FEHBlog

Midweek update

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

From Washington, DC —

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

From the public health front —

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

From the Rx coverage front

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

From the U.S. healthcare business front —

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

In telehealth news,

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

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Senate Health Education Labor and Pensions Committee held its Superbugs hearing today.
  • STAT News informs us
    • “The witnesses largely seemed to organize behind the Pasteur Act in terms of how Congress should respond. This bipartisan legislation, which has been introduced in both the House and Senate, would encourage drug development by creating a subscription-style business model. In other words, the U.S. government would offer upfront payments to drugmakers in exchange for responsible stewardship policies and unlimited access to their antibiotics. A similar model has been successfully piloted in England over the past year, with the National Health Service planning a wider rollout to more pharmaceutical companies and to Northern Ireland, Scotland and Wales.
    • “The goal, as STAT has previously reported, is to enable pharmaceutical companies to recover their costs and make a profit — without predicating this on large volumes of antibiotics being prescribed. Helen Boucher, Dean of Tufts University School of Medicine, testified that this law would recognize these drugs “for their value, not for their use. It de-links incentives for overusing antibiotics.”
  • The Government Accountability Office released “a new report on the agency’s key findings and recommendations with an eye toward helping federal agencies be better prepared for future emergencies. GAO has regularly reported on the accountability and effectiveness of the federal government’s $4.7 trillion pandemic response since 2020.”
  • Per the White House,
    • “Today, in the continued efforts to fight the dangerous and deadly combination of xylazine mixed with fentanyl, the White House Office of National Drug Control Policy (ONDCP) released a National Response Plan to coordinate a whole-of-government response against this threat. Earlier this spring, ONDCP Director Dr. Gupta used an executive designation authority to designate fentanyl combined with xylazine as an emerging threat to the United States and proactively address this dangerous threat head-on.”
    • “Read the full National Response Plan to Fentanyl Combined with Xylazine HERE.
    • “Read about the Biden-⁠Harris Administration’s efforts to crack down on illicit fentanyl supply chains HERE.
    • “Read the Biden-Harris Administration’s National Drug Control Strategy HERE.”

From the public health front —

  • Federal News Network reports that twelve House of Representatives members are asking the Postal Service about steps being taken to protect letter carriers against the effects of high outdoor heat following the death of a letter carrier who passed away while delivering the mail in Texas.
    • “Eugene Gates Jr., a 66-year-old letter carrier in Texas, died June 20 while delivering mail during a heat wave with temperatures as high as 115 degrees. * * *
    • “The National Association of Letter Carriers, which represented Gates, said he collapsed and died in a customer’s yard while delivering mail. Gates, an Army veteran, served as a letter carrier for 36 years.
    • “Eugene was a dedicated letter carrier with a long and successful Postal Service career,” NALC National President Brian Renfroe said in a statement. “He will be greatly missed.”
  • STAT News tells us,
    • Weight loss medications from Novo Nordisk are being investigated by the European Medicines Agency after several reports of suicidal risks were referred to the watchdog, Bloomberg News reports. The regulator is looking at adverse events noted by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic. One additional case relating to thoughts of self-injury has been raised in connection with Saxenda. The agency is investigating the possible side effects in relation to patients who have used medicines containing the active ingredients semaglutide or liraglutide for weight loss. Novo’s hit weight loss drug Wegovy also contains semaglutide.
  • The Bloomberg article adds,
    • “Wegovy is currently available in the US with a warning and precaution for suicidal behavior and ideation on the label. While clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events, clinical trials of other weight management drugs have reported suicidal behavior and ideation, a spokesperson for the Food and Drug Administration said Monday.
    • “If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence,” the spokesperson said.”

From the medical research front,

  • According to the National Science Foundation —
    • “While it’s known that sleep plays a crucial role in strengthening memory, scientists are still decoding how the process plays out in the brain overnight.
    • “U.S. National Science Foundation-supported research led by scientists at UCLA and Tel Aviv University offers new evidence from inside the human brain supporting the dominant theory of how the brain consolidates memory during sleep.
    • “The researchers found that targeted deep brain stimulation during a critical time in the sleep cycle improved memory consolidation. The result came from a novel “closed loop” system that delivered electrical pulses in one brain region that activated the cerebral cortex, synchronized with brain activity recorded in another area, the hippocampus.
    • “The research, published in Nature Neuroscience, could offer new clues to how deep brain stimulation during sleep could help patients with memory disorders, said study co-author and physician-scientist Itzhak Fried of UCLA.”

From the Medicare front, NerdWallet identifies four Medicare policies that “should come with warning labels.” Number 1 is the Part B late enrollment penalty. The article encourages picking up Part B at the first opportunity, even if health expenses at the time are modest. Granted, this article is aimed at people, like the FEHBlog, who have Medicare without supplemental employer coverage. Nevertheless, federal employees should consider the advice too.

