From Washington, DC,
- Fierce Healthcare reports,
- “A prominent physician voice in the House of Representatives has introduced a new bill that would compel insurers to apply the cost for drugs purchased from direct-to-consumer platforms to deductibles and out-of-pocket maximums.
- “North Carolina Republican Greg Murphy, M.D., on Tuesday unveiled the Every Dollar Counts Act, a bill that aims to lower patients’ out-of-pocket costs for pharmaceuticals. Murphy, a consistent critic of insurers and pharmacy benefit managers, notes in an announcement that consumers have increasingly embraced DTC offerings as costs rise.
- “Using these platforms, patients can often find prices that cost far less out-of-pocket, especially for branded drugs, per Murphy’s office.”
- The American Hospital Association News adds,
- “The AHA and dozens of other organizations April 14 sent a letter of support to Reps. Suzan DelBene, D-Wash., and Mike Kelly, R-Pa., for their introduction of the Chronic Care Management Improvement Act. The bill would waive beneficiary cost-sharing requirements for Medicare beneficiaries receiving chronic care management services. Beneficiaries are currently required to pay a 20% coinsurance fee to receive such services. “This cost-sharing requirement creates a barrier to care, as beneficiaries are being billed for services that do not always include interfacing with their provider, thus creating confusion for patients,” the organizations wrote. “Also, many of these beneficiaries consider any additional out-of-pocket expense for healthcare services untenable.”
- “The AHA and dozens of other organizations April 14 sent a letter of support to Reps. Suzan DelBene, D-Wash., and Mike Kelly, R-Pa., for their introduction of the Chronic Care Management Improvement Act. The bill would waive beneficiary cost-sharing requirements for Medicare beneficiaries receiving chronic care management services. Beneficiaries are currently required to pay a 20% coinsurance fee to receive such services. “This cost-sharing requirement creates a barrier to care, as beneficiaries are being billed for services that do not always include interfacing with their provider, thus creating confusion for patients,” the organizations wrote. “Also, many of these beneficiaries consider any additional out-of-pocket expense for healthcare services untenable.”
- CMS has posted MMSEA Section 111 GHP User Guide Version 7.8 – April 13, 2026 (PDF)
- “The GHP User Guide * * * is your primary source for Section 111 GHP reporting requirements.”
- OPM Director Scott Kupor has added a new post titled “Merit Matters” to his Secrets of OPM blog.
- “If we want the best talent in the federal government – which I think we do – we should not refuse to hire college dropouts, unless dropping out of college is somehow representative of their ability to work successfully on behalf of the American people. And, if they are in fact world-class engineers, then we should pay them at the level at which they are performing versus force-fitting them into a lower pay level because they have no prior work experience.
- “Once again, merit matters.”
- Per an OPM news release,
- “US Office of Personnel Management (OPM) Director Scott Kupor joined Fox News’ Saturday in America with host Kayleigh McEnany to highlight the launch of EarlyCareers.gov, a new initiative to recruit more early career Americans into federal service and strengthen the government’s talent pipeline.”
From the Food and Drug Administration front,
- Fierce Pharma reports,
- “Even as Eli Lilly gets underway with its next major obesity launch in Foundayo, an FDA document related to the oral treatment shows lingering reservations about multiple “unexpected serious” risks potentially related to the drug.
- “In the FDA’s approval letter (PDF) for GLP-1 pill Foundayo, the agency tasks Eli Lilly with obtaining more information about the med’s potential link to major adverse cardiovascular events and drug-induced liver injury. In addition, the agency wants to gain more info about delayed gastric emptying associated with the drug and its potential effects in lactating women.
- “In its assessment of the medicine’s data, the FDA “determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a signal of a serious risk of retained gastric contents and to identify an unexpected serious risk for major adverse cardiovascular events (MACE), drug-induced liver injury (DILI), and exposure to [Foundayo] during lactation,” the letter says.”
- STAT News adds,
- “In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines.
- “FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded.
- “In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, and this inhibits greater understanding of how medicines might work. They also contend this can adversely affect treatment decisions and health care costs.”
- MedTech Dive relates,
- “Medline is removing certain angiographic syringes from the market due to problems with the devices becoming loose or disconnected.
- “Medline began the recall in February, and it was posted to the Food and Drug Administration’s website last week. The problem was the subject of a warning letter that Medline received in March, also recently posted to the FDA’s website.”
