Before the COVID-19 pandemic derailed even the best-laid plans, the Trump Administration and Congress were focused on a different public health issue: drug pricing. For years, President Trump has targeted “Big Pharma” as...more
President Trump has followed through on his threat to pharmaceutical manufacturers, signing new executive orders on Sunday that take a preliminary step toward the President’s goal of tying domestic drug prices to the prices...more
The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two...more
6/26/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicaid ,
OIG ,
Proposed Regulation ,
Proposed Rules ,
Safe Harbors ,
Trump Administration ,
Value-Based Purchasing
In response to the spread of COVID-19, on March 23, 2020, President Trump signed Executive Order 13910 (Order) to prevent the hoarding of health and medical resources necessary to respond to the spread of COVID-19 within the...more
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate...more
7/12/2019
/ Anti-Kickback Statute ,
Drug Pricing ,
Executive Orders ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Price Transparency ,
Proposed Rules ,
Safe Harbors ,
Secretary of HHS ,
Trump Administration
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and...more
7/24/2018
/ Anti-Kickback Statute ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more
5/14/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
REMS ,
Section 340B ,
Trump Administration
A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more
5/23/2017
/ Biologics ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
HCPCS ,
Healthcare Reform ,
Innovation ,
Legislative Agendas ,
Medicare ,
Medicare Part B ,
Obama Administration ,
Pharmaceutical Industry ,
Reimbursements ,
Rollbacks ,
Trump Administration
There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016. As we await the release of the final rule, the fate of this...more