[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5808 Reported in House (RH)]

<DOC>





                                                 Union Calendar No. 561
115th CONGRESS
  2d Session
                                H. R. 5808

                          [Report No. 115-726]

  To amend title XIX of the Social Security Act to require States to 
  operate drug management programs for at-risk beneficiaries, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 15, 2018

    Mr. Bilirakis (for himself and Mr. Ben Ray Lujan of New Mexico) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

                             June 12, 2018

           Additional sponsors: Mrs. Blackburn and Mr. Walden

                             June 12, 2018

Committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed


_______________________________________________________________________

                                 A BILL


 
  To amend title XIX of the Social Security Act to require States to 
  operate drug management programs for at-risk beneficiaries, 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.

    This Act may be cited as the ``Medicaid Pharmaceutical Home Act of 
2018''.

SEC. 2. 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 and the 
                same chain identification number, 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 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 and refuse to be a provider or 
                pharmacy 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 dosage and pill count 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 (e)(2) with respect to years.
        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.
                                                 Union Calendar No. 561

115th CONGRESS

  2d Session

                               H. R. 5808

                          [Report No. 115-726]

_______________________________________________________________________

                                 A BILL

  To amend title XIX of the Social Security Act to require States to 
  operate drug management programs for at-risk beneficiaries, and for 
                            other purposes.

_______________________________________________________________________

                             June 12, 2018

Committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed