Blog | 2/20/2026

Sharp Strategy Spotlight: February 20, 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 February 19, 2026. The details and broad themes may have changed.

KEY FEDERAL GOVERNMENT NEWS

NIH director will also run CDC

  • National Institutes of Health director Jay Bhattacharya will also become acting director of the Centers for Disease Control and Prevention as the Trump administration continues a shakeup of its senior health leadership, two sources told Axios.
  • Why it matters: The CDC has lacked a permanent political leader since August, when Health Secretary Robert F. Kennedy Jr. fired career scientist Susan Monarez.
    • Deputy Health Secretary Jim O'Neill, who is leaving his post, has been acting CDC director since then, presiding over the agency during a period of heavy turnover from staff reductions and DOGE-directed layoffs.
    • Bhattacharya's appointment was first reported by the New York Times.
  • Driving the news: Bhattacharya is a former Stanford professor who has tried to deflect controversy over the administration's health agenda while others on the Trump health team have leaned into their roles as disruptors.
    • He's presided over NIH during a period of unprecedented budget cuts and grant freezes, taking credit for fighting what he called "politicized science" while telling Congress he didn't accept the job to terminate grants.
    • Bhattacharya rose to prominence in the Trump world as a vocal opponent of COVID-era lockdowns.
    • He cowrote the Great Barrington Declaration, a petition from a group of scientists that argued for allowing COVID to spread among young, healthy people to reach herd immunity faster.
  • The permanent CDC director has to be confirmed by the Senate, which could be a big political lift heading into the midterm elections.
  • https://www.axios.com/2026/02/18/nih-jay-bhattacharya-cdc-director   (subscription required for full text)

RFK Jr. shakes up top health department staff

  • Two senior Trump administration health officials — including one who was running the Centers for Disease Control and Prevention — are leaving their posts as part of a staff shakeup by Health Secretary Robert F. Kennedy Jr. ahead of the midterm elections, two sources confirmed to Axios.
  • Why it matters: The departures of deputy health secretary Jim O'Neill and general counsel Mike Stuart coincide with Kennedy's public emphasis on top administration priorities like cleaning up the food supply and lowering drug prices.
  • Driving the news: The staff shuffle will effectively make the current Medicare director Chris Klomp chief of staff under Kennedy, overseeing all of the department's operations.
  • https://www.axios.com/2026/02/13/kennedy-rfk-hhs-staff-cuts-2026-elections

Top Republican eyeing FDA overhaul

  • Sen. Bill Cassidy (R-La.) on Tuesday unveiled his proposal for modernizing the Food and Drug Administration (FDA), calling on the agency to reform some of its practices and embrace innovations in order to get more products approved for patients.
  • In the report titled “Patients and families: Building the FDA of the future,” Cassidy, chair of the Senate Committee on Health, Education, Labor, and Pensions, lamented that “unnecessary bottlenecks slow patients and consumers getting the products they need.”
  • Drawing from a “a diverse group of stakeholders,” the report listed 15 recommendations to help the FDA modernize itself.
  • Press: https://thehill.com/policy/healthcare/5741597-cassidy-report-fda-innovation/
  • Report: https://www.help.senate.gov/imo/media/doc/fda_report.pdf

Major health plans join CMS ACCESS outcomes-based care model

  • What’s new: Major health payers representing 165 million Americans with Medicare Advantage, Medicaid and private health insurance plans pledged to adopt an outcomes-based payment structure aligned to the Medicare-focused ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model.
  • Why it matters: The pledge is an important step to alignment across Medicare, Medicaid, and commercial payers around payments for technology-supported care that incentivize flexibility in care delivery, coordination with primary care and clinicians and — most importantly — measurable improvements in patient health outcomes rather than volume of services.
  • What to expect: The ACCESS Model begins its 10-year performance period in July 2026;  under the ACCESS Payer Pledge, payers commit to offering payment arrangements that align with core principles of the model by January 1, 2028.
  • The big picture: Payers’ voluntary alignment to ACCESS builds on earlier support from clinician and patient societies acknowledging the necessity of making technology- supported [sic] more accessible to all Americans, empowering them to meet their health goals and prevent or manage their chronic conditions; this is just the latest example of CMS using convening power to align stakeholders towards a common goal.
  • Additional Details: Payers that have signed the pledge include Arkansas Blue Cross and Blue Shield, Blue Shield of California, Blue Cross and Blue Shield of Minnesota, Blue Cross Blue Shield of North Dakota, BlueCross BlueShield of Tennessee, CareFirst BlueCross BlueShield, Centene, Cigna, CVS Health, Devoted Health, Guidewell, Horizon Blue Cross Blue Shield of NJ, Humana, UnitedHealthcare.
  • Press: https://www.mobihealthnews.com/news/major-health-plans-join-cms-access-outcomes-based-care-model
  • CMS News: https://www.cms.gov/priorities/innovation/major-health-plans-join-access-payer-pledge

CMS Head Oz Vows Continued Vaccine Coverage, Urges Measles Shots

  • Mehmet Oz, head of the US Centers for Medicare and Medicaid Services, pledged continued insurance coverage for all recommended vaccinations in the country and urged people to get the measles shot as infections skyrocket. His comments come as the Trump administration remakes the nation’s approach to immunizations by promoting personal choice and backing away from once-universal endorsements of shots that have controlled deadly disease outbreaks.
  • Changes to the vaccine schedule have added to mounting confusion over which vaccines will be covered by government programs that often pay for childhood shots.
  • https://www.bloomberg.com/news/articles/2026-02-17/cms-head-oz-vows-continued-vaccine-coverage-urges-measles-shots   (subscription required for full text)

Upcoming meeting of federal vaccine panel may be postponed after HHS missed deadlines

  • Federal officials have missed the legal deadline to notify the public of an upcoming meeting of a vaccine advisory panel that was planned for next week, raising questions about whether the meeting, expected to be closely monitored for signs of the Trump administration’s intents, will be postponed.
  • Under federal law, agencies are required to announce advisory committee meetings, including those of the Advisory Committee on Immunization Practices, by certain periods ahead of time to allow for public input. A Federal Register notice puts that deadline at seven calendar days prior to the panel’s gathering, but a federal rule last updated in 2001 says the notice must be posted at least 15 days prior.
  • As of Wednesday, no notice had been posted by the Department of Health and Human Services, meaning the agency has missed both deadlines. STAT has asked HHS if the meeting, one of three regularly scheduled ACIP meetings held annually, will take place, but has not yet received a reply.
  • https://www.statnews.com/2026/02/18/cdc-vaccines-acip-meeting-may-be-postponed/   (subscription required for full text)

FDA CIO Questions Training Budget, Urges Staff To Upskill Through Free YouTube Tutorials

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

Key US infectious-diseases centre to drop pandemic preparation

  • Staff members at the United States’s premier infectious-disease research institute have been instructed to remove the words “biodefense” and “pandemic preparedness” from the institute’s web pages, according to e-mails Nature has obtained.
  • The directive comes amid a broader shake-up at the US National Institute of Allergy and Infectious Diseases (NIAID), one of 27 institutes and centres at the National Institutes of Health (NIH). The NIAID is expected to deprioritize the two topics in an overhaul of its funded research projects, according to four NIAID employees who spoke to Nature on the condition of anonymity, because they are not authorized to speak to the press.
  • NIH director Jay Bhattacharya explained the restructure at an event with other top agency officials on 30 January. “It’s a complete transformation of [the NIAID] away from this old model” that has historically prioritized research on HIV, biodefence and pandemic preparedness, he said. The institute will focus more on basic immunology and other infectious diseases currently affecting people in the United States, he added, rather than on predicting future diseases.
  • About one-third of the NIAID’s US$6.6-billion budget currently funds projects involving emerging infectious diseases and biodefence. The research studies pathogens of concern and monitors their spread, and develops medical countermeasures against threats from radiation exposure, chemicals and infectious diseases.
  • https://www.nature.com/articles/d41586-026-00468-1   (subscription required for full text)

F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine

  • The Food and Drug Administration reversed its decision on Moderna’s flu vaccine and has agreed to review it for possible approval.
  • Just last week, Moderna announced that the agency had rejected its application for review of a new flu vaccine. The F.D.A. said the company’s research design had been flawed.
  • But in subsequent discussions, the agency had relented and agreed to begin a review, the company said on Wednesday. As part of the revised approach, Moderna said that it had agreed to split up its application for the flu vaccine based on age. It plans to seek standard approval for people 50 to 64 years old, and accelerated approval for those 65 and older. The company also said it had agreed to conduct an additional study among those 65 and older once the vaccine reached the market.
  • The F.D.A. did not provide a detailed explanation on Wednesday as to why it suddenly changed direction. But its initial refusal to even consider Moderna’s application drew swift and highly public rebukes, and startled the pharmaceutical industry — beyond just vaccine manufacturers — as well as investors.
  • https://www.nytimes.com/2026/02/18/health/fda-moderna-flu-vaccine-mrna.html   (subscription required for full text)

Clinics Sour on CMS After Agency Scraps 10-Year Primary Care Program Only Months In

