FEHBlog

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity breaches and vulnerabilities front —

  • Cybersecurity Dive tells us,
    • “Distributed denial of service attacks surged during the second quarter as criminal and state-linked hacking organizations unleashed a number of sophisticated attacks against critical infrastructure providers and other organizations across the globe, Cloudflare said in a report released Tuesday.  
    • “Experts linked pro-Russia hacktivist groups, including Killnet and Anonymous Sudan, to recent major DDoS attacks against Microsoft and threats against financial centers in the U.S. and Europe. 
    • “Cloudflare research shows a sharp increase in deliberately engineered and targeted DNS attacks.”
  • Health IT Security adds,
    • “Healthcare organizations face an uptick in cyber threats as malicious actors turn to tools like ransomware, artificial intelligence (AI), and Internet of Things (IoT) attacks. These threats are becoming increasingly significant in the dynamic cyber threat landscape, a Trustwave SpiderLabs report revealed.
    • “The report “Cybersecurity in the Healthcare Industry: Actionable Intelligence for an Active Threat Landscape” provides insights and practical strategies to address the specific threats faced by healthcare organizations.”
  • Security Week informed us on July 21, 2023,
    • “Researchers at cloud security startup Wiz have an urgent warning for organizations running Microsoft’s M365 platform: That stolen Microsoft Azure AD enterprise signing key gave Chinese hackers access to data beyond Exchange Online and Outlook.com.
    • “Our researchers concluded that the compromised MSA key could have allowed the threat actor to forge access tokens for multiple types of Azure Active Directory applications, including every application that supports personal account authentication, such as SharePoint, Teams, and OneDrive,” Wiz researcher Shir Tamari said in a document posted online.
    • “Tamari said the hackers may have also accessed Microsoft customer applications that support the “login with Microsoft” functionality and multi-tenant applications in certain conditions.”
  • Also per Security Week on July 18, 2023, “At least two new Adobe ColdFusion vulnerabilities have been exploited in the wild, including one that the software giant has not completely patched.”

From the ransomware front —

  • Cyberscoop interviews an FBI official about how the agency fights ransomware.
  • The FEHBlog welcomes back Bleeping Computer’s Week in Ransomware after two weeks away. This week’s article covers news from July 8 forward.

From the cybersecurity defenses front —

  • CISA explains how to take the first steps toward better cybersecurity.
  • What’s more, CISA “has developed and published a factsheet, Free Tools for Cloud Environments, to help businesses transition into a cloud environment and identify proper tools and techniques necessary for the protection of critical assets and data security. Free Tools for Cloud Environments provides network defenders and incident response/analysts open-source tools, methods, and guidance for identifying, mitigating, and detecting cyber threats, known vulnerabilities, and anomalies while operating a cloud or hybrid environment.” 
  • HHS’s Health Sector Cybersecurity Coordination Center (HC3) on July 18, 2023, informed us about patches available for Critical and High Netscaler ADC (Citrix ADC) and Netscaler Gateway (Citrix Gateway) vulnerabilities.
  • HC3 also issued an analyst note on July 21, 2023, about Remote Identity Management.
    • “Identity theft is not limited to stolen medical records, social security numbers, and financial data. Threat actors can also target institutions by capitalizing on gaps in user access protocols, hiring processes, and mitigation capabilities to conceal some aspect of their identity and attention. Identity verification, fraud detection and user authentication are imperative when implementing a robust Identity and Access Management (IAM) program.”
  • Security Week looks into improving security awareness training for employees.
  • ISACA explains how to build cybersecurity resilience throughout an organization.

Friday Factoids

David Ermer–Generative AI, HIPAA Privacy and Security Rules, HSA, OPM, Patient safety, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us, “The Office of Personnel Management on Friday proposed new regulations aimed at granting federal agencies greater flexibility in selecting new federal employees during the hiring process.” The public comment deadline is September 19, 2023.
  • Federal News Network offers a table of federal government return-to-office policies.
  • The Society for Human Resource Management informs us,
    • “The U.S. Citizenship and Immigration Services (USCIS) announced Friday a new Form I-9—which has been streamlined and shortened—that employers should use beginning Aug. 1, 2023.
    • “Employers may continue to use the older Form I-9 (Rev. 10/21/19)  through Oct. 31., 2023. After that date, they will be subject to penalties if they use the older form. The new version will not be available for downloading until Aug. 1.  
    • “Additionally, the U.S. Department of Homeland Security (DHS) issued a final rule that allows the agency to create a framework under which employers could implement alternative document examination procedures, such as remote document examination. The new form subsequently has a checkbox to indicate when an employee’s Form I-9 documentation was examined using a DHS-authorized alternative procedure.
    • “At this time, the final rule only allows employers using E-Verify to use alternative verification methods.”
  • Healthcare Dive notes
    • “The Federal Trade Commission and the HHS’ Office for Civil Rights are warning hospitals and telehealth companies about embedding online tracking technologies on their websites or apps, saying the trackers risk exposing consumers’ personal health data to third parties. 
    • “The trackers, like the Meta Pixel or Google Analytics, collect identifiable information about users and could reveal information about health conditions, diagnoses, treatments, frequency of visits and more, the agencies wrote in a letter to about 130 health systems and telehealth providers.
    • “The warning marks the latest move from regulators regarding the healthcare industry’s use of tracking technologies, which monitor user behavior on websites. Sharing consumers’ health data with third parties, like advertisers, has been a recent target of FTC oversight.”

Following up on the tornado that struck a Pfizer factory in Rocky Mount, NC, STAT News reports

  • “Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does not appear to have caused “any major damage” to areas that produce medicines.
  • “The company reported most damage from the storm occurred at a warehouse that stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance personnel. As a result, it remains unclear about the extent to which destruction at the facility — which produces nearly 8% of all sterile injectables used in U.S. hospitals — will exacerbate a growing shortage of prescription drugs across the country.”

The Food and Drug Administration also issued a report on the incident.

From the medical malpractice front, STAT News points out

  • “A new study published this week in BMJ, * * * estimates that “371,000 people die every year following a misdiagnosis, and 424,000 are permanently disabled — a total of 800,000 people suffering “serious harm,” said David Newman-Toker, the lead author of the paper and a professor of neurology at Johns Hopkins School of Medicine and director of its Center for Diagnostic Excellence. Settling on an exact number is hard because many cases of misdiagnosis go undetected, he said. It could be fewer than his study identified or more — between half a million and a million — though in any event, it would be the most common cause of death or disability due to medical malpractice. 
  • “He likens the issue of misdiagnosis to an iceberg, saying cases leading to death and disability are but a small fraction of the problem. “We focused here on the serious harms, but the number of diagnostic errors that happen out there in the U.S. each year is probably somewhere on the order of magnitude of 50 to 100 million,” he said. “If you actually look, you see it’s happening all the time.” 
  • “But misdiagnoses typically don’t lead to severe consequences because, most times, people aren’t visiting the doctor with a serious condition. “The risk level just walking through the door in the doctor’s office that something horrible is going to happen to you because of a diagnostic error is actually quite low,” said Newman-Toker.”

In related news “[The American Hospital Association] AHA today released its quarterly Health Care Plan Accountability Update, featuring the latest news on AHA efforts to hold commercial health insurers accountable for policies that can delay care for patients, burden health care providers and add unnecessary costs to the health care system. READ MORE.”

From the factoid front —

  • HealthEquity suggests three ways to drive health savings account plan adoption.
  • Beckers Payer Issues points out how seven payers are using artificial intelligence.
  • MedTech Dive reports, “Intuitive Surgical posted strong robotic volume growth in the second quarter and raised its full-year procedure outlook but said patient interest in new weight-loss drugs is curbing demand for bariatric surgeries.”

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Electronic health records, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • Govexec informs us
    • “The Senate continues to advance spending bills without controversy and with bipartisan support, offering hope that lawmakers will avoid a lapse in appropriations this fall. 
    • “The [Senate Appropriations Committee] has now approved eight of the 12 annual must-pass spending measures, most of which have won unanimous approval. Sen. Patty Murray, D-Wash., who chairs the appropriations committee, announced Thursday her panel would hold votes on the final four funding packages next week. Murray said ahead of Thursday’s votes that she was focusing on passing bills “that can actually be signed into law.”  * * *
    • “The House Appropriations Committee has approved 10 of the 12 spending bills, all largely along party-line votes. House Speaker Kevin McCarthy, R-Calif., said on Wednesday he planned to bring those to the House floor soon, adding his intention was to have the process complete before current funding expires on Sept. 30. Without commenting on the vast differences between the two sets of bills, McCarthy called it “a positive” that the Senate was already moving its spending measures.”
  • The Affordable Care Act regulators issued a letter encouraging employers and other plan sponsors to extend the special employer-sponsored health plan enrollment period for employees who lost Medicaid or CHIP coverage for themselves or family members beyond the sixty days required by law.  
  • The Department of Health and Human Services released guidance “to clarify the prohibition at 45 CFR § 162.412(b) that a health plan may not require a healthcare provider that has been assigned an NPI to obtain an additional NPI.” However, “it does not prohibit a health plan from requiring that a subpart that does not have a unique NPI obtain a unique NPI as a condition of enrollment with the health plan.”
  • The American Academy of Actuaries posted its annual report outlining the factors likely to drive premium changes in the individual and small group insurance markets for the next plan year, in this case, 2024. 

From the public health front —

  • MedPage Today informs us,
    • “A second booster with an mRNA bivalent vaccine offered the best protection against severe COVID-19 due to the Omicron BA.5 variant in older adults, and protection appeared to wane less than with the monovalent shot, a large retrospective study out of Italy showed.”
  • The National Institutes of Health announced
    • “Omega-3 fatty acids, which are abundant in fish and fish oil supplements, appear promising for maintaining lung health, according to new evidence from a large, multi-faceted study in healthy adults supported by the National Institutes of Health. The study provides the strongest evidence to date of this association and underscores the importance of including omega-3 fatty acids in the diet, especially given that many Americans do not meet current guidelines. Funded largely by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, the study results were published in the American Journal of Respiratory and Critical Care Medicine.” 
  • Cigna Healthcare offers five tips for healthier sleep.

From the EHR interoperability front, check out this fascinating Computer World update

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • More than three years after the onset of the COVID-19 pandemic, only 1% of primary care clinicians surveyed by the Larry A. Green Center and the Primary Care Collaborative believe their practice has fully recovered from its impacts, and 61% characterize U.S. primary care as “crumbling.”
    • “Nearly 80% of respondents felt the current workforce is undersized to meet patient needs, and just 19% of clinicians report their practices are fully staffed.
    • “The results are emblematic of a “larger national crisis,” and policymakers must act to reinforce primary care, said Rebecca Etz, co-director of the Larry A. Green Center, in a statement. “ … It is not a matter of if, but when there will be another pandemic … If we don’t act soon, primary care won’t be there when it happens.
  • Beckers Hospital Review tells us,
    • “Severe winds from an EF-3 tornado on July 19 crushed a North Carolina Pfizer manufacturing plant that made nearly 25 percent of the drugmaker’s sterile injectables used by U.S. hospitals. 
    • “The facility manufactured and stored injectable drugs, and 50,000 pallets of therapies were destroyed by wind and rain, according to local news outlets, NBC affiliate WRAL and CBS affiliate WNCN. 
    • “At 1.4 million square feet, the facility was one of the largest sterile injectable plants in the world, according to Pfizer’s website. The site made nearly 400 million products every year, including solutions of anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers.
    • “The tornado touched down in Rocky Mount, N.C., at 12:36 p.m., according to a tweet from the county’s government.
    • “Pfizer said there are no reports of workers with serious injuries.” 
  • The Wall Street Journal reports,
    • “A surge in heart procedures and higher demand for cold and flu medicines helped Johnson & Johnson report solid gains in revenue and profit for the second quarter.
    • “J&J’s quarterly earnings are regarded as a bellwether for healthcare because the company has large pharmaceutical, medical-device and consumer-health divisions. The overall improvement in J&J’s results suggests an easing of some of the challenges that have dogged health-product makers in recent years: supply-chain constraints, hospital staffing shortages and Covid-19 pandemic restrictions. “You now have hospital staffing much more on a routine cadence,” J&J Chief Financial Officer Joseph Wolk said in an interview Thursday.” 
  • Healthcare Dive adds,
    • “Abbott on Thursday posted a decline in second-quarter net earnings as demand for its COVID-19 testing supplies continued to wane, but the company raised the outlook for its base business on higher sales of its medical devices and nutrition products.
    • “Excluding COVID-19 tests, organic sales exceeded the company’s expectations with a nearly 12% increase in the quarter.”
  • The Society for Human Resource Management explores the limited impact that the Supreme Court’s affirmative action in education decision may have on employer affirmative action and diversity, equity, inclusion, and accessibility programs.

Midweek Update

David Ermer–Congress, COVID-19, FDA, OPM, U.S. Healthcare–

From Washington, DC,

  • Fedweek compares the House and Senate versions of the appropriations bill that funds OPM and the FEHBP.
  • The Federal Times reports,
    • “Reproductive health advocacy groups and Democratic lawmakers are pressing the Office of Personnel Management on why some insurers offer fewer infertility treatments than they’re required to in federal employee health plans.
    • “In a letter to OPM Director Kiran Ahuja obtained by Federal Times, Rep. Gerry Connolly (D-Va.) and Sen. Tammy Duckworth (D-Ill.) said certain providers under the Federal Employee Benefits Program — which serves 8 million beneficiaries — are denying coverage of standard fertility preservation treatments. * * *
    • “For the 2023 plan year, OPM announced it was requiring all FEHB carriers to “provide coverage for standard fertility preservation procedures for … iatrogenic infertility.” Per KFF, “Iatrogenic, or medically induced, infertility refers to when a person becomes infertile due to a medical procedure done to treat another problem, most often chemotherapy or radiation for cancer.”
  • The Federal Times article contends that FEHB plans are not fully compliant with this mandate. OPM has created a process for members to ask for OPM review of claim decisions (following internal plan reconsideration). This process can work out any compliance kinks.
  • InsiderNJ adds,
    • “Today, U.S. Senator Cory Booker (D-NJ) and U.S. Representative Rosa DeLauro (D-CT) reintroduced the bicameral Access to Infertility Treatment and Care Act, legislation that would require more health insurers to provide coverage for infertility treatment, as well as fertility preservation services for individuals who undergo medically necessary procedures that may cause infertility, such as chemotherapy. * * *
    • “The full text of the bill can be found here.”
  • AHA News informs us,
    • “The Federal Trade Commission and Department of Justice July 19 released for comment through Sept. 18 updated guidance describing how the agencies review mergers and acquisitions to determine compliance with federal antitrust laws. The agencies said the document outlines 13 principles they may use when determining whether a merger is unlawfully anticompetitive and clarifies the frameworks and tools they may use when analyzing a merger with respect to each guideline. 
    • “FTC and DOJ initiated the update with a request for public input in January 2022, and plan to use the comments to update the draft before finalizing the guidelines. For more on the draft guidelines, see the agencies’ fact sheet. AHA intends to submit comments on the proposed guidelines.”
  • Washington Technology tells us,
    • “Maximus is locked in a protest fight after the U.S. Postal Service chose Deloitte Consulting for a $175 million contract to the consulting firm to build a new health benefits system.
    • “By 2025, USPS plans to move that new system for delivering health insurance benefits to its employees. USPS tasked Deloitte Consulting to build the system that would include enrollment processing, eligibility determinations, data analytics and other features, according to solicitation documents on GovTribe.
    • “Maximus filed a protest with the Government Accountability Office on Tuesday to challenge the award. The Office of Personnel Management is managing the contract on behalf of the Postal Service. * * *
    • “A decision from GAO is due Oct. 26.”
  • Cardiovascular Business points out that “The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling nearly 350,000 implantable cardiac devices due to continued issues with their ability to deliver high voltage therapy when necessary.”

From the public health front –

  • The Wall Street Journal reports,
    • “You might know a Covid-19 super-dodger who was infected with the virus but didn’t get sick. Their luck could be written in their genes. 
    • “A DNA variation that affects the immune system can boost a person’s odds of avoiding Covid-19 symptoms, a study found. The work, published Wednesday in the journal Nature, helps explain why some people infected with the virus that causes Covid-19 don’t fall ill. 
    • “The T cells of some people with the variation can find and kill the virus without having seen it before, researchers said. That is because the part of the virus their T cells home in on is similar enough to common coronaviruses they have already encountered.  
    • “There are people out there that have got strong prior immunity from their common coronavirus exposures,” said Danny Altmann, a professor of immunology at Imperial College London, who wasn’t involved in the study. The work could help researchers design better vaccines, Altmann said.” 
  • STAT News relates,
    • “Cancer drugs can burn through tumors like wildfire, killing off the vast majority of malignant cells. But a few stubborn cells often end up surviving, seeding a recurrence of the disease. The prevailing theory behind this drug resistance is built on natural selection: Among the vast and genetically diverse population of cancer cells in a tumor, some have random mutations that help these cells survive an onslaught.
    • “But this is not the full picture,” said Yogesh Goyal, a cancer researcher at Northwestern University. Goyal and his colleagues at the University of Pennsylvania demonstrated in a series of experiments that cancer cells can survive treatments just by having certain genes turned on, even if they were nearly genetically identical to cancer cells that died but had activated different genes.
    • “We think this work stands to really change how we think about therapy resistance,” said Arjun Raj, the study’s co-senior author and a bioengineer at the University of Pennsylvania.
    • “In other words, mutations alone cannot fully explain resistance to cancer therapy. Instead, researchers may need to look more closely at the assemblage of genes turned on or off at any given time in a cancer cell — what scientists call the cell’s transcriptional profile — to better understand whether it will respond to a certain drug, Goyal said.”

From the U.S. healthcare business front —

  • Healthcare Dive lets us know
    • “Elevance’s second-quarter earnings alleviated recent cost trend and utilization concerns, as the health insurer reported lower medical spending than analysts expected.
    • “The payer beat Wall Street expectations for the quarter with revenue of $43.7 billion, up 13% year over year, and profit of $1.9 billion, up 14% year over year. * * *
    • “Elevance reported a medical loss ratio of 86.4%, down 70 basis points year over year due to premium rate adjustments reflecting the post-pandemic cost of care, CFO John Gallina told investors on a Wednesday morning call.”
  • Fierce Healthcare informs us,
    • “Amar Desai, M.D., wrote in a post on LinkedIn Wednesday that he is “thrilled” to come back to the UnitedHealth Group subsidiary as the CEO of Optum Health. Desai previously spent several years in leadership roles at Optum before taking the role of president of healthcare delivery at rival CVS Health.
    • “Desai is also an associate clinical professor of medicine at the Keck School of Medicine at the University of Southern California. He previously served as president of HealthCare Partners, which was acquired in 2019 by UHG as part of DaVita Medical Group.”
  • The Society for Human Resource Management reports
    • “U.S. organizations are budgeting an average increase of 4 percent in 2024, according to consulting firm WTW, which surveyed more than 2,000 U.S. organizations for its Salary Budget Planning Survey. That number is down from the actual increase of 4.4 percent in 2023, and the 4.2 percent increase in 2022, but the projected 2024 figures remain higher than the 3.1 percent salary increase budget in 2021 as well as other increases in pre-pandemic years.”

Tuesday Tidbits

David Ermer–ACA, Generative AI, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front,

  • Health Affairs reports
    • “National health expenditures are projected to grow 5.4 percent, on average, over the course of 2022–31 and to account for roughly 20 percent of the economy by the end of that period. The insured share of the population is anticipated to exceed 92 percent through 2023, in part as a result of record-high Medicaid enrollment, and then decline toward 90 percent as coverage requirements related to the COVID-19 public health emergency expire. The prescription drug provisions of the Inflation Reduction Act of 2022 are anticipated to lower out-of-pocket spending for Medicare Part D enrollees beginning in 2024 and to result in savings to Medicare beginning in 2031.”
  • The U.S. Preventive Health Services Task Force gave an inconclusive grade to screening for lipid disorders in children and adolescents 20 years or younger.
  • The Wall Street Journal offers ways to protect yourself and your family against the ill effects of forever chemicals that may be in your tap water or else in your homes.

From the regulatory front,

  • The Food and Drug Administration “published a safety communication to warn consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, and Well-Being Reality. The devices have not been reviewed by the FDA. The safety and effectiveness of these devices have not been established to diagnose, treat, or cure medical conditions.”
  • HMFA informs us
    • “Hospital price transparency regulations are undergoing changes heading into their fourth year as CMS seeks to step up enforcement while making compliance more straightforward.
    • “As part of the 2024 proposed rule for hospital outpatient payments, CMS is adding to the requirement for hospitals to maintain a machine-readable file of their charges for services. In addition, enforcement actions against hospitals would be publicized even before assessment of civil monetary penalties.
    • “CMS said the impetus for the proposed technical requirements is feedback from “interested parties” that the files would be more beneficial if they were more standardized.
    • “In particular, IT specialists have indicated that the current flexibilities and lack of encoding specifications hinder the machine-readability of the data in the files, presenting a barrier to the intended use of the data,” CMS wrote. “Additionally, hospitals have asked us for more specificity on how they should publicly display their standard charge information, with an emphasis on how they should explain and display their payer-specific negotiated charges.”
    • “The agency also said enforcement would be easier if the files were more consistent.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “In the past 10 years, there has been a dramatic shift in physician practice ownership as less than half of doctors now work in private practices, according to a new analysis.
    • “Between 2012 and 2022, the share of physicians working in private practices fell by 13 percentage points from 60.1% to 46.7%.
    • “In contrast, the share of physicians working in hospitals as direct employees or contractors increased from 5.6% to 9.6% in the same 10-year time period, and the share of physicians working in practices at least partially owned by a hospital or health system increased from 23.4% to 31.3%, according to a benchmark analysis the American Medical Association. * * *
    • “In 2022, 4.5% of physicians worked in a practice owned by a private equity group, similar to the percentage in 2020 when the AMA first added private equity to the analysis.
    • “According to the analysis, there also has been a redistribution of physicians from small to large practices. The share of physicians in small practices (10 or fewer physicians) shrank from 61.4 % to 51.8% between 2012 and 2022. Conversely, the share of physicians in large practices (50 physicians or more) grew from 12.2% to 18.3% in the same 10-year time period.
    • “The shares of physicians in mid-sized practices (those with 11 to 24 and 25 to 49 physicians) remained relatively stable over the last decade.”
  • BioPharma Dive informs us,
    • “Biotechnology startup creator Flagship Pioneering is teaming up with Pfizer to develop 10 new drug candidates, with each company pledging to invest $50 million in the new effort.
    • “Together, Flagship and Pfizer will take stock of the technologies available to the former firm and its affiliated startups, hunting for opportunities to develop medicines aligned with Pfizer’s research priorities. Per deal terms announced Tuesday, Pfizer will fund the development of selected medicines, each of which it can choose to acquire later.
    • “The collaboration involves Flagship’s “Pioneering Medicines” initiative, which has struck similarly structured deals in the recent past with Novo Nordisk and the Cystic Fibrosis Foundation.”
  • Healthcare Dive relates,
    • “Teladoc Health is expanding its partnership with Microsoft, announcing plans to add artificial intelligence tools for clinical documentation to its telehealth platform for hospitals and health systems.
    • “The companies will work to integrate Microsoft Azure’s OpenAI Service and Cognitive Services and Microsoft-owned Nuance’s Dragon Ambient eXperience into its Solo platform, allowing physicians to automatically transcribe clinical notes during virtual patient exams.
    • “Teladoc’s medical group also plans to use DAX Express, a version of the medical scribe that uses the large language model GPT-4 and doesn’t require human authentication, the New York-based telehealth vendor said. Financial terms of the deal were not disclosed.”

From the Rx coverage front, the Drug Channel blog delves into the biosimilars’ challenge to Humira. The article illustrates the relatively new distinction between low-list drug prices and high-list drug prices. Low list prices do not include a manufacturer rebate. The FEHBlog understands that the distinction is driven by the Inflation Reduction Act.

Monday Roundup

David Ermer–ACA, COVID-19, FDA, Generative AI, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front —

