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

ICR 202104-0938-012

OMB: 0938-1154

Federal Form Document

Forms and Documents
Supplementary Document
Supporting Statement A
Supplementary Document
IC Document Collections
ICR Details
0938-1154 202104-0938-012
Received in OIRA 202012-0938-009
Medication Therapy Management Program Improvements - Standardized Format (CMS-10396)
Revision of a currently approved collection   No
Regular 05/14/2021
  Requested Previously Approved
36 Months From Approved 02/29/2024
2,386,955 2,173,254
1,591,383 1,448,908
2,219,868 0

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

Not associated with rulemaking

  85 FR 9002 02/18/2020
86 FR 26521 05/14/2021

IC Title Form No. Form Name
Conducting CMRs with the standardized format and Fulfillment burden

  Total Request 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 2,386,955 2,173,254 0 213,701 0 0
Annual Time Burden (Hours) 1,591,383 1,448,908 0 142,475 0 0
Annual Cost Burden (Dollars) 2,219,868 0 0 2,219,868 0 0
Miscellaneous Actions
This collection of information request is associated with our final rule that published in the Federal Register on January 19, 2021 (86 FR 5864) as CMS-4190-F2 (RIN 0938-AT97). As explained below in section 8, it is also associated with a non-rule 30-day notice that published on May 14, 2021 (86 FR 26521). We are submitting this request to OMB under the non-rule 30-day notice to accommodate the public comment process and sync with ROCIS. We estimate that the number of CMRs will increase from 2,173,254 (2021 estimate) to 2,386,955 for the 2022 estimate, an increase of 213,701. The annual hours required for these CMRs increased from 1,448,908 (2021 estimate) to 1,591,383 hours for the 2022 estimate (increase of 142,475 hours). The total non-labor fulfillment cost has been added ($2,219,868 = $2,212,946 + $6,922). See section 15 of the Supporting Statement for details.

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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