Attachment_J.1_IDIQ_SOW.pdf

Attachment J.1 IDIQ SOW

Measure & Instrument Development and Support

(MIDS)

Statement of Work

IDIQ

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 STATEMENT OF WORK

CHAPTER 1. SCOPE

1.A. – Background

The Centers for Medicare and Medicaid Services (CMS) is the federal agency tasked with overseeing a variety of health care programs, including Medicare and Medicaid. It strives to ensure that the American public receives the highest quality of care, consisting of personalized, prevention-oriented, and patient-centered care, based on evidence about the benefits and costs applicable to each individual patient.

The current health care system does not consistently deliver high-quality care for every patient at every opportunity, resulting in gaps in the quality of care provided for different population groups. Therefore, CMS recognizes the opportunity available to improve the health care system by closing such gaps, thereby further increasing the quality of care for our population.

One way that CMS will carry out its obligation to drive improvement in the health care system is through the development and use of quality measures and related activities. Quality measures are already widely used in several quality reporting programs, including the Hospital Inpatient Quality Reporting Program (IQR) and the Quality Payment Program (QPP). Quality measurement and quality reporting programs are also statutorily required or authorized for settings such as Hospices, Long-term Care Hospitals (LTCHs), Inpatient Rehabilitation Facilities (IRFs), PPS- exempt Cancer Hospitals (PCHs), Psychiatric Hospitals, Hospital Outpatient Departments, and Ambulatory Surgical Centers (ASCs) as well as value-based purchasing programs for hospitals, Skilled Nursing Facilities (SNFs), and physicians, and End Stage Renal Disease (ESRD) centers. Other ways in which CMS carries out its obligation is through the standardization of core health assessment information in CMS’s post-acute care’s patient assessment instrument data, as required under the Improving Medicare Post-Acute Care Transformation Act (IMPACT) of 2014.

CMS seeks to utilize this contract mechanism to develop, implement, and align measures that fill critical gaps for quality priorities. These include measures relating to clinical quality of care, care coordination, population/community health, safety, person- and caregiver-centered experience and outcomes, and efficiency and cost reduction. The tasks under this Statement of Work (SOW) shall be performed under an Indefinite Delivery Indefinite Quantity (IDIQ) contract. Such work shall be performed by one or more Measure and Instrument Development and Support (MIDS) Contractors.

The IDIQ SOW of this MIDS IDIQ contract encompasses all of the fundamental activities that may be required of a MIDS Contractor. However, given the nature of an IDIQ contract, no work will be performed or specifically assigned under this IDIQ SOW. Rather, this IDIQ SOW outlines scope of the work that may be performed only; individual Task Orders (TOs) under the MIDS IDIQ will be awarded for specific duties as the need arises and these TOs authorize expenditures and accomplish SOWs (see below Section G - Contract Administration, for details on TO procedures).

TOs may be awarded by CMS for some or all of the activities identified in this IDIQ SOW. Each TO will contain an individual SOW containing detailed requirements to be performed within the scope of this IDIQ SOW. For example, a TO may be issued for all, or part, of the activities identified in this IDIQ SOW under an individual TO SOW that may read, “The Contractor shall perform all of the requirements of the IDIQ SOW as the maintainer of the Outcome and Assessment Information Set (OASIS).” Alternatively, a TO may be issued for some of the activities, such as, “Coordinate with Post-Acute Care MIDS Contractors to assure Congruent Measure Application.”

1.B. – Purpose

The purpose of this MIDS IDIQ SOW is to procure the services of one or more Contractors by establishing the fundamental activities that may be awarded in subsequent individual TOs.

Further, the purpose of the MIDS IDIQ SOW is to develop outcome, process, structural, cost, and composite quality measures suitable for endorsement by a consensus endorsement entity (CBE) and reflective of quality care across settings, including, but are not limited to, psychiatric hospitals, ambulatory care services, physician providers, accountable care organizations, nursing homes, home health agencies, hospice programs, LTCHs, IHRs, PCHs, acute care hospitals, and ASCs. Its purpose is also to support the collection of data that could be used to trend quality related to patient care for those patients that receive services across settings, as well as other uses related to cross-setting analysis. Such quality care measures would include any aspect of care that is consistent with the Institute of Medicine’s (IOM) Six Aims of Care (safety, timeliness, efficiency, effectiveness, equitability and patient centeredness) and is consistent with current CMS quality priorities.

The Contractor shall explore the dimensions of the measurement in order to generate results that inform the public about how well a provider ensures patient safety, manages symptoms, mitigates poor outcomes, facilitates population health, and enhances coordinated and patient-centered care, with respect to the IOM’s Six Aims of Care. This contract also includes the identification or development of the data elements and items necessary to implement data collection for the proposed measures across settings, as well as the data collection vehicles.

Particularly, this is intended to support the modification and/or development of standardized patient/resident assessment instruments (RAIs) for the collection of data and for interoperable exchange, as laid out in the IMPACT Act of 2014.

This IDIQ SOW further seeks to provide a contracting mechanism to promote the quality of care by emphasizing major strategies for improving care, as noted in the following actions:

• Conduct business through partnerships within CMS, across other Federal and State agencies, other CMS contractors, and non-Governmental entities if requested;

• Publish information for various purposes with varying audience requirements (e.g., diverse audiences that may include the general public, patients/caregivers, professionals, providers, purchasers) so as to convey both general information pertaining to quality reporting and general programmatic education, and more complex technical information pertaining to programmatic requirements, and quality measurements;

• Promote payment adjustments and incentives that express a commitment to quality care and reward improved care outcomes and processes, and does not inadvertently lead to negative unintended consequences;

• Promote the integration of health information technology (HIT) (includes both standards promotion and payment for HIT results) into quality measurement programs;

• Become an active partner in developing and applying knowledge about effective health care technologies to bring innovations to care delivery more efficiently, and to monitor the effectiveness of such federally funded technologies on outcome improvement;

• Promote cross-setting outcome measurement development;

• Implement Health and Human Services (HHS)/CMS’s quality measurement strategic approach;

• Optimize measure development and alignment and application at the conceptual as well as data specification level;

• Enable program monitoring and evaluation for multiple purposes to include identifying unintended consequences; identification of measures that have “topped out” and are candidates for retirement/removal; program integrity; new gaps in quality;

• Enable transparency through public reporting; and,

• Reduce provider burden.

CHAPTER 2. GENERAL REQUIREMENTS

2.A. - Basic Requirements

The MIDS Contractor shall:

1. Furnish the necessary services and qualified personnel (defined as personnel with the skills and expertise to follow the best practices relevant to the work of the project), facilities, equipment, materials, and supplies not otherwise provided by the Government as needed to perform the requirements set forth in this IDIQ SOW and indicated in each individual TO.

2. Provide CMS, and other federal agencies as applicable with complete, timely, and accurate information on all actions upon request.

3. Perform requirements as defined in the IDIQ SOW and future TOs in accordance with (IAW) applicable federal laws, regulations, and manuals.

4. Continuously evaluate the effectiveness of all actions. For example, CMS continually looks for innovation and improved processes when developing clinical quality measures (CQMs). As more CQMs are developed and used in CMS programs, the goal is to be more lean, agile and nimble. This includes developing accurate, well-tested CQMs efficiently with diminishing defects, better measures, and not necessarily more measures.

5. Report IAW the deliverables stated throughout this SOW and in any future TO as applicable.

2.B. - Fundamental Activities

Development, revision, and/or maintenance of assessment instrument data items, data collection vehicles, and performance measures (and their corresponding manuals, public outreach and coordination of data elements and measures with other MIDS Contractors) comprise the fundamental activities of future TOs under the MIDS contract. Although the following sections represent fundamental measures-related activities, they are not meant to be sequential and many of these activities overlap and/or occur in parallel depending on the type of MIDS contract/measures developed.

Additionally, other MIDS TOs performed by MIDS Contractors may require quality measurement program support activities such as public reporting and analytical support. These types of TOs, if needed, will not require all the processes, deliverables, and tools described in The Blueprint for the CMS Measures Management System (MMS) (the Blueprint), described in detail in Section 2.C.2 (Measures Management). Detailed information on the CMS MMS may also be found at: https://www.cms.gov/MMS/19_MeasuresManagementSystemBlueprint.asp.

The data items produced under the MIDS contract allow for the application of and standardization of data elements used in data collection vehicles. Such data elements may be deployed in the multiple assessment instruments, which may also serve as data collection vehicles, for clinical quality measures. These assessment instruments, e.g., data collection vehicles or standardized data item sets, could include, but are not limited to: the LTCH Continuity Assessment Record and Evaluation (CARE) Data Set; the Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI); the OASIS; the Minimum Data Set (MDS), and the CARE for multiple providers. Any updates and future standardized data item set shall also be included. Such data collection sets provide for data element standardization and usability of the data elements in any setting requiring the submission of a standardized data for quality measurement.

A patient-centered approach is critical to improving the quality of care in our country. In order to truly drive improvements in patient outcomes and experience with the health care system, CMS and others must design performance measures that address the needs and values of patients and the people who care for them. Therefore, development of measures, whether they are used for quality improvement, public reporting or value-based purchasing, must be directly informed by patients. Under this IDIQ SOW, all TOs for measure development shall include explicit incorporation of the patient perspectives and preferences in measure development through patient and/or caregiver participation on Technical Expert Panels (TEPs). While participation by patient or consumer advocacy organizations may also be desirable, this IDIQ SOW will require participation by actual patients and caregivers, not just the organizations who represent them.

2.C. – Coordination

Broadly, CMS builds its measure development and maintenance work on six quality priorities:

clinical quality of care, care coordination, population/community health, safety, person- and caregiver-centered experience and outcomes, and efficiency and cost reduction. These focus areas shall drive measure development, selection, and maintenance.

https://www.cms.gov/MMS/19_MeasuresManagementSystemBlueprint.asp

The MIDS Contractor’s success in developing and supporting accurate and reliable quality measures, assessment instruments and standardized data item sets depends on a well-coordinated working relationship between CMS components and external stakeholders. CMS may direct that the MIDS Contractor and its partners collaborate and communicate frequently and regularly to keep each other appraised of potential areas of improvement, and to avoid duplicating efforts.

CMS may also direct the MIDS Contractor to work and coordinate with, to the extent feasible, external entities, such as those described in the following sections.

The MIDS Contractor shall anticipate CMS’ requirement for burden reduction measure simplification, strategic alliance with cross-setting measurement and outcome improvement using a focused approach that will seek to harmonize measurement concept and measurement application across appropriate settings as reflected by the measurement specifications and data elements required to establish and calculate the measures. CMS is working to align, harmonize, and prioritize measure development and maintenance activities across programs and settings.

CMS convenes a number of working groups to review measures or measure sets to determine where opportunities exist for alignment and harmonization. CMS is also actively engaged with various workgroups at HHS and the “National Consensus Development and Strategic Planning for Healthcare Quality Measurement” contractor, National Quality Forum (NQF)-convened Measures Application Partnership (MAP) and National Priorities Partnership (NPP).

The MIDS Contractor must align their Project Management Plan (PMP) with CMS rulemaking schedules and relevant statutory timelines, such as time lines related to the pre-rule-making process required under Section 3014 of the Patient Protection and Affordable Care Act (ACA), rulemaking, Paperwork Reduction Act (PRA) submission, the Blueprint, data submission specification development, and integral deadlines and timelines related to public engagement and web-based postings.

2.C.1. - Other MIDS Contractors

The MIDS Contractor shall coordinate with other MIDS Contractors, as directed by the TO Contracting Officer Representative (COR), to accurately and reliably measure and reflect the level of quality care being provided throughout the health care system. If directed, the MIDS Contractor shall utilize all available tools [e.g., Measures Management Contractor, Quality Information Evaluation System (QIES), the National Data Base, the Chronic Conditions Warehouse, National Claims History, Measures Authoring Tool, etc.] to ensure coordination and prevent duplication of efforts. As a part of its coordination activities, the MIDS Contractor shall participate in information sharing sessions, such as Program/Contractor Status or Updates.

2.C.2. – Measures Management

CMS developed a standardized approach for developing and maintaining the quality measures used in its various quality initiatives and quality reporting programs, known as the MMS. The MMS, overseen through a MIDS TO, is this system composed of a set of business processes and decision criteria that CMS-funded measure developers (or Contractors) follow when developing, implementing and maintaining quality measures. The major goal of the MMS is to provide critical information to the measure developers to help them produce high caliber quality measures that are appropriate for accountability purposes. The MMS was developed to help CMS develop quality measures which can be used to evaluate health care delivery and which can be applied to use in various public reporting and quality programs as well as in value- based purchasing initiatives. The full MMS set of business processes and decision criteria are documented in or described in the Blueprint.

The Blueprint is updated annually by the Measures Manager, given the evolving nature of the quality measurement environment. CMS uses the standardized processes documented in the Blueprint to ensure that the resulting measures form a coherent, transparent system for evaluating quality of care delivered to its beneficiaries. The Measures Management Contractor will provide consultation regarding the application of the Blueprint. CMS may direct the MIDS Contractor to review and comment on the proposed Blueprint updates and work collaboratively with the Measures Management Contractor to integrate the processes detailed in the Blueprint into the activities as specified in future TOs. The MIDS Contractor shall work with their COR, Subject Matter Experts (SMEs) and the Measures Management Contractor to ensure they are working IAW the most up-to-date Blueprint processes, tools, and forms. This ongoing activity includes participating in monthly measures contractor measure development and maintenance coordination meetings to ensure that measures contractors are following vital steps of the MMS Blueprint for harmonization purposes.

Please note: There is a restriction to the MMS TO. Given the purpose of the MMS, the MMS contractor may not hold a CMS TO for quality measure development. However, the MMS contractor may hold a non-measure development MIDS TO that allows the contractor to maintain impartiality to the development process (ex. Education and outreach or annual report).

CMS will evaluate TOs on a case by case basis to determine if there is a conflict of interest.

2.C.3. – State Agencies for Survey and Certification

The MIDS Contractor upon direction of the COR, shall work with State Agencies responsible for quality monitoring, data transmission, receipt and/or analysis in order to coordinate all instrument activities.

2.D. - Project Management

2.D.1. - Project Management Plan (PMP)

For awarded TOs, the MIDS Contractor will be required to develop and submit an integrated PMP that defines the necessary steps (flowchart of activities), milestones, dates, deliverables, dependencies, critical path, and resources needed to execute the contract work as well as a tracking method to update regularly (via dashboard or other as indicated by the TO). This may include but not be limited to the Blueprint activities for measure and patient assessment instrument development, the Information Technology (IT) development life cycle pertaining to data collection item set development, PRA submission, policy-based decisions, public engagement, including the pre-rule-making process required under Section 1890(A) of the Social Security Act (review by the NQF-convened MAP), in order to meet successful program deliverables. The PMP also provides constraints of the project and addresses how the MIDS Contractor proposes to perform the work described under the TO. All project plans shall be modified and updated continuously after the initial submissions to reflect any major changes in the project.

