U.S. flag

An official website of the United States government

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.

Showing 51 to 60 of 65 results

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:

FAQ ID:94836

SHARE URL

For 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:

FAQ ID:94841

SHARE URL

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.

Supplemental Links:

FAQ ID:94846

SHARE URL

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)

Supplemental Links:

FAQ ID:94851

SHARE URL

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.

Supplemental Links:

FAQ ID:94856

SHARE URL

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.

Supplemental Links:

FAQ ID:94861

SHARE URL

How should a state that has a section 1915(c) home and community-based services waiver that is limited to EPSDT-age individuals but includes services related to Autism Spectrum Disorder (ASD) that are now available through the state plan respond to this policy clarification?

The ASD-related services should be provided through the Medicaid state plan for the EPSDT-eligible individuals, rather than the 1915(c) waiver. CMS will work with states to ensure that such services are able to be made available under the state plan. Accordingly, CMS with also work with states to remove the service from the 1915(c) home and community-based services waiver at the next amendment or renewal, whichever comes first.

Supplemental Links:

FAQ ID:93206

SHARE URL

Has CMS mandated Applied Behavior Analysis (ABA) services for children under 21 with Autism Spectrum Disorder (ASD)?

No. Applied Behavior Analysis (ABA) is one treatment modality for ASD. CMS is not endorsing or requiring any particular treatment modality for ASD. State Medicaid agencies are responsible for determining what services are medically necessary for eligible individuals. States are expected to adhere to long-standing EPSDT obligations for individuals from birth to age 21, including providing medically necessary services available for the treatment of ASD.

Supplemental Links:

FAQ ID:93211

SHARE URL

When will CMS begin to assess state compliance with coverage requirements for children with Autism Spectrum Disorder (ASD)?

There is no specific time frame for CMS review of state practices in this area. The CMCS Informational Bulletin released July 7, 2014 (see http://www.medicaid.gov/Federal-PolicyGuidance/Downloads/CIB-07-07-14.pdf (PDF, 143.2 KB)), related to Autism Spectrum Disorder discusses the obligations under the Medicaid statute and regulations that are already in effect. However, CMS recognizes that states may not have focused on the application of these requirements in this area. As a result, a state may need time to review its current program policies to determine if changes are needed to existing state regulations and/or policy to ensure compliance. States may also want to confer with the stakeholder community for public input on the benefit design of autism services for children. CMS believes states should complete this work expeditiously and should not delay or deny provision of medically necessary services. CMS is available to provide technical assistance to states to ensure the availability of services that children may need.

Supplemental Links:

FAQ ID:93221

SHARE URL

Do states need to submit a Medicaid state plan amendment (SPA) to offer benefits to individuals with Autism Spectrum Disorder (ASD)?

In order to have services reimbursed under the Federal Medicaid program, a service must meet the definition of a coverable service under section 1905(a) of the Social Security Act. Treatment for ASD is not specifically referenced as a section 1905(a) service. However, some treatment modalities, or components of such treatment modalities, are within the scope of the federal Medicaid program under the following service categories: section 1905(a)(6) Other Licensed Practitioner (OLP), section 1905(a)(13) Preventive Services, and section 1905(a)(11) Therapies :. States may provide services to address ASD under each of these benefit categories. States will need to determine what, if any, steps are needed to implement this policy clarification. In keeping with the role of the Medicaid state plan as a comprehensive written statement of the nature and scope of services available under the state's Medicaid program, a SPA is strongly encouraged to articulate the state's menu of services for ASD treatment.

Supplemental Links:

FAQ ID:93231

SHARE URL
Results per page