Cybersecurity Saturday

Generative AI

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front —

  • Nextgov reports,
    • “Cybersecurity experts are warning that a potential cyber leadership vacuum in the federal government may prevent agencies from recovering and responding to a sprawling ransomware attack that has already exposed millions of Americans’ personal data.
    • “A senior official with the Cybersecurity and Infrastructure Security Agency confirmed on a call with reporters last week that several federal civilian agencies were among the victims in a widespread cyberattack that exploited a vulnerability discovered in the popular MOVEit file-transfer product developed by Progress Software. The attack is believed to have been carried out by CL0p, a Russian-linked ransomware gang otherwise known as TA505. Since the news of the global attack was first reported, a variety of federal and state agencies, banks and private sector organizations also confirmed they were victims and that data may have been stolen from millions of customers.
    • “The Office of the National Cyber Director was established under the National Defense Authorization Act for fiscal year 2021 in large part to provide coordination and guidance across the federal government on cybersecurity matters, including incident response and crisis management. Chris Inglis, the first-ever Senate-confirmed national cyber director, stepped down in February after helping to develop the new national cyber strategy released earlier this year. President Joe Biden has not yet nominated a replacement to fill the post.” 
  • Cybersecurity Dive adds,
    • “The U.S. State Department is offering a $10 million bounty related to information on the Clop ransomware gang, which is attributed to broad exploits of the MOVEit transfer vulnerabilities with victims that include federal agencies.  
    • “The Department of Energy confirmed data was impacted by an attack, and reports from CNN indicate a possible attack is being investigated against the Office of Personnel Management. The U.S. Department of Agriculture is also dealing with a third-party vendor data breach.” 
  • Cyberscoop tells us,
    • “The Department of Justice established a cyber-focused section within its National Security Division to combat the full range of digital crimes, a top department official said Tuesday.
    • “The National Security Cyber Section — NatSec Cyber, for short — has been approved by Congress and will elevate cyberthreats to “equal footing” with other major national security issues, including counterterrorism and counterintelligence, Assistant Attorney General for National Security Matt Olsen said in remarks at the Hoover Institution in Washington. 
    • “The new section enables the agency to “increase the scale and speed of disruption campaigns and prosecutions of nation-state cyberthreats as well as state-sponsored cybercriminals, associated money launderers, and other cyber-enabled threats to national security,” Olsen said. 
    • “The NatSec Cyber Center arrives at a time of growing concern about nation-state cyberattacks especially originating from Russia and China. Last week, Jen Easterly, director of the Cybersecurity and Infrastructure Security Agency, warned Americans to be prepared for a major Chinese cyberattack. “This, I think, is the real threat that we need to be prepared for, and to focus on, and to build resilience against,” she said at an event in Washington.”
  • The Cybersecurity and Infrastructure Security Agency shares a “Readout from CISA’s 2023 Second Quarter Cybersecurity Advisory Committee Meeting.”
  • The National Institutes of Standards and Technology announced on June 22, 2023,
    • “U.S. Secretary of Commerce Gina Raimondo announced that the National Institute of Standards and Technology (NIST) is launching a new public working group on artificial intelligence (AI) that will build on the success of the NIST AI Risk Management Framework to address this rapidly advancing technology. The Public Working Group on Generative AI will help address the opportunities and challenges associated with AI that can generate content, such as code, text, images, videos and music. The public working group will also help NIST develop key guidance to help organizations address the special risks associated with generative AI technologies. The announcement comes on the heels of a meeting President Biden convened earlier this week with leading AI experts and researchers in San Francisco, as part of the Biden-Harris administration’s commitment to seizing the opportunities and managing the risks posed by AI. * * *
    • “[Also on June 22], the National Artificial Intelligence Advisory Committee delivered its first report to the president and identified areas of focus for the committee for the next two years. The full report, including all of its recommendations, is available on the AI.gov website.
    • “Questions about the public working group or NIST’s other work relating to generative AI may be sent to: generativeAI@nist.gov“

