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
Can you confirm that manufacturers of extended release formulations will have to calculate the alternative line extension AMP starting April 1, 2016, since extended release formulations are specifically mentioned in the statutory language that established the alternative line extension formula?
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).
Supplemental Links:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94836
SHARE URLFor the Affordable Care Act (ACA) Base Date AMP, does the recalculation only go back to 2Q 2016 or would it go back further due to the length of time it has taken for the Final Rule to be published?
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.
Supplemental Links:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94841
SHARE URLWhen 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.
Supplemental Links:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94846
SHARE URLIf 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)
Supplemental Links:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94851
SHARE URLIf 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.
Supplemental Links:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94856
SHARE URLFor 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.
Supplemental Links:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94861
SHARE URLDoes CMS MMIS certification support non-traditional claims processing models, such as using an Administrative Services Organization or "claims processing as a service" approach?
Yes. The certification checklist defines a set of business and technical requirements that a particular Medicaid function must meet. The checklists and criteria are agnostic as to whether the requirements are met by a system built within the Medicaid Agency, a Software-as-a-Service model, a cloud-hosted model, or an ASO model.
FAQ ID:94461
SHARE URLIs MITA considered during milestone reviews?
Yes, our milestone review process is fully aligned with MITA. During each milestone review, CMS will verify that the state has considered MITA maturity during system definition, and whether the state is actively moving toward higher MITA maturity as defined in the state's latest MITA State Self-Assessment. Please see 42 CFR 433.112 (b)(11).
FAQ ID:94476
SHARE URLI am a vendor not currently in the Medicaid space, but interested in learning more about opportunities for MMIS and/or E&E modular solutions. Whom can I contact for more information?
CMS is looking for new innovators in the Medicaid IT space. Please direct inquiries to: mmis_mes_certification@cms.hhs.gov.
FAQ ID:94416
SHARE URLI am an existing MMIS vendor under contract with a state. Who do I contact with questions about the new certification process?
Please work with your state representatives, so that they can contact CMS regional offices for quick assistance with your questions. In addition, please review other FAQs related to this topic.
FAQ ID:94431
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