Attachment J.1-Statement of Work_Amendment 0001.pdf

Attachment J.1 Statement of Work October 4, 2022

National Consensus Development and Strategic Planning for Health Care Quality Measurement

Statement of Work (SOW)

CHAPTER 1. SCOPE

1.A. Background

The Centers for Medicare & Medicaid Services (CMS) is the federal agency tasked with overseeing a variety of health care programs, including Medicare, Medicaid, and the Health Insurance Marketplace. The agency strives to ensure that the American public receives the highest quality of care, based on evidence about the benefits and costs applicable to each individual patient, and supported by measure development and performance measurement.

Section 183 of the Medicare Improvement for Patients and Providers Act (MIPPA) of 2008 established Section 1890 of the Social Security Act (i.e., the Act), which requires the Secretary of the Department of Health and Human Services (HHS) (i.e., the Secretary) to contract with a consensus-based entity (CBE) to accomplish various duties pertaining to health care performance measurement, including, (1) establishing a priority setting process for measure development, (2) endorsing and maintaining measures, (3) convening key stakeholders to make recommendations, and (4) submitting a report to Congress on an annual basis.

Since the enactment of MIPPA, work conducted by a CBE has been funded by various statutes to ensure that the Centers for Medicare & Medicaid Services (CMS) continuously assess priorities, supports advancements, and leads efforts in health care performance measurement. CBE work conducted with statutory funds must address at least one (1) of the duties of the CBE listed in Section 1890 or 1890A of the Social Security Act.

The MIPPA of 2008 can be found at: https://www.govinfo.gov/content/pkg/PLAW- 110publ275/pdf/PLAW-110publ275.pdf

1.B. Purpose

The purpose of this contract is to procure the services of a CBE, necessary to support various duties pertaining to health care performance measurement, as required under Section 1890 of the Act. These duties include:

1. Convene key stakeholders to synthesize evidence and submit recommendations on an integrated national strategy and priorities for health care performance measurement, in accordance with Section 1890(b)(1) of the Act;

2. Establish and conduct consensus-based endorsement processes and expedited review processes of health care performance measures, in accordance with Sections 1890(b)(2) of the Act;

3. Establish and implement consensus-based maintenance and ad hoc review processes to ensure measures endorsed by the CBE are updated or retired as new evidence is developed, in accordance with Section 1890(b)(3) of the Act;

4. Produce and submit Annual Reports to Congress and the Secretary, in accordance with

Section 1890(b)(5)(A) of the Act; and

5. Convene multi-stakeholder groups for input on national priorities and the selection of quality https://www.govinfo.gov/content/pkg/PLAW-110publ275/pdf/PLAW-110publ275.pdf https://www.govinfo.gov/content/pkg/PLAW-110publ275/pdf/PLAW-110publ275.pdf measures for a pre-rulemaking process, which is required by Social Security Act Sections 1890(b)(7) and 1890A.

1.C. General Duties to be Performed in Support of National Consensus Development and Strategic Planning for Health Care Quality Measurement

In accordance with Section 1890(b)(1) of the Act, the contractor shall synthesize evidence and convene key stakeholders to make recommendations on an integrated national strategy and national priorities for health care performance measurement in all applicable settings.

Specifically, in their work under the subject contract, the contractor shall:

1. Ensure that priority is given to measures:

a. That address the health care provided to patients with prevalent, high-cost chronic diseases;

b. With the greatest potential for improving the quality, efficiency, and patient-centeredness of health care;

c. That may be implemented rapidly due to existing evidence, standards of care, or other reasons; [and

d. That align with CMS priorities.]

2. Consider measures that:

a. May assist consumers and patients in making informed health care decisions;

b. Address health disparities across groups and areas; and

c. Address the continuum of care a patient receives, including services furnished by multiple health care providers or practitioners and across multiple settings;

3. Endorse measures;

4. Maintain measures;

5. Submit an Annual Report to Congress and the Secretary;

6. Convene multi-stakeholder groups; and

7. Transmit multi-stakeholder input.

CHAPTER 2. GENERAL CONTRACT REQUIREMENTS

The contractor shall meet the voluntary consensus standards requirements under Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), – P.L. 104-113, the Office of Management and Budget (OMB) Revised Circular A- 119, and other criteria described in this

Statement of Work.

The contractor shall ensure that work is performed in a manner that ensures public transparency.

To ensure fairness and transparency, all documented agreements to be signed with and/or by a measure developer and/or measure steward shall be uniform in terms. An Agreement Template (Deliverable 2-1) shall be submitted for Government approval. Any updates to the Agreement Template, including any negotiated changes to the uniform terms contained within the Agreement Template, shall not be implemented until the COR and/or CMS Task Lead has provided approval.

All deliverables and/or work products, including without limitation, all developed processes, documents, and materials (e.g., agreements between the contractor and measure developers and/or stewards, measure review criteria, presentations, technical guidance, specifications, etc.) under this contract shall be and remain the exclusive property of HHS/CMS without restriction upon their use.

2.A. Mandatory Requirements

The contractor shall meet and maintain the following mandatory requirements, in accordance with Section 1890(c) of the Social Security Act:

1. The [contractor] is a private non-profit entity governed by a board.

2. The members of the board of the [contractor] include:

a. Representatives of health plans and health care providers and practitioners, or representatives of groups representing such health plans and health care providers and practitioners;

b. Health care consumers, or representatives of groups representing health care consumers;

and

c. Representatives of purchasers and employers, or representatives of groups representing purchasers or employers.

3. The membership of the [contractor] includes persons who have experience with:

a. Urban health care issues;

b. Safety net health care issues;

c. Rural and frontier health care issues;

d. Health care quality and efficiency and safety issues; [and

e. The science of quality measurement, including patient reported outcomes and digital quality measures (dQMs).]

4. With respect to all matters related to [the contract], the [contractor] conducts business in an https://www.lawinsider.com/clause/ownership-of-materials open and transparent manner and provides the opportunity for public comment on its activities.

5. The [contractor] operates as a voluntary consensus standard setting organization as defined for purposes of [S]ection 12(d) of the National Technology Transfer and Advancement Act of 1995 (Public Law 104-113) and Office of Management and Budget Revised Circular A-119 (published in the Federal Register on February 10, 1998).

6. The [contractor] has at least four (4) years of experience in establishing national consensus standards.

7. If the [contractor] requires a membership fee for participation in the functions of the [CBE], such fees shall be reasonable and adjusted based on the capacity of the potential member to pay the fee. In no case shall membership fees pose a barrier to the participation of individuals or groups with low or nominal resources in the functions of the [CBE].

In addition to the requirements of Section 1890(c) of the Social Security Act, the contractor’s ability to perform work under this contract shall not pose a conflict of interest, either actual or potential, with any other duties and activities the contractor may conduct. A conflict of interest will be deemed to exist if an activity impacts the contractor’s ability to conduct neutral consensus-based processes. In the event that such a conflict of interest exists, the contractor shall promptly disclose to CMS the material facts related to the conflict of interest, including specific information relating to the terms and conditions of this contract.

2.B. Coordination and Project Management

The contractor shall submit a Project Management Plan that addresses all project management activities associated with the performance of this contract. A Draft Project Management Plan (Deliverable 2-2) shall be submitted for Government comment. The contractor shall incorporate Government comments into a Final Project Management Plan (Deliverable 2-3). The Project Management Plan shall be updated throughout the contract period of performance. These updates shall be completed at the frequency necessary to accommodate changes to the content detailed within the document, including any decisions made or guidance provided during the Kick Off Meeting (described below). The Project Management Plan shall include the following:

1. Timeline: The contractor shall develop a timeline for all anticipated contract milestones and due dates to be addressed under the contract. The timeline shall account for all relevant issues and tasks involved in meeting the contract requirements. In collaboration with the Contracting Officer’s Representative (COR) and/or CMS Task Lead, the contractor shall also provide specific due dates for all deliverables listed within the Schedule of Deliverables as “In accordance with the Project Management Plan”.

2. Communication Plan: The contractor shall develop a Communication Plan to aid in the performance of the work required under this contract. The Communication Plan shall identify the staff assigned to perform work under this contract, their role(s) under this contract, and their contact information.

3. Risk Management Strategy: The contractor shall develop a Risk Management Strategy that will identify, evaluate, and analyze risks related to the performance of this contract.

Specifically, the contractor should address risks that could impact the deliverable timeline, deliverable quality, costs, etc. The Risk Management Strategy shall include the following information:

a. Process: The contractor shall ensure that risks are actively identified, analyzed, and managed throughout the life of the contract. Risks will be identified as early as possible in the contract period of performance, so as to minimize their impact.

b. Risk Identification: The contractor shall work with the (1) COR and/or CMS Task Lead,

(2) contract team, and/or (3) appropriate stakeholders to identify risks associated with the performance of this contract. In identifying risks, careful attention should be given to contract deliverables, assumptions, constraints, work breakdown structure, cost and/or effort estimates, resource plans, and other key contract documents. The contractor shall also develop a Risk Management Log.

c. Risk Analysis: The contractor shall work with the COR and/or CMS Task Lead to assess all risks that have been identified, in order to determine potential performance outcomes resulting from these risks.

d. Risk Response Planning: The contractor shall work with the COR and/or CMS Task Lead to assign each major risk to a contract team member. This assigned team member shall be responsible for making sure that the risk does not “fall through the cracks”.

e. Risk Monitoring, Controlling, and Reporting: The contractor shall work with the COR and/or CMS Task Lead to ensure that the level of risk on the contract is tracked, monitored, and reported throughout the contract period of performance.

4. Additional Information: The contractor shall incorporate additional information into the

Project Management Plan, as requested by the COR and/or CMS Task Lead.

The contractor shall host a Kick Off Meeting (Deliverable 2-4), including the COR, CMS Task Lead, and applicable CMS staff. The purpose of the meeting will be to identify and clarify issues relating to the work to be performed under the contract. The contractor shall present the key aspects of their Final Project Management Plan, as described above, during the Kick Off Meeting.

