,i #aafth ,,congress #ast ,session ,h4 ,r4 #bibb ,,in ,,the ,,house ,,of ,,representatives ,may #bb1 #bjai,ms4 ,kuster of ,new ,hampshire 7for herself1 ,mr4 ,fitzpatrick1 ,ms4 ,scanlon1 ,ms4 ,pingree1 ,ms4 ,stevens1 ,ms4 ,jackson ,lee1 ,ms4 ,frankel1 ,mr4 ,trone1 ,mr4 ,tonko1 ,mr4 ,raskin1 ,ms4 ,brownley of ,california1 ,mr4 ,doggett1 ,mr4 ,pappas1 ,ms4 ,clark of ,massachusetts1 ,mrs4 ,trahan1 ,mr4 ,welch1 ,mr4 ,castro of ,texas1 ,mrs4 ,dingell1 ,ms4 ,shalala1 ,ms4 ,moore1 ,mr4 ,mc,nerney1 ,mr4 ,moulton1 ,ms4 ,blunt ,rochester1 ,mr4 ,mc,govern1 ,mr4 ,larson of ,connecticut1 ,mr4 ,crow1 ,ms4 ,matsui1 ,ms4 ,kelly of ,illinois1 ,ms4 ,barragn1 ,ms4 ,schakowsky1 ,mr4 ,veasey1 and ,ms4 ,bass7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on the ,judiciary1 ,ways and ,means1 the ,budget1 and ,education and ,labor1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to address the opioid epidemic1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,respond to the ,needs in the ,opioid ,war ,act or the ,respond ,,now ,act4 #b4 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,title ,i--,opioid ,epidemic ,response ,fund ,sec4 #aja4 ,opioid ,epidemic ,response ,fund4 ,sec4 #ajb4 ,substance ,abuse and ,mental ,health ,services ,administration4 ,sec4 #ajc4 ,centers for ,disease ,control and ,prevention4 ,sec4 #ajd4 ,food and ,drug ,administration4 ,sec4 #aje4 ,national ,institutes of ,health4 ,sec4 #ajf4 ,health ,resources and ,services ,administration4 ,sec4 #ajg4 ,administration for ,children and ,families4 ,title ,,ii--,additional ,investments in ,existing ,programs ,to ,respond to the ,opioid ,epidemic ,sec4 #bja4 ,increase in funding for regional partnership grants4 ,sec4 #bjb4 ,account for the ,state and ,tribal ,response to the ,opioid ,abuse ,crisis4 ,title ,,iii--,expanding ,access to ,treatment ,services ,sec4 #cja4 ,eliminating time limitation for nurse practitioners1 clinical nurse specialists1 certified registered nurse anesthetists1 certified nurse midwives1 and physician assistants ,to be qualifying practitioners4 ,sec4 #cjb4 ,coverage of methadone under ,medicare part ,b4 ,i ,opioid ,epidemic ,response ,fund #aja4 ,opioid ,epidemic ,response ,fund 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall use any funds appropriated pursuant to the authorization of appropriations under subsection 7c7 to carry out the programs and activities described in subsection 7d7 to address the opioid and substance use epidemic4 ,such funds shall be in addition to any funds which are otherwise available to carry out such programs and activities4 7b7 ,opioid ,epidemic ,response ,fund 7#a7 ,establishment of account ,there is established in the ,treasury an account1 to be known as the ,opioid ,epidemic ,response ,fund 7referred to in this section as the ,fund71 for purposes of funding the programs and activities described in subsection 7d74 7#b7 ,transfer ,for each of fiscal years #bjbj through #bjbd1 #e1jjj1jjj1jjj shall be transferred to the ,fund from the general fund of the ,treasury4 7#c7 ,amounts deposited ,any amounts transferred under paragraph 7#b7 shall remain unavailable in the ,fund until such amounts are appropriated pursuant to subsection 7c74 7c7 ,appropriations 7#a7 ,authorization of appropriations ,for the period of fiscal years #bjbj through #bjbd1 there is authorized to be appropriated from the ,fund to the ,department of ,health and ,human ,services1 for the purpose of carrying out the programs and activities described in subsection 7d71 an amount not to exceed the total amount transferred to the ,fund under subsection 7b77#b71 to remain available until expended4 7#b7 ,offsetting future appropriations ,for any of fiscal years #bjbj through #bjbd1 for any discretionary appropriation to the ,department of ,health and ,human ,services 7or any agency therein7 pursuant to the authorization of appropriations under paragraph 7#a7 for the purpose of carrying out the programs and activities described in subsection 7d71 the total amount of such appropriations for the applicable fiscal year 7not to exceed the total amount remaining in the ,account7 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 #aigd or the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe1 and the amount transferred to the ,fund shall be reduced by the same amount4 7d7 ,programs and activities ,of the total amount authorized to be appropriated from the ,fund to the ,department of ,health and ,human ,services by subsection 7c77#a71 such amount shall be allocated as follows3 7#a7 ,,samhsa ,for the ,substance ,abuse and ,mental ,health ,services ,administration to carry out programs and activities pursuant to section #ajb1 #c1fej1jjj1jjj for each of fiscal years #bjbj through #bjbd4 7#b7 ,,cdc ,for the ,centers for ,disease ,control and ,prevention to carry out programs and activities pursuant to section #ajc1 #ejj1jjj1jjj for each of fiscal years #bjbj through #bjbd4 7#c7 ,,fda ,for the ,food and ,drug ,administration to carry out programs and activities pursuant to section #ajd1 #fe1jjj1jjj for each of fiscal years #bjbj through #bjbd4 7#d7 ,,nih ,for the ,national ,institutes of ,health to carry out programs and activities pursuant to section #aje1 #ejj1jjj1jjj for each of fiscal years #bjbj through #bjbd4 7#e7 ,,hrsa ,for the ,health ,resources and ,services ,administration to carry out programs and activities pursuant to section #ajf1 #bce1jjj1jjj for each of fiscal years #bjbj through #bjbd4 7#f7 ,,acf ,for the ,administration for ,children and ,families to carry out programs and activities pursuant to section #ajg1 #ej1jjj1jjj for each of fiscal years #bjbj through #bjbd4 7e7 ,accountability and oversight 7#a7 ,work plan 7,a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 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 ,representatives1 a work plan including the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection 7c7 for each of fiscal years #bjbj through #bjbd and the contents described in subparagraph 7,b74 7,b7 ,contents ,the work plan submitted under subparagraph 7,a7 shall include-- 7i7 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 7d72 and 7ii7 a description and justification of each such program and activity4 7#b7 ,reports 7,a7 ,annual reports ,not later than ,october #a of each of fiscal years #bjbj through #bjbd1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 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 ,representatives1 a report including-- 7i7 the amount of money obligated or expended out of the ,fund in the prior fiscal year for each program and activity described in subsection 7d72 7ii7 a description of all programs and activities using funds provided pursuant to the authorization of appropriations under subsection 7c72 and 7iii7 how the programs and activities are responding to the opioid epidemic4 7,b7 ,additional reports ,at the request of the ,committee on ,health1 ,education1 ,labor1 and ,pensions or the ,committee on ,appropriations of the ,senate1 or the ,committee on ,energy and ,commerce or the ,committee on ,appropriations of the ,house of ,representatives1 the ,secretary of ,health and ,human ,services 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 funding4 7f7 ,limitations ,notwithstanding any transfer authority authorized by this ,act or any appropriations ,act1 any funds made available pursuant to the authorization of appropriations under subsection 7c7 may not be used for any purpose other than the programs and activities described in subsection 7d7 to address the opioid and substance use epidemic4 7g7 ,sunset ,this section shall expire at the end of fiscal year #bjbi4 #ajb4 ,substance ,abuse and ,mental ,health ,services ,administration ,the entirety of the funds made available pursuant to section #aja7;d77#a7 shall be for carrying out subsections 7b7 and 7c7 of section #ajjc of the #bast ,century ,cures ,act 7#db ,u4,s4,c4 #bij;ee-#c note74 #ajc4 ,centers for ,disease ,control and ,prevention 7a7 ,addressing opioid use disorder ,the entirety of the funds made available pursuant to section #aja7;d77#b7 shall be for the ,director of the ,centers for ,disease ,control and ,prevention1 pursuant to applicable authorities in the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq471 to continue and expand programs of the ,centers for ,disease ,control