II 

Calendar No. 440 

114TH CONGRESS 

2D SESSION S. 480 

To amend and reauthorize the controlled substance monitoring program under 

section 399O of the Public Health Service Act. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 12, 2015 

Mrs. SHAHEEN (for herself, Mr. TOOMEY, Mr. DURBIN, Mr. SESSIONS, Mr. 

BROWN, Mrs. FEINSTEIN, Mrs. GILLIBRAND, Mr. MANCHIN, Mr. MARKEY, Mr. SCHUMER, Ms. WARREN, Mr. BLUMENTHAL, and Ms. COLLINS) 

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

Committee on Health, Education, Labor, and Pensions 

APRIL 27, 2016 

Reported by Mr. ALEXANDER, with an amendment 

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

A BILL 

To amend and reauthorize the controlled substance monitoring program under section 399O of the Public Health 

Service Act. 

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


sradovich on DSK3TPTVN1PROD with BILLS
2 

•S 480 RS

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘National All Schedules 

3 Prescription Electronic Reporting Reauthorization Act of 

4 2015’’. 

5 SEC. 2. AMENDMENT TO PURPOSE. 

6 Paragraph (1) of section 2 of the National All Sched7 ules Prescription Electronic Reporting Act of 2005 (Public 

8 Law 109–60) is amended to read as follows: 

9 ‘‘(1) foster the establishment of State-adminis10 tered controlled substance monitoring systems in 

11 order to ensure that— 

12 ‘‘(A) health care providers have access to 

13 the accurate, timely prescription history infor14 mation that they may use as a tool for the early 

15 identification of patients at risk for addiction in 

16 order to initiate appropriate medical interven17 tions and avert the tragic personal, family, and 

18 community consequences of untreated addiction; 

19 and 

20 ‘‘(B) appropriate law enforcement, regu21 latory, and State professional licensing authori22 ties have access to prescription history informa23 tion for the purposes of investigating drug di24 version and prescribing and dispensing prac25 tices of errant prescribers or pharmacists; and’’. 


sradovich on DSK3TPTVN1PROD with BILLS
3 

•S 480 RS

1 SEC. 3. AMENDMENTS TO CONTROLLED SUBSTANCE MONI2 TORING PROGRAM. 

3 Section 399O of the Public Health Service Act (42 

4 U.S.C. 280g–3) is amended— 

5 (1) in subsection (a)(1)— 

6 (A) in subparagraph (A), by striking ‘‘or’’; 

7 (B) in subparagraph (B), by striking the 

8 period at the end and inserting ‘‘; or’’; and 

9 (C) by adding at the end the following: 

10 ‘‘(C) to maintain and operate an existing 

11 State-controlled substance monitoring pro12 gram.’’; 

13 (2) by amending subsection (b) to read as fol14 lows: 

15 ‘‘(b) MINIMUM REQUIREMENTS.—The Secretary 

16 shall maintain and, as appropriate, supplement or revise 

17 (after publishing proposed additions and revisions in the 

18 Federal Register and receiving public comments thereon) 

19 minimum requirements for criteria to be used by States 

20 for purposes of clauses (ii), (v), (vi), and (vii) of subsection 

21 (c)(1)(A).’’; 

22 (3) in subsection (c)— 

23 (A) in paragraph (1)(B)— 

24 (i) in the matter preceding clause (i), 

25 by striking ‘‘(a)(1)(B)’’ and inserting 

26 ‘‘(a)(1)(B) or (a)(1)(C)’’; 


sradovich on DSK3TPTVN1PROD with BILLS
4 

•S 480 RS

1 (ii) in clause (i), by striking ‘‘program 

2 to be improved’’ and inserting ‘‘program to 

3 be improved or maintained’’; 

4 (iii) by redesignating clauses (iii) and 

5 (iv) as clauses (iv) and (v), respectively; 

6 (iv) by inserting after clause (ii), the 

7 following: 

8 ‘‘(iii) a plan to apply the latest ad9 vances in health information technology in 

10 order to incorporate prescription drug 

11 monitoring program data directly into the 

12 workflow of prescribers and dispensers to 

13 ensure timely access to patients’ controlled 

14 prescription drug history;’’; 

15 (v) in clause (iv) (as so redesignated), 

16 by inserting before the semicolon the fol17 lowing: ‘‘and at least one health informa18 tion technology system such as electronic 

19 health records, health information ex20 changes, and e-prescribing systems’’; and 

21 (vi) in clause (v) (as so redesignated), 

22 by striking ‘‘public health’’ and inserting 

23 ‘‘public health or public safety’’; 

24 (B) in paragraph (3)— 


sradovich on DSK3TPTVN1PROD with BILLS
5 

•S 480 RS

1 (i) by striking ‘‘If a State that sub2 mits’’ and inserting the following: 

3 ‘‘(A) IN GENERAL.—If a State that sub4 mits’’; 

5 (ii) by inserting before the period at 

6 the end ‘‘and include timelines for full im7 plementation of such interoperability. The 

8 State shall also describe the manner in 

9 which it will achieve interoperability be10 tween its monitoring program and health 

11 information technology systems, as allow12 able under State law, and include timelines 

13 for the implementation of such interoper14 ability’’; and 

15 (iii) by adding at the end the fol16 lowing: 

17 ‘‘(B) MONITORING OF EFFORTS.—The 

18 Secretary shall monitor State efforts to achieve 

19 interoperability, as described in subparagraph 

20 (A).’’; and 

21 (C) in paragraph (5)— 

22 (i) by striking ‘‘implement or im23 prove’’ and inserting ‘‘establish, improve, 

24 or maintain’’; and 


sradovich on DSK3TPTVN1PROD with BILLS
6 

•S 480 RS

1 (ii) by adding at the end the fol2 lowing: ‘‘The Secretary shall redistribute 

3 any funds that are so returned among the 

4 remaining grantees under this section in 

5 accordance with the formula described in 

6 subsection (a)(2)(B).’’; 

7 (4) in subsection (d)— 

8 (A) in the matter preceding paragraph 

9 (1)— 

10 (i) by striking ‘‘In implementing or 

11 improving’’ and all that follows through 

12 ‘‘(a)(1)(B)’’ and inserting ‘‘In establishing, 

13 improving, or maintaining a controlled sub14 stance monitoring program under this sec15 tion, a State shall comply, or with respect 

16 to a State that applies for a grant under 

17 subparagraph (B) or (C) of subsection 

18 (a)(1)’’; and 

19 (ii) by striking ‘‘public health’’ and in20 serting ‘‘public health or public safety’’; 

21 and 

22 (B) by adding at the end the following: 

23 ‘‘(5) The State shall report on interoperability 

24 with the controlled substance monitoring program of 

25 Federal agencies, where appropriate, interoperability 


sradovich on DSK3TPTVN1PROD with BILLS
7 

•S 480 RS

1 with health information technology systems such as 

2 electronic health records, health information ex3 changes, and e-prescribing, where appropriate, and 

4 whether or not the State provides automatic, real5 time or daily information about a patient when a 

6 practitioner (or the designee of a practitioner, where 

7 permitted) requests information about such pa8 tient.’’; 

9 (5) in subsections (e), (f)(1), and (g), by strik10 ing ‘‘implementing or improving’’ each place it ap11 pears and inserting ‘‘establishing, improving, or 

12 maintaining’’; 

13 (6) in subsection (f)— 

14 (A) in paragraph (1)(B) by striking ‘‘mis15 use of a schedule II, III, or IV substance’’ and 

16 inserting ‘‘misuse of a controlled substance in17 cluded in schedule II, III, or IV of section 

18 202(c) of the Controlled Substance Act’’; and 

19 (B) by adding at the end the following: 

20 ‘‘(3) EVALUATION AND REPORTING.—Subject 

21 to subsection (g), a State receiving a grant under 

22 subsection (a) shall provide the Secretary with ag23 gregate data and other information determined by 

24 the Secretary to be necessary to enable the Sec25 retary— 


sradovich on DSK3TPTVN1PROD with BILLS
8 

•S 480 RS

1 ‘‘(A) to evaluate the success of the State’s 

2 program in achieving its purposes; or 

3 ‘‘(B) to prepare and submit the report to 

4 Congress required by subsection (k)(2). 

5 ‘‘(4) RESEARCH BY OTHER ENTITIES.—A de6 partment, program, or administration receiving non7 identifiable information under paragraph (1)(D) 

8 may make such information available to other enti9 ties for research purposes.’’; 

10 (7) by striking subsection (k); 

11 (8) by redesignating subsections (h) through (j) 

12 as subsections (i) through (k), respectively; 

