H.R. 6 — what changed

added “(84) provide that—

added “(A) the State shall not terminate eligibility for medical assistance under the State plan for an individual who is an eligible juvenile (as defined in subsection (nn)(2)) because the juvenile is an inmate of a public institution (as defined in subsection (nn)(3)), but may suspend coverage during the period the juvenile is such an inmate;

added “(B) in the case of an individual who is an eligible juvenile described in paragraph (2)(A) of subsection (nn), the State shall, prior to the individual’s release from such a public institution, conduct a redetermination of eligibility for such individual with respect to such medical assistance (without requiring a new application from the individual) and, if the State determines pursuant to such redetermination that the individual continues to meet the eligibility requirements for such medical assistance, the State shall restore coverage for such medical assistance to such an individual upon the individual’s release from such public institution; and

added “(C) in the case of an individual who is an eligible juvenile described in paragraph (2)(B) of subsection (nn), the State shall process any application for medical assistance submitted by, or on behalf of, such individual such that the State makes a determination of eligibility for such individual with respect to such medical assistance upon release of such individual from such public institution.”

added “(nn) Juvenile; eligible juvenile; public institution—For purposes of subsection (a)(84) and this subsection:

added “(1) Juvenile—The term juvenile means an individual who is—

added “(A) under 21 years of age; or

added “(B) described in subsection (a)(10)(A)(i)(IX).

added “(2) Eligible juvenile—The term eligible juvenile means a juvenile who is an inmate of a public institution and who—

added “(A) was determined eligible for medical assistance under the State plan immediately before becoming an inmate of such a public institution; or

added “(B) is determined eligible for such medical assistance while an inmate of a public institution.

added “(3) Inmate of a public institution—The term inmate of a public institution has the meaning given such term for purposes of applying the subdivision (A) following paragraph (29) of section 1905(a), taking into account the exception in such subdivision for a patient of a medical institution.”

added Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended by adding at the end the following new subsection:

added “(aa) Demonstration project to increase substance use provider capacity

added “(1) In general—Not later than the date that is 180 days after the date of the enactment of this section, the Secretary shall, in consultation, as appropriate, with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, conduct a 54-month demonstration project for the purpose described in paragraph (2) under which the Secretary shall—

added “(A) for the first 18-month period of such project, award planning grants described in paragraph (3); and

added “(B) for the remaining 36-month period of such project, provide to each State selected under paragraph (4) payments in accordance with paragraph (5).

added “(2) Purpose—The purpose described in this paragraph is for each State selected under paragraph (4) to increase the treatment capacity of providers participating under the State plan (or a waiver of such plan) to provide substance use disorder treatment or recovery services under such plan (or waiver) through the following activities:

added “(A) For the purpose described in paragraph (3)(C)(i), activities that support an ongoing assessment of the behavioral health treatment needs of the State, taking into account the matters described in subclauses (I) through (IV) of such paragraph.

added “(B) Activities that, taking into account the results of the assessment described in subparagraph (A), support the recruitment, training, and provision of technical assistance for providers participating under the State plan (or a waiver of such plan) that offer substance use disorder treatment or recovery services.

added “(C) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that—

added “(i) are authorized to dispense drugs approved by the Food and Drug Administration for individuals with a substance use disorder who need withdrawal management or maintenance treatment for such disorder;

added “(ii) have in effect a registration or waiver under section 303(g) of the Controlled Substances Act for purposes of dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment and are in compliance with any regulation promulgated by the Assistant Secretary for Mental Health and Substance Use for purposes of carrying out the requirements of such section 303(g); and

added “(iii) are qualified under applicable State law to provide substance use disorder treatment or recovery services.

added “(D) Improved reimbursement for and expansion of, through the provision of education, training, and technical assistance, the number or treatment capacity of providers participating under the State plan (or waiver) that have the qualifications to address the treatment or recovery needs of—

added “(i) individuals enrolled under the State plan (or a waiver of such plan) who have neonatal abstinence syndrome, in accordance with guidelines issued by the American Academy of Pediatrics and American College of Obstetricians and Gynecologists relating to maternal care and infant care with respect to neonatal abstinence syndrome;

added “(ii) pregnant women, postpartum women, and infants, particularly the concurrent treatment, as appropriate, and comprehensive case management of pregnant women, post­partum women and infants, enrolled under the State plan (or a waiver of such plan);

added “(iii) adolescents and young adults between the ages of 12 and 21 enrolled under the State plan (or a waiver of such plan); or

added “(iv) American Indian and Alaska Native individuals enrolled under the State plan (or a waiver of such plan).

added “(3) Planning grants

added “(A) In general—The Secretary shall, with respect to the first 18-month period of the demonstration project conducted under paragraph (1), award planning grants to at least 10 States selected in accordance with subparagraph (B) for purposes of preparing an application described in paragraph (4)(C) and carrying out the activities described in subparagraph (C).

added “(B) Selection—In selecting States for purposes of this paragraph, the Secretary shall—

added “(i) select States that have a State plan (or waiver of the State plan) approved under this title;

added “(ii) select States in a manner that ensures geographic diversity; and

added “(iii) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate.

added “(C) Activities described—Activities described in this subparagraph are, with respect to a State, each of the following:

added “(i) Activities that support the development of an initial assessment of the behavioral health treatment needs of the State to determine the extent to which providers are needed (including the types of such providers and geographic area of need) to improve the network of providers that treat substance use disorders under the State plan (or waiver), including the following:

added “(I) An estimate of the number of individuals enrolled under the State plan (or a waiver of such plan) who have a substance use disorder.

added “(II) Information on the capacity of providers to provide substance use disorder treatment or recovery services to individuals enrolled under the State plan (or waiver), including information on providers who provide such services and their participation under the State plan (or waiver).

added “(III) Information on the gap in substance use disorder treatment or recovery services under the State plan (or waiver) based on the information described in subclauses (I) and (II).

added “(IV) Projections regarding the extent to which the State participating under the demonstration project would increase the number of providers offering substance use disorder treatment or recovery services under the State plan (or waiver) during the period of the demonstration project.

added “(ii) Activities that, taking into account the results of the assessment described in clause (i), support the development of State infrastructure to, with respect to the provision of substance use disorder treatment or recovery services under the State plan (or a waiver of such plan), recruit prospective providers and provide training and technical assistance to such providers.

added “(D) Funding—For purposes of subparagraph (A), there is appropriated, out of any funds in the Treasury not otherwise appropriated, $50,000,000, to remain available until expended.

added “(4) Post-planning States

added “(A) In general—The Secretary shall, with respect to the remaining 36-month period of the demonstration project conducted under paragraph (1), select not more than 5 States in accordance with subparagraph (B) for purposes of carrying out the activities described in paragraph (2) and receiving payments in accordance with paragraph (5).

added “(B) Selection—In selecting States for purposes of this paragraph, the Secretary shall—

added “(i) select States that received a planning grant under paragraph (3);

added “(ii) select States that submit to the Secretary an application in accordance with the requirements in subparagraph (C), taking into consideration the quality of each such application;

added “(iii) select States in a manner that ensures geographic diversity; and

added “(iv) give preference to States with a prevalence of substance use disorders (in particular opioid use disorders) that is comparable to or higher than the national average prevalence, as measured by aggregate per capita drug overdoses, or any other measure that the Secretary deems appropriate.

added “(C) Applications

added “(i) In general—A State seeking to be selected for purposes of this paragraph shall submit to the Secretary, at such time and in such form and manner as the Secretary requires, an application that includes such information, provisions, and assurances, as the Secretary may require, in addition to the following:

added “(I) A proposed process for carrying out the ongoing assessment described in paragraph (2)(A), taking into account the results of the initial assessment described in paragraph (3)(C)(i).

added “(II) A review of reimbursement methodologies and other policies related to substance use disorder treatment or recovery services under the State plan (or waiver) that may create barriers to increasing the number of providers delivering such services.

added “(III) The development of a plan, taking into account activities carried out under paragraph (3)(C)(ii), that will result in long-term and sustainable provider networks under the State plan (or waiver) that will offer a continuum of care for substance use disorders. Such plan shall include the following:

added “(aa) Specific activities to increase the number of providers (including providers that specialize in providing substance use disorder treatment or recovery services, hospitals, health care systems, Federally qualified health centers, and, as applicable, certified community behavioral health clinics) that offer substance use disorder treatment, recovery, or support services, including short-term detoxification services, outpatient substance use disorder services, and evidence-based peer recovery services.

added “(bb) Strategies that will incentivize providers described in subparagraphs (C) and (D) of paragraph (2) to obtain the necessary training, education, and support to deliver substance use disorder treatment or recovery services in the State.

added “(cc) Milestones and timeliness for implementing activities set forth in the plan.

added “(dd) Specific measurable targets for increasing the substance use disorder treatment and recovery provider network under the State plan (or a waiver of such plan).

added “(IV) A proposed process for reporting the information required under paragraph (6)(A), including information to assess the effectiveness of the efforts of the State to expand the capacity of providers to deliver substance use disorder treatment or recovery services during the period of the demonstration project under this subsection.

added “(V) The expected financial impact of the demonstration project under this subsection on the State.

added “(VI) A description of all funding sources available to the State to provide substance use disorder treatment or recovery services in the State.

added “(VII) A preliminary plan for how the State will sustain any increase in the capacity of providers to deliver substance use disorder treatment or recovery services resulting from the demonstration project under this subsection after the termination of such demonstration project.

added “(VIII) A description of how the State will coordinate the goals of the demonstration project with any waiver granted (or submitted by the State and pending) pursuant to section 1115 for the delivery of substance use services under the State plan, as applicable.

added “(ii) Consultation—In completing an application under clause (i), a State shall consult with relevant stakeholders, including Medicaid managed care plans, health care providers, and Medicaid beneficiary advocates, and include in such application a description of such consultation.

added “(5) Payment

added “(A) In general—For each quarter occurring during the period for which the demonstration project is conducted (after the first 18 months of such period), the Secretary shall pay under this subsection, subject to subparagraph (C), to each State selected under paragraph (4) an amount equal to 80 percent of so much of the qualified sums expended during such quarter.

added “(B) Qualified sums defined—For purposes of subparagraph (A), the term qualified sums means, with respect to a State and a quarter, the amount equal to the amount (if any) by which the sums expended by the State during such quarter attributable to substance use treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan) exceeds 1/4 of such sums expended by the State during fiscal year 2018 attributable to substance use treatment or recovery services.

added “(C) Non-duplication of payment—In the case that payment is made under subparagraph (A) with respect to expenditures for substance use treatment or recovery services furnished by providers participating under the State plan (or a waiver of such plan), payment may not also be made under subsection (a) with respect to expenditures for the same services so furnished.

added “(6) Reports

added “(A) State reports—A State receiving payments under paragraph (5) shall, for the period of the demonstration project under this subsection, submit to the Secretary a quarterly report, with respect to expenditures for substance use treatment or recovery services for which payment is made to the State under this subsection, on the following:

added “(i) The specific activities with respect to which payment under this subsection was provided.

added “(ii) The number of providers that delivered substance use disorder treatment or recovery services in the State under the demonstration project compared to the estimated number of providers that would have otherwise delivered such services in the absence of such demonstration project.

added “(iii) The number of individuals enrolled under the State plan (or a waiver of such plan) who received substance use disorder treatment or recovery services under the demonstration project compared to the estimated number of such individuals who would have otherwise received such services in the absence of such demonstration project.

added “(iv) Other matters as determined by the Secretary.

added “(B) CMS reports

added “(i) Initial report—Not later than October 1, 2020, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an initial report on—

added “(I) the States awarded planning grants under paragraph (3);

added “(II) the criteria used in such selection; and

added “(III) the activities carried out by such States under such planning grants.

added “(ii) Interim report—Not later than October 1, 2022, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress an interim report—

added “(I) on activities carried out under the demonstration project under this subsection;

added “(II) on the extent to which States selected under paragraph (4) have achieved the stated goals submitted in their applications under subparagraph (C) of such paragraph;

added “(III) with a description of the strengths and limitations of such demonstration project; and

added “(IV) with a plan for the sustainability of such project.

added “(iii) Final report—Not later than October 1, 2024, the Administrator of the Centers for Medicare & Medicaid Services shall, in consultation with the Director of the Agency for Healthcare Research and Quality and the Assistant Secretary for Mental Health and Substance Use, submit to Congress a final report—

added “(I) providing updates on the matters reported in the interim report under clause (ii);

added “(II) including a description of any changes made with respect to the demonstration project under this subsection after the submission of such interim report; and

added “(III) evaluating such demonstration project.

added “(C) AHRQ report—Not later than 3 years after the date of the enactment of this subsection, the Director of the Agency for Healthcare Research and Quality, on consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall submit to Congress a summary on the experiences of States awarded planning grants under paragraph (3) and States selected under paragraph (4).

added “(7) Data sharing and best practices—During the period of the demonstration project under this subsection, the Secretary shall, in collaboration with States selected under paragraph (4), facilitate data sharing and the development of best practices between such States and States that were not so selected.

added “(8) CMS funding—There is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 to the Centers for Medicare & Medicaid Services for purposes of implementing this subsection. Such amount shall remain available until expended.”

added “1927A. Drug management program for at-risk beneficiaries

added “(a) In general—Beginning January 1, 2020, a State shall operate a qualified drug management program under which a State may enroll certain at-risk beneficiaries identified by the State under the program.

added “(b) Qualified drug management program—For purposes of this section, the term qualified drug management program means, with respect to a State, a program carried out by the State (including through a contract with a pharmacy benefit manager) that provides at least for the following:

added “(1) Identification of at-risk individuals—Under the program, the State identifies, in accordance with subsection (c), individuals enrolled under the State plan (or waiver of the State plan) who are at-risk beneficiaries.

added “(2) Elements of program

added “(A) In general—Under the program, the State, with respect to each individual identified under paragraph (1) and enrolled under the program under paragraph (5)—

added “(i) subject to subparagraphs (B) and (C), selects at least one, but not more than three, health care providers and at least one, but not more than three, pharmacies for each such individual for purposes of clause (ii), in accordance with a selection process that takes into account reasonable factors such as the individual’s previous utilization of items and services from health care providers and pharmacies, geographic proximity of the individual to such health care providers and pharmacies, access of the individual to health care, reasonable travel time, information regarding housing status, and any known preference of the individual for a certain health care provider or pharmacy; and

added “(ii) requires that any controlled substance furnished to such individual during the period for which such individual is enrolled under the program be prescribed by a health care provider selected under clause (i) for such individual and dispensed by a pharmacy selected under clause (i) for such individual in order for such controlled substance to be covered under the State plan (or waiver).

added “(B) Beneficiary preference—In the case of an individual receiving a notice under paragraph (3)(A) of being identified as potentially being an at-risk beneficiary described in such paragraph, such individual may submit, during the 30-day period following receipt of such notice, preferences for which health care providers and pharmacies the individual would prefer the State to select under subparagraph (A). The State shall select or change the selection of health care providers and pharmacies under subparagraph (A) for the individuals based on such preferences, except that in the case that State determines that such selection (or change of selection) of a health care provider or pharmacy under subparagraph (A) is contributing or would contribute to prescription drug abuse or drug diversion by the individual, the State may select or change the selection of health care provider or pharmacy for the individual without regard to the preferences of the individual described in this subparagraph. If the State selects or changes the selection pursuant to the preceding sentence without regard to the preferences of the individual, the State shall provide the individual with at least 30 days written notice of the selection or change of selection and a rationale for the selection or change.

added “(C) Treatment of pharmacy with multiple locations—For purposes of subparagraph (A)(i), in the case of a pharmacy that has multiple locations that share real-time electronic prescription data, all such locations of the pharmacy shall collectively be treated as one pharmacy.

added “(D) Treatment of existing FFS drug management programs—In the case of a patient review and restriction program (as identified in the annual report submitted to the Secretary under section 1927(g)(3)(D)) operated by a State pursuant to section 1915(a)(2) before the date of the enactment of this section, such program shall be treated as a qualified drug management program.

added “(E) Reasonable access—The program shall ensure, including through waiver of elements of the program (including under subparagraph (A)(ii)), reasonable access to health care (including access to health care providers and pharmacies with respect to prescription drugs described in subparagraph (A)) in the case of individuals with multiple residences, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)).

added “(3) Notification to identified individuals—Under the program, the State provides each individual who is identified under paragraph (1), prior to enrolling such individual under the program, at least one notification of each of the following:

added “(A) Notice that the State has identified the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance.

added “(B) The name, address, and contact information of each health care provider and pharmacy that may be selected for the individual under paragraph (2)(A).

added “(C) Information describing all State and Federal public health resources that are designed to address such abuse or misuse to which the individual has access, including mental health services, substance use disorder and recovery services, and other counseling services.

added “(D) Notice of, and information about, the right of the individual to—

added “(i) submit preferences of the individual for health care providers and pharmacies to be selected under paragraph (2)(A), including as described in paragraph (2)(B);

added “(ii) appeal under paragraph (4)—

added “(I) such identification described in subparagraph (A); and

added “(II) the selection of health care providers and pharmacies under paragraph (2)(A).

added “(E) An explanation of the meaning and consequences of the identification of the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance, including an explanation of the program.

added “(F) Information, including a contact list and clear instructions, that explain how the individual can contact the appropriate entities administering the program in order to submit preferences described in paragraph (2)(B) and any other communications relating to the program.

added “(4) Appeals process—Under the program, the State provides for an appeals process under which, with respect to an individual identified under paragraph (1)—

added “(A) such individual may appeal—

added “(i) such identification; and

added “(ii) the selection of a health care provider or pharmacy under paragraph (2)(A);

added “(B) in the case of an appeal described in subparagraph (A)(ii), the State shall accommodate the health care provider or pharmacy preferred by the individual for selection for purposes of paragraph (2)(A), unless the State determines that a change to the selection of health care provider or pharmacy under such paragraph is contributing or would contribute to prescription drug abuse or drug diversion by the individual;

added “(C) such individual is provided a period of not less than 30 days following the date of receipt of the notice described in paragraph (3) to submit such appeal; and

added “(D) the State must make a determination with respect to an appeal described in subparagraph (A), and notify the individual of such determination, prior to enrollment of such individual in the program.

added “(5) Enrollment—Under the program, the State initially enrolls individuals who are identified under paragraph (1) in the program for a 12-month period—

added “(A) in the case of such an individual who does not submit an appeal under paragraph (4) within the period applied by the State pursuant to subparagraph (C) of such paragraph, beginning on the day after the last day of such period; and

added “(B) in the case of such an individual who does submit an appeal under paragraph (4) within the period applied by the State pursuant to subparagraph (C) of such paragraph but such appeal is denied, beginning not later than 30 days after the date of such denial.

added “(6) Notification of health care providers and pharmacies—Under the program, the State provides to each health care provider and pharmacy selected for an individual under paragraph (2)—

added “(A) notification that the individual is an at-risk beneficiary enrolled under the program and that the provider or pharmacy has been selected for the individual under paragraph (2);

added “(B) information on such program and the role of being so selected; and

added “(C) a process through which the provider or pharmacy can submit a concern or complaint with respect to being so selected.

added “(7) Continuation of enrollment—Under the program, the State, with respect to an individual enrolled under the program, provides for a process to—

added “(A) not later than 30 days before the end of the 12-month period for which the individual is so enrolled pursuant to paragraph (5)—

added “(i) assess, in accordance with publicly available evidence-based guidelines, whether or not such individual should continue to be enrolled under the program; and

added “(ii) notify such individual of the results of the assessment under clause (i);

added “(B) continue, subject to subparagraph (C), enrollment of such individual if such assessment recommends such continuation; and

added “(C) appeal the continuation of enrollment in accordance with the appeals process described in paragraph (4).

added “(c) At-Risk beneficiary

added “(1) Identification—For purposes of this section, a State shall identify an individual enrolled under the State plan (or waiver of the State plan) as an at-risk beneficiary if the individual is not an exempted individual described in paragraph (2) and—

added “(A) is identified as such an at-risk beneficiary through the use of publicly available evidence-based guidelines that indicate misuse or abuse of a controlled substance; or

added “(B) the State received notification from a PDP sponsor or Medicare Advantage organization that such individual was identified as being an at-risk beneficiary for prescription drug abuse for enrollment in a drug management program established by the sponsor or organization pursuant to section 1860D–4(c)(5) and such identification has not been terminated under subparagraph (F) of such section.

added “(2) Exempted individual described—For purposes of paragraph (1), an exempted individual described in this paragraph is an individual who—

added “(A) is receiving—

added “(i) hospice or palliative care; or

added “(ii) treatment for cancer;

added “(B) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or

added “(C) the State elects to treat as an exempted individual for purposes of paragraph (1).

added “(d) Application of privacy rules clarification—The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b)(6) in the same manner as the Secretary is required under subparagraph (J) of section 1860D–4(c)(5) to clarify privacy requirements related to the sharing of data described in such subparagraph.

added “(e) Reports

added “(1) Annual reports—A State operating a qualified drug management program shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D), beginning with such reports submitted for 2021, the following information:

added “(A) The number of individuals enrolled under the State plan (or waiver of the State plan) who are enrolled under the program and the percentage of individuals enrolled under the State plan (or waiver) who are enrolled under such program.

