[116th Congress Public Law 16]
[From the U.S. Government Publishing Office]



[[Page 851]]

       MEDICAID SERVICES INVESTMENT AND ACCOUNTABILITY ACT OF 2019

[[Page 133 STAT. 852]]

Public Law 116-16
116th Congress

                                 An Act


 
To amend title XIX to extend protection for Medicaid recipients of home 
and community-based services against spousal impoverishment, establish a 
   State Medicaid option to provide coordinated care to children with 
      complex medical conditions through health homes, prevent the 
  misclassification of drugs for purposes of the Medicaid drug rebate 
program, and for other purposes. <<NOTE: Apr. 18, 2019 -  [H.R. 1839]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Medicaid 
Services Investment and Accountability Act of 2019. 42 USC 1305 note.>> 
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicaid Services Investment and 
Accountability Act of 2019''.
SEC. 2. EXTENSION OF PROTECTION FOR MEDICAID RECIPIENTS OF HOME 
                    AND COMMUNITY-BASED SERVICES AGAINST SPOUSAL 
                    IMPOVERISHMENT.

    (a) In General.--Section 2404 of Public Law 111-148 (42 U.S.C. 
1396r-5 note), as amended by section 3(a) of the Medicaid Extenders Act 
of 2019 (Public Law 116-3), is amended by striking ``March 31, 2019'' 
and inserting ``September 30, 2019''.
    (b) <<NOTE: 42 USC 1396r-5 note.>>  Rule of Construction.--
            (1) Protecting state spousal income and asset disregard 
        flexibility under waivers and plan amendments.--Nothing in 
        section 2404 of Public Law 111-148 (42 U.S.C. 1396r-5 note) or 
        section 1924 of the Social Security Act (42 U.S.C. 1396r-5) 
        shall be construed as prohibiting a State from disregarding an 
        individual's spousal income and assets under a State waiver or 
        plan amendment described in paragraph (2) for purposes of making 
        determinations of eligibility for home and community-based 
        services or home and community-based attendant services and 
        supports under such waiver or plan amendment.
            (2) State waiver or plan amendment described.--A State 
        waiver or plan amendment described in this paragraph is any of 
        the following:
                    (A) A waiver or plan amendment to provide medical 
                assistance for home and community-based services under a 
                waiver or plan amendment under subsection (c), (d), or 
                (i) of section 1915 of the Social Security Act (42 
                U.S.C. 1396n) or under section 1115 of such Act (42 
                U.S.C. 1315).
                    (B) A plan amendment to provide medical assistance 
                for home and community-based services for individuals by 
                reason of being determined eligible under section 
                1902(a)(10)(C) of such Act (42 U.S.C. 1396a(a)(10)(C)) 
                or by reason of section 1902(f) of such Act (42 U.S.C. 
                1396a(f))

[[Page 133 STAT. 853]]

                or otherwise on the basis of a reduction of income based 
                on costs incurred for medical or other remedial care 
                under which the State disregarded the income and assets 
                of the individual's spouse in determining the initial 
                and ongoing financial eligibility of an individual for 
                such services in place of the spousal impoverishment 
                provisions applied under section 1924 of such Act (42 
                U.S.C. 1396r-5).
                    (C) A plan amendment to provide medical assistance 
                for home and community-based attendant services and 
                supports under section 1915(k) of such Act (42 U.S.C. 
                1396n(k)).
SEC. 3. STATE OPTION TO PROVIDE COORDINATED CARE THROUGH A HEALTH 
                    HOME FOR CHILDREN WITH MEDICALLY COMPLEX 
                    CONDITIONS.

    Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is 
amended by inserting after section 1945 the following new section:
``SEC. 1945A. <<NOTE: 42 USC 1396w-4a.>>  STATE OPTION TO PROVIDE 
                            COORDINATED CARE THROUGH A HEALTH HOME 
                            FOR CHILDREN WITH MEDICALLY COMPLEX 
                            CONDITIONS.

    ``(a) <<NOTE: Effective date.>>  In General.--Notwithstanding 
section 1902(a)(1) (relating to statewideness) and section 
1902(a)(10)(B) (relating to comparability), beginning October 1, 2022, a 
State, at its option as a State plan amendment, may provide for medical 
assistance under this title to children with medically complex 
conditions who choose to enroll in a health home under this section by 
selecting a designated provider, a team of health care professionals 
operating with such a provider, or a health team as the child's health 
home for purposes of providing the child with health home services.

