FEHBlog

Cybersecurity Saturday

David Ermer–Cybersecurity, Uncategorized–

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports
    • “An international law enforcement operation disrupted the Qakbot botnet and associated malware that has been connected with countless cyberattacks and nearly $60 million in losses from victims around the world, the U.S. Department of Justice announced Tuesday. 
    • “The operation that included the FBI, DOJ and authorities in France, Germany, the Netherlands, Romania, Latvia and the United Kingdom — is “one of the largest U.S.-led disruptions of a botnet infrastructure” used by criminals to facilitate ransomware, financial fraud and other cyber-enabled criminal activity, the FBI said in a statement.
    • “There were no arrests in connection with the operation but the investigation remains ongoing, a senior FBI official told reporters Tuesday.
    • “Qakbot, also known as Qbot or Pinksipbot, is malware first detected in 2008 that has been associated with hundreds of millions of dollars in losses to individuals and businesses in the U.S. and around the world, according to the FBI. The malware has been an initial entry mechanism for a variety of ransomware groups over the years. Groups such as Conti, ProLock, Egregor, REvil, MegaCortex and Black Basta have been known to use it. Between October 2021 and April 2023, the FBI said, Qakbot administrators have received fees corresponding to approximately $58 million in ransoms paid by victims.
  • Cybersecurity Dive adds
    • “The FBI was able to redirect botnet traffic toward servers it controlled and disrupt the operation. More than 200,000 computers in the U.S. alone were found to be infected. Authorities also seized $8.6 million in illicit cryptocurrency as part of the takedown. ***
    • “The FBI and Dutch National Police have set up website links where stolen credentials can be accessed to find out if they were used.” 
  • Here are links to the related CISA announcement and Security Week’s report on industry reaction to this news.
  • Krebs on Security informs us,
    • “Domain names ending in “.US” — the top-level domain for the United States — are among the most prevalent in phishing scams, new research shows. This is noteworthy because .US is overseen by the U.S. government, which is frequently the target of phishing domains ending in .US. Also, .US domains are only supposed to be available to U.S. citizens and to those who can demonstrate that they have a physical presence in the United States.
    • “.US is the “country code top-level domain” or ccTLD of the United States. Most countries have their own ccTLDs: .MX for Mexico, for example, or .CA for Canada. But few other major countries in the world have anywhere near as many phishing domains each year as .US.
    • “That’s according to The Interisle Consulting Group, which gathers phishing data from multiple industry sources and publishes an annual report on the latest trends. Interisle’s newest study examined six million phishing reports between May 1, 2022, and April 30, 2023, and found 30,000 .US phishing domains.
    • “.US is overseen by the National Telecommunications and Information Administration(NTIA), an executive branch agency of the U.S. Department of Commerce. However, NTIA currently contracts out the management of the .US domain to GoDaddy, by far the world’s largest domain registrar.”
  • Go figure.
  • Cybersecurity Dive tells us last Monday
    • “The blast radius from the mass exploit of a zero-day vulnerability in the MOVEit file transfer service reached another milestone in its destructive spread: more than 1,000 organizations are impacted, according to Emsisoft and KonBriefing Research.
    • “The number of organizations hit by the wide-scale attack increased nearly 40% last week, underscoring the scope of impact and challenge organizations are encountering as they work to determine potential exposure.
    • “The pool of victims from Clop’s attack spree, which was discovered Memorial Day weekend, continues to grow as downstream victims, which lead to more downstream victims, are identified via public disclosures and the threat actor’s website.
  • Health IT Security adds
    • “This week, Singing River Health System in Mississippi is actively facing system downtime as it investigates a cyberattack on its network. What’s more, Prospect Medical Holdings, which operates 16 hospitals and more than 165 clinics across Southern California, Rhode Island, Pennsylvania, and Connecticut, is still experiencing a systemwide outage that began on August 9.
    • “As these incidents continue to develop, other entities have continued to report confirmed data breaches to HHS, as exemplified in this week’s data breach roundup. Third-party data breaches continue to dominate breach notifications, causing breaches across the country.”
    • The article goes on to highlight recent breach announcements. 

From the cybersecurity defenses front,

  • Per Cybersecurity Dive,
    • “Organizations are facing more obstacles obtaining or renewing cyber insurance coverage,  according to a survey of 300 organizations conducted by Censuswide, on behalf of Delinea. Organizations also face strict requirements to get a claim covered.
    • “The majority of organizations, 4 in 5,  said their insurance rates went up when they submitted a new application or applied for policy renewals, with two-thirds reporting premium hikes of between 50% and 100%. 
    • “It is also taking organizations longer to obtain new coverage. The process for 20 of those surveyed, roughly 7%, took six months or longer.”
  • The Healthcare and Public Sector Critical Infrastructure Security and Resilience Partnership released an updated version of its Health Industry Cybersecurity Tactical Crisis Response Guide.
  • An ISACA expert discusses “Contending with Artificially Intelligent Ransomware.”
  • HHS’s 405(d) group released a cyber-hygiene poster oriented toward healthcare providers. Nevertheless, it can be adapted for health plan use.
  • Forbes identifies ten “captivating” cybersecurity conferences being held in Fall 2023.

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, Electronic health records, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • “Nursing homes will have to maintain minimum staffing levels under a Biden administration proposal despite furious lobbying from the industry, which says it will be too onerous amid a continuing labor shortage.
    • “Biden administration officials said the first-ever national staffing rule would require nursing homes that participate in Medicare and Medicaid to provide a minimum of 0.55 hours of care from a registered nurse per resident a day, and 2.45 hours of care from a nurse aide per resident a day. A registered nurse would be required to be on-site at all times and nursing-home care assessments would be strengthened under the proposal.
    • “The Centers for Medicare and Medicaid Services estimates that about 75% of nursing homes would have to strengthen staffing in their facilities under the proposal. The proposed staffing standard exceeds those existing in nearly all states.”
  • and
    • “The Federal Trade Commission said Friday it had agreed to end its legal challenge of drugmaker  Amgen’s $27.8 billion deal to buy  Horizon Therapeutics, averting a trial that was to have started this month.
    • “The pact also dismisses the antitrust claims of six states that joined the FTC in May seeking to block the deal over concerns that Amgen would illegally bundle its products with Horizon’s medicines for thyroid eye disease and gout. Amgen agreed in the proposed settlement not to bundle the Horizon treatments and swore off conditional rebates or other tactics that could entrench the monopoly position of Horizon’s products.”
  • HHS Secretary Xavier Berra made a statement recognizing National Suicide Awareness Month.
    • “The Biden-Harris Administration is deeply committed to tackling the mental health crisis facing America, particularly the alarming rates of suicide. Recognizing the urgency of this issue, SAMHSA continues to support the Suicide Prevention Resource Center and consistently invests millions in suicide prevention initiatives. In fact, SAMHSA will award nearly $12 million to the Zero Suicide in Health Systems program next week. This ambitious program aims to comprehensively integrate the Zero Suicide intervention and prevention model across various health systems with the express aim of reducing suicide ideation, suicide attempts, and deaths due to suicide.
    • “But no program exemplifies our work to prevent suicide better than 988, the three-digit Suicide & Crisis Lifeline, which HHS launched in collaboration with the states in 2022. The Biden-Harris Administration has invested close to $1 billion in 988, and, thanks to 988, Americans are now connected with trained counselors who offer real support in times of crisis. Since the July 2022 launch, 988 has received more than 5.5 million calls, texts, and chats, and this July, text and chat were made available in Spanish.”
  • Per Fierce Healthcare,
    • Enforcement of information blocking penalties for health IT entities [went] into effect on Friday, opening the door to penalties of up to $1 million per violation.
    • The breakdown of how exactly the Department of Health and Human Services (HHS) Office of Inspector General (OIG) will prioritize what it expects to be a deluge of information-blocking complaints was posted by the regulator in late June.

From the public health front,

  • The Wall Street Journal discusses “Covid This Fall: What’s the Same, What’s Different and What to Know.”
  • The Hill adds
    • “COVID-19 hospitalizations have steadily increased over the past few weeks, reaching 15,067 for the week ending Aug. 19 — an 18.8 percent increase from the week prior, according to CDC data. But at this time last year, the U.S. averaged over 84,000 hospitalizations per week. More than 96 percent of U.S. counties are experiencing low COVID-19 hospitalization levels, at less than 10 new COVID-19 hospital admissions per 100,00 people.”
  • Per Beckers Hospital Review,
    • “The CDC updated its risk assessment on distant omicron relative BA.2.86 on Aug. 30, saying the strain — which has concerned experts over the large number of mutations it carries — has been detected in at least four states. 
    • “CDC continues to track the presence of the BA.2.86 [COVID-19] variant,” the update said. “Since CDC’s initial risk assessment, this variant has been identified in additional countries from both human and wastewater specimens.” 
    • “In the U.S., BA.2.86 cases have been detected in Virginia, Michigan, Ohio and New York either through human samples or wastewater samples. Separately, Houston Methodist in an Aug. 31 statement emailed to Becker’s said it has identified Texas’ first reported instance of BA.2.86 through genomic sequencing. The hospital’s COVID-19 sequencing team continues to sequence all positive specimens.” 
  • The New York Times Morning column provides an overview of Fall 2023 Covid, flu and now RSV vaccines. Of note, at least to the FEHBlog,
    • “This year’s flu vaccine shots are now available at drugstores, hospitals, doctor’s offices and elsewhere. You may want to wait until late September or October to get one, though. The heaviest parts of flu season tend to occur between December and February. If you wait, the shot’s protection against severe illness will still be near its strongest level during those months.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Walgreens chief executive Rosalind Brewer is stepping down as CEO and a member of the board effective immediately, the retail pharmacy giant announced Friday.
    • “Brewer’s departure comes less than three years after she joined the Illinois-based retailer. The parting was a mutual decision between Brewer and Walgreens’ board, according to a release. Walgreens’ lead independent director Ginger Graham will serve as interim CEO while the company looks for a permanent replacement.”
  • STAT News discusses the “curious case of J&J’s Stelara, the unluckiest drug on Medicare’s list” of ten drugs subject to CMS “price negotiation.” Bad beat.

