CMS Defines A “Line Extension” Drug, Formula For Calculating Rebates
As part of its proposed rule on Medicaid drugs, CMS offers a definition for a line extension drug, for which Medicaid rebate amounts were adjusted under the Affordable Care Act. The proposal reveals some challenges in identifying those drugs since rebate reports do not differentiate line extensions, prompting a process that involves cross-referencing with FDA drug approval data. CMS also offers a proposal on how to calculate rebates for line extension drugs.
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In the latest reminder of how badly industry lost the argument over the value of incremental improvements in formulations, US is proposing enhanced Medicaid rebates on virtually all new formulations of existing brands.
Calculating AMP: Medicaid Proposed Rule Provides Answers, Some Detailed, Some Vague, To Manufacturers’ Questions
Manufacturers seeking answers on how to comply with the law on calculating average manufacturer price for drugs in Medicaid can turn to CMS’ proposed rule on the topic, published in the Feb. 2 Federal Register. The rule addresses a wide range of issues, including how closely manufacturers must track sales to retail community pharmacies for reporting, how to define a “retail community pharmacy,” how to define “bona fide service fees” and fair market value for them, since they can be excluded from AMP, and how to identify “5i” specialty drugs not generally dispensed at a retail community pharmacy, since they have their own special rules for calculating AMP.
Food safety programs would get the largest increase in the White House’s proposed fiscal 2015 FDA budget, and increases in user fee programs are proposed as key drivers for the boost. The agency’s overall budget would grow $335 million to $4.7 billion in the proposal.