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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5531 Introduced in House (IH)]

<DOC>

115th CONGRESS
  2d Session
                                H. R. 5531

To provide for a comprehensive, multifaceted approach to preventing and 
                       treating opioid addiction.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             April 17, 2018

 Mr. Buchanan (for himself and Mrs. Murphy of Florida) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committees on Ways and Means, the 
  Budget, Veterans' Affairs, Oversight and Government Reform, and the 
 Judiciary, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL

 
To provide for a comprehensive, multifaceted approach to preventing and 
                       treating opioid addiction.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Opioid Emergency 
Response Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Alternatives to opioids prescribing.
Sec. 3. Opioids and STOP Pain Initiative.
Sec. 4. Veteran over-medication prevention.
Sec. 5. Amendment relating to the account for the State response to the 
                            opioid abuse crisis.
Sec. 6. Mental health access improvement.
Sec. 7. Synthetics Trafficking and Overdose Prevention.
Sec. 8. Stop the Importation and Trafficking of Synthetic Analogues.

SEC. 2. ALTERNATIVES TO OPIOIDS PRESCRIBING.

    (a) Establishment.--Beginning not later than one year after the 
date of the enactment of this Act, the Secretary of Health and Human 
Services (in this Act referred to as the ``Secretary'') shall carry out 
a 5-year demonstration project under which payment shall be made under 
the hospital outpatient prospective payment system under part B of 
title XVIII of the Social Security Act (42 U.S.C. 1395j et seq.) to 
participating hospitals for items and services furnished as 
alternatives to opioid medications to individuals enrolled under such 
part to treat conditions designated under subsection (c)(1) for 
purposes of evaluating the benefits of using, instead of opioid 
medications, such alternatives to treat in emergency departments such 
symptoms and conditions.
    (b) Emergency Departments.--
            (1) Selection.--The Secretary shall select from hospitals 
        with emergency departments voluntarily submitting applications 
        under paragraph (4), not fewer than 30 hospitals with emergency 
        departments, and not more than 50 hospitals with emergency 
        departments, for participation in the demonstration project.
            (2) Diversity.--In selecting hospitals with emergency 
        departments, the Secretary shall ensure such hospitals and 
        emergency departments are diverse in geography and size.
            (3) Voluntary participation.--Participation in the 
        demonstration project under this section shall be on a 
        voluntary basis.
            (4) Applications.--
                    (A) In general.--To participate in the 
                demonstration project, a hospital with an emergency 
                department shall submit to the Secretary an application 
                at such time, in such manner, and containing such 
                information (in addition to the written commitment 
                described in subparagraph (B)) as specified by the 
                Secretary. The Secretary shall take such measures as is 
                necessary to make available such application form to 
                potential participants no later than 180 days after the 
                date of the enactment of this Act.
                    (B) Information required.--Each application 
                submitted by a hospital under subparagraph (A) shall 
                include a binding written commitment to participate in 
                the demonstration project for the duration of the 
                project signed by the Chief Executive Officer of the 
                hospital, the physician medical director of the 
                emergency department of the hospital, the nursing 
                director of the emergency department of the hospital, 
                and the pharmacy director of the emergency department 
                of the hospital.
    (c) Elements of Demonstration Project.--Under the demonstration 
project, the following shall apply:
            (1) The Secretary shall designate no fewer than five 
        conditions or sets of symptoms that will be monitored during 
        the demonstration project.
            (2) The performance during each year of the demonstration 
        project, with respect to such conditions designated under 
        paragraph (1), of all emergency departments of hospitals 
        participating in the demonstration project will be measured 
        against the performance of such emergency departments during a 
        base year, which shall represent the most recent set of full 
        year data available before the first date of the demonstration 
        project.
            (3) The Secretary shall provide hospitals participating in 
        the demonstration project with a description of clearly defined 
        treatments that are considered alternatives to opioids to be 
        applied for purposes of subsection (a).
    (d) Incentive Payment.--Under the demonstration project, the 
Secretary shall create a payment structure under which hospitals 
participating in the demonstration project that increase the use of 
alternatives to opioids and decrease the use of opioids may receive a 
shared savings bonus in addition to what would otherwise be made for 
items and services furnished under subsection (a). The amount of such 
shared savings shall be based on the difference between readmission 
rates for individuals treated with an alternative to opioids at the 
emergency department of the participating hospital and the average rate 
of readmissions for individuals treated with opioids and discharged 
from a representative group of emergency departments of hospitals not 
participating in the demonstration project in the same region as the 
participating hospital over a period of five years.
    (e) Clarification.--Nothing under this section shall prevent a 
health care provider from prescribing an opioid if an opioid is a 
medically necessary treatment.
    (f) Reports to Congress.--
            (1) Initial report.--Not later than 180 days after the date 
        of the enactment of this Act, the Secretary shall submit to 
        Congress a report that includes--
                    (A) the application form described in subsection 
                (b)(4)(A) that is to be made available to potential 
                participants; and
                    (B) a progress report with respect to designating 
                the conditions under subsection (c)(1) and establishing 
                the description of clearly defined treatments described 
                in subsection (c)(3).
            (2) Periodic demonstration reports.--Beginning after the 
        first year of the demonstration project and annually thereafter 
        for each year of the demonstration project and not later than 
        one year after the completion of the demonstration, the 
        Secretary shall submit to Congress a report that includes the 
        following data for each hospital participating under the 
        demonstration project:
                    (A) With respect to each condition or set of 
                symptom designated under subsection (c)(1), the number 
                of individuals treated.
                    (B) With respect to each such condition, the number 
                of individuals treated only with an alternative to 
                opioids.
                    (C) With respect to each such condition, the number 
                of individuals treated first with an alternative to 
                opioids, followed by an opioid in the same visit.
                    (D) With respect to each such condition, the number 
                of individuals treated only with an opioid.
                    (E) With respect to each individual described in 
                subparagraph (A) treated for such a condition or set of 
                symptoms, whether or not the individual involved 
                returned to the emergency department of the hospital or 
                an emergency department of a different hospital for the 
                same condition or symptoms.
                    (F) The difference in cost between treating an 
                individual with an alternative to opioid versus an 
                opioid.
                    (G) Any additional information the Secretary 
                determines necessary.

SEC. 3. OPIOIDS AND STOP PAIN INITIATIVE.

    (a) Establishment.--There is established an Opioids and STOP Pain 
Initiative, to be administered by the Director of the National 
Institutes of Health, in coordination with other agencies, as 
appropriate, which shall include efforts to support research on the 
following:
            (1) Section 108 of the Comprehensive Addiction and Recovery 
        Act of 2016 (42 U.S.C. 284q-1), known as the STOP Pain Act, 
        which directs the National Institutes of Health to intensify 
        and coordinate fundamental, translational, and clinical 
        research with respect to--
                    (A) the understanding of pain;
                    (B) the discovery and development of therapies for 
                chronic pain; and
                    (C) the development of alternatives to opioids for 
                effective pain treatments.
            (2) Developing improved options and evidence for 
        medication-assisted treatment.
            (3) Developing improved options and evidence for opioid 
        overdose reversal treatments.
            (4) The Federal Pain Research Strategy, including research 
        that focuses on--
                    (A) novel drugs, non-addictive, and non-
                pharmacological treatments for pain;
                    (B) screening tools and outcome measure for 
                assessments across the continuum of pain;
                    (C) national registries, datasets, and research 
                networks;
                    (D) effective models of care delivery for pain 
                management; and
                    (E) precision medicine methodology to prevent and 
                treat pain.
            (5) The components of the Department of Health and Human 
        Services five-point strategy to address the opioid crisis that 
        states: ``Providing support for cutting edge research on pain 
        and addiction''.
            (6) The pain therapy screening program established under 
        subsection (c).
            (7) Other elements that the Secretary of Health and Human 
        Services may designate, in consultation with the Director of 
        the National Institutes of Health.
    (b) Funding for the Opioids and STOP Pain Initiative.--
            (1) In general.--There is authorized to be appropriated, 
        and there is appropriated, $500,000,000, to be used during the 
        5-fiscal-year period beginning in the fiscal year in which such 
        funds are appropriated, to the National Institutes of Health 
        Innovation Account to be used to administer the Opioids and 
        STOP Pain Initiative established under subsection (a).
            (2) Emergency spending.--
                    (A) In general.--Amounts appropriated under 
                paragraph (1) are designated as an emergency 
                requirement pursuant to section 4(g) of the Statutory 
                Pay-As-You-Go Act of 2010 (2 U.S.C. 933(g)).
                    (B) Designation in the senate.--In the Senate, 
                amounts appropriated under subsection (a) are 
                designated as an emergency requirement pursuant to 
                section 403(a) of S. Con. Res. 13 (111th Congress), the 
                concurrent resolution on the budget for fiscal year 
                2010.
    (c) Pain Therapy Screening Program.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary'') shall carry 
        out through the National Institutes of Health a program to be 
        known as the ``Pain Therapy Screening Program'' that focuses on 
        the development of pain therapeutics.
            (2) Grants.--The Secretary shall award grants under the 
        program under paragraph (1) to eligible public and private 
        nonprofit entities to support the development of new pre-
        clinical models for pain disorders, and the application of 
        these models in drug, device, or other therapy screening.
            (3) Model.--The program under this section shall be modeled 
        after the Epilepsy Therapy Screening Program carried out by the 
        National Institute of Neurological Disorders and Stroke.
            (4) Fees.--The Secretary of Health and Human Services may 
        assess reasonable fees on private pharmaceutical or medical 
        device industry entities that utilize the program under this 
        section to screen proprietary molecular compounds and devices. 
        Such fees shall be paid to the Foundation for the National 
        Institutes of Health and transferred to the NIH Innovation 
        Account to be used for the Opioids and STOP Pain Initiative 
        established under subsection (a).
            (5) Funding.--The Director of the National Institutes of 
        Health shall determine the amount, and allocate, funds from the 
        amount appropriated under subsection (b), to carry out this 
        section.
    (d) Funding Provisions.--
            (1) Supplement not supplant.--Amounts appropriated in this 
        section (including the amendments made by this section) shall 
        be used to supplement, not supplant, current funding for pain 
        and opioid research at the National Institutes of Health.
            (2) Acceptance of donations.--Notwithstanding section 1342 
        of title 31, United States Code, the Secretary of Health and 
        Human Services may accept donations (including from the 
        pharmaceutical and medical device industries) to be used to 
        assist in carrying out programs and activities under this 
        section (and the amendments made by this section). Such 
        donations shall be paid to the Foundation for the National 
        Institutes of Health and transferred to the NIH Innovation 
        Account to be used for the Opioids and STOP Pain Initiative 
        established under subsection (a).
            (3) Inclusion of contribution amounts in basic research for 
        purposes of research credit.--
                    (A) In general.--Paragraph (6) of section 41(e) of 
                the Internal Revenue Code of 1986 is amended by adding 
                at the end the following new subparagraph:
                    ``(E) Opioids and stop pain initiative.--The 
                National Institutes of Health, if the payment is made 
                in support of the Opioids and STOP Pain Initiative, as 
                established by the Opioids and STOP Pain Initiative 
                Act.''.
                    (B) Effective date.--The amendments made by this 
                subsection shall apply to taxable years beginning after 
                the date of the enactment of this Act.
    (e) Authority.--Notwithstanding any other provision of the law, the 
Director of the National Institutes of Health may use funds available 
under subsection (b) to enter into transactions (other than contracts, 
cooperative agreements, or grants) to carry out research identified 
pursuant to the Opioids and STOP Pain Initiative established under 
subsection (a).
    (f) Reports.--
            (1) Annual reports.--Not later than October 1 of each of 
        fiscal years 2019 through 2026, the Director of the National 
        Institutes of Health shall submit to the Committee on Health, 
        Education, Labor, and Pensions and the Committee on 
        Appropriations of the Senate and the Committee on Energy and 
        Commerce and the Committee on Appropriations of the House of 
        Representatives, a report that includes--
                    (A) the amount obligated or expended in the fiscal 
                year prior to the fiscal year in which the report is 
                being submitted for each program or activity described 
                in this section (or an amendment made by this section);
                    (B) a description of all such programs or 
                activities carried out using funds provided under this 
                section (or amendments); and
                    (C) a description of how such programs or 
                activities are advancing public health, including the 
                impact on treating pain and addressing opioid misuse in 
                the United States.
            (2) Additional reports.--At the request of the Committee on 
        Health, Education, Labor, and Pensions or the Committee on 
        Appropriations of the Senate, or the Committee on Energy and 
        Commerce or the Committee on Appropriations of the House of 
        Representatives, the Director of the National Institutes of 
        Health shall provide to the relevant committee an update in the 
        form of testimony and additional reports concerning the 
        allocation of funding under this section (or the amendments 
        made by this section) or the description of the programs and 
        activities carried out with such funding.

SEC. 4. VETERAN OVER-MEDICATION PREVENTION.

    (a) Review Required.--
            (1) In general.--Not later than 90 days after the date of 
        the enactment of this Act, the Secretary of Veterans Affairs 
        shall seek to enter into an agreement with the National 
        Academies of Sciences, Engineering, and Medicine under which 
        the National Academies shall conduct a review of the deaths of 
        all covered veterans who died by suicide during the five-year 
        period ending on the date of the enactment of this Act, 
        regardless of whether information relating to such deaths has 
        been reported by the Centers for Disease Control and 
        Prevention.
            (2) Elements.--The review required by paragraph (1) shall 
        include the following:
                    (A) The total number of covered veterans who died 
                by suicide during the five-year period ending on the 
                date of the enactment of this Act.
                    (B) The total number of covered veterans who died 
                by a violent death during such five-year period.
                    (C) The total number of covered veterans who died 
                by an accidental death during such five-year period.
                    (D) A description of each covered veteran described 
                in subparagraphs (A) through (C), including age, 
                gender, race, and ethnicity.
                    (E) A comprehensive list of prescribed medications 
                and legal or illegal substances as annotated on 
                toxicology reports of covered veterans described in 
                subparagraphs (A) through (C), specifically listing any 
                medications that carried a black box warning, were 
                prescribed for off-label use, were psychotropic, or 
                carried warnings that included suicidal ideation.
                    (F) A summary of medical diagnoses by physicians of 
                the Department of Veterans Affairs or physicians 
                providing services to covered veterans through programs 
                of the Department that led to the prescribing of 
                medications referred to in subparagraph (E) in cases of 
                post-traumatic stress disorder, traumatic brain injury, 
                military sexual trauma, and other anxiety and 
                depressive disorders.
                    (G) The number of instances in which a covered 
                veteran described in subparagraph (A), (B), or (C) was 
                concurrently on multiple medications prescribed by 
                physicians of the Department or physicians providing 
                services to veterans through programs of the Department 
                to treat post-traumatic stress disorder, traumatic 
                brain injury, military sexual trauma, other anxiety and 
                depressive disorders, or instances of comorbidity.
                    (H) The number of covered veterans described in 
                subparagraphs (A) through (C) who were not taking any 
                medication prescribed by a physician of the Department 
                or a physician providing services to veterans through a 
                program of the Department.
                    (I) With respect to the treatment of post-traumatic 
                stress disorder, traumatic brain injury, military 
                sexual trauma, or other anxiety and depressive 
                disorders, the percentage of covered veterans described 
                in subparagraphs (A) through (C) who received a non-
                medication first-line treatment compared to the 
                percentage of such veterans who received medication 
                only.
                    (J) With respect to the treatment of covered 
                veterans described in subparagraphs (A) through (C) for 
                post-traumatic stress disorder, traumatic brain injury, 
                military sexual trauma, or other anxiety and depressive 
                disorders, the number of instances in which a non-
                medication first-line treatment (such as cognitive 
                behavioral therapy) was attempted and determined to be 
                ineffective for such a veteran, which subsequently led 
                to the prescribing of a medication referred to in 
                subparagraph (E).
                    (K) A description and example of how the Department 
                determines and continually updates the clinical 
                practice guidelines governing the prescribing of 
                medications.
                    (L) An analysis of the use by the Department, 
                including protocols or practices at medical facilities 
                of the Department, of systematically measuring pain 
                scores during clinical encounters under the Pain as the 
                5th Vital Sign Toolkit of the Department and an 
                evaluation of the relationship between the use of such 
                measurements and the number of veterans concurrently on 
                multiple medications prescribed by physicians of the 
                Department.
                    (M) A description of the efforts of the Department 
                to maintain appropriate staffing levels for mental 
                health professionals, such as mental health counselors, 
                marriage and family therapists, and other appropriate 
                counselors, including--
                            (i) a description of any impediments to 
                        carry out the education, training, and hiring 
                        of mental health counselors and marriage and 
                        family therapists under section 7302(a) of 
                        title 38, United States Code, and strategies 
                        for addressing those impediments;
                            (ii) a description of the objectives, 
                        goals, and timing of the Department with 
                        respect to increasing the representation of 
                        such counselors and therapists in the 
                        behavioral health workforce of the Department, 
                        including--
                                    (I) a review of eligibility 
                                criteria for such counselors and 
                                therapists and a comparison of such 
                                criteria to that of other behavioral 
                                health professions in the Department; 
                                and
                                    (II) an assessment of the 
                                participation of such counselors and 
                                therapists in the mental health 
                                professionals trainee program of the 
                                Department and any impediments to such 
                                participation;
                            (iii) an assessment of the development by 
                        the Department of hiring guidelines for mental 
                        health counselors, marriage and family 
                        therapists, and other appropriate counselors;
                            (iv) a description of how the Department--
                                    (I) identifies gaps in the supply 
                                of mental health professionals; and
                                    (II) determines successful staffing 
                                ratios for mental health professionals 
                                of the Department;
                            (v) a description of actions taken by the 
                        Secretary, in consultation with the Director of 
                        the Office of Personnel Management, to create 
                        an occupational series for mental health 
                        counselors and marriage and family therapists 
                        of the Department and a timeline for the 
                        creation of such an occupational series; and
                            (vi) a description of actions taken by the 
                        Secretary to ensure that the national, 
                        regional, and local professional standards 
                        boards for mental health counselors and 
                        marriage and family therapists are comprised of 
                        only mental health counselors and marriage and 
                        family therapists and that the liaison from the 
                        Department to such boards is a mental health 
                        counselor or marriage and family therapist.
                    (N) The percentage of covered veterans described in 
                subparagraphs (A) through (C) with combat experience or 
                trauma related to combat experience (including military 
                sexual trauma, traumatic brain injury, and post-
                traumatic stress).
                    (O) An identification of the medical facilities of 
                the Department with markedly high prescription rates 
                and suicide rates for veterans receiving treatment at 
                those facilities.
                    (P) An analysis, by State, of programs of the 
                Department that collaborate with State Medicaid 
                agencies and the Centers for Medicare and Medicaid 
                Services, including the following:
                            (i) An analysis of the sharing of 
                        prescription and behavioral health data for 
                        veterans.
                            (ii) An analysis of whether Department 
                        staff check with State prescription drug 
                        monitoring programs before prescribing 
                        medications to veterans.
                            (iii) A description of the procedures of 
                        the Department for coordinating with 
                        prescribers outside of the Department to ensure 
                        that veterans are not overprescribed.
                            (iv) A description of actions that the 
                        Department takes when a veteran is determined 
                        to be overprescribed.
                    (Q) An analysis of the collaboration of medical 
                centers of the Department with medical examiners' 
                offices or local jurisdictions to determine veteran 
                mortality and cause of death.
                    (R) An identification and determination of a best 
                practice model to collect and share veteran death 
                certificate data between the Department of Veterans 
                Affairs, the Department of Defense, States, and tribal 
                entities.
                    (S) A description of how data relating to death 
                certificates of veterans is collected, determined, and 
                reported by the Department of Veterans Affairs.
                    (T) An assessment of any patterns apparent to the 
                National Academies of Sciences, Engineering, and 
                Medicine based on the review conducted under paragraph 
                (1).
                    (U) Such recommendations for further action that 
                would improve the safety and well-being of veterans as 
                the National Academies of Sciences, Engineering, and 
                Medicine determine appropriate.
            (3) Compilation of data.--
                    (A) Form of compilation.--The Secretary of Veterans 
                Affairs shall ensure that data compiled under paragraph 
                (2) is compiled in a manner that allows it to be 
                analyzed across all data fields for purposes of 
                informing and updating clinical practice guidelines of 
                the Department of Veterans Affairs.
                    (B) Compilation of data regarding covered 
                veterans.--In compiling data under paragraph (2) 
                regarding covered veterans described in subparagraphs 
                (A) through (C) of such paragraph, data regarding 
                veterans described in each such subparagraph shall be 
                compiled separately and disaggregated by year.
            (4) Completion of review and report.--The agreement entered 
        into under paragraph (1) shall require that the National 
        Academies of Sciences, Engineering, and Medicine complete the 
        review under such paragraph and submit to the Secretary of 
        Veterans Affairs a report containing the results of the review 
        not later than 180 days after entering into the agreement.
    (b) Report.--Not later than 30 days after the completion by the 
National Academies of Sciences, Engineering, and Medicine of the review 
required under subsection (a), the Secretary of Veterans Affairs 
shall--
            (1) submit to the Committee on Veterans' Affairs of the 
        Senate and the Committee on Veterans' Affairs of the House of 
        Representatives a report on the results of the review; and
            (2) make such report publicly available.
    (c) Definitions.--In this section:
            (1) The term ``black box warning'' means a warning 
        displayed on the label of a prescription drug that is designed 
        to call attention to the serious or life-threatening risk of 
        the prescription drug.
            (2) The term ``covered veteran'' means a veteran who 
        received hospital care or medical services furnished by the 
        Department of Veterans Affairs during the five-year period 
        preceding the death of the veteran.
            (3) The term ``first-line treatment'' means a potential 
        intervention that has been evaluated and assigned a high score 
        within clinical practice guidelines.
            (4) The term ``State'' means each of the States, 
        territories, and possessions of the United States, the District 
        of Columbia, and the Commonwealth of Puerto Rico.

SEC. 5. AMENDMENT RELATING TO THE ACCOUNT FOR THE STATE RESPONSE TO THE 
              OPIOID ABUSE CRISIS.

    Section 1003 of the 21st Century Cures Act (Public Law 114-255; 42 
U.S.C. 290ee-3 note) is amended in subsection (b)(3), by adding at the 
end the following new subparagraph:
                    ``(C) Appropriations after fiscal year 2018.--There 
                is authorized to be appropriated, and there is 
                appropriated, out of any monies in the Treasury not 
                otherwise appropriated, to the Account For the State 
                Response to the Opioid Abuse Crisis $500,000,000 for 
                each of fiscal years 2019 through 2023.''.

SEC. 6. MENTAL HEALTH ACCESS IMPROVEMENT.

    (a) Coverage of Services.--
            (1) In general.--Section 1861(s)(2) of the Social Security 
        Act (42 U.S.C. 1395x(s)(2)) is amended--
                    (A) in subparagraph (FF), by striking ``and'' after 
                the semicolon at the end;
                    (B) in subparagraph (GG), by inserting ``and'' 
                after the semicolon at the end; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(HH) marriage and family therapist services (as defined 
        in subsection (jjj)(1)) and mental health counselor services 
        (as defined in subsection (jjj)(3));''.
            (2) Definitions.--Section 1861 of the Social Security Act 
        (42 U.S.C. 1395x) is amended by adding at the end the following 
        new subsection:

     ``Marriage and Family Therapist Services; Marriage and Family 
  Therapist; Mental Health Counselor Services; Mental Health Counselor

