Attending Physician's Certification of Medical Necessity for Home Oxygen Therapy and Supporting Regulations 42 CFR 410.38 and 42 CFR 424.5

Forms and Documents

Document Name	Status
Form CMS-484 Attending Physician's Certification of Medical Necessity for Home Oxygen Therapy and Supporting Regulations 42 CFR 410.38 and 42 CFR 424.5 Form and Instruction	Modified
CMS-484 - Supporting Statement Part 11717.docx Supporting Statement A	2017-01-17

IC Document Collections

IC ID	Document Title	Status
8145	Attending Physician's Certification of Medical Necessity for Home Oxygen Therapy and Supporting Regulations 42 CFR 410.38 and 42 CFR 424.5 Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0534	ICR Reference No: 201605-0938-011
Status: Historical Active	Previous ICR Reference No: 201501-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: 19157
Title: Attending Physician's Certification of Medical Necessity for Home Oxygen Therapy and Supporting Regulations 42 CFR 410.38 and 42 CFR 424.5
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/23/2017
	Date Received in OIRA: 05/11/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2018	36 Months From Approved	01/31/2017
Responses	1,632,000	0	1,632,000
Time Burden (Hours)	326,400	0	326,500
Cost Burden (Dollars)	0	0	0

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Abstract: This form is used to determine of oxygen is reasonable and necessary pursuant to Medicare Statute, Medicare claims for home oxygen therapy must be supported by the treating physician's statement and other information including estimate length of need (#of months), diagnosis codes (ICD-9) etc.

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Authorizing Statute(s): US Code: 42 USC 1395y(a) Name of Law: Items or Services Specifically Excluded
   US Code: 42 USC 1395x(n) Name of Law: Durable Medical Equipment
   US Code: 42 USC 1395j(5) Name of Law: Special Payment Rules for Particular Items and Services
   US Code: 42 USC 1395l(e) Name of Law: Information for Determination of Amounts Due
   US Code: 42 USC 1395m(j)(2) Name of Law: Certificates of Medical Necessity
   US Code: 42 USC 1395m(j)(2)(A)(iii) Name of Law: Special payment rules for particular items and services
  

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:
	81 FR 8498	02/19/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 29269	05/11/2016
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
Attending Physician's Certification of Medical Necessity for Home Oxygen Therapy and Supporting Regulations 42 CFR 410.38 and 42 CFR 424.5	CMS-484	Oxygen CMN

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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	1,632,000	1,632,000	0	0	0	0
Annual Time Burden (Hours)	326,400	326,500	0	0	-100	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: There is a 100 hour reduction due to a calculation error in the previous ICR submission.

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Annual Cost to Federal Government: $408,000

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]? 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? 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: 05/11/2016

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