When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators....more
On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other...more
8/16/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Prescription Drugs ,
Price Inflation ,
Rebates ,
Section 340B
In November 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule, “Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar...more
On November 3, 2023, the United States District Court for the District of South Carolina issued its decision in the long-running dispute between Genesis Health Care Inc., a federally qualified health center and 340B-covered...more
On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit (the “Tenth Circuit”) issued its decision in Pharmaceutical Care Management Association (PCMA) v. Mulready, one of the first major opinions to further define...more
8/31/2023
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
On May 11, the U.S. Senate Committee on Health, Education, Labor and Pensions (the “HELP Committee” or the “Committee”) passed a bipartisan bill to expand federal regulation of pharmacy benefit managers (“PBMs”) for group...more
The Centers for Medicare & Medicaid Services (CMS) recently issued initial guidance on how the agency expects the Medicare Drug Price Negotiation Program (the “Negotiation Program”) to operate. The Negotiation Program was...more
On June 7, 2022, the Federal Trade Commission (FTC) unanimously voted to initiate a study into how business practices employed by some pharmacy benefit managers (PBMs) may impact prescription drug pricing and patient access...more
Impact on Pharmacies, Part D Payors, Pharmacy Benefit Managers, and Drug Manufacturers -
On April 29, 2022, the Centers for Medicare and Medicaid Services (CMS) issued its final rule, Medicare Advantage and Part D Final...more
On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more
2/6/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Rebates ,
Request For Information ,
Safe Harbors
On November 26, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses” (“Proposed Rule”)....more
12/6/2018
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Gag Clauses ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules