to usual care could be a way of increasing these rates, according to two studies published in JAMA Internal Medicine.
    • Among nearly 26,000 respondents in a nationwide cross-sectional study, the overall prevalence of up-to-date lung cancer screening was 18.1% but varied across states (range 9.7% to 31%), with relatively lower rates in Southern states that have a high lung cancer mortality burden, noted Priti Bandi, PhD, of the American Cancer Society, and colleagues.

From the U.S. healthcare business front,

  • The Altarum Institutes posted a report titled “Utilization and Price Drivers of Increasing Health Care Spending (2010-2023).”
    • “Following the 2022 slowdown in health care spending that led to the overall health care sector reaching its smallest share of the economy since 2014 (17.3%), there has been a gradual resurgence in health care spending beginning in early 2023. This resurgence, driven predominantly by the greater use of care (and particularly a return of elective and outpatient services), is following the pandemic-affected period of very slow spending growth, postponed care, and health care labor shortages from 2020 through 2022. Higher utilization has been observed in data such as our monthly Altarum health care spending and prices briefs, as well as other industry sources such as hospital and insurer financial reports. In this blog, we put 2023’s above-average health care utilization increases into perspective historically and break down utilization trends by the different major health care spending categories.
    • “Following the 2022 slowdown in health care spending that led to the overall health care sector reaching its smallest share of the economy since 2014 (17.3%), there has been a gradual resurgence in health care spending beginning in early 2023. This resurgence, driven predominantly by the greater use of care (and particularly a return of elective and outpatient services), is following the pandemic-affected period of very slow spending growth, postponed care, and health care labor shortages from 2020 through 2022. Higher utilization has been observed in data such as our monthly Altarum health care spending and prices briefs, as well as other industry sources such as hospital and insurer financial reports. In this blog, we put 2023’s above-average health care utilization increases into perspective historically and break down utilization trends by the different major health care spending categories.
    • Over the past fifteen years, rising U.S. health care spending has been driven both by increased utilization and higher prices, with utilization increases contributing more to higher spending (Figure 1). Since 2010, utilization of personal health care (spending on health goods and services, excluding spending on program administration, net cost of insurance, public health activities, and investment) has increased 47% (contributing about 60% of the overall spending growth), while underlying prices for care have increased 31%. Greater utilization since 2010 has been affected by increases in overall population rates of health insurance coverage, an aging population, greater direct government support for health care during the pandemic and increases in the intensity of care provided for many health care needs.” 
  • Per MedTech Dive,
    • “Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration.” Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration.
    • “One product is the company’s Lingo device, sold as a wellness product for people who do not have diabetes. The other is Abbott’s new Libre Rio device, which is intended for adults with Type 2 diabetes who do not use insulin, posing a direct challenge to Dexcom’s Stelo device. 
    • “After Lingo was cleared last week, RBC Capital Markets analyst Shagun Singh wrote the over-the-counter nod could offer a more than $1 billion sales opportunity for Abbott.”
  • Per Fierce Healthcare,
    • “Bobby Mukkamala, M.D., was voted in as president-elect of the American Medical Association (AMA) at the group’s annual meeting in Chicago. He will take over for immediate past president Jesse Ehrenfeld, M.D., whose last day in office is Tuesday, June 11. “Bobby Mukkamala, M.D., was voted in as president-elect of the American Medical Association (AMA) at the group’s annual meeting in Chicago. He will take over for immediate past president Jesse Ehrenfeld, M.D., whose last day in office is Tuesday, June 11. 
    • “Mukkamala will serve a one-year term for the physician advocacy group, which has been focused on reforming Medicare physician pay, reducing prior authorization burden and mitigating provider burnout, including through the use of technology to augment provider workflow. 
    • “Mukkamala is an otolaryngologist from Flint, Michigan, who has served in leadership roles within the American Medical Association and for local health initiatives in Michigan. He chairs the Substance Use and Pain Care Taskforce of the AMA and served on its board of trustees in 2017 and 2021.”
  • and
    • “Thought leaders from across the insurance industry will descend on Las Vegas this week for AHIP’s annual conference, kicking off three days of discussions on the biggest issues facing payers.”
    • “The Fierce Health Payer team will also be making the journey to Sin City, so keep an eye out for our coverage over the next several days. Ahead of the event, here’s a look at three key trends we expect to hear plenty about across panels, keynotes and meetings.”
      • GLP-1 Drug Costs and Shortages Remain Center-Stage
      • Continued Talk about Implementation of Value-Based Care, and
      • Cutting through the AI Hype.
  • Healthcare Dive adds,
    • “Teladoc Health has named a new CEO, months after the virtual care company’s long-term chief executive abruptly departed following flagging financial performance at the telehealth vendor.
    • “Charles “Chuck” Divita III will take on the role effective immediately, the company said Monday.
