MIDS_Sources_Sought_attachmentl.doc

APPENDIX I: SAMPLE STATEMENT OF WORK

1. Scope 1.A. – Background: tc "A.

Background " \l 3 The Center for Medicare and Medicaid Services (CMS) is the federal agency tasked with overseeing a variety of healthcare 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 among the healthcare population. Therefore, CMS recognizes the opportunity available to improve the healthcare 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 such as the Hospital Inpatient Quality Reporting Program (IQR) or Physician Quality Reporting System (PQRS). In addition, quality measurement and public reporting programs are statutorily required in settings and programs such as Hospices, Long-term Care Hospitals, Inpatient Rehabilitation Facilities, PPS-exempt Cancer Hospitals, and Psychiatric Hospitals. Most recently, value-based purchasing programs have been established for hospitals and physicians, building upon CMS’ initial value-based purchasing program, the End Stage Renal Disease Quality Improvement Program.

CMS seeks to utilize this contract mechanism to develop, implement, and align measures that fill critical gaps within the National Quality Strategy (NQS) and its six domains. 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 work under this statement of work 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 umbrella Statement of Work (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 umbrella SOW. Rather, this umbrella statement of work outlines scope of the work that may be performed only; individual Task Orders under the MIDS Umbrella will be awarded for specific duties as the need arises and these task orders authorize expenditures and accomplish SOWs (see below Section G - Contract Administration, for details on task ordering procedures).

Task Orders may be awarded by CMS or other government agencies identified herein for some or all of the activities identified in this umbrella SOW. Each Task Order (TO) will contain an individual statement of work containing detailed requirements to be performed within the scope of this umbrella SOW. For example, a Task Order may be issued for all, or part, of the activities identified in this umbrella SOW under an individual Task Order SOW that may read, “The Contractor shall perform all of the requirements of the umbrella SOW as the maintainer of the Outcome and Assessment Information Set (OASIS).” Or, a Task Order 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: tc "B.

Purpose " \l 3 The purpose of this Umbrella Statement of Work is to procure the services of one or more MIDS Contractors by establishing the fundamental activities that may be awarded in subsequent individual Task Orders. Further, the purpose of the Measure & Instrument Development and Support (MIDS) Indefinite Delivery/Indefinite Quantity (IDIQ) Umbrella Statement of Work (USOW) is to develop outcome, process, structural, cost and composite quality measures suitable for endorsement by a consensus endorsement entity and reflective of quality care for healthcare settings, such as psychiatric hospitals, ambulatory care services, physician providers, accountable care organizations, nursing homes, home health agencies, hospice programs, long-term care hospitals, in-patient rehabilitation facilities, PPS-exempt cancer hospitals, acute care hospitals, and ambulatory surgical centers. Its purpose is to also support the collection of data that could be used to trend quality related to patient care for those patients that move 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), is consistent with the National Quality Strategy (NQS), and is in alignment with CMS’ three Aims (Better Care, Better Health, Lower Costs through Improvement) and Quality Measurement Strategy. The contractor shall explore the dimensions of the quality measures in order to generate measures that inform the public about how well a provider ensures patient safety, manages symptoms, mitigates poor outcomes, facilitates population health, and ensures 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 the health care continuum, as well as the data collection vehicles.

This umbrella Statement of Work further seeks to:

Provide a contracting mechanism to promote the quality of care by emphasizing major strategies for improving care:

· Conduct business through partnerships within CMS, across other Federal and State agencies, and nongovernmental entities;

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

· Promote payment adjustments and incentives that express a commitment to quality healthcare and reward improved healthcare outcomes and processes, and does not inadvertently lead to negative unintended consequences.

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

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

· Promote the integration of cross-setting measurement development that takes into consideration patient outcomes across the continuum of care and develop outcome-based measures that can be applied across settings including when a particular measure pertains to a specific setting;

· Implement HHS/CMS’s quality measurement strategic approach, aligning with the over-arching three aims, NQS goals, and priorities;

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

2.A. - Basic Requirements: tc "A.

