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H.R. 6 (115th): SUPPORT for Patients and Communities Act

The text of the bill below is as of Oct 5, 2018 (Passed Congress).


I

One Hundred Fifteenth Congress of the United States of America

At the Second Session

H. R. 6

AN ACT

To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act.

(b)

Table of contents

The table of contents of this Act is as follows:

Sec. 1. Short title; table of contents.

Title I—Medicaid Provisions to Address the Opioid Crisis

Sec. 1001. At-risk youth Medicaid protection.

Sec. 1002. Health insurance for former foster youth.

Sec. 1003. Demonstration project to increase substance use provider capacity under the Medicaid program.

Sec. 1004. Medicaid drug review and utilization.

Sec. 1005. Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder.

Sec. 1006. Medicaid health homes for substance-use-disorder Medicaid enrollees.

Sec. 1007. Caring recovery for infants and babies.

Sec. 1008. Peer support enhancement and evaluation review.

Sec. 1009. Medicaid substance use disorder treatment via telehealth.

Sec. 1010. Enhancing patient access to non-opioid treatment options.

Sec. 1011. Assessing barriers to opioid use disorder treatment.

Sec. 1012. Help for moms and babies.

Sec. 1013. Securing flexibility to treat substance use disorders.

Sec. 1014. MACPAC study and report on MAT utilization controls under State Medicaid programs.

Sec. 1015. Opioid addiction treatment programs enhancement.

Sec. 1016. Better data sharing to combat the opioid crisis.

Sec. 1017. Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid.

Sec. 1018. Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid.

Title II—Medicare Provisions to Address the Opioid Crisis

Sec. 2001. Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders.

Sec. 2002. Comprehensive screenings for seniors.

Sec. 2003. Every prescription conveyed securely.

Sec. 2004. Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries.

Sec. 2005. Medicare coverage of certain services furnished by opioid treatment programs.

Sec. 2006. Encouraging appropriate prescribing under Medicare for victims of opioid overdose.

Sec. 2007. Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries.

Sec. 2008. Suspension of payments by Medicare prescription drug plans and MA–PD plans pending investigations of credible allegations of fraud by pharmacies.

Title III—FDA and Controlled Substance Provisions

Subtitle A—FDA provisions

Chapter 1—In general

Sec. 3001. Clarifying FDA regulation of non-addictive pain products.

Sec. 3002. Evidence-based opioid analgesic prescribing guidelines and report.

Chapter 2—Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now

Sec. 3011. Short title.

Sec. 3012. Notification, nondistribution, and recall of controlled substances.

Sec. 3013. Single source pattern of imported illegal drugs.

Sec. 3014. Strengthening FDA and CBP coordination and capacity.

Chapter 3—Stop Illicit Drug Importation

Sec. 3021. Short title.

Sec. 3022. Restricting entrance of illicit drugs.

Chapter 4—Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging

Sec. 3031. Short title.

Sec. 3032. Safety-enhancing packaging and disposal features.

Chapter 5—Postapproval study requirements

Sec. 3041. Clarifying FDA postmarket authorities.

Subtitle B—Controlled substance provisions

Chapter 1—More flexibility with respect to medication-Assisted treatment for opioid use disorders

Sec. 3201. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders.

Sec. 3202. Medication-assisted treatment for recovery from substance use disorder.

Sec. 3203. Grants to enhance access to substance use disorder treatment.

Sec. 3204. Delivery of a controlled substance by a pharmacy to be administered by injection or implantation.

Chapter 2—Empowering Pharmacists in the Fight Against Opioid Abuse

Sec. 3211. Short title.

Sec. 3212. Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription.

Chapter 3—Safe Disposal of Unused Medication

Sec. 3221. Short title.

Sec. 3222. Disposal of controlled substances of a hospice patient by employees of a qualified hospice program.

Sec. 3223. GAO study and report on hospice safe drug management.

Chapter 4—Special Registration for Telemedicine Clarification

Sec. 3231. Short title.

Sec. 3232. Regulations relating to a special registration for telemedicine.

Chapter 5—Synthetic Abuse and Labeling of Toxic Substances

Sec. 3241. Controlled substance analogues.

Chapter 6—Access to Increased Drug Disposal

Sec. 3251. Short title.

Sec. 3252. Definitions.

Sec. 3253. Authority to make grants.

Sec. 3254. Application.

Sec. 3255. Use of grant funds.

Sec. 3256. Eligibility for grant.

Sec. 3257. Duration of grants.

Sec. 3258. Accountability and oversight.

Sec. 3259. Duration of program.

Sec. 3260. Authorization of appropriations.

Chapter 7—Using Data To Prevent Opioid Diversion

Sec. 3271. Short title.

Sec. 3272. Purpose.

Sec. 3273. Amendments.

Sec. 3274. Report.

Chapter 8—Opioid Quota Reform

Sec. 3281. Short title.

Sec. 3282. Strengthening considerations for DEA opioid quotas.

Chapter 9—Preventing Drug Diversion

Sec. 3291. Short title.

Sec. 3292. Improvements to prevent drug diversion.

Title IV—Offsets

Sec. 4001. Promoting value in Medicaid managed care.

Sec. 4002. Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program.

Sec. 4003. Additional religious exemption from health coverage responsibility requirement.

Sec. 4004. Modernizing the reporting of biological and biosimilar products.

Title V—Other Medicaid Provisions

Subtitle A—Mandatory reporting with respect to adult behavioral health measures

Sec. 5001. Mandatory reporting with respect to adult behavioral health measures.

Subtitle B—Medicaid IMD Additional Info

Sec. 5011. Short title.

Sec. 5012. MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid.

Subtitle C—CHIP Mental Health and Substance Use Disorder Parity

Sec. 5021. Short title.

Sec. 5022. Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program.

Subtitle D—Medicaid Reentry

Sec. 5031. Short title.

Sec. 5032. Promoting State innovations to ease transitions integration to the community for certain individuals.

Subtitle E—Medicaid Partnership

Sec. 5041. Short title.

Sec. 5042. Medicaid providers are required to note experiences in record systems to help in-need patients.

Subtitle F—IMD CARE Act

Sec. 5051. Short title.

Sec. 5052. State option to provide Medicaid coverage for certain individuals with substance use disorders who are patients in certain institutions for mental diseases.

Subtitle G—Medicaid Improvement Fund

Sec. 5061. Medicaid Improvement Fund.

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.

Subtitle B—Abuse Deterrent Access

Sec. 6011. Short title.

Sec. 6012. Study on abuse-deterrent opioid formulations access barriers under Medicare.

Subtitle C—Medicare Opioid Safety Education

Sec. 6021. Medicare opioid safety education.

Subtitle D—Opioid Addiction Action Plan

Sec. 6031. Short title.

Sec. 6032. Action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment.

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

Sec. 6041. Short title.

Sec. 6042. Opioid use disorder treatment demonstration program.

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

Sec. 6051. Short title.

Sec. 6052. Grants to provide technical assistance to outlier prescribers of opioids.

Subtitle G—Preventing Addiction for Susceptible Seniors

Sec. 6061. Short title.

Sec. 6062. Electronic prior authorization for covered part D drugs.

Sec. 6063. Program integrity transparency measures under Medicare parts C and D.

Sec. 6064. Expanding eligibility for medication therapy management programs under part D.

Sec. 6065. Commit to opioid medical prescriber accountability and safety for seniors.

Sec. 6066. No additional funds authorized.

Subtitle H—Expanding Oversight of Opioid Prescribing and Payment

Sec. 6071. Short title.

Sec. 6072. Medicare Payment Advisory Commission report on opioid payment, adverse incentives, and data under the Medicare program.

Sec. 6073. No additional funds authorized.

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

Sec. 6081. Short title.

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.

Sec. 6083. Expanding access under the Medicare program to addiction treatment in Federally qualified health centers and rural health clinics.

Sec. 6084. Studying the availability of supplemental benefits designed to treat or prevent substance use disorders under Medicare Advantage plans.

Sec. 6085. Clinical psychologist services models under the Center for Medicare and Medicaid Innovation; GAO study and report.

Sec. 6086. Dr. Todd Graham pain management study.

Subtitle J—Combating Opioid Abuse for Care in Hospitals

Sec. 6091. Short title.

Sec. 6092. Developing guidance on pain management and opioid use disorder prevention for hospitals receiving payment under part A of the Medicare program.

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.

Sec. 6094. Technical expert panel on reducing surgical setting opioid use; Data collection on perioperative opioid use.

Sec. 6095. Requiring the posting and periodic update of opioid prescribing guidance for Medicare beneficiaries.

Subtitle K—Providing Reliable Options for Patients and Educational Resources

Sec. 6101. Short title.

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.

Sec. 6103. Requiring Medicare Advantage plans and prescription drug plans to provide information on the safe disposal of prescription drugs.

Sec. 6104. Revising measures used under the Hospital Consumer Assessment of Healthcare Providers and Systems survey relating to pain management.

Subtitle L—Fighting the Opioid Epidemic With Sunshine

Sec. 6111. Fighting the opioid epidemic with sunshine.

Title VII—Public Health Provisions

Subtitle A—Awareness and training

Sec. 7001. Report on effects on public health of synthetic drug use.

Sec. 7002. First responder training.

Subtitle B—Pilot program for public health laboratories To detect fentanyl and other synthetic opioids

Sec. 7011. Pilot program for public health laboratories to detect fentanyl and other synthetic opioids.

Subtitle C—Indexing Narcotics, Fentanyl, and Opioids

Sec. 7021. Establishment of substance use disorder information dashboard.

Sec. 7022. Interdepartmental Substance Use Disorders Coordinating Committee.

Sec. 7023. National milestones to measure success in curtailing the opioid crisis.

Sec. 7024. Study on prescribing limits.

Subtitle D—Ensuring Access to Quality Sober Living

Sec. 7031. National recovery housing best practices.

Subtitle E—Advancing Cutting Edge Research

Sec. 7041. Unique research initiatives.

Sec. 7042. Pain research.

Subtitle F—Jessie’s Law

Sec. 7051. Inclusion of opioid addiction history in patient records.

Sec. 7052. Communication with families during emergencies.

Sec. 7053. Development and dissemination of model training programs for substance use disorder patient records.

Subtitle G—Protecting Pregnant Women and Infants

Sec. 7061. Report on addressing maternal and infant health in the opioid crisis.

Sec. 7062. Protecting moms and infants.

Sec. 7063. Early interventions for pregnant women and infants.

Sec. 7064. Prenatal and postnatal health.

Sec. 7065. Plans of safe care.

Subtitle H—Substance Use Disorder Treatment Workforce

Sec. 7071. Loan repayment program for substance use disorder treatment workforce.

Sec. 7072. Clarification regarding service in schools and other community-based settings.

Sec. 7073. Programs for health care workforce.

Subtitle I—Preventing Overdoses While in Emergency Rooms

Sec. 7081. Program to support coordination and continuation of care for drug overdose patients.

Subtitle J—Alternatives to Opioids in the Emergency Department

Sec. 7091. Emergency department alternatives to opioids demonstration program.

Subtitle K—Treatment, Education, and Community Help To Combat Addiction

Sec. 7101. Establishment of regional centers of excellence in substance use disorder education.

Sec. 7102. Youth prevention and recovery.

Subtitle L—Information from National Mental Health and Substance Use Policy Laboratory

Sec. 7111. Information from National Mental Health and Substance Use Policy Laboratory.

Subtitle M—Comprehensive Opioid Recovery Centers

Sec. 7121. Comprehensive opioid recovery centers.

Subtitle N—Trauma-Informed Care

Sec. 7131. CDC surveillance and data collection for child, youth, and adult trauma.

Sec. 7132. Task force to develop best practices for trauma-informed identification, referral, and support.

Sec. 7133. National Child Traumatic Stress Initiative.

Sec. 7134. Grants to improve trauma support services and mental health care for children and youth in educational settings.

Sec. 7135. Recognizing early childhood trauma related to substance abuse.

Subtitle O—Eliminating Opioid Related Infectious Diseases

Sec. 7141. Reauthorization and expansion of program of surveillance and education regarding infections associated with illicit drug use and other risk factors.

Subtitle P—Peer Support Communities of Recovery

Sec. 7151. Building communities of recovery.

Sec. 7152. Peer support technical assistance center.

Subtitle Q—Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies

Sec. 7161. Preventing overdoses of controlled substances.

Sec. 7162. Prescription drug monitoring program.

Subtitle R—Review of substance use disorder treatment providers receiving Federal funding

Sec. 7171. Review of substance use disorder treatment providers receiving Federal funding.

Subtitle S—Other health provisions

Sec. 7181. State response to the opioid abuse crisis.

Sec. 7182. Report on investigations regarding parity in mental health and substance use disorder benefits.

Sec. 7183. CAREER Act.

Title VIII—Miscellaneous

Subtitle A—Synthetics Trafficking and Overdose Prevention

Sec. 8001. Short title.

Sec. 8002. Customs fees.

Sec. 8003. Mandatory advance electronic information for postal shipments.

Sec. 8004. International postal agreements.

Sec. 8005. Cost recoupment.

Sec. 8006. Development of technology to detect illicit narcotics.

Sec. 8007. Civil penalties for postal shipments.

Sec. 8008. Report on violations of arrival, reporting, entry, and clearance requirements and falsity or lack of manifest.

Sec. 8009. Effective date; regulations.

Subtitle B—Opioid Addiction Recovery Fraud Prevention

Sec. 8021. Short title.

Sec. 8022. Definitions.

Sec. 8023. Unfair or deceptive acts or practices with respect to substance use disorder treatment service and products.

Subtitle C—Addressing economic and workforce impacts of the opioid crisis

Sec. 8041. Addressing economic and workforce impacts of the opioid crisis.

Subtitle D—Peer support counseling program for women veterans

Sec. 8051. Peer support counseling program for women veterans.

Subtitle E—Treating Barriers to Prosperity

Sec. 8061. Short title.

Sec. 8062. Drug abuse mitigation initiative.

Subtitle F—Pilot program to help individuals in recovery from a substance use disorder become stably housed

Sec. 8071. Pilot program to help individuals in recovery from a substance use disorder become stably housed.

Subtitle G—Human Services

Sec. 8081. Supporting family-focused residential treatment.

Sec. 8082. Improving recovery and reunifying families.

Sec. 8083. Building capacity for family-focused residential treatment.

Subtitle H—Reauthorizing and Extending Grants for Recovery from Opioid Use Programs

Sec. 8091. Short title.

Sec. 8092. Reauthorization of the comprehensive opioid abuse grant program.

Subtitle I—Fighting Opioid Abuse in Transportation

Sec. 8101. Short title.

Sec. 8102. Alcohol and controlled substance testing of mechanical employees.

Sec. 8103. Department of Transportation public drug and alcohol testing database.

Sec. 8104. GAO report on Department of Transportation’s collection and use of drug and alcohol testing data.

Sec. 8105. Transportation Workplace Drug and Alcohol Testing Program; addition of fentanyl and other substances.

Sec. 8106. Status reports on hair testing guidelines.

Sec. 8107. Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid.

Sec. 8108. Electronic recordkeeping.

Sec. 8109. Status reports on Commercial Driver's License Drug and Alcohol Clearinghouse.

Subtitle J—Eliminating Kickbacks in Recovery

Sec. 8121. Short title.

Sec. 8122. Criminal penalties.

Subtitle K—Substance Abuse Prevention

Sec. 8201. Short title.

Sec. 8202. Reauthorization of the Office of National Drug Control Policy.

Sec. 8203. Reauthorization of the Drug-Free Communities Program.

Sec. 8204. Reauthorization of the National Community Anti-Drug Coalition Institute.

Sec. 8205. Reauthorization of the High-Intensity Drug Trafficking Area Program.

Sec. 8206. Reauthorization of drug court program.

Sec. 8207. Drug court training and technical assistance.

Sec. 8208. Drug overdose response strategy.

Sec. 8209. Protecting law enforcement officers from accidental exposure.

Sec. 8210. COPS Anti-Meth Program.

Sec. 8211. COPS anti-heroin task force program.

Sec. 8212. Comprehensive Addiction and Recovery Act education and awareness.

Sec. 8213. Reimbursement of substance use disorder treatment professionals.

Sec. 8214. Sobriety Treatment and Recovery Teams (START).

Sec. 8215. Provider education.

Sec. 8216. Definitions.

Sec. 8217. Amendments to administration of the Office.

Sec. 8218. Emerging threats committee, plan, and media campaign.

Sec. 8219. Drug interdiction.

Sec. 8220. GAO Audit.

Sec. 8221. National Drug Control Strategy.

Sec. 8222. Technical and conforming amendments to the Office of National Drug Control Policy Reauthorization Act of 1998.

Subtitle L—Budgetary effects

Sec. 8231. Budgetary effect.

I

Medicaid Provisions to Address the Opioid Crisis

1001.

At-risk youth Medicaid protection

(a)

In general

Section 1902 of the Social Security Act (42 U.S.C. 1396a) is amended—

(1)

in subsection (a)—

(A)

by striking and at the end of paragraph (82);

(B)

by striking the period at the end of paragraph (83) and inserting ; and; and

(C)

by inserting after paragraph (83) the following new paragraph:

(84)

provide that—

(A)

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

(B)

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

(C)

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

; and

(2)

by adding at the end the following new subsection:

(nn)

Juvenile; eligible juvenile; public institution

For purposes of subsection (a)(84) and this subsection:

(1)

Juvenile

The term juvenile means an individual who is—

(A)

under 21 years of age; or

(B)

described in subsection (a)(10)(A)(i)(IX).

(2)

Eligible juvenile

The term eligible juvenile means a juvenile who is an inmate of a public institution and who—

(A)

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

(B)

is determined eligible for such medical assistance while an inmate of a public institution.

(3)

Inmate of a public institution

The term inmate of a public institution has the meaning given such term for purposes of applying the subdivision (A) following paragraph (30) of section 1905(a), taking into account the exception in such subdivision for a patient of a medical institution.

.

(b)

No change in exclusion from medical assistance for inmates of public institutions

Nothing in this section shall be construed as changing the exclusion from medical assistance under the subdivision (A) following paragraph (30) of section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)), as redesignated by section 1006(b)(2)(B) of this Act, including any applicable restrictions on a State submitting claims for Federal financial participation under title XIX of such Act for such assistance.

(c)

No change in continuity of eligibility before adjudication or sentencing

Nothing in this section shall be construed to mandate, encourage, or suggest that a State suspend or terminate coverage for individuals before they have been adjudicated or sentenced.

(d)

Effective date

(1)

In general

Except as provided in paragraph (2), the amendments made by subsection (a) shall apply to eligibility of juveniles who become inmates of public institutions on or after the date that is 1 year after the date of the enactment of this Act.

(2)

Rule for changes requiring state legislation

In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendments made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.

1002.

