Frequently Asked Questions are used to provide additional information and/or statutory guidance not found in State Medicaid Director Letters, State Health Official Letters, or CMCS Informational Bulletins. The different sets of FAQs as originally released can be accessed below.
Frequently Asked Questions
AAC reimbursement requirements for covered outpatient drugs extend to retail community pharmacy providers where drugs are covered by Medicaid under the state's covered outpatient drug pharmacy benefit and are not reimbursed as part of a service. Physician-administered drugs are not required to meet AAC reimbursement requirements.
Supplemental Links:
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94701
The FULs represent an aggregate upper limit, which gives states flexibility to determine payment rates for individual drugs in accordance with the approved state plan. For drugs that have a FUL calculated, a state can use the calculated FUL price for reimbursement, or they can use another metric, such as an AAC, for reimbursement, as long as that metric will allow the state to remain within the FUL aggregate. Generally, we can say with certainty that if a state uses the NADAC to reimburse for those drugs that have a FUL calculated, the state will not exceed the FUL aggregate. However, if a state wants to use another AAC metric for reimbursement (other than NADAC) for drugs that have a FUL calculated, the state must demonstrate that its AAC metric will allow them to remain within the FUL aggregate. CMS will allow the states four quarters from the effective date of the final rule with comment, which is April 1, 2016, to revise their state plan, if necessary, and submit a SPA with an effective date no later than April 1, 2017, to comply with requirements of 42 CFR 447.512(b).
Supplemental Links:
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94711
As noted in the final rule with comment, we recognize that states may need to revise their state plans to accommodate the reimbursement provisions of the final rule and are allowing states four quarters from the effective date of the final rule to submit a SPA to comply with these provisions. However, states are required to implement pharmacy reimbursement limits, in the aggregate, in accordance with 42 CFR 447.512 and 447.514 as of the effective date of this final rule (81 FR 5310). CMS issued the first set of Affordable Care Act (ACA) FULs on March 29, 2016, and those FULs were effective on April 1, 2016.
Supplemental Links:
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94721
Not necessarily. In the case where a state is using the NADAC to meet the AAC reimbursement benchmark, for drugs that have a FUL calculated, states would generally not exceed the FUL aggregate. However, if a state uses another reimbursement benchmark to establish their AAC model of reimbursement, such as a state survey of retail prices, the state cannot assume that the FUL aggregate will not be exceeded.
Supplemental Links:
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94731
States are required to implement the limits set by the ACA FULs in their reimbursement methodologies as of the effective date of the final rule with comment, that is, April 1, 2016. The FULs are to be applied as an aggregate upper limit, so the states have flexibility to determine payment rates for individual drugs in accordance with the approved State plan, such that the total reimbursement for all drugs to which the FUL applies does not exceed the FUL in the aggregate. Many states have FULs as part of their ""lower of"" logic in their state plans already. While we recognize that many states will be using NADAC or their own AAC methodology, and many of these values will be below the FULs, we still ask that states include in their state plans, either as a part of their lower of methodology or in a separate entry or description in the state plan, how they intend to meet the FULs in the aggregate.
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94736
CMS will not publish a FUL price for a FUL product group where the agency does not have a corresponding NADAC to compare to the 175 percent of the weighted average of AMPs for the FUL product group. For further information please see the Methodology and Data Elements Guide on the Medicaid.gov website at on the Medicaid.gov website at https://www.medicaid.gov/Medicaid-CHIP-Program-Information/ByTopics/Benefits/Prescription-Drugs/Federal-Upper-Limits.html.
Supplemental Links:
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94741
States are required to apply the ACA FULs, in the aggregate, as of the effective date of the final rule with comment, that is, April 1, 2016. A SPA is not required to begin applying the ACA FULs in the aggregate.
Supplemental Links:
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94746
Pharmacy provider reimbursement rates should be consistent with efficiency, economy, and quality of care while assuring sufficient beneficiary access, in accordance with section 1902(a)(30)(A) of the Act. As states revise their reimbursement for the ingredient cost of a drug to stay within the FUL, they should also consider whether their current dispensing fee continues to provide adequate reimbursement for the cost of dispensing a prescription to a Medicaid beneficiary, as well as the need to submit a SPA. If a state determines that any change to reimbursement rates are needed, they are responsible for submitting a SPA demonstrating compliance with applicable requirements in the final rule with comment.
Supplemental Links:
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94751
A FUL will only be calculated when pharmaceutically and therapeutically equivalent multiple source drug products are available for purchase by retail community pharmacies on a nationwide basis (see 81 FR 5300, 5302-5304).
CMS plans to regularly monitor the availability of drugs by reviewing the FDA drug shortage list for drugs that have a FUL calculated, but are not likely to have enough supply in the market to meet current demand. Further, CMS plans to monitor weekly pricing changes available to us in the most current national survey of pricing to consider changes to the multiplier used to calculate the FULs, based on average retail community pharmacies' acquisition costs. It is also important to note that CMS currently publishes a monthly and weekly file of NADAC pricing values, which states can use to monitor those changes in average retail community pharmacies' acquisition costs as they apply the FUL aggregate reimbursement. CMS will not calculate a FUL for a given drug if the agency determines that there is a lack of availability of that drug to retail community pharmacies on a nationwide basis.
Supplemental Links:
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94756
The 340B ceiling prices can be calculated by the states using the formula in section 340B of the Public Health Service Act, which is based on the average manufacturer price (AMP) minus the unit rebate amount (URA).
Supplemental Links:
Date: July 6, 2016
Topics:
Prescription Drug Program
Subtopics:
Prescription Drug Program
FAQ ID: 94761