Midweek report

David Ermer–Uncategorized–

From Washington, DC,

  • Per a House of Representatives news release,
    • “Today, the House Appropriations Committee met to consider the Fiscal Year 2027 Financial Services and General Government Appropriations Act. The measure was approved by the Committee with a vote of 34 to 28.” * * *
    • “A summary of the bill is available here.” * * *
  • Federal News Network adds,
    • “The prospects of a civilian federal pay raise next year are continuing to diminish, after House appropriators made no mention of a pay increase in their 2027 spending legislation.
    • “The House Appropriations Committee’s financial services and general government (FSGG) bill for fiscal 2027, which advanced along party lines Wednesday evening, says nothing on funding for a civilian pay raise. Although not yet final, that increases the chances federal employees will miss out on a salary increase next year.”
  •  A House Education and Labor subcommittee shared the testimony presented to its members during its PBM business model hearing today.
  • The Wall Street Journal offers seven takeaways from HHS Secretary Robert F. Kennedy Jr.’s numerous recent appearances before Congressional committees.
  • Healthcare Dive informs us,
    • “Prices for some healthcare services after arbitration under the No Surprises Act were much higher than the same in-network commercial prices before the law was passed, according to new research out this week.
    • “In 2024, prices for imaging after arbitration were 767% higher than average prices in Medicare. For comparison, the same imaging prices were roughly 200% higher than Medicare prices before the No Surprises Act was passed, according to an analysis published by the Brookings Center on Health Policy.
    • “Arbitration decisions in emergency care, imaging and pediatric critical care tended to skew more closely to amounts that providers offered during negotiations, rather than those offered by insurers, according to the analysis.” * * *
    • [This] Brookings research compliments other studies that have found the No Surprises arbitration process raises healthcare costs. One study published in Health Affairs last year found that IDR created an estimated $5 billion in costs between 2022 and 2024, which could eventually result in higher insurance premiums for consumers.”
  • Per an HHS news release,
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), is today announcing the first set of research teams for its Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative, which will collectively fund up to $139.4 million to help spur new, effective therapies for behavioral health. As part of the Trump Administration’s Executive Order to Accelerate Medical Treatments for Serious Mental Illness, EVIDENT will allocate at least $50 million to match state government investments in psychedelic research for populations with serious mental illness.”
  • MedPage Today adds,
    • “From July 2022 [when the 988 mental health line was launched] through December 2024, 35,529 suicides among individuals ages 15 to 34 were observed compared with 39,901 expected suicides based on trends before the launch of the lifeline, corresponding to an 11% reduction (95% CI 8.7-13.1), reported Anupam B. Jena, MD, PhD, of Harvard Medical School in Boston, and co-authors in a research letter in JAMA.
    • “After replacing the previous 10-digit number for suicide and crisis services with the 3-digit number and investing more than $1.5 billion to expand crisis center capacity and workforce nationwide, “988 appears to be working where it matters most, in reducing suicide deaths among the young people who use it the most … saving lives, at scale, within a few years of launch,” said co-author Vishal R. Patel, MD, MPH, also of Harvard Medical School.
    • “Prior evidence for the lifeline was mostly indirect: higher call volumes, positive caller surveys, reductions in same-day distress,” Patel told MedPage Today. In contrast, this study shows that the lifeline actually affects suicide mortality at the population level, he noted.”
  • HR Dive relates,
    • “The U.S. Department of Labor’s Wage and Hour Division on Wednesday announced a proposed rule to streamline joint employer status under the Fair Labor Standards Act, the Family and Medical Leave Act, and the Migrant and Seasonal Agricultural Worker Protection Act, according to a department press release.
    • “The rule would create “a single nationwide standard that both derives from commonalities in federal court precedent where available and resolves significant differences among the circuit courts where they exist,” DOL said, to “ensure employees and employers have a clear, consistent understanding of when multiple employers are jointly responsible for protecting the wages and other rights of an employee.”

