Monday Roundup

CDC

Monday Roundup

David Ermer–CDC, FDA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • MedPage Today reports about FDA Commissioner Robert Califf’s speech given this past weekend.
    • “We are wowing the world in technology — much of it related to the field that you’re interested in [diabetes],” he told attendees at the keynote opening session of the American Diabetes Association Scientific Sessions. “We are not succeeding in implementation of the things that we know. We need to bring these things together so that we harness technology, particularly digital technology and AI [artificial intelligence], to the benefit of the people that we care about.” * * *
    • “High fasting glucose, poor diet, and high BMI are all in the top five factors behind death and loss of disability-adjusted life years in the U.S. And according to some sources, diabetes has now surpassed cancer as the leader in the economic cost of healthcare in the U.S., with some 34 million adults having some form of diabetes in 2020, he said. “This is an honor I’m not sure I’d want to have, but it does give you a lot of power to do things to make this better.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services June 24 released a final rule that would disincentivize health care providers for interfering with the access, exchange or use of electronic health information. AHA previously expressed concern when the rule was proposed, saying it could threaten the financial viability of economically fragile hospitals.”
    • “In the final rule, hospitals under the Medicare Promoting Interoperability Program found to have committed information blocking would experience a reduction of the market basket update by 75%. Critical access hospitals would see a reduction from 101% to 100% of reasonable costs, while clinicians in Medicare’s Merit-based Incentive Payment System would receive a score of zero in the MIPS Promoting Interoperability performance category. Providers in accountable care organizations that commit information blocking would be ineligible to participate in the Medicare Shared Savings program for at least one year and may not receive revenue they may have earned through the program.” 
  • HHS adds,
    • “This HHS final rule complements OIG’s final rule from June 2023 that established penalties for information blocking actors other than health care providers, as identified in the Cures Act (health information technology (IT) developers of certified health IT or other entities offering certified health IT, health information exchanges, and health information networks). If OIG determines that any of these individuals or entities committed information blocking, they may be subject to a civil monetary penalty of up to $1 million per violation.
    • “The Office of the National Coordinator for Health Information Technology (ONC) and CMS will host a joint information session about the final rule on June 26, 2024, at 2 pm ET. More information can be found at healthit.gov/informationblocking and via ONC’s X account, @ONC_HealthIT 
  • Per Govexec,
    • “The U.S. Postal Service is not living up to its projected cost savings from its plan to overhaul the agency, according to a new [USPS Inspector General] audit, which found the 10-year initiative is no longer offering insight for measuring the success of the reforms. 
    • “USPS is bringing in more revenue than it anticipated when it first laid out its Delivering for America plan in 2021, though its costs have also accelerated in a way it did not project. That has led to overall losses of $950 million in fiscal 2022 and $6.5 billion in fiscal 2023, despite postal management predicting it would have broken even by now.” 
  • Fierce Healthcare lets us know,
    • “The [U.S.] Supreme Court will not hear a legal challenge to the nearly $2.7 billion Blue Cross Blue Shield [antitrust] settlement. * * *
    • In a statement to Reuters, BCBSA said it welcomes the decision as well as “the opportunity to begin to implement this settlement.”

From the public health and medical research front,

  • BioPharma Dive points out
    • “An experimental medicine helped people with a deadly heart disease stay out of the hospital and live longer in a closely watched clinical trial, a finding that could pave the way for a regulatory approval and help its developer, Alnylam Pharmaceuticals, rebound from a significant setback.
    • “Trial data released Monday showed trial participants with the disease, transthyretin amyloidosis cardiomyopathy, and treated with Alnylam’s drug had a 28% lower risk of death from any cause or recurrent cardiovascular event, compared to those given a placebo. Alnylam said its drug was associated with a 33% risk reduction versus placebo among people who weren’t on another drug for the condition, Pfizer’s tafamidis, at the study’s start.”
  • and
    • “Novo Nordisk on Sunday disclosed detailed clinical trial results for an experimental hemophilia treatment dubbed Mim8, showing once-weekly and once-monthly doses of the antibody drug controlled bleeding in people with the more common “A” form of the disorder.
    • “The data, which were presented at the International Society on Thrombosis and Haemostasis Annual Congress in Thailand, fill in a positive picture for Mim8’s effectiveness and safety. Novo had said in May that the Phase 3 trial, called Frontier-2, succeeded and shared topline findings.
    • “Among people who had not previously been on preventive treatment, researchers reported zero bleeds in 86% of study participants who received once-weekly Mim8, and 95% of those given the once-monthly dose. Those figures were 66% and 65%, respectively, among people in the trial who had prior preventive treatment.”
  • Per MedTechDive,
    • “Insulet is looking to expand the label for its Omnipod 5 insulin pump for people with Type 2 diabetes. The company said Friday it recently filed with the Food and Drug Administration. 
    • “Insulet presented study results at the American Diabetes Association’s 84th Scientific Sessions that evaluated Omnipod 5 in people with Type 2 diabetes who were taking basal insulin or multiple daily injections. The results showed “substantial improvements in blood glucose outcomes and overall quality of life,” said study chair Francisco Pasquel, an associate professor of endocrinology at Emory School of Medicine.
    • “Insulet’s filing comes as other diabetes technology companies look to expand their offerings for people with Type 2 diabetes. Tandem Diabetes Care has published results showing how its T:slim x2 pump with Control IQ improved time in range for people with Type 2 diabetes, and Dexcom and Abbott recently gained FDA clearance for continuous glucose monitors tailored for people with Type 2 who don’t take insulin.”
  • Per Beckers Hospital Review,
    • “Orlando, Fla.-based AdventHealth Cancer Institute launched a first-of-its-kind bladder cancer vaccine trial that will use patient-customized mRNA vaccines.
    • “The Phase II trial participants will receive pembrolizumab combined with a customized immunotherapy injection designed using the unique proteins present in each patient’s tumors, according to a May 23 system news release. Participants will receive infusions every six weeks for one year and then receive one vaccine injection every three weeks for nine doses.
    • “This vaccine is precision medicine at its best,” Guru Sonpavde, MD, medical director of genitourinary oncology at the AdventHealth Cancer Institute, as well as a member of the trial’s global steering committee, said in the release.”
  • The Centers for Disease Control last week released a report on loneliness in the U.S. 2022. The study found that loneliness was most prevalent among sexual and gender minorities.
  • STAT News notes,
    • “New research shows that, in spite of recommendations discouraging use of aspirin in primary prevention of cardiovascular disease among older adults, nearly a third of adults 60 years and older are still using it for this very purpose.
    • “The study, published on Monday in Annals of Internal Medicine, found that 18.5 million adults 60 and older without cardiovascular disease reported using preventative aspirin in 2021. Of those, 3.3 million were using the pills without medical advice. * * *
    • “John Wong, vice chair of the USPSTF, emphasized increased physician-patient conversations in deciding how to best prevent cardiovascular disease. “There are things at the individual level our population evidence-based recommendations don’t take into account,” Wong said.
    • “If a patient and their physician decide that daily aspirin is too risky, they can still plan to manage obesity, stop smoking, and regularly screen for high blood pressure and metabolic disease, said Wong. “Those are all evidence-based, proven methods to prevent that first heart attack or first stroke.”
  • Scientific American discusses exercises that can help older Americans reduce the risk of dangerous falls.
  • The Washington Post and Consumer Reports offer “tips can help you move [heavy] objects safely — and with less effort — even as you get older.

