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OMB Control No: 0938-0676	ICR Reference No: 202403-0938-004
Status: Active	Previous ICR Reference No: 202102-0938-015
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 with change	Conclusion Date: 07/23/2024
	Date Received in OIRA: 03/07/2024
Terms of Clearance: Approved consistent with the understanding that CMCS must consider more recent outside consultation feedback on this collection, since the last time this implementation workgroup convened was in 1995.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved	07/31/2024
Responses	5,548	0	5,841
Time Burden (Hours)	251,272	0	248,584
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:
	88 FR 86905	12/15/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 15874	03/05/2024
Did the Agency receive public comments on this ICR? No

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

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	5,548	5,841	-749	456
Annual Time Burden (Hours)	251,272	248,584	-17,976	20,664
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: In this 2023/2024 iteration we have adjusted the number of CMS-304 respondents (manufacturer participation increased from 524 to 571) which resulted in an increase in our total time and total cost estimates. Our per response time estimate is unchanged. We have also adjusted the number of CMS-304a respondents (manufacturer participation increased from 749 to 816) which resulted in an increase in our total time and total cost estimates. Our per response time estimate is unchanged. Since the one-time system update requirement has been met, we are removing such requirements and burden for manufacturers to make any system updates to accommodate the updated field sizes and .CSV file formats for CMS-304 and 304a. We have also adjusted our cost estimates by using the most up to date BLS mean wage data. We are not proposing to change any of our currently approved reporting instruments or instructions. Overall, this iteration increases our active number of respondents (+114), decreases the number of responses (293), increases our time estimate (+2,688 hr), and increases our cost estimate (+ $781,835)

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

View ICR - OIRA Conclusion