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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 507 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                 S. 507

   To provide for increased Federal oversight of prescription opioid 
treatment and assistance to States in reducing opioid abuse, diversion, 
                              and deaths.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             March 8, 2011

Mr. Rockefeller introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
   To provide for increased Federal oversight of prescription opioid 
treatment and assistance to States in reducing opioid abuse, diversion, 
                              and deaths.

    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 ``Prescription Drug Abuse Prevention 
and Treatment Act of 2011''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Nonmedical use of prescription pain relievers is a 
        matter of increasing public health concern. According to the 
        Substance Abuse and Mental Health Services Administration, the 
        proportion of all substance abuse treatment admissions aged 12 
        or older that reported any pain reliever abuse increased more 
        than 400 percent between 1998 and 2008, from 2.2 to 9.8 
        percent.
            (2) In 2008, among the population of the United States aged 
        12 or older, nonmedical use of prescription pain relievers was 
        the second most prevalent type of illicit drug use, after 
        marijuana use.
            (3) When used properly under medical supervision, 
        prescription opiates enable individuals with chronic pain to 
        lead productive lives. However, when taken without a 
        physician's oversight and direction, opiates can cause serious 
        adverse health effects, resulting in dependence, abuse, and 
        death.
            (4) As with any controlled substance, there is a risk of 
        abuse of methadone and other opiates.
            (5) Methadone is an extensively tested, federally approved, 
        and widely accepted method of treating addiction to 
        prescription pain relievers or opiates.
            (6) For more than 30 years, this synthetic prescription 
        drug has been used for pain management and treatment for 
        addiction to heroin, morphine, and other opioid drugs.
            (7) The efficacy and lower cost of methadone has resulted 
        in its being prescribed for pain management.
            (8) Prescriptions for methadone have increased by nearly 
        700 percent from 1998 through 2006.
            (9) According to the Centers for Disease Control and 
        Prevention, the number of poisoning deaths involving methadone 
        increased nearly 7-fold from almost 790 in 1999 to almost 5,420 
        in 2006, which is the most rapid increase among opioid 
        analgesics and other narcotics involved in poisoning deaths.
            (10) The age-specific rates of methadone death are higher 
        for persons age 35 to 44 and 45 to 54 than for other age 
        groups. However, the rate of methadone deaths in younger 
        individuals (age 15 to 24) increased 11-fold from 1999 through 
        2005.
            (11) Deaths from methadone and other opiates may actually 
        be underreported. There is no comprehensive database of drug-
        related deaths in the United States.
            (12) The lack of standardized reporting by Medical 
        Examiners precludes a uniform definition of ``cause of death'' 
        on death certificates.
            (13) The Controlled Substances Act (21 U.S.C. 801 et seq.) 
        requires that every person who dispenses or who proposes to 
        dispense controlled narcotics, including methadone, whether for 
        pain management or opioid treatment obtain a registration from 
        Drug Enforcement Administration. Unfortunately there is no 
        requirement as a condition of receiving the registration that 
        these practitioners receive any education on the use of these 
        controlled narcotics, including methadone.
            (14) Current Federal oversight of methadone and other 
        opioids is inadequate to address the growing number of opioid-
        related overdoses and deaths.
            (15) Federal legislation is needed to avert opioid abuse, 
        misuse, and death, without reducing patient access to needed 
        care.

SEC. 3. CONSUMER EDUCATION CAMPAIGN.

    Part A of title V of the Public Health Service Act (42 U.S.C. 290aa 
et seq.) is amended by adding at the end the following:

``SEC. 506C. CONSUMER EDUCATION CAMPAIGN.

    ``(a) In General.--The Administrator shall award grants to States 
and nonprofit entities for the purpose of conducting culturally 
sensitive consumer education about opioid abuse, including methadone 
abuse. Such education shall include information on the dangers of 
opioid abuse, how to prevent opioid abuse including through safe 
disposal of prescription medications and other safety precautions, and 
detection of early warning signs of addiction.
    ``(b) Eligibility.--To be eligible to receive a grant under 
subsection (a), an entity shall--
            ``(1) be a State or nonprofit entity; and
            ``(2) submit to the Administrator an application at such 
        time, in such manner, and containing such information as the 
        Administrator may require.
    ``(c) Priority.--In awarding grants under this section, the 
Administrator shall give priority to applicants that are States or 
communities with a high incidence of abuse of methadone and other 
opioids, and opioid-related deaths.
    ``(d) Evaluations.--The Administrator shall develop a process to 
evaluate the effectiveness of activities carried out by grantees under 
this section at reducing abuse of methadone and other opioids.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $15,000,000 for each of fiscal 
years 2012 through 2016.''.