Additionally, the contractor shall present the CMS-Developed Measures Communication Plan, detailed below within Chapter 3.B.6. of the Statement of Work, during the Kick Off Meeting. In consultation with the COR and/or CMS Task Lead, the contractor shall prepare all Pre-Kick Off Meeting Materials (Deliverable 2-5), including the agenda and any necessary handouts for the Kick Off Meeting. The contractor is also responsible for providing Kick Off Meeting Minutes (Deliverable 2-6), following the Kick Off Meeting.

The contractor shall submit a Monthly Status Report (Deliverable 2-7), detailing the prior month’s activities. Specifically, the Monthly Status Report shall include the following:

1. A list of all deliverables submitted within the prior month, including the date submitted and the deliverable status (e.g., “Approved by CMS” or “Awaiting Government Comments”);

2. A summary of meetings, areas of focus, and planned activities for the upcoming month;

3. A status tracker of each measure submitted for endorsement and maintenance (E&M) review under the contract, including the identification of any CMS programs under which each measure is implemented (e.g., Hospital Readmissions Reduction Program);

4. A status tracker of any ongoing ad hoc projects or tasks;

5. A list of risks and/or issues of concern that require CMS action, including the priority of each item identified;

6. A summary of any unresolved risks and/or issues from the prior month; and

7. Additional information, as requested by the COR and/or CMS Task Lead.

The Monthly Status Report shall also include an appendix, in which the contractor shall provide an Incurred Cost Report for the activities performed during the subject month, and cumulatively throughout the contract period of performance. The contractor shall organize the Incurred Cost Report by major task (i.e., Statement of Work Chapter) and sub-task within the contract. The Incurred Cost Report shall incorporate appropriate visuals, and compare progress and resource expenditures to the estimated schedule and budget initially proposed by the contractor. The contractor shall provide an explanation for any variances, and describe any significant changes in the contractor's operational resources and/or personnel.

The contractor shall host Status Meetings (Deliverable 2-8), including the COR, CMS Task Lead, and applicable CMS staff, to review current activities under the contract for each of the following areas:

1. Consensus-Based Endorsement and Maintenance of Health Care Performance Measures;

2. Multi-Stakeholder Input on the Selection and Removal of Quality and Efficiency Measures in

CMS Programs; and

3. Core Quality Measures Collaborative (CQMC).

Status Meeting participants shall be limited to necessary contractor and CMS staff, as determined by the agenda items for the given meeting. Relevant developments to, and current utilization of, the Project Management Plan shall be a standing agenda item for the Status Meetings. Prior to the meeting, the contractor shall prepare all Pre-Status Meeting Materials (Deliverable 2-9), including an agenda and any necessary handouts. Following the meeting, the contractor shall provide Status Meeting Minutes (Deliverable 2-10), detailing the events of the Status Meeting. Meeting minutes shall include the following:

1. Actions items; and

2. Decisions made and/or plans developed.

The contractor is also responsible for providing ad hoc informal communications (e.g., email communications) with CMS, as needed to provide essential updates between meetings.

The contractor shall prepare a Meeting Summary (Deliverable 2-11) for any multi-stakeholder group meetings, including virtual meetings, webinars, education meetings, review meetings, strategic meetings, and conference calls in which multi-stakeholder groups discuss measures reviewed for E&M, pre-rulemaking, or measure set review under this contract, unless otherwise specified within this Statement of Work. The Meeting Summary shall document the purpose of the meeting, measures discussed, and any decisions made or recommendations provided within the meeting. The contractor is not required to submit a Meeting Summary for preparation meetings.

The contractor shall submit an Annual Report to Congress and the Secretary of HHS. Section 1890 of the Act requires the CBE to provide an Annual Report to Congress and the Secretary of HHS on activities identified in Section 1890(b)(5)(A). The contractor shall submit a Courtesy Copy Annual Report (Deliverable 2-12), in compliance with all requirements stated in Section 1890(b)(5)(A) of the Act, prior to the submission of the Final Annual Report (Deliverable 2-13). In accordance with Section 1890(b)(5)(A) of the Act, the Annual Report shall include the following:

1. A description of the implementation of quality and efficiency measurement initiatives undertaken by the CBE under this contract, and the coordination of such initiatives with quality and efficiency initiatives implemented by other payers;

2. Recommendations made to HHS, with respect to HHS’ integrated national strategy and priorities for health care performance measurement;

3. A description of the CBE’s performance of the duties required under the contract;

4. Identified gaps in endorsed quality and efficiency measures, including measures within priority areas identified by the Secretary under the national strategy. The report shall also include the identification of areas in which quality and efficiency measures are unavailable or inadequate to identify or address such gaps;

5. Identified areas in which evidence is insufficient to support endorsement of quality and efficiency measures in priority areas identified by the Secretary under the national strategy.

The report shall also include the identification of areas in which targeted research may address such gaps;

6. A summary of input received from multi-stakeholder groups on the following:

a. The selection of certain quality and efficiency measures; and

b. National priorities related to improvement in population health and the delivery of health care services, for consideration under the national strategy.

