[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1132 Reported in House (RH)]







                                                 Union Calendar No. 115
109th CONGRESS
  1st Session
                                H. R. 1132

                          [Report No. 109-191]

 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

                             July 27, 2005

     Additional sponsors: Mr. Gonzalez, Mr. Jindal, Mr. Wynn, Mrs. 
 Christensen, Mr. Rush, Mr. Kildee, Mr. Blunt, Mr. Shimkus, Mr. Dicks, 
 Mr. Bachus, Mr. Chandler, Mr. Stupak, Mr. Pickering, Mr. Shays, Mrs. 
 Bono, Mr. Alexander, Mr. Hall, Mr. Pascrell, Mr. Wexler, Ms. DeLauro, 
  Ms. Jackson-Lee of Texas, Mr. Rogers of Michigan, Mrs. Northup, Mr. 
Ferguson, Mr. Brown of Ohio, Mr. Emanuel, Ms. Eshoo, Mr. Bilirakis, Mr. 
                    Engel, Mr. Souder, and Mr. Terry

                             July 27, 2005

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
 [For text of introduced bill, see copy of bill as introduced on March 
                                3, 2005]

_______________________________________________________________________

                                 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. 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, 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.''.
                                                 Union Calendar No. 115

109th CONGRESS

  1st Session

                               H. R. 1132

                          [Report No. 109-191]

_______________________________________________________________________

                                 A BILL

 To provide for the establishment of a controlled substance monitoring 
                         program in each State.

_______________________________________________________________________

                             July 27, 2005

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed