H.R. 5605 — what changed

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

changed “(a) Implementation of 5-Year 5-year demonstration program

changed “(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) (e) to participating care teams participants (as defined in subsection (c)(1)(A)) for providing 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 under in the Program.

“(2) Opioid use disorder treatment services—For purposes of this section, the term opioid use disorder treatment services—

changed “(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—setting; and

removed “(i) which are supported by the per applicable beneficiary per month care management fee under subsection (f); or

removed “(ii) for which payment may otherwise be made under this title; and

“(B) includes—

“(i) medication assisted treatment;

“(ii) treatment planning;

added “(iii) psychiatric, psychological, or counseling services (or any combination of such services), as appropriate;

added “(iv) social support services, as appropriate; and

changed “(iii) appropriate outpatient psychiatric, psychological, or counseling services (or any combination “(v) care management and care coordination services, including coordination with other providers of such services);services and suppliers not on an opioid use disorder care team.

removed “(iv) appropriate social support services; and

removed “(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

added “(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:

removed “(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.

added “(B) Increases use of medication-assisted treatment for opioid use disorders.

added “(C) Improves health outcomes of individuals with opioid use disorders, including by reducing the incidence of infectious diseases (such as hepatitis C and HIV).

changed “(B) Reduces “(D) Does not increase the occurrence of overdoses from opioids, including prescription opioid medications as well as illicit opioids.total spending on items and services under this title.

changed “(C) Increases use of medication-assisted treatment for “(E) Reduces deaths from opioid use disorders.overdose.

changed “(D) Improves health outcomes of individuals with opioid use disorders, including by reducing “(F) Reduces the incidence utilization of infectious diseases (such as hepatitis C and HIV).inpatient residential treatment.

changed “(E) Does not increase “(2) Consultation—In designing the total spending on health care services 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 title.section, consult with specialists in the field of addiction, clinicians in the primary care community, and beneficiary groups.

changed “(F) Reduces deaths from “(c) Participants; opioid poisoning.use disorder care teams

changed “(G) Reduces the utilization of inpatient residential treatment.“(1) Participants

changed “(2) Consultation—In designing the Program, the Secretary shall, not later than 3 months after the date of the enactment of “(A) Definition—In this section, consult with specialists in the field of addiction and clinicians in the primary care community.term participant means an entity or individual—

changed “(c) Participating care teams“(i) that is otherwise enrolled under this title and that is—

changed “(1) Definition; selection“(I) a physician (as defined in section 1861(r)(1);

changed “(A) Definition—In this section, the term participating care team means an opioid use disorder care team (as defined “(II) a group practice comprised of physicians described in paragraph (2)) that is participating under the Program pursuant to selection by the Secretary under subparagraph (B).subclause (I);

changed “(B) Selection—Under the Program, the Secretary shall provide for “(III) 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.hospital outpatient department;

changed “(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 “(IV) 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.federally qualified health center (as defined in section 1861(aa)(4));

added “(V) a rural health clinic (as defined in section 1861(aa)(2));

added “(VI) a community mental health center (as defined in section 1861(ff)(3)(B));

added “(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

added “(VIII) any other individual or entity specified by the Secretary;

added “(ii) that applied for and was selected to participate in the Program pursuant to an application and selection process established by the Secretary; and

added “(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

added “(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

removed “(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—

removed “(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);

removed “(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

removed “(iii) includes other practitioners—

removed “(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

removed “(II) who only perform services that such practitioners are legally authorized to perform under State law.

removed “(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—

changed “(i) deliver “(A) In general—For purposes of this section, the term opioid use disorder treatment services to applicable beneficiaries who agree to receive the services;care team means a team of health care practitioners established by a participant described in paragraph (1)(A) that—

changed “(ii) meet minimum standards for quality required by the Program; and“(i) shall include—

changed “(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 “(I) at least one physician (as defined in subsection (d) and such other information as the Secretary determines appropriate to monitor and evaluate the Program and section 1861(r)(1)) furnishing primary care services or addiction treatment services 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.an applicable beneficiary; and

added “(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

added “(ii) may include other practitioners licensed under State law to furnish psychiatric, psychological, counseling, and social services to applicable beneficiaries.

added “(B) Requirements for receipt of payment under Program—In order to receive payments under subsection (e), each participant in the Program shall—

added “(i) furnish opioid use disorder treatment services through opioid use disorder care teams to applicable beneficiaries who agree to receive the services;

added “(ii) meet minimum criteria, as established by the Secretary, for participation through the submission of data and information described in clause (iii); and

added “(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

removed “(A) Eligible practitioners—For purposes of this section, the term eligible practitioner means, with respect to an applicable beneficiary, a provider of services that—

removed “(i) participates in the Medicare program under this title;

removed “(ii)

removed “(I) is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment; and

removed “(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

removed “(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.