From the U.S. healthcare business front,

  • Fierce Healthcare explores UnitedHealthcare’s top selling health insurance product Surest.
  • Beckers Hospital Review explains why “Walgreens is on a mission to attain provider status for its pharmacists.” 
  • FiercePharma reports,
    • “GLP-1 heavyweights Eli Lilly and Novo Nordisk are trading haymakers as they scale up production to meet the overwhelming demand for their revolutionary obesity drugs.
    • “A month after Lilly revealed a $5.3 billion investment to increase its manufacturing capacity, Novo has answered.
    • “On Monday, the Danish drugmaker said it will spend $4.1 billion to construct a second fill-finish plant at its sprawling campus in Clayton, North Carolina. At 1.4 million square feet, the site will match the combined floor space of Novo’s three current manufacturing sites in the state, the company said.
    • “At the new plant, Novo will produce blood sugar modulating treatments Ozempic, for diabetes, and Wegovy, for obesity. The outlay is part of Novo’s planned $6.8 billion investment in manufacturing this year, up from $3.9 billion in 2023.”     

Friday Factoids

David Ermer–AHRQ, CDC, Congress, Employee Wellness Programs, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • STAT News reports,
    • “A House panel is exploring holding a vote on scaled-back versions of two major health care bills that would expand Medicare’s coverage of cancer screening tests and hugely popular weight loss drugs, five sources familiar with the planning told STAT. * * *
    • The two pieces of legislation are the Treat and Reduce Obesity Act, which would allow Medicare to cover obesity drugs and enable more health care providers to provide intensive behavioral therapy for obesity to Medicare patients, and the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which would allow Medicare to cover multi-cancer blood tests to screen healthy people for cancer. * * *
    • “Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government. If the House Ways and Means Committee is able to scale back the measures to a more palatable price point, it could increase their chance of passage.
    • “It is unclear how the bills could be limited to decrease their cost, and whether such pared-down proposals could achieve the bipartisan support that would be necessary to make the bills candidates for inclusion in a health care package that’s expected at the end of the year.”
  • BioPharma Dive informs us,
    • “Peter Marks is again at the center of a controversial Food and Drug Administration decision on a gene therapy for Duchenne muscular dystrophy. Twice now, the high-ranking FDA leader has pushed aside objections from agency reviewers to grant an approval to Sarepta Therapeutics’ treatment for the muscle-wasting condition.
    • “On Thursday, the FDA substantially broadened use of that treatment, called Elevidys. The decision makes Elevidys available to approximately 80% of people in the U.S. with Duchenne, which has limited treatment options and no cure. The agency also converted Elevidys’ accelerated approval to full, securing its place on the market. Previously, Elevidys was only approved for a specific group of boys 4 or 5 years of age.
    • “[D]ocuments published by the FDA expose a rift within the agency over Elevidys. Three FDA review teams and two top officials recommended Sarepta’s application be rejected due to insufficient and conflicting clinical data. They were overruled by Marks, head of the FDA center that reviews gene therapies, who found the results supportive enough to broaden Elevidys’ label. It’s now cleared for Duchenne patients over the age of 4 with mutations to a specific gene, regardless of whether they can still walk.
    • “I come to a different conclusion regarding the overall interpretation of the data,” Marks wrote in a memo. * * *
    • “The lasting impact of the approval will likely shape the FDA and gene therapy space for some time,” wrote Tim Lugo, an analyst at the investment bank William Blair, in an investor note Thursday. “We believe a more patient focused and less adversarial FDA review process is likely to continue across several areas in the agency, especially for heterogenous and deadly diseases with few good treatment options.”
  • This morning, the 5th Circuit issued in its opinion in a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) to make binding preventive services recommendations under the Affordable Care Act. The Court agreed with the lower court that USPSTF members are principal officers of the U.S. due to the binding nature of their recommendations. (HHS argued unsuccessfully that they were inferior officers.). Under the Constitution, the President must appoint principal officers with the advice and consent of the Senate. 
  • The Court granted relief to the individual plaintiffs but rejected the district court’s grant of universal injunction against enforcement of USPSTF recommendations since ACA enactment. The Court remanded the case to the district court for further proceedings.
  • The political ball is in the Biden Administration’s court.

