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 front,

  • Federal News Network informs us
    • “Vulnerability disclosure policies have proliferated throughout federal agencies in recent years, and if a new House bill ends up becoming law, federal contractors would have to adopt policies for accepting vulnerability information from security researchers as well.
    • “Rep. Nancy Mace (R-S.C.) today announced the Federal Cybersecurity Vulnerability Reduction Act of 2023. Mace is chairwoman of the House Oversight and Accountability Committee’s cybersecurity, information technology and government innovation subcommittee.
    • “The bill would require the White House Office of Management and Budget to lead updates to the Federal Acquisition Regulation that ensure federal contractors implement a vulnerability disclosure policy. * * *
    • “Mace’s bill would have contractors specifically follow the VDP guidelines established by the National Institute of Standards and Technology.
    • “In May, NIST published “Recommendations for Federal Vulnerability Disclosure Guidelines.” The document lays out a federal vulnerability disclosure framework, including information about how agencies should set up a system for receiving information about potential security vulnerabilities, as well as methods for communicating ways to resolve those vulnerabilities to other agencies and the public.

From the cybersecurity vulnerabilities and breaches front,

  • HHS’s Health Sector Cybersecurity Coordination Center released its July 2023 report on vulnerabilities of interest to the health sector.
    • “In July 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for July are from Microsoft, Google/Android, Apple, Mozilla, SAP, Cisco, Fortinet, VMWare, MOVEit, Oracle, and Adobe. A vulnerability is given the classification as a zero-day if it is actively exploited with no fix available or if it is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.”
  • The Cybersecurity and Infrastructure Security Administration added a new known exploited vulnerability to its catalog on August 21; two more on August 22, and another two on August 24.
  • Per Health IT Security,
    • “Healthcare data breaches remain a troubling and frequent occurrence despite an observed dip in the number of breaches reported to HHS in the first six months of 2023, Critical Insight noted in its H1 2023 Healthcare Data Cyber Breach Report.
    • “While the number of breaches dropped 15 percent in the first six months of the year compared to the latter half of 2022, the number of records compromised jumped by 31 percent. As previously reported, nearly 40 million records were implicated in healthcare data breaches reported to HHS from January to June.”

In HIPAA Privacy Rule news,

  • Health IT Security says,
    • “The HHS Office for Civil Rights (OCR) reached a settlement with UnitedHealthcare Insurance Company (UHIC) to resolve potential HIPAA right of access violations. UHIC, a health insurer that provides coverage to millions across the US, agreed to pay $80,000 to OCR to resolve the investigation.
    • “The investigation marks the 45th case settled under OCR’s HIPAA Right of Access Initiative, which was created in 2019 to underscore OCR’s commitment to ensuring that patients have timely access to their medical records.
    • “The UHIC case arose in March 2021, when OCR received a complaint alleging that UHIC had not responded to an individual’s request for a copy of their medical record. The individual requested their records in January 2021, finally receiving them in July 2021, after OCR had initiated its investigation into the matter.”

From the ransomware front,

  • Cybersecurity Dive reports
    • “The median dwell time for ransomware attacks fell in the first half of 2023, down to 5 days from the 2022 average of 9 days, according to Sophos research released Wednesday.
    • “The majority of ransomware attacks are taking place during the work week, yet outside standard business hours, Sophos found. The bulk of 80 cases its incident response team worked on during the first half of 2023 took place between 11 p.m. and 8 a.m. in the target’s time zone. Attackers also strongly favored a “late hour at the end of the week” to launch an attack.
    • “Monitoring and reactions have to be 24/7 these days,” said Chester Wisniewski, field CTO of applied research at Sophos. “The criminals are striking when we’re not sitting at the keyboard waiting for them.”
  • and
  • and
    • “The Rhysida ransomware group claimed responsibility for a ransomware attack against Prospect Medical Holdings that forced multiple hospital closures earlier this month and continues to impact operations.
    • “The threat actor said it stole more than 500,000 Social Security numbers, passport data of clients and employees, patient medical files, and financial and legal documents, according to a Thursday post on the dark web. 
    • “Emsisoft Threat Analyst Brett Callow shared a screenshot of the post on X, the platform formerly known as Twitter, Thursday [August 24].”
  • Bleeping Computers’ The Week in Ransomware is on summer vacation this week.

From the cybersecurity defenses front,

  • Per CISA,
    • “[On August 21,] the Cybersecurity and Infrastructure Security Agency (CISA), National Security Agency (NSA) and National Institute of Standards and Technology (NIST) released a joint factsheet, Quantum-Readiness: Migration to Post-Quantum Cryptography (PQC), to inform organizations—especially those that support Critical Infrastructure—of the impacts of quantum capabilities, and to encourage the early planning for migration to post-quantum cryptographic standards by developing a Quantum-Readiness Roadmap.
    • “CISA, NSA, and NIST urge organizations to review the joint factsheet and to begin preparing now by creating quantum-readiness roadmaps, conducting inventories, applying risk assessments and analysis, and engaging vendors. For more information and resources about CISA’s PQC work, visit the Post-Quantum Cryptography Initiative.”
  • Per Health IT Security,
    • “The Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) issued an updated version of its “Health Industry Cybersecurity Information Sharing Best Practices” guide (HIC-ISBP) to help healthcare organizations craft and maintain a cybersecurity threat information sharing program.
    • “Originally published in March 2020 in partnership with the Health Information Sharing and Analysis Center (Health-ISAC), the document serves to address barriers to information sharing and guide organizations toward overcoming regulatory obstacles that may make information sharing a challenge.
    • “The document is a companion to another recently updated publication known as the “Matrix of Information Sharing Organizations,” which provides healthcare organizations with a list of reputable information-sharing entities.”
  • Dark Reading identifies five best practices for implementing Risk-First Cybersecurity.
    • “Organizations face an uphill battle to safeguard hybrid cloud assets and sensitive data from evolving cyber threats in an increasingly interconnected and digitized world. While the security-first approach is essential, it has limitations in addressing the dynamic nature of these threats. The risks resulting from these threats are multifaceted and sophisticated, encompassing cybersecurity, compliance, privacy, business continuity, and financial implications. Therefore, a shift toward a risk-first approach is necessary.”
  • ISACA shares an executive view of key cybersecurity trends in 2023.
    • “2023 has further proven that the state of cybersecurity is constantly evolving. New technologies are emerging and increasingly being adopted for purposes of enhancing threat detection, analyzing large volumes of data for anomalies and automating security processes. Meanwhile, cyber threats are becoming increasingly sophisticated. In 2022, 76% of organizations were targeted by a ransomware attack, of which 64% were infected.1 To more effectively defend against such attacks, it is important for cyber professionals to understand current trends and challenges that exist in the field of cybersecurity.”
  • The Wall Street Journal offers its quarterly cyber insurance update.
    • In this quarter’s update, we look at new Securities and Exchange Commission cyber rules that may increase insurance risks for corporate directors, how new technologies such as artificial intelligence are helping assess a company’s cyber risk profile, and whether having a cyber insurance policy increases the likelihood of being a victim of a ransomware attack?

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the No Surprises Act front,

  • The American Hospital Association informs us,
    • “The U.S. District Court for the Eastern District of Texas, for a third time, ruled to set aside certain regulations implementing the No Surprises Act. In this case, the Texas Medical Association, joined by several air ambulance providers and supported by an amicus filed by the AHA, successfully argued that the methodology for how insurers calculate the qualifying payment amount tilts the arbitration process in insurers’ favor.” 
  • The Centers for Medicare and Medicaid Services adds,
    • “On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services, Case No. 6:22-cv-450-JDK (TMA III), vacating certain portions of 86 Fed. Reg. 36,872, 45 C.F.R. § 149.130 and 149.140 , 26 C.F.R. § 54.9816-6T and 54.9817-1T, 29 C.F.R. § 2590.716-6 and 2590.717-1, and 5 C.F.R. § 890.114(a) as well as certain portions of several guidance documents. As a result of the TMA III decision, effective immediately, the Departments have temporarily suspended all Federal IDR process operations until the Departments can provide additional instructions. Disputing parties should continue to engage in open negotiation.”
  • The FEHBlog hopes that the federal regulators move to stay this decision pending appeal to the U.S. Court of Appeals for the Fifth Circuit. That court is already reviewing Judge Kernodle’s first decision modifying the final No Surprises Act implementing rule (No. 23-40217).

From Washington, DC —

  • STAT News tells us,
    • “With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different.
    • “In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention [CDC] and the Food and Drug Administration [FDA] detailed the various countermeasures available to combat COVID-19, RSV, and influenza, and discussed the expected timing on the rollouts of these tools. They spoke on condition that their names and titles would not be disclosed.
    • “We are in our strongest position yet to be able to fight COVID-19 as well as the other viruses that are responsible for the majority of fall and winter hospitalizations,” one CDC official said. “We also have more tools, including … for the first time ever, vaccines for all three of the major fall and winter respiratory viruses — influenza, Covid, and RSV. Our goal, our imperative, our task is to make sure we’re using those tools.”
    • “The updated Covid vaccines have not yet been cleared by the FDA, but that must be coming in the next two and a half weeks or so, because a meeting of the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, has been slated for Sept. 12. ACIP must vote on whether to recommend the updated vaccines — and the recommendation must be endorsed by CDC Director Mandy Cohen — before they can begin to be used. The federal officials said the vaccine rollout would begin by mid-September.”
  • The CDC also updated flu vaccine information for the 2023-24 flu season.
  • Per the U.S. Department of Justice,
    • “[On Wednesday, August 23, 2023,] Deputy Attorney General Lisa O. Monaco delivered opening remarks at a roundtable meeting of senior Justice Department officials and investigative partners to announce the results of a coordinated, nationwide enforcement action to combat COVID-19 fraud, which included 718 enforcement actions – including federal criminal charges against 371 defendants – for offenses related to over $836 million in alleged COVID-19 fraud. Deputy Attorney General Monaco also announced the launch of two additional COVID-19 Fraud Enforcement Strike Forces: one at the U.S. Attorney’s Office for the District of Colorado and one at the U.S. Attorney’s Office for the District of New Jersey. These two strike forces add to the three strike forces launched in September 2022 in the Eastern and Central Districts of California, the Southern District of Florida, and the District of Maryland.”

From the medical and Rx research fronts —

  • BioPharma Dive reports,
    • “Two weeks ago, Danish drugmaker Novo Nordisk released results of a large trial showing its weight loss drug Wegovy can help prevent heart attacks and strokes in overweight people with cardiovascular disease. It followed up on those landmark data Friday with further evidence the injectable drug helps protect the heart.
    • “In people with a form of heart failure, Wegovy reduced disease symptoms and improved quality of life and exercise duration by more than placebo, according to results from the trial, codenamed “STEP-HFpEF.” The data were released at the European Society of Cardiology meeting and published in The New England Journal of Medicine.
    • “The newly released data could further help Novo persuade insurers to provide broader coverage for Wegovy, which carries a list price of more than $17,000 a year. Insurers might be more open to offering coverage if they know the shot can avert expensive hospitalizations and episodes of care.
    • “Broad coverage also could help Novo retain its lead over rival Eli Lilly, which has a similarly acting drug Mounjaro that is approved to treat diabetes but not yet weight loss.”
  • MedPage Today points out,
    • A novel 14-year risk score helped identify people from age 50 onward at risk for all-cause dementia, a large U.K. study showed.
    • The tool, called the U.K. Biobank Dementia Risk Score (UKBDRS), was developed and validated in two U.K. cohorts, reported Raihaan Patel, Ph.D., of the University of Oxford in England, and co-authors.

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • Employers will pay more than $15,000 on average for each employee’s healthcare in 2024, according to an analysis from consulting firm Aon. 
    • Employer-sponsored insurance costs will rise 8.5 percent in 2024, up from an average of $13,906 per employee in 2023, according to Aon’s estimates published August 22.
    • Read the full report here.
  • Fortunately, OPM’s decision to allow FEHB carriers to offer Medicare Part D EGWP arrangements in 2024 will offset the factors discussed in the Aon report.
  • Beckers Hospital Review reports,
    • “Ongoing increases in expenses were part of the drive behind lower hospital operating margins in July, according to a Syntellis report.
    • “While such margins remained positive, they contracted for the first time since rising into the black in March, the report showed. The operating margin median for July was 1.1 percent compared to 2 percent in June, but still higher than the March through May period and 2.6 percentage points higher than July 2022.
    • “While overall expenses were up 3.6 percent on the same period in 2022, labor expenses increased 2.1 percent. Supplies and drug costs were both up over 5 percent, the report said.”
  • Per Healthcare Dive,
    • “A new brief from out Wednesday from research firm KFF explores the potential of consumer cost changes and antitrust regulation when healthcare systems engage in cross-market mergers, including a body of research indicating possible healthcare price increases.
    • “Antitrust agencies have historically focused on mergers between hospitals and health systems that operate in the same geographic market, the KFF brief noted. The Federal Trade Commission has never formally challenged a cross-market merger and antitrust agencies have not developed guidelines for evaluating them.
    • “Regulating cross-market mergers, will be “on the radar” of policymakers and regulators as they become increasingly common, KFF said. Between 2010 and 2019, cross-market mergers made up 55% of hospital M&A ventures, and drove at least nine large-scale mergers since June 2021.”