and ,prevention to address opioid use disorder1 including by-- 7#a7 improving the timeliness and quality of data on the opioid epidemic1 including improvement of-- 7,a7 data on fatal and nonfatal overdoses2 7,b7 syndromic surveillance2 7,c7 data on long-term sequelae 7including neonatal abstinence syndrome72 and 7,d7 cause of death reporting related to substance abuse or opioid overdose2 7#b7 expanding and strengthening evidence-based prevention and education strategies2 7#c7 supporting responsible prescribing practices1 including through development and dissemination of prescriber guidelines2 7#d7 improving access to and use of effective prevention1 treatment1 and recovery support1 including through grants and the provision of technical assistance to ,states and localities2 7#e7 strengthening partnerships with first responders1 including to protect their safety2 7#f7 considering the needs of vulnerable populations2 7#g7 addressing infectious diseases linked to the opioid crisis2 7#h7 strengthening prescription drug monitoring programs2 and 7#i7 providing financial and technical assistance to ,state and local health department efforts to treat and prevent substance use disorder4 7b7 ,limitation ,of the funds made available pursuant to section #aja7;d77#b7 for carrying out this section1 not more than #bj percent may be used for intramural purposes4 #ajd4 ,food and ,drug ,administration ,the entirety of the funds made available pursuant to section #aja7;d77#c7 shall be for the ,commissioner of ,food and ,drugs1 pursuant to applicable authorities in the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 or the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 and other applicable law1 to support widespread innovation in non-opioid and non-addictive medical products for pain treatment1 access to opioid addiction treatments1 appropriate use of approved opioids1 and efforts to reduce illicit importation of opioids4 ,such support may include the following3 7#a7 ,facilitating the development of non-opioid and non-addictive pain treatments4 7#b7 ,advancing guidance documents for sponsors of non-opioid pain products4 7#c7 ,developing evidence to inform the potential for nonprescription overdose therapies4 7#d7 ,examining expanded labeling indications for medication-assisted treatment4 7#e7 ,conducting public education and outreach1 including public workshops or public meetings1 regarding the benefits of medication-assisted treatment1 and approved non-opioid drug and device treatment options4 7#f7 ,exploring the expansion and possible mandatory nature of prescriber education regarding pain management and appropriate opioid prescribing through authorities under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a74 7#g7 ,examining options to limit the duration of opioid prescriptions for acute pain1 including through packaging options4 7#h7 ,increasing staff and infrastructure capacity to inspect and analyze packages at international mail facilities and pursue criminal investigations4 #aje4 ,national ,institutes of ,health ,the entirety of the funds made available pursuant to section #aja7;d77#d7 shall be for the ,director of the ,national ,institutes of ,health1 pursuant to applicable authorities in the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq471 to carry out activities related to-- 7#a7 accelerating research for addressing the opioid epidemic1 including developing non-opioid medications and interventions1 including non-addictive medications1 to manage pain1 as well as to treat and to prevent substance use disorders2 7#b7 conducting and supporting research on which treatments 7in terms of pain management as well as treating and preventing substance use disorders7 are optimal for which patients2 and 7#c7 conducting and supporting research on creating longer-lasting or faster-acting antidotes for opioid overdose1 particularly in response to the prevalence of fentanyl and carfentanyl overdoses4 #ajf4 ,health ,resources and ,services ,administration ,the entirety of the funds made available pursuant to section #aja7;d77#e7 shall be for the ,administrator of the ,health ,resources and ,services ,administration1 