II 

113TH CONGRESS 

1ST SESSION S. 1657 

To reduce prescription drug misuse and abuse. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 6, 2013 

Mr. UDALL of New Mexico introduced the following bill; which was read twice 

and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To reduce prescription drug misuse and abuse. 

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 ‘‘Increasing the Safety 

5 of Prescription Drug Use Act of 2013’’. 

6 SEC. 2. PRESCRIPTION DRUG MONITORING PROGRAM. 

7 (a) CONTROLLED SUBSTANCE MONITORING PRO8 GRAM.—Section 399O of the Public Health Service Act 

9 (42 U.S.C. 243g–3) is amended— 

10 (1) in subsection (e), by adding at the end the 

11 following: 

12 ‘‘(5) The State shall— 


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1 ‘‘(A) ensure that the database— 

2 ‘‘(i) is interoperable with the con3 trolled substance monitoring program of 

4 other States and other Federal agencies 

5 and across appropriate State agencies, in6 cluding health agencies, as determined by 

7 the Secretary; 

8 ‘‘(ii) is interoperable with electronic 

9 health records and e-prescribing, where ap10 propriate; and 

11 ‘‘(iii) provides automatic, real-time or 

12 daily information about a patient when a 

13 practitioner (or the designee of a practi14 tioner, where permitted) requests informa15 tion about such patient; 

16 ‘‘(B) require practitioners to use State 

17 database information to help determine whether 

18 to prescribe or renew a prescription for a con19 trolled substance; and 

20 ‘‘(C) require dispensers, or their designees, 

21 where permitted, to enter data required by the 

22 Secretary, including the name of the patient, 

23 the date, and prescription dose, into the data24 base for a controlled substance. 


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1 ‘‘(6) Notwithstanding section 543 and any 

2 other provision of law, the data required to be en3 tered under paragraph (5)(C) shall include informa4 tion with respect to methadone that is dispensed to 

5 a patient, if applicable. 

6 ‘‘(7) The State shall ensure that— 

7 ‘‘(A) any person who receives patient infor8 mation through the database may disclose and 

9 use such information only to carry out the offi10 cial duties of that person with regard to the pa11 tient; and 

12 ‘‘(B) notwithstanding subsection (f)(1)(B), 

13 no information kept in accordance with a data14 base developed or maintained through a grant 

15 under this section may be used to conduct a 

16 criminal investigation or substantiate any crimi17 nal charges against a patient or to conduct any 

18 investigation of a patient relating to methadone 

19 use of the patient.’’; and 

20 (2) in subsection (n), by striking ‘‘To carry out 

21 this section’’ and all that follows through the period 

22 at the end and inserting ‘‘There are authorized to be 

23 appropriated for fiscal years 2014 through 2018 

24 such sums as may be necessary to carry out this sec25 tion.’’. 


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1 (b) CONFIDENTIALITY OF RECORDS.—Section 543(a) 

2 of the Public Health Service Act (42 U.S.C. 290dd–2(a)) 

3 is amended by inserting ‘‘or, with respect to methadone, 

4 as required under section 399O(e)(6)’’ before the period 

5 at the end. 

6 (c) REQUIREMENTS FOR FEDERAL HEALTH CARE

7 PROGRAMS.—Health care practitioners (as defined in 

8 paragraph (7) of section 399O(m) of the Public Health 

9 Service Act (42 U.S.C. 280g–3(m))) and dispensers (as 

10 defined in paragraph (4) of such section) who participate 

11 in or are employed by a Federal health care program or 

12 federally funded health care program, including the Indian 

13 Health Service, the Department of Veterans Affairs, the 

14 Department of Defense, the Federal Bureau of Prisons, 

15 the Medicare program under title XVIII of the Social Se16 curity Act (42 U.S.C. 1395 et seq.), a State Medicaid plan 

17 under title XIX of the Social Security Act (42 U.S.C. 

18 1396 et seq.), the Children’s Health Insurance Program 

19 under title XXI of the Social Security Act (42 U.S.C. 

20 1397aa et seq.), and Federally qualified health centers, 

21 shall use the databases of the controlled substance moni22 toring programs under section 399O of the Public Health 

23 Service Act (42 U.S.C. 280g–3), if such databases are 

24 available to the practitioner or dispenser. 


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1 SEC. 3. PILOT PROJECT. 

2 (a) IN GENERAL.—The Secretary of Health and 

3 Human Services (referred to in this subsection as the 

4 ‘‘Secretary’’) shall award grants to one or more States to 

5 carry out a 1-year pilot project to develop a standardized 

6 peer review process and methodology to review and evalu7 ate prescribing and pharmacy dispensing patterns, 

8 through a review of prescription drug monitoring pro9 grams (referred to in this section as ‘‘PDMP’’) in the 

10 States receiving such grants. 

11 (b) METHODOLOGY.—The recipients of a grant under 

12 this section shall develop a systematic, standardized meth13 odology to identify and investigate questionable or inap14 propriate prescribing and dispensing patterns of sub15 stances on schedule II or III under section 202 of the Con16 trolled Substances Act (21 U.S.C. 812). Such peer review 

17 methodology and prescribing and dispensing patterns shall 

18 be shared with the appropriate State health profession 

19 board. 

20 (c) REQUIREMENTS.—A State receiving a grant 

21 under this section shall— 

22 (1) with respect to controlled substances for 

23 which a prescriber is required to have a license 

24 issued by the Drug Enforcement Administration in 

25 order to prescribe such controlled substances, make 

26 the information with respect to such controlled subVerDate Mar 15 2010 23:40 Nov 07, 2013 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1657.IS S1657

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1 stances from the PDMP available to State regula2 tion and licensing boards; and 

3 (2) with respect to any other controlled sub4 stances, may make the information with respect to 

5 such controlled substances from the PDMP available 

6 to State regulation and licensing boards. 

7 (d) SUBGRANTEES.—A quality improvement organi8 zation with which the Secretary has entered into a con9 tract under part B of title XI of the Social Security Act 

10 may serve as the subgrantee under this subsection to de11 velop peer review processes as described in subsection (a). 

12 SEC. 4. PRESCRIPTION DRUG AND OTHER CONTROLLED 

13 SUBSTANCE ABUSE PREVENTION. 

14 Part P of title III of the Public Health Service Act 

15 (42 U.S.C. 280g) is amended by adding at the end the 

16 following: 

17 ‘‘SEC. 399V–6. PRESCRIPTION DRUG AND OTHER CON18 TROLLED SUBSTANCE ABUSE PREVENTION. 

19 ‘‘(a) TRAINING GRANTS.— 

20 ‘‘(1) IN GENERAL.—The Secretary shall award 

21 5-year grants to eligible entities to facilitate training 

22 in order to increase the capacity of health care pro23 viders to conduct patient screening and brief inter24 ventions, such as in health care settings to prevent 

25 the abuse of prescription drugs and other controlled 


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1 substances. The grant program under this section 

2 may be coordinated with the Screening Brief Inter3 vention and Referral to Treatment grant program of 

4 the Substance Abuse and Mental Health Services 

5 Administration, or other appropriate program. 

6 ‘‘(2) ELIGIBLE ENTITIES.—In this subsection, 

7 the term ‘eligible entity’ includes— 

8 ‘‘(A) States; 

9 ‘‘(B) continuing education entities, such as 

10 health profession boards or health accrediting 

11 bodies; and 

12 ‘‘(C) other appropriate health or profes13 sional education organizations or institutions. 

14 ‘‘(b) FEDERAL HEALTH CARE WORKERS.—Health 

15 care providers who participate in or are employed by a 

16 Federal health care program, including the Indian Health 

17 Service, the Department of Veterans Affairs, the Depart18 ment of Defense, the Federal Bureau of Prisons, the 

19 Medicare program under title XVIII of the Social Security 

20 Act (42 U.S.C. 1395 et seq.), a State Medicaid plan under 

21 title XIX of the Social Security Act (42 U.S.C. 1396 et 

22 seq.), the State Children’s Health Insurance Program 

23 under title XXI of the Social Security Act (42 U.S.C. 

