From Washington, DC
- The House of Representatives today passed the Department of Homeland Security Appropriations Act, 2026 (HR 7744) by a 221 to 209 vote. The Senate will now consider this bill, the lack of which created the ongoing DHS shutdown.
- Per a Senate news release,
- “U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, delivered remarks during today’s hearing on how the U.S. Office of National Coordinator for Health Information Technology (ONC) is improving health outcomes using patient health information.
- “Click here to watch the full hearing.”
- Govexec reports,
- “The Trump administration will continue working to shrink the size of the federal workforce after already shedding more than 300,000 employees, a White House official said on Thursday, who suggested a leaner civil service will be more effective as a result of its reduced stability.
- “Continuing to reduce the size of the federal government and its workforce remains “priority number one,” Office of Management and Budget Deputy Director for Management Eric Ueland said at a government efficiency conference in Washington, adding it would contribute to the goal of tackling waste, fraud and abuse. He pledged that individual agencies would ensure consistent and transparent communication on their plans, so employees would at least have a clear roadmap of what is to come even if they disagree with the destination.” * * *
- “Scott Kupor, the Office of Personnel Management [OPM] Director who also spoke at the panel, said his agency is not giving agencies any specific targets for workforce reduction.” * * *
- “He added the needs of government will continue to grow, but agencies must find ways to add to their portfolios without adding staff.”
- Per an OPM news release,
- “The US Office of Personnel Management (OPM) today announced the launch of the Attorney Talent Network.
- “The Attorney Talent Network enables attorneys from across the United States to connect directly with federal recruiters and explore career opportunities in the federal government. By joining the network, attorneys can make their resumes searchable, receive notifications about job openings, and be alerted to upcoming hiring events.” * * *
- “Attorneys interested in joining can create or log in to their USAJOBS account, upload their resume, and opt in to share their profile with federal recruiters through the here.
- “For more information or to join the Attorney Talent Network, click here.”
- The American Hospital Association News tells us,
- “The Departments of Health and Human Services and Education March 5 announced a new initiative to increase nutrition education in medical schools beginning this fall for the next academic year. The agencies announced commitments from 53 schools for the program, which will provide at least 40 hours of nutrition education or a 40-hour competency equivalent for medical students. HHS also announced $5 million in funding for a multi-phase education challenge by the National Institutes of Health to support medical schools, nursing residency, nutrition science and dietitian programs that integrate nutrition education into their curricula. Additionally, HHS said that Public Health Service officers will be required to complete nutrition-focused continuing education hours as part of their career development.”
- Newfront offers RxDC reporting considerations for 2026 filings.
- Per an AHIP news release,
- “A new national survey finds American workers hold consistently positive views of employer-provided health care coverage, with nearly nine in 10 expressing satisfaction with their plans and strong majorities valuing the financial security and peace of mind their coverage provides.
- “Employer-provided coverage is the backbone of our nation’s health care system, delivering high-quality, affordable health care and financial security to more than 180 million Americans. These findings confirm once again that Americans strongly value their employer-provided health coverage and want policymakers to support the longstanding partnership between employers and health plans,” said AHIP president and CEO Mike Tuffin.
- Modern Healthcare points out,
- “A health insurance industry-backed coalition is going after hospitals in a bid to capitalize on Washington’s bipartisan focus on affordability and rising healthcare costs.
- “Better Solutions for Healthcare launched its “Hospital Watch” campaign last month. The organization’s website links to news articles and data that are unflattering to the hospital sector. A banner on the home page reads, “Shining a Light on Corporate Hospital Systems’ Role in Driving America’s Healthcare Cost Crisis.”
- “The effort could prove well-timed. Over the past few years, Congress has focused on drug prices and pharmacy benefit managers — as has President Donald Trump — and on health insurance premiums and industry practices. Their attention may be shifting to providers.”
From the Food and Drug Administration front,
- The Wall Street Journal lets us know,
- “Federal health officials, facing criticism from lawmakers for recent rejections of rare-disease drugs, attacked an Amsterdam-based biotech company seeking approval of a Huntington’s disease treatment and accused it of lying.
