Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program – Contracting Forms (CMS-10744)

Forms and Documents

Document Name	Status
Form CMS-10744.Change o Change of Ownership Form and Instruction	New
Form CMS-10744 Subcontracting Form and Instruction	New
Form CMS-10744. Form C Form C Form and Instruction	New
CMS-10744.Function Fields Updated.xlsx Supplementary Document	2020-11-05
CMS-10744.SupportingStatementPartA (final).docx Supporting Statement A	2020-11-05

IC Document Collections

IC ID	Document Title	Status
244401	Grandfathering Instruction	New
244400	Change of Ownership Form and Instruction	New
244399	Subcontracting Form and Instruction	New
244398	Form C Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202011-0938-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CM
Title: Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program – Contracting Forms (CMS-10744)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/05/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	271,597	0
Time Burden (Hours)	32,121	0
Cost Burden (Dollars)	0	0

---

Abstract: The Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program was established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“Medicare Modernization Act” or “MMA”). Section 302 of the MMA amended Section 1847 of the Social Security Act (the Act) to establish the competitive acquisition program and define program requirements. Under the MMA, the DMEPOS Competitive Bidding Program was to be phased in so that competition under the program would first occur in 10 areas in 2007. The Centers for Medicare & Medicaid Services (CMS) completed the rulemaking process for the competitive acquisition of DMEPOS items and services in 42 CFR Parts 411 and 414 published in the Federal Register Volume 72 on April 10, 2007. CMS conducted the Round 1 competition in 10 areas and for 10 DMEPOS product categories, and implemented the program on July 1, 2008. The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), enacted on July 15, 2008, made limited changes to the Competitive Bidding Program, including termination of existing contracts that were in effect and a requirement to re-bid Round 1. As required by MIPPA, CMS conducted the competition for the Round 1 Rebid in 2009. The Round 1 Rebid contracts and prices became effective on January 1, 2011. The Affordable Care Act (ACA), enacted on March 23, 2010, expanded the Round 2 competition by adding an additional 21 metropolitan statistical areas (MSAs), bringing the total MSAs for Round 2 to 91. The competition for Round 2 began in December 2011. CMS also began a competition for National Mail Order (NMO) of diabetes testing supplies at the same time as Round 2. The Round 2 and NMO contracts and prices were implemented on July 1, 2013. The MMA requires the Secretary to recompete contracts not less often than once every three years. The Round 1 Rebid contract period for all product categories except mail-order diabetes testing supplies expired on December 31, 2013. (Round 1 Rebid contracts for mail-order diabetes testing supplies ended on December 31, 2012.) The competition for the Round 1 Recompete began in August of 2012 and contracts and prices became effective on January 1, 2014. The Round 1 Recompete contract period expires on December 31, 2016. Round 1 2017 contracts will become effective on January 1, 2017 through December 31, 2018. Round 2 and NMO contracts and prices expired on June 30, 2016. Round 2 Recompete and the NMO Recompete contracts became effective on July 1, 2016, and expired on December 31, 2018. CMS will be implementing a consolidated round of competition to include all Round 1 2017 and Round 2 Recompete competitive bidding areas, referred to as Round 2021. Round 2021 will not include NMO, which will be competed again in future rounds of the program.

---

Authorizing Statute(s): PL: Pub.L. 110 - 275 154 Name of Law: Delay in and reform of Medicare DMEPOS competitive acquisition program.
   PL: Pub.L. 108 - 173 302 Name of Law: Payment for durable medical equipment; competitive acquisition of certain items and services.
   PL: Pub.L. 111 - 148 6410 Name of Law: Adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies competit
  

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:
	85 FR 39568	07/01/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 71066	11/04/2020
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Form C	CMS-10744. Form C	Form C: Semi Annual Report
Change of Ownership	CMS-10744.Change of Ownership Form (30-day notice)	CMS-10744.Change of Ownership Form (30-day notice)
Grandfathering
Subcontracting	CMS-10744	Subcontracting Disclosure

---

ICR Summary of Burden

	Total Request	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	271,597	0	0	271,597	0	0
Annual Time Burden (Hours)	32,121	0	0	32,121	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

---

Annual Cost to Federal Government: $106,322

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

---

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: 11/05/2020

---