Supporting Statement

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0938-1185)

title of information collection:

Telephone interview instrument for soliciting feedback on satisfaction with and changes to the Standardized Format (CMS Form 10396, OCN 0938-1154)

purpose:

Information about Medicare Part D beneficiaries’ satisfaction and suggested revisions to the summary documents associated with the comprehensive medication review (CMR) will be collected in order to determine how these documents should be revised. This collection is designed to make changes based on what the end users (i.e., Medicare beneficiaries) would like to see made. Responses will be used to help generate a list of recommended revisions that will be presented to CMS for consideration, and inform revisions, if needed, to the Standardized Format for inclusion in a standard Paperwork Reduction Act (PRA) package with the requisite 60- and 30-day comment periods.

description of respondents:

Respondents are Medicare beneficiaries who have Part D coverage and who meet Medication Therapy Management Program eligibility criteria.

type of collection: (Check one)

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software) [ ] Small Discussion Group

[ ] Focus Group [x] Other: Phone interviews

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name: Cynthia G. Tudor, Ph.D., Deputy Director, Center for Medicare

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ ] Yes [x] No

2. If Yes, will any information that is collected be included in records that are subject to the Privacy Act of 1974? [ ] Yes [ ] No

3. If Yes, has an up-to-date System of Records Notice (SORN) been published? [ ] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [x] No

BURDEN HOURS

Category of Respondent	No. of Respondents	Participation Time	Burden
(1) Individuals	30	20	10
Totals	30	20	10

federal cost: The estimated annual cost to the Federal Government is $9,000.00

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targets respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting this universe? [ ] Yes [x] No

If the answer is yes, please provide a description of both below (or attach a sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

In previous research we conducted related to medication therapy management and in conjunction with CMS, we devised a recruitment strategy that will enable us to find and solicit Medicare beneficiaries who meet the interview inclusion criteria we have set up for this data collection initiative. We will approach Medicare Part D plans and medication therapy management providers we have worked with in the recent past to help us identify a pool of eligible Medicare beneficiaries who:

1. Are enrolled in the Medication Therapy Management Program.

2. Have received a CMR and summary documents at least once.

3. Have contact information (address and phone number) available to us in order to contact them for recruitment and interviewing purposes.

If this recruitment method does not provide approximately thirty beneficiaries for the telephone interviews, we may solicit additional participants that are identified in the Part D MTM data file submitted to CMS in accordance with the annual Part D Reporting Requirements.

Using these sources of data we will stratify the pool geographically in the contiguous United States¹ into the Census Bureau-designated regions (i.e., Northeast, South, Midwest, and West) to ensure representativeness and then randomly select potential study participants, with eight potential participants each coming from the Northeast and South regions and seven each coming from the West and Midwest regions. These distributions conform to the relative population sizes of the four regions.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[x] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? Interviewers [x] Yes [ ] No; Facilitators [ ] Yes [x] No.

Please make sure that all instruments, instructions, and scripts are submitted with the request.

Instructions for completing Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback”

Title of information collection: Provide the name of the collection that is the subject of the request (e.g., Comment card for soliciting feedback on xxxx)

purpose: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

description of respondents: Provide a brief description of the targeted group or groups for this collection of information. These groups must have experience with the program.

type of collection: Check one box. If you are requesting approval of other instruments under the generic, you must complete a form for each instrument.

certification: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

Personally Identifiable Information: Provide answers to the questions. Note: Agencies should only collect PII to the extent necessary, and they should only retain PII for the period of time that is necessary to achieve a specific objective.

Gifts or Payments: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

burden hours:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households; (2) Private Sector; (3) State, local, or tribal governments; or (4) Federal Government. Only one type of respondent can be selected per row.

No. of Respondents: Provide an estimate of the Number of Respondents.

Participation Time: Provide an estimate of the amount of time (in minutes) required for a respondent to participate (e.g., fill out a survey or participate in a focus group).

Burden: Provide the Annual burden hours: Multiply the Number of Respondents and the Participation Time then divide by 60.

federal cost: Provide an estimate of the annual cost to the Federal government.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targets respondents. Please provide a description of how you plan to identify your potential group of respondents and how you will select them. If the answer is yes, to the first question, you may provide the sampling plan in an attachment.

Administration of the Instrument. Identify how the information will be collected. More than one box may be checked. Indicate whether there will be interviewers (e.g., for surveys) or facilitators (e.g., for focus groups) used.

Submit all instruments, instructions, and scripts with the request.

1 Due to large time zone variances, we will exclude Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands from participation.

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