RFTP 001 MedicareCancerAtlas.pdf

Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention National Center for Chronic Disease Prevention and Health Promotion (NCCD) Division of Cancer Prevention and Control (DCPC) Atlanta, GA 30333

DATE ISSUED: April 14, 2008 DATE RESPONSE DUE: May 15, 2008

REQUEST FOR TASK ORDER PROPOSAL (RFTP) NO: 001

TITLE: Medicare Cancer Atlas

Contract Reference: This RFTP is consistent with the tasks in section C.4(1)(B) – Research Support contained in RFP 2008-N-10240.

Funding Range:

X Less than $100,000 More than $100,000 but less than $300,000 More than $300,000 but less than $500,000 More than $500,000 but less than $750,000 More than $750,000 but less than $1,000,000 More than $1,000,000

Technical Proposal Preparation:

The contractor should prepare a technical proposal which demonstrates an understanding of the project and all tasks defined. Additionally, the proposal should address all evaluation criteria.

The proposal should not exceed a total of 15 single-spaced typewritten pages excluding resumes and charts which are within appendices. Resumes shall not exceed 3 pages per proposed staff member.

Budget Format Suggestion:

The contractor shall prepare a cost proposal breakdown for each task identified as well as a summary of all tasks. A budget narrative shall be furnished for explanation of costs as required.

A. BACKGROUND AND NEED

Medicare datasets include a large amount of information that potentially might be useful in addition to state Comprehensive Cancer Control (CCC) planning projects. However, Medicare datasets also are relatively complex and state CCC programs do not have guidelines on how to best design an atlas of cancer-related Medicare data.

The Center for Clinical Evaluative Services at Dartmouth Medical School has published a number of reports/atlases that illustrate how Medicare data (http:www.dartmouthatlas.org) can be used to evaluate several dimensions of healthcare. However, to date, none of the Dartmouth reports/atlases have focused specifically on how Medicare data might be applied as part of state CCC planning projects. The Dartmouth reports/atlases have not specifically considered whether a state-based CCC cancer atlas should display Medicare data alone, versus Medicare data linked with state central cancer registry data.

This project will provide practical information for state CCC programs on the use of Medicare data as part of CCC planning projects.

B. OBJECTIVE

The objective of this project is to develop a protocol for a Medicare Cancer Atlas in one or more States. The protocol will include providing details on: 1) the specific cancers or cancer-related procedures for the atlas; 2) methods; 3) datasets; 4) time period to be covered by the atlas; 5) issues related to costs to acquire datasets; 6) issues related to obtaining access to datasets; 7) issues related to costs to update datasets in the atlas over time; 8) quality of care indicators; 9) variation in Medicare charges; 10) cancer-related health care resources; 11) methods to protect privacy and confidentiality of cancer patients; 12) geographic units; 13) spatial analysis methods; 14) validation that the atlas is based on accurate and reliable information; 15) titles of proposed tables, figures and maps; 16) a line item budget for estimated costs to develop this type of atlas; and 17) details on the time/staff needed to develop the atlas.

Specific research questions for a state-level Medicare Cancer Atlas include:

1) What data and methods should be used for surveillance of trends in different types of cancer, cancer surgery, radiation therapy, chemotherapy use, or complications of cancer treatment?

2) Can Medicare data alone (e.g. from the Chronic Condition Data Warehouse;

http://www,resdac.umn.edu/CCW/Index.asp) be used for some topics or does the atlas need to be based upon Medicare data linked with state central registry data?

3) What quality of care indicators should be used?

4) What methods should be used for analysis of variation in Medicare charges, and to provide information for state policy makers to determine the economic burden of specific types of cancers in their states, and to realize potential cost savings from focusing proven interventions on those diseases?

5) What methods should be used to protect the privacy and confidentiality of cancer patients?

6) What geographic units and spatial analysis methods should be used?

7) What tables, figures, and maps would be most useful in terms of providing useful insights for CCC interventions?

This project will focus on one or more states who will agree to become active partners in the project. This project will provide practical information for state CCC programs on the use of Medicare data as a part of CCC planning projects.

C. SCOPE OF WORK

The contractor shall provide all labor, equipment, materials, supplies, and supervision to perform the required tasks and produce the desired deliverables identified below under Description of Work and Deliverables Sections below.

D. DESCRIPTION OF WORK

Specific tasks:

1. Develop weekly communication with the Technical Monitor. Within 1 week of the task order award, the contractor shall create a schedule of weekly conference calls with the Technical Monitor (to be modified when the state CCC program partner(s) is identified and brought into the study).

The contractor shall email brief weekly reports (<1 page) summarizing all communication with CDC staff, state CCC staff, and activities related to the task order to the Technical Monitor on the first business day following a conference call, beginning 1 week after the task order is awarded.

2. Selecting state CCC programs and state cancer registry. Within 4 weeks of the task order award, the contractor, with input and approval from the CDC staff, shall choose among potential state CCC programs and cancer registries and establish the partnership relationship/agreements under which they will operate. Specifically, the contractor will be responsible for:

a. Identifying potential partners and securing approval of the selection of the final participants.

b. Putting into place an agreement with the selected CCC program and state cancer registry.

c. Working with the state cancer registry and the CDC team to prepare and submit any necessary CDC or State IRB applications, and to prepare any necessary CMS data request packets and data use agreements that would need to be reviewed by the Research Data Assistance Center (ResDAC) (http://www.resdac.umn.edu.Index.asp) at the University of Minnesota.

http://www.resdac.umn.edu.index.asp/

3. The contractor shall schedule and conduct monthly telephone conferences or meetings to obtain comments on the atlas design and methods from the state CCC program, state central cancer registry and CDC Technical Monitor.

The contractor, with input from the participating state(s) and the Technical Monitor shall evaluate which topics can be addressed with Medicare data alone (e.g. from the Chronic Condition Data Warehouse), which topics need to be addressed with Medicare data linked with state central cancer registry data, or whether some topics might benefit from analysis and comparison of both types of data. The Medicare Chronic Condition Data Warehouse (CCW) includes 100% of the Medicare population after January 1, 2005, and had predefined the following cancers: breast, colorectal, prostate, lung and endometrial (http://www.resdac.umn.edu.CCW/ccw_rif_data_available.asp).

Researchers potentially can use custom definitions to request a cohort based on unique criteria provided (e.g., all claims for a particular procedure, diagnosis, or specified population). For example, information potentially could be requested to provide insights about hematologic cancers (lymphoma/leukemia) and selected cancer-related screening procedures (e.g. percent of Medicare women age 65-90 who had mammograms). The CCW includes data down to the ZIP code level of geography.

4. The contractor shall develop a protocol for a Medicare Cancer Atlas for approval of the CDC IRB. Appendix I provides an outline of the topics that the CDC IRB likes to see addressed in a research protocol. In addition, the contractor shall develop drafts of any necessary CMS data request packets and data use agreements that would need to be reviewed by the University of Minnesota Research Data Assistance Center (ResDAC) (http://www.resdac.umn.edc.Index ,asp). The draft protocol, data request packets and data use agreements shall be completed and submitted to the Technical Monitor and the state partners for review within 90 days after award of the task order.

The contractor shall incorporate recommended changes into these drafts.

5. Within 120 calendar days after award of the task order, the contractor shall identify and convene a panel of 3 external scientific review the draft protocol. The contractor shall prepare minutes of the scientific review panel meeting and shall provide a copy of the minutes to the Technical Monitor.

6. Within 180 calendar days after award of the task order, the contractor shall incorporate the comments of the external scientific reviewers to review and shall provide the second draft protocol, data request packet and data use agreements to the Technical Monitor.

7. Within 30 days after receipt of comments of the CDC IRB, the contractor shall make the final changes to the protocol necessary to obtain the final CDC IRB approval. Also, within 30 days after receipt of comments from ResDAC, the contractor shall make the final changes to the CMS data request packet and data use agreements necessary to obtain final ResDAC approval.

http://www.resdac.umn.edu.ccw/ccw_rif_data_available.asp)

8. Within 320 days after award of the task order, the contractor shall provide an Executive Summary of conclusions about the optimal design for a Medicare Cancer Atlas that would add value to state CCC planning projects.

E. DELIVERABLES

TASK NO. DESCRIPTION TIME FOR DELIVERY

1 Weekly reports Beginning 1 week after award and continuing throughout the performance of the task order

4 First Draft of Protocol, data request packets and data use agreements

120 days after award of task order

5 Minutes of External Scientific Review

30 days after review meeting

6 Second Draft Protocol 180 days after award of task order

7 Final Protocol with CDC IRB approval, CMS data request packet and data use agreements

365 days after award of task order

8 Executive Summary Within 320 days after task order award

All documents listed as deliverables shall be submitted to the Technical Monitor and the Project Officer on paper (1 hard copy to each) and as electronic files (e.g., MS Word, Access, or Excel in a PC compatible format). All other deliverables shall be submitted in the format specified by the Project Officer or Technical Monitor.

F. PERIOD OF PERFORMANCE

The period of performance shall be 365 days from the effective date of task order award.

G. RIGHTS IN DATA

The following pre-award Federal Acquisition Regulation (FAR) provisions apply to this request for task order proposal, and are hereby incorporated by reference:

Number Title Date

FAR 52.227-17 Rights in Data—Special Works Dec 2007

CDC will assume principal scientific leadership for the project. It is expected that at the completion of the project, data will remain within DCPC and will be available to CDC staff for data analyses and publications. All data generated under this task order shall become and remain the property of CDC. The contractor may not use or publish from this data without prior written consent of the contracting officer.

H. PERFORMANCE MATRIX

Performance Based Matrix

Deliverable or Service Required

Measure of Success

Standards – Criteria for Acceptance

Method of Surveillance

Incentive1

Task C.4 (1)

(A)(1) Planning and Coordinating External Peer Review activities

1. Work Quality

2. Compliance

3. Accuracy

4. Timeliness

5. Business Relations

1. 100% of work products are technically correct with no correction required by the government.

2. 100% of all work products adhere to respective CDC and Federal government regulatory and statutory guidelines

3. 100% of all work products are accurate in presentation and adherence to accepted elements of style with no errors.

4. 100% of work products are completed, in ready state, on time as specified by CDC customer.

5. 100% of the time the contractor staffing demonstrates

Surveillance system will be primarily customer observations.

See QASP for details.

Payment of contract labor rate for satisfactory service.

Rating of “5” Outstanding, in the NIH Contractor Performance System (CPS) evaluation using annual Contractor Performance Report. The evaluation will be considered when future contract selections are made.

reasonable and cooperative behavior, a commitment to customer satisfaction, and a concern for the interest of the customer

Task C.4 (1)

(A)(2) Support Health Education Activities

1. 100% of work products are technically correct with no correction respective CDC and Federal government regulatory and statutory guidelines

3. 100% of all work products are accurate in presentation and adherence to accepted elements of style with no errors.

4. 100% of work products are completed, in ready state, on time as specified by CDC customer.

5. 100% of the time the contractor staffing demonstrates reasonable and cooperative behavior, a commitment to customer satisfaction, and a concern for the interest of the

Surveillance system will be primarily customer observations.

See QASP for details.

Payment of contract labor rate for satisfactory service.

Rating of “5” Outstanding, in the NIH Contractor Performance System (CPS) evaluation using annual Contractor Performance Report. The evaluation will be considered when future

(B)(1) Conduct Statistical Programming and Analysis

1. 100% of work products are technically correct with no correction respective CDC and Federal government regulatory and statutory guidelines

3. 100% of all work products are accurate in presentation and adherence to accepted elements of style with no errors.

4. 100% of work products are completed, in ready state, on time as specified by CDC customer.

5. 100% of the time the contractor staffing demonstrates reasonable and cooperative behavior, a commitment to customer satisfaction, and a concern for the interest of the customer

Surveillance system will be primarily customer observations.

See QASP for details.

Payment of contract labor rate for satisfactory service.

Rating of “5” Outstanding, in the NIH Contractor Performance System (CPS) evaluation using annual Contractor Performance Report. The evaluation will be considered when future

(B)(2) Scientific Publication Support

1. 100% of work products are technically correct with no correction respective CDC and Federal government accurate in presentation and adherence to accepted elements of style with no errors.

4. 100% of work completed, in ready state, on time as specified by CDC customer.

5. 100% of the time the contractor staffing demonstrates reasonable and cooperative behavior, a commitment to customer satisfaction, and a concern for the interest of the customer

Surveillance system will be primarily customer observations.

