[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                 H. R. 6

To provide for opioid use disorder prevention, recovery, and treatment, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 13, 2018

Mr. Walden (for himself, Mr. Pallone, Mr. Brady of Texas, Mr. Neal, Mr. 
 Roe of Tennessee, Mr. Shuster, Ms. Foxx, Mr. Goodlatte, Mr. Walz, Mr. 
  DeFazio, and Mr. Burgess) introduced the following bill; which was 
 referred to the Committee on Energy and Commerce, and in addition to 
the Committees on Ways and Means, and the Judiciary, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
To provide for opioid use disorder prevention, recovery, and treatment, 
                        and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (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 for the Act is as 
follows:

Sec. 1. Short title; table of contents.
       TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS

Sec. 101. At-risk youth Medicaid protection.
Sec. 102. Health Insurance for Former Foster Youth.
Sec. 103. Demonstration project to increase substance use provider 
                            capacity under the Medicaid program.
Sec. 104. Drug management program for at-risk beneficiaries.
Sec. 105. Medicaid drug review and utilization.
Sec. 106. Guidance to improve care for infants with neonatal abstinence 
                            syndrome and their mothers; GAO study on 
                            gaps in Medicaid coverage for pregnant and 
                            postpartum women with substance use 
                            disorder.
Sec. 107. Medicaid health homes for opioid-use-disorder Medicaid 
                            enrollees.
       TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS

Sec. 201. Authority not to apply certain Medicare telehealth 
                            requirements in the case of certain 
                            treatment of a substance use disorder or 
                            co-occurring mental health disorder.
Sec. 202. Encouraging the use of non-opioid analgesics for the 
                            management of post-surgical pain.
Sec. 203. Requiring a review of current opioid prescriptions for 
                            chronic pain and screening for opioid use 
                            disorder to be included in the Welcome to 
                            Medicare initial preventive physical 
                            examination.
Sec. 204. Modification of payment for certain outpatient surgical 
                            services.
Sec. 205. Requiring e-prescribing for coverage of covered part D 
                            controlled substances.
Sec. 206. Requiring prescription drug plan sponsors under Medicare to 
                            establish drug management programs for at-
                            risk beneficiaries.
Sec. 207. Medicare coverage of certain services furnished by opioid 
                            treatment programs.
    TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS

Sec. 301. Clarifying FDA regulation of non-addictive pain and addiction 
                            therapies.
Sec. 302. Surveillance and Testing of Opioids to Prevent Fentanyl 
                            Deaths.
Sec. 303. Allowing for more flexibility with respect to medication-
                            assisted treatment for opioid use 
                            disorders.
                           TITLE IV--OFFSETS

Sec. 401. Promoting value in Medicaid managed care.
Sec. 402. Extending period of application of Medicare secondary payer 
                            rules for individuals with end stage renal 
                            disease.
Sec. 403. Requiring reporting by group health plans of prescription 
                            drug coverage information for purposes of 
                            identifying primary payer situations under 
                            the Medicare program.

       TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS

SEC. 101. AT-RISK YOUTH MEDICAID PROTECTION.

    (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 
        (29) 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 (29) of section 1905(a) of the Social Security 
Act (42 U.S.C. 1396d(a)), 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.

SEC. 102. HEALTH INSURANCE FOR FORMER FOSTER YOUTH.

    (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 one 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.

SEC. 103. DEMONSTRATION PROJECT TO INCREASE SUBSTANCE USE PROVIDER 
              CAPACITY UNDER THE MEDICAID PROGRAM.

    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 section, 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 
                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 
                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 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 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 three years 
                after the date of the enactment of this subsection, the 
                Director of the Agency for Healthcare Research and 
                Quality, on 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.''.

SEC. 104. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.

    (a) In General.--Title XIX of the Social Security Act is amended by 
inserting after section 1927 (42 U.S.C. 1396r-8) the following new 
section:

``SEC. 1927A. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.

