[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 518 Reported in Senate (RS)]


                                                       Calendar No. 187
109th CONGRESS
  1st Session
                                 S. 518

                          [Report No. 109-117]

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 3, 2005

  Mr. Sessions (for himself, Mr. Durbin, Mr. Kennedy,  Mr. Dodd, Mr. 
    Alexander, Mr. Vitter, Mr. Burr, and Mr. Talent) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

                             July 29, 2005

                Reported by Mr. Enzi, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``National All Schedules 
Prescription Electronic Reporting Act of 2005''.</DELETED>

<DELETED>SEC. 2. CONTROLLED SUBSTANCE MONITORING PROGRAM.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 399O. CONTROLLED SUBSTANCE MONITORING 
              PROGRAM.</DELETED>

<DELETED>    ``(a) Grants.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) to establish and implement a State 
                controlled substance monitoring program; or</DELETED>
                <DELETED>    ``(B) to make improvements to an existing 
                State controlled substance monitoring 
                program.</DELETED>
        <DELETED>    ``(2) Determination of amount.--</DELETED>
                <DELETED>    ``(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 0.5 percent of the amount appropriated to carry 
                out this section for that fiscal year.</DELETED>
                <DELETED>    ``(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 paragraph (1) 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.</DELETED>
        <DELETED>    ``(3) Term of certain grants.--Grants awarded 
        under this section shall be for a term of 18 months.</DELETED>
<DELETED>    ``(b) Development of Minimum Standards and 
Recommendations.--</DELETED>
        <DELETED>    ``(1) In general.--Not later than 30 days after 
        the date of enactment of this section, the Secretary shall--
        </DELETED>
                <DELETED>    ``(A) develop minimum standards for use by 
                States in submitting their proposed standards under 
                clauses (ii), (v), (vi), and (vii) of subsection 
                (c)(1)(A); and</DELETED>
                <DELETED>    ``(B) develop recommendations with respect 
                to appropriate penalties for the provision or use of 
                information in violation of applicable Federal, State, 
                or local law or regulation.</DELETED>
        <DELETED>    ``(2) Report.--Not later than 1 year after the 
        date of enactment of this section, the Secretary shall report 
        to Congress on the recommendations developed under paragraph 
        (1)(B) and the extent to which existing penalties meet, exceed, 
        or fall short of such recommendations.</DELETED>
<DELETED>    ``(c) Application Approval Process.--</DELETED>
        <DELETED>    ``(1) In general.--To be eligible to receive a 
        grant under this section, a State shall submit, and have 
        approved in accordance with paragraph (2), 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--</DELETED>
                <DELETED>    ``(A) with respect to a State that intends 
                to use funds under the grant as provided for in 
                subsection (a)(1)(A)--</DELETED>
                        <DELETED>    ``(i) a budget cost estimate for 
                        the controlled substance monitoring program to 
                        be implemented under the grant;</DELETED>
                        <DELETED>    ``(ii) proposed standards 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;</DELETED>
                        <DELETED>    ``(iii) an agreement to adopt, to 
                        the extent practicable, applicable health 
                        information technology standards, as determined 
                        by the Secretary;</DELETED>
                        <DELETED>    ``(iv) proposed standards for 
                        meeting the uniform electronic format 
                        requirement of subsection (h);</DELETED>
                        <DELETED>    ``(v) proposed standards for 
                        availability of information and limitation on 
                        access to program personnel;</DELETED>
                        <DELETED>    ``(vi) proposed standards for 
                        access to the database, and procedures to 
                        ensure database accuracy;</DELETED>
                        <DELETED>    ``(vii) proposed standards for the 
                        provision of information, including a 
                        description of the certification process to be 
                        applied to requests for information under 
                        subsection (f);</DELETED>
                        <DELETED>    ``(viii) proposed penalties for 
                        the provision or use of information in 
                        violation of applicable Federal, State, or 
                        local law or regulation; and</DELETED>
                        <DELETED>    ``(ix) assurances of compliance 
                        with all other requirements of this section; 
                        or</DELETED>
                <DELETED>    ``(B) with respect to a State that intends 
                to use funds under the grant as provided for in 
                subsection (a)(1)(B)--</DELETED>
                        <DELETED>    ``(i) a budget cost estimate for 
                        the controlled substance monitoring program to 
                        be improved under the grant;</DELETED>
                        <DELETED>    ``(ii) a plan for ensuring that 
                        the State controlled substance monitoring 
                        program is in compliance with the standards and 
                        penalty requirements described in clauses (ii) 
                        through (viii) of subparagraph (A);</DELETED>
                        <DELETED>    ``(iii) a plan to enable the State 
                        controlled substance monitoring program to 
                        achieve interoperability with at least one 
                        other State controlled substance monitoring 
                        program, including--</DELETED>
                                <DELETED>    ``(I) the technical 
                                achievement of information sharing 
                                between the two programs;</DELETED>
                                <DELETED>    ``(II) measures to ensure 
                                that interoperability activities 
                                carried out under this subsection are 
                                in compliance with the requirements of 
                                subparagraph (A);</DELETED>
