It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
8/7/2024
/ Delisting ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Robinson-Patman Act
While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more
8/30/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Contract Negotiations ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Excise Tax ,
FTC Act ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Preliminary Injunctions ,
Prescription Drugs ,
Section 340B ,
Transparency
Despite a busy 2022, drug pricing remains a hot topic at the federal and state levels, with a number of recent developments and trends worth monitoring heading into 2023. In the past year, the FTC increasingly focused on the...more
1/10/2023
/ Biden Administration ,
Drug Pricing ,
Enforcement ,
Federal Trade Commission (FTC) ,
FTC Act ,
Inflation Reduction Act (IRA) ,
Investigations ,
Legislative Agendas ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Regulatory Agenda
Federal efforts on drug pricing are increasingly focusing on the role of pharmacy benefit manager middlemen. A recently proposed Senate bill seeks to eliminate certain PBM practices, such as spread pricing and unfair claw...more
New challenges may lie ahead for the pharmaceutical industry -
What’s next for drug pricing in the US?
Proposals to alter antitrust and patent laws may signal a renewed focus on drug pricing by federal lawmakers,...more
On December 10, 2020, the Supreme Court in Rutledge v. Pharmaceutical Care Management Association held that ERISA does not pre-empt an Arkansas law regulating PBM prescription drug payment rates to pharmacies because it...more
12/23/2020
/ 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
The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more
12/4/2020
/ Anti-Kickback Statute ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Final Rules ,
Medicare Part D ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Safe Harbors ,
Trump Administration
On September 13, 2020, President Trump issued an Executive Order seeking to establish most favored nation ("MFN") pricing for Medicare drug payments. The Trump Administration's Order, 'Lowering Drug Prices by Putting America...more
9/16/2020
/ Anti-Kickback Statute ,
Drug Pricing ,
Executive Orders ,
Imports ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Secretary of HHS ,
Trump Administration
While drug pricing continues to be an important political issue in the United States, it has been state legislatures, not the federal government, that have been able to translate policy proposals into new laws.
Over the...more