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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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