,i #aaeth ,,congress #b;d ,session ,h4 ,r4 #eede ,,in ,,the ,,house ,,of ,,representatives ,april #ah1 #bjah,mr4 ,cummings introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on the ,judiciary1 and ,natural ,resources1 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 provide emergency assistance to ,states1 territories1 ,tribal nations1 and local areas affected by the opioid epidemic and to make financial assistance available to ,states1 territories1 ,tribal nations1 local areas1 and public or private nonprofit entities to provide for the development1 organization1 coordination1 and operation of more effective and cost efficient systems for the delivery of essential services to individuals with substance use disorder and their families4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,comprehensive ,addiction ,resources ,emergency ,act of #bjah4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,purpose4 ,sec4 #c4 ,amendment to the ,public ,health ,service ,act4 ,,title ,,xxxiv--,substance use and opioid health resources ,subtitle ,a--,substance use and opioid emergency relief grant program ,sec4 #cdja4 ,establishment of program of grants4 ,sec4 #cdjb4 ,planning council4 ,sec4 #cdjc4 ,amount of grant and use of amounts4 ,sec4 #cdjd4 ,application4 ,sec4 #cdje4 ,technical assistance4 ,sec4 #cdjf4 ,authorization of appropriations4 ,subtitle ,b--,state and ,tribal substance use disorder prevention and intervention grant program ,sec4 #cdaa4 ,establishment of program of grants4 ,sec4 #cdab4 ,amount of grant and use of amounts4 ,sec4 #cdac4 ,application and limitation4 ,sec4 #cdad4 ,technical assistance4 ,sec4 #cdae4 ,authorization of appropriations4 ,subtitle ,c--,other grant program ,sec4 #cdba4 ,establishment of grant program4 ,sec4 #cdbb4 ,use of amounts4 ,sec4 #cdbc4 ,technical assistance4 ,sec4 #cdbd4 ,planning and development grants4 ,sec4 #cdbe4 ,authorization of appropriations4 ,subtitle ,d--,miscellaneous provisions ,sec4 #cdca4 ,special projects of national significance4 ,sec4 #cdcb4 ,education and training centers4 ,sec4 #cdcc4 ,other provisions4 ,sec4 #cdcd4 ,standards for substance use disorder treatment and recovery facilities4 ,sec4 #cdce4 ,naloxone distribution program4 ,sec4 #cdcf4 ,additional funding for the ,national ,institutes of ,health4 ,sec4 #cdcg4 ,additional funding for improved data collection and prevention of infectious disease transmission4 ,sec4 #cdch4 ,definitions4 ,sec4 #d4 ,amendments to the ,controlled ,substances ,act4 #b4 ,purpose ,it is the purpose of this ,act to provide emergency assistance to ,states1 territories1 ,tribal nations1 and local areas that are disproportionately affected by the opioid epidemic and to make financial assistance available to ,states1 territories1 ,tribal nations1 local areas1 and other public or private nonprofit entities to provide for the development1 organization1 coordination1 and operation of more effective and cost efficient systems for the delivery of essential services to individuals and families with substance use disorder4 #c4 ,amendment to the ,public ,health ,service ,act ,the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 is amended by adding at the end the following3 ,,xxxiv ,substance use and opioid health resources ,a ,substance use and opioid emergency relief grant program #cdja4 ,establishment of program of grants 7a7 ,in general ,the ,secretary1 in coordination with the ,director of the ,office of ,national ,drug ,control ,policy1 shall award grants to eligible localities for the purpose of addressing substance use within such localities4 7b7 ,eligibility 7#a7 ,in general ,to be eligible to receive a grant under subsection 7a7 a locality shall-- 7,a7 be-- 7i7 a county that can demonstrate that the rate of drug overdose deaths per #ajj1jjj individuals residing in the county during the most recent #c-year period for which such data are available was not less than the rate of such deaths for the county that ranked at the #fgth percentile of all counties1 as determined by the ,secretary2 7ii7 a county that can demonstrate that the number of drug overdose deaths during the most recent #c-year period for which such data are available was not less than the number of such deaths for the county that ranked at the #ijth percentile of all counties1 as determined by the ,secretary2 or 7iii7 a city that is located within a county described in clause 7i7 or 7ii71 that meets the requirements of paragraph 7#c72 and 7,b7 submit to the ,secretary an application in accordance with section #cdjd4 7#b7 ,multiple contiguous counties ,in the case of an eligible county that is contiguous to one or more other eligible counties within the same ,state1 the group of counties shall-- 7,a7 be considered as a single eligible county for purposes of a grant under this section2 7,b7 submit a single application under section #cdjd2 7,c7 form a joint planning council 7for the purposes of section #cdjb72 and 7,d7 establish1 through intergovernmental agreements1 an administrative mechanism to allocate funds and substance use disorder treatment services under the grant based on-- 7i7 the number and rate of drug overdose deaths and nonfatal drug overdoses in each of the counties that compose the eligible county2 7ii7 the severity of need for services in each such county2 and 7iii7 the health and support personnel needs of each such county4 7#c7 ,cities and counties within multiple contiguous counties 7,a7 ,in general ,a city that is within an eligible county described in paragraph 7#a71 or a group of counties that is within a group of counties determined to be an eligible county under paragraph 7#b71 shall be eligible to receive a grant under section #cdja if such city or county or group of counties meets the requirements of subparagraph 7,b74 7,b7 ,requirements ,a city or county meets the requirements of this subparagraph if such city or county-- 7i7 except as provided in subparagraph 7,c71 has a population of not less than #ej1jjj residents2 7ii7 meets the requirements of paragraph 7#a77;,a72 7iii7 submits an application under section #cdjd2 7iv7 establishes a planning council 7for purposes of section #cdjb72 and 7v7 establishes an administrative mechanism to allocate funds and services under the grant based on-- 7,i7 the number and rate of drug overdose deaths and nonfatal drug overdoses in the city or county2 7,,ii7 the severity of need for substance use disorder treatment services in the city or county2 and 7,,iii7 the health and support personnel needs of the city or county4 7,c7 ,population exception ,a city or county or group of counties that does not meet the requirements of subparagraph 7,b77i7 may apply to the ,secretary for a waiver of such requirement4 ,such application shall demonstrate-- 7i7 that the needs of the population to be served are distinct or that addressing substance use in the service area would be best served by the formation of an independent council2 and 7ii7 that the city or county or group of counties has the capacity to administer the funding received under this subtitle4 7,d7 ,minimum funding ,a city or county that meets the requirement of this paragraph and receives a grant under section #cdja shall be entitled to an amount of funding under the grant in an amount that is not less than the amount determined under section #cdjc7;a7 with respect to such city or county4 7#d7 ,independent city ,independent cities that are not located within the territory of a county shall be treated as eligible counties for purposes of this subtitle4 7#e7 ,political subdivisions ,with respect to ,states that do not have a local county system of governance1 the ,secretary shall determine the local political subdivisions within such ,states that are eligible to receive a grant under section #cdja and such subdivisions shall be treated as eligible counties for purposes of this subtitle4 7#f7 ,determinations where there is a lack of data ,the ,secretary shall establish eligibility and allocation criteria related to the prevalence of drug overdose deaths1 the mortality rate from drug overdoses1 and that provides an equivalent measure of need for funding for cities and counties for which the data described in paragraph 7#a77;,a7 or 7#b77;,d77i7 is not available4 7#g7 ,study ,not later than #c years after the date of enactment of this title1 the ,comptroller ,general shall conduct a study to determine whether the data utilized for purposes of paragraph 7#a77;,a7 provides the most precise measure of local area need related to substance use and addiction prevalence and whether additional data would provide more precise measures of substance use and addiction prevalence in local areas4 ,such study shall identify barriers to collecting or analyzing such data1 and make recommendations for revising the indicators used under such paragraph to determine eligibility in order to direct funds to the local areas in most need of funding to provide assistance related to substance use and addiction4 7#h7 ,reference ,for purposes of this subtitle1 the term eligible local area includes-- 7,a7 a city or county described in paragraph 7#a72 7,b7 multiple contiguous counties described in paragraph 7#b72 7,c7 an independent locality described in paragraph 7#c72 7,d7 an independent city described in paragraph 7#d72 and 7,e7 a political subdivision described in paragraph 7#e74 7c7 ,administration 7#a7 ,in general ,assistance made available under a grant awarded under this section shall be directed to the chief elected official of the eligible local area who shall administer the grant funds4 7#b7 ,multiple contiguous counties 7,a7 ,in general ,except as provided in subparagraph 7,b71 in the case of an eligible county described in subsection 7b77#b71 assistance made available under a grant awarded under this section shall be directed to the chief elected official of the particular county designated in the application submitted for the grant under section #cdjd4 ,such chief elected official shall be the administrator of the grant4 7,b7 ,state administration ,notwithstanding subparagraph 7,a71 the eligible county described in subsection 7b77#b7 may elect to designate the chief elected ,state official of the ,state in which the eligible county is located as the administrator of the grant funds4 #cdjb4 ,planning council 7a7 ,establishment ,to be eligible to receive a grant under section #cdja1 the chief elected official of the eligible local area shall establish or designate a substance use disorder treatment and services planning council that shall1 to the maximum extent practicable-- 7#a7 be representative of the demographics of the population of individuals with substance use disorder in the area2 and 7#b7 include representatives of-- 7,a7 health care providers1 including federally qualified health centers1 rural health clinics1 ,indian health programs as defined in section #d of the ,indian ,health ,care ,improvement ,act1 urban ,indian organizations as defined in section #d of the ,indian ,health ,care ,improvement ,act1 ,native ,hawaiian organizations as defined in section #ab of the ,native ,hawaiian ,health ,care ,act of #aihh1 and facilities operated by the ,department of ,veterans ,affairs2 7,b7 community-based health1 harm reduction1 or addiction service organizations1 including1 where applicable1 representatives of ,drug ,free ,communities ,coalition grantees2 7,c7 social service providers1 including providers of housing and homelessness services and recovery residence providers2 7,d7 mental health care providers2 7,e7 local public health agencies2 7,f7 law enforcement officials1 including officials from ,high ,intensity ,drug ,trafficking ,area program1 where applicable2 7,g7 affected communities1 including individuals with substance use disorder or a history of substance use disorder1 including individuals in recovery from substance use disorders2 7,h7 ,state governments1 including the ,state ,medicaid agency and the ,single ,state ,agency for ,substance ,abuse ,services2 7,i7 local governments2 7,j7 non-elected community leaders2 7,k7 substance use disorder treatment providers2 7,l7 ,indian tribes and tribal organizations as defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act2 7,m7 urban ,indians as defined in section #d of the ,indian ,health ,care ,improvement ,act2 7,n7 historically underserved groups and subpopulations2 7,o7 individuals who were formerly incarcerated2 7,p7 organizations serving individuals who are currently or were formerly incarcerated2 7,q7 representatives of ,federal agencies2 7,r7 representatives of organizations that provide services to youth at risk of substance use2 7,s7 representatives of medical examiners or coroners2 7,t7 representatives of labor unions and the workplace community2 and 7,u7 representatives of local fire departments and emergency medical services4 7b7 ,method of providing for council 7#a7 ,in general ,in providing for a council for purposes of subsection 7a71 the chief elected official of the eligible local area may establish the council directly or designate an existing entity to serve as the council1 subject to paragraph 7#b74 7#b7 ,consideration regarding designation of council ,in making a determination of whether to establish or designate a council under paragraph 7#a71 the chief elected official shall give priority to the designation of an existing entity that has demonstrated experience in the provision of health and support services to individuals with substance use disorder within the eligible local area1 that has a structure that recognizes the ,federal trust responsibility when spending ,federal health care dollars1 and that has demonstrated a commitment to respecting the obligation of government agencies using ,federal dollars to consult with ,indian tribes and confer with ,urban ,indian health programs4 7#c7 ,joint council ,the ,secretary shall establish a process to permit an eligible local area that is not contiguous with any other eligible local area to form a joint planning council with such other eligible local area or areas1 as long as such areas are located in geographical proximity to each other1 as determined by the ,secretary1 and submit a joint application under section #cdjd4 7#d7 ,joint council across ,state lines ,eligible local areas may form a joint planning council with other eligible local areas across ,state lines if such areas are located in geographical proximity to each other1 as determined by the ,secretary1 submit a joint application under section #cdjd1 and establish intergovernmental agreements to allow the administration of the grant across ,state lines4 7c7 ,membership ,members of the planning council established or designated under subsection 7a7 shall-- 7#a7 be nominated and selected through an open process2 7#b7 elect from among their membership a chair and vice chair2 7#c7 include at least one representative from ,indian tribes located within any eligible local area that receives funding under the grant program established in section #cdja2 and 7#d7 serve no more than #c consecutive years on the planning council4 7d7 ,membership terms ,members of the planning council established or designated under subsection 7a7 may serve additional terms if nominated and selected through the process established in subsection 7c77#a74 7e7 ,duties ,the planning council established or designated under