13 (9) in subsections (c)(1)(A)(iv) and (d)(4), by 

14 striking ‘‘subsection (h)’’ each place it appears and 

15 inserting ‘‘subsection (i)’’; 

16 (10) by inserting after subsection (g) the fol17 lowing: 

18 ‘‘(h) EDUCATION AND ACCESS TO THE MONITORING

19 SYSTEM.—A State receiving a grant under subsection (a) 

20 shall take steps to— 

21 ‘‘(1) facilitate prescriber and dispenser use of 

22 the State’s controlled substance monitoring system; 

23 and 

24 ‘‘(2) educate prescribers and dispenser on the 

25 benefits of the system both to them and society.’’; 


sradovich on DSK3TPTVN1PROD with BILLS
9 

•S 480 RS

1 (11) in subsection (k)(2)(A), as redesignated— 

2 (A) in clause (ii), by striking ‘‘or affected’’ 

3 and inserting ‘‘, established or strengthened ini4 tiatives to ensure linkages to substance use dis5 order services, or affected’’; and 

6 (B) in clause (iii), by striking ‘‘including 

7 an assessment’’ and inserting ‘‘between con8 trolled substance monitoring programs and 

9 health information technology systems, and in10 cluding an assessment’’; 

11 (12) in subsection (l)(1), by striking ‘‘establish12 ment, implementation, or improvement’’ and insert13 ing ‘‘establishment, improvement, or maintenance’’; 

14 (13) in subsection (m)(8), by striking ‘‘and the 

15 District of Columbia’’ and inserting ‘‘, the District 

16 of Columbia, and any commonwealth or territory of 

17 the United States’’; and 

18 (14) by amending subsection (n), to read as fol19 lows: 

20 ‘‘(o) AUTHORIZATION OF APPROPRIATIONS.—To 

21 carry out this section, there are authorized to be appro22 priated $7,000,000 for each of fiscal years 2016 through 

23 2020.’’. 


sradovich on DSK3TPTVN1PROD with BILLS
10 

•S 480 RS

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘National All Schedules 

3 Prescription Electronic Reporting Reauthorization Act of 

4 2016’’. 

5 SEC. 2. AMENDMENT TO PURPOSE. 

6 Paragraph (1) of section 2 of the National All Sched7 ules Prescription Electronic Reporting Act of 2005 (Public 

8 Law 109–60) is amended to read as follows: 

9 ‘‘(1) foster the establishment of State-adminis10 tered controlled substance monitoring systems in 

11 order to ensure that health care providers have access 

12 to the accurate, timely prescription history informa13 tion that they may use as a tool for the early identi14 fication of patients at risk for addiction in order to 

15 initiate appropriate medical interventions and avert 

16 the tragic personal, family, and community con17 sequences of untreated addiction; and’’. 

18 SEC. 3. AMENDMENTS TO CONTROLLED SUBSTANCE MONI19 TORING PROGRAM. 

20 Section 399O of the Public Health Service Act (42 

21 U.S.C. 280g–3) is amended— 

22 (1) in subsection (a)(1)— 

23 (A) in the matter preceding subparagraph 

24 (A), by inserting ‘‘, in consultation with the Ad25 ministrator of the Substance Abuse and Mental 

26 Health Services Administration and Director of 


sradovich on DSK3TPTVN1PROD with BILLS
11 

•S 480 RS

1 the Centers for Disease Control and Prevention,’’ 

2 after ‘‘the Secretary’’; 

3 (B) in subparagraph (A), by striking ‘‘or’’; 

4 (C) in subparagraph (B), by striking the 

5 period at the end and inserting ‘‘; or’’; and 

6 (D) by adding at the end the following: 

7 ‘‘(C) to maintain an existing State-con8 trolled substance monitoring program.’’; 

9 (2) by amending subsection (b) to read as fol10 lows: 

11 ‘‘(b) MINIMUM REQUIREMENTS.—The Secretary shall 

12 maintain and, as appropriate, supplement or revise (after 

13 publishing proposed additions and revisions in the Federal 

14 Register and receiving public comments thereon) minimum 

15 requirements for criteria to be used by States for purposes 

16 of clauses (ii), (v), (vi), and (vii) of subsection (c)(1)(A).’’; 

17 (3) in subsection (c)— 

18 (A) in paragraph (1)(B)— 

19 (i) in the matter preceding clause (i), 

20 by striking ‘‘(a)(1)(B)’’ and inserting 

21 ‘‘(a)(1)(B) or (a)(1)(C)’’; 

22 (ii) in clause (i), by striking ‘‘program 

23 to be improved’’ and inserting ‘‘program to 

24 be improved or maintained’’; 


sradovich on DSK3TPTVN1PROD with BILLS
12 

•S 480 RS

1 (iii) by redesignating clauses (iii) and 

2 (iv) as clauses (iv) and (v), respectively; 

3 (iv) by inserting after clause (ii), the 

4 following: 

5 ‘‘(iii) a plan to apply the latest ad6 vances in health information technology, to 

7 the extent practicable, in order to incor8 porate prescription drug monitoring pro9 gram data directly into the workflow of pre10 scribers and dispensers to ensure timely ac11 cess to patients’ controlled prescription drug 

12 history;’’; 

13 (v) in clause (iv) (as so redesig14 nated)— 

15 (I) by inserting before the semi16 colon the following: ‘‘and at least one 

17 health information technology system 

18 such as electronic health records, health 

19 information exchanges, and e-pre20 scribing systems’’; and 

21 (II) by striking ‘‘and’’ after the 

22 semicolon; 

23 (vi) in clause (v) (as so redesig24 nated)— 


sradovich on DSK3TPTVN1PROD with BILLS
13 

•S 480 RS

1 (I) by striking ‘‘public health’’ 

2 and inserting ‘‘public health or safety’’; 

3 and 

4 (II) by striking the period and in5 serting ‘‘; and’’; and 

6 (vii) by adding at the end the fol7 lowing: 

8 ‘‘(vi) information, where applicable, on 

9 how the controlled substance monitoring 

10 program jointly works with the applicant’s 

11 respective State substance abuse agency to 

12 ensure information collected and main13 tained by the controlled substance moni14 toring program is used to inform the provi15 sion of clinically appropriate substance use 

16 disorder services to individuals in need.’’; 

17 (B) in paragraph (3)— 

18 (i) by striking ‘‘If a State that sub19 mits’’ and inserting the following: 

20 ‘‘(A) IN GENERAL.—If a State that sub21 mits’’; 

22 (ii) by inserting before the period at 

23 the end ‘‘and include timelines for full im24 plementation of such interoperability. The 

25 State shall also describe the manner in 


sradovich on DSK3TPTVN1PROD with BILLS
14 

•S 480 RS

1 which it will achieve interoperability be2 tween its monitoring program and health 

3 information technology systems, as allow4 able under State law, and include timelines 

5 for the implementation of such interoper6 ability’’; and 

7 (iii) by adding at the end the fol8 lowing: 

9 ‘‘(B) MONITORING OF EFFORTS.—The Sec10 retary shall monitor State efforts to achieve 

11 interoperability, as described in subparagraph 

12 (A).’’; and 

13 (C) in paragraph (5)— 

14 (i) by striking ‘‘implement or im15 prove’’ and inserting ‘‘establish, improve, or 

16 maintain’’; and 

17 (ii) by adding at the end the following: 

18 ‘‘The Secretary shall redistribute any funds 

19 that are so returned among the remaining 

20 grantees under this section in accordance 

21 with the formula described in subsection 

22 (a)(2)(B).’’; 

23 (4) in subsection (d)— 

24 (A) in the matter preceding paragraph 

25 (1)— 


sradovich on DSK3TPTVN1PROD with BILLS
15 

•S 480 RS

1 (i) by striking ‘‘In implementing or 

2 improving’’ and all that follows through 

3 ‘‘(a)(1)(B)’’ and inserting ‘‘In establishing, 

4 improving, or maintaining a controlled 

5 substance monitoring program under this 

6 section, a State shall comply, or with re7 spect to a State that applies for a grant 

8 under subparagraph (B) or (C) of sub9 section (a)(1)’’; and 

10 (ii) by striking ‘‘public health’’ and in11 serting ‘‘public health or safety’’; and 

12 (B) by adding at the end the following: 

13 ‘‘(5) The State shall report on interoperability 

14 with the controlled substance monitoring program of 

15 Federal agencies, where appropriate, interoperability 

16 with health information technology systems such as 

17 electronic health records, health information ex18 changes, and e-prescribing, where appropriate, and 

19 whether or not the State provides automatic, up-to20 date, or daily information about a patient when a 

