,i #aaeth ,,congress #b;d ,session ,h4 ,r4 #f ,,in ,,the ,,house ,,of ,,representatives ,june #ac1 #bjah,mr4 ,walden 7for himself1 ,mr4 ,pallone1 ,mr4 ,brady of ,texas1 ,mr4 ,neal1 ,mr4 ,roe of ,tennessee1 ,mr4 ,shuster1 ,ms4 ,foxx1 ,mr4 ,goodlatte1 ,mr4 ,walz1 ,mr4 ,de,fazio1 and ,mr4 ,burgess7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means1 and the ,judiciary1 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 for opioid use disorder prevention1 recovery1 and treatment1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,substance ,use-,disorder ,prevention that ,promotes ,opioid ,recovery and ,treatment for ,patients and ,communities ,act or the ,,support for ,patients and ,communities ,act4 7b7 ,table of contents ,the table of contents for the ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,title ,i--,medicaid ,provisions to ,address the ,opioid ,crisis ,sec4 #aja4 ,at-risk youth ,medicaid protection4 ,sec4 #ajb4 ,health ,insurance for ,former ,foster ,youth4 ,sec4 #ajc4 ,demonstration project to increase substance use provider capacity under the ,medicaid program4 ,sec4 #ajd4 ,drug management program for at-risk beneficiaries4 ,sec4 #aje4 ,medicaid drug review and utilization4 ,sec4 #ajf4 ,guidance to improve care for infants with neonatal abstinence syndrome and their mothers2 ,,gao study on gaps in ,medicaid coverage for pregnant and postpartum women with substance use disorder4 ,sec4 #ajg4 ,medicaid health homes for opioid-use-disorder ,medicaid enrollees4 ,title ,,ii--,medicare ,provisions to ,address the ,opioid ,crisis ,sec4 #bja4 ,authority not to apply certain ,medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder4 ,sec4 #bjb4 ,encouraging the use of non-opioid analgesics for the management of post-surgical pain4 ,sec4 #bjc4 ,requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the ,welcome to ,medicare initial preventive physical examination4 ,sec4 #bjd4 ,modification of payment for certain outpatient surgical services4 ,sec4 #bje4 ,requiring e-prescribing for coverage of covered part ,d controlled substances4 ,sec4 #bjf4 ,requiring prescription drug plan sponsors under ,medicare to establish drug management programs for at-risk beneficiaries4 ,sec4 #bjg4 ,medicare coverage of certain services furnished by opioid treatment programs4 ,title ,,iii--,other ,health ,provisions to ,address the ,opioid ,crisis ,sec4 #cja4 ,clarifying ,,fda regulation of non-addictive pain and addiction therapies4 ,sec4 #cjb4 ,surveillance and ,testing of ,opioids to ,prevent ,fentanyl ,deaths4 ,sec4 #cjc4 ,allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders4 ,title ,,iv--,offsets ,sec4 #dja4 ,promoting value in ,medicaid managed care4 ,sec4 #djb4 ,extending period of application of ,medicare secondary payer rules for individuals with end stage renal disease4 ,sec4 #djc4 ,requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the ,medicare program4 ,i ,medicaid ,provisions to ,address the ,opioid ,crisis #aja4 ,at-risk youth ,medicaid protection 7a7 ,in general ,section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking and at the end of paragraph 7#hb72 7,b7 by striking the period at the end of paragraph 7#hc7 and inserting 2 and2 and 7,c7 by inserting after paragraph 7#hc7 the following new paragraph3 7#hd7 provide that-- 7,a7 the ,state shall not terminate eligibility for medical assistance under the ,state plan for an individual who is an eligible juvenile 7as defined in subsection 7nn77#b77 because the juvenile is an inmate of a public institution 7as defined in subsection 7nn77#c771 but may suspend coverage during the period the juvenile is such an inmate2 7,b7 in the case of an individual who is an eligible juvenile described in paragraph 7#b77;,a7 of subsection 7nn71 the ,state shall1 prior to the individual's release from such a public institution1 conduct a redetermination of eligibility for such individual with respect to such medical assistance 7without requiring a new application from the individual7 and1 if the ,state determines pursuant to such redetermination that the individual continues to meet the eligibility requirements for such medical assistance1 the ,state shall restore coverage for such medical assistance to such an individual upon the individual's release from such public institution2 and 7,c7 in the case of an individual who is an eligible juvenile described in paragraph 7#b77;,b7 of subsection 7nn71 the ,state shall process any application for medical assistance submitted by1 or on behalf of1 such individual such that the ,state makes a determination of eligibility for such individual with respect to such medical assistance upon release of such individual from such public institution4 2 and 7#b7 by adding at the end the following new subsection3 7nn7 ,juvenile2 eligible juvenile2 public institution ,for purposes of subsection 7a77#hd7 and this subsection3 7#a7 ,juvenile ,the term juvenile means an individual who is-- 7,a7 under #ba years of age2 or 7,b7 described in subsection 7a77#aj77;,a77i77,,ix74 7#b7 ,eligible juvenile ,the term eligible juvenile means a juvenile who is an inmate of a public institution and who-- 7,a7 was determined eligible for medical assistance under the ,state plan immediately before becoming an inmate of such a public institution2 or 7,b7 is determined eligible for such medical assistance while an inmate of a public institution4 7#c7 ,inmate of a public institution ,the term inmate of a public institution has the meaning given such term for purposes of applying the subdivision 7,a7 following paragraph 7#bi7 of section #aije7;a71 taking into account the exception in such subdivision for a patient of a medical institution4 4 7b7 ,no change in exclusion from medical assistance for inmates of public institutions ,nothing in this section shall be construed as changing the exclusion from medical assistance under the subdivision 7,a7 following paragraph 7#bi7 of section #aije7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a771 including any applicable restrictions on a ,state submitting claims for ,federal financial participation under title ,,xix of such ,act for such assistance4 7c7 ,no change in continuity of eligibility before adjudication or sentencing ,nothing in this section shall be construed to mandate1 encourage1 or suggest that a ,state suspend or terminate coverage for individuals before they have been adjudicated or sentenced4 7d7 ,effective date 7#a7 ,in general ,except as provided in paragraph 7#b71 the amendments made by subsection 7a7 shall apply to eligibility of juveniles who become inmates of public institutions on or after the date that is #a year after the date of the enactment of this ,act4 7#b7 ,rule for changes requiring state legislation ,in the case of a ,state plan for medical assistance under title ,,xix of the ,social ,security ,act which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the plan to meet the additional requirements imposed by the amendments made by subsection 7a71 the ,state plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of the enactment of this ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of such session shall be deemed to be a separate regular session of the ,state legislature4 #ajb4 ,health ,insurance for ,former ,foster ,youth 7a7 ,coverage continuity for former foster care children up to age #bf 7#a7 ,in general ,section #aijb7;a77#aj77;,a77i77,,ix7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77i77,,ix77 is amended-- 7,a7 in item 7bb71 by striking are not described in or enrolled under and inserting are not described in and are not enrolled under2 7,b7 in item 7cc71 by striking responsibility of the ,state and inserting responsibility of a ,state2 and 7,c7 in item 7dd71 by striking the ,state plan under this title or under a waiver of the and inserting a ,state plan under this title or under a waiver of such a4 7#b7 ,effective date ,the amendments made by this subsection shall take effect with respect to foster youth who attain #ah years of age on or after ,january #a1 #bjbc4 7b7 ,guidance ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue guidance to ,states1 with respect to the ,state ,medicaid programs of such ,states-- 7#a7 on best practices for-- 7,a7 removing barriers and ensuring streamlined1 timely access to ,medicaid coverage for former foster youth up to age #bf2 and 7,b7 conducting outreach and raising awareness among such youth regarding ,medicaid coverage options for such youth2 and 7#b7 which shall include examples of ,states that have successfully extended ,medicaid coverage to former foster youth up to age #bf4 #ajc4 ,demonstration project to increase substance use provider capacity under the ,medicaid program ,section #aijc of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7 is amended by adding at the end the following new subsection3 7aa7 ,demonstration project ,to increase substance use provider capacity 7#a7 ,in general ,not later than the date that is #ahj days after the date of the enactment of this section1 the ,secretary shall1 in consultation1 as appropriate1 with the ,director of the ,agency for ,healthcare ,research and ,quality and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 conduct a #ed-month demonstration project for the purpose described in paragraph 7#b7 under which the ,secretary shall-- 7,a7 for the first #ah-month period of such project1 award planning grants described in paragraph 7#c72 and 7,b7 for the remaining #cf-month period of such project1 provide to each ,state selected under paragraph 7#d7 payments in accordance with paragraph 7#e74 7#b7 ,purpose ,the purpose described in this paragraph is for each ,state selected under paragraph 7#d7 to increase the treatment capacity of providers participating under the ,state plan 7or a waiver of such plan7 to provide substance use disorder treatment or recovery services under such plan 7or waiver7 through the following activities3 7,a7 ,for the purpose described in paragraph 7#c77;,c77i71 activities that support an ongoing assessment of the behavioral health treatment needs of the ,state1 taking into account the matters described in subclauses 7,i7 through 7,,iv7 of such paragraph4 7,b7 ,activities that1 taking into account the results of the assessment described in subparagraph 7,a71 support the recruitment1 training1 and provision of technical assistance for providers participating under the ,state plan 7or a waiver of such plan7 that offer substance use disorder treatment or recovery services4 7,c7 ,improved reimbursement for and expansion of1 through the provision of education1 training1 and technical assistance1 the number or treatment capacity of providers participating under the ,state plan 7or waiver7 that-- 7i7 are authorized to dispense drugs approved by the ,food and ,drug ,administration for individuals with a substance use disorder who need withdrawal management or maintenance treatment for such disorder2 7ii7 have in effect a registration or waiver under section #cjc7;g7 of the ,controlled ,substances ,act for purposes of dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment and are in compliance with any regulation promulgated by the ,assistant ,secretary for ,mental ,health and ,substance ,use for purposes of carrying out the requirements of such section #cjc7;g72 and 7iii7 are qualified under applicable ,state law to provide substance use disorder treatment or recovery services4 7,d7 ,improved reimbursement for and expansion of1 through the provision of education1 training1 and technical assistance1 the number or treatment capacity of providers participating under the ,state plan 7or waiver7 that have the qualifications to address the treatment or recovery needs of-- 7i7 individuals enrolled under the ,state plan 7or a waiver of such plan7 who have neonatal abstinence syndrome1 in accordance with guidelines issued by the ,american ,academy of ,pediatrics and ,american ,college of ,obstetricians and ,gynecologists relating to maternal care and infant care with respect to neonatal abstinence syndrome2 7ii7 pregnant women1 postpartum women1 and infants1 particularly the concurrent treatment1 as appropriate1 and comprehensive case management of pregnant women1 postpartum women and infants1 enrolled under the ,state plan 7or a waiver of such plan72 7iii7 adolescents and young adults between the ages of #ab and #ba enrolled under the ,state plan 7or a waiver of such plan72 or 7iv7 ,american ,indian and ,alaska ,native individuals enrolled under the ,state plan 7or a waiver of such plan74 7#c7 ,planning grants 7,a7 ,in general ,the ,secretary shall1 with respect to the first #ah-month period of the demonstration project conducted under paragraph 7#a71 award planning grants to at least #aj ,states selected in accordance with subparagraph 7,b7 for purposes of preparing an application described in paragraph 7#d77;,c7 and carrying out the activities described in subparagraph 7,c74 7,b7 ,selection ,in selecting ,states for purposes of this paragraph1 the ,secretary shall-- 7i7 select ,states that have a ,state plan 7or waiver of the ,state plan7 approved under this title2 7ii7 select ,states in a manner that ensures geographic diversity2 and 7iii7 give preference to ,states with a prevalence of substance use disorders 7in particular opioid use disorders7 that is comparable to or higher than the national average prevalence1 as measured by aggregate per capita drug overdoses1 or any other measure that the ,secretary deems appropriate4 7,c7 ,activities described ,activities described in this subparagraph are1 with respect to a ,state1 each of the following3 7i7 ,activities that support the development of an initial assessment of the behavioral health treatment needs of the ,state to determine the extent to which providers are needed 7including the types of such providers and geographic area of need7 to improve the network of providers that treat substance use disorders under the ,state plan 7or waiver71 including the following3 7,i7 ,an estimate of the number of individuals enrolled under the ,state plan 7or a waiver of such plan7 who have a substance use disorder4 7,,ii7 ,information on the capacity of providers to provide substance use disorder treatment or recovery services to individuals enrolled under the ,state plan 7or waiver71 including information on providers who provide such services and their participation under the ,state plan 7or waiver74 7,,iii7 ,information on the gap in substance use disorder treatment or recovery services under the ,state plan 7or waiver7 based on the information described in subclauses 7,i7 and 7,,ii74 7,,iv7 ,projections regarding the extent to which the ,state participating under the demonstration project would increase the number of providers offering substance use disorder treatment or recovery services under the ,state plan 7or waiver7 during the period of the demonstration project4 7ii7 ,activities that1 taking into account the results of the assessment described in clause 7i71 support the development of ,state infrastructure to1 with respect to the provision of substance use disorder treatment or recovery services under the ,state plan 7or a waiver of such plan71 recruit prospective providers and provide training and technical assistance to such providers4 7,d7 ,funding ,for purposes of subparagraph 7,a71 there is appropriated1 out of any funds in the ,treasury not otherwise appropriated1 #ej1jjj1jjj1 to remain available until expended4 7#d7 ,post-planning ,states 7,a7 ,in general ,the ,secretary shall1 with respect to the remaining #cf-month period of the demonstration project conducted under paragraph 7#a71 select not more than #e ,states in accordance with subparagraph 7,b7 for purposes of carrying out the activities described in paragraph 7#b7 and receiving payments in accordance with paragraph 7#e74 7,b7 ,selection ,in selecting ,states for purposes of this paragraph1 the ,secretary shall-- 7i7 select ,states that received a planning grant under paragraph 7#c72 7ii7 select ,states that submit to the ,secretary an application in accordance with the requirements in subparagraph 7,c71 taking into consideration the quality of each such application2 7iii7 select ,states in a manner that ensures geographic diversity2 and 7iv7 give preference to ,states with a prevalence of substance use disorders 7in particular opioid use disorders7 that is comparable to or higher than the national average prevalence1 as measured by aggregate per capita drug overdoses1 or any other measure that the ,secretary deems appropriate4 7,c7 ,applications 7i7 ,in general ,a ,state seeking to be selected for purposes of this paragraph shall submit to the ,secretary1 at such time and in such form and manner as the ,secretary requires1 an application that includes such information1 provisions1 and assurances1 as the ,secretary may require1 in addition to the following3 7,i7 ,a proposed process for carrying out the ongoing assessment described in paragraph 7#b77;,a71 taking into account the results of the initial assessment described in paragraph 7#c77;,c77i74 7,,ii7 ,a review of reimbursement methodologies and other policies related to substance use disorder treatment or recovery services under the ,state plan 7or waiver7 that may create barriers to increasing the number of providers delivering such services4 7,,iii7 ,the development of a plan1 taking into account activities carried out under paragraph 7#c77;,c77ii71 that will result in long-term and sustainable provider networks under the ,state plan 7or waiver7 that will offer a continuum of care for substance use disorders4 ,such plan shall include the following3 7aa7 ,specific activities to increase the number of providers 7including providers that specialize in providing substance use disorder treatment or recovery services1 hospitals1 health care systems1 ,federally qualified health centers1 and1 as applicable1 certified community behavioral health clinics7 that offer substance use disorder treatment1 recovery1 or support services1 including short-term detoxification services1 outpatient substance use disorder services1 and evidence-based peer recovery services4 7bb7 ,strategies that will incentivize providers described in subparagraphs 7,c7 and 7,d7 of paragraph 7#b7 to obtain the necessary training1 education1 and support to deliver substance use disorder treatment or recovery services in the ,state4 7cc7 ,milestones and timeliness for implementing activities set forth in the plan4 7dd7 ,specific measurable targets for increasing the substance use disorder treatment and recovery provider network under the ,state plan 7or a waiver of such plan74 7,,iv7 ,a proposed process for reporting the information required under paragraph 7#f77;,a71 including information to assess the effectiveness of the efforts of the ,state to expand the capacity of providers to deliver substance use disorder treatment or recovery services during the period of the demonstration project under this subsection4 7,v7 ,the expected financial impact of the demonstration project under this subsection on the ,state4 7,,vi7 ,a description of all funding sources available to the ,state to provide substance use disorder treatment or recovery services in the ,state4 7,,vii7 ,a preliminary plan for how the ,state will sustain any increase in the capacity of providers to deliver substance use disorder treatment or recovery services resulting from the demonstration project under this subsection after the termination of such demonstration project4 7,,viii7 ,a description of how the ,state will coordinate the goals of the demonstration project with any waiver granted 7or submitted by the ,state and pending7 pursuant to section #aaae for the delivery of substance use services under the ,state plan1 as applicable4 7ii7 ,consultation ,in completing an application under clause 7i71 a ,state shall consult with relevant stakeholders1 including ,medicaid managed care plans1 health care providers1 and ,medicaid beneficiary advocates1 and include in such application a description of such consultation4 7#e7 ,payment 7,a7 ,in general ,for each quarter occurring during the period for which the demonstration project is conducted 7after the first #ah months of such period71 the ,secretary shall pay under this subsection1 subject to subparagraph 7,c71 to each ,state selected under paragraph 7#d7 an amount equal to #hj percent of so much of the qualified sums expended during such quarter4 7,b7 ,qualified sums defined ,for purposes of subparagraph 7,a71 the term qualified sums means1 with respect to a ,state and a quarter1 the amount equal to the amount 7if any7 by which the sums expended by the ,state during such quarter attributable to substance use treatment or recovery services furnished by providers participating under the ,state plan 7or a waiver of such plan7 exceeds #a_/d of such sums expended by the ,state during fiscal year #bjah attributable to substance use treatment or recovery services4 7,c7 ,non-duplication of payment ,in the case that payment is made under subparagraph 7,a7 with respect to expenditures for substance use treatment or recovery services furnished by providers participating under the ,state plan 7or a waiver of such plan71 payment may not also be made under subsection 7a7 with respect to expenditures for the same services so furnished4 7#f7 ,reports 7,a7 ,state reports ,a ,state receiving payments under paragraph 7#e7 shall1 for the period of the demonstration project under this subsection1 submit to the ,secretary a quarterly report1 with respect to expenditures for substance use treatment or recovery services for which payment is made to the ,state under this subsection1 on the following3 7i7 ,the specific activities with respect to which payment under this subsection was provided4 7ii7 ,the number of providers that delivered substance use disorder treatment or recovery services in the ,state under the demonstration project compared to the estimated number of providers that would have otherwise delivered such services in the absence of such demonstration project4 7iii7 ,the number of individuals enrolled under the ,state plan 7or a waiver of such plan7 who received substance use disorder treatment or recovery services under the demonstration project compared to the estimated number of such individuals who would have otherwise received such services in the absence of such demonstration project4 7iv7 ,other matters as determined by the ,secretary4 7,b7 ,,cms reports 7i7 ,initial report ,not later than ,october #a1 #bjbj1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall1 in consultation with the ,director of the ,agency for ,healthcare ,research and ,quality and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 submit to ,congress an initial report on-- 7,i7 the ,states awarded planning grants under paragraph 7#c72 7,,ii7 the criteria used in such selection2 and 7,,iii7 the activities carried out by such ,states under such planning grants4 7ii7 ,interim report ,not later than ,october #a1 #bjbb1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall1 in consultation with the ,director of the ,agency for ,healthcare ,research and ,quality and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 submit to ,congress an interim report-- 7,i7 on activities carried out under the demonstration project under this subsection2 7,,ii7 on the extent to which ,states selected under paragraph 7#d7 have achieved the stated goals submitted in their applications under subparagraph 7,c7 of such paragraph2 7,,iii7 with a description of the strengths and limitations of such demonstration project2 and 7,,iv7 with a plan for the sustainability of such project4 7iii7 ,final report ,not later than ,october #a1 #bjbd1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall1 in consultation with the ,director of the ,agency for ,healthcare ,research and ,quality and the ,assistant ,secretary for ,mental ,health and ,substance ,use1 submit to ,congress a final report-- 7,i7 providing updates on the matters reported in the interim report under clause 7ii72 7,,ii7 including a description of any changes made with respect to the demonstration project under this