Blog | 3/6/2026

Sharp Strategy Spotlight: March 6, 2026

Strategic perspectives on the trends, policies, and ideas shaping healthcare.

NOTE: All words/analysis are those from the source noted, opinions are those of the original authors and not reflective of Health Advances in general nor any individual. All sources are non-confidential and in the public domain (but some may be behind paywalls).

This issue reflects news as of 11 AM on March 5, 2026. The details and broad themes may have changed.

KEY FEDERAL GOVERNMENT NEWS

HHS postpones third consecutive meeting of preventive health panel

  • The March ​meeting of the U.S. advisory panel that determines what cancer screenings and other preventive health measures insurers must cover ‌has been postponed, according to a spokesman for the U.S. Department of Health and Human Services.
  • The 16-member U.S. Preventive Services Task Force, which usually holds three annual meetings, last met in March of 2025. Its November 2025 meeting did not take place due to a government shutdown. The previous meeting, set for July 2025, ​was abruptly canceled by HHS.
  • "The first USPSTF meeting of this year has been postponed and will be rescheduled in the ​coming months," HHS spokesman Andrew Nixon said in an email on Tuesday. He did not provide a reason ⁠for the latest postponement.
  • Concern has circulated since last year that Health Secretary Robert F. Kennedy Jr. might disband the panel as part of ​an effort to reshape U.S. regulation of vaccines, food and medicine.
  • Last June, Kennedy fired all 17 members of the Centers for Disease Control and ​Prevention's Advisory Committee on Immunization Practices, a panel of vaccine experts, replacing them with seven handpicked members, including known vaccine skeptics.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/march-meeting-us-preventive-services-task-force-postponed-2026-03-03/

FDA to offer bonus payments to staffers who complete speedy drug reviews

  • The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete their work ahead of schedule, the latest in a flurry of changes to longstanding norms and procedures.
  • FDA Commissioner Marty Makary described the effort as a pilot program during a staff presentation Thursday, saying the first quarterly bonus payments would start going out to employees around August. The Associated Press obtained slides and a recording of the presentation.
  • “My job as your commissioner is to be your advocate and to fight for you,” Makary told FDA staffers, adding that getting approval for the payments took “some wrangling.”
  • “If you don’t like it, we can get rid of it, but usually everybody loves money,” Makary said.
  • The plan raises a number of questions, including exactly how the payments will be distributed across large teams of staffers who typically contribute to drug reviews. Employees who are not directly involved in drug reviews — such as factory inspectors — are not eligible for the payments. The pilot also presents potential ethical dilemmas if FDA reviewers are seen as being rewarded for rushing steps needed to confirm drug safety and effectiveness.
  • https://apnews.com/article/drugs-fda-review-bonus-payments-makary-af17b24723035e3e6e2eefdfea694808

RFK Jr. Adds Two New Members to CDC Vax Panel

  • HHS Secretary Robert F. Kennedy Jr. appointed two more physicians to the CDC's Advisory Committee on Immunization Practices (ACIP) ahead of its March meeting, including one with a history of criticizing vaccines.
  • An agency press release emphasized that Angelina Farella, MD, and Sean G. Downing, MD, both have experience in pediatrics. Farella has been particularly outspoken against COVID vaccines, which are on the agenda for the committee's March meeting.
  • As of press time, HHS had not responded to MedPage Today's questions about the selection criteria and process for adding these latest members or how ACIP will ensure its vaccine decisions are evidence-based, considering Farella's vocal opposition.
  • Federal vaccine advisors are set to review the COVID vaccine, long COVID, and "COVID-19 vaccine injuries" on March 18 and 19, according to the Federal Register. The meeting was originally supposed to be last month, but it was postponed.
  • https://www.medpagetoday.com/washington-watch/washington-watch/120129