From the cybersecurity vulnerabilities and breaches front —

  • Cybersecurity Dive offers details on the MoveIT file transfer program vulnerability and resulting breaches.
    • “Big names disclose MOVEit-related breaches, including PwC, EY and Genworth Financial
    • “More than 100 organizations have been hit as part of the MOVEit attack campaign, including PBI Research Services, which exposed millions of customer data files to theft.”
  • Cyberscoop informs us,
    • “Apple issued a security update on Wednesday for all its operating systems to patch dangerous vulnerabilities that could allow attackers to take over someone’s entire device. 
    • “The vulnerabilities in question first revealed on June 1, appeared to have led the main Russian intelligence agency to make unusually public claims that Apple intentionally left the flaws in its iOS so the National Security Agency and other U.S. entities could compromise “thousands” of iPhones in Russia. Apple has denied those claims.
    • “The charges from the Federal Security Service, or FSB, came the same day that researchers with cybersecurity firm Kaspersky published a report detailing what they said was an “ongoing” zero-click iMessage exploit campaign dubbed “Operation Triangulation” targeting iOS that allowed attackers to run code on phones with root privileges, among other capabilities. Kaspersky published an additional analysis Wednesday, saying that after roughly six months of collecting and analyzing the data, “we have finished analyzing the spyware implant and are ready to share the details.”
  • HHS’s healthcare sector cybersecurity coordination center (HC3) issued an analyst note on “SEO poisoning.”
    • Search engine optimization (SEO) poisoning, considered a type of malvertising (malicious advertising), is a technique used by threat actors to increase the prominence of their malicious websites, making them look more authentic to consumers. SEO poisoning tricks the human mind, which naturally assumes the top hits are the most credible, and is very effective when people fail to look closely at their search results. This can lead to credential theft, malware infections, and financial losses. As more organizations utilize search engines and healthcare continues to digitally transform, SEO poisoning is becoming a larger security threat. HC3 has observed this attack method being used recently and frequently against the U.S. Healthcare and Public Health (HPH) sector.
  • Security Week relates,
    • “The National Security Agency (NSA) has published technical mitigation guidance to help organizations harden systems against BlackLotus UEFI bootkit infections.
    • “The NSA’s recommendations provide a blueprint for defenders to protect systems from BlackLotus, a stealthy malware that emerged on underground forums in late 2022 with capabilities that include user access control (UAC) and secure boot bypass, unsigned driver loading, and prolonged persistence.”
  • This week, CISA added six and then five more known exploited vulnerabilities to its catalog.

From the ransomware front, here is the link to Bleeping Computer’s The Week in Ransomware.

From the cybersecurity defenses front —

  • Health IT Security points out,
    • “Cyber resilience is crucial to business continuity amid a cyber incident, as it ensures that systems can recover quickly. As such, it is no surprise that cyber resilience would be top-of-mind for organizations undergoing a digital transformation.  
    • “In Accenture’s new “State of Cybersecurity Resilience 2023” report, researchers exemplified the benefits of cyber resilience by identifying a group of companies that it calls “cyber transformers.”
    • “Cyber transformers, according to Accenture, “strike a balance between excelling at cyber resilience and aligning with the business strategy to achieve better business outcomes.”
  • NIST announced
    • “NIST’s IoT cybersecurity guidance has long recognized the importance of secure software development (SSDF) practices, highlighted by the NIST IR 8259 series—such as the recommendation for documentation in Action 3.d of NIST IR 8259B, that manufacturers have considered and documented their “secure software development and supply chain practices used.” The NIST SSDF (NIST SP 800-218)describes software development practices that can aid manufacturers in developing IoT products by providing guidance for the secure development of software and firmware. These development practices can also provide assurance to customers regarding how those products were developed and how the manufacturer will support them. When used together, NIST’s SSDF and IoT cybersecurity guidance help manufacturers design and deliver more secure IoT products to customer.”

Happy Juneteenth

David Ermer–Congress, Generative AI, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Photo by Derek Lamar on Unsplash

Mercer Consulting offers us this background

  • “On June 19 this year, 96 year-old Opal Lee will once again invite others to join her on a 2.5 mile Walk for Freedom in Fort Worth, Texas. Known as the “Grandmother of Juneteenth,” Opal began campaigning decades ago for a national holiday to commemorate the anniversary of the day in 1865 when news of the Emancipation Proclamation finally reached the enslaved people in Galveston, Texas. In 2016, at age 89, Opal began a symbolic walk from Fort Worth to Washington D.C. in an effort to get 100,000 people to sign a petition to create the holiday. She was transported from city to city where she would walk 2.5 miles, representing the 2.5 years it took for freedom to reach Texas. By the time she made it to Washington, she had obtained over 1.5M signatures. In June 2021, her efforts succeeded – a bill to make Juneteenth a federal holiday was passed by Congress and signed into law by President Joe Biden.  
  • “Juneteenth has long been celebrated by Black people; Opal Lee has vivid memories of celebrating Juneteenth as a child in East Texas with music, food, and games. Since the creation of the federal holiday, more employers are recognizing its importance and embracing their role in promoting Juneteenth in the workplace. In 2021, just 9% of employers had made Juneteenth a paid company holiday. That jumped to 33% in 2022 and rose again this year, to 39%.”