From the Rx coverage front

  • Beckers Hospital Review notes
    • “The FDA is allowing 10 more lots of cisplatin from a China-based pharmaceutical company to be imported to the U.S. to ease the ongoing cancer drug shortage, Bloomberg reported July 10. The additional lots are set to arrive next week. 
    • “In June, federal regulators cleared four lots of cisplatin from Qilu Pharmaceutical. While the version of the drug is unapproved in the U.S., it is similar to the approved version distributed across the country. 
    • “We will continue the importation until manufacturers can meet all needs,” Chanapa Tantibanchachai, an FDA spokesperson, told Bloomberg.
    • “Shortages of the essential cancer drug began in February and have caused some cancer centers to ration cisplatin and carboplatin, another cancer drug in shortage, treatments for patients. More recently, there have been signs of supplies stabilizing.” 
  • Fierce Healthcare discusses a recent HHS report on approaches to avoiding drug shortages.
  • Following up on its recent report about the lead-covered cabling problem in our country, the Wall Street Journal points out
    • “Supplies are running out for a key antidote for life-threatening lead poisoning.
    • “The drug, named dimercaprol, has been a go-to treatment for years for the worst cases of lead poisoning. But doctors have had to scrounge for dwindling doses since the medicine’s sole manufacturer for the U.S. declared bankruptcy in February.
    • “Now that some parts of the country don’t have any supplies left, doctors have been forced to turn to other, less preferred treatments.
    • “We’re using whatever we can get, knowing it will help, but not knowing if it’s doing as good of a job,” said Dr. Diane Calello, who directs the New Jersey Poison Control Center at Rutgers New Jersey Medical School.”

In U.S. healthcare business news

  • Beckers Payer Issues tells us
    • “The Cigna Group’s network of behavioral health providers grew by more than 30 percent in 2022, according to the company’s 2022 Environmental, Social, and Governance Report.
    • “The July report said the behavioral health network has grown to include more than 300,000 mental health and substance use providers, doubling its size over the past four years. The company also nearly doubled its virtual care network, which has grown to include more than 163,000 virtual behavioral health providers. In-network providers who support cultural and race-related counseling were increased.
    • “For behavioral health providers that specifically work with children, Cigna added 27,000 providers to its network in 2022, or an increase of 19 percent. It also increased the numbers of facilities treating children by 8 percent to 2,700 total.”
  • The Wall Street Journal delves into high-priced “clinics cater[ing] to a growing number of people obsessed with fighting aging.”
    • “Practitioners at Healthy Longevity Clinic, which has locations in Boca Raton, Fla., and Prague, build patients a personalized “longevity road map.” Those maps can include recommendations for diet, exercise, sleep and supplements. Patients are encouraged to stick with the program for at least a year, over which time their bill can run between $25,000 to more than $100,000, says Petr Sramek, the clinic’s chief executive.
    • “Longevity-clinic treatments aren’t often covered by health insurance. Some providers say they work with insurers to get coverage for medications or laboratory tests. 
    • “Many clinics use membership-based models in an effort to keep client loads low enough that providers can spend time with each patient. Others are fee-for-service or use a combination of the two.”

Monday Roundup

David Ermer–Medicare, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front

  • The New York Times reports,
    • “Drowning is the leading cause of death for children ages 1 to 4, according to the Centers for Disease Control and Prevention. Deaths are likely to surge this month, as they do every July, with children drowning just feet from their parents without a scream, struggle or splash. A 4-year-old at a Texas hotel pool, a 5-year-old in a California river, a 6-year-old at a Missouri lake and a 10-year-old at an Indiana public pool all drowned just this past week. * * *
    • “The National Institutes of Health recently published a call for research proposals to examine drowning prevention, writing that “little is known” about what intervention strategies work. The C.D.C. said it planned to do an in-depth analysis of childhood drownings in several states to better understand the contributing factors.
    • “But epidemiologists point to an array of factors that could make it increasingly difficult to close the gap, including shrinking recreation department budgets, a national lifeguard shortage and an era of distraction on pool decks as parents juggle child supervision with laptops and cellphones when they work from home.”
  • and
    • “When Dr. Benjamin Han, a geriatrician and addiction medicine specialist, meets new patients at the School of Medicine at the University of California, San Diego, he talks with them about the usual health issues that older adults face: chronic conditions, functional ability, medications and how they’re working.
    • “He asks, too, about their use of tobacco, alcohol, cannabis and other nonprescription drugs. “Patients tend to not want to disclose this, but I put it in a health context,” Dr. Han said.
    • “He tells them, “As you get older, there are physiological changes and your brain becomes much more sensitive. Your tolerance goes down as your body changes. It can put you at risk.”
    • “That’s how he learns that someone complaining about insomnia might be using stimulants, possibly methamphetamines, to get going in the morning. Or that a patient who has long taken an opioid for chronic pain has run into trouble with an added prescription for, say, gabapentin. * * *
    • “Aging boomers “still use drugs far more than their parents did, and the field wasn’t ready for that.”
    • “Evidence of a growing problem has been stacking up. A study of opioid use disorder in people over 65 enrolled in traditional Medicare, for instance, showed a threefold increase in just five years — to 15.7 cases per 1,000 in 2018 from 4.6 cases per 1,000 in 2013.”
  • Fierce Healthcare informs us,
    • “Americans are likely to skip important health screenings, and women have a less positive outlook than men regarding their current and future health prospects, according to a survey released by Aflac.
    • “The survey, based on about 2,000 employed adults, examined attitudes, habits and opinions about health and preventive care and found that half of adults have avoided at least one common health screening. These screenings include tests for certain diseases.
    • “But for the 51% of respondents who said they have had cancer, that diagnosis came following a routine checkup or screening. For Hispanic survey respondents, 72% of individuals said a diagnosis was discovered at a routine checkup.
    • “Skipping regular checkups is common among individuals who feel healthy. One in 4 respondents said they miss routine checkups. Reasons cited include a conflict with work hours, the individuals are “not thinking about it,” a general dislike for going to the doctor’s office, insurance issues, fear of hearing bad news and the time commitment required.”
  • In the FEHBlog’s view, the best action for a health plan to take in response to these concerns is to connect members with in-network primary care providers.

From the Medicare front, Beckers Payer Issues points out that “Caps on Medicare prescription drug costs will save Part D enrollees a collective $7.4 billion in 2025, according to a report from HHS’ Office of the Assistant Secretary for Planning and Evaluation.  The report, published July 7, broke down expected savings from price caps by state. An estimated 18.7 million people, around 1 in 3 Medicare Part D enrollees, will save on drug costs in 2025. The average annual saving per person is estimated at $396.08.” That’s good news for FEHB and PSHBP plans with Part D EGWPs.

From the Rx coverage front, Fierce Healthcare notes

  • “On the heels of a similar announcement from Optum Rx, pharmacy benefit management giant Express Scripts said Monday that it will add three biosimilars to its formulary to compete with Humira.
  • “The PBM announced that it will include Boehringer Ingelheim’s Cyltezo and two biosimilars produced by Novartis’ Sandoz in its National Preferred Formulary. Humira, a drug for people with inflammatory conditions, is the top-selling pharmaceutical product in the world and has been viewed as a key target for savings thanks to biosimilar products.
  • “Express Scripts said its trend data show that anti-inflammatory drugs accounted for nearly 25% of total drug spending for its commercial business last year. An analysis from its parent company, Evernorth, found that increased biosimilar competition could save $225 billion to $375 billion over the next decade.”

Those savings will benefit FEHB and PSHBP plans.

From the employment front, the Society for Human Resource Management discusses steps that employers can take to support employees who have children with developmental disabilities.

STAT News and its readers offer 27 healthcare reads and podcasts for the beaches and mountains.

 

Weekend Update

David Ermer–Congress, Mental health care, U.S. Healthcare–
Mount Rushmore

From Washington, DC, both Houses of Congress return to work here this week for floor voting and Committee business. On Tuesday, July 11, 2023, the Senate Health, Education, Labor and Pensions Committee will hold a hearing titled “Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine.”

From the public health front, the Wall Street Journal reports

  • “The U.S. has spent decades eradicating lead from well-known sources such as paint, gasoline and pipes. The Journal’s investigation reveals a hidden source of contamination—more than 2,000 lead-covered cables—that hasn’t been addressed by the companies or environmental regulators. These relics of the old Bell System’s regional telephone network, and their impact on the environment, haven’t been previously reported.
  • “Lead levels in sediment and soil at more than four dozen locations tested by the Journal exceeded safety recommendations set by the U.S. Environmental Protection Agency. At the New Iberia fishing spot, lead leaching into the sediment near a cable in June 2022 measured 14.5 times the EPA threshold for areas where children play. “We’ve been fishing here since we were kids,” said Tyrin Jones, 27 years old, who grew up a few blocks away.
  • “For many years, telecom companies have known about the lead-covered cables and the potential risks of exposure to their workers, according to documents and interviews with former employees. They were also aware that lead was potentially leaching into the environment, but haven’t meaningfully acted on potential health risks to the surrounding communities or made efforts to monitor the cables.” * * *
  • “The Journal’s findings “suggest there is a significant problem from these buried lead cables everywhere, and it’s going to be everywhere, and you’re not even going to know where it is in a lot of places,” said Linda Birnbaum, a former EPA official and director of the National Institute of Environmental Health Sciences, a federal agency.”

Big ruh-roh.