7. An itemization of financial information for the fiscal year ending September 30th of the preceding year, including:

a. Annual revenues of the entity, including any Government funding, private sector contributions, grants, membership revenue, and investment revenue;

b. Annual expenses of the entity, including grants funded, benefits provided, salaries and/or other compensation, fundraising expenses, and overhead costs; and

c. A breakdown of the amount awarded [(i.e., initially proposed by the contractor)] per contracted task [(i.e., Statement of Work Chapter)] and the specific projects funded for each task.

8. A description of any updates or modifications to the entity’s internal policies and procedures, as they relate to the duties of the entity under this [contract], including:

a. The identification of any updates or modifications to the disclosure process for interests and conflicts of interests for committees, work groups, task forces, and advisory panels of the entity. The report shall also include descriptions of any relevant interests and conflicts of interest among members of all committees, work groups, task forces, and advisory panels; and

b. The identification of any updates or modifications to external stakeholder participation in the duties of the entity under this [contract]. The report shall include complete rosters for all committees, work groups, task forces, and advisory panels funded through [this contract]. Additionally, the report shall include the total percentage by health care sector of all convened committees, work groups, task forces, and advisory panels.

The contractor shall notify CMS, measure developers, measure stewards, the public, and other stakeholders of any proposed changes in E&M, pre-rulemaking, and measure set review processes under this contract. The notifications should include the following information:

1. The method for submitting public comments;

2. The due date for public comment submission;

3. A description of how the submitted comments will be considered; and

4. A description of when and how the final decisions will be announced.

Any process changes must be vetted and approved by stakeholders and CMS before changes can be made official.

The contractor is responsible for developing Public Facing Website(s) (Deliverable 2-14) in support of contract activities. The Public Facing Website(s) shall be property of the Government and maintained by the contractor. The Public Facing Website(s) shall be developed under a Cloud environment, in accordance with the CMS Cloud Computing Requirements (CMS-CLD). The contractor shall employ a Human Centered Design (HCD) approach with a user functionality focus in the development of any websites and/or webpages. The Public Facing Website(s) shall be developed and updated throughout the contract period of performance. These developments and updates shall be completed at the frequency necessary to accommodate changes to the content detailed within the website(s) and to support any ongoing actions under the subject contract. All website content and design elements require review and approval by the COR and/or CMS Task Lead.

The contractor is responsible for ensuring that all written materials submitted for public dissemination are written in plain language, professionally edited (e.g., proper grammar, no spelling errors, consistent formatting, etc.), and compliant with Section 508 standards.

2.C. Stakeholder Engagement Requirements

For purposes of this contract, the term “stakeholder” is defined as an individual meeting at least one of the following criteria:

1. Patients, caregivers, or patient advocates;

2. Providers, including primary care providers, specialists, accountable care organizations, hospitals or hospital systems, post-acute/long-term care facilities;

3. Purchasers (State, Federal, and/or Private);

4. Researchers in health services financing, alternative payment models (e.g., bundled payment, shared savings, gain-sharing, all-payer models, etc.), population health, or measure methodology; and

5. Other relevant stakeholders, as determined to be appropriate by the COR, and/or the CMS

Task Lead.

The contractor shall ensure that at least three (3) patients and/or patient representatives participate in each stakeholder group.

Any contractor staff utilized to facilitate multi-stakeholder group meetings, voluntary consensus stakeholder group meetings, webinars, and/or conference calls shall have at least one (1) year of experience facilitating meetings of similar sizes and topics. The contractor shall facilitate stakeholder group meetings to reach consensus.

The contractor is responsible for selecting multi-stakeholder representation and convening multi-stakeholder group meetings and/or webinars to provide input on specified topic areas. In accordance with Section 1890 (b)(7)(D) of the Act, “multi-stakeholder group” means, a voluntary collaborative of organizations representing a broad group of stakeholders interested in or affected by the use of quality and efficiency measures.

When convening stakeholders for measure review, the contractor should consider the potential need for a specific measure to undergo an expedited review, as expedited reviews often call for measure reviewers with highly specialized training and clinical knowledge. Specifically, the contractor should consider appeals factors, patient safety concerns, and/or other public health or policy imperatives.

The contractor shall propose and implement processes to facilitate expedited measure reviews that are open, transparent, informed, and fair.

The contractor shall develop, compile, and update Multi-Stakeholder Group & Voluntary Consensus Stakeholder Group Education Materials (Deliverable 2-15) for the various multi-stakeholder groups and voluntary consensus stakeholder groups that provide feedback, input, and/or recommendations for measurement use, endorsement, and/or frameworks. These Multi-Stakeholder Group & Voluntary Consensus Stakeholder Group Education Materials may include presentation slide decks, Frequently Asked Questions (FAQs), methodology briefs, measure submission forms, etc. Multi-Stakeholder Group & Voluntary Consensus Stakeholder Group Education Materials shall be provided to members of the multi-stakeholder groups and voluntary consensus stakeholder groups in advance of upcoming meetings. Multi-Stakeholder Group & Voluntary Consensus Stakeholder Group Education Materials shall also be provided to the COR and/or CMS Task Lead. Multi-Stakeholder Group & Voluntary Consensus Stakeholder Group Education Materials shall detail the processes relevant to the multi-stakeholder groups and voluntary consensus stakeholder groups and be developed for use by both seasoned and novice stakeholders. When appropriate, and approved by the COR and/or CMS Task Lead, the contractor shall also send the Multi-Stakeholder Group & Voluntary Consensus Stakeholder Group Education Materials to measure developers and measure stewards for reference.

