Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project : Bidding Form

Forms and Documents

Document Name	Status
Form CMS-10193 Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project: Bidding Form Form	New
Public Comments #16 thru #186.pdf Supplementary Document	2006-08-30
Public Comments #197 and #198.pdf Supplementary Document	2006-08-30
Public Comments #193 thru #196.pdf Supplementary Document	2006-08-30
Public Comments #11 thru 15.pdf Supplementary Document	2006-08-30
Public Comments #6 thru #10.pdf Supplementary Document	2006-08-30
Public Comments #1 thru #5.pdf Supplementary Document	2006-08-30
Public Comment #199.pdf Supplementary Document	2006-08-30
Response to Public Comment ending June 20 2006.doc Supplementary Document	2006-08-30
CMS 10193 revised Supporting Statement 302b (v3).doc Supporting Statement A	2006-08-30

IC Document Collections

IC ID	Document Title	Status
45033	Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project : Bidding Form Instruction	New
45032	Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project: Bidding Form Form	New

ICR Details

OMB Control No: 0938-1008	ICR Reference No: 200608-0938-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project : Bidding Form
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/05/2007
	Date Received in OIRA: 08/30/2006
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2009	36 Months From Approved
Responses	80	0	0
Time Burden (Hours)	7,010	0	0
Cost Burden (Dollars)	4,113	0	0

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Abstract: The Medicare Clinical Laboratory Competitive Bidding Demonstration is mandated by section 302(b) of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003 (P.L. 108-173). The purpose of the demonstration is to determine whether competitive bidding can be used to provide quality laboratory services at prices below current Medicare reimbursement rates. The winning laboratories should be selected based on multiple criteria, including price bid, laboratory capacity, service area, and quality. Multiple winners are expected in each competitive acquisition area.

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Authorizing Statute(s): PL: Pub.L. 108 - 173 302 Name of Law: Payment for Durable Medical Equipment
  

Citations for New Statutory Requirements: PL: Pub.L. 108 - 173 302 Name of Law: Payment for Durable Medical Equipment

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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:
	71 FR 20697	04/21/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 42850	07/28/2006
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
Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project: Bidding Form	CMS-10193	The Medicare Clinical Laboratory Competitive Biddin
Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project : Bidding Form	CMS-10193	THE MEDICARE CLINICAL LABORATORY COMPETITIVE BIDDIN

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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	80	0	80	0	0	0
Annual Time Burden (Hours)	7,010	0	7,010	0	0	0
Annual Cost Burden (Dollars)	4,113	0	4,113	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:

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Annual Cost to Federal Government: $324

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]? 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)? Uncollected

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: 08/30/2006

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