FEHBlog

Tuesday’s Tidbits

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From Washington, DC —

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

From the Medicare front —

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

In other U.S. healthcare news

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

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC —

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

From the research front —

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

From the U.S. healthcare business front —

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

Weekend update

From Washington DC —

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

More from the Medicare front

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

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

Cybersecurity Saturday

From the cybersecurity policy front —

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

From the cybersecurity breaches and vulnerabilities front —

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

From the ransomware front —

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

From the cybersecurity defenses front —

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

End of Week Update

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From Washington, DC

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

From the U.S. healthcare business front —

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

Thursday Miscellany

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From Washington DC —

  • Roll Call reports
    • “[T]he monthlong August recess [which the House began this afternoon] virtually ensures there is no longer enough time to complete fiscal 2024 appropriations by Oct. 1, given that the full Senate has yet to take up any of its bills and the House passed only one.
    • “The Senate now has only four weeks in September to make headway on appropriations, and the House is scheduled to be in session only 12 days that month unless plans change.
    • “Speaker Kevin McCarthy, R-Calif., and Senate Majority Leader Charles E. Schumer, D-N.Y., met Thursday to discuss the appropriations process. McCarthy said he asked Schumer to “get into conference early before Sept. 30 so we can try to get this done.”
  • The American Hospital Association informs us,
    • “The Senate Appropriations Committee today voted 26-2 to approve legislation that would provide $224.4 billion in funding for the departments of Labor, Health and Human Services, and Education in fiscal year 2024, a 7% cut below the prior fiscal year.”
    • “The Centers for Medicare & Medicaid Services today released its fiscal year 2024 Inpatient Rehabilitation Facility Prospective Payment System final rule. The rule increases payments by an estimated 4%, or $355 million, in FY 2024 relative to 2023.”
    • The Centers for Medicare & Medicaid Services today released its fiscal year 2024 final rule for the inpatient psychiatric facility prospective payment system, which updates the IPF payment rate by a net 2.4% in FY 2024.”
    • “The AHA today joined AHIP, the American Medical Association, and Blue Cross Blue Shield Association in urging the Centers for Medicare & Medicaid Services not to implement its proposed HIPAA prior authorization standards for claims attachments due to conflicting regulatory proposals, which “would create the very same costly burdens” that administrative simplification seeks to alleviate.”
      • The last item surprised the FEHBlog.
  • STAT News tells us
    • “To narrow the nation’s deeply entrenched health disparities, a permanent entity with regulatory powers should be created by the president to oversee health equity efforts across the entire federal government, says a report issued Thursday by the National Academies of Science, Engineering, and Medicine.
    • “In its many recommendations, the committee that wrote the report called for Congress to create a scorecard to assess how new federal legislation might affect health equity; urged all federal agencies to conduct an equity audit of current policies; asked the Centers for Disease Control and Prevention to create and facilitate the widespread use of measurements of social determinants of health, including racism; and urged the Office of Management and Budget to oversee efforts to improve the poor and sporadic collection of data about the nation’s racial and ethnic groups.”

From the public health front —

  • The New York Times lets us know,
    • “A new analysis of data from a large clinical trial of healthy older adults found higher rates of brain bleeding among those who took daily low-dose aspirin and no significant protection against stroke.
    • “The analysis, published Wednesday in the medical journal JAMA, is the latest evidence that low-dose aspirin, which slows the clotting action of platelets, may not be appropriate for people who do not have any history of heart conditions or warning signs of stroke. Older people prone to falls, which can cause brain bleeds, should be particularly cautious about taking aspirin, the findings suggest.
    • “The new data supports the recommendation of the U.S. Preventive Services Task Force, finalized last year, that low-dose aspirin should not be prescribed for preventing a first heart attack or stroke in healthy older adults.
    • “We can be very emphatic that healthy people who are not on aspirin and do not have multiple risk factors should not be starting it now,” said Dr. Randall Stafford, a medical professor and epidemiologist at Stanford University.”
  • The Wall Street Journal relates,
    • “To reduce your cancer risk, you don’t need to make it all the way to the gymYou could start by bringing in the groceries. 
    • “People who recorded just under four minutes of vigorous movement every day had a roughly 17% reduced cancer risk compared with people who didn’t log any high-intensity movement, a study published Thursday in the journal JAMA Oncology concluded. The link was stronger for cancers in which exercise has previously been connected to lower risks, including breastcolon, endometrial and bladder cancer. 
    • “The study followed more than 22,000 people who reported that they didn’t exercise but logged minute-long bursts of activity such as walking uphill or carrying shopping bags. It adds to evidence connecting physical activity to better health, even when the movement is modest.
    • “Short bursts of vigorous activity are clearly important for cancer risk at the population level,” said Elizabeth Salerno, a biobehavioral scientist at the Siteman Cancer Center at Washington University in St. Louis, who wasn’t involved in the research. “It’s never too late to get moving in small ways, whether that be parking farther away at the store or taking the stairs.”

