Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act

Bill: 115-hr-5605
Sponsor: full_name: Rep. Ruiz, Raul [D-CA-36]
Introduced: 2018-04-24
Policy area: Health
Subjects: Congressional oversight

Drug therapy

Drug trafficking and controlled substances

Drug, alcohol, tobacco use

Government studies and investigations

Health care quality

Health personnel

Health programs administration and funding

Home and outpatient care

Hospital care

Medicare

Mental health

Performance measurement

Prescription drugs

User charges and fees
Latest action: action_date: 2018-06-20
text: Received in the Senate and Read twice and referred to the Committee on Finance.

Summaries:
action_date: 2018-04-24
action_desc: Introduced in House
text: <p><b>Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act</b></p> <p>This bill requires the Centers for Medicare &amp; Medicaid Services (CMS) to carry out a demonstration program to: (1) increase access of opioid use disorder treatment services for Medicare beneficiaries, (2) improve physical and mental health outcomes for such beneficiaries, and (3) reduce Medicare expenditures. <br /></p> <p>Opioid use disorder care teams of practitioners&nbsp;may apply for participation in the demonstration project. The CMS must establish a performance-based incentive payment for participating&nbsp;teams.</p> <p>The CMS must adopt or develop program quality standards and performance methods.<br /></p>

action_date: 2018-06-12
action_desc: Reported to House amended, Part I
text: <p><b>Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act</b></p> <p>This bill requires the Centers for Medicare &amp; Medicaid Services (CMS) to carry out a demonstration program to: (1) increase access&nbsp;to opioid-use disorder treatment services for Medicare beneficiaries, (2) improve physical and mental health outcomes for such beneficiaries, and (3) reduce Medicare expenditures. </p> <p>Opioid-use disorder care teams of practitioners&nbsp;may apply for participation in the demonstration project. The CMS must establish a performance-based incentive payment for participants.</p> <p><br /></p>

action_date: 2018-06-19
action_desc: Passed House amended
text: <p><b>Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act</b></p> <p>(Sec. 2) This bill requires the Centers for Medicare &amp; Medicaid Services (CMS) to carry out a demonstration program to: (1) increase access&nbsp;to opioid-use disorder treatment services for Medicare beneficiaries, (2) improve physical and mental health outcomes for such beneficiaries, and (3) reduce Medicare expenditures. </p> <p>Opioid-use disorder care teams of practitioners&nbsp;may apply for participation in the demonstration project. The CMS must establish a performance-based incentive payment for participants.</p> <p>(Sec. 3) The bill also requires prescriptions for controlled substances that are covered under the Medicare prescription drug benefit or Medicare Advantage prescription drug plans to be transmitted via electronic prescription programs. The CMS may waive such requirements under specified circumstances.<br /></p>

tv_txt: I 115th CONGRESS 2d Session H. R. 5605 IN THE HOUSE OF REPRESENTATIVES April 24, 2018 Mr. Ruiz introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Ways and Means , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title XVIII of the Social Security Act to provide for an opioid use disorder treatment demonstration program.

