PKG00262806-instructions.pdf

DEPARTMENT OF

HEALTH AND HUMAN SERVICES

OFFICE OF THE

ASSISTANT SECRETARY FOR HEALTH

Office of Minority Health

Funding Opportunity: Demonstration to Increase Hydroxyurea Prescribing for Children with Sickle Cell Disease Through Provider Incentives

Opportunity Number: MP-CPI-20-002

Application Due Date:

Thursday August 27, 2020 6:00 PM Eastern

OVERVIEW

FEDERAL AGENCY NAME

Office of the Assistant Secretary for Health and the Office of Minority Health

FUNDING OPPORTUNITY TITLE

Demonstration to Increase Hydroxyurea Prescribing for Children with Sickle Cell Disease

Through Provider Incentives

ACTION

Notice

ANNOUNCEMENT TYPE

Initial Competitive Grant

FUNDING OPPORTUNITY NUMBER

MP-CPI-20-002

CFDA NUMBER AND PROGRAM:

93.137 Community Program to Improve Minority Health

DATES

Application Deadline: Thursday August 27, 2020 by 6:00 PM Eastern.

Technical Assistance: webinar, July 31, 2020 at 2:99 PM Eastern.

EXECUTIVE SUMMARY

The Office of Minority Health (OMH) announces the availability of funds for Fiscal Year

(FY) 2020 grant awards under the authority of Section 1707 of the Public Health Service Act (42

U.S.C. § 300u-6).

This notice solicits applications to demonstrate the feasibility and effectiveness of providing financial incentives to providers to improve the quality of life of children with sickle cell disease (SCD) through increased prescription rates of hydroxyurea. This initiative is not issued or funded by the Centers for Medicare and Medicaid Services (CMS).

OMH intends projects funded under this initiative to build the capacity of State Medicaid

Offices and other partners to achieve three main goals: (1) develop performance measures for hydroxyurea prescribing for the three main provider types that care for children with SCD (i.e., hematologists, primary care providers, and emergency clinicians); (2) develop and implement an incentive payment system(s) for each provider type; and (3) evaluate the effectiveness of financial incentives for providers to increase hydroxyurea prescribing and decrease emergency department visits for children with SCD. OMH expects awarded projects to generate data and assess the impact of incentive payments on hydroxyurea prescribing behavior and the identification of best practices and lessons learned through the implementation of funded projects. OMH anticipates the availability of approximately $2,500,000 annually for this funding opportunity to support up to 2 awards ranging from $750,000 to $1,250,000 per year for up to 3 years, pending availability of funds and satisfactory performance.

This initiative is grounded in data demonstrating the effectiveness of hydroxyurea as a chronic, well-tolerated therapy that can reduce emergency visits, hospitalizations, and life-threatening complications in individuals living with SCD. Despite demonstrated efficacy, numerous studies have documented low rates of hydroxyurea utilization by children with SCD1-3 due to multiple factors, including barriers at the provider, patient/family, and system levels.4-6 To date, no published studies have assessed the effectiveness of providing financial incentives for providers to increase hydroxyurea prescribing in either children or adults living with SCD.

If the applicant is not a State Medicaid Office, the applicant is expected to secure a formal partnership with the State Medicaid Office as evidenced by a signed memorandum of agreement.

If awarded, the applicant organization will be responsible for project implementation, project management and financial oversight for the federal grant. See Section E, Eligibility Information, for the organizations that are eligible to apply for this grant. HHS/OASH encourages applicants to review all program requirements, eligibility information, application format and submission information, evaluation criteria, and other information in this funding announcement to ensure that its application complies with all requirements and instructions.

FUNDING OPPORTUNITY DETAILS

A. DATES

1. Application Deadline

Your application is due August 27, 2020 by 6 p.m. Eastern Time. To receive consideration, you must submit your application electronically via Grants.gov no later than this due date and time. If you do not submit your application by the specified deadline, we will return it to you unread. You must submit electronically via Grants.gov unless you obtain a written exemption from this requirement 2 business days in advance of the deadline from the Director, HHS/Office of the Assistant Secretary for Health (OASH) Grants and Acquisitions Management (GAM)

Division. To obtain an exemption, you must request one via email from the HHS/OASH/GAM, and provide details as to why you are technologically unable to submit electronically through

Grants.gov. Your request should be submitted at least 4 business days prior to the application deadline to ensure your request can be considered prior to 2 business days in advance of the deadline. If you request an exemption, include the following in your e-mail request: the

HHS/OASH announcement number; your organization's DUNS number; your organization’s name, address and telephone number; the name and telephone number of your Authorizing

Official; the Grants.gov Tracking Number (for example, GRANT####) assigned to your submission; and a copy of the "Rejected with Errors" notification from Grants.gov. Send the request with supporting documentation to OASH_Grants@hhs.gov. Note: failure to have an active

System for Account Management (SAM) registration prior to the application due date will not be grounds for receiving an exemption to the electronic submission requirement. As a result of the public health emergency for COVID-19, the requirement for an active SAM registration at the time of application submission has been waiveded (see Section F.4). However, if you do not have a DUNS number at this time, you should contact the Grants.gov to establish a temporary DUNS number. Your application will not be accepted through Grants.gov without this number. Failure to follow Grants.gov instructions to ensure software compatibility will not be grounds for receiving an exemption to the electronic submission requirement.

