CMS Final Rule Defining “Average Sales Price” Expected In 2007
This article was originally published in The Pink Sheet Daily
Executive Summary
The Centers for Medicare & Medicaid Services' interim final rule defining "average sales price" is expected to be replaced with a final rule in April 2007, HHS' semiannual regulatory agenda published in the June 28 Federal Register states
You may also be interested in...
Medicare Rx Implementing Regs Expected After July 4
CMS is understood to be nearing completion on Title II (Medicare Advantage) regs. However, the current plan is to release Title I (Medicare Part D) and Title II on the same day.
Average Sales Price Formula Closely Follows Medicare Rx Law
The ASP final rule is scheduled to be published in the Federal Register April 6. CMS notes that the methodology may change in future years to include further price concessions.
U.S. Patents Could Limit President's AIDS Drug Assistance Plan, GAO Says
The U.S. Global AIDS Coordinator's Office suggests it will use its authority to purchase an FDA-approved generic antiretroviral product for which permission could not be obtained from the patent holder. FDA grants tentative approval to a South African firm for a generic co-packaged version of Combivir and Viramune.