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Notice Testing Guide

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Notice Testing Guide
Astrin, Clarese (CMS/OC)
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2024-04-24
2026-10-10
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Notice Testing: Notice of Denial of Medicare Part D Drug Coverage
Dates: TBD upon OMB Clearance, Notice Testing Guide
Protocol (60 Minutes)
Agenda
    • Introduction (4 minutes)
    • Context Questions (3 minutes)
    • Review of notice (15-20 minutes)
    • Section-by-section review (30-35 minutes)
    • Wrap up (3 minutes)
Introduction (4 Minutes)
Thank you for joining me today. My name is [Moderator], and I work for a company called [company] in the Washington DC area. Our discussion today is part of a project sponsored by the Centers for Medicare & Medicaid Services (CMS), the agency that runs the Medicare and Medicaid programs. We are helping them to gather information to improve some of the notices that people who have Medicare might receive, and to make sure that these notices are easy to understand and use.
In a few moments, I am going to share a notice with you to read and then I’ll ask some questions about the notice, but before I do that, I’d like make sure that you are aware of a few things:
    1. Your participation today is completely voluntary. You can decide not to answer any question that we ask, and you can stop your participation at any time. Your participation or decision to stop participating will have no impact on your Medicare benefits.
    2. The information you share will be combined with information from other people, your full name will not be connected with anything you say, and your privacy will be protected.
    3. I did not create the notice we are testing, so you won’t hurt my feelings with any feedback. Also, there are no right or wrong answers. Please be open and honest with your reactions and your answers to my questions.
Informed Consent
Did you have a chance to review the consent form? Do you have any questions? Do we have your consent to participate? 
Some housekeeping items:
    1. We will be here for 60 minutes today. If you need to step away at any point, just let me know.
    2. Our discussion will be recorded so that we can make sure that we don’t miss anything that you tell us. The recording is only used for research purposes and will not be shared with anyone outside of our team.
[Begin recording]
Context Questions (3 Minutes)
Before I share the notice that we’ll be talking about, I have some questions about your Medicare coverage.
    1. Tell me about your Medicare coverage.
        a. (Probe if not mentioned) Do you have a Medicare Advantage plan or do you have Original or Traditional Medicare?
        b. (Probe if not mentioned) How do you get coverage for your medications? Do you have Part D drug coverage through your Medicare Advantage plan (if MA)? Do you have a stand-alone Part D plan (if Original/traditional Medicare)?
Review of the Notice (15-20 Minutes)
(Give the participant a highlighter, a pen, and a copy of the notice)
Thank you for sharing that information. Now, I’m going to give you a notice that you might receive from your [Medicare Advantage/Part D] plan. 
Imagine that you contacted your Medicare Plan and asked for coverage of a drug or reimbursement for a drug that you paid for out of pocket and  you were told that your [Medicare Advantage/Part D] plan would not cover or pay for that medication, and you received this notice from your plan. I would like for you to read the notice, and as you do, please use the highlighter to highlight any things that you find confusing or that you have questions about; use the pen to circle any things that you think are particularly important or are new information. When you are finished reading through the notice, let me know, and I’ll ask you some questions about it.
(Wait for participant to read through the notice)
First Impressions
    1. Now that you’ve read the notice, what do you think the main purpose of this notice is?
        a. (Probe if not mentioned) When do you think someone might receive this notice?
    2. What is the most important information in this notice?
    3. If you received this notice, what do you think you would do next?
        a. (Probe if not mentioned) How you would do that?
    4. If you needed help or more information, what would you do?
Review of Confusing and Important Information
    1. Let’s talk through the things that you highlighted as you read:
        a. For each highlighted word/phrase: You highlighted [word/phrase]: 
            i. What is confusing about this?
            ii. What do you think this might mean?
    2. Now, let’s look at the things you circled as you read:
        a. For each circled word/phrase: You circled [word/phrase]:
            i. What makes this information important?
Section-by-Section Review (30-35 Minutes)
Now, let’s go over each section of the notice and talk about what they mean.
    1. “Your request was denied”
        a. According to this notice, tell me what request was denied.
    2. “Why did we deny your request?”
        a. In your own words, tell me why the request was denied.
            i. Do you need any additional information to understand why the request was denied?
        b. What do you think it means that the drug “may be covered under Medicare Part A or Part B”?
            i. Who is “your prescriber”?
        c. According to this part of the notice, what should you do next? (NOTE: Notice says to share a copy of the decision with prescriber and discuss next steps)
    3. “Important information about your appeal rights”
        a. “You have the right to appeal this decision”
            i. According to this notice, what should you do if you want to appeal the decision?
                1. (Probe if not mentioned) How long do you have to ask for an appeal?
            ii. What are the exceptions that you can ask for?
                1. What does each one mean? 
                    a. Formulary exception
                    b. Coverage rule exception
                    c. Tiering exception
                2. How might you know which one to ask for?
        b. “Who can ask for an appeal?”
            i. Who can ask for an appeal?
            ii. Why do you think there is information about appointing a representative here?
            iii. What do you think of having this information here (before kind  of appeal)?
        c. “There are 2 kinds of appeals you can ask for”
            i. What are the two kinds  of appeals you can ask for?
                1. What are the differences between these two kinds of appeals?
                2. How would you request an expedited appeal?
                    a. How long would it take for you to get a decision for an expedited appeal?
                    b. What happens if your appeal is not expedited? (Probe if not mentioned) how long would it take for you to get a decision?
                3. How long would it take to get a decision if you asked for a standard appeal?
                    a. What do you think it means that you must get a decision within 7 days? 
                    b. Are there any times when you would not get a decision within 7 days? Where it could take longer than 7 days?
        d. “How to ask for an appeal”
            i. What is the fastest way to get an appeal? 
                1. Can you do this for both an expedited and standard appeal?
        e. “Here’s what to include with your appeal request”
            i. What do you think would be “evidence” to include?
            ii. Give me an example of when you would be asking for an exception to a coverage rule.
                1. What information do you need to include with that type of appeal? 
            iii. Give me an example of when you would ask for a formulary exception.
                1. What information do you need to include with that type of appeal?
            iv. Give me an example of when you would  ask for a tiering exception.
                1. What information do you need to include with that type of appeal?
        f. What happens next
            i. What happens after you appeal?
Wrap Up (3 Minutes)
Thank you for sharing that great information. We are almost finished.
Now that you’ve had a chance to read the notice, and to talk about each section:
    1. How easy or difficult do you think it is to understand this notice? 
        a. What makes you say that?
    2. What could be changed to make this notice better?


PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1382 GenIC #9. This information collection is being conducted to help improve informational notices for people with Medicare and the results will be used to ensure that people with Medicare understand important information about their plans. The time required to complete this information collection is estimated to average less than 60 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, to review and complete the information collection. This information collection is voluntary and CMS will keep the information private to the extent provided by law. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.