I 

114TH CONGRESS 

2D SESSION H. R. 4841 

To establish programs for health care provider training in Federal health 

care and medical facilities, to establish Federal co-prescribing guidelines, 

to establish a grant program with respect to naloxone, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 23, 2016 

Mr. ROTHFUS (for himself and Mr. KEATING) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committees on Armed Services, Veterans’ Affairs, and 

Natural Resources, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

A BILL 

To establish programs for health care provider training in 

Federal health care and medical facilities, to establish 

Federal co-prescribing guidelines, to establish a grant 

program with respect to naloxone, and for other purposes. 

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 Saves 

5 Lives Act of 2016’’. 


smartinez on DSK9F6TC42PROD with BILLS
2 

•HR 4841 IH

1 SEC. 2. FINDINGS. 

2 Congress finds as follows: 

3 (1) Together, the misuse of heroin and opioids 

4 account for approximately 25,000 deaths in the 

5 United States per year. 

6 (2) Drug overdose was the leading cause of in7 jury death in the United States in 2013, and among 

8 people 25 to 64 years old, drug overdose caused 

9 more deaths than motor vehicle fatalities in 2013. 

10 (3) According to the Centers for Disease Con11 trol and Prevention, in the United States, fatal 

12 opioid-related drug overdose rates have more than 

13 quadrupled since 1990 and have never been higher. 

14 Each day in the United States, 46 people die from 

15 an overdose of prescription painkillers. Nearly 

16 2,000,000 Americans aged 12 or older either abused 

17 or were dependent on opioids in 2013. 

18 (4) Naloxone is a safe and effective antidote to 

19 all opioid-related overdoses, including heroin and 

20 fentanyl, and is a critical tool in preventing fatal 

21 opioid overdoses in both health care and at-home 

22 settings. 

23 (5) The opioid overdose antidote naloxone has 

24 reversed more than 26,000 overdose cases between 

25 1996 and 2014, according to the Centers for Dis26 ease Control and Prevention. 


smartinez on DSK9F6TC42PROD with BILLS
3 

•HR 4841 IH

1 SEC. 3. HEALTH CARE PROVIDER TRAINING IN FEDERAL 

2 HEALTH CARE AND MEDICAL FACILITIES. 

3 (a) GUIDELINES.— 

4 (1) HHS GUIDELINES.—The Secretary of 

5 Health and Human Services shall establish health 

6 care provider training guidelines for all Federal 

7 health care facilities, including Federally qualified 

8 health centers (as defined in paragraph (4) of sec9 tion 1861(aa) of the Social Security Act (42 U.S.C. 

10 1395x(aa))) and facilities of the Indian Health Serv11 ice, and shall provide training to all providers de12 scribed in subsection (b), in accordance with sub13 section (c). 

14 (2) DEPARTMENT OF VETERANS AFFAIRS

15 GUIDELINES.—The Secretary of Veterans Affairs 

16 shall establish health care provider training guide17 lines for all medical facilities of the Department of 

18 Veterans Affairs, and shall provide training to all 

19 providers described in subsection (b), in accordance 

20 with subsection (c). 

21 (3) DEPARTMENT OF DEFENSE GUIDELINES.— 

22 The Secretary of Defense shall establish health care 

23 provider training guidelines for all medical facilities 

24 of the Department of Defense, and shall provide 

25 training to all providers described in subsection (b), 

26 in accordance with subsection (c). 


smartinez on DSK9F6TC42PROD with BILLS
4 

•HR 4841 IH

1 (b) AFFECTED HEALTH CARE PROVIDERS.—The 

2 guidelines developed under paragraphs (1) through (3) of 

3 subsection (a) shall ensure that training on the appro4 priate and effective prescribing of opioid medications is 

5 provided to all health care providers who are— 

6 (1) Federal employees and who prescribe con7 trolled substances as part of their official respon8 sibilities and duties as Federal employees; 

9 (2) contractors in a health care or medical facil10 ity of an agency described in paragraph (1), (2), or 

11 (3) of subsection (a) who— 

12 (A) spend 50 percent or more of their clin13 ical time under contract with the Federal Gov14 ernment; and 

15 (B) prescribe controlled substances under 

16 the terms and conditions of their contract or 

17 agreement with the Federal Government; or 

18 (3) clinical residents and other clinical trainees 

19 who spend 50 percent or more of their clinical time 

20 practicing in a health care or medical facility of an 

21 agency described in paragraph (1), (2), or (3) of 

22 subsection (a). 

