```

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5605 Engrossed in House (EH)]

<DOC>
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
115th CONGRESS
  2d Session
                                H. R. 5605

_______________________________________________________________________

                                 AN ACT

 
   To amend title XVIII of the Social Security Act to provide for an 
  opioid use disorder treatment demonstration program, 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 ``Advancing High Quality Treatment for 
Opioid Use Disorders in Medicare Act''.

SEC. 2. OPIOID USE DISORDER TREATMENT DEMONSTRATION PROGRAM.

    Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is 
amended by inserting after section 1866E (42 U.S.C. 1395cc-5) the 
following new section:

``SEC. 1866F. OPIOID USE DISORDER TREATMENT DEMONSTRATION PROGRAM.

    ``(a) Implementation of 4-Year Demonstration Program.--
            ``(1) In general.--Not later than January 1, 2021, the 
        Secretary shall implement a 4-year demonstration program under 
        this title (in this section referred to as the `Program') to 
        increase access of applicable beneficiaries to opioid use 
        disorder treatment services, improve physical and mental health 
        outcomes for such beneficiaries, and to the extent possible, 
        reduce expenditures under this title. Under the Program, the 
        Secretary shall make payments under subsection (e) to 
        participants (as defined in subsection (c)(1)(A)) for 
        furnishing opioid use disorder treatment services delivered 
        through opioid use disorder care teams, or arranging for such 
        service to be furnished, to applicable beneficiaries 
        participating in the Program.
            ``(2) Opioid use disorder treatment services.--For purposes 
        of this section, the term `opioid use disorder treatment 
        services'--
                    ``(A) means, with respect to an applicable 
                beneficiary, services that are furnished for the 
                treatment of opioid use disorders and that utilize 
                drugs approved under section 505 of the Federal Food, 
                Drug, and Cosmetic Act for the treatment of opioid use 
                disorders in an outpatient setting; and
                    ``(B) includes--
                            ``(i) medication assisted treatment;
                            ``(ii) treatment planning;
                            ``(iii) psychiatric, psychological, or 
                        counseling services (or any combination of such 
                        services), as appropriate;
                            ``(iv) social support services, as 
                        appropriate; and
                            ``(v) care management and care coordination 
                        services, including coordination with other 
                        providers of services and suppliers not on an 
                        opioid use disorder care team.
    ``(b) Program Design.--
            ``(1) In general.--The Secretary shall design the Program 
        in such a manner to allow for the evaluation of the extent to 
        which the Program accomplishes the following purposes:
                    ``(A) Reduces hospitalizations and emergency 
                department visits.
                    ``(B) Increases use of medication-assisted 
                treatment for opioid use disorders.
                    ``(C) Improves health outcomes of individuals with 
                opioid use disorders, including by reducing the 
                incidence of infectious diseases (such as hepatitis C 
                and HIV).
                    ``(D) Does not increase the total spending on items 
                and services under this title.
                    ``(E) Reduces deaths from opioid overdose.
                    ``(F) Reduces the utilization of inpatient 
                residential treatment.
            ``(2) Consultation.--In designing the Program, including 
        the criteria under subsection (e)(2)(A), the Secretary shall, 
        not later than 3 months after the date of the enactment of this 
        section, consult with specialists in the field of addiction, 
        clinicians in the primary care community, and beneficiary 
        groups.
    ``(c) Participants; Opioid Use Disorder Care Teams.--
            ``(1) Participants.--
                    ``(A) Definition.--In this section, the term 
                `participant' means an entity or individual--
                            ``(i) that is otherwise enrolled under this 
                        title and that is--
                                    ``(I) a physician (as defined in 
                                section 1861(r)(1));
                                    ``(II) a group practice comprised 
                                of at least one physician described in 
                                subclause (I);
                                    ``(III) a hospital outpatient 
                                department;
                                    ``(IV) a federally qualified health 
                                center (as defined in section 
                                1861(aa)(4));
                                    ``(V) a rural health clinic (as 
                                defined in section 1861(aa)(2));
                                    ``(VI) a community mental health 
                                center (as defined in section 
                                1861(ff)(3)(B));
                                    ``(VII) a clinic certified as a 
                                certified community behavioral health 
                                clinic pursuant to section 223 of the 
                                Protecting Access to Medicare Act of 
                                2014; or
                                    ``(VIII) any other individual or 
                                entity specified by the Secretary;
                            ``(ii) that applied for and was selected to 
                        participate in the Program pursuant to an 
                        application and selection process established 
                        by the Secretary; and
                            ``(iii) that establishes an opioid use 
                        disorder care team (as defined in paragraph 
                        (2)) through employing or contracting with 
                        health care practitioners described in 
                        paragraph (2)(A), and uses such team to furnish 
                        or arrange for opioid use disorder treatment 
                        services in the outpatient setting under the 
                        Program.
                    ``(B) Preference.--In selecting participants for 
                the Program, the Secretary shall give preference to 
                individuals and entities that are located in areas with 
                a prevalence of opioid use disorders that is higher 
                than the national average prevalence.
