Weekend update

David Ermer

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

Weekend update

David Ermer–Congress, FDA, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC —

  • While on August recess, Congress is holding four out-of-town hearings.
  • The recently proposed mental health parity rule was published in the Federal Register last Thursday. The deadline for public comments is October 2, 2023.
  • WTOP reports,
    • “President Joe Biden has asked Cabinet officials to “aggressively execute” plans to bring federal employees back to their offices, ending a precedent of remote work that started during the COVID-19 pandemic three years ago, according to multiple sources.
    • “Axios first reported that White House Chief of Staff Jeff Zients sent an email on Friday to every member of the Cabinet saying federal agencies must return to in-person work “because it is critical to the well-being of our teams and will enable us to deliver better results for the American people.”
    • “Zients said remote work won’t be completely eliminated, but that in-person time will be prioritized to “build a strong culture, trust, and interpersonal connections” within agencies, according to The Washington Post.”

From the public health front —

  • Fortune Well provides more background on the new Sage Therapeutics drug that the Food and Drug Administration approved to treat post-partum depression last Friday.
    • “In trials, zuranolone [trade name Zurzuvae] showed a “rapid reduction of depressive symptoms starting as early as day three—after two doses of medicine—and showed continued improvement through day 15,” Deligiannidis said, adding that the drug continues to work even after patients stop taking it, for 45 days in all.
    • “The fast-acting, temporary nature of the drug stands in contrast to standard-of-care antidepressants that might otherwise be prescribed. Such medications—typically SSRIs, or selective serotonin reuptake inhibitors, which increase serotonin levels in the brain—usually take four to six weeks to begin to work, and two to three months to fully kick in, according to Deligiannidis. * * *
    • “Because zuranolone is a controlled substance, the U.S. Drug Enforcement Administration now has 90 days to assign a schedule to it. Earlier this week, Chepke predicted it would be designated a Schedule IV drug or one with a low potential for abuse and dependence like Xanax, Valium, Ativan, and Ambien.
    • “From there, he anticipated it would soon be in the hands of prescribers and patients, where it’s sorely needed. * * *
    • “Sage Therapeutics and co-developer Biogen had also applied for approval to use the drug in cases of major depressive disorder. The federal agency on Friday did not issue a ruling on such use.”
  • NPR Shot tells us “Testing your genes for cancer risk is way cheaper now — and it could save your life.”

From the Rx coverage front —

  • The FEHBlog wants to point out the Center for Biosimilars website, which is chock-a-block full of useful articles on this important topic.
  • BioPharma Dive reports
    • “The Food and Drug Administration on Friday approved a second medicine for a common type of vision loss, clearing a drug developed by biotechnology company Iveric Bio for geographic atrophy.
    • “The monthly eye injection, which will be sold as Izervay, is meant to slow the progression of the condition, which Iveric and its new owner, Japanese drugmaker Astellas Pharma, estimate affects 1.5 million people in the U.S.
    • “The FDA’s decision on Izervay follows about six months after the agency greenlighted the first geographic atrophy treatment, Apellis Pharmaceuticals’ Syfovre. Both drugs work by blocking a part of the immune system, slowing the growth of eye lesions and, in theory, preserving vision. Such a benefit on visual function hasn’t been proven yet, however.
    • “The medicines are expected to become blockbuster sellers.”

From the U.S. healthcare business front —

  • KFF News offers “An Early Look at What is Driving Health Costs in 2024 ACA Markets.”
    • “This updated analysis of marketplace insurers’ early rate filings are requesting a median premium increase of 6% for 2024, which they say is largely due to price increases for medical care and prescription drugs. Insurers’ rate requests are preliminary and may change during the review process before being finalized in late summer.
    • “In addition to inflation’s impact on medical costs, insurers say the higher premiums are a result of growth in the utilization of health care, which fell in 2020 but has since returned to more normal levels.
    • “The analysis is available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.”
  • Although the FEHB is affected by the same cost drivers, OPM’s wise decision to approve the use of Part D EGWPs in the FEHB for 2024 will offset these cost drivers to a substantial extent.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front —

  • Cybersecurity Scoop reports,
    • “The Cybersecurity and Infrastructure Security Agency [CISA] released its strategic plan for fiscal year 2024 through 2026 on Friday, following a plethora of strategies and implementation plans released over the past several months by the White House aimed at improving the nation’s overall cybersecurity preparedness. 
    • “Within CISA, this Plan will serve as a keystone for implementation, resource, and operational planning, as further executed through our Annual Operating Plans. Externally, it will help stakeholders understand and participate in our long-term cybersecurity planning and prioritization,” the document reads.
    • “CISA’s strategic plan will focus on three goals: address immediate threats, harden the terrain and drive security at scale. Additionally, the strategy has nine objectives, three for each goal, outlining the agency’s scope for the next three years.
    • “The release comes shortly after the Office of the National Cyber Director released a National Cyber Workforce and Education Strategy, as well as the National Cybersecurity Strategy in March and subsequent Implementation Plan in July.”
  • and
    • “The Biden administration’s strategy for building the U.S. cybersecurity workforce calls for government, industry and civil society groups to collaborate in increasing the number of cybersecurity workers and also urges an overhaul of the U.S. immigration system. 
    • “To address a dire shortage of cybersecurity workers, Monday’s strategy document takes a broad approach in overhauling the cybersecurity workforce. “The national cyber director’s office can only really task federal departments and agencies because, realistically, we need all of society. We need them to be feel supported and heard and seen as we approach these ecosystem models,” Acting National Cyber Director Kemba Walden told CyberScoop.”

From the cybersecurity breaches and vulnerabilities front —

  • Health IT Security brings us up to date on MOVEit breaches affecting healthcare organizations.
  • Health IT Security adds, “The healthcare sector continued to face a high volume of cyberattacks in the past few months as infostealing malware rose in popularity, BlackBerry stated in its latest Global Threat Intelligence Report.”
  • Cybersecurity Dive reports
    • “Half of the 12 most-commonly exploited vulnerabilities in 2022 were discovered the previous year, cyber authorities from the Five Eyes said in a joint advisory released Thursday. One of the top 12 vulnerabilities was discovered in 2018.
    • “Flaws in Microsoft products accounted for 1 in 3 of the most-routinely exploited vulnerabilities, including three Exchange Server CVEs from 2021. Two-thirds of the most-exploited vulnerabilities were found in products from three vendors: Atlassian, Microsoft and VMware.
    • “Other vendors that made the list include Apache’s Log4j, F5 Networks, Fortinet and Zoho.
    • * * * “Delayed or inconsistent vulnerability patching remains an underlying problem. This, combined with the unmet need for vendors, designers and developers to adhere to secure-by-design and secure-by-default principles, is aggravating the risk of compromise by malicious cyber actors.
    • “The Five Eyes intelligence alliance, which includes authorities from the U.S., Australia, Canada, New Zealand and the U.K., reiterated the need for vendors to follow secure design practices throughout the software development lifecycle.”
  • Security Week tells us
    • The US government’s cybersecurity agency CISA is calling attention to under-researched attack surfaces in UEFI [Unified Extensible Firmware Interface], warning that the dominant firmware standard presents a juicy target for malicious hackers.
    • “UEFI is a critical attack surface. Attackers have a clear value proposition for targeting UEFI software,” the agency said in a call-to-action penned by CISA technical advisor Jonathan Spring and vulnerability management director Sandra Radesky. 
  • CISA’s Director Jen Easterly blogs about the importance of securing the Border Gateway Protocol, which she describes as being the most important part of the internet you have never heard of.
  • On July 31, CISA added another known exploited vulnerability to its catalog.