Mercer Consulting adds

  • “For employers, the JAMA Open Network study [on healthcare disparities] underscores the pressing need to expand provider networks to be inclusive of diverse clinicians. By improving networks, and actively working with partners to dismantle barriers and biases within healthcare, we can begin to empower employees with choice – the ability to connect with providers who better understand their unique needs, experiences, and challenges. Diverse physician networks lead to stronger doctor-patient relationships, which ultimately lead to better health outcomes for marginalized populations.”

From Washington, DC —

  • The U.S. Supreme Court handed down five opinions last week. NPR identifies the remaining cases that it is tracking. (One of them the Indian Child Welfare Act was decided last week in favor of the Indian tribes.)
  • Last week, OMB’s Office of Information and Regulatory Affairs posted its Spring 2023 federal regulatory agenda. Here is a link to the OPM agenda. OPM is planning a second Postal Service Health Benefits Program rule and a rule that would accelerate the effective date of FEHB coverage for new federal employees.

Healthcare Dive reports

  • “The group that advises Congress on Medicare policy released a new report Thursday [June 15] with recommendations on telehealth, overpayments to Medicare Advantage plans and site-neutral payments across some outpatient care settings.
  • “The Medicare Payment Advisory Commission, or MedPAC, included telehealth in the report to satisfy a mandate from Congress after virtual care surged during the COVID-19 pandemic. Telehealth coverage under Medicare was limited before the public health emergency, and it was expanded to preserve access to care.
  • “The report found fee-for-service Medicare spending for telehealth care was $4.8 billion in 2020 and $4.1 billion in 2021, more than 30 times greater than 2019. Early findings show more telehealth use was associated with little change in quality, slightly improved access to care for some beneficiaries and slightly increased costs to Medicare.”

From the MD opinion front —

  • An emergency room doctor writing in MedPage Today gives us his take on the fentanyl crisis.
  • An oncologist writing in STAT News gives us her take on the cancer drug shortage. Her article’s title says it all: “Cancer drug shortages should have patients rioting in the streets.”

From the generative AI front, Healthcare IT News tells us, “An NYU Langone Health [large language model] LLM can predict hospital readmissions. The large language model is still in testing, but the AI tool had a median accuracy score of 77.8% compared to a physician score of 62.8%. The code base is now available to all healthcare organizations [via GitHub].

From the semaglutide drug front —

  • The Wall Street Journal reports that these drugs designed for weight loss also may bring alcohol and tobacco use from an addiction to a controllable level.
  • Politico discusses manufacturer lobbying efforts to convince Congress to cover these drugs for weight loss unconnected to diabetes.
  • Bloomberg informs us
    • “Some dosages of Eli Lilly & Co.’s Mounjaro are again in shortage, the latest in a line of recurring supply issues caused by patients using the diabetes medication as a weight-loss treatment.
    • “The latest shortage will result in “intermittent backorders” for three of six doses through July, according to an update posted by the US Food and Drug Administration on its website on Friday.
    • “Lilly spokesperson Jessica Thompson said the backorders were “due to continued dynamic patient demand” and would affect the three highest doses of Mounjaro. She also said the company is investing in expanding manufacturing capacity.”

From the miscellany front –

  • CNBC reports
    • “Bristol Myers Squibb on Friday sued the Biden administration over Medicare’s new powers to slash drug prices, the third such lawsuit to be filed against the program in a matter of days.
    • “The lawsuit filed in federal district court in New Jersey argues the Medicare negotiations violate the First and Fifth Amendments of the U.S. Constitution.
    • “Bristol Myers Squibb has asked the court to declare the program unconstitutional and prevent the Health and Human Services Department from forcing the company to enter negotiations.
    • “Bristol Myers Squibb’s arguments mirror those lodged last week by Merck, the first company to sue the federal government over the drug negotiations. The U.S. Chamber of Commerce has also sued HHS over the program with similar arguments.”
  • Fierce Healthcare relates
    • “Simple HealthKit has inked a deal with Walmart to bring at-home diagnostic tests, including diabetes, respiratory wellness and sexual wellness labs, to the largest retailer in the world.
    • “Through the retail giant’s website, customers can purchase tests bolstered by Simple HealthKit’s end-to-end healthcare infrastructure, including testing, follow-up and treatment. The digital health company’s HbA1c test identifies key markers for Type 2 diabetes. Respiratory wellness tests include influenza A, influenza B and respiratory syncytial virus. In light of a decrease in sexual health testing during the pandemic, customers can test for three of the most common STDs at home, chlamydia, gonorrhea and trichomoniasis.”
  • Health Payer Intelligence points out
    • Employer-sponsored health plan enrollment among nonelderly Americans will grow after 2025, accompanied by higher private payer premiums, a Health Affairs study found.
    • The study used Congressional Budget Office projections to estimate future coverage trends. However, the researchers noted many uncertainties embedded in these trends, including future economic, policy, and healthcare utilization changes. * * *
    • After 2025, enhanced subsidies will end and employment will increase, driving more people to employer-sponsored coverage. Approximately 157 million individuals may have employer-sponsored coverage in 2027. By 2033 this population will grow to 159 million.
    • Private-payer premiums will also trend upward from 2023 through 2033. In 2023, the private payer premium growth rate will be 6.5 percent. Premiums will grow 5.9 percent from 2024 to 2025 and 5.7 percent from 2026 to 2027. By 2033, the average premium increase will be 4.6 percent.
  • Of course, depending on the outcome of the 2024 federal election, it is possible that the ACA subsidies could be made permanent in 2025. Time will tell.

