Frequently Asked Questions

The requirements of the line extension provision of the final rule are effective as of the effective date of the final rule (April 1, 2016).

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

FAQ ID:94836

A manufacturer's recalculation of its ACA Base Date AMP value can be reported any time during the four quarters allowable period per the final rule with comment beginning 2Q 2016.

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FAQ ID:94841

In accordance with regulations at 42 CFR 447.510(d)(2), monthly AMP is calculated based on a weighted average of prices for all the manufacturer's package sizes (NDC 11) of each covered outpatient drug sold by the manufacturer during a month. It is calculated as the net sales divided by the number of units sold, excluding goods or any other items specifically excluded in statute or regulation. In accordance with the requirements of 42 CFR 447.510(d)(2)(iii) the smoothing of lagged price concessions occurs at the NDC-9 level as part of the monthly AMP calculation.

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

FAQ ID:94846

CMS has previously provided guidance regarding the reporting of zero or negative AMP in Manufacturer Release #80 (January 5, 2010) in which we specify that if a calculated monthly AMP is zero or negative, we recommend that manufacturers report the most recent prior month's positive AMP. However, the actual calculated monthly AMP should be used to calculate the quarterly AMP. If the quarterly AMP is zero or negative, we recommend that manufacturers report the most recent positive AMP value. Please see Manufacturer Release #80: https://www.medicaid.gov/Medicaid-CHIP-Program-Information/ByTopics/Benefits/Prescription-Drugs/Downloads/Rx-Releases/MFR-Releases/mfr-rel-080.pdf. (PDF, 127.6 KB)

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FAQ ID:94851

The final rule does not require that a drug manufacturer sell its drugs to certain purchasers.

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FAQ ID:94856

Given the one year delay in the effective date of the definitions of states and United States, manufacturers should begin using sales data in their smoothing process beginning with sales that occur as of April 1, 2017.

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FAQ ID:94861

States and their actuaries have flexibility in incorporating the Health Insurance Providers Fee into the state's managed care capitation rates. This fee is not unlike other taxes and fees that actuaries regularly reflect in developing capitation rates as part of the nonbenefit portion of the rate. CMS believes that the Health Insurance Providers Fee is therefore a reasonable business cost to health plans that is appropriate for consideration as part of the non-benefit component of the rate, just as are other taxes and fees.

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FAQ ID:91126

States have the flexibility to account for the Health Insurance Providers Fee on a prospective or retroactive basis. In the event that a prospective calculation results in a capitation rate that is too high or too low, the capitation rate may be adjusted after the actual tax assessment is known. States may also account for the fee prospectively by withholding such amounts until the health plan's actual fee is known. The capitation payment, net the amount of the withhold, must remain actuarially sound and the state can only claim Federal Financial Participation (FFP) on the actual expenditures paid from the withhold to reimburse the health plans for the fee.

States may account for the Health Insurance Providers Fee as an aggregated retroactive adjustment to the rates for the contract year once a health plan's liability is known. CMS anticipates that states would move to a prospective calculation as states and health plans obtain more experience with the fee.

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FAQ ID:91141

No. There is no Federal Financial Participation (FFP) available for Health Insurance Providers Fee payments made outside of actuarially sound capitation rates, per the requirements of section 1903(m)(2)(A(iii) of the Social Security Act and implementing regulations at 42 CFR 438.6(c)(2). Therefore, any payment for the fee-whether on a prospective or retrospective basis-must be incorporated in the health plan capitation rates and reflected in the payment term under the contract.

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FAQ ID:91151

There are reasonable ways to account for the Health Insurance Providers Fee as an adjustment to the states' capitation rates under either approach. In either approach, the amount of the fee should be incorporated as an adjustment to the capitation rates and the resulting payments should be consistent with the actual or estimated amount of the fee.

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• This FAQ was released as part of a larger set. View the full set. (PDF, 159.2 KB)

FAQ ID:91161