subsection after the submission of such interim report2 and 7,,iii7 evaluating such demonstration project4 7,c7 ,,ahrq report ,not later than three years after the date of the enactment of this subsection1 the ,director of the ,agency for ,healthcare ,research and ,quality1 on consultation with the ,administrator of the ,centers for ,medicare ,medicaid ,services1 shall submit to ,congress a summary on the experiences of ,states awarded planning grants under paragraph 7#c7 and ,states selected under paragraph 7#d74 7#g7 ,data sharing and best practices ,during the period of the demonstration project under this subsection1 the ,secretary shall1 in collaboration with ,states selected under paragraph 7#d71 facilitate data sharing and the development of best practices between such ,states and ,states that were not so selected4 7#h7 ,,cms funding ,there is appropriated1 out of any funds in the ,treasury not otherwise appropriated1 #e1jjj1jjj to the ,centers for ,medicare ,medicaid ,services for purposes of implementing this subsection4 ,such amount shall remain available until expended4 4 #ajd4 ,drug management program for at-risk beneficiaries 7a7 ,in general ,title ,,xix of the ,social ,security ,act is amended by inserting after section #aibg 7#db ,u4,s4,c4 #acifr-#h7 the following new section3 #aibg;,a4 ,drug management program for at-risk beneficiaries 7a7 ,in general ,beginning ,january #a1 #bjbj1 a ,state shall operate a qualified drug management program under which a ,state may enroll certain at-risk beneficiaries identified by the ,state under the program4 7b7 ,qualified drug management program ,for purposes of this section1 the term qualified drug management program means1 with respect to a ,state1 a program carried out by the ,state 7including through a contract with a pharmacy benefit manager7 that provides at least for the following3 7#a7 ,identification of at-risk individuals ,under the program1 the ,state identifies1 in accordance with subsection 7c71 individuals enrolled under the ,state plan 7or waiver of the ,state plan7 who are at-risk beneficiaries4 7#b7 ,elements of program 7,a7 ,in general ,under the program1 the ,state1 with respect to each individual identified under paragraph 7#a7 and enrolled under the program under paragraph 7#e7-- 7i7 subject to subparagraphs 7,b7 and 7,c71 selects at least one1 but not more than three1 health care providers and at least one1 but not more than three1 pharmacies for each such individual for purposes of clause 7ii71 in accordance with a selection process that takes into account reasonable factors such as the individual's previous utilization of items and services from health care providers and pharmacies1 geographic proximity of the individual to such health care providers and pharmacies1 access of the individual to health care1 reasonable travel time1 information regarding housing status1 and any known preference of the individual for a certain health care provider or pharmacy2 and 7ii7 requires that any controlled substance furnished to such individual during the period for which such individual is enrolled under the program be prescribed by a health care provider selected under clause 7i7 for such individual and dispensed by a pharmacy selected under clause 7i7 for such individual in order for such controlled substance to be covered under the ,state plan 7or waiver74 7,b7 ,beneficiary preference ,in the case of an individual receiving a notice under paragraph 7#c77;,a7 of being identified as potentially being an at-risk beneficiary described in such paragraph1 such individual may submit1 during the #cj-;day period following receipt of such notice1 preferences for which health care providers and pharmacies the individual would prefer the ,state to select under subparagraph 7,a74 ,the ,state shall select or change the selection of health care providers and pharmacies under subparagraph 7,a7 for the individuals based on such preferences1 except that in the case that ,state determines that such selection 7or change of selection7 of a health care provider or pharmacy under subparagraph 7,a7 is contributing or would contribute to prescription drug abuse or drug diversion by the individual1 the ,state may select or change the selection of health care provider or pharmacy for the individual without regard to the preferences of the individual described in this subparagraph4 ,if the ,state selects or changes the selection pursuant to the preceding sentence without regard to the preferences of the individual1 the ,state shall provide the individual with at least #cj days written notice of the selection or change of selection and a rationale for the selection or change4 7,c7 ,treatment of pharmacy with multiple locations ,for purposes of subparagraph 7,a77i71 in the case of a pharmacy that has multiple locations that share real-time electronic prescription data1 all such locations of the pharmacy shall collectively be treated as one pharmacy4 7,d7 ,treatment of existing ,,ffs drug management programs ,in the case of a patient review and restriction program 7as identified in the annual report submitted to the ,secretary under section #aibg7;g77#c77;,d77 operated by a ,state pursuant to section #aiae7;a77#b7 before the date of the enactment of this section1 such program shall be treated as a qualified drug management program4 7,e7 ,reasonable access ,the program shall ensure1 including through waiver of elements of the program 7including under subparagraph 7,a77ii771 reasonable access to health care 7including access to health care providers and pharmacies with respect to prescription drugs described in subparagraph 7,a77 in the case of individuals with multiple residences1 in the case of natural disasters and similar situations1 and in the case of the provision of emergency services 7as defined for purposes of section #ahfj;,d-#d7;c77#e77;,d77ii77,,ii774 7#c7 ,notification to identified individuals ,under the program1 the ,state provides each individual who is identified under paragraph 7#a71 prior to enrolling such individual under the program1 at least one notification of each of the following3 7,a7 ,notice that the ,state has identified the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance4 7,b7 ,the name1 address1 and contact information of each health care provider and pharmacy that may be selected for the individual under paragraph 7#b77;,a74 7,c7 ,information describing all ,state and ,federal public health resources that are designed to address such abuse or misuse to which the individual has access1 including mental health services1 substance use disorder and recovery services1 and other counseling services4 7,d7 ,notice of1 and information about1 the right of the individual to-- 7i7 submit preferences of the individual for health care providers and pharmacies to be selected under paragraph 7#b77;,a71 including as described in paragraph 7#b77;,b72 7ii7 appeal under paragraph 7#d7-- 7,i7 such identification described in subparagraph 7,a72 and 7,,ii7 the selection of health care providers and pharmacies under paragraph 7#b77;,a74 7,e7 ,an explanation of the meaning and consequences of the identification of the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance1 including an explanation of the program4 7,f7 ,information1 including a contact list and clear instructions1 that explain how the individual can contact the appropriate entities administering the program in order to submit preferences described in paragraph 7#b77;,b7 and any other communications relating to the program4 7#d7 ,appeals process ,under the program1 the ,state provides for an appeals process under which1 with respect to an individual identified under paragraph 7#a7-- 7,a7 such individual may appeal-- 7i7 such identification2 and 7ii7 the selection of a health care provider or pharmacy under paragraph 7#b77;,a72 7,b7 in the case of an appeal described in subparagraph 7,a77ii71 the ,state shall accommodate the health care provider or pharmacy preferred by the individual for selection for purposes of paragraph 7#b77;,a71 unless the ,state determines that a change to the selection of health care provider or pharmacy under such paragraph is contributing or would contribute to prescription drug abuse or drug diversion by the individual2 7,c7 such individual is provided a period of not less than #cj days following the date of receipt of the notice described in paragraph 7#c7 to submit such appeal2 and 7,d7 the ,state must make a determination with respect to an appeal described in subparagraph 7,a71 and notify the individual of such determination1 prior to enrollment of such individual in the program4 7#e7 ,enrollment ,under the program1 the ,state initially enrolls individuals who are identified under paragraph 7#a7 in the program for a #ab-month period-- 7,a7 in the case of such an individual who does not submit an appeal under paragraph 7#d7 within the period applied by the ,state pursuant to subparagraph 7,c7 of such paragraph1 beginning on the day after the last day of such period2 and 7,b7 in the case of such an individual who does submit an appeal under paragraph 7#d7 within the period applied by the ,state pursuant to subparagraph 7,c7 of such paragraph but such appeal is denied1 beginning not later than #cj days after the date of such denial4 7#f7 ,notification of health care providers and pharmacies ,under the program1 the ,state provides to each health care provider and pharmacy selected for an individual under paragraph 7#b7-- 7,a7 notification that the individual is an at-risk beneficiary enrolled under the program and that the provider or pharmacy has been selected for the individual under paragraph 7#b72 7,b7 information on such program and the role of being so selected2 and 7,c7 a process through which the provider or pharmacy can submit a concern or complaint with respect to being so selected4 7#g7 ,continuation of enrollment ,under the program1 the ,state1 with respect to an individual enrolled under the program1 provides for a process to-- 7,a7 not later than #cj days before the end of the #ab-month period for which the individual is so enrolled pursuant to paragraph 7#e7-- 7i7 assess1 in accordance with publicly available evidence-based guidelines1 whether or not such individual should continue to be enrolled under the program2 and 7ii7 notify such individual of the results of the assessment under clause 7i72 7,b7 continue1 subject to subparagraph 7,c71 enrollment of such individual if such assessment recommends such continuation2 and 7,c7 appeal the continuation of enrollment in accordance with the appeals process described in paragraph 7#d74 7c7 ,at-,risk beneficiary 7#a7 ,identification ,for purposes of this section1 a ,state shall identify an individual enrolled under the ,state plan 7or waiver of the ,state plan7 as an at-risk beneficiary if the individual is not an exempted individual described in paragraph 7#b7 and-- 7,a7 is identified as such an at-risk beneficiary through the use of publicly available evidence-based guidelines that indicate misuse or abuse of a controlled substance2 or 7,b7 the ,state received notification from a ,,pdp sponsor or ,medicare ,advantage organization that such individual was identified as being an at-risk beneficiary for prescription drug abuse for enrollment in a drug management program established by the sponsor or organization pursuant to section #ahfj;,d-#d7;c77#e7 and such identification has not been terminated under subparagraph 7,f7 of such section4 7#b7 ,exempted individual described ,for purposes of paragraph 7#a71 an exempted individual described in this paragraph is an individual who-- 7,a7 is receiving-- 7i7 hospice or palliative care2 or 7ii7 treatment for cancer2 7,b7 is a resident of a long-term care facility1 of a facility described in section #aije7;d71 or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy2 or 7,c7 the ,state elects to treat as an exempted individual for purposes of paragraph 7#a74 7d7 ,application of privacy rules clarification ,the ,secretary shall clarify privacy requirements1 including requirements under the regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 related to the sharing of data under subsection 7b77#f7 in the same manner as the ,secretary is required under subparagraph 7,j7 of section #ahfj;,d-#d7;c77#e7 to clarify privacy requirements related to the sharing of data described in such subparagraph4 7e7 ,reports 7#a7 ,annual reports ,a ,state operating a qualified drug management program shall include in the annual report submitted to the ,secretary under section #aibg7;g77#c77;,d71 beginning with such reports submitted for #bjba1 the following information3 7,a7 ,the number of individuals enrolled under the ,state plan 7or waiver of the ,state plan7 who are enrolled under the program and the percentage of individuals enrolled under the ,state plan 7or waiver7 who are enrolled under such program4 7,b7 ,the number of prescriptions for controlled substances that were dispensed per month during each such year per individual enrolled under the program1 including the daily morphine milligram equivalents and the quantity prescribed for each such prescription4 7,c7 ,the number of pharmacies filling prescriptions for controlled substances for individuals enrolled under such program4 7,d7 ,the number of health care providers writing prescriptions for controlled substances 7other than prescriptions for a refill7 for individuals enrolled under such program4 7,e7 ,any other data that the ,secretary may require4 7,f7 ,any report submitted by a managed care entity under subsection 7f77#a77;,b7 with respect to the year involved4 ,for each such report for a year after #bjba1 the information described in this paragraph shall be provided in a manner that compares such information with respect to the prior calendar year to such information with respect to the second prior calendar year4 7#b7 ,,macpac reports and review ,not later than two years after the date of the enactment of this section1 the ,medicaid and ,,chip ,payment and ,access ,commission 7in this section referred to as ,,macpac71 in consultation with the ,national ,association of ,medicaid ,directors1 pharmacy benefit managers1 managed care organizations1 health care providers 7including pharmacists71 beneficiary advocates1 and other stakeholders1 shall publish a report that includes-- 7,a7 best practices for operating drug management programs1 based on a review of a representative sample of ,states administering such a program2 7,b7 a summary of the experience of the appeals process under drug management programs operated by several ,states1 such as the frequency at which individuals appealed the identification of being an at-risk individual1 the frequency at which individuals appealed the selection of a health care provider or pharmacy under such a program1 the timeframes for such appeals1 a summary of the reasons for such appeals1 and the design of such appeals processes2 7,c7 a summary of trends and the effectiveness of qualified drug management programs operated under this section2 and 7,d7 recommendations to ,states on how improvements can be made with respect to the operation of such programs4 ,in reporting on ,state practices1 the ,,macpac shall consider how such programs have been implemented in rural areas1 under fee-for-service as well as managed care arrangements1 and the extent to which such programs have resulted in increased efficiencies to such ,states or to the ,federal ,government under this title4 7#c7 ,report on plan for coordinated care ,not later than ,january #a1 #bjba1 each ,state operating a qualified drug management program shall submit to the ,administrator of the ,centers for ,medicare ,medicaid ,services a report on how such ,state plans to provide coordinated care for individuals enrolled under the ,state plan 7or waiver of the ,state plan7 and-- 7,a7 who are enrolled under the program2 or 7,b7 who are enrolled with a managed care entity and enrolled under such a qualified drug management program operated by such entity4 7f7 ,applicability to managed care entities 7#a7 ,in general ,with respect to any contract that a ,state enters into on or after ,january #a1 #bjbj1 with a managed care entity 7as defined in section #aicb7;a77#a77;,b77 pursuant to section #aijc7m71 the ,state shall1 as a condition of the contract1 require the managed care entity-- 7,a7 to operate a qualified drug management program 7as defined in subsection 7b77 for at-risk beneficiaries who are enrolled with such entity and identified by the managed care entity by means of application of paragraph 7#b72 7,b7 to submit to the ,state an annual report on the matters described in subparagraphs 7,a7 through 7,e7 of subsection 7e77#a72 and 7,c7 to submit to the ,state a list 7and as necessary update such list7 of individuals enrolled with such entity under the qualified drug management program operated by such entity under subparagraph 7,a7 for purposes of allowing ,state plans for which medical assistance is paid on a fee-for-service basis to have access to such information4 7#b7 ,application ,for purposes of applying1 with respect to a managed care entity-- 7,a7 under paragraph 7#a77;,a7-- 7i7 the definition of the term qualified drug management program under subsection 7b71 other than paragraph 7#b77;,d7 of such subsection2 and 7ii7 the provisions of paragraphs 7#a7 and 7#b7 of subsection 7c72 and 7,b7 under paragraph 7#a77;,b71 the report requirements described in subparagraphs 7,a7 through 7,e7 of subsection 7e77#a72 each reference in such subsection 7b7 and paragraphs of subsection 7c7 to a ,state or the ,state 7other than to a ,state plan or the ,state plan7 shall be deemed a reference to the managed care entity1 each reference under such subsection1 paragraphs1 or subparagraphs to individuals enrolled under the ,state plan 7or waiver of the ,state plan7 shall be deemed a reference to individuals enrolled with such entity1 and each reference under such subsection1 paragraphs1 or subparagraphs to individuals enrolled under the qualified drug management program operated by the ,state shall be deemed a reference to individuals enrolled under the qualified drug management program operated by the managed care entity4 7g7 ,controlled substance defined ,for purposes of this section1 the term controlled substance means a drug that is included in schedule ,,ii1 ,,iii1 or ,,iv of section #bjb7;c7 of the ,controlled ,substances ,act1 or any combination thereof1 as specified by the ,state4 4 7b7 ,guidance on at-,risk population transitioning between ,medicaid ,,ffs and managed care ,not later than ,october #a1 #bjai1 the ,secretary of ,health and ,human ,services shall issue guidance for ,state ,medicaid programs1 with respect to individuals who are enrolled under a ,state plan 7or waiver of such plan7 under title ,,xix of the ,social ,security ,act and under a drug management program1 for purposes of providing best practices-- 7#a7 for transitioning1 as applicable1 such individuals from fee-for-service ,medicaid 7and such a program operated by the ,state7 to receiving medical assistance under such title through a managed care entity 7as defined in section #aicb7;a77#a77;,b7 of the ,social ,security ,act7 with a contract that with the ,state pursuant to section #aijc7m7 of such ,act 7and such a program operated by such entity72 and 7#b7 for transitioning1 as applicable1 such individuals from receiving medical assistance under such title through a managed care entity 7as defined in section #aicb7;a77#a77;,b7 of the ,social ,security ,act7 with a contract that with the ,state pursuant to section #aijc7m7 of such ,act 7and such a program operated by such entity7 to fee-for-service ,medicaid 7and such a program operated by the ,state74 7c7 ,guidance on at-,risk population transitioning to ,medicare 7#a7 ,in general ,not later than ,january #a1 #bjbj1 the ,secretary of ,health and ,human ,services1 after consultation with the ,federal ,coordinated ,health ,care ,office established under section #bfjb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #acae;b71 shall issue guidance for ,state ,medicaid programs1 with respect to transitioning individuals1 providing for-- 7,a7 notification to be submitted by the ,state to the ,centers for ,medicare ,medicaid ,services and such individuals of the status of such individuals as transitioning individuals2 7,b7 notification to such individuals about enrollment under a prescription drug plan under part ,d of such title or under a ,,ma-,,pd plan under part ,c of such title2 7,c7 best practices for transitioning such individuals to such a plan2 and 7,d7 best practices for coordination between the qualified drug management program 7as described in section #aibg;,a7b7 of the ,social ,security ,act1 as added by subsection 7a77 carried out by the ,state and a drug management program carried out under such a plan pursuant to section #ahfj;,d-#d7;c77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77#e774 7#b7 ,transitioning individuals ,for purposes of paragraph 7#a71 a transitioning individual is an individual who1 with respect to a month-- 7,a7 is enrolled under the ,state plan 7or waiver of the ,state plan7 and under the qualified drug management program 7as described in section #aibg;,a7b7 of the ,social ,security ,act1 as added by subsection 7a77 carried out by the ,state2 and 7,b7 is expected to become eligible for the ,medicare program under title ,,xviii of such ,act during the subsequent #ab-month period4 #aje4 ,medicaid drug review and utilization 7a7 ,medicaid drug utilization review 7#a7 ,state plan requirement ,section #aijb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a771 as amended by section #aja1 is further amended-- 7,a7 in paragraph 7#hc71 at the end1 by striking and2 7,b7 in paragraph 7#hd71 at the end1 by striking the period and inserting 2 and2 and 7,c7 by inserting after paragraph 7#hd7 the following new paragraph3 7#he7 provide that the ,state is in compliance with the drug review and utilization requirements under subsection 7oo77#a74 4 7#b7 ,drug review and utilization requirements ,section #aijb of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a71 as amended by section #aja1 is further amended by adding at the end the following new subsection3 7oo7 ,drug review and utilization requirements 7#a7 ,in general ,for purposes of subsection 7a77#he71 the drug review and utilization requirements under this subsection are1 subject to paragraph 7#c7 and beginning ,october #a1 #bjai1 the following3 7,a7 ,claims review limitations 7i7 ,in general ,the ,state has in place-- 7,i7 safety edits 7as specified by the ,state7 for subsequent fills for opioids and a claims review automated process 7as designed and implemented by the ,state7 that indicates when an individual enrolled under the ,state plan 7or under a waiver of the ,state plan7 is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the ,state2 7,,ii7 safety edits 7as specified by the ,state7 on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the ,state plan 7or under a waiver of the ,state plan7 for treatment of chronic pain and a claims review automated process 7as designed and implemented by the ,state7 that indicates when an individual enrolled under the plan 7or waiver7 is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the ,state2 and 7,,iii7 a claims review automated process 7as designed and implemented by the ,state7 that monitors when an individual enrolled under the ,state plan 7or under a waiver of the ,state plan7 is concurrently prescribed opioids and-- 7aa7 benzodiazepines2 or 7bb7 antipsychotics4 7ii7 ,managed care entities ,the ,state requires each managed care entity 7as defined in section #aicb7;a77#a77;,b77 with respect to which the ,state has a contract under section #aijc7m7 or under section #aije7t77#c7 to have in place1 subject to paragraph 7#c71 with respect to individuals who are eligible for medical assistance under the ,state plan 7or under a waiver of the ,state plan7 and who are enrolled with the entity1 the limitations described in subclauses 7,i7 and 7,,ii7 of clause 7i7 and a claims review automated process described in subclause 7,,iii7 of such clause4 7iii7 ,rules of construction ,nothing in this subparagraph may be construed as prohibiting a ,state or managed care entity from designing and implementing a claims review automated process under this subparagraph that provides for prospective or retrospective reviews of claims4 ,nothing in this subparagraph shall be understood as prohibiting the exercise of clinical judgment from a provider enrolled as a participating provider in a ,state plan 7or waiver of the ,state plan7 or contracting with a managed care entity regarding the best items and services for an individual enrolled under such ,state plan 7or waiver74 7,b7 ,program to monitor antipsychotic medications by children ,the ,state has in place a program 7as designed and implemented by the ,state7 to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the ,state plan 7or under a waiver of the ,state plan7 and submits annually to the ,secretary such information as the ,secretary may require on activities carried out under such program for individuals not more than the age of #ah years generally and children in foster care specifically4 7,c7 ,fraud and abuse identification ,the ,state has in place a process 7as designed and implemented by the ,state7 that identifies potential fraud or abuse of controlled substances by individuals enrolled under the ,state plan 7or under a waiver of the ,state plan71 health care providers prescribing drugs to individuals so enrolled1 and pharmacies dispensing drugs to individuals so enrolled4 7,d7 ,reports ,the ,state shall include in the annual report submitted to the ,secretary under section #aibg7;g77#c77;,d7 information on the limitations1 requirement1 program1 and processes applied by the ,state under subparagraphs 7,a7 through 7,c7 in accordance with such manner and time as specified by the ,secretary4 7,e7 ,clarification ,nothing shall prevent a ,state from satisfying the requirement-- 7i7 described in subparagraph 7,a7 by having safety edits or a claims review automated process described in such subparagraph that was in place before ,october #a1 #bjai2 7ii7 described in subparagraph 7,b7 by having a program described in such subparagraph that was in place before such date2 or 7iii7 described in subparagraph 7,c7 by having a process described in such subparagraph that was in place before such date4 7#b7 ,annual report by ,secretary ,for each fiscal year beginning with fiscal year #bjbj1 the ,secretary shall submit to ,congress a report on the most recent information submitted by ,states under paragraph 7#a77;,d74 7#c7 ,exceptions 7,a7 ,certain individuals exempted ,the drug review and utilization requirements under this subsection shall not apply with respect to an individual who-- 7i7 is receiving-- 7,i7 hospice or palliative care2 or 7,,ii7 treatment for cancer2 7ii7 is a resident of a long-term care facility1 of a facility described in section #aije7;d71 or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy2 or 7iii7 the ,state elects to treat as exempted from such requirements4 7,b7 ,exception relating to ensuring access ,in order to ensure reasonable access to health care1 the ,secretary shall waive the drug review and utilization requirements under this subsection1 with respect to a ,state1 in the case of natural disasters and similar situations1 and in the case of the provision of emergency services 7as defined for purposes of section #ahfj;,d-#d7;c77#e77;,d77ii77,,ii774 4 7#c7 ,managed care entities ,section #aicb of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7 is amended by adding at the end the following new subsection3 7i7 ,drug utilization review activities and requirements ,beginning not later than ,october #a1 #bjai1 each contract under a ,state plan with a managed care entity 7other than a primary care case manager7 under section #aijc7m7 shall provide that the entity is in compliance with the applicable provisions of section #dch4c7s77#b7 of title #db of the ,code of ,federal ,regulations1 section #dhc4c7s77#d77 of such title1 and section #dhc4c7s77#e7 of such title1 as such provisions were in effect on ,march #ca1 #bjah4 4 7b7 ,identifying and addressing inappropriate prescribing and billing practices under ,medicaid 7#a7 ,in general ,section #aibg7;g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;g77 is amended-- 7,a7 in paragraph 7#a77;,a7-- 7i7 by striking of section #aijc7;i77#aj77;,b7 and inserting of section #aijb7;a77#ed72 7ii7 by striking 1 by not later than ,january #a1 #aiic12 7iii7 by inserting after gross overuse1 the following3 excessive utilization12 and 7iv7 by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care1 or prescribing or billing practices that indicate abuse or excessive utilization2 and 7,b7 in paragraph 7#b77;,b7-- 7i7 by inserting after gross overuse1 the following3 excessive utilization12 and 7ii7 by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care1 or prescribing or billing practices that indicate abuse or excessive utilization4 7#b7 ,effective date ,the amendments made by paragraph 7#a7 shall take effect with respect to retrospective drug use reviews conducted on or after ,october #a1 #bjbj4 #ajf4 ,guidance to improve care for infants with neonatal abstinence syndrome and their mothers2 ,,gao study on gaps in ,medicaid coverage for pregnant and postpartum women with substance use disorder 7a7 ,guidance ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue guidance to improve care for infants with neonatal abstinence syndrome and their families4 ,such guidance shall include-- 7#a7 the types of services1 including post-discharge services and parenting supports1 for families of babies with neonatal abstinence syndrome that ,states may cover under the ,medicaid program under title ,,xix of the ,social ,security ,act2 7#b7 best practices from ,states with respect to innovative or evidenced-based payment models that focus on prevention1 screening1 treatment1 plans of safe care1 and post-discharge services for mothers and fathers with substance use disorders and babies with neonatal abstinence syndrome that improve care and clinical outcomes2 7#c7 recommendations for ,states on available financing options under the ,medicaid program under title ,,xix of such ,act and under the ,children's ,health ,insurance ,program under title ,,xxi of such ,act for ,children's ,health ,insurance ,program ,health ,services ,initiative funds for parents with substance use disorders1 infants with neonatal abstinence syndrome1 and home visiting services2 and 7#d7 guidance and technical assistance to ,state ,medicaid agencies regarding additional flexibilities and incentives related to screening1 prevention1 and post-discharge services1 including parenting supports4 7b7 ,,gao study ,not later than one year after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study1 and submit to ,congress a report1 addressing gaps in coverage for pregnant women with substance use disorder under the ,medicaid program under title ,,xix of the ,social ,security ,act1 and gaps in coverage for postpartum women with substance use disorder who had coverage during their pregnancy under the ,medicaid program under such title4 #ajg4 ,medicaid health homes for opioid-use-disorder ,medicaid enrollees 7a7 ,extension of enhanced ,,fmap for certain health homes for individuals with substance use disorders ,section #aide of the ,social ,security ,act 7#db ,u4,s4,c4 #acifw-#d7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#a71 by inserting subject to paragraph 7#d71 after except that12 and 7,b7 by adding at the end the following new paragraph3 7#d7 ,special rule relating to substance use disorder health homes 7,a7 ,in general ,in the case of a ,state with an ,,sud-focused ,state plan amendment approved by the ,secretary on or after ,october #a1 #bjah1 the ,secretary may1 at the request of the ,state1 extend the application of the ,federal medical assistance percentage described in paragraph 7#a7 to payments for the provision of health home services to ,,sud-eligible individuals under such ,state plan amendment1 in addition to the first #h fiscal year quarters the ,state plan amendment is in effect1 for the subsequent #b fiscal year quarters that the ,state plan amendment is in effect4 ,nothing in this section shall be construed as prohibiting a ,state with a ,state plan amendment that is approved under this section and that is not an ,,sud-focused ,state plan amendment from additionally having approved on or after such date an ,,sud-focused ,state plan amendment under this section1 including for purposes of application of this paragraph4 7,b7 ,report requirements ,in the case of a ,state with an ,,sud-focused ,state plan amendment for which the application of the ,federal medical assistance percentage has been extended under subparagraph 7,a71 such ,state shall1 at the end of the period of such ,state plan amendment1 submit to the ,secretary a report on the following1 with respect to ,,sud-eligible individuals provided health home services under such ,state plan amendment3 7i7 ,the quality of health care provided to such individuals1 with a focus on outcomes relevant to the recovery of each such individual4 7ii7 ,the access of such individuals to health care4 7iii7 ,the total expenditures of such individuals for health care4 ,for purposes of this subparagraph1 the ,secretary shall specify all applicable measures for determining quality1 access1 and expenditures4 7,c7 ,best practices ,not later than ,october #a1 #bjbj1 the ,secretary shall make publicly available on the ,internet website of the ,centers for ,medicare ,medicaid ,services best practices for designing and implementing an ,,sud-focused ,state plan amendment1 based on the experiences of ,states that have ,state plan amendments approved under this section that include ,,sud-eligible individuals4 7,d7 ,definitions ,for purposes of this paragraph3 7i7 ,,sud-eligible individuals ,the term ,,sud-eligible individual means1 with respect to a ,state1 an individual who satisfies all of the following3 7,i7 ,the individual is an eligible individual with chronic conditions4 7,,ii7 ,the individual is an individual with a substance use disorder4 7,,iii7 ,the individual has not previously received health home services under any other ,state plan amendment approved for the ,state under this section by the ,secretary4 7ii7 ,,sud-focused ,state plan amendment ,the term ,,sud-focused ,state plan amendment means a ,state plan amendment under this section that is designed to provide health home services primarily to ,,sud-eligible individuals4 4 7b7 ,requirement for ,state ,medicaid plans ,to provide coverage for medication-,assisted treatment 7#a7 ,requirement for ,state ,medicaid plans to provide coverage for medication-assisted treatment ,section #aijb7;a77#aj77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77 is amended1 in the matter preceding clause 7i71 by striking and 7#bh7 and inserting 7#bh71 and 7#bi74 7#b7 ,inclusion of medication-assisted treatment as medical assistance ,section #aije7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77 is amended-- 7,a7 in paragraph 7#bh71 by striking and at the end2 7,b7 by redesignating paragraph 7#bi7 as paragraph 7#cj72 and 7,c7 by inserting after paragraph 7#bh7 the following new paragraph3 7#bi7 subject to paragraph 7#b7 of subsection 7ee71 for the period beginning ,october #a1 #bjbj1 and ending ,september #cj1 #bjbe1 medication-assisted treatment 7as defined in paragraph 7#a7 of such subsection72 and 4 7#c7 ,medication-assisted treatment defined2 ,waivers ,section #aije of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is amended by adding at the end the following new subsection3 7ee7 ,medication-,assisted treatment 7#a7 ,definition ,for purposes of subsection 7a77#bi71 the term medication-assisted treatment-- 7,a7 means all drugs approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 including methadone1 and all biological products licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 to treat opioid use disorders2 and 7,b7 includes1 with respect to the provision of such