    • “His appointment comes about two months after Jason Gorevic, the former CEO who held the position since 2009, left the company.
    • “We are confident we have selected an innovative and visionary leader capable of delivering growth at scale, value for our clients and positive relationships with all our partners and colleagues,” David Snow Jr., chairman of Teladoc’s board of directors, said in a statement.
    • “Divita joins the virtual care company from GuideWell, a healthcare insurance and services company that includes Florida Blue, where he served as executive vice president of commercial markets and previously chief financial officer. He also worked as CFO at FPIC Insurance Group, which focuses on medical professional liability.”

Friday Factoids

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplas

From Washington, DC,

  • The Washington Post reports
    • Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) this week wrote to eight pharmaceutical company CEOs, urging them to remove 130 patents from a key federal registry, according to letters shared with The Washington Post. The Democrats are targeting Novo Nordisk, including some of its patents related to expensive drug Ozempic; GlaxoSmithKline; and other companies that produce asthma and diabetes medications.
    • The 130 patents are among more than 300 patents that the Federal Trade Commission in April identified as “junk patent listings” that should be removed from the registry and are blocking competitors from producing cheaper alternatives. Monday is the deadline for the companies to remove the patents or reaffirm that they believe the patents are legal, according to a person who spoke on the condition of anonymity to detail the private enforcement process.
  • STAT News tells us,
    • “The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50.”The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50.
    • “Arexvy, which was the first RSV vaccine approved, now becomes the first to be available to adults under the age of 60 who are not pregnant. Prior to this FDA decision, Arexvy was licensed for use in people 60 and older.”
  • Tammy Flanagan writing in Govexec discusses the state of federal civil service retirement: CSRS and FERS.
  • Govexec adds,
    • “The government’s backlog of pending retirement claims from federal workers hit an eight-year low last month. “The government’s backlog of pending retirement claims from federal workers hit an eight-year low last month.
    • “The Office of Personnel Management’s retirement process and subsequent backlog has long dogged the federal government’s HR agency, frustrating agencies and departing federal employees alike, in large part due to paper-based legacy personnel systems.
    • “But last year, OPM instituted a number of measures to try to make immediate improvements to the process, including dedicating more resources and manpower during the early-year busy season for retirement claims and setting up a new dashboard for claimants to better understand the process and avoid common pitfalls.
    • “In May, OPM received 6,751 new retirement applications, a slight decrease from the 6,901 it received the previous month. But after a modest decrease in the number of claims actually processed in April, the agency increased its pace again last month, processing 8,793 claims.
    • “By the end of the month, the backlog had fallen to 14,035, compared to 16,077 pending claims at the end of April. That marks the smallest retirement backlog OPM has experienced since May 2016, when it also finished the month with a backlog of 14,035 applications.”

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • Summary
      • Seasonal influenza, COVID-19, and RSV activity is low nationally.
    • COVID-19
      • Most key indicators are showing low levels of activity nationally. However, COVID-19 test positivity has increased to 4.5%. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 30 states and territories, declining or likely declining in 1 state or territory, and are stable or uncertain in 18 states and territories, based on Rt estimates of epidemic growth. An increasing proportion of the variants that cause COVID-19 are projected to be KP.3 and LB.1 (CDC COVID Data Tracker: Variant Proportions).
    • Influenza
    • RSV
      • Nationally, RSV test positivity remains low. Hospitalization rates are low in all age groups.
    • Vaccination
  • The Washington Post offers background on bird flu — How it spreads, milk and egg safety and more.
  • The New York Times reports,
    • “The American Cancer Society has begun an ambitious, far-reaching study focusing on a population that has long been overlooked, despite high rates of cancer and cancer-related deaths: Black women.”The American Cancer Society has begun an ambitious, far-reaching study focusing on a population that has long been overlooked, despite high rates of cancer and cancer-related deaths: Black women.
    • “The initiative, called VOICES of Black Women, is believed to be the first long-term population study of its size to zero in specifically on the factors driving cancer prevalence and deaths among Black women.
    • “Researchers plan to enroll 100,000 Black women without cancer, ages 25 to 55, in Washington, D.C., and 20 states where most Black American women reside. The subjects will be surveyed twice a year about their behaviors, environmental exposures and life experiences, and followed for 30 years; any cancers they may develop will be tracked.
    • “Similar studies by the American Cancer Society in the past yielded critical lessons about what causes cancer — for example, identifying cigarette smoking as a cause of lung cancer and linking red- and processed-meat consumption to increased risk of colon cancer.”
  • STAT News points out,
    • “The moment when a person stops taking their antidepressant is fraught. Not only can patients see their psychiatric symptoms return, but they can experience a wide variety of new symptoms in the days and weeks immediately following the medication change.