    ``(jjj)(1) The term `marriage and family therapist services' means 
services performed by a marriage and family therapist (as defined in 
paragraph (2)) for the diagnosis and treatment of mental illnesses, 
which the marriage and family therapist is legally authorized to 
perform under State law (or the State regulatory mechanism provided by 
State law) of the State in which such services are performed, as would 
otherwise be covered if furnished by a physician or as an incident to a 
physician's professional service, but only if no facility or other 
provider charges or is paid any amounts with respect to the furnishing 
of such services.
    ``(2) The term `marriage and family therapist' means an individual 
who--
            ``(A) possesses a master's or doctoral degree which 
        qualifies for licensure or certification as a marriage and 
        family therapist pursuant to State law;
            ``(B) after obtaining such degree has performed at least 2 
        years of clinical supervised experience in marriage and family 
        therapy; and
            ``(C) in the case of an individual performing services in a 
        State that provides for licensure or certification of marriage 
        and family therapists, is licensed or certified as a marriage 
        and family therapist in such State.
    ``(3) The term `mental health counselor services' means services 
performed by a mental health counselor (as defined in paragraph (4)) 
for the diagnosis and treatment of mental illnesses which the mental 
health counselor is legally authorized to perform under State law (or 
the State regulatory mechanism provided by the State law) of the State 
in which such services are performed, as would otherwise be covered if 
furnished by a physician or as incident to a physician's professional 
service, but only if no facility or other provider charges or is paid 
any amounts with respect to the furnishing of such services.
    ``(4) The term `mental health counselor' means an individual who--
            ``(A) possesses a master's or doctor's degree in mental 
        health counseling or a related field;
            ``(B) after obtaining such a degree has performed at least 
        2 years of supervised mental health counselor practice; and
            ``(C) in the case of an individual performing services in a 
        State that provides for licensure or certification of mental 
        health counselors or professional counselors, is licensed or 
        certified as a mental health counselor or professional 
        counselor in such State.''.
            (3) Provision for payment under part b.--Section 
        1832(a)(2)(B) of the Social Security Act (42 U.S.C. 
        1395k(a)(2)(B)) is amended by adding at the end the following 
        new clause:
                            ``(v) marriage and family therapist 
                        services (as defined in section 1861(jjj)(1)) 
                        and mental health counselor services (as 
                        defined in section 1861(jjj)(3));''.
            (4) Amount of payment.--Section 1833(a)(1) of the Social 
        Security Act (42 U.S.C. 1395l(a)(1)) is amended--
                    (A) by striking ``and (BB)'' and inserting 
                ``(BB)''; and
                    (B) by inserting before the semicolon at the end 
                the following: ``, and (CC) with respect to marriage 
                and family therapist services and mental health 
                counselor services under section 1861(s)(2)(HH), the 
                amounts paid shall be 80 percent of the lesser of the 
                actual charge for the services or 75 percent of the 
                amount determined for payment of a psychologist under 
                subparagraph (L)''.
            (5) Exclusion of marriage and family therapist services and 
        mental health counselor services from skilled nursing facility 
        prospective payment system.--Section 1888(e)(2)(A)(ii) of the 
        Social Security Act (42 U.S.C. 1395yy(e)(2)(A)(ii)) is amended 
        by inserting ``marriage and family therapist services (as 
        defined in section 1861(jjj)(1)), mental health counselor 
        services (as defined in section 1861(jjj)(3)),'' after 
        ``qualified psychologist services,''.
            (6) Inclusion of marriage and family therapists and mental 
        health counselors as practitioners for assignment of claims.--
        Section 1842(b)(18)(C) of the Social Security Act (42 U.S.C. 
        1395u(b)(18)(C)) is amended by adding at the end the following 
        new clauses:
            ``(vii) A marriage and family therapist (as defined in 
        section 1861(jjj)(2)).
            ``(viii) A mental health counselor (as defined in section 
        1861(jjj)(4)).''.
    (b) Coverage of Certain Mental Health Services Provided in Certain 
Settings.--
            (1) Rural health clinics and federally qualified health 
        centers.--Section 1861(aa)(1)(B) of the Social Security Act (42 
        U.S.C. 1395x(aa)(1)(B)) is amended by striking ``or by a 
        clinical social worker (as defined in subsection (hh)(1))'' and 
        inserting ``, by a clinical social worker (as defined in 
        subsection (hh)(1)), by a marriage and family therapist (as 
        defined in subsection (jjj)(2)), or by a mental health 
        counselor (as defined in subsection (jjj)(4))''.
            (2) Hospice programs.--Section 1861(dd)(2)(B)(i)(III) of 
        the Social Security Act (42 U.S.C. 1395x(dd)(2)(B)(i)(III)) is 
        amended by inserting ``, marriage and family therapist, or 
        mental health counselor'' after ``social worker''.
    (c) Authorization of Marriage and Family Therapists and Mental 
Health Counselors To Develop Discharge Plans for Post-Hospital 
Services.--Section 1861(ee)(2)(G) of the Social Security Act (42 U.S.C. 
1395x(ee)(2)(G)) is amended by inserting ``, including a marriage and 
family therapist and a mental health counselor who meets qualification 
standards established by the Secretary'' before the period at the end.
    (d) Effective Date.--The amendments made by this section shall 
apply with respect to services furnished on or after January 1, 2019.

SEC. 7. SYNTHETICS TRAFFICKING AND OVERDOSE PREVENTION.

