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 cybersecurity policy and law enforcement front,

  • Cyberscoop tells us,
    • “The White House is close to finalizing a second executive order on cybersecurity that covers a wide range of subjects for federal agencies to address, including artificial intelligence, secure software, cloud security, identity credentialing and post-quantum cryptography, according to sources familiar with work on the document.
    • ‘The executive order, a follow-up to the sweeping cybersecurity executive order President Joe Biden signed in his first year in office, had been working its way through the interagency process, during which agencies give feedback on the draft, sources said.
    • “According to one source familiar with the order, the interagency process has wrapped up and a draft is “95%” of the way toward its final incarnation. The target is to get something signed in early December, subject to the president’s review and approval. But another source recently told CyberScoop that the executive order is viewed as “pretty aspirational to get it done.”
  • and
    • “A coalition of influential infrastructure trade groups and associations want to change key definitions around an incoming cyber reporting mandate, citing long-standing “concerns” around the Cybersecurity and Infrastructure Security Agency’s engagement process and existing regulatory requirements.
    • “In a letter to CISA Director Jen Easterly this week, 21 organizations from the communications, energy, aviation, IT, and transportation sectors, among others, asked the cyber agency to start an “ex parte” process that would apply the critical infrastructure cyber reporting mandate “in a manner consistent with congressional intent.”
    • “Simply put, the public record to date is insufficient, and a single round of comments in response to CISA’s [Notice of Proposed Rulemaking] will not allow the agency to effectively capture and leverage stakeholder feedback,” the letter states. “Absent increased industry engagement, CISA’s proposed regulation may inadvertently impose requirements that hinder rather than help our sectors maintain security and operational efficiency.”
  • Per Fedscoop,
    • “A week before a deadline for federal agencies to submit to the White House their updated zero-trust implementation plans, a coalition of government IT leaders released a guide intended to strengthen data security practices.
    • “The 42-page Federal Zero Trust Data Security Guide, spearheaded by the Federal Chief Data Officers and Federal Chief Information Security Officers councils, zeroes in on “securing the data itself, rather than the perimeter protecting it,” part of what a Thursday press release termed “a foundational pillar of effective” zero-trust implementation.
    • “By Nov. 7, federal agencies must provide their updated plans for zero-trust implementation to the Office of the National Cyber Director and the Office of Management and Budget.
    • “This guide represents insights from agency practitioners who are in the trenches working to implement zero trust and secure their organization’s data,” Kirsten Dalboe, the Federal Energy Regulatory Commission’s CDO and chair of the CDO Council, said in a statement. “We’re building a cooperative relationship between data and cyber to tackle this government-wide challenge and ultimately ensure the public’s data is secured.” 
  • Per October 31, 2024, HHS press releases,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced a settlement with Plastic Surgery Associates of South Dakota in Sioux Falls, for several potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, following its investigation into a ransomware attack breach by OCR. Ransomware and hacking are the primary cyber-threats in health care.” * * *
    • “OCR initiated an investigation following the receipt of a breach report filed by Plastic Surgery Associates of South Dakota in July 2017, which reported that it discovered that nine workstations and two servers were infected with ransomware, affecting the protected health information of 10,229 individuals. The credentials the hacker(s) used to access Plastic Surgery Associates of South Dakota’s network were obtained through a brute force attack (hacking method that uses trial and error to guess passwords, login information, encryption keys, etc.) to their remote desktop protocol. After discovering the breach, Plastic Surgery Associates of South Dakota was unable to restore the affected servers from backup.
    • “OCR’s investigation revealed multiple potential violations of the HIPAA Security Rule, including failures to conduct a compliant risk analysis to determine the potential risks and vulnerabilities to ePHI in its systems; implement security measures sufficient to reduce the risks and vulnerabilities to ePHI to a reasonable and appropriate level; implement procedures to regularly review records of information system activity; and implement policies and procedures to address security incidents.” * * *
    • “Under the terms of the settlement, Plastic Surgery Associates of South Dakota paid $500,000 to OCR and agreed to implement a corrective action plan that requires them to take steps to resolve potential violations of the HIPAA Security Rule and protect the security of electronic protected health information.” * * *
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/psa-ra-cap/index.html .”
  • and
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Bryan County Ambulance Authority (BCAA), a provider of emergency medical services in Oklahoma for a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. The settlement resolves an investigation concerning a ransomware attack on BCAA’s information systems.” * * *
    • “In May 2022, OCR received a breach report concerning a ransomware incident that encrypted files on BCAA’s network. BCAA determined that the encrypted files affected the protected health information of 14,273 patients. OCR’s investigation determined that BCAA had failed to conduct a compliant risk analysis to determine the potential risks and vulnerabilities to ePHI in BCAA’s systems.
    • “Under the terms of the resolution agreement, BCAA agreed to pay $90,000 and to implement a corrective action plan that will be monitored by OCR for three years. Under the corrective action plan, BCAA will take a number of steps to ensure compliance with the HIPAA Security Rule and protect the security of ePHI * * * . * * *
    • “The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/bcaa-ra-cap/index.html .

From the cybersecurity vulnerabilities and breaches front,

  • Infor Security lets us know,
    • “Cybersecurity firm Sophos has detailed evolving tactics by Chinese advanced persistent threat (APT) groups following five years of collecting telemetry on campaigns targeting its customers.
    • “Working with other cybersecurity vendors, governments and law enforcement agencies, the researchers were able to attribute specific clusters of observed activity from December 2018 to November 2023 to the groups Volt Typhoon, APT31 and APT41/Winnti.
    • “A notable shift from widespread, indiscriminate attacks towards narrow targeting of high value organizations was observed over the period.
    • “Sophos assessed with high confidence that exploits developed by the threat actors were shared with multiple Chinese state-sponsored frontline groups, which have differing objectives, capabilities, and post-exploitation tooling.
    • ‘The analysis was conducted in response to calls from the UK’s National Cyber Security Centre (NCSC) and the US Cybersecurity and Infrastructure Security Agency (CISA) for technology developers to provide transparency around the scale of exploitation of edge network devices by state-sponsored adversaries.
    • “In the interests of our collective resilience, we encourage other vendors to follow our lead,” Sophos wrote in a blog dated October 31, 2024.”
  • Cybersecurity Dive alerts us on October 31,
    • “Fortinet alerted customers to four new indicators of compromise for a widely exploited zero-day vulnerability in its network and security management tool FortiManager in an updated security advisory on Wednesday.
    • “The cybersecurity vendor said the situation is evolving and the updates don’t reflect any major changes. “Since we worked with the hosting provider to take down the actor infrastructure, some IP IoCs have changed,” a Fortinet spokesperson said Wednesday in an email.
    • “Fortinet initially disclosed active exploitation of CVE-2024-47575, a missing authentication for critical function vulnerability which has a CVSS score of 9.8, last week. Mandiant said at least 50 organizations across various industries were impacted by a spree of attacks it described as a “mass exploitation” event.”
  • Cybersecurity Dive adds,
    • “Enterprise modernization initiatives are too often threatened by aging infrastructure and systems that have run out of technical support, according to a recent Kyndryl report. The IT services firm surveyed 3,200 C-suite executives and collected anonymized customer data from its Kyndryl Bridge platform.
    • “While 9 in 10 executives said their company’s technology is best-in-class, nearly two-thirds acknowledged that outdated systems present a major concern. Data indicating 44% of mission-critical enterprise IT infrastructure is approaching or at end-of-life confirmed the apparent paradox.
    • “If a company lacks comprehensive IT asset and configuration management, locating tech debt is a challenge, according to Michael Bradshaw, Kyndryl’s SVP and global practice leader for applications, data and AI. “It’s almost like an archaeological dig,” he said. “You don’t know where the problems are unless you stub your toe on something that’s reached end-of-support.”
  • CISA did not add known exploited vulnerabilities to its catalog this week.

From the ransomware front,

  • The American Hospital Association reports,
    • “The Cybersecurity and Infrastructure Security Agency Oct. 31 issued an alert on a large-scale spear-phishing campaign targeting organizations in several sectors. The agency received multiple reports on the matter. According to the agency, the foreign threat actor, often posing as a trusted entity, sends spear-phishing emails with malicious remote desktop protocol files to targeted organizations to connect to and access files stored on the target’s network. If the threat actor gains access, it could perform additional activities, such as deploying malicious code to achieve persistent access to the target’s network. CISA, other federal agencies and partners are coordinating and assessing the impact of the campaign and urged organizations to take proactive measures to protect their data and systems. 
    • “The malicious use of RDP to conduct cyberattacks, including highly disruptive ransomware attacks, continues to be a significant attack vector used by foreign cybercriminals, ransomware gangs and spies,” said John Riggi, AHA national advisor for cybersecurity and risk. “To help mitigate this type of cyberattack risk, it is strongly recommended health care organizations restrict outbound RDP connections, block RDP connections in communication platforms, prevent execution of RDP files and use phishing-resistant multi-factor authentication for all remote access. Please review the alert for additional recommendations.” 
  • Info Security reports,
    • “A North Korean-backed hacking group has engaged in a ransomware campaign for the first time, according to Palo Alto Networks.
    • “Jumpy Pisces, a hacking group tied to the Reconnaissance General Bureau of the Korean People’s Army, has been involved in a recent ransomware incident, according to a new report by Palo Alto’s threat intelligence team, Unit 42, published on October 30.
    • “This marks a shift in the nation-state group’s tactics and the first time they have been involved with financially motivated cyber threat actors.”

From the cyber defenses front,

  • Cybersecurity Dive relates
    • “UnitedHealth Group appointed Tim McKnight to CISO, marking a change in the company’s security leadership eight months after a ransomware attack on subsidiary Change Healthcare led to sustained nationwide disruptions. McKnight shared the news on LinkedIn this week. 
    • “McKnight replaces Steven Martin, who became CISO in May 2023, nine months before the ransomware attack. As part of the change, Martin shifted to a new role at UnitedHealth as chief restoration officer. Martin previously served as CIO and CTO at Change Healthcare and Optum, another subsidiary of UnitedHealth Group.
    • “Earlier this month, UnitedHealth Group confirmed the cyberattack, which involved compromised credentials to a remote access Citrix portal, compromised data on at least 100 million people, the largest healthcare data breach ever reported to federal regulators. The attack also hinged on a consequential mistake the healthcare giant made in failing to protect a critical system: it did not turn on multifactor authentication.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Factoids

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

From Washington, DC,

  • Lots of CMS announcements today.
    • Calendar Year (CY) 2025 Medicare Physician Fee Schedule Final Rule (Fact Sheet)
      • “By factors specified in law, average payment rates under the PFS will be reduced by 2.93% in CY 2025, compared to the average amount these services were paid for most of CY 2024. The change to the PFS conversion factor incorporates the 0% overall update required by statute, the expiration of the temporary 2.93% increase in payment for CY 2024 required by statute, and a relatively small estimated 0.02% adjustment necessary to account for changes in work relative value units (RVUs) for some services. This amounts to an estimated CY 2025 PFS conversion factor of $32.35, a decrease of $0.94 (or 2.83%) from the current CY 2024 conversion factor of $33.29.”
    • CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (Fact Sheet)
      • “In accordance with Medicare law, CMS is finalizing an update to OPPS payment rates of 2.9% for hospitals that meet applicable quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4% reduced by a 0.5 percentage point productivity adjustment.
      • “In the CY 2019 OPPS/ASC final rule with comment period, CMS finalized a proposal to apply the hospital market basket update to ASC payment system rates for an interim period of five years (CY 2019 through CY 2023). The CY 2024 OPPS/ASC final rule with comment period extended the interim period for an additional two years (through CY 2024 and CY 2025).
      • “Accordingly, using the hospital market basket update, CMS is finalizing an update factor to the ASC payment rates for CY 2025 of 2.9%. The update applies to ASCs meeting relevant quality reporting requirements. This update is based on the projected hospital market basket percentage increase of 3.4% reduced by a 0.5 percentage point productivity adjustment.”
    • Calendar Year 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (Fact Sheet)
      • “For CY 2025, CMS is increasing the ESRD PPS base rate to $273.82, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.7%. The CY 2025 ESRD PPS final rule also includes changes to the methodology for calculating the ESRD facility wage index, changes to the Low-Volume Payment Adjustment (LVPA) methodology, and several changes to the ESRD outlier policy.”
  • Per an October 30, 2024, CMS press release.
    • CMS updated the ‘Birthing-Friendly’ designation icons on Care Compare for the first time since rolling out the initiative in October 2023. Hospitals that attested to the Maternal Morbidity Structural measure in the Hospital Inpatient Quality Reporting Program received the designation. The icons will be refreshed using updated data from CY 2023. CMS created the designation to identify hospitals and health systems that participate in a statewide or national perinatal quality improvement collaborative program and that implement evidence-based care to improve maternal health. Eighty percent of pregnancy-related deaths are preventable, and Black, American Indian and Alaska Native, and Native Hawaiian and Pacific Islander people have the highest rates of pregnancy-related death. The ‘Birthing- Friendly’ designation is a step towards ensuring that all pregnant and post-partum people can find high-quality maternity care. 
  • Bloomberg adds,
    • The [Medicare physician fee schedule] rule quickly elicited calls for Congress to overhaul the way Medicare sets payment rates. Federal law requires that any payment increases be offset by equal cuts elsewhere in the program.
    • “To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” said a statement from Bruce A. Scott, president of the American Medical Association. 
    • “For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas,” Scott said.
  • and
    • “Overall Medicare payments to home health agencies will increase by 0.5%, or $85 million, next year under a final rule released Friday.
    • “The total amount reflects a 2025 payment increase of 2.7%, or $445 million, according to the rule (RIN 0938-AV28) from the Centers for Medicare & Medicaid Services. But that amount would be offset by an estimated 1.8% payment cut of $295 million as part of a “permanent behavior adjustment” based on the assumption that home health agencies altered their billing and coding activity to maximize reimbursements in previous years.
    • “The payment offsets are part of a CMS plan to use future rulemaking to recover billions of dollars in apparent overpayments.”
  • The American Hospital Association reminds us,
    • “Beginning Nov. 1 through Jan. 15, individuals and families can enroll in or change their health coverage options through the Health Insurance Marketplace. The Centers for Medicare & Medicaid Services expects that 97% of the website’s customers will have access to three or more insurance issuers and four in five can find coverage for $10 or less per month after subsidies. AHA’s #GetCovered page offers resources to help people choose the best coverage for themselves and their families.”  
       
