Status Report on Protecting Our Infants Act Implementation Plan

Substance Abuse and Mental Health Services Administration

January 17, 2019

Printer Friendly Version in PDF Format (109 PDF pages)

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ABSTRACT

The Protecting Our Infants Act of 2015 (POIA) became law on November 25, 2015. The Act (Public Law 114-91) addressed problems related to prenatal opioid exposure called for HHS to review planning and coordination of HHS activities related to prenatal opioid exposure and neonatal abstinence syndrome (NAS), and to study and develop recommendations for the prevention, identification, and treatment of NAS as well as the treatment of opioid use disorder (OUD) in pregnant women. In May of 2017 HHS released a POIA strategy to address gaps in research, overlap of federal programs and coordination of federal efforts to address NAS and NOWS. Section 7062 of the SUPPORT for Patients and Communities Act (P.L. 115-271, enacted October 24, 2018) requires a report about the implementation of the recommendations in the POIA strategy, to be submitted to specified congressional committees and made available to the public on the Department's website. HHS developed an implementation plan focusing on preventing prenatal opioid exposure, providing evidence-based treatment for both mother and infant, increasing the accessibility of family-friendly services for pregnant and parenting women with OUD, supporting continuing education for healthcare providers, and determining optimal family and developmental support services for children who have experienced prenatal opioid exposure. [101 PDF pages]

For additional information about this subject, you can visit the HHS/ASPE/Office of Disability, Aging and Long-Term Care Policy home page at http://aspe.hhs.gov/office-disability-aging-and-long-term-care-policy-daltcp or contact the ASPE Project Officer, Kristina West, at HHS/ASPE/DALTCP, Room 424E, H.H. Humphrey Building, 200 Independence Avenue, S.W., Washington, D.C. 20201, Kristina.West@hhs.gov.

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ABBREVIATIONS

AAP	American Academy of Pediatrics
ACF	Administration for Children and Families
ACT NOW	Advancing Clinical Trials for Neonatal Opioid Withdrawal
ACYF	Administration on Children, Youth and Families
ACOG	American College of Obstetrics and Gynecology
AFCARS	Adoption and Foster Care Analysis and Reporting System
AHRQ	Agency for Healthcare Research and Quality
AIM	Alliance for Innovation on Maternal Health
AIMS	Access Increases in Mental Health and Substance Abuse Services
AI/AN	American Indian/Alaskan Native
ASHTO	Association of State and Territorial Health Officials
ASPE	Office of the Assistant Secretary for Planning and Evaluation
BHCC	Behavioral Health Coordinating Council
BRFSS	Behavioral Risk Factor Surveillance System
CAHPG	Children and Adults Health Programs Group
CARA	Comprehensive Addiction and Recovery Act of 2016
CAPTA	Child Abuse Prevention and Treatment Act
CDC	Centers for Disease Control and Prevention
CEU	Continuing Education Units
CME	Continuing Medical Education
CMCS	Center for Medicaid and CHIP Services
CMMI	Center for Medicare and Medicaid Innovation
CMS	Centers for Medicare & Medicaid Services
CONACH	Committee on Native American Child Health
CSAT	Center for Substance Abuse Treatment
CSTE	Council of State and Territorial Epidemiologists
DAST	Drug Abuse Screening Test
DBP	Developmental-Behavioral Pediatrics
DEHPG	Disabled and Elderly Health Programs Group
ECHO	Extension for Community Care Outcomes
EPSDT	Early and Periodic Screening, Diagnostic and Treatment
ESC	Eat, Sleep, Console
FASD	Fetal Alcohol Spectrum Disorders
FOA	Funding Opportunity Announcement
GAO	Government Accountability Office
GPRA	Government Performance and Results Act
HCUP	Healthcare Cost and Utilization Project
HEDIS	Healthcare Effectiveness Data and Information Set
HHS	Health and Human Services
HIV/AIDS	Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome
HOPE	Heroin, Opioids, and Pain Efforts
HRSA	Health Resources and Services Administration
IAA	Institutional Review Board Authorization Agreements
IAP	MedicaidInnovation Accelerator Program
ICD	International Statistical Classification of Diseases
IDeA	Institutional Development Awards
IMD	Institutions for Mental Diseases
IHS	Indian Health Services
ISPCTN	IDeA States Pediatric Clinical Trials Network
IUD	Intrauterine Device
LARCs	Long-acting reversible contraceptives
LAUNCH	Linking Actions for Unmet Needs in Children's Health
MAT	Medication-Assisted Treatment
MAT-PDOA	Medication-Assisted Treatment--Prescription Drug and Opioid Addiction
MCH	Maternal and Child Health
MCHB	Maternal and Child Health Bureau
MIECHV	Maternal, Infant, and Early Childhood Home Visiting
MMRC	Maternal Mortality Review Committees
MOU	Memorandum of Understanding
NAS	Neonatal Abstinence Syndrome
NCANDS	National Child Abuse and Neglect Data System
NCSACW	National Center on Substance Abuse and Child Welfare
NICHD	The Eunice Kennedy Shriver National Institute of Child Health and Human Development
NICU	Neonatal Intensive Care Unit
NIDA	National Institute on Drug Abuse
NOWS	Neonatal Opioid Withdrawal Syndrome
NRN	Neonatal Research Network
NSDUH	National Survey on Drug Use and Health
OASH	Office of the Assistant Secretary for Health
OAT	Opioid Addiction Treatment
OCA	Office of Community Awareness
OCAN	Office on Child Abuse and Neglect
OMB	Office of Management and Budget
OTC	Over-The-Counter
OUD	Opioid Use Disorder
OWH	Office on Women's Health
OWHPA	Office on Women's Health Prevention Award
PCSS-O	Providers' Clinical Support System--Opioid Therapies
PICs	Practice and Implementation Centers
POIA	Protecting Our Infants Act
PPW	Pregnant and Postpartum Women
PQC	Perinatal Quality Collaboratives
PRAMS	Pregnancy Risk Assessment Monitoring System
RCT	Randomized Controlled Trial
RFA	Request For Application
RHOP	Rural Health Opioid Program
SAMHSA	Substance Abuse and Mental Health Services Administration
SABG	Substance Abuse Prevention and Treatment Block Grant
SBIRT	Screening, Brief Intervention, and Referral to Treatment
SEI IDTA	Substance Exposed Infant In-Depth Technical Assistance Program
SGM	Special General Memorandums
SNOMED	Systematized Nomenclature of Medicine
SUD	Substance Use Disorder
TA	Technical Assistance
UDS	Uniform Data System

BACKGROUND

A new study revealed that from 2004 to 2014, the rate of US infants diagnosed with opioid withdrawal symptoms increased 433%, from 1.5 to 8.0 per 1000 hospital births. This translates to one infant being born every 15 minutes with withdrawal symptoms due to prenatal opioid exposure. [1], [2]

The Protecting Our Infants Act of 2015 (POIA) became law on November 25, 2015. The Act (Public Law 114-91) addressed problems related to prenatal opioid exposure and included several mandates for the U.S. Department of Health and Human Services (HHS). The law called for HHS to review planning and coordination of HHS activities related to prenatal opioid exposure and neonatal abstinence syndrome (NAS), which includes neonatal opioid withdrawal syndrome (NOWS), and to study and develop recommendations for the prevention, identification, and treatment of NAS as well as the treatment of opioid use disorder (OUD) in pregnant women. In May of 2017 HHS released a POIA strategy to address gaps in research, overlap of federal programs and coordination of federal efforts to address NAS and NOWS.

In addition, the Comprehensive Addiction and Recovery Act of 2016 (CARA) included a provision for the Government Accountability Office (GAO) to examine NAS in the United States and related treatment services for the condition. The GAO study was published in October, 2017 and found limited physical capacity to care for infants with NAS; limited coordination of care for mothers and infants with NAS; and gaps in research and data on NAS.

Finally, Section 7062 of the SUPPORT for Patients and Communities Act (P.L. 115-271, enacted October 24, 2018) requires a report about the implementation of the recommendations in the POIA strategy, to be submitted to specified congressional committees and made available to the public on the Department's website within 60 days of enactment.

In response to POIA, the GAO study, and the SUPPORT for Patients and Communities Act, HHS developed an implementation plan to inform planning and policy across the Department. Recommendations range from aspirational to practical and include preventing prenatal opioid exposure, providing evidence-based treatment for both mother and infant, increasing the accessibility of family-friendly services for pregnant and parenting women with OUD, supporting continuing education for healthcare providers, and determining optimal family and developmental support services for children who have experienced prenatal opioid exposure.

IMPLEMENTATION PLAN PURPOSE AND DEVELOPMENT PROCESS

In recognition of the need for an organizing framework to guide and track implementation of recommendations in the POIA Strategy, the HHS Behavioral Health Coordinating Council (BHCC) Opioid and Controlled Substances Subcommittee, NAS Workgroup developed this implementation work plan. This plan provides an update on the POIA implementation plan activities that are completed, in process, and planned by HHS agencies, targeting activities for research and evaluation, programs and services, data and surveillance, and education.

The development of the plan represents an iterative process with the first draft completed on March 30, 2018 and the final plan to be completed by September 1, 2018. HHS agencies updated their NAS-related activities in March, April, and August 2018.

IMPLEMENTATION PLAN PROGRESS

All POIA recommendations are being addressed by HHS, with the majority of recommendations being addressed through dedicated cross-agency collaboration. Of the 39 recommendations, the Administration for Children and Families (ACF) is addressing 15, the Agency for Healthcare Research and Quality (AHRQ) is addressing two, the Centers for Disease Control and Prevention (CDC) is addressing 26, the Centers for Medicare & Medicaid Services (CMS) is addressing 21, the Food and Drug Administration is addressing seven, the Health Resources and Services Administration (HRSA) is addressing 29, Indian Health Services (IHS) is addressing 29, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is addressing 14, the National Institute on Drug Abuse (NIDA) is addressing 18, HHS's Office of the Assistant Secretary for Health (OASH) is addressing 14, and the Substance Abuse and Mental Health Services Administration (SAMHSA) is addressing 25.

All agency activities are listed in the tables below. Updates are listed by recommendations, which in turn are organized into functional categories (Systemic, Clinical, Data and Surveillance, and Research and Evaluation).

Examples of Cross-Agency Collaboration

As highlighted above, the majority of recommendations are addressed through cross-agency collaboration with dedicated cross-agency activities for 36 of the 39 recommendations. For instance, ACF and SAMHSA jointly fund the National Center on Substance Abuse and Child Welfare (NCSACW) -- a technical assistance and training resource -- to improve family recovery, safety, and stability by advancing practices and collaboration among agencies, organizations, and courts working with families affected by substance use and co-occurring mental disorders and child abuse or neglect. ACF/Administration on Children, Youth and Families (ACYF) and SAMHSA also conducted a Policy Academy entitled "Improving Outcomes for Pregnant and Postpartum Women with Opioid Use Disorders, and their Infants and Families" on February 7-8, 2017, in Baltimore, MD to develop action plans on the complex needs of pregnant and parenting women. CMS and HRSA jointly issued guidance regarding Coverage of Maternal, Infant, and Early Childhood Home Visiting Services. NICHD (Office of the Director, Institutional Development Awards [IDeA] States Pediatric Clinical Trial Network) and NIDA partner on multiple research projects, including the "ACT NOW: Advancing Clinical Trials in NOWs" Initiative to evaluate treatment options and improve clinical care of infants with NAS. SAMHSA leads several joint efforts, including a work group entitled "Children and Families Impacted by the Opioid Crisis," a cross-agency collaboration with the Maternal and Child Health Bureau/HRSA, OASH/OWH, NIDA, and ACF in collaboration with CDC. OASH/OWH and IHS partnered to address opioid misuse among women of reproductive age in the American Indian/Alaskan Native (AI/AN) communities. OASH/OWH is also partnering with the HRSA Office of Women's Health on an initiative to produce a care coordination model for women impacted by opioids who receive healthcare services via HRSA-administered programs.

SUSTAINING HHS POIA IMPLEMENTATION PLAN EFFORTS

After the final implementation plan is approved, the BHCC Opioid and Controlled Substances Subcommittee will assume responsibility for the ongoing implementation and coordination of NAS and prenatal opioid exposure related activities to assess progress, evaluate effectiveness, and publicize NAS-specific programs and tools, contingent on funding.

IMPLEMENTATION STATUS OVERVIEW

The table below provides an overview of the recommendations by category, federal actions to address the recommendations, and funding and status for each action. The details of the implementation status for each recommendation is detailed in the following pages.

Recommendation Category	Number of Recommendations	Number of actions	Funding (Number of Actions | Percent of Actions)				Status (Number of Actions | Percent of Actions)
	39	423	Funded		Proposed/Contingent on Funding		Completed		Ongoing
Systemic Changes	16	198	164	82.82%	34	17.17%	8	4.04%	190	95.95%
Clinical Changes	7	90	79	87.77%	11	12.22%	9	10%	81	90%
Data and Surveillance Changes	5	55	36	65.45%	19	34.55%	0	0%	55	100%
Research and Evaluation Changes	11	80	57	71.25%	23	28.75%	9	11.25%	71	88.75%

IMPLEMENTATION STATUS BY RECOMMENDATION

Recommendations Addressing Systemic Changes

Recommendations addressed by the following agencies:

1. Increase access to the broad range of contraceptive options for women at risk of experiencing a substance-exposed pregnancy, including barrier free access to long-acting reversible contraception. (Programs & Services, Maternal)

1. CDC, CMS, HRSA, IHS

2. Provide ready access to effective SUD treatment, including tobacco cessation counseling/treatment, prior to conception and during pregnancy. (Programs & Services, Maternal)

1. CMS, FDA, HRSA, IHS, NIDA, OASH/OWH, SAMHSA

3. Make available family-friendly relapse prevention and recovery support for parents in recovery. (Programs & Services, Maternal)

1. ACF/Children's Bureau, CMS, HRSA, IHS

4. Provide ready access to family-friendly SUD treatment for parents. (Programs & Services, Maternal)

1. ACF/Children's Bureau, CMS, HRSA, IHS, SAMHSA

5. Provide ready access to parental support and early intervention services. (Programs & Services, Child)

1. ACF/Children's Bureau, CDC, CMS, HRSA, IHS, SAMHSA

6. Provide access to effective and alternative treatment options for pain prior to conception and during pregnancy and breastfeeding (Programs & Services, Maternal)

1. CDC, CMS, HRSA, IHS, NIDA

7. Promote general public awareness of the effectiveness of SUD treatment, to reduce barriers to seeking treatment prior to conception and in early pregnancy. (Education, Maternal)

1. ACF/Children's Bureau, CDC, CMS, FDA, HRSA, IHS, SAMHSA, OASH/OWH

8. Promote shift in public perceptions of SUD so that it is regarded as a disease rather than as a criminal or moral problem to reduce barriers to seeking treatment prior to conception and in early pregnancy. (Education, Maternal)

1. ACF/Children's Bureau, CMS, HRSA, IHS, NIDA, OASH/OWH, SAMHSA

9. Develop effective strategies to support informed decision making around pain management or SUD treatment when these conditions are identified prenatally. (Programs & Services, Maternal)

1. CDC, FDA, HRSA, IHS, OASH/OWH, SAMHSA

10. Promote non-pharmacologic interventions, such as rooming in, for managing mild to moderate NAS/NOWS. (Programs & Services, Child)

1. ACF/Children's Bureau, CDC, CMS, HRSA, IHS, NICHD, NIDA, SAMHSA

11. Promote breastfeeding for women who receive opioids for pain or the treatment of OUD when not otherwise contraindicated and consistent with appropriate guidelines. (Education, Maternal)

1. ACF/Children's Bureau, CDC, CMS, HRSA, IHS, OASH/OWH, SAMHSA

12. Promote breastfeeding of infants of women who receive opioids for pain or OUD when not otherwise contraindicated and consistent with appropriate guidelines. (Education, Maternal)

1. CDC, CMS, HRSA, IHS, NICHD, OASH/OWH, SAMHSA

13. Provide continuing medical education to the provider for managing pain in the pregnant woman with OUD. (Education, Maternal)

1. CDC, CMS, HRSA, IHS, SAMHSA

14. Provide continuing medical education to the provider for managing the infant with NAS symptoms. (Education, Maternal)

1. CDC, HRSA, IHS, OASH/OWH

15. Identify a history of prenatal substance exposure and NAS/NOWS when children receive developmental assessment, early intervention services or enter child welfare. (Data & Surveillance, Child)

1. ACF/Children's Bureau, CDC, CMS, HRSA, IHS

16. Promote public and health professional awareness of ongoing parental treatment engagement, recovery support, and early-intervention services in family function and mitigation of consequences of prenatal substance exposure and NAS/NOWS. (Education, Maternal)

1. ACF/Children's Bureau, CMS, FDA, HRSA, IHS, SAMHSA

Examples of agency activities to address recommendations:

*The hyperlinks allow readers to move to the next recommendation the specific agency addresses. For example, the first hyperlink for CDC takes the reader to recommendation #5, which is the next recommendation CDC addresses. The hyperlink for CDC in recommendation #5 then takes the reader to recommendation #6, the next recommendation CDC addresses; etc.

Recommendation	Agency	Action	Funding	Milestones/Status
1. Increase access to the broad range of contraceptive options for women at risk of experiencing a substance-exposed pregnancy, including barrier free access to long-acting reversible contraception. (Programs & Services, Maternal)	CDC (move to next CDC)	Funds the ASTHO Increasing Access to Contraception Learning Community which provides technical support and opportunities for peer-to-peer learning among states. Several states have shared models of linkage to care to increase access to the broad range of contraceptive options for women at risk of experiencing a substance-exposed pregnancy, including barrier free access to long-acting reversible contraception.	Funded	End date September 2018
		Continued efforts to provide technical support and opportunities for peer-to-peer learning among states to increase access to the broad range of contraceptive options for women at risk of experiencing a substance-exposed pregnancy.	Funded	End date September 2018
		Implement a Learning Community focused on supporting states as they implement policies and programs targeting identification and treatment of pregnant and postpartum women with OUD and infants with prenatal opioid exposure.	Funded	2018-2020
	CMS (move to next CMS)	Provided TA to states on improving access to the broad range of contraceptive options, but have not necessarily targeted that guidance to women at risk of experiencing a substance-exposed pregnancy. For example, CMS published a CMCS Informational Bulletin (CIB) on this topic: https://medicaid.gov/federal-policy-guidance/downloads/CIB040816.pdf.	Funded	4/08/2016
		Through the Maternal and Infant Health Initiative, CMS provides TA to states on a variety of quality improvement topics, including monitoring utilization the broad range of contraceptive care options. Monitoring utilization is necessary to identify where there are gaps in access and to help target effective interventions to increase access.	Provided by staff activities funded through internal FTEs	Ongoing
		Issued State Health Official letter #16-008. This letter discussed the family planning benefit and included the section, "Strategies for Improving Access to Long Acting Reversible Contraceptives (LARC)".	Funded	6/14/2016
		Provides TA to states as requested.	Funded	Ongoing
	HRSA (move to next HRSA)	Funds the Health Center Program supporting nearly 1,400 health centers that operate more than 11,000 service delivery sites in every state, DC, and U.S. territories. More than 27 million patients received accessible, affordable, high-quality primary health care services in 2017, including prenatal care for more than 573,000 pregnant women and delivery of more than 299,000 babies. Health centers provide care to patients with high prevalence of OUD or for those who are at risk for OUD, and health centers are required to provide obstetrics, gynecology, and voluntary family planning services.	Funded	Ongoing
		Funds the Healthy Start grant program which supports women before, during, and after pregnancy through the baby's second birthday by providing care coordination, health education, linkage to comprehensive health and social services, and engagement with community partners to enhance systems of care.	Funded	Ongoing
		Partners with the Federal Region 8 group (HRSA, OASH/Title X, and SAMHSA) to plan a project that will integrate respective agency programs and systems of care at the state level to increase access to services for women, including mental health, SUD treatment, primary care, and social service.	Funding TBD	To be implemented in 7-9 months
		Convenes events for stakeholders to share best practices and regional approaches. For example, Region 5 HRSA and OASH staff collaborated to hold a virtual meeting with state agencies to discuss prevention strategies, challenges, and opportunities for the regional OASH Prevention Collaborative to assist in addressing NAS.	TBD	On hold
	IHS (move to next IHS)	All IHS Facilities are required to maintain a broad range of prescription methods of contraception per the IHS National Core Formulary. LARC methods and other contraceptives are widely available to IHS patients with a provider trained to prescribe LARC method.	Funded	Ongoing
		Provides all IHS pharmacies with OTC emergency contraception. All IHS pharmacies Stock and dispense Emergency Contraception (OTC) upon patient request without a prescription.	Funded	Ongoing
		Plans to implement patient advertising surrounding use and availability of LARCs.	Funding TBD	To be implemented in 10-12 months
Recommendation	Agency	Action	Funding	Milestones/Status
2. Provide ready access to effective SUD treatment, including tobacco cessation counseling/treatment, prior to conception and during pregnancy. (Programs & Services, Maternal)	CMS move to next CMS)	Assesses Medicaid demonstrations for PPW with OUD and their newborns. Explores models of reimbursement that would incentivize provision of a broad range of treatment and recovery services to all Medicaid eligible PPW women, regardless of whether or not their infant receives an NAS diagnosis. Covers many services for pregnant women with OUD and infants affected by NAS, including medical, clinical, and SUD treatment services.	Funded	Ongoing
		Issued guidance to states on coverage of tobacco cessation counseling and treatment for pregnant women and has provided TA to states working to improve delivery of cessation services to pregnant women. "Tobacco Cessation -- Pregnancy" page on Medicaid.gov: https://www.medicaid.gov/medicaid/quality-of-care/improvement-initiatives/tobacco/pregnancy/index.html. Issued a State Medicaid Director Letter, #11-007, to implement section 4107 of the Affordable Care Act, which made tobacco cessation counseling and pharmacotherapy to pregnant women mandatory. The letter also provided information on reimbursement for administrative expenditures for "tobacco telephone quitlines." At last count (April 2017) there were 49 states with approved SPAs to implement comprehensive tobacco cessation coverage for pregnant women (including DC, Northern Mariana Islands, Puerto Rico, and the US Virgin Islands.) https://www.medicaid.gov/Federal-Policy-Guidance/downloads/SMD11-007.pdf.	Funded	Ongoing
		TA to states to improve delivery of cessation services to pregnant women continues to be available for states.	Funded	Completed
		Conducted a Medicaid IAP webinar highlighting NAS approaches in Medicaid: https://www.medicaid.gov/state-resource-center/innovation-accelerator-program/iap-downloads/20160313tlo12nas.pdf.	Funded	Completed
		Managed Care Regulations allow the option to continue Medicaid capitation payments to managed care plans that provide services through an IMD (and services to enrollees while they are patients in an IMD) in lieu of in-patient psychiatric or inpatient SUD services covered by Medicaid in other settings, subject to strict limitations (see 42 CFR 438.6(e)). Some states have enrolled pregnant women into managed care and, with the managed care flexibilities, been able to provide more treatment options than were otherwise available in the state plan. https://federalregister.gov/a/2016-09581	Funded	Ongoing
		Giving states flexibility to design section 1115 demonstrations to improve access to high quality, clinically appropriate treatment for OUD and other SUDs as discussed in the State Medicaid Director letter on "Strategies to Address the Opioid Epidemic" issued Nov. 1, 2017: https://www.medicaid.gov/federal-policy-guidance/downloads/smd17003.pdf	Funded	Ongoing
		Working with CMMI to develop a potential demonstration or model to improve access to treatment for pregnant women.	Funded	Ongoing
		Through IAP, CMS is supporting states to strengthen and improve their SUD delivery systems.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to provide access to effective SUD treatment.	Funded	Ongoing
	FDA (move to next FDA)	Ensures labels of products indicated for OUD emphasize weighing benefit of treatment versus risk of untreated OUD.	Funded	Ongoing
	HRSA (move to next HRSA)	Expands access to behavioral health screening and treatment in health centers and other primary care settings. Examples include: In September 2017, awarded $200 million to 1,178 health centers across the nation through the AIMS grant to add more behavioral health personnel, leverage health IT, provide training, and support the expansion of mental health services, SUD treatment, and their integration into primary care. In September 2018, awarded $352 million to 1,232 health centers across the nation through the Expanding Access to Quality Substance Use Disorder and Mental Health Services (SUD-MH) grant to expand access to SUD and mental health services. These funds will support health centers in implementing and advancing evidence-based strategies, including expanded MAT services. Provides the RHOP with approximately $2.5 million for 10 rural health organizations across nine states to help community members struggling with OUD find local treatment options and recovery support services through partnerships with local healthcare providers and other community-based groups. Supports testing evidence-informed interventions for integrating behavioral health with primary medical care for people living with HIV using an implementation science model to develop tools and resources to guide implementation locally at Ryan White HIV/AIDS Program provider sites. Convenes events for stakeholders to share best practices and regional approaches. For example, Region 5 HRSA and OASH staff collaborated to hold a virtual meeting with state agencies to discuss prevention strategies, challenges, and opportunities for the regional OASH Prevention Collaborative to assist in addressing NAS.	Funded	Ongoing
	IHS move to next IHS)	Provides tobacco cessation training for various healthcare disciplines (e.g., pharmacists, nurses) on universal tobacco use screening (Ask-Advise-Refer).	Funded	Ongoing
		Makes tobacco treatment services available in outpatient clinics with expanded access to OTC and prescription treatments for nicotine dependence.	Funded	Ongoing
		Makes counseling and support services available for pregnant women.	Funded	Ongoing
		Creates best practices recommendations to build treatment capacity and assist with early intervention and referral to treatment for OUD.	Funded	Ongoing
		Creates a series of webinars on trauma-informed care principles.	Funded	Ongoing
		Implements webinars to provide information on illicit substance use in pregnancy, opioid maintenance, and prevention strategies (to be revised to support new guideline implementation).	Funded	Ongoing
		Plans to publish on the Opioid Dependence Management public domain page and to provide trainings through the IHS TeleBehavioral Health Center of Excellence.	Proposed Funding TBD	Contingent on funding
	NIDA (move to next NIDA)	Funds research on effective treatments of any SUD, including smoking cessation in mothers during pregnancy. An example of recent efforts includes research on Cognitive-Affective Substrates of Smoking: Targets for Maternal Behavior Change.	Funded	Ongoing
		Continues to fund research to improve understanding of the most effective treatments before and during pregnancy in achieving abstinence.	Funded	Ongoing
	OASH (move to next OASH) OWH (move to next OWH)	Through the Office on Women's Health Prevention Awards (OWHPA) grants, awarded 6 out of the 20 grants organizations training health professionals using SBIRT. Grantees are in Regions 1, 2, 4, 5, and 7.	Funded via cooperative agreement for FY 17-FY19	Ongoing
		In March 2017, OASH/OWH initiated a 1-year partnership with IHS to support work to address the problem of opioid misuse among women of reproductive age in the AI/AN communities, including PPW. Specifically, the IAA supports	Funded via IAA and contract in FY17	Written recommendations will be released later in 2018 and will then be disseminated
		national training, education, and guidance through development of written recommendations on the screening, diagnosis, and management of opioid dependence among AI/AN women of reproductive age and AI/AN newborns. These documents are being developed with ACOG and the AAP.		throughout the IHS system (partnership with IHS and OASH/OWH)
		This IAA also supports the development of a structured, comprehensive approach to prenatal care and SUD treatment in Billings, MT, an area of particularly high need. This process has included extensive process mapping, and data collection has been conducted at two clinical sites (Lame Deer and Crow) clinics.	Funded via IAA and contract in FY17	Report will be released later in 2018 and will then be disseminated throughout the IHS system (partnership with IHS and OASH/OWH)
		In FY 2018, OASH/OWH is partnering with the HRSA Office of Women's Health on an initiative to produce a care coordination model for women impacted by opioids who receive healthcare services via HRSA-administered programs. This 2-year initiative will involve a two-phase series of working consultation meetings leading to a final guide that will include care coordination and implementation resources. Meetings will be held with stakeholders from all 10 HHS regions. OASH/OWH and HRSA will engage with regional staff to assist with follow-up consultation and foster sustainable partnerships generated during the meetings. Plans to develop and disseminate the care coordination models and resources.	Funded via IAA in FY18, FY19 funding TBD	FY18-20 (partnership between HRSA and OASH/OWH)
	SAMHSA (move to next SAMHSA)	Expanded the PPW program to three states to expand systems of care for PPW and their families (in 2017, MA, NY, and VA). In addition, 19 residential treatment providers received PPW grants to provide comprehensive SUD care for women and their children.	Grant funded (CARA)	FY17-FY22 and FY18-FY23
		Included a set-aside for PPW women's services in the SABG, which provides states with formula grants (noncompetitive grants based on a predetermined formula).	Grant funded (State Block Grant)	Ongoing
		Funded 14 states (AR, AZ, DE, FL, IN, KY, MA, ME, MS, MN, OH, TX, WV, and MT) through the Opioid State Targeted Response strategy to target pregnant women and their newborns.	Grant funded (21st Century Cures Act)	FY18, FY19 funding
		Provides MAT-PDOA funding to states to enhance and expand MAT and recovery support services for individuals with OUD. Three grantee states are focusing specifically on pregnant women with OUD (KY, LA, and MA).	Grant funded (21st Century Cures Act)	MAT-PDOA program: 8/1/2015-9/30/2020
Recommendation	Agency	Action	Funding	Milestones/Status
3. Make available family-friendly relapse prevention and recovery support for parents in recovery. (Programs & Services, Maternal)	ACF (move to next ACF) Office of Head Start (move to next OHS)	Early Head Start and Early Head Start-Child Care Partnerships, provide early, continuous, intensive, and comprehensive child development and family support services to low-income infants and toddlers and their families, and pregnant women and their families.	Funded	Ongoing
		Implements the Regional Partnership Grant Program. This program is designed to improve the well-being of children affected by parental substance abuse through the support of interagency collaborations and the integration of programs, services, and activities designed to increase the well-being, improve the permanency, and enhance the safety of children who are in, or at risk of, out-of-home placements as a result of a parent or caregiver's substance abuse. Of the program strategies and activities allowable under the grant program, include quality substance abuse treatment for parents and families that include access to comprehensive substance abuse treat programs where children can live on-site with mothers. The programs are designed to meet the needs of the entire family by providing access to MAT, trauma-specific services, and continuing care and recovery support. Funded the second cohort of these five-year grantees from 2012-2017 and had 17 grantees, a third cohort of 4 five-year grantees was funded in 2014, and grants will conclude in 2019. Continuing this critical work, in September 2017, the Children's Bureau funded the fourth cohort of 17 grantees for five years.	Grant funded	Ongoing; to be completed by 2022
	CMS move to next CMS)	See responses to number 2. Medicaid may reimburse certain services provided along a continuum of treatment for behavioral health conditions.	Funded	Ongoing
		CMS provides TA to states as requested.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to make available family-friendly relapse prevention and recovery support for parents in recovery.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA (move to next HRSA)	Expands access to behavioral health screening and treatment in health centers and other primary care settings. Examples include: In September 2017, awarded $200 million to 1,178 health centers across the nation through the AIMS grant to add behavioral health personnel, leveraged health IT, provided training, and supported the expansion of mental health services and SUD treatment and their integration into primary care. In September 2018, awarded $352 million to 1,232 health centers across the nation through the SUD-MH grant to expand access to SUD and mental health services. These funds will support health centers in implementing and advancing evidence-based strategies, including expanded MAT services. RHOP provides approximately $2.5 million for 10 rural health organizations across 9 states to help community members struggling with OUD find local treatment options and recovery support services through partnerships with local healthcare providers and other community-based groups. Supports testing evidence-informed interventions for integrating behavioral health with primary medical care for people living with HIV using an implementation science model to develop tools and resources to guide implementation locally at Ryan White HIV/AIDS Program provider sites. Convenes events for stakeholders to share best practices and regional approaches.	Funded	Ongoing
	IHS move to next IHS)	Several Indian healthcare Tribal programs have created perinatal substance use programs to include residential treatment programs as well as outpatient treatment models. Several best practice models are in place.	Funded	Ongoing
		Advocate for expansion of culturally appropriate prenatal care and SUD treatment models.	Funded	Ongoing
		IHS facilities promote comprehensive prenatal care that places an emphasis on screening, early detection, and referral to treatment for woman using opioid in pregnancy.	Funded	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
4. Provide ready access to family-friendly SUD treatment for parents. (Programs & Services, Maternal)	ACF move to next ACF) Children's Bureau move to next CB)	See #3 and #4.	Grant Funded	Ongoing; to be completed by 2022
	CMS move to next CMS)	See responses to #2 and #3.	Funded	Ongoing
		CMS provides TA to states as requested.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to make available family-friendly SUD treatment for parents.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
		States may request TA through the Medicaid IAP in developing proposals and implementation plans per the 1115 SUD opportunity described in State Medicaid Director Letter #17-003	Funded	Ongoing
	HRSA (move to next HRSA)	See #3. HRSA achieves this recommendation through health centers and other primary care settings.	Funded	Ongoing
	IHS move to next IHS)	Provides tobacco cessation training to various healthcare disciplines (e.g., pharmacists, nurses) on universal tobacco use screening (Ask-Advise-Refer).	Funded	Ongoing
		Makes tobacco treatment services available in outpatient clinics with expanded access to OTC and prescription treatments for nicotine dependence.	Funded	Ongoing
		Makes counseling and support services available to pregnant women. Best practices recommendations to build treatment capacity and assist with early intervention and referral to treatment for OUD. A webinar series on trauma-informed care principles.	Funded	Ongoing
		Provides webinars on illicit substance use in pregnancy, opioid maintenance, and prevention strategies (to be revised to support new guideline implementation).	Funded	12 months
		Plans to publish on the Opioid Dependence Management public domain page and to provide trainings through the IHS TeleBehavioral Health Center of Excellence.	Proposed funding TBD	Contingent on funding
	SAMHSA move to next SAMHSA)	Awarded 20 Family Drug Court grants in 2017 with a funding opportunity announcement for 2018 in development.	Grant funded	September 2017, 20 new FTDC grantees
		Required existing PPW Program activities to include relapse prevention and recovery support services for parents and other family members in recovery. Each project must demonstrate its capacity to carry out these services as part of the project design.	Grant funded (CARA)	FY17-FY22
		Expanded capacity in non-PPW treatment sites, where women with SUD also receive treatment services to provide prevention and recovery support services from a family-centered perspective.	Grant funded; ATTC's provide training and education to non-PPW treatment sites	2015 to present
		Ensured SABGs require that pregnant women receive preferential admission to SUD treatment and expenditures for women's services by each state in a given fiscal year must meet maintenance-of-effort requirements as a minimum.	Block Grant funded	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
5. Provide ready access to parental support and early intervention services. (Programs & Services, Child)	ACF move to next ACF) Office of Head Start move to next CDC)	Early Head Start and Early Head Start-Child Care Partnerships, provide early, continuous, intensive, and comprehensive child development and family support services to low-income infants and toddlers and their families, and pregnant women and their families.	Funded	Ongoing
		See #3, #4.	Grant funded	Ongoing; to be completed by 2022
	CDC move to next CDC)	Funds PQC of perinatal care providers and public health professionals working to improve pregnancy outcomes for women and newborns in states and nationally. Efforts include improving identification of and care for infants with NAS	Grant funded	Ongoing -- 2022
		CDC's Learn the Signs. Act Early. program aims to improve early identification of developmental delays and disabilities, so children and families can access early intervention and other support they need. The program offers free tools to help all parents and other caregivers learn the signs of healthy development, track their young child's developmental milestones, and act early if there is ever a developmental concern.	Funded	Ongoing
	CMS move to next CMS)	States are required to make available all medically necessary services found at section 1905(a) of the Social Security Act for children under age 21 in accordance with the EPSDT benefit, whether or not the treatment services are included in the state plan.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to provide ready access to parental support and early intervention services. Potential considerations include wrap-around and other integrated care strategies to support children and families.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA (move to next HRSA)	Convenes events for stakeholders to share best practices and regional approaches. For example, Region 5 HRSA and OASH staff collaborated to hold a virtual meeting with state agencies to discuss prevention strategies, challenges, and opportunities for the regional OASH Prevention Collaborative to assist in addressing NAS.	Funded	Ongoing
