strong start amended foa 07-03-2012-final-compliant4.pdf

STRONG START FOR MOTHERS AND NEWBORNS

U.S. Department of Health and Human Services

Centers for Medicare & Medicaid Services

Center for Medicare & Medicaid Innovation

Cooperative Agreement

Second Amended Announcement

Funding Opportunity Number: CMS-1D1-12-001

CFDA: - 93.611

Applicable Dates:

Optional Letter of Intent to Apply: August 08, 2012, by 5:00 p.m. EST

Electronic Cooperative Agreement Application Due Date: August 09, 2012 by 5:00 p.m.

EST

Anticipated Notice of Cooperative Agreement Award: October 05, 2012

Cooperative Agreement Period of Performance: The period of performance is four years divided into budget periods that last for 12 months each, beginning on the date of award. This includes three years of service delivery and four years for data reporting on births of intervention infants.

Addendum to Strong Start Funding Opportunity

Funding Opportunity Announcement (FOA) No. CMS-1D1-12-001 has been amended based upon the changes outlined in this second amended FOA. This addendum provides a summary of the amendments to the FOA by section. The amended FOA will immediately follow this addendum.

AMENDMENTS TO THE FUNDING OPPORTUNITY ANNOUNCEMENT

This funding opportunity announcement has been amended and is being reissued. Amendments to the cooperative agreement funding opportunity to support Strong Start for Mothers and Newborns will be included in the body of the funding opportunity announcement in bold and underlined text. This Addendum lists, by section, areas of the funding opportunity announcement that have been amended.

Title Page

• Amended to reflect that this is the second, amended FOA.

• Amended to indicate that the Letter of Intent is optional.

• Amended to reflect extension of the Letter of Intent deadline to August 08, 2012.

• Amended to reflect extension of the Electronic Cooperative Agreement Application Due

Date to August 09, 2012.

• Amended to reflect change in Anticipated Notice of Cooperative Agreement Award to

October 05, 2012.

• Amended to clarify that data reporting is on births of intervention infants.

Overview Information

• Amended to reflect that this is the second, amended FOA.

• Amended to change Date of Issue to July 03, 2012.

• Amended to indicate that the Letter of Intent is optional.

• Amended to reflect extension of the Letter of Intent deadline to August 08, 2012.

• Amended to reflect extension of the Electronic Cooperative Agreement Application Due

Date to August 09, 2012.

• Amended to reflect change in Anticipated Notice of Cooperative Agreement Award to

October 05, 2012.

• Amended to clarify data reporting is on births of intervention infants.

Section I. Funding Opportunity Description

A. Purpose

• Amended to delete the word bid in reference to the competitive process.

• Amended to clarify States are eligible applicants and remove specific reference to

Medicaid agencies.

D. Program Requirements

• Amended to delete language on providing funds to States for providing necessary data.

• Amended to delete applicant requirement to estimate funds needed for data requirements.

• Amended to delete the word base in regards to funding provided for start-up costs.

• Amended to explain that awardees will be expected to collect gestational age and birthweight and provide the same data on births from a baseline period that spans at least 2 years prior to the start of the intervention.

• Amended to remove state letter of agreement requirement.

• Amended to delete requirement that the State submit a description of relevant Medicaid and/or CHIP covered services, and that the State is responsible for coordinating crossover services.

• Amended to remove state partnership requirements.

• Amended to explain that applicants who state their commitment and demonstrate an ability to provide more than 2 years of historical baseline data upon award and/or are able to provide gestational age and birthweight on a comparison population during the intervention period will be viewed favorably.

• Amended to clarify how CMS will independently work with States (outside of this solicitation).

• Amended to insert the word requirements.

• Amended to clarify Awardee quarterly data reporting on operations, utilization, and outcomes requirements.

• Amended to clarify information pertaining to data sources.

• Amended to eliminate requirement for linking vital statistics information and State

Medicaid and/or CHIP data systems through this cooperative agreement funding opportunity.

• Amended to delete reference to comparison entity.

• Amended to delete the word monthly from Continuous provider quality improvement.

Section II. Award Information

B. Award Amount

• Amended to clarify that there is four years of Awardee reporting of data on for intervention infants.

C. Anticipated Award Date

• Amended to reflect change in anticipated award date to October 05, 2012.

D. Period of Performance

• Amended to reflect change in anticipated performance period as October 05, 2012 to

October 04, 2016.

• Amended to clarify that there is four years of Awardee reporting of data on intervention infants.

E. Number of Awards

• Amended to reflect that the letter of intent may provide a vehicle to link potential applicants, instead of stating that it will do so (as a result of making letter of intent optional).

Section III. Eligibility Information A. Eligible Applicants

• Amended to clarify partnership requirements.

• Amended to clarify who must include letters of agreement from provider partners.

• Amended to add the word organizations after managed care.

• Amended to eliminate requirement that awardees provide claims data and vital statistics.

• Amended to explain that awardees are expected to collect gestational age and birthweight and provide the same data on births from a baseline period that spans at least 2 years prior to the start of the intervention.