                                <DELETED>    ``(III) measures to ensure 
                                that proposed standards for information 
                                access will be enforced for shared 
                                information; and</DELETED>
                                <DELETED>    ``(IV) the completion of 
                                interstate legal compacts necessary for 
                                such information sharing; and</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Approval or disapproval.--</DELETED>
                <DELETED>    ``(A) In general.--Not later than 90 days 
                after the submission by a State of an application under 
                paragraph (1), the Secretary shall approve or 
                disapprove the application, or request additional 
                information as provided under subparagraph (C). The 
                Secretary may disapprove an application that contains a 
                statement described in paragraph (1)(B)(iv), or request 
                additional information with respect to such a 
                statement, if the Secretary determines that the 
                approval of such application would result in the 
                implementation of a State program that substantially 
                fails to meet the goals and objectives of this 
                section.</DELETED>
                <DELETED>    ``(B) Approval.--The Secretary shall 
                approve an application submitted under paragraph (1) 
                only if--</DELETED>
                        <DELETED>    ``(i) the plans contained in the 
                        application meet the standards developed by the 
                        Secretary under subsection (b); and</DELETED>
                        <DELETED>    ``(ii) the State demonstrates to 
                        the Secretary that the State will establish and 
                        implement or improve a controlled substance 
                        monitoring program in accordance with this 
                        section.</DELETED>
                <DELETED>    ``(C) Additional information.--With 
                respect to an application submitted by a State under 
                paragraph (1), the Secretary may, during the 90-day 
                period referred to in subparagraph (A), request that 
                the State provide additional information with respect 
                to the State program. If such a request is made after 
                the expiration of the 60-day period beginning on the 
                date on which the application is submitted, the period 
                under subparagraph (A) for approval or disapproval by 
                the Secretary shall be extended for an additional 30 
                days.</DELETED>
        <DELETED>    ``(3) Withdrawal of authorization.--Except to the 
        extent that a State is excused from compliance with a 
        requirement or standard as a result of the approval by the 
        Secretary of a statement under paragraph (1)(B)(iv) or under 
        subsection (d), if a State fails to implement or improve a 
        controlled substance monitoring program in accordance with this 
        section or fails to comply with the standards developed under 
        this subsection--</DELETED>
                <DELETED>    ``(A) the Secretary shall give notice of 
                the failure to the State; and</DELETED>
                <DELETED>    ``(B) if the State fails to take 
                corrective action within a reasonable period of time, 
                the Secretary shall withdraw any approval of the 
                State's application under this section.</DELETED>
        <DELETED>    ``(4) Voluntary discontinuance.--A funding 
        agreement for the receipt of a grant under this section is that 
        the State involved will give a reasonable period of notice to 
        the Secretary before ceasing to implement or operate a 
        controlled substance monitoring program under this section. The 
        Secretary shall determine the period of notice that is 
        reasonable for purposes of this paragraph.</DELETED>
        <DELETED>    ``(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).</DELETED>
<DELETED>    ``(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:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) The State may exclude from the reporting 
        requirement of this subsection--</DELETED>
                <DELETED>    ``(A) the direct administration of a 
                controlled substance to the body of an ultimate 
                user;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(C) the administration or dispensing of 
                a controlled substance in accordance with any other 
                exclusion identified by the Secretary for purposes of 
                this paragraph.</DELETED>
        <DELETED>    ``(3) The information to be reported under this 
        subsection with respect to the dispensing of a controlled 
        substance shall include the following:</DELETED>
                <DELETED>    ``(A) Drug Enforcement Administration 
                Registration Number of the dispenser.</DELETED>
                <DELETED>    ``(B) Drug Enforcement Administration 
                Registration Number and name of the practitioner who 
                prescribed the drug.</DELETED>
                <DELETED>    ``(C) Name, address, and telephone number 
                of the ultimate user or such contact information of the 
                ultimate user as the Secretary determines 
                appropriate.</DELETED>
                <DELETED>    ``(D) Identification of the drug by a 
                national drug code number.</DELETED>
                <DELETED>    ``(E) Quantity dispensed.</DELETED>
                <DELETED>    ``(F) Estimated number of days for which 
                such quantity should last.</DELETED>
                <DELETED>    ``(G) Number of refills ordered.</DELETED>
                <DELETED>    ``(H) Whether the drug was dispensed as a 
                refill of a prescription or as a first-time 
                request.</DELETED>
                <DELETED>    ``(I) Date of the dispensing.</DELETED>
                <DELETED>    ``(J) Date of origin of the 
                prescription.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(e) Database.--In implementing or improving a controlled 
substance monitoring program under this section, a State shall comply 
with the following:</DELETED>
        <DELETED>    ``(1) The State shall establish and maintain an 
        electronic database containing the information reported to the 
        State under subsection (d).</DELETED>
        <DELETED>    ``(2) The database must be searchable by any field 
        or combination of fields.</DELETED>
