In the House of Representatives, U. S., 
September 28, 2018. 
Resolved, That the House agree to the amendment of the 
Senate to the bill (H.R. 6) entitled ‘‘An Act to provide for 
opioid use disorder prevention, recovery, and treatment, and 
for other purposes.’’, with the following 
HOUSE AMENDMENT TO SENATE AMENDMENT: 
In lieu of the matter proposed to be inserted by the 
Senate amendment, insert the following 
SECTION 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 syn-
drome and their mothers; GAO study on gaps in Medicaid cov-
erage 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 hous-
ing-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 treat-
ment 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 cov-
erage information for purposes of identifying primary payer sit-
uations under the Medicare program. 
Sec. 4003. Additional religious exemption from health coverage responsibility re-
quirement. 
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 dis-
eases 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 adop-
tion 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 sen-
iors. 
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 pro-
gram 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 guid-
ance 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 man-
agement. 
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 sub-
stance 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 work-
force. 
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 dis-
order 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 trau-
ma. 
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 edu-
cation 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 sub-
stance 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 re-
quirements 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 dis-
order 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 data-
base. 
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; addi-
tion 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 In-
stitute. 
Sec. 8205. Reauthorization of the High-Intensity Drug Trafficking Area Pro-
gram. 
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. 
TITLE I—MEDICAID PROVISIONS 
TO ADDRESS THE OPIOID CRISIS 
SEC. 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 para-
graph (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 de-
fined 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 indi-
vidual’s release from such a public institution, 
conduct a redetermination of eligibility for such 
individual with respect to such medical assist-
ance (without requiring a new application from 
the individual) and, if the State determines pur-
suant to such redetermination that the indi-
vidual continues to meet the eligibility require-
ments 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 ap-
plication for medical assistance submitted by, or 
on behalf of, such individual such that the State 
makes a determination of eligibility for such in-
dividual 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 sub-
section: 
‘‘(nn) JUVENILE; ELIGIBLE JUVENILE; PUBLIC INSTI-
TUTION.—For purposes of subsection (a)(84) and this sub-
section: 
‘‘(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 ju-
venile’ means a juvenile who is an inmate of a public 
institution and who—
‘‘(A) was determined eligible for medical as-
sistance 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 institu-
tion. 
‘‘(3) INMATE OF A PUBLIC INSTITUTION.—The 
term ‘inmate of a public institution’ has the meaning 
given such term for purposes of applying the subdivi-
sion (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 AS-
SISTANCE FOR INMATES OF PUBLIC INSTITUTIONS.—Noth-
ing in this section shall be construed as changing the exclu-
sion from medical assistance under the subdivision (A) fol-
lowing paragraph (30) of section 1905(a) of the Social Se-
curity Act (42 U.S.C. 1396d(a)), as redesignated by section 
1006(b)(2)(B) of this Act, including any applicable restric-
tions on a State submitting claims for Federal financial 
participation under title XIX of such Act for such assist-
ance. 
(c) NO CHANGE IN CONTINUITY OF ELIGIBILITY BE-
FORE 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 para-
graph (2), the amendments made by subsection (a) 
shall apply to eligibility of juveniles who become in-
mates 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 LEG-
ISLATION.—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 legis-
lation 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 re-
quirements of such title solely on the basis of its fail-
ure 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 legis-
lature 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 sepa-
rate regular session of the State legislature. 
SEC. 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 de-
scribed 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 fos-
ter youth who attain 18 years of age on or after Jan-
uary 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 stream-
lined, timely access to Medicaid coverage for 
former foster youth up to age 26; and 
(B) conducting outreach and raising aware-
ness among such youth regarding Medicaid cov-
erage 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. 
SEC. 1003. DEMONSTRATION PROJECT TO INCREASE SUB-
STANCE 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 SUB-
STANCE 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 ap-
propriate, with the Director of the Agency for 
Healthcare Research and Quality and the Assistant
Use for purposes of carrying out the re-
quirements 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 ex-
pansion 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 recov-
ery needs of— 
‘‘(i) individuals enrolled under the 
State plan (or a waiver of such plan) who 
have neonatal abstinence syndrome, in ac-
cordance with guidelines issued by the 
American Academy of Pediatrics and Amer-
ican College of Obstetricians and Gyne-
cologists relating to maternal care and in-
fant care with respect to neonatal absti-
nence syndrome; 
‘‘(ii) pregnant women, postpartum 
women, and infants, particularly the con-
current treatment, as appropriate, and com-
prehensive case management of pregnant
women, postpartum women and infants, en-
rolled under the State plan (or a waiver of 
such plan); 
‘‘(iii) adolescents and young adults be-
tween the ages of 12 and 21 enrolled under 
the State plan (or a waiver of such plan); 
or 
‘‘(iv) American Indian and Alaska Na-
tive 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 para-
graph (1), award planning grants to at least 10 
States selected in accordance with subparagraph 
(B) for purposes of preparing an application de-
scribed 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 en-
sures geographic diversity; and 
‘‘(iii) give preference to States with a 
prevalence of substance use disorders (in 
particular opioid use disorders) that is com-
parable to or higher than the national aver-
age prevalence, as measured by aggregate 
per capita drug overdoses, or any other 
measure that the Secretary deems appro-
priate. 
‘‘(C) ACTIVITIES
DESCRIBED.—Activities 
described in this subparagraph are, with respect 
to a State, each of the following: 
‘‘(i) Activities that support the develop-
ment of an initial assessment of the behav-
ioral health treatment needs of the State to 
determine the extent to which providers are 
needed (including the types of such pro-
viders and geographic area of need) to im-
prove 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 informa-
tion 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 re-
covery 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 offer-
ing 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 ac-
count 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 treat-
ment 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 subpara-
graph (A), there is appropriated, out of any 
funds in the Treasury not otherwise appro-
priated, $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 para-
graph (1), select not more than 5 States in ac-
cordance with subparagraph (B) for purposes of 
carrying out the activities described in para-
graph (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 plan-
ning 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 com-
parable to or higher than the national aver-
age prevalence, as measured by aggregate 
per capita drug overdoses, or any other 
measure that the Secretary deems appro-
priate. 
‘‘(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 Sec-
retary requires, an application that in-
cludes such information, provisions, and as-
surances, as the Secretary may require, in 
addition to the following:
‘‘(I) A proposed process for car-
rying out the ongoing assessment de-
scribed 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 de-
livering 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 sustain-
able provider networks under the State 
plan (or waiver) that will offer a con-
tinuum of care for substance use dis-
orders. Such plan shall include the fol-
lowing: 
‘‘(aa) Specific activities to 
increase the number of providers 
(including providers that spe-
cialize in providing substance use 
disorder treatment or recovery 
services, hospitals, health care sys-
tems, Federally qualified health 
centers, and, as applicable, cer-
tified 
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 nec-
essary training, education, and 
support to deliver substance use 
disorder treatment or recovery 
services in the State. 
‘‘(cc) Milestones and timeli-
ness for implementing activities 
set forth in the plan.
‘‘(dd) 
Specific 
measurable 
targets for increasing the sub-
stance use disorder treatment and 
recovery provider network under 
the State plan (or a waiver of 
such plan). 
‘‘(IV) A proposed process for re-
porting the information required under 
paragraph (6)(A), including informa-
tion to assess the effectiveness of the ef-
forts of the State to expand the capac-
ity 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 im-
pact of the demonstration project under 
this subsection on the State. 
‘‘(VI) A description of all funding 
sources available to the State to pro-
vide 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 re-
covery services resulting from the dem-
onstration project under this subsection 
after the termination of such dem-
onstration 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, in-
cluding Medicaid managed care plans, 
health care providers, and Medicaid bene-
ficiary advocates, and include in such ap-
plication a description of such consultation. 
‘‘(5) PAYMENT.— 
‘‘(A) IN GENERAL.—For each quarter occur-
ring during the period for which the demonstra-
tion 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 pur-
poses of subparagraph (A), the term ‘qualified 
sums’ means, with respect to a State and a quar-
ter, the amount equal to the amount (if any) by 
which the sums expended by the State during 
such quarter attributable to substance use dis-
order 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 subpara-
graph (A) with respect to expenditures for sub-
stance 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 pe-
riod of the demonstration project under this sub-
section, submit to the Secretary a quarterly re-
port, 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 de-
livered substance use disorder treatment or 
recovery services in the State under the 
demonstration project compared to the esti-
mated number of providers that would have 
otherwise delivered such services in the ab-
sence of such demonstration project. 
