Attachment_J.9-A_SOW_TO_0001_Rev_1.pdf

Attachment J.9-A SOW TO 0001 Rev 1

Measure & Instrument Development and Support

(MIDS)

Statement of Work

Sample Task Order 0001

Development, Reevaluation and Implementation of

Outcome Measures

A. Statement of Work (SOW)

CHAPTER 1. SCOPE

1.A. - Background

This project is to develop, reevaluate, and implement the Centers for Medicare and Medicaid

Services (CMS) outcome and efficiency measures.

The measures shall include measurement for acute and chronic diseases and primary and preventative care for distinct patient populations (such as healthy children, chronically ill adults, or infirm, elderly individuals). The measures shall also include the full scope of services that comprise a cycle of care.

1.B - Purpose

The purpose of this MIDS TO is to obtain services for the development, re-evaluation, and implementation of an innovative mix of up to 3 de novo measures (e.g., process and outcome measures {including intermediary outcomes} that align with CMS Meaningful Measures (see

Appendix A)), cost and resource use measures, electronic quality measures, patient-reported outcome measures (PROMs) and patient-reported outcome performance measures (PRO-PMs) whereby each outcome measure has cross setting capability as demonstrated by meeting the requirements for inclusion in 3 or more current CMS Quality Reporting Programs (See Appendix

B), using relevant data sources including claims, registry and electronic health records (EHR)-based data.

This TO SOW adheres to all tasks within the MIDS Indefinite Delivery Indefinite Quantity

(IDIQ) Statement of Work (SOW) Chapters. Note: Chapter 5 is optional, depending on whether a program related to the post-acute care (PAC)/long-term care (LTC) setting is included.

CHAPTER 2. GENERAL REQUIREMENTS

In accordance with (IAW) Chapter 2 of the MIDS IDIQ SOW, the Contractor shall carry out all work/tasks described in sections 2.A., 2.B., 2.C.1., 2.C.2., 2.D.1., 2.D.2., 2.E., and 2.F.. Tasks described under section 2.C.3. (State Agencies for Survey and Certification) shall not be performed under this TO SOW.

Additional Requirements:

IAW section 2.A., Basic Requirements: The Contractor shall participate in CMS Lean Process

Improvement activities (or an alternate innovative reasonable approach like Agile or Design

Thinking), such as leading and coordinating current state and future state mappings of measure development processes and indicate where appropriate Lean techniques have been applied to the measure development process, or where Lean improvements will result from the proposed measures.

IAW section 2.C., Coordination: The Contractor shall indicate where measure development and maintenance activities are coordinated with external measure stewards, such as The Joint

Commission (TJC), other MIDS Contractors, and Department of Health and Human Services

(HHS) agencies, and where specific communications and collaboration with said groups will occur as part of the measure development process.

IAW section 2.F., Ad Hoc Requests from CMS: The Contractor shall carry out activities which support CMS or CMS contractors, to engage stakeholders who are clinicians and/or professionals in practice (e.g., leaders in health plan organizations, Quality Improvement Directors, vendors and so on) in focus groups or workgroups to identify and address measure development and implementation priorities, related to electronic clinical reporting, burden reduction, negative unintended consequences and similar priority areas, as directed by the Contracting Officer’s

Representative (COR). Please assume CMS will request 1 Ad Hoc request per year. Therefore, the contractor shall assume CMS will request 5 Ad Hoc requests over the whole TO Period of

Performance.

CHAPTER 3. INFORMATION GATHERING

IAW Chapter 3 of the MIDS IDIQ SOW, the Contractor shall carry out all work/tasks described in sections 3.A., 3.C., and 3.E. Tasks 3.B. and 3.D. shall not be performed under this TO SOW.

IAW section 3.A., Environmental Scan: The proposed information gathering process and environmental scan shall be targeted to describe the elements of the measure justification, conceptual framework, gap analysis, and opportunity for improvement that align with CMS priorities for decreasing reporting burden and alignment across multiple (at least 3) settings.

CMS prioritizes measure development based on performance gaps addressing our national priorities that address high-cost, high-volume issues that drive ongoing quality improvement.

Topic areas for measure concepts shall be aligned with the Meaningful Measure areas as noted in

Appendix A.