Thursday Miscellany

David Ermer–CMS, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC,

  • The Washington Post reports
    • “The White House on Thursday urged Congress to adopt a short-term measure to fund the federal government, a move meant to buy time for lawmakers to craft a broader spending deal and avert a shutdown at the end of September.
    • “The Biden administration coupled its call to action with a new request that Congress address funding for a series of cash-starved programs — including, for example, an additional $1.4 billion to prevent a potential disruption in nutritional aid for low-income families.”
  • HHS Secretary Xavier Berrara reflected on the Administration’s efforts to end the opioid public health emergency on this International Overdose Awareness Day.
  • In related news, the New York Times informs us
    • “Narcan, the first opioid overdose reversal medication approved for over-the-counter purchase, is being shipped to drugstore and grocery chains nationwide, its manufacturer said Wednesday. Big-box outlets like Walgreens, CVS, Walmart and Rite Aid said they expected Narcan to be available online and on many store shelves early next week.
    • “Public health experts have long called for greater accessibility to the drug, which they describe as a critical weapon against rising overdose rates. There were more than 100,000 opioid overdose fatalities in each of the last two years in the United States.
    • “Narcan is already a staple for emergency personnel and street outreach teams. Now scientists and health officials are hoping Narcan will eventually become commonplace in public libraries, subways, dorms, corner delis and street vending machines.
    • “They also predict it may become a fixture in medicine cabinets, as more people realize that illicit party drugs like cocaine and counterfeit Xanax pills may be tainted with deadly fentanyl, an opioid.”
  • Govexec relates
    • “President Biden on Thursday formalized his plan to provide civilian federal employees with an average 5.2% pay increase, their largest in four decades, in a letter to congressional leaders.
    • “In March, Biden first announced his pay raise plan as part of his fiscal 2024 budget proposal, recommending the largest pay increase for civilian federal workers since the Carter administration. Thursday’s announcement confirms that, if implemented, federal employees will see an across-the-board increase in basic pay of 4.7% and an average 0.5% boost to locality pay.
    • “In his letter, Biden said the pay raise is critical to his administration’s goal of ensuring that the federal government is a model employer and able to attract qualified candidates to join the workforce.”
  • The U.S. Office of Personnel Management announced issuing
    • the final regulations to implement the Fair Chance to Compete for Jobs Act of 2019 (Fair Chance Act), which prohibits federal agencies and federal contractors from requesting an applicant’s criminal history information before the agency makes a conditional offer of employment to the applicant. The final regulations also provide applicants with a complaint process and hold accountable federal employees who are in violation of the Fair Chance Act. 
    • “If you have the qualifications, skills, and willingness to serve the American public, you deserve a fair chance to compete for employment within the federal government,” said Kiran Ahuja, OPM Director. “America is a nation of second chances, and every person deserves to be treated with dignity and respect.” 

From the Medicare front,

  • MedPage Today reports on CMS efforts to recruit specialty practices in Medicare value-based purchasing programs.
  • Milliman issued a white paper titled “Part D redesign under the Inflation Reduction Act / Potential financial ramifications for Part D plans and pharmaceutical manufacturers.” Check it out.
  • CMS recently announced
    • “a new voluntary nationwide model – the Guiding an Improved Dementia Experience (GUIDE) Model – a model test that aims to support people living with dementia and their unpaid caregivers. CMS is accepting letters of interest for the GUIDE Model through September 15, 2023, and will release a GUIDE Request for Applications (RFA) for the model in Fall 2023. The model will launch on July 1, 2024, and run for eight years. * * *
    • “Participants in the GUIDE Model will establish dementia care programs (DCPs) that provide ongoing, longitudinal care and support to people living with dementia through an interdisciplinary team. GUIDE participants will be Medicare Part B enrolled providers/suppliers, excluding durable medical equipment (DME) and laboratory suppliers, who are eligible to bill for Medicare Physician Fee Schedule services and agree to meet the care delivery requirements of the model.”

From the public health and medical research fronts

  • We have four articles from STAT News
    • Miscarriage treatment news. “A [Woodbury,] Minnesota clinic tries to rewrite medicine’s approach to miscarriage.” Bravo.
    • CAR-T Therapy News — “Saar Gill and Carl June, cell therapy researchers at the University of Pennsylvania, wanted to make a single treatment that could tackle virtually all blood cancers. It was an audacious goal. * * *
    • “On Thursday, though, Gill, June and a graduate student, Nils Wellhausen, published a solution in Science Translational Medicine. It’s a complicated dance involving a new form of genome editing and multiple cellular infusions, and still years away from clinical trials. But outside experts say that if academics or companies can figure out manufacturing and logistics, it could open new avenues to tackling cancers that have so far remained out of reach.
    • “It’s very clever and really a tour de force,” said Marcela Maus, director of the cellular immunotherapy program at Mass General Hospital.”
    • Depression treatment news — “A single dose of psilocybin may have enduring benefits for people with major depressive disorder, according to a randomized clinical trial published Thursday in the Journal of the American Medical Association.”
    • AD Treatment News — Drug firms are studying whether drugs like Leqembi can halt Alzheimer’s Disease before symptoms appears.
  • From the U.S. healthcare business front,
    • Per Fierce Healthcare,
      • “GoodRx has launched a new feature to allow healthcare professionals to see the cost of a patient’s prescription with their insurance.
      • “The real-time benefit check (RTBC) feature was developed in collaboration with AssistRx, a specialty therapy initiation and patient solutions provider. The RTBC surfaces a patient’s coverage and benefits at the point of care with the goal of increasing price transparency and access to drugs. It also includes whether a prior authorization is required.
      • “AssistRx built its advanced access and patient support solutions to be interoperable, Edward Hensley, the company’s co-founder and chief commercial officer, said in a press release.”

Midweek update

David Ermer–FDA, Generative AI, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC,

  • “Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra declared a Public Health Emergency (PHE) for the state of Florida to address the health impacts of Hurricane Idalia and the Administration for Strategic Preparedness and Response (ASPR) deployed approximately 68 emergency response personnel to the state. At President Biden’s direction, HHS is aiding impacted communities through the Administration’s whole-of-government response effort.”
  • The Society for Human Resource Management informs us,
    • “The Department of Labor (DOL) has proposed an increase to the Fair Labor Standards Act’s (FLSA’s) annual salary-level threshold to $55,068 from $35,568 for white-collar exemptions to overtime requirements. The department also is proposing automatic increases every three years to the overtime threshold. * * * *
    • “To be exempt from overtime under the FLSA’s “white-collar” executive, administrative and professional exemptions, employees must be paid a salary of at least the threshold amount and meet certain duties tests. If they are paid less or do not meet the tests, they must be paid 1 and a half times their regular hourly rate for hours worked in excess of 40 in a workweek. * * *
    • “Under the new rule, approximately 300,000 more manufacturing workers would be entitled to overtime pay, the Labor Department reports. A similar number of retail workers would be eligible, along with 180,000 hospitality and leisure workers, and 600,000 in the health care and social services sector.” 
  • MedCity News relates,
    • “A Bristol Myers drug that treats anemia caused by a type of blood cancer now has an FDA approval that moves it up in the hierarchy of treatments, expanding the eligible patient population and positioning the therapy to achieve its blockbuster expectations.
    • “The drug, Reblozyl, treats myelodysplastic syndromes (MDS), a group of cancers in which the immature blood cells in bone marrow do not mature to become healthy blood cells. In 2020, the FDA approved Reblozyl as a second-line treatment for the anemia resulting from MDS. The FDA decision announced late Monday makes it a first-line therapy.”
  • The National Institutes of Health announced,
    • “In a study of 152 deceased athletes less than 30 years old who were exposed to repeated head injury through contact sports, brain examination demonstrated that 63 (41%) had chronic traumatic encephalopathy (CTE), a degenerative brain disorder associated with exposure to head trauma. Neuropsychological symptoms were severe in both those with and without evidence of CTE. Suicide was the most common cause of death in both groups, followed by unintentional overdose.
    • “Among the brain donors found to have CTE, 71% had played contact sports at a non-professional level (youth, high school, or college competition). Common sports included American football, ice hockey, soccer, rugby, and wrestling. The study, published in JAMA Neurology, confirms that CTE can occur even in young athletes exposed to repetitive head impacts. The research was supported in part by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.” 