From the Food and Drug Administration front,

  • Fierce Pharma reports
    • ‘Merck is carving out its own place in the evolving HIV treatment space with an FDA approval for its Idvynso, a combination regimen that brings its novel islatravir to market for the first time and serves as the cornerstone of what could be a lucrative HIV franchise for the company. 
    • “Idvynso is a once-daily, two-drug oral pairing of Merck’s doravirine and islatravir. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that has been commercialized since 2018 as part of Merck’s Pifeltro and Delstrigo, while islatravir is a newer nucleoside reverse transcriptase translocation inhibitor (NRTTI) that represents the “anchor medicine” in a number of other HIV combos that the company is advancing.
    • “The doravirine and islatravir combo’s debut is specifically targeted at patients who are switching from other HIV treatments and will be available in pharmacies after May 11, Merck said in its April 21 press release.” 
  • STAT News relates,
    • “The Swiss drugmaker Roche on Tuesday presented the latest data for its experimental multiple sclerosis drug, setting the stage for the company to seek approval for a medicine that it believes can cut relapse rates and slow the progressive disability the disease causes.  
    • “Now the test is whether the drug, called fenebrutinib, can win the regulatory green light.
    • “While three late-stage trials of the drug have shown it to be effective, analysts have homed in on some potentially worrying liver safety signals, an issue that previously prompted the Food and Drug Administration to reject an MS therapy developed by Sanofi. In data released Tuesday, researchers also disclosed that there were two drug-related deaths among patients who took fenebrutinib.  
    • “Roche has touted the potential of fenebrutinib — an oral tablet — noting that it hit its efficacy mark across different types of MS and offers a new approach for treating the disease. It’s also sought to differentiate its therapy from Sanofi’s rejected drug, called tolebrutinib.”