From the health care cost front —

  • Health Payer Intelligence informs us
    • “What drivers influence the medical cost trend, and what steps can payers take to address these factors?
    • “The medical cost trend is the percentage that experts anticipate treatment costs will grow year-over-year, the PwC Health Research Institute’s (HRI) medical cost trend report for 2024 explains.
    • “The higher medical cost trend in 2024 reflects health plans’ modeling for inflationary unit cost impacts from their contracted healthcare providers, as well as persistent double-digit pharmacy trends driven by specialty drugs and the increasing use of the GLP-1 agonists for Type 2 Diabetes or weight loss,” the report summarized.
    • “In 2024, overall inflation, consolidation, pharmaceutical costs, and other factors will drive medical cost trend inflation, while biosimilars and site-of-care changes will exert deflationary force.”
  • Revcyle Intelligence points out
    • “Healthcare spending is still on the rise, with median costs per person increasing to over $6,000 in 2021, according to a new analysis from the Health Care Cost Institute (HCCI).
    • “Median per person healthcare spending increased by 24 percent from 2017 through 2021, HCCI’s latest Healthy Marketplace Index shows. But healthcare spending varied significantly depending on where people lived. For example, patients in metropolitan areas with the highest utilization rates paid nearly three times more for healthcare services that year compared to their neighbors in metropolitan areas with the lowest utilization rates.”
    • The American Medical Association (AMA) reports patients spent $433.2 billion, or 10.2 percent of total healthcare spending, in 2021, the same year of the HCCI analysis.
    • “High and growing health spending is forcing families, employers, and governments across the country to make difficult tradeoffs,” Katie Martin, HCCI’s president and CEO, said in a statement. “The Healthy Marketplace Index shows that health care costs depend a great deal on where you live, the result of market dynamics like prices, practice patterns, and competition. Therefore, we need a multi-dimensional approach to making [healthcare] more affordable.”
  • FEHBlog note — The AMA report indicates that health plan cost sharing for members is reasonable.
  • In related news, the Wall Street Journal warns us the “Last mile of the inflation flight will be the hardest; Housing and used-car sectors are expected to help push down the core index, but progress could then stall so long as the economy doesn’t weaken.”

From the medical research front, NPR offers a story about personal achievement

  • “Sixteen years ago, when Calliope Holingue was in high school, she had a problem. Two, actually. She developed gastrointestinal symptoms severe enough to force her to give up running, plus she had a long history of anxiety and obsessive-compulsive disorder. 
  • “And I wondered if maybe there was a link between my mental health and the GI symptoms I was experiencing,” she recalls now. 
  • “Her doctors shrugged off her questions. “That led me to start reading a lot about the gut microbiome, the autonomic nervous system, and their connection with the brain and mental health,” she says. 
  • “Today, Holingue [who holds a Ph.D degree in public health] has joined the ranks of scientists seeking to understand the interplay between the brain (and the rest of the nervous system) and the gut microbiome – that is the vast array of organisms, including bacteria, fungi and viruses, that thrive in the human gut. 
  • “She’s now an assistant professor of mental health at the Johns Hopkins School of Public Health and part of the faculty at the Center for Autism and Related Disorders at Kennedy Krieger Institute. She’s currently leading research on gut microbes and symptoms that cooccur with autism, including GI and behavioral symptoms.”

The article goes on to interview Dr. Holingue. The FEHBlog wishes her good luck.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity breaches and vulnerability front —

  • Cybersecurity Dive informed us on July 5,
    • “The widely exploited vulnerability in Progress Software’s MOVEit file transfer service has impacted nearly 200 organizations, according to Brett Callow, a threat analyst at Emsisoft.
    • “The scope of damage caused by Clop’s mass exploit of a zero-day vulnerability in MOVEit continues to snowball as third-party vendors expose multiple downstream victims. Progress discovered the zero-day over Memorial Day weekend on May 28.
    • “Despite the number of victims so far, experts anticipate more will come forward. “While many organizations have made a disclosure, a significant number have yet to do so,” Callow said via email.
    • “Progress on Wednesday released another update, including security fixes, and said it will consistently release MOVEit product updates every two months going forward.”
  • Here is a Cybersecurity and Infrastructure Security Agency (CISA) link about the Progress Software MOVEit patch.
  • CISA added another known exploited vulnerability yesterday.
  • On July 6, CISA issued a “Joint Cybersecurity Advisory on Newly Identified Truebot Malware Variants.”
    • “The Cybersecurity and Infrastructure Security Agency (CISA), Federal Bureau of Investigations (FBI), the Multi-State Information Sharing and Analysis Center (MS-ISAC), and the Canadian Centre for Cyber Security (CCCS) released a joint Cybersecurity Advisory (CSA), Increased Truebot Activity Infects U.S. and Canada Based Networks, to help organizations detect and protect against newly identified Truebot malware variants. Based on confirmation from open-source reporting and analytical findings of Truebot variants, the four organizations assess cyber threat actors leveraged the malware through phishing campaigns containing malicious redirect hyperlinks.
    • “Additionally, newer versions of Truebot malware allow malicious actors to gain initial access by exploiting a known vulnerability with the Netwrix Auditor application (CVE-2022-31199). As recently as May 2023, cyber threat actors used this common vulnerability and exposure to deliver new Truebot malware variants and to collect and exfiltrate information against organizations in the U.S. and Canada.
    • “CISA, FBI, MS-ISAC, and the CCCS encourage all organizations to review this joint advisory and implement the recommended mitigations contained therein—including applying patches to CVE-2022-31199, to reduce the likelihood and impact of Truebot activity, as well as other ransomware-related incidents.” 
  • Bleeping Computer reports
    • “CISA ordered federal agencies today to patch a high-severity Arm Mali GPU kernel driver privilege escalation flaw added to its list of actively exploited vulnerabilities and addressed with this month’s Android security updates.
    • “The flaw (tracked as CVE-2021-29256) is a use-after-free weakness that can let attackers escalate to root privileges or gain access to sensitive information on targeted Android devices by allowing improper operations on GPU memory.
    • “A non-privileged User can make improper operations on GPU memory to gain access to already freed memory and may be able to gain root privilege, and/or disclose information,” Arm’s advisory reads.”
  • and
    • “Security researchers have dissected a recently emerged ransomware strain named ‘Big Head’ that may be spreading through malvertising that promotes fake Windows updates and Microsoft Word installers.
    • “Two samples of the malware have been analyzed before by cybersecurity company Fortinet, who looked at the infection vector and how the malware executes.
    • “Today [July 8], Trend Micro published a technical report on Big Head that claiming that both variants and a third they sampled originate from a single operator who is likely experimenting with different approaches to optimize their attacks.”
  • Cybersecurity Dive points out
    • “More than two-thirds of Fortinet’s FortiGate firewalls remain at risk of exploits through a vulnerability the company disclosed on June 12, according to research Bishop Fox released Friday.
    • “Researchers at Bishop Fox, an offensive security testing firm, identified 490,000 affected SSL VPN interfaces exposed to the internet and determined 69%, around 338,000, of those FortiGate firewalls are unpatched.
    • “The heap-based overflow vulnerability, CVE-2023-27997, could allow a remote attacker to execute arbitrary code or commands and has a CVSS score of 9.8 out of 10.”
  • ISACA warns us
    • “In the US, the FBI and FCC recently warned that free USB charging stations in public spaces, such as airports, hotels, hospitals, business buildings and any other type of publicly available location, can have devices hidden within them to steal data, spread malware and commit other malicious activities broadly referenced as juice jacking. The term “juice jacking” started being used several years ago to mean that while individuals using USB charging ports to charge (or “juice”) their phones, they were also having their data highjacked (“jacked”) through malicious, unnoticed skimming tech. I actually started covering this risk at a few onsite security and privacy training courses in 2010 when I first became aware of what was then an emerging new threat from a business friend, an electrical engineer, who I think may have invented what the first juice jack blocker—a data blocker for USB ports was.
    • “The malicious USB charging connection not only gives access to the phone apps and data, but it creates a connection to all the networks that the phone is connected to that do not have active access controls and blocks established when the phone was connected to the USB charger. So, malicious USB charging ports, cables and possibly other components of the public charging stations can also be used to plant ransomware, keystroke loggers and other types of malware, GPS tracking and audio eavesdropping. They can also take control of the device being charged. All these malicious activities can occur not only on the device being charged (phone, laptop, tablet, etc.) but also on devices and network components within those other connected networks.”
  • The FEHBlog notes the ISACA article offers the following suggestions plus policy advice
    • “Juice jack blockers attach to the end of your USB cable to protect against skimmers when you charge your devices in public places. This is not as bulky as hauling around most portable chargers and extra cables. I’ve purchased USB juice jack blockers for as low as two for US$12. They’re small and easily fit in a pocket without any bulkiness.
    • “It’s also a good idea to travel with personal charging devices. While not as small as juice jack blockers, they have become much smaller, with much more power, and less expensive in recent years. They limit the need to use public chargers at all.
    • “Ideally, it would be best to make sure only non-data power-only ports and cables are used in public areas. However, most cables used to support data transfer, and there is not an easy way for most folks to visually tell if a cable is charge-only.”

From the cybersecurity defenses front —

  • Cybersecurity Dive discusses “the role for AI in cybersecurity; generative AI can be an ally for new security professionals. For more seasoned security analysts, it can offer time to refine their skills through automation of repetitive tasks.” Check it out.

Friday Factoids

David Ermer–ACA, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The White House kicked off its Friday with a bunch of new healthcare measures, none of which impact the FEHB. Roll Call offers a useful overview of the measures.
  • Here is a link to the related Affordable Care Act FAQ 60, which discusses the No Surprises Act measures, which are explained in the separate White House press release. To maintain one’s sanity, read the No Surprise Billing section of that press release before reading the FAQ. That will help you decide the relevance of the FAQ to your work.
  • In combing through the various press releases, the FEHBlog did run across this link to an HHS report to Congress on the No Surprises Act, which may be worth a gander.
    • “This first report focuses largely on establishing a baseline and a framework for further evaluation. The report details key trends in factors that will be important to evaluate NSA effects, including the implementation and impacts of state surprise billing laws already in effect; trends in market consolidation and concentration; the impact of market consolidation and concentration on prices, quality, and spending; and trends in OON billing. This report also describes a conceptual framework for considering the healthcare market effects of NSA, as well as describing potential methodologic approaches (and their limitations) for estimating these effects. Subsequent reports will implement these approaches.”
  • STAT News reports
    • “Medicare is planning to send $9 billion in lump-sum payments to more than 1,600 hospitals that participate in a drug discount program [known as 340B] after the Supreme Court found the program underpaid them for prescription drugs, the agency announced on Friday.
    • “To pay for the restitution, Medicare would slash all hospitals’ payments for other items and services by 0.5% for the next 16 years.”
    • The FEHBlog paraphrases the Bible, “First it giveth, then it taketh away.”
  • The Society for Human Resource Management tells us
    • “The U.S. Equal Employment Opportunity Commission (EEOC) has postponed the deadline for employers to file their 2022 EEO-1 reports, which list workforce demographic data, including race and sex.
    • “An announcement on the EEOC’s website explained: “The EEOC is currently completing a mandatory, three-year renewal of the EEO-1 Component 1 data collection by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). Accordingly, the EEOC has updated the tentative opening of the 2022 EEO-1 Component 1 data collection to the Fall of 2023.”
    • “A more precise date was not available. Previously, the tentative deadline for filing was in mid-July.”