• Amended to eliminate requirement that Awardees demonstrate engagement with State entities.

• Amended to clarify that CMS foresees providers of proposed interventions responding directly.

• Amended to remove expectation that providers provide evidence of managed care engagement.

• Amended to refer to managed care organizations instead of managed care plans.

• Amended to reflect extension of Application due date to August 09, 2012.

• Amended to clarify that the narrative portions of the application must be double-spaced

(i.e. Project Narrative, Budget Narrative, Work Plan and Timeline).

• Amended to clarify that the Project Abstract should be single-spaced.

• Amended to clarify tables, charts and footnotes should be single-spaced and 10 point type font size.

Section IV. Application and Submission Information

A. Address to Request Application Package

• Amended to clarify that the Letter of Intent is optional.

• Amended to clarify that Letter of Intent must be submitted to use Strong Start Platform.

• Amended to insert information on the use of the online platform to facilitate partnerships.

• Amended to reflect extension of the Letter of Intent submission date to August 08, 2012.

• Amended to update requirements on acceptable application file formats.

• Amended to provide clarifying language on grants.gov review and validation process.

• Amended to reflect extension of the Application Due Date to August 09, 2012.

• Amended to Clarify Office of Acquisition & Grants Management B. Content and Form of Application Submission

• Amended to clarify that font size must be 12-point.

• Amended to clarify which documents are considered part of the narrative portion of the application.

• Amended to clarify tables, charts and footnotes should be single-spaced and 10 point type font size.

• Amended to refer generally to letters of agreement in regards to page limits.

• Amended to insert language on required file format for submission.

• Amended to add the words, if applicable, in regards to LOI identifier.

• Amended to clarify that applicants should indicate the type of applicant (Provider, MCO, convener or State) in the title of the project.

• Amended to eliminate requirement that applicants include documentation from the State outlining State plan services.

• Amended to clarify that applicants should describe relationship with provider partners.

• Amended to explain that applicants must state their commitment and demonstrate their ability to collect gestational age and birthweight for intervention infants during the intervention period.

• Amended to explain that applicants must state their commitment and demonstrate their ability to, upon award, provide the same data on births from a baseline period that spans at least 2 years prior to the start of the intervention.

• Amended to delete requirement that applicants must work with states and managed care plans.

• Amended to refer to national Strong Start program evaluation.

• Amended to clarify that costs for service delivery must be limited to the first three years, and that costs for Awardee reporting of data on intervention infants can be requested in all four years. The fourth year costs must only reflect awardee reporting costs.

• Amended to clarify that the proportion of the requested funding designated for each activity should be clearly defined and should justify the applicant’s readiness to receive funding through 2016. Amended to delete reference to information furnished by the State.

• Amended to eliminate requirement that applicants estimate state costs for reporting requirements.

• Amended to clarify that Awardee reporting of data is on intervention infants.

• Amended to delete language concerning obtaining state level data and compensating

States for this data.

• Amended to delete reference to indirect cost rates and just to refer to indirect costs.

• Amended to include waiver program or other Federal program or funding source.

• Amended to delete reference to funds to states for data activities.

• Amended to clarify which entities must provide Letter(s) of Agreement.

C. Submission Dates and Times

• Amended to clarify that Letters of Intent to Apply are optional.

• Amended to reflect extension of the Letter of Intent deadline to August 08, 2012.

• Amended to reflect extension of the Electronic Cooperative Agreement Application Due

Date to August 09, 2012.

• Amended to reflect change in anticipated announcement date to October 05, 2012.

• Amended to delete such as targeted case management dental services, and home health.

• Amended to refer to managed care organizations instead of managed care plans.

• Amended to refer to the Code of Federal Regulations in addition to the OMB Circulars.

F. Other Submission Requirements

• Amended to include section F. Other Submission Requirements

Section V. Application Review Information

• Amended to clarify Letters of agreement are only required from provider partners.

A. Criteria

• Amended to include bonus points.

• Amended to delete requirement that applicants demonstrate how they will partner closely with States.

• Amended to insert expectation that the applicant will state their commitment and demonstrate their ability to collect gestational age and birthweight for intervention infants during the intervention period.

• Amended to insert expectation that the applicant will state their commitment and demonstrate their ability to, upon award, provide the same data on births from a baseline period that spans 2 years prior to the start of the intervention.

• Amended to explain that applicants who state their commitment and demonstrate an ability to provide more than 2 years of historical baseline data upon award and/or are able to provide gestational age and birthweight on a comparison population during the intervention period will be eligible for bonus points.

• Amended to clarify that proposals should show applicants’ ability to meet data requirements.

• Amended to refer to applicant’s provider partners.

• Amended to delete language about collecting data from States and compensating States for that data.

• Amended to eliminate requirement that applicants estimate the states data costs.

B. Review and Section Process

• Amended to include applicable law (e.g., 2 CFR Parts 180 and 376).

• Amended to include program integrity issues C. Anticipated Announcement and Award Date.