The HHS/OASH/GAM will only accept applications via alternate methods (hardcopy paper via U.S. mail or other provider or PDF via email) from applicants obtaining prior written approval. If you receive an exemption, you must still submit your application by the deadline.

Only applications submitted through the Grants.gov portal or alternate format (hardcopy paper via

U.S. mail or other service or PDF via email) with an approved written exemption will be accepted.

See Section F.8 (“Other Submission Requirements”) for information on application submission mechanisms.

Executive Order 12372 comment due date: The State Single Point of Contact (SPOC) has

60 days from the application due date to submit any comments. For more information on the SPOC see section F.6 Intergovernmental Review.

mailto:ogm.oash@hhs.gov

To ensure adequate time to submit your application successfully, HHS/OASH recommends that you register as early as possible in Grants.gov since the registration process can take up to one month. You must register an authorizing official for your organization. HHS/OASH does not determine your organization’s authorizing official; your organization makes that designation. For information on registering for Grants.gov, refer to http://www.grants.gov or contact the Grants.gov

Contact Center 24 hours a day, 7 days a week (excluding Federal holidays) at 1-800-518-4726 or support@grants.gov.

Your organization is strongly encouraged to register multiple authorized organization representatives in Grants.gov to ensure someone is available to submit your application.

2. Technical Assistance

A technical assistance webinar for potential applicants will be held on July 31, 2020. Please check the Office of Minority Health website, www.minorityhealth.hhs.gov, for more detailed information.

We recommend you review the entire announcement promptly so you can have any questions answered well in advance of the application due date. We also recommend you subscribe to this announcement in Grants.gov so you receive any amendments, question and answer documents, or other updates.

B. PROGRAM DESCRIPTION:

The Office of the Assistant Secretary for Health and the Office of Minority Health (OMH) announce the availability of funds for Fiscal Year (FY) 2020 grant awards under the authority of

Section 1707 of the Public Health Service Act (42 U.S.C. § 300u-6). OMH is dedicated to improving the health of racial and ethnic minority populations through the development of health policies and programs that will help eliminate health disparities. Through its demonstration grants, http://www.grants.gov/ mailto:support@grants.gov

OMH supports the identification of effective approaches for improving health outcomes with the ultimate goal of promoting dissemination and sustainability of these approaches. This particular grant aligns with the Assistant Secretary for Health’s priority on SCD; HHS Strategic

Goal 1: Reform, Strengthen, and Modernize the Nation’s Health Care System; HHS Strategic

Goal 2: Protect the Health of Americans Where They Live, Learn, Work, and Play; and the HHS

Secretary’s Priority on Value-Based Care.7

This OMH initiative is intended to demonstrate the feasibility and effectiveness of providing financial incentives to providers to improve the quality of life of children living with

SCD through increased prescription rates of hydroxyurea. OMH intends successful applicants to build the capacity of State Medicaid Offices and other partners to achieve three main goals:

(1) develop quality measures for hydroxyurea prescribing for the three main provider types that care for Medicaid-eligible children with SCD (i.e., hematologists, primary care providers, and emergency clinicians); (2) develop and implement an incentive payment system(s) for each provider type; and (3) evaluate the effectiveness of provider incentives to increase hydroxyurea prescribing and decrease emergency department visits for children living with SCD. For the purposes of this FOA, the age range of children can be defined by the applicant but cannot exceed

21 years, consistent with the Medicaid definition of children in for Early and Periodic Screening, Diagnostic and Treatment Services.

1. Background

SCD, estimated to affect 100,000 Americans, is the most common inherited blood disorder in the United States and primarily affects African Americans and Hispanics.8 SCD occurs among about 1 out of every 365 Black or African-American births and among about 1 out of every 16,300

Hispanic-American births.8 About 40% of individuals with SCD in the United States are children and adolescents.9 A majority of individuals with SCD are on Medicaid.10 Federal statute and regulations for the Early and Periodic Screening, Diagnostic and Treatment Services (EPSDT) benefit requires the provision of comprehensive and preventive health care services, including

SCD services, to children under age 21 who are enrolled in Medicaid.11 Over 47% of Medicaid beneficiaries with SCD are aged 18 and under.12 There are significant differences in the geographic distribution of Medicaid beneficiaries by state. New York, Florida, Georgia, Texas, California, Illinois, Louisiana and North Carolina had the largest proportion of individuals with SCD among

