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
State Medicaid agencies are required to have MMIS System Security Plan and Privacy Impact Assessment documents. State Medicaid agencies must perform regular routine security and privacy risk assessments to ensure the protection and safeguard of beneficiary data that is consistent with Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules. Please refer to the MECT for more details: https://www.medicaid.gov/medicaid/data-and-systems/mect/index.html
Yes. While CMS envisions a discrete role for the System Integrator (SI) in each state, with specific focus on ensuring the integrity and interoperability of the Medicaid IT architecture and coherence of the various modules incorporated into the Medicaid system complex, it is permissible for an SI to provide modules as part of the overall solution. The target outcome for the SI in support of the state should be to foster best-in-breed solutions for Medicaid business requirements, with the SI responsible for the successful integration of the chosen solutions and infrastructure into a seamless functional system. The SI must ensure that all modules have open APIs and remain loosely coupled. More information on the SI role can be found in Section 1.7 of the Medicaid Enterprise Certification Life Cycle, part 01 of the MECT. States are encouraged to use an acquisition approach that limits the potential for conflict of interest an SI may have in choosing the modular solutions to be incorporated into the system. As described above, the goal is to avoid lock-in to a single vendor or an otherwise closed set of solutions.
CMS encourages the use of an SI outside the state agency, but states can consider themselves in that role if they can support that effort and if that decision is made with consultation and agreement from CMS. For more information about the role of the SI, see Section 1.7 in part 01 of MECT Medicaid Enterprise Certification Life Cycle. https://www.medicaid.gov/medicaid/data-and-systems/mect/index.html
All states are required to adopt the AAC and professional dispensing fee methodology; however, it is not required to be adopted at the individual claim level, but in the aggregate. In accordance with the regulatory requirements at 42 CFR 447.512(b), the state is responsible for establishing a payment methodology, that must not exceed, in the aggregate, payment levels that the agency has determined by applying the lower of the AAC plus a professional dispensing fee or the providers' usual and customary charges to the general public. In conjunction with this the state is also responsible to ensure that pharmacy reimbursement is consistent
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with the requirements of section 1902(a)(30)(A) of the Act, which specify that provider reimbursement rates should be consistent with efficiency, economy, and quality of care while assuring sufficient beneficiary access.If a state is already making payment for prescription drugs under its state plan based on AAC, it may continue to use that methodology. However, if a state decides to change its AAC model of reimbursement, (e.g., the state decides to use the National Average Drug Acquisition Cost (NADAC) instead of a state survey to implement a payment methodology based on AAC), the state must submit a new SPA through the formal SPA process for review.
Additionally, the state should review its currently approved professional dispensing fee (PDF) to determine if, in light of the regulation (42 CFR 447.518), the PDF needs to be revised and a SPA needs to be submitted. The state does not have to submit a new SPA to provide assurance that its dispensing fee is reasonable.
Furthermore, we expect that all states, even those currently operating under an AAC reimbursement methodology, will evaluate their current state plans to determine if a SPA will be required to comply with the reimbursement requirements (including, but not limited to, AAC, PDF, 340B and the federal upper limits (FULs)).
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No, CMS will not perform an annual review of PDFs; however, states must consider both the ingredient cost reimbursement and the PDF reimbursement when proposing changes to ensure that total reimbursement to the pharmacy provider is calculated in accordance with requirements of section 1902(a)(30)(A) of the Act.
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To the extent that a state is conducting a cost of dispensing survey, it should be a transparent, comprehensive, and well-designed tool that addresses a pharmacy provider's cost to dispense the drug product to a Medicaid beneficiary. States have the flexibility to set PDFs, including using national or regional data from another state and we do not require that a state use a specific standard or methodology such as a survey to do so.
Further, states are not required to use a specific formula or methodology such as a cost study or use an inflation update where cost studies are not conducted; however, the burden is on each state to ensure that pharmacy providers are reimbursed in accordance with the requirements in section 1902(a)(30)(A) of the Act. CMS will review each SPA submission against these standards (see 81 FR 5311).
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The intent of the new reimbursement methodology requirements is not necessarily to result in a cost neutral outcome. The requirements are to more accurately reflect the pharmacy providers' actual prices paid to acquire drugs and the professional services required to fill a prescription. Each state's AAC reimbursement methodology and proposed professional dispensing fee will be reviewed through the SPA process to ensure they are meeting the requirements of this final rule.
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The NADAC files have weekly updates posted on Medicaid.gov that reflect any price changes that have occurred since the last posted monthly file. States using the NADAC for their AAC reimbursement methodology will have access to the weekly updates of the NADAC to ensure pharmacies are reimbursed with the most updated NADAC pricing.
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AAC reimbursement requirements for covered outpatient drugs extend to retail community pharmacy providers where drugs are covered by Medicaid under the state's covered outpatient drug pharmacy benefit and are not reimbursed as part of a service. Physician-administered drugs are not required to meet AAC reimbursement requirements.