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
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:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94836
SHARE URLFor 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:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94841
SHARE URLWhen 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:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94846
SHARE URLIf 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:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94851
SHARE URLIf 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:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94856
SHARE URLFor 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:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
FAQ ID:94861
SHARE URLThis table indicates what reports are available to CMS Users. These can be found under the "Reports" tab.
|
Report Name |
Description |
Available For |
|
Clock Status Report |
View the regulatory clock statuses |
CPOC, CMS Disapproval Coordinator, SRT Admin CMS Report Admin, |
|
State Agency Profile Report |
Overview of a State's Medicaid Plan including the prior 12 months' submission package history |
CPOC, CMS Disapproval Coordinator, SRT Admin, CMS Report Admin, CSA, SRT |
|
Submission Detail Report |
View details on packages by date |
CPOC, CMS Disapproval Coordinator, SRT Admin, CMS Report Admin, SME, PA, PD,SRRVW, SRT |
|
Submission Statistics Detail Report |
View all Submission Packages currently in review |
CPOC, CMS Disapproval Coordinator, SRT Admin, CMS Report Admin, SME, PA, PD, SRRVW, SRT |
|
Submission Statistics Summary Report |
View summary of Submission Packages in a specific review status within a specified date range. |
CPOC, CMS Disapproval Coordinator, SRT Admin, CMS Report Admin, SME, PA, PD,SRRVW, SRT |
|
Submission Summary Report |
Overview of submitted packages by date |
CPOC, CMS Disapproval Coordinator, SRT Admin, CMS Report Admin, SME, PA, PD,SRRVW, SRT |
|
Staff Workload Report |
View the number of Submission Packages assigned to each CPOC and SRT member, as of the report run date. |
CMS Disapproval Coordinator, SRT Admin, CMS Report Admin, CSA |
FAQ ID:92871
SHARE URLWhat is the Review Tool Report?
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
SHARE URLWhat is the purpose of each Analyst Note Type?
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.
| Analyst Note Type | Description | Visible By |
| Note to self | Private note for self only | Self |
| For POC (Formal Review) | Indicates information that should be included in disposition | CPOC |
| For Review Team | For other Review Team members | CPOC and SRT |
| For RAI | Indicates something that requires RAI | CPOC and SRT |
| For Correspondence Log | Indicates information that should be communicated to the SPOC | CPOC and SRT |
| Non SRT-User | Note on behalf of a CMS participant outside of the Review Team | CPOC and SRT |
| General Note | A note that doesn't fall into another category | All |
| Justification | Provides bases for a recommended disposition | POC Admin, CPOC and SRT |
| Post-Recommendation | Included by other CMS users during the package disposition review | POC Admin, CPOC and SRT |
FAQ ID:92881
SHARE URLCertain fields within the reviewable units seem misaligned, how do I fix this issue?
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
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