Medicaid beneficiaries.12 Mississippi, the District of Columbia, Louisiana, South Carolina, Georgia, Alabama and Maryland had among the highest prevalence rates of SCD per 1,000 beneficiaries.12 Over half of Medicaid beneficiaries with SCD in Nebraska, Texas, Maryland, Georgia, Arkansas, Mississippi, Tennessee, Kentucky, Louisiana, Delaware, Indiana, Florida and

Oklahoma are aged 18 and under.12

SCD is characterized by debilitating pain crises, frequent hospitalizations, and decreased life expectancy compared to the general population and can lead to life-threatening complications such as stroke and infections.13 Many severe complications of SCD, such as sepsis, stroke, and painful episodes requiring hospitalization, occur in childhood.14 Medicaid-enrolled children with

SCD were more likely to have inpatient admissions and emergency department visits than privately-insured children with SCD.15 SCD is associated with high treatment costs, averaging

$10,000 annually for children.16

These outcomes can be minimized with disease-modifying therapies, such as hydroxyurea.

Initiation of hydroxyurea among pediatric patients has been found to reduce rates of hospitalizations, pain encounters, and emergency department visits.17 Hydroxyurea treatment among children has been shown to be cost-effective and to reduce total health care costs.18 Any physician can prescribe hydroxyurea, but it is usually prescribed in conjunction with a hematologist to ensure appropriate monitoring.19 Numerous studies, however, have documented low hydroxyurea prescriptions and/or utilization for pediatric patients with SCD.1-3 A majority of individuals with SCD are on Medicaid, but only about 1 in 4 Medicaid-enrolled children with SCD received hydroxyurea.20

Increased reimbursement for providers is one intervention that can improve adherence to clinical guidelines, and thus increase access to treatment. Incentive payments provided to clinicians when performance benchmarks are met have been shown to improve care in oncology and might be effective for the SCD population. Because an estimated 50 to 60 percent of SCD patients who access care through state-based Medicaid plans, demonstration of the effectiveness of incentive payments to increase hydroxyurea prescribing in just one or a few states could serve as a powerful example for other states.

2. Expectations

OMH expects successful applicants to:

a. Develop hydroxyurea quality measures

• Convene key partners representing all three provider types (i.e., hematologists, primary care providers, and emergency clinicians) and major clinical care facilities within the state shortly after award to discuss and develop quality measure(s) to measure hydroxyurea prescribing among children with SCD. Define the candidate quality measure(s) for each provider type and develop algorithms for measuring them using administrative data, shortly after award. Algorithms should include methods for defining the SCD pediatric population eligible for hydroxyurea consistent with the 2014 National Heart, Lung, and Blood

Institute (NHLBI) guidelines.21

• Convene additional meetings with key partners to discuss pros and cons of each candidate quality measure and gain concurrence on which measures to include in the incentive payment system(s).

• Provide baseline data (OMH recommends at least 3-4 years using ICD-

10 codes and pharmacy data) for all candidate quality measures for both the control and intervention groups as specified in the Awardee’s application.

b. Develop and promote the incentive payment system(s) and develop evaluation plan

• Have Institutional Review Board (IRB) approval at or near the start of the project period and provide documentation to HHS/OASH/GAM.

• Within 6 months of the initial award, start developing incentive payment system(s) for all three provider types tailored to local contexts and priorities. Potential approaches include episode-based, shared savings, and population-based payment arrangements that incorporate meaningful quality measures. A state Medicaid agency can receive a federal grant from OMH so long as the state Medicaid agency uses the

OMH funds for non-Medicaid, quality-based incentive payments to sickle cell providers, with no change to the otherwise applicable

Medicaid service payments. The state Medicaid agency should abide by generally applicable cost allocation requirements and not use the OMH grant funds as the state share for Medicaid expenditures.

• The incentive plan system must include an appropriate oversight plan to ensure that hydroxyurea prescriptions are medically indicated for the patient. The plan should address patient safety concerns as well as potential fraud risks.

• Within 9 months of the initial award, demonstrate the ability to report high-quality quality measure data and define the anticipated start date of the implementation of the incentive payment system(s).

• Within 6 months prior to the anticipated start date of incentive payment system implementation, develop and disseminate informational materials (including notice of privacy practices) for clinicians, health-related service providers, and other prospective beneficiaries promoting the availability and time frame for the incentive payment system(s).

• Provide equitable opportunities for all provider types within the intervention group to participate in the proposed incentive payment system(s).

• Estimate potential uptake with the incentive payment system(s) and anticipated maximum and minimum payout costs during implementation.

• Finalize agreed processes and authorization/consent forms for incentive payment system participation. Awardees must adhere to all applicable

Federal, state, and local laws and ordinances, and should work with their counsel to determine what patient authorizations, if any, may be required to implement the incentive payment system(s) as designed, including with respect to information sharing required to support the incentive payment system(s).

• Within 15 months of the initial award, demonstrate an ability to operationalize and implement quality measure(s) and related incentive payment system(s).

• Within 15 months of the initial award, develop an evaluation plan that, at a minimum, will assess the impact of the incentive payment system(s) on hydroxyurea prescribing and emergency department utilization among children with SCD. Applicants are encouraged consider data for other downstream outcomes measures (e.g., hospitalizations, overall healthcare costs) in addition to emergency department visits.

• Identify and document best practices and lessons learned with input from key stakeholders before implementation of the incentive payment system(s).

• Meet OMH expectations for attendance and participation in scheduled

Project Officer calls, timely and complete submissions for quarterly progress reports, annual performance reports, and attendance at all required learning events.

c. Implement and evaluate incentive payment system(s)

• Before the end of the second year, implement the incentive payment system(s) for at least 12 months, including maintaining the infrastructure, processes, and programs established before implementation of the incentive payment system(s).

• Collect, analyze and report on quality measures quarterly and develop tools for sharing data with administrators, healthcare providers, and practice managers, in compliance with all applicable laws regarding information sharing.

• Provide incentive payments at the end of the period of performance to providers as outlined in the incentive payment system specifications.

• Work with the State Medicaid Office to collect, analyze, and summarize data as required for evaluation of the incentive payment system(s) hydroxyurea prescribing rates and emergency department visits for both control and intervention populations.

• Identify and document best practices and lessons learned

d. Disseminate project findings and results

• Document project findings and results and disseminate to State

Medicaid Offices, the population served, the general public, and other parties who might be interested in using the results of the project. OMH expects that nationwide dissemination of products and knowledge will occur.

e. Develop a sustainability plan

• Develop a sustainability plan that addresses financial, staff and supervisory, and material resources needed to sustain successful intervention of the incentive payment system(s) after the project period ends.

OMH expects successful applicants to partner with State Medicaid Offices to:

• Collect and provide data (individual- and population-level) for both the intervention and control groups

• Support the development of information sharing agreements and related infrastructure

• Align support for the incentive payment system across child-focused state agencies and organizations

• Assist in designing and implementing the incentive payment system(s)

• Establish and execute any necessary formal legal agreements between the awardee and State Medicaid Office within 12 months of the initial project start date outlining roles and responsibilities of the of each party for system implementation and evaluation

• Meet any applicable laws and requirements for implementing the incentive payment system(s)), including but not limited to requirements for information sharing in support of such incentive payment system(s),and including but not limited to requirements under statutes and regulations administered by CMS.

• As appropriate, communicate regularly with the CMS POC for the State

Medicaid Office on the progress of the incentive payment system(s).

• Implement the incentive payment system(s).

• Provide required evaluation data, including complete and timely claims and encounter data for the incentive payment systems’ intervention and control groups, in compliance with all applicable laws regarding information sharing

OMH expects successful applicants to work with Partners to:

• Enter into written data-sharing agreements, as appropriate, that comport with all applicable laws regarding information sharing

• Work cooperatively and in good faith for the overall achievement of incentive payment system goals

• Continue to support the incentive payment system and ensure representation from all previously listed stakeholder entities

• Meet on a quarterly basis to review responsibilities related to this grant

C. AUTHORITY

Section 1707 of the Public Health Service Act (42 U.S.C. § 300u-6)

D. FEDERAL AWARD INFORMATION

The Office of Minority Health intends to make funds available for competing grant.

We will fund awards in annual increments (budget periods) and generally for a project period up to 3 years, although we may approve shorter project periods. Budget periods may also vary from the estimate indicated below due to timing of award issuance or other administrative factors. Funding for all approved budget periods beyond the first is generally level with the initial award amount and is contingent upon the availability of funds, satisfactory progress of the project, adequate stewardship of Federal funds, and the best interests of the Government.

Award Information

Estimated Federal Funds Available: $2,500,000.00

Anticipated Number of Awards: 2

Award Ceiling (Federal Funds including indirect costs): $1.25 million per budget period

Award Floor (Federal Funds including indirect costs): $750,000 per budget period

Anticipated Start Date: September 30, 2020

Estimated Project Period: 2 years with possible 3rd year

Anticipated Initial Budget Period Length: 12 months

Type of Award: Grant

Type of Application Accepted: Electronic via Grants.gov ONLY unless an exemption is granted

E. ELIGIBILITY INFORMATION

1. Eligible Applicants.

• State Governments

• County Governments

• City or township governments

• Special district governments

• Independent school districts

• Public and State controlled institutions of higher education

• Native American tribal governments (Federally recognized)

• Public Housing authorities/Indian housing authorities

• Native American tribal organizations (other than federally recognized tribal governments)

• Nonprofits having 501(c)(3) status with the IRS, other than institutions of higher education

• Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education

• Private non-profit institutions of higher education

• U.S. Territories

2. Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget.

