```

[House Report 114-245]
[From the U.S. Government Publishing Office]

114th Congress    }                                      {      Report
                        HOUSE OF REPRESENTATIVES
 1st Session      }                                      {     114-245

======================================================================

 
       NATIONAL ALL SCHEDULES PRESCRIPTION ELECTRONIC REPORTING 
                      REAUTHORIZATION ACT OF 2015

                                _______
                                

 September 8, 2015.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 1725]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1725) to amend and reauthorize the controlled 
substance monitoring program under section 399O of the Public 
Health Service Act, and for other purposes, having considered 
the same, report favorably thereon without amendment and 
recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     2
Committee Consideration..........................................     2
Committee Votes..................................................     2
Committee Oversight Findings.....................................     3
Statement of General Performance Goals and Objectives............     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     3
Committee Cost Estimate..........................................     3
Congressional Budget Office Estimate.............................     3
Federal Mandates Statement.......................................     5
Duplication of Federal Programs..................................     5
Disclosure of Directed Rule Makings..............................     5
Advisory Committee Statement.....................................     5
Applicability to Legislative Branch..............................     5
Section-by-Section Analysis of the Legislation...................     5
Changes in Existing Law Made by the Bill, as Reported............     6

                          Purpose and Summary

    H.R. 1725, National All Schedules Prescription Electronic 
Reporting Reauthorization Act of 2015, was introduced on March 
26, 2015, by Rep. Whitfield (R-KY), Rep. Kennedy (D-MA), Rep. 
Pallone (D-NJ) and Rep. Bucshon (R-IN), to amend and 
reauthorize the controlled substance monitoring program under 
section 399O of the Public Services Act, and for other 
purposes.

                  Background and Need for Legislation

    Almost ten years ago, the National All Schedules 
Prescription Electronic Reporting Act (NASPER) was signed into 
law to assist States in combating prescription drug abuse 
through the creation and improvement of prescription drug 
monitoring programs (PDMPs), which are one of the most 
promising clinical tools to address the prescription drug abuse 
epidemic.
    H.R. 1725 would reauthorize NASPER and provide States the 
necessary resources to build upon the success PDMPs have had in 
reducing prescription drug abuse by streamlining access to 
timely, accurate, and secure patient prescription history. The 
bill also would promote interstate interoperability and 
encourage integration between PDMPs and point of service 
physician tools such as electronic health records.

                                Hearings

    The Subcommittee on Health held a hearing on H.R. 1725 on 
Tuesday, January 27, 2015. The Subcommittee received testimony 
from:
           Ben D. Chlapek, Deputy Chief Central Jackson 
        Fire;
           John L. Eadie, Director, Prescription Drug 
        Monitoring Program Center of Excellence, Brandeis 
        University;
           Blain L. Enderson, MD, Department of 
        Surgery, University of Tennessee Medical Center;
           Nathan B. Fountain, MD, Professor of 
        Neurology, Director of F.E. Dreifuss Comprehensive 
        Epilepsy Program; and,
           D. Linden Barber, Partner and Director, DEA 
        Compliance Operations, Quarles & Brady.

                        Committee Consideration

    On Thursday, July 23, 2015, the Subcommittee on Health met 
in open markup session and forwarded H.R. 1725 to the full 
Committee, without amendment, by a voice vote. On Wednesday, 
July 29, 2015, the full Committee on Energy and Commerce met in 
open markup session and ordered H.R. 1725 reported to the 
House, without amendment, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 1725 reported. A motion by Mr. Upton to order H.R. 1725 
reported to the House, without amendment, was agreed to by a 
voice vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held hearings 
on this legislation.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(1) of rule XIII of the House of 
Representatives, the goal of the legislation is to reauthorize 
the controlled substance monitoring program under section 399O 
of the Public Health Service Act, and for other purposes.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
1725, would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 1725 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                   Washington, DC, August 14, 2015.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1725, the National 
All Schedules Prescription Electronic Reporting Reauthorization 
Act of 2015.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Ellen Werble.
