On-Site Inspection for Durable Medical Equipment (DME) Supplier Location and Supporting Regulations in 42 CFR, Section 424.57

Forms and Documents

Document Name	Status
Form CMS-R-263 On-Site Inspection for Durable Medical Equipment (DME) Supplier Location and Supporting Regulations in 42 CFR, Section 424.57 Form and Instruction	Modified
CMS-R-263.Site Visit Form Revisions - Crosswalk from old to new.doc Supplementary Document	2008-08-14
CMS-R-263.Supporting Statement.doc Supporting Statement A	2008-08-14

IC Document Collections

IC ID	Document Title	Status
8454	On-Site Inspection for Durable Medical Equipment (DME) Supplier Location and Supporting Regulations in 42 CFR, Section 424.57 Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0749	ICR Reference No: 200809-0938-002
Status: Historical Active	Previous ICR Reference No: 200409-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: On-Site Inspection for Durable Medical Equipment (DME) Supplier Location and Supporting Regulations in 42 CFR, Section 424.57
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/05/2008
	Date Received in OIRA: 09/04/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	36 Months From Approved
Responses	30,000	0	0
Time Burden (Hours)	15,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CMS is mandated to identify and implement measures to prevent fraud and abuse in the Medicare program. To meet this challenge, CMS has moved forward to improve the quality of the process for enrolling suppliers into the Medicare program by establishing a uniform application for enumerating suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Implementation of enhanced procedures for verifying the enrollment information has also improved the enrollment process. As part of this process, verification of compliance with supplier standards is necessary. The site investigation form has been used in the past to aid the Medicare contractor (the National Supplier Clearinghouse and/or its subcontractors) in verifying compliance with the required supplier standards found in 42 CFR 424.57(c). The primary function of the site investigation form is to provide a standardized, uniform tool to gather information from a DMEPOS supplier that tells us whether it meets certain qualifications to be a DMEPOS supplier (as found in 42 CFR 424.57(c)) and where it practices or renders its services. We are requesting minimal changes to the wording of some of the questions. These changes do not change the information collection as it currently exists. The changes we are requesting are needed to clarify the information collected by our contractors and to simplify the wording for the DMEPOS suppliers.

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Authorizing Statute(s): EO: EO 12600 Name/Subject of EO: Predisclosure notification procedures for confidential commercial information
   US Code: 42 USC 1395l Name of Law: Payment of Benefits
   US Code: 42 USC 1395f Name of Law: Conditions of and limitations on payment for services
   PL: Pub.L. 99 - 272 9202(g) Name of Law: Budget Reconciliation Act of 1985
   US Code: 5 USC 522(b)(4) Name of Law: The Freedom of Information Act
  

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:
	73 FR 19854	04/11/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 42578	07/22/2008
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
On-Site Inspection for Durable Medical Equipment (DME) Supplier Location and Supporting Regulations in 42 CFR, Section 424.57	CMS-R-263	CMS-R-263 DMEPOS Site Visit Form

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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	30,000	0	0	10,000	0	20,000
Annual Time Burden (Hours)	15,000	0	0	5,000	0	10,000
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: As of this ICR submission, the burden will increase from 10,000 hours to 15,000 hours annually. This is due to the increased number of site visits performed by the National Supplier Clearinghouse.

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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: 09/04/2008

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