Friday Factoids

David Ermer–CMS, FDA, Federal employment benefits, Generative AI, Medicare, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the FDA front —

  • MedPage Today tells us
    • “Lecanemab (Leqembi) showed clinical benefit in early Alzheimer’s disease in its confirmatory trial, paving the way for traditional approval of the drug, an FDA advisory committee said Friday.
    • “In a 6-0 vote, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee fully backed the evidence supporting the anti-amyloid monoclonal antibody. * * *
    • “The agency is expected to make its final decision about lecanemab by July 6.
  • KFF provides a cost perspective in anticipation of FDA approval of this drug, which action is expected to trigger CMS approval for Medicare Part B coverage.

From the FEHB front, Tammy Flanagan writing in Govexec delves into FEHB and Medicare Part B coverage.

From the litigation front —

  • The Wall Street Journal reports
    • “Pharmaceutical industry giants completed a deal to pay $19 billion to states that accused them of fueling the opioid crisis, infusing more money into communities still struggling with how to address the scourge of drug use.”
    • “Most states agreed to the deal to settle agreements with manufacturers Teva and Allergan as well as pharmacy chains CVS and Walgreens. The agreement is in addition to a $26 billion so-called global settlement with drug distributors McKesson, Cardinal Health and AmerisourceBergen and manufacturer Johnson & Johnson. The latest settlements close lawsuits against most of the major players and brings the total income from opioid litigation that states will have to spend to about $50 billion. 
    • “The legal fight stretches back nearly a decade, when more than 3,000 lawsuits from states, Native American tribes and counties alleged the drugmakers, pharmacies and distributors played down the risk of painkillers and didn’t stem their flow. Misuse of prescription painkillers sparked a health crisis that was supercharged as fentanyl infiltrated the illicit drug supply and now claims more than 100,000 lives in the U.S. each year. 
    • “Money from the recent settlements will begin to flow to states this year. More than $3 billion from the global settlementhas already been dispersed. The funds are distributed to states based on population adjusted to account for the burden of the opioid epidemic based on deaths and people using drugs. The agreements require most of the money to be spent on abating the opioid crisis, but the parameters are broad and officials are using different strategies to spend it.”
  • KFF has created a tracker to follow the distribution of the opioid litigation settlement funds.

From the CMS front —

  • Healthcare Dive informs us,
    • “CMS is exploring programs that would pay social or community health workers to address patients’ social needs in a bid to invest more heavily in food, housing, transportation and other social determinants of health, according to agency officials.
    • “We are looking at that. For example, in maternal health, thinking about the role of doula and community health workers,” Liz Fowler, director of the Center for Medicare and Medicaid Innovation, said on Thursday during the CMS’ inaugural health equity conference.”
  • and
    • “CMS announced a new model that aims to strengthen and improve primary care, including by ensuring small and rural organizations are able to enter into value-based care arrangements. 
    • “The Making Care Primary Model will run for more than 10 years in eight states — in Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington.
    • “Research shows primary care is key to improving health outcomes and lowering costs. The CMS noted Medicare and Medicaid patients are often diagnosed with multiple chronic conditions, and primary care providers are charged with prevention, screening and management. But, because many patients will see multiple specialists, coordinating care can be challenging.”
  • Fierce Healthcare relates,
    • “The Department of Health and Human Services (HHS) has released a 43-drug list of the Medicare Part B prescription treatments that must repay the program for raising prices above the rate of inflation.
    • “The second quarterly list takes effect in July and is an expansion over the 20 price-capped drugs from April through June. According to HHS, the rebates could save Medicare beneficiaries taking the treatments anywhere from $1 to $449 per average dose in out-of-pocket costs.
    • “The Medicare Prescription Drug Inflation Rebate Program is a critical way to address long-term price increases by drug companies, and [the Centers for Medicare and Medicaid Services (CMS)] is continuing our work to make prescription drugs more affordable for people with Medicare,” CMS Administrator Chiquita Brooks-LaSure said in a release.
    • “The full list of prescription drugs and biological products with adjusted coinsurance amounts for July 1 to Sept. 30 is available here (PDF).
    • “Of note, CMS said the list could be adjusted before or after July 1 based on public feedback notifying the agency of any potential discrepancies, as was the case during the program’s inaugural quarter when a highly publicized list of 27 drugs was later trimmed down to 20.”

