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OMB Control No: 0938-1106	ICR Reference No: 201008-0938-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Self-Referral Disclosure Protocol
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Emergency	Approval Requested By: 09/01/2010
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/16/2010
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/10/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2011	6 Months From Approved
Responses	100	0	0
Time Burden (Hours)	1,200	0	0
Cost Burden (Dollars)	0	0	0

Abstract: The Patient Protection and Affordable Care Act (ACA) was enacted on March 23, 2010. Section 6409 of the ACA requires the Secretary of the Department of Health and Human Services, in cooperation with the Inspector General of the Department of Health and Human Services, to establish a Medicare self-referral disclosure protocol ("SRDP") that sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute (Section 1877 of the Social Security Act, "Section 1877"). We believe that in order to effectively self-disclose an actual or potential violation, the SRDP must require health care providers of services or suppliers to submit all information necessary for CMS, on behalf of the Secretary, to analyze the actual or potential violation of Section 1877 of the Act. Therefore, in accordance with Section 6409(a)(1), this information collection request sets forth the specific information related to the actual or potential violation(s) and the related financial analysis that must be furnished by health care providers of services and suppliers as part of their voluntary disclosure submission to participate in the SRDP The collection may seek additional financial documentation and other information as the Secretary considers appropriate to establish the amount due and owing for the violation. Section 6409(b), gives the Secretary of HHS the authority to reduce the amount due and owing for all violations of Section 1877. In establishing such amount due and owing for the violation, the Secretary may consider: the nature and extent of the improper or illegal practice; the timeliness of the self-disclosure; the cooperation in providing additional information related to the disclosure; and such other factors as the Secretary considers appropriate.

Emergency Justfication: In accordance with Section 6409 of The Patient Protection and Affordability Care Act (ACA), the Secretary of HHS, in cooperation with the Inspector General of HHS, is tasked with establishing a self-referral disclosure protocol to enable health care providers of services and suppliers to disclose an actual or potential violation of section 1877 of the Social Security Act. The Self-Referral Disclosure Protocol must be established by September 23, 2010 and information must be published on CMS' website instructing relevant stakeholders how to disclose actual or potential violations pursuant to the Protocol. Due to the urgency and the short time frames associated with this requirement, CMS does not have sufficient time to follow the notice and comment periods associated with the usual OMB approval process. Therefore, we are requesting an emergency review and approval for this information collection request.

Authorizing Statute(s): PL: Pub.L. 111 - 148 6409 Name of Law: Medicare self-referral disclosure protocol.
US Code: 42 USC 1395nn Name of Law: Limitation on Certain Physician Referrals

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 6409 Name of Law: Medicare self-referral disclosure protocol.

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

Federal Register Notices & Comments
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
Financial Review
Legal Review

ICR Summary of Burden

	Total Approved	Change Due to New Statute
Annual Number of Responses	100	100
Annual Time Burden (Hours)	1,200	1,200
Annual Cost Burden (Dollars)	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 is a new information collection request.

Annual Cost to Federal Government: $341,477

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]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: William Parham 4107864669

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