changed “(B) Addiction specialists—For “(A) Eligible practitioners—For purposes of paragraph (2)(C), this section, the term addiction specialist eligible practitioner means a physician that possesses expert knowledge and skills in addiction medicine, or other health care practitioner, such as evidenced by—a nurse practitioner or advanced practice nurse, that—

changed “(i) certification by the American Society of Addiction Medicine or the American Board of Addiction Medicine;is enrolled under section 1861(j);

changed “(ii) subspecialty certification in addiction medicine by the American Board of Preventive Medicine;is authorized to prescribe or dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment; and

changed “(iii) subspecialty certification has in addiction psychiatry 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 American Board of Psychiatry Substance Abuse and Neurology;Mental Health Services Administration to carry out such section.

changed “(iv) “(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 added advanced qualification in addiction medicine, or completion of an accredited residency or fellowship in addiction medicine conferred or addiction psychiatry, as determined by the American Osteopathic Association; orSecretary.

changed “(v) completion “(d) Participation of an accredited residency or fellowship in addiction medicine or addiction psychiatry.applicable beneficiaries

removed “(d) Quality and other reporting requirements

removed “(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:

removed “(A) Patient engagement in treatment.

removed “(B) Retention in treatment.

removed “(C) Provision of evidence-based medication-assisted treatment.

removed “(D) Any other criteria the Secretary deems appropriate.

removed “(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).

removed “(e) Participation of applicable beneficiaries

“(1) Applicable beneficiary defined—In this section, the term applicable beneficiary means an individual who—

added “(A) is entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B;

removed “(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;

added “(C) has a current diagnosis for an opioid use disorder; and

removed “(C) has a diagnosis for an opioid use disorder; and

“(D) meets such other criteria as the Secretary determines appropriate.

added “(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.

added “(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.

added “(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.

added “(e) Payments

removed “(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.

removed “(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.

removed “(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.

removed “(f) Payments

“(1) Per applicable beneficiary per month care management fee

added “(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.

added “(B) Payment amounts—In carrying out subparagraph (A), the Secretary shall—

added “(i) consider payments otherwise payable under this title for opioid use disorder treatment services and the needs of applicable beneficiaries;

added “(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;

added “(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;

added “(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

added “(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.

added “(2) Incentive payments

changed “(A) In general—The general—Under the Program, 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 performance-based incentive payment, which shall be paid to (using a participating care team in addition to any other amount otherwise payable under this title to the practitioners participating with methodology established and at a time determined appropriate by the team or, if applicable, Secretary) to participants based on the entity performance of participants with respect to such team employing or contracting criteria, as determined appropriate by the Secretary, in accordance 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.subparagraph (B).

changed “(B) Application—In carrying out subparagraph (A), the Secretary shall—Criteria

changed “(i) consider the costs that participating care teams are expected to incur In general—Criteria described in delivering high-quality opioid use disorder care services that are not covered by payments otherwise payable to subparagraph (A) may include consideration of the teams under this title;following:

changed “(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 “(I) Patient engagement and who is appropriate for such services based on clinical guidelines for opioid use disorder care;retention in treatment.

changed “(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“(II) Evidence-based medication-assisted treatment.

changed “(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.“(III) Other criteria established by the Secretary.

changed “(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 “(ii) Required consultation and assessment methods adopted or developed by consideration—In determining criteria described in subparagraph (A), the Secretary under subsection (d) and with respect to which the teams report under such subsection.shall—

changed “(g) Multipayer strategy—In carrying out the Program, “(I) consult with stakeholders, including clinicians in the Secretary shall encourage other payers to provide similar payments and to use similar quality standards primary care community and methods of assessment as applied under in the Program. The Secretary may enter into a memorandum field 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.addiction medicine; and

changed “(h) Evaluation“(II) consider existing clinical guidelines for the treatment of opioid use disorders.

changed “(1) In general—The Comptroller General “(C) Submission of the United States data—Each participant shall conduct an intermediate and final evaluation of submit to the program. Each Secretary, in such evaluation shall determine form, manner, and frequency specified by the extent Secretary, data with respect to which each of the purposes such criteria described in subsection (b) have been accomplished under the Program. Each evaluation shall also determine subparagraph (A) and such other information as the extent Secretary determines appropriate to which the structure evaluate and requirements monitor the effectiveness of the Program facilitated or impeded Program, to determine the participation performance of practitioners in the program, the participation participants for purposes of beneficiaries with opioid use disorder, the incentive payment under subparagraph (A), and to ensure the delivery of high-quality opioid use disorder treatment services.participants meet minimum criteria for program participation described in subsection (c)(2)(B)(ii).

changed “(2) Reports—The Comptroller General “(3) Non-duplication of payments—In the United States shall submit to 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 Congress—any payment under paragraph (2) to each such participant, with respect to such applicable beneficiary and month to avoid any duplication of payment.

added “(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.

added “(g) Evaluation

added “(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.

added “(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.

added “(h) Funding

added “(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.

added “(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.

removed “(i) Funding

removed “(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.

removed “(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.

added “(i) Waivers—The Secretary may waive any provision of this title as may be necessary to carry out the Program under this section.”

removed “(j) Waivers—The Secretary may waive any provision of this title that conflicts with or impedes the implementation of the provisions of this section.”