From the U.S. healthcare business front —

  • Beckers Hospital Review reports
    • “In the first quarter of 2023, 17 healthcare companies with more than $10 million in liabilities filed for Chapter 11 bankruptcy, a sharp rise compared to seven bankruptcies in the first quarter of 2022, Bloomberg Law reported June 9.
    • “High-profile bankruptcies from Envision, Invacare Corp. and Sorrento Therapeutics contributed to the numbers. The first three months of 2023 saw a slight slump in bankruptcies but remain higher than the same period a year ago.
    • “Despite the year-over-year increase, the first quarter of 2023 still had fewer healthcare bankruptcies than the fourth quarter of 2022.
    • “Once the government money ran out, once all the stimulus dollars around healthcare ran out, there was essentially going to be this backwash,” Timothy Dragelin, a healthcare director at FTI Consulting, told Bloomberg. “The fact that labor costs increased substantially—you also had the issues with supply chain and supply chain caused some disruptions.”
  • Fierce Healthcare tells us
    • “Walgreens Boots Alliance sold its remaining stake in post-acute care and infusion services company Option Care Health for $330 million.
    • “The drugstore chain announced Thursday it sold 10.8 million shares of Option Care Health and plans to use the proceeds primarily for debt paydown, continued support of the company’s strategic priorities and to help fund its healthcare-focused business initiatives, according to a press release.
    • “The transaction is another decisive action WBA is taking to unlock value and further simplify the company’s portfolio,” the company said.
    • “Back in March, Walgreens cut its stake in Option Care Health when it sold 15.5 million shares at $30.75 per share. The transaction reduced Walgreen’s ownership in the company, formerly known as Walgreens Infusion Services, from 14% to 6%, according to a Walgreens news release. “

From the generative AI front —

  • Beckers Hospital CFO Report points out the steps the Google and Microsoft are taking to integrate generative AI in healthcare systems.
  • HR Dive discusses the impact of generative AI on employers and the workplace.

Midweek update

David Ermer–Generative AI, Medical / Rx research, Mental health care, Patient safety, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC —

  • STAT News tells us,
    • “Ahead of a major Food and Drug Administration meeting on a new Alzheimer’s treatment this week, several Democratic lawmakers are ratcheting up their criticism of how the Biden administration is planning to handle a potential approval this summer.
    • “Sen. Bernie Sanders (I-Vt.), who leads the Senate’s health committee, wrote to health secretary Xavier Becerra on Wednesday asking him to ”use the full extent” of his authority to ensure Medicare doesn’t pay the list price of $26,500 for Eisai and Biogen’s Leqembi.”

From the U.S. healthcare business front —

  • Healthcare Dive informs us,
    • “The financial performance of the seven largest publicly traded U.S.-based insurers remains stable so far this year, despite “continued challenges” in the healthcare sector, according to a report out Tuesday from credit ratings agency Fitch Ratings.
    • “Though persistent staffing shortages and high inflation has been pressuring healthcare providers, the largest payers, which Fitch estimates to account for about 70% of the privately ensured U.S. population, reported a 7.7% operating EBITDA margin in the first quarter compared with 7.6% during the same period in 2022.
    • “However, the report noted that cost pressures at the provider level could impact payer and provider contract negotiations and cause premium rates to increase over the next few years, contributing to “heightened public discourse around healthcare costs for consumers.”
  • Per the Lown Institute —
    • A recent New York Times investigation found that Allina Health System, a nonprofit health system in the Midwest, has been rejecting patients for appointments if they have unpaid medical bills. If patients amass at least $1,500 in medical debt three separate times, they may not be allowed to come back to a clinic or hospital until they pay up. In many cases, Allina’s electronic health record system precludes doctors from making new appointments with patients that have unpaid debt.
    • The policy, which was started in 2006, applies to patients struggling with chronic conditions like diabetes and depression, and is even applied to children. The Times heard from doctors and patients who described being unable to complete medical forms that children needed to enroll in day care or show proof of vaccination for school. Allina’s dominance in the region also means that patients who are rejected for care–especially patients in rural areas–may have trouble finding other providers. 
    • How is a nonprofit system allowed to deny needed care for patients with debt? While nonprofit hospitals are required by federal law to accept any patient for emergency care regardless of ability to pay, the same requirement doesn’t apply to non-emergency care. 
    • Because there aren’t regulations against this practice, Allina is not alone in rejecting patients with debt. According to a 2022 KFF Health News investigation of 528 hospitals sampled nationwide, 55 indicated in their written policy that they do allow deniels of non-emergency care for patients with medical debt, 22 said this is allowed but not current practice, and 85 others had no information in their policy on whether or not they do this. (Allina Health Faribault Medical Center was included in this last group, but no other Allina hospitals were included in the study). Among the hospitals that allow for care denials are within some of the largest nonprofit systems in the country, including Ascension, Indiana University Health, Cedars-Sinai Medical Center, Mayo Clinic, Trinity Health, and more.

