[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2288 Introduced in Senate (IS)]







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 
        grant, not less than 60 percent of such costs ($6 for each $10 
        of Federal funds provided in the grant).

``SEC. 596D. PUBLIC EDUCATION GRANTS.

    ``(a) Purpose.--The purpose of grants awarded under this section is 
to assist States in developing and implementing programs to increase 
public awareness of the problem of prescription-drug diversion and 
abuse.
    ``(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) and that provides public education relating 
        to prescription drug diversion and abuse and the potential for 
        addiction, dependency, and undesirable health outcomes;
            ``(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 program that the State 
        is implementing, or intends to implement, to increase public 
        awareness of the problems associated with prescription drug 
        diversion and abuse, including information on the various 
        population groups that are or will be targeted under the 
        program and the educational methods that are or will be 
        employed for each such population group;
            ``(2) a description of the current status of prescription 
        drug diversion and abuse in the state and current efforts to 
        curtail it;
            ``(3) a description of the methods by which the 
        effectiveness of the program under this section will be 
        measured;
            ``(4) a description of the State agency or non-profit 
        organization that will administer the program funded under this 
        section;
            ``(5) a description of the collaborative effort that was 
        used to develop the program;
            ``(6) a description of the plan of the State for financing 
        the program under this section at the conclusion of the 3-year 
        grant period;
            ``(7) a description of the source of the State matching 
        funds required under subsection (f); and
            ``(8) any other information determined appropriate by the 
        Secretary.
    ``(d) State Public Education Program.--A public education program 
meets the requirements of this subsection if such program is developed 
through collaboration among substance-abuse authorities, law-
enforcement, education, and health care entities, members of the 
public, and other relevant entities;
    ``(e) Priority.--In awarding grants under this section, the 
Secretary shall give priority to those States that, with respect to 
activities under the program under this section--
            ``(1) have a collaborative body of stakeholders to review 
        the operations and effectiveness of the program on an on-going 
        basis and to make adjustments to the program as necessary; and
            ``(2) ensure that the educational 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 increase public awareness of the problem of 
prescription drug diversion and abuse.
    ``(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 
        grant, not less than 60 percent of such costs ($6 for each $10 
        of Federal funds provided in the grant).

``SEC. 596E. REGULATIONS AND EVALUATION.

    ``(a) Regulations.--The Secretary is authorized to promulgate 
regulations as determined necessary to carry out the purposes of the 
part.
    ``(b) Evaluation.--Not later than 2 years after the date of 
enactment of this part, the General Accounting Office shall conduct a 
study and submit a report to Congress concerning how the States have 
used the amounts provided under this part and whether such activities 
have been effective in reducing the diversion and abuse of prescription 
drugs.

``SEC. 596F. AUTHORIZATION OF APPROPRIATIONS.

    ``There is authorized to be appropriated to carry out this part, 
$20,000,000 for each of fiscal years 2005 through 2007.''.
                                 <all>