    ``(a) In General.--Beginning January 1, 2020, a State shall operate 
a qualified drug management program under which a State may enroll 
certain at-risk beneficiaries identified by the State under the 
program.
    ``(b) Qualified Drug Management Program.--For purposes of this 
section, the term `qualified drug management program' means, with 
respect to a State, a program carried out by the State (including 
through a contract with a pharmacy benefit manager) that provides at 
least for the following:
            ``(1) Identification of at-risk individuals.--Under the 
        program, the State identifies, in accordance with subsection 
        (c), individuals enrolled under the State plan (or waiver of 
        the State plan) who are at-risk beneficiaries.
            ``(2) Elements of program.--
                    ``(A) In general.--Under the program, the State, 
                with respect to each individual identified under 
                paragraph (1) and enrolled under the program under 
                paragraph (5)--
                            ``(i) subject to subparagraphs (B) and (C), 
                        selects at least one, but not more than three, 
                        health care providers and at least one, but not 
                        more than three, pharmacies for each such 
                        individual for purposes of clause (ii), in 
                        accordance with a selection process that takes 
                        into account reasonable factors such as the 
                        individual's previous utilization of items and 
                        services from health care providers and 
                        pharmacies, geographic proximity of the 
                        individual to such health care providers and 
                        pharmacies, access of the individual to health 
                        care, reasonable travel time, information 
                        regarding housing status, and any known 
                        preference of the individual for a certain 
                        health care provider or pharmacy; and
                            ``(ii) requires that any controlled 
                        substance furnished to such individual during 
                        the period for which such individual is 
                        enrolled under the program be prescribed by a 
                        health care provider selected under clause (i) 
                        for such individual and dispensed by a pharmacy 
                        selected under clause (i) for such individual 
                        in order for such controlled substance to be 
                        covered under the State plan (or waiver).
                    ``(B) Beneficiary preference.--In the case of an 
                individual receiving a notice under paragraph (3)(A) of 
                being identified as potentially being an at-risk 
                beneficiary described in such paragraph, such 
                individual may submit, during the 30-day period 
                following receipt of such notice, preferences for which 
                health care providers and pharmacies the individual 
                would prefer the State to select under subparagraph 
                (A). The State shall select or change the selection of 
                health care providers and pharmacies under subparagraph 
                (A) for the individuals based on such preferences, 
                except that in the case that State determines that such 
                selection (or change of selection) of a health care 
                provider or pharmacy under subparagraph (A) is 
                contributing or would contribute to prescription drug 
                abuse or drug diversion by the individual, the State 
                may select or change the selection of health care 
                provider or pharmacy for the individual without regard 
                to the preferences of the individual described in this 
                subparagraph. If the State selects or changes the 
                selection pursuant to the preceding sentence without 
                regard to the preferences of the individual, the State 
                shall provide the individual with at least 30 days 
                written notice of the selection or change of selection 
                and a rationale for the selection or change.
                    ``(C) Treatment of pharmacy with multiple 
                locations.--For purposes of subparagraph (A)(i), in the 
                case of a pharmacy that has multiple locations that 
                share real-time electronic prescription data, all such 
                locations of the pharmacy shall collectively be treated 
                as one pharmacy.
                    ``(D) Treatment of existing ffs drug management 
                programs.--In the case of a patient review and 
                restriction program (as identified in the annual report 
                submitted to the Secretary under section 1927(g)(3)(D)) 
                operated by a State pursuant to section 1915(a)(2) 
                before the date of the enactment of this section, such 
                program shall be treated as a qualified drug management 
                program.
                    ``(E) Reasonable access.--The program shall ensure, 
                including through waiver of elements of the program 
                (including under subparagraph (A)(ii)), reasonable 
                access to health care (including access to health care 
                providers and pharmacies with respect to prescription 
                drugs described in subparagraph (A)) in the case of 
                individuals with multiple residences, 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) Notification to identified individuals.--Under the 
        program, the State provides each individual who is identified 
        under paragraph (1), prior to enrolling such individual under 
        the program, at least one notification of each of the 
        following:
                    ``(A) Notice that the State has identified the 
                individual as potentially being an at-risk beneficiary 
                for abuse or misuse of a controlled substance.
                    ``(B) The name, address, and contact information of 
                each health care provider and pharmacy that may be 
                selected for the individual under paragraph (2)(A).
                    ``(C) Information describing all State and Federal 
                public health resources that are designed to address 
                such abuse or misuse to which the individual has 
                access, including mental health services, substance use 
                disorder and recovery services, and other counseling 
                services.
                    ``(D) Notice of, and information about, the right 
                of the individual to--
                            ``(i) submit preferences of the individual 
                        for health care providers and pharmacies to be 
                        selected under paragraph (2)(A), including as 
                        described in paragraph (2)(B);
                            ``(ii) appeal under paragraph (4)--
                                    ``(I) such identification described 
                                in subparagraph (A); and
                                    ``(II) the selection of health care 
                                providers and pharmacies under 
                                paragraph (2)(A).
                    ``(E) An explanation of the meaning and 
                consequences of the identification of the individual as 
                potentially being an at-risk beneficiary for abuse or 
                misuse of a controlled substance, including an 
                explanation of the program.
                    ``(F) Information, including a contact list and 
                clear instructions, that explain how the individual can 
                contact the appropriate entities administering the 
                program in order to submit preferences described in 
                paragraph (2)(B) and any other communications relating 
                to the program.
            ``(4) Appeals process.--Under the program, the State 
        provides for an appeals process under which, with respect to an 
        individual identified under paragraph (1)--
                    ``(A) such individual may appeal--
                            ``(i) such identification; and
                            ``(ii) the selection of a health care 
                        provider or pharmacy under paragraph (2)(A);
                    ``(B) in the case of an appeal described in 
                subparagraph (A)(ii), the State shall accommodate the 
                health care provider or pharmacy preferred by the 
                individual for selection for purposes of paragraph 
                (2)(A), unless the State determines that a change to 
                the selection of health care provider or pharmacy under 
                such paragraph is contributing or would contribute to 
                prescription drug abuse or drug diversion by the 
                individual;
                    ``(C) such individual is provided a period of not 
                less than 30 days following the date of receipt of the 
                notice described in paragraph (3) to submit such 
                appeal; and
                    ``(D) the State must make a determination with 
                respect to an appeal described in subparagraph (A), and 
                notify the individual of such determination, prior to 
                enrollment of such individual in the program.
            ``(5) Enrollment.--Under the program, the State initially 
        enrolls individuals who are identified under paragraph (1) in 
        the program for a 12-month period--
                    ``(A) in the case of such an individual who does 
                not submit an appeal under paragraph (4) within the 
                period applied by the State pursuant to subparagraph 
                (C) of such paragraph, beginning on the day after the 
                last day of such period; and
                    ``(B) in the case of such an individual who does 
                submit an appeal under paragraph (4) within the period 
                applied by the State pursuant to subparagraph (C) of 
                such paragraph but such appeal is denied, beginning not 
                later than 30 days after the date of such denial.
            ``(6) Notification of health care providers and 
        pharmacies.--Under the program, the State provides to each 
        health care provider and pharmacy selected for an individual 
        under paragraph (2)--
                    ``(A) notification that the individual is an at-
                risk beneficiary enrolled under the program and that 
                the provider or pharmacy has been selected for the 
                individual under paragraph (2);
                    ``(B) information on such program and the role of 
                being so selected; and
                    ``(C) a process through which the provider or 
                pharmacy can submit a concern or complaint with respect 
                to being so selected.
            ``(7) Continuation of enrollment.--Under the program, the 
        State, with respect to an individual enrolled under the 
        program, provides for a process to--
                    ``(A) not later than 30 days before the end of the 
                12-month period for which the individual is so enrolled 
                pursuant to paragraph (5)--
                            ``(i) assess, in accordance with publicly 
                        available evidence-based guidelines, whether or 
                        not such individual should continue to be 
                        enrolled under the program; and
                            ``(ii) notify such individual of the 
                        results of the assessment under clause (i);
                    ``(B) continue, subject to subparagraph (C), 
                enrollment of such individual if such assessment 
                recommends such continuation; and
                    ``(C) appeal the continuation of enrollment in 
                accordance with the appeals process described in 
                paragraph (4).
    ``(c) At-Risk Beneficiary.--
            ``(1) Identification.--For purposes of this section, a 
        State shall identify an individual enrolled under the State 
        plan (or waiver of the State plan) as an at-risk beneficiary if 
        the individual is not an exempted individual described in 
        paragraph (2) and--
                    ``(A) is identified as such an at-risk beneficiary 
                through the use of publicly available evidence-based 
                guidelines that indicate misuse or abuse of a 
                controlled substance; or
                    ``(B) the State received notification from a PDP 
                sponsor or Medicare Advantage organization that such 
                individual was identified as being an at-risk 
                beneficiary for prescription drug abuse for enrollment 
                in a drug management program established by the sponsor 
                or organization pursuant to section 1860D-4(c)(5) and 
                such identification has not been terminated under 
                subparagraph (F) of such section.
            ``(2) Exempted individual described.--For purposes of 
        paragraph (1), an exempted individual described in this 
        paragraph is an individual who--
                    ``(A) is receiving--
                            ``(i) hospice or palliative care; or
                            ``(ii) treatment for cancer;
                    ``(B) 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
                    ``(C) the State elects to treat as an exempted 
                individual for purposes of paragraph (1).
    ``(d) Application of Privacy Rules Clarification.--The Secretary 
shall clarify privacy requirements, including requirements under the 
regulations promulgated pursuant to section 264(c) of the Health 
Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 
note), related to the sharing of data under subsection (b)(6) in the 
same manner as the Secretary is required under subparagraph (J) of 
section 1860D-4(c)(5) to clarify privacy requirements related to the 
sharing of data described in such subparagraph.
    ``(e) Reports.--
            ``(1) Annual reports.--A State operating a qualified drug 
        management program shall include in the annual report submitted 
        to the Secretary under section 1927(g)(3)(D), beginning with 
        such reports submitted for 2021, the following information:
                    ``(A) The number of individuals enrolled under the 
                State plan (or waiver of the State plan) who are 
                enrolled under the program and the percentage of 
                individuals enrolled under the State plan (or waiver) 
                who are enrolled under such program.
                    ``(B) The number of prescriptions for controlled 
                substances that were dispensed per month during each 
                such year per individual enrolled under the program, 
                including the daily morphine milligram equivalents and 
                the quantity prescribed for each such prescription.
                    ``(C) The number of pharmacies filling 
                prescriptions for controlled substances for individuals 
                enrolled under such program.
                    ``(D) The number of health care providers writing 
                prescriptions for controlled substances (other than 
                prescriptions for a refill) for individuals enrolled 
                under such program.
                    ``(E) Any other data that the Secretary may 
                require.
                    ``(F) Any report submitted by a managed care entity 
                under subsection (f)(1)(B) with respect to the year 
                involved.
        For each such report for a year after 2021, the information 
        described in this paragraph shall be provided in a manner that 
        compares such information with respect to the prior calendar 
        year to such information with respect to the second prior 
        calendar year.
            ``(2) MACPAC reports and review.--Not later than two years 
        after the date of the enactment of this section, the Medicaid 
        and CHIP Payment and Access Commission (in this section 
        referred to as `MACPAC'), in consultation with the National 
        Association of Medicaid Directors, pharmacy benefit managers, 
        managed care organizations, health care providers (including 
        pharmacists), beneficiary advocates, and other stakeholders, 
        shall publish a report that includes--
                    ``(A) best practices for operating drug management 
                programs, based on a review of a representative sample 
                of States administering such a program;
                    ``(B) a summary of the experience of the appeals 
                process under drug management programs operated by 
                several States, such as the frequency at which 
                individuals appealed the identification of being an at-
                risk individual, the frequency at which individuals 
                appealed the selection of a health care provider or 
                pharmacy under such a program, the timeframes for such 
                appeals, a summary of the reasons for such appeals, and 
                the design of such appeals processes;
                    ``(C) a summary of trends and the effectiveness of 
                qualified drug management programs operated under this 
                section; and
                    ``(D) recommendations to States on how improvements 
                can be made with respect to the operation of such 
                programs.
        In reporting on State practices, the MACPAC shall consider how 
        such programs have been implemented in rural areas, under fee-
        for-service as well as managed care arrangements, and the 
        extent to which such programs have resulted in increased 
        efficiencies to such States or to the Federal Government under 
        this title.
            ``(3) Report on plan for coordinated care.--Not later than 
        January 1, 2021, each State operating a qualified drug 
        management program shall submit to the Administrator of the 
        Centers for Medicare & Medicaid Services a report on how such 
        State plans to provide coordinated care for individuals 
        enrolled under the State plan (or waiver of the State plan) 
        and--
                    ``(A) who are enrolled under the program; or
                    ``(B) who are enrolled with a managed care entity 
                and enrolled under such a qualified drug management 
                program operated by such entity.
    ``(f) Applicability to Managed Care Entities.--
            ``(1) In general.--With respect to any contract that a 
        State enters into on or after January 1, 2020, with a managed 
        care entity (as defined in section 1932(a)(1)(B)) pursuant to 
        section 1903(m), the State shall, as a condition of the 
        contract, require the managed care entity--
                    ``(A) to operate a qualified drug management 
                program (as defined in subsection (b)) for at-risk 
                beneficiaries who are enrolled with such entity and 
                identified by the managed care entity by means of 
                application of paragraph (2);
                    ``(B) to submit to the State an annual report on 
                the matters described in subparagraphs (A) through (E) 
                of subsection (e)(1); and
                    ``(C) to submit to the State a list (and as 
                necessary update such list) of individuals enrolled 
                with such entity under the qualified drug management 
                program operated by such entity under subparagraph (A) 
                for purposes of allowing State plans for which medical 
                assistance is paid on a fee-for-service basis to have 
                access to such information.
            ``(2) Application.--For purposes of applying, with respect 
        to a managed care entity--
                    ``(A) under paragraph (1)(A)--
                            ``(i) the definition of the term `qualified 
                        drug management program' under subsection (b), 
                        other than paragraph (2)(D) of such subsection; 
                        and
                            ``(ii) the provisions of paragraphs (1) and 
                        (2) of subsection (c); and
                    ``(B) under paragraph (1)(B), the report 
                requirements described in subparagraphs (A) through (E) 
                of subsection (e)(1);
        each reference in such subsection (b) and paragraphs of 
        subsection (c) to `a State' or `the State' (other than to `a 
        State plan' or `the State plan') shall be deemed a reference to 
        the managed care entity, each reference under such subsection, 
        paragraphs, or subparagraphs to individuals enrolled under the 
        State plan (or waiver of the State plan) shall be deemed a 
        reference to individuals enrolled with such entity, and each 
        reference under such subsection, paragraphs, or subparagraphs 
        to individuals enrolled under the qualified drug management 
        program operated by the State shall be deemed a reference to 
        individuals enrolled under the qualified drug management 
        program operated by the managed care entity.
    ``(g) Controlled Substance Defined.--For purposes of this section, 
the term `controlled substance' means a drug that is included in 
schedule II, III, or IV of section 202(c) of the Controlled Substances 
Act, or any combination thereof, as specified by the State.''.
    (b) Guidance on At-Risk Population Transitioning Between Medicaid 
FFS and Managed Care.--Not later than October 1, 2019, the Secretary of 
Health and Human Services shall issue guidance for State Medicaid 
programs, with respect to individuals who are enrolled under a State 
plan (or waiver of such plan) under title XIX of the Social Security 
Act and under a drug management program, for purposes of providing best 
practices--
            (1) for transitioning, as applicable, such individuals from 
        fee-for-service Medicaid (and such a program operated by the 
        State) to receiving medical assistance under such title through 
        a managed care entity (as defined in section 1932(a)(1)(B) of 
        the Social Security Act) with a contract that with the State 
        pursuant to section 1903(m) of such Act (and such a program 
        operated by such entity); and
            (2) for transitioning, as applicable, such individuals from 
        receiving medical assistance under such title through a managed 
        care entity (as defined in section 1932(a)(1)(B) of the Social 
        Security Act) with a contract that with the State pursuant to 
        section 1903(m) of such Act (and such a program operated by 
        such entity) to fee-for-service Medicaid (and such a program 
        operated by the State).
    (c) Guidance on At-Risk Population Transitioning to Medicare.--
            (1) In general.--Not later than January 1, 2020, the 
        Secretary of Health and Human Services, after consultation with 
        the Federal Coordinated Health Care Office established under 
        section 2602 of the Patient Protection and Affordable Care Act 
        (42 U.S.C. 1315b), shall issue guidance for State Medicaid 
        programs, with respect to transitioning individuals, providing 
        for--
                    (A) notification to be submitted by the State to 
                the Centers for Medicare & Medicaid Services and such 
                individuals of the status of such individuals as 
                transitioning individuals;
                    (B) notification to such individuals about 
                enrollment under a prescription drug plan under part D 
                of such title or under a MA-PD plan under part C of 
                such title;
                    (C) best practices for transitioning such 
                individuals to such a plan; and
                    (D) best practices for coordination between the 
                qualified drug management program (as described in 
                section 1927A(b) of the Social Security Act, as added 
                by subsection (a)) carried out by the State and a drug 
                management program carried out under such a plan 
                pursuant to section 1860D-4(c)(5) of the Social 
                Security Act (42 U.S.C. 1395w-10(c)(5)).
            (2) Transitioning individuals.--For purposes of paragraph 
        (1), a transitioning individual is an individual who, with 
        respect to a month--
                    (A) is enrolled under the State plan (or waiver of 
                the State plan) and under the qualified drug management 
                program (as described in section 1927A(b) of the Social 
                Security Act, as added by subsection (a)) carried out 
                by the State; and
                    (B) is expected to become eligible for the Medicare 
                program under title XVIII of such Act during the 
                subsequent 12-month period.

SEC. 105. MEDICAID DRUG REVIEW AND UTILIZATION.

    (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 101, 
        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 101, 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 of the 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.

SEC. 106. GUIDANCE TO IMPROVE CARE FOR INFANTS WITH NEONATAL ABSTINENCE 
              SYNDROME AND THEIR MOTHERS; GAO STUDY ON GAPS IN MEDICAID 
              COVERAGE FOR PREGNANT AND POSTPARTUM WOMEN WITH SUBSTANCE 
              USE DISORDER.

    (a) Guidance.--Not later than one 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) the types of services, including post-discharge 
        services and parenting supports, for families of babies with 
        neonatal abstinence syndrome that States may cover under the 
        Medicaid program under title XIX of the Social Security Act;
            (2) best practices from States with respect to innovative 
        or evidenced-based payment models that focus on prevention, 
        screening, treatment, plans of safe care, and post-discharge 
        services for mothers and fathers with substance use disorders 
        and babies with neonatal abstinence syndrome that improve care 
        and clinical outcomes;
            (3) 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; and
            (4) guidance and technical assistance to State Medicaid 
        agencies regarding additional flexibilities and incentives 
        related to screening, prevention, and post-discharge services, 
        including parenting supports.
    (b) GAO Study.--Not later than one 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.

SEC. 107. MEDICAID HEALTH HOMES FOR OPIOID-USE-DISORDER MEDICAID 
              ENROLLEES.

    (a) Extension of Enhanced FMAP for Certain Health Homes for 
Individuals With Substance Use Disorders.--Section 1945 of the Social 
Security Act (42 U.S.C. 1396w-4) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (1), by inserting ``subject to 
                paragraph (4),'' after ``except that,''; and
                    (B) 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.

       TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS

SEC. 201. AUTHORITY NOT TO APPLY CERTAIN MEDICARE TELEHEALTH 
              REQUIREMENTS IN THE CASE OF CERTAIN TREATMENT OF A 
              SUBSTANCE USE DISORDER OR CO-OCCURRING MENTAL HEALTH 
              DISORDER.

    Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is 
amended--
            (1) in paragraph (2)(B)(i), by inserting ``and paragraph 
        (7)(E)'' after ``Subject to clause (ii)''; and
            (2) by adding at the end the following new paragraphs:
            ``(7) Authority not to apply certain requirements in the 
        case of certain treatment of substance use disorder or co-
        occurring mental health disorder.--
                    ``(A) In general.--For purposes of payment under 
                this subsection, in the case of telehealth services 
                described in subparagraph (C) furnished on or after 
                January 1, 2020, to an eligible beneficiary (as defined 
                in subparagraph (F)) for the treatment of a substance 
                use disorder or a mental health disorder that is co-
                occurring with a substance use disorder, the Secretary 
                is authorized to, through rulemaking, not apply any of 
                the requirements described in subparagraph (B).
                    ``(B) Requirements described.--For purposes of this 
                paragraph, the requirements described in this 
                subparagraph are any of the following:
                            ``(i) Qualifications for an originating 
                        site under paragraph (4)(C)(ii).
                            ``(ii) Geographic limitations under 
                        paragraph (4)(C)(i).
                    ``(C) Telehealth services described.--For purposes 
                of this paragraph, the telehealth services described in 
                this subparagraph are services that are both telehealth 
                services and identified by the Secretary, through 
                rulemaking, as services that are the most commonly 
                furnished (as defined by the Secretary) under this part 
                to individuals diagnosed with a substance use disorder 
                or a mental health disorder that is co-occurring with a 
                substance use disorder.
                    ``(D) Clarification.--Nothing in this paragraph 
                shall be construed as limiting or otherwise affecting 
                the authority of the Secretary to limit or eliminate 
                the non-application pursuant to this paragraph of any 
                of the requirements under subparagraph (B).
                    ``(E) Treatment of originating site facility fee.--
                No facility fee shall be paid under paragraph (2)(B) to 
                an originating site with respect to a telehealth 
                service described in subparagraph (B) for which payment 
                is made under this subsection by reason of the non-
                application of a requirement described in subparagraph 
                (B) pursuant to this paragraph if payment for such 
                service would not otherwise be permitted under this 
                subsection if such requirement were applied.
                    ``(F) Eligible beneficiary defined.--For purposes 
                of this paragraph, the term `eligible beneficiary' 
                means an individual who--
                            ``(i) is entitled to, or enrolled for, 
                        benefits under part A and enrolled for benefits 
                        under this part;
                            ``(ii) has a diagnosis for a substance use 
                        disorder; and
                            ``(iii) meets such other criteria as the 
                        Secretary determines appropriate.
                    ``(G) Report.--Not later than 5 years after the 
                date of the enactment of this paragraph, the Secretary 
                shall submit to Congress a report on the impact of any 
                non-application under this paragraph of any of the 
                requirements described in subparagraph (B) on
                            ``(i) the utilization of health care 
                        services related to substance use disorder, 
                        such as behavioral health services and 
                        emergency department visits; and
                            ``(ii) health outcomes related to substance 
                        use disorder, such as substance use overdose 
                        deaths.
                    ``(H) Funding.--For purposes of carrying out this 
                paragraph, 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.
            ``(8) Rule of construction.--Nothing in this subsection may 
        be construed as waiving requirements under this title to comply 
        with applicable State law, including State licensure 
        requirements.''.

