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

ICR 201704-0938-006

OMB: 0938-1154

Federal Form Document

Forms and Documents
Supplementary Document
Supporting Statement A
IC Document Collections
ICR Details
0938-1154 201704-0938-006
Active 201404-0938-004
Medication Therapy Management Program Improvements - Standardized Format (CMS-10396)
Extension without change of a currently approved collection   No
Approved with change 08/15/2017
Retrieve Notice of Action (NOA) 04/26/2017
  Inventory as of this Action Requested Previously Approved
08/31/2020 36 Months From Approved 08/31/2017
1,211,661 0 280,352
807,774 0 186,901
1,696,325 0 255,120

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.

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

Not associated with rulemaking

  81 FR 75406 10/31/2016
82 FR 11222 02/21/2017

IC Title Form No. Form Name
Conducting CMRs with the standardized format and Fulfillment 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 1,211,661 280,352 0 0 931,309 0
Annual Time Burden (Hours) 807,774 186,901 0 0 620,873 0
Annual Cost Burden (Dollars) 1,696,325 255,120 0 0 1,441,205 0
There are no changes to Standardized Format document. This submission adjusts our burden estimates based upon increased postage rates and other mailing costs that were not included in previous submissions, in addition to an increase in number of CMRs since 2014.

Mitch Bryman 410 786-5258 [email protected]


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:
    (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;
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.

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