As discussed in the final rule (81 FR 5250), if a specialty pharmacy meets the definition of a retail community pharmacy at section 1927(k)(10) of the Act, sales for such drugs would be included in AMP. This is true even in the event there are a low number of AMP eligible sales. Because CMS is permitting manufacturers to use a presumed inclusion approach when calculating AMP, and to make reasonable assumptions, an AMP will likely be generated for such drugs.

As noted in the comment and response in the preamble to the final rule (81 FR 5216), CMS declined to set a threshold in order to allow flexibility to recognize changes that take place in the pharmaceutical marketplace with regard to mail order business. CMS further noted that manufacturers may make reasonable assumptions that a pharmacy is a retail community pharmacy when the majority of the drugs are not dispensed through the mail. A "majority" is generally determined as greater than 50 percent, which could be interpreted as greater than 50 percent.

The provisions of this final rule related to pharmacy payments do not apply to MCO payment or reimbursement methodologies, including MCO providers participating in the 340B program.

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As stated in the above response, reimbursement to IHS and Tribal providers through the encounter rate is an option available to all states as a means to satisfying the requirement to reimburse such providers in accordance with the requirements at 42 CFR 447.518(a)(2).

Reimbursement to IHS and Tribal providers through the encounter rate is an option available to all states as a means to satisfying the requirement to reimburse such providers in accordance with the requirements at 42 CFR 447.518(a)(2).

Supplemental Links:

• This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)

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:

• This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)

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).

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.

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:

• This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)

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.