The Contractor shall identify, under Key Personnel, a professional project manager, who has the skills and expertise to follow best practices for the management of a project including the development of a formal work breakdown structure (WBS), timeline, project milestones, critical path, and risk factors. The project manager shall be responsible for collaborating weekly with CMS’ Project Management Oversight Point of Contact, to indicate actions, refinement and progress relative to this contract’s tasks and team responsibilities.

The MIDS Contractor shall specifically be responsible for identifying all dependencies both in relation to what is dependent upon the MIDS Contractor’s project work, and what the MIDS Contractor is dependent upon to carry out its deliverables. The MIDS Contractor shall identify where some project efforts are fully dependent, while others may be attended to in a parallel fashion. This strategic monitoring is essential to ensure the integration of the various activities necessary to meet the complex requirements involved in actualizing all facets of the various CMS programs in their totality, e.g., the Blueprint requirements, rulemaking, training, assessment instrument modification, requirements gathering, PRA submission, data submission specifications, 508 requirements, manual development, etc. noting that some CMS programs may require all aspects of programmatic development while others may be exempt from some aspects (e.g. the MIDS does not require a PRA package to be developed).

In developing the PMP, the MIDS Contractors that are developing measures shall adhere to the following high level steps:

1. Environmental scan (includes data analysis, literature review, etc.)

2. Identify risk and mitigation strategies

3. Quality measure development and maintenance, suitable for Consensus Entity Endorsement

4. Instrument/item development (includes refinement of existing data items or instruments)

5. Field testing/validation

6. Implementation and production

7. Data collection vehicle/assessment tool/standardized data item set development

All measure and assessment development and maintenance-related work shall follow the processes specified in the Blueprint. The Contractor shall dedicate sufficient number of well-qualified staff and labor hours to coordinate their contract activities with the CMS Measures Management Contractor in fulfilling all activities identified in the Blueprint. As directed in the TO, the Contractor may be required to provide the Measures Management Contractor with updates on the progress and status of all measure activities during the regularly scheduled project team call including minutes and agendas.

Deliverable 2-1 (Draft PMP): The MIDS Contractor shall submit a draft PMP during the first 5 calendar days following the award of the TO

Deliverable 2-2 (Final PMP): The MIDS Contractor shall submit a final PMP during the first 15 calendar days following the award of the TO

The draft plan shall include the information described above and shall be submitted in electronic format and hard copy (hard copy only if requested) no later than 5 calendar days after TO award.

The final plan shall be submitted no later than 15 calendar days after the TO award. The Contractor will utilize the PMP to inform and ascertain critical work paths, and guide decisions related to deliverable requirements.

The MIDS Contractor will provide an updated project plan after these initial submissions to reflect any major changes in the project. A major change is defined as an issue or an event that shifts the work or plan by more than 2 business days. When changes are identified, a draft plan shall be submitted for review within 3 business days of identifying the change. CMS will provide comments within 5 business days and the final plan will be due 5 business days after receipt of CMS comments. If CMS comments are not received within 10 business days, the draft plan becomes final.

The draft PMP shall minimally include the following:

1. Details of the work to be performed

2. Key staff types devoted to each activity, if appropriate, and time allocation for each

3. Key bi-directional dependencies

4. Unique CMS requirements as applicable to each program

5. Key milestones signifying successful completion of each activity and periodic internal assessment/progress reports planned

6. Activity interdependency and critical path for completion

The MIDS Contractor shall maintain a working PMP which is updated with revisions or changes on a regular basis, at least monthly. All changes to the PMP must be reviewed and approved by the COR.

2.D.2. - Kickoff Meeting

Deliverable 2-3 (Kickoff Meeting): Under an awarded TO, a Kickoff Meeting shall be held no later than 30 calendar days after the TO award unless otherwise negotiated with the COR.

At the Kickoff Meeting, the MIDS Contractor shall work with CMS personnel to develop a PMP. The MIDS Contractors shall invite the Measures Management Contractor and Measures Manager COR or arrange for a separate meeting with the Measures Management Contractor to review Blueprint processes, forms, and tools. The MIDS Contractor shall be responsible for providing meeting minutes and deliverables for all activities no later than 3 business days following each meeting.

The Kickoff Meeting minutes shall include, at a minimum, the following information:

1. A list and timeline of all deliverables necessary to ensure completion of the activities described in the TO SOW.

2. Reporting expectations

3. Other general TO expectations and milestones

2.E.- Deliverables

Timely deliverables are critical to the success of the MIDS contract. Timely is defined as the deliverables being received by all parties by the due date referenced in the deliverable schedule in a manner that complies with CMS data security policy, especially if the deliverables contain personal health data or confidential data. Due dates will include the preliminary due dates needed for CMS review of draft documents and collaboration with other various agencies and CMS components. All deliverables shall meet 508 compliance guidelines.