drugs and biological products1 counseling services and behavioral therapy4 7#b7 ,exception ,the provisions of paragraph 7#bi7 of subsection 7a7 shall not apply with respect to a ,state for the period specified in such paragraph1 if before the beginning of such period the ,state certifies to the satisfaction of the ,secretary that implementing such provisions statewide for all individuals eligible to enroll in the ,state plan 7or waiver of the ,state plan7 would not be feasible by reason of a shortage of qualified providers of medication-assisted treatment1 or facilities providing such treatment1 that will contract with the ,state or a managed care entity with which the ,state has a contract under section #aijc7m7 or under section #aije7t77#c74 4 7#d7 ,effective date 7,a7 ,in general ,subject to subparagraph 7,b71 the amendments made by this subsection shall apply with respect to medical assistance provided on or after ,october #a1 #bjbj1 and before ,october #a1 #bjbe4 7,b7 ,exception for ,state legislation ,in the case of a ,state plan under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 that the ,secretary of ,health and ,human ,services determines requires ,state legislation in order for the respective plan to meet any requirement imposed by the amendments made by this subsection1 the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of the enactment of this ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of the session shall be considered to be a separate regular session of the ,state legislature4 ,,ii ,medicare ,provisions to ,address the ,opioid ,crisis #bja4 ,authority not to apply certain ,medicare telehealth requirements in the case of certain treatment of a substance use disorder or co-occurring mental health disorder ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended-- 7#a7 in paragraph 7#b77;,b77i71 by inserting and paragraph 7#g77;,e7 after ,subject to clause 7ii72 and 7#b7 by adding at the end the following new paragraphs3 7#g7 ,authority not to apply certain requirements in the case of certain treatment of substance use disorder or co-occurring mental health disorder 7,a7 ,in general ,for purposes of payment under this subsection1 in the case of telehealth services described in subparagraph 7,c7 furnished on or after ,january #a1 #bjbj1 to an eligible beneficiary 7as defined in subparagraph 7,f77 for the treatment of a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder1 the ,secretary is authorized to1 through rulemaking1 not apply any of the requirements described in subparagraph 7,b74 7,b7 ,requirements described ,for purposes of this paragraph1 the requirements described in this subparagraph are any of the following3 7i7 ,qualifications for an originating site under paragraph 7#d77;,c77ii74 7ii7 ,geographic limitations under paragraph 7#d77;,c77i74 7,c7 ,telehealth services described ,for purposes of this paragraph1 the telehealth services described in this subparagraph are services that are both telehealth services and identified by the ,secretary1 through rulemaking1 as services that are the most commonly furnished 7as defined by the ,secretary7 under this part to individuals diagnosed with a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder4 7,d7 ,clarification ,nothing in this paragraph shall be construed as limiting or otherwise affecting the authority of the ,secretary to limit or eliminate the non-application pursuant to this paragraph of any of the requirements under subparagraph 7,b74 7,e7 ,treatment of originating site facility fee ,no facility fee shall be paid under paragraph 7#b77;,b7 to an originating site with respect to a telehealth service described in subparagraph 7,b7 for which payment is made under this subsection by reason of the non-application of a requirement described in subparagraph 7,b7 pursuant to this paragraph if payment for such service would not otherwise be permitted under this subsection if such requirement were applied4 7,f7 ,eligible beneficiary defined ,for purposes of this paragraph1 the term eligible beneficiary means an individual who-- 7i7 is entitled to1 or enrolled for1 benefits under part ,a and enrolled for benefits under this part2 7ii7 has a diagnosis for a substance use disorder2 and 7iii7 meets such other criteria as the ,secretary determines appropriate4 7,g7 ,report ,not later than #e years after the date of the enactment of this paragraph1 the ,secretary shall submit to ,congress a report on the impact of any non-application under this paragraph of any of the requirements described in subparagraph 7,b7 on 7i7 the utilization of health care services related to substance use disorder1 such as behavioral health services and emergency department visits2 and 7ii7 health outcomes related to substance use disorder1 such as substance use overdose deaths4 7,h7 ,funding ,for purposes of carrying out this paragraph1 in addition to funds otherwise available1 the ,secretary shall provide for the transfer1 from the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda1 of #c1jjj1jjj to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account to remain available until expended4 7#h7 ,rule of construction ,nothing in this subsection may be construed as waiving requirements under this title to comply with applicable ,state law1 including ,state licensure requirements4 4 #bjb4 ,encouraging the use of non-opioid analgesics for the management of post-surgical pain ,section #ahcc7t77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#f77 is amended-- 7#a7 in subparagraph 7,c77i71 by inserting or1 in the case of an eligible non-opioid analgesic 7as defined in subparagraph 7,j771 during a period of #e years1 after #c years12 and 7#b7 by adding at the end the following new subparagraph3 7,j7 ,eligible non-opioid analgesic defined ,in this paragraph1 the term eligible non-opioid analgesic means a drug or biological-- 7i7 that is an analgesic that is not an opioid2 7ii7 that demonstrated substantial clinical improvement2 and 7iii7 for which payment-- 7,i7 as an outpatient hospital service under this part was not being made as of the date of the enactment of this subparagraph2 or 7,,ii7 was being made under this paragraph as of such date4 4 #bjc4 ,requiring a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the ,welcome to ,medicare initial preventive physical examination 7a7 ,in general ,section #ahfa7ww7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ww77 is amended-- 7#a7 in paragraph 7#a71 by inserting and a review of current opioid prescriptions and screening for opioid use disorder 7as defined in paragraph 7#d771 before but does not include2 and 7#b7 by adding at the end the following new paragraph3 7#d7 7,a7 ,for purposes of paragraph 7#a71 the term a review of current opioid prescriptions and screening for opioid use disorder means1 with respect to an individual-- 7i7 a review by a physician or qualified non-physician practitioner of all current prescriptions of the individual2 and 7ii7 in the case of an individual determined by the review of a physician or qualified non-physician practitioner under subparagraph 7,a7 to have a current prescription for opioids for chronic pain that has been prescribed for a minimum period of time 7as specified by the ,secretary7-- 7,i7 a review by the physician or practitioner of the potential risk factors to the individual for opioid use disorder2 7,,ii7 an evaluation by the physician or practitioner of pain of the individual2 7,,iii7 the provision of information regarding non-opioid treatment options for the treatment and management of any chronic pain of the individual2 and 7,,iv7 if determined necessary by the physician or practitioner based on the results of the review and evaluation conducted as described in this paragraph1 an appropriate referral by the physician or practitioner for additional treatment4 7,b7 ,for purposes of this paragraph1 the term qualified non-physician practitioner means a physician assistant1 nurse practitioner1 or certified clinical nurse specialist4 4 7b7 ,effective date ,the amendments made by subsection 7a7 shall apply with respect to initial preventive physical examinations furnished on or after ,january #a1 #bjbj4 #bjd4 ,modification of payment for certain outpatient surgical services 7a7 ,freeze of payment for certain services furnished in ambulatory surgical centers ,section #ahcc7;i77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77 is amended by adding at the end the following new subparagraph3 7,f7 7i7 ,with respect to a targeted procedure 7as defined in clause 7ii77 furnished during #bjbj or a subsequent year 7before #bjbd7 to an individual in an ambulatory surgical center1 the payment amount for such procedure that would otherwise be determined under the revised payment system under subparagraph 7,d71 without application of this subparagraph1 shall be equal to the payment amount for such procedure furnished in #bjaf4 7ii7 ,for purposes of clause 7i71 the term targeted procedure means a procedure to which ,healthcare ,common ,procedure ,coding ,system #fbcaj 7or1 for years beginning after #bjaf1 #fbcba71 #fbcaa 7or1 for years beginning after #bjaf1 #fbcbc71 #fbbfd1 #fddij1 #fddic1 or ,g#jbfj 7or any successor code7 applies4 7iii7 ,this subparagraph shall not be applied in a budget-neutral manner4 4 7b7 ,data collection 7#a7 ,in general ,the ,comptroller ,general shall collect data relating to the cost differential between targeted procedures 7as defined in section #ahcc7;i77#b77;,f77ii7 of the ,social ,security ,act1 as added by subsection 7a77 that are performed in a hospital operating room and such procedures that are performed in an office setting within a hospital in order to determine whether such procedures are being properly coded for claims1 based on setting1 for payment under section #ahcc7;i77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77;,d77 and to determine if further changes are needed in the classification system for covered outpatient department services 7as described in section #ahcc7t77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#b77;,a774 7#b7 ,report ,not later than #d years after the date of the enactment of this ,act1 the ,comptroller ,general shall submit a report to the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives and the ,committee on ,finance of the ,senate containing-- 7,a7 a determination of whether procedures described in paragraph 7#a7 are being properly coded for claims1 based on setting1 for payment under section #ahcc7;i77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77;,d772 and 7,b7 recommendations on any changes the ,comptroller ,general determines are needed in the classification system for covered outpatient department services 7as described in section #ahcc7t77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#b77;,a774 7c7 ,study ,not later than #c years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall conduct a study and submit to ,congress a report on the extent to which procedures described in section #ahcc7;i77#b77;,f77ii7 of the ,social ,security ,act1 as added by subsection 7a71 are effective at preventing the need for opioids for individuals furnished such procedures4 #bje4 ,requiring e-prescribing for coverage of covered part ,d controlled substances 7a7 ,in general ,section #ahfj;,d-#d7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77 is amended by adding at the end the following3 7#g7 ,requirement of e-prescribing for controlled substances 7,a7 ,in general ,subject to subparagraph 7,b71 a prescription for a covered part ,d drug under a prescription drug plan 7or under an ,,ma-,,pd plan7 for a schedule ,,ii1 ,,iii1 ,,iv1 or ,v controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph 7#b74 7,b7 ,exception for certain circumstances ,the ,secretary shall1 pursuant to rulemaking1 specify circumstances with respect to which the ,secretary may waive the requirement under subparagraph 7,a71 with respect to a covered part ,d drug1 including in the case of-- 7i7 a prescription issued when the practitioner and dispenser are the same entity2 7ii7 a prescription