108TH CONGRESS
2D SESSION
H. R. 3015
AN ACT
To provide for the establishment of a controlled
substance monitoring program in each State.
108TH CONGRESS
2D SESSION
H. R. 3015
AN ACT
To provide for the establishment of a controlled substance
monitoring program in each State.
Be it enacted by the Senate and House of Representa-
tives 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 2004’’.
SEC. 2. CONTROLLED SUBSTANCE MONITORING PROGRAM.
Part P of title III of the Public Health Service Act
(42 U.S.C. 280g et seq.) is amended by adding after sec-
tion 399N the following:
‘‘SEC. 399O. CONTROLLED SUBSTANCE MONITORING PRO-
GRAM.
‘‘(a) FORMULA GRANTS.—
‘‘(1) IN GENERAL.—Each fiscal year, the Sec-
retary shall make a payment to each State with an
application approved under this section for the pur-
pose of establishing and implementing a controlled
substance monitoring program under this section.
‘‘(2) DETERMINATION OF AMOUNT.—In making
payments under paragraph (1) for a fiscal year, the
Secretary shall allocate to each State with an appli-
cation approved under this section an amount which
bears the same ratio to the amount appropriated to
carry out this section for that fiscal year as the
number of pharmacies of the State bears to the
number of pharmacies of all States with applications
approved under this section (as determined by the
Secretary), except that the Secretary may adjust the
amount allocated to a State under this paragraph
after taking into consideration the budget cost esti-
mate for the State’s controlled substance monitoring
program.
‘‘(b) APPLICATION APPROVAL PROCESS.—
‘‘(1) IN GENERAL.—To seek a grant under this
section, a State shall submit an application at such
time, in such manner, and containing such assur-
ances and information as the Secretary may reason-
ably require. Each such application shall include—
‘‘(A) a budget cost estimate for the State’s
controlled substance monitoring program;
‘‘(B) proposed standards for security for
information handling and for the database
maintained by the State under subsection (d)
generally including efforts to use appropriate
encryption technology or other such technology;
‘‘(C) proposed standards for meeting the
uniform electronic format requirement of sub-
section (g);
‘‘(D) proposed standards for availability of
information and limitation on access to pro-
gram personnel;
‘‘(E) proposed standards for access to the
database, and procedures to ensure database
accuracy;
‘‘(F) proposed standards for redisclosure
of information;
‘‘(G) proposed penalties for illegal redisclo-
sure of information; and
‘‘(H) assurances of compliance with all
other requirements of this section.
‘‘(2) APPROVAL
OR
DISAPPROVAL.—Not later
than 90 days after the submission by a State of an
application under paragraph (1), the Secretary shall
approve or disapprove the application. The Secretary
shall approve the application if the State dem-
onstrates to the Secretary that the State will estab-
lish and implement or operate a controlled substance
monitoring program in accordance with this section.
‘‘(3) WITHDRAWAL OF AUTHORIZATION.—If a
State fails to implement a controlled substance mon-
itoring program in accordance with this section—
‘‘(A) the Secretary shall give notice of the
failure to the State; and
‘‘(B) if the State fails to take corrective
action within a reasonable period of time, the
Secretary shall withdraw any approval of the
State’s application under this section.
‘‘(4) VOLUNTARY DISCONTINUANCE.—A fund-
ing agreement for the receipt of a payment under
this section is that the State involved will give a rea-
sonable period of notice to the Secretary before ceas-
ing to implement or operate a controlled substance
monitoring program under this section. The Sec-
retary shall determine the period of notice that is
reasonable for purposes of this paragraph.
‘‘(5) RETURN
OF
FUNDS.—If the Secretary
withdraws approval of a State’s application under
this section, or the State chooses to cease to imple-
ment a controlled substance monitoring program
under this section, a funding agreement for the re-
ceipt of a payment under this section is that the
State will return to the Secretary an amount which
bears the same ratio to the overall payment as the
remaining time period for expending the payment
bears to the overall time period for expending the
payment (as specified by the Secretary at the time
of the payment).
‘‘(c) REPORTING REQUIREMENTS.—In implementing
a controlled substance monitoring program under this sec-
tion, a State shall comply with the following:
‘‘(1) The State shall require dispensers to re-
port to such State each dispensing in the State of
a controlled substance to an ultimate user or re-
search subject not later than 1 week after the date
of such dispensing.