IAW section 3.C., Data Analysis: The Contractor shall conduct empirical data analysis to provide statistical and other evidence to support the development of measure concepts and provide a summary in the proposal. The Contractor shall prepare and submit an initial business case for each proposed measure concept according to the Measures Management System (MMS)

Blueprint (Appendix C).

CHAPTER 4. QUALITY MEASURE DEVELOPMENT &

REEVALUATION

IAW Chapter 4 of the MIDS IDIQ SOW, the Contractor shall carry out all work/tasks described in sections 4.A. and 4.C. The contractor is not required to perform the tasks in 4.B. The

Contractor shall use the latest version of the MMS Blueprint to guide the measure development and maintenance/reevaluation processes (link provided in Appendix C).

IAW section 4.A.1., Technical Expert Panels (TEPs): The Contractor shall identify and recruit technical experts, according to the MIDS IDIQ SOW and the MMS Blueprint requirements, to provide expert input on the proposed measure concepts. The TEP shall meet via teleconference or Webinar/WebEx. In person meetings require specific rationale and justification by the

Contractor. The Contractor shall establish methods for gaining patient perspective and input on measures during and following the measure development process and may consider innovative methods of recruiting and including national experts in the field for the TEP as well as patients and family/caregiver representatives that may not be included in the MMS Blueprint. The TEP shall also engage providers/clinicians in practice in the measure development process if applicable and to the extent possible.

IAW Section 4.A.5., Consensus-Based Entity (CBE) Endorsement: The Contractor shall prepare and submit documents for submission of new measures to the CBE. Currently, the CBE is the National Quality Forum (NQF) (https://www.qualityforum.org/Home.aspx). The

Contractor shall provide necessary technical support of the measure for the CBE endorsement process. Support may include responding to CBE committee questions, preparing memos, providing additional analyses and evidence, responding to public comments, and participating on conference calls with the CBE.

CHAPTER 5. INSTRUMENT/ITEM DEVELOPMENT

IAW Chapter 5 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 5.A. – 5.D, if applicable to the proposed measures and setting (PAC/LTC). To clarify, the contractor will need to develop, test, etc., de novo standardized patient assessment data elements and may have to develop cross setting, standardized patient assessment data elements for the PAC assessment instruments. Such data elements must also be made interoperable, so will have to be able to be associated with Health Information Technology (HIT) vocabularies.

Also, the contractor shall ensure that the submission specifications are correct and can ideally craft them. The contractor shall be able to develop the measure specifications for the assessment based measures using the submission specifications.

CHAPTER 6. TESTING/VALIDATION

IAW Chapter 6 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 6.A. – 6.D. For the post PAC quality measure reports (if applicable), the contractor shall perform parallel analysis on the calculation of the measures done by the Quality

Improvement and Evaluation System (QIES) system. Also, the contractor shall be able to work with the CMS Information Systems Group (ISG) for ensuring that requirements are conveyed for the provider reports, to include preview, feedback quality measure reports and public reporting files.

IAW section 6.A., Reliability and Validity Testing: The Contractor shall conduct all required reliability and validity testing according to requirements stated in the MIDS IDIQ SOW and the http://www.qualityforum.org/Home.aspx)

MMS Blueprint.

IAW section 6.B., Types of Testing: The Contractor shall consider reliability and validity testing for any risk adjusted outcome measures and describe the need and approach for these tests during the measure development or re-evaluation process.

IAW section 6.B.1., Alpha Testing (Formative Testing): The Contractor shall conduct alpha testing according to the MMS Blueprint requirements. The alpha testing for new measures must be done with the business case from section 3.C. of this TO SOW.

IAW section 6.B.2., Beta Testing (Field Testing): The Contractor shall conduct beta testing according to the MMS Blueprint requirements. The Contractor shall update Measure

Information Form (MIFs) and methodology reports with the analyses and findings from beta testing.

IAW section 6.C., Reports from Testing: The Contractor shall prepare and submit a testing plan for new measures.

CHAPTER 7. REPORTS/APPROVAL PACKAGES

IAW Chapter 7 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 7.A. – 7.H.

