IIB 115th CONGRESS 2d Session H. R. 6110 IN THE SENATE OF THE UNITED STATES June 20, 2018 Received; read twice and referred to the Committee on Finance AN ACT To amend title XVIII of the Social Security Act to provide for the review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments, and for other purposes.

1. Short title This Act may be cited as the Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 . 2. Review and adjustment of payments under the Medicare outpatient prospective payment system to avoid financial incentives to use opioids instead of non-opioid alternative treatments (a) Outpatient prospective payment system Section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t) ) is amended by adding at the end the following new paragraph: (22) Review and revisions of payments for non-opioid alternative treatments (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— (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; (ii) may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and (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. (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. (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). (D) Rules of construction Nothing in this paragraph shall be construed to preclude the Secretary— (i) from conducting a demonstration before making the revisions described in subparagraph (C); or (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. . (b) Ambulatory surgical centers Section 1833(i) of the Social Security Act ( 42 U.S.C. 1395l(i) ) is amended by adding at the end the following new paragraph: (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). . 3. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics (a) Federally qualified health centers Section 1834(o) of the Social Security Act ( 42 U.S.C. 1395m(o) ) is amended by adding at the end the following new paragraph: (3) Additional payments for certain FQHCs with physicians or other practitioners receiving DATA 2000 waivers (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. (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. (C) Requirements For purposes of subparagraph (A), the requirements described in this subparagraph, with respect to a physician or practitioner, are the following: (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). (ii) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019. (D) Funding For purposes of making payments under this paragraph, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $6 million, which shall remain available until expended. . (b) Rural health clinic Section 1833 of the Social Security Act ( 42 U.S.C. 1395l ) is amended— (1) by redesignating the subsection (z) relating to medical review of spinal subluxation services as subsection (aa); and (2) by adding at the end the following new subsection: (bb) Additional payments for certain rural health clinics with physicians or practitioners receiving DATA 2000 waivers (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. (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. (3) Requirements For purposes of paragraph (1), the requirements described in this paragraph, with respect to a physician or practitioner, are the following: (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). (B) The physician or practitioner first receives a waiver under section 303(g) of the Controlled Substances Act on or after January 1, 2019. (4) Funding For purposes of making payments under this subsection, there are appropriated, out of amounts in the Treasury not otherwise appropriated, $2 million, which shall remain available until expended. . 4. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans (a) In general Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall submit to Congress a report on the availability of supplemental health care benefits (as described in section 1852(a)(3)(A) of the Social Security Act ( 42 U.S.C. 1395w–22(a)(3)(A) )) designed to treat or prevent substance use disorders under Medicare Advantage plans offered under part C of title XVIII of such Act. Such report shall include the analysis described in subsection (c) and any differences in the availability of such benefits under specialized MA plans for special needs individuals (as defined in section 1859(b)(6) of such Act ( 42 U.S.C. 1395w–28(b)(6) )) offered to individuals entitled to medical assistance under title XIX of such Act and other such Medicare Advantage plans. (b) Consultation The Secretary shall develop the report described in subsection (a) in consultation with relevant stakeholders, including— (1) individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act; (2) entities who advocate on behalf of such individuals; (3) Medicare Advantage organizations; (4) pharmacy benefit managers; and (5) providers of services and suppliers (as such terms are defined in section 1861 of such Act ( 42 U.S.C. 1395x )). (c) Contents The report described in subsection (a) shall include an analysis on the following: (1) The extent to which plans described in such subsection offer supplemental health care benefits relating to coverage of— (A) medication-assisted treatments for opioid use, substance use disorder counseling, peer recovery support services, or other forms of substance use disorder treatments (whether furnished in an inpatient or outpatient setting); and (B) non-opioid alternatives for the treatment of pain. (2) Challenges associated with such plans offering supplemental health care benefits relating to coverage of items and services described in subparagraph (A) or (B) of paragraph (1). (3) The impact, if any, of increasing the applicable rebate percentage determined under section 1854(b)(1)(C) of the Social Security Act ( 42 U.S.C. 1395w–24(b)(1)(C) ) for plans offering such benefits relating to such coverage would have on the availability of such benefits relating to such coverage offered under Medicare Advantage plans. (4) Potential ways to improve upon such coverage or to incentivize such plans to offer additional supplemental health care benefits relating to such coverage. 5. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report (a) CMI models 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 clauses: (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)). (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)). . (b) GAO study and report Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a study, and submit to Congress a report, on mental and behavioral health services under the Medicare program under title XVIII of the Social Security Act, including an examination of the following: (1) Information about services furnished by psychiatrists, clinical psychologists, and other professionals. (2) Information about ways that Medicare beneficiaries familiarize themselves about the availability of Medicare payment for qualified psychologist services (as defined in section 1861(ii) of the Social Security Act ( 42 U.S.C. 1395x(ii) ) and ways that the provision of such information could be improved. 