Following up on FEHBlog posts from earlier this week —

  • Becker’s Hospital Review identifies “[t]hirteen essential drugs made at Pfizer’s Rocky Mount, N.C., facility — which was recently damaged by a tornado — have a vulnerability score higher than 90 percent, according to a July 26 report from United States Pharmacopeia. 
  • Becker’s Payer Issues offers an overview of Cigna’s defense to “a lawsuit in California that accuses the payer of denying large batches of members’ claims without individual review, thereby denying them coverage for certain services.”

From the U.S. healthcare business front —

  • Healthcare Dive points out,
    • “HCA Healthcare beat Wall Street expectations in the second quarter and raised its full-year outlook off of increases in admissions, emergency room visits and surgeries, as more patients returned to hospitals for care.
    • “HCA, the largest for-profit hospital operator in the country, reported revenue of $15.9 billion in results released Thursday, up from $14.8 billion in the second quarter of 2022. 
    • “HCA’s results were solid, but below elevated investor expectations, analysts commented. That led HCA’s stock to fall 3% in Thursday morning trade following the earnings release.
    • “The Nashville, Tennessee-based operator saw demand for services increase broadly in the second quarter.
    • “Admissions, emergency room visits, inpatient surgeries and outpatient surgeries were up 2.2%, 3.7%, 1.8% and 3.3%, respectively, on a year-over-year basis.”
  • MedCity News tells us,
    • “More than 600 rural U.S. hospitals are at risk of closing due to their financial instability — that’s more than 30% of the country’s rural hospitals. For half of these 600 hospitals, the risk of closure is immediate, according to a new report from the Center for Healthcare Quality and Payment Reform (CHQPR).
    • “All states have rural hospitals that are at risk of closing except for five: Delaware, Maryland, New Jersey, Rhode Island and Utah. In over half of all U.S. states, a quarter or more of rural hospitals are at risk of closure. In 16 states, 40% or more are at risk.”
  • MPRNews reports,
    • “Sanford Health and Fairview Health Services said Thursday they are dropping plans to merge, a proposal that would have created a health care system giant in the Upper Midwest.
    • “A spokesperson with Sanford Health said Sanford’s board of trustees made the decision to stop the process at a noon meeting Thursday and informed Fairview CEO James Hereford a few hours later.” 
  • Fierce Healthcare notes
    • Hello Alpha, a virtual primary care platform, has launched a weight management program for employers that supports sustained weight loss through the lens of whole-person primary care.
    • “The program, Ahead with Alpha, treats and screens for health needs by combining weight loss support with care for more than 100 other medical conditions. The approach combines cost-saving benefits with rapidly-evolving innovations in obesity medicine, the company said.
    • “Members in the program also receive weight loss support like medication management, nutrition counseling with a registered dietitian and progress tracking. And, the program will migrate patients who have successfully lost weight into a lower-cost maintenance program.
    • “Hello Alpha has treated more than 50,000 patients with excess weight and, on average, they experience a sustained 15% reduction in body mass index after 10 or more months in the program, executives said in a press release. That experience has endowed Hello Alpha with expertise in prior authorization, step therapy and formulary management, they said. 
    • “Health can’t be measured in just one metric, as many point solutions claim,” Gloria Lau, Hello Alpha’s co-founder and CEO, said in a press release. “These fragmented solutions that focus on only one aspect of health are creating point-solution fatigue and skepticism. Employers are questioning if these siloed programs deliver real ROI.”

Midweek update

Mount Rushmore

From Washington, DC —

  • STAT News reports
    • “Senators on the Finance Committee on Wednesday nearly unanimously passed a bill to clamp down on drug middlemen but kicked the can down the road on some of the more challenging policies.
    • “The bill would offer some more transparency into the business practices of pharmacy benefit managers, ensure PBMs aren’t skimming off of the money they send to insurers, prohibit them from overcharging insurers, and ensure certain fees in the Medicare program aren’t tied to a drug’s price.”
  • From the Senate Finance Committee, “click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • The House Ways and Means Committee relates,
    • “Congresswoman Nicole Malliotakis, a member of the House Committee on Ways and Means, today announced her legislation, the Protecting Patients from Middlemen Act, passed out of the full committee and will be included in the committee’s Health Care Price Transparency Act of 2023.
    • “Specifically, Malliotakis’ legislation, which was introduced in partnership with Rep. Brad Wenstrup (OH-02), would prohibit prescription drug plans and Pharmacy Benefit Managers (PBMs) in Medicare Part D or Medicare Advantage from charging patients more in drug cost-sharing that the net price of the drug.”
  • AHA News tells us,
    • “The House Ways and Means Committee July 26 voted 25-16 to pass the Health Care Price Transparency Act (H.R. 4822), legislation that would impose additional site-neutral payment cuts and regulatory burdens on off-campus hospital outpatient departments, impose additional Medicare sequester cuts on hospitals, and codify and make changes to hospital price transparency regulations. * * *
    • “In other action today, the committee voted 23-17 to pass the Providers and Payers COMPETE Act (H.R. 3284), AHA-opposed legislation that would impose new regulatory responsibilities on the Department of Health and Human Services regarding consolidation.”
  • Federal News Network informs us,
    • “Federal retirees, and employees looking to retire, have some new resources to help them through the often long and thorny retirement process.
    • “A new series of video tutorials from the Office of Personnel Management lays out, step by step, a couple of key items on the federal retirement to-do list.
    • “With the three new videos, OPM said it hopes to reduce the number of errors from federal retirees when trying to log in to manage their online retirement accounts. And in theory, the videos should also help reduce wait times at retirement services call centers, OPM said, now that more detailed information is readily available to feds who get caught up in some of the early steps of the process.”
  • Forbes reports
    • “The FDA has approved Octapharma’s drug Balfaxar, which is used by patients who require surgery but have seen a reduction in blood clotting factors due to being treated with the blood thinner warfarin.” 

From the public health front —

  • Employee Benefits News offers expert views on the current state of Covid.
  • The National Institutes of Health announced
    • “Researchers have found that people with obstructive sleep apnea have an increased cardiovascular risk due to reduced blood oxygen levels, largely explained by interrupted breathing. Obstructive sleep apnea has long been associated with an increased risk of cardiovascular issues, including heart attack, stroke, and death, but the findings from this study, partially supported by the National Institutes of Health and published in the American Journal of Respiratory and Critical Care Medicine, show the mechanism mostly responsible for the link.
    • “These findings will help better characterize high-risk versions of obstructive sleep apnea,” said Ali Azarbarzin, Ph.D., a study author and director of the Sleep Apnea Health Outcomes Research Group at Brigham and Women’s Hospital and Harvard Medical School, Boston. “We think that including a higher-risk version of obstructive sleep apnea in a randomized clinical trial would hopefully show that treating sleep apnea could help prevent future cardiovascular outcomes.”
  • Medscape considers where exercise boosts cognition.
  • Fierce Healthcare lets us know,
    • “One in three counties in the U.S. is considered a maternal healthcare desert.
    • “Since that statistic was dropped back in October 2022 by March of Dimes, care in corners of the country has only continued to dry up. In response to the crisis, providers are using every seed in their seed bag and looking to “multimodal” technology strategies to predict health emergencies before they happen.
    • “Those multimodal approaches combine telehealth, remote patient monitoring (RPM) and text messages to identify high-risk patients. High blood pressure monitoring and hypertension screening are currently recommended for pregnant patients by the U.S. Preventive Services Task Force, as heart disease and stroke are two of the leading causes of maternal mortality.
    • “Lucienne Ide, M.D., is the CEO of the digital health company Rimidi. She sees the country teetering on an inflection point.
      • “We’re at this fork in the road of looking at what we could do with technology, identifying high-risk women and getting them into the programs where we’re proactively and earlier identifying something dangerous and doing something about it,” Ide told Fierce Healthcare.
      • “But the alternate narrative is really, really bad, and it’s going to get worse. It’s not like, ‘Here we are today, and we could do better.’ No, here we are today, and it’s going to get worse, but we can actually do better,” she said.