From the ransomware front —

  • HHS’s Health Sector Cybersecurity Coordination Center released a sector alert on August 4, 2023.
    • “Rhysida is a new ransomware-as-a-service (RaaS) group that has emerged since May 2023. The group drops an eponymous ransomware via phishing attacks and Cobalt Strike to breach targets’ networks and deploy their payloads. The group threatens to publicly distribute the exfiltrated data if the ransom is not paid. Rhysida is still in early stages of development, as indicated by the lack of advanced features and the program name Rhysida-0.1. The ransomware also leaves PDF notes on the affected folders, instructing the victims to contact the group via their portal and pay in Bitcoin. Its victims are distributed throughout several countries across Western Europe, North and South America, and Australia. They primarily attack education, government, manufacturing, and technology and managed service provider sectors; however, there have been recent attacks against the Healthcare and Public Health (HPH) sector.”
  • Bleeping Computer informs us that “Clop ransomware now uses torrents to leak data and evade takedowns” and it offers its Week in Ransomware.
    • “Ransomware gangs continue to prioritize targeting VMware ESXi servers, with almost every active ransomware gang creating custom Linux encryptors for this purpose.
    • “This week, BleepingComputer analyzed the Linux encryptor for Abyss Locker and illustrated how it was specifically designed to encrypt ESXi virtual machines.”

From the cybersecurity defenses front —

  • Per Forbes
    • “Traditional passwords have proven to be an increasingly problematic authentication strategy in the evolving face of cybersecurity. Biometrics, such as fingerprints, facial recognition and iris scanning, are ushering in a new era of safe authentication.
    • “Biometrics provide distinct advantages over passwords in terms of security, convenience and user experience. But why exactly are biometrics more secure, and how can businesses successfully implement this technology into their existing strategies?
    • Forbes article explains how.
  • HelpNet offers advice on building cybersecurity defenses.
  • Security Intelligence explains how artificial intelligence can reduce data breach life cycles and costs.

Friday Factoids

David Ermer–COVID-19, FDA, HSA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The Food and Drug Administration announced today
    • “approv[ing Sage Therapeutic’s] Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a healthcare provider in certain healthcare facilities.
  • STAT News informs us
    • “A new White House task force on drug shortages held a rare in-person meeting last Friday with representatives from hospitals, drugmakers, pharmacies, and others in the drug supply chain to brainstorm policies for stemming shortages of cancer drugs.
    • “The meeting at the Eisenhower Executive Office Building focused on immediate steps that could help alleviate shortages, such as allowing temporary importation of drugs from other countries, according to an attendee and three others with knowledge of the discussion. It also touched on purchasing issues.”
  • HR Dive relates
    • “The National Labor Relations Board on Wednesday reversed its Trump-era stance that allowed employers to maintain certain handbook policies, such as those mandating a respectful workplace (Stericycle, Inc. and Teamsters Local 628).
    • “The shift means all policies that restrict employee speech and actions must be reviewed — “and very likely rewritten,” according to Peter Spanos, a partner at law firm Taylor English.”

From the public health front —

  • The Leapfrog Group now offers ratings on maternity care services.
  • Health Day relates,
    • “A micronutrient in human breast milk may provide significant benefit to developing newborn brains, according to new research that sheds light on the link between nutrition and brain health.
    • “Scientists looked at this sugar molecule in rodents and in human neurons. They said the micronutrient, called myo-inositol, may lead to improved infant formulas.
    • “The current research does indicate that for circumstances where breastfeeding is not possible, it may be beneficial to increase the levels of myo-inositol in infant formula,” said study co-author Thomas Biederer.
    • “Myo-inositol may also play a part in the aging brain, according to the research conducted at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) at Tufts University in Boston.”
  • STAT News lets us know,
    • “Early-stage cancer diagnoses decreased by nearly 20% in the first year of the Covid-19 pandemic. A new study published in Lancet Oncology emphasizes how, because of disruptions in care, patients were more likely to get diagnosed with deadly metastatic disease — across nearly all cancer types.
    • “This study is the most comprehensive analysis of cancer diagnoses during the pandemic, using a nationwide registry that captures over 70% of all cancers in the United States. The starkest decline was observed after the initial shutdowns, with the regular 70,000 monthly cancer diagnoses (captured by the study’s inclusion criteria) being cut in half in April 2020.”
  • KFF News offers polling data on consumer interest in the new injectable weight loss drugs and their attitudes toward pharmaceutical companies and “A Look at the Latest Suicide Data and Change Over the Last Decade” in our country.

From the U.S. healthcare business front —

  • The Kaiser Foundation announced
    • “For the quarter ending June 30, 2023, Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their respective subsidiaries (KFHP/H) reported operating revenues of $25.2 billion and operating expenses of $24.4 billion compared to operating revenues of $23.5 billion and operating expenses of $23.4 billion in the same period of the prior year. Operating income was $741 million for the second quarter of the year compared to operating income of $89 million in the second quarter of 2022.
    • “Like all health systems, Kaiser Permanente is experiencing ongoing cost headwinds and volatility driven by inflation, labor shortages, and the lingering effects of the pandemic on access to care and service.
    • “Due to favorable financial market conditions, Kaiser Permanente benefited from strong investment income with other income (net of other expenses) of $1.3 billion for the second quarter, compared to a $1.4 billion loss in the second quarter of 2022. For the second quarter, net income was $2.1 billion compared to a net loss of $1.3 billion in the same period of 2022.”
  • Healthcare Dive points out
    • “Patrick Conway is stepping up as CEO of UnitedHealth pharmacy benefit manager OptumRx effective immediately, according to a Thursday post on the executive’s LinkedIn, as part of a leadership shakeup at the healthcare giant.
    • “Conway is replacing Heather Cianfrocco, who is pivoting to president of Optum. Cianfrocco will lead the division’s pharmacy and care delivery capabilities, per UnitedHealth’s website.
    • “Cianfrocco replaces John Prince as Optum president. Prince has departed the company to serve as a senior advisor to private equity firm TPG, according to his LinkedIn.”
  • EBRI announced
    • “A new research report published today by the Employee Benefit Research Institute (EBRI) found that cost-sharing shifted from deductibles to copayments and coinsurance among enrollees in HSA-eligible health plans for a number of services impacted by IRS Notice 2019-45. The report, “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Employee Choice of Health Plan and Cost Sharing,” analyzed claims data to quantify the effect of expanding pre-deductible coverage on enrollee choice of health plan and cost-sharing.
    • “In response to IRS Notice 2019-45, three-quarters of large employers and health plans offering HSA-eligible health plans expanded pre-deductible coverage for medications and services that prevent the exacerbation of chronic conditions. As a result, it is not surprising that when examining medical claims, cost-sharing shifted from deductibles to copayments and coinsurance for enrollees in HSA-eligible health plans,” explained Paul Fronstin, Ph.D., director, Health Benefits Research, EBRI. “The percentage of cost sharing paid through deductibles fell for antidepressants, insulin and other glucose-lowering agents, statins, beta blockers and inhaled corticosteroids.”
  • Health Payer Intelligence updates us on the status of provider challenges to the No Surprises Act’s arbitration rules.
    • “The legal challenges highlight the difficulties of prioritizing affordable healthcare for consumers. With payers and providers holding opposing views, federal policymakers must reach a conclusion that benefits both sides and improves costs for consumers.
    • “If federal agencies cannot establish reasonable guidelines for the IDR process, Americans may face an inflationary federal IDR process that results in higher premiums and healthcare costs, according to Georgetown University’s O’Neill Institute.
    • “There is a strong urgency to determine concrete guidelines, given the high amount of disputes that payers and providers have submitted through September 2022, a CMS report indicated.”
  • Behavioral Health Business reports
    • “The Cigna Group (NYSE: CI) has seen a historic but expected rise in behavioral health benefits utilization in recent years. 
    • “These insights, presented by the health care insurance and service conglomerate’s executives, echo others made by UnitedHealth Group (NYSE: UNH) executives on their second-quarter earnings call. 
    • “As it relates to what we’re seeing in terms of trends in terms of utilization, behavioral health has certainly been growing at a strong clip, not just this year, but for the past few years,” Brian Evanko, The Cigna Group’s CFO said Thursday on the company’s second-quarter earnings call. “Part of that is by design as we engage with our customers. And over time, that’s a good thing because the more utilization we see in behavioral health services, [the more] it helps to defray core medical costs.”