From the public health, medical research and Rx coverage fronts,

  • STAT News reports,
    • “The first Alzheimer’s therapy to clearly slow cognitive decline, approved in the United States last month, lifted the hope of patients and their families. But creating access to the program is a painfully slow process, even in Massachusetts, where large hospital systems have been preparing for months to administer the much-anticipated medicine.
    • “Thousands of patients are stuck on waiting lists across the state and nationally as hospitals struggle to ramp up infusion centers and monitoring processes for the drug, called Leqembi, while neurologists grapple with workforce and capacity constraints. * * *
    • “Hospitals say the backlog is temporary, reflecting the challenge of building from scratch a treatment infrastructure for new Alzheimer’s drugs. Leqembi, developed by Biogen and its Japanese partner, Eisai, was the first such treatment to be green-lighted by the Food and Drug Administration. The agency will evaluate a second therapy, Eli Lilly’s donanemab, later this year.”
  • and
    • “KRAS, one of the most common genetic mutations in cancer, has been one of the most tantalizing oncogenic targets for drug developers since its discovery four decades ago. An altered KRAS gene can drive cells to divide uncontrollably, propelling them down the path towards malignancy. But for most of the last four decades, any attempt to target KRAS failed, leading many researchers to doom the protein as “undruggable.”
    • “In the last few years, that attitude has sharply turned around. In 2013, Kevan Shokat, a biologist at the University of California, San Francisco, discovered a key chemical vulnerability in a specific subset of mutant oncogenic KRAS that made it possible to design small molecules that would bind to the protein. This discovery catalyzed a frenzy of drug development around KRAS inhibitors, which eventually led to the first approved KRAS drugs in the last couple of years. Those successes are now driving a new wave of early-stage innovation around the target.
    • “It broke the code for us, for KRAS,” said Ravi Salgia, chair of medical oncology and therapeutics research at the City of Hope. “That gives us more hope to say we’ve spent more than 30 years studying it. Now, great breakthroughs have occurred. Let’s keep going forward.”
    • “That includes work around new small molecules for other subsets of mutant KRAS as well as immunotherapy approaches for targeting the oncogene. These therapies could potentially treat a wide range of different KRAS-mutant cancers including lung, pancreas, and colorectal cancers.”
  • CNN tells us,
    • “A group of novel synthetic opioids emerging in illicit drugs in the United States may be more powerful than fentanyl, 1,000 times more potent than morphine, and may even require more doses of the medication naloxone to reverse an overdose, a new study suggests.
    • “Nitazenes are a synthetic opioid, like fentanyl, although the two drugs are not structurally related. In the small study published Tuesday in the journal JAMA Network Open most of the patients who overdosed on nitazenes received two or more doses of the opioid overdose reversal drug naloxone, whereas most patients who overdosed on fentanyl received only a single dose of naloxone.
    • “Clinicians should be aware of these opioids in the drug supply so they are adequately prepared to care for these patients and anticipate needing to use multiple doses of naloxone,” the researchers, from the Icahn School of Medicine at Mount Sinai in New York, Lehigh Valley Health Network based in Pennsylvania, and other US institutions, wrote in the study. “In addition, to date there has been a lack of bystander education on repeat naloxone dosing.”

From the U.S. healthcare business front,

  • Per Healthcare Dive, and the FEHBlog agrees,
    • “Ensuring workers can find and access high-quality providers is key to tamping down healthcare costs and improving outcomes in the employer-sponsored insurer market, according to a study by Morgan Health and Embold Health published in NEJM Catalyst. 
    • “Employers can now access more data on the quality of care provided by clinicians, so they should take a larger role in health plan network design and steer workers toward higher-performing providers, according to the report. 
    • “Clinician quality can drive poor outcomes, missed treatments and unnecessary care, the report said. For example, among the top 10% of about 800 cardiologists in Ohio by quality rank, an average of 73% of patients with coronary artery disease were taking cholesterol-lowering statins regularly, compared with only 39% for the bottom 10% of clinicians.” 
  • The Wall Street Journal reports
    • “In a male-dominated industry, female surgeons spend more time in the operating room, and their patients endure fewer postoperative complications.
    • “That’s the conclusion of two research studies published Wednesday in JAMA Surgery. Researchers found better outcomes for patients treated by female surgeons in the sweeping reviews of millions of procedures in Canada and Sweden. 
    • “In the first study, 17 researchers in the U.S. and Canada followed the outcomes for 1.2 million patients in Canada undergoing common surgeries between 2007 and 2020.
    • “The study authors found that at both 90 days and one year following surgery, patients treated by female surgeons were less likely to experience adverse postoperative issues, including death. The outcome differences were modest, but consistent.”
  • Fierce Healthcare relates,
    • “Earlier this year, Anthem Blue Cross and Blue Shield unveiled a new virtual-first plan that harnesses artificial intelligence to streamline health services for members, the insurer announced.
    • “Now, it’s making that plan available in several additional states beginning Jan. 1. Large group fully insured or self-funding employer clients in Connecticut and Virginia can select Anthem Link Virtual First plans, which harness the power of the insurer’s Sydney app to connect members with benefits details, cost transparency information and more around the clock.
    • “Stephanie DuBois, a spokesperson for Anthem Blue Cross and Blue Shield in Connecticut, told Fierce Healthcare in an email that the plans first became available to large group self-insured employers in California, Missouri and New York as well as large group self-funded and fully insured employers in Georgia starting in July.
    • “Members can access Anthem Link Virtual First plans through Sydney Health, which is a digital member engagement platform that includes access to benefits, tools, resources and provider care 24/7,” DuBois said. “Sydney Health also offers an AI-driven symptom checker that intuitively uses the information members provide to narrow down millions of medical data points and assess specific symptoms before seeing a doctor.”