From the healthcare research front, BioPharma Dive offers its wrap-up report on the ASCO conference held in Chicago this week.

From the SDOH front —

  • Healthcare Dive points out,
  • “Patients of color, or those on public insurance, are still at increased risk for certain adverse events compared to White patients, regardless of high hospital safety ratings, according to a report out Wednesday from the Leapfrog Group.
  • “Although higher hospital safety ratings generally correspond with fewer adverse safety events, the report found that pattern doesn’t hold true for patients of color or those on Medicare or Medicaid, who were more likely to experience adverse events after surgery, including sepsis, blood clots and respiratory failure.
  • “Rather than suggesting problems with individual hospitals, the data points to a “systemic issue impacting the quality of care for Black and Hispanic patients and those with public insurance plans,” according to the report.”

From the mental healthcare front, Health Payer Intelligence discusses six strategies that payers can use to promote behavioral health prevention, along with a strong provider network.

From the litigation front —

  • Fierce Healthcare reports
    • “A federal appeals court held a brief hearing Tuesday afternoon to hear from attorneys on both sides as it decides whether to lift a nationwide freeze on a lower court’s ruling that struck down preventive care protections in the Affordable Care Act (ACA).
    • “A panel of judges at the Fifth Circuit Court of Appeals, based in New Orleans, issued a stay on the District Court ruling while the appeals process plays out, though it could choose to lift the stay following Tuesday’s hearing. Legal experts expect a decision on the pause in short order.”
  • The FEHBlog is willing to bet the ranch that the panel will uphold the existing stay.

From the generative AI front —

  • Healthcare Dive relates
    • “Google is linking up with longtime collaborator Mayo Clinic to explore generative artificial intelligence’s applications in the hospital, the tech giant announced Wednesday morning.
    • “Mayo will use a Google Cloud tool that lets organizations create chatbots and search applications using generative AI to answer complex questions and produce summaries faster than traditional search functionalities.
    • “Mayo could improve the efficiency of clinical workflows and make it easier for clinicians and researchers to find information, Google said.”

In federal employee benefits news, Federal News Network tells us

  • “The Office of Personnel Management’s backlog of retirement claims dropped by 2,259 in May. OPM received 6,096 claims, just over 2,200 fewer than in April, which saw 8,298. OPM processed 8,355 claims, bringing down the inventory backlog to 18,125, the lowest it has been since June 2020, when it reached 17,432.
  • “OPM still has improvements to make, as the inventory backlog is more than 5,000 claims above the steady state goal of 13,000.”

Midweek update

David Ermer–Congress, Electronic health records, End of the PHE, NE, Generative AI, Medical / Rx research–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “Negotiators worked Wednesday to reach an agreement on reining in government spending, which has emerged as the central hurdle to a deal to raise the debt ceiling, with a possible government default just a week away.
    • “U.S. stocks extended declines Wednesday, reflecting rising anxieties about the debt ceiling, with the Dow Jones Industrial Average posting a fourth-straight session of losses.
    • “The White House has offered a spending freeze for next year, while GOP negotiators have insisted that any deal must result in lower discretionary spending, calling it a critical step in starting to address the country’s growing debt, which now stands at $31.4 trillion.”

Healthcare Dive, MedPage Today, and Fierce Healthcare discuss a House Oversight and Accountability Committee hearing on prescription benefit managers held yesterday.

The House Energy and Commerce Committee cleared a bunch of healthcare-related bills for floor consideration today.

STAT News tells us, “Matt Eyles, CEO of America’s Health Insurance Plans, is leaving by this October, the lobbying group said Wednesday.” Good luck, Mr. Eyles.