subsection 7a7 shall-- 7#a7 establish priorities for the allocation of grant funds within the eligible local area that emphasize reducing drug overdose and substance use disorder through evidence-based interventions in both community and criminal justice settings and that are based on-- 7,a7 the use by the grantee of substance use disorder treatment and intervention strategies that comply with best practices identified by the ,secretary2 7,b7 the demonstrated or probable cost-effectiveness of proposed substance use disorder treatment services2 7,c7 the health priorities of the communities within the eligible local area that are affected by substance use2 7,d7 the priorities and needs of individuals with substance use disorder2 and 7,e7 the availability of other governmental and nongovernmental services2 7#b7 ensure the use of grant funds are consistent with any existing ,state or local plan regarding the provision of substance use disorder treatment services to individuals with substance use disorder2 7#c7 in the absence of a ,state or local plan1 work with local public health agencies to develop a comprehensive plan for the organization and delivery of substance use disorder treatment services2 7#d7 regularly assess the efficiency of the administrative mechanism in rapidly allocating funds to support evidence-based substance use disorder treatment services in the areas of greatest need within the eligible local area2 7#e7 work with local public health agencies to determine the size and demographics of the population of individuals with substance use disorders and the types of substance use that are most prevalent in the eligible local area2 7#f7 work with local public health agencies to determine the needs of such population1 including the need for substance use disorder treatment services2 7#g7 work with local public agencies to determine the disparities in access to services among affected subpopulations and historically underserved communities1 including infrastructure and capacity shortcomings of providers that contribute to these disparities2 7#h7 work with local public agencies to establish methods for obtaining input on community needs and priorities1 including by partnering with organizations that serve targeted communities experiencing high opioid related health disparities to gather data using culturally attuned data collection methodologies2 7#i7 coordinate with ,federal grantees that provide substance use disorder treatment services within the eligible local area2 and 7#aj7 annually assess the effectiveness of the substance use disorder treatment services being supported by the grant received by the eligible local area1 including-- 7,a7 reductions in the rates of overdose and death from substance use disorders2 7,b7 rates of discontinuation from substance use disorder treatment services2 7,c7 long-term outcomes among individuals receiving treatment for substance use disorders2 and 7,d7 the availability of substance use disorder treatment services needed by individuals with substance use disorders over their lifetimes4 7f7 ,conflicts of interest 7#a7 ,in general ,the planning council under subsection 7a7 may not be directly involved in the administration of a grant under section #cdja4 7#b7 ,required agreements ,an individual may serve on the planning council under subsection 7a7 only if the individual agrees that if the individual has a financial interest in an entity1 if the individual is an employee of a public or private entity1 or if the individual is a member of a public or private organization1 and such entity or organization is seeking amounts from a grant under section #cdja1 the individual will not1 with respect to the purpose for which the entity seeks such amounts1 participate 7directly or in an advisory capacity7 in the process of selecting entities to receive such amounts for such purpose4 7g7 ,grievance procedures ,a planning council under subsection 7a7 shall develop procedures for addressing grievances with respect to funding under this subtitle1 including procedures for submitting grievances that cannot be resolved to binding arbitration4 ,such procedures shall be described in the by-laws of the planning council4 7h7 ,public deliberations ,with respect to a planning council under subsection 7a71 in accordance with criteria established by the ,secretary1 the following applies3 7#a7 ,the meetings of the council shall be open to the public and shall be held only after adequate notice to the public4 7#b7 ,the records1 reports1 transcripts1 minutes1 agenda1 or other documents which were made available to or prepared for or by the council shall be available for public inspection and copying at a single location4 7#c7 ,detailed minutes of each meeting of the council shall be kept4 ,the accuracy of all minutes shall be certified to by the chair of the council4 7#d7 ,this subparagraph does not apply to any disclosure of information of a personal nature that would constitute a clearly unwarranted invasion of personal privacy1 including any disclosure of medical information or personnel matters4 #cdjc4 ,amount of grant and use of amounts 7a7 ,amount of grant 7#a7 ,grants based on relative need of area 7,a7 ,in general ,in carrying out this subtitle1 the ,secretary shall make a grant for each eligible local area for which an application under section #cdjd has been approved4 ,each such grant shall be made in an amount determined in accordance with paragraph 7#c74 7,b7 ,expedited distribution ,not later than #ij days after an appropriation becomes available to carry out this subtitle for a fiscal year1 the ,secretary shall disburse #ec percent of the amount made available under section #cdjf for carrying out this subtitle for such fiscal year through grants to eligible local areas under section #cdja1 in accordance with subparagraphs 7,c7 and 7,d74 7,c7 ,amount 7i7 ,in general ,subject to the extent of amounts made available in appropriations ,acts1 a grant made for purposes of this subparagraph to an eligible local area shall be made in an amount equal to the product of-- 7,i7 an amount equal to the amount available for distribution under subparagraph 7,b7 for the fiscal year involved2 and 7,,ii7 the percentage constituted by the ratio of the distribution factor for the eligible local area to the sum of the respective distribution factors for all eligible local areas2 which product shall then1 as applicable1 be increased under subparagraph 7,d74 7ii7 ,distribution factor ,for purposes of clause 7i77,,ii71 the term distribution factor means-- 7,i7 an amount equal to-- 7aa7 the estimated number of drug overdose deaths in the eligible local area1 as determined under clause 7iii72 or 7bb7 the estimated number of non-fatal drug overdoses in the eligible local area1 as determined under clause 7iv72 as determined by the ,secretary based on which distribution factor 7item 7aa7 or 7bb77 will result in the eligible local area receiving the greatest amount of funds2 or 7,,ii7 in the case of an eligible local area for which the data described in subclause 7,i7 is not available1 an amount determined by the ,secretary-- 7aa7 based on other data the ,secretary determines appropriate2 and 7bb7 that is related to the prevalence of non-fatal drug overdoses1 drug overdose deaths1 and the mortality rate from drug overdoses and provides an equivalent measure of need for funding4 7iii7 ,number of drug overdose deaths ,the number of drug overdose deaths determined under this clause for an eligible county for a fiscal year for purposes of clause 7ii7 is the number of drug overdose deaths during the most recent #c-year period for which such data are available4 7iv7 ,number of non-fatal drug overdoses ,the number of non-fatal drug overdose deaths determined under this clause for an eligible county for a fiscal year for purposes of clause 7ii7 may be determined by using data including emergency department syndromic data1 visits1 or other emergency medical services for drug-related causes during the most recent #c-year period for which such data are available4 7v7 ,study ,not later than #c years after the date of enactment of this title1 the ,comptroller ,general shall conduct a study to determine whether the data utilized for purposes of clause 7ii7 provide the most precise measure of local area need related to substance use and addiction prevalence in local areas and whether additional data would provide more precise measures of substance use and addiction prevalence in local areas4 ,such study shall identify barriers to collecting or analyzing such data1 and make recommendations for revising the distribution factors used under such clause to determine funding levels in order to direct funds to the local areas in most need of funding to provide substance use disorder treatment services4 7vi7 ,reductions in amounts ,if a local area that is an eligible local area for a year loses such eligibility in a subsequent year based on the failure to meet the requirements of section #cdja7;b77#a77;,a71 such area will remain eligible to receive-- 7,i7 for such subsequent year1 an amount equal to #hj percent of the amount received under the grant in the previous year2 and 7,,ii7 for the second such subsequent year1 an amount equal to #ej percent of the amount received in the such previous year4 7#b7 ,supplemental grants 7,a7 ,in general ,the ,secretary shall disburse the remainder of amounts not disbursed under paragraph 7#a7 for such fiscal year for the purpose of making grants to cities and counties whose application under section #cdjd-- 7i7 contains a report concerning the dissemination of emergency relief funds under paragraph 7#a7 and the plan for utilization of such funds1 if applicable2 7ii7 demonstrates the need in such local area1 on an objective and quantified basis1 for supplemental financial assistance to combat substance use disorder2 7iii7 demonstrates the existing commitment of local resources of the area1 both financial and in-kind1 to combating substance use disorder2 7iv7 demonstrates the ability of the area to utilize such supplemental financial resources in a manner that is immediately responsive and cost effective2 7v7 demonstrates that resources will be allocated in accordance with the local demographic incidence of substance use disorders and drug overdose mortality2 7vi7 demonstrates the inclusiveness of affected communities and individuals with substance use disorders1 including those communities and individuals that are disproportionately affected or historically underserved2 7vii7 demonstrates the manner in which the proposed services are consistent with the local needs assessment and the statewide coordinated statement of need required in section #cdac7;e72 7viii7 demonstrates success in identifying individuals with substance use disorders2 and 7ix7 demonstrates that support for substance use disorder treatment services is organized to maximize the value to the population to be served with an appropriate mix of substance use disorder treatment services and attention to transition in care4 7,b7 ,amount 7i7 ,in general ,the amount of each grant made for purposes of this paragraph shall be determined by the ,secretary4 ,in making such determination1 the ,secretary shall consider-- 7,i7 the rate of drug overdose deaths per #ajj1jjj population in the eligible local area2 and 7,,ii7 the increasing need for substance use disorder treatment services1 including relative rates of increase in the number of drug overdoses or drug overdose deaths1 recent increases in drug overdoses or drug overdose deaths since data was provided under section #cdja7;b71 if applicable4 7ii7 ,demonstrated need ,the factors considered by the ,secretary in determining whether a local area has a demonstrated need for purposes of clause 7i77,,ii7 may include any or all of the following3 7,i7 ,the unmet need for substance use disorder treatment services1 including factors identified in subparagraph 7,b77i77,,ii74 7,,ii7 ,relative rates of increase in the number of drug overdoses or drug overdose deaths4 7,,iii7 ,the relative rates of increase in the number of drug overdoses or drug overdose deaths within new or emerging subpopulations4 7,,iv7 ,the current prevalence of substance use disorders4 7,v7 ,relevant factors related to the cost and complexity of delivering substance use disorder treatment services to individuals in the eligible local area4 7,,vi7 ,the impact of co-morbid factors1 including co-occurring conditions1 determined relevant by the ,secretary4 7,,vii7 ,the prevalence of homelessness among individuals with substance use disorders4 7,,viii7 ,the relevant factors that limit access to health care1 including geographic variation1 adequacy of health insurance coverage1 and language barriers4 7,,ix7 ,the impact of a decline in the amount received pursuant to paragraph 7#a7 on substance use disorder treatment services available to all individuals with substance use disorders identified and eligible under this subtitle4 7,x7 ,the increasing incidence in conditions related to substance use1 including hepatitis ,c1 human immunodeficiency virus1 hepatitis ,b and other infections associated with injection drug use4 7,c7 ,application of provisions ,a local area that receives a grant under this paragraph-- 7i7 shall use amounts received in accordance with subsection 7b72 7ii7 shall not have to meet the eligible criteria in section #cdja7;b72 and 7iii7 shall not have to establish a planning council under section #cdjb4 7#c7 ,amount of grant to tribal governments 7,a7 ,indian tribes ,in this section1 the term ,indian tribe has the meaning given such term in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7,b7 ,formula grants ,the ,secretary1 acting through the ,indian ,health ,service1 shall use #aj percent of the amount available under section #cdjf for each fiscal year to provide formula grants to ,indian tribes disproportionately affected by substance use1 in an amount determined pursuant to a formula and eligibility criteria developed by the ,secretary in consultation with ,indian tribes1 for the purposes of addressing substance use4 7,c7 ,use of amounts ,notwithstanding any requirements in this section1 an ,indian tribe may use amounts provided under grants awarded under this paragraph for the uses identified in subsection 7b7 and any other activities determined appropriate by the ,secretary1 in consultation with ,indian tribes4 7b7 ,use of amounts 7#a7 ,requirements ,the ,secretary may not make a grant under section #cdja to an eligible local area unless the chief elected official of the area agrees that-- 7,a7 the allocation of funds and services within the area under the grant will be made in accordance with the priorities established by the substance use disorder treatment services planning council2 and 7,b7 funds provided under this grant will be expended for-- 7i7 prevention services described in paragraph 7#c72 7ii7 core medical services described in paragraph 7#d72 7iii7 recovery and support services described in paragraph 7#e72 7iv7 early intervention and engagement services described in paragraph 7#f72 7v7 harm reduction services described in paragraph 7#g72 7vi7 financial assistance with health insurance described in paragraph 7#h72 and 7vii7 administrative expenses described in paragraph 7#aj74 7#b7 ,direct financial assistance 7,a7 ,in general ,an eligible local area shall use amounts received under a grant under section #cdja to provide direct financial assistance to eligible entities for the purpose of providing prevention services1 core medical services1 recovery and support services1 harm reduction services1 and early intervention and engagement services4 7,b7 ,appropriate entities ,direct financial assistance may be provided under subparagraph 7,a7 to public or nonprofit private entities1 or private for-profit entities if such entities are the only available provider of quality substance use disorder treatment services in the area4 7#c7 ,prevention services 7,a7 ,in general ,for purposes of this subsection1 the term prevention services means services1 programs1 or multi-sector strategies to prevent substance use disorder 7such as evidence-based education campaigns1 community-based prevention programs1 opioid diversion1 collection and disposal or unused opioids1 and services to at-risk populations74 7,b7 ,limit ,an eligible local area may use not to exceed #bj percent of the amount of the grant under section #cdja for prevention services4 ,an eligible local area may apply to the ,secretary for a waiver of this subparagraph4 7#d7 ,core medical services ,for purposes of this subsection1 the term core medical services means the following evidence-based services provided to individuals with substance use disorder or at risk for developing substance use disorder3 7,a7 ,substance use disorder treatments1 including clinical stabilization services1 withdrawal management and detoxification1 intensive inpatient treatment1 intensive outpatient treatment1 all forms of ,federally-approved medication-assisted treatment1 outpatient treatment1 and residential recovery treatment4 7,b7 ,outpatient and ambulatory health services1 including those administered by ,federally qualified health centers and rural health clinics4 7,c7 ,hospice services4 7,d7 ,mental health services4 7,e7 ,naloxone procurement1 distribution1 and training4 7,f7 ,pharmaceutical assistance and diagnostic testing related to the management of substance-use disorders a co-morbid conditions4 7,g7 ,home and community based health services4 7,h7 ,comprehensive ,case ,management1 including substance use disorder treatment adherence services4 7,i7 ,health insurance enrollment and cost-sharing assistance in accordance with paragraph 7#h74 7#e7 ,recovery and support services ,for purposes of paragraph 7#a77;,b77ii71 the term recovery and support services means services1 subject to the approval of the ,secretary1 that are provided to individuals with substance use disorder1 including residential recovery treatment and housing1 including for individuals receiving medication-assisted treatment1 long term recovery services1 #bd_/g hotline crisis center support1 medical transportation services1 respite care for persons caring for individuals with substance use disorder1 child care and family services while an individual is receiving inpatient treatment services or at the time of outpatient services1 outreach services1 peer recovery services1 nutrition services1 and referrals for job training and career services1 housing1 legal services1 and child care and family services4 7#f7 ,early intervention and engagement services ,for purposes of this section1 the term early intervention and engagement services means services to provide rapid access to substance use disorder treatment1 counseling provided to individuals who have misused substances1 who have experienced an overdose1 or are at risk of developing substance use disorder1 and the provision of referrals to facilitate the access of such individuals to core medical services or recovery and support services4 ,the entities through which such services may be provided include emergency rooms1 fire departments and emergency medical services1 detention facilities1 homeless shelters1 law enforcement agencies1 health care points of entry specified by eligible local areas1 ,federally qualified health centers1 and rural health clinics4 7#g7 ,harm reduction services ,for purposes of this section1 the term harm reduction services means evidence-based services provided to individuals engaging in substance use that reduce the risk of infectious disease transmission1 overdose1 or death1 including by increasing access to health care4 7#h7 ,affordable health insurance coverage ,an eligible local area may use amounts provided under a grant awarded under section #cdja to establish a program of financial assistance to assist eligible individuals with substance use disorder in-- 7,a7 enrolling in health insurance coverage2 or 7,b7 affording health care services1 including assistance paying cost-sharing amounts1 including premiums4 7#i7 ,requirement of status as ,medicaid provider 7,a7 ,provision of service ,subject to paragraph 7#b71 the ,secretary may not make a grant under section #cdja for the provision of substance use disorder treatment services under this section in an eligible local area unless1 in the case of any such service that is available pursuant to the ,state plan approved under title ,,xix of the ,social ,security ,act for the ,state-- 7i7 the political subdivision involved will provide the service directly1 and the political subdivision has entered into a participation agreement under the ,state plan and is qualified to receive payments under such plan2 or 7ii7 the eligible local area involved will enter into an agreement with a public or nonprofit private entity under which the entity will provide the service1 and the entity has entered into such a participation agreement and is qualified to receive such payments4 7,b7 ,waiver 7i7 ,in general ,in the case of an entity making an agreement pursuant to subparagraph 7,a77ii7 regarding the provision of substance use disorder treatment services1 the requirement established in such subparagraph shall be waived by the substance use planning council for the area involved if the entity does not1 in providing health care services1 impose a charge or accept reimbursement available from any third-party payor1 including reimbursement under any insurance policy or under any ,federal or ,state health benefits program4 7ii7 ,determination ,a determination by the substance use planning council of whether an entity referred to in clause 7i7 meets the criteria for a waiver under such clause shall be made without regard to whether the entity accepts voluntary donations for the purpose of providing services to the public4 7#aj7 ,administration and planning ,an eligible local area shall not use in excess of #aj percent of amounts received under a grant under section #cdja for administration1 accounting1 reporting1 and program oversight functions1 including the development of systems to improve data collection and data sharing4 7#aa7 ,incarcerated individuals ,amounts received under a grant under section #cdja may be used to provide substance use disorder treatment services to currently incarcerated individuals4 #cdjd4 ,application 7a7 ,in general ,to be eligible to receive a grant under section #cdja1 an eligible local area shall prepare and submit to the ,secretary an application in such form1 and containing such information1 as the ,secretary shall require1 including-- 7#a7 a complete accounting of the disbursement of any prior grants received under this subtitle by the applicant and the results achieved through such disbursements2 7#b7 a demonstration of the extent of local need for the funds under the grant and a plan for proposed substance use disorder treatment services that is consistent with local needs1 including a comprehensive plan for the use of the grant funds developed by the planning council established under section #cdjb1 except that the planning council requirement shall not apply with respect to areas receiving supplemental grant funds under section #cdjc7;a77#b72 7#c7 a demonstration that the area will use funds in a manner that provides substance use disorder treatment services compliant with the evidence-based standards developed in accordance with section #cdcd1 including all forms of ,federally-approved medication-assisted treatments2 7#d7 information on the number of individuals likely to be served by the funds sought1 including demographic data on the populations to be served2 7#e7 key outcomes that will be measured by all entities that receive assistance1 as well as an explanation of how the outcomes will be measured2 7#f7 a demonstration that resources provided under the grant will be allocated in accordance with the local demographic incidence of substance use1 including allocations for services for children1 youths1 and women2 7#g7 a demonstration that funds received from a grant under this subtitle in any prior year were expended in accordance with the priorities established by the planning council2 7#h7 a demonstration that at least one representative from ,indian tribes located within any eligible local area are included in the membership of a planning council2 7#i7 a demonstration that the confidentiality of individuals receiving substance use disorder treatment services will be maintained in a manner not inconsistent with applicable law2 and 7#aj7 an explanation of how income1 asset1 and medical expense criteria will be established and applied to those who qualify for assistance under the program under this subtitle4 7b7 ,assurances ,to be eligible to receive a grant under section #cdja1 the application submitted by the eligible local area shall include assurances adequate to ensure-- 7#a7 that funds received under the grant will be utilized to supplement not supplant other ,state or local funds made available in the year for which the grant is awarded to provide substance use disorder treatment services2 7#b7 that the political subdivisions within the eligible local area will maintain the level of expenditures by such political subdivisions for substance use-related services at a level that is equal to the level of such expenditures by such political subdivisions for the preceding fiscal year2 7#c7 that political subdivisions within the eligible local area will not use funds received under a grant awarded under section #cdja in maintaining the level of substance use disorder treatment services as required in paragraph 7#b72 7#d7 that substance use disorder treatment services provided with assistance made available under the grant will be provided without regard-- 7,a7 to the ability of the individual to pay for such services2 and 7,b7 to the current or past health condition of the individual to be served2 7#e7 that substance use disorder treatment services will be provided in a setting that is accessible to low-income individuals with substance use disorder1 and to individuals with substance use disorder residing in rural areas2 7#f7 that a program of outreach will be provided to low-income individuals with substance use disorder to inform such individuals of substance use disorder treatment services1 and to individuals with substance use disorder residing in rural areas2 and 7#g7 that funds received under a grant awarded under this subtitle will not be utilized to make payments for any item or service to the extent that payment has been made1 or can reasonably be expected to be made1 with respect to that item or service under any ,state compensation program1 under an insurance policy1 or under any ,federal or ,state health benefits program 7except for a program administered by1 or providing the services of1 the ,indian ,health ,service74 7c7 ,requirements regarding imposition of charges for services 7#a7 ,in general ,the ,secretary may not make a grant under section #cdja to an eligible local area unless the eligible local area provides assurances that in the provision of substance use disorder treatment services with assistance provided under the grant-- 7,a7 in the case of individuals with an income less than or equal to #ach percent of the official poverty level1 the provider will not impose charges on any such individual for the services provided under the grant2 7,b7 in the case of individuals with an income greater than #ach percent of the official poverty level1 the provider will impose a charge on each such individual according to a schedule of charges made available to the public2 7,c7 in the case of individuals with an income greater than #ach percent of the official poverty level but not exceeding #bjj percent of such poverty level1 the provider will not1 for an calendar year1 impose charges in an amount exceeding #e percent of the annual gross income of the individual2 7,d7 in the case of individuals with an income greater than #bjj percent of the official poverty level but not exceeding #cjj percent of such poverty level1 the provider will not1 for any calendar year1 impose charges in an amount exceeding #g percent of the annual gross income of the individual involved2 7,e7 in the case of individuals with an income greater than #cjj percent of the official poverty level1 the provider will not1 for any calendar year1 impose charges in an amount exceeding #ae percent of the annual gross income of the individual involved2 and 7,f7 in the case of eligible ,american ,indian and ,alaska ,native individuals as defined by section #ddg4ej of title #db1 ,code of ,federal ,regulations 7as in effect on ,july #a1 #bjaj71 the provider will not impose any charges for substance use disorder treatment services1 including any charges or cost-sharing prohibited by section #adjb7;d7 of the ,patient ,protection and ,affordable ,care ,act4 7#b7 ,charges ,with respect to compliance with the assurances made under paragraph 7#a71 an eligible local area may1 in the case of individuals subject to a charge-- 7,a7 assess the amount of the charge in the discretion of the area1 including imposing only a nominal charge for the provision of substance use disorder treatment services1 subject to the provisions of the paragraph regarding public schedules and regarding limitations on the maximum amount of charges2 and 7,b7 take into consideration the total medical expenses of individuals in assessing the amount of the charge1 subject to such provisions4 7#c7 ,aggregate charges ,the ,secretary may not make a grant under section #cdja to an eligible local area unless the area agrees that the limitations on charges for substance use disorder treatment services under this subsection applies to the annual aggregate of charges imposed for such services1 however the charges are characterized1 includes enrollment fees1 premiums1 deductibles1 cost sharing1 co-payments1 co-insurance costs1 or any other charges4 7d7 ,indian tribes ,any application requirements for grants distributed in accordance with section #cdjc7;a77#c7 shall be developed by the ,secretary in consultation with ,indian tribes4 #cdje4 ,technical assistance ,the ,secretary shall1 beginning on the date of enactment of this title1 provide technical assistance1 including assistance from other grantees1 contractors or subcontractors under this title to assist newly eligible local areas in the establishment of planning councils and1 to assist entities in complying with the requirements of this subtitle in order to make such areas eligible to receive a grant under this subtitle4 ,the ,secretary may make planning grants available to eligible local areas1 in an amount not to exceed #ge1jjj for