    ``(b) <<NOTE: Coordination.>>  Health Home Qualification 
Standards.--The Secretary shall establish standards for qualification as 
a health home for purposes of this section. Such standards shall include 
requiring designated providers, teams of health care professionals 
operating with such providers, and health teams to demonstrate to the 
State the ability to do the following:
            ``(1) Coordinate prompt care for children with medically 
        complex conditions, including access to pediatric emergency 
        services at all times.
            ``(2) Develop an individualized comprehensive pediatric 
        family-centered care plan for children with medically complex 
        conditions that accommodates patient preferences.
            ``(3) Work in a culturally and linguistically appropriate 
        manner with the family of a child with medically complex 
        conditions to develop and incorporate into such child's care 
        plan, in a manner consistent with the needs of the child and the 
        choices of the child's family, ongoing home care, community-
        based pediatric primary care, pediatric inpatient care, social 
        support services, and local hospital pediatric emergency care.
            ``(4) Coordinate access to--
                    ``(A) subspecialized pediatric services and programs 
                for children with medically complex conditions, 
                including the most intensive diagnostic, treatment, and 
                critical care levels as medically necessary; and
                    ``(B) palliative services if the State provides such 
                services under the State plan (or a waiver of such 
                plan).
            ``(5) Coordinate care for children with medically complex 
        conditions with out-of-State providers furnishing care to such

[[Page 133 STAT. 854]]

        children to the maximum extent practicable for the families of 
        such children and where medically necessary, in accordance with 
        guidance issued under subsection (e)(1) and section 431.52 of 
        title 42, Code of Federal Regulations.
            ``(6) Collect and report information under subsection 
        (g)(1).

    ``(c) Payments.--
            ``(1) In general.--A State shall provide a designated 
        provider, a team of health care professionals operating with 
        such a provider, or a health team with payments for the 
        provision of health home services to each child with medically 
        complex conditions that selects such provider, team of health 
        care professionals, or health team as the child's health home. 
        Payments made to a designated provider, a team of health care 
        professionals operating with such a provider, or a health team 
        for such services shall be treated as medical assistance for 
        purposes of section 1903(a), except that, during the first 2 
        fiscal year quarters that the State plan amendment is in effect, 
        the Federal medical assistance percentage applicable to such 
        payments shall be increased by 15 percentage points, but in no 
        case may exceed 90 percent.
            ``(2) Methodology.--
                    ``(A) In general.--The State shall specify in the 
                State plan amendment the methodology the State will use 
                for determining payment for the provision of health home 
                services. Such methodology for determining payment--
                          ``(i) may be tiered to reflect, with respect 
                      to each child with medically complex conditions 
                      provided such services by a designated provider, a 
                      team of health care professionals operating with 
                      such a provider, or a health team, the severity or 
                      number of each such child's chronic conditions, 
                      life-threatening illnesses, disabilities, or rare 
                      diseases, or the specific capabilities of the 
                      provider, team of health care professionals, or 
                      health team; and
                          ``(ii) shall be established consistent with 
                      section 1902(a)(30)(A).
                    ``(B) Alternate models of payment.--The methodology 
                for determining payment for provision of health home 
                services under this section shall not be limited to a 
                per-member per-month basis and may provide (as proposed 
                by the State and subject to approval by the Secretary) 
                for alternate models of payment.
            ``(3) Planning grants.--
                    ``(A) <<NOTE: Effective date.>>  In general.--
                Beginning October 1, 2022, the Secretary may award 
                planning grants to States for purposes of developing a 
                State plan amendment under this section. A planning 
                grant awarded to a State under this paragraph shall 
                remain available until expended.
                    ``(B) State contribution.--A State awarded a 
                planning grant shall contribute an amount equal to the 
                State percentage determined under section 1905(b) 
                (without regard to section 5001 of Public Law 111-5) for 
                each fiscal year for which the grant is awarded.
                    ``(C) Limitation.--The total amount of payments made 
                to States under this paragraph shall not exceed 
                $5,000,000.

    ``(d) Coordinating Care.--

[[Page 133 STAT. 855]]

            ``(1) <<NOTE: Procedures.>>  Hospital notification.--A State 
        with a State plan amendment approved under this section shall 
        require each hospital that is a participating provider under the 
        State plan (or a waiver of such plan) to establish procedures 
        for, in the case of a child with medically complex conditions 
        who is enrolled in a health home pursuant to this section and 
        seeks treatment in the emergency department of such hospital, 
        notifying the health home of such child of such treatment.
            ``(2) Education with respect to availability of health home 
        services.--In order for a State plan amendment to be approved 
        under this section, a State shall include in the State plan 
        amendment a description of the State's process for educating 
        providers participating in the State plan (or a waiver of such 
        plan) on the availability of health home services for children 
        with medically complex conditions, including the process by 
        which such providers can refer such children to a designated 
        provider, team of health care professionals operating such a 
        provider, or health team for the purpose of establishing a 
        health home through which such children may receive such 
        services.
            ``(3) Family education.--In order for a State plan amendment 
        to be approved under this section, a State shall include in the 
        State plan amendment a description of the State's process for 
        educating families with children eligible to receive health home 
        services pursuant to this section of the availability of such 
        services. Such process shall include the participation of 
        family-to-family entities or other public or private 
        organizations or entities who provide outreach and information 
        on the availability of health care items and services to 
        families of individuals eligible to receive medical assistance 
        under the State plan (or a waiver of such plan).
            ``(4) <<NOTE: Consultation.>>  Mental health coordination.--
        A State with a State plan amendment approved under this section 
        shall consult and coordinate, as appropriate, with the Secretary 
        in addressing issues regarding the prevention and treatment of 
        mental illness and substance use among children with medically 
        complex conditions receiving health home services under this 
        section.

    ``(e) Guidance on Coordinating Care From Out-of-State Providers.--
            ``(1) <<NOTE: Deadline.>>  In general.--Not later than 
        October 1, 2020, the Secretary shall issue (and update as the 
        Secretary determines necessary) guidance to State Medicaid 
        directors on--
                    ``(A) best practices for using out-of-State 
                providers to provide care to children with medically 
                complex conditions;
                    ``(B) coordinating care for such children provided 
                by such out-of-State providers (including when provided 
                in emergency and non-emergency situations);
                    ``(C) reducing barriers for such children receiving 
                care from such providers in a timely fashion; and
                    ``(D) processes for screening and enrolling such 
                providers in the respective State plan (or a waiver of 
                such plan), including efforts to streamline such 
                processes or reduce the burden of such processes on such 
                providers.
            ``(2) Stakeholder input.--In carrying out paragraph (1), the 
        Secretary shall issue a request for information to seek input 
        from children with medically complex conditions and their 
        families, States, providers (including children's hospitals,

[[Page 133 STAT. 856]]

        hospitals, pediatricians, and other providers), managed care 
        plans, children's health groups, family and beneficiary 
        advocates, and other stakeholders with respect to coordinating 
        the care for such children provided by out-of-State providers.

    ``(f) <<NOTE: Methodologies.>>  Monitoring.--A State shall include 
in the State plan amendment--
            ``(1) a methodology for tracking reductions in inpatient 
        days and reductions in the total cost of care resulting from 
        improved care coordination and management under this section;
            ``(2) <<NOTE: Proposal.>>  a proposal for use of health 
        information technology in providing health home services under 
        this section and improving service delivery and coordination 
        across the care continuum (including the use of wireless patient 
        technology to improve coordination and management of care and 
        patient adherence to recommendations made by their provider); 
        and
            ``(3) a methodology for tracking prompt and timely access to 
        medically necessary care for children with medically complex 
        conditions from out-of-State providers.

    ``(g) Data Collection.--
            ``(1) Provider reporting requirements.--In order to receive 
        payments from a State under subsection (c), a designated 
        provider, a team of health care professionals operating with 
        such a provider, or a health team shall report to the State, at 
        such time and in such form and manner as may be required by the 
        State, the following information:
                    ``(A) With respect to each such provider, team of 
                health care professionals, or health team, the name, 
                National Provider Identification number, address, and 
                specific health care services offered to be provided to 
                children with medically complex conditions who have 
                selected such provider, team of health care 
                professionals, or health team as the health home of such 
                children.
                    ``(B) Information on all applicable measures for 
                determining the quality of health home services provided 
                by such provider, team of health care professionals, or 
                health team, including, to the extent applicable, child 
                health quality measures and measures for centers of 
                excellence for children with complex needs developed 
                under this title, title XXI, and section 1139A.
                    ``(C) Such other information as the Secretary shall 
                specify in guidance.
        When appropriate and feasible, such provider, team of health 
        care professionals, or health team, as the case may be, shall 
        use health information technology in providing the State with 
        such information.
            ``(2) State reporting requirements.--
                    ``(A) Comprehensive report.--A State with a State 
                plan amendment approved under this section shall report 
                to the Secretary (and, upon request, to the Medicaid and 
                CHIP Payment and Access Commission), at such time and in 
                such form and manner determined by the Secretary to be 
                reasonable and minimally burdensome, the following 
                information:
                          ``(i) Information reported under paragraph 
                      (1).
                          ``(ii) The number of children with medically 
                      complex conditions who have selected a health home 
                      pursuant to this section.

[[Page 133 STAT. 857]]

                          ``(iii) The nature, number, and prevalence of 
                      chronic conditions, life-threatening illnesses, 
                      disabilities, or rare diseases that such children 
                      have.
                          ``(iv) The type of delivery systems and 
                      payment models used to provide services to such 
                      children under this section.
                          ``(v) The number and characteristics of 
                      designated providers, teams of health care 
                      professionals operating with such providers, and 
                      health teams selected as health homes pursuant to 
                      this section, including the number and 
                      characteristics of out-of-State providers, teams 
                      of health care professionals operating with such 
                      providers, and health teams who have provided 
                      health care items and services to such children.
                          ``(vi) The extent to which such children 
                      receive health care items and services under the 
                      State plan.
                          ``(vii) Quality measures developed 
                      specifically with respect to health care items and 
                      services provided to children with medically 
                      complex conditions.
                    ``(B) <<NOTE: Public information. Web posting.>>  
                Report on best practices.--Not later than 90 days after 
                a State has a State plan amendment approved under this 
                section, such State shall submit to the Secretary, and 
                make publicly available on the appropriate State 
                website, a report on how the State is implementing 
                guidance issued under subsection (e)(1), including 
                through any best practices adopted by the State.

    ``(h) Rule of Construction.--Nothing in this section may be 
construed--
            ``(1) to require a child with medically complex conditions 
        to enroll in a health home under this section;
            ``(2) to limit the choice of a child with medically complex 
        conditions in selecting a designated provider, team of health 
        care professionals operating with such a provider, or health 
        team that meets the health home qualification standards 
        established under subsection (b) as the child's health home; or
            ``(3) to reduce or otherwise modify--
                    ``(A) the entitlement of children with medically 
                complex conditions to early and periodic screening, 
                diagnostic, and treatment services (as defined in 
                section 1905(r)); or
                    ``(B) the informing, providing, arranging, and 
                reporting requirements of a State under section 
                1902(a)(43).

    ``(i) Definitions.--In this section:
            ``(1) Child with medically complex conditions.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                term `child with medically complex conditions' means an 
                individual under 21 years of age who--
                          ``(i) is eligible for medical assistance under 
                      the State plan (or under a waiver of such plan); 
                      and
                          ``(ii) has at least--
                                    ``(I) one or more chronic conditions 
                                that cumulatively affect three or more 
                                organ systems and severely reduces 
                                cognitive or physical functioning (such 
                                as the ability to eat, drink, or breathe 
                                independently) and that also requires 
                                the use of medication, durable medical 
                                equipment, therapy, surgery, or other 
                                treatments; or

[[Page 133 STAT. 858]]

                                    ``(II) one life-limiting illness or 
                                rare pediatric disease (as defined in 
                                section 529(a)(3) of the Federal Food, 
                                Drug, and Cosmetic Act (21 U.S.C. 
                                360ff(a)(3))).
                    ``(B) Rule of construction.--Nothing in this 
                paragraph shall prevent the Secretary from establishing 
                higher levels as to the number or severity of chronic, 
                life threatening illnesses, disabilities, rare diseases 
                or mental health conditions for purposes of determining 
                eligibility for receipt of health home services under 
                this section.
            ``(2) Chronic condition.--The term `chronic condition' means 
        a serious, long-term physical, mental, or developmental 
        disability or disease, including the following:
                    ``(A) Cerebral palsy.
                    ``(B) Cystic fibrosis.
                    ``(C) HIV/AIDS.
                    ``(D) Blood diseases, such as anemia or sickle cell 
                disease.
                    ``(E) Muscular dystrophy.
                    ``(F) Spina bifida.
                    ``(G) Epilepsy.
                    ``(H) Severe autism spectrum disorder.
                    ``(I) Serious emotional disturbance or serious 
                mental health illness.
            ``(3) Health home.--The term `health home' means a 
        designated provider (including a provider that operates in 
        coordination with a team of health care professionals) or a 
        health team selected by a child with medically complex 
        conditions (or the family of such child) to provide health home 
        services.
            ``(4) Health home services.--
                    ``(A) In general.--The term `health home services' 
                means comprehensive and timely high-quality services 
                described in subparagraph (B) that are provided by a 
                designated provider, a team of health care professionals 
                operating with such a provider, or a health team.
                    ``(B) Services described.--The services described in 
                this subparagraph shall include--
                          ``(i) comprehensive care management;
                          ``(ii) care coordination, health promotion, 
                      and providing access to the full range of 
                      pediatric specialty and subspecialty medical 
                      services, including services from out-of-State 
                      providers, as medically necessary;
                          ``(iii) comprehensive transitional care, 
                      including appropriate follow-up, from inpatient to 
                      other settings;
                          ``(iv) patient and family support (including 
                      authorized representatives);
                          ``(v) referrals to community and social 
                      support services, if relevant; and
                          ``(vi) use of health information technology to 
                      link services, as feasible and appropriate.
            ``(5) Designated provider.--The term `designated provider' 
        means a physician (including a pediatrician or a pediatric 
        specialty or subspecialty provider), children's hospital, 
        clinical practice or clinical group practice, prepaid inpatient 
        health plan or prepaid ambulatory health plan (as defined by the 
        Secretary), rural clinic, community health center, community 
        mental health center, home health agency, or any other entity or 
        provider