  • The Wall Street Journal reports
    • “Parents have a new tool to protect their newborns from a common but potentially deadly respiratory virus that sends tens of thousands of babies to the hospital each year.
    • “The Food and Drug Administration on Monday approved the first drug to protect all infants against respiratory syncytial virus. RSV is the leading cause of hospitalization of infants in the U.S., killing as many as 300 children under the age of 5 each year.  
    • “The FDA said it approved the drug Beyfortus from Sanofi and AstraZeneca based on studies that found it safely prevented the lower respiratory tract infections caused by the virus. * * *
    • “While Beyfortus isn’t a vaccine, it has a similar objective. The injection gives infants antibodies to neutralize the virus before their immune systems are mature enough to generate them on their own.  * * *
    • “Sanofi plans to make Beyfortus available in time for this year’s RSV season. Before the drug can become widely available, CDC advisers will need to recommend the drug’s use.”  
  • The FEHBlog’s favorite columnist on Covid, the New York Times David Leonhardt, let us know, “The United States has reached a milestone in the long struggle against Covid: The total number of Americans dying each day — from any cause — is no longer historically abnormal.” Consequently, the pandemic era is over.
  • In other Covid news, Medscape tells us,
    • “An air monitor made by researchers at Washington University in St. Louis can detect COVID-19 virus in a room with an infected person within 5 minutes. 
    • “The project was a collaboration among researchers from the university’s engineering and medical schools. Nature Communications published the results of their work in the journal’s Monday edition. * * *
    • “The team tested their device both in laboratory experiments where they released aerosolized SARS-CoV-2 into a room-sized chamber, as well as in the apartments of two people who were COVID-positive.
    • “There is nothing at the moment that tells us how safe a room is,” Washington University neurology professor John Cirrito, Ph.D., in a statement. “If you are in a room with 100 people, you don’t want to find out 5 days later whether you could be sick or not. The idea with this device is that you can know essentially in real-time, or every 5 minutes if there is a live virus in the air.”
    • “Their goal is to develop a commercially available air quality monitor, the researchers said.” 
  • Cigna discusses how to help women to stay on track with screenings for common cancers.
  • KFF explains why different BMI standards apply to older folks. For example,
    • “Epidemiologic research suggests that the ideal body mass index (BMI) might be higher for older adults than younger adults. (BMI is a measure of a person’s weight, in kilograms or pounds, divided by the square of their height, in meters or feet.)
    • “One large, well-regarded study found that older adults at either end of the BMI spectrum — those with low BMIs (under 22) and those with high BMIs (over 33) — were at greater risk of dying earlier than those with BMIs in the middle range (22 to 32.9).
    • “Older adults with the lowest risk of earlier deaths had BMIs of 27 to 27.9. According to World Health Organization standards, this falls in the “overweight” range (25 to 29.9) and above the “healthy weight” BMI range (18.5 to 24.9). Also, many older adults whom the study found to be at the highest mortality risk — those with BMIs under 22 — would be classified as having “healthy weight” by the WHO.
    • “The study’s conclusion: “The WHO healthy weight range may not be suitable for older adults.” Instead, being overweight may be beneficial for older adults, while being notably thin can be problematic, contributing to the potential for frailty.”
  • According to STAT News,
    • “At the turn of the century, nearly 18 million women in the United States were battling hot flashes, night sweats, and other symptoms of menopause with hormones. But in 2002, the therapy went into a free-fall when a landmark trial suggested treating menopause with estrogen and progesterone increased the risk of breast cancer and cardiovascular disease. The study was shut down early — and a year later, prescriptions had plummeted to nearly half what they had been in 2001.
    • “More than two decades later, menopause experts have come to think about the results of the trial very differently. Newer research points to more benefits than risks for many healthy women under 60 treating menopause symptoms with hormone therapy. But many women who are good fits still aren’t getting treatment. “The pendulum has been slowly — too slowly — swinging back,” said OB-GYN Mike Green, chief medical officer of menopause telehealth company Winona. 
    • “Winona is part of a new generation of virtual-first health care companies aiming to give that pendulum a push. In the last five years, more than a dozen telehealth companies have started up to serve women in and approaching menopause, including with hormone therapy. 
    • “Women fall through the cracks,” said internist Lisa Larkin, president-elect of The Menopause Society and founder of concierge women’s health network Ms. Medicine. “That’s why the telemedicine business is booming.” 

From the Alzheimer’s Disease front,

  • Medscape tells us,
    • “Eastern and southeastern areas of the US have the highest rates of Alzheimer’s disease (AD), new research shows.
    • “Investigators at Rush University in Chicago, Illinois, found AD prevalence was highest in Maryland, New York, Mississippi, and Florida. At the county level, Miami-Dade in Florida, Baltimore in Maryland, and the Bronx in New York were among the US counties with the highest prevalence of the disease.
    • “Such geographical variations may be due to the unique make-up of regional populations, study investigator Kumar Rajan, PhD, professor of Medicine and director of Rush Institute for Healthy Aging, Rush University Medical Center, in Chicago, told Medscape Medical News.”
  • STAT News relates,
    • Medicare on Monday proposed ending restrictions on how many PET scans patients can receive to detect amyloid plaques in their brains, which will offer physicians more options as they treat patients with a new drug to slow the progression of dementia.
    • The agency that oversees Medicare had previously restricted coverage to a single scan for patients who participated in clinical studies. Advocates had warned that it could cause issues related to a new class of Alzheimer’s drugs designed to clear those plaques.
  • BioPharma Dive calls our attention to
    • “A closely watched experimental drug for Alzheimer’s disease slowed the decline patients typically experience by about half a year in a key clinical trial, according to new results released Monday.
    • “The drug, called donanemab, is being developed by Eli Lilly and works in a similar way as two other medicines recently approved in the U.S. to treat Alzheimer’s. These therapies are designed to break up clusters of “amyloid beta,” a mutated protein that forms toxic brain plaques and has long been viewed as a root cause of the disease. * * *
    • “Along with its presentation, Lilly disclosed it had completed its approval application to the FDA and expects a verdict by the end of the year. The results were also published in the medical journal JAMA.”
  • Reuters adds,
    • “Alzheimer’s disease experts are revamping the way doctors diagnose patients with the progressive brain disorder – the most common type of dementia – by devising a seven-point rating scale based on cognitive and biological changes in the patient.
    • “The proposed guidelines, unveiled by experts on Sunday in a report issued at an Alzheimer’s Association conference in Amsterdam, embrace a numerical staging system assessing disease progression similar to the one used in cancer diagnoses. They also eliminate the use of terms like mild, moderate and severe.”

From the generative AI front, Fierce Healthcare explains how Blue Cross licensee HCSC is using AI to speed up prior authorization.

From the U.S. healthcare business front,

  • The American Hospital Association informs us,
    • “The Federal Trade Commission July 14 voted 3-0 to withdraw two antitrust policy statements related to enforcement in health care markets, calling the 1996 and 2021 statements outdated. The Department of Justice withdrew the same statements in February.  
    • “AHA is deeply disappointed that the FTC made the same mistake as the DOJ in withdrawing antitrust guidelines for hospitals and other health care providers,” said AHA General Counsel & Secretary Melinda Hatton. “Over the years, AHA has urged both federal antitrust agencies to modernize the guidelines to accommodate the need for more flexibility in enforcement actions to support hospitals’ ability to navigate a changing healthcare landscape. And AHA was instrumental in securing appropriate ACO guidance that allowed hospitals to fully participate in that important program. Withdrawing all the guidance without consultation with the field is both unnecessary and reckless.”
  • According to STAT News,
    • “Sanofi will license a new CRISPR enzyme from the startup Scribe Therapeutics in a bid to be the first to develop a safer, simpler, and more scalable cure for sickle cell disease.
    • “The French drugmaker will pay Scribe $40 million upfront and promise another $1.2 billion in potential milestones to license a DNA-cutting enzyme called CasX for use in a potential single-infusion treatment for the serious blood disorder — what’s known as in vivo therapy. CasX was discovered in CRISPR pioneer Jennifer Doudna’s lab, which subsequently spun out Scribe. * * *
    • “The company will have competition on tackling sickle cell in new ways. In 2021, Novartis started collaborating with the Gates Foundation to develop an in vivo therapy. The base editing company Beam Therapeutics has presented data on an approach that still requires cells to be edited outside the body but is much less toxic. And Sana Biotechnology has a program that hopes to target stem cells with virus-like particles. None of the companies, however, have yet begun clinical trials. 

