[109th Congress Public Law 60]
[From the U.S. Government Printing Office]


[DOCID: f:publ060.109]

[[Page 119 STAT. 1979]]

Public Law 109-60
109th Congress

                                 An Act


 
 To provide for the establishment of a controlled substance monitoring 
     program in each State. <<NOTE: Aug. 11, 2005 -  [H.R. 1132]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: National All 
Schedules Prescription Electronic Reporting Act of 2005. Health and 
health care. 42 USC 201 note. 42 USC 280g-3 note.>> 

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. <<NOTE: 42 USC 280g-3.>> 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.

[[Page 119 STAT. 1980]]

                    ``(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) <<NOTE: Deadline. Federal Register, publication.>> 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);

[[Page 119 STAT. 1981]]

                          ``(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).

[[Page 119 STAT. 1982]]

    ``(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) <<NOTE: Deadline.>> 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).

[[Page 119 STAT. 1983]]

            ``(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) <<NOTE: Certification.>> 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

[[Page 119 STAT. 1984]]

                    ``(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) <<NOTE: Records.>> 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.

[[Page 119 STAT. 1985]]

                    ``(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) <<NOTE: Effective date.>> 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

[[Page 119 STAT. 1986]]

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.

[[Page 119 STAT. 1987]]

    ``(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.''.

    Approved August 11, 2005.

LEGISLATIVE HISTORY--H.R. 1132 (S. 518):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 109-191 (Comm. on Energy and Commerce).
SENATE REPORTS: No. 109-117 accompanying S. 518 (Comm. on Health, 
Education, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 151 (2005):
            July 27, considered and passed House.
            July 29, considered and passed Senate.

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