II 

Calendar No. 187 

109TH CONGRESS 

1ST SESSION S. 518 

[Report No. 109–117] 

To provide for the establishment of a controlled substance monitoring program 

in each State. 

IN THE SENATE OF THE UNITED STATES 

MARCH 3, 2005 

Mr. SESSIONS (for himself, Mr. DURBIN, Mr. KENNEDY, Mr. DODD, Mr. ALEXANDER, Mr. VITTER, Mr. BURR, and Mr. TALENT) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

JULY 29, 2005 

Reported by Mr. ENZI, with an amendment 

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

A BILL 

To provide for the establishment of a controlled substance 

monitoring program in each State. 

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 ‘‘National All Schedules 

5 Prescription Electronic Reporting Act of 2005’’. 
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1 SEC. 2. CONTROLLED SUBSTANCE MONITORING PROGRAM. 

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

3 (42 U.S.C. 280g et seq.) is amended by adding after sec4 tion 399N the following: 

5 ‘‘SEC. 399O. CONTROLLED SUBSTANCE MONITORING PRO6 GRAM. 

7 ‘‘(a) GRANTS.— 

8 ‘‘(1) IN GENERAL.—Each fiscal year, the Sec9 retary shall award a grant to each State with an ap10 plication approved under this section to enable the 

11 State— 

12 ‘‘(A) to establish and implement a State 

13 controlled substance monitoring program; or 

14 ‘‘(B) to make improvements to an existing 

15 State controlled substance monitoring program. 

16 ‘‘(2) DETERMINATION OF AMOUNT.— 

17 ‘‘(A) MINIMUM AMOUNT.—In making pay18 ments under a grant under paragraph (1) for 

19 a fiscal year, the Secretary shall allocate to 

20 each State with an application approved under 

21 this section an amount that equals 0.5 percent 

22 of the amount appropriated to carry out this 

23 section for that fiscal year. 

24 ‘‘(B) ADDITIONAL AMOUNTS.—In making 

25 payments under a grant under paragraph (1) 

26 for a fiscal year, the Secretary shall allocate to 
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1 each State with an application approved under 

2 this section an additional amount which bears 

3 the same ratio to the amount appropriated to 

4 carry out this section for that fiscal year and 

5 remaining after amounts are made available 

6 under paragraph (1) as the number of phar7 macies of the State bears to the number of 

8 pharmacies of all States with applications ap9 proved under this section (as determined by the 

10 Secretary), except that the Secretary may ad11 just the amount allocated to a State under this 

12 subparagraph after taking into consideration 

13 the budget cost estimate for the State’s con14 trolled substance monitoring program. 

15 ‘‘(3) TERM OF CERTAIN GRANTS.—Grants 

16 awarded under this section shall be for a term of 18 

17 months. 

18 ‘‘(b) DEVELOPMENT OF MINIMUM STANDARDS AND

19 RECOMMENDATIONS.— 

20 ‘‘(1) IN GENERAL.—Not later than 30 days 

21 after the date of enactment of this section, the Sec22 retary shall— 

23 ‘‘(A) develop minimum standards for use 

24 by States in submitting their proposed stand-
4 

•S 518 RS 

1 ards under clauses (ii), (v), (vi), and (vii) of 

2 subsection (c)(1)(A); and 

3 ‘‘(B) develop recommendations with re4 spect to appropriate penalties for the provision 

5 or use of information in violation of applicable 

6 Federal, State, or local law or regulation. 

7 ‘‘(2) REPORT.—Not later than 1 year after the 

8 date of enactment of this section, the Secretary shall 

9 report to Congress on the recommendations devel10 oped under paragraph (1)(B) and the extent to 

11 which existing penalties meet, exceed, or fall short of 

12 such recommendations. 

13 ‘‘(c) APPLICATION APPROVAL PROCESS.— 

14 ‘‘(1) IN GENERAL.—To be eligible to receive a 

15 grant under this section, a State shall submit, and 

16 have approved in accordance with paragraph (2), an 

17 application to the Secretary at such time, in such 

18 manner, and containing such assurances and infor19 mation as the Secretary may reasonably require. 

20 Each such application shall include— 

21 ‘‘(A) with respect to a State that intends 

22 to use funds under the grant as provided for in 

23 subsection (a)(1)(A)— 
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1 ‘‘(i) a budget cost estimate for the 

2 controlled substance monitoring program 

3 to be implemented under the grant; 

4 ‘‘(ii) proposed standards for security 

5 for information handling and for the data6 base maintained by the State under sub7 section (e) generally including efforts to 

8 use appropriate encryption technology or 

9 other appropriate technology to protect the 

10 security of such information; 

11 ‘‘(iii) an agreement to adopt, to the 

12 extent practicable, applicable health infor13 mation technology standards, as deter14 mined by the Secretary; 

15 ‘‘(iv) proposed standards for meeting 

16 the uniform electronic format requirement 

17 of subsection (h); 

18 ‘‘(v) proposed standards for avail19 ability of information and limitation on ac20 cess to program personnel; 

21 ‘‘(vi) proposed standards for access to 

22 the database, and procedures to ensure 

23 database accuracy; 

24 ‘‘(vii) proposed standards for the pro25 vision of information, including a descrip-
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1 tion of the certification process to be ap2 plied to requests for information under 

3 subsection (f); 

4 ‘‘(viii) proposed penalties for the pro5 vision or use of information in violation of 

6 applicable Federal, State, or local law or 

7 regulation; and 

8 ‘‘(ix) assurances of compliance with 

9 all other requirements of this section; or 

10 ‘‘(B) with respect to a State that intends 

11 to use funds under the grant as provided for in 

12 subsection (a)(1)(B)— 

13 ‘‘(i) a budget cost estimate for the 

14 controlled substance monitoring program 

15 to be improved under the grant; 

16 ‘‘(ii) a plan for ensuring that the 

17 State controlled substance monitoring pro18 gram is in compliance with the standards 

19 and penalty requirements described in 

20 clauses (ii) through (viii) of subparagraph 

21 (A); 

22 ‘‘(iii) a plan to enable the State con23 trolled substance monitoring program to 

24 achieve interoperability with at least one 
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1 other State controlled substance moni2 toring program, including— 

3 ‘‘(I) the technical achievement of 

4 information sharing between the two 

5 programs; 

6 ‘‘(II) measures to ensure that 

7 interoperability activities carried out 

8 under this subsection are in compli9 ance with the requirements of sub10 paragraph (A); 

11 ‘‘(III) measures to ensure that 

12 proposed standards for information 

13 access will be enforced for shared in14 formation; and 

15 ‘‘(IV) the completion of interstate 

16 legal compacts necessary for such in17 formation sharing; and 

18 ‘‘(iv) assurances of compliance with 

19 all other requirements of this section or a 

20 statement describing why such compliance 

21 is not feasible or is contrary to the best in22 terests of public health in such State. 

23 ‘‘(2) APPROVAL OR DISAPPROVAL.— 

24 ‘‘(A) IN GENERAL.—Not later than 90 

25 days after the submission by a State of an ap-
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1 plication under paragraph (1), the Secretary 

2 shall approve or disapprove the application, or 

3 request additional information as provided 

4 under subparagraph (C). The Secretary may 

5 disapprove an application that contains a state6 ment described in paragraph (1)(B)(iv), or re7 quest additional information with respect to 

8 such a statement, if the Secretary determines 

9 that the approval of such application would re10 sult in the implementation of a State program 

11 that substantially fails to meet the goals and 

12 objectives of this section. 

13 ‘‘(B) APPROVAL.—The Secretary shall ap14 prove an application submitted under para15 graph (1) only if— 

16 ‘‘(i) the plans contained in the appli17 cation meet the standards developed by the 

18 Secretary under subsection (b); and 

19 ‘‘(ii) the State demonstrates to the 

20 Secretary that the State will establish and 

21 implement or improve a controlled sub22 stance monitoring program in accordance 

23 with this section. 

24 ‘‘(C) ADDITIONAL INFORMATION.—With 

25 respect to an application submitted by a State 
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1 under paragraph (1), the Secretary may, during 

2 the 90-day period referred to in subparagraph 

3 (A), request that the State provide additional 

4 information with respect to the State program. 

5 If such a request is made after the expiration 

6 of the 60-day period beginning on the date on 

7 which the application is submitted, the period 

8 under subparagraph (A) for approval or dis9 approval by the Secretary shall be extended for 

10 an additional 30 days. 

11 ‘‘(3) WITHDRAWAL OF AUTHORIZATION.—Ex12 cept to the extent that a State is excused from com13 pliance with a requirement or standard as a result 

14 of the approval by the Secretary of a statement 

15 under paragraph (1)(B)(iv) or under subsection (d), 

16 if a State fails to implement or improve a controlled 

17 substance monitoring program in accordance with 

18 this section or fails to comply with the standards de19 veloped under this subsection— 

20 ‘‘(A) the Secretary shall give notice of the 

21 failure to the State; and 

22 ‘‘(B) if the State fails to take corrective 

23 action within a reasonable period of time, the 

24 Secretary shall withdraw any approval of the 

25 State’s application under this section. 
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1 ‘‘(4) VOLUNTARY DISCONTINUANCE.—A fund2 ing agreement for the receipt of a grant under this 

3 section is that the State involved will give a reason4 able period of notice to the Secretary before ceasing 

5 to implement or operate a controlled substance mon6 itoring program under this section. The Secretary 

7 shall determine the period of notice that is reason8 able for purposes of this paragraph. 

9 ‘‘(5) RETURN OF FUNDS.—If the Secretary 

10 withdraws approval of a State’s application under 

11 this section, or the State chooses to cease to imple12 ment or improve a controlled substance monitoring 

13 program under this section, a funding agreement for 

14 the receipt of a grant under this section is that the 

15 State will return to the Secretary an amount which 

16 bears the same ratio to the overall grant as the re17 maining time period for expending the grant funds 

18 bears to the overall time period for expending the 

19 grant (as specified by the Secretary at the time of 

20 the grant). 

21 ‘‘(d) REPORTING REQUIREMENTS.—In implementing 

22 or improving a controlled substance monitoring program 

23 under this section, a State shall comply, or with respect 

24 to a State that applies for a grant under subsection 

25 (a)(1)(B) submit to the Secretary for approval a state-
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1 ment of why such compliance is not feasible or is contrary 

2 to the best interests of public health in such State, with 

3 the following: 

4 ‘‘(1) The State shall require dispensers to re5 port to such State each dispensing in the State of 

6 a controlled substance to an ultimate user not later 

7 than 1 week after the date of such dispensing. 

8 ‘‘(2) The State may exclude from the reporting 

9 requirement of this subsection— 

10 ‘‘(A) the direct administration of a con11 trolled substance to the body of an ultimate 

12 user; 

13 ‘‘(B) the dispensing of a controlled sub14 stance in a quantity limited to an amount ade15 quate to treat the ultimate user involved for 48 

16 hours or less; or 

17 ‘‘(C) the administration or dispensing of a 

18 controlled substance in accordance with any 

19 other exclusion identified by the Secretary for 

20 purposes of this paragraph. 