- “The public criticism of Uniqure by officials at the Food and Drug Administration and Health and Human Services department was unusual for agencies that normally shy away from commenting on products still under consideration.
- “The attacks risk further angering members of Congress who have been pressing the Trump administration to be more open to approving rare-disease therapies, after FDA officials rejected or delayed some applications for approval of some new drugs.”
- STAT News explains,
- “Is it better to approve a drug with undetermined or debatable benefits that is later found not to be effective?
- “Or, is it better to reject or block a drug with undetermined or debatable benefits that is later found to be effective?
- “These are two fundamentally different regulatory philosophies. Peter Marks, the former FDA regulator of cell and gene therapies, was firmly in the “approve now” camp. He believed in maximal flexibility, one might even call it absolute permissiveness.
- “If there was a chance a treatment could help a patient with a rare disease, even if the data were equivocal, Marks was willing to approve it. Rejecting that drug and later learning that it was effective is a far worse outcome, in Marks’ view.
- “Vinay Prasad, Marks’ successor at the FDA, takes a maximalist approach in the other direction. He wants to approve drugs that work with certainty. The regulatory bar is high.
- “Uncertainty — anything outside the statistical fence — is a disqualifier. For Prasad, approving a drug without proven benefit is false hope. Approving a drug that later ends up being ineffective is the worst outcome.
- “Two regulators, two extreme regulatory philosophies, one replacing the other.
- “The rare disease community is suffering whiplash. Drugmakers are frustrated. Investors are sitting on their wallets.”
- Fierce Pharma reports,
- “Since discontinuing its two branded versions of asthma inhaler Flovent at the start of 2024, GSK has still produced “authorized generic” versions of the treatment, which are the same products with different labels distributed by another firm.
- “Now, true competition has finally arrived for GSK’s Flovent in the form of an FDA approval for Glenmark’s fluticasone propionate inhalation aerosol. The inhaled corticosteroid, which reduces inflammation in the lungs, is a maintenance treatment and can be used by patients ages 4 and older to prevent wheezing and shortness of breath.
- “As the first company to gain FDA approval for a Flovent generic, Glenmark receives 180 days of exclusivity before other makers of generics can enter the market. Glenmark will begin distributing fluticasone this month, the company said in a release.”
- Radiology Business reports,
- “The U.S. Food and Drug Administration has approved the first artificial intelligence-powered imaging device for breast cancer surgery.
- “Manufacturer Perimeter Medical Imaging announced the news on Tuesday after earning premarket approval for “Claire” (formerly the Perimeter OCT B-Series). The product also has received Breakthrough Device designation, with it designed to enhance surgeon’s ability to detect difficult-to-see cancers during surgery.
- “This could potentially reduce the need for repeat operations and save excess healthcare costs, the company contends.
- “Repeat breast cancer surgeries due to residual disease remain a significant clinical, health and economic burden,” Perimeter CEO Adrian Mendes said in a statement March 3. “Claire’s FDA approval marks a major milestone in breast cancer care, as we advance our goal of reducing repeat surgeries so that no patient has to be told ‘we didn’t get it all.’”
- “Mendes said the Dallas-based company plans to roll out the product nationwide in the coming weeks. Claire combines proprietary AI with wide-field OCT imaging, enabling high-res, real-time evaluation of excised tumor margins. The system purportedly can deliver 10 times higher resolution when compared to standard X-ray and ultrasound.”
- BioPharma Dive adds,
- “PepGen is in a holding pattern on its request to include U.S. patients in a Phase 2 trial of a muscle disorder treatment after the Food and Drug Administration put a partial halt on the study.
- “The agency did not raise any questions about the company’s data in patients with the condition known as myotonic dystrophy type 1, or DM1, instead focusing on previously submitted preclinical work, PepGen said Wednesday. Specifically, the FDA seems concerned about drops in blood pressure in a study of mice that have not been seen in humans, analysts wrote.
- “PepGen said it’s working with the FDA to address the concerns as quickly as possible. The company is continuing its Phase 2 work elsewhere and recently got permission to open the “Freedom2” studyto patients in New Zealand, Australia and South Korea.”