	IHS move to next IHS)	Adopted the Family Spirit curriculum.	Proposed funding	Ongoing
		Plans to expand peer recovery models.	Funding TBD	12 months
		Plans to expand screening and intervention recommendations based on emerging research.	Funding TBD	TBD
	SAMHSA move to next SAMHSA)	Project LAUNCH grantees implement a variety of parenting support evidence-based practices that are tailored to meet the specific population of the community. Many of these interventions focus on parenting and promotion of early life parent/child relationships. Project LAUNCH efforts also connect families and facilitate referrals to parenting support programs, including for caregivers with SUD and in recovery. LAUNCH grantees create pathways to early intervention services and have also focused on building the capacity of the early intervention workforce to better address the needs of families with SUD and children who have been impacted by parental SUD.	Grant funded	Ongoing; program began in FY08 and new cohort will be awarded in FY18
Recommendation	Agency	Action	Funding	Milestones/Status
6. Provide access to effective and alternative treatment options for pain prior to conception and during pregnancy and breastfeeding. (Programs & Services, Maternal)	CDC (move to next CDC)	CDC's Treating for Two initiative does not provide access to treatment options, but it works to identify the safest treatment options for the management of common conditions before and during pregnancy and to improve the availability and quality of data to help inform clinical management decisions for pregnant and reproductive-aged women and their healthcare providers. Treating for Two also conducts ongoing research and surveillance of medications commonly used to manage health conditions during pregnancy and associated adverse outcomes including structural birth defects.	Unfunded	Ongoing
	CMS move to next CMS)	Non-opioid, non-pharmacologic pain management therapies can be coverable under Medicaid state plan authority if they meet benefit requirements under 1905(a) of the Social Security Act.	Funded	Ongoing
		CMS provides TA to states as requested.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to provide access to effective and alternative treatment options for pain during pregnancy and breastfeeding.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA (move to next HRSA)	Through the AIM initiative, dozens of partners and experts developed a maternal safety bundle (best practices) for hospitals on the obstetric management of women with opioid dependence. Now 14 state-based teams and hospital systems are launching these best practices in hospitals and improving access to care for women and babies.	Funded	Ongoing
	IHS (move to next IHS)	Provides many alternative treatment options for pain control based on National Core Formulary and Patient Referred Services to external providers such as physical therapy. The Indian Health Manual Chronic Non-Cancer Pain Management Policy (IHM Chapter 30) includes strategies to reduce chronic opioid exposure and encourages alternative treatments. The IHS National Core Formulary includes several non-opioid medications and patients have access to additional non-opioid treatment modalities via Purchased Referred Care.	Funded	Ongoing
	NIDA move to next NIDA)	Funded research new approaches to reducing pain, prescription opioid use, and misuse in pregnancy.	Funded	Ongoing
		Continues funding for this research to increase available data and form recommendations.	Funded	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
7. Promote general public awareness of the effectiveness of SUD treatment, to reduce barriers to seeking treatment prior to conception and in early pregnancy. (Education, Maternal)	ACF (move to next ACF) Children's Bureau move to next CB)	NCSACW's mission is to improve family recovery, safety and stability by advancing practices and collaboration among, organizations and courts working with families affected by substance use and co-occurring mental health disorders and child abuse and neglect. The NCSACAW, including TA and initiatives described earlier in this document, the NCSCAW provides additional TA and resources to promote general public awareness of the effectiveness of SUD treatment to reduce barriers to seeking treatment prior to conception and in early pregnancy. These include: providing a variety of resources including publications, tutorials and webinar recordings to promote awareness; presenting at a variety of conferences throughout the year to a multidisciplinary group of professionals at both the national and state level; and actively engaging in the dissemination of the productions and publications they produce and have produced.	Funded via contract between ACF/SAMHSA	Ongoing
	CDC (move to next CDC)	Leading the Treating for Two initiative to identify the safest treatment options for the management of common conditions before and during pregnancy and to improve the availability and quality of data to help inform clinical management decisions for pregnant and reproductive aged women and their healthcare providers. Treating for Two also conducts ongoing research and surveillance of medications commonly used to manage health conditions during pregnancy and associated adverse outcomes including structural birth defects.	Unfunded	Ongoing
	FDA move to next FDA)	Makes announcements of approval of products for substance use treatment that are based on substantial evidence of effectiveness.	Funded	Ongoing
		Encourage development of products to treat SUD.	Funding TBD	Ongoing
	HRSA move to next HRSA)	Addresses this recommendation through a number of BH/SUD or cross-cutting programs mentioned above: The AIMS and SUD-MH supplemental funding for health centers, which encourage community engagement and education. AIM initiative RHOP Healthy Start Grant Program	Funded	Ongoing
		Funding Preventing Opioid Misuse in Pregnant Women & New Moms Challenge. HRSA is using prize competitions to encourage innovative solutions for improving the health of mothers and children across the U.S. This challenge seeks low-cost, scalable, technology solutions that will address barriers that limit access to quality treatment, care, and support services for those with OUD, including pregnant women and new moms.	Funded	Ongoing
	IHS move to next IHS)	Through IHS HOPE Committee, updates the Pain Management and Opioid Dependence Management websites to expand information surrounding SUD treatment and prevention. A Patient Information section for the general public is under development.	Funding TBD	Ongoing
		The IHS is in the process of creating a community and layperson MAT overview to introduce the public to general concepts such as what an opioid is, MAT, and the risks of perinatal substance use to reduce stigma surrounding MAT in tribal communities.	Funding TBD	12 months
		Is considering a digital story-telling initiative	Funding TBD	12 months
	SAMHSA move to next SAMHSA)	Co-leads an interdepartmental work group with HRSA and ACF titled Children and Families Impacted by the Opioid Crisis.	Federal effort- no funding required	Two work group meetings held
		Under the Project LAUNCH grant, grantees partner at the state level and community level to provide education and messaging regarding SUD treatment options and best practices for PPW. Dissemination efforts target primary care, home visiting, community services, community members and early care and education. While LAUNCH efforts do not focus exclusively on awareness and education about SUD, some grantees have embedded this into their efforts.	Grant funded	Ongoing; first cohort awarded in FY08; new cohort targeting AIAN communities will be awarded in FY18, date TBD
		Publishes a white paper through NCSACW and Court Professionals to identify the best treatment fit for families.	Contract funding	September 2018
		Identifies materials on the availability and importance of seeking treatment before and early in pregnancy and develops and distributes materials in partnership with the National Recovery Month Planning Partner's network.	Funded	Included in Recovery Month Toolkit 2018 (in progress) by June 2018
		Included information in the 2018 National Recovery Monthly toolkit targeting healthcare providers and highlighting the concept, "What You Can Do: Promoting General Public Awareness of the Effectives of SUD Treatment to Reduce Barriers to Seeking Treatment, Prior to Conception and in Early Pregnancy."	Funded	Included in Recovery Month Toolkit 2018 (in progress) by June 2018
	OASH (move to next OASH) OWH (move to next OWH)	In 2017, awarded 20 cooperative agreements on primary and/or secondary prevention of prescription and illegal opioid misuse by women across the lifespan to public and private nonprofit entities in 20 cities in 15 states. Funded projects were designed to promote and extend partnership and collaboration among state departments of health and other state, tribal, and local public health-focused entities; academic institutions; and private and public nonprofit and community organizations. Each entity has committed to substance abuse prevention and is working to improve the health and well-being of women and girls.	Funded via cooperative agreement for FY 17-FY19	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
8. Promote shift in public perceptions of SUD so that it is regarded as a disease rather than as a criminal or moral problem to reduce barriers to seeking treatment prior to conception and in early pregnancy. (Education, Maternal)	ACF (move to next ACF) Children's Bureau move to next CB)	NCSCAW provides a variety of TA activities and resources to promote general public awareness to education communities about SUDs and their treatment, including reducing barriers to seeking treatment prior to conception and in early pregnancy. In particular such efforts including a variety of online tutorials and curriculum designed to education various different professionals across disciplines, including those from child welfare and the courts about SUD and SUD treatment as well as other publications mentioned earlier including, A Collaborative Approach to the Treatment of Pregnant Women With Opioid Use Disorders: Practice and Policy Considerations for Child Welfare, Collaborating Medical, and Service Providers and the Executive Summary for SEI IDTA. In addition, related recent webinars include: Partnering to Support Families Affected by Opioid and Other Substance Use Disorders; Supporting Families in Child Welfare Affected by Opioid and Other Substance Use Disorders; A Framework for Intervention for Infants with Prenatal Exposure and Their Families; Early Identification and Treatment of Prenatally Exposed Infants; and Collaborative Approaches to Treating Pregnant Women with Opioid Use Disorders. Recordings and slides from these webinars can be found at: https://ncsacw.samhsa.gov/resources/videos-and-webinars/webinars.aspx.	Funded	Ongoing
	CMS move to next CMS)	CMS' Medicaid IAP held a learning opportunity for states specifically framing SUD as a chronic disease: https://www.medicaid.gov/state-resource-center/innovation-accelerator-program/iap-downloads/201506-hilc-webinar.pdf.	Funded	Completed
		Continuing to provide TA to states around SUD delivery reform.	Funded	Ongoing
	HRSA move to next HRSA)	The AIMS and SUD-MH supplemental funding for health centers, which encourage community engagement and education.	Funded	Ongoing
		Supports voluntary, evidence-based home visiting services for at-risk pregnant women and parents with young children up to kindergarten entry. Activities include: In FY17, the program provided training, TA, and resources to grantees on NAS. Training helps state programs use mental health consultation to improve home visitors' capacity to support families experiencing opioid use and caring for babies with NAS. During regional calls, states discuss NAS activities and share successful strategies. The program will release an issue brief highlighting state examples of effective home visiting practices and early childhood systems activities for families impacted by OUD. Several states have enhanced home visiting activities to address opioid use among families with young children.
		Addresses this recommendation through three programs mentioned above: Testing evidence-informed interventions for integrating behavioral health with primary medical care for people living with HIV AIM initiative RHOP	Funded	Ongoing (AIM to be completed 8/21/18)
		Sponsored at least two webinars on this topic that are targeted to Healthy Start and Home Visiting grantees. One addresses the unique issues related to pregnant women in tribal communities and common reasons they do not self-report substance use because of fear of child removal or legal action.	Funded	Ongoing
	IHS move to next IHS)	Developed seven-part series on perinatal substance use, treatment of opioid-exposed infants, culturally based treatment models/strategies, and overview of the IHS breastfeeding guideline.	Complete	Complete
		Through IHS HOPE Committee, continuously updates the Pain Management and Opioid Dependence Management websites and plans to expand access to SUD treatment and prevention. A Patient Information section for the general public is under development as are future updates to the websites.	Funding TBD	12 months
		Increases knowledge and skillsets of providers by continuing community education. A new curriculum will be created to support guideline implementation.	Funding TBD	12 months
	NIDA move to next NIDA)	Informs the public that SUD is a disease through outreach work on many agency levels.	Funded	Ongoing
		Continues to present public talks and publish about the disease of drug addiction.	Funded	Ongoing
	OASH move to next OASH) OWH move to next OWH)	In March 2017, OASH/OWH initiated a 1-year partnership with IHS to support work to address the problem of opioid misuse among women of reproductive age in the AI/AN communities, including PPW. Specifically, the IAA supports national training, education, and guidance through development of written recommendations on the screening, diagnosis, and management of opioid dependence among AI/AN women of reproductive age and AI/AN newborns. These documents are being developed with ACOG and the AAP.	Funded via IAA and contract in FY17	Written recommendations will be released later in 2018 and will then be disseminated throughout the IHS system.
		The IAA also supports the development of a structured, comprehensive approach to prenatal care and SUD treatment in Billings, MT, an area of particularly high need. Successful strategies developed in the Billings in this IAA will be leveraged across IHS.	Funded via IAA and contract in FY17	Report will be released later in 2018 and will then be disseminated throughout the IHS system.
	SAMHSA move to next SAMHSA)	Through multiple efforts conducted by CSAT/OCA, addresses the public perception of SUD as a treatable condition. Focused Recovery Month 2017 on families and community in recovery.	Funded	September 2017
		Worked with the PPW Program to identify evidence-based treatment programs for PPW who have had or are at risk of developing SUDs to use as case studies in the Road to Recovery TV and radio series.	Funded	April 2018
		Through CSAT/OCA's National Recovery Month observance/campaigns, addresses the issue of discriminatory practices toward those seeking SUD treatment or are in recovery from SUDs.	Funded	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
9. Develop effective strategies to support informed decision making around pain management or SUD treatment when these conditions are identified prenatally. (Programs & Services, Maternal)	CDC (move to next CDC)	Leading the Treating for Two initiative to identify the safest treatment options for the management of common conditions before and during pregnancy and to improve the availability and quality of data to help inform clinical management decisions for pregnant and reproductive aged women and their healthcare providers. Treating for Two also conducts ongoing research and surveillance of medications commonly used to manage health conditions during pregnancy and associated adverse outcomes including structural birth defects.	Unfunded	Ongoing
	FDA (move to next FDA)	Class labeling for immediate-release opioid analgesics.	Funded	Ongoing
		Participated in ongoing communications about abuse-deterrent formulations of opioids during all stages of the drug development process. There are currently eight approved opioid analgesic products with abuse-deterrent properties described in the product labeling.	Funded	Funded
	HRSA (move to next HRSA)	Achieves this recommendation through health centers and other primary care settings. Examples include: The AIMS and SUD-MH supplemental funding for health centers. RHOP	Funded	Ongoing
	IHS (move to next IHS)	Collaborates with external partners such as ACOG and the CONACH for development and implantation of guidelines for SUD and NOWS.	Funded	Ongoing
		Publishes best practices guidelines and recommendations on the Pain Management and IHS Opioid Dependence Management/Maternal Child Health websites; distributes information updates and resources through internal listserv domains.	Funded	Ongoing
	OASH (move to next OASH) OWH (move to next OWH)	The OASH/OWH and HRSA Office of Women's Health initiative to produce a care coordination model for women impacted by opioids who receive healthcare services via HRSA-administered programs may address this recommendation by implementing and disseminating models and resources, including pain management and opioid alternatives.	Funded via IAA in FY18, FY19 funding TBD	FY18-FY20
	SAMHSA (move to next SAMHSA)	AAP participated in the Technical Expert Panel addressing the Developmental Impacts on Children of Opioid Use in Pregnancy and will continue to partner to develop approaches to treatment for mothers and children affected by opioids.	Funded, future initiatives funding TBD	April 2018
Recommendation	Agency	Action	Funding	Milestones/Status
10. Promote non-pharmacologic interventions, such as rooming in, for managing mild to moderate NAS/NOWS. (Programs & Services, Child)	ACF (move to next ACF) Children's Bureau (move to next CB)	NCSACW is an HHS initiative jointly funded by SAMHSA CSAT and the ACF ACYF and OCAN. The mission of NCSACW is to improve family recovery, safety, and stability by advancing practices and collaboration among agencies, organizations and courts working with families affected by substance use and co-occurring mental health disorders and child abuse or neglect. NCSACW provide various forms of TA, including working with states to expand screening to identify women in need of brief intervention, and referral to treatment. Examples of the related TA they are providing include: Launched in September 2014, the SEI IDTA, which provides in depth TA to advance the capacity of tribes, states, and community agencies to improve the safety, health, permanency, and well-being of substance-exposed infants and the recovery of PPW and their families. The program is designed to strengthen collaboration among child welfare, substance use disorder treatment, and the courts, as well as medical communities, early care and education systems, home visiting, and other key partners. Six states were selected to participate in Round I (2014-2016) -- CT, KY MN, NJ, VA, and WV. Four of the states, CT, KY, NJ, and VA-- receive time-limited TA to develop policy and protocol on the prenatal substance exposure provisions in CAPTA. Currently, two states were selected to participate in Round II, including DE and NY and three additional states were selected to participate in Round III, including FL, MD and NC. ACF/ACYF/Children's Bureau and SAMHSA conducted a Policy Academy entitled "Improving Outcomes for Pregnant and Postpartum Women with Opioid Use Disorders, and their Infants and Families" on February 7-8, 2017, in Baltimore, MD. Ten states were selected to participate in the Policy Academy to develop action plans on the complex needs of pregnant and parenting women. The states included FL, GA, MD, MA, NY, MI, NC, PA, VT, and DE. NCSACW is providing support to the states to implement the action plans, many of which focus on the development and implementation of the CAPTA provisions.	Funded	Ongoing
		NCSACW created the publication, "A Collaborative Approach to the Treatment of Pregnant Women With Opioid Use Disorders: Practice and Policy Considerations for Child Welfare, Collaborating With Medical, and Service Providers". The document was downloaded from the NCSACW website 347 times during the first quarter. It was the most downloaded resource from the NCSACW website. Since its release in 2016, it has been downloaded 2,148 times.	Funded	Completed
	CDC (move to next CDC)	Funds the PQC which are networks of perinatal care providers and public health professionals working to improve pregnancy outcomes for women and newborns in states and nationally. Efforts include: improve identification of and care for infants with NAS.	Funded	Ongoing-2022
	CMS (move to next CMS)	Developed guidance regarding the critical role of Medicaid in the care of infants with NAS through an Informational Bulletin, "Neonatal Abstinence Syndrome: A Critical Role for Medicaid in the Care of Infants," at https://www.medicaid.gov/federal-policy-guidance/downloads/cib060818.pdf. This guidance includes a discussion of the professional recommendations for non-pharmacologic interventions as a first line treatment for mild to moderate NAS.	Funded	1-3 months
		Through the Medicaid IAP, CMS is supporting a cohort of states to assess the size and characteristics of NAS and opioid-related maternity care within the state's Medicaid program, including conducting data analytics on key population, utilization and expenditure patterns associated with NAS treatment.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to promote non-pharmacologic interventions, such as rooming in, for managing mild to moderate NAS/NOWS.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 month
	IHS (move to next IHS)	Ensures all IHS delivery facilities are Baby-Friendly certified. Baby-Friendly status includes high-level support for rooming-in, maternal-newborn bonding, and breastfeeding, all of which are helpful in the management of mild to moderate NOWS.	Funded	Ongoing
		Develops IHS initiatives on best practices guidelines on NOWS.	Funded	12 months
	NICHD (move to next NICHD)	Through NICHD and ECHO/ISPCTN programs, develops ACT NOW. The Second Act proposal includes research on non-pharmacologic interventions such as rooming-in and ESC comprehensive care strategies for treatment of NOWS versus usual care.	Funding	Under development
	NIDA (move to next NIDA) NICHD (move to next NICHD)	Published a notice of interest in February 2018 informing researchers of high programmatic priority to fund research on studies of non-pharmacologic interventions of NOWS.	Funding TBD	Ongoing
		Encourages and works with applicants in the development of research proposals addressing this high-priority area.	Funding TBD	TBD
	SAMHSA (move to next SAMHSA)	Initiates SAMHSA cross-agency collaboration with the Maternal and Child Health Bureau/HRSA, OASH/OWH, NIDA, and ACF.	Funded	Ongoing
		Engages with the NIDAMED and CDC and leverages SABG to pay for services in SUD facilities.	Funded	Ongoing
		Project LAUNCH: Education and trainings for medical professions and other child serving systems (such as child welfare or substance abuse treatment providers) related to management of NAS. Project LAUNCH grantees have the opportunity to educate all of these providers about best practices related to NAS, both in the hospital and post-discharge. Maine developed an innovative model (Bridging) for helping families before birth, shaping NICU practices, and reducing re-hospitalizations through post-discharge support to families related to NAS care and attachment. PA is developing training for home visitors, early intervention, and child welfare systems regarding best practices to managing NAS/NOWS and supporting of families experiencing the impacts of SUD.	Grant funded	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
11. Promote breastfeeding for women who receive opioids for pain or the treatment of OUD when not otherwise contraindicated and consistent with appropriate guidelines. (Education, Maternal)	ACF (move to next ACF) Children's Bureau (move to next CB)	See #10	Funded	Ongoing
	CDC (move to next CDC)	Has contracted with the ACOG to survey members about screening, referral, and treatment of maternal opioid use (including support of breastfeeding postpartum) and will produce a research report on survey results.	Funded	1 year
		Planning to collect information on hospital practices related to NAS infant (including breastfeeding) s with the mPINC survey (currently under OMB review). CDC will analyze data.	Funded	Ongoing; currently under OMB review
	CMS (move to next CMS)	Issued guidance regarding the critical role of Medicaid in the care of infants with NAS through an Informational Bulletin, "Neonatal Abstinence Syndrome: A Critical Role for Medicaid in the Care of Infants," at https://www.medicaid.gov/federal-policy-guidance/downloads/cib060818.pdf. This guidance includes a discussion of the recommendations for breastfeeding of infants with NAS by women if the women are enrolled in substance abuse treatment and no contraindications to breastfeeding are observed.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to promote breastfeeding for women who receive opioids for pain or the treatment of OUD when not otherwise contraindicated and consistent with appropriate guidelines.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA (move to next HRSA)	Several HRSA activities help address this recommendation, including: The evidence-based Home Visiting program.	Funded	Ongoing
	IHS (move to next IHS)	Through the AAP CONACH Guideline, has extensive recommendations on breastfeeding opioid-exposed infants.	Funded	Ongoing
		Has IHS Delivery Hospitals designated as Baby-Friendly institutions.	Funded	Ongoing
		Through GPRA measure, addresses total breastfeeding rates.	Funded	Ongoing
		Evaluates/leverages the Baby-Friendly initiative to increase breastfeeding rates where appropriate.	Funded	Ongoing
	OASH (move to next OASH) OWH (move to next OWH)	In March 2017, initiated a 1-year partnership with IHS to support work to address the problem of opioid misuse among women of reproductive age in the AI/AN communities, including PPW. Specifically, the IAA supports national training, education, and guidance through development of written recommendations on the screening, diagnosis, and management of opioid dependence among AI/AN women of reproductive age and AI/AN newborns. These documents are being developed with ACOG and the AAP.	Funded via IAA and contract in FY17.	Written recommendations will be released later in 2018 and will then be disseminated throughout the IHS system.
	SAMHSA (move to next SAMHSA)	SAMHSA's Office of the Chief Medical Officer is collaborating with ACOG, AAP, and other HHS partners. Participated in Workshop addressing SUDs in Pregnancy to develop guidance/publications for treating pregnant women with SUD/OUD. Will publish in American Journal of Obstetrics and Pediatrics.	Funded	January-February 2018
		Under the Project LAUNCH Grant: Education and trainings for medical professions and other child serving professionals (such as early intervention and child welfare agencies) related to best practices and research related to treatment of lactating women with OUD: Project LAUNCH grantees have the opportunity to educate all of these providers about best practices related to breastfeeding and OUD, NAS, etc. both in the hospital and post-discharge. SAMHSA Clinical Guidelines has been disseminated. Examples: Maine developed an innovative model (Bridging) for helping families before birth, shaping NICU practices, and reducing re-hospitalizations through post-discharge support to families related to NAS care and attachment. PA is developing training for home visitors, early intervention, and child welfare systems that will include guidance on breastfeeding and LAUNCH grantee is involved in the PA opioid efforts at the state level.	Grant funded	Ongoing; first cohort awarded in FY08; new cohort targeting AIAN communities will be awarded in FY18, date TBD
		Included SAMHSA official talking points in the spotlight segment in March and June 2018 Road to Recovery show.	Funded	March 2018
Recommendation	Agency	Action	Funding	Milestones/Status
12. Promote breastfeeding of infants of women who receive opioids for pain or OUD when not otherwise contraindicated and consistent with appropriate guidelines. (Education, Maternal)	CDC (move to next CDC)	Has contracted with ACOG to survey members about screening, referral, and treatment of maternal opioid use (including support of breast-feeding postpartum) and will produce a research report on survey results.	Funded	1 year
	CMS (move to next CMS)	Developed guidance regarding the critical role of Medicaid in the care of infants with NAS, through an Informational Bulletin, "Neonatal Abstinence Syndrome: A Critical Role for Medicaid in the Care of Infants," at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib060818.pdf. This guidance includes a discussion of the recommendations for breastfeeding of infants with NAS if the women are enrolled in substance abuse treatment and no contraindications to breastfeeding are observed.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to promote breastfeeding of infants of women who receive opioids for pain or OUD when not otherwise contraindicated and consistent with appropriate guidelines.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA (move to next HRSA)	Several HRSA activities help achieve this goal, including: The evidence-based Home Visiting program.	Funded	Ongoing
	IHS (move to next IHS)	Collaborates with the AAP CONACH to develop standardized screening guidelines based on the IHS Best Practice Guidelines: NOWS.	Funded	Ongoing
	NICHD (move to next NICHD)	Led an opioid use in pregnancy, NAS, and childhood outcomes workshop that was co-sponsored by ACOG, AAP, the Society for Maternal-Fetal Medicine, CDC, and the March of Dimes Foundation. The executive summary was published in Obstetrics and Gynecology June 2017 and reviewed the benefits of breastfeeding and the research agenda for breastfeeding.	Funded	Completed; summary/research agenda published June 2017
	OASH (move to next OASH) OWH (move to next OWH)	In March 2017, initiated a 1-year partnership with IHS to support work to address the problem of opioid misuse among women of reproductive age in the AI/AN communities, including PPW. Specifically, the IAA supports national training, education, and guidance through development of written recommendations on the screening, diagnosis, and management of opioid dependence among AI/AN women of reproductive age and AI/AN newborns. These documents are being developed with ACOG and the AAP.	Funded via IAA and contract in FY17	Written recommendations will be released later in 2018 and will then be disseminated throughout the IHS system.
	SAMHSA (move to next SAMHSA)	Project LAUNCH grantees have a wide reach into maternal and infant health serving systems and there are efforts and opportunities to provide information, awareness, and education around breastfeeding and other best clinical practices as they relate to breastfeeding, babies with NAS, and women with OUD.	Grant Funded	Ongoing; first cohort awarded in FY08; new cohort targeting AIAN communities will be awarded in FY18, date TBD
Recommendation	Agency	Action	Funding	Milestones/Status
13. Provide continuing medical education to the provider for managing pain in the pregnant woman with OUD. (Education, Maternal)	CDC (move to next CDC)	On August 16, 2016, hosted a Public Health Grand Round on "Primary Prevention and Public Health Strategies to Prevent Neonatal Abstinence Syndrome." (Ko JY, Wolicki S, Barfield WD, et al. CDC Grand Rounds: Public Health Strategies to Prevent Neonatal Abstinence Syndrome. MMWR Morb Mortal Wkly Rep 2017;66:242-245. DOI: dx.doi.org/10.15585/mmwr.mm6609a2)	Funded	August 2016
		CDC also has information and resources on the Treating for Two website that discuss the safety of medications used to treat pain during pregnancy and disseminates key findings on updated research through professional organizations for healthcare providers (e.g., ACOG, AAP).	Unfunded	Ongoing
		Has developed an online training for healthcare providers on opioids and pregnancy.	Funded	Ongoing
		Developing a module specific to pregnancy from the CDC Guideline for Prescribing Opioids for Chronic Pain to be released summer/fall 2018.	Funded	Ongoing
		On September 18, 2018, CDC hosted a Public Health Grand Round on "Emerging Threats to Pregnant Women and Infants" that included a presentation on surveillance to better understand the impact of the opioid crisis on infants (https://www.cdc.gov/grand-rounds/pp/2018/20180918-pregnancy-threats.html). A summary report is being drafted for publication.	Funded	September 2018
	HRSA (move to next HRSA)	Health Center Program supplemental funding through AIMS and SUD-MH may support continuing education for providers on SUD and mental health topics.	Funded	Ongoing
	IHS (move to next IHS)	Mandates 5-hour, web-based course on safe opioid prescribing and addiction treatment training for controlled substance prescribers spending greater than 50% of time in the federal government. The training module started in 2015 with refresher training required every 3 years.	Funded	Ongoing
	SAMHSA (move to next SAMHSA)	Collaborating with ACOG, AAP and other HHS partners and is working with CDC as lead using Providers Clinical Support System (PCSS)-MAT.	PCSS-MAT -- Funded; new initiatives as a result of collaboration; funding TBD	Ongoing
		Determines and hosts in one repository a CME courses on topics organized by content area (e.g., treating pain in pregnancy and special populations; treating OUD in pregnancy; treating substance-exposed infants).	Funded	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
14. Provide continuing medical education to the provider for managing the infant with NAS symptoms. (Education, Maternal)	CDC (move to next CDC)	Supports Grand Rounds and collaborations through the Treating for Two initiative.	Funded	Ongoing
	HRSA (move to next HRSA)	Health Center Program supplemental funding through AIMS and SUD-MH may support continuing education for providers on SUD and mental health topics.	Funded	Ongoing
		Supports the Children's Hospitals Graduate Medical Education Payment Program.	Funded	Ongoing
	IHS (move to next IHS)	Supports IHS Best Practices Guidelines: NOWS and other initiatives.	Funded	Ongoing
		Revising NOWS training curriculum to expand provider capacity.	Funding TBD	12 months
		Expand capacity for NOWS care at HIS Labor and Delivery hospitals to minimize the need for NICU transfer for cases of lower acuity.	Funding TBD	2 years
	OASH (move to next OASH) OWH (move to next OWH)	In March 2017, initiated a 1-year partnership with IHS to support work to address the problem of opioid misuse among women of reproductive age in the AI/AN communities, including PPW. Specifically, the IAA supports national training, education, and guidance through development of written recommendations on the screening, diagnosis, and management of opioid dependence among AI/AN women of reproductive age and AI/AN newborns. These documents are being developed with ACOG and the AAP.	Funded via IAA and contract in FY17	Written recommendations will be released later in 2018 and will then be disseminated throughout the IHS system.
Recommendation	Agency	Action	Funding	Milestones/Status
15. Identify a history of prenatal substance exposure and NAS/NOWS when children receive developmental assessment, early intervention services or enter child welfare. (Data & Surveillance, Child)	ACF (move to next ACF) Children's Bureau (move to next CB)	To support CAPTA and strengthen the implementation of Plans of Safe Care the Children's Bureau issued guidance on the administration of the CARA provisions relevant to the CAPTA State Grant though Information Memoranda ACYF-CB-IM-16-05 [https://www.acf.hhs.gov/cb/resource/im1605], Program Instruction ACYF-CB-PI-16-03 [https://www.acf.hhs.gov/cb/resource/pi1603] and Program Instruction ACYF-CB-PI-17-05 [https://www.acf.hhs.gov/sites/default/files/cb/pi1705.pdf]. States were required to provide an update on their activities to implement the provision, as amended by CARA, by June 30, 2017 as part of their submission of the Annual Progress and Services Report that addresses several grant programs funding child protection and child welfare services: SEI IDTA: NCSACW continues to provide IDTA focused on SEI in their new contract. The NCSACW will continue their work with states to help them respond to growing concerns about opioid use during pregnancy, the increasing number of infants with prenatal exposure, particularly those with NAS, and the lack of coordinated and ongoing services needed to support infants, families, and caregivers during the critical postpartum and infancy period. The initiative is focused on strengthening collaboration and linkages among child welfare, mental health and substance use treatment, public health and medical communities, home visiting and early intervention systems, and other key stakeholders to improve outcomes for infants with prenatal exposure, their mothers and families. TA Support to assist in the implementation of CARA: The NCSACW is tasked with providing two kinds of TA to directly support state implementation of the CAPTA requirements as it relates to the passage of CARA. The first task is to provide TA on an on-going basis to states and state organizations designated to implement the CAPTA requirements, including programmatic TA related to the development and implementation of Plans of Safe Care. TA will be tailored to specific state needs, as well as address the needs of all states when appropriate. TA may include responding to requests for information; disseminating written materials and resources, and conducting webinars/conference calls. The second task, to further assist in the successful implementation of CARA is CAPTA time-limited IDTA. This IDTA will be similar to other IDTA provided by the NCSACW, but on a time-limited basis. It will include the involvement of a Change Leader and may include a site visit. In addition, as necessary, TA tools may be developed and used to provide IDTA, as well as respond to other TA requests that come into NCSACW. These may include use of protocols, training plans, strategic plans, MOUs, etc. As well as other TA efforts by NCSACW outlined in response to recommendation #10.	Funded	Ongoing
	CDC (move to next CDC)	Provided funds to the March of Dimes to conduct a pilot project in Tennessee to link a cohort of infants identified with NAS through Medicaid claims data to Department of Education data to increase understanding of long-term neurodevelopmental outcomes potentially associated with NAS.	Funded co-agreement	Co-agreement to end June 2018
		Working with AAP on efforts to integrate assessment of prenatal alcohol exposure as routine primary pediatric practice.	Funded co-agreement	2014-2018
		Both surveillance of NAS and the Mother/Infant surveillance of sustained prenatal opioid exposure will prioritize the timely referral of families to needed services. We are still learning about possible long-term outcomes associated with prenatal opioid exposure during pregnancy. Limited research suggests that children with a history of NAS may be significantly more likely to have a disability, developmental delay, and speech or language impairment. Longer-term monitoring of these infants allows for appropriate referral to services to improve outcomes. Early intervention services can have a significant impact on a child's ability to learn new skills, overcome challenges and can increase success in school and life.	Funding TBD	Proposed/Contingent on funding
	CMS (move to next CMS)	Under the EPSDT benefit, Medicaid covers regular screening services for children under age 21 in order to identify health and developmental issues as early as possible. States must provide or arrange for screening services both at established times and on an as-needed basis. Covered screening services are medical, mental health, vision, hearing and dental. The medical screenings include, among other things, a comprehensive health and developmental history that assesses for both physical and mental health, as well as for substance use disorders.	Funded	Ongoing
		Provide TA to states as requested in implementing this requirement.	Funded	Ongoing
	HRSA (move to next HRSA)	Provided funds for Developmental-Behavioral Pediatrics Training Programs that provide training in developmental behavioral pediatrics and may include follow-up clinics for NICU patients and high-risk infants, which may include those with prenatal exposure to opioids.	Funded	Ongoing
		Provides Title V funds to all states. Funds may be used to implement screening for substance use among pregnant women, provider training, and care coordination.	Funded	Ongoing
		Achieves this recommendation through health centers and other primary care settings. Examples include: Behavioral Health Integration grant program awarded to community health centers, AIMS, and SUD-MH all support expansion of services and access, which include appropriate screening.	Funded	Ongoing
	IHS (move to next IHS)	Provides standard of care for IHS Pediatric departments.	Funded	Ongoing
		Operates early childhood intervention programs in tribal programs.	Funded (additional funding needed)	Ongoing
		Plans to work with Federal partners and professional organizations to develop formal recommendations surrounding early childhood interventions.	Funding TBD	2 years
Recommendation	Agency	Action	Funding	Milestones/Status
16. Promote public and health professional awareness of ongoing parental treatment engagement, recovery support, and early-intervention services in family function and mitigation of consequences of prenatal substance exposure and NAS/NOWS. (Education, Maternal)	ACF (move to next ACF) Children's Bureau (move to next CB)	See #7, #8, and #10.	Funded	Ongoing
	CMS (move to next CMS)	Developed guidance to states regarding the critical role of Medicaid in the care of infants with NAS, and issued an Informational Bulletin, "Neonatal Abstinence Syndrome: A Critical Role for Medicaid in the Care of Infants," at https://www.medicaid.gov/federal-policy-guidance/downloads/cib060818.pdf. This guidance includes a discussion of the important role mothers can play in treatment of the infants, as well as early intervention services available to Medicaid eligible infants after discharge from NAS treatment.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to promote public and health professional awareness of ongoing parental treatment engagement, recovery support, and early-intervention services in family function and mitigation of consequences of prenatal substance exposure and NAS/NOWS.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	FDA (move to next FDA)	FDA has approved products for the treatment of opioid overdose with prescribing information for use in neonates.	Funded	Ongoing
	HRSA (move to next HRSA)	HRSA addresses this recommendation through: Direct services programs such as Home Visiting Several clinical guidelines such as Bright Futures Health Supervision Guidelines for pediatric practice and the AIM initiative. Workforce development and training programs such as the National Health Service Corps, Public Health Training Centers, Teaching Health Center Graduate Medical Education, and Children's Hospitals Graduate Medical Education Payment Program. HRSA's Title V Maternal and Child Health Services Block Grant Program, which allows states the flexibility to support activities such as addressing NAS. Recent state examples include provider training; addressing the needs of pregnant women and their babies, including care coordination; using screening tools for early detection of high-risk women; and standardizing care for infants with NAS.	Funded	Ongoing
	IHS (move to next IHS)	Developed training on trauma-informed care and SUD in pregnancy.	Funded	Ongoing
		Developed and enhanced ongoing strategies and efforts in these areas based on emerging information and current standards of practice.	Funded	Ongoing
		Plans to increase number of trained peer recovery specialists.	Funding TBD	12 months
		Plans to advocate for increased access to intensive residential treatment and recovery housing (dependent on funding).	Funding TBD	Ongoing
		Advocates for increased access to MAT and withdrawal support services for women of childbearing age.	Funding TBD	12 months
	SAMHSA (move to next SAMHSA)	Held an expert panel meeting titled 'The Developmental Impacts on Children of Opioid Use During Pregnancy: Pragmatic Approaches to Support Children and Families' to discuss the state of the evidence on the impact of in utero opioid exposure on child development and identify protective/mitigating factors that can reduce or eliminate negative long-term impacts. As an outcome of the meeting, SAMHSA will develop a product that summarizes the literature and strategies from the meeting.	Contract funding	April 2018
		Create and improve linkages to early intervention services for families to mitigate impacts of prenatal exposure: Project LAUNCH grantees promote developmental and behavioral screening in childcare, pediatrics, and home visiting in order to promote early identification and intervention when developmental and behavioral issues emerge. In many communities, Project LAUNCH grantees provide developmental screening and assessment and have successfully increased and embedded behavioral screening and assessments in settings that do not specifically focus on young children such as child welfare. Grantees have also partnered with early intervention systems to build capacity around behavioral health. LAUNCH efforts also include parent engagement efforts across child serving systems and as part of system building.	Grant funded	Ongoing
		Supports Center of Excellence for Infant and Early Childhood Mental Health Consultation.	Funded	Ongoing
		Promotes awareness of early intervention services for families to mitigate impacts of prenatal exposure. The Center of Excellence will develop web materials and webinars in 2018 that prepare mental health consultants working in home visiting programs, childcare programs, and preschools to offer children, families, and caregivers strategies for effectively dealing with the consequences of prenatal exposure. These include behavioral strategies that promote healthy attachment, stable and nurturing caregiving, emotion regulation, and others.	Funded	Ongoing
		SAMHSA and ACYF jointly support NCSACW to identify appropriate training materials available through the NCSAW that can be used by state welfare and substance abuse treatment systems to improve outcomes for families with SUD.	Contract funding	Currently available and ongoing