See QASP for details.

Payment of contract labor rate for satisfactory service.

Rating of “5” Outstanding, in the NIH Contractor Performance System (CPS) evaluation using annual Contractor Performance Report. The evaluation will be considered when future

(B)(3) Conduct Literature Reviews

1. 100% of work products are technically correct with no correction respective CDC and Federal government accurate in presentation and adherence to accepted elements of style with no errors.

4. 100% of work products are completed, in ready state, on time as specified by CDC customer.

5. 100% of the time the contractor staffing demonstrates reasonable and cooperative behavior, a commitment to customer satisfaction, and a concern for the interest of the customer

Surveillance system will be primarily customer observations.

See QASP for details.

Payment of contract labor rate for satisfactory service.

Rating of “5” Outstanding, in the NIH Contractor Performance System (CPS) evaluation using annual Contractor Performance Report. The evaluation will be considered when future

(C) Strategic Planning Services

1. 100% of work technically correct with no correction required by the government.

Surveillance system will be primarily customer observations.

See QASP for

Payment of contract labor rate for satisfactory service.

Rating of “5” Outstanding, in the NIH Contractor respective CDC and Federal government accurate in presentation and adherence to accepted elements of style with no errors.

4. 100% of work products are completed, in ready state, on time as specified by CDC customer.

5. 100% of the time staffing demonstrates reasonable and cooperative behavior, a commitment to customer satisfaction, and a concern for the interest of the customer details. Performance System (CPS) evaluation using annual Contractor Performance Report. The evaluation will be considered when future

Task C.4 (2)

The Contractor shall Follow the Task Order Award Process

1. Timeliness

1. 100% of Task Order proposals are submitted on time

Surveillance system will be primarily customer observations.

See QASP for details

Failure to follow the Task Order Award Process may result in loss of winning Task Order

2. Work Quality

2. 100% of Task Order proposals are technically compete as government

Task C.4 (3)

The Contractor shall provide a knowledgeable Project Director

1. Cost Control

2. Business

3. Management of Key Personnel

1. 100% of the time the contractor demonstrates attention to cost control, without sacrificing work quality

2. 100% of the time staffing demonstrates reasonable and cooperative behavior, a commitment to customer satisfaction, and a concern for the interest of the

3. 100% of the time, the contractor provided technical experts that were highly qualified and effective in performing the required services;

the appropriate number of personnel were assigned to the project; and the delivered products reflected the skill and standardization

Surveillance system will be primarily customer observations.

Payment of contract labor rate for satisfactory service.

Rating of “5” Outstanding, in the NIH Contractor Performance System (CPS) evaluation using annual Contractor Performance Report. The evaluation will be considered when future

Task C.4 (4)

The contractor shall meet with the Government at start of each task order

2. Business

1. 100% of Task Order Award meetings are conducted within the specified time

2. 100% of the time staffing demonstrates reasonable and cooperative behavior, a commitment to customer satisfaction, and a concern for the interest of the customer

Surveillance system will be primarily customer observations.

service.

Rating of “5” Outstanding, in the NIH Contractor Performance System (CPS) evaluation using annual Contractor Performance Report. The evaluation will be considered when future

Task C.4 (5)

The contractor shall provide monthly status report

2. Work Quality

1. 100% of Monthly Status reports are submitted on time

2. 100% of Monthly Status reports are submitted on time

Surveillance system will be primarily customer observations.

service.

Rating of “5” Outstanding, in the NIH Contractor Performance System (CPS) evaluation using annual Contractor Performance Report. The evaluation will be considered when future

I. EVALUATION CRITERIA

This task order shall be awarded to the offeror whose proposal is considered to be the most advantageous to the Government, price and other factors (identified below) considered. Technical Factors will be more important than cost in this evaluation. The Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance.