Quick Takes

David Ermer–ACA, CDC, CMS, FDA, Medicare, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Mercer Consulting informs us,
    • “The Affordable Care Act (ACA) benchmark for determining the affordability of employer-sponsored health coverage will drop significantly to 8.39% of an employee’s household income for the 2024 plan year — down from the 2023 plan-year level of 9.12%, according to IRS Rev. Proc. 2023-29. This affordability percentage can affect individuals’ eligibility for federally subsidized coverage from a public exchange, as well as employers’ potential liability for shared responsibility (or “play or pay”) assessments. Importantly, employers that use the exact safe harbor dollar amount to set employee contributions will need to reduce the current employee contribution for the lowest-cost, self-only option for the 2024 plan year.”
  • The Food and Drug Administration has “approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).”
  • Per the American Hospital Association
    • The Centers for Disease Control and Prevention Aug. 24 announced the launch of its Hospital Sepsis Program Core Elements initiative, a new program to provide hospitals with a blueprint for managing medical emergencies stemming from sepsis. The program, which is modeled after a similar effort for antibiotic stewardship, is intended as a “manager’s guide” to organizing staff and making the resources available to improve sepsis care and bring survival rates up.”
  • CMS tells us that
    • “The Medicare Shared Savings Program saved money for Medicare while continuing to support high-quality care. Specifically, the program saved Medicare $1.8 billion in 2022 compared to spending targets for the year. This marks the sixth consecutive year the program has generated overall savings and high-quality performance results. This represents the second-highest annual savings accrued for Medicare since the program’s inception more than ten years ago.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • Cigna is the latest health insurer to roll back prior authorization requirements, announcing Thursday that it will no longer require the approvals for nearly 25% of medical services.
    • Cigna plans to remove more than 600 prior authorization codes in its commercial plans, bringing Cigna’s total prior authorization removals to more than 1,100 since 2020, the payer said.
    • Cigna plans to nix another 500 or so codes for its Medicare Advantage plans before the end of this year.

Midweek update

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC –

  • STAT News informs us,
    • “The Centers for Disease Control and Prevention said Wednesday it’s too early to tell whether a new version of the SARS-CoV-2 virus that has triggered some international concern will actually prove to be disruptive.
    • “In a preliminary statement about the BA.2.86 subvariant, the CDC also revealed that updated Covid-19 vaccines should be available across the country as early as mid-September, earlier than previous estimates have placed the start of the fall booster campaign.
    • “The vaccines, made by Pfizer, Moderna, and Novavax, must first be authorized by the Food and Drug Administration and recommended by the CDC’s expert vaccine panel, the Advisory Committee on Immunization Practices, and the CDC itself. The three manufacturers have said they have doses at the ready for when the FDA and CDC sign-offs come.”
  • The National Institutes of Health announced,
    • “An international research team has generated the first truly complete sequence of a human Y chromosome, the final human chromosome to be fully sequenced. The new sequence, which fills in gaps across more than 50% of the Y chromosome’s length, uncovers important genomic features with implications for fertility, such as factors in sperm production. The study, led by the Telomere-to-Telomere (T2T) Consortium, a team of researchers funded by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, was published today in Nature.”
  • Levita Magnetics, “whose mission is to help more patients get access to better surgery,” tells us,
    • “U.S. Food and Drug Administration (FDA) gave Levita clearance for its MARS™ platform.
    • “The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. Harnessing the power of both magnets and machines, MARS reduces the number of incisions and enables surgeons to have complete control during laparoscopic procedures, all in a compact footprint designed to fit into existing operating rooms.
    • “Building on the success of its first commercial product, the Levita Magnetic Surgical System®, Levita designed MARS to deliver the same patient benefits as Magnetic Surgery®, while empowering surgeons with increased control of surgical instruments and providing an efficient way for hospitals and ambulatory surgery centers (ASCs) to incorporate this new technology.”

From the public health front,

  • Ovia Health released a white paper “externally validating Ovia’s preterm birth reduction programming.
  • STAT News discusses steps being taken to cure a “severe shortage of doctors who actually specialize in treating obesity” in the United States.
    • “To ensure that all 115 million Americans with obesity have access to care, the field should focus on empowering primary care providers to treat “simple obesity,” or uncomplicated cases, said Kimberly Gudzune, medical director of the American Board of Obesity Medicine. “That, hopefully, prevents the development of some of the complications.”
    • “And this work begins in medical school and residency. For instance, [Juliana] Simonetti [,an obesity doctor at the University of Utah,] has proposed a one-month elective course on obesity at the University of Utah School of Medicine, and Freshwater has been working with the Obesity Medicine Association to incorporate education into training programs nationwide, including the local family medicine residency in Boise.”

From the Rx coverage front,

  • BioPharma Dive points out,
    • “A closely watched, experimental Roche medicine may be helping lung cancer patients live longer, spurring renewed optimism about an emerging class of immunotherapy treatments.
    • “The data come from an interim analysis of a Phase 3 trial pairing the drug, tiragolumab, with a marketed Roche immunotherapy called Tecentriq in patients with non-small cell lung cancer. Roche completed the analysis in February, but never publicly disclosed its findings, which were inadvertently released on its website Tuesday night and discovered by Wall Street analysts. The company is expected to provide the final study results either late this year or early next.”
  • Per Fierce Healthcare,
    • “CVS Health has launched a new segment that aims to work with drugmakers to bring additional biosimilars to market.
    • “The new, wholly owned subsidiary, called Cordavis, aims to develop a biosimilar portfolio with the goal of expanding access to these drugs across the country. Increased uptake of biosimilars can drive down costs of pricey brand drugs that otherwise lack market competition, CVS said.”

From the U.S. healthcare business front,

  • Forbes delves into Amazon’s recently expanded Amazon Clinic product.
    • “With Amazon Clinic, one of the world’s biggest technology companies is looking to infuse the black box of healthcare pricing with some actual transparency. Login to the site and you’ll see that a person who tests positive for Covid-19 in Wyoming can pay $35 for a message-based conversation with a doctor, who will respond within an hour and 45 minutes. Or $40 to get a response in 30 minutes. A video visit costs $74 with a wait time of around an hour and 30 minutes.
    • “Amazon isn’t directly providing the medical services. Instead, the tech giant has contracted with four different startups to provide message and video appointments for around 30 medical conditions. The result is a dynamic marketplace where customers can see pricing, wait times and the typical number of prescription refills upfront. “If you want the lower cost provider, you can choose that. If you are actually prioritizing the speed at which someone is getting back to you, you can prioritize that as well,” Nworah Ayogu, chief medical officer and general manager of Amazon Clinic tells Forbes. “We think really being able to surface different options for different customers lets them choose what’s important to them.”
  • Per Fierce Healthcare,
    • “Most Americans support the idea of value-based care but don’t understand or resonate with the term, according to new research from United States of Care. 
    • “USofCare is a self-described nonpartisan think tank focused on building a more equitable healthcare system. Its latest research relied on (PDF) virtual focus groups with a dozen participants, a national survey that reached 1,000 respondents and a “ReMesh” session, or an AI-driven feedback collection platform that engaged 100 participants more deeply.”

