Medicare Part B Drug and Biological Competitive Acquisition Program and Supporting Regulations in 42 CFR Sections 414.906, 414.908, 414.910, 414.914, 414.916, and 414.917

Forms and Documents

Document Name	Status
cap.osora.cms10145.FINAL2.supstate.doc Supporting Statement A	2008-04-25

IC Document Collections

IC ID	Document Title	Status
8810	Medicare Part B Drug and Biological Competitive Acquisition Program and Supporting Regulations in 42 CFR Sections 414.906, 414.908, 414.910, 414.914, 414.916, and 414.917 (CMS-10145)	Modified

ICR Details

OMB Control No: 0938-0954	ICR Reference No: 200805-0938-004
Status: Historical Active	Previous ICR Reference No: 200505-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Part B Drug and Biological Competitive Acquisition Program and Supporting Regulations in 42 CFR Sections 414.906, 414.908, 414.910, 414.914, 414.916, and 414.917
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: 06/12/2008
	Date Received in OIRA: 05/06/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved	07/31/2008
Responses	156,000	0	10
Time Burden (Hours)	31,188	0	80
Cost Burden (Dollars)	0	0	0

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Abstract: Section 303(d) of the MMA provides an alternative payment methodology for Part B covered drugs that are not paid on a cost or prospective payment basis. In particular, Section 303(d) of the MMA amends Title XVIII of the Social Security Act (the Act) by adding a new section 1847B, which establishes a competitive acquisition program for the acquisition of and payment for Part B covered drugs and biologicals furnished on or after January 1, 2006.

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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:
0938-AO65	Final or interim final rulemaking	72 FR 66260	11/27/2007

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 7560	02/08/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 22418	04/25/2008
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 and Supporting Regulations in 42 CFR Sections 414.906, 414.908, 414.910, 414.914, 414.916, and 414.917 (CMS-10145)

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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	156,000	10	0	155,990	0	0
Annual Time Burden (Hours)	31,188	80	0	31,108	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: The MIEA-TRHCA of 2006 required the implementation of a post pay review process. Operationally, this translates to the requirement that CAP vendors submit drug administration verification information to CMS or its agent, though this information collection requirement is exempt from the PRA. Additionally, 42 CFR 414.906 allows a CAP vendor to voluntarily submit requests to add or substitute drugs onto their CAP drug list as needed. This was not reflected in the original PRA package and has now been added. It is also exempt from the PRA. 42 CFR 414.908 requires data to be submitted to facilitate programmatic operations. This was mentioned in the original PRA package, but the language has been updated. 414.917 was added to reflect language that requires information collection but is exempt from the PRA. Please see the supporting statement for additional information.

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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)? 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: 05/06/2008

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