IB 

Union Calendar No. 448 

108TH CONGRESS 

2D SESSION H. R. 3015 

[Report No. 108–728] 

To amend the Public Health Service Act to establish an electronic system 

for practitioner monitoring of the dispensing of any schedule II, III, 

or IV controlled substance, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 4, 2003 

Mr. WHITFIELD (for himself and Mr. PALLONE) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

OCTOBER 5, 2004 

Additional sponsors: Mrs. NORTHUP, Mr. SESSIONS, Mr. STUPAK, Mrs. 

MALONEY, Mr. KLECZKA, Mr. DICKS, Mr. BROWN of Ohio, Mr. 

PASCRELL, Mr. LUCAS of Kentucky, Mr. GREEN of Texas, Mr. RAMSTAD, 

Mr. JEFFERSON, Mr. WEXLER, Mr. SANDLIN, Mr. NETHERCUTT, Mr. 

VITTER, Mrs. NAPOLITANO, Mr. WELDON of Florida, Mr. KILDEE, Mr. 

SOUDER, Mr. EMANUEL, Mr. BLUNT, Mr. FLETCHER, Ms. DELAURO, 

Mr. DEMINT, Mr. DAVIS of Illinois, Mrs. MUSGRAVE, Mr. BACHUS, Mrs. 

BONO, Mr. EVANS, Mr. SHAYS, Mrs. BIGGERT, Mr. SHIMKUS, Mr. 

BOOZMAN, Mr. PICKERING, Mr. HALL, Mr. PITTS, Ms. SCHAKOWSKY, 

Mrs. JOHNSON of Connecticut, Mr. BASS, Mr. FERGUSON, Mr. GILLMOR, 

Mr. JOHN, Mr. SULLIVAN, Mr. FORBES, Mr. WYNN, Mr. RUSH, Mrs. 

CHRISTENSEN, Mr. DEUTSCH, Mr. ENGEL, Mr. TERRY, Mr. HOEKSTRA, 

Mr. GONZALEZ, Mr. CHANDLER, and Mr. BROWN of South Carolina 

OCTOBER 5, 2004 

Reported with amendments, committed to the Committee of the Whole House 

on the State of the Union, and ordered to be printed 
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[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on September 4, 2003] 

A BILL 

To amend the Public Health Service Act to establish an 

electronic system for practitioner monitoring of the dispensing of any schedule II, III, or IV controlled substance, and for other purposes. 

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 2004’’. 

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 section 

9 399N the following: 

10 ‘‘SEC. 399O. CONTROLLED SUBSTANCE MONITORING PRO11 GRAM. 

12 ‘‘(a) FORMULA GRANTS.— 

13 ‘‘(1) IN GENERAL.—Each fiscal year, the Sec14 retary shall make a payment to each State with an 

15 application approved under this section for the pur16 pose of establishing and implementing a controlled 

17 substance monitoring program under this section. 
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1 ‘‘(2) DETERMINATION OF AMOUNT.—In making 

2 payments under paragraph (1) for a fiscal year, the 

3 Secretary shall allocate to each State with an appli4 cation approved under this section an amount which 

5 bears the same ratio to the amount appropriated to 

6 carry out this section for that fiscal year as the num7 ber of pharmacies of the State bears to the number of 

8 pharmacies of all States with applications approved 

9 under this section (as determined by the Secretary), 

10 except that the Secretary may adjust the amount allo11 cated to a State under this paragraph after taking 

12 into consideration the budget cost estimate for the 

13 State’s controlled substance monitoring program. 

14 ‘‘(b) APPLICATION APPROVAL PROCESS.— 

15 ‘‘(1) IN GENERAL.—To seek a grant under this 

16 section, a State shall submit an application at such 

17 time, in such manner, and containing such assur18 ances and information as the Secretary may reason19 ably require. Each such application shall include— 

20 ‘‘(A) a budget cost estimate for the State’s 

21 controlled substance monitoring program; and 

22 ‘‘(B) assurances of compliance with the re23 quirements of this section. 

24 ‘‘(2) APPROVAL OR DISAPPROVAL.—Not later 

25 than 90 days after the submission by a State of an 
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1 application under paragraph (1), the Secretary shall 

2 approve or disapprove the application. The Secretary 

3 shall approve the application if the State dem4 onstrates to the Secretary that the State will establish 

5 and implement a controlled substance monitoring 

6 program in accordance with this section. 

7 ‘‘(3) WITHDRAWAL OF AUTHORIZATION.—If a 

8 State fails to implement a controlled substance moni9 toring program in accordance with this section— 

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

11 failure to the State; and 

12 ‘‘(B) if the State fails to take corrective ac13 tion within a reasonable period of time, the Sec14 retary shall withdraw any approval of the 

15 State’s application under this section. 

16 ‘‘(4) VOLUNTARY DISCONTINUANCE.—A funding 

17 agreement for the receipt of a payment under this sec18 tion is that the State involved will give a reasonable 

19 period of notice to the Secretary before ceasing to im20 plement a controlled substance monitoring program 

21 under this section. The Secretary shall determine the 

22 period of notice that is reasonable for purposes of this 

23 paragraph. 