  • In March, [Celo Health Center in North Carolina clinic administrators] received an email during the Department of Government Efficiency’s whirlwind of federal cuts: The Centers for Medicare & Medicaid Services would soon shutter Making Care Primary, a year into what was supposed to be a 10-year program.
  • Nearly 700 practices in eight states enrolled in Making Care Primary. North Carolina had 23 clinics and centers in the program, the most of any state, followed by Washington, New Mexico, and New York. Doctors who had signed up for it said they were stunned.
  • Now, CMS’ Innovation Center, which created Making Care Primary, is set to launch a new 10-year program to boost primary care called the Long-term Enhanced ACO Design, known by its acronym LEAD. In that program, funding will be sent to health care organizations, often managed by companies, instead of directly to primary care doctors and clinics.
  • CMS wouldn’t say how much the programs cost. But it maintained that eliminating Making Care Primary reduced spending without sacrificing its mission to improve quality of care. Nixing Making Care Primary and three other programs at the agency — including another focused on primary care — would save taxpayers $750 million, CMS said at the time.
  • Making Care Primary “was not on track to meet its intended savings goal,” CMS spokesperson Alexx Pons said. Innovation Center models are meant to save money over time, in part by improving patients’ access to health care and helping them avoid costly hospital visits. Practices that signed up for Making Care Primary and want to join LEAD will have to apply for the program beginning in March.
  • Yet Making Care Primary’s elimination has created skepticism among doctors.
  • Analysis: https://kffhealthnews.org/news/article/cms-mcp-lead-primary-care-model-canceled-rural-health-north-carolina/
  • Making Care Primary: https://www.cms.gov/priorities/innovation/where-innovation-happening#model=making-care-primary-mcp-model
  • Long-Term Enhanced ACO Design: https://www.cms.gov/priorities/innovation/innovation-models/lead

FOIA lawsuit filed against State Department for PEPFAR records

  • The Council for Global Equality and Physicians for Human Rights have filed a Freedom of Information Act lawsuit against the State Department for PEPFAR-related data and documents.
  • The groups, which Democracy Forward represents, filed the lawsuit in U.S. District Court for the Southern District of New York on Wednesday.
  • Then-President George W. Bush in 2003 signed legislation that created PEPFAR. UNAIDS Executive Director Winnie Byanyima last March said PEPFAR has saved 26 million lives around the world.
  • The Trump-Vance administration in January 2025 froze nearly all U.S. foreign aid spending for at least 90 days. Secretary of State Marco Rubio later issued a waiver that allowed PEPFAR and other “life-saving humanitarian assistance” programs to continue to operate during the freeze.
  • The Washington Blade has previously reported PEPFAR-funded programs in Kenya and other African countries have been forced to suspend services and even shut down because of gaps in U.S. funding. HIV/AIDS activists have also sharply criticized the Trump-Vance administration over reported plans it will not fully fund PEPFAR in the current fiscal year.
  • The lawsuit notes the Council for Global Equality and Physicians for Human Rights have “filed several FOIA requests” with the State Department for PEPFAR-related data and documents. The groups filed their most recent request on Jan. 30.
  • “On Jan. 30, 2026, plaintiffs, through counsel, sent State a letter asking it to commit to prompt production of the requested records,” reads the lawsuit. “State responded that the request was being processed but did not commit to any timeline for production.”
  • “Plaintiffs have received no subsequent communication from State regarding this FOIA request,” it notes.
  • https://www.washingtonblade.com/2026/02/13/foia-lawsuit-filed-against-state-department-for-pepfar-records/

KEY BIOPHARMA NEWS

Experts react to FDA’s shift to single pivotal trials for most drugs

  • The US Food and Drug Administration (FDA) will, by default, require only one clinical trial to demonstrate that a product meets its regulatory requirements for safety and efficacy in most cases, according to two top officials. Former top FDA officials who spoke to Focus raised concerns about how the policy was developed and announced.
  • In an article published in the New England Journal of Medicine (NEJM) on Wednesday, FDA Commissioner Marty Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER) announced a major shift in the agency’s longstanding evidentiary standards for drugs.
  • “Going forward, the FDA’s default position is that one adequate and well-controlled study, combined with confirmatory evidence, will serve as the basis of marketing authorization of novel products,” Makary and Prasad wrote. “The FDA will carefully examine all aspects of study design with particular focus on controls, end points, effect size, and statistical protocols.
  • “Without examination of the quality of a study, two trials may even provide a false assurance,” they added. “The FDA expects a surge in drug development in response to our initiative.”
  • In the article, the officials laid out their rationale for changing the decades-old standard requiring at least two confirmatory trials for drugs and biologics, arguing that the previous standard was based on the limited understanding of biology of the time and that there are alternative ways to ensure products meet safety and efficacy requirements.
  • Peter Pitts, president of the Center for Medicine in the Public Interest (CMPI) and a former FDA associate commissioner, said the announcement raises many questions about how the policy was developed and how the agency intends to implement it.
  • Pitts said FDA should have announced the policy through official channels, such as in a press release referencing a robust and detailed study conducted by the agency that included feedback from key stakeholders. He said if such a document exists, it should be made public so that everyone can evaluate the rationale behind the initiative.
  • Analysis: https://www.raps.org/news-and-articles/news-articles/2026/2/experts-react-to-fda-s-shift-to-single-pivotal-tri
  • NEJM article: https://www.nejm.org/doi/full/10.1056/NEJMsb2517623  

Trump administration restarts its efforts to pilot 340B rebates

  • The Health Resources and Services Administration (HRSA) released a request for information (RFI) asking stakeholders and the public for input on whether and how such a model should be implemented for 340B, which, for over 30 years, has required drug manufacturers to provide upfront discounts on their products to help subsidize safety-net care.
  • The 340B program has grown substantially over the past several years, prompting lawmaker scrutiny and attempts from drugmakers to clamp down on what they describe as health systems’ margin-padding abuse of the program.
  • Last year, the administration took up those concerns by forming a pilot program that would have had nine drugmakers swap out discounts for after-the-fact rebates for a limited set of products. That test run was set to go into effect on Jan. 1, but was blocked by the court after hospitals alleged in a lawsuit that HRSA had failed to meet administrative requirements around public feedback amid a hasty rollout.
  • After a mutual agreement with plaintiff hospital groups and promises to expand the rulemaking timeline, HRSA has taken the first steps on a mulligan. Friday’s RFI sets a March 19 deadline for stakeholders to weigh in on what the agency should consider when putting together its second attempt.
  • Specifically, it calls for input on potential cash-flow impacts, whether participating providers’ reliance on upfront discounts “are reasonable” in light of the government’s statutory authority to implement either “rebate or discount,” and any proposed alternatives and scope-limiting measures “including safeguards to promote the integrity of the 340B Program.”
  • Other areas of the RFI speak directly to hospitals’ concerns. HRSA said it wants to hear about whether a potential pilot would require participating providers to hire more staff or modify their IT systems, and what specific guardrails should be put in place for drugmakers to issue a rebate claim denial.
  • Press: https://www.fiercehealthcare.com/providers/trump-administration-restarts-its-efforts-pilot-340b-rebates
  • HHS RFI: https://www.federalregister.gov/public-inspection/2026-03042/request-for-information-340b-rebate-model-pilot-program

Pharma groups pressure FDA to finalize NDC rule

  • Pharmaceutical industry groups, drugmakers, and other industry stakeholders are pressuring the US Food and Drug Administration (FDA) to finalize its proposed rule to update the format of the National Drug Code (NDC) by the end of March 2026.
  • The NDC consists of a labeler code, product code, and packaging code. Due to new labelers constantly coming online, FDA anticipates that it will run out of 5-digit labeler codes by 2032 at the earliest and new NDC formatting will need to be put in place to accommodate longer NDCs. If the new format and system updates necessary to support this new format are not developed and operational across all systems by that time, the delivery of medications to patients could face significant disruptions.
  • This information was conveyed in a letter dated 13 February 2026 and addressed to Russell Vought, director of the Office of Management and Budget (OMB); Robert Kennedy Jr., Secretary of the Department of Health and Human Services (HHS); Marty Makary, FDA Commissioner; and Vince Haley, director of the Domestic Policy Council.
  • This letter was signed by representatives of 39 pharmaceutical companies and trade groups, including AbbVie, the Association for Accessible Medicines (AAM), Apotex, GSK, Novartis, and the Pharmaceutical Research and Manufacturers of America (PhRMA). A serialization expert from Novartis also spoke to Focus about his concerns about the timing of the NDC final rule.
  • https://www.raps.org/news-and-articles/news-articles/2026/2/pharma-groups-pressure-fda-to-finalize-ndc-rule

KEY ACRONYMS

  • ACCESS = Advancing Chronic Care with Effective, Scalable Solutions
  • ACIP = Advisory Committee on Immunization Practices
  • CBER = Center for Biologics Evaluation and Research
  • CDC = Centers for Disease Control and Prevention
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • FOIA = Freedom of Information Act
  • HHS = Department of Health and Human Services
  • HRSA = Health Resources and Services Administration
  • LEAD = Long-term Enhanced ACO Design
  • MAHA = Make America Healthy Again
  • NDC = National Drug Code
  • NIAID = National Institute of Allergy and Infectious Diseases
  • NIH = National Institutes of Health
  • PBM = pharmacy benefit manager
  • PEPFAR = President's Emergency Plan for AIDS Relief
  • RFI = request for information
  • WHO = World Health Organization

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