Blog | 2/27/2026

Sharp Strategy Spotlight: February 27, 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 26, 2026. The details and broad themes may have changed.

KEY HEALTH NEWS (GLOBAL)

US to end health aid to Zimbabwe after funding talks collapse

  • The United States has said it will wind down health assistance to Zimbabwe after negotiations collapsed on a U.S.-proposed funding deal that the African nation rejected in part over a requirement to share sensitive health data.
  • The loss of the southern African nation’s largest health donor casts uncertainty over programs to combat HIV and the public health sector in one of the world’s most vulnerable health systems, where patients often must supply even basic items such as bandages at clinics and often have to buy their own medicines due to shortfalls.
  • Zimbabwean authorities said the funding proposal carried conditions they could not accept. The decision was driven by concerns over data sharing concerns, fairness, sovereignty and Washington’s broader shift away from global health institutions, government spokesperson Nick Mangwana said on Wednesday.
  • Mangwana said the U.S. proposal was tied to “comprehensive access to Zimbabwe’s sensitive health data, including virus samples and epidemiological information from our citizens.”
  • He said President Emmerson Mnangagwa directed that negotiations be terminated because the U.S. was not offering a “corresponding guarantee of access to any medical innovations — such as vaccines, diagnostics, or treatments — that might result from that shared data.”
  • https://apnews.com/article/zimbabwe-us-health-funding-deal-b2d3fce8b9a340c53d117675319be120

KEY FEDERAL GOVERNMENT NEWS

FDA Proposes New Approval Pathway for Rare Disease Gene Therapy

  • The FDA on Monday unveiled draft guidance for a new "plausible mechanism" approval pathway for ultra-rare disease treatments.
  • "What is a 'plausible mechanism' pathway? It's common sense," FDA Commissioner Marty Makary, MD, MPH, said at a press conference at HHS headquarters. "For the first time, the FDA is issuing guidance giving drug developers of ultra-rare disease therapies a path to accelerated or traditional approval based on the experience of individuals."
  • According to an FDA press release, the draft guidance "focuses on therapies that target a specific genetic, cellular, or molecular abnormality and are designed to correct or modify the underlying cause of disease." Criteria for approval under this pathway would include:
    • Identifying the disease-causing abnormality
    • Demonstrating the therapy targets the root cause or proximate biological pathway
    • Relying on well-characterized natural history data in untreated patients
    • Confirming successful target drugging or editing
  • Manufacturers who seek traditional approval for their therapies should demonstrate that the therapy leads to "improvement in clinical outcomes, disease course, or biomarkers if they are established to predict clinical benefit," the FDA noted.
  • Asked what distinguishes an "ultra-rare" disease from a rare disease, Tracy Beth Høeg, MD, PhD, acting director of the FDA's Center for Drug Evaluation and Research, said there was no clear line.
  • Press: https://www.medpagetoday.com/publichealthpolicy/fdageneral/120010
  • Draft Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-plausible-mechanism-framework-develop-individualized-therapies-target-specific

FDA’s CDER agenda includes new guidance on digital health technologies and AI in manufacturing

  • The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has published a new guidance agenda that outlines the guidance it plans to release this year, including both new and revised guidance documents. This latest agenda features several additions to the agency's list.
  • Since last year, the agenda has included new guidelines on how to interact with the FDA concerning the use of digital health technologies in clinical investigations of drugs and biological products. Additionally, it features new guidance on the application of artificial intelligence (AI) and machine learning (ML) in pharmaceutical manufacturing. (RELATED: CDER announces new guidance agenda for 2025, Regulatory Focus 23 January 2025)
  • The agenda includes 81 guidelines that are scheduled for release, many of which are carried over from the January 2025 agenda. It covers 12 topics, including biosimilars, clinical and medical issues, compounding, generics, labeling, and pharmaceutical quality, chemistry, manufacturing, and controls (CMC). As in previous years, this year's agenda emphasizes generic drugs, with 26 of the topics focusing specifically on them.
  • This year's agenda also includes at least 15 new items.
  • CDER said that it is not obligated to follow this list and may issue guidance documents that are not included. Additionally, differing priorities from the Trump administration could influence the documents that are ultimately published.
  • Analysis: https://www.raps.org/news-and-articles/news-articles/2026/2/fda-s-cder-agenda-includes-new-guidance-on-digital
  • CDER agenda: https://www.fda.gov/media/185228/download