In employment news,

  • HR Dive reports,
    • “The Occupational Safety and Health Administration published Friday its final electronic recordkeeping rule requiring employers with 100 or more employees in certain industries to submit information from the agency’s Forms 300 and 301 once per year.
    • “OSHA’s rule also updates its system for determining which industries are subject to the information submission requirement. In a departure from the proposed rule, OSHA has retained the requirement for employers with 250 or more employees to electronically submit information from Form 300A once per year. Additionally, employers with 20 to 249 employees in certain designated industries will continue to be required to electronically submit information from Form 300A once per year.
    • “Per the rule, the agency will post data gathered via these submissions on a public website, with identifying information — such as employees’ names and contact information — removed. The final rule is effective Jan. 1, 2024.”

Weekend update

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

From Washington, DC,

  • Both Houses of Congress will be in session this week for floor voting and Committee business. Both Houses go on month-long State / District work breaks next week.
  • HR Dive reports
    • “The U.S. Senate on Thursday confirmed the nomination of Democrat Kalpana Kotagal to the U.S. Equal Employment Opportunity Commission. Her nomination as commissioner gives the workplace rights enforcement agency a Democratic majority. 
    • “The Senate voted 49-47 in favor of the Ohio native Thursday [July 13], after invoking cloture Wednesday. Kotagal will serve as the fifth commissioner of the agency with a term expiring July 1, 2027.” 

From the public health front,

  • Fierce Healthcare discusses an interesting United Healthcare population health program called Catalyst which operates in 28 states.
  • NPR Shots advises avoiding heat stroke and staying healthy when it’s hot outside.

From the medical research front,

  • The Wall Street Journal offers an essay about research underway to “get rid of menopause.”
    • “Imagine if women never reached menopause, that dreaded middle-age milestone—or could delay it, or decide when to have it.
    • “Women could remain fertile longer and would have more choice about when to start a family. They wouldn’t struggle with symptoms like hot flashes, mood swings and brain fog in the prime of their careers and family lives.
    • “Even more significantly, women might live longer and healthier lives. Though menopause—a full year without a menstrual cycle—is associated with the end of fertility, it also marks another profound but less recognized change. When the ovaries stop functioning and releasing important hormones, biological aging in women speeds up, increasing the risk of numerous health problems.
    • “Menopause is the single biggest accelerant of the diseases of aging for women across the board, whether it’s heart disease and stroke, autoimmune disorders, osteoporosis or cognitive decline,” says Piraye Yurttas Beim, founder and CEO of a biotech startup called Celmatix focused on improving ovarian health. “It’s the end of the function of a key organ in our body, and we should not normalize it any more than we would normalize tooth decay, osteoarthritis or cognitive decline.” * * *
    • “At Celmatix, the startup founded by Beim, researchers are seeking to develop what’s called an activator of the AMH hormone. A woman could take a drug to reduce the loss of follicles and eggs in her reserve and thus maintain optimal ovarian health and then go off the drug when she wants more eggs to be released to try to get pregnant.”

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front —

  • Homeland Security Today reports
    • “This week, U.S. Senators Gary Peters (D-MI), Chairman of the Homeland Security and Governmental Affairs Committee, and Josh Hawley (R-MO), along with U.S. Representatives James Comer (R-KY) and Jamie Raskin (D-MD), Chairman and Ranking Member of the Committee on Oversight and Accountability, and Nancy Mace (R-SC) and Gerald E. Connolly (D-VA), Chairwoman and Ranking Member of the Subcommittee on Cybersecurity, Information Technology, and Government Innovation, introduced bicameral, bipartisan legislation to protect federal information technology systems. 
    • “The Federal Information Security Modernization Act (FISMA) of 2023 would improve coordination across the federal government to help civilian federal agencies and contractors protect their networks against cybersecurity threats. It also clarifies roles and responsibilities for key agencies that lead federal information security policy and operations.”
  • Cybersecurity Dive tells us,
    • The Biden administration released its implementation plan for the national cybersecurity strategy Thursday, delegating cyber initiatives to a smattering of government agencies.
    • The plan, which is designed to guide the government’s completion of the national cybersecurity strategy, comes four months after the policy blueprint was unveiled.
    • “If the strategy represents the president’s vision for the future, then this implementation plan is the roadmap to get there,” Kemba Walden, acting national cyber director, said Wednesday during a press briefing.
    • “Fundamentally, we are publishing this plan because we will only achieve our goals with a whole-of-society approach,” Walden said. * * *
    • The 57-page document divides the five pillars and 27 objectives of the national cybersecurity plan into a broader series of initiatives.
    • While the implementation plan calls for the majority of initiatives to be completed before the end of fiscal year 2024, 11 are slated to be done in FY23, which closes at the end of September.
  • Cyberscoop adds
    • “As a concept, I generally like the idea of pushing to try and harmonize regulations. There are so many different regulations for different sectors out there that it can be a little bit confusing for owner-operators,” said Will Loomis, associate director of the Atlantic Council’s Cyber Statecraft Initiative.
    • “In pushing for one big set of regulation for all critical infrastructure, you kind of risk missing a lot of the nuance that exists in the differentiation and the realities of different critical infrastructure sectors,” Loomis said.
    • “And as the U.S. government works to assess the scope of the Chinese hacking campaign that utilized a flaw in Microsoft’s cloud computing systems, Loomis said he was disappointed that the implementation plan did not look more closely at cloud security.”
  • The Wall Street Journal points out,
    • “The hack of email accounts of senior U.S. officials including the commerce secretary is the latest feat from a network of Chinese state-backed hackers whose leap in sophistication has alarmed U.S. cybersecurity officials. 
    • “The espionage was aimed at a limited number of high-value U.S. government and corporate targets. Though the number of victims appeared to be small, the attack—and others unearthed in the past few months linked to China—demonstrated a new level of skill from Beijing’s large hacker army and prompted concerns that the extent of its infiltration into U.S. government and corporate networks is far greater than currently known.”
  • In sum, crafting an effective cybersecurity strategy is a tall order.