3. Application Disqualification Criteria

(a) If you successfully submit an application, we will screen it to ensure it meets the below requirements. If we determine your application fails to meet the criteria described below we will disqualify it, that is, we will not review it and will give it no further consideration.

(b) You must submit your application electronically via www.grants.gov

(unless an exemption was granted 2 business days prior to the deadline) by the date and time indicated in the DATES section (Section A.1) of this announcement.

(c) If you successfully submit multiple applications from the same organization for the same project, we will only review the last application received by the deadline.

(d) HHS/OASH/GAM deems your application eligible according to

Section E.1 Eligible Applicants.

(e) You must complete the required forms in the application package: SF-424, SF-424A, SF-424B, SF-LLL, and Project Abstract Summary.

(f) Your Project Narrative section of the application must be double-spaced, on the equivalent of 8 ½ ” x 11” inch page size, with 1” margins on all sides (top, bottom, left and right) and font size not less than 12 points.

(g) Your Project Narrative must not exceed 50 pages. NOTE: The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF-424B, SF-LLL, Project Abstract Summary, and

Budget Narrative (including budget tables).

(h) Your total application, including the Project Narrative plus Appendices, must not exceed 100 pages. NOTE: items listed in “(f)” immediately above do not count toward total page limit.

(i) Your Federal funds request including indirect costs must not exceed the maximum indicated in Award Ceiling.

(j) Your Federal funds request including indirect costs must not be below the minimum indicated in Award Floor.

(k) Your application must meet the Application Responsiveness Criteria outlined above.

F. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

You may obtain an application package electronically by accessing Grants.gov at http://www.grants.gov/. You can find it by searching on the CFDA number shown on page 2 of this funding opportunity announcement. If you have problems accessing the application or difficulty downloading, contact:

Grants and Acquisitions Management

Phone: 240-453-8822

Email: OASH_Grants@hhs.gov

2. Content and Form of Application Submission

a. Application Format

Your application must be prepared using the forms and information provided in the online application package.

The Project Narrative, and total application including appendices, must adhere to the page limit indicated in Application Disqualification Criteria listed in Section C. The page limit does not include the Budget Narrative (including budget tables), required forms, assurances, and certifications as described in the Application Disqualification Criteria. Please do not number pages or include a table of contents. Our grants management system will generate page numbers once your application is complete. If your application exceeds the specified page limits for the Project

Narrative or Project Narrative plus Appendices when printed on 8.5” X 11” paper by

HHS/OASH/GAM, we will not review it. We recommend you print out your application before submitting electronically to ensure that it is within the page limits and is easy to read.

You must double-space the Project Narrative pages.

You should use an easily readable typeface, such as Times New Roman or Arial. You must use 12-point font. You may single-space tables or use alternate fonts but you must ensure the tables are easy to read.

b. Appendices Format

Your Appendices should include any specific documents outlined in Section D.2.iii., under the heading “Appendices” in the Application Content section of this funding opportunity announcement. Your documents should be easy to read. You should use the same formatting specified for the Project Narrative. However, documents such as résumés/CVs, organizational charts, tables, or letters of commitment may use formatting common to those documents, but the pages must be easy to read. All of your appendices must be uploaded as a single, consolidated file in the Attachments section of your Grants.gov application.

c. Project Abstract Summary Format

You must complete the Project Abstract Summary form provided in the application package. The abstract will be used to provide reviewers with an overview of the application and will form the basis for the application summary in grants management and program summary documents. If your project is funded, HHS may publish information from your form; therefore, do not include sensitive or proprietary information.

d. Budget Narrative Format

The Budget Narrative should use the formatting required of the Project Narrative for the explanatory text. Budget tables may be single-spaced but should be laid out in an easily-readable format and within the printable margins of the page.

3. Application Content

Successful applications will contain the following information:

a. Project Narrative Content

The Project Narrative is the most important part of the application, since it will be used as the primary basis to determine whether your project meets the minimum requirements for an award under this announcement. The Project Narrative should provide a clear and concise description of your project. HHS/OASH recommends that your project narrative include the following components identified by these headings: 1) problem statement and background; 2) project plan;

3) evaluation plan; 4) dissemination plan; 5) sustainability plan; and 6) organizational capability and readiness.

1) Problem Statement and Background

You should describe in this section, in both quantitative and qualitative terms, the nature and scope of the specific and particular problem or issue, and the proposed intervention it is designed to address. You should detail how the project will potentially affect the populations served, specific subgroups within those populations, and other interested stakeholders as identified. We recommend that you focus your problem statement on the specific aspects of the history, existing literature, current status, and policy considerations bearing on the program area, and the roles of the national, state, and local agencies responsible for their operation, rather than providing a broad or sweeping historical overview that is not directly related to the proposed interventions and activities.

