Blog | 1/30/2026

Sharp Strategy Spotlight: January 30, 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 January 29, 2026. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

US conditions funding to global vaccine group on dropping mercury-based preservative from shots

  • The Trump administration has told global vaccine group Gavi to phase out shots containing the preservative thimerosal as a condition of providing the group with funding, a U.S. official and a Gavi spokesperson told Reuters.
  • Anti-vaccine groups, including one founded by U.S. Health Secretary Robert F. Kennedy Jr., have for decades claimed that thimerosal, a mercury-based preservative used in vaccines, is linked to autism and other neurodevelopmental disorders, despite many studies showing no related safety issues.
  • “Until a plan for removal of thimerosal-containing vaccines is developed and the plan initiated, the United States will withhold future new funding,” an official for the U.S. Department of Health and Human Services told Reuters.
  • The official would not comment on when the request was made, but claimed Gavi has so far refused to develop such a plan. A Gavi spokesperson confirmed the request to remove thimerosal from its portfolio, and said the group remained in contact with the U.S. government on the subject.
  • "While we very much hope to find a pathway to welcoming the U.S. back as a donor, any decision related to Gavi’s portfolio would require a decision by Gavi’s board and input from preceding governance committees, which will be guided by scientific consensus," the spokesperson said.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-conditions-funding-global-vaccine-group-dropping-mercury-based-preservative-2026-01-28/

Trump admin to expand foreign aid abortion ban to gender identity and DEI

  • Vice President Vance on Friday announced plans to block foreign aid for groups supporting gender identity and diversity programs, expanding an existing ban on organizations providing abortion-related services.
  • Why it matters: The broadened "Mexico City" policy — referred to as a global gag rule — affects more than $30 billion in foreign assistance to both foreign and domestic organizations.
  • Driving the news: In January 2025, President Trump reinstated the "Mexico City" policy, which cuts off U.S. global health funding to international organizations that provide legal abortion information, referrals or services.
    • The new rule uses the same policy toward groups that work with what the Trump administration calls "gender ideology," "discriminatory equity ideology" and DEI.
  • What they're saying: "We're going to start blocking every international GO that performs or promotes abortion abroad from receiving a dollar of U.S. money," Vance said during a March for Life event in Washington, D.C.
    • He said the policy expansion "to protect life, to combat DEI" and "radical gender ideologies" would pertain to "every non-military foreign assistance that America sends," amounting to a policy expansion that is "about three times as big as it was before."
    • A State Department spokesperson said in a Thursday statement, "President Trump continues to deliver on his promise to end woke foreign assistance."
  • The policy was first established under President Ronald Reagan in 1984. It has been rescinded and reinstated by subsequent administrations along party lines.
  • Analysis: https://www.axios.com/2026/01/23/trump-vance-mexico-city-abortion-foreign-aid   (subscription required for full text)
  • Federal Register: https://www.federalregister.gov/documents/2026/01/27/2026-01516/combating-gender-ideology-in-foreign-assistance

California becomes first state to join WHO disease network after US exit

  • California Gov. Gavin Newsom (D) announced just one day after the U.S. officially withdrew from the World Health Organization (WHO) that his state would become the first to join the organization’s Global Outbreak Alert and Response Network.
  • “As President Trump withdraws the United States from the World Health Organization, California is stepping up under Governor Gavin Newsom — becoming the first, and currently the only, state to join the WHO’s Global Outbreak Alert & Response Network (GOARN), strengthening public health preparedness and rapid response coordination,” Newsom’s office said in a statement.
  • This announcement comes just one day after the U.S.’s withdrawal from the WHO became official after nearly 80 years of membership, having been a founding member of the organization.
  • https://thehill.com/homenews/state-watch/5703447-who-gavin-newsom-california/

KEY FEDERAL GOVERNMENT NEWS

Partial government shutdown looms, threatening to stall health funding package, telehealth extensions

