Durable Medical Equipment Face-to-Face Requirements

Forms and Documents

Document Name	Status
f2f pra related commetns v2.docx Supplementary Document	2013-02-19
CMS-10447_-_Supporting_Statement_part_A_rev_11-20-2012 ab -- CLEAN.doc Supporting Statement A	2013-02-19

IC Document Collections

IC ID	Document Title	Status
203945	Durable Medical Equipment Scope and Conditions: Physician Assistant, Nurse Practitioner, and Nurse Specialist (sec. 410.38(g))	Modified
203944	Durable Medical Equipment Scope and Conditions: Physician (sec. 410.38(g))	Modified

ICR Details

OMB Control No: 0938-1181	ICR Reference No: 201211-0938-009
Status: Historical Active	Previous ICR Reference No: 201209-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Durable Medical Equipment Face-to-Face Requirements
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: 03/20/2013
	Date Received in OIRA: 11/28/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	36 Months From Approved
Responses	1,160,000	0	0
Time Burden (Hours)	125,667	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: To implement section 1834(a) of the Affordable Care Act, CMS published a notice of proposed rulemaking on July 30, 2012 and a final rule on November 16, 2012 (RIN 0938-AR11; CMS-1590-FC). The final rule revises ?410.38(g) by requiring, as a condition of payment for certain covered items of DME, that a physician must document and communicates to the DME supplier that the physician or physician assistant (PA), nurse practitioner (NP), or clinical nurse specialist (CNS) has had a face-to-face encounter with the beneficiary in the 6 months prior to the written order.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 6407(b) Name of Law: Affordable Care Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 6407(b) Name of Law: Affordable Care Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AR11	Final or interim final rulemaking	77 FR 68892	11/16/2012

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 44722	07/30/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 68892	11/16/2012
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Durable Medical Equipment Scope and Conditions: Physician (sec. 410.38(g))
Durable Medical Equipment Scope and Conditions: Physician Assistant, Nurse Practitioner, and Nurse Specialist (sec. 410.38(g))

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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	1,160,000	0	1,160,000	0	0	0
Annual Time Burden (Hours)	125,667	0	125,667	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: n/a. This is a new collection.

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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]? 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? 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: 11/28/2012

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