‘‘(iii) The number of individuals en-
rolled under the State plan (or a waiver of 
such plan) who received substance use dis-
order 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 se-
lection; 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 Serv-
ices 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 dem-
onstration project; and 
‘‘(IV) with a plan for the sustain-
ability 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 sub-
section after the submission of such in-
terim report; and 
‘‘(III) evaluating such demonstra-
tion project. 
‘‘(C) AHRQ REPORT.—Not later than 3 
years after the date of the enactment of this sub-
section, 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 be-
tween such States and States that were not so selected.
‘‘(8) CMS FUNDING.—There is appropriated, out 
of any funds in the Treasury not otherwise appro-
priated, $5,000,000 to the Centers for Medicare & 
Medicaid Services for purposes of implementing this 
subsection. Such amount shall remain available until 
expended.’’. 
SEC. 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 strik-
ing ‘‘and’’; 
(B) in paragraph (84), at the end, by strik-
ing 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 REQUIRE-
MENTS.—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 sub-
section: 
‘‘(oo) DRUG REVIEW
AND UTILIZATION REQUIRE-
MENTS.— 
‘‘(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 mor-
phine 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 identi-
fied 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 re-
spect to which the State has a contract 
under section 1903(m) or under section 
1905(t)(3) to have in place, subject to para-
graph (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 con-
strued as prohibiting a State or managed 
care entity from designing and imple-
menting 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 en-
rolled 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 appro-
priate use of antipsychotic medications by chil-
dren enrolled under the State plan (or under a 
waiver of the State plan) and submits annually 
to the Secretary such information as the Sec-
retary 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 en-
rolled, and pharmacies dispensing drugs to indi-
viduals 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 pre-
vent a State from satisfying the requirement— 
‘‘(i) described in subparagraph (A) by 
having safety edits or a claims review auto-
mated process described in such subpara-
graph that was in place before October 1, 
2019; 
‘‘(ii) described in subparagraph (B) by 
having a program described in such sub-
paragraph that was in place before such 
date; or 
‘‘(iii) described in subparagraph (C) 
by having a process described in such sub-
paragraph that was in place before such 
date. 
‘‘(2) ANNUAL REPORT BY SECRETARY.—For each 
fiscal year beginning with fiscal year 2020, the Sec-
retary shall submit to Congress a report on the most 
recent information submitted by States under para-
graph (1)(D). 
‘‘(3) EXCEPTIONS.— 
‘‘(A) CERTAIN
INDIVIDUALS
EXEMPTED.— 
The drug review and utilization requirements
under this subsection shall not apply with re-
spect 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 fre-
quently abused drugs are dispensed for resi-
dents through a contract with a single phar-
macy; or 
‘‘(iii) the State elects to treat as ex-
empted 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 sub-
section: 
‘‘(i) DRUG UTILIZATION REVIEW ACTIVITIES AND RE-
QUIREMENTS.—Beginning not later than October 1, 2019, 
each contract under a State plan with a managed care enti-
ty (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 MED-
ICAID.— 
(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 ret-
rospective drug use reviews conducted on or after Oc-
tober 1, 2020. 
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. 
(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 fami-
lies. Such guidance shall include— 
(1) best practices from States with respect to in-
novative 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 fi-
nancing 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 dis-
orders, 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 ab-
stinence 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 Med-
icaid program under such title. 
SEC. 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 para-
graph:
proved under this section that include SUD-eli-
gible 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 indi-
vidual with a substance use disorder. 
‘‘(III) The individual has not pre-
viously received health home services 
under any other State plan amend-
ment 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 de-
signed to provide health home services pri-
marily to SUD-eligible individuals.’’.
(b) REQUIREMENT FOR STATE MEDICAID PLANS TO 
PROVIDE COVERAGE FOR MEDICATION-ASSISTED TREAT-
MENT.— 
(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 amend-
ed, in the matter preceding clause (i), by striking 
‘‘and (28)’’ and inserting ‘‘(28), and (29)’’. 
(2) INCLUSION OF MEDICATION-ASSISTED TREAT-
MENT 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
DE-
FINED; WAIVERS.—Section 1905 of the Social Secu-
rity 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 sec-
tion 505 of the Federal Food, Drug, and Cos-
metic 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 con-
tract 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 Serv-
ices determines requires State legislation in 
order for the respective plan to meet any require-
ment imposed by the amendments made by this 
subsection, the respective plan shall not be re-
garded as failing to comply with the require-
ments of such title solely on the basis of its fail-
ure to meet such an additional requirement be-
fore the first day of the first calendar quarter be-
ginning 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 ses-
sion shall be considered to be a separate regular 
session of the State legislature. 
SEC. 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 fol-
lowing 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 DE-
FINED.—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 sig-
nificant medical risk factors. 
‘‘(2) COUNSELING AND SERVICES.—A residential 
pediatric recovery center may offer counseling and 
other services to mothers (and other appropriate fam-
ily members and caretakers) of infants receiving 
treatment at such centers if such services are other-
wise 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-in-
fant 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.
SEC. 1008. PEER SUPPORT ENHANCEMENT AND EVALUA-
TION 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 En-
ergy 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 experi-
ences 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.
SEC. 1009. MEDICAID SUBSTANCE USE DISORDER TREAT-
MENT VIA TELEHEALTH. 
(a) DEFINITIONS.—In this section: 
(1) COMPTROLLER GENERAL.—The term ‘‘Comp-
troller 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 ‘‘under-
served 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 designa-
tion 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 RE-
IMBURSEMENT FOR FURNISHING SERVICES AND TREAT-
MENT FOR SUBSTANCE USE DISORDERS UNDER MEDICAID 
USING SERVICES DELIVERED VIA TELEHEALTH, INCLUD-
ING 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 Medi-
care & 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 de-
livered via telehealth. Such guidance shall also in-
clude guidance on furnishing services and treatments 
that address the needs of high-risk individuals, in-
cluding 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 sub-
stance use disorders using the hub and spoke model, 
through contracts with managed care entities, through 
administrative claiming for disease management ac-
tivities, 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 individ-
uals 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 DIS-
ORDERS UNDER MEDICAID.— 
(1) STUDY.—The Comptroller General shall 
evaluate children’s access to services and treatment 
for substance use disorders under Medicaid. The eval-
uation shall include an analysis of State options for 
improving children’s access to such services and treat-
ment and for improving outcomes, including by in-
creasing 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 re-
sults of the evaluation conducted under paragraph 
(1), together with recommendations for such legisla-
tion and administrative action as the Comptroller 
General determines appropriate. 
(d) REPORT ON REDUCING BARRIERS TO USING SERV-
ICES DELIVERED VIA TELEHEALTH AND REMOTE PATIENT 
MONITORING FOR PEDIATRIC POPULATIONS UNDER MED-
ICAID.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary, act-
ing through the Administrator of the Centers for 
Medicare & Medicaid Services, shall issue a report to 
the Committee on Finance of the Senate and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives identifying best practices and potential 
solutions for reducing barriers to using services deliv-
ered via telehealth to furnish services and treatment 
for substance use disorders among pediatric popu-
lations under Medicaid. The report shall include— 
(A) analyses of the best practices, barriers, 
and potential solutions for using services deliv-
ered via telehealth to diagnose and provide serv-
ices and treatment for children with substance 
use disorders, including opioid use disorder; and
(B) identification and analysis of the dif-
ferences, if any, in furnishing services and treat-
ment 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 satis-
faction. 
(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. 
SEC. 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 Adminis-
trator of the Centers for Medicare & Medicaid Services, 
shall issue 1 or more final guidance documents, or update 
existing guidance documents, to States regarding manda-
tory 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 thera-
pies. 
SEC. 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 regard-
ing 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 anal-
yses of each of the following models of distribution of 
substance use disorder treatment medications, par-
ticularly 
buprenorphine, 
naltrexone, 
and 
buprenorphine-naloxone combinations: 
(A) The purchasing, storage, and adminis-
tration of substance use disorder treatment medi-
cations by providers.
(B) The dispensing of substance use dis-
order treatment medications by pharmacists. 
(C) The ordering, prescribing, and obtain-
ing substance use disorder treatment medications 
on demand from specialty pharmacies by pro-
viders. 
(2) REQUIREMENTS.—For each model of dis-
tribution specified in paragraph (1), the Comptroller 
General shall evaluate how each model presents bar-
riers or could be used by selected State Medicaid pro-
grams 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 dis-
tribution on— 
(A) Medicaid beneficiaries’ access to sub-
stance use disorder treatment medications; 
(B) the differential cost to the program be-
tween each distribution model for medication-as-
sisted treatment; and 
(C) provider willingness to provide or pre-
scribe substance use disorder treatment medica-
tions. 
(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 rec-
ommendations for such legislation and administrative ac-
tion as the Comptroller General determines appropriate. 
