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

Forms and Documents

Document Name	Status
Form CMS-854 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	New
CMS-0679 CMN Supporting Statement - FINAL.docx Supporting Statement A	2017-02-09

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	New

ICR Details

OMB Control No: 0938-0679	ICR Reference No: 201605-0938-012
Status: Historical Active	Previous ICR Reference No: 201410-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No: 19199
Title: Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation
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: 02/17/2017
	Date Received in OIRA: 05/12/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved	02/28/2017
Responses	2,094,000	0	462,000
Time Burden (Hours)	418,800	0	92,400
Cost Burden (Dollars)	0	0	0

---

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.

---

Authorizing Statute(s): US Code: 42 USC 1395j(5) Name of Law: Special Payment Rules for Particular Items and Services
   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: Penalty
   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
  

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:
	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

---

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	CMS-854 -- CONTINUATION FORM ,   CMS for PNEUMATIC COMPRESSION DEVICES ,   CMN for TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) ,   CMN for OSTEOGENESIS STIMULATORS ,   CMN for EXTERNAL INFUSION PUMPS ,   CMN for ENTERAL AND PARENTERAL NUTRITION ,   CMN for SEAT LIFT MECHANISMS

---

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	2,094,000	462,000	0	0	1,632,000	0
Annual Time Burden (Hours)	418,800	92,400	0	0	326,400	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: CMS is increasing the burden from 92,163 hours to 418,800 hours to account for merging CMS-484, into this collection; therefore there is a total burden hour increase of 326,400.

---

Annual Cost to Federal Government: $523,204

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

---

Common Form ICR:  No

---

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: 05/12/2016

---