Tuesday Tidbits

David Ermer–CDC, Electronic health records, FDA, Generative AI, Medicare, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healio informs us,
    • “An FDA panel voted that for adults with uncontrolled hypertension, the benefits of an ultrasound renal denervation device outweigh its risks.
    • Concerns about long-term durability of effect were expressed.”
  • The Department of Health and Human Services announced
    • “award[ing] more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19 for years to come.
    • “The awards announced today follow extensive coordination with industry partners and include support for clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes.”
  • The U.S. Preventive Services Task Force reaffirmed its 2019 Grade A recommendation that “clinicians prescribe preexposure prophylaxis using effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV.”
  • The Centers for Disease Control lets us know, based on a survey,
    • About 20% of women reported mistreatment while receiving maternity care.
    • About 30% of Black, Hispanic, and multiracial women reported mistreatment. 
    • Almost half (45%) of women held back from asking questions or sharing concerns during their maternity. * * *
    • Mistreatment was reported most often by Black, Hispanic, and multiracial moms and those with public insurance or no insurance.
  • That’s a big bowl of wrong. The CDC observes,
    • Respectful maternity care is free from harm and mistreatment, maintains privacy, confidentiality, and dignity, and allows for shared decision-making and continuous support.
  • The Department of Justice announced yesterday,
    • [“D]eferred prosecution agreements resolving criminal antitrust charges against Teva Pharmaceuticals USA, Inc. and Glenmark Pharmaceuticals Inc., USA. As part of those agreements, both companies will divest a key business line involved in the misconduct, and as an additional remedial measure, Teva will make a $50 million drug donation to humanitarian organizations. Teva will pay a $225 million criminal penalty — the largest to date for a domestic antitrust cartel — and Glenmark will pay a $30 million criminal penalty. Both companies will face prosecution if they violate the terms of the agreements, and if convicted, would likely face mandatory debarment from federal health care programs.
    • “The agreements each require the companies to undertake remedial measures, including the timely divestiture of their respective drug lines for pravastatin, a widely used cholesterol medicine that was a core part of the companies’ price-fixing conspiracy. This extraordinary remedy forces the companies to divest a business line that was central to the misconduct. Teva must also donate $50 million worth of clotrimazole and tobramycin, two additional drugs with prices affected by Teva’s criminal schemes, to humanitarian organizations that provide medication to Americans in need. Both Teva and Glenmark have agreed, among other things, to cooperate with the department in the ongoing criminal investigations and resulting prosecutions, report to the department on their compliance programs, and modify those compliance programs where necessary and appropriate.” 
  • Federal New Network reports that OPM released guidance for hybrid teleworkers who are covered under the Fair Labor Standards Act.
  • The Equal Employment Opportunity Commission released its new strategic plan for fiscal years 2022 through 2026
    • “The new Strategic Plan reflects our thoughtful assessment of the agency’s mission, goals, and objectives in light of current conditions and what we expect in the next few years,” said EEOC Chair Charlotte A Burrows. “It emphasizes expanding the EEOC’s capacity to eliminate systemic barriers to equal opportunity in the workplace, using technology and other tools to improve our services to the public, and achieving organizational excellence with a culture of accountability, inclusivity, and accessibility. I am grateful for the hard work of our staff across the agency who assisted in developing this plan and look forward to its successful implementation.”.

From the public health front,

  • The Washington Post explains
    • how to address the factors that may underlie the growing number of women under age 40 who are afflicted with breast cancer,
  • and
    • how to guard against germs in leafy green salads.

From the U.S. healthcare business front,

  • The FEHBlog was surprised to read in the Wall Street Journal that
    • “America’s nursing homes are fading away.
    • “The U.S. has at least 600 fewer nursing homes than it did six years ago, according to a Wall Street Journal analysis of federal data. More senior care is happening at home, and the Covid-19 pandemic caused many families to shun nursing homes while draining workers from an already short-staffed industry.
    • “The result? Frail elderly patients are stuck in hospitals, a dangerous place for seniors, waiting for somewhere to go—sometimes for months. Beds are disappearing while the need for senior care is growing. The American population 65 and older is expected to swell from 56 million in 2020 to 81 million by 2040.
  • MedPage Today notes.
    • “States that recently adopted less-restrictive policies surrounding the use of telepharmacy had fewer pharmacy deserts in the following year, a cohort study involving a dozen states showed.
    • “Compared with nearby states that made no changes, states that formally implemented or updated pro-telepharmacy policies had a 4.5% relative decrease (95% CI 1.6-7.4) in the percentage of regions defined as pharmacy deserts (P=0.001) and an 11.1% relative decrease (95% CI 2.4-22.6) in the proportion of people living in one of these deserts (P=0.03).
    • “And in general, telepharmacies tended to serve areas of high medical need, reported Jessica Adams, PharmD, of TelePharm in Iowa City, Iowa, and colleagues.
    • “As pharmacy closures and socioeconomic factors persist, pharmacy deserts are likely to expand unless policies are implemented to ensure continued access to pharmacy services,” the researchers wrote in JAMA Network Open
  • The Business Group on Health points out,
    • “Mental health needs among workforces continued to climb this year, with 77% of large employers reporting an increase and another 16% anticipating one in the future, according to Business Group on Health’s 2024 Large Employer Health Care Strategy Survey.
    • “This represents a 33 percentage-point surge over last year, when 44% of employers saw an increase in employee mental health concerns.
    • “The Business Group survey, released today in Washington, DC, also showed that cancer was still the top driver of large companies’ health care costs while rising prescription drug costs also proved to be a leading concern. Cancer overtook musculoskeletal conditions last year as the top driver of large companies’ healthcare costs and shows no sign of abating in the coming years.
    • “Yet as businesses respond to the increase in mental health needs, grapple with soaring health care costs and address issues of health equity and affordability, they will continue to invest strategically in diverse health and well-being offerings for the upcoming year, the survey also showed.”
  • Axios reports that “Middle-class Americans [who earn $50,000 to $100,000 annually] are the most likely to be saddled with medical debt, with nearly 1 in 4 — or roughly 17 million people — having unpaid medical bills, according to a report shared first with Axios from center-left think tank Third Way.”
  • Per Healthcare Dive,
    • “Epic and Microsoft announced on Tuesday an expanded collaboration focused on integrating generative artificial intelligence tools in the vendor’s electronic health records system. 
    • “The partners are working to “rapidly deploy dozens” of AI technologies, including clinical note summarization, medical coding suggestions and data exploration tools that aim to fill gaps in clinical evidence by using real-world data. 
    • “The expanded partnership is intended to speed the development of AI tools in healthcare, bringing the technology as “quickly as possible, responsibly and in partnership with providers,” according to a blog post by Eric Boyd, corporate vice president of AI platform at Microsoft.”