  • Govexec reports that “Most TSP funds took a tumble in October. Only two portfolios in the federal government’s 401(k)-style retirement savings program ended last month in the black, ending a three-month run of gains.”
  • STAT News relates,
    • “The hospital industry has pushed back against Medicare payment reforms for years, arguing that the policies would financially hurt rural hospitals. 
    • “Two key senators on Friday released a plan to get around that issue by reinvesting some of the money saved from payment reforms to help rural and safety-net hospitals. Hospitals that keep providing services like trauma centers, labor and delivery units, and burn units would get financial bonuses, too. 
    • “The reforms, called “site-neutral” payments, would equalize Medicare payments for some services provided at hospital outpatient departments with what the program pays physician offices for the same services. The hospital industry at large has opposed the policy because it argues hospitals should get paid more because they have to provide round-the-clock care and have higher overhead costs. 
    • “Sen. Maggie Hassan (D-N.H.), who has led efforts on the issue, partnered on the policy proposals with Sen. Bill Cassidy (R-La.), who’s in line to lead the Senate’s health committee if Republicans take control of the chamber next year and sits on the committee that regulates Medicare payments. Hassan’s current GOP partner on a stalled site-neutral bill, Sen. Mike Braun (R-Ind.), is leaving the Senate at the end of this year.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • COVID-19 activity is declining in most areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southern and southeastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae have increased in the United States, especially in young children.
    • COVID-19
      • Nationally, COVID-19 activity has continued declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. National trends in growth of COVID-19 infections are uncertain overall. Decreases are predicted in some states, and slow growth is predicted from a low level in others.
      • The XEC variant is estimated to comprise 14-22% of circulating viruses as of October 26, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • Influenza
    • RSV
      • Nationally, RSV activity remains low. However, continuing signs of increased RSV activity have been detected in the southern and southeastern United States, particularly in young children. Emergency department visits and hospitalization rates are increasing in young children in some areas.
    • Vaccination
  • ABC News tells us,
    • “The total number of dengue fever cases in the U.S. is now more than double the number recorded all of last year, federal data shows.
    • “More than 6,800 cases of dengue have been reported nationally so far this year, according to data from the Centers for Disease Control and Prevention (CDC). Of those cases, more than 4,400 were locally acquired and more than 2,300 are travel associated.
    • “Locally acquired cases mean that those infected have no history of traveling to an area where dengue normally spreads, including tropical and subtropical areas of the world.
    • “The 6,800 figure is more than double the 3,352 dengue cases reported during all of 2023, CDC data shows.
    • “Currently, Puerto Rico makes up the bulk of cases this year with more than 4,200 reported there, according to CDC data. Earlier this year, the territory declared a public health emergency amid a rise in dengue case.”
  • The American Journal of Managed Care lets us know,
    • “Early smoking cessation post-cancer diagnosis significantly improves survival, with optimal benefits seen when quitting within 6 months.
    • “The Tobacco Research and Treatment Program at MD Anderson offers free, evidence-based cessation interventions, including counseling and pharmacotherapies.
    • “The study highlights a reduced mortality risk for patients who quit smoking by 3-, 6-, and 9-months post-treatment.
    • ‘Limitations include potential bias from self-reported abstinence and lack of data on noncancer health conditions.”
  • The University of Minnesota’s CIDRAP informs us,
    • “A multistate study of publicly insured children diagnosed as having pneumonia found that one in five did not receive antibiotics, researchers reported yesterday in JAMA Network Open.
    • “But while children who didn’t receive antibiotics had slightly higher rates of treatment failure than those who did, severe outcomes were rare regardless of antibiotic treatment, the researchers found.
    • “The study authors say their findings suggest future research should aim to identify children with pneumonia who can be safely managed without antibiotics.” 
  • STAT News reports,
    • “Novo Nordisk’s weight loss drug Wegovy helped people with a fatty liver disease called MASH experience improvements in liver scarring and achieve symptom resolution, results the company sees as supporting regulatory approval.
    • “After 72 weeks in a Phase 3 trial, 37% of patients on Wegovy experienced an improvement in liver scarring, or fibrosis, with no worsening of their disease. That compared with 23% of those on placebo, according to topline results Novo announced Friday.
    • “Additionally, 63% of people on Wegovy achieved resolution of their symptoms with no worsening of fibrosis, compared with 34% of participants on placebo.
    • “Novo said the results were statistically significant.
    • “GLP-1 drugs like Wegovy are increasingly being tested in a range of conditions beyond obesity, including diseases that affect the heart, kidneys, and liver. Wegovy is already approved to prevent cardiovascular complications, and for Novo, proving that the drug helps with even more complications may help it gain broader and more streamlined insurance coverage.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Tenet Healthcare posted $5.1 billion in revenue for the third quarter, exceeding analysts’ expectations as the provider’s hospital and ambulatory segments fielded higher-than-expected patient volumes.
    • “Business in Tenet’s ambulatory care service line was particularly strong, executives said during a Tuesday morning call with investors. Adjusted earnings before interest, taxes, depreciation and amortization for Tenet’s ambulatory surgery centers and surgical hospitals sat nearly 19% higher than this time last year at $439 million.
    • “Still, the company lowered the upper end of its 2024 revenue guidance to $20.6 billion to $20.8 billion, compared to prior guidance of $20.6 billion to $21 billion. Analysts from Leerink Partners said the revision was likely due to the performance of Tenet’s hospital portfolio and the timing of several hospital divestitures.”
  • Beckers Hospital Review points out,
    • “The University of Alabama at Birmingham Health System Authority has acquired Ascension St. Vincent’s Health System, effective Nov. 1. 
    • “Under the agreement, UAB Health System assumed ownership of all Ascension St. Vincent’s care sites, including the hospitals at Birmingham, Blount, Chilton, East and St. Clair, as well as the Trussville Freestanding Emergency Department, imaging centers and other clinics that are part of Ascension Medical Group. 
    • “The transaction was valued at $450 million.” 
  • Kaufmann Hall offers an infographic “reassessing retail health disruptors” one year later.

Happy Halloween

David Ermer–CMS, COVID-19, Electronic health records, FDA, Medical / Rx research, Medicare, NIH, Obesity, Telehealth, U.S. Healthcare–
Photo by Toa Heftiba on Unsplash

From Washington, DC,

  • Tammy Flanagan, writing in Govexec, answers Federal Benefits Open Season questions from readers.
  • Bloomberg reports,
    • “The [U.S. Court of Appeals for the] Third Circuit [sitting in Philadelphia] Wednesday wrestled with the constitutionality of a government drug price negotiation plan, hearing arguments from three drugmakers and the Biden administration over alleged industry harm and violations of property and speech. 
    • “Drugmakers Johnson & Johnson, Bristol-Myers Squibb Co., and AstraZeneca PLC took their challenge against the US government’s Medicare Drug Price Negotiation Program to the US Court of Appeals for the Third Circuit. The plan, created under President Joe Biden’s landmark Inflation Reduction Act, is part of the administration’s efforts to rein in high prescription drug costs by allowing the government to negotiate prices for certain drugs with manufacturers.” 
    • This is the first federal appellate court oral argument on this issue.

From the public health and medical research front,

  • Dr. Monica Bertagnollo, the NIH Director, writes in her blog,
    • “In 2021, NIH launched the Researching COVID to Enhance Recovery (RECOVER) Initiative , a nationwide research program, to fully understand, diagnose, and treat Long COVID. We continue to learn more about this condition, in which some people experience a variety of symptoms for weeks, months, or even years after infection with SARS-CoV-2, the virus that causes COVID-19. But we’re still working to understand the underlying reasons why people develop Long COVID, who is most likely to get it, and how best to treat or prevent it.
    • “Studies have shown that for some people, SARS-CoV-2 doesn’t completely clear out after acute infection. Scientists have observed signs that the virus may persist in various parts of the body, and many suspect that this lingering virus, or remnants consisting of SARS-CoV-2 protein, may be causing Long COVID symptoms in some individuals. Now, in a new study supported by RECOVER, scientists found that people with Long COVID were twice as likely to have these viral remnants in their blood as people with no lingering symptoms. The findings, reported in Clinical Microbiology and Infection, add to evidence that Long COVID may sometimes stem from persistent infection or SARS-CoV-2 protein remnants.” * * *
    • “More study is needed to understand the causes of Long COVID symptoms in people who test negative for persistent infection, the researchers note. They are conducting follow-up studies in even more people with Long COVID, including those with compromised immune systems. They hope to learn more about what causes some people to be at higher risk for retaining some SARS-CoV-2 protein remnants and Long COVID.”
  • Per an NIH press release,
    • “Young people with severe obesity who underwent weight-loss surgery at age 19 or younger continued to see sustained weight loss and resolution of common obesity-related comorbidities 10 years later, according to results from a large clinical study funded by the National Institutes of Health (NIH).
    • “Study participants with an average age of 17 underwent gastric bypass or sleeve gastrectomy weight-loss surgery. After 10 years, participants sustained an average of 20% reduction in body mass index (BMI), 55% reduction of type 2 diabetes, 57% reduction of hypertension, and 54% reduction of abnormal cholesterol. Both gastric bypass and sleeve gastrectomy had similar results.
    • “The 55% reduction in type 2 diabetes was much higher than the rates observed in adults after weight-loss surgery (18% at seven years and 12.7% at 12 years) in a recently published NIH-funded study.
    • “Type 2 diabetes tends to progress more rapidly when it occurs in young people, and these findings demonstrate the greater health benefits and durability of bariatric surgery in youth than would be expected in similarly treated adults.”
  • JAMA Open Network tells us,
    • Question  How have autism diagnosis rates changed over time among children and adults seeking care from a network of health systems in the US?
    • Findings  In this cross-sectional study of electronic US health and insurance claims records for over 9 million individuals per year from 2011 to 2022, relative increases in autism diagnosis rates were greatest among young adults compared with all other age groups, female compared with male individuals, and some racial and ethnic minority groups compared with White individuals among children but not adults.
    • Meaning  Patterns of increase in autism diagnosis rates reflect a need for expanded health care services and continued research on sociodemographic disparities among this growing population.
  • The Institute for Clinical and Economic Review published an Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
    • Current evidence suggests that tabelecleucel provides a substantial net health benefit when compared to usual care; treatment would achieve common thresholds for cost-effectiveness if priced between $143,900 to $273,700 per treatment cycle. * * *
    • “EBV+ PTLD is a rare and often fatal cancer associated with solid organ transplant and stem cell transplant,” said ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “Unfortunately, approximately half of EBV+ PTLD cases are refractory to initial treatment or relapse, resulting in a poor prognosis. The limited evidence on tabelecleucel suggests that it provides important clinical benefits in patients with relapsed refractory EBV+ PTLD, extending survival for patients who otherwise do not usually survive beyond a few weeks to months, with few harms.” 
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on November 14, 2024. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • STAT News informs us,
    • After spending decades fixated on a single hypothesis, Alzheimer’s researchers are increasingly searching for new ways to combat the devastating neurologic disease. One such approach — precisely targeting the brain with magnetic pulses — got a boost when mid-stage trial data was presented Thursday.
    • Scientists reported that patients with mild or moderate Alzheimer’s who received the therapy, known as transcranial magnetic stimulation (TMS), experienced a 44% slowing in their rate of disease progression after a year compared to those given a sham intervention, which mimicked the procedure but delivered no treatment. That finding, which was the study’s main endpoint and was statistically significant, was based on a commonly used disease metric known as Clinical Dementia Rating sum of boxes (CDR-SB).” * * *
    • “But outside experts were quick to caution that the new results, announced at the Clinical Trials on Alzheimer’s Disease conference in Madrid, should be taken with a grain of salt. That’s because the findings come from a small Phase 2 trial conducted at a single medical center in Italy, with 32 patients completing the trial. Sinaptica, a private biotech in Cambridge, Mass. that is developing the treatment and sponsored the trial, is now planning a larger, multicenter pivotal study in hopes of confirming its findings.”

From the U.S. healthcare business front,

  • The American Hospital News lets us know,
    • “Baxter announced Oct. 31 that it has restarted its North Cove, N.C. facility’s highest-throughput IV solutions manufacturing line, which normally accounts for nearly 25% of the site’s total production and approximately 50% of its one-liter IV solutions — the most commonly used size by hospitals and clinics. The earliest new products could begin shipment is late November, Baxter said. The company is continuing to assess and repair equipment at the facility and is working with the Food and Drug Administration to resume operation in phases. Baxter said it does not have a timeline on when production at the facility will be restored to pre-Hurricane Helene levels.” 
  • Healthcare Dive relates,
    • “Cigna CEO David Cordani threw cold water on speculation that the health insurer is interested in acquiring rival Humana during a call with investors on Thursday.
    • “Despite reports earlier this fall that the two payers had reopened deal talks, Cigna plans to use excess cash to buy back shares, Cordani said while discussing Cigna’s third quarter results.
    • “Cigna handily beat Wall Street expectations in the quarter with revenue of $63.7 billion, up 30% year over year after strong demand for specialty drugs spurred growth in its health services division. However, an investment loss of $1 billion tied to the waning value of primary care chain VillageMD drove Cigna’s profit down to $739 million, compared to $1.4 billion same time last year.”
  • Risk & Insurance points out,
    • “Employers that implement strategies like value-based drug formularies and tiered provider networks are experiencing lower health care costs, according to a survey by the National Alliance of Healthcare Purchaser Coalitions.
    • “The survey, which included responses from 188 employers, sheds light on the ongoing challenge of rising health care costs and the various approaches being taken to address this issue, which has significant implications for both businesses and employees.”
  • Modern Healthcare informs us,
    • “Steward Health Care completed the $245 million sale of its physician group, Stewardship Health, to private equity-owned Rural Healthcare Group.
    • “As part of the transaction, Kinderhook Industries, the private equity firm that owns Rural Healthcare Group, plans to rebrand the combined company as Revere Medical, Kinderhook said Thursday in a news release. The acquisition adds about 5,000 employed and affiliated Stewardship physicians across nine states to Revere’s network of 17 primary care clinics in Tennessee and North Carolina.
    • “Revere plans to invest in Stewardship infrastructure and technology and has pledged to allow patients to stay with their doctors, according to the release.
    • “The Stewardship team is excited for this next chapter with Revere Medical as it provides a committed partner focused on quality care and improving the clinic experience for providers, clinic teams, and patients,” Dr. Joseph Weinstein, president of Stewardship, said in the release.
    • “The Stewardship sale is one of the last remaining transactions in Steward’s Chapter 11 bankruptcy restructuring.”
  • Per Fierce Healthcare,
    • “Optum Rx is rolling out a slate of new programs that seek to support independent pharmacies in managing costs and more complex patient needs.
    • “The first offering under this initiative is Optum’s new Independent Pharmacy Network, which is available as an add-on for its pharmacy benefit management clients. In contracts that select this option, independent and community pharmacies will receive 5% higher reimbursements for generics and 0.2% higher for branded drugs.
    • “The PBM said this program follows other changes enacted to support independent pharmacies; for instance, it does not collect direct and indirect remuneration, or DIR, fees and removed clawbacks for independent facilities.”
  • and
    • “Teladoc Health had a better quarter than Wall Street expected, posting $640.5 million in revenue and losing less per share than expected, at $0.19. Quarterly revenue decreased by 3% from 2023 and was down slightly from Q2’s $642.4 million.
    • “In the Q3 earnings call, Teladoc executives stressed the stability of the U.S. virtual care segment, which has gained millions of users since last year. It called BetterHelp a “company in transition,” as the company pivots hard to offset the cost of a $790 million impairment charge in the second quarter.
    • “BetterHelp, Teladoc’s virtual mental health solution, continue to drag down its performance as the segment’s revenue fell 10% year-over-year, coming in at $256.8 million in Q3.”
  • Per Fierce Pharma,
    • “Bristol Myers’ $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company’s ongoing efficiency push. 
    • “BMS management is “reviewing overall spending and prioritizing investments that will deliver the best long-term returns,” CEO Chris Boerner, Ph.D., said during a call Thursday. The New Jersey-based pharma is on track to deliver on its existing $1.5 billion cost-saving target by the end of next year, the CEO confirmed.
    • “We see the drive for greater operational excellence as a continuous process,” Boerner continued. “As such, we are exploring opportunities to further improve productivity and efficiency over the coming quarters.”
    • “Later during the call, CFO David Elkins said BMS is “continuing to look for efficiencies in our cost base, and you’ll continue to hear more about that.”
  • Per BioPharma Dive,
    • “Sales of GSK’s top-selling vaccines fell sharply during the third quarter amid lower demand, sending shares in the British pharmaceutical company down 3% in U.S. trading Wednesday.
    • “GSK, which had downgraded its vaccine sales forecasts in July, did so again Wednesday in reporting earnings for the third quarter. The company now expects vaccine sales to decline by low single digits versus last year.
    • “During the third quarter, sales of GSK’s shingles vaccine dropped by 7% compared to the same period in 2023, while sales of its shot for respiratory syncytial virus, Arexvy, plunged by 72% year over year.
    • “In a presentation, GSK attributed the drop of Arexvy to several factors, including a narrower recommendation from the Centers for Disease Control and Prevention, prioritization of COVID vaccinations in the U.S. and lower rates of RSV infections this season.
    • “The decline mirrored that of Pfizer’s competing vaccine Abrysvo, sales of which came in lower this quarter compared to last year’s. Pfizer also cited the CDC recommendation, which focuses on vaccination for adults 75 years or older, as well as those between 60 and 74 years who are at higher risk of disease. Previously, the CDC had urged all adults 60 and older — for whom both Arexvy and Abrysvo are approved — to discuss vaccination with their doctor.”
  • Per Healthcare Dive,
    • “Oracle will launch a new artificial intelligence-backed electronic health record next year, the technology giant said Tuesday.
    • “The EHR will allow clinicians to use voice for navigation and search. It will also integrate the company’s clinical AI agent and tools for data analysis and tracking patient flow through the hospital.
    • “The new record marks a major health initiative for Oracle, which acquired EHR vendor Cerner for more than $28 billion in 2022. “This isn’t a refurbished Cerner EHR,” Seema Verma, executive vice president and general manager of Oracle Health and Life Sciences, said during the Oracle Health Summit on Tuesday. “Because in this day and age, you can’t leverage modern technology by bolting new innovation to something built in the 1990s.”

Midweek Update

David Ermer–Congress, FDA, Medical / Rx research, NIH, No Surprises Act–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • MedPage Today tells us,
    • “A bipartisan group of House members introduced a bill Tuesday that would reverse a proposed 2.8% Medicare Physician Fee Schedule payment cutopens in a new tab or window and give physicians a raise equivalent to half of the increase in the Medicare Economic Index (MEI), a measure of healthcare inflation.
    • “America’s physicians are at a breaking point and access to high-quality, affordable care is at risk for millions of Medicare patients,” Rep. Greg Murphy, MD (R-N.C.), one of the bill’s co-sponsors, said in a statement. “When a physician sees a Medicare patient, they do so out of the goodness of their heart, not because it makes financial sense … Unfortunately, reimbursements continue to decline, putting immense pressure on doctors to retire, close their practices, forgo seeing new Medicare patients, or seek a less efficient employment position. This bipartisan legislation would stop yet another year of reimbursement cuts, give them a slight inflationary adjustment, and protect Medicare for physicians and patients alike.”
  • Roll Call lets us know,
    • ​”With all eyes on next week’s elections, appropriations battles are simmering on the back burner for Congress. But lawmakers won’t have long to make some tough decisions when they return starting on Nov. 12 for the lame-duck session.
    • “The priorities are twofold: first, passing an emergency relief package after two major hurricanes battered the Southeast, compounding pent-up demands for disaster aid going back to last year. Second, congressional leaders need to figure out what to do about funding the government beyond the stopgap law’s Dec. 20 deadline.
    • ‘The current betting is that there simply won’t be enough time in the five weeks of session remaining to strike the deals needed to put together thousands of pages of text fleshing out a dozen full-year fiscal 2025 spending bills. Top Democrats and appropriators on both sides of the Capitol will push that option, but without GOP leadership buy-in, it’s very unlikely.”
  • Today the U.S. Court of Appeals for the Fifth Circuit handed a loss to the Texas Medical Association (TMA) in the No Surprises Act cases.
    • The Court summarized its holdings as follows
      • “We conclude that the provisions of the Rule related to QPA calculations are lawful and therefore REVERSE the district court’s holdings as to those provisions. We further conclude that the Rule’s deadline provision is unlawful and therefore AFFIRM the district court’s holding as to that provision. Finally, we conclude that the Rule’s disclosure requirements are lawful and therefore AFFIRM the district court’s holding as to those provisions.”
    • The first and third holdings are the TMA loss.  Last December, CMS implemented the district court’s QPA calculation decision in its NSA guidance.  The FEHBlog imagines that CMS may reverse that December 2023 guidance soon.
    • The second holding means that health plans must pay or deny an NSA claim within 30 calendar days after receipt. The clean claim consideration was rejected by the district court and the court of appeals. 

From the public health and medical research front,

  • The Washington Post reports,
    • “The bird flu outbreak in dairy cows has spread to at least one pig on a backyard farm in Oregon, the first detection of the H5N1 virus in swine in the United States, the U.S. Department of Agriculture said Wednesday.
    • “The discovery is particularly concerning to scientists and public health officials because pigs can become coinfected with bird and human viruses, allowing genes to swap to form a new, more dangerous virus that can more easily infect humans.
    • “Bird flu was first detected in poultry on the noncommercial farm, the Oregon agriculture department said Friday. The USDA’s National Veterinary Services Laboratories confirmed that one of the farm’s five pigs was infected with the virus on Tuesday but did not publicize the discovery until Wednesday.” * * *
    • “Once an avian virus like H5N1 gets into a pig, it can mix with other viruses — a process known as reassortment — and pick up the ability to grow better and adapt to make humans sicker, Webby said. At least 31 people have been sickened in the current bird flu outbreak, all with mild symptoms.
    • ‘Animals on the farm are not part of the commercial food supply, the USDA said. The discovery of bird flu in the swine has no impact on the safety of the nation’s pork supply.
    • “The farm’s small size gives the virus less opportunity to spill into humans, experts said.”
  • The New York Times informs us,
    • “The blockbuster drug semaglutide, sold as Ozempic for diabetes and as Wegovy for weight loss, now has a new proven benefit: It markedly soothed knee pain in people who are obese and have moderate to severe osteoarthritis, according to a large study.
    • “The effect was so pronounced that some arthritis experts not involved with the clinical trial were taken aback.
    • “The magnitude of the improvement is of a scope we haven’t seen before with a drug,” said Dr. Bob Carter, deputy director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. “They had an almost 50 percent reduction in their knee pain. That’s huge.”
    • “Dr. David T. Felson, an arthritis expert and professor of medicine at Boston University School of Medicine, said the study “changes the landscape,” adding that the pain reduction is greater than anything that can be achieved short of knee replacement surgery.”
  • and
    • “For decades, people with failing heart valves who nevertheless felt all right would walk out of the cardiologist’s office with the same “wait and see” treatment plan: Come back in six or 12 months. No reason to go under the knife just yet.
    • “A new clinical trial has overturned that thinking, suggesting that those patients would be much better off having their valves replaced right away with a minimally invasive procedure.
    • The trial, whose results were published this week in The New England Journal of Medicine, could change the way doctors treat severe aortic stenosis, a narrowing of the valve that controls blood flow from the heart. The disease, which has a prognosis worse than that of most cancers, afflicts more than 3 percent of people ages 65 and older. It is expected to become more common as people live longer.
    • “Replacing people’s heart valves, even if they were not yet experiencing any ill effects, appeared to roughly halve their risk of being unexpectedly hospitalized for heart problems over at least two years, the trial found.”
  • The Wall Street Journal adds,
    • “It is hard to mend a broken heart, but in a few years doctors might be able to do essentially that.
    • “Scientists are closing in on ways to help patients grow new heart muscle after a heart attack, as well as new lung tissue to treat fibrosis, corneas to erase eye pain and other body parts to gain a new chance at life.
    • “If the science works, it could represent a new approach to medicine: reversing rather than alleviating chronic illnesses.”
    • “The idea “is really to restore function to the organ such that the quality of life of that person is normalized,” says Peter Schultz, president and chief executive of Scripps Research, a nonprofit scientific institute in La Jolla, Calif., that is testing medicines to regenerate hearts, lungs and other organs.
    • “These treatments eventually might also be used to reverse the effects of aging, Schultz says. If they prove effective in people with disease, he says, they could be tested in healthy people to see if they can, say, “turn a 70-year-old heart into a 40-year-old heart.”
  • STAT News relates,
    • “An experimental Alzheimer’s therapy from Roche successfully cleared a protein that’s a hallmark of the disease from patients’ brains, the company reported Wednesday, adding to evidence that the drug shows promise.
    • “The data are from an early-stage trial and so far, Roche has not yet assessed whether there has been any corresponding change in cognitive function or disease progression. But U.S. regulators have in recent years approved similar medicines that can reduce levels of the protein, called amyloid, in patients’ brains and that in trials modestly slowed the worsening of Alzheimer’s.
    • “What’s more, the early findings of Roche’s treatment, an antibody called trontinemab, suggest it could be safer than some of the other amyloid-clearing treatments, although larger studies would need to confirm that. In particular, there have been comparatively few cases of an issue called ARIA, a type of brain swelling or bleeding, that has been seen with the other antibodies and that has led regulators in some parts of the world to take negative views of the existing drugs.”
  • Beckers Hospital Review alerts us,
    • “A recent study revealed a 17.5% increase in asthma-related hospitalizations in the three months following the announcement that GSK would discontinue the widely used asthma medication Flovent, and 24.1% in the following three to six months, ABC News reported Oct. 30. 
    • “The research, conducted by EPIC Research, analyzed data from over 3 million patients and highlighted the potential risks associated with the switch to alternative medications. 
    • ‘Five-year-old Burton Hayes, whose asthma was previously well managed on Flovent, faced significant health challenges after his mother was forced to switch his medication, ABC News reported. Reports indicated a sharp rise in asthma exacerbations among patients following the discontinuation, leading to an increase in emergency room visits and hospital admissions. 
    • “The decision to halt Flovent’s production came after a Federal Trade Commission warning about its patent. To comply with regulatory changes and avoid potential financial penalties, GSK shifted to an authorized generic, fluticasone propionate. However, many patients are finding that the new generic is not covered by insurance, complicating access, according to the ABC News report.”
  • CIGNA points out “fifteen stats illustrating cancer’s impact on people, employers, and health care costs.”
  • Per an NIH press release,
    • “New insights from multiple studies provide critical information on how cancer tumors develop, spread, and respond to treatments. The 10 studies from the Human Tumor Atlas Network (HTAN), a National Institutes of Health (NIH)-funded Cancer Moonshot℠ initiative to construct three-dimensional maps of human tumors, will be published Oct. 31, 2024, across several Nature journals.
    • “Several studies explore the role of the tumor microenvironment and the immune system in promoting the spread of cancer and its resistance to treatment. Three studies map the trajectory of precancerous colorectal tissues toward cancer by measuring the contributions of multiple molecular and cellular events. Multiple new HTAN papers describe the development of innovative single-cell technology and analysis platforms. An accompanying research briefing by W. Kimryn Rathmell, M.D., Ph.D., director of NIH’s National Cancer Institute (NCI), and Dinah Singer, Ph.D., NCI deputy director for scientific strategy and development, discusses the history, progress, and future of HTAN.
    • “Launched in 2018, HTAN constructs three-dimensional maps of human tumors that capture their molecular features and surrounding microenvironments over time. The work is being done by teams of investigators from research institutions across the country using a variety of technologies and computational approaches to study tumors at the single-cell level. This comprehensive, publicly available resource aims to help researchers better understand the development and progression of cancer to inform its prevention and treatment. The first tumor atlas studies from this initiative were published in 2020 and 2021.” * * *
    • “The collection page is available at https://www.nature.com/collections/fihchcjehc.”