Technical Evaluation

Technical evaluations for this RFTP are as follows:

Criteria Value of Criteria

A. Staffing and Management ___30_ _____ B. Technical Approach ___25 ______ C. Similar or previous experience __ 45_ _

A. Staffing and Management

Contractors are to provide (1) a staffing plan that demonstrates an understanding of the labor requirements for this task order; and (2) a management plan that describes the approach for managing the work, to include subcontract management. Contractors should specify the Project Leader and Task Manager by name and indicate their degrees, areas of expertise and relevant experience. Contractors are to provide information reflecting experience of assigned staff that is appropriate to the complexity, size and subject matter of the proposed work and should include 1) development of IRB protocols, ResDAC data request packets and CMS data use agreements; 2) expertise in Medicare data analysis, cancer registry data, atlas design and spatial statistics; and 3) working with CDC, state CCC programs, state cancer registries, or other similar organizations on collaborative data analysis research.

If the contractor plans to staff the Project Leader or Task Manager positions with new hires, letters of intent from new employees should be included. In addition, contractors are encouraged to retain outside consultants with special expertise relevant to this task order. If the contractor plans to exercise this option, letters of intent from outside investigators should also be included. The CVs of all key personnel who will be affiliated with this task order should be provided in the appendices. The proposal should also describe the project’s organization including an organizational chart of staff assigned to the project. In addition, the proposal should also describe relationships and partnerships with other organizations which are relevant to this task.

This criterion will be evaluated according to the soundness, practicality, and feasibility of the offeror’s staffing and management plans for this task order.

B. Technical Approach

Contractors are expected to demonstrate an understanding of the study goals and steps necessary to develop the CDC IRB protocol, the ResDAC data request packet, and the CMS data use agreement. . The Contractors are to provide a discussion of their technical approach to providing the services required for this task order including, but not limited to: 1) an approach to identifying and soliciting the cooperation of a state central cancer registry in one or more states, 2) the methods for developing a draft CDC IRB protocol, ResDAC data request packet, and CMS data use agreement; and 3) the methods to identify a panel of 3 external reviewers to review the draft protocol, data request packets, and data use agreements. The proposal should specify how all tasks in the Description of Work will be accomplished. The contractor is to provide a detailed time line for accomplishment of these tasks.

This criterion will be evaluated according to the soundness, practicality, and feasibility of the contractor’s technical approach for providing the services required for this task order.

C. Similar or Previous Experience

The contractor should provide information reflecting experience that is similar in complexity and size to the anticipated project. The contractor must document that they have previously conducted Medicare data analyses, and have conducted research similar to, or relevant to, the study questions outlined in the RFTP.

TECHNICAL MONITOR: To be determined

PROJECT OFFICER: Christine Dauer Public Health Advisor Division of Cancer Prevention and Control (DCPC)

National Center for Chronic Disease Prevention and Health Promotion

4770 Buford Highway NE, MS K-55 Atlanta, Georgia 30341-3724 Telephone: 770-488-3056

COST EVALUATION

The contractor’s cost proposal shall be reviewed for reasonableness for the work requirements contained in the RFTP. Should negotiation become necessary, the contractor will be notified of specific items within its proposal found to be unreasonable or otherwise deficient as to price.

J. INSTRUCTIONS TO CONTRACTORS

As a contract holder of CDC/NCCD/DCPC Multiple Award Contracts, this is considered your fair opportunity for consideration of the RFTP in accordance with FAR 16.505(b)(1) and Section H of the basic contract.

The following pre-award Federal Acquisition Regulation (FAR) provisions apply to this request for task order proposal, and are hereby incorporated by reference:

Number Date Title 52.215-1 JAN 2004 Instructions to Offerors--Competitive Acquisition

Your response must be submitted in two parts: a Technical, and a Business proposal. Each part shall be separate and complete in itself so evaluation of one may be accomplished independently of the other.

Required Statements: Your proposal should indicate that the proposal is predicated on the terms and conditions of the NCCD Contract No. ______________; is valid for a period of 60 days; and a brief statement indicating current or future commitments during the proposed performance period and what impact the commitments might have on performance if awarded.

Proposals are not to include any additional information regarding past performance, letters of reference, or corporate capability. This information was submitted previously when the contracts were awarded. The proposal is to reference only the proposed work and budget for the referenced RFTP. Proposals containing information that is not specific to the proposed task will not be evaluated.

Awardees are not required to submit a proposal in response to this request for task proposal.