The contractor shall develop Recommendations, Guidance, and Findings Reports (Deliverable 2-16), based on the input of multi-stakeholder groups related to an integrated national strategy and national priorities for health care performance measurement in all applicable settings.

Additionally, the contractor shall convene stakeholders to provide input on the following, to be included in the Annual Report detailed above within Chapter 2.B. of the Statement of Work:

1. Identifying gaps in endorsed quality and efficiency measures, including measures within priority areas identified by the Secretary under the national strategy;

2. Identifying areas in which quality and efficiency measures are unavailable or inadequate to identify or address gaps in endorsed quality and efficiency measures;

3. Identifying areas in which evidence is insufficient to support endorsement of quality and efficiency measures in priority areas identified by the Secretary under the national strategies;

4. Identifying areas in which targeted research may address such gaps.

The contractor shall ensure that the meetings detailed in the above paragraph solely focus on identifying the gap areas detailed above, and do not involve discussions on approaches to address gap areas or measure development.

The contractor shall solicit stakeholders and stakeholder organizations from outside of the contractor’s own organization, for activities involving the public. These activities include, but are not limited to, the calls for nomination and the announcements of public comment periods.

2.D. Health Care Ad Hoc Tasks

The contractor shall establish and implement ad hoc consensus-based processes and convene multi-stakeholder groups for one (1) to two (2) Health Care Ad Hoc Tasks (Deliverable 2-17) per contract period (e.g., Base Period, Option Period 1, etc.).

The topic(s) for Health Care Ad Hoc Tasks shall be determined by CMS. These topics are expected to be related to performance measurement and HHS/CMS priorities. Generally, Health Care Ad Hoc Tasks will be prompted by unforeseeable circumstances related to:

1. Performance measurement frameworks;

2. Performance measurement reports;

3. Performance measure and electronic clinical quality measure (eCQM) reviews and guidance;

4. Review of program policies and structure, as it relates to quality and efficiency measures within the program;

5. HHS initiatives and public and private partnerships regarding performance measurement;

and/or

6. CMS and national priorities surrounding performance measurement (e.g., the National

Quality Strategy, alignment, digital measures, patient engagement, and/or new developments on best practices).

Health Care Ad Hoc Tasks shall be requested at the discretion of COR and/or CMS Task Lead.

Examples of Health Care Ad Hoc Tasks include, but are not limited to:

1. Developing trend reports for measure exclusions;

2. Assessments of measure implementation and impact;

3. Identifying and analyzing unintended consequences related to performance measurement;

4. Drafting reports directly related to quality and efficiency measures endorsed and maintained under this contract; and

5. Providing data related to quality and effciency measures maintained under this contract to other CMS contractors.

Specific details regarding Health Care Ad Hoc Tasks (e.g., task descriptions, timelines, etc.) will be provided by the COR and/or CMS Task Lead during the course of the contract, as needed. Each task description will include a list of activities and deliverables to be completed, deliverable due dates, and the timeframe for overall task completion.

The contractor will be required to provide a level of effort estimate for approval by the COR and/or CMS Task Lead before performing any Health Care Ad Hoc Tasks.

The contractor shall provide Outreach, Education, and Dissemination of Ad Hoc Materials (Deliverable 2-18) to stakeholders, the public, State Medicaid Agencies, CMS, and other HHS agencies. Ad Hoc Materials shall be publicly disseminated or posted, as directed by the COR and/or CMS Task Lead.

Deliverables in Chapter 2:

Deliverable 2-1 Agreement Template Deliverable 2-2 Draft Project Management Plan Deliverable 2-3 Final Project Management Plan Deliverable 2-4 Kick Off Meeting Deliverable 2-5 Pre-Kick Off Meeting Materials Deliverable 2-6 Kick Off Meeting Minutes Deliverable 2-7 Monthly Status Report Deliverable 2-8 Status Meetings

Deliverable 2-9 Pre-Status Meeting Materials Deliverable 2-10 Status Meeting Minutes Deliverable 2-11 Meeting Summary Deliverable 2-12 Courtesy Copy Annual Report Deliverable 2-13 Final Annual Report Deliverable 2-14 Public Facing Website(s) Deliverable 2-15 Multi-Stakeholder Group & Voluntary Consensus Stakeholder Group Education Materials Deliverable 2-16 Recommendations, Guidance, and Findings Reports Deliverable 2-17 Health Care Ad Hoc Tasks Deliverable 2-18 Outreach, Education, and Dissemination of Ad Hoc Materials

CHAPTER 3. CONSENSUS-BASED ENDORSEMENT AND MAINTENANCE OF HEALTH

CARE PERFORMANCE MEASURES

Among the duties identified in Section 1890 of the Act is the requirement for the contractor to establish, implement, and provide consensus-based processes for the E&M of health care performance measures. Section 207 of the Medicare Access and Children’s Health Insurance Program (CHIP) Re-authorization Act (MACRA) of 2015 authorizes the extension of funding for quality measure endorsement, input, and selection. CMS utilizes the consensus-based E&M process to ensure the selection of reliable, valid, and high-priority performance measures.