SEC. 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 dis-
order, 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 para-
graph (2), the amendment made by subsection (a) 
shall take effect on the date of enactment of this Act. 
(2) RULE FOR CHANGES REQUIRING STATE LEG-
ISLATION.—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 re-
quirements imposed by the amendment made by sub-
section (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 addi-
tional 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 pur-
poses 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 ses-
sion of the State legislature.
SEC. 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 sec-
tion 438.6(e) of title 42, Code of Federal Regulations (or 
any successor regulation).’’. 
SEC. 1014. MACPAC STUDY AND REPORT ON MAT UTILIZA-
TION 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 con-
trol policies and related protocols for ensuring access 
to medically necessary treatment; 
(2) determine whether managed care utilization 
control policies and procedures for medication-as-
sisted treatment for substance use disorders are con-
sistent 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 medica-
tion-assisted treatment for a substance use dis-
order by limiting the quantity of medication-as-
sisted treatment prescriptions, or the number of 
refills for such prescriptions, available to the in-
dividual 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 re-
port containing the results of the study conducted under 
subsection (a). 
SEC. 1015. OPIOID ADDICTION TREATMENT PROGRAMS EN-
HANCEMENT. 
(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 pro-
vided 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 ex-
tent 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 individ-
uals enrolled in the State Medicaid plan or 
waiver of such plan in each of the major enroll-
ment categories (as defined in a public letter 
from the Medicaid and CHIP Payment and Ac-
cess 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 treat-
ment, 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 individ-
uals with a substance use disorder diagnosis en-
rolled 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 out-
patient, 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 di-
agnosis enrolled in such plan or waiver for each 
major type of service under subparagraph (B). 
(E) The number and percentage of individ-
uals enrolled in the State Medicaid plan or 
waiver, by major enrollment category, who re-
ceived 
substance 
use 
disorder 
treatment 
through—
(i) a medicaid managed care entity (as 
defined in section 1932(a)(1)(B) of the So-
cial 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 individ-
uals 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 cal-
endar 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 Sec-
retary by the State that is sufficient to commu-
nicate the appropriate uses for the information. 
(b) MAKING T–MSIS DATA ON SUBSTANCE USE DIS-
ORDERS 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 accord-
ance 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 treat-
ment 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 no-
tice required under paragraph (1). 
SEC. 1016. BETTER DATA SHARING TO COMBAT THE OPIOID 
CRISIS. 
(a) IN GENERAL.—Section 1903(m) of the Social Secu-
rity 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 ac-
cess, 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 sub-
section (a) shall take effect on the date of enactment of this 
Act. 
SEC. 1017. REPORT ON INNOVATIVE STATE INITIATIVES 
AND STRATEGIES TO PROVIDE HOUSING-RE-
LATED SERVICES AND SUPPORTS TO INDIVID-
UALS 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 Med-
icaid program to individuals with substance use disorders 
who are experiencing or at risk of experiencing homeless-
ness. 
(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 dis-
order 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, hos-
pitals, accountable care organizations, and other care 
coordination providers to deliver housing-related serv-
ices and supports and to coordinate services provided 
under State Medicaid programs across different treat-
ment 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 de-
signing, securing, and implementing such waiv-
ers or plan amendments;
(B) how States developed partnerships with 
other organizations such as behavioral health 
agencies, State housing agencies, housing pro-
viders, health care services agencies and pro-
viders, 
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 cov-
ering such services and supports under State 
Medicaid plans or waivers. 
(4) Existing opportunities for States to provide 
housing-related services and supports through a Med-
icaid waiver under sections 1115 or 1915 of the So-
cial Security Act (42 U.S.C. 1315, 1396n) or through 
a State Medicaid plan amendment, such as the As-
sistance in Community Integration Service pilot pro-
gram, which promotes supportive housing and other 
housing-related supports under Medicaid for individ-
uals 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 devel-
oped and implemented by State Medicaid programs
or other entities to identify and enroll eligible indi-
viduals with substance use disorders who are experi-
encing or at risk of experiencing homelessness in 
State Medicaid programs. 
SEC. 1018. TECHNICAL ASSISTANCE AND SUPPORT FOR IN-
NOVATIVE STATE STRATEGIES TO PROVIDE 
HOUSING-RELATED SUPPORTS UNDER MED-
ICAID. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall provide technical assistance and sup-
port to States regarding the development and expansion of 
innovative State strategies (including through State Med-
icaid 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 re-
quirements of subsection (a).
TITLE 
II—MEDICARE 
PROVI-
SIONS 
TO 
ADDRESS 
THE 
OPIOID CRISIS 
SEC. 2001. EXPANDING THE USE OF TELEHEALTH SERVICES 
FOR THE TREATMENT OF OPIOID USE DIS-
ORDER AND OTHER SUBSTANCE USE DIS-
ORDERS. 
(a) IN GENERAL.—Section 1834(m) of the Social Secu-
rity 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 in-
serting ‘‘clause (ii) and paragraph (6)(C)’’; and 
(B) in clause (ii), in the heading, by strik-
ing ‘‘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 tele-
health services described in paragraph (7)’’ be-
fore the period at the end; and 
(3) by adding at the end the following new para-
graph:
‘‘(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 eli-
gible telehealth individual with a substance use dis-
order diagnosis for purposes of treatment of such dis-
order or co-occurring mental health disorder, as deter-
mined by the Secretary, at an originating site de-
scribed in paragraph (4)(C)(ii) (other than an origi-
nating site described in subclause (IX) of such para-
graph).’’. 
(b) IMPLEMENTATION.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’) may implement the amendments made by this sec-
tion 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 sec-
tion 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 avail-
able, 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 Manage-
ment Account to remain available until expended. 
SEC. 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 para-
graph: 
‘‘(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 sub-
paragraph (I); and
(2) by inserting after subparagraph (F) the fol-
lowing new subparagraphs: 
‘‘(G) Screening for potential substance use 
disorders and referral for treatment as appro-
priate. 
‘‘(H) The furnishing of a review of any cur-
rent opioid prescriptions (as defined in sub-
section (ww)(4)).’’. 
(c) RULE OF CONSTRUCTION.—Nothing in the amend-
ments 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 in-
dividual 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. 
SEC. 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 add-
ing at the end the following: 
‘‘(7) REQUIREMENT OF E-PRESCRIBING FOR CON-
TROLLED SUBSTANCES.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (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 accord-
ance with an electronic prescription drug pro-
gram that meets the requirements of paragraph 
(2). 
‘‘(B) 
EXCEPTION
FOR
CERTAIN
CIR-
CUMSTANCES.—The Secretary shall, through 
rulemaking, specify circumstances and processes 
by which the Secretary may waive the require-
ment 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 Na-
tional Council for Prescription Drug Pro-
grams SCRIPT Standard; 
‘‘(iii) a prescription issued by a prac-
titioner 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 pre-
scribing due to demonstrated economic 
hardship, technological limitations that are 
not reasonably within the control of the 
practitioner, 
or 
other 
exceptional 
cir-
cumstance demonstrated by the practitioner; 
‘‘(iv) a prescription issued by a practi-
tioner under circumstances in which, not-
withstanding the practitioner’s ability to 
submit a prescription electronically as re-
quired by this subsection, such practitioner 
reasonably determines that it would be im-
practical for the individual involved to ob-
tain substances prescribed by electronic pre-
scription in a timely manner, and such 
delay would adversely impact the individ-
ual’s medical condition involved; 
‘‘(v) a prescription issued by a practi-
tioner prescribing a drug under a research 
protocol; 
‘‘(vi) a prescription issued by a practi-
tioner for a drug for which the Food and 
Drug Administration requires a prescrip-
tion to contain elements that are not able to 
be included in electronic prescribing, such
as a drug with risk evaluation and mitiga-
tion strategies that include elements to as-
sure safe use; 
‘‘(vii) a prescription issued by a prac-
titioner— 
‘‘(I) for an individual who re-
ceives 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 prac-
titioner for an individual who is— 
‘‘(I) a resident of a nursing facil-
ity (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 other-
wise 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 indi-
vidual who is being prescribed a covered part D 
drug to designate a particular pharmacy to dis-
pense the covered part D drug to the extent con-
sistent 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-com-
pliance with the requirement under subpara-
graph (A).’’. 
(b) EFFECTIVE DATE.—The amendment made by sub-
section (a) shall apply to coverage of drugs prescribed on 
or after January 1, 2021. 
(c) UPDATE OF BIOMETRIC COMPONENT OF MULTI-
FACTOR 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 pre-
scriptions of controlled substances. 
SEC. 2004. REQUIRING PRESCRIPTION DRUG PLAN SPON-
SORS 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 subpara-
graph (E) the following new subparagraph: 
‘‘(F) With respect to plan years beginning 
on or after January 1, 2022, a drug manage-
ment 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’’. 
SEC. 2005. MEDICARE COVERAGE OF CERTAIN SERVICES 
FURNISHED BY OPIOID TREATMENT PRO-
GRAMS. 
(a) COVERAGE.—Section 1861(s)(2) of the Social Secu-
rity 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 sub-
paragraph: 
‘‘(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 SERV-
ICES.—The term ‘opioid use disorder treatment serv-
ices’ 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 treat-
ment 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 profes-
sional 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 Sec-
retary 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 Sub-
stance Abuse and Mental Health Services Ad-
ministration 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 individ-
uals being furnished services under such 
program; and 
‘‘(ii) the effective and efficient fur-
nishing of such services.’’. 
(c) PAYMENT.— 
(1) IN GENERAL.—Section 1833(a)(1) of the So-
cial Security Act (42 U.S.C. 1395l(a)(1)) is amend-
ed— 
(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 speci-
fied by the Secretary’’. 
(2) PAYMENT DETERMINATION.—Section 1834 of 
the Social Security Act (42 U.S.C. 1395m) is amend-
ed by adding at the end the following new subsection: 
‘‘(w) OPIOID USE DISORDER TREATMENT SERV-
ICES.— 
‘‘(1) IN GENERAL.—The Secretary shall pay to 
an opioid treatment program (as defined in para-
graph (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 de-
fined in paragraph (1) of such section) that are fur-
nished by such program to an individual during an 
episode of care (as defined by the Secretary) begin-
ning 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 im-
plement this subsection through one or more bundles 
based on the type of medication provided (such as 
buprenorphine, methadone, naltrexone, or a new inno-
vative drug), the frequency of services, the scope of 
services furnished, characteristics of the individuals 
furnished such services, or other factors as the Sec-
retary 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 Se-
curity 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 para-
graph: 
‘‘(3) opioid treatment programs (as defined in 
paragraph (2) of section 1861(jjj)), but only with re-
spect to the furnishing of opioid use disorder treat-
ment services (as defined in paragraph (1) of such 
section).’’. 
SEC. 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 sub-
clause (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
OVER-
DOSE.— 
‘‘(I) 
IN
GENERAL.—For 
plan 
years beginning not later than Janu-
ary 1, 2021, a part D eligible indi-
vidual who is not an exempted indi-
vidual described in clause (ii) and who 
is identified under this clause as a 
part D eligible individual with a his-
tory of opioid-related overdose (as de-
fined by the Secretary) shall be in-
cluded as a potentially at-risk bene-
ficiary for prescription drug abuse 
under the drug management program 
under this paragraph. 
‘‘(II) IDENTIFICATION
AND
NO-
TICE.—For purposes of this clause, the 
Secretary shall— 
‘‘(aa) identify part D eligible 
individuals with a history of 
opioid-related overdose (as so de-
fined); and
‘‘(bb) notify the PDP sponsor 
of the prescription drug plan in 
which such an individual is en-
rolled of such identification.’’. 
SEC. 2007. AUTOMATIC ESCALATION TO EXTERNAL REVIEW 
UNDER A MEDICARE PART D DRUG MANAGE-
MENT 
PROGRAM 
FOR 
AT-RISK 
BENE-
FICIARIES. 
(a) IN GENERAL.—Section 1860D–4(c)(5) of the So-
cial Security Act (42 U.S.C. 1395ww–10(c)(5)) is amend-
ed— 
(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 in-
serting ‘‘, 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 Sec-
retary for review and resolution’’; and 
(2) in subparagraph (E), by striking ‘‘and the 
option’’ and all that follows and inserting the fol-
lowing: ‘‘and if on reconsideration a PDP sponsor af-
firms its denial, in whole or in part, the case shall 
be automatically forwarded to the independent, out-
side entity contracted with the Secretary for review 
and resolution.’’. 
(b) EFFECTIVE DATE.—The amendments made by sub-
section (a) shall apply beginning not later January 1, 2021. 
SEC. 2008. SUSPENSION OF PAYMENTS BY MEDICARE PRE-
SCRIPTION DRUG PLANS AND MA–PD PLANS 
PENDING INVESTIGATIONS OF CREDIBLE AL-
LEGATIONS 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 add-
ing at the end the following new paragraph: 
‘‘(7) SUSPENSION OF PAYMENTS PENDING INVES-
TIGATION 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 re-
spect to the Secretary, a provider of services or 
supplier, and payments to such provider of serv-
ices or supplier under this title. A PDP sponsor 
shall notify the Secretary regarding the imposi-
tion of any payment suspension pursuant to the 
previous sentence, such as through the secure
internet website portal (or other successor tech-
nology) 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 ap-
plied pursuant to section 1857(f)(3)(D)),’’ after ‘‘this sub-
section’’. 
(d) CLARIFICATION RELATING TO CREDIBLE ALLEGA-
TION 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 car-
rying out this subsection, section 1860D–12(b)(7) (in-
cluding as applied pursuant to section 1857(f)(3)(D)), 
and section 1903(i)(2)(C), a fraud hotline tip (as de-
fined by the Secretary) without further evidence shall 
not be treated as sufficient evidence for a credible alle-
gation 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. 
TITLE 
III—FDA 
AND 
CON-
TROLLED SUBSTANCE PROVI-
SIONS 
Subtitle A—FDA Provisions 
CHAPTER 1—IN GENERAL 
SEC. 3001. CLARIFYING FDA REGULATION OF NON-ADDICT-
IVE 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 ‘‘Sec-
retary’’), acting through the Commissioner of Food and 
Drugs, shall hold not less than one public meeting to ad-
dress the challenges and barriers of developing non-addict-
ive medical products intended to treat acute or chronic pain 
or addiction, which may include— 
(1) the manner by which the Secretary may in-
corporate 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 develop-
ment of opioid-sparing data for inclusion in the label-
ing 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 informa-
tion 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 ad-
diction; 
(B) considers the risk of addiction of con-
trolled 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 dis-
ease, and the manner in which sponsors may use sur-
rogate endpoints, intermediate endpoints, and real 
world evidence; 
(3) the manner in which the Food and Drug Ad-
ministration will assess evidence to support the inclu-
sion of opioid-sparing data in the labeling of non-ad-
dictive medical products intended to treat acute or 
chronic pain, including— 
(A) alternative data collection methodolo-
gies, including the use of novel clinical trial de-
signs (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 sub-
jects 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, sec-
ondary, and surrogate endpoints, to evaluate the 
reduction of opioid use; 
(D) best practices for communication be-
tween sponsors and the agency on the develop-
ment of data collection methods, including the 
initiation of data collection; and 
(E) the appropriate format in which to sub-
mit 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 mak-
ing 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—
100 
(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))), bio-
logical product (as defined in section 351(i) of the 
Public Health Service Act (42 U.S.C. 262(i))), or de-
vice (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 con-
trolled substances intended to treat acute or chronic 
pain. 
SEC. 3002. EVIDENCE-BASED OPIOID ANALGESIC PRE-
SCRIBING GUIDELINES AND REPORT. 
(a) GUIDELINES.—The Commissioner of Food and 
Drugs shall develop evidence-based opioid analgesic pre-
scribing 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 special-
101 
ties including pain medicine specialty societies, pa-
tient groups, pharmacists, academic or medical re-
search 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 guide-
lines under subsection (a) are finalized, the Commissioner 
of Food and Drugs shall submit to the Committee on En-
ergy 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 sub-
section (a) to protect the public health and a description 
of the public health need with respect to each such indica-
tion-specific treatment guideline.
102 
(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 sub-
section (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 guide-
lines and other recommendations developed under this sec-
tion are accompanied by a clear statement that such guide-
lines or recommendations, as applicable— 
(1) are intended to help inform clinical decision-
making 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.
103 
CHAPTER 2—STOP COUNTERFEIT DRUGS 
BY REGULATING AND ENHANCING EN-
FORCEMENT NOW 
SEC. 3011. SHORT TITLE. 
This chapter may be cited as the ‘‘Stop Counterfeit 
Drugs by Regulating and Enhancing Enforcement Now 
Act’’ or the ‘‘SCREEN Act’’. 
SEC. 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 fol-
lowing: 
‘‘SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RE-
CALL 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 sub-
stance would cause serious adverse health con-
104 
sequences or death, the Secretary may, after providing 
the appropriate person with an opportunity to con-
sult with the agency, issue an order requiring manu-
facturers, 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 re-
quired by such amended order pursuant to subpara-
graph (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 deter-
mines 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
105 
‘‘(C) amend the order to require a recall of 
the controlled substance, including any require-
ments 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 deter-
mines 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 con-
trolled 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 Sec-
retary 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
106 
for, or an order to cease distribution of, such controlled sub-
stance, as applicable, under this section to appropriate per-
sons, including persons who manufacture, distribute, im-
port, 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 sub-
section (a)(3) shall be ordered by the Secretary or an official 
designated by the Secretary. An official may not be so des-
ignated under this section unless the official is the Director 
of the Center for Drug Evaluation and Research or an offi-
cial senior to such Director. 
‘‘(d) SAVINGS CLAUSE.—Nothing contained in this sec-
tion 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
RE-
FUSAL.—The third sentence of section 801(a) of the Federal
107 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amend-
ed 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 sub-
sections (a) and (b), shall be effective beginning on the date 
of enactment of this Act. 
SEC. 3013. SINGLE SOURCE PATTERN OF IMPORTED ILLE-
GAL 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 import-
ing or offering for import controlled substances or drugs as 
described in section 306(b)(3)(D), and such pattern is iden-
tified 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.’’.
108 
SEC. 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 ‘‘Sec-
retary’’), acting through the Commissioner of Food and 
Drugs, shall coordinate with the Secretary of Homeland Se-
curity 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 improve-
ments to such facilities, technologies, and inspection capac-
ity. 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 CAPAC-
ITY.— 
(1) IN GENERAL.—In carrying out this section, 
the Secretary shall, in collaboration with the Sec-
retary 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 re-
lated to drug imports within the international mail 
facilities include—
109 
(A) facility upgrades and improved capac-
ity 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 destruc-
tion; 
(iii) the construction of, or upgrades 
to, laboratory capacity for purposes of de-
tection and testing of imported goods; 
(iv) upgrades to the security of import 
facilities; and 
(v) innovative technology and equip-
ment 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
110 
(B) innovative technology, including con-
trolled substance detection and testing equipment 
and other applicable technology, in order to col-
laborate with the U.S. Customs and Border Pro-
tection to share near-real-time information, in-
cluding information about test results, as appro-
priate. 
(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 appro-
priate 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 Com-
mittee on Homeland Security of the House of Representa-
tives 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 to-
ward near-real-time information sharing and the interoper-
ability of such technologies.
111 
CHAPTER 3—STOP ILLICIT DRUG 
IMPORTATION 
SEC. 3021. SHORT TITLE. 
This chapter may be cited as the ‘‘Stop Illicit Drug 
Importation Act of 2018’’. 
SEC. 3022. RESTRICTING ENTRANCE OF ILLICIT DRUGS. 
(a) FOOD AND DRUG ADMINISTRATION AND U.S. CUS-
TOMS 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 pe-
riodically update a mutually agreed upon list of the 
controlled substances that the Secretary will refer to 
U.S. Customs and Border Protection, unless the Sec-
retary and U.S. Customs and Border Protection agree 
otherwise, when such substances are offered for import 
via international mail and appear to violate the Con-
trolled 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 Cos-
metic Act (21 U.S.C. 301 et seq.), or any other appli-
cable law. The Secretary shall transfer controlled sub-
stances on such list to the U.S. Customs and Border
112 
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 Secu-
rity, shall report to the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate on the implementation of this sec-
tion. 
(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
113 
(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 subpara-
graph (A), by inserting ‘‘or (3)’’ after 
‘‘paragraph (2)’’; 
(ii) in subparagraph (A), by striking 
the comma at the end and inserting a semi-
colon; 
(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;
114 
(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 fel-
ony for conduct relating to the importation into 
the United States of any drug or controlled sub-
stance (as defined in section 102 of the Con-
trolled Substances Act); 
‘‘(D) the person has engaged in a pattern of 
importing or offering for import— 
‘‘(i) controlled substances that are pro-
hibited 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 author-
ized 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 Sec-
retary.’’; and
115 
(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 in-
consistent with personal or household use by the im-
porter.’’. 
(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 re-
fused 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 admis-
sion’’; 
(2) by inserting ‘‘If it appears from the exam-
ination of such samples or otherwise that the article 
is a counterfeit drug, such article shall be refused ad-
mission.’’ 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
116 
(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 Con-
trolled 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 PHARMA-
CEUTICAL 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 Sec-
retary as a drug if the article— 
‘‘(A) is not— 
‘‘(i) accompanied by an electronic im-
port 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 signifi-
cant public health concern and is, or contains—
117 
‘‘(i) an active ingredient in a drug— 
‘‘(I) that is approved under sec-
tion 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 con-
strued 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 para-
graph (1).’’.
118 
CHAPTER 4—SECURING OPIOIDS AND UN-
USED NARCOTICS WITH DELIBERATE 
DISPOSAL AND PACKAGING 
SEC. 3031. SHORT TITLE. 
This chapter may be cited as the ‘‘Securing Opioids 
and Unused Narcotics with Deliberate Disposal and Pack-
aging Act of 2018’’ or the ‘‘SOUND Disposal and Pack-
aging Act’’. 
SEC. 3032. SAFETY-ENHANCING PACKAGING AND DISPOSAL 
FEATURES. 
(a) DELIBERATE DISPOSAL
AND PACKAGING ELE-
MENTS 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 fac-
tors described in subparagraphs (C) and (D) of sub-
section (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 dis-
pensing to certain patients in unit dose pack-
119 
aging, packaging that provides a set duration, or 
another packaging system that the Secretary de-
termines may mitigate such serious risk; or 
‘‘(B) the drug be dispensed to certain pa-
tients with a safe disposal packaging or safe dis-
posal 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 Cos-
metic 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 limita-
tions; and’’. 
(c) APPLICATION TO ABBREVIATED NEW DRUG APPLI-
CATIONS.—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)—
120 
(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 appli-
cable 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 ap-
plicable 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—
121 
(1) a description of available evidence, if any, on 
the effectiveness of site-of-use, in-home controlled sub-
stance 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 or-
ganization, and how such standards should be consid-
ered 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 dis-
posal products, including— 
(A) identification of the Federal agencies 
that oversee such products;
122 
(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 rec-
ommended by such agencies, including unit dose 
packaging, packaging that provides a set dura-
tion, 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 tech-
nologies require Federal oversight and, if so, 
which agency or agencies should be responsible
123 
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 effective-
ness of such products. 
CHAPTER 5—POSTAPPROVAL STUDY 
REQUIREMENTS 
SEC. 3041. CLARIFYING FDA POSTMARKET AUTHORITIES. 
(a) DEFINITION OF ADVERSE DRUG EXPERIENCE.— 
Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355–1(b)(1)(E)) is amended by strik-
ing ‘‘of the drug’’ and inserting ‘‘of the drug, which may 
include reduced effectiveness under the conditions of use pre-
scribed 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 IN-
FORMATION’’; and 
(B) by striking ‘‘If the Secretary becomes’’ 
and all that follows through ‘‘in the labeling of
124 
the drug’’ and inserting ‘‘If the Secretary be-
comes aware of new information, including any 
new safety information or information related to 
reduced effectiveness, that the Secretary deter-
mines should be included in the labeling of the 
drug’’; 
(2) in clause (i) of subparagraph (B), by insert-
ing before the semicolon ‘‘, or new effectiveness infor-
mation’’; 
(3) in subparagraph (C) by striking ‘‘safety in-
formation’’ and inserting ‘‘safety or new effectiveness 
information’’; and 
(4) in subparagraph (E) by striking ‘‘safety in-
formation’’ 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 cir-
cumstances under which the Food and Drug Administra-
tion may require postmarket studies or clinical trials to as-
sess 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 Admin-
istration may apply this section and the amendments made
125 
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. 
Subtitle B—Controlled Substance 
Provisions 
CHAPTER 1—MORE FLEXIBILITY WITH RE-
SPECT 
TO 
MEDICATION-ASSISTED 
TREATMENT FOR OPIOID USE DIS-
ORDERS 
SEC. 3201. ALLOWING FOR MORE FLEXIBILITY WITH RE-
SPECT 
TO 
MEDICATION-ASSISTED 
TREAT-
MENT 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 fol-
lows: 
‘‘(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;
126 
‘‘(bb) 100 if the practitioner holds addi-
tional credentialing, as defined in section 8.2 of 
title 42, Code of Federal Regulations (or suc-
cessor regulations); 
‘‘(cc) 100 if the practitioner provides medi-
cation-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 regula-
tions)); or 
‘‘(dd) 275 if the practitioner meets the re-
quirements 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 fol-
lows:
127 
‘‘(II) a qualifying other practitioner, as de-
fined in clause (iv), who is a nurse practitioner 
or physician assistant; or’’. 
