FOA MACRA 102 Measure Development_050318_FINAL.PDF

U.S. Department of Health and Human Services

Centers for Medicare & Medicaid Services

Center for Clinical Standards and Quality

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity:

Measure Development for the Quality Payment Program

Amended Notice of Funding Opportunity

Cooperative Agreement

Notice of Funding Opportunity Number: CMS-1V1-18-002

CFDA: 93.986

Date: May 3, 2018

Applicable Dates:

Electronic Application Due Date: May 30, 2018 [3:00 p.m. Eastern Time]

Anticipated Issuance of Notices of Award: August 30, 2018

Anticipated Period of Performance: 12-months [September 4, 2018 to September 3, 2019]

24-months [September 4, 2018 to September 3, 2020]

36-months [September 4, 2018 to September 3, 2021]

Table of Contents

EXECUTIVE SUMMARY

A. PROGRAM DESCRIPTION

A1. Purpose

A2. Authority

A3. Background

A4. Program Requirements

A5. Technical Assistance and Information for Prospective Applicants

B. FEDERAL AWARD INFORMATION

B1. Total Funding

B2. Award Amount

B3. Anticipated Award Dates

B4. Period of Performance

B5. Funding

B6. Number of Awards

B7. Type of Award

B8. Type of Competition

C. ELIGIBILITY INFORMATION

C1. Eligible Applicants

C2. Cost Sharing or Matching

C3. Letter of Intent

C4. Ineligibility Criteria

C5. Single Application Requirements

C6. Continued Eligibility

C7. EIN, DUNS, and SAM Regulations

C8. Foreign and International Organizations

C9. Faith-Based Organizations

C10. Cover Letter

C11. Memorandum[a] of Understanding

D. APPLICATION AND SUBMISSION INFORMATION

D1. Address to Request Application Package

D2. Content and Form of Application Submission

D3. Unique Entity Identifier and System for Award Management (SAM)—Required. 27

D4. Submission Dates and Times

D5. Intergovernmental Review

D6. Funding Restrictions

D7. Mandatory Disclosure

E. APPLICATION REVIEW INFORMATION

E1. Criteria

E2. Review and Selection Process

E3. Federal Awardee Performance and Integrity Information Systems (FAPIIS) .. 37

E4. Anticipated Award Date

F. FEDERAL AWARD ADMINISTRATION INFORMATION

F1. Federal Award Notices

F2. Administrative and National Policy Requirements

F3. Terms and Conditions

F4. Cooperative Agreement Terms and Conditions of Award (Substantial Involvement) 44

F5. Reporting

G. AGENCY CONTACTS

G1. Programmatic Questions

G2. Administrative Questions

APPENDIX I: Guidance for Preparing a Budget Request and Narrative

APPENDIX II: Application and Submission Information APPENDIX III: Business Assessment of Applicant Organization (Questions) APPENDIX IV: Rehabilitation Act section 504 Compliance, Accessibility Provisions69

APPENDIX V: Application Check-Off List Required Contents

EXECUTIVE SUMMARY

This Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity:

Measure Development for the Quality Payment Program (this “Funding Opportunity”) is authorized under section 1848(s)(2) and funding is made available under section 1848(s)(6) of the Social

Security Act (the Act), as added by section 102 of MACRA (P.L. 114-10). Section 1848(s)(2) of the Act requires the Secretary to enter into contracts or other arrangements with entities, including organizations with quality measure development expertise, to develop, improve, update, or expand quality measures for application under the Merit-based Incentive Payment System (MIPS) and/or

Advanced Alternative Payment Models (APMs), which are collectively referred to as the Quality

Payment Program, in accordance with the CMS Quality Measure Development Plan, which is developed and updated as appropriate by the Secretary in accordance with section 1848(s)(1) of the

Act1. Such entities may include, but are not limited to, clinical specialty societies, clinical professional organizations, patient advocacy organizations, educational institutions, independent research organizations, health systems, and other entities engaged in quality measure development. In entering into such contracts or other arrangements, the Secretary must give priority to the development of the types of measures described in section 1848(s)(1)(D) of the Act (specifically, outcome measures2, including patient-reported outcome measures and functional status measures;

patient experience measures; care coordination measures; and measures of appropriate use of services, including measures of over use). In selecting measures for development, the Secretary must consider whether such measures would be electronically specified, as well as clinical practice guidelines to the extent that such guidelines exist. Section 1848(s)(6) of the Act authorizes $15 million for each fiscal year (FY) from 2015 through 2019, available through the end of FY 2022, to carry out section 1848(s) of the Act. Cooperative agreement awards under this Funding

Opportunity are considered an “other arrangement” for purposes of section 1848(s)(2)(A) of the

Act. Under this Funding Opportunity, up to $30,000,000 of the funding authorized by Section

1848(s)(6) of the Act has been set aside for the cooperative agreement awards over 3 years.

HHS Awarding Agency Centers for Medicare & Medicaid Services

CMS Awarding Center Center for Clinical Standards and Quality

Notice of Funding Opportunity

Title

Medicare Access and CHIP Reauthorization Act of 2015

(MACRA) Funding Opportunity: Measure Development for the Quality Payment Program

Authorization Section 1848(s)(2) and (6) of the Act, as added by section

102 of MACRA

Funding Opportunity Type New

Funding Opportunity Number CMS-1V1-18-002

Type of Award Cooperative Agreement

1 The CMS Measure Development Plan can be found at the following website: available at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.html.

2 For additional information on outcomes measures, and other types of measures, see the Measures Management

System Blueprint for definitions and additional information. Found here: https://www.cms.gov/Medicare/Quality- Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint.html https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint.html https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint.html

Catalog of Federal Domestic

Assistance

93.986

Letter of Intent to Apply Due Date

(if applicable)

N/A

Cooperative Agreement

Application Due Date & Time

May 30, 2018

3:00 p.m. Eastern time

Anticipated Issuance Notice(s) of

Award

August 30, 2018

Anticipated Period of Performance 1 year, up to 3 years, estimated start date September 4, 2018

Anticipated Total Available

Funding

Up to $30,000,000 over 3 years

Estimated Number of Awards Up to 20 Cooperative Agreements

Estimated Award Amount Per

Entity

Up to $2,000,000 per year, up to 3 years, totaling up to

$6,000,000 per recipient, subject to the availability of funds.

Estimated Award Date August 30, 2018

Eligible Applicants Entities, including organizations with quality measure development expertise. Such entities may include, but are not limited to, clinical specialty societies, clinical professional organizations, patient advocacy organizations, educational institutions, independent research organizations, health systems, and other entities engaged in quality measure development. For this Funding Opportunity, the above categories are referenced collectively as entity or entities. Entities without quality measure development technical expertise for the entire measure development lifecycle are required to partner with one or more organizations, referred to as subrecipients, with such expertise, to meet the requirements of this Funding

Opportunity.

The following types of entities are not eligible to apply for this Funding Opportunity as a primary applicant: (i) entities with active grants, cooperative agreements, and/or contracts from CMS for quality measure development, implementation, maintenance, alignment, and/or public reporting activities where CMS is the measure steward;

and (ii) entities that have Medicare deeming authority granted by

CMS denoted at : https://www.cms.gov/Medicare/Provider-

Enrollment-and-

Certification/SurveyCertificationGenInfo/Downloads/Accrediting-

Organization-Contacts-for-Prospective-Clients-.pdf.. This does not include entities only receiving funding and/or support from CMS for their measures where CMS is not the measure steward. However, all of these entities may be subrecipients on one or more applications.

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf

A. PROGRAM DESCRIPTION

A1. Purpose

The purpose of this Funding Opportunity is to provide funding assistance in the form of cooperative agreements to entities to develop, improve, update, or expand quality measures for use in the

Quality Payment Program.

Recognizing the benefits of measure development by external stakeholders with specific knowledge of clinician and patient perspectives and needs, the funding assistance of these cooperative agreements is specifically designated for entities external both to CMS and to other federal agencies. Such entities may include, but are not limited to, clinical specialty societies, clinical professional organizations, patient advocacy organizations, educational institutions, independent research organizations, health systems, and other entities engaged in quality measure development.

These external entities provide the needed medical specialty and patient perspectives to lead or support the measure development priorities of the CMS Quality Measure Development Plan and, accordingly, to advance the Quality Payment Program measure portfolio. Specifically, collaboration with and support for these entities in measure development will assist CMS in addressing such essential topics as: clinician engagement, consumer-informed decisions, critical measure gaps, quality measure alignment, and efficient data collection that minimizes health care provider burden.

The specific purpose of the individual cooperative agreements is for CMS to assist (financially and technically) each designated entity in developing, improving, updating, or expanding appropriate quality measure(s) for use in the Quality Payment Program.

A2. Authority

This Funding Opportunity is authorized under section 1848(s)(2) and funding is made available under section 1848(s)(6) of the Act. Section 1848(s)(2)(A) of the Act requires the Secretary to enter into contracts or other arrangements with entities to develop, improve, update, or expand quality measures for application under MIPS and/or Advanced APMs, which are collectively referred to as the Quality Payment Program, in accordance with the CMS Quality Measure Development Plan, which is developed and updated as appropriate by the Secretary in accordance with section

1848(s)(1) of the Act. Such entities must include organizations with quality measure development expertise. Such entities may include, but are not limited to: clinical specialty societies, clinical professional organizations, patient advocacy organizations, educational institutions, independent research organizations, health systems, and other entities engaged in quality measure development.

Section 1848(s)(2)(B)(i) of the Act requires the Secretary, in entering into such contracts or other arrangements, to give priority to the development of the types of measures described in section

1848(s)(1)(D) of the Act (specifically, outcome measures, including patient-reported outcome measures and functional status measures; patient experience measures; care coordination measures;

and measures of appropriate use of services, including measures of over use). Section

1848(s)(2)(B)(ii) of the Act requires the Secretary, in selecting measures for development, to consider (i) whether such measures would be electronically specified; and (ii) clinical practice guidelines to the extent that such guidelines exist. Section 1848(s)(6) of the Act makes available

$15 million for each of fiscal years (FYs) 2015 through 2019, available through the end of FY 2022, to carry out section 1848(s) of the Act. Of the funding authorized by Section 1848(s)(6) of the Act, up to $30,000,000 over 3 years has been set aside for the cooperative agreement awards under this

Funding Opportunity. Cooperative agreement awards under this Funding Opportunity are considered an “other arrangement” for purposes of section 1848(s)(2)(A) of the Act.

A3. Background

MACRA was enacted on April 16, 2015. Section 101(c) of MACRA requires the establishment of

MIPS, which is a new incentive payment system consolidating features of three existing clinician-based programs: the Physician Quality Reporting System (PQRS), the Physician Value-Based

Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for eligible professionals. MIPS will assess the performance of MIPS eligible clinicians in four categories: quality, cost, advancing care information, and improvement activities. Section 101(e)(2) of MACRA also creates payment incentives for physicians and other eligible clinicians to participate in Advanced APMs.

In accordance with section 101(c) and (e)(2) of MACRA, CMS created the Quality Payment

Program to improve Medicare by incentivizing clinicians to focus on quality and value of care while improving patient health. CMS strives to put patients first, ensuring that they can make decisions about their own healthcare along with their clinicians. CMS wants to ensure innovative approaches to improve quality, accessibility, and affordability while paying particular attention to improving clinicians’ and beneficiaries’ experiences when interacting with CMS programs. The Quality

Payment Program generally aims to: (1) support care improvement by focusing on better outcomes for patients, decreased clinician burden, and preservation of independent clinical practice; (2) promote adoption of APMs that align incentives for high-quality, low-cost care across healthcare stakeholders; and (3) advance existing delivery system reform efforts, including ensuring a smooth transition to a healthcare system that promotes high-value, efficient care by supporting innovative approaches to improve quality, accessibility, and affordability.

The quality measures used in MIPS and Advanced APMs serve as the mechanism for measuring quality, care delivery, and services for clinicians in the Quality Payment Program. An enhanced measure portfolio helps to ensure that clinicians can use quality measurement that is meaningful and relevant to their patients and their practice, which drives improvement toward better patient outcomes and minimizes the burden of data collection so that clinicians can spend more time with their patients.

Cooperative agreement awards under this Funding Opportunity, in accordance with section

1848(s)(2) of the Act, will be used for developing, improving, updating, or expanding quality measures for use in the Quality Payment Program in accordance with the CMS Quality Measure

Development Plan. Therefore, in accordance with section 1848(s)(1)(D) of the Act, priority for measure development will be given to the types of measures described in section 1848(s)(1)(D) of the Act, specifically:

1. Outcome measures, including patient-reported outcome and functional status measures;

2. Patient experience measures;

3. Care coordination measures; and

4. Measures of appropriate use of services, including measures of over use.

Additional considerations under the statute and specific requirements for this Funding Opportunity and the measures are explained in section A4. Program Requirements.

Within the broader context of quality measure use and development, CMS continues to engage in extensive ongoing measure development, quality reporting, and other measure-related activities. In particular, CMS contracts with measure developers to produce measures for use in CMS quality reporting and value-based payment programs. However, CMS recognizes the benefits of measure development by external stakeholders with quality measure development expertise, such as clinical specialty societies, clinical professional organizations, patient advocacy organizations, educational institutions, independent research organizations, health systems, and other entities engaged in quality measure development, and is therefore providing this Funding Opportunity.

CMS measures work is guided by the Meaningful Measurement framework3. CMS has also been engaged with commercial payers, clinician specialty societies, consumers, health care providers, and others in efforts to align quality measures across payers in order to further enhance improvement in outcomes for patients and to minimize burden for clinicians. Through the Core Quality Measures

Collaborative (CQMC), CMS and America’s Health Insurance Plans (AHIP) have collaborated with other entities to develop consensus around core sets of measures with the following three aims:

Recognize high-value, high-impact, evidence-based measures that promote better patient health outcomes, and provide useful information for quality improvement, decision-making, and payment.

Minimize the burden of measurement and volume of measures by eliminating low-value metrics, redundancies, and inconsistencies in measure specifications and quality measure reporting requirements across payers.

Refine, align and harmonize measures across payers to achieve congruence in the measures being used for payment and other accountability purposes.

CMS will continue to collaborate with commercial payers, consumers, health care providers, and others to achieve these aims through its ongoing measure-development work.

Finally, CMS utilizes scientific measure development principles throughout the entire measure-development lifecycle, which consists of the following phases: conceptualization; specification;

testing; implementation; and use, evaluation, and maintenance. CMS measure development also follows a core set of business processes and decision criteria which are outlined in the CMS

Measures Management System Blueprint (the Blueprint)4.

For certain measures, CMS uses the Measures Under Consideration (MUC) List and the Measure

Applications Partnership (MAP) processes. The MUC List is a publicly available list of quality and efficiency measures that CMS is considering adopting for use in Medicare programs. The MAP, 3 Meaningful Measures website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-

Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html 4 Blueprint available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-

Blueprint.html.

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint.html https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint.html consisting of multiple stakeholder groups, provides recommendations to CMS regarding the selection of the measures on the MUC list for use in various CMS quality reporting and value-based payment programs.

A4. Program Requirements

This Funding Opportunity requires active quality measure development work based on measure concepts or measures (that is, developing, improving, updating, or expanding quality measures) for inclusion in MIPS and/or Advanced APMs in accordance with section 1848(s)(2) of the Act. As an output of this Funding Opportunity, recipients (i.e., applicants who are awarded a cooperative agreement) will produce one or more fully developed, specified, and tested quality measures for potential use in the Quality Payment Program. Technical expertise in the full measure development lifecycle from measure conceptualization through implementation is required. Entities without quality measure development technical expertise for the entire measure development lifecycle are required to partner with one or more organizations, referred to as subrecipients, with such expertise, to meet the requirements of this Funding Opportunity. If the primary applicant has quality measure development technical expertise for the entire measure development lifecycle, the entity is not required to partner with a subrecipient. If the primary applicant is using a subrecipient, the primary applicant must submit a Memorandum of Understanding (MOU) in accordance with section C11.

and follow the requirements outlined in section D2. Content and Form of Application Submission, j.

Memorandum of Understanding, section E1.6. Criteria, Memorandum of Understanding, and section F3. Terms and Conditions.

The entire measure-development lifecycle is fully described in the Blueprint. Additionally, a recipient will obtain significant clinician and patient input. CMS will provide targeted technical assistance in the form of guidance and direction to aid recipients in their work as a part of the cooperative agreement. See Section F.4, Cooperative Agreement Terms and Conditions of Award

(Substantial Involvement) for more information.

For this Funding Opportunity there must be, at a minimum, an existing measure concept based on evidence of a demonstrated quality gap, variation in performance across clinicians, and opportunity for improvement. However, with regard to the starting point for the individual entity work, there is flexibility. For example, assistance may be available to those entities who are currently working at later stages of measure development such as testing. This Funding Opportunity also allows for associated or concordant flexibility in the amount and/or duration of assistance. For example, an entity working at later stages of measure development may apply to receive assistance for one budget period, rather than three budget periods. For more information regarding the flexibility in amount and/or duration of assistance, please refer to Section B. Federal Award Information.

For this Funding Opportunity, measure development work should align with the priorities identified in the CMS Quality Measure Development Plan. Specifically, as stated above, the measure development work must give priority to the development of the following types of measures:

1. Outcome measures including patient reported outcome and functional status measures;

2. Patient experience measures;

3. Care coordination measures; and

4. Measures of appropriate use of services, including measures of overuse.

In certain circumstances, when the measure fulfills an important need or gap area, CMS may, in accordance with the CMS Quality Measure Development Plan, consider assistance for other measure types (e.g., clinical process) if the scientific evidence-base strongly links the process to a desired outcome and if there is demonstrable variation in performance (i.e., a quality gap). CMS must also consider whether measures would be electronically specified and consider the pertinent clinical practice guidelines, to the extent that such guidelines exist.

The CMS Quality Measure Development Plan identifies initial priority areas for measure development and gap areas. These priority areas (domains) are: Clinical Care, Safety, Care

Coordination, Patient and Caregiver Experience, Population Health and Prevention, and Affordable

Care. The gap areas include, but are not limited to: Orthopedic Surgery, Pathology, Radiology, Mental Health and substance use conditions, Oncology, Palliative Care, and Emergency Medicine.

However, for this Funding Opportunity, CMS will accept applications for development of other quality measures (such as specialty/subspecialty) that fill an existing gap or need and are high impact. For example, an application may include measures for medical conditions or procedures that span an entire episode of care. For further information on initial priority areas for measure development and gap areas, see the CMS Quality Measure Development Plan: Environmental Scan and Gap Analysis Report5. Regardless of the specialty/subspecialty, the proposed measure(s) for this Funding Opportunity should both advance and align with existing measures associated with that specialty/sub-specialty. Further, CMS is seeking measures that meet the following criteria:

Fill a performance gap where there is known variation in performance, not just a measure gap, and align with the domains prioritized by MACRA and the CMS Quality Measure

Development Plan;

Focus primarily on clinical outcomes, including but not limited to patient reported outcomes and functional status measures;

Are applicable across settings and health care providers (i.e., cross-cutting);

Are patient-centered and important to patients, caregivers, and health care providers;

Are developed with the engagement of external stakeholders, including front-line practicing clinicians and patients to increase use, usability, and value while also minimizing burden;

Prioritize electronic data sources (e.g., EHRs, registries);

Minimize burden by application across delivery systems, and payers;

Maintain a focus on iterative testing using both synthetic and real data; and

Define outcomes, risk factors, cohorts, and inclusion/exclusion criteria based on clinical and empirical evidence.

This Funding Opportunity requires technical measure development infrastructure and expertise, or partnering with a subrecipient with quality measure development technical expertise, for the entire measure development lifecycle to complete measure development and produce a measure(s) ready for application under the Quality Payment Program. For example, access to complete, timely, and

5 The CMS Quality Measure Development Plan: Environmental Scan and Gap Analysis Report can be found here:

https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.html accurate data and the ability to test a measure, analyze, interpret, and present testing results is required. This Funding Opportunity requires that measures be developed under generally accepted measure development and scientific principles in order for the measures to meet the following technical requirements:

Impact, Opportunity, Evidence, Importance to Measure and Report

Reliability and Validity

Feasibility

Usability and Use

Harmonization

Stakeholder Engagement

The measure’s readiness for application under the Quality Payment Program should be interpreted, at a minimum, as having completed the requirements for a fully developed and tested measure and for consensus-based entity endorsement through the National Quality Forum (NQF). While NQF endorsement of the measure(s) is not mandatory, it is a key step in the measure development process, and the measure(s) should meet all of the requirements for endorsement. The measure’s readiness for application under the Quality Payment Program should also be interpreted as meeting the requirements for submission to the MUC List, participation in the MAP, submission to a peer-review journal, and measure stewardship, as these are also key steps in the measure development process.

Additionally, for this Funding Opportunity, measures should also meet the following basic measure-development principles:

Measures should address a performance gap where there is known variation in performance, not just a measure gap, and there has been quantitative evidence of opportunities for improvement.

Rigorous development of the business case for an evidence-based measure concept is a critical first step in the development cycle.

Patient/caregiver input is equally important to clinician input in the development of measures.

Measures should be developed in a rapid-cycle fashion, employing single-piece flow where appropriate.

Measure developers are encouraged to collaborate with other developers, and share best practices/new learnings.

Meaningful quality measures increasingly need to transition away from setting-specific, narrow snapshots.

Reorient and align measures around patient-centered outcomes that span across settings – this may require different “versions” of the same measure (i.e., different cohorts, but same definition of the numerator).

Develop measures meaningful to patients/caregivers and health care providers, focusing on outcomes.

Enable monitoring and tracking of disparities and unintended consequences.

A5. Technical Assistance and Information for Prospective Applicants

CMS will conduct pre-application conference calls that will be open to all prospective eligible applicants. During these calls, CMS will provide an overview of the cooperative agreement application process, discuss the Funding Opportunity, and answer questions from prospective eligible applicants. Additional information, including Frequently Asked Questions, will be made available on the program’s website6.

B. FEDERAL AWARD INFORMATION

This Funding Opportunity is focused on engaging stakeholders in measure development. CMS will award up to $30,000,000 for three years in funding for cooperative agreements under this Funding

Opportunity. The goal of these awards is to engage with experts in the development of measures

(such as specialty-specific outcome measures) for use in the Quality Payment Program. This

Funding Opportunity requires applicants without measure development expertise to partner with other entities with demonstrated measure development expertise to qualify for this Funding

Opportunity. The awards will range from $0- $2,000,000 a year. The awards will last 1 to 3 years and the purpose of the cooperative agreements will be to develop one or more quality measures suitable for application under the Quality Payment Program. Applicants may apply for 1 to 3 years of funding depending on measure development status and the number of measures in their application. See Section C: Eligibility Information for additional details.