Monday Roundup

David Ermer–CMS, FDA, HSA, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • ‘A vaccine that federal regulators approved on Monday could help make the most severe cases of a dangerous respiratory illness in infants a thing of the past. 
    • ‘The Food and Drug Administration approved the first vaccine for pregnant women to protect their babies against respiratory syncytial virus during their first six months. RSV is the leading cause of infant hospitalization in the U.S. and kills as many as 300 children under 5 years old each year. 
    • ‘Pfizer’s vaccine, called Abrysvo, gives parents another way to protect their newborns, after Sanofi’s drug Beyfortus won approval in July. The FDA earlier this year also cleared a pair of RSV shots from Pfizer and GSK to protect older adultsfrom RSV. Until now, most children had to fight off infections on their own. Only babies at high risk for severe disease are eligible for a drug from the company Sobi. 
    • “We’re sort of going from famine to feast,” said Dr. Kristin Moffitt, an infectious-disease specialist at Boston Children’s Hospital. “These are huge game changers for what has typically been the most common cause of hospitalization for young infants in the U.S.” 
  • Health Payer Intelligence relates,
    • “CMS has released draft guidance detailing a new program allowing Medicare beneficiaries to pay out-of-pocket Part D costs in monthly installments.
    • “The Medicare Prescription Payment Plan is required under the Inflation Reduction Act and will take effect in 2025.
    • “The program mandates Medicare Part D plan sponsors to offer Part D beneficiaries the option to pay their out-of-pocket costs for prescription drugs monthly over a year instead of at the point of sale. Part D sponsors must pay the pharmacy the out-of-pocket cost-sharing beneficiaries would have paid if they were not in the program. Sponsors will then bill beneficiaries monthly for the cost-sharing.
    • “The program is available to all Medicare Part D beneficiaries, but CMS indicated that those incurring high out-of-pocket costs earlier in the plan year are more likely to benefit from the payment plan. The agency will develop tools to help beneficiaries decide if the program will be helpful.
    • “While the program will not reduce beneficiaries’ overall out-of-pocket costs, spreading the costs throughout the year can help ease some cost-sharing burden, CMS said. Additionally, beneficiaries will owe $0 upfront when picking up medication at the pharmacy.”

From the public health front,

  • Health Leaders Media tells us,
    • “Innovation in pediatric healthcare often focuses on the tiniest of factors affecting the tiniest of patients. And Tanja Gruber, MD, PhD, says research around the makeup and functions of the gene are enabling care providers to get a better idea of how to tackle cancer.
    • “HealthLeaders recently sat down—virtually—with Gruber, chief of pediatric hematology, oncology, and stem cell transplantation at Stanford Medicine Children’s Health to discuss innovative ideas like immunotherapy, stem cell transplants, gene therapy, and gene editing, and how they’re helping to improve outcomes for millions of children.”
    • Check it out.
  • Per the Washington Post,
    • In a study presented at the annual meeting of the American Society for Nutrition, researchers found that men who had adopted all eight habits by middle age lived 24 years longer than men whose lifestyle included few or none of the habits. Women’s life expectancy increased by 23 years for those who had adopted the eight habits compared with women who had not.
    • The study was based on data from nearly 720,000 U.S. veterans 40 and older, which is considered a nationally representative sample. Described by the researchers as “therapeutic lifestyle factors,” the eight key habits were:
      • Not smoking.
      • Being physically active.
      • Managing stress.
      • Eating a healthy diet.
      • Having good sleep hygiene.
      • Avoiding binge drinking.
      • Not being addicted to opioids.
      • Having positive social relationships.

From the U.S. healthcare business front,

  • STAT News informs us,
    • “To much of the public, the promise of telehealth is all about convenience — get the prescription you need quickly, and get it delivered right to your door. But as digital health companies build out their weight loss businesses, capitalizing on the popularity of drugs like Wegovy and Ozempic, they’re courting a very different audience: payers and employers who have a vested interest in preventing quick scripts.
    • “Payers are reeling as they try to figure out how to sustainably cover GLP-1 receptor agonists, a class of remarkably effective but expensive obesity and type 2 diabetes drugs. So in the last six months, digital health companies, including Teladoc, Found, Hello Alpha, and Calibrate, have advanced enterprise products that pair virtual visits and prescriptions with lifestyle coaching. Their hope is that more and more payers and employers will offer their programs as a way to support lasting weight loss and metabolic health — or even require them if patients want their drugs reimbursed.”

From the human resources front,

  • CFO reports,
    • [A]ccording to a study released on Monday, a newer type of account — “lifestyle spending accounts,” or LSAs — has quickly become the most common employer-funded perquisite. (Unlike FSAs and HSAs, LSAs are categorized as perks because they’re funded solely by employers and are considered taxable income for employees.) * * *
    • LSAs differ from HSAs and FSAs in another key respect — employees can use them for many types of spending needs, as determined by the employer. These could include health-related purchases such as gym memberships, nutritionists, and health-care coaching, as well as spending on, for example, learning and development, family activities, commuting, pets, or charitable giving.
  • HR Morning identifies “five ways to help employees who are mental health caregivers.” Aren’t we all mental health caregivers to some extent?

Weekend update

David Ermer–CDC, Congress, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC

  • Congress remains on its State/district work break, with one hearing scheduled to be held in Guam.
  • The Centers for Disease Control reminds us that August is National Immunization Awareness Month by pointing out its immunization guidance website.

