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 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: A decision by the U.S. Court of Appeals for the Second Circuit reinforces the growing body of case law regarding the strict materiality requirements of the False Claims Act.
The Result: Coyne v. Amgen is...more
1/15/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Payment ,
Failure To Disclose ,
False Claims Act (FCA) ,
Health Care Providers ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Motion to Dismiss ,
Prescription Drugs ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar
The Situation: In Spay v. CVS Caremark Corp., the Third Circuit became the latest court of appeals to hold that, in False Claims Act litigation, scienter can be lacking when the government has knowledge of "the facts...more
11/28/2017
/ Acquiescence ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
False Statements ,
Government Knowledge Defense ,
Material Misstatements ,
Materiality ,
Medicare Part D ,
Prescription Drugs ,
Scienter ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar