Reconciliation of State Invoice (ROSI) and Prior Quarter Adjustment Statement (PQRS) (CMS-304 and 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 [rev 04-27-2017 by OSORA PRA].docx Supporting Statement A	2017-04-28

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: 201704-0938-010
Status: Historical Active	Previous ICR Reference No: 201407-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: Reconciliation of State Invoice (ROSI) and Prior Quarter Adjustment Statement (PQRS) (CMS-304 and CMS-304a)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/19/2017
	Date Received in OIRA: 04/28/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2020	36 Months From Approved	09/30/2017
Responses	4,468	0	4,148
Time Burden (Hours)	202,384	0	187,880
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 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

---

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:
	82 FR 11040	02/17/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 19733	04/28/2017
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
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)

---

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	4,468	4,148	0	0	320	0
Annual Time Burden (Hours)	202,384	187,880	0	0	14,504	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: This package does not propose any program changes. All forms are unchanged. The total number of annual burden hours increased for both forms due to an increase in the number of respondents (manufacturer participation increased from 610 to 657). The time per response is unchanged. Overall, the burden has increased by 14,504 hours (from 187,880 hr to 202,384 hr). Cost estimates also increased due to the increase in manufacturer participation, and because the previous PRA package inconsistently reflected cost estimates, and did not designate specific BLS occupational titles and hours to the burden estimates. This iteration proposes to correct those omissions by setting out the time and cost estimates for each of the occupational titles.

---

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

---

Common Form ICR:  No

---

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: 04/28/2017

---