CHAPTER 8. IMPLEMENTATION, PRODUCTION & ASSESSMENT

IAW Chapter 8 of the MIDS IDIQ SOW, the Contractor shall carry out all work/tasks described in sections 8.A.1., 8.A.2., 8.A.3., 8.A.5., 8.C., 8.D., and 8.E. Tasks in sections 8.A.4. and 8.B.

shall not be performed under this TO SOW.

IAW section 8.A.1., Measure Selection and Rulemaking Process, the Contractor shall conduct pre-rulemaking support according to the MIDS IDIQ SOW if applicable.

IAW section 8.A.2., Development of Rollout/Implementation Plan: The Contractor shall prepare and submit communication materials to support the implementation and public reporting of new measures. The communication materials shall include Frequently Asked Question (FAQ) sheets, fact sheets, and updated methodology reports.

9. PUBLIC REPORTING/COMPARE SITES

IAW Chapter 9 of the MIDS IDIQ SOW, the Contractor shall carry out all work/tasks described in sections 9.A. and 9.I. Tasks described in sections 9.B.-9.H. shall not be performed in this TO.

IAW section 9.A., Coordination with other CMS Components: The Contractor shall provide technical support to the CMS Compare Site Contractor as directed by the TO COR, including providing written documents and participating on conference calls. This may include support for

Agile development depending on the Quality Reporting Program for which the measure is intended.

CHAPTER 10. ACCESS TO SYSTEMS/DATA

IAW Chapter 10 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in section 10.A. Additionally, the contractor shall comply with all CMS IT System and

Security standards.

CHAPTER 11. QUALITY ASSURANCE AND PERFORMANCE

EVALUATION

IAW Chapter 11 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 11.A. – 11.D.

CHAPTER 12. TRANSITION FROM INCUMBENT TO SUCCESSOR

IAW Chapter 12 of the MIDS IDIQ SOW, the contractor shall carry out all work/tasks described in sections 12.A. – 12.D.

B. Key Personnel Requirements:

Having the appropriate skill mix is essential to completing the tasks outlined in this SOW.

This section lists the key personnel required to complete this work and the rough level of effort required to complete this work.

The following positions are considered Key Personnel for this TO:

Project Director, Project Management Professional (PMP) with demonstrated informatics expertise, Doctor of Philosophy (PhD) preffered – 1.0 full-time Employee (FTE) (1800 hours)

Clinical Director (a Physician), minimum Doctor of Medicine (M.D.) prepared – 75% of 1 FTE

(1350 hours)

C. References:

Appendix A:

Meaningful Measures:

Appendix B:

The following CMS Reporting Programs are to be considered for cross-setting applicability of the proposed measures:

1. Ambulatory Surgical Center (ASC) Quality Reporting

2. End-Stage Renal Disease (ESRD) Quality Incentive Program

3. Home Health Quality Reporting

4. Hospice Quality Reporting

5. Hospital Acquired Condition Reduction Program

6. Hospital Inpatient Quality Reporting

7. Hospital Outpatient Quality Reporting

8. Hospital Readmission Reduction Program

9. Hospital Value-Based Purchasing Program

10. Inpatient Psychiatric Facility Quality Reporting

11. Inpatient Rehabilitation Facilities Quality Reporting

12. LTC Hospitals Quality Reporting

13. Medicare Part C

14. Medicare Part D

15. Medicare Shared Savings Programs

16. Nursing Home Quality Initiative

17. Prospective Payment System-Exempt Cancer Hospitals Quality Reporting Program

18. Quality Payment Program, which has two tracks: the Merit-based Incentive Payment

System (MIPS) and Alternative Payment Models (APMs)

19. Dialysis Facility Compare (DFC)/ESRD Quality Initiative

20. Skilled Nursing Facility (SNF) Quality Reporting Program

21. SNF Value-Based Purchasing Program

22. Core Set of Children’s Health Care Quality Measures for Medicaid and Children’s

Health Insurance Program (CHIP) (Child Core Set)

23. Core Set of Health Care Quality Measures for Adults Enrolled in Medicaid (Medicaid

Adult Core Set)

24. Quality Rating System (QRS)

Appendix C: (Link to MMS Blueprint)

MMS Blueprint Link:

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-

Instruments/MMS/Downloads/Blueprint-130.pdf https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-130.pdf https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-130.pdf