• Amended to reflect change in anticipated announcement date to October 05, 2012.

Section VI. Award Administration Information

D. Cooperative Agreement and Conditions of Award

• Amended to delete phrase, “including the assigned State.”

• Amended to remove state partnership requirement.

Section VIII. Other Information

Appendix C: Measures for Monitoring Quality and Outcomes of Care

• Amended to explain that Awardees will report gestational age and birthweight.

• Amended to explain that awardees must provide the same data on births from a baseline period that spans at least 2 years prior to the start of the intervention.

• Amended to clarify that CMS will independently work (outside of this solicitation) with states to link data.

Appendix E: Maternal & Newborn Health Glossary of Terms

• Amended to include abbreviation for Managed Care Organization (MCO).

Appendix F: Application Check-Off Cover Sheet

• Amended to clarify that SF-LLL: Disclosure of Lobbying Activities is only required for organizations engaging in Lobbying Activities

• Amended to remove state Letter of Agreement requirement.

• Amended to clarify that Letters of Agreement are required from provider partners.

TABLE OF CONTENTS

OVERVIEW INFORMATION

I. FUNDING OPPORTUNITY DESCRIPTION

A. Purpose

B. Authority

C. Background

D. Program Requirements

E. Technical Assistance

II. AWARD INFORMATION

A. Total Funding

B. Award Amount

C. Anticipated Award Date

D. Period of Performance

E. Number of Awards

F. Type of Award

III. ELIGIBILITY INFORMATION

A. Eligible Applicants

B. Cost Sharing/Matching

C. Foreign and International Organizations

D. Faith-Based Organizations

E. Community-Based Organizations

F. Tribal Organizations

IV. APPLICATION AND SUBMISSION INFORMATION

A. Address to Request Application Package

B. Content and Form of Application Submission

1. Form of Application Submission

2. Overview of Cooperative Agreement Application Structure and Content

a. Standard Forms

b. Cover Letter

c. Project Narrative

d. Budget and Budget Narrative

i. Budget SF 424A

ii. Budget Narrative

iii. Additional Cost Considerations

e. Letter(s) of Agreement

f. Work Plan and Timeline

C. Submission Dates and Times

D. Intergovernmental Review

E. Funding Restrictions Interaction with Medicaid and/or CHIP Payment Policy

F. Other Submission Requirements

V. APPLICATION REVIEW INFORMATION

A. Criteria

B. Review and Selection Process

C. Anticipated Announcement and Award Date

VI. AWARD ADMINISTRATION INFORMATION

A. Award Notices

B. Administrative and National Policy Requirements

C. Terms and Conditions

D. Cooperative Agreement and Conditions of Award

E. Reporting

1. Progress Reports

2. Quarterly Data Reporting on Operations, Utilization, and Outcomes

3. Federal Financial Report (FFR)

4. Transparency Act Reporting Requirements

5. Audit Requirements

6. Payment Management Requirements

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: INSTITUTE OF MEDICINE RISK FACTORS FOR PRETERM BIRTH

APPENDIX B: COMPARISON OF ENHANCED PRENATAL CARE APPROACHES

APPENDIX C: MEASURES FOR MONITORING QUALITY AND OUTCOMES OF CARE

APPENDIX D: STATE MEDICAID MATERNITY CORE SET OF MEASURES

APPENDIX E: MATERNAL & NEWBORN HEALTH GLOSSARY OF TERMS

APPENDIX F: APPLICATION CHECK-OFF COVER SHEET

APPENDIX G: GUIDANCE FOR PREPARING A BUDGET REQUEST AND NARRATIVE IN RESPONSE TO SF 424A

OVERVIEW INFORMATION

Agency Name: Department of Health and Human Services

Centers for Medicare & Medicaid Services

Center for Medicare & Medicaid Innovation

Funding Opportunity Title: STRONG START FOR MOTHERS AND NEWBORNS

Announcement Type: Second Amended

Funding Opportunity Number: CMS-1D1-12-001

Catalog of Federal Domestic Assistance (CFDA) Number: 93.611

Key Dates:

Date of Issue: July 03, 2012

Optional Letter of Intent Submission Date: August 08, 2012, by 5:00 p.m. ET

Application Due Date: August 09, 2012 by 5:00 p.m. ET

Anticipated Notice of Award: October 5, 2012

Period of Performance: The period of performance is four years divided into budget periods that last for 12 months each, beginning on the date of award. This includes three years of service delivery and four years for data reporting requirements on births of intervention infants.

I. FUNDING OPPORTUNITY DESCRIPTION

A. Purpose

The Centers for Medicare & Medicaid Services, (CMS) Center for Medicare and Medicaid Innovation (Innovation Center) is interested in testing new care and payment models that have the potential to improve perinatal outcomes for women enrolled in Medicaid and/or Children’s Health Insurance Program (CHIP) who are at high-risk for adverse pregnancy outcomes. This initiative is a partnership between the Innovation Center and the Center for Medicaid and CHIP Services (CMCS) and part of a larger HHS effort to improve maternal and infant health outcomes.

In this four-year initiative the Innovation Center will offer a funding opportunity to eligible applicants to test the impact of providing enhanced prenatal care interventions for women with Medicaid and/or CHIP coverage who are at high risk for having a preterm birth. The initiative will test 3 distinct approaches to providing enhanced prenatal care delivery. Each approach provides a set of specific and comprehensive interventions to improve current, traditional prenatal care delivery and address additional clinical, behavioral, and psychosocial factors that may be present during pregnancy and contribute to preterm-related poor birth outcomes.

This funding opportunity will award, through a competitive process, cooperative agreements for States, providers, managed care organizations and conveners to test the ability of three such approaches to improve outcomes in approximately 90,000 pregnancies. The Innovation Center proposes to fund the cost of care for 30,000 women in each of the three approved options for enhanced prenatal care.

The ultimate purpose of this initiative is to achieve the three-part aim of better care, improved health and reduced costs by improving outcomes for high-risk pregnant Medicaid and/or CHIP beneficiaries. Specifically, the goal is to determine whether these new approaches to care can increase the gestational age of neonates sufficiently to decrease the anticipated total cost of medical care over the first year of life for children born to high risk mothers. To date, most efforts to address preterm births have focused on clinical interventions delivered in the traditional care delivery sites, in many cases initiated after labor began.1 There is a growing body of research which suggests interventions that address behavioral and socio-economic dimensions of women’s lives may successfully prevent some preterm births. This initiative will focus specifically on the impact of non-medical prenatal interventions that, when provided – in addition to routine obstetrical medical care – are believed to reduce rates of preterm births for these women.

Each of the options outlined in this funding opportunity are designed to provide a specific combination of non-medical prenatal interventions that have been found to reduce rates of preterm births for women particularly at risk for having a preterm birth. These promising approaches are currently being implemented in various forms across the country but are not typically paid for through current reimbursement systems.

The evidenced-based approaches being tested in this initiative are encapsulated in the following 3 options for applicants:

1. Enhanced Prenatal Care through Centering/Group Care – Group prenatal care that incorporates peer-to-peer support in facilitated, face-to-face sessions for three components:

health assessment, education, and support occurring within approximately 10 prenatal sessions. This approach focuses on building peer-support relationships.

2. Enhanced Prenatal Care at Birth Centers – Comprehensive prenatal care facilitated by midwives and teams of health professionals including peer counselors and doulas. Services include collaborative practice, intensive case management, counseling and psychosocial support services in addition to traditional prenatal care. This approach focuses on building relationships between caregivers and patients.

3. Enhanced Prenatal Care at Maternity Care Homes – Enhanced prenatal care including psychosocial support, education, and health promotion in addition to traditional prenatal care.

In this approach, services are delivered in practices described as maternity care homes.

CMS will award, through a competitive process, a set of renewable one-year cooperative agreements to eligible applicants who enter into agreements to implement one of these enhanced prenatal care approaches. CMS will evaluate the potential for these evidence-based approaches to decrease morbidity, mortality and the first year of medical costs of prematurity. The Strong Start Program will operate for four years; including three years for intervention and four years for data collection and submission.

Eligible applicants in this funding opportunity include:

• States;

• Providers of obstetric care (provider groups and/or affiliated providers and facilities);

• Managed care organizations (MCOs); and

• Conveners in partnership with other applicants. The convener may be a direct applicant, or may convene and support other organizations to become applicants. Examples of conveners include states, associations of providers, or other health service related organizations.

Each of the options will present eligible applicants with unique challenges specific to their organizational structure and capability. Applicants should carefully consider each approach and its fit with their organizational structure and capability. Regardless of which option an applicant chooses to pursue, it is required that it clearly identify which, if any, of the specific interventions outlined in each approach it is already being reimbursed or for which reimbursement is already available. The funding provided by this initiative cannot be used to pay for services for which reimbursement is already available.

B. Authority This solicitation is being issued under section 1115A of the Social Security Act (added by Section 3021 of the Affordable Care Act), which authorizes the Innovation Center to develop, implement, and evaluate innovative payment and service delivery models to reduce program expenditures under Medicare, Medicaid, and CHIP while preserving or enhancing the quality of care. Pursuant to section 1115A(c), a model being tested by the Innovation Center may, through rulemaking, be expanded or “scaled,” including through implementation on a nationwide basis, if certain findings are made regarding the effect of the expansion on program spending and the quality of patient care.

C. Background

Medicaid and Births in the United States

In the United States, approximately 12 percent of infants (more than half a million a year) are born prematurely, with that rate increasing by 36 percent over the last 20 years. The rate of preterm births, medically defined as less than 37 weeks of gestation, is a growing public health problem that has significant consequences for families and has been estimated to cost society at least $26 billion each year.2 These costs extend beyond the walls of the NICU since infants born preterm are at greater risk for mortality and many endure a lifetime of health and developmental problems. In addition to enormous medical needs, these children often require early intervention services and special education and have conditions that impact their productivity as adults.