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • “COVID-19
      • “COVID-19 test positivity has increased to 6.6% from 5.4% in the previous week. Emergency department visits for COVID-19 are also increasing nationally. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 39 states and territories, declining or likely declining in 0 states or territories, and are stable or uncertain in 10 states and territories, based on CDC modeled estimates of epidemic growth. KP.3 and LB.1 are projected to continue increasing as proportions of the variants that cause COVID-19 (CDC COVID Data Tracker: Variant Proportions).
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • Health Day lets us know,
    • “A medication used to manage type 2 diabetes has been found effective in treating sleep apnea.
    • “The worldwide clinical trial demonstrates that tirzepatide significantly lowers breathing interruptions during sleep, a key indicator of the severity of a patient’s obstructive sleep apnea (OSA).
    • “Tirzepatide is one of the class of blockbuster GLP-1 medicines, sold as Mounjaro to fight diabetes and as Zepbound to help with weight loss.
    • “This study marks a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said study leader Dr. Atul Malhotra, director of sleep medicine at UC San Diego Health. * * *
    • “The findings, published June 21 in the New England Journal of Medicine, add to evidence that a drug targeting both apnea and obesity is better than treating either condition on its own. Researchers said the drug therapy improved other aspects related to OSA, such as improving weight. Some patients, however, had mild stomach issues.”
  • Medscape notes, “Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.”
  • The Assistant Secretary of Labor for Employee Benefit Security writes in her blog that “For Men, Taking Care of Your Family Means Taking Care of Yourself.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Risant Health, a nonprofit formed under Oakland, Calif.-based Kaiser Permanente, has signed a definitive agreement to acquire Greensboro, N.C.-based Cone Health.
    • “The news comes less than three months after Risant acquired its first health system, Danville, Pa.-based Geisinger Health. 
    • “If the transaction closes, Cone Health will operate independently as a regional and community-based health system under Risant, which supports organizations with technology and services to improve outcomes and lower care costs in diverse business models.
    • “Cone Health’s impressive work for decades in moving value-based care forward aligns so well with Risant Health’s vision for the future of healthcare. Their longstanding success and deep commitment to providing high-quality care to North Carolina communities make them an ideal fit to become a part of Risant Health,” CEO, Jaewon Ryu, MD, said in a June 21 news release. “We will work together to share our industry-leading expertise and innovation to expand access to value-based care to more people in the communities we serve.” 
    • “Cone Health includes four acute-care hospitals, a behavioral health facility, three ambulatory surgery centers, eight urgent care centers and more than 120 physician practices, according to its website. It has more than 13,000 employees and over 700 physicians, along with 1,800 partner physicians.” 
  • Per Healthcare Dive,
    • “Steward Health Care this week pushed back the auction timeline for the sale of its physician group and about half of its hospitals — less than a week before bids were due.
    • “The delay impacts the sale of Arizona and Massachusetts hospitals as well as the St. Joseph Medical Center in Texas. The new deadline for bids is July 15, with an auction following July 18 and a proposed sales hearing on July 31. Steward did not change the timeline for the sale of its other assets.
    • “One expert told Healthcare Dive it was “very possible” Steward would delay the sale timeline again if creditors agreed it was the best business move — especially since the company just re-upped its debtor-in-possession financing, which provides cash to fund operations through restructuring.”
  • and
    • “Telehealth use declined across most sociodemographic groups from 2021 to 2022, according to a survey published Thursday by the National Center for Health Statistics.
    • “Thirty-seven percent of adults reported using telemedicine in the past 12 months in 2021, compared with just over 30% in 2022.
    • “Researchers noted the decline across nearly all groups studied, including sex, family income, education and region. Women, adults with at least a college degree and people living in more urban areas were more likely to use telehealth in 2022.” 
  • Per Fierce Healthcare,
    • “An innovation council brought together some of the nation’s largest health plans to raise issues and look for ways to improve complex processes, including credentialing and provider data management.
    • “It’s one of the first times payers have sat down together to solve these pain points, CAQH CEO Sarah Ahmad told Fierce Healthcare in an interview. The health plan representatives met in-person just one day before AHIP 2024 kicked off in Las Vegas last week.
    • “You don’t see that in healthcare these days,” said Ahmad, whose company assembled the leaders.
    • “CAQH is a provider data management company that works on the provider side to credential and handle directory management, and on the member side to handle coordination of benefits.”
  • HR Dive offers five stories on the rise of wellness benefits.

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.

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.”


Weekend Update

David Ermer–CDC, Congress, COVID-19, Medicare, NIH, U.S. Healthcare–

From Washington, DC,

  • Last Thursday, June 13, the House Appropriations Committee met to consider “Fiscal Year 2025 Financial Services and General Government Appropriations Act.” The measure was approved by the Committee with a vote of 33 to 24. The Committee adopted an amendment that “Requires the Office of Personnel Management (OPM) to submit a report on the coverage options currently available to federal employees that include assisted reproductive technology services and procedures.” 
  • Healthcare Dive tells us,
    • “Members of Congress are questioning the CMS Innovation Center’s progress in moving the nation’s health system to value-based care after a report found the center has increased federal spending instead of lowering it.”
    • “The Center for Medicare and Medicaid Innovation, or CMMI, was created by the Affordable Care Act more than a decade ago. The center is tasked with testing new healthcare payment and delivery models to lower costs and improve quality in government health programs.
    • “However, during at House Energy and Commerce subcommittee hearing on Thursday, some lawmakers — particularly Republicans — stressed that CMMI has failed to save money during its first 10 years and could continue to increase spending over the next decade. * * *
    • “Some legislators raised concerns about a lack of provider input into CMMI models. But a new strategic direction for CMMI, announced in 2021, should improve transparency and lay out the center’s priorities, Fowler said.
    • “Many stakeholders, including healthcare providers and various industry stakeholders, have expressed concern about the complexity, administrative burden and perceived lack of transparency involved when participating in the CMMI models,” said Rep. Bob Latta, R-Ohio.”
  • The American Medical Association lets us know,
    • “Just months after Congress again failed to stop in its entirety a pay cut that threatens Medicare patients’ access to high-quality physician care, the AMA House of Delegates made crystal clear the imperative to step up the pressure on the nation’s lawmakers and boost patient awareness about the dire need for Medicare payment reform.
    • “In a federal budget deal struck to continue operating the government, Congress in March reduced to less than 2% the 3.37% across-the-board physician pay cut that took effect in January.
    • “The House of Delegates (HOD) directed the AMA to:
      • “Increase media awareness around the 2024 AMA Annual Meeting about the need for Medicare payment reform, eliminating budget-neutrality reductions, and instituting annual cost-of-living increases.
      • ‘Step up its public relations campaign to get more buy-in from the general public about the need for Medicare payment reform.
      • “Increase awareness to all physicians about the efforts of our AMA on Medicare payment reform.
      • “Advocate for abolition of all Merit-based Incentive Payment System (MIPS) penalties in light of the current inadequacies of Medicare payments.
    • “This direction from the HOD bolsters the AMA’s aggressive efforts in leading the charge to reform the Medicare payment system.

