Medicaid AMP Final Rule Not Expected Until 2013, CMS Official Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Pharmaceutical industry stakeholders could have to wait another year before Medicaid details how to calculate average manufacturer prices for drugs and drug rebates and how to handle other complex issues from the Affordable Care Act.
You may also be interested in...
“Bona Fide Service Fees” Lawsuit Underscores Need For Care In Distributor Contracts, Medicaid AMP Calculations
Litigation being pursued by former drug wholesale association exec alleges that manufacturers inappropriately classed bona fide service fees as discounts, causing them to report inaccurate average manufacturer prices to CMS.
BIO, PhRMA Urge Delay In Part B Drug Price Substitution Policy Until AMP Reg Finalized
BIO and PhRMA urge CMS to delay making reimbursement rate substitutions for Medicare Part B drugs based on comparing ASP to AMP until the agency finalizes its rules on the methodology for calculating AMP. The final AMP rule is expected in 2013.
Generic Drug Firms Want CMS To Change Proposed Definition Of “Original NDA”
How CMS defines an “original NDA” for the purpose of rebate payments in its proposed Medicaid rule could mean some drugs currently charged at the generic drug rebate rate will soon be charged the higher brand drug rate.