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “Actions taken by Humana to weather tumult in the Medicare Advantage program appear to be bearing fruit. On Wednesday, the insurer reported better-than-anticipated third quarter results and modestly increased its 2024 earnings guidance after retaining more MA seniors than expected — and those members having higher risk scores, boosting reimbursement.
    • “Humana now expects to add 265,000 individual MA members this year, representing 5% growth, compared to its previous guidance of 225,000 new MA members.
    • “Despite the stronger membership, Humana doesn’t expect earnings growth in 2025 because of heavy investments the insurer plans to make to boost its MA stars — valuable quality ratings linked to plans’ revenue in the privatized Medicare program.”
  • Per BioPharma Dive,
    • “Eli Lilly’s seemingly inexorable growth hit a speed bump Wednesday, when the Indianapolis drugmaker reported earnings for the third quarter that missed Wall Street expectations and sent shares down sharply.
    • “Overall, revenue reached $11.4 billion between July and September, up 20% from the same period last year but higher by only 1% versus the second quarter and well below the consensus forecast of about $12.1 billion.
    • “Lilly’s sales and stock price have swelled on surging demand for the company’s GLP-1 medicines Mounjaro and Zepbound, which it respectively sells for diabetes and obesity.
    • “The company has had difficulty meeting that demand, though, leading to shortages that have hampered the drugs’ availability. (In October, the Food and Drug Administration officially removed Mounjaro and Zepbound from its shortage list, but is now reconsidering that decision.)
    • “Compared to the third quarter last year, sales of the two drugs are significantly higher, respectively reaching $3.1 billion and $1.26 billion during the period. But both totals were lower than analysts expected and roughly flat compared to the second quarter.”
  • and
    • “All doses of Novo Nordisk’s popular GLP-1 medicines Ozempic and Wegovy are available in the U.S. and being regularly shipped to wholesalers, the drugmaker confirmed Wednesday.
    • “One dose form or another of both drugs, which respectively treat diabetes and obesity, has been in shortage since March 2022, according to a database maintained by the Food and Drug Administration. The database was updated Wednesday to reflect the drugs’ new availability, although both remain listed.
    • “In an emailed statement, Novo cautioned that, “even when a medication is available, patients may not always be able to immediately fill their prescription at a particular pharmacy.” The statement added that people seeking to fill a prescription may experience this “variability” regardless of whether a drug is actively in shortage.”
  • Per Fierce Pharma,
    • “It’s a new era for AbbVie. For the first time in years, the company has a new top sales driver as Skyrizi has overtaken Humira in quarterly sales.
    • “Humira heir Skyrizi has been slowly creeping up on the once-dominant Humira ever since biosimilar competition prompted the immunology king’s decline. With Skyrizi salesskyrocketing 50% to $3.2 billion during the third quarter, the drug took the sales crown from Humira, which has been trending down and generated $2.2 billion during the period.
    • “Skyrizi holds biologic share leadership in approximately 30 countries and boasts a “best-in-class profile” that presents a “very high bar” for rivals, AbbVie’s chief commercial officer Jeffrey Stewart said on the company’s third-quarter earnings conference call.
    • “After Skyrizi’s recent debut in ulcerative colitis, feedback and initial prescription trends have been “overwhelmingly positive,” Stewart added. The crowded ulcerative colitis market recently gained another competitor in Johnson & Johnson’s Tremfya, setting up a fierce fight for dominance between the pharma giants. However, Skyrizi has a leg up with its prior Crohn’s disease nod, which represents the second form of inflammatory bowel disease (IBD).”
  • Fierce Healthcare tells us,
    • “Online therapy company Talkspace grew its revenue 23% in the third quarter, bringing in $47.4 million, and turned last year’s net loss into a profit of $1.9 million.
    • “The company continues to expand its business with payers and employers and now covering 158 million people in-network and through Medicare/Medicare Advantage plans, an increase of 40% year-over-year, Talkspace announced in its third-quarter earnings report released Tuesday. As Talkspace grows, it is increasing access to virtual behavioral health services for seniors, teens and members of the U.S. military, exectives said.
    • “This past quarter marks Talkspace’s third consecutive quarter of adjusted EBITDA profitability. Adjusted EBITDA came in at $2.4 million in Q3, an improvement from a loss of $2.8 million a year ago and beating Wall Street analysts’ consensus estimate of $1.4 million.”
  • Beckers Payer Issues identifies “the investments 18 payer executives are most excited about.” Check it out.

Tuesday Tidbits

David Ermer–AHRQ, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Federal News Network reports on the Postal Service Health Benefits Program supplemental rule creating a Medicare Part D EGWP mandate for Postal annuitants over 65, other than those living abroad.
  • While the FEHBlog thinks that the new, improved 2025 version of Medicare Part D is a good deal for FEHB and PSHB annuitants over age 65, even for those with the IRMAA tax or manufacturer coupons, the FEHBlog objects to the OPM mandate because it penalizes annuitants who opt out of the Plan’s Part D EGWP by barring them from the Plan’s prescription drug benefits without any premium reduction. Although FEHB plans do include penalties for failing to use hospital pre-certification, for example, those penalties top out at $500. Prescription drugs represent 24 cents out of every healthcare dollar according to AHIP. If Congress had intended that OPM impose such a hefty penalty, it would have said so in the Postal Reform Act. The law, however, is silent.
  • FedSmith offers advice on the upcoming Open Season while FedWeek explains the pros and cons about FEHB / PSHP high deductible plans with health savings accounts.
  • Per a CMS press release,
    • “The Centers for Medicare & Medicaid Services (CMS) announced today that the Medicare Shared Savings Program (Shared Savings Program) continues to save Medicare money while supporting high-quality care. The Shared Savings Program yielded more than $2.1 billion in net savings in 2023 — the largest savings in the Shared Savings Program’s history. In addition, Shared Savings Program Accountable Care Organizations (ACOs) are providing higher-quality care and supporting policies CMS has adopted to enhance primary care, expand access to accountable care to underserved communities, and prioritize quality care for common chronic conditions.
    • “In 2023, ACOs in the Shared Savings Program earned shared savings payments (also known as performance payments) totaling $3.1 billion, the highest since the program’s inception more than 10 years ago.  In addition, ACOs scored better on many quality measures than other types of physician groups and continued to demonstrate quality improvement. ACOs led by primary care clinicians had significantly higher net per capita savings than ACOs with a smaller proportion of primary care clinicians. These results continue to underscore how important primary care is to the success of the Shared Savings Program.”
  • Healthcare Dive tells us,
    • “Oracle Health will apply to become a Qualified Health Information Network under the federal government’s health data exchange framework, the technology giant said Monday. 
    • “TEFCA, or the Trusted Exchange Framework and Common Agreement, uses QHINs — which can represent dozens or hundreds of health systems, public health agencies, payers and health IT vendors — to support health information sharing, according to the HHS’ Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT.
    • “To get official designation, QHINs have to complete technology and security testing and agree to the data sharing rules before being onboarded. TEFCA went live in December with five QHINs, and two more organizations were approved early this year.”

From the public health and medical research front,

  • Fierce Pharma informs us,
    • “A small tweak in the dosing regimen of Eli Lilly’s Alzheimer’s disease drug Kisunla has reduced brain swelling of patients in a trial, the company said Tuesday.
    • “In the phase 3 study, 14% of patients who were on the altered dosing plan experienced brain swelling (ARIA-E) events at Week 24 versus 24% of those who received the standard dosing of Kisunla, which was approved by the FDA in July.
    • ‘The difference adds up to a 41% reduction in ARIA-E and could lead to a label change and help convince doctors to prescribe the anti-amyloid therapy, which is competing with another Alzheimer’s drug in its class, Eisai and Biogen’s Leqembi.”
  • Per MedTech Dive,
    • “Edwards Lifesciences’ Early TAVR trial results showed asymptomatic patients with severe aortic stenosis had better outcomes after transcatheter aortic valve replacement than under routine clinical surveillance.
    • “Analysts said the positive data could help Edwards reaccelerate growth in its TAVR business, where sales have slowed in recent quarters. The data were presented Monday at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium and published simultaneously in The New England Journal of Medicine.
    • “The study is the first randomized, controlled trial to look at early intervention with TAVR as a strategy in patients with asymptomatic severe aortic stenosis, according to Edwards. The study was funded by Edwards.”
  • Per a company press release,
    • “Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that its double-blind, randomized, placebo-controlled global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP), met its primary endpoint. Once-daily ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) demonstrated a statistically significant reduction in the proportion of participants with symptomatic SARS-CoV-2 infection after exposure to household contacts with COVID-19 when compared to placebo. Specifically, the primary endpoint assessed COVID-19 symptoms onset through Day 10. Ensitrelvir was well tolerated by study participants and no new safety concerns were identified.
    • “Ensitrelvir is an investigational oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration in 2023 for the treatment of COVID-19. In Japan, ensitrelvir, known as Xocova®, received emergency regulatory approval in 2022 and full approval in March 2024 for the treatment of COVID-19. Ensitrelvir was also made available in Singapore based on the Special Access Route application in 2023. It remains an investigational drug outside of Japan and Singapore.
    • “COVID-19 remains an important public health priority, yet there are currently no oral antiviral medications approved for post-exposure prophylactic use. There is a need for convenient, preventive approaches to protect ourselves and those close to us from contracting SARS-CoV-2,” said Simon Portsmouth, MD, FRCP, Senior Vice President, Head of Clinical Development. “These data demonstrate a new potential for post exposure prophylactic use of ensitrelvir, expanding on the breadth of clinical and real-world evidence that establish its activity in those infected with SARS-CoV-2.”
  • AHRQ’s Medical Expenditures Panel Survey lets us know,
    • Among adults who reported ever having COVID-19, 13.7 percent reported ever having long COVID.
    • Women were more likely than men to report ever having long COVID (16.5% vs. 10.5%).
    • Adults aged 18-34 were less likely than all other age groups to report ever having long COVID (9.8% vs. 13.5%-17.9%).
    • Adults living in high-income households were less likely to report ever having long COVID (11.0%) than those living in middle-income households (15.6%), low-income or near poor households (17.4%), and those living in poor households (17.2%).
    • Adults living in a metropolitan statistical area reported lower rates of ever having long COVID than those living outside of a metropolitan statistical area (12.7% vs. 19.7%).
  • MedPage Today points out,
    • “Elevated body mass index (BMI) in children and young adults was associated with an increased risk of post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID, a large retrospective cohort study suggested.
    • “Those with obesity had a 25.4% increased risk of long COVID (relative risk [RR] 1.25, 95% CI 1.06-1.48) and those with severe obesity had a 42.1% increased risk (RR 1.42, 95% CI 1.25-1.61) compared with children and young adults who had healthy weight, reported Yong Chen, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.
    • “Similarly, there was an increased likelihood of encountering any manifestation of potential long COVID symptoms and conditions among those with obesity (RR 1.11, 95% CI 1.06-1.15) and severe obesity (RR 1.17, 95% CI 1.14-1.21), they said in JAMA Network Openopens in a new tab or window.
    • “To our knowledge, this retrospective cohort study is the first and the largest to explore the association of BMI status with PASC among the pediatric population,” Chen and co-authors wrote. “The findings suggest that PASC may lead to poorer long-term quality of life, affecting physical health, educational achievement, and social development; this underscores the importance of early identification, prevention, and targeted interventions to mitigate these risks.”
  • The U.S. Preventive Services Task Force (USPSTF) has opened for a public comment the following recommendations:
    • Population: Pregnant or postpartum persons and women of reproductive age
    • Recommendation: The USPSTF recommends that clinicians screen for intimate partner violence (IPV) in pregnant and postpartum persons and women of reproductive age. See the “Practice Considerations” section for information on evidence-based multicomponent interventions and for information on IPV in men.
    • Grade: B
      Population: Older or vulnerable adults
      Recommendation The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for caregiver abuse and neglect in older or vulnerable adults. See the “Practice Considerations” section for additional information.
      Grade: I (inconclusive)
    • “In 2018, the USPSTF recommended that clinicians screen for IPV in women of reproductive age and provide or refer women who screen positive to ongoing support services. The USPSTF also concluded that the evidence was insufficient to assess the balance of benefits and harms of screening for abuse and neglect in all older or vulnerable adults. The current draft recommendation statement is consistent with the 2018 recommendation. To highlight that the evidence base focused on pregnant and postpartum persons, the USPSTF emphasized this population in this draft recommendation statement. For abuse of older or vulnerable adults, the term “caregiver” was added before abuse or neglect when appropriate to clarify when the focus was on screening for abuse or neglect perpetrated by a caregiver or someone they trust.”
    • The public comment deadline is November 25, 2024.
  • Healio relates that “A modified screening with additional questions about suicidal ideation was better at predicting suicide attempts among adolescents than the standard questionnaire, according to findings published in JAMA Network Open.“
  • The Wall Street Journal notes,
    • “In Appalachia, in the heart of one of the earliest and deadliest waves of the opioid crisis, doctors at West Virginia University’s Rockefeller Neuroscience Institute are conducting a radical experiment. Using focused ultrasound waves, they are resetting cells inside the brain’s reward center, the nucleus accumbens. They hope the procedure can treat addictions ranging from drugs like opioids and methamphetamine to gambling and eating. 
    • “While neuroscientists have long defined addiction as a brain disease, tools to fight the U.S. drug crisis that is behind 100,000 overdose deaths a year have changed little in decades. Most treatment involves medications like methadone and buprenorphine to replace other opioids, or naltrexone to block the part of the brain that feels pleasure from alcohol or opioids. For many addictions, counseling and abstinence-based 12-step programs remain the go-to treatment. 
    • “At RNI’s 30-patient residential-treatment program, more than two-thirds of patients relapse within the first few weeks. Many illicit drugs, including meth and cannabis, don’t have any prescription medications to treat the addiction.
    • “Now, the institute’s trial using ultrasound is a peek at a future that treats the physical brain, rather than using medication or behavioral approaches to alter outcomes. “We need to inject technology into this,” said Dr. Ali Rezai, a neurosurgeon and executive chair at the institute.
    • “The RNI team is also studying a pill that monitors vital signs and releases overdose-reversal medication automatically in people who overdose. In another trial, they are monitoring the heart rates, emotions, sleep and cravings of thousands of drug users who are helping to train artificial intelligence to predict a relapse before it occurs, so that recovery coaches can intervene.”   