From the public health and medical / Rx research front,

  • BioPharma Dive reports,
    • “Revolution Medicines’ closely watched pancreatic cancer drug helped control tumors when administered early in a patient’s disease course, stimulating a response in at least half of those who got it either as a single treatment or alongside chemotherapy, according to trial results unveiled at a medical meeting Tuesday.
    • “The findings disclosed at the American Association for Cancer Research’s annual convention come from studies testing the therapy, daraxonrasib, in first-line pancreatic cancer. They follow, by a week, Phase 3 data showing the drug nearly doubled survival in people whose disease had progressed after an earlier treatment, sparking a share surge that has launched the company’s valuation past $30 billion.
    • “The Food and Drug Administration gave Revolution a special regulatory fast-pass that could lead to a clearance within weeks of an approval submission.”
  • and
    • “A three-drug combination involving Merck & Co.’s Welireg failed to significantly delay tumor progression or extend survival in a Phase 3 trial of patients newly diagnosed with the most common form of kidney cancer, setting back the big drugmaker’s plans to further expand use of the medication.
    • “The study evaluated Welireg alongside Merck’s immunotherapy Keytruda and Eisai’s Lenvima in first-line clear cell renal cell carcinoma and compared that regimen to the Keytruda-Lenvima tandem alone. Merck didn’t provide specifics but said that drug trio — as well as a separate one also tested in the trial — missed the study’s dual main objectives at an interim analysis.
    • “Merck noted how the findings don’t affect other ongoing studies in “Litespark,” the broad program it’s jointly conducting with Eisai and that includes other Welireg tests. The Food and Drug Administration is reviewing an application based on results from one Litespark study that would expand use of Welireg earlier in kidney cancer.”
  • MedPage Today relates,
    • “In a survey of roughly 45,000 U.S. adults representing more than 257 million people, 9% said they had obesity and drank heavily over the past month, while 3.8% said they had both obesity and met criteria for alcohol use disorder (AUD) over the past year, reported researchers led by Bryant Shuey, MD, MPH, of the University of Pittsburgh.
    • “Overlapping heavy drinking and obesity was most common among men ages 35 to 49 (13.6%), women ages 26 to 34 (11.9%), and Black individuals (11.9%). AUD and obesity overlap was highest for men and women ages 26 to 34 (6.2% and 5.1%), people without insurance, and those on Medicaid, the findings in JAMA Internal Medicine showed.
    • “Shuey and colleagues said the findings on this high-risk population call for public health and clinical interventions tailored to younger and middle-age adults, especially the uninsured and those on Medicaid, to prevent liver disease and liver-associated deaths.” * * *
    • “Given the effectiveness of GLP-1 drugs “for weight loss and metabolic dysfunction–associated steatohepatitis, expanding access for patients with co-occurring risky alcohol use and obesity may reduce liver disease burden,” they argued.”
  • Health Day tells us,
    • “Pregnancy-related deaths in the U.S. increased sharply during the COVID-19 pandemic, particularly among Black women, a new study reports.
    • “Deaths remain significantly higher today for Black mothers, even though they’ve returned to pre-pandemic levels for most other groups, researchers reported in the journal Obstetrics & Gynecology.
    • “We saw a dramatic increase in pregnancy-related deaths during the COVID-19 pandemic, but the recovery has not been equal across all groups,” said senior researcher Dr. Lindsay Admon, an associate professor of obstetrics and gynecology at the University of Michigan Medical School.
    • “We need to better understand what’s driving these differences so we can develop solutions that reduce maternal deaths and improve outcomes for everyone,” she said in a news release.”
    • * * * “Results showed that maternal deaths during or just after pregnancy rose more than 60% during the pandemic, from about 20 deaths per 100,000 live births in 2019 to 33 per 100,000 in 2021.
    • “Most of the pandemic increase was linked to COVID-associated deaths, researchers found. Early pregnancy death rates rose by 7.5 per 100,000 live births, and later pregnancy deaths by 3.7 per 100,000.
    • “By 2023 and 2024, early pregnancy deaths had returned to pre-pandemic levels, but those late in pregnancy and after pregnancy remained elevated.
    • “All death rates remained notably higher for Black mothers, researchers found.”
  • Per an NIH news release,
    • “In a National Institutes of Health (NIH)-funded study, researchers developed a cancer assessment tool that can identify high-risk patients and the tumor cells linked to that risk. The model, called scSurvival, uses a machine learning framework designed to analyze large-scale data at single-cell resolution. 
    • “With NIH support, Oregon Health & Science University (OHSU) tested the model on clinical data from more than 150 cancer patients. The tool predicted survival outcomes and linked specific cell populations to higher risk. 
    • “A risk assessment tool that not only tells you who may be at higher risk, but also provides clues as to why, could really help in these difficult cancers” said Anthony  Letai, M.D., Ph.D., director of NIH’s National Cancer Institute (NCI).”  