Basic Requirements " \l 3 The Measure & Instrument Development and Support (MIDS) Contractor shall:

1. Furnish the necessary services and qualified personnel, facilities, equipment, materials, and supplies not otherwise provided by the government as needed to perform the requirements set forth in this Statement of Work (SOW) and indicated in each individual Task Order.

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 umbrella statement of work and future Task Orders in accordance with applicable federal laws, regulations, and manuals, as well as the Federal Managers’ Financial Integrity Act (FMFIA), Government Auditing Standards (GAS), Federal Acquisition Regulations (FAR), the Chief Financial Officer (CFO) Act of 1990, and other legal authority as may be identified herein.

4. Continuously evaluate the effectiveness of all actions.

5. Report in accordance with the deliverables stated in Attachment A and in any future Task Order as applicable.

2.B. - Fundamental Activities:

The MIDS Contractor shall avoid duplication of effort and resources and perform activities as specified in subsequent task orders in a manner that maximizes resources and produces the most effective and efficient results.

Development, revision, and/or maintenance of assessment instrument data items, data collection vehicles, and quality measures (and their corresponding manuals, public outreach and coordination of data elements and measures with other MIDS contractors) comprise the fundamental activities of future Task Orders 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 Task Orders performed by MIDS contractors may require quality measurement program support activities such as public reporting and analytical support. These types of Task Orders, if needed, will not require all the processes, deliverables, and tools described in The Blueprint for the CMS Measures Management System (the Blueprint), 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, and such data elements may be deployed in the multiple assessment instruments, which may also serve as data collection vehicles, as data element updates. These assessment instruments, e.g., data collection vehicles or standardized data item sets, could include, but are not limited to: the Long-term Care Hospital (LTCH) Continuity Assessment Record (CARE) Data Set; the Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI); the Outcome and Assessment Information Set (OASIS); the Minimum Data Set (MDS), and the Continuity Assessment Record and Evaluation (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 such data elements in any setting requiring the submission of a standardized data for quality measurement.

Finally, the National Quality Strategy recommends a patient-centered approach to improving the quality of care in our country. In order to truly drive improvements in patient outcomes and experience with the healthcare system, CMS and other must design performance measures that address the needs and desires 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 umbrella SOW, all task orders for measure development shall include explicit incorporation of the patient perspective 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 SOW will require participation by actual patients and caregivers, not just the organizations who represent them.

2.C. – Coordination: tc "C.

Coordination " \l 3 Broadly, CMS builds its measure development and maintenance work on the three NQS aims of better quality of care, better health, and lower costs, and six 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.

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 should anticipate CMS’ requirement for 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 Quality Forum (NQF)-convened Measures Application Partnership (MAP) and National Priorities Partnership (NPP).

The MIDS contractor must integrate into the work the fundamental alignment with project timeline-related requirements, such as time lines related to the pre-rule-making process required under Section 3014 of the Affordable Care Act (ACA), rule making, 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, when appropriate, 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 Measures Management System, and overseen through a separate contracting vehicle, this system is 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 Measures Management System is to provide critical information to the measure developers to help them produce high caliber quality measures that are appropriate for accountability purposes. The Measures Management System 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 Measures Management System set of business processes and decision criteria are documented in or described in the Blueprint.

The Blueprint, divided into two volumes, is updated annually by the Measures Manager, given the evolving nature of the quality measurement environment. The first volume, Measure Development, documents the various processes necessary to plan, develop, test, and roll out a measure. The second volume, Measure Maintenance, documents the processes for production, monitoring, and maintaining a measure over time. The Measures Management Contractor will provide consultation regarding the application of the Blueprint. CMS may direct the MIDS Contractor to work collaboratively with the Measures Management Contractor to integrate the processes detailed in the Blueprint into the activities as specified in future Task Orders. The MIDS Contractor shall work with their Contracting Officer Representative (COR)/Government Task Leader (GTL) and the Measures Management Contractor to ensure they are working in accordance with 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.