  • Six annual spending bills for the current budget year are awaiting action in the Senate this week, including a key appropriations package that would fund the Department of Health and Human Services through Sept. 30.
  • But the sweeping government funding package is now in peril as Senate Democrats vowed to oppose it in the wake of the shooting death of a Minneapolis man by federal immigration agents, which would trigger a partial government shutdown.
  • The number of agencies that would be affected by a shutdown remains unclear.
  • The House passed the HHS funding bill last Thursday, including Medicare telehealth and hospital-at-home extensions.
  • The Medicare telehealth flexibilities, including no geographic restrictions and expanded provider types, and hospital at home flexibilities will expire on January 30, following an extension in late 2025.
  • Unless Congress acts, restrictions on location and provider types will return on January 31.
  • Press: https://www.fiercehealthcare.com/providers/partial-government-shutdown-looms-threatening-stall-health-funding-package-telehealth

Kennedy resets US autism panel with new line-up of 21 members

  • U.S. Health Secretary Robert F. Kennedy Jr. on Wednesday remade a federal panel that guides national autism policy, naming a new slate of 21 members that includes some with ties to groups promoting unproven claims that link vaccines to autism.
  • Kennedy, a long-time anti-vaccine activist who has tied vaccines to autism and claimed that no vaccine is safe, said his appointees to the Interagency Autism Coordinating Committee bring decades of experience and would "deliver the answers Americans deserve."
  • A Health and Human Services Department official said the previous members' terms had ended and were not renewed, adding that the new appointments were made in line with long-standing procedures.
  • The appointments include Daniel Rossignol, a doctor who has promoted discredited autism treatments including chelation therapy, which removes heavy metals from the body, as well as John Gilmore, a co-founder of the Autism Action Network who has said his son became autistic after being vaccinated, Brownstone Institute fellow Toby Rogers, and Autism Health founder Tracy Slepcevic.
  • Press:  https://www.reuters.com/business/healthcare-pharmaceuticals/health-secretary-kennedy-names-19-new-members-us-autism-advisory-panel-2026-01-28/
  • HHS Press: https://www.hhs.gov/press-room/hhs-kennedy-appoints-new-interagency-autism-coordinating-committee.html

Makary’s priorities: Faster reviews, domestic manufacturing, and AI

  • US Food and Drug Administration (FDA) Commissioner Marty Makary said he wants to see the same sense of urgency given to Operation Warp Speed applied to the agency’s Commissioner’s National Priority Voucher (CNPV) program.
  • During a fireside chat at the CASSS Well-Characterized Biotechnology Products (WCBP) conference in Washington, DC on Wednesday, Makary also said that FDA plans to designate the first company in its PreCheck program this summer.
  • Makary likened the voucher program to Operation Warp Speed, the initiative to quickly deliver COVID-19 vaccines during the first Trump administration. “We saw with operation Warp Speed we were able to get to a decision quickly. I would like to see the same level of urgency that we saw as a regulatory body with Operation Warp Speed, when people were dying of COVID.” He said that this same approach can apply to diseases across multiple areas, including neurodegenerative diseases, cancer, and other debilitating conditions.
  • Makary stated that the pilot program is primarily aimed at expediting the reviews of the chemistry, manufacturing, and controls (CMC) portion of submissions while the therapies are being tested in clinical trials.
  • https://www.raps.org/news-and-articles/news-articles/2026/1/makary-s-priorities-faster-reviews,-domestic-manuf

Medicare Advantage Insurers Face New Curbs on Overcharges in Trump Plan That Reins in Payments