From the public health front,

  • Fortune Well discusses skin cancer prevention and identifies “five nutrients that ‘help keep brains in top condition at all ages,’ researchers say.
    •  Lycopene: An antioxidant that could help protect cells from damage, lycopene gives some fruits and vegetables—like tomatoes, watermelon, red oranges, pink grapefruits, apricots, and guavas—their red hue.
    • Retinol: A form of Vitamin A that helps the immune system work properly, retinol helps you see in dim lighting and keeps skin healthy. It’s found in foods like cheese, eggs, oily fish, milk, yogurt, and liver. The body can convert beta-carotene into retinol, so indirect sources include yellow, red, and green leafy vegetables like spinach, carrots, sweet potatoes, and red peppers, as well as yellow fruits like mangos, papaya, and apricots.
    • Lutein: Often referred to as the “eye vitamin,” lutein is thought to protect eye tissue from sun damage. You can find it in foods like egg yolks, spinach, kale, corn, orange peppers, kiwis, grapes, zucchini, and squash.
    • Zeaxanthin: An antioxidant, zeaxanthin is known to protect eye tissues from the sun. It’s found in eggs, oranges, grapes, corn, goji berries, mango, and orange peppers.
    • Vitamin E: Also an antioxidant, Vitamin E keeps free radicals in check, improves immune function, and can prevent clots from forming in the arteries of the heart. It can be found in plant-based oils, nuts, seeds, fruits, and vegetables like sunflower oil, soybean oil, almonds, peanuts, spinach, pumpkin, red bell peppers, asparagus, mangoes, and avocados.
  • CNN reports
    • “As rates of sexually transmitted infections continue to skyrocket across the United States, a growing number of physicians are prescribing a commonly used antibiotic as a way to prevent chlamydia, gonorrhea and syphilis infections in gay and bisexual men and transgender women.
    • “Doxycycline is a class of medications traditionally used to treat bacterial STIs after someone has been infected. Yet recent research suggests that one 200mg dose of the drug can be effective in preventing such infections among men who have sex with men if taken within 72 hours after unprotected sex.
    • “This approach, called doxyPEP, has garnered so much attention that the US Centers for Disease Control and Prevention is expected to post draft guidance for public comment in the next several weeks on how healthcare workers may deploy the preventative treatment, such as how many pills should go into a prescription or which people could benefit most from the drug.”
  • NPR Shots explains how to keep your home’s air clean.
    • Maximize fresh air.
    • Control the source of pollutants.
    • Purify the air.
  • The Wall Street Journal points out seven exercises to improve your hands’ grip.
    • As we age, a firm handshake implies far more than confidence.
    • A strong grip is a great proxy for longevity. Feeble handgrip strength has been shown to be a better predictor of adverse health events like cardiovascular disease and stroke than systolic blood pressure.
    • Your grip involves everything from your forearm muscles to the muscles in your hands, all of which allow us to move our finger joints. A strong grip allows us to hold securely on to things, such as the railing of a staircase, and open stubborn jars of peanut butter or pickles. 

From the U.S. healthcare business front,

  • Fierce Healthcare reports
    • Cigna has launched a new tool that will allow its members to use their smartphones to check for dental health issues, including gum disease and cavities.
    • The insurer announced Thursday morning that the online service, which is backed by Dental.com, will be available for free. It offers guided steps for members to take five photos of their teeth and mouth, which will be analyzed by the SmartScan technology. A Cigna network dentist will then review the scans.
    • The tool will provide members with an oral health score as well as personalized dental care tips. It will also identify any concerns and connect the user with either virtual or in-person follow-ups for treatment.
    • The program is available starting [August 17] to more than 16.5 million Cigna members in employer-sponsored or Affordable Care Act exchange plans, the insurer said.

Cybersecurity Dive

David Ermer–Cybersecurity–

From the cybersecurity policy front —

  • Ars Technica reports
    • The Advanced Research Projects Agency for Health (Arpa-H), a research support agency within the United States Department of Health and Human Services, said today that it is launching an initiative to find and help fund the development of cybersecurity technologies that can specifically improve defenses for digital infrastructure in US health care. Dubbed the Digital Health Security project, also known as Digiheals, the effort will allow researchers and technologists to submit proposals beginning today through September 7 for cybersecurity tools geared specifically to healthcare systems, hospitals and clinics, and health-related devices.
  • FedScoop tells us,
    • Federal agencies got a reminder from the White House yesterday [August 16] of the need to firm up their cybersecurity in compliance with a Biden executive order.
    • The National Security Advisor Jake Sullivan sent a memo to departments and agencies Wednesday morning “to ensure their cyber infrastructure is compliant with” a May 2021 cybersecurity executive order on improving U.S. agencies’ cyber defense, a National Security Council spokesperson said in an emailed statement. 
  • Per NextGov,
    • “The White House is working to develop a 10-year modernization plan for federal civilian agencies as part of a broader effort to transition away from outdated information technology systems while bolstering the nation’s cyber posture, a top official said Tuesday.
    • “Federal Chief Information Security Officer Chris DeRusha told Nextgov/FCW that replacing costly legacy IT systems with resilient and secure technologies has become a top priority for the administration following the release of the National Cybersecurity Strategy earlier this year. 
    • “We need a 10-year modernization plan for legacy IT,” DeRusha said at Nextgov/FCW’sIdentity Security Workshop. “Legacy IT modernization is the number one biggest rock that needs to get moved for us to be able to secure our systems.”
  • NIST released a summary of public comments received on draft Special Publication 800-171 Revision 3, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations. FEHB claims data falls within the scope of this SP.
    • “NIST is adjudicating the comments and preparing the final public draft (fpd) of SP 800-171r3. Concurrently, the team is developing the initial public draft of SP 800-171A, Assessing Security Requirements for Controlled Unclassified Information, which will provide assessment procedures for the SP 800-171r3 security requirements. NIST anticipates releasing SP 800-171r3 fpd and SP 800-171A ipd for public comment in Q1 of FY 2024 (October – December 2023) and looks forward to ongoing engagement with users during the comment period.” 
  • Per Cybersecurity Dive,
    • Cyber authorities are working to mitigate threats to remote monitoring and management tools with assistance from the government and private sector.
    • The defense plan from the Joint Cyber Defense Collaborative “addresses issues facing top-down exploitation of RMM software,” which present a growing risk to small- and medium-sized businesses, the Cybersecurity and Infrastructure Security Agency [CISA] said.

From the cybersecurity vulnerabilities and breaches front,

  • The Health Sector Cybersecurity Coordination Center released a threat analysis of China-based threat actors.
    • “This white paper outlines Chinese cyber threat actors who are known to target the U.S. public health and private health sector entities in cyberspace. The groups outlined within this document represent some of the most capable and deliberate threats to the U.S. healthcare sector, and should be treated with priority when designing and maintaining an appropriate risk posture for a health sector entity.”
  • CISA added one more known exploited vulnerability to its catalog on August 16, 2023.
  • Dark Reading reports
    • “Hackers are on a spree of hijacking LinkedIn accounts, in some cases monetizing the attacks by demanding a small ransom from users to regain access and threatening permanent deletion.
    • “Though LinkedIn, a subsidiary of Microsoft, has not yet commented publicly about the campaign, it has affected people worldwide over the last few weeks. Conversations on social media and Google searches indicate a “significant surge in the past 90 days” of account hacks on the professional-oriented social media platform, according to a recent report published by Cyberint.”
  • Bloomberg Technology examines a larger email hack of Microsoft.
    • “No one likes losing their keys. But after a single Microsoft Corp. key fell into the hands of Chinese hackers, it’s going to take more than changing the locks to restore its reputation. 
    • “The consumer signing key was used to forge authentication tokens — which are meant to verify a user’s identity — and access emails, including the accounts of Commerce Secretary Gina Raimondo and State Department officials, shortly before Secretary of State Antony Blinken traveled to China to meet President Xi Jinping in June.
    • “The world’s largest software maker is now facing increasing criticism from computer security experts and government officials alike over the hack, among the more embarrassing breaches of US government networks since the so-called SolarWinds attack was disclosed in 2020. Russian state-sponsored hackers also abused Microsoft’s software as part of that attack.
    • “Senator Ron Wyden, in a blistering letter last month about the lapse, called for multiple investigations. Shortly after, a US cybersecurity advisory panel opened a probe into the risks of cloud computing, and it is also looking at Microsoft’s role in the email hack.”
  • Health IT Security brings us up to date on the hack that keeps on giving – the MoveIT transfer hack.
    • Entities across the country are still feeling the effects of the MOVEit Transfer hack as more organizations report breaches stemming from the vulnerability.
    • Earlier this week, the Colorado Department of Health Care Policy & Financing (HCPF), which operates Colorado’s Medicaid program, notified more than 4 million individuals of a breach that originated at IBM, which had used the MOVEit software on behalf of HCPF. IBM also notified the Missouri Department of Social Services of the same incident.
    • MOVEit disclosed the vulnerability on May 31 and issued a patch on the same day. 

