SECTION_C.pdf

RFP: 75FCMC19R0003

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SECTION C – DESCRIPTION/SPECIFICATIONS/ STATEMENT OF WORK

C.1 Background

The Centers for Medicare & Medicaid Services (CMS) is the Federal agency responsible for the operation and oversight of the Medicare and Medicaid programs and the Federal participant in State-operated Medicaid programs and the Children’s Health Insurance

Program (CHIP). CMS’ mission is to assure health care security for the general public through the management of programs that include Medicare, Medicaid, and State

Children’s Health Insurance Programs and to provide leadership in the broader health care marketplace to improve the health of all citizens. As an effective steward of public funds, CMS is committed to strengthening and modernizing the nation’s health care system by putting patient needs first, creating more flexibilities at the state and local level, and providing access to high quality care and improved health at lower costs. This also aligns with the four strategic goals for CMS. To help accomplish this mission, CMS was given broad authorities through legislation to test innovative models of care delivery and payment to determine whether they can maintain or improve quality and reduce cost, are sustainable, and are feasible for broader scale application. This work includes the development, implementation, monitoring, analysis, technical assistance, and rapid cycle evaluation of such models, building collaborative learning networks to disseminate best practices, developing necessary technology to support this activity, conducting rapid cycle analysis of the programs and participants, and rapid reporting of interim findings and summative findings as feasible.

Under this Research, Measurement, Assessment, Design, and Analysis (RMADA)

Indefinite Delivery Indefinite Quantity 2 (IDIQ) umbrella contract, the Centers for

Medicare & Medicaid Services (CMS) shall award task orders (TOs) for a wide range of analytic support and technical assistance activities that support models and demonstration programs created or derived under the auspices of the Patient Protection & Affordable Care

Act (ACA), the Medicare Access and CHIP Reauthorization Act (MACRA), other non-

ACA statutes, and future health reform legislation. The demands of new reforms created under ACA have redefined the way CMS approaches and conducts research activities, Model Testing, and demonstrations affecting Medicare, Medicaid, CHIP, and uninsured populations. The role of state and private sector payers is also being redefined, as many of the new models include multiple payers working in collaboration with CMS to reform the care delivery system. Note: when the term model/demonstration is used throughout this work statement, CMS is also referring to other Innovative State based programs. The

RMADA 2 IDIQ contract shall provide CMS with a robust tool to meet these needs and opportunities. The Contractor shall work with CMS on matters including but not limited to:

Supporting all aspects of model design and operations (with the exception of information technology);

Conducting program, data and environmental analyses;

Assisting with application development and review;

Monitoring model site implementations;

Designing and carrying out surveys and other primary data collection activities;

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Obtaining and analyzing secondary data sources including data regarding Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) and data from private payer sources needed to support model design, operations and evaluations;

Reporting on formative and summative analyses;

Providing rapid cycle evaluation feedback to CMS and/or model participants, and

Creating summative reports of annual and final program findings.

Assist in the development of program templates, tools, toolkits, and driver diagrams;

Support stakeholder engagement and training;

Provide data analysis/ integration support;

Assist in the development of program specific technical/policy resource guides and informational/ educational/ briefing materials;

Provide grant proposal reviews and summarization reports

In addition to the aforementioned list of required tasks, the Contractor may be asked to work with CMS on matters pertaining to developing and implementing learning systems to support accelerated learning, improvement, and dissemination of promising practices.

C.2 Technical Considerations

i. Information Technology Systems

RMADA 2 is not an Information Technology (IT) contract vehicle. CMS does not intend to use this IDIQ to develop new CMS IT systems. An IT system is a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information. [National Institute of Standards and

Technology Special Publication (NIST SP) 800-53]. A CMS IT system has these characteristics:

Stores CMS data;

Requires hardware, network, and software resources (whether at a CMS or

Contractor facility);

Collects or sends data to other users or systems; and

Processes data (data collection, logic, business rules, etc.).

The Contractor shall not create a formal CMS IT system through RMADA 2 task orders

(unless CMS approves an exception). The Contractor shall not

Develop a system that requires completing the CMS Expedited Lifecycle (XLC);

Develop a system that requires obtaining a new Authority to Operate (ATO). All

CMS IT systems must obtain an ATO before startup and “go-live”; or

Host public facing web-based systems in its corporate facilities that store CMS data.