From the public health front —

  • Helen Branswell, writing in STAT News, points out
    • :An impressive number of vaccines and monoclonal antibody products are racing toward the end of the development pipeline, with two products aimed at protecting children expected to receive approval from the Food and Drug Administration by autumn. One, a maternal vaccine developed by Pfizer, received a recommendation last week from FDA’s vaccine advisory committee.
    • “But there are sizable hurdles standing in the way of the implementation of these products, hurdles that could see the promise they offer squandered because of bureaucracy, health systems that don’t interact with one another, and steep price tags.”
  • Ms. Branswell discusses the hurdles with experts on the matter.
  • Forbes reports
    • This week, Achieve Life Sciences announced that its drug, cytisinicline, saw strong results in its latest phase III trial. While the drug has been used for decades in eastern Europe, it’s not yet been approved by the FDA. The drug works by targeting the nicotine receptors in the brain, CEO John Bencich tells Forbes. “It works to reduce the satisfaction you get while smoking, but also helps with the cravings and withdrawal symptoms.” 
    • The study, which followed 792 patients, had patients take the drug for either 6 weeks or 12 weeks. Both patients who received the drug and those who got a placebo also went through a behavioral program about quitting smoking. The company says that over 30% of those who took the drug for 12 weeks stopped smoking completely in the last four weeks of the study, compared to less than 10% in the placebo group. For six weeks of treatment, the drug had a nearly 15% success rate compared to 6% in the placebo group. The company saw similar success in a smaller study it reported in the spring on the success of the drug in helping patients quit vaping. Patients will be monitored for 24 weeks after completing the cessation program, and the company expects to file a new drug application with the FDA in the first half of 2024. 
  • This week’s Econtalk podcast offers an interview between host Russ Roberts and University of Chicago economist Casey Mulligan about the macroeconomic angles of public health issues, like the Covid pandemic. Check it out.

From the interoperability front,

  • Fierce Healthcare relates
    • The total number of Epic customers pledging to join the electronic medical record provider in its participation in the Trusted Exchange Framework and the Common Agreement (TEFCA) has jumped to 27. 
    • After announcing the participation of 20 health systems plus health tech company KeyCare and health information exchange OCHIN on Monday, five more organizations have joined the pledge including Kaiser Permanente.
    • According to Matt Doyle, interoperability software development lead at Epic, the EMR company is optimistic that nearly all of the 2,000 hospitals and 600,000 clinicians that use Epic across the country will participate. 
  • Let’s go.

From the generative AI front,

  • Patient Engagement HIT tells us
    • Can ChatGPT really replace doctors? Probably not, at least for right now, as surveying shows that patient trust in chatbots and generative AI in healthcare is relatively low.
    • The report from The University of Arizona Health Sciences showed that around half of patients don’t fully trust AI-powered medical advice, like the information issued from chatbots like ChatGPT. Instead, patients still trust and prefer their traditional healthcare providers.
    • However, patients may be more receptive to chatbot medical advice if the AI is guided by a doctor’s or human’s touch.

Tuesday’s Tidbits

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, NIH, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC, the Wall Street Journal explains,

“President Biden and Democratic leaders in Congress approached this year’s debt-ceiling drama with a consistent mantra: They would absolutely never, ever, under any circumstances, negotiate over raising the country’s borrowing level.

“But now they are very much negotiating on the debt limit, just about a week before the June 1 date when the Treasury Department estimates the U.S. could run out of measures to avoid default. Talks are underway about how to find a package of spending cuts and other measures acceptable to enough Republicans and Democrats to clear Congress, with House Speaker Kevin McCarthy (R., Calif.) and Biden meeting Monday and planning further talks to craft a deal framework in coming days.

“We’re not there yet” on a deal, said McCarthy on Tuesday. White House press secretary Karine Jean-Pierre said: “While areas of disagreement remain, the president, the speaker and their teams will continue to discuss the path forward.”

Govexec adds,

“Most non-defense federal agencies appear headed for at least a spending freeze next fiscal year—if not an outright cut—as President Biden has offered to back down from his proposed spending increases in exchange for an increase to the government’s debt ceiling. 

House Republicans, who are spearheading negotiations with the White House to avoid a debt default that could occur as soon as June 1, have rejected that proposal, holding out for cuts compared to current spending levels. The two sides have been locked in marathon negotiations for the last week, agreeing to some costccc-cutting measures but remaining far from an overall agreement.”

 From the public health front —

  • Roll Call reports,
    • New HIV infections dropped 12 percent in 2021 compared to 2017, according to new Centers for Disease Control and Prevention estimates released Tuesday, with the biggest drops among young gay and bisexual men.
    • But the agency warned that HIV prevention efforts need to be accelerated to reach the national goals.
    • The data Tuesday credited the overall decrease to a 34 percent drop in infections among 13-24 year olds, with the largest declines among young gay and bisexual men. Annual HIV infections among young people decreased from 9,300 to 6,100, but among young LGBTQ men new infections dropped from 7,400 to 4,900.
  • McKinsey Health Institute released a survey shedding “light on the health perceptions and priorities of people aged 55 and older.”
    • “Among the results, unsurprisingly, is that older adults who have financial stability—no matter their country—are more likely than their peers to be able to adhere to healthy habits, including those that boost cognitive health.3 And contrary to the perception that older adults are tech laggards compared with their younger peers, the results find widespread technology adoption, especially in smartphone use, among the older adult population.”
  • The U.S. Preventive Services Task Force issued draft recommendations and evidence reviews for the following projects: Oral Health in Adults: Screening and Preventive Interventions and Oral Health in Children and Adolescents Ages 5 to 17 Years: Screening and Preventive Interventions. Both recommendations are “I” for inconclusive. The public comment submission deadline is June 30, 2023.
  • The U.S. Surgeon General Dr. Vivel Murthy circulated “a new Surgeon General’s Advisory on Social Media and Youth Mental Health – PDF. While social media may offer some benefits, there are ample indicators that social media can also pose a risk of harm to the mental health and well-being of children and adolescents. Social media use by young people is nearly universal, with up to 95% of young people ages 13-17 reporting using a social media platform and more than a third saying they use social media “almost constantly.”