Recommendations Addressing Clinical Changes

Recommendations addressed by the following agencies:

17. Improve and expand screening to identify women in need of brief intervention, and referral to treatment.(Data & Surveillance, Maternal)

1. ACF/Children's Bureau, AHRQ, CDC, CMS, HRSA, IHS, NIDA, OASH/OWH, SAMHSA

18. Define and understand the elements of an effective risk-benefit assessment in order to counsel pregnant women with pain regarding their management.(Data & Surveillance, Maternal)

1. CDC, IHS, NICHD, NIDA, OASH/OWH, SAMHSA

19. Expand the use of SBIRT to identify hazardous and harmful substance use and intervene to change behavior prior to conception. (Programs & Services, Maternal)

1. CDC, CMS, FDA, HRSA, IHS, OASH/OWH, SAMHSA

20. Support continuation of treatment for SUD from preconception through pregnancy and one year postpartum and tailor MAT according to parental need.(Programs & Services, Maternal)

1. CDC, CMSHRSA, OASH/OWH, SAMHSA

21. Provide easily accessible, family-friendly, SUD treatment for pregnant and parenting women.(Programs & Services, Maternal)

1. ACF/Children's Bureau, CMS, HRSA, IHS, NIDA

22. Provide developmental assessment and early intervention services for substance-exposed children with or without a history of NAS/NOWS.(Programs & Services, Child)

1. ACF/Children's Bureau, CDC, CMS, HRSA, IHS, SAMHSA

23. Promote training and resources for child welfare workers to effectively address SUD and prenatal substance exposure, facilitate linkages to treatment, and promote recovery for mothers with SUD.(Education, Child)

1. ACF/Children's Bureau, CDC, CMS, HRSA, IHS

Examples of Agency activities to address recommendations:

Recommendation	Agency	Action	Funding	Milestones/Status
17. Improve and expand screening to identify women in need of brief intervention, and referral to treatment.(Data & Surveillance, Maternal)	ACF (move to next ACF) Children's Bureau (move to next CB)	See #10.	Funded	Ongoing
	AHRQ (move to next AHRQ)	USPSTF is undertaking an evidence review to update clinical recommendations on "Screening for Illicit Drug Use in Adults and Adolescents." This review includes pregnant women.	Funded	Ongoing
	CDC (move to next CDC)	Funds PQCs which are networks of perinatal care providers and public health professionals working to improve pregnancy outcomes for women and newborns in states and nationally. Efforts include: improve identification of and care for infants with NAS.	Funded	Ongoing through 2022
		Provided grant funds for a research project to compare and validate screening tools for substance use among women. CDC has also contracted with ACOG to survey members about screening, referral, and treatment of maternal opioid use and will produce a research report on survey results.	Grant funded	Ongoing
		Continue efforts to provide ready access to parental support and early intervention services through the PQC.	Funded	Ongoing 2022
	CMS (move to next CMS)	As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to improve and expand screening to identify women with SUD and provide relevant referral to treatment.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA (move to next HRSA)	Provided funds for the Bright Futures Pediatric Implementation Program.	Funded	Ongoing
		AIMS and SUD-MH expand access to SBIRT and mental health screening at health centers.	Funded	Ongoing
		Specifically for PPW grantees in programs such as Healthy Start and Home Visiting, uses evidence-based approaches to screen, intervene, and refer perinatal women and parents of young children to treatment and recovery support services. Frontline staff provide health education and guidance for parents of young children, including caring for babies born with NAS.	Funded	Ongoing
		Supports the development of clinical guidelines such as Bright Futures Health Supervision Guidelines for pediatric practice and the AIM initiative, which developed best practices for hospitals on the obstetric management of women with opioid dependence.	Funded	Ongoing
		Provides all states with Title V funds that may be used to implement screening for substance use among pregnant women.	Funded	Ongoing
		Funds Healthy Start whose community health workers use standardized screening tools to screen and refer perinatal women for substance use.	Funded	Ongoing
	IHS (move to next IHS)	Collaborates with the ACOG's Committee on AI/AN Women's Health to develop and expand clinical practice guidelines to routinely screen women for SUDs and facilitate early referral to treatment.	Funded	All activities will be completed in 10-12 months
		Collaborates with the AAP CONACH to develop standardized screening guidelines based on the IHS Best Practice Guidelines: NOWS.	Funded	Ongoing
		Plans to implement approved guidelines and publish best practices recommendations on the IHS Opioid Dependence Management and Maternal Child Health webpages.	Funding TBD	12 months
		Plans to identify training needs to support implementation of guideline recommendations.	Funding TBD	12 months
		Plans to create and release outcomes measures to track implementation progress.	Funding TBD	12 months
	NIDA (move to next NIDA)	Funded research in the development of screeners to assess prescription drug abuse and other illicit drug use among pregnant women and identifying risk factors for prenatal substance and polysubstance use.	Funded	Results published 2018
		Plans to develop research in this area.	Funding TBD	TBD
	OASH (move to next OASH) OWH (move to next OWH)	Through OWHPA grants, awarded 6 out of the 20 grants to organizations training health professionals in using SBIRT. Grantees are in Regions 1, 2, 4, 5, and 7.	Funded via cooperative agreement for FY 17-FY19	Ongoing
		In March 2017, initiated a 1-year partnership with IHS to address the problem of opioid misuse among women of reproductive age in AI/AN communities, including PPW. Specifically, the IAA supports national training, education, and guidance through development of written recommendations on the screening, diagnosis, and management of opioid dependence among AI/AN women of reproductive age and AI/AN newborns. These documents are being developed through work with ACOG and AAP.	Funded via IAA and contract in FY17	Written recommendations will be released later in 2018 and will then be disseminated throughout the IHS system (partnership with IHS and OASH/OWH)
		Through the same IAA with IHS, OASH/OWH supported the development of a structured, comprehensive approach to prenatal care and SUD treatment in the Billings, MT, an area of particularly high need. This process has included extensive process mapping, and data collection has been conducted at two clinical sites (Lame Deer and Crow).	Funded via IAA and contract in FY17	Report will be released later in 2018 and will then be disseminated throughout the IHS system (partnership with IHS and OASH/OWH).
		In FY 2018, OASH/OWH is partnering with the HRSA Office of Women's Health on an initiative to produce a care coordination model for women impacted by opioids who receive healthcare services via HRSA-administered programs. This 2-year initiative will involve a two-phase series of working consultation meetings leading to the development of a final guide that will include care coordination and implementation resources. Meetings will be held with stakeholders from all 10 HHS regions. OASH/OWH and HRSA will engage with regional staff to assist with follow-up consultation and plans to develop and disseminate the care coordination models and resources.	Funded via AA in FY18, FY19 funding TBD	FY18-FY20 (partnership between HRSA and OASH/OWH)
	SAMHSA (move to next SAMHSA)	Working with ACOG and AAP to improve screening and care for women with OUD who are pregnant. ACOG issued guidance that all pregnant women be screened for SUD.	New initiatives funding TBD	Conversations/ collaboration initiated
		· Collaborated with the SAMHSA/HRSA Center for Integrated Health Solutions in the development of a webinar, "Screening Pregnant Women for SUD."	Funded	January 2018
		Project LAUNCH grant program: one core component of the LAUNCH model is to promote screening for children and their caregivers. Especially screening for behavioral health issues. LAUNCH grantees partner with existing systems that serve women and women with young children (home visiting; MCH; primary care/OB care; women, infants, and children; early intervention) and create mechanisms and opportunities to embed behavioral health screening and referral in those systems.	Grant funded	Ongoing; first cohort awarded in FY08; new cohort targeting AIAN communities will be awarded in FY18, date TBD
Recommendation	Agency	Action	Funding	Milestones/Status
18. Define and understand the elements of an effective risk-benefit assessment in order to counsel pregnant women with pain regarding their management. (Data & Surveillance, Maternal)	CDC (move to next CDC)	Leading the Treating for Two initiative to identify the safest treatment options for the management of common conditions before and during pregnancy and to improve the availability and quality of data to help inform clinical management decisions for pregnant and reproductive aged women and their healthcare providers. Treating for Two also conducts ongoing research and surveillance of medications commonly used to manage health conditions during pregnancy and associated adverse outcomes including structural birth defects.	Unfunded	Ongoing
		Published guidelines related to prescribing opioids for chronic pain, which included counseling pregnant women on opioid. (Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain -- United States, 2016. MMWR Recomm Rep 2016; 65(No. RR-1):1-49. DOI: dx.doi.org/10.15585/mmwr.rr6501e1 )	Funded	Published March 2016
		Has developed an online training for healthcare providers on opioids and pregnancy.	Funded	Ongoing
		Developing a module specific to pregnancy from the CDC Guideline for Prescribing Opioids for Chronic Pain to be released summer/fall 2018	Funded	Summer/Fall 2018
	IHS (move to next IHS)	Has instituted formal training in opioid prescribing for all physician staff prescribing narcotic pain medications.	Funded	10-12 months
		With AAP, CONACH, and ACOG, revises guidelines for managing addiction in pregnant women.	Funded	Ongoing
		Creates a training platform to educate providers on comprehensive pain assessment and treatment strategies in special populations to reduce NOWS risk	Funding TBD	Ongoing
	NIDA (move to next NIDA) NICHD (move to next NICHD)	Addresses opioid use in pregnancy, NAS, and childhood outcomes.	Ongoing	April 2016 meeting convened
		Published an executive summary on the research agenda in Obstetrics and Gynecology in June 2017.	Funded	Completed; summary/research agenda published June 2017
	OASH (move to next OASH) OWH (move to next OWH)	Focuses several OWHPA grants on risk-benefit assessment and counseling pregnant women on pain management. These grants are in Regions 1, 4, and 5.	Funded via cooperative agreement for FY 17-FY19	Ongoing
	SAMHSA (move to next SAMHSA)	Will convene an expert panel to discuss the available evidence on the long-term impact of in utero opioid exposure and the role of illicit or prescribed opioid exposure on child development.	Contract funding	April 2018
		Will develop a product that summarizes the literature and recommendations.	Contract funding	September 2018
Recommendation	Agency	Action	Funding	Milestones/Status
19. Expand the use of SBIRT to identify hazardous and harmful substance use and intervene to change behavior prior to conception.(Programs & Services, Maternal)	CDC (move to next CDC)	Supported FASD Practice and Implementation Centers (PICs) and National Partners to prevent FASDs by improving healthcare practice, education, and awareness among healthcare professionals through use of evidence-based practices, including alcohol screening and brief intervention. The PICs and National Partners worked with six health disciplines -- family medicine, medical assisting, nursing, obstetrics and gynecology, pediatrics, and social work. The goal of ongoing efforts is to impact healthcare practice at the systems level and enhance FASD prevention opportunities nationally for women of childbearing age and their support networks.	Funded co-agreement	Completed co-agreement: 2014-2018 Ongoing co-agreement: 2018-2022
		CDC and SAMHSA, in collaboration with the National Committee for Quality Assurance, are working to improve quality of care through alcohol screening and brief intervention and its reporting in electronic clinical data systems. This effort will promote a newly approved Healthcare Effectiveness Data and Information Set (HEDIS) performance measure, Unhealthy Alcohol Use Screening and Follow-Up. This work will be done through a quality improvement learning collaborative that will help health plans use and report the HEDIS measure in order to improve quality of care and health outcomes of individuals with unhealthy alcohol use.	Interagency agreement/ contract	2017-2020
	CMS (move to next CMS)	Issued CIBs entitled "Prevention and Early Identification of Mental Health and Substance Use Conditions": https://www.medicaid.gov/federal-policy-guidance/downloads/cib-03-27-2013.pdf and "Delivery Opportunities for Individuals with a Substance Use Disorder": https://www.medicaid.gov/Federal-Policy-Guidance/downloads/CIB-10-29-14.pdf.	Funded	Completed
		The 2017 State Medicaid Director letter establishes increased rates of identification, initiation and engagement in treatment as a goal of these demonstrations and states are expected to monitor progress on this goal. https://www.medicaid.gov/federal-policy-guidance/downloads/smd17003.pdf	Funded	Completed
		Providing TA to states as requested.	Funded	Ongoing
	HRSA (move to next HRSA)	Achieves this recommendation through health centers and other primary care settings. Examples include: AIMS and SUD-MH expand access to SBIRT and mental health screening at health centers. Funds support testing evidence-informed interventions for integrating behavioral health with primary medical care for people living with HIV and using an implementation science model to develop tools and resources to guide implementation locally at Ryan White HIV/AIDS Program provider sites.	Funded	Ongoing
	IHS (move to next IHS)	Plans to consider wide adoption of a Centering Pregnancy® program, which provides group prenatal care facilitated by a nurse midwife.	Funding TBD	10-12 months
		Captures screening and SBIRT initiatives in planned guidelines.	Funded	Ongoing
		Released GPRA SBIRT logic in baseline year; limitation is that this is captured for behavioral health patients.	Funded	Ongoing
	OASH (move to next OASH) OWH (move to next OWH)	A potential element of the OASH/OWH and HRSA Office of Women's Health initiative to produce a care coordination model for women impacted by opioids who receive healthcare services via HRSA-administered programs.	Funded via IAA in FY18, FY19 funding TBD	FY18-FY20
	SAMHSA (move to next SAMHSA)	Increased SBIRT use in the 2017 PPW cohort and other programs serving women of childbearing age and PPW populations.	Funded	Ongoing grant funded: 2017-2020
		· Cross-agency collaboration with CDC, HRSA, to expand SBIRT in women's healthcare settings. Quarterly calls to provide updates on programming.	New initiatives funding TBD	Ongoing
		Project LAUNCH states and communities promote and expand use of SBIRT, focusing on systems that serve pregnant women and parents of young children. Many grantees provide trainings on SBIRT and incorporate SBIRT into the array of services being provided through the grant	Grant funded	Ongoing; first cohort awarded in FY08; new cohort targeting AIAN communities will be awarded in FY18, date TBD
Recommendation	Agency	Action	Funding	Milestones/Status
20. Support continuation of treatment for SUD from preconception through pregnancy and one year postpartum and tailor MAT according to parental need.(Programs & Services, Maternal)	CDC (move to next CDC)	Has been working to improve the assessment of opioid and other SUD as a contributing factor in maternal deaths. State and local Maternal Mortality Review Committees (MMRCs) comprehensively assess maternal deaths and identify opportunities for prevention. To strengthen this work, CDC has partnered with the CDC Foundation and the Association of Maternal and Child Health Programs. MMRCs are in a unique position to identify and document the contribution of mental health conditions and substance use disorders (including opioid use disorders) to pregnancy-related mortality, because of their comprehensive and interdisciplinary approach. CDC is working with representatives of 25 MMRCs (AK, AZ, CO, DE, FL, GA, HI, IL, LA, MA, MS, MO, NH, NM, NYC, NC, OH, SC, TN, UT, VA, WA, WV, WI), to strengthen the capture of data related to substance use, including screening, diagnosis, referral, treatment, adherence, and the committees' determination of whether substance use disorder contributed to the death.	External funding (CDC Foundation from Merck for Mothers)	End date March 2019
		Build capacity of MMRCs in other states to improve data quality and data capture of the contribution of mental health and substance use disorders to maternal mortality.	External funding (CDC Foundation from Merck for Mothers)	End date March 2019
	CMS (move to next CMS)	See responses to #5. CMS makes information available on broad Medicaid coverage categories; states determine how to implement them consistent with Medicaid law and regulation and CMS approval when applicable.	Funded	Ongoing
		Provides TA to states as requested.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to support continuation of treatment for SUD throughout pregnancy and the postpartum period.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	Ongoing
	FDA (move to next FDA)	Labeling for MAT products notes the benefits of MAT treatment in pregnancy.	Funded	Ongoing
	HRSA (move to next HRSA)	Achieves this recommendation through health centers and other primary care settings. Examples include: The AIMS and SUD-MH supplemental funding for health centers. RHOP. Testing evidence-informed interventions for integrating behavioral health with primary medical care for people living with HIV.	Funded	Ongoing
	OASH (move to next OASH) OWH (move to next OWH)	A potential element of the OASH/OWH and HRSA Office of Women's Health initiative to produce a care coordination model for women impacted by opioids who receive healthcare services via HRSA-administered programs.	Funded via IAA in FY18, FY19 funding TBD	FY18-FY19
	SAMHSA (move to next SAMHSA)	Convened a Technical Expert Panel: Developmental Impacts on Children of Opioid Use During Pregnancy: Pragmatic Approaches to Supporting Children and Families. Will result in a product that describes the scientific literature on the impact of opioids in pregnancy, on the fetus/child, gaps future research should address, pragmatic approaches to supporting children/families impacted by opioid use in pregnancy.	Contract funding	April 2018
Recommendation	Agency	Action	Funding	Milestones/Status
21. Provide easily accessible, family-friendly, SUD treatment for pregnant and parenting women.(Programs & Services, Maternal)	ACF (move to next ACF) Children's Bureau (move to next CB)	See response to recommendation #3 regarding the Children Bureau's funding of the Regional Partnership Grant Program.	Grant funded	Ongoing; to be completed by 2022
	CMS (move to next CMS)	Works with states on section 1115 demonstrations to improve SUD treatment as well as use of the health homes authority to coordinate care for Medicaid beneficiaries with substance use disorder, which often include improving access to treatment in outpatient settings that are generally more accessible and family friendly.	Funded	Ongoing
		Provides TA to states as requested.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to provide easily accessible, family-friendly, SUD treatment for pregnant and parenting women.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA (move to next HRSA)	Achieves this recommendation through health centers and other primary care settings. Examples include: The AIMS and SUD-MH supplemental funding for health centers. The AIM initiative.	Ongoing	Ongoing
	IHS (move to next IHS)	Provides tobacco cessation training for various healthcare disciplines (e.g., pharmacists, nurses) on universal tobacco use screening (Ask-Advise-Refer).	Funded	Ongoing
		Makes tobacco treatment services available in outpatient clinics with expanded access to OTC and prescription treatments for nicotine dependence.	Funded	Ongoing
		Makes available counseling and support services for pregnant women in conjunction with tribal programs.	Funded	Ongoing
		Creates best practices recommendations to build treatment capacity and assist with early intervention and referral to treatment for OUD.	Funded	Ongoing
		Creates a series of webinars focused trauma-informed care principles.	Funded	Ongoing
		Provides webinars on illicit substance use in pregnancy, opioid maintenance, and prevention strategies (to be revised to support new guideline implementation).	Funding TBD	12 months
		Publishes on the Opioid Dependence Management public domain page and provides trainings through the IHS TeleBehavioral Health Center of Excellence.	Funded	Ongoing
	NIDA (move to next NIDA)	Funded research on improving access to treatment for women with OUD and risk assessment of NOWS.	Funded	Ongoing
		Continues funding for this research to increase available data and form recommendations.	Funded	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
22. Provide developmental assessment and early intervention services for substance-exposed children with or without a history of NAS/NOWS. (Programs & Services, Child)	ACF (move to next ACF) Officeof Head Start	Early Head Start and Early Head Start-Child Care Partnerships	Funded	Ongoing
		Also see #15.	Funded	Ongoing
	CDC (move to next CDC)	CDC's Learn the Signs. Act Early. program aims to improve early identification of developmental delays and disabilities, so children and families can access early intervention and other support they need. The program offers free tools to help all parents and other caregivers learn the signs of healthy development, track their young child's developmental milestones, and act early if there is ever a developmental concern.	Funded	Ongoing
	CMS (move to next CMS)	Under the EPSDT benefit, Medicaid covers regular screening services for children under age 21 in order to identify health and developmental issues as early as possible. States must provide or arrange for screening services both at established times and on an as-needed basis. Covered screening services are medical, mental health, vision, hearing and dental. The medical screenings include, among other things, a comprehensive health and developmental history that assesses for both physical and mental health, as well as for substance use disorders.	Funded	Ongoing
		CMS and HRSA have jointly issued guidance regarding Coverage of Maternal, Infant, and Early Childhood Home Visiting Services https://www.medicaid.gov/federal-policy-guidance/downloads/cib-03-02-16.pdf.	Funded	Completed 2016
		Core Set of Children's Health Care Quality Measures for Medicaid and CHIP (Child Core Set) includes the quality measure "Developmental Screening in the First Three Years of Life (DEV-CH). Results publicly reported for the first time for FFY 2016 and 27 states reported on the measure for FFY 2017.	Funded	Ongoing
	HRSA (move to next HRSA) ACF (move to next ACF)	Direct services programs such as Home Visiting and Healthy Start grant programs.	Funded	Ongoing
	HRSA (move to next HRSA) ACF (move to next ACF)	Jointly administer the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program to support parents of young children in at-risk communities. The program helps parents tap the resources and hone the skills they need to raise children who are physically, socially, and emotionally healthy and ready to learn.	Funded	Ongoing
	HRSA (move to next HRSA)	Provides funding to the Bright Futures Pediatric Implementation Program, which promotes developmental screenings at certain well-child visits (9 Month, 18 Month, and 2½ Year) and at other times at which concerns are identified.	Funded through cooperative agreement	Ongoing
	SAMHSA (move to next SAMHSA)	One of the core strategies of Project LAUNCH is to increase and improve access to developmental and social emotional screening for young children ages 0-8.	Grant funded	Ongoing; first cohort awarded in FY08; new cohort targeting AIAN communities will be awarded in FY18, date TBD
Recommendation	Agency	Action	Funding	Milestones/Status
23. Promote training and resources for child welfare workers to effectively address SUD and prenatal substance exposure, facilitate linkages to treatment, and promote recovery for mothers with SUD. (Education, Child)	ACF (move to next ACF) Children's Bureau (move to next CB)	See response to recommendations #7, #8, and #16 as it relates to the on-going work of NCSACW. Through this work, ACF is providing on-going TA to communities to promote and facilitate and strengthen collaboration between child welfare workers, facilitate linkages to treatment and promote recovery for mothers with SUD. NCSACW provides TA and four different levels to achieve these goals, in addition to the development of on-line training (which offers CEUs), curricula, webinars and other products to support our work in this area.	Contract funding	Ongoing
		Also see response to recommendations #3 as it relates to the work of the Regional Partnership Grant Program which specifically mentions the importance of cross-training and staff development as part of the work of these grants. Many of ACF's grantees include training child welfare staff as a part of their grant funded activities.	Grant funded	Ongoing; to be completed by 2022
	CDC (move to next CDC)	CDC is working with ACF to improve the health and developmental outcomes of children with prenatal substance exposures in the child welfare system by promoting appropriate identification, referrals, interventions and education. Working towards this objective will also 1) reduce the risk of repeated cycles of abuse/neglect and 2) build an infrastructure for monitoring the magnitude and resource needs for this population. The National Center on Substance Abuse and Child Welfare handles linking parents with child welfare involvement to treatment.	Interagency agreement	2016-2019
	CMS (move to next CMS)	As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to support community-level investments in improved infrastructure and resources to effectively address SUD and prenatal substance exposure, facilitate linkages to treatment, and promote recovery for mothers with SUD.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA (move to next HRSA)	Funds Evidence-Informed Practices in Home Visiting: Prevention, Identification, and Treatment of Substance Abuse in Families evaluation project. The goal is to develop a conceptual model for how MIECHV grantees can engage and support families at risk for, recovering from, or currently misusing substances, including opioids. If funded, a second phase will develop study design options to build out the model.	Funded	Ongoing
	IHS (move to next IHS)	Has developed a brochure on management of NOWS that has been used to educate child welfare workers on NOWS.	Funded	Ongoing
		Will support/augment training needs for tribal child welfare workers through development of a standardized curriculum (dependent on funding and available resources).	Funded	To be implemented in 10-12 months

