Cybersecurity Saturday

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the CrowdStrike front,

  • The Wall Street Journal summarizes for us,
    • “CrowdStrike said over 97% of Microsoft Windows sensors were back online as of Thursday, nearly a week after a global tech outage snarled businesses, government agencies and air travel worldwide.
    • “CrowdStrike Chief Executive George Kurtz said the company still has more work to do to address the fallout from last Friday’s disruption. 
    • “To our customers still affected, please know we will not rest until we achieve full recovery,” Kurtz said Thursday in a post on LinkedIn.
    • “Kurtz again apologized for the outage. “While I can’t promise perfection, I can promise a response that is focused, effective, and with a sense of urgency,” he said.
    • “CrowdStrike said in an incident report earlier this week that a bug in a quality-control tool it uses to check system updates for mistakes allowed a critical flaw to be pushed to millions of machines running Microsoft Windows. 
    • “About 8.5 million devices were affected by the outage, CrowdStrike said Monday. Many of those machines were part of wider corporate IT systems, meaning the impact was felt more widely.” 
  • ABC News adds,
    • “An outage caused by a software update distributed by cybersecurity firm CrowdStrike triggered a wave of flight cancellations at several major U.S. airlines – but the disruption was most severe and prolonged at Delta Airlines.
    • “In all, the carrier canceled more than 2,500 flights over a period that stretched from last Friday, when the outage began, into the middle of this week.” * * *
    • “For a company such as Delta, they rely on countless partner services for everything from scheduling pilots and planes to providing meal service and snacks to allowing customers to select their seats,” David Bader, a professor of cybersecurity and the director of the Institute of Data Science at the New Jersey Institute of Technology, told ABC News.” * * *
    • “The reason for the prolonged recovery from the outage was because the CrowdStrike update disruption required a manual fix at each individual computer system, experts told ABC News. While each fix can be completed in no more than 10 minutes, the vast number of Delta’s digital terminals required significant manpower to address,” Mark Lanterman, the chief technology officer at the cybersecurity firm Computer Forensic Services, said.”
  • Per Cybersecurity Dive,
    • “Parametrix said the global IT outage linked to Crowdstrike will likely cost the Fortune 500, excluding Microsoft, at least $5.4 billion in direct financial losses, in a report released Wednesday [July 24]. 
    • “Cyber insurance will only cover 10% to 20% of the losses, based on large risk retentions and policy limits at many companies, according to Parametrix. CyberCube estimates the cyber insurance market will face preliminary insured losses of between $400 million and $1.5 billion, potentially the single worst loss in the cyber insurance sector over 20 years. 
    • “Parametrix expects the healthcare sector to see the biggest impact among industries with $1.94 billion in losses after three-quarters Fortune 500 healthcare companies were impacted. Though banking was also hard-hit, with an estimated $1.15 billion in direct losses, airlines are expected to have the highest per company costs.”
  • Dark Reading points out unexpected lessons to be gained from the CrowdStrike outage.
    • “In the wake of global IT issues caused by a defect in a content update for CrowdStrike’s Falcon sensor, many organizations engaged in executing business continuity plans (BCPs), recovering systems, and restoring from backups. In the throes of these activities, it’s easy to overlook the similarity with the playbook for ransomware recovery and miss how organizations of all sizes can leverage this event to identify gaps in their capabilities to respond to and recover from ransomware or other disruptive cyberattacks.”
  • Here is a link to CISA’s regularly updated website about the outage.

From the cybersecurity policy front,

  • Per an HHS press release on Thursday July 25,
    • “The U.S. Department of Health and Human Services (HHS) today announced a reorganization that will streamline and bolster technology, cybersecurity, data, and artificial intelligence (AI) strategy and policy functions.
    • “Opportunities in data and technology in healthcare and human services have grown significantly in recent years. Historically, responsibility for policy and operations has been distributed across the Office of the National Coordinator for Health Information Technology (ONC), the Assistant Secretary for Administration (ASA), and the Administration for Strategic Preparedness and Response (ASPR). This reorganization will clarify and consolidate these critical functions, as follows:
      • “ONC will be renamed the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC);
      • “Oversight over technology, data, and AI policy and strategy will move from ASA to ASTP/ONC, including the HHS-wide roles of Chief Technology Officer, Chief Data Officer, and Chief AI Officer; and
      • “The public-private effort between the health sector and the federal government on cybersecurity (“405(d) Program”) will move from ASA to ASPR, joining the other health sector cybersecurity activities already located in ASPR’s Office of Critical Infrastructure Protection, and advancing the Department’s one-stop-shop approach to healthcare cybersecurity.” * * *
    • “National Coordinator Micky Tripathi will be named Assistant Secretary for Technology Policy/National Coordinator for Health Information Technology.”
  • Cybersecurity Dive reported yesterday,
    • “The White House and the Cybersecurity and Infrastructure Security Agency disclosed key personnel decisions this week as the administration continues efforts to improve the nation’s resilience and cybersecurity posture. 
    • “The White House Office of the National Cyber Director named Harry Wingo the new deputy national cyber director. 
    • “Wingo, an assistant professor at the National Defense University College of Information and Cyberspace and former U.S. Navy Seal officer, will begin his new role next week, according to the White House.” * * * 
    • “The appointment comes as CISA named Bridget Bean, assistant director of integrated operations, the new executive director of the agency. Bean will succeed Brandon Wales, who is stepping down as the agency’s first executive director next month.” 
  • Here is link to CISA Director Jen Easterly’s comments on these personnel changes.
  • On Monday July 22, the HHS Inspector General posted a report titled “HHS Office of the Secretary Needs to Improve Key Security Controls to Better Protect Certain Cloud Information Systems.” TechTarget discusses the report here.
  • Per Help Net Security, here is a link to
    • [A] Help Net Security interview [with] Ava Chawla, Head of Cloud Security at AlgoSec, discusses the most significant cloud security threats CISOs must be aware of in 2024. These threats include data breaches, misconfiguration, insider threats, advanced persistent threats, ransomware, API vulnerabilities, and supply chain vulnerabilities.

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports,
    • “Stepped-up activity from a North Korean hacking group is prompting Mandiant to upgrade it to a top-tier hacking threat and the FBI to issue an alert about the outfit, which the company and agency say has long sought to obtain intelligence about defense and research and development but has since expanded to other targets.
    • “Mandiant, a cybersecurity arm of Google Cloud, said in a report it released Thursday [July 25] that the newly labeled APT45 has broadened its ransomware operations — rare for North Korean groups — to target health care providers, financial institutions and energy companies.
    • “The FBI is set to follow with an advisory and news conference Thursday about the hackers.”
  • Here is a link to a CISA press release about Thursday’s advisory and a link to a Dark Reading article on the press conference.
  • Dark Reading adds,
    • “The US Department of Justice has unsealed an indictment of a North Korean military intelligence operative targeting US critical infrastructure.
    • “The individual, Rom Jong Hyok, allegedly carried out ransomware attacks against healthcare facilities and funneled the ransom payments to arrange other breaches into defense, technology, and government organizations globally, in violation of the Computer Fraud and Abuse Act, according to the indictment.
    • “The ransom payments were laundered through Hong Kong, where they were converted into Chinese yuan, withdrawn from an ATM, and then used to purchase virtual private servers in order to exfiltrate sensitive defense and technology information.” 
  • Here is a link to the Justice Department’s press release on this action.
  • Bleeping Computer warns,
    • “American cybersecurity company KnowBe4 says a person it recently hired as a Principal Software Engineer turned out to be a North Korean state actor who attempted to install information-stealing on its devices.
    • “The firm detected and stopped the malicious actions in time, so no data breach occurred. However, the case highlights the continued threat posed by North Korean threat actors posing as IT staff, something that the FBI has warned about repeatedly since 2023.
    • “The DPRK maintains a highly organized army of IT workers who obscure their true identities to get hired by hundreds of American firms.”
  • CISA added two known exploited vulnerabilities to its catalog this week.

In other ransomware news,

  • Cybersecurity Dive reports why healthcare entities can be an easy mark for ransomware gangs.
  • Bleeping Computer tells us,
    • “Russian-speaking threat actors accounted for at least 69% of all crypto proceeds linked to ransomware throughout the previous year, exceeding $500,000,000.
    • “This number is from TRM Labs, a blockchain intelligence and analytics firm specializing in crypto-assisted money laundering and financial crime.
    • “North Korea is the leader in stealing cryptocurrency through exploits and breaches, having stolen over a billion dollars in 2023. Asia also remains the leader in scams and investment fraud.
    • “However, Russians reportedly dominate all other malicious activity involving crypto.”
  • Silicon Angle offers a 20-minute-long interview with folks from VEEAM which recently issued its “third Ransomware Trends Report, not of Veeam customers, but of the whole industry. There were 1,200 organizations that were hit with ransomware.”

From the cybersecurity defenses front,

  • The Wall Street Journal reports on July 23,
    • “Alphabet unit Google’s talks to acquire the cybersecurity startup Wiz for a planned $23 billion have fallen apart, according to a person with knowledge of the discussions.
    • “In an email to employees sent Monday and viewed by The Wall Street Journal, Wiz Chief Executive Assaf Rappaport said the company is now aiming for an initial public offering.”
  • Forbes offers “A CISO’s Guide to Fortifying Your Cybersecurity Posture.”
  • Tech Target shares a guide to cybersecurity planning for businesses and identifies “16 common types of cyberattacks and how to prevent them.”