SEC. 202. ENCOURAGING THE USE OF NON-OPIOID ANALGESICS FOR THE 
              MANAGEMENT OF POST-SURGICAL PAIN.

    Section 1833(t)(6) of the Social Security Act (42 U.S.C. 
1395l(t)(6)) is amended--
            (1) in subparagraph (C)(i), by inserting ``or, in the case 
        of an eligible non-opioid analgesic (as defined in subparagraph 
        (J)), during a period of 5 years,'' after ``3 years,''; and
            (2) by adding at the end the following new subparagraph:
                    ``(J) Eligible non-opioid analgesic defined.--In 
                this paragraph, the term `eligible non-opioid 
                analgesic' means a drug or biological--
                            ``(i) that is an analgesic that is not an 
                        opioid;
                            ``(ii) that demonstrated substantial 
                        clinical improvement; and
                            ``(iii) for which payment--
                                    ``(I) as an outpatient hospital 
                                service under this part was not being 
                                made as of the date of the enactment of 
                                this subparagraph; or
                                    ``(II) was being made under this 
                                paragraph as of such date.''.

SEC. 203. REQUIRING A REVIEW OF CURRENT OPIOID PRESCRIPTIONS FOR 
              CHRONIC PAIN AND SCREENING FOR OPIOID USE DISORDER TO BE 
              INCLUDED IN THE WELCOME TO MEDICARE INITIAL PREVENTIVE 
              PHYSICAL EXAMINATION.

    (a) In General.--Section 1861(ww) of the Social Security Act (42 
U.S.C. 1395x(ww)) is amended--
            (1) in paragraph (1), by inserting ``and a review of 
        current opioid prescriptions and screening for opioid use 
        disorder (as defined in paragraph (4)),'' before ``but does not 
        include''; and
            (2) by adding at the end the following new paragraph:
    ``(4)(A) For purposes of paragraph (1), the term `a review of 
current opioid prescriptions and screening for opioid use disorder' 
means, with respect to an individual--
            ``(i) a review by a physician or qualified non-physician 
        practitioner of all current prescriptions of the individual; 
        and
            ``(ii) in the case of an individual determined by the 
        review of a physician or qualified non-physician practitioner 
        under subparagraph (A) to have a current prescription for 
        opioids for chronic pain that has been prescribed for a minimum 
        period of time (as specified by the Secretary)--
                    ``(I) a review by the physician or practitioner of 
                the potential risk factors to the individual for opioid 
                use disorder;
                    ``(II) an evaluation by the physician or 
                practitioner of pain of the individual;
                    ``(III) the provision of information regarding non-
                opioid treatment options for the treatment and 
                management of any chronic pain of the individual; and
                    ``(IV) if determined necessary by the physician or 
                practitioner based on the results of the review and 
                evaluation conducted as described in this paragraph, an 
                appropriate referral by the physician or practitioner 
                for additional treatment.
    ``(B) For purposes of this paragraph, the term `qualified non-
physician practitioner' means a physician assistant, nurse 
practitioner, or certified clinical nurse specialist.''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply with respect to initial preventive physical examinations 
furnished on or after January 1, 2020.

SEC. 204. MODIFICATION OF PAYMENT FOR CERTAIN OUTPATIENT SURGICAL 
              SERVICES.

    (a) Freeze of Payment for Certain Services Furnished in Ambulatory 
Surgical Centers.--Section 1833(i)(2) of the Social Security Act (42 
U.S.C. 1395l(i)(2)) is amended by adding at the end the following new 
subparagraph:
            ``(F)(i) With respect to a targeted procedure (as defined 
        in clause (ii)) furnished during 2020 or a subsequent year 
        (before 2024) to an individual in an ambulatory surgical 
        center, the payment amount for such procedure that would 
        otherwise be determined under the revised payment system under 
        subparagraph (D), without application of this subparagraph, 
        shall be equal to the payment amount for such procedure 
        furnished in 2016.
            ``(ii) For purposes of clause (i), the term `targeted 
        procedure' means a procedure to which Healthcare Common 
        Procedure Coding System 62310 (or, for years beginning after 
        2016, 62321), 62311 (or, for years beginning after 2016, 
        62323), 62264, 64490, 64493, or G0260 (or any successor code) 
        applies.
            ``(iii) This subparagraph shall not be applied in a budget-
        neutral manner.''.
    (b) Data Collection.--
            (1) In general.--The Comptroller General shall collect data 
        relating to the cost differential between targeted procedures 
        (as defined in section 1833(i)(2)(F)(ii) of the Social Security 
        Act, as added by subsection (a)) that are performed in a 
        hospital operating room and such procedures that are performed 
        in an office setting within a hospital in order to determine 
        whether such procedures are being properly coded for claims, 
        based on setting, for payment under section 1833(i)(2)(D) of 
        the Social Security Act (42 U.S.C. 1395l(i)(2)(D)) and to 
        determine if further changes are needed in the classification 
        system for covered outpatient department services (as described 
        in section 1833(t)(2)(A) of the Social Security Act (42 U.S.C. 
        1395l(t)(2)(A)).
            (2) Report.--Not later than 4 years after the date of the 
        enactment of this Act, the Comptroller General shall submit a 
        report to the Committee on Energy and Commerce and the 
        Committee on Ways and Means of the House of Representatives and 
        the Committee on Finance of the Senate containing--
                    (A) a determination of whether procedures described 
                in paragraph (1) are being properly coded for claims, 
                based on setting, for payment under section 
                1833(i)(2)(D) of the Social Security Act (42 U.S.C. 
                1395l(i)(2)(D)); and
                    (B) recommendations on any changes the Comptroller 
                General determines are needed in the classification 
                system for covered outpatient department services (as 
                described in section 1833(t)(2)(A) of the Social 
                Security Act (42 U.S.C. 1395l(t)(2)(A)).
    (c) Study.--Not later than 3 years 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 the extent to which procedures 
described in section 1833(i)(2)(F)(ii) of the Social Security Act, as 
added by subsection (a), are effective at preventing the need for 
opioids for individuals furnished such procedures.

SEC. 205. REQUIRING E-PRESCRIBING FOR COVERAGE OF COVERED PART D 
              CONTROLLED SUBSTANCES.

    (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, pursuant to rulemaking, specify 
                circumstances with respect to 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 dispenser 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 has received a waiver or a 
                        renewal thereof for a specified period 
                        determined by the Secretary, not to exceed one 
                        year, from the requirement to use electronic 
                        prescribing, pursuant to a process established 
                        by regulation by the Secretary, 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 allowing for the dispensing of a 
                        non-patient specific prescription pursuant to a 
                        standing order, approved protocol for drug 
                        therapy, collaborative drug management, or 
                        comprehensive medication management, in 
                        response to a public health emergency, or other 
                        circumstances where the practitioner may issue 
                        a non-patient specific prescription;
                            ``(vi) a prescription issued by a 
                        practitioner prescribing a drug under a 
                        research protocol;
                            ``(vii) 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; and
                            ``(viii) a prescription issued by a 
                        practitioner for an individual who--
                                    ``(I) receives hospice care under 
                                this title; or
                                    ``(II) is a resident of a skilled 
                                nursing facility (as defined in section 
                                1819(a)), or a medical institution or 
                                nursing facility for which payment is 
                                made for an institutionalized 
                                individual under section 1902(q)(1)(B), 
                                for which frequently abused drugs are 
                                dispensed for residents through a 
                                contract with a single pharmacy, as 
                                determined by the Secretary in 
                                accordance with this paragraph.
                    ``(C) Dispensing.--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). 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. Nothing in this paragraph 
                shall be construed as affecting the ability of the 
                beneficiary involved to designate a particular pharmacy 
                to dispense a prescribed drug to the extent consistent 
                with the requirements under subsection (b)(1) and under 
                this paragraph.
                    ``(D) Enforcement.--The Secretary shall, pursuant 
                to 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.

SEC. 206. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS UNDER MEDICARE TO 
              ESTABLISH DRUG MANAGEMENT PROGRAMS FOR AT-RISK 
              BENEFICIARIES.

    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, 2021, 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, 2021, a PDP sponsor shall)'' 
        after ``A PDP sponsor may''.

SEC. 207. MEDICARE COVERAGE OF CERTAIN SERVICES FURNISHED BY OPIOID 
              TREATMENT PROGRAMS.

    (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 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 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).''.

    TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS

SEC. 301. CLARIFYING FDA REGULATION OF NON-ADDICTIVE PAIN AND ADDICTION 
              THERAPIES.

    (a) Public Meetings.--Not later than 1 year after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
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 pain or 
addiction, which may include--
            (1) 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; 
        and
            (2) 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 later 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-opioid or 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; 
                and
            (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.
    (c) Medical Product Defined.--In this section, 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))).

SEC. 302. SURVEILLANCE AND TESTING OF OPIOIDS TO PREVENT FENTANYL 
              DEATHS.

    (a) Public Health Laboratories To Detect Fentanyl.--Part F of title 
III of the Public Health Service Act (42 U.S.C. 262 et seq.) is 
amended--
            (1) in the heading of part F, by striking ``and Clinical 
        Laboratories'' and inserting ``, Clinical Laboratories, and 
        Public Health Laboratories''; and
            (2) by adding at the end the following new subpart:

                ``Subpart 4--Public Health Laboratories

``SEC. 355. PUBLIC HEALTH LABORATORIES TO DETECT FENTANYL.