For email deliverable submissions, the received date is the date the deliverable is emailed by the MIDS Contractor to the recipient(s). Hard copy mail delivery (if requested by the COR) is considered received on the date it arrives in the hands of the recipient(s). If deliverables are required in both electronic and hard copy, the email copy must be submitted by the due date. If the MIDS Contractor anticipates problems with a deliverable, it should take steps to forward the deliverables earlier than the due date so that problems can be resolved prior to the due date.

Deliverable 2-4 (Submittal of all Deliverables): The MIDS Contractor shall submit to their COR, at the end of the TO year, an electronic package in an agreed upon format containing all the deliverables listed in the TO SOD.

2.F. – Ad Hoc Requests

Deliverable 2-5 (Ad Hoc Requests): CMS may need information on an ad hoc basis regarding its Contractors’ activities. The MIDS Contractor shall provide such information upon request.

For measures developed using complex statistical methodologies, the MIDS Contractor shall have staff with graduate-level training in advanced statistical methods, and working knowledge in CMS claims, patient assessment and/or survey data, and work experience in federally-funded national studies on topics related to health outcomes, health care costs and utilization, and quality. Additionally the Contractor should have technical writers to ensure that requested deliverables are well-written and clear. Examples of ad hoc requests may include but not be limited to responding to reports in publications or other sources (e.g., the impact of $4 retail prescriptions on the validity of claims- based measures), trend reports of exclusion use, and activities which support other Contractors as directed by CMS. The number of ad hoc requests will be identified at the TO level.

Deliverables in Chapter 2:

Deliverable 2-1 (Draft PMP) Deliverable 2-2 (Final PMP)

Deliverable 2-3 (Kickoff Meeting) Deliverable 2-4 (Submittal of all Deliverables) Deliverable 2-5 (Ad Hoc Requests) Deliverable 2-6 (To Be Determined (TBD), if necessary) Deliverable 2-7 (TBD, if necessary)

CHAPTER 3. INFORMATION GATHERING

Under an awarded TO, the MIDS Contractor shall be required to gather and analyze data and information relating to activities specified in the TO SOW in the form of an environmental scan and empirical data analysis of all pertinent data/information sources.

Information gathering is the first step in the development of new measures or the maintenance of existing measures or can be used for other purposes related to measure or program evaluation and implementation. Information gathering shall provide a significant knowledge base that includes quality goals, the strength of scientific evidence (or lack thereof) pertinent to the topics/condition of interest for the specific TO, as well as information with which to build a business case for the development of a measure(s) or for maintaining a measure(s). Refer to the Blueprint for additional information related to information gathering. Relevant steps shall be followed for the patient/RAI modifications, for example, in relation to the modification of assessment instrument data elements in the SNF/Nursing Facility RAI MDS.

For such TOs, the MIDS Contractor must initially gather a variety of information and conduct analysis to assess the concept or domain discussed in the TO SOW for the measures to be developed or maintained to determine the following four criteria that have been adopted from the IOM: importance/relevance, scientific soundness, usability/actionability, and feasibility.

Example Blueprint requirements associated with information gathering as specified under an awarded TO may include:

Deliverable 3-1 (Information Gathering Report): Information Gathering Reports shall include a summary report of the Environmental Scan and Empirical Data Analysis and other information.

Deliverable 3-2 (List of Potential Measures): List of potential measures Deliverable 3-3 (Measure Information Form (MIF)): Documentation on MIF (Note:

Contractors begin to fill in some of the fields in the MIF) Deliverable 3-4 (Measure Justification Form (MJF)): Documentation on MJF (Note:

Contractors begin to fill in some of the fields in the MJF) Deliverable 3-5 (Business Case Development): Development of the business case for measure concepts, topics, and/or candidate measures.

3.A. – Environmental Scan

This can be done via various methods, such as literature review, clinical performance guideline search, interviews, or other activities. At a minimum, for the development of new measures and patient assessment data elements, the scan shall identify current applicable measures and data elements that might be appropriate for the specific TO, through research with the following sources: employers, commercial plans, managed care plans, Tricare, NQF, MedPac, IOM, Institute for Health care Improvement (IHI), Veterans Health Administration (VHA), Department of Defense (DOD) and the NPP.

In conducting the scan, consideration should also be given to the CMS Quality Measurement Task Force Goals, as well as Medicare top volume and top cost conditions. As specified in the TO, the Contractor may be required to conduct a literature review and scan the Internet for relevant sites, peer-reviewed journal articles, gray literature, competing measures, and other reliable sources of information relating to the topic.

