(a) 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 Act”.

(b) Table of contents.—The table of contents of this Act is as follows:

Sec. 1. Short title; table of contents.

(a) In general.—Section 1902 of the Social Security Act (42 U.S.C. 1396a) is amended—

(1) in subsection (a)—

(A) by striking “and” at the end of paragraph (82);

(B) by striking the period at the end of paragraph (83) and inserting “; and”; and

(C) by inserting after paragraph (83) the following new paragraph:

“(84) provide that—

“(A) the State shall not terminate eligibility for medical assistance under the State plan for an individual who is an eligible juvenile (as defined in subsection (nn)(2)) because the juvenile is an inmate of a public institution (as defined in subsection (nn)(3)), but may suspend coverage during the period the juvenile is such an inmate;

“(B) in the case of an individual who is an eligible juvenile described in paragraph (2)(A) of subsection (nn), the State shall, prior to the individual’s release from such a public institution, conduct a redetermination of eligibility for such individual with respect to such medical assistance (without requiring a new application from the individual) and, if the State determines pursuant to such redetermination that the individual continues to meet the eligibility requirements for such medical assistance, the State shall restore coverage for such medical assistance to such an individual upon the individual’s release from such public institution; and

“(C) in the case of an individual who is an eligible juvenile described in paragraph (2)(B) of subsection (nn), the State shall process any application for medical assistance submitted by, or on behalf of, 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 institution.”; and

(2) by adding at the end the following new subsection:

“(nn) Juvenile; eligible juvenile; public institution.—For purposes of subsection (a)(84) and this subsection:

“(1) JUVENILE.—The term ‘juvenile’ means an individual who is—

“(A) under 21 years of age; or

“(B) described in subsection (a)(10)(A)(i)(IX).

“(2) ELIGIBLE JUVENILE.—The term ‘eligible juvenile’ means a juvenile who is an inmate of a public institution and who—

“(A) was determined eligible for medical assistance under the State plan immediately before becoming an inmate of such a public institution; or

“(B) is determined eligible for such medical assistance while an inmate of a public institution.

“(3) INMATE OF A PUBLIC INSTITUTION.—The term ‘inmate of a public institution’ has the meaning given such term for purposes of applying the subdivision (A) following paragraph (30) of section 1905(a), taking into account the exception in such subdivision for a patient of a medical institution.”.

(b) 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 (A) following paragraph (30) of section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)), as redesignated by section 1006(b)(2)(B) of this Act, including any applicable restrictions on a State submitting claims for Federal financial participation under title XIX of such Act for such assistance.

(c) No change in continuity of eligibility before adjudication or sentencing.—Nothing in this section shall be construed to mandate, encourage, or suggest that a State suspend or terminate coverage for individuals before they have been adjudicated or sentenced.

(d) Effective date.—

(1) IN GENERAL.—Except as provided in paragraph (2), the amendments made by subsection (a) shall apply to eligibility of juveniles who become inmates of public institutions on or after the date that is 1 year after the date of the enactment of this Act.

(2) 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 (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendments made by subsection (a), 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 Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.

(a) Coverage continuity for former foster care children up to age 26.—

(1) IN GENERAL.—Section 1902(a)(10)(A)(i)(IX) of the Social Security Act (42 U.S.C. 1396a(a)(10)(A)(i)(IX)) is amended—

(A) in item (bb), by striking “are not described in or enrolled under” and inserting “are not described in and are not enrolled under”;

(B) in item (cc), by striking “responsibility of the State” and inserting “responsibility of a State”; and

(C) in item (dd), 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 a”.

(2) EFFECTIVE DATE.—The amendments made by this subsection shall take effect with respect to foster youth who attain 18 years of age on or after January 1, 2023.

(b) Guidance.—Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to States, with respect to the State Medicaid programs of such States—

(1) on best practices for—

(A) removing barriers and ensuring streamlined, timely access to Medicaid coverage for former foster youth up to age 26; and

(B) conducting outreach and raising awareness among such youth regarding Medicaid coverage options for such youth; and

(2) which shall include examples of States that have successfully extended Medicaid coverage to former foster youth up to age 26.

Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended by adding at the end the following new subsection:

“(aa) Demonstration project To increase substance use provider capacity.—

“(1) IN GENERAL.—Not later than the date that is 180 days after the date of the enactment of this subsection, the Secretary shall, in consultation, as appropriate, with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, conduct a 54-month demonstration project for the purpose described in paragraph (2) under which the Secretary shall—

“(A) for the first 18-month period of such project, award planning grants described in paragraph (3); and

“(B) for the remaining 36-month period of such project, provide to each State selected under paragraph (4) payments in accordance with paragraph (5).

“(2) PURPOSE.—The purpose described in this paragraph is for each State selected under paragraph (4) to increase the treatment capacity of providers participating under the State plan (or a waiver of such plan) to provide substance use disorder treatment or recovery services under such plan (or waiver) through the following activities:

“(A) For the purpose described in paragraph (3)(C)(i), activities that support an ongoing assessment of the behavioral health treatment needs of the State, taking into account the matters described in subclauses (I) through (IV) of such paragraph.

“(B) Activities that, taking into account the results of the assessment described in subparagraph (A), support the recruitment, training, and provision of technical assistance for providers participating under the State plan (or a waiver of such plan) that offer substance use disorder treatment or recovery services.

“(C) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that—

“(i) 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 disorder;

“(ii) have in effect a registration or waiver under section 303(g) 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 303(g); and

“(iii) are qualified under applicable State law to provide substance use disorder treatment or recovery services.

“(D) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that have the qualifications to address the treatment or recovery needs of—

“(i) individuals enrolled under the State plan (or a waiver of such plan) who have neonatal abstinence syndrome, 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 syndrome;

“(ii) pregnant women, postpartum women, and infants, particularly the concurrent treatment, as appropriate, and comprehensive case management of pregnant women, post­partum women and infants, enrolled under the State plan (or a waiver of such plan);

“(iii) adolescents and young adults between the ages of 12 and 21 enrolled under the State plan (or a waiver of such plan); or

“(iv) American Indian and Alaska Native individuals enrolled under the State plan (or a waiver of such plan).

“(3) PLANNING GRANTS.—

“(A) IN GENERAL.—The Secretary shall, with respect to the first 18-month period of the demonstration project conducted under paragraph (1), award planning grants to at least 10 States selected in accordance with subparagraph (B) for purposes of preparing an application described in paragraph (4)(C) and carrying out the activities described in subparagraph (C).

“(B) SELECTION.—In selecting States for purposes of this paragraph, the Secretary shall—

“(i) select States that have a State plan (or waiver of the State plan) approved under this title;

“(ii) select States in a manner that ensures geographic diversity; and

“(iii) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate.

“(C) ACTIVITIES DESCRIBED.—Activities described in this subparagraph are, with respect to a State, each of the following:

“(i) 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 (including the types of such providers and geographic area of need) to improve the network of providers that treat substance use disorders under the State plan (or waiver), including the following:

“(I) An estimate of the number of individuals enrolled under the State plan (or a waiver of such plan) who have a substance use disorder.

“(II) Information on the capacity of providers to provide substance use disorder treatment or recovery services to individuals enrolled under the State plan (or waiver), including information on providers who provide such services and their participation under the State plan (or waiver).

“(III) Information on the gap in substance use disorder treatment or recovery services under the State plan (or waiver) based on the information described in subclauses (I) and (II).

“(IV) 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 (or waiver) during the period of the demonstration project.

“(ii) Activities that, taking into account the results of the assessment described in clause (i), support the development of State infrastructure to, with respect to the provision of substance use disorder treatment or recovery services under the State plan (or a waiver of such plan), recruit prospective providers and provide training and technical assistance to such providers.

“(D) FUNDING.—For purposes of subparagraph (A), there is appropriated, out of any funds in the Treasury not otherwise appropriated, $50,000,000, to remain available until expended.

“(4) POST-PLANNING STATES.—

“(A) IN GENERAL.—The Secretary shall, with respect to the remaining 36-month period of the demonstration project conducted under paragraph (1), select not more than 5 States in accordance with subparagraph (B) for purposes of carrying out the activities described in paragraph (2) and receiving payments in accordance with paragraph (5).

“(B) SELECTION.—In selecting States for purposes of this paragraph, the Secretary shall—

“(i) select States that received a planning grant under paragraph (3);

“(ii) select States that submit to the Secretary an application in accordance with the requirements in subparagraph (C), taking into consideration the quality of each such application;

“(iii) select States in a manner that ensures geographic diversity; and

“(iv) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate.

“(C) APPLICATIONS.—

“(i) IN GENERAL.—A State seeking to be selected for purposes of this paragraph shall submit to the Secretary, at such time and in such form and manner as the Secretary requires, an application that includes such information, provisions, and assurances, as the Secretary may require, in addition to the following:

“(I) A proposed process for carrying out the ongoing assessment described in paragraph (2)(A), taking into account the results of the initial assessment described in paragraph (3)(C)(i).

“(II) A review of reimbursement methodologies and other policies related to substance use disorder treatment or recovery services under the State plan (or waiver) that may create barriers to increasing the number of providers delivering such services.

“(III) The development of a plan, taking into account activities carried out under paragraph (3)(C)(ii), that will result in long-term and sustainable provider networks under the State plan (or waiver) that will offer a continuum of care for substance use disorders. Such plan shall include the following:

“(aa) Specific activities to increase the number of providers (including providers that specialize in providing substance use disorder treatment or recovery services, hospitals, health care systems, Federally qualified health centers, and, as applicable, certified community behavioral health clinics) that offer substance use disorder treatment, recovery, or support services, including short-term detoxification services, outpatient substance use disorder services, and evidence-based peer recovery services.

“(bb) Strategies that will incentivize providers described in subparagraphs (C) and (D) of paragraph (2) to obtain the necessary training, education, and support to deliver substance use disorder treatment or recovery services in the State.

“(cc) Milestones and timeliness for implementing activities set forth in the plan.

“(dd) Specific measurable targets for increasing the substance use disorder treatment and recovery provider network under the State plan (or a waiver of such plan).

“(IV) A proposed process for reporting the information required under paragraph (6)(A), 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 subsection.

“(V) The expected financial impact of the demonstration project under this subsection on the State.

“(VI) A description of all funding sources available to the State to provide substance use disorder treatment or recovery services in the State.

“(VII) 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 project.

“(VIII) A description of how the State will coordinate the goals of the demonstration project with any waiver granted (or submitted by the State and pending) pursuant to section 1115 for the delivery of substance use services under the State plan, as applicable.

“(ii) CONSULTATION.—In completing an application under clause (i), a State shall consult with relevant stakeholders, including Medicaid managed care plans, health care providers, and Medicaid beneficiary advocates, and include in such application a description of such consultation.

“(5) PAYMENT.—

“(A) IN GENERAL.—For each quarter occurring during the period for which the demonstration project is conducted (after the first 18 months of such period), the Secretary shall pay under this subsection, subject to subparagraph (C), to each State selected under paragraph (4) an amount equal to 80 percent of so much of the qualified sums expended during such quarter.

“(B) QUALIFIED SUMS DEFINED.—For purposes of subparagraph (A), the term ‘qualified sums’ means, with respect to a State and a quarter, the amount equal to the amount (if any) by which the sums expended by the State during such quarter attributable to substance use disorder treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan) exceeds 1/4 of such sums expended by the State during fiscal year 2018 attributable to substance use disorder treatment or recovery services.

“(C) NON-DUPLICATION OF PAYMENT.—In the case that payment is made under subparagraph (A) with respect to expenditures for substance use disorder treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan), payment may not also be made under subsection (a) with respect to expenditures for the same services so furnished.

“(6) REPORTS.—

“(A) STATE REPORTS.—A State receiving payments under paragraph (5) shall, for the period of the demonstration project under this subsection, submit to the Secretary a quarterly report, with respect to expenditures for substance use disorder treatment or recovery services for which payment is made to the State under this subsection, on the following:

“(i) The specific activities with respect to which payment under this subsection was provided.

“(ii) 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 project.

“(iii) The number of individuals enrolled under the State plan (or a waiver of such plan) 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 project.

“(iv) Other matters as determined by the Secretary.

“(B) CMS REPORTS.—

“(i) INITIAL REPORT.—Not later than October 1, 2020, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an initial report on—

“(I) the States awarded planning grants under paragraph (3);

“(II) the criteria used in such selection; and

“(III) the activities carried out by such States under such planning grants.

“(ii) INTERIM REPORT.—Not later than October 1, 2022, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an interim report—

“(I) on activities carried out under the demonstration project under this subsection;

“(II) on the extent to which States selected under paragraph (4) have achieved the stated goals submitted in their applications under subparagraph (C) of such paragraph;

“(III) with a description of the strengths and limitations of such demonstration project; and

“(IV) with a plan for the sustainability of such project.

“(iii) FINAL REPORT.—Not later than October 1, 2024, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress a final report—

“(I) providing updates on the matters reported in the interim report under clause (ii);

“(II) including a description of any changes made with respect to the demonstration project under this subsection after the submission of such interim report; and

“(III) evaluating such demonstration project.

“(C) AHRQ REPORT.—Not later than 3 years after the date of the enactment of this subsection, the Director of the Agency for Healthcare Research and Quality, in consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall submit to Congress a summary on the experiences of States awarded planning grants under paragraph (3) and States selected under paragraph (4).

“(7) DATA SHARING AND BEST PRACTICES.—During the period of the demonstration project under this subsection, the Secretary shall, in collaboration with States selected under paragraph (4), facilitate data sharing and the development of best practices between such States and States that were not so selected.

“(8) CMS FUNDING.—There is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 to the Centers for Medicare & Medicaid Services for purposes of implementing this subsection. Such amount shall remain available until expended.”.