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Pfizer PFE punched back against activist investor Starboard Value on Tuesday, delivering positive quarterly results.
    • “The pharmaceutical company raised its revenue outlook for the year to between $61 billion to $64 billion, up from $59.5 billion to $62.5 billion previously. It also raised its guidance on adjusted annual earnings per share to a range of $2.75 to $2.95, up from $2.45 to $2.65. 
    • “The encouraging third quarter comes as Pfizer faces pressure from activist investor Starboard, which says poor investments in research and dealmaking have helped destroy billions of dollars in market capitalization. The latest earnings highlight Pfizer’s third consecutive quarter with positive results—a bright spot that could bolster the drugmaker, and Chief Executive Albert Bourla’s efforts to revamp the company. 
    • ‘Pfizer also beat Wall Street’s expectations on quarterly sales and earnings. The company reported sales totaling $17.7 billion, driven by Covid-19 products and cancer medicines, up from the $14.9 billion forecast by analysts surveyed by FactSet. The Covid-19 antiviral Paxlovid generated $2.7 billion in quarterly sales, while its Covid-19 vaccine Comirnaty sold $1.4 billion, both topping analyst forecasts.”
  • Modern Healthcare informs us,
    • “CVS Health’s MinuteClinic is becoming an in-network primary care provider for select Aetna plan members.
    • “Aetna commercial, individual and family health plan members in San Antonio, Houston, Atlanta and south Florida have the option to use MinuteClinic as an in-network primary care provider, with members in North Carolina becoming eligible in the coming weeks, said Dr. Creagh Milford, retail health president at CVS Health.
    • “CVS has been investing in staffing, technology and training at its MinuteClinic sites for months to expand primary care services in certain markets chosen based on patient density, demographics and existing services in those areas, Milford said.
    • “We’re seeing a lot of growth in the model,” Milford said. “Our ambition is to move the patient perception and the payer perception from one of an episodic, acute care model toward a longitudal, relationship-based primary care model.”
    • “CVS is in talks with other health plans to grow the MinuteClinic primary care approach, he said.”
  • STAT News tells us,
    • “More than a year has passed since Dana-Farber Cancer Institute dumped Mass General Brigham for a rival hospital chain, but the state’s biggest health care system is making a push now to say when it comes to cancer care, MGB’s still got it.
    • “Beginning in 2028, Dana-Farber will end its long and nationally acclaimed adult oncology partnership with Brigham and Women’s Hospital. Instead, it will team up with Beth Israel Deaconess Medical Center to open a new freestanding 300-bed, $1.68 billion cancer hospital in the Longwood Medical Area.
    • “Dana-Farber’s announcement of the divorce in September 2023 stunned executives at the Brigham and rocked the hyper-competitive hospital industry. But now MGB is fighting back by creating what it calls the Mass General Brigham Cancer Institute, which the health system is trumpeting in an intensive marketing campaign.
    • “The institute won’t be a freestanding hospital. But it will, for the first time, combine the expertise and resources of MGB’s two flagship hospitals, Massachusetts General Hospital and the Brigham, whose cancer operations were previously separated by a firewall because of the latter’s partnership with Dana-Farber.
    • “What really started as a disruptive event a year ago, saying that Dana-Farber will be exiting after a few years, has now become a new opportunity for us to rethink how we deliver care,” O’Neil Britton, chief integration officer for MGB, said Monday at a round-table discussion at Massachusetts General Hospital with reporters.”
  • Per Fierce Pharma,
    • “Exactly three years after an initial FDA green light for the third-line treatment of leukemia, Novartis’ Scemblix has won an accelerated approval to treat newly diagnosed patients.
    • “Tuesday, the FDA cleared Scemblix to treat patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. The first-line nod marks an important step for the Gleevec follow-up on its way toward reaching the company’s peak sales projection of $3 billion. 
    • “Only about 15% of Ph+ CML patients reach the third-line treatment setting, Victor Bulto, Novartis’ U.S. president, noted in an interview with Fierce Pharma. 
    • “The Swiss drugmaker has its work cut out in this use. While Scemblix has quickly become the standard of care in third-line Ph+ CML because of a lack of alternative treatments, the first-line market will feature a couple hurdles for the new entrant.”
  • Per BioPharma Dive,
    • “Paragon Therapeutics, a biotechnology company creator with a web of spinouts, is taking a new startup public to develop an emerging type of cancer immunotherapy.
    • “The startup, Crescent Biopharma, on Tuesday announced a reverse merger with GlycoMimetics, a struggling, publicly traded developer of oncology and inflammatory disease drugs. In support of the deal, the combined company has raised $200 million in financing from 17 major investment firms — among them Fairmount and Venrock Healthcare Capital Partners — and expects that money to keep it operating through 2027.
    • “The new company will take the Crescent name, be about 97% owned by Crescent stockholders, and be led by the startup’s interim CEO and Fairmount venture partner Jonathan Violin. Its chief goal will be to advance a group of cancer medicines led by a dual-pronged immunotherapy that simultaneously targets the proteins PD-1 and VEGF.
    • “Study results in September showed that approach could improve upon standard immunotherapy treatments, like Merck & Co.’s Keytruda. Drugs targeting PD-1 and VEGF have since drawn the interest of an array of biotech companies, of which Crescent is the latest to emerge.”
  • and
    • “GSK will pay $300 million to acquire a bispecific antibody from Shanghai-based Chimagen Biosciences that it believes has the potential to treat autoimmune diseases like lupus.
    • “The drug, which is currently in Phase 1 testing for cancer in the U.S. and China, is what’s known as a “T cell engager.” It binds to two cell surface proteins called CD19 and CD20, which GSK notes could help deplete malfunctioning B cells.
    • “In a Tuesday statement, GSK said it plans to begin a Phase 1 trial of Chimagen’s drug sometime next year, assuming the proposed licensing deal clears customary regulatory review.”

Monday Roundup

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

From Washington, DC,

  • Govexec offers a commentary on why federal and postal employees should consider a high deductible plan with a health savings account in the upcoming Open Season.
    • The FEHBP misses his CareFirst HDHP/HSA when Medicare became his primary health insurer at the end of 2019. The FEHBlog likes Medicare. He wonders whether the November 5 election is causing CMS to delay announcing Medicare premiums and cost sharing for 2025. Congress should pass a law requiring CMS to release this information before the beginning of the annual Medicare Open Enrollment on October 15.
  • Beckers Hospital Review lets us know,
    • Baxter has received FDA approval to extend the shelf life of more than 50 intravenous and irrigation products by up to 12 months, now allowing for a 24-month expiry from products made before September 2024, according to an Oct. 28 news release from the company. 
    • Here are four other IV shortage updates: 
      • A completed temporary bridge has already moved more than 825 truckloads of finished products from Baxter’s North Cove, N.C. facility. A second bridge is set to open in early November. 
      • Baxter anticipates restarting its primary IV solutions line the week of Oct. 28, aiming to begin distribution of new products by mid- to late November, the release said. 
      • Nine Baxter plants are supplementing North Cove’s output to stabilize supply levels in the U.S. 
      • Conservation efforts for IV and peritoneal dialysis solutions remain crucial, with Baxter’s supporting healthcare systems on product management strategies, according to the release. 
  • Federal News Network tells us,
    • “Agencies with higher employee satisfaction scores are also getting top marks on their performance.
    • “Research from the Partnership for Public Service finds agencies that received the highest internal customer experience scores also ranked high on the Federal Employee Viewpoint Survey.
    • “Brandon Lardy, the Partnership’s senior manager for data science and Strategy, said the study is part of its ongoing work to produce customer experience metrics on par with FEVS data or its Best Places to Work in the Federal Government ranking.”
  • The Wall Street Journal reports,
    • “The Biden administration took steps to alleviate shortages of cancer drugs for children, part of a final push for one of the president’s domestic priorities: reducing the nation’s cancer burden.
    • “The federal government is testing a new way to prevent treatment disruptions for seven pediatric cancer drugs by improving communication between hospitals, nonprofits and wholesalers. Shortages of cancer medicines regularly plague hospitals and patients, sometimes forcing them to delay or change care. 
    • “No one in this country should struggle for access to the treatment they need, but kids and families facing cancer in particular,” said Danielle Carnival, an adviser to Biden who leads his “Cancer Moonshot” effort.” 

From the public health and medical research front,

  • STAT News reports,
    • “If one can point to anything good about the H5N1 bird flu outbreak in dairy cattle — to be honest, there’s nothing good about this situation — it’s the timing. Transmission of the virus through U.S. dairy herds took off when last winter’s flu season was effectively over, making the job of looking for people infected with H5N1 an easier task in theory, though there have been plenty of human hurdles impeding those efforts.
    • “But in the months since the outbreak was first detected, the spread of the virus in cows has not been contained, with infections reported in 380 herds in 14 states so far. Now, with cold and flu season looming, it is likely to become significantly more difficult for the country’s public health departments to track the virus. 
    • “If one can point to anything good about the H5N1 bird flu outbreak in dairy cattle — to be honest, there’s nothing good about this situation — it’s the timing. Transmission of the virus through U.S. dairy herds took off when last winter’s flu season was effectively over, making the job of looking for people infected with H5N1 an easier task in theory, though there have been plenty of human hurdles impeding those efforts.
    • “But in the months since the outbreak was first detected, the spread of the virus in cows has not been contained, with infections reported in 380 herds in 14 states so far. Now, with cold and flu season looming, it is likely to become significantly more difficult for the country’s public health departments to track the virus.”
  • Beckers Hospital Review names the ten most health and the ten least health cities in our country.
    • “Detroit leads the list of cities with the least healthy populations, while San Jose, Calif., has the healthiest residents, according to a new ranking published Oct. 28 by Forbes Advisor, a financial services and personal finance website affiliated with Forbes.
    • “In making its determination, Forbes Advisor compared the 46 most populated U.S. cities with available data across eight metrics. Metrics ranged from the number of heart disease deaths per 100,000 residents to the percentage of adults who report physical inactivity.
    • “Data for the analysis comes from the City Health Dashboard and the Census Bureau. Read more about the methodology here.”
    • Austin, Texas, where the FEHBlog lives, is listed as the city with the second healthiest population, following San Jose, California.
  • Consumer Reports, writing in the Washington Post, discuss “seven winning dietary supplements for sleep, bone health and more. As for which brands, the key is choosing products that have been verified to be free of contaminants and to contain what their labels claim.”
  • Per National Institutes of Health press releases,
    • “A study from researchers at National Institutes of Health (NIH) and their collaborators revealed a significant genetic risk factor for kidney disease in people from Ghana and Nigeria. Their study demonstrated that having just one risk variant in a gene known as APOL1 can significantly increase the risk of developing kidney disease. APOL1 is important for the immune system and variants of the gene are linked to increased risk of chronic kidney disease. The study is published in the New England Journal of Medicine and was conducted by researchers from the Human Heredity and Health in Africa (H3Africa) Kidney Disease Research Network.
    • “Previous research established that genomic variants in APOL1 increase the risk of developing chronic kidney disease among African Americans. However, not much is known about how these genomic variants affect people from West African countries, where many African Americans derive genetic ancestry. Studying how these genomic variants contribute to chronic kidney disease in West Africans and people with West African ancestry can also help inform the risk of kidney disease in many Americans.”
  • and
    • “A highly pathogenic avian influenza (HPAI) H5N1 virus, isolated from the eye of a farm worker who became infected through contact with dairy cows, was lethal in mice and ferrets infected in a high-containment laboratory environment, according to a new study in Nature. The study investigators also found that the virus isolated from the worker, who experienced mild inflammation of the cornea (conjunctivitis), could be transmitted through the air between separated ferrets and might be capable of binding to and replicating in human respiratory tract cells.
    • “The virus isolated from the worker is called huTX37-H5N1 and has a mutation (PB2-E627K) frequently seen in avian influenza viruses that replicate in mammals, typically making virus replication more efficient. These mutations underscore the need for continued monitoring and evaluation of viruses from the current H5N1 outbreak.
    • “The study also showed that a bovine H5N1 virus is susceptible to the antiviral drugs favipiravir and baloxavir marboxil (brand name Xofluza) of the polymerase inhibitor class, as well as the neuraminidase inhibitor zanamivir. The virus is less sensitive to oseltamivir (Tamiflu), another neuraminidase inhibitor.” * * *
    • “In summary, this study characterizes the huTX37-H5N1 isolate, finding that it may be capable of replicating in cells of the respiratory tract in humans, that it is pathogenic in mice and ferrets, and that it is capable of being transmitted by the respiratory route in ferrets. The authors note that “based in these observations, every effort should be made to contain HPAI H5N1 outbreaks in dairy cattle to limit the possibility of further human infections.”
  • From the U.S. healthcare business front,
  • AHIP shows us where our healthcare dollar goes.
  • For experience rated FEHB plans, which serve the vast majority of subscribers, the profit is less than one cent of each dollar. Other FEHB plans can enjoy the 2.4 cents profit.
  • Beckers Hospital Review points out “50 things to know about hospital consolidation and what consolidation means for the future of healthcare.
  • Per Fierce Healthcare
    • “Leaders at UnitedHealth Group and Amedisys are set to meet with the Department of Justice this week in hopes of avoiding a potential attempt to block their $3.3 billion merger deal, according to media reports.
    • “Bloomberg reported that the “last rites” meeting is generally the last step before regulators decide to intervene in a deal or not. It’s possible that the antitrust enforcers will allow the two companies to move forward with the deal with some changes that address competition concerns, according to the article.
    • “People familiar with the matter told Bloomberg there has been no definitive decision to challenge the deal. The DOJ will need to make a choice by the end of the month, based on an arrangement with UHG and Amedisys, according to the article.”
  • and
    • “Elevance Health plans to acquire home health company CareBridge in a deal that’s reportedly worth $2.7 billion.
    • “Elevance CEO Gail Boudreaux told investors on the company’s earnings call earlier this month that the company’s Carelon division “recently” entered into a deal to acquire CareBridge. 
    • “Further details on the transaction have not yet been disclosed. The Nashville Business Journal, where CareBridge is based, reported that Elevance Health would pay $2.7 billion for the home health company. The article called CareBridge the “fastest growing” company in the Tennessee city.
    • “On the call, Boudreaux said that CareBridge will “serve as the foundation for Carelon’s home health business, and we’re excited to continue to serve all its customers and members.” CareBridge provides value-based care in the home and community for people with complex and chronic conditions.”
  • and
    • “Universal Health Services (UHS) beat analysts’ estimates for third-quarter revenue as its top line grew 11% from 3.963 billion to reach $3.96 billion thanks to solid growth by its acute care hospitals and behavioral health care services.
    • “A year ago, UHS brought in $3.56 billion in revenue in the third quarter of 2023.
    • “The King of Prussia, Pennsylvania-based for-profit health system reported that adjusted admissions rose 1.5% from a year ago. Meanwhile, the total number of days patients stayed increased by 2% as compared to the same period in 2023.” * *
    • “The company also saw net revenue per adjusted admission rise by 7% while net revenue per adjusted patient day increased by 6.5% as compared to the third quarter of 2023. Net revenue from hospital services rose by 9.2% during the third quarter of 2024.
    • “UHS has approximately 96,700 employees and, through its subsidiaries, operates 27 inpatient acute care hospitals and 333 inpatient behavioral health facilities as well 40-plus outpatient facilities and ambulatory care access points. UHS also has an insurance offering and a physician network.”
  • Per Healthcare Dive,
    • “Providence is expanding its presence in the home care market after the nonprofit health system agreed to launch a joint venture this week with home care provider Compassus.
    • “The JV, which will be called Providence at Home with Compassus, will offer home health, hospice, community-based palliative care and private duty caregiving services. 
    • “Compassus will manage operations, according to a press release. The JV will operate 24 home health locations in Alaska, California, Oregon and Washington, and 17 hospice and palliative care locations in Alaska, California, Oregon, Texas and Washington. There’s no timeline yet on when the parties might finalize the proposed JV, and the deal is still pending regulatory review in Oregon.”
  • The Wall Street Journal reports,
    • “AbbVie has agreed to buy Aliada Therapeutics, a biotechnology company backed by Johnson & Johnson, for $1.4 billion in cash in a deal that adds a potential therapy for Alzheimer’s disease to AbbVie’s neuroscience pipeline.
    • “AbbVie on Monday said Aliada’s lead investigational asset, ALIA-1758, is an anti-pyroglutamate amyloid beta antibody that uses a novel blood-brain barrier-crossing technology and is in development for the treatment of the memory-robbing disease.” * * *
    • “The deal is slated to close by the end of the year.”