(c) IMPOSING
A TIME LIMITATION
FOR CLINICAL 
NURSE SPECIALISTS, CERTIFIED REGISTERED NURSE AN-
ESTHETISTS, AND CERTIFIED NURSE MIDWIFES TO BE-
COME 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 quali-
fying 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 PRACTI-
TIONER.—Section 303(g)(2)(G)(iv) of the Controlled Sub-
stances 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, cer-
tified 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
128 
of Health and Human Services, in consultation with the 
Drug Enforcement Administration, shall submit to Con-
gress 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 Sec-
retary shall study, with respect to opioid use disorder treat-
ment— 
(1) the average frequency with which qualifying 
practitioners see their patients; 
(2) the average frequency with which patients re-
ceive counseling, including the rates by which such 
counseling is provided by such a qualifying practi-
tioner 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
129 
(7) any available information regarding the di-
version of drugs by patients receiving such treatment 
from such a qualifying practitioner. 
SEC. 3202. MEDICATION-ASSISTED TREATMENT FOR RECOV-
ERY FROM SUBSTANCE USE DISORDER. 
(a) WAIVERS FOR MAINTENANCE TREATMENT OR DE-
TOXIFICATION.—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 stand-
ing 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 writ-
ten notification under subparagraph (B) and success-
fully completed a comprehensive allopathic or osteo-
pathic medicine curriculum or accredited medical 
residency that— 
‘‘(aa) included not less than 8 hours of 
training on treating and managing opioid-de-
pendent patients; and 
‘‘(bb) included, at a minimum— 
‘‘(AA) the training described in items 
(aa) through (gg) of subclause (IV); and
130 
‘‘(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 de-
fined 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 ado-
lescents, are granted a waiver under such section 303(g)(2) 
to treat children and adolescents with substance use dis-
orders. 
(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 insert-
ing ‘‘Health and Human Services’’. 
SEC. 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
131 
hospitals located in the United States to support the devel-
opment of curricula that meet the requirements under sub-
clause (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. 
SEC. 3204. DELIVERY OF A CONTROLLED SUBSTANCE BY A 
PHARMACY TO BE ADMINISTERED BY INJEC-
TION OR IMPLANTATION. 
(a) IN GENERAL.—The Controlled Substances Act is 
amended by inserting after section 309 (21 U.S.C. 829) the 
following: 
‘‘DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY 
TO AN ADMINISTERING PRACTITIONER 
‘‘SEC. 309A. (a) IN GENERAL.—Notwithstanding sec-
tion 102(10), a pharmacy may deliver a controlled sub-
stance 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 pur-
pose of administering the controlled substance by the practi-
tioner if— 
‘‘(1) the controlled substance is delivered by the 
pharmacy to the prescribing practitioner or the prac-
titioner administering the controlled substance, as ap-
132 
plicable, at the location listed on the practitioner’s 
certificate of registration issued under this title; 
‘‘(2) the controlled substance is to be adminis-
tered for the purpose of maintenance or detoxification 
treatment under section 303(g)(2) and— 
‘‘(A) the practitioner who issued the pre-
scription is a qualifying practitioner authorized 
under, and acting within the scope of that sec-
tion; and 
‘‘(B) the controlled substance is to be ad-
ministered by injection or implantation; 
‘‘(3) the pharmacy and the practitioner are au-
thorized to conduct the activities specified in this sec-
tion under the law of the State in which such activi-
ties 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 sub-
stance by the practitioner; and 
‘‘(6) notwithstanding any exceptions under sec-
tion 307, the prescribing practitioner, and the practi-
133 
tioner administering the controlled substance, as ap-
plicable, maintain complete and accurate records of 
all controlled substances delivered, received, adminis-
tered, or otherwise disposed of under this section, in-
cluding 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 ADMINIS-
TERED.— 
‘‘(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 de-
scribed 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 RE-
PORT.—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).
134 
‘‘(3) MINIMUM NUMBER OF DAYS.—Any modi-
fication 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 Gen-
eral 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 im-
plantation. 
(c) TECHNICAL AND CONFORMING AMENDMENT.—The 
table of contents for the Comprehensive Drug Abuse Preven-
tion 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 admin-
istering practitioner.’’. 
CHAPTER 2—EMPOWERING PHARMACISTS 
IN THE FIGHT AGAINST OPIOID ABUSE 
SEC. 3211. SHORT TITLE. 
This chapter may be cited as the ‘‘Empowering Phar-
macists in the Fight Against Opioid Abuse Act’’. 
SEC. 3212. PROGRAMS AND MATERIALS FOR TRAINING ON 
CERTAIN CIRCUMSTANCES UNDER WHICH A 
PHARMACIST MAY DECLINE TO FILL A PRE-
SCRIPTION. 
(a) IN GENERAL.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and
135 
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 ap-
propriate, 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 there-
under, 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 de-
clining to fill a prescription under such cir-
cumstances, 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 pre-
scription and actions to take after declining to fill a 
prescription; and
136 
(2) other health care practitioners and the public 
on a pharmacist’s ability to decline to fill prescrip-
tions in certain circumstances and a description of 
those circumstances (as described in the materials de-
veloped under subsection (a)(1)). 
(c) STAKEHOLDER INPUT.—In developing the pro-
grams and materials required under subsection (a), the Sec-
retary 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. 
CHAPTER 3—SAFE DISPOSAL OF UNUSED 
MEDICATION 
SEC. 3221. SHORT TITLE. 
This chapter may be cited as the ‘‘Safe Disposal of 
Unused Medication Act’’. 
SEC. 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
137 
the scope of employment, may handle, without being reg-
istered 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 appli-
cable Federal, State, Tribal, and local law and— 
‘‘(i) the disposal occurs after the death of a per-
son receiving hospice care; 
‘‘(ii) the controlled substance is expired; or 
‘‘(iii)(I) the employee is— 
‘‘(aa) the physician of the person re-
ceiving 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 pro-
gram’ have the meanings given to those terms in sec-
tion 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—
138 
‘‘(I) is employed by, or pursuant to ar-
rangements made by, a qualified hospice pro-
gram; 
‘‘(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 em-
ployment 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 respon-
sible 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 sub-
stances of a person receiving hospice care after 
the person’s death; 
‘‘(II) at the time when the controlled sub-
stances are first ordered— 
‘‘(aa) provides a copy of the written 
policies and procedures to the patient or pa-
tient representative and family;
139 
‘‘(bb) discusses the policies and proce-
dures 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 clin-
ical 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 clin-
ical record the type of controlled substance, 
dosage, route of administration, and quan-
tity 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 para-
graph (5).
140 
(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 con-
trolled substances in hospice care or hospice programs. 
SEC. 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 dis-
posal of controlled substances in the home of an indi-
vidual. 
(2) CONTENTS.—In conducting the study under 
paragraph (1), the Comptroller General shall in-
clude— 
(A) an overview of any challenges encoun-
tered 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 dis-
posal of controlled substances over time; and
141 
(B) a description of Federal requirements, 
including requirements under the Medicare pro-
gram, for hospice programs regarding the dis-
posal of controlled substances in a home setting, 
and oversight of compliance with those require-
ments. 
(b) REPORT.—Not later than 18 months after the date 
of enactment of this Act, the Comptroller General shall sub-
mit to Congress a report containing the results of the study 
conducted under subsection (a), together with recommenda-
tions, if any, for such legislation and administrative action 
as the Comptroller General determines appropriate. 
CHAPTER 4—SPECIAL REGISTRATION FOR 
TELEMEDICINE CLARIFICATION 
SEC. 3231. SHORT TITLE. 
This chapter may be cited as the ‘‘Special Registration 
for Telemedicine Clarification Act of 2018’’. 
SEC. 3232. REGULATIONS RELATING TO A SPECIAL REG-
ISTRATION 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 Sec-
142 
retary, 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.’’. 
CHAPTER 5—SYNTHETIC ABUSE AND 
LABELING OF TOXIC SUBSTANCES 
SEC. 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 con-
trolled substance analogue was intended for human con-
sumption 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 sub-
stance for the marketed, advertised, or labeled pur-
pose.
143 
‘‘(3) The difference between the price at which 
the substance is sold and the price at which the sub-
stance it is purported to be or advertised as is nor-
mally sold. 
‘‘(4) The diversion of the substance from legiti-
mate channels and the clandestine importation, man-
ufacture, 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 imme-
diate means. 
‘‘(6) Any controlled substance analogue that is 
manufactured, formulated, sold, distributed, or mar-
keted with the intent to avoid the provisions of exist-
ing drug laws. 
