Midweek Update

Simplicity is a virtue.

Simplicity is not about doing less; it’s about focusing on what matters most. The future of performance management is about creating value with clarity & ease.”

From Washington, DC,

  • BioPharma Dive reports,
    • “A bipartisan House bill proposed Tuesday would require government screening of U.S. investments in Chinese biotechnology in the wake of two pharmaceutical deals potentially worth more than $10 billion each.
    • “Reps. John Moolenaar, R-Mich., chairman of the Select Committee on China, and Debbie Dingell, D-Mich., are sponsoring the bill, dubbed the Biotech Investment National Security Act. It would amend the COINS legislation passed last year to restrict investment in certain sensitive technologies, adding biotechnology to the list.
    • “Under the new bill, licensing deals, joint ventures and equity investments in China could be subject to both Treasury and Defense Department reviews. Moolenaar and Dingell focused on licensing deals involving technology and intellectual property and excluded agricultural biotechnology, industrial fermentation and basic academic research.”
  • Federal News Network relates
    • “Close to 8,000 career federal employees will be moved into a new employment category with limited job protections, after the Trump administration took the final step to make Schedule Policy/Career a reality.
    • ‘An executive order President Donald Trump signed Wednesday afternoon formalizes the long-expected federal employment classification and eliminates civil service protections for thousands of senior-level positions across government. The move is meant to boost workforce accountability, but has also drawn sharp criticism from federal unions, employee organizations and other stakeholders.
    • “Trump administration officials said the creation of Schedule Policy/Career aims to improve employee accountability and ensure the federal workforce is carrying out the president’s policy agenda. Officials also said it’s currently too difficult to remove federal employees for poor performance.
    • “It’s also about a restoration, in our mind, of the democratic process,” Office of Personnel Management Director Scott Kupor told reporters during a press call Wednesday. “What Schedule Policy/Career does is really nothing new. This is exactly the way the system worked for a very long time … In order to affect the policy priorities of the administration, we need to have people willing to and capable of carrying out those directives.” * * *
    • “The targeted 8,000 career federal positions for the new classification is far lower than OPM’s initial estimate that Schedule Policy/Career would cover about 50,000 positions. Some earlier estimates had also suggested as many as 200,000 positions could be converted.”
  • Govexec tells us,
    • “With one protest withdrawn and a second one denied, the Office of Personnel Management is now free to move forward with its plan to award a 10-year contract to modernize the government’s human resource systems.
    • “OPM released the final solicitation in October for the Federal HR 2.0 contract to modernize systems that cover 2 million employees across the government. The agency wants a single integrated platform that will be the infrastructure for a more data-driven federal HR ecosystem, according to solicitation documents.
    • “Bidders had to submit proposals by Oct. 31 and OPM followed a two-step process for evaluation. After step one, IBM Corp. and then Economic Systems Inc. filed their protests.
    • “IBM filed its protest on Feb. 25 but withdrew without explanation on April 3. Meanwhile, Economic Systems filed a protest on March 2. On Monday, the Government Accountability Office posted on its public docket that it had denied Economic Systems protest.
    • “OPM could not make an award while the protests were active, but it could continue to evaluate proposals. Now it can pick a winner with the protests out of the way.
    • ‘While no dollar value has been disclosed, the undertaking is massive.”
  • Kevin Moss, writing in Federal News Network, encourages federal employees to take a look at joining FEHB and PSHB high deductible plans that allow them to contribute to triple tax deductible health savings accounts.

From the Food and Drug Administration front,

  • U.S. News and World Report reports,
    • “Acting U.S. FDA Commissioner Kyle Diamantas met ⁠with ⁠rare disease groups on Wednesday, according to groups ⁠attending and a government official, as the new chief seeks to repair relations with a sector disappointed ​by his predecessor.
    • “Representatives for rare disease organizations including Friends of Cancer Research and the Foundation for Angelman Syndrome Therapeutics are pushing Diamantas for greater certainty and support ‌for treatments for small patient populations, the ‌groups said.
    • “The acting chief is seeking to steady operations and mend fences following Commissioner Marty Makary’s resignation last month. Makary had clashed with the White ⁠House over issues including ⁠vaping products.
    • “Jeff Allen, CEO of Friends of Cancer Research, in a phone interview with Reuters ​following the meeting, described it as a “breath of fresh air.”
  • MedTech Dive relates,
    • “Edwards Lifesciences said it has secured FDA approval for the first surgical valve replacement designed for patients with tricuspid valve disease.
    • “The approval introduces a surgical option for a long-underserved area of structural heart care, extending Edwards’ Resilia tissue technology to the tricuspid position, a spokesperson told MedTech Dive in an email. 
    • “Called Triformis Resilia, the valve has a flattened sewing ring shape that mirrors the native tricuspid valve’s annulus anatomy.”