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CMS has dedicated contract vehicles for developing IT systems. The Contractor shall collaborate with CMS’ IT Contractor to ensure that CMS has the IT capabilities needed to operate and evaluate models. The Contractor may be required to collaborate with IT

Contractors and model teams to identify requirements, assist with User Acceptance

Testing, and operate the systems (e.g., help desk coordination, data entry). When necessary, the Contractor shall execute a Joint Operating Agreement (JOA) with CMS-designated Contractors. The JOA shall define the roles and responsibilities and create mutually agreed-upon and cost-effective methods to work together in support of the CMS mission. A JOA clearly describes the work that needs to be accomplished and the roles and responsibilities of each signatory for the success of the task or project. It includes specifics about who shall do what, when, and for whom. The Contractor may be asked to participate in monthly status calls with IT support Contractors and applicable model staff.

CMS recognizes that the Contractor may have innovative ideas for IT capabilities that can benefit models. The Contractor may propose IT capabilities and systems to CMS in response to task order requests for proposal. However, the Contractor shall not develop the proposed system unless CMS explicitly approves. IT staff in the CMMI/Business Services

Group and Office of Information Technology shall review the proposed IT capabilities and systems. If IT staff and the COR approve the Contractor to develop a system, it shall follow the requirements of the CMS XLC and the CMS Information Systems Security and

Privacy Policy (IS2P2).

ii. Data

CMS distinguishes between IT systems development and the use of data to perform analysis. To perform RMADA 2 task orders, the Contractor shall access and use data from

CMS and other sources. CMS expects the Contractor to use databases, files, and software that CMS provides such as the Chronic Conditions Warehouse, Integrated Data Repository, and the CONNECT collaboration platform. CMS recognizes that the Contractor may need to use analytical tools such as Structured Query Language (SQL), SAS, and other Business

Intelligence tools to analyze CMS data.

The Contractor shall:

Explain the technical approach in detail using the guidelines presented in C.2.A .

The details at the minimum shall include the data sources, tools of choice, and use of CMS assets with in CMS environment.

Maximize the use of CMS data within CMS facilities instead of extracting data to its corporate facilities. CMS facilities include the CCW’s Virtual Research Data

Center (VRDC) and the IDR’s Data Labs.

Store its analytical code in a CMS source code repository such as GitHub (the CMS instance) or Endeavor. Analytical code includes SQL and SAS programs.

Submit a written justification to the COR if it wants to extract CMS data to its corporate facilities (e.g., extract CMS claims data for storage in a corporate facility). The justification shall include the reason for extracting the data and the planned use.

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If approved to extract the data, the Contractor shall:

a. Complete a Data Use Agreement (DUA) and comply with its terms ( terms can be found on WWW.CMS.GOV) ; and

b. Safeguard the data according to the Federal Information Security Management

Act (FISMA) and CMS’ IS2P2. FISMA applies to Federal Agencies, business partners administering federal programs (such as states and private businesses in a contractual relationship with CMS); and all Federal data regardless of its location and stewardship. CMS’ IS2P2 policy applies to any contract, agreement, or other arrangement that collects, creates, uses, discloses, or maintains sensitive information, including but not limited to Personally

Identifiable Information (PII) and Protected Health Information (PHI).

iii. Design of Materials

The Contractor’s deliverable materials shall reflect principles and best-practices in information design. This is the practice of making information easy to understand and remember. The Contractor may use concepts from overlapping disciplines, such as plain language, human centered design (HCD), interaction design, and usability. CMS may require the Contractor to adopt elements of federal style that already reflect information design expertise, such as the font choices and icons of the US Web Design System.

iv. Model Characteristics

Models authorized under the ACA and more recent legislation are different from past CMS demonstrations and evaluations, and often include the implementation of learning systems for participants. The scope of activities of these models include all areas of health care research: costs, access, quality, service delivery models, financing, and payment approaches. These models are larger, more complex, and may be scaled without

Congressional approval if programs demonstrate cost savings while maintaining or improving quality. These highly visible models draw intense interest and scrutiny from market and oversight stakeholders, the press, and policymakers. These models often are closely integrated with existing national programs and other models in testing. Such interactions must be carefully anticipated, understood, and managed to account for complex legal, operational, and policy priorities. These models also typically move from design to announcement and implementation in less than a year, requiring adherence to deadlines and strong coordination across Contractors and CMS.

Expectations for support of today’s models have also evolved. Unlike past demonstrations, greater emphasis is being placed on supporting more than one phase of a model. This requires close coordination with CMS and the ability to respond quickly to evolving situations. This work may require the expertise of multi-disciplinary staff including:

economists, physicians and other health professionals, pharmacists, social scientists, actuaries, statisticians, public health & health policy analysts, improvement scientists, project managers, training specialists, public/media relations staff, and systems analysts.

Contractor staff must also have a wide range of health care, Medicare payment/health

Pg. 8 of 149 policy expertise. Contractor staff should have knowledge of the Innovation Center’s model life cycle framework used to facilitate model design, announcement and award, implementation, monitoring, evaluation and close-out. Contractors should also possess the analytic and management ability to accurately assess program risks, develop contingency plans, and if necessary, implement them in a manner that adequately balances risk, cost, and time to market. Because CMS engages model participants in a collaborative manner, support staff must be able to provide intensive technical assistance in an accessible, client-oriented manner and at scale to all model participants. Additionally, the Contractor shall have the ability to adequately staff multiple large scale CMS models at the same time.

Evaluations of models are based on ongoing analyses using real-time claims and utilization data. These fluid and evolving analyses create a need for:

Periodic reports for all models rather than just those at risk;

Continuous feedback to providers as part of improvement efforts;

Analytic designs that incorporate regression-based approaches as well as actuarial approaches;

Analytic designs that integrate qualitative and quantitative results; and

The development of various reports tailored to specific audiences (e.g., social scientists, mid- and executive-level management, and political staffs).

This continuous feedback provides insight into factors associated with process improvement and helps CMS understand factors that drive the success or failure of the relevant models and recommend changes accordingly. Because many CMS Model

Tests involve collaboration across multiple payers and entities, analysis and evaluation approaches must also account for the need to gather, coordinate, and analyze private payer and other data sources, as appropriate.

C.3 Requirements

Tasks required under this RMADA 2 IDIQ contract include, but are not limited to:

i. Model Design: Business Case Development

For models conducted under CMS authority, CMS leadership authorizes development of the initial concept into a fully formed business proposal, referred to as an Innovation

Center Investment Plan (ICIP).

The business proposal (or ICIP) describes the opportunity for improvement in care delivery and payment, defines the problem being addressed, and proposes a theory of action. This theory of action is supported by an analysis of the evidence base, target audience and beneficiaries, factors driving change, operational risks, barriers to change, a plan for monitoring progress, and the potential return on investment. The Contractor may be requested to assist in the development of some non-sensitive materials describing the model that may be used during the government’s decision-making or clearance process.

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The Contractor shall perform tasks related to supporting CMS in designing a model to test an innovative payment and/or service delivery model. The Contractor may be asked to complete or support such tasks as the following:

1. Conduct literature reviews, evidence assessments, environmental scans, and market research, including but not limited to development of the products described below.

a. Exploratory Analyses: The Contractor shall propose a plan for conducting an environmental scan and literature review of the evidence. The Contractor shall provide relevant evidence and examples to support problem/concept definition, preliminary model design, and assessments of the strength of the opportunity.

The Contractor shall provide a strategy for exploring the availability of primary and/or secondary data available for model operations and/or evaluation as needed.

b.Program Analyses: The contractor shall provide environmental scanning and other pre-implementation activities, such as financial modeling, development of data collection tools, Monte Carlo simulation, risk profiling, episodic construction, attribution methodologies, and developing and testing algorithms that shall be used to make various payments separate from that being performed by any evaluation contract. In addition, the contractor shall create synergy between the various models through design. Specifically, the contractor shall assess the impact/influence of risk and uncertainty in financial, project management, and cost for forecasting future models.

c. Utilization Management Analyses: The Contractor shall review the utilization management programs of relevant health plans, which may include the types of personnel responsible for making prior authorization decisions, the policies for determining medical necessity, and any special consideration in applying utilization management guidelines.

d. Written Briefing Materials and participation in briefings: The Contractor shall provide a summary report(s) that integrate findings from the literature review and data analyses, identify current gaps in knowledge, present refined study questions, and give options to further address policy issue(s). Reports and briefings should also include relevant parameters and recommendations for further action. The Contractor may be responsible for drafting and/or editing the ICIP or any ensuing ICIP Amendment, including work on specific elements of the ICIP, such as the following:

Providing support on defining the problem and opportunity;

Requirements and business process modeling;

Legal and operational concerns;

Identification of target populations;

Evaluation of available evidence;

Documentation of risks and assumptions in the proposed model; and

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Preparing written briefing materials and conducting oral presentations.

2. In coordination with CMS, the Contractor shall develop recommendations for model goals . Specific Model Design & Operational Features shall clearly define what is being tested, by whom, where, how long, and the specific purpose of the tests. Based on a general project design, the Contractor shall prepare a preliminary design detailing the relevant research questions of interest and how the questions of interest shall be addressed.

3. The Contractor shall identify regulatory and policy issues and requirements, including identification of necessary waivers.

