II 

109TH CONGRESS 

1ST SESSION S. 518

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, and Mr. DODD) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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’’. 

6 SEC. 2. CONTROLLED SUBSTANCE MONITORING PROGRAM. 

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

8 (42 U.S.C. 280g et seq.) is amended by adding after sec9 tion 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 

15 a fiscal year, the Secretary shall allocate to 

16 each State with an application approved under 

17 this section an amount that equals 0.5 percent 

18 of the amount appropriated to carry out this 

19 section 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 
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1 remaining after amounts are made available 

2 under paragraph (1) as the number of phar3 macies of the State bears to the number of 

4 pharmacies of all States with applications ap5 proved under this section (as determined by the 

6 Secretary), except that the Secretary may ad7 just the amount allocated to a State under this 

8 subparagraph after taking into consideration 

9 the budget cost estimate for the State’s con10 trolled substance monitoring program. 

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

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

13 months. 

14 ‘‘(b) DEVELOPMENT OF MINIMUM STANDARDS AND

15 RECOMMENDATIONS.—

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

17 after the date of enactment of this section, the Sec18 retary shall—

19 ‘‘(A) develop minimum standards for use 

20 by States in submitting their proposed stand21 ards under clauses (ii), (v), (vi), and (vii) of 

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

23 ‘‘(B) develop recommendations with re24 spect to appropriate penalties for the provision 
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1 or use of information in violation of applicable 

2 Federal, State, or local law or regulation. 

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

4 date of enactment of this section, the Secretary shall 

5 report to Congress on the recommendations devel6 oped under paragraph (1)(B) and the extent to 

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

8 such recommendations. 

9 ‘‘(c) APPLICATION APPROVAL PROCESS.—

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

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

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

13 application to the Secretary at such time, in such 

14 manner, and containing such assurances and infor15 mation as the Secretary may reasonably require. 

16 Each such application shall include—

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

18 to use funds under the grant as provided for in 

19 subsection (a)(1)(A)—

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

21 controlled substance monitoring program 

22 to be implemented under the grant; 

23 ‘‘(ii) proposed standards for security 

24 for information handling and for the data25 base maintained by the State under sub-
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1 section (e) generally including efforts to 

2 use appropriate encryption technology or 

3 other appropriate technology to protect the 

4 security of such information; 

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

6 extent practicable, applicable health infor7 mation technology standards, as deter8 mined by the Secretary; 

9 ‘‘(iv) proposed standards for meeting 

10 the uniform electronic format requirement 

11 of subsection (h); 

12 ‘‘(v) proposed standards for avail13 ability of information and limitation on ac14 cess to program personnel; 

15 ‘‘(vi) proposed standards for access to 

16 the database, and procedures to ensure 

17 database accuracy; 

18 ‘‘(vii) proposed standards for the pro19 vision of information, including a descrip20 tion of the certification process to be ap21 plied to requests for information under 

22 subsection (f); 

23 ‘‘(viii) proposed penalties for the pro24 vision or use of information in violation of
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1 applicable Federal, State, or local law or 

2 regulation; and

3 ‘‘(ix) assurances of compliance with 

4 all other requirements of this section; or 

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

6 to use funds under the grant as provided for in 

7 subsection (a)(1)(B)—

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

9 controlled substance monitoring program 

10 to be improved under the grant; 

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

12 State controlled substance monitoring pro13 gram is in compliance with the standards 

14 and penalty requirements described in 

15 clauses (ii) through (viii) of subparagraph 

16 (A); 

17 ‘‘(iii) a plan to enable the State con18 trolled substance monitoring program to 

19 achieve interoperability with at least one 

20 other State controlled substance moni21 toring program, including—

22 ‘‘(I) the technical achievement of 

23 information sharing between the two 

24 programs; 
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1 ‘‘(II) measures to ensure that 

2 interoperability activities carried out 

3 under this subsection are in compli4 ance with the requirements of sub5 paragraph (A); 

6 ‘‘(III) measures to ensure that 

7 proposed standards for information 

8 access will be enforced for shared in9 formation; and 

10 ‘‘(IV) the completion of interstate 

11 legal compacts necessary for such in12 formation sharing; and 

13 ‘‘(iv) assurances of compliance with 

14 all other requirements of this section or a 

15 statement describing why such compliance 

16 is not feasible or is contrary to the best in17 terests of public health in such State. 

