[Medicaid] Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)
Revision of a currently approved collection
No
Regular
06/29/2026
Requested
Previously Approved
36 Months From Approved
07/31/2026
16,160
15,742
606,932
591,042
0
0
Section 1927 of the Social Security Act (the Act) requires drug labelers to enter into and have in effect a rebate agreement with the Federal government for States to receive funding for drugs dispensed to Medicaid recipients. In order for payment to be made under Medicaid, the drug labeler must complete and sign a drug rebate agreement and fill in the information on the related documents. The drug manufacturer must also supply information within 30 days after the end of each calendar quarter and month on the average manufacturer price of the drugs.
Under the Medicaid program, states may provide coverage of prescribed drugs as an optional service under section 1905(a)(12) of the Social Security Act (the Act). Section 1903(a) of the Act provides for federal financial participation (FFP) in state expenditures for these drugs. Section 1927 of the Act governs the Medicaid Drug Rebate (MDR) Program and payment for covered outpatient drugs (CODs), which are defined in section 1927(k)(2) of the Act.
In general, for payment to be made available under section 1903(a) of the Act for CODs, manufacturers must enter into a National rebate agreement (agreement) as set forth in section 1927(a) of the Act. Section 1927 of the Act provides specific requirements for rebate agreements, drug pricing submission and confidentiality requirements, the formulas for calculating rebate payments, and requirements for states for CODs.
PL: Pub.L. 111 - 148 2503 Name of Law: Patient Protection and Affordable Care Act
PL: Pub.L. 111 - 226 202 Name of Law: Education Jobs and Medicaid Assistance Act
In this 202526 iteration we are proposing to revise CMS-367c (Product Data).
Using current data, we also have revised the number of respondents reporting drug information to CMS from 818 to 840; an increase of 22 participating labelers in the MDRP. Given that there are more respondents, the change has increased our total time and cost estimates. Our cost estimates have also increased by using more up to date wage figures. We are not proposing changes to any of our per response time estimates or to the frequency of reporting.
Overall, we estimate an increase of 418 responses and 15,890 hours.
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-376a Quarterly Pricing Data
Cover Page - mlv-stfh-69c3.pdf
CMS-367a-e - Supporting Statement A (2026 version 4).docx
DDR Quarterly Pricing Data (CMS-367a)