The Contractor may be expected to conduct an additional environmental scan of existing performance measures for the purposes of developing measures that facilitate high quality care, such as those that measure quality related to safety and adverse events, health care acquired conditions, such as health care-associated infections, and those that measure quality related to patient-centered care, such as symptom management, care coordination, and readmissions. The Contractor may include, in the establishment of measures and the modification of assessment instruments, any aspect that will be used to drive high quality care. It is important that such measures be consistent with the IOM’s Six Aims of Care: safety, timeliness, efficiency, effectiveness, equitability and patient centeredness. The Contractor shall explore the dimensions related to quality, in various ways, in order to generate performance measures that inform the public about how well a provider manages patient care, e.g., care coordination, ensuring safety and symptom management, with respect to the IOM’s Six Aims of Care.

The Contractor shall prepare a report of the Environmental Scan activities conducted to document their findings. Activities shall include, but are not limited to:

1. Search for related or similar measures (and data elements) as well as competing measures, and identify opportunities for harmonization and alignment.

2. Clinical guidelines pertinent to the clinical domain or topic specified in the SOW.

3. Studies that document the success of particular measures in the same or similar health care setting or domain covered in the SOW.

4. Scientific evidence to support the clinical leverage points, such as importance, on which measures can be based.

3.B. –Expert Input

CMS may direct the MIDS Contractor to solicit input from a variety of sources as a step in the development of new measures, evaluation/maintenance of existing measures, or for other purposes, as directed by a specific TO. Input may be solicited from industry-related professional organizations and associations, clinical, and technical experts through such means as stakeholder groups, Open Door Forums, structured interviews, Listening Sessions, etc. Input should, where appropriate, specifically include clinical expertise and SMEs from within the Federal Government agencies, e.g., the Department of Veterans Affairs (VA), Centers for Disease Control and Prevention (CDC), DOD as well as from the public sector.

Deliverable 3-6 (Expert Input Report): The Contractor shall summarize the input referenced in the above paragraph in the Expert Input Report.

3.C. - Data Analysis

If data is available, the Contractor may be directed to conduct an empirical data analysis to provide statistical or other evidence to support the selection of the topics, conditions, or potential measures and to assist in the development of the business case for the topics, conditions or measures. Data analysis is conducted to achieve several objectives. These activities may include, but are not limited to:

1. Provide analysis to inform CMS policy decisions.

2. Provide the evidence that informs inclusion or exclusion criteria related to population groups or geographical regions into measure/item specifications.

3. Provide evidence for the identification of specific clinical topics, and performance measurement needs.

4. Provide evidence/justification for the business case to select or develop measures.

5. Provide data validation plan, or directly apply specific strategies that will ensure accuracy in reporting.

6. Provide evidence of evaluation factors that may influence measure performance, such as health literacy and social and demographic factors.

3.D. – Summary Report

Under the awarded TO, the Contractor shall provide a narrative report of the information gathered (Information Gathering Report - Deliverable 3-1), to include, but is not limited to (specific requests may be made upon each TO award):

• Summary Report of Environmental Scan findings

• Input from technical experts or other stakeholders

• Empirical Data Analysis findings

• Business Case for the concept, topic, condition, and/or potential measure(s).

3.E. – Reporting Information Gathering Costs

When reporting Information Gathering costs following an awarded TO, the MIDS Contractor shall include any hours and associated costs dedicated to pre-measure/item development that includes data analysis, literature review, etc. and/or other activities meeting the characteristics described in IDIQ SOW Chapter 3 (Information Gathering) and included in the specific TO.

Deliverables in Chapter 3:

Deliverable 3-1 (Information Gathering Report) Deliverable 3-2 (List of Potential Measures) Deliverable 3-3 (MIF) Deliverable 3-4 (MJF) Deliverable 3-5 (Business Case Development) Deliverable 3-6 (Expert Input Report) Deliverable 3-7 (TBD, if necessary) Deliverable 3-8 (TBD, if necessary)

CHAPTER 4. QUALITY MEASURE DEVELOPMENT & REEVALUATION

The Quality Measure Development Activity represents those activities associated with refining, enhancing, developing, or modifying only performance measures to include ratios, rates, and/or composite measures.

4.A. – Quality Measure Development

Under an awarded TO, the MIDS Contractor shall develop performance measures including electronic Clinical Quality Measures (eCQMs) based on the domains/concepts/priorities defined in each TO SOW. The Contractor shall utilize the Blueprint to guide measure development and maintenance. As part of this process, measures must undergo public input as noted therein.

Based on the results of the information gathered, measures that are specific and relevant to the domains/concepts/priorities described in the TO SOW shall be developed. The Contractor shall work with their COR, appropriate SMEs, and the Measures Management Contractor to ensure they are working IAW the most up-to-date Blueprint process, tools, and forms.

New Measure Development/Adaptation of Existing Measures

Please note for the information provided in this section: Some of the criterion does not apply to certain types of measures. CMS requires the application of NQF’s most recent version of measure criteria for each of the subsets of measures, which can be accessed at www.qualityforum.org.