Identify beneficiary population and target geographic locations and options;

Identify provider populations;

Identify specific intervention strategies, benefits, and/or financing changes;

Identify payment operational requirements and strategies; and

Identify data operational requirements and collection strategies.

4. The Contractor shall obtain Federal, state, and private health care sector data, as needed or requested. The Contractor shall be knowledgeable about available data sources. Examples include but are not limited to:

Claims available through the CMS Virtual Research Data Center (VRDC) including fee-for-service (FFS), Medicare Advantage (MA), and Medicaid claims;

All-payer claims databases (APCD)

Enrollment/eligibility information;

Survey data; and

Data provided by states.

Contractors shall be knowledgeable and required to work in CMS environments including the VRDC, Integrated Data Repository (IDR), and the mainframe.

Contractors shall provide an approach that obtains data directly from the CMS data sets and/or other appropriate sources.

Contractors are required to propose appropriate, timely, and cost effective ways to access and obtain the necessary data. This work could include obtaining:

Medicaid data directly from states or sites;

Hospital level data from the AHA survey;

Physician practice data from Management Group Management Association;

Data from other publically available data sources; and/or

Data from CMS.

Primary data collection may also be required. The Contractor shall work with CMS to identify the best data source. CMS will work with the Contractor to facilitate

Pg. 11 of 149 access to existing CMS data collection tools as appropriate. The Contractor shall be responsible for obtaining any necessary Data Use Agreements (DUAs) and for adhering to CMS data security policies and procedures.

5. For the purposes of both assessing evidence base and promoting stakeholder engagement,the Contractor shall consult with and/or engage experts internal and external to CMS, serving as an education and outreach liaison.

In coordination with CMS, the Contractor shall consult with and/or engage experts internal and external to CMS. Experts may include public and private sector resources; federal and/or State officials; or other experts as required to refine policy issues and identify additional data sources or reports to be examined. The

Contractor may be required to develop and carry out a detailed plan for managing expert engagement. The plan shall include but is not limited to compiling, analyzing, assessing, and incorporating input into activities and ICIP development, as appropriate. Relevant phases of a task order include:

Stakeholder outreach and readiness assessment during the design phase;

Creation and approval of education and outreach materials during the announcement, award, and implementation phases;

Analysis of Stakeholder interest and potential engagement during the implementation, and analysis/evaluation phase; and

Analysis of Stakeholder receptivity and dissemination opportunities during the report writing phase (for annual or summative reporting).

6. The Contractor shall support or produce, as requested, evaluations of intervention strategies, benefits, risks, and financing options.

7. The Contractor shall consider, in cooperation with CMS, the potential impact of design decisions on the approach for the model evaluation.

8. The Contractor shall assist in or produce, as requested, assessments of the evaluability of different design options for any Model Test being developed. This work might include but is not limited to

Determining, using statistical tools, power calculations, and justifiable assumptions about likely behavioral responses under the model, the sufficient sample sizes necessary to answer key questions;

Providing analyses of data availability and justifications for assumptions regarding data availability, as well as contingency plans, as appropriate; and

Analyzing the overlap and effects of competing programs and other factors in the marketplace that might dilute the impact of the intervention or contaminate the comparison group.

9. The Contractor shall, as requested, analyze Return on Investment (ROI) for different design options for any Model Test being developed.

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The Contractor shall propose a plan to develop estimates of ROI for various program design options in order to assist CMMI in selecting the option that is most likely to meet the ROI objectives while also meeting other objectives such as high quality health service delivery.

ii. Technical Assistance – Application Support

The Contractor shall perform tasks related to providing Technical Assistance in support of the Application process for CMS Model Tests, including but not limited to the following tasks:

1. Provide support and consultancy with CMS in all aspects of administering the solicitation/application (used interchangeably) process, including but not limited to:

developing business requirements, providing support/help for applicants using a web-based application process that CMS provides, and providing support/help/consultancy for the model team as it solicits and evaluates applications and proposals.

2. Assist CMS with development of a scoring rubric/methodology to assign scores to any

Request for Application (RFA) or Notice of Funding Opportunity (NOFO), identifying, training, and convening reviewers/technical expert panels, collecting their scores, and providing them with technical assistanace during the application evaluation process.

3. Conduct readiness reviews of applicants and scale to the appropriate size of the model, as requested, determining whether applicants can meet Model Test requirements for such factors as start-up timing, level and quality of care, staffing, training, management, self-monitoring and reporting, IT support, including but not limited to

Electronic Medical Records, capacity, ability to accept risk, and when appropriate, integration of care. The Contractor shall be expected to provide readiness reviews that cover the entire spectrum of care (primary care, acute care, long term services and supports, behavioral health, etc.);

4. Assess and monitor potential and/or continuing model participants for program integrity issues.

5. Assist CMS in developing briefing materials and Decision Memos regarding recommendations for the selection of participants and awardees in models.

6. If needed, revise waiver cost estimates or financial models, and knowledge of the approporiate mathematical formulation to reflect the results of the solicitation process to include in a clearance package.

It should be noted that models that are grant / cooperative agreement programs may not require the same level of support. In such cases, some of the above tasks may be completed by a specialized contract or by CMS personnel. In these instances, the

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Contractor shall consult their Contracting Specialists or Contracting Officer Representative for additional details.

iii. Design, Implement & Evaluate

The Contractor shall help design operational processes, provide technical assistance, and carry out an appropriate monitoring approach. The approach shall identify potential unintended consequences of the program, detect whether participants are making progress and quality improvements, and assess whether programmatic requirements are being adequately followed. The monitoring activity shall serve as a primary source of information for tracking activities within the model operations. This may include general operational progress such as improvements in services furnished by participating providers and performance progress such as improvements in care quality, care experience, or other measureable indications and model efficiency measures.

The Contractor shall propose a plan to perform the following tasks:

1. During the Pre-Implementation (Build) Phase

1. Provide orientation and ongoing technical assistance to model participants

The Contractor shall develop an approach for providing support to model participants related to a variety of operational activities including, but not limited to:

the use and proper maintenance of data;

rationale for interpretation of findings;

payment;

evaluation;

data collection;

quality/performance measurement;

data sharing;

establishing an inquiry system/process and/or help desk to respond to inquiries; and

Collaboration with other CMS contractors to provide subject matter expertise for support of the various models.

In addition to the aforementioned list of required activities, the Contractor may be asked to develop an approach with respect to learning and diffusion.

The Contractor shall demonstrate the capacity to proactively address participants’ information needs and use a variety of media to provide training, including webinars, conference calls, face-to-face meetings, and written materials to educate them about protocols.

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2. Provide technical assistance for self-administered design plans

In many models, awardees are expected to conduct an evaluation of their own projects, separate and apart from CMS’ independent evaluation. Where applicable, the Contractor shall provide technical assistance for the design of Awardees’ self-evaluations. The goal of this task is to ensure that the design and execution of the self-evaluation plan is feasible and informative. Further, this technical assistance should, to the extent possible, correct deficiencies in self-evaluations that would significantly impact CMS’ ability to independently evaluate the proposed projects.

However, this task should not impede progress on completing other tasks.

3. Develop and prepare initiative-specific standard operating procedures & programmatic protocols (e.g., in regard to payment administration, marketing, grievances and appeals, and stakeholder input).

The Contractor shall assist CMS in ensuring that all operational policies and procedures for participating stakeholders are catalogued, accurate, and kept up-to-date. This includes reviewing policies and procedures developed and distributed by

CMS and the Contractor to identify areas needing further clarification or revision based on inquiries or model experience, as well as proposing language for inclusion in written policies and procedures for practices.

4. Develop operational requirements and manage data files for enrollment/attribution, including developing outreach strategy/materials, claims algorithms, etc.; and maintain master enrollment lists of beneficiaries and/or providers (comprehensive and point in time).

The Contractor shall work with CMS to organize and synthesize administrative and programmatic data collected and maintained by the Contractor. This data may include, but is not limited to, periodic attribution and payment information. The

Contractor shall make this data available to other CMS Contractors for purposes of model or agency needs on a periodic basis as directed by CMS.

5. Providing enrollment support to CMS and model participants.

Providers and/or beneficiaries may enroll in Models through a variety of methods, including active (recruitment) or passive (attribution) methodologies. The

Contractor shall provide support to CMS in:

Running attribution methodologies;

Preparing and maintaining current lists of model participants, taking into account potential overlaps with other programs;

Entering participants into the CMS Master Database Management system

(MDM), as needed; and

Conducting appropriate information exchanges with the CMS Center for

Program Integrity (CPI) and the Division of Technical Payment Policy, the

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Office of the Inspector General (OIG), the Department of Justice, and other enforcement bodies, as directed by CMS.

In order to be shared, data must have the appropriate level of encryption. Guidance regarding data encryption and transmission is provided by CMS as part of the data use agreement process and CMS policies for handling data. For manual exchange of data between federal agencies, privacy requirements for both agencies must be met. (See C.2.A on page 2)

6. Develop model-specific and cross-model quality strategy

The Contractor shall support a number of initiatives across CMS in support of quality performance assessment and improvement for Alternative Payment Models.

The Contractor shall have expertise in:

Health services research;

Quality performance measurement;

Quality measure development and the re-specification of existing quality measures, (for example, re-specification of a claims based measure to an

Electronic, Clincial, Quality, Measure (eCQM), or a change in measure specification inclusion criteria to a different age range);

Clinical quality and claims data analytics; and

Statistical methodologies to support development of a model’s quality strategy including the development of a quality payment incentive methodology.

The Contractor shall support models in the early design and implementation phase for all types of models. The Contractor shall develop standardized processes to identify appropriate quality measures for model(s) at various stages in the model lifecycle and ensure the identified quality measures meet the goals of the model’s payment design, participants, patient population, and the regulatory needs the of the model.

Obtain the measure specifications;

Obtain the necessary approvals to use the measures from the government liaisons (e.g., measure stewards);

Perform literature reviews and/or search quality measure databases to identify appropriate measures;

Identify the method for quality data collection;

Develop the benchmarking methodology and perform sample size calculations as needed;

Conduct technical expert panels, if needed;

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Liaison with the National Quality Forum (NQF) regarding any measure questions/changes to an already NQF-endorsed measure and its implications for continued use;

Conduct ad hoc analyses as needed (for example, use historical data to determine if a model population has sufficient case size for reliability of a measure); and

Assist with the design of the quality performance-based payment as needed.

Develop materials as needed for meetings with the CMMI Quality

Innovation Council (QIC);

Work with other CMS contractors to ensure data integration and/or reporting of quality metrics from CMMI models to other CMS programs is performed as needed.

The Contractor shall develop a limited number of new measures that fill identified gap areas in performance measurement for alternative payment models and also re-specify existing measures to meet model needs.

The Contractor will need to develop or re-specify measures under tight timelines so that the measures could be used within the model’s planned years of operation.

The Contractor would be expected to support multiple models concurrently, if applicable. The Contractor may also provide administrative support to a center-wide quality committee and develop standard operating procedures, agendas, and meeting documents.

The measures developed or re-specified shall be designed specifically for inclusion in models that are typically different than those used in CMS quality reporting programs. Quality measure work will require specifications and testing for use of the measure in many settings, across many types of providers, and in different model designs (e.g., in Bundled Payment models, Accountable Care Organizations).

The contractor shall support all other quality measure work for the model including the testing of new measures as they are introduced in the model (with the exception of quality data collection). The need to re-specify a measure or develop a measure should be performed so that it does not interrupt the model lifecycle and other operations.

The Contractor shall create/maintain processes for collecting performance data;

obtain appropriate claims, survey, and clinical data for measurement; conduct necessary training for participants; and use existing IT platforms and software as appropriate. The Contractor may be required to determine performance benchmarks, calculate quality scores, perform site reviews and audits where required, and create performance reports for participants. Information regarding nuances of Medicare claims data is available through Research Data Assistance

Center, Resdac: http://www.resdac.org/. Other information that cannot be obtained through retrospective claims-based analyses may need to be collected through http://www.resdac.org/

Pg. 17 of 149 surveys or other mechanisms that are project specific. The Contractor shall propose appropriate supplemental data collection techniques.

7. Develop core measures

Other quality initiatives the Contractor may perform include the design, implementation, and analysis of Center-wide core quality performance measures. Core quality performance measures are measures that would be used in every model across CMS. The Contractor may be asked to develop a plan to identify appropriate measures for use across all models, implement the measures, collect the data from all model participants, and conduct data analyses both within models and across models. This work may also involve design, administration, and analysis of a survey for assessing patient-reported outcomes measures. The

Contractor would administer this survey to a sample of patients from each model participant and communicate the results back to the model participants in a timely fashion, and then would re-survey the same patient cohort at a pre-determined interval. The Contractor would develop the data benchmark methods, perform meta-data analyses, and develop reports for models participants, CMS leadership, and the public.

8. Provide quality improvement reviews

Additional quality initiatives may include performing an assessment of individual models to improve the quality of care based on predetermined quality measures or quality improvement data from each model. The quality improvement review may be done annually for each model and also may include a center-wide report that compares all models against preset strategic objectives.

9. Develop operational requirements and systems for sharing data, including processes for administering data use agreements

Propose a viable strategy for implementing the transfer of data files to participants and to CMS and its Contractors in order to ensure timely transfer of data files to participants and compliance with all CMS data use requirements, including establishing data use agreements with all model participants, as needed. The

Contractor shall propose a plan to ensure accurate documentation of participation/data sharing status for beneficiaries/patients and providers.