            ``(2) Opioid use disorder care teams.--
                    ``(A) In general.--For purposes of this section, 
                the term `opioid use disorder care team' means a team 
                of health care practitioners established by a 
                participant described in paragraph (1)(A) that--
                            ``(i) shall include--
                                    ``(I) at least one physician (as 
                                defined in section 1861(r)(1)) 
                                furnishing primary care services or 
                                addiction treatment services to an 
                                applicable beneficiary; and
                                    ``(II) at least one eligible 
                                practitioner (as defined in paragraph 
                                (3)(A)), who may be a physician who 
                                meets the criterion in subclause (I); 
                                and
                            ``(ii) may include other practitioners 
                        licensed under State law to furnish 
                        psychiatric, psychological, counseling, and 
                        social services to applicable beneficiaries.
                    ``(B) Requirements for receipt of payment under 
                program.--In order to receive payments under subsection 
                (e), each participant in the Program shall--
                            ``(i) furnish opioid use disorder treatment 
                        services through opioid use disorder care teams 
                        to applicable beneficiaries who agree to 
                        receive the services;
                            ``(ii) meet minimum criteria, as 
                        established by the Secretary; and
                            ``(iii) submit to the Secretary, in such 
                        form, manner, and frequency as specified by the 
                        Secretary, with respect to each applicable 
                        beneficiary for whom opioid use disorder 
                        treatment services are furnished by the opioid 
                        use disorder care team, data and such other 
                        information as the Secretary determines 
                        appropriate to--
                                    ``(I) monitor and evaluate the 
                                Program;
                                    ``(II) determine if minimum 
                                criteria are met under clause (ii); and
                                    ``(III) determine the incentive 
                                payment under subsection (e).
            ``(3) Eligible practitioners; other provider-related 
        definitions and application provisions.--
                    ``(A) Eligible practitioners.--For purposes of this 
                section, the term `eligible practitioner' means a 
                physician or other health care practitioner, such as a 
                nurse practitioner, that--
                            ``(i) is enrolled under section 1866(j)(1);
                            ``(ii) is authorized to prescribe or 
                        dispense narcotic drugs to individuals for 
                        maintenance treatment or detoxification 
                        treatment; and
                            ``(iii) has in effect a waiver in 
                        accordance with section 303(g) of the 
                        Controlled Substances Act for such purpose and 
                        is otherwise in compliance with regulations 
                        promulgated by the Substance Abuse and Mental 
                        Health Services Administration to carry out 
                        such section.
                    ``(B) Addiction specialists.--For purposes of 
                subsection (e)(1)(B)(iv), the term `addiction 
                specialist' means a physician that possesses expert 
                knowledge and skills in addiction medicine, as 
                evidenced by appropriate certification from a specialty 
                body, a certificate of advanced qualification in 
                addiction medicine, or completion of an accredited 
                residency or fellowship in addiction medicine or 
                addiction psychiatry, as determined by the Secretary.
    ``(d) Participation of Applicable Beneficiaries.--
            ``(1) Applicable beneficiary defined.--In this section, the 
        term `applicable beneficiary' means an individual who--
                    ``(A) is entitled to, or enrolled for, benefits 
                under part A and enrolled for benefits under part B;
                    ``(B) is not enrolled in a Medicare Advantage plan 
                under part C;
                    ``(C) has a current diagnosis for an opioid use 
                disorder; and
                    ``(D) meets such other criteria as the Secretary 
                determines appropriate.
        Such term shall include an individual who is dually eligible 
        for benefits under this title and title XIX if such individual 
        satisfies the criteria described in subparagraphs (A) through 
        (D).
            ``(2) Voluntary participation; limitation on number of 
        participants.--An applicable beneficiary may participate in the 
        Program on a voluntary basis and may terminate participation in 
        the Program at any time. Not more than 20,000 applicable 
        beneficiaries may participate in the Program at any time.
            ``(3) Services.--In order to participate in the Program, an 
        applicable beneficiary shall agree to receive opioid use 
        disorder treatment services from a participant. Participation 
        under the Program shall not affect coverage of or payment for 
        any other item or service under this title for the applicable 
        beneficiary.
            ``(4) Beneficiary access to services.--Nothing in this 
        section shall be construed as encouraging providers to limit 
        applicable beneficiary access to services covered under this 
        title and applicable beneficiaries shall not be required to 
        relinquish access to any benefit under this title as a 
        condition of receiving services from a participant in the 
        Program.
    ``(e) Payments.--
            ``(1) Per applicable beneficiary per month care management 
        fee.--
                    ``(A) In general.--The Secretary shall establish a 
                schedule of per applicable beneficiary per month care 
                management fees. Such a per applicable beneficiary per 
                month care management fee shall be paid to a 
                participant in addition to any other amount otherwise 
                payable under this title to the health care 
                practitioners in the participant's opioid use disorder 
                care team or, if applicable, to the participant. A 
                participant may use such per applicable beneficiary per 
                month care management fee to deliver additional 
                services to applicable beneficiaries, including 
                services not otherwise eligible for payment under this 
                title.