            Sincerely,
                                                        Keith Hall.
    Enclosure.

H.R. 1725--National All Schedules Prescription Electronic Reporting 
        Reauthorization Act of 2015

    Summary: H.R. 1725 would reauthorize funding for grants to 
states and territories to establish, improve, or maintain an 
electronic database system for monitoring the dispensing of 
controlled substances. Under current law, most states operate 
such systems and receive funding from a variety of sources to 
maintain or improve those systems. The bill also would require 
the Secretary of Health and Human Services to monitor the 
states' efforts to achieve interoperability of the database 
systems for the purpose of sharing information with bordering 
states and with other systems such as those for electronic 
health records.
    The bill would authorize the appropriation of $10 million a 
year for fiscal years 2016 through 2020. Assuming appropriation 
of those amounts, CBO estimates that implementing H.R. 1725 
would cost $43 million over the 2016-2020 period. Enacting H.R. 
1725 would not affect direct spending or revenues; therefore, 
pay-as-you-go procedures do not apply.
    H.R. 1725 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
    Estimated cost to the Federal Government: The estimated 
budgetary effects of H.R. 1725 are shown in the following 
table. The costs of this legislation fall within budget 
function 550 (health).

----------------------------------------------------------------------------------------------------------------
                                                                 By fiscal year, in millions of dollars--
                                                         -------------------------------------------------------
                                                            2016     2017     2018     2019     2020   2016-2020
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION
 
Authorization Level.....................................       10       10       10       10       10        50
Estimated Outlays.......................................        4        9       10       10       10        43
----------------------------------------------------------------------------------------------------------------

    Basis of estimate: For this estimate, CBO assumes that H.R. 
1725 will be enacted near the start of fiscal year 2016, that 
the Congress will appropriate the authorized amounts for each 
year, and that spending will follow historical patterns for the 
authorized program.
    Pay-As-You-Go considerations: None.
    Intergovernmental and private-sector impact: H.R. 1725 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would impose no costs on state, local, or 
tribal governments. The bill would authorize funding for grants 
to states to monitor the distribution of controlled substances 
and to notify authorities when they suspect that controlled 
substances are being imported, dispensed, or used. Any costs 
incurred for complying with those conditions for receiving 
federal funds would be incurred voluntarily.
    Estimate prepared by: Federal costs: Ellen Werble; Impact 
on state, local, and tribal governments: J'nell Blanco Suchy; 
Impact on the private sector: Amy Petz.
    Estimate approved by: Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 1725 would establish nor reauthorize a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 1725 
specifically directs to be completed 0 rule makings within the 
meaning of 5 U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

Section 1. Short title

    Section 1 states the legislation may be cited as the 
``National All Schedules Prescription Electronic Reporting 
Reauthorization Act of 2015.''

Section 2. Amendment to purpose

    Section 2 would ensure health care providers have access to 
accurate, timely prescription history information that may be 
useful in identifying patients at risk for addiction and to 
ensure appropriate law enforcement and regulatory and 
professional licensing authorities have access to prescription 
history information for the purposes of investigating drug 
diversion and prescribing and dispensing practices of errant 
prescribers or pharmacists.

Section 3. Amendments to controlled substance monitoring program

    Section 3 would amend section 399O of the Public Health 
Service Act by asking the Secretary to award grants to States 
to maintain and operate an existing State-controlled substance 
monitoring program. This section also would revise subsections 
focusing on the development of minimum requirements for grants, 
interoperability, return of funds, evaluation and reporting, 
education, and access.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, and existing law in which no 
change is proposed is shown in roman):

  NATIONAL ALL SCHEDULES PRESCRIPTION ELECTRONIC REPORTING ACT OF 2005

           *       *       *       *       *       *       *
SEC. 2. PURPOSE.

  It is the purpose of this Act to--
          [(1) foster the establishment of State-administered 
        controlled substance monitoring systems in order to 
        ensure that health care providers have access to the 
        accurate, timely prescription history information that 
        they may use as a tool for the early identification of 
        patients at risk for addiction in order to initiate 
        appropriate medical interventions and avert the tragic 
        personal, family, and community consequences of 
        untreated addiction; and]
          (1) foster the establishment of State-administered 
        controlled substance monitoring systems in order to 
        ensure that--
                  (A) 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
                  (B) appropriate law enforcement, regulatory, 
                and State professional licensing authorities 
                have access to prescription history information 
                for the purposes of investigating drug 
                diversion and prescribing and dispensing 
                practices of errant prescribers or pharmacists; 
                and
          (2) establish, based on the experiences of existing 
        State controlled substance monitoring programs, a set 
        of best practices to guide the establishment of new 
        State programs and the improvement of existing 
        programs.

           *       *       *       *       *       *       *

                              ----------                              

                       PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *

PART P--ADDITIONAL PROGRAMS

           *       *       *       *       *       *       *

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[.]; or
                  (C) to maintain and operate an existing 
                State-controlled substance monitoring program.
          (2) Determination of amount.--
                  (A) Minimum amount.--In making payments under 
                a grant under paragraph (1) for a fiscal year, 
                the Secretary shall allocate to each State with 
                an application approved under this section an 
                amount that equals 1.0 percent of the amount 
                appropriated to carry out this section for that 
                fiscal year.
                  (B) Additional amounts.--In making payments 
                under a grant under paragraph (1) for a fiscal 
                year, the Secretary shall allocate to each 
                State with an application approved under this 
                section an additional amount which bears the 
                same ratio to the amount appropriated to carry 
                out this section for that fiscal year and 
                remaining after amounts are made available 
                under subparagraph (A) as the number of 
                pharmacies of the State bears to the number of 
                pharmacies of all States with applications 
                approved under this section (as determined by 
                the Secretary), except that the Secretary may 
                adjust the amount allocated to a State under 
                this subparagraph after taking into 
                consideration the budget cost estimate for the 
                State's controlled substance monitoring 
                program.
          (3) Term of grants.--Grants awarded by the Secretary 
        under this section shall be obligated in the year in 
        which funds are allotted.
  [(b) Development of Minimum Requirements.--Prior to awarding 
a grant under this section, and not later than 6 months after 
the date on which funds are first appropriated to carry out 
this section, after seeking consultation with States and other 
interested parties, the Secretary shall, after publishing in 
the Federal Register proposed minimum requirements and 
receiving public comments, establish minimum requirements for 
criteria to be used by States for purposes of clauses (ii), 
(v), (vi), and (vii) of subsection (c)(1)(A).]
  (b) Minimum Requirements.--The Secretary shall maintain and, 
as appropriate, supplement or revise (after publishing proposed 
additions and revisions in the Federal Register and receiving 
public comments thereon) minimum requirements for criteria to 
be used by States for purposes of clauses (ii), (v), (vi), and 
(vii) of subsection (c)(1)(A).
