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

Forms and Documents

Document Name	Status
Form CMS-10221 Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs) Form	New
CMS-10221.Supporting Statement.doc Supporting Statement A	2007-06-24

IC Document Collections

IC ID	Document Title	Status
181196	Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs) Form	New

ICR Details

OMB Control No: 0938-1029	ICR Reference No: 200707-0938-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs)
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: Approved without change	Conclusion Date: 11/30/2007
	Date Received in OIRA: 07/13/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2010	36 Months From Approved
Responses	2,000	0	0
Time Burden (Hours)	4,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Prior to enrolling in Medicare, independent diagnostic testing facilities IDTFs must undergo a site visit per 42 CFR 410.33. Section 410.33 was recently revised to add a significant number of standards that IDTFs must meet in order to enroll in Medicare. This was to further ensure that only qualified and legitimate IDTFs can bill Medicare and was especially important in light of concerns about recent fraudulent activity by some IDTFs. To this end, CMS submits the Worksheet for Recording Results of Medicare Site Visits of Independent Diagnostic Testing Facilities (IDTFs). The purpose of this document is to ensure that the individuals performing IDTF site visits take into account both new and existing IDTF standards in a consistent fashion. This PRA submission is necessary because some of the answers to the questions/data elements on the worksheet will have to be furnished by the IDTF.

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Authorizing Statute(s): 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 1395f Name of Law: Requirement of Requests and Certifications
   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:
	72 FR 18658	04/13/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 34468	06/22/2007
Did the Agency receive public comments on this ICR? No

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

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

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ICR Summary 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	2,000	0	0	2,000	0	0
Annual Time Burden (Hours)	4,000	0	0	4,000	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request. Per 42 CFR 410.33, any IDTF that wishes to enroll in the Medicare program must undergo a site visit. The purpose of the site visit is to ensure that the IDTF is in compliance with the provisions of 42 CFR 410.33, as well as all other applicable Federal, State and local laws and regulations. It is also used to verify the information the IDTF furnished on its CMS-855B enrollment application.

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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]? Uncollected

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)? Uncollected

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: 07/13/2007

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