Attachment_J.2-Sample_Task_Order-SOW_ _SOD.pdf

Attachment J.2 – Sample Task Order & Schedule of Deliverables

RFP-CMS-RMADA-2014

Functional Improvement to Reduce Healthcare Costs (FIRHC) Demonstration

I. Introduction

The Demonstration is being conducted under the authority of § 3021 of the Patient Protection and Affordable Care Act and is based on the Community Living Assistance Services and Supports Act (CLASS Act). Signed into law in March, 2010, part of the Patient Protection and Affordable Care Act established The CLASS Act, a national voluntary insurance program for purchasing community living assistance services and support1.

The purpose of the CLASS Act was to:

‘‘(1) provide individuals with functional limitations with tools that will allow them to maintain their personal and financial independence and live in the community through a new financing strategy for community living assistance services and supports;

‘‘(2) Establish an infrastructure that will help address the Nation’s community living assistance services and supports needs;

‘‘(3) alleviate burdens on family caregivers; and

‘‘(4) address institutional bias by providing a financing mechanism that supports personal choice and independence to live in the community.” (42 USC 300ll).

On October 14, 2011, U.S. Department of Health and Human Services Secretary Sebelius transmitted a report and letter to Congress stating that the Department did not see a viable path forward for CLASS implementation at this time2.

The CLASS Act was repealed as part of The American Taxpayer Relief Act of 20123 which was signed into law on January 1, 2013. The structure of this demonstration is based on the original text, as written and as explained/defined in detail below.

As a joint project between Medicare and the Social Security Administration, the Demonstration will use the Social Security Administrations definition of disability.

Section 223(d) (1) of the Social Security Act defines disability as an—

“(1) inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than 12 months, or

“(2) in the case of an individual who has attained the age of 55 and is blind (within the meaning of blindness as defined in section 216(i) (1)), inability by reason of such blindness to engage in substantial gainful activity requiring skills or abilities comparable to those of any gainful activity in which the individual has previously engaged with some regularity and over a substantial period of time.

In most cases, a dollar amount is used to indicate whether a person is engaging in substantial gainful activity (SGA). For 2011, the SGA amount was $1,000 per month for a nonblind individual and $1,640 per month for a blind person. Effective January 2001, the SGA level is adjusted annually on the basis of the national average wage index4.

II. Purpose / Background

Under this Demonstration, the Centers for Medicare & Medicaid (CMS) will join with the Social Security Administration (SSA) to design, implement, and evaluate the Functional Improvement to Reduce Healthcare Costs (FIRHC) Demonstration. The FIRHC Demonstration is a five-year demonstration that will assess the impact of FIRHC in providing comprehensive, coordinated, continuous, and accessible care to improve physical functional performance for Medicaid beneficiaries aged 18 to 64 years that have applied for Social Security Disability Insurance (SSDI) and are currently in the 24-month waiting period for Medicare eligibility. During this waiting period, programs intended to provide personal assistance to promote independence and/or re-employment have the potential to improve health outcomes, promote re-employment, and reduce the number of individuals who become Medicare eligible due to disability status. In 2010, 42% of Medicare/Medicaid beneficiaries were also workers with a disability (aged 21 – 64 years).5

The goals of the demonstration include:

• Reduction in the numbers of Medicaid beneficiaries with a disability simultaneously eligible for Medicare benefits;

• Improvement of health outcomes commensurate with the beneficiaries’ stage of chronic illness;

• Improved employment rate of Medicaid beneficiaries with a disability;

• Reduction of the cost of healthcare services;

• Reduction in the number of SSDI beneficiaries;

• Achievement of enrollee, family caregiver, and provider satisfaction with coordinated care;

Background

Working age Medicaid beneficiaries with a disability, aged 18 – 64 years, (hereafter referred to as workers with a disability) are an important target population for comprehensive, coordinated care due to their potential simultaneous eligibility for three federal benefits programs – Social Security Disability Insurance (SSDI), Medicaid and Medicare. In 2010, 64.9% of SSDI enrollees, aged 21 – 44 years, were also Medicaid/Medicare beneficiaries (50% of SSDI enrollees, aged 45-54 years; 31.4% of SSDI enrollees, aged 55-64 years)5.

Federal spending on workers with a disability was estimated at $357 billion in 2008; state expenditures (90% for Medicaid) were estimated at $71 billion4. SSDI benefits for workers with a disability and their dependents totaled $101.7 billion with an additional $26.2 billion paid out in Supplemental Security Income4.

Incidence rates of individuals with a disability applying for benefits tend to increase temporarily during bad economic times. The recent recession of 2008-2009 resulted in an increase in disability incidence not seen since 1975. For example, by the end of 2001, SSA paid disability benefits to 5.3 million individuals, and granted disability status to an average of 57,600 people per month6. By December, 2007, SSA paid out disability benefits to 7.1 million workers and averaged 68,900 new disability benefit awards per month. By July, 2012, 8.8 million workers were collecting disability benefits, with an average of 82, 400 new beneficiary awards made each month6.

