II 

Calendar No. 246 

114TH CONGRESS 

1ST SESSION S. 799 

To combat the rise of prenatal opioid abuse and neonatal abstinence 

syndrome. 

IN THE SENATE OF THE UNITED STATES 

MARCH 19, 2015 

Mr. MCCONNELL (for himself and Mr. CASEY, Ms. AYOTTE, Mr. PORTMAN, 

Mr. ISAKSON, Ms. BALDWIN, Mr. WHITEHOUSE, Mr. CORKER, Mr. 

BROWN, Mr. COONS, Mrs. GILLIBRAND, Mrs. CAPITO, Mrs. FISCHER, 

Mr. VITTER, Mr. BOOZMAN, Mr. COTTON, Mr. DONNELLY, Mr. KING, 

Mr. CARPER, Ms. COLLINS, Mrs. MURRAY, and Mr. TOOMEY) introduced 

the following bill; which was read twice and referred to the Committee 

on Health, Education, Labor, and Pensions 

OCTOBER 1, 2015 

Reported by Mr. ALEXANDER, with an amendment and an amendment to the 

title 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To combat the rise of prenatal opioid abuse and neonatal 

abstinence syndrome. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Protecting Our Infants 

3 Act of 2015’’. 

4 SEC. 2. FINDINGS. 

5 Congress finds as follows: 

6 (1) Opioid prescription rates have risen dra7 matically over the past several years. According to 

8 the Centers for Disease Control and Prevention, in 

9 some States, there are as many as 96 to 143 pre10 scriptions for opioids per 100 adults per year. 

11 (2) In recent years, there has been a steady rise 

12 in the number of overdose deaths involving heroin. 

13 According to the Centers for Disease Control and 

14 Prevention, the death rate for heroin overdose dou15 bled from 2010 to 2012. 

16 (3) At the same time, there has been an in17 crease in cases of neonatal abstinence syndrome (re18 ferred to in this section as ‘‘NAS’’). In the United 

19 States, the incidence of NAS has risen from 1.20 

20 per 1,000 hospital births in 2000 to 3.39 per 1,000 

21 hospital births in 2009. 

22 (4) NAS refers to medical issues associated 

23 with drug withdrawal in newborns due to exposure 

24 to opioids or other drugs in utero. 

25 (5) The average cost of treatment in a hospital 

26 for NAS increased from $39,400 in 2000 to $53,400 


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1 in 2009. Most of these costs are born by the Med2 icaid program. 

3 (6) Preventing opioid abuse among pregnant 

4 women and women of childbearing age is crucial. 

5 (7) Medically-appropriate opioid use in preg6 nancy is not uncommon, and opioids are often the 

7 safest and most appropriate treatment for moderate 

8 to severe pain for pregnant women. 

9 (8) Addressing NAS effectively requires a focus 

10 on women of childbearing age, pregnant women, and 

11 infants from preconception through early childhood. 

12 (9) NAS can result from the use of prescription 

13 drugs as prescribed for medical reasons, from the 

14 abuse of prescription drugs, or from the use of ille15 gal opioids like heroin. 

16 (10) For pregnant women who are abusing 

17 opioids, it is most appropriate to treat and manage 

18 maternal substance use in a non-punitive manner. 

19 (11) According to a report of the Government 

20 Accountability Office (referred to in this section as 

21 the ‘‘GAO report’’), more research is needed to opti22 mize the identification and treatment of babies with 

23 NAS and to better understand long-term impacts on 

24 children. 


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1 (12) According to the GAO report, the Depart2 ment of Health and Human Services does not have 

3 a focal point to lead planning and coordinating ef4 forts to address prenatal opioid use and NAS across 

5 the department. 

6 (13) According to the GAO report, ‘‘given the 

7 increasing use of heroin and abuse of opioids pre8 scribed for pain management, as well as the in9 creased rate of NAS in the United States, it is im10 portant to improve the efficiency and effectiveness of 

11 planning and coordination of Federal efforts on pre12 natal opioid use and NAS’’. 

13 SEC. 3. DEVELOPING RECOMMENDATIONS FOR PRE14 VENTING AND TREATING PRENATAL OPIOID 

15 ABUSE AND NEONATAL ABSTINENCE SYN16 DROME. 

17 (a) IN GENERAL.—The Secretary of Health and 

18 Human Services (referred to in this Act as the ‘‘Sec19 retary’’), acting through the Director of the Agency for 

20 Healthcare Research and Quality (referred to in this sec21 tion as the ‘‘Director’’), shall conduct a study and develop 

22 recommendations for preventing and treating prenatal 

23 opioid abuse and neonatal abstinence syndrome, soliciting 

24 input from nongovernmental entities, including organiza25 tions representing patients, health care providers, hosVerDate Sep 11 2014 00:07 Oct 02, 2015 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6401 E:\BILLS\S799.RS S799

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1 pitals, other treatment facilities, and other entities, as ap2 propriate. 

3 (b) REPORT.—Not later than 1 year after the date 

4 of enactment of this Act, the Director shall publish on the 

5 Internet Web site of the Agency for Healthcare Research 

6 and Quality a report on the study and recommendations 

7 under subsection (a). Such report shall address each of 

8 the issues described in paragraphs (1) through (3) of sub9 section (c). 

10 (c) CONTENTS.—The study described in subsection 

11 (a) and the report under subsection (b) shall include— 

12 (1) a comprehensive assessment of existing re13 search with respect to the prevention, identification, 

14 treatment, and long-term outcomes of neonatal ab15 stinence syndrome, including the identification and 

16 treatment of pregnant women or women who may 

17 become pregnant who use opioids or other drugs; 

18 (2) an evaluation of— 

19 (A) the causes of and risk factors for 

20 opioid use disorders among women of reproduc21 tive age, including pregnant women; 

22 (B) the barriers to identifying and treating 

23 opioid use disorders among women of reproduc24 tive age, including pregnant and postpartum 

25 women and women with young children; 


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1 (C) current practices in the health care 

2 system to respond to and treat pregnant women 

3 with opioid use disorders and infants born with 

4 neonatal abstinence syndrome; 

5 (D) medically indicated use of opioids dur6 ing pregnancy; 

7 (E) access to treatment for opioid use dis8 orders in pregnant and postpartum women; and 

9 (F) access to treatment for infants with 

10 neonatal abstinence syndrome; and 

11 (3) recommendations on— 

12 (A) preventing, identifying, and treating 

13 neonatal abstinence syndrome in infants; 

14 (B) treating pregnant women who are de15 pendent on opioids; and 

16 (C) preventing opioid dependence among 

17 women of reproductive age, including pregnant 

18 women, who may be at risk of developing opioid 

19 dependence. 

20 SEC. 4. IMPROVING PREVENTION AND TREATMENT FOR 

21 PRENATAL OPIOID ABUSE AND NEONATAL 

22 ABSTINENCE SYNDROME. 

23 (a) REVIEW OF PROGRAMS.—The Secretary shall 

24 lead a review of planning and coordination within the DeVerDate Sep 11 2014 00:07 Oct 02, 2015 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6401 E:\BILLS\S799.RS S799

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1 partment of Health and Human Services related to pre2 natal opioid use and neonatal abstinence syndrome. 

3 (b) STRATEGY TO CLOSE GAPS IN RESEARCH AND

4 PROGRAMMING.—In carrying out subsection (a), the Sec5 retary shall develop a strategy to address research and 

6 program gaps, including such gaps identified in findings 

7 made by reports of the Government Accountability Office. 

8 Such strategy shall address— 

9 (1) gaps in research, including with respect 

10 to— 

11 (A) the most appropriate treatment of 

12 pregnant women with opioid use disorders; 

13 (B) the most appropriate treatment and 

14 management of infants with neonatal absti15 nence syndrome; and 

16 (C) the long-term effects of prenatal opioid 

17 exposure on children; and 

18 (2) gaps in programs, including— 

19 (A) the availability of treatment programs 

20 for pregnant and postpartum women and for 

21 newborns with neonatal abstinence syndrome; 

22 and 

23 (B) guidance and coordination in Federal 

24 efforts to address prenatal opioid use or neo25 natal abstinence syndrome. 


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1 (c) REPORT.—Not later than 1 year after the date 

2 of enactment of this Act, the Secretary shall submit to 

3 the Committee on Health, Education, Labor, and Pen4 sions of the Senate and the Committee on Energy and 

5 Commerce of the House of Representatives a report on 

6 the findings of the review described in subsection (a) and 

7 the strategy developed under subsection (b). 

8 SEC. 5. IMPROVING DATA ON AND PUBLIC HEALTH RE9 SPONSE TO NEONATAL ABSTINENCE SYN10 DROME. 

11 (a) DATA AND SURVEILLANCE.—The Director of the 

12 Centers for Disease Control and Prevention shall, as ap13 propriate— 

14 (1) provide technical assistance to States to im15 prove the availability and quality of data collection 

16 and surveillance activities regarding neonatal absti17 nence syndrome, including— 

18 (A) the incidence and prevalence of neo19 natal abstinence syndrome; 

20 (B) the identification of causes for neo21 natal abstinence syndrome, including new and 

22 emerging trends; and 

23 (C) the demographics and other relevant 

24 information associated with neonatal abstinence 

25 syndrome; 


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1 (2) collect available surveillance data described 

2 in paragraph (1) from States, as applicable; and 

3 (3) make surveillance data collected pursuant to 

4 paragraph (2) publically available on an appropriate 

5 Internet Web site. 

6 (b) PUBLIC HEALTH RESPONSE.—The Director of 

7 the Centers for Disease Control and Prevention shall en8 courage increased utilization of effective public health 

9 measures to reduce neonatal abstinence syndrome. 

10 SECTION 1. SHORT TITLE. 

11 This Act may be cited as the ‘‘Protecting Our Infants 

12 Act of 2015’’. 

13 SEC. 2. ADDRESSING PROBLEMS RELATED TO PRENATAL 

14 OPIOID USE. 

15 (a) REVIEW OF PROGRAMS.—The Secretary of Health 

16 and Human Services (referred to in this Act as the ‘‘Sec17 retary’’) shall conduct a review of planning and coordina18 tion related to prenatal opioid use, including neonatal ab19 stinence syndrome, within the agencies of the Department 

20 of Health and Human Services. 

21 (b) STRATEGY.—In carrying out subsection (a), the 

22 Secretary shall develop a strategy to address gaps in re23 search and gaps, overlap, and duplication among Federal 

24 programs, including those identified in findings made by 


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1 reports of the Government Accountability Office. Such strat2 egy shall address— 

3 (1) gaps in research, including with respect to— 

4 (A) the most appropriate treatment of preg5 nant women with opioid use disorders; 

6 (B) the most appropriate treatment and 

7 management of infants with neonatal abstinence 

8 syndrome; and 

9 (C) the long-term effects of prenatal opioid 

10 exposure on children; 

11 (2) gaps, overlap, or duplication in— 

12 (A) substance use disorder treatment pro13 grams for pregnant and postpartum women; and 

14 (B) treatment program options for 

15 newborns with neonatal abstinence syndrome; 

16 (3) gaps, overlap, or duplication in Federal ef17 forts related to education about, and prevention of, 

18 neonatal abstinence syndrome; and 

19 (4) coordination of Federal efforts to address 

20 neonatal abstinence syndrome. 

21 (c) REPORT.—Not later than 1 year after the date of 

22 enactment of this Act, the Secretary shall submit to the 

23 Committee on Health, Education, Labor, and Pensions of 

24 the Senate and the Committee on Energy and Commerce 

25 of the House of Representatives a report concerning the 


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1 findings of the review conducted under subsection (a) and 

2 the strategy developed under subsection (b). 

