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

Forms and Documents

Document Name	Status
Form CMS-304a Prior Quarter Adjustment Statement (PQAS) (CMS-304A) Form	Modified
CMS-304_304a Supporting Statement A (2020 version 2).docx Supporting Statement A	2020-03-31

IC Document Collections

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

ICR Details

OMB Control No: 0938-0676	ICR Reference No: 202003-0938-011
Status: Active	Previous ICR Reference No: 201704-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: Reconciliation of State Invoice (ROSI) (CMS-304) and Prior Quarter Adjustment Statement (PQRS) (CMS-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: 06/23/2020
	Date Received in OIRA: 03/31/2020
Terms of Clearance: CMS shall display the OMB control number and expiration. In any future revision, extension, or reinstatement request for this collection, CMS shall detail how it is complying with the requirements at 5 CFR 1320.8(b)(3) for this collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved	06/30/2020
Responses	5,020	0	4,468
Time Burden (Hours)	227,416	0	202,384
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): PL: Pub.L. 111 - 148 2501(C) Name of Law: Patient Protection and Affordable Care Act
   Statute at Large: 21 Stat. 1927 Name of Statute: null
  

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:
	84 FR 67466	12/10/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 13163	03/03/2020
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 (ROSI) (CMS-304)	CMS-304	Reconciliation of State Invoice (ROSI)
Prior Quarter Adjustment Statement (PQAS) (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	5,020	4,468	0	0	552	0
Annual Time Burden (Hours)	227,416	202,384	0	0	25,032	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 this 2020 iteration our total time estimates have increased by 25,032 hours due to an increase in the number of respondents (manufacturer participation increased from 657 to 738). Although we are proposing minor updates to the punctuation, field names, and data definitions on forms CMS-304 and -304a, the changes are intended to align the forms with CMS-367 (OMB 0938-0578) and CMS-368/-R-144 (OMB 0938-0582). Our per response time estimates remain unchanged. Lastly, our cost estimates have increased by $1,931,374 as a result of the increased number of manufacturers and the use of more recent BLS wage data.

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Annual Cost to Federal Government: $0

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: 03/31/2020

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