Medicaid currently finances about 40% of all births in the United States. Current Federal law requires States to extend eligibility for pregnancy-related care to pregnant women with incomes up to 133% of the federal poverty level and allows States to cover pregnant women with higher incomes as well. In an effort to improve access to prenatal care and birth outcomes, Federal law changed in the mid-1970s to make Medicaid coverage available to pregnant women with incomes up to 133% of the federal poverty level. Yet Medicaid beneficiaries continue to have a rate of preterm birth that is significantly higher than the rate for all other women (11.9% vs.

8.7%).3 The incidence of preterm births continues to vary significantly depending on geography, race, and ethnic background and is thus a significant source of health disparities across the country. Among Medicaid beneficiaries in 2008, the preterm birth rate for African-American women was 17.5 percent, while the rates were 12.1 percent for Hispanic women and 11.1 percent for white women.4

Many different medical interventions have been used to attempt to improve preterm birth rates.

Some medical interventions, such as the use of 17 Hydroxy- Progesterone, have been demonstrated to have positive results in select populations. However, in spite of such interventions, the rate of prematurity has, as noted above, nevertheless increased significantly over the past 20 years, and until a slight improvement recently, had been steadily increasing5.

Most authorities believe that while the causes of prematurity are multiple and not fully understood, underlying behavioral and socio-economic factors play a meaningful role.

Over the past 15 years, a variety of non-medically based interventions have been explored that focus on addressing psychological and socio-economic issues.6 Some small studies of these programs have reported significant decreases in preterm rates. To date, however, these models have only been tested in limited settings with small numbers of participants. The impact of these models has not been fully explored and tested among women enrolled in Medicaid and/or CHIP.

As a result, many States and managed care plans may be using such enhanced prenatal care models without strong evidence for their ultimate effectiveness. At the same time other States and managed care plans may not be providing these services at all.

Although all State Medicaid programs are required to pay for traditional prenatal care and deliveries, there is great variation in how States cover non-traditional health services under Medicaid. Acknowledging that these additional services require additional time and often additional members in the health care team, the Innovation Center will award funds to eligible states, providers, managed care organizations and conveners who demonstrate plans for incorporating one of the three options of enhanced care into their current prenatal plans.

A fourth approach to evidence-based enhanced prenatal care – structured home visiting during pregnancy – has also demonstrated the potential to reduce preterm births. CMS is interested in learning if this model for enhanced prenatal care also reduces the rate of prematurity, and will work (outside of this solicitation) with the Health Resources and Services Administration (HRSA) and the Administration on Children and Families (ACF) to study this intervention through their existing Maternal, Infant, and Early Childhood Home Visiting program

(MIECHV).

Medicaid Beneficiaries are at Increased Risk for Preterm births

Several risk factors for preterm birth have been well-described in the medical literature. In addition to medical risk factors, research has examined how social and psychosocial factors may influence the risk of preterm birth. 7, 8 These factors interact with each other on a multitude of levels. An individual with a constellation of these risk factors is at a higher risk for preterm birth or other poor birth outcome in comparison to an individual without or with fewer of these factors. The chart in Appendix A, modified from the Institute of Medicine Report, shows risk factors associated with preterm birth.9 Applicants will be asked to identify the risk factors for preterm birth present in the areas they propose to deliver services. Applicants should use available data sources to assess and describe the risk factors present.

The ensuing issues are among those that have been found to be related to the risk for preterm births.

• Prior History of Pre-Term Delivery: Women that have prior medical history involving pre-term delivery and births are an obvious target for improved prenatal care and medical management in subsequent pregnancies.

• Poverty: The relationship between income and health is well-established.10 Several studies have documented that rates of preterm and low-birthweight are higher among women living in poverty than for higher-income women.11 Many factors are believed to contribute to income-associated disparities in birth outcomes, some of which may be addressable by the intervention options offered by this program. Women with family incomes below the poverty level are more likely than other women to experience social stressors related to housing, employment, and neighborhood conditions. Additionally, poverty can affect a mother’s nutritional intake, which is critical for a healthy newborn, and also can result in financial and other barriers (e.g., lack of transportation) to accessing timely and high-quality prenatal care.

Race and Ethnicity: Preterm birth rates vary substantially by race and ethnicity.

African-American women have the highest rates of preterm births by significant margins.

Most studies that have controlled for differences in socio-economic status (SES) continue to find poorer birth outcomes among African-American women as compared to non- Hispanic Whites. African-American, Puerto Rican, and American Indian women at every level of SES have higher rates of poor birth outcomes than their white counterparts.12 This fact suggests that lower SES alone does not explain fully disparities in birth outcomes. However, there is also substantial evidence that women of lower SES (as defined by education) do indeed have higher rates of poor birth outcomes. For other minority groups, preterm birth rates have increased since 1990. Between 1990 and 2006, preterm birth rates increased for American Indian or Alaskan Native infants (from 6.1 to

7.5 percent) and Asian or Pacific Islander infants (from 6.5 to 8.1 percent).13 (See Figure 1)