Tuesday’s Tidbits

David Ermer–Electronic health records, Medicare, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “The U.S. government named 10 drugs that will be subject to the first ever price negotiations by Medicare, taking aim at some of the most widely used and costliest medicines in America.
    • “At stake is arguably the government’s strongest effort to date to tackle high drug costs—if drugmakers can’t persuade courts to scuttle the negotiating powers that Medicare was granted last year.
    • “On the list of targeted medicines announced by the Biden administration Tuesday are treatments for cancer, diabetes and heart disease that can cost tens of thousands of dollars a year or more, including blood thinner Eliquis and diabetes treatment Jardiance.”
  • STAT News adds, “The new prices will be announced on Sept. 1, 2024, and will go into effect on Jan. 1, 2026.”   
  • Bloomberg informs us,
    • “For millions of American patients and parents struggling to fill prescriptions for ADHD medications that are in short supply, help is on the way. 
    • “US regulators approved a generic form of Takeda Pharmaceuticals Co.’s Vyvanse, which some patients may be able to take in place of generic Adderall, the drug of choice for many with ADHD. That drug, made by a number of manufacturers, has been in shortage for a year, forcing patients and their families to scour pharmacies for supplies or go without. 
    • “The approval will also likely bring financial relief to the more-than one million Americans who take branded Vyvanse to treat ADHD or binge-eating disorder. The cost of the drug has been steadily climbing since it was introduced in 2007, and today the list price of a 30-day supply is $369.
    • “Generic Vyvanse can be manufactured and sold by 14 companies, according to a Food and Drug Administration database updated Friday [August 25].
  • HC Innovation Group points out,
    • “Leaders at the Sequoia Project, a non-profit, 501c3, public-private collaborative chartered to advanced implementation of secure, interoperable nationwide health information exchange (HIE), announced on Aug. 28 that the Office of the National Coordinator for Health IT (ONC) has confirmed that the Sequoia Project will continue forward as the Recognized Coordinating Entity (RCE) for TEFCA—the Trusted Exchange Framework and Common Agreement. * * *
    • “The Sequoia Project and our RCE team are extremely proud of TEFCA’s progress to date, and we look forward to bringing its promise and benefits to reality soon. We couldn’t have gotten this far without close collaboration with ONC and the candidate QHINs (Qualified Health Information Networks),” said Mariann Yeager, CEO of The Sequoia Project, in a statement contained in the press release. “We’ve engaged stakeholders throughout the development process to engender public trust and instill a sense of ownership for future QHINs. We look to the coming months and years where this multi-year vision becomes a reality.”
  • Everyone in healthcare looks forward to this vision of an EHR backbone becoming a reality.
  • The HHS Office of Inspector General posted a strategic plan for overseeing managed care in the Medicare and Medicaid programs.
  • The U.S. Preventive Services Task Force proposed an inconclusive recommendation for requiring primary care providers “to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment.” The relevant population is “Children and adolescents younger than age 18 years without signs and symptoms of maltreatment.” Public comment is open through September 25, 2023.

From the public health front, McKinsey & Company offers an enlightening exploration of brain health.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Highmark Health reported $13.6 billion in revenue for the first half of 2023 as well as $389 million in net income.
    • “The not-for-profit Blues insurer attributed the performance to positive results at most of its segments, namely its core health plan as well as United Concordia Dental. In addition, volumes at Allegheny Health Network were were up year over year, further driving greater revenue.
    • “The health system reported an 8% increase inpatient discharges and observations compared to the first half of 2022 and a 6% increase in outpatient registrations. Physician visits were also up 6%, and emergency room visits were up 8% across the network.
    • “Earnings before interest, taxes, depreciation and amortization at Allegheny Health Network were $68 million in the first six months of 2023, and the network reported $2.3 billion in operating revenue.”
  • Reuters says,
    • “Pfizer (PFE.N) said on Monday it expects to restart production at its North Carolina plant by the beginning of the fourth quarter of 2023 as it seeks to repair tornado damage to one of the world’s largest sterile injectable drug facilities.
    • “The facility was struck by a tornado on July 19, and Pfizer had earlier said some drugs, including painkiller fentanyl, could see a supply disruption. Pfizer has since placed limits on how much supply of those drugs its customers can buy.”

Monday Roundup

David Ermer–Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front —

  • The Wall Street Journal explains why the new Covid variant BA 2.86 nicknamed Pirola is worth watching.
    • “BA.2.86—dubbed “pirola” by a group of scientists on social media who name notable variants—has been detected in only about a dozen people but it has surfaced in all corners of the world. What’s troubling about this variant, scientists say, is that it contains more than 30 mutations on the spike protein, which is what helps the virus enter cells and cause an infection. This means it might be able to evade current vaccines and previous infections more easily, and it likely won’t be a great match with the fall booster expected to be approved soon.
    • “[Reassuringly,] Scientists say treatments such as the antiviral Paxlovid should still remain effective even with such a highly mutated virus because they target a different part of the virus, not the spike. Rapid antigen tests, often used to test for Covid-19 at home, also should be able to detect the new variant, the CDC said last week.”
  • The Wall Street Journal reports,
    • “Dr. Shoshana Ungerleider knew what her father’s pancreatic cancer diagnosis meant for his future. She didn’t realize what it meant for her own cancer risk. 
    • “Steven Ungerleider’s doctors ordered genetic testing in 2022 to see if his cancer might respond to a new treatment. They found he had a mutation in the BRCA2 gene, which raises risks for cancers including pancreatic, breast and ovarian—and can be passed from parents to children. 
    • “Ungerleider and her sister got tested and discovered they had the same mutation. 
    • “I had no idea that this was possible for me,” said Ungerleider, 43, an internal medicine doctor and founder of End Well, a nonprofit focused on end-of-life care. 
    • “Doctors are recommending genetic tests to more cancer patients and their families. Testing costs have dropped, and the results are helping doctors choose newer targeted drugs and encourage relatives to confront their own cancer risk. 
    • “We can test you for dozens of genes at the same time, and it’s going to influence your treatment,” said Dr. Jewel Samadder, co-leader of the Office of Precision Medicine at the Mayo Clinic Comprehensive Cancer Center in Phoenix.
    • “But few patients or their relatives get tested. Genetic counselors are scarce, and some doctors aren’t up-to-date on genetics training or guidance. After a cancer diagnosis, inherited risk isn’t a priority for many patients. 
    • “It’s an implementation fail,” said Dr. Deborah Schrag, chair of the department of medicine at Memorial Sloan Kettering Cancer Center in New York.”
  • This week, “Oncologist and epidemiologist Vinay Prasad of the University of California, San Francisco, talks to EconTalk’s Russ Roberts about why many tests to detect cancer do little or nothing to extend lifespan.”  The bottom line in 2023 is a point that Russ Roberts makes
    • “I think one of the reasons people screen, even when it’s, quote, “not rational,” or the expected value is zero, is they want to be proactive. They don’t want to have to regret later. They’re afraid that if they don’t screen and then they get terminal cancer, they’ll feel like they were foolish and they made a mistake.”
  • HealthDay informs us,
    • “New research shows that four gut conditions (gastroparesis, dysphagia, constipation and irritable bowel syndrome without diarrhea) are associated with a higher risk of Parkinson’s disease up to five years before diagnosis.
    • “Study findings also suggested that appendix removal may be protective against Parkinson’s.
    • “Researchers noted that the gut conditions implicated are also more prevalent before the onset of Alzheimer’s or cerebrovascular disease.”
  • The American Medical Association tells us what doctors want their patients to know about rheumatoid arthritis.

From the telehealth front,

  • Per Healthcare Dive,
    • In-person and telehealth mental healthcare utilization increased during the COVID-19 pandemic, according to a study of insurance claims published on Friday in JAMA Health Forum.
    • Spending on mental health services increased by 54%, and utilization soared by nearly 40% among commercially insured adults between January 2019 and August 2022.
    • Whether the “disproportionate increase in spending” will remain is an open question, the authors note. Now that the public health emergency has ended, economists are eyeing insurers’ next move to determine whether they will continue or stop coverage for telehealth mental health visits. 
  • As hub-and-spoke-telehealth visits are per se in-network, and only one fifth of mental health providers are in-network, it would be nuts for an insurer to curb telemental visits.
  • mHealth Intelligence reports,
    • “While the majority of telehealth visits do not result in in-person follow-ups within a week, the fraction [11%] of virtual visits that do are for behavioral health and chronic condition issues, new research shows.
    • “Conducted by market research firm Trilliant Health, the analysis aimed to examine the extent to which virtual care is disrupting the patient care journey. The researchers assessed data from the firm’s national all-payer claims database. They determined the percentage of patients who utilized telehealth and had a follow-up visit in person for the same clinical reason within one week.”

