National All Schedules Prescription Electronic Reporting Act of 2005
PL 109-60 (H.R.1132), enacted 08/11/2005

119 STAT. 1979
PUBLIC LAW 109–60—AUG. 11, 2005
Public Law 109–60
109th Congress
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 Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘National All Schedules Prescrip-
tion Electronic Reporting Act of 2005’’.
SEC. 2. PURPOSE.
It is the purpose of this Act to—
(1) foster the establishment of State-administered con-
trolled substance monitoring systems in order to ensure that
health care providers have access to the accurate, timely
prescription history information that they may use as a tool
for the early identification of patients at risk for addiction
in order to initiate appropriate medical interventions and avert
the tragic personal, family, and community consequences of
untreated addiction; and
(2) establish, based on the experiences of existing State
controlled substance monitoring programs, a set of best prac-
tices to guide the establishment of new State programs and
the improvement of existing programs.
SEC. 3. 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 section 399N the following:
‘‘SEC. 399O. CONTROLLED SUBSTANCE MONITORING PROGRAM.
‘‘(a) GRANTS.—
‘‘(1) IN
GENERAL.—Each fiscal year, the Secretary shall
award a grant to each State with an application approved
under this section to enable the State—
‘‘(A) to establish and implement a State controlled
substance monitoring program; or
‘‘(B) to make improvements to an existing State con-
trolled substance monitoring program.
‘‘(2) DETERMINATION OF AMOUNT.—
‘‘(A) MINIMUM AMOUNT.—In making payments under
a grant under paragraph (1) for a fiscal year, the Secretary
shall allocate to each State with an application approved
under this section an amount that equals 1.0 percent of
the amount appropriated to carry out this section for that
fiscal year.
42 USC 280g–3.
National All
Schedules
Prescription
Electronic
Reporting Act
of 2005.
Health and
health care.
42 USC 201 note.
42 USC 280g–3
note.
Aug. 11, 2005
[H.R. 1132]
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PUBLIC LAW 109–60—AUG. 11, 2005
‘‘(B) ADDITIONAL
AMOUNTS.—In making payments
under a grant under paragraph (1) for a fiscal year, the
Secretary shall allocate to each State with an application
approved under this section an additional amount which
bears the same ratio to the amount appropriated to carry
out this section for that fiscal year and remaining after
amounts are made available under subparagraph (A) 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 subparagraph after taking into consider-
ation the budget cost estimate for the State’s controlled
substance monitoring program.
‘‘(3) TERM OF GRANTS.—Grants awarded under this section
shall be obligated in the year in which funds are allotted.
‘‘(b) DEVELOPMENT
OF
MINIMUM
REQUIREMENTS.—Prior to
awarding a grant under this section, and not later than 6 months
after the date on which funds are first appropriated to carry out
this section, after seeking consultation with States and other
interested parties, the Secretary shall, after publishing in the Fed-
eral Register proposed minimum requirements and receiving public
comments, establish minimum requirements for criteria to be used
by States for purposes of clauses (ii), (v), (vi), and (vii) of subsection
(c)(1)(A).
‘‘(c) APPLICATION APPROVAL PROCESS.—
‘‘(1) IN GENERAL.—To be eligible to receive a grant under
this section, a State shall submit an application to the Secretary
at such time, in such manner, and containing such assurances
and information as the Secretary may reasonably require. Each
such application shall include—
‘‘(A) with respect to a State that intends to use funds
under the grant as provided for in subsection (a)(1)(A)—
‘‘(i) a budget cost estimate for the controlled sub-
stance monitoring program to be implemented under
the grant;
‘‘(ii) criteria for security for information handling
and for the database maintained by the State under
subsection (e) generally including efforts to use appro-
priate encryption technology or other appropriate tech-
nology to protect the security of such information;
‘‘(iii) an agreement to adopt health information
interoperability standards, including health vocabulary
and messaging standards, that are consistent with any
such standards generated or identified by the Secretary
or his or her designee;
‘‘(iv) criteria for meeting the uniform electronic
format requirement of subsection (h);
‘‘(v) criteria for availability of information and
limitation on access to program personnel;
‘‘(vi) criteria for access to the database, and proce-
dures to ensure that information in the database is
accurate;
‘‘(vii) criteria for the use and disclosure of informa-
tion, including a description of the certification process
to be applied to requests for information under sub-
section (f);
Deadline.
Federal Register,
publication.
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PUBLIC LAW 109–60—AUG. 11, 2005
‘‘(viii) penalties for the unauthorized use and
disclosure of information maintained in the State con-
trolled substance monitoring program in violation of
applicable State law or regulation;
‘‘(ix) information on the relevant State laws, poli-
cies, and procedures, if any, regarding purging of
information from the database; and
‘‘(x) assurances of compliance with all other
requirements of this section; or
‘‘(B) with respect to a State that intends to use funds
under the grant as provided for in subsection (a)(1)(B)—
‘‘(i) a budget cost estimate for the controlled sub-
stance monitoring program to be improved under the
grant;
‘‘(ii) a plan for ensuring that the State controlled
substance monitoring program is in compliance with
the criteria and penalty requirements described in
clauses (ii) through (viii) of subparagraph (A);
‘‘(iii) a plan to enable the State controlled sub-
stance monitoring program to achieve interoperability
with at least one other State controlled substance moni-
toring program; and
‘‘(iv) assurances of compliance with all other
requirements of this section or a statement describing
why such compliance is not feasible or is contrary
to the best interests of public health in such State.
‘‘(2) STATE LEGISLATION.—As part of an application under
paragraph (1), the Secretary shall require a State to dem-
onstrate that the State has enacted legislation or regulations
to permit the implementation of the State controlled substance
monitoring program and the imposition of appropriate penalties
for the unauthorized use and disclosure of information main-
tained in such program.
‘‘(3) INTEROPERABILITY.—If a State that submits an applica-
tion under this subsection geographically borders another State
that is operating a controlled substance monitoring program
under subsection (a)(1) on the date of submission of such
application, and such applicant State has not achieved inter-
operability for purposes of information sharing between its
monitoring program and the monitoring program of such border
State, such applicant State shall, as part of the plan under
paragraph (1)(B)(iii), describe the manner in which the
applicant State will achieve interoperability between the moni-
toring programs of such States.
‘‘(4) APPROVAL.—If a State submits an application in accord-
ance with this subsection, the Secretary shall approve such
application.
‘‘(5) RETURN
OF
FUNDS.—If the Secretary withdraws
approval of a State’s application under this section, or the
State chooses to cease to implement or improve a controlled
substance monitoring program under this section, a funding
agreement for the receipt of a grant under this section is
that the State will return to the Secretary an amount which
bears the same ratio to the overall grant as the remaining
time period for expending the grant funds bears to the overall
time period for expending the grant (as specified by the Sec-
retary at the time of the grant).
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119 STAT. 1982
PUBLIC LAW 109–60—AUG. 11, 2005
‘‘(d) REPORTING REQUIREMENTS.—In implementing or improving
a controlled substance monitoring program under this section, a
State shall comply, or with respect to a State that applies for
a grant under subsection (a)(1)(B) submit to the Secretary for
approval a statement of why such compliance is not feasible or
is contrary to the best interests of public health in such State,
with the following:
‘‘(1) The State shall require dispensers to report to such
State each dispensing in the State of a controlled substance
to an ultimate user 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 controlled substance
to the body of an ultimate user;
‘‘(B) the dispensing of a controlled substance in a
quantity limited to an amount adequate to treat the ulti-
mate user 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 controlled substance shall
include the following:
‘‘(A) Drug Enforcement Administration Registration
Number (or other identifying number used in lieu of such
Registration Number) of the dispenser.
‘‘(B) Drug Enforcement Administration Registration
Number (or other identifying number used in lieu of such
Registration Number) and name of the practitioner who
prescribed the drug.
‘‘(C) Name, address, and telephone number of the ulti-
mate user or such contact information of the ultimate user
as the Secretary determines appropriate.
‘‘(D) Identification of the drug by a national drug code
number.
‘‘(E) Quantity dispensed.
‘‘(F) Number of refills ordered.
‘‘(G) Whether the drug was dispensed as a refill of
a prescription or as a first-time request.
‘‘(H) Date of the dispensing.
‘‘(I) Date of origin of the prescription.
‘‘(J) Such other information as may be required by
State law to be reported under this subsection.
‘‘(4) The State shall require dispensers to report information
under this section in accordance with the electronic format
specified by the Secretary under subsection (h), except that
the State may waive the requirement of such format with
respect to an individual dispenser that is unable to submit
such information by electronic means.
‘‘(e) DATABASE.—In implementing or improving 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 reported to the State under
subsection (d).
Deadline.
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PUBLIC LAW 109–60—AUG. 11, 2005
‘‘(2) The database must be searchable by any field or com-
bination of fields.
‘‘(3) The State shall include reported information in the
database in a manner consistent with criteria established by
the Secretary, 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.