21 ‘‘(3) The information to be reported under this 

22 subsection with respect to the dispensing of a con23 trolled substance shall include the following: 

24 ‘‘(A) Drug Enforcement Administration 

25 Registration Number of the dispenser. 
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1 ‘‘(B) Drug Enforcement Administration 

2 Registration Number and name of the practi3 tioner who prescribed the drug. 

4 ‘‘(C) Name, address, and telephone num5 ber of the ultimate user or such contact infor6 mation of the ultimate user as the Secretary de7 termines appropriate. 

8 ‘‘(D) Identification of the drug by a na9 tional drug code number. 

10 ‘‘(E) Quantity dispensed. 

11 ‘‘(F) Estimated number of days for which 

12 such quantity should last. 

13 ‘‘(G) Number of refills ordered. 

14 ‘‘(H) Whether the drug was dispensed as 

15 a refill of a prescription or as a first-time re16 quest. 

17 ‘‘(I) Date of the dispensing. 

18 ‘‘(J) Date of origin of the prescription. 

19 ‘‘(4) The State shall require dispensers to re20 port information under this section in accordance 

21 with the electronic format specified by the Secretary 

22 under subsection (h), except that the State may 

23 waive the requirement of such format with respect to 

24 an individual dispenser. 
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1 ‘‘(e) DATABASE.—In implementing or improving a 

2 controlled substance monitoring program under this sec3 tion, a State shall comply with the following: 

4 ‘‘(1) The State shall establish and maintain an 

5 electronic database containing the information re6 ported to the State under subsection (d). 

7 ‘‘(2) The database must be searchable by any 

8 field or combination of fields. 

9 ‘‘(3) The State shall include reported informa10 tion in the database in a manner consistent with 

11 standards established by the Secretary, with appro12 priate safeguards for ensuring the accuracy and 

13 completeness of the database. 

14 ‘‘(4) The State shall take appropriate security 

15 measures to protect the integrity of, and access to, 

16 the database. 

17 ‘‘(f) PROVISION OF INFORMATION.— 

18 ‘‘(1) IN GENERAL.—Subject to subsection (g), 

19 in implementing or improving a controlled substance 

20 monitoring program under this section, a State may 

21 provide information from the database established 

22 under subsection (e) and, in the case of a request 

23 under paragraph (3), summary statistics of such in24 formation, in response to a request by— 
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1 ‘‘(A) a practitioner (or the agent thereof) 

2 who certifies, under the procedures determined 

3 by the State, that the requested information is 

4 for the purpose of providing medical or pharma5 ceutical treatment or evaluating the need for 

6 such treatment to a bona fide current patient; 

7 ‘‘(B) any local, State, or Federal law en8 forcement, narcotics control, licensure, discipli9 nary, or program authority, who certifies, under 

10 the procedures determined by the State, that 

11 the requested information is related to an indi12 vidual investigation or proceeding involving the 

13 unlawful diversion or misuse of a schedule II, 

14 III, or IV substance, and such information will 

15 further the purpose of the investigation or as16 sist in the proceeding; 

17 ‘‘(C) the controlled substance monitoring 

18 program of another State or group of States 

19 with whom the State has established an inter20 operability agreement; 

21 ‘‘(D) any agent of the Department of 

22 Health and Human Services, a State medicaid 

23 program, a State health department, or the 

24 Drug Enforcement Administration who certifies 

25 that the requested information is necessary for 
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1 research to be conducted by such department, 

2 program, or administration, respectively, and 

3 the intended purpose of the research is related 

4 to a function committed to such department, 

5 program, or administration by law that is not 

6 investigative in nature; or 

7 ‘‘(E) an agent of the State agency or enti8 ty of another State that is responsible for the 

9 establishment and maintenance of that State’s 

10 controlled substance monitoring program, who 

11 certifies that— 

12 ‘‘(i) the State has an application ap13 proved under this section; and 

14 ‘‘(ii) the requested information is for 

15 the purpose of implementing the State’s 

16 controlled substance monitoring program 

17 under this section. 

18 ‘‘(2) DRUG DIVERSION.—A State that elects to 

19 exercise its authority to notify the appropriate au20 thorities responsible for drug diversion investigations 

21 if information in the database maintained by the 

22 State under subsection (e) is suggestive of an unlaw23 ful diversion or misuse of a controlled substance, is 

24 encouraged to develop any such notification program 

25 in consultation with representatives of the medical 
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1 community, including physicians and pharmacists or 

2 other interested stakeholders. 

3 ‘‘(g) LIMITATIONS.—In implementing or improving a 

4 controlled substance monitoring program under this sec5 tion, a State— 

6 ‘‘(1) shall make reasonable efforts to limit the 

7 information provided pursuant to a valid request 

8 under subsection (f)(1) to the minimum necessary to 

9 accomplish the intended purpose of the request; and 

10 ‘‘(2) shall limit information provided in re11 sponse to a request under subsection (f)(1)(D) to in12 formation provided in a form and manner that pre13 vents the identification of a provider or patient. 

14 ‘‘(h) ELECTRONIC FORMAT.—The Secretary shall 

15 specify a uniform electronic format for the reporting, shar16 ing, and provision of information under this section. 

17 ‘‘(i) RULES OF CONSTRUCTION.— 

18 ‘‘(1) FUNCTIONS OTHERWISE AUTHORIZED BY

19 LAW.—Nothing in this section shall be construed to 

20 restrict the ability of any authority, including any 

21 local, State, or Federal law enforcement, narcotics 

22 control, licensure, disciplinary, or program authority, 

23 to perform functions otherwise authorized by law. 

24 ‘‘(2) NO PREEMPTION.—Nothing in this section 

25 shall be construed as preempting any State law, ex-
17 

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1 cept that no such law may relieve any person of a 

2 requirement otherwise applicable under this Act. 

3 ‘‘(3) ADDITIONAL PRIVACY PROTECTIONS.— 

4 Nothing in this section shall be construed as pre5 empting any State from imposing any additional pri6 vacy protections. 

7 ‘‘(4) CERTAIN CONFIDENTIALITY REQUIRE8 MENTS.—Nothing in this section shall be construed 

9 as superseding the confidentiality requirements of 

10 programs defined by and subject to part 2 of title 

11 42, Code of Federal Regulations. 

12 ‘‘(5) NO FEDERAL PRIVATE CAUSE OF AC13 TION.—Nothing in this section shall be construed to 

14 create a Federal private cause of action. 

15 ‘‘(j) RELATION TO HIPAA.—Except to the extent in16 consistent with this section, the provision of information 

17 pursuant to subsection (f) and the subsequent transfer of 

18 such information are subject to any requirement that 

19 would otherwise apply under the regulations promulgated 

20 pursuant to section 264(c) of the Health Insurance Port21 ability and Accountability Act of 1996. 

22 ‘‘(k) STUDY.—Not later than 2 years after the date 

23 of the enactment of this section, the Secretary shall— 

24 ‘‘(1) complete a study that— 
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1 ‘‘(A) determines the progress of States in 

2 establishing and implementing controlled sub3 stance monitoring programs under this section; 

4 ‘‘(B) determines the progress of States in 

5 achieving interoperability between controlled 

6 substance monitoring programs, including an 

7 assessment of technical and legal barriers to 

8 such activities and recommendations for ad9 dressing these barriers; 

10 ‘‘(C) determines the feasibility of imple11 menting a real-time electronic controlled sub12 stance monitoring program, including the costs 

13 associated with establishing such a program; 

14 and 

15 ‘‘(D) provides an analysis of the privacy 

16 protections in place for the information re17 ported to the controlled substance monitoring 

18 program in each State receiving a grant for the 

19 establishment or operation of such program, 

20 and a comparison to the privacy requirements 

21 that apply to covered entities under regulations 

22 promulgated pursuant to section 264(c) of the 

23 Health Insurance Portability and Accountability 

24 Act of 1996, along with any recommendations 
19 

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1 for additional requirements for protection of 

2 this information; and 

3 ‘‘(E) determines the feasibility of imple4 menting technological alternatives to centralized 

5 data storage, such as peer-to-peer file sharing 

6 or data pointer systems, in controlled substance 

7 monitoring programs and the potential for such 

8 alternatives to enhance the privacy and security 

9 of individually identifiable data; and 

10 ‘‘(2) submit a report to the Congress on the re11 sults of the study. 

12 ‘‘(l) ADVISORY COUNCIL.— 

13 ‘‘(1) ESTABLISHMENT.—A State may establish 

14 an advisory council to assist in the establishment, 

15 implementation, or improvement of a controlled sub16 stance monitoring program under this section. 

17 ‘‘(2) SENSE OF CONGRESS.—It is the sense of 

18 the Congress that, in establishing an advisory coun19 cil under this subsection, a State should consult with 

20 appropriate professional boards and other interested 

21 parties. 

22 ‘‘(m) DEFINITIONS.—For purposes of this section: 

23 ‘‘(1) The term ‘bona fide patient’ means an in24 dividual who is a patient of the dispenser or practi25 tioner involved. 
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1 ‘‘(2) The term ‘controlled substance’ means a 

2 drug that is included in schedule II, III, or IV of 

3 section 202(c) of the Controlled Substance Act. 

4 ‘‘(3) The term ‘dispense’ means to deliver a 

5 controlled substance to an ultimate user by, or pur6 suant to the lawful order of, a practitioner, irrespec7 tive of whether the dispenser uses the Internet or 

8 other means to effect such delivery. 

9 ‘‘(4) The term ‘dispenser’ means a physician, 

10 pharmacist, or other individual who dispenses a con11 trolled substance to an ultimate user. 

12 ‘‘(5) The term ‘interoperability’ with respect to 

13 a State controlled substance monitoring program 

14 means the ability of the program to electronically 

15 share reported information, including each of the re16 quired report components described in subsection 

17 (d), with another State if the information concerns 

18 either the dispensing of a controlled substance to an 

19 ultimate user who resides in such other State, or the 

20 dispensing of a controlled substance prescribed by a 

21 practitioner whose principal place of business is lo22 cated in such other State. 

23 ‘‘(6) The term ‘nonidentifiable information’ 

24 means information that is provided in a form and 
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1 manner that prevents the identification of a provider 

2 or patient. 

3 ‘‘(7) The term ‘practitioner’ means a physician, 

4 dentist, veterinarian, scientific investigator, phar5 macy, hospital, or other person licensed, registered, 

6 or otherwise permitted, by the United States or the 

7 jurisdiction in which he or she practices or does re8 search, to distribute, dispense, conduct research with 

9 respect to, administer, or use in teaching or chemical 

10 analysis, a controlled substance in the course of pro11 fessional practice or research. 

12 ‘‘(8) The term ‘State’ means each of the 50 

13 States and the District of Columbia. 

14 ‘‘(9) The term ‘ultimate user’ means a person 

15 who has lawfully obtained, and who possesses, a con16 trolled substance for his or her own use, for the use 

17 of a member of his or her household, or for the use 

18 of an animal owned by him or her or by a member 

19 of his or her household. 

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

21 carry out this section, there are authorized to be appro22 priated— 

23 ‘‘(1) $25,000,000 for each of fiscal years 2006 

24 and 2007; and 
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1 ‘‘(2) $15,000,000 for each of fiscal years 2008, 

2 2009, and 2010.’’. 

3 SECTION 1. SHORT TITLE. 

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

5 Prescription Electronic Reporting Act of 2005’’. 

6 SEC. 2. PURPOSE. 

7 It is the purpose of this Act to— 

8 (1) foster the establishment of State-administered 

9 prescription drug monitoring systems in order to en10 sure that health care providers have access to the ac11 curate, timely prescription history information that 

12 they may use as a tool for the early identification of 

13 patients at risk for addiction in order to initiate ap14 propriate medical interventions and avert the tragic 

15 personal, family, and community consequences of un16 treated addiction; and 

17 (2) establish, based on the experiences of existing 

18 State control substance monitoring programs, a set of 

19 best practices to guide the establishment of new State 

20 programs and the improvement of existing programs. 

21 SEC. 3. CONTROLLED SUBSTANCE MONITORING PROGRAM. 

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

23 (42 U.S.C. 280g et seq.) is amended by adding after section 

24 399N the following: 
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1 ‘‘SEC. 399O. CONTROLLED SUBSTANCE MONITORING PRO2 GRAM. 

3 ‘‘(a) GRANTS.— 

4 ‘‘(1) IN GENERAL.—Each fiscal year, the Sec5 retary shall award a grant to each State with an ap6 plication approved under this section to enable the 

7 State— 

8 ‘‘(A) to establish and implement a State 

9 controlled substance monitoring program; or 

10 ‘‘(B) to make improvements to an existing 

11 State controlled substance monitoring program. 

12 ‘‘(2) DETERMINATION OF AMOUNT.— 

13 ‘‘(A) MINIMUM AMOUNT.—In making pay14 ments under a grant under paragraph (1) for a 

15 fiscal year, the Secretary shall allocate to each 

16 State with an application approved under this 

17 section an amount that equals 1.0 percent of the 

18 amount appropriated to carry out this section 

19 for that fiscal year. 

20 ‘‘(B) ADDITIONAL AMOUNTS.—In making 

21 payments under a grant under paragraph (1) 

22 for a fiscal year, the Secretary shall allocate to 

23 each State with an application approved under 

24 this section an additional amount which bears 

25 the same ratio to the amount appropriated to 

26 carry out this section for that fiscal year and re-
24 

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1 maining after amounts are made available under 

2 paragraph (1) as the number of pharmacies of 

3 the State bears to the number of pharmacies of 

4 all States with applications approved under this 

5 section (as determined by the Secretary), except 

6 that the Secretary may adjust the amount allo7 cated to a State under this subparagraph after 

8 taking into consideration the budget cost esti9 mate for the State’s controlled substance moni10 toring program. 

11 ‘‘(3) TERM OF CERTAIN GRANTS.—Grants 

12 awarded under this section shall be obligated in the 

13 year in which funds are allotted. 

14 ‘‘(b) DEVELOPMENT OF MINIMUM REQUIREMENTS.— 

15 Prior to awarding a grant under this section, but not later 

16 than 6 months after the date on which funds are first appro17 priated under this section, the Secretary shall identify min18 imum requirements for use by States in submitting their 

19 proposed criteria under clauses (ii), (v), (vi), and (vii) of 

20 subsection (c)(1)(A). 

21 ‘‘(c) APPLICATION APPROVAL PROCESS.— 

22 ‘‘(1) IN GENERAL.—To be eligible to receive a 

23 grant under this section, a State shall submit an ap24 plication to the Secretary at such time, in such man25 ner, and containing such assurances and information 
25 

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1 as the Secretary may reasonably require. Each such 

2 application shall include— 

3 ‘‘(A) with respect to a State that intends to 

4 use funds under the grant as provided for in sub5 section (a)(1)(A)— 

6 ‘‘(i) a budget cost estimate for the con7 trolled substance monitoring program to be 

8 implemented under the grant; 

9 ‘‘(ii) criteria for security for informa10 tion handling and for the database main11 tained by the State under subsection (e) 

12 generally including efforts to use appro13 priate encryption technology or other ap14 propriate technology to protect the security 

15 of such information; 

16 ‘‘(iii) an agreement to adopt health in17 formation interoperability standards, in18 cluding health vocabulary and messaging 

19 standards, that are consistent with any such 

20 standards generated or identified by the 

21 Secretary or his or her designee; 

22 ‘‘(iv) criteria for meeting the uniform 

23 electronic format requirement of subsection 

24 (h); 
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1 ‘‘(v) criteria for availability of infor2 mation and limitation on access to program 

3 personnel; 

4 ‘‘(vi) criteria for access to the database, 

5 and procedures to ensure database accuracy; 

6 ‘‘(vii) criteria for the use and disclo7 sure of information, including a description 

8 of the certification process to be applied to 

9 requests for information under subsection 

10 (f); 

11 ‘‘(viii) penalties for the unauthorized 

12 use and disclosure of information in viola13 tion of applicable State law or regulation; 

14 and 

15 ‘‘(ix) assurances of compliance with all 

16 other requirements of this section; or 

17 ‘‘(B) with respect to a State that intends to 

18 use funds under the grant as provided for in sub19 section (a)(1)(B)— 

20 ‘‘(i) a budget cost estimate for the con21 trolled substance monitoring program to be 

22 improved under the grant; 

23 ‘‘(ii) a plan for ensuring that the State 

24 controlled substance monitoring program is 

25 in compliance with the criteria and penalty 
27 

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1 requirements described in clauses (ii) 

2 through (viii) of subparagraph (A); 

3 ‘‘(iii) a plan to enable the State con4 trolled substance monitoring program to 

5 achieve interoperability with at least one 

6 other State controlled substance monitoring 

7 program; and 

8 ‘‘(iv) assurances of compliance with all 

9 other requirements of this section or a state10 ment describing why such compliance is not 

11 feasible or is contrary to the best interests 

12 of public health in such State. 

13 ‘‘(2) STATE LEGISLATION.—As part of an appli14 cation under paragraph (1), the Secretary shall re15 quire the State to have enacted legislation or regula16 tions to permit the implementation of the State con17 trolled substance monitoring program and the imposi18 tion of appropriate penalties for the unauthorized use 

19 and disclosure of information maintained in such 

20 program. 

21 ‘‘(3) INTEROPERABILITY.—If a State that sub22 mits an application under this subsection geographi23 cally borders another State that is operating a con24 trolled substances monitoring program under sub25 section (a)(1) on the date of such application, and 
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1 such applicant State has not achieved interoperability 

2 for purposes of information sharing between its moni3 toring program and the monitoring program of such 

4 border State, such applicant State shall, as part of 

5 the plan under paragraph (1)(B)(iii), describe the 

6 manner in which the applicant State will achieve 

7 interoperability between the monitoring programs of 

8 such States. 

9 ‘‘(4) RETURN OF FUNDS.—If the Secretary with10 draws approval of a State’s application under this 

11 section, or the State chooses to cease to implement or 

12 improve a controlled substance monitoring program 

13 under this section, a funding agreement for the re14 ceipt of a grant under this section is that the State 

15 will return to the Secretary an amount which bears 

16 the same ratio to the overall grant as the remaining 

17 time period for expending the grant funds bears to the 

18 overall time period for expending the grant (as speci19 fied by the Secretary at the time of the grant). 

20 ‘‘(d) REPORTING REQUIREMENTS.—In implementing 

21 or improving a controlled substance monitoring program 

22 under this section, a State shall comply, or with respect 

23 to a State that applies for a grant under subsection 

24 (a)(1)(B) submit to the Secretary for approval a statement 

25 of why such compliance is not feasible or is contrary to 
29 

•S 518 RS 

1 the best interests of public health in such State, with the 

2 following: 

3 ‘‘(1) The State shall require dispensers to report 

4 to such State each dispensing in the State of a con5 trolled substance to an ultimate user not later than 

6 1 week after the date of such dispensing. 

7 ‘‘(2) The State may exclude from the reporting 

8 requirement of this subsection— 

9 ‘‘(A) the direct administration of a con10 trolled substance to the body of an ultimate user; 

11 ‘‘(B) the dispensing of a controlled sub12 stance in a quantity limited to an amount ade13 quate to treat the ultimate user involved for 48 

14 hours or less; or 

15 ‘‘(C) the administration or dispensing of a 

16 controlled substance in accordance with any 

17 other exclusion identified by the Secretary for 

18 purposes of this paragraph. 

19 ‘‘(3) The information to be reported under this 

20 subsection with respect to the dispensing of a con21 trolled substance shall include the following: 

22 ‘‘(A) Drug Enforcement Administration 

23 Registration Number (or other identifying num24 ber used in lieu of such Registration Number) of 

25 the dispenser. 
30 

•S 518 RS 

1 ‘‘(B) Drug Enforcement Administration 

2 Registration Number (or other identifying num3 ber used in lieu of such Registration Number) 

4 and name of the practitioner who prescribed the 

5 drug. 

6 ‘‘(C) Name, address, and telephone number 

7 of the ultimate user or such contact information 

8 of the ultimate user as the Secretary determines 

9 appropriate. 

10 ‘‘(D) Identification of the drug by a na11 tional drug code number. 

12 ‘‘(E) Quantity dispensed. 

13 ‘‘(F) Number of refills ordered. 

14 ‘‘(G) Whether the drug was dispensed as a 

15 refill of a prescription or as a first-time request. 

16 ‘‘(H) Date of the dispensing. 

17 ‘‘(I) Date of origin of the prescription. 

18 ‘‘(4) The State shall require dispensers to report 

19 information under this section in accordance with the 

20 electronic format specified by the Secretary under 

21 subsection (h), except that the State may waive the re22 quirement of such format with respect to an indi23 vidual dispenser that is unable to submit such infor24 mation by electronic means. 
31 

•S 518 RS 

1 ‘‘(e) DATABASE.—In implementing or improving a 

2 controlled substance monitoring program under this section, 

3 a State shall comply with the following: 

4 ‘‘(1) The State shall establish and maintain an 

5 electronic database containing the information re6 ported to the State under subsection (d). 

7 ‘‘(2) The database must be searchable by any 

8 field or combination of fields. 

9 ‘‘(3) The State shall include reported informa10 tion in the database in a manner consistent with cri11 teria established by the Secretary, with appropriate 

12 safeguards for ensuring the accuracy and complete13 ness of the database. 

14 ‘‘(4) The State shall take appropriate security 

15 measures to protect the integrity of, and access to, the 

16 database. 