added “(B) The number of prescriptions for controlled substances that were dispensed per month during each such year per individual enrolled under the program, including the daily morphine milligram equivalents and the quantity prescribed for each such prescription.

added “(C) The number of pharmacies filling prescriptions for controlled substances for individuals enrolled under such program.

added “(D) The number of health care providers writing prescriptions for controlled substances (other than prescriptions for a refill) for individuals enrolled under such program.

added “(E) Any other data that the Secretary may require.

added “(F) Any report submitted by a managed care entity under subsection (f)(1)(B) with respect to the year involved.

added “(2) MACPAC reports and review—Not later than 2 years after the date of the enactment of this section, the Medicaid and CHIP Payment and Access Commission (in this section referred to as “MACPAC”), in consultation with the National Association of Medicaid Directors, pharmacy benefit managers, managed care organizations, health care providers (including pharmacists), beneficiary advocates, and other stakeholders, shall publish a report that includes—

added “(A) best practices for operating drug management programs, based on a review of a representative sample of States administering such a program;

added “(B) a summary of the experience of the appeals process under drug management programs operated by several States, such as the frequency at which individuals appealed the identification of being an at-risk individual, the frequency at which individuals appealed the selection of a health care provider or pharmacy under such a program, the timeframes for such appeals, a summary of the reasons for such appeals, and the design of such appeals processes;

added “(C) a summary of trends and the effectiveness of qualified drug management programs operated under this section; and

added “(D) recommendations to States on how improvements can be made with respect to the operation of such programs.

added “(3) Report on plan for coordinated care—Not later than January 1, 2021, each State operating a qualified drug management program shall submit to the Administrator of the Centers for Medicare & Medicaid Services a report on how such State plans to provide coordinated care for individuals enrolled under the State plan (or waiver of the State plan) and—

added “(A) who are enrolled under the program; or

added “(B) who are enrolled with a managed care entity and enrolled under such a qualified drug management program operated by such entity.

added “(f) Applicability to managed care entities

added “(1) In general—With respect to any contract that a State enters into on or after January 1, 2020, with a managed care entity (as defined in section 1932(a)(1)(B)) pursuant to section 1903(m), the State shall, as a condition of the contract, require the managed care entity—

added “(A) to operate a qualified drug management program (as defined in subsection (b)) for at-risk beneficiaries who are enrolled with such entity and identified by the managed care entity by means of application of paragraph (2);

added “(B) to submit to the State an annual report on the matters described in subparagraphs (A) through (E) of subsection (e)(1); and

added “(C) to submit to the State a list (and as necessary update such list) of individuals enrolled with such entity under the qualified drug management program operated by such entity under subparagraph (A) for purposes of allowing State plans for which medical assistance is paid on a fee-for-service basis to have access to such information.

added “(2) Application—For purposes of applying, with respect to a managed care entity—

added “(A) under paragraph (1)(A)—

added “(i) the definition of the term qualified drug management program under subsection (b), other than paragraph (2)(D) of such subsection; and

added “(ii) the provisions of paragraphs (1) and (2) of subsection (c); and

added “(B) under paragraph (1)(B), the report requirements described in subparagraphs (A) through (E) of subsection (e)(1);

added “(g) Controlled substance defined—For purposes of this section, the term controlled substance means a drug that is included in schedule II, III, or IV of section 202(c) of the Controlled Substances Act, or any combination thereof, as specified by the State.”

added “(85) provide that the State is in compliance with the drug review and utilization requirements under subsection (oo)(1).”

added “(oo) Drug review and utilization requirements

added “(1) In general—For purposes of subsection (a)(85), the drug review and utilization requirements under this subsection are, subject to paragraph (3) and beginning October 1, 2019, the following:

added “(A) Claims review limitations

added “(i) In general—The State has in place—

added “(I) safety edits (as specified by the State) for subsequent fills for opioids and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the State plan (or under a waiver of the State plan) is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the State;

added “(II) safety edits (as specified by the State) on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the State plan (or under a waiver of the State plan) for treatment of chronic pain and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the plan (or waiver) is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the State; and

added “(III) a claims review automated process (as designed and implemented by the State) that monitors when an individual enrolled under the State plan (or under a waiver of the State plan) is concurrently prescribed opioids and—

added “(aa) benzodiazepines; or

added “(bb) antipsychotics.

added “(ii) Managed care entities—The State requires each managed care entity (as defined in section 1932(a)(1)(B)) with respect to which the State has a contract under section 1903(m) or under section 1905(t)(3) to have in place, subject to paragraph (3), with respect to individuals who are eligible for medical assistance under the State plan (or under a waiver of the State plan) and who are enrolled with the entity, the limitations described in subclauses (I) and (II) of clause (i) and a claims review automated process described in subclause (III) of such clause.

added “(iii) Rules of construction—Nothing in this subparagraph may be construed as prohibiting a State or managed care entity from designing and implementing a claims review automated process under this subparagraph that provides for prospective or retrospective reviews of claims. Nothing in this subparagraph shall be understood as prohibiting the exercise of clinical judgment from a provider enrolled as a participating provider in a State plan (or waiver of the State plan) or contracting with a managed care entity regarding the best items and services for an individual enrolled under such State plan (or waiver).

added “(B) Program to monitor antipsychotic medications by children—The State has in place a program (as designed and implemented by the State) to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the State plan (or under a waiver of the State plan) and submits annually to the Secretary such information as the Secretary may require on activities carried out under such program for individuals not more than the age of 18 years generally and children in foster care specifically.

added “(C) Fraud and abuse identification—The State has in place a process (as designed and implemented by the State) that identifies potential fraud or abuse of controlled substances by individuals enrolled under the State plan (or under a waiver of the State plan), health care providers prescribing drugs to individuals so enrolled, and pharmacies dispensing drugs to individuals so enrolled.

added “(D) Reports—The State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D) information on the limitations, requirement, program, and processes applied by the State under subparagraphs (A) through (C) in accordance with such manner and time as specified by the Secretary.

added “(E) Clarification—Nothing shall prevent a State from satisfying the requirement—

added “(i) described in subparagraph (A) by having safety edits or a claims review automated process described in such subparagraph that was in place before October 1, 2019;

added “(ii) described in subparagraph (B) by having a program described in such subparagraph that was in place before such date; or

added “(iii) described in subparagraph (C) by having a process described in such subparagraph that was in place before such date.

added “(2) Annual report by Secretary—For each fiscal year beginning with fiscal year 2020, the Secretary shall submit to Congress a report on the most recent information submitted by States under paragraph (1)(D).

added “(3) Exceptions

added “(A) Certain individuals exempted—The drug review and utilization requirements under this subsection shall not apply with respect to an individual who—

added “(i) is receiving—

added “(I) hospice or palliative care; or

added “(II) treatment for cancer;

added “(ii) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or

added “(iii) the State elects to treat as exempted from such requirements.

added “(B) Exception relating to ensuring access—In order to ensure reasonable access to health care, the Secretary shall waive the drug review and utilization requirements under this subsection, with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)).”

added “(i) Drug utilization review activities and requirements—Beginning not later than October 1, 2019, each contract under a State plan with a managed care entity (other than a primary care case manager) under section 1903(m) shall provide that the entity is in compliance with the applicable provisions of section 438.3(s)(2) of title 42 of the Code of Federal Regulations, section 483.3(s)(4)) of such title, and section 483.3(s)(5) of such title, as such provisions were in effect on March 31, 2018.”

added “(4) Special rule relating to substance use disorder health homes

added “(A) In general—In the case of a State with an SUD-focused State plan amendment approved by the Secretary on or after October 1, 2018, the Secretary may, at the request of the State, extend the application of the Federal medical assistance percentage described in paragraph (1) to payments for the provision of health home services to SUD-eligible individuals under such State plan amendment, in addition to the first 8 fiscal year quarters the State plan amendment is in effect, for the subsequent 2 fiscal year quarters that the State plan amendment is in effect. Nothing in this section shall be construed as prohibiting a State with a State plan amendment that is approved under this section and that is not an SUD-focused State plan amendment from additionally having approved on or after such date an SUD-focused State plan amendment under this section, including for purposes of application of this paragraph.

added “(B) Report requirements—In the case of a State with an SUD-focused State plan amendment for which the application of the Federal medical assistance percentage has been extended under subparagraph (A), such State shall, at the end of the period of such State plan amendment, submit to the Secretary a report on the following, with respect to SUD-eligible individuals provided health home services under such State plan amendment:

added “(i) The quality of health care provided to such individuals, with a focus on outcomes relevant to the recovery of each such individual.

added “(ii) The access of such individuals to health care.

added “(iii) The total expenditures of such individuals for health care.

added “(C) Best practices—Not later than October 1, 2020, the Secretary shall make publicly available on the Internet website of the Centers for Medicare & Medicaid Services best practices for designing and implementing an SUD-focused State plan amendment, based on the experiences of States that have State plan amendments approved under this section that include SUD-eligible individuals.

added “(D) Definitions—For purposes of this paragraph:

added “(i) SUD-eligible individuals—The term “SUD-eligible individual” means, with respect to a State, an individual who satisfies all of the following:

added “(I) The individual is an eligible individual with chronic conditions.

added “(II) The individual is an individual with a substance use disorder.

added “(III) The individual has not previously received health home services under any other State plan amendment approved for the State under this section by the Secretary.

added “(ii) SUD-focused State plan amendment—The term “SUD-focused State plan amendment” means a State plan amendment under this section that is designed to provide health home services primarily to SUD-eligible individuals.”

added “(29) subject to paragraph (2) of subsection (ee), for the period beginning October 1, 2020, and ending September 30, 2025, medication-assisted treatment (as defined in paragraph (1) of such subsection); and”

added “(ee) Medication-assisted treatment

added “(1) Definition—For purposes of subsection (a)(29), the term “medication-assisted treatment”—

added “(A) means all drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), including methadone, and all biological products licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) to treat opioid use disorders; and

added “(B) includes, with respect to the provision of such drugs and biological products, counseling services and behavioral therapy.

added “(2) Exception—The provisions of paragraph (29) of subsection (a) shall not apply with respect to a State for the period specified in such paragraph, if before the beginning of such period the State certifies to the satisfaction of the Secretary that implementing such provisions statewide for all individuals eligible to enroll in the State plan (or waiver of the State plan) would not be feasible by reason of a shortage of qualified providers of medication-assisted treatment, or facilities providing such treatment, that will contract with the State or a managed care entity with which the State has a contract under section 1903(m) or under section 1905(t)(3).”

added Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—

added “(7) Authority not to apply certain requirements in the case of certain treatment of substance use disorder or co-occurring mental health disorder

added “(A) In general—For purposes of payment under this subsection, in the case of telehealth services described in subparagraph (C) furnished on or after January 1, 2020, to an eligible beneficiary (as defined in subparagraph (F)) for the treatment of a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder, the Secretary is authorized to, through rulemaking, not apply any of the requirements described in subparagraph (B).

added “(B) Requirements described—For purposes of this paragraph, the requirements described in this subparagraph are any of the following:

added “(i) Qualifications for an originating site under paragraph (4)(C)(ii).

added “(ii) Geographic limitations under paragraph (4)(C)(i).

added “(C) Telehealth services described—For purposes of this paragraph, the telehealth services described in this subparagraph are services that are both telehealth services (as described in paragraph (4)(F)) and identified by the Secretary, through rulemaking, as services that are the most commonly furnished (as defined by the Secretary) under this part to individuals diagnosed with a substance use disorder or a mental health disorder that is co-occurring with a substance use disorder.

added “(D) Clarification—Nothing in this paragraph shall be construed as limiting or otherwise affecting the authority of the Secretary to limit or eliminate the non-application pursuant to this paragraph of any of the requirements under subparagraph (B).

added “(E) Treatment of originating site facility fee—No facility fee shall be paid under paragraph (2)(B) to an originating site with respect to a telehealth service described in subparagraph (B) for which payment is made under this subsection by reason of the non-application of a requirement described in subparagraph (B) pursuant to this paragraph if payment for such service would not otherwise be permitted under this subsection if such requirement were applied.

added “(F) Eligible beneficiary defined—For purposes of this paragraph, the term eligible beneficiary means an individual who—

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

added “(ii) has a diagnosis for a substance use disorder; and

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

added “(G) Report—Not later than 5 years after the date of the enactment of this paragraph, the Secretary shall submit to Congress a report on the impact of any non-application under this paragraph of any of the requirements described in subparagraph (B) on

added “(i) the utilization of health care services related to substance use disorder, such as behavioral health services and emergency department visits; and

added “(ii) health outcomes related to substance use disorder, such as substance use overdose deaths.

added “(H) Funding—For purposes of carrying out this paragraph, in addition to funds otherwise available, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $3,000,000 to the Centers for Medicare & Medicaid Services Program Management Account to remain available until expended.

added “(8) Rule of construction—Nothing in this subsection may be construed as waiving requirements under this title to comply with applicable State law, including State licensure requirements.”

added Section 1833(t)(6) of the Social Security Act (42 U.S.C. 1395l(t)(6)) is amended—

added “(J) Eligible non-opioid analgesic defined—In this paragraph, the term eligible non-opioid analgesic means a drug or biological—

added “(i) that is an analgesic that is not an opioid;

added “(ii) that demonstrated substantial clinical improvement, as determined by the Secretary; and

added “(iii) for which payment—

added “(I) as an outpatient hospital service under this part was not being made as of the date of the enactment of this subparagraph; or

added “(II) was being made under this paragraph as of such date.”

added “(4)

added “(A) For purposes of paragraph (1), the term a review of current opioid prescriptions and screening for opioid use disorder means, with respect to an individual—

added “(i) a review by a physician or qualified non-physician practitioner of all current prescriptions of the individual; and

added “(ii) in the case of an individual determined by the review of a physician or qualified non-physician practitioner under subparagraph (A) to have a current prescription for opioids for chronic pain that has been prescribed for a minimum period of time (as specified by the Secretary)—

added “(I) a review by the physician or practitioner of the potential risk factors to the individual for opioid use disorder;

added “(II) an evaluation by the physician or practitioner of pain of the individual;

added “(III) the provision of information regarding non-opioid treatment options for the treatment and management of any chronic pain of the individual; and

added “(IV) if determined necessary by the physician or practitioner based on the results of the review and evaluation conducted as described in this paragraph, an appropriate referral by the physician or practitioner for additional treatment.

added “(B) For purposes of this paragraph, the term qualified non-physician practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist.”

added “(F)

added “(i) With respect to a targeted procedure (as defined in clause (ii)) furnished during 2020 or a subsequent year (before 2024) to an individual in an ambulatory surgical center, the payment amount for such procedure that would otherwise be determined under the revised payment system under subparagraph (D), without application of this subparagraph, shall be equal to the payment amount for such procedure furnished in 2016.

added “(ii) For purposes of clause (i), the term “targeted procedure” means a procedure to which Healthcare Common Procedure Coding System code 62310 (or, for years beginning after 2016, 62321), 62311 (or, for years beginning after 2016, 62323), 62264, 64490, 64493, or G0260, or any successor code, apply.

added “(iii) This subparagraph shall not be applied in a budget-neutral manner.”

added “(7) Requirement of e-prescribing for controlled substances

added “(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).

added “(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—

added “(i) a prescription issued when the practitioner and dispenser are the same entity;

added “(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;

added “(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;

added “(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;

added “(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;

added “(vi) a prescription issued by a practitioner prescribing a drug under a research protocol;

added “(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

added “(viii) a prescription issued by a practitioner for an individual who—

added “(I) receives hospice care under this title; or

added “(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.

added “(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.

added “(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).”

added Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)) is amended—

added “(F) With respect to plan years beginning on or after January 1, 2021, a drug management program for at-risk beneficiaries described in paragraph (5).”

added “(HH) opioid use disorder treatment services (as defined in subsection (jjj)).”

added “(jjj) Opioid use disorder treatment services; opioid treatment program

added “(1) Opioid use disorder treatment services—The term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including—

added “(A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug and Cosmetic Act for use in the treatment of opioid use disorder;

added “(B) dispensing and administration of such medications, if applicable;

added “(C) substance use counseling by a professional to the extent authorized under State law to furnish such services;

added “(D) individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law);

added “(E) toxicology testing, and

added “(F) other items and services that the Secretary determines are appropriate (but in no event to include meals or transportation).

added “(2) Opioid treatment program—The term opioid treatment program means an entity that is opioid treatment program (as defined in section 8.2 of title 42 of the Code of Federal Regulations, or any successor regulation) that—

added “(A) is enrolled under section 1866(j);

added “(B) has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program;

added “(C) is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and

added “(D) meets such additional conditions as the Secretary may find necessary to ensure—

added “(i) the health and safety of individuals being furnished services under such program; and

added “(ii) the effective and efficient furnishing of such services.”

added “(w) Opioid use disorder treatment services

added “(1) In general—The Secretary shall pay to an opioid treatment program (as defined in paragraph (2) of section 1861(jjj)) an amount that is equal to 100 percent of a bundled payment under this part for opioid use disorder treatment services (as defined in paragraph (1) of such section) that are furnished by such program to an individual during an episode of care (as defined by the Secretary) beginning on or after January 1, 2020. The Secretary shall ensure, as determined appropriate by the Secretary, that no duplicative payments are made under this part or part D for items and services furnished by an opioid treatment program.

added “(2) Considerations—The Secretary may implement this subsection through one or more bundles based on the type of medication provided (such as buprenorphine, methadone, naltrexone, or a new innovative drug), the frequency of services, the scope of services furnished, characteristics of the individuals furnished such services, or other factors as the Secretary determine appropriate. In developing such bundles, the Secretary may consider payment rates paid to opioid treatment programs for comparable services under State plans under title XIX or under the TRICARE program under chapter 55 of title 10 of the United States Code.

added “(3) Annual updates—The Secretary shall provide an update each year to the bundled payment amounts under this subsection.”

added “(3) opioid treatment programs (as defined in paragraph (2) of section 1861(jjj)), but only with respect to the furnishing of opioid use disorder treatment services (as defined in paragraph (1) of such section).”

added “4 Public Health Laboratories

added “355. Public health laboratories to detect fentanyl

added “(a) In general—The Secretary shall establish a program to award grants to Federal, State, and local agencies to support the establishment or operation of public health laboratories to detect fentanyl, its analogues, and other synthetic opioids, as described in subsection (b).

added “(b) Standards—The Secretary, in consultation with the Director of the National Institute of Standards and Technology, shall—

added “(1) develop standards for safely and effectively handling and testing fentanyl, its analogues, and other synthetic opioids;

added “(2) develop fentanyl and fentanyl analog reference materials and quality control standards and protocols to calibrate instrumentation for clinical diagnostics and postmortem surveillance; and

added “(3) include in the standards developed pursuant to paragraph (1) procedures for encountering new and emerging synthetic opioid formulations and reporting those findings to other Federal, State, and local public health laboratories.

added “(c) Laboratories—The Secretary shall require grantees under subsection (a) to—

added “(1) follow the standards established under subsection (b) and be capable of providing systematic and routine laboratory testing of drugs for the purposes of obtaining and disseminating public health information to Federal, State, and local public health officials, laboratories, and other entities the Secretary deems appropriate;

added “(2) work with law enforcement agencies and public health authorities, as feasible, to develop real-time information on the purity and movement of fentanyl, its analogues, and other synthetic opioids;

added “(3) assist State and local law enforcement agencies in testing seized drugs when State and local forensic laboratories request additional assistance;

added “(4) provide early warning information and advice to Federal, State, and local law enforcement agencies and public health authorities regarding potential significant changes in the supply of fentanyl, its analogues, and other synthetic opioids;

added “(5) provide biosurveillance for non-fatal exposures; and

added “(6) provide diagnostic testing for non-fatal exposures of emergency personnel.

added “(d) Authorization of appropriations—To carry out this section, there is authorized to be appropriated $15,000,000 for each of fiscal years 2019 through 2023.”

added “317U. Enhanced fentanyl surveillance

added “(a) In general—The Director of the Centers for Disease Control and Prevention shall enhance its drug surveillance program by—

added “(1) expanding its surveillance program to include all 50 States and the territories of the United States;

added “(2) increasing and accelerating the collection of data on fentanyl, its analogues, and other synthetic opioids and new emerging drugs of abuse, including related overdose data from medical examiners and drug treatment admissions; and

added “(3) utilizing available and emerging information on fentanyl, its analogues, and other synthetic opioids and new emerging drugs of abuse, including information from—

added “(A) the National Drug Early Warning System;

added “(B) State and local public health authorities; and

added “(C) Federal, State, and local public health laboratories.

added “(b) Authorization of appropriations—To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2019 through 2023.”

added “399V–7. Pilot program for point-of-Use testing of illicit drugs for dangerous contaminants

added “(a) In general—The Secretary shall—

added “(1) establish a pilot program through which 5 State or local agencies conduct, in 5 States, point-of-use testing of illicit drugs for dangerous contaminants;

added “(2) establish metrics to evaluate the success of the pilot program in reducing drug overdose rates; and

added “(3) based on such metrics, conduct an annual evaluation of the pilot program and submit an annual report to the Congress containing the results of such evaluation.

