Disclosure Requirement for the In-Office Ancillary Services Exception

Forms and Documents

Document Name	Status
CMS-10332.Supporting Statement Part A.docx Supporting Statement A	2010-08-11

IC Document Collections

IC ID	Document Title	Status
194232	Disclosure Requirement	New
194231	Development of Form	New

ICR Details

OMB Control No: 0938-1133	ICR Reference No: 201008-0938-006
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Disclosure Requirement for the In-Office Ancillary Services Exception
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 09/01/2010
	Date Received in OIRA: 08/11/2010
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, the agency should resubmit this ICR at the final rule stage.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 6003 Name of Law: The Patient Protection and Affordable Care Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 6003 Name of Law: The Patient Protection and Affordable Care Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AP79	Proposed rulemaking	75 FR 40040	07/13/2010

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Development of Form
Disclosure Requirement

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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.

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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]? 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

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Common Form ICR:  No

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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: 08/11/2010

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