In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
12/31/2027
36 Months From Approved
12/31/2027
4,677,285
0
4,677,285
3,118,346
0
3,118,346
4,780,185
0
4,780,185
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
This iteration is associated with our December 10, 2024 (89 FR 99340) NPRM (CMS-4208-P, RIN 0938-AV40) which proposes to include other dementias (in addition to Alzheimerâs, which is one of the current core chronic diseases) in the core chronic diseases that sponsors must include in their targeting criteria for MTM program enrollment. The proposed change has no impact on the content of the Standardized Format document, but we estimate that the burden would increase due to a larger MTM program size. See section 15 of the attached Supporting Statement for details.
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.
CMS-10396_Supporting Statement_A (CMS-4208-P version 4).docx
Conducting CMRs with the standardized format and Fulfillment burden