  • On Jan. 26, Centers for Medicare & Medicaid Services officials announced they planned to raise rates paid to health plans by less than a tenth of a percent for 2027, far less than the industry expected.
  • Some of the largest, publicly traded insurers, such as UnitedHealth Group and Humana, saw their stock prices plummet as a result, while industry groups threatened that people 65 and older could see service cuts if the government didn’t kick in more money.
  • But less noticed in the brouhaha over rates: CMS also proposed restricting plans from conducting what are called “chart reviews” of their customers. These reviews can result in new medical diagnoses, sometimes including conditions patients haven’t even asked their doctors to treat, that increase government payments to Medicare Advantage plans.
  • In a news release, CMS Administrator Mehmet Oz said curbing this practice would ensure more accurate payments to the plans while “protecting taxpayers from unnecessary spending that is not oriented towards addressing real health needs.”
  • “These proposed payment policies are about making sure Medicare Advantage works better for the people it serves,” Oz said.
  • Analysis: https://kffhealthnews.org/news/article/medicare-advantage-overcharging-chart-reviews-trump-federal-rate-hike/
  • CMS Press: https://www.cms.gov/newsroom/press-releases/cms-proposes-2027-medicare-advantage-part-d-payment-policies-improve-payment-accuracy-sustainability

CMS Makes Push to Maximize Donor Organs, Even the Imperfect Ones

  • Organs from medically complex donors would get more use as part of a proposed rule for greater federal government oversight of organ procurement organizations (OPOs).
  • The proposed rule, released Wednesday by the Centers for Medicare & Medicaid Services (CMS), would require OPOs to assess their performance in placing organs from older donors or donors with less-than-optimal health status, and when possible take action to improve their performance to help widen the pool of life-saving matches.
  • CMS explained that "medically complex" donors and organs would be defined as donors whose medical history require special considerations for organ placement. This could include organs donated after cardiac death or from individuals with elevated Kidney Donor Profile Index scores, for example.
  • "These definitions are linked to a proposed new [quality assurance] requirement that would assist OPOs in facilitating appropriate placement and utilization of these organs," according to CMS.
  • Press: https://www.medpagetoday.com/transplantation/transplantation/119637
  • Proposal Rule:  https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organizations-opos-conditions-coverage-revisions-cms-3409-p-proposed-rule

E.P.A. Promises a Ban on Animal Testing by 2035

  • The Environmental Protection Agency will stop using rabbits, mice, rats and other mammals to test the toxicity of chemicals by 2035, the agency said.
  • Lee Zeldin, the E.P.A. administrator, announced the new policy and said it revives an effort begun during President Trump’s first term. While some testing will still be required to meet legal obligations about the safety of chemicals, Mr. Zeldin said the agency has been working to adopt methods that do not involve animals.
  • “We are confident we will continue to find in the weeks and months ahead, new technologies, new alternative methods that allow us to reduce animal testing on something that might be required today but it may not be necessary just a few months from now,” Mr. Zeldin said.
  • The ban does not address fish or fish larvae.
  • Press: https://www.nytimes.com/2026/01/22/climate/epa-animal-testing-ban.html   (subscription required for full text)
  • EPA Press: https://www.epa.gov/newsreleases/administrator-zeldin-gets-epa-back-track-eliminate-animal-testing-after-biden-admin

Dozens of CDC databases aren't being updated — most related to vaccines, study finds

  • Nearly half of the databases that the Centers for Disease Control and Prevention used to update regularly — surveillance systems that tracked public health information like Covid vaccination rates and hospitalizations for respiratory syncytial virus — have been paused without explanation, according to new research.
  • The findings, published Monday in the journal Annals of Internal Medicine, indicate that at the start of 2025, the CDC maintained 82 databases that were updated at least monthly. But by the end of October, the study found, 38 had gone stale, with 34 showing no new entries at all in the previous six months.
  • Although the CDC is perhaps best known for issuing public health advisories and recommendations, the agency also plays a key role as a national record-keeper, tracking the spread of infections and uptake of vaccines in as close to real time as possible.
  • But the CDC appears to be backing away from that part of its work, the new research suggests. The study found that nearly 90% of the paused databases were related to vaccinations.
  • Press: https://www.nbcnews.com/health/health-news/cdc-databases-not-updated-vaccines-study-rcna255467
  • Article: https://www.acpjournals.org/doi/10.7326/ANNALS-25-04022