    (a) Formal Entry Requirements--Postal Service as Consignee.--
Subparagraph (B) of section 484(a)(2) of the Tariff Act of 1930 (19 
U.S.C. 1484(a)(2)(B)) is amended to read as follows:
            ``(B)(i) When an entry of merchandise is made under this 
        section, the required documentation or information shall be 
        filed or electronically transmitted--
                    ``(I) by the owner or purchaser of the merchandise; 
                or
                    ``(II) when appropriately designated by the owner, 
                purchaser, or consignee of the merchandise, by a person 
                holding a valid license under section 641.
            ``(ii) The Postmaster General shall be deemed the consignee 
        for merchandise, as defined by section 498(c), imported through 
        the mail, and the Postmaster General shall, at the Postmaster 
        General's sole expense, designate a person holding a valid 
        license under section 641 to file the required documentation or 
        information or ensure that the owner or purchaser of the 
        merchandise or a person holding a valid license under section 
        641 that is designated by the owner or purchaser files the 
        required documentation or information.
            ``(iii) When a consignee declares on entry that he or she 
        is the owner or purchaser of merchandise, U.S. Customs and 
        Border Protection may, without liability, accept the 
        declaration.
            ``(iv) For the purposes of this Act, the importer of record 
        must be one of the parties who is eligible to file the 
        documentation or information required by this section.''.
    (b) Informal Entries.--Section 498 of the Tariff Act of 1930 (19 
U.S.C. 1498) is amended by adding at the end the following:
    ``(c) Application to Postal Shipments.--
            ``(1) Definitions.--In this subsection:
                    ``(A) Document.--The term `document' means a piece 
                of written, drawn, printed, or digital information, 
                excluding objects of merchandise, that--
                            ``(i) is conveyed in an envelope that is 
                        less than or equal to 165 millimeters in width, 
                        245 millimeters in length, and 5 millimeters in 
                        depth; and
                            ``(ii) weighs 100 grams or less when 
                        conveyed.
                    ``(B) Merchandise.--The term `merchandise' has the 
                same meaning as that term is defined in section 401 but 
                does not include a document.
            ``(2) Requirement.--Notwithstanding any other provision of 
        law, for merchandise meeting the requirements of subsection 
        (a), the Postmaster General shall comply with the entry 
        requirements of section 484.
            ``(3) Regulations.--Any regulation issued pursuant to this 
        subsection shall apply identical entry procedures for 
        merchandise imported through the mail as are applied for 
        merchandise imported via a private carrier.''.
    (c) De Minimis Shipments.--Section 321 of the Tariff Act of 1930 
(19 U.S.C. 1321) is amended by adding at the end the following:
    ``(c)(1) For imported articles that qualify for the administrative 
exemption under subsection (a)(2) and that arrive at international mail 
facilities in the United States, the Postmaster General shall be deemed 
the consignee for such articles that are considered merchandise, as the 
term is defined in section 498(c).
    ``(2) In addition to the parties that are authorized to comply with 
the entry requirements of sections 498 and 484, the Postmaster General, 
as a consignee, may, using reasonable care, enter such merchandise that 
qualifies for the administrative exemption under subsection (a)(2).''.
    (d) Customs Fees.--
            (1) In general.--Paragraph (6) of section 13031(a) of the 
        Consolidated Omnibus Budget Reconciliation Act of 1985 (19 
        U.S.C. 58c(a)(6)) is amended to read as follows:
            ``(6)(A) For the arrival of shipments of merchandise (as 
        the term is defined in section 498(c) of the Trade Act of 1930) 
        or any other item that is valued at $2,000 or less (or such 
        higher amount as the Secretary of the Treasury may set by 
        regulation pursuant to section 498 of the Tariff Act of 1930 
        (19 U.S.C. 1498) and subject to adjustment under subsection 
        (l)) arriving at an international mail facility:
                    ``(i) $1 per individual airway bill or bill of 
                lading (subject to adjustment under subsection (l)); or
                    ``(ii) if such merchandise is formally entered, the 
                fee provided for in paragraph (9), if applicable.
            ``(B) Notwithstanding section 451 of the Tariff Act of 1930 
        (19 U.S.C. 1451), the payment required by subparagraph (A) 
        shall be the only payment required for reimbursement of U.S. 
        Customs and Border Protection in connection with the processing 
        of an individual airway bill or bill of lading in accordance 
        with such subparagraph and for providing services at 
        international mail facilities, except that U.S. Customs and 
        Border Protection may require such facilities to cover expenses 
        of the agency for adequate office space, equipment, 
        furnishings, supplies, and security.
            ``(C) The payment required by subparagraphs (A) and (B) 
        shall be paid on a quarterly basis by the Postmaster General in 
        accordance with regulations prescribed by the Secretary of the 
        Treasury. The payments shall be allocated as follows:
                    ``(i) 50 percent of the amount of payments received 
                in this paragraph shall, in accordance with section 524 
                of the Tariff Act of 1930 (19 U.S.C. 1524), be 
                deposited in the Customs User Fee Account and shall be 
                used to directly reimburse each appropriation for the 
                amount paid out of that appropriation for the costs 
                incurred in providing services to international mail 
                facilities. Amounts deposited in accordance with the 
                preceding sentence shall be available until expended 
                for the provision of customs services to international 
                mail facilities.
                    ``(ii) Notwithstanding section 524 of the Tariff 
                Act of 1930 (19 U.S.C. 1524), 50 percent of the amount 
                of payments received under this paragraph shall be paid 
                to the Secretary of the Treasury, which is in lieu of 
                the payment of fees under paragraph (10).''.
            (2) Technical amendments.--Paragraph (10) of section 
        13031(a) of the Consolidated Omnibus Budget Reconciliation Act 
        of 1985 (19 U.S.C. 58c(a)(10)) is amended--
                    (A) by striking ``or'' in subparagraph (B);
                    (B) by striking the period at the end of 
                subparagraph (C)(iii) and inserting a comma and ``or'';
                    (C) by inserting after subparagraph (C)(iii) the 
                following:
                    ``(D) an international mail facility.''; and
                    (D) in the undesignated material at the end by 
                striking the period and inserting ``or referred to in 
                subparagraph (D) see paragraph (6).''.
    (e) Mandatory Advanced Electronic Information for Postal 
Shipments.--Subparagraph (K) of section 343(a)(3) of the Trade Act of 
2002 (Public Law 107-210; 19 U.S.C. 2071 note) is amended to read as 
follows:
                    ``(K) The Secretary shall require the Postmaster 
                General to transmit or to ensure the transmission of 
                the information required in paragraphs (1) and (2) to 
                U.S. Customs and Border Protection for all shipments by 
                the United States Postal Service which includes 
                shipments that the United States Postal Service 
                receives from foreign postal operators (shipments from 
                foreign postal operators may be transported by private 
                carriers). All regulations issued pursuant to this 
                provision are required to impose the same information 
                requirements on the United States Postal Service and 
                private carriers.''.
    (f) Manifest Penalties Applied to the United States Postal 
Service.--
            (1) Penalties for violations of the arrival, reporting, 
        entry, and clearance requirements.--Section 436 of the Tariff 
        Act of 1930 (19 U.S.C. 1436) is amended by adding at the end 
        the following new subsection:
    ``(e) Civil Penalties Arising From Violations for Postal 
Shipments.--With respect to civil penalties provided for in subsections 
(b) and (d), the Postmaster General shall be liable for the penalty if 
the violation was caused by a foreign postal operator or the United 
States Postal Service.''.
            (2) Penalties for falsity or lack of manifest.--Section 584 
        of the Tariff Act of 1930 (19 U.S.C. 1584) is amended by adding 
        at the end the following new subsection:
    ``(c) Person Directly or Indirectly Responsible Shall Include the 
Postmaster General.--For purposes of subsection (a), the Postmaster 
General may be the person directly or indirectly responsible for a 
discrepancy if the discrepancy is the result of--
            ``(1) an omission by a foreign postal operator or the 
        United States Postal Service; or
            ``(2) false information regarding the shipment that was 
        provided to the carrier by a foreign postal operator or the 
        United States Postal Service.''.
    (g) Limitation on International Postal Arrangements.--
            (1) Existing agreements.--
                    (A) In general.--In the event that any provision in 
                this section is found to be in violation of obligations 
                of the United States under the Universal Postal Union, 
                the Secretary of State shall negotiate to amend the 
                relevant provisions of the agreement so that the United 
                States is no longer in violation of the agreement.
                    (B) Construction.--Nothing in this subsection may 
                be construed to require or permit any delay in the 
                implementation of this section.
            (2) Future agreements.--The Secretary of State may not 
        conclude any international postal arrangement pursuant to the 
        authority set out in section 407 of title 39, United States 
        Code, that is inconsistent with this section or any amendment 
        made by this section.
    (h) Application of Other Customs Laws.--
            (1) In general.--U.S. Customs and Border Protection shall 
        ensure that all merchandise, as that term is defined in 
        subsection (c) of section 498 of the Tariff Act of 1930 (19 
        U.S.C. 1498), imported to the United States through the mail 
        shall be subject to the same import procedures, legal 
        restrictions, and certifications as merchandise imported by 
        private carriers.
            (2) Regulations.--The Secretary of the Treasury shall issue 
        regulations pursuant to this section to ensure that merchandise 
        imported through the mail is in accordance with Federal law.
    (i) Cost Recoupment.--The Postmaster General shall ensure that all 
costs associated with complying with this section, as well as all 
penalties assessed against the Postmaster General, are charged directly 
to foreign shippers, foreign postal operators, or United States 
ultimate consignees.
    (j) Effective Date; Regulations.--
            (1) Effective date.--This section shall become effective 
        upon the date of the enactment of this Act.
            (2) Regulations.--Not later than 1 year after the date of 
        the enactment of this Act, the Secretary shall prescribe all 
        regulations required under this section.

SEC. 8. STOP THE IMPORTATION AND TRAFFICKING OF SYNTHETIC ANALOGUES.

    (a) Establishment of Schedule A.--Section 202 of the Controlled 
Substances Act (21 U.S.C. 812) is amended--
            (1) in subsection (a), by striking ``five schedules of 
        controlled substances, to be known as schedules I, II, III, IV, 
        and V'' and inserting ``six schedules of controlled substances, 
        to be known as schedules I, II, III, IV, V, and A'';
            (2) in subsection (b), by adding at the end the following:
    ``(6) Schedule A.--
            ``(A) In general.--The drug or substance--
                    ``(i) has--
                            ``(I) a chemical structure that is 
                        substantially similar to the chemical structure 
                        of a controlled substance in schedule I, II, 
                        III, IV, or V; and
                            ``(II) an actual or predicted stimulant, 
                        depressant, or hallucinogenic effect on the 
                        central nervous system that is substantially 
                        similar to or greater than the stimulant, 
                        depressant, or hallucinogenic effect on the 
                        central nervous system of a controlled 
                        substance in schedule I, II, III, IV, or V; and
                    ``(ii) is not--
                            ``(I) listed or otherwise included in any 
                        other schedule in this section or by regulation 
                        of the Attorney General; and
                            ``(II) with respect to a particular person, 
                        subject to an exemption that is in effect for 
                        investigational use, for that person, under 
                        section 505 of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 355) to the extent 
                        conduct with respect to such substance is 
                        pursuant to such exemption.
            ``(B) Predicted stimulant, depressant, or hallucinogenic 
        effect.--For purpose of this paragraph, a predicted stimulant, 
        depressant, or hallucinogenic effect on the central nervous 
        system may be based on--
                    ``(i) the chemical structure, structure activity 
                relationships, binding receptor assays, or other 
                relevant scientific information about the substance;
                    ``(ii)(I) the current or relative potential for 
                abuse of the substance; and
                    ``(II) the clandestine importation, manufacture, or 
                distribution, or diversion from legitimate channels, of 
                the substance; or
                    ``(iii) the capacity of the substance to cause a 
                state of dependence, including physical or 
                psychological dependence that is similar to or greater 
                than that of a controlled substance in schedule I, II, 
                III, IV, or V.''; and
            (3) in subsection (c)--
                    (A) in the matter preceding schedule I, by striking 
                ``IV, and V'' and inserting ``IV, V, and A''; and
                    (B) by adding at the end the following:

                              ``schedule a

    ``(a) Unless specifically excepted or unless listed in another 
schedule, any of the following substances, as scheduled in accordance 
with section 201(k)(5):
            ``(1) 4-fluoroisobutyryl fentanyl.
            ``(2) Valeryl fentanyl.
            ``(3) 4-methoxybutyryl fentanyl.
            ``(4) 4-methylphenethyl acetyl fentanyl.
            ``(5) 3-furanyl fentanyl.
            ``(6) Ortho-fluorofentanyl.
            ``(7) Tetrahydrofuranyl fentanyl.
            ``(8) Ocfentanil.
            ``(9) 4-fluorobutyryl fentanyl.
            ``(10) Methoxyacetyl fentanyl.
            ``(11) Meta-fluorofentanyl.
            ``(12) Isobutyryl fentanyl.
            ``(13) Acryl fentanyl.''.
    (b) Temporary and Permanent Scheduling of Schedule A Substances.--
Section 201 of the Controlled Substances Act (21 U.S.C. 811) is amended 
by adding at the end the following:
    ``(k) Temporary and Permanent Scheduling of Schedule A 
Substances.--
            ``(1) The Attorney General may issue a temporary order 
        adding a drug or substance to schedule A if the Attorney 
        General finds that--
                    ``(A) the drug or other substance satisfies the 
                criteria for being considered a schedule A substance; 
                and
                    ``(B) adding such drug or substance to schedule A 
                will assist in preventing abuse or misuse of the drug 
                or other substance.
            ``(2) A temporary scheduling order issued under paragraph 
        (1) shall not take effect until 30 days after the date of the 
        publication by the Attorney General of a notice in the Federal 
        Register of the intention to issue such order and the grounds 
        upon which such order is to be issued. The temporary scheduling 
        order shall expire not later than 5 years after the date it 
        becomes effective, except that the Attorney General may, during 
        the pendency of proceedings under paragraph (5), extend the 
        temporary scheduling order for up to 180 days.
            ``(3) A temporary scheduling order issued under paragraph 
        (1) shall be vacated upon the issuance of a permanent order 
        issued under paragraph (5) with regard to the same substance, 
        or upon the subsequent issuance of any scheduling order under 
        this section.
            ``(4) A temporary scheduling order issued under paragraph 
        (1) shall not be subject to judicial review.
            ``(5) The Attorney General may, by rule, issue a permanent 
        order adding a drug or other substance to schedule A if such 
        drug or substance satisfies the criteria for being considered a 
        schedule A substance. Such rulemaking may be commenced 
        simultaneously with the issuance of the temporary scheduling 
        order issued under paragraph (1) with regard to the same 
        substance.
            ``(6) Before initiating proceedings under paragraph (1) or 
        (5), the Attorney General shall transmit notice of an order 
        proposed to be issued to the Secretary of Health and Human 
        Services. In issuing an order under paragraph (1) or (5), the 
        Attorney General shall take into consideration any comments 
        submitted by the Secretary of Health and Human Services in 
        response to a notice transmitted pursuant to this paragraph.
            ``(7) On the date of the publication of a notice in the 
        Federal Register pursuant to paragraph (2), the Attorney 
        General shall transmit the same notice to Congress. The 
        temporary scheduling order shall take effect according to 
        paragraph (2), except that the temporary scheduling order may 
        be disapproved by Act of Congress within 180 days from the date 
        of publication of the notice in the Federal Register.''.
    (c) Penalties.--
            (1) Controlled substances act.--The Controlled Substances 
        Act (21 U.S.C. 801 et seq.) is amended--
                    (A) in section 401(b)(1) (21 U.S.C. 841(b)(1)), by 
                adding at the end the following:
    ``(F)(i) In the case of any controlled substance in schedule A, 
such person shall be sentenced to a term of imprisonment of not more 
than 10 years and if death or serious bodily injury results from the 
use of such substance shall be sentenced to a term of imprisonment of 
not more than 15 years, a fine not to exceed the greater of that 
authorized in accordance with the provisions of title 18, United States 
Code, or $500,000 if the defendant is an individual or $2,500,000 if 
the defendant is other than an individual, or both.
    ``(ii) If any person commits such a violation after a prior 
conviction for a felony drug offense has become final, such person 
shall be sentenced to a term of imprisonment of not more than 20 years 
and if death or serious bodily injury results from the use of such 
substance shall be sentenced to a term of imprisonment of not more than 
30 years, a fine not to exceed the greater of twice that authorized in 
accordance with the provisions of title 18, United States Code, or 
$1,000,000 if the defendant is an individual or $5,000,000 if the 
defendant is other than an individual, or both.
    ``(iii) Any sentence imposing a term of imprisonment under this 
subparagraph shall, in the absence of such a prior conviction, impose a 
term of supervised release of not less than 2 years in addition to such 
term of imprisonment and shall, if there was such a prior conviction, 
impose a term of supervised release of not less than 4 years in 
addition to such term of imprisonment.'';
                    (B) in section 403(a) (21 U.S.C. 843(a))--
                            (i) in paragraph (8), by striking ``or'' at 
                        the end;
                            (ii) in paragraph (9), by striking the 
                        period at the end and inserting ``; or''; and
                            (iii) by inserting after paragraph (9) the 
                        following:
            ``(10) to export a substance in violation of the controlled 
        substance laws of the country to which the substance is 
        exported.''; and
                    (C) in section 404 (21 U.S.C. 844), by inserting 
                after subsection (a) the following:
    ``(b) A person shall not be subject to a criminal or civil penalty 
under this title or under any other Federal law solely for possession 
of a schedule A controlled substance.''.
            (2) Controlled substances import and export act.--Section 
        1010(b) of the Controlled Substances Import and Export Act (21 
        U.S.C. 960(b)) is amended by adding at the end the following:
    ``(8) In the case of a violation under subsection (a) involving a 
controlled substance in schedule A, the person committing such 
violation shall be sentenced to a term of imprisonment of not more than 
20 years and if death or serious bodily injury results from the use of 
such substance shall be sentenced to a term of imprisonment of not more 
than life, a fine not to exceed the greater of that authorized in 
accordance with the provisions of title 18, United States Code, or 
$1,000,000 if the defendant is an individual or $5,000,000 if the 
defendant is other than an individual, or both. If any person commits 
such a violation after a prior conviction for a felony drug offense has 
become final, such person shall be sentenced to a term of imprisonment 
of not more than 30 years and if death or serious bodily injury results 
from the use of such substance shall be sentenced to not more than life 
imprisonment, a fine not to exceed the greater of twice that authorized 
in accordance with the provisions of title 18, United States Code, or 
$2,000,000 if the defendant is an individual or $10,000,000 if the 
defendant is other than an individual, or both. Notwithstanding section 
3583 of title 18, United States Code, any sentence imposing a term of 
imprisonment under this paragraph shall, in the absence of such a prior 
conviction, impose a term of supervised release of not less than 3 
years in addition to such term of imprisonment and shall, if there was 
such a prior conviction, impose a term of supervised release of not 
less than 6 years in addition to such term of imprisonment. 
Notwithstanding the prior sentence, and notwithstanding any other 
provision of law, the court shall not place on probation or suspend the 
sentence of any person sentenced under the provisions of this paragraph 
which provide for a mandatory term of imprisonment if death or serious 
bodily injury results.''.
    (d) False Labeling of Schedule A Controlled Substances.--
            (1) In general.--Section 305 of the Controlled Substances 
        Act (21 U.S.C. 825) is amended by adding at the end the 
        following:
    ``(f) False Labeling of Schedule A Controlled Substances.--
            ``(1) It shall be unlawful to import, export, manufacture, 
        distribute, dispense, or possess with intent to manufacture, 
        distribute, or dispense, a schedule A substance or product 
        containing a schedule A substance, unless the substance or 
        product bears a label clearly identifying a schedule A 
        substance or product containing a schedule A substance by the 
        nomenclature used by the International Union of Pure and 
        Applied Chemistry (IUPAC).
            ``(2)(A) A product described in subparagraph (B) is exempt 
        from the International Union of Pure and Applied Chemistry 
        nomenclature requirement of this subsection if such product is 
        labeled in the manner required under the Federal Food, Drug, 
        and Cosmetic Act.
            ``(B) A product is described in this subparagraph if the 
        product--
                    ``(i) is the subject of an approved application as 
                described in section 505(b) or (j) of the Federal Food, 
                Drug, and Cosmetic Act; or
                    ``(ii) is exempt from the provisions of section 505 
                of such Act relating to new drugs because--
                            ``(I) it is intended solely for 
                        investigational use as described in section 
                        505(i) of such Act; and
                            ``(II) such product is being used 
                        exclusively for purposes of a clinical trial 
                        that is the subject of an effective 
                        investigational new drug application.''.
            (2) Penalties.--Section 402 of the Controlled Substances 
        Act (21 U.S.C. 842) is amended--
                    (A) in subsection (a)(16), by inserting ``or 
                subsection (f)'' after ``subsection (e)''; and
                    (B) in subsection (c)(1)(D), by inserting ``or a 
                schedule A substance'' after ``anabolic steroid''.
    (e) Registration Requirements for Handlers of Schedule A 
Substances.--
            (1) Controlled substances act.--Section 303 of the 
        Controlled Substances Act (21 U.S.C. 823) is amended by adding 
        at the end the following:
    ``(k)(1) The Attorney General shall register an applicant to 
manufacture schedule A substances if--
            ``(A) the applicant demonstrates that the schedule A 
        substances will be used for research, analytical, or industrial 
        purposes approved by the Attorney General; and
            ``(B) the Attorney General determines that such 
        registration is consistent with the public interest and with 
        the United States obligations under international treaties, 
        conventions, or protocols in effect on the date of enactment of 
        this subsection.
    ``(2) In determining the public interest under paragraph (1)(B), 
the Attorney General shall consider--
            ``(A) maintenance of effective controls against diversion 
        of particular controlled substances and any controlled 
        substance in schedule A compounded therefrom into other than 
        legitimate medical, scientific, research, or industrial 
        channels, by limiting the importation and bulk manufacture of 
        such controlled substances to a number of establishments which 
        can produce an adequate and uninterrupted supply of these 
        substances under adequately competitive conditions for 
        legitimate medical, scientific, research, and industrial 
        purposes;
            ``(B) compliance with applicable State and local law;
            ``(C) promotion of technical advances in the art of 
        manufacturing substances described in subparagraph (A) and the 
        development of new substances;
            ``(D) prior conviction record of applicant under Federal 
        and State laws relating to the manufacture, distribution, or 
        dispensing of substances described in paragraph (A);
            ``(E) past experience in the manufacture of controlled 
        substances, and the existence in the establishment of effective 
        control against diversion; and
            ``(F) such other factors as may be relevant to and 
        consistent with the public health and safety.
    ``(3) If an applicant is registered to manufacture controlled 
substances in schedule I or II under subsection (a), the applicant 
shall not be required to apply for a separate registration under this 
subsection.
    ``(l)(1) The Attorney General shall register an applicant to 
distribute schedule A substances--
            ``(A) if the applicant demonstrates that the schedule A 
        substances will be used for research, analytical, or industrial 
        purposes approved by the Attorney General; and
            ``(B) unless the Attorney General determines that the 
        issuance of such registration is inconsistent with the public 
        interest.
    ``(2) In determining the public interest under paragraph (1)(B), 
the Attorney General shall consider--
            ``(A) maintenance of effective control against diversion of 
        particular controlled substances into other than legitimate 