  (c) Application Approval Process.--
          (1) In general.--To be eligible to receive a grant 
        under this section, a State shall submit an application 
        to the Secretary at such time, in such manner, and 
        containing such assurances and information as the 
        Secretary may reasonably require. Each such application 
        shall include--
                  (A) with respect to a State that intends to 
                use funds under the grant as provided for in 
                subsection (a)(1)(A)--
                          (i) a budget cost estimate for the 
                        controlled substance monitoring program 
                        to be implemented under the grant;
                          (ii) criteria for security for 
                        information handling and for the 
                        database maintained by the State under 
                        subsection (e) generally including 
                        efforts to use appropriate encryption 
                        technology or other appropriate 
                        technology to protect the security of 
                        such information;
                          (iii) an agreement to adopt health 
                        information interoperability standards, 
                        including health vocabulary and 
                        messaging standards, that are 
                        consistent with any such standards 
                        generated or identified by the 
                        Secretary or his or her designee;
                          (iv) criteria for meeting the uniform 
                        electronic format requirement of 
                        [subsection (h)] subsection (j) ;
                          (v) criteria for availability of 
                        information and limitation on access to 
                        program personnel;
                          (vi) criteria for access to the 
                        database, and procedures to ensure that 
                        information in the database is 
                        accurate;
                          (vii) criteria for the use and 
                        disclosure of information, including a 
                        description of the certification 
                        process to be applied to requests for 
                        information under subsection (f);
                          (viii) penalties for the unauthorized 
                        use and disclosure of information 
                        maintained in the State controlled 
                        substance monitoring program in 
                        violation of applicable State law or 
                        regulation;
                          (ix) information on the relevant 
                        State laws, policies, and procedures, 
                        if any, regarding purging of 
                        information from the database; and
                          (x) assurances of compliance with all 
                        other requirements of this section; or
                  (B) with respect to a State that intends to 
                use funds under the grant as provided for in 
                subsection [(a)(1)(B)] (a)(1)(B)  or (a)(1)(C) 
                --
                          (i) a budget cost estimate for the 
                        controlled substance monitoring 
                        [program to be improved] program to be 
                        improved or maintained 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 apply the latest 
                        advances in health information 
                        technology in order to incorporate 
                        prescription drug monitoring program 
                        data directly into the workflow of 
                        prescribers and dispensers to ensure 
                        timely access to patients' controlled 
                        prescription drug history;
                          [(iii)] (iv) a plan to enable the 
                        State controlled substance monitoring 
                        program to achieve interoperability 
                        with at least one other State 
                        controlled substance monitoring program 
                        and at least one health information 
                        technology system such as an electronic 
                        health records system, a health 
                        information exchange, or an e-
                        prescribing system ; and
                          [(iv)] (v) 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] public health or public 
                        safety in such State.
          (2) State legislation.--As part of an application 
        under paragraph (1), the Secretary shall require a 
        State to demonstrate that the State has enacted 
        legislation or regulations to permit the implementation 
        of the State controlled substance monitoring program 
        and the imposition of appropriate penalties for the 
        unauthorized use and disclosure of information 
        maintained in such program.
          (3) Interoperability.--[If a State that submits]
                  (A) In general._If a State that submits an 
                application under this subsection 
                geographically borders another State that is 
                operating a controlled substance monitoring 
                program under subsection (a)(1) on the date of 
                submission of such application, and such 
                applicant State has not achieved 
                interoperability for purposes of information 
                sharing between its monitoring program and the 
                monitoring program of such border State, such 
                applicant State shall, as part of the plan 
                under paragraph (1)(B)(iii), describe the 
                manner in which the applicant State will 
                achieve interoperability between the monitoring 
                programs of such States[.] and include 
                timelines for full implementation of such 
                interoperability. The State shall also describe 
                the manner in which it will achieve 
                interoperability between its monitoring program 
                and health information technology systems, as 
                allowable under State law, and include 
                timelines for implementation of such 
                interoperability.
                  (B) Monitoring of efforts.--The Secretary 
                shall monitor State efforts to achieve 
                interoperability, as described in subparagraph 
                (A).
          (4) Approval.--If a State submits an application in 
        accordance with this subsection, the Secretary shall 
        approve such application.
          (5) Return of funds.--If the Secretary withdraws 
        approval of a State's application under this section, 
        or the State chooses to cease to [implement or improve] 
        establish, improve, or maintain 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). The Secretary shall redistribute any funds 
        that are so returned among the remaining grantees under 
        this section in accordance with the formula described 
        in subsection (a)(2)(B).
  (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)] In establishing, improving, 
or maintaining a controlled substance monitoring program under 
this section, a State shall comply, or with respect to a State 
that applies for a grant under subparagraph (B) or (C) of 
subsection (a)(1) 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] public health or 
public safety in such State, with the following:
          (1) The State shall require dispensers to report to 
        such State each dispensing in the State of a controlled 
        substance to an ultimate user not later than 1 week 
        after the date of such dispensing.