From the U.S. healthcare business front,

  • According to Beckers Hospital Review,
    • Rite Aid is preparing to file for Chapter 11 bankruptcy this fall as it faces numerous lawsuits over its alleged role in the opioid epidemic, people familiar with the matter told The Wall Street Journal. 
    • A Chapter 11 bankruptcy filing could alleviate the pharmacy chain’s $3.3 billion debt and legal costs for ongoing opioid lawsuits from private plaintiffs, states and the federal government, according to the Aug. 25 report. Chapter 11 bankruptcies are commonly used to reorganize a company’s structure to continue its business while paying creditors, such as plaintiffs, over time. 
  • The FEHBlog recalls that other large pharmacy chains, including CVS Health, Walgreens and Walmart, settled these class action claims late last year.
  • Becker’s also notes,
    • “Alaska tops the charts when it comes to healthcare costs, with an average yearly expenditure of $13,188 per resident. [Utah comes in at number 50 with an AYE of $7,241 per resident.]
    • “That number comes from Forbes Advisor, which updated its “cost of living by state” analysis on Aug. 23. To determine each state’s average annual healthcare cost, the publication referred to KFF.org’s available healthcare expenditure data, which it averaged from 2018 to 2020. Annual costs refer to the combined price of one’s insurance premium, deductible, copayments, coinsurance and out-of-pocket expenses.” 
  • STAT News points
    • “Over the past year, weight loss drugs have captured the public’s imagination but also raised existential questions about the future of bariatric surgery.
    • “For obesity, surgery has long been — and continues to be — the most effective treatment, reducing patients’ risk of sleep apnea, diabetes, cancer, cardiovascular disease, and death. However, the gap between weight loss drugs and bariatric surgery is starting to narrow after Wegovy cut the risk of major heart complications by 20% in Novo Nordisk’s SELECT trial.
    • “Personally, I would have taken a 5% reduction,” said Angela Fitch, president of the Obesity Medicine Association, emphasizing that these results symbolize a paradigm shift in obesity medicine. With even more effective weight loss drugs already emerging and other clinical trial evidence on the horizon, the hope is that, with medication, “we would see similar sorts of outcomes that we see with surgery,” said Fitch.”
  • Per Fierce Healthcare,
    • “Nationwide hospital finances hit a rough patch in July as reduced patient volumes, a bump in bad debt and charity care whittled operating margins.
    • “That’s the latest from healthcare consulting firm Kaufman Hall, which reported a -1.6% median single-month operating margin index for the industry in July. The decline drove a slight dip in hospitals’ median year-to-date operating margin index to 1.3%.
    • “Still, the firm was quick to note that the hospital industry’s tough month is still a “slight improvement” over the operating margins of 2022.
    • “It’s clear that today’s challenging financial environment is here to stay, and hospital leaders must be proactive in seeking out opportunities to refine their operations and remain competitive,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall and an author of the report, said in a release.
    • “Hospitals’ daily net operating revenues declined 9% from June to July but remain up 7% compared to July 2022. Month-over-month declines to daily inpatient revenue (-3%) paled in comparison to those of daily outpatient revenue (-8%) and were mirrored by reductions in daily adjusted discharges (-7%) and daily operating room minutes (-3%).”
  • BioPharma Dive relates,
    • Danaher plans to buy Cambridge, England-based Abcam for about $5.7 billion in cash, the companies announced on Monday.
    • The acquisition would bring together two firms that make equipment and supplies for life sciences companies. Abcam, with a market capitalization of $5.2 billion, would operate as a standalone company under Washington, D.C.-based Danaher, which has a market cap of $191.7 billion. 
    • Danaher reportedly outbid other companies including Agilent Technologies, Reuters wrote on Friday, citing people familiar with the matter.

In Postal Service news,

  • Govexec reports,
    • “The U.S. Postal Service has begun insourcing some of its trucking operations, opening the possibility of bringing back in-house thousands of jobs that are currently contracted out. 
    • “The pilot program started in Oklahoma City with 125 insourced jobs late last year and has since expanded to the larger Richmond, Virginia, area, including Charlottesville, according to officials involved in the initiative and public job postings. The Postal Service is actively looking for areas to expand the program, though it is so far relaying few details about its long-term plans to stakeholders or the public. 
    • “The Oklahoma City pilot was set to last at least six months, but is still in effect nine months later. USPS signed a memorandum of understanding with the American Postal Workers Union to create a new job series—postal vehicle operator—as part of the initiative. The Richmond expansion coincided with the Postal Service revamping its mail transportation in that metro area, as the city will host one of the agency’s first new, all-inclusive Regional Processing and Distribution Centers. 
    • “It also coincides with Postmaster General Louis DeJoy’s plan to significantly reduce the agency’s reliance on air transportation. USPS has saved $1 billion by slashing its chartered mail flights by 90% over the last two years. and it now ships 95% of its mail and packages on the ground.”

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, U.S. Healthcare–

From Washington, DC,

  • Congress remains on its August State/District workbreak this week. The Senate reconvenes on September 5, and the House reconvenes the following Tuesday, September 12.
  • The Hill adds
    • “Speaker Kevin McCarthy (R-Calif.) said on Sunday he does not want short-term stopgap funding to butt up to the holidays as lawmakers struggle to come to an agreement over appropriations levels in the midst of a push by conservatives cut federal spending.” 

From the public health front —

  • The Wall Street Journal reports
    • “Scientists obsessed with aging are sketching a road map of how our bodies change as we grow old in the hopes that it will lead to treatments that could help us live longer, healthier lives.
    • “They call this road map the “hallmarks of aging”—a set of biological features and mechanisms linked to our inexorable march toward death. Over the past decade, the hallmarks have helped guide the development of drugs that clear away cells that have stopped dividing and gene therapies that appear to restore cells to a more youthful state.
    • “Scientists in Europe codified nine hallmarks in a 2013 paper in the journal Cell that is widely cited in the aging field. They include shortening of telomeres (DNA segments at the ends of chromosomes); cell senescence, when cells stop dividing; and breakdowns in how cells regulate nutrients.
    • “The hallmarks appear to manifest with age and accelerate aging when enhanced. They are interconnected in ways researchers are trying to understand. Some believe this could unlock insights into why we age.” 
  • Becker’s Payers Issues explains how health insurers have responded to the tragic Maui wildfire.

From the FEHB front,

  • Federal News Network updates us on a fertility coverage issue that has attracted the attention of Democrat members of Congress. The FEHBlog expects that in 2024, common sense will prevail here because OPM has mandated unlimited coverage of artificial and intrauterine insemination. OPM can always clarify the situation with one of its carrier letters.

From the U.S. healthcare business front,

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.