IB 

Union Calendar No. 429 

114TH CONGRESS 

2D SESSION H. R. 4586 

[Report No. 114–555] 

To amend the Public Health Service Act to authorize grants to States for 

developing standing orders and educating health care professionals regarding the dispensing of opioid overdose reversal medication without 

person-specific prescriptions, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 23, 2016 

Mr. DOLD (for himself and Ms. CLARK of Massachusetts) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

MAY 10, 2016 

Additional sponsors: Mrs. COMSTOCK, Mr. MCGOVERN, Mr. ROKITA, Mr. 

PAULSEN, Mr. TURNER, 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 February 23, 2016] 


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A BILL 

To amend the Public Health Service Act to authorize grants 

to States for developing standing orders and educating 

health care professionals regarding the dispensing of 

opioid overdose reversal medication without person-specific prescriptions, and for other purposes. 


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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 ‘‘Lali’s Law’’. 

5 SEC. 2. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS 

6 AND EDUCATION GRANT PROGRAMS. 

7 (a) TECHNICAL CLARIFICATION.—Effective as if in8 cluded in the enactment of the Children’s Health Act of 

9 2000 (Public Law 106–310), section 3405(a) of such Act 

10 (114 Stat. 1221) is amended by striking ‘‘Part E of title 

11 III’’ and inserting ‘‘Part E of title III of the Public Health 

12 Service Act’’. 

13 (b) AMENDMENT.—Title III of the Public Health Serv14 ice Act is amended by inserting after part D of such title 

15 (42 U.S.C. 254b et seq.) the following new part E: 

16 ‘‘PART E—OPIOID USE DISORDER 

17 ‘‘SEC. 341. OPIOID OVERDOSE REVERSAL MEDICATION AC18 CESS AND EDUCATION GRANT PROGRAMS. 

19 ‘‘(a) GRANTS TO STATES.—The Secretary may make 

20 grants to States for— 

21 ‘‘(1) developing standing orders for pharmacies 

22 regarding opioid overdose reversal medication; 

23 ‘‘(2) encouraging pharmacies to dispense opioid 

24 overdose reversal medication pursuant to a standing 

25 order; 


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1 ‘‘(3) implementing best practices for persons au2 thorized to prescribe medication regarding— 

3 ‘‘(A) prescribing opioids for the treatment of 

4 chronic pain; 

5 ‘‘(B) co-prescribing opioid overdose reversal 

6 medication with opioids; and 

7 ‘‘(C) discussing the purpose and adminis8 tration of opioid overdose reversal medication 

9 with patients; 

10 ‘‘(4) developing or adapting training materials 

11 and methods for persons authorized to prescribe or 

12 dispense medication to use in educating the public re13 garding— 

14 ‘‘(A) when and how to administer opioid 

15 overdose reversal medication; and 

16 ‘‘(B) steps to be taken after administering 

17 opioid overdose reversal medication; and 

18 ‘‘(5) educating the public regarding— 

19 ‘‘(A) the public health benefits of opioid 

20 overdose reversal medication; and 

21 ‘‘(B) the availability of opioid overdose re22 versal medication without a person-specific pre23 scription. 

24 ‘‘(b) CERTAIN REQUIREMENT.—A grant may be made 

25 under this section only if the State involved has authorized 


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1 standing orders regarding opioid overdose reversal medica2 tion. 

3 ‘‘(c) PREFERENCE IN MAKING GRANTS.—In making 

4 grants under this section, the Secretary shall give preference 

5 to States that— 

6 ‘‘(1) have not issued standing orders regarding 

7 opioid overdose reversal medication; 

8 ‘‘(2) authorize standing orders that permit com9 munity-based organizations, substance abuse pro10 grams, or other nonprofit entities to acquire, dispense, 

11 or administer opioid overdose reversal medication; 

12 ‘‘(3) authorize standing orders that permit po13 lice, fire, or emergency medical services agencies to 

14 acquire and administer opioid overdose reversal medi15 cation; 

16 ‘‘(4) have a higher per capita rate of opioid 

17 overdoses than other applicant States; or 

18 ‘‘(5) meet any other criteria deemed appropriate 

19 by the Secretary. 

20 ‘‘(d) GRANT TERMS.— 

21 ‘‘(1) NUMBER.—A State may not receive more 

22 than 1 grant under this section. 

23 ‘‘(2) PERIOD.—A grant under this section shall 

24 be for a period of 3 years. 


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1 ‘‘(3) AMOUNT.—A grant under this section may 

2 not exceed $500,000. 

3 ‘‘(4) LIMITATION.—A State may use not more 

4 than 20 percent of a grant under this section for edu5 cating the public pursuant to subsection (a)(5). 

6 ‘‘(e) APPLICATIONS.—To be eligible to receive a grant 

7 under this section, a State shall submit an application to 

8 the Secretary in such form and manner and containing 

9 such information as the Secretary may require, including 

10 detailed proposed expenditures of grant funds. 

11 ‘‘(f) REPORTING.—Not later than 3 months after the 

12 Secretary disburses the first grant payment to any State 

13 under this section and every 6 months thereafter for 3 years, 

14 such State shall submit a report to the Secretary that in15 cludes the following: 

16 ‘‘(1) The name and ZIP Code of each pharmacy 

17 in the State that dispenses opioid overdose reversal 

18 medication under a standing order. 

19 ‘‘(2) The total number of opioid overdose reversal 

20 medication doses dispensed by each such pharmacy, 

21 specifying how many were dispensed with or without 

22 a person-specific prescription. 

23 ‘‘(3) The number of pharmacists in the State 

24 who have participated in training pursuant to sub25 section (a)(4). 


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1 ‘‘(g) DEFINITIONS.—In this section: 

2 ‘‘(1) OPIOID OVERDOSE REVERSAL MEDICA3 TION.—The term ‘opioid overdose reversal medication’ 

4 means any drug, including naloxone, that— 

5 ‘‘(A) blocks opioids from attaching to, but 

6 does not itself activate, opioid receptors; or 

7 ‘‘(B) inhibits the effects of opioids on opioid 

8 receptors. 

9 ‘‘(2) STANDING ORDER.—The term ‘standing 

10 order’ means a document prepared by a person au11 thorized to prescribe medication that permits another 

12 person to acquire, dispense, or administer medication 

13 without a person-specific prescription. 

14 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.— 

15 ‘‘(1) IN GENERAL.—To carry out this section, 

16 there is authorized to be appropriated $5,000,000 for 

17 the period of fiscal years 2017 through 2019. 

18 ‘‘(2) ADMINISTRATIVE COSTS.—Not more than 3 

19 percent of the amounts made available to carry out 

20 this section may be used by the Secretary for admin21 istrative expenses of carrying out this section.’’. 

22 SEC. 3. CUT-GO COMPLIANCE. 

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

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

25 before the period at the end the following: ‘‘(except such dolVerDate Sep 11 2014 01:17 May 11, 2016 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\H4586.RH H4586

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1 lar amount shall be reduced by $5,000,000 for fiscal year 

2 2017)’’. 


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Union Calendar No. 429 

114TH CONGRESS 

2D SESSION H. R. 4586 

[Report No. 114–555] 

A BILL 

To amend the Public Health Service Act to authorand for other purposes. medication without person-specific prescriptions, garding the dispensing of opioid overdose reversal ders and educating health care professionals re- ize grants to States for developing standing orMAY 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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