The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more
8/18/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
HRSA ,
Manufacturers ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Pilot Programs ,
Prescription Drugs ,
Rebates ,
Section 340B
The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more
7/29/2025
/ Drug Pricing ,
Health Insurance ,
Healthcare ,
Medicare ,
New Legislation ,
One Big Beautiful Bill Act ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Trump Administration
No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more
4/4/2025
/ Administrative Procedure Act ,
Appeals ,
Biden Administration ,
Bristol-Myers Squibb ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fifth Amendment ,
First Amendment ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs
The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more
5/15/2024
/ CA Supreme Court ,
Duty of Care ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Gilead Sciences ,
Healthcare ,
HIV ,
Life Sciences ,
Manufacturers ,
Negligence ,
Pharmaceutical Industry ,
Phase II ,
Product Defects ,
Summary Judgment
The U.S. Supreme Court clarified the standard for a defendant's state of mind in False Claims Act ("FCA") cases, holding that a defendant acts "knowingly"—which the FCA defines also to include deliberate ignorance and...more
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more
The Situation: The Supreme Court's ruling in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016), opened the door to more materiality defenses under the False Claims Act ("FCA"), but without making...more
3/4/2020
/ Defense Strategies ,
Deficit Reduction ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
False-Certification of Conformance ,
Materiality ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Relators ,
Summary Judgment ,
Universal Health Services Inc v United States ex rel Escobar