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OMB Control No: 0938-1133	ICR Reference No: 201406-0938-005
Status: Historical Active	Previous ICR Reference No: 201102-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Disclosure Requirement for the In-Office Ancillary Services Exception (CMS-10332)
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: 09/30/2014
	Date Received in OIRA: 06/23/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved	09/30/2014
Responses	761,676	0	7,616,760
Time Burden (Hours)	19,638	0	196,383
Cost Burden (Dollars)	0	0	0

Abstract: n order to implement section 6003 of the Affordable Care Act, CMS has proposed to amend 42 C.F.R. 411.355(b). Section 6003 establishes a new disclosure requirement for physicians who refer magnetic resonance imaging, computed tomography, and positron emission tomography (MRI, CT and PET) under the in-office ancillary services exception to the prohibition on physician self-referral (section 1877 of the Social Security Act). Under this new requirement physicians must inform patients in writing, at the time of the referral, that the patient may receive the imaging service from another supplier. The physician must also provide the patient with a list of other suppliers that from whom the patient may obtain the services. The proposed rule provides detail regarding what criteria must be included in the disclosure notifcation and supplier list in order to satisfy this new requirement.

Authorizing Statute(s): PL: Pub.L. 111 - 148 6003 Name of Law: Disclosure requirements for in-office ancillary services exception

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 6003 Name of Law: Disclosure requirements for in-office ancillary services exception

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:
	79 FR 18916	04/04/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 33928	06/13/2014
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
Development of Form
Disclosure Requirement

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	761,676	7,616,760	-6,855,084
Annual Time Burden (Hours)	19,638	196,383	-176,745
Annual Cost Burden (Dollars)	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: We have adjusted the disclosure burden for 71,000 physicians since this was a one-time requirement that has been met. We have adjusted the burden to reflect that the requirement now applies to the 7,100 newly enrolled physicians in the Medicare program. We also adjusted the payment estimates for a healthcare worker in a physician office from $14,68 to $17.23. The revised annual cost burden of creating the disclosure and list of alternative suppliers is now $122,333, a decrease from the previous burden of $1,042,280. The new annual burden for creating the disclosure forms for each newly enrolled physician is now 7,100 hours, a decrease from the previous burden hours of 71,000 hours. The average hourly rate for general practice physicians in a physician office, increased to $91.25 from $83.79. The revised annual cost burden is estimated to be is $1,053,640, a decrease from the previous estimate of $10,536,400. The estimated annual hour burden for this disclosure requirement is 12,538 hours, a decrease from the previous 125,383 hours.

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

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

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