- Per an FDA news release,
- “The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies. When finalized, this guidance will provide recommendations for standardized methods for comprehensively assessing the safety of genome editing therapies to bring effective treatments to patients sooner.
- “Genome editing holds extraordinary promise for treating previously incurable genetic diseases, and today’s announcement represents the FDA’s forward approach to drive innovation and advance the development of genome editing therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This guidance provides sponsors with clear, scientifically-grounded recommendations for evaluating off-target editing risks using state-of-the-art sequencing technologies. We are serious about moving this ball forward.”
- “The draft guidance, issued by the Center for Biologics Evaluation and Research, supports the FDA’s framework for accelerating development of individualized therapies for ultra-rare diseases launched in February. The framework revolutionizes how the FDA engages with industry and promotes a path for transformative rare disease treatments.
- “The “Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing” guidance provides specific recommendations on sequencing strategies, sample selection, analysis parameters, and reporting.”
From the judicial front,
- Healthcare Dive reports,
- “A federal [magistrate] judge has tossed an Elevance subsidiary’s lawsuit against billing intermediary HaloMD and several California-based providers alleging they’re abusing the out-of-network billing dispute process set up by the No Surprises Act.
- “[Magistrate] Judge Karen Scott of the Central District of California dismissed the suit on Monday, finding that Anthem Blue Cross, Elevance’s California subsidiary, failed to prove that the companies were gaming the law’s independent dispute resolution, or IDR, in order to inflate their reimbursement.
- “It’s a major win for HaloMD, which is facing similar lawsuits from Elevance in three other states and has found itself in hot water over its status as the No. 1 submitter of IDR disputes. The Texas-based company cheered the court’s decision, while Elevance said it plans to appeal.”
- Yesterday, Anthem Blue Cross did appeal the court’s decision to the U.S. Court of Appeals for the Ninth Circuit.
- Bloomberg Law reports,
- “A Delaware judge threw out lawsuits seeking to link the heartburn drug Zantac to cancer, freeing makers of the product from facing trials in the state over the cases.
- “Superior Court Judge Francis “Pete” Jones concluded Monday lawyers for ex-Zantac users couldn’t produce legitimate evidence backing up claims the over-the-counter product caused cancer. Zantac is currently made by French drugmaker Sanofi.” * * *
- Because former Zantac owners GSK Plc, Pfizer Inc., Sanofi and Boehringer Ingelheim Pharmaceuticals already have settled thousands of Zantac suits over the last several years, it’s unclear how many Delaware cases will be dismissed by Jones’ order. GSK paid more than $2 billion in 2024 to resolve what it said was more than 90% of its pending cases.
From the public health and medical / Rx research front,
- Fierce Healthcare reports,
- “Seven in 10 U.S. adults gamble, according to a survey from the National Council on Problem Gambling (NCPG). Commercial gaming revenue broke records at $78.7 billion in 2025, with over $18 billion in tax revenue going into state and local coffers. All gaming segments, from casinos to sports betting to online games (iGaming), are growing. Throw in prediction markets, which allow users to speculate on the outcome of real-world events but are not legally considered gambling platforms, and the betting buffet becomes basically limitless.
- “This menu of options is creating an addiction crisis yet to be widely recognized by the public, policymakers and the healthcare sector, experts caution. Current national problem gambling prevalence is unknown due to a lack of research and funding dedicated to the issue. States that measure and publish their own prevalence rates see anywhere from 1% to 6%. Those most at risk include young adults, men and online gamblers. Gambling-related harms can be dire, from financial stress to co-occurring behavioral health conditions to suicide, which a fifth of individuals with gambling addiction attempt.
- “To understand problem gambling, what’s driving it and efforts underway to address it, Fierce Healthcare talked to two dozen providers, researchers, advocates and regulators. This story is also based on a review of research, as well as exclusive data from Komodo Health analyzed on Fierce Healthcare’s behalf.
- “It’s a small but mighty group of us that have been in this field, treating,” said Jody Bechtold, L.C.S.W., president of the International Problem Gambling and Gaming Certification Organization (IPGGC). “We call it the next opioid epidemic.”
- Healio tells us,
- “The risk for subsequent fractures is similar for older adults, regardless of whether they had an initial major osteoporotic fracture or nonmajor osteoporotic fracture, researchers reported.
- “In findings published in Journal of Bone and Mineral Research, researchers found that sustaining a major or nonmajor osteoporotic fracture raises the risk for subsequent fractures and mortality.”