Include a description of the burden of SCD disease in your state in both quantitative and qualitative terms. Key data include, but are not limited to, estimated number of SCD patients

(children and adults), incidence based on newborn screening data, patient demographics (e.g., race, gender, income, education, immigrant populations), geography (e.g., urban/rural ratio, large urban centers), estimated percentage of patients (in particular, children) who are Medicaid-eligible, and names and locations of major academic medical centers. Describe the availability of pediatric hematologists at each center, including the number. If available, also include data on estimated hydroxyurea usage rates among children with SCD at the state level and estimate the potential impact that this project may have on increasing hydroxyurea prescription rates.

2) Project Plan

Provide a detailed Work Plan outlining specific activities to be undertaken (based on the needs of the project proposed and project timeline. Your Work Plan should reflect, and be consistent with, the Project Narrative and Budget Narrative, and must cover all years of the project period. However, each year’s activities should be fully attainable in one budget year. You may propose multi-year activities, as well as activities that build upon each other, but each phase of the project must be discreet and attainable within a single budget year. Your Work Plan should include a statement of the project’s overall goal, anticipated outcome(s), key objectives, and the major tasks, action steps, or products that will be pursued or developed to achieve the goal and outcome(s). For each major task of each year, action step, or product, your work plan should identify the timeframes involved (including start- and end-dates), and the lead person responsible for completing the task. Describe the approach that will be used to monitor and track progress on the project’s tasks and objectives. Describe the processes for identifying and convening key partners; developing and providing baseline data for candidate quality measures for each provider type; and developing, promoting, and implementing the final incentive payment system(s).

Describe how you will use the National Standards for Culturally and Linguistically Appropriate

Services in Health and Health Care (National CLAS Standards) to ensure the project will be implemented in a culturally appropriate manner.

Include in your narrative a description of your oversight plan or your approach to developing an oversight plan to ensure that incentivized hydroxyurea prescriptions are medically indicated for the patient. The plan should address patient safety concerns as well as potential fraud risks.

3) Evaluation Plan:

Describe your evaluation design and how your evaluation design will clearly establish whether hydroxyurea quality measure-based incentive payments result in statistically significant increases in hydroxyurea prescriptions. A power analysis, or other technique to establish/demonstrate statistical significance, should also be included. Describe the expected outcomes for your project and how you will measure and report the outcomes. Describe how you will identify best practices and lessons learned in implementing this project. Indicate whether the quantitative data you collect will include pre- and post-intervention hydroxyurea prescribing data for all provider types and emergency department visits data for both control and intervention groups. Applicants are encouraged to consider data for other downstream outcomes measures (e.g., hospitalizations, overall healthcare costs) in addition to emergency department visits. Describe how you will evaluate the quality of the implementation of the National CLAS Standards through process and outcome measures. Describe the relationship between your evaluator and your organization and the degree of independence the evaluator will have.

4) Dissemination Plan

Describe how the project’s results and findings will be documented and disseminated in a timely manner and in easily understandable formats to State Medicaid Offices, the population served, the general public, and other parties who might be interested in using the results of the project. HHS/OASH may publish (including on a website), all appropriate findings and products.

Also, please describe other, innovative approaches to informing parties who might be interested in using the results of your project to inform practice, service delivery, program development, and/or policy-making, especially to those parties who would be interested in replicating the project. HHS expects that nationwide dissemination of products and knowledge will occur.

5) Sustainability Plan

Applications should include a summary for a feasible, time-phased sustainability plan that addresses financial, staff and supervisory, and material resources needed to sustain a successful intervention after the project period ends. Applications also should describe the experience and expertise of the applicant, the State Medicaid Office, and other partner(s) in establishing or supporting the sustainability of health-related projects.

6) Organizational Capability and Readiness:

Please describe in detailed terms your organization’s capabilities to implement this project successfully, including any previous efforts to measure prescription adherence rates for orphan diseases, develop quality measures, and/or implement interventions to improve SCD clinical care.

You should describe how your agency (or the particular division of a larger agency which will have responsibility for this project) is organized, the nature and scope of its work, and the capabilities it possesses.

Describe any data currently available on hydroxyurea usage and emergency department utilization rates within the state or among children with SCD. Outline the data sources you will use to determine hydroxyurea usage rates and emergency room utilization rates and indicate how you would gain access to such data sources. Outline the data sources you will access for other outcomes you propose to measure.

In this section, please also delineate the roles, responsibilities, and qualifications of key project staff and subrecipients, if any, and how they will contribute to achieving the project’s objectives and outcomes. At a minimum, key project staff should include the Principal

Investigator/Project Director and evaluator. OMH expects that, throughout the award period, the

Principal Investigator/Project Director will have day-to-day oversight of, and substantial knowledge about, all aspects of the project.

b. Budget Narrative Content

You must complete the required budget forms and submit a budget narrative with detailed justification as part of your application. You must enter the project budget on the Budget

Information Non-construction Programs standard form (SF 424A) according to the directions provided with this standard form. The budget narrative consists of a detailed line-item budget that includes calculations for all costs and activities by "object class categories" identified on the SF-

424A and justification of the costs. You must indicate the method you are selecting for your indirect cost rate. See Indirect Costs below for further information.