Typically, a worker with a disability applying for SSDI faces a five step requirement process to prove disability, with denial of benefits possible at any step: 1) verification of applicant’s disability; 2) filing a claim; 3) recent work and duration of work test; 4) verification that individual is not at normal retirement age; and 5) a five month waiting period from disability-onset7. Upon successful completion of the five step requirement process, receiving SSDI entitlement, and after a 24 month waiting period from onset of disability (as defined in Step 1 of the SSDI requirement process), the worker with a disability is approved for Medicare (persons with end stage renal disease or amyotrophic lateral sclerosis do not have this waiting period) (See Figure 1). The receipt of Medicare eligibility is automatic at the end of the 24-month waiting period following SSDI entitlement. However, the SSDI application process can take longer than 24 months if there is a denial of benefits and subsequent appeal.

Figure 1. Timeline of Relationships Between Disability Onset, SSDI Application Process, and Medicare Eligibility

Following enrollment in SSDI, the worker with a disability becomes eligible for federal and state programs for vocational rehabilitation and employment assistance. Four primary programs are available: (1) Work Incentive Planning and Assistance Program (WIPA); (2) Protection and Advocacy for Beneficiaries of Social Security (PABSS) program; (3) Ticket to Work program; and (4) Social Security/Vocational Rehabilitation program. WIPA and PABSS assist the beneficiary in understanding the benefits programs and making informed decisions. Ticket to Work programs and Social Security/Vocational Rehabilitation programs are designed to increase access to employment services8. Overall, benefits counseling has a positive relationship with future employment9.

However, the typical SSDI recipient stays in the SSDI program for many years. The three main routes to leaving the program are: death, reaching full retirement age when beneficiary status shifts to retirement Social Security and Medicare, and loss of eligibility due to no longer meeting medical disability standards. In 2004, only 12% of beneficiaries exited for these reasons10. In a 10-year follow-up study of SSDI beneficiaries, 3.7% of the beneficiaries had their benefits terminated after finding work11. In the same study, Liu and colleagues reported that most SSDI beneficiaries who found work and used work incentives do so in the first five years on the SSDI rolls.

Further, although approximately a third of all SSDI beneficiaries have mental disorders as the primary diagnosis for disability status, the primary diagnosis for SSDI awards for all workers with a disability aged 18 – 64 years in 2011 was musculoskeletal disease (typically back pain or arthritis)12. Some individuals who qualify for SSDI based on the severity of their impairment may be able to work given the opportunity and needed assistance13.

Prior multi-modal interventions for health promotion have reported some success in improving health and employment outcomes14,15. However, an examination of the potentially highest cost beneficiaries has not been undertaken. Three factors combine to create a window of opportunity for a healthcare system intervention: 1) a physical health problem as the primary reason for an SSDI application for a working age adult with a disability; 2) some evidence that employment intervention in the first 5 years after enrollment in SSDI may lead to termination from SSDI rolls; and 3) a 24 month waiting period for a Medicaid beneficiary waiting for Medicare approval. Improving the physical functional status of the beneficiary may result in the beneficiary exiting the rolls of SSDI, thereby no longer being eligible for Medicare. Given that an average SSDI beneficiary accumulates lifetime benefits of approximately $240,00010 plus additional Medicare/Medicaid benefits, the cost savings to CMS could be substantial by facilitating exit from the SSDI rolls and preventing entry onto the Medicare rolls.

III. Research Questions and Design

The FIRHC Demonstration and Evaluation is a 5-year Demonstration and Evaluation, under which eligible sites will propose their own evidence-based design to receive reimbursement for conducting a clinical trial. The proposed clinical trial will be designed to assess the feasibility and effectiveness of providing comprehensive, coordinated, continuous, and accessible care to improve physical functional performance to Medicaid beneficiaries aged 18 to 64 years with a physical disability. The targeted Medicaid beneficiaries will have applied for Social Security Disability Insurance (SSDI) and will currently be in the initial 2 months of the 24-month waiting period for Medicare eligibility. Ten eligible sites will be selected. Each site will conduct self-monitoring activity; however, CMS will conduct an independent evaluation of the FIRHC Demonstration. The Contractor will assist CMS with the planning, design, development, implementation and evaluation of the chosen demonstration sites. The Contractor will be aware of the following areas of concern to CMS.

Rapid-cycle Nature of the Evaluation. The evaluation approach for this Demonstration must be sensitive to the continual need for rapid-cycle and close to real time production of findings. Findings must be available to CMS and the awardees throughout the life of the project, not just in annual reports. Specifically, CMS will expect to receive timely information on the findings that can be used by CMS staff to make decisions about programmatic changes. This last activity will happen during the course of the evaluation in a rapid-cycle manner rather than waiting to the end of the evaluation. Consequently, awardees may modify their interventions as part of their continuous quality improvement activities.

Therefore, the rapid-cycle evaluation plan must be designed in a way to adjust to the potential modifications and to evaluate programs integrating quality improvement activities.

Analysis by Type of Intervention or Other Relevant Category. To the extent possible, the evaluation approach should examine each awardee individually to answer all applicable research questions. In some cases, however, we anticipate the need for or benefit of grouping similar awardees together to improve the generalizability and statistical precision of results, as well as benefit from economies of scale.

Medicaid Beneficiaries. Offerors should be cognizant of the challenges in evaluating the effects of programs on this population, including, but not limited to: obtaining data, churning in eligibility, and literacy and language barriers.

Role of Qualitative and Quantitative Methods. The qualitative assessment of the FIRHC is a critical aspect of this evaluation. The qualitative analyses should be viewed as the context within which the quantitative analyses are described. That is, the qualitative and quantitative analyses should not be approached as distinct and separate activities. One should inform the other in a very explicit and deliberate manner. Further, qualitative methods will be important, given the potential for small samples in some of the subpopulations of selected programs.

Interest in Specific Beneficiary Subpopulations. CMS is also interested in learning how the model affects subpopulations of Medicaid beneficiaries (e.g., complex patients) who have unique characteristics or different health care needs that could result in different impacts. When appropriate and practical, the Contractor’s plans for primary data collection should identify samples or key populations on which primary data will be collected.

Awardee Burden and Coordination of Activities. The Contractor must be cognizant of the burden imposed upon awardees. To the extent possible, awardee and participant burdens should be minimized. In addition, the Contractor will be expected to coordinate with CMS in order to most efficiently utilize the awardees’ time and effort.

The Contractor will assist CMS project officers in overseeing the awardees. The Contractor will collect quarterly data from awardees and create reports for CMS. In addition, the Contractor will assist in identifying and trouble-shooting problem areas in the execution of the awardees’ work plans. Additionally, the Contractor will provide a systematic, data-driven, shared learning infrastructure for this model test and its’ participating sites in order to accelerate progress towards accomplishment of the model’s aims. Evaluation activities appropriate to the awardee’s interventions will be required as will a meta-analysis of the effect of the programs on SSDI and Medicare costs.

Overall, six main components are identified:

Component 1: Demonstration Design and Development Activities to be Implemented Prior to CMS Selection of Sites

a. Demonstration Planning and Pre-Development – these activities establish the foundation of a demonstration by obtaining information necessary to conceptualize or plan the proposed demonstration. These activities may include literature reviews, the development of issue/concept papers, driver diagrams including aims and primary/secondary drivers, preliminary site selection criteria, primary data collection activities of limited scope, micro simulations (if needed), issues with insurance transitions and potential eligibility problems, secondary data analysis and computer programming tasks to prepare data for analysis.

b. Project Design – these activities involve preparing specific project design and evaluation protocols. Specific examples are:

• Preparation of a Project Design – Based on a general project design described in the task order, the contractor will prepare a specific design. Work associated within this activity (or any other activity) which the Contractor has performed as a part of the contractor’s proposal for contract approval, is not directly reimbursable under this TOC. The design must be sufficiently detailed to comprehensively describe how the Demonstration will be designed and implemented.

• Development of Project Implementation Plans – After finalizing the project design, the Contractor will prepare a plan specifying the steps to be taken to implement the demonstration and evaluation including the learning system. The plan would include:

Proposed criteria for CMS selection of demonstration sites along with recruitment and, potentially, incentives needed to encourage sites to apply.

Schedules for site selection, development, client recruitment, caseload build-up, full operations, and wind-down activities.

Procedures for training data collectors, intake workers, or other staff.

Proposed shared learning infrastructure, including collaborative adult learning-based activities, potential topics, and logistics.

Methods for capture of changes tested, implemented and spread throughout their organization.

Balanced measurement plan for participant site and model test improvement.

Component 2: Recruitment of Demonstration Sites

The second component of this research project will consist of recruiting and partnering with Demonstration Sites. CMS anticipates that Demonstration Sites will be non-profit organizations, academic institutions, and/or state-level agencies. The first task of the Contractor will be the design and implementation of an application and subcontract award process where applicants can apply for funding and support for their health care demonstration. The application and selection process should be fair and transparent, allowing programs to present their best case for inclusion and having a systematic evaluation methodology in place to evaluate the applicants and make selection determinations. The Contractor should be prepared with:

site solicitation notices, application instructions and site selection criteria;

to conduct site visits to determine the extent to which these potential sites satisfy the selection criteria;

to notify selected sites, and furnish them information needed to start the demonstration.

CMS has the goal of partnering with ten applicants. All of the work on the first component of this research should be completed within the first project year.

Component 3: Demonstration Implementation and Monitoring Activities

a. Implementation Activities - These involve the development, preparation and implementation of the plans and strategies necessary to operate the Demonstration project. Included, among others, are: defining potential training needs; working meetings and site conferences; shared learning infrastructure, methods for capture of changes tested, implemented and spread throughout their organization, balanced measurement plan for participant site and model test improvement and obtaining necessary pre-clearances for project implementation, data collection, and data analysis activities. It is anticipated that all selected Demonstration Sites will begin their interventions in Year Two of the project, within 6 – 12 months of selection.

b. Monitoring Activities – These activities assist CMS in providing ongoing oversight and support of the Demonstration. Examples of such activities include; providing technical assistance and consultation to participating providers and sites; collecting and analyzing data from demonstration sites or participants; preparing status reports; monitoring the quality of services furnished by participating providers; conducting site visits, and calculating payment rate adjustments in accordance with the specific project design.

Component 4: Demonstration Evaluation Activities

The fourth component of this research work will consist of ongoing evaluation of the impact of the demonstration. Evaluation activities usually include among other activities, the development of a detailed evaluation design, actual data collection, and quantitative and qualitative analyses to answer the research questions that are the focus of the demonstration. It is anticipated that these evaluation activities may on occasion include the development of Public Use Data Files with accompanying data dictionary from the demonstration/evaluation data. The Public Use Data Files will adhere to CMS guidelines for confidentiality of personally identifiable information. Following development of a data evaluation plan, five domains of evaluation are envisioned: Self-monitoring, Shared Learning and Quality/Process Improvement, Population-based Survey, Claims Based Evaluation and Meta-analysis.

a. Development of a Data Evaluation Plan

Following approval of the project’s design, the Contractor would prepare and submit a draft data collection plan to the COR for review and approval. After receipt of comments, the contractor would be required to make revisions and submit a final data collection plan to the COR for review and approval. The data collection plan shall specify in detail what data collection activities will be undertaken and respective sources of data with plans for data access with respect to the collection of both primary and secondary data.

For each primary data collection activity, at a minimum, the plan should contain: (a) the purpose of the data collection with respect to the hypotheses to be tested; (b) the source of the data and the techniques to be used to collect or otherwise acquire the data; (c) the data elements to be collected and draft data collection instruments; (d) discussion of the sample size, sampling techniques and how they were determined; (e) quality techniques to be employed; (f) plans to produce training materials for data collectors; (g) plans to obtain and train interviewers or data collectors; (h) computer record formats; and (i) detailed time tables and budget estimates that supplement the design plan.

For each secondary data collection activity, at a minimum, the plan should contain (a) the data source; (b) the content of the data files; (c) the quality of the data; (d) the reliability of the data sources for providing the data; (e) the time schedule for obtaining the data taking into account anticipated data lag; and (f) the cost of obtaining the data.

The Contractor will also be required to prepare any required Office of Management and Budget reports clearance packages for the implementation of the data collection plan.

b. Domain 1: Self-Monitoring Selected applicants will be responsible for monitoring, evaluating and reporting on the progress and impact of their program. Self-monitoring involves maintaining performance assessment or quality improvement metrics that demonstrate progress towards achieving the goals of this Demonstration, such as functional improvement in the target population and exit from the SSDI rolls. The Contractor will support the selected applicant in incorporating standardized measures from the CMS Standardized Measures List in the self-monitoring plan. The Contractor will assist CMS project officers in overseeing the applicants. The Contractor will collect quarterly data from applicants, focused on process measures, progress towards implementation of the applicants’ work plan and outcome measures. This data will be used to prepare CMS reports. In addition, the Contractor will assist in identifying and trouble-shooting problem areas in the execution of the applicants’ work plans. It is anticipated that this will occur during Years 2 and 3 of the Demonstration.

Specific Research Questions to be addressed under Domain 1:

RQ 1. Did enrollee participation in a vocational rehabilitation and/or employment service program lead to improvement in key functional health measures?

RQ 2. Did enrollee characteristics influence these functional improvements?

RQ 3. Did enrollee participation in a vocational rehabilitation and/or employment service program lead to improvements in self-reported health status and other key health outcome measures?

RQ 4. Did enrollee participation improve health related quality of life?

RQ 5. Did any enrollee characteristics influence or modify improvements in health outcomes?

RQ 6. Did Demonstration participation improve enrollee life satisfaction?

RQ 7. Did Demonstration participation improve family caregiver life satisfaction?

RQ 8. Did Demonstration participation improve provider role satisfaction?

RQ 9. Did enrollee participation improve participant well-being?

RQ 10. What was the impact of coordination of care of functional improvement?

RQ 11. Did enrollee participation in a vocational rehabilitation and/or employment service program lead to full employment?

RQ 12. Did enrollee participation in a vocational rehabilitation and/or employment service program lead to partial employment?

RQ 13. Did enrollee participation in a vocational rehabilitation and/or employment service program lead to assumption of meaningful life activities as defined by participant?

c. Domain 2: Shared Learning and Quality/Process Improvement

The Contractor will provide a systematic, data-driven, shared learning infrastructure for this model test and its’ participating sites in order to accelerate progress towards accomplishment of the model’s aims. CMS plans for cohorts of affinity sites with similar objectives to collaborate in discussing changes that are working and common problems of implementation and will collaborate with experts to offer solutions to these problems.

Evaluation of the impact of this shared learning system will be an essential component of the process evaluation. It is anticipated that this will occur throughout the Demonstration to keep pace with the ongoing learning infrastructure

A qualitative description of the various programs’ operations and costs with an eye toward determining what best practices are and how the aims and drivers are being accomplished (and how to better package and spread the various programs and interventions will be required. In order to determine the key interventions or changes that are resulting in success (mapped to the aims/drivers) , the Contractor shall, at a minimum, capture key qualitative and quantitative ideas/changes/interventions/data during all shared learning activities, interview key personnel involved with administering the programs and observe trainings, intervention sessions where possible, and other relevant activities.

A critical aspect of this component is costing out the various labor and technical inputs required to implement and operate each of the programs’ operations and interventions, both to provide a basis for estimating the cost-benefit/effectiveness of the various prevention activities and to provide a roadmap to others seeking to implement similar programs. Most of the work on this component is expected to occur in the third and fourth project years.

Specific Research Questions to be addressed under Domain 2:

RQ 14. What is the impact of collaborative learning on the objectives of functional health?

RQ 15. What are the best practices for program implementation and operations and what lessons can be learned from the various programs?

RQ 16. What strategies were identified that helped achieve the goals of the demonstration?

RQ 17. Did the various interventions delivered by the vocational rehabilitation and/or employment service programs studied maintain a high level of fidelity to their respective evidence bases?

d. Domain 3: Populations-Based Survey

The Contractor will develop a population-based survey evaluation of program impacts on functional outcomes and self-reported health behaviors. The goal of this analysis is to identify and test for improvements over baseline values in relevant self-reported outcomes immediate post-intervention and 6-months post-program participation.

Inherent in this process will be the need to identify a comparison group. Examples of potential outcomes could include functional health measures, self-reported health status and experience of care, measures of health related quality of life, health behaviors, return to work, and out of pocket health care spending. Work on this domain of the research project will span all 5 project years.

Specific Research Questions to be addressed under Domain 3:

RQ 18. What percentage of working age Medicaid beneficiaries with a disability that applied for SSDI benefits enrolled in Medicare at the end of the 24-month waiting period?

RQ 19. Were any beneficiary characteristics associated with enrollment in Medicare at the end of the 24-month waiting period?

RQ 20. Were any beneficiary characteristics associated with not enrolling in Medicare at the end of the 24-month waiting period?

RQ 21. Did beneficiary participation in a vocational rehabilitation and/or employment service program lead to reductions in health service utilization (including but not limited to: ER visits, hospitalizations, preventable hospitalizations, SNF stays, outpatient visits, etc.) and associated costs?

RQ 22. Did beneficiary participation in a vocational rehabilitation and/or employment service program lead to reductions in use of durable medical equipment?

RQ 23. Were any beneficiary characteristics associated with the improvements in cost and utilization outcomes identified in RQ21?

RQ 24. Did beneficiary participation in a vocational rehabilitation and/or employment service program lead to reductions in beneficiary out of pocket costs?

RQ 25. Did any beneficiary characteristics influence out of pocket cost savings?

e. Domain 4: Claims Based Evaluation of Program Impacts

The fourth domain of this research project will consist of a claims based evaluation of program impacts on SSDI and Medicare utilization and cost outcomes. The claims-based analyses should identify the number of SSDI enrollees that, upon becoming eligible for Medicare, accept Medicare enrollment and the first year of beneficiary participation utilization and cost outcomes. These analyses should primarily focus on claims based measures of service and medication utilization that are key drivers of costs and health outcomes under the Medicare program. This will involve developing a total cost of care measure addressing such issues as claims lag time and intervention fees. The previously identified comparison group should be integrated into these analyses to serve as comparators to the actual program participants. Work on this component of the research project will also span all 5 project years.

Specific Research Questions to be addressed under Domain 4:

RQ 26. What were the average per beneficiary/participant operational cost of the various programs and associated interventions?

RQ 27. Did intervention fidelity impact beneficiary health, utilization, and cost outcomes?

RQ 28. Did the potential cost savings arising from program participation exceed the costs of delivering the intervention to beneficiaries?

RQ 29. Is the cost of one year of comprehensive, coordinated, personal care paid for by

CMS offset by the savings in the number of people who do not come onto Medicare rolls?

f. Domain 5: Global Assessment

The final evaluation domain will be a global assessment of the ten demonstrations. This assessment will examine the feasibility, efficacy and effectiveness of a functional intervention for workers with disability during the 24-month waiting period for Medicare eligibility from the perspective of all of the Demonstration projects. This global assessment will involve an examination of changes in health, health care, and costs to SSDI, Medicare and Medicaid in the 12 months prior to SSDI enrollment through the 6 months post-Medicare enrollment. A population comparator group will be needed to understand the changes from the Demonstrations. This domain will be primarily worked on during Years 4 and 5 of the project years.

Specific Research Questions to be addressed under Domain 5:

RQ 30. What business case can be made for additional program dissemination and/or scalability?

RQ 31. Among all the programs and interventions that will be studied, which appear to be the most cost effective, both in terms of generating savings and in terms of improving health outcomes?

RQ 32. Did programs appear to be more or less effective in different beneficiary sub-groups?

In addition to these research questions, the Contractor should feel free to propose additional areas of inquiry to CMS that may be of value to the government.

In evaluating the key research questions posited under this research project, the Contractor shall use methods and study designs that are consistent with best practices in health services research, with particular attention to constructing appropriate comparison groups for the various programs, interventions, and analyses and appropriately accounting for potential confounders in describing program impacts.

Figure 2 depicts the broad analytic framework for this research project. As illustrated in the diagram, the key to success for this research effort is integrating the various components of this study to answer the various research questions that are of interest to CMS and SSA.

Figure 2: Analytic Framework

Data Sources

Data for the FIRHC will be available from several sources. Primary data will be collected by the Contractor by the survey of the program participants and the general beneficiary population. Secondary data analysis will be available from Medicare Part A and B claims files, Part D Prescription Drug Event Files, and other CMS administrative data. Social Security Administration data may be available from the Disability Analysis File. A separate Data Use Agreement will be needed for access to the Social Security Administration data.

After the completion of the appropriate data use agreements and business associates agreements, data from the programs will be available to the Contractor for analysis of the effects of the programs. In analyzing these data, the Contractor will be required to adhere to the data security and confidentiality requirements in CMS’s data use agreement.

Component 1: Demonstration Design & Development

Component 4:

Demonstration

Evaluation

Domain 2:

Shared Learning System

RQ 14-17

Component 5:

Scale and Close Out

Domain 1:

Self-Monitoring

RQ 1 - 13

Domain 3:

Populations-Based Survey

RQ 18-25

Domain 5:

Global Assessment

RQ 30-32

Domain 4:

Claims Based Program Impacts

RQ 26-29

Component 2: Recruitment of Program Sites

Component 3: Demonstration Implementation & Monitoring

Com ponent 6: Preparation of Reports

A copy of CMS’s Data Use Agreement can be found here:

http://www.cms.gov/cmsforms/downloads/cms-r-0235.pdf

More information on CMS data sources and procedures for obtaining data can be found on RESDAC’s website: http://www.resdac.org/Index.asp

Offerors should prepare to obtain these data independently either through RESDAC/Buccaneer or via direct access into CMS’s data system as CMMI has limited access to the programming support required to create custom datasets for Contractors.

Component 5. Scale and Close Out

Preparation of the Demonstration Phase-out Plan – The Contractor would prepare a phase-down/phase-out plan that (a) ensures that beneficiaries or other Demonstration participants are phased-out of any special programs which were initiated or existed as reimbursable or covered services only under the auspices of the demonstration project and, in so doing, ensures that alternative care plans are in effect for the project participants by the scheduled completion date of the project; (b) ensures that enrollment of new participants will be discontinued in time for an orderly phase-out; and (c) ensures that any new payment methods initiated by the project will cease to apply by the scheduled end of the project.

Component 6: Preparation of Reports

Under the task order, the Contractor will be required to prepare and submit a series of summary reports for the COR’s review and approval. Each report shall include a 1 to 5 page executive summary unless otherwise specified. The reports may include: (a) annual statistical summaries of the impact of the project on the cost, utilization, of services and other program outcomes and financial effects, or the findings of the project;

(b) a statistical summary of any survey data; (c) preliminary statistical summaries of the impact of the project on total health care utilization, costs and other outcomes or findings; and (d) qualitative summaries of the impact of the project.

Each report contains a discussion of: the research issues addressed in the report; the methods of data collection; the limitation in the data and the findings; and outcomes analysis. Upon receipt of comments from CMS regarding each report, the Contractor shall make revisions and submit a final version of each report to the COR for review and approval. If the Contractor does not agree with CMS, then the Contractor shall raise the issue with the COR and if a satisfactory conclusion cannot be reached the issues shall be raised to the Contracting Officer.

IV. Specific Tasks Under the Contract

The Contractor shall provide the necessary personnel, materials, equipment, support and supplies (unless government supplies, data or equipment are indicated) to accomplish the functions described below. The Contractor will be required to complete the analyses and report to CMS on the findings. All work done under this task order shall be performed under http://www.cms.gov/cmsforms/downloads/cms-r-0235.pdf http://www.resdac.org/Index.asp the general guidance of the CMS Contracting Officer Representative, the SSA COR and is subject to CMS and SSA approval.

