II 

108TH CONGRESS 

2D SESSION S. 2288 

To amend the Public Health Service Act to assist States in establishing, 

maintaining, and improving systems to reduce the diversion and abuse 

of prescription drugs. 

IN THE SENATE OF THE UNITED STATES 

APRIL 6, 2004 

Ms. COLLINS introduced the following bill; which was read twice and referred 

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

A BILL 

To amend the Public Health Service Act to assist States 

in establishing, maintaining, and improving systems to 

reduce the diversion and abuse of prescription drugs. 

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 ‘‘Prescription Drug 

5 Stewardship Act’’. 

6 SEC. 2. PRESCRIPTION DRUG STEWARDSHIP. 

7 Title V of the Public Health Service Act (42 U.S.C. 

8 290aa et seq.) is amended by adding at the end the fol9 lowing: 
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1 ‘‘PART J—PRESCRIPTION DRUG STEWARDSHIP 

2 ‘‘SEC. 596. PURPOSE. 

3 ‘‘It is the purpose of this part to provide grants to 

4 assist States in establishing, maintaining, and improving 

5 systems to— 

6 ‘‘(1) track the distribution of prescription drugs 

7 from the prescribing health care providers to the 

8 pharmacy and, finally, to the patient; 

9 ‘‘(2) provide continuing education programs for 

10 health care providers concerning issues pertaining to 

11 prescription drug abuse among patients and col12 leagues; and 

13 ‘‘(3) provide education programs for the public 

14 on the problem of prescription drug diversion and 

15 abuse. 

16 ‘‘SEC. 596A. GRANT AUTHORITY. 

17 ‘‘The Secretary, acting through the Administrator of 

18 the Substance Abuse and Mental Health Services Admin19 istration, shall establish a program to award competitive 

20 grants, payable over 3 years, to States under sections 

21 596B through 596D to establish, maintain, and improve 

22 prescription drug monitoring and education. A State may 

23 receive a grant under one or more of such sections. 

24 ‘‘SEC. 596B. PRESCRIPTION DRUG MONITORING GRANTS. 

25 ‘‘(a) ELIGIBILITY.—To be eligible for a grant under 

26 this section, a State shall— 

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1 ‘‘(1) have in effect, or have enacted within 1 

2 year of receiving such a grant, laws or policies meet3 ing the requirements of subsection (c) that require 

4 the periodic and regular reporting by pharmacies of 

5 data on prescriptions filled; 

6 ‘‘(2) prepare and submit to the Secretary an 

7 application in accordance with subsection (b); and 

8 ‘‘(3) provide matching funds in accordance with 

9 subsection (f). 

10 ‘‘(b) APPLICATION.—An application under this sub11 section shall include— 

12 ‘‘(1) a description of the system that the State 

13 has established, or intends to establish, to ensure the 

14 effective monitoring of prescription drugs from pre15 scribing health care provider to pharmacy to patient; 

16 ‘‘(2) a description of the process by which the 

17 State has established, or intends to establish, the 

18 system described in paragraph (1) that includes the 

19 names of the participants, the timelines for such es20 tablishment, and any previous or ongoing efforts re21 lated to the establishment of a statewide system to 

22 reduce the diversion and abuse of prescription drugs; 

23 ‘‘(3) a description of the entity that is the des24 ignated State authority to collect and safeguard the 

25 information collected by the monitoring system; 

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1 ‘‘(4) an estimate, based upon the best available 

2 data, of the extent of prescription drug diversion 

3 and abuse in the State, of any trends relating to 

4 such diversion and abuse, of the types of prescrip5 tion drugs diverted, and of any local or regional di6 version and abuse patterns that have been detected; 

7 ‘‘(5) a description of existing systems in the 

8 State used to track the distribution of prescription 

9 drugs, including a description of how suspected 

10 cases of prescription fraud by health care providers, 

11 pharmacies, and patients are investigated and how 

12 data on the outcome of those investigations is pro13 vided to the system; 

14 ‘‘(6) a description of the current status of inter15 agency collaboration among the State’s medical and 

16 pharmacy oversight boards, law-enforcement offi17 cials, and substance-abuse authorities that dem18 onstrates a foundation on which the State can build 

19 a collaborative system that fully protects patient 

20 confidentiality; 

21 ‘‘(7) a description of the current status of infor22 mation-sharing regarding prescribing practices with 

23 other States and of efforts made to improve such in24 formation-sharing; 

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1 ‘‘(8) a description of the existing, or planned, 

2 protections to ensure that the prescription moni3 toring program does not restrict access to drugs by 

4 legitimate patients; 

5 ‘‘(9) a description of the plan of the State for 

6 financing the monitoring system at the conclusion of 

7 the 3-year grant period; 

8 ‘‘(10) a description of the source of the State 

9 matching funds required under subsection (e); and 

10 ‘‘(11) any other information determined appro11 priate by the Secretary. 

12 ‘‘(c) REQUIRED STATE LAW OR POLICIES.—A State 

13 law or policy meets the requirements of this subsection 

14 if such law or policy— 

15 ‘‘(1) is developed by a collaborative process that 

16 is conducted by a commission of stakeholders, in17 cluding representatives of the public, health care 

18 providers, pharmacists, law enforcement officials, 

19 substance-abuse treatment providers, and others de20 termined appropriate by the Secretary; 

21 ‘‘(2) ensures that the handling of information 

22 collected under the law or policy is used in compli23 ance with the regulations promulgated under section 

24 264(c) of the Health Insurance Portability and Ac25 countability Act of 1996; 

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1 ‘‘(3) requires that on a regular basis, each 

2 pharmacy in the State report to the State agency 

3 designated under paragraph (3) information on each 

4 prescription filled by the agency, including— 

5 ‘‘(A) the identity of the prescribing health 

6 care provider; 

7 ‘‘(B) the identity of the patient; 

8 ‘‘(C) the drug prescribed; and 

9 ‘‘(D) the amount of drug prescribed; 

10 ‘‘(4) ensures that the information provided 

11 under paragraph (3) shall— 

12 ‘‘(A) be available, upon request, to the 

13 health care provider and patient involved; and 

14 ‘‘(B) be used only in compliance with the 

15 confidentiality guidelines contained in the regu16 lations promulgated under section 264(c) of the 

17 Health Insurance Portability and Accountability 

18 Act of 1996; and 

19 ‘‘(5) complies with regulations promulgated by 

20 the Secretary concerning the reporting of informa21 tion concerning activities under a grant under this 

22 section activities during the period of the grant and 

23 at the conclusion of grant funding. 

24 ‘‘(d) PRIORITY.—In awarding grants under this sec25 tion, the Secretary shall give priority to those States that 

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1 have in effect, or that enact within 1 year of receiving 

2 such a grant, a law— 

3 ‘‘(1) providing for a prescription-monitoring 

4 system that is based upon the model created by the 

5 National Association of State Controlled Substance 

6 Authorities; and 

7 ‘‘(2) that requires that Internet pharmacies be 

8 licensed in the State and participate in the moni9 toring program. 

10 ‘‘(e) USE OF FUNDS.—Amounts awarded under a 

11 grant under this section shall be used by the State for 

12 the purposes of establishing, maintaining, and improving 

13 a prescription monitoring system, to ensure the account14 ability of such system, and to evaluate the performance 

15 of such system. 

16 ‘‘(f) REQUIRED STATE MATCH.—To be eligible to re17 ceive a grant under this section a State shall agree that, 

18 with respect to the costs to be incurred by the State in 

19 carrying out the activities for which the grant was award20 ed, the State will make available (in cash or in kind) non21 Federal contributions toward such costs in an amount 

22 equal to— 

23 ‘‘(1) for the first fiscal year of payments under 

24 the grant, not less than 20 percent of such costs ($2 

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1 for each $10 of Federal funds provided in the 

2 grant); 

3 ‘‘(2) for the second fiscal year of payments 

4 under the grant, not less than 40 percent of such 

5 costs ($4 for each $10 of Federal funds provided in 

6 the grant); and 

7 ‘‘(3) for the third fiscal year of payments under 

8 the grant, not less than 60 percent of such costs ($6 

9 for each $10 of Federal funds provided in the 

10 grant). 

11 ‘‘SEC. 596C. HEALTH CARE PROVIDER MENTORING GRANTS. 

12 ‘‘(a) PURPOSE.—The purpose of grants awarded 

13 under this section is to assist States in developing and 

14 implementing health care provider education and training 

15 programs to increase awareness among providers of issues 

16 pertaining to prescription-drug diversion and abuse by pa17 tients and colleagues. 

18 ‘‘(b) ELIGIBILITY.—To be eligible for a grant under 

19 this section, a State shall— 

20 ‘‘(1) have in effect, or implement within 1 year 

21 of receiving such a grant, a program that meets the 

22 requirements of subsection (d) that provides edu23 cation and training to health care providers con24 cerning prescription-drug diversion and abuse by pa25 tients and colleagues; 

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1 ‘‘(2) prepare and submit to the Secretary an 

2 application in accordance with subsection (c); and 

3 ‘‘(3) provide matching funds in accordance with 

4 subsection (g). 

5 ‘‘(c) APPLICATION.—An application under this sub6 section shall include— 

7 ‘‘(1) a description of the education and training 

8 programs of the type described in subsection (d) 

9 that the State has or intends to develop; 

10 ‘‘(2) a description of the collaborative effort by 

11 individual health care providers and pharmacists, 

12 medical, nursing and pharmacy associations, edu13 cational institutions, the State substance abuse au14 thority, and other relevant entities to develop the 

15 education and training plan; 

16 ‘‘(3) a description of the process by which men17 tors under the education and training plan will be 

18 recruited, selected, and trained; 

19 ‘‘(4) a description of the curriculum developed 

20 by the collaborative effort and of the methods that 

21 mentors will use to deliver it to colleagues, such as 

22 one-on-one or group sessions, seminars, or grand 

23 rounds; 

24 ‘‘(5) a description of the compensation, if any, 

25 that will be provided to mentors under the plan; 

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1 ‘‘(6) a description of the collaboration with 

2 State medical, nursing, and pharmacy associations 

3 that will result in the awarding of continuing edu4 cation units to participants in activities under the 

5 plan; 

6 ‘‘(7) a description of the current status of pro7 grams, either conducted by the State or by profes8 sional associations, to educate health care providers 

9 on drug-abuse issues; 

10 ‘‘(8) a description of the plan of the State for 

11 financing the education and training activities under 

12 this section at the conclusion of the 3-year grant pe13 riod; 

14 ‘‘(9) a description of the source of the State 

15 matching funds required under subsection (f); 

16 ‘‘(10) a description of the entity that will ad17 minister the program, which may include the State 

18 substance abuse authority, a State medical, phar19 macy or nursing association, an educational institu20 tion, or any other entity deemed appropriate by the 

21 Secretary; and 

22 ‘‘(11) any other information determined appro23 priate by the Secretary. 

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1 ‘‘(d) STATE EDUCATION AND TRAINING PROGRAM.— 

2 An education and training program meets the require3 ments of this subsection if such program— 

4 ‘‘(1) is designed to provide willing health care 

5 providers and pharmacists with specialized education 

6 and training concerning issues including recognizing 

7 drug-seeking behavior and addiction or dependency 

8 among patients and colleagues, trends in drug 

9 abuse, and current research on drug side effects and 

10 interactions; 

11 ‘‘(2) is developed through collaboration among 

12 substance-abuse, education, medical, nursing, phar13 macy, and other relevant professionals; 

14 ‘‘(3) ensures that information is provided in 

15 compliance with the confidentiality guidelines con16 tained in the regulations promulgated under section 

17 264(c) of the Health Insurance Portability and Ac18 countability Act of 1996; and 

19 ‘‘(4) complies with regulations to be promul20 gated by the Secretary of the Department of Health 

21 and Human Services concerning reporting require22 ments under the program both during the period of 

23 the grant and upon the termination of grant fund24 ing. 

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1 ‘‘(e) PRIORITY.—In awarding grants under this sec2 tion, the Secretary shall give priority to those States that, 

3 with respect to activities under the education and training 

4 program under this section— 

5 ‘‘(1) have a collaborative body of stakeholders 

6 to review the operations and effectiveness of the pro7 gram on an ongoing basis and to make adjustments 

8 to the program as necessary; 

9 ‘‘(2) ensure that the pool of mentors includes 

10 adequate representation by health care providers 

11 from rural, inner city, and other at-risk regions; and 

12 ‘‘(3) ensure that the mentoring efforts include 

13 rural, inner city, and other at-risk communities. 

14 ‘‘(f) USE OF FUNDS.—Amounts awarded under a 

15 grant under this section shall be used by the State for 

16 the purposes of establishing and operating a program to 

17 mentor health care providers on issues relating to pre18 scription drug diversion and abuse, of ensuring its ac19 countability, and of evaluating its performance. 

20 ‘‘(g) REQUIRED STATE MATCH.—To be eligible to re21 ceive a grant under this section a State shall agree that, 

22 with respect to the costs to be incurred by the State in 

23 carrying out the activities for which the grant was award24 ed, the State will make available (in cash or in kind) nonVerDate mar 24 2004 21:47 Apr 08, 2004 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2288.IS S2288
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1 Federal contributions toward such costs in an amount 

2 equal to— 

3 ‘‘(1) for the first fiscal year of payments under 

4 the grant, not less than 20 percent of such costs ($2 

5 for each $10 of Federal funds provided in the 

6 grant); 

7 ‘‘(2) for the second fiscal year of payments 

8 under the grant, not less than 40 percent of such 

9 costs ($4 for each $10 of Federal funds provided in 

10 the grant); and 

11 ‘‘(3) for the third fiscal year of payments under 

12 the grant, not less than 60 percent of such costs ($6 

13 for each $10 of Federal funds provided in the 

14 grant). 

15 ‘‘SEC. 596D. PUBLIC EDUCATION GRANTS. 