‘‘(f) USE AND DISCLOSURE OF INFORMATION.—
‘‘(1) IN
GENERAL.—Subject to subsection (g), in imple-
menting or improving a controlled substance monitoring pro-
gram under this section, a State may disclose information from
the database established under subsection (e) and, in the case
of a request under subparagraph (D), summary statistics of
such information, only in response to a request by—
‘‘(A) a practitioner (or the agent thereof) who certifies,
under the procedures determined by the State, that the
requested information is for the purpose of providing med-
ical or pharmaceutical treatment or evaluating the need
for such treatment to a bona fide current patient;
‘‘(B) any local, State, or Federal law enforcement, nar-
cotics control, licensure, disciplinary, or program authority,
who certifies, under the procedures determined by the
State, that the requested information is related to an indi-
vidual 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 inves-
tigation or assist in the proceeding;
‘‘(C) the controlled substance monitoring program of
another State or group of States with whom the State
has established an interoperability agreement;
‘‘(D) 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 information is necessary for
research to be conducted by such department, program,
or administration, respectively, and the intended purpose
of the research is related to a function committed to such
department, program, or administration by law that is
not investigative in nature; or
‘‘(E) an agent of the State agency or entity of another
State that is responsible for the establishment and mainte-
nance of that State’s controlled substance monitoring pro-
gram, who certifies that—
‘‘(i) the State has an application approved under
this section; and
‘‘(ii) the requested information is for the purpose
of implementing the State’s controlled substance moni-
toring program under this section.
‘‘(2) DRUG DIVERSION.—In consultation with practitioners,
dispensers, and other relevant and interested stakeholders, a
State receiving a grant under subsection (a)—
‘‘(A) shall establish a program to notify practitioners
and dispensers of information that will help identify and
prevent the unlawful diversion or misuse of controlled sub-
stances; and
Certification.
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119 STAT. 1984
PUBLIC LAW 109–60—AUG. 11, 2005
‘‘(B) may, to the extent permitted under State law,
notify the appropriate authorities responsible for carrying
out drug diversion investigations if the State determines
that information in the database maintained by the State
under subsection (e) indicates an unlawful diversion or
abuse of a controlled substance.
‘‘(g) LIMITATIONS.—In implementing or improving a controlled
substance monitoring program under this section, a State—
‘‘(1) shall limit the information provided pursuant to a
valid request under subsection (f)(1) to the minimum necessary
to accomplish the intended purpose of the request; and
‘‘(2) shall limit information provided in response to a
request under subsection (f)(1)(D) to nonidentifiable informa-
tion.
‘‘(h) ELECTRONIC FORMAT.—The Secretary shall specify a uni-
form electronic format for the reporting, sharing, and disclosure
of information under this section.
‘‘(i) 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 enforce-
ment, narcotics control, licensure, disciplinary, or program
authority, to perform functions otherwise authorized by law.
‘‘(2) NO PREEMPTION.—Nothing in this section shall be con-
strued as preempting any State law, except 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 preempting any State from
imposing any additional privacy protections.
‘‘(4) FEDERAL PRIVACY REQUIREMENTS.—Nothing in this sec-
tion shall be construed to supersede any Federal privacy or
confidentiality requirement, including the regulations promul-
gated under section 264(c) of the Health Insurance Portability
and Accountability Act of 1996 (Public Law 104–191; 110 Stat.
2033) and section 543 of the Public Health Service Act.
‘‘(5) NO FEDERAL PRIVATE CAUSE OF ACTION.—Nothing in
this section shall be construed to create a Federal private
cause of action.
‘‘(j) STUDIES AND REPORTS.—
‘‘(1) IMPLEMENTATION REPORT.—
‘‘(A) IN GENERAL.—Not later than 180 days after the
date of enactment of this section, the Secretary, based
on a review of existing State controlled substance moni-
toring programs and other relevant information, shall
determine whether the implementation of such programs
has had a substantial negative impact on—
‘‘(i) patient access to treatment, including therapy
for pain or controlled substance abuse;
‘‘(ii) pediatric patient access to treatment; or
‘‘(iii) patient enrollment in research or clinical
trials in which, following the protocol that has been
approved by the relevant institutional review board
for the research or clinical trial, the patient has
obtained a controlled substance from either the sci-
entific investigator conducting such research or clinical
trial or the agent thereof.
Records.
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119 STAT. 1985
PUBLIC LAW 109–60—AUG. 11, 2005
‘‘(B) ADDITIONAL
CATEGORIES
OF
EXCLUSION.—If the
Secretary determines under subparagraph (A) that a
substantial negative impact has been demonstrated with
regard to one or more of the categories of patients described
in such subparagraph, the Secretary shall identify addi-
tional appropriate categories of exclusion from reporting
as authorized under subsection (d)(2)(C).