    • “Symptoms like nausea and headache can be manageable, and typically begin and end within days of ending the medication. But more disruptive effects like insomnia, irritability, and sensory disturbance, or even severe ones like suicidal ideation or lethargy, can lead patients to reconsider their decision to stop treatment, even when they resolve relatively rapidly.
    • “A new systematic review of studies on antidepressant discontinuation published on Tuesday in The Lancet Psychiatry provides insight into the frequency and gravity of those symptoms. The review, which included 79 studies capturing 21,000 patients, found that about 15% experienced withdrawal symptoms after weaning from antidepressants. In 2 to 3% of the cases, the symptoms were severe.
    • “The analysis “is an important and long overdue contribution to the research literature,” said Awais Aftab, a professor of psychiatry at Case Western Reserve University School of Medicine, who did not participate in the study. It confirms that withdrawal symptoms do happen with clinically relevant frequency, and should be managed with care. But it demonstrated a lower incidence than recent estimates based on online surveys, which generated public alarm when they suggested symptoms may occur in half or more of the patients.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Humana and CVS, two of the largest Medicare Advantage insurers in the country, are poised to seriously downgrade their plan benefits and geographic presence next year as they chase profits in the privately run Medicare program.”Humana and CVS, two of the largest Medicare Advantage insurers in the country, are poised to seriously downgrade their plan benefits and geographic presence next year as they chase profits in the privately run Medicare program.
    • “As a result, hundreds of thousands of Medicare Advantage seniors — and the billions in revenue they represent — could come up for grabs, representing a significant opportunity for insurers looking to take on more members despite ongoing challenges in MA.
    • “The size of the turnover depends on a number of factors. Deciding which benefits to cut versus keep is a tough calculus, and there are guardrails from the federal government limiting cutbacks, experts say.
    • “Those decisions have been made — bids were due to the CMS on Monday. However, it will be months before the industry knows how much turbulence Humana and CVS might cause in their drive to bolster profits next year, and which insurers might benefit.
    • “Of the national payers, market leader UnitedHealth may be best situated to pick up switching seniors, solidifying its dominance in MA, experts say.
    • “I think there will be a huge shakeup,” Alexis Levy, the managing director of health consultancy Chartis’ payer advisory practice, said.”
  • Beckers Payer Issues notes,
    • “Artificial intelligence has the potential to lower internal and member costs, for insurers while also increasing profits, but the industry has largely not embraced these opportunities, according to a June 5 analysis from McKinsey.”Artificial intelligence has the potential to lower internal and member costs, for insurers while also increasing profits, but the industry has largely not embraced these opportunities, according to a June 5 analysis from McKinsey.
    • “Incremental approaches will continue to yield only minor savings, as we have seen to date across most of the industry,” the analysts wrote. “To capture full value, payers must reimagine the end-to-end processes of each domain.”
    • “Three key takeaways: 
      • 1. “If payers fully implemented already available generative AI and automation technologies, on average they could save 13-25% on administrative costs, 5-11% on medical costs and increase revenues by 3-12%.
      • 2. “Marketing and sales, utilization management, and IT are the divisions with the largest potential opportunities when using AI.
      • 3. “Payers that want to better use AI technology should have these six key things: a strategic plan, the right talent, a conducive operating model, technological capabilities, consumable data and the ability to ensure adoption and scale.
      • “In general, most payers are ill-equipped to pursue this opportunity,” the analysts wrote. “To do so, they have to close the gap that exists between their current capabilities and those needed to fully address the six areas outlined above.”
  • STAT News relates,
    • “Amid rising concern over prescription drug shortages, a new report finds that the number of shortages has increased over the past decade, most are lasting longer than ever before, and the problem is affecting medicines used to treat a wide range of maladies.
    • “Specifically, the average shortage lasted for more than three years in 2023 compared to about two years in 2020, and 27 of the 125 drugs in short supply were not available for more than five years. And 53% of new shortages occurred among generic sterile injectable medicines, according to the report from U.S. Pharmacopeia, an independent organization that develops standards for medicines.
    • “Meanwhile, most medicines for which shortages existed cost less than $5; nearly one-third of injectables cost less than $2; and two-thirds of solid oral medicines cost $3 or less. These low prices also translated into more product discontinuations, which rose by 40% from 2022 to 2023, and from 100 drugs to 140 during that time. This was also the highest rate of product discontinuations since 2019.
    • “A key culprit, according to U.S. Pharmacopeia, often are thin profit margins. “Economic pressures, especially the very low prices that generics manufacturers recover for many medicines, along with contracts that are frequently broken, have left our generic medicine supply chain fragile,” said Anthony Lakavage, senior vice president for global external affairs, in a statement.”

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Medical / Rx research, Mental health care, NIH, Obesity, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • OPM’s proposed supplemental Postal Service Health Benefits Program rule was posted on the Federal Register’s public inspection list today. The proposed rule will be published in the Federal Register tomorrow and the comment deadline will be thirty days thereafter.