From the judicial front,

  • STAT News reports,
    • ‘A fourth major health insurer is suing HaloMD over its use of the No Surprises Act’s arbitration process, arguing that the middleman deceived arbitrators by sending them a “sham letter” and misleading price data. 
    • “Highmark Health, a Pennsylvania-based Blue Cross Blue Shield licensee with over 7 million members, claims in a complaint filed June 1 in U.S. District Court in Western Pennsylvania that HaloMD and one of its clients, a neuromonitoring provider called Bromedicon, submitted more than 450 ineligible disputes with the company and won more than $3.9 million. Like the three Blue Cross plans before it, Highmark wants those awards tossed and its money returned.” * * *
    • “Other insurers have so far gotten chilly receptions to their suits. Judges in California and Texas have dismissed similar lawsuits against HaloMD and its provider clients, finding their allegations — that the company deliberately submitted ineligible disputes and won huge payouts anyway — didn’t warrant the court’s review. The rulings don’t bode well for Highmark or outstanding cases in Georgia and Ohio.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “Eating a diet high in ultraprocessed foods is associated with an increased risk of dementia, according to new research, adding to the growing list of health problems linked to foods such as packaged cookies, hot dogs and chips.
    • “In a study published Wednesday in the American Journal of Public Health, the group of people who reported eating the highest amount of ultraprocessed foods had a 58% higher risk of later developing dementia and a 46% increased risk of developing cognitive impairment than those who said they ate the least.” * * *
    • “Nutrition researchers generally define ultraprocessed foods as items containing ingredients that wouldn’t generally be found in a home kitchen, such as emulsifiers—used to improve the texture of food—and high-fructose corn syrup. 
    • “The new study found that diets high in minimally processed foods, such as fresh fruits, vegetables, whole grains, fish and unprocessed meats, were linked to a decreased risk of dementia and cognitive impairment. People who ate the most minimally processed foods had a 41% lower risk of dementia compared with those who ate the least.”
  • and
    • “New research suggests anesthesia may be closer to being in a coma than previously thought, not just a deep sleep.
    • “Researchers compared brain-wave data from anesthetized patients with those awake, asleep or in a coma.
    • “Understanding these brain patterns could help redesign anesthesia to resemble natural sleep, reducing postoperative issues, experts say.”
  • MedPage Today relates,
    • “Deaths of despair — fatalities from drugs, alcohol, and suicide — declined by 16% in 2024, according to a report from Trust for America’s Health.
  • and
    • “Weight loss is known to reduce the need for joint replacement surgery in overweight or obese people with knee osteoarthritis (OA), and glucagon-like peptide-1 (GLP-1) receptor agonists are an established way to lose weight.
    • “This study of health records demonstrated that use of GLP-1 drugs was associated with reduced arthroplasty rates, with longer exposure leading to correspondingly lower rates.
    • “Reasons for initiating GLP-1 drug therapy were not known, however, and weight loss was not tracked over time, so the mechanisms underlying the observed associations remain unknown.”
  • Gastroenterology Advisor tells us,
    • “A baseline colonoscopy among individuals aged 40 to 49 years is associated with a significantly reduced risk for colorectal cancer (CRC), especially for men aged 45 to 49 years, according to study results published in the American Journal of Gastroenterology.” * * *
    • “These findings provide large-scale observational evidence that the risk-reducing association of an early baseline evaluation becomes increasingly apparent over several years of follow-up,” the study authors stated.”
  • Health Day notes,
    • “Scientists may be one step closer to staging Alzheimer’s disease with a simple blood test.
    • “The test could offer a cheaper, less invasive alternative to brain scans and spinal taps now used to diagnose and determine the extent of disease.
    • “Researchers developed a model that uses just two forms of tau protein in the blood to track Alzheimer’s progression. They tried it on more than 1,000 patients, including people who were cognitively unimpaired, patients with mild cognitive impairment, patients with Alzheimer’s dementia and people with other neurodegenerative diseases.
    • “The result: Staging from the blood model closely matched the accuracy of PET brain scans.”
  • and
    • “Population-based screening for early-stage type 1 diabetes identifies most children who progress to clinical type 1 diabetes, with additional cases detected with repeat screening, according to a study published online May 21 in the Journal of the American Medical Association.”

