Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation

Forms and Documents

Document Name	Status
Form CMS-10126 Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation Form and Instruction	Modified
Form CMS-484 Oxygen and Supplies Form and Instruction	Modified
CMS-484-10126 - Supporting Statement Part A.docx Supporting Statement A	2020-02-27
CMS-484-10126 - Appendix A - Response to Public Comments.pdf Supplementary Document	2020-02-26

IC Document Collections

IC ID	Document Title	Status
37897	Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation Form and Instruction	Modified
221459	Oxygen and Supplies Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0679	ICR Reference No: 202002-0938-014
Status: Active	Previous ICR Reference No: 201605-0938-012
Agency/Subagency: HHS/CMS	Agency Tracking No: CPI
Title: Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/04/2020
	Date Received in OIRA: 02/27/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved	06/30/2020
Responses	1,335,658	0	2,094,000
Time Burden (Hours)	267,131	0	418,800
Cost Burden (Dollars)	0	0	0

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Abstract: This information is needed to correctly process claims and ensure that claims are properly paid. These forms contain medical information necessary to make an appropriate claim determination. Suppliers and physicians will complete these forms and as needed supply additional routine supporting documentation to process claims.

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Authorizing Statute(s): US Code: 42 USC 1395m(j)(2)(A)(iii) Name of Law: Penalty
   US Code: 42 USC 1395j(5) Name of Law: Special Payment Rules for Particular Items and Services
   US Code: 42 USC 1395y(a)(1)(A) Name of Law: Items or Services Specifically Excluded
   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 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
  

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:
	84 FR 57734	10/28/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 10442	02/24/2020
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
Oxygen and Supplies	CMS-484	Certificate of Medical Necessity - Oxygen
Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation	CMS-846, CMS-847, CMS-848, CMS-849, CMS-10125, CMS-10126, CMS-854	CMN for ENTERAL AND PARENTERAL NUTRITION ,   CMS-854 -- CONTINUATION FORM ,   CMS for PNEUMATIC COMPRESSION DEVICES ,   CMN for OSTEOGENESIS STIMULATORS ,   CMN for TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) ,   CMN for SEAT LIFT MECHANISMS ,   CMN for EXTERNAL INFUSION PUMPS

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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	1,335,658	2,094,000	0	0	-758,342	0
Annual Time Burden (Hours)	267,131	418,800	0	0	-151,669	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: As a result in decreasing the annual number of CMN submissions, CMS is decreasing the burden from 418,800 hours to 267,131 hours. Therefore, there is a total burden hour decrease of 151,669.

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Annual Cost to Federal Government: $333,915

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.     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? No

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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: 02/27/2020

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