- Infectious Disease Advisor informs us,
- “Rhinovirus and enterovirus are associated with severe clinical outcomes among hospitalized patients, including mechanical ventilation and death, highlighting the need for expanded respiratory virus surveillance among high-risk patient populations.”
- “Rhinovirus and enterovirus are associated with severe clinical outcomes among hospitalized patients, including mechanical ventilation and death, highlighting the need for expanded respiratory virus surveillance among high-risk patient populations.”
- MedPage Today points out,
- “A dual deprescribing intervention for proton pump inhibitors (PPIs) targeting patients and their primary care doctors proved effective in reducing potentially inappropriate use, a cluster-randomized trial in France found.
- “At 1 year, the combined approach — where patients got educational material about reducing PPI use mailed to them and their physicians received a letter detailing a deprescribing algorithm — resulted in twice as many patients cutting their PPI use in half (14.9%) versus usual care (7%) or physician-targeted intervention alone (7.7%, P<0.001 for both).
- “The results underscore “the value of prioritizing patient-facing deprescribing strategies,” wrote researchers led by Jean-Pascal Fournier, MD, PhD, of Nantes Université in France, in JAMA Internal Medicineopens in a new tab or window. Furthermore, the interventions were not associated with a resurgence in gastroesophageal reflux disease (GERD) symptoms.
- “PPIs in the U.S. are frequently prescribed for inappropriate indications and sometimes prescribed indefinitely, according to Fournier and colleagues.” * * * Potentially unnecessary PPI spending — reimbursements in 2015 hit $12 billion in the U.S.
From the U.S. heathcare business and artificial intelligence front,
- Modern Healthcare reports,
- “The Purchaser Business Group on Health, which represents large companies, launched a project to combine federally required data with claims data culled from its biggest members to provide insight into costs and quality in employer-sponsored health plans.
- “This has the potential to supply employers with unprecedented access to healthcare pricing data that could help curb escalating employee health benefit costs, said Purchaser Business Group on Health President and CEO Elizabeth Mitchell.
- “There is employer demand for this information that is unmet in the market,” Mitchell said during a Purchaser Business Group on Health webinar on healthcare transparency in February.
- “The Purchaser Business Group on Health has found that normal market forces that should be expected to link prices to quality don’t function in healthcare. Prices often fluctuate wildly based more on the size and market power of health systems or insurers than on the quality of services rendered.
- “For instance, its data reveal prices at hospitals in the same markets do not correlate with scores from the Leapfrog Group, which assesses hospital quality and safety. Often, low-rated hospitals charge more. Or the same hospital charges vastly different prices for the same procedures depending on the insurance plans, not any differences in the service.”
- and
- “Health systems are increasing their investments in concierge medicine to meet patient demand and keep burned-out doctors practicing.
- “Though typically a small percentage of a health system’s operations, concierge medicine — where patients pay thousands of dollars in membership fees for increased access to primary care physicians — helps diversify revenue and creates growth opportunities in new and existing markets.
- “Still, it’s a controversial model that raises questions about equal access to care because it historically has appealed to wealthier, often older individuals looking for more personalized primary care. Health systems say patient demand has expanded beyond that demographic.”
- Fierce Healthcare relates,
- “Anthem and Mount Sinai have reached a new multi-year contract agreement, restoring coverage for thousands after the system went out-of-network last month.
- “Anthem Blue Cross and Blue Shield of New York said in a statement Monday that the three-year deal returns Mount Sinai’s hospitals, physicians and other providers to its network. The health plan said that the contract “reflects both organizations’ commitment to delivering quality care while helping control healthcare costs for New York workers, families, employers and taxpayers.”
- “The contract also includes updated reimbursement models that aim to reward quality and outcomes, while continuing to support accurate billing and payment.”
- The Wall Street Journal lets us know ,
- Healthcare giant Johnson & Johnson JNJ reported nearly 10% revenue growth for the latest quarter on strong cancer drug sales that offset a steep decline from one of its bestselling drugs, Stelara.
- J&J said its first-quarter sales rose to $24.06 billion, topping the mean estimate of $23.62 billion from analysts surveyed by FactSet. Adjusted quarterly earnings also beat Wall Street expectations.
- On the back of those results, the drug and medical-device maker boosted its full-year financial forecast. So far, disruptions from the war in Iran haven’t materially hurt J&J.
- “There’s a lot of macro uncertainty out there,” J&J Chief Financial Officer Joseph Wolk said in an interview. “We think the fact that we’re not only maintaining but raising” the forecast is a sign of the company’s strength, he added.
- J&J has been working to ensure consistent growth after losing patent protection for Stelara, a treatment for skin and digestive conditions. Competitors introduced lower-cost alternatives last year, leading to a 60% drop in first-quarter sales of the brand-name version of the drug.
- Strong sales of J&J cancer medications like multiple-myeloma treatment Darzalex helped make up for those declines. The company’s cancer-drug sales rose more than 22% for the quarter. J&J is in a stronger position than some of its peers, which face even bigger patent cliffs in coming years.
- BioPharma Dive tells us,
- “Eli Lilly is again turning to dealmaking to boost its oncology portfolio, reaching a deal Tuesday to acquire a biotechnology company, CrossBridge Bio, that’s developing newer types of targeted cancer medicines.
- “Lilly will pay up to $300 million in cash for CrossBridge, a Houston-based startup making antibody-drug conjugates for cancer. That total includes an unspecified upfront payout and subsequent payment tied to a development milestone, CrossBridge said in a statement.
- “The deal hands Lilly technological capabilities that have become increasingly desirable to major pharmaceutical firms. Antibody-drug conjugates, or ADCs, are now a pillar of cancer care, a method of precisely delivering a toxic blow to malignant cells. Over 20 ADCs are currently available to treat tumors of the breast, lung, bladder and more. Many are working their way into earlier treatment lines, in some cases supplanting decades-old chemotherapy approaches.”
- MobiHealth informs us,
- “New York-based virtual women’s health provider Maven Clinic announced a strategic collaboration with care concierge company Wellthy to combine clinical care and caregiving support for employees.
- “Maven Clinic is a digital reproductive health and family platform that offers fertility and family planning services, pregnancy and postpartum care, parenting and pediatric support, and menopause-related care.
- ‘Wellthy offers a care concierge service that connects employees with care teams to help them navigate the healthcare system, including finding in-home support, understanding benefits, accessing legal resources and obtaining financial assistance.
- “The company also offers Backup Care services to help employees find emergency care for family members, including daycares, on-site childcare facilities and other community-based programs.
- “The aim of Maven and Wellthy’s partnership is to help employees in the “sandwich generation, – those in the period of starting a family and caring for an older loved one – navigate the process from fertility, growing a family and overseeing eldercare.
- “This partnership is about building a system that reflects how people live, with clinical care and caregiving support together in one place. When technology makes that support intuitive, you don’t just improve outcomes – you make it possible for people to ask for help in the first place,” Kate Ryder, founder and CEO of Maven Clinic, said in a statement.”
- The Wall Street Journal informs us,
- “Novo Nordisk NOVO.B said it would work with ChatGPT maker OpenAI on how to leverage artificial intelligence to discover new drugs, the latest AI partnership in the medical field as healthcare companies seek to harness the technology to get ahead of the competition.
- “The Danish drugmaker said it would integrate OpenAI’s models across its operations to help its workforce analyze complex datasets and reduce the time it takes to move from research to delivering treatments to patients.
- “The group said the partnership would boost efficiency across manufacturing, distribution, the supply chain and corporate, with pilot programs initially launching in research and development, manufacturing and commercial operations ahead of a full AI integration by the end of the year.” * * *
- “Drugmakers are turning to AI companies and their increasingly powerful models to improve operations and cut repetitive tasks for employees, giving them more time to focus on R&D in a bet that advancements in the technology will help them identify promising new drugs and treatments.”
- Modern Healthcare adds,
- “Health systems and payers are making big investments in artificial intelligence to improve their operations by reducing administrative burden, beefing up clinical prediction capabilities and increasing access to care.
- “A case in point: This year alone, UnitedHealth Group is investing $1.6 billion into its AI efforts. Companies also are realigning executive roles by adding chief AI officers or adding AI responsibilities to C-suite executives overseeing data and innovation.” * * *
- “Mike Baker, chief operating officer, UnitedHealthcare
- “UnitedHealth Group, our parent, has embedded the use of AI across our business to simplify healthcare and improve how people access care, information and support. UnitedHealth Group is investing $1.6 billion this year with the aim of making experiences more personalized, reducing administrative friction for clinicians, increasing transparency around cost and coverage, and supporting better care decisions.”
