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

Forms and Documents

Document Name	Status
CMS-367 Supporting Statement.doc Supporting Statement A	2010-10-01

IC Document Collections

IC ID	Document Title	Status
8184	Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 Instruction	Modified

ICR Details

OMB Control No: 0938-0578	ICR Reference No: 201010-0938-001
Status: Historical Active	Previous ICR Reference No: 200707-0938-008
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: 11/05/2010
	Date Received in OIRA: 10/01/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2013	36 Months From Approved	11/30/2010
Responses	9,280	0	8,640
Time Burden (Hours)	137,344	0	127,872
Cost Burden (Dollars)	10,000	0	6,393,600

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Abstract: Section 1927 requires drug manufactures 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 fillin the information on the related documents. The Affordable Care Act (ACA) added two new data elements to potentially be reported by manufacturers, a Pediatric Exclusivity product indicator and a new optional "ACA base AMP" field. Additionally, per the ACA, the Federal upper limit (FUL) will be calculated as no less than 175 percent of the weighted average of the most recently reported monthly AMP. Section 1927 of the Act requires manufacturers to report the total number of units that are used to calculate monthly AMP for each covered outpatient drug no later than 30 days after the last day of the month. We plan to require manufacturers to report these units by the same unit type used to calculate the AMP and to use these units to calculate the weighted-AMP-based FULs prices.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AO20	Final or interim final rulemaking	72 FR 12345	07/17/2007

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 34740	06/18/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 60759	10/01/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534	CMS-367	CMS Record Specifications DDR

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ICR Summary 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	9,280	8,640	0	640	0	0
Annual Time Burden (Hours)	137,344	127,872	0	9,472	0	0
Annual Cost Burden (Dollars)	10,000	6,393,600	0	0	-6,383,600	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: The number of manufacturers has risen from 540 to 580; therefore, the annual hour burden has risen. The three new fields will not result in an additional reporting burden. The first is so minimal that it is not quantifiable, and the second is an optional, one-time entry that may be made on-line. The manufacturer units are already tracked by manufacturers as they are used to calculate the monthly AMP. Manufacturers have stated that there would not be an ongoing burden to submit after systems changes are incorporated.

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Annual Cost to Federal Government: $750,000

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: 10/01/2010

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