[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3015 Introduced in House (IH)]







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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National All Schedules Prescription 
Electronic Reporting Act of 2003''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) The Harold Rogers Prescription Monitoring Program has 
        supplied and will continue to supply critically important 
        information and experience regarding effective prescription 
        drug monitoring practices.
            (2) Schedule II, III, and IV controlled substances have a 
        useful and legitimate medical purpose and are necessary to 
        maintain the health and general welfare of the American people.
            (3) Schedule II, III, and IV controlled substances have a 
        moderate to high potential for misuse when the prescribing 
        practitioner is unaware of all such prescriptions that a 
        patient is receiving, including abuse, improper use, and 
        illegal distribution.
            (4) Such misuse imposes substantial and detrimental effects 
        on the health and welfare of the American people.
            (5) Currently there is no national databank that health 
        care practitioners and pharmacists who, respectively, prescribe 
        and dispense schedule II, III, and IV controlled substances can 
        access to determine whether a particular prescription is 
        medically unnecessary.
            (6) A national electronic databank, supported by State 
        databanks where they are established under State law, would 
        allow providers to access the information necessary to 
        ascertain that a particular prescription may be unnecessary or 
        the subject of misuse.
            (7) A major portion of the use and misuse of schedule II, 
        III, and IV controlled substances involves interstate and 
        foreign commerce.
            (8) Schedule II, III, and IV controlled substances 
        dispensed intrastate cannot be differentiated from schedule II, 
        III, and IV controlled substances that are dispensed 
        interstate, and have significant interstate effects.

SEC. 3. ELECTRONIC MONITORING SYSTEM FOR DISPENSING CONTROLLED 
              SUBSTANCES.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding after section 399N the following:

``SEC. 399O. ELECTRONIC MONITORING SYSTEM FOR DISPENSING CONTROLLED 
              SUBSTANCES.