From the U.S. healthcare business front —

  • Per Fierce Healthcare,
    • “As hospitals acquire ambulatory care centers, consumers are more likely to be forced to pay outpatient facility fees for routine care traditionally covered by physician offices at lower costs.
    • “These new costs, appearing seemingly out of nowhere to the average consumer through out-of-pocket spending and premium increases, can add up to hundreds or thousands of dollars in additional expenses for a patient, according to a report from Georgetown University’s Center on Health Insurance Reforms.
    • “Outpatient facility fees cover a hospital’s operational expenses. But when hospitals acquire physician practices, that usually generates another outpatient facility bill, eventually passing on the cost to the patient. Consumers are often unaware that they are now responsible for an extra cost.”
  • Healio reports that the growth of telehealth in cancer care continued after the initial surge during the COVID-19 pandemic.
  • Per Healthcare Dive, the path toward reducing physician burnout is widening.
    • “Amazon has become the latest tech giant to announce a clinical documentation service that allows providers to automatically create medical notes using generative AI.
    • “The Amazon Web Services tool announced Wednesday, called HealthScribe, allows providers to build clinical applications that use speech recognition and generative AI to create transcripts of patient visits, identify key details and create summaries that can be entered into an electronic health record.
    • “HealthScribe is being previewed for two specialties: general medicine and orthopedics. An Amazon spokesperson said AWS could expand to additional specialties based on client feedback. HealthScribe costs users a set amount per second of audio processed each month.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Department of Labor announced
  • STAT News adds,
    • “The new rule would force insurers to evaluate their own networks to measure not just whether they’re offering adequate mental health and addiction coverage but also whether patients are truly accessing it.
    • “This rule will ensure that we have true parity,” Neera Tanden, President Biden’s domestic policy advisor, said during a press call. “It will help ensure we finally fulfill the promise of mental health parity required under the law, to ensure that mental health is covered just like physical health.”
  • The public comment deadline will occur in late September.
  • The FEHBlog notes that health plans cannot coerce providers into their networks. The FEHBlog thought that hub and spoke tele-mental health networks would fill the gap, but that apparently hasn’t happened.
  • AHIP announced
    • “AHIP, the American Medical Association (AMA), and the National Association of ACOs (NAACOS) today announced the release of data-sharing best practices that organizations may voluntarily adopt to support a sustainable future for value-based care. The playbook, The Future of Sustainable Value-Based Care and Payment: Voluntary Best Practices to Advance Data Sharing, is intended to advance the adoption of value-based care arrangements in the private sector that could have a greater impact on the quality and equity of care and ease participation by fostering voluntary alignment of data sharing practices.”
    • Check it out.
  • The National Coordinator for Health Information Technology released on July 20, 2023,
    • “ONC Standards Bulletin 2023-2 (SB23-2) [which] describes the background of United States Core Data for Interoperability (USCDI) and the development of the USCDI Version 4 (USCDI v4) * * *. USCDI is a standard developed and adopted by ONC on behalf of the U.S. Department of Health and Human Services (HHS) that sets the technical and policy foundation for the access, exchange, and use of electronic health information to support nationwide, interoperable health information exchange. USCDI benefits a wide range of entities, individuals, and other interested parties, including federal agencies supporting health and healthcare, hospitals, research organizations, clinicians, and health IT developers. ONC publishes new versions of USCDI annually, with a draft version in January and a final version in July. This publishing cadence keeps pace with medical, technological, and policy changes. USCDI v4 includes new data elements that advance the Biden-Harris Administration’s priorities of advancing equity, diversity, and access across all healthcare settings.
    • “SB23-2 describes the ONC approach for the continued expansion of USCDI, as well as the specific priorities for adding new data elements to USCDI v4. This bulletin also includes discussion of the feedback received on the Draft USCDI v4, including recommendations received from the ONC Health IT Advisory Committee (HITAC).”
  • The U.S. Preventive Services Task Force gave a draft inconclusive grade for “screening for speech and language delay and disorders in children age 5 years or younger.” The USPSTF previously gave the same grade to the screening service in 2015. The public comment deadline is August 21, 2023.
  • FedSmith notes that the OPM final rule expanding FEDVIP eligibility will add “over 70,000 federal employees and 118,000 Postal employees” to the pool of employees eligible for FEDVIP.

From the public health front —

  • U.S. News reports
    • “Both coronavirus emergency department visits and test positivity increased, according to CDC data. The agency no longer tracks COVID-19 cases. Instead, it focuses on hospitalizations and deaths, which don’t yet show an increase.
    • “The CDC reported last week that it was the first time since January that COVID-19 metrics showed an increase. The uptick is small, but it’s a notable reversal after months of declining coronavirus numbers.
    • “Certain COVID-19 indicators continued their recent rise last week, according to data from the Centers for Disease Control and Prevention.”
  • HHS’s Agency for Healthcare Research and Quality issued a roundtable report about “Optimizing Health and Function as We Age.”
  • Yahoo News tells us,
    • “Drugmaker Pfizer Inc said over 30 drugs, including injections of painkiller fentanyl and anesthetic lidocaine, may see supply disruption after a tornado destroyed a warehouse at its Rocky Mount, North Carolina, plant last week.
    • “The company sent a letter late last week to its hospital customers saying it had identified around 64 different formulations or dosages of those more than 30 drugs produced at the plant that may experience continued or new supply disruptions.
    • “The company has placed limits on how much supply of those drugs its customers can buy.”
  • Medscape shares CDC guidance about the two new RSV vaccines for adult that the FDA and CDC recently approved.
    • “Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinician, say authors of a Centers for Disease Control and Prevention report published Friday.
    • “Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.

From the U.S. healthcare business front,

  • BioPharma Dive informs us,
    • “Biogen on Tuesday said it will eliminate 1,000 jobs as part of a cost-cutting drive that it expects will save $1 billion in annual operating expenses by 2025.
    • “The company plans to invest $300 million of those savings into product launches as well as research and development, which it has spent the first half of this year reorganizing under new CEO Chris Viehbacher.
    • “There’s been a complete redesign of Biogen,” Viehbacher said on a conference call with analysts. “This is an opportunity to make sure that in this year, before we get into [new] product launches, that we are truly fit for growth.”
  • STAT News lets us know that “As Alzheimer’s drugs hit the market, the race for early detection blood tests heats up” and offers an interview with the American Medical Association’s new president Dr. Jesse Ehrenfeld.
  • Fierce Health relates,
    • “Teladoc’s second-quarter revenue jumped 10% to $652 million, boosted by strong growth in its BetterHelp direct-to-consumer mental health segment.
    • “The telehealth giant also narrowed its losses this past quarter to a net loss of $65 million, or a loss of 40 cents per share, compared to a loss of $3 billion for the second quarter of 2022. Both results beat Wall Street estimates.
    • “The Zacks Consensus Estimate for Teladoc’s second-quarter earnings per share was pegged at a loss of 44 cents and revenue of $649 million.”

In low-value care news, the National Institutes of Health tells us, “A device known as a pessary, thought promising for reducing preterm birth risk due to a short cervix, appears no more effective than usual medical care, according to a study funded by the National Institutes of Health. A pessary is a rounded silicone device that fits around a cervix that has shortened, to keep it from opening and leading to miscarriage or preterm birth. The device is typically removed before the 37th week of pregnancy.”

