Home > 105th Congressional Bills > S. 2288 (rs) To provide for the reform and continuing legislative oversight of the production, procurement, dissemination, and permanent public access of the Government's publications, and for other purposes. ...S. 2288 (rs) To provide for the reform and continuing legislative oversight of the production, procurement, dissemination, and permanent public access of the Government's publications, and for other purposes. ...
108th CONGRESS
2d Session
S. 2288
To amend the Public Health Service Act to assist States in
establishing, maintaining, and improving systems to reduce the
diversion and abuse of prescription drugs.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 6, 2004
Ms. Collins introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to assist States in
establishing, maintaining, and improving systems to reduce the
diversion and abuse of prescription drugs.
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 ``Prescription Drug Stewardship Act''.
SEC. 2. PRESCRIPTION DRUG STEWARDSHIP.
Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
is amended by adding at the end the following:
``PART J--PRESCRIPTION DRUG STEWARDSHIP
``SEC. 596. PURPOSE.
``It is the purpose of this part to provide grants to assist States
in establishing, maintaining, and improving systems to--
``(1) track the distribution of prescription drugs from the
prescribing health care providers to the pharmacy and, finally,
to the patient;
``(2) provide continuing education programs for health care
providers concerning issues pertaining to prescription drug
abuse among patients and colleagues; and
``(3) provide education programs for the public on the
problem of prescription drug diversion and abuse.
``SEC. 596A. GRANT AUTHORITY.
``The Secretary, acting through the Administrator of the Substance
Abuse and Mental Health Services Administration, shall establish a
program to award competitive grants, payable over 3 years, to States
under sections 596B through 596D to establish, maintain, and improve
prescription drug monitoring and education. A State may receive a grant
under one or more of such sections.
``SEC. 596B. PRESCRIPTION DRUG MONITORING GRANTS.
``(a) Eligibility.--To be eligible for a grant under this section,
a State shall--
``(1) have in effect, or have enacted within 1 year of
receiving such a grant, laws or policies meeting the
requirements of subsection (c) that require the periodic and
regular reporting by pharmacies of data on prescriptions
filled;
``(2) prepare and submit to the Secretary an application in
accordance with subsection (b); and
``(3) provide matching funds in accordance with subsection
(f).
``(b) Application.--An application under this subsection shall
include--
``(1) a description of the system that the State has
established, or intends to establish, to ensure the effective
monitoring of prescription drugs from prescribing health care
provider to pharmacy to patient;
``(2) a description of the process by which the State has
established, or intends to establish, the system described in
paragraph (1) that includes the names of the participants, the
timelines for such establishment, and any previous or ongoing
efforts related to the establishment of a statewide system to
reduce the diversion and abuse of prescription drugs;
``(3) a description of the entity that is the designated
State authority to collect and safeguard the information
collected by the monitoring system;
``(4) an estimate, based upon the best available data, of
the extent of prescription drug diversion and abuse in the
State, of any trends relating to such diversion and abuse, of
the types of prescription drugs diverted, and of any local or
regional diversion and abuse patterns that have been detected;
``(5) a description of existing systems in the State used
to track the distribution of prescription drugs, including a
description of how suspected cases of prescription fraud by
health care providers, pharmacies, and patients are
investigated and how data on the outcome of those
investigations is provided to the system;
``(6) a description of the current status of interagency
collaboration among the State's medical and pharmacy oversight
boards, law-enforcement officials, and substance-abuse
authorities that demonstrates a foundation on which the State
can build a collaborative system that fully protects patient
confidentiality;
``(7) a description of the current status of information-
sharing regarding prescribing practices with other States and
of efforts made to improve such information-sharing;
``(8) a description of the existing, or planned,
protections to ensure that the prescription monitoring program
does not restrict access to drugs by legitimate patients;
``(9) a description of the plan of the State for financing
the monitoring system at the conclusion of the 3-year grant
period;
``(10) a description of the source of the State matching
funds required under subsection (e); and
``(11) any other information determined appropriate by the
Secretary.
``(c) Required State Law or Policies.--A State law or policy meets
the requirements of this subsection if such law or policy--
``(1) is developed by a collaborative process that is
conducted by a commission of stakeholders, including
representatives of the public, health care providers,
pharmacists, law enforcement officials, substance-abuse
treatment providers, and others determined appropriate by the
Secretary;
``(2) ensures that the handling of information collected
under the law or policy is used in compliance with the
regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996;
``(3) requires that on a regular basis, each pharmacy in
the State report to the State agency designated under paragraph
(3) information on each prescription filled by the agency,
including--
``(A) the identity of the prescribing health care
provider;
``(B) the identity of the patient;
``(C) the drug prescribed; and
``(D) the amount of drug prescribed;
``(4) ensures that the information provided under paragraph
(3) shall--
``(A) be available, upon request, to the health
care provider and patient involved; and
``(B) be used only in compliance with the
confidentiality guidelines contained in the regulations
promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996;
and
``(5) complies with regulations promulgated by the
Secretary concerning the reporting of information concerning
activities under a grant under this section activities during
the period of the grant and at the conclusion of grant funding.
``(d) Priority.--In awarding grants under this section, the
Secretary shall give priority to those States that have in effect, or
that enact within 1 year of receiving such a grant, a law--
``(1) providing for a prescription-monitoring system that
is based upon the model created by the National Association of
State Controlled Substance Authorities; and
``(2) that requires that Internet pharmacies be licensed in
the State and participate in the monitoring program.
``(e) Use of Funds.--Amounts awarded under a grant under this
section shall be used by the State for the purposes of establishing,
maintaining, and improving a prescription monitoring system, to ensure
the accountability of such system, and to evaluate the performance of
such system.
``(f) Required State Match.--To be eligible to receive a grant
under this section a State shall agree that, with respect to the costs
to be incurred by the State in carrying out the activities for which
the grant was awarded, the State will make available (in cash or in
kind) non-Federal contributions toward such costs in an amount equal
to--
``(1) for the first fiscal year of payments under the
grant, not less than 20 percent of such costs ($2 for each $10
of Federal funds provided in the grant);
``(2) for the second fiscal year of payments under the
grant, not less than 40 percent of such costs ($4 for each $10
of Federal funds provided in the grant); and
``(3) for the third fiscal year of payments under the
grant, not less than 60 percent of such costs ($6 for each $10
of Federal funds provided in the grant).
``SEC. 596C. HEALTH CARE PROVIDER MENTORING GRANTS.
``(a) Purpose.--The purpose of grants awarded under this section is
to assist States in developing and implementing health care provider
education and training programs to increase awareness among providers
of issues pertaining to prescription-drug diversion and abuse by
patients and colleagues.
``(b) Eligibility.--To be eligible for a grant under this section,
a State shall--
``(1) have in effect, or implement within 1 year of
receiving such a grant, a program that meets the requirements
of subsection (d) that provides education and training to
health care providers concerning prescription-drug diversion
and abuse by patients and colleagues;
``(2) prepare and submit to the Secretary an application in
accordance with subsection (c); and
``(3) provide matching funds in accordance with subsection
(g).
``(c) Application.--An application under this subsection shall
include--
``(1) a description of the education and training programs
of the type described in subsection (d) that the State has or
intends to develop;
``(2) a description of the collaborative effort by
individual health care providers and pharmacists, medical,
nursing and pharmacy associations, educational institutions,
the State substance abuse authority, and other relevant
entities to develop the education and training plan;
``(3) a description of the process by which mentors under
the education and training plan will be recruited, selected,
and trained;
``(4) a description of the curriculum developed by the
collaborative effort and of the methods that mentors will use
to deliver it to colleagues, such as one-on-one or group
sessions, seminars, or grand rounds;
``(5) a description of the compensation, if any, that will
be provided to mentors under the plan;
``(6) a description of the collaboration with State
medical, nursing, and pharmacy associations that will result in
the awarding of continuing education units to participants in
activities under the plan;
``(7) a description of the current status of programs,
either conducted by the State or by professional associations,
to educate health care providers on drug-abuse issues;
``(8) a description of the plan of the State for financing
the education and training activities under this section at the
conclusion of the 3-year grant period;
``(9) a description of the source of the State matching
funds required under subsection (f);
``(10) a description of the entity that will administer the
program, which may include the State substance abuse authority,
a State medical, pharmacy or nursing association, an
educational institution, or any other entity deemed appropriate
by the Secretary; and
``(11) any other information determined appropriate by the
Secretary.
``(d) State Education and Training Program.--An education and
training program meets the requirements of this subsection if such
program--
``(1) is designed to provide willing health care providers
and pharmacists with specialized education and training
concerning issues including recognizing drug-seeking behavior
and addiction or dependency among patients and colleagues,
trends in drug abuse, and current research on drug side effects
and interactions;
``(2) is developed through collaboration among substance-
abuse, education, medical, nursing, pharmacy, and other
relevant professionals;
``(3) ensures that information is provided in compliance
with the confidentiality guidelines contained in the
regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996; and
``(4) complies with regulations to be promulgated by the
Secretary of the Department of Health and Human Services
concerning reporting requirements under the program both during
the period of the grant and upon the termination of grant
funding.
``(e) Priority.--In awarding grants under this section, the
Secretary shall give priority to those States that, with respect to
activities under the education and training program under this
section--
``(1) have a collaborative body of stakeholders to review
the operations and effectiveness of the program on an ongoing
basis and to make adjustments to the program as necessary;
``(2) ensure that the pool of mentors includes adequate
representation by health care providers from rural, inner city,
and other at-risk regions; and
``(3) ensure that the mentoring efforts include rural,
inner city, and other at-risk communities.
``(f) Use of Funds.--Amounts awarded under a grant under this
section shall be used by the State for the purposes of establishing and
operating a program to mentor health care providers on issues relating
to prescription drug diversion and abuse, of ensuring its
accountability, and of evaluating its performance.
``(g) Required State Match.--To be eligible to receive a grant
under this section a State shall agree that, with respect to the costs
to be incurred by the State in carrying out the activities for which
the grant was awarded, the State will make available (in cash or in
kind) non-Federal contributions toward such costs in an amount equal
to--
``(1) for the first fiscal year of payments under the
grant, not less than 20 percent of such costs ($2 for each $10
of Federal funds provided in the grant);
``(2) for the second fiscal year of payments under the
grant, not less than 40 percent of such costs ($4 for each $10
of Federal funds provided in the grant); and
``(3) for the third fiscal year of payments under the
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