The results of this evaluation may be used to inform programmatic policy decisions.

Therefore, the Contractor shall not release any data or information from this Task Order before policy decisions are finalized, unless the Contracting Officer agrees to an early release.

All of the work that will be performed under this effort is divided into a base year and four optional project years. Award of the individual project year options will be contingent on successful progress on the project.

Task 1: Project Management and Quality Control

Task Overview:

The success of the project will require effective ongoing project management. In order to ensure that this Demonstration and research effort is successfully progressing, the Contractor will need to develop key project management materials and maintain regular contact with the CMS COR and the SSA COR; submitting timely progress reports, managing and maintaining data use agreements (DUAs), and making necessary adjustments to the Project Work Plan and Project Analysis Plan on an as needed basis in consultation with the CMS COR and the SSA COR.

The Contractor shall coordinate all activities necessary to complete the project in accordance with the Schedule of Deliverables. Offerors should propose how they plan to regularly inform the CORs of their progress, discuss administrative and project issues as they arise, and report preliminary findings of analyses as they become available. This might include such things as conference calls with written agenda and written summary and/or monthly progress reports, which would outline all work accomplished in the previous month, describe activities planned for the coming month, alert the CORS to any potential issues, etc.

Specific Subtasks:

Task 1.1: Project Kickoff Meeting

Within 15 business days of contract award, the contractor shall conduct a kickoff meeting with CMS. The meeting shall initiate the communication process between all parties and shall be either by videoconferencing or held at CMS’s offices in Baltimore, MD. The Kick-off Meeting is the first meeting with the project team members to discuss the project and the work that will be completed.

This meeting introduces the members of the project team and provides the opportunity to discuss the role of each team member in the project work. The other base elements in the project may also be discussed at this meeting (Project Task List, Deliverables, Schedule, Lines of Communication, etc.). The Contractor shall meet periodically with the CORs and with CMS and SSA staff to discuss the details of the design of the evaluation and findings to date.

For all meetings, the Contractor shall submit draft briefing materials, including presentation slides, to the CORs two weeks prior to the meeting. Final briefing materials shall be submitted to the CORs one week prior to the meeting and shall address comments received by the CORs. The Contractor shall be responsible for bringing hard copies of all meeting materials for distribution to CMS and SSA staff.

12, 24, 36 and 48 months after award, the Contractor shall attend a meeting with the CMS and SSA CORs and other CMS and SSA staff at CMS in Baltimore, MD or plan a videoconference to review progress on the project, to present interim findings, and to discuss other ongoing analyses, planned activities, and technical issues.

Task 1.2: Finalized Implementation Plan

The contractor shall refine and update the study design described in the technical proposal, addressing any initial comments or questions arising from CMS’s review of the technical proposal, participant feedback from the kick-off meeting described in Task 1.1.a, and CMS review of subsequent drafts of the study design to create a Final Implementation Plan. The Final Implementation Plan is a formal project deliverable that shall be due within 10 business days of the Project Kickoff Meeting. In finalizing this deliverable, the contractor should build in adequate time for receiving and incorporating comments from CMS.

Task 1.3: Finalized Evaluation Design Plan

The evaluation design plan will take into account the goals of the independent evaluation.

At a minimum the plan shall address the following items:

• A description of the evaluation approach.

• A discussion of specific analytic approaches including optional strategies as may merit consideration.

• A listing of any additional types of data to be collected for the independent evaluation and the planned approach for the information collection (for example: site-reporting, on-site visits, telephone interviews, focus groups, survey).

• A discussion of the use of SSA and CMS administrative and claims data.

• A discussion of how and if individual site data might be combined or pooled for analysis, and a consideration of adequacy of sample size to draw significant conclusions.

An initial outline of the proposed evaluation design will be refined based on review, comments, and discussions with CMS. The evaluation plan design report will be submitted to CMS within 6 weeks after the kick-off meeting. The design plan will be a “living document”, updated as needed to remain current.

Task 1.4: Final Project Work Plan

The project work plan and time schedule will include at a minimum:

• A brief description of all necessary steps and activities to accomplish the project objectives.

• A description of the organizational structure and functional procedures necessary for the contractor to complete all tasks. This shall include functional descriptions of the tasks and staff by hours by task.

• A description of any assumptions or constraints.

• A discussion of project resource planning.

• A timeline for any data collection and analysis.

• The timeline should include any Paperwork Reduction Act (PRA) clearance that may be required for the data collection for the independent evaluation.

The contractor shall notify CMS when any changes in the project plan affect the ability to complete tasks according to the agreed upon time frame. The work plan will be a “living document”, updated as needed to remain current.