added “(b) Authorization of appropriations—To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023.”

added “(II) The applicable number is—

added “(aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients;

added “(bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations); or

added “(cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as such terms are defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)).”

added “(II) a qualifying other practitioner, as defined in clause (iv), who is a nurse practitioner or physician assistant; or”

added “(III) for the period beginning on October 1, 2018, and ending on October 1, 2023, a qualifying other practitioner, as defined in clause (iv), who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife.”

added Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)) is amended by adding at the end the following new paragraph:

added “(7)

added “(A) With respect to expenditures described in subparagraph (B) that are incurred by a State for any fiscal year after fiscal year 2020 (and before fiscal year 2024), in determining the pro rata share to which the United States is equitably entitled under subsection (d)(3), the Secretary shall substitute the Federal medical assistance percentage that applies for such fiscal year to the State under section 1905(b) (without regard to any adjustments to such percentage applicable under such section or any other provision of law) for the percentage that applies to such expenditures under section 1905(y).

added “(B) Expenditures described in this subparagraph, with respect to a fiscal year to which subparagraph (A) applies, are expenditures incurred by a State for payment for medical assistance provided to individuals described in subclause (VIII) of section 1902(a)(10)(A)(i) by a managed care entity, or other specified entity (as defined in subparagraph (D)(iii)), that are treated as remittances because the State—

added “(i) has satisfied the requirement of section 438.8 of title 42, Code of Federal Regulations (or any successor regulation), by electing—

added “(I) in the case of a State described in subparagraph (C), to apply a minimum medical loss ratio (as defined in subparagraph (D)(ii)) that is at least 85 percent but not greater than the minimum medical loss ratio (as so defined) that such State applied as of May 31, 2018; or

added “(II) in the case of a State not described in subparagraph (C), to apply a minimum medical loss ratio that is equal to 85 percent; and

added “(ii) recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio.

added “(C) For purposes of subparagraph (B), a State described in this subparagraph is a State that as of May 31, 2018, applied a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in such subparagraph under the State plan under this title (or a waiver of the plan) that is equal to or greater than 85 percent.

added “(D) For purposes of this paragraph:

added “(i) The term managed care entity means a medicaid managed care organization described in section 1932(a)(1)(B)(i).

added “(ii) The term minimum medical loss ratio means, with respect to a State, a minimum medical loss ratio (as calculated under subsection (d) of section 438.8 of title 42, Code of Federal Regulations (as in effect on June 1, 2018)) for payment for services provided by entities described in subparagraph (B) under the State plan under this title (or a waiver of the plan).

added “(iii) The term other specified entity means—

added “(I) a prepaid inpatient health plan, as defined in section 438.2 of title 42, Code of Federal Regulations (or any successor regulation); and

added “(II) a prepaid ambulatory health plan, as defined in such section (or any successor regulation).”

added Section 1862(b)(1)(C) of the Social Security Act (42 U.S.C. 1395y(b)(1)(C)) is amended—

added Clause (i) of section 1862(b)(7)(A) of the Social Security Act (42 U.S.C. 1395y(b)(7)(A)) is amended to read as follows:

added “(i) secure from the plan sponsor and plan participants such information as the Secretary shall specify for the purpose of identifying situations where the group health plan is or has been—

added “(I) a primary plan to the program under this title; or

added “(II) for calendar quarters beginning on or after January 1, 2020, a primary payer with respect to benefits relating to prescription drug coverage under part D; and”

added Section 1139B of the Social Security Act (42 U.S.C. 1320b–9b) is amended—

added “(A) Voluntary reporting—Not later than January 1, 2013”

added “(B) Mandatory reporting with respect to behavioral health measures—Beginning with the State report required under subsection (d)(1) for 2024, the Secretary shall require States to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information, using the standardized format for reporting information and procedures developed under subparagraph (A), regarding the quality of behavioral health care for Medicaid eligible adults.”

added “(C) Behavioral health measures—Beginning with respect to State reports required under subsection (d)(1) for 2024, the core set of adult health quality measures maintained under this paragraph (and any updates or changes to such measures) shall include behavioral health measures.”

added This subtitle may be cited as the “Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations Act” or the “Medicaid IMD ADDITIONAL INFO Act”.

added This subtitle may be cited as the “CHIP Mental Health Parity Act”.

added “(E) Mental health and substance use disorder services (as defined in paragraph (5)).”

added “(5) Mental health and substance use disorder services—Regardless of the type of coverage elected by a State under subsection (a), child health assistance provided under such coverage for targeted low-income children and, in the case that the State elects to provide pregnancy-related assistance under such coverage pursuant to section 2112, such pregnancy-related assistance for targeted low-income women (as defined in section 2112(d)) shall—

added “(A) include coverage of mental health services (including behavioral health treatment) necessary to prevent, diagnose, and treat a broad range of mental health symptoms and disorders, including substance use disorders; and

added “(B) be delivered in a culturally and linguistically appropriate manner.”

added “(A) In general—A State child health plan shall ensure that the financial requirements and treatment limitations applicable to mental health and substance use disorder services (as described in paragraph (5)) provided under such plan comply with the requirements of section 2726(a) of the Public Health Service Act in the same manner as such requirements or limitations apply to a group health plan under such section.”

added This subtitle may be cited as the “Medicaid Reentry Act”.

added This subtitle may be cited as the “Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act” or the “Medicaid PARTNERSHIP Act”.

added “1944. Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances

added “(a) In general—Beginning October 1, 2021, a State shall, subject to subsection (d), require each covered provider to check, in accordance with such timing, manner, and form as specified by the State, the prescription drug history of a covered individual being treated by the covered provider through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance.

added “(b) Qualified prescription drug monitoring program described—A qualified prescription drug monitoring program described in this subsection is, with respect to a State, a prescription drug monitoring program administered by the State that, at a minimum, satisfies each of the following criteria:

added “(1) The program facilitates access by a covered provider to, at a minimum, the following information with respect to a covered individual, in as close to real-time as possible:

added “(A) Information regarding the prescription drug history of a covered individual with respect to controlled substances.

added “(B) The number and type of controlled substances prescribed to and filled for the covered individual during at least the most recent 12-month period.

added “(C) The name, location, and contact information (or other identifying number selected by the State, such as a national provider identifier issued by the National Plan and Provider Enumeration System of the Centers for Medicare & Medicaid Services) of each covered provider who prescribed a controlled substance to the covered individual during at least the most recent 12-month period.

added “(2) The program facilitates the integration of information described in paragraph (1) into the workflow of a covered provider, which may include the electronic system the covered provider uses to prescribe controlled substances.

added “(c) Application of privacy rules clarification—The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b) in the same manner as the Secretary is required under subparagraph (J) of section 1860D–4(c)(5) to clarify privacy requirements related to the sharing of data described in such subparagraph.

added “(d) Ensuring access—In order to ensure reasonable access to health care, the Secretary shall waive the application of the requirement under subsection (a), with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)).

added “(e) Reports

added “(1) State reports—Each State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D), beginning with such reports submitted for 2023, information including, at a minimum, the following information for the most recent 12-month period:

added “(A) The percentage of covered providers (as determined pursuant to a process established by the State) who checked the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance.

added “(B) Aggregate trends with respect to prescribing controlled substances such as—

added “(i) the quantity of daily morphine milligram equivalents prescribed for controlled substances;

added “(ii) the number and quantity of daily morphine milligram equivalents prescribed for controlled substances per covered individual; and

added “(iii) the types of controlled substances prescribed, including the dates of such prescriptions, the supplies authorized (including the duration of such supplies), and the period of validity of such prescriptions, in different populations (such as individuals who are elderly, individuals with disabilities, and individuals who are enrolled under both this title and title XVIII).

added “(C) Whether or not the State requires (and a detailed explanation as to why the State does or does not require) pharmacists to check the prescription drug history of a covered individual through a qualified drug management program before dispensing a controlled substance to such individual.

added “(2) Report by CMS—Not later than October 1, 2023, the Administrator of the Centers for Medicare & Medicaid Services shall publish on the publicly available website of the Centers for Medicare & Medicaid Services a report including the following information:

added “(A) Guidance for States on how States can increase the percentage of covered providers who use qualified prescription drug monitoring programs described in subsection (b).

added “(B) Best practices for how States and covered providers should use such qualified prescription drug monitoring programs to reduce the occurrence of abuse of controlled substances.

added “(f) Increase to Federal matching rate for certain expenditures relating to qualified prescription drug management programs—The Secretary shall increase the Federal medical assistance percentage or Federal matching rate that would otherwise apply to a State under section 1903(a) for a calendar quarter occurring during the period beginning October 1, 2018, and ending September 30, 2021, for expenditures by the State for activities under the State plan (or waiver of the State plan) to implement a prescription drug management program that satisfies the criteria described in paragraphs (1) and (2) of subsection (b) if the State (in this subsection referred to as the “administering State”) has in place agreements with all States that are contiguous to such administering State that, when combined, enable covered providers in all such contiguous States to access, through the prescription drug management program, the information that is described in subsection (b)(1) of covered individuals of such administering State and that covered providers in such administering State are able to access through such program. In no case shall an increase under this subsection result in a Federal medical assistance percentage or Federal matching rate that exceeds 100 percent.

added “(g) Rule of construction—Nothing in this section prevents a State from requiring pharmacists to check the prescription drug history of covered individuals through a qualified drug management program before dispensing controlled substances to such individuals.

added “(h) Definitions—In this section:

added “(1) Controlled substance—The term controlled substance means a drug that is included in schedule II of section 202(c) of the Controlled Substances Act and, at the option of the State involved, a drug included in schedule III or IV of such section.

added “(2) Covered individual—The term covered individual means, with respect to a State, an individual who is enrolled in the State plan (or under a waiver of such plan). Such term does not include an individual who—

added “(A) is receiving—

added “(i) hospice or palliative care; or

added “(ii) treatment for cancer;

added “(B) is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or

added “(C) the State elects to treat as exempted from such term.

added “(3) Covered provider

added “(A) In general—The term covered provider means, subject to subparagraph (B), with respect to a State, a health care provider who is participating under the State plan (or waiver of the State plan) and licensed, registered, or otherwise permitted by the State to prescribe a controlled substance (or the designee of such provider).

added “(B) Exceptions

added “(i) In general—Beginning October 1, 2021, for purposes of this section, such term does not include a health care provider included in any type of health care provider determined by the Secretary to be exempt from application of this section under clause (ii).