Figure 1. Rates of Preterm Births, by Race/Ethnicity

NOTE: Data for 2009 are preliminary. Race refers to mother's race. The 1977 Office of Management and Budget (OMB) Standards for Data on Race and Ethnicity were used to classify persons into one of the following four racial groups: White, Black, American Indian or Alaskan Native, or Asian or Pacific Islander. Persons of Hispanic origin may be of any race.14

• Substance Abuse: Smoking is one of the most important modifiable causes of poor pregnancy outcomes in the United States, and is associated with maternal, fetal, and infant morbidity and mortality. An estimated 5–8% of preterm deliveries, 13–19% of term deliveries of infants with low birthweight, 23–34% cases of sudden infant death syndrome (SIDS), and 5–7% of preterm-related infant deaths can be attributed to prenatal maternal smoking. 15

Programs for cessation of tobacco, drug, and alcohol use have been recommended as part of a strategy to reduce spontaneous preterm births. Effective smoking cessation programs have been shown to reduce preterm birth and increase birthweight.16 In addition, an office-based protocol that systematically identifies pregnant women who smoke and offers treatment or referral has been proven to improve cessation rates. A short counseling session with pregnancy-specific educational materials and a referral to a smokers’ quit line has also been found to be an effective smoking cessation strategy.17

D. Program Requirements The solicitation will offer direct funding to applicants for the purpose of providing specific combinations of enhanced prenatal care services, as outlined in the 3 options (approaches) detailed in this document (see Appendix B). Each applicant can propose to implement more than one option but only one option can occur at an individual practice. It will also offer funding to the applicants for start-up and implementation costs associated with developing and implementing the approaches defined in this FOA.

Strong Start funding may not be duplicative of other Federal funding opportunities for information technology capacity building such as assistance provided through Medicaid, ARRA, HITECH, ONC or other CMS initiatives. The intent of this proposal is to complement, not supplant any of these or other Federal programs.

Option 1: Enhanced Prenatal Care through Centering/Group Visits

“Centering” is an approach of care which combines three important components of enhanced prenatal care – medical appointments, education, and support – in group appointments. 18 Pregnant women receive care from health care providers in group settings with other pregnant women with similar gestational ages. The participants meet with their care provider and their cohort approximately 10 times during their pregnancy for a much longer period of time than a usual check-up visit. Through the clinical and psycho-social supportive services provided in this model, women have been found to choose health-promoting behaviors from peer to peer support, which in turn may result in improved birth outcomes and increased maternal satisfaction with the care provided.

This model has been formalized by the Centering Healthcare Institute (CHI), a not-for-profit organization focused on promoting group-based care, as “CenteringPregnancy.” CHI provides education and support to practices seeking to adopt their CenteringPregnancy approach and “site approves” practices as CenteringPregnancy locations. The CenteringPregnancy model has shown promise in reducing adverse birth outcomes, including low birthweight and preterm birth.19,20, 21

• As per the Centering model, pregnant women will enter the program prior to 18 weeks of pregnancy, and complete eight to ten visits that are approximately 90 to 120 minutes.

• Sessions will include a standard risk assessment, including review of interim history and a physical examination, patient self-monitoring and group discussion facilitated by the health care provider. This discussion includes emphasis on health education, counseling and peer support.

While one goal of this FOA is to test the effectiveness of a group-based, “centered” approach to prenatal care, we are not requiring applicants to seek or receive “site approval” by CHI or demonstrate fidelity to the CenteringPregnancy model as outlined by CHI. However, we do encourage practices that are “site approved” by CHI to apply and demonstrate the effectiveness of the investments and commitment they have already made. Applicants that are not “site approved” or that do not follow the specific CHI model for CenteringPregnancy will need to provide the evidence base for how they will implement “centering” and demonstrate how it has been successful. This FOA does not constitute an endorsement of or effort to endorse the CHI or CenteringPregnancy.

Option 2: Enhanced Prenatal Care at Birth Centers

Birth centers are sources of maternity care facilitated by midwives and other highly qualified professionals from nursing, obstetrics, family medicine, pediatrics, nutrition, social work, physical fitness, childbirth and parenting education disciplines that offer psychosocial support services. Midwives at these centers utilize alternative family-centered techniques to support natural births and provide psychosocial support services during the course of the visits. In most cases, the Birth Center midwives and physicians will attend the delivery in an affiliated hospital, should that become necessary. Generally, there are two models of birth centers—freestanding centers and those that are a unit of or owned by a tertiary care hospital or health system.

Birth centers provide a full range of health and social services including prenatal clinical care, support through labor, delivery and postpartum care. The majority of research done on birth centers has focused on the difference in the labor and delivery for women in birth centers as compared to hospital births. However, some research does suggest that both traditional and enhanced care delivered during pregnancy may account for positive birth outcomes.22 The enhanced prenatal care package provided at birth centers often includes case management and referral services, improved continuity of care, counseling, and a range of behavioral risk reduction programs.23,24 Visits tend to be longer, focus on health education, nutrition services, and psychosocial support and are often provided by a team of licensed and unlicensed professionals including peer counselors, doulas, and lactation consultants.25

• Birth Centers can be either free-standing or provider affiliated.