CMS unveils new initiatives aimed at cracking down on healthcare fraud

  • The Trump administration announced late Wednesday new steps it says are designed to crack down on fraud.
  • The new push, which comes just one day after President Donald Trump highlighted the White House's focus on fraudulent behavior across multiple social programs, includes three key prongs.
  • In the first piece, the Centers for Medicare & Medicaid Services (CMS) said it would hold back $259.5 million in Medicaid funding for the state of Minnesota.
  • In addition, the CMS said it is taking aim at fraudulent billing conducted by durable medical equipment companies, saying a six-month moratorium on new Medicare enrollment for certain DME suppliers avoided $1.5 billion in fraudulent bills.
  • As it continues to put a focus on addressing fraud, waste and abuse in healthcare, the CMS said it is also seeking feedback on additional fraud prevention strategies it could use in a future rule as part of the Comprehensive Regulations to Uncover Suspicious Healthcare, or CRUSH, initiative.
  • The CMS is looking for strategies across different programs, including Medicare, Medicaid, the Children's Health Insurance Program and the Affordable Care Act's insurance exchanges. The agency said stakeholders can submit feedback that leans on existing programs as well as ideas for new regulatory approaches.
  • Press: https://www.fiercehealthcare.com/regulatory/cms-unveils-new-initiatives-aimed-cracking-down-healthcare-fraud
  • CMS statement: https://www.cms.gov/newsroom/press-releases/trump-administration-prioritizes-affordability-announcing-major-crackdown-health-care-fraud

Trump’s atypical surgeon general pick faces Senate scrutiny

  • After months of delay, President Trump’s nominee for U.S. surgeon general, Casey Means, appeared before the Senate, facing intense questions over her qualifications, personal health care practices and career as a social media influencer.
  • Means appeared before the Senate Committee on Health, Education, Labor and Pensions (HELP) on Wednesday, about four months after her initial hearing was rescheduled when she went into labor just hours before it was meant to begin.
  • Trump picked Means, a graduate of Stanford University School of Medicine, to be his surgeon general more than half a year ago after the qualifications of his first pick, Janette Nesheiwat, came under question.
  • Means would be an unprecedented pick, not having completed her medical residency or having an active medical license.
  • She is the sister of White House senior adviser Calley Means, one of Health Secretary Robert F. Kennedy Jr.’s top advisers, and a prominent “Make America Healthy Again” influencer in her own right.
  • Former surgeons general have spoken out against her nomination.
  • https://thehill.com/policy/healthcare/5755656-casey-means-senate-confirmation-hearing-takeaways/

CMS plans beta launch of federal provider directory

  • CMS outlined next steps for its Medicare Advantage provider directory and shared plans to “beta launch” a broader National Provider Directory later this year, according to a Feb. 18 document.
  • The agency has structured the initiative in three phases. The first phase, launched in fall 2025, displayed Medicare Advantage provider data during open enrollment in an interim tool. Lawmakers raised concerns about conflicting and duplicative information in that data, which was collected by a third-party vendor.
  • Phase two establishes a system for MA organizations to directly provide CMS with current information on in-network providers and facilities, according to the document. For this directory, testing will be underway between May and August, with plans to release it Oct. 1.
  • From there, the third and final phase will focus on testing and launching a National Provider Directory.
  • Details on the national directory are sparse, but CMS’ document said it will “serve as connective tissue between healthcare providers, payers, data networks, and their respective interoperability frameworks.”
  • The MA directory will be included in the National Provider Directory, according to the document.
  • https://www.beckershospitalreview.com/legal-regulatory-issues/cms-to-launch-federal-directory-of-hospitals-physicians/

CBO estimates Medicare Trust Fund will run out in 2040

  • The Congressional Budget Office (CBO) has updated its estimates around the Medicare Trust Fund and now expects the fund to run dry in 2040.
  • The CBO said in a blog post Monday that the trust fund's balance is set to grow each year through 2031, but, after that, spending will begin to overtake revenue until it eventually runs out in 2040. This marks a significant change from the organization's 2025 estimates, cutting 12 years off of the lifespan of the fund compared to previous projections.
  • The Medicare Trust Fund is used to cover benefits under Part A, or the traditional program, including inpatient hospital services, skilled nursing, home health and hospice services. It's funded by multiple sources, with the bulk (about three-quarters) of the fund's income over the next 30 years deriving from the Medicare payroll tax.
  • About an eighth of the trust fund's income is from income taxes on Social Security benefits, per the blog post.
  • The organization cites changes made in the One Big Beautiful Bill Act, or H.R. 1, as playing a role in worsening the outlook for the trust fund. Under that massive reconciliation bill, the feds lowered tax rates and added a new tax deduction for taxpayers aged 65 and up, which is decreasing revenue from Social Security taxes.
  • In addition, the CBO estimates that revenue from payroll taxes will be lower due to lower earnings projections
  • https://www.fiercehealthcare.com/regulatory/cbo-estimates-medicare-trust-fund-will-run-out-2040

Ralph Abraham, No. 2 official at CDC, abruptly steps down

  • The drama and chaos surrounding the leadership of the Centers for Disease Control and Prevention have taken another twist, with the announcement Monday that the agency’s No. 2 official, Ralph Abraham, has resigned.
  • A statement posted to the CDC’s website said Abraham, a former Louisiana surgeon general who was sworn in as the agency’s deputy secretary general only 2 1/2 months ago, stepped down to address “unforeseen family obligations.” The resignation is effective immediately.
  • “It has been an honor to serve alongside the dedicated public health professionals at the CDC and to support the agency’s critical mission,” Abraham said in the statement.
  • CDC staff were not directly informed of Abraham’s departure but instead learned about it from the statement on the agency’s website or from media reports, several employees told STAT.
  • https://www.statnews.com/2026/02/23/ralph-abraham-cdc-resigns   (subscription required for full text)

RFK Jr.'s CDC panel to discuss Covid vaccine injuries in upcoming meeting

HHS adviser hopes prior authorization reform happens in ‘double-digit months,’ not years

  • A top U.S. health official told a room full of doctors on Wednesday that he hopes the Trump administration’s efforts to whittle down the insurance industry’s use of prior authorizations will produce results “in double-digit months” instead of years, calling on his audience to also put pressure on their technology vendors to standardize the process.
  • “There should be no human working on prior authorization, period,” Chris Klomp, director of the Center for Medicare, said. “We have the technology to effectuate appropriate clinical care based on your judgment, your decisions, very, very quickly, and that’s what we’re driving for.”
  • Klomp, who now also serves as a senior counselor at the Department of Health and Human Services, overseeing the department’s day-to-day operations, made his comments at the American Medical Association’s national advocacy conference in Washington, D.C.
  • https://www.statnews.com/2026/02/25/prior-authorization-chris-klomp-ama/   (subscription required for full text)

VFW says new federal rule could lower disability compensation for millions of veterans

  • On Tuesday, the Department of Veterans Affairs amended an interim final rule that it says clarifies the VA’s longstanding interpretation of the CFR 4.10 in the Code of Federal Regulations. It provides the basis for evaluating disabilities for veterans.
  • By doing so, the rule amends the text to correct judicial interpretations that VA has concluded misconstrue the rule of medication and treatment in evaluating functional impairment.
  • The VFW made a statement on their concerns about what this rule will do.
  • That change reads in part: “Specifically, this amendment clarifies that veterans should be compensated for the actual level of functional impairment they experience and, therefore, that the ameliorative effects of medication should not be estimated or discounted when evaluating the severity of a veteran’s disability at the time of the disability examination.”
  • The rule change could lower compensation for millions of veterans who suffer from mental health issues, physical ailments such as bone or muscle injuries and hypertension.
  • Experts are worried the change could lead to veterans choosing not to take medication so as to be rated higher and to receive larger compensation.
  • https://thehill.com/policy/defense/5745504-vfw-veterans-disability-compensation-va/

HHS commits up to $144M to study anti-aging approaches via ARPA-H

HHS Official: Whole-Of-Government Effort Needed To Onshore Essential Medical Products