Weekend Update

David Ermer–CMS, Congress, FDA, Medical / Rx research, Medicare, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Congress remains on the campaign trail until the lame duck session begins November 12.
  • On October 7, the Supreme Court invited the Solicitor General to file a brief in a Tenth Circuit ERISA preemption case, Mulready v. PCMA, No. 23-1213, expressing the views of the United States. The case bears on FEHB preemption of state PBM laws regulating PBM contracts with FEHB carriers. Because the national election will result in a new President on January 20, 2024, it’s likely that the Solicitor General will not submit a brief in this case until next Spring.
  • Beckers Payer Issues offers a useful perspective on HHS OIG and other investigative reports alleging that Medicare Advantage plans game the Medicare program by arranging for plan nurses to visit plan members to conduct health risk assessments.
    • “In a statement published Oct. 24, Mary Beth Donahue, president and CEO of the Better Medicare Alliance, said the report “paints a misleading picture of in-home health assessments.” 
    • “The Better Medicare Alliance is backed by major insurers. 
    • “Medicare Advantage is designed to achieve a better overall understanding of individuals’ health, and in-home assessments are a crucial part of this model,” Ms. Donahue said. “This information ensures seniors get the resources they need. We have supported codified best practices for these assessments and will continue to do so.” 
    • “In an Oct. 24 statement, AHIP, the trade association representing insurers, said CMS did not concur with key recommendations in the OIG’s report. 
    • “The agency did not concur with recommendations from the OIG to restrict payments for diagnoses found during in-home visits. 
    • “In its statement, AHIP said that health risk assessments are “one of many tools” MA plans use to identify chronic conditions and prevent these conditions from becoming more serious. 
    • “Whether they occur in the patient’s home or in a clinical office setting, the HRA offers an opportunity for the health plan and provider to obtain a complete evaluation of the patient’s physical, behavioral, and mental health needs, medications, health risks, and environmental factors that affect health,” the association said.” 
  • Cardiovascular Business tells us,
    • “Medtronic has received U.S. Food and Drug Administration (FDA) approval for its new Affera mapping and ablation system with the Sphere-9 catheter, an all-in-one electrophysiology offering capable of pulsed field ablation (PFA) and radiofrequency (RF) ablation. The system was approved to treat persistent atrial fibrillation (AFib) and cavotricuspid isthmus-dependent atrial flutter. It previously received CE mark approval in March 2023.
    • “Medtronic is now the first company to offer two FDA-approved PFA systems for the treatment of AFib. The company’s PulseSelect PFA system gained FDA approval in December 2023. 
    • “The Sphere-9 catheter at the heart of this system includes a 9 mm lattice tip designed to deliver wide-area circumferential ablations. It can provide either pulsed field or RF energy, a feature that puts more treatment options at the fingertips of operators than other commercially available PFA offerings. 
    • “The significance of this innovative technology should be underscored; Affera is a game changer for treatment of AFib and atrial flutter,” Vivek Reddy, MD, director of cardiac arrhythmia services for the Mount Sinai Health System in New York City and a known leader in ablation technologies, said in a statement. “The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of AFib.”

From the public health and medical research front,

  • The AP reports,
    • “McDonald’s announced Sunday that Quarter Pounders will again be on its menu at hundreds of its restaurants after testing ruled out beef patties as the source of the outbreak of E. coli poisoning tied to the popular burgers that killed one person and sickened at least 75 others across 13 states.
    • “The U.S. Food and Drug Administration continues to believe that slivered onions from a single supplier are the likely source of contamination, McDonald’s said in a statement. It said it will resume selling the Quarter Pounder at affected restaurants —- without slivered onions — in the coming week.
    • “As of Friday, the outbreak had expanded to at least 75 people sick in 13 states, federal health officials said. A total of 22 people had been hospitalized, and two developed a dangerous kidney disease complication, the Centers for Disease Control and Prevention said. One person has died in Colorado.”
  • Fortune Well identifies 17 factors that may play a role in whether a person suffers a stroke.
    • Stroke rates are rising, with over half a million Americans having a first stroke every year. But up to 80% of strokes may be preventable, which is why it’s so important to understand and mitigate your risk factors.
    • That’s according to the American Stroke Association, which this week released its first new clinical guidelines for strokes in a decade. 
  • Fortune Well also shares four lessons about “leadership, parenting, and setbacks” that the UPS Stores president learned from suffering a severe heart attack at age 47.
    • “Sarah Casalan remembers several clear details from the night of her heart attack two years ago: First, she kept thinking she had indigestion from the hamburger she’d made herself for dinner the night before, though it was unusual, considering her “iron stomach.” But then she felt so awful that she lay on the bathroom floor, sweaty and nauseous, for over an hour—and found she could not get up.
    • “That was when the alarm bells went off, though I couldn’t, even at that moment, imagine I was having a heart attack,” says Casalan, president of the UPS Store Inc. and a single mom to two boys who were 6 and 7 at the time. After all, she was just 47, active, and in generally good health. “And why would I think I was having a heart attack without chest pain?” 
    • “Casalan eventually got herself up and to her mom, who happened to be visiting that night, and from there “it was a total of about five minutes between the realization that I could be having a heart attack to unconsciousness.” Turns out she was suffering from full blockage in her left ascending artery—prompting a heart attack known as a “widowmaker”—which has just a 12% survival rate outside of hospitals for women. (Doctors have since theorized that it could’ve been brought on by having had an “overly inflamed” heart after a bout with COVID.)”
  • Per Medscape,
    • “A new study provides real-world evidence to support the potential repurposing of glucagon-like peptide 1 receptor agonists (GLP-1 RAs), used to treat type 2 diabetesand obesity, for prevention of Alzheimer’s disease (AD). 
    • “Adults with type 2 diabetes who were prescribed the GLP-1 RA semaglutide had a significantly lower risk for AD compared with their peers who were prescribed any of seven other antidiabetic medications, including other types of GLP-1 receptor–targeting medications. 
    • “These findings support further clinical trials to assess semaglutide’s potential in delaying or preventing AD,” the investigators, led by Rong Xu, PhD, with Case Western Reserve School of Medicine, Cleveland, Ohio, write. 
    • “The study was published online on October 24 in Alzheimer’s & Dementia.”
  • and
    • “For patients with metabolic dysfunction–associated steatotic liver disease (MASLD) and diabetes, treatment with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) may protect against progression to cirrhosis and mortality; however, the protective benefits do not extend to patients who already have cirrhosis, a new study found.”
  • The Wall Street Journal reports,
    • “Imagine being able to control a computer with your thoughts—even more easily and quickly than using your hands. That is the goal of Precision Neuroscience. Using brain-computer interfaces, it aims to transform the lives of people with physical challenges.
    • “The Wall Street Journal’s Rolfe Winkler spoke with Michael Mager, co-founder and chief executive of Precision Neuroscience, and Benjamin Rapoport, the company’s co-founder and chief science officer. [The article provides] edited excerpts of their discussion at the annual WSJ Tech Live conference.

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “HCA Healthcare took a $50 million financial hit in the third quarter due to the impacts of the back-to-back hurricanes Helene and Milton, which slammed facilities in North Carolina, Georgia and Florida.
    • “The for-profit health system told investors on Friday morning that it expects to feel the effects of the two storms in the fourth quarter as well, with additional hurricane-related costs likely to be between $200 million and $300 million, according to a press release.
    • “HCA noted that these projections do not account for insurance recoveries it may receive.” 
  • ‘Beckers Payer Issues tell us,
    • “Eighteen insurers have exited Medicare Advantage markets for 2025, with more than 1.8 million people currently enrolled in plans that will not exist next year, according to OliverWyman.
    • “Market exits by Humana, Aetna, and UnitedHealthcare collectively affect nearly 70% of those 1.8 million individuals.
    • “It’s important to highlight that these plan exits reflect members who will not be automatically moved into other products, even if one was available,” OliverWyman analysts wrote. “While these plan exits may seem alarming, carriers in many of these markets have introduced new products or have other products that members can switch to for 2025.”
  • Per Beckers Hospital Review,
    • ‘U.S. Bankruptcy Court Judge Christopher Lopez approved the sale of seven Dallas-based Steward Health Care hospitals to Healthcare Systems of America, an affiliate of Glendale, Calif.-based American Healthcare Systems during an Oct. 25 court hearing.
    • “Steward sought Chapter 11 protection May 6 and has been working to sell its 31 hospitals.
    • “The Steward hospitals are Houston-based St. Joseph Medical Center, Port Arthur-based Medical Center of Southeast Texas, Coral Gables (Fla.) Hospital, Hialeah (Fla.) Hospital, Miami-based North Shore Medical Center, Lauderdale Lakes, Fla.-based Florida Medical Center and Hialeah, Fla.-based Palmetto General Hospital. 
    • “Healthcare Systems of America has been interim manager of the hospitals and Steward’s West Monroe, La. -based Glenwood Regional Medical Center since Sept. 11.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy and law enforcement front,