• Birth Centers must be accredited by The Commission for the Accreditation of Birth

Centers, licensed, or otherwise approved by the State to provide prenatal labor and delivery or postpartum care and other ambulatory services.

• Funding is available to freestanding birth centers to the extent that they are already recognized for coverage and payment by a State’s Medicaid and/or CHIP program.

Option 3: Enhanced Prenatal Care at Maternity Care Homes

The Maternity Care Home model integrates a comprehensive set of non-clinical services into the current offering of traditional prenatal care. Although many maternity care models have been implemented around the nation, no single stand-alone intervention has shown to be effective in reducing preterm birth.26 However, literature has shown promising success when a set of prenatal services is collectively implemented throughout the course of a woman’s prenatal care.

These successful interventions provide an evidence base for testing enhanced maternity home models.27,28 Services in a maternity care home include clinical aspects of prenatal care, as well as services that address behavioral, psychological, and social factors that a woman may face during a pregnancy. These enhanced services could be provided by both licensed and unlicensed professionals, offering services that include but are not limited to nutritional and psychosocial counseling, health education, and case management.

Applicants applying for the Maternity Care Home approach must describe how they intend to provide the following elements of care:

1. Access and Continuity: Critical first steps of a successful comprehensive maternity care model are to get pregnant women into care and help them stay in care. Markers of successful enhanced prenatal care include enrolling women into Medicaid and/or CHIP services29 and providing nurse outreach to patients during visits and between visits.30,31 Health providers should be easily accessible when a patient needs care including after usual business hours by offering expanded office hours, a 24-hour nurse support line, direct access to prenatal providers, or other comparable access. Services must be culturally and linguistically appropriate. Therefore, applicants must demonstrate activities to enroll pregnant women who are eligible, but are not currently enrolled in Medicaid, demonstrate how patients have direct access to providers between scheduled visits, and demonstrate capacity to have patients receive care consistently from the same primary provider.

2. Care Coordination: Patient care must be organized and coordinated both within the practice and with outside consultants. Markers of success include having a care navigator create a mutually agreed-upon care plan with patients32 and having patients referred to and enrolled in community support services, such as the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). 33,34, 35, 36 In consultation with their patients, providers should create a care plan/birth plan to assure that patients understand the plan of care and that the plan is congruent with patient choices and values. Practices must demonstrate the ability to provide key information to other services and providers, and to receive it in return.

Enhanced Content: During a prenatal visit, providers must make enhanced prenatal services and education available to all patients, as necessary. Markers of success include integrating smoking cessation interventions37 into prenatal care and providing health education to women during prenatal care visits.38 Providers shall describe the package of enhanced prenatal services they will provide, specifying how it goes beyond traditional, clinical prenatal care. Psychosocial services must be integrated into the prenatal practice.

For all approaches

The solicitation will offer direct funding for the provision of enhanced prenatal care in each of the specified care models. Funding should be calculated as a particular amount per pregnant woman who completes the pregnancy at the relevant site (see example in Budget Narrative). In addition, a portion of this funding will be available for start-up costs associated with developing the models and for on-going administrative costs. Awardees will be expected to collect gestational age and birthweight for the infants of the mothers participating in the proposed intervention. These infants (referred to throughout as intervention infants) are born during the intervention period to mothers who participated in the enhanced prenatal care approach proposed by the applicant. Awardees must also be able to provide the same data on births from a baseline period that spans at least 2 years prior to the start of the intervention. This funding shall not supplant existing payment for services that may already be provided under current State Plans and waiver programs. Funding is not available to supplement payment for services that are currently offered. Funds may, however, be used to help defray the costs of providing additional services that are not reimbursed but are ancillary activities that support clinical services, such as staff training, coordinating and consulting on care for enrolled women, and physical space improvements. Applicants will be required as part of their applications to detail current Medicaid, CHIP and federally covered perinatal services in their State, as well as describe the proposed enhanced services or benefits. CMS will verify applicant information regarding service description, identification of the provider type, and the rate and reimbursement methodology by way of state plans and waivers on record.

MONITORING AND EVALUATION

1. Monitoring

The purpose of monitoring is to ensure that implementation is occurring safely and appropriately at the practice level, and that adequate patient protections are in place. CMS will monitor awardees participating in this initiative to ensure that access to care is not being compromised.

The awardees will be expected to collect and report, on a quarterly basis, metrics that are consistent with the goals of the model. The specific metrics will be detailed and affirmed as part of the terms and conditions for the cooperative agreement. Measures will be determined based on measures such as those compiled as part of the Physician Consortium for Performance Improvement® (PCPI).39 This set of measures aims to assess the improvement of care for women during pregnancy, delivery, and post-partum (Appendix C). The PCPI was convened by The American Congress of Obstetricians and Gynecologists (ACOG), the National Committee for Quality Assurance (NCQA) and the American Medical Association.