Health insurance for former foster youth

(a)

Coverage continuity for former foster care children up to age 26

(1)

In general

Section 1902(a)(10)(A)(i)(IX) of the Social Security Act (42 U.S.C. 1396a(a)(10)(A)(i)(IX)) is amended—

(A)

in item (bb), by striking are not described in or enrolled under and inserting are not described in and are not enrolled under;

(B)

in item (cc), by striking responsibility of the State and inserting responsibility of a State; and

(C)

in item (dd), by striking the State plan under this title or under a waiver of the and inserting a State plan under this title or under a waiver of such a.

(2)

Effective date

The amendments made by this subsection shall take effect with respect to foster youth who attain 18 years of age on or after January 1, 2023.

(b)

Guidance

Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to States, with respect to the State Medicaid programs of such States—

(1)

on best practices for—

(A)

removing barriers and ensuring streamlined, timely access to Medicaid coverage for former foster youth up to age 26; and

(B)

conducting outreach and raising awareness among such youth regarding Medicaid coverage options for such youth; and

(2)

which shall include examples of States that have successfully extended Medicaid coverage to former foster youth up to age 26.

1003.

Demonstration project to increase substance use provider capacity under the Medicaid program

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

(aa)

Demonstration project To increase substance use provider capacity

(1)

In general

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

(A)

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

(B)

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

(2)

Purpose

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

(A)

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

(B)

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

(C)

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

(i)

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

(ii)

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

(iii)

are qualified under applicable State law to provide substance use disorder treatment or recovery services.

(D)

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

(i)

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

(ii)

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

(iii)

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

(iv)

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

(3)

Planning grants

(A)

In general

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

(B)

Selection

In selecting States for purposes of this paragraph, the Secretary shall—

(i)

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

(ii)

select States in a manner that ensures geographic diversity; and

(iii)

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

(C)

Activities described

Activities described in this subparagraph are, with respect to a State, each of the following:

(i)

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

(I)

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

(II)

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

(III)

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

(IV)

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

(ii)

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

(D)

Funding

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

(4)

Post-planning States

(A)

In general

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

(B)

Selection

In selecting States for purposes of this paragraph, the Secretary shall—

(i)

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

(ii)

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

(iii)

select States in a manner that ensures geographic diversity; and

(iv)

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

(C)

Applications

(i)

In general

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

(I)

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

(II)

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

(III)

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

(aa)

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

(bb)

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

(cc)

Milestones and timeliness for implementing activities set forth in the plan.

(dd)

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

(IV)

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

(V)

The expected financial impact of the demonstration project under this subsection on the State.

(VI)

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

(VII)

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

(VIII)

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

(ii)

Consultation

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

(5)

Payment

(A)

In general

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

(B)

Qualified sums defined

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

(C)

Non-duplication of payment

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

(6)

Reports

(A)

State reports

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

(i)

The specific activities with respect to which payment under this subsection was provided.

(ii)

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

(iii)

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

(iv)

Other matters as determined by the Secretary.

(B)

CMS reports

(i)

Initial report

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

(I)

the States awarded planning grants under paragraph (3);

(II)

the criteria used in such selection; and

(III)

the activities carried out by such States under such planning grants.

(ii)

Interim report

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

(I)

on activities carried out under the demonstration project under this subsection;

(II)

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

(III)

with a description of the strengths and limitations of such demonstration project; and

(IV)

with a plan for the sustainability of such project.

(iii)

Final report

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

(I)

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

(II)

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

(III)

evaluating such demonstration project.

(C)

AHRQ report

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

(7)

Data sharing and best practices

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

(8)

CMS funding

There is appropriated, out of any funds in the Treasury not otherwise appropriated, $5,000,000 to the Centers for Medicare & Medicaid Services for purposes of implementing this subsection. Such amount shall remain available until expended.

.

1004.

Medicaid drug review and utilization

(a)

Medicaid drug utilization review

(1)

State plan requirement

Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)), as amended by section 1001, is further amended—

(A)

in paragraph (83), at the end, by striking and;

(B)

in paragraph (84), at the end, by striking the period and inserting ; and; and

(C)

by inserting after paragraph (84) the following new paragraph:

(85)

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

.

(2)

Drug review and utilization requirements

Section 1902 of the Social Security Act (42 U.S.C. 1396a), as amended by section 1001, is further amended by adding at the end the following new subsection:

(oo)

Drug review and utilization requirements

(1)

In general

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

(A)

Claims review limitations

(i)

In general

The State has in place—

(I)

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

(II)

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

(III)

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

(aa)

benzodiazepines; or

(bb)

antipsychotics.

(ii)

Managed care entities

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

(iii)

Rules of construction

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

(B)

Program to monitor antipsychotic medications by children

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

(C)

Fraud and abuse identification

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

(D)

Reports

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

(E)

Clarification

Nothing shall prevent a State from satisfying the requirement—

(i)

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

(ii)

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

(iii)

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

(2)

Annual report by Secretary

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

(3)

Exceptions

(A)

Certain individuals exempted

The drug review and utilization requirements under this subsection shall not apply with respect to an individual who—

(i)

is receiving—

(I)

hospice or palliative care; or

(II)

treatment for cancer;

(ii)

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

(iii)

the State elects to treat as exempted from such requirements.

(B)

Exception relating to ensuring access

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

.

(3)

Managed care entities

Section 1932 of the Social Security Act (42 U.S.C. 1396u–2) is amended by adding at the end the following new subsection:

(i)

Drug utilization review activities and requirements

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

.

(b)

Identifying and addressing inappropriate prescribing and billing practices under Medicaid

(1)

In general

Section 1927(g) of the Social Security Act (42 U.S.C. 1396r–8(g)) is amended—

(A)

in paragraph (1)(A)—

(i)

by striking of section 1903(i)(10)(B) and inserting of section 1902(a)(54);

(ii)

by striking , by not later than January 1, 1993,;

(iii)

by inserting after gross overuse, the following: excessive utilization,; and

(iv)

by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization; and

(B)

in paragraph (2)(B)—

(i)

by inserting after gross overuse, the following: excessive utilization,; and

(ii)

by striking or inappropriate or medically unnecessary care and inserting inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization.

(2)

Effective date

The amendments made by paragraph (1) shall take effect with respect to retrospective drug use reviews conducted on or after October 1, 2020.

1005.

Guidance to improve care for infants with neonatal abstinence syndrome and their mothers; GAO study on gaps in Medicaid coverage for pregnant and postpartum women with substance use disorder

(a)

Guidance

Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to improve care for infants with neonatal abstinence syndrome and their families. Such guidance shall include—

(1)

best practices from States with respect to innovative or evidenced-based payment models that focus on prevention, screening, treatment, plans of safe care, and postdischarge services for mothers and fathers with substance use disorders and babies with neonatal abstinence syndrome that improve care and clinical outcomes;

(2)

recommendations for States on available financing options under the Medicaid program under title XIX of such Act and under the Children’s Health Insurance Program under title XXI of such Act for Children’s Health Insurance Program Health Services Initiative funds for parents with substance use disorders, infants with neonatal abstinence syndrome, and home-visiting services;

(3)

guidance and technical assistance to State Medicaid agencies regarding additional flexibilities and incentives related to screening, prevention, and postdischarge services, including parenting supports, and infant-caregiver bonding, including breastfeeding when it is appropriate; and

(4)

guidance regarding suggested terminology and ICD codes to identify infants with neonatal abstinence syndrome and neonatal opioid withdrawal syndrome, which could include opioid-exposure, opioid withdrawal not requiring pharmacotherapy, and opioid withdrawal requiring pharmacotherapy.

(b)

GAO study

Not later than 1 year 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, addressing gaps in coverage for pregnant women with substance use disorder under the Medicaid program under title XIX of the Social Security Act, and gaps in coverage for postpartum women with substance use disorder who had coverage during their pregnancy under the Medicaid program under such title.

1006.

Medicaid health homes for substance-use-disorder Medicaid enrollees

(a)

Extension of enhanced FMAP for certain health homes for individuals with substance use disorders

Section 1945(c) of the Social Security Act (42 U.S.C. 1396w–4(c)) is amended—

(1)

in paragraph (1), by inserting subject to paragraph (4), after except that,; and

(2)

by adding at the end the following new paragraph:

(4)

Special rule relating to substance use disorder health homes

(A)

In general

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

(B)

Report requirements

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

(i)

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

(ii)

The access of such individuals to health care.

(iii)

The total expenditures of such individuals for health care.

For purposes of this subparagraph, the Secretary shall specify all applicable measures for determining quality, access, and expenditures.
(C)

Best practices

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

(D)

Definitions

For purposes of this paragraph:

(i)

SUD-eligible individuals

The term SUD-eligible individual means, with respect to a State, an individual who satisfies all of the following:

(I)

The individual is an eligible individual with chronic conditions.

(II)

The individual is an individual with a substance use disorder.

(III)

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

(ii)

SUD-focused State plan amendment

The term SUD-focused State plan amendment means a State plan amendment under this section that is designed to provide health home services primarily to SUD-eligible individuals.

.

(b)

Requirement for State Medicaid plans To provide coverage for medication-Assisted treatment

(1)

Requirement for State Medicaid plans to provide coverage for medication-assisted treatment

Section 1902(a)(10)(A) of the Social Security Act (42 U.S.C. 1396a(a)(10)(A)) is amended, in the matter preceding clause (i), by striking and (28) and inserting (28), and (29).

(2)

Inclusion of medication-assisted treatment as medical assistance

Section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) is amended—

(A)

in paragraph (28), by striking and at the end;

(B)

by redesignating paragraph (29) as paragraph (30); and

(C)

by inserting after paragraph (28) the following new paragraph:

(29)

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

.

(3)

Medication-assisted treatment defined; Waivers

Section 1905 of the Social Security Act (42 U.S.C. 1396d) is amended by adding at the end the following new subsection:

(ee)

Medication-Assisted treatment

(1)

Definition

For purposes of subsection (a)(29), the term medication-assisted treatment

(A)

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

(B)

includes, with respect to the provision of such drugs and biological products, counseling services and behavioral therapy.

(2)

Exception

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

.

(4)

Effective date

(A)

In general

Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to medical assistance provided on or after October 1, 2020, and before October 1, 2025.

(B)

Exception for State legislation

In the case of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by the amendments made by this subsection, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature.

1007.

Caring recovery for infants and babies

(a)

State plan amendment

Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)), as amended by sections 1001 and 1004, is further amended—

(1)

in paragraph (84)(C), by striking and after the semicolon;

(2)

in paragraph (85), by striking the period at the end and inserting ; and; and

(3)

by inserting after paragraph (85), the following new paragraph:

(86)

provide, at the option of the State, for making medical assistance available on an inpatient or outpatient basis at a residential pediatric recovery center (as defined in subsection (pp)) to infants with neonatal abstinence syndrome.

.

(b)

Residential pediatric recovery center defined

Section 1902 of such Act (42 U.S.C. 1396a), as amended by sections 1001 and 1004, is further amended by adding at the end the following new subsection:

(pp)

Residential pediatric recovery center defined

(1)

In general

For purposes of section 1902(a)(86), the term residential pediatric recovery center means a center or facility that furnishes items and services for which medical assistance is available under the State plan to infants with the diagnosis of neonatal abstinence syndrome without any other significant medical risk factors.

(2)

Counseling and services

A residential pediatric recovery center may offer counseling and other services to mothers (and other appropriate family members and caretakers) of infants receiving treatment at such centers if such services are otherwise covered under the State plan under this title or under a waiver of such plan. Such other services may include the following:

(A)

Counseling or referrals for services.

(B)

Activities to encourage caregiver-infant bonding.

(C)

Training on caring for such infants.

.

(c)

Effective date

The amendments made by this section take effect on the date of enactment of this Act and shall apply to medical assistance furnished on or after that date, without regard to final regulations to carry out such amendments being promulgated as of such date.

1008.

Peer support enhancement and evaluation review

(a)

In general

Not later than 2 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Finance of the Senate, and the Committee on Health, Education, Labor and Pensions of the Senate a report on the provision of peer support services under the Medicaid program.

(b)

Content of report

(1)

In general

The report required under subsection (a) shall include the following information:

(A)

Information on State coverage of peer support services under Medicaid, including—

(i)

the mechanisms through which States may provide such coverage, including through existing statutory authority or through waivers;

(ii)

the populations to which States have provided such coverage;

(iii)

the payment models, including any alternative payment models, used by States to pay providers of such services; and

(iv)

where available, information on Federal and State spending under Medicaid for peer support services.

(B)

Information on selected State experiences in providing medical assistance for peer support services under State Medicaid plans and whether States measure the effects of providing such assistance with respect to—

(i)

improving access to behavioral health services;

(ii)

improving early detection, and preventing worsening, of behavioral health disorders;

(iii)

reducing chronic and comorbid conditions; and

(iv)

reducing overall health costs.

(2)

Recommendations

The report required under subsection (a) shall include recommendations, including recommendations for such legislative and administrative actions related to improving services, including peer support services, and access to peer support services under Medicaid as the Comptroller General of the United States determines appropriate.

1009.

Medicaid substance use disorder treatment via telehealth

(a)

Definitions

In this section:

(1)

Comptroller General

The term Comptroller General means the Comptroller General of the United States.

(2)

School-based health center

The term school-based health center has the meaning given that term in section 2110(c)(9) of the Social Security Act (42 U.S.C. 1397jj(c)(9)).

(3)

Secretary

The term Secretary means the Secretary of Health and Human Services.

(4)

Underserved area

The term underserved area means a health professional shortage area (as defined in section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A))) and a medically underserved area (according to a designation under section 330(b)(3)(A) of the Public Health Service Act (42 U.S.C. 254b(b)(3)(A))).

(b)

Guidance to States regarding Federal reimbursement for furnishing services and treatment for substance use disorders under Medicaid using services delivered via telehealth, including in school-Based health centers

Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue guidance to States on the following:

(1)

State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders, including assessment, medication-assisted treatment, counseling, medication management, and medication adherence with prescribed medication regimes, using services delivered via telehealth. Such guidance shall also include guidance on furnishing services and treatments that address the needs of high-risk individuals, including at least the following groups:

(A)

American Indians and Alaska Natives.

(B)

Adults under the age of 40.

(C)

Individuals with a history of non-fatal overdose.

(D)

Individuals with a co-occurring serious mental illness and substance use disorder.

(2)

State options for Federal reimbursement of expenditures under Medicaid for education directed to providers serving Medicaid beneficiaries with substance use disorders using the hub and spoke model, through contracts with managed care entities, through administrative claiming for disease management activities, and under Delivery System Reform Incentive Payment (DSRIP) programs.

(3)

State options for Federal reimbursement of expenditures under Medicaid for furnishing services and treatment for substance use disorders for individuals enrolled in Medicaid in a school-based health center using services delivered via telehealth.

(c)

GAO evaluation of children's access to services and treatment for substance use disorders under Medicaid

(1)

Study

The Comptroller General shall evaluate children’s access to services and treatment for substance use disorders under Medicaid. The evaluation shall include an analysis of State options for improving children's access to such services and treatment and for improving outcomes, including by increasing the number of Medicaid providers who offer services or treatment for substance use disorders in a school-based health center using services delivered via telehealth, particularly in rural and underserved areas. The evaluation shall include an analysis of Medicaid provider reimbursement rates for services and treatment for substance use disorders.

(2)

Report

Not later than 1 year after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the evaluation conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

(d)

Report on reducing barriers to using services delivered via telehealth and remote patient monitoring for pediatric populations under Medicaid

(1)

In general

Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a report to the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representatives identifying best practices and potential solutions for reducing barriers to using services delivered via telehealth to furnish services and treatment for substance use disorders among pediatric populations under Medicaid. The report shall include—

(A)

analyses of the best practices, barriers, and potential solutions for using services delivered via telehealth to diagnose and provide services and treatment for children with substance use disorders, including opioid use disorder; and

(B)

identification and analysis of the differences, if any, in furnishing services and treatment for children with substance use disorders using services delivered via telehealth and using services delivered in person, such as, and to the extent feasible, with respect to—

(i)

utilization rates;

(ii)

costs;

(iii)

avoidable inpatient admissions and readmissions;

(iv)

quality of care; and

(v)

patient, family, and provider satisfaction.

(2)

Publication

The Secretary shall publish the report required under paragraph (1) on a public internet website of the Department of Health and Human Services.

1010.

Enhancing patient access to non-opioid treatment options

Not later than January 1, 2019, the Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall issue 1 or more final guidance documents, or update existing guidance documents, to States regarding mandatory and optional items and services that may be provided under a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or under a waiver of such a plan, for non-opioid treatment and management of pain, including, but not limited to, evidence-based, non-opioid pharmacological therapies and non-pharmacological therapies.

1011.

Assessing barriers to opioid use disorder treatment

(a)

Study

(1)

In general

The Comptroller General of the United States (in this section referred to as the Comptroller General) shall conduct a study regarding the barriers to providing medication used in the treatment of substance use disorders under Medicaid distribution models such as the buy-and-bill model, and options for State Medicaid programs to remove or reduce such barriers. The study shall include analyses of each of the following models of distribution of substance use disorder treatment medications, particularly buprenorphine, naltrexone, and buprenorphine-naloxone combinations:

(A)

The purchasing, storage, and administration of substance use disorder treatment medications by providers.

(B)

The dispensing of substance use disorder treatment medications by pharmacists.

(C)

The ordering, prescribing, and obtaining substance use disorder treatment medications on demand from specialty pharmacies by providers.

(2)

Requirements

For each model of distribution specified in paragraph (1), the Comptroller General shall evaluate how each model presents barriers or could be used by selected State Medicaid programs to reduce the barriers related to the provision of substance use disorder treatment by examining what is known about the effects of the model of distribution on—

(A)

Medicaid beneficiaries’ access to substance use disorder treatment medications;

(B)

the differential cost to the program between each distribution model for medication-assisted treatment; and

(C)

provider willingness to provide or prescribe substance use disorder treatment medications.

(b)

Report

Not later than 15 months after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.

1012.

Help for moms and babies

(a)

Medicaid State plan

Section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)), as amended by section 1006, is further amended by adding at the end the following new sentence: In the case of a woman who is eligible for medical assistance on the basis of being pregnant (including through the end of the month in which the 60-day period beginning on the last day of her pregnancy ends), who is a patient in an institution for mental diseases for purposes of receiving treatment for a substance use disorder, and who was enrolled for medical assistance under the State plan immediately before becoming a patient in an institution for mental diseases or who becomes eligible to enroll for such medical assistance while such a patient, the exclusion from the definition of medical assistance set forth in the subdivision (B) following paragraph (30) of the first sentence of this subsection shall not be construed as prohibiting Federal financial participation for medical assistance for items or services that are provided to the woman outside of the institution..

(b)

Effective date

(1)

In general

Except as provided in paragraph (2), the amendment made by subsection (a) shall take effect on the date of enactment of this Act.

(2)

Rule for changes requiring state legislation

In the case of a State plan under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendment made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.

1013.

Securing flexibility to treat substance use disorders

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

(7)

Payment shall be made under this title to a State for expenditures for capitation payments described in section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation).

.

1014.

MACPAC study and report on MAT utilization controls under State Medicaid programs

(a)

Study

The Medicaid and CHIP Payment and Access Commission shall conduct a study and analysis of utilization control policies applied to medication-assisted treatment for substance use disorders under State Medicaid programs, including policies and procedures applied both in fee-for-service Medicaid and in risk-based managed care Medicaid, which shall—

(1)

include an inventory of such utilization control policies and related protocols for ensuring access to medically necessary treatment;

(2)

determine whether managed care utilization control policies and procedures for medication-assisted treatment for substance use disorders are consistent with section 438.210(a)(4)(ii) of title 42, Code of Federal Regulations; and

(3)

identify policies that—

(A)

limit an individual's access to medication-assisted treatment for a substance use disorder by limiting the quantity of medication-assisted treatment prescriptions, or the number of refills for such prescriptions, available to the individual as part of a prior authorization process or similar utilization protocols; and

(B)

apply without evaluating individual instances of fraud, waste, or abuse.

(b)

Report

Not later than 1 year after the date of the enactment of this Act, the Medicaid and CHIP Payment and Access Commission shall make publicly available a report containing the results of the study conducted under subsection (a).

1015.

Opioid addiction treatment programs enhancement

(a)

T–MSIS substance use disorder data book

(1)

In general

Not later than the date that is 12 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary) shall publish on the public website of the Centers for Medicare & Medicaid Services a report with comprehensive data on the prevalence of substance use disorders in the Medicaid beneficiary population and services provided for the treatment of substance use disorders under Medicaid.

(2)

Content of report

The report required under paragraph (1) shall include, at a minimum, the following data for each State (including, to the extent available, for the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa):

(A)

The number and percentage of individuals enrolled in the State Medicaid plan or waiver of such plan in each of the major enrollment categories (as defined in a public letter from the Medicaid and CHIP Payment and Access Commission to the Secretary) who have been diagnosed with a substance use disorder and whether such individuals are enrolled under the State Medicaid plan or a waiver of such plan, including the specific waiver authority under which they are enrolled, to the extent available.

(B)

A list of the substance use disorder treatment services by each major type of service, such as counseling, medication-assisted treatment, peer support, residential treatment, and inpatient care, for which beneficiaries in each State received at least 1 service under the State Medicaid plan or a waiver of such plan.

(C)

The number and percentage of individuals with a substance use disorder diagnosis enrolled in the State Medicaid plan or waiver of such plan who received substance use disorder treatment services under such plan or waiver by each major type of service under subparagraph (B) within each major setting type, such as outpatient, inpatient, residential, and other home-based and community-based settings.

(D)

The number of services provided under the State Medicaid plan or waiver of such plan per individual with a substance use disorder diagnosis enrolled in such plan or waiver for each major type of service under subparagraph (B).

(E)

The number and percentage of individuals enrolled in the State Medicaid plan or waiver, by major enrollment category, who received substance use disorder treatment through—

(i)

a medicaid managed care entity (as defined in section 1932(a)(1)(B) of the Social Security Act (42 U.S.C. 1396u–2(a)(1)(B))), including the number of such individuals who received such assistance through a prepaid inpatient health plan or a prepaid ambulatory health plan;

(ii)

a fee-for-service payment model; or

(iii)

an alternative payment model, to the extent available.

(F)

The number and percentage of individuals with a substance use disorder who receive substance use disorder treatment services in an outpatient or home-based and community-based setting after receiving treatment in an inpatient or residential setting, and the number of services received by such individuals in the outpatient or home-based and community-based setting.

(3)

Annual updates

The Secretary shall issue an updated version of the report required under paragraph (1) not later than January 1 of each calendar year through 2024.

(4)

Use of T–MSIS data

The report required under paragraph (1) and updates required under paragraph (3) shall—

(A)

use data and definitions from the Transformed Medicaid Statistical Information System (T–MSIS) data set that is no more than 12 months old on the date that the report or update is published; and

(B)

as appropriate, include a description with respect to each State of the quality and completeness of the data and caveats describing the limitations of the data reported to the Secretary by the State that is sufficient to communicate the appropriate uses for the information.

(b)

Making T–MSIS data on substance use disorders available to researchers

(1)

In general

The Secretary shall publish in the Federal Register a system of records notice for the data specified in paragraph (2) for the Transformed Medicaid Statistical Information System, in accordance with section 552a(e)(4) of title 5, United States Code. The notice shall outline policies that protect the security and privacy of the data that, at a minimum, meet the security and privacy policies of SORN 09–70–0541 for the Medicaid Statistical Information System.

(2)

Required data

The data covered by the systems of records notice required under paragraph (1) shall be sufficient for researchers and States to analyze the prevalence of substance use disorders in the Medicaid beneficiary population and the treatment of substance use disorders under Medicaid across all States (including the District of Columbia, Puerto Rico, the United States Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa), forms of treatment, and treatment settings.

(3)

Initiation of data-sharing activities

Not later than January 1, 2019, the Secretary shall initiate the data-sharing activities outlined in the notice required under paragraph (1).

1016.

Better data sharing to combat the opioid crisis

(a)

In general

Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), as amended by section 1013, is further amended by adding at the end the following new paragraph:

(8)
(A)

The State agency administering the State plan under this title may have reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State to the extent the State agency is permitted to access such databases under State law.

(B)

Such State agency may facilitate reasonable access, as determined by the State, to 1 or more prescription drug monitoring program databases administered or accessed by the State, to same extent that the State agency is permitted under State law to access such databases, for—

(i)

any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and

(ii)

any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3).

(C)

Such State agency may share information in such databases, to the same extent that the State agency is permitted under State law to share information in such databases, with—

(i)

any provider enrolled under the State plan to provide services to Medicaid beneficiaries; and

(ii)

any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under this subsection or under section 1905(t)(3).

.

(b)

Security and privacy

All applicable State and Federal security and privacy protections and laws shall apply to any State agency, individual, or entity accessing 1 or more prescription drug monitoring program databases or obtaining information in such databases in accordance with section 1903(m)(8) of the Social Security Act (as added by subsection (a)).

(c)

Effective date

The amendment made by subsection (a) shall take effect on the date of enactment of this Act.

1017.

Report on innovative State initiatives and strategies to provide housing-related services and supports to individuals struggling with substance use disorders under Medicaid

(a)

In general

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a report to Congress describing innovative State initiatives and strategies for providing housing-related services and supports under a State Medicaid program to individuals with substance use disorders who are experiencing or at risk of experiencing homelessness.

(b)

Content of report

The report required under subsection (a) shall describe the following:

(1)

Existing methods and innovative strategies developed and adopted by State Medicaid programs that have achieved positive outcomes in increasing housing stability among Medicaid beneficiaries with substance use disorders who are experiencing or at risk of experiencing homelessness, including Medicaid beneficiaries with substance use disorders who are—

(A)

receiving treatment for substance use disorders in inpatient, residential, outpatient, or home-based and community-based settings;

(B)

transitioning between substance use disorder treatment settings; or

(C)

living in supportive housing or another model of affordable housing.

(2)

Strategies employed by Medicaid managed care organizations, primary care case managers, hospitals, accountable care organizations, and other care coordination providers to deliver housing-related services and supports and to coordinate services provided under State Medicaid programs across different treatment settings.

(3)

Innovative strategies and lessons learned by States with Medicaid waivers approved under section 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n), including—

(A)

challenges experienced by States in designing, securing, and implementing such waivers or plan amendments;

(B)

how States developed partnerships with other organizations such as behavioral health agencies, State housing agencies, housing providers, health care services agencies and providers, community-based organizations, and health insurance plans to implement waivers or State plan amendments; and

(C)

how and whether States plan to provide Medicaid coverage for housing-related services and supports in the future, including by covering such services and supports under State Medicaid plans or waivers.

(4)

Existing opportunities for States to provide housing-related services and supports through a Medicaid waiver under sections 1115 or 1915 of the Social Security Act (42 U.S.C. 1315, 1396n) or through a State Medicaid plan amendment, such as the Assistance in Community Integration Service pilot program, which promotes supportive housing and other housing-related supports under Medicaid for individuals with substance use disorders and for which Maryland has a waiver approved under such section 1115 to conduct the program.

(5)

Innovative strategies and partnerships developed and implemented by State Medicaid programs or other entities to identify and enroll eligible individuals with substance use disorders who are experiencing or at risk of experiencing homelessness in State Medicaid programs.

1018.

Technical assistance and support for innovative State strategies to provide housing-related supports under Medicaid

(a)

In general

The Secretary of Health and Human Services shall provide technical assistance and support to States regarding the development and expansion of innovative State strategies (including through State Medicaid demonstration projects) to provide housing-related supports and services and care coordination services under Medicaid to individuals with substance use disorders.

(b)

Report

Not later than 180 days after the date of enactment of this Act, the Secretary shall issue a report to Congress detailing a plan of action to carry out the requirements of subsection (a).

II

Medicare Provisions to Address the Opioid Crisis

2001.

Expanding the use of telehealth services for the treatment of opioid use disorder and other substance use disorders

(a)

In general

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

(1)

in paragraph (2)(B)—

(A)

in clause (i), in the matter preceding subclause (I), by striking clause (ii) and inserting clause (ii) and paragraph (6)(C); and

(B)

in clause (ii), in the heading, by striking for home dialysis therapy;

(2)

in paragraph (4)(C)—

(A)

in clause (i), by striking paragraph (6) and inserting paragraphs (5), (6), and (7); and

(B)

in clause (ii)(X), by inserting or telehealth services described in paragraph (7) before the period at the end; and

(3)

by adding at the end the following new paragraph:

(7)

Treatment of substance use disorder services furnished through telehealth

The geographic requirements described in paragraph (4)(C)(i) shall not apply with respect to telehealth services furnished on or after July 1, 2019, to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder, as determined by the Secretary, at an originating site described in paragraph (4)(C)(ii) (other than an originating site described in subclause (IX) of such paragraph).

.

(b)

Implementation

The Secretary of Health and Human Services (in this section referred to as the Secretary) may implement the amendments made by this section by interim final rule.

(c)

Report

(1)

In general

Not later than 5 years after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the impact of the implementation of the amendments made by this section with respect to telehealth services under section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) on—

(A)

the utilization of health care items and services under title XVIII of such Act (42 U.S.C. 1395 et seq.) related to substance use disorders, including emergency department visits; and

(B)

health outcomes related to substance use disorders, such as opioid overdose deaths.

(2)

Funding

For purposes of carrying out paragraph (1), in addition to funds otherwise available, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841, of $3,000,000 to the Centers for Medicare & Medicaid Services Program Management Account to remain available until expended.

2002.

Comprehensive screenings for seniors

(a)

Initial preventive physical examination

Section 1861(ww) of the Social Security Act (42 U.S.C. 1395x(ww)) is amended—

(1)

in paragraph (1)—

(A)

by striking paragraph (2) and and inserting paragraph (2),; and

(B)

by inserting and the furnishing of a review of any current opioid prescriptions (as defined in paragraph (4)), after upon the agreement with the individual,; and

(2)

in paragraph (2)—

(A)

by redesignating subparagraph (N) as subparagraph (O); and

(B)

by inserting after subparagraph (M) the following new subparagraph:

(N)

Screening for potential substance use disorders.

; and

(3)

by adding at the end the following new paragraph:

(4)

For purposes of paragraph (1), the term a review of any current opioid prescriptions means, with respect to an individual determined to have a current prescription for opioids—

(A)

a review of the potential risk factors to the individual for opioid use disorder;

(B)

an evaluation of the individual's severity of pain and current treatment plan;

(C)

the provision of information on non-opioid treatment options; and

(D)

a referral to a specialist, as appropriate.

.

(b)

Annual wellness visit

Section 1861(hhh)(2) of the Social Security Act (42 U.S.C. 1395x(hhh)(2)) is amended—

(1)

by redesignating subparagraph (G) as subparagraph (I); and

(2)

by inserting after subparagraph (F) the following new subparagraphs:

(G)

Screening for potential substance use disorders and referral for treatment as appropriate.

(H)

The furnishing of a review of any current opioid prescriptions (as defined in subsection (ww)(4)).

.

(c)

Rule of construction

Nothing in the amendments made by subsection (a) or (b) shall be construed to prohibit separate payment for structured assessment and intervention services for substance abuse furnished to an individual on the same day as an initial preventive physical examination or an annual wellness visit.

(d)

Effective date

The amendments made by this section shall apply to examinations and visits furnished on or after January 1, 2020.

2003.

Every prescription conveyed securely

(a)

In general

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

(7)

Requirement of e-prescribing for controlled substances

(A)

In general

Subject to subparagraph (B), a prescription for a covered part D drug under a prescription drug plan (or under an MA–PD plan) for a schedule II, III, IV, or V controlled substance shall be transmitted by a health care practitioner electronically in accordance with an electronic prescription drug program that meets the requirements of paragraph (2).

(B)

Exception for certain circumstances

The Secretary shall, through rulemaking, specify circumstances and processes by which the Secretary may waive the requirement under subparagraph (A), with respect to a covered part D drug, including in the case of—

(i)

a prescription issued when the practitioner and dispensing pharmacy are the same entity;

(ii)

a prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard;

(iii)

a prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner;

(iv)

a prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner’s ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual’s medical condition involved;

(v)

a prescription issued by a practitioner prescribing a drug under a research protocol;

(vi)

a prescription issued by a practitioner for a drug for which the Food and Drug Administration requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use;

(vii)

a prescription issued by a practitioner—

(I)

for an individual who receives hospice care under this title; and

(II)

that is not covered under the hospice benefit under this title; and

(viii)

a prescription issued by a practitioner for an individual who is—

(I)

a resident of a nursing facility (as defined in section 1919(a)); and

(II)

dually eligible for benefits under this title and title XIX.

(C)

Dispensing

(i)

Nothing in this paragraph shall be construed as requiring a sponsor of a prescription drug plan under this part, MA organization offering an MA–PD plan under part C, or a pharmacist to verify that a practitioner, with respect to a prescription for a covered part D drug, has a waiver (or is otherwise exempt) under subparagraph (B) from the requirement under subparagraph (A).

(ii)

Nothing in this paragraph shall be construed as affecting the ability of the plan to cover or the pharmacists’ ability to continue to dispense covered part D drugs from otherwise valid written, oral, or fax prescriptions that are consistent with laws and regulations.

(iii)

Nothing in this paragraph shall be construed as affecting the ability of an individual who is being prescribed a covered part D drug to designate a particular pharmacy to dispense the covered part D drug to the extent consistent with the requirements under subsection (b)(1) and under this paragraph.

(D)

Enforcement

The Secretary shall, through rulemaking, have authority to enforce and specify appropriate penalties for non-compliance with the requirement under subparagraph (A).

.

(b)

Effective date

The amendment made by subsection (a) shall apply to coverage of drugs prescribed on or after January 1, 2021.

(c)

Update of Biometric Component of Multifactor Authentication

Not later than 1 year after the date of enactment of this Act, the Attorney General shall update the requirements for the biometric component of multifactor authentication with respect to electronic prescriptions of controlled substances.

2004.

Requiring prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries

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

(1)

in paragraph (1), by inserting after subparagraph (E) the following new subparagraph:

(F)

With respect to plan years beginning on or after January 1, 2022, a drug management program for at-risk beneficiaries described in paragraph (5).

; and

(2)

in paragraph (5)(A), by inserting (and for plan years beginning on or after January 1, 2022, a PDP sponsor shall) after A PDP sponsor may.

2005.

Medicare coverage of certain services furnished by opioid treatment programs

(a)

Coverage

Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended—

(1)

in subparagraph (FF), by striking at the end and;

(2)

in subparagraph (GG), by inserting at the end and; and

(3)

by adding at the end the following new subparagraph:

(HH)

opioid use disorder treatment services (as defined in subsection (jjj)).

.

(b)

Opioid use disorder treatment services and opioid treatment program defined

Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection:

(jjj)

Opioid use disorder treatment services; opioid treatment program

(1)

Opioid use disorder treatment services

The term opioid use disorder treatment services means items and services that are furnished by an opioid treatment program for the treatment of opioid use disorder, including—

(A)

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

(B)

dispensing and administration of such medications, if applicable;

(C)

substance use counseling by a professional to the extent authorized under State law to furnish such services;

(D)

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

(E)

toxicology testing, and

(F)

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

(2)

Opioid treatment program

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

(A)

is enrolled under section 1866(j);

(B)

has in effect a certification by the Substance Abuse and Mental Health Services Administration for such a program;

(C)

is accredited by an accrediting body approved by the Substance Abuse and Mental Health Services Administration; and

(D)

meets such additional conditions as the Secretary may find necessary to ensure—

(i)

the health and safety of individuals being furnished services under such program; and

(ii)

the effective and efficient furnishing of such services.

.

(c)

Payment

(1)

In general

Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended—

(A)

by striking and (BB) and inserting (BB); and

(B)

by inserting before the semicolon at the end the following , and (CC) with respect to opioid use disorder treatment services furnished during an episode of care, the amount paid shall be equal to the amount payable under section 1834(w) less any copayment required as specified by the Secretary.

(2)

Payment determination

Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

(w)

Opioid use disorder treatment services

(1)

In general

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

(2)

Considerations

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

(3)

Annual updates

The Secretary shall provide an update each year to the bundled payment amounts under this subsection.

.

(d)

Including opioid treatment programs as Medicare providers

Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is amended—

(1)

in paragraph (1), by striking at the end and;

(2)

in paragraph (2), by striking the period at the end and inserting ; and; and

(3)

by adding at the end the following new paragraph:

(3)

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

.

2006.

Encouraging appropriate prescribing under Medicare for victims of opioid overdose

Section 1860D–4(c)(5)(C) of the Social Security Act (42 U.S.C. 1395w–104(c)(5)(C)) is amended—

(1)

in clause (i), in the matter preceding subclause (I), by striking For purposes and inserting Except as provided in clause (v), for purposes; and

(2)

by adding at the end the following new clause:

(v)

Treatment of enrollees with a history of opioid-related overdose

(I)

In general

For plan years beginning not later than January 1, 2021, a part D eligible individual who is not an exempted individual described in clause (ii) and who is identified under this clause as a part D eligible individual with a history of opioid-related overdose (as defined by the Secretary) shall be included as a potentially at-risk beneficiary for prescription drug abuse under the drug management program under this paragraph.

(II)

Identification and notice

For purposes of this clause, the Secretary shall—

(aa)

identify part D eligible individuals with a history of opioid-related overdose (as so defined); and

(bb)

notify the PDP sponsor of the prescription drug plan in which such an individual is enrolled of such identification.

.

2007.

Automatic escalation to external review under a Medicare part D drug management program for at-risk beneficiaries

(a)

In general

Section 1860D–4(c)(5) of the Social Security Act (42 U.S.C. 1395ww–10(c)(5)) is amended—

(1)

in subparagraph (B), in each of clauses (ii)(III) and (iii)(IV), by striking and the option of an automatic escalation to external review and inserting , including notice that if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution; and

(2)

in subparagraph (E), by striking and the option and all that follows and inserting the following: and if on reconsideration a PDP sponsor affirms its denial, in whole or in part, the case shall be automatically forwarded to the independent, outside entity contracted with the Secretary for review and resolution..

(b)

Effective date

The amendments made by subsection (a) shall apply beginning not later January 1, 2021.

2008.

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

Section 1862(o)(1) 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 section applies with respect to the Secretary, a provider of services or supplier, and payments to such provider of services or supplier under this title. A PDP sponsor shall notify the Secretary regarding the imposition of any payment suspension pursuant to the previous sentence, such as through the secure internet website portal (or other successor technology) established under section 1859(i).

(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.

III

FDA and Controlled Substance Provisions

A

FDA provisions

1

In general

3001.

Clarifying FDA regulation of non-addictive pain products

(a)

Public meetings

Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary), acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction, which may include—

(1)

the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable;

(2)

the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for the development of non-addictive medical products intended to treat pain or addiction;

(3)

the evidentiary standards and the development of opioid-sparing data for inclusion in the labeling of medical products intended to treat acute or chronic pain; and

(4)

the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive medical products intended to treat pain or addiction.

(b)

Guidance

Not less than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding—

(1)

how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary—

(A)

may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction;

(B)

considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and

(C)

considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition;

(2)

the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence;

(3)

the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain, including—

(A)

alternative data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), including patient registries and patient reported outcomes, as appropriate, to support product labeling;

(B)

ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid-sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit;

(C)

endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use;

(D)

best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and

(E)

the appropriate format in which to submit such data results to the Secretary; and

(4)

the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section.

(c)

Definitions

In this section—

(1)

the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and

(2)

the term opioid-sparing means reducing, replacing, or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain.

3002.

Evidence-based opioid analgesic prescribing guidelines and report

(a)

Guidelines

The Commissioner of Food and Drugs shall develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain only for the relevant therapeutic areas where such guidelines do not exist.

(b)

Public input

In developing the guidelines under subsection (a), the Commissioner of Food and Drugs shall—

(1)

consult with stakeholders, which may include conducting a public meeting of medical professional societies (including any State-based societies), health care providers, State medical boards, medical specialties including pain medicine specialty societies, patient groups, pharmacists, academic or medical research entities, and other entities with experience in health care, as appropriate;

(2)

collaborate with the Director of the Centers for Disease Control and Prevention, as applicable and appropriate, and other Federal agencies with relevant expertise as appropriate; and

(3)

provide for a notice and comment period consistent with section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)) for the submission of comments by the public.

(c)

Report

Not later than 1 year after the date of enactment of this Act, or, if earlier, at the time the guidelines under subsection (a) are finalized, the Commissioner of Food and Drugs shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and post on the public website of the Food and Drug Administration, a report on how the Food and Drug Administration will utilize the guidelines under subsection (a) to protect the public health and a description of the public health need with respect to each such indication-specific treatment guideline.

(d)

Updates

The Commissioner of Food and Drugs shall periodically—

(1)

update the guidelines under subsection (a), informed by public input described in subsection (b); and

(2)

submit to the committees specified in subsection (c) and post on the public website of the Food and Drug Administration an updated report under such subsection.

(e)

Statement To accompany guidelines and recommendations

The Commissioner of Food and Drugs shall ensure that opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations, as applicable—

(1)

are intended to help inform clinical decisionmaking by prescribers and patients; and

(2)

are not intended to be used for the purposes of restricting, limiting, delaying, or denying coverage for, or access to, a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.

2

Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now

3011.

Short title

This chapter may be cited as the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act or the SCREEN Act.

3012.

Notification, nondistribution, and recall of controlled substances

(a)

Prohibited Acts

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

(eee)

The failure to comply with any order issued under section 569D.

.

(b)

Notification, nondistribution, and recall of controlled substances

Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following:

569D.

Notification, nondistribution, and recall of controlled substances

(a)

Order To cease distribution and recall

(1)

In general

If the Secretary determines there is a reasonable probability that a controlled substance would cause serious adverse health consequences or death, the Secretary may, after providing the appropriate person with an opportunity to consult with the agency, issue an order requiring manufacturers, importers, distributors, or pharmacists, who distribute such controlled substance to immediately cease distribution of such controlled substance.

(2)

Hearing

An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify an amendment to the order, and what actions are required by such amended order pursuant to subparagraph (3).

(3)

Order resolution

After an order is issued according to the process under paragraphs (1) and (2), the Secretary shall, except as provided in paragraph (4)—

(A)

vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;

(B)

continue the order ceasing distribution of the controlled substance until a date specified in such order; or

(C)

amend the order to require a recall of the controlled substance, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.

(4)

Risk assessment

If the Secretary determines that the risk of recalling a controlled substance presents a greater health risk than the health risk of not recalling such controlled substance from use, an amended order under subparagraph (B) or (C) of paragraph (3) shall not include either a recall order for, or an order to cease distribution of, such controlled substance, as applicable.

(5)

Action following order

Any person who is subject to an order pursuant to subparagraph (B) or (C) of paragraph (3) shall immediately cease distribution of or recall, as applicable, the controlled substance and provide notification as required by such order.

(b)

Notice to persons affected

If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) to provide either a notice of a recall order for, or an order to cease distribution of, such controlled substance, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substances.

(c)

Nondelegation

An order described in subsection (a)(3) shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research or an official senior to such Director.

(d)

Savings clause

Nothing contained in this section shall be construed as limiting—

(1)

the authority of the Secretary to issue an order to cease distribution of, or to recall, any drug under any other provision of this Act or the Public Health Service Act; or

(2)

the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this Act or the Public Health Service Act.

.

(c)

Controlled substances subject to refusal

The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by inserting , or is a controlled substance subject to an order under section 569D before , or (4).

(d)

Effective date

Sections 301(eee) and 569D of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall be effective beginning on the date of enactment of this Act.

3013.

Single source pattern of imported illegal drugs

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as amended by section 3012, is further amended by adding at the end the following:

(t)

Single source pattern of imported illegal drugs

If the Secretary determines that a person subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or drugs as described in section 306(b)(3)(D), and such pattern is identified by the Secretary as being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order determine all drugs being offered for import from such person as adulterated or misbranded, unless such person can provide evidence otherwise.

.

3014.

Strengthening FDA and CBP coordination and capacity

(a)

In general

The Secretary of Health and Human Services (referred to in this section as the Secretary), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will provide improvements to such facilities, technologies, and inspection capacity. Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection.

(b)

FDA import facilities and inspection capacity

(1)

In general

In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include—

(A)

facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate—

(i)

improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies;

(ii)

improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction;

(iii)

the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods;

(iv)

upgrades to the security of import facilities; and

(v)

innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and

(B)

innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate.

(2)

Innovative technology

Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate and practicable.

(c)

Report

Not later than 6 months after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate on the implementation of this section, including a summary of progress made toward near-real-time information sharing and the interoperability of such technologies.

3

Stop Illicit Drug Importation

3021.

Short title

This chapter may be cited as the Stop Illicit Drug Importation Act of 2018.

3022.

Restricting entrance of illicit drugs

(a)

Food and Drug Administration and U.S. Customs and Border Protection Cooperation

(1)

In general

The Secretary of Health and Human Services (referred to in this section as the Secretary), acting through the Commissioner of Food and Drugs and in consultation with the U.S. Customs and Border Protection, shall develop and periodically update a mutually agreed upon list of the controlled substances that the Secretary will refer to U.S. Customs and Border Protection, unless the Secretary and U.S. Customs and Border Protection agree otherwise, when such substances are offered for import via international mail and appear to violate the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law. The Secretary shall transfer controlled substances on such list to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.).

(2)

Report

Not later than 9 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Secretary of Homeland Security, shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the implementation of this section.

(b)

Debarment, temporary denial of approval, and suspension

(1)

Prohibited act

Section 301(cc) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended—

(A)

by inserting or a drug after food; and

(B)

by inserting from such activity after person debarred.

(2)

Debarment

Section 306(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is amended—

(A)

in paragraph (1)—

(i)

in the matter preceding subparagraph (A), by inserting or (3) after paragraph (2);

(ii)

in subparagraph (A), by striking the comma at the end and inserting a semicolon;

(iii)

in subparagraph (B), by striking , or and inserting a semicolon;

(iv)

in subparagraph (C), by striking the period and inserting ; or; and

(v)

by adding at the end the following:

(D)

a person from importing or offering for import into the United States a drug.

;

(B)

in paragraph (3)—

(i)

in the heading, by inserting or drug after Food;

(ii)

in subparagraph (A), by striking ; or and inserting a semicolon;

(iii)

in subparagraph (B), by striking the period and inserting a semicolon; and

(iv)

by adding at the end the following:

(C)

the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act);

(D)

the person has engaged in a pattern of importing or offering for import—

(i)

controlled substances that are prohibited from importation under section 401(m) of the Tariff Act of 1930 (19 U.S.C. 1401(m)); or

(ii)

adulterated or misbranded drugs that are—

(I)

not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or

(II)

knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary.

; and

(C)

by adding at the end the following:

(5)

Definition

For purposes of paragraph (3)(D), the term pattern of importing or offering for import means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.

.

(c)

Imports and exports

Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended, is further amended—

(1)

by striking , then such article shall be refused admission inserting or (5) such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses (1) through (5) shall be refused admission;

(2)

by inserting If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission. before With respect to an article of food, if importation; and

(3)

by striking Clause (2) of the third sentence and all that follows through the period at the end and inserting the following: Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act..

(d)

Certain illicit articles

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is amended by adding at the end the following—

(u)

Illicit articles containing active pharmaceutical ingredients

(1)

In general

For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article—

(A)

is not—

(i)

accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and

(ii)

designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, a dietary supplement, or other product that is regulated under this Act); and

(B)

is an ingredient that presents significant public health concern and is, or contains—

(i)

an active ingredient in a drug—

(I)

that is approved under section 505 or licensed under section 351 of the Public Health Service Act; or

(II)

for which—

(aa)

an investigational use exemption has been authorized under section 505(i) of this Act or section 351(a) of the Public Health Service Act; and

(bb)

a substantial clinical investigation has been instituted, and such investigation has been made public; or

(ii)

a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i).

(2)

Effect

This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1).

.

4

Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging

3031.

Short title

This chapter may be cited as the Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act.

3032.

Safety-enhancing packaging and disposal features

(a)

Deliberate disposal and packaging elements of strategy

Section 505–1(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(e)) is amended by adding at the end the following:

(4)

Packaging and disposal

The Secretary may require a risk evaluation mitigation strategy for a drug for which there is a serious risk of an adverse drug experience described in subparagraph (B) or (C) of subsection (b)(1), taking into consideration the factors described in subparagraphs (C) and (D) of subsection (f)(2) and in consultation with other relevant Federal agencies with authorities over drug disposal packaging, which may include requiring that—

(A)

the drug be made available for dispensing to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or

(B)

the drug be dispensed to certain patients with a safe disposal packaging or safe disposal system for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) if the Secretary determines that such safe disposal packaging or system may mitigate such serious risk and is sufficiently available.

.

(b)

Assuring access and minimizing burden

Section 505–1(f)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f)(2)(C)) is amended—

(1)

in clause (i) by striking and at the end; and

(2)

by adding at the end the following:

(iii)

patients with functional limitations; and

.

(c)

Application to abbreviated new drug applications

Section 505–1(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(i)) is amended—

(1)

in paragraph (1)—

(A)

by redesignating subparagraph (B) as subparagraph (C); and

(B)

inserting after subparagraph (A) the following:

(B)

A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug.

; and

(2)

in paragraph (2)—

(A)

in subparagraph (A), by striking and at the end;

(B)

by redesignating subparagraph (B) as subparagraph (C); and

(C)

by inserting after subparagraph (A) the following:

(B)

shall permit packaging systems and safe disposal packaging or safe disposal systems that are different from those required for the applicable listed drug under subsection (e)(4); and

.

(d)

GAO report

Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to Congress a report containing—

(1)

a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies;

(2)

an evaluation of existing reference standards with respect to controlled substance disposal products and packaging technologies, including any such standards established by a standards development organization, and how such standards should be considered in ensuring effectiveness of such products and technologies;

(3)

identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act (21 U.S.C. 801 et seq.), are made available to the public and any barriers to the use of such disposal products;

(4)

identification of ways in which packaging technologies are made available to the public and any barriers to the use of such technologies;

(5)

a description of current Federal oversight, if any, of site-of-use, in-home controlled substance disposal products, including—

(A)

identification of the Federal agencies that oversee such products;

(B)

identification of the methods of disposal of controlled substances recommended by such agencies for site-of-use, in-home disposal; and

(C)

a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances;

(6)

a description of current Federal oversight, if any, of controlled substance packaging technologies, including—

(A)

identification of the Federal agencies that oversee such technologies;

(B)

identification of the technologies recommended by such agencies, including unit dose packaging, packaging that provides a set duration, and other packaging systems that may mitigate abuse or misuse; and

(C)

a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and

(7)

recommendations, as appropriate, on—

(A)

whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agency or agencies should be responsible for such oversight and, as applicable, review of such products or technologies; and

(B)

whether there are applicable standards that should be considered to ensure the effectiveness of such products.

5

Postapproval study requirements

3041.

Clarifying FDA postmarket authorities

(a)

Definition of adverse drug experience

Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(b)(1)(E)) is amended by striking of the drug and inserting of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling.

(b)

Safety labeling changes

Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) is amended—

(1)

in subparagraph (A) by—

(A)

striking Safety information and inserting Safety or new effectiveness information; and

(B)

by striking If the Secretary becomes and all that follows through in the labeling of the drug and inserting If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug;

(2)

in clause (i) of subparagraph (B), by inserting before the semicolon , or new effectiveness information;

(3)

in subparagraph (C) by striking safety information and inserting safety or new effectiveness information; and

(4)

in subparagraph (E) by striking safety information and inserting safety or new effectiveness information.

(c)

Guidance

Not less than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance regarding the circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. Such guidance shall also address how the Food and Drug Administration may apply this section and the amendments made thereby with respect to circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials and safety labeling changes related to the use of controlled substances for acute or chronic pain.

B

Controlled substance provisions

1

More flexibility with respect to medication-Assisted treatment for opioid use disorders

3201.

Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders

(a)

Conforming applicable number

Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to read as follows:

(II)

The applicable number is—

(aa)

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

(bb)

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

(cc)

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

(dd)

275 if the practitioner meets the requirements specified in sections 8.610 through 8.655 of title 42, Code of Federal Regulations (or successor regulations).

.

(b)

Eliminating any time limitation for nurse practitioners and physician assistants To become qualifying practitioners

Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)) is amended—

(1)

in subclause (I), by striking or at the end; and

(2)

by amending subclause (II) to read as follows:

(II)

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

.

(c)

Imposing a time limitation for clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwifes To become qualifying practitioners

Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)), as amended by subsection (b), is further amended by adding at the end the following:

(III)

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

.

(d)

Definition of qualifying other practitioner

Section 303(g)(2)(G)(iv) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iv)) is amended by striking nurse practitioner or physician assistant each place it appears and inserting nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant.

(e)

Report by Secretary

Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration, shall submit to Congress a report that assesses the care provided by qualifying practitioners (as defined in section 303(g)(2)(G)(iii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iii))) who are treating, in the case of physicians, more than 100 patients, and in the case of qualifying practitioners who are not physicians, more than 30 patients. Such report shall include recommendations on future applicable patient number levels and limits. In preparing such report, the Secretary shall study, with respect to opioid use disorder treatment—

(1)

the average frequency with which qualifying practitioners see their patients;

(2)

the average frequency with which patients receive counseling, including the rates by which such counseling is provided by such a qualifying practitioner directly, or by referral;

(3)

the frequency of toxicology testing, including the average frequency with which random toxicology testing is administered;

(4)

the average monthly patient caseload for each type of qualifying practitioner;

(5)

the treatment retention rates for patients;

(6)

overdose and mortality rates; and

(7)

any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner.

3202.

Medication-assisted treatment for recovery from substance use disorder

(a)

Waivers for Maintenance Treatment or Detoxification

Section 303(g)(2)(G)(ii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(ii)) is amended by adding at the end the following:

(VIII)

The physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits to the Secretary a written notification under subparagraph (B) and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that—

(aa)

included not less than 8 hours of training on treating and managing opioid-dependent patients; and

(bb)

included, at a minimum—

(AA)

the training described in items (aa) through (gg) of subclause (IV); and

(BB)

training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives.

.

(b)

Treatment for children

The Secretary of Health and Human Services shall consider ways to ensure that an adequate number of qualified practitioners, as defined in subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)), who have a specialty in pediatrics or the treatment of children or adolescents, are granted a waiver under such section 303(g)(2) to treat children and adolescents with substance use disorders.

(c)

Technical Amendment

Section 102(24) of the Controlled Substances Act (21 U.S.C. 802(24)) is amended by striking Health, Education, and Welfare and inserting Health and Human Services.

3203.

Grants to enhance access to substance use disorder treatment

(a)

In general

The Secretary of Health and Human Services shall establish a grant program under which the Secretary may make grants to accredited schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the requirements under subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act, as added by section 3202(a) of this Act.

(b)

Authorization of appropriations

There is authorized to be appropriated, for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023.

3204.

Delivery of a controlled substance by a pharmacy to be administered by injection or implantation

(a)

In general

The Controlled Substances Act is amended by inserting after section 309 (21 U.S.C. 829) the following:

309A.

Delivery of a controlled substance by a pharmacy to an administering practitioner

(a)

In general

Notwithstanding section 102(10), a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this title and the regulations issued by the Attorney General under this title, for the purpose of administering the controlled substance by the practitioner if—

(1)

the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this title;

(2)

the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 303(g)(2) and—

(A)

the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and

(B)

the controlled substance is to be administered by injection or implantation;

(3)

the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place;

(4)

the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;

(5)

except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 14 days after the date of receipt of the controlled substance by the practitioner; and

(6)

notwithstanding any exceptions under section 307, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances were delivered and such other information as may be required by regulations of the Attorney General.

(b)

Modification of number of days before which controlled substance shall be administered

(1)

Initial 2-year period

During the 2-year period beginning on the date of enactment of this section, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (a)(5) if the Attorney General determines that such reduction will—

(A)

reduce the risk of diversion; or

(B)

protect the public health.

(2)

Modifications after submission of report

After the date on which the report described in section 3204(b) of the SUPPORT for Patients and Communities Act is submitted, the Attorney General, in coordination with the Secretary, may modify the number of days described in subsection (a)(5).

(3)

Minimum number of days

Any modification under this subsection shall be for a period of not less than 7 days.

.

(b)

Study and report

Not later than 2 years after the date of enactment of this section, the Comptroller General of the United States shall conduct a study and submit to Congress a report on access to and potential diversion of controlled substances administered by injection or implantation.

(c)

Technical and conforming amendment

The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting after the item relating to section 309 the following:

Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner.

.

2

Empowering Pharmacists in the Fight Against Opioid Abuse

3211.