(a) Medicaid drug utilization review.—

(1) STATE PLAN REQUIREMENT.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)), as amended by section 1001, is further amended—

(A) in paragraph (83), at the end, by striking “and”;

(B) in paragraph (84), at the end, by striking the period and inserting “; and”; and

(C) by inserting after paragraph (84) the following new paragraph:

“(85) provide that the State is in compliance with the drug review and utilization requirements under subsection (oo)(1).”.

(2) DRUG REVIEW AND UTILIZATION REQUIREMENTS.—Section 1902 of the Social Security Act (42 U.S.C. 1396a), as amended by section 1001, is further amended by adding at the end the following new subsection:

“(oo) Drug review and utilization requirements.—

“(1) IN GENERAL.—For purposes of subsection (a)(85), the drug review and utilization requirements under this subsection are, subject to paragraph (3) and beginning October 1, 2019, the following:

“(A) CLAIMS REVIEW LIMITATIONS.—

“(i) IN GENERAL.—The State has in place—

“(I) safety edits (as specified by the State) for subsequent fills for opioids and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the State plan (or under a waiver of the State plan) is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the State;

“(II) safety edits (as specified by the State) on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the State plan (or under a waiver of the State plan) for treatment of chronic pain and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the plan (or waiver) is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the State; and

“(III) a claims review automated process (as designed and implemented by the State) that monitors when an individual enrolled under the State plan (or under a waiver of the State plan) is concurrently prescribed opioids and—

“(aa) benzodiazepines; or

“(bb) antipsychotics.

“(ii) MANAGED CARE ENTITIES.—The State requires each managed care entity (as defined in section 1932(a)(1)(B)) with respect to which the State has a contract under section 1903(m) or under section 1905(t)(3) to have in place, subject to paragraph (3), with respect to individuals who are eligible for medical assistance under the State plan (or under a waiver of the State plan) and who are enrolled with the entity, the limitations described in subclauses (I) and (II) of clause (i) and a claims review automated process described in subclause (III) of such clause.

“(iii) 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 claims. 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 (or waiver of the State plan) or contracting with a managed care entity regarding the best items and services for an individual enrolled under such State plan (or waiver).

“(B) PROGRAM TO MONITOR ANTIPSYCHOTIC MEDICATIONS BY CHILDREN.—The State has in place a program (as designed and implemented by the State) to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the State plan (or under a waiver of the State plan) 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 18 years generally and children in foster care specifically.

“(C) FRAUD AND ABUSE IDENTIFICATION.—The State has in place a process (as designed and implemented by the State) that identifies potential fraud or abuse of controlled substances by individuals enrolled under the State plan (or under a waiver of the State plan), health care providers prescribing drugs to individuals so enrolled, and pharmacies dispensing drugs to individuals so enrolled.

“(D) REPORTS.—The State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D) information on the limitations, requirement, program, and processes applied by the State under subparagraphs (A) through (C) in accordance with such manner and time as specified by the Secretary.

“(E) CLARIFICATION.—Nothing shall prevent a State from satisfying the requirement—

“(i) described in subparagraph (A) by having safety edits or a claims review automated process described in such subparagraph that was in place before October 1, 2019;

“(ii) described in subparagraph (B) by having a program described in such subparagraph that was in place before such date; or

“(iii) described in subparagraph (C) by having a process described in such subparagraph that was in place before such date.

“(2) ANNUAL REPORT BY SECRETARY.—For each fiscal year beginning with fiscal year 2020, the Secretary shall submit to Congress a report on the most recent information submitted by States under paragraph (1)(D).

“(3) EXCEPTIONS.—

“(A) CERTAIN INDIVIDUALS EXEMPTED.—The drug review and utilization requirements under this subsection shall not apply with respect to an individual who—

“(i) is receiving—

“(I) hospice or palliative care; or

“(II) treatment for cancer;

“(ii) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or

“(iii) the State elects to treat as exempted from such requirements.

“(B) EXCEPTION RELATING TO ENSURING ACCESS.—In order to ensure reasonable access to health care, the Secretary shall waive the drug review and utilization requirements under this subsection, with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)).”.

(3) MANAGED CARE ENTITIES.—Section 1932 of the Social Security Act (42 U.S.C. 1396u–2) is amended by adding at the end the following new subsection:

“(i) Drug utilization review activities and requirements.—Beginning not later than October 1, 2019, each contract under a State plan with a managed care entity (other than a primary care case manager) under section 1903(m) shall provide that the entity is in compliance with the applicable provisions of section 438.3(s)(2) of title 42, Code of Federal Regulations, section 483.3(s)(4)) of such title, and section 483.3(s)(5) of such title, as such provisions were in effect on March 31, 2018.”.

(b) Identifying and addressing inappropriate prescribing and billing practices under Medicaid.—

(1) IN GENERAL.—Section 1927(g) of the Social Security Act (42 U.S.C. 1396r–8(g)) is amended—

(A) in paragraph (1)(A)—

(i) by striking “of section 1903(i)(10)(B)” and inserting “of section 1902(a)(54)”;

(ii) by striking “, by not later than January 1, 1993,”;

(iii) by inserting after “gross overuse,” the following: “excessive utilization,”; and

(iv) by striking “or inappropriate or medically unnecessary care” and inserting “inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization”; and

(B) in paragraph (2)(B)—

(i) by inserting after “gross overuse,” the following: “excessive utilization,”; and

(ii) by striking “or inappropriate or medically unnecessary care” and inserting “inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization”.

(2) EFFECTIVE DATE.—The amendments made by paragraph (1) shall take effect with respect to retrospective drug use reviews conducted on or after October 1, 2020.

(a) Guidance.—Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to improve care for infants with neonatal abstinence syndrome and their families. Such guidance shall include—

(1) best practices from States with respect to innovative or evidenced-based payment models that focus on prevention, screening, treatment, plans of safe care, and postdischarge services for mothers and fathers with substance use disorders and babies with neonatal abstinence syndrome that improve care and clinical outcomes;

(2) 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 disorders, infants with neonatal abstinence syndrome, and home-visiting services;

(3) guidance and technical assistance to State Medicaid agencies regarding additional flexibilities and incentives related to screening, prevention, and postdischarge services, including parenting supports, and infant-caregiver bonding, including breastfeeding when it is appropriate; and

(4) guidance regarding suggested terminology and ICD codes to identify infants with neonatal abstinence syndrome and neonatal opioid withdrawal syndrome, which could include opioid-exposure, opioid withdrawal not requiring pharmacotherapy, and opioid withdrawal requiring pharmacotherapy.

(b) GAO study.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, addressing gaps in coverage for pregnant women with substance use disorder under the Medicaid program under title XIX of the Social Security Act, and gaps in coverage for postpartum women with substance use disorder who had coverage during their pregnancy under the Medicaid program under such title.

(a) Extension of enhanced FMAP for certain health homes for individuals with substance use disorders.—Section 1945(c) of the Social Security Act (42 U.S.C. 1396w–4(c)) is amended—

(1) in paragraph (1), by inserting “subject to paragraph (4),” after “except that,”; and

(2) by adding at the end the following new paragraph:

“(4) SPECIAL RULE RELATING TO SUBSTANCE USE DISORDER HEALTH HOMES.—

“(A) IN GENERAL.—In the case of a State with an SUD-focused State plan amendment approved by the Secretary on or after October 1, 2018, the Secretary may, at the request of the State, extend the application of the Federal medical assistance percentage described in paragraph (1) to payments for the provision of health home services to SUD-eligible individuals under such State plan amendment, in addition to the first 8 fiscal year quarters the State plan amendment is in effect, for the subsequent 2 fiscal year quarters that the State plan amendment is in effect. 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 section, including for purposes of application of this paragraph.

“(B) 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 (A), such State shall, at the end of the period of such State plan amendment, submit to the Secretary a report on the following, with respect to SUD-eligible individuals provided health home services under such State plan amendment:

“(i) The quality of health care provided to such individuals, with a focus on outcomes relevant to the recovery of each such individual.

“(ii) The access of such individuals to health care.

“(iii) The total expenditures of such individuals for health care.

For purposes of this subparagraph, the Secretary shall specify all applicable measures for determining quality, access, and expenditures.

“(C) BEST PRACTICES.—Not later than October 1, 2020, 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 amendment, based on the experiences of States that have State plan amendments approved under this section that include SUD-eligible individuals.

“(D) DEFINITIONS.—For purposes of this paragraph:

“(i) SUD-ELIGIBLE INDIVIDUALS.—The term ‘SUD-eligible individual’ means, with respect to a State, an individual who satisfies all of the following:

“(I) The individual is an eligible individual with chronic conditions.

“(II) The individual is an individual with a substance use disorder.

“(III) The individual has not previously received health home services under any other State plan amendment approved for the State under this section by the Secretary.

“(ii) 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 individuals.”.

(b) Requirement for State Medicaid plans To provide coverage for medication-Assisted treatment.—

(1) REQUIREMENT FOR STATE MEDICAID PLANS TO PROVIDE COVERAGE FOR MEDICATION-ASSISTED TREATMENT.—Section 1902(a)(10)(A) of the Social Security Act (42 U.S.C. 1396a(a)(10)(A)) is amended, in the matter preceding clause (i), by striking “and (28)” and inserting “(28), and (29)”.

(2) INCLUSION OF MEDICATION-ASSISTED TREATMENT AS MEDICAL ASSISTANCE.—Section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) is amended—

(A) in paragraph (28), by striking “and” at the end;

(B) by redesignating paragraph (29) as paragraph (30); and

(C) by inserting after paragraph (28) the following new paragraph:

“(29) subject to paragraph (2) of subsection (ee), for the period beginning October 1, 2020, and ending September 30, 2025, medication-assisted treatment (as defined in paragraph (1) of such subsection); and”.

(3) MEDICATION-ASSISTED TREATMENT DEFINED; WAIVERS.—Section 1905 of the Social Security Act (42 U.S.C. 1396d) is amended by adding at the end the following new subsection:

“(ee) Medication-Assisted treatment.—

“(1) DEFINITION.—For purposes of subsection (a)(29), the term ‘medication-assisted treatment’—

“(A) means all drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), including methadone, and all biological products licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) to treat opioid use disorders; and

“(B) includes, with respect to the provision of such drugs and biological products, counseling services and behavioral therapy.

“(2) EXCEPTION.—The provisions of paragraph (29) of subsection (a) shall not apply with respect to a State for the period specified in such paragraph, 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 (or waiver of the State plan) would not be feasible by reason of a shortage of qualified providers of medication-assisted treatment, or facilities providing such treatment, that will contract with the State or a managed care entity with which the State has a contract under section 1903(m) or under section 1905(t)(3).”.

(4) EFFECTIVE DATE.—

(A) IN GENERAL.—Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to medical assistance provided on or after October 1, 2020, and before October 1, 2025.

(B) EXCEPTION FOR STATE LEGISLATION.—In the case of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) 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 subsection, 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 Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature.

(a) State plan amendment.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)), as amended by sections 1001 and 1004, is further amended—

(1) in paragraph (84)(C), by striking “and” after the semicolon;

(2) in paragraph (85), by striking the period at the end and inserting “; and”; and

(3) by inserting after paragraph (85), the following new paragraph:

“(86) provide, at the option of the State, for making medical assistance available on an inpatient or outpatient basis at a residential pediatric recovery center (as defined in subsection (pp)) to infants with neonatal abstinence syndrome.”.

(b) Residential pediatric recovery center defined.—Section 1902 of such Act (42 U.S.C. 1396a), as amended by sections 1001 and 1004, is further amended by adding at the end the following new subsection:

“(pp) Residential pediatric recovery center defined.—

“(1) IN GENERAL.—For purposes of section 1902(a)(86), the term ‘residential pediatric recovery center’ means a center or facility that furnishes items and services for which medical assistance is available under the State plan to infants with the diagnosis of neonatal abstinence syndrome without any other significant medical risk factors.

“(2) COUNSELING AND SERVICES.—A residential pediatric recovery center may offer counseling and other services to mothers (and other appropriate family members and caretakers) of infants receiving treatment at such centers if such services are otherwise covered under the State plan under this title or under a waiver of such plan. Such other services may include the following:

“(A) Counseling or referrals for services.

“(B) Activities to encourage caregiver-infant bonding.

“(C) Training on caring for such infants.”.

(c) Effective date.—The amendments made by this section take effect on the date of enactment of this Act and shall apply to medical assistance furnished on or after that date, without regard to final regulations to carry out such amendments being promulgated as of such date.

(a) In general.—Not later than 2 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Finance of the Senate, and the Committee on Health, Education, Labor and Pensions of the Senate a report on the provision of peer support services under the Medicaid program.

(b) Content of report.—

(1) IN GENERAL.—The report required under subsection (a) shall include the following information:

(A) Information on State coverage of peer support services under Medicaid, including—

(i) the mechanisms through which States may provide such coverage, including through existing statutory authority or through waivers;

(ii) the populations to which States have provided such coverage;

(iii) the payment models, including any alternative payment models, used by States to pay providers of such services; and

(iv) where available, information on Federal and State spending under Medicaid for peer support services.

(B) Information on selected State experiences in providing medical assistance for peer support services under State Medicaid plans and whether States measure the effects of providing such assistance with respect to—

(i) improving access to behavioral health services;

(ii) improving early detection, and preventing worsening, of behavioral health disorders;

(iii) reducing chronic and comorbid conditions; and

(iv) reducing overall health costs.

(2) RECOMMENDATIONS.—The report required under subsection (a) shall include recommendations, including recommendations for such legislative and administrative actions related to improving services, including peer support services, and access to peer support services under Medicaid as the Comptroller General of the United States determines appropriate.

(a) Definitions.—In this section:

(1) COMPTROLLER GENERAL.—The term “Comptroller General” means the Comptroller General of the United States.

(2) SCHOOL-BASED HEALTH CENTER.—The term “school-based health center” has the meaning given that term in section 2110(c)(9) of the Social Security Act (42 U.S.C. 1397jj(c)(9)).

(3) SECRETARY.—The term “Secretary” means the Secretary of Health and Human Services.

(4) UNDERSERVED AREA.—The term “underserved area” means a health professional shortage area (as defined in section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A))) and a medically underserved area (according to a designation under section 330(b)(3)(A) of the Public Health Service Act (42 U.S.C. 254b(b)(3)(A))).

(b) Guidance to States regarding Federal reimbursement for furnishing services and treatment for substance use disorders under Medicaid using services delivered via telehealth, including in school-Based health centers.—Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue guidance to States on the following:

(1) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders, including assessment, medication-assisted treatment, counseling, medication management, and medication adherence with prescribed medication regimes, using services delivered via telehealth. Such guidance shall also include guidance on furnishing services and treatments that address the needs of high-risk individuals, including at least the following groups:

(A) American Indians and Alaska Natives.

(B) Adults under the age of 40.

(C) Individuals with a history of non-fatal overdose.

(D) Individuals with a co-occurring serious mental illness and substance use disorder.

(2) State options for Federal reimbursement of expenditures under Medicaid for education directed to providers serving Medicaid beneficiaries with substance use disorders using the hub and spoke model, through contracts with managed care entities, through administrative claiming for disease management activities, and under Delivery System Reform Incentive Payment (“DSRIP”) programs.

(3) State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders for individuals enrolled in Medicaid in a school-based health center using services delivered via telehealth.

(c) GAO evaluation of children's access to services and treatment for substance use disorders under Medicaid.—

(1) STUDY.—The Comptroller General shall evaluate children’s access to services and treatment for substance use disorders under Medicaid. The evaluation shall include an analysis of State options for improving children's access to such services and treatment and for improving outcomes, including by increasing the number of Medicaid providers who offer services or treatment for substance use disorders in a school-based health center using services delivered via telehealth, particularly in rural and underserved areas. The evaluation shall include an analysis of Medicaid provider reimbursement rates for services and treatment for substance use disorders.

(2) REPORT.—Not later than 1 year after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the evaluation conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

(d) Report on reducing barriers to using services delivered via telehealth and remote patient monitoring for pediatric populations under Medicaid.—

(1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a report to the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representatives identifying best practices and potential solutions for reducing barriers to using services delivered via telehealth to furnish services and treatment for substance use disorders among pediatric populations under Medicaid. The report shall include—

(A) analyses of the best practices, barriers, and potential solutions for using services delivered via telehealth to diagnose and provide services and treatment for children with substance use disorders, including opioid use disorder; and

(B) identification and analysis of the differences, if any, in furnishing services and treatment for children with substance use disorders using services delivered via telehealth and using services delivered in person, such as, and to the extent feasible, with respect to—

(i) utilization rates;

(ii) costs;

(iii) avoidable inpatient admissions and readmissions;

(iv) quality of care; and

(v) patient, family, and provider satisfaction.

(2) PUBLICATION.—The Secretary shall publish the report required under paragraph (1) on a public internet website of the Department of Health and Human Services.

Not later than January 1, 2019, the Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue 1 or more final guidance documents, or update existing guidance documents, to States regarding mandatory and optional items and services that may be provided under a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or under a waiver of such a plan, for non-opioid treatment and management of pain, including, but not limited to, evidence-based, non-opioid pharmacological therapies and non-pharmacological therapies.

(a) Study.—

(1) IN GENERAL.—The Comptroller General of the United States (in this section referred to as the “Comptroller General”) shall conduct a study regarding the barriers to providing medication used in the treatment of substance use disorders under Medicaid distribution models such as the “buy-and-bill” model, and options for State Medicaid programs to remove or reduce such barriers. The study shall include analyses of each of the following models of distribution of substance use disorder treatment medications, particularly buprenorphine, naltrexone, and buprenorphine-naloxone combinations:

(A) The purchasing, storage, and administration of substance use disorder treatment medications by providers.

(B) The dispensing of substance use disorder treatment medications by pharmacists.

(C) The ordering, prescribing, and obtaining substance use disorder treatment medications on demand from specialty pharmacies by providers.

(2) REQUIREMENTS.—For each model of distribution specified in paragraph (1), the Comptroller General shall evaluate how each model presents barriers or could be used by selected State Medicaid programs to reduce the barriers related to the provision of substance use disorder treatment by examining what is known about the effects of the model of distribution on—

(A) Medicaid beneficiaries’ access to substance use disorder treatment medications;

(B) the differential cost to the program between each distribution model for medication-assisted treatment; and

(C) provider willingness to provide or prescribe substance use disorder treatment medications.

(b) Report.—Not later than 15 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

(a) Medicaid State plan.—Section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)), as amended by section 1006, is further amended by adding at the end the following new sentence: “In the case of a woman who is eligible for medical assistance on the basis of being pregnant (including through the end of the month in which the 60-day period beginning on the last day of her pregnancy ends), who is a patient in an institution for mental diseases for purposes of receiving treatment for a substance use disorder, and who was enrolled for medical assistance under the State plan immediately before becoming a patient in an institution for mental diseases or who becomes eligible to enroll for such medical assistance while such a patient, the exclusion from the definition of ‘medical assistance’ set forth in the subdivision (B) following paragraph (30) of the first sentence of this subsection shall not be construed as prohibiting Federal financial participation for medical assistance for items or services that are provided to the woman outside of the institution.”.

(b) Effective date.—

(1) IN GENERAL.—Except as provided in paragraph (2), the amendment made by subsection (a) shall take effect on the date of enactment of this Act.

(2) RULE FOR CHANGES REQUIRING STATE LEGISLATION.—In the case of a State plan under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendment made by subsection (a), 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 Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.

Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)) is amended by adding at the end the following new paragraph:

“(7) Payment shall be made under this title to a State for expenditures for capitation payments described in section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation).”.

(a) Study.—The Medicaid and CHIP Payment and Access Commission shall conduct a study and analysis of utilization control policies applied to medication-assisted treatment for substance use disorders under State Medicaid programs, including policies and procedures applied both in fee-for-service Medicaid and in risk-based managed care Medicaid, which shall—

(1) include an inventory of such utilization control policies and related protocols for ensuring access to medically necessary treatment;

(2) determine whether managed care utilization control policies and procedures for medication-assisted treatment for substance use disorders are consistent with section 438.210(a)(4)(ii) of title 42, Code of Federal Regulations; and

(3) identify policies that—

(A) limit an individual's access to medication-assisted treatment for a substance use disorder by limiting the quantity of medication-assisted treatment prescriptions, or the number of refills for such prescriptions, available to the individual as part of a prior authorization process or similar utilization protocols; and

(B) apply without evaluating individual instances of fraud, waste, or abuse.

(b) Report.—Not later than 1 year after the date of the enactment of this Act, the Medicaid and CHIP Payment and Access Commission shall make publicly available a report containing the results of the study conducted under subsection (a).

(a) T–MSIS substance use disorder data book.—

(1) IN GENERAL.—Not later than the date that is 12 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall publish on the public website of the Centers for Medicare & Medicaid Services a report with comprehensive data on the prevalence of substance use disorders in the Medicaid beneficiary population and services provided for the treatment of substance use disorders under Medicaid.

(2) CONTENT OF REPORT.—The report required under paragraph (1) shall include, at a minimum, the following data for each State (including, to the extent available, for the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa):

(A) The number and percentage of individuals enrolled in the State Medicaid plan or waiver of such plan in each of the major enrollment categories (as defined in a public letter from the Medicaid and CHIP Payment and Access Commission to the Secretary) who have been diagnosed with a substance use disorder and whether such individuals are enrolled under the State Medicaid plan or a waiver of such plan, including the specific waiver authority under which they are enrolled, to the extent available.

(B) A list of the substance use disorder treatment services by each major type of service, such as counseling, medication-assisted treatment, peer support, residential treatment, and inpatient care, for which beneficiaries in each State received at least 1 service under the State Medicaid plan or a waiver of such plan.

(C) The number and percentage of individuals with a substance use disorder diagnosis enrolled in the State Medicaid plan or waiver of such plan who received substance use disorder treatment services under such plan or waiver by each major type of service under subparagraph (B) within each major setting type, such as outpatient, inpatient, residential, and other home-based and community-based settings.

(D) The number of services provided under the State Medicaid plan or waiver of such plan per individual with a substance use disorder diagnosis enrolled in such plan or waiver for each major type of service under subparagraph (B).

(E) The number and percentage of individuals enrolled in the State Medicaid plan or waiver, by major enrollment category, who received substance use disorder treatment through—

(i) a medicaid managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act (42 U.S.C. 1396u–2(a)(1)(B))), including the number of such individuals who received such assistance through a prepaid inpatient health plan or a prepaid ambulatory health plan;

(ii) a fee-for-service payment model; or

(iii) an alternative payment model, to the extent available.

(F) The number and percentage of individuals with a substance use disorder who receive substance use disorder treatment services in an outpatient or home-based and community-based setting after receiving treatment in an inpatient or residential setting, and the number of services received by such individuals in the outpatient or home-based and community-based setting.

(3) ANNUAL UPDATES.—The Secretary shall issue an updated version of the report required under paragraph (1) not later than January 1 of each calendar year through 2024.

(4) USE OF T–MSIS DATA.—The report required under paragraph (1) and updates required under paragraph (3) shall—

(A) use data and definitions from the Transformed Medicaid Statistical Information System (“T–MSIS”) data set that is no more than 12 months old on the date that the report or update is published; and

(B) as appropriate, include a description with respect to each State of the quality and completeness of the data and caveats describing the limitations of the data reported to the Secretary by the State that is sufficient to communicate the appropriate uses for the information.

(b) Making T–MSIS data on substance use disorders available to researchers.—

(1) IN GENERAL.—The Secretary shall publish in the Federal Register a system of records notice for the data specified in paragraph (2) for the Transformed Medicaid Statistical Information System, in accordance with section 552a(e)(4) of title 5, United States Code. The notice shall outline policies that protect the security and privacy of the data that, at a minimum, meet the security and privacy policies of SORN 09–70–0541 for the Medicaid Statistical Information System.

(2) REQUIRED DATA.—The data covered by the systems of records notice required under paragraph (1) shall be sufficient for researchers and States to analyze the prevalence of substance use disorders in the Medicaid beneficiary population and the treatment of substance use disorders under Medicaid across all States (including the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa), forms of treatment, and treatment settings.

(3) INITIATION OF DATA-SHARING ACTIVITIES.—Not later than January 1, 2019, the Secretary shall initiate the data-sharing activities outlined in the notice required under paragraph (1).

(a) In general.—Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), as amended by section 1013, is further amended by adding at the end the following new paragraph:

“(8) (A) The State agency administering the State plan under this title may have reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State to the extent the State agency is permitted to access such databases under State law.

“(B) Such State agency may facilitate reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State, to same extent that the State agency is permitted under State law to access such databases, for—

“(i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and

“(ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3).

“(C) Such State agency may share information in such databases, to the same extent that the State agency is permitted under State law to share information in such databases, with—

“(i) any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and

“(ii) any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3).”.

(b) Security and privacy.—All applicable State and Federal security and privacy protections and laws shall apply to any State agency, individual, or entity accessing 1 or more prescription drug monitoring program databases or obtaining information in such databases in accordance with section 1903(m)(8) of the Social Security Act (as added by subsection (a)).

(c) Effective date.—The amendment made by subsection (a) shall take effect on the date of enactment of this Act.

(a) In general.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a report to Congress describing innovative State initiatives and strategies for providing housing-related services and supports under a State Medicaid program to individuals with substance use disorders who are experiencing or at risk of experiencing homelessness.

(b) Content of report.—The report required under subsection (a) shall describe the following:

(1) Existing methods and innovative strategies developed and adopted by State Medicaid programs that have achieved positive outcomes in increasing housing stability among Medicaid beneficiaries with substance use disorders who are experiencing or at risk of experiencing homelessness, including Medicaid beneficiaries with substance use disorders who are—

(A) receiving treatment for substance use disorders in inpatient, residential, outpatient, or home-based and community-based settings;

(B) transitioning between substance use disorder treatment settings; or

(C) living in supportive housing or another model of affordable housing.

(2) Strategies employed by Medicaid managed care organizations, primary care case managers, hospitals, accountable care organizations, and other care coordination providers to deliver housing-related services and supports and to coordinate services provided under State Medicaid programs across different treatment settings.

(3) Innovative strategies and lessons learned by States with Medicaid waivers approved under section 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n), including—

(A) challenges experienced by States in designing, securing, and implementing such waivers or plan amendments;

(B) how States developed partnerships with other organizations such as behavioral health agencies, State housing agencies, housing providers, health care services agencies and providers, community-based organizations, and health insurance plans to implement waivers or State plan amendments; and

(C) how and whether States plan to provide Medicaid coverage for housing-related services and supports in the future, including by covering such services and supports under State Medicaid plans or waivers.

(4) Existing opportunities for States to provide housing-related services and supports through a Medicaid waiver under sections 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n) or through a State Medicaid plan amendment, such as the Assistance in Community Integration Service pilot program, which promotes supportive housing and other housing-related supports under Medicaid for individuals with substance use disorders and for which Maryland has a waiver approved under such section 1115 to conduct the program.

(5) Innovative strategies and partnerships developed and implemented by State Medicaid programs or other entities to identify and enroll eligible individuals with substance use disorders who are experiencing or at risk of experiencing homelessness in State Medicaid programs.

