[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3015 Reported in House (RH)]






                                                 Union Calendar No. 448
108th CONGRESS
  2d Session
                                H. R. 3015

                          [Report No. 108-728]

   To amend the Public Health Service Act to establish an electronic 
 system for practitioner monitoring of the dispensing of any schedule 
      II, III, or IV controlled substance, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 4, 2003

 Mr. Whitfield (for himself and Mr. Pallone) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

                            October 5, 2004

   Additional sponsors: Mrs. Northup, Mr. Sessions, Mr. Stupak, Mrs. 
 Maloney, Mr. Kleczka, Mr. Dicks, Mr. Brown of Ohio, Mr. Pascrell, Mr. 
Lucas of Kentucky, Mr. Green of Texas, Mr. Ramstad, Mr. Jefferson, Mr. 
 Wexler, Mr. Sandlin, Mr. Nethercutt, Mr. Vitter, Mrs. Napolitano, Mr. 
Weldon of Florida, Mr. Kildee, Mr. Souder, Mr. Emanuel, Mr. Blunt, Mr. 
    Fletcher, Ms. DeLauro, Mr. DeMint, Mr. Davis of Illinois, Mrs. 
 Musgrave, Mr. Bachus, Mrs. Bono, Mr. Evans, Mr. Shays, Mrs. Biggert, 
   Mr. Shimkus, Mr. Boozman, Mr. Pickering, Mr. Hall, Mr. Pitts, Ms. 
 Schakowsky, Mrs. Johnson of Connecticut, Mr. Bass, Mr. Ferguson, Mr. 
 Gillmor, Mr. John, Mr. Sullivan, Mr. Forbes, Mr. Wynn, Mr. Rush, Mrs. 
   Christensen, Mr. Deutsch, Mr. Engel, Mr. Terry, Mr. Hoekstra, Mr. 
        Gonzalez, Mr. Chandler, and Mr. Brown of South Carolina

                            October 5, 2004

Reported with amendments, committed to the Committee of the Whole House 
          on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
    [For text of introduced bill, see copy of bill as introduced on 
                           September 4, 2003]

_______________________________________________________________________

                                 A BILL


 
   To amend the Public Health Service Act to establish an electronic 
 system for practitioner monitoring of the dispensing of any schedule 
      II, III, or IV controlled substance, and for other purposes.

