Medicare Self-Referral Disclosure Protocol (CMS-10328)

Forms and Documents

Document Name	Status
Form CMS-10328 Financial Review Form and Instruction	Modified
Form CMS-10328 Legal Review Form and Instruction	Modified
CMS_10328_Supporting_Statement_Part_A_5_22_2025.docx Supporting Statement A	2025-09-26

IC Document Collections

IC ID	Document Title	Status
194183	Financial Review Form and Instruction	Modified
194182	Legal Review Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1106	ICR Reference No: 202509-0938-026
Status: Received in OIRA	Previous ICR Reference No: 202208-0938-025
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
Title: Medicare Self-Referral Disclosure Protocol (CMS-10328)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/04/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	200	200
Time Burden (Hours)	4,950	5,000
Cost Burden (Dollars)	0	0

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Abstract: The 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 (the "Secretary"), in cooperation with the Office of Inspector General of the Department of Health and Human Services (the "Inspector General"), 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 (the Act). In accordance with the ACA, the SRDP was established on September 23, 2010, six months after the date of enactment, and information concerning how to disclose an actual or potential violation of section 1877 of the Act was posted on the CMS website.

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

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:
	90 FR 27540	06/27/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 45941	09/24/2025
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
Financial Review	CMS-10328, CMS-10328, CMS-10328	Group Practice Information ,   Physician Information ,   Voluntary Self Referral Disclosure
Legal Review	CMS-10328, CMS-10328, CMS-10328	Voluntary Self Referral Disclosure Protocol ,   Group Practice Information ,   Physician Information

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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	200	200	0	0	0	0
Annual Time Burden (Hours)	4,950	5,000	0	-50	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: Cutting Redundancy

Short Statement: For a disclosing party that is disclosing noncompliance arising from the failure of a physician or physicians in a practice that qualifies as a group practice under § 411.352 to satisfy the disclosure requirement for certain imaging services required at § 411.355(b)(7) to submit only one Physician Information Form instead of separate Physician Information Forms for each physician in the practice who made prohibited referrals. This causes a decrease in burden.

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Annual Cost to Federal Government: $883,820

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: 11/04/2025

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