From Washington, DC

• FedScoop informs us,
  • “President Joe Biden on Saturday signed into law the Government Service Delivery Improvement Act, legislation that targets improving customer service interactions with the government.
  • “The bill (H.R. 5887) was first introduced by Reps. Ro Khanna, D-Calif., Byron Donalds, R-Fla., Barry Loudermilk, R-Ga., and William Timmons, R-S.C., in October 2023. Now as law, it requires the Office of Management and Budget to choose a senior official as a “Federal Government Service Delivery Lead” to coordinate government service delivery improvement within agencies. 
  • “That service delivery lead would also work with new agency-appointed senior officials, who must be named within a year of the bill’s enactment, to oversee their organizations’ delivery improvements.”

• Per an HHS press releases,
  • “Today, U.S. Department of Health and Human Services Secretary Xavier Becerra announced he would delegate the authority vested in the HHS under the Dr. Emmanuel Bilirakis and Honorable Jennifer Wexton National Plan to End Parkinson’s Act to the National Institutes of Health, with support from the HHS Office of the Assistant Secretary for Health.”
• and
  • “Today, the White House Initiative on Asian Americans, Native Hawaiians, and Pacific Islanders (WHIAANHPI) unveiled Rising Together, its final report to President Joe Biden. The report showcases how the Biden-Harris Administration has leveraged the full force of the federal government to make real the promise of America for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) communities. Read the full report at wh.gov/whiaanhpireport2025 – PDF“
• and
  • “Today, the U.S. Department of Health and Human Services (HHS) announced seven winners of the KidneyX Sustainability Prize, designed to incentivize development of solutions to reduce water or power usage during dialysis care.” * * *
  • “HHS congratulates the winners of the KidneyX Sustainability Prize, who will each receive an equal share of the $7.25 million prize purse:  
    • “Kuleana Technology Inc. Advancing Hemodialysis Sustainability: Dialysate Regeneration via Uremic Toxin Photo-Oxidation. “Kuleana Technology’s Dialysate Regeneration Module enables hemodialysis with just 2 liters of water per treatment, making dialysis portable and accessible while saving 300 billion liters of water per year worldwide.”
    • “Micro Nano Technologies Inc. Handheld Water-Free and Battery-Powered Renal Replacement System. “The proposed technology mimics kidney filtration, eliminating the need for water and operating on a laptop-sized battery for 8 hours, ensuring dialysis access during disasters without traditional infrastructure.”
    • “Particle4X. SMART-PD: Sustainable Home Dialysis Revolution. “SMART-PD is an advanced home dialysis system that produces sterile PD fluid from tap water, reclaims effluent, and employs AI-powered monitoring to enhance sustainability and patient safety.”
    • “Qidni Labs Inc. Qidni/D: A Novel Sorbent Platform for Dialysis. “The Qidni/D is a portable and nearly waterless hemodialysis system that can offer accessible and sustainable access to care anywhere.”
    • “Stephen Ash. Sorbent Regeneration of Dialysate with Improved Ammonium Capacity. “We have developed a sorbent with high capacity for NH4+ (from urea) and minimal binding of Ca++ and Mg++, which should make regeneration of dialysate simpler, smaller and more practical.”
    • “University of Minnesota. Decentralized Dialysis Fluid Production: Enhancing the Sustainability of Dialysis Care. “Our innovation enables decentralized production of peritoneal dialysis fluids, reducing dialysis energy and water consumption by 48% and 66%, respectively, increasing supply chain resilience, and improving patient outcomes worldwide.”
    • “Wearable Artificial Organs Inc. Green dialysis on batteries using only 300ml of water. “A 2 lb. miniaturized Wearable Artificial Kidney (WAK) powered by rechargeable batteries, continuously regenerates dialysate water and delivers continuous dialysis 24 hours a day, 7 days a week.”
  • Kudos to the prize winners.
    
• The American Hospital Association News tells us,
  • “The Centers for Medicare & Medicaid Services Jan. 8 announced 23.6 million consumers have signed up for a 2025 Health Insurance Marketplace plan. Of that total, approximately 3.2 million are new consumers. Open enrollment continues until Jan. 15 for the 31 states that use HealthCare.gov and most state-based marketplaces for coverage beginning Feb. 1.” 
    
• Kevin Moss, writing in Federal News Network, answers the question “If someone is on Federal Health Benefits, what happens when they turn 65 and become eligible for Medicare, and what happens when their spouse turns 65 and is also eligible for Medicare?” It’s worth adding that OPM regulations grant special FSHB/PSHB open enrollment period to employees and annuitants who turn 65:
  • On becoming eligible for Medicare. An employee [or an annuitant] may change the enrollment from one plan or option to another at any time beginning on the 30th day before becoming eligible for coverage under title XVIII of the Social Security Act (Medicare). A change of enrollment based on becoming eligible for Medicare may be made only once. 5 CFR Secs 890.301(k), 890.306(p)

• Stars and Stripes gives us an update on the “pilot program aimed at helping Department of Defense civilian employees [based in Japan] find health care from Japanese providers is up and running, according to the DOD. The program, which aims to connect the civilians with local health care providers without paying large, upfront service fees, among other advantages, began Jan. 1, according to a fact sheet emailed to employees Wednesday by the U.S. Army Civilian Human Resources Agency. The program complements existing health insurance coverage for eligible DOD employees.”

From the judicial front,

• Bloomberg Law reports,
  • “A trade group representing consumer credit reporting companies and a Texas-based credit union association sued to block the Consumer Financial Protection Bureau’s new rule barring most medical debt from credit reports.
  • “The CFPB overstepped its authority in eliminating medical debt from credit reports and banning creditors from considering medical debt in lending decisions, the Consumer Data Industry Association and the Cornerstone Credit Union League said in a complaint filed Tuesday in the US District Court for the Eastern District of Texas.
  • “Only Congress has the power to determine whether information can or can’t be included in credit reports, the complaint said.
  • “The ban will make it harder for lenders, employers, and rental housing providers to make informed decisions about the creditworthiness of borrowers, the industry groups said. 
  • “Knowing whether a consumer has debt is an important element of underwriting, and unilaterally eliminating consideration of coded medical debt information erodes the predictive nature, and therefore the value, of consumer reports,” the complaint said.
  • “The suit came on the same day the CFPB finalized its medical debt rule.”

From the Food and Drug Administration front,

• Fierce Pharma lets us know,
  • “The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning about the risk of developing Guillain-Barré syndrome (GBS), a rare neurological condition that can cause paralysis.
  • “The ruling will affect GSK’s Arexvy and Pfizer’s Abrysvo, both of which were approved by the agency in May of 2023 for adults 60 years or older and realized booming sales in their first year on the market.
  • “Seven months ago, however, the sales potential for both shots declined significantly when the Centers for Disease Control and Prevention (CDC) recommended that they only be used by adults aged 75 and older and those 60 and older who have a high risk of severe disease due to underlying medical conditions.
  • “In narrowing the population with its revised recommendation, the CDC cited the potential link between the vaccines and GBS.
  • “On Tuesday, the FDA explained that its new guidelines come after the agency conducted a post marketing observational study and evaluated the results of clinical trials and reports to its Vaccine Adverse Event Reporting System (VAERS).”

• Per Healthcare Dive,
  • “The Food and Drug Administration’s device center clarified how manufacturers should approach artificial intelligence in a draft guidance issued on Monday.
  • “The document outlines recommendations for design, development and maintenance to ensure AI-enabled devices are safe and effective. In particular, the guidance outlines how device makers should address transparency and bias and when post market monitoring is needed. 
  • “Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, said the agency has authorized more than 1,000 AI-enabled devices to date. 
  • “As we continue to see exciting developments in this field, it’s important to recognize that there are specific considerations unique to AI-enabled devices,” Tazbaz said in a statement.”

• Per MedTech Dive,
  • “Johnson & Johnson said Wednesday it paused all U.S. Varipulse caseswhile the company investigates the cause of four reported neurovascular events.
  • “J&J said the cases were part of an external evaluation in the U.S. The pause was initiated on Jan. 5. J&J completed more than 130 cases across 14 sites as of Jan. 3.
  • “An external evaluation is a limited rollout intended to collect physician feedback on a new technology before a full release, a J&J spokesperson said in an email to MedTech Dive.
  • “Because the evaluation used a unique platform configuration, the pause does not affect the rollout of Varipulse outside of the U.S., where more than 3,000 commercial cases have been completed, J&J said.
  • “The pause of U.S. cases comes two months after J&J received Food and Drug Administration approval for Varipulse, becoming the third device company to offer a PFA system in the U.S.”

From the public health and medical research front,

• The National Cancer Institute released its Cancer Information Highlights concerning “Targeted Therapy for Head and Neck Cancer & CAR T-Cell Therapy for Brain Cancer.”

• MedPage Today informs us,
  • A study of older adults showed that 6% had depression, with higher prevalences in certain groups, including women, those who were unmarried, and those with chronic medical conditions. (Journal of the American Geriatrics Society)
  • A single 25-mg dose of synthetic psilocybin significantly improved depressive symptoms by week 3 among participants with severe treatment resistance in a small single-arm open-label trial. (American Journal of Psychiatry)
  • Older adults with major depressive disorder displayed riskier driving compared with those without depression, according to a prospective longitudinal cohort study. (JAMA Network Open).

• MedPage Today adds, “Two types of Wicklow Gold cheddar cheese sold in five states were recalled due to potential contamination with Listeria monocytogenes, Abbey Specialty Foods said [last Friday].”

From the U.S. healthcare business front,

• Healthcare Dive expects that “Health insurers will step off the roller coaster in 2025. After a turbulent year, things should calm for payers with the advent of a business-friendly Trump administration — though challenges will persist.”

• MedCity News discusses
  • How Can Employers Manage Rising Healthcare Costs in 2025? Multiple reports indicate that employers can expect rising healthcare costs in 2025. To address these costs, employers are holding their vendor partners accountable and evaluating their health plan and PBM partners.
• and
  • “Biopharma in 2025: Outlook for Obesity Meds, Drug Prices, Regulation & More. Metabolic medicines dominated life sciences headlines in 2024, a trend expected to continue into the new year. Other things to look for include more widespread adoption of artificial intelligence technologies and the IPO market’s return to normal levels.”

• STAT News reports
  • “Next week brings the return of the J.P. Morgan Healthcare Conference, and with it another fabled opportunity for companies in the industry to court possible mergers, acquisitions, and licensing deals. This year, there will be even greater pressure to make a good match, as the pharmaceutical industry, which drives more than $1 trillion in economic activity and thousands of jobs, faces one of the largest patent cliffs in recent history. 
  • “Between now and 2033, the patents on dozens of brand-name medications will expire, allowing generic drugmakers to begin selling cheaper versions. Drug companies stand to lose more than $400 billion in revenue as patents expire for Keytruda, Eliquis, Jardiance, Opdivo, and other blockbuster therapies. (By comparison, the last major patent cliff that hit the industry, in 2011, jeopardized around $250 billion in drug revenue.) 
  • “One of the few tried-and-tested methods for navigating a patent cliff is to acquire startups and new drugs — and lots of them. As a result, many experts anticipate pharma ramping up M&A activity in 2025, starting at the J.P. Morgan conference. 
  • “We always have a handful of deals announced around JPM. But the real work is the meetings that happen at JPM, that start the discussions.… I think people need to buckle up, because it’s already twice as frothy and could get even more,” said Charles Ruck, an attorney at Latham Watkins who specializes in M&A.”

• Per Fierce Healthcare,
  • “Two-thirds of insured Americans say they would trust a health insurer’s artificial intelligence copilot to accurately inform them about a health plan’s benefits, a survey conducted by virtual care navigation platform Pager Health and market research firm The Harris Poll reveals.
  • “Of the respondents, 66% believe AI can correctly personalize digital healthcare with the goals and needs of the member. Even more respondents think AI can find doctors accepting new members and schedule appointments.
  • “The survey, shared exclusively with Fierce Healthcare, provide insights into how members want insurers to offer a better customer experience, sometimes through AI. However, health plans do not fully capitalize on this opportunity.
  • “Only 41% of people say they receive personalized messages, while 17% don’t receive health plan recommendations at all. About one-third of respondents say an insurer’s wellness programs would be more enticing if they received progress alerts, biometric information or claims data.
  • “Only health plans that fully leverage the power of AI to analyze the wealth of health data available will be able to meet this demand and, in the process, boost member engagement and satisfaction,” said Rita Sharma, chief product officer at Pager Health, in a news release.”

• The Wall Street Journal reports,
  • “Novo Nordisk expanded a deal with Valo Health, a U.S. company, to discover and develop treatments for obesity, type 2 diabetes and cardiovascular disease using human data and artificial intelligence.
  • “The deal extends an agreement signed in 2023 and will see Valo become eligible for increased payments and funding.
  • “Under the original deal, the companies agreed to develop up to 11 drug programs, primarily focused on cardiovascular disease, with Valo eligible to receive up to $2.7 billion in milestone payments, plus research and development funding and potential royalty payments.
  • “The new agreement set out Wednesday expands the scope to put a stronger focus on obesity and type 2 diabetes and includes near-term payments to Valo of up to $190 million.
  • “A further $4.6 billion in potential milestone payments will be made for up to nine new drug programs and Valo will also be eligible for more research and development funding and potential royalty payments.
  • “The companies will continue to use Valo’s drug discovery and development platform that uses patient data and AI to generate new insights and translate them into potential therapeutics.”

• Per Healthcare Dive,
  • “Transcarent, a healthcare platform for self-insured employers, will acquire benefits navigator Accolade for about $621 million, the companies announced Wednesday. 
  • “The deal will combine Transcarent’s offerings — including an artificial intelligence-backed information and navigation service, health benefits guidance and virtual care — with Accolade’s services, like providing virtual primary care and specialist consultations, as well as patient advocates and care navigation. 
  • “The acquisition will net Accolade stockholders $7.03 per share in cash, an approximately 110% premium over the company’s closing stock price on Tuesday. Transcarent’s CEO, noted entrepreneur and investor Glen Tullman, will head up the combined organization, according to a spokesperson.”