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.
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)