[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1132 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 1132
To provide for the establishment of a controlled substance monitoring
program in each State.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 3, 2005
Mr. Whitfield (for himself, Mr. Pallone, Mr. Norwood, and Mr.
Strickland) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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. 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 a State controlled substance
monitoring program; or
``(B) to implement or make improvements to a State
controlled substance monitoring program established
with a grant under this section or 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 0.5 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 paragraph (1) 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 certain grants.--Grants awarded under this
section shall be for a term of 1 year.
``(b) Development of Minimum Standards and Recommendations.--
``(1) In general.--Not later than 30 days after the date of
enactment of this section, the Secretary shall--
``(A) develop minimum standards for use by States
in submitting their proposed standards under clauses
(ii), (v), (vi), and (vii) of subsection (c)(1)(A); and
``(B) develop recommendations with respect to
appropriate penalties for the provision or use of
information in violation of applicable Federal, State,
or local law or regulation.
``(2) Report.--Not later than 1 year after the date of
enactment of this section, the Secretary shall report to
Congress on the recommendations developed under paragraph
(1)(B).
``(c) Application Approval Process.--
``(1) In general.--To be eligible to receive a grant under
this section, a State shall submit, and have approved in
accordance with paragraph (2), 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) proposed standards 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, to the
extent practicable, applicable health
information technology standards, as determined
by the Secretary;
``(iv) proposed standards for meeting the
uniform electronic format requirement of
subsection (h);
``(v) proposed standards for availability
of information and limitation on access to
program personnel;
``(vi) proposed standards for access to the
database, and procedures to ensure database
accuracy;
``(vii) proposed standards for the
provision of information, including a
description of the certification process to be
applied to requests for information under
subsection (f);
``(viii) proposed penalties for the
provision or use of information in violation of
applicable Federal, State, or local law or
regulation; and
``(ix) 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 standards 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, including--
``(I) the technical achievement of
information sharing between the two
programs;
``(II) measures to ensure that
interoperability activities carried out
under this subsection are in compliance
with the requirements of subparagraph
(A);
``(III) measures to ensure that
proposed standards for information
access will be enforced for shared
information; and
``(IV) the completion of interstate
legal compacts necessary for such
information sharing; 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) Approval or disapproval.--
``(A) In general.--Not later than 90 days after the
submission by a State of an application under paragraph
(1), the Secretary shall approve or disapprove the
application, or request additional information as
provided under subparagraph (C). The Secretary may
disapprove an application that contains a statement
described in paragraph (1)(B)(iv), or request
additional information with respect to such a
statement, if the Secretary determines that the
approval of such application would result in the
implementation of a State program that substantially
fails to meet the goals and objectives of this section.
``(B) Approval.--The Secretary shall approve an
application submitted under paragraph (1) only if--
``(i) the plans contained in the
application meet the standards developed by the
Secretary under subsection (b); and
``(ii) the State demonstrates to the
Secretary that the State will establish and
implement or improve a controlled substance
monitoring program in accordance with this
section.
``(C) Additional information.--With respect to an
application submitted by a State under paragraph (1),
the Secretary may, during the 90-day period referred to
in subparagraph (A), request that the State provide
additional information with respect to the State
program. If such a request is made after the expiration
of the 60-day period beginning on the date on which the
application is submitted, the period under subparagraph
(A) for approval or disapproval by the Secretary shall
be extended for an additional 30 days.
``(3) Withdrawal of authorization.--Except to the extent
that a State is excused from compliance with a requirement or
standard as a result of the approval by the Secretary of a
statement under paragraph (1)(B)(iv) or under subsection (d),
if a State fails to implement or improve a controlled substance
monitoring program in accordance with this section or fails to
comply with the standards developed under this subsection--
``(A) the Secretary shall give notice of the
failure to the State; and
``(B) if the State fails to take corrective action
within a reasonable period of time, the Secretary shall
withdraw any approval of the State's application under
this section.
``(4) Voluntary discontinuance.--A funding agreement for
the receipt of a grant under this section is that the State
involved will give a reasonable period of notice to the
Secretary before ceasing to implement or operate a controlled
substance monitoring program under this section. The Secretary
shall determine the period of notice that is reasonable for
purposes of this paragraph.
``(5) Return of funds.--If the Secretary withdraws approval
of a State's application under this section, or the State
chooses to cease to 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 or research subject not later than 1 week
after the date of such dispensing.
``(2) The State may exclude from the reporting requirement
of this subsection--
``(A) the direct administration of a controlled
substance to the body of an ultimate user or research
subject;
``(B) the dispensing of a controlled substance in a
quantity limited to an amount adequate to treat the
ultimate user or research subject involved for 48 hours
or less; or
``(C) the administration or dispensing of a
controlled substance in accordance with any other
exclusion identified by the Secretary for purposes of
this paragraph.
``(3) The information to be reported under this subsection
with respect to the dispensing of a controlled substance shall
include the following:
``(A) Drug Enforcement Administration Registration
Number of the dispenser.
``(B) Drug Enforcement Administration Registration
Number and name of the practitioner who prescribed the
drug.
``(C) Name, address, and telephone number of the
ultimate user or research subject or such contact
information of the ultimate user or research subject as
the Secretary determines appropriate.
``(D) Identification of the drug by a national drug
code number.
``(E) Quantity dispensed.
``(F) Estimated number of days for which such
quantity should last.
``(G) Number of refills ordered.
``(H) Whether the drug was dispensed as a refill of
a prescription or as a first-time request.
``(I) Date of the dispensing.
``(J) Date of origin of the prescription.
``(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.
``(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 standards 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) Provision of Information.--
``(1) In general.--Subject to subsection (g), in
implementing or improving a controlled substance monitoring
program under this section, a State may provide information
from the database established under subsection (e) and, in the
case of a request under paragraph (3), summary statistics of
such information, 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.--A State that elects to exercise its
authority to notify the appropriate authorities responsible for
drug diversion investigations if information in the database
maintained by the State under subsection (e) is suggestive of
an unlawful diversion or misuse of a controlled substance, is
encouraged to develop any such notification program in
consultation with representatives of the medical community,
including physicians and pharmacists or other interested
stakeholders.
``(g) Limitations.--In implementing or improving a controlled
substance monitoring program under this section, a State--
``(1) shall make reasonable efforts to limit the
information provided pursuant to a valid request under
subsection (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 information provided in a
form and manner that prevents the identification of a provider
or patient.
``(h) Electronic Format.--The Secretary shall specify a uniform
electronic format for the reporting, sharing, and provision 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) Certain confidentiality requirements.--Nothing in
this section shall be construed as superseding the
confidentiality requirements of programs defined by and subject
to part 2 of title 42, Code of Federal Regulations.
``(5) No federal private cause of action.--Nothing in this
section shall be construed to create a Federal private cause of
action.
``(j) Relation to HIPAA.--Except to the extent inconsistent with
this section, the provision of information pursuant to subsection (f)
and the subsequent transfer of such information are subject to any
requirement that would otherwise apply under the regulations
promulgated pursuant to section 264(c) of the Health Insurance
Portability and Accountability Act of 1996.
``(k) Preference.--Beginning January 1, 2007, the Secretary, in
awarding any competitive grant that is related to drug abuse (as
determined by the Secretary) to a State, shall give preference to any
State with an application approved under this section.
``(l) Study.--Not later than 2 years after the date of the
enactment of this section, the Secretary shall--
``(1) complete a study that--
``(A) determines the progress of States in
establishing and implementing controlled substance
monitoring programs under this section;
``(B) 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;
``(C) determines the feasibility of implementing a
real-time electronic controlled substance monitoring
program, including the costs associated with
establishing such a program; and
``(D) 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 a comparison to the
privacy requirements that apply to covered entities
under regulations promulgated pursuant to section
264(c) of the Health Insurance Portability and
Accountability Act of 1996, along with any
recommendations for additional requirements for
protection of this information; and
``(E) 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
``(2) submit a report to the Congress on the results of the
study.
``(m) 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) 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.
``(n) Definitions.--For purposes of this section:
``(1) The term `bona fide patient' means an individual who
is a patient of the dispenser or 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 or research subject by, or
pursuant to the lawful order of, a practitioner, irrespective
of whether the dispenser uses the Internet or other means to
effect such delivery.
``(4) The term `dispenser' means a physician, pharmacist,
or other individual who dispenses a controlled substance to an
ultimate user or research subject.
``(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 or research subject 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 is provided in a form and manner that prevents
the identification of a provider or patient.
``(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
lawfully obtained, 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.
``(o) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated--
``(1) $25,000,000 for each of fiscal years 2006 and 2007;
and
``(2) $15,000,000 for each of fiscal years 2008, 2009, and
2010.''.
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