The Government shall not pay any cost for the preparation and submission of proposals submitted in response to this RFTP. All communications concerning this project prior to the award of a task order under this RFTP shall be with the Contracting Officer or his/her designee. Communications with unauthorized individuals concerning a specific RFTP prior to award may jeopardize your eligibility for award.

K. REFERENCES

1. Center for Clinical Evaluative Services, Dartmouth Medical School. The Care of Patients with Severe Chronic Illness: An Online Report on the Medicare Program.

Lebanon, NH: Center for the Evaluative Clinical Sciences, Dartmouth Medical School.

2006. http://www.dartmouthatlas.org/atlases/atlas_series.shtm

2. Iowa Foundation for Medical Care. Chronic Condition Data Warehouse. User Manual.

Version 2.0. January 2007. Available at:

http://www.resdac.umn.edu/CCW/data_available.asp

3. Cooper GS, Virnig B, Klabunde CN, Schussler N, Freeman J, Warren JL. Use of SEER-Medicare data for measuring cancer surgery. Med Care. 2002 Aug;40(8 Suppl):IV-43-8.

4. Virnig BA, Warren JL, Cooper GS, Klabunde CN, Schussler N, Freeman J. Studying radiation therapy using SEER-Medicare-linked data. Med Care. 2002 Aug;40(8 Suppl):IV-49-54.

5. Warren JL, Harlan LC, Fahey A, Virnig BA, Freeman JL, Klabunde CN, Cooper GS, Knopf KB. Utility of the SEER-Medicare data to identify chemotherapy use. Med Care.

2002 Aug;40(8 Suppl):IV-55-61.

6. Potosky AL, Warren JL, Riedel ER, Klabunde CN, Earle CC, Begg CB. Measuring complications of cancer treatment using the SEER-Medicare data. Med Care. 2002 Aug;40(8 Suppl):IV-62-8.

ATTACHMENT

Appendix 1. Outline for a CDC Institutional Review Board Protocol.

A. Project Overview

1. Title:

2. Protocol Summary

3. Investigators/collaborators/funding sources

B. Introduction

1. Literature Review/Current State of Knowledge about Project Topic

2. Justification for Study

3. Intended/Potential Use of Study Findings

4. Study Design/Locations

5. Objectives

6. Hypotheses or Study Questions

7. General Approach

C. Procedures and Methods: Design

1. How study design or surveillance system addresses hypotheses and meets objectives

2. Audience and stakeholder participation

3. Cost benefit/prevention effectiveness

4. Study time line

5. Expedited protocol review request

D. Procedures and Methods: Study Population

1. Description of the study population and catchment area

2. Case definitions

3. Participant inclusion criteria

4. Participant exclusion criteria

5. Justification of exclusion of any sub-segment of the population

6. Estimated number of participants

7. Sampling, including sample size and statistical power

8. Enrollment

E. Procedures/Methods: Variables/Interventions

1. Variables

2. Study instruments, including questionnaires, laboratory measurements, and analytic tests

3. FDA Investigative New Devices (IND) information:.

4. Intervention or treatment

5. Outcomes and meaningful differences

6. Training for all personnel

F. Procedures/Methods: Data Handling and Analysis

1. Data analysis plan, including statistical methodology and planned tables and figures

2. Data collection

3. Information management and analysis software

4. Data entry, editing, and management, including handling data collection forms, different versions of data, and data storage and disposition

5. Quality control/assurance

6. Handling results in the absence of a reference test

7. Measurement/estimation and adjustment for cross reactivity

8. Verifying independence of tests used to confirm results of new test being studied

9. Bias in data collection, measurement and analysis

10. Intermediate reviews and analyses

11. Limitations of study

G. Procedures/Methods: Handling of Unexpected Adverse Results

1. Response to new or unexpected findings and to changes in the study environment

2. Identifying, managing, and reporting adverse events

3. Emergency care

H. Procedures/Methods: Dissemination, Notification and Reporting of Results

1. Notifying participants of their individual results

2. Notifying participants of study findings

3. Anticipated Products or Interventions Resulting from the Study and Their Use

4. Disseminating Results to the Public

H. References

J. Appendix Materials

1. Data Collection Forms

2. Proposed Tables or Figures

3. Other Relevant Documents

A. Justification for waiver of the requirement to obtain informed consent.

B. Justification or expedited review procedures

Department of Health and Human Services