From the judicial front,
- Per a Justice Department news release,
- “Brad D. Schimel, United States Attorney for the Eastern District of Wisconsin, announced today that Kinex Medical Company, LLC, agreed to pay $6,925,000 to resolve allegations that it violated the False Claims Act by submitting false claims to Medicare, TRICARE, and other federal programs.
- “Based in Waukesha, Wisconsin, Kinex sells and distributes durable medical equipment, including knee, shoulder, and hip braces, to patients across the United States. After receiving information from a whistleblower, the United States investigated and alleged that the company submitted false claims to Medicare, TRICARE, the Federal Employees Health Benefits Program (FEHBP), and the Office of Workers Compensation Programs of the Department of Labor (OWCP).
- “Specifically, the United States alleged that from 2019 through 2024, Kinex provided patients covered by these programs with medical braces that the patients did not need and then billed Medicare, TRICARE, FEHBP, and OWCP as if the braces had been necessary. The United States also alleged that Kinex convinced the patients to accept the braces by waiving costs like patient co-pays and by giving the patients other equipment for free.
- “In addition to paying nearly $7 million to resolve the allegations concerning these false claims, Kinex also entered into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General (HHS-OIG), to ensure compliance with applicable regulations going forward.”
- Fierce Healthcare relates,
- “The Federal Trade Commission (FTC) may be nearing settlements with the remaining two pharmacy benefit managers involved in a lawsuit over insulin pricing.
- “In a court filing (PDF) posted this week, the agency disclosed that it is making “significant progress” in talks with both CVS Health’s Caremark and UnitedHealth Group’s Optum Rx on the heels of a broad settlement with Cigna’s Express Scripts.
- “In late January, the FTC suspended the administrative case against Express Scripts, indicating a settlement was in the works. That settlement was later confirmed Feb. 4, with the PBM agreeing to a slew of changes to resolve allegations that it unlawfully and artificially inflated the price of insulin.
- “In the filing, the agency pushed back the date for an evidentiary hearing and oral arguments in the case by 21 days, to late March, to allow for greater negotiation time.”
From the public health and medical / Rx research front,
- MedPage Today reports,
- “Initiation of a GLP-1 receptor agonist was tied to lower risks of several substance use disorders (SUDs) in adults with type 2 diabetes, according to a target trial emulation using data on veterans.
- “In patients without a history of any SUD, those who started a GLP-1 drug versus an SGLT2 inhibitor had a reduced risk of a composite outcome of all SUDs, including alcohol, cannabis, cocaine, nicotine, opioid, and other SUDs (HR 0.86, 95% CI 0.83-0.88), reported Ziyad Al-Aly, MD, of the VA Saint Louis Health Care System, and colleagues.
- “Benefits also extended to those with pre-existing SUDs, the researchers wrote in The BMJ.”
- The AAMC shares information about
- GLP-1 pills for weight loss are here. How will they change obesity care?
- and
- What you need to know about the updated childhood vaccination schedule.
- Cardiovascular Business informs us,
- “A new implantable artificial intelligence (AI) device that modulates venous pressure to increase renal perfusion in diuretic-resistant heart failure patients was associated with positive 90-day data in the first-in-human RELIEF-FIH study. Researchers presented the data at the THT 2026 conference in Boston.
- “The Relief System from Relief Cardiovascular is a first-of-its-kind device. The goal of the device is to better manage heart failure congestion at home. It is one of many new heart failure technologies aimed at finding new ways to reduce heart failure rehospitalizations, which are a major driver for healthcare costs.
- “The Relief System incorporates a valve and sensor implant that uses AI to intelligently modulate venous pressure using hemodynamic data. The system actively adjusts flow in the inferior vena cava (IVC), which lowers venous pressure to drive durable decongestion in heart failure. It uses a daily transmission of hemodynamic data to adjust the valve through a cloud-enabled interface.”
From the U.S. healthcare business and artificial intelligence front,
- Beckers Payer Issues reports,
- “Excellus BlueCross BlueShield ended 2025 with a 1.4% operating loss totaling $108 million, as medical and drug claims climbed 16% year over year to nearly $7 billion. The insurer said March 5 the results are its largest annual claims increase in nearly 20 years.
- “Last year, Excellus spent roughly $19 million daily on medical and drug benefits for its 1.5 million members. The company’s 2025 medical loss ratio was 92%, and it recorded a 2% net margin and $150 million in net income. Reserves closed the year at $1.7 billion, which is equal to less than three months of claims and operating expenses.
- “Medicare Advantage drove most of the cost increase.”
- and
- “Three of four Regence health plans ended 2025 with operating losses as medical and drug costs climbed across Oregon, Washington, Idaho and Utah, according to results published by the organizations on March 2.
- “The Washington plan was the hardest hit. Regence BlueShield reported an operating loss of nearly 8% on total revenue of $2.38 billion and a net loss of 3.1%. The plan paid $2.17 billion in care for its fully insured members, with per-member costs rising more than 15% year over year. Total membership at the end of 2025 was 1.58 million.
- “In Oregon, Regence BCBS posted a 1.3% operating loss on revenue of $3.18 billion, though investment returns pushed the plan to 1.5% net income. The plan paid $2.9 billion in care for fully insured members, at $6,022 per member, up 15% from 2024. Total membership was roughly 950,000 at the end of 2025.
- ‘Regence BlueShield of Idaho also ran an operating loss, at 0.5% on revenue of $752 million, but finished with net income of 2.5% because of the strength of investment returns. Per-member costs rose more than 22%, the steepest increase among the four plans. The plan had more than 350,000 members at year’s end.
- “Regence BCBS of Utah reported net income of 3.5% on total revenue of $1.45 billion, slightly above its 10-year average of 3%, driven by strong member retention and investment income. The plan paid $1.31 billion in care for fully insured members, with per-member costs rising nearly 5%. Membership held at roughly 740,000.”
- The Commonwealth Fund tells us,
- “Changing how we pay for primary care can incentivize clinicians to deliver the right care at the right time. Historically, clinicians have been retroactively paid a fee for each service they provide. Known as fee-for-service (FFS), this practice encourages clinicians to provide more services, rather than efficiently deliver comprehensive care. Although it can lead to more care, it may not lead to better health outcomes.
- “Instead, we could use payment to encourage primary care clinicians to deliver appropriate, efficient care in coordination with other clinicians. An increasingly common way to do this — value-based payment (VBP) — ties clinicians’ payments to their performance on outcomes, including the cost and quality of care. Specific outcomes include the way clinicians manage patients’ chronic conditions or the minimization of avoidable hospitalizations. The evidence shows that changing how we pay for primary can improve patients’ outcomes, including reducing avoidable hospitalizationsand increasing access to coordinated care.
- “Despite the promise of VBP, some primary care practices have been left behind, and their patients haven’t been able to benefit. Policymakers and payers are particularly worried about low participation among rural, small, and independent practices, as well as community health centers (CHCs) that face unique barriers to participation.
- “In this blog post, we assess current rates of primary care physician (PCP) participation in VBP, using data from the 2025 Commonwealth Fund International Health Policy Survey of Primary Care Physicians. We also highlight opportunities to design value-based models to account for the needs of different practice settings, such as small or rural practices.”
- STATNews relates,
- “Digital chronic care company Omada reported a quarterly profit for the first time since going public less than a year ago, the company revealed while announcing its full year 2025 earnings Thursday.
- “Omada also provided earnings guidance for 2026, suggesting the company will continue to grow as it capitalizes on the demand for popular GLP-1 obesity medications.
- ‘Omada earned $260 million in revenue in 2025, 53% more than the year before — above top-end preliminary results the company announced at the J.P. Morgan Healthcare Conference in January. In August, shortly after it went public, it projected top-end earnings of $241 million for the year.
- “Notably, the company reported $5 million in net income in the fourth quarter of 2025 — the first time the company has turned a net profit.
- “We’re pretty ahead of schedule on a lot of positive financials,” Omada CEO Sean Duffy told STAT.”
- Modern Healthcare tells us,
- “CVS Health plans to launch a health technology subsidiary later this year that will offer an artificial intelligence-based platform designed to help consumers access healthcare information and services.
- “The platform will allow patients to find providers, compare costs of care and centralize their health records and information, CVS said. It also will make recommendations for the next steps of care for patients with chronic conditions and offer care management through a digital health portal between visits.
