IIB 

114TH CONGRESS 

2D SESSION H. R. 3680 

IN THE SENATE OF THE UNITED STATES 

MAY 12, 2016 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

To provide for the Secretary of Health and Human Services 

to carry out a grant program for co-prescribing opioid 

overdose reversal drugs. 

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


emcdonald on DSK67QTVN1PROD with BILLS
2 

HR 3680 RFS 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Co-Prescribing to Re3 duce Overdoses Act of 2016’’. 

4 SEC. 2. OPIOID OVERDOSE REVERSAL DRUGS PRE5 SCRIBING GRANT PROGRAM. 

6 (a) ESTABLISHMENT.— 

7 (1) IN GENERAL.—Not later than 6 months 

8 after the date of the enactment of this Act, the Sec9 retary of Health and Human Services may establish, 

10 in accordance with this section, a 5-year opioid over11 dose reversal drugs prescribing grant program (in 

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

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

14 under this section may not be for more than 

15 $200,000 per grant year. 

16 (3) ELIGIBLE ENTITY.—For purposes of this 

17 section, the term ‘‘eligible entity’’ means a federally 

18 qualified health center (as defined in section 

19 1861(aa) of the Social Security Act (42 U.S.C. 

20 1395x(aa)), an opioid treatment program under part 

21 8 of title 42, Code of Federal Regulations, any prac22 titioner dispensing narcotic drugs pursuant to sec23 tion 303(g) of the Controlled Substances Act (21 

24 U.S.C. 823(g)), or any other entity that the Sec25 retary deems appropriate. 


emcdonald on DSK67QTVN1PROD with BILLS
3 

HR 3680 RFS 

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

2 and section 3, the term ‘‘prescribing’’ means, with 

3 respect to an opioid overdose reversal drug, such as 

4 naloxone, the practice of prescribing such drug— 

5 (A) in conjunction with an opioid prescrip6 tion for patients at an elevated risk of overdose; 

7 (B) in conjunction with an opioid agonist 

8 approved under section 505 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

10 for the treatment of opioid abuse disorder; 

11 (C) to the caregiver or a close relative of 

12 patients at an elevated risk of overdose from 

13 opioids; or 

14 (D) in other circumstances, as identified 

15 by the Secretary, in which a provider identifies 

16 a patient is at an elevated risk for an inten17 tional or unintentional drug overdose from her18 oin or prescription opioid therapies. 

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

20 under this section, an eligible entity shall submit to the 

21 Secretary of Health and Human Services, in such form 

22 and manner as specified by the Secretary, an application 

23 that describes— 

24 (1) the extent to which the area to which the 

25 entity will furnish services through use of the grant 


emcdonald on DSK67QTVN1PROD with BILLS
4 

HR 3680 RFS 

1 is experiencing significant morbidity and mortality 

2 caused by opioid abuse; 

3 (2) the criteria that will be used to identify eli4 gible patients to participate in such program; and 

5 (3) how such program will work to try to iden6 tify State, local, or private funding to continue the 

7 program after expiration of the grant. 

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

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

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

11 of the grant funds for activities described in paragraphs 

12 (4) and (5): 

13 (1) To establish a program for prescribing 

14 opioid overdose reversal drugs, such as naloxone. 

15 (2) To train and provide resources for health 

16 care providers and pharmacists on the prescribing of 

17 opioid overdose reversal drugs, such as naloxone. 

18 (3) To establish mechanisms and processes for 

19 tracking patients participating in the program de20 scribed in paragraph (1) and the health outcomes of 

21 such patients. 

22 (4) To purchase opioid overdose reversal drugs, 

23 such as naloxone, for distribution under the program 

24 described in paragraph (1). 


emcdonald on DSK67QTVN1PROD with BILLS
5 

HR 3680 RFS 

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

2 associated with opioid overdose reversal drugs, such 

3 as naloxone, to ensure that cost is not a limiting fac4 tor for eligible patients. 

5 (6) To conduct community outreach, in con6 junction with community-based organizations, de7 signed to raise awareness of prescribing practices, 

8 and the availability of opioid overdose reversal 

9 drugs, such as naloxone. 