24 ‘‘(5) RETURN OF FUNDS.—If the Secretary with25 draws approval of a State’s application under this 
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1 section, or the State chooses to cease to implement a 

2 controlled substance monitoring program under this 

3 section, a funding agreement for the receipt of a pay4 ment under this section is that the State will return 

5 to the Secretary an amount which bears the same 

6 ratio to the overall payment as the remaining time 

7 period for expending the payment bears to the overall 

8 time period for expending the payment (as specified 

9 by the Secretary at the time of the payment). 

10 ‘‘(c) REPORTING REQUIREMENTS.—In implementing a 

11 controlled substance monitoring program under this section, 

12 a State shall comply with the following: 

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

14 to such State each dispensing in the State of a con15 trolled substance to an ultimate user or research sub16 ject not later than 1 week after the date of such dis17 pensing. 

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

19 requirement of this subsection— 

20 ‘‘(A) the direct application of a controlled 

21 substance to the body of an ultimate user or re22 search subject; 

23 ‘‘(B) the dispensing of a controlled sub24 stance in a quantity limited to an amount ade-
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1 quate to treat the ultimate user or research sub2 ject involved for 48 hours or less; or 

3 ‘‘(C) the application or dispensing of a con4 trolled substance in accordance with any other 

5 exclusion identified by the Secretary for purposes 

6 of this paragraph. 

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

8 subsection with respect to the dispensing of a con9 trolled substance shall include the following: 

10 ‘‘(A) Drug Enforcement Administration 

11 Registration Number of the dispenser. 

12 ‘‘(B) Drug Enforcement Administration 

13 Registration Number and name of the practi14 tioner who prescribed the drug. 

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

16 of the ultimate user or research subject. 

17 ‘‘(D) Identification of the drug by a na18 tional drug code number. 

19 ‘‘(E) Quantity dispensed. 

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

21 such quantity should last. 

22 ‘‘(G) Number of refills ordered. 

23 ‘‘(H) Whether the drug was dispensed as a 

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

25 ‘‘(I) Date of the dispensing. 
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1 ‘‘(J) Date of origin of the prescription. 

2 ‘‘(4) The State shall specify an electronic format 

3 for the reporting of information under this subsection 

4 and may waive the requirement of such format with 

5 respect to an individual dispenser. 

6 ‘‘(5) The State shall automatically share infor7 mation reported under this subsection with another 

8 State with an application approved under this sec9 tion if the information concerns— 

10 ‘‘(A) the dispensing of a controlled sub11 stance to an ultimate consumer or research sub12 ject who resides in such other State; or 

13 ‘‘(B) the dispensing of a controlled sub14 stance prescribed by a practitioner whose prin15 cipal place of business is located in such other 

16 State. 

17 ‘‘(6) The State shall notify the appropriate au18 thorities responsible for drug diversion investigation 

19 if information in the database maintained by the 

20 State under subsection (d) indicates a potential un21 lawful diversion or misuse of a controlled substance. 

22 ‘‘(d) DATABASE.—In implementing a controlled sub23 stance monitoring program under this section, a State shall 

24 comply with the following: 
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1 ‘‘(1) The State shall establish and maintain an 

2 electronic database containing the information re3 ported to the State under subsection (c). 

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

5 field or combination of fields. 

6 ‘‘(3) The State shall include reported informa7 tion in the database at such time and in such manner 

8 as the Secretary determines appropriate, with appro9 priate safeguards for ensuring the accuracy and com10 pleteness of the database. 

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

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

13 database. 

14 ‘‘(e) PROVISION OF INFORMATION.—Subject to sub15 section (f), in implementing a controlled substance moni16 toring program under this section, a State may provide in17 formation from the database established under subsection 

18 (d) and, in the case of a request under paragraph (2) or 

19 (3), compilations of such information, in response to a re20 quest by— 

21 ‘‘(1) a practitioner (or the agent thereof) who 

22 certifies that the requested information is for the pur23 pose of providing medical or pharmaceutical treat24 ment or evaluating the need for such treatment to a 

25 bona fide current patient; 
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1 ‘‘(2) any local, State, or Federal law enforce2 ment, narcotics control, licensure, disciplinary, or 

3 program authority, who certifies that the requested 

4 information is related to an individual investigation 

5 or proceeding involving the unlawful diversion or 

6 misuse of a schedule II, III, or IV substance, and such 

7 information will further the purpose of the investiga8 tion or assist in the proceeding; or 

9 ‘‘(3) any agent of the Department of Health and 

10 Human Services, a State medicaid program, a State 

11 health department, or the Drug Enforcement Adminis12 tration who certifies that the requested information is 

13 necessary for research to be conducted by such depart14 ment, program, or administration, respectively, and 

15 the intended purpose of the research is related to a 

16 function committed to such department, program, or 

17 administration by law that is not investigative in na18 ture. 

