February 26, 2016—The Centers for Medicare & Medicaid Services has sent state Medicaid agencies guidance on how to implement new final regulations governing Medicaid reimbursement for covered outpatient drugs, including those bought through the 340B drug discount program. [ms-protect-content id=”2799″]
CMS formally published the final regulation on Feb. 1 and sent the guidance letter to states on Feb. 11.
CMS said in the letter that states will have “four quarters from the effective date of the final rule with comment, which is April 1, 2016, to revise their [Medicaid] state plan and submit a SPA [a state plan amendment] with an effective date no later than April 1, 2017 to comply” with the rule’s provisions.
As CMS stated in the final regulation, the letter said that a state’s payment methodology for drugs dispensed by 340B covered entities and contract pharmacies “must be in accordance with the definition” of actual acquisition cost (AAC) in the final regulation. “For drugs purchased through the 340B program, reimbursement should not exceed the 340B ceiling price,” it continues.
The letter also repeats guidance CMS included in the preamble to the final rule. “In addition, in accordance with the requirements…of the final regulation, SPAs must comprehensively describe the payment methodology for reimbursement of drugs dispensed by 340B entities [and] 340B contract pharmacies…in accordance with the definition of AAC, as well as the payment methodology for how such entities are reimbursed,” CMS said. “The state should include in its SPA the reimbursement methodology that the state plans to use to establish the AAC reimbursement model – e.g., state survey, discounted published compendia pricing data, 340B ceiling price, etc., – and state how this methodology will be incorporated into its pharmacy reimbursement policies. The SPA should also specify the alternative methodology that will be used by the state for reimbursement in the case where a pricing methodology that represents an AAC model of reimbursement is not available for a specific drug for a specific time period. States are also encouraged to evaluate their professional dispensing fees for 340B entities [and] 340B contract pharmacies…”[/ms-protect-content]