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OMB Control No: 0938-1154	ICR Reference No: 202104-0938-012
Status: Historical Active	Previous ICR Reference No: 202012-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
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 with change	Conclusion Date: 10/15/2021
	Date Received in OIRA: 05/14/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2024	36 Months From Approved	02/29/2024
Responses	2,386,955	0	2,173,254
Time Burden (Hours)	1,591,383	0	1,448,908
Cost Burden (Dollars)	2,219,868	0	0

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.

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: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 9002	02/18/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 26521	05/14/2021
Did the Agency receive public comments on this ICR? Yes

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

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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	2,386,955	2,173,254	213,701
Annual Time Burden (Hours)	1,591,383	1,448,908	142,475
Annual Cost Burden (Dollars)	2,219,868	0	2,219,868

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: 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 regulations.gov 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.

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. 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? No

Agency Contact: Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov

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