Medicare Part B Drug and Biological Competitive Acquisition Program Applications

Forms and Documents

Document Name	Status
Form CMS-10133 Medicare Part B Drug and Biological Competitive Acquisition Program Applications Form and Instruction	Modified
cap.osora.cms10133.2009.submitted.crosswalk-EK.doc Supplementary Document	2009-06-09
cap.osora.cms10133.2009.submitted.supstate.doc Supporting Statement A	2009-06-09

IC Document Collections

IC ID	Document Title	Status
43673	Medicare Part B Drug and Biological Competitive Acquisition Program Applications Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0955	ICR Reference No: 200906-0938-012
Status: Historical Active	Previous ICR Reference No: 200712-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Part B Drug and Biological Competitive Acquisition Program Applications
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: 08/19/2009
	Date Received in OIRA: 06/24/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2012	36 Months From Approved	08/31/2009
Responses	10	0	12
Time Burden (Hours)	1	0	480
Cost Burden (Dollars)	0	0	0

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Abstract: Section 303 (d) of the Medicare Modernization Act (MMA) requires the implementation of a competitive acquisition program for Medicare Part B drugs and biologicals not paid on a cost or prospective payment system basis. The CAP is an alternative to the Average Sales Price (ASP or "buy and bill") method of acquiring many Part B drugs and biologicals administered incident to a physician's services. The CAP was implemented on July 1, 2006 with one approved CAP vendor supplying drugs for the program under a three year contract. In 2008, a competition for the 2009-2011 vendor contracts was held. However, CMS could not finalize a contract with any of the successful bidders. Therefore, the CAP was put on hold on January 1, 2009 as the 2006-2008 vendor contract expired. The re-implementation schedule has yet to be finalized and future plans for the program are dependent on direction from the new administration. This extension request covers the CAP Vendor Application and Bid Form, which has been used by bidders to provide a response to CMS' solicitation for approved CAP vendor bids and to submit their bid prices for CAP drugs. The current approval for this PRA expires on August 31, 2009. Though the program is currently on hold and a timeline for the resumption of the CAP has not been established, the CAP Vendor Application and Bid Form will be required to conduct the next round of vendor bidding. Having a vehicle to collect responses from bidders is necessary if the option for early rebidding is chosen by the new administration. CMS does not have the authority to halt the program or to keep it on hold indefinitely. Should the program be re-implemented with changes that would require revisions to the bid form, we will edit this information collection document to reflect any statutory or regulatory changes that may be made to the program, and will re-submit this PRA package for approval.

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Authorizing Statute(s): PL: Pub.L. 108 - 173 303(d)(1) Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   PL: Pub.L. 109 - 432 108 Name of Law: MIEA-TRHCA 2006
   US Code: 42 USC 1395w-3b Name of Law: Competitive acquisition of outpatient drugs and biologicals
  

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:
	74 FR 11958	03/20/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 27040	06/05/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Medicare Part B Drug and Biological Competitive Acquisition Program Applications	CMS-10133	Medicare Competitive Acquisition Program

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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	10	12	0	0	-2	0
Annual Time Burden (Hours)	1	480	0	0	-479	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:

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Annual Cost to Federal Government: $0

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)? No

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: 06/24/2009

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