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FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations

The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more

D.C. District Court Vacates 60-Day Medicare Advantage Overpayment Rule

The Situation: In 2016, several Medicare Advantage ("MA") organizations challenged a 2014 final rule promulgated by the Center for Medicare Services ("CMS") that broadly subjected MA organizations to potential liability under...more

Legislation, Lawsuit Cloud Future of 340B Program Payment Rate Reductions

The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more

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