          (2) The State may exclude from the reporting 
        requirement of this subsection--
                  (A) the direct administration of a controlled 
                substance to the body of an ultimate user;
                  (B) the dispensing of a controlled substance 
                in a quantity limited to an amount adequate to 
                treat the ultimate user involved for 48 hours 
                or less; or
                  (C) the administration or dispensing of a 
                controlled substance in accordance with any 
                other exclusion identified by the Secretary for 
                purposes of this paragraph.
          (3) The information to be reported under this 
        subsection with respect to the dispensing of a 
        controlled substance shall include the following:
                  (A) Drug Enforcement Administration 
                Registration Number (or other identifying 
                number used in lieu of such Registration 
                Number) of the dispenser.
                  (B) Drug Enforcement Administration 
                Registration Number (or other identifying 
                number used in lieu of such Registration 
                Number) and name of the practitioner who 
                prescribed the drug.
                  (C) Name, address, and telephone number of 
                the ultimate user or such contact information 
                of the ultimate user as the Secretary 
                determines appropriate.
                  (D) Identification of the drug by a national 
                drug code number.
                  (E) Quantity dispensed.
                  (F) Number of refills ordered.
                  (G) Whether the drug was dispensed as a 
                refill of a prescription or as a first-time 
                request.
                  (H) Date of the dispensing.
                  (I) Date of origin of the prescription.
                  (J) Such other information as may be required 
                by State law to be reported under this 
                subsection.
          (4) The State shall require dispensers to report 
        information under this section in accordance with the 
        electronic format specified by the Secretary under 
        [subsection (h)] subsection (j), 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.
          (5) The State shall report to the Secretary on--
                  (A) as appropriate, interoperability with the 
                controlled substance monitoring programs of 
                Federal departments and agencies;
                  (B) as appropriate, interoperability with 
                health information technology systems such as 
                electronic health records systems, health 
                information exchanges, and e-prescribing 
                systems; and
                  (C) whether or not the State provides 
                automatic, real-time or daily information about 
                a patient when a practitioner (or the designee 
                of a practitioner, where permitted) requests 
                information about such patient.
  (e) Database.--In [implementing or improving] establishing, 
improving, or maintaining 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] establishing, improving, or 
        maintaining a controlled substance monitoring program 
        under this section, a State may disclose information 
        from the database established under subsection (e) and, 
        in the case of a request under subparagraph (D), 
        summary statistics of such information, only in 
        response to a request by--
                  (A) a practitioner (or the agent thereof) who 
                certifies, under the procedures determined by 
                the State, that the requested information is 
                for the purpose of providing medical or 
                pharmaceutical treatment or evaluating the need 
                for such treatment to a bona fide current 
                patient;
                  (B) any local, State, or Federal law 
                enforcement, narcotics control, licensure, 
                disciplinary, or program authority, who 
                certifies, under the procedures determined by 
                the State, that the requested information is 
                related to an individual investigation or 
                proceeding involving the unlawful diversion or 
                [misuse of a schedule II, III, or IV substance] 
                misuse of a controlled substance included in 
                schedule II, III, or IV of section 202(c) of 
                the Controlled Substance Act, 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, a State substance 
                abuse agency, 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.
          (3) Evaluation and reporting.--Subject to subsection 
        (g), a State receiving a grant under subsection (a) 
        shall provide the Secretary with aggregate data and 
        other information determined by the Secretary to be 
        necessary to enable the Secretary--
                  (A) to evaluate the success of the State's 
                program in achieving its purposes; or
                  (B) to prepare and submit the report to 
                Congress required by subsection (l)(2).
          (4) Research by other entities.--A department, 
        program, or administration receiving nonidentifiable 
        information under paragraph (1)(D) may make such 
        information available to other entities for research 
        purposes.
  (g) Limitations.--In [implementing or improving] 
establishing, improving, or maintaining 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) Education and Access to the Monitoring System.--A State 
receiving a grant under subsection (a) shall take steps to--
          (1) facilitate prescriber and dispenser use of the 
        State's controlled substance monitoring system;
          (2) educate prescribers and dispensers on the 
        benefits of the system both to them and society; and
          (3) facilitate linkage to the State substance abuse 
        agency and substance abuse disorder services.
