Medicare Self-Referral Disclosure Protocol (CMS-10328)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10328 Group Practice	Form and Instruction	Modified	Available
Form CMS-10328 Self Referral Disclosure	Form and Instruction	Modified	Available
Form CMS-10328 CMS-10328_Physician_Information_Form	Form and Instruction	Modified	Available
Form CMS-10328 Financial Review	Form and Instruction	Modified	Repair queued
Form CMS-10328 Group Practice Information	Form and Instruction	Modified	Available
Form CMS-10328 Physician-Information	Form and Instruction	Modified	Available
Form CMS-10328 Self-Referral_Disclosure_Protocol_Form	Form and Instruction	Modified	Available
Form CMS-10328 Legal Review	Form and Instruction	Modified	Repair queued
Response to Public Comments - CMS-10328 clean.docx	Supplementary Document	Uploaded 2022-09-12	Available
CMS_10328_Supporting_Statement_Part_A.docx	Supporting Statement A	Uploaded 2022-09-12	Repair queued
CMS_10138___Crosswalk___30_dcay_PRA_package.pdf	Supplementary Document	Uploaded 2022-08-30	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
194183	Financial Review	Form and Instruction	Modified	Group Practice
194183	Financial Review	Form and Instruction	Modified	Self Referral Disclosure
194183	Financial Review	Form and Instruction	Modified	CMS-10328_Physician_Information_Form
194183	Financial Review	Form and Instruction	Modified
194182	Legal Review	Form and Instruction	Modified	Group Practice Information
194182	Legal Review	Form and Instruction	Modified	Physician-Information
194182	Legal Review	Form and Instruction	Modified	Self-Referral_Disclosure_Protocol_Form
194182	Legal Review	Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1106	ICR Reference No: 202208-0938-025
Status: Historical Active	Previous ICR Reference No: 201909-0938-006
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/28/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/16/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2025	36 Months From Approved	12/31/2022
Responses	200	0	200
Time Burden (Hours)	5,000	0	5,000
Cost Burden (Dollars)	0	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:
	87 FR 35218	06/09/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 54697	09/07/2022
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Financial Review	CMS-10328, CMS-10328, CMS-10328	CMS-10328_Physician_Information_Form ,   Self Referral Disclosure ,   Group Practice
Legal Review	CMS-10328, CMS-10328, CMS-10328	Self-Referral_Disclosure_Protocol_Form ,   Physician-Information ,   Group Practice Information

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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)	5,000	5,000	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

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: 09/16/2022

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