[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4938 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                H. R. 4938

        To address the opioid epidemic, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 6, 2018

 Ms. Kuster of New Hampshire introduced the following bill; which was 
 referred to the Committee on Energy and Commerce, and in addition to 
  the Committees on the Judiciary, Ways and Means, Education and the 
 Workforce, and the Budget, 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 address the opioid epidemic, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Respond to the Needs in the Opioid 
War Act'' or the ``Respond NOW Act''.

                 TITLE I--OPIOID EPIDEMIC RESPONSE FUND

SEC. 101. OPIOID EPIDEMIC RESPONSE FUND.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall use any funds 
appropriated pursuant to the authorization of appropriations under 
subsection (c) to carry out the programs and activities described in 
subsection (d) to address the opioid and substance use epidemic. Such 
funds shall be in addition to any funds which are otherwise available 
to carry out such programs and activities.
    (b) Opioid Epidemic Response Fund.--
            (1) Establishment of account.--There is established in the 
        Treasury an account, to be known as the Opioid Epidemic 
        Response Fund (referred to in this subsection as the 
        ``Funds''), for purposes of funding the programs and activities 
        described in subsection (d).
            (2) Transfer.--For each of fiscal years 2018 through 2022, 
        $5,000,000,000 shall be transferred to the Fund from the 
        general fund of the Treasury.
            (3) Amounts deposited.--Any amounts transferred under 
        paragraph (2) shall remain unavailable in the Fund until such 
        amounts are appropriated pursuant to subsection (c).
    (c) Appropriations.--
            (1) Authorization of appropriations.--For the period of 
        fiscal years 2018 through 2022, there is authorized to be 
        appropriated from the Fund to the Department of Health and 
        Human Services, for the purpose of carrying out the programs 
        and activities described in subsection (d), an amount not to 
        exceed the total amount transferred to the Fund under 
        subsection (b)(2), to remain available until expended.
            (2) Offsetting future appropriations.--For any of fiscal 
        years 2018 through 2022, for any discretionary appropriation to 
        the Department of Health and Human Services (or any agency 
        therein) pursuant to the authorization of appropriations under 
        paragraph (1) for the purpose of carrying out the programs and 
        activities described in subsection (d), the total amount of 
        such appropriations for the applicable fiscal year (not to 
        exceed the total amount remaining in the Account) shall be 
        subtracted from the estimate of discretionary budget authority 
        and the resulting outlays for any estimate under the 
        Congressional Budget and Impoundment Control Act of 1974 or the 
        Balanced Budget and Emergency Deficit Control Act of 1985, and 
        the amount transferred to the Fund shall be reduced by the same 
        amount.
    (d) Programs and Activities.--Of the total amount authorized to be 
appropriated from the Fund to the Department of Health and Human 
Services by subsection (c)(1), such amount shall be allocated as 
follows:
            (1) SAMHSA.--For the Substance Abuse and Mental Health 
        Services Administration to carry out programs and activities 
        pursuant to section 102, $3,650,000,000 for each of fiscal 
        years 2018 through 2022.
            (2) CDC.--For the Centers for Disease Control and 
        Prevention to carry out programs and activities pursuant to 
        section 103, $500,000,000 for each of fiscal years 2018 through 
        2022.
            (3) FDA.--For the Food and Drug Administration to carry out 
        programs and activities pursuant to section 104, $65,000,000 
        for each of fiscal years 2018 through 2022.
            (4) NIH.--For the National Institutes of Health to carry 
        out programs and activities pursuant to section 105, 
        $500,000,000 for each of fiscal years 2018 through 2022.
            (5) HRSA.--For the Health Resources and Services 
        Administration to carry out programs and activities pursuant to 
        section 106, $235,000,000 for each of fiscal years 2018 through 
        2022.
            (6) ACF.--For the Administration for Children and Families 
        to carry out programs and activities pursuant to section 107, 
        $50,000,000 for each of fiscal years 2018 through 2022.
    (e) Accountability and Oversight.--
            (1) Work plan.--
                    (A) In general.--Not later than 180 days after the 
                date of enactment of this Act, the Secretary of Health 
                and Human Services 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 work 
                plan including the proposed allocation of funds 
                appropriated pursuant to the authorization of 
                appropriations under subsection (c) for each of fiscal 
                years 2018 through 2022 and the contents described in 
                subparagraph (B).
                    (B) Contents.--The work plan submitted under 
                subparagraph (A) shall include--
                            (i) the amount of money to be obligated or 
                        expended out of the Fund in each fiscal year 
                        for each program and activity described in 
                        subsection (d); and
                            (ii) a description and justification of 
                        each such program and activity.
            (2) Reports.--
                    (A) Annual reports.--Not later than October 1 of 
                each of fiscal years 2019 through 2023, the Secretary 
                of Health and Human Services 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 including--
                            (i) the amount of money obligated or 
                        expended out of the Fund in the prior fiscal 
                        year for each program and activity described in 
                        subsection (d);
                            (ii) a description of all programs and 
                        activities using funds provided pursuant to the 
                        authorization of appropriations under 
                        subsection (c); and
                            (iii) how the programs and activities are 
                        responding to the opioid epidemic.
                    (B) 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 
                Commissioner shall provide an update in the form of 
                testimony and any additional reports to the respective 
                congressional committee regarding the allocation of 
                funding under this section or the description of the 
                programs and activities undertaken with such funding.
    (f) Limitations.--Notwithstanding any transfer authority authorized 
by this Act or any appropriations Act, any funds made available 
pursuant to the authorization of appropriations under subsection (c) 
may not be used for any purpose other than the programs and activities 
described in subsection (d) to address the opioid and substance use 
epidemic.
    (g) Sunset.--This section shall expire at the end of fiscal year 
2027.

