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Agency Information Collection Activities: Submission for OMB Review; Comment Request

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Centers for Medicare & Medicaid Services, HHS.




The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.


Comments on the collection(s) of information must be received by the OMB desk officer by August 17, 2020.


Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

1. Access CMS' website address at​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html.

2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Start Printed Page 43585

3. Call the Reports Clearance Office at (410) 786-1326.

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William Parham at (410) 786-4669.

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Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Medication Therapy Management Program Improvements—Standardized Format; Use: The Medicare Modernization Act of 2003 (MMA) under title 42 CFR part 423, subpart D, establishes the requirements that Part D sponsors, an organization which has one or more contract(s) with CMS to provide Part D benefits to Medicare beneficiaries, must meet with regard to cost control and quality improvement including requirements for medication therapy management (MTM) programs. MTM is a patient-centric and comprehensive approach to improve medication use, reduce the risk of adverse events, and improve medication adherence. At minimum, a Part D sponsors' MTM program must offer to its enrollees an annual comprehensive medication review with written summaries, quarterly targeted medication reviews, and follow-up interventions for both beneficiaries and prescribers when necessary.

Information collected by Part D MTM programs as required by the Standardized Format for the CMR summary, which is used by beneficiaries or their authorized representatives, caregivers, and their healthcare providers to improve medication use and achieve better healthcare outcomes. The Standardized Format must comply with applicable industry standards for medication therapy management and electronic data interchange, and should enable CMR data elements to be captured for clinical, reporting or measurement purposes.

After a CMR is performed, the sponsor creates and sends a summary of the CMR to the beneficiary that includes a medication action plan and personal medication list using the Standardized Format. The information users are beneficiaries or their authorized representatives, caregivers, and their healthcare providers as stated in this section. Form Number: CMS-10396 (OMB control number: 0938-1154); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 735; Total Annual Responses: 2,173,254; Total Annual Hours: 1,448,908. (For policy questions regarding this collection contact Victoria Dang at 410-786-3991.)

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Dated: July 14, 2020.

William N. Parham, III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.

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[FR Doc. 2020-15540 Filed 7-16-20; 8:45 am]