Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs) (CMS-10221)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10221 Site Investigation for Independent Diagnostic Testing Facilities Application	Form and Instruction	Modified	Available
Form CMS-10221 Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs)	Form and Instruction	Modified	Repair queued
CMS-10221 - Supporting Statement --.docx	Supporting Statement A	Uploaded 2023-06-06	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
181196	Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs)	Form and Instruction	Modified	Site Investigation for Independent Diagnostic Testing Facilities Application
181196	Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs)	Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1029	ICR Reference No: 202306-0938-004
Status: Active	Previous ICR Reference No: 202001-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CMS-10221
Title: Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs) (CMS-10221)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/30/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/07/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2027	36 Months From Approved
Responses	652	0	0
Time Burden (Hours)	1,304	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Independent Diagnostic Testing Facilities (IDTF) - Site Investigation form was developed and implemented to allow for CMS to have a standard format to collect and verify information regarding the compliance of independent diagnostic testing facilities (IDTFs) with the performance standards found in 42 CFR 410.33(g). CMS is now seeking re-instatement of the use of this form.

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Authorizing Statute(s): US Code: 42 USC 1395f Name of Law: Requirement of Requests and Certifications
   PL: Pub.L. 105 - 33 4313 Name of Law: BBA of 1997
   PL: Pub.L. 104 - 134 31001 Name of Law: The Debt Collection Improvement Act of 1996
   US Code: 42 USC 1395g Name of Law: PAYMENT TO PROVIDERS OF SERVICES
   US Code: 42 USC 1395l Name of Law: Payment of Benefits
   US Code: 42 USC 1395u Name of Law: PROVISIONS RELATING TO THE ADMINISTRATION OF PART B
   US Code: 42 USC 1395m Name of Law: SPECIAL PAYMENT RULES FOR PARTICULAR ITEMS AND SERVICES
   US Code: 42 USC 1395cc Name of Law: AGREEMENTS WITH PROVIDERS OF SERVICES; ENROLLMENT PROCESSES
  

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:
	88 FR 18141	03/27/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 35878	06/01/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs)	CMS-10221	Site Investigation for Independent Diagnostic Testing Facilities Application

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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	652	0	0	0	-75	727
Annual Time Burden (Hours)	1,304	0	0	0	-150	1,454
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: The currently approved burden estimate was based on 727 respondents annually with an annual total burden hours of 1,454. This was calculated at an hour amount per application (two hours per application). Based on these numbers, there is an annual decrease in respondents of 75(from 727 to 652). CMS believes this decrease is due to less IDTFs entering the Medicare program. Over a three-year period, the hour burden has decreased by 450 hours (from 4,362 to 3,912 hours).

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Annual Cost to Federal Government: $130,400

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.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

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: 06/07/2023

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