23 (c) TRAINING REQUIREMENTS.— 

24 (1) TRAINING TOPICS.—The training developed 

25 under paragraphs (1) through (3) of subsection (a) 


smartinez on DSK9F6TC42PROD with BILLS
5 

•HR 4841 IH

1 shall address, at a minimum, best practices for ap2 propriate and effective prescribing of pain medica3 tions, principles of pain management, the misuse po4 tential of controlled substances, identification of po5 tential substance use disorders and referral to fur6 ther evaluation and treatment, and proper methods 

7 for disposing of controlled substances. 

8 (2) TRAINING APPROACHES.—The training ap9 proaches developed in accordance with this section 

10 may include both traditional continuing education 

11 models and models that pair intensive coaching for 

12 the highest volume prescribers with case-based 

13 courses for other prescribers. 

14 (3) CONSISTENCY WITH CONSENSUS GUIDE15 LINES.—To the extent practicable, training adopted 

16 under subsection (a) shall be consistent with con17 sensus guidelines on pain medication prescribing de18 veloped by the Centers for Disease Control and Pre19 vention. 

20 (4) TRAINING FREQUENCY.—Each agency de21 scribed in paragraphs (1) through (3) of subsection 

22 (a) shall provide training of the health care pro23 viders in accordance with this section not later than 

24 18 months after the date of enactment of this Act, 

25 and every 3 years thereafter. 


smartinez on DSK9F6TC42PROD with BILLS
6 

•HR 4841 IH

1 (d) DEFINITIONS.—For purposes of this section, the 

2 term ‘‘controlled substance’’ has the meaning given such 

3 term in section 102 of the Controlled Substances Act (21 

4 U.S.C. 802). 

5 SEC. 4. NALOXONE CO-PRESCRIBING IN FEDERAL HEALTH 

6 CARE AND MEDICAL FACILITIES. 

7 (a) NALOXONE CO-PRESCRIBING GUIDELINES.—Not 

8 later than 180 days after the date of enactment of this 

9 Act: 

10 (1) The Secretary of Health and Human Serv11 ices shall establish naloxone co-prescribing guidelines 

12 applicable to all Federally qualified health centers 

13 (as defined in paragraph (4) of section 1861(aa) of 

14 the Social Security Act (42 U.S.C. 1395x(aa))) and 

15 the health care facilities of the Indian Health Serv16 ice. 

17 (2) The Secretary of Defense shall establish co18 prescribing guidelines applicable to all Department 

19 of Defense medical facilities. 

20 (3) The Secretary of Veterans Affairs shall es21 tablish co-prescribing guidelines applicable to all De22 partment of Veterans Affairs medical facilities. 

23 (b) REQUIREMENT.—The guidelines established 

24 under subsection (a) shall address naloxone co-prescribing 


smartinez on DSK9F6TC42PROD with BILLS
7 

•HR 4841 IH

1 for both pain patients receiving chronic opioid therapy and 

2 patients being treated for opioid use disorders. 

3 (c) DEFINITIONS.—In this section: 

4 (1) CO-PRESCRIBING.—The term ‘‘co-pre5 scribing’’ means, with respect to an opioid overdose 

6 reversal drug, the practice of prescribing such drug 

7 in conjunction with an opioid prescription for pa8 tients at an elevated risk of overdose, or in conjunc9 tion with an opioid agonist approved under section 

10 505 of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 355) for the treatment of opioid use dis12 orders, or in other circumstances in which a provider 

13 identifies a patient at an elevated risk for an inten14 tional or unintentional drug overdose from heroin or 

15 prescription opioid therapies. 

16 (2) ELEVATED RISK OF OVERDOSE.—The term 

17 ‘‘elevated risk of overdose’’ has the meaning given 

18 such term by the Secretary of Health and Human 

19 Services, which— 

20 (A) may be based on the criteria provided 

21 in the Opioid Overdose Toolkit published by the 

22 Substance Abuse and Mental Health Services 

23 Administration; and 

24 (B) may include patients on a first course 

25 opioid treatment, patients using extended-reVerDate Sep 11 2014 03:52 Mar 24, 2016 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4841.IH H4841

smartinez on DSK9F6TC42PROD with BILLS
8 

•HR 4841 IH

1 lease and long-acting opioid analgesic, and pa2 tients with a respiratory disease or other co3 morbidities. 