SEC. 4. PRACTITIONER EDUCATION.

    (a) Education Requirements.--
            (1) Registration consideration.--Section 303(f) of the 
        Controlled Substances Act (21 U.S.C. 823(f)) is amended by 
        inserting after paragraph (5) the following:
            ``(6) The applicant's compliance with the training 
        requirements described in subsection (g)(3) during any previous 
        period in which the applicant has been subject to such training 
        requirements.''.
            (2) Training requirements.--Section 303(g) of the 
        Controlled Substances Act (21 U.S.C. 823(g)) is amended by 
        adding at the end the following:
    ``(3)(A) To be registered to prescribe or otherwise dispense 
methadone or other opioids, a practitioner described in paragraph (1) 
shall comply with the 16-hour training requirement of subparagraph (B) 
at least once during each 3-year period.
    ``(B) The training requirement of this subparagraph is that the 
practitioner has completed not less than 16 hours of training (through 
classroom situations, seminars at professional society meetings, 
electronic communications, or otherwise) with respect to--
            ``(i) the treatment and management of opioid-dependent 
        patients;
            ``(ii) pain management treatment guidelines; and
            ``(iii) early detection of opioid addiction, including 
        through such methods as Screening, Brief Intervention, and 
        Referral to Treatment (SBIRT),
that is provided by the American Society of Addiction Medicine, the 
American Academy of Addiction Psychiatry, the American Medical 
Association, the American Osteopathic Association, the American 
Psychiatric Association, the American Academy of Pain Management, the 
American Pain Society, the American Academy of Pain Medicine, the 
American Board of Pain Medicine, the American Society of Interventional 
Pain Physicians, or any other organization that the Secretary 
determines is appropriate for purposes of this subparagraph.''.
    (b) Requirements for Participation in Opioid Treatment Programs.--
Effective July 1, 2012, a physician practicing in an opioid treatment 
program shall comply with the requirements of section 303(g)(3) of the 
Controlled Substances Act (as added by subsection (a)) with respect to 
required minimum training at least once during each 3-year period.
    (c) Definition.--In this section, the term ``opioid treatment 
program'' has the meaning given such term in section 8.2 of title 42, 
Code of Federal Regulations (or any successor regulation).
    (d) Funding.--The Drug Enforcement Administration shall fund the 
enforcement of the requirements specified in section 303(g)(3) of the 
Controlled Substances Act (as added by subsection (a)) through the use 
of a portion of the licensing fees paid by controlled substance 
prescribers under the Controlled Substances Act (21 U.S.C. 801 et 
seq.).

SEC. 5. MORATORIUM ON METHADONE HYDROCHLORIDE TABLETS.

    (a) In General.--Notwithstanding any other provision of law, during 
the period beginning on the date of enactment of this Act and ending on 
the date described in subsection (b), no individual or entity may 
prescribe or otherwise dispense a 40-mg diskette of methadone unless 
such prescription or dispensation is consistent with the methadone 40-
mg diskette policy of the Drug Enforcement Administration as in effect 
on the date of enactment of this Act, except that such prohibition 
shall extend to hospitals unless such hospitals provide for direct 
patient supervision with respect to such methadone.
    (b) Ending Date of Moratorium.--The moratorium under subsection (a) 
shall cease to have force and effect--
            (1) on the date that the Controlled Substances Clinical 
        Standards Commission publishes in the Federal Register dosing 
        guidelines for all forms of methadone, in accordance with 
        section 506D(b)(1)(A) of the Public Health Service Act (as 
        added by section 7); and
            (2) if, as part of such dosing guidelines, such Commission 
        finds that 40-mg diskettes of methadone are safe and clinically 
        appropriate.

SEC. 6. OPERATION OF OPIOID TREATMENT PROGRAMS.