  (i) Consultation With Attorney General.--In carrying out this 
section, the Secretary shall consult with the Attorney General 
of the United States and other relevant Federal officials to--
          (1) ensure maximum coordination of controlled 
        substance monitoring programs and related activities; 
        and
          (2) minimize duplicative efforts and funding.
  [(h)] (j) Electronic Format.--The Secretary shall specify a 
uniform electronic format for the reporting, sharing, and 
disclosure of information under this section.
  [(i)] (k) Rules of Construction.--
          (1) Functions otherwise authorized by law.--Nothing 
        in this section shall be construed to restrict the 
        ability of any authority, including any local, State, 
        or Federal law enforcement, narcotics control, 
        licensure, disciplinary, or program authority, to 
        perform functions otherwise authorized by law.
          (2) No preemption.--Nothing in this section shall be 
        construed as preempting any State law, except that no 
        such law may relieve any person of a requirement 
        otherwise applicable under this Act.
          (3) Additional privacy protections.--Nothing in this 
        section shall be construed as preempting any State from 
        imposing any additional privacy protections.
          (4) Federal privacy requirements.--Nothing in this 
        section shall be construed to supersede any Federal 
        privacy or confidentiality requirement, including the 
        regulations promulgated under section 264(c) of the 
        Health Insurance Portability and Accountability Act of 
        1996 (Public Law 104-191; 110 Stat. 2033) and section 
        543 of the Public Health Service Act.
          (5) No federal private cause of action.--Nothing in 
        this section shall be construed to create a Federal 
        private cause of action.
  [(j)] (l) Studies and Reports.--
          (1) Implementation report.--
                  (A) In general.--Not later than 180 days 
                after the date of enactment of this section, 
                the Secretary, based on a review of existing 
                State controlled substance monitoring programs 
                and other relevant information, shall determine 
                whether the implementation of such programs has 
                had a substantial negative impact on--
                          (i) patient access to treatment, 
                        including therapy for pain or 
                        controlled substance abuse;
                          (ii) pediatric patient access to 
                        treatment; or
                          (iii) patient enrollment in research 
                        or clinical trials in which, following 
                        the protocol that has been approved by 
                        the relevant institutional review board 
                        for the research or clinical trial, the 
                        patient has obtained a controlled 
                        substance from either the scientific 
                        investigator conducting such research 
                        or clinical trial or the agent thereof.
                  (B) Additional categories of exclusion.--If 
                the Secretary determines under subparagraph (A) 
                that a substantial negative impact has been 
                demonstrated with regard to one or more of the 
                categories of patients described in such 
                subparagraph, the Secretary shall identify 
                additional appropriate categories of exclusion 
                from reporting as authorized under subsection 
                (d)(2)(C).
          (2) Progress report.--Not later than 3 years after 
        the date on which funds are first appropriated under 
        this section, the Secretary shall--
                  (A) complete a study that--
                          (i) determines the progress of States 
                        in establishing and implementing 
                        controlled substance monitoring 
                        programs under this section;
                          (ii) provides an analysis of the 
                        extent to which the operation of 
                        controlled substance monitoring 
                        programs have reduced inappropriate 
                        use, abuse, or diversion of controlled 
                        substances; established or strengthened 
                        initiatives to ensure linkages to 
                        substance use disorder services; or 
                        affected patient access to appropriate 
                        pain care in States operating such 
                        programs;
                          (iii) determines the progress of 
                        States in achieving interoperability 
                        between controlled substance monitoring 
                        programs and between controlled 
                        substance monitoring programs and 
                        health information technology systems, 
                        including an assessment of technical 
                        and legal barriers to such activities 
                        and recommendations for addressing 
                        these barriers;
                          (iv) determines the feasibility of 
                        implementing a real-time electronic 
                        controlled substance monitoring 
                        program, including the costs associated 
                        with establishing such a program;
                          (v) provides an analysis of the 
                        privacy protections in place for the 
                        information reported to the controlled 
                        substance monitoring program in each 
                        State receiving a grant for the 
                        establishment or operation of such 
                        program, and any recommendations for 
                        additional requirements for protection 
                        of this information;
                          (vi) determines the feasibility of 
                        implementing technological alternatives 
                        to centralized data storage, such as 
                        peer-to-peer file sharing or data 
                        pointer systems, in controlled 
                        substance monitoring programs and the 
                        potential for such alternatives to 
                        enhance the privacy and security of 
                        individually identifiable data; and
                          (vii) evaluates the penalties that 
                        States have enacted for the 
                        unauthorized use and disclosure of 
                        information maintained in the 
                        controlled substance monitoring 
                        program, and reports on the criteria 
                        used by the Secretary to determine 
                        whether such penalties qualify as 
                        appropriate pursuant to this section; 
                        and
                  (B) submit a report to the Congress on the 
                results of the study.