Short title

This chapter may be cited as the Empowering Pharmacists in the Fight Against Opioid Abuse Act.

3212.

Programs and materials for training on certain circumstances under which a pharmacist may decline to fill a prescription

(a)

In general

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate, as appropriate, materials for pharmacists, health care providers, and patients on—

(1)

circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act (21 U.S.C. 829) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and

(2)

other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances.

(b)

Materials included

In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for—

(1)

pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and

(2)

other health care practitioners and the public on a pharmacist’s ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)).

(c)

Stakeholder input

In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, including individuals with chronic pain.

3

Safe Disposal of Unused Medication

3221.

Short title

This chapter may be cited as the Safe Disposal of Unused Medication Act.

3222.

Disposal of controlled substances of a hospice patient by employees of a qualified hospice program

(a)

In general

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

(5)
(A)

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

(i)

the disposal occurs after the death of a person receiving hospice care;

(ii)

the controlled substance is expired; or

(iii)
(I)

the employee is—

(aa)

the physician of the person receiving hospice care; and

(bb)

registered under section 303(f); and

(II)

the hospice patient no longer requires the controlled substance because the plan of care of the hospice patient has been modified.

(B)

For the purposes of this paragraph:

(i)

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

(ii)

The term employee of a qualified hospice program means a physician, physician assistant, nurse, or other person who—

(I)

is employed by, or pursuant to arrangements made by, a qualified hospice program;

(II)
(aa)

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

(bb)

is acting within the scope of such employment in accordance with applicable State law; and

(III)

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

(iii)

The term qualified hospice program means a hospice program that—

(I)

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

(II)

at the time when the controlled substances are first ordered—

(aa)

provides a copy of the written policies and procedures to the patient or patient representative and family;

(bb)

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

(cc)

documents in the patient’s clinical record that the written policies and procedures were provided and discussed; and

(III)

at the time following the disposal of the controlled substances—

(aa)

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

(bb)

the time, date, and manner in which that disposal occurred.

.

(b)

Guidance

The Attorney General may issue guidance to hospice programs (as defined in paragraph (5) of section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)), as added by subsection (a)) to assist the programs in satisfying the requirements under such paragraph (5).

(c)

Rule of construction relating to State and local law

Nothing in this section or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs.

3223.

GAO study and report on hospice safe drug management

(a)

Study

(1)

In general

The Comptroller General of the United States (in this section referred to as the Comptroller General) shall conduct a study on the requirements applicable to, and challenges of, hospice programs with regard to the management and disposal of controlled substances in the home of an individual.

(2)

Contents

In conducting the study under paragraph (1), the Comptroller General shall include—

(A)

an overview of any challenges encountered by selected hospice programs regarding the disposal of controlled substances, such as opioids, in a home setting, including any key changes in policies, procedures, or best practices for the disposal of controlled substances over time; and

(B)

a description of Federal requirements, including requirements under the Medicare program, for hospice programs regarding the disposal of controlled substances in a home setting, and oversight of compliance with those requirements.

(b)

Report

Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations, if any, for such legislation and administrative action as the Comptroller General determines appropriate.

4

Special Registration for Telemedicine Clarification

3231.

Short title

This chapter may be cited as the Special Registration for Telemedicine Clarification Act of 2018.

3232.

Regulations relating to a special registration for telemedicine

Section 311(h)(2) of the Controlled Substances Act (21 U.S.C. 831(h)(2)) is amended to read as follows:

(2)

Regulations

Not later than 1 year after the date of enactment of the SUPPORT for Patients and Communities Act, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying—

(A)

the limited circumstances in which a special registration under this subsection may be issued; and

(B)

the procedure for obtaining a special registration under this subsection.

.

5

Synthetic Abuse and Labeling of Toxic Substances

3241.

Controlled substance analogues

Section 203 of the Controlled Substances Act (21 U.S.C. 813) is amended—

(1)

by striking A controlled and inserting (a) In general.—A controlled; and

(2)

by adding at the end the following:

(b)

Determination

In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors:

(1)

The marketing, advertising, and labeling of the substance.

(2)

The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose.

(3)

The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold.

(4)

The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance.

(5)

Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means.

(6)

Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws.

(c)

Limitation

For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption.

.

6

Access to Increased Drug Disposal

3251.

Short title

This chapter may be cited as the Access to Increased Drug Disposal Act of 2018.

3252.

Definitions

In this chapter—

(1)

the term Attorney General means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs;

(2)

the term authorized collector means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation);

(3)

the term covered grant means a grant awarded under section 3003; and

(4)

the term eligible collector means a person who is eligible to be an authorized collector.

3253.

Authority to make grants

The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors.

3254.

Application

A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum—

(1)

identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant;

(2)

details a plan to increase participation rates of eligible collectors as authorized collectors; and

(3)

describes how the State will select eligible collectors to be served under the grant.

3255.

Use of grant funds

A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors.

3256.

Eligibility for grant

The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General.

3257.

Duration of grants

The Attorney General shall determine the period of years for which a covered grant is made to a State.

3258.

Accountability and oversight

A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that—

(1)

lists the ultimate recipients of the grant amounts;

(2)

describes the activities undertaken by the State using the grant amounts; and

(3)

contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors.

3259.

Duration of program

The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act.

3260.

Authorization of appropriations

There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this chapter.

7

Using Data To Prevent Opioid Diversion

3271.

Short title

This chapter may be cited as the Using Data To Prevent Opioid Diversion Act of 2018.

3272.

Purpose

(a)

In general

The purpose of this chapter is to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates.

(b)

Rule of construction

Nothing in this chapter should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Administration registrant from the responsibility of the manufacturer, distributor, or other registrant to—

(1)

identify, stop, and report suspicious orders; or

(2)

maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (21 U.S.C. 823) or any successor law or associated regulation.

3273.

Amendments

(a)

Records and reports of registrants

Section 307 of the Controlled Substances Act (21 U.S.C. 827) is amended—

(1)

by redesignating subsections (f), (g), and (h) as subsections (g), (h), and (i), respectively;

(2)

by inserting after subsection (e) the following:

(f)
(1)

The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances:

(A)

The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant.

(B)

The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A).

(2)

The information required to be made available under paragraph (1) shall be made available not later than the 30th day of the first month following the quarter to which the information relates.

(3)
(A)

All registered manufacturers and distributors shall be responsible for reviewing the information made available by the Attorney General under this subsection.

(B)

In determining whether to initiate proceedings under this title against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this title or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant.

; and

(3)

by inserting after subsection (i), as so redesignated, the following:

(j)

All of the reports required under this section shall be provided in an electronic format.

.

(b)

Cooperative arrangements

Section 503 of the Controlled Substances Act (21 U.S.C. 873) is amended by striking subsection (c) and inserting the following:

(c)
(1)

The Attorney General shall, once every 6 months, prepare and make available to regulatory, licensing, attorneys general, and law enforcement agencies of States a standardized report containing descriptive and analytic information on the actual distribution patterns, as gathered through the Automated Reports and Consolidated Orders System, or any subsequent automated system, pursuant to section 307 and which includes detailed amounts, outliers, and trends of distributor and pharmacy registrants, in such States for the controlled substances contained in schedule II, which, in the discretion of the Attorney General, are determined to have the highest abuse.

(2)

If the Attorney General publishes the report described in paragraph (1) once every 6 months as required under paragraph (1), nothing in this subsection shall be construed to bring an action in any court to challenge the sufficiency of the information or to compel the Attorney General to produce any documents or reports referred to in this subsection.

.

(c)

Civil and criminal penalties

Section 402 of the Controlled Substances Act (21 U.S.C. 842) is amended—

(1)

in subsection (a)—

(A)

in paragraph (15), by striking or at the end;

(B)

in paragraph (16), by striking the period at the end and inserting ; or; and

(C)

by inserting after paragraph (16) the following:

(17)

in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 307(f).

; and

(2)

in subsection (c)—

(A)

in paragraph (1), by striking subparagraph (B) and inserting the following:

(B)
(i)

Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the civil penalty shall not exceed $10,000.

(ii)

In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the penalty shall not exceed $100,000.

; and

(B)

in paragraph (2)—

(i)

in subparagraph (A), by inserting or (D) after subparagraph (B); and

(ii)

by adding at the end the following:

(D)

In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the criminal fine under title 18, United States Code, shall not exceed $500,000.

.

3274.

Report

Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report that provides information about how the Attorney General is using data in the Automation of Reports and Consolidated Orders System to identify and stop suspicious activity, including whether the Attorney General is looking at aggregate orders from individual pharmacies to multiple distributors that in total are suspicious, even if no individual order rises to the level of a suspicious order to a given distributor.

8

Opioid Quota Reform

3281.

Short title

This chapter may be cited as the Opioid Quota Reform Act.

3282.

Strengthening considerations for DEA opioid quotas

(a)

In general

Section 306 of the Controlled Substances Act (21 U.S.C. 826) is amended—

(1)

in subsection (a)—

(A)

by inserting (1) after (a);

(B)

in the second sentence, by striking Production and inserting Except as provided in paragraph (2), production; and

(C)

by adding at the end the following:

(2)

The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the controlled substance.

;

(2)

in subsection (b), in the first sentence, by striking production and inserting manufacturing;

(3)

in subsection (c), by striking October and inserting December; and

(4)

by adding at the end the following:

(i)
(1)
(A)

In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a covered controlled substance), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States.

(B)

In estimating diversion under this paragraph, the Attorney General—

(i)

shall consider information the Attorney General, in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and

(ii)

may take into consideration whatever other sources of information the Attorney General determines reliable.

(C)

After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered.

(2)
(A)

For any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale, and potential diversion, in the United States.

(B)

Not later than 1 year after the date of enactment of this subsection, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance:

(i)

An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance.

(ii)

An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year.

(3)

Not later than 1 year after the date of enactment of this subsection, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will—

(A)

take into consideration changes in the accepted medical use of the covered controlled substances; and

(B)

work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events.

.

(b)

Conforming change

The Law Revision Counsel is directed to amend the heading for subsection (b) of section 826 of title 21, United States Code, by striking production and inserting manufacturing.

9

Preventing Drug Diversion

3291.

Short title

This chapter may be cited as the Preventing Drug Diversion Act of 2018.

3292.

Improvements to prevent drug diversion

(a)

Definition

Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended by adding at the end the following:

(57)

The term suspicious order may include, but is not limited to—

(A)

an order of a controlled substance of unusual size;

(B)

an order of a controlled substance deviating substantially from a normal pattern; and

(C)

orders of controlled substances of unusual frequency.

.

(b)

Suspicious orders

Part C of the Controlled Substances Act (21 U.S.C. 821 et seq.) is amended by adding at the end the following:

312.

Suspicious orders

(a)

Reporting

Each registrant shall—

(1)

design and operate a system to identify suspicious orders for the registrant;

(2)

ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and

(3)

upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business.

(b)

Suspicious order database

(1)

In general

Not later than 1 year after the date of enactment of this section, the Attorney General shall establish a centralized database for collecting reports of suspicious orders.

(2)

Satisfaction of reporting requirements

If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be considered to have complied with the requirement under subsection (a)(3) to notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business.

(c)

Sharing information with the States

(1)

In general

The Attorney General shall prepare and make available information regarding suspicious orders in a State, including information in the database established under subsection (b)(1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of controlled substances for the State, as designated by the Governor or chief executive officer of the State.

(2)

Timing

The Attorney General shall provide information in accordance with paragraph (1) within a reasonable period of time after obtaining the information.

(3)

Coordination

In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law.

.

(c)

Reports to Congress

(1)

Definition

In this subsection, the term suspicious order has the meaning given that term in section 102 of the Controlled Substances Act, as amended by this chapter.

(2)

One-time report

Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report on the reporting of suspicious orders, which shall include—

(A)

a description of the centralized database established under section 312 of the Controlled Substances Act, as added by this section, to collect reports of suspicious orders;

(B)

a description of the system and reports established under section 312 of the Controlled Substances Act, as added by this section, to share information with States;

(C)

information regarding how the Attorney General used reports of suspicious orders before the date of enactment of this Act and after the date of enactment of this Act, including how the Attorney General received the reports and what actions were taken in response to the reports; and

(D)

descriptions of the data analyses conducted on reports of suspicious orders to identify, analyze, and stop suspicious activity.

(3)

Additional reports

Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date that is 5 years after the date of enactment of this Act, the Attorney General shall submit to Congress a report providing, for the previous year—

(A)

the number of reports of suspicious orders;

(B)

a summary of actions taken in response to reports, in the aggregate, of suspicious orders; and

(C)

a description of the information shared with States based on reports of suspicious orders.

(4)

One-time GAO report

Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States, in consultation with the Administrator of the Drug Enforcement Administration, shall submit to Congress a report on the reporting of suspicious orders, which shall include an evaluation of the utility of real-time reporting of potential suspicious orders of opioids on a national level using computerized algorithms, including the extent to which such algorithms—

(A)

would help ensure that potentially suspicious orders are more accurately captured, identified, and reported in real time to suppliers before orders are filled;

(B)

may produce false positives of suspicious order reports that could result in market disruptions for legitimate orders of opioids; and

(C)

would reduce the overall length of an investigation that prevents the diversion of suspicious orders of opioids.

IV

Offsets

4001.

Promoting value in Medicaid managed care

Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)), as amended by sections 1013 and 1016, is further amended by adding at the end the following new paragraph:

(9)
(A)

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

(B)

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

(i)

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

(I)

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

(II)

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

(ii)

recovered all or a portion of the expenditures as a result of the entity’s failure to meet such ratio.

(C)

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

(D)

For purposes of this paragraph:

(i)

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

(ii)

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

(iii)

The term other specified entity means—

(I)

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

(II)

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

.

4002.

Requiring reporting by group health plans of prescription drug coverage information for purposes of identifying primary payer situations under the Medicare program

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

(i)

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

(I)

a primary plan to the program under this title; or

(II)

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

.

4003.

Additional religious exemption from health coverage responsibility requirement

(a)

In general

Section 5000A(d)(2)(A) of the Internal Revenue Code of 1986 is amended to read as follows:

(A)

Religious conscience exemptions

(i)

In general

Such term shall not include any individual for any month if such individual has in effect an exemption under section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act which certifies that—

(I)

such individual is a member of a recognized religious sect or division thereof which is described in section 1402(g)(1), and is adherent of established tenets or teachings of such sect or division as described in such section; or

(II)

such individual is a member of a religious sect or division thereof which is not described in section 1402(g)(1), who relies solely on a religious method of healing, and for whom the acceptance of medical health services would be inconsistent with the religious beliefs of the individual.

(ii)

Special rules

(I)

Medical health services defined

For purposes of this subparagraph, the term medical health services does not include routine dental, vision and hearing services, midwifery services, vaccinations, necessary medical services provided to children, services required by law or by a third party, and such other services as the Secretary of Health and Human Services may provide in implementing section 1311(d)(4)(H) of the Patient Protection and Affordable Care Act.

(II)

Attestation required

Clause (i)(II) shall apply to an individual for months in a taxable year only if the information provided by the individual under section 1411(b)(5)(A) of such Act includes an attestation that the individual has not received medical health services during the preceding taxable year.

.

(b)

Effective date

The amendment made by subsection (a) shall apply to taxable years beginning after December 31, 2018.

(c)

Construction

Nothing in the amendment made by subsection (a) shall preempt any State law requiring the provision of medical treatment for children, especially those who are seriously ill.

4004.

Modernizing the reporting of biological and biosimilar products

Subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173) is amended—

(1)

in section 1111, as amended by section 3(1) of the Patient Right to Know Drug Prices Act—

(A)

in the paragraph (3) inserted by such section 3(1), by striking an application and inserting a biosimilar biological product application;

(B)

in the paragraph (4) inserted by such section 3(1), by inserting application before under section 351(k) of the Public Health Service Act;

(C)

in the paragraph (5) inserted by such section 3(1), by striking for licensure of a biological product under section 351(k) of the Public Health Service Act and inserting under section 351(k) of the Public Health Service Act for licensure of a biological product as biosimilar to, or interchangeable with, a reference product;

(D)

in paragraph (7), as redesignated and amended by such section 3(1), by striking or under section 351(a) of the Public Health Service Act and inserting or the owner, or exclusive licensee, of a patent included in a list provided under section 351(l)(3) of the Public Health Service Act; and

(E)

in the paragraph (12) added by such section 3(1), by striking means a brand name drug for which a license is in effect under section 351(a) and inserting has the meaning given such term in section 351(i); and

(2)

in section 1112, as amended by section 3(2) of the Patient Right to Know Drug Prices Act—

(A)

in subsection (a)—

(i)

in paragraph (1), by striking for which a statement under section 351(l)(3)(B)(ii)(I) of the Public Health Service Act has been provided;

(ii)

in paragraph (2)—

(I)

in subparagraph (C)(i), by striking brand name and inserting listed; and

(II)

by amending clause (ii) of subparagraph (C) to read as follows:

(ii)

any of the time periods referred to in section 351(k)(6) of the Public Health Service Act as such period applies to such biosimilar biological product application or to any other biosimilar biological product application based on the same reference product.

;

(B)

in subsection (b)—

(i)

in the subsection heading, by inserting or Biosimilar Biological Product Applicant after Applicant;

(ii)

in paragraph (1)(B), by striking the first sentence and inserting the following: A biosimilar biological product applicant that has submitted a biosimilar biological product application that references a reference product and another biosimilar biological product applicant that has submitted a biosimilar biological product application that references the same reference product shall each file the agreement in accordance with subsection (c).; and

(iii)

in paragraph (2)—

(I)

by striking 2 generic drug applicants and inserting 2 or more generic drug applicants; and

(II)

by striking or an agreement between 2 biosimilar biological product applicants regarding the 1-year period referred to in section 351(k)(6)(A) of the Public Health Service Act as it applies to the biosimilar biological product applications with which the agreement is concerned and inserting , an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product; and

(C)

in subsection (c)(2), by inserting were entered into within 30 days of, after condition for,.

V

Other Medicaid Provisions

A

Mandatory reporting with respect to adult behavioral health measures

5001.

Mandatory reporting with respect to adult behavioral health measures

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

(1)

in subsection (b)—

(A)

in paragraph (3)—

(i)

by striking Not later than January 1, 2013 and inserting the following:

(A)

Voluntary reporting

Not later than January 1, 2013

; and

(ii)

by adding at the end the following:

(B)

Mandatory reporting with respect to behavioral health measures

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

; and

(B)

in paragraph (5), by adding at the end the following new subparagraph:

(C)

Behavioral health measures

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

; and

(2)

in subsection (d)(1)(A)—

(A)

by striking the such plan and inserting such plan; and

(B)

by striking subsection (a)(5) and inserting subsection (b)(5) and, beginning with the report for 2024, all behavioral health measures included in the core set of adult health quality measures maintained under such subsection (b)(5) and any updates or changes to such measures (as required under subsection (b)(3)).

B

Medicaid IMD Additional Info

5011.

Short title

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

5012.

