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    • ELECTRONIC HEALTH RECORDS—7th Cir.: Court remands consolidated hospital privacy breach lawsuit back to state court
    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Inadvertent omission of ‘medical director’ information on revalidation application grounds for enrollment and billing revocation, 10-year re-enrollment bar
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    • ADVERTISING (FOOD, DRUG & MEDICAL DEVICES)—N.D. Cal.: Henry Meds must collect ESI from cloud-based platforms
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    • CIVIL MONEY PENALTIES—NOTICES: No Adjustment to HHS Civil Monetary Penalty Amounts for 2026
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    • DRUGS AND BIOLOGICS—NOTICES: Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0
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    • END-STAGE RENAL DISEASE—OTHER AGENCY DOCUMENTS: HHS Kidney Care National Plan calls for competition, prevention, and transplant reform
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    • EXPERT INSIGHTS—FinCEN Targets $17.5 Billion In Suspected Health Care Fraud
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    • ORGAN PROCUREMENT AND TRANSPLANTATION—OTHER AGENCY DOCUMENTS: ASPE data brief shows health and economic benefits associated with increased kidney transplantation
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    • PRESCRIPTION DRUGS—FDA GUIDANCE NOTICES: Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability
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    Health Law Daily Wrap Up, ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Inadvertent omission of ‘medical director’ information on revalidation application grounds for enrollment and billing revocation, 10-year re-enrollment bar, (Oct 22, 2026)

    By Jeffrey H. Brochin, J.D.

    The plain language of 42 C.F.R. §424.535(a)(4) does not require any intent to deceive, rather it simply states that CMS may revoke when a provider “certified as ‘true’ misleading or false information on the enrollment application ...

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