This Funding Opportunity allows for a range in the amount and duration of assistance to provide applicants with adequate flexibility to allow for maximum diversity in measures and provide a

Funding Opportunity that is accessible to the greatest number of eligible entities possible. CMS anticipates that applications will vary greatly in the number of measures proposed, the complexity of the measure(s) developed, and phase(s) of measure development that the proposed measure(s) has completed. The Blueprint details the measure development lifecycle and a sample timeframe for the measure development phases to use as guidance. CMS recognizes, and anticipates, that the level and length of assistance will vary based on the number of measures proposed, the complexity of the measure(s) developed, and phase(s) of measure development that the proposed measure(s) has completed. Here is a list of some of the factors that will contribute to variation in the amount and duration of each award:

Starting point: While it is a Funding Opportunity program requirement that the applicant have an evidence-based measure concept, some applicants may be further along in specification or testing than others. An applicant proposing measure concepts that need to be fully specified may request more resources over a longer period of time under this

Funding Opportunity than a measure that is ready or in the middle of the measure-testing phase. Alternatively, if the applicant is proposing to update an existing quality measure, the applicant may request less time and funding.

6 Medicare Access and CHIP Reauthorization Act of 2015 (MACRA): Measure Development for the Quality Payment

Program website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based- Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html

Number of measures: An applicant proposing to develop multiple measures or a coordinated measure set may request more resources over a longer duration than an applicant proposing to develop a single measure.

Complexity of the measure(s): The complexity of the measure(s) proposed in an application will contribute to variations in amount and duration of award. The length and complexity of the measure testing phase is likely to reflect the complexity of the measure to ensure the measure’s reliability, feasibility, validity, and usability. The type, scope, and data source of the measure impact the measure’s complexity.

o Type (e.g., outcome, process, patient reported outcome) o Scope (e.g., single setting, cross-setting, across specialties) o Data source (e.g., electronic health records, registries, claims)

Endorsement: Endorsement by a consensus-based entity, currently the National Quality

Forum (NQF), provides critical stakeholder feedback and is a valuable step in the measure development process (see Blueprint for more information). The attainment of NQF endorsement is strongly encouraged and applicants are able to use this Funding Opportunity to support the process of obtaining NQF endorsement; it is not a requirement of this Funding

Opportunity. An applicant’s choice of whether to include NQF endorsement in their proposal will have an impact on the amount and duration of award.

Each applicant should consider the factors outlined above when: (1) requesting funding under this

Funding Opportunity; and (2) proposing a period of performance (1 year, 2 years, or 3 years). Please note that as part of the review and selection process, CMS will evaluate both the funding and period of performance requested. As a result of these evaluations, CMS may require that the funding or the period of performance requested by the applicant be altered by a potential awardee during the pre-award Negotiations phase of the award process, if such Negotiations are conducted. The applicant has the burden of explaining why the requested funding and period of performance are justified. If the requested funding or period of performance is determined by CMS to be excessive, then the applicant must agree to reduce either or both, as applicable. CMS will not award more funds than are requested by the applicant.

B1. Total Funding

The total amount of federal funds available for all recipients is up to $30,000,000 for 3 years, subject to the availability of funds.

B2. Award Amount

The award amount available per recipient is up to $2,000,000 per year for up to 3 years, for a total of up to $6,000,000 per recipient, subject to the availability of funds.

B3. Anticipated Award Dates

The anticipated award date is 90 days after the application due date.

B4. Period of Performance

The project period for each Cooperative Agreement award will be up to 36 months from the date of award. Multi-year awards will be comprised of 12-month budget periods. See section B5. Funding for more information.

B5. Funding Applicants may receive a multi-year award. The project period will either be 12 months, 24 months, or

36 months, funded in 12-month increments known as “budget periods.” Although initial funding awarded through this Funding Opportunity will cover only the first 12-month budget period of a 24- or

36-month project period, the applicant must still submit an estimated budget for each of the budget periods (year 1 and, as applicable year 2 and year 3). Please see Appendix I, Guidance for Preparing a

Budget Request and Narrative, for specific instructions. The following shows an example of the project and budget periods for one-, two-, and three-year awards.

Estimated One-Year Award

Project Period: September 4, 2018 to September 3, 2019 Up to $2,000,000 (total)

Budget Period One: September 4, 2018 to September 3, 2019 Up to $2,000,000

Estimated Two-Year Award

Project Period: September 4, 2018 to September 3, 2020 Up to $4,000,000 (total)

Budget Period One: September 4, 2018 to September 3, 2019 Up to $2,000,000

Budget Period Two: September 4, 2019 to September 3, 2020 Up to $2,000,000

Estimated Three-Year Award

Project Period: September 4, 2018 to September 3, 2021 Up to $6,000,000 (total)

Budget Period One: September 4, 2018 to September 3, 2019 Up to $2,000,000

Budget Period Two: September 4, 2019 to September 3, 2020 Up to $2,000,000

Budget Period Three: September 4, 2020 to September 3, 2021 Up to $2,000,000

Future funding will be issued through non-competing continuation awards for years 2 and 3. Non-competing continuation awards are contingent upon available funds, satisfactory performance during the previous budget period(s), and the recipient’s ability to continue meeting all requirements laid out in the

Funding Opportunity and the terms and conditions of award. A non-competing continuation application is a financial assistance request (in the form of an application or performance/progress report) for a subsequent budget period within a previously approved project period for which a recipient does not have to compete with other applicants. The process for applying and receiving a non-competing continuation award will be outlined in the terms and conditions of award. Satisfactory performance during the previous budget period(s) will be measured by assessing: (1) the recipient’s ability to meet the performance metrics laid out in their original application; (2) the quality and timeliness of report submissions; (3) the recipient’s compliance with the terms and conditions provided with their Notice of

Award, including compliance with all applicable statutory and regulatory requirements; and (4) the recipient’s ability to communicate with and respond in a timely manner to requests from the CMS project officer throughout the project period.

B6. Number of Awards

The anticipated number of cooperative agreement awards is up to 20.

B7. Type of Award

These awards will be structured as Cooperative Agreements. The Federal Grant and Cooperative

Agreement Act of 1977, 31 U.S.C. § 6301, et seq., defines the cooperative agreement as an alternative assistance instrument to be used in lieu of a grant whenever substantial Federal involvement with the recipient during performance is anticipated. The difference between grants and cooperative agreements is the degree of Federal programmatic involvement rather than the type of administrative requirements imposed (see F4. Cooperative Agreement Terms and Conditions of

Award (Substantial Involvement)). Therefore, statutes, regulations, policies, and the information contained in the HHS Grants Policy Statement that are applicable to grants also apply to cooperative agreements, unless the award itself provides otherwise.

B8. Type of Competition

This will be a competitive Funding Opportunity.

C. ELIGIBILITY INFORMATION

C1. Eligible Applicants

This Funding Opportunity is open to entities, which must include organizations with quality measure development expertise, such as clinical specialty societies, clinical professional organizations, patient advocacy organizations, educational institutions, independent research organizations, health systems, and other entities engaged in quality measure development.

Eligible applicants should have quality measure development technical expertise for the entire measure development lifecycle. Entities without quality measure development technical expertise for the entire measure development lifecycle are required to partner with an organization(s), referred to as a subrecipient, with that expertise to meet eligibility requirements. If the entity submitting the application has quality measure development technical expertise, the entity is not required to partner with an organization since the primary applicant meets the eligibility requirement. Each applicant must submit a Cover Letter which affirms that it is an entity with quality measure development technical expertise or, if not, that it has partnered with one or more organizations with quality measure development expertise for the entire measure development lifecycle. To signify this partnership, eligible applicants are required to submit a Memorandum of Understanding for each subrecipient to meet Funding Opportunity requirements. See D2. Content and Form of Application

Submission, d. Cover Letter and j. Memorandum of Understanding for additional information.

See also the explanation included in D2.Content and Form of Application Submission, a.

Application Format, regarding CMS’s evaluation of ineligible, incomplete, and/or non-responsive applications.

C2. Cost Sharing or Matching

Cost sharing or matching is not a requirement of this Funding Opportunity.

C3. Letter of Intent

Submission of a letter of intent is not a requirement of this Funding Opportunity.

C4. Ineligibility Criteria

The following types of entities are not eligible to apply for this Funding Opportunity as a primary applicant: (i) entities with active grants, cooperative agreements, and/or contracts from CMS for quality measure development, implementation, maintenance, alignment, and/or public reporting activities where CMS is the measure steward; and (ii) entities that have Medicare deeming authority granted by CMS denoted at : https://www.cms.gov/Medicare/Provider-Enrollment-and-

Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-

.pdf.. Applicants must attest they do not meet either of these exclusion criteria in the Cover Letter.

See section D2. Content and Form of Application Submission, d. Cover Letter for more information. This does not include entities only receiving funding and/or support from CMS for their measures where CMS is not the measure steward. However, all of these entities may be subrecipients on one or more applications.

C5. Single Application Requirements

An entity may submit only one application under this Funding Opportunity. However, an entity may be a subrecipient on multiple applications.

C6. Continued Eligibility

Award recipients must meet reporting and certification deadlines to be eligible throughout the initial

12-month budget period and to remain eligible for a non-competing continuation award for subsequent budget periods in multi-year projects. In addition, recipients would need to demonstrate strong performance during the previous funding cycle(s) before additional year funding is awarded;

or, in the case of awards where all funding is issued in the first year, to ensure continued access to funding. At any time in the award cycle, recipients could receive decreased funding or their cooperative agreement could be terminated if recipients fail to perform the requirements of the award.