From the cybersecurity vulnerabilities and breaches front —

  • Bleeping Computer reported on July 11,
    • “HCA Healthcare disclosed a data breach impacting an estimated 11 million patients who received care at one of its hospitals and clinics after a threat actor leaked samples of the stolen data on a hacking forum.
    • “HCA Healthcare is one of America’s largest healthcare facility owners and operators, with 182 hospitals and 2,200 care centers across 21 U.S. states and the United Kingdom.
    • “As first reported by DataBreaches.net, on July 5th, 2023, a threat actor began selling data allegedly belonging to HCA Healthcare on a forum used to sell and leak stolen data. This forum post includes samples of the stolen database, which they claim consists of 17 files and 27.7 million database records.
    • “The threat actor claims that the stolen data consists of patient records created between 2021 and 2023.
    • “The threat actor initially did not offer the database for sale but instead used the post to blackmail HCA Healthcare, giving them until July 10th to” “meet the demands.” This is likely related to financial demands, although it wasn’t explicitly mentioned.
    • “However, after not receiving a response from HCA, the hacker began selling the full database, with other threat actors expressing interest in purchasing the data.”
  • Cybersecurity Dive offers an update on the slow-moving MOVEit file transfer disasters.
    • “More than 300 organizations have been impacted by Clop’s mass exploitation of a zero-day vulnerability that Progress Software first disclosed in late May, according to threat analysts and researchers. Five additional vulnerabilities in the file-transfer service have subsequently been discovered.”
  • Speaking of zero-day vulnerabilities, Security Week reported on July 11
    • “In an unusual move, Microsoft documented “a series of remote code execution vulnerabilities” impacting Windows and Office users and confirmed it was investigating multiple reports of targeted code execution attacks using Microsoft Office documents.
    • “Redmond’s security response pros tagged the unpatched Office flaws with the CVE-2023-36884 identifier and hinted that an out-of-band patch may be released before next month’s Patch Tuesday.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) added five known exploited vulnerabilities to its catalog on July 11 and two more on July 13.
  • HHS’s Health Sector Cybersecurity Coordination Center released its report on June Vulnerabilities of Interest to the Health Sector.
    • “In June 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 June are from Microsoft, Google/Android, Apple, Mozilla, SAP, Cisco, Fortinet, VMWare, and MOVEit. A vulnerability is given the classification as a zero-day if it is actively exploited with no fix available or is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.”
  • HC3 also posted a PowerPoint titled “Artificial Intelligence, Cybersecurity and the Health Sector.”
  • Health IT Security points out
    • The Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) issued a new publication entitled “Health Industry Cybersecurity Coordinated Healthcare Incident Response (HIC-CHIRP).”
    • HIC-CHIRP provides healthcare organizations with a template for navigating a coordinated incident response when faced with disruptive cyber incidents. Specifically, the publication seeks to address healthcare-specific gaps in existing incident response resources.

In ransomware news,

  • Bleeping Computer lets us know,
    • “Data from the first half of the year indicates that ransomware activity is on track to break previous records, seeing a rise in the number of payments, both big and small.
    • “According to a report by blockchain analysis firm Chainalysis, ransomware is the only cryptocurrency crime category seeing a rise this year, with all others, including hacks, scams, malware, abuse material sales, fraud shops, and darknet market revenue, recording a steep decline.”

From the cybersecurity defenses front —

  • CSO Online shares best practices for an effective cybersecurity strategy.
  • Tech Republics discusses Gartner’s 2023-24 cybersecurity outlook.
  • Forbes offers twenty cybersecurity training tips designed to make the training “stick.”

Friday Factoids

David Ermer–Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the U.S. healthcare business front –

  • Healthcare Dive tells us
    • “All eyes were on UnitedHealth’s medical costs when the health insurance giant reported second-quarter financial results on Friday, but rising outpatient utilization among seniors that spooked investors left the payer’s earnings largely unscathed.
    • “UnitedHealth’s medical loss ratio — the share of premiums spent on healthcare costs — was 83.2% in the quarter, higher than the 81.5% notched in the second quarter last year but lower than analyst expectations.
    • “In the second quarter, outpatient care activity among seniors was a few hundred basis points above our expectations,” UnitedHealth CFO John Rex said on a Friday morning call with investors. “Specific orthopedic and cardiac procedures have increased far above that level of variation.”
  • The Wall Street Journal adds
    • “Americans of all ages are seeking far more mental-health care for conditions including anxiety, depression and substance-use problems.
    • “UnitedHealth Group, parent of the nation’s biggest health insurer, said the percentage of people getting psychological visits and other services was up by double digits just since last year, and it believes the shift represents a long-term change. The company said people feel increasingly comfortable seeking help for behavioral-health issues, but it sees a continuing shortage of mental-health-care providers that is leading to problems with access.
    • “The rising use of behavioral-health care was one driver of higher healthcare costs flagged by the company during a call discussing its second-quarter financial results, which overall beat analysts’ expectations.”
  • BioPharma Dive reports
    • “Eli Lilly has agreed to acquire privately held biotechnology company Versanis in a deal that will add an experimental antibody to Lilly’s pipeline of medicines for obesity.
    • “The companies did not disclose a purchase price, but said in a statement Friday that upfront and milestone payments by Lilly to Versanis shareholders could be worth as much as $1.9 billion.
    • “Founded in 2021 by Aditum Bio, Versanis is built around a drug licensed from Novartis. The antibody, called bimagrumab, is designed to block cellular communication via two types of protein regulators and is being studied in people who are overweight or obese.”
  • Beckers Payer Issues points out that “Competition between Blue Cross Blue Shield companies is increasing after a 2022 antitrust settlement that struck down some agreements limiting competition between BCBS Association members, according to a July 13 report from Advisory Board.“
  • Per Reuters
    • “An influential U.S. drug pricing watchdog raised the price estimate of two experimental gene therapies from Vertex Pharmaceuticals (VRTX.O)/CRISPR Therapeutics and bluebird bio (BLUE.O) to as much as $2.05 mln, saying the new price can be cost effective to treat sickle cell disease.
    • “A price of up to $2.05 million a year, higher than the prior estimate in April of up to $1.9 million would meet some commonly used thresholds for cost effectiveness, the Institute for Clinical and Economic Review (ICER) said.”

From the SDOH front, Healthcare IT News notes “Without the need for deep learning and neural network models, researchers were able to use machine learning to extract social determinants of health information on housing challenges, financial stability and employment status from unstructured patient data in electronic health records, a new research report from Regenstrief Institute shows.”

From the plan design front —

  • HR Executive offers six ways to make a primary care strategy blossom. Check it out.
  • Fierce Healthcare lets us know
    • “The Center for Medicare and Medicaid Innovation (CMMI) has released a request for information to design a future episode-based payment model.
    • “The center is looking for feedback on questions related to care delivery, incentive structure alignment, clinical episodes, participants, health equity, quality measures and multipayer alignment, payment methodology and structure, and model overlap, according to the request.
    • “Episode-based payment models intend to address inefficiencies in traditional Medicare fee-for-service beneficiaries, where providers are paid for each item or service. This leads to “volume over value and fragment care,” according to the request.”