From the medical research front —

  • The New York Times reports, “Researchers have for the first time recorded the brain’s firing patterns while a person is feeling chronic pain, paving the way for implanted devices to one day predict pain signals or even short-circuit them.”
  • The NIH Director’s Blog tells us, “Basic Researchers Discover Possible Target for Treating Brain Cancer.”

From the Rx coverage front —

  • The Drug Channels blog points out “The Top Pharmacy Benefit Managers of 2022: Market Share and Trends for the Biggest Companies.”
    • “We estimate that for 2022, about 80% of all equivalent prescription claims were processed by three companies: the Caremark business of CVS Health, the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group. 
    • “This concentration reflects the significant transactions and business relationships among the largest PBMs that have further concentrated market share. Five of the six largest PBMs are now jointly owned by organizations that also own a health insurer, as illustrated in Mapping the Vertical Integration of Insurers, PBMs, Specialty Pharmacies, and Providers: A May 2023 Update. 
      • “The big three PBMs’ aggregate share of claims was similar to the 2021 figure. Compared with 2021, however, Cigna’s share declined due to customer losses, while OptumRx’s share grew slightly. Two other notable market changes affected the 2022 figures:
      • “In January 2022, Caremark added the specialty business back to its Federal Employee Program (FEP) mail and clinical pharmacy services contract. The specialty portion of the FEP had transitioned to Prime Therapeutics in 2018. 
      • “In late 2022, Prime Therapeutics completed its acquisition of Magellan Rx from Centene. For 2022, Magellan Rx managed $22.9 billion in drug spend and had annual claims volume of 220.9 million. Magellan Rx annualized claims are included with Prime’s figures above.
    • “Beginning in 2024, Express Scripts will begin a five-year agreement to manage pharmacy benefits for more than 20 million Centene beneficiaries. We estimate that the Centene business will bring $35 to $40 billion in total gross pharmacy spend and more than 550 million prescriptions. This forthcoming shift of Centene’s PBM business from CVS Health’s Caremark to Cigna’s Express Scripts will significantly alter the relative position of these companies. 
  • MedPage Today informs us,
    • “The first nalmefene hydrochloride nasal spray (Opvee) won FDA approval for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and up, the agency announced.
    • “If administered quickly, the opioid receptor antagonist provides fast onset and long duration reversal of opioid-induced respiratory depression. It will be available for use by prescription in healthcare and community settings.”
  • The FDA announced
    • “approving Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. 
    • “According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines.”

From the generative artificial intelligence front, STAT News provides expert perspectives and answers readers’ common questions about AI and healthcare.

From the U.S. healthcare business front —

  • Healthcare Dive relates,
    • “The newly rebranded Intermountain Health reported $549 million in net income for the first three months of 2023, an increase from the prior-year period when the health system posted a $298 million net loss. 
    • “The Salt Lake City-based system brought in $4 billion in revenue compared with $2.8 billion in the period ended March 31 last year. 
    • “Intermountain’s expenses still climbed 44% to $3.7 billion, with a large portion coming from employee compensation and benefits at $1.7 billion. But supply costs grew too, reaching $703 million during the quarter, an increase of 46% from a year earlier.”
  • Fierce Healthcare notes,
    • “Cleveland Clinic is starting 2023 on the right side of zero, reporting Tuesday a Q1 operating income of $32.3 million (0.9% operating margin) and a net income of $335.5 million.
    • “Though the nonprofit system had reported a $1.2 billion net loss across 2022, the first quarter’s numbers continue the upward momentum Cleveland Clinic enjoyed at the end of last year.
    • “Like many health systems have reported in recent weeks, the performance is also a substantial bounce back from Q1 2022when the omicron wave dragged Cleveland Clinic to a $104.5 million operating loss (-3.4% operating margin) and a $282.5 million net loss.
    • “On a year-over-year basis, total unrestricted revenues grew 15.7% by way of a 13.3% rise in net patient revenue, to $3.1 billion, and a 37.3% increase in other restricted revenues, to $425.3 million.”