Friday Factoids

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

From Washington, DC,

  • Medical Economics alerts us,
    • “The hot seat in Washington, D.C., could get hotter for pharmacy benefit managers (PBMs) when the Federal Trade Commission (FTC) meets next week to discuss its recent report on the drug price middlemen.
    • “Meanwhile, a consortium of pharmacy groups is demanding federal lawmakers pass reforms they say are needed to regain control of the pharmaceutical market. A PBM trade group countered that legislators need a balanced and accurate discussion, not just repetition of claims of Big Pharma, which stands to benefit if PBMs lose their price bargaining power.
    • “As public discourse about PBMs at times rises to a clamor, the FTC announced its Aug. 1 open meeting will include a presentation on the Commission’s Interim Report on Pharmacy Benefit Managers (PBMs).”
  • FEHBlog note — PBMs do a more than negotiate prices with drug manufacturers and wholesalers. For example, PBMs also seamlessly process drug claims for consumers.  
  • Beckers Hospital CFO Report tells us,
    • “The U.S. economy saw a 2.8% increase in gross domestic product in the second quarter of 2024, reflecting a spike in consumer spending, nonresidential fixed investment and private inventory investment. 
    • “The first quarter saw GDP grow only 1.4%, according to the Bureau of Economic Analysis.
    • “Consumer spending also increased in goods and services. Healthcare, utilities, recreation services, and housing led service contributors. Motor vehicles and parts, furnishing and durable household equipment, gasoline and recreational goods led goods contributors.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention (“CDC”) announced today,
    • “Summary
      • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity has increased in most areas.
    • “COVID-19
      • “Most areas of the country are experiencing consistent increases in COVID-19 activity. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are increasing, particularly among adults 65+. Surges like this are known to occur throughout the year, including during the summer months. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • The University of Minnesota CIDRAP adds,
    • “Nationally, wastewater detections of SARS-CoV-2 have been at the high level over the past few weeks, with the highest levels in Western states over the summer months. However, the CDC’s latest data show though detections in the West are still the highest in the nation, the level declined in the most recent reporting week.
    • “Wastewater detections are still rising steadily in the South. In the Midwest and Northeast, detections are still increasing, but at a slower pace.”
  • STAT News points out,
    • “The number of confirmed human infections with the bird flu virus associated with the ongoing outbreak in dairy cattle has risen to 13, the Centers for Disease Control and Prevention announced Thursday, as it confirmed three additional cases in Colorado. They are currently designated simply as H5 and not H5N1 because CDC labs are still working on typing the neuraminidase, the N number in the virus’ name, STAT’s Helen Branswell reports.
    • “The cases — one of which Colorado had previously announced as a “presumptive positive” — are in people who were culling infected poultry on a farm in the state. Genetic analysis of the virus in that poultry outbreak shows that it is similar to the virus circulating in cows; it’s believed this is one of several instances where H5N1 in cow herds has spilled over into nearby poultry operations. Of the 13 human cases, 10 have been detected in Colorado, which also has the highest number of reported infected dairy herds — 51, according to the state’s Department of Agriculture. Michigan and Texas have reported two and one human case, respectively.”
  • The Detroit Free Press reports,
    • “Liverwurst and several other deli meat products produced by Boar’s Head Provisions Co., Inc., based in Jarratt, Virginia, are being recalled because they may be contaminated with the Listeria monocytogenes bacteria, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) on Friday announced.
    • “Additional deli meat products produced on the same line and same day as the liverwurst are also being recalled because of potential listeria contamination.
    • “In total, more than 207,000 pounds of products are being recalled.
    • “The FSIS is concerned because some products may be in consumers’ refrigerators and in retail deli cases.”
  • MedPage Today discusses issues with the CDC’s bird flu virus vaccine.
  • Mercer Consulting explains why GLP-1 drug dislocation calls for a holistic approach to weight-loss.
  • U.S. News and World Report informs us,
    • “Cancer growth can be fueled by flecks of ancient viral DNA lodged into the genetics of modern humans, a new study says.
    • “Overall, about 8% of the human genome is made of bits of DNA left behind by viruses that infected our primate ancestors, researchers say.
    • “Called “endogenous retroviruses,” these DNA fragments have long been considered harmless junk littering the modern human genetic profile, researchers said.
    • “But new research shows that when reawakened, these ancient viral strands can help cancer survive and thrive, researchers reported July 17 in the journal Science Advances.
    • “What’s more, shutting up these viral voices from the past can make cancer treatments more effective, researchers found.
    • “Our study shows that diseases today can be significantly influenced by these ancient viral infections that until recently very few researchers were paying attention to,” said senior researcher Edward Chuong. He’s an assistant professor of molecular, cellular and developmental biology at the University of Colorado, Boulder’s BioFrontiers Institute.”

From the U.S. healthcare business front,

  • The Wall Street Journal looks at the drug shortage problem from the perspective of a courageous American who invested in a failing Amoxicillin plant located in Bristol, TN.
    • “A cavernous factory in northeastern Tennessee, by the Virginia border, is one of the last in the country that makes a vitally important medicine.
    • “Each day the USAntibiotics plant churns out a million doses of the crucial antibiotic amoxicillin that promise to cure Americans of everything from earaches to pneumonia—and ease a pressing shortage for children.
    • “But the plant’s prospects are dim. It can’t charge enough to cover overhead, because competitors sell their wares at bargain prices. USAntibiotics isn’t close to breaking even.
    • “It’s not for lack of trying,” said Rick Jackson, a health-staffing businessman who rescued the factory from near bankruptcy two years ago and has poured more than $38 million into purchasing and refurbishing it.
    • “The generic drug business has become a hostile environment for American companies. Prices for the often-critical medicines have dropped so low that it has become difficult for U.S. manufacturers to compete with companies overseas.”  * * *
    • “Jackson is holding out hope the federal government will help the plant. But if it doesn’t in the next year and a half, he said would shut the factory down.
    • “It’s not a failure yet,” Jackson said. “If there is a way to do it, we’ll figure it out.”
    • FEHBlog note – Hopefully the front-page WSJ article will help generate outside investment.
  • Per BioPharma Dive,
    • “Bristol Myers Squibb on Friday raised its forecast for revenue and profit per share this year after a second quarter in which sales of its older products and new drugs surpassed analyst expectations.
    • “The “beat and raise” followed similarly strong earnings reports this week from AstraZeneca, Roche, Sanofi and AbbVie, all of which upped either their revenue or profit estimates for 2024. Shares in Bristol Myers rose by nearly 9% in Friday morning trading on the news.
    • “Between April and June, Bristol Myers reported earning $12.2 billion in sales, 6% higher than Wall Street consensus forecasts. Second quarter earnings per share were $2.07 on an adjusted basis, 27% higher than estimated, according to Leerink Partners analysts.”Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies.[1] The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.
  • Cardiovascular Business reports,
    • “Researchers have developed artificial blood vessels that could be as strong and durable as the real things, publishing their work in Advanced Materials Technologies. The group hopes its work could go on to make a significant impact in care for heart bypass patients.
    • “A team with the University of Edinburgh developed the synthetic vessels using 3D-printing technology. First, a “rotating spindle integrated into a 3D printer” was used to print grafts out of a water-based gel. Those grafts are then coated in biodegradable polyester molecules. 
    • “If these “strong, flexible, gel-like tubes” can gain enough momentum among healthcare providers, lead author Faraz Fazal, PhD, and colleagues think many of the complications associated with removing human veins during bypass operations could be avoided altogether. 
    • “Our hybrid technique opens up new and exciting possibilities for the fabrication of tubular constructs in tissue engineering,” Fazal said in a statement. 
    • “The results from our research address a long-standing challenge in the field of vascular tissue engineering – to produce a conduit that has similar biomechanical properties to that of human veins,” added co-author Norbert Radacsi, PhD.”
    • FEHBlog note: Bravo.

Thursday Miscellany

David Ermer–CDC, Congress, Medical / Rx research, NCQA, Obesity, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • [On Monday July 21, the House of Representatives passed] “the Billion Dollar Boondoggle Act, was already approved by the Senate in March. 
    • “It would require agencies to report annually to Congress about their projects that are more than five years behind schedule or are $1 billion or more over budget. 
    • “Specifically, the measure would require an explanation for the delay or cost increase as well as a justification for any award, incentive fee or other type of bonus awarded with respect to the project. 
    • “It’s a bad day for boondoggles, but a very good one for taxpayers!” bill sponsor Sen. Joni Ernst, R-Iowa, said in a statement following House passage.” 
  • and
    • “The House also cleared the GOOD Act, which would mandate agencies to post their guidance documents online in a single location on the day they are issued. 
    • “Unfortunately, agency guidance documents are difficult to find, leaving Americans and small businesses guessing, and oftentimes struggling, to comply with the law. The Guidance Out of Darkness Act rights this wrong by requiring federal agencies to be transparent about interpretations of the law through publishing guidance in an easily accessible, online location,” said House Oversight and Accountability Chairman James Comer, R-Ky., who also sponsored the bill, in a statement. “Laws should not be implemented based on guidance that’s kept in the dark.”
    • “It also would require agencies to publish previously issued guidance documents that are still in effect to the same website.”
    • This bill now goes to the Senate for consideration.
  • Govexec also informs us,
    • “The Office of Personnel Management on Thursday finalized new regulations intended to ensure that federal workers who are temporarily promoted are paid appropriately for the duration of their detail.” * * *
    • “The new rule will go into effect on Aug. 26. In a memo to agency HR directors, OPM Associate Director for Workforce Policy and Innovation Veronica Hinton sought to reassure agencies that the new rule only applies in certain circumstances, providing an FAQ on the issue.”
  • The Washington Post tells us,
    • “A Senate committee Thursday formally opened a bipartisan investigation into Steward Health Care, the nation’s largest physician-led hospital system, and voted to subpoena the company’s CEO, alleging that Steward executives had mismanaged the system’s finances and put patient care at risk.
    • “Steward, a for-profit company that owns 31 hospitals across the country, is in bankruptcy proceedings and has been seeking to sell its hospitals. Community leaders and health workers in states served by Steward’s facilities, such as Massachusetts, have blamed Steward leaders for extravagant paydays even as hospitals struggled to meet mortgage payments and cover other expenses. The Justice Department also has been probing the company over allegations of fraud.”
    • “Senators on the Health, Education, Labor and Pensions Committee echoed those concerns Thursday and said Steward warranted a national spotlight on Capitol Hill, accusing the hospital system’s leaders of “outrageous corporate greed” that harmed access to medical services, such as spending nearly $100 million on a pair of private jets. Lawmakers on the committee have been investigating the system for months.”