6. Pain management study (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall conduct a study analyzing best practices as well as payment and coverage for pain management services under title XVIII of the Social Security Act and submit to the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report containing options for revising payment to providers and suppliers of services and coverage related to the use of multi-disciplinary, evidence-based, non-opioid treatments for acute and chronic pain management for individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act. The Secretary shall make such report available on the public website of the Centers for Medicare & Medicaid Services. (b) Consultation In developing the report described in subsection (a), the Secretary shall consult with— (1) relevant agencies within the Department of Health and Human Services; (2) licensed and practicing osteopathic and allopathic physicians, behavioral health practitioners, physician assistants, nurse practitioners, dentists, pharmacists, and other providers of health services; (3) providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act ( 42 U.S.C. 1395x )); (4) substance abuse and mental health professional organizations; (5) pain management professional organizations and advocacy entities, including individuals who personally suffer chronic pain; (6) medical professional organizations and medical specialty organizations; (7) licensed health care providers who furnish alternative pain management services; (8) organizations with expertise in the development of innovative medical technologies for pain management; (9) beneficiary advocacy organizations; and (10) other organizations with expertise in the assessment, diagnosis, treatment, and management of pain, as determined appropriate by the Secretary. (c) Contents The report described in subsection (a) shall include the following: (1) An analysis of payment and coverage under title XVIII of the Social Security Act with respect to the following: (A) Evidence-based treatments and technologies for chronic or acute pain, including such treatments that are covered, not covered, or have limited coverage under such title. (B) Evidence-based treatments and technologies that monitor substance use withdrawal and prevent overdoses of opioids. (C) Evidence-based treatments and technologies that treat substance use disorders. (D) Items and services furnished by practitioners through a multi-disciplinary treatment model for pain management, including the patient-centered medical home. (E) Medical devices, non-opioid based drugs, and other therapies (including interventional and integrative pain therapies) approved or cleared by the Food and Drug Administration for the treatment of pain. (F) Items and services furnished to beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, or have comorbidities and require consultation or management of pain with one or more specialists in pain management, mental health, or addiction treatment. (2) An evaluation of the following: (A) Barriers inhibiting individuals entitled to benefits under part A or enrolled under part B of such title from accessing treatments and technologies described in subparagraphs (A) through (F) of paragraph (1). (B) Costs and benefits associated with potential expansion of coverage under such title to include items and services not covered under such title that may be used for the treatment of pain, such as acupuncture, therapeutic massage, and items and services furnished by integrated pain management programs. (C) Pain management guidance published by the Federal Government that may be relevant to coverage determinations or other coverage requirements under title XVIII of the Social Security Act. (3) An assessment of all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids. Such assessment shall consider incorporating into such guidance relevant elements of the VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain published in February 2017 by the Department of Veterans Affairs and Department of Defense, including adoption of elements of the Department of Defense and Veterans Administration pain rating scale. (4) The options described in subsection (d). (5) The impact analysis described in subsection (e). (d) Options The options described in this subsection are, with respect to individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act, legislative and administrative options for accomplishing the following: (1) Improving coverage of and payment for pain management therapies without the use of opioids, including interventional pain therapies, and options to augment opioid therapy with other clinical and complementary, integrative health services to minimize the risk of substance use disorder, including in a hospital setting. (2) Improving coverage of and payment for medical devices and non-opioid based pharmacological and non-pharmacological therapies approved or cleared by the Food and Drug Administration for the treatment of pain as an alternative or augment to opioid therapy. (3) Improving and disseminating treatment strategies for beneficiaries with psychiatric disorders, substance use disorders, or who are at risk of suicide, and treatment strategies to address health disparities related to opioid use and opioid abuse treatment. (4) Improving and disseminating treatment strategies for beneficiaries with comorbidities who require a consultation or comanagement of pain with one or more specialists in pain management, mental health, or addiction treatment, including in a hospital setting. (5) Educating providers on risks of coadministration of opioids and other drugs, particularly benzodiazepines. (6) Ensuring appropriate case management for beneficiaries who transition between inpatient and outpatient hospital settings, or between opioid therapy to non-opioid therapy, which may include the use of care transition plans. (7) Expanding outreach activities designed to educate providers of services and suppliers under the Medicare program and individuals entitled to benefits under part A or under part B of such title on alternative, non-opioid therapies to manage and treat acute and chronic pain. (8) Creating a beneficiary education tool on alternatives to opioids for chronic pain management. (e) Impact analysis The impact analysis described in this subsection consists of an analysis of any potential effects implementing the options described in subsection (d) would have— (1) on expenditures under the Medicare program; and (2) on preventing or reducing opioid addiction for individuals receiving benefits under the Medicare program. 7. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies (a) In general Section 1860D–12(b) of the Social Security Act ( 42 U.S.C. 1395w–112(b) ) is amended by adding at the end the following new paragraph: (7) Suspension of payments pending investigation of credible allegations of fraud by pharmacies (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. (B) Rule of construction Nothing in this paragraph shall be construed as limiting the authority of a PDP sponsor to conduct postpayment review. . (b) Application to MA–PD plans Section 1857(f)(3) of the Social Security Act ( 42 U.S.C. 1395w–27(f)(3) ) is amended by adding at the end the following new subparagraph: (D) Suspension of payments pending investigation of credible allegations of fraud by pharmacies Section 1860D–12(b)(7). . (c) Conforming amendment Section 1862(o)(3) of the Social Security Act ( 42 U.S.C. 1395y(o)(3) ) is amended by inserting , section 1860D–12(b)(7) (including as applied pursuant to section 1857(f)(3)(D)), after this subsection . (d) Clarification relating to credible allegation of fraud Section 1862(o) of the Social Security Act ( 42 U.S.C. 1395y(o) ) is amended by adding at the end the following new paragraph: (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. . (e) Effective date The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2020.

Passed the House of Representatives June 19, 2018. Karen L. Haas, Clerk