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-367d Supplemental Data Sheet (CMS-367d)	Form	Modified	Available
CMS-367 - Supporting Statement A (2019 version 3).docx	Supporting Statement A	Uploaded 2019-12-13	Available

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0938-0578	ICR Reference No: 201912-0938-003
Status: Active	Previous ICR Reference No: 201607-0938-008
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/14/2020
	Date Received in OIRA: 12/13/2019
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	36 Months From Approved	02/29/2020
Responses	14,117	0	12,810
Time Burden (Hours)	536,670	0	3,618,703
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:
	84 FR 44316	08/23/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 61910	11/14/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
One-Time Reconfiguration of Labeler Drug Pricing Systems
DDR Monthly Pricing Data Specifications (CMS-367b)	CMS-367b	Monthly Pricing Data
Supplemental Data Sheet (CMS-367d)	CMS-367d	Contact Information Sheet
One-Time Cost of Training Drug Manufacturer Staff
DDR Product Data Specifications (CMS-367c)	CMS-367c	Product Data
DDR Quarterly Pricing Data Specifications (CMS-367a)	CMS-376a	Quarterly Pricing Data

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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	14,117	12,810	0	2,527	-1,220	0
Annual Time Burden (Hours)	536,670	3,618,703	0	89,967	-3,172,000	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: In this iteration, two fields (ACA Base AMP and DRA Base AMP) are being removed from Form 367c because the fields are no longer collected. We also propose to remove two one-time requirements. Additionally, several data definitions as well as verbiage have been updated on all the forms (367a-d) in order to provide better clarification for labelers. We have also adjusted the number of respondents due to an increase in the number of participating labelers. Overall, our total time estimate has decreased by -3,082,033 hours from our active estimate of 3,618,703 hours to our proposed estimate of 536,670 hours (see section 15 of this Supporting Statement for details).

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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? 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: 12/13/2019

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