Thursday Miscellany

David Ermer–ACA, AHRQ, CDC, COVID-19, FDA, Telehealth, U.S. Healthcare–

From Washington, DC —

  • Medscape tells us
    • “The US Food and Drug Administration (FDA) [on July 31] cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.
    • “The device helps identify lesions in real time, and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.”
  • MedPage Today lets us know,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously — 10 to 0 — in favor of nirsevimab (Beyfortus) for protecting a wide swath of at-risk infants from respiratory syncytial virus (RSV).
    • “At a meeting on Thursday, ACIP recommended that all infants younger than 8 months who are born during or approaching their first RSV season receive one dose of nirsevimab.
    • “The advisory committee also voted 10-0 to recommend that children 8 to 19 months who are at increased risk of severe RSV and approaching their second RSV season receive one dose of the monoclonal antibody against RSV.
    • As a result of this action, FEHB plans and health plans generally must cover the preventive service with no cost sharing when delivered in-network.
  • The Labor Departments Office of Federal Contract Compliance Programs announced
    • “a final rule titled “Pre-enforcement Notice and Conciliation Procedures.”
    • “The final rule modifies the agency’s earlier rule, “Nondiscrimination Obligations of Federal Contractors and Subcontractors: Procedures to Resolve Potential Employment Discrimination” which took effect on December 10, 2020. * * *
    • “To learn more, read Acting Director Michele Hodge’s blog about the final rule here. You can also read the Final Rule here.  
    • “The final rule will take effect on September 5, 2023.”

From the public health front —

  • UPI reports, “In examining real-world data on the long-term health of elderly patients who received the COVID-19 vaccine, researchers at Brown University and Boston-based Hebrew SeniorLife determined that the Moderna variety was the safest and most effective for older adults.”
  • The Washington University School of Medicine announced,
    • “Scientists at Washington University in St. Louis have developed a breath test that quickly identifies those who are infected with the virus that causes COVID-19. The device requires only one or two breaths and provides results in less than a minute.
    • “The study is available online in the journal ACS Sensors. The same group of researchers recently published a paper in the journal Nature Communications about an air monitor they had built to detect airborne SARS-CoV-2 — the virus that causes COVID-19 — within about five minutes in hospitals, schools and other public places.”
  • MedPage Today informs us
    • “Thymectomy carried a substantially increased risk of all-cause mortality and cancer for adults, a “landmark” study showed.
    • “Adults who had undergone thymectomy had at least double the risk of all-cause mortality and cancer at 5 years post-surgery compared with matched patients who had undergone cardiothoracic surgery without thymectomy * * *.
    • “Incidental thymectomy is common during cardiothoracic surgery due to the pyramid-shaped organ’s location in the chest in front of the heart where surgeons need to access the surgical field.
    • “While the thymus plays a critical role in normal immune system development, it was thought to be safe to remove in adulthood, “particularly since the thymus naturally involutes with age,” the researchers noted.
    • “Their conclusion from the study was that the thymus continues to be functionally important for human health in adulthood.”
  • HHS’s Agency for Healthcare Research and Quality has made available a
    • “Toolkit for Improving Perinatal Safety, a second bundle of AHRQ tools is available to improve the safety culture of labor and delivery (L&D) units. The second bundle provides resources that align the toolkit’s adaptive care processes with the clinical care processes recommended in the Alliance for Innovation on Maternal Health (AIM) program.
    • “The new tools are designed to help L&D units reduce obstetric hemorrhage and severe hypertension in pregnancy, two leading known causes of preventable maternal mortality and severe maternal morbidity in the United States.”
  • On a related note, Fierce Healthcare reports
    • “To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.”To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.
    • “HCSC said it wants to increase access to providers and reduce gaps in healthcare as well as engage and educate residents about maternal and infant well-being. The customer-owned health insurer plans to install the program in the states in which it operates: Illinois, Montana, New Mexico, Oklahoma and Texas.
    • “The initiative will first launch in the Lone Star State, HCSC said.
    • “We’re collaborating with trusted community organizations and partners, leveraging their knowledge, experience and talents on a local level,” HCSC Chief Clinical Officer Monica Berner, M.D., said in a press release. “We seek to build healthier communities by using our resources to respond to societal needs.”
  • KFF News points out that “Doctors Sound Alarm About Child Nicotine Poisoning as Vapes Flood the US Market.”