  • Federal News Network tells us,
    • “The White House’s lead regulatory office is reviewing a proposed rule that would upgrade the cybersecurity protections required under the Health Insurance Portability and Accountability Act (HIPAA).
    • “The White House Office of Information and Regulatory Affairs (OIRA) received the proposed rule on Oct. 18.
    • The changes to the HIPAA security rule will “improve cybersecurity in the health care sector by strengthening requirements for HIPAA regulated entities to safeguard electronic protected health information to prevent, detect, contain, mitigate, and recover from cybersecurity threats,” according to a rule abstract published by OIRA.
    • “OIRA is charge of reviewing major agency rulemakings before they are published. Once the HIPAA updates clear White House review, the Department of Health and Human Services would be able to release the Notice of Proposed Rulemaking for public comment.”
  • Here’s the entry in reginfo.gov
    • AGENCY: HHS-OCR. RIN: 0945-AA22. Status: Pending Review. Request EO Meeting
      TITLE: Proposed Modifications to the HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information
      STAGE: Proposed Rule. SECTION 3(f)(1) SIGNIFICANT: Yes. RECEIVED DATE: 10/18/2024
      LEGAL DEADLINE: None  
  • Fedscoop tells us,
    • “The Biden administration published its anticipated national security memo on artificial intelligence Thursday, establishing a roadmap that aims to ensure U.S. competitiveness with adversaries on the technology, while still upholding democratic values in its deployment. 
    • “Specifically, the memo details more responsibilities for the Department of Commerce’s AI Safety Institute, directs agencies to evaluate models for risks and identify areas in which the AI supply chain could be disrupted, outlines actions to streamline acquisition of AI used for national security, and defines new governance practices for federal agencies through a new framework.
    • “In remarks on the memo delivered Thursday at National Defense University, National Security Advisor Jake Sullivan highlighted the potential AI has for the country’s national security advantage but spoke in dire terms about taking action.
    • “The stakes are high,” Sullivan said. “If we don’t act more intentionally to seize our advantages, if we don’t deploy AI more quickly and more comprehensively to strengthen our national security, we risk squandering our hard-earned lead.”
  • Per a NIST announcement,
    • “NIST has released an initial public draft (ipd) revision of Special Publication (SP) 800-131A, Transitioning the Use of Cryptographic Algorithms and Key Lengths.
    • “NIST provides cryptographic key management guidance for defining and implementing appropriate key-management procedures, using algorithms that adequately protect sensitive information, and planning for possible changes in the use of cryptography because of algorithm breaks or the availability of more powerful computing techniques. This publication provides guidance on transitioning to the use of stronger cryptographic keys and more robust algorithms.
    • “This revision proposes a) the retirement of ECB as a confidentiality mode of operation and the use of DSA for digital signature generation and b) a schedule for the retirement of SHA-1 and the 224-bit hash functions. This draft also discusses the transition from a security strength of 112 bits to a 128-bit security strength and to quantum-resistant algorithms for digital signatures and key establishment.
    • “The public comment period is open through December 4, 2024. See the publication details for a copy of the draft and instructions for submitting comments.”
  • The Wall Street Journal reports,
    • “Four tech companies settled federal cases over allegations they misled investors about the extent to which they were compromised in the 2020 SolarWinds hack. 
    • “Avaya Holdings, Check Point Software Technologies, Mimecast and Unisys didn’t admit wrongdoing in separate deals with the U.S. Securities and Exchange Commission, which found their financial disclosures played down what the companies knew about how their systems were affected by breached SolarWinds software. 
    • “Unisys agreed to pay a penalty of $4 million, and the other three companies will pay about $1 million each.
    • “In a breach disclosed in 2020, which the U.S. later attributed to Russia, hackers slipped malicious code into software from Austin, Texas-based SolarWinds. Thousands of customers inadvertently downloaded the malware. Moscow has denied involvement.”

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop lets us know,
    • “The Change Healthcare data breach in February affected 100 million Americans, the company told the Health and Human Services Department this week, making it the biggest breach of health care data ever reported to U.S. regulators.
    • “The development is the latest ripple in what was already an unprecedented attack, one in which the company paid a $22 million ransom, resulted in estimated losses of more than $1 billion and attracted the attention of policymakers who have sought new rules for the industry.
    • “Change Healthcare notified HHS about the updated number, with the company previously stating only that “a substantial proportion of people in America” were affected. HHS posted about the new figure it in its own update Thursday. HHS’s Office of Civil Rights is conducting an investigation of the breach.
    • “The previous record for victims of a breach in the sector was the Anthem breach of 2015, which impacted nearly 79 million Americans and resulted in the company paying a $16 million settlement to HHS.”
  • Cybersecurity Dive adds,
    • “Attackers are actively exploiting a critical zero-day vulnerability in Fortinet’s network and security management tool FortiManager, according to security researchers and federal authorities. The earliest exploitation was on June 27, and at least 50 organizations across various industries have been impacted to date, Mandiant said in a Wednesday blog post.
    • “Fortinet disclosed active exploitation of CVE-2024-47575, which has a CVSS score of 9.8, in a security advisory Wednesday. Hours later, the Cybersecurity and Infrastructure Security Agency added the CVE to its known exploited vulnerabilities catalog. Fortinet did not say how many customers are impacted or when it became aware of CVE-2024-47575 and active exploitation.
    • “The exploitation observed thus far appears to be automated in nature and is identical across multiple victims,” Mandiant Consulting CTO Charles Carmakal said in a Wednesday post on LinkedIn. “However, with most mass exploitation campaigns, we often observe targeted follow-on activity at some victims.”
  • Dark Reading informs us,
    • “Russia’s premiere advanced persistent threat group has been phishing thousands of targets in militaries, public authorities, and enterprises.
    • “APT29 (aka Midnight Blizzard, Nobelium, Cozy Bear) is arguably the world’s most notorious threat actor. An arm of the Russian Federation’s Foreign Intelligence Service (SVR), it’s best known for the historic breaches of SolarWinds and the Democratic National Committee (DNC). Lately, it has breached Microsoft’s codebase and political targets across Europe, Africa, and beyond. Russia’s premiere advanced persistent threat group has been phishing thousands of targets in militaries, public authorities, and enterprises.
    • “APT29 embodies the ‘persistent’ part of ‘advanced persistent threat,'” says Satnam Narang, senior staff research engineer at Tenable. “It has persistently targeted organizations in the United States and Europe for years, utilizing various techniques, including spear-phishing and exploitation of vulnerabilities to gain initial access and elevate privileges. Its modus operandi is the collection of foreign intelligence, as well as maintaining persistence in compromised organizations in order to conduct future operations.”
  • Per Bleeping Computer,
    • “Cisco fixed a denial-of-service flaw in its Cisco ASA and Firepower Threat Defense (FTD) software, which was discovered during large-scale brute force attacks against Cisco VPN devices in April.
    • ‘The flaw is tracked as CVE-2024-20481 and impacts all versions of Cisco ASA and Cisco FTD up until the latest versions of the software.
    • “A vulnerability in the Remote Access VPN (RAVPN) service of Cisco Adaptive Security Appliance (ASA) Software and Cisco Firepower Threat Defense (FTD) Software could allow an unauthenticated, remote attacker to cause a denial of service (DoS) of the RAVPN service,” reads the CVE-2024-20481 security advisory.”

From the ransomware front,

  • Dark Reading points out,
    • “Nearly 400 US healthcare organizations have been infected with ransomwarethis fiscal year, compromising private information, disrupting facilities, and putting lives at risk, according to a study released this week.
    • “The average payment that these organizations have reported paying has gone up to roughly $4.4 million and is costing facilities up to $900,000 in downtime, putting healthcare among ransomware’s most lucrative target sectors.
    • “The disruption that healthcare operations face when hit with ransomware attacks doesn’t just affect hospitals either. It also impacts clinics and doctors in adjacent areas, which absorb displaced patients in these emergencies.” * * *
    • According to the study, ransomware has become such a pronounced issue for the healthcare sector because of its track record of complying with the bad actors and making ransom payments. But since these organizations are dealing with literal life and death issues, they are usually willing to pay millions of dollars to avoid any disruption of care and the data that support it.
  • Cyberscoop relates,
    • “Ransomware developers are used to their malware being detected. Once defenses against it have been built, they revise and update their code to circumvent those defenses. Then developers deploy an updated version in renewed attacks, often with increased sophistication, to evade detection and achieve their malicious objectives.
    • “That cycle has started anew with the Qilin ransomware-as-a-service operation, according to a new report from the cybersecurity firm Halcyon about the group’s updated and upgraded variant. 
    • “Researchers at the firm warned Thursday that “Qilin.B” is a “more advanced” ransomware variant that boosted encryption and evasion techniques to the big game hunters’ arsenal.
    • “Qilin.B’s combination of enhanced encryption mechanisms, effective defense evasion tactics, and persistent disruption of backup systems marks it as a particularly dangerous ransomware variant,” the report noted.”
  • Per Cybersecurity Dive,
    • “Ransomware attacks hit at least 30 organizations using SonicWall firewalls running firmware affected by a critical vulnerability the vendor disclosed and patched two months ago, security researchers at Arctic Wolf Labs said Thursday.
    • “SonicWall disclosed and patched the improper access control vulnerability, CVE-2024-40766, which has a CVSS score of 9.3, on Aug. 22. Arctic Wolf Labs said it began observing Akira and Fog ransomware variant intrusions involving the affected SSL VPN feature of SonicWall firewalls in early August.
    • “We have observed a significant increase in activity consistent with attempted intrusions since August, with spikes in activity typically occurring during non-business hours,” Bret Fitzgerald, senior director of global public relations at SonicWall, said Thursday via email.”
  • Bleeping Computer alerts us,
    • “The BlackBasta ransomware operation has moved its social engineering attacks to Microsoft Teams, posing as corporate help desks contacting employees to assist them with an ongoing spam attack.
      “Black Basta is a ransomware operation active since April 2022 and responsible for hundreds of attacks against corporations worldwide.
      “After the Conti cybercrime syndicate shut down in June 2022 following a series of embarrassing data breaches, the operation split into multiple groups, with one of these factions believed to be Black Basta.”

From the cybersecurity defenses front,

  • Cybersecurity Dive reports,
    • “Microsoft Chair and CEO Satya Nadella asked for the board to reduce part of his annual compensation package to account for his role in how the company prepared for malicious cyberattacks that led to an overhaul of its internal security culture. 
    • “Nadella received more than $79 million in total compensation in fiscal 2024, which included a base salary of $2.5 million, about $71.2 million in stock awards and $5.2 million in non-equity incentive plan compensation, according to a filing with the Securities and Exchange Commission. The total included almost $170,000 classified as other compensation. 
    • “However, Nadella “asked the board to consider departing from the established performance metrics and reduce his cash incentive to reflect his personal accountability for the focus and speed required for the changes that today’s cybersecurity threat landscape showed were necessary,” according to a letter included in the filing from the compensation committee at Microsoft.” 
  • Per Bleeping Computer,
    • Apple created a Virtual Research Environment to allow public access to testing the security of its Private Cloud Compute system, and released the source code for some “key components” to help researchers analyze the privacy and safety features on the architecture.
    • The company also seeks to improve the system’s security and has expanded its security bounty program to include rewards of up to $1 million for vulnerabilities that could compromise “the fundamental security and privacy guarantees of PCC.”
    • Private Cloud Compute (PCC) is a cloud intelligence system for complex AI processing of data from user devices in a way that does not compromise privacy.
  • Cybersecurity Dive shares Gartner’s four ways AI could impact employees, workflows.
  • Here is a link to Dark Reading’s CISO Corner.
  • An ISACA commentator discusses “How the Emerging Technology Landscape is Impacting Cybersecurity Audits.”
  • “In a conversation with The Regulatory Review, Penn Medicine Chief Privacy Officer Lauren Steinfeld discusses how health care systems work to comply with regulations on data privacy.”
  • Tripwire shares “Advanced Tips for Leveraging the NIST Cybersecurity Framework for Compliance.”

Friday Factoids

David Ermer–ACA, CDC, CMS, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, U.S. Healthcare–

