IB 

Union Calendar No. 427 

114TH CONGRESS 

2D SESSION H. R. 3680 

[Report No. 114–553] 

To provide for the Secretary of Health and Human Services to carry out 

a grant program for co-prescribing opioid overdose reversal drugs. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 1, 2015 

Mr. SARBANES introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

MAY 10, 2016 

Additional sponsors: Mr. BUCSHON, Mr. HULTGREN, Mr. BILIRAKIS, Mr. 

SHUSTER, and Ms. MCSALLY

MAY 10, 2016 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

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

[For text of introduced bill, see copy of bill as introduced on October 1, 2015] 


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A BILL 

To provide for the Secretary of Health and Human Services 

to carry out a grant program for co-prescribing opioid 

overdose reversal drugs. 


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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Co-Prescribing to Re5 duce Overdoses Act of 2016’’. 

6 SEC. 2. OPIOID OVERDOSE REVERSAL DRUGS PRESCRIBING 

7 GRANT PROGRAM. 

8 (a) ESTABLISHMENT.— 

9 (1) IN GENERAL.—Not later than six months 

10 after the date of the enactment of this Act, the Sec11 retary of Health and Human Services may establish, 

12 in accordance with this section, a five-year opioid 

13 overdose reversal drugs prescribing grant program (in 

14 this Act referred to as the ‘‘grant program’’). 

15 (2) MAXIMUM GRANT AMOUNT.—A grant made 

16 under this section may not be for more than $200,000 

17 per grant year. 

18 (3) ELIGIBLE ENTITY.—For purposes of this sec19 tion, the term ‘‘eligible entity’’ means a federally 

20 qualified health center (as defined in section 1861(aa) 

21 of the Social Security Act (42 U.S.C. 1395x(aa)), an 

22 opioid treatment program under part 8 of title 42, 

23 Code of Federal Regulations, any practitioner dis24 pensing narcotic drugs pursuant to section 303(g) of 

25 the Controlled Substances Act (21 U.S.C. 823(g)), or 


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1 any other entity that the Secretary deems appro2 priate. 

3 (4) PRESCRIBING.—For purposes of this section 

4 and section 3, the term ‘‘prescribing’’ means, with re5 spect to an opioid overdose reversal drug, such as 

6 naloxone, the practice of prescribing such drug— 

7 (A) in conjunction with an opioid prescrip8 tion for patients at an elevated risk of overdose; 

9 (B) in conjunction with an opioid agonist 

10 approved under section 505 of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 355) for the 

12 treatment of opioid abuse disorder; 

13 (C) to the caregiver or a close relative of pa14 tients at an elevated risk of overdose from 

15 opioids; or 

16 (D) in other circumstances, as identified by 

17 the Secretary, in which a provider identifies a 

18 patient is at an elevated risk for an intentional 

19 or unintentional drug overdose from heroin or 

20 prescription opioid therapies. 

21 (b) APPLICATION.—To be eligible to receive a grant 

22 under this section, an eligible entity shall submit to the Sec23 retary of Health and Human Services, in such form and 

24 manner as specified by the Secretary, an application that 

25 describes— 


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1 (1) the extent to which the area to which the en2 tity will furnish services through use of the grant is 

3 experiencing significant morbidity and mortality 

4 caused by opioid abuse; 

5 (2) the criteria that will be used to identify eligi6 ble patients to participate in such program; and 

7 (3) how such program will work to try to iden8 tify State, local, or private funding to continue the 

9 program after expiration of the grant. 

10 (c) USE OF FUNDS.—An eligible entity receiving a 

11 grant under this section may use the grant for any of the 

12 following activities, but may use not more than 20 percent 

13 of the grant funds for activities described in paragraphs 

14 (4) and (5): 

15 (1) To establish a program for prescribing opioid 

16 overdose reversal drugs, such as naloxone. 

17 (2) To train and provide resources for health 

18 care providers and pharmacists on the prescribing of 

19 opioid overdose reversal drugs, such as naloxone. 

20 (3) To establish mechanisms and processes for 

21 tracking patients participating in the program de22 scribed in paragraph (1) and the health outcomes of 

23 such patients. 


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1 (4) To purchase opioid overdose reversal drugs, 

2 such as naloxone, for distribution under the program 

3 described in paragraph (1). 

4 (5) To offset the co-pays and other cost sharing 

5 associated with opioid overdose reversal drugs, such 

6 as naloxone, to ensure that cost is not a limiting fac7 tor for eligible patients. 

8 (6) To conduct community outreach, in conjunc9 tion with community-based organizations, designed to 

10 raise awareness of prescribing practices, and the 

11 availability of opioid overdose reversal drugs, such as 

12 naloxone. 