STAT’s D.C. Diagnosis newsletter: Another CDC departure

  • Sara Patterson, acting director of the CDC’s Public Health Infrastructure Center, told staff on Friday she planned to step down next month, according to an email obtained by Daniel Payne.
  • Patterson, who has been at the agency for 23 years, said she would be leaving federal service for a new opportunity. She acknowledged “this past year’s challenges” in her note to staff, saying they had only brought them “closer together.”
  • The office’s work may be familiar to Americans just a few years out from a pandemic — it includes coordinating strategies across state and local health departments that became crucial to the response to Covid-19. The office also oversees the grants that, over the weekend, were briefly paused.
  • Patterson and HHS officials did not respond to requests for comment about the departure.
  • https://www.statnews.com/2026/01/27/hhs-spending-bill-caught-up-in-ice-debate-government-shutdown   (subscription required for full text)

CMS seeks input on bolstering domestic supply chain

  • CMS has issued an advance notice of proposed rulemaking to gather public feedback on strategies to strengthen the U.S.-based supply chain for personal protective equipment and essential medicines.
  • The agency is considering options to encourage American-made procurement among Medicare-participating hospitals. These include a potential “Secure American Medical Supplies” designation and revised payment mechanisms to help offset the resource burden of domestic sourcing, according to a Jan. 26 news release.
  • CMS Administrator Mehmet Oz, MD, said the effort builds on lessons from the COVID-19 public health emergency, which exposed vulnerabilities in foreign-dependent medical supply chains. The agency is inviting comments from hospitals, manufacturers, suppliers and other stakeholders on designations, payment models and other policy tools to support a more resilient supply chain.
  • The comment period is open for 60 days through the Federal Register.
  • Press:  https://www.beckershospitalreview.com/supply-chain/cms-seeks-input-on-bolstering-domestic-supply-chain/
  • CMS Press: https://www.cms.gov/newsroom/press-releases/cms-seeks-public-input-strengthening-domestic-supply-chain-ppe-essential-medicines

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

HHS Will Allow Pharmacies to Boycott Lifesaving Drugs Used in Medication Abortion

NIH ends support for most human fetal-tissue research

  • The world’s largest public funder of biomedical research will no longer support studies that use human fetal tissue derived from elective abortions.
  • The US National Institutes of Health (NIH) will continue to fund research on fetal tissue from miscarriages and stillbirths, according to an announcement made on 22 January. But scientists note that fetal tissue from elective abortions is the main material for research, because tissue from other sources is generally not useful for studies.
  • “It’s clearly a political decision, not a scientific one,” says Lawrence Goldstein, a retired neuroscientist who was at the University of California, San Diego.
  • But it is also not a dead end for all such research, he adds: some scientists will turn to a much smaller pool of private funding in lieu of government grants. “Research is going to go ahead, [the decision is] just slowing it down,” Goldstein says.
  • The NIH says that it funded 77 projects involving human fetal tissue in the 2024 fiscal year, and that researchers can harness technological advances in alternative methods, such as computational biology and 3D cell cultures, to conduct their studies.
  • Press: https://www.nature.com/articles/d41586-026-00251-2
  • NIH Press: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-26-028.html
  • HHS Press: https://www.hhs.gov/press-room/nih-proposes-embryonic-stem-cell-research-shift-put-patients-first.html

Advocacy group files FOIA lawsuit to gain further clarity on Trump administration's MFN pricing deals

  • Consumer advocacy organization Public Citizen has filed a Freedom of Information Act (FOIA) lawsuit against the Department of Health and Human Services (HHS) and the Department of Commerce for failing to provide documents related to President Donald Trump’s most-favored-nation drug pricing policy.
  • The nonprofit filed the complaint in federal District Court in Washington, D.C., after it made unsuccessful attempts to acquire copies of MFN agreements made between the government agencies and pharmaceutical giants Eli Lilly and Pfizer.
  • In its lawsuit, Public Citizen cited language in Trump’s MFN announcement from Sept. 30 on the government’s deal with Pfizer, which said that the agreement would “provide every State Medicaid program in the country access to MFN drug prices on Pfizer products” and would guarantee “MFN prices on all new innovative medicines Pfizer brings to market.”
  • A spokesperson for the HHS said the agency does not comment on litigation.
  • Press: https://www.fiercepharma.com/pharma/public-citizen-files-foia-lawsuits-against-trump-administration-mfn-pricing-deals-pfizer
  • Complaint: https://www.citizen.org/wp-content/uploads/1-Complaint-1.27.2026.pdf