From the U.S. healthcare business and artificial intelligence front,

  • Beckers Hospital Review relates,
    • “Franklin, Tenn.-based Community Health Systems reported an operating income of $281 million (9.5% margin) on revenues of $3 billion in the first quarter of 2026, down slightly from a $284 million operating gain (9% margin) in the same period last year. 
    • “However, after interest payments on debt and other expenses, CHS reported a net loss of $58 million in the first quarter, compared to a $13 million loss in the first quarter of 2025. 
    • “We are pleased with the continued, tangible progress on our key priorities, demonstrated by improvements in quality scores, patient experience and physician satisfaction measures, and investments in growth opportunities,” CEO Kevin Hammons said in an April 21 news release. “In the face of a dynamic macroeconomic environment, we remain focused on the variables within our control and believe we are positioning the company for long-term success and value creation.”
  • and
    • “Optum Rx — the pharmacy benefit manager for UnitedHealth Group — claims its “PreCheck” prior authorization tool not only cuts prescription approval times but also reduces denials and appeals.
    • “UnitedHealth Group gave an update on the tool in an April 21 earnings call. Optum CEO Patrick Conway, MD, said denials due to missing information dropped by 68% and appeals were down 88%, thanks to PreCheck. He said PreCheck has been “easing interactions for clients, members and providers.”
    • “Dr. Conway reaffirmed that PreCheck has axed prescription approval time from eight hours to fewer than 30 seconds. 
    • “Optum Rx announced an expansion of PreCheck in November, alongside its decision to eliminate reauthorization requirements for 40 medications. In the November release, UnitedHealth Group said, as of this year, the PreCheck platform covers more than 45 medications and is leveraged across 20 health systems.”
  • Healthcare Dive tells us,
    • “Amazon is launching a weight management program with access to GLP-1s through its One Medical primary care chain, in a bid to help consumers more easily access the popular weight loss drugs alongside supportive care, the retail and technology giant said Tuesday. 
    • “Under the program, users work with a dedicated provider to receive a GLP-1 medication as well as follow-up care, so patients can adjust their treatment and address related health concerns like cardiovascular disease and diabetes. 
    • “Patients can also access prescriptions for “transparent pricing” on Amazon Pharmacy, the company said. New GLP-1 pills start at $25 per month with insurance or through cash-pay options as low as $149 per month.”
  • Fierce Pharma informs us,
    • “As pharma giants slash headcounts and routinely strike billion-dollar M&A deals, another trend is steadily playing out at many of the largest drugmakers: adoption of AI on a corporate scale.
    • “Mark Merck as a participant in this movement. On Wednesday, the company revealed a partnership with Google Cloud as it works to undergo an “agentic AI enterprise transformation.”
    • “As part of an investment in Google Cloud valued at up to $1 billion, Merck will get access to the tech giant’s agentic AI platform across its R&D operations, manufacturing, commercial teams and corporate functions.
    • “Notably, the deal involves Google Cloud engineers working directly with Merck’s teams to onboard the tech, according to the April 22 press release. In a statement, Dave Williams, Merck’s chief information and digital officer, noted that the AI push comes “as we enter one of the most significant launch periods in our company’s history.”
  • Beckers Health IT adds,
    • “UnitedHealth Group is betting big on AI in 2026 — $1.5 billion to be exact. 
    • “During the company’s Q1 earnings call, leaders fleshed out how that investment is materializing.
    • “Think about it this way: A third of this is explicitly invested into software products and platforms, accelerating Optum Insight’s transition of business models into an AI-first software and services firm. The remaining two-thirds is spent across signature end-to-end processes and functions across UnitedHealth Group,” Optum Insight CEO Sandeep Dadlani said. 
    • “Optum Insight, the technology-enabled services business under UnitedHealth, will manage internal AI use cases, which could eventually be translated and commercialized beyond the company. UnitedHealth expects a 2-to-1 return, much of it within the next 12 to 18 months.”
  • and
    • “Michael and Susan Dell have surpassed $1 billion in total giving to the University of Texas at Austin, becoming the university’s first billion-dollar donors, according to an April 21 news release.
    • “The latest investment will support development of the UT Dell Campus for Advanced Research, anchored by an AI-focused UT Dell Medical Center expected to open in 2030. The Dells’ investment will also support expanded supercomputing capabilities, student scholarships and housing.
    • “The medical center will integrate Houston-based University of Texas MD Anderson Cancer Center to provide cancer care as part of the new campus.
    • “The university plans to break ground on the medical center later in 2026.”
  • Fierce Pharma points out,
    • “After AbbVie earlier this year pledged a whopping $100 billion in U.S. R&D and capital investments over the next decade, the company is filling in more details on its expansion plans. And like with many other pharma giants, it’s putting down roots in North Carolina.
    • “The North Chicago-based drugmaker on Wednesday revealed its largest-ever capital investment in a single campus, plotting a 185-acre production hub in Durham. The project will cost some $1.4 billion and add more than 730 roles to the company’s headcount, according to an April 22 press release. The site will produce certain AbbVie medicines in its immunology, neuroscience and oncology portfolios.”

Leave a Reply

Your email address will not be published. Required fields are marked *