Bhattacharya Pushes NIH-CDC Integration

State Medicaid budgets to lose $664B under OBBBA: Study

  • State Medicaid budgets will shrink by $664 billion through 2034 as key provisions of the One Big Beautiful Bill Act (H.R. 1) take effect, with impacts varying by state depending on expansion status, reliance on provider taxes and the use of state-directed payments, according to a RAND study published Feb. 26.
  • Meanwhile, Medicaid managed care insurers have been flagging a mismatch between state capitation rates and enrollee acuity over the last couple of years following the pandemic-era continuous enrollment unwinding. 
  • H.R. 1, signed into law on July 4, will impose work requirements on non-disabled Medicaid enrollees, increase the frequency of eligibility redeterminations, restrict eligibility for some immigrant groups, and tighten rules around provider taxes and state-directed payments.
  • Press: https://www.beckershospitalreview.com/finance/state-medicaid-budgets-to-lose-664b-under-obbba-study/
  • Study: https://www.rand.org/pubs/research_reports/RRA4098-1.html

HHS bans Claude AI tool as Trump seeks full government blacklisting of Anthropic

  • The Department of Health and Human Services (HHS) has told employees they can no longer use Claude, a generative artificial intelligence tool from Anthropic, as President Donald Trump seeks to blacklist the company from the federal government.
  • While Claude is now off-limits, similar tools like OpenAI’s ChatGPT Enterprise and Google Gemini “remain available for authorized mission-related use,” HHS spokesperson Emily Hilliard confirmed to Fierce Biotech.
  • The loss of Claude could hinder efforts at the FDA to hasten the drug review process, which has been marked by multiple delays during Trump’s second term. Last summer, the regulator rushed to launch an AI tool called Elsa a month ahead of schedule as part of a plan to speed up new product reviews.
  • Elsa was originally developed based on Claude, according to a report from Stat.
  • At the time of publication, Hilliard had not responded to questions from Fierce about how the banning of Claude will impact the FDA’s workflow.
  • https://www.fiercebiotech.com/ai-and-machine-learning/hhs-bans-anthropics-claude-ai-tool-trump-seeks-full-government-blacklisting

Doctors' Mistrust of Insurers Is Holding Up Instant Prior Authorization, Dr. Oz Says

  • Doctors' distrust of insurers is one reason instantaneous prior authorization hasn't happened yet, according to CMS Administrator Mehmet Oz, MD, MBA.
  • "When I ask insurance companies about why they don't accelerate prior authorization and do it instantaneously, the answer they give me -- and we've done this with all the big players -- is that doctors won't share data," Oz said here Tuesday at a conference sponsored by Accountable for Health, an advocacy group that promotes the adoption of accountable care programs. "Amazingly, they say that doctors will give paper responses because they don't trust the insurance companies to use the data appropriately."
  • "And so, although we're trying to accelerate and make the adjudication of prior authorization in real time, you can't do it if you're not exchanging information back and forth in real time," he said. "I think it's reflective of the kind of challenges that we're facing."
  • https://www.medpagetoday.com/publichealthpolicy/medicare/120146

Top FDA drug official is trying to hire a friend who’s seeking a bold new warning on antidepressants

  • The Food and Drug Administration’s top drug regulator, Dr. Tracy Beth Hoeg, is working to hire a researcher and friend who wants the agency to add new warnings to antidepressants about unproven pregnancy risks, The Associated Press has learned.
  • Dr. Adam Urato, a maternal-fetal medicine specialist and critic of antidepressant safety, is pressing the FDA to add a boxed warning to SSRIs, the drugs most commonly prescribed for depression. Urato’s petition says the medications can cause pregnancy complications, including miscarriages and fetal brain abnormalities that may lead to autism and other disorders in children.
  • Within the agency, Hoeg’s close relationship with Urato is viewed as a clear conflict of interest that, under normal FDA standards, would result in her recusing herself from any work on the petition. But Hoeg is actively working to speed up the agency’s review of her friend’s proposal, according to the people familiar with the situation.
  • https://apnews.com/article/hoeg-urato-fda-drugs-antidepressants-pregnancy-warnings-a2a48cd2285f5b33aef2d390b5b60d0c

Trump’s Medicaid work mandates are meant to save money. But first states will have to spend millions