18 ‘‘(2) APPROVAL OR DISAPPROVAL.—

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

20 days after the submission by a State of an ap21 plication under paragraph (1), the Secretary 

22 shall approve or disapprove the application, or 

23 request additional information as provided 

24 under subparagraph (C). The Secretary may 

25 disapprove an application that contains a state-
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1 ment described in paragraph (1)(B)(iv), or re2 quest additional information with respect to 

3 such a statement, if the Secretary determines 

4 that the approval of such application would re5 sult in the implementation of a State program 

6 that substantially fails to meet the goals and 

7 objectives of this section. 

8 ‘‘(B) APPROVAL.—The Secretary shall ap9 prove an application submitted under para10 graph (1) only if—

11 ‘‘(i) the plans contained in the appli12 cation meet the standards developed by the 

13 Secretary under subsection (b); and 

14 ‘‘(ii) the State demonstrates to the 

15 Secretary that the State will establish and 

16 implement or improve a controlled sub17 stance monitoring program in accordance 

18 with this section. 

19 ‘‘(C) ADDITIONAL INFORMATION.—With 

20 respect to an application submitted by a State 

21 under paragraph (1), the Secretary may, during 

22 the 90-day period referred to in subparagraph 

23 (A), request that the State provide additional 

24 information with respect to the State program. 

25 If such a request is made after the expiration 
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1 of the 60-day period beginning on the date on 

2 which the application is submitted, the period 

3 under subparagraph (A) for approval or dis4 approval by the Secretary shall be extended for 

5 an additional 30 days. 

6 ‘‘(3) WITHDRAWAL OF AUTHORIZATION.—Ex7 cept to the extent that a State is excused from com8 pliance with a requirement or standard as a result 

9 of the approval by the Secretary of a statement 

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

11 if a State fails to implement or improve a controlled 

12 substance monitoring program in accordance with 

13 this section or fails to comply with the standards de14 veloped under this subsection—

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

16 failure to the State; and 

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

18 action within a reasonable period of time, the 

19 Secretary shall withdraw any approval of the 

20 State’s application under this section. 

21 ‘‘(4) VOLUNTARY DISCONTINUANCE.—A fund22 ing agreement for the receipt of a grant under this 

23 section is that the State involved will give a reason24 able period of notice to the Secretary before ceasing 

25 to implement or operate a controlled substance mon-
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1 itoring program under this section. The Secretary 

2 shall determine the period of notice that is reason3 able for purposes of this paragraph. 

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

5 withdraws approval of a State’s application under 

6 this section, or the State chooses to cease to imple7 ment or improve a controlled substance monitoring 

8 program under this section, a funding agreement for 

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

10 State will return to the Secretary an amount which 

11 bears the same ratio to the overall grant as the re12 maining time period for expending the grant funds 

13 bears to the overall time period for expending the 

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

15 the grant). 

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

17 or improving a controlled substance monitoring program 

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

19 to a State that applies for a grant under subsection 

20 (a)(1)(B) submit to the Secretary for approval a state21 ment of why such compliance is not feasible or is contrary 

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

23 the following: 

24 ‘‘(1) The State shall require dispensers to re25 port to such State each dispensing in the State of
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1 a controlled substance to an ultimate user not later 

2 than 1 week after the date of such dispensing.

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

4 requirement of this subsection—

5 ‘‘(A) the direct administration of a con6 trolled substance to the body of an ultimate 

7 user; 

8 ‘‘(B) the dispensing of a controlled sub9 stance in a quantity limited to an amount ade10 quate to treat the ultimate user involved for 48 

11 hours or less; or 

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

13 controlled substance in accordance with any 

14 other exclusion identified by the Secretary for 

15 purposes of this paragraph. 

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

17 subsection with respect to the dispensing of a con18 trolled substance shall include the following: 

19 ‘‘(A) Drug Enforcement Administration 

20 Registration Number of the dispenser. 

21 ‘‘(B) Drug Enforcement Administration 

22 Registration Number and name of the practi23 tioner who prescribed the drug. 

24 ‘‘(C) Name, address, and telephone num25 ber of the ultimate user or such contact infor-
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1 mation of the ultimate user as the Secretary de2 termines appropriate. 