[[Page 133 STAT. 859]]

        that is determined by the State and approved by the Secretary to 
        be qualified to be a health home for children with medically 
        complex conditions on the basis of documentation evidencing that 
        the entity has the systems, expertise, and infrastructure in 
        place to provide health home services. Such term may include 
        providers who are employed by, or affiliated with, a children's 
        hospital.
            ``(6) Team of health care professionals.--The term `team of 
        health care professionals' means a team of health care 
        professionals (as described in the State plan amendment under 
        this section) that may--
                    ``(A) include--
                          ``(i) physicians and other professionals, such 
                      as pediatricians or pediatric specialty or 
                      subspecialty providers, nurse care coordinators, 
                      dietitians, nutritionists, social workers, 
                      behavioral health professionals, physical 
                      therapists, occupational therapists, speech 
                      pathologists, nurses, individuals with experience 
                      in medical supportive technologies, or any 
                      professionals determined to be appropriate by the 
                      State and approved by the Secretary;
                          ``(ii) an entity or individual who is 
                      designated to coordinate such a team; and
                          ``(iii) community health workers, translators, 
                      and other individuals with culturally-appropriate 
                      expertise; and
                    ``(B) be freestanding, virtual, or based at a 
                children's hospital, hospital, community health center, 
                community mental health center, rural clinic, clinical 
                practice or clinical group practice, academic health 
                center, or any entity determined to be appropriate by 
                the State and approved by the Secretary.
            ``(7) Health team.--The term `health team' has the meaning 
        given such term for purposes of section 3502 of Public Law 111-
        148.''.
SEC. 4. EXTENSION OF THE COMMUNITY MENTAL HEALTH SERVICES 
                    DEMONSTRATION PROGRAM.

    Section 223(d)(3) of the Protecting Access to Medicare Act of 2014 
(42 U.S.C. 1396a note) is amended by striking ``for 2-year demonstration 
programs under this subsection'' and inserting ``to conduct 
demonstration programs under this subsection for 2 years or through June 
30, 2019, whichever is longer''.
SEC. 5. ADDITIONAL FUNDING FOR THE MONEY FOLLOWS THE PERSON 
                    REBALANCING DEMONSTRATION.

    Section 6071(h)(1)(F) of the Deficit Reduction Act of 2005 (42 
U.S.C. 1396a note) is amended by striking ``$112,000,000'' and inserting 
``132,000,000''.
SEC. 6. PREVENTING THE MISCLASSIFICATION OF DRUGS UNDER THE 
                    MEDICAID DRUG REBATE PROGRAM.

    (a) Application of Civil Money Penalty for Misclassification of 
Covered Outpatient Drugs.--
            (1) In general.--Section 1927(b)(3) of the Social Security 
        Act (42 U.S.C. 1396r-8(b)(3)) is amended--
                    (A) in the paragraph heading, by inserting ``and 
                drug product'' after ``price'';

[[Page 133 STAT. 860]]