‘‘(c) LIMITATION.—For purposes of this section, evi-
dence that a substance was not marketed, advertised, or la-
beled for human consumption, by itself, shall not be suffi-
cient to establish that the substance was not intended for 
human consumption.’’. 
CHAPTER 6—ACCESS TO INCREASED 
DRUG DISPOSAL 
SEC. 3251. SHORT TITLE. 
This chapter may be cited as the ‘‘Access to Increased 
Drug Disposal Act of 2018’’.
144 
SEC. 3252. DEFINITIONS. 
In this chapter— 
(1) the term ‘‘Attorney General’’ means the At-
torney General, acting through the Assistant Attorney 
General for the Office of Justice Programs; 
(2) the term ‘‘authorized collector’’ means a nar-
cotic treatment program, a hospital or clinic with an 
on-site pharmacy, a retail pharmacy, or a reverse dis-
tributor, that is authorized as a collector under sec-
tion 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. 
SEC. 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. 
SEC. 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 over-
sees pharmaceutical care and will be responsible for 
complying with the requirements of the grant;
145 
(2) details a plan to increase participation rates 
of eligible collectors as authorized collectors; and 
(3) describes how the State will select eligible col-
lectors to be served under the grant. 
SEC. 3255. USE OF GRANT FUNDS. 
A State that receives a covered grant, and any sub-
recipient 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. 
SEC. 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. 
SEC. 3257. DURATION OF GRANTS. 
The Attorney General shall determine the period of 
years for which a covered grant is made to a State. 
SEC. 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—
146 
(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. 
SEC. 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. 
SEC. 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. 
CHAPTER 7—USING DATA TO PREVENT 
OPIOID DIVERSION 
SEC. 3271. SHORT TITLE. 
This chapter may be cited as the ‘‘Using Data To Pre-
vent Opioid Diversion Act of 2018’’. 
SEC. 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
147 
and Consolidated Orders System to help drug manufactur-
ers 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 reg-
istrant from the responsibility of the manufacturer, dis-
tributor, 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 Sub-
stances Act (21 U.S.C. 823) or any successor law or 
associated regulation. 
SEC. 3273. AMENDMENTS. 
(a) RECORDS AND REPORTS OF REGISTRANTS.—Sec-
tion 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
148 
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 dis-
tributed, listed by Administration Controlled Sub-
stances Code Number, to each pharmacy and practi-
tioner 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 dis-
tributor 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 there-
under, the Attorney General may take into account that the
149 
information made available under this subsection was 
available to the registrant.’’; and 
(3) by inserting after subsection (i), as so redes-
ignated, 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, licens-
ing, 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 Consoli-
dated 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 con-
tained in schedule II, which, in the discretion of the Attor-
ney General, are determined to have the highest abuse. 
‘‘(2) If the Attorney General publishes the report de-
scribed 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
150 
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 amend-
ed— 
(1) in subsection (a)— 
(A) in paragraph (15), by striking ‘‘or’’ at 
the end; 
(B) in paragraph (16), by striking the pe-
riod 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 subpara-
graph (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.
151 
‘‘(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 diver-
sion of opioids, or failing to review the most recent informa-
tion 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 subpara-
graph (A) that was a violation of paragraph (5), (10), or 
(17) of subsection (a) committed by a registered manufac-
turer 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.’’. 
SEC. 3274. REPORT. 
Not later than 1 year after the date of enactment of 
this Act, the Attorney General shall submit to Congress a
152 
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 indi-
vidual order rises to the level of a suspicious order to a 
given distributor. 
CHAPTER 8—OPIOID QUOTA REFORM 
SEC. 3281. SHORT TITLE. 
This chapter may be cited as the ‘‘Opioid Quota Re-
form Act’’. 
SEC. 3282. STRENGTHENING CONSIDERATIONS FOR DEA 
OPIOID QUOTAS. 
(a) IN GENERAL.—Section 306 of the Controlled Sub-
stances 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 Gen-
eral determines it will assist in avoiding the overproduc-
tion, shortages, or diversion of a controlled substance, estab-
153 
lish an aggregate or individual production quota under this 
subsection, or a procurement quota established by the Attor-
ney General by regulation, in terms of pharmaceutical dos-
age forms prepared from or containing the controlled sub-
stance.’’; 
(2) in subsection (b), in the first sentence, by 
striking ‘‘production’’ and inserting ‘‘manufac-
turing’’; 
(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 sec-
tion, or any procurement quota established by the Attorney 
General 
by 
regulation, 
for 
fentanyl, 
oxycodone, 
hydrocodone, oxymorphone, or hydromorphone (in this sub-
section 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 Gen-
eral, in consultation with the Secretary of Health and 
Human Services, determines reliable on rates of over-
dose deaths and abuse and overall public health im-
154 
pact related to the covered controlled substance in the 
United States; and 
‘‘(ii) may take into consideration whatever other 
sources of information the Attorney General deter-
mines reliable. 
‘‘(C) After estimating the amount of diversion of a cov-
ered controlled substance, the Attorney General shall make 
appropriate quota reductions, as determined by the Attor-
ney General, from the quota the Attorney General would 
have otherwise established had such diversion not been con-
sidered. 
‘‘(2)(A) For any year for which the approved aggregate 
production quota for a covered controlled substance is high-
er than the approved aggregate production quota for the 
covered controlled substance for the previous year, the Attor-
ney 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 avail-
able 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,
155 
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 manufac-
turing 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 Con-
gress 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 ac-
cepted medical use of the covered controlled sub-
stances; and 
‘‘(B) work with the Secretary of Health and 
Human Services on methods to appropriately and 
anonymously estimate the type and amount of cov-
ered controlled substances that are submitted for col-
156 
lection from approved drug collection receptacles, 
mail-back programs, and take-back events.’’. 
(b) CONFORMING CHANGE.—The Law Revision Coun-
sel is directed to amend the heading for subsection (b) of 
section 826 of title 21, United States Code, by striking 
‘‘PRODUCTION’’ and inserting ‘‘MANUFACTURING’’. 
CHAPTER 9—PREVENTING DRUG 
DIVERSION 
SEC. 3291. SHORT TITLE. 
This chapter may be cited as the ‘‘Preventing Drug 
Diversion Act of 2018’’. 
SEC. 3292. IMPROVEMENTS TO PREVENT DRUG DIVERSION. 
(a) DEFINITION.—Section 102 of the Controlled Sub-
stances 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 de-
viating substantially from a normal pattern; 
and 
‘‘(C) orders of controlled substances of un-
usual frequency.’’.
157 
(b) SUSPICIOUS ORDERS.—Part C of the Controlled 
Substances Act (21 U.S.C. 821 et seq.) is amended by add-
ing at the end the following: 
‘‘SEC. 312. SUSPICIOUS ORDERS. 
‘‘(a) REPORTING.—Each registrant shall— 
‘‘(1) design and operate a system to identify sus-
picious orders for the registrant; 
‘‘(2) ensure that the system designed and oper-
ated under paragraph (1) by the registrant complies 
with applicable Federal and State privacy laws; and 
‘‘(3) upon discovering a suspicious order or se-
ries of orders, notify the Administrator of the Drug 
Enforcement Administration and the Special Agent 
in Charge of the Division Office of the Drug Enforce-
ment Administration for the area in which the reg-
istrant 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 col-
lecting reports of suspicious orders. 
‘‘(2) SATISFACTION
OF
REPORTING
REQUIRE-
MENTS.—If a registrant reports a suspicious order to 
the centralized database established under paragraph 
(1), the registrant shall be considered to have com-
158 
plied 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 Adminis-
tration 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 pro-
vide 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 infor-
mation, as permitted under State law, possessed by
159 
the States relating to prescriptions for controlled sub-
stances 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 re-
porting 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 col-
lect 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
160 
actions were taken in response to the reports; 
and 
(D) descriptions of the data analyses con-
ducted 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 an-
nually thereafter until the date that is 5 years after 
the date of enactment of this Act, the Attorney Gen-
eral shall submit to Congress a report providing, for 
the previous year— 
(A) the number of reports of suspicious or-
ders; 
(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 consulta-
tion 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
161 
potential suspicious orders of opioids on a national 
level using computerized algorithms, including the ex-
tent to which such algorithms— 
(A) would help ensure that potentially sus-
picious orders are more accurately captured, 
identified, and reported in real time to suppliers 
before orders are filled; 
(B) may produce false positives of sus-
picious 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 sus-
picious orders of opioids. 