19 ‘‘(f) LIMITATIONS.—In implementing a controlled sub20 stance monitoring program under this section, a State— 

21 ‘‘(1) shall make reasonable efforts to limit the in22 formation provided pursuant to a valid request under 

23 subsection (e) to the minimum necessary to accom24 plish the intended purpose of the request; and 
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1 ‘‘(2) shall not provide any individually identifi2 able information in response to a request under sub3 section (e)(3). 

4 ‘‘(g) RULES OF CONSTRUCTION.— 

5 ‘‘(1) FUNCTIONS OTHERWISE AUTHORIZED BY

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

7 restrict the ability of any authority, including any 

8 local, State, or Federal law enforcement, narcotics 

9 control, licensure, disciplinary, or program authority, 

10 to perform functions otherwise authorized by law. 

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

12 shall be construed as preempting any State law, ex13 cept that no such law may relieve any person of a re14 quirement otherwise applicable under this Act. 

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

16 Nothing in this section shall be construed to create a 

17 Federal private cause of action. 

18 ‘‘(h) RELATION TO HIPAA.—Except to the extent in19 consistent with this section, the provision of information 

20 pursuant to subsection (c)(5), (c)(6), or (e) and the subse21 quent transfer of such information are subject to any re22 quirement that would otherwise apply under the regulations 

23 promulgated pursuant to section 264(c) of the Health Insur24 ance Portability and Accountability Act of 1996. 
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1 ‘‘(i) PREFERENCE.—The Secretary, in awarding any 

2 competitive grant that is related to drug abuse (as deter3 mined by the Secretary) to a State, shall give preference 

4 to any State with an application approved under this sec5 tion. 

6 ‘‘(j) STUDY.—Not later than 1 year after the date of 

7 the enactment of this section, the Secretary shall— 

8 ‘‘(1) complete a study on— 

9 ‘‘(A) the progress of States in establishing 

10 and implementing controlled substance moni11 toring programs under this section; and 

12 ‘‘(B) the feasibility of implementing a real13 time electronic controlled substance monitoring 

14 program, including the costs associated with es15 tablishing such a program; and 

16 ‘‘(2) submit a report to the Congress on the re17 sults of the study. 

18 ‘‘(k) ADVISORY COUNCIL.— 

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

20 an advisory council to assist in the establishment and 

21 implementation of a controlled substance monitoring 

22 program under this section. 

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

24 Congress that, in establishing an advisory council 

25 under this subsection, a State should consult with 
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1 State boards of pharmacy, State boards of medicine, 

2 and other interested parties. 

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

4 ‘‘(1) The term ‘bona fide patient’ means an indi5 vidual who is a patient of the dispenser or practi6 tioner involved. 

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

8 drug that is— 

9 ‘‘(A) included in schedule II, III, or IV of 

10 section 202(c) of the Controlled Substance Act; or 

11 ‘‘(B) identified by the State involved as a 

12 drug subject to the monitoring program of the 

13 State under this section. 

14 ‘‘(3) The term ‘dispense’ means to deliver a con15 trolled substance to an ultimate user or research sub16 ject by, or pursuant to the lawful order of, a practi17 tioner, irrespective of whether the dispenser uses the 

18 Internet or other means to effect such delivery. 

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

20 pharmacist, or other individual who dispenses a con21 trolled substance to an ultimate user or research sub22 ject. 

23 ‘‘(5) The term ‘practitioner’ means a physician, 

24 dentist, veterinarian, scientific investigator, phar25 macy, hospital, or other person licensed, registered, or 
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1 otherwise permitted, by the United States or the juris2 diction in which he or she practices or does research, 

3 to distribute, dispense, conduct research with respect 

4 to, administer, or use in teaching or chemical anal5 ysis, a controlled substance in the course of profes6 sional practice or research. 

7 ‘‘(6) The term ‘State’ means each of the 50 

8 States and the District of Columbia. 

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

10 who has lawfully obtained, and who possesses, a con11 trolled substance for his or her own use, for the use 

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

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

14 of his or her household. 

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

16 carry out this section, there are authorized to be appro17 priated— 

18 ‘‘(1) $25,000,000 for each of fiscal years 2006 

19 and 2007; and 

20 ‘‘(2) $15,000,000 for each of fiscal years 2008, 

21 2009, and 2010.’’. 

Amend the title so as to read: ‘‘A bill to provide for 

the establishment of a controlled substance monitoring 

program in each State.’’. 
Union Calendar No. 448 

108TH CONGRESS 

2D SESSION H. R. 3015 

[Report No. 108–728] 

A BILL 

To amend the Public Health Service Act to estabposes. or IV controlled substance, and for other pur- toring of the dispensing of any schedule II, III, lish an electronic system for practitioner moniOCTOBER 5, 2004 

Reported with amendments, committed to the Committee 

dered to be printed of the Whole House on the State of the Union, and or-