    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) Formula Grants.--
            ``(1) In general.--Each fiscal year, the Secretary shall 
        make a payment to each State with an application approved under 
        this section for the purpose of establishing and implementing a 
        controlled substance monitoring program under this section.
            ``(2) Determination of amount.--In making payments under 
        paragraph (1) for a fiscal year, the Secretary shall allocate 
        to each State with an application approved under this section 
        an amount which bears the same ratio to the amount appropriated 
        to carry out this section for that fiscal year 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 paragraph 
        after taking into consideration the budget cost estimate for 
        the State's controlled substance monitoring program.
    ``(b) Application Approval Process.--
            ``(1) In general.--To seek a grant under this section, a 
        State shall submit an application at such time, in such manner, 
        and containing such assurances and information as the Secretary 
        may reasonably require. Each such application shall include--
                    ``(A) a budget cost estimate for the State's 
                controlled substance monitoring program; and
                    ``(B) assurances of compliance with the 
                requirements of this section.
            ``(2) Approval or disapproval.--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. The Secretary shall approve the application if the 
        State demonstrates to the Secretary that the State will 
        establish and implement a controlled substance monitoring 
        program in accordance with this section.
            ``(3) Withdrawal of authorization.--If a State fails to 
        implement a controlled substance monitoring program in 
        accordance with this section--
                    ``(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 payment under this section is that the State 
        involved will give a reasonable period of notice to the 
        Secretary before ceasing to implement 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 a controlled substance monitoring 
        program under this section, a funding agreement for the receipt 
        of a payment under this section is that the State will return 
        to the Secretary an amount which bears the same ratio to the 
        overall payment as the remaining time period for expending the 
        payment bears to the overall time period for expending the 
        payment (as specified by the Secretary at the time of the 
        payment).
    ``(c) Reporting Requirements.--In implementing a controlled 
substance monitoring program under this section, a State shall comply 
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 application 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 application 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.
                    ``(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 specify an electronic format for the 
        reporting of information under this subsection and may waive 
        the requirement of such format with respect to an individual 
        dispenser.
            ``(5) The State shall automatically share information 
        reported under this subsection with another State with an 
        application approved under this section if the information 
        concerns--
                    ``(A) the dispensing of a controlled substance to 
                an ultimate consumer or research subject who resides in 
                such other State; or
                    ``(B) the dispensing of a controlled substance 
                prescribed by a practitioner whose principal place of 
                business is located in such other State.
            ``(6) The State shall notify the appropriate authorities 
        responsible for drug diversion investigation if information in 
        the database maintained by the State under subsection (d) 
        indicates a potential unlawful diversion or misuse of a 
        controlled substance.
    ``(d) Database.--In implementing 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 (c).
            ``(2) The database must be searchable by any field or 
        combination of fields.
            ``(3) The State shall include reported information in the 
        database at such time and in such manner as the Secretary 
        determines appropriate, 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.
    ``(e) Provision of Information.--Subject to subsection (f), in 
implementing a controlled substance monitoring program under this 
section, a State may provide information from the database established 
under subsection (d) and, in the case of a request under paragraph (2) 
or (3), compilations of such information, in response to a request by--
            ``(1) a practitioner (or the agent thereof) who certifies 
        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;
            ``(2) any local, State, or Federal law enforcement, 
        narcotics control, licensure, disciplinary, or program 
        authority, who certifies 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; or
            ``(3) 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.
    ``(f) Limitations.--In implementing 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 (e) to the minimum necessary to accomplish the 
        intended purpose of the request; and
            ``(2) shall not provide any individually identifiable 
        information in response to a request under subsection (e)(3).
    ``(g) 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) No federal private cause of action.--Nothing in this 
        section shall be construed to create a Federal private cause of 
        action.
    ``(h) Relation to HIPAA.--Except to the extent inconsistent with 
this section, the provision of information pursuant to subsection 
(c)(5), (c)(6), or (e) 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.
    ``(i) Preference.--The Secretary, in awarding any competitive grant 
that is related to drug abuse (as determined by the Secretary) to a 
State, shall give preference to any State with an application approved 
under this section.
    ``(j) Study.--Not later than 1 year after the date of the enactment 
of this section, the Secretary shall--
            ``(1) complete a study on--
                    ``(A) the progress of States in establishing and 
                implementing controlled substance monitoring programs 
                under this section; and
                    ``(B) the feasibility of implementing a real-time 
                electronic controlled substance monitoring program, 
                including the costs associated with establishing such a 
                program; and
            ``(2) 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 and implementation 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 State boards of 
        pharmacy, State boards of medicine, 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--
                    ``(A) included in schedule II, III, or IV of 
                section 202(c) of the Controlled Substance Act; or
                    ``(B) identified by the State involved as a drug 
                subject to the monitoring program of the State under 
                this section.
            ``(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 `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.
            ``(6) The term `State' means each of the 50 States and the 
        District of Columbia.
            ``(7) 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.
    ``(m) 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.''.
            Amend the title so as to read: ``A bill to provide for the 
        establishment of a controlled substance monitoring program in 
        each State.''.




                                                 Union Calendar No. 448

108th CONGRESS

  2d Session

                               H. R. 3015

                          [Report No. 108-728]

_______________________________________________________________________

                                 A BILL

   To amend the Public Health Service Act to establish an electronic 
 system for practitioner monitoring of the dispensing of any schedule 
      II, III, or IV controlled substance, and for other purposes.

_______________________________________________________________________

                            October 5, 2004

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