pursuant to applicable authorities in titles ,,iii1 ,,vii1 and ,,viii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq471 to carry out activities that increase the availability and capacity of the behavioral health workforce4 ,such activities may include providing loan repayment assistance for substance abuse treatment providers4 #ajg4 ,administration for ,children and ,families ,of the funds made available pursuant to section #aja7;d77#f7 for each of fiscal years #bjbj through #bjbd-- 7#a7 #be1jjj1jjj 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 7#db ,u4,s4,c4 #eaja et seq472 and 7#b7 #be1jjj1jjj for each such fiscal year shall be for the ,secretary of ,health and ,human ,services to carry out title ,,ii of such ,act 7#db ,u4,s4,c4 #eaaf et seq474 ,,ii ,additional ,investments in ,existing ,programs ,to ,respond to the ,opioid ,epidemic #bja4 ,increase in funding for regional partnership grants ,section #dcf of the ,social ,security ,act 7#db ,u4,s4,c4 #fbi;f7 is amended-- 7#a7 in subsection 7a71 by striking #cde1jjj1jjj for each of fiscal years #bjag through #bjba and inserting #che1jjj1jjj for each of fiscal years #bjah through #bjbd2 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#d77;,a71 by striking #bjag through #bjba and inserting #bjah through #bjbd2 and 7,b7 in paragraph 7#e71 by striking #bj1jjj1jjj for each of fiscal years #bjag through #bjba and inserting #fj1jjj1jjj for each of fiscal years #bjah through #bjbd4 #bjb4 ,account for the ,state and ,tribal response to the opioid abuse crisis ,section #ajjc7;h7 of the #bast ,century ,cures ,act 7#db ,u4,s4,c4 #bij;ee-#c note7 is amended by striking #ejj1jjj1jjj for each of fiscal years #bjai through #bjba and inserting #ejj1jjj1jjj for fiscal years #bjai and #c1gej1jjj1jjj for each of fiscal years #bjbj through #bjbc4 ,,iii ,expanding ,access to ,treatment ,services #cja4 ,eliminating time limitation for nurse practitioners1 clinical nurse specialists1 certified registered nurse anesthetists1 certified nurse midwives1 and physician assistants ,to be qualifying practitioners ,section #cjc7;g77#b77;,g77iii77,,iii7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77iii77,,iii77 is amended by striking for the period beginning on ,october #a1 #bjah1 and ending on ,october #a1 #bjbc14 #cjb4 ,coverage of methadone under ,medicare part ,b 7a7 ,coverage ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7#a7 by striking and at the end of subparagraph 7,,gg72 7#b7 by adding and at the end of subparagraph 7,,hh72 and 7#c7 by inserting after subparagraph 7,,hh7 the following new subparagraph3 7,,ii7 methadone1 if furnished or dispensed 7including by prescription7 in an oral form on or after ,january #a1 #bjai1 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 #cjc7;g7 of such ,act 7#ba ,u4,s4,c4 #hbc7;g77 to dispense methadone for such purpose2 4 7b7 ,payment 7#a7 ,in connection with physician and supplier service ,section #ahdb7o77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7o77#a77 is amended by adding at the end the following new subparagraph3 7,h7 ,in the case of methadone 7as described in section #ahfa7s77#b77;,,ii771 the amount provided under section #ahdg;,a for such drug4 4 7#b7 ,covered ,,opd service ,section #ahcc7t77#a77;,b77iii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#a77;,b77iii77 is amended by inserting and methadone described in paragraph 7#b77;,,ii7 of such section after section #ahfa7s74 7c7 ,budget neutrality ,the ,secretary of ,health and ,human ,services shall implement the amendments made by this section in a manner such that-- 7#a7 estimated expenditures under the physician fee schedule under section #ahdh of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7 with application of such amendments are equal to estimated expenditures under such schedule without application of such amendments2 and 7#b7 estimated expenditures under the prospective payment system under section #ahcc7t7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77 with application of such amendments made by this section are equal to estimated expenditures under such system without application of such amendments4