    Section 303 of the Controlled Substances Act (21 U.S.C. 823) is 
amended by adding at the end the following:
    ``(i)(1) An opioid treatment program that is registered under this 
section, and that closes for business on any weekday or weekend day, 
including a Federal or State holiday, shall comply with the 
requirements of this subsection.
    ``(2) The program shall make acceptable arrangements for each 
patient who is restricted, by Federal regulation or guideline or by the 
determination of the program medical director, from having a take home 
dose of a controlled substance related to the treatment involved, to 
receive a dose of that substance under appropriate supervision during 
the closure.
    ``(3) The Administrator of the Substance Abuse and Mental Health 
Services Administration shall issue a notice that references 
regulations on acceptable arrangements under this subsection, or shall 
promulgate regulations on such acceptable arrangements.''.

SEC. 7. ESTABLISHMENT OF THE CONTROLLED SUBSTANCES CLINICAL STANDARDS 
              COMMISSION.

    Part A of title V of the Public Health Service Act (42 U.S.C. 290aa 
et seq.), as amended by section 3, is further amended by adding at the 
end the following:

``SEC. 506D. ESTABLISHMENT OF THE CONTROLLED SUBSTANCES CLINICAL 
              STANDARDS COMMISSION.

    ``(a) In General.--The Secretary shall establish a Controlled 
Substances Clinical Standards Commission (referred to in this section 
as the `Commission'), to be composed of representatives from the 
Administration, the Centers for Disease Control and Prevention, the 
Food and Drug Administration, the Pain Management Consortia of the 
National Institutes of Health, and other agencies that the Secretary 
may deem necessary, to develop--
            ``(1) appropriate and safe dosing guidelines for all forms 
        of methadone, including recommendations for maximum daily doses 
        of all forms as provided for in subsection (b)(1);
            ``(2) benchmark guidelines for the reduction of methadone 
        abuse, as provided for in subsection (b)(2);
            ``(3) appropriate conversion factors for use by health care 
        providers in transitioning patients from one opioid to another;
            ``(4) specific guidelines for initiating pain management 
        with methadone that prescribing practitioners shall comply with 
        in order to meet certification requirements set forth in part C 
        of the Controlled Substances Act (21 U.S.C. 821 et seq.); and
            ``(5) patient and practitioner education guidelines for 
        both methadone maintenance therapy and pain management that 
        apply to safe and effective use and include detoxification.
    ``(b) Guidelines.--
            ``(1) Publication of dosing guidelines.--
                    ``(A) In general.--Not later than 2 years after the 
                date of enactment of this section, the Commission 
                established under subsection (a) shall publish in the 
                Federal Register--
                            ``(i) safe and clinically appropriate 
                        dosing guidelines for all forms of methadone 
                        used for both pain management and opioid 
                        treatment programs, including recommendations 
                        for maximum daily doses of all forms, including 
                        recommendations for the induction process for 
                        patients who are newly prescribed methadone;
                            ``(ii) requirements for individual patient 
                        care plans, including initial and follow-up 
                        patient physical examination guidelines, and 
                        recommendations for screening patients for 
                        chronic or acute medical conditions that may 
                        cause an immediate and adverse reaction to 
                        methadone;
                            ``(iii) appropriate conversion factors for 
                        use by health care providers in transitioning 
                        patients from one opioid to another;
                            ``(iv) specific guidelines for initiating 
                        pain management with methadone, that 
                        prescribing physicians or other clinicians 
                        shall comply with in order to meet Drug 
                        Enforcement Administration certification and 