Recommendations Addressing Data and Surveillance Changes

Recommendations addressed by the following agencies:

24. Standardize terminology and promote a unified approach to data collection and reporting in order to accurately quantify prenatal substance exposure and identify risk and protective factors amenable to preventive efforts.(Data & Surveillance, Child)

1. AHRQ, CDC, HRSA, IHS, SAMHSA

25. Collect substance- and diagnosis-specific data about prenatal substance use in order to develop adequate treatment capacity.(Data & Surveillance, Maternal)

1. CDC, CMS, HRSA, IHS, NIDA, OASH/OWH, SAMHSA

26. Establish clear definitions of NAS vs. NOWS and standardize the use of ICD codes in order to collect more meaningful and actionable data on the impact of prenatal substance exposure on infants and children.(Data & Surveillance, Child)

1. CDC, HRSA, IHS

27. Collect substance and diagnosis specific data about prenatal substance use in order to identify unmet service and care-coordination needs and any disparities in access.(Data & Surveillance, Maternal)

1. CMS, HRSA, SAMHSA

28. Collect data on the outcomes of substance exposed children who are removed from their families versus those remaining with a mother receiving supportive interventions.(Data & Surveillance, Child)

1. ACF/Children's Bureau, CDC, HRSA, NICHD, NIDA

Examples of Agency activities to address recommendations:

Recommendation	Agency	Action	Funding	Milestones/Status
24. Standardize terminology and promote a unified approach to data collection and reporting in order to accurately quantify prenatal substance exposure and identify risk and protective factors amenable to preventive efforts.(Data & Surveillance, Child)	AHRQ	Develops plan to use Health Cost and Utilization Project data to identify national or selected state-level trends in NAS diagnoses and prenatal exposures via maternal substance use. Work with HRSA and CDC to develop a standardized definition of NAS using ICD-10 codes. Evaluate the sensitivity and specificity of ICD-9-CM and ICD-10-CM codes for NAS specifications using the data from the Healthcare Cost Utilization Project. Document trends in NAS at national, regional, state and county level. Work with CEDC to examine hospitalizations for NAS-related birth defects. Examine factors associated with higher and lower county-level rates of NAS.	Funded	Ongoing
	CDC (move to next CDC)	Funded and provided TA to several state PQCs that are standardizing identification and data collection of NAS and validating ICD-10 NAS codes with hospital record data.	Funded	Ongoing
		Provides TA through MCH epidemiologists assigned to state health departments evaluating sensitivity and specificity of ICD-9 and ICD-10 NAS codes and working with CSTE to standardize NAS definitions and surveillance.	Funded	Ongoing
		The Treating for Two initiative tracks trends in prescription opioid use among pregnant and reproductive-age women to monitor the opioid epidemic and identify effective primary and secondary prevention strategies	Unfunded	Ongoing
		CDC is working with funded PQCs and CSTE to recommend a standardized surveillance definition for NAS.	Funded	Ongoing
		Aims to work with AHRQ and HRSA on analysis of NAS identified with ICD-10 codes.	Funding TBD	Proposed, contingent on funding
		Proposes leveraging the infrastructure of existing population-based birth defects surveillance programs to monitor the occurrence of NAS and any related birth defects.	Funding TBD	Proposed, contingent on funding
		Proposes leveraging the public health surveillance infrastructure of the US Zika Pregnancy and Infant Registry to monitor maternal, neonatal, and pediatric outcomes of infants following sustained prenatal exposure to opioids.	Funding TBD	Proposed, contingent on funding
		To help local health departments implement and/or improve surveillance of prenatal opioid exposure, CDC is adapting the Zika Local Health Department (LHD) Initiative and has placed a locally-hired contractual field assignee in Allegheny County, PA to build health department surge capacity where needed most. Learning from this model, we are extending the model via the OMNI Learning Community in up to 5 communities in 2019 and 2020 (See Recommendation #1).	Contract funding	Ongoing, 2016-2019; proposed, 2019-2020
		CDC is working with ACF to improve the health and developmental outcomes of children with prenatal substance exposures in the child welfare system by promoting appropriate identification, referrals, interventions and education. Working towards this objective will also 1) reduce the risk of repeated cycles of abuse/neglect and 2) build an infrastructure for monitoring the magnitude and resource needs for this population.	Funded co-agreement	2014-2019
		Working with AAP on efforts to integrate assessment of prenatal alcohol exposure as routine primary pediatric practice.	Funded	Ongoing
	HRSA (move to next HRSA)	Through the Fetal, Infant, Child Death Review Program, provides data collection, training, and TA to the more than 1,300 Child Death Review teams in the United States. Data provide descriptive information on child deaths related to suicide, serious mental illness, and opioid use.	Funded	FY18
	IHS (move to next IHS)	Standardizes terminology and conceptualization to NOWS from the previously universal terminology of NAS.	Funded	Ongoing
		Develops NOWS guideline including documentation recommendations and uniformed approach to infant assessments.	Funded	12 months
		Plans to adopt, distribute, and train on the IHS Best Practice Guidelines for NOWS.	Funded	12 months
		Considers applicability of holistic approaches and best practice recommendations included in NOWS guideline.	TBD	12 months
		Considers development of a survey to collect data from IHS Labor and Delivery Hospitals to improve care provision in these obstetrics units.	TBD	2 years
	SAMHSA (move to next SAMHSA)	Consults with subject matter experts in CDC, CMS, and other HHS agencies in consolidating validated measures/metrics to capture prenatal substance exposure.	Funded	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
25. Collect substance- and diagnosis-specific data about prenatal substance use in order to develop adequate treatment capacity.(Data & Surveillance, Maternal)	CDC (move to next CDC)	Leading the Treating for Two initiative to identify the safest treatment options for the management of common conditions before and during pregnancy and to improve the availability and quality of data to help inform clinical management decisions for pregnant and reproductive aged women and their healthcare providers. Treating for Two also conducts ongoing research and surveillance of medications commonly used to manage health conditions during pregnancy and associated adverse outcomes including structural birth defects.	Unfunded	Ongoing
		Provided funds for a PRAMS supplement that will allow selected states to collect data on maternal substance use.	Funded	PRAMS supplement to be completed 2018
		Provided funds in collaboration with the March of Dimes to conduct pilot projects on NAS leveraging the infrastructure of existing birth defects surveillance programs to better understand the incidence, severity, and long-term developmental and educational outcomes associated with NAS.	Funded co-agreement	NAS pilot projects to be completed June 2018
		In addition to the pilot projects designed to better understand NAS and inform the development of national NAS surveillance, CDC proposes to leverage the public health surveillance infrastructure of the US Zika Pregnancy and Infant Registry and of existing birth defects surveillance programs to monitor maternal, neonatal, and pediatric outcomes of infants following sustained prenatal exposure to opioids. Using this two-pronged approach to surveillance, CDC aims to understand the full scope of the opioid epidemic's impact on pregnant women and babies, in order to better address this growing public health concern and improve long-term health of mothers and babies.	Funding TBD	Proposed, contingent on funding
	CMS (move to next CMS)	Through the Medicaid IAP, CMS is supporting states to assess the size and characteristics of NAS and opioid-related maternity care within the state's Medicaid program, including conducting data analytics on key population, utilization and expenditure patterns associated with NAS. The aim of the NAS analytics under IAP is to help states understand where treatment occurs, what type of OUD maternity care and NAS treatment are utilized, and costs to Medicaid, in order to better inform data-driven strategies and support development of targeted interventions.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to collect substance- and diagnosis-specific data about prenatal substance use in order to develop adequate treatment capacity.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA(move to next HRSA)	Provides all states with Title V funds that may be used in data collection activities.	Funded	Ongoing
		Annually compiles and makes available national and state-level data on the proportion of infants born with NAS in partnership with CDC and AHRQ.	Funded	Ongoing
	IHS (move to next IHS)	Supports efforts to fix the IHS electronic medical record lack of sophistication to capture substance of use from a national perspective. There are SNOMED diagnostic barriers to capturing these data. IHS policy recommendations implemented at the local level should support this data collection.	Funding TBD	12 months
	NIDA (move to next NIDA)	Funded research to objectively determine which pregnant women should be administered buprenorphine.	Funded	Ongoing
		Plans to grow and develop research in this area.	Funding TBD	TBD
	OASH (move to next OASH) OWH (move to next OWH)	A potential element of the OASH/OWH and HRSA Office of Women's Health initiative to produce a care coordination model for women impacted by opioids who receive healthcare services via HRSA-administered programs.	Funded via IAA in FY18, FY19 funding TBD.	FY18-FY20
	SAMHSA (move to next SAMHSA)	Will conduct an evaluation of the PPW state pilot program that will identify unmet needs and barriers to meeting those needs, as well as strategies for meeting the needs.	Contract funding	2017-2020
Recommendation	Agency	Action	Funding	Milestones/Status
26. Establish clear definitions of NAS vs. NOWS and standardize the use of ICD codes in order to collect more meaningful and actionable data on the impact of prenatal substance exposure on infants and children. (Data & Surveillance, Child)	CDC (move to next CDC)	Provided funds and TA to several state PQCs that are engaged in standardizing identification and data collection of NAS and validating ICD-10 NAS codes with hospital record data.	Funded	Ongoing
		Provides TA through MCH Epidemiologists assigned to state health departments who are assisting with this work, evaluating sensitivity and specificity of ICD-9 and ICD-10 NAS codes	Funded	Ongoing
		Working with CSTE to standardize NAS definitions and surveillance.	Unfunded	Ongoing
		The Treating for Two initiative is tracking trends in prescription opioid use among pregnant and reproductive aged women to monitor the opioid epidemic and improve primary and secondary prevention efforts.	Unfunded	Ongoing
		Hopes to work with AHRQ and HRSA on analysis of NAS identified with ICD-10 codes.	TBD	TBD
		Proposes to leverage the public health surveillance infrastructure of a surveillance network (US Zika Pregnancy and Infant Registry) and existing birth defects surveillance systems to monitor maternal, neonatal, and pediatric outcomes of infants following sustained prenatal exposure to opioids. Using this two-pronged approach to surveillance, CDC aims to understand the full scope of the opioid epidemic's impact on pregnant women and babies, in order to better address this growing public health concern and improve long-term health of mothers and babies.	Funding TB	Proposed, contingent on funding
		To help local health departments implement and/or improve surveillance of prenatal opioid exposure, CDC is adapting the Zika Local Health Department (LHD) Initiative and has placed a locally-hired contractual field assignee in Allegheny County to build health department capacity where needed most. Learning from this model, we are extending the model via the OMNI Learning Community in up to 5 communities in 2019 and 2020 (See Recommendation #1).	Contract funding	Ongoing 2016-2019; proposed 2019-2020
		Through an interagency agreement, CDC is working with the ACF to improve the health and developmental outcomes of children with prenatal substance exposures in the child welfare system by promoting appropriate identification, referrals, interventions and education. Working towards this objective will also 1) reduce the risk of repeated cycles of abuse/neglect and 2) build an infrastructure for monitoring the magnitude and resource needs for this population.	Interagency agreement	2016-2018
		CDC is working with AAP on efforts to integrate assessment of prenatal alcohol exposure as routine primary pediatric practice.	Funded co-agreement	2014-2018
	HRSA (move to next HRSA)	Provides Title V funds to all states that may be used to standardize care for infants with NAS.	Funded	Ongoing
	IHS (move to next IHS)	Standardizes terminology and conceptualization of NOWS from the previously universal terminology of NAS.	Funded	Ongoing
		Develops NOWS guideline to include documentation recommendations and uniformed approach to infant assessments.	Funded	12 months
		Plans to adopt, distribute, and train on the IHS Best Practice Guidelines for NOWS.	Funded	12 months
		Considers applicability of holistic approaches and best practice recommendations included in NOWS guideline.	Funding TBD	12 months
		Considers development of a survey to collect data from IHS Labor and Delivery Hospitals to improve care provision in these OB units.	Funding TBD	2 years
Recommendation	Agency	Action	Funding	Milestones/Status
27. Collect substance and diagnosis specific data about prenatal substance use in order to identify unmet service and care-coordination needs and any disparities in access.(Data & Surveillance, Maternal)	CMS (move to next CMS)	Through the Medicaid IAP, CMS is supporting states to assess the size and characteristics of NAS and opioid-related maternity care within the state's Medicaid program, including conducting data analytics on key population, utilization and expenditure patterns associated with NAS. The aim of the NAS analytics under IAP is to help states understand where treatment occurs, what type of OUD maternity care and NAS treatment are utilized, and costs to Medicaid, in order to better inform data-driven strategies and support development of targeted interventions.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to collect substance and diagnosis specific data about prenatal substance use in order to identify unmet service and care-coordination needs and any disparities in access.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
	HRSA (move to next HRSA)	Provides Title V funds to all states that may be used in data collection activities.	Funded	Ongoing
		Annually compiles and makes available national and state-level data on the proportion of infants born with NAS in partnership with CDC and AHRQ.	Funded	Ongoing
	SAMHSA (move to next SAMHSA)	Conducts an evaluation of the PPW state pilot program that will identify unmet needs and barriers to meeting those needs, as well as strategies for meeting the needs.	Funded	2017-2020
Recommendation	Agency	Action	Funding	Milestones/Status
28. Collect data on the outcomes of substance exposed children who are removed from their families versus those remaining with a mother receiving supportive interventions. (Data & Surveillance, Child)	ACF (move to next ACF) Children's Bureau (move to next CB)	Sponsors the National Child Abuse and Neglect Data System, which collects data on substance-exposed infants, and the Adoption and Foster Care Analysis and Reporting System, which plans to collect information on whether "prenatal exposure" to alcohol or drugs contributes to the child being removed from the home.	Funded	Ongoing
		To implement the CARA amendments to CAPTA, WRMA, Inc., the contractor for NCANDS convened a volunteer working group of nine states to discuss and make recommendations of how to report the required data via NCANDS. The Children's Bureau and ACF Policy staff approved the provided decisions of how to report these data to NCANDS. In May 2017, NCANDS Technical Bulletin #9 was released to all states to provide guidance on data collection and reporting to comply with the CARA amendments to CAPTA. During August 2017, WRMA Inc. held a webinar with a focus on the CARA-related fields and during one-on-one TA provided to states during the fall of 2017, answered any questions from states about the CARA-related fields. During early 2018, states received specific guidance, instructions, definitions and data quality checks on how to report each CARA-related fields. States will begin reporting this data for FY18.	Contract funding	Ongoing
	CDC (move to next CDC)	Provided funds in collaboration with the March of Dimes to IL, NM, and VT to leverage the infrastructure of existing birth defects surveillance programs to conduct active surveillance of infants with NAS over a 1-year period, link vital statistics and hospital discharge data to follow these infants with NAS through age 1, and collect information on outcomes, including data on removal of child from the home following prenatal substance exposure.	Funded co-agreement	NAS pilot project to be completed June 2018
	HRSA (move to next HRSA)	Provides Title V funds to all states that may be used in data collection activities.	Funded	Ongoing
		HRSA annually compiles and makes available national and state-level data on the proportion of infants born with NAS in partnership with CDC and AHRQ.	Funded	Ongoing
	NICHD (move to next NICHD) NIDA move to next NIDA) ECHO (move to next ECHO)	Conducts ACT NOW: Advancing Clinical Trials in NOWs initiative, NOT-DA-17-067, Notice of Interest in Advancing Research about the Effects of Opioids and Opioid Antagonists on the Fetal and Neonatal Brain Development, jointly issued by NIDA and NICHD requests applications on this topic.	Funding TBD	TBD