  • To receive Medicaid health coverage, some adults will soon have to show they are working, volunteering or taking classes. But to gather that proof, many states first will have to spend millions of dollars improving their computer systems.
  • Across the nation, states face an immense task and high costs to prepare for the Jan. 1 kickoff of new Medicaid eligibility mandates affecting millions of lower-income adults in the government-funded health care program.
  • The first half of a $200 million federal allotment has already begun flowing to states to help implement the new requirements. But the tab for the needed technology improvements and additional staff is likely to exceed $1 billion, according to an Associated Press analysis of budget projections in more than 25 states. That extra cost will be borne by a mixture of federal and state tax dollars.
  • The task is not as simple as pushing through a software update on your smartphone or personal computer. That’s because each state has its own system for managing Medicaid, often requiring experts to make customized changes.
  • “Our current eligibility systems are pretty old, and the ability to change them is very, very difficult,” said Toi Wilde, chief information officer for the Missouri Department of Social Services.
  • https://apnews.com/article/medicaid-work-requirements-trump-baea2561c67b0d24eddacbeb77ce6ec3

FDA's top operating official Butler to retire, deputy to take over in April

  • Barclay Butler, deputy commissioner for operations and chief operating officer in the FDA’s office of operations, will retire in the coming months, according to an email to staff from FDA Commissioner Marty Makary that was reviewed by Endpoints News.
  • Butler’s deputy, Melanie Keller, will take over both of his roles on April 6, according to Makary’s email. She has spent the last two decades at the NIH and FDA.
  • An FDA spokesperson confirmed the change. According to the FDA’s website, Butler oversees “management of business programs and operations across the FDA enterprise level, including human resources and facilities.”
  • Butler took the dual operating roles last March after serving for a decade in the Defense Health Agency and in the Department of Defense.
  • https://endpoints.news/fdas-top-operating-official-butler-will-retire-deputy-will-take-over-in-april/   (subscription required for full text)

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

Minnesota sues to block Trump administration’s holding back of Medicaid funds

  • Minnesota on Monday sued President Donald Trump’s administration in an attempt to stop it from holding back $243 million in Medicaid spending, warning it may have to cut health care for low-income families if the funding is held back.
  • The lawsuit asked a U.S. court in Minneapolis to block federal health officials from “immediately withholding” the money, which funds the health care safety net for low-income Americans.
  • The move came after Vice President JD Vance said last week the administration would “temporarily halt” some Medicaid funding to Minnesota over fraud concerns, as part of what he described as an aggressive crackdown on misuse of public funds.
  • Minnesota already is appealing CMS withholding $2 billion in annual Medicaid funds announced in early January, said John Connolly, deputy commissioner and state Medicaid director for Minnesota’s Department of Human Services.
  • The lawsuit names the Department of Health and Human Services and the Centers for Medicare and Medicaid Services as well as Dr. Mehmet Oz, in his official capacity as CMS administrator, and Robert F. Kennedy Jr. in his official capacity as HHS secretary.
  • CMS said Tuesday it does not comment on litigation. CMS asked Minnesota in a letter last week for documentation for various issues, including $243 million related to 14 “high-risk” Medicaid service areas.
  • https://apnews.com/article/minnesota-medicaid-funding-lawsuit-trump-3242c0992c8c266570bfd3200b14b483

RFK Jr has 'unreviewable' authority to reshape vaccine policy, DOJ lawyer tells judge

  • A lawyer for the Trump administration told a judge on Wednesday that Health and Human Services Secretary Robert F. Kennedy Jr. has such broad authority over vaccine policy that he could even ​scrap recommendations for measles shots in favor of people deliberately exposing themselves to the virus.
  • U.S. Department of Justice lawyer Isaac Belfer offered that hypothetical ‌as he urged U.S. District Judge Brian Murphy in Boston to rule that Kennedy, a long-time vaccine skeptic, and other health officials have such unfettered authority that their vaccine decisions are not subject to court review.
  • Belfer said that authority should preclude a lawsuit by medical groups seeking to block a wide range of vaccine policy changes under Kennedy, including the U.S. Centers for Disease Control and Prevention’s January decision to cut the ​recommended number of shots for children.
  • "What they want this court to do is supervise vaccine policy indefinitely," Belfer said during the second day of arguments on the ​plaintiffs' request for a preliminary injunction.
  • Murphy, who was appointed by Democratic President Joe Biden, appeared skeptical he could not assess whether the U.S. ⁠Department of Health and Human Services and its agencies acted lawfully and complied with the Administrative Procedure Act as they revamped vaccine policy.
  • By law, ​Congress has directed the HHS secretary to assist states "in the prevention and suppression of communicable diseases and with respect to other public health matters" and advise on matters relating to the improvement of public health.
  • But Belfer argued those terms were ambiguous and that Kennedy, the CDC and the Advisory Committee on Immunization Practices have wide latitude to legally express their views as to what vaccine policy would promote the ​public health.
  • https://www.reuters.com/legal/government/rfk-jr-has-unreviewable-authority-reshape-vaccine-policy-doj-lawyer-tells-judge-2026-03-04/

KEY BIOPHARMA NEWS

FDA drafts guidance explaining 3-year clinical investigation exclusivity for new drugs

  • In a new draft guidance, the US Food and Drug Administration (FDA) has provided details on the clinical investigation requirements that sponsors of new drugs must meet to obtain three years of marketing exclusivity for their products.
  • On 4 March, FDA published a draft question-and-answer guidance to clarify requirements for receiving the drug marketing exclusivity.
  • In addition to stating what applications are eligible for the three-year exclusivity and whether sNDAs qualify as well, the agency explains that non-bioavailability studies may qualify as clinical investigations to support the drug marketing exclusivity, though it notes that the drug in the clinical investigation does not need to be the same as the drug that was approved for the application.
  • FDA also emphasized that trials that only administer a placebo to study participants would generally not be considered a clinical investigation that can be used for the purpose of obtaining marketing exclusivity.
  • The agency also explained what clinical trial information it expects applicants to provide in their NDA applications.
  • The FDA said that it considers a clinical investigation essential to the approval of a marketing authorization if it does not have enough information to decide whether the drug under review is safe and effective without it. The agency said it does not consider an investigation essential for approval just because the sponsor conducted and submitted it in its application or supplement.
  • Analysis: https://www.raps.org/news-and-articles/news-articles/2026/3/fda-drafts-guidance-explaining-3-year-clinical-inv
  • FDA draft guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/new-clinical-investigation-exclusivity-3-year-exclusivity-drug-products-questions-and-answers

CMS extends application deadline for new Medicaid drug pricing model

  • The White House said Monday afternoon that it will extend the deadline for drugmakers to apply for a new model that seeks to establish most-favored nation pricing in Medicaid.
  • The Centers for Medicare & Medicaid Services said that the application deadline for the new GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) model will be pushed back from March 31 to April 30 to allow pharmaceutical companies greater time to sign up.
  • State Medicaid programs that participate in GENEROUS will be able to purchase prices for drugs included in the pilot model at a price that's aligned to the price paid in other countries. The model was launched under an executive order from President Donald Trump focused on lowering drug prices.
  • CMS said it will begin meeting this week with manufacturers who have expressed interest in participating, and will hold a town hall for drugmakers later this spring.
  • The agency added that the final deadline for participation will remain June 30.
  • “Based on feedback from drug manufacturers, CMS has decided to give interested companies additional time to apply for the GENEROUS Model,” said CMS Administrator Mehmet Oz, M.D., in the press release. “We are committed to partnering with states and manufacturers to drive down drug prices and ensure that the most vulnerable Americans have access to life-saving medications.”
  • Press: https://www.fiercehealthcare.com/regulatory/cms-unveils-new-model-aims-bring-most-favored-nation-pricing-medicaid
  • CMS press: https://www.cms.gov/newsroom/press-releases/cms-lower-drug-costs-improve-care-extending-deadline-generous-model-application