From the mental healthcare front,

  • KFF created a brief on the success to date of the 988 national suicide and crisis number.
    • Since its launch in July 2022, the 988 national suicide and crisis hotline has received about 4 million contacts, a 33 percent increase from the year before, according to a new KFF analysis of publicly available data through May 2023. The contacts include more than 2.6 million calls, over 740,000 chats, and more than 600,000 texts. The total number of contacts rises to almost 5 million when nearly 1 million additional contacts from the Veterans Crisis Line (VCL) are included, which were reported by the federal Substance Abuse and Mental Health Services Administration (SAMHSA), but aren’t yet publicly available.

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, Generative AI, Medicare, Mental health care, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC —

  • The Food and Drug Administration announced
    • approve[ing] Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
  • The New York Times adds,
    • The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024.
  • The OTC contraceptive will be available with no member cost sharing from FEHB plan network pharmacies due to the Affordable Care Act’s contraceptive mandate. Per the New York Times,
    • The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.”
  • The American Hospital Association informs us
    • “The Centers for Medicare & Medicaid Services July 13 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.8% in calendar year 2024 compared to 2023. This includes a proposed 3.0% market basket update, offset by a 0.2% cut for productivity.”
  • and
    • “The Centers for Medicare & Medicaid Services July 13 released its calendar year 2024 proposed rule for the physician fee schedule. The rule proposes a decrease to the conversion factor by 3.34%, to $32.75 in calendar year 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and CHIP Reauthorization Act; and a -2.17% budget-neutrality adjustment.  * * * 
      “CMS also proposes several provisions to advance access to behavioral health services. For example, it would create a new benefit category for marriage and family therapists and mental health counselors under Part B. In addition, CMS would establish new payment codes for mobile psychotherapy for crisis services.”\
  • The public comment deadline for both proposed rules is September 11, 2023.
  • STAT News reports
    • “A key Senate health care panel has developed a plan to tackle reforms to middlemen in the pharmacy drug payment system, according to bill text obtained by STAT.
    • “The draft legislation, authored by Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho), includes several measures to regulate how pharmacy benefit managers are paid by health plans to negotiate with drugmakers.
    • “The most significant measure is a bill from Sens. Bob Menendez (D-N.J.) and Marsha Blackburn (R-Tenn.) that would prohibit PBMs from getting any income outside of service fees, and prohibits those service fees from being related to drugs’ list prices.
    • “Other provisions include a bill from Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) to require PBMs to send annual reports to Medicare insurance plans about their rebate and price negotiations, a policy that would ban PBMs from charging Medicaid more than they pay for drugs (a practice called spread pricing), and a mandate for the Department of Health and Human Services to outline acceptable performance measures for pharmacies.”

From the public health front

  • The Wall Street Journal reports
    • Two different arms of the World Health Organization released separate findings on the widely used sweetener aspartame—one calling it safe and the other identifying it as a possible cancer hazard.
    • Here’s what you need to know:
    • Is it safe to drink Diet Coke?
      • Yes, in moderate amounts. Food regulators around the world agree that aspartame is safe. Aspartame has been studied for decades. The WHO reaffirmed its recommendation that people consume no more than 40 milligrams of aspartame a day for each kilogram they weigh—which would be a lot of soda.
      • With around 200 mg of aspartame per 12-ounce can of Diet Coke, that is roughly 16 cans a day for a 175-pound person. People get aspartame from some other food sources, though, and often the presence or amounts of aspartame in them aren’t disclosed. The WHO and other health experts also caution against consuming large amounts of sweetened products, including soda. They recommend drinking water instead.
      • “This is particularly important for young children” whose tastes are developing, said Dr. Francesco Branca, director of the WHO’s department of nutrition and food safety.
    • Obviously, the article continues on with other FAQs, but this is the one that caught the FEHBlog’s attention.
  • The U.S. Preventive Services Task Force finalized its research plan for chronic kidney disease screening.
  • STAT News tells us
    • “Amid ongoing controversy over the cost of medicines, a key Biden administration official told Covid-19 vaccine manufacturers that their next round of shots should be priced reasonably, a move that comes after two key suppliers were accused of price gouging.”
  • The CMS Administration informed insurers and others
    • “As we look toward efforts to provide updated COVID-19 vaccines this fall, we know you may have questions about the shift away from U.S. Government purchasing of vaccines to a more traditional commercial market. To be clear, that shift has not yet occurred, and the currently authorized and approved COVID-19 vaccines continue to be free and widely available nationwide. We also wanted to send these reminders from the Centers for Medicare & Medicaid Services (CMS) about COVID-19 vaccine coverage and encourage you to start planning now for the fall vaccination campaign.
    • “[M]ost private health insurance, like employer-sponsored plans, Marketplace plans, and other individual market coverage that is subject to the Affordable Care Act (ACA) market reforms are required to cover vaccines for COVID-19 authorized for emergency use or approved by the FDA and recommended by the ACIP and their administration, without patient cost-sharing.”
  • Fierce Healthcare relates
    • The Centers for Medicare & Medicaid Services (CMS) is recommending preexposure prophylaxis (PrEP) with oral or injectable antiretroviral therapy to people at risk of HIV without patient cost sharing. * * *
    • Currently, Medicare beneficiaries are only guaranteed access to daily oral PrEP through Part D, facing out-of-pocket costs, said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Injectable PrEP has not been covered traditionally.
  • Roll Call points out
    • “One year after the creation of the three-digit crisis hotline known as 988, officials say the next step is expanding awareness and local crisis care.
    • “More than 4 million people have called, texted or chatted the suicide prevention hotline in the year since its creation, according to Laurel Stine, executive vice president and chief policy officer for the American Foundation for Suicide Prevention.
    • “She estimates that number will grow in the next fiscal year to 9 million contacts.
    • “We have to be mindful that Rome was not built in a day,” she said. “We’ve had a fragmented mental health behavioral health crisis system for a number of years.”
  • Forbes reports on the “worsening” cancer drug shortage which it describes as a resolvable public health emergency.

From the generative AI front —

  • Healthcare Dive notes
    • Generative artificial intelligence could capitalize on the healthcare industry’s wealth of unstructured data, alleviating provider documentation burden and improving relationships between patients and their health plans, according to a new report by consulting firm McKinsey.
    • The report argues generative AI could help payers quickly pull benefits material for members or help call center workers aggregate information during conversations about claims denials. Providers could use AI to take conversations with patients and turn them into clinical notes, create discharge summaries or handle administrative questions from workers at health systems.
    • But healthcare leaders should start planning now if they want to use generative AI, as the risks can be high, the report said. Data fidelity and accuracy is key, so executives should begin assessing the quality of their AI tech stacks and considering potential problems like bias and privacy concerns, according to McKinsey.
  • Econtalk host Russ Roberts held an informative interview with Marc Andreessen about generative AI.