Posted: 02 Feb 2016 01:19 AM PST
By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons –
The February 1st Federal Register contained CMS’s final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). The rule had been released for prepublication review on January 21. This rule, which has an effective date of April 1, 2016, will require pharmaceutical companies to make substantial changes in their MDRP policies, procedures, calculation methodologies, and systems within a very short time frame. To help our readers understand the final rule and how to implement it, HP&M today released a memorandum summarizing the rule, which is available here.
Also, in collaboration with KPMG’s government pricing leaders, HP&M will conduct a free Webinar entitled “A Practical Guide the Medicaid Rebate Final Rule” on Friday, February 19 from 1:00 to 3:00 pm EST. For information about the Webinar and how to register for it, click here.
The final rule goes a long way toward clarifying ambiguities in the Affordable Care Act amendments to the Medicaid Rebate statute and CMS’ 2012 proposed rule, and contains a number of favorable changes from the proposed rule. Among the highlights are the following (page numbers refer to our summary memorandum):
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