‘‘(2) The State may exclude from the reporting
requirement of this subsection—
‘‘(A) the direct administration of a con-
trolled substance to the body of an ultimate
user or research subject;
‘‘(B) the dispensing of a controlled sub-
stance in a quantity limited to an amount ade-
quate to treat the ultimate user or research
subject involved for 48 hours or less; or
‘‘(C) the administration or dispensing of a
controlled substance in accordance with any
other exclusion identified by the Secretary for
purposes of this paragraph.
‘‘(3) The information to be reported under this
subsection with respect to the dispensing of a con-
trolled substance shall include the following:
‘‘(A) Drug Enforcement Administration
Registration Number of the dispenser.
‘‘(B) Drug Enforcement Administration
Registration Number and name of the practi-
tioner who prescribed the drug.
‘‘(C) Name, address, and telephone num-
ber of the ultimate user or research subject.
‘‘(D) Identification of the drug by a na-
tional drug code number.
‘‘(E) Quantity dispensed.
‘‘(F) Estimated number of days for which
such quantity should last.
‘‘(G) Number of refills ordered.
‘‘(H) Whether the drug was dispensed as
a refill of a prescription or as a first-time re-
quest.
‘‘(I) Date of the dispensing.
‘‘(J) Date of origin of the prescription.
‘‘(4) The State shall require dispensers to re-
port information under this section in accordance
with the electronic format specified by the Secretary
under subsection (g), except that the State may
waive the requirement of such format with respect to
an individual dispenser.
‘‘(5) The State shall automatically share infor-
mation reported under this subsection with another
State with an application approved under this sec-
tion if the information concerns—
‘‘(A) the dispensing of a controlled sub-
stance to an ultimate user or research subject
who resides in such other State; or
‘‘(B) the dispensing of a controlled sub-
stance prescribed by a practitioner whose prin-
cipal place of business is located in such other
State.
‘‘(6) The State may notify the appropriate au-
thorities responsible for drug diversion investigation
if information in the database maintained by the
State under subsection (d) indicates an unlawful di-
version or misuse of a controlled substance.
‘‘(d) DATABASE.—In implementing a controlled sub-
stance monitoring program under this section, a State
shall comply with the following:
‘‘(1) The State shall establish and maintain an
electronic database containing the information re-
ported to the State under subsection (c).
‘‘(2) The database must be searchable by any
field or combination of fields.
‘‘(3) The State shall include reported informa-
tion in the database at such time and in such man-
ner as the Secretary determines appropriate, with
appropriate safeguards for ensuring the accuracy
and completeness of the database.
‘‘(4) The State shall take appropriate security
measures to protect the integrity of, and access to,
the database.
‘‘(e) PROVISION OF INFORMATION.—Subject to sub-
section (f), in implementing a controlled substance moni-
toring program under this section, a State may provide
information from the database established under sub-
section (d) and, in the case of a request under paragraph
(3), summary statistics of such information, in response
to a request by—
‘‘(1) a practitioner (or the agent thereof) who
certifies, under the procedures determined by the
State, that the requested information is for the pur-
pose of providing medical or pharmaceutical treat-
ment or evaluating the need for such treatment to
a bona fide current patient;
‘‘(2) any local, State, or Federal law enforce-
ment, narcotics control, licensure, disciplinary, or
program authority, who certifies, under the proce-
dures determined by the State, that the requested
information is related to an individual investigation
or proceeding involving the unlawful diversion or
misuse of a schedule II, III, or IV substance, and
such information will further the purpose of the in-
vestigation or assist in the proceeding;
‘‘(3) any agent of the Department of Health
and Human Services, a State medicaid program, a
State health department, or the Drug Enforcement
Administration who certifies that the requested in-
formation is necessary for research to be conducted
by such department, program, or administration, re-
spectively, and the intended purpose of the research
is related to a function committed to such depart-
ment, program, or administration by law that is not
investigative in nature; or
‘‘(4) any agent of another State, who certifies
that the State has an application approved under
this section and the requested information is for the
purpose of implementing the State’s controlled sub-
stance monitoring program under this section.
‘‘(f) LIMITATIONS.—In implementing a controlled
substance monitoring program under this section, a
State—
‘‘(1) shall make reasonable efforts to limit the
information provided pursuant to a valid request
under subsection (e) to the minimum necessary to
accomplish the intended purpose of the request; and
‘‘(2) shall not provide any individually identifi-
able information in response to a request under sub-
section (e)(3).
‘‘(g) ELECTRONIC FORMAT.—The Secretary shall
specify a uniform electronic format for the reporting, shar-
ing, and provision of information under this section.
‘‘(h) RULES OF CONSTRUCTION.—
‘‘(1) FUNCTIONS OTHERWISE AUTHORIZED BY
LAW.—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 perform functions otherwise authorized by law.
‘‘(2) NO PREEMPTION.—Nothing in this section
shall be construed as preempting any State law, ex-
cept that no such law may relieve any person of a
requirement otherwise applicable under this Act.
‘‘(3) ADDITIONAL
PRIVACY
PROTECTIONS.—
Nothing in this section shall be construed as pre-
empting any State from imposing any additional pri-
vacy protections.
‘‘(4) CERTAIN
CONFIDENTIALITY
REQUIRE-
MENTS.—Nothing in this section shall be construed
as superceding the confidentiality requirements of
programs defined by and subject to part 2 of title
42, Code of Federal Regulations.
‘‘(5) NO
FEDERAL
PRIVATE
CAUSE
OF
AC-
TION.—Nothing in this section shall be construed to
create a Federal private cause of action.
‘‘(i) RELATION TO HIPAA.—Except to the extent in-
consistent with this section, the provision of information
pursuant to subsection (c)(5), (c)(6), or (e) and the subse-
quent transfer of such information are subject to any re-
quirement that would otherwise apply under the regula-
tions promulgated pursuant to section 264(c) of the
Health Insurance Portability and Accountability Act of
1996.
‘‘(j) PREFERENCE.—Beginning January 1, 2007, the
Secretary, in awarding any competitive grant that is re-
lated to drug abuse (as determined by the Secretary) to
a State, shall give preference to any State with an applica-
tion approved under this section.
‘‘(k) STUDY.—Not later than 2 years after the date
of the enactment of this section, the Secretary shall—
‘‘(1) complete a study that—
‘‘(A) determines the progress of States in
establishing and implementing controlled sub-
stance monitoring programs under this section;
‘‘(B) determines the feasibility of imple-
menting a real-time electronic controlled sub-
stance monitoring program, including the costs
associated with establishing such a program;
and
‘‘(C) provides an analysis of the privacy
protections in place for the information re-
ported to the controlled substance monitoring
program in each State receiving a grant for the
establishment or operation of such program,
and a comparison to the privacy requirements
that apply to covered entities under regulations
promulgated pursuant to section 264(c) of the
Health Insurance Portability and Accountability
Act of 1996, along with any recommendations
for additional requirements for protection of
this information; and
‘‘(2) submit a report to the Congress on the re-
sults of the study.
‘‘(l) ADVISORY COUNCIL.—
‘‘(1) ESTABLISHMENT.—A State may establish
an advisory council to assist in the establishment
and implementation of a controlled substance moni-
toring program under this section.
‘‘(2) SENSE OF CONGRESS.—It is the sense of
the Congress that, in establishing an advisory coun-
cil under this subsection, a State should consult with
appropriate professional boards and other interested
parties.
‘‘(m) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘bona fide patient’ means an in-
dividual who is a patient of the dispenser or practi-
tioner involved.
‘‘(2) The term ‘controlled substance’ means a
drug that is included in schedule II, III, or IV of
section 202(c) of the Controlled Substance Act.
‘‘(3) The term ‘dispense’ means to deliver a
controlled substance to an ultimate user or research
subject by, or pursuant to the lawful order of, a
practitioner, irrespective of whether the dispenser
uses the Internet or other means to effect such deliv-
ery.
‘‘(4) The term ‘dispenser’ means a physician,
pharmacist, or other individual who dispenses a con-
trolled substance to an ultimate user or research
subject.
‘‘(5) The term ‘practitioner’ means a physician,
dentist, veterinarian, scientific investigator, phar-
macy, hospital, or other person licensed, registered,
or otherwise permitted, by the United States or the
jurisdiction in which he or she practices or does re-
search, to distribute, dispense, conduct research with
respect to, administer, or use in teaching or chemical
analysis, a controlled substance in the course of pro-
fessional practice or research.
‘‘(6) The term ‘State’ means each of the 50
States and the District of Columbia.
‘‘(7) The term ‘ultimate user’ means a person
who has lawfully obtained, and who possesses, a con-
trolled substance for his or her own use, for the use
of a member of his or her household, or for the use
of an animal owned by him or her or by a member
of his or her household.
‘‘(n) AUTHORIZATION
OF
APPROPRIATIONS.—To
carry out this section, there are authorized to be
appropriated—
‘‘(1) $25,000,000 for each of fiscal years 2006
and 2007; and
‘‘(2) $15,000,000 for each of fiscal years 2008,
2009, and 2010.’’.
Passed the House of Representatives October 5,
2004.
Attest:
Clerk.