[109th Congress Public Law 60]
[From the U.S. Government Printing Office]
[DOCID: f:publ060.109]
[[Page 119 STAT. 1979]]
Public Law 109-60
109th Congress
An Act
To provide for the establishment of a controlled substance monitoring
program in each State. <<NOTE: Aug. 11, 2005 - [H.R. 1132]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: National All
Schedules Prescription Electronic Reporting Act of 2005. Health and
health care. 42 USC 201 note. 42 USC 280g-3 note.>>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National All Schedules Prescription
Electronic Reporting Act of 2005''.
SEC. 2. PURPOSE.
It is the purpose of this Act to--
(1) foster the establishment of State-administered
controlled 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
practices 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. <<NOTE: 42 USC 280g-3.>> 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
controlled 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.
[[Page 119 STAT. 1980]]
``(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 consideration 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) <<NOTE: Deadline. Federal Register, publication.>> 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 Federal 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 substance 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 appropriate encryption technology
or other appropriate technology 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 procedures to ensure that information in the
database is accurate;
``(vii) criteria for the use and disclosure of
information, including a description of the
certification process to be applied to requests
for information under subsection (f);
[[Page 119 STAT. 1981]]
``(viii) penalties for the unauthorized use
and disclosure of information maintained in the
State controlled substance monitoring program in
violation of applicable State law or regulation;
``(ix) information on the relevant State laws,
policies, 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 substance 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
substance monitoring program to achieve
interoperability with at least one other State
controlled substance monitoring 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
demonstrate 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
maintained in such program.
``(3) Interoperability.--If a State that submits an
application 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
interoperability 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
monitoring programs of such States.
``(4) Approval.--If a State submits an application in
accordance 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 Secretary at the time of the grant).
[[Page 119 STAT. 1982]]
``(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) <<NOTE: Deadline.>> 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
ultimate 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
ultimate 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 substance
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).
[[Page 119 STAT. 1983]]
``(2) The database must be searchable by any field or
combination 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
implementing or improving a controlled substance monitoring
program 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) <<NOTE: Certification.>> 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 medical or
pharmaceutical treatment or evaluating the need for such
treatment to a bona fide current patient;
``(B) any local, State, or Federal law enforcement,
narcotics control, licensure, disciplinary, or program
authority, who certifies, under the procedures
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 investigation 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 maintenance of that State's controlled substance
monitoring program, 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 monitoring 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 substances; and
[[Page 119 STAT. 1984]]
``(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
information.
``(h) <<NOTE: Records.>> Electronic Format.--The Secretary shall
specify a uniform 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
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, 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 section
shall be construed to supersede any Federal privacy or
confidentiality requirement, including the regulations
promulgated 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
monitoring 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 scientific
investigator conducting such research or clinical
trial or the agent thereof.
[[Page 119 STAT. 1985]]
``(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 additional 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
establishing and implementing controlled substance
monitoring programs under this section;
``(ii) provides an analysis of the extent to
which the operation of controlled substance
monitoring programs have reduced inappropriate
use, abuse, or diversion of controlled substances
or affected patient access to appropriate pain
care in States operating such programs;
``(iii) determines the progress of States in
achieving interoperability between controlled
substance monitoring programs, including an
assessment of technical and legal barriers to such
activities and recommendations for addressing
these barriers;
``(iv) determines the feasibility of
implementing a real-time electronic controlled
substance monitoring program, including the costs
associated with establishing 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 systems, in
controlled substance monitoring programs and the
potential for such alternatives to enhance the
privacy 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) <<NOTE: Effective date.>> 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 application 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
[[Page 119 STAT. 1986]]
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
substance 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 principal place of
business is located in such other State.
``(6) The term `nonidentifiable information' means
information 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
practices 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.
[[Page 119 STAT. 1987]]
``(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.
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,
Education, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 151 (2005):
July 27, considered and passed House.
July 29, considered and passed Senate.
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