Frequently Asked Questions

Effective April 1, 2016, each quarter, the labeler of the line extension drug should determine the initial brand name listed drug for its line extension drug taking into consideration which active initial drug has the highest additional rebate ratio for that quarter. Additionally, the labeler of the line extension drug needs to ensure that the NDC of the initial drug with the highest additional rebate ratio is updated in the Drug Data Reporting for Medicaid (DDR) system, as appropriate, each quarter.

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FAQ ID:94831

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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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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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

In qualifying states, certain United States Preventive Services Task Force (USPSTF) grade A or B preventive services and vaccine administration codes are eligible for a one percent FMAP increase under section 4106 of the Affordable Care Act (which amended sections 1902(a)(13) and 1905(b) of the Act). Some of these services may also qualify as a primary care services eligible for an increase in the payment rates under section 1202 of the Affordable Care Act. For these services the federal matching rate is 100 percent for the difference between the Medicaid rate as of July 1, 2009 and the payment made pursuant to section 1202 (the increase). The federal matching payment for the portion of the rate related to the July 1, 2009 base payment would be the regular Federal Medical Assistance Percentage (FMAP) rate, except that this rate would be increased by one percent if the provisions of section 4106 of the Affordable Care Act are applicable.

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FAQ ID:91076

Effective for dates of service on and after January 1, 2013 through December 31, 2014, states are required by law to reimburse qualified providers at the rate that would be paid for the service (if the service were covered) under Medicare. Most states and the District of Columbia will need to submit a Medicaid state plan amendment (SPA) to increase Medicaid rates up to this level. The Centers for Medicare & Medicaid Services (CMS) has issued a state plan amendment (SPA) preprint for the purpose of expediting review and approval of the primary care payment increase.

For dates of service starting January 1, 2013 qualified providers are entitled to receive the higher payment in accordance with the approved Medicaid state plan amendment. States may not have attestation procedures or higher fee schedule rates in place on January 1, 2013. In that event, providers will likely continue to be reimbursed the 2012 rates for a limited period of time. Once attestation procedures are in place and providers are identified as eligible for higher payment, the state will make one or more supplemental payments to ensure that providers receive payment for the difference between the amount paid and the Medicare rate. Qualified providers should receive the total due to them under the provision in a timely manner.

A state may draw federal financial participation for the higher payments only after the SPA methodology is approved.

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FAQ ID:91271

The statute specifies that higher payment applies to primary care services delivered by a physician with a specialty designation of family medicine, general internal medicine, or pediatric medicine. The regulation specifies that specialists and subspecialists within those designations as recognized by the American Board of Medical Specialties (ABMS) the American Osteopathic Association (AOA) or the American Board of Physician Specialties (ABPS) also qualify for the enhanced payment. Under the regulation, "general internal medicine" encompasses internal medicine and all subspecialties recognized by the ABMS, ABPS and AOA. In order to be eligible for higher payment:

1. Physicians must first self-attest to a covered specialty or subspecialty designation.
2. As part of that attestation they must specify that they either are Board certified in an eligible specialty or subspecialty and/or that 60 percent of their Medicaid claims for the prior year were for the Evaluation and Management (E&M) codes specified in the regulation. It is quite possible that physicians could qualify on the basis of both Board certification and claims history.

Only physicians who can legitimately self-attest to a specialty designation of (general) internal medicine, family medicine or pediatric medicine or a subspecialty within those specialties recognized by the American Board of Physician Specialties (ABPS), American Osteopathic Association (AOA) or American Board of Physician Specialties (ABPS) qualify.

It is possible that a physician might maintain a particular qualifying Board certification but might actually practice in a different field. A physician who maintains one of the eligible certificates, but actually practices in a non-eligible specialty should not self-attest to eligibility for higher payment. Similarly, a physician Board certified in a non-eligible specialty (for example, surgery or dermatology) who practices within the community as, for example, a family practitioner could self-attest to a specialty designation of family medicine, internal medicine or pediatric medicine and a supporting 60 percent claims history. In either case, should the validity of that physician's self-attestation be reviewed by the state as part of the annual statistical sample, the physician's payments would be at risk if the agency finds that the attestation was not accurate.

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FAQ ID:91276