From the cybersecurity defenses front,

  • Cybersecurity Dive explains why
    • “Security basics aren’t so basic — they’re hard; Lax security controls cause heavy damages, and security experts warn how unmet basics turn up, time and again, when things go wrong” and
  • identifies
    • AWS customers’ most common security mistake; All too often organizations are not doing least-privilege work with identity systems, AWS’ Mark Ryland told Cybersecurity Dive,” and
  • discusses how to take advantage of sometimes disjointed threat intelligence.
  • The Wall Street Journal reports
    • “Hackers exploit the trust relationships between organizations and their third-party suppliers and vendors, resulting in potentially damaging targeted and untargeted attacks.
    • “Understanding the organizations in a supply chain and critical dependencies is essential to reducing the risk, though some threats are nearly impossible to mitigate.
    • “Multiple internal stakeholders working together with technology solutions and consultancy expertise can significantly reduce the risk of, or impact from, supply chain attacks[, e.g., the MoveIT transfer hack].”

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Federal Times says,
    • “Members of Congress are urging the Office of Personnel Management to ensure providers of its health insurance program do not exclude same-sex couples and single individuals from seeking the same artificial reproductive procedures that other federal employees do.”
  • The FEHBlog believes that this expresssed concern misunderstands OPM’s 2024 call letter and technical guidance which focus on fertility coverage and requires carriers to cover artificial insemination, which is typically used by same-sex couples and single individuals.
  • KFF tells us,
  • “A new proposal from the Centers for Medicare & Medicaid Services * * * would authorize Medicare payments to health care professionals to train informal caregivers who manage medications, assist loved ones with activities such as toileting and dressing, and oversee the use of medical equipment. * * *
  • “Several details of CMS’ proposal have yet to be finalized. Notably, CMS has asked for public comments on who should be considered a family caregiver for the purposes of training and how often training should be delivered.
  • “If you’d like to let CMS know what you think about its caregiving training proposal, you can comment on the CMS siteuntil 5 p.m. ET on Sept. 11. The expectation is that Medicare will start paying for caregiver training next year, and caregivers should start asking for it then.”

From the public health front,

  • The Centers for Disease Control announced the availability of flu shots for the 2022-23 flu season and offers flu shot finder tool.
  • Beckers Hospital Review informs us
    • “Health officials have started monitoring BA.2.86 — a highly mutated version of the COVID-19 virus. Not much is known yet about the newly detected lineage, though its large number of mutations has prompted the World Health Organization and CDC to begin tracking the strain. 
    • “The World Health Organization added BA.2.86, dubbed “Pirola” on social media by scientists closely tracking evolutionary changes in the virus, to its list of variants under monitoring Aug. 17. Shortly after, the CDC also said it has started tracking the lineage. 
    • “CDC is gathering more information and will share more about this lineage as we learn it,” the agency said on the social media platform X, formerly known as Twitter. So far, BA.2.86 has been detected in Israel, Denmark, the U.S. and the U.K. So far, only six cases of the new strain have been identified, with the single U.S. case detected in Michigan.” 
  • STAT News discusses the low rates of lung cancer screening in the U.S. notwithstanding the fact that lung cancer is the deadliest cancer in our country.
  • The National Institutes of Health informs us
    • “Past-year use of marijuana and hallucinogens by adults 35 to 50 years old continued a long-term upward trajectory to reach all-time highs in 2022, according to the Monitoring the Future (MTF) panel study, an annual survey of substance use behaviors and attitudes of adults 19 to 60 years old. Among younger adults aged 19 to 30, reports of past-year marijuana and hallucinogen use as well as marijuana and nicotine vaping significantly increased in the past five years, with marijuana use and vaping at their highest historic levels for this age group in 2022. The MTF study is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and is conducted by scientists at the University of Michigan’s Institute for Social Research, Ann Arbor.
    • “While binge drinking has generally declined for the past 10 years among younger adults, adults aged 35 to 50 in 2022 reported the highest prevalence of binge drinking ever recorded for this age group, which also represents a significant past-year, five-year, and 10-year increase.
    • “Substance use is not limited to teens and young adults, and these data help us understand how people use drugs across the lifespan,” said NIDA director, Nora Volkow, M.D. “Understanding these trends is a first step, and it is crucial that research continues to illuminate how substance use and related health impacts may change over time. We want to ensure that people from the earliest to the latest stages in adulthood are equipped with up-to-date knowledge to help inform decisions related to substance use.”

From the medical research front,

  • STAT News relates that “An innovative eye stem cell transplant could help restore vision in people with chemical injuries”
  • Medscape dives into the issue of whether artificial kidneys can replace dialysis.

From the Rx coverage front,

  • The Institute for Clincical and Economic Research reminds us
    • “ICER’s 2022 obesity management Final Evidence Report included subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma). We found that semaglutide used for weight loss would achieve common thresholds for cost-effectiveness if priced between $7,500 – $9,800 per year. The current annual estimated net price is over $13,000.
    • “The Financial Times quoted ICER’s Chief Medical Officer, David Rind, MD:
      • “At current prices, ICER estimated that only 0.1 percent could be treated within five years without ‘major budget disruptions’ for the insurers. ‘The options are to move money away from other healthcare, raise premiums, or taxes if you’re the government, or manufacturers could lower the price to a cost-effective price and still make enormous amounts of money because enormous numbers of patients want this,’ Rind says.” 

From the U.S. healthcare business front

  • Forbes reports,
    • “Blue Shield of California said Thursday it will soon work with several companies to manage the prescriptions of its nearly 5 million health plan members, including Amazon Pharmacy, Cuban’s company and a fast-growing pharmacy benefit manager known as Abarca, which will “pay prescription drug claims.” Financial terms of the arrangement were not disclosed.
    • “But CVS Caremark will continue to provide specialty pharmacy services for Blue Shield “members with complex conditions, including education and high-touch patient support,” the health plan said.
    • “And it’s the specialty pharmacy business that may be a bigger deal to CVS and patients looking for a better deal on their costliest medicines.”
  • Per MedCity News,
    • “Fee-for-services payment models in the primary care ecosystem are doing a poor job of keeping Americans healthy and reducing the nation’s massive amount of healthcare spending, two CEOs of primary care companies said during a recent webinar. They argued that stakeholders in the primary care space need to come together to support more value-based care arrangements to reduce costs, advance population health and improve the patient experience.”
  • Per Healthcare Dive,
    • Rochester, Minnesota-based Mayo Clinic on Thursday reported increased operating revenue and income year over year in its second quarter earnings, driven by higher outpatient visits and surgical cases.
    • The nonprofit posted $4.5 billion in operating revenue, up 10.8% year over year, and $300 million in operating income. Operating expenses rose 7.5% compared to the prior-year period, totaling nearly $4.2 billion, though the cost of salaries and benefits increased at a slower rate this quarter compared with last year.
    • The earnings mark the second consecutive quarter of increased operating margins for Mayo, as the health system attempts to turn around after a rocky 2022 when its operating profit was cut in half.

Thursday Miscellany

David Ermer–Medical / Rx research, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network says,
    • “The largest payroll provider for federal employees is at risk, and if there aren’t improvements soon, hundreds of thousands of employees could see the impacts immediately.
    • “The National Finance Center, an agency housed in the Agriculture Department, is struggling with legacy IT systems, limited funding, low staffing — and even building maintenance issues. In a new nine-month study, the National Academy of Public Administration said NFC must take immediate action or else risk being unable to provide payroll services to more than 170 agency customers, spanning some 650,000 federal employees.
    • “It is unthinkable that the U.S. government could find itself in a position where it could not pay a sizeable portion of the federal workforce — but it could happen, at least in the short term,” the NAPA report, published earlier this month, said.”
  • Ruh-roh.
  • In other puzzling news, Healthcare Dive informs us that a committee advising Congress on how to avoid surprise billing with ground ambulance charges decided against using the No Surprises Act IDR process but does not appear to have a good alternative. The committee meets again in October and plans to submit its report to Congress later this year.

From the U.S. healthcare business front,

  • The Wall Street Journal lets us know,
    • “A major health insurer says it will jettison the complicated system that Americans use to pay for drugs and create something that aims to be better, with partners including Amazon.com and the entrepreneur Mark Cuban.
    • “Blue Shield of California said it is dropping CVS Health’s Caremark, the pharmacy-benefit manager it currently uses, which negotiates drug prices and wraps in other services such as a mail-order pharmacy.
    • “Instead, Blue Shield, a nonprofit health plan with about 4.8 million members, will work with a selection of companies that each perform a designated function. Amazon will offer at-home drug delivery. Cuban said Mark Cuban Cost Plus Drug Company will provide access to low-cost medications, including through retail pharmacies. Another company, Abarca, will process drug claims.
    • “Blue Shield said that working with its partners, it aims to negotiate prices with pharmaceutical makers in a way that is different from the typical approach—with a simple net price structure that is supposed to eliminate rebates and hidden fees. 
    • “Blue Shield executives said that with one company handling many aspects of how drugs are procured through the system, it is often hard to track the flow of payments accurately.”
  • Health Payer Intelligence also discusses this new unbundled PBM arrangement and related developments.
  • The Segal Co. points out,
    • “The average stop-loss coverage premium increase is 8.4 percent for the nearly 250 health plans in Segal’s national medical stop-loss database’s 2023 dataset.
    • “The average includes groups that increased specific stop-loss deductible levels and/or aggregating specific stop-loss deductibles resulting in an overall reduced rate action. The average premium increase for groups that maintained similar specific stop-loss benefit levels as the prior year is 13.4 percent.”
  • Fierce Healthcare notes
    • “Tech company HealthEdge polled more than 2,800 insured people to delve into their attitudes toward their health plan and where they think payers can improve the experience.
    • “The survey asked respondents what they think insurers should be doing to improve satisfaction. Five steps ranked highest:
      • “Offer members incentives and/or rewards for healthy behaviors.
      • “Ensure they can easily access their medical records.
      • “Connect them to providers who offer care based on their preferences and personal traits.
      • “Provide high-quality customer service.
      • “Deploy tools and information that members can use to avoid high-cost care.”
  • From the miscellany department,
  • MedPage Today tells us,
    • “Few people with early Alzheimer’s disease met eligibility criteria for the new anti-amyloid monoclonal antibody treatments lecanemab (Leqembi) and aducanumab (Aduhelm), cross-sectional data from the Mayo Clinic Study of Aging showed.
    • “Of 237 people with mild cognitive impairment or mild dementia and increased brain amyloid on PET, clinical trial inclusion and exclusion criteria narrowed the number who would qualify for a lecanemab trial to 19 or 8% of the cohort, reported Maria Vassilaki, MD, Ph.D., of the Mayo Clinic in Rochester, Minnesota, and co-authors. * * *
    • “Our study results show only a small percentage of people with early Alzheimer’s disease may be eligible to receive treatment, mostly due to chronic health conditions and brain scan abnormalities common in older adults,” Vassilaki said in a statement.”
  • Fierce Healthcare relates,
    • “Kaiser Permanente has launched a multichannel support center to better address the social needs of members and nonmembers.
    • “The Community Support Hub is a self-service online directory of community resources. It also includes a call center for referral assistance. The solution will enable Kaiser to have more touch points with patients and better address the overall health of its communities.
    • “Many people need more than high-quality medical care to stay healthy, which is why we’re continuing to support our members beyond clinical walls to seamlessly connect them to the community resources they need to live healthy, thriving lives,” Bechara Choucair, M.D., senior vice president and chief health officer, said in a press release.
    • “If you’re not a KP member, your friend is, your neighbor is,” Vice President of Social Health Anand Shah, M.D., told Fierce Healthcare. In effect, there is no distinction between a member and a community. “You can’t have one without the other.” 
  • BioPharma Dive reports,
    • A drug combination involving Gilead’s antibody medicine Trodelvy shrank or eliminated tumors in just over half of the lung cancer patients who received it in a closely watched Phase 2 trial, according to data released ahead of a medical meeting next month. The findings suggest Trodelvy, currently approved to treat breast and bladder cancers, may be active against lung tumors as well.
    • The study, EVOKE-02, is testing several regimens of Trodelvy and Merck & Co.’s immunotherapy Keytruda with or without chemotherapy in patients newly diagnosed with advanced non-small cell lung cancer. Full results were inadvertently published Wednesday, weeks before the data will be presented at the World Conference on Lung Cancer.