From the public health and medical research front,

  • The Washington Post relates,
    • “A twice-yearly injection could help prevent HIV infections, according to the results of a new study described by medical experts as a breakthrough.
    • “In a randomized trial involving more than 5,000 young women and girls in South Africa and Uganda, none of those who received the prevention shots contracted HIV. The results were published in the New England Journal of Medicine on Wednesday.
    • “This appears to be a new breakthrough for HIV prevention. If these injections can be widely distributed at low cost, it would dramatically reduce the risk of new HIV infections worldwide,” said Sarah Palmer, co-director of the Center for Virus Research at the Westmead Institute for Medical Research in Sydney, who was not involved in the peer-reviewed study. “It is especially encouraging this research focused on young women in Africa who are so highly at-risk for HIV infection.” * * *
    • “The shots were produced by drugmaker Gilead Sciences, which funded the trial, and some of the researchers were Gilead employees. Lenacapavir, sold under the brand name Sunlenca, is approved as a treatment for HIV infections in the United States. The goal of the trial was to prove its safety and efficacy for the prevention of infection in adolescent girls and young women. A separate trial for men is underway.”
  • ‘The New York Times reports,
    • “For the more than 310,000 women diagnosed with breast cancer every year, no matter how well the treatment goes, there is always a lingering fear. Could the disease come back, even years later? And what if it comes back in the other breast? Could they protect themselves today by having a double mastectomy?
    • “A study has concluded that there is no survival advantage to having the other breast removed. Women who had a lumpectomy or a mastectomy and kept their other breast did just as well as women who had a double mastectomy, Dr. Steven Narod of Women’s College Hospital in Toronto and his colleagues reported, using U.S. data from more than 661,000 women with breast cancer on one side.
    • “In the study, published in JAMA Oncology on Thursday, the researchers added that most women did very well — the chance of cancer in the other breast was about 7 percent over 20 years.
    • “But the study’s results may not apply to women who have a gene variant, BRCA1 or BRCA2, which greatly increases their cancer risk. For the 1 in 500 American women with this variant, cancer researchers agree that it’s worth considering a double mastectomy.” * * *
    • “Dr. Angela DeMichele, a professor of medicine and co-leader of the breast cancer program at the University of Pennsylvania “says she carefully explains to patients that they have a real choice in treatment — they don’t have to have a double mastectomy.
    • “Many women, she said, assume that the more surgery they have, the more likely they are to be cured. So, they want both breasts removed.
    • “She tells them that removing the second, healthy breast does not prevent cells from their newly diagnosed cancer from spreading to other organs and to bones. “That is why chemotherapy and hormonal therapies are so important,” she tells patients. “They are designed to kill these cells.”
  • Per Beckers Hospital Review,
    • “A newly tested combination therapy showed a higher rate of survival compared to chemotherapy alone, according to a study published July 24 in The New England Journal of Medicine.
    • “Researchers from academic institutions including Mayo Clinic in Rochester, Minn., and the Dana-Farber Cancer Institute in Boston, conducted a clinical trial testing the combination therapy of blinatumomab plus chemotherapy on the survival rates of patients with B-cell precursor acute lymphoblastic leukemia.” * * *
    • “These results are encouraging and establish a new standard of treatment for people with BCP-ALL. The addition of blinatumomab to chemotherapy reduced the risk of leukemia recurrence and death by nearly 60%,” Mark Litzow, MD, lead study author and hematologist at the Mayo Clinic Comprehensive Cancer Center, said in a July 24 news release from the Mayo Clinic.” 
  • and
    • “About 28% of knee and hip replacements are performed on people younger than 55 and the trend is expected to grow, U.S. News & World Report reported July 24.
    • “By 2030, people younger than 65 are expected to account for 52% of hip replacements and 62% for total knee replacements, according to research presented at the American Academy of Orthopedics’ annual meeting in 2023. Researchers utilized data from 5,153 patients in the American Joint Replacement Registry that had a total hip arthroplasty performed between 2012 and 2020.
    • “Many of those younger adults are former athletes.”
  • The American Medical Association lets us know what doctors wish their patients knew about pink eye.
  • The Hill notes,
    • “Teen births declined 69 percent from 2000 to 2022, according to newly released federal data, but racial and ethnic disparities continue to exist.  
    • Births declined at similar rates across all races, but Black, Native American and Hispanic teenagers still had higher birth rates in 2022 than white, non-Hispanic teens, according to the data from the Centers for Disease Control and Prevention. 
  • U.S. News and World Report adds,
    • “For the first time in two decades, the infant mortality rate in the United States has risen, new government data shows.
    • “In a report released Thursday by the U.S. Centers for Disease Control and Prevention, researchers found that more than 20,500 babies died in 2022 before the age of 1. Overall, there were 5.6 infant deaths for every 1,000 live births, a 3% increase from the year before.
    • “Infant health is one of the most important public health indicators that we have,” Amanda Jean Stevenson, a demographer and assistant professor of sociology at the University of Colorado Boulder, told CNN.
    • “The fact that [infant mortality rates] are not continuing to decrease is a very big deal. Even flat infant mortality rates are not good,” she added. “We need to see these numbers going down — and fast — because they are far too high.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Hospitals are finally emerging from the pandemic’s lasting disruption to labor markets, adding nurses and other critical workers who left the market or job hopped for higher pay. 
    • “HCA Healthcare and Tenet Healthcare, two of the nation’s largest hospital and surgery-center companies, reported this week their hospitals are busy and are expected to stay that way through the year. Hiring has opened up services they had closed because of the pandemic and a tight labor market, company executives say.
    • “In totality, the strength in the hospital segment has been significant,” said Dr. Saum Sutaria, Tenet’s chief executive, on a call with analysts after the company posted its earnings this week. “We feel optimism about the demand that we see.”
  • In that regard, Healthcare Dive points out,
    • “Tenet Healthcare reported second-quarter earnings Wednesday that beat analysts’ estimates, drawing in a net income of $259 million on strong demand for outpatient services. 
    • “The Dallas-based provider raised its full-year guidance again following the results. Tenet was the only major for-profit provider to raise its full-year forecast following first-quarter earnings.
    • “Tenet now expects to bring in $3.8 billion to $4 billion in adjusted earnings before interest, taxes, depreciation and amortization — a $300 million increase over previous projections.” 
  • and
    • “Universal Health Services posted a second quarter net income of $289.2 million on Thursday and modestly revised its full-year revenue guidance up by 0.3% to 1%.
    • “However, CFO Steve Filton said on the company’s earnings call that acute care hospitals experienced a “moderation of demand” for services during the quarter, with adjusted admissions increasing 3.4% year over year and surgical growth “flattening out.” 
    • “The King of Prussia, Pennsylvania-based health system reported progress on controlling expenses — notably physician fee costs, which have plagued the system for multiple quarters. Executives called further cost controls critical to UHS’ efforts to get back to pre-pandemic operating margins.”
  • Per Beckers Hospital Review,
    • “St. Louis-based Ascension has taken another step in its effort to reorganize its portfolio — a strategy designed to enhance operating performance and ensure sustainability.
    • “The latest transaction is in the Midwest. Ontario, Calif.-based Prime Healthcare has entered into an asset purchase agreement with Ascension to acquire hospitals and care sites in Illinois.”
  • and
    • “Optum is closing clinics in multiple states and laying off 524 employees across California.
    • “According to regulatory documents filed July 18, the UnitedHealth Group company will terminate the California employees from Sept. 16 through January 2025 at clinic and administrative office locations in Hayward, Glendora, Montbello, Covina, Pasadena, Long Beach, Los Angeles, Irvine, Beaumont, Redlands, Highland, El Segundo, and Cerritos. The layoffs include some remote employees in other states.”
  • Healthcare Dive further notes,
    • “Investors came into second-quarter earnings for Molina concerned about how challenges in its core Medicaid business might affect the insurer. However, Molina exceeded Wall Street’s expectations for earnings and revenue in finances released aftermarket Wednesday.
    • “Molina reported revenue of $9.9 billion, up almost 19% year over year thanks to the insurer winning new Medicaid contracts and growing its existing businesses. Net income of $301 million was down slightly year over year due to an increase in spending on Medicaid beneficiaries, but still better than analyst forecasts.
    • “Medicaid pressures should ameliorate over the back half of the year, Molina executives told investors on a Thursday morning call. Molina is also open to additional M&A, despite coming off two recent acquisitions, and plans to stand up a new business to oversee its growth strategy in dual-eligible Medicare and Medicaid plans.”
  • Per Beckers Payer Issues,
    • “CareFirst Blue Cross Blue Shield credits a critical partnership with achieving top-tier results for Type 2 diabetes care. 
    • “CareFirst partnered with Ryse Health, a chain of clinics in the Washington, D.C. and Baltimore areas, focused exclusively on managing diabetes. CareFirst members who received care at Ryse Health clinics had, on average, scores in the 95th percentile for several HEDIS measures.
  • and
    • “UnitedHealth Group will invest $25 million for housing for veterans experiencing homelessness and low and middle-income individuals. 
    • “The grant will go to the Community Solutions Large Cities Housing Fund, a $135 million fund backed by Kaiser Permanente, Wells Fargo and other large donors. The fund directly acquires apartment units. Half of these units are reserved for individuals transitioning out of homelessness, including veterans, according to a July 24 news release.” 
  • Per BioPharma Dive,
    • “Viking Therapeutics shares soared by more than 30% early Thursday after the company told investors it’s moving an experimental obesity drug into Phase 3 testing earlier than expected and exploring more convenient dosing.
    • “The medicine, dubbed VK2735, has already shown promising results in a Phase 2 trial released in February. In that study, patients lost as much as 15% of their body weight after 13 weeks of treatment with the drug, findings that suggest Viking’s option might be a future threat to blockbuster obesity medications sold by Novo Nordisk and Eli Lilly.
    • “Analysts expected the next step would be a Phase 2b trial. But late Wednesday, Viking said it’s moving directly to Phase 3 after a meeting with Food and Drug Administration officials. The company also plans to study monthly injections for the medicine, potentially offering another advantage over the once-weekly products available now.”
  • and
    • “Roche is best known for the cancer drugs that still account for much of its drug revenue. But the Swiss pharmaceutical giant spent much of its latest quarterly earnings call fielding questions about a pair of experimental weight loss medicines that have fast become important to its future growth.
    • “Roche last year acquired those medicines in a $2.7 billion deal for biotechnology company Carmot Therapeutics. One, CT-388, is an injectable therapy, while the other, CT-996, is a pill. Since May, both have since shown the potential in early trials to spur significant weight loss, adding billions to Roche’s market value and making the company a surprise player in one of the most lucrative areas of drug research.
    • “It’s going to be a huge market,” CEO Thomas Schinecker said on a conference call. “By 2035, about 50% of the world’s population will be obese.”


Midweek update

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • At long last, the federal employee press is publicizing the Part D opt out penalty found in the proposed supplemental Postal Service Health Benefits (PSHB) Program rule.
  • Federal News Network reports, “There’s a catch in USPS insurance program for Medicare-eligible retirees. USPS annuitants who opt out of Medicare Part D will lose underlying prescription drug coverage, according to OPM’s [proposed] regulations.” Those opt out annuitants will continue to pay the full premium.
  • OPM reads the PSHB law as only offering Part D EGWP benefits to Part D eligible annuitants in the PSHBP. There is no underlying Rx coverage according to the agency’s FAQs. That statutory interpretation puts federal employees who live overseas in quite a pickle because Part D coverage is not available outside the United States.
  • In any case, it’s the FEHBlog’s legal opinion that the opt out penalty may not survive judicial review in our post-Chevron era, and because the penalty is roughly 20% of the premium, annuitants may be incented to bring a lawsuit challenging the penalty. Time will tell.
  • Govexec tells us,
    • “The Office of Personnel Management is opening a channel to provide federal employees affected by Hurricane Beryl to obtain emergency paid leave.  FEHBlog note: Beryl hit Houston TX hard.
    • “Acting OPM director Robert Shriver said in a July 19 memo that the agency had established an emergency leave transfer program, by which other federal employees may donate unused annual leave to impacted employees through the creation of agency leave banks. 
    • “Through the agency leave banks, impacted employees “who are adversely affected by a major disaster or emergency, either directly or through adversely affected family members, and who need additional time off from work” can utilize donated leave without having to use their own.” 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) has released new data on risk adjustment payments for 2023.
    • “The agency said (PDF) insurers participating on the Affordable Care Act’s exchanges will pay $10.3 billion as part of the risk adjustment program. Risk adjustment state transfers as a percent of premiums declined from 2022, according to the report.
    • “This trend is likely driven by shifts in the risk pools, according to CMS, which are likely impacted by ongoing insurer expansion into new regions.”
  • The American Hospital Association News informs us,
    • “The Substance Abuse and Mental Health Services Administration July 24 announced it is awarding $45.1 million in grants toward various behavioral health initiatives. The funding includes $15.3 million specifically planned to support children through mental health services in schools, services for those who have experienced traumatic events, and services specific to those at risk for or with serious mental health conditions.” 
  • Roll Call reports,
    • “House leaders canceled votes scheduled for next week as the GOP majority struggles to pass its fiscal 2025 appropriations bills.
    • “The decision to scrap next week’s session came a day after Republican leaders had to yank the Energy-Water spending bill from the floor amid growing doubts they could muster enough votes to pass it with their razor-thin majority. * * *
    • “GOP leaders all week had been mulling the possibility of sending members home early rather than remain in session next week as previously scheduled. Speaker Mike Johnson, R-La., said Wednesday that the decision to cancel votes next week wasn’t a direct result of problems with the appropriations bills.
    • “It’s not related to that. We’ve had a tumultuous couple of weeks in American politics and everybody’s, to be honest, still tired from our convention, and it’s just a good time to give everybody time to go home to their districts and campaign a little bit. We’ll come back and regroup and continue to work on this.”
    • “Johnson also said funeral arrangements for Rep. Sheila Jackson Lee, D-Texas, who died last weekend after a battle with pancreatic cancer, would pose logistical challenges next week. Johnson said a lot of members would want to attend the events, to be held in Houston, which could keep members away from Washington for three days.”
  • Per a Senate press release,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and five senators today introduced a bill to apply criminal penalties to rogue insurance brokers who are changing Americans’ Affordable Care Act (ACA) marketplace plans without their knowledge or consent, and take other steps to strengthen consumer health insurance protections. * * *
    • “The one-pager is available here. A summary of the bill is available here. The bill text is available here.”

From the public health and medical research front

  • ABC News relates,
    • “So far, only 25 cases of West Nile virus have been reported in 14 states, according to data from the Centers for Disease Control and Prevention. This is lower than the 117 cases reported at the same time last year. * * *
    • “Mosquitoes typically become infected with the virus after feeding on infected birds and then spread it to humans and other animals, the federal health agency said. Cases typically begin rising in July and are highest in August and September, CDC data shows.
    • “The majority of people with the virus do not have symptoms, but about one in five will experience fever along with headaches, body aches, joint pain, diarrhea, vomiting or a rash. Most symptoms disappear but weakness and fatigue may last for weeks or months.
    • “About one in 150 will develop severe disease leading to encephalitis, which is inflammation of the brain, or meningitis, which is inflammation of the membranes that surround the brain and spinal cord — both of which can lead to death. So far this year, 11 of the 25 cases have resulted in neuroinvasive disease, according to the CDC.
    • “There are currently no vaccines or specific treatments available for West Nile virus. The CDC recommends rest, fluids and over-the-counter medications. For those with severe illness, patients often need to be hospitalized and receive support treatments such as intravenous fluids.
    • “To best protect yourself, the CDC suggests using insect repellant, wearing long-sleeved shirts and pants, treating clothing and gear and taking steps to control mosquitoes. This last step includes putting screens on windows and doors, using air conditioning and emptying out containers with still water.”
  • The New York Times adds,
    • “As the bird flu outbreak in dairy cows has ballooned, officials have provided repeated reassurances: The virus typically causes mild illness in cows, they have said, and because it spreads primarily through milk, it can be curbed by taking extra precautions when moving cows and equipment.
    • “A new study, published in Nature on Tuesday, presents a more complex picture.
    • “Some farms have reported a significant spike in cow deaths, according to the paper, which investigated outbreaks on nine farms in four states. The virus, known as H5N1, was also present in more than 20 percent of nasal swabs collected from cows. And it spread widely to other species, infecting cats, raccoons and wild birds, which may have transported the virus to new locations.
    • “There’s probably multiple pathways of spread and dissemination of this virus,” said Diego Diel, a virologist at Cornell University and an author of the study. “I think it will be really difficult to control it at this point.” * * *
    • Although many infected cows did recover on their own, the researchers found, two farms reported a spike in cow deaths. On the Ohio farm, 99 cows died over the course of a three-week outbreak, a mortality rate roughly twice as high as normal.
    • “I think the potential for this virus to cause very serious disease has been downplayed a bit,” said Richard Webby, an influenza expert at St. Jude Children’s Research Hospital, who was not involved in the new study. “That has probably hurt the response.”
    • “Still, Dr. Diel noted, the cause of these deaths remains unknown. “Whether the mortality observed in those cases was due directly to influenza or whether the influenza infection led to a secondary bacterial infection, I think that’s a question that remains to be answered,” he said.”
  • Per BioPharma Dive,
    • “An experimental gene therapy from Pfizer succeeded in a Phase 3 study of people with hemophilia A, overcoming safety concerns that had put the trial on hold for almost a year.
    • “The treatment, giroctocogene fitelparvovec, is a one-time infusion designed to help patients produce a protein called Factor VIII that’s needed for normal blood clotting. Currently, people with hemophilia A use infusions of Factor VIII to prevent bleeding episodes.
    • “In the AFFINE study, researchers followed 75 patients for at least 15 months after they received Pfizer’s therapy. Study participants had fewer bleeding episodes and higher levels of Factor VIII, compared with standard prophylactic treatment before the infusion, Pfizer said Wednesday. Only one treated patient returned to prophylactic infusions.”
  • Healio notes that “In a single-center cohort of patients with heart failure and obesity, weight-loss surgery led to improved clinical outcomes including reduced BMI and HbA1c and less reliance on diuretics, researchers reported.”
  • mHealth Intelligence reports,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Humana’s CenterWell is planning to open 23 clinics at Walmart locations in four states, the company announced Wednesday.
    • “The health clinics will operate in space that previously held Walmart’s own clinics, according to the announcement. CenterWell intends to have the locations across Florida, Georgia, Missouri and Texas fully equipped, staffed and opened by the first half of 2025.
    • “The locations will operate under both the CenterWell and Conviva brands, providing senior-focused primary care. CenterWell is the fastest-growing senior-focused primary care provider in the nation, Humana said.”
  • Per Healthcare Dive,
    • “S&P Global Ratings analysts have downgraded Walgreens Boot Alliance by two notches, to ‘BB’ from ‘BBB-’, which puts the drugstore company into speculative-grade territory.
    • ‘Analysts Diya Iyer and Hanna Zhang cited guidance for the year “notably below” their expectations, and said “material strategic changes, limited cash flow generation, and large maturities in coming years are key risks to the business.”
    • “The company is struggling in its retail business as well as its pharmacy operations, they said in a Friday client note. In the U.S., margins are taking a hit on the pharmacy side from reimbursement pressure and on the retail side from declining sales volume and higher shrink. They expect Walgreens’ S&P Global Ratings-adjusted EBITDA margin to decline more than 100 basis points this fiscal year, dipping below 5%, from 6% last year, though the company’s cost cuts will counter that somewhat.”
  • MedTech Dive points out the top five medtech deals in the first half of 2024.
  • Per HR Dive,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

    Tuesday Tidbits

    David Ermer–Congress, Electronic health records, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
    Photo by Patrick Fore on Unsplash

    From Washington, DC

    • Modern Healthcare reports,
      • “Lawmakers and executives from three major pharmacy benefit managers presented diametrically opposing views at a heated Capitol Hill hearing Tuesday, as major bills aimed at reining in the organizations remain stalled in Congress. 
      • “Members of the House Committee on Oversight and Accountability blamed the highly concentrated PBM industry for raising drug prices and running independent pharmacies out of business, while leaders from CVS Caremark, Express Scripts and Optum Rx all countered that the sector in fact lowers prices and supports local pharmacies.
      • “The hearing accompanied the committee’s release of a report detailing what its investigators characterized as abuses by the three large companies.”
    • Govexec lets us know,
      • “A federal employee group within the Justice Department last week made its final pitch to the federal government’s dedicated HR agency to boost the federal government’s coverage of in vitro fertilization and other assisted reproductive technology through the Federal Employees Health Benefits Program.
      • “The Department of Justice Gender Equality Network, an employee association representing nearly 2,000 workers at the Justice Department, sent acting Office of Personnel Management Director Rob Shriver three dozen testimonials from members describing the hardships they endured while trying to conceive. The move comes amid OPM’s final round of negotiations with insurance carriers over what FEHBP plans will cover next year.”
    • Federal News Network tells us,
      • “More than 15 years in the making, plans to update the federal pay system for blue-collar government employees are finally gaining some traction.
      • “A proposal to reform the Federal Wage System (FWS) has moved into the early stages of the government’s rulemaking process, the Federal Prevailing Rate Advisory Committee (FPRAC) announced during a public meeting Thursday morning.
      • “The proposal, if finalized, would amend the federal pay system for blue-collar government workers, more closely aligning it with the locality pay areas for the General Schedule (GS). An estimated 15,000 blue-collar feds would see their pay rates increase.”
    • Fierce Healthcare informs us,
      • “Walgreens has received $25 million in grant funding to conduct a decentralized clinical trial assessing how well a person vaccinated against COVID-19 is protected from future infections. 
      • “The award funding comes from a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), embedded in the U.S. Department of Health and Human Services. The partnership is BARDA’s first with a major retail pharmacy. Walgreens will conduct a phase IV observational clinical study, using COVID vaccine data, to assess correlates of protection, known as responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data.
      • “The initiative’s goal is to increase access to clinical trials. Currently, participants in a vaccine clinical trial often travel to hospitals, universities or other central locations that are far from their homes. Taking a decentralized approach through a geographically diverse retailer like Walgreens can help reach patients where they are and enable the collection of real-world data, the organizations said. The partners also hope that learning what aspects of decentralized clinical trials work for vaccine correlates of protection studies can help drive future studies at scale.”
    • The Office of National Coordinator for Health Information Technology issued a standards bulletin that is “a companion to the USCDI v5 standard document published in July 2024. This issue provides background of USCDI v5 and the new data classes and elements that support improved patient care and advance the Administration’s goals of equity, diversity, and access to health care.”
    • The Food and Drug Administration announced,
      • On Monday, [July 22,] the FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
      • “Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”
      • The most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. See full prescribing information for additional information on the safety and effectiveness of Femlyv.