- “The Health100 consumer platform, slated to launch midyear, will use agentic AI and be powered by Google Cloud technology, including Gemini AI programs.
- “It will be rolled out first to CVS Health customers and not all features will be available upon launch, a spokesperson said. It will be expanded to other consumers, and outside providers and other companies can opt in to participate, the spokesperson said.”
- Healthcare Dive adds,
- “Amazon Web Services rolled out a suite of agentic artificial intelligence tools Thursday that aim to handle a range of healthcare tasks, like helping patients schedule appointments and summarizing medical data for clinicians. The product, called Amazon Connect Health, includes five capabilities: verifying patients’ identities; handling appointment scheduling; creating summaries of patient medical histories; creating clinical notes based on conversations between clinicians and patients; and generating medical codes from clinical documentation.
- “Amazon Connect Health should help patients more easily access care and assist with clinicians’ administrative work, according to Naji Shafi, general manager and director of healthcare AI at AWS. “Our healthcare workers are overburdened, drowning in administrative complexity, and it’s costing everyone,” he said.”
- Per Beckers Health IT,
- “Optum is expanding its collaboration with Microsoft to introduce new AI-powered capabilities within Optum Real, a real-time claims platform designed to connect payers and providers and streamline reimbursement workflows.
- “In a March 5 news release, the companies said the new capabilities combine Optum’s healthcare data and analytics expertise with Microsoft technologies including Azure, Dragon Copilot and Microsoft Foundry. The platform aims to give providers a unified view of clinical and operational data while helping teams identify coverage issues, automate documentation tasks and address prior authorization requirements earlier in the care process.”
- Fierce Healthcare informs us,
- “Eli Lilly has officially launched Employer Connect, its direct-to-employer platform for its obesity medications, after teasing the rollout late last year.
- “The drugmaker said in an announcement that the program is aimed at supporting employer choice and enabling them to build the solution that works best for them and their workforces. It will launch with more than 15 independent program administrators as partners, which allows employers to select multiple models.
- “Coverage for GLP-1s remains a key challenge for employers to navigate, as there is significant demand for the drugs that often come at a high cost. Within the program, Lilly will offer Zepbound KwikPen to network pharmacies at a discounted $449 price.
- “What the patient ultimately pays could vary based on the employer’s cost sharing model and which partner they lean on, per the announcement.”
- Fierce Pharma points out,
- “Galderma has significantly raised its peak annual sales estimate for Nemluvio (nemolizumab) to more than $4 billion, doubling its previous projection of more than $2 billion. The update follows what CEO Flemming Ørnskov described as an “outstanding launch trajectory” for the inflammatory skin condition drug in its first full year on the market.
- “Driven by strong adoption in its existing indications of atopic dermatitis and prurigo nodularis (PN), Nemluvio posted $452 million in 2025 sales. Growth accelerated sharply in the second half of the year, with the period contributing $321 million to the total. It comes as real-world experience with the IL-31 receptor inhibitor exceeded initial expectations, Ørnskov said on Galderma’s fourth-quarter earnings call Thursday.”
- and
- “After delivering solid sales growth in a difficult 2025, Germany’s Merck KGaA may have a tougher go of things this year, which the company is crediting in part to a predicted onslaught of U.S. generics to its multiple sclerosis blockbuster Mavenclad.
- Approved by the FDA in 2019, Mavenclad delivered its third straight year of blockbuster sales in 2025, charting nearly 17% growth over the previous year to 1.2 billion euros ($1.4 billion) worldwide, Merck KGaA reported Thursday. In North America specifically, the drug reeled in 635 million euros ($735 million) last year, Merck noted in a detailed earnings report issued(PDF) March 5.” * * *
- “[I]n an unfortunate turn for Merck, recent efforts to stave off Mavenclad patent challenges in the U.S. have fallen short, prompting the drugmaker to more or less throw in the towel on future growth for the MS med stateside.
- “In particular, Merck’s guidance for the year—anticipating sales between 20 billion euros and 21 billion euros, or -1% to 2% growth— “assumes no U.S. sales of Mavenclad from March 2026 amid generic competition.”