  [(k) Preference.--Beginning 3 years after the date on which 
funds are first appropriated to carry out this section, the 
Secretary, in awarding any competitive grant that is related to 
drug abuse (as determined by the Secretary) and for which only 
States are eligible to apply, shall give preference to any 
State with an application approved under this section. The 
Secretary shall have the discretion to apply such preference to 
States with existing controlled substance monitoring programs 
that meet minimum requirements under this section or to States 
that put forth a good faith effort to meet those requirements 
(as determined by the Secretary).]
  [(l)] (n) Advisory Council.--
          (1) Establishment.--A State may establish an advisory 
        council to assist in the establishment, implementation, 
        or improvement of a controlled substance monitoring 
        program under this section.
          (2) Limitation.--A State may not use amounts received 
        under a grant under this section for the operations of 
        an advisory council established under paragraph (1).
          (3) Sense of congress.--It is the sense of the 
        Congress that, in establishing an advisory council 
        under this subsection, a State should consult with 
        appropriate professional boards and other interested 
        parties.
  [(m)] (o) Definitions.--For purposes of this section:
          (1) The term ``bona fide patient'' means an 
        individual who is a patient of the practitioner 
        involved.
          (2) The term ``controlled substance'' means a drug 
        that is included in schedule II, III, or IV of section 
        202(c) of the Controlled Substance Act.
          (3) The term ``dispense'' means to deliver a 
        controlled substance to an ultimate user by, or 
        pursuant to the lawful order of, a practitioner, 
        irrespective of whether the dispenser uses the Internet 
        or other means to effect such delivery.
          (4) The term ``dispenser'' means a physician, 
        pharmacist, or other person that dispenses a controlled 
        substance to an ultimate user.
          (5) The term ``interoperability'' with respect to a 
        State controlled substance monitoring program means the 
        ability of the program to electronically share reported 
        information, including each of the required report 
        components described in subsection (d), with another 
        State if the information concerns either the dispensing 
        of a controlled substance to an ultimate user who 
        resides in such other State, or the dispensing of a 
        controlled substance prescribed by a practitioner whose 
        principal place of business is located in such other 
        State.
          (6) The term ``nonidentifiable information'' means 
        information that does not identify a practitioner, 
        dispenser, or an ultimate user and with respect to 
        which there is no reasonable basis to believe that the 
        information can be used to identify a practitioner, 
        dispenser, or an ultimate user.
          (7) The term ``practitioner'' means a physician, 
        dentist, veterinarian, scientific investigator, 
        pharmacy, hospital, or other person licensed, 
        registered, or otherwise permitted, by the United 
        States or the jurisdiction in which he or she practices 
        or does research, to distribute, dispense, conduct 
        research with respect to, administer, or use in 
        teaching or chemical analysis, a controlled substance 
        in the course of professional practice or research.
          (8) The term ``State'' means each of the 50 States 
        and the District of Columbia.
          (9) The term ``ultimate user'' means a person who has 
        obtained from a dispenser, and who possesses, a 
        controlled substance for his or her own use, for the 
        use of a member of his or her household, or for the use 
        of an animal owned by him or her or by a member of his 
        or her household.
  [(n)] (p) 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.

           *       *       *       *       *       *       *

                                  [all]
```