In accordance with Section 1890(b)(2) of the Act, the contractor shall provide an endorsement process for standardized health care performance measures. The endorsement process shall consider whether a measure is:

1. Evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, and responsive to variations in patient characteristics (e.g., health status, language capabilities, race or ethnicity, and income level);

2. Consistent across different types of health care providers, including hospitals and physicians.

In accordance with Section 1890(b)(3) of the Act, the contractor shall establish and implement a process to ensure that measures endorsed by the CBE are updated, or retired if obsolete, as new evidence is developed.

3.A. General Requirements and Standard Operations

The contractor shall conduct a consensus-based E&M process for performance measures that meet the Section 1890 of the Act, the National Technology Transfer and Advancement Act (NTTAA) of 1995, and OMB Circular A-119 requirements for a voluntary consensus stakeholder group and process. The contractor shall conduct consensus-based E&M activities for both CMS and non-CMS funded measures. As the funding source for this contract, CMS will oversee the contractor’s activities regardless of a measure’s purpose, developer, funding source, or other characteristics.

The contractor shall provide an open and transparent process, in accordance with the Act. The contractor should consider an E&M process that is collaborative, practical, agile, consistent, unbiased, and efficient. The E&M process should not be cost prohibitive or overly burdensome for measure developers.

The contractor shall provide measure developers and/or submitters with the opportunity to fully address any questions from multi-stakeholder groups involved in the E&M process. In doing so, the contractor shall provide prompt notification of any questions from multi-stakeholder groups to developers and/or submitters, affording them with reasonable time to prepare additional analyses requested by these multi-stakeholder groups. Reasonable timelines for these actions shall be determined by the COR and/or CMS Task Lead.

In accordance with the notification process detailed above in Chapter 2.B. of the Statement of Work, the contractor shall send written notifications to the public, CMS, other HHS agencies, and other stakeholders, providing them with the opportunity to comment on performance measures and processes.

Upon receiving stakeholder comments, the contractor shall provide prompt notification of these comments and their contents to measure developers and measure stewards, including CMS and other HHS agencies. The contractor shall also provide measure developers and measure stewards with the opportunity to prepare a response to these comments and the opportunity for the voluntary consensus stakeholder group to review and deliberate on the response before moving forward in the E&M process.

All conduct of consensus-based activities related to the E&M process, including meetings, workgroups, and gatherings shall occur within a virtual setting. When potentially controversial measures and/or topic areas are discussed, the contractor shall provide meeting transcripts to CMS, upon the request of the COR and/or CMS Task Lead.

The contractor shall share any technical guidance provided to measure stewards and/or developers during measure submissions with voluntary consensus stakeholder group members. If specific measure submission requirements have been exempted for a given measure, the contractor should share the background, rationale, and technical details of the exemption(s) with the voluntary consensus stakeholder group members who review the measure, prior to measure review discussions.

Voluntary consensus stakeholder group members should be provided with adequate time to understand the rationale and nature of such exemptions.

The contractor shall establish rules of engagement for meetings with the voluntary consensus stakeholder group. The rules of engagement should address the number of members permitted to participate, quorum, voting process(es), etc. Votes on measures should not be held when quorum is not met at the start of the meeting during attendance check. Exceptions shall not be made to this standard, even if quorum is achieved later in the meeting.

The contractor shall implement appeal proceedings for E&M decisions. Voting outcomes shall be relayed to measure developers and/or stewards expeditiously, to allow maximum time to prepare for any appeals, if needed. The contractor shall provide written notification of the decisions of the appellate/voluntary consensus stakeholder group responsible for adjudicating appeals to CMS, measure developers, and measure stewards.

The contractor shall ensure that all E&M standards are continuously applied, from the time that the call for measures is made public until the entire process is complete (e.g., through the end of appeal proceedings). If any changes in the E&M process or measure evaluation criteria are implemented during the period of performance of this contract, the implemented changes shall not be applied to any measure that is under current review within the E&M process.

All finalized drafts for public facing documents (e.g., meeting materials, including presentations, agendas, and summaries) shall be submitted to the COR and/or CMS Task Lead for clearance review at least twenty days prior to their anticipated public release.

3.B. Endorsement and Maintenance Requirements

3.B.1. Endorsement and Maintenance Process Proposal

The contractor shall submit an Endorsement and Maintenance Process Proposal (Deliverable 3-1) for implementation of innovative approaches to E&M under this contract. These approaches should increase flexibility for measure submission and limit the length of E&M review of measures to no more than six (6) calendar months, without compromising the quality of the decisions or increasing the cost of submission. The Endorsement and Maintenance Process Proposal should include:

1. A detailed discussion on the options for E&M approaches;

2. A description of the benefits and risks for each option;

3. A summary of why the proposed approach is superior to the alternatives presented;

4. A summary of how the risks for the proposed approach can be mitigated; and

5. Empirical evidence to support the proposal contents, if available.

The contractor is responsible for implementing their Endorsement and Maintenance Process Proposal, upon approval by CMS.

