CMS-10823 Appendix J

Appendix J: Informed Consent
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-XXXX (Expires XX/XX/XXXX). This is a voluntary information collection.
The time required to complete this information collection is estimated to average 30 to 60 minutes
per response, including the time to review instructions, search existing data resources, gather the
data needed, and complete and review the information collection. 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. Please do not send applications, claims, payments, medical records or any
documents containing sensitive information to the PRA Reports Clearance Office. Please note that
any correspondence not pertaining to the information collection burden approved under the
associated OMB control number listed on this form will not be reviewed, forwarded, or retained. If
you have questions or concerns regarding where to submit your documents, please contact
Christopher King at [email protected] or (410) 786-6972.
[These participant consent forms will be sent to participants prior to the scheduled interview and read
aloud to them at the start of each interview. The interviewer will obtain recorded, verbal consent before
continuing the interview beyond this point.]

J.1. Patient Consent Form
Project Overview
The Centers for Medicare & Medicaid Services (CMS), the agency that runs Medicare, put in place the
ESRD Quality Incentive Program (QIP) in 2012 to improve the quality of ESRD treatment. The broad goals
of the ESRD QIP are to encourage patient and family-centered care and improve patient health. We are
talking to dialysis patients about their experiences receiving ESRD treatment, learn about what is going
well and what should be improved.
Informed Consent
Insight will conduct interviews with patients and dialysis providers to gain an in-depth perspective of the
patient experience of care in ESRD. Information gathered during these interviews will provide a
foundation for future directions of ESRD care related to operational challenges, addressing patient
needs, and identifying best practices in ESRD treatment, patient engagement, and coordination of care.


Your participation is voluntary. You don’t have to answer any questions you don’t want to
answer.



After the call, you will receive $50 as a thank-you for your time.



What you say on this call will be considered private. Nothing you say will ever be linked to your
name, and nothing you say will affect your Medicaid or Medicare benefits if you currently
receive them.



We will summarize what we talk about today and put it together with information we will gather
from other calls just like this.

Insight ▪ ESRD QIP Informed Consent

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

We will use the information you share with us for research purposes only.



All information identifying you is stored securely and will be destroyed at the end of the study.

For additional information about the study, you can contact Carla Bozzolo at Insight Policy Research at
(571) 758-5036 or [email protected].

J.2. Non-Patient Consent Form
Project Overview
The Centers for Medicare & Medicaid Services (CMS) implemented the ESRD Quality Incentive Program
(QIP) in 2012 to improve the quality and efficiency of ESRD treatment. The broad goals of the ESRD QIP
are to encourage patient- and family-centered care, improve patient health and outcomes, and reduce
costs. The QIP is intended to improve the efficiency and quality of ESRD services and was developed to
mitigate potential change sin practices by dialysis facilities resulting from the institution of the ESRD
Prospective Payment System (PPS).
Informed Consent
Insight will conduct interviews with patients and dialysis providers to gain an in-depth perspective of the
patient experience of care in ESRD. Information gathered during these interviews will provide a
foundation for future directions of ESRD care related to operational challenges, addressing patient
needs, and identifying best practices in ESRD treatment, patient engagement and access, and
coordination of care.


We will use the information you share with us for research purposes only.



All your responses will be kept confidential. No one except the Insight research team will have
access to the information you provide.



We will use your answers to produce summaries from our collective set of interviews.



We will not report information in any way that identifies you or the organization you are
affiliated with to anyone outside the research team, except with your permission or as required
by law. CMS will not see your name or your organization’s name connected to your individual
responses.



All information identifying you is stored securely and will be destroyed at the end of the study.



We’d also like to emphasize that your participation is completely voluntary:


Your participation or nonparticipation will not be reported to anyone.



You can stop the interview at any time for any reason, and you can decline to discuss any
topic we raise.

For additional information about the study, you can contact Carla Bozzolo at Insight Policy Research at
(571) 758-5036 or [email protected].

Insight ▪ ESRD QIP Informed Consent

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