Title VI — Other Medicare Provisions

115th Congress · Approved Oct 24, 2018 · 132 Stat. 3894 · Lineage

TITLE VI Other Medicare Provisions

Subtitle A Testing of Incentive Payments for Behavioral Health Providers for Adoption and Use of Certified Electronic Health Record Technology

SEC. 6001. Testing of Incentive Payments for Behavioral Health Providers for Adoption and Use of Certified Electronic Health Record Technology.

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:

“(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))).”

Subtitle B Abuse Deterrent Access

SEC. 6011. Short Title.

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

SEC. 6012. Study on Abuse-Deterrent Opioid Formulations Access Barriers under Medicare.

(a)

In General.— Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study and submit to Congress a report on—

(1)

the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in an MA–PD plan under part C of title XVIII of the Social Security Act or a prescription drug plan under part D of such title of such Act, taking into account any barriers preventing such individuals from accessing such formulations under such MA–PD or part D plans, such as cost-sharing tiers, fail-first requirements, the price of such formulations, and prior authorization requirements; and

(2)

the effectiveness of abuse-deterrent opioid formulations in preventing opioid abuse or misuse; the impact of the use of abuse-deterrent opioid formulations on the use or abuse of other prescription or illicit opioids (including changes in deaths from such opioids); and other public health consequences of the use of abuse-deterrent opioid formulations, such as an increase in rates of human immunodeficiency virus.

(b)

Definition of Abuse-Deterrent Opioid Formulation.— In this section, the term “abuse-deterrent opioid formulation” means an opioid that is a prodrug or that has certain abuse-deterrent properties, such as physical or chemical barriers, agonist or antagonist combinations, aversion properties, delivery system mechanisms, or other features designed to prevent abuse of such opioid.

Subtitle C Medicare Opioid Safety Education

SEC. 6021. Medicare Opioid Safety Education.

(a)

In General.— Section 1804 of the Social Security Act (42 U.S.C. 1395b–2) is amended by adding at the end the following new subsection:

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

“(1) references to educational resources regarding opioid use and pain management;

“(2) a description of categories of alternative, non-opioid pain management treatments covered under this title; and

“(3) a suggestion for the beneficiary to talk to a physician regarding opioid use and pain management.”

(b)

Effective Date.— The amendment made by subsection (a) shall apply to notices distributed prior to each Medicare open enrollment period beginning after January 1, 2019.

Subtitle D Opioid Addiction Action Plan

SEC. 6031. Short Title.

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

SEC. 6032. Action Plan on Recommendations for Changes under Medicare and Medicaid to Prevent Opioids Addictions and Enhance Access to Medication-Assisted Treatment.

(a)

In General.— Not later than January 1, 2020, the Secretary of Health and Human Services (in this section referred to as the “Secretary”), in collaboration with the Pain Management Best Practices Inter-Agency Task Force convened under section 101(b) of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198), shall develop an action plan as described in subsection (b).

(b)

Action Plan Components.— The action plan shall include a review by the Secretary of Medicare and Medicaid payment and coverage policies that may be viewed as potential obstacles to an effective response to the opioid crisis, and recommendations, as determined appropriate by the Secretary, on the following:

(1)

A review of payment and coverage policies under the Medicare program under title XVIII of the Social Security Act and the Medicaid program under title XIX of such Act, including a review of coverage and payment under such programs of all medication-assisted treatment approved by the Food and Drug Administration related to the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse, including in such review, payment under the Medicare prospective payment system for inpatient hospital services under section 1886(d) of such Act (42 U.S.C. 1395ww(d)) and the Medicare prospective payment system for hospital outpatient department services under section 1833(t) of such Act (42 U.S.C. 1395I(t)), to determine whether those payment policies resulted in incentives or disincentives that have contributed to the opioid crisis.

(2)

Recommendations for payment and service delivery models to be tested as appropriate by the Center for Medicare and Medicaid Innovation and other federally authorized demonstration projects, including value-based models, that may encourage the use of appropriate medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse.

(3)

Recommendations for data collection that could facilitate research and policy-making regarding prevention of opioid use disorder as well as data that would aid the Secretary in making coverage and payment decisions under the Medicare and Medicaid programs related to the access to appropriate opioid dependence treatments.

(4)

A review of Medicare and Medicaid beneficiaries’ access to the full range of medication-assisted treatment approved by the Food and Drug Administration for the treatment of opioid use disorder and other therapies that manage chronic and acute pain and treat and minimize risk of opioid misuse and abuse, including access of beneficiaries residing in rural or medically underserved communities.

(5)

A review of payment and coverage policies under the Medicare program and the Medicaid program related to medical devices that are non-opioid based treatments approved by the Food and Drug Administration for the management of acute pain and chronic pain, for monitoring substance use withdrawal and preventing overdoses of controlled substances, and for treating substance use disorder, including barriers to patient access.

(c)

Stakeholder Meetings.—

(1)

In general.— Beginning not later than 3 months after the date of the enactment of this section, the Secretary shall convene a public stakeholder meeting to solicit public comment on the components of the action plan described in subsection (b).

(2)

Participants.— Participants of meetings described in paragraph (1) shall include representatives from the Food and Drug Administration and National Institutes of Health, biopharmaceutical industry members, medical researchers, health care providers, the medical device industry, the Medicare program, the Medicaid program, and patient advocates.

(d)

Request for Information.— Not later than 3 months after the date of the enactment of this section, the Secretary shall issue a request for information seeking public feedback regarding ways in which the Centers for Medicare & Medicaid Services can help address the opioid crisis through the development of and application of the action plan.

(e)

Report to Congress.— Not later than June 1, 2020, the Secretary shall submit to Congress, and make public, a report that includes—

(1)

a summary of the results of the Secretary’s review and any recommendations under the action plan;

(2)

the Secretary’s planned next steps with respect to the action plan; and

(3)

an evaluation of price trends for drugs used to reverse opioid overdoses (such as naloxone), including recommendations on ways to lower such prices for consumers.

(f)

Definition of Medication-Assisted Treatment.— In this section, the term “medication-assisted treatment” includes opioid treatment programs, behavioral therapy, and medications to treat substance abuse disorder.

Subtitle E Advancing High Quality Treatment for Opioid Use Disorders in Medicare

SEC. 6041. Short Title.

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

SEC. 6042. Opioid Use Disorder Treatment Demonstration Program.

Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended by inserting after section 1866E (42 U.S.C. 1395cc–5) the following new section:

“SEC. 1866F. OPIOID USE DISORDER TREATMENT DEMONSTRATION PROGRAM.

“(a) Implementation of 4-Year Demonstration Program.—

“(1) In general.—Not later than January 1, 2021, the Secretary shall implement a 4-year demonstration program under this title (in this section referred to as the ‘Program’) to increase access of applicable beneficiaries to opioid use disorder treatment services, improve physical and mental health outcomes for such beneficiaries, and to the extent possible, reduce expenditures under this title. Under the Program, the Secretary shall make payments under subsection (e) to participants (as defined in subsection (c)(1)(A)) for furnishing opioid use disorder treatment services delivered through opioid use disorder care teams, or arranging for such services to be furnished, to applicable beneficiaries participating in the Program.

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

“(A) means, with respect to an applicable beneficiary, services that are furnished for the treatment of opioid use disorders and that utilize drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act for the treatment of opioid use disorders in an outpatient setting; and

“(B) includes—

“(i) medication-assisted treatment;

“(ii) treatment planning;

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

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

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

“(b) Program Design.—

“(1) In general.—The Secretary shall design the Program in such a manner to allow for the evaluation of the extent to which the Program accomplishes the following purposes:

“(A) Reduces hospitalizations and emergency department visits.

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

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

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

“(E) Reduces deaths from opioid overdose.

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

“(2) Consultation.—In designing the Program, including the criteria under subsection (e)(2)(A), the Secretary shall, not later than 3 months after the date of the enactment of this section, consult with specialists in the field of addiction, clinicians in the primary care community, and beneficiary groups.

“(c) Participants; Opioid Use Disorder Care Teams.—

“(1) Participants.—

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

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

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

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

“(III) a hospital outpatient department;

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

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

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

“(VII) a clinic certified as a certified community behavioral health clinic pursuant to section 223 of the Protecting Access to Medicare Act of 2014; or

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

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

“(iii) that establishes an opioid use disorder care team (as defined in paragraph (2)) through employing or contracting with health care practitioners described in paragraph (2)(A), and uses such team to furnish or arrange for opioid use disorder treatment services in the outpatient setting under the Program.

“(B) Preference.—In selecting participants for the Program, the Secretary shall give preference to individuals and entities that are located in areas with a prevalence of opioid use disorders that is higher than the national average prevalence.

“(2) Opioid use disorder care teams.—

“(A) In general.—For purposes of this section, the term ‘opioid use disorder care team’ means a team of health care practitioners established by a participant described in paragraph (1)(A) that—

“(i) shall include—

“(I) at least one physician (as defined in section 1861(r)(1)) furnishing primary care services or addiction treatment services to an applicable beneficiary; and

“(II) at least one eligible practitioner (as defined in paragraph (3)), who may be a physician who meets the criterion in subclause (I); and

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

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

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

“(ii) meet minimum criteria, as established by the Secretary; and

“(iii) submit to the Secretary, in such form, manner, and frequency as specified by the Secretary, with respect to each applicable beneficiary for whom opioid use disorder treatment services are furnished by the opioid use disorder care team, data and such other information as the Secretary determines appropriate to—

“(I) monitor and evaluate the Program;

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

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

“(3) Eligible practitioner defined.—For purposes of this section, the term ‘eligible practitioner’ means a physician or other health care practitioner, such as a nurse practitioner, that—

“(A) is enrolled under section 1866(j)(1);

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

“(C) 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.

“(d) Participation of Applicable Beneficiaries.—

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

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

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

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

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

“(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.

“(3) Services.—In order to participate in the Program, an applicable beneficiary shall agree to receive opioid use disorder treatment services from a participant. Participation under the Program shall not affect coverage of or payment for any other item or service under this title for the applicable beneficiary.

“(4) Beneficiary access to services.—Nothing in this section shall be construed as encouraging providers to limit applicable beneficiary access to services covered under this title, and applicable beneficiaries shall not be required to relinquish access to any benefit under this title as a condition of receiving services from a participant in the Program.

“(e) Payments.—

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

“(A) In general.—The Secretary shall establish a schedule of per applicable beneficiary per month care management fees. Such a per applicable beneficiary per month care management fee shall be paid to a participant in addition to any other amount otherwise payable under this title to the health care practitioners in the participant’s opioid use disorder care team or, if applicable, to the participant. A participant may use such per applicable beneficiary per month care management fee to deliver additional services to applicable beneficiaries, including services not otherwise eligible for payment under this title.

“(B) Payment amounts.—In carrying out subparagraph (A), the Secretary may—

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

“(ii) pay a higher per applicable beneficiary per month care management fee for an applicable beneficiary who receives more intensive treatment services from a participant and for whom those services are appropriate based on clinical guidelines for opioid use disorder care;

“(iii) pay a higher per applicable beneficiary per month care management fee for the month in which the applicable beneficiary begins treatment with a participant than in subsequent months, to reflect the greater time and costs required for the planning and initiation of treatment, as compared to maintenance of treatment; and

“(iv) take into account whether a participant’s opioid use disorder care team refers applicable beneficiaries to other suppliers or providers for any opioid use disorder treatment services.

“(C) No duplicate payment.—The Secretary shall make payments under this paragraph to only one participant for services furnished to an applicable beneficiary during a calendar month.

“(2) Incentive payments.—

“(A) In general.—Under the Program, the Secretary shall establish a performance-based incentive payment, which shall be paid (using a methodology established and at a time determined appropriate by the Secretary) to participants based on the performance of participants with respect to criteria, as determined appropriate by the Secretary, in accordance with subparagraph (B).

“(B) Criteria.—

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

“(I) Patient engagement and retention in treatment.

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

“(III) Other criteria established by the Secretary.

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

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

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

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

“(f) Multipayer Strategy.—In carrying out the Program, the Secretary shall encourage other payers to provide similar payments and to use similar criteria as applied under the Program under subsection (e)(2)(C). The Secretary may enter into a memorandum of understanding with other payers to align the methodology for payment provided by such a payer related to opioid use disorder treatment services with such methodology for payment under the Program.

“(g) Evaluation.—

“(1) In general.—The Secretary shall conduct an intermediate and final evaluation of the program. Each such evaluation shall determine the extent to which each of the purposes described in subsection (b) have been accomplished under the Program.

“(2) Reports.—The Secretary shall submit to Congress—

“(A) a report with respect to the intermediate evaluation under paragraph (1) not later than 3 years after the date of the implementation of the Program; and

“(B) a report with respect to the final evaluation under paragraph (1) not later than 6 years after such date.

“(h) Funding.—

“(1) Administrative funding.—For the purposes of implementing, administering, and carrying out the Program (other than for purposes described in paragraph (2)), $5,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841.

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

“(3) Availability.—Amounts transferred under this subsection for a fiscal year shall be available until expended.

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

Subtitle F Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment

SEC. 6051. Short Title.

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”.

SEC. 6052. Grants to Provide Technical Assistance to Outlier Prescribers of Opioids.

(a)

Grants Authorized.— The Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall, through the Centers for Medicare & Medicaid Services, award grants, contracts, or cooperative agreements to eligible entities for the purposes described in subsection (b).

(b)

Use of Funds.— Grants, contracts, and cooperative agreements awarded under subsection (a) shall be used to support eligible entities through technical assistance—

(1)

to educate and provide outreach to outlier prescribers of opioids about best practices for prescribing opioids;

(2)

to educate and provide outreach to outlier prescribers of opioids about non-opioid pain management therapies; and

(3)

to reduce the amount of opioid prescriptions prescribed by outlier prescribers of opioids.

(c)

Application.— Each eligible entity seeking to receive a grant, contract, or cooperative agreement under subsection (a) shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require.

(d)

Geographic Distribution.— In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall prioritize establishing technical assistance resources in each State.

(e)

Definitions.— In this section:

(1)

Eligible entity.— The term “eligible entity” means—

(A)

an organization—

(i)

that has demonstrated experience providing technical assistance to health care professionals on a State or regional basis; and

(ii)

that has at least—

(I)

one individual who is a representative of consumers on its governing body; and

(II)

one individual who is a representative of health care providers on its governing body; or

(B)

an entity that is a quality improvement entity with a contract under part B of title XI of the Social Security Act (42 U.S.C. 1320c et seq.).

(2)

Outlier prescriber of opioids.— The term “outlier prescriber of opioids” means, with respect to a period, a prescriber identified by the Secretary under subparagraph (D)(ii) of section 1860D–4(c)(4) of the Social Security Act (42 U.S.C. 1395w–104(c)(4)), as added by section 6065 of this Act, to be an outlier prescriber of opioids for such period.

(3)

Prescribers.— The term “prescriber” means any health care professional, including a nurse practitioner or physician assistant, who is licensed to prescribe opioids by the State or territory in which such professional practices.

(f)

Funding.— For purposes of implementing this section, $75,000,000 shall be available from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C. 1395t), to remain available until expended.

Subtitle G Preventing Addiction for Susceptible Seniors

SEC. 6061. Short Title.

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

SEC. 6062. Electronic Prior Authorization for Covered Part D Drugs.

Section 1860D–4(e)(2) of the Social Security Act (42 U.S.C. 1395w–104(e)(2)) is amended by adding at the end the following new subparagraph:

“(E) Electronic prior authorization.—

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

“(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

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

“(ii) Electronic transmission.—

“(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).

“(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.

“(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.”

SEC. 6063. Program Integrity Transparency Measures under Medicare Parts C and D.

(a)

In General.— Section 1859 of the Social Security Act (42 U.S.C. 1395w–28) is amended by adding at the end the following new subsection:

“(i) Program Integrity Transparency Measures.—

“(1) Program integrity portal.—

“(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)—

“(i) the referral by such plans of substantiated or suspicious activities, as defined by the Secretary, of a provider of services (including a prescriber) or supplier related to fraud, waste, and abuse for initiating or assisting investigations conducted by the eligible entity; and

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

“(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):

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

“(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.

“(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.

“(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 or suspicious activities of fraud, waste, or abuse of a provider of services (including a prescriber) or supplier, if such provider (including a prescriber) 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.

“(C) Rulemaking.—For purposes of this paragraph, the Secretary shall, through rulemaking, specify what constitutes substantiated or suspicious activities of fraud, waste, and abuse, using guidance such as what is provided in the Medicare Program Integrity Manual 4.8. 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.

“(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.

“(2) Quarterly reports.—Beginning not later than 2 years after the date of the 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—

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

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

“(3) Clarification.—Nothing in this subsection shall preclude or otherwise affect referrals to the Inspector General of the Department of Health and Human Services or other law enforcement entities.”

(b)

Contract Requirement to Communicate Plan Corrective Actions Against Opioids Over-prescribers.— Section 1857(e) of the Social Security Act (42 U.S.C. 1395w–27(e)) is amended by adding at the end the following new paragraph:

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

“(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, credible evidence of suspicious activities of a provider of services (including a prescriber) or supplier related to fraud, and other actions taken by such plans related to inappropriate prescribing of opioids.

“(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).

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

“(i) specify a definition for the term ‘inappropriate prescribing’ and a method for determining if a provider of services prescribes inappropriate prescribing; and

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

(c)

Reference Under Part D to Program Integrity Transparency Measures.— Section 1860D–4 of the Social Security Act (42 U.S.C. 1395w–104) is amended by adding at the end the following new subsection:

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

SEC. 6064. Expanding Eligibility for Medication Therapy Management Programs under Part D.

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

(1)

by redesignating subclauses (I) through (III) as items (aa) through (cc), respectively, and adjusting the margins accordingly;

(2)

by striking “ are part D eligible individuals who—” and inserting

“(I) Part D eligible individuals who—”

; and

(3)

by adding at the end the following new subclause:

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

SEC. 6065. Commit to Opioid Medical Prescriber Accountability and Safety for Seniors.

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:

“(D) Notification and additional requirements with respect to outlier prescribers of opioids.—

“(i) Notification.—Not later than January 1, 2021, 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 as specified in accordance with clause (iii).

“(ii) Identification of outlier prescribers of opioids.—

“(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 thresholds established under subclause (II), identify prescribers that are outlier opioids prescribers for a period of time specified by the Secretary.

“(II) Establishment of thresholds.—For purposes of subclause (I) and subject to subclause (III), the Secretary shall, after consultation with stakeholders, establish thresholds, 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.

“(III) Exclusions.—The following shall not be included in the analysis for identifying outlier prescribers of opioids under this clause:

“(aa) Claims for covered part D drugs for part D eligible individuals who are receiving hospice care under this title.

“(bb) Claims for covered part D drugs for part D eligible individuals who are receiving oncology services under this title.

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

“(iii) Contents of notification.—The Secretary shall include the following information in the notifications provided under clause (i):

“(I) Information on how such prescriber compares to other prescribers within the same specialty and geographic area.

“(II) Information on opioid prescribing guidelines, based on input from stakeholders, that may include the Centers for Disease Control and Prevention guidelines for prescribing opioids for chronic pain and guidelines developed by physician organizations.

“(III) Other information determined appropriate by the Secretary.

“(iv) Modifications and expansions.—

“(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 and changes in opioid prescribing utilization and trends.

“(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.

“(v) Additional requirements for persistent outlier prescribers.—In the case of a prescriber who the Secretary determines is persistently identified under clause (ii) as an outlier prescriber of opioids, the following shall apply:

“(I) Such prescriber may be required to enroll in the program under this title under section 1866(j) if such prescriber is not otherwise required to enroll, but only after other appropriate remedies have been provided, such as the provision of education funded through section 6052 of the SUPPORT for Patients and Communities Act, for a period determined by the Secretary as sufficient to correct the prescribing patterns that lead to identification of such prescriber as a persistent outlier prescriber of opioids. The Secretary shall determine the length of the period for which such prescriber is required to maintain such enrollment, which shall be the minimum period necessary to correct such prescribing patterns.

“(II) Not less frequently than annually (and in a form and manner determined appropriate by the Secretary), the Secretary, consistent with clause(iv)(I), shall communicate information on such prescribers to sponsors of a prescription drug plan and Medicare Advantage organizations offering an MA–PD plan.

“(vi) Public availability of information.—The Secretary shall make aggregate information under this subparagraph available on the internet website of the Centers for Medicare & Medicaid Services. Such information shall be in a form and manner determined appropriate by the Secretary and shall not identify any specific prescriber. In carrying out this clause, the Secretary shall consult with interested stakeholders.

“(vii) Opioids defined.—For purposes of this subparagraph, the term ‘opioids’ has such meaning as specified by the Secretary.

“(viii) Other activities.—Nothing in this subparagraph shall preclude the Secretary from conducting activities that provide prescribers with information as to how they compare to other prescribers that are in addition to the activities under this subparagraph, including activities that were being conducted as of the date of the enactment of this subparagraph.”

SEC. 6066. No Additional Funds Authorized.

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.

Subtitle H Expanding Oversight of Opioid Prescribing and Payment

SEC. 6071. Short Title.

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

SEC. 6072. Medicare Payment Advisory Commission Report on Opioid Payment, Adverse Incentives, and Data under the Medicare Program.

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:

(1)

A description of how the Medicare program pays for pain management treatments (both opioid and non-opioid pain management alternatives) in both inpatient and outpatient hospital settings.

(2)

The identification of incentives under the hospital inpatient prospective payment system under section 1886 of the Social Security Act (42 U.S.C. 1395ww) and incentives under the hospital outpatient prospective payment system under section 1833(t) of such Act (42 U.S.C. 1395l(t)) for prescribing opioids and incentives under each such system for prescribing non-opioid treatments, and recommendations as the Commission deems appropriate for addressing any of such incentives that are adverse incentives.

