[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1132 Received in Senate (RDS)]
109th CONGRESS
1st Session
H. R. 1132
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 28, 2005
Received
_______________________________________________________________________
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 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. 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.
``(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) 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);
``(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).
``(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
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).
``(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) 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
``(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) 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.
``(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) 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 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.
``(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.''.
Passed the House of Representatives July 27, 2005.
Attest:
JEFF TRANDAHL,
Clerk.