                        re-certification requirements; and
                            ``(v) consensus guidelines for pain 
                        management with prescription opioid drugs.
                    ``(B) Updating of guidelines.--Not later than 3 
                years after the publication of guidelines under 
                subparagraph (A), and at least every 3 years 
                thereafter, the Commission shall update such 
                guidelines.
            ``(2) Publication of benchmark guidelines.--
                    ``(A) In general.--Not later than 3 years after the 
                date of enactment of this section, the Commission 
                established under subsection (a) shall publish in the 
                Federal Register--
                            ``(i) the initial benchmark guidelines for 
                        the reduction of methadone abuse to be used--
                                    ``(I) by opioid treatment programs 
                                in providing methadone therapy; and
                                    ``(II) by entities in the initial 
                                accreditation or certification, and the 
                                re-accreditation and re-certification, 
                                of such opioid treatment programs;
                            ``(ii) a model policy for dispensing 
                        methadone to be used by pharmacists that 
                        dispense methadone, which should include 
                        education and training guidelines for such 
                        pharmacists;
                            ``(iii) the continuing education guidelines 
                        that all prescribers shall comply with in order 
                        to meet Drug Enforcement Administration 
                        certification and re-certification 
                        requirements, as set forth in section 303(g)(3) 
                        of the Controlled Substances Act (21 U.S.C. 
                        823(g)(3)), which should include a minimum of 
                        16 training hours at least every 3 years that 
                        include the integration of both addiction and 
                        pain management curricula; and
                            ``(iv) patient education guidelines for 
                        both opioid treatment programs and pain 
                        management, including recommendations for 
                        patient counseling prior to and during opioid 
                        addiction treatment or treatment for pain.
                    ``(B) Updating of guidelines.--Not later than 1 
                year after the publication of guidelines under 
                subparagraph (A), and at least annually thereafter, the 
                Commission shall update the guidelines published under 
                clauses (iii) and (iv) of such subparagraph.
            ``(3) Consultation.--In developing and publishing the 
        guidelines under this section, the Commission shall consult 
        with relevant professional organizations with expertise in the 
        area of addiction, relevant professional organizations with 
        expertise in the area of pain management, physician groups, 
        pharmacy groups (including the National Association of Boards 
        of Pharmacy), patient representatives, and any other 
        organization that the Secretary determines is appropriate for 
        purposes of this section.
    ``(c) Website.--Not later than 180 days after the date of enactment 
of this section, the Commission shall establish and operate a 
Commission website.
    ``(d) Methadone Toolkit.--Not later than 1 year after the date of 
enactment of this section, the Commission shall establish, and 
distribute to practitioners that are registered to prescribe or 
otherwise dispense methadone, a methadone toolkit. The Commission shall 
make the components of the toolkit that are available in electronic 
form available on the Commission website.
    ``(e) Practitioner Education Program.--The Commission shall develop 
a practitioner education program that shall be used for the 
practitioner education described in section 303(g)(3) of the Controlled 
Substances Act, and shall make such program available to providers of 
such practitioner education.
    ``(f) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each of fiscal years 2012 through 2016.''.