  • The American Hospital News informs us,
    • “The Senate Committee on Health, Education, Labor and Pensions May 23 passed legislation that included proposals on mental health and emergency pediatric services during a markup session. The AHA submitted a statement for the hearing, expressing support for the passage of the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act (S. 3679), which would reauthorize grants for health care providers to establish programs offering behavioral health services for front-line workers, as well as a national education and awareness campaign providing health leaders with evidence-based solutions to reduce health care worker burnout. The AHA also expressed support for the bill as a member of the Healthcare Workforce Coalition, which earlier this week sent a letter to Senate HELP Committee leadership.” 
  • and
    • “The AHA praised Congress May 23 for their support and introduction of the bipartisan Hospital Inpatient Services Modernization Act, which would grant a five-year extension to the hospital-at-home program. 
    • “Standing up a H@H program requires logistical and technical work, with an investment of time, staff and money,” AHA wrote in letters to Senate and House leaders. “In addition to being approved for the federal waiver, some providers must navigate additional regulatory requirements at the state level. For some, this whole process could take a year or more to complete before that first patient is seen at home. A longer extension of the H@H program would provide much-needed stability for existing programs to continue providing care to their patients, and it would give time for others to start programs allowing more patients to benefit from this innovative program.” 
  • and
    • “The AHA May 23 submitted statements for a House Ways and Means Subcommittee on Health hearing on challenges for private physician practices, and a House Budget Committee hearing on the budgetary effects of consolidation in health care. For the Ways and Means Committee hearing, AHA noted how physicians are challenged by increased costs, inadequate reimbursements and administrative burdens from public and private insurer practices.”  
  • Healthcare Dive lets us know,
    • “Drugmakers are allowed to limit and impose conditions on pharmaciesthey send discounted drugs to under the 340B program, [the U.S. Court of Appeals for the D.C. Circuit] ruled Tuesday.
    • “The ruling is a win for drug manufacturers, who were previously threatened with fines from the federal government for violating guidance regarding which pharmacies they would send discounted drugs to.
    • “The Court of Appeals upholds a prior District Court ruling, which sided with drugmakers Novartis Pharmaceuticals and United Therapeutics after they sued the HHS in 2021. It’s the latest ruling regarding the controversial 340B drug program — a separate appellate court also ruled with drugmakers early last year.”
  • STAT News tells us,
    • “An independent panel of advisers to the Food and Drug Administration recommended the agency approve Guardant Health’s blood-based colon cancer detection test. If the agency follows the recommendation, it will clear an early hurdle for the test’s broader adoption.
    • “The expert panel spent hours listening to presentations from Guardant, the FDA, and members of the public before voting on the screening test, called Shield. The panel’s nine voting members then voted on whether the test was safe, effective, and whether its benefits outweigh its risks, with eight, six, and seven panelists endorsing those views, respectively.
    • “FDA approval is a requirement for winning coverage from the Centers for Medicare and Medicaid Services, which could be the difference between Guardant’s test becoming widespread — or irrelevant.” 

From the public health and medical research front,

  • MedPage Today relates,
    • “Over the last 2 years, most new cases of mpox in the U.S. occurred in unvaccinated people, and less than 1% occurred in people who were fully vaccinated against the disease, according to CDC data.
    • “Among 32,819 U.S. mpox cases reported to the CDC from May 2022 to May 2024, only 0.8% occurred among people who had received two doses of the mpox vaccine Jynneos, while 75% of cases occurred among unvaccinated people, reported Sarah Anne Guagliardo, PhD, of the CDC’s Mpox National Response Team, and colleagues in the Morbidity and Mortality Weekly Report.
    • “Despite a perceived increase in [mpox] infections among fully vaccinated persons during 2024, this report indicates that, to date, persistent vaccine-derived immunologic response among persons who received the 2-dose vaccine series exists,” the authors wrote.”
  • and
    • “An at-school vaccination program in France significantly increased human papillomavirus (HPV) vaccine coverage, according to results of the PrevHPV cluster randomized trial.
    • “Among girls and boys ages 11 to 14 years, a school-based program offering HPV vaccinations significantly increased median HPV vaccination coverage by an adjusted 5.5 percentage points after 2 months of the intervention, Morgane Michel, PhD, of the Universite Paris Cite, and colleagues reported in JAMA Network Open.
    • “The intervention consisted of three components: free at-school HPV vaccination, education and motivation of adolescents and their parents, and a training program for general practitioners (GPs). “Free HPV vaccination on school premises was the only component that consistently and significantly increased vaccination coverage,” Michel and colleagues wrote.”
  • STAT News observes,
    • “You’d think if there were a vaccine that would prevent tens of thousands of cases of cancer a year, people would want it for themselves and for their kids.
    • “But new data being released Thursday ahead of the annual meeting of the American Society of Clinical Oncology show that just isn’t the case.