issued that cannot be transmitted electronically under the most recently implemented version of the ,national ,council for ,prescription ,drug ,programs ,,script ,standard2 7iii7 a prescription issued by a practitioner who has received a waiver or a renewal thereof for a specified period determined by the ,secretary1 not to exceed one year1 from the requirement to use electronic prescribing1 pursuant to a process established by regulation by the ,secretary1 due to demonstrated economic hardship1 technological limitations that are not reasonably within the control of the practitioner1 or other exceptional circumstance demonstrated by the practitioner2 7iv7 a prescription issued by a practitioner under circumstances in which1 notwithstanding the practitioner's ability to submit a prescription electronically as required by this subsection1 such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner1 and such delay would adversely impact the individual's medical condition involved2 7v7 a prescription issued by a practitioner allowing for the dispensing of a non-patient specific prescription pursuant to a standing order1 approved protocol for drug therapy1 collaborative drug management1 or comprehensive medication management1 in response to a public health emergency1 or other circumstances where the practitioner may issue a non-patient specific prescription2 7vi7 a prescription issued by a practitioner prescribing a drug under a research protocol2 7vii7 a prescription issued by a practitioner for a drug for which the ,food and ,drug ,administration requires a prescription to contain elements that are not able to be included in electronic prescribing1 such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use2 and 7viii7 a prescription issued by a practitioner for an individual who-- 7,i7 receives hospice care under this title2 or 7,,ii7 is a resident of a skilled nursing facility 7as defined in section #ahai7;a771 or a medical institution or nursing facility for which payment is made for an institutionalized individual under section #aijb7q77#a77;,b71 for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy1 as determined by the ,secretary in accordance with this paragraph4 7,c7 ,dispensing ,nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part1 ,,ma organization offering an ,,ma-,,pd plan under part ,c1 or a pharmacist to verify that a practitioner1 with respect to a prescription for a covered part ,d drug1 has a waiver 7or is otherwise exempt7 under subparagraph 7,b7 from the requirement under subparagraph 7,a74 ,nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists' ability to continue to dispense covered part ,d drugs from otherwise valid written1 oral or fax prescriptions that are consistent with laws and regulations4 ,nothing in this paragraph shall be construed as affecting the ability of the beneficiary involved to designate a particular pharmacy to dispense a prescribed drug to the extent consistent with the requirements under subsection 7b77#a7 and under this paragraph4 7,d7 ,enforcement ,the ,secretary shall1 pursuant to rulemaking1 have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph 7,a74 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall apply to coverage of drugs prescribed on or after ,january #a1 #bjba4 #bjf4 ,requiring prescription drug plan sponsors under ,medicare to establish drug management programs for at-risk beneficiaries ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is amended-- 7#a7 in paragraph 7#a71 by inserting after subparagraph 7,e7 the following new subparagraph3 7,f7 ,with respect to plan years beginning on or after ,january #a1 #bjba1 a drug management program for at-risk beneficiaries described in paragraph 7#e74 2 and 7#b7 in paragraph 7#e77;,a71 by inserting 7and for plan years beginning on or after ,january #a1 #bjba1 a ,,pdp sponsor shall7 after ,a ,,pdp sponsor may4 #bjg4 ,medicare coverage of certain services furnished by opioid treatment programs 7a7 ,coverage ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7#a7 in subparagraph 7,,ff71 by striking at the end and2 7#b7 in subparagraph 7,,gg71 by inserting at the end 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,,hh7 opioid use disorder treatment services 7as defined in subsection 7jjj774 4 7b7 ,opioid use disorder treatment services and opioid treatment program defined ,section #ahfa of the ,social ,security ,act is amended by adding at the end the following new subsection3 7jjj7 ,opioid use disorder treatment services2 opioid treatment program 7#a7 ,opioid use disorder treatment services ,the term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder1 including-- 7,a7 opioid agonist and antagonist treatment medications 7including oral1 injected1 or implanted versions7 that are approved by the ,food and ,drug ,administration under section #eje of the ,federal ,food1 ,drug and ,cosmetic ,act for use in the treatment of opioid use disorder2 7,b7 dispensing and administration of such medications1 if applicable2 7,c7 substance use counseling by a professional to the extent authorized under ,state law to furnish such services2 7,d7 individual and group therapy with a physician or psychologist 7or other mental health professional to the extent authorized under ,state law72 7,e7 toxicology testing1 and 7,f7 other items and services that the ,secretary determines are appropriate 7but in no event to include meals or transportation74 7#b7 ,opioid treatment program ,the term opioid treatment program means an entity that is opioid treatment program 7as defined in section #h4b of title #db of the ,code of ,federal ,regulations1 or any successor regulation7 that-- 7,a7 is enrolled under section #ahff7;j72 7,b7 has in effect a certification by the ,substance ,abuse and ,mental ,health ,services ,administration for such a program2 7,c7 is accredited by an accrediting body approved by the ,substance ,abuse and ,mental ,health ,services ,administration2 and 7,d7 meets such additional conditions as the ,secretary may find necessary to ensure-- 7i7 the health and safety of individuals being furnished services under such program2 and 7ii7 the effective and efficient furnishing of such services4 4 7c7 ,payment 7#a7 ,in general ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7,a7 by striking and 7,,bb7 and inserting 7,,bb72 and 7,b7 by inserting before the semicolon at the end the following 1 and 7,,cc7 with respect to opioid use disorder treatment services furnished during an episode of care1 the amount paid shall be equal to the amount payable under section #ahcd7w7 less any copayment required as specified by the ,secretary4 7#b7 ,payment determination ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7w7 ,opioid use disorder treatment services 7#a7 ,in general ,the ,secretary shall pay to an opioid treatment program 7as defined in paragraph 7#b7 of section #ahfa7;jjj77 an amount that is equal to #ajj percent of a bundled payment under this part for opioid use disorder treatment services 7as defined in paragraph 7#a7 of such section7 that are furnished by such program to an individual during an episode of care 7as defined by the ,secretary7 beginning on or after ,january #a1 #bjbj4 ,the ,secretary shall ensure1 as determined appropriate by the ,secretary1 that no duplicative payments are made under this part or part ,d for items and services furnished by an opioid treatment program4 7#b7 ,considerations ,the ,secretary may implement this subsection through one or more bundles based on the type of medication provided 7such as buprenorphine1 methadone1 naltrexone1 or a new innovative drug71 the frequency of services1 the scope of services furnished1 characteristics of the individuals furnished such services1 or other factors as the ,secretary determine appropriate4 ,in developing such bundles1 the ,secretary may consider payment rates paid to opioid treatment programs for comparable services under ,state plans under title ,,xix or under the ,,tricare program under chapter #ee of title #aj of the ,united ,states ,code4 7#c7 ,annual updates ,the ,secretary shall provide an update each year to the bundled payment amounts under this subsection4 4 7d7 ,including opioid treatment programs as ,medicare providers ,section #ahff7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7e77 is amended-- 7#a7 in paragraph 7#a71 by striking at the end and2 7#b7 in paragraph 7#b71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following new paragraph3 7#c7 opioid treatment programs 7as defined in paragraph 7#b7 of section #ahfa7;jjj771 but only with respect to the furnishing of opioid use disorder treatment services 7as defined in paragraph 7#a7 of such section74 4 ,,iii ,other ,health ,provisions to ,address the ,opioid ,crisis #cja4 ,clarifying ,,fda regulation of non-addictive pain and addiction therapies 7a7 ,public meetings ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat pain or addiction1 which may include-- 7#a7 the application of novel clinical trial designs 7consistent with section #cjba of the #bast ,century ,cures ,act 7,public ,law #aad-bee771 use of real world evidence 7consistent with section #eje;,f of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g771 and use of patient experience data 7consistent with section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c77 for the development of non-addictive medical products intended to treat pain or addiction2 and 7#b7 the application of eligibility criteria under sections #ejf and #eae;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef1 #cfj;e-#c7 for non-addictive medical products intended to treat pain or addiction4 7b7 ,guidance ,not later than one year after the public meetings are conducted under subsection 7a7 the ,secretary shall issue one or more final guidance documents1 or update existing guidance documents1 to help address challenges to developing non-addictive medical products to treat pain or addiction4 ,such guidance documents shall include information regarding-- 7#a7 how the ,food and ,drug ,administration may apply sections #ejf and #eae;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef1 #cfj;e-#c7 to non-addictive medical products intended to treat pain or addiction1 including the circumstances under which the ,secretary-- 7,a7 may apply the eligibility criteria under such sections #ejf and #eae;,b to non-opioid or non-addictive medical products intended to treat pain or addiction2 7,b7 considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need2 and 7,c7 considers pain1 pain control1 or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition2 and 7#b7 the methods by which sponsors may evaluate acute and chronic pain1 endpoints for non-addictive medical products intended to treat pain1 the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions1 taking into consideration the etiology of the underlying disease1 and the manner in which sponsors may use surrogate endpoints1 intermediate endpoints1 and real world evidence4 7c7 ,medical product defined ,in this section1 the term medical product means a drug 7as defined in section #bja7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7771 biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i7771 or device 7as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h7774 #cjb4 ,surveillance and ,testing of ,opioids to ,prevent ,fentanyl ,deaths 7a7 ,public health laboratories ,to detect fentanyl ,part ,f of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb et seq47 is amended-- 7#a7 in the heading of part ,f1 by striking and clinical laboratories and inserting 1 clinical laboratories1 and public health laboratories2 and 7#b7 by adding at the end the following new subpart3 #d ,public ,health ,laboratories #cee4 ,public health laboratories to detect fentanyl 7a7 ,in general ,the ,secretary shall establish a program to award grants to ,federal1 ,state1 and local agencies to support the establishment or operation of public health laboratories to detect fentanyl1 its analogues1 and other synthetic opioids1 as described in subsection 7b74 7b7 ,standards ,the ,secretary1 in consultation with the ,director of the ,national ,institute of ,standards and ,technology1 shall-- 7#a7 develop standards for safely and effectively handling and testing fentanyl1 its analogues1 and other synthetic opioids2 7#b7 develop fentanyl and fentanyl analog reference materials and quality control standards and protocols to calibrate instrumentation for clinical diagnostics and postmortem surveillance2 and 7#c7 include in the standards developed pursuant to paragraph 7#a7 procedures for encountering new and emerging synthetic opioid formulations and reporting those findings to other ,federal1 ,state1 and local public health laboratories4 7c7 ,laboratories ,the ,secretary shall require grantees under subsection 7a7 to-- 7#a7 follow the standards established under subsection 7b7 and be capable of providing systematic and routine laboratory testing of drugs for the purposes of obtaining and disseminating public health information to ,federal1 ,state1 and local public health officials1 laboratories1 and other entities the ,secretary deems appropriate2 7#b7 work with law enforcement agencies and public health authorities1 as feasible1 to develop real-time information on the purity and movement of fentanyl1 its analogues1 and other synthetic opioids2 7#c7 assist ,state and local law enforcement agencies in testing seized drugs when ,state and local forensic laboratories request additional assistance2 7#d7 provide early warning information and advice to ,federal1 ,state1 and local law enforcement agencies and public health authorities regarding potential significant changes in the supply of fentanyl1 its analogues1 and other synthetic opioids2 7#e7 provide biosurveillance for non-fatal exposures2 and 7#f7 provide diagnostic testing for non-fatal exposures of emergency personnel4 7d7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #ae1jjj1jjj for each of fiscal years #bjai through #bjbc4 4 7b7 ,enhanced fentanyl surveillance ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #cag,t of such ,act 7#db ,u4,s4,c4 #bdg;b-#bb7 the following new section3 #cag,u4 ,enhanced fentanyl surveillance 7a7 ,in general ,the ,director of the ,centers for ,disease ,control and ,prevention shall enhance its drug surveillance program by-- 7#a7 expanding its surveillance program to include all #ej ,states and the territories of the ,united ,states2 7#b7 increasing and accelerating the collection of data on fentanyl1 its analogues1 and other synthetic opioids and new emerging drugs of abuse1 including related overdose data from medical examiners and drug treatment admissions2 and 7#c7 utilizing available and emerging information on fentanyl1 its analogues1 and other synthetic opioids and new emerging drugs of abuse1 including information from-- 7,a7 the ,national ,drug ,early ,warning ,system2 7,b7 ,state and local public health authorities2 and 7,c7 ,federal1 ,state1 and local public health laboratories4 7b7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #aj1jjj1jjj for each of fiscal years #bjai through #bjbc4 4 7c7 ,pilot program for point-of-,use testing of illicit drugs for dangerous contaminants ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following new section3 #cii,v-#g4 ,pilot program for point-of-use testing of illicit drugs for dangerous contaminants 7a7 ,in general ,the ,secretary shall-- 7#a7 establish a pilot program through which #e ,state or local agencies conduct1 in #e ,states1 point-of-use testing of illicit drugs for dangerous contaminants2 7#b7 establish metrics to evaluate the success of the pilot program in reducing drug overdose rates2 and 7#c7 based on such metrics1 conduct an annual evaluation of the pilot program and submit an annual report to the ,congress containing the results of such evaluation4 7b7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #e1jjj1jjj for each of fiscal years #bjai through #bjbc4 4 #cjc4 ,allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders 7a7 ,conforming applicable number ,subclause 7,,ii7 of section #cjc7;g77#b77;,b77iii7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,b77iii77 is amended to read as follows3 7,,ii7 ,the applicable number is-- 7aa7 #ajj if1 not sooner than #a year after the date on which the practitioner submitted the initial notification1 the practitioner submits a second notification to the ,secretary of the need and intent of the practitioner to treat up to #ajj patients2 7bb7 #ajj if the practitioner holds additional credentialing1 as defined in section #h4b of title #db1 ,code of ,federal ,regulations 7or successor regulations72 or 7cc7 #ajj if the practitioner provides medication-assisted treatment 7,,mat7 using covered medications 7as such terms are defined in section #h4b of title #db1 ,code of ,federal ,regulations 7or successor regulations77 in a qualified practice setting 7as described in section #h4fae of title #db1 ,code of ,federal ,regulations 7or successor regulations774 4 7b7 ,eliminating any time limitation for nurse practitioners and physician assistants ,to become qualifying practitioners ,clause 7iii7 of section #cjc7;g77#b77;,g7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77 is amended-- 7#a7 in subclause 7,i71 by striking or at the end2 and 7#b7 by amending subclause 7,,ii7 to read as follows3 7,,ii7 a qualifying other practitioner1 as defined in clause 7iv71 who is a nurse practitioner or physician assistant2 or 4 7c7 ,imposing a time limitation for clinical nurse specialists1 certified registered nurse anesthetists1 and certified nurse midwifes ,to become qualifying practitioners ,clause 7iii7 of section #cjc7;g77#b77;,g7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g771 as amended by subsection 7b71 is further amended by adding at the end the following3 7,,iii7 for the period beginning on ,october #a1 #bjah1 and ending on ,october #a1 #bjbc1 a qualifying other practitioner1 as defined in clause 7iv71 who is a clinical nurse specialist1 certified registered nurse anesthetist1 or certified nurse midwife4 4 7d7 ,definition of qualifying other practitioner ,section #cjc7;g77#b77;,g77iv7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77iv77 is amended by striking nurse practitioner or physician assistant each place it appears and inserting nurse practitioner1 clinical nurse specialist1 certified registered nurse anesthetist1 certified nurse midwife1 or physician assistant4 7e7 ,report by ,secretary ,not later than two years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in consultation with the ,drug ,enforcement ,administration1 shall submit to ,congress a report that assesses the care provided by qualifying practitioners 7as defined in section #cjc7;g77#b77;,g77iii7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77iii777 who are treating1 in the case of physicians1 #ajj or more patients1 and in the case of qualifying practitioners who are not physicians1 #cj or more patients4 ,such report shall include recommendations on future applicable patient number levels and limits4 ,in preparing such report1 the ,secretary shall study1 with respect to opioid use disorder treatment-- 7#a7 the average frequency with which qualifying practitioners see their patients2 7#b7 the average frequency with which patients receive counseling1 including the rates by which such counseling is provided by such a qualifying practitioner directly1 or by referral2 7#c7 the average frequency with which random toxicology testing is administered2 7#d7 the average monthly patient caseload for each type of qualifying practitioner2 7#e7 the treatment retention rates for patients2 7#f7 overdose and mortality rates2 and 7#g7 any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner4 ,,iv ,offsets #dja4 ,promoting value in ,medicaid managed care ,section #aijc7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77 is amended by adding at the end the following new paragraph3 7#g7 7,a7 ,with respect to expenditures described in subparagraph 7,b7 that are incurred by a ,state for any fiscal year after fiscal year #bjbj 7and before fiscal year #bjbe71 in determining the pro rata share to which the ,united ,states is equitably entitled under subsection 7d77#c71 the ,secretary shall substitute the ,federal medical assistance percentage that applies for such fiscal year to the ,state under section #aije7;b7 7without regard to any adjustments to such percentage applicable under such section or any other provision of law7 for the percentage that applies to such expenditures under section #aije7y74 7,b7 ,expenditures described in this subparagraph1 with respect to a fiscal year to which subparagraph 7,a7 applies1 are expenditures incurred by a ,state for payment for medical assistance provided to individuals described in subclause 7,,viii7 of section #aijb7;a77#aj77;,a77i7 by a managed care entity1 or other specified entity 7as defined in subparagraph 7,d77iii771 that are treated as remittances because the ,state-- 7i7 has satisfied the requirement of section #dch4h of title #db1 ,code of ,federal ,regulations 7or any successor regulation71 by electing-- 7,i7 in the case of a ,state described in subparagraph 7,c71 to apply a minimum medical loss ratio 7as defined in subparagraph 7,d77ii77 that is equal to or greater than #he percent2 or 7,,ii7 in the case of a ,state not described in subparagraph 7,c71 to apply a minimum medical loss ratio that is equal to #he percent2 and 7ii7 recovered all or a portion of the expenditures as a result of the entity's failure to meet such ratio4 7,c7 ,for purposes of subparagraph 7,b71 a ,state described in this subparagraph is a ,state that as of ,may #ca1 #bjah1 applied a minimum medical loss ratio 7as calculated under subsection 7d7 of section #dch4h of title #db1 ,code of ,federal ,regulations 7as in effect on ,june #a1 #bjah77 for payment for services provided by entities described in such subparagraph under the ,state plan under this title 7or a waiver of the plan7 that is equal to or greater than #he percent4 7,d7 ,for purposes of this paragraph3 7i7 ,the term managed care entity means a medicaid managed care organization described in section #aicb7;a77#a77;,b77i74 7ii7 ,the term minimum medical loss ratio means1 with respect to a ,state1 a minimum medical loss ratio 7as calculated under subsection 7d7 of section #dch4h of title #db1 ,code of ,federal ,regulations 7as in effect on ,june #a1 #bjah77 for payment for services provided by entities described in subparagraph 7,b7 under the ,state plan under this title 7or a waiver of the plan74 7iii7 ,the term other specified entity means-- 7,i7 a prepaid inpatient health plan1 as defined in section #dch4b of title #db1 ,code of ,federal ,regulations 7or any successor regulation72 and 7,,ii7 a prepaid ambulatory health plan1 as defined in such section 7or any successor regulation74 4 #djb4 ,extending period of application of ,medicare secondary payer rules for individuals with end stage renal disease ,section #ahfb7;b77#a77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7b77#a77;,c77 is amended-- 7#a7 in the last sentence1 by inserting and before ,january #a1 #bjbj after date of enactment of the ,balanced ,budget ,act of #aiig2 and 7#b7 by adding at the end the following new sentence3 ,effective for items and services furnished on or after ,january #a1 #bjbj 7with respect to periods beginning on or after ,july #a1 #bjah71 clauses 7i7 and 7ii7 shall be applied by substituting #cc-month for #ab-month each place it appears44 #djc4 ,requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the ,medicare program ,clause 7i7 of section #ahfb7;b77#g77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7b77#g77;,a77 is amended to read as follows3 7i7 secure from the plan sponsor and plan participants such information as the ,secretary shall specify for the purpose of identifying situations where the group health plan is or has been-- 7,i7 a primary plan to the program under this title2 or 7,,ii7 for calendar quarters beginning on or after ,january #a1 #bjbj1 a primary payer with respect to benefits relating to prescription drug coverage under part ,d2 and 4