I 

108TH CONGRESS 

1ST SESSION H. R. 3015

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 

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 2003’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 
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1 (1) The Harold Rogers Prescription Monitoring 

2 Program has supplied and will continue to supply 

3 critically important information and experience re4 garding effective prescription drug monitoring prac5 tices. 

6 (2) Schedule II, III, and IV controlled sub7 stances have a useful and legitimate medical purpose 

8 and are necessary to maintain the health and gen9 eral welfare of the American people. 

10 (3) Schedule II, III, and IV controlled sub11 stances have a moderate to high potential for misuse 

12 when the prescribing practitioner is unaware of all 

13 such prescriptions that a patient is receiving, includ14 ing abuse, improper use, and illegal distribution. 

15 (4) Such misuse imposes substantial and detri16 mental effects on the health and welfare of the 

17 American people. 

18 (5) Currently there is no national databank 

19 that health care practitioners and pharmacists who, 

20 respectively, prescribe and dispense schedule II, III, 

21 and IV controlled substances can access to deter22 mine whether a particular prescription is medically 

23 unnecessary. 

24 (6) A national electronic databank, supported 

25 by State databanks where they are established under 
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1 State law, would allow providers to access the infor2 mation necessary to ascertain that a particular pre3 scription may be unnecessary or the subject of mis4 use. 

5 (7) A major portion of the use and misuse of 

6 schedule II, III, and IV controlled substances in7 volves interstate and foreign commerce. 

8 (8) Schedule II, III, and IV controlled sub9 stances dispensed intrastate cannot be differentiated 

10 from schedule II, III, and IV controlled substances 

11 that are dispensed interstate, and have significant 

12 interstate effects. 

13 SEC. 3. ELECTRONIC MONITORING SYSTEM FOR DIS14 PENSING CONTROLLED SUBSTANCES. 

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

16 (42 U.S.C. 280g et seq.) is amended by adding after sec17 tion 399N the following: 

18 ‘‘SEC. 399O. ELECTRONIC MONITORING SYSTEM FOR DIS19 PENSING CONTROLLED SUBSTANCES. 

20 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab21 lish an electronic system for practitioner monitoring of the 

22 dispensing of any schedule II, III, or IV controlled sub23 stance involving patients under their care. 
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1 ‘‘(b) NO FEE OR TAX.—A practitioner shall not be 

2 required to pay a fee or tax in connection with the system 

3 established under subsection (a). 

4 ‘‘(c) REPORTING REQUIREMENT.—Every dispenser 

5 shall report to the Secretary the information required by 

6 this section in a timely manner as prescribed by the Sec7 retary, except that reporting shall not be required for—

8 ‘‘(1) a drug administered directly to a patient; 

9 or 

10 ‘‘(2) a drug dispensed in a quantity limited to 

11 an amount adequate to treat the patient for 48 

12 hours or less. 

13 ‘‘(d) INFORMATION TO BE REPORTED.—The Sec14 retary shall determine by regulation the information to be 

15 reported under subsection (a) for each schedule II, III, 

16 or IV controlled substance. Such information shall include 

17 the following: 

18 ‘‘(1) Patient identifier. 

19 ‘‘(2) Drug dispensed. 

20 ‘‘(3) Date of dispensing. 

21 ‘‘(4) Quantity dispensed. 

22 ‘‘(5) Number of refills ordered. 

23 ‘‘(6) Practitioner who signed the prescription. 

24 ‘‘(7) Dispenser. 
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1 ‘‘(e) ELECTRONIC FORMAT.—The Secretary shall 

2 specify the electronic format for the reporting of informa3 tion under subsection (a), and may waive the requirement 

4 of such format with respect to an individual dispenser. 

5 ‘‘(f) PROVISION OF INFORMATION.—The Secretary 

6 may provide information from the system established 

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

8 paragraph (2), compilations of such information, in re9 sponse to a request by—

10 ‘‘(1) a practitioner who certifies that the re11 quested information is for the purpose of providing 

12 medical or pharmaceutical treatment or evaluating 

13 the need for such treatment to a bona fide current 

14 patient; or 

15 ‘‘(2) any local, State, or Federal law enforce16 ment, narcotics control, licensure, disciplinary, or 

17 program authority, who certifies that—

18 ‘‘(A) the requested information is related 

19 to an investigation or proceeding involving the 

20 unlawful diversion or misuse of a schedule II, 

21 III, or IV substance, and the authority has rea22 sonable cause to conclude that such information 

23 will further the purpose of the investigation or 

24 assist in the proceeding; or
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1 ‘‘(B) the requested information is nec2 essary for research purposes, but only in the 

3 case of research to be conducted by the Depart4 ment of Health and Human Services, a State 

5 medicaid program, or the Drug Enforcement 

6 Administration, and the intended purpose of the 

7 research is related to a function committed to 

8 such agency by law that is not investigative in 

9 nature. 

10 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec11 tion shall be construed to restrict the ability of any author12 ity, including any local, State, or Federal law enforcement, 

13 narcotics control, licensure, disciplinary, or program au14 thority, to secure information as otherwise authorized by 

15 law. 

16 ‘‘(h) LIMITATION.—The Secretary shall make reason17 able efforts to limit the information provided pursuant to 

18 a valid request under subsection (f) to the minimum nec19 essary to accomplish the intended purpose of the request. 