(3)

A description of how opioid use is tracked and monitored through Medicare claims data and other mechanisms and the identification of any areas in which further data and methods are needed for improving data and understanding of opioid use.

SEC. 6073. No Additional Funds Authorized.

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.

Subtitle I Dr. Todd Graham Pain Management, Treatment, and Recovery

SEC. 6081. Short Title.

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

SEC. 6082. 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. 6083. 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. 6084. 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. 6085. 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)), as amended by section 6001, is further amended by adding at the end the following new clauses:

“(xxvi) 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)).

“(xxvii) 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. 6086. Dr. Todd Graham 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)

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 (E) 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 Department of Veterans Affairs 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.

Subtitle J Combating Opioid Abuse for Care in Hospitals

SEC. 6091. Short Title.

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

SEC. 6092. Developing Guidance on Pain Management and Opioid Use Disorder Prevention for Hospitals Receiving Payment under Part a of the Medicare Program.

(a)

In General.— Not later than July 1, 2019, the Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall develop and publish on the public website of the Centers for Medicare & Medicaid Services guidance for hospitals receiving payment under part A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.) on pain management strategies and opioid use disorder prevention strategies with respect to individuals entitled to benefits under such part.

(b)

Consultation.— In developing the guidance described in subsection (a), the Secretary shall consult with relevant stakeholders, including—

(1)

medical professional organizations;

(2)

providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act (42 U.S.C. 1395x));

(3)

health care consumers or groups representing such consumers; and

(4)

other entities determined appropriate by the Secretary.

(c)

Contents.— The guidance described in subsection (a) shall include, with respect to hospitals and individuals described in such subsection, the following:

(1)

Best practices regarding evidence-based screening and practitioner education initiatives relating to screening and treatment protocols for opioid use disorder, including—

(A)

methods to identify such individuals at-risk of opioid use disorder, including risk stratification;

(B)

ways to prevent, recognize, and treat opioid overdoses; and

(C)

resources available to such individuals, such as opioid treatment programs, peer support groups, and other recovery programs.

(2)

Best practices for such hospitals to educate practitioners furnishing items and services at such hospital with respect to pain management and substance use disorders, including education on—

(A)

the adverse effects of prolonged opioid use;

(B)

non-opioid, evidence-based, non-pharmacological pain management treatments;

(C)

monitoring programs for individuals who have been prescribed opioids; and

(D)

the prescribing of naloxone along with an initial opioid prescription.

(3)

Best practices for such hospitals to make such individuals aware of the risks associated with opioid use (which may include use of the notification template described in paragraph (4)).

(4)

A notification template developed by the Secretary, for use as appropriate, for such individuals who are prescribed an opioid that—

(A)

explains the risks and side effects associated with opioid use (including the risks of addiction and overdose) and the importance of adhering to the prescribed treatment regimen, avoiding medications that may have an adverse interaction with such opioid, and storing such opioid safely and securely;

(B)

highlights multimodal and evidence-based non-opioid alternatives for pain management;

(C)

encourages such individuals to talk to their health care providers about such alternatives;

(D)

provides for a method (through signature or otherwise) for such an individual, or person acting on such individual’s behalf, to acknowledge receipt of such notification template;

(E)

is worded in an easily understandable manner and made available in multiple languages determined appropriate by the Secretary; and

(F)

includes any other information determined appropriate by the Secretary.

(5)

Best practices for such hospital to track opioid prescribing trends by practitioners furnishing items and services at such hospital, including—

(A)

ways for such hospital to establish target levels, taking into account the specialties of such practitioners and the geographic area in which such hospital is located, with respect to opioids prescribed by such practitioners;

(B)

guidance on checking the medical records of such individuals against information included in prescription drug monitoring programs;

(C)

strategies to reduce long-term opioid prescriptions; and

(D)

methods to identify such practitioners who may be over-prescribing opioids.

(6)

Other information the Secretary determines appropriate, including any such information from the Opioid Safety Initiative established by the Department of Veterans Affairs or the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration.

SEC. 6093. Requiring the Review of Quality Measures Relating to Opioids and Opioid Use Disorder Treatments Furnished under the Medicare Program and Other Federal Health Care Programs.

Section 1890A of the Social Security Act (42 U.S.C. 1395aaa–1) is amended by adding at the end the following new subsection:

“(g) Technical Expert Panel Review of Opioid and Opioid Use Disorder Quality Measures.—

“(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.

“(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—

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

“(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

“(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).

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

“(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

“(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).

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

“(5) Prioritization of measure endorsement.—The Secretary—

“(A) during the period beginning on the date of the enactment of this subsection and ending on December 31, 2023, shall prioritize the endorsement of measures relating to opioids and opioid use disorders by the entity with a contract under subsection (a) of section 1890 in connection with endorsement of measures described in subsection (b)(2) of such section; and

“(B) on and after January 1, 2024, may prioritize the endorsement of such measures by such entity.”

SEC. 6094. Technical Expert Panel on Reducing Surgical Setting Opioid Use; Data Collection on Perioperative Opioid Use.

(a)

Technical Expert Panel on Reducing Surgical Setting Opioid Use.—

(1)

In general.— Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a technical expert panel, including medical and surgical specialty societies and hospital organizations, to provide recommendations on reducing opioid use in the inpatient and outpatient surgical settings and on best practices for pain management, including with respect to the following:

(A)

Approaches that limit patient exposure to opioids during the perioperative period, including pre-surgical and post-surgical injections, and that identify such patients at risk of opioid use disorder pre-operation.

(B)

Shared decision making with patients and families on pain management, including a review of payment to ensure payment under the Medicare program under title XVIII of the Social Security Act accounts for time spent on shared decision making.

(C)

Education on the safe use, storage, and disposal of opioids.

(D)

Prevention of opioid misuse and abuse after discharge.

(E)

Development of a clinical algorithm to identify and treat at-risk, opiate-tolerant patients and reduce reliance on opioids for acute pain during the perioperative period.

(2)

Report.— Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress and make public a report containing the recommendations developed under paragraph (1) and an action plan for broader implementation of pain management protocols that limit the use of opioids in the perioperative setting and upon discharge from such setting.

(b)

Data Collection on Perioperative Opioid Use.— Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that contains the following:

(1)

The diagnosis-related group codes identified by the Secretary as having the highest volume of surgeries.

(2)

With respect to each of such diagnosis-related group codes so identified, a determination by the Secretary of the data that is both available and reported on opioid use following such surgeries, such as with respect to—

(A)

surgical volumes, practices, and opioid prescribing patterns;

(B)

opioid consumption, including—

(i)

perioperative days of therapy;

(ii)

average daily dose at the hospital, including dosage greater than 90 milligram morphine equivalent;

(iii)

post-discharge prescriptions and other combination drugs that are used before intervention and after intervention;

(iv)

quantity and duration of opioid prescription at discharge; and

(v)

quantity consumed and number of refills;

(C)

regional anesthesia and analgesia practices, including pre-surgical and post-surgical injections;

(D)

naloxone reversal;

(E)

post-operative respiratory failure;

(F)

information about storage and disposal; and

(G)

such other information as the Secretary may specify.

(3)

Recommendations for improving data collection on perioperative opioid use, including an analysis to identify and reduce barriers to collecting, reporting, and analyzing the data described in paragraph (2), including barriers related to technological availability.

SEC. 6095. Requiring the Posting and Periodic Update of Opioid Prescribing Guidance for Medicare Beneficiaries.

(a)

In General.— Not later than 180 days 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 post on the public website of the Centers for Medicare & Medicaid Services all guidance published by the Department of Health and Human Services on or after January 1, 2016, relating to the prescribing of opioids and applicable to opioid prescriptions for individuals entitled to benefits under part A of title XVIII of the Social Security Act (42 U.S.C. 1395c et seq.) or enrolled under part B of such title of such Act (42 U.S.C. 1395j et seq.).

(b)

Update of Guidance.—

(1)

Periodic update.— The Secretary shall, in consultation with the entities specified in paragraph (2), periodically (as determined appropriate by the Secretary) update guidance described in subsection (a) and revise the posting of such guidance on the website described in such subsection.

(2)

Consultation.— The entities specified in this paragraph are the following:

(A)

Medical professional organizations.

(B)

Providers and suppliers of services (as such terms are defined in section 1861 of the Social Security Act (42 U.S.C. 1395x)).

(C)

Health care consumers or groups representing such consumers.

(D)

Other entities determined appropriate by the Secretary.

Subtitle K Providing Reliable Options for Patients and Educational Resources

SEC. 6101. Short Title.

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

SEC. 6102. Requiring Medicare Advantage Plans and Part D Prescription Drug Plans to Include Information on Risks Associated with Opioids and Coverage of Nonpharmacological Therapies and Nonopioid Medications or Devices Used to Treat Pain.

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

(1)

in subparagraph (A), by inserting “ , subject to subparagraph (C),” before “ including”;

(2)

in subparagraph (B), by adding at the end the following new clause:

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

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

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

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

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

; and

(3)

by adding at the end the following new subparagraph:

“(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.”

