[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1132 Enrolled Bill (ENR)]
H.R.1132
One Hundred Ninth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the fourth day of January, two thousand and five
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.''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.