These measures are consistent with the goals and objectives of the Strong Start program and specifically meant to be used at the clinician level. They include measures that will help monitor the quality and success of the delivery of enhanced prenatal care services.

Awardees will also be expected to report on their outreach and targeting activities and on their success in engaging at-risk populations. The information provided in the self-reported progress reports will be augmented with analyses by the CMS support contractor. Awardees will be expected to collect gestational age and birthweight for the infants of the mothers participating in the proposed intervention. The awardee must also be able to provide the same data on births from a baseline period that spans at least 2 years prior to the start of the intervention. CMS will look favorably upon applicants who state their commitment and demonstrate an ability to provide more than 2 years of historical baseline data upon award. CMS will also look favorably upon applicants who state their commitment and demonstrate an ability to provide gestational age and birthweight on a comparison population during the intervention period.

CMS will independently work (outside of this solicitation) with states to collect vital statistics and Medicaid and/or CHIP claims and encounter data. CMS seeks to link vital records and Medicaid and/or CHIP data, as possible, and provide this data, linked at the individual level, to the CMS evaluator. These data will supplement the comparison of gestational age and birthweight in the baseline and intervention periods as reported by the Strong Start awardees. CMS will also independently work with States to collect data on the Medicaid Maternity Core Set of Quality measures (Appendix D). Health system utilization data such as inpatient length of stay for mother and baby, NICU use, type of birth (vaginal or C-section), cost of care, and health care utilization and cost of care during pregnancy and for the infant's first year of life obtained through this independent work with states will support a broader evaluation of the Strong Start models.

States that are primary applicants under this funding opportunity announcement should report gestational age and birthweight for intervention infants, as well as, upon award, historical data on births from a baseline period that spans at least 2 years prior to the start of the intervention. Collection of vital records, Medicaid/CHIP claims, and Medicaid/CHIP encounter data and the required data linkages beyond those described in section VI, Award Administration Information, will be pursued independently with States.

Agreements between States and CMS for these additional data, and compensation for providing such data, will also be pursued independently of this solicitation.

Progress Report: The awardee is required to submit quarterly, semi-annual (every six months), annual, and final reports to the CMS Project Officer. These reports are to be submitted online, through CMS’ web-based system. Content requirements of the progress reports will be detailed in the Standard and Special Terms and Conditions, but will at a minimum include information such as:

• The specific use(s) of the cooperative agreement funds.

• An assessment of overall project implementation, including lessons learned and best practices.

• An assessment of quality improvements and clinical outcomes of Medicaid and/or CHIP beneficiaries.

• Estimates of cost savings resulting from the cooperative agreement-funded activities.

• An evaluation of the degree to which the intervention is achieving its purposes, aims, goals, objectives, and quantified performance targets.

• An account of barriers that were encountered and how were they addressed.

• A discussion of lessons that were learned as a result of the intervention and recommendations for others who might be interested in implementing a similar approach.

Quarterly Data Reporting on Operations, Utilization, and Outcomes: Awardees must submit quarterly data as needed for monitoring and evaluation of the project. The format and details of this data reporting will be determined at the start of the project in collaboration with the monitoring and independent evaluation teams. For planning purposes, the applicants should expect to provide the following types of information:

Operations and Utilization: The awardees will report information regarding the operations of the project as well as certain aspects of utilization, which may include staffing, number of women identified for the project, number of educational and support sessions with women, types of sessions, etc.

Outcomes: The awardees will report gestational age and birthweight for intervention infants. Awardees must also be able to provide the same data on births from a baseline period that spans at least 2 years prior to the start of the intervention.

2. Measurement and Evaluation Plan

CMS’ evaluation will inform policy makers about the impact of each of the initiative’s prenatal care models on reducing the rate and degree of pre-term births and on reducing adverse pregnancy outcomes. Health improvement and expenditure outcomes to be described and evaluated may include:

• Type of delivery system – including whether Medicaid/CHIP is FFS or managed care

• Gestational age at delivery

• Frequency of ongoing prenatal care

• Timeliness of prenatal care

• Delivery method (cesarean, vaginal)

• Elective delivery prior to 39 weeks versus completed gestation

• Appropriate use of antenatal steroids

• Appropriately timed postpartum care

• Frequency of low birthweight

• Average length of stay for delivery

• Unplanned maternal admission to ICU

• NICU admission, length of stay and associated costs

• Medical costs of infants first year of life

• Total cost of care (cost of pregnancy, delivery and first year medical costs for infant)

Data Sources and Possible Evaluation Frameworks Data availability and program designs are expected to vary by awardee. As a result, several designs will be employed to evaluate program effectiveness. CMS’ third-party evaluators will employ the most rigorous set of evaluation designs, as proves feasible, for the awarded projects.

Data Sources: CMS will work closely with the awardees to establish the best possible baseline and trends to assess the outcomes of intervention infants. Awardees will be expected to provide historical data on gestational age and birthweight for a baseline period that spans at least 2 years prior to the start of the intervention. The evaluation contractor will design the evaluation and include primary data collection where necessary.