16 ‘‘(a) PURPOSE.—The purpose of grants awarded 

17 under this section is to assist States in developing and 

18 implementing programs to increase public awareness of 

19 the problem of prescription-drug diversion and abuse. 

20 ‘‘(b) ELIGIBILITY.—To be eligible for a grant under 

21 this section, a State shall— 

22 ‘‘(1) have in effect, or implement within 1 year 

23 of receiving such a grant, a program that meets the 

24 requirements of subsection (d) and that provides 

25 public education relating to prescription drug diverVerDate mar 24 2004 21:47 Apr 08, 2004 Jkt 019200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S2288.IS S2288
14 

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1 sion and abuse and the potential for addiction, de2 pendency, and undesirable health outcomes; 

3 ‘‘(2) prepare and submit to the Secretary an 

4 application in accordance with subsection (c); and 

5 ‘‘(3) provide matching funds in accordance with 

6 subsection (g). 

7 ‘‘(c) APPLICATION.—An application under this sub8 section shall include— 

9 ‘‘(1) a description of the education program 

10 that the State is implementing, or intends to imple11 ment, to increase public awareness of the problems 

12 associated with prescription drug diversion and 

13 abuse, including information on the various popu14 lation groups that are or will be targeted under the 

15 program and the educational methods that are or 

16 will be employed for each such population group; 

17 ‘‘(2) a description of the current status of pre18 scription drug diversion and abuse in the state and 

19 current efforts to curtail it; 

20 ‘‘(3) a description of the methods by which the 

21 effectiveness of the program under this section will 

22 be measured; 

23 ‘‘(4) a description of the State agency or non24 profit organization that will administer the program 

25 funded under this section; 

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1 ‘‘(5) a description of the collaborative effort 

2 that was used to develop the program; 

3 ‘‘(6) a description of the plan of the State for 

4 financing the program under this section at the con5 clusion of the 3-year grant period; 

6 ‘‘(7) a description of the source of the State 

7 matching funds required under subsection (f); and 

8 ‘‘(8) any other information determined appro9 priate by the Secretary. 

10 ‘‘(d) STATE PUBLIC EDUCATION PROGRAM.—A pub11 lic education program meets the requirements of this sub12 section if such program is developed through collaboration 

13 among substance-abuse authorities, law-enforcement, edu14 cation, and health care entities, members of the public, 

15 and other relevant entities; 

16 ‘‘(e) PRIORITY.—In awarding grants under this sec17 tion, the Secretary shall give priority to those States that, 

18 with respect to activities under the program under this 

19 section— 

20 ‘‘(1) have a collaborative body of stakeholders 

21 to review the operations and effectiveness of the pro22 gram on an on-going basis and to make adjustments 

23 to the program as necessary; and 

24 ‘‘(2) ensure that the educational efforts include 

25 rural, inner city, and other at-risk communities. 

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1 ‘‘(f) USE OF FUNDS.—Amounts awarded under a 

2 grant under this section shall be used by the State for 

3 the purposes of establishing and operating a program to 

4 increase public awareness of the problem of prescription 

5 drug diversion and abuse. 

6 ‘‘(g) REQUIRED STATE MATCH.—To be eligible to re7 ceive a grant under this section a State shall agree that, 

8 with respect to the costs to be incurred by the State in 

9 carrying out the activities for which the grant was award10 ed, the State will make available (in cash or in kind) non11 Federal contributions toward such costs in an amount 

12 equal to— 

13 ‘‘(1) for the first fiscal year of payments under 

14 the grant, not less than 20 percent of such costs ($2 

15 for each $10 of Federal funds provided in the 

16 grant); 

17 ‘‘(2) for the second fiscal year of payments 

18 under the grant, not less than 40 percent of such 

19 costs ($4 for each $10 of Federal funds provided in 

20 the grant); and 

21 ‘‘(3) for the third fiscal year of payments under 

22 the grant, not less than 60 percent of such costs ($6 

23 for each $10 of Federal funds provided in the 

24 grant). 

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1 ‘‘SEC. 596E. REGULATIONS AND EVALUATION. 

2 ‘‘(a) REGULATIONS.—The Secretary is authorized to 

3 promulgate regulations as determined necessary to carry 

4 out the purposes of the part. 

5 ‘‘(b) EVALUATION.—Not later than 2 years after the 

6 date of enactment of this part, the General Accounting 

7 Office shall conduct a study and submit a report to Con8 gress concerning how the States have used the amounts 

9 provided under this part and whether such activities have 

10 been effective in reducing the diversion and abuse of pre11 scription drugs. 

12 ‘‘SEC. 596F. AUTHORIZATION OF APPROPRIATIONS. 

13 ‘‘There is authorized to be appropriated to carry out 

14 this part, $20,000,000 for each of fiscal years 2005 

15 through 2007.’’. 

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