20 The Secretary shall also make reasonable efforts to imple21 ment a real-time electronic system, as consistent with any 

22 available appropriated funds. Reports or communications 

23 made under subsections (c), (f)(1), or (f)(2)(A) shall not, 

24 in any event, be made to or by the Secretary more than 

25 1 week after the antecedent or triggering request or event. 
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1 ‘‘(i) SUBSEQUENT TRANSFER OF INFORMATION.—A 

2 person who, pursuant to subsection (f), receives data or 

3 any report of the system from the Secretary shall not pro4 vide the information to any other person or entity except 

5 by order of a court of competent jurisdiction or other legal 

6 authority, by written patient authorization as authorized 

7 under section 164.508(b) of title 45, Code of Federal Reg8 ulations, or any successor regulations, or as otherwise au9 thorized or permitted by the Health Insurance Portability 

10 and Accountability Act of 1996. The provisions of sub11 sections (f), (g), and (h) are deemed to comply with the 

12 Health Insurance Portability and Accountability Act of 

13 1996 and regulations promulgated thereunder. This sec14 tion shall not prevent the disclosure of information by a 

15 local, State, or Federal law enforcement, narcotics control, 

16 licensure, disciplinary, or program authority to district at17 torneys, attorneys general, and others, in furtherance of 

18 criminal investigations or prosecutions, or licensure, dis19 ciplinary, or other judicial or administrative proceedings 

20 within their respective jurisdictions. 

21 ‘‘(j) PENALTIES.—

22 ‘‘(1) Any dispenser who knowingly fails to 

23 transmit information to the Secretary as required by 

24 this section shall be subject to a civil monetary pen25 alty of $100 for each such failure, and a maximum 
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1 civil monetary penalty of $25,000 for such failures 

2 concerning any particular patient. 

3 ‘‘(2) Any person who seeks or makes a knowing 

4 disclosure of transmitted information by or to a per5 son not authorized by subsection (f) or the Health 

6 Insurance Portability and Accountability Act of 

7 1996, or who knowingly obtains information under 

8 this section not relating to a bona fide specific cur9 rent patient, shall be subject to a civil monetary pen10 alty of not more than $25,000 for each such viola11 tion. 

12 ‘‘(k) STATE MONITORING SYSTEM.—A State may 

13 elect to have its own prescription monitoring system, sub14 ject to its own rules and regulations, operating in its juris15 diction to the exclusion of the Federal program created 

16 by this section, so long as the State system provides the 

17 information required by this provision to the Federal pro18 gram in a fashion consistent with any requirements issued 

19 by the Secretary. The Harold Rogers Prescription Moni20 toring Program and the funding it provides may be 

21 accessed by a State electing to proceed under this provi22 sion. This mechanism is intended to encourage States to 

23 develop systems that may operate to provide additional in24 formation and experience that will assist in the refinement 

25 of both the Federal and State programs. 
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1 ‘‘(l) DEFINITIONS.—For purposes of this section: 

2 ‘‘(1) The term ‘administered directly to a pa3 tient’ means the direct application of a schedule II, 

4 III, or IV controlled substance to the body of a pa5 tient by a practitioner or by the practitioner’s agent 

6 in the practitioner’s presence, whether such applica7 tion is by injection, inhalation, ingestion, or any 

8 other means. 

9 ‘‘(2) The term ‘agent’ means an authorized per10 son who acts on behalf of or at the direction of a 

11 practitioner. 

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

13 schedule II, III, or IV controlled substance to an ul14 timate user pursuant to the lawful order of a practi15 tioner. 

16 ‘‘(4) The term ‘dispenser’ means a practitioner 

17 who so delivers a schedule II, III, or IV controlled 

18 substance to an ultimate user. 

19 ‘‘(5) The term ‘local, State, or Federal law en20 forcement, narcotics control, licensure, disciplinary, 

21 or program authority’ means—

22 ‘‘(A) any State or local officer authorized 

23 under State or local law who is employed as an 

24 investigative agent of a State or local narcotics 

25 control agency; 
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1 ‘‘(B) the Drug Enforcement Administra2 tion; 

3 ‘‘(C) the executive director or chief investi4 gator, as designated by each board, of the State 

5 boards of podiatry, dentistry, pharmacy, med6 ical licensure, osteopathic examiners, veterinary 

7 medical examiners, nursing, or other boards 

8 representing appropriate health care-related dis9 ciplines, but only with respect to information 

10 relevant to licensees of the respective boards; 

11 ‘‘(D) the Department of Health and 

12 Human Services; 

13 ‘‘(E) a State medicaid program; 

14 ‘‘(F) a properly convened Federal or State 

15 grand jury or other judicial authority pursuant 

16 to an appropriately and properly issued sub17 poena; or 

18 ‘‘(G) any contractor selected by the Sec19 retary to establish or maintain the prescription 

20 database if the Secretary imposes appropriate 

21 restrictions on such contractor and its per22 sonnel. 

23 ‘‘(6) The term ‘patient identifier’ means the pa24 tient’s—

25 ‘‘(A) full name; 
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1 ‘‘(B) address, including zip code; 

2 ‘‘(C) date of birth; and 

3 ‘‘(D) social security number or alternative 

4 identification number. 

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

6 nurse practitioner, clinical nurse specialist, physician 

7 assistant, dentist, veterinarian, pharmacist, hospital, 

8 or other person licensed, registered, or otherwise 

9 permitted under Federal or State law to distribute, 

10 dispense, or administer a controlled substance in the 

11 course of professional practice. 

12 ‘‘(8) The term ‘schedule II, III, or IV controlled 

13 substance’ means a controlled substance (as that 

14 term is defined in section 102 of the Controlled Sub15 stances Act) included in schedule II, III, or IV of 

16 section 202 of such Act.’’.

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