Medication Therapy Management Program Improvements - Standardized Format (CMS-10396)

Forms and Documents

Document Name	Status
Form CMS-10396 Conducting CMRs with the standardized format and Fulfillment burden Form	Modified
Form CMS-10396 Training MTM providers to use the standardized format Form and Instruction	Removed
Form CMS-10396 Programming the standardized format Form and Instruction	Removed
CMS-10396 - Supporting Statement A [rev 4-14-2014 by OSORA PRA].docx Supporting Statement A	2014-04-16
5_Responses to 60 Day Comments_CMS-10396_04-01-2014.docx Supplementary Document	2014-04-16

IC Document Collections

IC ID	Document Title	Status
199672	Conducting CMRs with the standardized format and Fulfillment burden Form	Modified
199671	Training MTM providers to use the standardized format Form and Instruction	Removed
199670	Programming the standardized format Form and Instruction	Removed

ICR Details

OMB Control No: 0938-1154	ICR Reference No: 201404-0938-004
Status: Historical Active	Previous ICR Reference No: 201110-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medication Therapy Management Program Improvements - Standardized Format (CMS-10396)
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: 07/03/2014
	Date Received in OIRA: 04/16/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	36 Months From Approved	01/31/2015
Responses	280,352	0	1,876,346
Time Burden (Hours)	186,901	0	1,179,894
Cost Burden (Dollars)	255,120	0	1,706,250

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Abstract: The MMA of 2003 under title 42 CFR Part 423, Subpart D, established the requirements that Part D sponsors must meet with regard to medication therapy management (MTM) programs. Beginning in 2010, sponsors must offer an interactive, person-to-person comprehensive medication review (CMR) by a pharmacist or other qualified provider at least annually. A CMR is a review of a beneficiary's medications, including prescription and over-the-counter (OTC) medications, herbal therapies, and dietary supplements, which is intended to aid in assessing medication therapy and optimizing patient outcomes. Sponsors must summarize the CMR and provide an individualized written or printed summary to the beneficiary. The burden associated with the time and effort necessary for Part D sponsors to conduct CMRs with written summaries was estimated previously (RIN 0938-AP77, OCN: 0938-0964).The ACA under Section 10328 specifies that the Secretary, in consultation with relevant stakeholders, develop a standardized format for the action plan and written or printed summary that are given to beneficiaries as a result of their CMRs. The standardized format will replace whatever formats Part D sponsors are using for their written CMR summaries and action plans prior to 2013. Beginning in January, 2013, Part D sponsors will collect information required by the new standardized format, and provide that information to Medicare beneficiaries after their CMRs on forms that comply with the requirements specified by CMS for the standardized format (RIN 0938-AQ00). The use of the standardized format will support a uniform and consistent level of MTMP communications with beneficiaries, improve the ability of beneficiaries to understand and manage their medications safely and effectively, and support improved healthcare outcomes and lower overall healthcare costs. The final standardized format will be posted in the 2013 Call Letter for implementation by Part D sponsors in January 2013.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 10328 Name of Law: Improvement In Part D Medication Therapy Management (MTM) Programs
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 10328 Name of Law: Improvement In Part D Medication Therapy Management (MTM) Programs

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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:
	79 FR 3207	01/17/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 20209	04/11/2014
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Conducting CMRs with the standardized format and Fulfillment burden	CMS-10396	Medication Therapy Management Program Standardized Format
Programming the standardized format	CMS-10396	MEDICATION THERAPY MANAGEMENT PROGRAM STANDARDIZED FORMAT
Training MTM providers to use the standardized format	CMS-10396	MEDICATION THERAPY MANAGEMENT PROGRAM STANDARDIZED FORMAT

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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	280,352	1,876,346	0	-1,594,648	-1,346	0
Annual Time Burden (Hours)	186,901	1,179,894	0	-906,849	-86,144	0
Annual Cost Burden (Dollars)	255,120	1,706,250	0	-1,451,130	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The previous submission included burden for programing systems and for training MTM providers. In this current package we are removing that burden since the systems programming and staff training that were needed for the initial, startup implementation of the new standardized format for 2013, is no longer required and because this package's proposed revisions are nonmaterial. We have also adjusted burden estimates that are based on an estimate of the increased number of Part D enrollees through 2014 and 5 additional minutes for delivery of the CMR with summary in standardized format; and average eligibility rate for participation in Part D MTM programs, opt-out rate of eligible beneficiaries, and delivery rate of CMRs with summaries in standardized format. The net result is a lower estimate of the annual number of CMRs delivered (280,352) compared to the previous estimate (1,875,000). The nonmaterial revisions to the standardized format will neither add nor detract from the information collection burden.

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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]? Yes

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: 04/16/2014

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