[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.