H.R. 1314, the Bipartisan Budget Act of 2015, was signed into law by President Obama on November 2, 2015. The two-year budget framework, which raises the federal debt limit through March 2017, partially rolls back the Budget...more
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more
10/26/2015
/ Affordable Care Act ,
Department of Health and Human Services (HHS) ,
Discounts ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
Interpretive Rule ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
PHSA ,
Prescription Drugs ,
Public Health Service Act ,
Section 340B
A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more
On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more
10/17/2014
/ Affordable Care Act ,
Ambulance Providers ,
Anti-Kickback Statute ,
CMP Law ,
Gainsharing ,
Healthcare ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmacies ,
Proposed Regulation ,
Safe Harbors