3 ‘‘(D) Identification of the drug by a na4 tional drug code number. 

5 ‘‘(E) Quantity dispensed. 

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

7 such quantity should last. 

8 ‘‘(G) Number of refills ordered. 

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

10 a refill of a prescription or as a first-time re11 quest. 

12 ‘‘(I) Date of the dispensing. 

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

14 ‘‘(4) The State shall require dispensers to re15 port information under this section in accordance 

16 with the electronic format specified by the Secretary 

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

18 waive the requirement of such format with respect to 

19 an individual dispenser. 

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

21 controlled substance monitoring program under this sec22 tion, a State shall comply with the following: 

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

24 electronic database containing the information re25 ported to the State under subsection (d). 
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1 ‘‘(2) The database must be searchable by any 

2 field or combination of fields. 

3 ‘‘(3) The State shall include reported informa4 tion in the database in a manner consistent with 

5 standards established by the Secretary, with appro6 priate safeguards for ensuring the accuracy and 

7 completeness of the database. 

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

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

10 the database. 

11 ‘‘(f) PROVISION OF INFORMATION.—

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

13 in implementing or improving a controlled substance 

14 monitoring program under this section, a State may 

15 provide information from the database established 

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

17 under paragraph (3), summary statistics of such in18 formation, in response to a request by—

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

20 who certifies, under the procedures determined 

21 by the State, that the requested information is 

22 for the purpose of providing medical or pharma23 ceutical treatment or evaluating the need for 

24 such treatment to a bona fide current patient; 
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1 ‘‘(B) any local, State, or Federal law en2 forcement, narcotics control, licensure, discipli3 nary, or program authority, who certifies, under 

4 the procedures determined by the State, that 

5 the requested information is related to an indi6 vidual investigation or proceeding involving the 

7 unlawful diversion or misuse of a schedule II, 

8 III, or IV substance, and such information will 

9 further the purpose of the investigation or as10 sist in the proceeding; 

11 ‘‘(C) the controlled substance monitoring 

12 program of another State or group of States 

13 with whom the State has established an inter14 operability agreement; 

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

16 Health and Human Services, a State medicaid 

17 program, a State health department, or the 

18 Drug Enforcement Administration who certifies 

19 that the requested information is necessary for 

20 research to be conducted by such department, 

21 program, or administration, respectively, and 

22 the intended purpose of the research is related 

23 to a function committed to such department, 

24 program, or administration by law that is not 

25 investigative in nature; or 
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1 ‘‘(E) an agent of the State agency or enti2 ty of another State that is responsible for the 

3 establishment and maintenance of that State’s 

4 controlled substance monitoring program, who 

5 certifies that—

6 ‘‘(i) the State has an application ap7 proved under this section; and 

8 ‘‘(ii) the requested information is for 

9 the purpose of implementing the State’s 

10 controlled substance monitoring program 

11 under this section. 

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

13 exercise its authority to notify the appropriate au14 thorities responsible for drug diversion investigations 

15 if information in the database maintained by the 

16 State under subsection (e) is suggestive of an unlaw17 ful diversion or misuse of a controlled substance, is 

18 encouraged to develop any such notification program 

19 in consultation with representatives of the medical 

20 community, including physicians and pharmacists or 

21 other interested stakeholders. 

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

23 controlled substance monitoring program under this sec24 tion, a State—
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1 ‘‘(1) shall make reasonable efforts to limit the 

2 information provided pursuant to a valid request 

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

4 accomplish the intended purpose of the request; and 

5 ‘‘(2) shall limit information provided in re6 sponse to a request under subsection (f)(1)(D) to in7 formation provided in a form and manner that pre8 vents the identification of a provider or patient. 

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

10 specify a uniform electronic format for the reporting, shar11 ing, and provision of information under this section. 

12 ‘‘(i) RULES OF CONSTRUCTION.—

13 ‘‘(1) FUNCTIONS OTHERWISE AUTHORIZED BY

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

15 restrict the ability of any authority, including any 

16 local, State, or Federal law enforcement, narcotics 

17 control, licensure, disciplinary, or program authority, 

18 to perform functions otherwise authorized by law. 

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

20 shall be construed as preempting any State law, ex21 cept that no such law may relieve any person of a 

22 requirement otherwise applicable under this Act. 

