April 6, 2016—The Centers for Medicare & Medicaid Services is giving drug manufacturers a three-month extension to begin calculating and reporting, in accordance with new federal regulations, the average manufacturer price for “5i” inhalation, infusion, instilled, implanted or injectable drugs that are not generally dispensed through retail community pharmacies. [ms-protect-content id=”2799″]
CMS announced the delay, from April 1 to July 1, in a March 31 communication to drug manufacturers. The agency explained that “it has come to our attention that drug manufacturers may need additional time to complete system modifications” to calculate and report AMP for 5i drugs consistent with CMS’s covered outpatient drug final rule, aka the final AMP rule. Between now and July 1, manufacturers are still required to report monthly and quarterly 5i AMPs consistent with the final AMP rule, but may do so using reasonable assumptions, CMS said.
The 340B ceiling price is statutorily defined as AMP reduced by the Medicaid rebate percentage, commonly referred to as the unit rebate amount. [/ms-protect-content]