FEHBlog

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Per Cybersecurity Dive,
    • “The Biden administration outlined a comprehensive plan Tuesday [June 4] to harmonize a bevy of federal, state and international regulations designed to boost cyber resilience among the nation’s private sector and critical infrastructure providers. Industry stakeholders want the administration to simplify the reporting process to cut back on duplicative disclosure requirements. 
    • “National Cyber Director Harry Coker Jr. said the administration is working on a pilot reciprocity framework to determine how best to streamline the administrative load on critical infrastructure subsectors, in a Tuesday blog post. 
    • “The administration will also seek additional help from Congress to find legislative authorities to reduce administrative redundancies.
  • The Senate Homeland Security and Governmental Affairs Committee held a hearing on this topic on June 5.
    • “During the hearing, Peters and the witnesses emphasized the importance of having standardized regulations across critical infrastructure sectors to ensure our nation is best prepared to respond to cybersecurity threats. They also reinforced that cybersecurity remains one of the most pressing challenges facing our nation due to our reliance on interconnected systems and increasingly complex cyberattacks. “During the hearing, Peters and the witnesses emphasized the importance of having standardized regulations across critical infrastructure sectors to ensure our nation is best prepared to respond to cybersecurity threats. They also reinforced that cybersecurity remains one of the most pressing challenges facing our nation due to our reliance on interconnected systems and increasingly complex cyberattacks. 
    • “Nicholas Leiserson, Assistant National Cyber Director for Cyber Policy and Programs for the Office of the National Cyber Director (ONCD) – the lead federal agency for harmonizing cybersecurity regulations – discussed the challenges the office faces when trying to promote harmonization. David Hinchman, Director of Information Technology and Cybersecurity at the Government Accountability Office, discussed how regulators can best tailor cybersecurity requirements to promote a cohesive response to protect themselves and critical infrastructure owners and operators from cyberattacks.”  
  • Cyberscoop reports on the hearing and a related CISA action.
  • Cybersecurity Dive adds,
    • “Sen. Ron Wyden, D-Ore., is urging the HHS to require large healthcare organizations to improve their cybersecurity practices as increasing attacks and data breaches rock the industry. “Sen. Ron Wyden, D-Ore., is urging the HHS to require large healthcare organizations to improve their cybersecurity practices as increasing attacks and data breaches rock the industry. 
    • “In a letter to Secretary Xavier Becerra, the chairman of the Senate Committee on Finance said the agency’s approach to regulating healthcare cybersecurity is “woefully inadequate,” leaving the sector vulnerable to attack.” 

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive (June 6) and HHS’s Health Sector Cybersecurity Coordination Center (HC3) (June 7) discuss vulnerabilities to Snowflake’s cloud platform.
    • On June 02, 2024, Snowflake observed an increase in cyber threats targeting accounts on their cloud data platform. The vulnerability is possibly associated with CVE-2023-51662. HC3 strongly encourages all users to review the following advisory, and to apply any mitigations to prevent serious damage from occurring to the Healthcare and Public Health (HPH) sector.
  • Dark Reading informs us,
    • “SolarWinds has released its version 2024.2, including a variety of new features and upgrades, along with patches for three different security vulnerabilities.
    • “Notably, one high-severity SWQL injection bug, tracked under CVE-2024-28996 (CVSS 7.5), was reported to SolarWinds security by Nils Putnins, a penetration tester affiliated with the North Atlantic Treaty Organization (NATO), the company reported along with the new release. The other flaws fixed in the latest SolarWinds update included a high-severity cross-site scripting flaw, tracked under CVE-2024-29004 (CVSS 7.1), and a medium-severity race condition vulnerability affecting the Web console, tracked under CVE-2024-28999 (CVSS 7.1), the company said.”
  • HC3 issued on June 4 threat guidance concerning Baxter Welch Allyn vulnerabilities. Baxter Welch Allen manufactures medical devices.

From the ransomware front,

  • Per Cybersecurity Dive,
    • “Ransomware activity surged last year as attackers flocked to legitimate remote access tools to break into enterprise networks, Mandiant said in a Monday [June 3] report. “Ransomware activity surged last year as attackers flocked to legitimate remote access tools to break into enterprise networks, Mandiant said in a Monday [June 3] report.
    • “There were 4,520 posts on data leak sites last year, a 75% increase from 2022. Threat groups use data leak sites to make claims and ramp up pressure on alleged victims. The number of posts surged to more than 1,300 in the third quarter, setting a quarterly record, Mandiant said. The firm tracked more than 1,200 data leak site posts in the second quarter.
    • “In 2023, Mandiant led 20% more investigations involving ransomware than the previous year, underscoring further evidence of a swell in attacks. “The slight dip in extortion activity in 2022 was an anomaly,” the incident response and research firm said.”
  • Per Fierce Healthcare, “Ascension targets June 14 for system-wide EHR restoration after ransomware attack.”
  • Statescoop lets us know,
    • “Victims of ransomware attacks by the Russian ransomware group LockBit can now unlock their encrypted data for free using the 7,000 decryption keys obtained by the FBI, a federal official announced during an event in Boston on Wednesday [June 4]. “Victims of ransomware attacks by the Russian ransomware group LockBit can now unlock their encrypted data for free using the 7,000 decryption keys obtained by the FBI, a federal official announced during an event in Boston on Wednesday.
    • “The announcement comes after law enforcement took down the group’s infrastructure in February through “Operation Cronos,” an international operation designed to disrupt LockBit’s business model and expose members of the ransomware gang, FBI Cyber Division Assistant Director Bryan Vorndran said in a keynote Wednesday at the 2024 Boston Conference on Cyber Security.
    • “Though the gang still operates, reports show the mission disrupted its activities.
    • “From our ongoing disruption of LockBit, we now have over 7,000 decryption keys and can help victims reclaim their data and get back online,” Vorndran said.”

From the cybersecurity defenses front,

  • Cybersecurity Dive tells us
    • “Telecommunications, media and technology companies are outperforming other sectors in cybersecurity, with more advanced defenses and cyber governance models, Moody’s said Thursday in a report on the sector.” Telecommunications, media and technology companies are outperforming other sectors in cybersecurity, with more advanced defenses and cyber governance models, Moody’s said Thursday in a report on the sector.
    • “Companies in these sectors accelerated cybersecurity spending by more than 125% on average during the last five years, compared to a 100% growth rate over that period for all global companies, according to the report. Technology companies doubled their cybersecurity spending over the five-year period while telecom businesses increased spending by more than 250%. 
    • “Cybersecurity spending nearly doubled during the past five years, accounting for 10% of companies’ technology budgets in 2023, according to Moody’s. The report is based on Moody’s research and a survey of more than 1,700 respondents.”
  • Here’s a link to Dark Reading’s CISO corner.

Friday Factoids

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thursday Miscellany

David Ermer–Congress, FDA, HSA, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Following up on the House Appropriations subcommittee’s approval of the Financial Services and General Government bill yesterday, Fedweek notes,
    • “By taking no position on a raise, the measure effectively endorses President Biden’s proposal for a 2 percent increase in January. That would follow the practice of most recent years of allowing the recommendation to take effect by default, and would result in the smallest raise since the 1 percent paid in January 2021. The measure however does continue longstanding language tying raises for wage grade employees to those of GS employees in an area, even though the two pay systems operate under separate locality-based rules.”
  • The Washington Post reports “Biden wants hospitals to report data on gunshot wounds.”
    • “The Biden administration is enlisting America’s doctors to help combat gun violence.
    • “About 160 health-care executives and officials have been invited to the White House today and Friday to promote public health solutions to the epidemic. A top priority, I’m told: The White House wants hospital emergency departments to collect more data about gunshot injuries their physicians treat, as well as routinely counsel patients about the safe use of firearms.”
  • Healthcare Dive informs us,
    • “A federal judge ruled Wednesday Novant Health can move forward with its plans to purchase two North Carolina hospitals from Community Health Systems, despite a request from the Federal Trade Commission to stall the deal.”A federal judge ruled Wednesday Novant Health can move forward with its plans to purchase two North Carolina hospitals from Community Health Systems, despite a request from the Federal Trade Commission to stall the deal.
    • “The antitrust agency sued to block the deal in January, claiming it would decrease competition and drive up consumer prices in the greater Lake Norman, North Carolina, area by allotting Novant more than 65% control of the region’s inpatient market.
    • “U.S. district judge Kenneth Bell denied the FTC’s request for an injunction, saying the hospitals are likely to shutter absent a deal.”
  • On a related note, the Wall Street Journal continues its series on hospital consolidation.

From the public health and medical research front,

  • The Washington Post reports
    • “A 59-year-old male resident of Mexico died after being infected with a bird flu subtype never before confirmed to have spread to humans, the World Health Organization said Wednesday.”
    • “The man, who suffered from other underlying health conditions, had no known exposure to poultry or other animals before being formally diagnosed by a laboratory with the H5N2 subtype of avian flu. The case marks the first time a human has been confirmed to be infected with this subtype, and the first time an avian H5 virus was confirmed in a person in Mexico.
    • “Due to the constantly evolving nature of influenza viruses, WHO continues to stress the importance of global surveillance,” WHO said in a statement. “This case does not change the current WHO recommendations on public health measures and surveillance of influenza,” it added, rating current risks to the general population as “low.”
  • and
    • “‘Unusual’ cancers emerged after the pandemic. Doctors ask if covid is to blame.”‘Unusual’ cancers emerged after the pandemic. Doctors ask if covid is to blame.
    • “It’s not a new idea that viruses can cause or accelerate cancer. But it will probably be years before answers emerge about covid and cancer.”
  • Mercer Consulting offers bird flu considerations for employers.
  • The NIH Director in her blog relates,
    • “The ability to communicate using only your thoughts might sound like the stuff of science fiction. But for people who don’t have the ability to speak or move due to injury or disease, there’s great hope that this may one day be possible using brain-computer interfaces (BCIs) that can “read” relevant brain signals and translate them into written or spoken words. A research team has made a preliminary advance in this direction by showing for the first time that a computerized brain implant can decode internal speech with minimal training.
    • “In the new NIH-supported study, researchers implanted such a device in a brain area known to be important for representing spoken words called the supramarginal gyrus in two people with tetraplegia, a condition marked by full body paralysis from the neck down due to cervical spinal cord injury. The researchers found that the device could decode several words the participants “spoke” only in their minds. While we are far from using such a device to decode whole sentences or even phrases, and the exact mechanisms of internal speech are still under study, the findings, reported in Nature Human Behavior , are notable because it had been unclear whether the brain signals involved in thinking words could be reproducibly translated. * * *
    • “While there is much more to learn about how to decode internal speech more reliably across individuals, the findings offer proof-of-concept for a high-performance internal speech BCI. The new research adds to a growing portfolio of rapidly advancing technologies supported by the BRAIN Initiative that could one day routinely restore the ability to communicate for those who can no longer speak or even move, including people with brain injuries, paralysis, or diseases such as amyotrophic lateral sclerosis (ALS).”
  • Per BioPharma Dive,
    • “Expert advisers to the Food and Drug Administration will need to weigh whether Eli Lilly’s experimental Alzheimer’s disease drug donanemab is widely effective or should be restricted only to people who have deposits in their brains of a toxic protein called tau, according to documents released Thursday ahead of a key regulatory meeting next week.
    • “The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well as on the risks of mild brain swelling that can result from donanemab and other drugs of its type.”The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well as on the risks of mild brain swelling that can result from donanemab and other drugs of its type.
    • “If approved, donanemab would be the third amyloid-targeted drug to launch. Biogen has withdrawn the first, called Aduhelm, after much controversy and few sales. Eisai, along with Biogen, more recently won approval of a second, called Leqembi, which brought in sales of $19 million in the first quarter.”