                    ``(B) Payment amounts.--In carrying out 
                subparagraph (A), the Secretary shall--
                            ``(i) consider payments otherwise payable 
                        under this title for opioid use disorder 
                        treatment services and the needs of applicable 
                        beneficiaries;
                            ``(ii) pay a higher per applicable 
                        beneficiary per month care management fee for 
                        an applicable beneficiary who receives more 
                        intensive treatment services from a participant 
                        and for whom those services are appropriate 
                        based on clinical guidelines for opioid use 
                        disorder care;
                            ``(iii) pay a higher per applicable 
                        beneficiary per month care management fee for 
                        the month in which the applicable beneficiary 
                        begins treatment with a participant than in 
                        subsequent months, to reflect the greater time 
                        and costs required for the planning and 
                        initiation of treatment, as compared to 
                        maintenance of treatment;
                            ``(iv) pay higher per applicable 
                        beneficiary per month care management fees for 
                        participants that have established opioid use 
                        disorder care teams that include an addiction 
                        specialist (as defined in subsection 
                        (c)(3)(B)); and
                            ``(v) take into account whether a 
                        participant's opioid use disorder care team 
                        refers applicable beneficiaries to other 
                        suppliers or providers for any opioid use 
                        disorder treatment services.
                    ``(C) No duplicate payment.--The Secretary shall 
                make payments under this paragraph to only one 
                participant for services furnished to an applicable 
                beneficiary during a calendar month.
            ``(2) Incentive payments.--
                    ``(A) In general.--Under the Program, the Secretary 
                shall establish a performance-based incentive payment, 
                which shall be paid (using a methodology established 
                and at a time determined appropriate by the Secretary) 
                to participants based on the performance of 
                participants with respect to criteria, as determined 
                appropriate by the Secretary, in accordance with 
                subparagraph (B).
                    ``(B) Criteria.--
                            ``(i) In general.--Criteria described in 
                        subparagraph (A) may include consideration of 
                        the following:
                                    ``(I) Patient engagement and 
                                retention in treatment.
                                    ``(II) Evidence-based medication-
                                assisted treatment.
                                    ``(III) Other criteria established 
                                by the Secretary.
                            ``(ii) Required consultation and 
                        consideration.--In determining criteria 
                        described in subparagraph (A), the Secretary 
                        shall--
                                    ``(I) consult with stakeholders, 
                                including clinicians in the primary 
                                care community and in the field of 
                                addiction medicine; and
                                    ``(II) consider existing clinical 
                                guidelines for the treatment of opioid 
                                use disorders.
                    ``(C) No duplicate payment.--The Secretary shall 
                ensure that no duplicate payments under this paragraph 
                are made with respect to an applicable beneficiary.
    ``(f) Multipayer Strategy.--In carrying out the Program, the 
Secretary shall encourage other payers to provide similar payments and 
to use similar criteria as applied under the Program under subsection 
(e)(2)(C). The Secretary may enter into a memorandum of understanding 
with other payers to align the methodology for payment provided by such 
a payer related to opioid use disorder treatment services with such 
methodology for payment under the Program.
    ``(g) Evaluation.--
            ``(1) In general.--The Secretary shall conduct an 
        intermediate and final evaluation of the program. Each such 
        evaluation shall determine the extent to which each of the 
        purposes described in subsection (b) have been accomplished 
        under the Program.
            ``(2) Reports.--The Secretary shall submit to the Secretary 
        and Congress--
                    ``(A) a report with respect to the intermediate 
                evaluation under paragraph (1) not later than 3 years 
                after the date of the implementation of the Program; 
                and
                    ``(B) a report with respect to the final evaluation 
                under paragraph (1) not later than 6 years after such 
                date.
    ``(h) Funding.--
            ``(1) Administrative funding.--For the purposes of 
        implementing, administering, and carrying out the Program 
        (other than for purposes described in paragraph (2)), $5 
        million shall be available from the Federal Supplementary 
        Medical Insurance Trust Fund under section 1841.
            ``(2) Care management fees and incentives.--For the 
        purposes of making payments under subsection (e), $10 million 
        shall be available from the Federal Supplementary Medical 
        Insurance Trust Fund under section 1841 for each of fiscal 
        years 2021 through 2024.
            ``(3) Availability.--Amounts transferred under this 
        subsection for a fiscal year shall be available until expended.
    ``(i) Waivers.--The Secretary may waive any provision of this title 
as may be necessary to carry out the Program under this section.''.

SEC. 3. 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 1 
                        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.

            Passed the House of Representatives June 19, 2018.

            Attest:

                                                                 Clerk.
115th CONGRESS

  2d Session

                               H. R. 5605

_______________________________________________________________________

                                 AN ACT

   To amend title XVIII of the Social Security Act to provide for an 
  opioid use disorder treatment demonstration program, and for other 
                               purposes.
```