    • “The data showed that the vaccine reduced the risk of HPV-related cancers by 56% in men and 36% in women — numbers that actually probably understate the efficacy of the vaccine because participants in this observational study likely got the vaccine too late to prevent all HPV infections. The data were analyzed by researchers led by Jefferson DeKloe, a research fellow at Thomas Jefferson University. * * *
    • “There is not really any debate, at this point, that this vaccine would prevent tens of thousands of cases of cancer a year if it were used more widely. It’s a miraculous product, and we should be using it.”
  • KFF reports
    • “This brief examines disparities in mental health care by race and ethnicity and other factors based on data from the 2023 KFF Racism, Discrimination and Health Survey, a large, nationally representative survey based on responses from over 6,000 adults. The survey provides unique data on access to the health care system and how factors such as racism and discrimination impact these experiences and overall health and well-being. Key findings include:
    • “Among adults who report fair or poor mental health, White adults (50%) are more likely to say they received mental health services in the past three years compared with Black (39%) and Hispanic adults (36%). Across racial and ethnic groups, about half of all adults (53%) who report that they received mental health services said they were very or extremely helpful.
    • “Adults identify cost concerns and scheduling difficulties as primary barriers to mental health care, and Hispanic, Black, and Asian adults disproportionately report additional challenges, such as finding a provider who can understand their background and experiences, lack of information, or stigma or embarrassment. Among adults who received or tried to receive mental health care, Asian (55%), and Black (46%) adults are more likely to report difficulty finding a provider who could understand their background and experiences compared to their White counterparts (38%). Among those who thought they needed mental health care but did not try to find a provider, Hispanic adults are more likely than White adults to say the main reason was they didn’t know how to find a provider (24% vs. 11%) and/or that they were afraid or embarrassed to seek care (30% vs. 18%).
    • “Adults who report unfair treatment or negative experiences with a provider are twice as likely as those without these experiences to say they went without needed mental health care. Four in ten (41%) adults who report they were treated unfairly or with disrespect by a health care provider and about one-third (35%) of adults who say they’ve had at least one negative experience with a health care provider say they did not get mental health services they thought they needed compared to smaller shares of those who do not report these experiences (18% and 15%, respectively).
    • “Reported awareness of the 9-8-8 mental health hotline remains low overall, particularly among Black, Hispanic, and Asian adults. As of Summer 2023, about one in five (18%) adults say they have heard a lot or some about 9-8-8, with Black (16%), Hispanic (11%), and Asian (13%) adults less likely to say they have heard about 9-8-8 than White adults (21%). At the same time, about one in five (21%) adults say they or a family member has ever experienced a severe mental health crisis that resulted in serious consequences such as homelessness, hospitalization, incarceration, self-harm, or suicide, with this share rising to 39% among young (ages 18-29) White adults.”
  • and
    • “Alcohol use disorder (AUD) is often an underrecognized substance use disorder (SUD) despite its substantial consequences. Over half of US adults (54%) say that someone in their family has struggled with an alcohol use disorder, making it the most prevalent non-tobacco substance use disorder. Yet, only one-third of adults view alcohol addiction as a crisis, compared to over half who see opioids as such. Federal data show that 1 in 10 people had an alcohol use disorder in the past year, over 4 in 10 alcohol users report binge drinking in the past month, and per capita alcohol consumption is higher than the decade prior. Treatment rates for alcohol use disorders are notably low, especially for the use of medication, a recommended AUD treatment component. Although the opioid crisis has been declared a public health emergency by the U.S. Department of Health and Human Services since 2017, no similar declaration exists regarding alcohol deaths. However, HHS has set a priority goal of reducing emergency department visits for acute alcohol use, mental health conditions, suicide attempts, and drug overdoses by 10% by 2025.”
  • The Washington Post adds,
    • “More people in the United States say they are using marijuana daily or near daily, compared with people who say they are drinking alcohol that often, according to a new study.
    • “In 2022, about 17.7 million people reported daily or near-daily marijuana use, compared with 14.7 million people who reported drinking at the same frequency, said the report, which was based on more than four decades of data from the National Survey on Drug Use and Health. It was the first time the survey recorded more frequent users of cannabis than alcohol, the report added.
    • “The research was published Wednesday in the peer-reviewed journal Addiction. The research window spans the years 1979 to 2022, and the 27 surveys that were analyzed involved more than 1.6 million participants during that time frame.”
  • STAT News reports,
    • “Enticed by the immense market opened by GLP-1 weight loss drugs Wegovy and Zepbound, a handful of biotech companies are trying to develop next-generation, longer-lasting therapies based on a very different approach: RNA interference.
    • “This Nobel Prize-winning science works by degrading the biological blueprints that RNA use to make proteins — without the genetic instructions, the troublesome proteins are never made and the gene is essentially muted.