    ``(a) In General.--The Secretary shall establish a program to award 
grants to Federal, State, and local agencies to support the 
establishment or operation of public health laboratories to detect 
fentanyl, its analogues, and other synthetic opioids, as described in 
subsection (b).
    ``(b) Standards.--The Secretary, in consultation with the Director 
of the National Institute of Standards and Technology, shall--
            ``(1) develop standards for safely and effectively handling 
        and testing fentanyl, its analogues, and other synthetic 
        opioids;
            ``(2) develop fentanyl and fentanyl analog reference 
        materials and quality control standards and protocols to 
        calibrate instrumentation for clinical diagnostics and 
        postmortem surveillance; and
            ``(3) include in the standards developed pursuant to 
        paragraph (1) procedures for encountering new and emerging 
        synthetic opioid formulations and reporting those findings to 
        other Federal, State, and local public health laboratories.
    ``(c) Laboratories.--The Secretary shall require grantees under 
subsection (a) to--
            ``(1) follow the standards established under subsection (b) 
        and be capable of providing systematic and routine laboratory 
        testing of drugs for the purposes of obtaining and 
        disseminating public health information to Federal, State, and 
        local public health officials, laboratories, and other entities 
        the Secretary deems appropriate;
            ``(2) work with law enforcement agencies and public health 
        authorities, as feasible, to develop real-time information on 
        the purity and movement of fentanyl, its analogues, and other 
        synthetic opioids;
            ``(3) assist State and local law enforcement agencies in 
        testing seized drugs when State and local forensic laboratories 
        request additional assistance;
            ``(4) provide early warning information and advice to 
        Federal, State, and local law enforcement agencies and public 
        health authorities regarding potential significant changes in 
        the supply of fentanyl, its analogues, and other synthetic 
        opioids;
            ``(5) provide biosurveillance for non-fatal exposures; and
            ``(6) provide diagnostic testing for non-fatal exposures of 
        emergency personnel.
    ``(d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $15,000,000 for each of fiscal 
years 2019 through 2023.''.
    (b) Enhanced Fentanyl Surveillance.--Title III of the Public Health 
Service Act is amended by inserting after section 317T of such Act (42 
U.S.C. 247b-22) the following new section:

``SEC. 317U. ENHANCED FENTANYL SURVEILLANCE.

    ``(a) In General.--The Director of the Centers for Disease Control 
and Prevention shall enhance its drug surveillance program by--
            ``(1) expanding its surveillance program to include all 50 
        States and the territories of the United States;
            ``(2) increasing and accelerating the collection of data on 
        fentanyl, its analogues, and other synthetic opioids and new 
        emerging drugs of abuse, including related overdose data from 
        medical examiners and drug treatment admissions; and
            ``(3) utilizing available and emerging information on 
        fentanyl, its analogues, and other synthetic opioids and new 
        emerging drugs of abuse, including information from--
                    ``(A) the National Drug Early Warning System;
                    ``(B) State and local public health authorities; 
                and
                    ``(C) Federal, State, and local public health 
                laboratories.
    ``(b) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $10,000,000 for each of fiscal 
years 2019 through 2023.''.
    (c) Pilot Program for Point-of-Use Testing of Illicit Drugs for 
Dangerous Contaminants.--Part P of title III of the Public Health 
Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end 
the following new section:

``SEC. 399V-7. PILOT PROGRAM FOR POINT-OF-USE TESTING OF ILLICIT DRUGS 
              FOR DANGEROUS CONTAMINANTS.

    ``(a) In General.--The Secretary shall--
            ``(1) establish a pilot program through which 5 State or 
        local agencies conduct, in 5 States, point-of-use testing of 
        illicit drugs for dangerous contaminants;
            ``(2) establish metrics to evaluate the success of the 
        pilot program in reducing drug overdose rates; and
            ``(3) based on such metrics, conduct an annual evaluation 
        of the pilot program and submit an annual report to the 
        Congress containing the results of such evaluation.
    ``(b) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $5,000,000 for each of fiscal 
years 2019 through 2023.''.

SEC. 303. ALLOWING FOR MORE FLEXIBILITY WITH RESPECT TO MEDICATION-
              ASSISTED TREATMENT FOR OPIOID USE DISORDERS.

    (a) Conforming Applicable Number.--Subclause (II) of section 
303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C. 
823(g)(2)(B)(iii)) is amended to read as follows:
            ``(II) The applicable number is--
                    ``(aa) 100 if, not sooner than 1 year after the 
                date on which the practitioner submitted the initial 
                notification, the practitioner submits a second 
                notification to the Secretary of the need and intent of 
                the practitioner to treat up to 100 patients;
                    ``(bb) 100 if the practitioner holds additional 
                credentialing, as defined in section 8.2 of title 42, 
                Code of Federal Regulations (or successor regulations); 
                or
                    ``(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)).''.
    (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 two 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, 100 or more patients, and in the 
case of qualifying practitioners who are not physicians, 30 or more 
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 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.

                           TITLE IV--OFFSETS

SEC. 401. PROMOTING VALUE IN MEDICAID MANAGED CARE.

    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)(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 2025), 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 equal to 
                or greater than 85 percent; 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).''.

SEC. 402. EXTENDING PERIOD OF APPLICATION OF MEDICARE SECONDARY PAYER 
              RULES FOR INDIVIDUALS WITH END STAGE RENAL DISEASE.

    Section 1862(b)(1)(C) of the Social Security Act (42 U.S.C. 
1395y(b)(1)(C)) is amended--
            (1) in the last sentence, by inserting ``and before January 
        1, 2020'' after ``date of enactment of the Balanced Budget Act 
        of 1997''; and
            (2) by adding at the end the following new sentence: 
        ``Effective for items and services furnished on or after 
        January 1, 2020 (with respect to periods beginning on or after 
        July 1, 2018), clauses (i) and (ii) shall be applied by 
        substituting `33-month' for `12-month' each place it 
        appears.''.

SEC. 403. REQUIRING REPORTING BY GROUP HEALTH PLANS OF PRESCRIPTION 
              DRUG COVERAGE INFORMATION FOR PURPOSES OF IDENTIFYING 
              PRIMARY PAYER SITUATIONS UNDER THE MEDICARE PROGRAM.

    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''.
                                 <all>