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

15 states sue HHS over changes to childhood vaccine schedule

  • Frustrated by a recent, dramatic overhaul of the U.S. childhood immunization schedule, 15 Democrat-led states have sued the Trump administration in a bid to undo those changes as well as what they alleged to be an “unlawful replacement” of a key vaccine panel.
  • The lawsuit, filed by 14 attorneys general and the governor of Pennsylvania, seeks to rescind the new schedule adopted by the Department of Health and Human Services and vacate the committee, known as ACIP, reformed last year by Secretary Robert F. Kennedy Jr.
  • Kennedy, the Centers for Disease Control and Prevention and the agency’s acting director, Jay Bhattacharya, are named as defendants in the suit.
  • Following a Trump directive, the CDC in January suddenly upended the U.S.’ longstanding immunization schedule, narrowing the number of universally recommended shots to 11 from the previous 17.
  • The new schedule “will damage public health by decreasing vaccine uptake and increasing rates of vaccine-preventable diseases, including by creating confusion, spreading misinformation contrary to established scientific evidence, and increasing vaccine hesitancy,” the plaintiffs charged in the lawsuit.
  • https://www.biopharmadive.com/news/15-states-sue-hhs-vaccine-schedule-changes-acip/813026/

Industry groups lay out potential legal strategy against CMS pricing demos

  • Pharma trade groups are laying the foundation for potential legal challenges to two CMS pricing demonstrations that they say are much broader than legally allowed and aren’t actually intended to save patients money.
  • The rebukes were outlined in public comments from the trade groups BIO and PhRMA on two yet-to-be-finalized demos released by the Center for Medicare and Medicaid Innovation that aim to lower drug prices for Medicare Part B and Part D, respectively. The demo addressing Part B is called GLOBE and the Part D demo is called GUARD.
  • The two demos aim to test new rebate programs tied to the price of drugs from a basket of nations outside of the US. They would be tested among a random 25% of beneficiaries of the Part B and Part D programs.
  • But the industry groups say the programs would do very little to impact the cost of medicine for seniors because so many have supplemental insurance that limits out-of-pocket costs for their prescriptions.
  • https://endpoints.news/industry-groups-lay-legal-groundwork-against-pricing-demos/   (subscription required for full text)

KEY BIOPHARMA NEWS

Senate Leaders Warn Defense Department About Procuring Generic Drugs Overseas

  • Senate leaders are urging the Department of Defense to prioritize the purchase of generic drugs manufactured in the United States, warning that the country’s overreliance on foreign factories poses an “existential risk” to the military.
  • In a letter last week, Sens. Rick Scott, R-Fla., and Kirsten Gillibrand, D-N.Y., asked Defense Department Secretary Pete Hegseth to provide information about drugs or key ingredients purchased from foreign sources and how long the department’s inventory would last if China restricted exports.
  • They also sought details about whether the Food and Drug Administration had imposed any import bans on the department’s suppliers.
  • The letter cited ProPublica reporting last year that found the FDA allowed dozens of foreign drugmakers, mostly in India and China, to continue sending generic medication to the U.S. even after the factories were banned because of serious safety and quality-control failures.
  • Press: https://www.propublica.org/article/senators-warn-hegseth-foreign-drug-manufacturers
  • Letter: https://www.aging.senate.gov/imo/media/doc/letter_to_hegseth_re_generic_drugs.pdf

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

HHS launches $500K challenge to turn EHR data into clinical insights

  • HHS’ Assistant Secretary for Technology Policy is offering $500,000 for health IT developers to turn raw EHR data into actionable insights for clinicians and patients.
  • The EHIgnite Challenge, which launched Feb. 23, will grant $10,000 to each of nine winners for the first phase then prizes for finalists of $250,000, $100,000 and $50,000, with bonus recognition for multi-EHR interoperability, according to a news release shared with Becker’s.
  • “While health IT developers have been required to export EHI [electronic health information] since December 2023, ‘computable’ doesn’t always mean ‘usable,'” the release stated. “Raw exports are often overwhelming and difficult to integrate. That’s a problem the EHIgnite Challenge is hoping to solve. The challenge seeks solutions that improve the usability of single-patient EHI exports.”
  • HHS is looking for ideas like interactive patient tools, filtering by clinical domains, and streamlined payer workflows. The agency is hosting a webinar about the challenge March 11.
  • Press: https://www.beckershospitalreview.com/healthcare-information-technology/ehrs/hhs-launches-500k-challenge-to-turn-ehr-data-into-clinical-insights/
  • Site: https://ehignitechallenge.org/

FDA taps AI executive to lead digital health center

  • The Food and Drug Administration has tapped a former executive from a health artificial intelligence company to lead its digital health center.
  • Rick Abramson, formerly a chief medical officer at a subsidiary of Harrison.ai, which develops AI products to interpret radiological images, is the new director of the Digital Health Center of Excellence, according to two people familiar with the appointment. The move comes as the agency wrestles with the future regulation of AI.
  • Abramson has since last summer been working as a senior adviser in the commissioner’s office. In January, the agency announced it would soften the regulation of AI products that support clinician decision-making, and allow more wellness products to avoid FDA review.
  • Three agency employees told STAT at the time that the push to deregulate was led by Abramson and two other officials in the commissioner’s office: Jared Seehafer and Shantanu Nundy.
  • https://www.statnews.com/2026/02/19/fda-appoints-new-digital-health-center-director/   (subscription required for full text)

CMS launches digital health app library for Medicare beneficiaries

  • CMS has rolled out an app directory for Medicare recipients as part of the agency’s push to digitize healthcare.
  • The Medicare App Library seeks solutions that fall under one of three use cases: “kill the clipboard,” conversational AI assistants, or diabetes and obesity prevention and management.
  • “We are calling on health app developers, tech-enabled organizations, and innovators to voluntarily align around a shared framework for data and access that empowers people, improves care, and accelerates progress,” CMS stated Feb. 23. “This is a movement, not a mandate. It is a call to action, not a regulation. Let’s show what’s possible when we work together — and finally bring healthcare into the modern era.”
  • Patient-facing apps must meet six requirements: identity verification, Medicare connectivity, permission to be a featured option on the app store, HIPAA compliance, CMS review, and trial access (if not free). Participants in the agency’s ACCESS program for chronic disease management are exempt from the last two, as those are already mandated for that program.
  • https://www.beckershospitalreview.com/healthcare-information-technology/digital-health/cms-launches-digital-health-app-library-for-medicare-beneficiaries/

KEY MEDTECH NEWS

A provocative proposal asks the FDA to let some AI devices on the market without review

  • The Trump administration has promised to reduce the barriers between health artificial intelligence developers and patients. With a provocative new proposal, an AI company has offered regulators a way to let a broad swath of potentially risky AI devices flood the market.
  • AI developer Harrison.ai last October petitioned the Food and Drug Administration to allow manufacturers to release certain new AI products radiologists use to analyze medical images without review, provided the FDA has previously cleared a relevant product from a company. AI developers would also need to follow certain technical standards and offer a plan for how to keep tabs on the product’s performance.
  • The FDA allows anyone to submit a petition asking for devices to be exempted from review, but it happens rarely.
  • The agency must respond within 180 days, and if it does not deny Harrison.ai’s proposal by mid-April, it will go into effect.
  • At the same time it’s considering the petition, the FDA announced that it had appointed a former senior executive from a Harrison.ai subsidiary to direct the office that informs agency policy on AI.
  • https://www.statnews.com/2026/02/23/harrisonai-fda-petition-exempt-ai-devices-premarket-review   (subscription required for full text)

KEY ACRONYMS

  • ACIP = Advisory Committee on Immunization Practices

  • ARPA-H = Advanced Research Projects Agency for Health
  • CBO = Congressional Budget Office
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CRUSH = Comprehensive Regulations to Uncover Suspicious Healthcare
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • GLOBE = Global Benchmark for Efficient Drug Pricing Model
  • GUARD = Guarding U.S. Medicare Against Rising Drug Costs
  • HELP = Senate Committee on Health, Education, Labor and Pensions
  • HHS = Department of Health and Human Services
  • HRSA = Health Resources and Services Administration
  • MA = Medicare Advantage
  • MAHA = Make America Healthy Again
  • NIH = National Institutes of Health
  • PROSPR = PROactive Solutions for Prolonging Resilience
  • VA = Department of Veterans Affairs
  • VFW = The Veterans of Foreign Wars of the U.S.

 

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