    • “If the companies succeed, it would be a significant shift in the obesity treatment revolution, away from weekly drugs targeting hormones to medications that could be given much less frequently — twice a year or even less — and pinpoint genetic contributors to weight.
    • “Scientists at Regeneron and Alnylam are aiming to silence a gene expressed in the brain called GPR75, what Regeneron Chief Scientific Officer George Yancopoulos calls the “laziness gene.” Through sequencing of almost 650,000 people, they found that those with a mutation to the gene have a lower body-mass index and lower risk of obesity.
    • “Alnylam has also homed in on the INHBE gene, expressed in the liver. Scientists found that people with mutations in the gene have a lower waist-to-hip ratio — a surrogate for abdominal fat, the type of fat that’s especially harmful and is linked to cardiovascular problems. Other companies like Wave Life Sciences and Arrowhead Pharmaceuticals have caught on and are also pursuing RNAi therapies aimed at blocking INHBE.”
  • Medscape explains the scientific impact of the recent creation of a map of the human ovary.
  • BioPharma Dive takes “An early look at cancer drug study results; Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting give a peek at anticipated datasets from Immunocore, Merck & Co., J&J and Arcus.”
  • The NIH Director writes in her blog,
    • “Human consciousness requires a person to be both awake and aware. While neuroscientists have learned a great deal from research about the underlying brain networks that sustain awareness, surprisingly little has been known about the networks that keep us awake.
    • “Now, an NIH-supported team of researchers has mapped the connectivity of a neural network they suggest is essential for wakefulness, or arousal, in the human brain. According to the researchers, this advance, reported in Science Translational Medicine , is essential for understanding human consciousness. It may also lead to new ways of understanding what happens in the brain when people lose consciousness, with potentially important implications for treating those who have entered a coma or vegetative state.
    • “The team—led by Brian Edlow , Massachusetts General Hospital and Harvard Medical School, Boston, and Hannah Kinney , Boston Children’s Hospital and Harvard Medical School—set out to map the brain network that sustains wakefulness in a manner similar to earlier research that identified the default mode network, which influences awareness. Default networks in the brain are most active when people are at rest rather than focused on a goal-oriented task.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Express Scripts — one of the largest pharmacy benefit managers in the country — has notched a major partnership with independent pharmacies, amid contentious relations between the two industries.
    • “The Cigna-owned PBM unveiled a collaboration on Thursday with pharmacy network CPESN USA to coordinate care delivery for seniors on Medicare with hypertension and diabetes, two common chronic conditions. CPESN’s independent pharmacies will also help identify at-risk patients and improve medication management, according to a release.
    • “Express Scripts and CPESN plan to expand the partnership based on client feedback, said a spokesperson for Evernorth, Cigna’s health services business and the division that includes Express Scripts. Financial terms of the partnership were not disclosed.”
  • Per Fierce Healthcare,
    • “After several years of modest or declining growth, the average pay for doctors jumped 5.9% in 2023, rebounding from a decline of 2.4% in 2022.”After several years of modest or declining growth, the average pay for doctors jumped 5.9% in 2023, rebounding from a decline of 2.4% in 2022.
    • “Most medical specialties experienced positive growth in 2023, with the top 10 seeing annual growth rates exceeding 7%, according to the 2024 Physician Compensation Report from professional medical network Doximity. 
    • “Among specialties, hematology and family medicine claimed the top two spots, with double-digit percentage growth compared to 2022 (12.4% and 10.2%, respectively).” 
  • Beckers Hospital Review lists the forty highest paid physician specialties based on this report.
  • Beckers Health IT calls attention to Newsweek’s list of “the top digital health companies in the U.S. for 2024, including a breakout of 50 data analytics companies.”
  • Beckers Hospital Review identifies “10 new drug shortages, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.”

Tuesday Tidbits

David Ermer–CDC, CMS, Congress, FDA, Generative AI, Obesity, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • MedPage Today tells us,
    • Senators and experts on Tuesday examined the range of tools that brand-name drug manufacturers have used to keep generic and biosimilar competition at bay — from patent thickets and product hopping to “pay-for-delay” settlements — and wrestled with how to prevent such abuses.
    • “Too often the prices charged by Big Pharma do not reflect a scientific advancement,” argued Sen. Dick Durbin (D-Ill.), during a Tuesday hearing of the Senate Committee on the Judiciary. “Rather, they’re the result of skilled lawyers manipulating the patent system and skirting our nation’s competition laws.”
  • The Department of Health and Human Services announced,
    • “The Biden-Harris Administration is committed to lowering health care costs, promoting innovation, and making sure that taxpayer investments result in advancements in biomedical research that are accessible to everyone across the country.