24 1397aa et seq.), and Federally qualified health centers, 

25 shall screen patients for abuse of prescription drugs or 


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1 other controlled substances, conduct brief interventions, 

2 and provide referrals for known or suspected abuse of pre3 scription drugs or other controlled substances, as appro4 priate. 

5 ‘‘(c) EXPANSION OF PRESCRIBING AUTHORITY.— 

6 The Secretary, acting through the Administrator of the 

7 Health Resources and Services Administration, shall 

8 award grants to States for the purpose of evaluating the 

9 prospect of the health professions board of such States 

10 reviewing and expanding prescribing authorities of pro11 viders, such as advance practice nurses and physician’s as12 sistants, in order to control the abuse of prescription 

13 drugs or other controlled substances with respect to spe14 cific drugs and other controlled substances, as appro15 priate.’’. 

16 SEC. 5. PRESCRIPTION DRUG ABUSE TRAINING AND 

17 SCREENING PROGRAMS. 

18 (a) CONTINUING EDUCATION GRANTS.—The Sec19 retary of Health and Human Services (referred to in this 

20 section as the ‘‘Secretary’’) shall award grants to States 

21 to develop continuing education criteria and review proc22 esses that allow State health profession boards or State 

23 agencies to certify appropriate education and training for 

24 informed and safe prescribing of opioids and other drugs 


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1 on schedule II and III under section 202 of the Controlled 

2 Substances Act (21 U.S.C. 812). 

3 (b) REGISTRATION WITH DEA.—A practitioner who 

4 registers or renews a registration under section 303(f) of 

5 the Controlled Substances Act (21 U.S.C. 823(f)) shall, 

6 at the time of registering, certify to the Attorney General 

7 that such practitioner has completed continuing medical 

8 education— 

9 (1) in the case of a practitioner registering for 

10 the first time, with respect to prescription drug 

11 abuse; and 

12 (2) in the case of a practitioner renewing a reg13 istration, with respect to medical understanding of 

14 the proper use of all drugs listed in the schedules 

15 under section 202 of the Controlled Substances Act 

16 (21 U.S.C. 812). 

17 (c) SCREENING PROGRAM.—The Attorney General 

18 shall require that a practitioner registered under section 

19 303(f) of the Controlled Substances Act (21 U.S.C. 

20 823(f)) conduct patient screening for potential drug mis21 use or abuse before prescribing a drug listed on schedule 

22 II or III under section 202 of the Controlled Substances 

23 Act (21 U.S.C. 812), according to standards established 

24 by the applicable State licensing body. 


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1 SEC. 6. FDA REVIEW OF NALOXONE. 

2 The Secretary of Health and Human Services, acting 

3 through the Commissioner of Food and Drugs, shall con4 duct a review of naloxone to consider whether naloxone 

5 should cease to be subject to section 503(b) of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) and 

7 be available as a behind-the-counter drug, in order to in8 crease access of such drug to community-based organiza9 tions and street outreach organizations. 

10 SEC. 7. PRESCRIPTION DRUG DISPOSAL. 

11 The Secretary of Health and Human Services shall 

12 convene or coordinate with an existing entity an inter13 agency working group to encourage States and local gov14 ernments to increase opportunities for disposal of opiates, 

15 such as frequent ‘‘take-back programs’’ and fixed medi16 cine disposal sites at law enforcement public buildings, 

17 and to reduce opportunities for abuse of opiates, such as 

18 establishing opioid dispensing limits at hospital emergency 

19 departments. 

20 SEC. 8. GAO REPORT. 

21 The Comptroller General of the United States shall 

22 review prescription drug abuse programs and policies in 

23 Federal agencies and best practices with respect to pre24 scription drug abuse programs of the States and, not later 

25 than 18 months after the date of enactment of this Act, 


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1 shall issue a report to Congress on its findings and rec2 ommendations on ways to reduce prescription drug abuse. 

Æ 


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