SEC. 8. PRESCRIPTION MONITORING PROGRAM.

    Section 399O of the Public Health Service Act (42 U.S.C. 280g-3) is 
amended--
            (1) in subsection (d)(1), by inserting ``(including 
        prescribers of methadone)'' after ``dispensers'';
            (2) in subsection (e), by adding at the end the following:
            ``(5) Subject to the requirements of section 543, the State 
        shall, at the request of a Federal, State, or local officer 
        whose duties include enforcing laws relating to drugs, provide 
        to such officer information from the database relating to an 
        individual who is the subject of an active drug-related 
        investigation conducted by the officer's employing government 
        entity.''; and
            (3) by striking subsection (n) and inserting the following:
    ``(n) Appropriations.--There is authorized to be appropriated to 
carry out this section $25,000,000 for each of fiscal years 2012 
through 2016.''.

SEC. 9. MORTALITY REPORTING.

    Part A of title V of the Public Health Service Act (42 U.S.C. 290aa 
et seq.), as amended by section 7, is further amended by adding at the 
end the following:

``SEC. 506E. MORTALITY REPORTING.

    ``(a) Model Opioid Treatment Program Mortality Report.--
            ``(1) In general.--Not later than July 1, 2012, the 
        Secretary, acting through the Administrator, shall require that 
        a Model Opioid Treatment Program Mortality Report be completed 
        and submitted to the Administrator for each individual who dies 
        while receiving treatment in an opioid treatment program.
            ``(2) Requirement of states that receive funding for the 
        controlled substance monitoring program.--As a condition for 
        receiving funds under section 399O, each State shall require 
        that any individual who signs a death certificate where an 
        opioid drug is detected in the body of the deceased, or where 
        such drug is otherwise associated with the death, report such 
        death to the Administrator by submitting a Model Opioid 
        Treatment Program Mortality Report described in paragraph (3). 
        Such report shall be submitted to the Administrator on or 
        before the later of--
                    ``(A) 90 days after the date of signing the death 
                certificate; or
                    ``(B) as soon as practicable after the date on 
                which the necessary postmortem and toxicology reports 
                become available to such individual, as required by the 
                Secretary.
            ``(3) Development.--The Administrator, in consultation with 
        State and local medical examiners, prescribing physicians, 
        hospitals, and any other organization that the Administrator 
        determines appropriate, shall develop a Model Opioid Treatment 
        Program Mortality Report to be used under paragraphs (1) and 
        (2).
    ``(b) National Opioid Death Registry.--
            ``(1) In general.--Not later than July 1, 2012, the 
        Administrator shall establish and implement, through the 
        National Center for Health Statistics, a National Opioid Death 
        Registry (referred to in this subsection as the `Registry') to 
        track opioid-related deaths and information related to such 
        deaths.
            ``(2) Consultation.--In establishing the uniform reporting 
        criteria for the Registry, the Director of the Centers for 
        Disease Control and Prevention shall consult with the 
        Administrator, State and local medical examiners, prescribing 
        physicians, hospitals, and any other organization that the 
        Director determines is appropriate for purposes of this 
        subsection.
            ``(3) Requirements.--The registry shall be designed as a 
        uniform reporting system for opioid-related deaths and shall 
        require the reporting of information with respect to such 
        deaths, including--
                    ``(A) the particular drug formulation used at the 
                time of death;
                    ``(B) the dosage level;
                    ``(C) a description of the circumstances 
                surrounding the death in relation to the recommended 
                dosage involved;
                    ``(D) a disclosure of whether the medication 
                involved can be traced back to a physician's 
                prescription;
                    ``(E) a disclosure of whether the individual was in 
                an opioid treatment program at the time of death;
                    ``(F) the age and sex of the individual; and
                    ``(G) other non-personal information such as that 
                included in filed National Association of Medical 
                Examiners Pediatric Toxicology Registry case reports as 
                required under the privacy standard for the de-
                identification of health information pursuant to the 
                regulations contained in part 164 of title 45, Code of 
                Federal Regulations.
            ``(4) Authorization.--There is authorized to be 
        appropriated $5,000,000 for each of fiscal years 2012 through 
        2016 to carry out this subsection.
    ``(c) Report on Registry Information.--Not later than the January 1 
of the first fiscal year beginning 2 years after the date of enactment 
of this section, and each January 1 thereafter, the Director of the 
Centers for Disease Control and Prevention shall submit to the 
Secretary a report, based on information contained in the Registry 
described in subsection (b), concerning the number of methadone-related 
deaths in the United States for the year for which the report is 
submitted.''.

SEC. 10. ADDITIONAL REPORTING.

    Part A of title V of the Public Health Service Act (42 U.S.C. 290aa 
et seq.), as amended by section 9, is further amended by adding at the 
end the following:

``SEC. 506F. ADDITIONAL REPORTING.

    ``(a) Report on Methadone Usage.--
            ``(1) In general.--Not later than January 1 of the first 
        fiscal year beginning 2 years after the date of enactment of 
        this section, and each January 1 thereafter, the Administrator 
        and the Commissioner of Food and Drugs shall submit to the 
        Secretary a report containing detailed statistics on methadone 
        usage for opioid treatment and pain management. Such statistics 
        shall include--
                    ``(A) information on the distribution of prescribed 
                doses of methadone at federally qualified health 
                centers, opioid treatment clinics, other health-related 
                clinics, physician offices, pharmacies, and hospitals; 
                and
                    ``(B) information relating to adverse health events 
                resulting from such methadone usage.
            ``(2) Availability of information.--The Secretary shall 
        make the reports submitted under paragraph (1) available to the 
        general public, including through the use of the Internet 
        website of the Department of Health and Human Services.
    ``(b) Annual Report on Effectiveness.--Not later than September 30, 
2012, and annually thereafter until September 30, 2016, the Secretary 
shall submit to the appropriate committees of Congress, a report 
concerning the effectiveness of the methadone maintenance therapy 
program. Such report shall evaluate the success of efforts to reduce 
opioid addiction and methadone-related deaths, including the impact of 
health care provider and patient education.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each of fiscal years 2012 through 2016.''.
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