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 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report entitled, “Technical Assistance Brief: Implementation of Inflation-Indexed Rebates for Part B Drugs.” ...more
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 April 1, the Protecting Access to Medicare Act of 2014 was enacted into law (Pub. L. 113-93). Section 216, entitled Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, modernizes the Medicare payment...more