SEC. 102. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.

    The entirety of the funds made available pursuant to section 
101(d)(1) shall be for carrying out subsections (c) and (d) of section 
1003 of the 21st Century Cures Act, as amended by section 203.

SEC. 103. CENTERS FOR DISEASE CONTROL AND PREVENTION.

    (a) Addressing Opioid Use Disorder.--The entirety of the funds made 
available pursuant to section 101(d)(2) shall be for the Director of 
the Centers for Disease Control and Prevention, pursuant to applicable 
authorities in the Public Health Service Act (42 U.S.C. 201 et seq.), 
to continue and expand programs of the Centers for Disease Control and 
Prevention to address opioid use disorder, including by--
            (1) improving the timeliness and quality of data on the 
        opioid epidemic, including improvement of--
                    (A) data on fatal and nonfatal overdoses;
                    (B) syndromic surveillance;
                    (C) data on long-term sequelae (including neonatal 
                abstinence syndrome); and
                    (D) cause of death reporting related to substance 
                abuse or opioid overdose;
            (2) expanding and strengthening evidence-based prevention 
        and education strategies;
            (3) supporting responsible prescribing practices, including 
        through development and dissemination of prescriber guidelines;
            (4) improving access to and use of effective prevention, 
        treatment, and recovery support, including through grants and 
        the provision of technical assistance to States and localities;
            (5) strengthening partnerships with first responders, 
        including to protect their safety;
            (6) considering the needs of vulnerable populations;
            (7) addressing infectious diseases linked to the opioid 
        crisis; and
            (8) strengthening prescription drug monitoring programs.
    (b) Limitation.--Of the funds made available pursuant to section 
101(d)(2) for carrying out this section, not more than 20 percent may 
be used for intramural purposes.

SEC. 104. FOOD AND DRUG ADMINISTRATION.

    The entirety of the funds made available pursuant to section 
101(d)(3) shall be for the Commissioner of Food and Drugs, pursuant to 
applicable authorities in the Public Health Service Act (42 U.S.C. 201 
et seq.) or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) and other applicable law, to support widespread innovation in 
non-opioid and non-addictive medical products for pain treatment, 
access to opioid addiction treatments, appropriate use of approved 
opioids, and efforts to reduce illicit importation of opioids. Such 
support may include the following:
            (1) Facilitating the development of non-opioid and non-
        addictive pain treatments.
            (2) Advancing guidance documents for sponsors of non-opioid 
        pain products.
            (3) Developing evidence to inform the potential for 
        nonprescription overdose therapies.
            (4) Examining expanded labeling indications for medication-
        assisted treatment.
            (5) Conducting public education and outreach, including 
        public workshops or public meetings, regarding the benefits of 
        medication-assisted treatment, and approved non-opioid drug and 
        device treatment options.
            (6) Exploring the expansion and possible mandatory nature 
        of prescriber education regarding pain management and 
        appropriate opioid prescribing through authorities under 
        section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355-1).
            (7) Examining options to limit the duration of opioid 
        prescriptions for acute pain, including through packaging 
        options.
            (8) Increasing staff and infrastructure capacity to inspect 
        and analyze packages at international mail facilities and 
        pursue criminal investigations.

SEC. 105. NATIONAL INSTITUTES OF HEALTH.