The following criteria shall be considered during the process of new measure development/ adaptation of existing measures. These criteria align with the measure evaluation criteria below, established by a CBE, including, but is not limited to, the CBE currently under contract with the Secretary under §1890 of Title XVIII of the Social Security Act. However, to note, Contractors must reference the Blueprint for additional information and the most current criteria:

1. Impact, Opportunity, Evidence—Importance to Measure and Report: extent to which the specific measure focus is evidence-based, important to making significant gains in quality, and improving health outcomes for a specific high-impact aspect of care where there is variation in or overall less-than-optimal performance. Measures must meet all three sub-criteria to pass this criterion and be evaluated against the remaining criteria.

a. High Impact – The measure focus addresses:

1. A specific national health goal/priority identified by HHS or the NPP convened by the CBE;

OR

2. A demonstrated high-impact aspect of health care (e.g., affects large numbers of patients and/or has a substantial impact for a specific population segment; leading cause of morbidity/mortality; high resource use (current and/or future); severity of illness; and severity of patient/societal consequences of poor quality).

http://www.qualityforum.org/

AND

b. Performance Gap – demonstration of quality problems and opportunity for improvement, i.e., data demonstrating considerable variation, or overall less- than-optimal performance, in the quality of care across providers and/or population groups (disparities in care).

AND

c. Evidence to Support the Measure Focus − The measure focus is a health outcome or is evidence-based, demonstrated as follows:

• Health outcome: a rationale linking a specific health outcome to processes or structures of care.

• Intermediate clinical outcome, Process, or Structure: a systematic assessment and grading of the quantity, quality, and consistency of the body of evidence that the measure focus leads to a desired health outcome.

• Patient experience with care: evidence that the measured aspects of care are those valued by patients and for which the patient is the best and/or only source of information OR that patient experience with care is correlated with desired outcomes.

• Efficiency: evidence for the quality component as noted above.

d. Measure focus is supported by the quantity of evidence, strength of evidence, and consistency of results in the body of evidence.

• Quantity of Body of Evidence: total number of studies (not articles or papers)

• Quality of Body of Evidence: certainty or confidence in the estimates of benefits and harms to patients across studies in the body of evidence related to study factors including: study design or flaws; directness/indirectness to the specific measure (regarding the population, intervention, comparators, outcomes); imprecision (wide confidence intervals due to few patients or events). Study factors include: a) Study designs that affect the strength of evidence may include, but are not limited to: the design and implementation of randomized controlled trials (RCTs), which, in theory, control for both observed and unobserved confounders, and the design and implementation of non-RCTs (observational studies), which tend to vary in the level of control for observed confounders, b) Study designs that may bias estimates of effect include, but are not limited to: lack of allocation concealment; lack of blinding;

lack of adjustments (sampling or statistical) for large losses to follow-up; failure to adhere to study protocols; stopping early for benefit; and failure to report important outcomes.

• Consistency of Evidence: Stability in evidence related to both the direction and magnitude of clinically/practically meaningful benefits or harms to patients (benefit over harms) across studies.

2. Reliability and Validity—Scientific Acceptability of Measure Properties: extent to which the measure, as specified, produces consistent (reliable) and credible (valid) results about the quality of care when implemented. Measures must meet the sub-criteria for both reliability and validity to pass this criterion and be evaluated against the remaining criteria.

a. Reliability

i. The measure is well defined and precisely specified so it can be implemented consistently within and across organizations and allow for comparability. Electronic Health Records (EHR) measure specifications are based on the quality data model

(QDM).

ii. Reliability testing demonstrates that the measure results are repeatable when assessed in the same population in the same time period and/or that the measure score is precise.

iii. Reliability is ensured through the use of uniform, standardized data elements that are used to collect focused-assessment information (in a standardized format).

Information collected using such data elements enables the calculation of a measure and ensure a consistent, systematic approach to information gathering. This allows for quality measurement implementation across settings at the data element level.

b. Validity

i. The measure specifications are consistent with the evidence presented to support the focus of measurement under criterion 1c. The measure is specified to capture the most inclusive target population indicated by the evidence, and exclusions are supported by the evidence.

ii. Validity testing demonstrates that the measure data elements are correct and/or the measure score correctly reflects the quality of care provided, adequately identifying differences in quality.

iii. Exclusions are supported by the clinical evidence; otherwise, they are supported by evidence of sufficient frequency of occurrence so that results are distorted without the exclusion;

AND

If patient preference (e.g., informed decision-making) is a basis for exclusion, there must be evidence that the exclusion impacts performance on the measure; in such cases, the measure must be specified so that the information about patient preference and the effect on the measure is transparent (e.g., numerator category computed separately, denominator exclusion category computed separately).

iv. For outcome measures and other measures when indicated (e.g., resource use):

• An evidence-based risk-adjustment strategy (e.g., risk models, risk stratification) is specified; is based on factors that influence the measured outcome (but not factors related to disparities in care or the quality of care) and are present at start of care; and has demonstrated adequate discrimination and calibration.

