Title: Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018
Policy area: Health

Summary:
Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018
This bill establishes several requirements for the Centers for Medicare & Medicaid Services (CMS), and alters requirements under Medicare and Medicare Advantage (MA), related to pain management and opioid use.
Among other requirements, the CMS must review payments under Medicare for opioid and non-opioid pain management procedures, specifically with respect to ambulatory outpatient surgical procedures and hospital outpatient department services. The CMS must ensure that there are no payment incentives for using opioids instead of non-opioid alternatives and must make revisions accordingly.
The bill also requires payment under Medicare to federally qualified health centers and rural health clinics that have health care practitioners who are newly certified to provide medication-assisted treatment (e.g., buprenorphine).
The bill also authorizes the suspension of payments to a pharmacy under the Medicare prescription drug benefit and MA prescription drug plans pending the investigation of a credible allegation of fraud by the pharmacy.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6110 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                H. R. 6110

  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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 14, 2018

Mrs. Walorski (for herself, Ms. Judy Chu of California, Mrs. Noem, Mr. 
  Marchant, Ms. Sanchez, Mr. Blumenauer, Mr. Rothfus, Mr. Roskam, Mr. 
MacArthur, and Mr. Danny K. Davis of Illinois) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
  in addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
  To amend title XVIII of the Social Security Act to provide for 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Dr. Todd Graham Pain Management, 
Treatment, and Recovery Act of 2018''.

SEC. 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).''.

SEC. 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, 
                $6,000,000, 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, $2,000,000, which shall 
        remain available until expended.''.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.
                                 <all>