21 practitioner (or the designee of a practitioner, where 

22 permitted) requests information about such patient.’’; 

23 (5) in subsections (e), (f)(1), and (g), by striking 

24 ‘‘implementing or improving’’ each place it appears 


sradovich on DSK3TPTVN1PROD with BILLS
16 

•S 480 RS

1 and inserting ‘‘establishing, improving, or maintain2 ing’’; 

3 (6) in subsection (f)— 

4 (A) in paragraph (1)— 

5 (i) in subparagraph (B), by striking 

6 ‘‘misuse of a schedule II, III, or IV sub7 stance’’ and inserting ‘‘misuse of a con8 trolled substance’’; and 

9 (ii) in subparagraph (D)— 

10 (I) by inserting ‘‘a State sub11 stance abuse agency,’’ after ‘‘State 

12 health department,’’; and 

13 (II) by striking ‘‘such department, 

14 program, or administration’’ each 

15 place it appears and inserting ‘‘such 

16 department, program, agency, or ad17 ministration’’ in each such place; and 

18 (B) by adding at the end the following: 

19 ‘‘(3) EVALUATION AND REPORTING.—Subject to 

20 subsection (g), a State receiving a grant under sub21 section (a) shall provide the Secretary with aggregate 

22 data to enable the Secretary— 

23 ‘‘(A) to evaluate the success of the State’s 

24 program in achieving its purposes; or 


sradovich on DSK3TPTVN1PROD with BILLS
17 

•S 480 RS

1 ‘‘(B) to prepare and submit the report to 

2 Congress required by subsection (k)(2). 

3 ‘‘(4) RESEARCH BY OTHER ENTITIES.—A depart4 ment, program, agency, or administration receiving 

5 nonidentifiable information under paragraph (1)(D) 

6 may make such information available to other entities 

7 for research purposes.’’; 

8 (7) by striking subsection (k); 

9 (8) by redesignating subsections (h) through (j) 

10 as subsections (i) through (k), respectively; 

11 (9) in subsections (c)(1)(A)(iv) and (d)(4), by 

12 striking ‘‘subsection (h)’’ each place it appears and 

13 inserting ‘‘subsection (i)’’; 

14 (10) by inserting after subsection (g) the fol15 lowing: 

16 ‘‘(h) EDUCATION AND ACCESS TO THE MONITORING

17 SYSTEM.—A State receiving a grant under subsection (a) 

18 shall take steps to— 

19 ‘‘(1) facilitate prescriber and dispenser use of the 

20 State’s controlled substance monitoring system, to the 

21 extent practicable; and 

22 ‘‘(2) educate prescribers and dispensers on the 

23 benefits of the system.’’; 

24 (11) in subsection (k)(2)(A), as so redesignated— 


sradovich on DSK3TPTVN1PROD with BILLS
18 

•S 480 RS

1 (A) in clause (ii), by striking ‘‘or affected’’ 

2 and inserting ‘‘, established or strengthened ini3 tiatives to ensure linkages to substance use dis4 order services, or affected’’; and 

5 (B) in clause (iii), by striking ‘‘including 

6 an assessment’’ and inserting ‘‘and between con7 trolled substance monitoring programs and 

8 health information technology systems, including 

9 an assessment’’; 

10 (12) in subsection (l)(1), by striking ‘‘establish11 ment, implementation, or improvement’’ and insert12 ing ‘‘establishment, improvement, or maintenance’’; 

13 (13) in subsection (m)(8), by striking ‘‘and the 

14 District of Columbia’’ and inserting ‘‘, the District of 

15 Columbia, and any commonwealth or territory of the 

16 United States’’; and 

17 (14) by amending subsection (n) to read as fol18 lows: 

19 ‘‘(n) AUTHORIZATION OF APPROPRIATIONS.—To carry 

20 out this section, there are authorized to be appropriated 

21 such sums as may be necessary for each of fiscal years 2017 

22 through 2021.’’. 


sradovich on DSK3TPTVN1PROD with BILLS

sradovich on DSK3TPTVN1PROD with BILLS
Calendar No. 440 

114TH CONGRESS 

2D SESSION S. 480 

A BILL 

To amend and reauthorize the controlled substance 

Public Health Service Act. monitoring program under section 399O of the 

APRIL 27, 2016 

Reported with an amendment 


sradovich on DSK3TPTVN1PROD with BILLS