any area1 that is projected to be eligible for funding under section #cdja in the following fiscal year4 ,such grant amounts shall be deducted from the first year formula award to eligible local areas accepting such grants4 #cdjf4 ,authorization of appropriations ,there is authorized to be appropriated to carry out this subtitle-- 7#a7 #b1gjj1jjj1jjj for fiscal year #bjai2 7#b7 #b1gjj1jjj1jjj for fiscal year #bjbj2 7#c7 #b1gjj1jjj1jjj for fiscal year #bjba2 7#d7 #b1gjj1jjj1jjj for fiscal year #bjbb2 7#e7 #b1gjj1jjj1jjj for fiscal year #bjbc2 7#f7 #b1gjj1jjj1jjj for fiscal year #bjbd2 7#g7 #b1gjj1jjj1jjj for fiscal year #bjbe2 7#h7 #b1gjj1jjj1jjj for fiscal year #bjbf2 7#i7 #b1gjj1jjj1jjj for fiscal year #bjbg2 and 7#aj7 #b1gjj1jjj1jjj for fiscal year #bjbh4 ,b ,state and ,tribal substance use disorder prevention and intervention grant program #cdaa4 ,establishment of program of grants ,the ,secretary1 acting in coordination with the ,director of the ,office of ,national ,drug ,control ,policy1 shall award grants to ,states1 territories1 and tribal governments for the purpose of addressing substance use within such ,states4 #cdab4 ,amount of grant and use of amounts 7a7 ,amount of grant to ,states and territories 7#a7 ,in general 7,a7 ,expedited distribution ,not later than #ij days after an appropriation becomes available1 the ,secretary shall disburse #ej percent of the amount made available under section #cdae for carrying out this subtitle for such fiscal year through grants to ,states under section #cdaa1 in accordance with subparagraphs 7,b7 and 7,c74 7,b7 ,minimum allotment ,subject to the amount made available under section #cdae1 the amount of a grant under section #cdaa for-- 7i7 each of the #ej ,states1 the ,district of ,columbia1 and ,puerto ,rico for a fiscal year shall be the greater of-- 7,i7 #b1jjj1jjj2 or 7,,ii7 an amount determined under the subparagraph 7,c72 and 7ii7 each territory other than ,puerto ,rico for a fiscal year shall be the greater of-- 7,i7 #ejj1jjj2 or 7,,ii7 an amount determined under the subparagraph 7,c74 7,c7 ,determination 7i7 ,formula ,for purposes of subparagraph 7,b71 the amount referred to in this subparagraph for a ,state 7including a territory7 for a fiscal year is-- 7,i7 an amount equal to the amount made available under section #cdae for the fiscal year involved for grants pursuant to subparagraph 7,b72 and 7,,ii7 the percentage constituted by the sum of-- 7aa7 the product of #j4he and the ratio of the ,state distribution factor for the ,state or territory to the sum of the respective distribution factors for all ,states2 and 7bb7 the product of #j4ae and the ratio of the non-local distribution factor for the ,state or territory 7as determined under clause 7iv77 to the sum of the respective non-local distribution factors for all ,states or territories4 7ii7 ,state distribution factor ,for purposes of clause 7i77,,ii77aa71 the term ,state distribution factor means an amount equal to-- 7,i7 the estimated number of drug overdose deaths in the ,state1 as determined under clause 7iii72 or 7,,ii7 the number of non-fatal drug overdoses in the ,state1 as determined under clause 7iv72 as determined by the ,secretary based on which distribution factor 7subclause 7,i7 or 7,,ii77 will result in the ,state receiving the greatest amount of funds4 7iii7 ,number of drug overdoses ,for purposes of clause 7ii71 the number of drug overdose deaths determined under this clause for a ,state for a fiscal year is the number of drug overdose deaths during the most recent #c-year period for which such data are available4 7iv7 ,number of non-fatal drug overdoses ,for purposes of clause 7ii71 the number of non-fatal drug overdose deaths determined under this clause for ,state for a fiscal year for purposes of clause 7ii7 may be determined by using data including emergency department syndromic data1 visits1 or other emergency medical services for drug-related causes during the most recent #c-year period for which such data are available4 7v7 ,non-local distribution factors ,for purposes of clause 7i77,,ii77bb71 the term non-local distribution factor means an amount equal to the sum of-- 7,i7 the number of drug overdoses deaths in the ,state involved1 as determined under clause 7iii71 or the number of non-fatal drug overdoses in the ,state1 based on the criteria used by the ,state under clause 7ii72 less 7,,ii7 the total number of drug overdose deaths or non-fatal drug overdoses that are within areas in such ,state or territory that are eligible counties under section #cdja4 7vi7 ,study ,not later than #c years after the date of enactment of this title1 the ,comptroller ,general shall conduct a study to determine whether the data utilized for purposes of clause 7ii7 provides the most precise measure of ,state need related to substance use and addiction prevalence and whether additional data would provide more precise measures the levels of substance use and addiction prevalent in ,states4 ,such study shall identify barriers to collecting or analyzing such data1 and make recommendations for revising the distribution factors used under such clause to determine funding levels in order to direct funds to the ,states in most need of funding to provide substance use disorder treatment services4 7#b7 ,supplemental grants 7,a7 ,in general ,subject to subparagraph 7,c71 the ,secretary shall disburse the remainder of amounts not disbursed under paragraph 7#a7 for such fiscal year for the purpose of making grants to ,states whose application-- 7i7 contains a report concerning the dissemination of emergency relief funds under paragraph 7#a7 and the plan for utilization of such funds2 7ii7 demonstrates the need in such ,state1 on an objective and quantified basis1 for supplemental financial assistance to combat substance use disorder2 7iii7 demonstrates the existing commitment of local resources of the ,state1 both financial and in-kind1 to combating substance use disorder2 7iv7 demonstrates the ability of the ,state to utilize such supplemental financial resources in a manner that is immediately responsive and cost effective2 7v7 demonstrates that resources will be allocated in accordance with the local demographic incidence of substances use disorders and drug overdose mortality2 7vi7 demonstrates the inclusiveness of affected communities and individuals with substance use disorders1 including those communities and individuals that are disproportionately affected or historically underserved2 7vii7 demonstrates the manner in which the proposed services are consistent with the local needs assessment and the statewide coordinated statement of need required under section #cdac7;e72 7viii7 demonstrates success in identifying individuals with substance use disorders2 and 7ix7 demonstrates that support for substance use disorder treatment services is organized to maximize the value to the population to be served with an appropriate mix of substance use disorder treatment services and attention to transition in care4 7,b7 ,amount 7i7 ,in general ,the amount of each grant made for purposes of this paragraph shall be determined by the ,secretary4 ,in making such determination1 the ,secretary shall consider3 7,i7 the rate of drug overdose deaths per #ajj1jjj population in the ,state2 and 7,,ii7 the increasing need for substance use disorder treatment services1 including relative rates of increase in the number of drug overdoses or drug overdose deaths1 or recent increases in drug overdoses or drug overdose deaths since the data was reported under section #cdac4 7ii7 ,demonstrated need ,the factors considered by the ,secretary in determining whether a ,state has a demonstrated need for purposes of subparagraph 7,a77ii7 may include any or all of the following3 7,i7 ,the unmet need for such services1 including the factors identified in clause 7i77,,ii74 7,,ii7 ,relative rates of increase in the number of drug overdoses or drug overdose deaths4 7,,iii7 ,the relative rates of increase in the number of drug deaths within new or emerging subpopulations4 7,,iv7 ,the current prevalence of substance use disorders4 7,v7 ,relevant factors related to the cost and complexity of delivering substance use disorder treatment services to individuals in the ,state4 7,,vi7 ,the impact of co-morbid factors1 including co-occurring conditions1 determined relevant by the ,secretary4 7,,vii7 ,the prevalence of homelessness among individuals with substance use disorder4 7,,viii7 ,the relevant factors that limit access to health care1 including geographic variation1 adequacy of health insurance coverage1 and language barriers4 7,,ix7 ,the impact of a decline in the amount received pursuant to paragraph 7#a7 on substance use disorder treatment services available to all individuals with substance use disorders identified and eligible under this subtitle4 7,x7 ,the increasing incidence in conditions related to substance use1 including hepatitis ,c1 human immunodeficiency virus1 hepatitis ,b and other infections associated with injection drug use4 7,c7 ,model standards 7i7 ,preference ,in determining whether a ,state will receive funds under this paragraph1 except as provided in clause 7ii71 the ,secretary shall give preference to ,states that have adopted the model standards developed in accordance with section #cdcd4 7ii7 ,requirement ,effective beginning in fiscal year #bjbe1 the ,secretary shall not award a grant under this paragraph to a ,state unless that ,state has adopted the model standards developed in accordance with section #cdcd4 7#c7 ,amount of grant to tribal governments 7,a7 ,indian tribes ,in this section1 the term ,indian tribe has the meaning given such term in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7,b7 ,formula grants ,the ,secretary1 acting through the ,indian ,health ,service1 shall use #aj percent of the amount available under section #cdae for each fiscal year to provide formula grants to ,indian tribes in an amount determined pursuant to a formula and eligibility criteria developed by the ,secretary in consultation with ,indian tribes1 for the purposes of addressing substance use4 7,c7 ,use of amounts ,notwithstanding any requirements in this section1 an ,indian tribe may use amounts provided under grants awarded under this paragraph for the uses identified in subsection 7b7 and any other activities determined appropriate by the ,secretary1 in consultation with ,indian tribes4 7b7 ,use of amounts 7#a7 ,in general ,a ,state may use amounts provided under grants awarded under section #cdaa for-- 7,a7 prevention services described in paragraph 7#b72 7,b7 core medical services described in paragraph 7#c72 7,c7 recovery and support services described in paragraph 7#d72 7,d7 early intervention and engagement services described in paragraph 7#e72 7,e7 harm reduction services described in paragraph 7#f72 and 7,f7 administrative expenses described in paragraph 7#h74 7#b7 ,prevention services 7,a7 ,in general ,for purposes of this subsection1 the term prevention services means services1 programs1 or multi-sector strategies to prevent substance use disorder 7including evidence-based education campaigns1 community-based prevention programs1 opioid diversion1 collection and disposal of unused opioids1 and services to at-risk populations74 7,b7 ,limit ,a ,state may use not to exceed #bj percent of the amount of the grant under section #cdaa for prevention services4 ,a ,state may apply to the ,secretary for a waiver of this subparagraph4 7#c7 ,core medical services ,for purposes of this subsection1 the term core medical services means the following evidence-based services when provided to individuals with substance use disorder or at risk for developing substance use disorder3 7,a7 ,substance use disorder treatments1 including clinical stabilization services1 withdrawal management and detoxification1 intensive inpatient treatment1 intensive outpatient treatment1 all forms of ,federally-approved medication-assisted treatment1 outpatient treatment1 and residential recovery treatment4 7,b7 ,outpatient and ambulatory health services1 including those administered by ,federally qualified health centers and rural health clinics4 7,c7 ,hospice services4 7,d7 ,mental health services4 7,e7 ,naloxone procurement1 distribution1 and training4 7,f7 ,pharmaceutical assistance related to the management of substance-use disorders and co-morbid conditions4 7,g7 ,home and community based health services4 7,h7 ,comprehensive ,case ,management and care coordination1 including treatment adherence services4 7,i7 ,health insurance enrollment and cost-sharing assistance in accordance with subsection 7e74 7#d7 ,recovery and support services ,for purposes of paragraph 7#a77;,c71 the term recovery and support services means services1 subject to the approval of the ,secretary1 that are provided to individuals with substance use disorder1 including residential recovery treatment and housing1 including for individuals receiving medication-assisted treatment1 long term recovery services1 #bd_/g hotline crisis center services1 medical transportation services1 respite care for persons caring for individuals with substance use disorder1 child care and family services while an individual is receiving inpatient treatment services or at the time of outpatient services1 outreach services1 peer recovery services1 nutrition services1 and referrals for job training and career services1 housing1 legal services1 and child care and family services4 7#e7 ,early intervention and engagement services ,for purposes of this subsection1 the term early intervention and engagement services means services to provide rapid access to substance use disorder treatment services1 counseling provided to individuals who have misused substances1 who have experienced an overdose1 or are at risk of developing substance use disorder1 and the provision of referrals to facilitate the access of such individuals to core medical services or recovery and support services4 ,the entities through which such services may be provided include emergency rooms1 fire departments and emergency medical services1 detention facilities1 homeless shelters1 law enforcement agencies1 health care points of entry specified by eligible areas1 ,federally qualified health centers1 and rural health clinics4 7#f7 ,harm reduction services ,for purposes of this subsection1 the term harm reduction services means evidence-based services provided to individuals engaging in substance use disorder that reduce the risk of infectious disease transmission1 overdose1 or death1 including by increasing access to health care4 7#g7 ,affordable health insurance coverage ,a ,state may use amounts provided under a grant awarded under section #cdaa to establish a program of financial assistance to assist eligible individuals with substance use disorder in-- 7,a7 enrolling in health insurance coverage2 or 7,b7 affording health care services1 including assistance paying cost-sharing amounts1 including premiums4 7#h7 ,administration and planning ,a ,state shall not use in excess of #aj percent of amounts received under a grant under section #cdaa for administration1 accounting1 reporting1 and program oversight functions1 including the development of systems to improve data collection and data sharing4 7#i7 ,incarcerated individuals ,amounts received under a grant