OR

• Rationale/data support risk adjustment/stratification is not necessary or feasible.

v. Data analysis of computed measure scores demonstrates that methods for scoring and analysis of the specified measure allow for identification of statistically significant and practically/clinically meaningful differences in performance;

http://www.qualityforum.org/Measuring_Performance/Submitting_Standards/Measure_Evaluation_Criteria.aspx#note15

There is evidence of overall less-than-optimal performance.

vi. If multiple data sources/methods are specified, there is demonstration they produce comparable results.

c. Disparities: if disparities in care have been identified, measure specifications, scoring, and analysis allow for identification of disparities through stratification of results (e.g., by race, ethnicity, socioeconomic status, gender);

Rationale/data justifies why stratification is not necessary or not feasible.

3. Feasibility: the extent to which the required data are readily available or could be captured without undue burden and can be implemented for performance measurement (Note: not all measures programs receive incentives/adjustments for performance measurement).

a. For clinical measures, the required data elements are routinely generated and used during care delivery (e.g., blood pressure, lab test, diagnosis, medication order).

b. The required data elements are available in EHRs or other electronic sources. If the required data are not in EHRs or existing electronic sources, a credible, near-term path to electronic collection is specified.

c. Susceptibility to inaccuracies, errors, or unintended consequences and the ability to audit the data items to detect such problems are identified.

d. Demonstration that the data collection strategy (e.g., source, timing, frequency, sampling, patient confidentiality, etc.) can be implemented (e.g., already in operational use, or testing demonstrates that it is ready for operational use).

4. Usability and Use: extent to which intended audiences (e.g., consumers, purchasers, providers, policymakers) are using or could use performance results for both accountability and performance improvement to achieve the goal of high quality and efficient health care for individuals or populations.

a. Accountability and Transparency: demonstration that performance results of a measure are used or can be used in public reporting, accreditation, licensure, health IT incentives, performance-based payment, or network inclusion/exclusion.

AND

b. Improvement: demonstration that performance results facilitate the goal of high quality efficient health care or credible rationale that the performance results can be used to further the goal of high quality efficient health care.

AND

c. Benefits of the performance measure in facilitating progress toward achieving high quality efficient health care outweigh the evidence of unintended consequences to individuals or populations (if such evidence exists).

5. Harmonization: extent to which either measure specifications are harmonized with related measures so they are uniform or compatible or the differences must be justified (e.g. dictated by evidence).

a. Related measure: the measure specifications for this measure are completely harmonized with a related measure.

b. Competing measure: this measure is superior to competing measures (e.g. a more valid or efficient way to measure quality); OR has additive value as an endorsed additional measure (provide analyses if possible).

c. Application of measures across settings using standardized, uniform data elements for measures.

d. The Contractor will develop and update, as needed, the data collection vehicles/assessment instruments to ensure the implementation of measurement alignment, and measure application, per endorsement requirements. Such alignment shall include data element harmonization where applicable. They will ensure appropriate collaborative efforts with other MIDS Contractors, and others as directed, to ensure oversight of data element harmonization and subsequent updates.

The Contractor may be required to use additional criteria as determined by CMS IAW the Blueprint and as specified in the TO. The Contractor shall consult with the Measures Management Contractor if the Contractor is required to use additional criteria.

4.A.1. - Technical Expert Panels (TEP)

Under an awarded TO, the MIDS Contractor shall, as appropriate, identify and recruit a group of nationally recognized experts in the relevant fields, including clinicians (physicians, pharmacists and registered nurses), statisticians, quality improvement experts, methodologists, consumers, experienced measure developers, and EHR vendors to work with the measure contractor to develop the technical specifications and business case for measure development, review testing results, and to identify potential measures for further development or refinement. Each TEP shall have at minimum of one patient or caregiver on its roster in order to provide input into quality issues that are important to patients. The Contractor, shall, in turn, propose the list of measures to CMS. Refer to the TEP section of the Blueprint.

The MIDS Contractor shall follow the Blueprint in convening a TEP to include, but not be limited to:

Deliverable 4-1 (TEP Composition Documentation Form): Convene a TEP by issuing a call for TEP on the CMS website. Select a balanced panel that specifically includes persons/caregivers, and clinical experts that may exist outside of the provider stakeholder groups.

IAW Deliverables 3-1, 3-2, and 3-6: Prepare and disseminate materials for the TEP.

Deliverable 4-2 (Measure Evaluation Report for Each Measure): Conduct the TEP meeting via conference call, WebEx or in person.

Deliverable 4-3 (Summary of TEP Evaluation of Measures): Document and summarize the TEP’s review, input, discussions of the measures. Propose recommended set of measures to

CMS.

Other Blueprint requirements associated with convening a TEP include:

1. Call for TEP member nominations.

2. TEP Nomination/Disclosure/Agreement forms.

3. TEP Charter.

4. TEP membership list.

5. Meeting materials and minutes.

6. Potential measures presented to the TEP.

7. Measure Evaluation reports.

8. If the MJF and MIF are modified after the…