        <DELETED>    ``(3) The State shall include reported information 
        in the database in a manner consistent with standards 
        established by the Secretary, with appropriate safeguards for 
        ensuring the accuracy and completeness of the 
        database.</DELETED>
        <DELETED>    ``(4) The State shall take appropriate security 
        measures to protect the integrity of, and access to, the 
        database.</DELETED>
<DELETED>    ``(f) Provision of Information.--</DELETED>
        <DELETED>    ``(1) In general.--Subject to subsection (g), in 
        implementing or improving a controlled substance monitoring 
        program under this section, a State may provide information 
        from the database established under subsection (e) and, in the 
        case of a request under paragraph (3), summary statistics of 
        such information, in response to a request by--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(C) the controlled substance monitoring 
                program of another State or group of States with whom 
                the State has established an interoperability 
                agreement;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) the State has an application 
                        approved under this section; and</DELETED>
                        <DELETED>    ``(ii) the requested information 
                        is for the purpose of implementing the State's 
                        controlled substance monitoring program under 
                        this section.</DELETED>
        <DELETED>    ``(2) Drug diversion.--A State that elects to 
        exercise its authority to notify the appropriate authorities 
        responsible for drug diversion investigations if information in 
        the database maintained by the State under subsection (e) is 
        suggestive of an unlawful diversion or misuse of a controlled 
        substance, is encouraged to develop any such notification 
        program in consultation with representatives of the medical 
        community, including physicians and pharmacists or other 
        interested stakeholders.</DELETED>
<DELETED>    ``(g) Limitations.--In implementing or improving a 
controlled substance monitoring program under this section, a State--
</DELETED>
        <DELETED>    ``(1) shall make reasonable efforts to 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</DELETED>
        <DELETED>    ``(2) shall limit information provided in response 
        to a request under subsection (f)(1)(D) to information provided 
        in a form and manner that prevents the identification of a 
        provider or patient.</DELETED>
<DELETED>    ``(h) Electronic Format.--The Secretary shall specify a 
uniform electronic format for the reporting, sharing, and provision of 
information under this section.</DELETED>
<DELETED>    ``(i) Rules of Construction.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Additional privacy protections.--Nothing in 
        this section shall be construed as preempting any State from 
        imposing any additional privacy protections.</DELETED>
        <DELETED>    ``(4) Certain confidentiality requirements.--
        Nothing in this section shall be construed as superseding the 
        confidentiality requirements of programs defined by and subject 
        to part 2 of title 42, Code of Federal Regulations.</DELETED>
        <DELETED>    ``(5) No federal private cause of action.--Nothing 
        in this section shall be construed to create a Federal private 
        cause of action.</DELETED>
<DELETED>    ``(j) Relation to HIPAA.--Except to the extent 
inconsistent with this section, the provision of information pursuant 
to subsection (f) and the subsequent transfer of such information are 
subject to any requirement that would otherwise apply under the 
regulations promulgated pursuant to section 264(c) of the Health 
Insurance Portability and Accountability Act of 1996.</DELETED>
<DELETED>    ``(k) Study.--Not later than 2 years after the date of the 
enactment of this section, the Secretary shall--</DELETED>
        <DELETED>    ``(1) complete a study that--</DELETED>
                <DELETED>    ``(A) determines the progress of States in 
                establishing and implementing controlled substance 
                monitoring programs under this section;</DELETED>
                <DELETED>    ``(B) 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;</DELETED>
                <DELETED>    ``(C) determines the feasibility of 
                implementing a real-time electronic controlled 
                substance monitoring program, including the costs 
                associated with establishing such a program; 
                and</DELETED>
                <DELETED>    ``(D) 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 a comparison to the 
                privacy requirements that apply to covered entities 
                under regulations promulgated pursuant to section 
                264(c) of the Health Insurance Portability and 
                Accountability Act of 1996, along with any 
                recommendations for additional requirements for 
                protection of this information; and</DELETED>
                <DELETED>    ``(E) 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</DELETED>
        <DELETED>    ``(2) submit a report to the Congress on the 
        results of the study.</DELETED>
<DELETED>    ``(l) Advisory Council.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) 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.</DELETED>
<DELETED>    ``(m) Definitions.--For purposes of this 
section:</DELETED>
        <DELETED>    ``(1) The term `bona fide patient' means an 
        individual who is a patient of the dispenser or practitioner 
        involved.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(4) The term `dispenser' means a physician, 
        pharmacist, or other individual who dispenses a controlled 
        substance to an ultimate user.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(6) The term `nonidentifiable information' means 
        information that is provided in a form and manner that prevents 
        the identification of a provider or patient.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(8) The term `State' means each of the 50 States 
        and the District of Columbia.</DELETED>
        <DELETED>    ``(9) The term `ultimate user' means a person who 
        has lawfully obtained, 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.</DELETED>
<DELETED>    ``(n) Authorization of Appropriations.--To carry out this 
section, there are authorized to be appropriated--</DELETED>
        <DELETED>    ``(1) $25,000,000 for each of fiscal years 2006 
        and 2007; and</DELETED>
        <DELETED>    ``(2) $15,000,000 for each of fiscal years 2008, 
        2009, and 2010.''.</DELETED>