added “(ii) Exceptions process—Not later than October 1, 2020, the Secretary, after consultation with the National Association of Medicaid Directors, national health care provider associations, Medicaid beneficiary advocates, and advocates for individuals with rare diseases, shall determine, based on such consultations, the types of health care providers (if any) that should be exempted from the definition of the term covered provider for purposes of this section.”

added Section 1115A(b)(2)(B) of the Social Security Act (42 U.S.C. 1315a(b)(2)(B)) is amended by adding at the end the following new clause:

added “(xxv) Providing, for the adoption and use of certified EHR technology (as defined in section 1848(o)(4)) to improve the quality and coordination of care through the electronic documentation and exchange of health information, incentive payments to behavioral health providers (such as psychiatric hospitals (as defined in section 1861(f)), community mental health centers (as defined in section 1861(ff)(3)(B)), hospitals that participate in a State plan under title XIX or a waiver of such plan, treatment facilities that participate in such a State plan or such a waiver, mental health or substance use disorder providers that participate in such a State plan or such a waiver, clinical psychologists (as defined in section 1861(ii)), nurse practitioners (as defined in section 1861(aa)(5)) with respect to the provision of psychiatric services, and clinical social workers (as defined in section 1861(hh)(1))).”

added This subtitle may be cited at the “Abuse Deterrent Access Act of 2018”.

added This subtitle may be cited as the “Medicare Opioid Safety Education Act of 2018”.

added “(d) The notice provided under subsection (a) shall include—

added “(1) educational resources, compiled by the Secretary, regarding opioid use and pain management; and

added “(2) a description of alternative, non-opioid pain management treatments covered under this title.”

added This subtitle may be cited as the “Opioid Addiction Action Plan Act”.

added This subtitle may be cited as the “Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act”.

added 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:

added “1866F. Opioid use disorder treatment demonstration program

added “(a) Implementation of 4-year demonstration program

added “(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 services to be furnished, to applicable beneficiaries participating in the Program.

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

added “(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

added “(B) includes—

added “(i) medication assisted treatment;

added “(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

added “(v) care management and care coordination services, including coordination with other providers of services and suppliers not on an opioid use disorder care team.

added “(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:

added “(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).

added “(D) Does not increase the total spending on items and services under this title.

added “(E) Reduces deaths from opioid overdose.

added “(F) Reduces the utilization of inpatient residential treatment.

added “(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.

added “(c) Participants; opioid use disorder care teams

added “(1) Participants

added “(A) Definition—In this section, the term participant means an entity or individual—

added “(i) that is otherwise enrolled under this title and that is—

added “(I) a physician (as defined in section 1861(r)(1));

added “(II) a group practice comprised of at least one physician described in subclause (I);

added “(III) a hospital outpatient department;

added “(IV) a 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.

added “(2) Opioid use disorder care teams

added “(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—

added “(i) shall include—

added “(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

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; and

added “(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—

added “(I) monitor and evaluate the Program;

added “(II) determine if minimum criteria are met under clause (ii); and

added “(III) determine the incentive payment under subsection (e).

added “(3) Eligible practitioners; Other provider-related definitions and application provisions

added “(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—

added “(i) is enrolled under section 1866(j)(1);

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

added “(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.

added “(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.

added “(d) Participation of applicable beneficiaries

added “(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;

added “(B) is not enrolled in a Medicare Advantage plan under part C;

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

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

added “(2) Voluntary beneficiary participation; limitation on number of beneficiaries—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.

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

added “(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 “(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.

added “(2) Incentive payments

added “(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).

added “(B) Criteria

added “(i) In general—Criteria described in subparagraph (A) may include consideration of the following:

added “(I) Patient engagement and retention in treatment.

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

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

added “(ii) Required consultation and consideration—In determining criteria described in subparagraph (A), the Secretary shall—

added “(I) consult with stakeholders, including clinicians in the primary care community and in the field of addiction medicine; and

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

added “(C) No duplicate payment—The Secretary shall ensure that no duplicate payments under this paragraph are made with respect to an applicable beneficiary.

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—

added “(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

added “(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)), $5,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841.

added “(2) Care management fees and incentives—For the purposes of making payments under subsection (e), $10,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 for each of fiscal years 2021 through 2024.

added “(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.”

added This subtitle may be cited as the “Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment Act of 2018” or the “REACH OUT Act of 2018”.

added This subtitle may be cited as the “Preventing Addiction for Susceptible Seniors Act of 2018” or the “PASS Act of 2018” .

added “(E) Electronic prior authorization

added “(i) In general—Not later than January 1, 2021, the program shall provide for the secure electronic transmission of—

added “(I) a prior authorization request from the prescribing health care professional for coverage of a covered part D drug for a part D eligible individual enrolled in a part D plan (as defined in section 1860D–23(a)(5)) to the PDP sponsor or Medicare Advantage organization offering such plan; and

added “(II) a response, in accordance with this subparagraph, from such PDP sponsor or Medicare Advantage organization, respectively, to such professional.

added “(ii) Electronic transmission

added “(I) Exclusions—For purposes of this subparagraph, a facsimile, a proprietary payer portal that does not meet standards specified by the Secretary, or an electronic form shall not be treated as an electronic transmission described in clause (i).

added “(II) Standards—In order to be treated, for purposes of this subparagraph, as an electronic transmission described in clause (i), such transmission shall comply with technical standards adopted by the Secretary in consultation with the National Council for Prescription Drug Programs, other standard setting organizations determined appropriate by the Secretary, and stakeholders including PDP sponsors, Medicare Advantage organizations, health care professionals, and health information technology software vendors.

added “(III) Application—Notwithstanding any other provision of law, for purposes of this subparagraph, the Secretary may require the use of such standards adopted under subclause (II) in lieu of any other applicable standards for an electronic transmission described in clause (i) for a covered part D drug for a part D eligible individual.”

added “(i) Program integrity transparency measures

added “(1) Program integrity portal

added “(A) In general—Not later than 2 years after the date of the enactment of this subsection, the Secretary shall, after consultation with stakeholders, establish a secure Internet website portal (or other successor technology) that would allow a secure path for communication between the Secretary, MA plans under this part, prescription drug plans under part D, and an eligible entity with a contract under section 1893 (such as a Medicare drug integrity contractor or an entity responsible for carrying out program integrity activities under this part and part D) for the purpose of enabling through such portal (or other successor technology)—

added “(i) the referral by such plans of substantiated fraud, waste, and abuse for initiating or assisting investigations conducted by the eligible entity; and

added “(ii) data sharing among such MA plans, prescription drug plans, and the Secretary.

added “(B) Required uses of portal—The Secretary shall disseminate the following information to MA plans under this part and prescription drug plans under part D through the secure Internet website portal (or other successor technology) established under subparagraph (A):

added “(i) Providers of services and suppliers that have been referred pursuant to subparagraph (A)(i) during the previous 12-month period.

added “(ii) Providers of services and suppliers who are the subject of an active exclusion under section 1128 or who are subject to a suspension of payment under this title pursuant to section 1862(o) or otherwise.

added “(iii) Providers of services and suppliers who are the subject of an active revocation of participation under this title, including for not satisfying conditions of participation.

added “(iv) In the case of such a plan that makes a referral under subparagraph (A)(i) through the portal (or other successor technology) with respect to activities of substantiated fraud, waste, or abuse of a provider of services or supplier, if such provider or supplier has been the subject of an administrative action under this title or title XI with respect to similar activities, a notification to such plan of such action so taken.

added “(C) Rulemaking—For purposes of this paragraph, the Secretary shall, through rulemaking, specify what constitutes substantiated fraud, waste, and abuse, using guidance such as what is provided in the Medicare Program Integrity Manual 4.7.1. In carrying out this subsection, a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for substantiated fraud, waste, or abuse.

added “(D) HIPAA compliant information only—For purposes of this subsection, communications may only occur if the communications are permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996.

added “(2) Quarterly reports—Beginning 2 years after the date of enactment of this subsection, the Secretary shall make available to MA plans under this part and prescription drug plans under part D in a timely manner (but no less frequently than quarterly) and using information submitted to an entity described in paragraph (1) through the portal (or other successor technology) described in such paragraph or pursuant to section 1893, information on fraud, waste, and abuse schemes and trends in identifying suspicious activity. Information included in each such report shall—

added “(A) include administrative actions, pertinent information related to opioid overprescribing, and other data determined appropriate by the Secretary in consultation with stakeholders; and

added “(B) be anonymized information submitted by plans without identifying the source of such information.

added “(3) Clarification—Nothing in this subsection shall be construed as precluding or otherwise affecting referrals described in subparagraph (A) that may otherwise be made to law enforcement entities or to the Secretary.”

added “(5) Communicating plan corrective actions against opioids over-prescribers

added “(A) In general—Beginning with plan years beginning on or after January 1, 2021, a contract under this section with an MA organization shall require the organization to submit to the Secretary, through the process established under subparagraph (B), information on the investigations and other actions taken by such plans related to providers of services who prescribe a high volume of opioids.

added “(B) Process—Not later than January 1, 2021, the Secretary shall, in consultation with stakeholders, establish a process under which MA plans and prescription drug plans shall submit to the Secretary information described in subparagraph (A).

added “(C) Regulations—For purposes of this paragraph, including as applied under section 1860D–12(b)(3)(D), the Secretary shall, pursuant to rulemaking—

added “(i) specify a definition for the term high volume of opioids and a method for determining if a provider of services prescribes such a high volume; and

added “(ii) establish the process described in subparagraph (B) and the types of information that shall be submitted through such process.”

added “(m) Program integrity transparency measures—For program integrity transparency measures applied with respect to prescription drug plan and MA plans, see section 1859(i).”

added Section 1860D–4(c)(2)(A)(ii) of the Social Security Act (42 U.S.C. 1395w–104(c)(2)(A)(ii)) is amended—

added “(I) Part D eligible individuals who—”

added “(II) Beginning January 1, 2021, at-risk beneficiaries for prescription drug abuse (as defined in paragraph (5)(C)).”

added Section 1860D–4(c)(4) of the Social Security Act (42 U.S.C. 1395w–104(c)(4)) is amended by adding at the end the following new subparagraph:

added “(D) Outlier prescriber notification

added “(i) Notification—Beginning not later than 2 years after the date of the enactment of this subparagraph, the Secretary shall, in the case of a prescriber identified by the Secretary under clause (ii) to be an outlier prescriber of opioids, provide, subject to clause (iv), an annual notification to such prescriber that such prescriber has been so identified and that includes resources on proper prescribing methods and other information specified in accordance with clause (iii).

added “(ii) Identification of outlier prescribers of opioids

added “(I) In general—The Secretary shall, subject to subclause (III), using the valid prescriber National Provider Identifiers included pursuant to subparagraph (A) on claims for covered part D drugs for part D eligible individuals enrolled in prescription drug plans under this part or MA–PD plans under part C and based on the threshold established under subclause (II), conduct an analysis to identify prescribers that are outlier opioid prescribers for a period specified by the Secretary.

added “(II) Establishment of threshold—For purposes of subclause (I) and subject to subclause (III), the Secretary shall, after consultation with stakeholders, establish a threshold, based on prescriber specialty and geographic area, for identifying whether a prescriber in a specialty and geographic area is an outlier prescriber of opioids as compared to other prescribers of opioids within such specialty and area.

added “(III) Exclusions—The Secretary may exclude the following individuals and prescribers from the analysis under this clause:

added “(aa) Individuals receiving hospice services.

added “(bb) Individuals with a cancer diagnosis.

added “(cc) Prescribers who are the subject of an investigation by the Centers for Medicare & Medicaid Services or the Office of Inspector General of the Department of Health and Human Services.

added “(iii) Contents of notification—The Secretary shall, based on input from stakeholders, specify the resources and other information to be included in notifications provided under clause (i).

added “(iv) Modifications and expansions

added “(I) Frequency—Beginning 5 years after the date of the enactment of this subparagraph, the Secretary may change the frequency of the notifications described in clause (i) based on stakeholder input.

added “(II) Expansion to other prescriptions—The Secretary may expand notifications under this subparagraph to include identifications and notifications with respect to concurrent prescriptions of covered Part D drugs used in combination with opioids that are considered to have adverse side effects when so used in such combination, as determined by the Secretary.

added “(v) Opioids defined—For purposes of this subparagraph, the term opioids has such meaning as specified by the Secretary through program instruction or otherwise.”

added No additional funds are authorized to be appropriated to carry out the requirements of this subtitle and the amendments made by this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated.

added This subtitle may be cited as the “Expanding Oversight of Opioid Prescribing and Payment Act of 2018”.

added Not later than March 15, 2019, the Medicare Payment Advisory Commission shall submit to Congress a report on, with respect to the Medicare program under title XVIII of the Social Security Act, the following:

added No additional funds are authorized to be appropriated to carry out the requirements of this subtitle. Such requirements shall be carried out using amounts otherwise authorized to be appropriated.

added This subtitle may be cited as the “Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018”.

added “(22) Review and revisions of payments for non-opioid alternative treatments

added “(A) In general—With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary—

added “(i) shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives;

added “(ii) may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and

added “(iii) shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management.

added “(B) Priority—In conducting the review under clause (i) of subparagraph (A) and considering revisions under clause (iii) of such subparagraph, the Secretary shall focus on covered OPD services (or groups of services) assigned to a comprehensive ambulatory payment classification, ambulatory payment classifications that primarily include surgical services, and other services determined by the Secretary which generally involve treatment for pain management.

added “(C) Revisions—If the Secretary identifies revisions to payments pursuant to subparagraph (A)(iii), the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after January 1, 2020. Revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph (9)(B).

added “(D) Rules of construction—Nothing in this paragraph shall be construed to preclude the Secretary—

added “(i) from conducting a demonstration before making the revisions described in subparagraph (C); or

added “(ii) prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management.”

added “(8) The Secretary shall conduct a similar type of review as required under paragraph (22) of section 1833(t)), including the second sentence of subparagraph (C) of such paragraph, to payment for services under this subsection, and make such revisions under this paragraph, in an appropriate manner (as determined by the Secretary).”

added “(3) Additional payments for certain FQHCs with physicians or other practitioners receiving DATA 2000 waivers

added “(A) In general—In the case of a Federally qualified health center with respect to which, beginning on or after January 1, 2019, Federally-qualified health center services (as defined in section 1861(aa)(3)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in subparagraph (C) the Secretary shall, subject to availability of funds under subparagraph (D), make a payment (at such time and in such manner as specified by the Secretary) to such Federally qualified health center after receiving and approving an application submitted by such Federally qualified health center under subparagraph (B). Such a payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in subparagraph (C)(ii). Such a payment may be made only one time with respect to each such physician or practitioner.

added “(B) Application—In order to receive a payment described in subparagraph (A), a Federally-qualified health center shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A Federally-qualified health center may apply for such a payment for each physician or practitioner described in subparagraph (A) furnishing services described in such subparagraph at such center.

added “(C) Requirements—For purposes of subparagraph (A), the requirements described in this subparagraph, with respect to a physician or practitioner, are the following:

added “(i) The physician or practitioner is employed by or working under contract with a Federally qualified health center described in subparagraph (A) that submits an application under subparagraph (B).

added “(ii) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Acton or after January 1, 2019.

added “(D) Funding—For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6,000,000, which shall remain available until expended.”

added “(bb) Additional payments for certain rural health clinics with physicians or practitioners receiving DATA 2000 waivers

added “(1) In general—In the case of a rural health clinic with respect to which, beginning on or after January 1, 2019, rural health clinic services (as defined in section 1861(aa)(1)) are furnished for the treatment of opioid use disorder by a physician or practitioner who meets the requirements described in paragraph (3), the Secretary shall, subject to availability of funds under paragraph (4), make a payment (at such time and in such manner as specified by the Secretary) to such rural health clinic after receiving and approving an application described in paragraph (2). Such payment shall be in an amount determined by the Secretary, based on an estimate of the average costs of training for purposes of receiving a waiver described in paragraph (3)(B). Such payment may be made only one time with respect to each such physician or practitioner.

added “(2) Application—In order to receive a payment described in paragraph (1), a rural health clinic shall submit to the Secretary an application for such a payment at such time, in such manner, and containing such information as specified by the Secretary. A rural health clinic may apply for such a payment for each physician or practitioner described in paragraph (1) furnishing services described in such paragraph at such clinic.

added “(3) Requirements—For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following:

added “(A) The physician or practitioner is employed by or working under contract with a rural health clinic described in paragraph (1) that submits an application under paragraph (2).

added “(B) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Acton or after January 1, 2019.

added “(4) Funding—For purposes of making payments under this subsection, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $2,000,000, which shall remain available until expended.”

added “(xxv) Supporting ways to familiarize individuals with the availability of coverage under part B of title XVIII for qualified psychologist services (as defined in section 1861(ii)).

added “(xxvi) Exploring ways to avoid unnecessary hospitalizations or emergency department visits for mental and behavioral health services (such as for treating depression) through use of a 24-hour, 7-day a week help line that may inform individuals about the availability of treatment options, including the availability of qualified psychologist services (as defined in section 1861(ii)).”

added This subtitle may be cited as the “Combating Opioid Abuse for Care in Hospitals Act of 2018” or the “COACH Act of 2018”.

added “(g) Technical expert panel review of opioid and opioid use disorder quality measures

added “(1) In general—Not later than 180 days after the date of the enactment of this subsection, the Secretary shall establish a technical expert panel for purposes of reviewing quality measures relating to opioids and opioid use disorders, including care, prevention, diagnosis, health outcomes, and treatment furnished to individuals with opioid use disorders. The Secretary may use the entity with a contract under section 1890(a) and amend such contract as necessary to provide for the establishment of such technical expert panel.

added “(2) Review and assessment—Not later than 1 year after the date the technical expert panel described in paragraph (1) is established (and periodically thereafter as the Secretary determines appropriate), the technical expert panel shall—

added “(A) review quality measures that relate to opioids and opioid use disorders, including existing measures and those under development;

added “(B) identify gaps in areas of quality measurement that relate to opioids and opioid use disorders, and identify measure development priorities for such measure gaps; and

added “(C) make recommendations to the Secretary on quality measures with respect to opioids and opioid use disorders for purposes of improving care, prevention, diagnosis, health outcomes, and treatment, including recommendations for revisions of such measures, need for development of new measures, and recommendations for including such measures in the Merit-Based Incentive Payment System under section 1848(q), the alternative payment models under section 1833(z)(3)(C), the shared savings program under section 1899, the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii), and the hospital value-based purchasing program under section 1886(o).

added “(3) Consideration of measures by secretary—The Secretary shall consider—

added “(A) using opioid and opioid use disorder measures (including measures used under the Merit-Based Incentive Payment System under section 1848(q), measures recommended under paragraph (2)(C), and other such measures identified by the Secretary) in alternative payment models under section 1833(z)(3)(C) and in the shared savings program under section 1899; and

added “(B) using opioid measures described in subparagraph (A), as applicable, in the quality reporting requirements for inpatient hospitals under section 1886(b)(3)(B)(viii),and in the hospital value-based purchasing program under section 1886(o).

added “(4) Prioritization of measure development—The Secretary shall prioritize for measure development the gaps in quality measures identified under paragraph (2)(B).”

added This subtitle may be cited as the “Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018” or the “SENIOR Communities Protection Act of 2018”.

added “(7) Suspension of payments pending investigation of credible allegations of fraud by pharmacies

added “(A) In general—The provisions of section 1862(o) shall apply with respect to a PDP sponsor with a contract under this part, a pharmacy, and payments to such pharmacy under this part in the same manner as such provisions apply with respect to the Secretary, a provider of services or supplier, and payments to such provider of services or supplier under this title.

added “(B) Rule of construction—Nothing in this paragraph shall be construed as limiting the authority of a PDP sponsor to conduct postpayment review.”

added “(D) Suspension of payments pending investigation of credible allegations of fraud by pharmacies—Section 1860D–12(b)(7).”

added “(4) Credible allegation of fraud—In carrying out this subsection, section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud hotline tip (as defined by the Secretary) without further evidence shall not be treated as sufficient evidence for a credible allegation of fraud.”

added This subtitle may be cited as the “Providing Reliable Options for Patients and Educational Resources Act of 2018” or the “PROPER Act of 2018”.

added Section 1860D–4(a)(1) of the Social Security Act (42 U.S.C. 1395w–104(a)(1)) is amended—

added “(vi) For plan year 2021 and each subsequent plan year, subject to subparagraph (C), with respect to the treatment of pain—

added “(I) the risks associated with prolonged opioid use; and

added “(II) coverage of nonpharmacological therapies, devices, and nonopioid medications—

added “(aa) in the case of an MA-PD plan under part C, under such plan; and

added “(bb) in the case of a prescription drug plan, under such plan and under parts A and B.”

added “(C) Targeted provision of information—A PDP sponsor of a prescription drug plan may, in lieu of disclosing the information described in subparagraph (B)(vi) to each enrollee under the plan, disclose such information through mail or electronic communications to a subset of enrollees under the plan, such as enrollees who have been prescribed an opioid in the previous 2-year period.”

added “(n) Provision of information relating to the safe disposal of certain prescription drugs

added “(1) In general—In the case of an individual enrolled under an MA or MA-PD plan who is furnished an in-home health risk assessment on or after January 1, 2021, such plan shall ensure that such assessment includes information on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under paragraph (2). Such information shall include information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal.