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC

  • OPM has finalized a rule
    • “to expand eligibility for enrollment in the Federal Employees Dental and Vision Insurance Program (FEDVIP) to additional categories of Federal employees and certain Postal employees. This rule also updates the provisions on enrollment for active duty service members who become eligible for FEDVIP as uniformed service retirees pursuant to the National Defense Authorization Act of 2017 (fiscal year 2017 (FY17) NDAA). In addition, this rule adds exceptions to decrease an enrollment type and to cancel an enrollment for certain enrollees who may become eligible for dental and/or vision services from the Department of Veterans Affairs (VA).” 
  • Per Medscape, the Food and Drug Administration
    • “today approved quizartinib (Vanflyta) for adults with acute myeloid leukemia (AML) that carries the FLT3-ITD genetic mutation.
    • “The FDA also approved the LeukoStrat CDx FLT3 Mutation Assay to determine whether patients have this mutation.
    • “The agency granted quizartinib a first-line indication for use in combination with standard chemotherapy — cytarabine and anthracycline induction followed by cytarabine consolidation — and as maintenance monotherapy afterward, in adults whose tumors express FLT3-ITD.” * * *
    • “In a company press release, the drug’s manufacturer Daiichi Sankyo said quizartinib will be available in the US soon.”
  • Per Fierce Healthcare, the Federal Trade Commission expanded its war on prescription benefit managers by withdrawing earlier guidance that protected PBMs.

Speaking of war, STAT News reports

  • “A new lawsuit accuses Cigna of using an algorithm to automatically deny claims in bulk instead of individually reviewing each case, putting patients on the hook for bills the health insurer otherwise would have paid.
  • “The complaint filed Monday in the Eastern District of California says Cigna uses a system called PXDX to identify discrepancies between diagnoses and the tests and services it covers for those ailments. The company then allegedly denies claims in bulk without looking into each coverage request. California law requires insurers to give each claim a “thorough, fair, and objective investigation.”

For the past twenty years, health claims have been submitted and processed electronically. This is nothing new. The article adds that Cigna plans to mount a defense. The FEHBlog trusts that the court will see the light.

From the public health front,

  • MedPage Today tells us
    • “The prevalence of hepatitis C virus (HCV) infections in pregnant women increased 16-fold over a 21-year period, with associated higher risks of adverse perinatal outcomes, according to a cross-sectional study.
    • “Among more than 70 million hospital admissions for childbirth or spontaneous abortion in the U.S. from 1998 through 2018, the prevalence of HCV-positive pregnancies increased from 0.34 (95% CI 0.26-0.41) cases per 1,000 pregnancies to 5.3 (95% CI 4.9-5.7) cases per 1,000 pregnancies, reported Po-Hung (Victor) Chen, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, and colleagues in JAMA Network Open. * * *
    • “Overall, our data support the recommendations for universal HCV screening with each pregnancy proposed by the Centers for Disease Control and Prevention and American College of Obstetricians and Gynecologists,” Chen and team wrote. “Perinatal care and delivery may be the initial healthcare exposure for many women. These touchpoints represent an opportunity for health care professionals to identify HCV infection and link women and their children to appropriate specialist care.”

In medical and drug research news

  • The National Institutes of Health announced,
    • “Statins, a class of cholesterol-lowering medications, may offset the high risk of cardiovascular disease in people living with HIV by more than a third, potentially preventing one in five major cardiovascular events or premature deaths in this population. People living with HIV can have a 50-100% increased risk for cardiovascular disease. The findings are published in the New England Journal of Medicine.
    • “This research suggests that statins may provide an accessible, cost-effective measure to improve the cardiovascular health and quality of life for people living with HIV,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), a study funder. “Additional research can further expand on this effect while providing a roadmap to rapidly translate research findings into clinical practice.”
  • BioPharma Dive reports
    • “Roche will partner with Alnylam Pharmaceuticals to study a promising new treatment for high blood pressure, becoming the latest large drugmaker to commit in a big way to the often lengthy and expensive process of developing new medicines for the heart. 
    • “Through a deal announced Monday, Roche will pay Alnylam more than $300 million upfront to share rights to the experimental treatment, called zilebesiran. The Swiss pharmaceutical company will also fund the majority of the costs for a large clinical trial to test whether zilebesiran can lower the risk of dangerous cardiovascular events like heart attacks and strokes. 
    • “With this collaboration, we now can develop zilebesiran in a more robust way, allowing us to have cardiovascular outcomes data in hand at launch to ensure results relevant not only for health authorities but also for access and clinical practice in order to ultimately reach as many patients as possible,” Alnylam CEO Yvonne Greenstreet said in a statement.” 
  • BioPharma Dive adds
    • “Gilead Sciences has stopped a closely watched trial involving an experimental cancer drug the company acquired three years ago in a roughly $5 billion deal, marking the latest setback in the company’s plans to grow its oncology business.
    • “According to Gilead, a Phase 3 study testing its drug magrolimab in patients with the bone marrow cancer myelodysplastic syndrome, or MDS, was discontinued because treatment proved ineffective at an interim analysis. Safety findings were “consistent” with the drug’s profile and what’s typically observed with MDS patients, the company said late Friday. It didn’t provide details.
    • “Gilead acquired magrolimab through a buyout of biotechnology company Forty Seven. The drug is still being evaluated in two other pivotal trials in acute myeloid leukemia, with results expected next year. However, after Friday’s announcement, Wall Street analysts appear to be viewing those trials with more skepticism.”