    • “Today, the National Institutes of Health (NIH) issued a first of its kind draft policy proposal to promote equitable access to products stemming from NIH-owned inventions. By requiring organizations partnering with the NIH through patent license agreements to outline detailed plans for patient access to drugs, biologics, vaccines, or devices developed from NIH-owned inventions, we are accelerating how breakthroughs in medical research originating from the NIH’s Intramural Research Program can translate into affordable and sustainable solutions for patients across the country. NIH has released a request for information and welcomes public input to inform this new policy.”
  • The American Hospital News informs us,
    • “The Centers for Medicare & Medicaid Services May 21 announced that individuals now have the option to file an Emergency Medical Treatment and Labor Act complaint directly with the agency, in addition to the traditional process of contacting state survey agencies. The new form is the latest in a series of new resources from CMS to help educate the public about EMTALA.” 

From the public health and medical research front,

  • Beckers Hospital Review points out,
    • “The CDC is asking health officials in all 50 states to continue monitoring the prevalence of influenza as H5N1 bird flu infections among poultry and livestock increase and have begun to prompt concern over the possibility of human-to-human transmission, according to a news release shared with Becker’s.”The CDC is asking health officials in all 50 states to continue monitoring the prevalence of influenza as H5N1 bird flu infections among poultry and livestock increase and have begun to prompt concern over the possibility of human-to-human transmission, according to a news release shared with Becker’s.
    • “As of May 21, there has only been one confirmed human infection of the current H5N1 outbreak in a dairy farm employee in Texas, but no evidence of human-to-human transmission.”
  • KFF adds a report titled “Who is at Risk Amid the H5N1 Influenza Outbreak? Characteristics and Health Coverage of Animal Production Workers.”
  • The Blue Cross Blue Shield Association lets us know,
    • “Despite the explosion in demand for weight loss drugs known as GLP-1s, 58% of patients discontinue use before reaching a clinically meaningful health benefit. This is the key finding from new researchreleased by the Blue Cross Blue Shield Association (BCBSA) and conducted by Blue Health Intelligence® (BHI) based on data from nearly 170,000 commercial health plan members since the first FDA approval for a weight-loss GLP-1 in 2014.  
    • “When patients take medication, we want it to be safe and effective,” said Razia Hashmi MD, MPH, FAAFP, vice president of Clinical Affairs at BCBSA. “This study shows most people are unlikely to see lasting benefits.  Unfortunately, weight loss isn’t as simple as filling a prescription.”
    • “In the largest study using commercial data to date on this topic, BHI’s assessment also found that 30% of patients discontinued use of the medications within the first month. 
    • “This study underscores how much more we have to learn about these medications,” said Kim Keck, president and CEO of BCBSA. “The science behind these drugs is moving faster than our ability to truly understand which patients will benefit, how to sustain their success and how to pay for them. If we don’t get it right, we will drive up costs for everyone with little to show for it.” 
  • STAT News reports,
    • “Hundreds of genetic variants can nudge someone’s risk of breast cancer up or down or towards a particular subtype. The studies identifying those gene variants, though, have largely involved people with European ancestry and thus give a less accurate picture of breast cancer risk for people who are not white.
    • “That’s beginning to change. Last week, researchers published a genome-wide association study on breast cancer in roughly 40,000 people of African descent in Nature Genetics, marking a leap forward in scientists’ knowledge of breast cancer genetics in people of African ancestry.
    • “Before we started this study in 2016, there were just several thousand cases for Black Americans. It was a very small number,” said Wei Zheng, the study’s senior investigator and a cancer epidemiologist at Vanderbilt University. This study combined data from dozens of other studies and included genetic data for thousands of new participants, making it the largest combined breast cancer genetics study done with people with African ancestry.
    • “Specifically, the study compiled data from about 30 different studies investigating breast cancer in African or African American people. About 18,000 of them had breast cancer, while the other 22,000 were healthy controls, and investigators were able to scour their genetic data for specific variations that seemed closely related to breast cancer. The statistical power that comes with such numbers enabled the team to make two key advances.
    • “First, the team found 12 loci, or locations in the genome, that showed a significant association with breast cancer. Of those, the team identified variants of three genes that appear to increase the risk of triple negative breast cancer, one of the most aggressive subtypes. Since everyone has two copies or alleles of each gene, that means someone could have anywhere between one and six risk-related alleles of these three genes. Those who had all six risk-related alleles had roughly double the chance of getting triple negative breast cancer than those who only had three. * * *
    • “The other advance came when the researchers used the data to build a breast cancer risk prediction model for people with African ancestry. Such models take into account hundreds of different genetic variants that can slightly push breast cancer risk up, adding them all up into a polygenic risk score.”
  • The Wall Street Journal relates,
    • GSK’s experimental drug for asthma met its goals in the latest trial, moving a treatment with potential annual peak sales of more than 3 billion pounds ($3.81 billion) closer to market.
    • The British pharmaceutical company’s depemokimab drug reduced asthma attacks in late-stage trials for patients with severe eosinophilic asthma, a form of the disease caused by high levels of white blood cells, GSK said Tuesday.