From Washington, DC

  • NBC 10 Buffalo NY reports
    • Capital District Physicians’ Health Plan (CDPHP) will no longer be offering its plan for Federal Government employees. A spokesperson for CDPHP said this affects about 6,000 members.
    • “At the beginning of 2024, due to compounding regulations and rising administrative costs, CDPHP made the difficult decision to exit the Federal plan at the end of this plan year,” said the spokesperson. “Federal plan employees will need to select a new plan/carrier during this year’s Open Season.”
    • The FEHBlog remembers an OPM FEHB carrier conference which featured a CDPHP speaker due to the quality of the Plan’s services.
    • OPM does pile benefit and administrative costs on FEHB carriers. The straw that may have broken the camel’s back was OPM’s January 2023 mandate to cover GLP-1 drugs for obesity. That unexpected cost still reverberates in FEHB premiums today.
    • The FEHBlog is not saying that OPM should not have mandated GLP-1 drugs for obesity. The FEHBlog is saying that OPM should have put that mandate in a call letter for benefit and rate proposals so that plans could build the cost into their premiums as federal procurement law requires.
  • The OPM Inspector General weighed in again on the Postal Service Health Benefits Program implementation process.
  • The Miller and Chevalier law firm lets us know,
    • “On October 17, 2024, the Internal Revenue Service (IRS) issued Notice 2024-75 to expand preventive care benefits permitted by a high deductible health plan (HDHP) under section 223(c)(2)(C) of the Internal Revenue Code. The guidance states that over-the-counter (OTC) contraceptives and male condoms, types of breast cancer screenings beyond mammography, and certain types of diabetes care all qualify as preventive care.” * * *
    • “Notice 2024-75 is generally effective for plan years that begin on or after December 30, 2022.”
    • “In related concurrent guidance, the IRS issued Notice 2024-71, which provides a safe harbor for amounts paid for condoms by use by the taxpayer, spouse, or dependent under section 213(d) of the Code. “
  • The American Hospital Association tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 25 launched a preview of health coverage options available through the Open Enrollment Period for the HealthCare.gov marketplaces, set to open on Nov. 1. The Administration also announced Deferred Action for Childhood Arrivals recipients will be eligible to enroll in a marketplace plan and may be eligible for other benefits to lower health insurance out of pocket costs. As part of this year’s open enrollment, CMS updated the HealthCare.gov webpage and made it mobile-friendly to ease the enrollment process. The ACA marketplace open enrollment runs from Nov. 1 to Jan. 15.”
  • Here is a link to the related CMS fact sheet.
  • Per JD Supra,
    • “On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health programs for medically unnecessary urine drug tests and provided illegal kickbacks to physicians.
    • “Precision Toxicology, headquartered in San Diego, CA, is one of the nation’s largest urine drug testing laboratories. According to the fact recitation in the settlement documents, Precision allegedly submitted false claims for drug tests to Medicare, Medicaid, TRICARE, the Federal Employees Health Benefits Program (FEHBP), and the Department of Veterans Affairs (VA) for a period of approximately 10 years. The drug test claims submitted to the programs were allegedly medically unreasonable and unnecessary. Specifically, Precision allegedly utilized nonallowable blanket orders for urine drug tests without physician authorization and offered free point-of-care drug test cups to physicians in exchange for referrals, in violation of the Anti-Kickback Statute.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is declining in most areas. Minimal seasonal influenza activity is occurring nationally. Signs of increased RSV activity have been detected in the southeastern United States, particularly in young children. Respiratory infections caused by the bacterium Mycoplasma pneumoniae have increased in the United States, especially in young children.
    • “COVID-19
      • “Nationally, COVID-19 activity has continued declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels. Nationally, COVID-19 infections are predicted to be growing slowly from a low level.
      • “The XEC variant is predicted to increase to 14-22% among circulating viruses as of October 26, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity is low. However, signs of increased RSV activity have been detected in the southeastern U.S., particularly in young children.
    • “Vaccination
  • The University of Minnesota’s CIDRAP adds,
    • Wastewater detections [of the COVID virus] remain at low levels nationally, but detections tracking a bit higher in the West and Midwest compared to other regions, according to CDC data. Similarly, WastewaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, said its monitoring has the nation at the medium level, with a downward trend over the past 3 weeks. It said the South and West are now in the low category.
  • The Food and Drug Administration informs us,
    • “Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. McDonald’s has temporarily stopped using Quarter Pounder slivered onions and beef patties in affected states. Diced onions and other types of beef patties used at McDonald’s have not been implicated in this outbreak. Additionally, Taylor Farms has initiated a voluntary recall of some onions sent to food service customers. Customers who are impacted have been contacted directly. As of Oct. 24, 75 people infected with the outbreak strain of E. coli O157:H7 have been reported from 13 states. Illnesses started on dates ranging from Sept. 27, 2024, to Oct. 10, 2024. Of 61 people with information available, 22 have been hospitalized and two people developed hemolytic uremic syndrome, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. Of the 42 people interviewed, all 42 (100%) report eating at McDonald’s and 39 people report eating a beef hamburger. Consumers who have already eaten at McDonald’s and have symptoms of E. coli infection should contact their health care provider to report their symptoms and receive care immediately. The FDA is working closely with the U.S. Department of Agriculture, the Food Safety and Inspection Service, the Centers for Disease Control and Prevention and state partners to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. Additional information will be published in the advisory as it becomes available.” 
  • The American Medical Association offers “top health tips that pediatricians want parents to know.”
  • Per Fierce Pharma,
    • “Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem.
    • “Sulopenem, which will now go by the commercial moniker Orlynvah, was approved by the FDA Friday to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative antibacterial treatment options.
    • “The FDA nod—Iterum’s first—marks the second approval this year for a uUTI medicine after two decades of stagnation in the field. It also represents the first U.S. approval for an oral penem—a class of antibiotics.
    • “Back in April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam). The penicillin antibiotic underpinning Utility’s drug had never before been cleared in the U.S., despite being approved in Europe for more than 40 years.”
  • Medscape tells us,
    • “The incidence of atrial fibrillation (AF) is on the rise, and recent joint guidelines from the American College of Cardiology and American Heart Association (ACC/AHA) stress the role of primary care clinicians in prevention and management.
    • “One in three White and one in five Black Americans will develop AF in their lifetime, and the projected number of individuals diagnosed with AF in the United States is expected to double by 2050.
    • “Cardiologists who spoke to Medscape Medical News said primary care clinicians can help control AF by focusing on diabetes and hypertension, along with lifestyle factors such as diet, exercise, and alcohol intake.
    • “It’s not just a rhythm abnormality, but a complex disease that needs to be addressed in a multidisciplinary, holistic way,” said Jose Joglar, MD, a professor in the Department of Internal Medicine at the UT Southwestern Medical Center in Dallas and lead author of the guidelines.
    • Joglar said primary care clinicians can play an important role in counseling on lifestyle changes for patients with the most common etiologies such as poorly controlled hypertension, diabetes, and obesity.”
  • STAT News lets us know,
    • “For people with obesity, surgeries that shrink, reshape, or otherwise alter the anatomy of the stomach have long reigned supreme as the surest way to weight loss. But in the last few years, with the approval of GLP-1 drugs like Wegovy and Zepbound, more and more people are opting for obesity medicines over gold-standard surgical treatments. 
    • “On a population level, among a subset of commercially insured individuals, that is the tradeoff that is happening” said Thomas Tsai, the lead author of a new study that looked at health records of 17 million privately insured Americans with obesity. It found that between 2022 and 2023, as prescriptions for GLP-1 drugs more than doubled, rates of bariatric surgery fell by 25.6%.
    • “The findings, published Wednesday in JAMA Network Open, mark a sharp turnaround from trends over the last decade, and spell an uncertain future for hospitals and clinics that derive a significant portion of their revenues from such procedures.”

From the U.S. healthcare business front

  • Beckers Payer Issues relates,
    • “Centene reported $713 million in net income in the third quarter, per its earnings report published Oct. 25.
    • “Total revenues in the third quarter were $42 billion, up 10.5% year over year.
    • “Total net earnings in the third quarter were $713 million, up 52% since the same period last year.
    • “The company reaffirmed its year-end adjusted EPS guidance of greater than $6.80.
    • ‘The company’s medical loss ratio was 89.2% in the third quarter and 87% during the same period last year.”
  • Per Healthcare Dive,
    • “Medicaid payment rates have yet to catch up with rising costs in the safety-net insurance program. However, conservative planning — along with business growth — yielded a surprisingly positive third quarter for health insurer Molina, according to analysts.
    • “Molina beat Wall Street expectations for earnings and revenue with a topline of $10.3 billion in the quarter, up 21% year over year, thanks in part to higher premiums. Profit of $326 million was up 33% year over year.
    • “Molina appears to be “beating the odds again” in Medicaid, Jefferies analyst David Windley said in a note on the payer’s results.”
  • Beckers Hospital Review points out that “Nashville, Tenn.-based HCA Healthcare posted an operating income of $1.9 billion (10.9% operating margin) in the third quarter of 2024, up from an operating income of $1.6 billion (10.1% margin) over the same period last year, according to its Oct. 25 financial report.”
  • Per MedTech Dive,
    • “Baxter plans to restart its highest throughput manufacturing line for IV solutions within the next week, “barring any unanticipated developments,” the company said on Thursday.
    • “Baxter is working to restore production at a North Carolina plant that makes about 60% of the U.S. supply of IV fluids, and is an important supplier of peritoneal dialysis solutions, according to the American Hospital Association.
    • “The company still has not shared a timeline for restoring full production at the facility after it was flooded by Hurricane Helene in early October. Baxter’s goal is to begin resuming production in phases by the end of the year.”
  • The Washington Post offers an interview with JC Scott, president and CEO of the Pharmaceutical Care Management Association (PCMA), the PBM trade association.
  • Beckers Payers Issues shares executive opinions on “opportunities payers can seize next year.”
  • Per Healthcare Dive,
    • “Cost management company MultiPlan is facing yet another lawsuit for allegedly conspiring to underpay providers — this time, from the largest physician association in the United States.
    • “The American Medical Association’s complaint, filed Thursday in an Illinois district court, accuses MultiPlan of colluding with major health insurers to set artificially low reimbursement rates for out-of-network care, forcing providers to accept payments that often don’t cover their operating costs.
    • “The litigation, which asks the judge for an injunction requiring MultiPlan to halt the illegal practices, is the latest in a long string of suits against the company. Congress is also scrutinizing MultiPlan, which denies the allegations.”

Thursday Miscellany

David Ermer–Uncategorized–

From Washington, DC

  • OPM’s supplemental Postal Service Health Benefits Program final rule was published in the Federal Register today.
  • The FEHBlog is disappointed that OPM is pursuing a modified version of its Part D opt out penalty when 2025 Medicare Part D benefits are so obviously generous. Everyone should put more effort into promoting the advantages of 2025 Part D benefits, e.g., $2000 out of pocket maximum.
  • The FEHBlog also is disappointed that OPM is declining to share Medicare coordination of benefits information, such as Medicare beneficiary identifiers, with FEHB and PSHB carriers when for 35 years the FEHB Act has required OPM in combination with HHS to provide carriers with a Medicare coordination of benefits database. 5 U.S.C. Sec. 8910(d).
  • Govexec encourages federal employees to consider enrolling in a high deductible FEHB plan for 2025 so that they can enjoy the triple tax-free benefits of a health savings account.
  • Reg Jones writing in FedWeek discusses vesting in the federal retirement system.
  • Per an HHS press release,
    • Today, HHS Secretary Xavier Becerra released the following statement in response to new fluid supply increases from Baxter, Inc.:
    • “I am encouraged by reports that Baxter anticipates restarting the highest throughput manufacturing line at Baxter’s North Cove facility next week – sooner than originally expected. There’s more to do, including meeting regulatory requirements of the product manufactured on the restarted line, but this is good news for partners and patients. This progress is the result of a strong public-private partnership. We have quickly facilitated the import of product from six facilities around the world. We have made it easier for hospitals to produce their own IV fluid during the shortage. And HHS will continue to use all necessary authorities to bolster supply and mitigate impact to patients. I want to thank everyone for their continued work on this important part of the recovery process.”

From the public health and medical research front,

  • A “USDA/HHS Fact Sheet [explains the new actions that the] Biden-Harris Administration [is taking] * * * to Halt the Spread of Bird Flu, including in California and Washington.
  • The New York Times adds,
    • “A Missouri resident who shared a home with a patient hospitalized with bird flu in August was also infected with the virus, federal officials reported on Thursday.
    • “But symptomatic health care workers who cared for the hospitalized patient were not infected, testing showed. The news eased worries among researchers that the virus, H5N1, had gained the ability to spread more efficiently among people.
    • “Still, the number of human cases is rising in the United States. California said this week that it had confirmed 15 human cases of bird flu. Washington State has reported two poultry workers who are infected and five others presumed to be positive.
    • “There are 31 confirmed cases in the country, but experts have said the figure is likely to be an undercount. “Additional cases may be found as investigations continue,” Dr. Nirav Shah, the principal deputy director of the Centers for Disease Control and Prevention, said at a news briefing on Thursday.”
  • The AP reports,
    • “A California-based produce company was the source of fresh onions linked to a deadly E. coli food poisoning outbreak at McDonald’s, officials with the restaurant chain said Thursday. Meanwhile, other fast-food restaurants — including Taco Bell, Pizza Hut, KFC and Burger King — pulled onions from some menus.
    • “McDonald’s officials said that Taylor Farms, of Salinas, California, sent onions to one distribution facility, which led the fast-food chain to remove Quarter Pounder hamburgers from restaurants in several states. McDonald’s didn’t say which facility it was.
    • “An outbreak tied to the burgers has sickened at least 49 people in 10 states, including a person who died, federal health officials have said. Investigators said they were focused on slivered onions as a potential source of the infections.” * * *
    • “Officials with the U.S. Food and Drug Administration did not confirm that the agency is investigating Taylor Farms. A spokesperson said Thursday that the agency is “looking at all sources” of the outbreak.”
  • ABC News tells us,
    • “Thousands of bottles of a popular antidepressant medication are being recalled due to the presence of what the National Library of Medicine describes as a toxic chemical, according to a notice from the U.S. Food and Drug Administration.
    • “The recall involves the medication duloxetine, which is sold under the brand name Cymbalta, according to the FDA’s notice of the voluntary recall, which began Oct. 10.
    • “Duloxetine is part of a class of drugs known as SNRIs, or selective serotonin/norepinephrine reuptake inhibitors, that are used to treat anxiety, depression and other mood disorders, according to the FDA.”
  • NIH Director, Dr. Monica Bertagnolli, writes in her blog,
    • “You’ve surely seen fruit flies in your kitchen, perhaps hovering around a bowl of citrus fruits or over a glass of wine. While these insects might not seem especially brainy, typical fruit fly behaviors depend on a complex brain that’s wired to solve many of the same problems human brains do. Their nervous systems and brains must pick up on tempting scents and send the right signals through their bodies to move from one place to another to find food. Fruit flies form long-term memories, engage in social interactions with other fruit flies, and navigate over long distances. Though smaller than a poppy seed, the fruit fly brain is packed with hundreds of thousands of neurons and millions of neural connections all wired precisely to make those behavioral feats possible.
    • “Now, a scientific team supported by the NIH Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®, has unveiled the first complete map, or connectome, of every neural connection within the brain of an adult female fruit fly. This important milestone in brain science, reported in nine papers in Nature, details more than 50 million connections between nearly 140,000 neurons. As the first complete map of a connectome of any adult animal, it offers critical information about how complex brains are wired to send and receive signals underlying normal brain functions.” * * *
    • “While there’s still a lot to learn about how the human brain is wired and how it works, the fruit fly connectome serves as an important step toward developing the tools and capabilities required for mapping larger-brained animals and, eventually, the human brain, with its more than 80 billion neurons and 100 trillion connections. The connectome and the many exciting discoveries and developments yet to come will be critical for bringing much needed advances in understanding and one day treating a wide range of human brain disorders, including Alzheimer’s disease, Parkinson’s disease, severe depression, and addiction.”

From the U.S. healthcare business front,

  • Beckers Hospital Review shares information on Health Grade awards for hospital special care.
  • The American Journal of Managed Care informs us,
    • “Value-based care prioritizes patient outcomes and cost reduction, requiring alignment of reimbursement models and financial sustainability management.
    • “Private insurers are reforming payment models, but aligning specialty care with value-based goals remains challenging.
    • “Financial pressures and data integration are key hurdles in transitioning to value-based care, necessitating innovative partnerships.
    • “Educating patients about value-based care options is essential to reduce unnecessary emergency department visits and improve care outcomes.”
  • and
    • “Social determinants of health significantly influence health care costs across Medicare, Medicaid, and private insurance programs.
    • “Educational attainment and social isolation notably affect Medicaid expenditures, with higher costs linked to lower education and increased isolation.
    • “Neighborhood quality and economic stability are key factors in Medicare spending, impacting costs based on access to parks and financial confidence.
    • “Medical discrimination and debt collection contact are associated with increased private insurance expenditures.
    • “Integrating SDOH into policy could help manage healthcare costs and promote health equity, though challenges persist in implementation.”
  • Ken Kaufmann from Kaufmann Hall opines that “Changing American Demographics Make Hospital Operations Harder,” and he offers some ideas to help hospitals out.