Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304/304a)

Forms and Documents

Document Name	Status
Form CMS-304 Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304) Form	Modified
Form CMS-304a Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304A) Form	Modified
CMS-304a Instructions - Crosswalk [rev 07-19-11].doc Supplementary Document	2011-07-19
CMS-304a - Appendix A Crosswalk [rev 07-19-11].doc Supplementary Document	2011-07-19
CMS-304 Appendix A - Croswalk [rev 07-19-11].doc Supplementary Document	2011-07-19
CMS-304 Instructions - Crosswalk [rev 07-19-11].doc Supplementary Document	2011-07-19
CMS-304 & -304a Supporting Statement A [rev 07-19-11].doc Supporting Statement A	2011-07-19

IC Document Collections

IC ID	Document Title	Status
8261	Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304) Form	Modified
46422	Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304A) Form	Modified

ICR Details

OMB Control No: 0938-0676	ICR Reference No: 201107-0938-007
Status: Historical Active	Previous ICR Reference No: 201001-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304/304a)
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: 10/23/2011
	Date Received in OIRA: 07/20/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2014	36 Months From Approved	03/31/2013
Responses	4,044	0	3,820
Time Burden (Hours)	183,120	0	141,080
Cost Burden (Dollars)	0	0	0

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Abstract: Section 1927 of the Social Security Act requires drug manufacturers to enter into and have in effect a rebate agreement with CMS in order for States to receive funding for drugs dispensed to Medicaid recipients. Drug manufacturers must explain to States any rebate payment adjustments for the current quarter, and any prior quarters. The information is used to reconcile drug rebate payments made by manufacturers with the State invoices of rebates due.

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Authorizing Statute(s): Statute at Large: 21 Stat. 1927 Name of Statute: null
   PL: Pub.L. 111 - 148 2501(C) Name of Law: Patient Protection and Affordable Care Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 2501(C) Name of Law: Patient Protection and Affordable Care 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:
	76 FR 21370	04/15/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 40369	07/08/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304)	CMS-304	Reconciliation of State Invoice (ROSI)
Reconciliation of State Invoice and Prior Quarter Adjustment Statement (CMS-304A)	CMS-304a	Prior Quarter Adjustment Statement (PQAS)

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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	4,044	3,820	224	0	0	0
Annual Time Burden (Hours)	183,120	141,080	42,040	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: In accordance with the new reporting requirements established by the Patient Protection and Affordable Care Act, the State invoice is being revised to include a new column that will enable States to distinguish between fee-for service and managed care utilization. Consequently, form 304 and 304a are being revised to reflect a similar new field that will enable manufacturers to separately identify fee-for-service and managed care units. As a result, the burden estimate has been changed to reflect the increased time it will take manufacturers to complete the forms.

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Annual Cost to Federal Government: $0

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: 07/20/2011

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