On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more
5/24/2024
/ Appeals ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more
5/13/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicare Part D ,
OIG ,
Patients ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements
On February 2, 2024, the “gang of six”—a bipartisan group of six senators who have traditionally championed reforms to the 340B program1 —introduced a discussion draft of a bill that would modify the program that provides...more
On January 30, 2023, the United States Court of Appeals for the Third Circuit issued its decision in Sanofi Aventis U.S. LLC v. United States Department of Health and Human Services, enjoining the United States Department of...more
On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more
12/7/2022
/ Comment Period ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Section 340B
Over the last two weeks we have seen a flurry of activity from U.S. District Courts across the country in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and HRSA, the agency responsible for...more
On October 13th our friends over at STAT broke the news [sorry, Paywall] about a “warranty” pilot program from Pfizer that offers both patients and health plans (including Medicare Part D plans) the opportunity to receive a...more
10/15/2021
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Medicaid ,
Medicare Part D ,
Patients ,
Pfizer ,
Pharmaceutical Industry ,
Pilot Programs ,
Prescription Drug Coverage ,
State Health Plans ,
Value-Based Purchasing
On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more
11/30/2020
/ Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Rulemaking Process ,
Stark Law ,
Trump Administration
On July 25, 2019 the Senate Finance Committee voted to advance their long-awaited drug pricing package to the Senate floor (we anticipate a Floor vote sometime this Fall). The Prescription Drug Pricing Reduction Act (PDPRA)...more
8/15/2019
/ Drug Pricing ,
Generic Drugs ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Proposed Legislation ,
Rebates ,
Risk-Sharing ,
Senate Finance Committee
I. Introduction -
In May 2018, the Department of Health and Human Services (HHS) introduced a “Blueprint” and Request for Information setting forth proposed actions and policies as a means to purportedly help lower...more