17 ‘‘(f) USE AND DISCLOSURE OF INFORMATION.— 

18 ‘‘(1) IN GENERAL.—Subject to subsection (g), in 

19 implementing or improving a controlled substance 

20 monitoring program under this section, a State may 

21 disclose information from the database established 

22 under subsection (e) and, in the case of a request 

23 under subsection (f)(1)(D), summary statistics of such 

24 information, only in response to a request by— 
32 

•S 518 RS 

1 ‘‘(A) a practitioner (or the agent thereof) 

2 who certifies, under the procedures determined by 

3 the State, that the requested information is for 

4 the purpose of providing medical or pharma5 ceutical treatment or evaluating the need for 

6 such treatment to a bona fide current patient; 

7 ‘‘(B) any local, State, or Federal law en8 forcement, narcotics control, licensure, discipli9 nary, or program authority, who certifies, under 

10 the procedures determined by the State, that the 

11 requested information is related to an individual 

12 investigation or proceeding involving the unlaw13 ful diversion or misuse of a schedule II, III, or 

14 IV substance, and such information will further 

15 the purpose of the investigation or assist in the 

16 proceeding; 

17 ‘‘(C) the controlled substance monitoring 

18 program of another State or group of States with 

19 whom the State has established an interoper20 ability agreement; 

21 ‘‘(D) any agent of the Department of Health 

22 and Human Services, a State medicaid pro23 gram, a State health department, or the Drug 

24 Enforcement Administration who certifies that 

25 the requested information is necessary for re-
33 

•S 518 RS 

1 search to be conducted by such department, pro2 gram, or administration, respectively, and the 

3 intended purpose of the research is related to a 

4 function committed to such department, pro5 gram, or administration by law that is not in6 vestigative in nature; or 

7 ‘‘(E) an agent of the State agency or entity 

8 of another State that is responsible for the estab9 lishment and maintenance of that State’s con10 trolled substance monitoring program, who cer11 tifies that— 

12 ‘‘(i) the State has an application ap13 proved under this section; and 

14 ‘‘(ii) the requested information is for 

15 the purpose of implementing the State’s 

16 controlled substance monitoring program 

17 under this section. 

18 ‘‘(2) DRUG DIVERSION.—In consultation with 

19 practitioners, dispensers, and other relevant and in20 terested stakeholders, a State receiving a grant under 

21 subsection (a)— 

22 ‘‘(A) shall establish a program to notify 

23 practitioners and dispensers of information that 

24 will help identify and prevent the unlawful di25 version or misuse of controlled substances; and 
34 

•S 518 RS 

1 ‘‘(B) may, to the extent permitted under 

2 State law, notify the appropriate authorities re3 sponsible for carrying out drug diversion inves4 tigations if the State determines that informa5 tion in the database maintained by the State 

6 under subsection (e) indicates an unlawful diver7 sion or abuse of a controlled substance. 

8 ‘‘(g) LIMITATIONS.—In implementing or improving a 

9 controlled substance monitoring program under this section, 

10 a State— 

11 ‘‘(1) shall limit the information provided pursu12 ant to a valid request under subsection (f)(1) to the 

13 minimum necessary to accomplish the intended pur14 pose of the request; and 

15 ‘‘(2) shall limit information provided in response 

16 to a request under subsection (f)(1)(D) to nonidentifi17 able information. 

18 ‘‘(h) ELECTRONIC FORMAT.—The Secretary shall 

19 specify a uniform electronic format for the reporting, shar20 ing, and disclosure of information under this section. 

21 ‘‘(i) RULES OF CONSTRUCTION.— 

22 ‘‘(1) FUNCTIONS OTHERWISE AUTHORIZED BY

23 LAW.—Nothing in this section shall be construed to 

24 restrict the ability of any authority, including any 

25 local, State, or Federal law enforcement, narcotics 
35 

•S 518 RS 

1 control, licensure, disciplinary, or program authority, 

2 to perform functions otherwise authorized by law. 

3 ‘‘(2) NO PREEMPTION.—Nothing in this section 

4 shall be construed as preempting any State law, ex5 cept that no such law may relieve any person of a re6 quirement otherwise applicable under this Act. 

7 ‘‘(3) ADDITIONAL PRIVACY PROTECTIONS.—Noth8 ing in this section shall be construed as preempting 

9 any State from imposing any additional privacy pro10 tections. 

11 ‘‘(4) CERTAIN CONFIDENTIALITY REQUIRE12 MENTS.—Nothing in this section shall be construed as 

13 preempting the confidentiality requirements of part 2 

14 and part 2a of title 42, Code of Federal Regulations. 

15 ‘‘(5) NO FEDERAL PRIVATE CAUSE OF ACTION.— 

16 Nothing in this section shall be construed to create a 

17 Federal private cause of action. 

18 ‘‘(j) STUDIES AND REPORTS.— 

19 ‘‘(1) IMPLEMENTATION REPORT.— 

20 ‘‘(A) IN GENERAL.—Not later than 180 

21 days after the date of enactment of this section, 

22 the Secretary, based on a review of existing State 

23 controlled substance monitoring programs and 

24 other relevant information, shall determine 
36 

•S 518 RS 

1 whether the implementation of such programs 

2 has had a substantial negative impact on— 

3 ‘‘(i) patient access to treatment, in4 cluding therapy for pain or controlled sub5 stance abuse; 

6 ‘‘(ii) pediatric patient access to treat7 ment; or 

8 ‘‘(iii) patient enrollment in research or 

9 clinical trials in which, following the pro10 tocol that has been approved by the relevant 

11 institutional review board for the research 

12 or clinical trial, the patient has obtained a 

13 controlled substance from either the sci14 entific investigator conducting such research 

15 or clinical trial or the agent thereof. 

