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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-367a DDR Quarterly Pricing Data Specifications (CMS-367a)	Form	Modified	Available
Form CMS-367d Supplemental Data Sheet (CMS-367d)	Form	New	Available
CMS-367 - Supporting Statement A [rev 07-17-2016 by OSORA PRA].docx	Supporting Statement A	Uploaded 2016-07-17	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
8184	DDR Quarterly Pricing Data Specifications (CMS-367a)	Form	Modified
222509	One-Time Cost of Training Drug Manufacturer Staff		New
222508	One-Time Reconfiguration of Labeler Drug Pricing Systems		New
222507	Supplemental Data Sheet (CMS-367d)	Form	New
222506	DDR Product Data Specifications (CMS-367c)	Instruction	New
222505	DDR Monthly Pricing Data Specifications (CMS-367b)	Instruction	New

ICR Details

OMB Control No: 0938-0578	ICR Reference No: 201607-0938-008
Status: Historical Active	Previous ICR Reference No: 201603-0938-023
Agency/Subagency: HHS/CMS	Agency Tracking No:
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/16/2016
	Date Received in OIRA: 07/20/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	36 Months From Approved	03/31/2019
Responses	12,810	0	12,810
Time Burden (Hours)	3,618,703	0	3,612,603
Cost Burden (Dollars)	0	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:
	81 FR 26235	05/02/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 44867	07/11/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

table that charts list of burden

IC Title	Form No.	Form Name
DDR Monthly Pricing Data Specifications (CMS-367b)	CMS-367b	DDR Monthly Pricing Data Specifications
DDR Product Data Specifications (CMS-367c)	CMS-367c	DDR Product Data Specifications
One-Time Cost of Training Drug Manufacturer Staff
One-Time Reconfiguration of Labeler Drug Pricing Systems
DDR Quarterly Pricing Data Specifications (CMS-367a)	CMS-367a	DDR Quarterly Pricing Data Specifications
Supplemental Data Sheet (CMS-367d)	CMS-367d	Supplemental Data Sheet

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	12,810	12,810	0	0	0	0
Annual Time Burden (Hours)	3,618,703	3,612,603	0	6,100	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The current ICR (approved April 4, 2016) had set out one IC. This July 2016 iteration breaks out the requirements and burden into six ICs. This is intended to provide a clearer picture of the components within this information collection request. The only program/burden change is specific to CMS-367c which adds 6,100 hours for the narrow exception process (see Supporting Statement section 15). There are no program/burden changes with regard to CMS-367a, CMS-367b, CMS-367d, the reconfiguration of labeler drug pricing systems, and the training of drug manufacturer staff.

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

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 07/20/2016

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