[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Notices]
[Pages 24137-24138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10735]



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DEPARTMENT OF HEALTH AND HUMAN SERVICE

Substance Abuse and Mental Health Services Administration


Protecting Our Infants Act Report to Congress: Summary of Public 
Comment and Final Strategy

AGENCY: Substance Abuse and Mental Health Services Administration 
(SAMHSA), Department of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) in the Department of Health and Human Services (HHS) announces 
the release of the ``Protecting Our Infants Act: Final Strategy'' in 
response to sections 3(a)(2) and 3(b) of the Protecting Our Infants Act 
of 2015 (POIA). The POIA mandated HHS to: conduct a review of planning 
and coordination activities related to prenatal opioid exposure and 
neonatal abstinence syndrome; develop recommendations for the 
identification, prevention, and treatment of prenatal opioid exposure 
and neonatal abstinence syndrome; and develop a strategy to address 
gaps, overlap, and duplication among Federal programs and Federal 
coordination efforts to address neonatal abstinence syndrome. The 
Protecting Our Infants Act: Report to Congress which satisfied these 
requirement was made available January 17, 2017, through February 21, 
2017, for public comment in the following docket SAMHSA-2016-0004-0001. 
As a result of the public comments, summarized below, several 
recommendations were added to the original strategy and others 
expanded. The Final Strategy can be read and downloaded at https://www.samhsa.gov/specific-populations/age-gender-based#poia.

FOR FURTHER INFORMATION CONTACT:  Melinda Campopiano, MD, Chief Medical 
Officer, Center for Substance Abuse Treatment, Substance Abuse and 
Mental Health Services Administration, 5600 Fishers Lane, 13E49, 
Rockville, MD, 20852. Email: [email protected]. Phone: 
(240)276-2701

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments, 
including any personally identifiable or confidential business 
information that is included in a comment, received during the comment 
period are available for viewing by the public in the public docket.
    Background: The POIA mandated HHS to: (1) conduct a review of 
planning and coordination activities related to prenatal opioid 
exposure and neonatal abstinence syndrome (Section 2(a) of the Act); 
(2) develop recommendations for the identification, prevention, and 
treatment of prenatal opioid exposure and neonatal abstinence syndrome 
(Section 3 of the Act); and (3) develop a strategy to address gaps, 
overlap, and duplication among Federal programs and Federal 
coordination efforts to address neonatal abstinence syndrome (Section 
2(b) of the Act). The POIA is available at: https://www.congress.gov/114/plaws/publ91/PLAW-114publ91.pdf.
    In response to the requirements of the POIA, ``The Protecting Our 
Infants Act: Report to Congress'' was released January 17, 2017. The 
report provided background information on prenatal opioid exposure and 
neonatal abstinence syndrome (Part 1), summarized HHS activities 
related to prenatal opioid exposure and neonatal abstinence syndrome 
(Part 2), presented clinical and programmatic evidence and 
recommendations for preventing and treating neonatal abstinence 
syndrome (Part 3), and presented a strategy to address the identified 
gaps, challenges, and recommendations (Part 4).
    As required in Section 2(b) of POIA, public comment was sought on 
``Part 4: Strategy to Protect Our Infants.'' All comments, including 
any personally identifiable or confidential business information that 
is included in a comment, received during the comment period are 
available for viewing by the public in this docket. The comments and 
corresponding changes to the strategy are summarized in this notice, 
below. The Protecting Our Infants Act: Final Strategy can be read and 
downloaded at https://www.samhsa.gov/specific-populations/age-gender-based#poia.
    Summary of Public Comment: A total of 22 comments were received. 
The majority were both favorable and relevant. This is a summary of the 
relevant public comments. It is organized according to the same three 
sections included in Part 4 of the report: Prevention, Treatment, and 
Services. It also includes a brief section in which global comments are 
reviewed. Examples of comments outside the scope of the original FRN 
that are not included in this summary, include discussion of: The 
statute itself, current unresolved policy issues related to health care 
access, decriminalization of drug use, specific state policies or laws 
outside the purview of the federal government, and comments on sections 
of the report other than the strategy.

Prevention

    Prevention-related comments were received on the topic of pain 
management. These comments urged that education and awareness efforts 
address opportunities to prevent and treat pain in preconception and 
pregnancy. Commenters pointed out that the same types of barriers, such 
as coverage limits and requirements for prior authorization that impede 
access to substance use disorder treatment, also limit access to 
alternative treatments for pain. The wider use of these alternatives 
may ultimately reduce the numbers of opioid-exposed pregnancies and 
neonatal opioid withdrawal syndrome (NOWS). The following language was 
added to the programs and services section of the prevention strategy 
(Table 11 of the final strategy) to address this comment: ``Provide 
access to effective and alternative treatment options for pain prior to 
conception and during pregnancy and breastfeeding.''
    One comment urged exploration of primary prevention strategies of 
benefit to women and infants at risk for NOWS and described important 
elements of primary prevention strategies such as social determinants 
of health, opioid prescribing practices, the need for care coordination 
and increased capacity for behavioral, general medical, and gynecologic 
health services. Language corresponding to this comment was not added 
to the strategy because these comments, while relevant to opioid use 
disorder (OUD) in general, are not directly related to opioid use 
during pregnancy. Suggestions were provided on ways to strengthen data 
collection and close existing gaps. Language capturing these 
suggestions was not added to the document because similar activities 
are currently underway within HHS, as described in Part 2 of the 
report.

