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OMB Control No: 0938-0749	ICR Reference No: 201910-0938-009
Status: Historical Active	Previous ICR Reference No: 201509-0938-002
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 (CMS-R-263)
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 without change	Conclusion Date: 01/12/2021
	Date Received in OIRA: 11/14/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2024	36 Months From Approved
Responses	8,255	0	0
Time Burden (Hours)	8,255	0	0
Cost Burden (Dollars)	0	0	0

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.

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
   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
   US Code: 42 USC 1395f Name of Law: Conditions of and limitations on payment for services

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 9526	03/15/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 47518	09/10/2019
Did the Agency receive public comments on this ICR? No

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

ICR Summary of Burden

	Total Approved	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	8,255	-21,745	30,000
Annual Time Burden (Hours)	8,255	-6,745	15,000
Annual Cost Burden (Dollars)	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 prior renewal of CMS-R-263 estimated 30 minutes to complete a site visit, which totaled 15,000 hours annually. Updated information shows a site visit takes one hour. The difference in time it takes to complete a site visit is 30 minutes (one hour minus 30 minutes). The prior renewal of the CMS-R-263 estimated approximately 30,000 DMEPOS suppliers were visited per year. Updated information shows 8,255 suppliers received site visits for calendar year 2017. The difference in respondents is 21,745 (30,000 minus 8,255). Presently, using better information collection techniques (exact figures from the NSC MAC’s enrollment systems) which are taken directly from the actual site visits processed for calendar year 2017, CMS knows the NSC MAC currently processed 8,255 site visits annually (in calendar year 2017), equaling the decreased figure of 8,255 respondents. The prior renewal of the CMS-R-263 estimated $225.00 per site visit, which totaled $6,750,000.00 annually. Updated information shows a site investigation costs of $200.00 per site visit, equaling $1,651,000.00 annually. The difference is a decrease in cost burden of $5,099,000 ($6,750,000.00 minus $1,651,000.00). In conclusion, there is an overall decrease of burden hours, from 15,000 hours to 8,255 hours. The decrease of 6,745 burden hours is the difference from the previously estimated 15,000 burden hours in 2015 to the accurately reported 8,255 total annual hours for processing in calendar year 2017. Although there was an increase in the time it takes to conduct a site visit (from 30 minutes to one hour), this did not increase the burden hours due to the accurate number of processed site visits being less than previously reported.

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. 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

Agency Contact: Jamaa Hill 301 492-4190

View ICR - OIRA Conclusion