From the public health and medical research front,

  • The Hill takes a look at the CDC’s current Covid statistics. Here’s the sentence that grabbed the FEHBlog’s attention: “[H]ospitalizations for COVID-19 remain very low nationwide. Only 0.6% of all emergency department visits were diagnosed as COVID cases last week.
  • A Buffalo, NY, television station WGRZ offers tips on how to reduce the risk of falling as you age, which is useful information for FEHB plans to share given the FEHB’s older demographics.
  • The National Institutes of Health announced today,
    • A data-driven intervention that engaged communities to rapidly deploy evidence-based practices to reduce opioid-related overdose deaths – such as increasing naloxone distribution and enhancing access to medication for opioid use disorder – did not result in a statistically significant reduction in opioid-related overdose death rates during the evaluation period, according to results(link is external) from the National Institutes of Health’s HEALing (Helping to End Addiction Long-Term) Communities Study. Researchers identified the COVID-19 pandemic and increased prevalence of fentanyl in the illicit drug market – including in mixtures with cocaine and methamphetamine – as factors that likely weakened the impact of the intervention on reducing opioid-related overdose deaths.
    • The findings were published in the New England Journal of Medicine and presented at the College on Problems of Drug Dependence (CPDD) meeting on Sunday, June 16, 2024. Launched in 2019, the HEALing Communities Study is the largest addiction prevention and treatment implementation study ever conducted and took place in 67 communities in Kentucky, Massachusetts, New York, and Ohio – four states that have been hard hit by the opioid crisis.
  • STAT News promptly followed up with an article about this NIH announcement.
    • “In statements, federal health officials cast the study as at least a partial victory. While the interventions did not meaningfully reduce overdose deaths, the officials argued, they set the stage for future action and created a framework to help hard-hit communities choose new policy approaches and begin to implement them, with the hope that with more time and without Covid-19, deaths would fall.  “In statements, federal health officials cast the study as at least a partial victory. While the interventions did not meaningfully reduce overdose deaths, the officials argued, they set the stage for future action and created a framework to help hard-hit communities choose new policy approaches and begin to implement them, with the hope that with more time and without Covid-19, deaths would fall.  
    • “[Nora] Volkow, the NIDA director, said that increasing use of stimulants like methamphetamine and cocaine, and the proliferation of fentanyl, mean society must “continue developing new tools and approaches” for preventing overdose deaths. Miriam Delphin-Rittmon, the administrator of the Substance Abuse and Mental Health Services Administration, said the study “recognizes there is no quick fix.” 
    • “And in an interview, [Redonna] Chandler, the director of the study, stressed that the results should not challenge what research has long demonstrated: There is a “mountain of evidence,” she said, supporting the belief that tools like naloxone, medications for opioid use disorder, and safer prescribing techniques, save lives. The challenge, Chandler said, lies in implementation — not the strategies themselves. 
    • “The study released Sunday, she said, “doesn’t negate, in any way, the evidence that suggests the strengths of those interventions.”

Happy Flag Day!

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, No Surprises Act, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal confirms,
    • “The federal government plans to redo this year’s quality ratings of private Medicare plans, a move that will deliver hundreds of millions in additional bonus payments to insurers next year.
    • “The decision by the Centers for Medicare and Medicaid Services was announced late Thursday, after The Wall Street Journal reported the agency’s plans. 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.
    • “The agency said it would recalculate all of the 2024 quality ratings, but only apply the results if a plan’s ratings go up under the new methodology. If a plan’s ratings go down, the change won’t be implemented, CMS said in a guidance document.”
  • STAT News reports,
    • “Novo Nordisk CEO Lars Fruergaard Jørgensen will testify before the Senate after Sen. Bernie Sanders threatened to subpoena the company over its pricing of the popular diabetes drug Ozempic and the obesity drug Wegovy, the Senate health committee announced Friday.
    • “The agreement is a finale to a farcical public back-and-forth over apparent difficulties between the Senate health committee and Novo in scheduling a hearing. Sanders’ team claimed that Novo was uncooperative with his requests, but the company said they had told the senator’s team that the company was willing to testify.”
  • The American Hospital Association News lets us know,
    • “The Departments of Health and Human Services, Labor and the Treasury today announced a 120-day extension for parties impacted by the cyberattack on Change Healthcare to open disputes under the No Surprises Act independent dispute resolution process. Parties have until Oct. 12 to file disputes and must attest that their ability to open a dispute was impacted by the incident, the Centers for Medicare & Medicaid Services said. The departments published an attestation that parties must submit along with the standard IDR form during the extension period. The AHA previously advocated for the departments to create the extension.”
  • Bloomberg News adds,
    • “Medical providers continue to beat out insurers in most surprise billing arbitration disputes, often pocketing awards of at least double the in-network rate for a given service, according to new federal agency data.
    • “Providers were the prevailing party in about 82% of payment determinations made in No Surprises Act arbitration in the second half of 2023, according to a data report released Thursday by the Centers for Medicare and Medicaid Services. A total of 125,478 disputes resulted in award decisions in that period, the report showed, a 50% increase from the first half of 2023.”
  • Per a Department of Health and Human Services press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced notices of funding opportunities aimed at improving behavioral health for racial and ethnic minorities, and other underserved populations, providing training and technical assistance to programs serving these populations, and integrating primary and behavioral health care. The funding totals $31.4 million and supports the Biden-Harris Administration’s efforts to address the mental health and overdose crises, two key pillars of the President’s Unity Agenda for the nation, as well as continuing efforts to advance heath equity and address the consistent and disproportionate impact of HIV on racial and ethnic minorities.  
    • “These grant programs additionally support HHS’ Overdose Prevention Strategy, the HHS Roadmap for Behavioral Health Integration, and SAMHSA’s strategic priorities: preventing substance use and overdose; enhancing access to suicide prevention and mental health services; promoting resilience and emotional health for children, youth, and families; integrating behavioral and physical health care; and strengthening the behavioral health workforce. ”   
  • The Labor Department’s Assistant Secretary for Employee Benefit Security, Lisa Gomez, writes in her blog about “avoiding elder financial abuse.”