TITLE IV—OFFSETS 
SEC. 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 fur-
ther amended by adding at the end the following new para-
graph: 
‘‘(9)(A) With respect to expenditures described in sub-
paragraph (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 Sec-
162 
retary shall substitute the Federal medical assistance per-
centage 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 pro-
vision of law) for the percentage that applies to such ex-
penditures 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 subpara-
graph (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 suc-
cessor regulation), by electing— 
‘‘(I) in the case of a State described in sub-
paragraph (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
163 
‘‘(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 expendi-
tures as a result of the entity’s failure to meet such 
ratio. 
‘‘(C) For purposes of subparagraph (B), a State de-
scribed 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 pay-
ment for services provided by entities described in such sub-
paragraph under the State plan under this title (or a waiv-
er 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 sec-
tion 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 sec-
tion 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)
164 
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 de-
fined 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 regula-
tion).’’. 
SEC. 4002. REQUIRING REPORTING BY GROUP HEALTH 
PLANS OF PRESCRIPTION DRUG COVERAGE 
INFORMATION FOR PURPOSES OF IDENTI-
FYING PRIMARY PAYER SITUATIONS UNDER 
THE MEDICARE PROGRAM. 
Clause (i) of section 1862(b)(7)(A) of the Social Secu-
rity 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 pro-
gram under this title; or
165 
‘‘(II) for calendar quarters begin-
ning on or after January 1, 2020, a 
primary payer with respect to benefits 
relating to prescription drug coverage 
under part D; and’’. 
SEC. 4003. ADDITIONAL RELIGIOUS EXEMPTION FROM 
HEALTH 
COVERAGE 
RESPONSIBILITY 
RE-
QUIREMENT. 
(a) IN GENERAL.—Section 5000A(d)(2)(A) of the In-
ternal Revenue Code of 1986 is amended to read as follows: 
‘‘(A) 
RELIGIOUS
CONSCIENCE
EXEMP-
TIONS.— 
‘‘(i) IN
GENERAL.—Such term shall 
not include any individual for any month 
if such individual has in effect an exemp-
tion under section 1311(d)(4)(H) of the Pa-
tient Protection and Affordable Care Act 
which certifies that— 
‘‘(I) such individual is a member 
of a recognized religious sect or divi-
sion thereof which is described in sec-
tion 1402(g)(1), and is adherent of es-
tablished tenets or teachings of such 
sect or division as described in such 
section; or
166 
‘‘(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 reli-
gious method of healing, and for whom 
the acceptance of medical health serv-
ices would be inconsistent with the reli-
gious beliefs of the individual. 
‘‘(ii) SPECIAL RULES.— 
‘‘(I) MEDICAL HEALTH SERVICES 
DEFINED.—For purposes of this sub-
paragraph, the term ‘medical health 
services’ does not include routine den-
tal, vision and hearing services, mid-
wifery 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 Serv-
ices may provide in implementing sec-
tion 1311(d)(4)(H) of the Patient Pro-
tection and Affordable Care Act. 
‘‘(II) ATTESTATION REQUIRED.— 
Clause (i)(II) shall apply to an indi-
vidual for months in a taxable year
167 
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 sub-
section (a) shall apply to taxable years beginning after De-
cember 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. 
SEC. 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 appli-
cation’’;
168 
(B) in the paragraph (4) inserted by such 
section 3(1), by inserting ‘‘application’’ before 
‘‘under section 351(k) of the Public Health Serv-
ice Act’’; 
(C) in the paragraph (5) inserted by such 
section 3(1), by striking ‘‘for licensure of a bio-
logical product under section 351(k) of the Pub-
lic 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 li-
censee, 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—
169 
(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 insert-
ing ‘‘OR BIOSIMILAR BIOLOGICAL PRODUCT 
APPLICANT’’ after ‘‘APPLICANT’’; 
(ii) in paragraph (1)(B), by striking 
the first sentence and inserting the fol-
lowing: ‘‘A biosimilar biological product ap-
170 
plicant that has submitted a biosimilar bio-
logical product application that references a 
reference product and another biosimilar bi-
ological product applicant that has sub-
mitted a biosimilar biological product ap-
plication that references the same reference 
product shall each file the agreement in ac-
cordance 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 ap-
plies to the biosimilar biological prod-
uct applications with which the agree-
ment is concerned’’ and inserting ‘‘, an 
agreement between 2 or more bio-
similar 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 bio-
171 
similar biological product, or an agree-
ment between 2 or more biosimilar bio-
logical 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,’’. 
TITLE V—OTHER MEDICAID 
PROVISIONS 
Subtitle A—Mandatory Reporting 
With Respect to Adult Behav-
ioral Health Measures 
SEC. 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 Janu-
ary 1, 2013’’ and inserting the following: 
‘‘(A) VOLUNTARY
REPORTING.—Not later 
than January 1, 2013’’; and 
(ii) by adding at the end the following:
172 
‘‘(B) MANDATORY
REPORTING
WITH
RE-
SPECT
TO
BEHAVIORAL
HEALTH
MEASURES.— 
Beginning with the State report required under 
subsection (d)(1) for 2024, the Secretary shall re-
quire States to use all behavioral health meas-
ures included in the core set of adult health qual-
ity measures and any updates or changes to such 
measures to report information, using the stand-
ardized 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 insert-
ing ‘‘such plan’’; and
173 
(B) by striking ‘‘subsection (a)(5)’’ and in-
serting ‘‘subsection (b)(5) and, beginning with 
the report for 2024, all behavioral health meas-
ures included in the core set of adult health qual-
ity measures maintained under such subsection 
(b)(5) and any updates or changes to such meas-
ures (as required under subsection (b)(3))’’. 
Subtitle B—Medicaid IMD 
Additional Info 
SEC. 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 Ac-
cess are Limited without Information Needed about Facility 
Obligations Act’’ or the ‘‘Medicaid IMD ADDITIONAL 
INFO Act’’. 
SEC. 5012. MACPAC EXPLORATORY STUDY AND REPORT ON 
INSTITUTIONS FOR MENTAL DISEASES RE-
QUIREMENTS AND PRACTICES UNDER MED-
ICAID. 
(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
174 
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 dis-
eases 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 min-
imum— 
(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 institu-
tion; 
(B) the process, including any timeframe, 
used by such institution to clinically assess and 
reassess such individuals; and
175 
(C) the discharge process used by such insti-
tution, 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 institu-
tions, 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 qual-
ity standards, clinical standards, and facility stand-
ards) that such institutions must meet to receive pay-
ment under such State plans (or waivers) and how 
each such State determines if such standards have 
been met. 
(6) If determined appropriate by the Commis-
sion, recommendations for policies and actions by
176 
Congress and the Centers for Medicare & Medicaid 
Services, such as on how State Medicaid programs 
may improve care and improve standards and in-
cluding a recommendation for how the Centers for 
Medicare & Medicaid Services can improve data col-
lection from such programs to address any gaps in 
information. 
(b) STAKEHOLDER INPUT.—In carrying out subsection 
(a), the Medicaid and CHIP Payment and Access Commis-
sion 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 advo-
cates, 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 judg-
ment of the selector. 
(2) STATE.—The term ‘‘State’’ means each of the 
50 States, the District of Columbia, and any com-
monwealth or territory of the United States.
177 
(3) INSTITUTION FOR MENTAL DISEASES.—The 
term ‘‘institution for mental diseases’’ has the mean-
ing given such term in section 435.1010 of title 42, 
Code of Federal Regulations, or any successor regula-
tion. 
Subtitle C—CHIP Mental Health 
and Substance Use Disorder Parity 
SEC. 5021. SHORT TITLE. 
This subtitle may be cited as the ‘‘CHIP Mental 
Health and Substance Use Disorder Parity Act’’. 
SEC. 5022. ENSURING ACCESS TO MENTAL HEALTH AND 
SUBSTANCE USE DISORDER SERVICES FOR 
CHILDREN AND PREGNANT WOMEN UNDER 
THE CHILDREN’S HEALTH INSURANCE PRO-
GRAM. 
(a) IN GENERAL.—Section 2103(c)(1) of the Social Se-
curity 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 dis-
order 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—
178 
(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 fol-
lowing new paragraph: 
‘‘(5) MENTAL HEALTH AND SUBSTANCE USE DIS-
ORDER 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 preg-
nancy-related assistance for targeted low-income preg-
nant women (as defined in section 2112(d)) shall— 
‘‘(A) include coverage of mental health serv-
ices (including behavioral health treatment) nec-
essary 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 lin-
guistically 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 ‘‘para-
179 
graphs (5), (6), and (7)’’ and inserting ‘‘para-
graphs (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 in-
serting ‘‘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.—Subpara-
graph (A) of paragraph (7) of section 2103(c) of the Social 
Security Act (42 U.S.C. 1397cc(c)) (as redesignated by sub-
section (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