                    (B) in subparagraph (A)--
                          (i) in clause (ii), by striking ``; and'' at 
                      the end and inserting a semicolon;
                          (ii) in clause (iii), by striking the period 
                      at the end and inserting a semicolon;
                          (iii) in clause (iv), by striking the 
                      semicolon at the end and inserting ``; and''; and
                          (iv) by inserting after clause (iv) the 
                      following new clause:
                          ``(v) <<NOTE: Deadline.>>  not later than 30 
                      days after the last day of each month of a rebate 
                      period under the agreement, such drug product 
                      information as the Secretary shall require for 
                      each of the manufacturer's covered outpatient 
                      drugs.''; and
                    (C) in subparagraph (C)--
                          (i) in clause (ii), by inserting ``, including 
                      information related to drug pricing, drug product 
                      information, and data related to drug pricing or 
                      drug product information,'' after ``provides false 
                      information'';
                          (ii) by adding at the end the following new 
                      clauses:
                          ``(iii) Misclassified drug product or 
                      misreported information.--
                                    ``(I) <<NOTE: Penalties.>>  In 
                                general.--Any manufacturer with an 
                                agreement under this section that 
                                knowingly (as defined in section 
                                1003.110 of title 42, Code of Federal 
                                Regulations (or any successor 
                                regulation)) misclassifies a covered 
                                outpatient drug, such as by knowingly 
                                submitting incorrect drug product 
                                information, is subject to a civil money 
                                penalty for each covered outpatient drug 
                                that is misclassified in an amount not 
                                to exceed 2 times the amount of the 
                                difference between--
                                            ``(aa) the total amount of 
                                        rebates that the manufacturer 
                                        paid with respect to the drug to 
                                        all States for all rebate 
                                        periods during which the drug 
                                        was misclassified; and
                                            ``(bb) the total amount of 
                                        rebates that the manufacturer 
                                        would have been required to pay, 
                                        as determined by the Secretary 
                                        using drug product information 
                                        provided by the manufacturer, 
                                        with respect to the drug to all 
                                        States for all rebate periods 
                                        during which the drug was 
                                        misclassified if the drug had 
                                        been correctly classified.
                                    ``(II) Other penalties and recovery 
                                of underpaid rebates.--The civil money 
                                penalties described in subclause (I) are 
                                in addition to other penalties as may be 
                                prescribed by law and any other recovery 
                                of the underlying underpayment for 
                                rebates due under this section or the 
                                terms of the rebate agreement as 
                                determined by the Secretary.
                          ``(iv) Increasing oversight and enforcement.--
                      Each year the Secretary shall retain, in addition 
                      to any amount retained by the Secretary to recoup 
                      investigation and litigation costs related to the 
                      enforcement of the civil money penalties under 
                      this subparagraph

[[Page 133 STAT. 861]]

                      and subsection (c)(4)(B)(ii)(III), an amount equal 
                      to 25 percent of the total amount of civil money 
                      penalties collected under this subparagraph and 
                      subsection (c)(4)(B)(ii)(III) for the year, and 
                      such retained amount shall be available to the 
                      Secretary, without further appropriation and until 
                      expended, for activities related to the oversight 
                      and enforcement of this section and agreements 
                      under this section, including--
                                    ``(I) improving drug data reporting 
                                systems;
                                    ``(II) evaluating and ensuring 
                                manufacturer compliance with rebate 
                                obligations; and
                                    ``(III) oversight and enforcement 
                                related to ensuring that manufacturers 
                                accurately and fully report drug 
                                information, including data related to 
                                drug classification.''; and
                          (iii) in subparagraph (D)--
                                    (I) in clause (iv), by striking ``, 
                                and'' and inserting a comma;
                                    (II) in clause (v), by striking the 
                                period and inserting ``, and''; and
                                    (III) by inserting after clause (v) 
                                the following new clause:
                          ``(vi) in the case of categories of drug 
                      product or classification information that were 
                      not considered confidential by the Secretary on 
                      the day before the date of the enactment of this 
                      clause.''.
            (2) Technical amendments.--
                    (A) Section 1903(i)(10) of the Social Security Act 
                (42 U.S.C. 1396b(i)(10)) is amended--
                          (i) in subparagraph (C)--
                                    (I) by adjusting the left margin so 
                                as to align with the left margin of 
                                subparagraph (B); and
                                    (II) by striking ``, and'' and 
                                inserting a semicolon;
                          (ii) in subparagraph (D), by striking ``; or'' 
                      and inserting ``; and''; and
                          (iii) by adding at the end the following new 
                      subparagraph:
            ``(E) with respect to any amount expended for a covered 
        outpatient drug for which a suspension under section 
        1927(c)(4)(B)(ii)(II) is in effect; or''.
                    (B) Section 1927(b)(3)(C)(ii) of the Social Security 
                Act (42 U.S.C. 1396r-8(b)(3)(C)(ii)) is amended by 
                striking ``subsections (a) and (b)'' and inserting 
                ``subsections (a), (b), (f)(3), and (f)(4)''.