    From the public health and medical research front,

    • The American Hospital Association News relates,
      • “The Department of Health and Human Services July 23 released an amendment to a 2013 emergency declaration under the Food, Drug and Cosmetic Act that broadens the scope in which the agency can help facilitate certain medical countermeasures in response to a public health emergency such as a pandemic. The amendment now applies to pandemic influenza A viruses and others with pandemic potential, such as the current H5N1 strain of bird flu that has infected cattle and subsequently humans in some states. Previously, the declaration specifically covered just the H7N9 strain of bird flu. The declaration would allow the Food and Drug Administration to extend the expiration date of certain medical products and allow HHS to issue an emergency use authorization for unapproved drugs, devices or products, among other actions.”
    • Per BioPharma Dive,
      • “An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded in a late-stage trial, the company said Tuesday.
      • “In a statement, Merck said the therapy, an antibody called clesrovimab, met its main safety and efficacy objectives in a placebo-controlled trial involving more than 3,600 healthy or preterm infants. Those goals included the incidence of RSV-associated lower respiratory infections requiring medical attention over the course of five months, compared to placebo, as well as the percentage of patients experiencing certain types of adverse events.
      • “A spokesperson told BioPharma Dive in an email that clesrovimab met a key secondary measure by reducing the risk of hospitalization from RSV in the trial. But the company didn’t provide specifics on that result or the rest of the study findings, which will be presented at a future medical meeting. In the meantime, Merck plans to share the data with global health authorities.”
    • Per National Institutes of Health press releases,
      • “Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
      • “Cisgender women experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during pregnancy and the postnatal period, and we need to offer them evidence-based options when they may need them most,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy.”
    • and
      • “A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive. The findings were presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
      • “We are still learning how to optimize the package of services that accompany long-acting PrEP, including HIV testing,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “The viral load testing findings observed in this study illuminate performance gaps in the current U.S. HIV testing algorithm for injectable cabotegravir PrEP.”
    • and
      • “Researchers at the National Institutes of Health (NIH) found that an artificial intelligence (AI) model solved medical quiz questions—designed to test health professionals’ ability to diagnose patients based on clinical images and a brief text summary—with high accuracy. However, physician-graders found the AI model made mistakes when describing images and explaining how its decision-making led to the correct answer. The findings, which shed light on AI’s potential in the clinical setting, were published in npj Digital Medicine.  The study was led by researchers from NIH’s National Library of Medicine (NLM) and Weill Cornell Medicine, New York City.
      • “Integration of AI into health care holds great promise as a tool to help medical professionals diagnose patients faster, allowing them to start treatment sooner,” said NLM Acting Director, Stephen Sherry, Ph.D. “However, as this study shows, AI is not advanced enough yet to replace human experience, which is crucial for accurate diagnosis.”
    • Per MedPage Today,
      • “Patients with dementia may instead have hepatic encephalopathy (HE) and should be screened with the Fibrosis-4 (FIB-4) index for cirrhosis, one of the main causes of the condition, new research suggests.
      • “The study of more than 68,000 individuals in the general population diagnosed with dementia between 2009 and 2019 found that almost 13% had FIB-4 scores indicative of cirrhosis and potential HE.
      • “The findings, recently published online in The American Journal of Medicine, corroborate and extend the researchers’ previous work, which showed that about 10% of US veterans with a dementia diagnosis may in fact have HE.”

    From the U.S. healthcare business front,

    • Healthcare Dive reports,
      • “HCA Healthcare reported second-quarter earnings that handily beat Wall Street expectations.
      • “The Nashville, Tennessee-based operator posted $17.5 billion in revenue, a net income of $1.5 billion and a 5.8% increase in same facility admissions. During a call Tuesday, HCA’s executive team attributed the company’s success to broad demand for services and an ability to manage expenses.
      • “HCA updated its full-year revenue guidance following the results. It now expects to draw between $69.8 billion and $71.8 billion, up from the originally forecast $67.8 billion to $70.3 billion.”
    • Modern Health points out,
      • “Molina Healthcare said Tuesday it is expanding into Connecticut through an agreement to acquire EmblemHealth subsidiary ConnectiCare Holding Co., for $350 million.
      • “The Farmington, Connecticut-based health insurer has approximately 140,000 members in marketplace, Medicare and other health insurance plans across the state, according to a news release. Molina said the purchase price represents a quarter of ConnectiCare’s $1.4 billion in expected 2024 revenue. The company said it will fund the deal with cash on hand and plans to close it in the first half of 2025.
      • “The ConnectiCare purchase is part of Long Beach, California-based Molina’s strategy to develop stable revenue streams and deploy capital more efficiently, President and CEO Joe Zubretsky said in the news release.
      • “The deal is Molina’s second acquisition this year. In January it completed the purchase of Bright Health Group’s California Medicare Advantage business for $425 million.”
    • Beckers Hospital Review identifies fifteen health systems that are dropping certain Medicare Advantage plans and notes,
      • Medicare Advantage accounted for around 1 in 4 inpatient hospitals days in 2022, according to a report from KFF published July 23.  * * *
      • In rural and micropolitan counties, the share of inpatient days from Medicare Advantage enrollees doubled between 2015 and 2022. 
      • Read more here. 
    • Behavioral Health Business discusses virtual applied behavioral therapy.
      • “It’s no secret that there is a steep supply-and-demand issue for applied behavior analysis (ABA) services nationwide. 
      • “The industry is relatively new, which means the pool of qualified professionals is still small compared to the need. There are less than70,000 board-certified behavior analysts in the U.S. Still, autism impacts 1 in 36 children, according to the CDC. 
      • “Many of those qualified clinicians are prioritizing flexibility in the workplace and turning to telehealth.”

    Monday Roundup

    David Ermer–ACA, CDC, CMS, Medical / Rx research, Medicare, Mental health care, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    From Washington, DC,

    • Healthcare Dive reports,
      • “The Biden administration is making it harder for insurance agents and brokers to change people’s plans on the federal Affordable Care Act marketplace following mounting consumer complaints about unauthorized changes.
      • “On Friday, the CMS announced agents can’t make changes to a consumer’s enrollment in the federal exchanges unless they’re already associated with that consumer. If agents and brokers are unassociated, they have to take additional steps to update a consumer’s marketplace enrollment — even with that consumer’s consent, according to the notice.
      • “Unassociated brokers will have to have a three-way call with the beneficiary and the marketplace’s call center, or have the beneficiary change their enrollment themselves through HealthCare.gov or another approved portal. The changes, which don’t apply to the 18 states (and Washington, D.C.) that run their own insurance marketplaces, took effect immediately.”
    • Per an HHS press release,
      • “The Biden-Harris Administration’s Kids Online Health and Safety Task Force, co-led by the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Commerce’s (DOC) National Telecommunications and Information Administration (NTIA), released a new report today with recommendations and best practices for safer social media and online platform use for youth. The recommendations in the report, Online Health and Safety for Children and Youth: Best Practices for Families and Guidance for Industry, underscore the Administration’s efforts to address the ongoing youth mental health crisis and support the President’s Unity Agenda for the nation. Task Force members also committed to future actions, including providing more resources for kids, teenagers and families, guidance for pediatricians and conducting more research.”
    • Healthcare Innovation lets us know,
      • “On July 17, the Office of the National Coordinator for Health IT (ONC) released the agency’s latest Data Brief and Quick Stat. According to ONC’s survey findings, 64 percent of U.S. hospitals plan to participate in TEFCA™, the Trusted Exchange Framework and Common Agreement. The agency notes that “This is an increase over 2022, when 51 percent of U.S. hospitals said they planned to participate.”
      • “Other findings:
        • “Approximately 7 out of 10 hospitals that participated in national networks or health information exchanges (HIEs) planned to participate in TEFCA, compared to 4 out of 10 hospitals that did not participate in either type of network.
        • “Hospitals with more resources, such as those that are larger, non-critical access, and affiliated with health systems, indicated greater awareness and had higher levels of planned participation in TEFCA when compared to smaller, critical access, and independent hospitals with fewer resources.
        • “The percent of hospitals that were aware of TEFCA but did not know if they would participate decreased from 23% to 9% from 2022 to 2023.”
      • FEHBlog Note — TEFCA is the government’s backbone for the healthcare electronic medical records system.

    From the public health and medical research front,

    • The Washington Post reports,
      • “More than 40 percent of women said they skipped or delayed a screening recommended by a health professional, according to a recent survey by Gallup for the medical technology company Hologic.
      • “In the survey of 4,001 adult women across the United States, 90 percent of respondents agreed that it is important to get regular preventive health screenings for cancer, heart disease, sexually transmitted infections and other key health conditions. But 43 percent also said they skipped or delayed a recommended screening, including for breast cancer, cervical cancer and colorectal cancer.
      • “The respondents cited multiple reasons for doing so: anxiety about medical tests, pain concerns, cost, lack of time or not believing a screening was necessary.
      • “In addition, only 42 percent of the participants said they were “very confident” about which health screenings they needed. Many women also had trouble finding pertinent information, with 31 percent of Gen Z women saying it was hard for them to find relevant health information.”
    • Medscape tells us,
      • “Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.
      • “A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.” * * *
      • “Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” said Millennium Health Chief Clinical Officer Angela Huskey, PharmD, in a press release.”

    From the U.S. healthcare business front,

    • Fierce Healthcare names the most influential minority executives in healthcare. Kudos to that group.
    • Beckers Payer Issues points out recent physician hires to executive roles at payer organizations.
    • Fierce Healthcare informs us,
      • “Embattled Steward Health Care has canceled auctions for its hospitals in Ohio and Pennsylvania after it did not receive qualified bids for those facilities, according to a court filing.
      • “The health system said in a document filed Sunday with bankruptcy court in Texas that it is working to determine alternatives for those facilities and expects to make an announcement at a later date. It had initially set a bid deadline for June 24 for these assets, which was later pushed back to July 15.
      • “Steward filed for chapter 11 bankruptcy in the Southern District of Texas in May.”
    • Fierce Healthcare also relates,
      • “Cigna has created a new impact fund that aims to address health disparities commonly impacting local communities.
      • “The insurer’s philanthropic arm, the Cigna Group Foundation, will operate the Cigna Group Health Equity Impact Fund. Through the program, Cigna will contribute $9 million over the next three years to tackle disparities and inequities across priority states.
      • “According to an announcement, the program will initially focus in Houston, Texas and Hartford, Connecticut. By drilling down to these specific communities, Cigna said it can “optimize” the level of assistance needed to put toward the unique equity challenges they’re facing.”