Let’s wrap us this Friday with potpourri:

  • Politico interviews the income president of the American Medical Association Jesse Ehrenfeld, MD.
  • Benefits Pro discusses Rx optimization programs.
  • Health IT Analytics explains “How Elevance Health and MVP Health Care are leveraging data analytics. The two payers share how they leverage data analytics, predictive modeling, and data quality frameworks to improve outcomes for members.”
  • MedPage Today points out
    • “As research interest in the therapeutic potential of psychedelics has grown — with academic centers popping up across the country, and compounds already in developmen — the FDA recently caught up, issuing a draft guidance on managing clinical trials of these drugs.
    • “The draft guidance was released on June 23, as one of the largest U.S. psychedelic conferences was underway. It outlined the agency’s views on best practices in clinical trial design for psychedelic drugs — including psilocybin, lysergic acid diethylamide (LSD), and methylenedioxymethamphetamine (MDMA) — in the treatment of medical conditions, including psychiatric or substance use disorders.
    • “In an email to MedPage Today, an FDA spokesperson called psychedelics “a very active and challenging area of drug development.”
    • “As an emerging area of drug development, there is limited experience as to the configuration of programs that may support approval of a psychedelic drug,” the spokesperson wrote. “The guidance presents foundational constructs that all sponsors, including academic sponsor-investigators, studying the therapeutic potential of psychedelic drugs should consider.”
  • The Wall Street Journal questions whether people should be judgmental about other people who lose weight with the new generation of weight loss drugs.
    • “Elizabeth Owen didn’t let her husband’s comments dissuade her from taking Ozempic. (John Owen, 60, who had recommended his wife continue to exercise and eat healthy to lose the weight, says he was just telling her to do what he would have done in her situation.) At 5’2” and 142 pounds, she was the heaviest she had ever been, despite regular workouts with a personal trainer.
    • “Owen, who lives in Orlando, Fla., says she has been embarrassed to tell her personal trainer about taking Ozempic. She did tell a good friend, who told her the drug would make her sick.
    • “She has lost 34 pounds so far and takes a small maintenance dose. Recently, John’s doctor advised him to lose weight and prescribed Wegovy, which he’s taking. 
    • “Friends and family also are starting to ask about her treatment in a more positive way, she says. 
    • “They’re curious because I’m maintaining the weight loss,” she says. “A year later, they all want to know why.”

Thursday Miscellany

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

From Washington, DC —

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

From the public health front —

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

From the telehealth and artificial intelligence fronts, we learn from

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

From the U.S. healthcare business front

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

 

Midweek Update

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

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

From Washington, DC —

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

From the public health front —

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

From the Rx and medical devices coverage front —

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

From the U.S. healthcare business front

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

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

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

Monday Roundup

David Ermer–CMS, Congress, FDA, Federal employment benefits, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • The House of Representatives and the Senate remain on a District / State work break until next week. Of course, tomorrow is a federal holiday even for Congress as our Nation celebrates its 247th birthday.
  • Roll Call reports that the House Republican leadership is already
    • “discussing the possibility of putting a stopgap spending bill on the floor as soon as this month as a fail-safe option while they try to build support for passing fiscal 2024 appropriations bills that appear on shaky ground.
    • “The idea, according to one person familiar with the conversations, is to have a stopgap in place to continue government funding past Sept. 30 in the event all the regular appropriations bills are not passed by the end of the fiscal year. That move would avoid a partial government shutdown in October if the Senate also passed the stopgap and President Joe Biden signed it into law.”
  • The Food and Drug Administration (FDA) is expected to decide this week whether or not to accept its advisory committee’s recent unanimous decision to give full marketing approval to Eisai / Biogen’s Leqembi. If that approval is given, the Centers for Medicare and Medicaid Services plans to provide Medicare Part B coverage for the drug based on the following prerequisites identified by Pharmacy Practice News
    • “To receive benefits for lecanemab-irmb [marketed as Leqembi], a Medicare patient must be:
    • “1. enrolled in Medicare Part B;
    • “2. diagnosed with mild cognitive impairment or early dementia caused by Alzheimber’s Disease;
    • “3. have an appropriate clinical team and follow-up care;
    • “4. meet any label requirements the FDA specifies; and
    • “5. be attended by a qualified physician participating in a registry that collects evidence about the drug’s performance.
  • “CMS will offer a nationally available online portal where clinicians can submit data via an “easy-to-use” format, the agency said. This kind of registry, which has been used after regular approval of other drugs, is critical for researchers to better understand the benefits and risks of this new class of drugs.”
  • The intravenously delivered drugs is retail priced at $26,500 annually.
  • The Washington Post and NPR offer lengthy articles on this development that are worth reading.
    • From NPR:
    • “The first drug shown to slow down Alzheimer’s disease is likely to receive full approval from the Food and Drug Administration by July 6.
    • “In theory, the move would make lecanemab (Leqembi) available to more than a million Medicare patients in the early stages of Alzheimer’s. In practice, though, the number is likely to be much smaller.
    • “I’d be surprised if right away we saw demand from that many people,” saysDr. David Rind, chief medical officer of the Institute for Clinical and Economic Review. The number could be in the hundreds of thousands, though, he says.
    • “Lecanemab’s rollout could be slowed by factors ranging from the extra paperwork required of doctors to a shortage of medical personnel trained to diagnose and treat patients, experts say.”
  • MedPage Today emphasizes the importance of cognitive assessments in the rollout of this new drug.
    • “Clinical trials show that lecanemab can be highly effective in clearing the brain of amyloids, the plaque-like substance closely associated with Alzheimer’s. Physicians must confirm the presence of amyloid beta pathology before starting treatment.
    • “Reducing amyloids in individuals who have advanced symptoms, however, is pointless. The amyloids need to be cleared before they can ravage the brain, which puts greater emphasis on cognitive screening to find individuals most at risk.”
  • In related news, Medscape tells us
    • “Roche has received US Food and Drug Administration (FDA) 510(k) clearance for additional cerebrospinal fluid (CSF) assays for Alzheimer’s disease (AD), supporting timely diagnosis and treatment decision-making.
    • “The Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys total-tau CSF assays (tTau) (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for AD.
    • “They join the Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022, as reported previously by Medscape Medical News.
    • “An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.
    • “Appropriate use recommendations for new and emerging AD drugs call for confirmation of amyloid pathology. Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.”

In other FDA news,

  • Medscape informs us
    • “The US Food and Drug Administration (FDA) has approved Suflave, a new low-volume, lemon-lime flavored liquid osmotic laxative for colonoscopy preparation in adults, the manufacturer, Sebela Pharmaceuticals, has announced.
    • “Suflave comes in a carton containing two bottles and two flavor packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride. One bottle and one flavor packet are equivalent to one dose.
    • “Administration of both doses is required for complete preparation for colonoscopy. After each dose, an additional 16 ounces of water must be consumed. 
    • “In a clinical trial, 94% of patients achieved successful bowel cleansing with Suflave, the company said in a news release. 

In Rx coverage news —

  • Reuters brings us up to date on the Humira biosimilars that charged out of the starting gate on July 1.

In public health news —

  • HHS’s Health Resources and Services Administration published in the Federal Register
    • “the first of two notices planned for the coming months informing the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs). This notice includes the lists of HPSAs in a designated status as of April 28, 2023. The lists are available on the shortage area topic page on HRSA’s data.hrsa.gov website * * *.”
  • The Journal of the American Medical Association published an original investigative report on “Trends in State-Level Maternal Mortality by Racial and Ethnic Group in the United States.”

From the mental health front, NPR offers a step-by-step guide to finding a therapist “taking both your mental health needs and your budget into account.”

From the federal employee benefits front,

  • FedWeek shares last-minute checks for federal and postal annuitants.
    • “Are you enrolled in the Federal Employee Health Benefits (FEHB)program? Most employees are. If you are one of them and are planning to retire, you need to be aware of the 5-year rule. To carry your FEHB coverage into retirement, you must have been enrolled in the program for 5 consecutive years before you retire or from your first opportunity to enroll (note: there is an exception for those retiring with an early retirement offer). If you meet the requirement, your coverage will continue, and your premiums will be the same as they were when you were an employee.
    • “If you retire but haven’t met that retirement, you’ll be given 31 days of coverage at no cost to you. After that, you’ll have the option of continuing in that plan (or another plan of your choice) under the Temporary Continuation of Coverage (TCC) provision for up to 18 months. If you choose to do that, you’ll pay 100 percent of the premiums plus 2 percent to cover the administration cost incurred by your agency. When that coverage ends, you’ll need to make other arrangements for your health insurance.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front

  • Cybersecurity Dive reports
    • “The White House outlined its cybersecurity budget priorities for fiscal year 2025 in a memorandum sent to executive departments and agencies Tuesday.
    • “The Biden administration is looking to connect cybersecurity investments to the five pillars of the national cybersecurity strategy it released in early March, the document shows.
    • “The letter, signed by Acting National Cyber Director Kemba Walden and Office of Management and Budget Director Shalanda Young, advises federal agencies to prioritize spending on critical infrastructure defense, disrupting and dismantling threat actors, software that is secure by design, resiliency and international partnerships. * * *
    • “Agencies that bear responsibility for disrupting ransomware are advised to submit budgets that prioritize staff resources to investigate ransomware, disrupt ransomware infrastructure and participate in interagency task forces focused on cybercrime.”
  • The Government Accountability Office issued a report on launching and implementing the national cybersecurity strategy.
    • “Federal agency information systems and national critical infrastructure are vulnerable to cyberattacks.
    • “This Snapshot covers the status of the National Cybersecurity Strategy. The strategy’s goals and strategic objectives provide a good foundation, but the Administration needs to establish specific objectives and performance measures, resource requirements, and roles and responsibilities.
    • “It will be difficult to implement the strategy when the specific details have yet to be issued. The continued vacancy in the role of National Cyber Director is also a challenge.”