Task 1.5 - Ongoing Meetings/Conference Calls

On a regular basis, the Contractor’s key project staff will participate in conference calls with CMS and, as needed, the Demonstration sites, to discuss the progress of the work, evaluate any problems, and discuss plans for immediate next steps of the project. These calls shall be used as a mechanism for discussing and managing administrative and project issues as they arise. During peak work periods, these calls may occur weekly and reduced in frequency as mutually deemed appropriate.

Task 1.6: Continue Project Management Activities The Contractor shall continue performing the project management activities articulated in the Final Project Work Plan delivered to CMS in Task 1.4; continuing to maintain regular contact with the CMS COR AND SSA COR, submitting timely progress reports, managing and maintaining any required DUAs, and making any necessary revisions to the Project Work and Analysis Plan on an as needed basis in consultation with the CMS COR and SSA COR. CMS considers this to be an informal deliverable that will be provided to CMS and SSA on an ongoing basis throughout the course of the Demonstration.

Task 2: Recruitment and Partnering with Demonstration Sites

Task Overview

Year 1 of this project will be dedicated to the process of recruiting and partnering with Demonstration Sites. The Contractor will assist CMS and SSA in the design of an application for funding and support for an Applicant’s healthcare demonstration.

Subsequently, the Contractor will work with CMS and SSA in systematically evaluating the proposed Demonstration Sites and making the final selection.

Specific Subtasks:

Task 2.1: Design and Implementation of the Demonstration Site Application for Funding and Support The Contractor shall design the application for funding and support to be used by potential Demonstration Sites. This application should allow applicants to present their best case for inclusion into the project as a demonstration site. This application will allow for consideration of potential areas of interest to the analysis as well as potential confounders including but not limited to: geographic region, current programmatic resources for persons of disability, characteristics of beneficiaries within the program’s potential or actual clients.

The Contractor is expected to proposed additional areas of interest. The application process should include site solicitation notices, application instructions and site selection criteria.

The Contractor shall design a fair and transparent evaluation and selection process in collaboration with CMS and SSA. Site visits to determine the extent to which these potential sites satisfy the selection criteria may be necessary. Through the use of this systematic evaluation methodology, CMS, SSA and the Contractor will make the selection of ten Demonstration Sites and selected sites notified.

The Contractor will enter into partnership agreements with the ten Demonstration Sites with the goal of expediting future encounters between the Contractor and the Demonstration Site. The Contractor will furnish Sites with information needed to start the demonstration.

Task 3: Demonstration Implementation

Implementation activities involve the development, preparation and implementation of the plans and strategies necessary to operate the Demonstration project. The Contractor is expected to identify and plan for the wide variety of project areas that need to be monitored during the demonstration. This includes but is not limited to, among others, shared learning system with adult learning activities based on sites’ training needs, face to face learning sessions, clearances for Demonstration implementation, and data collection/analysis needs.

More details of the design and implementation of the learning system in Task 6.

Specific Subtasks

Task 3.1 – Training The Contractor will assess the learning/training needs of the Demonstration Sites. The training may be requested by the Demonstration Sites, by CMS, or by the Contractor.

Potential training needs include but are not limited to: human subjects’ protection, measurement development, data collection protocols, and/or technical training in entering data.

Task 3.2 – Learning Sessions As a key activity of the learning system, the Contractor may need to design implementation activities that use of learning sessions between the Demonstration sites, CMS, and the Contractor. Conferences may be face-to-face, web-based, or audio. The Contractor will address the capacity to perform this function.

Task 4: Implementation Monitoring Activities

Implementation monitoring activities involve continuous oversight and support of the Demonstration. Examples of such activities include: providing technical assistance and consultation to participating sites; collecting and analyzing data from demonstration sites or participants; preparing reports; monitoring the quality of services furnished by participating sites; conducting site visits, and calculating payment rate adjustments and cost estimates in accordance with the specific project design if needed.

Specific Subtasks

Task 4.1 – Technical Assistance In accordance with Demonstration Site requests and needs, the Contractor will provide technical assistance within budgetary constraints in a format acceptable to the recipient.

This may be in any of several formats including webcasts, podcasts, collaboration sites, or site visits. Demonstration Sites may need the assistance of the Contractor in preparing human subjects protection approval from local Institutional Review Boards.

Task 4.2 – Quality Assurance The quality of the data received from the Demonstration Sites needs to be assured using a variety of methods. This may include site visits, audio/video conferencing or training sessions to ascertain fidelity to program protocols, to assure data is entered correctly, and/or problem solving with Demonstration Sites around ways to collect data.

Task 4.3 – Data Integrity and Security The Contractor will need to demonstrate the capacity to receive data from multiple sources securely while maintaining the integrity of the data. The Contractor will develop and present a plan that will allow Demonstration sites to securely transfer data.

Task 4.4 – Payment Rates and Costs Some Demonstration Sites may require the calculation of payment rates, overhead, indirect costs, and other monetary measures in order to monitor for quality improvement. The Contractor will need to be prepared to conduct monetary calculations on an ad hoc basis.

Task 5: Demonstration…