Project budget calculations must include estimation methods, quantities, unit costs, and other similar quantitative detail sufficient to verify the calculations. If matching or cost sharing is required, you must include a detailed listing of any funding sources identified in box 18 of the SF-

424 (Application for Federal Assistance).

Please be sure to carefully review section Funding Restrictions for specific information regarding allowable, unallowable, and restricted costs.

You must provide an object class category budget using Section B, box 6 of the SF 424A for the first year of the proposed project. Provide a budget justification, which includes explanatory text and line-item detail, for the first year of the proposed project. The budget narrative should describe how the categorical costs are derived. Discuss the necessity, reasonableness, and allocation of the proposed costs.

For subsequent budget years, provide a summary narrative and line item budget. For categories or items that differ significantly from the first budget year, provide a detailed justification explaining these changes. Note, do not include costs beyond the first budget year in the object class budget in box 6 of the SF- 424A or box 18 of the SF-424; the amounts entered in these sections should only reflect the first budget year.

Your budget narrative should justify the overall cost of the project as well as the proposed cost per activity, service delivered, and/or product. For example, the budget narrative should define the amount of work you have planned and expect to perform, what it will cost, and an explanation of how the result is cost effective. For example, if you are proposing to provide services to clients, you should describe how many clients are you expecting to serve, the unit cost of serving each client, and how this is cost effective.

Use the following guidelines for preparing the detailed object class budget required by box

6 of the SF-424A. The object class budget organizes your proposed costs into a set of defined categories outlined below. Both federal and non-federal resources (when required) must be detailed and justified in the budget narrative. "Federal resources" refers only to the HHS/OASH funds for which you are applying. "Non-federal resources" are all other non-HHS/OASH federal and non-federal resources. We recommend you present budget amounts and computations in a columnar format: first column, object class categories; second column, federal funds requested;

third column, non-federal resources; and last column, total budget.

Sample Budget Table

Object Class Federal Funds Requested

Non-federal Resources

Total Budget

Personnel

$100,000 $25,000 $125,000

Note, subrecipient/contract and consultant detailed costs should all be included in those specific line items, not in the overall project object class line items, i.e., subrecipient travel should be included in the Contractual line item not in Travel.

1) Object Class Descriptions and Required Justifications

(a) Personnel Description

Costs of staff salaries and wages, excluding benefits.

(b) Personnel Justification

Clearly identify the project director or principal investigator, if known at the time of application. Provide a separate table for personnel costs detailing for each proposed staff person:

the title; full name (if known at time of application), time commitment to the project as a percentage or full-time equivalent: annual salary and/or annual wage rate; federally funded award salary; non-federal award salary, if applicable; and total salary. No salary rate may exceed the statutory limitation in effect at the time you submit your application (see D.6 Funding Restrictions, Salary Rate Limitation for details). Do not include the costs of consultants, personnel costs of delegate agencies, or of specific project(s) and/or businesses to be financed by the applicant.

Contractors and consultants should not be placed under this category.

Sample Personnel Table

Position Title and Full Name

Percent Time Annual Salary Federally-funded Salary

Non-federal Salary

Total Project Salary

Project Director, John K. Doe

50% $100,000 $50,000 $0 $50,000

Data Assistant, Susan R. Smith

10% $30,000 $3,000 $3,000

(c) Fringe Benefits Description

Costs of employee fringe benefits unless treated as part of an approved indirect cost rate.

(d) Fringe Benefits Justification:

Provide a breakdown of the amounts and percentages that comprise fringe benefit costs such as health insurance, Federal Insurance Contributions Act (FICA) taxes, retirement insurance, and taxes.

(e) Travel Description

Costs of travel by staff of the applicant organization only.

(f) Travel Justification

For each trip proposed for applicant organization staff only, show the date of the proposed travel, total number of traveler(s); travel destination; duration of trip; per diem; mileage allowances, if privately owned vehicles will be used; and other transportation costs and subsistence allowances. Do not include travel costs for subrecipients or contractors.

(g) Equipment Description

Equipment means tangible personal property (including information technology systems) having a useful life of more than one year and a per-unit acquisition cost which equals or exceeds the lesser of the capitalization level established by the non-Federal entity for financial statement purposes, or $5,000. (Note: Acquisition cost means the cost of the asset including the cost to ready the asset for its intended use. Acquisition cost for equipment, for example, means the net invoice price of the equipment, including the cost of any modifications, attachments, accessories, or auxiliary apparatus necessary to make it usable for the purpose for which it is acquired. Acquisition costs for software includes those development costs capitalized in accordance with generally accepted accounting principles (GAAP). Ancillary charges, such as taxes, duty, protective in transit insurance, freight, and installation may be included in or excluded from the acquisition cost in accordance with the non- Federal entity’s regular accounting practices.) See 45 C.F.R. § 75.2 for additional information.