The contractor is responsible for notifying CMS, measure developers, measure stewards, the public, and other stakeholders of any proposed changes in the E&M process under this contract.

Changes include, but are not limited to, the following:

1. Changes to the entity that makes the recommendation and/or final decision for measure endorsement and/or re-endorsement;

2. Changes to the entity that adjudicates appeals against endorsement decisions;

3. Changes to the length of maintenance and periodic review cycles;

4. Changes to measure endorsement status;

5. Changes to criteria for attaining specific endorsement status; and

6. Changes to the procedure(s) for requesting reconsideration on endorsement recommendations or decisions.

The COR and/or CMS Task Lead should be updated on the progress of the vetting and/or reviewing proposed process changes, during the Status Meetings detailed above in Chapter 2.B.

of the Statement of Work. Any changes to the E&M process, including those listed above, shall not be implemented until the COR and/or CMS Task Lead has provided approval.

3.B.2. Endorsement and Maintenance Projects

The contractor is responsible for conducting E&M projects under this contract. The term “project” refers to a set of measures grouped based on similarities. The number of measures per project will vary, dependent on the need for measure reviews, as determined by the COR and/or CMS Task Lead. The E&M projects should target any measure(s) that may fall within at least one of the following categories:

1. Clinical Topics (e.g., diabetes care, surgical adverse events, reproductive health, infectious diseases, etc.);

2. Topics Related to the Care Delivery Process (e.g., care coordination, admissions/readmissions, equity, etc.);

3. Topics Related to a Specific Segment of the Population (e.g., patients with dual eligibility, Medicaid recipients, pediatric patients, marginalized populations, etc.); and/or

4. Topics Addressing Broad Public Health Issues (e.g., population health, patient-centered care, health and well-being, etc.)

The contractor shall submit an Endorsement and Maintenance Project Proposal (Deliverable 3-2) covering the entire contract period of performance (i.e., Base Period through Option Period 4).

The proposal shall include the following information:

1. The proposed number of E&M projects to be conducted over of the entire contract period of performance;

2. The proposed topic for each E&M project;

3. The proposed standard operating procedures for each E&M project, detailing how the contractor will complete each E&M project;

4. The proposed number and length, in hours, of virtual meetings and/or conference calls with the project’s voluntary consensus stakeholder group(s);

5. The timeline, including the start and end dates, of each E&M project; and

6. The mechanism(s) proposed to facilitate emergency measure reviews.

Upon CMS approval of the Endorsement and Maintenance Project Proposal, the contractor shall begin to implement their proposed E&M projects, in accordance with the approved Endorsement and Maintenance Project Proposal. The Endorsement and Maintenance Project Proposal shall be updated throughout the contract period of performance. These updates shall be completed at the frequency necessary to accommodate changes to the content detailed within the document. Any changes to the Endorsement and Maintenance Project Proposal, including those that would impact the volume of measures to be reviewed, shall not be implemented until the COR and/or CMS Task Lead has provided approval.

Each E&M project shall last no more than six (6) months from the time that the call for measures is made public until the end of the project (e.g., through the end of appeal proceedings). For each E&M project, the contractor shall convene no more than twenty-five (25) stakeholders within the project’s designated multi-stakeholder group.

3.B.3. Endorsement and Maintenance Project Reports

The contractor shall produce a Project Report for each E&M project, upon completion. Each Project Report shall include the following information:

1. The E&M project title;

2. An executive summary, limited to a maximum of two (2) pages;

3. A summary of the scope of review conducted under the E&M project;

4. A list of the performance measures submitted and evaluated under the E&M project;

5. A list of the performance measures endorsed and not recommended for endorsement under the E&M project;

6. A list of measure concepts submitted during the solicitation process for measures under the E&M project;

7. A summary of the public comments received during the E&M process for the E&M project;

8. A summary of any potential high-priority gap areas for measure developers to consider for future development, identified during the E&M project; and

9. A summary of any major concerns or methodological issues raised during performance measure evaluation of the E&M project.

A Draft Project Report (Deliverable 3-3) shall be submitted for Government review, upon completion of each E&M project. Draft Project Reports should be professionally edited and prepared for public dissemination. A Final Project Report (Deliverable 3-4), incorporating any necessary revisions indicated during the Government’s review, shall also be submitted for each E&M project.

3.B.4. Measures

The contractor is responsible for accommodating the submission of the following measure categories, in order to increase the flexibility of measure submissions:

1. Measures at varying levels of analysis, (e.g., measures developed and tested at the population, facility, plan, accountable care organization (ACO), and individual clinician levels);

2. dQMs;

3. Patient reported outcomes performance measures (PRO-PMs); and

4. Measures developed to fulfill specific statutory requirements (e.g., the Improving

Medicare Post-Acute Care Transformation Act of 2014).

The contractor shall prioritize all HHS/CMS developed measures, and measures that fall within CMS programs.