Recommendations Addressing Research and Evaluation Changes

Recommendations addressed by the following agencies:

29. Determine the safety and effectiveness of naltrexone and naloxone when combined with buprenorphine use during pregnancy and breastfeeding.(Research & Evaluation, Maternal)

1. NICHD, NIDA, SAMHSA

30. Research consequences of unrelieved pain on women and their pregnancies.(Research & Evaluation, Maternal)

1. NICHD

31. Conduct research to support effective and safe non-opioid pharmacotherapy and non-pharmacologic pain relief strategies during pregnancy and breastfeeding.(Research & Evaluation, Child)

1. NICHD, NIDA

32. Develop easy to implement and valid screening instruments for SUD in pregnancy.(Data & Surveillance, Maternal)

1. CDC, HRSA, IHS, NIDA, OASH/OWH, SAMHSA

33. Research the modifiable maternal risk and protective factors and most effective interventions to minimize the impact of prenatal substance exposure on the fetus and child.(Research & Evaluation, Maternal)

1. CDC, NICHD, NIDA, SAMHSA

34. Study prenatal opioid treatment for pain and develop an objective risk-benefit analysis for providers and patients to use in making pain management decisions.(Research & Evaluation, Maternal)

1. CDC, FDA, IHS, NICHD

35. Research effective non-pharmacologic and non-opioid pharmacotherapies for pain management during pregnancy, labor and delivery, the postpartum care, and breastfeeding for women with chronic pain or OUD.(Research & Evaluation, Maternal)

1. NICHD, NIDA

36. Establish evidence-based protocols for identifying and managing NAS and NOWS.(Research & Evaluation, Child)

1. CDC, FDA, IHS, NICHD, NIDA, OASH/OWH, SAMHSA

37. Determine optimal toxicology screening of the opioid-exposed infant to support effective management with or without NAS/NOWS. (Research & Evaluation, Child)

1. IHS, NICHD, NIDA

38. Assess and determine optimal family and development support services for the child who experienced prenatal substance exposure or NAS/NOWS.(Research & Evaluation, Child)

1. ACF/Children's Bureau, CMS, HRSA, NICHD, NIDA, SAMHSA

39. Research the long-term developmental effects of prenatal substance exposure so that services can be developed to mitigate any effects. (Research & Evaluation, Child)

1. CDC, NICHD, NIDA, SAMHSA

Examples of Agency activities to address recommendations:

