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 (2021 version 1).docx Supporting Statement A	2021-02-25
Comment Responses for PRA-0938-0676_Final.pdf Supplementary Document	2021-02-19

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
245951	CMS-304 and CMS-304a – One-Time System Updates	New

ICR Details

OMB Control No: 0938-0676	ICR Reference No: 202102-0938-015
Status: Received in OIRA	Previous ICR Reference No: 202003-0938-011
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	Date Submitted to OIRA: 02/26/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2023
Responses	5,841	5,020
Time Burden (Hours)	248,584	227,416
Cost Burden (Dollars)	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:
	85 FR 76577	11/30/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 10971	02/23/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
CMS-304 and CMS-304a – One-Time System Updates
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 Request	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	5,841	5,020	0	749	72	0
Annual Time Burden (Hours)	248,584	227,416	0	17,976	3,192	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: No

Burden Reduction Due to:

Short Statement: Effective July 1, 2021, the Medicaid Drug Rebate Program (MDRP) is updating to a new Medicaid Drug Programs (MDP) system which will now accept a delimited text file format, Comma Separated Values (.CSV), in addition to the current Text (.TXT) file format. We have also increased several file format data field sizes in order to accommodate the higher priced drugs that are entering the market. These changes in conjunction with numerous edits to verbiage are applicable to Forms CMS-304 and CMS-304a. This PRA package (0938-0676) is simultaneously being updated along with our two corresponding PRA packages (0938-0578 and 0938-0582), so that all the MDP file formats, field sizes, and verbiage will align across the MDRP. We have also adjusted the number of CMS-304 respondents (manufacturer participation increased from 517 to 534) which resulted in an increase in our total time and total cost estimates. Our per response time estimate in unchanged. We have also adjusted the number of CMS-304a respondents (manufacturer participation increased from 738 to 749) which resulted in an increase in our total time and total cost estimates. Our per response time estimate in unchanged. See section 15 for more details regarding the changes.

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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: 02/26/2021

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