3.B.5. Stakeholders

The contractor is responsible for convening stakeholders for E&M. Stakeholder outreach and engagement efforts shall be incorporated into all E&M activities involving the public, including calls for nomination and the announcement of public comment periods.

The contractor shall ensure that all voices are heard and voluntary consensus stakeholder group recommendations are representative of the diverse stakeholders comprising the voluntary consensus stakeholder groups. The contractor should ensure a balance of viewpoints during discussions, by providing each stakeholder with comparable amounts of time to articulate their viewpoints and assuring that no group member(s) dominate the discussion at the expense of the engagement of other members.

The contractor shall convene stakeholders with the expertise necessary to review performance health care measures for each E&M project. Due to the potentially broad arrangement of measure topics, the contractor should leverage the experience of (1) individuals who have participated in previous or ongoing CBE activities and/or (2) individuals with measure development or implementation experience in specific areas, in the review of various types of performance measures.

The contractor shall ensure that there is a turnover of one third (1/3) of voluntary consensus group members per year, to ensure that new perspectives are continually added to multi-stakeholder groups.

3.B.6. Communication

The contractor shall develop a CMS-Developed Measures Communication Plan (Deliverable 3- 5). The CMS-Developed Measures Communication Plan shall establish the contractor’s approach to keeping the measure developers, CMS measure lead(s), COR, and/or CMS Task Lead updated on the status of the CMS-developed measures during the E&M process. For each CMS-developed measure under review, the contractor shall share the materials for review with the CMS measure lead(s), COR and/or CMS Task Lead, and the voluntary consensus stakeholder group.

The contractor is responsible for implementing the CMS-Developed Measures Communication Plan, upon approval by CMS.

3.C. Education and Outreach

3.C.1. Technical Assistance, Education Materials, Webinars, and Workshops

The contractor shall provide technical assistance and education for measure developers submitting and updating health care measures for the consensus-based E&M process under Chapter 3 of the Statement of Work. This assistance may include, but is not limited to, coordination with developers, responding to questions, and providing guidance on the E&M process. The contractor shall also assist developers with coordinating submission, if similar or competing measures are submitted for the consensus-based E&M process.

The contractor shall develop a Simplified Informational Document (Deliverable 3-6) for measure submitters, which details the E&M process. The various steps of the E&M process should be detailed within the Simplified Informational Document, including each phased review, possible outcomes, appeal proceedings, etc.

The contractor shall develop and update additional Endorsement and Maintenance Education Materials (Deliverable 3-7) to support the E&M process and projects. Endorsement and Maintenance Education Materials should provide easily accessible information for CMS/HHS staff or CMS/HHS-funded measure developers with limited experience. The primary target audience for Endorsement and Maintenance Education Materials includes CMS/HHS measure leads, CMS/HHS-funded measure developers, and members of voluntary consensus stakeholder groups for the E&M projects. The Endorsement and Maintenance Education Materials should support the above referenced staff in learning key concepts related to measure development and the E&M process. Endorsement and Maintenance Education Materials may also be made available to the public, upon approval of the COR and/or CMS Task Lead. CMS and other HHS agencies may suggest topics for Endorsement and Maintenance Education Materials throughout the contract period of performance. Education materials may include presentation slide decks, FAQs, guidebooks, video- or audio- recordings, etc. All Endorsement and Maintenance Education Materials shall be compliant with Section 508 standards.

All Endorsement and Maintenance Education Materials shall be updated throughout the contract period of performance, to reflect any changes to the E&M process, requirements for E&M reviews, and/or legislation or regulations that may impact measure E&M. These updates shall be completed at the frequency necessary to accommodate changes to the content detailed within the materials.

The contractor shall plan, coordinate and host Quarterly Educational Webinars (Deliverable 3-8) to support the E&M process and projects. The purpose of these Quarterly Educational Webinars is to inform and educate measure developers and stewards, CMS/HHS measure leads, members of the voluntary consensus stakeholder groups, and members of the public with interest in quality measurement. The Quarterly Educational Webinars must focus on topics related to quality measurement, the E&M process, or other areas requested by the COR and/or CMS Task Lead.

The contractor shall obtain approval from the COR and/or Task Lead for each topic of discussion on the Quarterly Educational Webinars. Following each Quarterly Educational Webinar, the contractor should publicly post all presentation materials and/or recordings on the Public Facing

Website(s), as detailed above is Chapter 2.B. of the Statement of Work. Links to the postings shall be shared with the COR and/or CMS Task Lead.

The contractor shall conduct one (1) Measure Developer Workshop (Deliverable 3-9) per contract period (e.g., Base Period, Option Period 1, etc.). The Measure Developer Workshop shall focus on relevant topics for measure developers regarding quality measurement development.

The contractor shall obtain COR and/or CMS Task Lead approval for the topic(s) covered within the Measure Developer Workshops.

3.C.2. Quarterly Debriefings on the Endorsement and Maintenance Process

The contractor shall plan, coordinate, and host Quarterly Conference Calls (Deliverable 3-10) with the COR and/or CMS Task Lead, HHS/CMS-funded measure developers, and HHS/CMS measure leads who work with the developers.