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
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.
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.