under section #cdaa may be used to provide substance use disorder treatment services to currently incarcerated individuals4 #cdac4 ,application and limitation 7a7 ,application ,to be eligible to receive a grant under section #cdaa1 a ,state shall prepare and submit to the ,secretary an application in such form1 and containing such information1 as the ,secretary shall require1 including-- 7#a7 a complete accounting of the disbursement of any prior grants received under this subtitle by the applicant and the results achieved by these expenditures2 7#b7 a comprehensive plan for the use of the grant1 including a demonstration of the extent of local need for the funds sought and a plan for proposed substance use disorder treatment services that is consistent with local needs2 7#c7 a demonstration that the ,state will use funds in a manner that provides substance use disorder treatment services compliant with the evidence-based standards developed in accordance with section #cdcd1 including all ,federally-approved medication-assisted treatments2 7#d7 information on the number of individuals likely to be served by the funds sought1 including demographic data on the populations to be served2 7#e7 an identification of key outcomes that will be measured by all entities that receive assistance1 as well as an explanation of how the outcomes will be measured2 7#f7 a demonstration that resources provided under the grant will be allocated in accordance with the local demographic incidence of substance use1 including allocations for services for children1 youths1 and women2 7#g7 a demonstration that funds received from a grant under this subtitle in any prior year were expended in accordance with ,state priorities2 7#h7 a demonstration that the confidentiality of individuals receiving substance use disorder treatment services will be maintained in a manner not inconsistent with applicable law2 and 7#i7 an explanation of how income1 asset1 and medical expense criteria will be established and applied to those who qualify for assistance under the program4 7b7 ,assurances ,to be eligible to receive a grant under section #cdja1 the application submitted by an eligible ,state shall include assurances adequate to ensure-- 7#a7 that funds received under the grant will be utilized to supplement not supplant other ,state or local funds made available in the year for which the grant is awarded to provide substance use disorder treatment services to individuals with substance use disorder2 7#b7 that the political subdivisions within the ,state will maintain the level of expenditures by such political subdivisions for substance use disorder treatment services at a level that is equal to the level of such expenditures by such political subdivisions for the preceding fiscal year2 7#c7 that political subdivisions within the ,state will not use funds received under a grant awarded under section #cdaa in maintaining the level of substance use disorder treatment services as required in paragraph 7#b72 7#d7 that substance use disorder treatment services provided with assistance made available under the grant will be provided without regard-- 7,a7 to the ability of the individual to pay for such services2 and 7,b7 to the current or past health condition of the individual to be served2 7#e7 that substance use disorder treatment services will be provided in a setting that is accessible to low-income individuals with substance use disorders and to individuals with substance use disorders residing in rural areas2 7#f7 that a program of outreach will be provided to low-income individuals with substance use disorders to inform such individuals of substance use disorder treatment services and to individuals with substance use disorders residing in rural areas2 7#g7 that ,indian tribes are included in planning for the use of grant funds and that the ,federal trust responsibility is upheld at all levels of program administration2 and 7#h7 that funds received under a grant awarded under this section will not be utilized to make payments for any item or service to the extent that payment has been made1 or can reasonably be expected to be made1 with respect to that item or service under a ,state compensation program1 under an insurance policy1 or under any ,federal or ,state health benefits program 7except for a program administered by or providing the services of the ,indian ,health ,service74 7c7 ,medicaid ,,imd waiver application requirement ,a ,state shall not be eligible to receive a grant under this subtitle for a fiscal year unless the ,state-- 7#a7 has in effect for the year a waiver under section #aaae of the ,social ,security ,act 7#db ,u4,s4,c4 #acae7 to provide medical assistance under the ,state plan under title ,,xix of such ,act to individuals who-- 7,a7 have not attained age #fe 7or1 if the ,state provides the medical assistance described in section #aije7;a77#af7 of such ,act1 have attained age #ba but have not attained age #fe72 7,b7 are patients in an institution for mental diseases2 and 7,c7 are eligible for medical assistance under the ,state plan2 or 7#b7 has submitted an application for the year for such a waiver4 7d7 ,requirements regarding imposition of charges for services 7#a7 ,in general ,the ,secretary may not make a grant under section #cdaa to a ,state unless the ,state provides assurances that in the provision of services with assistance provided under the grant-- 7,a7 in the case of individuals with an income less than or equal to #ach percent of the official poverty level1 the provider will not impose charges on any such individual for the services provided under the grant2 7,b7 in the case of individuals with an income greater than #ach percent of the official poverty level1 the provider will impose a charge on each such individual according to a schedule of charges made available to the public2 7,c7 in the case of individuals with an income greater than #ach percent of the official poverty level but not exceeding #bjj percent of such poverty level1 the provider will not1 for an calendar year1 impose charges in an amount exceeding #e percent of the annual gross income of the individual2 7,d7 in the case of individuals with an income greater than #bjj percent of the official poverty level but not exceeding #cjj percent of such poverty level1 the provider will not1 for any calendar year1 impose charges in an amount exceeding #g percent of the annual gross income of the individual involved2 7,e7 in the case of individuals with an income greater than #cjj percent of the official poverty level1 the provider will not1 for any calendar year1 impose charges in an amount exceeding #ae percent of the annual gross income of the individual involved2 and 7,f7 in the case of eligible ,american ,indian and ,alaska ,native individuals as defined by section #ddg4ej of title #db1 ,code of ,federal ,regulations 7as in effect on ,july #a1 #bjaj71 the provider will not impose any charges for substance use disorder treatment services1 including any charges or cost-sharing prohibited by section #adjb7;d7 of the ,patient ,protection and ,affordable ,care ,act4 7#b7 ,charges ,with respect to compliance with the assurances made under paragraph 7#a71 a ,state may1 in the case of individuals subject to a charge-- 7,a7 assess the amount of the charge in the discretion of the ,state1 including imposing only a nominal charge for the provision of services1 subject to the provisions of the paragraph regarding public schedules and regarding limitations on the maximum amount of charges2 and 7,b7 take into consideration the total medical expenses of individuals in assessing the amount of the charge1 subject to such provisions4 7#c7 ,aggregate charges ,the ,secretary may not make a grant under section #cdaa to a ,state unless the ,state agrees that the limitations on charges for substance use disorder treatment services under this subsection applies to the annual aggregate of charges imposed for such services1 however the charges are characterized1 includes enrollment fees1 premiums1 deductibles1 cost sharing1 co-payments1 co-insurance costs1 or any other charges4 7e7 ,statewide coordinated statement of need ,a ,state shall not be eligible to receive a grant under this subtitle for a fiscal year unless the ,state develops and publishes a statewide coordinated statement of need1 including a demonstration of the extent of ,state need for assistance in addressing addiction and substance use disorder in the ,state and identifying priorities for the delivery of essential services to individuals with substance use disorder and their families4 7f7 ,indian tribes ,any application requirements applying to grants distributed in accordance with section #cdab7;c7 shall be developed by the ,secretary in consultation with ,indian tribes4 #cdad4 ,technical assistance ,the ,secretary shall provide technical assistance in administering and coordinating the activities authorized under section #cdab1 including technical assistance for the development of ,state applications for supplementary grants authorized in section #cbab7;a77#b74 #cdae4 ,authorization of appropriations ,there is authorized to be appropriated to carry out this subtitle-- 7#a7 #d1jjj1jjj1jjj for fiscal year #bjai2 7#b7 #d1jjj1jjj1jjj for fiscal year #bjbj2 7#c7 #d1jjj1jjj1jjj for fiscal year #bjba2 7#d7 #d1jjj1jjj1jjj for fiscal year #bjbb2 7#e7 #d1jjj1jjj1jjj for fiscal year #bjbc2 7#f7 #d1jjj1jjj1jjj for fiscal year #bjbd2 7#g7 #d1jjj1jjj1jjj for fiscal year #bjbe2 7#h7 #d1jjj1jjj1jjj for fiscal year #bjbf2 7#i7 #d1jjj1jjj1jjj for fiscal year #bjbg2 and 7#aj7 #d1jjj1jjj1jjj for fiscal year #bjbh4 ,c ,other grant program #cdba4 ,establishment of grant program 7a7 ,in general ,the ,secretary shall award grants to public1 nonprofit1 and ,native entities for the purpose of funding core medical services1 recovery and support services1 harm reduction services1 administrative expenses1 and early intervention and engagement services in accordance with this section4 7b7 ,eligibility 7#a7 ,entities ,public1 nonprofit1 or ,native entities eligible to receive a grant under subsection 7a7 may include-- 7,a7 federally qualified health centers under section #aije7l77#b77;,b7 of the ,social ,security ,act2 7,b7 family planning clinics2 7,c7 rural health clinics2 7,d7 ,native entities1 including ,indian health programs as defined in section #d of the ,indian ,health ,care ,improvement ,act1 urban ,indian organizations as defined in section #d of the ,indian ,health ,care ,improvement ,act1 and ,native ,hawaiian organizations as defined in section #ab of the ,native ,hawaiian ,health ,care ,act of #aihh2 7,e7 community-based organizations1 clinics1 hospitals1 and other health facilities that provide substance use disorder treatment services2 7,f7 other nonprofit entities that provide substance use disorder treatment services2 and 7,g7 faith based organizations that provide substance use disorder treatment services4 7#b7 ,underserved populations ,entities described in paragraph 7#a7 shall serve underserved populations which may include minority populations and ,indian populations1 ex-offenders1 individuals with comorbidities including ,,hiv_/,,aids1 hepatitis ,b or ,c1 mental illness1 or other behavioral health disorders1 low-income populations1 inner city populations1 and rural populations4 7#c7 ,application ,to be eligible to receive a grant under this section1 a public or nonprofit entity described in this subsection shall prepare and submit to the ,secretary an application in such form1 and containing such information1 as the ,secretary shall require1 including-- 7,a7 a complete accounting of the disbursement of any prior grants received under this subtitle by the applicant and the results achieved by these expenditures2 7,b7 a comprehensive plan for the use of the grant1 including a demonstration of the extent of local need for the funds sought and a plan for proposed substance use disorder treatment services that is consistent with local needs2 7,c7 a demonstration that the grantee will use funds in a manner that provides substance use disorder treatment services compliant with the evidence-based standards developed in accordance with section #cdcd1 including all ,federally-approved medication-assisted treatments2 7,d7 information on the number of individuals likely to be served by the funds sought1 including demographic data on the populations to be served2 7,e7 an identification of key outcomes that will be measured by all entities that receive assistance1 as well as an explanation of how the outcomes will be measured2 7,f7 a demonstration that resources provided under the grant will be allocated in accordance with the local demographic incidence of substance use1 including allocations for services for children1 youths1 and women2 7,g7 a demonstration that the confidentiality of individuals receiving substance use disorder treatment services will be maintained in a manner not inconsistent with applicable law2 and 7,h7 an explanation of how income1 asset1 and medical expense criteria will be established and applied to those who qualify for assistance under the program4 7c7 ,requirement of status as ,medicaid provider 7#a7 ,provision of service ,subject to paragraph 7#b71 the ,secretary may not make a grant under this section for the provision of substance use disorder treatment services under this section in a ,state unless1 in the case of any such service that is available pursuant to the ,state plan approved under title ,,xix of the ,social ,security ,act for the ,state-- 7,a7 the political subdivision involved will provide the substance use disorder treatment service directly1 and the political subdivision has entered into a participation agreement under the ,state plan and is qualified to receive payments under such plan2 or 7,b7 the political subdivision involved will enter into an agreement with a public or nonprofit private entity under which the entity will provide the substance use disorder treatment service1 and the entity has entered into such a participation agreement and is qualified to receive such payments4 7#b7 ,waiver 7,a7 ,in general ,in the case of an entity making an agreement pursuant to paragraph 7#a77;,b7 regarding the provision of substance use disorder treatment services1 the requirement established in such paragraph shall be waived by the ,state if the entity does not1 in providing such services1 impose a charge or accept reimbursement available from any third-party payor1 including reimbursement under any insurance policy or under any ,federal or ,state health benefits program4 7,b7 ,determination ,a determination by the ,state of whether an entity referred to in subparagraph 7,a7 meets the criteria for a waiver under such subparagraph shall be made without regard to whether the entity accepts voluntary donations for the purpose of providing services to the public4 7d7 ,amount of grant to ,native entities 7#a7 ,indian tribes ,in this section1 the term ,indian tribe has the meaning given such term in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#b7 ,formula grants ,the ,secretary1 acting through the ,indian ,health ,service1 shall use #aj percent of the amount available under section #cdbe for each fiscal year to provide grants to ,native entities in an amount determined pursuant to criteria developed by the ,secretary in consultation with ,indian tribes1 for the purposes of addressing substance use4 7#c7 ,use of amounts ,notwithstanding any requirements in this section1 ,native entities may use amounts provided under grants awarded under this section for the uses identified in section #cdbb and any other activities determined appropriate by the ,secretary1 in consultation with ,indian tribes4 #cdbb4 ,use of amounts 7a7 ,use of funds ,an entity shall use amounts received under a grant under section #cdba to provide direct financial assistance to eligible entities for the purpose of delivering or enhancing-- 7#a7 prevention services described in subsection 7b72 7#b7 core medical services described in subsection 7c72 7#c7 recovery and support services described in subsection 7d72 7#d7 early intervention and engagement services described in subsection 7e72 7#e7 harm reduction services described in subsection 7f72 and 7#f7 administrative expenses described in subsection 7g74 7b7 ,prevention services ,for purposes of this subsection1 the term prevention services means services1 programs1 or multi-sector strategies to prevent substance use disorder1 including evidence-based education campaigns1 community-based prevention programs1 opioid diversion1 collection and disposal of unused opioids1 and services to at-risk populations4 7c7 ,core medical services ,for purposes of this section1 the term core medical services means the following services when provided to individuals with substance use disorder or at risk for developing substance use disorder3 7#a7 ,substance use disorder treatments1 including clinical stabilization services1 withdrawal management and detoxification1 intensive inpatient treatment1 intensive outpatient treatment1 all forms of ,federally-approved medication-assisted treatment1 and residential recovery treatment4 7#b7 ,outpatient and ambulatory health services1 including those administered by federally qualified health centers and rural health clinics4 7#c7 ,hospice services4 7#d7 ,mental health services4 7#e7 ,naloxone procurement1 distribution1 and training4 7#f7 ,pharmaceutical assistance and diagnostic testing related to the management of substance-use disorder and co-morbid conditions4 7#g7 ,home and community based health services4 7#h7 ,comprehensive ,case ,management and care coordination1 including treatment adherence services4 7#i7 ,health insurance enrollment and cost-sharing assistance in accordance with section #cdab4 7d7 ,recovery and support services ,for purposes of subsection 7a77#c71 the term recovery and support services means services1 subject to the approval of the ,secretary1 that are provided to individuals with substance use disorder1 including residential recovery treatment and housing1 including for individuals receiving medication-assisted treatment1 long term recovery services1 #bd_/g hotline services1 medical transportation services1 respite care for persons caring for individuals with substance use disorder1 child care and family services while an individual is receiving inpatient treatment services or at the time of outpatient services1 outreach services1 peer recovery services1 nutrition services1 and referrals for job training and career services1 housing1 legal services1 and child care and family services4 7e7 ,early intervention and engagement services ,for purposes of this section1 the term early intervention and engagement services means services to provide rapid access to substance use disorder treatment services1 counseling provided to individuals who have misused substances1 who have experienced an overdose1 or are at risk of developing substance use disorder and the provision of referrals to facilitate the access of such individuals to core medical services or recovery and support services4 ,the entities through which such services may be provided include emergency rooms1 fire departments and emergency medical services1 detention facilities1 homeless shelters1 law enforcement agencies1 health care points of entry specified by eligible areas1 ,federally qualified health centers1 and rural health clinics4 7f7 ,harm reduction services ,for purposes of this subsection1 the term harm reduction services means evidence-based services provided to individuals engaging in substance use that reduce the risk of infectious disease transmission1 overdose1 or death1 including by increasing access to health care4 7g7 ,administration and planning ,an entity shall not use in excess of #aj percent of amounts received under a grant under section #cdba for administration1 accounting1 reporting1 and program oversight functions1 including for the purposes of developing systems to improve data collection and data sharing4 #cdbc4 ,technical assistance ,the ,secretary may1 directly or through grants or contracts1 provide technical assistance to nonprofit private entities and ,native entities regarding the process of submitting to the ,secretary applications for grants under section #cdba1 and may provide technical assistance with respect to the planning1 development1 and operation of any program or service carried out pursuant to such section4 #cdbd4 ,planning and development grants 7a7 ,in general ,the ,secretary may provide planning grants to public1 nonprofit private1 and ,native entities for purposes of assisting such entities in expanding their capacity to provide substance use disorder treatment services in low-income communities and affected subpopulations that are underserviced with respect to such services4 7b7 ,amount ,a grant under this section may be made in an amount not to exceed #aej1jjj4 #cdbe4 ,authorization of appropriations ,there is authorized to be appropriated to carry out this subtitle-- 7#a7 #ejj1jjj1jjj for fiscal year #bjai2 7#b7 #ejj1jjj1jjj for fiscal year #bjbj2 7#c7 #ejj1jjj1jjj for fiscal year #bjba2 7#d7 #ejj1jjj1jjj for fiscal year #bjbb2 7#e7 #ejj1jjj1jjj for fiscal year #bjbc2 7#f7 #ejj1jjj1jjj for fiscal year #bjbd2 7#g7 #ejj1jjj1jjj for fiscal year #bjbe2 7#h7 #ejj1jjj1jjj for fiscal year #bjbf2 7#i7 #ejj1jjj1jjj for fiscal year #bjbg2 and 7#aj7 #ejj1jjj1jjj for fiscal year #bjbh4 ,d ,miscellaneous provisions #cdca4 ,special projects of national significance 7a7 ,in general ,the ,secretary1 acting in consultation with the ,director of the ,office of ,national ,drug ,control ,policy1 shall award grants to entities to administer special projects of national significance to support the development of innovative and original models for the delivery of substance use disorder treatment services4 7b7 ,grants ,the ,secretary shall award grants under a project under subsection 7a7 to entities eligible for grants under subtitles ,a1 ,b1 and ,c based on newly emerging needs of individuals receiving assistance under this title4 7c7 ,replication ,the ,secretary shall make information concerning successful models or programs developed under this section available to grantees under this title for the purpose of coordination1 replication1 and integration4 ,to facilitate efforts under this subsection1 the ,secretary may provide for peer-based technical assistance for grantees funded under this section4 7d7 ,grants to tribal governments 7#a7 ,indian tribes ,in this section1 the term ,indian tribe has the meaning given such term in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#b7 ,use of funds ,the ,secretary1 acting through the ,indian ,health ,service1 shall use #aj percent of the amount available under this section for each fiscal year to provide grants to ,indian tribes for the purposes of supporting the development of innovative and original models for the delivery of substance use disorder treatment and services1 including the development of culturally-informed care models4 7e7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section-- 7#a7 #ejj1jjj1jjj for fiscal year #bjai2 7#b7 #ejj1jjj1jjj for fiscal year #bjbj2 7#c7 #ejj1jjj1jjj for fiscal year #bjba2 7#d7 #ejj1jjj1jjj for fiscal year #bjbb2 7#e7 #ejj1jjj1jjj for fiscal year #bjbc2 7#f7 #ejj1jjj1jjj for fiscal year #bjbd2 7#g7 #ejj1jjj1jjj for fiscal year #bjbe2 7#h7 #ejj1jjj1jjj for fiscal year #bjbf2 7#i7 #ejj1jjj1jjj for fiscal year #bjbg2 and 7#aj7 #ejj1jjj1jjj for fiscal year #bjbh4 #cdcb4 ,education and training centers 7a7 ,in general ,the ,secretary may make grants and enter into contracts to assist public and nonprofit private entities1 and schools1 and academic health centers in meeting the cost of projects-- 7#a7 to train health personnel1 including practitioners in programs under this title and other community providers1 including counselors1 case managers1 social workers1 peer recovery coaches1 and harm reduction workers1 in the diagnosis1 treatment1 and prevention of substance use disorders1 including measures for the prevention and treatment of co-occurring infectious diseases and other conditions1 and including 7as applicable to the type of health professional involved71 care for women1 pregnant women1 and children2 7#b7 to train the faculty of schools of medicine1 nursing1 public health1 osteopathic medicine1 dentistry1 allied health1 and mental health practice to teach health professions students to screen for and provide for the needs of individuals with substance use disorders or at risk of substance use2 and 7#c7 to develop and disseminate curricula and resource materials relating to evidence-based practices for the screening1 prevention1 and treatment of substance use disorders1 including information about prescribing best practices1 alternative pain therapies1 and ,federally-approved medication-assisted treatment options4 7b7 ,preference in making grants ,in making grants under subsection 7a71 the ,secretary shall give preference to qualified projects that will-- 7#a7 train1 or result in the training of1 health professionals1 including counselors1 case managers1 social workers1 peer recovery coaches1 and harm reduction workers1 who will provide substance use disorder treatments for underserved groups1 including minority individuals and ,indians with substance use disorder and other individuals who are at a high risk of substance use2 7#b7 train1 or result in the training of1 minority health professionals and minority allied health professionals1 including counselors1 case managers1 social workers1 peer recovery coaches1 and harm reduction workers1 to provide substance use disorder treatment for individuals with such disease2 7#c7 train or result in the training of individuals1 including counselors1 case managers1 social workers1 peer recovery coaches1 and harm reduction workers1 who will provide substance use disorder treatment in rural or other areas that are underserved by current treatment structures2 and 7#d7 train or result in the training of health professionals and allied health professionals1 including counselors1 case managers1 social workers1 peer recovery coaches1 and harm reduction workers1 to provide treatment for infectious diseases and mental health conditions co-occurring with substance use disorder4 7c7 ,native education and training centers ,the ,secretary shall use #aj percent of the amount available under subsection 7d7 for each fiscal year to provide grants authorized under this subtitle to-- 7#a7 tribal colleges and universities2 7#b7 ,indian ,health ,service grant funded institutions2 and 7#c7 ,native partner institutions1 including institutions of higher education with medical training programs that partner with one or more ,indian tribes1 tribal organizations1 ,native ,hawaiian organizations1 or tribal colleges and universities to train ,native health professionals that will provide substance use disorder treatment services in ,native communities4 7d7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section-- 7#a7 #djj1jjj1jjj for fiscal year #bjai2 7#b7 #djj1jjj1jjj for fiscal year #bjbj2 7#c7 #djj1jjj1jjj for fiscal year #bjba2 7#d7 #djj1jjj1jjj for fiscal year #bjbb2 7#e7 #djj1jjj1jjj for fiscal year #bjbc2 7#f7 #djj1jjj1jjj for fiscal year #bjbd2 7#g7 #djj1jjj1jjj for fiscal year #bjbe2 7#h7 #djj1jjj1jjj for fiscal year #bjbf2 7#i7 #djj1jjj1jjj for fiscal year #bjbg2 and 7#aj7 #djj1jjj1jjj for fiscal year #bjbh4 #cdcc4 ,other provisions 7a7 ,medication-,assisted treatment ,the ,secretary may not make a grant under this title unless the applicant for the grant agrees to require all entities offering substance use disorder treatment services under the grant to offer all ,federally-approved forms of medication-assisted substance use treatment for the substance use disorders for which the applicant offers treatment4 7b7 ,waiver ,the ,secretary may grant a waiver with respect to any requirement of this title if the grant applicant involved-- 7#a7 submits to the ,secretary a justification containing such information as the ,secretary shall require2 and 7#b7 agrees to require all entities offering substance use disorder treatment services under the grant-- 7,a7 to offer at least two ,federally-approved forms of medication-assisted treatment on site2 7,b7 provide counseling to patients on the benefits and risks of all forms of ,federally-approved medication-assisted treatments2 and 7,c7 maintain an affiliation with a provider that can prescribe or otherwise dispense all other forms of ,federally-approved medication-assisted treatment4 7c7 ,,gao study ,not later than #a year after the date of enactment of this title1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a comprehensive report describing any relationship between substance use rates1 pain management practices of the ,indian ,health ,service1 and patient request denials through the purchased_/referred care program of the ,indian ,health ,service4 #cdcd4 ,standards for substance use disorder treatment and recovery facilities 7a7 ,in general ,not later than #c years after the date of enactment of this title1 the ,secretary1 in consultation with the ,american ,society of ,addiction ,medicine1 shall promulgate model standards for the regulation of substance use disorder treatment services4 7b7 ,contents ,the model standards promulgated under subsection 7a7 shall-- 7#a7 identify the types of providers intended to be covered without regard to whether such providers participate in any ,federal health care program 7as defined in section #aabh;,b7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f777 and shall not include a private practitioner who is already licensed by a ,state medical licensing board and whose practice is limited to outpatient care2 7#b7 require that all substance use disorder treatment services be licensed by the respective ,states for the levels of care which they provide2 7#c7 identify the professional credentials needed by each type of substance use disorder treatment professional2 7#d7 require that patients have access to licensed substance use disorder treatment services1 including health care providers and physicians1 for inpatient and outpatient care2 7#e7 identify and develop strategies for ,states to ensure that all substance use disorder patients receive a medical assessment1 including for co-occurring mental health issues and infectious diseases2 7#f7 require ,states to implement a process to ensure that residential treatment provider qualifications are verified by the single ,state agency serving as the primary regulator in the ,state for substance use disorder treatment services 7as required in