82 FR 24137 - Protecting Our Infants Act Report to Congress: Summary of Public Comment and Final Strategy
DEPARTMENT OF HEALTH AND HUMAN SERVICE
Substance Abuse and Mental Health Services Administration Federal Register Volume 82, Issue 100 (May 25, 2017)
Substance Abuse and Mental Health Services Administration
Federal Register Volume 82, Issue 100 (May 25, 2017)
| Page Range | 24137-24138 | |
| FR Document | 2017-10735 |
[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)] [Notices] [Pages 24137-24138] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10735] [[Page 24137]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 [[Page 24138]] 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
![24138 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices
medication assisted treatment according substance use disorder and the changes were made to the strategy based
to parental need.’’ uncertain benefit and unknown on these comments.
Commenters reaffirmed the need for consequences of removing children Supporting and Related Material in
research into pain management during from their parents due to prenatal the Docket: The information provided
pregnancy for women either with or substance exposure. This comment best includes:
without OUD. One asked that research summarizes the range of strategies (1) The Report
into pain management during labor and suggested by the various comments: (2) The Final Strategy
delivery and postpartum for women (3) Public Comments
The current opioid epidemic is resulting in
with OUD be conducted. A numerous referrals to and removals by the Summer King,
recommendation in the research section child welfare system. . . . But, since the
of the treatment strategy (Table 12 of the Statistician.
primary purpose of the child welfare system
final strategy) was revised to reflect [FR Doc. 2017–10735 Filed 5–24–17; 8:45 am]
is to investigate reports of abuse and neglect,
these comments. It now reads: child welfare workers often lack the BILLING CODE 4162–20–P
‘‘Research effective non-pharmacologic appropriate training and resources to
and non-opioid pharmacotherapies for effectively address substance use disorders.
pain management during pregnancy, . . . more research and resources are needed DEPARTMENT OF HEALTH AND
labor and delivery, post-partum care to help the child welfare system facilitate HUMAN SERVICES
linkages to treatment and promote recovery
and breastfeeding for women with
for mothers with addiction. Substance Abuse and Mental Health
chronic pain or opioid use disorder.’’
Another commenter recommended Services Administration
Another commenter pointed out that
the scope of the recommendation there is a ‘‘non-evidence based Agency Information Collection
‘‘Determine the safety and effectiveness assumption that removing children from Activities: Submission for OMB
of naltrexone use during pregnancy and women who use substances during Review; Comment Request
breastfeeding’’ be expanded to include pregnancy protects the child’’ and
naloxone in both the strategies for several urged research into the risks and Periodically, the Substance Abuse and
prevention and treatment. Language was benefits of child removal due to prenatal Mental Health Services Administration
added to this recommendation in the substance exposure be added to the (SAMHSA) will publish a summary of
treatment strategy (Table 12 of the final strategy. Two recommendations were information collection requests under
strategy) but not the prevention strategy. added to the services strategy (Table 13 OMB review, in compliance with the
It was not included in the prevention of the final strategy). First, ‘‘Collect data Paperwork Reduction Act (44 U.S.C.
section because naloxone does not have on the welfare of substance exposed Chapter 35). To request a copy of these
a role in preventing or reducing prenatal children who are removed from their documents, call the SAMHSA Reports
substance exposure. The families versus those remaining with a Clearance Officer on (240) 276–1243.
recommendation now reads: ‘‘Determine mother receiving supportive Project: Participant Feedback on
the safety and effectiveness of
interventions’’ was added to data Training Under the Cooperative
naltrexone and naloxone when
collection. Second, ‘‘Promote training Agreement for Mental Health Care
combined with buprenorphine use
and resources for child welfare workers Provider Education in HIV/AIDS
during pregnancy and breastfeeding.’’
Many commenters sought to reinforce to effectively address SUD and prenatal Program (OMB No. 0930–0195)—
specific elements of the strategy, refine substance exposure, facilitate linkages Extension
broad research recommendations with to treatment, and promote recovery for The Substance Abuse and Mental
more specific research questions, or mothers with SUD’’ was added to the Health Services Administration’s
inform how the recommendations might education section. (SAMHSA) Center for Mental Health
best be carried out. For example, a General Comments Services (CMHS) intends to continue to
group of commenters emphasized ‘‘the conduct a multi-site assessment for the
need for additional research into the A group of commenters noted that the Mental Health Care Provider Education
impact on the fetus of drugs taken strategy would be improved by greater in HIV/AIDS Program. There are no
during pregnancy . . . especially when synthesis of the recommendations and changes to the forms or the burden
exposure is concurrent with opioids.’’ the definition of clear goals with hours.
There was a request for greater research associated metrics. There are several The education programs are funded
on whether a subgroup of women at reasons why goals and metrics are not under a cooperative agreement that are
sufficiently low risk of relapse could be specified. First, the generally limited designed to disseminate knowledge of
identified and detoxified safely and and inconsistent data collection the psychological and neuropsychiatric
reliably and for more research on the described in the report currently sequelae of HIV/AIDS to both traditional
impact of detoxification on the fetus. precludes establishment of a national (e.g., psychiatrists, psychologists,
There was also a request for greater baseline upon which metrics can be nurses, primary care physicians,
research on the most effective established. Second, the establishment medical students, and social workers)
pharmacotherapy for infants with of goals and metrics is further and non-traditional (e.g., clergy, and
neonatal abstinence syndrome (NAS) complicated by the fact that for pregnant alternative health care workers) first-
and or NOWS. These comments women with OUD, the most effective line providers of mental health services,
reinforced or elaborated upon existing intervention to promote optimal in particular to providers in minority
recommendations in the strategy and outcomes for both mother and child is communities.
therefore the strategy was not edited to the provision of medication assisted The multi-site assessment is designed
reflect them. treatment with an opioid agonist, which to assess the effectiveness of particular
itself carries a risk of NOWS. As a training curricula, document the
Services result, reduction in the number of cases integrity of training delivery formats,
Several commenters raised concerns of NOWS is not a meaningful goal even and assess the effectiveness of the
about criminal penalties experienced by if NOWS, as distinct from NAS, could various training delivery formats.
pregnant and parenting women with be measured accurately. As a result, no Analyses will assist CMHS in
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Document Created: 2018-11-08 08:52:58
Document Modified: 2018-11-08 08:52:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 | |
| FR Citation | 82 FR 24137 |
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