    The entirety of the funds made available pursuant to section 
101(d)(4) shall be for the Director of the National Institutes of 
Health, pursuant to applicable authorities in the Public Health Service 
Act (42 U.S.C. 201 et seq.), to carry out activities related to--
            (1) accelerating research for addressing the opioid 
        epidemic, including developing non-opioid medications and 
        interventions, including non-addictive medications, to manage 
        pain, as well as to treat and to prevent substance use 
        disorders;
            (2) conducting and supporting research on which treatments 
        (in terms of pain management as well as treating and preventing 
        substance use disorders) are optimal for which patients; and
            (3) conducting and supporting research on creating longer-
        lasting or faster-acting antidotes for opioid overdose, 
        particularly in response to the prevalence of fentanyl and 
        carfentanyl overdoses.

SEC. 106. HEALTH RESOURCES AND SERVICES ADMINISTRATION.

    The entirety of the funds made available pursuant to section 
101(d)(5) shall be for the Administrator of the Health Resources and 
Services Administration, pursuant to applicable authorities in titles 
III, VII, and VIII of the Public Health Service Act (42 U.S.C. 241 et 
seq.), to carry out activities that increase the availability and 
capacity of the behavioral health workforce. Such activities may 
include providing loan repayment assistance for substance abuse 
treatment providers.

SEC. 107. ADMINISTRATION FOR CHILDREN AND FAMILIES.

    Of the funds made available pursuant to section 101(d)(6) for each 
of fiscal years 2018 through 2022--
            (1) $25,000,000 for each such fiscal year shall be for the 
        Secretary of Health and Human Services to carry out title I of 
        the Child Abuse Prevention and Treatment Act (42 U.S.C. 5101 et 
        seq.); and
            (2) $25,000,000 for each such fiscal year shall be for the 
        Secretary of Health and Human Services to carry out title II of 
        such Act (42 U.S.C. 5116 et seq.).

TITLE II--ADDITIONAL INVESTMENTS IN EXISTING PROGRAMS TO RESPOND TO THE 
                            OPIOID EPIDEMIC

SEC. 201. INCREASE IN FUNDING FOR REGIONAL PARTNERSHIP GRANTS.

    Section 436 of the Social Security Act (42 U.S.C. 629f) is 
amended--
            (1) in subsection (a), by striking ``$345,000,000 for each 
        of fiscal years 2012 through 2016'' and inserting 
        ``$385,000,000 for each of fiscal years 2018 through 2023''; 
        and
            (2) in subsection (b)--
                    (A) in paragraph (4)(A), by striking ``2012 through 
                2016'' and inserting ``2018 through 2023''; and
                    (B) in paragraph (5), by striking ``$20,000,000 for 
                each of fiscal years 2012 through 2016'' and inserting 
                ``$60,000,000 for each of fiscal years 2018 through 
                2023''.

SEC. 202. ACCOUNT FOR THE STATE AND TRIBAL RESPONSE TO THE OPIOID ABUSE 
              CRISIS.

    Section 1003 of the 21st Century Cures Act (42 U.S.C. 290ee-3 note) 
is amended--
            (1) in subsection (b)(2), by amending subparagraph (A) to 
        read as follows:
                    ``(A) In general.--The following amounts shall be 
                transferred to the Account from the general fund of the 
                Treasury:
                            ``(i) For fiscal year 2017, $500,000,000.
                            ``(ii) For each of fiscal years 2018 
                        through 2022, $3,750,000,000.'';
            (2) in subsection (b)(2), by adding at the end the 
        following:
                    ``(C) Set aside.--Of the amount transferred 
                pursuant to subparagraph (A) for each of fiscal years 
                2018 through 2022, 3 percent shall be set aside for 
                Indian tribes, tribal organizations, and Urban Indian 
                organizations (as such terms are defined in section 4 
                of the Indian Health Care Improvement Act).'';
            (3) in subsection (c)(1), by striking the second sentence 
        and inserting the following: ``In awarding such grants and 
        allocating funds pursuant to such grants among the States, the 
        Secretary shall account for the prevalence of opioid use 
        disorders and deaths from overdose, including taking into 
        account which States are hardest hit by the opioid epidemic.'';
            (4) by redesignating subsection (f) as subsection (g); and
            (5) by inserting after subsection (e) the following:
    ``(f) Definition.--In this section, the term `State' includes an 
Indian tribe, tribal organization, and Urban Indian organization (as 
such terms are defined in section 4 of the Indian Health Care 
Improvement Act).''.

           TITLE III--EXPANDING ACCESS TO TREATMENT SERVICES

SEC. 301. ALLOWING FOR MORE FLEXIBILITY WITH RESPECT TO MEDICATION-
              ASSISTED TREATMENT FOR OPIOID USE DISORDERS.