23 ‘‘(3) ADDITIONAL PRIVACY PROTECTIONS.—

24 Nothing in this section shall be construed as pre-
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1 empting any State from imposing any additional pri2 vacy protections. 

3 ‘‘(4) CERTAIN CONFIDENTIALITY REQUIRE4 MENTS.—Nothing in this section shall be construed 

5 as superseding the confidentiality requirements of 

6 programs defined by and subject to part 2 of title 

7 42, Code of Federal Regulations. 

8 ‘‘(5) NO FEDERAL PRIVATE CAUSE OF AC9 TION.—Nothing in this section shall be construed to 

10 create a Federal private cause of action. 

11 ‘‘(j) RELATION TO HIPAA.—Except to the extent in12 consistent with this section, the provision of information 

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

14 such information are subject to any requirement that 

15 would otherwise apply under the regulations promulgated 

16 pursuant to section 264(c) of the Health Insurance Port17 ability and Accountability Act of 1996. 

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

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

20 ‘‘(1) complete a study that—

21 ‘‘(A) determines the progress of States in 

22 establishing and implementing controlled sub23 stance monitoring programs under this section; 

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

25 achieving interoperability between controlled 
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1 substance monitoring programs, including an 

2 assessment of technical and legal barriers to 

3 such activities and recommendations for ad4 dressing these barriers; 

5 ‘‘(C) determines the feasibility of imple6 menting a real-time electronic controlled sub7 stance monitoring program, including the costs 

8 associated with establishing such a program; 

9 and 

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

11 protections in place for the information re12 ported to the controlled substance monitoring 

13 program in each State receiving a grant for the 

14 establishment or operation of such program, 

15 and a comparison to the privacy requirements 

16 that apply to covered entities under regulations 

17 promulgated pursuant to section 264(c) of the 

18 Health Insurance Portability and Accountability 

19 Act of 1996, along with any recommendations 

20 for additional requirements for protection of 

21 this information; and 

22 ‘‘(E) determines the feasibility of imple23 menting technological alternatives to centralized 

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

25 or data pointer systems, in controlled substance 
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1 monitoring programs and the potential for such 

2 alternatives to enhance the privacy and security 

3 of individually identifiable data; and 

4 ‘‘(2) submit a report to the Congress on the re5 sults of the study. 

6 ‘‘(l) ADVISORY COUNCIL.—

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

8 an advisory council to assist in the establishment, 

9 implementation, or improvement of a controlled sub10 stance monitoring program under this section. 

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

12 the Congress that, in establishing an advisory coun13 cil under this subsection, a State should consult with 

14 appropriate professional boards and other interested 

15 parties. 

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

17 ‘‘(1) The term ‘bona fide patient’ means an in18 dividual who is a patient of the dispenser or practi19 tioner involved. 

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

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

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

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

24 controlled substance to an ultimate user by, or pur25 suant to the lawful order of, a practitioner, irrespec-
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1 tive of whether the dispenser uses the Internet or 

2 other means to effect such delivery. 

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

4 pharmacist, or other individual who dispenses a con5 trolled substance to an ultimate user. 

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

7 a State controlled substance monitoring program 

8 means the ability of the program to electronically 

9 share reported information, including each of the re10 quired report components described in subsection 

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

12 either the dispensing of a controlled substance to an 

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

14 dispensing of a controlled substance prescribed by a 

15 practitioner whose principal place of business is lo16 cated in such other State. 

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

18 means information that is provided in a form and 

19 manner that prevents the identification of a provider 

20 or patient. 

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

22 dentist, veterinarian, scientific investigator, phar23 macy, hospital, or other person licensed, registered, 

24 or otherwise permitted, by the United States or the 

25 jurisdiction in which he or she practices or does re-
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1 search, to distribute, dispense, conduct research with 

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

3 analysis, a controlled substance in the course of pro4 fessional practice or research. 

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

6 States and the District of Columbia. 

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

8 who has lawfully obtained, and who possesses, a con9 trolled substance for his or her own use, for the use 

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

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

12 of his or her household. 

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

14 carry out this section, there are authorized to be appro15 priated—

16 ‘‘(1) $25,000,000 for each of fiscal years 2006 

17 and 2007; and 

18 ‘‘(2) $15,000,000 for each of fiscal years 2008, 

19 2009, and 2010.’’.

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