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

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

2.D. - 508 Compliance:

(a) This task order is subject to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by the workforce Investment Act of 1998 (P.L. 105-220). Specifically, subsection 508(a)(1) requires that when the Federal Government procures Electronic and Information Technology (EIT), the EIT must allow Federal employees and individuals of the public with disabilities comparable access to and use of information and data that is provided to Federal employees and individuals of the public without disabilities.

(b) The EIT accessibility standards at 36 CFR Part 1194 were developed by the Architectural and Transportation Barriers Compliance Board ("Access Board") and apply to contracts and task/delivery orders, awarded under indefinite quantity contracts on or after June 25, 2001.

(c) Each Electronic and Information Technology (EIT) product or service furnished under this contract shall comply with the Electronic and Information Technology Accessibility Standards (36 CFR 1194), as specified in the contract, as a minimum. The Contractor shall, without charge to the Government, repair or replace any non-compliant products or services within the period of time to be specified by the Government in writing.

(d) The contractor must ensure that all EIT products that are less than fully compliant with the accessibility standards are provided pursuant to extensive market research and are the most current compliant products or services available to satisfy the contract requirements.

(e) For every EIT product or service accepted under this contact by the Government that does not comply with 36 CFR 1194, the contractor shall, at the discretion of the Government, make every effort to replace or upgrade it with a compliant equivalent product or service, if commercially available and cost neutral, on either a contract specified refresh cycle for the product or service, or on a contract effective option/renewal date; whichever shall occur first.

Section 508 Compliance for Communications

The Contractor shall comply with the standards, policies, and procedures below.

Rehabilitation Act, Section 508 Accessibility Standards

1. 29 U.S.C. 794d (Rehabilitation Act as amended)

2. 36 CFR 1194 (508 Standards)

3. www.access-board.gov/sec508/508standards.htm (508 standards)

4. FAR 39.2 (Section 508)

5. CMS/HHS Standards, policies and procedures (Section 508)

Regardless of format, all Web content or communications materials produced, including text, audio or video - must 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 must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents above The following Section 508 provisions apply to the content or communications material:

36 CFR Part 1194.21 a - l

36 CFR Part 1194.22 a - p

36 CFR Part 1194.31 a - f

36 CFR Part 1194.41 a – c

The following Section 508 provisions apply for software development material identified in this SOW, PWS, or TO:

For software development, the Contractor/Developer/Vendor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.21 (a – l)

36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) http://www.access-board.gov/508.htm(508 Standards)

(4) FAR 39.2 (Section 508)

(5) CMS/HHS Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/Section508/Downloads/Section508Policy.pdf For web-based applications, the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.22 (a – p)

36 CFR Part 1194.41 (a – c)

(3) http://www.access-board.gov/508.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) CMS/HHS Standards, policies and procedures (Section 508)

a. Information Technology – General Information

(http://www.cms.hhs.gov/InfoTechGenInfo/) 2.E. - Project Management:

2.E.1. - Project Management Plan:

For awarded Task Orders, the MIDS Contractor will be required to develop and submit a Project Management Plan (PMP) that defines the necessary steps (flowchart of activities), milestones, dates, deliverables, dependencies, and resources needed to execute the contract work. This may include but not be limited to the Blueprint activities for measure development, the 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 3014 of the Affordable Care Act (review by the NQF-convened Measures Application Partnership), in order to meet successful program deliverables. The Management Plan also provides constraints of the project and addresses how the MIDS Contractor proposes to perform the work described under the Task Order. 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, timeline, project milestones, critical path, and risk factors.

The MIDS contractor will specifically be responsible to identify 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 will 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, rule making, 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 MDS does not require a PRA package to be developed).

In developing the Project Management Plan, 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 development and maintenance-related work shall follow the processes specified in the Blueprint. The Contractor shall dedicate sufficient number of well-qualified staff to coordinate their contract activities with the CMS Measures Management Contractor in fulfilling all activities identified in the Blueprint.