10. Payment operations and administrative activities

The Contractor may be asked to collaborate with the Innovation Payment

Contractor (IPC) in relation to payment operations and administrative activities. These services available to any model on contract with the IPC may include:

Establish Bank account for the disbursement of funds to model payees;

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Disburse Electronic Funds Transfer (EFT) or paper check payments to eligible Medicare and Medicaid providers and beneficiaries;

Apply Federal Payment Levy Program (FPLP) withholding for each payee;

Issue demand letters, conduct collection activities (payment offset/ withholding and/or pay and chase) and report on receivables;

Manage/monitor recoupment debt repayment plans;

Process debt referrals to Treasury;

Make adjustments to payments including accounts payable/receivable netting as required;

Manage model bank accounts;

Send IRS 1099s annually to all payees;

Provide proper funds control, oversight and compliance with all applicable laws, regulations, Federal Accounting Standards, Generally Accepted

Accounting Principles, Office Of Financial Management (OFM) guidelines and reporting requirements in compliance with the CMMI internals controls;

Additionally the IPC is currently/can perform the following additional tasks at the behest of CMMI:

o Work with other CMS centers and contractors to integrate with other new and existing systems o Currently working towards the Healthcare Integrated General Ledger

Accounting System (HIGLAS) integration;

o Currently housed on the fully ATO’d Small business Health Options

Plan (SHOP) Premium Aggregation Services (PAS) Center for

Consumer Information and Insurance Oversight (CCIIO) infrastructure to make payments with National Government Systems (NGS) performing annual recertification of the ATO;

o Currently developing interface with Provider Enrollment Chain and

Ownership System (PECOS) and the Shared Systems to automate and verify provider banking data;

o Serve as a financial service resource providing CMMI with expertise and advice in all areas of payment servicing.

11. Provide payment audit support

The Contractor shall review all SAS or other analytical code and other relevant materials prepared by the payment Contractor and provided by CMS, as well as produce original analytical work. The Contractor shall consult with the payment

Contractor as necessary at the request of CMS.

a. Audit and validate

The Contractor shall validate the payment calculation performed by the payment Contractor through the duration of the contract. The Contractor shall audit and validate the payment Contractor’s calculations for each episodic period for newly submitted claims and updates to previous claims. It is expected

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CMS in a timely fashion after receipt of the payment Contractor’s initial calculations.

The Contractor shall provide CMS with a written report of the results of the payment calculation validation, along with a summary file and report. The

Contractor shall utilize work from the payment Contractor that CMS provides to refine the written reports, summary file, and summary report per the direction and approval of CMS. The summary report must contain documentation of discrepancies between the summary file and the results provided by the payment Contractor. The Contractor shall provide the data files used for each calculation as requested by CMS.

The Contractor shall provide CMS with a written report of the results of the validation work, clearly documenting any discrepancies between the two

Contractors’ results. The report shall include variables such as dates falling within the model, all assumptions made in performing calculations, and outputs of the financial calculations as performed by the Contractor. It is expected that this task will vary episodically.

b. Recoupment validation

The Contractor shall audit and validate the payment Contractor’s calculation of the amount that must be paid or recouped by CMS for actual expenditures that are either above or below the target price. The Contractor shall generate reports and summary files of auditing and validation work as directed by CMS.

12. Develop a viable process for responding to beneficiary/provider inquiries

The Contractor shall support CMS in interface with 1-800-Medicare, state Medicaid agencies, or other organizations and/or conduct other approaches for monitoring beneficiary concerns related to the administration of the model. Some of these activities shall be, but are not limited to, developing FAQs, analyzing complaints, and development of scripts.

13. Develop viable operational requirements for monitoring

The Contractor shall assist CMS in providing ongoing monitoring and oversight of models, determining needs, obtaining the necessary data, and conducting all relevant analyses, as requested. Such data collection and analysis activities shall be based on data from participants, CMS, and secondary data sources, as well as on routine surveys, other primary data, and ad hoc data. The frequency at which the

Contractor must obtain secondary data may be as frequent as monthly or may be as frequent as quarterly collection for primary data. The frequency could change with each task order issued.

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14. Perform quantitative and qualitative analyses

The various types of data should be obtained as defined by the deliverable established by a specific proposal, methodologically sound, robust, comprehensive, and appropriate to the respective research questions and the target audiences.

Analyses may need to incorporate extensive analysis of performance and evaluation data in order to ensure that learning is focused on those elements of models where the data appears to demonstrate that the intervention has been effective or ineffective. Upon identification of potential issues of concern, the Contractor shall notify CMS or a CMS Contractor with auditing responsibilities for further investigation of any suspicious patterns and trends.

