Manufacturers See AMP Rule’s “Presumed Inclusion” Proposal As Certainly Challenging
As manufacturers prepare comments on CMS’ proposed Medicaid pricing rule, areas of concern include the prohibition of “presumed inclusion” for drug sales to retail community pharmacies when calculating average manufacturer price, the definition of drug line extensions for rebate purposes, and definition of which drugs are “not generally dispensed through a retail community pharmacy.”
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Manufacturers must continue to use their discretion on which line extensions should be subject to inflation-based Medicaid rebates in lieu of guidance from CMS in its recent AMP final rule.
A major regulation that could reshape how the pharmaceutical industry reports drug pricing to the government and pays rebates on Medicaid drugs is slated to be released in final form in 2014. Some Medicaid regulatory experts suggest that CMS could make changes in the final rule that will make it less disruptive to manufacturers’ businesses than they have feared.
Amid Uncertainties, Acorda Preps For Next Phase Of ACA: An Interview With Managed Markets Head Kent Rogers
With nine months to go before key aspects of the Affordable Care Act are implemented, Acorda Therapeutics’ head of managed markets, Kent Rogers, says he, like everyone, is ‘learning.” Acorda expects to have a game plan ready by mid-summer on how it will adapt its commercial strategy to ACA-initiated changes. Rogers also points out that the company may be less affected than others in the near term because Medicare already covers the majority of patients who take its multiple sclerosis drug Ampyra.