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    • GENERAL HEALTH CARE NEWS—D. Ariz.: Court reconsiders Lanham action against Swedish test manufacturer
    • ADMINISTRATION OF FDC ACT—NOTICES: Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027
    • CONDITIONS OF PARTICIPATION—DAB DECISIONS: Appellate division affirms 12-year Medicare exclusion for Missouri physician who billed for unsupervised assistant physicians
    • ELECTRONIC HEALTH RECORDS—D. Minn.: Back surgery patient’s claims about targeted internet advertising dismissed in part, survive in part
    • EXPERT INSIGHTS—The Villages Health System $541.5 Million Settlement: A New Frontier In Medicare Advantage Risk Adjustment Enforcement
    • MEDICAL DEVICES—FINAL RULES: FDA classifies mechanical deviation device as class II device
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    • SKILLED NURSING FACILITIES—OIG REPORTS: CMS concurs that it could improve oversight of states’ contract surveyors for nursing homes
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    Health Law Daily Wrap Up, WORTH NOTING—Other Health Law litigation and regulatory developments, (Sep 14, 2026)

    By WK Editorial Staff

    A roundup of other items of interest to the Health Law community.

    REPRODUCTIVE HEALTH CARE—D. Kan.: The DOJ asked the court to enjoin a Kansas City school from allowing children to change their gender identity in their school records while keep ...

    By WK Editorial Staff

    A roundup of other items of interest to the Health Law community.

    REPRODUCTIVE HEALTH CARE—D. Kan.: The DOJ asked the court to enjoin a Kansas City school from allowing children to change their gender identity in their school records while keeping that information from parents (U.S. v. United School District No. 500, Wyandotte County, State of Kansas, No. 2:25-cv-02519 (D. Kan. Sept. 1, 2026)).

    GENERAL HEALTH CARE NEWS—S.D. Ohio: Consumers alleged Centene, the nation's largest insurer on the ACA exchange, failed to provide an accurate and up-to-date directory of in-network providers as required by the ACA (Duff v. Centene Corp., No. 1:19-cv-00750-JPH (S.D. Ohio Aug. 28, 2026)).

    PRODUCTS LIABILITY (DEVICES)—S.D.N.Y.: The court granted a motion to preclude the testimony of a board-certified orthopedic surgeon who would testify that the components of a hip prosthesis were a defective design and manufactured in a defective manner (In re Zimmer M/L Taper Hip Prosthesis or M/L Taper Hip Prosthesis with Kinectiv Technology and Versys Femoral Head Products Liability Litigation, No. 1:18-md-02859-JMF (S.D.N.Y. Aug. 28, 2026)).

    FOOD—N.D. Cal.: Consumers allege product labels overstate the amount of protein in protein bars falsely claim that they contain 15-19 grams of protein per serving (Sullivan v. Built Brands LLC, No. 4:24-cv-04565-JST (N.D. Cal. Aug. 24, 2026)).

    PRODUCTS LIABILITY (DEVICES)—W.D. La.: The court denied a motion to dismiss claims alleging a patient died during a trans-aortic valve replacement surgery due to protruding valve struts on the valve being implanted which damaged the aortic wall (Broussard v. Edwards LifeSciences LLC, No. 26-cv-02477 (W.D. La. Sept. 1, 2026)).

    ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: The Board reopened an appeal to correct the administrative record after finding that the Provider timely responded to the Order to Show Cause concerning the ALJs dismissal of the Providers request for an ALJ hearing, but denied the motion to vacate the dismissal because the request for Board review was untimely. The Board also found that the Provider did not make the necessary showing under 42 C.F.R. 498.83(b)(2) because reliance on a third-party consultant's failure to meet filing deadlines did not constitute good cause, as the failure resulted from an internal breakdown and not circumstances beyond the Providers control. (Mega Hospice Services, DAB No. A-26-1, Ruling No. 2026-18 (Aug. 10, 2026)).

    GENERAL HEALTH CARE NEWS—OCR LETTERS: HHS Office for Civil Rights issues guidance on discrimination rooted in antisemitism in healthcare settings (OCR Letter, (Sept. 3, 2026)).

    GENERAL HEALTH CARE NEWS—CBO REPORTS: The effects of changing temperatures on the medicare population (CBO Report, (Sept. 8, 2026)).

    GENERAL HEALTH CARE NEWS—GAO REPORTS: Federal Rulemaking: Agencies continue to use good cause and other mechanisms to forgo public comments (GAO Report, No. GAO-26-108208 (Sept. 4, 2026)).

    HEALTH CARE REFORM—ASPE NEWS: Aligning Initiatives to End the HIV Epidemic in the United States (ASPE Report, (Sept. 8, 2026)).

    ORGAN PROCUREMENT AND TRANSPLANTATION—OIG REPORTS: Conflicting CMS guidance and federal statutory requirements cost Medicare $380 million over a 6-year period for organs not transplanted into Medicare enrollees (OIG Report, No. OAS-25-07-124 (Sept. 3, 2026)).

    MainStory: CaseDecisions DABDecisions GAOReports OIGReports CBOReports CMSNews FoodNews GeneralNews HealthReformNews MDeviceNews OrganNews PLDeviceNews ReproductiveHealthCareNews

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