If an organization is performing another role (such as systems integrator, PMO, quality assurance, etc.) on the MMIS or E&E project, it may not perform the IV&V function on the same project. A state may contract the same vendor to perform the IV&V role for both its E&E and MMIS projects.
As contained in the MECT standard RFP/contract language required by CMS, CMS does not cover activities that the state may require of the IV&V contractor during ongoing O&M. However, as Medicaid is moving away from monolithic single applications, it is expected that states will continuously update and replace modules in their enterprise. Therefore, IV&V should always have a role to ensure successful integration and testing.
For E&E and MMIS, enhanced FFP funding is available at 90 percent via the usual Advanced Planning Document process.
MARS-E 2.0 compliance is not required by CMS for states' MMIS, but CMS recommends that states follow applicable national privacy and security standards and practices for their MMIS. MARS-E 2.0 compliance is required for states' Medicaid/CHIP Eligibility and Enrollment (E&E) systems in order to maintain their Authority to Connect with CMS.
IV&V contractor activities must still be performed such as checklist evaluation, artifact review and preparation of IV&V Progress Reports. The state should provide a plan and timeline for how these activities will be supported and performed until the proper IV&V contract can be either procured or aligned with updated CMS guidance on IV&V.
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.
The final rule does not require that a drug manufacturer sell its drugs to certain purchasers.
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.
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.
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.