paragraph 7#ac77 or by an independent third party with the necessary competencies to use evidence-based patient placement assessment tools and nationally-recognized program standards1 as applicable2 7#g7 ensure that patients receiving substance use disorder treatment have access directly1 by referral1 or in such other manner as determined by the ,secretary1 to all ,federally-approved medication-assisted treatments for substance use disorder2 7#h7 develop standards for data reporting and require compilation of ,statewide reports2 7#i7 develop standards for licensed providers to ensure all patients receive an outpatient treatment and discharge plan2 7#aj7 develop standards for the certification of recovery residences that have an ongoing economic relationship with any commercial substance use disorder treatment service1 including any relationship with any such service that includes receiving or making referrals for substance use disorder treatment1 including-- 7,a7 application1 inspection1 and renewal procedures for recovery residences2 7,b7 fire1 safety1 and health standards2 7,c7 standards for equipping residences with naloxone and training residence owners1 operators1 and employees in the administration of naloxone2 7,d7 standards for recovery residence owners and operators2 and 7,e7 standards to identify1 disqualify from grant funding1 and refer to the appropriate regulatory authority any entity engaged in the soliciting or receiving of a commission1 benefit1 bonus1 rebate1 kickback1 or bribe1 directly or indirectly1 in cash or in kind1 or engaging in any split-fee arrangement1 aimed at inducing the referral of a patient to or from a substance use disorder treatment service2 7#aa7 establish a toll-free telephone number to handle complaints about recovery residences2 7#ab7 establish and maintain on a publicly accessible internet website a list of all recovery residences in the ,state that have a certification in effect in accordance with this section2 7#ac7 require the designation of a single ,state agency to serve as the primary regulator in the ,state for substance use disorder treatment services2 7#ad7 require a single ,state agency to implement a process to ensure that treatment provider assessments for all substance use disorder treatment services1 including levels of care and length-of-stay recommendations1 are verified by an independent third party that has the necessary competencies to use evidence-based patient placement assessment tools and nationally-recognized program standards1 as applicable2 and 7#ae7 consider existing barriers to substance use disorder treatment and service access1 including capacity and infrastructure needs1 as well as access to culturally attuned services4 7c7 ,annual assessment ,beginning with respect to fiscal year #bjba1 the ,secretary shall make a determination with respect to each ,state on whether the ,state has adopted the model standards promulgated in accordance with this section4 7d7 ,quality measures ,the ,secretary shall engage a nonprofit1 non-partisan standards development and quality measurement organization to convene government regulators1 ,state representatives1 consumer representatives1 substance use disorder treatment providers1 recovery residence owners and operators1 and purchasers of substance use disorder treatments exercising leadership in quality-based purchasing to develop and annually revise a set of health care quality measures for substance use disorder treatment providers and owners and operators of recovery residences4 #cdce4 ,naloxone distribution program 7a7 ,establishment of program 7#a7 ,in general ,the ,secretary shall provide for the purchase and delivery of ,federally-approved opioid overdose reversal drug products on behalf of each ,state 7or ,indian tribe as defined in section #d of the ,indian ,health ,care ,improvement ,act7 that receives a grant under subtitle ,b4 ,this paragraph constitutes budget authority in advance of appropriations ,acts1 and represents the obligation of the ,federal ,government to provide for the purchase and delivery to ,states of the opioid overdose reversal drug products in accordance with this paragraph4 7#b7 ,special rules where opioid overdose reversal drug products are unavailable ,to the extent that a sufficient quantity of opioid overdose reversal drug products are not available for purchase or delivery under paragraph 7#a71 the ,secretary shall provide for the purchase and delivery of the available opioid overdose reversal drug products in accordance with priorities established by the ,secretary1 with priority given to ,states with at least one local area eligible for funding under section #cdja7;a74 7b7 ,negotiation of contracts with manufacturers 7#a7 ,in general ,for the purpose of carrying out this section1 the ,secretary shall negotiate and enter into contracts with manufacturers of opioid overdose reversal drug products consistent with the requirements of this subsection and1 to the maximum extent practicable1 consolidate such contracting with any other contracting activities conducted by the ,secretary to purchase opioid overdose reversal drug products4 ,the ,secretary may enter into such contracts under which the ,federal ,government is obligated to make outlays1 the budget authority for which is not provided for in advance in appropriations ,acts1 for the purchase and delivery of opioid overdose reversal drug products under subsection 7a74 7#b7 ,authority to decline contracts ,the ,secretary may decline to enter into contracts under this subsection and may modify or extend such contracts4 7#c7 ,contract price 7,a7 ,in general ,the ,secretary1 in negotiating the prices at which opioid overdose reversal drug products will be purchased and delivered from a manufacturer under this subsection1 shall take into account quantities of opioid overdose reversal drug products to be purchased by ,states under the option under paragraph 7#d77;,b74 7,b7 ,negotiation of discounted price for opioid overdose reversal drug products ,with respect to contracts entered into for the purchase of opioid overdose reversal drug products on behalf of ,states under this subsection1 the price for the purchase of such drug product shall be a discounted price negotiated by the ,secretary4 7#d7 ,product dosage ,all opioid overdose reversal products purchased under this section shall contain-- 7,a7 for each dose1 the maximum amount of active pharmaceutical ingredient that acts as an opioid receptor antagonist as recommended by the ,food and ,drug ,administration as an initial dose when administered by one of the approved1 labeled routes of administration in adults2 and 7,b7 a minimum of two doses packaged together4 7#e7 ,quantities and terms of delivery ,under contracts under this subsection-- 7,a7 the ,secretary shall provide1 consistent with paragraph 7#f71 for the purchase and delivery on behalf of ,states and ,indian tribes of quantities of opioid overdose reversal drug products2 and 7,b7 each ,state and ,indian tribe1 at the option of the ,state or tribe1 shall be permitted to obtain additional quantities of opioid overdose reversal drug products 7subject to amounts specified to the ,secretary by the ,state or tribe in advance of negotiations7 through purchasing the opioid overdose reversal drug products from the manufacturers at the applicable price negotiated by the ,secretary consistent with paragraph 7#c71 if the ,state or tribe provides to the ,secretary such information 7at a time and manner specified by the ,secretary1 including in advance of negotiations under paragraph 7#a77 as the ,secretary determines to be necessary1 to provide for quantities of opioid overdose reversal drug products for the ,state or tribe to purchase pursuant to this subsection and to determine annually the percentage of the opioid overdose reversal drug market that is purchased pursuant to this section and this subparagraph4 ,the ,secretary shall enter into the initial negotiations not later than #ahj days after the date of the enactment of this title4 7#f7 ,charges for shipping and handling ,the ,secretary may enter into a contract referred to in paragraph 7#a7 only if the manufacturer involved agrees to submit to the ,secretary such reports as the ,secretary determines to be appropriate to assure compliance with the contract and if1 with respect to a ,state program under this section that does not provide for the direct delivery of qualified opioid overdose reversal drug products1 the manufacturer involved agrees that the manufacturer will provide for the delivery of the opioid overdose reversal drug products on behalf of the ,state in accordance with such program and will not impose any charges for the costs of such delivery 7except to the extent such costs are provided for in the price established under paragraph 7#c774 7#g7 ,multiple suppliers ,in the case of the opioid overdose reversal drug product involved1 the ,secretary may1 as appropriate1 enter into a contract referred to in paragraph 7#a7 with each manufacturer of the opioid overdose reversal drug product that meets the terms and conditions of the ,secretary for an award of such a contract 7including terms and conditions regarding safety and quality74 ,with respect to multiple contracts entered into pursuant to this paragraph1 the ,secretary may have in effect different prices under each of such contracts and1 with respect to a purchase by ,states pursuant to paragraph 7#d77;,b71 each eligible ,state may choose which of such contracts will be applicable to the purchase4 7c7 ,use of opioid overdose reversal drug product list ,beginning not later than one year after the first contract has been entered into under this section1 the ,secretary shall use1 for the purpose of the purchase1 delivery1 and administration of opioid overdose reversal drug products under this section1 the list established 7and periodically reviewed and1 as appropriate1 revised7 by an advisory committee1 established by the ,secretary and located within the ,centers for ,disease ,control and ,prevention1 which considers the cost effectiveness of each opioid overdose reversal drug product4 7d7 ,state distribution of opioid overdose reversal drug products ,states shall distribute opioid overdose reversal drug products received under this section to the following3 7#a7 ,first ,responders1 including-- 7,a7 all ,state1 county1 and local law enforcement departments2 7,b7 all ,tribal police departments2 7,c7 all local fire departments1 including career fire departments1 combination fire departments1 and volunteer fire departments2 and 7,d7 all local emergency medical services organizations1 including volunteer emergency medical services organizations4 7#b7 ,public entities with authority to administer local public health services1 including all local health departments1 for the purposes of making opioid overdose reversal drug products available to-- 7,a7 public and nonprofit entities1 including-- 7i7 community-based organizations that provide substance use disorder treatments or harm reduction services2 7ii7 nonprofit entities that provide substance use disorder treatments or harm reduction services2 and 7iii7 faith based organizations that provide substance use disorder treatments or harm reduction services2 and 7,b7 the general public4 7e7 ,state requirements ,to be eligible to receive opioid overdose reversal drugs under this section1 each ,state shall-- 7#a7 establish a program for distributing opioid overdose reversal drug products to first responders and entities with authority to administer local public health services1 including local health departments2 7#b7 beginning in the second year of the program1 demonstrate a distribution rate of a minimum of #ij percent of the opioid overdose reversal drug products received under this program2 and 7#c7 certify to the ,secretary that the ,state has in place measures that enhance access to opioid overdose reversal drug products1 such as laws that provide civil or disciplinary immunity for medical personnel who prescribe an opioid overdose reversal drug product1 ,good ,samaritan ,laws1 ,third ,party ,prescription ,laws1 ,collaborative ,practice ,agreements1 and ,standing ,orders4 7f7 ,indian tribe requirements ,the ,indian ,health ,service1 in consultation with ,indian tribes1 shall determine any requirements that shall apply to ,indian tribes receiving opioid overdose reversal drug products made available under this section4 7g7 ,definitions ,for purposes of this section3 7#a7 ,career fire department ,the term career fire department means a fire department that has an all-paid force of firefighting personnel other than paid-on-call firefighters4 7#b7 ,collaborative practice agreement ,the term ,collaborative ,practice ,agreement means an agreement under which a pharmacist operates under authority delegated by another licensed practitioner with prescribing authority4 7#c7 ,combination fire department ,the term combination fire department means a fire department that has paid firefighting personnel and volunteer firefighting personnel4 7#d7 ,emergency medical service ,the term emergency medical service means resources used by a public or private nonprofit licensed entity to deliver medical care outside of a medical facility under emergency conditions that occur as a result of the condition of the patient and includes services delivered 7either on a compensated or volunteer basis7 by an emergency medical services provider or other provider that is licensed or certified by the ,state involved as an emergency medical technician1 a paramedic1 or an equivalent professional 7as determined by the ,state74 7#e7 ,good ,samaritan ,law ,the term ,good ,samaritan ,law means a law that provides criminal immunity for a person who administers an opioid overdose reversal drug product1 a person who1 in good faith1 seeks medical assistance for someone experiencing a drug-related overdose1 or a person who experiences a drug-related overdose and is in need of medical assistance and1 in good faith1 seeks such medical assistance1 or is the subject of such a good faith request for medical assistance4 7#f7 ,indians ,the terms ,indian1 ,indian tribe1 tribal organization1 and ,urban ,indian ,health ,program have the meanings given such terms in section #d of the ,indian ,health ,care ,improvement ,act4 7#g7 ,manufacturer ,the term manufacturer means any corporation1 organization1 or institution1 whether public or private 7including ,federal1 ,state1 and local departments1 agencies1 and instrumentalities71 which manufactures1 imports1 processes1 or distributes under its label any opioid overdose reversal drug product4 ,the term manufacture means to manufacture1 import1 process1 or distribute an opioid overdose reversal drug4 7#h7 ,opioid overdose reversal drug product ,the term opioid overdose reversal drug product means a finished dosage form that has been approved by the ,food and ,drug ,administration and that contains an active pharmaceutical ingredient that acts as an opioid receptor antagonist4 ,the term opioid overdose reversal drug product includes a combination product1 as defined in section #c4b7;e7 of title #ba1 ,code of ,federal ,regulations4 7#i7 ,standing order ,the term standing order means a non-patient-specific order covering administration of medication by others to a patient who may be unknown to the prescriber at the time of the order4 7#aj7 ,third party prescription ,the term third party prescription means an order written for medication dispensed to one person with the intention that it will be administered to another person4 7#aa7 ,volunteer fire department ,the term volunteer fire department means a fire department that has an all-volunteer force of firefighting personnel4 7h7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this suction-- 7#a7 #ejj1jjj1jjj for fiscal year #bjai2 7#b7 #ejj1jjj1jjj for fiscal year #bjbj2 7#c7 #ejj1jjj1jjj for fiscal year #bjba2 7#d7 #ejj1jjj1jjj for fiscal year #bjbb2 7#e7 #ejj1jjj1jjj for fiscal year #bjbc2 7#f7 #ejj1jjj1jjj for fiscal year #bjbd2 7#g7 #ejj1jjj1jjj for fiscal year #bjbe2 7#h7 #ejj1jjj1jjj for fiscal year #bjbf2 7#i7 #ejj1jjj1jjj for fiscal year #bjbg2 and 7#aj7 #ejj1jjj1jjj for fiscal year #bjbh4 #cdcf4 ,additional funding for the ,national ,institutes of ,health ,there is authorized to be appropriated to the ,national ,institute of ,health for the purpose of conducting research on addiction and pain related to substance misuse1 including research to develop overdose reversal drug products1 non-addictive drug products for treating pain1 and drug products used to treat substance use disorder-- 7#a7 #a1jjj1jjj1jjj for fiscal year #bjai2 7#b7 #a1jjj1jjj1jjj for fiscal year #bjbj2 7#c7 #a1jjj1jjj1jjj for fiscal year #bjba2 7#d7 #a1jjj1jjj1jjj for fiscal year #bjbb2 7#e7 #a1jjj1jjj1jjj for fiscal year #bjbc2 7#f7 #a1jjj1jjj1jjj for fiscal year #bjbd2 7#g7 #a1jjj1jjj1jjj for fiscal year #bjbe2 7#h7 #a1jjj1jjj1jjj for fiscal year #bjbf2 7#i7 #a1jjj1jjj1jjj for fiscal year #bjbg2 and 7#aj7 #a1jjj1jjj1jjj for fiscal year #bjbh4 #cdcg4 ,additional funding for improved data collection and prevention of infectious disease transmission 7a7 ,data collection ,the ,centers for ,disease ,control and ,prevention shall use a portion of the funding appropriated under this section to ensure that all ,states participate in the ,enhanced ,state ,opioid ,overdose ,surveillance program and to provide technical assistance to medical examiners and coroners to facilitate improved data collection on fatal overdoses through such program4 7b7 ,centers for ,disease ,control and ,prevention ,the ,centers for ,disease ,control and ,prevention shall use amounts appropriated under this section for the purpose of improving data on drug overdose deaths and non-fatal drug overdoses1 surveillance related to addiction and substance use disorder1 and the prevention of transmission of infectious diseases related to substance use4 7c7 ,tribal epidemiology centers ,there shall be made available to the ,indian ,health ,service for the purpose of funding efforts by tribal epidemiology centers to improve data on drug overdose deaths and non-fatal drug overdoses and surveillance related to addiction and substance use disorder1 not less than #a4e percent of the total amount appropriated under this section for each fiscal year4 7d7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section-- 7#a7 #djj1jjj1jjj for fiscal year #bjai2 7#b7 #djj1jjj1jjj for fiscal year #bjbj2 7#c7 #djj1jjj1jjj for fiscal year #bjba2 7#d7 #djj1jjj1jjj for fiscal year #bjbb2 7#e7 #djj1jjj1jjj for fiscal year #bjbc2 7#f7 #djj1jjj1jjj for fiscal year #bjbd2 7#g7 #djj1jjj1jjj for fiscal year #bjbe2 7#h7 #djj1jjj1jjj for fiscal year #bjbf2 7#i7 #djj1jjj1jjj for fiscal year #bjbg2 and 7#aj7 #djj1jjj1jjj for fiscal year #bjbh4 #cdch4 ,definitions ,in this title3 7#a7 ,planning council ,the term planning council means the substance use planning council established under section #cdjb4 7#b7 ,recovery residence ,the term recovery residence means a residential dwelling unit1 or other form of group housing1 that is offered or advertised through any means1 including oral1 written1 electronic1 or printed means1 by any individual or entity as a residence that provides an evidence-based1 peer-supported living environment for individuals undergoing any type of substance use disorder treatment or who have received any type of substance use disorder treatment in the past #c years1 including medication-assisted treatment4 7#c7 ,state 7,a7 ,in general ,the term ,state means each of the #ej ,states1 the ,district of ,columbia1 and each of the territories4 7,b7 ,territories ,the term territory means each of ,american ,samoa1 ,guam1 the ,commonwealth of ,puerto ,rico1 the ,commonwealth of the ,northern ,mariana ,islands1 the ,virgin ,islands1 the ,republic of the ,marshall ,islands1 the ,federated ,states of ,micronesia1 and ,palau4 7#d7 ,substance use disorder treatment 7,a7 ,in general ,the term substance use disorder treatment means an evidence-based1 professionally directed1 deliberate1 and planned regimen including evaluation1 observation1 medical monitoring1 and rehabilitative services and interventions such as pharmacotherapy1 behavioral therapy1 and individual and group counseling1 on an inpatient or outpatient basis1 to help patients with substance use disorder reach recovery4 7,b7 ,types of treatment ,substance use disorder treatments shall include the following3 7i7 ,clinical stabilization services1 which are evidence-based services provided in secure1 acute care facilities 7which may be referred to as addictions receiving facilities7 that1 at a minimum-- 7,i7 provide detoxification and stabilization services2 7,,ii7 are operated #bd hours per day1 #g days per week2 and 7,,iii7 that serve individuals found to be substance use impaired4 ,these can also be referred to as ,addictions receiving facilities4 7ii7 ,withdrawal management and detoxification1 which is a service that is provided on an inpatient or an outpatient basis to assist individuals manage the process of withdrawing from the physiological and psychological effects of substance use disorder4 7iii7 ,intensive inpatient treatment1 which is a service that provides a planned regimen of evidence-based evaluation1 observation1 medical monitoring1 and evidence-based rehabilitative services and interventions such as pharmacotherapy1 behavioral therapy1 and counseling1 #bd hours per day1 #g days per week1 in a highly structured1 residential environment4 7iv7 ,intensive outpatient treatment1 which is a service that provides a planned regimen of evidence-based evaluation1 observation1 medical monitoring1 and evidence-based rehabilitative services and interventions such as pharmacotherapy1 behavioral therapy1 and counseling1 in a structured1 nonresidential environment at a higher level of intensity and duration than outpatient treatment4 7v7 ,medication-assisted treatment1 which is a service that uses ,federally-approved medication as authorized by ,federal and ,state law1 in combination with evidence-based medical1 rehabilitative1 and counseling services1 in the treatment of individuals who suffer from substance use disorder4 7vi7 ,outpatient treatment1 which is a service that provides a planned regimen of evidence-based evaluation1 observation1 medical monitoring1 and evidence-based rehabilitative services and interventions such as pharmacotherapy1 behavioral therapy1 and counseling in a structured1 nonresidential environment by appointment during scheduled operating hours4 7vii7 ,residential recovery treatment1 which is a service that provides a planned regimen of evidence-based evaluation1 observation1 medical monitoring1 and evidence-based rehabilitative services and interventions such as pharmacotherapy1 behavioral therapy1 and counseling provided in a structured1 live-in environment within a nonhospital setting on a #bd-;hours-per-day1 #g-;days-per-week basis4 7,c7 ,limitation ,substance use disorder treatment providers shall not include-- 7i7 prevention only providers2 and 7ii7 a private practitioner who is licensed by a ,state medical licensing board and whose practice is limited to outpatient care4 7#e7 ,substance use disorder treatment services ,the term substance use disorder treatment services means any prevention services1 core medical services1 recovery and support services1 early intervention and engagement services1 and harm reduction services authorized under this title4 4 #d4 ,amendments to the ,controlled ,substances ,act 7a7 ,certifications ,part ,c of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hba et seq47 is amended by adding at the end the following3 #cab4 ,certifications relating to diversion controls and misbranding 7a7 ,definitions ,in this section-- 7#a7 the term covered dispenser-- 7,a7 means a dispenser-- 7i7 that is required to register under section #cjb7;a77#b72 and 7ii7 dispenses a controlled substance in schedule ,,ii2 and 7,b7 does not include a dispenser that is-- 7i7 registered to dispense opioid agonist treatment medication under section #cjc7;g77#a72 and 7ii7 operating in that capacity2 7#b7 the term covered distributor means a distributor-- 7,a7 that is required to register under section #cjb7;a77#a72 and 7,b7 distributes a controlled substance in schedule ,,ii2 7#c7 the term covered manufacturer means a manufacturer-- 7,a7 that is required to register under section #cjb7;a77#a72 and 7,b7 manufactures a controlled substance in schedule ,,ii2 7#d7 the term covered officer1 with respect to a covered person means-- 7,a7 in the case of a covered person that is not an individual-- 7i7 the chief executive officer of the covered person2 7ii7 the president of the covered person2 7iii7 the chief medical officer of the covered person2 and 7iv7 the chief counsel of the covered person2 and 7,b7 in the case of a covered person that is an individual1 that individual2 and 7#e7 the term covered person means a covered dispenser1 a covered distributor1 or a covered manufacturer4 7b7 ,certifications relating to diversion controls ,not later than #ahj days after the date of enactment of this section1 and each year thereafter1 each covered officer of a covered person shall submit to the ,attorney ,general1 for each controlled substance in schedule ,,ii dispensed1 distributed1 or manufactured by the covered person1 a certification-- 7#a7 signed by the covered officer2 and 7#b7 certifying that-- 7,a7 the covered person maintains effective controls against diversion of the controlled substance into channels other than legitimate medical1 scientific1 research1 or industrial channels2 7,b7 all information contained in any record1 inventory1 or report required to be kept or submitted to the ,attorney ,general by the covered person under section #cjg1 or under any regulation issued under that section1 is accurate2 and 7,c7 the covered person is in compliance with all applicable requirements under ,federal law relating to reporting suspicious orders for controlled substances4 7c7 ,certifications relating to misbranding ,not later than #ahj days after the date of enactment of this section1 and each year thereafter1 each covered officer of a covered manufacturer shall submit to the ,attorney ,general1 for each controlled substance in schedule ,,ii manufactured by the covered manufacturer1 a certification-- 7#a7 signed by the covered officer2 and 7#b7 certifying that the controlled substance is not misbranded1 as described in section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb74 4 7b7 ,offenses ,part ,d of title ,,ii of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hda et seq47 is amended by adding at the end the following3 #dbd4 ,certifications by covered officers 7a7 ,definitions ,in this section1 the terms covered dispenser1 covered distributor1 covered manufacturer1 covered officer1 and covered person have the meanings given those terms in section #cab4 7b7 ,offenses 7#a7 ,failure to submit certifications 7,a7 ,certifications relating to diversion controls ,it shall be unlawful for a covered officer of a covered person to fail to submit a certification required under section #cab7;b71 without regard to the state of mind of the covered officer4 7,b7 ,certifications relating to misbranding ,it shall be unlawful for a covered officer of a covered manufacturer to fail to submit a certification required under section #cab7;c71 without regard to the state of mind of the covered officer4 7#b7 ,submission of false certifications 7,a7 ,false certifications relating to diversion controls ,it shall be unlawful for a covered officer of a covered person to submit a certification required under section #cab7;b71 without regard to the state of mind of the covered officer1 that contains a materially false statement or representation relating to the information required to be certified under that section for the year for which the certification is submitted4 7,b7 ,false certifications relating to misbranding ,it shall be unlawful for a covered officer of a covered manufacturer to submit a certification required under section #cab7;c71 without regard to the state of mind of the covered officer1 that contains a materially false statement or representation relating to the misbranding of a controlled substance with respect to the year for which the certification is submitted4 7c7 ,penalties 7#a7 ,civil penalties ,except as provided in paragraph 7#b71 a covered officer who violates subsection 7b7 shall be subject to a civil penalty of not more than #be1jjj4 7#b7 ,criminal penalties ,a covered officer who knowingly violates subsection 7b77#b7 shall be subject to criminal penalties under section #djc7;d74 7d7 ,comprehensive ,addiction ,resources ,fund 7#a7 ,establishment ,there is established in the ,treasury a fund to be known as the ,comprehensive ,addiction ,resources ,fund4 7#b7 ,transfer of amounts ,there shall be transferred to the ,comprehensive ,addiction ,resources ,fund #ajj percent of-- 7,a7 any civil penalty paid to the ,united ,states under this section2 and 7,b7 any fine paid to the ,united ,states under section #djc7;d7 for a knowing violation of subsection 7b77#b7 of this section4 7#c7 ,availability and use of funds ,amounts transferred to the ,comprehensive ,addiction ,fund under paragraph 7#b7 shall-- 7,a7 remain available until expended2 and 7,b7 be made available to supplement amounts appropriated to carry out title ,,xxxiv of the ,public ,health ,service ,act4 4 7c7 ,criminal penalties ,section #djc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hdc7 is amended-- 7#a7 in subsection 7d77#a7-- 7,a7 by inserting or knowingly violates section #dbd7;b77#b7 after any person who violates this section2 and 7,b7 by striking violation of this section and inserting such a violation2 and 7#b7 in subsection 7f7-- 7,a7 in paragraph 7#a71 by striking or #daf and inserting or section #daf1 or knowing violations of section #dbd7;b77#b72 and 7,b7 in paragraph 7#c71 by inserting or knowing violations of section #dbd7;b77#b7 before the period at the end4 7d7 ,technical and conforming amendments ,the table of contents for the ,comprehensive ,drug ,abuse ,prevention and ,control ,act of #aigj 7,public ,law #ia-eac2 #hd ,stat4 #abcf7 is amended-- 7#a7 by inserting after the item relating to section #caa the following3 ,sec4 #cab4 ,certifications relating to diversion controls and misbranding4 2 and 7#b7 by inserting after the item relating to section #dbc the following3 ,sec4 #dbd4 ,certifications by covered officers4 4 7e7 ,effective date ,the amendments made by subsections 7b7 and 7c7 of this section shall take effect on the date that is #ahj days after the date of enactment of this ,act4