From the U.S. healthcare business front,

  • Health Affairs offers advice to employers about how to help employees reduce their healthcare costs.
    • “Employers, and especially small employers, may have limited ability to affect the direct causes of increasing spending—notably high prices. However, they do have some options that could lower the burden of out-of-pocket costs for their employees. Employers could partner with insurers to use more innovative cost-sharing structures in the health insurance benefits offered to their employees. In addition, they could increase the use of benefit designs that distribute costs more equitably, which may improve affordability for low- to middle-income workers.”
  • HR Dive tells us,
    • “In an era when retirement is frequently at the forefront of ageism, diversity and benefits conversations, older adults now make up a larger share of American workforce members over the age of 55. The Employee Benefit Research Institute found that adults aged 65 and older made up 29.5% of the workforce in 2023, compared to an estimated 23% in 2000.
    • “Additionally, EBRI noted that the share of Hispanic workers aged 55 and older more than doubled, with the share of older White workers dropping from about 87% to 81%.
    • “The changing demographic characteristics of the older workforce are “important considerations for employers to understand, as older workers and a more diverse work force calls for additional or new answers to the optimal design of employee benefit plans,” Craig Copeland, director of wealth benefits at EBRI, said in a release.”
  • EBRI also released a Fast Facts publication informing us that “HSAs Reduce Use of Outpatient Services and Prescription Drugs, Increase Use of Inpatient Services; Overall Spending Unaffected.”

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.”

 

Monday Roundup

David Ermer–Generative AI, NIH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The FEHBlog travelled back to DC yesterday,
  • Per a Department of Health and Human Services press release,
    • “Today, the U.S. Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced a combined investment of $15 million over four years through the Rural Maternity and Obstetrics Management Strategies (Rural MOMS) Program to improve maternal health in rural communities and a new program focused on strengthening maternal care and reducing disparities in the Delta region (within Alabama, Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri, and Tennessee). HRSA Deputy Administrator Jordan Grossman highlighted these strategic investments today in Flagstaff, AZ, during the third state convening of HRSA’s Enhancing Maternal Health Initiative.”
  • The NIH Director in her blog tells us,
    • The NIH Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative has expanded scientists’ understanding of the human brain in recent years, offering fascinating insights into the ways that individual cells and complex neural circuits interact dynamically to enable us to think, feel, and act. But neuroscientists still have much more to learn about how our brains are put together at the most fundamental, subcellular level.  
    • As a step in that direction, in a new study supported in part by the NIH BRAIN Initiative and reported in the journal Science , researchers have created the most detailed nanoscale resolution map ever produced of a cubic millimeter of brain tissue, about the size of half a grain of rice. * * *
    • While there is plenty still left to uncover, the findings offer proof-of-principle that it’s possible to visualize the brain at this very detailed level. This is crucial groundwork for new research now supported by the BRAIN Initiative Connectivity Across Scales (BRAIN CONNECTS) program. BRAIN CONNECTS will develop and scale up tools to produce an equally detailed map of a complete mouse brain, which is about 1,000 times larger than the human brain fragment. The researchers now hope their 3D map and others like it will be put to work to understand both normal and disordered brain function more fully.

From the public health and medical research front,

  • The AMA News lets us know what doctors wish their patients knew about the measles.
  • NIH announced.
    • “In a proof-of-concept study, researchers at the National Institutes of Health (NIH) have developed an artificial intelligence (AI) tool that uses routine clinical data, such as that from a simple blood test, to predict whether someone’s cancer will respond to immune checkpoint inhibitors, a type of immunotherapy drug that helps immune cells kill cancer cells. The machine-learning model may help doctors determine if immunotherapy drugs are effective for treating a patient’s cancer. The study, published June 3, 2024, in Nature Cancer, was led by researchers at the National Cancer Institute’s (NCI) Center for Cancer Research and Memorial Sloan Kettering Cancer Center in New York. NCI is part of the National Institutes of Health. * * *
    • “The researchers noted that larger prospective studies are needed to further evaluate the AI model in clinical settings. They have made their AI model, called Logistic Regression-Based Immunotherapy-Response Score (LORIS), publicly available at https://loris.ccr.cancer.gov. The tool estimates the likelihood of a patient responding to immune checkpoint inhibitors based on data on the six variables described above.”
  • Health Day tells us,
    • “About one in eight U.S. seniors will be treated for a traumatic brain injury, typically during a fall, a new study finds.” About one in eight U.S. seniors will be treated for a traumatic brain injury, typically during a fall, a new study finds.
    • “Medicare data shows that about 13% of seniors suffered a severe concussion during an average follow-up period of 18 years, researchers report.
    • “Although these injuries can be treated, they increase the risk of serious conditions like dementia, Parkinson’s disease, seizures, heart disease, depression and anxiety, they added.
    • “The number of people 65 and older with TBI is shockingly high,” said senior researcher Dr. Raquel Gardner, a neurologist with the Sheba Medical Center in Israel.”
  • Healio points out,
    • “Statin therapy was tied to a 5-year CVD risk reduction in adults aged 75 years and older.”Statin therapy was tied to a 5-year CVD risk reduction in adults aged 75 years and older.
    • “Statin use did not increase the risk for major adverse events, such as liver dysfunction.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nonprofit hospital margins hit 4.3% in April, up 33% year over year, according to Kaufman Hall’s “National Hospital Flash Report” released June 3.”Nonprofit hospital margins hit 4.3% in April, up 33% year over year, according to Kaufman Hall’s “National Hospital Flash Report” released June 3.
    • “Kaufman Hall examined data from 1,300 hospitals in Syntellis Performance Solutions’ database and found that while hospital margins are improving overall, so is the gap between the highest and lowest performing hospitals. The best performing hospitals had a margin of 28.9%, compared to -16.1% for the worst performing hospitals. * * *
    • “Of note, the data revealed:
      • “1. Outpatient revenue increased 10% year over year in April.
      • “2. Average length of stay dropped 4% year over year in April.
      • “3. Emergency department visits increased to hit pre-pandemic levels.”
  • BioPharma Dive informs us,
    • “An experimental GLP-1 pill helped people with obesity lose significantly more weight than a placebo over three months, according to summary results revealed by developer Structure Therapeutics Monday.
    • “Structure’s drug led to an average reduction in body weight of 6.2% over placebo. One-third of those on the drug, dubbed GSBR-1290, lost 10% or more of their body weight, compared to zero of those given placebo.”
  • Per MedTech Dive,
    • “BD has agreed to buy Edward Lifesciences’ critical care group for $4.2 billion in cash, ending Edwards’ plan to spin off the business.
    • “In a Monday announcement, BD highlighted the group’s patient monitoring technologies and artificial intelligence-enabled clinical decision products that will add to BD’s existing businesses. Edwards’ critical care unit grew revenue by 8.5% year over year to $928.1 million in 2023.
    • “RBC Capital Markets analyst Shagun Singh said the deal would streamline Edwards. “Notably, the transaction creates a pure-play structural heart company positioning them for strategic initiatives that could further create shareholder value,” Singh wrote in a note to investors.”

Weekend Update

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

From Washington, DC

  • Forbes columnist Avik Roy writes about good and bar Congressional efforts to control drug pricing.

From the American Society of Clinical Oncology (ASCO) conference currently being held in Chicago,

  • STAT News reports
    • “In patients with stage 3 lung cancer where a particular genetic mutation is present in the tumor, taking AstraZeneca’s cancer-fighting pill Tagrisso reduced the chance that disease would progress by 84%.
    • “This will be practice changing as soon as this becomes available,” said David R. Spigel, chief scientific officer of the Sarah Cannon Research Institute at a press conference announcing the results at the annual meeting of the American Society of Clinical Oncology. “This will be how patients are treated wherever they can get access to this drug.”
  • and
    • The cancer drug Enhertu stalled the growth of tumors by more than a year, significantly longer than standard chemotherapy did in women with the most common form of metastatic breast cancer — a clinical trial result that once again promises to rewrite the rules for the treatment of the disease.
    • The makers of Enhertu, Daiichi Sankyo and AstraZeneca, said the new data, if cleared by regulators, could shift the way physicians treat hormone receptor-positive, metastatic breast cancer, and create a new standard of care in which patients with breast tumors that express even the faintest amount of HER2 protein can benefit.
    • “It’s not an overestimation to say that trastuzumab deruxtecan is the most potent drug ever developed for breast cancer,” said Paolo Tarantino, a medical oncologist at the Dana-Farber Cancer Institute, using the scientific name for Enhertu. “It does come with side effects that we’re learning to manage, but with that said, I’ve never seen data like what’s being reported here.”
    • The results, from a Phase 3 study called Destiny-Breast06, were presented Sunday at the annual meeting of the American Society of Clinical Oncology.
  • and
    • Comfort can be delivered to patients with advanced cancer virtually just as well as in person, according to a new study presented on Sunday at the American Society of Clinical Oncology annual meeting in Chicago.
    • That’s welcome news to palliative care experts who have, in many cases, preferred the convenience and efficacy of telehealth sessions for both themselves and their patients since the Covid-19 pandemic forced virtual visits.

In other public health and medical research news,

  • The Wall Street Journal seconds STAT News by reporting
    • “There is more hope than ever for people diagnosed with the deadliest cancer. 
    • “Declines in smoking and the advent of screening and newer drugs have transformed the outlook for patients with lung cancer, once considered a death sentence. Progress against the disease has propelled the drop in overall cancer deaths in the U.S. over the past three decades.
    • “And there is more to gain. More patients can fend off the disease for months or years with targeted or immune-boosting drugs, [e.g., Tagrisso] results released this weekend at a top cancer conference showed. That includes patients with forms of the disease that are notoriously tough to treat.”
  • Fortune Well offers the “best science-backed strategies for a strong mind as you age.
  • The New York Time helps readers distinguish among spring allergies, the common cold, and Covid. This article reminded the FEHBlog that the Covid public health emergency ended a year ago last month.

From the U.S. healthcare business front,

  • “Fortune Well informs us a “longevity scientist’s three surprising predictions for the growing industry of healthy aging. The longevity scientist is “Alina Su, CEO of precision medicine and health tech company Generation Lab, at Fortune’s Brainstorm Health conference in Dana Point, Calif., last week. 
  • The Washington Post explains how “author and hospitality guru Chip Conley wants to replace the midlife crisis with a midlife renaissance.”
    • “In his book “Learning to Love Midlife: 12 Reasons Why Life Gets Better With Age,” Conley, 63, asks: “What if we could reframe our thinking about the natural transition of midlife not as a crisis, but as a chrysalis — a time when something profound awakens in us, as we shed our skin, spread our wings, and pollinate our wisdom to the world?”

 

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Federal News Network tells us,
    • “The Biden administration, having struggled in some cases to set cybersecurity requirements for critical infrastructure, sees a new plan for minimum cyber standards coming together by early 2025.
    • “That’s according to Caitlin Durkovich, special assistant to the president and deputy homeland security advisor for resilience and response. During an event on Thursday hosted by the ICS Village, Durkovich spoke about the Biden administration’s efforts to implement a recently signed national security memorandum on critical infrastructure security.
    • “One of the reasons that we pushed so hard to make sure this NSM was signed out when it was, was so we had some runway to drive the implementation,” Durkovich said. “The president essentially signed it 270 days until the end of his first term. We wanted that first term to be able to implement the majority of actions.”
  • The Wall Street Journal reports,
    • “The U.S. Department of Health and Human Services doesn’t want to get caught flat-footed by the next healthcare hack. 
    • “The agency is leading work to create a map of the cybersecurity risks inherent in having a single technology supplier dominate a particular aspect of the market, a threat known as a single point of failure. The concern comes after a cyberattack on UnitedHealth Group’s Change Healthcare unit early this year produced cascading effects on health claims, freezing millions of dollars in payments. The repercussions took care providers, regulators and lawmakers by surprise.”
  • Yesterday, HHS added the following guidance to its Change Healthcare cyberattack FAQs:
    • “Covered entities affected by the Change Healthcare breach may delegate to Change Healthcare the tasks of providing the required HIPAA breach notifications on their behalf.
    • “Only one entity – which could be the covered entity itself or Change Healthcare – needs to complete breach notifications to affected individuals, HHS, and where applicable the media.
    • “If covered entities work with Change Healthcare to perform the required breach notifications in a manner consistent with the HITECH Act and HIPAA Breach Notification Rule, they would not have additional HIPAA breach notification obligations.
    • “The new and updated FAQs on the Change Healthcare Cybersecurity Incident may be viewed at: https://www.hhs.gov/hipaa/for-professionals/special-topics/change-healthcare-cybersecurity-incident-frequently-asked-questions/index.html.”

From the cyber vulnerabilities and breaches front,

  • The Cybersecurity and Infrastructure Security Agency (CISA) added the following known exploited vulnerabilities to its catalog this week:
  • Cybersecurity Dive adds,
    • The National Institute of Standards and Technology expects to clear the towering backlog of unanalyzed vulnerabilities in the National Vulnerability Database by the end of September, the agency said in a Wednesday update.
    • NIST scaled back its activities on the NVD program in mid-February following a change in interagency funding support and a staggering deluge of CVE disclosures. The agency reported an all-time high of 33,137 vulnerabilities last year, according to Flashpoint research.
    • To help clear the logjam, the agency awarded a cybersecurity analysis and email support contract to Maryland-based Analygence for $865,657 to support the processing of incoming vulnerabilities for the NVD, according to USAspending.gov. “We expect to begin performance the week of June 3,” Analygence COO Tom Peitler said via email.
  • HHS’s Health Sector Cybersecurity Coordination Center posted a “Healthcare Sector DDoS Guide.”
    • “A Distributed-Denial-of-Service (DDoS) attack is a type of cyber attack in which an attacker uses multiple systems, often referred to as a botnet, to send a high volume of traffic or requests to a targeted network or system, overwhelming it and making it unavailable to legitimate users. With the number of attacks increasing every year, they can come at any time, impact any part of a website’s operations or resources, and lead to massive amounts of service interruptions and huge financial losses. In the health and public health (HPH) sector, they have the potential to deny healthcare organizations and providers access to vital resources that can have detrimental impact on the ability to provide care.
    • “Disruptions due to a cyber attack may interrupt business continuity by keeping patients or healthcare personnel from accessing critical healthcare assets such as electronic health records, software based medical equipment, and websites to coordinate critical tasks. As such, this comprehensive DDoS guide is intended for target healthcare audiences to understand what DDoS attacks are; what causes them; types of DDoS attacks with timely, relevant examples; and mitigations and defenses against a potential attack.”

From the ransomware front,

  • Beckers Hospital Review lets us know,
    • “Most attacks on U.S. healthcare are coming from Russia, ABC affiliate KGTV reported May 28. 
    • “John Riggi, national advisor for cybersecurity and risk at the American Hospital Association, told the publication that ransomware attacks targeting hospitals have increased by more than 300%, with most of these attacks coming from Russia.
    • “The Russian government refuses to cooperate with U.S. law enforcement on these issues, therefore providing them safe harbor,” he told the news outlet.
    • “Mr. Riggi noted that ransomware gangs have also been identified operating in China, North Korea and Iran.
    • “The hacking groups most actively targeting healthcare as of April 2024 were LockBit, BlackCat/ALPHV and BianLian, according to HHS’ Health Sector Cybersecurity Coordination Center, or HC3.”
  • CSO adds,
    • “Two weeks ago, the UK National Crime Agency and the US Department of Justice announced unmasked the Russian national alleged to be the creator and administrator of the LockBit ransomware program.
    • “Now, cybersecurity company NCC Group reports that for the first time in eight months, LockBit has also been overtaken by Play as the world’s top ransomware gang, with 32 attacks in April compared to LockBit’s 23 attacks.”
  • Bloomberg informs us,
    • “It’s time to formally stop ransom payments.
    • “That’s the argument that a top cybercrime researcher — one who until recently staunchly opposed such a ban — made to scores of threat intelligence experts who gathered last week in a darkened basement ballroom at a hotel not far from the US Capitol.
    • “Banning ransom payments is an extreme step but it also might be the least bad option available to us,” Allan Liska, a threat analyst at the cyber firm Recorded Future, told the crowd. * * *
    • “On stage, Liska said he’s aware of the counter arguments: A ban won’t work to stop attacks, and blocking companies paying ransoms will do them harm. But, he said, what companies are doing now hasn’t stopped attacks either. While blocking payments might hurt some companies, so do the breaches themselves, he said. 
    • “Afterwards, Liska told me he was “dragged kicking and screaming” into opposing ransom payments. The unrelenting pace of attacks last year convinced him that it was time to take a radical step. 
    • “It’s not because I think it’s a good idea. It’s because, right now, nothing else has worked and we need to do something,” he said. “I don’t know what else it could possibly be.”

From the cyber defenses front,

  • Cyberscoop relates,
    • “A coalition of international law enforcement agencies carried out what they said was the “largest ever” operation to counter botnet and dropper malware by taking down or disrupting more than 100 servers, seizing 2,000 domains and identifying nearly 70 million euros earned by one of the main suspects in the case. 
    • “Officials with Europol announced early Thursday that “Operation Endgame” targeted droppers — malware used to get other malware onto a system — used extensively to facilitate a range of consequential cybercrimes, including IcedID, SystemBC, Pikabot, Smokeloader, Bumblebee and Trickbot.
    • “As part of the operation, authorities made one arrest in Armenia and three in Ukraine, and eight suspects linked to the activities and wanted by Germany will be added to Europe’s Most Wanted list, Europol said in its statement.”
  • Modern Healthcare reports,
    • “Healthcare’s cybersecurity challenges have shined a light on how the industry has failed to protect patient data by not dedicating enough resources to address the problem.  
    • “Health systems and insurers are dealing with the aftermath of the industry’s latest large-scale ransomware attacks on St. Louis-based Ascension, UnitedHealth Group’s Change Healthcare and Chicago-based Lurie Children’s Hospital, among others. Conversations are happening over whether organizations should be bringing in outside consultants or hiring more employees, executives say.
    • “Do we have enough people? Do we need consulting help to accelerate resiliency projects and testing? Those are the conversations going on right now,” said James Case, chief information security officer at Jacksonville, Florida-based Baptist Health. “The current climate is causing us to bubble those conversations to the top, and whether we should get help one way or another.”  
  • Here’s a link to Dark Reading’s CISO Corner.

Friday Factoids

David Ermer–AHRQ, CDC, COVID-19, FDA, Medicare, Mental health care, NCQA, No Surprises Act, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Bloomberg News reports,
    • “Federal agencies are aiming to issue final regulations this year that aim to make the arbitration process more efficient for No Surprises Act health care payment disputes, an IRS official said.
    • “The regulations are a priority for the Treasury, Labor, and Health and Human Services departments, said IRS Office of Chief Counsel Senior Technician Reviewer Kevin Knopf during a Thursday panel at the Federal Bar Association’s Insurance Tax Seminar.
    • “The proposed rules aim to reduce certain administrative fees tied to participating in an independent dispute resolution system that arbitrates clashes between medical providers and health insurers over payments. They also aim to clarify requirements to prove that a dispute is eligible for the dispute resolution process.” 
  • The Department of Health and Human Services (“HHS”) announced,
    • “Today, on National Heat Awareness Day, the U.S. Department of Health and Human Services (HHS) is launching a new tool to help communities prepare for extreme heat and prevent heat-related illness, especially among those most at risk. The Heat and Health Index (HHI) is the first nationwide tool to provide heat-health outcome information at the ZIP code level. The HHI will help state and local officials identify communities, at the zip code level, most likely to experience negative health outcomes from heat, ensure that outreach and medical aid reach the people who need it most, and help decision-makers prioritize community resilience investments.”
  • The National Committee for Quality Assurance released a fact sheet about Mental Health Awareness Month, which ended today.
  • HHS’s Agency for Health Research and Quality tells us,
    • “As we round out Older Americans Month, it is crucial that we continue to recognize the significant contributions of older adults and the urgent need to transform and improve their healthcare. Our current system is ill-equipped to meet the complex needs of older adults, who often contend with multiple chronic conditions. This inadequacy leads to fragmented and sub-optimal care, resulting in poor health outcomes, avoidable adverse events, hospitalizations, institutionalization, and increased costs. 
    • “To meet these challenges, AHRQ remains committed to using its research capabilities to build the evidence base and identify solutions ready for action. To do so, the agency has released a Special Emphasis Notice to announce its strong interest in funding health services research to improve care quality for older adults.  Research proposals for enhancing service access, delivery, organization, and equitable distribution are welcome. In particular, AHRQ seeks research to address critical questions related to the development, implementation, evaluation, and scalability of person-centered models of care to optimize older adults’ physical and mental health, functional status, and overall well-being.” 
  • BioPharma Dive informs us,
    • The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer.
    • The vaccine, dubbed mResvia, is for the prevention of disease caused by respiratory syncytial virus, or RSV, in adults 60 years of age and older. Experts from the Centers for Disease Control and Prevention are expected to meet next month to provide recommendations on the shot’s use. Moderna had said it expects the vaccine to be available in time for the fall immunization season in the U.S.
  • The Centers for Disease Control (CDC) adds,
    • “The RSV vaccine is not currently an annual vaccine, meaning people do not need to get a dose every RSV season. Currently, CDC recommends only a single dose of RSV vaccine for adults ages 60 and older, using shared clinical decision-making. Additional surveillance and evaluation activities are ongoing to determine whether older adults might benefit from receiving additional RSV vaccines in the future. So far, RSV vaccines appear to provide some protection for at least two RSV seasons.”

From the public health and medical research front,

  • HHS posted a “Fact Sheet: In Response to H5N1, HHS and USDA Focus on Protecting Farmworkers.” For more information on the ongoing response, please visit FDA, CDC, and USDA’s ongoing H5N1 update pages.
  • STAT News reports,
    • “There are a lot of reasons why updated data on Pfizer’s Lorbrena, a treatment for non-small cell lung cancer, might not seem to be a big deal. The results are an update on the clinical trial that resulted in the Food and Drug Administration granting Lorbrena full approval in 2021, so in a sense they are not even that new. For Pfizer investors, Lorbrena isn’t that big a deal, either. The medicine, for patients whose lung tumors have particular genetic mutations, generated only $575 million last year — an amount that is up 57% from the year prior, but that still constitutes only 1% of the drug giant’s annual sales.
    • “But there is one number that makes the Lorbrena data quite eye-catching: In the updated data, the daily pill decreased the risk that cancer would progress or that a patient would die by 81% over five years.
    • “That’s a stunning number, especially when one considers that Lorbrena was not being compared to an inert placebo but to Xalkori, another Pfizer targeted cancer drug.
    • “Put a different way, 60% of the patients who received Lorbrena were alive and had not seen their tumors progress in the five years of the study, compared to 8% who received Xalkori.
    • “The data are being presented at the annual meeting of the American Society of Clinical Oncology and published in the Journal of Clinical Oncology.“
  • BioPharma Dive informs us,
    • “People with chronic myeloid leukemia, a simmering cancer of the bone marrow, are often treated with one of several targeted drugs that, over the past two decades, have helped to substantially prolong survival from the disease.
    • “Study results revealed Friday suggest that Scemblix, the newest of those therapies, can be both safer and more effective, potentially supporting wider use of it as an initial treatment. The results are from a late-stage clinical trial run by Scemblix’s maker, Novartis, and will be presented at the American Society of Clinical Oncology’s annual meeting.
    • “In the trial, dubbed ASC4FIRST, Scemblix led to treatment responses in significantly more participants than did other targeted drugs, which included the mainstay therapy Gleevec as well as more recently introduced medicines. Additionally, more people given Novartis’ drug experienced what’s called a “deep molecular response,” which over time can be considered a remission and allow treatment to be stopped.
    • “Study researchers also reported “markedly favorable safety and tolerability” for Scemblix, compared to Gleevec and the other so-called kinase inhibitors it was tested against.”
  • Medscape notes,
    • A personalized diet, created by integrating microbiome analysis with artificial intelligence (AI) algorithms, is a promising approach to the management of irritable bowel syndrome(IBS) symptoms, leading to enhanced symptom relief and greater gut microbiome diversity than a standard low–fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet, new research suggests.
  • and
    • “About 9 out of 10 people will have a genetic difference in their DNA that can impact how they respond to common medications,” said Emily J. Cicali, PharmD, a clinical associate at the University of Florida College of Pharmacy, Gainesville, Florida.
    • “Cicali is the clinical director of UF Health’s MyRx, a virtual program that gives Florida and New Jersey residents access to pharmacogenetic (PGx) tests plus expert interpretation by the health system’s pharmacists. Genetic factors are thought to contribute to about 25% or more of inappropriate drug responses or adverse events, said Kristin Wiisanen, PharmD, dean of the College of Pharmacy at Rosalind Franklin University of Medicine and Science in North Chicago, Illinois.
    • “Pharmacogenetics helps consumers avoid drugs that may not work well for them or could cause serious adverse events. It’s personalized medicine,” Cicali said.
    • “Through a cheek swab or blood sample, the MyRx program — and a growing number of health system programs, doctors’ offices, and home tests available across the United States — gives consumers a window on inherited gene variants that can affect how their body activates, metabolizes, and clears away medications from a long list of widely used drugs.”
  • The Wall Street Journal recounts the experiences of readers months after stopping GLP-1 drug treatment.

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute relates.
    • According to findings of the Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey, most plan enrollees are satisfied with their health plan, but high-deductible health plan (HDHP) enrollees are less likely to be extremely or very satisfied than traditional plan enrollees.
    • HDHP and traditional plan enrollees are both satisfied with the quality of care received and choice of doctors.
    • Differences in overall satisfaction may be driven by cost sharing. HDHP enrollees are less likely than traditional plan enrollees to be extremely/very satisfied with out-of-pocket expenses for prescription drugs and other health care services.
  • Beckers Hospital Review reports,
    • “The Justice Department has rejected bankrupt Dallas-based Steward Health Care’s suggested auction timeline for its physician group Stewardship Health to be sold to UnitedHealth Group’s subsidiary Optum. 
    • “In a May 28 bankruptcy court filing, obtained by Becker’s, Brian Boynton, principal deputy attorney general for the justice department, detailed how the debtor-in-possession financial deal between Steward and its landlord Medical Properties Trust interferes with the health system’s “obligation to comply with the United States’ antitrust review” of the Stewardship Health, Optum deal and should not be approved.”
  • and calls attention to an American Hospital Association report identifying the inpatient and outpatient services that are biggest money losers for hospitals.
  • Healthcare Dive points out,
    • “Most of the nation’s leading nonprofit healthcare providers reported progress toward financial recovery during earnings for the quarter ended March 31.
    • “However, improvements varied widely by health system, and the industry at large has a long way to go before it is back to profitability levels enjoyed pre-pandemic — if it fully rebounds at all, analysts told Healthcare Dive.
    • “Nonprofits struggled with cost challenges, confirming reports from analysts at credit rating agencies Moody’s Ratings and Fitch Ratings that predicted expenses, particularly labor costs, would continue to vex providers in 2024.
    • “Analysts also expected this year to bring a bifurcated financial recovery for the sector, where health systems that could successfully contain costs would recover more quickly.
    • “With early financial data now in for 2024, that expectation appears to be playing out.”

Thursday Miscellany

David Ermer–CDC, CMS, Medical / Rx research, Mental health care, NIH, Telehealth, U.S. Healthcare, Wellness–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced,
    • Today the U.S. Department of Health and Human Services, through its Administration for Community Living, released “Aging in the United States: A Strategic Framework for a National Plan on Aging – PDF.” The report lays the groundwork for a coordinated effort – across the private and public sectors and in partnership with older adults, family caregivers, the aging services network, and other stakeholders – to create a national set of recommendations for advancing healthy aging and age-friendly communities that value and truly include older adults. The national plan on aging will advance best practices for service delivery, support development and strengthening of partnerships within and across sectors, identify solutions for removing barriers to health and independence for older adults, and more. Developed by leaders and experts from 16 federal agencies and departments working together through the Interagency Coordinating Committee (ICC) on Healthy Aging and Age-Friendly Communities, the report also reflects input from community partners and leaders in the aging services network.
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa Gomez, reminds us,
    • “May is Mental Health Awareness Month, reminding us of the critical need to prioritize mental well-being – especially in the workplace where many spend a significant portion of their time. Did you know that more than 1 in 5 adults in America live with a mental illness? Mental health issues can affect job performance, relationships and overall well-being. Understanding your rights and support systems can make a world of difference. 
    • “Here are three actions you can take to get the mental health care you deserve through your job-based health plan: 
    • “Use your benefits: * * * For more information, read our publication “Understanding Your Mental Health and Substance Use Disorder Benefits.”
    • “Don’t take no for an answer: * * * You also can look at our publication “Filing a Claim for Your Benefits” for steps to help navigate this process. 
    • “Contact the Department for help:  Know that support for your mental health journey is available – you don’t have to go through it alone. One source of support is found by contacting a benefits advisor with the Department’s Employee Benefits Security Administration at askebsa.dol.gov or by calling 1-866-444-3272 for assistance with any questions or problems you encounter when trying to use the mental health and substance use disorder benefits under your job-based health plan. The benefits advisors can help you understand your rights, your health plan and its appeal process.”
  • The American Hospital News lets us know,
    • “The Centers for Disease Control and Prevention May 29 published a blog co-authored by AHA, the National Institute for Occupational Safety and Health and the Agency for Healthcare Research and Quality, highlighting efforts by federal agencies and the hospital field to address the mental health and well-being of health care workers following incidents of workplace violence. The blog contains several resources, such as AHA’s Hospitals Against Violence Initiative, the Building a Safer Workplace and Community infographic, and information about #HAVhope Friday on June 7 * * *.
  • HR Dive informs us,
    • “Employers run afoul of federal law when they fire someone for not disclosing a disability during a job interview or for waiting until after they were hired to ask for an accommodation, the U.S. Equal Employment Opportunity Commission warned in a May 21 lawsuit.
    • “Per the complaint in EEOC v. All Day Medical Care Clinic, LLC, on her first day of work, a scheduling assistant for a Maryland-based healthcare provider notified the CEO she had a vision impairment and needed a magnifier and Zoomtext software as an accommodation. The CEO allegedly advised her that things would have been different if she’d mentioned her disability and accommodation needs during her interview and told her to leave, according to court documents.
    • “The EEOC sued the healthcare provider for allegedly violating the Americans with Disabilities Act. Under the ADA, “job applicants do not need to reveal their disabilities before being hired,” Debra Lawrence, regional attorney for the EEOC’s Philadelphia district office, explained in a press release. “When an employer penalizes an employee for not raising issues of disability and reasonable accommodation, it is requiring the employee to reveal information the employee legally does not have to divulge,” Lawrence said. All Day Medical Care did not respond to a request for a comment prior to press time.”

From the public health and medical research front,

  • The New York Times reports,
    • “A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.”A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.
    • “The worker is the first in this outbreak to have respiratory symptoms, including a cough, sore throat and watery eyes, which generally increase the likelihood of transmission to other people, federal officials said on Thursday.
    • “The other two people had only severe eye infections, possibly because of exposure to contaminated milk.
    • “All three individuals had direct exposure to dairy cows, and so far none has spread the virus to other people, Dr. Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention, said at a news briefing.”
  • The National Institutes of Health announced,
    • “Using a combination of cutting-edge immunologic technologies, researchers have successfully stimulated animals’ immune systems to induce rare precursor B cells of a class of HIV broadly neutralizing antibodies (bNAbs). The findings, published today in Nature Immunology, are an encouraging, incremental step in developing a preventive HIV vaccine.”
  • The Institute for Clinical and Economic Review released,
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).”its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).
    • “COPD is a common cause of severe respiratory problems,” said ICER’s Chief Medical Officer, David Rind, MD. “People with COPD can experience persistent shortness of breath and fatigue that can significantly affect their daily activities. Current evidence shows that ensifentrine decreases exacerbations when used in combination with some current inhaled therapies and is well-tolerated by patients, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments.” * * *
    • “Key Clinical Findings“Key Clinical Findings
      • “ICER does not have significant concerns about harms with ensifentrine. We have high certainty that ensifentrine added to maintenance therapy, compared with maintenance therapy alone, results in at least a small net health benefit, and may result in substantial net health benefit (“B+”). We have somewhat greater certainty in the benefits when ensifentrine is added to the regimens studied in the clinical trials than when added to optimized modern inhaler therapies for COPD.
    • “Key Cost-Effectiveness Findings
      • “Ensifentrine has not yet been approved by the FDA, and the manufacturer has not announced a US price if approved. ICER has calculated a health-benefit price benchmark (HBPB) for ensifentrine to be between $7,500 to $12,700 per year.”
  • The Centers for Medicare Services is contemplating moving coverage of PreExposure Prophylaxsis using Antiviral Therapy to prevent HIV infection from Medicare Part D to Medicare Part B.
  • The Wall Street Journal relates,
    • “Screens are inherently harmful to our sleep, right?
    • “It isn’t that black and white, some sleep experts now say.
    • “Spurred by recent research, sleep scientists and doctors are rethinking the conventional wisdom. In some cases, they are backing away from dogmatic approaches such as cutting out screens two hours before bedtime. And they are questioning how much the dreaded “blue light” actually delays sleep.
    • “It is becoming more evident that the tech in and of itself isn’t always the problem,” says Shelby Harris, a clinical psychologist specializing in behavioral sleep medicine in New York. “We need to figure out how to tailor the recommendations to the person.”
  • Mercer Consulting discusses “Help for opioid addiction: Some progress, much more to do.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues shares the views of 32 payer executives about changes to healthcare delivery in the next ten years. For example,
    • Bruce Rogen, MD. Chief Medical Officer of Cleveland Clinic Employee Health Plan: Longitudinal patient records on each patient accessible by providers caring for the patient having a complete history of clinical data sourced from multiple EMRs and across payers and over time going back years if not decades.
    • AI platforms that are able to access the longitudinal patient record to engage the patient in preventive care, filling gaps in care, managing medication refills, enhancing medication compliance, and obtaining prior authorization from payers when indicated.
    • Teams of healthcare providers using the longitudinal patient record and the AI platforms to provide care anywhere and everywhere (hospital, post-acute, home care, remote, virtual) and focusing on prevention. The team includes physicians, nurses, navigators, care coordinators, pharmacists, social workers, behavioral health psychologists and counselors, community healthcare workers and home care workers.
    • Ilan Shapiro, MD. Chief Health Correspondent, Medical Affairs Officer and Senior Vice President at AltaMed (Los Angeles): In 10 years, healthcare delivery will likely be more patient-centric and value-based, with AI technology playing a crucial role in both treatment and prevention of illnesses. Patients will be incentivized for proactive wellness steps, fostering a culture of health promotion. Nationwide care coordination will be streamlined, reducing constraints and enhancing accessibility. This transformation will empower patients and healthcare teams, ensuring that care is brought back to the community level.
  • Per FierceHealthcare
    • “Well-being programs continue to be a central focus for employers, and they’re evolving the reach of these offerings into new areas such as the social determinants of health, according to a new survey.
    • “The Business Group on Health and Fidelity Investments released their annual look at employers’ strategies around wellness on Wednesday, and found nearly all of the 160 surveyed firms said they view well-being programs as a being key to their overall strategy. These employers said they intend to continue funding these programs at current levels.
    • “In addition, more than half (51%) said they plan to build out their well-being programs to tackle social needs in the next three to five years.”
  • The Wall Street Journal examines the connection between private equity investments and growing healthcare costs.
    • “Consolidation is as American as apple pie.
    • “When a business gets bigger, it forces mom-and-pop players out of the market, but it can boost profits and bring down costs, too. Think about the pros and cons of Walmart and “Every Day Low Prices.” In a complex, multitrillion-dollar system like America’s healthcare market, though, that principle has turned into a harmful arms race that has helped drive prices increasingly higher without improving care. 
    • “Years of dealmaking has led to sprawling hospital systems, vertically integrated health insurance companies, and highly concentrated private equity-owned practices resulting in diminished competition and even the closure of vital health facilities. As this three-part Heard on the Street series will show, the rich rewards and lax oversight ultimately create pain for both patients and the doctors who treat them. Belatedly, state and federal regulators and lawmakers are zeroing in on consolidation, creating uncertainty for the investors who have long profited from the healthcare merger boom.”
  • STAT News considers the lack of consensus over the meaning of value-based care. Sigh.
    • “Mai Pham, president of the Institute for Exceptional Care, said her benchmark for success is not how health care providers are feeling. It’s what is actually happening to the nation’s health, and the status quo in her view is unacceptable. Life expectancy among Americans has plateaued, and life expectancy for Americans in the prime years of their lives is falling. This trend, Pham noted, started before the Covid-19 pandemic, and it’s happening across races and geography.
    • “It’s difficult to say whether value-based care has been a success. Medicare has tried a broad range of programs and strategies, each of which has involved a broad range of organizations. Some have done well, others have not.
    • “So it’s not a binary answer,” Pham said. “What I would say is that it has not lived up to the hype.”
  • mHealth Intelligence tells us,
    • “Though telehealth use skyrocketed among United States adults with private health insurance during the COVID-19 pandemic, new research reveals that rural residents utilized telehealth less than their urban peers.
    • “The research, published by the AARP Public Policy Institute last week, examined changes in telehealth use from 2019 to 2021 among people younger than 65 enrolled in private, employer-sponsored health insurance plans.”