Cancer Trials Support Unit

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CTSU – A Service of the National Cancer Institute

National Coverage Analysis

Working Group Charter

Version 1.0

2 November 2015

Contents

1.1 Overview 3

1.2 Membership Structure 3

2.1 Scope 3

2.2 Meeting Schedule and Workshop 3

2.3 Communication 4

2.4 Meeting Material 4

3.1 Deliverables 4

3.2 Timeline 4

4.1 Leadership 4

4.2 Participants 4

4.3 Process for Replacing Participants 5

5.1 Revision Policy 5

Section 1

1.1  Overview

The National Cancer Institute (NCI) Cancer Therapy and Evaluation Program (CTEP) requested the formation of a working group to focus on the development of a standardized approach to Coverage Analysis (CA) development to facilitate the conduct of clinical research throughout the NCI-supported clinical research enterprise. NCI is asking that the CTSU develop a team that can review new protocols to assess what costs will be covered by the funding of the clinical trial, and to determine what costs from required imaging studies, lab tests, and other procedures may be covered by Medicare as ‘routine costs’, and what will be absorbed by the study participant. Concerns about providing coverage analysis support from the Group and Research Bases include lack of expertise, resources, and time, as well as the concern over liability. As part of this effort, a working group was formed to assess and advise on a standard process for coverage analysis development. The Coverage Analysis support that will be provided by the CTSU staff will be for NCI-supported NCTN and DCP trials and will be made available for all institutions participating on these trials.

1.2  Membership Structure

The Coverage Analysis Working Group will be facilitated by Lucille Patrichuk and Lawrence Ragard. As needed each group represented in the working group will assign one voting participant. The voting participant must be able to make decisions related to the Coverage Analysis Working Group on behalf of their organization. If the voting participant is not able to regularly participate on calls, it is recommended that their organization assign a non-voting representative or another designee to ensure that the appropriate people remain informed about the activities of the Working Group.

Section 2

2.1 Scope

The Coverage Analysis Working Group (CAWG) will define a procedure for the development of Coverage Analysis documents to be used across the NCTN Network Groups and Research Bases. The CAWG, along with consultants such as K. Willenberg, will define the requirements necessary to develop a standardized coverage analysis template as well as develop a plan for the implementation of the Coverage Analysis process across the organizations.

2.2 Meeting Schedule

The CAWG will meet at least twice per month for a minimum of one hour. The initial schedule of the meeting will be the first and third Mondays of the month. Meetings will be conducted via web conferencing and teleconference as determined by the working group leads. The frequency of the meetings may be increased or decreased as needed.

2.3 Communication

Communication mechanisms to be employed within the working group include email, web conferencing and phone.

2.4 Meeting Material

Meeting material will be posted to the Collaboration Portal of the CTSU website for each meeting: CTSU Website > Collaboration Portal > Coverage Analysis Working Group (CAWG).

Section 3

3.1 Deliverables

Deliverable Number / Description
#1 / Identify roles and responsibilities for Coverage Analysis development
#2 / Develop a SOP for CA development
#3 / Prioritize trials and detemine the timing of the CA
#4 / Develop the CA Template
#5 / Identify a trial for piloting new process
#6 / Implement pilot and obtain feedback

3.2 Timeline

The CAWG would like to finalize these deliverables by March 2016.

Section 4

4.1 Leadership

Lucille Patrichuk and Lawrence Ragard from the CTSU are the facilitators/co-leaders for the CAWG.

4.2 Participants

The roster for the CAWG is located at:

CTSU Website > Collaboration Portal > Coverage Analysis> General Documents.

4.3 Process for Replacing Participants

Lawrence Ragard will facilitate adding or removing participants from the Coverage Analysis Working Group. Please email your request to the co-leads/facilitators for the CAWG, Lucille Patrichuk and Lawrence Ragard. Please make sure participants in the Working Group are the key decision makers in regards to the coverage analysis for your organization.

Section 5

5.1 Revision Policy

As processes, procedures and task assignments are developed and modified the CA Working Group Charter will be updated and revised to reflect the changes.

Version / Updated by / Approval Date / Next Review Date
1.0

National Coverage Analysis Charter Version 1.0 2November2015 Page 3 of 5