(h) Equipment Justification

For each type of equipment requested you must provide a description of the equipment; the cost per unit; the number of units; the total cost; and a plan for use of the equipment in the project;

as well as a plan for the use, and/or disposal of, the equipment after the project ends. An applicant organization that uses its own definition for equipment should provide a copy of its policy, or section of its policy, that includes the equipment definition; include this with your Budget

Narrative file. Reference the policy in this justification and include the policy copy in your Budget

Narrative file (not your appendices).

(i) Supplies Description

Costs of all tangible personal property other than those included under the Equipment category. This includes office and other consumable supplies with a per-unit cost of less than

$5,000.

(j) Supplies Justification

Specify general categories of supplies and their costs. Show computations and provide other information that supports the amount requested.

(k) Contractual Description

Costs of all contracts or subawards for services and goods except for those that belong under other categories such as equipment, supplies, construction, etc. Include third-party evaluation contracts, if applicable, and contracts or subawards with subrecipient organizations

(with budget detail), including delegate agencies and specific project(s) and/or businesses to be financed by the applicant. This line item is not for individual consultants.

(l) Contractual Justification

Demonstrate that all procurement transactions will be conducted in a manner to provide, to the maximum extent practical, open, and free competition. Recipients and subrecipients are required to use 45 CFR § 75.329 procedures and must justify any anticipated procurement action that is expected to be awarded without competition and exceeds the simplified acquisition threshold fixed by 41 U.S.C. § 134 and currently set at $250,000. Recipients may be required to make pre-award review and procurement documents, such as requests for proposals or invitations for bids, independent cost estimates, etc., available to HHS/OASH.

Note: Whenever you intend to delegate part of the project to another agency, you must provide a detailed budget and budget narrative for each subrecipient/contractor, by agency title, along with the same supporting information referred to in these instructions. If you plan to select the subrecipients/contractors post-award and a detailed budget is not available at the time of application, you must provide information on the nature of the work to be delegated, the estimated costs, and the process for selecting the delegate agency.

(m) Other Description

Enter the total of all other costs. Such costs, where applicable and appropriate, may include but are not limited to: consultants; insurance; professional services (including audit charges); space and equipment rent; printing and publication; training, such as tuition and stipends; participant support costs including incentives, staff development costs; and any other costs not addressed elsewhere in the budget.

(n) Other Justification

Provide computations, a narrative description, and a justification for each cost under this category.

(o) Indirect Costs Description

Total amount of indirect costs. This category has one of two methods that you may select.

You may only select one.

• Your organization currently has an indirect cost rate approved by the

Department of Health and Human Services (HHS) or another cognizant federal agency. You should enclose a copy of the current approved rate agreement in your Budget Narrative file. If you request a rate that is less than allowed, your authorized representative must submit a signed acknowledgement that the organization is accepting a lower rate than allowed.

• Per 45 CFR § 75.414(f) Indirect (F&A) costs, “any non-Federal entity

[.,i.e., applicant] that has never received a negotiated indirect cost rate, … may elect to charge a de minimis rate of 10% of modified total direct costs (MTDC) which may be used indefinitely. As described in §

75.403, costs must be consistently charged as either indirect or direct costs, but may not be double charged or inconsistently charged as both.

If chosen, this methodology once elected must be used consistently for all Federal awards until such time as a non-Federal entity chooses to negotiate for a rate, which the non-Federal entity may apply to do at any time.”

This method only applies if you have never received an approved negotiated indirect cost rate from HHS or another cognizant federal agency. If you are waiting for approval of an indirect cost rate, you may request the 10% de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs to the award.

(p) Indirect Costs Justification

Provide the calculation for your indirect costs total, i.e., show each line item included in the base, the total of these lines, and the application of the indirect rate. If you have multiple approved rates, indicate which rate as described in your approved agreement is being applied and why that rate is being used. For example, if you have both on-campus and off-campus rates, identify which is being used and why.

(q) Program Income Description

Program income means gross income earned by your organization that is directly generated by this project if funded except as provided in 45 CFR § 75.307(f). Program income includes but is not limited to income from fees for services performed or the use or rental of real or personal property acquired under the award. Interest earned on advances of Federal funds is not program income. Except as otherwise provided in Federal statutes, regulations, or the terms and conditions of the Federal award, program income does not include rebates, credits, discounts, and interest earned on any of them. See also 45 CFR §§ 75.307, 75.407 and 35 U.S.C. §§ 200-212 (applies to inventions made under Federal awards).

(r) Program Income Justification

Describe and estimate the sources and amounts of program income that this project may generate if funded. Unless being used for cost sharing, if applicable, these funds should not be added to your budget. This amount should be reflected in box 7 of the SF-424A.

(s) Non-Federal…