From the public health and medical research front,

  • The Centers for Disease Control tells us today,
    • “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 5.4% from 4.6% in the previous week. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 34 states and territories, declining or likely declining in 1 state or territory, and are stable or uncertain in 14 states and territories, based on CDC modeled 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 activity remains low.
    • “Vaccination
  • Radiology Business informs us,
    • “Gen X is experiencing larger cancer incidence increases than generations before it, according to a new analysis published Monday in JAMA Network Open.
    • “Increases among this group (born between 1965 to 1980) are “substantial” when compared to the baby boomers who came before them (1936 to 1960). For instance, Gen X Hispanic women have seen a nearly 35% increase in cancer incidence while Latino men have recorded a 14% uptick.
    • “The findings are based on an analysis of data from 3.8 million individuals with invasive cancer.”
    • “The substantial increases we identified in Generation X versus both the baby boomers and their proxy parents surprised us,” lead author Philip S. Rosenberg, PhD, principal investigator at the National Cancer Institute, wrote June 10. “Numerous preventable causes of cancer have been identified. Cancer control initiatives have led to substantial declines in tobacco consumption. Screening is well accepted for precancerous lesions of the colon, rectum, cervix, uterus and breast. However, other suspected carcinogenic exposures are increasing.”
    • “For the study, Rosenberg and the NCI’s Adalberto Miranda-Filho, PhD, gathered data from the institute’s Surveillance, Epidemiology and End Results (SEER) Program spanning 1992-2018. They used a tool called the age-period-cohort model to project cancer incidence among the varying generations.”
  • Health Day notes,
    • “The death rate for type 1 diabetes has fallen 25% over the past few decades, and there are more seniors than ever with the illness
    • “Uncontrolled blood sugar was the prime driver behind poor outcomes with type 1.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Lilly’s Weight-Loss Drug Is a Huge Hit. Its CEO Wants to Replace It ASAP.
    • “Dave Ricks is pushing his scientists to find an even more potent anti-obesity treatment. ‘Lilly’s got a lead, and we plan to exploit that lead.’”
  • Beckers Hospital Review explains how “Kaiser Permanente’s phone and video visit rates remain significantly higher than pre-pandemic levels.” Check it out.
  • mHealth Intelligence relates,
    • “Most Americans said they would be willing to participate in hospital-at-home programs to return home sooner, according to a new survey.
    • “The survey, conducted by remote patient monitoring (RPM) technology developer Vivalink, polled 1,025 United States adults over 40.
    • “An overwhelming majority of US adults are likely to participate in a hospital-at-home monitoring program to get back home more quickly, with 39.15 percent saying they are very likely and 45.27 percent saying they are somewhat likely to participate in these programs. Only 15.58 percent said they are not likely to participate in a hospital-at-home program to return home sooner.”
  • Per BioPharma Dive,
    • “AbbVie is securing its place in an emerging gastrointestinal disease drug field, paying China-based FutureGen Biopharmaceutical $150 million in immediate and near-term fees for rights to an antibody drug targeting TL1A, a molecule linked to heightened immune responses in inflammatory bowel disease.
    • “The Illinois-based drugmaker is following rivals like Merck, Roche, Teva and Sanofi, which have piled billions of dollars into acquisitions to gain ownership of TL1A-targeting drugs.
    • “Per terms of the deal announced Thursday, AbbVie will gain global rights to the drug, called FG-M701, and will be responsible for its development, manufacturing and commercialization. FutureGen could receive up to $1.56 billion in additional fees based on hitting development, regulatory and sales milestones.”
  • and
    • “The failure of a Pfizer medicine for Duchenne muscular dystrophy adds new uncertainty around the effectiveness of gene therapy for the muscle-wasting condition, days before the Food and Drug Administration is expected to decide on expanding use of a similar treatment from Sarepta Therapeutics.
    • “On Wednesday, Pfizer said the treatment missed its mark in a definitive Phase 3 study of boys between 4 and 7 years of age with Duchenne. Pfizer didn’t disclose specifics, but said the therapy didn’t lead to a significant difference versus placebo on a measure of motor function, or on key secondary measures such as timed tests for how quickly study participants could stand or walk. The results will be presented at future medical and patient advocacy meetings.”
    • “The study’s failure makes it much less likely there will soon be a second gene therapy option for people with Duchenne, a progressive and deadly condition with no cure and limited treatment options. Pfizer had previously expected to file for a regulatory approval of its medicine if study results were positive. Now the company says it is “evaluating appropriate next steps” for the program. Multiple Wall Street analysts expect Pfizer to discontinue research.
    • “The results are “a discouraging blow to our community, particularly devastating to those who participated in the study,” said Parent Project Muscular Dystrophy, a patient advocacy group, in a statement.”

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.”

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.”

Midweek Update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The House Appropriations Committee tells us, “Today, the House Appropriations Financial Services and General Government Subcommittee met to consider its Fiscal Year 2025 bill. The measure was approved by the Subcommittee.”
  • This bill provides appropriations for OPM and the FEHBP. The Committee summary of the bill describes its OPM appropriations as follows —
    • “Provides $477 million for the Office of Personnel Management (OPM), which is $31.4 million below the FY25 Budget Request and $29.1 million above the FY24 enacted level.”
  • Govexec informs us,
    • “Senate Democrats have vowed to move quickly on legislation protecting Americans’ access to in vitro fertilization and other forms of assistive reproductive technology, including a provision expanding federal workers’ access to those treatments as part of the government’s employer-sponsored health insurance program.
    • “On Monday, Sens. Tammy Duckworth, D-Ill., Patty Murray, D-Wash., and Cory Booker, D-N.J., introduced the Right to IVF Act, a repackaging of three separate previously introduced bills on reproductive health services.
    • “Included is the Family Building FEHB Fairness Act, first introduced last year by Duckworth, which would require the Federal Employees Health Benefits Program to cover additional costs associated with IVF, and would expand coverage to all types of assisted reproductive technology, such as gamete and zygote intrafallopian transfer.”
  • Govexec also pointed out this OPM Inspector General brief that summarizes OPM OIG recommendations that have been open for more than six months as of March 31, 2024. The FEHBlog understands why the FEHB open recommendations remain outstanding
  • Healthcare Dive lets us know,
    • “Congress appears to be inching toward injecting more transparency into a controversial program that forces drugmakers to give safety-net hospitals steep discounts on drugs.
    • “It would be a win for pharmaceutical manufacturers, which have long lobbied that hospitals be required to account for their savings in the 340B program — or that it be overhauled entirely.
    • “The latter appears unlikely, after lawmakers on both sides of the aisle expressed blanket support for 340B during a House Oversight and Investigations subcommittee hearing on Tuesday. However, members said they approved of more oversight to try and stop financial gaming in the program.
    • “Though “we’re all in support of 340B … I think nearly all of us agree that the status quo is not acceptable,” said Rep. Larry Bucshon, R-Ind.”
  • Yesterday, the U.S. Preventive Services Task Force released a final recommendation concerning “Falls Prevention in Community-Dwelling Older Adults: Interventions.” Its recommendations align with the recommendations currently in force.
  • Thompson Reuters Practical Law relates,
    • “In litigation under the No Surprises Act (NSA), a district court concluded that there is no cause of action for health providers to enforce awards involving surprise billing disputes under the NSA’s independent dispute resolution (IDR) process (Guardian Flight LLC & Med-Trans Corp. v. Health Care Serv. Corp., (N.D. Tex. May 30, 2024)).”
  • The American Hospital Association News shares the organization’s “comments [submitted’ June 5 on the Centers for Medicare & Medicaid Services’ inpatient prospective payment system proposed rule for fiscal year 2025, expressing support for several provisions, including certain policies supporting low-volume and Medicare-dependent hospitals, and several aspects of CMS’ quality-related proposals. However, AHA raised concerns about the rule’s proposed payment updates.”

From the public health and medical research front,

  • CNN reports,
    • “About 61% of US adults will have cardiovascular disease by 2050, new research from the American Heart Association predicts. The biggest driver of this trend will be the large number of people who have or will develop high blood pressure, which makes them much more likely to develop dangerous problems like a heart attack or stroke.
    • “Other cardiovascular problems include heart attacks, arrhythmias like atrial fibrillation or a-fib, heart failure and congenital heart disease. * * *
    • In the research published Tuesday, the association predicts that 45 million adults will have some form of cardiovascular disease – excluding high blood pressure – or will have a stroke in 2050, up from 28 million in 2020.
  • The New York Times reports,
    • One of the nation’s premier medical advisory organizations has weighed in on long Covid with a 265-page report that recognizes the seriousness and persistence of the condition for millions of Americans.
    • More than four years since the start of the coronavirus pandemic, long Covid continues to damage many people’s ability to function, according to the National Academies of Sciences, Engineering and Medicine, a nongovernmental institution that advises federal agencies on science and medicine.
  • and
    • “A committee of advisers to the Food and Drug Administration voted on Wednesday to update the formula for the Covid vaccine ahead of an anticipated fall immunization campaign, now an annual step to try to offer better protection against versions of the virus in circulation.
    • “The unanimous vote by the 16 advisers recommends a formula aimed at combating the variant JN.1, which dominated infections in the United States in February, or a version of it. In recent weeks, JN.1 has been overtaken by descendants known as KP.2 and KP.3.
    • “In the coming weeks, the F.D.A. is expected to formally recommend a variant target for vaccine makers for the next round of shots in the late summer or early fall. Any decision involves some educated guesswork, given that any new vaccine formula won’t be available until months after a variant becomes dominant.
    • “It’s becoming clear that the ideal timing for a vaccine composition decision remains elusive,” said Jerry Weir, an official with the F.D.A.’s vaccine division.”
  • Per Biopharma Dive,
    • “A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.”A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.
    • “Data presented at the American Society of Clinical Oncology annual meeting suggest the test can support prostate cancer diagnosis in people who are missed by other screening methods.
    • “The researchers are now comparing the saliva test to several screening methods such as fast MRI scans and prostate-specific antigen (PSA) blood tests to determine the best approach.”
  • and
    • “Eli Lilly’s drug tirzepatide — sold as Zepbound for obesity — continues to show promise in the liver disease MASH. Clinical trial data disclosed in an abstract ahead of a European medical conference indicates that, after one year, the shot helped improve liver fibrosis without worsening MASH in just over half of treated participants, compared with 30% of those given placebo. Lilly had hinted at the study’s success earlier this year, but the full data will provide a more complete view of tirzepatide’s potential. The abstract’s release comes one day after Viking Therapeutics released trial data for its MASH pill VK2809 and less than two months after Madrigal Pharmaceuticals won U.S. approval of the first MASH drug.”
  • The Institute for Clinical and Economic Research “today posted a Protocol outlining how it will conduct the fourth annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. These standards were developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies.”
  • Per MedPage Today,
    • “The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).”The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).
    • “Healthcare providers should discuss and offer doxy PEP to people in these populations with a history of at least one bacterial STI — specifically syphilis, chlamydia, gonorrhea — in the last 12 months, Lindley Barbee, MD, of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, and colleagues wrote in Morbidity and Mortality Weekly Report.”
    • “Doxy PEP represents the first new STI prevention tool in decades, at a time when innovation in the nation’s fight against STIs is desperately needed,” said Barbee in a CDC statement.
  • The National Institutes of Health announced,
    • “The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”
  • The Washington Post reports, “Male birth control gel shows promise in early-stage clinical trials. “A National Institutes of Health official said the findings marked a milestone, even if the product is probably years away.”