‘‘(2) PROGRESS REPORT.—Not later than 3 years after the
date on which funds are first appropriated under this section,
the Secretary shall—
‘‘(A) complete a study that—
‘‘(i) determines the progress of States in estab-
lishing and implementing controlled substance moni-
toring programs under this section;
‘‘(ii) provides an analysis of the extent to which
the operation of controlled substance monitoring pro-
grams have reduced inappropriate use, abuse, or diver-
sion of controlled substances or affected patient access
to appropriate pain care in States operating such pro-
grams;
‘‘(iii) determines the progress of States in achieving
interoperability between controlled substance moni-
toring programs, including an assessment of technical
and legal barriers to such activities and recommenda-
tions for addressing these barriers;
‘‘(iv) determines the feasibility of implementing a
real-time electronic controlled substance monitoring
program, including the costs associated with estab-
lishing such a program;
‘‘(v) provides an analysis of the privacy protections
in place for the information reported to the controlled
substance monitoring program in each State receiving
a grant for the establishment or operation of such
program, and any recommendations for additional
requirements for protection of this information;
‘‘(vi) determines the feasibility of implementing
technological alternatives to centralized data storage,
such as peer-to-peer file sharing or data pointer sys-
tems, in controlled substance monitoring programs and
the potential for such alternatives to enhance the pri-
vacy and security of individually identifiable data; and
‘‘(vii) evaluates the penalties that States have
enacted for the unauthorized use and disclosure of
information maintained in the controlled substance
monitoring program, and reports on the criteria used
by the Secretary to determine whether such penalties
qualify as appropriate pursuant to this section; and
‘‘(B) submit a report to the Congress on the results
of the study.
‘‘(k) PREFERENCE.—Beginning 3 years after the date on which
funds are first appropriated to carry out this section, the Secretary,
in awarding any competitive grant that is related to drug abuse
(as determined by the Secretary) and for which only States are
eligible to apply, shall give preference to any State with an applica-
tion approved under this section. The Secretary shall have the
discretion to apply such preference to States with existing controlled
substance monitoring programs that meet minimum requirements
Effective date.
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PUBLIC LAW 109–60—AUG. 11, 2005
under this section or to States that put forth a good faith effort
to meet those requirements (as determined by the Secretary).
‘‘(l) ADVISORY COUNCIL.—
‘‘(1) ESTABLISHMENT.—A State may establish an advisory
council to assist in the establishment, implementation, or
improvement of a controlled substance monitoring program
under this section.
‘‘(2) LIMITATION.—A State may not use amounts received
under a grant under this section for the operations of an
advisory council established under paragraph (1).
‘‘(3) SENSE OF CONGRESS.—It is the sense of the Congress
that, in establishing an advisory council 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 individual who
is a patient of the practitioner 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 sub-
stance to an ultimate user by, or pursuant to the lawful order
of, a practitioner, irrespective of whether the dispenser uses
the Internet or other means to effect such delivery.
‘‘(4) The term ‘dispenser’ means a physician, pharmacist,
or other person that dispenses a controlled substance to an
ultimate user.
‘‘(5) The term ‘interoperability’ with respect to a State
controlled substance monitoring program means the ability of
the program to electronically share reported information,
including each of the required report components described
in subsection (d), with another State if the information concerns
either the dispensing of a controlled substance to an ultimate
user who resides in such other State, or the dispensing of
a controlled substance prescribed by a practitioner whose prin-
cipal place of business is located in such other State.
‘‘(6) The term ‘nonidentifiable information’ means informa-
tion that does not identify a practitioner, dispenser, or an
ultimate user and with respect to which there is no reasonable
basis to believe that the information can be used to identify
a practitioner, dispenser, or an ultimate user.
‘‘(7) The term ‘practitioner’ means a physician, dentist,
veterinarian, scientific investigator, pharmacy, hospital, or
other person licensed, registered, or otherwise permitted, by
the United States or the jurisdiction in which he or she prac-
tices or does research, to distribute, dispense, conduct research
with respect to, administer, or use in teaching or chemical
analysis, a controlled substance in the course of professional
practice or research.
‘‘(8) The term ‘State’ means each of the 50 States and
the District of Columbia.
‘‘(9) The term ‘ultimate user’ means a person who has
obtained from a dispenser, and who possesses, a controlled
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.
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119 STAT. 1987
PUBLIC LAW 109–60—AUG. 11, 2005
LEGISLATIVE HISTORY—H.R. 1132 (S. 518):
HOUSE REPORTS: No. 109–191 (Comm. on Energy and Commerce).
SENATE REPORTS: No. 109–117 accompanying S. 518 (Comm. on Health, Edu-
cation, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 151 (2005):
July 27, considered and passed House.
July 29, considered and passed Senate.
‘‘(n) AUTHORIZATION
OF APPROPRIATIONS.—To carry out this
section, there are authorized to be appropriated—
‘‘(1) $15,000,000 for each of fiscal years 2006 and 2007;
and
‘‘(2) $10,000,000 for each of fiscal years 2008, 2009, and
2010.’’.
Approved August 11, 2005.
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