4 SEC. 5. GRANT PROGRAM TO STATE DEPARTMENTS OF 

5 HEALTH TO EXPAND NALOXONE CO-PRE6 SCRIBING. 

7 (a) ESTABLISHMENT.—Not later than 180 days after 

8 the date of the enactment of this Act, the Secretary of 

9 Health and Human Services (referred to in this section 

10 as the ‘‘Secretary’’) shall establish a competitive 4-year 

11 co-prescribing opioid overdose reversal drugs grant pro12 gram to provide State departments of health with re13 sources to develop and apply co-prescribing guidelines, and 

14 to provide for increased access to naloxone. 

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

16 under this section, a State shall submit to the Secretary, 

17 in such form and manner as the Secretary may require, 

18 an application that— 

19 (1) identifies community partners for a co-pre20 scribing program; 

21 (2) identifies which providers will be trained in 

22 such program and the criteria that will be used to 

23 identify eligible patients to participate in such pro24 gram; and 


smartinez on DSK9F6TC42PROD with BILLS
9 

•HR 4841 IH

1 (3) describes how the program will seek to iden2 tify State, local, or private funding to continue the 

3 program after expiration of the grant. 

4 (c) PRIORITIZATION.—In awarding grants under this 

5 section, the Secretary shall give priority to eligible State 

6 departments of health that propose to base State guide7 lines on guidelines on co-prescribing already in existence 

8 at the time of application, such as guidelines of the De9 partment of Veterans Affairs or national medical societies, 

10 such as the American Society of Addiction Medicine or 

11 American Medical Association. 

12 (d) USE OF FUNDS.—A State department of health 

13 receiving a grant under this section may use the grant 

14 for any of the following activities: 

15 (1) To establish a program for co-prescribing 

16 opioid overdose reversal drugs, such as naloxone. 

17 (2) To expand innovative models of naloxone 

18 distribution, as defined by the Secretary. 

19 (3) To train and provide resources for health 

20 care providers and pharmacists on the co-prescribing 

21 of opioid overdose reversal drugs. 

22 (4) To establish mechanisms and processes for 

23 tracking patients participating in the program de24 scribed in paragraph (1) and the health outcomes of 


smartinez on DSK9F6TC42PROD with BILLS
10 

•HR 4841 IH

1 such patients, and ensuring that health information 

2 is de-identified so as to protect patient privacy. 

3 (5) To purchase opioid overdose reversal drugs 

4 for distribution under the program described in 

5 paragraph (1). 

6 (6) To offset the copayments and other cost7 sharing associated with opioid overdose reversal 

8 drugs to ensure that cost is not a limiting factor for 

9 eligible individuals, as determined by the Secretary 

10 and the applicable State department of health, giv11 ing priority to individuals not otherwise insured for 

12 such services. 

13 (7) To conduct community outreach, in con14 junction with community-based organizations, de15 signed to raise awareness of co-prescribing practices, 

16 and the availability of opioid overdose reversal 

17 drugs. 

18 (8) To establish protocols to connect patients 

19 who have experienced a drug overdose with appro20 priate treatment, including appropriate counseling 

21 and behavioral therapies. Such protocols shall be 

22 consistent with nationally recognized patient place23 ment criteria, such as the criteria of the American 

24 Society of Addiction Medicine. 


smartinez on DSK9F6TC42PROD with BILLS
11 

•HR 4841 IH

1 (e) EVALUATIONS BY RECIPIENTS.—As a condition 

2 of receipt of a grant under this section, a State depart3 ment of health shall, for each year for which grant funds 

4 are received, submit to the Secretary information on ap5 propriate outcome measures specified by the Secretary to 

6 assess the outcomes of the program funded by the grant. 

7 (f) DEFINITION.—In this section, the term ‘‘co-pre8 scribing’’ has the meaning given such term in section 4. 

9 SEC. 6. AUTHORIZATION OF APPROPRIATIONS. 

10 There is authorized to be appropriated to carry out 

11 this Act $2,500,000 for each of fiscal years 2017 through 

12 2021. 

Æ 


smartinez on DSK9F6TC42PROD with BILLS