    • Depemokimab could be the first approved drug to allow a long-term dosing interval, requiring only two injections a year. This would benefit patients exposed to multiple therapies, the company said.
    • GSK plans to submit the drug for approval for severe asthma in the U.S. in the second half of the year.
  • Per MedTech Dive,
    • “The Food and Drug Administration is seeking examples of artificial intelligence and machine learning models that can identify and predict freezing of gait events related to Parkinson’s disease. 
    • “Freezing of gait is a temporary loss of forward movement while walking. These episodes affect people’s quality of life and daily activities, but they can be difficult to measure because they often happen when patients are outside of a clinic or hospital setting. 
    • “By testing these models against its own data, the FDA hopes to better understand the ability of these technologies to provide digitally derived endpoints that could help with early disease detection and prevention or support treatment and care in the home.” 
  • From the U.S. healthcare business front,
  • Milliman tells us, “In 2024, the cost of healthcare for a hypothetical American family of four in a typical employer-sponsored health plan is $32,066, according to the Milliman Medical Index (MMI).”
  • The Wall Street Journal reports,
    • “National drugstore chains, once resistant to the retail apocalypse that swept across the U.S., are finally succumbing to competition from online shopping and discount stores.
    • “About 3,000 fewer drugstores were open for business at the start of this year compared with the same period in 2019, according to analytics company RetailStat, which tracks 15 pharmacy chains. 
    • “CVS Health, Walgreens and Rite Aid have each closed hundreds of stores since the onset of the pandemic. Online shopping has been growing and offers customers a more convenient way to buy household staples. 
    • “Competition has also increased from discount retailers such as Walmart, grocers such as Aldi, and dollar stores, which all sell many of the same items at lower prices. The spread of beauty stores such as Sephora further siphoned customers from drugstore aisles. 
    • “Everybody’s gone after a component of their business,” said Henry Fonvielle, president of the real-estate company Rappaport.”
  • STAT News notes that “Reports of telehealth’s death have been greatly exaggerated.”
    • “Virtual care isn’t in trouble. What is in trouble are the aftermarket telehealth solutions that largely function as a virtual extension of our siloed, fragmented health care system. This specific application of virtual care, which we call Telehealth 1.0, has consistently failed to bring meaningful value to patients, clinicians, and purchasers.
    • “In that sense, its collapse is a welcome development. It’s a sign that the market discerns where the real value lies in virtual care, and it validates the evolution from transactional, one-off care to more sophisticated virtual-first models.”
  • Per Healthcare Dive,
    • “UnitedHealth-owned Optum Rx, one of the biggest pharmacy benefit managers in the U.S., is launching a new drug pricing model next year meant to make payers’ spending on pharmaceuticals more predictable.
    • “The model, called Clear Trend Guarantee, combines costs that used to be separated out, including retail pharmacy, home delivery, specialty drug and rebates, into one single per-member price, according to a Monday release.
    • “Clear Trend is value-based, meaning Optum Rx will share in any savings tied to patient outcomes created in the model.”
  • Per Fierce Healthcare,
    • “The Purchaser Business Group on Health has unveiled a new purchasing agreement that aims to improve maternal health.”The Purchaser Business Group on Health has unveiled a new purchasing agreement that aims to improve maternal health.
    • “Benefits experts at retail giant Walmart and technology company Qualcomm led the initiative as co-chairs, with the goal of establishing “a collective commitment among employers and public purchasers of healthcare” to address maternal health and birth equity, according to an announcement from PBGH.
    • “The agreement centers on five key principles: deploying evidence-based, coordinated models to ensure high-quality care; ensuring timely access; promoting equitable care built on cultural humility; transparency and accountability; and value-based care.
    • “It also establishes a consensus for employers and public healthcare purchasers as to what high-quality and high-value maternity care is and outlines expectations for both insurers and providers to follow to meet that bar.”
  • Per BioPharma Dive,
    • “A decade ago, as British drugmaker AstraZeneca fought off a hostile takeover bid by Pfizer, CEO Pascal Soriot made a big promise: The company, he said, would boost sales by nearly three-quarters to reach $45 billion by 2023.”A decade ago, as British drugmaker AstraZeneca fought off a hostile takeover bid by Pfizer, CEO Pascal Soriot made a big promise: The company, he said, would boost sales by nearly three-quarters to reach $45 billion by 2023.
    • “With that goal now successfully met, Soriot on Tuesday announced a plan to push the company even higher, setting a target of $80 billion in annual sales by 2030. A slate of new medicines in metabolic and autoimmune disease headline the plan, which also involves sustaining existing businesses in respiratory disorders and cancer.
  • Beckers Hospital Review calls attention to “Fortune and PINC AI’s “15 Top Health Systems” list released May 21.”
  • McKinsey & Company discusses what’s new in consumer wellness trends.