(a) In general.—The Secretary of Health and Human Services shall provide technical assistance and support to States regarding the development and expansion of innovative State strategies (including through State Medicaid demonstration projects) to provide housing-related supports and services and care coordination services under Medicaid to individuals with substance use disorders.

(b) Report.—Not later than 180 days after the date of enactment of this Act, the Secretary shall issue a report to Congress detailing a plan of action to carry out the requirements of subsection (a).

(a) In general.—Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—

(1) in paragraph (2)(B)—

(A) in clause (i), in the matter preceding subclause (I), by striking “clause (ii)” and inserting “clause (ii) and paragraph (6)(C)”; and

(B) in clause (ii), in the heading, by striking “for home dialysis therapy”;

(2) in paragraph (4)(C)—

(A) in clause (i), by striking “paragraph (6)” and inserting “paragraphs (5), (6), and (7)”; and

(B) in clause (ii)(X), by inserting “or telehealth services described in paragraph (7)” before the period at the end; and

(3) by adding at the end the following new paragraph:

“(7) TREATMENT OF SUBSTANCE USE DISORDER SERVICES FURNISHED THROUGH TELEHEALTH.—The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after July 1, 2019, to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder, as determined by the Secretary, at an originating site described in paragraph (4)(C)(ii) (other than an originating site described in subclause (IX) of such paragraph).”.

(b) Implementation.—The Secretary of Health and Human Services (in this section referred to as the “Secretary”) may implement the amendments made by this section by interim final rule.

(c) Report.—

(1) IN GENERAL.—Not later than 5 years after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the impact of the implementation of the amendments made by this section with respect to telehealth services under section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) on—

(A) the utilization of health care items and services under title XVIII of such Act (42 U.S.C. 1395 et seq.) related to substance use disorders, including emergency department visits; and

(B) health outcomes related to substance use disorders, such as opioid overdose deaths.

(2) FUNDING.—For purposes of carrying out paragraph (1), in addition to funds otherwise available, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $3,000,000 to the Centers for Medicare & Medicaid Services Program Management Account to remain available until expended.

(a) Initial preventive physical examination.—Section 1861(ww) of the Social Security Act (42 U.S.C. 1395x(ww)) is amended—

(1) in paragraph (1)—

(A) by striking “paragraph (2) and” and inserting “paragraph (2),”; and

(B) by inserting “and the furnishing of a review of any current opioid prescriptions (as defined in paragraph (4)),” after “upon the agreement with the individual,”; and

(2) in paragraph (2)—

(A) by redesignating subparagraph (N) as subparagraph (O); and

(B) by inserting after subparagraph (M) the following new subparagraph:

“(N) Screening for potential substance use disorders.”; and

(3) by adding at the end the following new paragraph:

“(4) For purposes of paragraph (1), the term ‘a review of any current opioid prescriptions’ means, with respect to an individual determined to have a current prescription for opioids—

“(A) a review of the potential risk factors to the individual for opioid use disorder;

“(B) an evaluation of the individual's severity of pain and current treatment plan;

“(C) the provision of information on non-opioid treatment options; and

“(D) a referral to a specialist, as appropriate.”.

(b) Annual wellness visit.—Section 1861(hhh)(2) of the Social Security Act (42 U.S.C. 1395x(hhh)(2)) is amended—

(1) by redesignating subparagraph (G) as subparagraph (I); and

(2) by inserting after subparagraph (F) the following new subparagraphs:

“(G) Screening for potential substance use disorders and referral for treatment as appropriate.

“(H) The furnishing of a review of any current opioid prescriptions (as defined in subsection (ww)(4)).”.

(c) Rule of construction.—Nothing in the amendments made by subsection (a) or (b) shall be construed to prohibit separate payment for structured assessment and intervention services for substance abuse furnished to an individual on the same day as an initial preventive physical examination or an annual wellness visit.

(d) Effective date.—The amendments made by this section shall apply to examinations and visits furnished on or after January 1, 2020.

(a) In general.—Section 1860D–4(e) of the Social Security Act (42 U.S.C. 1395w–104(e)) is amended by adding at the end the following:

“(7) REQUIREMENT OF E-PRESCRIBING FOR CONTROLLED SUBSTANCES.—

“(A) IN GENERAL.—Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, 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 (2).

“(B) EXCEPTION FOR CERTAIN CIRCUMSTANCES.—The Secretary shall, through rulemaking, specify circumstances and processes by which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of—

“(i) a prescription issued when the practitioner and dispensing pharmacy are the same entity;

“(ii) a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard;

“(iii) a prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner;

“(iv) a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved;

“(v) a prescription issued by a practitioner prescribing a drug under a research protocol;

“(vi) 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 prescribing, such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use;

“(vii) a prescription issued by a practitioner—

“(I) for an individual who receives hospice care under this title; and

“(II) that is not covered under the hospice benefit under this title; and

“(viii) a prescription issued by a practitioner for an individual who is—

“(I) a resident of a nursing facility (as defined in section 1919(a)); and

“(II) dually eligible for benefits under this title and title XIX.

“(C) DISPENSING.— (i) Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A).

“(ii) 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 written, oral, or fax prescriptions that are consistent with laws and regulations.

“(iii) Nothing in this paragraph shall be construed as affecting the ability of an individual who is being prescribed a covered part D drug to designate a particular pharmacy to dispense the covered part D drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph.

“(D) ENFORCEMENT.—The Secretary shall, through rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A).”.

(b) Effective date.—The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021.

(c) Update of Biometric Component of Multifactor Authentication.—Not later than 1 year after the date of enactment of this Act, the Attorney General shall update the requirements for the biometric component of multifactor authentication with respect to electronic prescriptions of controlled substances.

Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)) is amended—

(1) in paragraph (1), by inserting after subparagraph (E) the following new subparagraph:

“(F) With respect to plan years beginning on or after January 1, 2022, a drug management program for at-risk beneficiaries described in paragraph (5).”; and

(2) in paragraph (5)(A), by inserting “(and for plan years beginning on or after January 1, 2022, a PDP sponsor shall)” after “A PDP sponsor may”.

(a) Coverage.—Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended—

(1) in subparagraph (FF), by striking at the end “and”;

(2) in subparagraph (GG), by inserting at the end “and”; and

(3) by adding at the end the following new subparagraph:

“(HH) opioid use disorder treatment services (as defined in subsection (jjj)).”.

(b) Opioid use disorder treatment services and opioid treatment program defined.—Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection:

“(jjj) Opioid use disorder treatment services; opioid treatment program.—

“(1) 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 disorder, including—

“(A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for use in the treatment of opioid use disorder;

“(B) dispensing and administration of such medications, if applicable;

“(C) substance use counseling by a professional to the extent authorized under State law to furnish such services;

“(D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law);

“(E) toxicology testing, and

“(F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation).

“(2) OPIOID TREATMENT PROGRAM.—The term ‘opioid treatment program’ means an entity that is an opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that—

“(A) is enrolled under section 1866(j);

“(B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program;

“(C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and

“(D) meets such additional conditions as the Secretary may find necessary to ensure—

“(i) the health and safety of individuals being furnished services under such program; and

“(ii) the effective and efficient furnishing of such services.”.

(c) Payment.—

(1) IN GENERAL.—Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended—

(A) by striking “and (BB)” and inserting “(BB)”; and

(B) by inserting before the semicolon at the end the following “, and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary”.

(2) PAYMENT DETERMINATION.—Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

“(w) Opioid use disorder treatment services.—

“(1) IN GENERAL.—The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program.

“(2) CONSIDERATIONS.—The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, 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 55 of title 10 of the United States Code.

“(3) ANNUAL UPDATES.—The Secretary shall provide an update each year to the bundled payment amounts under this subsection.”.

(d) Including opioid treatment programs as Medicare providers.—Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is amended—

(1) in paragraph (1), by striking at the end “and”;

(2) in paragraph (2), by striking the period at the end and inserting “; and”; and

(3) by adding at the end the following new paragraph:

“(3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section).”.

Section 1860D–4(c)(5)(C) of the Social Security Act (42 U.S.C. 1395w–104(c)(5)(C)) is amended—

(1) in clause (i), in the matter preceding subclause (I), by striking “For purposes” and inserting “Except as provided in clause (v), for purposes”; and

(2) by adding at the end the following new clause:

“(v) TREATMENT OF ENROLLEES WITH A HISTORY OF OPIOID-RELATED OVERDOSE.—

“(I) IN GENERAL.—For plan years beginning not later than January 1, 2021, a part D eligible individual who is not an exempted individual described in clause (ii) and who is identified under this clause as a part D eligible individual with a history of opioid-related overdose (as defined by the Secretary) shall be included as a potentially at-risk beneficiary for prescription drug abuse under the drug management program under this paragraph.

“(II) IDENTIFICATION AND NOTICE.—For purposes of this clause, the Secretary shall—

“(aa) identify part D eligible individuals with a history of opioid-related overdose (as so defined); and

“(bb) notify the PDP sponsor of the prescription drug plan in which such an individual is enrolled of such identification.”.

(a) In general.—Section 1860D–4(c)(5) of the Social Security Act (42 U.S.C. 1395ww–10(c)(5)) is amended—

(1) in subparagraph (B), in each of clauses (ii)(III) and (iii)(IV), by striking “and the option of an automatic escalation to external review” and inserting “, including notice that if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution”; and

(2) in subparagraph (E), by striking “and the option” and all that follows and inserting the following: “and if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution.”.

(b) Effective date.—The amendments made by subsection (a) shall apply beginning not later January 1, 2021.

(a) In general.—Section 1860D–12(b) of the Social Security Act (42 U.S.C. 1395w–112(b)) is amended by adding at the end the following new paragraph:

“(7) SUSPENSION OF PAYMENTS PENDING INVESTIGATION OF CREDIBLE ALLEGATIONS OF FRAUD BY PHARMACIES.—

“(A) IN GENERAL.—Section 1862(o)(1) shall apply with respect to a PDP sponsor with a contract under this part, a pharmacy, and payments to such pharmacy under this part in the same manner as such section applies with respect to the Secretary, a provider of services or supplier, and payments to such provider of services or supplier under this title. A PDP sponsor shall notify the Secretary regarding the imposition of any payment suspension pursuant to the previous sentence, such as through the secure internet website portal (or other successor technology) established under section 1859(i).

“(B) RULE OF CONSTRUCTION.—Nothing in this paragraph shall be construed as limiting the authority of a PDP sponsor to conduct postpayment review.”.

(b) Application to MA–PD plans.—Section 1857(f)(3) of the Social Security Act (42 U.S.C. 1395w–27(f)(3)) is amended by adding at the end the following new subparagraph:

“(D) SUSPENSION OF PAYMENTS PENDING INVESTIGATION OF CREDIBLE ALLEGATIONS OF FRAUD BY PHARMACIES.—Section 1860D–12(b)(7).”.

(c) Conforming amendment.—Section 1862(o)(3) of the Social Security Act (42 U.S.C. 1395y(o)(3)) is amended by inserting “, section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)),” after “this subsection”.

(d) Clarification relating to credible allegation of fraud.—Section 1862(o) of the Social Security Act (42 U.S.C. 1395y(o)) is amended by adding at the end the following new paragraph:

“(4) CREDIBLE ALLEGATION OF FRAUD.—In carrying out this subsection, section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for a credible allegation of fraud.”.

(e) Effective date.—The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2020.

(a) Public meetings.—Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction, which may include—

(1) the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable;

(2) the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for the development of non-addictive medical products intended to treat pain or addiction;

(3) the evidentiary standards and the development of opioid-sparing data for inclusion in the labeling of medical products intended to treat acute or chronic pain; and

(4) the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive medical products intended to treat pain or addiction.

(b) Guidance.—Not less than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding—

(1) how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary—

(A) may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction;

(B) considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and

(C) considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition;

(2) the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence;

(3) the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain, including—

(A) alternative data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), including patient registries and patient reported outcomes, as appropriate, to support product labeling;

(B) ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid-sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit;

(C) endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use;

(D) best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and

(E) the appropriate format in which to submit such data results to the Secretary; and

(4) the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section.

(c) Definitions.—In this section—

(1) the term “medical product” means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and

(2) the term “opioid-sparing” means reducing, replacing, or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain.

(a) Guidelines.—The Commissioner of Food and Drugs shall develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain only for the relevant therapeutic areas where such guidelines do not exist.

(b) Public input.—In developing the guidelines under subsection (a), the Commissioner of Food and Drugs shall—

(1) consult with stakeholders, which may include conducting a public meeting of medical professional societies (including any State-based societies), health care providers, State medical boards, medical specialties including pain medicine specialty societies, patient groups, pharmacists, academic or medical research entities, and other entities with experience in health care, as appropriate;

(2) collaborate with the Director of the Centers for Disease Control and Prevention, as applicable and appropriate, and other Federal agencies with relevant expertise as appropriate; and

(3) provide for a notice and comment period consistent with section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)) for the submission of comments by the public.

(c) Report.—Not later than 1 year after the date of enactment of this Act, or, if earlier, at the time the guidelines under subsection (a) are finalized, the Commissioner of Food and Drugs shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and post on the public website of the Food and Drug Administration, a report on how the Food and Drug Administration will utilize the guidelines under subsection (a) to protect the public health and a description of the public health need with respect to each such indication-specific treatment guideline.

(d) Updates.—The Commissioner of Food and Drugs shall periodically—

(1) update the guidelines under subsection (a), informed by public input described in subsection (b); and

(2) submit to the committees specified in subsection (c) and post on the public website of the Food and Drug Administration an updated report under such subsection.

(e) Statement To accompany guidelines and recommendations.—The Commissioner of Food and Drugs shall ensure that opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations, as applicable—

(1) are intended to help inform clinical decisionmaking by prescribers and patients; and

(2) are not intended to be used for the purposes of restricting, limiting, delaying, or denying coverage for, or access to, a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.

This chapter may be cited as the “Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act” or the “SCREEN Act”.

(a) Prohibited Acts.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

“(eee) The failure to comply with any order issued under section 569D.”.

(b) Notification, nondistribution, and recall of controlled substances.—Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following:

(c) Controlled substances subject to refusal.—The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by inserting “, or is a controlled substance subject to an order under section 569D” before “, or (4)”.

(d) Effective date.—Sections 301(eee) and 569D of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall be effective beginning on the date of enactment of this Act.

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as amended by section 3012, is further amended by adding at the end the following:

“(t) Single source pattern of imported illegal drugs.—If the Secretary determines that a person subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or drugs as described in section 306(b)(3)(D), and such pattern is identified by the Secretary as being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order determine all drugs being offered for import from such person as adulterated or misbranded, unless such person can provide evidence otherwise.”.

(a) In general.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will provide improvements to such facilities, technologies, and inspection capacity. Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection.

(b) FDA import facilities and inspection capacity.—

(1) IN GENERAL.—In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include—

(A) facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate—

(i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies;

(ii) improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction;

(iii) the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods;

(iv) upgrades to the security of import facilities; and

(v) innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and

(B) innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate.

(2) INNOVATIVE TECHNOLOGY.—Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate and practicable.

(c) Report.—Not later than 6 months after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate on the implementation of this section, including a summary of progress made toward near-real-time information sharing and the interoperability of such technologies.

This chapter may be cited as the “Stop Illicit Drug Importation Act of 2018”.

(a) Food and Drug Administration and U.S. Customs and Border Protection Cooperation.—

(1) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs and in consultation with the U.S. Customs and Border Protection, shall develop and periodically update a mutually agreed upon list of the controlled substances that the Secretary will refer to U.S. Customs and Border Protection, unless the Secretary and U.S. Customs and Border Protection agree otherwise, when such substances are offered for import via international mail and appear to violate the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law. The Secretary shall transfer controlled substances on such list to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.).

(2) REPORT.—Not later than 9 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Secretary of Homeland Security, shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the implementation of this section.

(b) Debarment, temporary denial of approval, and suspension.—

(1) PROHIBITED ACT.—Section 301(cc) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended—

(A) by inserting “or a drug” after “food”; and

(B) by inserting “from such activity” after “person debarred”.

(2) DEBARMENT.—Section 306(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is amended—

(A) in paragraph (1)—

(i) in the matter preceding subparagraph (A), by inserting “or (3)” after “paragraph (2)”;

(ii) in subparagraph (A), by striking the comma at the end and inserting a semicolon;

(iii) in subparagraph (B), by striking “, or” and inserting a semicolon;

(iv) in subparagraph (C), by striking the period and inserting “; or”; and

(v) by adding at the end the following:

“(D) a person from importing or offering for import into the United States a drug.”;

(B) in paragraph (3)—

(i) in the heading, by inserting “or drug” after “Food”;

(ii) in subparagraph (A), by striking “; or” and inserting a semicolon;

(iii) in subparagraph (B), by striking the period and inserting a semicolon; and

(iv) by adding at the end the following:

“(C) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act);

“(D) the person has engaged in a pattern of importing or offering for import—

“(i) controlled substances that are prohibited from importation under section 401(m) of the Tariff Act of 1930 (19 U.S.C. 1401(m)); or

“(ii) adulterated or misbranded drugs that are—

“(I) not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or

“(II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary.”; and

(C) by adding at the end the following:

“(5) DEFINITION.—For purposes of paragraph (3)(D), the term ‘pattern of importing or offering for import’ means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.”.

(c) Imports and exports.—Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended, is further amended—

(1) by striking “, then such article shall be refused admission” inserting “or (5) such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses (1) through (5) shall be refused admission”;

(2) by inserting “If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission.” before “With respect to an article of food, if importation”; and

(3) by striking “Clause (2) of the third sentence” and all that follows through the period at the end and inserting the following: “Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act.”.

(d) Certain illicit articles.—Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is amended by adding at the end the following—

“(u) Illicit articles containing active pharmaceutical ingredients.—

“(1) IN GENERAL.—For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article—

“(A) is not—

“(i) accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and

“(ii) designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, a dietary supplement, or other product that is regulated under this Act); and

“(B) is an ingredient that presents significant public health concern and is, or contains—

“(i) an active ingredient in a drug—

“(I) that is approved under section 505 or licensed under section 351 of the Public Health Service Act; or

“(II) for which—

“(aa) an investigational use exemption has been authorized under section 505(i) of this Act or section 351(a) of the Public Health Service Act; and

“(bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or

“(ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i).

“(2) EFFECT.—This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1).”.

This chapter may be cited as the “Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018” or the “SOUND Disposal and Packaging Act”.

(a) Deliberate disposal and packaging elements of strategy.—Section 505–1(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(e)) is amended by adding at the end the following:

“(4) PACKAGING AND DISPOSAL.—The Secretary may require a risk evaluation mitigation strategy for a drug for which there is a serious risk of an adverse drug experience described in subparagraph (B) or (C) of subsection (b)(1), taking into consideration the factors described in subparagraphs (C) and (D) of subsection (f)(2) and in consultation with other relevant Federal agencies with authorities over drug disposal packaging, which may include requiring that—

“(A) the drug be made available for dispensing to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or

“(B) the drug be dispensed to certain patients with a safe disposal packaging or safe disposal system for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) if the Secretary determines that such safe disposal packaging or system may mitigate such serious risk and is sufficiently available.”.

(b) Assuring access and minimizing burden.—Section 505–1(f)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f)(2)(C)) is amended—

(1) in clause (i) by striking “and” at the end; and

(2) by adding at the end the following:

“(iii) patients with functional limitations; and”.

(c) Application to abbreviated new drug applications.—Section 505–1(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(i)) is amended—

(1) in paragraph (1)—

(A) by redesignating subparagraph (B) as subparagraph (C); and

(B) inserting after subparagraph (A) the following:

“(B) A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug.”; and

(2) in paragraph (2)—

(A) in subparagraph (A), by striking “and” at the end;

(B) by redesignating subparagraph (B) as subparagraph (C); and

(C) by inserting after subparagraph (A) the following:

“(B) shall permit packaging systems and safe disposal packaging or safe disposal systems that are different from those required for the applicable listed drug under subsection (e)(4); and”.

(d) GAO report.—Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to Congress a report containing—

(1) a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies;

(2) an evaluation of existing reference standards with respect to controlled substance disposal products and packaging technologies, including any such standards established by a standards development organization, and how such standards should be considered in ensuring effectiveness of such products and technologies;

(3) identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act (21 U.S.C. 801 et seq.), are made available to the public and any barriers to the use of such disposal products;

(4) identification of ways in which packaging technologies are made available to the public and any barriers to the use of such technologies;

(5) a description of current Federal oversight, if any, of site-of-use, in-home controlled substance disposal products, including—

(A) identification of the Federal agencies that oversee such products;

(B) identification of the methods of disposal of controlled substances recommended by such agencies for site-of-use, in-home disposal; and

(C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances;

(6) a description of current Federal oversight, if any, of controlled substance packaging technologies, including—

(A) identification of the Federal agencies that oversee such technologies;

(B) identification of the technologies recommended by such agencies, including unit dose packaging, packaging that provides a set duration, and other packaging systems that may mitigate abuse or misuse; and

(C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and

(7) recommendations, as appropriate, on—

(A) whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agency or agencies should be responsible for such oversight and, as applicable, review of such products or technologies; and

(B) whether there are applicable standards that should be considered to ensure the effectiveness of such products.

(a) Definition of adverse drug experience.—Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(b)(1)(E)) is amended by striking “of the drug” and inserting “of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling”.

(b) Safety labeling changes.—Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) is amended—

(1) in subparagraph (A) by—

(A) striking “Safety information” and inserting “Safety or new effectiveness information”; and

(B) by striking “If the Secretary becomes” and all that follows through “in the labeling of the drug” and inserting “If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug”;

(2) in clause (i) of subparagraph (B), by inserting before the semicolon “, or new effectiveness information”;

(3) in subparagraph (C) by striking “safety information” and inserting “safety or new effectiveness information”; and

(4) in subparagraph (E) by striking “safety information” and inserting “safety or new effectiveness information”.

(c) Guidance.—Not less than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance regarding the circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. Such guidance shall also address how the Food and Drug Administration may apply this section and the amendments made thereby with respect to circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials and safety labeling changes related to the use of controlled substances for acute or chronic pain.

(a) Conforming applicable number.—Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to read as follows:

“(II) The applicable number is—

“(aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients;

“(bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations);

“(cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as such terms are defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)); or

“(dd) 275 if the practitioner meets the requirements specified in sections 8.610 through 8.655 of title 42, Code of Federal Regulations (or successor regulations).”.

(b) Eliminating any time limitation for nurse practitioners and physician assistants To become qualifying practitioners.—Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)) is amended—

(1) in subclause (I), by striking “or” at the end; and

(2) by amending subclause (II) to read as follows:

“(II) a qualifying other practitioner, as defined in clause (iv), who is a nurse practitioner or physician assistant; or”.

(c) Imposing a time limitation for clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwifes To become qualifying practitioners.—Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)), as amended by subsection (b), is further amended by adding at the end the following:

“(III) for the period beginning on October 1, 2018, and ending on October 1, 2023, a qualifying other practitioner, as defined in clause (iv), who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife.”.

(d) Definition of qualifying other practitioner.—Section 303(g)(2)(G)(iv) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iv)) is amended by striking “nurse practitioner or physician assistant” each place it appears and inserting “nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant”.

(e) Report by Secretary.—Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration, shall submit to Congress a report that assesses the care provided by qualifying practitioners (as defined in section 303(g)(2)(G)(iii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iii))) who are treating, in the case of physicians, more than 100 patients, and in the case of qualifying practitioners who are not physicians, more than 30 patients. Such report shall include recommendations on future applicable patient number levels and limits. In preparing such report, the Secretary shall study, with respect to opioid use disorder treatment—

(1) the average frequency with which qualifying practitioners see their patients;

(2) the average frequency with which patients receive counseling, including the rates by which such counseling is provided by such a qualifying practitioner directly, or by referral;

(3) the frequency of toxicology testing, including the average frequency with which random toxicology testing is administered;

(4) the average monthly patient caseload for each type of qualifying practitioner;

(5) the treatment retention rates for patients;

(6) overdose and mortality rates; and

(7) any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner.

(a) Waivers for Maintenance Treatment or Detoxification.—Section 303(g)(2)(G)(ii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(ii)) is amended by adding at the end the following:

“(VIII) The physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits to the Secretary a written notification under subparagraph (B) and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that—

“(aa) included not less than 8 hours of training on treating and managing opioid-dependent patients; and

“(bb) included, at a minimum—

“(AA) the training described in items (aa) through (gg) of subclause (IV); and

“(BB) training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives.”.

(b) Treatment for children.—The Secretary of Health and Human Services shall consider ways to ensure that an adequate number of qualified practitioners, as defined in subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)), who have a specialty in pediatrics or the treatment of children or adolescents, are granted a waiver under such section 303(g)(2) to treat children and adolescents with substance use disorders.

(c) Technical Amendment.—Section 102(24) of the Controlled Substances Act (21 U.S.C. 802(24)) is amended by striking “Health, Education, and Welfare” and inserting “Health and Human Services”.

(a) In general.—The Secretary of Health and Human Services shall establish a grant program under which the Secretary may make grants to accredited schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the requirements under subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act, as added by section 3202(a) of this Act.

(b) Authorization of appropriations.—There is authorized to be appropriated, for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023.

(a) In general.—The Controlled Substances Act is amended by inserting after section 309 (21 U.S.C. 829) the following:

(b) Study and report.—Not later than 2 years after the date of enactment of this section, the Comptroller General of the United States shall conduct a study and submit to Congress a report on access to and potential diversion of controlled substances administered by injection or implantation.

(c) Technical and conforming amendment.—The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting after the item relating to section 309 the following:

“Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner.”.

This chapter may be cited as the “Empowering Pharmacists in the Fight Against Opioid Abuse Act”.

(a) In general.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate, as appropriate, materials for pharmacists, health care providers, and patients on—

(1) circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act (21 U.S.C. 829) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and

(2) other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances.

(b) Materials included.—In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for—

(1) pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and

(2) other health care practitioners and the public on a pharmacist’s ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)).

(c) Stakeholder input.—In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, including individuals with chronic pain.

This chapter may be cited as the “Safe Disposal of Unused Medication Act”.

(a) In general.—Subsection (g) of section 302 of the Controlled Substances Act (21 U.S.C. 822) is amended by adding at the end the following:

“(5) (A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law and—

“(i) the disposal occurs after the death of a person receiving hospice care;

“(ii) the controlled substance is expired; or

“(iii) (I) the employee is—

“(aa) the physician of the person receiving hospice care; and

“(bb) registered under section 303(f); and

“(II) the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified.

“(B) For the purposes of this paragraph:

“(i) The terms ‘hospice care’ and ‘hospice program’ have the meanings given to those terms in section 1861(dd) of the Social Security Act.

“(ii) The term ‘employee of a qualified hospice program’ means a physician, physician assistant, nurse, or other person who—

“(I) is employed by, or pursuant to arrangements made by, a qualified hospice program;

“(II) (aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and

“(bb) is acting within the scope of such employment in accordance with applicable State law; and

“(III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion.

