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OMB Control No: 0938-0676	ICR Reference No: 202102-0938-015
Status: Historical Active	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
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/17/2021
	Date Received in OIRA: 02/26/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2024	36 Months From Approved	06/30/2023
Responses	5,841	0	5,020
Time Burden (Hours)	248,584	0	227,416
Cost Burden (Dollars)	0	0	0

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.

Authorizing Statute(s): Statute at Large: 21 Stat. 1927
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

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

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

IC Title	Form No.	Form Name
CMS-304 and CMS-304a – One-Time System Updates
Prior Quarter Adjustment Statement (PQAS) (CMS-304a)	CMS-304a
Reconciliation of State Invoice (ROSI) (CMS-304)	CMS-304

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	5,841	5,020	749	72
Annual Time Burden (Hours)	248,584	227,416	17,976	3,192
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov

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