From the U.S. healthcare business front,

  • KFF informs us,
    • The Medical Loss Ratio (MLR) provision of the Affordable Care Act (ACA) limits the amount of premium income that insurers can keep for administration, marketing, and profits. Insurers that fail to meet the applicable MLR threshold are required to pay back excess profits or margins in the form of rebates to individuals and employers that purchased coverage.
    • In the individual and small group markets, insurers must spend at least 80% of their premium income on health care claims and quality improvement efforts, leaving the remaining 20% for administration, marketing expenses, and profit. The MLR threshold is higher for large group insurers, which must spend at least 85% of their premium income on health care claims and quality improvement efforts. MLR rebates are based on a 3-year average, meaning that rebates issued in 2024 will be calculated using insurers’ financial data in 2021, 2022 and 2023 and will go to people and businesses who bought health coverage in 2023.
    • This analysis, using preliminary data reported by insurers to state regulators and compiled by Mark Farrah Associates, finds that insurers estimate they will issue a total of about $1.1 billion in MLR rebates across all commercial markets in 2024. Since the ACA began requiring insurers to issue these rebates in 2012, a total of $11.8 billion in rebates have already been issued to individuals and employers, and this analysis suggests the 2012-2024 total will rise to about $13 billion when rebates are issued later this year.
  • TechTarget calls our attention to the fact that “As providers seek to advance patient-centered care, many behavioral health organizations are turning to their EHR vendors to support integrated care models, according to a KLAS report.” Yippee.
  • Beckers Hospital Review lets us know,
    • “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. 
    • “The sales will be conducted in two rounds. The first round, which includes the health system’s physician group, Stewardship Health, and all Steward hospitals excluding its Florida facilities and some of the Texas hospitals, will have a bid deadline of June 24 and a first sale hearing July 11.
    • “The second round includes Steward’s Florida hospitals and four of its Texas facilities, with a bid deadline of Aug. 12 and a sale hearing of Aug. 22.”
  • Beckers Payer Issues tells us about the payers that landed on the 2024 Fortune 500.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, NIH, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital Association New tells us,
    • The House Energy and Commerce Oversight and Investigations subcommittee June 4 hosted a hearing to discuss oversight of the 340B Drug Pricing Program. AHA sent a letter to the subcommittee for the hearing, urging Congress to protect the program and highlighted its value to hospitals and health systems.
  • Roll Call offers more details on this policy issue.
  • Per a Health and Human Services press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), today welcomed 10 new states into the Certified Community Behavioral Health Clinic (CCBHC) Medicaid Demonstration Program, after they successfully developed the necessary state-level infrastructure and worked with providers in their states to develop programs that meet CCBHC standards: Alabama, Illinois, Indiana, Iowa, Kansas, Maine, New Hampshire, New Mexico, Rhode Island and Vermont. The CCBHC Medicaid Demonstration Program provides states with sustainable funding that helps them expand access to mental health and substance use services, supporting President Biden’s Unity Agenda and the Biden-Harris Administration’s efforts to tackle the country’s mental health and addiction crises. The expansion of the program directly supports the President’s national strategy to transform our behavioral health system and builds on the Administration’s previous work to build a better crisis continuum of care, including through the transition to the 988 Suicide & Crisis Lifeline, add a new mobile crisis benefit to Medicaid and new crisis codes to the Medicare program.”
  • NBC News reports,
    • A Food and Drug Administration advisory panel on Tuesday declined to recommend the approval of MDMA as a treatment for post-traumatic stress disorder, a major setback for advocates who have long pushed to include psychedelics in treating mental health disorders.
    • The two votes — one for the treatment’s efficacy and one for its safety, by the agency’s Psychopharmacologic Drugs Advisory Committee — marked the first time that FDA advisers have considered a Schedule I psychedelic for medical use. If approved by the FDA, it would be the first new treatment for PTSD in more than two decades.
    • The votes reflected panel members’ struggle to balance the need for new PTSD treatments against serious concerns about the data submitted by drugmaker Lykos Pharmaceuticals, which was marred by inconsistencies, poor study design and allegations of misconduct.
    • “It sounds like MDMA has really impacted a number of people in positive ways, but it seems that there are so many problems with the data,” said Melissa Decker Barone, an adjunct assistant professor in the department of psychiatry at the University of Maryland School of Medicine. * * *
    • Last week, the Institute for Clinical and Economic Review, a non-profit group that evaluates the cost of drugs, said patients and providers in the trial treated psychedelics “more like a religious movement than like pharmaceutical products.” * * *
    • “The decision will now go to the FDA, which is expected to make a final ruling by August 11. The committee’s vote is only a recommendation, and the agency doesn’t have to follow its advice, although it usually does.”
  • Reuters adds,
    • “The FDA’s staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain. * * *”The FDA’s staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain. * * *
    • “The FDA staff’s review for updating viral strains for vaccines in the U.S. differs from that of the World Health Organization’s advisers, who in April recommended targeting only the JN.1 strain.
    • “Since then, the subvariant KP.2 has become the dominant strain in the U.S., estimated to account for about 28.5% of cases over a two-week period ended May 25, according to data from the U.S. Centers for Disease Control and Prevention.”
  • Healthcare Dive informs us,
    • “Scan Health Plan won a lawsuit that alleged the federal government had improperly calculated its 2024 Medicare Advantage star ratings, which it argued could cost the insurer millions of dollars. “Scan Health Plan won a lawsuit that alleged the federal government had improperly calculated its 2024 Medicare Advantage star ratings, which it argued could cost the insurer millions of dollars. 
    • “The case centered around recent changes in how the CMS determined quality measures for the private Medicare plans. Scan alleged the agency didn’t follow its stated methodology, causing its rating to drop “precipitously” to 3.5 stars and risking $250 million in quality bonus payments. 
    • “The U.S. District Court for the District of Columbia ruled for the California-based insurer Monday, barring the federal government from using Scan’s original 2024 Star Rating for quality bonus decisions.”