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

  • Beckers Payer Issues reports,
    • “Cigna will stop covering GLP-1s for weight loss through its own employee health plan July 1, the company confirmed to Becker’s.
    • “We regularly review our health benefits to ensure they remain sustainable, accessible and aligned with the unique needs of our workforce. As availability has increased and new options have emerged, we’ve made the decision to end our plan’s coverage for GLP-1s for weight loss,” a company spokesperson said. “We remain committed to supporting our employees’ health through a range of weight-management programs and resources.”
    • “The change will not apply to those using GLP-1s for diabetes, the spokesperson said. It also will not apply to Cigna plans beyond its own, a spokesperson confirmed to Reuters, which first reported the development June 2. GLP-1 users for weight loss have until June 30 to obtain refills. 
    • ‘An internal document reviewed by Reuters said employees can pay for these drugs with cash directly through manufacturer websites or TrumpRx. However, that spending would not count toward deductibles. Cigna will continue to cover generic weight-loss drugs that predate GLP-1s, such as phentermine, diethylpropion, benzphetamine and phendimetrazine, according to Reuters.
    • “Cigna joins a wave of healthcare employers cutting back GLP-1 access for their workers as cost pressures mount.”
  • The Wall Street Journal provides “Five Takeaways From the WSJ’s Autism Billing-Abuse Investigation — Insurers’ fraud warnings, a nearly $1 million surprise therapy bill and the back story of a visit to the Brooklyn-based provider the Perfect Child.”
  • MedTech Dive relates,
    • “Medtronic ended its fiscal year on a high note, growing revenue by nearly double digits in its fiscal fourth quarter.
    • “The medtech company brought in $9.8 billion of revenue in the quarter, representing year-over-year growth of nearly 10%. The performance was better than expected, J.P. Morgan analyst Robbie Marcus said in a note to investors.
    • CEO Geoff Martha said Medtronic delivered its strongest annual top-line growth in 10 years.
    • “Through a dynamic macro environment, we have executed, and we’ve executed with discipline to deliver an excellent fiscal ’26 that will continue into fiscal ’27,” Martha told investors Wednesday morning.
    • “The performance was driven by solid sales for its cardiovascular unit and strong growth for businesses within the segment.”
  • The Wall Street Journal inform us,
    • Eli Lilly LLY signed a collaboration and licensing agreement worth up to $1.9 billion with Ascidian Therapeutics to research and develop kidney-disease treatments.
    • “Ascidian, a Boston-based biotechnology company, said Wednesday it granted Eli Lilly exclusive, target-specific rights to its RNA-exon-editing technology for undisclosed kidney-disease targets.
    • “The RNA-exon editors are capable of altering parts of genetic code to repair genetic instructions that cause disease.
    • “Ascidian said it will lead discovery and certain preclinical activities, while Eli Lilly will be responsible for other preclinical work, clinical development, manufacturing and commercialization.
    • “Ascidian is eligible to receive up to $1.9 billion, including an upfront payment, development and commercial milestone payments, and tiered royalties on commercial sales worldwide, it said.”
  • Fierce Healthcare tells us,
    • “Mayo Clinic plans to develop and deploy a frontier AI model specifically designed for healthcare in collaboration with Microsoft. 
    • “The strategic collaboration combines Mayo Clinic’s global healthcare expertise, de-identified clinical health data and longitudinal insights with Microsoft’s advanced AI, cloud engineering and tech capabilities, the companies announced Tuesday.
    • “The two organizations say they are developing a frontier AI model “capable of supporting the broadest scope of clinical reasoning and healthcare use cases,” according to a press release.
    • “The frontier AI model is designed to synthesize diverse clinical data to support earlier diagnoses, more personalized treatment decisions and better patient outcomes. The AI collaboration will make Mayo Clinic’s medical expertise and integrated model of care available to more people when and where they need it, the two organizations said.”
  • Beckers Hospital Review adds,
    • “Washington, D.C.-based Children’s National Hospital has introduced a pediatric AI innovation hub to translate the technology from concept to bedside use.
    • “The partnership with Blacksburg-based Virginia Tech will bring together pediatric clinicians, biomedical researchers and AI specialists to create advancements for what has been an underserved community thus far in the technology’s evolution.
    • “Children have historically been underrepresented in AI research despite having fundamentally different physiology, disease patterns and developmental needs,” said Marius George Linguraru, director of AI research at Children’s National, in a June 2 news release. “We have an opportunity to build pediatric AI the right way from the beginning by developing and validating these technologies specifically for children and within pediatric clinical settings.”
  • Fierce Pharma points out,
    • “Pharma solutions firm Cencora and Gilead Sciences have expanded their longstanding partnership, cutting a deal in which the distribution giant will support access to Gilead’s CAR-T cancer therapies Yescarta and Tecartus.
    • “The collaboration is designed to facilitate more efficient access to the blood cancer therapies, which were developed by Gilead’s CAR-T subsidiary Kite Pharma. 
    • “Under the agreement, Cencora will leverage its substantial distribution infrastructure to bolster cell therapy availability at an “increasing number” of authorized U.S. treatment centers, including health systems and community oncology practices, according to a June 2 release.” 
  • HR Dive lets us know,
    • “Workers over age 55 make up almost a quarter of the workforce (23.2%), according to a report from MyPerfectResume. Moreover, according to researchers, the growth of the older workforce outpaces the general workforce. Likewise, the share of workers over age 65 increased by more than 40%, according to the report.”

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