Recommendation	Agency	Action	Funding	Milestones/Status
29. Determine the safety and effectiveness of naltrexone and naloxone when combined with buprenorphine use during pregnancy and breastfeeding. (Research & Evaluation, Maternal)	NICHD (move to next NICHD)	Serves as a lead on the Opioid Use Disorder in Pregnancy (R01) RFA issued on September 25, 2017, which solicits grant applications on various topics including MAT.	Funded	Ongoing
		Along with NIDA, jointly issued NOT-DA-17-067, which covers MAT including naltrexone.	Funded	Ongoing
		Supports research to optimize buprenorphine dosing for pregnant women and reduce the risk of maternal relapse and neonatal opioid withdrawal syndrome. While this study does not specifically include naltrexone or naloxone, its dosing information is expected to inform future research on combination therapies.	Funding TBD	Ongoing
		Serves as lead on the proposed Prevention and Treatment of Opioid Use Disorders in Women of Reproductive Age initiative using 2019 funds.	Funding TBD	Proposed new activity 2019
	NIDA (move to next NIDA)	Funded research related to longitudinal neurobehavioral effects of buprenorphine and naloxone exposure on the developing fetus and newborn.	Funded	Ongoing
		Continues funding for this research.	Funded	TBD
	SAMHSA (move to next SAMHSA)	Held an expert panel meeting titled 'The Developmental Impacts on Children of Opioid Use During Pregnancy: Pragmatic Approaches to Support Children and Families' to discuss the state of the evidence on the impact of in utero opioid exposure on child development and identify protective/mitigating factors that can reduce or eliminate negative long-term impacts. As an outcome of the meeting, SAMHSA will develop a product that summarizes the literature and strategies from the meeting.	Contract funding	April 2018
Recommendation	Agency	Action	Funding	Milestones/Status
30. Research consequences of unrelieved pain on women and their pregnancies. (Research & Evaluation, Maternal)	NICHD (move to next NICHD)	Serves as a lead on the Opioid Use Disorder in Pregnancy (R01) RFA issued on September 25, 2017, which solicits grant applications on various topics including the effects of opioid agonist treatment on maternal, fetal, and neonatal outcomes.	Funded	Ongoing
		Along with NIDA, jointly issued NOT-DA-17-067, Notice of Interest in Advancing Research about the Effects of Opioids and Opioid Antagonists on the Fetal and Neonatal Brain Development, which studies antepartum and postpartum care and support for women with OUD.	Funded	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
31. Conduct research to support effective and safe non-opioid pharmacotherapy and non-pharmacologic pain relief strategies during pregnancy and breastfeeding. (Research & Evaluation, Child)	NICHD (move to next NICHD) NIDA (move to next NIDA)	Leads the proposal of an initiative "Prevention and Treatment of Opioid Use Disorders in Women of Reproductive Age" initiative using FY 2019 funds which would address research on non-pharmacologic/non-opioid therapies during pregnancy.	Funding TBD	If funded, initiative will be implemented 2019-2023; RFA funding starts 2018 and ends 2022
		Opioid Use Disorder in Pregnancy (RFA-HD-18-036) co-funded by NIDA. Topics for applications: Clinical studies of maternal medically-supervised opioid withdrawal examining maternal, fetal, and neonatal outcomes Observational or cohort studies evaluating the effects of opioid agonist treatment on maternal, fetal, and neonatal outcomes. This may include evaluation of fetal status and placental function. Pharmacokinetic and pharmacodynamic studies of medications used to treat opioid use disorder in pregnant and/or post-partum women Pharmacogenomic and other studies of genetic or epigenetic factors associated with the effects of opioid use during pregnancy on fetal and neonatal outcomes	Funding starts July 2018	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
32. Develop easy to implement and valid screening instruments for SUD in pregnancy. (Data & Surveillance, Maternal)	CDC (move to next CDC)	Provided grant funds for a research project to compare and validate screening tools for substance use among women.	Grant funded	FY18
	HRSA (move to next HRSA)	Through the AIM initiative, dozens of partners and experts developed a maternal safety bundle (best practices) for hospitals, on the obstetric management of women with opioid dependence. Now 14 state-based teams and hospital systems are engaged in launching these best practices in hospitals and improving access to care for women and babies.	Funded	8/2018
	IHS (move to next IHS)	IHS involvement with AAP, CONACH, and ACOG review of guidelines for managing addiction and pain in pregnant women.	Funded	To be implemented in 10-12 months
		Revisions to IHS Electronic Medical Record to capture 4Ps, DAST scores and CRAFFT scores.	Funding TBD	12 months
		CRS GPRA measure in discussion.	Funding TBD	TBD
		Development of training plan.	Funding TBD	TBD
	NIDA (move to next NIDA)	Funded research in providing treatment entry and family planning in substance-using NICU mothers.	Funded	Ongoing
		Evaluates current data of risk and protecting factors.	Funded	Ongoing
	OASH (move to next OASH) OWH (move to next OWH)	A potential element of the OASH/OWH and HRSA Office of Women's Health initiative to produce a care coordination model for women impacted by opioids who receive healthcare services via HRSA-administered programs.	Funded via IAA in FY18, FY19 funding TBD	FY18-FY20
	SAMHSA (move to next SAMHSA)	Advertise the SAMHSA "Substance Exposed Infants: State Responses to the Problem" document that includes a discussion of screening.	Funded	Completed February 2018
Recommendation	Agency	Action	Funding	Milestones/Status
33. Research the modifiable maternal risk and protective factors and most effective interventions to minimize the impact of prenatal substance exposure on the fetus and child. (Research & Evaluation, Maternal)	CDC (move to next CDC)	Provided funds for a PRAMS supplement that will allow selected states to collect data on maternal substance use. PRAMS data provides information on additional maternal behaviors and experiences before, during and after pregnancy.	Funded	PRAMS supplement to be completed 2018
		Provided funds in collaboration with the March of Dimes to conduct pilot projects on NAS to better understand the incidence, severity, and long-term developmental and educational outcomes associated with NAS.	Funded co-agreement	NAS pilot projects to be completed June 2018
		Leading the Treating for Two initiative to improve the availability and quality of data to help inform clinical management decisions for pregnant women and their healthcare providers.	Unfunded	Ongoing
		Proposes leveraging the public health surveillance infrastructure of the US Zika Pregnancy and Infant Registry and existing birth defects surveillance systems to monitor maternal, neonatal, and pediatric outcomes of infants following sustained prenatal exposure to opioids. A population with sustained prenatal opioid use that could be monitored is pregnant women on MAT (e.g. buprenorphine and methadone). Surveillance will increase understanding of co-factors that impact maternal and infant outcomes (e.g., nutrition status, other substance use, timing of treatment initiation in pregnancy) and also increase understanding of the longer-term outcomes of infants who experienced sustained prenatal exposure to opioids, including adverse outcomes among infants who both did and did not have NAS at birth.	TBD	Proposed, contingent on funding
		Has been monitoring alcohol use among women of reproductive age and related risk factors since the 1990s using the BRFSS and also have analyzed data from the National Survey of Family Growth which has questions on family planning, contraception, and related issues including alcohol use.	Funded	Ongoing
	NICHD (move to next NICHD)	Serves as a lead on the Opioid Use Disorder in Pregnancy (R01) RFA issued on September 25, 2017, which solicits grant applications on various topics including observational or cohort studies evaluating the effects of opioid agonist treatment on child outcomes including maternal risk and protective factors and evaluation of fetal status and placental function.	Funded	Ongoing
		Jointly with NIDA, issued NOT-DA-17-067, Notice of Interest in Advancing Research about the Effects of Opioids and Opioid Antagonists on the Fetal and Neonatal Brain Development, in which studies on this topic are requested.	Funded	Ongoing
		NICHD is also funding other research on neonatal opioid withdrawal syndrome. For example: NICHD is supporting the "Prevention of Neonatal Abstinence Syndrome" study, a clinical trial of administering ondansetron treatment (a broadly utilized drug with good safety record) to pregnant, opioid-using women just prior to delivery, followed by 3-day period of administration to neonate. Another study "A preventive pharmacotherapy for neonatal abstinence syndrome", is investigating a specific drug target to assess the feasibility of developing a new therapy to prevent opioid dependence in utero without interfering with management of maternal pain.	Funded	Ongoing
		In addition, NICHD is supporting research designed to optimize buprenorphine dosing for pregnant women, to reduce the risk of maternal relapse and neonatal opioid withdrawal syndrome.	Funded	Ongoing
	NIDA (move to next NIDA)	Funded research for treatment for mothers to minimize the effects of prenatal exposure on their infants.	Funded	Ongoing
		Continuation of funding for this research to improve treatment strategies which are most effective and safe for both mother and infant.	Funded	Ongoing
	SAMHSA (move to next SAMHSA)	Held an expert panel meeting titled 'The Developmental Impacts on Children of Opioid Use During Pregnancy: Pragmatic Approaches to Support Children and Families' to discuss the state of the evidence on the impact of in utero opioid exposure on child development and identify protective/mitigating factors that can reduce or eliminate negative long-term impacts. As an outcome of the meeting, SAMHSA will develop a product that summarizes the literature and strategies from the meeting.	Contract funding	April 2018
Recommendation	Agency	Action	Funding	Milestones/Status
34. Study prenatal opioid treatment for pain and develop an objective risk-benefit analysis for providers and patients to use in making pain management decisions. (Research & Evaluation, Maternal)	CDC (move to next CDC)	Leading the Treating for Two initiative to identify the safest treatment options for the management of common conditions before and during pregnancy and to improve the availability and quality of data to help inform clinical management decisions for pregnant and reproductive aged women and their healthcare providers. Treating for Two also conducts ongoing research and surveillance of medications commonly used to manage health conditions during pregnancy and associated adverse outcomes including structural birth defects.	Unfunded	Ongoing
	FDA (move to next FDA)	Led by the Division of Epidemiology, funded study of first-trimester exposure to opioids and neural tube defects.	Funded	Ongoing
	IHS (move to next IHS)	Develops best practices guidelines based on evidence-based practice and guidelines and conducts continued review of literature and guidelines and adapting accordingly.	Funded	Ongoing
	NICHD (move to next NICHD)	Leading the proposal of an initiative "Prevention and Treatment of Opioid Use Disorders in Women of Reproductive Age" initiative using FY 2019 funds.	Funding TBD	TBD
		Obstetric-Fetal Pharmacology Research Unit Network: PK/PD studies on buprenorphine (U54) to determine better way to dose based on objective and physiological parameters of satiety	Funded	6/1/2017-9/30/2019
Recommendation	Agency	Action	Funding	Milestones/Status
35. Research effective non-pharmacologic and non-opioid pharmacotherapies for pain management during pregnancy, labor and delivery, the postpartum care, and breastfeeding for women with chronic pain or OUD. (Research & Evaluation, Maternal)	NICHD (move to next NICHD)	Leading the proposal of an initiative "Prevention and Treatment of Opioid Use Disorders in Women of Reproductive Age" initiative using FY 2019 funds which would address research on non-pharmacologic/non-opioid therapies during pregnancy.	Funded	Ongoing
	NIDA (move to next NIDA)	Funded research in novel approaches to reduce pain, prescription opioid use and misuse in pregnancy.	Funded	Ongoing
		Planning to grow and develop research in this area.	Funding TBD	Ongoing
Recommendation	Agency	Action	Funding	Milestones/Status
36. Establish evidence-based protocols for identifying and managing NAS and NOWS. (Research & Evaluation, Child)	CDC (move to next CDC)	Funding 13 state Perinatal Quality Collaboratives of which nine are focused on improving care of women with opioid use disorder and infants with NAS including hospital practices related to management of NAS.	Funded	Ongoing through 2023
		Planning to collect information on hospital practices related to NAS infants with the mPINC survey.	Funded	Ongoing
		Proposes to leverage the public health surveillance infrastructure of the US Zika Pregnancy and Infant Registry and existing birth defects surveillance systems to monitor maternal, neonatal, and pediatric outcomes of infants following sustained prenatal exposure to opioids. Using this two-pronged approach to surveillance, CDC aims to understand the full scope of the opioid epidemic's impact on pregnant women and babies, in order to better address this growing public health concern and improve long-term health of mothers and babies.	Funding TBD	Proposed, contingent on funding
		CDC is working with funded PQCs and CSTE to recommend a standardized surveillance definition for NAS.	Unfunded	Ongoing
	FDA	Working with sponsors to develop treatments for managing NAS and NOWS	Funding TBD	Ongoing
	IHS (move to next IHS)	Standardizing terminology and conceptualization to NOWS from the previously universal terminology of NAS.	Funded	Ongoing
		Development of NOWS guideline to include documentation recommendations and uniformed approach to infant assessments.	Funded	12 months
		Distribution and training on the finalized IHS Agency approved guidelines.	Funded	12 months
	NICHD (move to next NICHD)	Neonatal Research Network site is funded to conduct two-year neurodevelopmental follow-up on infants with prenatal substance exposure.	Funded	Ongoing
	NICHD (move to next NICHD) NIDA move to next NIDA) ECHO (move to next ECHO)	NICHD/NIDA/ECHO have formed a partnership to conduct the "ACT NOW: Advancing Clinical Trials in NOWs" Initiative. The objective of this study is to merge the expertise of NICHD's NRN, which has over 30 years of experience in conducting clinical trials with newborns, and the ISPCTN within the ECHO Program Office to design and conduct a new study called the ACT NOWS to evaluate treatment options and improve clinical care of infants with NAS/NOWS. The goals of ACT-NOW are the following: Develop a survey to obtain information on the sites, local practices, demographics, and volume of patients affected with NOWs. Develop and conduct a retrospective study to obtain data to inform development of a clinical trial. Develop a common protocol(s) to generate evidence to inform best practice for identifying and managing NOWs.	Funded	Ongoing
	NIDA (move to next NIDA) NICHD (move to next NICHD)	NIDA and NICHD recently published a Notice of Interest for studies of methods for screening, identifying and assessing NOWs.	Funding TBD	Ongoing
	OASH OWH	In March 2017, initiated a 1-year partnership with IHS to support work to address the problem of opioid misuse among women of reproductive age in the AI/AN communities, including PPW. Specifically, the IAA supports national training, education, and guidance through development of written recommendations on the screening, diagnosis, and management of opioid dependence among AI/AN women of reproductive age and AI/AN newborns. These documents are being developed with ACOG and the AAP.	Funded via IAA and contract in FY17	Written recommendations will be released later in 2018 and will then be disseminated throughout the IHS system.
	SAMHSA (move to next SAMHSA)	Product titled 'Clinical Guidance for Treating Pregnant and Parenting Women With Opioid Use Disorder and Their Infants' developed and issued to the public.	Contract funding	February 2018
		Ancillary factsheets for patients and family members providing information about NAS/NOWS and treatment options are in the clearance process.	Contract funding	May 2018
Recommendation	Agency	Action	Funding	Milestones/Status
37. Determine optimal toxicology screening of the opioid-exposed infant to support effective management with or without NAS/NOWS. (Research & Evaluation, Child)	IHS	Infant screening recommendations included in AAP/CONACH Guideline.	Funded	To be implemented in 10-12 months
		UDS interpretation support may be needed.	Funding TBD	TBD
	NICHD (move to next NICHD) NIDA move to next NIDA) ECHO (move to next ECHO)	The NICHD/NIDA/ECHO partnership to conduct the "ACT NOW: Advancing Clinical Trials in NOWs" initiative will cover screening of the opioid -- exposed infant.	Funded	Ongoing
	NIDA (move to next NIDA) NICHD (move to next NICHD)	In collaboration with NICHD jointly issued NOT-DA-17-067, "Notice of Interest in Advancing Research about the Effects of Opioids and Opioid Antagonists on the Fetal and Neonatal Brain Development" to study the development of a biomarker that reflects physiologic state, lab on a chip for rapid screening, development of predictive assays for which babies will develop neonatal opioid withdrawal syndrome, require treatment and treatment response.	Funded	Ongoing
		Planning to grow and develop research in this area	Funding TBD	TBD
Recommendation	Agency	Action	Funding	Milestones/Status
38. Assess and determine optimal family and development support services for the child who experienced prenatal substance exposure or NAS/NOWS. (Research & Evaluation, Child)	ACF Children's Bureau	See #15.	Funded	Ongoing
	CMS	The EPSDT benefit requires states to assess and determine and to have available all medically necessary services for children under age 21 that are covered under the benefits at section 1905(a) of the Social Security Act. One of the covered benefits is case management under 1905(a)(19) of the Act. Under case management, a child would be assessed to determine the necessary services and would be able to receive those services to assist them in gaining access to needed medical, social, educational and other services.	Funded	Ongoing
		CMS and HRSA have jointly issued guidance regarding Coverage of Maternal, Infant, and Early Childhood Home Visiting Services which may help to assess and determine and address the need for family and development support. https://www.medicaid.gov/federal-policy-guidance/downloads/cib-03-02-16.pdf	Funded	Completed 2016
		Provide TA to states as requested in implementing this requirement.	Funded	Ongoing
		As a part of a multi-pronged strategy to combat the opioid crisis, some CMMI models being considered for potential development explore opportunities to evaluate potential optimal family and development support services for the child who experienced prenatal substance exposure or NAS/NOWS.	Potentially funded through Section 3021 (of the Affordable Care Act) Appropriation	10-12 months
		Potential efforts include identification of children's behavioral health and SUD issues, with the goal of connecting affected children to the appropriate community support services.		Ongoing
	HRSA	Funds an evaluation project called, Evidence-Informed Practices in Home Visiting: Prevention, Identification, and Treatment of Substance Abuse in Families. The goal is to develop a conceptual model for how MIECHV grantees can engage and support families at risk for, recovering from, or currently misusing substances, including opioids. If funded, a second phase will develop study design options to build out the model.	Funded	Ongoing
	NICHD (move to next NICHD) NIDA move to next NIDA) ECHO (move to next ECHO)	Research on this topic is being covered by the NICHD/NIDA/ECHO partnership to conduct the "ACT NOW: Advancing Clinical Trials in NOWs" initiative and NOT-DA-17-067, "Notice of Interest in Advancing Research about the Effects of Opioids and Opioid Antagonists on the Fetal and Neonatal Brain Development".	Funded	Ongoing
		NICHD and the ECHO program are leading the proposal of an initiative "ACT NOW: The Second Act" in which research on a cohort of infants exposed in-utero to opioids will study this particular topic.	Funding TBD	Under development
	NIDA (move to next NIDA) NICHD (move to next NICHD)	Recently published a Notice of Interest for studies of postpartum care and support for women with OUD to optimize maternal and neonatal outcomes. Studies of safe and effective outpatient management strategies for neonatal opioid withdrawal syndrome including optimal follow-up are also of high priority.	Funding TBD	Ongoing
		Continue to encourage the submission of grant applications addressing this research.	Ongoing	Ongoing
	SAMHSA (move to next SAMHSA)	Held an expert panel meeting titled 'The Developmental Impacts on Children of Opioid Use During Pregnancy: Pragmatic Approaches to Support Children and Families' to discuss the state of the evidence on the impact of in utero opioid exposure on child development and identify protective/mitigating factors that can reduce or eliminate negative long-term impacts. As an outcome of the meeting, SAMHSA will develop a product that summarizes the literature and strategies from the meeting.	Contract funding	April 2018
		Project LAUNCH help address coordination of services and in some cases, fund the provision of family interventions. Grantees also help facilitate referrals into early intervention and social emotional/mental health supports for children ages 0-8. Example: working with local child-serving systems to make sure that children at risk for developmental concerns are referred to EI or other supports early on and appropriately.	Grant funded	Ongoing; first cohort awarded in FY08; new cohort targeting AIAN communities will be awarded in FY18, date TBD
Recommendation	Agency	Action	Funding	Milestones/Status
39. Research the long-term developmental effects of prenatal substance exposure so that services can be developed to mitigate any effects. (Research & Evaluation, Child)	CDC	Provided funds in collaboration with the March of Dimes to conduct a small pilot project in Tennessee to link a cohort of infants identified with NAS through Medicaid claims data to Department of Education data in order to better understand the long-term neurodevelopmental outcomes potentially associated with NAS.	Funded co-agreement	Completed June 2018
		Monitor neonatal and pediatric outcomes of children with documented prenatal opioid exposure to increase understanding of co-factors that impact longer-term developmental outcomes of infants with prenatal exposure that may not have been diagnosed with NAS at birth.	Funding TBD	Proposed, contingent on funding
	NICHD (move to next NICHD) NIDA move to next NIDA) ECHO	This topic is being covered by the NICHD/NIDA/ECHO partnership to conduct the "ACT NOW: Advancing Clinical Trials in NOWs" initiative. NOT-DA-17-067, "Notice of Interest in Advancing Research about the Effects of Opioids and Opioid Antagonists on the Fetal and Neonatal Brain Development" which was jointly issued by NIDA and NICHD requests studies on this topic to be submitted.	Funded	Ongoing
		NICHD and the ECHO program are leading the proposal of an initiative "ACT NOW (Advancing Clinical Trials for Neonatal Opioid Withdrawal): The Second Act" in which research on a cohort of infants exposed in-utero to opioids will study the long-term developmental effects of prenatal opioid exposure.	Funding TBD	Under development
	NIDA NICHD	Encouraging research applications that examine the effect of severity of NOWS on brain, cognition, and behavior in neonates, adolescents, and adults.	Funding TBD	Ongoing
		Planning to continue research.	Funding TBD	Ongoing
	SAMHSA	Held an expert panel meeting titled 'The Developmental Impacts on Children of Opioid Use During Pregnancy: Pragmatic Approaches to Support Children and Families' to discuss the state of the evidence on the impact of in utero opioid exposure on child development and identify protective/mitigating factors that can reduce or eliminate negative long-term impacts. As an outcome of the meeting, SAMHSA will develop a product that summarizes the literature and strategies from the meeting.	Contract funding	April 2018

APPENDIX A. BHCC Opioid and Controlled Substances Subcommittee Members

Administration for Community Living

Keri Lipperini
Phantane Sprowls
Shannon Skowronski

Agency for Healthcare Research and Quality

Parivash Jourjah
Richard Ricciardi

Centers for Disease Control and Prevention

Farida Ahmad
Holly Hedegaard
LeShaundra Cordier
Margaret Warner
Rose Rudd
Sarah Bacon
Tamara Haegerich

Centers for Medicare & Medicaid Services

Adams Solola
Crystal High
Devon Trolley
Diane McNally
Elizabeth Goldstein
Joanne Hillborn
Joseph Fine
Kirsten Beronio
Laura Snyder
Mary Greene
Michael Forman
Pamela Schweitzer
Rena McClain
Rhepsie Christian
Shelby Kennedy
Victoria James
Wanda Pamphile
Yolanda Williams

Food and Drug Administration

Doug Throckmorton
Johanna McLatchy

Health Resources and Services Administration

Alexander Ross
Judith Steinberg
Karen Wade
Michelle Moses-Eisenstein
Shannon McDevitt

Immediate Office of the Secretary

Ben Shannon
Mona Siddiqui
Naweed Lamar
Shahla Jilani

Indian Health Service

Beverly Cotton
Cynthia Gunderson
Marcella Ronyak
Vanessa Thomas-Wilson

National Institute on Drug Abuse

Cheryl Boyce
David Thomas
Emily Einstein
Jack Stein
Jinhee Lee
Kelley Henry
Linda Porter
Maggie Stevenson
Nora Volkow -- Co-Chair
Wilson Compton

Office of the Assistant Secretary for Health

Alicia Richmond Scott
Anna Gribble
Clydette Powell
Corinna Dan
Cynthia Hansen
Dalton Paxman
Jessica Tytel (Office on Women's Health)
Joyce Yu
Juliet Bui
Michael Blodget
Nazleen Bharmal (Office of the Surgeon General)
Ndome Essoka
Rochelle Rollins
Ryan Moran

Office of the Assistant Secretary for Legislation

Alexandra Khalife
Sara Singleton

Office of the Assistant Secretary for Planning and Evaluation

Gavin Kennedy
Jessica (O'Hara) White
Laurel Fuller
Kristina West

Substance Abuse and Mental Health Services Administration

Audra Stock
Brandon Johnson
Christopher Jones -- Chair
Danielle Johnson
David deVoursney
Fran Harding
Greg Goldstein
Jeff Cody
Jennifer Fan
Jennifer Solomon
Jonaki Bose
Khadisha Johnson
Lisa Kaplowitz
Rebecca Flatow Zornick
Rob Lyerla
Sean Belouin
Shadia Garrison
Shahla Jilani
Steve Daviss
Tony Campbell

APPENDIX B. NAS Workgroup

Agency for Healthcare Research and Quality

Kamila Mistry

Administration for Children and Families

Elaine Stedt
Jean Blankenship

Centers for Disease Control and Prevention

Alex Ewling
Jean Ko
Jennifer Lind
Lisa Romero -- Subgroup Lead: Data and Surveillance
Meghan Frey

Centers for Medicare & Medicaid Services

Kirsten Beronio
Sandra Habit

Food and Drug Administration

Pamela Horn

Health Resources and Services Administration

Dawn Levinson -- Subgroup Lead: Programs and Services
Fraser Byrne
Sarah Sisaye
Judith Steinberg
Ashley Hirai

Indian Health Service

Cynthia Gunderson -- Lead: NAS Workgroup; Subgroup Lead: Education
Ted Hall -- Subgroup Lead: Education
Tyler Lannoye -- Subgroup Lead: Research and Evaluation

National Institute of Child Health and Human Development

Uma Reddy
Lisa Halvorson

National Institute on Drug Abuse

Emily Einstien
Karen Sirocco -- Subgroup Lead: Research and Evaluation

Office of the Assistant Secretary for Planning and Evaluation

Kristina West

Office of the Assistant Secretary for Health, Office on Women's Health

Jessica Tytel

Substance Abuse and Mental Health Services Administration

Audra Stock -- Lead: NAS Workgroup
Ekaterina Zoubak
Jennifer Oppenheim
Sharon Amatetti
Steve Daviss

NOTES

1. Vanderbilt University Medical Center Reporter. Study tracks impact of NAS on state Medicaid programs. (2018, March 23). Retrieved March 29, 2018, from https://news.vanderbilt.edu/2018/03/23/study-tracks-impact-of-nas-on-state-medicaid-programs.

2. Winkelman, T., N., A., Villapiano, N., Kozhimannil, K., B., Davis, M., & Patrick, S., W. (2018). Incidence and Costs of Neonatal Abstinence Syndrome Among Infants With Medicaid: 2004-2014. Pediatrics, 141(4):e20173520.