From the public health and medical research front,

  • The New York Times reports,
    • “Surgeons removed the kidney of a genetically engineered pig from a critically ill patient last week after the organ was damaged by inadequate blood flow related to a heart pump that the woman had also received, according to officials at NYU Langone Transplant Institute.”Surgeons removed the kidney of a genetically engineered pig from a critically ill patient last week after the organ was damaged by inadequate blood flow related to a heart pump that the woman had also received, according to officials at NYU Langone Transplant Institute.
    • “The patient, Lisa Pisano, 54, who is still hospitalized, went back on kidney dialysis after the pig’s organ was removed. She lived with the transplanted organ for 47 days, Dr. Robert Montgomery, director of the institute, said. The kidney showed no signs of organ rejection.
    • “Lisa is in stable condition, and her left ventricular assist device is still functioning,” Dr. Montgomery said, referring to the heart pump. “We are hoping to get Lisa back home to her family soon.”
  • Health Day lets us know,
    • “As the H5N1 avian flu continues to spread among dairy cows in the United States, nearly 5 million doses of flu vaccine are now being prepared for possible use in humans.
    • “Since the outbreak in livestock began this spring, bird flu has been confirmed in three humans who worked on dairy farms in Texas and Michigan, and health experts are concerned the virus could mutate to the point where it could spread easily among humans.
    • “In response, vaccine maker CSL Seqirus announced last week that it has been tasked with making the additional doses of flu vaccine at its North Carolina plant.
    • “It utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response within six months of a pandemic declaration,” the company noted in a news release.”
  • ABC News relates,
    • “Cases of whooping cough are on the rise across the United States, data from the Centers for Disease Control and Prevention shows. “Cases of whooping cough are on the rise across the United States, data from the Centers for Disease Control and Prevention shows.
    • “There have been at least 4,864 whooping cough cases reported this year. This is nearly three times higher than the 1,746 cases reported at the same time last year.
    • “The number of cases for 2024 is similar to those seen in 2018-2019, before the COVID-19 pandemic.
    • “The national trends mirror those seen in many U.S. states. The Oregon Health Authority said Thursday that 178 cases have been reported as of May 29, a 770% increase from the 20 cases reported by at the same time in 2023, according to local ABC News affiliate KATU. * * *
    • “There are two types of vaccines used today to protect against whooping cough: diphtheria, tetanus, and pertussis (DTaP) vaccine for babies and children younger age 7 and tetanus, diphtheria, and pertussis (Tdap) vaccines for children aged 7 and older, adults and pregnant women.
    • “People often think ‘Well once you get vaccinated you have lifelong immunity,’ and that’s actually not the case. You certainly need to get those booster doses,” Madad said.”
  • Beckers Hospital Review points out
    • “Mississippi is the unhealthiest state in the nation for older adults in 2024, according to the United Health Foundation’s 12th annual “America’s Health Rankings Senior Report.”
    • “The May 30 report provides a comprehensive look at the health and well-being of Americans 65 and older.   
    • “State rankings were derived from 35 measures across five categories of health: social and economic factors, physical environment, behaviors, clinical care and health outcomes. The full methodology can be viewed here.“
  • The National Institutes of Health shared their most recent research insights.
  • NIH announced in various press releases,
    • “Two clinical trials have launched to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months. The studies are sponsored and funded by Gilead Sciences, Inc., and implemented through the HIV Prevention Trails Network (HPTN). The HPTN is supported by grants from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) as well as co-funding from NIDA and other NIH institutes.”
  • and
    • “A five-minute cognitive assessment coupled with a decision tree embedded in electronic medical records, known as 5-Cog, improved dementia diagnosis and care, based on a clinical trial funded by the National Institutes of Health (NIH) and conducted in an urban primary care setting. Researchers evaluated the system among 1,200 predominantly Black and Hispanic American older adults who presented to primary care with cognitive concerns. The findings appear in Nature Medicine. * * *
    • “5-Cog combines three metrics designed to test memory recall, the connection between cognition and gait, and the ability to match symbols to pictures. Importantly, these tests are easy to perform, relatively quick, and are not affected by reading level or ethnic/cultural differences among patients. * * *
    • “Cognitive impairment is often difficult to diagnose in the busy primary care setting and, as a result, beneficial care plans are likely underutilized. This can result in lack of detection, which delays the start of support services and critical planning. Underdiagnosis is even more prevalent among older Black and Hispanic patients compared to white patients, suggesting this tool may be even more valuable to the populations represented in the study.”
  • and
    • “For military members and veterans who have been diagnosed with post-traumatic stress disorder (PTSD), adding a service dog to their usual care could reduce the severity of PTSD symptoms, feelings of anxiety, and lower depression while enhancing their quality of life and psychosocial functioning, according to a study funded by the National Institutes of Health.”For military members and veterans who have been diagnosed with post-traumatic stress disorder (PTSD), adding a service dog to their usual care could reduce the severity of PTSD symptoms, feelings of anxiety, and lower depression while enhancing their quality of life and psychosocial functioning, according to a study funded by the National Institutes of Health.
    • “The trial, which is the largest nationwide study comparing service dog partnerships to usual care alone, included 156 military members and veterans diagnosed with PTSD. Participants were recruited through the database of K9s For Warriors, an accredited non-profit service dog provider. Under U.S. federal law(link is external), service dogs are “individually trained to work or perform tasks for people with disabilities.”

From the U.S. healthcare business front,

  • Per MedTech Dive,
    • “Abbott received clearance from the Food and Drug Administration for an over-the-counter glucose monitor. “Abbott received clearance from the Food and Drug Administration for an over-the-counter glucose monitor. 
    • “The device, called Lingo, first debuted in the U.K. last year as a sensor for people who don’t have diabetes to track glucose spikes. Abbott hopes to bring it to the U.S. but has shared few details about its plans. 
    • “With the recent FDA clearance, Abbott will compete with Dexcom for a new category of over-the-counter glucose monitors. Dexcom received FDA clearance for the first over-the-counter CGM in March.”
  • Per Healthcare Dive,
    • “Steward Health Care is aggressively courting new debtor-in-possession lenders to stay afloat amid its Chapter 11 restructuring process. Without additional capital, the health system says it will run out of funds by June 14.
    • “Medical Properties Trust, Steward’s landlord and initial DIP financier, appears unlikely to step up to the plate to offer more funds.
    • “The Dallas-based health system, which employs 30,000 people across eight states, declared bankruptcy last month. At the time, the real estate investment trust put up $75 million of DIP financing and said it might offer up to $225 million more, contingent upon successful asset sales.
    • “But MPT has since shown little interest in providing additional financial support for Steward. As of Friday, Steward’s attorneys told the court that MPT had made no further commitment to pony up funds, leaving the health system in immediate need of new funding.”