CMS has announced that it is delaying until July 1, 2016 enforcement of new rules regarding the determination of the average manufacturer price (AMP) for inhalation, infusion, instilled, implanted or injectable drugs (“5i drugs”) that are not generally dispensed through retail community pharmacies. The 5i policy, which was included in CMS’s February 1, 2016 Medicaid covered outpatient drugs final rule with comment period, originally was scheduled to take effect on April 1, 2016. In a release to drug manufacturers, CMS states that “a transition period prior to enforcement will allow manufacturers additional time to make necessary modifications and test their systems to calculate and report the AMP for 5i drugs in accordance with the requirements established in the Final Rule.” The transition period applies specifically to the provisions of the rule that require the identification of 5i drugs (42 CFR 447.507) and the calculation of AMPs for 5i drugs (42 CFR 447.504). In the meantime, manufacturers still must timely report monthly and quarterly AMPs consistent with 42 CFR 447.510 as of April 1, 2016, “but may do so using reasonable assumptions.” Moreover, manufacturers will be responsible for recalculating and restating their monthly and quarterly AMPs back to April 1, 2016 once they have completed the necessary modifications to their systems to calculate and report AMP for 5i drugs.