FDA issues long-awaited final NDC rule

  • The US Food and Drug Administration’s (FDA) widely anticipated final rule on national drug codes (NDCs) was published on Wednesday. The rule, which will take effect on 7 March 2033, replaces the current 10-digit code, with a uniform, 12-digit format.
  • Currently, the NDC for each drug marketed in the US is a unique 10-digit number which consists of three segments: the labeler code, the product code and the package code.
  • The rule aims to address an expected shortage of available codes within the next ten to fifteen years.
  • In an announcement, the FDA advised manufacturers to use the interim period before the new codes take effect to update their systems, processes, and infrastructure to accommodate the 12-digit NDC format.
  • FDA also stated that there will be a three-year transition period from 7 March 2033 to 6 March 2036 to allow manufacturers time to update labels and deplete old labeling stock.
  • FDA announced that “companies should begin updating their labeling as soon as possible to replace the 10-digit NDC format with the new 12-digit NDC format by adding leading zeros to the labeler code, product code and/or package code segments as needed. Companies must start labeling products with the 12-digit NDC as soon as possible once the transition period begins on March 7, 2033.”
  • Analysis: https://www.raps.org/news-and-articles/news-articles/2026/3/fda-issues-long-awaited-final-ndc-rule
  • FDA rule: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/national-drug-code-format

FDA ramps up crackdown on GLP-1 drug compounding with fresh batch of 30 warning letters

  • The FDA is taking no prisoners as it continues its efforts to combat widespread GLP-1 drug compounding. In its latest offensive, the agency has unleashed a fresh set of 30 warning letters targeting telehealth companies it says make “false or misleading” claims about compounded versions of popular obesity drugs.
  • The new warning letters, which were sent Feb. 20 and made public March 3, are an extension of the FDA’s September crackdown of misleading direct-to-consumer (DTC) drug advertising, the agency said in a press release. They also follow last month’s promise by FDA Commissioner Marty Makary, M.D., to take “swift action” against companies that mass-market copycat drugs.
  • In the letters, the FDA criticized an array of online wellness clinics for promoting compounded versions of semaglutide, tirzepatide or both drugs on their websites, arguing that they have misled consumers over the source of their compounded offerings.
  • The FDA scoured each website in December 2025, according to the letters, picking out instances of advertising that claimed compounded products contained the same ingredients as Novo and Lilly’s branded products or have been tested in clinical trials.
  • “Compounded drug products are not FDA-approved,” the letters say. “Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.”
  • Telehealth companies targeted in the warning letters have 15 days to address the FDA’s concerns. If the firms don’t respond, the agency threatened “legal action without further notice, including, without limitation, seizure and injunction,” the agency said.
  • https://www.fiercepharma.com/pharma/fda-ramps-crackdown-glp-1-drug-compounders-fresh-batch-30-warning-letters

Hospitals decry drugmakers' expanded claims reporting policies for 340B

  • The hospital lobby is asking federal officials to head off expanded data collection policies some drugmakers are implementing for providers participating in the 340B drug discount program.
  • The change was first broached by Eli Lilly and Company in January and requires all types of covered entities to provide claims-level data for all pharmacy and medical dispensations of most of the company’s drugs, including in-house pharmacy and contract pharmacy dispenses. It went into effect Feb. 1, with exemptions for a handful of states where such policies are restricted by law.
  • Earlier this week, Novo Nordisk followed suit, issuing a similar notice regarding its own products, with an effective date of April 1.
  • Both organizations had previously been collecting such data on a limited basis and said the ramp-up would help them spot duplicate discounts and compile the data needed to initiate audits when necessary.
  • Hospitals pushed back on Lilly’s initial change and are doing so again with Novo’s announcement amid concerns that inaction will encourage more drugmakers to follow their example.
  • With Lilly, the American Hospital Association (AHA) penned a letter to the Health Resources and Services Administration (HRSA), which oversees the 340B program, petitioning for a block. It warned that the increased reporting would “vastly increase the costs and burdens on 340B hospitals” and noted that prior compliance with Lilly’s similar requirement for contract pharmacy already takes weeks to months.
  • https://www.fiercehealthcare.com/providers/hospitals-decry-drugmakers-expanded-claims-reporting-policies-340b

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

How can HHS drive clinical AI adoption? The industry wish list is starting to take shape

