Frequently Asked Questions

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)

Supplemental Links:

• 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.

Supplemental Links:

• 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.

Supplemental Links:

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

FAQ ID:94861

FAQ ID:92871

The Review Tool Report is a feature CPOCs, SRTs, Senior Reviewers, Package Approvers, Package Disapprovers, and CMS Report Admins can utilize to see Package Reviewable Units, Reviewers, Reviewable Unit Assessment Values, and Notes.

Log in as CMS Point of Contact or Submission Review Team member. Under the "Records" tab, select "Submission Packages". Then select the link to the submission package. In the left panel, select "Review Tool Report". You may sort the reviews of all Review Team members by Package Reviewable Unit, Reviewer, Reviewable Unit Assessment Value, or Note/Assessments by utilizing the drop-down boxes. You also have the ability to export this report to Excel by selecting "Export to Excel."

FAQ ID:92876

Analyst Notes are a form of brief internal communication for the CMS Review Team. These notes are a part of the official record; however, State users are not able to see these notes. Analyst Notes are part of the Review Tool for each Reviewable Unit and the SRT or CPOC may view the notes from other Review Team members (depending on the type of note) within the Review Tool, and add his/her own notes.

The CMS Point of Contact or Submission Review Team members may add Analysts Notes through the Review Tool. The types of notes available are referenced in a table below. You will start by logging in as the CMS Point of Contact or Submission Review Team member, then going to the "Records" tab. Under the "Records" tab select "Submission Packages" and then select the link to the package. In the left panel select "Analyst Notes". You will then have the ability to search notes entered by Review Team Members.

FAQ ID:92881

If certain fields are misaligned you may need to adjust your compatibility settings. Click the Tools button in the upper right side of your screen, and then click Compatibility View settings. Next click the Add button. The website is added to your Compatibility View and the screen will realign. You can always remove the website by clicking on the website in the list and clicking the Remove button. If an issue persists, please email the MACPro Help Desk at MACPro_HelpDesk@cms.hhs.gov

FAQ ID:92886

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