15. Maintain critical systems of record

a. The Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration

(NARA) records policies, including but not limited to the Federal Records

Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter

XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are

Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the

Government and must be managed in accordance with Federal law.

Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

d. The Contractor shall take the annual HHS records management training.

16. Provide and support stakeholder engagement / outreach

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The Contractor shall provide and support stakeholder engagement activities related to development, announcement, award, implementation, and evaluation of model tests. This work shall include, but is not limited to, the following work:

a. The Contractor shall work collaboratively with CMS to document and execute CMS’ education and outreach plan. The plan may integrate with other related CMS Innovation Center communication efforts and may need to be refined throughout the period of performance. The education and outreach plan may focus on areas such as:

b. Reaching all stakeholders with appropriate user-specific information

c. Providing details about eligibility

d. Connecting stakeholders with appropriate tools and resources

e. Increasing participation and performance by clinicians

f. Monitoring and evaluation of activities

g. The Contractor shall develop, update, determine how to present, and curate program education and outreach products to effectively reach internal and external stakeholders with information needed to successfully participate, and to support CMS’ efforts to educate both users and stakeholders. In producing all materials, the Contractor shall assure integration of CMS branding elements and compliance with CMS communications policies and guidelines in all products and strategies. Materials should be developed to conform to plain language principles. Materials for Internet use shall be mobile-friendly (iOS and android) and viewable with all common web browsers, including but not limited to Safari and newer versions of Internet

Explorer.

h. The Contractor shall execute and administer, in collaboration with CMS, a process for direct communication with external stakeholders to obtain feedback. To support this effort, the Contractor shall work with CMS and execute a stakeholder communication plan to convene and organize

Listening Sessions, Town Halls, National Stakeholder Calls, develop and maintain email distribution lists, and offer other methods of direct communication with stakeholders.

i. In collaboration with CMS, the Contractor shall identify best practices and success stories and determine a strategy to publish them, such as on the

CMMI website. For example, the Contractor may collect testimonials and/or peer based learning information that can be published online in a variety of formats (web, video, etc.).

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j. The Contractor shall monitor one or more external feedback channels such as e-mail inboxes, using best practices and adhering to applicable technical requirements. The purpose of the external feedback channels is to receive education and outreach inquiries (including, but not limited to requests for

CMS speakers and program- related questions).

k. The Contractor shall develop and produce materials necessary to support the customer journey and optimize the user experience in a manner that describes the link to CMS and CMMI quality and value goals.

l. Materials will be produced across a number of formats, including print, online (including mobile-friendly), audio, and video. Materials should be consumer-friendly (simple and intuitive to understand), be informative and actionable for the target audiences, provide clarity, reduce confusion and consumer anxiety. Based on user and stakeholder needs, the Contractor shall manage these products as syndicated content that can be distributed through multiple partner channels and mediums as appropriate. These products may include, but are not limited to:

Frequently Asked Questions

Infographics

Timelines

Fact Sheets

User Guides

Presentations

Drop-in articles

Tip sheets

Listserv message content

Social Media specifically for Twitter

Podcasts

Web-based learning modules

Templates; and

Resource Guides

m. Regardless of format, all Web content or communications materials produced, including text, audio or video, shall conform to applicable

Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All Contractors

(including subcontractors) or consultants responsible for preparing or posting content shall comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents. Remediation of any materials that do not comply

Pg. 23 of 149 with the applicable provisions of 36 CFR Part 1194 as set forth in this

SOW shall be the responsibility of the Contractor or consultant.

n. Developing, in cooperation with specific model teams, the Division of

Stakeholder Engagement and Policy, and the Office of Communication, Rollout Plans and Strategies for model-related announcements.

o. Developing and supporting implementation of a Rollout Timetable

(referred to as a “Tic Toc”) for key activities showing the critical path of each of the key elements during the 48 hours prior to and just after any major announcement.

p. The Contractor shall have the capacity to translate materials into Spanish, upon CMS request, and also into as many as five other languages, as determined by each model team.

17. Financial analysis and forecasting

a. Prepare forecasts reflecting a model’s expected savings, spending, and return on investment (ROI), during testing and upon expansion, both individually and for the model portfolio in aggregate;

b. Provide sophisticated support for the collection and analysis of CMMI’s model performance and health care data relevant to financial estimating and forecasting under this Statement of Work;

c. Ensure that model savings and return on investment financial forecasts are updated and aggregated to support individual model decisions at key points in the model life-cycle, as well as portfolio-wide decisions; that these decisions take into account the most up-to-date and comprehensive Center-wide long-term spending forecasts; that…