From the U.S. healthcare business front —

  • MedCity News points out that “When asked what the key issues influencing benefits strategy are, 80% of employers said competition for talent, 67% said rising costs, 41% said a focus on inclusion and diversity and 39% said increasing mental health problems, according to a recent Willis Towers Watson survey.”
  • Fierce Healthcare relates
    • “While payers are facing headwinds going into the latter part of this year, the ongoing financial impacts of healthcare’s labor shortage will be felt in the hospital sector far longer, according to a new report from analysts at Moody’s Investors Service.
    • “The “acute” impacts of labor issues have tapered off, according to the report, but “the budgetary aftershocks will reverberate for years to come.” The analysts expect that the labor issues will pull down hospitals’ operating results through 2024, if not longer.
    • “For example, though conditions have improved, the industry’s nursing shortage is expected to extend through 2030, according to projections from the Bureau of Labor Statistics. This will force hospitals and other providers to develop and roll out new strategies that blunt the impacts, the Moody’s analysts said.
    • “Hospitals are benefiting from some expense relief as staffing has become easier and the need to use pricey contract labor has decreased,” the analysts wrote in the report. “But it will take time for improved margins to follow, and labor issues will remain an underlying sector challenge.”

Weekend update

Photo by Michele Orallo on Unsplash

From Washington, DC —

From the mental health coverage front —

  • Fierce Healthcare tells us,
    • “The United Health Foundation, the company’s philanthropic arm, each year releases America’s Health Rankings, which dive into major healthcare trends across the country. The latest analysis of that data examines how different populations are experiencing the rising tide of mental health concerns.
    • “For example, adults with disabilities were 3.5 times more likely to report frequent mental distress and 3.5 times more likely to have had a major depressive episode in the last year.
    • “This data is highlighting the need to take a closer look,” said Yusra Benhalim, M.D., senior national medical director at Optum Behavioral Health Solutions, in an interview. “I think we need to kind of lean in a little bit more and understand what the experience is like for individuals with disabilities.”
  • Health Affairs Forefront considers whether the private sector lead in addressing this mental health equity crisis. The FEHBlog thinks it can.

From the generative AI front —

  • The Wall Street Journal reports,
    • “Hundreds of doctors across the U.S. have entrusted recordings of their private talks with patients to a startup promising to turn the conversations into usable medical records through artificial intelligence.
    • “The technology makes multiple errors while producing the reports, such as failing to use correct medical terminology and adding medicines a patient isn’t taking, according to current and former workers.
    • “To fix those errors, health-tech startup DeepScribe relies on 200 human contractors to listen to the medical conversations and revise the records, the company’s founders said. The workers also use Google searches to find billing codes.”
  • This reminds the FEHBlog of a situation that occurred nearly thirty years ago. A client decided to use then new scanning technology to feed paper claims into its claims system for auto-processing. The client wound up needing at least a hundred people to correct errors in the scans. Over time the technology improved, and human assistance dropped off to reasonable levels. The FEHBlog is certain that, in due time, generative AI will be able to create these reports without human assistance.

From the U.S. healthcare business front, NPR warns providers have begun to bill patients and their health plans for responding to messages posted on the provider’s patient portal. Before long, generative AI will be able to reply on the doctor’s behalf.

From the wellness front, Fortune Well shares expert advice on four habits that aging folks need to adopt, besides exercise, to stay fit.

Check out last Monday’s Econtalk episode in which Russ Roberts interviews Lydia Dugdale about her book, the Lost Art of Dying.