Changes to Close the Part D Coverage Gap, Improvements to MTM Programs, Independence of LTC Consultant Pharmacists

Forms and Documents

Document Name	Status
Supporting Statement - Combined.doc Supporting Statement A	2010-11-17

IC Document Collections

IC ID	Document Title	Status
195592	Improvements to Medication Therapy Management (MTM) Programs (Start-up)	New
195591	Improvements to Medication Therapy Management (MTM) Programs (Annual)	New
195590	Changes to Close the Part D Coverage Gap ( Start-up)	New
195589	Changes to Close the Part D Coverage Gap (Annual)	New
195588	Independence of LTC Consultant Pharmacists (CMS-10348)	New

ICR Details

OMB Control No: 0938-1337	ICR Reference No: 201012-0938-007
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Changes to Close the Part D Coverage Gap, Improvements to MTM Programs, Independence of LTC Consultant Pharmacists
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: Comment filed on proposed rule	Conclusion Date: 02/03/2011
	Date Received in OIRA: 12/06/2010
Terms of Clearance: Upon re-submission, this ICR package should include any public comments submitted on the proposed rule that relate to these information collection requirements, and it should also reflect any changes made to these requirements in the final rule.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Paragraphs (b)(3) and (d) of section 1101of HCERA amended section 1860D 2(b) of the Act by adding provisions that revise the Part D benefit structure to close the gap in coverage that occurs between the initial coverage limit for the year and the out-of-pocket threshold. The new provisions not only revise the amount of coinsurance for costs of covered drugs above the initial coverage limit and below the out-of-pocket threshold (that is, within the Part D coverage gap), but also reduce the growth in the annual out-of-pocket threshold from 2014 to 2019.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1860 Name of Statute: null
   Statute at Large: 18 Stat. 1819 Name of Statute: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AQ00	Proposed rulemaking	75 FR 71190	11/22/2010

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Improvements to Medication Therapy Management (MTM) Programs (Start-up)
Independence of LTC Consultant Pharmacists (CMS-10348)
Changes to Close the Part D Coverage Gap (Annual)
Changes to Close the Part D Coverage Gap ( Start-up)
Improvements to Medication Therapy Management (MTM) Programs (Annual)

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The new provisions not only revise the amount of coinsurance for costs of covered drugs above the initial coverage limit and below the out-of-pocket threshold (that is, within the Part D coverage gap), but also reduce the growth in the annual out-of-pocket threshold from 2014 to 2019.

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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]? 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? 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: 12/06/2010

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