On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more
8/4/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Covered Entities ,
Drug Pricing ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Pilot Programs ,
Public Comment ,
Rebates ,
Reporting Requirements ,
Section 340B
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance memorandum on the Medicare Drug Price Negotiation Program (Negotiation Program) created by the Inflation Reduction Act of 2022...more
On February 14, 2023, the U.S. Department of Health and Human Services (HHS) published a report identifying three models that the Center for Medicare & Medicaid Services’ (CMS) Center for Medicare & Medicaid Innovation (CMMI)...more
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance addressing the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how...more
2/24/2023
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Inflation Adjustments ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Prescription Drugs ,
Proposed Guidance ,
Rebates ,
Section 340B
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance on the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how Medicare...more
The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...more
1/27/2023
/ Biologics ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Medicare Part B ,
Medicare Part D ,
Negotiations ,
OMB ,
Prescription Drugs ,
Public Comment
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more
8/5/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Funding ,
Medicaid ,
Medicaid Drug Rebate Program ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B
On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memo limiting Medicare coverage for Biogen’s new Alzheimer’s drug, Aduhelm. Under...more
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
11/5/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Failure to Report ,
False Claims Act (FCA) ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Physician-Owned Distributors ,
Physicians ,
Settlement Agreements ,
Sunshine Act
The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more
7/28/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Delays ,
Health Care Providers ,
Open Payments ,
Ownership Interest ,
Physician Fee Schedule ,
Physician-Owned Distributors ,
Physicians ,
Proposed Rules ,
Public Comment ,
Short-Term Loans ,
Sunshine Act ,
Teaching Hospitals