Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)

Forms and Documents

Document Name	Status
Form CMS-376a DDR Quarterly Pricing Data (CMS-367a) Form	Modified
Form CMS-367d Supplemental Data Sheet (CMS-367d) Form	Modified
CMS-367 - Response to Comments.docx Supplementary Document	2021-02-26
CMS-367 - Supporting Statement A (2021 version 1).docx Supporting Statement A	2021-02-26

IC Document Collections

IC ID	Document Title	Status
8184	DDR Quarterly Pricing Data (CMS-367a) Form	Modified
246017	One-Time System Updates (CMS-367a, b, and c)	New
222507	Supplemental Data Sheet (CMS-367d) Form	Modified
222506	DDR Product Data (CMS-367c) Instruction	Modified
222505	DDR Monthly Pricing Data (CMS-367b) Instruction	Modified

ICR Details

OMB Control No: 0938-0578	ICR Reference No: 202102-0938-016
Status: Received in OIRA	Previous ICR Reference No: 201912-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/26/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2023
Responses	14,980	14,117
Time Burden (Hours)	558,980	536,670
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): Statute at Large: 19 Stat. 1927 Name of Statute: null
  

Citations for New Statutory Requirements: 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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 76577	11/30/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 10971	02/23/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
DDR Monthly Pricing Data (CMS-367b)	CMS-367b	Monthly Pricing Data
Supplemental Data Sheet (CMS-367d)	CMS-367d	Contact Information Sheet
DDR Product Data (CMS-367c)	CMS-367c	Product Data
DDR Quarterly Pricing Data (CMS-367a)	CMS-376a	Quarterly Pricing Data
One-Time System Updates (CMS-367a, b, and c)

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	14,980	14,117	0	749	114	0
Annual Time Burden (Hours)	558,980	536,670	0	17,976	4,334	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: In this 2020/2021 iteration we have adjusted the number of respondents (manufacturer participation increased from 743 to 749) and adjusted our labor rates to more recent BLS data. The combination resulted in an increase in our total time and total cost estimates. Our per response time estimates are unchanged. Effective July 1, 2021, we are updating to a new Medicaid Drug Programs (MDP) system which will now accept a delimited text file format, Comma Separated Values (.CSV), in addition to the current Text (.TXT) file format. We have also increased several file format data field sizes in order to accommodate the higher priced drugs that are entering the market. These changes in conjunction with numerous edits to verbiage are applicable to Forms CMS-304 and CMS-304a. This PRA package (0938-0676) is simultaneously being updated along with our two corresponding PRA packages (0938-0578 and 0938-0582), so that all the MDP file formats, field sizes, and verbiage will align across the MDRP. In this regard we added a one-time burden for each manufacturer to make any system updates to accommodate the updated field sizes and .CSV file formats for CMS-367a, CMS-367b, and CMS-367c. See section 15 for more details regarding the changes.

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Annual Cost to Federal Government: $2,000,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 02/26/2021

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