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Frequently Asked Questions

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.

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When computing monthly AMP, should manufacturers be calculating all the calculation components at the NDC-9 or just the smoothing components?

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

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If a manufacturer has a negative monthly AMP, should they use the most recent valid monthly AMP in the quarterly calculation?

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

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If a manufacturer is currently not selling to entities or providers located in Puerto Rico and the U.S. Territories, will they be required to sell covered outpatient drugs to the U.S. Territories going forward (April 2017)?

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

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FAQ ID:94856

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For smoothing of lagged price concessions and inclusion of sales from the U.S. Territories, should a manufacturer include the sales from the U.S. Territories in the 12 months of data for smoothing as of April 1, 2017 (going back to May 2016), or should they only include it in the smoothing only as of April 1, 2017 and prospectively?

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

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Regulations at 42 CFR 438.104(b) (1) (IV) prohibit Medicaid managed care plans from seeking to influence enrollment in their plan in conjunction with the sale or offering of "private insurance." Does this prohibit a carrier that offers both a qualified health plan (QHP) and a Medicaid managed care plan from marketing both products?

The regulation only prohibits insurance policies that would be sold ""in conjunction with"" enrollment in the Medicaid managed care plan. Section 438.104 alone does not prohibit a Medicaid managed care plan from providing information about a Qualified Health Plans (QHP) to potential enrollees who could enroll in such a plan as an alternative to the Medicaid managed care plan due to a loss of Medicaid eligibility or to potential enrollees who may consider the benefits of selecting an Medicaid managed care plan that has a related QHP in the event of future eligibility changes. However, Medicaid managed care plans should consult their contracts and the State Medicaid agency to ascertain if other provisions exist that may prohibit or limit such activity.

Section 438.104(b)(1)(iv) implements a provision in section 1932(d)(2)(C) of the Social Security Act, titled ""Prohibition of Tie-Ins."" In promulgating regulations implementing this provision, CMS clarified that we interpreted it to preclude tying enrollment in the Medicaid managed care plan with purchasing (or the provision of) other types of private insurance. We do not intend the statutory prohibition of tie-ins to apply to a discussion of a possible alternative to the Medicaid managed care plan, which a QHP could be if the consumer is determined to be not Medicaid eligible or loses Medicaid eligibility.

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FAQ ID:94351

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Do the terms of the contract between the State Medicaid agency and a Medicaid managed care plan apply to that organization's qualified health plan (QHP)?

States are encouraged to review their managed care contracts to clearly identify the legal entity with which they are contracted for Medicaid coverage since federal Medicaid managed care regulations do not address this aspect of contracting. If the party to the contract is an entity (such as a parent company) that has a contract with a state Medicaid agency to provide benefits as a Medicaid managed care plan and is also a QHP issuer, then some contractual provisions may apply to both. Although the federal Medicaid regulations do not apply to a QHP issuer or QHP, state law, regulation, or contract language may have implications for the QHP issuer. If changes are needed to narrow the scope of the contract to apply only to the Medicaid managed care plan, we encourage states to make those changes so as to ensure consistent understanding and application of the Medicaid contract terms.

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FAQ ID:94371

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If an individual who may already be enrolled in a Medicaid managed care plan, or is eligible to enroll in a Medicaid managed care plan, calls the plan's customer service unit with questions about that plan's Medicaid MCO and/or QHP products, can the Medicaid managed care plan answer consumer questions without violating the Medicaid marketing rules at 42 CFR 438.104?

Yes. Responding to direct questions from consumers is not generally a violation of 42 CFR 438.104. Proactive consumer inquiries to a health plan for information about coverage options, benefits, or provider networks is no different than a consumer obtaining information from the health plan's website. So long as the limits on marketing are satisfied and respected (e.g., the information is accurate and does not mislead, confuse or defraud beneficiaries or the state Medicaid agency), responding to direct questions from potential enrollees with accurate information is not prohibited.

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FAQ ID:94391

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May Medicaid managed care plans conduct outreach to their enrollees regarding the Medicaid eligibility renewal process?

There is no provision in 42 CFR 438.104 specifically addressing a Medicaid managed care plan's outreach to enrollees for eligibility purposes; therefore, it depends on the Medicaid managed care plan's contract with the state Medicaid agency. The federal regulation at 42 CFR 438.104 defines marketing as ""any communication, from an [Medicaid managed care plan] to a Medicaid beneficiary who is not enrolled in that entity, that can reasonably be interpreted as intended to influence the beneficiary to enroll in that particular [Medicaid managed care plan's] Medicaid product, or either to not enroll in, or to disenroll from, another [Medicaid managed care plan's] Medicaid product."" So long as information and outreach about the eligibility renewal process is neither directed to beneficiaries who are not enrolled with that Medicaid managed care plan, nor intended to influence the beneficiary to enroll in that particular Medicaid managed care plan-or to not enroll in, or disenroll from another Medicaid managed care plan-the activity is not within the scope of 42 CFR 438.104. Materials and information that purely educate an enrollee of that Medicaid managed care plan on the importance of completing the State's Medicaid eligibility renewal process in a timely fashion would not meet the federal definition of marketing. However, Medicaid managed care plans should consult their contracts and the state Medicaid agency to ascertain if other provisions exist that may prohibit or limit such activity.

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FAQ ID:94396

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