  • In December, the federal health department asked for feedback on how to boost the use of artificial intelligence for clinical care. Health tech companies were not shy about suggesting extremely specific proposals that would benefit their businesses.
  • The request for information is part of the Department of Health and Human Services’ effort to implement President Trump’s directives encouraging greater adoption of AI and lighter regulation of the technology. The administration has already moved to scale back transparency requirements for AI built into electronic health record software and to lessen Food and Drug Administration regulation of AI tools that help doctors make clinical decisions. Under Trump, the Medicare innovation center has pushed forward an experiment intended to promote AI-based care, and another aimed at using AI to curb wasteful spending.
  • At the time of publication, just a fraction of the 7,300 comments submitted to the health department have been posted to the docket. Still, they offer a comprehensive industry wish list for AI, including reforms to health data privacy rules to account for AI training and calls for reliable AI reimbursement.
  • https://www.statnews.com/2026/03/02/hhs-clinical-ai-proposal-health-tech-wish-list/   (subscription required for full text)

Bipartisan healthcare cyber legislation advances in Senate

  • The Health Care Cybersecurity and Resilience Act this past week moved out of the Senate Health, Education, Labor, and Pensions Committee, and will now be considered in the full chamber.
  • The bipartisan legislation – which was first  introduced by Sen. Mark Warner, D-Virginia, and HELP Committee Chair Sen. Dr. Bill Cassidy, R-Louisiana, and colleagues back in November 2024 – is designed to shore up cybersecurity defenses and improve risk mitigation at healthcare organizations nationwide.
  • To help health systems better safeguard protected health information and other sensitive patient data in the face of increasingly sophisticated cyber threats, the Health Care Cybersecurity and Resiliency Act would provide grants to enable these organizations to improve their prevention and response capabilities.
  • The bill also contains provisions for training healthcare orgs on cybersecurity best practices and includes specific support tools designed for rural communities – helping them with best practices for breach prevention, resilience and coordination with federal agencies.
  • It also calls for better coordination between the Department of Health and Human Services and Homeland Security's Cybersecurity and Infrastructure Security Agency, and would modernize certain regulations to help HIPAA-covered entities refine their cybersecurity practices.
  • In addition, the act would require the HHS Secretary to develop and implement a cybersecurity incident response plan.
  • https://www.healthcareitnews.com/news/bipartisan-healthcare-cyber-legislation-advances-senate

KEY MEDTECH NEWS

MDUFA VI Agreement Nearing? Tracking User Fee Negotiations

  • FDA wants to start crafting a formal commitment letter with industry groups this month detailing the structure of company fees and FDA commitments under a reauthorized device user fee agreement.
  • The agency directed negotiators “to hold March meeting dates in order to finalize MDUFA VI negotiations and begin the commitment letter writing process,” during a February 4 session, according to meeting minutes published by FDA [in early March].
  • That plan would put the process about a month behind what the agency signaled last October when the talks began. At that time, the agency told patient and clinical groups that it wanted the core negotiations wrapped up in February followed by a six-month effort with industry to write the commitment letter agreement.
  • Under that timeline, if a preliminary agreement is reached in March, the commitment letter might be released by around September, giving the agency about three months to collect public feedback before the parties are supposed to submit the agreement to Congress in January. The goal is to give lawmakers enough time to pass necessary reauthorization before the current MDUFA V program expires in September 2027.
  • Press: https://www.mystrategist.com/market-pathways/article/approaching_agreement_on_mdufa_vi_tracking_user_fee_negotiations_.html   (subscription required for full text)
  • FDA Meeting Notes: https://www.fda.gov/media/191284/download?attachment

KEY ACRONYMS

  • ACIP = Advisory Committee on Immunization Practices
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CMS = Centers for Medicare & Medicaid Services
  • DOJ = Department of Justice
  • FDA = Food and Drug Administration
  • GENEROUS = GENErating cost Reductions fOr U.S. Medicaid
  • HHS = Department of Health and Human Services
  • HRSA = Health Resources and Services Administration
  • MA = Medicare Advantage
  • MAHA = Make America Healthy Again
  • MOU = Memoranda of Understanding
  • NDC = national drug code
  • NIH = National Institutes of Health
  • PEPFAR = President's Emergency Plan for AIDS Relief
  • USAID = U.S. Agency for International Development
  • USPSTF = U.S. Preventive Services Task Force

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