KEY BIOPHARMA NEWS

Botox, Trulicity among 15 drugs on new Medicare negotiations list

  • The Trump administration on Tuesday announced the 15 drugs selected to participate in the newest round of the Medicare Drug Price Negotiation Program, including the high-cost medications Botox and Trulicity.
  • This third cycle of negotiations is the first to include drugs payable under Medicare Part B, which are traditionally administered in clinical settings, in addition to the traditional Part D prescription drugs, according to a press release from the Centers for Medicare and Medicaid Services (CMS).
  • The selected medications treat a range of conditions, including cancer, psoriatic arthritis, and human immunodeficiency virus type 1 infection.
  • The drugs that treat cancer include Erleada, Kisqali, Lenvima and Verzenio; those that address chronic immune-system diseases include Cimzia, Cosentyx, Entyvio, Orencia and Xeljanz.
  • The list also includes Anoro Ellipta, used to treat chronic obstructive pulmonary disease, and Xolair, which treats allergies. Biktarvy, an HIV treatment, is on the list, along with Rexulti, for depression and schizophrenia, and Botox, which is used for neurological and other medical issues along with cosmetic reasons, which Medicare doesn’t cover.
  • Press: https://thehill.com/policy/healthcare/5709615-trump-administration-medicare-drug-negotiations/
  • CMS Press: https://www.cms.gov/newsroom/press-releases/cms-announces-selection-drugs-third-cycle-medicare-drug-price-negotiation-program-including-first

Paving the way for TrumpRx, HHS seeks to protect drugmakers from violating anti-kickback laws

  • With launch time potentially approaching for TrumpRx, HHS unveiled part of its plan to shield drugmakers from anti-kickback laws to allow them to sell their products on the new direct-to-consumer platform.
  • The guidance — released via a “special advisory” bulletin from the agency’s Office of Inspector General — seeks to give drugmakers confidence that they won’t violate federal anti-kickback laws by offering cheaper prices on the TrumpRx site for cash-paying patients who are currently enrolled in federal healthcare programs.
  • The notice “provides pharmaceutical manufacturers with assurance that they may sell prescription drugs directly to patients who choose to pay cash — including patients enrolled in federal health care programs — when the arrangement meets specific conditions,” HHS said in a statement. “These include ensuring the drug is not billed to Medicare, Medicaid, or other federal programs, is not used to market other federally reimbursable products, and is not tied to future purchases or referrals.”
  • But HHS is simultaneously seeking public comment on how to change its safe harbor regulations that currently prohibit pharma companies from providing “inducements to beneficiaries” for direct-to-consumer pricing programs, including those that will be available through TrumpRx.
  • Press: https://endpoints.news/hhs-seeks-to-protect-drugmakers-from-anti-kickback-laws-ahead-of-trumprx-launch/   (subscription required for full text)
  • HHS Press: https://www.hhs.gov/press-room/oig-clears-path-for-lower-cost-prescription-drugs.html
  • HHS Bulletin: https://oig.hhs.gov/documents/special-advisory-bulletins/11450/OIG--FINAL--Special-Advisory-Bulletin.pdf

Hospitals could earn more for buying US-made drugs, CMS proposes

  • The Trump administration’s Centers for Medicare & Medicaid Services is looking to incentivize hospitals to buy more domestically-produced drugs.
  • Under a proposed rule, hospitals purchasing more than 50% of domestic-made essential medicines and active pharmaceutical ingredients would receive additional payments from Medicare, potentially to the tune of hundreds of thousands of dollars.
  • CMS’ rulemaking, published Monday evening, offers an example of a hospital with total drug costs of about $2 million, with essential medicines representing an estimated 1% of those costs. If domestic essential medicines are about 12 times more costly than ones that are foreign-made, that hospital would receive an additional Medicare payment of $240,000.
  • The rulemaking asks for public comment on several related questions on the plan and CMS’ assumptions. Noting that most essential APIs are produced abroad and it may take time to onshore them to the US, CMS asks: “How can we encourage domestic final dosage form production without diminishing long-term demand signals for domestic API manufacturing?”
  • CMS also says it wants to know more about hospitals’ total costs for essential medicines, and if 1% is an accurate figure. It pointed to a review from the Administration for Strategic Preparedness and Response that found that domestic APIs are, on average, about 12 times more expensive than ex-US alternatives.
  • Press: https://endpoints.news/hospitals-could-earn-more-for-buying-us-made-drugs-cms-proposes/   (subscription required for full text)
  • CMS proposed rule: https://public-inspection.federalregister.gov/2026-01730.pdf

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Funding Standoff Jeopardizes PAMA Relief as Medicare Lab Cuts Loom

  • Clinical laboratories are once again facing near-term Medicare payment uncertainty as congressional negotiations over a must-pass spending package stall, putting temporary relief from PAMA-driven cuts at risk just days before new reductions are scheduled to take effect.
  • The American Clinical Laboratory Association (ACLA) is closely tracking bipartisan, bicameral negotiations tied to a broader government funding deal that includes provisions to delay further cuts to the Medicare Clinical Laboratory Fee Schedule (CLFS). The proposal would push back additional PAMA-related reductions until Jan. 1, 2027, and update the private payor data CMS uses to set future Medicare rates. Without action, lab test reimbursement rate cuts are scheduled to go into effect on Jan. 31.
  • https://www.darkdaily.com/2026/01/28/funding-standoff-jeopardizes-pama-relief-as-medicare-lab-cuts-loom/   (subscription required for full text)

HRSA Updates Cervical Cancer Screening Guidelines, Endorses HPV Self-Collection and Mandates Insurance Coverage by 2027

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

FDA drafts guidance on cuffless blood pressure measuring devices

  • The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has issued a draft guidance to assist manufacturers in submitting clinical performance testing to support premarket submissions for cuffless non-invasive blood pressure (BP) measuring devices.
  • FDA defines these products as “a non-invasive blood pressure measurement system that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through sensors.”
  • These devices are classified as Class II devices and are regulated under 21 CFR 870.1130 with the product code DXN.
  • Cuffless devices provide several advantages over traditional cuffed devices, including greater comfort and convenience, the ability to measure blood pressure without upper arm sizing or positioning, and the capability for continuous blood pressure monitoring over extended periods, according to an article titled “Cuffless Blood Pressure Measurement Devices: International Perspectives on Accuracy and Clinical Use” which appeared in the April 2025 issue of JAMA Cardiology.
  • Press: https://www.raps.org/news-and-articles/news-articles/2026/1/fda-drafts-guidance-on-cuffless-blood-pressure-mea
  • Draft Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cuffless-non-invasive-blood-pressure-measuring-devices-clinical-performance-testing-and-evaluation

Medicaid Technology Companies Pledge $600M in Savings to Support Community Engagement and Related State Medicaid System Improvements

KEY ACRONYMS

  • ACA = Affordable Care Act
  • ACIP = Advisory Committee on Immunization Practices
  • API = active pharmaceutical ingredient
  • CDC = Centers for Disease Control and Prevention
  • CDRH = Center for Devices and Radiological Health
  • CLFS = Medicare Clinical Laboratory Fee Schedule
  • CMS = Centers for Medicare & Medicaid Services
  • EPA = Environmental Protection Agency
  • FDA = Food and Drug Administration
  • FOIA = Freedom of Information Act
  • GAORN = Global Outbreak Alert & Response Network
  • HHS = Department of Health and Human Services
  • HRSA = Health Resources and Services Administration
  • MFN = most favored nation
  • NIH = National Institutes of Health
  • OPO = organ procurement organization
  • PAMA = Protecting Access to Medicare Act 
  • WFTC = Working Families Tax Cut
  • WHO = World Health Organization

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