    ``(a) Establishment.--The Secretary shall establish an electronic 
system for practitioner monitoring of the dispensing of any schedule 
II, III, or IV controlled substance involving patients under their 
care.
    ``(b) No Fee or Tax.--A practitioner shall not be required to pay a 
fee or tax in connection with the system established under subsection 
(a).
    ``(c) Reporting Requirement.--Every dispenser shall report to the 
Secretary the information required by this section in a timely manner 
as prescribed by the Secretary, except that reporting shall not be 
required for--
            ``(1) a drug administered directly to a patient; or
            ``(2) a drug dispensed in a quantity limited to an amount 
        adequate to treat the patient for 48 hours or less.
    ``(d) Information To Be Reported.--The Secretary shall determine by 
regulation the information to be reported under subsection (a) for each 
schedule II, III, or IV controlled substance. Such information shall 
include the following:
            ``(1) Patient identifier.
            ``(2) Drug dispensed.
            ``(3) Date of dispensing.
            ``(4) Quantity dispensed.
            ``(5) Number of refills ordered.
            ``(6) Practitioner who signed the prescription.
            ``(7) Dispenser.
    ``(e) Electronic Format.--The Secretary shall specify the 
electronic format for the reporting of information under subsection 
(a), and may waive the requirement of such format with respect to an 
individual dispenser.
    ``(f) Provision of Information.--The Secretary may provide 
information from the system established under subsection (a) and, in 
the case of a request under paragraph (2), compilations of such 
information, in response to a request by--
            ``(1) a practitioner who certifies that the requested 
        information is for the purpose of providing medical or 
        pharmaceutical treatment or evaluating the need for such 
        treatment to a bona fide current patient; or
            ``(2) any local, State, or Federal law enforcement, 
        narcotics control, licensure, disciplinary, or program 
        authority, who certifies that--
                    ``(A) the requested information is related to an 
                investigation or proceeding involving the unlawful 
                diversion or misuse of a schedule II, III, or IV 
                substance, and the authority has reasonable cause to 
                conclude that such information will further the purpose 
                of the investigation or assist in the proceeding; or
                    ``(B) the requested information is necessary for 
                research purposes, but only in the case of research to 
                be conducted by the Department of Health and Human 
                Services, a State medicaid program, or the Drug 
                Enforcement Administration, and the intended purpose of 
                the research is related to a function committed to such 
                agency by law that is not investigative in nature.
    ``(g) Rule of Construction.--Nothing in this section shall be 
construed to restrict the ability of any authority, including any 
local, State, or Federal law enforcement, narcotics control, licensure, 
disciplinary, or program authority, to secure information as otherwise 
authorized by law.
    ``(h) Limitation.--The Secretary shall make reasonable efforts to 
limit the information provided pursuant to a valid request under 
subsection (f) to the minimum necessary to accomplish the intended 
purpose of the request. The Secretary shall also make reasonable 
efforts to implement a real-time electronic system, as consistent with 
any available appropriated funds. Reports or communications made under 
subsections (c), (f)(1), or (f)(2)(A) shall not, in any event, be made 
to or by the Secretary more than 1 week after the antecedent or 
triggering request or event.
    ``(i) Subsequent Transfer of Information.--A person who, pursuant 
to subsection (f), receives data or any report of the system from the 
Secretary shall not provide the information to any other person or 
entity except by order of a court of competent jurisdiction or other 
legal authority, by written patient authorization as authorized under 
section 164.508(b) of title 45, Code of Federal Regulations, or any 
successor regulations, or as otherwise authorized or permitted by the 
Health Insurance Portability and Accountability Act of 1996. The 
provisions of subsections (f), (g), and (h) are deemed to comply with 
the Health Insurance Portability and Accountability Act of 1996 and 
regulations promulgated thereunder. This section shall not prevent the 
disclosure of information by a local, State, or Federal law 
enforcement, narcotics control, licensure, disciplinary, or program 
authority to district attorneys, attorneys general, and others, in 
furtherance of criminal investigations or prosecutions, or licensure, 
disciplinary, or other judicial or administrative proceedings within 
their respective jurisdictions.
    ``(j) Penalties.--
            ``(1) Any dispenser who knowingly fails to transmit 
        information to the Secretary as required by this section shall 
        be subject to a civil monetary penalty of $100 for each such 
        failure, and a maximum civil monetary penalty of $25,000 for 
        such failures concerning any particular patient.
            ``(2) Any person who seeks or makes a knowing disclosure of 
        transmitted information by or to a person not authorized by 
        subsection (f) or the Health Insurance Portability and 
        Accountability Act of 1996, or who knowingly obtains 
        information under this section not relating to a bona fide 
        specific current patient, shall be subject to a civil monetary 
        penalty of not more than $25,000 for each such violation.
    ``(k) State Monitoring System.--A State may elect to have its own 
prescription monitoring system, subject to its own rules and 
regulations, operating in its jurisdiction to the exclusion of the 
Federal program created by this section, so long as the State system 
provides the information required by this provision to the Federal 
program in a fashion consistent with any requirements issued by the 
Secretary. The Harold Rogers Prescription Monitoring Program and the 
funding it provides may be accessed by a State electing to proceed 
under this provision. This mechanism is intended to encourage States to 
develop systems that may operate to provide additional information and 
experience that will assist in the refinement of both the Federal and 
State programs.
    ``(l) Definitions.--For purposes of this section:
            ``(1) The term `administered directly to a patient' means 
        the direct application of a schedule II, III, or IV controlled 
        substance to the body of a patient by a practitioner or by the 
        practitioner's agent in the practitioner's presence, whether 
        such application is by injection, inhalation, ingestion, or any 
        other means.
            ``(2) The term `agent' means an authorized person who acts 
        on behalf of or at the direction of a practitioner.
            ``(3) The term `dispense' means to deliver a schedule II, 
        III, or IV controlled substance to an ultimate user pursuant to 
        the lawful order of a practitioner.
            ``(4) The term `dispenser' means a practitioner who so 
        delivers a schedule II, III, or IV controlled substance to an 
        ultimate user.
            ``(5) The term `local, State, or Federal law enforcement, 
        narcotics control, licensure, disciplinary, or program 
        authority' means--
                    ``(A) any State or local officer authorized under 
                State or local law who is employed as an investigative 
                agent of a State or local narcotics control agency;
                    ``(B) the Drug Enforcement Administration;
                    ``(C) the executive director or chief investigator, 
                as designated by each board, of the State boards of 
                podiatry, dentistry, pharmacy, medical licensure, 
                osteopathic examiners, veterinary medical examiners, 
                nursing, or other boards representing appropriate 
                health care-related disciplines, but only with respect 
                to information relevant to licensees of the respective 
                boards;
                    ``(D) the Department of Health and Human Services;
                    ``(E) a State medicaid program;
                    ``(F) a properly convened Federal or State grand 
                jury or other judicial authority pursuant to an 
                appropriately and properly issued subpoena; or
                    ``(G) any contractor selected by the Secretary to 
                establish or maintain the prescription database if the 
                Secretary imposes appropriate restrictions on such 
                contractor and its personnel.
            ``(6) The term `patient identifier' means the patient's--
                    ``(A) full name;
                    ``(B) address, including zip code;
                    ``(C) date of birth; and
                    ``(D) social security number or alternative 
                identification number.
            ``(7) The term `practitioner' means a physician, nurse 
        practitioner, clinical nurse specialist, physician assistant, 
        dentist, veterinarian, pharmacist, hospital, or other person 
        licensed, registered, or otherwise permitted under Federal or 
        State law to distribute, dispense, or administer a controlled 
        substance in the course of professional practice.
            ``(8) The term `schedule II, III, or IV controlled 
        substance' means a controlled substance (as that term is 
        defined in section 102 of the Controlled Substances Act) 
        included in schedule II, III, or IV of section 202 of such 
        Act.''.
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