Frequently Asked Questions

Effective April 1, 2016, each quarter, the labeler of the line extension drug should determine the initial brand name listed drug for its line extension drug taking into consideration which active initial drug has the highest additional rebate ratio for that quarter. Additionally, the labeler of the line extension drug needs to ensure that the NDC of the initial drug with the highest additional rebate ratio is updated in the Drug Data Reporting for Medicaid (DDR) system, as appropriate, each quarter.

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• This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)

FAQ ID:94831

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).

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• This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)

FAQ ID:94836

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.

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• This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)

FAQ ID:94841

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

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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• This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)

FAQ ID:94851

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

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• This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)

FAQ ID:94856

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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• This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)

FAQ ID:94861

A State may withdraw a submission package once it has been submitted to CMS. Withdrawing a submission package takes it out of contention and the submission package cannot be edited or resubmitted. Log in as State Point of Contact, and select the "Records" tab. Then select "Submission Packages" for your State. Next, select the link to the submission package you wish to withdraw. In the left panel, select "Related Actions". Next, select "Withdraw Submission Package". Then select the green button labeled "Withdraw Submission Package". A box will pop up, select "Yes". Once the submission package is withdrawn, you will be redirected to the Records screen. A yellow notification will appear briefly at the top of the page indicating "Action Completed Successfully".

FAQ ID:92891

After the State Editor has forwarded the submission package to the State Point of Contact for Reviewing, the State Point of contact should log into MACPro. Then go to the "Records" tab and select "Submission Packages" for your state. Select the submission package you wish for CMS to view. In the left panel, select "Related Actions". Next, select "Allow CMS to View Screen". On the Allow CMS to View Screen page, select "Yes" under Visibility Setting, and then select the green "Update Visibility" button in the bottom right corner.

Note: Selecting this option will permit the CMS review team to see the screens in this submission package as they are now. It does not cause the package to be submitted as Draft or Official, and does not start a CMS review clock. Validation of the screens is not required. Notify your CMS contact that viewing is available and who you wish to see it; MACPro does not notify CMS staff. You can deselect this option at any time.

FAQ ID:92896

Refer to the table below.

FAQ ID:92901