MACPAC exploratory study and report on institutions for mental diseases requirements and practices under Medicaid

(a)

In general

Not later than January 1, 2020, the Medicaid and CHIP Payment and Access Commission established under section 1900 of the Social Security Act (42 U.S.C. 1396) shall conduct an exploratory study, using data from a representative sample of States, and submit to Congress a report on at least the following information, with respect to services furnished to individuals enrolled under State plans under the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.) (or waivers of such plans) who are patients in institutions for mental diseases and for which payment is made through fee-for-service or managed care arrangements under such State plans (or waivers):

(1)

A description of such institutions for mental diseases in each such State, including at a minimum—

(A)

the number of such institutions in the State;

(B)

the facility type of such institutions in the State; and

(C)

any coverage limitations under each such State plan (or waiver) on scope, duration, or frequency of such services.

(2)

With respect to each such institution for mental diseases in each such State, a description of—

(A)

such services provided at such institution;

(B)

the process, including any timeframe, used by such institution to clinically assess and reassess such individuals; and

(C)

the discharge process used by such institution, including any care continuum of relevant services or facilities provided or used in such process.

(3)

A description of—

(A)

any Federal waiver that each such State has for such institutions and the Federal statutory authority for such waiver; and

(B)

any other Medicaid funding sources used by each such State for funding such institutions, such as supplemental payments.

(4)

A summary of State requirements (such as certification, licensure, and accreditation) applied by each such State to such institutions in order for such institutions to receive payment under the State plan (or waiver) and how each such State determines if such requirements have been met.

(5)

A summary of State standards (such as quality standards, clinical standards, and facility standards) that such institutions must meet to receive payment under such State plans (or waivers) and how each such State determines if such standards have been met.

(6)

If determined appropriate by the Commission, recommendations for policies and actions by Congress and the Centers for Medicare & Medicaid Services, such as on how State Medicaid programs may improve care and improve standards and including a recommendation for how the Centers for Medicare & Medicaid Services can improve data collection from such programs to address any gaps in information.

(b)

Stakeholder input

In carrying out subsection (a), the Medicaid and CHIP Payment and Access Commission shall seek input from State Medicaid directors and stakeholders, including at a minimum the Substance Abuse and Mental Health Services Administration, Centers for Medicare & Medicaid Services, State Medicaid officials, State mental health authorities, Medicaid beneficiary advocates, health care providers, and Medicaid managed care organizations.

(c)

Definitions

In this section:

(1)

Representative sample of States

The term representative sample of States means a non-probability sample in which at least two States are selected based on the knowledge and professional judgment of the selector.

(2)

State

The term State means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States.

(3)

Institution for mental diseases

The term institution for mental diseases has the meaning given such term in section 435.1010 of title 42, Code of Federal Regulations, or any successor regulation.

C

CHIP Mental Health and Substance Use Disorder Parity

5021.

Short title

This subtitle may be cited as the CHIP Mental Health and Substance Use Disorder Parity Act.

5022.

Ensuring access to mental health and substance use disorder services for children and pregnant women under the Children’s Health Insurance Program

(a)

In general

Section 2103(c)(1) of the Social Security Act (42 U.S.C. 1397cc(c)(1)) is amended by adding at the end the following new subparagraph:

(E)

Mental health and substance use disorder services (as defined in paragraph (5)).

.

(b)

Mental health and substance use disorder services

(1)

In general

Section 2103(c) of the Social Security Act (42 U.S.C. 1397cc(c)) is amended—

(A)

by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (6), (7), (8), and (9), respectively; and

(B)

by inserting after paragraph (4) the following new paragraph:

(5)

Mental health and substance use disorder services

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

(A)

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

(B)

be delivered in a culturally and linguistically appropriate manner.

.

(2)

Conforming amendments

(A)

Section 2103(a) of the Social Security Act (42 U.S.C. 1397cc(a)) is amended, in the matter before paragraph (1), by striking paragraphs (5), (6), and (7) and inserting paragraphs (5), (6), (7), and (8).

(B)

Section 2110(a) of the Social Security Act (42 U.S.C. 1397jj(a)) is amended—

(i)

in paragraph (18), by striking substance abuse each place it appears and inserting substance use; and

(ii)

in paragraph (19), by striking substance abuse and inserting substance use.

(C)

Section 2110(b)(5)(A)(i) of the Social Security Act (42 U.S.C. 1397jj(b)(5)(A)(i)) is amended by striking subsection (c)(5) and inserting subsection (c)(6).

(c)

Assuring access to care

Section 2102(a)(7)(B) of the Social Security Act (42 U.S.C. 1397bb(c)(2)) is amended by striking section 2103(c)(5) and inserting paragraphs (5) and (6) of section 2103(c).

(d)

Mental health services parity

Subparagraph (A) of paragraph (7) of section 2103(c) of the Social Security Act (42 U.S.C. 1397cc(c)) (as redesignated by subsection (b)(1)) is amended to read as follows:

(A)

In general

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

.

(e)

Effective date

(1)

In general

Subject to paragraph (2), the amendments made by this section shall take effect with respect to child health assistance provided on or after the date that is 1 year after the date of the enactment of this Act.

(2)

Exception for State legislation

In the case of a State child health plan under title XXI of the Social Security Act (or a waiver of such plan), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan (or waiver) to meet any requirement imposed by the amendments made by this section, the respective plan (or waiver) shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of enactment of this section. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature.

D

Medicaid Reentry

5031.

Short title

This subtitle may be cited as the Medicaid Reentry Act.

5032.

Promoting State innovations to ease transitions integration to the community for certain individuals

(a)

Stakeholder group development of best practices; State Medicaid program innovation

(1)

Stakeholder group best practices

Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a stakeholder group of representatives of managed care organizations, Medicaid beneficiaries, health care providers, the National Association of Medicaid Directors, and other relevant representatives from local, State, and Federal jail and prison systems to develop best practices (and submit to the Secretary and Congress a report on such best practices) for States—

(A)

to ease the health care-related transition of an individual who is an inmate of a public institution from the public institution to the community, including best practices for ensuring continuity of health insurance coverage or coverage under the State Medicaid plan under title XIX of the Social Security Act, as applicable, and relevant social services; and

(B)

to carry out, with respect to such an individual, such health care-related transition not later than 30 days after such individual is released from the public institution.

(2)

State Medicaid program innovation

The Secretary of Health and Human Services shall work with States on innovative strategies to help individuals who are inmates of public institutions and otherwise eligible for medical assistance under the Medicaid program under title XIX of the Social Security Act transition, with respect to enrollment for medical assistance under such program, seamlessly to the community.

(b)

Guidance on innovative service delivery systems demonstration project opportunities

Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Administrator of the Centers for Medicare & Medicaid Services, shall issue a State Medicaid Director letter, based on best practices developed under subsection (a)(1), regarding opportunities to design demonstration projects under section 1115 of the Social Security Act (42 U.S.C. 1315) to improve care transitions for certain individuals who are soon-to-be former inmates of a public institution and who are otherwise eligible to receive medical assistance under title XIX of such Act, including systems for, with respect to a period (not to exceed 30 days) immediately prior to the day on which such individuals are expected to be released from such institution—

(1)

providing assistance and education for enrollment under a State plan under the Medicaid program under title XIX of such Act for such individuals during such period; and

(2)

providing health care services for such individuals during such period.

(c)

Rule of construction

Nothing under title XIX of the Social Security Act or any other provision of law precludes a State from reclassifying or suspending (rather than terminating) eligibility of an individual for medical assistance under title XIX of the Social Security Act while such individual is an inmate of a public institution.

E

Medicaid Partnership

5041.

Short title

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

5042.

Medicaid providers are required to note experiences in record systems to help in-need patients

(a)

Requirements under the Medicaid program relating to qualified prescription drug monitoring programs and prescribing certain controlled substances

Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is amended by inserting after section 1943 the following new section:

1944.

Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances

(a)

In general

Subject to subsection (d), beginning October 1, 2021, a State—

(1)

shall require each covered provider to check, in accordance with such timing, manner, and form as specified by the State, the prescription drug history of a covered individual being treated by the covered provider through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance; and

(2)

in the case that such a provider is not able to conduct such a check despite a good faith effort by such provider—

(A)

shall require the provider to document such good faith effort, including the reasons why the provider was not able to conduct the check; and

(B)

may require the provider to submit, upon request, such documentation to the State.

(b)

Qualified prescription drug monitoring program described

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

(1)

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

(A)

Information regarding the prescription drug history of a covered individual with respect to controlled substances.

(B)

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

(C)

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

(2)

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

A qualified prescription drug monitoring program described in this subsection, with respect to a State, may have in place, in accordance with applicable State and Federal law, a data-sharing agreement with the State Medicaid program that allows the medical director and pharmacy director of such program (and any designee of such a director who reports directly to such director) to access the information described in paragraph (1) in an electronic format. The State Medicaid program under this title may facilitate reasonable and limited access, as determined by the State and ensuring documented beneficiary protections regarding the use of such data, to such qualified prescription drug monitoring program for the medical director or pharmacy director of any managed care entity (as defined under section 1932(a)(1)(B)) that has a contract with the State under section 1903(m) or under section 1905(t)(3), or the medical director or pharmacy director of any entity that has a contract to manage the pharmaceutical benefit with respect to individuals enrolled in the State plan (or under a waiver of the State plan). All applicable State and Federal security and privacy laws shall apply to the directors or designees of such directors of any State Medicaid program or entity accessing a qualified prescription drug monitoring program under this section.
(c)

Application of privacy rules clarification

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

(d)

Ensuring access

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

(e)

Reports

(1)

State reports

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

(A)

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

(B)

Aggregate trends with respect to prescribing controlled substances such as—

(i)

the quantity of daily morphine milligram equivalents prescribed for controlled substances;

(ii)

the number and quantity of daily morphine milligram equivalents prescribed for controlled substances per covered individual; and

(iii)

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

(C)

Whether or not the State requires (and a detailed explanation as to why the State does or does not require) pharmacists to check the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before dispensing a controlled substance to such individual.

(D)

An accounting of any data or privacy breach of a qualified prescription drug monitoring program described in subsection (b), the number of covered individuals impacted by each such breach, and a description of the steps the State has taken to address each such breach, including, to the extent required by State or Federal law or otherwise determined appropriate by the State, alerting any such impacted individual and law enforcement of the breach.

(2)

Report by CMS

Not later than October 1, 2023, the Administrator of the Centers for Medicare & Medicaid Services shall publish on the publicly available website of the Centers for Medicare & Medicaid Services a report including the following information:

(A)

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

(B)

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

(f)

Increase to FMAP and Federal matching rates for certain expenditures relating to qualified prescription drug monitoring programs

(1)

In general

With respect to a State that meets the condition described in paragraph (2) and any quarter occurring during fiscal year 2019 or fiscal year 2020, the Federal medical assistance percentage or Federal matching rate that would otherwise apply to such State under section 1903(a) for such quarter, with respect to expenditures by the State for activities under the State plan (or a waiver of such plan) to design, develop, or implement a prescription drug monitoring program (and to make connections to such program) that satisfies the criteria described in paragraphs (1) and (2) of subsection (b), shall be equal to 100 percent.

(2)

Condition

The condition described in this paragraph, with respect to a State, is that the State (in this paragraph referred to as the administering State) has in place agreements with all States that are contiguous to such administering State that, when combined, enable covered providers in all such contiguous States to access, through the prescription drug monitoring program, the information that is described in subsection (b)(1) of covered individuals of such administering State and that covered providers in such administering State are able to access through such program.

(g)

Rule of construction

Nothing in this section prevents a State from requiring pharmacists to check the prescription drug history of covered individuals through a qualified prescription drug monitoring program before dispensing controlled substances to such individuals.

(h)

Definitions

In this section:

(1)

Controlled substance

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

(2)

Covered individual

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

(A)

is receiving—

(i)

hospice or palliative care; or

(ii)

treatment for cancer;

(B)

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

(C)

the State elects to treat as exempted from such term.

(3)

Covered provider

(A)

In general

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

(B)

Exceptions

(i)

In general

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

(ii)

Exceptions process

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

.

(b)

Guidance

Not later than October 1, 2019, the Administrator of the Centers for Medicare & Medicaid Services, in consultation with the Director of the Centers for Disease Control and Prevention, shall issue guidance on best practices on the uses of prescription drug monitoring programs required of prescribers and on protecting the privacy of Medicaid beneficiary information maintained in and accessed through prescription drug monitoring programs.

(c)

Development of model State practices

(1)

In general

Not later than October 1, 2020, the Secretary of Health and Human Services shall develop and publish model practices to assist State Medicaid program operations in identifying and implementing strategies to utilize data-sharing agreements described in the matter following paragraph (2) of section 1944(b) of the Social Security Act, as added by subsection (a), for the following purposes:

(A)

Monitoring and preventing fraud, waste, and abuse.

(B)

Improving health care for individuals enrolled in a State plan under title XIX of such Act (or under a waiver of such plan) who—

(i)

transition in and out of coverage under such title;

(ii)

may have sources of health care coverage in addition to coverage under such title; or

(iii)

pay for prescription drugs with cash.

(C)

Any other purposes specified by the Secretary.

(2)

Elements of model practices

The model practices described in paragraph (1)—

(A)

shall include strategies for assisting States in allowing the medical director or pharmacy director (or designees of such a director) of managed care organizations or pharmaceutical benefit managers to access information with respect to all covered individuals served by such managed care organizations or pharmaceutical benefit managers to access as a single data set, in an electronic format; and

(B)

shall include any appropriate beneficiary protections and privacy guidelines.

(3)

Consultation

In developing model practices under this subsection, the Secretary shall consult with the National Association of Medicaid Directors, managed care entities (as defined in section 1932(a)(1)(B) of the Social Security Act) with contracts with States pursuant to section 1903(m) of such Act, pharmaceutical benefit managers, physicians and other health care providers, beneficiary advocates, and individuals with expertise in health care technology related to prescription drug monitoring programs and electronic health records.

(d)

Report by Comptroller General

Not later than October 1, 2020, the Comptroller General of the United States shall issue a report examining the operation of prescription drug monitoring programs administered by States, including data security and access standards used by such programs.

F

IMD CARE Act

5051.

Short title

This title may be cited as the Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act or the IMD CARE Act.

5052.

State option to provide Medicaid coverage for certain individuals with substance use disorders who are patients in certain institutions for mental diseases

(a)

In general

Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), as amended by preceding sections of this Act, is further amended—

(1)

in section 1905(a), in the subdivision (B) that follows paragraph (30), by inserting (except in the case of services provided under a State plan amendment described in section 1915(l)) before the period; and

(2)

in section 1915, by adding at the end the following new subsection:

(l)

State plan amendment option to provide medical assistance for certain individuals who are patients in certain institutions for mental diseases

(1)

In general

With respect to calendar quarters beginning during the period beginning October 1, 2019, and ending September 30, 2023, a State may elect, through a State plan amendment, to provide medical assistance for items and services furnished to an eligible individual who is a patient in an eligible institution for mental diseases in accordance with the requirements of this subsection.

(2)

Payments

Subject to paragraphs (3) and (4), amounts expended under a State plan amendment under paragraph (1) for services described in such paragraph furnished, with respect to a 12-month period, to an eligible individual who is a patient in an eligible institution for mental diseases shall be treated as medical assistance for which payment is made under section 1903(a) but only to the extent that such services are furnished for not more than a period of 30 days (whether or not consecutive) during such 12-month period.

(3)

Maintenance of effort

(A)

In general

As a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall (during the period in which it so furnished such medical assistance through a State plan amendment under this subsection) maintain on an annual basis a level of funding expended by the State (and political subdivisions thereof) other than under this title from non-Federal funds for—

(i)

items and services furnished to eligible individuals who are patients in eligible institutions for mental diseases that is not less than the level of such funding for such items and services for the most recently ended fiscal year as of the date of enactment of this subsection or, if higher, for the most recently ended fiscal year as of the date the State submits a State plan amendment to the Secretary to provide such medical assistance in accordance with this subsection; and

(ii)

items and services (including services described in subparagraph (B)) furnished to eligible individuals in outpatient and community-based settings that is not less than the level of such funding for such items and services for the most recently ended fiscal year as of the date of enactment of this subsection or, if higher, for the most recently ended fiscal year as of the date the State submits a State plan amendment to the Secretary to provide such medical assistance in accordance with this subsection.

(B)

Services described

For purposes of subparagraph (A)(ii), services described in this subparagraph are the following:

(i)

Outpatient and community-based substance use disorder treatment.

(ii)

Evidence-based recovery and support services.

(iii)

Clinically-directed therapeutic treatment to facilitate recovery skills, relapse prevention, and emotional coping strategies.

(iv)

Outpatient medication-assisted treatment, related therapies, and pharmacology.

(v)

Counseling and clinical monitoring.

(vi)

Outpatient withdrawal management and related treatment designed to alleviate acute emotional, behavioral, cognitive, or biomedical distress resulting from, or occurring with, an individual’s use of alcohol and other drugs.

(vii)

Routine monitoring of medication adherence.

(viii)

Other outpatient and community-based services for the treatment of substance use disorders, as designated by the Secretary.

(C)

State reporting requirement

(i)

In general

Prior to approval of a State plan amendment under this subsection, as a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall report to the Secretary, in accordance with the process established by the Secretary under clause (ii), the information deemed necessary by the Secretary under such clause.

(ii)

Process

Not later than the date that is 8 months after the date of enactment of this subsection, the Secretary shall establish a process for States to report to the Secretary, at such time and in such manner as the Secretary deems appropriate, such information as the Secretary deems necessary to verify a State’s compliance with subparagraph (A).

(4)

Ensuring a continuum of services

(A)

In general

As a condition for a State receiving payments under section 1903(a) for medical assistance provided in accordance with this subsection, the State shall carry out each of the requirements described in subparagraphs (B) through (D).

(B)

Notification

Prior to approval of a State plan amendment under this subsection, the State shall notify the Secretary of how the State will ensure that eligible individuals receive appropriate evidence-based clinical screening prior to being furnished with items and services in an eligible institution for mental diseases, including initial and periodic assessments to determine the appropriate level of care, length of stay, and setting for such care for each individual.

(C)

Outpatient services; inpatient and residential services

(i)

Outpatient services

The State shall, at a minimum, provide medical assistance for services that could otherwise be covered under the State plan, consistent with each of the following outpatient levels of care:

(I)

Early intervention for individuals who, for a known reason, are at risk of developing substance-related problems and for individuals for whom there is not yet sufficient information to document a diagnosable substance use disorder.

(II)

Outpatient services for less than 9 hours per week for adults, and for less than 6 hours per week for adolescents, for recovery or motivational enhancement therapies and strategies.

(III)

Intensive outpatient services for 9 hours or more per week for adults, and for 6 hours or more per week for adolescents, to treat multidimensional instability.

(IV)

Partial hospitalization services for 20 hours or more per week for adults and adolescents to treat multidimensional instability that does not require 24-hour care.

(ii)

Inpatient and residential services

The State shall provide medical assistance for services that could otherwise be covered under the State plan, consistent with at least 2 of the following inpatient and residential levels of care:

(I)

Clinically managed, low-intensity residential services that provide adults and adolescents with 24-hour living support and structure with trained personnel and at least 5 hours of clinical service per week per individual.

(II)

Clinically managed, population-specific, high-intensity residential services that provide adults with 24-hour care with trained counselors to stabilize multidimensional imminent danger along with less intense milieu and group treatment for those with cognitive or other impairments unable to use full active milieu or therapeutic community.

(III)

Clinically managed, medium-intensity residential services for adolescents, and clinically managed, high-intensity residential services for adults, that provide 24-hour care with trained counselors to stabilize multidimensional imminent danger and preparation for outpatient treatment.

(IV)

Medically monitored, high-intensity inpatient services for adolescents, and medically monitored, intensive inpatient services withdrawal management for adults, that provide 24-hour nursing care, make physicians available for significant problems in Dimensions 1, 2, or 3, and provide counseling services 16 hours per day.

(V)

Medically managed, intensive inpatient services for adolescents and adults that provide 24-hour nursing care and daily physician care for severe, unstable problems in Dimensions 1, 2 or 3.

(D)

Transition of care

In order to ensure an appropriate transition for an eligible individual from receiving care in an eligible institution for mental diseases to receiving care at a lower level of clinical intensity within the continuum of care (including outpatient services), the State shall ensure that—

(i)

a placement in such eligible institution for mental diseases would allow for an eligible individual’s successful transition to the community, considering such factors as proximity to an individual’s support network (such as family members, employment, and counseling and other services near an individual’s residence); and

(ii)

all eligible institutions for mental diseases that furnish items and services to individuals for which medical assistance is provided under the State plan—

(I)

are able to provide care at such lower level of clinical intensity; or

(II)

have an established relationship with another facility or provider that is able to provide care at such lower level of clinical intensity and accepts patients receiving medical assistance under this title under which the eligible institution for mental diseases may arrange for individuals to receive such care from such other facility or provider.

(5)

Application to managed care

Payments for, and limitations to, medical assistance furnished in accordance with this subsection shall be in addition to and shall not be construed to limit or supersede the ability of States to make monthly capitation payments to managed care organizations for individuals receiving treatment in institutions for mental diseases in accordance with section 438.6(e) of title 42, Code of Federal Regulations (or any successor regulation).

(6)

Other medical assistance

The provision of medical assistance for items and services furnished to an eligible individual who is a patient in an eligible institution for mental diseases in accordance with the requirements of this subsection shall not prohibit Federal financial participation for medical assistance for items or services that are provided to such eligible individual in or away from the eligible institution for mental disease during any period in which the eligible individual is receiving items or services in accordance with this subsection.

(7)

Definitions

In this subsection:

(A)

Dimensions 1, 2, or 3

The term Dimensions 1, 2, or 3 has the meaning given that term for purposes of the publication of the American Society of Addiction Medicine entitled The ASAM Criteria: Treatment Criteria for Addictive Substance-Related, and Co-Occurring Conditions, 2013.

(B)

Eligible individual

The term eligible individual means an individual who—

(i)

with respect to a State, is enrolled for medical assistance under the State plan or a waiver of such plan;

(ii)

is at least 21 years of age;

(iii)

has not attained 65 years of age; and

(iv)

has at least 1 substance use disorder.

(C)

Eligible institution for mental diseases

The term eligible institution for mental diseases means an institution for mental diseases that—

(i)

follows reliable, evidence-based practices; and

(ii)

offers at least 2 forms of medication-assisted treatment for substance use disorders on site, including, in the case of medication-assisted treatment for opioid use disorder, at least 1 antagonist and 1 partial agonist.

(D)

Institution for mental diseases

The term institution for mental diseases has the meaning given that term in section 1905(i).

.

(b)

Rule of construction

Nothing in the amendments made by subsection (a) shall be construed as encouraging a State to place an individual in an inpatient or a residential care setting where a home or community-based care setting would be more appropriate for the individual, or as preventing a State from conducting or pursuing a demonstration project under section 1115 of the Social Security Act to improve access to, and the quality of, substance use disorder treatment for eligible populations.

G

Medicaid Improvement Fund

5061.

Medicaid Improvement Fund

Section 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w–1(b)(1)) is amended by striking $0 and inserting $31,000,000.

VI

Other Medicare Provisions

A

Testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology

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))).

.

B

Abuse Deterrent Access

6011.

Short title

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

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.

C

Medicare Opioid Safety Education

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.

D

Opioid Addiction Action Plan

6031.

Short title

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

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.

E

Advancing High Quality Treatment for Opioid Use Disorders in Medicare

6041.

Short title

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

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:

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.

Such term shall include an individual who is dually eligible for benefits under this title and title XIX if such individual satisfies the criteria described in subparagraphs (A) through (D).
(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.

.

F

Responsible Education Achieves Care and Healthy Outcomes for Users’ Treatment

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.

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.

G

Preventing Addiction for Susceptible Seniors

6061.

Short title

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

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.

.

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).

.

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

are the following:

(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)).

.

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.

.

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.

H

Expanding Oversight of Opioid Prescribing and Payment

6071.

Short title

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

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.

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.

I

Dr. Todd Graham Pain Management, Treatment, and Recovery

6081.

Short title

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

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).

.

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.

.

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.

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.

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.

J

Combating Opioid Abuse for Care in Hospitals

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.

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.

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.

.

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.

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.

K

Providing Reliable Options for Patients and Educational Resources

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.

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.

.

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.

.

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.

.

L

Fighting the Opioid Epidemic With Sunshine

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.

VII

Public Health Provisions

A

Awareness and training

7001.

Report on effects on public health of synthetic drug use

(a)

In general

Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Surgeon General of the Public Health Service, shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the health effects of new psychoactive substances, including synthetic drugs, used by adolescents and young adults.

(b)

New psychoactive substance defined

For purposes of subsection (a), the term new psychoactive substance means a controlled substance analogue (as defined in section 102(32) of the Controlled Substances Act (21 U.S.C. 802(32)).

7002.

First responder training

Section 546 of the Public Health Service Act (42 U.S.C. 290ee–1) is amended—

(1)

in subsection (c)—

(A)

in paragraph (2), by striking and at the end;

(B)

in paragraph (3), by striking the period and inserting ; and; and

(C)

by adding at the end the following:

(4)

train and provide resources for first responders and members of other key community sectors on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs to protect themselves from exposure to such drugs and respond appropriately when exposure occurs.

;

(2)

in subsection (d), by striking and mechanisms for referral to appropriate treatment for an entity receiving a grant under this section and inserting mechanisms for referral to appropriate treatment, and safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs;

(3)

in subsection (f)—

(A)

in paragraph (3), by striking and at the end;

(B)

in paragraph (4), by striking the period and inserting ; and; and

(C)

by adding at the end the following:

(5)

the number of first responders and members of other key community sectors trained on safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs.

;

(4)

by redesignating subsection (g) as subsection (h);

(5)

by inserting after subsection (f) the following:

(g)

Other key community sectors

In this section, the term other key community sectors includes substance use disorder treatment providers, emergency medical services agencies, agencies and organizations working with prison and jail populations and offender reentry programs, health care providers, harm reduction groups, pharmacies, community health centers, tribal health facilities, and mental health providers.

; and

(6)

in subsection (h), as so redesignated, by striking $12,000,000 for each of fiscal years 2017 through 2021 and inserting $36,000,000 for each of fiscal years 2019 through 2023.

B

Pilot program for public health laboratories To detect fentanyl and other synthetic opioids

7011.

Pilot program for public health laboratories to detect fentanyl and other synthetic opioids

(a)

Grants

The Secretary of Health and Human Services (referred to in this section as the Secretary) shall award grants to, or enter into cooperative agreements with, Federal, State, and local agencies to improve coordination between public health laboratories and laboratories operated by law enforcement agencies, such as Customs and Border Protection and the Drug Enforcement Administration, to improve detection of synthetic opioids, including fentanyl and its analogues, as described in subsection (b).

(b)

Detection activities

The Secretary, in consultation with the Director of the National Institute of Standards and Technology, the Director of the Centers for Disease Control and Prevention, the Attorney General of the United States, and the Administrator of the Drug Enforcement Administration, shall, for purposes of this section, develop or identify—

(1)

best practices for safely handling and testing synthetic opioids, including fentanyl and its analogues, including with respect to reference materials, instrument calibration, and quality control protocols;

(2)

reference materials and quality control standards related to synthetic opioids, including fentanyl and its analogues, to enhance—

(A)

clinical diagnostics;

(B)

postmortem data collection; and

(C)

portable testing equipment utilized by law enforcement and public health officials; and

(3)

procedures for the identification of new and emerging synthetic opioid formulations and procedures for reporting those findings to appropriate law enforcement agencies and Federal, State, and local public health laboratories and health departments, as appropriate.

(c)

Laboratories

The Secretary shall require recipients of grants or cooperative agreements under subsection (a) to—

(1)

follow the best practices established under subsection (b) and have the appropriate capabilities to provide laboratory testing of controlled substances, such as synthetic fentanyl, and biospecimens for the purposes of aggregating and reporting public health information to Federal, State, and local public health officials, laboratories, and other entities the Secretary deems appropriate;

(2)

work with law enforcement agencies and public health authorities, as practicable;

(3)

provide early warning information to Federal, State, and local law enforcement agencies and public health authorities regarding trends or other data related to the supply of synthetic opioids, including fentanyl and its analogues;

(4)

provide biosurveillance capabilities with respect to identifying trends in adverse health outcomes associated with non-fatal exposures; and

(5)

provide diagnostic testing, as appropriate and practicable, for non-fatal exposures of emergency personnel, first responders, and other individuals.

(d)

Authorization of appropriations

To carry out this section, there is authorized to be appropriated $15,000,000 for each of fiscal years 2019 through 2023.

C

Indexing Narcotics, Fentanyl, and Opioids

7021.

Establishment of substance use disorder information dashboard

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

1711.

Establishment of substance use disorder information dashboard

(a)

In general

Not later than 6 months after the date of the enactment of this section, the Secretary of Health and Human Services shall, in consultation with the Director of National Drug Control Policy, establish and periodically update, on the Internet website of the Department of Health and Human Services, a public information dashboard that—

(1)

provides links to information on programs within the Department of Health and Human Services related to the reduction of opioid and other substance use disorders;

(2)

provides access, to the extent practicable and appropriate, to publicly available data, which may include data from agencies within the Department of Health and Human Services and—

(A)

other Federal agencies;

(B)

State, local, and Tribal governments;

(C)

nonprofit organizations;

(D)

law enforcement;

(E)

medical experts;

(F)

public health educators; and

(G)

research institutions regarding prevention, treatment, recovery, and other services for opioid and other substance use disorders;

(3)

provides data on substance use disorder prevention and treatment strategies in different regions of and populations in the United States;

(4)

identifies information on alternatives to controlled substances for pain management, such as approaches studied by the National Institutes of Health Pain Consortium, the National Center for Complimentary and Integrative Health, and other institutes and centers at the National Institutes of Health, as appropriate; and

(5)

identifies guidelines and best practices for health care providers regarding treatment of substance use disorders.

(b)

Controlled substance defined

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

.

7022.

Interdepartmental Substance Use Disorders Coordinating Committee

(a)

Establishment

Not later than 3 months 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, in coordination with the Director of National Drug Control Policy, establish a committee, to be known as the Interdepartmental Substance Use Disorders Coordinating Committee (in this section referred to as the Committee), to coordinate Federal activities related to substance use disorders.

(b)

Membership

(1)

Federal members

The Committee shall be composed of the following Federal representatives, or the designees of such representatives:

(A)

The Secretary, who shall serve as the Chair of the Committee.

(B)

The Attorney General of the United States.

(C)

The Secretary of Labor.

(D)

The Secretary of Housing and Urban Development.

(E)

The Secretary of Education.

(F)

The Secretary of Veterans Affairs.

(G)

The Commissioner of Social Security.

(H)

The Assistant Secretary for Mental Health and Substance Use.

(I)

The Director of National Drug Control Policy.

(J)

Representatives of other Federal agencies that support or conduct activities or programs related to substance use disorders, as determined appropriate by the Secretary.

(2)

Non-Federal members

The Committee shall include a minimum of 15 non-Federal members appointed by the Secretary, of which—

(A)

at least two such members shall be an individual who has received treatment for a diagnosis of a substance use disorder;

(B)

at least two such members shall be a director of a State substance abuse agency;

(C)

at least two such members shall be a representative of a leading research, advocacy, or service organization for adults with substance use disorder;

(D)

at least two such members shall—

(i)

be a physician, licensed mental health professional, advance practice registered nurse, or physician assistant; and

(ii)

have experience in treating individuals with substance use disorders;

(E)

at least one such member shall be a substance use disorder treatment professional who provides treatment services at a certified opioid treatment program;

(F)

at least one such member shall be a substance use disorder treatment professional who has research or clinical experience in working with racial and ethnic minority populations;

(G)

at least one such member shall be a substance use disorder treatment professional who has research or clinical mental health experience in working with medically underserved populations;

(H)

at least one such member shall be a State-certified substance use disorder peer support specialist;

(I)

at least one such member shall be a drug court judge or a judge with experience in adjudicating cases related to substance use disorder;

(J)

at least one such member shall be a public safety officer with extensive experience in interacting with adults with a substance use disorder; and

(K)

at least one such member shall be an individual with experience providing services for homeless individuals with a substance use disorder.

(c)

Terms

(1)

In general

A member of the Committee appointed under subsection (b)(2) shall be appointed for a term of 3 years and may be reappointed for one or more 3-year terms.

(2)

Vacancies

A vacancy on the Committee shall be filled in the same manner in which the original appointment was made. Any individual appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and may serve after the expiration of such term until a successor has been appointed.

(d)

Meetings

The Committee shall meet not fewer than two times each year.

(e)

Duties

The Committee shall—

(1)

identify areas for improved coordination of activities, if any, related to substance use disorders, including research, services, supports, and prevention activities across all relevant Federal agencies;

(2)

identify and provide to the Secretary recommendations for improving Federal programs for the prevention and treatment of, and recovery from, substance use disorders, including by expanding access to prevention, treatment, and recovery services;

(3)

analyze substance use disorder prevention and treatment strategies in different regions of and populations in the United States and evaluate the extent to which Federal substance use disorder prevention and treatment strategies are aligned with State and local substance use disorder prevention and treatment strategies;

(4)

make recommendations to the Secretary regarding any appropriate changes with respect to the activities and strategies described in paragraphs (1) through (3);

(5)

make recommendations to the Secretary regarding public participation in decisions relating to substance use disorders and the process by which public feedback can be better integrated into such decisions; and

(6)

make recommendations to ensure that substance use disorder research, services, supports, and prevention activities of the Department of Health and Human Services and other Federal agencies are not unnecessarily duplicative.

(f)

Annual report

Not later than 1 year after the date of the enactment of this Act, and annually thereafter for the life of the Committee, the Committee shall publish on the Internet website of the Department of Health and Human Services, which may include the public information dashboard established under section 1711 of the Public Health Service Act, as added by section 7021, a report summarizing the activities carried out by the Committee pursuant to subsection (e), including any findings resulting from such activities.

(g)

Working groups

The Committee may establish working groups for purposes of carrying out the duties described in subsection (e). Any such working group shall be composed of members of the Committee (or the designees of such members) and may hold such meetings as are necessary to enable the working group to carry out the duties delegated to the working group.

(h)

Federal Advisory Committee Act

The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Committee only to the extent that the provisions of such Act do not conflict with the requirements of this section.

(i)

Sunset

The Committee shall terminate on the date that is 6 years after the date on which the Committee is established under subsection (a).

7023.

National milestones to measure success in curtailing the opioid crisis

(a)

In general

Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary), in coordination with the Administrator of the Drug Enforcement Administration and the Director of the Office of National Drug Control Policy, shall develop or identify existing national indicators (referred to in this section as the national milestones) to measure success in curtailing the opioid crisis, with the goal of significantly reversing the incidence and prevalence of opioid misuse and abuse, and opioid-related morbidity and mortality in the United States within 5 years of such date of enactment.

(b)

National milestones to end the opioid crisis

The national milestones under subsection (a) shall include the following:

(1)

Not fewer than 10 indicators or metrics to accurately and expediently measure progress in meeting the goal described in subsection (a), which shall, as appropriate, include, indicators or metrics related to—

(A)

the number of fatal and non-fatal opioid overdoses;

(B)

the number of emergency room visits related to opioid misuse and abuse;

(C)

the number of individuals in sustained recovery from opioid use disorder;

(D)

the number of infections associated with illicit drug use, such as HIV, viral hepatitis, and infective endocarditis, and available capacity for treating such infections;

(E)

the number of providers prescribing medication-assisted treatment for opioid use disorders, including in primary care settings, community health centers, jails, and prisons;

(F)

the number of individuals receiving treatment for opioid use disorder; and

(G)

additional indicators or metrics, as appropriate, such as metrics pertaining to specific populations, including women and children, American Indians and Alaskan Natives, individuals living in rural and non-urban areas, and justice-involved populations, that would further clarify the progress made in addressing the opioid crisis.

(2)

A reasonable goal, such as a percentage decrease or other specified metric, that signifies progress in meeting the goal described in subsection (a), and annual targets to help achieve that goal.

(c)

Consideration of other substance use disorders

In developing the national milestones under subsection (b), the Secretary shall, as appropriate, consider other substance use disorders in addition to opioid use disorder.

(d)

Extension of period

If the Secretary determines that the goal described in subsection (a) will not be achieved with respect to any indicator or metric established under subsection (b)(2) within 5 years of the date of enactment of this Act, the Secretary may extend the timeline for meeting such goal with respect to that indicator or metric. The Secretary shall include with any such extension a rationale for why additional time is needed and information on whether significant changes are needed in order to achieve such goal with respect to the indicator or metric.

(e)

Annual status update

Not later than one year after the date of enactment of this Act, the Secretary shall make available on the Internet website of the Department of Health and Human Services, and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, an update on the progress, including expected progress in the subsequent year, in achieving the goals detailed in the national milestones. Each such update shall include the progress made in the first year or since the previous report, as applicable, in meeting each indicator or metric in the national milestones.

7024.

Study on prescribing limits

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Attorney General of the United States, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the impact of Federal and State laws and regulations that limit the length, quantity, or dosage of opioid prescriptions. Such report shall address—

(1)

the impact of such limits on—

(A)

the incidence and prevalence of overdose related to prescription opioids;

(B)

the incidence and prevalence of overdose related to illicit opioids;

(C)

the prevalence of opioid use disorders;

(D)

medically appropriate use of, and access to, opioids, including any impact on travel expenses and pain management outcomes for patients, whether such limits are associated with significantly higher rates of negative health outcomes, including suicide, and whether the impact of such limits differs based on the clinical indication for which opioids are prescribed;

(2)

whether such limits lead to a significant increase in burden for prescribers of opioids or prescribers of treatments for opioid use disorder, including any impact on patient access to treatment, and whether any such burden is mitigated by any factors such as electronic prescribing or telemedicine; and

(3)

the impact of such limits on diversion or misuse of any controlled substance in schedule II, III, or IV of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)).

D

Ensuring Access to Quality Sober Living

7031.

National recovery housing best practices

Part D of title V of the Public Health Service Act (42 U.S.C. 290dd et seq.) is amended by adding at the end the following new section:

550.

National recovery housing best practices

(a)

Best practices for operating recovery housing

(1)

In general

The Secretary, in consultation with the individuals and entities specified in paragraph (2), shall identify or facilitate the development of best practices, which may include model laws for implementing suggested minimum standards, for operating recovery housing.

(2)

Consultation

In carrying out the activities described in paragraph (1), the Secretary shall consult with, as appropriate—

(A)

relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Mental Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for Medicare & Medicaid Services;

(B)

the Secretary of Housing and Urban Development;

(C)

directors or commissioners, as applicable, of State health departments, tribal health departments, State Medicaid programs, and State insurance agencies;

(D)

representatives of health insurance issuers;

(E)

national accrediting entities and reputable providers of, and analysts of, recovery housing services, including Indian tribes, tribal organizations, and tribally designated housing entities that provide recovery housing services, as applicable;

(F)

individuals with a history of substance use disorder; and

(G)

other stakeholders identified by the Secretary.

(b)

Identification of fraudulent recovery housing operators

(1)

In general

The Secretary, in consultation with the individuals and entities described in paragraph (2), shall identify or facilitate the development of common indicators that could be used to identify potentially fraudulent recovery housing operators.

(2)

Consultation

In carrying out the activities described in paragraph (1), the Secretary shall consult with, as appropriate, the individuals and entities specified in subsection (a)(2) and the Attorney General of the United States.

(3)

Requirements

(A)

Practices for identification and reporting

In carrying out the activities described in paragraph (1), the Secretary shall consider how law enforcement, public and private payers, and the public can best identify and report fraudulent recovery housing operators.

(B)

Factors to be considered

In carrying out the activities described in paragraph (1), the Secretary shall identify or develop indicators, which may include indicators related to—

(i)

unusual billing practices;

(ii)

average lengths of stays;

(iii)

excessive levels of drug testing (in terms of cost or frequency); and

(iv)

unusually high levels of recidivism.

(c)

Dissemination

The Secretary shall, as appropriate, disseminate the best practices identified or developed under subsection (a) and the common indicators identified or developed under subsection (b) to—

(1)

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

(2)

Indian tribes, tribal organizations, and tribally designated housing entities;

(3)

the Attorney General of the United States;

(4)

the Secretary of Labor;

(5)

the Secretary of Housing and Urban Development;

(6)

State and local law enforcement agencies;

(7)

health insurance issuers;

(8)

recovery housing entities; and

(9)

the public.

(d)

Requirements

In carrying out the activities described in subsections (a) and (b), the Secretary, in consultation with appropriate individuals and entities described in subsections (a)(2) and (b)(2), shall consider how recovery housing is able to support recovery and prevent relapse, recidivism, or overdose (including overdose death), including by improving access and adherence to treatment, including medication-assisted treatment.

(e)

Rule of construction

Nothing in this section shall be construed to provide the Secretary with the authority to require States to adhere to minimum standards in the State oversight of recovery housing.

(f)

Definitions

In this section:

(1)

The term recovery housing means a shared living environment free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders.

(2)

The terms Indian tribe and tribal organization have the meanings given those terms in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).

(3)

The term tribally designated housing entity has the meaning given that term in section 4 of the Native American Housing Assistance and Self-Determination Act of 1996 (25 U.S.C. 4103).

(g)

Authorization of appropriations

To carry out this section, there is authorized to be appropriated $3,000,000 for the period of fiscal years 2019 through 2021.

.

E

Advancing Cutting Edge Research

7041.

Unique research initiatives

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

(1)

in subparagraph (A), by striking or;

(2)

in subparagraph (B), by striking the period and inserting ; or; and

(3)

by adding at the end the following:

(C)

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

.

7042.

Pain research

Section 409J(b) of the Public Health Service Act (42 U.S.C. 284q(b)) is amended—

(1)

in paragraph (5)—

(A)

in subparagraph (A), by striking and treatment of pain and diseases and disorders associated with pain and inserting treatment, and management of pain and diseases and disorders associated with pain, including information on best practices for the utilization of non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration;

(B)

in subparagraph (B), by striking on the symptoms and causes of pain; and inserting the following: “on—

(i)

the symptoms and causes of pain, including the identification of relevant biomarkers and screening models and the epidemiology of acute and chronic pain;

(ii)

the diagnosis, prevention, treatment, and management of acute and chronic pain, including with respect to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; and

(iii)

risk factors for, and early warning signs of, substance use disorders in populations with acute and chronic pain; and

; and

(C)

by striking subparagraphs (C) through (E) and inserting the following:

(C)

make recommendations to the Director of NIH—

(i)

to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort;

(ii)

on how best to disseminate information on pain care and epidemiological data related to acute and chronic pain; and

(iii)

on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research.

;

(2)

by redesignating paragraph (6) as paragraph (7); and

(3)

by inserting after paragraph (5) the following:

(6)

Report

The Secretary shall ensure that recommendations and actions taken by the Director with respect to the topics discussed at the meetings described in paragraph (4) are included in appropriate reports to Congress.

.

F

Jessie’s Law

7051.

Inclusion of opioid addiction history in patient records

(a)

Best practices

(1)

In general

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary), in consultation with appropriate stakeholders, including a patient with a history of opioid use disorder, an expert in electronic health records, an expert in the confidentiality of patient health information and records, and a health care provider, shall identify or facilitate the development of best practices regarding—

(A)

the circumstances under which information that a patient has provided to a health care provider regarding such patient’s history of opioid use disorder should, only at the patient’s request, be prominently displayed in the medical records (including electronic health records) of such patient;

(B)

what constitutes the patient’s request for the purpose described in subparagraph (A); and

(C)

the process and methods by which the information should be so displayed.

(2)

Dissemination

The Secretary shall disseminate the best practices developed under paragraph (1) to health care providers and State agencies.

(b)

Requirements

In identifying or facilitating the development of best practices under subsection (a), as applicable, the Secretary, in consultation with appropriate stakeholders, shall consider the following:

(1)

The potential for addiction relapse or overdose, including overdose death, when opioid medications are prescribed to a patient recovering from opioid use disorder.

(2)

The benefits of displaying information about a patient’s opioid use disorder history in a manner similar to other potentially lethal medical concerns, including drug allergies and contraindications.

(3)

The importance of prominently displaying information about a patient’s opioid use disorder when a physician or medical professional is prescribing medication, including methods for avoiding alert fatigue in providers.

(4)

The importance of a variety of appropriate medical professionals, including physicians, nurses, and pharmacists, having access to information described in this section when prescribing or dispensing opioid medication, consistent with Federal and State laws and regulations.

(5)

The importance of protecting patient privacy, including the requirements related to consent for disclosure of substance use disorder information under all applicable laws and regulations.

(6)

All applicable Federal and State laws and regulations.

7052.

Communication with families during emergencies

(a)

Promoting awareness of authorized disclosures during emergencies

The Secretary of Health and Human Services shall annually notify health care providers regarding permitted disclosures under Federal health care privacy law during emergencies, including overdoses, of certain health information to families, caregivers, and health care providers.

(b)

Use of material

For the purposes of carrying out subsection (a), the Secretary of Health and Human Services may use material produced under section 7053 of this Act or section 11004 of the 21st Century Cures Act (42 U.S.C. 1320d–2 note).

7053.

Development and dissemination of model training programs for substance use disorder patient records

(a)

Initial programs and materials

Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary), in consultation with appropriate experts, shall identify the following model programs and materials (or if no such programs or materials exist, recognize private or public entities to develop and disseminate such programs and materials):

(1)

Model programs and materials for training health care providers (including physicians, emergency medical personnel, psychiatrists, psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care managers, and hospitals, including individuals such as general counsels or regulatory compliance staff who are responsible for establishing provider privacy policies) concerning the permitted uses and disclosures, consistent with the standards and regulations governing the privacy and security of substance use disorder patient records promulgated by the Secretary under section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) for the confidentiality of patient records.

(2)

Model programs and materials for training patients and their families regarding their rights to protect and obtain information under the standards and regulations described in paragraph (1).

(b)

Requirements

The model programs and materials described in paragraphs (1) and (2) of subsection (a) shall address circumstances under which disclosure of substance use disorder patient records is needed to—

(1)

facilitate communication between substance use disorder treatment providers and other health care providers to promote and provide the best possible integrated care;

(2)

avoid inappropriate prescribing that can lead to dangerous drug interactions, overdose, or relapse; and

(3)

notify and involve families and caregivers when individuals experience an overdose.

(c)

Periodic updates

The Secretary shall—

(1)

periodically review and update the model program and materials identified or developed under subsection (a); and

(2)

disseminate such updated programs and materials to the individuals described in subsection (a)(1).

(d)

Input of certain entities

In identifying, reviewing, or updating the model programs and materials under this section, the Secretary shall solicit the input of relevant stakeholders.

(e)

Authorization of appropriations

There is authorized to be appropriated to carry out this section—

(1)

$4,000,000 for fiscal year 2019;

(2)

$2,000,000 for each of fiscal years 2020 and 2021; and

(3)

$1,000,000 for each of fiscal years 2022 and 2023.

G

Protecting Pregnant Women and Infants

7061.

Report on addressing maternal and infant health in the opioid crisis

(a)

In general

Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Centers for Disease Control and Prevention, the National Institutes of Health, the Indian Health Service, and the Substance Abuse and Mental Health Services Administration, shall develop and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes—

(1)

information on opioid, non-opioid, and non-pharmacologic pain management practices during pregnancy and after pregnancy;

(2)

recommendations for increasing public awareness and education about substance use disorders, including opioid use disorders, during and after pregnancy, including available treatment resources in urban and rural areas;

(3)

recommendations to prevent, identify, and reduce substance use disorders, including opioid use disorders, during pregnancy to improve care for pregnant women with substance use disorders and their infants; and

(4)

an identification of areas in need of further research with respect to acute and chronic pain management during and after pregnancy.

(b)

No additional funds

No additional funds are authorized to be appropriated for purposes of carrying out subsection (a).

7062.

Protecting moms and infants

(a)

Report

(1)

In general

Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make available to the public on the Internet website of the Department of Health and Human Services, a report regarding the implementation of the recommendations in the strategy relating to prenatal opioid use, including neonatal abstinence syndrome, developed pursuant to section 2 of the Protecting Our Infants Act of 2015 (Public Law 114–91). Such report shall include—

(A)

an update on the implementation of the recommendations in the strategy, including information regarding the agencies involved in the implementation; and

(B)

information on additional funding or authority the Secretary requires, if any, to implement the strategy, which may include authorities needed to coordinate implementation of such strategy across the Department of Health and Human Services.

(2)

Periodic updates

The Secretary shall periodically update the report under paragraph (1).

(b)

Residential treatment programs for pregnant and postpartum women

Section 508(s) of the Public Health Service Act (42 U.S.C. 290bb–1(s)) is amended by striking $16,900,000 for each of fiscal years 2017 through 2021 and inserting $29,931,000 for each of fiscal years 2019 through 2023.

7063.

Early interventions for pregnant women and infants

(a)

Development of educational materials by Center for Substance Abuse Prevention

Section 515(b) of the Public Health Service Act (42 U.S.C. 290bb–21(b)) is amended—

(1)

in paragraph (13), by striking and at the end;

(2)

in paragraph (14), by striking the period at the end and inserting ; and; and

(3)

by adding at the end the following:

(15)

in consultation with relevant stakeholders and in collaboration with the Director of the Centers for Disease Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared decision making regarding pain management and the prevention of substance use disorders during pregnancy.

.

(b)

Guidelines and recommendations by Center for Substance Abuse Treatment

Section 507(b) of the Public Health Service Act (42 U.S.C. 290bb(b)) is amended—

(1)

in paragraph (13), by striking and at the end;

(2)

in paragraph (14), by striking the period at the end and inserting a semicolon; and

(3)

by adding at the end the following:

(15)

in cooperation with the Secretary, implement and disseminate, as appropriate, the recommendations in the report entitled Protecting Our Infants Act: Final Strategy issued by the Department of Health and Human Services in 2017; and

.

(c)

Support of partnerships by Center for Substance Abuse Treatment

Section 507(b) of the Public Health Service Act (42 U.S.C. 290bb(b)), as amended by subsection (b), is further amended by adding at the end the following:

(16)

in cooperation with relevant stakeholders, and through public-private partnerships, encourage education about substance use disorders for pregnant women and health care providers who treat pregnant women and babies.

.

7064.

Prenatal and postnatal health

Section 317L of the Public Health Service Act (42 U.S.C. 247b–13) is amended—

(1)

in subsection (a)—

(A)

by amending paragraph (1) to read as follows:

(1)

to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and misuse, including—

(A)

data on—

(i)

the incidence, prevalence, and implications of such activities; and

(ii)

the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other maternal and child health outcomes associated with such activities; and

(B)

additional information or data, as appropriate, on family health history, medication exposures during pregnancy, demographic information, such as race, ethnicity, geographic location, and family history, and other relevant information, to inform such analysis;

;

(B)

in paragraph (2)—

(i)

by striking prevention of and inserting prevention and long-term outcomes associated with; and

(ii)

by striking illegal drug use and inserting other substance abuse and misuse;

(C)

in paragraph (3), by striking and cessation programs; and and inserting , treatment, and cessation programs;;

(D)

in paragraph (4), by striking illegal drug use. and inserting other substance abuse and misuse; and; and

(E)

by adding at the end the following:

(5)

to issue public reports on the analysis of data described in paragraph (1), including analysis of—

(A)

long-term outcomes of children affected by neonatal abstinence syndrome;

(B)

health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and

(C)

relevant studies, evaluations, or information the Secretary determines to be appropriate.

;

(2)

in subsection (b), by inserting tribal entities, after local governments,;

(3)

by redesignating subsection (c) as subsection (d);

(4)

by inserting after subsection (b) the following:

(c)

Coordinating activities

To carry out this section, the Secretary may—

(1)

provide technical and consultative assistance to entities receiving grants under subsection (b);

(2)

ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease Control and Prevention;

(3)

ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy laws; and

(4)

coordinate with the National Coordinator for Health Information Technology, as appropriate, to assist States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such recognized standards are available, in order to facilitate interoperability between such systems and health information technology systems, including certified health information technology.

; and

(5)

in subsection (d), as so redesignated, by striking 2001 through 2005 and inserting 2019 through 2023.

7065.

Plans of safe care

(a)

In general

Section 105(a) of the Child Abuse Prevention and Treatment Act (42 U.S.C. 5106(a)) is amended by adding at the end the following:

(7)

Grants to States to improve and coordinate their response to ensure the safety, permanency, and well-being of infants affected by substance use

(A)

Program authorized

The Secretary is authorized to make grants to States for the purpose of assisting child welfare agencies, social services agencies, substance use disorder treatment agencies, hospitals with labor and delivery units, medical staff, public health and mental health agencies, and maternal and child health agencies to facilitate collaboration in developing, updating, implementing, and monitoring plans of safe care described in section 106(b)(2)(B)(iii). Section 112(a)(2) shall not apply to the program authorized under this paragraph.

(B)

Distribution of funds

(i)

Reservations

Of the amounts made available to carry out subparagraph (A), the Secretary shall reserve—

(I)

no more than 3 percent for the purposes described in subparagraph (G); and

(II)

up to 3 percent for grants to Indian Tribes and tribal organizations to address the needs of infants born with, and identified as being affected by, substance abuse or withdrawal symptoms resulting from prenatal drug exposure or a fetal alcohol spectrum disorder and their families or caregivers, which to the extent practicable, shall be consistent with the uses of funds described under subparagraph (D).

(ii)

Allotments to States and territories

The Secretary shall allot the amount made available to carry out subparagraph (A) that remains after application of clause (i) to each State that applies for such a grant, in an amount equal to the sum of—

(I)

$500,000; and

(II)

an amount that bears the same relationship to any funds made available to carry out subparagraph (A) and remaining after application of clause (i), as the number of live births in the State in the previous calendar year bears to the number of live births in all States in such year.

(iii)

Ratable reduction

If the amount made available to carry out subparagraph (A) is insufficient to satisfy the requirements of clause (ii), the Secretary shall ratably reduce each allotment to a State.

(C)

Application

A State desiring a grant under this paragraph shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include—

(i)

a description of—

(I)

the impact of substance use disorder in such State, including with respect to the substance or class of substances with the highest incidence of abuse in the previous year in such State, including—

(aa)

the prevalence of substance use disorder in such State;

(bb)

the aggregate rate of births in the State of infants affected by substance abuse or withdrawal symptoms or a fetal alcohol spectrum disorder (as determined by hospitals, insurance claims, claims submitted to the State Medicaid program, or other records), if available and to the extent practicable; and

(cc)

the number of infants identified, for whom a plan of safe care was developed, and for whom a referral was made for appropriate services, as reported under section 106(d)(18);

(II)

the challenges the State faces in developing, implementing, and monitoring plans of safe care in accordance with section 106(b)(2)(B)(iii);

(III)

the State’s lead agency for the grant program and how that agency will coordinate with relevant State entities and programs, including the child welfare agency, the substance use disorder treatment agency, hospitals with labor and delivery units, health care providers, the public health and mental health agencies, programs funded by the Substance Abuse and Mental Health Services Administration that provide substance use disorder treatment for women, the State Medicaid program, the State agency administering the block grant program under title V of the Social Security Act (42 U.S.C. 701 et seq.), the State agency administering the programs funded under part C of the Individuals with Disabilities Education Act (20 U.S.C. 1431 et seq.), the maternal, infant, and early childhood home visiting program under section 511 of the Social Security Act (42 U.S.C. 711), the State judicial system, and other agencies, as determined by the Secretary, and Indian Tribes and tribal organizations, as appropriate, to implement the activities under this paragraph;

(IV)

how the State will monitor local development and implementation of plans of safe care, in accordance with section 106(b)(2)(B)(iii)(II), including how the State will monitor to ensure plans of safe care address differences between substance use disorder and medically supervised substance use, including for the treatment of a substance use disorder;

(V)

if applicable, how the State plans to utilize funding authorized under part E of title IV of the Social Security Act (42 U.S.C. 670 et seq.) to assist in carrying out any plan of safe care, including such funding authorized under section 471(e) of such Act (as in effect on October 1, 2018) for mental health and substance abuse prevention and treatment services and in-home parent skill-based programs and funding authorized under such section 472(j) (as in effect on October 1, 2018) for children with a parent in a licensed residential family-based treatment facility for substance abuse; and

(VI)

an assessment of the treatment and other services and programs available in the State to effectively carry out any plan of safe care developed, including identification of needed treatment, and other services and programs to ensure the well-being of young children and their families affected by s