    (a) Conforming Applicable Number.--Subclause (II) of section 
303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C. 
823(g)(2)(B)(iii)) is amended to read as follows:
                                    ``(II) The applicable number is--
                                            ``(aa) 100 if, not sooner 
                                        than 1 year after the date on 
                                        which the practitioner 
                                        submitted the initial 
                                        notification, the practitioner 
                                        submits a second notification 
                                        to the Secretary of the need 
                                        and intent of the practitioner 
                                        to treat up to 100 patients;
                                            ``(bb) 100 if the 
                                        practitioner holds additional 
                                        credentialing, as defined in 
                                        section 8.2 of title 42, Code 
                                        of Federal Regulations (or 
                                        successor regulations);
                                            ``(cc) 100 if the 
                                        practitioner provides 
                                        medication-assisted treatment 
                                        (MAT) using covered medications 
                                        (as defined in section 8.2 of 
                                        title 42, Code of Federal 
                                        Regulations (or successor 
                                        regulations)) in a qualified 
                                        practice setting (as described 
                                        in section 8.615 of title 42, 
                                        Code of Federal Regulations (or 
                                        successor regulations)); or
                                            ``(dd) 275 if the 
                                        practitioner meets the 
                                        requirements specified in 
                                        section 8.610 of title 42, Code 
                                        of Federal Regulations (or 
                                        successor regulations).''.
    (b) Eliminating Any Time Limitation for Nurse Practitioners, 
Clinical Nurse Specialists, Certified Registered Nurse Anesthetists, 
Certified Nurse Midwives, and Physician Assistants To Become Qualifying 
Practitioners.--Section 303(g)(2)(G)(iii)(II) of the Controlled 
Substances Act (21 U.S.C. 823(g)(2)(G)(iii)(II)) is amended by striking 
``during the period beginning on the date of enactment of the 
Comprehensive Addiction and Recovery Act of 2016 and ending on October 
1, 2021'' and inserting ``beginning on the date of enactment of the 
Comprehensive Addiction and Recovery Act of 2016''.
    (c) Definition of Qualifying Other Practitioner.--Clause (iv) of 
section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 
823(g)(2)(G)) is amended by striking ``nurse practitioner or physician 
assistant'' each place it appears and inserting ``nurse practitioner, 
clinical nurse specialist, certified registered nurse anesthetist, 
certified nurse midwife, or physician assistant''.

SEC. 302. COVERAGE OF METHADONE UNDER MEDICARE PART B.

    (a) Coverage.--Section 1861(s)(2) of the Social Security Act (42 
U.S.C. 1395x(s)(2)) is amended--
            (1) by striking ``and'' at the end of subparagraph (FF);
            (2) by adding ``and'' at the end of subparagraph (GG); and
            (3) by inserting after subparagraph (GG) the following new 
        subparagraph:
                    ``(HH) methadone, if furnished or dispensed 
                (including by prescription) in an oral form on or after 
                January 1, 2018, to an individual for the purpose of 
                maintenance or detoxification treatment by a physician 
                or other practitioner who has in effect a registration 
                or waiver under section 303(g) of such Act (21 U.S.C. 
                823(g)) to dispense methadone for such purpose;''.
    (b) Payment.--
            (1) In connection with physician and supplier service.--
        Section 1842(o)(1) of the Social Security Act (42 U.S.C. 
        1395u(o)(1)) is amended by adding at the end the following new 
        subparagraph:
                    ``(H) In the case of methadone (as described in 
                section 1861(s)(2)(HH)), the amount provided under 
                section 1847A for such drug.''.
            (2) Covered opd service.--Section 1833(t)(1)(B)(iii) of the 
        Social Security Act (42 U.S.C. 1395l(t)(1)(B)(iii)) is amended 
        by inserting ``and methadone described in paragraph (2)(HH) of 
        such section'' after ``section 1861(s)''.
    (c) Budget Neutrality.--The Secretary of Health and Human Services 
shall implement the amendments made by this section in a manner such 
that--
            (1) estimated expenditures under the physician fee schedule 
        under section 1848 of the Social Security Act (42 U.S.C. 1395w-
        4) with application of such amendments are equal to estimated 
        expenditures under such schedule without application of such 
        amendments; and
            (2) estimated expenditures under the prospective payment 
        system under section 1833(t) of the Social Security Act (42 
        U.S.C. 1395l(t)) with application of such amendments made by 
        this section are equal to estimated expenditures under such 
        system without application of such amendments.
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