        medical, scientific, and industrial channels;
            ``(B) compliance with applicable State and local law;
            ``(C) prior conviction record of applicant under Federal or 
        State laws relating to the manufacture, distribution, or 
        dispensing of substances described in subparagraph (A);
            ``(D) past experience in the distribution of controlled 
        substances; and
            ``(E) such other factors as may be relevant to and 
        consistent with the public health and safety.
    ``(3) If an applicant is registered to distribute a controlled 
substance in schedule I or II under subsection (b), the applicant shall 
not be required to apply for a separate registration under this 
subsection.
    ``(m)(1) Not later than 90 days after the date on which a substance 
is placed in schedule A, any practitioner who was engaged in research 
on the substance before the placement of the substance in schedule A 
and any manufacturer or distributor who was handling the substance 
before the placement of the substance in schedule A shall register with 
the Attorney General.
    ``(2)(A) Not later than 60 days after the date on which the 
Attorney General receives an application for registration to conduct 
research on a schedule A substance, the Attorney General shall--
            ``(i) grant, or initiate proceedings under section 304(c) 
        to deny, the application; or
            ``(ii) request supplemental information from the applicant.
    ``(B) Not later than 30 days after the date on which the Attorney 
General receives supplemental information requested under subparagraph 
(A)(ii) in connection with an application described in subparagraph 
(A), the Attorney General shall grant or deny the application.
    ``(n)(1) The Attorney General shall register a scientific 
investigator or a qualified research institution to conduct research 
with controlled substances in schedule A in accordance with this 
subsection. In evaluating applications for such registration, the 
Attorney General shall apply the criteria set forth in subsection (f) 
of this section that apply to practitioners seeking a registration to 
conduct research with a schedule I controlled substance, except that 
the applicant shall not be required to submit a research protocol.
    ``(2) If the applicant is not currently registered under subsection 
(f) to conduct research with a schedule I controlled substance, the 
Attorney General shall refer the application to the Secretary, who 
shall determine whether the applicant will be engaged in bona fide 
research and is qualified to conduct such research.
    ``(3) If the applicant is currently registered under subsection (f) 
to conduct research with a schedule I controlled substance, the 
applicant will be considered qualified to conduct research with 
controlled substances in schedule A and the Attorney General shall 
modify the applicant's registration to include schedule A controlled 
substances in accordance with this paragraph. The applicant shall 
notify the Attorney General of his intent to conduct research with a 
controlled substance in schedule A. Upon receiving such notification, 
the Attorney General shall modify the practitioner's existing 
registration to authorize research with schedule A controlled 
substances, unless the Attorney General determines that the 
registration modification would be inconsistent with the public 
interest based on the criteria of subsection (f).
    ``(4) Registrations issued under this subsection to a qualified 
research institution will apply to all agents and employees of that 
institution acting within the scope of their professional practice.
    ``(5) At least thirty days prior to conducting any research with a 
controlled substance in schedule A, the registrant shall provide the 
Attorney General with written notification of the following:
            ``(A) The name of and drug code for each substance.
            ``(B) The name of each individual with access to each 
        substance.
            ``(C) The amount of each substance.
            ``(D) Other similar information the Attorney General may 
        require.
    ``(6) The quantity of a schedule A controlled substance possessed 
by a person registered under this subsection shall be appropriate for 
the research being conducted, subject to the additional limitations set 
forth in this paragraph. To reduce the risk of diversion, the Attorney 
General may establish limitations on the quantity of schedule A 
controlled substances that may be manufactured or possessed for 
purposes of research under this subsection and shall publish such 
limitations on the website of the Drug Enforcement Administration. A 
person registered under this subsection may, based on legitimate 
research needs, apply to the Attorney General to manufacture or possess 
an amount greater than that so specified by the Attorney General. The 
Attorney General shall specify the manner in which such applications 
shall be submitted. The Attorney General shall act on an application 
filed under this subparagraph within 30 days of receipt of such 
application. If the Attorney General fails to act within 30 days, the 
registrant shall be allowed to manufacture and possess up to the amount 
requested. The Attorney General shall have the authority to reverse the 
increase for cause.
    ``(7) The Attorney General shall by regulation specify the manner 
in which applications for registration under this subsection shall be 
submitted.
    ``(8) Registrants authorized under this subsection may manufacture 
and possess schedule A controlled substances up to the approved amounts 
only for use in their own research setting or institution. 
Manufacturing for use in any other setting or institution shall require 
a manufacturer's registration under section 303(a).''.
            (2) Controlled substances import and export act.--Section 
        1008 of the Controlled Substances Import and Export Act (21 
        U.S.C. 958) is amended by adding at the end the following:
    ``(j)(1) The Attorney General shall register an applicant to import 
or export a schedule A substance if--
            ``(A) the applicant demonstrates that the schedule A 
        substances will be used for research, analytical, or industrial 
        purposes approved by the Attorney General; and
            ``(B) the Attorney General determines that such 
        registration is consistent with the public interest and with 
        the United States obligations under international treaties, 
        conventions, or protocols in effect on the date of enactment of 
        this subsection.
    ``(2) In determining the public interest under paragraph (1)(B), 
the Attorney General shall consider the factors described in 
subparagraphs (A) through (F) of section 303(k)(2).
    ``(3) If an applicant is registered to import or export a 
controlled substance in schedule I or II under subsection (a), the 
applicant shall not be required to apply for a separate registration 
under this subsection.''.
    (f) Additional Conforming Amendments.--
            (1) Controlled substances act.--The Controlled Substances 
        Act (21 U.S.C. 801 et seq.) is amended--
                    (A) in section 303(c) (21 U.S.C. 823(c))--
                            (i) by striking ``subsections (a) and (b)'' 
                        and inserting ``subsection (a), (b), (k), or 
                        (l)''; and
                            (ii) by striking ``schedule I or II'' and 
                        inserting ``schedule I, II, or A'';
                    (B) in section 306 (21 U.S.C. 826)--
                            (i) in subsection (a), in the first 
                        sentence, by striking ``schedules I and II'' 
                        and inserting ``schedules I, II, and A'';
                            (ii) in subsection (b), in the second 
                        sentence, by striking ``schedule I or II'' and 
                        inserting ``schedule I, II, or A'';
                            (iii) in subsection (c), in the first 
                        sentence, by striking ``schedules I and II'' 
                        and inserting ``schedules I, II, and A'';
                            (iv) in subsection (d), in the first 
                        sentence, by striking ``schedule I or II'' and 
                        inserting ``schedule I, II, or A'';
                            (v) in subsection (e), in the first 
                        sentence, by striking ``schedule I or II'' and 
                        inserting ``schedule I, II, or A''; and
                            (vi) in subsection (f), in the first 
                        sentence, by striking ``schedules I and II'' 
                        and inserting ``schedules I, II, and A'';
                    (C) in section 308(a) (21 U.S.C. 828(a)), by 
                striking ``schedule I or II'' and inserting ``schedule 
                I, II, or A'';
                    (D) in section 402(b) (21 U.S.C. 842(b)), in the 
                matter preceding paragraph (1), by striking ``schedule 
                I or II'' and inserting ``schedule I, II, or A'';
                    (E) in section 403(a)(1) (21 U.S.C. 843(a)(1)), by 
                striking ``schedule I or II'' and inserting ``schedule 
                I, II, or A''; and
                    (F) in section 511(f) (21 U.S.C. 881(f)), by 
                striking ``schedule I or II'' each place it appears and 
                inserting ``schedule I, II, or A''.
            (2) Controlled substances import export act.--The 
        Controlled Substances Import and Export Act (21 U.S.C. 951 et 
        seq.) is amended--
                    (A) in section 1002(a) (21 U.S.C. 952(a))--
                            (i) in the matter preceding paragraph (1), 
                        by striking ``schedule I or II'' and inserting 
                        ``schedule I, II, or A''; and
                            (ii) in paragraph (2), by striking 
                        ``schedule I or II'' and inserting ``schedule 
                        I, II, or A'';
                    (B) in section 1003 (21 U.S.C. 953)--
                            (i) in subsection (c), in the matter 
                        preceding paragraph (1), by striking ``schedule 
                        I or II'' and inserting ``schedule I, II, or 
                        A''; and
                            (ii) in subsection (d), by striking 
                        ``schedule I or II'' and inserting ``schedule 
                        I, II, or A'';
                    (C) in section 1004(1) (21 U.S.C. 954(1)), by 
                striking ``schedule I'' and inserting ``schedule I or 
                A'';
                    (D) in section 1005 (21 U.S.C. 955), by striking 
                ``schedule I or II'' and inserting ``schedule I, II, or 
                A''; and
                    (E) in section 1009(a) (21 U.S.C. 959(a)), by 
                striking ``schedule I or II'' and inserting ``schedule 
                I, II, or A''.
    (g) Controlled Substance Analogues.--Section 102 of the Controlled 
Substances Act (21 U.S.C. 802) is amended--
            (1) in paragraph (6), by striking ``or V'' and inserting 
        ``V, or A'';
            (2) in paragraph (14)--
                    (A) by striking ``schedule I(c) and'' and inserting 
                ``schedule I(c), schedule A, and''; and
                    (B) by striking ``schedule I(c),'' and inserting 
                ``schedule I(c) and schedule A,''; and
            (3) in paragraph (32)(A), by striking ``(32)(A)'' and all 
        that follows through clause (iii) and inserting the following:
    ``(32)(A) Except as provided in subparagraph (C), the term 
`controlled substance analogue' means a substance whose chemical 
structure is substantially similar to the chemical structure of a 
controlled substance in schedule I or II--
            ``(i) which has a stimulant, depressant, or hallucinogenic 
        effect on the central nervous system that is substantially 
        similar to or greater than the stimulant, depressant, or 
        hallucinogenic effect on the central nervous system of a 
        controlled substance in schedule I or II; or
            ``(ii) with respect to a particular person, which such 
        person represents or intends to have a stimulant, depressant, 
        or hallucinogenic effect on the central nervous system that is 
        substantially similar to or greater than the stimulant, 
        depressant, or hallucinogenic effect on the central nervous 
        system of a controlled substance in schedule I or II.''.
    (h) Amendment to the Sentencing Guidelines.--Section 2D1.1 of the 
Federal Sentencing Guidelines is amended, in Application Note 6 
(Analogues and Controlled Substances Not Referenced in this Guideline) 
of the Commentary, by striking ``In determining the most closely 
related controlled substance, the court shall, to the extent 
practicable, consider the following:'' and inserting the following: 
``In determining the most closely related controlled substance and the 
applicable guideline or drug equivalence, the court shall--
                    ``(A) if Attorney General has provided guidance on 
                the appropriate sentencing equivalency or ratio to a 
                controlled substance that is referenced in the 
                guidelines through publication in the Federal Register 
                (whether such guidance is included in or separate from 
                any notice of proposed temporary or permanent 
                scheduling of such substance under section 201 of the 
                Controlled Substances Act (21 U.S.C. 811)), apply any 
                such sentencing equivalency or ratio; and
                    ``(B) in the absence of guidance with respect to a 
                substance or group of substances as described in 
                paragraph (A), use equivalencies for the following 
                structural classes of substances as if they were 
                included on the Drug Equivalency Tables:

----------------------------------------------------------------------------------------------------------------
                ``Drug Class                          Marihuana Equivalency of 1 gm  of subject substance
----------------------------------------------------------------------------------------------------------------
Synthetic Opioids...........................  1 gm = 10 kg
Synthetic Cannabinoids......................  1 gm = 167 gm
Synthetic Cathinones........................  1 gm = 380 gm
Tryptamine..................................  1 gm = 80 gm
Phenethylamines.............................  1 gm = 2.5 kg
Piperazines.................................  1 gm = 2 kg
Benzofurans.................................  1 gm = 500 gm
Arylcyclohexylamines                          ..................................................................
  (PCP-like substances).....................  1 gm = 1 kg
Methylphenidate analogs.....................  1 gm = 100 gm
Benzodiazepines.............................  1 `unit' (as defined in Note (F) to the Drug Quantity Table in
                                               2D1.1) = 0.0625 gm
----------------------------------------------------------------------------------------------------------------

        In the case of a substance for which paragraphs (A) and (B) 
        above are not applicable, the court shall determine an 
        equivalency or ratio by considering the following factors, to 
        the extent practicable:''.
    (i) Rules of Construction.--Nothing in this section, or the 
amendments made by this section, may be construed to limit--
            (1) the prosecution of offenses involving controlled 
        substance analogues under the Controlled Substances Act (21 
        U.S.C. 801 et seq.); or
            (2) the authority of the Attorney General to temporarily or 
        permanently schedule, reschedule, or decontrol controlled 
        substances under provisions of section 201 of the Controlled 
        Substances Act (21 U.S.C. 811) that are in effect on the day 
        before the date of enactment of this Act.
    (j) Study by Comptroller General.--Not later than 2 years after the 
date of enactment of this Act, the Comptroller General of the United 
States shall complete a study and submit a report to the Committees on 
the Judiciary of the House of Representatives and of the Senate 
regarding the costs associated with the amendments made by subsection 
(c), including--
            (1) the annual amounts expended by Federal agencies in 
        carrying out the amendments;
            (2) the costs associated with arrests, trials, convictions, 
        imprisonment, or imposition of other sanctions in accordance 
        with the amendments; and
            (3) the impact (including the fiscal impact) of the 
        amendments on existing correctional facilities and the 
        likelihood that those amendments will create a need for 
        additional capacity for housing prisoners.
                                 <all>
```