    Weekend update

    David Ermer–CDC, Congress, Medicare, U.S. Healthcare–

    From Washington, DC,

    • The House Oversight and Accountability Committee will hold its third hearing on prescription benefit managers this Tuesday July 23 at 10 am.
    • Over the past two weeks —
      • Tammy Flanagan, writing in Govexec, offered tips on creating a smooth transition from federal employee to federal annuitant.
      • Kevin Moss, writing in the Federal Times, discusses the pros and cons of paying for both FEHB and Medicare Part B coverage. He summarizes as follows:
        • “The main reason to not consider enrolling in Part B is the cost of the extra premium. For federal annuitants that are not subject to IRMAA, adding Part B will most likely be worth it. Having Part B gives you the option to see doctors outside of the plan network and if you enroll in an FEHB plan that waives some out-of-pocket costs or consider MA plans offered by FEHB plans, you could see a reduction in your total healthcare spending.
        • “For federal annuitants that are subject to IRMAA, most of the benefits of enrolling in Part B will erode by having to pay more. This is especially true if your income places you in the second tier or higher of IRMAA and you expect that level of income throughout your retirement.”
      • The FEHBlog points out that the IRMAA tax is temporary because incomes usually subside in retirement below the IRMAA relatively high thresholds while the Medicare Part B late enrollment penalty is forever.

    From the public health and medical research front,

    • Fortune Well lets us know,
      • “As U.S. health officials investigate a fatal outbreak of listeria food poisoning, they’re advising people who are pregnant, elderly or have compromised immune systems to avoid eating sliced deli meat unless it’s recooked at home to be steaming hot.”
      • “The U.S. Centers for Disease Control and Prevention didn’t mandate a food recall as of early Saturday, because it remains unclear what specific products have been contaminated with the bacteria now blamed for two deaths and 28 hospitalizations across 12 states. This means the contaminated food may still be in circulation, and consumers should consider their personal risk level when consuming deli meats.
      • “Federal health officials warned on Friday that the number of illnesses is likely an undercount, because people who recover at home aren’t likely to be tested. For the same reason, the outbreak may have spread wider than the states where listeria infections have been reported, mostly in the Midwest and along the U.S. eastern coast.
      • “The largest number known to get sick — seven — were in New York, according to the CDC. The people who died were from Illinois and New Jersey.
      • “Of the people investigators have been able to interview, “89% reported eating meats sliced at a deli, most commonly deli-sliced turkey, liverwurst, and ham. Meats were sliced at a variety of supermarket and grocery store delis,” the CDC said.”
    • The Wall Street Journal reports,
      • “How much drinking is bad for you?
      • “Though more people are calling themselves sober-curious or are trying zero-proof replacements for alcohol, drinking is a regular part of social life for most of us. A coupe of champagne can add fun to a celebration. A cocktail can take the edge off a tough day. And a cold beer can liven up a sports game. 
      • “Yet scientists’ warnings about the potential health problems of even small amounts of alcohol are growing more dire. For moderate drinkers, it can be hard to know what’s actually OK to consume: Is two a day that much worse than one? Are two drinks over a week the same as two in a day? 
      • “Averaging no more than about one drink a day is relatively low risk, according to scientists who study alcohol. They warn the risk of cancer rises significantly when you exceed that. Studies have suggested that alcohol contributes to about half a dozen types of cancers, including breast and colorectal, as well as heart and liver disease, among other conditions.” 
    • MedPage Today reports,
      • “U.S. health officials on Friday said a new study in Michigan suggested the bird flu virus is not causing asymptomatic infections in people, while also announcing two new human cases in Colorado.
      • “Last month, the Michigan Department of Health and Human Services launched a study of workers who were around cows sickened by the bird flu. The researchers drew blood from 35 people.
      • “One goal was to determine if there were people who never had any symptoms but did have evidence of past infections. None of the blood testing showed antibodies that would indicate infections with the highly pathogenic avian influenza (HPAI) A(H5N1) virus circulating among dairy cattle and poultry, the CDC reported on Friday.
      • “The lack of antibodies to avian influenza A(H5N1) virus suggests these people were not previously infected with an avian influenza A(H5N1) influenza virus,” the agency said. “These data are consistent with other dataopens in a new tab or window demonstrating the seroprevalence to HPAI A(H5N1), even among workers with known exposures, is low.”
      • “Many of the workers did show antibodies to seasonal flu, which was used as a control virus in the study. Researchers will continue to sample workers, and the data will be analyzed and prepared for a peer-reviewed publication, the CDC said.
    • Per Medscape,
      • “One in five children (20.2%) who have an older sibling with autism spectrum disorder (ASD) are likely to be diagnosed with the disorder as well, according to a study published in Pediatrics.
      • “When a baby had more than one older sibling with autism, the family recurrence rate rose to 36.9%, the study found. * * *
      • “Dr Ozonoff’s team found that sex and race played a part in likelihood of recurrence. Younger siblings of females with ASD were much more likely to develop the disorder (34.7%) than siblings of boys (22.5%). And male younger siblings were more likely to have ASD than girls (25.3% vs 13.1%).”

    Cybersecurity Saturday

    David Ermer–Cybersecurity–
    • The Wall Street Journal reports,
      • “Hemant Rathod, an Indian executive, was sipping tea in a conference room Friday morning in Delhi, about to send a long email to his team, when his computer went haywire.
      • “The HP laptop suddenly said it needed to restart. Then the screen turned blue. He tried in vain to reboot. Within 10 minutes, the screens of three other colleagues in the room turned blue too.
      • “I had taken so much time to draft that email,” Rathod, a senior vice president at Pidilite Industries, a construction-materials company, said by phone half a day later, still carrying his dead laptop with him. “I really hope it’s still there so I don’t have to write it again.”
      • “The outage, one of the most momentous in recent memory, crippled computers worldwide and drove home the brittleness of the interlaced global software systems that we rely on.  * * *
      • “Adding to the chaos—and further underlining the vulnerability of the global IT system—a separate problem hit Microsoft’s Azure cloud computing system on Thursday shortly before the CrowdStrike glitch, causing an outage for customers including some U.S. airlines and users of Xbox and Microsoft 365.
      • The CrowdStrike problem laid bare the risks of a world in which IT systems are increasingly intertwined and dependent on myriad software companies—many not household names. That can cause huge problems when their technology malfunctions or is compromised. The software operates on our laptops and within corporate IT setups, where, unknown to most users, they are automatically updated for enhancements or new security protections.
    • The irony lies in the fact that
      • “The global outage began with an update of a so-called “channel file,” a file containing data that helps CrowdStrike’s software neutralize cyber threats, CrowdStrike said. The update was timestamped 4:09 a.m. UTC—just after midnight in New York and around 9:30 a.m. in India.
      • “That update caused CrowdStrike’s software to crash the brains of the Windows operating system, known as the kernel. Restarting the computer simply caused it to crash again, meaning that many users had to surgically remove the offending file from each affected computer.”

    From the cybersecurity policy front,

    • Cybersecurity Dive informs us,
      • “A U.S. District Court judge dismissed most of the charges in a civil fraud case filed against SolarWinds by the Securities and Exchange Commission Thursday.
      • “The SEC filed suit in October alleging SolarWinds misled investors about the company’s cybersecurity practices leading up to the Sunburst supply chain hack, which was disclosed in December 2020. The attack that targeted SolarWinds Orion platform impacted thousands of customers, including major U.S. companies and government agencies that used the platform. 
      • “Judge Paul Engelmayer of the U.S. District Court Southern District of New York sustained the SEC’s claims of securities fraud based on SolarWinds’ security statement. However, the court dismissed other claims, including all claims involving post-Sunburst disclosures. * * *
      • “Allegations related to a 2017 statement made about the company’s security capabilities on the “trust center” page of its website will continue to be litigated.” 
    • The Wall Street Journal points out,
      • “A spokesman said SolarWinds is pleased with the judge’s ruling. “We look forward to the next stage, where we will have the opportunity for the first time to present our own evidence and to demonstrate why the remaining claim is factually inaccurate,” he said. * * *
      • “David Shargel, a partner at law firm Bracewell, said the dismissal of part of the SEC’s claims was a victory for SolarWinds “by any measure.” Companies rarely defeat the SEC’s lawsuits so early in the litigation process.”
      • “It’s definitely a serious charge that remains, and it serves as a reminder that, as with any public-facing statement, companies need to ensure that their disclosures are accurate and not misleading,” he said.” * * *
      • Notably, Engelmayer also dismissed the SEC’s claim that SolarWinds violated rules that govern how companies guard against accounting errors. The judge said cybersecurity controls aren’t part of that process. “That reading is not tenable,” the judge wrote, saying the controls clearly apply only to financial accounting. 
      • “I think that might give some compliance departments some comfort going forward in terms of the parameters of the disclosure requirements,” Shargel said.
    • The National Institute of Standards and Technology issued a special publication concerning Personal Identity Verification (PIV). Experience-rated FEHB carriers must employ PIV for their employees who access OPM’s letter of credit system.

    From the cybersecurity vulnerabilities and breaches front,

    • Security Week informs us that “The massive AT&T breach has been linked to an American hacker living in Turkey and reports say the telecom giant paid a $370,000 ransom.”
    • Cybersecurity Dive lets us know,
      • “Weak credentials and misconfigurations across cloud systems were at the root of 3 in 4 network intrusions during the first half of 2024, Google Cloud said Wednesday in its latest Threat Horizons Report.
      • “Google Cloud said systems with weak or no credentials were the top initial access vector, accounting for 47% of cloud environment attacks during the first six months of the year. That’s a slight decrease from the second half of 2023 when weak or no credentials were at the root of 51% of attacks, according to Google Cloud.
      • “Misconfigurations were the initial access vector for 30% of all cloud environment attacks during the first half of 2024, marking a significant jump from 17% in the second half of 2023.”
    • The Cybersecurity and Infrastructure Security Agency added four known exploited vulnerabilities to its catalog this week:

    From the ransomware front,

    • Per Cybersecurity Dive,
      • “Ransomware activity jumped in the second quarter as threat groups listed 1,237 organizations on data leak sites during the period, marking a 20% increase from Q1, Reliaquest said in a Tuesday report. 
      • “May was an especially active month due to a spike in posts from the ransomware group LockBit, which accounted for 36% of the month’s alleged victims, the report found. Yet, an abnormally slow June dragged the total count of alleged ransomware victims down 13% year over year, according to Reliaquest.
      • “U.S.-based businesses bore the brunt of ransomware attacks during Q2, composing more than half of all claimed ransomware victims listed on data leak sites during the period. Sectors targeted most heavily by cybercriminals during the quarter included manufacturing and professional, scientific and technical services, the report found.”
    • The Wall Street Journal notes,
      • “Rite Aid disclosed customer data was accessed in a June cybersecurity breach.
      • “The drugstore operator said an unknown third-party impersonated a company employee on June 6. It detected the incident within 12 hours and launched an investigation and reported it to law enforcement.
      • “Rite Aid said by June 17 it determined the party acquired certain data associated with the purchase or attempted purchase of specific retail products, including purchaser name, address, date of birth and driver’s license number or other form of government-issued ID presented at purchase between June 6, 2017, and July 30, 2018.”
    • Dark Reading adds on July 15,
      • “[Rite Aid] has not released an official statement revealing who the threat actors are, but the RansomHub gang has claimed that it breached the company’s systems.
      • “While having access to the Rite-Aid network, we obtained over 10GB of customer information equating to around 45 million lines of people’s personal information,” the ransomware group said on its Dark Web leak site. “This information includes name, address, dl_id number, DoB, Rite Aid rewards number.”
      • “Rite Aid reportedly stopped negotiating a ransom, prompting the ransomware group to share snippets of what it claims is stolen data as proof and add a two-week deadline before more information will be leaked.”

    From the cybersecurity defenses front,

    • The Wall Street Journal reports,
      • “Google parent Alphabet is in advanced talks to acquire cybersecurity startup Wiz for roughly $23 billion, according to people familiar with the matter, in what would be its largest acquisition ever. 
      • “A deal could come together soon, assuming the talks don’t fall apart, the people said. 
      • “Alphabet is eyeing the deal at a time of intense antitrust scrutiny of the search company and other tech giants. The acquisition could also help boost Alphabet’s efforts in cloud computing, an important and growing business but one where it has lagged behind peers. * * *
      • “Google has been working to bulk up its cybersecurity business, focused on the cloud. Its biggest recent acquisition—and second largest ever—is the nearly $5.4 billion purchase two years ago of another security company, Mandiant.” 
    • TechTarget shares “best practices for protection from ransomware in cloud storage” and advises “CISOs on how to improve cyberthreat intelligence programs.”
    • Dark Reading explains why “In Cybersecurity, Mitigating Human Risk Goes Far Beyond Training.”

    Friday Factoids

    David Ermer–CDC, COVID-19, Cybersecurity, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–

    From Washington, DC,

    • Govexec reports,
      • “The Office of Personnel Management on Thursday encouraged federal agencies to conduct their own analyses to correct potential pay disparities within their workforces.
      • “In 2021, President Biden signed a sweeping executive order aimed at improving diversity, equity, inclusion and accessibility at federal agencies, including provisions requiring the creation of a governmentwide strategic plan on the issue and that the OPM director consider banning the use of past salary history to set pay during the hiring process. OPM followed through on that edict earlier this year.
      • “In a memo to agency heads Tuesday, acting OPM Director Ron Shriver highlighted OPM’s governmentwide study of pay gaps in the federal workforce, which found that in 2022, the gender pay gap was 5.6%, meaning women on average earned about 94 cents for every dollar male federal workers earned. The figure marks a slight improvement over the 2021 gender pay gap of 5.9% and is significantly better than the nationwide gender pay disparity of 16%.
      • “Shriver directed that federal agencies that operate their own pay systems governing at least 100 employees must now conduct the same review of pay policies that OPM did for the General Schedule, Federal Wage System and Senior Executive Service workforces. And he encouraged all agencies to conduct their own gap analyses to search for pay disparities along gender or racial and ethnic lines affecting their own workforces, regardless of pay system.”
    • HHS’s Administration for Strategic Preparedness and Response announced,
      • “awards totaling $18.5 million to two U.S. companies to expand the nation’s manufacturing of key starting materials and active pharmaceutical ingredients needed to make essential medicines. The awards are the first through ASPR’s BioMaP-Consortium, a public-private partnership established in January 2024.
      • “ASPR is committed to expanding our nation’s domestic manufacturing infrastructure,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “Today’s announcement advances our efforts to build resilient U.S.-based supply chains for pharmaceutical ingredients and mitigate risk and reliance on foreign supplies. Having this capability in the U.S. is critical for our emergency preparedness.”
      • “California-based Antheia will receive approximately $11 million to support U.S.-based production of pharmaceutical ingredients, and Virginia-based Capra Biosciences will receive approximately $7.5 million to leverage its bioreactor platform to manufacture three active pharmaceutical ingredients.” 
    • Mercer Consulting projects that for 2025 the health flexible spending account contribution limit will increase by $100 from $3200 to $3300 and the carryover limit will increase from $640 to $660.”

    From the public health and medical research front,

    • The CDC tells us today
      • Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in many areas.
      • COVID-19
        • Many areas of the country are experiencing consistent increases in COVID-19 activity. COVID-19 test positivity, emergency department visits, and rates of COVID-19–associated hospitalizations are increasing, particularly among adults 65+. CDC will continue to closely monitor trends in COVID-19 activity.
      • Influenza
      • RSV
        • Nationally, RSV activity remains low.
      • Vaccination
    • The University of Minnesota’s CIDRAP notes,
      • Along with the CDC’s report of high wastewater levels of SARS-CoV-2, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, notes that detections are in the high category, with no significant trend up or downward over the past 3 weeks. It said all regions of the country are in the high category, except for the Midwest, which is at the medium level.
    • STAT News adds,
      • “STAT spoke with experts in infectious disease, virology, and public health to find out what people need to know about this summer’s Covid surge.
      • “One key message: Despite the increase in cases, the protection people have built up thanks to rounds of vaccination and prior infections is still sparing the vast majority of people from severe illness.”
      • “Once you really get a decent immunity, you may get the virus again, but you’re probably not going to get very sick from it,” said Aaron Glatt, chair and professor of medicine at Mount Sinai South Nassau.”

    From the U.S. healthcare business front,

    • The American Hospital Association News lets us know,
      • “A non-malicious global technology outage that began in the early morning of July 19 is continuing to affect many industries and is having varying effects on hospitals and health systems across the country. The outage was caused by a faulty software update issued by the cybersecurity firm CrowdStrike, which is widely used by businesses and government agencies that run on Microsoft computers. 
      • “CrowdStrike is actively working with customers impacted by a defect found in a single content update for Windows hosts,” the organization posted on its website early today. “Mac and Linux hosts are not impacted. This is not a security incident or cyberattack. The issue has been identified, isolated and a fix has been deployed. We refer customers to the support portal for the latest updates and will continue to provide complete and continuous updates on our website. We further recommend organizations ensure they’re communicating with CrowdStrike representatives through official channels.
      • “CrowdStrike’s webpage includes more information about the issue and workaround steps organizations can take. The Cybersecurity and Infrastructure Security Agency also posted an alert on the incident.” 
    • The Hill reports,
      • “After peaking during the COVID-19 pandemic, physician burnout has dipped under 50 percent for the first time in four years, but doctors say working conditions in the medical field remain far from ideal. 
      • “A survey published by the American Medical Association (AMA) this month found that 48.2 percent of physicians in 2023 experienced at least one symptom of burnout, down nearly 15 percent from when this metric peaked in 2021. 
      • “Reported job satisfaction rose from 68 percent to 72.1 percent between 2022 and 2023, while job stress dropped in the same time frame, going from 55.6 percent to 50.7 percent. 
      • “It’s good news and it’s bad news,” Steven Furr, president of the American Academy of Family Physicians, told The Hill. “It’s good news that the numbers have gone down but still they’re higher than what we’d like them to be.” 
      • “The AMA has tracked physician burnout rates since 2011 along with the Mayo Clinic and Stanford Medicine. Prior to the pandemic, burnout rates ranged from 43.9 percent in 2017 to 54.4 percent in 2014.” 
    • mHealth Intelligence points out,
      • “Telehealth visits at United States hospitals skyrocketed during the COVID-19 pandemic, rising 75 percent between 2017 and 2021; however, adoption was uneven, with hospitals citing challenges to electronic health information exchange, according to a new study.
      • “Published in the Journal of General Internal Medicine, the study examined US hospitals’ adoption of telehealth before and during the pandemic, aiming to provide targeted policy implications.” * * *
      • “The researchers found that telehealth encounters increased from 111.4 million in 2020 to 194.4 million in 2021, a 75 percent jump. Additionally, hospitals offering at least one form of telehealth increased from 46 percent in 2017 to 72 percent in 2021.
      • “However, the adoption was not uniform across hospitals. Larger, nonprofit, and teaching hospitals were more likely to adopt telehealth than their counterparts. Notably, the study found no significant telehealth adoption disparities between hospitals in urban and rural areas.
      • “Further, more than 90 percent of hospitals allowed patients to view and download medical records, but only 41 percent permitted online data submission. One-quarter (25 percent) of hospitals identified certified health IT developers, such as EHR vendors, as frequent culprits in information blocking.
      • “Most US hospitals also reported challenges in exchanging health information electronically, with 85 percent citing barriers related to vendor interoperability.
      • “The researchers concluded that comprehensive policy interventions are necessary to address telehealth adoption and other IT-related disparities across the US healthcare system.”

