[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 3013 Introduced in Senate (IS)]







108th CONGRESS
  2d Session
                                S. 3013

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 19, 2004

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

_______________________________________________________________________

                                 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 2004''.

SEC. 2. 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 0.5 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 for a term of 1 year.
    ``(b) Development of Minimum Standards and Recommendations.--
            ``(1) In general.--Not later than 30 days after the date of 
        enactment of this section, the Secretary shall--
                    ``(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
                    ``(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.
            ``(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).
    ``(c) Application Approval Process.--
            ``(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--
                    ``(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) 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;
                            ``(iii) an agreement to adopt, to the 
                        extent practicable, applicable health 
                        information technology standards, as determined 
                        by the Secretary;
                            ``(iv) proposed standards for meeting the 
                        uniform electronic format requirement of 
                        subsection (h);
                            ``(v) proposed standards for availability 
                        of information and limitation on access to 
                        program personnel;
                            ``(vi) proposed standards for access to the 
                        database, and procedures to ensure database 
                        accuracy;
                            ``(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);
                            ``(viii) proposed penalties for the 
                        provision or use of information in violation of 
                        applicable Federal, State, or local 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 standards 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, including--
                                    ``(I) the technical achievement of 
                                information sharing between the two 
                                programs;
                                    ``(II) measures to ensure that 
                                interoperability activities carried out 
                                under this subsection are in compliance 
                                with the requirements of subparagraph 
                                (A);
                                    ``(III) measures to ensure that 
                                proposed standards for information 
                                access will be enforced for shared 
                                information; and
                                    ``(IV) the completion of interstate 
                                legal compacts necessary for such 
                                information sharing; 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) Approval or disapproval.--
                    ``(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.
                    ``(B) Approval.--The Secretary shall approve an 
                application submitted under paragraph (1) only if--
                            ``(i) the plans contained in the 
                        application meet the standards developed by the 
                        Secretary under subsection (b); and
                            ``(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.
                    ``(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.
            ``(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--
                    ``(A) the Secretary shall give notice of the 
                failure to the State; and
                    ``(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.
            ``(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.
            ``(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 or research subject 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 or research 
                subject;
                    ``(B) the dispensing of a controlled substance in a 
                quantity limited to an amount adequate to treat the 
                ultimate user or research subject 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 of the dispenser.
                    ``(B) Drug Enforcement Administration Registration 
                Number and name of the practitioner who prescribed the 
                drug.
                    ``(C) Name, address, and telephone number of the 
                ultimate user or research subject or such contact 
                information of the ultimate user or research subject as 
                the Secretary determines appropriate.
                    ``(D) Identification of the drug by a national drug 
                code number.
                    ``(E) Quantity dispensed.
                    ``(F) Estimated number of days for which such 
                quantity should last.
                    ``(G) Number of refills ordered.
                    ``(H) Whether the drug was dispensed as a refill of 
                a prescription or as a first-time request.
                    ``(I) Date of the dispensing.
                    ``(J) 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.
    ``(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 standards 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) Provision of Information.--
            ``(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--
                    ``(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.--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.
    ``(g) Limitations.--In implementing or improving a controlled 
substance monitoring program under this section, a State--
            ``(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
            ``(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.
    ``(h) Electronic Format.--The Secretary shall specify a uniform 
electronic format for the reporting, sharing, and provision 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 superseding the 
        confidentiality requirements of programs defined by and subject 
        to part 2 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) 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.
    ``(k) Study.--Not later than 2 years after the date of the 
enactment of this section, the Secretary shall--
            ``(1) complete a study that--
                    ``(A) determines the progress of States in 
                establishing and implementing controlled substance 
                monitoring programs under this section;
                    ``(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;
                    ``(C) determines the feasibility of implementing a 
                real-time electronic controlled substance monitoring 
                program, including the costs associated with 
                establishing such a program; and
                    ``(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
                    ``(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
            ``(2) submit a report to the Congress on the results of the 
        study.
    ``(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) 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 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 or research subject 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 individual who dispenses a controlled substance to an 
        ultimate user or research subject.
            ``(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 or research subject 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 is provided in a form and manner that prevents 
        the identification of a provider or patient.
            ``(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 
        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.
    ``(n) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated--
            ``(1) $25,000,000 for each of fiscal years 2006 and 2007; 
        and
            ``(2) $15,000,000 for each of fiscal years 2008, 2009, and 
        2010.''.
                                 <all>