From the U.S. healthcare business front —

  • Beckers Payers Issues notes
    • “The Cigna Group raised its year-end revenue projections to $190 billion and reported a 6 percent decrease in shareholders’ net income, according to the company’s second quarter earnings published Aug. 3.
    • “Total revenues in the second quarter were $48.6 billion, up 7 percent year over year.
    • “In the second quarter, net income was nearly $1.5 billion, down 6 percent from $1.6 billion year over year. The company cited an absence of income from recently divested businesses, including the sale of businesses to Chubb in six countries and divestiture from a joint venture in Turkey.
    • “Evernorth pharmacy revenues rose 7 percent year over year to $35.2 billion. The insurance side of the business, Cigna Healthcare, reported second-quarter revenues of $12.7 billion, up 11 percent from the previous year.
    • “The company’s medical loss ratio was 81.2 percent in the second quarter, compared to 80.7 percent during the same period last year.”
  • Healthcare Dive adds
    • “Investors were concerned about medical cost trends coming into the second quarter, but health insurers have largely bucked the worst of rising expenses. Cigna, one of the last major payers to report earnings, was no different.
    • “We planned and priced for more normalized levels of utilization this year. Our year-to-date claims experience has been broadly in line with this expectation,” Cigna CFO Brian Evanko said in a Thursday morning call with investors.”
    • Cigna’s medical loss ratio, or how much of the premium dollar is spent on patient care, was 81.2% in the second quarter, according to new financial results — better than analysts expected.
  • Healthcare Dive also reports
    • “Telehealth company Amwell lowered its 2023 revenue outlook after missing analyst expectations and racking up another non-cash goodwill impairment charge in the second quarter.
    • “The company now expects to bring in revenue between $257 million and $263 million for the year, compared with earlier guidance of $275 million to $285 million, Amwell said in second-quarter results released Wednesday. 
    • “Amwell’s revenue declined 3% year over year to $62.4 million in the quarter. The telehealth vendor posted a net loss of $93.5 million, which included a $27.3 million goodwill impairment charge to make up for the “sustained decrease” in Amwell’s stock and market capitalization, according to an SEC filing.”
  • Fierce Healthcare lets us know
    • “UnitedHealthcare tapped 66 not-for-profit organizations spread over 12 states to receive grant funding to help expand access to care.
    • “The $11.1 million in grant funding, which falls under UnitedHealthcare’s Empowering Health program, aims to help improve the healthcare options of individuals living in underserved communities by addressing the social determinants of health, the insurance giant said. Specifically, it’ll target food insecurity, social isolation, behavioral health issues and health literacy efforts.
    • “Some of the organizations to receive funds include the Upstate Foundation in Syracuse, New York, CHRIS 180 in Atlanta and Trellis in Minneapolis and Saint Paul.”

Midweek Update

David Ermer–ACA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC —

  • MedPage Today informs us
    • “In a letter to the American public, the heads of the Drug Enforcement Administration (DEA) and FDA acknowledged ongoing stimulant drug shortages [to treat ADHD] and recounted their initiatives to improve access — while calling for efforts to diminish potential overuse and misuse of these powerful medications.”
  • and
    • “Jeanne Marrazzo, MD, will be the next director of the National Institute of Allergy and Infectious Diseases (NIAID), NIH Acting Director Lawrence Tabak, DDS, PhD, announced on Wednesday.
    • “Dr. Marrazzo brings a wealth of leadership experience from leading international clinical trials and translational research, managing a complex organizational budget that includes research funding and mentoring trainees in all stages of professional development,” Tabak said in a press release. “I look forward to welcoming Dr. Marrazzo to the NIH leadership team.”
  • FedWeek explains why the federal long-term care insurance program is the “Zeppo Marx” of federal employee benefits programs and offers information about deferred annuities available to federal employees.
    • Conundrum “If you are eligible for a deferred annuity, you may elect a survivor annuity. However, you won’t be eligible either to participate in the Federal Employees Health Benefits program or acquire Federal Employees’ Life Insurance coverage.”

From the public health front —

  • From Healthcare Dive, we have an opinion piece titled, “Strengthening primary care the key to fixing healthcare system woes. Primary care advocates Ann Greiner and Shawn Martin argue the U.S. needs to turn around decades of underinvestment in its primary care chassis.” Check it out.
  • The Wall Street Journal reports that some large employer-sponsored health plans, such as the University of Texas, are canceling coverage of GLP-1 agonistes, like Wegovy, for weight loss treatment due to the high cost of the drugs. The UT plan will continue to cover these drugs, like Ozempic, for diabetes treatment.
    • “The prescription-drug benefit plan for state government employees in Connecticut now requires members to obtain anti-obesity drugs through Intellihealth, a Connecticut-based, anti-obesity medical practice that offers telehealth and app-based care.  
    • “The state’s costs for the GLP-1 anti-obesity drugs for plan members have risen 50% since 2020, and are on track for $30 million annually by the end of this year, said Connecticut State Comptroller Sean Scanlon.
    • “To me, saying we’re not going to cover these anymore was a nonstarter, because these drugs do work. People want to take them,” he said.”
  • The University of Michigan’s employee health benefits program raised the deductible on Wegovy from $20 to $45.
    • “Denmark-based Novo Nordisk charges a list price of $1,349 for roughly a month’s supply of each Wegovy and Saxenda. A related drug, Ozempic, is approved to treat Type 2 diabetes and costs about $930 a month, but isn’t typically covered by insurance plans for weight loss in people without diabetes.” That price differential doesn’t make sense to the FEHBlog.
  • MedPage Today tells us
    • “An investigational vaccine that contains the nucleoprotein of the influenza A virus appeared promising as a universal flu shot that could protect against multiple strains, regardless of annual mutations, a phase IIa dose-finding study showed.”
  • CNN informs us
    • “Artificial intelligence found more breast cancers than doctors with years of training and experience and cut doctors’ mammogram reading workload almost in half, a new early-stage study found.
    • “This doesn’t mean your hospital will let a computer determine whether you have cancer any time soon. There’s still a lot more research to do, but the study, published Tuesday in the journal The Lancet Oncology, shows that AI is safe to use in breast cancer detection and could make doctors even more effective at finding cancer than they are now.”

From the U.S. healthcare front

  • Healthcare Dive reports
    • “CVS Health announced a company-wide restructuring initiative on Wednesday after the healthcare giant’s profit fell 37% year over year to $1.9 billion in the second quarter.
    • “As part of the restructuring, the Woonsocket, Rhode Island-based company plans to terminate certain initiatives. That should allow it to reallocate resources to growth areas like healthcare services and technology, CEO Karen Lynch said on a Wednesday call with investors.
    • “CVS lowered its 2024 adjusted earnings per share target from $9 to between $8.50 and $8.70 as a result of cost pressures — flat from its 2023 guidance range. CFO Shawn Guertin also told investors to “no longer rely” on the company’s target of $10 for 2025.”
  • and
    • “Humana beat Wall Street expectations on earnings and revenue in the second quarter, reporting a topline of $26.7 billion, up 13% year over year, and profit of $959 million, up 38% year over year.
    • “Rising medical utilization earlier in the quarter appears to have stabilized based on recent claims activity, management said. The payer on Wednesday reiterated the 2023 medical loss ratio guidance of between 86.3% and 87.3%.
    • “Humana also raised its Medicare Advantage membership growth expectations following the quarter. The Louisville, Kentucky-based health insurer now expects to add 825,000 MA members in 2023.”
  • Fierce Healthcare relates
    • “Amazon Clinic is expanding to all 50 states, including nationwide telehealth services to offer access to clinicians through its website and mobile app.
    • “The online retail giant unveiled Amazon Clinic back in November as a virtual medical clinic to provide care for 35 common health concerns like urinary tract infection, pink eye, and acid reflux. Launched as a message-based virtual consultation service, Amazon Clinic connects consumers with licensed clinicians who can diagnose, treat and prescribe medication for a range of common health and lifestyle conditions.
    • “The service was available in 34 states and has now been expanded nationwide and to Washington, D.C., along with the addition of video visits with providers on Amazon.com and the mobile app, the company announced in a blog post on Tuesday.
    • “Amazon Clinic is currently cash pay and does not yet accept insurance, the company said.” 
  • Beckers Payer Issues points out
    • “The first wave of UnitedHealthcare’s previously announced 20 percent reduction in prior authorization requirements takes effect Sept 1. 
    • “The remainder of the reductions will occur Nov. 1, according to an Aug. 1 post on UnitedHealthcare’s website. 
    • “The prior authorization code eliminations will take place on Sept. 1 and Nov. 1 for Medicare Advantage, commercial, Oxford, and individual exchange plans. Eliminations for community plans will take place Nov. 1. “
  • and
    • “UnitedHealthcare controls almost one-quarter of the Medicare Part D plan market, according to an analysis from KFF.
    • “The analysis, published July 26, compared market share in 2023 for major payers offering both Medicare Advantage plans and stand-alone Part D plans.
    • “Most payers analyzed, aside from Kaiser Permanente, offer both standalone plans and Medicare Advantage policies, according to KFF. CVS Health, Centene and Cigna have greater enrollment in standalone Part D plans than Medicare Advantage options, while UnitedHealthcare and Humana have more Medicare Advantage members.”
  • Benefits Pro reassures us
    • “When the Affordable Care Act was passed in 2010, it was assumed that many employers would drop workplace health insurance in response. However, a new study by the Employee Benefit Research Institute found that starting in 2015, both the percentage of employers offering health insurance and the percentage of workers eligible for such coverage began to increase.
    • “It should then come as no surprise that the percentage of workers and their families being covered by employment-based health insurance has been relatively steady over the long term,” the report said.”

Tuesday’s Tidbits

David Ermer–ACA, Medicare, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • STAT News reports
    • “The U.S. Department of Labor claims in a new lawsuit that a UnitedHealth Group unit illegally rejected emergency room care and urine drug screen claims for thousands of people.
    • “UMR, Inc., a Wisconsin-based third-party administrator owned by UnitedHealth, manages benefits for more than 2,100 employee health plans. The federal government says the company denied ER visits and urine drug screens for years using a process that didn’t meet federal standards for health plans that employers fund themselves, known as self-insured plans. The standards are part of a law called the Employee Retirement Income Security Act, or ERISA.
  • The FEHBlog is concerned that the focus of the lawsuit is on services that are well known to be overutilized. Moreover, like the Cigna case, the lawsuit is an attack on auto-adjudication, which the government encouraged.
  • The U.S. Preventive Services Task Force reaffirmed a Grade A recommendation that all persons planning to or who could become pregnant take a daily supplement containing 0.4 to 0.8 mg (400 to 800 mcg) of folic acid at least 1 month prior to anticipated conception and continue through the first 2 to 3 months of pregnancy.

From the Medicare front —

  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) has locked in a 3.1% pay bump for inpatient payments to eligible hospitals during fiscal year 2024, which the agency said translates to a $2.2 billion increase in hospital payments.
    • “The baseline inpatient pay rate the agency listed Tuesday afternoon in the FY 2024 Inpatient Prospective Payment Systems (IPPS) and Long-term Care Hospital Prospective Payment System (LTCH PPS) final rule is higher than the 2.8% proposed back in April. However, the listed payout $2.2 billion payout increase is well below the $3.3 billion boost CMS had said in the proposed rule’s fact sheet that hospitals would receive starting this October.
    • “The final rule’s inpatient payment rate reflects a projected FY 2024 IPPS hospital market basket update of 3.3%, reduced by a statutory 0.2 percentage point productivity adjustment intended to reflect longitudinal gains in care delivery efficiency. This applies to general acute hospitals that participate in the IPPS Quality Reporting Program and meaningfully use electronic records.”
  • Health Payer Intelligence points out,
    • “Medicare Part D premiums are projected to decrease from $56.49 in 2023 to $55.50 in 2024, CMS announced.
    • “The projected average Part D premium represents the sum of the average basic premium and the average supplemental premium for plans with enhanced coverage.
    • “The breakdown of the 2024 premium consists of a $34.50 basic Part D premium and a $21.00 supplemental Part D premium.
    • “The agency expects the total Part D premium to fall by 1.8 percent next year, partly due to premium stabilization.
    • Starting in 2024, the Inflation Reduction Act limits the growth in the base beneficiary premium to a 6 percent annual increase. The base beneficiary premium is the basis for calculating a plan-specific Part D premium. This premium will increase by 6 percent in 2024 to $34.70. Without the Inflation Reduction Act provision, the cost would have been $4.65 higher at $39.35.”

In other U.S. healthcare news

  • U.S. News and World Report issued its 2023 U.S. hospital rankings today.
  • Fierce Healthcare relates
    • “Nationwide hospital margins continued their upward recovery in June, though analysts warn that not all hospitals are seeing their fortunes improve.
    • “Per data from consulting firm Kaufman Hall’s latest monthly report, hospitals’ median year-to-date operating margin index rose to 1.4% while the single-month operating margin index hit 3.8%.
    • “Still, “most hospitals underperformed slightly compared to May” due to persistent high expenses and other economic pressures, the firm said. The overall margin improvement could also have benefited from fiscal year-end accounting adjustments, the group wrote in its report, while underlying data suggest that many facilities are finding their finances far from the mean.
    • “As margins continue to stabilize on the surface, the gap between high-performing hospitals and those struggling in this new financial environment is widening,” Kaufman Hall said in an accompanying release.”
  • The Wall Street Journal reports
    • Pfizer reported second-quarter revenue Tuesday that fell short of analysts’ estimates as record sales from its Covid-19 products dry up. 
    • Pfizer says its strategy of relying on internal innovation is bearing fruit, with a series of new drug approvals coming in the second quarter and drugs from recent deals helping drive revenue. 
  • Beckers Payer Issues explains
    • Around 6 in 10 health plans have provider education in place to promote alternative options to costly GLP-1 drugs like Ozempic and Wegovy for obesity and diabetes treatment, according to a survey from diabetes management provider Vitra Health. 
    • In a survey of 80 health plan leaders published Aug. 1, all of the leaders responded they were concerned about the rising costs and utilization of GLP-1 drugs.  * * *
    • See the full survey here. 

Monday Roundup

David Ermer–CMS, FDA, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • The American Hospital Association reports
    • “The Centers for Medicare & Medicaid Services released its fiscal year 2024 final rule for the skilled nursing facility prospective payment system. The rule will increase payments by a net 4.0%, or $1.4 billion, in FY 2024 relative to FY 2023 levels. This includes a 3.0% market basket increase which was reduced by a 0.2% productivity cut, increased by a 3.6% market basket forecast error adjustment for FY 2022, and reduced by a 2.3% behavioral adjustment related to the transition to the patient-driven payment model.”
  • and
    • “The Centers for Medicare & Medicaid Services today announced the Guiding an Improved Dementia Experience (GUIDE) Model, a voluntary national Medicare payment model beginning next July that aims to help dementia patients remain at home and improve the quality of life for them and their caregivers. Participating Medicare Part B providers and suppliers will receive a monthly per-beneficiary amount for providing care management and coordination and caregiver education and support services. Certain safety net providers in the new program track will be eligible for a one-time, lump-sum infrastructure payment to support program development activities. CMS is accepting letters of interest through Sept. 15 and plans to release a request for applications this fall.” 
  • HHS issued “a statement applauding the formation of the Office of Long COVID Research and Practice to lead the Long COVID response and coordination across the federal government and, in addition, the National Institutes of Health (NIH) launch of the Long COVID clinical trials through the RECOVER Initiative.”
  • STAT News reports
    • The U.S. Preventive Services Task Force will discuss recommending Covid-19 screening, the first step in requiring insurers to permanently cover the tests at no cost to patients.
    • The national panel of experts will convene and “determine whether and how Covid-19 screening might be considered within the Task Force’s scope,” chair Michael Barry wrote in a letter to Sen. Elizabeth Warren (D-Mass.) exclusively shared with STAT.
    • Conundrum: “However, he reminded them that “our recommendations only apply to people who do not have any signs or symptoms of disease. We are exploring how testing for Covid-19 might fit within the parameters like these that govern the Task Force’s work.”

From the research front —

  • Cardiovascular Business informs us
    • “Researchers at Harvard University have found that a new hydrogel ink, infused with gelatin fibers, makes it possible to 3D print a functional heart ventricle that beats like a human heart. The group shared its findings in Nature Materials, noting that the same technique can be used to 3D print heart valves, dual-chambered hearts and more.[1]
    • “People have been trying to replicate organ structures and functions to test drug safety and efficacy as a way of predicting what might happen in the clinical setting,” first author Suji Choi, PhD, a research associate with the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), said in a prepared statement. 
    • “Creating these complex structures with 3D printing alone has never been possible, Choi et al. explained—until now.”
  • STAT New points out
    • “Unlike today’s crowded market of SSRIs, prescribed once and taken for months, years, or even indefinitely, zuranolone, developed by Sage Therapeutics, promises something different.
    • “It’s a rapid-acting drug, designed to kick in within the first three days of treatment. The patient takes the medication for 14 days, and then stops. Re-dosing occurs on an as-needed basis.
    • “The Food and Drug Administration is expected to decide whether to approve zuranolone for major depressive disorder and for postpartum depression by Aug. 5. And while Meier had a favorable experience with the drug, it has a checkered clinical trial history: a positive outcome, followed by a negative outcome, followed by another positive outcome.
    • “If approved, zuranolone could give psychiatrists something they’ve been looking for: Drugs that provide relief for their patients more quickly. Zuranolone’s mechanism of action, different than that of other antidepressants, also adds a new type of tool — “pliers,” perhaps — to a toolbox that’s full up on “screwdrivers” and “hammers” already, said Olusola Ajilore, a professor of psychiatry at the University of Illinois Center for Depression and Resilience.”
  • The Wall Street Journal reports
    • “Ultrasound, the decades-old technology known for giving early glimpses of unborn babies, could hold a key to a problem that has long challenged drug developers: getting medicines to hard-to-reach places to treat diseases like Alzheimer’s and cancer.
    • “A cutting-edge approach that combines ultrasound waves with tiny bubbles of inert gas injected into the bloodstream can get more chemotherapy to tumor cells and enable drugs to breach one of the most stubborn frontiers in the human body—the blood-brain barrier. It is also being explored as a new way to deliver gene therapy.
    • “There’s an extremely wide variety of where this sort of drug delivery or augmentation with ultrasound and bubbles can take us,” says Flemming Forsberg, professor of radiology and director of ultrasound physics at Thomas Jefferson University in Philadelphia. The effectiveness of drugs in treating diseases like cancer, Alzheimer’s and Parkinson’s is often limited by poor penetration into tissues, he says, whether in the brain or in tumors in other parts of the body.”

From the U.S. healthcare business front —

  • Tenet Healthcare announced its second quarter 2023 financial results today. Per Becker’s ASC Review,
    • “Tenet Healthcare’s second quarter net income hit $123 million, according to its financial report published July 31. 
    • “Here are four more ASC takeaways:
      • “1. Tenet’s $123 million net income in the second quarter of 2023 is an increase of $85 million over the company’s net income in the second quarter of 2022. 
      • “2. Net operating revenues for the company’s ambulatory care segment was $942 million in the second quarter of 2023. 
      • “3. The $942 million number marks a 22.2 percent increase compared to the second quarter 2022 figure — driven by surgical case growth, acquisition and opening of new facilities, service line growth and improved price yielding. 
      • “4. Same-facility systemwide surgical cases were up 6.6 percent in the quarter and 7.2 percent since the start of 2023.” 
  • Fierce Healthcare tells us
    • “Last year, Blues plan giant Anthem unveiled a corporate rebrand as Elevance Health, a move it said better illustrated its ambitions to be more than just a health plan.
    • “Now, the company is updating the branding for its Amerigroup segment to Wellpoint in a bid to better align the government insurance business with its push toward whole health, Elevance Health tells Fierce Healthcare exclusively. The rebrand will roll out in January 2024, pending regulatory approvals, in six states: Arizona, Iowa, New Jersey, Tennessee, Texas and Washington.
    • “Amerigroup plans in Maryland already took on the Wellpoint brand earlier this year. The insurer emphasized that while Amerigroup’s plans may be gaining a new name, the benefits that members enjoy today won’t be changing in tandem.
    • “Felicia Norwood, president of government health benefits for Elevance Health, told Fierce Healthcare that deploying the new name will help “simplify our health plan brands and make it easier for our customers to understand and do business with us over time.”
  • From the patient safety front —
  • STAT News relates
    • “Five elderly people have been blinded in one eye by a severe side effect after receiving injections of a newly approved treatment for eye disease from Apellis Pharmaceuticals. The frequency of this side effect — a severe type of eye inflammation — is low but its cause remains unknown.
    • “The new safety information related to the Apellis drug, called Syfovre, was presented Saturday by a committee of eye disease experts at the annual meeting of the American Society of Retinal Specialists (ASRS).
    • “Apellis cooperated with the ASRS analysis but the company also announced its own internal review Saturday that found fewer cases of retinal occlusive vasculitis, a type of severe eye inflammation that blocks blood flow to the retina and can result in blindness. The rate of retinal occlusive vasculitis reported remains “very rare,” the company said, adding that there is no evidence linking the drug product or its manufacturing to the severe side effect.”
  • The New York Times reports that federal courts have rejected Johnson & Johnson’s bankruptcy defense to the talc class action lawsuits. Johnson & Johnson continues to assert the defense on appeal and elsewhere.

Weekend update

David Ermer–CMS, Federal employment benefits, Medicare, NCQA–

From Washington DC —

  • OPM and its Inspector General remind us that today is National Whistleblower Day.
    • “Whistleblowers play a critical role in promoting accountability and efficiency across the federal government. Federal employees and employees of contractors and grantees can serve as an important resource for identifying fraud, waste, and abuse.”
  • August 15 is OPM’s soft deadline for concluding 2024 benefit and rate negotiations with carriers. OPM has been announcing next year’s FEHB premiums at the end of September.
  • The FEHBlog expects a low government contribution increase for 2024 because OPM authorized Medicare Part D EGWPs in the FEHB for next year. Of course, in future years, the big Part D savings will be baked into FEHB premiums, except for the Inflation Reduction Act changes that are being phased in over the next three to four years.
  • On a related note, the Motley Fool predicts
    • Slowing inflation seems likely to cause Social Security COLAs to be much lower in 2024.
    • Higher Medicare Part B premiums could offset part of the retirees’ Social Security increase.
  • In the FEHBlog’s opinion, the Motley Fool is not going out on a limb because inflation has dropped this year, and CMS gave the green light to Medicare coverage of an expensive Alzheimer’s Disease drug, Leqembi. There’s a chance that Congress may approve Medicare coverage for expensive but effective weight loss drugs, i.e., Wegovy.

More from the Medicare front

  • Fierce Healthcare reports
    • “Most Medicare Advantage (MA) enrollees use one or more supplemental benefits, with most health plan members using multiple benefits, according to a newly released report from the Elevance Health Public Policy Institute.
    • “The report finds that 83% of dual-eligible and 75% of non-dual-eligible individuals used at least one supplemental benefit a year. Those figures only drop to 64% and 48%, respectively, for using at least two different supplemental benefits. It also concluded that dual-eligible enrollees were more likely to live in a food desert, so they are more likely to self-select plans with strong supplemental benefit offerings.”
  • and
    • “Researchers found that once joining Medicare, patients are 50% more likely to get health screenings for breast cancer and colorectal cancer.
    • “Patients with other undiagnosed diseases, such as depression, COPD, type 2 diabetes, lung or prostate cancer, hypertension and hyperlipidemia, are also more likely to discover their condition in their first year of being on Medicare coverage.
    • “The report, by Epic Research, reviewed more than 20 million patients between the ages of 60 and 70 to see whether diagnoses occurred more frequently.
    • “Breast cancer screening rates jump from 15.3% to 30.4%, while colorectal cancer screening rates increase from 4.8% to 11%.”

On a related note, NCQA released its measurement year 2022 Quality Compass for commercial plans, which category includes FEHB plans, on July 28.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI, Uncategorized–

From the cybersecurity policy front —

  • Cyberscoop reports
    • “President Biden on Wednesday nominated Harry Coker, a long-time CIA and National Security Agency official, to serve as the next national cyber director, a choice that elevates a relatively unknown official to take on a high-profile assignment as the president’s leading cybersecurity adviser. 
    • “Coker’s nomination ends a protracted search to replace Chris Inglis, who led the Office of the National Cyber Director until February after leading efforts to draft the administration’s cybersecurity strategy. 
    • “Leading voices in Capitol Hill have urged Biden in recent weeks to nominate Inglis’s deputy, Kemba Walden, who has been serving as the acting director. Despite the support of key lawmakers, the White House passed on elevating Walden to the permanent position — reportedly out of concern that her significant financial debts might hinder her confirmation before the Senate.”
  • The Cybersecurity and Infrastructure Security Agency tells us,
    • “Now that the cross-sector CPGs have been published, CISA is working with Sector Risk Management Agencies (SRMAs) to directly engage with each critical infrastructure sector to develop Sector-Specific Goals (SSGs).  In most instances, these goals will likely consist of either new, unique additional goals with direct applicability to a given sector or, materials to assist sector constituents with effective implementation of the existing cross-sector CPGs. Sector-specific goals will be developed by:
    • “Identifying any additional cybersecurity practices not already included in the Common Baseline, needed to ensure the safe and reliable operation of critical infrastructure in that sector.  
    • “Providing examples for recommended actions specific to the infrastructure and entities in that sector; and  
    • “Mapping any existing requirements (e.g., regulations or security directives) to the Common Baseline and sector-specific objectives and/or recommended actions so stakeholders can see how their existing compliance practices fulfill certain objectives.  
    • “As there are 16 Critical Infrastructure sectors with varying needs, CISA will be tackling this effort in several phases. The first four sectors CISA is working with include the Energy, Financial Services, IT, and Chemical Sectors. In addition, CISA will be working throughout the year with the Water/Wastewater Sector, Healthcare Sector, and K-12 Subsector on identifying approaches for how organizations in those sectors/subsectors can enhance their cybersecurity posture through the implementation of the existing body of cross-sector goals.”
  • Here is a link to the website for the healthcare sector coordinating council (HSCC), whose work the FEHBlog will begin to track. Surprisingly to the FEHBlog, OPM is not an HSCC member.

From the cybersecurity breaches and vulnerabilities front —

  • Cybersecurity Dive informs us,
    • “Healthcare continues to be the most expensive industry for data breaches, beating out other sectors for the 13th year in a row, according to research conducted by the Ponemon Institute and published by IBM Security. 
    • “The average cost of a healthcare data breach reached nearly $11 million in 2023, an increase of 8% from last year and a 53% jump since 2020, the report found. 
    • “Although the healthcare sector faces high levels of industry regulation, expenses accrued from data breaches in the sector were almost double compared to the financial industry, which saw the second-most expensive data breaches at $5.9 million.”
  • Cybersecurity Dive adds
    • “The investigation phase of data breaches is the fastest growing and costliest category of data breach expenses, contributing to the consistent year-over-year increase in costs. Detection and escalation costs jumped almost 10% to nearly $1.6 million per incident, IBM found.
    • “The breadth and depth of incident response investigations are scaling up directly with the overall costs, along with the off tempo of the criminal,” John Dwyer, head of research at IBM Security X-Force, told Cybersecurity Dive.”
  • On a related topic, Cybersecurity Dive lets us know,
    • “Valid account credentials are at the root of most successful threat actor intrusions of critical infrastructure networks and state and local agencies, according to the Cybersecurity and Infrastructure Security Agency.
    • “Valid credential compromise combined with spear-phishing attacks accounted for nearly 90% of infiltrations last year.
    • Valid accounts, including former employee accounts, not removed from the Active Directory and default administrator credentials, were responsible for 54% of all attacks studied in the agency’s annual risk and vulnerability assessment released Wednesday.
    • Spear-phishing links — malware-laced emails sent to targeted individuals — were responsible for 1 in 3 attacks, the report found.
    • The success rate of these techniques underscores the staying power of the most common methods threat actors use to gain initial access to targeted systems.
  • Cyberscoop relates
    • “Apple on Monday issued its third security update in roughly a month to remedy vulnerabilities exploited in Operation Triangulation, a spyware campaign that researchers say specifically targeted iMessage users in Russia. 
    • “The Russian arm of cybersecurity firm Kaspersky on June 1 revealed the details of a zero-click iOS exploit. The company’s researchers said they discovered it while monitoring the company’s own corporate Wi-Fi network dedicated to mobile devices. The findings were released the same day Russia’s Federal Security Service, or FSB, said it had uncovered an American espionage operation targeting Apple devices in Russia in cooperation with Apple. 
    • “Apple told CyberScoop at the time that it had “never worked with any government to insert a backdoor into any Apple product and never will.”
  • Per Cyberscoop,
    • “Executives, researchers and engineers at big tech companies and startups alike working on artificial intelligence face a growing threat from criminal and nation-state hackers looking to pilfer intellectual property or data that underlies powerful chatbots, the FBI warned on Friday.
    • “The growing risk coincides with the increasing availability of AI tools and services to the general public in the form of products such as OpenAI’s ChatGPT, or Google’s Bard, for instance, as well as the increasing ease and ability for many companies to develop AI language models.
    • “The warning comes two days after FBI Director Christopher Wray and Bryan Vorndran, the agency’s assistant director, cyber division, warned about the distinct AI-related threats from China, which political leaders in the U.S. and Europe have long warned wants to dominate all aspects of AI research and implementation.”
  • Per Security Week,
    • “New guidance from the Australian Cyber Security Centre (ACSC), the US Cybersecurity and Infrastructure Security Agency (CISA), and National Security Agency (NSA) warns developers, vendors, and organizations of access control vulnerabilities in web applications.
    • “Described as insecure direct object reference (IDOR) issues, they allow threat actors to read or tamper with sensitive data via application programming interface (API) requests that include the identifier of a valid user.
    • “These requests are successful because the authentication or authorization of the user submitting the request is not properly validated, the three agencies explain.”
  • CISA added an additional known exploited vulnerability to its catalog on July 25, July 26, and July 27, 2023.
  • Yesterday CISA “published three malware analysis reports on malware variants associated with the exploitation of CVE-2023-2868. CVE-2023-2868 is a remote command injection vulnerability affecting Barracuda Email Security Gateway (ESG) Appliance, versions 5.1.3.001-9.2.0.006. It was exploited as a zero-day as early as October 2022 to gain access to ESG appliances. According to industry reporting, the actors exploited the vulnerability to gain initial access to victim systems and then implanted backdoors to establish and maintain persistence.”
  • Also, yesterday, CMS shared its MOVEIt breach notice to Medicare beneficiaries.