The MIDS Contractor will provide updates to the project plan, and timelines on an established, regular basis, and as needed and will utilize the PMP to inform and ascertain critical work paths, and guide decisions related to deliverable requirements.

All project plans shall be modified and updated continuously after these initial submissions to reflect any major changes in the project. The draft Project Management Plan 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. All changes to the Project Management Plan must be reviewed and approved by the COR and GTL.

2.E.2. - Kickoff Meeting:

Under an awarded Task Order, a Kickoff Meeting shall be held no later than 30 calendar days after the Task Order award. The MIDS Contractors shall invite the Measures Management Contractor and Measures Manager COR/GTL 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 following each meeting.

2.F.- 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 draft documents and collaboration with other various agencies and CMS components.

2.G. – Ad Hoc Requests from Centers for Medicare & Medicaid Services:

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 should have graduate-level training in advanced statistical methods, and knowledge in CMS claims and/or survey data, and work experience in federally-funded national studies on topics related to health outcomes, costs, and quality.

3. Information Gathering

Under an awarded Task Order, the MIDS Contractor shall be required to gather and analyze data and information relating to activities specified in the Task Order Statement of Work 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 evaidence (or lack thereof) pertinent to the topics/condition of interest for the specifc Task Order, 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.

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

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

1. Information Gathering Report, that includes a summary report of the Environmental Scan and Empirical Data Analysis and other information

2. List of potential measures

3. Documentation on Measure Information Form (MIF) and Measure Justification Form

4. 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, the scan should identify current applicable measures that might be appropriate for the specific Task Order, through research with the following sources: employers, commercial plans, managed care plans, Tricare, NQF, MedPac, IOM, IHI (Institute for Healthcare Improvement), VHA (Veterans Health Administration), DOD (Department of Defense) and the National Priority Partnership.

In conducting the scan, consideration should also be given to the CMSQuality Measurement Task Force Goals, as well as Medicare top volume and top cost conditions. As specified in the Task Order, the contractor may be required to conduct a literature review and scan the Internet for relevant sites, papers, 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 quality measures for the purposes of developing outcome and process measures that facilitate high quality care, such as those that measure quality related to safety and adverse events, healthcare acquired conditions, such as healthcare-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, 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 quality 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 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 Statement of Work.

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

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 Task Order. 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 subject matter experts from within the Federal government agencies, e.g., the VA, CDC, DOD as well as from the public sector. The Contractor shall prepare a report describing the expert input report.

3.C. - Data Analysis:

If data is available, the Contractor may be directed to conduct an empirical data anaylysis to provide statistical or other evidence to support the selection of the topic, condition, or potential measures and to assist in the development of the business case for the topic, condition or measure. 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 identification of specific clinical topics, and quality 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 for provider accuracy in reporting.

3.D. – Summary Report:

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

· Summary Report of Environmental Scan findings

· Input from technical experts or others

· 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 Task Order, the MIDS Contractor shall include any hours/costs dedicated to pre-measure/item development that includes data analysis, literature review, etc. and/or other activities meeting the characteristics described in USOW Chapter 3 (Information Gathering) and included in the specific Task Order.

4.QUALITY MEASURE DEVELOPMENT & REEVALUATION

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

4.A. – Quality Measure Development:

Under an awarded Task Order, the MIDS Contractor shall develop Quality Measures including e-Measures based on the domains/ concepts/priorities defined in each Task Order Statement of Work. The Contractor shall utilize the Blueprint to guide measure development and maintenance. Based on the results of the information gathered, measures shall be developed which are specific and relevant to the domains/concepts/priorities described in the Task Order Statement of Work.

New Measure Development/Adaptation of Existing Measures

The following criteria should be considered during the process of new measure development/adaptation of existing measures. These criteria align with the following measure evaluation criteria, established by the Consensus Endorsement Entity (currently the NQF), the current consensus based entity under contract with the Secretary under § 1890 of Title XVIII of the Social Security Act. However, to note, contractors must reference the Measures Manager Blueprint for 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 healthcare quality, and improving health outcomes for a specific high-impact aspect of healthcare where there is variation in or overall less-than-optimal performance. Measures must be judged to meet all three subcriteria 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 the Department of Health and Human Resources (DHHS) or the National Priorities Partnership convened by the Consensus Endorsement Entity;

OR

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

AND

b. Performance Gap(demonstration of quality problems and opportunity for improvement, i.e., data2 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 supports the relationship of the 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 evidence5 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 body of evidence, quality of body of evidence, and consistency of results of 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).

· Consistency of Results of Body of Evidence: Stability in both the direction and magnitude of clinically/practically meaningful benefits and harms to patients (benefit over harms) across studies in the body of evidence

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 be judged to meet the subcriteria 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 specified7 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 the measure data elements are repeatable, producing the same results a high proportion of the time 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 support the measure’s calculation 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 meaningful15 differences in performance;

OR

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);

OR

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 electronic health records or other electronic sources. If the required data are not in electronic health records 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 healthcare 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 healthcare or credible rationale that the performance results can be used to further the goal of high quality efficient healthcare.

AND

c. Benefits of the performance measure in facilitating progress toward achieving high quality efficient healthcare 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 as to ensure the implementation of measurement alignment, and measure application, per endorsement requirements. Such alignment should 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 in accordance with the Blueprint and as specified in the Task Order. The Contractor shall consult with the Measures Management Contractor if the contractor is required to use additional criteria.

4.A.1. - Technical Expert Panels:

Under an awarded Task Order, 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 one patient or caregiver on its roster in order to provide input into quality issues that are important to patients. The contractor, will, in turn, propose the list of measures to CMS.

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

1. Convene a TEP by issuing a call for TEP on the CMS website.

2. Select a balanced panel that specifically includes patients and clinical experts that may exist outside of the provider stakeholder groups.

3. Prepare and disseminate materials for the TEP.

4. Conduct the TEP meeting via conference call, Webex or in person, and document/summarize the TEP’s review, input, discussions of the measures (Measure Evaluation Form for each measure and Summary of TEP Evaluation of measures)

5. Propose recommended set of measures to CMS 4.A.2. – Public Comment:

The public comment period specified in the Blueprint ensures that CMS measures are of the highest caliber possible by using a transparent process with balanced input from relevant stakeholders, including patients. The public comment period provides an opportunity for the widest array of interested parties to provide input on measures under development and to provide critical suggestions not previously considered by the measure contractor or the TEP.

The Example Blueprint requirements applicable to soliciting public comments include, but are not limited to:

1. Call for Public Comment (e.g., NPRM)

2. List of Stakeholders for Notification

3. Measure Information Forms and Measure Justifications for Candidate Measures

4. Verbatim Public Comments

5. Reponses to public comment (e.g., NPRM)

6. Public display of outcome of measures related to the call for Public Comment

7. Public Comment Summary Report

4.A.3. – Standardized Measure Selection Criteria:

All measures recommended for use by CMS will be reviewed against the following criteria:

1. Importance to Measure and Report

2. Scientific Acceptability of Measure Properties

3. Usability and Use

4. Feasibility

5. Harmonization

4.A.4. – Technical Specification & Documentation:

Under an awarded Task Order, the MIDS Contractor will provide complete, detailed, and precise technical specifications for all measures, standardized data item sets and data collection vehicles developed. The Contractor shall develop measures specifications consistent with the processes described in the Blueprint while mindful that the Blueprint is updated periodically to improve and streamline processes; thus, new forms and tools may be developed. The MIDS Contractor must work closely with the Measures Management Contractor to ensure they are working in accordance with most up-to-date forms and tools.

Example Blueprint requirements associated with the development of the measure technical specifications include, but are not limited to:

1. Measure Information Form - Several iterations of this form will be required as the measures are more fully specified over the course of measure development.

2. Measure Justification Form - Several iterations of this form will be required as the measures are more fully specified over the course of measure development

3. For contractors developing eMeasures, the Health Quality Measures Format (HQMF) document should be used…