Disclosure Requirement for the In-Office Ancillary Services Exception (CMS-10332)

Forms and Documents

Document Name	Status
CMS_10332___Supporting_Statement_A 508.docx Supporting Statement A	2024-07-25

IC Document Collections

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

ICR Details

OMB Control No: 0938-1133	ICR Reference No: 202407-0938-013
Status: Received in OIRA	Previous ICR Reference No: 202101-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
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	Date Submitted to OIRA: 08/27/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2024
Responses	974,557	989,971
Time Burden (Hours)	18,107	18,701
Cost Burden (Dollars)	0	0

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Abstract: In 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: Disclosure requirements for in-office ancillary services exception
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 19315	03/18/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 50591	06/14/2024
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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ICR Summary of Burden

	Total Request	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	974,557	989,971	0	-15,414	0	0
Annual Time Burden (Hours)	18,107	18,701	0	-594	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: We updated the burden estimates to reflect changes in the number of physicians, the number of disclosures, and the hourly wages of the personnel preparing and delivering the disclosure. The total time burden has decreased by 594 hours.

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Annual Cost to Federal Government: $1,505

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

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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: 08/27/2024

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