13 (7) To establish protocols to connect patients who 

14 have experienced a drug overdose with appropriate 

15 treatment, including medication assisted treatment 

16 and appropriate counseling and behavioral therapies. 

17 (d) EVALUATIONS BY RECIPIENTS.—As a condition of 

18 receipt of a grant under this section, an eligible entity shall, 

19 for each year for which the grant is received, submit to the 

20 Secretary of Health and Human Services information on 

21 appropriate outcome measures specified by the Secretary to 

22 assess the outcomes of the program funded by the grant, in23 cluding— 

24 (1) the number of prescribers trained; 


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1 (2) the number of prescribers who have co-pre2 scribed an opioid overdose reversal drug, such as 

3 naloxone, to at least one patient; 

4 (3) the total number of prescriptions written for 

5 opioid overdose reversal drugs, such as naloxone; 

6 (4) the percentage of patients at elevated risk 

7 who received a prescription for an opioid overdose re8 versal drug, such as naloxone; 

9 (5) the number of patients reporting use of an 

10 opioid overdose reversal drug, such as naloxone; and 

11 (6) any other outcome measures that the Sec12 retary deems appropriate. 

13 (e) REPORTS BY SECRETARY.—For each year of the 

14 grant program under this section, the Secretary of Health 

15 and Human Services shall submit to the appropriate com16 mittees of the House of Representatives and of the Senate 

17 a report aggregating the information received from the 

18 grant recipients for such year under subsection (d) and 

19 evaluating the outcomes achieved by the programs funded 

20 by grants made under this section. 


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1 SEC. 3. PROVIDING INFORMATION TO PRESCRIBERS IN 

2 CERTAIN FEDERAL HEALTH CARE AND MED3 ICAL FACILITIES ON BEST PRACTICES FOR 

4 PRESCRIBING OPIOID OVERDOSE REVERSAL 

5 DRUGS. 

6 (a) IN GENERAL.—Not later than 180 days after the 

7 date of enactment of this Act, the Secretary of Health and 

8 Human Services (in this section referred to as the ‘‘Sec9 retary’’) may, as appropriate, provide information to pre10 scribers within Federally qualified health centers (as de11 fined in paragraph (4) of section 1861(aa) of the Social 

12 Security Act (42 U.S.C. 1395x(aa))), and the health care 

13 facilities of the Indian Health Service, on best practices for 

14 prescribing opioid overdose reversal drugs, such as 

15 naloxone, for patients receiving chronic opioid therapy, pa16 tients being treated for opioid use disorders, and other pa17 tients that a provider identifies as having an elevated risk 

18 of overdose from heroin or prescription opioid therapies. 

19 (b) NOT ESTABLISHING A MEDICAL STANDARD OF

20 CARE.—The information on best practices provided under 

21 this section shall not be construed as constituting or estab22 lishing a medical standard of care for prescribing opioid 

23 overdose reversal drugs, such as naloxone, for patients de24 scribed in subsection (a). 

25 (c) NO AUTHORIZATION OF ANY ADDITIONAL APPRO26 PRIATIONS.—The Secretary shall carry out this section 


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1 through funds otherwise appropriated and nothing in this 

2 section shall be construed as authorizing the appropriations 

3 of additional funds to carry out this section. 

4 (d) ELEVATED RISK OF OVERDOSE DEFINED.—In this 

5 section, the term ‘‘elevated risk of overdose’’ has the meaning 

6 given such term by the Secretary, which— 

7 (1) may be based on the criteria provided in the 

8 Opioid Overdose Toolkit published by the Substance 

9 Abuse and Mental Health Services Administration 

10 (SAMHSA); and 

11 (2) may include patients on a first course opioid 

12 treatment, patients using extended-release and long13 acting opioid analgesics, and patients with a res14 piratory disease or other co-morbidities. 

15 SEC. 4. AUTHORIZATION OF APPROPRIATIONS. 

16 There is authorized to be appropriated to carry out 

17 this Act $5,000,000 for the period of fiscal years 2017 

18 through 2021. 

19 SEC. 5. CUT-GO COMPLIANCE. 

20 Subsection (f) of section 319D of the Public Health 

21 Service Act (42 U.S.C. 247d–4) is amended by inserting 

22 before the period at the end the following: ‘‘(except such dol23 lar amount shall be reduced by $5,000,000 for fiscal year 

24 2018)’’. 


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Union Calendar No. 427 

114TH CONGRESS 

2D SESSION H. R. 3680 

[Report No. 114–553] 

A BILL 

To provide for the Secretary of Health and Human 

scribing opioid overdose reversal drugs. Services to carry out a grant program for co-preMAY 10, 2016 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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