“(iii) The term ‘qualified hospice program’ means a hospice program that—

“(I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person’s death;

“(II) at the time when the controlled substances are first ordered—

“(aa) provides a copy of the written policies and procedures to the patient or patient representative and family;

“(bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and

“(cc) documents in the patient’s clinical record that the written policies and procedures were provided and discussed; and

“(III) at the time following the disposal of the controlled substances—

“(aa) documents in the patient’s clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and

“(bb) the time, date, and manner in which that disposal occurred.”.

(b) Guidance.—The Attorney General may issue guidance to hospice programs (as defined in paragraph (5) of section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)), as added by subsection (a)) to assist the programs in satisfying the requirements under such paragraph (5).

(c) Rule of construction relating to State and local law.—Nothing in this section or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs.

(a) Study.—

(1) IN GENERAL.—The Comptroller General of the United States (in this section referred to as the “Comptroller General”) shall conduct a study on the requirements applicable to, and challenges of, hospice programs with regard to the management and disposal of controlled substances in the home of an individual.

(2) CONTENTS.—In conducting the study under paragraph (1), the Comptroller General shall include—

(A) an overview of any challenges encountered by selected hospice programs regarding the disposal of controlled substances, such as opioids, in a home setting, including any key changes in policies, procedures, or best practices for the disposal of controlled substances over time; and

(B) a description of Federal requirements, including requirements under the Medicare program, for hospice programs regarding the disposal of controlled substances in a home setting, and oversight of compliance with those requirements.

(b) Report.—Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations, if any, for such legislation and administrative action as the Comptroller General determines appropriate.

This chapter may be cited as the “Special Registration for Telemedicine Clarification Act of 2018”.

Section 311(h)(2) of the Controlled Substances Act (21 U.S.C. 831(h)(2)) is amended to read as follows:

“(2) REGULATIONS.—Not later than 1 year after the date of enactment of the SUPPORT for Patients and Communities Act, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying—

“(A) the limited circumstances in which a special registration under this subsection may be issued; and

“(B) the procedure for obtaining a special registration under this subsection.”.

Section 203 of the Controlled Substances Act (21 U.S.C. 813) is amended—

(1) by striking “A controlled” and inserting “(a) In general.—A controlled”; and

(2) by adding at the end the following:

“(b) Determination.—In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors:

“(1) The marketing, advertising, and labeling of the substance.

“(2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose.

“(3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold.

“(4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance.

“(5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means.

“(6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws.

“(c) Limitation.—For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption.”.

This chapter may be cited as the “Access to Increased Drug Disposal Act of 2018”.

In this chapter—

(1) the term “Attorney General” means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs;

(2) the term “authorized collector” means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation);

(3) the term “covered grant” means a grant awarded under section 3003; and

(4) the term “eligible collector” means a person who is eligible to be an authorized collector.

The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors.

A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum—

(1) identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant;

(2) details a plan to increase participation rates of eligible collectors as authorized collectors; and

(3) describes how the State will select eligible collectors to be served under the grant.

A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors.

The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General.

The Attorney General shall determine the period of years for which a covered grant is made to a State.

A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that—

(1) lists the ultimate recipients of the grant amounts;

(2) describes the activities undertaken by the State using the grant amounts; and

(3) contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors.

The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act.

There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this chapter.

This chapter may be cited as the “Using Data To Prevent Opioid Diversion Act of 2018”.

(a) In general.—The purpose of this chapter is to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates.

(b) Rule of construction.—Nothing in this chapter should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Administration registrant from the responsibility of the manufacturer, distributor, or other registrant to—

(1) identify, stop, and report suspicious orders; or

(2) maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (21 U.S.C. 823) or any successor law or associated regulation.

(a) Records and reports of registrants.—Section 307 of the Controlled Substances Act (21 U.S.C. 827) is amended—

(1) by redesignating subsections (f), (g), and (h) as subsections (g), (h), and (i), respectively;

(2) by inserting after subsection (e) the following:

“(f) (1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances:

“(A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant.

“(B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A).

“(2) The information required to be made available under paragraph (1) shall be made available not later than the 30th day of the first month following the quarter to which the information relates.

“(3) (A) All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection.

“(B) In determining whether to initiate proceedings under this title against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this title or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant.”; and

(3) by inserting after subsection (i), as so redesignated, the following:

“(j) All of the reports required under this section shall be provided in an electronic format.”.

(b) Cooperative arrangements.—Section 503 of the Controlled Substances Act (21 U.S.C. 873) is amended by striking subsection (c) and inserting the following:

“(c) (1) The Attorney General shall, once every 6 months, prepare and make available to regulatory, licensing, attorneys general, and law enforcement agencies of States a standardized report containing descriptive and analytic information on the actual distribution patterns, as gathered through the Automated Reports and Consolidated Orders System, or any subsequent automated system, pursuant to section 307 and which includes detailed amounts, outliers, and trends of distributor and pharmacy registrants, in such States for the controlled substances contained in schedule II, which, in the discretion of the Attorney General, are determined to have the highest abuse.

“(2) If the Attorney General publishes the report described in paragraph (1) once every 6 months as required under paragraph (1), nothing in this subsection shall be construed to bring an action in any court to challenge the sufficiency of the information or to compel the Attorney General to produce any documents or reports referred to in this subsection.”.

(c) Civil and criminal penalties.—Section 402 of the Controlled Substances Act (21 U.S.C. 842) is amended—

(1) in subsection (a)—

(A) in paragraph (15), by striking “or” at the end;

(B) in paragraph (16), by striking the period at the end and inserting “; or”; and

(C) by inserting after paragraph (16) the following:

“(17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 307(f).”; and

(2) in subsection (c)—

(A) in paragraph (1), by striking subparagraph (B) and inserting the following:

“(B) (i) Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the civil penalty shall not exceed $10,000.

“(ii) In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the penalty shall not exceed $100,000.”; and

(B) in paragraph (2)—

(i) in subparagraph (A), by inserting “or (D)” after “subparagraph (B)”; and

(ii) by adding at the end the following:

“(D) In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the criminal fine under title 18, United States Code, shall not exceed $500,000.”.

Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report that provides information about how the Attorney General is using data in the Automation of Reports and Consolidated Orders System to identify and stop suspicious activity, including whether the Attorney General is looking at aggregate orders from individual pharmacies to multiple distributors that in total are suspicious, even if no individual order rises to the level of a suspicious order to a given distributor.

This chapter may be cited as the “Opioid Quota Reform Act”.

(a) In general.—Section 306 of the Controlled Substances Act (21 U.S.C. 826) is amended—

(1) in subsection (a)—

(A) by inserting “(1)” after “(a)”;

(B) in the second sentence, by striking “Production” and inserting “Except as provided in paragraph (2), production”; and

(C) by adding at the end the following:

“(2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance.”;

(2) in subsection (b), in the first sentence, by striking “production” and inserting “manufacturing”;

(3) in subsection (c), by striking “October” and inserting “December”; and

(4) by adding at the end the following:

“(i) (1) (A) In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a ‘covered controlled substance’), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States.

“(B) In estimating diversion under this paragraph, the Attorney General—

“(i) shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and

“(ii) may take into consideration whatever other sources of information the Attorney General determines reliable.

“(C) After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered.

“(2) (A) For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States.

“(B) Not later than 1 year after the date of enactment of this subsection, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance:

“(i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance.

“(ii) An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year.

“(3) Not later than 1 year after the date of enactment of this subsection, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will—

“(A) take into consideration changes in the accepted medical use of the covered controlled substances; and

“(B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events.”.

(b) Conforming change.—The Law Revision Counsel is directed to amend the heading for subsection (b) of section 826 of title 21, United States Code, by striking “production” and inserting “manufacturing”.

This chapter may be cited as the “Preventing Drug Diversion Act of 2018”.

(a) Definition.—Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended by adding at the end the following:

“(57) The term ‘suspicious order’ may include, but is not limited to—

“(A) an order of a controlled substance of unusual size;

“(B) an order of a controlled substance deviating substantially from a normal pattern; and

“(C) orders of controlled substances of unusual frequency.”.

(b) Suspicious orders.—Part C of the Controlled Substances Act (21 U.S.C. 821 et seq.) is amended by adding at the end the following:

(c) Reports to Congress.—

(1) DEFINITION.—In this subsection, the term “suspicious order” has the meaning given that term in section 102 of the Controlled Substances Act, as amended by this chapter.

(2) ONE-TIME REPORT.—Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report on the reporting of suspicious orders, which shall include—

(A) a description of the centralized database established under section 312 of the Controlled Substances Act, as added by this section, to collect reports of suspicious orders;

(B) a description of the system and reports established under section 312 of the Controlled Substances Act, as added by this section, to share information with States;

(C) information regarding how the Attorney General used reports of suspicious orders before the date of enactment of this Act and after the date of enactment of this Act, including how the Attorney General received the reports and what actions were taken in response to the reports; and

(D) descriptions of the data analyses conducted on reports of suspicious orders to identify, analyze, and stop suspicious activity.

(3) ADDITIONAL REPORTS.—Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date that is 5 years after the date of enactment of this Act, the Attorney General shall submit to Congress a report providing, for the previous year—

(A) the number of reports of suspicious orders;

(B) a summary of actions taken in response to reports, in the aggregate, of suspicious orders; and

(C) a description of the information shared with States based on reports of suspicious orders.

(4) ONE-TIME GAO REPORT.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States, in consultation with the Administrator of the Drug Enforcement Administration, shall submit to Congress a report on the reporting of suspicious orders, which shall include an evaluation of the utility of real-time reporting of potential suspicious orders of opioids on a national level using computerized algorithms, including the extent to which such algorithms—

(A) would help ensure that potentially suspicious orders are more accurately captured, identified, and reported in real time to suppliers before orders are filled;

(B) may produce false positives of suspicious order reports that could result in market disruptions for legitimate orders of opioids; and

(C) would reduce the overall length of an investigation that prevents the diversion of suspicious orders of opioids.

Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), as amended by sections 1013 and 1016, is further amended by adding at the end the following new paragraph:

“(9) (A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y).

“(B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State—

“(i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing—

“(I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is at least 85 percent but not greater than the minimum medical loss ratio (as so defined) that such State applied as of May 31, 2018; or

“(II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and

“(ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio.

“(C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent.

“(D) For purposes of this paragraph:

“(i) The term ‘managed care entity’ means a medicaid managed care organization described in section 1932(a)(1)(B)(i).

“(ii) The term ‘minimum medical loss ratio’ means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan).

“(iii) The term ‘other specified entity’ means—

“(I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and

“(II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation).”.

Clause (i) of section 1862(b)(7)(A) of the Social Security Act (42 U.S.C. 1395y(b)(7)(A)) is amended to read as follows:

“(i) 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—

“(I) a primary plan to the program under this title; or

“(II) for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and”.

(a) In general.—Section 5000A(d)(2)(A) of the Internal Revenue Code of 1986 is amended to read as follows:

“(A) RELIGIOUS CONSCIENCE EXEMPTIONS.—

“(i) IN GENERAL.—Such term shall not include any individual for any month if such individual has in effect an exemption under section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act which certifies that—

“(I) such individual is a member of a recognized religious sect or division thereof which is described in section 1402(g)(1), and is adherent of established tenets or teachings of such sect or division as described in such section; or

“(II) such individual is a member of a religious sect or division thereof which is not described in section 1402(g)(1), who relies solely on a religious method of healing, and for whom the acceptance of medical health services would be inconsistent with the religious beliefs of the individual.

“(ii) SPECIAL RULES.—

“(I) MEDICAL HEALTH SERVICES DEFINED.—For purposes of this subparagraph, the term ‘medical health services’ does not include routine dental, vision and hearing services, midwifery services, vaccinations, necessary medical services provided to children, services required by law or by a third party, and such other services as the Secretary of Health and Human Services may provide in implementing section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act.

“(II) ATTESTATION REQUIRED.—Clause (i)(II) shall apply to an individual for months in a taxable year only if the information provided by the individual under section 1411(b)(5)(A) of such Act includes an attestation that the individual has not received medical health services during the preceding taxable year.”.

(b) Effective date.—The amendment made by subsection (a) shall apply to taxable years beginning after December 31, 2018.

(c) Construction.—Nothing in the amendment made by subsection (a) shall preempt any State law requiring the provision of medical treatment for children, especially those who are seriously ill.

Subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173) is amended—

(1) in section 1111, as amended by section 3(1) of the Patient Right to Know Drug Prices Act—

(A) in the paragraph (3) inserted by such section 3(1), by striking “an application” and inserting “a biosimilar biological product application”;

(B) in the paragraph (4) inserted by such section 3(1), by inserting “application ” before “under section 351(k) of the Public Health Service Act”;

(C) in the paragraph (5) inserted by such section 3(1), by striking “for licensure of a biological product under section 351(k) of the Public Health Service Act” and inserting “under section 351(k) of the Public Health Service Act for licensure of a biological product as biosimilar to, or interchangeable with, a reference product”;

(D) in paragraph (7), as redesignated and amended by such section 3(1), by striking “or under section 351(a) of the Public Health Service Act” and inserting “or the owner, or exclusive licensee, of a patent included in a list provided under section 351(l)(3) of the Public Health Service Act”; and

(E) in the paragraph (12) added by such section 3(1), by striking “means a brand name drug for which a license is in effect under section 351(a)” and inserting “has the meaning given such term in section 351(i)”; and

(2) in section 1112, as amended by section 3(2) of the Patient Right to Know Drug Prices Act—

(A) in subsection (a)—

(i) in paragraph (1), by striking “for which a statement under section 351(l)(3)(B)(ii)(I) of the Public Health Service Act has been provided”;

(ii) in paragraph (2)—

(I) in subparagraph (C)(i), by striking “brand name” and inserting “listed”; and

(II) by amending clause (ii) of subparagraph (C) to read as follows:

“(ii) any of the time periods referred to in section 351(k)(6) of the Public Health Service Act as such period applies to such biosimilar biological product application or to any other biosimilar biological product application based on the same reference product.”;

(B) in subsection (b)—

(i) in the subsection heading, by inserting “or Biosimilar Biological Product Applicant” after “Applicant”;

(ii) in paragraph (1)(B), by striking the first sentence and inserting the following: “A biosimilar biological product applicant that has submitted a biosimilar biological product application that references a reference product and another biosimilar biological product applicant that has submitted a biosimilar biological product application that references the same reference product shall each file the agreement in accordance with subsection (c).”; and

(iii) in paragraph (2)—

(I) by striking “2 generic drug applicants” and inserting “2 or more generic drug applicants”; and

(II) by striking “or an agreement between 2 biosimilar biological product applicants regarding the 1-year period referred to in section 351(k)(6)(A) of the Public Health Service Act as it applies to the biosimilar biological product applications with which the agreement is concerned” and inserting “, an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product”; and

(C) in subsection (c)(2), by inserting “were entered into within 30 days of,” after “condition for,”.

Section 1139B of the Social Security Act (42 U.S.C. 1320b–9b) is amended—

(1) in subsection (b)—

(A) in paragraph (3)—

(i) by striking “Not later than January 1, 2013” and inserting the following:

“(A) VOLUNTARY REPORTING.—Not later than January 1, 2013”; and

(ii) by adding at the end the following:

“(B) MANDATORY REPORTING WITH RESPECT TO BEHAVIORAL HEALTH MEASURES.—Beginning with the State report required under subsection (d)(1) for 2024, the Secretary shall require States to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information, using the standardized format for reporting information and procedures developed under subparagraph (A), regarding the quality of behavioral health care for Medicaid eligible adults.”; and

(B) in paragraph (5), by adding at the end the following new subparagraph:

“(C) BEHAVIORAL HEALTH MEASURES.—Beginning with respect to State reports required under subsection (d)(1) for 2024, the core set of adult health quality measures maintained under this paragraph (and any updates or changes to such measures) shall include behavioral health measures.”; and

(2) in subsection (d)(1)(A)—

(A) by striking “the such plan” and inserting “such plan”; and

(B) by striking “subsection (a)(5)” and inserting “subsection (b)(5) and, beginning with the report for 2024, all behavioral health measures included in the core set of adult health quality measures maintained under such subsection (b)(5) and any updates or changes to such measures (as required under subsection (b)(3))”.

This subtitle may be cited as the “Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations Act” or the “Medicaid IMD ADDITIONAL INFO Act”.

(a) In general.—Not later than January 1, 2020, the Medicaid and CHIP Payment and Access Commission established under section 1900 of the Social Security Act (42 U.S.C. 1396) shall conduct an exploratory study, using data from a representative sample of States, and submit to Congress a report on at least the following information, with respect to services furnished to individuals enrolled under State plans under the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.) (or waivers of such plans) who are patients in institutions for mental diseases and for which payment is made through fee-for-service or managed care arrangements under such State plans (or waivers):

(1) A description of such institutions for mental diseases in each such State, including at a minimum—

(A) the number of such institutions in the State;

(B) the facility type of such institutions in the State; and

(C) any coverage limitations under each such State plan (or waiver) on scope, duration, or frequency of such services.

(2) With respect to each such institution for mental diseases in each such State, a description of—

(A) such services provided at such institution;

(B) the process, including any timeframe, used by such institution to clinically assess and reassess such individuals; and

(C) the discharge process used by such institution, including any care continuum of relevant services or facilities provided or used in such process.

(3) A description of—

(A) any Federal waiver that each such State has for such institutions and the Federal statutory authority for such waiver; and

(B) any other Medicaid funding sources used by each such State for funding such institutions, such as supplemental payments.

(4) A summary of State requirements (such as certification, licensure, and accreditation) applied by each such State to such institutions in order for such institutions to receive payment under the State plan (or waiver) and how each such State determines if such requirements have been met.

(5) A summary of State standards (such as quality standards, clinical standards, and facility standards) that such institutions must meet to receive payment under such State plans (or waivers) and how each such State determines if such standards have been met.

(6) If determined appropriate by the Commission, recommendations for policies and actions by Congress and the Centers for Medicare & Medicaid Services, such as on how State Medicaid programs may improve care and improve standards and including a recommendation for how the Centers for Medicare & Medicaid Services can improve data collection from such programs to address any gaps in information.

(b) Stakeholder input.—In carrying out subsection (a), the Medicaid and CHIP Payment and Access Commission shall seek input from State Medicaid directors and stakeholders, including at a minimum the Substance Abuse and Mental Health Services Administration, Centers for Medicare & Medicaid Services, State Medicaid officials, State mental health authorities, Medicaid beneficiary advocates, health care providers, and Medicaid managed care organizations.

(c) Definitions.—In this section:

(1) REPRESENTATIVE SAMPLE OF STATES.—The term “representative sample of States” means a non-probability sample in which at least two States are selected based on the knowledge and professional judgment of the selector.

(2) STATE.—The term “State” means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States.

(3) INSTITUTION FOR MENTAL DISEASES.—The term “institution for mental diseases” has the meaning given such term in section 435.1010 of title 42, Code of Federal Regulations, or any successor regulation.

This subtitle may be cited as the “CHIP Mental Health and Substance Use Disorder Parity Act”.

(a) In general.—Section 2103(c)(1) of the Social Security Act (42 U.S.C. 1397cc(c)(1)) is amended by adding at the end the following new subparagraph:

“(E) Mental health and substance use disorder services (as defined in paragraph (5)).”.

(b) Mental health and substance use disorder services.—

(1) IN GENERAL.—Section 2103(c) of the Social Security Act (42 U.S.C. 1397cc(c)) is amended—

(A) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (6), (7), (8), and (9), respectively; and

(B) by inserting after paragraph (4) the following new paragraph:

“(5) MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES.—Regardless of the type of coverage elected by a State under subsection (a), child health assistance provided under such coverage for targeted low-income children and, in the case that the State elects to provide pregnancy-related assistance under such coverage pursuant to section 2112, such pregnancy-related assistance for targeted low-income pregnant women (as defined in section 2112(d)) shall—

“(A) include coverage of mental health services (including behavioral health treatment) necessary to prevent, diagnose, and treat a broad range of mental health symptoms and disorders, including substance use disorders; and

“(B) be delivered in a culturally and linguistically appropriate manner.”.

(2) CONFORMING AMENDMENTS.—

(A) Section 2103(a) of the Social Security Act (42 U.S.C. 1397cc(a)) is amended, in the matter before paragraph (1), by striking “paragraphs (5), (6), and (7)” and inserting “paragraphs (5), (6), (7), and (8)”.

(B) Section 2110(a) of the Social Security Act (42 U.S.C. 1397jj(a)) is amended—

(i) in paragraph (18), by striking “substance abuse” each place it appears and inserting “substance use”; and

(ii) in paragraph (19), by striking “substance abuse” and inserting “substance use”.

(C) Section 2110(b)(5)(A)(i) of the Social Security Act (42 U.S.C. 1397jj(b)(5)(A)(i)) is amended by striking “subsection (c)(5)” and inserting “subsection (c)(6)”.

(c) Assuring access to care.—Section 2102(a)(7)(B) of the Social Security Act (42 U.S.C. 1397bb(c)(2)) is amended by striking “section 2103(c)(5)” and inserting “paragraphs (5) and (6) of section 2103(c)”.

(d) Mental health services parity.—Subparagraph (A) of paragraph (7) of section 2103(c) of the Social Security Act (42 U.S.C. 1397cc(c)) (as redesignated by subsection (b)(1)) is amended to read as follows:

“(A) IN GENERAL.—A State child health plan shall ensure that the financial requirements and treatment limitations applicable to mental health and substance use disorder services (as described in paragraph (5)) provided under such plan comply with the requirements of section 2726(a) of the Public Health Service Act in the same manner as such requirements or limitations apply to a group health plan under such section.”.

(e) Effective date.—

(1) IN GENERAL.—Subject to paragraph (2), the amendments made by this section shall take effect with respect to child health assistance provided on or after the date that is 1 year after the date of the enactment of this Act.

(2) EXCEPTION FOR STATE LEGISLATION.—In the case of a State child health plan under title XXI of the Social Security Act (or a waiver of such plan), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan (or waiver) to meet any requirement imposed by the amendments made by this section, the respective plan (or waiver) 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 enactment of this section. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature.

This subtitle may be cited as the “Medicaid Reentry Act”.

(a) Stakeholder group development of best practices; State Medicaid program innovation.—

(1) STAKEHOLDER GROUP BEST PRACTICES.—Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a stakeholder group of representatives of managed care organizations, Medicaid beneficiaries, health care providers, the National Association of Medicaid Directors, and other relevant representatives from local, State, and Federal jail and prison systems to develop best practices (and submit to the Secretary and Congress a report on such best practices) for States—

(A) to ease the health care-related transition of an individual who is an inmate of a public institution from the public institution to the community, including best practices for ensuring continuity of health insurance coverage or coverage under the State Medicaid plan under title XIX of the Social Security Act, as applicable, and relevant social services; and

(B) to carry out, with respect to such an individual, such health care-related transition not later than 30 days after such individual is released from the public institution.

(2) STATE MEDICAID PROGRAM INNOVATION.—The Secretary of Health and Human Services shall work with States on innovative strategies to help individuals who are inmates of public institutions and otherwise eligible for medical assistance under the Medicaid program under title XIX of the Social Security Act transition, with respect to enrollment for medical assistance under such program, seamlessly to the community.

(b) Guidance on innovative service delivery systems demonstration project opportunities.—Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a State Medicaid Director letter, based on best practices developed under subsection (a)(1), regarding opportunities to design demonstration projects under section 1115 of the Social Security Act (42 U.S.C. 1315) to improve care transitions for certain individuals who are soon-to-be former inmates of a public institution and who are otherwise eligible to receive medical assistance under title XIX of such Act, including systems for, with respect to a period (not to exceed 30 days) immediately prior to the day on which such individuals are expected to be released from such institution—

(1) providing assistance and education for enrollment under a State plan under the Medicaid program under title XIX of such Act for such individuals during such period; and

(2) providing health care services for such individuals during such period.

(c) Rule of construction.—Nothing under title XIX of the Social Security Act or any other provision of law precludes a State from reclassifying or suspending (rather than terminating) eligibility of an individual for medical assistance under title XIX of the Social Security Act while such individual is an inmate of a public institution.

This subtitle may be cited as the “Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act” or the “Medicaid PARTNERSHIP Act”.

(a) Requirements under the Medicaid program relating to qualified prescription drug monitoring programs and prescribing certain controlled substances.—Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is amended by inserting after section 1943 the following new section:

(b) Guidance.—Not later than October 1, 2019, the Administrator of the Centers for Medicare & Medicaid Services, in consultation with the Director of the Centers for Disease Control and Prevention, shall issue guidance on best practices on the uses of prescription drug monitoring programs required of prescribers and on protecting the privacy of Medicaid beneficiary information maintained in and accessed through prescription drug monitoring programs.

(c) Development of model State practices.—

(1) IN GENERAL.—Not later than October 1, 2020, the Secretary of Health and Human Services shall develop and publish model practices to assist State Medicaid program operations in identifying and implementing strategies to utilize data-sharing agreements described in the matter following paragraph (2) of section 1944(b) of the Social Security Act, as added by subsection (a), for the following purposes:

(A) Monitoring and preventing fraud, waste, and abuse.

(B) Improving health care for individuals enrolled in a State plan under title XIX of such Act (or under a waiver of such plan) who—

(i) transition in and out of coverage under such title;

(ii) may have sources of health care coverage in addition to coverage under such title; or

(iii) pay for prescription drugs with cash.

(C) Any other purposes specified by the Secretary.

(2) ELEMENTS OF MODEL PRACTICES.—The model practices described in paragraph (1)—

(A) shall include strategies for assisting States in allowing the medical director or pharmacy director (or designees of such a director) of managed care organizations or pharmaceutical benefit managers to access information with respect to all covered individuals served by such managed care organizations or pharmaceutical benefit managers to access as a single data set, in an electronic format; and

(B) shall include any appropriate beneficiary protections and privacy guidelines.

(3) CONSULTATION.—In developing model practices under this subsection, the Secretary shall consult with the National Association of Medicaid Directors, managed care entities (as defined in section 1932(a)(1)(B) of the Social Security Act) with contracts with States pursuant to section 1903(m) of such Act, pharmaceutical benefit managers, physicians and other health care providers, beneficiary advocates, and individuals with expertise in health care technology related to prescription drug monitoring programs and electronic health records.

(d) Report by Comptroller General.—Not later than October 1, 2020, the Comptroller General of the United States shall issue a report examining the operation of prescription drug monitoring programs administered by States, including data security and access standards used by such programs.

This title may be cited as the “Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act” or the “IMD CARE Act”.

(a) In general.—Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), as amended by preceding sections of this Act, is further amended—

(1) in section 1905(a), in the subdivision (B) that follows paragraph (30), by inserting “(except in the case of services provided under a State plan amendment described in section 1915(l))” before the period; and

(2) in section 1915, by adding at the end the following new subsection:

“(l) State plan amendment option to provide medical assistance for certain individuals who are patients in certain institutions for mental diseases.—

“(1) IN GENERAL.—With respect to calendar quarters beginning during the period beginning October 1, 2019, and ending September 30, 2023, a State may elect, through a State plan amendment, to provide medical assistance for items and services furnished to an eligible individual who is a patient in an eligible institution for mental diseases in accordance with the requirements of this subsection.

“(2) PAYMENTS.—Subject to paragraphs (3) and (4), amounts expended under a State plan amendment under paragraph (1) for services described in such paragraph furnished, with respect to a 12-month period, to an eligible individual who is a patient in an eligible institution for mental diseases shall be treated as medical assistance for which payment is made under section 1903(a) but only to the extent that such services are furnished for not more than a period of 30 days (whether or not consecutive) during such 12-month period.

“(3) MAINTENANCE OF EFFORT.—

“(A) IN GENERAL.—As a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall (during the period in which it so furnished such medical assistance through a State plan amendment under this subsection) maintain on an annual basis a level of funding expended by the State (and political subdivisions thereof) other than under this title from non-Federal funds for—

“(i) items and services furnished to eligible individuals who are patients in eligible institutions for mental diseases that is not less than the level of such funding for such items and services for the most recently ended fiscal year as of the date of enactment of this subsection or, if higher, for the most recently ended fiscal year as of the date the State submits a State plan amendment to the Secretary to provide such medical assistance in accordance with this subsection; and

“(ii) items and services (including services described in subparagraph (B)) furnished to eligible individuals in outpatient and community-based settings that is not less than the level of such funding for such items and services for the most recently ended fiscal year as of the date of enactment of this subsection or, if higher, for the most recently ended fiscal year as of the date the State submits a State plan amendment to the Secretary to provide such medical assistance in accordance with this subsection.

“(B) SERVICES DESCRIBED.—For purposes of subparagraph (A)(ii), services described in this subparagraph are the following:

“(i) Outpatient and community-based substance use disorder treatment.

“(ii) Evidence-based recovery and support services.

“(iii) Clinically-directed therapeutic treatment to facilitate recovery skills, relapse prevention, and emotional coping strategies.

“(iv) Outpatient medication-assisted treatment, related therapies, and pharmacology.

“(v) Counseling and clinical monitoring.

“(vi) Outpatient withdrawal management and related treatment designed to alleviate acute emotional, behavioral, cognitive, or biomedical distress resulting from, or occurring with, an individual’s use of alcohol and other drugs.

“(vii) Routine monitoring of medication adherence.

“(viii) Other outpatient and community-based services for the treatment of substance use disorders, as designated by the Secretary.

“(C) STATE REPORTING REQUIREMENT.—

“(i) IN GENERAL.—Prior to approval of a State plan amendment under this subsection, as a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall report to the Secretary, in accordance with the process established by the Secretary under clause (ii), the information deemed necessary by the Secretary under such clause.

“(ii) PROCESS.—Not later than the date that is 8 months after the date of enactment of this subsection, the Secretary shall establish a process for States to report to the Secretary, at such time and in such manner as the Secretary deems appropriate, such information as the Secretary deems necessary to verify a State’s compliance with subparagraph (A).

“(4) ENSURING A CONTINUUM OF SERVICES.—

“(A) IN GENERAL.—As a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall carry out each of the requirements described in subparagraphs (B) through (D).

“(B) NOTIFICATION.—Prior to approval of a State plan amendment under this subsection, the State shall notify the Secretary of how the State will ensure that eligible individuals receive appropriate evidence-based clinical screening prior to being furnished with items and services in an eligible institution for mental diseases, including initial and periodic assessments to determine the appropriate level of care, length of stay, and setting for such care for each individual.

“(C) OUTPATIENT SERVICES; INPATIENT AND RESIDENTIAL SERVICES.—

“(i) OUTPATIENT SERVICES.—The State shall, at a minimum, provide medical assistance for services that could otherwise be covered under the State plan, consistent with each of the following outpatient levels of care:

“(I) Early intervention for individuals who, for a known reason, are at risk of developing substance-related problems and for individuals for whom there is not yet sufficient information to document a diagnosable substance use disorder.

“(II) Outpatient services for less than 9 hours per week for adults, and for less than 6 hours per week for adolescents, for recovery or motivational enhancement therapies and strategies.

“(III) Intensive outpatient services for 9 hours or more per week for adults, and for 6 hours or more per week for adolescents, to treat multidimensional instability.

“(IV) Partial hospitalization services for 20 hours or more per week for adults and adolescents to treat multidimensional instability that does not require 24-hour care.

“(ii) INPATIENT AND RESIDENTIAL SERVICES.—The State shall provide medical assistance for services that could otherwise be covered under the State plan, consistent with at least 2 of the following inpatient and residential levels of care:

“(I) Clinically managed, low-intensity residential services that provide adults and adolescents with 24-hour living support and structure with trained personnel and at least 5 hours of clinical service per week per individual.

“(II) Clinically managed, population-specific, high-intensity residential services that provide adults with 24-hour care with trained counselors to stabilize multidimensional imminent danger along with less intense milieu and group treatment for those with cognitive or other impairments unable to use full active milieu or therapeutic community.

“(III) Clinically managed, medium-intensity residential services for adolescents, and clinically managed, high-intensity residential services for adults, that provide 24-hour care with trained counselors to stabilize multidimensional imminent danger and preparation for outpatient treatment.

“(IV) Medically monitored, high-intensity inpatient services for adolescents, and medically monitored, intensive inpatient services withdrawal management for adults, that provide 24-hour nursing care, make physicians available for significant problems in Dimensions 1, 2, or 3, and provide counseling services 16 hours per day.

“(V) Medically managed, intensive inpatient services for adolescents and adults that provide 24-hour nursing care and daily physician care for severe, unstable problems in Dimensions 1, 2 or 3.

“(D) TRANSITION OF CARE.—In order to ensure an appropriate transition for an eligible individual from receiving care in an eligible institution for mental diseases to receiving care at a lower level of clinical intensity within the continuum of care (including outpatient services), the State shall ensure that—

“(i) a placement in such eligible institution for mental diseases would allow for an eligible individual’s successful transition to the community, considering such factors as proximity to an individual’s support network (such as family members, employment, and counseling and other services near an individual’s residence); and

“(ii) all eligible institutions for mental diseases that furnish items and services to individuals for which medical assistance is provided under the State plan—

“(I) are able to provide care at such lower level of clinical intensity; or

“(II) have an established relationship with another facility or provider that is able to provide care at such lower level of clinical intensity and accepts patients receiving medical assistance under this title under which the eligible institution for mental diseases may arrange for individuals to receive such care from such other facility or provider.

“(5) APPLICATION TO MANAGED CARE.—Payments for, and limitations to, medical assistance furnished in accordance with this subsection shall be in addition to and shall not be construed to limit or supersede the ability of States to make monthly capitation payments to managed care organizations for individuals receiving treatment in institutions for mental diseases in accordance with section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation).

“(6) OTHER MEDICAL ASSISTANCE.—The provision of medical assistance for items and services furnished to an eligible individual who is a patient in an eligible institution for mental diseases in accordance with the requirements of this subsection shall not prohibit Federal financial participation for medical assistance for items or services that are provided to such eligible individual in or away from the eligible institution for mental disease during any period in which the eligible individual is receiving items or services in accordance with this subsection.

“(7) DEFINITIONS.—In this subsection:

“(A) DIMENSIONS 1, 2, OR 3.—The term ‘Dimensions 1, 2, or 3’ has the meaning given that term for purposes of the publication of the American Society of Addiction Medicine entitled ‘The ASAM Criteria: Treatment Criteria for Addictive Substance-Related, and Co-Occurring Conditions, 2013’.

“(B) ELIGIBLE INDIVIDUAL.—The term ‘eligible individual’ means an individual who—

“(i) with respect to a State, is enrolled for medical assistance under the State plan or a waiver of such plan;

“(ii) is at least 21 years of age;

“(iii) has not attained 65 years of age; and

“(iv) has at least 1 substance use disorder.

“(C) ELIGIBLE INSTITUTION FOR MENTAL DISEASES.—The term ‘eligible institution for mental diseases’ means an institution for mental diseases that—

“(i) follows reliable, evidence-based practices; and

“(ii) offers at least 2 forms of medication-assisted treatment for substance use disorders on site, including, in the case of medication-assisted treatment for opioid use disorder, at least 1 antagonist and 1 partial agonist.

“(D) INSTITUTION FOR MENTAL DISEASES.—The term ‘institution for mental diseases’ has the meaning given that term in section 1905(i).”.

(b) Rule of construction.—Nothing in the amendments made by subsection (a) shall be construed as encouraging a State to place an individual in an inpatient or a residential care setting where a home or community-based care setting would be more appropriate for the individual, or as preventing a State from conducting or pursuing a demonstration project under section 1115 of the Social Security Act to improve access to, and the quality of, substance use disorder treatment for eligible populations.

Section 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w–1(b)(1)) is amended by striking “$0” and inserting “$31,000,000”.

Section 1115A(b)(2)(B) of the Social Security Act (42 U.S.C. 1315a(b)(2)(B)) is amended by adding at the end the following new clause:

“(xxv) Providing, for the adoption and use of certified EHR technology (as defined in section 1848(o)(4)) to improve the quality and coordination of care through the electronic documentation and exchange of health information, incentive payments to behavioral health providers (such as psychiatric hospitals (as defined in section 1861(f)), community mental health centers (as defined in section 1861(ff)(3)(B)), hospitals that participate in a State plan under title XIX or a waiver of such plan, treatment facilities that participate in such a State plan or such a waiver, mental health or substance use disorder providers that participate in such a State plan or such a waiver, clinical psychologists (as defined in section 1861(ii)), nurse practitioners (as defined in section 1861(aa)(5)) with respect to the provision of psychiatric services, and clinical social workers (as defined in section 1861(hh)(1))).”.

This subtitle may be cited at the “Abuse Deterrent Access Act of 2018”.

(a) In general.—Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on—

(1) the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in an MA–PD plan under part C of title XVIII of the Social Security Act or a prescription drug plan under part D of such title of such Act, taking into account any barriers preventing such individuals from accessing such formulations under such MA–PD or part D plans, such as cost-sharing tiers, fail-first requirements, the price of such formulations, and prior authorization requirements; and

(2) the effectiveness of abuse-deterrent opioid formulations in preventing opioid abuse or misuse; the impact of the use of abuse-deterrent opioid formulations on the use or abuse of other prescription or illicit opioids (including changes in deaths from such opioids); and other public health consequences of the use of abuse-deterrent opioid formulations, such as an increase in rates of human immunodeficiency virus.

(b) Definition of Abuse-Deterrent opioid formulation.—In this section, the term “abuse-deterrent opioid formulation” means an opioid that is a prodrug or that has certain abuse-deterrent properties, such as physical or chemical barriers, agonist or antagonist combinations, aversion properties, delivery system mechanisms, or other features designed to prevent abuse of such opioid.

(a) In general.—Section 1804 of the Social Security Act (42 U.S.C. 1395b–2) is amended by adding at the end the following new subsection:

“(d) The notice provided under subsection (a) shall include—

“(1) references to educational resources regarding opioid use and pain management;

“(2) a description of categories of alternative, non-opioid pain management treatments covered under this title; and

“(3) a suggestion for the beneficiary to talk to a physician regarding opioid use and pain management.”.

(b) Effective date.—The amendment made by subsection (a) shall apply to notices distributed prior to each Medicare open enrollment period beginning after January 1, 2019.

This subtitle may be cited as the “Opioid Addiction Action Plan Act”.

(a) In general.—Not later than January 1, 2020, the Secretary of Health and Human Services (in this section referred to as the “Secretary”), in collaboration with the Pain Management Best Practices Inter-Agency Task Force convened under section 101(b) of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198), shall develop an action plan as described in subsection (b).

(b) Action plan components.—The action plan shall include a review by the Secretary of Medicare and Medicaid payment and coverage policies that may be viewed as potential obstacles to an effective response to the opioid crisis, and recommendations, as determined appropriate by the Secretary, on the following:

(1) A review of payment and coverage policies under the Medicare program under title XVIII of the Social Security Act and the Medicaid program under title XIX of such Act, including a review of coverage and payment under such programs of all medication-assisted treatment approved by the Food and Drug Administration related to the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse, including in such review, payment under the Medicare prospective payment system for inpatient hospital services under section 1886(d) of such Act (42 U.S.C. 1395ww(d)) and the Medicare prospective payment system for hospital outpatient department services under section 1833(t) of such Act (42 U.S.C. 1395I(t)), to determine whether those payment policies resulted in incentives or disincentives that have contributed to the opioid crisis.

(2) Recommendations for payment and service delivery models to be tested as appropriate by the Center for Medicare and Medicaid Innovation and other federally authorized demonstration projects, including value-based models, that may encourage the use of appropriate medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse.

(3) Recommendations for data collection that could facilitate research and policy-making regarding prevention of opioid use disorder as well as data that would aid the Secretary in making coverage and payment decisions under the Medicare and Medicaid programs related to the access to appropriate opioid dependence treatments.

(4) A review of Medicare and Medicaid beneficiaries’ access to the full range of medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse, including access of beneficiaries residing in rural or medically underserved communities.

(5) A review of payment and coverage policies under the Medicare program and the Medicaid program related to medical devices that are non-opioid based treatments approved by the Food and Drug Administration for the management of acute pain and chronic pain, for monitoring substance use withdrawal and preventing overdoses of controlled substances, and for treating substance use disorder, including barriers to patient access.

(c) Stakeholder meetings.—

(1) IN GENERAL.—Beginning not later than 3 months after the date of the enactment of this section, the Secretary shall convene a public stakeholder meeting to solicit public comment on the components of the action plan described in subsection (b).