I 115th CONGRESS 2d Session H. R. 4938 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.

1. Short title This Act may be cited as the Respond to the Needs in the Opioid War Act or the Respond NOW Act . I Opioid Epidemic Response Fund 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. 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. 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. 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. 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. 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. 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.). II Additional Investments in Existing Programs to Respond to the Opioid Epidemic 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 . 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). . III Expanding Access to Treatment Services 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 . 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.