added “(2) Criteria—The Secretary shall, through rulemaking, establish criteria the Secretary determines appropriate with respect to information provided to an individual to ensure that such information sufficiently educates such individual on the safe disposal of prescription drugs that are controlled substances.”

added “(i) may include elements that promote—”

added “(ii) with respect to plan years beginning on or after January 1, 2021, shall provide for—

added “(I) the provision of information to the enrollee on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under section 1852(n)(2), including information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal; and

added “(II) cost-effective means by which an enrollee may so safely dispose of such drugs.”

added “(XII)

added “(aa) With respect to a Hospital Consumer Assessment of Healthcare Providers and Systems survey (or a successor survey) conducted on or after January 1, 2019, such survey may not include questions about communication by hospital staff with an individual about such individual’s pain unless such questions take into account, as applicable, whether an individual experiencing pain was informed about risks associated with the use of opioids and about non-opioid alternatives for the treatment of pain.

added “(bb) The Secretary shall not include on the Hospital Compare Internet website any measures based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 about communication by hospital staff with an individual about such individual’s pain.”

added “(iii) HCAHPS pain questions—The Secretary may not include under subparagraph (A) a measure that is based on the questions appearing on the Hospital Consumer Assessment of Healthcare Providers and Systems survey in 2018 about communication by hospital staff with an individual about the individual’s pain.”

added This subtitle may be cited as the “Synthetic Drug Awareness Act of 2018”.

added This subtitle may be cited as the “Empowering Pharmacists in the Fight Against Opioid Abuse Act”.

added This subtitle may be cited as the “Indexing Narcotics, Fentanyl, and Opioids Act of 2018” or the “INFO Act”.

added Title XVII of the Public Health Service Act (42 U.S.C. 300u et seq.) is amended by adding at the end the following new section:

added “1711. Establishment of substance use disorder information dashboard

added “(a) In general—Not later than 6 months after the date of the enactment of this section, the Secretary of Health and Human Services shall, in consultation with the Director of National Drug Control Policy, establish and periodically update a public information dashboard that—

added “(1) coordinates information on programs within the Department of Health and Human Services related to the reduction of opioid abuse and other substance use disorders;

added “(2) provides access to publicly available data from other Federal agencies; State, local, and Tribal governments; nonprofit organizations; law enforcement; medical experts; public health educators; and research institutions regarding prevention, treatment, recovery, and other services for opioid use disorder and other substance use disorders;

added “(3) provides comparable data on substance use disorder prevention and treatment strategies in different regions and population of the United States;

added “(4) provides recommendations for health care providers on alternatives to controlled substances for pain management, including approaches studied by the National Institutes of Health Pain Consortium and the National Center for Complimentary and Integrative Health; and

added “(5) provides guidelines and best practices for health care providers regarding treatment of substance use disorders.

added “(b) Controlled substance defined—In this section, the term “controlled substance” has the meaning given that term in section 102 of the Controlled Substances Act (21 U.S.C. 802).”

added This subtitle may be cited as the “Ensuring Access to Quality Sober Living Act of 2018”.

added Part P of title III of the Public Health Service Act is amended by adding at the end the following new section:

added “399V–7. National recovery housing best practices

added “(a) Best practices—The Secretary of Health and Human Services, in consultation with the Secretary for Housing and Urban Development, patients with a history of opioid use disorder, and other stakeholders, which may include State accrediting entities and reputable providers, analysts, and stakeholders of recovery housing services, such as the National Alliance for Recovery Residences, shall identify or facilitate the development of best practices, which may include model laws for implementing suggested minimum standards, for operating recovery housing.

added “(b) Dissemination—The Secretary shall disseminate the best practices identified or developed under subsection (a) to—

added “(1) State agencies, which may include the provision of technical assistance to State agencies seeking to adopt or implement such best practices;

added “(2) recovery housing entities; and

added “(3) the public, as appropriate.

added “(c) Definitions—In this section:

added “(1) The term recovery housing means a shared living environment free from alcohol and illicit drug use and centered on peer support and connection to services, including medication-assisted treatment services, that promote sustained recovery from substance use disorders.

added “(2) The term “State” includes any of the several States, the District of Columbia, each Indian tribe or tribal organization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), and any territory or possession of the United States.

added “(d) Authorization of appropriations—To carry out this section, there is authorized to be appropriated $3,000,000 for the period of fiscal years 2019 through 2021.”

added This subtitle may be cited as the “Advancing Cutting Edge Research Act” or the “ACE Research Act”.

added Section 402(n)(1) of the Public Health Service Act (42 U.S.C. 282(n)(1)) is amended—

added “(C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat.”

added This subtitle may be cited as “Jessie’s Law”.

added This subtitle may be cited as the “Safe Disposal of Unused Medication Act”.

added Subsection (g) of section 302 of the Controlled Substances Act (21 U.S.C. 822) is amended by adding at the end the following:

added “(5)

added “(A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance after the death of such person, so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law.

added “(B) For the purposes of this paragraph:

added “(i) The terms hospice care and hospice program have the meanings given to those terms in section 1861(dd) of the Social Security Act.

added “(ii) The term “employee of a qualified hospice program” means a physician, nurse, or other person who—

added “(I) is employed by, or pursuant to arrangements made by, a qualified hospice program;

added “(II)

added “(aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and

added “(bb) is acting within the scope of such employment in accordance with applicable State law; and

added “(III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion.

added “(iii) The term qualified hospice program means a hospice program that—

added “(I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person’s death;

added “(II) at the time when the controlled substances are first ordered—

added “(aa) provides a copy of the written policies and procedures to the patient or patient representative and family;

added “(bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of controlled substances; and

added “(cc) documents in the patient’s clinical record that the written policies and procedures were provided and discussed; and

added “(III) at the time following the disposal of the controlled substances—

added “(aa) documents in the patient’s clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and

added “(bb) the time, date, and manner in which that disposal occurred.”

added This subtitle may be cited as the “Substance Use Disorder Workforce Loan Repayment Act of 2018”.

added Title VII of the Public Health Service Act is amended—

added “F Substance use disorder treatment employees

added “781. Loan repayment program for substance use disorder treatment employees

added “(a) In general—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall carry out a program under which—

added “(1) the Secretary enters into agreements with individuals to make payments in accordance with subsection (b) on the principal of and interest on any eligible loan; and

added “(2) the individuals each agree to complete a period of service in a substance use disorder treatment job, as described in subsection (d).

added “(b) Payments—For each year of obligated service by an individual pursuant to an agreement under subsection (a), the Secretary shall make a payment to such individual as follows:

added “(1) Service in a shortage area—The Secretary shall pay—

added “(A) for each year of obligated service by an individual pursuant to an agreement under subsection (a), 1/6 of the principal of and interest on each eligible loan of the individual which is outstanding on the date the individual began service pursuant to the agreement; and

added “(B) for completion of the sixth and final year of such service, the remainder of such principal and interest.

added “(2) Maximum amount—The total amount of payments under this section to any individual shall not exceed $250,000.

added “(c) Eligible loans—The loans eligible for repayment under this section are each of the following:

added “(1) Any loan for education or training for a substance use disorder treatment job.

added “(2) Any loan under part E of title VIII (relating to nursing student loans).

added “(3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, or Federal Direct Unsubsidized Stafford Loan, or Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965).

added “(4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965.

added “(5) Any other Federal loan as determined appropriate by the Secretary.

added “(d) Period of service—The period of service required by an agreement under subsection (a) shall consist of up to 6 years of full-time employment, with no more than 1 year passing between any 2 years of covered employment, in a substance use disorder treatment job in the United States in—

added “(1) a Mental Health Professional Shortage Area, as designated under section 332; or

added “(2) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per 100,000 people over the past 3 years for which official data is available from the State, is higher than the most recent available national average overdose death rate per 100,000 people, as reported by the Centers for Disease Control and Prevention.

added “(e) Ineligibility for double benefits—No borrower may, for the same service, receive a reduction of loan obligations or a loan repayment under both—

added “(1) this subsection; and

added “(2) any Federally supported loan forgiveness program, including under section 338B, 338I, or 846 of this Act, or section 428J, 428L, 455(m), or 460 of the Higher Education Act of 1965.

added “(f) Breach

added “(1) Liquidated damages formula—The Secretary may establish a liquidated damages formula to be used in the event of a breach of an agreement entered into under subsection (a).

added “(2) Limitation—The failure by an individual to complete the full period of service obligated pursuant to such an agreement, taken alone, shall not constitute a breach of the agreement, so long as the individual completed in good faith the years of service for which payments were made to the individual under this section.

added “(g) Additional criteria—The Secretary—

added “(1) may establish such criteria and rules to carry out this section as the Secretary determines are needed and in addition to the criteria and rules specified in this section; and

added “(2) shall give notice to the committees specified in subsection (h) of any criteria and rules so established.

added “(h) Report to Congress—Not later than 5 years after the date of enactment of the Substance Use Disorder Workforce Loan Repayment Act of 2018, and every other year thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on—

added “(1) the number and location of borrowers who have qualified for loan repayments under this section; and

added “(2) the impact of this section on the availability of substance use disorder treatment employees nationally and in shortage areas and counties described in subsection (d).

added “(i) Definition—In this section:

added “(1) The term municipality means a city, town, or other public body created by or pursuant to State law, or an Indian Tribe.

added “(2) The term substance use disorder treatment job means a full-time job (including a fellowship)—

added “(A) where the primary intent and function of the job is the direct treatment or recovery support of patients with or in recovery from a substance use disorder, such as a physician, physician assistant, registered nurse, nurse practitioner, advanced practice registered nurse, social worker, recovery coach, mental health counselor, addictions counselor, psychologist or other behavioral health professional, or any other relevant professional as determine by the Secretary; and

added “(B) which is located at a substance use disorder treatment program, private physician practice, hospital or health system-affiliated inpatient treatment center or outpatient clinic (including an academic medical center-affiliated treatment program), correctional facility or program, youth detention center or program, inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or other specialty community behavioral health center, recovery center, school, community-based organization, telehealth platform, migrant health center, health program or facility operated by a tribe or tribal organization, Federal medical facility, or any other facility as determined appropriate for purposes of this section by the Secretary.

added “(j) Authorization of appropriations—There are authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 2019 through 2028.”

added This subtitle may be cited as the “Preventing Overdoses While in Emergency Rooms Act of 2018”.

added This subtitle may be cited as the “Alternatives to Opioids in the Emergency Department Act” or the “ALTO Act”.

added This subtitle may be cited as the “Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act” or the “SCREEN Act”.