16 ‘‘(B) ADDITIONAL CATEGORIES OF EXCLU17 SION.—If the Secretary determines under sub18 paragraph (A) that a substantial negative im19 pact has been demonstrated with regard to one 

20 or more of the categories of patients described in 

21 such subparagraph, the Secretary shall identify 

22 additional appropriate categories of exclusion 

23 from reporting as authorized under subsection 

24 (d)(2)(C). 
37 

•S 518 RS 

1 ‘‘(2) PROGRESS REPORT.—Not later than 3 years 

2 after the date on which funds are first appropriated 

3 under this section, the Secretary shall— 

4 ‘‘(A) complete a study that— 

5 ‘‘(i) determines the progress of States 

6 in establishing and implementing controlled 

7 substance monitoring programs under this 

8 section; 

9 ‘‘(ii) determines the progress of States 

10 in achieving interoperability between con11 trolled substance monitoring programs, in12 cluding an assessment of technical and legal 

13 barriers to such activities and recommenda14 tions for addressing these barriers; 

15 ‘‘(iii) determines the feasibility of im16 plementing a real-time electronic controlled 

17 substance monitoring program, including 

18 the costs associated with establishing such a 

19 program; 

20 ‘‘(iv) provides an analysis of the pri21 vacy protections in place for the informa22 tion reported to the controlled substance 

23 monitoring program in each State receiving 

24 a grant for the establishment or operation of 

25 such program, and any recommendations 
38 

•S 518 RS 

1 for additional requirements for protection of 

2 this information; 

3 ‘‘(v) determines the feasibility of imple4 menting technological alternatives to cen5 tralized data storage, such as peer-to-peer 

6 file sharing or data pointer systems, in con7 trolled substance monitoring programs and 

8 the potential for such alternatives to en9 hance the privacy and security of individ10 ually identifiable data; and 

11 ‘‘(vi) evaluates the penalties that 

12 States have enacted for the unauthorized use 

13 and disclosure of information maintained 

14 in the controlled substance monitoring pro15 gram, and reports on the criteria used by 

16 the Secretary to determine whether such 

17 penalties qualify as appropriate pursuant 

18 to this section; and 

19 ‘‘(B) submit a report to the Congress on the 

20 results of the study. 

21 ‘‘(k) ADVISORY COUNCIL.— 

22 ‘‘(1) ESTABLISHMENT.—A State may establish 

23 an advisory council to assist in the establishment, im24 plementation, or improvement of a controlled sub25 stance monitoring program under this section. 
39 

•S 518 RS 

1 ‘‘(2) LIMITATION.—A State may not use 

2 amounts received under a grant under this section for 

3 the operations of an advisory council established 

4 under paragraph (1). 

5 ‘‘(3) SENSE OF CONGRESS.—It is the sense of the 

6 Congress that, in establishing an advisory council 

7 under this subsection, a State should consult with ap8 propriate professional boards and other interested 

9 parties. 

10 ‘‘(l) DEFINITIONS.—For purposes of this section: 

11 ‘‘(1) The term ‘bona fide patient’ means an indi12 vidual who is a patient of the dispenser or practi13 tioner involved. 

14 ‘‘(2) The term ‘controlled substance’ means a 

15 drug that is included in schedule II, III, or IV of sec16 tion 202(c) of the Controlled Substance Act. 

17 ‘‘(3) The term ‘dispense’ means to deliver a con18 trolled substance to an ultimate user by, or pursuant 

19 to the lawful order of, a practitioner, irrespective of 

20 whether the dispenser uses the Internet or other means 

21 to effect such delivery. 

22 ‘‘(4) The term ‘dispenser’ means a physician, 

23 pharmacist, or other person that dispenses a con24 trolled substance to an ultimate user. 
40 

•S 518 RS 

1 ‘‘(5) The term ‘interoperability’ with respect to a 

2 State controlled substance monitoring program means 

3 the ability of the program to electronically share re4 ported information, including each of the required re5 port components described in subsection (d), with an6 other State if the information concerns either the dis7 pensing of a controlled substance to an ultimate user 

8 who resides in such other State, or the dispensing of 

9 a controlled substance prescribed by a practitioner 

10 whose principal place of business is located in such 

11 other State. 

12 ‘‘(6) The term ‘nonidentifiable information’ 

13 means information that does not identify a practi14 tioner or an ultimate user and with respect to which 

15 there is no reasonable basis to believe that the infor16 mation can be used to identify a practitioner or an 

17 ultimate user. 

18 ‘‘(7) The term ‘practitioner’ means a physician, 

19 dentist, veterinarian, scientific investigator, phar20 macy, hospital, or other person licensed, registered, or 

21 otherwise permitted, by the United States or the juris22 diction in which he or she practices or does research, 

23 to distribute, dispense, conduct research with respect 

24 to, administer, or use in teaching or chemical anal-
41 

•S 518 RS 

1 ysis, a controlled substance in the course of profes2 sional practice or research. 

3 ‘‘(8) The term ‘State’ means each of the 50 

4 States and the District of Columbia. 

5 ‘‘(9) The term ‘ultimate user’ means a person 

6 who has obtained from a dispenser, and who pos7 sesses, a controlled substance for his or her own use, 

8 for the use of a member of his or her household, or 

9 for the use of an animal owned by him or her or by 

10 a member of his or her household. 

11 ‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—To 

12 carry out this section, there are authorized to be appro13 priated— 

14 ‘‘(1) $15,000,000 for each of fiscal years 2006 

15 and 2007; and 

16 ‘‘(2) $10,000,000 for each of fiscal years 2008, 

17 2009, and 2010.’’. 
Calendar No. 187 

109TH CONGRESS 

1ST SESSION S. 518 

[Report No. 109–117] 

A BILL 

To provide for the establishment of a controlled 

substance monitoring program in each State. 

JULY 29, 2005 

Reported with an amendment