1. Short title This Act may be cited as the Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act . 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: 1866F. Opioid use disorder treatment demonstration program (a) Implementation of 5-Year demonstration program (1) In general Not later than January 1, 2021, the Secretary shall implement a 5-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 (f) to participating care teams (as defined in subsection (c)(1)(A)) for providing opioid use disorder treatment services to applicable beneficiaries participating under 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 in an outpatient setting and— (i) which are supported by the per applicable beneficiary per month care management fee under subsection (f); or (ii) for which payment may otherwise be made under this title; and (B) includes— (i) medication assisted treatment; (ii) treatment planning; (iii) appropriate outpatient psychiatric, psychological, or counseling services (or any combination of such services); (iv) appropriate social support services; and (v) care management and care coordination of opioid use disorder services, as well as coordination with other physicians and providers treating the mental and physical conditions of such beneficiary. (b) Program design (1) In general The Secretary shall design the Program in such a manner to evaluate the extent to which the Program accomplishes the following purposes: (A) Reduces hospitalizations and emergency department visits. (B) Reduces the occurrence of overdoses from opioids, including prescription opioid medications as well as illicit opioids. (C) Increases use of medication-assisted treatment for opioid use disorders. (D) Improves health outcomes of individuals with opioid use disorders, including by reducing the incidence of infectious diseases (such as hepatitis C and HIV). (E) Does not increase the total spending on health care services under this title. (F) Reduces deaths from opioid poisoning. (G) Reduces the utilization of inpatient residential treatment. (2) Consultation In designing the Program, 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 and clinicians in the primary care community. (c) Participating care teams (1) Definition; selection (A) Definition In this section, the term participating care team means an opioid use disorder care team (as defined in paragraph (2)) that is participating under the Program pursuant to selection by the Secretary under subparagraph (B). (B) Selection Under the Program, the Secretary shall provide for a process for opioid use disorder care teams to apply for participation under the Program as participating care teams and for selecting such teams for such participation. (C) Preference In selecting opioid use disorder care teams under subparagraph (B) for participation under the Program, the Secretary shall give preference to opioid use disorder care teams that are located in areas with a prevalence of opioid use disorders that is higher than the national average prevalence, as measured by aggregate overdoses of opioids, or any other measure that the Secretary deems appropriate. (2) Opioid use disorder care teams (A) In general For purposes of this section, the term opioid use disorder care team means a group of health care practitioners, or an entity employing or contracting with such health care practitioners, that— (i) includes at least one physician who is providing primary care services or addiction treatment services to an applicable beneficiary during the period in which the opioid use disorder care team is receiving payments under subsection (f); (ii) includes at least one eligible practitioner (as defined in paragraph (3)(A)), who may be a physician who meets the criterion in clause (i); and (iii) includes other practitioners— (I) as necessary to deliver appropriate psychiatric, psychological, counseling, and social services to applicable beneficiaries in addition to the services delivered by the eligible practitioner; and (II) who only perform services that such practitioners are legally authorized to perform under State law. (B) Requirements for participation In order for an opioid use disorder care team to participate in the Program as a participating care team, each of the practitioners participating on the team shall agree to— (i) deliver opioid use disorder treatment services to applicable beneficiaries who agree to receive the services; (ii) meet minimum standards for quality required by the Program; and (iii) submit to the Secretary, with respect to each applicable beneficiary for whom such practitioner provides opioid use disorder treatment services, data with respect to the quality standards and the measures defined in subsection (d) and such other information as the Secretary determines appropriate to monitor and evaluate the Program and to determine the performance of each practitioner for purposes of the incentive payment under subsection (f), in such form, manner, and frequency as specified by the Secretary. (3) Eligible practitioners; Other provider-related definitions and application provisions (A) Eligible practitioners For purposes of this section, the term eligible practitioner means, with respect to an applicable beneficiary, a provider of services that— (i) participates in the Medicare program under this title; (ii) (I) is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment; and (II) has in effect a registration or 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; and (iii) with respect to furnishing opioid use disorder treatment services to the applicable beneficiary, participates in an opioid use disorder care team, which is a participating care team. (B) Addiction specialists For purposes of paragraph (2)(C), the term addiction specialist means a physician that possesses expert knowledge and skills in addiction medicine, as evidenced by— (i) certification by the American Society of Addiction Medicine or the American Board of Addiction Medicine; (ii) subspecialty certification in addiction medicine by the American Board of Preventive Medicine; (iii) subspecialty certification in addiction psychiatry by the American Board of Psychiatry and Neurology; (iv) a certificate of added qualification in addiction medicine conferred by the American Osteopathic Association; or (v) completion of an accredited residency or fellowship in addiction medicine or addiction psychiatry. (d) Quality and other reporting requirements (1) Adoption and development of standards and performance measures Not later than 9 months after the date of the enactment of this section, the Secretary, in conjunction with stakeholders (including clinicians in the primary care community and the field of addiction medicine), shall adopt or develop (or an appropriate entity with which the Secretary contracts shall develop) quality standards and methods of assessing the quality of care to ensure a minimum level of quality of care and to determine whether the services furnished by participating care teams are achieving the purposes described in subsection (b)(1). For purposes of adopting or developing standards for payments under subsection (f)(1) and for purposes of adopting or developing methods for assessing performance for the incentive payments under subsection (f)(2), the Secretary may consider existing clinical guidelines for the treatment of opioid use disorders and standards or measures applied for use under the Medicaid program under title XIX. Standards and assessment methods shall address the following outcomes and performance criteria: (A) Patient engagement in treatment. (B) Retention in treatment. (C) Provision of evidence-based medication-assisted treatment. (D) Any other criteria the Secretary deems appropriate. (2) Submission Each participating care team shall submit to the Secretary, in such form, manner, and frequency specified by the Secretary, data with respect to such standards and assessment methods and such other information as the Secretary determines appropriate to monitor and evaluate the Program and to determine the performance of such team for purposes of the incentive payment under subsection (f)(2). (e) Participation of applicable beneficiaries (1) Applicable beneficiary defined In this section, the term applicable beneficiary means an individual who— (A) is entitled to 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 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 An applicable beneficiary may participate in the Program on a voluntary basis and may terminate participation in the Program at any time. (3) Services In order to participate in the Program, an applicable beneficiary must agree to receive opioid use disorder treatment services from a participating care team. An applicable beneficiary may only receive services supported by the Program from one participating care team during any one calendar month. 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 participating care team. (f) 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 participating care team in addition to any other amount otherwise payable under this title to the practitioners participating with the team or, if applicable, the entity with respect to such team employing or contracting with such practitioners. A participating care team 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) Application In carrying out subparagraph (A), the Secretary shall— (i) consider the costs that participating care teams are expected to incur in delivering high-quality opioid use disorder care services that are not covered by payments otherwise payable to the teams under this title; (ii) pay a higher per applicable beneficiary per month care management fee for an applicable beneficiary who receives more intensive treatment services from a participating care team and who is appropriate for such services 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 participating care team than in subsequent months, to reflect the greater time and costs required for the team to plan and initiate treatment, as compared to maintenance of treatment; and (iv) pay higher per applicable beneficiary per month care management fees for participating care teams that include an addiction specialist who is either delivering services directly to applicable beneficiaries or providing consulting support to those practitioners participating with such teams who are delivering services to applicable beneficiaries. (2) Incentive payments Under the Program, the Secretary shall establish a performance-based incentive payment, which shall be paid to participating care teams based on the performance of such teams with respect to standards and assessment methods adopted or developed by the Secretary under subsection (d) and with respect to which the teams report under such subsection. (g) Multipayer strategy In carrying out the Program, the Secretary shall encourage other payers to provide similar payments and to use similar quality standards and methods of assessment as applied under the Program. 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. (h) Evaluation (1) In general The Comptroller General of the United States 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. Each evaluation shall also determine the extent to which the structure and requirements of the Program facilitated or impeded the participation of practitioners in the program, the participation of beneficiaries with opioid use disorder, and the delivery of high-quality opioid use disorder treatment services. (2) Reports The Comptroller General of the United States 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. (i) Funding (1) Administrative funding For the purposes of implementing, administering, and carrying out the Program (other than for purposes described in paragraph (2)), there shall be transferred to the Secretary for the Center for Medicare & Medicaid Services Program Management Account from the Federal Supplementary Medical Insurance Trust Fund under section 1841 $5,000,000. (2) Care management fees and incentives For the purposes of payments under subsection (f), there shall be transferred to the Secretary such sums as are necessary from the Federal Supplementary Medical Insurance Trust Fund under section 1841 for each of fiscal years 2021 through 2025. (3) Availability Amounts transferred under this subsection for a fiscal year shall be available until expended. (j) Waivers The Secretary may waive any provision of this title that conflicts with or impedes the implementation of the provisions of this section. .

tv_txt: I 115th CONGRESS 2d Session H. R. 5605 IN THE HOUSE OF REPRESENTATIVES 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.

1. Short title This Act may be cited as the Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act . 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: 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. . 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. Karen L. Haas, Clerk.

tv_txt: IB Union Calendar No. 578 115th CONGRESS 2d Session H. R. 5605 [Report No. 115–744, Part I] IN THE HOUSE OF REPRESENTATIVES April 24, 2018 Mr. Ruiz introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Ways and Means , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned June 12, 2018 Additional sponsors: Mrs. Blackburn and Mr. Walden June 12, 2018 Reported from the Committee on Energy and Commerce with an amendment Strike out all after the enacting clause and insert the part printed in italic June 12, 2018 The Committee on Ways and Means discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed For text of introduced bill, see copy of bill as introduced on April 24, 2018 A BILL To amend title XVIII of the Social Security Act to provide for an opioid use disorder treatment demonstration program.

1. Short title This Act may be cited as the Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act . 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: 1866F. Opioid use disorder treatment demonstration program (a) Implementation of 5-year demonstration program (1) In general Not later than January 1, 2021, the Secretary shall implement a 5-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 physicians 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, for participation through the submission of data and information described in clause (iii); and (iii) submit to 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 with respect to the criteria established under subsection (e)(2)(A) and such other information as the Secretary determines appropriate to monitor and evaluate the Program, to determine if minimum criteria are met under clause (ii), and to determine the incentive payment under subsection (e), in such form, manner, and frequency as specified by the Secretary. (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 or advanced practice nurse, that— (i) is enrolled under section 1861(j); (ii) is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment; and (iii) has in effect a registration or 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. (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. (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) Submission of data Each participant shall submit to the Secretary, in such form, manner, and frequency specified by the Secretary, data with respect to such criteria described in subparagraph (A) and such other information as the Secretary determines appropriate to evaluate and monitor the effectiveness of the Program, to determine the performance of the participants for purposes of the incentive payment under subparagraph (A), and to ensure the participants meet minimum criteria for program participation described in subsection (c)(2)(B)(ii). (3) Non-duplication of payments In the case if an applicable beneficiary receiving services supported by the Program from more than one participant during any one calendar month, or from a participant and a provider who is not a participant during any one calendar month, the Secretary shall adjust (such as pro-rate) payment under paragraph (1) and any payment under paragraph (2) to each such participant, with respect to such applicable beneficiary and month to avoid any duplication of payment. (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)), the Secretary shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of $5,000,000 to the Centers for Medicare & Medicaid Services Program Management Account. (2) Care management fees and incentives For the purposes of making payments under subsection (e), the Secretary shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of $10,000,000 for each of fiscal years 2021 through 2025. (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. .

June 12, 2018 Reported from the Committee on Energy and Commerce with an amendment June 12, 2018 The Committee on Ways and Means discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed

tv_txt: IIB 115th CONGRESS 2d Session H. R. 5605 IN THE SENATE OF THE UNITED STATES June 20, 2018 Received; read twice and referred to the Committee on Finance 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.

1. Short title This Act may be cited as the Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act . 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: 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. . 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. Karen L. Haas, Clerk.