C7. EIN, DUNS, and SAM Regulations

In order to apply, all applicants are required to have a valid Employer Identification Number (EIN), otherwise known as a Taxpayer Identification Number (TIN); a Dun and Bradstreet (D & B) Data

Universal Numbering System (DUNS) number; and be registered in the System for Award

Management (SAM) database (copy and paste the following into a browser, (https://www.sam.gov/portal/SAM/##11) to be able to submit an application at http://www.grants.gov. See Appendix II, Application and Submission Information, for descriptions of EIN, DUNS, and SAM.

C8. Foreign and International Organizations

Foreign and international organizations are not eligible to apply.

C9. Faith-Based Organizations

Faith-based organizations are eligible to apply.

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf https://www.sam.gov/portal/SAM/ http://www.grants.gov/

C10. Cover Letter

Applicant must include a Cover Letter (on organizational letterhead), which provides assurances (1) that the applicant is an organization with quality measure development technical expertise to include

(in brief) supporting information; or (2) that the applicant is an organization without quality measure development technical expertise but has partnered with one or more organization(s), referred to as subrecipient(s), with that expertise to meet the eligibility requirement related to quality measure development technical expertise. As described in C.11, each such partnership must be documented via a Memorandum of Understanding. The Cover Letter must further attest that the applicant (1) is not an entity with an active grant, cooperative agreement, and/or contract from CMS for quality measure development, implementation, maintenance, alignment, and/or public reporting activities where CMS is the measure steward; and (2) is not an entity that has Medicare deeming authority granted by CMS denoted at : https://www.cms.gov/Medicare/Provider-Enrollment-and-

Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-

.pdf.. The Cover Letter must be signed by the Authorized Organizational Representative identified on the SF-424 (Application for Federal Assistance). See also D2. Content and Form of Application

Submission d. Cover Letter.

C11. Memorandum[a] of Understanding

Entities without quality measure development technical expertise are required to partner with one or more organization(s), referred to as subrecipients, with that expertise to meet eligibility requirements of the Funding Opportunity related to quality measure development technical expertise. A Memorandum of Understanding (MOU) must be provided for each subrecipient that aids the primary applicant in meeting this eligibility requirement. See D2. Content and Form of

Application Submission, j. Memorandum of Understanding for additional information. If awarded a cooperative agreement, a recipient will be required to provide to CMS copies of updated MOUs with each subrecipient, as applicable, to document any post-award changes required. The MOU must document each subrecipient’s acknowledgement and commitment to complying with cooperative agreement requirements under this Funding Opportunity.

D. APPLICATION AND SUBMISSION INFORMATION

D1. Address to Request Application Package

Application materials will be available at http://www.grants.gov. Please note that HHS requires applications for all announcements to be submitted electronically through Grants.gov. Applicants will be able to download a copy of the application packet, complete it off-line, and then upload and submit the application via the Grants.gov website. Refer to Appendix II, Application and

Submission Information, for specific instructions on how to apply.

D2. Content and Form of Application Submission

The sub-headers a. through j. included in this section align with the evaluation criteria outlined in

Section E1. The evaluation criteria and scoring of the application will be based upon the information and documents requested in these sub-headers.

a. Application Format https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-Contacts-for-Prospective-Clients-.pdf

Applications determined to be ineligible, incomplete, and/or nonresponsive based on the initial screening may be eliminated from further review. However, the Centers for Medicare &

Medicaid Services Office of Acquisition and Grants Management Grants Management Officer

(CMS/OAGM/GMO), in its sole discretion, may continue the review process for an ineligible application if it is in the best interests of the government to meet the objectives of this Funding

Opportunity.

Each application must include all contents described below, in the order indicated, and conform to the following specifications:

The following page size must be used: 8.5” x 11” letter-size pages (one side only) with 1” margins (top, bottom, and sides). Other paper sizes will not be accepted. This is particularly important because it is often not possible to reproduce copies in a size other than 8.5” x 11”.

All pages of the project, budget narratives, and implementation plan must be paginated in a single sequence.

Font size must be at least 12-point with an average of 14 characters per inch (CPI).

The Project Narrative must be double-spaced. The page limit for this document is 50 pages.

The Implementation Plan must be double-spaced. The page limit for this plan is 20 pages.

The Budget Narrative may be single-spaced and should follow the justifications and table formats provided in Appendix I, Guidance for Preparing a Budget Request and Narrative.

The page limit for this document is 20 pages.

The Business Assessment of Applicant Organization may be single or double-spaced. The page limit for this document is 10 pages.

Tables included within any portion of the application should have a font size of at least 12-point with a 14 CPI and may be single spaced. Tables are counted towards the applicable page limits.

The project abstract is restricted to a one-page summary which may be single-spaced.

The…