    (b) Recovery of Unpaid Rebate Amounts Due to Misclassification of 
Covered Outpatient Drugs.--
            (1) In general.--Section 1927(c) of the Social Security Act 
        (42 U.S.C. 1396r-8(c)) is amended by adding at the end the 
        following new paragraph:
            ``(4) Recovery of unpaid rebate amounts due to 
        misclassification of covered outpatient drugs.--
                    ``(A) <<NOTE: Determination.>>  In general.--If the 
                Secretary determines that a manufacturer with an 
                agreement under this section paid a lower per-unit 
                rebate amount to a State for a rebate period as a result 
                of the misclassification by the manufacturer of a 
                covered outpatient drug (without regard to

[[Page 133 STAT. 862]]

                whether the manufacturer knowingly made the 
                misclassification or should have known that the 
                misclassification would be made) than the per-unit 
                rebate amount that the manufacturer would have paid to 
                the State if the drug had been correctly classified, the 
                manufacturer shall pay to the State an amount equal to 
                the product of--
                          ``(i) the difference between--
                                    ``(I) the per-unit rebate amount 
                                paid to the State for the period; and
                                    ``(II) the per-unit rebate amount 
                                that the manufacturer would have paid to 
                                the State for the period, as determined 
                                by the Secretary, if the drug had been 
                                correctly classified; and
                          ``(ii) the total units of the drug paid for 
                      under the State plan in the period.
                    ``(B) Authority to correct misclassifications.--
                          ``(i) <<NOTE: Determination. Notification.>>  
                      In general.--If the Secretary determines that a 
                      manufacturer with an agreement under this section 
                      has misclassified a covered outpatient drug 
                      (without regard to whether the manufacturer 
                      knowingly made the misclassification or should 
                      have known that the misclassification would be 
                      made), the Secretary shall notify the manufacturer 
                      of the misclassification and require the 
                      manufacturer to correct the misclassification in a 
                      timely manner.
                          ``(ii) Enforcement.--If, after receiving 
                      notice of a misclassification from the Secretary 
                      under clause (i), a manufacturer fails to correct 
                      the misclassification by such time as the 
                      Secretary shall require, until the manufacturer 
                      makes such correction, the Secretary may do any or 
                      all of the following:
                                    ``(I) Correct the misclassification, 
                                using drug product information provided 
                                by the manufacturer, on behalf of the 
                                manufacturer.
                                    ``(II) Suspend the misclassified 
                                drug and the drug's status as a covered 
                                outpatient drug under the manufacturer's 
                                national rebate agreement, and exclude 
                                the misclassified drug from Federal 
                                financial participation in accordance 
                                with section 1903(i)(10)(E).
                                    ``(III) <<NOTE: Penalties.>>  Impose 
                                a civil money penalty (which shall be in 
                                addition to any other recovery or 
                                penalty which may be available under 
                                this section or any other provision of 
                                law) for each rebate period during which 
                                the drug is misclassified not to exceed 
                                an amount equal to the product of--
                                            ``(aa) the total number of 
                                        units of each dosage form and 
                                        strength of such misclassified 
                                        drug paid for under any State 
                                        plan during such a rebate 
                                        period; and
                                            ``(bb) 23.1 percent of the 
                                        average manufacturer price for 
                                        the dosage form and strength of 
                                        such misclassified drug.
                    ``(C) Reporting and transparency.--
                          ``(i) In general.--The Secretary shall submit 
                      a report to Congress on at least an annual basis 
                      that

[[Page 133 STAT. 863]]

                      includes information on the covered outpatient 
                      drugs that have been identified as misclassified, 
                      any steps taken to reclassify such drugs, the 
                      actions the Secretary has taken to ensure the 
                      payment of any rebate amounts which were unpaid as 
                      a result of such misclassification, and a 
                      disclosure of expenditures from the fund created 
                      in subsection (b)(3)(C)(iv), including an 
                      accounting of how such funds have been allocated 
                      and spent in accordance with such subsection.
                          ``(ii) Public access.--The Secretary shall 
                      make the information contained in the report 
                      required under clause (i) available to the public 
                      on a timely basis.
                    ``(D) Other penalties and actions.--Actions taken 
                and penalties imposed under this clause shall be in 
                addition to other remedies available to the Secretary 
                including terminating the manufacturer's rebate 
                agreement for noncompliance with the terms of such 
                agreement and shall not exempt a manufacturer from, or 
                preclude the Secretary from pursuing, any civil money 
                penalty under this title or title XI, or any other 
                penalty or action as may be prescribed by law.''.
            (2) Offset of recovered amounts against medical 
        assistance.--Section 1927(b)(1)(B) of the Social Security Act 
        (42 U.S.C. 1396r-8(b)(1)(B)) is amended by inserting ``, 
        including amounts received by a State under subsection (c)(4),'' 
        after ``in any quarter''.

    (c) Clarifying Definitions.--Section 1927(k) of the Social Security 
Act (42 U.S.C. 1396r-8(k)) is amended--
            (1) in paragraph (2)(A), by striking ``paragraph (5)'' and 
        inserting ``paragraph (4)''; and
            (2) in paragraph (7)(A)--
                    (A) by striking ``an original new drug application'' 
                and inserting ``a new drug application'' each place it 
                appears;
                    (B) in clause (i), by striking ``(not including any 
                drug described in paragraph (5))'' and inserting ``, 
                including a drug product approved for marketing as a 
                non-prescription drug that is regarded as a covered 
                outpatient drug under paragraph (4),'';
                    (C) in clause (ii)--
                          (i) by striking ``was originally marketed'' 
                      and inserting ``is marketed''; and
                          (ii) by inserting ``, unless the Secretary 
                      determines that a narrow exception applies (as 
                      described in section 447.502 of title 42, Code of 
                      Federal Regulations (or any successor 
                      regulation))'' before the period; and
                    (D) in clause (iv)--
                          (i) by inserting ``, including a drug product 
                      approved for marketing as a non-prescription drug 
                      that is regarded as a covered outpatient drug 
                      under paragraph (4),'' after ``covered outpatient 
                      drug'';
                          (ii) by inserting ``unless the Secretary 
                      determines that a narrow exception applies (as 
                      described in section 447.502 of title 42, Code of 
                      Federal Regulations (or any successor 
                      regulation))'' after ``under the new drug 
                      application''; and
                          (iii) by adding at the end the following new 
                      sentence: ``Such term also includes a covered 
                      outpatient

[[Page 133 STAT. 864]]

                      drug that is a biological product licensed, 
                      produced, or distributed under a biologics license 
                      application approved by the Food and Drug 
                      Administration.''.

    (d) Exclusion of Manufacturers for Knowing Misclassification of 
Covered Outpatient Drugs.--Section 1128(b) of the Social Security Act 
(42 U.S.C. 1320a-7(b)) is amended by adding at the end the following new 
paragraph:
            ``(17) Knowingly misclassifying covered outpatient drugs.--
        Any manufacturer or officer, director, agent, or managing 
        employee of such manufacturer that knowingly misclassifies a 
        covered outpatient drug under an agreement under section 1927, 
        knowingly fails to correct such misclassification, or knowingly 
        provides false information related to drug pricing, drug product 
        information, or data related to drug pricing or drug product 
        information.''.

    (e) <<NOTE: 42 USC 1320a-7 note.>>  Effective Date.--The amendments 
made by this section shall take effect on the date of the enactment of 
this Act, and shall apply to covered outpatient drugs supplied by 
manufacturers under agreements under section 1927 of the Social Security 
Act (42 U.S.C. 1396r-8) on or after such date.
SEC. 7. EXTENSION OF THIRD-PARTY LIABILITY PERIOD FOR CHILD 
                    SUPPORT SERVICES.

    (a) In General.--Section 202(a)(2) of the Bipartisan Budget Act of 
2013 (Public Law 113-67) is amended by striking ``90 days'' and 
inserting ``100 days''.
    (b) <<NOTE: 42 USC 1396a note.>>  Effective Date.--The amendment 
made by this section shall take effect on the date of the enactment of 
this Act.
SEC. 8. DENIAL OF FFP FOR CERTAIN EXPENDITURES RELATING TO VACUUM 
                    ERECTION SYSTEMS AND PENILE PROSTHETIC 
                    IMPLANTS.

    (a) In General.--Section 1903(i) of the Social Security Act (42 
U.S.C. 1396b(i)) is amended by inserting after paragraph (11) the 
following:
            ``(12) with respect to any amounts expended for--
                    ``(A) a vacuum erection system that is not medically 
                necessary; or
                    ``(B) the insertion, repair, or removal and 
                replacement of a penile prosthetic implant (unless such 
                insertion, repair, or removal and replacement is 
                medically necessary); or''.

    (b) <<NOTE: 42 USC 1396b note.>>  Effective Date.--The amendment 
made by subsection (a) shall apply with respect to items and services 
furnished on or after January 1, 2020.
SEC. 9. DETERMINATION OF BUDGETARY EFFECTS.

    The budgetary effects of this Act, for the purpose of complying with 
the Statutory Pay-As-You-Go Act of 2010, shall be determined by 
reference to the latest statement titled ``Budgetary Effects of PAYGO 
Legislation'' for this Act, submitted for printing in the

[[Page 133 STAT. 865]]

Congressional Record by the Chairman of the House Budget Committee, 
provided that such statement has been submitted prior to the vote on 
passage.

    Approved April 18, 2019.

LEGISLATIVE HISTORY--H.R. 1839:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 165 (2019):
            Mar. 25, considered and passed House.
            Apr. 2, considered and passed Senate.

                                  <all>