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 
        prescription drug 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 
        control 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 paragraph (1) 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 certain 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, but not later than 6 months after the date on 
which funds are first appropriated under this section, the Secretary 
shall identify minimum requirements for use by States in submitting 
their proposed criteria under 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 database accuracy;
                            ``(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 in violation of 
                        applicable State law or regulation; and
                            ``(ix) 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 the State to have 
        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 substances 
        monitoring program under subsection (a)(1) on the date 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) 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.
            ``(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 subsection (f)(1)(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) Certain confidentiality requirements.--Nothing in 
        this section shall be construed as preempting the 
        confidentiality requirements of part 2 and part 2a of title 42, 
        Code of Federal Regulations.
            ``(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) 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;
                            ``(iii) determines the feasibility of 
                        implementing a real-time electronic controlled 
                        substance monitoring program, including the 
                        costs associated with establishing such a 
                        program;
                            ``(iv) 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;
                            ``(v) 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
                            ``(vi) 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) 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.
    ``(l) Definitions.--For purposes of this section:
            ``(1) The term `bona fide patient' means an individual who 
        is a patient of the dispenser or 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 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 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.
    ``(m) 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.''.
                                                       Calendar No. 187

109th CONGRESS

  1st Session

                                 S. 518

                          [Report No. 109-117]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             July 29, 2005

                       Reported with an amendment