Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
06/30/2023
36 Months From Approved
06/30/2023
234
0
234
12,101
0
12,101
0
0
0
Section 1927 of the Social Security Act requires each State Medicaid agency to report quarterly prescription drug utilization information to drug manufacturers and to CMS via form CMS-R-144. As part of this information, the State Medicaid agencies are required to report the total Medicaid rebate amount they claim they are owed by each drug manufacturer for each covered prescription drug product each quarter.
This 2020 information collection request is associated with our June 19, 2020, proposed rule (CMS-2482-P, RIN 0938-AT82).
Under proposed § 447.511(b) states, territories, and the District of Columbia would be required to ensure by certification that the quarterly rebate invoices sent to manufacturers that participate in the MDRP no later than 60 days after the end of each rebate period via CMS-R-144 (Quarterly Medicaid Drug Rebate Invoice), mirrors the data sent to us.
Under proposed § 447.511(d) states would now be required to certify that their SDUD meets the requirements specified under proposed § 447.511(e) via a certification statement. We believe the certification would not impose a significant burden as we will provide systems access to state certifiers to log in once per quarter to certify their SDUD report. Certifiers would have to apply for a CMS user ID and password, and keep current with required annual computer-based training, as current state staff with access to our systems must do. To comply with the proposed certification requirements, States must already have system edits in place to find and correct SDUD outliers prior to reporting to manufacturers and CMS.
We estimate it would take 5 hours for the State Medicaid Director, Deputy State Medicaid Director, another individual with equivalent authority, or an individual with directly delegated authority from one of the above to obtain current CMS systems access. In aggregate we estimate a one-time system ID/password access burden of 280 hours (5 hr x 56 respondents).
We also estimate an additional annual burden of 2 hours (or 30 minutes/quarter) for a chief executive to certify such data and to add the state data certification language in their submission. In aggregate we estimate a burden of 112 hours (2 hr x 56 respondents).
In addition to the changes associated with the proposed rule, we are also updating our cost estimates based on more recent BLS wage figures. Overall, our cost estimate has increased by $82,821 (from $615,526 to $698,347).
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form CMS-368 State Agency Contact Form (CMS-368)
CMS-368 and R-144 - Supporting Statement A (CMS-2482-P version 3).docx
State Agency Contact Form (CMS-368)