    Thursday Miscellany

    David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Telehealth, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From Washington, DC,

    • Modern Healthcare reports,
      • “A powerful Senate committee plans to commence a bipartisan investigation into the Steward Health Care meltdown next week.
      • “The Senate, Health, Education, Labor and Pensions Committee will convene next Thursday for a vote to officially kick off a probe into the insolvent Dallas-based health system. Steward Health Care Chair and CEO Dr. Ralph de la Torre will be subpoenaed to testify at a hearing Sept. 12, HELP Committee Chair Bernie Sanders (I-Vt.) and ranking member Dr. Bill Cassidy (R-La.) said in a news release Thursday.
      • “Given the serious harm and uncertainty Steward’s bankruptcy and financial arrangements are having on hospitals, patients and healthcare workers throughout the country, Dr. de la Torre has given us no choice but to compel him to testify at this hearing,” Sanders and Cassidy said.
      • “De la Torre declined to attend a HELP Committee hearing last month and a subcommittee session in April.
      • “We have a number of questions to ask Dr. de la Torre about the bankruptcy of Steward Health Care and the financial arrangements leading up to its insolvency. It is time for Dr. de la Torre to answer them before Congress and the American people,” Sanders and Cassidy said.
    • Federal News Network informs us,
      • “The Office of Personnel Management will soon be reopening enrollments into the government’s Flexible Spending Account program, FSAFEDS.
      • “OPM previously suspended all new enrollments in the program after a recent surge in fraudulent activity that impacted hundreds of federal employees with Flexible Spending Accounts. OPM’s inspector general said the suspension came “out of an abundance of caution,” and to try to prevent further fraud in the program.
      • “Enrollments in FSAFEDS, including any enrollments based on Qualifying Life Events (QLEs), will reopen Aug. 1, OPM wrote in an email to agency benefit officers Thursday afternoon, shared with Federal News Network. Also beginning Aug. 1, the program will transition to a “.gov” website domain, FSAFEDS.gov, rather than the current domain, FSAFEDS.com.
      • “Enrollees who missed a QLE deadline due to the pause on enrollments should still be able to make modifications once the enrollment pause is lifted, OPM said. Employees who are in that situation will have to call FSAFEDS at 877-372-3337 to request a change to the effective date for the QLE.
      • “Additionally, federal employees will be able to get reimbursed for any claims that were incurred after the effective date for the QLE, OPM said.
      • “OPM is also taking more long-term steps to address security concerns in FSAFEDS, including transitioning to Login.gov, the government’s platform for accessing government benefits and services online.”
    • Per Govexec,
      • “The Office of Personnel Management wants federal agencies to let it know how many senior executives, scientific/professionals and other senior-level personnel they estimate they will need for the next two years.
      • “OPM outlined its biennial review of agency executive allocations in a July 10 memorandum, calling on agency and department heads to examine their potential Senior Executive Service needs through fiscal 2026 and 2027 and how they may have changed. 
      • “The biennial review, which is required by statute, will give agencies until Nov. 22 to fully outline their anticipated SES needs, but they must also detail the projections of their position needs in their Senior Level and Scientific/Professional pay systems by Aug. 23. 

    From the public health and medical research front,

    • Beckers Hospital Review tells us,
      • “The highest numbers of breast and cervical cancer deaths are found mostly in southeastern states, according to new data from the “2024 State Scorecard on Women’s Health and Reproductive Care” released July 18 by The Commonwealth Fund.
      • “The analysis is based on 2021-22 data from publicly available sources. Learn more about the methodology here.
      • “Alabama, Arkansas, Delaware, the District of Columbia, Indiana, Kentucky, Louisiana, Mississippi, Missouri, Nevada, Oklahoma, Tennessee and West Virginia had 23.2 to 27.8 breast and cervical cancer deaths per 100,000 female population, the highest numbers in the country.”
    • The NIH Director, in her weekly blog, lets us know,
      • “Alzheimer’s disease is currently the seventh leading cause of death in the U.S. While your likelihood of developing Alzheimer’s-related cognitive impairment increases with age, risk for this disease and age of its onset depend on many factors, including the genes you carry. An intriguing new study suggests that having just one copy of a protective gene variant may be enough to delay cognitive impairment from this devastating disease in individuals who are otherwise genetically predisposed to developing early-onset Alzheimer’s dementia.
      • “The findings, from a study supported in part by NIH and reported in The New England Journal of Medicine, offer important insights into the genetic factors and underlying pathways involved in Alzheimer’s dementia. While much more study is needed, the findings have potential implications for treatments that could one day work like this gene variant does to delay or perhaps even prevent Alzheimer’s dementia.”
    • The Washington Post reports,
      • “If you want to increase your odds of living a long and healthy life, watch less television and become more physically active, because even a small amount of physical activity can improve overall health, according to an observational study published last month in JAMA Network Open.
      • “While there have been many studies showing that moderate to vigorous physical activity is associated with healthy aging, researchers wanted to know if light physical activity compared with sedentary behaviors also improves healthy aging, and if not, how can people’s time be reallocated.
      • “They found that replacing a sedentary behavior such as watching TV with even low-intensity activity — such as standing or walking around while cooking or washing clothes — increased one’s odds of healthy aging. And at work, replacing some of the time spent sitting with simple movements such as standing or walking around the office can improve health.
      • “These findings indicate that physical activity need not be high intensity to potentially benefit various aspects of health, which have especially important public health implications as older people tend to have limited physical ability to engage in moderate-to-vigorous physical activity,” Molin Wang, an associate professor in epidemiology at the Harvard T.H. Chan School of Public Health and an author of the study, wrote in an email.”
    • Per Medscape,
      • “An analysis based on a massive database of US electronic health records (EHRs) adds to evidence favoring the safety of glucagon-like peptide 1 (GLP-1) medications, finding no increased risk for many neurologic and psychiatric ailments when semaglutide was compared with other diabetes drugs.
      • “Riccardo De Giorgi, MD, DPhil, of the University of Oxford, Oxford, England, and colleagues published their research in eClinicalMedicine.”
    • Bloomberg informs us,
      • “Opioids. They’re a public-health pariah, leading to more than 80,000 overdose deaths a year. Patients worry they’ll get addicted to them. Doctors want nothing to do with them. And politicians of all stripes are calling for less dangerous options for treating pain.
      • “We are looking for absolutely anything that’s not an opioid,” says Seth Waldman, an anesthesiologist and director of pain management at Hospital for Special Surgery, a top orthopedic medicine center.
      • “Against that backdrop, the success of a safer painkiller would seem assured. A new drug, which Vertex Pharmaceuticals Inc. is developing, has been hailed as a scientific breakthrough because it treats pain without entering the brain, where opioids create addicts. The drug, suzetrigine, met its goal this year in pivotal trials for acute pain and is poised to become the first new class of pain medication in more than two decades.
      • “But all that may not be enough to loosen the grip opioids have on American medicine. Despite their dismal reputation, they have two powerful things going for them: They’re cheap, and they work. The number of opioid prescriptions has been cut by half over the past decade, but some 130 million are still doled out each year.” * * *
      • “Vertex is betting the nonaddictive properties of its drug will make it an attractive alternative to opioids. But it isn’t leaving anything to chance. Knowing it faces an uphill battle commercially, the company last year boosted its lobbying spending almost 50%, to more than $3 million. Vertex is pressing Congress for new policies that remove “structural impediments” blocking access to opioid alternatives, says Stuart Arbuckle, its chief operating officer.
      • “Vertex has scored at least one legislative victory: The No Pain Act, which goes into effect next year, provides an extra Medicare reimbursement to hospitals that prescribe alternatives to opioids. Another bill introduced this year in Congress would prohibit step therapy and limit how much Medicare patients pay out of pocket for non-opioids.
      • “Other types of new drugs face this cost hurdle, too. The rollout of new contraceptives or antibiotics has been hampered by insurers guiding doctors and patients to older, less pricey meds. The difference is that those generics haven’t been declared a public-health emergency.”
    • Mercer Consulting points out “four things employers need to know about summer heat.”
    • The New York Times reports,
      • “A daily dose of a widely used antibiotic [doxycycline] can prevent some infections with syphilis, gonorrhea and chlamydia, potentially a new solution to the escalating crisis of sexually transmitted infections, scientists reported on Thursday.
      • “Their study was small and must be confirmed by more research. Scientists still have to resolve significant questions, including whether S.T.I.s might become resistant to the antibiotic and what effect it could have on healthy gut bacteria in people taking it every day.
      • “The approach would be recommended primarily to people at elevated risk of sexually transmitted infections during certain periods, said Dr. Jeffrey Klausner, an infectious diseases physician at the University of Southern California who was not involved in the new work.
      • “The number of people who are really going to be offered this and take this is still very small,” he said. “In general, the more choices we have for people, the more prevention options we have, the better.”

    From the U.S. healthcare business front,

    • Per Fierce Pharma,
      • “GoodRx is joining forces with drugmaker Boehringer Ingelheim to make its Humira biosimilar adalimumab available at an affordable price.
      • “The pharmaceutical company will offer citrate-free adalimumab-admb at a cash price available only on GoodRx, according to an announcement. This will allow anyone with a prescription to obtain the drug at one of 70,000 pharmacies nationwide, even if they’re uninsured.
      • “Beginning on July 18, Boehringer and GoodRx will offer high-concentration and low-concentration formulas of the drug in auto-injectors or pre-filled syringes at a price of $550 per two pack. The companies said that this is a 92% discount compared to a Humira prescription.”
    • Per Beckers Hospital Review,
      • “The FDA is allowing Mark Cuban Cost Plus Drug Co. to temporarily import a syphilis drug that has been in shortage for more than a year. 
      • “Penicillin G benzathine injection fell into low supply in April 2023, and since then, clinicians have been rationing the product. In January, the FDA issued a temporary authorization for French drugmaker Laboratoires Delbert to import penicillin G benzathine. 
      • “On July 17, the FDA updated its post on the drug’s shortage. To address the scarcity, the agency cleared Cost Plus Drugs to import the medication from Laboratórios Atral.
      • “The Portugal-based drug company will export two presentations of Lentocilin (benzathine benzylpenicillin tetrahydrate), according to FDA documents.
      • “Cost Plus Drugs is selling this medication to healthcare businesses for less than $15, the company said in July 17 post on X.” 
    • Segal Consulting relates,
      • “The average stop-loss coverage premium increase is 9.4 percent for the nearly 240 health plans in Segal’s 2024 national medical stop-loss dataset.”
      • “The average includes groups that increased specific stop-loss deductible levels and/or aggregating specific stop-loss deductibles resulting in an overall reduced rate action. The average premium increase for groups that maintained similar specific stop-loss benefit levels as the prior year is 11.5 percent.”
    • Per Fierce Healthcare,
      • “Telehealth giant Teladoc is partnering with startup Brightline to extend virtual mental healthcare services for children, adolescents and their families.
      • “Through the partnership, members under the age of 18 will have access to Brightline’s behavioral health solutions through Teladoc’s virtual “front door,” the companies said.
      • “The collaboration with Brightline builds on Teladoc’s existing mental health offerings and expands access to care to members of all ages, a Teladoc spokesperson said.”
    • Beckers Hospital Review identifies seven U.S. hospitals that have received brain tumor care certification by the Joint Commission.
      • Chippenham and Johnston-Willis Hospital, Richmond, VA
      • Hackensack (N.J.) University Medical Center Hackensack
      • Jewish Hospital, Cincinnati, OH
      • Pitt County Memorial Hospital, Greenville, N.C.
      • Santa Barbara (Calif.) Cottage Hospital
      • St. Vincent Hospital and Health Care Services, Indianapolis, IN
      • Texas Health Harris Methodist Hospital – Fort Worth, TX
    • Healthcare Dive lets us know,
      • “Humana has made a minority investment in Healthpilot, a company that aims to help beneficiaries choose Medicare plans, the insurer said Wednesday. Financial terms of the deal weren’t disclosed.
      • “Healthpilot uses an artificial intelligence model to recommend Medicare Advantage, Medicare supplement and prescription drug plans based on enrollee information.
      • “Healthpilot will continue to recommend plans options from other payers following the investment, Humana said in the release.