From the ransomware front —

  • HelpNet Security points out that “In the Q2 2023, GuidePoint Research and Intelligence Team (GRIT) tracked 1,177 total publicly posted ransomware victims claimed by 41 different threat groups.”
  • Here is a link to yesterday’s The Week in Ransomware from Bleeping Computer.
    • “With ransom payments declining, ransomware gangs are evolving their extortion tactics to utilize new methods to pressure victims.
    • “This was seen by both the Clop and BlackCat/ALPHV ransomware gangs, who began utilizing new tactics as part of their extortion schemes.
    • “Clop has begun to create clear websites to leak data stolen during the MOVEit Transfer attacks, similar to a tactic introduced by ALPHV in 2022.”

From the cybersecurity defenses front —

  • TechRepublic shares cybersecurity defense ideas included in the Ponemon/IBM report.
  • Forbes offers a cybersecurity expert’s view on adopting a new paradigm in cybersecurity stemming from this conundrum:
    • Today, companies that house secure data and information are encountering an accessibility dilemma: On the one hand, they face an increased need for security and privacy of data, particularly as cyber threats become self-generating and more sophisticated. On the other hand, the value in securing assets lies in being able to utilize them, share them, and transact them effectively and efficiently with intended stakeholders so as to improve customer service and attain competitive differentiators. Companies struggle to balance these needs with the imperative to secure these data, particularly in accordance with certain industry standards or digital privacy regulations

End of Week Update

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

From Washington, DC

  • Roll Call offers the history of the August Congressional recess, which began on Thursday. The recess gives the staff time to prepare for the big September legislative push.
  • Roll Call adds
    • “Days after it was passed by the House, the Senate cleared legislation Thursday evening that aims to overhaul the organ transplant system in the United States.
    • “The bill now goes to President Joe Biden’s desk for his signature.
    • “The bill would give the Department of Health and Human Services the authority to expand competition for contracts related to the operation of the Organ Procurement and Transplantation Network, which matches donor organs with patients waiting for transplants.
    • “The legislation comes as the Biden administration moves to open up the contracting process that has allowed one company to manage the system for nearly 40 years, despite claims of mismanagement that has allowed patients to die on waiting lists.
    • “The management of the U.S. organ transplant system needs serious reform,” said Sen. Bill Cassidy, R-La., a co-sponsor of the Senate companion version of the bill and the ranking member of the Senate Health, Education, Labor and Pensions Committee. “Breaking up this monopoly will increase competition, save lives and improve the system. Glad to see our legislation pass Congress and look forward to it becoming law.”
  • NBC News and STAT News let us know that both Houses of Congress are preparing legislation to hopefully solve the Nation’s widespread drug shortage.
  • AHA News adds,
    • “In the wake of tornado damage last week to a large Pfizer sterile injectables plant in North Carolina, the Food and Drug Administration July 28 posted a list of products made at the facility that have less than three months of inventory in the supply chain. According to Pfizer, there does not appear to be any major damage to production areas at the 250-acre site, but about 40,000 pallets of supplies and finished goods stored in the facility’s high-rise warehouse were damaged. The company said it is working to restart production and explore alternative manufacturing locations and will update the information as it learns more. Meanwhile, the company said it is allocating products in its hospital portfolio.”
  • Also, per AHA News
    • “The Centers for Medicare & Medicaid Services July 28 issued its final rule updating hospice payments for fiscal year 2024. CMS finalized a 3.1% ($780 million) net increase to FY 2024 payments as compared with FY 2023. This update includes a 3.3% market basket, reduced by a 0.2% productivity adjustment.”
  • The Food and Drug Administration approved
    • “RiVive, 3 milligrams (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose. This is the second nonprescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription. The timeline for availability and the price of this nonprescription product will be determined by the manufacturer.”

From the U.S. healthcare business front —

  • Beckers Payer Issues informs us that health insurer “Centene recorded $1.06 billion in net income in the second quarter of 2023 after recording a $172 million loss over the same period last year, according to the company’s earnings report released July 28.”
  • BioPharma Dive reports
    • “Biogen is making one of the biggest business bets in its 45-year history, announcing Friday a deal to buy Reata Pharmaceuticals and its newly approved rare disease drug for approximately $7.3 billion.
    • “The Cambridge, Massachusetts-based biotechnology company will pay $172.50 per Reata share, which represents a premium of about 59% over the stock’s closing price Thursday. Biogen expects to fund the deal with cash on hand as well as additional debt.
    • “Acquiring Reata gives Biogen access to Skyclarys, a drug for the neuromuscular condition Friedreich’s ataxia that gained U.S. approval in March. The disease is uncommon, affecting an estimated 5,000 people in the U.S. And its clearance was controversial, following years of back-and-forth with the Food and Drug Administration.”
  • and
    • “AstraZeneca has reached a deal to acquire a group of early-stage gene therapy programs and related technologies from Pfizer, the British drugmaker’s most significant move to date in the field of genetic medicine.
    • “Per deal terms, AstraZeneca’s rare disease division Alexion will pay up to $1 billion to acquire the programs and novel “capsids,” the protein shells that protect gene therapies as they’re delivered into the body. AstraZeneca intends to use those capsids to develop genetic therapies with “improved safety and efficacy profiles,” the company said Friday.
    • “AstraZeneca will pay royalties on sales of any commercial products that arise from the deal. Alexion also intends to “welcome talent from Pfizer” who were working on the research, an area the drugmaker has cut back on in favor of more advanced gene therapy programs.”
  • Per BNA News,
    • “Employer-sponsored health plans are investigating the possibility of organizing risk pools to help finance the high cost of prescription drugs.
    • “They are eyeing asking for government help in setting up risk pools that would help cover costs for so-called orphan drugs that treat rare diseases, as well as for high-cost gene and cell therapies. Risk pools are funds collected from groups of employers that would be used to pay for high-cost drugs.
    • “Employers are particularly worried about high-cost drugs that can run more than $1 million. Even with stop-loss insurance, which covers high claims costs, employers can end up footing the bill after a drug is covered the first year.”