10 (7) To establish protocols to connect patients 

11 who have experienced a drug overdose with appro12 priate treatment, including medication assisted 

13 treatment and appropriate counseling and behavioral 

14 therapies. 

15 (d) EVALUATIONS BY RECIPIENTS.—As a condition 

16 of receipt of a grant under this section, an eligible entity 

17 shall, for each year for which the grant is received, submit 

18 to the Secretary of Health and Human Services informa19 tion on appropriate outcome measures specified by the 

20 Secretary to assess the outcomes of the program funded 

21 by the grant, including— 

22 (1) the number of prescribers trained; 

23 (2) the number of prescribers who have co-pre24 scribed an opioid overdose reversal drug, such as 

25 naloxone, to at least one patient; 


emcdonald on DSK67QTVN1PROD with BILLS
6 

HR 3680 RFS 

1 (3) the total number of prescriptions written for 

2 opioid overdose reversal drugs, such as naloxone; 

3 (4) the percentage of patients at elevated risk 

4 who received a prescription for an opioid overdose 

5 reversal drug, such as naloxone; 

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

7 opioid overdose reversal drug, such as naloxone; and 

8 (6) any other outcome measures that the Sec9 retary deems appropriate. 

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

11 grant program under this section, the Secretary of Health 

12 and Human Services shall submit to the appropriate com13 mittees of the House of Representatives and of the Senate 

14 a report aggregating the information received from the 

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

16 evaluating the outcomes achieved by the programs funded 

17 by grants made under this section. 

18 SEC. 3. PROVIDING INFORMATION TO PRESCRIBERS IN 

19 CERTAIN FEDERAL HEALTH CARE AND MED20 ICAL FACILITIES ON BEST PRACTICES FOR 

21 PRESCRIBING OPIOID OVERDOSE REVERSAL 

22 DRUGS. 

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

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

25 Human Services (in this section referred to as the ‘‘SecVerDate Sep 11 2014 02:48 May 13, 2016 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3680.RFS H3680

emcdonald on DSK67QTVN1PROD with BILLS
7 

HR 3680 RFS 

1 retary’’) may, as appropriate, provide information to pre2 scribers within federally qualified health centers (as de3 fined in paragraph (4) of section 1861(aa) of the Social 

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

5 facilities of the Indian Health Service, on best practices 

6 for prescribing opioid overdose reversal drugs, such as 

7 naloxone, for patients receiving chronic opioid therapy, pa8 tients being treated for opioid use disorders, and other pa9 tients that a provider identifies as having an elevated risk 

10 of overdose from heroin or prescription opioid therapies. 

11 (b) NOT ESTABLISHING A MEDICAL STANDARD OF

12 CARE.—The information on best practices provided under 

13 this section shall not be construed as constituting or estab14 lishing a medical standard of care for prescribing opioid 

15 overdose reversal drugs, such as naloxone, for patients de16 scribed in subsection (a). 

17 (c) ELEVATED RISK OF OVERDOSE DEFINED.—In 

18 this section, the term ‘‘elevated risk of overdose’’ has the 

19 meaning given such term by the Secretary, which— 

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

21 Opioid Overdose Toolkit published by the Substance 

22 Abuse and Mental Health Services Administration 

23 (SAMHSA); and 

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

25 treatment, patients using extended-release and longVerDate Sep 11 2014 02:48 May 13, 2016 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3680.RFS H3680

emcdonald on DSK67QTVN1PROD with BILLS
8 

HR 3680 RFS 

1 acting opioid analgesics, and patients with a res2 piratory disease or other co-morbidities. 

3 SEC. 4. AUTHORIZATION OF APPROPRIATIONS. 

4 There is authorized to be appropriated to carry out 

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

6 through 2021. 

7 SEC. 5. CUT-GO COMPLIANCE. 

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

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

10 before the period at the end the following: ‘‘(except such 

11 dollar amount shall be reduced by $5,000,000 for fiscal 

12 year 2018)’’. 

Passed the House of Representatives May 11, 2016. 

Attest: KAREN L. HAAS, 

Clerk. 


emcdonald on DSK67QTVN1PROD with BILLS