Evaluation of Medicare National Competitive Bidding Program for DME

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10197 Non-Statistical Data - Private Sector (Informant Discussions)	Form and Instruction	Modified	Available
Form CMS-10197 Non-Statistical Data - Private Sector (Focus Groups)	Form and Instruction	Modified	Available
Form CMS-10197 Statistical Data - Households	Form and Instruction	Modified	Available
Form CMS-10197 Non-Statistical Data - Federal Government	Form and Instruction	New	Available
CMS-10197 PRA supporting statement 3-24-10 REDO_am.doc	Supporting Statement B	Uploaded 2010-04-13	Available
CMS-10197 Responsetocomments32610doc.pdf	Supplementary Document	Uploaded 2010-04-13	Available
CMS-10197 PRA supporting statement 3-24-10 REDO_am.doc	Supporting Statement A	Uploaded 2010-04-13	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
46620	Non-Statistical Data - Private Sector (Informant Discussions)	Form and Instruction	Modified
46619	Non-Statistical Data - Private Sector (Focus Groups)	Form and Instruction	Modified
46618	Statistical Data - Households	Form and Instruction	Modified
192613	Non-Statistical Data - Federal Government	Form and Instruction	New

ICR Details

OMB Control No: 0938-1015	ICR Reference No: 201004-0938-004
Status: Historical Active	Previous ICR Reference No: 200701-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Evaluation of Medicare National Competitive Bidding Program for DME
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/20/2010
	Date Received in OIRA: 04/19/2010
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2013	36 Months From Approved	05/31/2010
Responses	8,470	0	12,671
Time Burden (Hours)	4,342	0	6,557
Cost Burden (Dollars)	0	0	0

---

Abstract: Data collection materials consisting of beneficiary surveys and interview/discussion group guides are necessary to conduct the congressionally mandated evaluation of the Medicare National Competitive Bidding Program (see Medicare Modernization Act of 2003, Section 302b., and Medicare Improvements for Patients and Providers Act of 2008, Section 154). Information about the outcomes of competitive bidding, including expenditures, access, quality, beneficiary consumer satisfaction, and reductions in cost-sharing will be generated from these materials and reported to the Congress.

---

Authorizing Statute(s): PL: Pub.L. 108 - 173 303 Name of Law: MMA
   PL: Pub.L. 110 - 275 154 Name of Law: Medicare Improvements for Patients and Providers Act
  

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:
	74 FR 67227	12/18/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 16813	04/02/2010
Did the Agency receive public comments on this ICR? Yes

---

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

table that charts list of burden

IC Title	Form No.	Form Name
Statistical Data - Households	CMS-10197, CMS-10197	CMS-10197 AppendixD-InfConsentFormsScripts ,   CMS-10197 Appendix B Statistical Instruments
Non-Statistical Data - Private Sector (Focus Groups)	CMS-10197, CMS-10197	CMS-10197 AppendixC-NonstatisticalInstruments ,   CMS-10197 AppendixD-InfConsentFormsScripts
Non-Statistical Data - Federal Government	CMS-10197, CMS-10197	CMS-10197 AppendixC-NonstatisticalInstruments11_6_508ready ,   CMS-10197 AppendixD-InfConsentFormsScripts11
Non-Statistical Data - Private Sector (Informant Discussions)	CMS-10197, CMS-10197	CMS-10197 AppendixC-NonstatisticalInstruments11 ,   CMS-10197 AppendixD-InfConsentFormsScript

---

ICR Summary of Burden

table that charts list 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	8,470	12,671	0	-4,201	0	0
Annual Time Burden (Hours)	4,342	6,557	0	-2,215	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The initial OMB submission for this study included a survey of suppliers, which was conducted once (unsuccessfully) and will not be repeated. The burden for suppliers is thus diminished. The initial OMB submission for this study included two waves of beneficiary surveys, one of which was conducted in 2007 in three CAAs and two comparison areas but must be repeated in 2010 due to substantial program delays. To provide for improved sample sizes, we will add two more survey areas (one CAA and one comparison area) for the remainder of the survey waves. Thus burden is increased for beneficiaries by the addition of two more survey areas and decreased due to lower response rate; combined, these cause a net decrease in burden. The initial OMB submission for this study included three waves of qualitative data collection, two involving focus groups and all three involving key informant interviews. The first wave of qualitative data collection was conducted in 2007 but must be repeated in 2010 due to substantial program delays. In addition, we will conduct interviews with patient advocates and CMS officials during the transition in early 2011. Burden is increased by adding two more sites for nonstatistical data and additional interviews during the transition.

---

Annual Cost to Federal Government: $490,883

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 04/19/2010

---