3 SEC. 3. DEVELOPING RECOMMENDATIONS FOR PRE4 VENTING AND TREATING PRENATAL OPIOID 

5 USE DISORDERS. 

6 (a) IN GENERAL.—The Secretary shall conduct a 

7 study and develop recommendations for preventing and 

8 treating prenatal opioid use disorders, including the effects 

9 of such disorders on infants. In carrying out this subsection 

10 the Secretary shall— 

11 (1) take into consideration— 

12 (A) the review and strategy conducted and 

13 developed under section 2; and 

14 (B) the lessons learned from previous opioid 

15 epidemics; and 

16 (2) solicit input from States, localities, and Fed17 erally recognized Indian tribes or tribal organizations 

18 (as defined in the Indian Self-Determination and 

19 Education Assistance Act (25 U.S.C. 450b)), and 

20 nongovernmental entities, including organizations 

21 representing patients, health care providers, hospitals, 

22 other treatment facilities, and other entities, as ap23 propriate. 

24 (b) REPORT.—Not later than 18 months after the date 

25 of enactment of this Act, the Secretary shall make available 


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1 on the appropriate Internet Website of the Department of 

2 Health and Human Services a report on the recommenda3 tions under subsection (a). Such report shall address each 

4 of the issues described in subsection (c). 

5 (c) CONTENTS.—The recommendations described in 

6 subsection (a) and the report under subsection (b) shall in7 clude— 

8 (1) a comprehensive assessment of existing re9 search with respect to the prevention, identification, 

10 treatment, and long-term outcomes of neonatal absti11 nence syndrome, including the identification and 

12 treatment of pregnant women or women who may be13 come pregnant who use opioids or have opioid use 

14 disorders; 

15 (2) an evaluation of— 

16 (A) the causes of, and risk factors for, 

17 opioid use disorders among women of reproduc18 tive age, including pregnant women; 

19 (B) the barriers to identifying and treating 

20 opioid use disorders among women of reproduc21 tive age, including pregnant and postpartum 

22 women and women with young children; 

23 (C) current practices in the health care sys24 tem to respond to, and treat, pregnant women 


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1 with opioid use disorders and infants affected by 

2 such disorders; 

3 (D) medically indicated uses of opioids dur4 ing pregnancy; 

5 (E) access to treatment for opioid use dis6 orders in pregnant and postpartum women; and 

7 (F) access to treatment for infants with neo8 natal abstinence syndrome; and 

9 (G) differences in prenatal opioid use and 

10 use disorders in pregnant women between demo11 graphic groups; and 

12 (3) recommendations on— 

13 (A) preventing, identifying, and treating 

14 the effects of prenatal opioid use on infants; 

15 (B) treating pregnant women who have 

16 opioid use disorders; 

17 (C) preventing opioid use disorders among 

18 women of reproductive age, including pregnant 

19 women, who may be at risk of developing opioid 

20 use disorders; and 

21 (D) reducing disparities in opioid use dis22 orders among pregnant women. 


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1 SEC. 4. IMPROVING DATA AND THE PUBLIC HEALTH RE2 SPONSE. 

3 The Secretary may continue activities, as appropriate, 

4 related to— 

5 (1) providing technical assistance to support 

6 States and Federally recognized Indian Tribes in col7 lecting information on neonatal abstinence syndrome 

8 through the utilization of existing surveillance sys9 tems and collaborating with States and Federally rec10 ognized Indian Tribes to improve the quality, consist11 ency, and collection of such data; and 

12 (2) providing technical assistance to support 

13 States in implementing effective public health meas14 ures, such as disseminating information to educate 

15 the public, health care providers, and other stake16 holders on prenatal opioid use and neonatal absti17 nence syndrome. 

Amend the title so as to read: ‘‘To address problems 

related to prenatal opioid use.’’. 


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Calendar No. 246 

114TH CONGRESS 

1ST SESSION S. 799 

A BILL 

To combat the rise of prenatal opioid abuse and 

neonatal abstinence syndrome. 

OCTOBER 1, 2015 

Reported with an amendment and an amendment to the 

title 


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