Treatment

    Comments with regard to treatment urged that comprehensive, 
integrated services be emphasized, that services such as smoking 
cessation be tailored to pregnant women, and that all substance use 
disorder (SUD) treatment continue for one year postpartum. The words 
``from preconception through pregnancy and one year postpartum'' were 
added to a recommendation in the programs and services section of the 
treatment strategy (Table 12 of the final strategy) to reflect these 
comments. The recommendation now reads: ``Support continuation of 
treatment for SUD from preconception through pregnancy and one year 
postpartum and tailor

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medication assisted treatment according to parental need.''
    Commenters reaffirmed the need for research into pain management 
during pregnancy for women either with or without OUD. One asked that 
research into pain management during labor and delivery and postpartum 
for women with OUD be conducted. A recommendation in the research 
section of the treatment strategy (Table 12 of the final strategy) was 
revised to reflect these comments. It now reads: ``Research effective 
non-pharmacologic and non-opioid pharmacotherapies for pain management 
during pregnancy, labor and delivery, post-partum care and 
breastfeeding for women with chronic pain or opioid use disorder.''
    Another commenter recommended the scope of the recommendation 
``Determine the safety and effectiveness of naltrexone use during 
pregnancy and breastfeeding'' be expanded to include naloxone in both 
the strategies for prevention and treatment. Language was added to this 
recommendation in the treatment strategy (Table 12 of the final 
strategy) but not the prevention strategy. It was not included in the 
prevention section because naloxone does not have a role in preventing 
or reducing prenatal substance exposure. The recommendation now reads: 
``Determine the safety and effectiveness of naltrexone and naloxone 
when combined with buprenorphine use during pregnancy and 
breastfeeding.''
    Many commenters sought to reinforce specific elements of the 
strategy, refine broad research recommendations with more specific 
research questions, or inform how the recommendations might best be 
carried out. For example, a group of commenters emphasized ``the need 
for additional research into the impact on the fetus of drugs taken 
during pregnancy . . . especially when exposure is concurrent with 
opioids.'' There was a request for greater research on whether a 
subgroup of women at sufficiently low risk of relapse could be 
identified and detoxified safely and reliably and for more research on 
the impact of detoxification on the fetus. There was also a request for 
greater research on the most effective pharmacotherapy for infants with 
neonatal abstinence syndrome (NAS) and or NOWS. These comments 
reinforced or elaborated upon existing recommendations in the strategy 
and therefore the strategy was not edited to reflect them.

Services

    Several commenters raised concerns about criminal penalties 
experienced by pregnant and parenting women with substance use disorder 
and the uncertain benefit and unknown consequences of removing children 
from their parents due to prenatal substance exposure. This comment 
best summarizes the range of strategies suggested by the various 
comments:

    The current opioid epidemic is resulting in numerous referrals 
to and removals by the child welfare system. . . . But, since the 
primary purpose of the child welfare system is to investigate 
reports of abuse and neglect, child welfare workers often lack the 
appropriate training and resources to effectively address substance 
use disorders. . . . more research and resources are needed to help 
the child welfare system facilitate linkages to treatment and 
promote recovery for mothers with addiction.

    Another commenter pointed out that there is a ``non-evidence based 
assumption that removing children from women who use substances during 
pregnancy protects the child'' and several urged research into the 
risks and benefits of child removal due to prenatal substance exposure 
be added to the strategy. Two recommendations were added to the 
services strategy (Table 13 of the final strategy). First, ``Collect 
data on the welfare of substance exposed children who are removed from 
their families versus those remaining with a mother receiving 
supportive interventions'' was added to data collection. Second, 
``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'' was 
added to the education section.

General Comments

    A group of commenters noted that the strategy would be improved by 
greater synthesis of the recommendations and the definition of clear 
goals with associated metrics. There are several reasons why goals and 
metrics are not specified. First, the generally limited and 
inconsistent data collection described in the report currently 
precludes establishment of a national baseline upon which metrics can 
be established. Second, the establishment of goals and metrics is 
further complicated by the fact that for pregnant women with OUD, the 
most effective intervention to promote optimal outcomes for both mother 
and child is the provision of medication assisted treatment with an 
opioid agonist, which itself carries a risk of NOWS. As a result, 
reduction in the number of cases of NOWS is not a meaningful goal even 
if NOWS, as distinct from NAS, could be measured accurately. As a 
result, no changes were made to the strategy based on these comments.
    Supporting and Related Material in the Docket: The information 
provided includes:

(1) The Report
(2) The Final Strategy
(3) Public Comments

Summer King,
Statistician.
[FR Doc. 2017-10735 Filed 5-24-17; 8:45 am]
 BILLING CODE 4162-20-P