SEC. 6103. Requiring Medicare Advantage Plans and Prescription Drug Plans to Provide Information on the Safe Disposal of Prescription Drugs.

(a)

Medicare Advantage.— Section 1852 of the Social Security Act (42 U.S.C. 1395w–22) is amended by adding at the end the following new subsection:

“(n) Provision of Information Relating to the Safe Disposal of Certain Prescription Drugs.—

“(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.

“(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.”

(b)

Prescription Drug Plans.— Section 1860D–4(c)(2)(B) of the Social Security Act (42 U.S.C. 1395w–104(c)(2)(B)) is amended—

(1)

by striking “ may include elements that promote”;

(2)

by redesignating clauses (i) through (iii) as subclauses (I) through (III) and adjusting the margins accordingly;

(3)

by inserting before subclause (I), as so redesignated, the following new clause:

“(i) may include elements that promote—”

(4)

in subclause (III), as so redesignated, by striking the period at the end and inserting “ ; and”; and

(5)

by adding at the end the following new clause:

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

“(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

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

SEC. 6104. Revising Measures Used under the Hospital Consumer Assessment of Healthcare Providers and Systems Survey Relating to Pain Management.

(a)

Restriction on the Use of Pain Questions in HCAHPS.— Section 1886(b)(3)(B)(viii) of the Social Security Act (42 U.S.C. 1395ww(b)(3)(B)(viii)) is amended by adding at the end the following new subclause:

“(XII)

(aa) With respect to a Hospital Consumer Assessment of Healthcare Providers and Systems survey (or a successor survey) conducted on or after January 1, 2020, 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.

“(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 or 2019 about communication by hospital staff with an individual about such individual’s pain.”

(b)

Restriction on Use of 2018 and 2019 Pain Questions in the Hospital Value-based Purchasing Program.— Section 1886(o)(2)(B) of the Social Security Act (42 U.S.C. 1395ww(o)(2)(B)) is amended by adding at the end the following new clause:

“(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 or 2019 about communication by hospital staff with an individual about the individual’s pain.”

Subtitle L Fighting the Opioid Epidemic With Sunshine

SEC. 6111. Fighting the Opioid Epidemic with Sunshine.

(a)

Inclusion of Information Regarding Payments to Additional Practitioners.—

(1)

In general.— Section 1128G(e)(6) of the Social Security Act (42 U.S.C. 1320a–7h(e)(6)) is amended—

(A)

in subparagraph (A), by adding at the end the following new clauses:

“(iii) A physician assistant, nurse practitioner, or clinical nurse specialist (as such terms are defined in section 1861(aa)(5)).

“(iv) A certified registered nurse anesthetist (as defined in section 1861(bb)(2)).

“(v) A certified nurse-midwife (as defined in section 1861(gg)(2)).”

; and

(B)

in subparagraph (B), by inserting “ , physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, or certified nurse-midwife” after “ physician”.

(2)

Effective date.— The amendments made by this subsection shall apply with respect to information required to be submitted under section 1128G of the Social Security Act (42 U.S.C. 1320a–7h) on or after January 1, 2022.

(b)

Sunset of Exclusion of National Provider Identifier of Covered Recipient in Information Made Publicly Available.— Section 1128G(c)(1)(C)(viii) of the Social Security Act (42 U.S.C. 1320a–7h(c)(1)(C)(viii)) is amended by striking “ does not contain” and inserting “ in the case of information made available under this subparagraph prior to January 1, 2022, does not contain”.

(c)

Administration.— Chapter 35 of title 44, United States Code, shall not apply to this section or the amendments made by this section.

Lineage

Oct 24, 2018reading now Pub. L. 115–271 Enacted
Oct 24, 2018 H.R. 6 · Enrolled Bill Congress
Sep 28, 2018 H.R. 6 · Engrossed Amendment House House
Sep 17, 2018 H.R. 6 · Engrossed Amendment Senate Senate
Jun 25, 2018 H.R. 6 · Placed on Calendar Senate Senate Received; read the first time
Jun 21, 2018 H.R. 6 · Engrossed in House House
Jun 13, 2018 H.R. 6 · Introduced in House House Mr. Walden (for himself, Mr. Pallone, Mr. Brady of Texas, Mr. Neal, Mr. Roe of Tennessee, Mr. Shuster, Ms. Foxx, Mr. Goodlatte, Mr. Walz, Mr. DeFazio, and Mr. Burgess) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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