From the cybersecurity vulnerabilities and breaches front —

  • Health IT Security breaks down the breach reports submitted to the HHS portal in the first six months of 2023.
    • “HealthITSecurity has compiled a list of the top ten biggest healthcare data breaches reported to the HHS Office for Civil Rights (OCR) data breach portal this year as of late June 2023, based on the number of individuals impacted for each event. It is important to note that this list refers to breaches reported to OCR in 2023, but a few occurred in 2022 or earlier.
    • “Some of the biggest breaches so far this year stemmed from known cybersecurity vulnerabilities in Fortra’s GoAnywhere managed file transfer (MFT) solution and attacks on other third-party vendors, while others involved direct cyberattacks against healthcare organizations.”
  • Cybersecurity Dive tells us
    • “Fallout from Clop’s mass exploit of a zero-day vulnerability in Progress Software’s MOVEit file transfer service continues to ensnare additional victims. The prolific ransomware actor is listing new compromised systems on its leak site daily and some organizations are still disclosing breaches.
    • “At least 108 organizations, including seven U.S. universities, have been listed by Clop or disclosed as having been impacted thus far, according to Brett Callow, threat analyst at Emsisoft.
    • “The University of California, Los Angeles, is the latest organization to disclose a breach of its MOVEit platform. The school’s IT security team discovered malicious activity on June 1, a spokesperson told Cybersecurity Dive. * * *
    • “Organizations are disclosing breaches weeks after Progress first acknowledged the MOVEit vulnerability and cybersecurity experts warned about mass exploits. Two additional vulnerabilities in the file-transfer service have subsequently been discovered. * * *
    • “Some organizations have been impacted due to their direct use of MOVEit while others have been exposed as a result of third-party vendors’ use of the file transfer service, including PBI Research Services and Zellis.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) informs us
    • “The Homeland Security Systems Engineering and Development Institute, sponsored by the Department of Homeland Security and operated by MITRE, has released the 2023 Common Weakness Enumeration (CWE) Top 25 Most Dangerous Software Weaknesses. The CWE Top 25 is calculated by analyzing public vulnerability data in the National Vulnerability Data (NVD) for root cause mappings to CWE weaknesses for the previous two calendar years. These weaknesses lead to serious vulnerabilities in software. An attacker can often exploit these vulnerabilities to take control of an affected system, steal data, or prevent applications from working. 
    • “The 2023 CWE Top 25 also incorporates updated weakness data for recent CVE records in the dataset that are part of CISA’s Known Exploited Vulnerabilities Catalog (KEV). 
    • “CISA encourages developers and product security response teams to review the CWE Top 25 and evaluate recommended mitigations to determine those most suitable to adopt. Over the coming weeks, the CWE program will be publishing a series of further articles on the CWE Top 25 methodology, vulnerability mapping trends, and other useful information that help illustrate how vulnerability management plays an important role in Shifting the Balance of Cybersecurity Risk.”
  • On June 29, 2023, CISA added eight known exploited vulnerabilities to its Catalog.
  • The Cybersecurity and Infrastructure Security Agency advises us
    • “CISA is aware of open-source reporting of targeted denial-of-service (DoS) and distributed denial-of-service (DDoS) attacks against multiple organizations in multiple sectors. These attacks can cost an organization time and money and may impose reputational costs while resources and services are inaccessible.
    • “If you think you or your business is experiencing a DoS or DDoS attack, it is important to contact the appropriate technical professionals for assistance.
    • “Contact your network administrator to confirm whether the service outage is due to maintenance or an in-house network issue. Network administrators can also monitor network traffic to confirm the presence of an attack, identify the source, and mitigate the situation by applying firewall rules and possibly rerouting traffic through a DoS protection service.
    • “Contact your internet service provider to ask if there is an outage on their end or if their network is the target of an attack and you are an indirect victim. They may be able to advise you on an appropriate course of action.
    • “Organizations can take proactive steps to reduce the effects of an attack—See the following guidance for more information:

From the ransomware front, here is a link to Bleeping Computer’s the Week in Ransomware.

From the cybersecurity defenses front —

  • Venture Beat reports
    • “Forrester’s recent report, The State of Cloud in Healthcare, 2023, provides an insightful look at how healthcare providers are fast-tracking their cloud adoption with the hope of getting cybersecurity under control. Eighty-eight percent of global healthcare decision-makers have adopted public cloud platforms, and 59% are adopting Kuber netesto ensure higher availability for their core enterprise systems. On average, healthcare providers spend $9.5 million annually across all public cloud platforms they’ve integrated into their tech stacks. It’s proving effective — to a point.
    • “What’s needed is for healthcare providers to double down on zero trust, first going all-in on identity access management (IAM) and endpoint security. The most insightful part of the Forrester report is the evidence it provides that continuing developments from Amazon Web Services, Google Cloud Platform, Microsoft Azure and IBM Cloud are hitting the mark with healthcare providers. Their combined efforts to prove cloud platforms are more secure than legacy network servers are resonating.”
  • CISA released cloud services guidance and resources.
  • Cybersecurity Dive points out that “Long before a data breach, well-prepared companies set up incident response teams with workers from multiple departments.”